Theranos 2567 04-25-2016

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PRiNTED: 01/26/2016
DEPARTMENT OF HEALTH AND HUMAN SERVICES. FORM APPROVED
CENTERS FOR MEDiCARJ: & MEDICAID SERVICES OMB NO. 0938~0391
:I~.'I:ATEMENT:()F DEFIQIENOIES ()(1) .PRQV113ER/$1,JPPLIE.R7CLIA Q<?) MULT!PLE:CONStRllCTlON (X3) OATE SURVfN
.V' ''1PLAN 0:F CORRECTION IDE:NTIFlCA'flON NUMBER: A. EiUl(P.lNG _ _ _ _ _ _---'-_ . COMPLETEb
t
B.. WING _ _ _ _ _ _ _ __
05020257.1.4 11/20/2015
NAME OF PRO\ilDEROR SUPPLIER STREET ADDRESS; CITY; STATE. ZIP COJ;)E
· 7333 GATEWAY BLVD
TliERANOS INC
NEWARK, CA 9.4560.
(X?).!D SUMMARYSTATgMENT !'.)FbEFiCIENClES. 10 PROVIDER'S PLAN OF CORRECTION (XS) ..
PREFIX {g-AC,J-l DEflCIENCY MUST BE PRECEDED BY FULL PREFIX (i:,ACH CORR~CTIVEAGT!ON SflOULD BE . COMP~cTlON
OATE .
TAG . REGULATORY OR LSC lDENTIFYING INFO.RMATION) TAG CROSS;REFERF.NCEO TO THE APPROPRIATE
DEFICIENCY)
-
02094 493,841 (a) ROUTINE CHEMISTRY o;we4 D2094
(1 ). for any uns~isfactory a'nc!lyte or test the lab has investigated this ungraded
2/12/16
1
perfqrmance or testing event for reasom,1 other .PT event for ALP and has documented
than a failure to participate, the,laboratory must its investigation and conc)usion:;.
undertake appropriate trainlng and emplo,y the
teohrtir;al assisfamoe ne0$ssary to c<irrec.~t .· • • The new li:!b director has approved
pro,blems assoct-ated With a prof[cienoy t~st1ri;g
failure. enhanced procedures for prbficiency
(2) For any unacceptable analyte or testing event .testing, which l'einforcethe lab's
soore; remedial actlon must be taken :and systems for the.investigation of
documented; .and the d6.cumehtation must b.e 1ID.,grade.d ,PT results. The fab •s
.maintained by the l!:iboratory tor two years from technical supervisors will be
thf;! date of participation in tMiptoflofency testing
event respunsibfo for ensuring that these
This StAN:DARO ls· not met as evidenced by: proce4utes are itnpl¢1rte;nted and
B.ased on review of proficiency testing {PTI followed.
ct·ooutiientatlon and lntervlejl' with the General
sup1;3rvisor (GS), 'the laboratory failed to The lab will provide oversigbt thr01.J,gh
lnvei;itrgate and dqoumenfthe lnvestation .df monthly QA meetings by revi¢wing
ungraded alk-aflne phosphatase (ALP) Pf results
for the 3rd event of 2014. Findings triclude::
investig.a,tions and:corrective .action
for t.m,grli}de<;l p.roficiency tests with
a. The laboratory was E!nroUed With the conege "outcomes of less, than 100%. In
of American Patl1ologlsts {CAP) Pi- progrE!m for adqitfon, th9 lab will monitor,
ALP for the·a'rd event 2014. compliance through its improved
o<;cun:ence management, and audit
b. The CAP results showed JhaUlve. oflive
$amples(GHMw06 t~rough CHM~10) were procedru:es..
ungradedwlffr:a code [ZO); .'
c, There was no dacumenation that the

u:ngrade.dALP results had heeri investigated.
d.. The general ~upervlsorstated'tha:ttfie Quallty

w Control/Quality Assumnce (QC/QA) Mt';lnagerwas
responsible for investigating ungraded Pt results,
e. The QC/QA.Manger confirmed .on 11/18/15

that an i'nve:stigalloh '#1:}s not dcine or
LAaORATORY DIRECTOR'S ORPROYJPEfi!Sl:JPPIJl::'R REPRE§ENl'!\TIVE'S ·Sl(:lNATURE TITI.E (X6}DATE
King shU k Das
.· .. · . . · · ,· ·
Digitally sl~nrd byl<ingsnuk Diis
Dat~:2016.{!;2: 12 1.Qi18~05 °08'00' Lab Dfrector 2/12/16
r,. . .
Any deficiency statement ending w!lh ~n ~sterlsk (*) denotes a d:etlclenoy whloh the lnstitullon may .be excus.ed from correclliiQ providing lt ls-determ fned that
r$afe11.uards pr\lV!de .suffl<ilent. pr.otection to the. patients. (See: lnstr:uc.Uo11s.). Exceptfor nul'Slng .homes, the findings state:d above ar.e dlscilosab.le 90 'days
!l 1lng the date of sutl/eywliethet-or not a plan .ofcorrecilciil fs ptbvlded .. For nursing horn.es, (he aboveflndlngs ahd plans. ofcorrectlonare disdlosable 14
'li...,1 .s fi:lllowlhg l)ie date these document!> are made available to the faf!llly. If deficletitiles lire cited; an approved plan of correction Is requisite lb continued
progra~ partlbip.atlon. · · · · ·
FORM CMS,2:S6.7(Q2~99) ·Ptevtous Versions Qbsolet!3·• Evenl'ID;WS4211 FacliftylO: CA2204ll272 Jr continuation sheet Page 1 of 121
CONFIDENTIAL COMMERCIAL INFORMATION EXEMPT FROM DISCLOSURE UNDER THE FREEDOM OF INFORMATION ACT
PRINTED: 01/25/2016
DEPARTMENT OF HEALTH AND HUMAN SERVICES FORM APPROVED
CENTERS FOR MEDICARE & MEDICAID SERVICES OMB NO 0938-0391
!fff:: STATEMENT OF DEFICIENCIES {X1) PROVIDER/SUPPLIER/CUA (X2) MULTIPLE CONSTRUCTION {X3) DATE SURVEY
\;j;;j •AND PLAN OF CORRECTION IDENTIFICATION NUMBER: A. BUILDING _ _ _ _ _ _ __ COMPLETED
0502025714 B. WING _ _ _ _ _ _ _ __
11/20/2015
NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE
7333 GATEWAY BLVD
THERANOS INC
NEWARK, CA 94560
{X4)1D SUMMARY STATEMENT OF DEFICIENCIES ID PROVIDER'S PLAN OF CORRECTION (X5)
PREFIX (EACH DEFICIENCY MUST BE PRECEDED BY FULL PREFIX {EACH CORRECTIVE ACTION SHOULD BE COMPLETION
REGULATORY OR LSC IDENTIFYING INFORMATION) TAG CROSS-REFERENCED TO THE APPROPRIATE OATE
TAG
DEFICIENCY)
02094 Continued From page 1 02094

documented.
02128 493.851(e) HEMATOLOGY 02128 D2128 2/12/16
(1) For any unsatisfactory analyte or test Two out of two challenges for "Blood
performance or testing event for reasons other Cell ID (Educational)" were "Not
than a failure to participate, the laboratory must Graded" for the second API event of
undertake appropriate training and employ the 2014. The lab has investigated this
technical assistance necessary to correct
ungraded PT event and documented its
problems associated with a proficiency testing
failure. investigation and conclusions.
(2) For any unacceptable analyte or testing event
score, remedial action must be taken and Four out of five challenges for "Blood
documented, and the documentation must be Cell Identification" were acceptable
maintained by the laboratory for two years from for the second API event of 2014,
the date of participation in the proficiency testing
event.
meaning that the PT event received a
This STANDARD is not met as evidenced by: passing grade. The lab has
Based on review of proficiency testing (PT) investigated the one unacceptable
documentation and interview with the General challenge and documented its
Supervisor (GS), the laboratory failed to investigation and conclusions.
investigate and document the investigation of
ungraded blood cell identification PT results and
failed to investigate and document the
The new lab director has approved
investigation of an unsatisfactory blood cell enhanced procedures for pro.ficiency
identification PT result for the 2nd event of 2014. testing, which reinforce the lab's
Findings include: systems for investigation of ungraded
PT results and any challenges that
a. The laboratory was enrolled with the receive an unacceptable grade. The
American Proficiency Institute (API) PT program
for blood cell identification for the 2nd event 2014.
lab's technical supervisors are
responsible for ensuring that these
b. The API results showed that two of five procedures are implemented and
samples (BCl-13, BCl-14) were ungraded. followed.
c. The API results showed that BCl-11 was The lab will provide oversight through
graded as "unacceptable."
monthly QA meetings by reviewing
d. There was no documenation that the investigations and corrective action
FORM CMS-2567(02-99) Previous Versions Obsolete Event ID:W34211 Facility ID: CA22046272 If continuation sheet Page 2 of 121
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PRINTED: 01/25/2016
STATEMENT OF DEFICIENCIES (X1) PROVIDER/SUPPLIER/CUA (X2) MULTIPLE CONSTRUCTION (X3) DATE SURVEY
AND PLAN OF CORRECTION IDENTIFICATION NUMBER: A. BUILDING _ _ _ _ _ _ __ COMPLETED
0502025714 B. WING _ _ _ _ _ _ _ __
11/20/2015
7333 GATEWAY BLVD
THERANOSINC
NEWARK, CA 94560
(X4) ID SUMMARY STATEMENT OF DEFICIENCIES ID PROVIDER'S PLAN OF CORRECTION (XS)
PREFIX (EACH DEFICIENCY MUST BE PRECEDED BY FULL PREFIX (EACH CORRECTIVE ACTION SHOULD BE COMPLETION
REGULATORY OR LSC IDENTIFYING INFORMATION) CROSS-REFERENCED TO THE APPROPRIATE DATE
TAG TAG
DEFICIENCY)

D2128 (continued)
ungraded and unsatisfactory results had been
for proficiency tests with outcomes of
investigated.
less than 100% or challenges that are
e. The general supervisor stated that the Quality ungraded. In addition, the lab will
Control/Quality Assurance {QC/QA) Manager was monitor compliance through its
responsible for investigating ungraded PT results. improved occurrence management and
audit procedures.
f. The QC/QA Manger confirmed on 11 /18/15
that an investigation was not done or
documented.
05024 493.1215 HEMATOLOGY 05024
D5024 2/12/16
If the laboratory provides services in the specialty The laboratory has completed
of Hematology, the laboratory must meet the assessments to identify any patients
requirements specified in §§493.1230 through
493.1256, §493.1269, and §§493.1281 through
affected or having the potential to be
493.1299. affected by the issues identified in this
observation, and has taken corrective
and preventative action. Among other
This CONDITION is not met as evidenced by: things, the lab has hired a new lab
Based on the number and severity of the director and established improved
deficiencies cited herein, the Condition:
Hematology was not met. The laboratory failed to
quality systems and procedures
have a procedure manual which included the addressing the issues identified in this
corrective action to take when complete blood observation. (D5403, D5437, D5447,
counts (CBC) calibration and quality control (QC) D5469, D5481, D5779, D5801).
results failed to meet the laboratory's criteria for
acceptability (see 05403); document CBC
calibrations (see 05437); include two QC
materials with differing white blood cell (WBC)
patterns each day of testing (see 05447); verify
stated values of commercially assayed CBC
controls {see 05469); ensure QC for PT/INR was
acceptable prior to reporting patient test results
(see 05481); follow corrective action policies and
procedures as necessary to maintain the
laboratory operation for testing patient CBC
specimens in a manner that ensured accurate
FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: W34211 Faclllty ID: CA22046272 If continuation sheet Page 3 of 121
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PRINTED: 01/25/2016
STATEMENT OF DEFICIENCIES (X1) PROVIDER/SUPPLIER/CLIA (X2) MULTIPLE CONSTRUCTION (X3) DATE SURVEY
0502025714 B. WING _ _ _ _ _ _ _ __
11/20/2015
7333 GATEWAY BLVD
THERANOSINC
NEWARK, CA 94560
(X4) ID SUMMARY STATEMENT OF DEFICIENCIES ID PROVIDER'S PLAN OF CORRECTION (X5)
TAG TAG
DEFICIENCY)

and reliable patient test results and reports (see
05779); have an analytic systems quality
assessment mechanism that included a review of
the effectiveness of the laboratory's CBC
processes and flow cytometer corrective actions
taken to resolve problems (see 05779); and
ensure that the calculated International
Normalized Ratio (INR) results were accurate
prior to reporting final patient results (see 05801 ).
05217 493.1236(c)(1) EVALUATION OF PROFICIENCY 05217 D5217
TESTING PERFORMANCE Troponin I results for the second event 2/12/16
of 2014 were "Not Graded" due to
At least twice annually, the laboratory must verify "No Consensus" for all challenges.
the accuracy of any test or procedure it performs The lab has investigated this ungraded
that is not included in subpart I of this part.
/ This STANDARD is not met as evidenced by:
PT event and documented its
i. Based on review of proficiency testing records investigation and conclusions.
and interview with the General Supervisor, the
laboratory failed to investigate and document an The new lab director has approved
investigation of ungraded troponin proficiency enhanced procedures for proficiency
testing (PT) results from the 2nd event 2014. testing, which reinforce the lab's
Findings include:
systems for investigation of ungraded
a. The laboratory was enrolled in proficiency PT results. The lab's technical
testing for troponin with the American Proficiency supervisors are responsible for
Institute (API) for the 2nd event 2014. ensuring that these procedures are
implemented and followed.
b. Troponin results for five of five specimens
(CM-06 through CM-10) were ungraded by API.
The lab will provide oversight through
c. There was no documentation that the monthly QA meetings by reviewing
ungraded results had been investigared or investigations and corrective action
reviewed by the laboratory personnel. for ungraded proficiency tests. In
addition, the lab will monitor
d. The general supervisor stated that the Quality compliance through its improved
Control/Quality Assurance (QC/QA) Manager was
responsible for investigating ungraded PT results.
FORM GMS-2567(02-99) Previous Versions Obsolete Event ID:W34211 Facility ID: GA22046272 If conlinuatiori sheet Page 4 of 121
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PRINTED: 01/25/2016
{%') STATEMENT OF DEFICIENCIES (X1) PROVIDER/SUPPLIER/CLIA (X2) MULTIPLE CONSTRUCTION (X3) DATE SURVEY
~{D , AND PLAN OF CORRECTION IDENTIFICATION NUMBER: A. BUILDING _ _ _ _ _ _ __ COMPLETED
0502025714 B. WING _ _ _ _ _ _ _ __
11/20/2015
7333 GATEWAY BLVD
THERANOSINC
NEWARK, CA 94560
REGULATORY OR LSC IDENTIFYING INFORMATION) TAG CROSS-REFERENCED TO THE APPROPRIATE DATE
TAG
DEFICIENCY)
05217 Continued From page 4

e. The QC/QA Manger confirmed on 11/18/15
that an investigation was not done or
documented.
05311 493.1242(a) SPECIMEN SUBMISSION, 05311 D53 ll
HANDLING, AND REFERRAL As noted in the findings, it was the 2/12/16
110H practice of the lab to label all patient
120H The laboratory must establish and follow written specimens with lab-generated bar
140H policies and procedures for each of the following,
2108 codes issued at the point of collection.
if applicable:
2208 (1) Patient preparation. Those bar codes and related software
3108 properly tracked patient specimens.
320M
(2) Specimen collection.
3308 (3) Specimen labeling, including patient name or
3408 unique patient identifier and, when appropriate, The new lab director has approved
4008 specimen source. written policies and procedures
510M (4) Specimen storage and preservation.
(5) Conditions-for specimen transportation.
addressing patient specimen labeling.
(6) Specimen processing. The lab's supervisors, quality systems
(7) Specimen acceptability and rejection. director, and lab director will be
(8) Specimen referral. responsible for ensuring that these
This STANDARD is not met as evidenced by: procedures are implemented and
Based on laboratory personnel interviews and followed.
pre-analytic policies and procedures record
review on September 23, 2015, the laboratory
failed to establish written policies and procedures The lab will provide oversight of
for patient specimen labeling. Findings included: accessioning through monthly QA
meetings. In addition, the lab will
a. It was the practice of the laboratory to require monitor compliance through its
that all patient specimens received be labeled improved occurrence management,
with laboratory generated bar codes that were
issued at the point of specimen collection. and audit procedures, both of which
address preanalytic activities.
b. The laboratory maintained no written policies
and procedures detailing this patient specimen
labeling policy and procedure.
c. According to laboratory records, the

laboratory performed approximately 890,000
patient tests annually.
(.
<
PRINTED: 01/25/2016
[ } } STATEMENT OF DEFICIENCIES (X1) PROVIDER/SUPPLIER/CUA (X2) MULTIPLE CONSTRUCTION (X3) DATE SURVEY
I':( ) PLAN OF CORRECTION IDENTIFICATION NUMBER: A. BUILDING _ _ _ _ _ _ __ COMPLETED
0502025714 B. WING _ _ _ _ _ _ _ __
11/20/2015
7333 GATEWAY BLVD
THERANOSINC
NEWARK, CA 94560
TAG TAG
DEFICIENCY)
D5391 #1
05391 493.1249(a) PREANALYTIC SYSTEMS QUALITY 05391
ASSESSMENT As noted in the findings, if a patient 2/12/16
110H specimen did not meet the lab's
120H The laboratory must establish and follow written acceptance criteria, the lab's practice
140H policies and procedures for an ongoing was to describe the issue in its
2108 mechanism to monitor, assess, and when
2208
electronic system, to notify relevant
indicated, correct problems identified in the lab personnel, and to take, and
3108
320M
preanalytic systems specified at §§493.1241
through 493.1242. electronically note, appropriate
3308
3408
corrective action. Patient specimens
4008 This STANDARD is not met as evidenced by: that did not meet the lab's acceptance
510M criteria were not used for testing.
1. Based on laboratory personnel interviews and
pre-analytic remedial action record review on
September 23, 2015, the laboratory failed to
establish written policies and procedures for an enhanced specimen rejection
ongoing mech.anism to monitor, assess, and procedures, which require the relevant
when indicated, correct problems identified in the lab personnel to further monitor and
laboratory's preanalytic systems when received assess received patient specimens and
patient specimens did not meet the laboratory's to correct problems as needed. These
criteria for acceptability. Findings included:
procedures also require a supervisor to
a. According to laboratory personnel, during the review and approve daily a list of
accessioning of patient specimens, if a patient requested redraws. The lab has
specimen was received that did not meet the conducted training on these ·
laboratory's criteria for acceptability, a description procedures.
as to why the specimen did not meet the
laboratory's criteria for acceptability would be
electronically noted, applicable laboratory During monthly QA meetings, the lab
personnel would be notified, appropriate will review, among other things,
corrective actions would be taken and specimen rejection rates and any
electronically noted, and the incident would be associated issues. In addition, the lab
captured for quality assessment review. will monitor compliance through its
improved occurrence management,
and procedures detailing this quality assessment and audit procedures, both of which
process. address preanalytic activities.
c. According to laboratory records, the The new lab director is responsible for
laboratory performed approximately 890,000
I
i
PRINTED: 01/25/2016
,t@) STATEMENT OF DEFICIENCIES (X1) PROVIDERISUPPLIERICLIA (X2) MULTIPLE CONSTRUCTION {X3) DATE SURVEY
\]@{;. AND PLAN OF CORRECTION IDENTIFICATION NUMBER: A. BUILDING _ _ _ _ _ _ __ COMPLETED
0502025714 B. WING _ _ _ _ _ _ _ __
11/20/2015
7333 GATEWAY BLVD
THERANOS INC
NEWARK, CA 94560
{X4)1D SUMMARY STATEMENT OF DEFICIENCIES ID PROVIDER'S PLAN OF CORRECTION (XS)
TAG
DEFICIENCY)

D5391 #1 (continued)
the lab's QA program, and has also
2. Based on laboratory personnel interviews and appointed a Quality Director who will
patient specimen referral policies and procedures provide additional oversight.
record review on September 23, 2015, the 2/12/16
laboratory failed to establish written policies and D5391 #2
procedures for an ongoing mechanism to As noted in the findings, the lab's
monitor, assess, and when indicated, correct
problems identified in the laboratory's preanalytic practice was to review its log of
systems for patient specimens referred to other patient specimens referred to other
laboratories for testing. Findings included: labs to ensure the timely receipt and
reporting of the test results performed
a. According to laboratory personnel, a log of by the other labs.
patient specimens referred to other laboratories
for testing was reviewed daily to ensure the timely
receipt and reporting of the test results performed The new lab director has approved
by the other laboratories. enhanced procedures for referral
testing, which require, among other
b. The laboratory maintained no written policies things, the lab to document its review
and procedures detailing this quality assessment of pending orders and results for
process. ref~rral test~, including the lab's log of
05393 493.1249{b)(c) PREANALYTIC SYSTEMS 05393
QUALITY ASSESSMENT patient specrmens referred to other
110H labs.
120H The preanalytic systems assessment must
140H include a review of the effectiveness of corrective The lab's management, including the
2108 actions taken to resolve problems, revision of
2208 lab director and quality systems
policies and procedures necessary to prevent director, is responsible for monitoring
3108
320M
recurrence of problems, and discussion of
preanalytic systems quality assessment reviews and assessing compliance with these
3308
3408 with appropriate staff. The laboratory must procedures, and ensuring that
4008 document all preanalytic systems quality corrective action is taken as needed.
510M assessment activities. The lab also requires monitoring of
turnaround times for reference labs
This STANDARD is not met as evidenced by: and related issues during monthly QA
Based on laboratory personnel interviews and
patient specimen referral policies and procedures meetings, through regular audits, and
record review on September 23, 2015, the through its improved occurrence
management.
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PRINTED: 01/25/2016
0502025714 B. WING _ _ _ _ _ _ _ __
11/20/2015
7333 GATEWAY BLVD
THERANOS INC
NEWARK, CA 94560
TAG
DEFICIENCY)
05391 Continued From page 6 05391 (C onmue

t' d)

patient specimen referral policies and procedures
record review on September 23, 2015, the
laboratory failed to establish written policies and
procedures for an ongoing mechanism to
monitor, assess, and when indicated, correct
problems identified in the laboratory's preanalytic
systems for patient specimens referred to other
laboratories for testing. Findings included:
a. According to laboratory personnel, a log of

patient specimens referred to other laboratories
receipt and reporting of the test results performed
by the other laboratories.

and procedures detailing this quality assessment
process.
05393 493.1249{b){c) PREANALYTIC SYSTEMS 05393 D5393
QUALITY ASSESSMENT As noted in the findings, the lab's 2/12/16
110H practice was to review its log of
120H The preanalytic systems assessment must patient specimens referred to other
140H include a review of the effectiveness of corrective labs to ensure the timely receipt and
2108 actions taken to resolve problems, revision of
2208
reporting of the test results performed
policies and procedures necessary to prevent by other labs.
3108
320M
recurrence of problems, and discussion of
3308 preanalytic systems quality assessment reviews
3408 with appropriate staff. The laboratory must The new lab director has approved
4008 document all preanalytic systems quality enhanced procedures for referral
510M assessment activities. testing, which require, among other
things, that review of referral testing
This STANDARD is not met as evidenced by: logs will be documented.
patient specimen referral policies and procedures
record review on September 23, 2015, the
FORM CMS-2567(02-99) Previous Versions Obsolete Event IO:W34211 Faclllty ID: CA22046272 If continuation sheet Page 7 of 121
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PRINTED: 01/25/2016
tfiW: STATEMENT OF DEFICIENCIES (X1) PROVIDER/SUPPLIER/CLIA (X2) MULTIPLE CONSTRUCTION (X3) DATE SURVEY
~w:w AND PLAN OF CORRECTION IDENTIFICATION NUMBER: A. BUILDING _ _ _ _ _ _ __ COMPLETED
0502025714 B. WING _ _ _ _ _ _ _ __
11/20/2015
7333 GATEWAY BLVD
THERANOSINC
NEWARK, CA 94560
TAG
DEFICIENCY)

D5393 (continued)
laboratory failed to document all preanalytic
systems quality assessment activities, specifically
The lab's management, including the
for patient specimens referred to other lab director and quality systems
laboratories for testing. Findings included: director, is responsible for overseeing
compliance with these procedures.
a. According to laboratory personnel, a log of The lab also requires monitoring of
patient specimens referred to other laboratories turnaround times for reference labs
receipt and reporting of the test results performed and related issues during monthly QA
by the other laboratories. meetings, through regular audits, and
through its improved occurrence
b. The laboratory maintained no documentation management.
indicating that the patient specimen referral log
was reviewed daily.
05400 493.1250 ANALYTIC SYSTEMS o54 oo D5400 2/12/16
Each laboratory that performs nonwaived testing The laboratory has completed
must meet the applicable analytic systems assessments to identify any patients
requirements in §§493.1251 through 493.1283, affected or having the potential to be
unless HHS approves a procedure, specified in affected by the issues identified in this
Appendix C of the State Operations Manual (CMS observation, and has taken corrective
Pub.7), that provides equivalent quality testing.
The laboratory must monitor and evaluate the and preventative action. Among other
overall quality of the analytic systems and correct things, the lab has hired a new lab
identified problems as specified in §493.1289 for director and established improved
each specialty and subspecialty of testing quality systems and procedures
performed. addressing the issues identified in this
observation. (D5403, D5407, D5413,
This CONDITION is not met as evidenced by:
Based on the number and severity of the D5421, D5423, D5429, D5437,
deficiencies cited herein, the Condition: Analytic D5447, D5449, D5469, D5477,
Systems was not met. The laboratory failed to D5481, D5775, D5779, D5787,
have a procedure manual that included corrective D5791, D5793).
action for chemistry quality control (QC) (see
05403); failed to have procedures signed, dated,
and approved by the laboratory director prior to
use (see 05407); failed to have freezer
temperature consistent with manufacturer
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PRINTED: 01/25/2016
AND PLAN OF CORRECTION COMPLETED
~r1Iwt IDENTIFICATION NUMBER:
A. BUILDING
0502025714 B.WING 11/20/2015

7333 GATEWAY BLVD
THERANOSINC
NEWARK, CA 94560
TAG
DEFICIENCY)

requirements (see 05413); failed to verify
performance specifications on the Advia XPT
(see 05421); failed to establish performance
specification when the alkaline phosphatase test
system was modified (see 05423); failed to
perform weekly maintenance on the Evolis (see
05429); failed to document hematology
calibration (see 05437); failed to include two
quality control materials at least once each day
WBC differentials were performed (see 05447);
failed to include positive quality control materials
each day patient specimens were assayed (see
05449); failed to verify the criteria for
acceptability of quality control materials for
,,,·
hematology and chemistry (see 05469); failed to
( check blood agar plates for its ability to support
growth (see 05477); failed to ensure that QC test
results met the laboratory's criteria for
acceptability for Prothrombin Time/International
Normalized Ratio and the Theranos Proprietary
System (TPS) prior to reporting patient test
results (see 05481); failed to have a system that
twice per year evaluated and defined the
relationship for WBC differentials and the TPS
(see 05775); failed to follow hematology
corrective action policies and procedures (see
05779); failed to have a record system that
documented the lot number of media used to test
patient bacteriology specimens (see 05787);
failed to follow quality assessment (QA) policies
and procedures (see 05791 ); and failed to
monitor the effectiveness of corrective actions
and revise policies and procedures to prevent
recurrence of problems (see 05793). D5403 #1:
05403 493.1251(b) PROCEDURE MANUAL 05403
The laboratory proactively paused 2/12/16
400M The procedure manual must include the following testing on the Advia 2120i during the
when applicable to the test procedure: survey. The lab has completed an
(
I\
.L:)V NOI.LVW110dNI dO WOQ3ffild 3HL 113CINfl ffilflS01:JSIQ W011d .LdW3X3 NOI.LVW110dNI 1YD113WWO:J 1VI.LN3GidNO:J
PRINTED: 01/25/2016
PLAN OF CORRECTION IDENTIFICATION NUMBER: A. BUILDING _ _ _ _ _ _ __ COMPLETED
0502025714 B. WING _ _ _ _ _ _ _ __
11/20/2015
7333 GATEWAY BLVD
THERANOSINC
NEWARK, CA 94560
PREFIX (EACH DEFICIENCY MUST BE PRECEDED BY FULL PREFIX (EACH CORRECTIVEACTION SHOULD BE COMPLETION
TAG REGULATORY OR LSC IDENTIFYING INFORMATION) CROSS-REFERENCED TO THE APPROPRIATE DATE
TAG
DEFICIENCY)

o54 o3 D5403 #1 (continued)
(1) Requirements for patient preparation;
specimen collection, labeling, storage, assessment to identify any patients
preservation, transportation, processing, and affected or having the potential to be
referral; and criteria for specimen acceptability affected by this issue.
and rejection as described in §493.1242.
(2) Microscopic examination, including the The new lab director has approved
detection of inadequately prepared slides. enhanced QC procedures that address
(3) Step-by-step performance of the procedure,
Including test calculations and interpretation of the corrective actions to take when QC
results. fails to meet the lab's acceptability
(4) Preparation of slides, solutions, calibrators, criteria, and the lab has conducted
controls, reagents, stains, and other materials training on those procedures. The new
used in testing. lab director has also approved an
(5) Calibration and calibration verification
enhanced SOP for CBC on the
procedures.
(6) The reportable range for test results for the Siemens Advia 2120i that addresses
test system as established or verified in the corrective actions to take when
§493.1253. calibration or QC fail to meet the lab's
(7) Control procedures. acceptability criteria
(8) Corrective action to take when calibration or
control results fail to meet the laboratory's criteria
for acceptability.
Before the lab resumes any tests on
(9) Limitations in the test methodology, including the Siemens Advia 2120i, it will
interfering substances. conduct training on those procedures.
(10) Reference intervals (normal values). In addition, lab staff will be required
(11) Imminently life-threatening test results, or to demonstrate competency to ensure
panic or alert values. that practice is consistent with these
(12) Pertinent literature references.
(13) The laboratory's system for entering results procedures. In addition, prior to
in the patient record and reporting patient results resuming any test on this instrument,
including, when appropriate, the protocol for the lab will re-verified the test in
reporting imminently life threatening results, or accordance with its improved method
panic, or alert values. verification procedures.
(14) Description of the course of action to take if a
test system becomes inoperable.
Lab management, including the lab
This STANDARD is not met as evidenced by: director, technical supervisors, and
1. Based on laboratory personnel interviews and quality director, is responsible for
the laboratory's hematology Advia 2120i compliance with these procedures.
FORM CMS-2567(02-99) Previous Versions Obsolete Event JD:W34211 Faclllty JD: CA22046272 If continuation sheet Page 10 of 121
.L)V NOI.LVJAIBOdNI dO womn:rnd 3H.11:I'.3:GNfl ffilil.SO'I::)SIQ JAJ:01:Id .LdW'.3:X'.3: NOI.LVJAJ:1:IOdNI 'lVI::rn'.3:WJAJ:O;) '1\fl.LN'.3:CTidNO;)
PRINTED: 01/25/2016
,mm,
\JF
STATEMENT OF DEFICIENCIES
AND PLAN OF CORRECTION
(X1) PROVIDER/SUPPLIER/CUA
IDENTIFICATION NUMBER:
(X2) MULTIPLE CONSTRUCTION
A. BUILDING _ _ _ _ _ _ __
(X3) DATE SURVEY
COMPLETED
0502025714 B. WING _ _ _ _ _ _ _ __
11/20/2015
7333 GATEWAY BLVD
THERANOSINC
NEWARK, CA 94560
TAG
DEFICIENCY)
procedure record review on November 19, 2015,
o54 o3 The lab will provide oversight through
the laboratory failed to have a procedure manual
monthly QA meetings, and will
that included the corrective action to take when monitor compliance through its
calibration or quality control results failed to meet improved occurrence management,
the laboratory's criteria for acceptability. Findings and audit procedures.
included:
a. It was the practice of the laboratory to test

patient venous complete blood counts (CBC)
specimens using a SiemensAdvia 2120i
instrument.
b. In the laboratory's procedure titled "SOP

Advia 2120i Operation and Maintenance," there
was no written protocol for the corrective action to
,,
! be taken when calibration or quality control
\ results failed to meet the laboratory's criteria for
acceptability.
c. Between February 2015 and September 21,

2015, the laboratory performed and reported
2,395 patient CBC test results using the Advia
2120i.
2. Based on review of the quality control (QC) 2/12/16

procedure for the Edison 3.5 Theranos System D5403 #2
and documentation provided by the laboratory, The lab performed QC for the
• the laboratory failed to have a procedure for QC
prior to 5/15/2014. Findings include:
Theranos Sample Processing Unit 3.5
("TSPU 3.5") both before and after
a. CL SOP-15026 Revision A, "Edison 3.5 May 15, 2014. The lab has completed
Theranos System Daily QC Procedure" revealed an assessment to identify any patients
an effective date of 5/15/2014. affected or having the potential to be
affected by this issue.
b. A chart provided by the laboratory indicated
that eight of twelve analytes run on the above
system were put into use for patient testing prior The new lab director has approved
to 5/15/2014. The initial use dates of the eight enhanced QC procedures that address
analytes ranged from 11/6/2013 through the corrective actions to take when QC
FORM CMS-2567(02-99) Previous Versions Obsolete Event ID:W34211 Faclllty ID: CA22046272 If continuation sheet Page 11 of 121
.L)V NOI.L~OdNI dO WOQ3:tllid 3HL 1I3QNfl 31IflS0'1:JSIQ W01Id l.dW3X3 NOI.LVW1IOdNI '1VI:J1I3WWO:::> '1VI.LN3aidNO:::>
PRINTED: 01/25/2016
j:ffa/ STATEMENT OF DEFICIENCIES (X1) PROVIDER/SUPPLIER/CUA (X2) MULTIPLE CONSTRUCTION (X3) DATE SURVEY
'qjf AND PLAN OF CORRECTION IDENTIFICATION NUMBER: A BUILDING _ _ _ _ _ _ __ COMPLETED
0502025714 B. WING _ _ _ _ _ _ _ __
11/20/2015
7333 GATEWAY BLVD
THERANOSINC
NEWARK, CA 94560
TAG REGULATORY OR LSC IDENTIFYING INFORMATION) TAG CROSS-REFERENCED TO THE APPROPRIATE DATE
DEFICIENCY)
o54 o3fails to meet the lab's acceptability
5/9/2014.
cri!e:ia, and the lab has conducted
05407 493.1251(d) PROCEDURE MANUAL 05407
tra1mng on those procedures.
Procedures and changes in procedures must be
approved, signed, and dated by the current Lab management, including technical
laboratory director before use. supervisors, the lab director, and the
This STANDARD is not met as evidenced by: quality director, will be responsible
Based on review of procedures and interview
for ensuring compliance with these
with the technical supervisor, the current
laboratory director (LD) failed to sign, date and procedures. The lab will provide
approve procedures prior to use. Findings oversight through monthly QA
include: meetings, and will monitor
compliance through its improved
a. The current LO start date was 2/10/2015. occurrence management, and audit
b. Eight procedures were reviewed. Seven of procedures.
seven procedures did not include a LO signature
prior to putting into use and one of one was not
signed by the current LO.
c. CL SOP-09161, Revision A (Apolipoprotein)

showed an effective date of 12/5/2014, but was
not signed by the LO until 9/19/2015. It was
signed by a technical supervisors "for the LD."
The procedure was not signed, dated and
approved by any LO prior to 9/19/2015.
d. CL SOP-10001, Revision 8 (Measuring

Prothrombin Time-lnnovin (PT) on the Siemens
BCS XP Instrument) showed an effective date of
12/5/2014, but was not signed by the LO until
9/19/2015. The procedure was not signed, dated
and approved by any LO prior to 9/19/2015.
e. CL SOP-06060, Revision A (SensoScientific

Monitor) showed an effective date of 6/23/2015,
but was not signed by the LD until 9/22/2015.
FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: W34211 Facility ID: CA22046272 If continuation sheet Page 12 of 121
.L:JV NOI.L\IW1IOdNI dO WOG3ffild 3H.L ~3GNfl ffiIIl.S01;:)SIG WO~d .LdW3X3 NOI.LV~OdNI 1VI;:)~3WW0;:) 1VI.LN3GBN0;:)
PRINTED: 01/25/2016
STATEMENT OF DEFICIENCIES (X1) PROVIDER/SUPPLIER/CUA (X2) MULTIPLE CONSTRUCTION (X3) DATE SURVEY ·
f;ll 1 AND PLAN OF CORRECTION IDENTIFICATION NUMBER: A. BUILDING

COMPLETED
0502025714 B.WING 11/20/2015

7333 GATEWAY BLVD
THERANOS INC
NEWARK, CA 94560
(EACH DEFICIENCY MUST BE PRECEDED BY FULL (EACH CORRECTIVE ACTION SHOULD BE COMPLETION
PREFIX
TAG REGULATORY OR LSC IDENTIFYING INFORMATION) . PREFIX
TAG CROSS-REFERENCED TO THE APPROPRIATE
DEFICIENCY)
DATE
05403 Conti.nued From page 11 05403

5/9/2014.
05407 493.1251(d) PROCEDURE MANUAL 05407
D5407 2/12/16
Procedures and changes Tn procedures must be The lab directors during the period
approved, signed, and dated by the current covered by the survey no longer hold
laboratory director before use. any position with the lab. The new lab
This STANDARD is not met as evidenced by: director was hired after the on-site -
Based on review of procedures and interview
survey had been completed.
with the technical supervisor, the current
laboratory dire°'tor (LD) failed to sign, date and
approve procedures prior to use. Findings The new lab director has approved
.· include: enhanced document control policies
and procedures to ensure that the
a. The current LD start date was 2/10/2015. relevant personnel approve n~w or
revised documents before they
1 b. Eight procedures were reviewed. Seyen of
seven procedures did not include a LD signature become effective. The lab has
prior to putting into use and one of one was not conducted training on those
signed by the current LD. procedures.
c. CL SOP-09161, Revision A (Apolipoprotein) All active SOPs relevant to testing

showed an effective date of 12/5/2014, but was
currently being performed haye been
not signed by the LD until 9/19/2015. It was
signed by a technical supervisors "for the LD." approved by the new lab director.
The procedure was not signed, dated and
approved by any LD prior to 9/19/2015. The lab has appointed a Document
Control Manager whose
d. CL SOP-10001, Re.vision B (Measuring responsibilities include tracking new
Prothrombin Time-lnnovin (PT) on the Siemens
BCS XP Instrument) showed an effective date_of and revised policies and procedures to
12/5/2014, but was not signed by the LD until ensure they are reviewed, approved,
9/19/2015. The procedure was not signed, dated and signed by the lab director before
- ·~I
and approved by any LO prior to 9/19/2015. they become effective.
e. CL SOP-06060, Revision A (SensoScientific

The lab will provide oversight of
Monitor) showed an effective date of 6/23/2015,
but was not signed by the LO until 9/22/2015. document control through monthly
J.OV NOIJ.VJi'IBO!I.NI .ilO WOCT'tiffiI.il 'tIRL 1I'tICIN[l ffiiflSO'IOSICT W01III J.clW'tIX'tI NOIJ.VJi'IBOdNI 'IVI01ISWWOO 'IVIJ.N'tIGI.ilNOO
PRINTED: 01/25/2016
i(i::) STATEMENT OF DEFICIENCIES (X1) PROVIDER/SUPPLIER/CUA (X2) MULTIPLE CONSTRUCTION (X3) DATE SURVEY .
\)!@;) AND PLAN OF CORRECTION IDENTIFICATION NUMBER: A. BUILDING _ _ _ _ _ _ __ COMPLETED
0502025714 B. WING _ _ _ _ _ _ _ __
11/20/2015
7333 GATEWAY BLVD
THERANOSINC
NEWARK, CA 94560
TAG TAG
DEFICIENCY)
D5407 (continued)
05407 Continued From page 12 05407 QA meetmgs,
. and w1.11 momtor
.
f. CL SOP-15036, Revision A (Edison 3.5
Theranos System Daily QC Procedure) showed
compliance through its new audit
an effective date of 12/5/2014, but was not signed procedures.
by the LD until 9/19/2015.' The procedure was
not signed, dated and approved by any LO prior
to 9/19/2015.
g. CL PLN-14003, Revision A (Master Validation

Chemistry Assays on Theranos Devices) showed
an effective date of 11 /4/2911, but was not signed
by the LD until 9/19/2015. The procedure was
not signed, dated and approved by any LO prior
to 9/19/2015.
h. Three of three procedures for the Advia

Chemistry System (Glucose/CL SOP-09118,
Carbon Dioxide (C02)/CL SOP-09.111, Alkaline
Phosphatase/CL SOP-81102) were put into use in
December 2014. The C02 and alkaline
phosphatase procedures were not signed, dated
and approved by the LD ·until 9/19/2015. The
glucose procedure was not signed, dated and
approved by the LD.
05413 493.1252(b) TEST SYSTEMS, EQUIPMENT, 05413 D5413 #1
INSTRUMENTS,REAGENT A review of hourly data demonstrated 2/12/16
that average hourly temperature for
The laboratory must define criteria for those nearly all of the freezers at issue met
conditions that ate ess~ntial for proper storage of the manufacturer temperature
reagents and specimens, accurate and reliable
test system operation, and test result reporting. requirements for the materials stored.
The criteria must be consistent with the · The lab has identified and discarded
manufacturer's instructions, if provided. These any materials that had the potential to
conditions must be monitored and documented have been affected. The lab has also
and, if applicable, Include the following: completed an assessment to identify
(1) Water quality. any patients affected or having the
(2) Temperature."
(3) Humidity. potential to be affected by this issue.
(4) Protection of equipment and instruments from
CONFIDENTIAL COMMERCIAL INFORMATION EXEJ\.1PT FROM DISCLOSURE UNDER THE FREEDOM OF INFORMATION ACT
PRINTED: 01/25/2016
J@) STATEMENT OF DEFICIENCIES (X1) PROVIDER/SUPPLIER/CUA (X2) MULTIPLE CONSTRUCTION (X3) DATE SURVEY
Qd,U AND PLAN OF CORRECTION IDENTIFICATION NUMBER: A. BUILDING _ _ _ _ _ _ __ COMPLETED
0502025714 B. WING _ _ _ _ _ _ _ __
11/20/2015
7333 GATEWAY BLVD
THERANOSINC
NEWARK, CA 94560
(X4)1D SUMMARY STATEMENT OF DEFICIENCIES ID PROVIDER'S PLAN OF CORRECTION (X5)
TAG
DEFICIENCY)
fluctuations and interruptions in electrical current
that adversely affect patient test results and test
enhanced temperature management
reports. procedures to reinforce monitoring of
This STANDARD is not met as evidenced by: temperature and environmental
1. Based on observation and document review, conditions and storage of materials
the laboratory failed to define freezer temperature according to the manufacturer's
ranges that were consistent with the temperature range. The lab has
manufacturer's instructions for freezers which
stored reference materials and patient
conducted training on those
specimens. Findings include: procedures.
a. A tour of the laboratory where the freezers The lab's management, including the
were kept showed that the freezer doors were new lab director and quality systems
labeled with the laboratory's acceptable
director, will ensure compliance with
temperature ranges.
these procedures, including by making
/' b. Four of four -80 C freezers were marked with sure that supervisors perform their
a temperature range of -60 to -90 C. respective duties effectively. The lab
will also provide oversight through
c. Six of six -20 C freezers were marked with a monthly QA meetings, and will
temperature range of-17 to -25 C.
monitor compliance through its
d. Review of two manufacturer instructions for improved occurrence management,
samples stored in the -80 freezers required that and audit procedures. ·
the samples be kept at "at least -80 C."
e. Review of 3 manufacturer instructions for

samples stored in the -20 freezers required that
the samples be kept at "at least -20 C."
f. The Director of Assay Systems and technical

supervisor confirmed at 11/19/15 at
approximately 11 am that the freezers were
labeled with the above ranges and that the
ranges did not meet the manufacturers
instructions.
2. Based on review of the procedure,

manufacturer package insert (Pl) and
CONFIDENTIAL COMMERCIAL INFORMATION EXEMPT FROM DISCLOSURE UNDER TIIE FREEDOM OF INFORMATION ACT
PRINTED: 01/25/2016
~f' \ STATEMENT OF DEFICIENCIES (X1) PROVIDER/SUPPLIER/CUA (X2) MULTIPLE CONSTRUCTION (X3) DATE SURVEY
\j( AND PLAN OF CORRECTION IDENTIFICATION NUMBER: A. BUILDING _ _ _ _ _ _ __ COMPLETED
0502025714 B. WING _ _ _ _ _ _ _ __
11/20/2015
7333 GATEWAY BLVD
THERANOSINC
NEWARK, CA 94560
TAG TAG
DEFICIENCY)
D5413 #2 2/12/16
This PT/INR issue related to one lot.
observation, the laboratory failed to follow the
manufacturer instructions for expiration date of
The lab paused testing on the Siemens
lnnovin (thromboplastin) used for Prothrombin BCS XP, including PT/INR, during
Time/International Normafized Ratio (PT/INR) the survey. The lab has completed an
testing. Findings.include: assessment to identify any patients
affected or having the potential to be
a. Dade lnnovin (thromboplastin) lot number affected by this issue. ·
539280 was put into use by the laboratory at the
end of March 2015.
\ '
b. The general supervisor stated that the enhanced reagent qualification and
package inserts were usually white. management procedures that reinforce
the lab's practice of ensuring that
c. The package insert for lot number 539280 manufacturer inserts and notifications
was pink whJch indicated that the manufacturer
had included special instructions for the specific are reviewed and followed. The lab
lot number of lnnovin. · has conducted training on those
procedures.
d. Review of the Pl revealed an "important note"
that this specific lot number was only stable for 2 Before the lab resumes PT/INR
days instead of 10 days after reconstitution when
stored at 2-8 C.
testing, the lab will reinforce with
relevant testing personnel the
e. The current vial of lnnovin reagent was importance of reviewing and ·
observed in the 2-8 C refrigerator with a 5 day following instructions on
expiration date. manufacturer inserts and notifications,
including instructions concerning
f. CL SOP-10001 Reyision A, "Measuring
Prothrombin Time ... " stated on page 10, section
expiration dates. The same type of
12.1 that "the package insert for a new lot must training will occur for personnel
be reviewed for any changes before use. 11 - conducting other tests. These
trainings, along with competency
g. The general supervisor confirmed on 9/23/15 testing, will ensure that practice is
that the change in storage and stability of the consistent with these procedures.
lnnovin reagent had not been identified from
March 2015 through September 2015.
05421 493.1253(b)(1) ESTABLISHMENT AND 05421 Lab management, including the new
VERIFICATION OF PERFORMANCE lab director, technical supervisors, and
CONFIDENTIAL COMMERCIAL INFORMATION EXEJ\.1PT FROM DISCLOSURE UNDER THE FREEDOM OF INFORMATION ACT
PRINTED: 01/25/2016
STATEMENT OF DEFICIENCIES (X1) PROVIDER/SUPPLIER/CUA (X2) MULTIPLE CONSTRUCTION (X3) DATE SURVEY -
0502025714 B. WING _ _ _ _ _ _ _ __
11/20/2015
7333 GATEWAY BLVD
THERANOSINC
NEWARK, CA 94560
TAG TAG
DEFICIENCY)
05413 Conti_nued From page 14 05413
quality director, is responsible for
observation, the laboratory failed to follow the
manufacturer instructions for expiration date of
ensuring that these procedures are
lnnovin (thromboplastin) used for Prothrombin followed. The lab will provide
Time/International Normattzed Ratio (PT/INR) oversight through monthly QA
testing. Findings· include: meetings, and will monitor
a. Dade lnnovin (thromboplastin) lot number occurrence management, and audit
539280 was put into use by the laboratory at the
end of March 2015. procedures.
b. The generJI supervisor stated that the

package inserts were usually white.
c. The package insert for lot number 539280

was pink which indicated that the manufacturer
had included special instructions for the specific
lot number of lnnovin. ·
d. Review of the Pl revealed an "important note"

that this specific lot number was only stable for 2
days instead of 10 days after reconstitution when
stored at 2-8 C.
e. The current vial of lnnovin reagent was

observed in the 2-8 C refrigerator with a 5 day
expiration date.
f. CL SOP-10001 Revision A, "Measuring

Prothrombin Time ... " stated on page 10, section
12.1 that "the package insert for a new lot must
be reviewed for any changes before use."
g. The general supervisor confirmed on 9/23/15

that the change in storage and stability of the
lnnovin reagent had not been identified from
March 2015 through September 2015.
05421 493.1253(b)(1) ESTABLISHMENT AND 05421
VERIFICATION OF PERFORMANCE
FORM CMS-2567(02-99) Previous Versions Obsolete Event ID:W34211 Facility JD: CA22046272 If continuation sheet Page 15 of 121
J.::)V NOIJ.Vli'ffiOilNI ilO WOCTHffilil HHJ. 1IHCINfl ffiID.SO'I::)Sia W01Iil J.dJAJIIXH NOIJ.Vli'ffiOiINI 'IVI::)1IHWYl!0::) 'IVIJ.NHOI.ilNO::)
PRINTED: 01/25/2016
~@)\' STATEMENT OF DEFICIENCIES (X1) PROVIDERJSUPPLIER/CLIA (X2) MULTIPLE CONSTRUCTION (X3) DATE SURVEY
\%)$ AND PLAN OF CORRECTION IDENTIFICATION NUMBER: A. BUILDING _ _ _ _ _ _ __ COMPLETED
0502025714 B. WING _ _ _ _ _ _ _ __
11/20/2015
7333 GATEWAY BLVD
THERANOSINC
NEWARK, CA 94560
TAG
DEFICIENCY)
D5421 #1:
05421 Continued Fro_m page 15 05421
The lab proactively paused testing on 2/12/16
Each laboratory that introduces an unmodified,
the Advia XPT during the survey.
FDA-cleared or approved test system must do the The lab has completed an assessment
following before reporting ..patient test results: to identify any patients affected or
(1 )(i) Demonstrate that·it can obtain performance having the potential to be affected by
specifications comparable to those established by this issue.
the manufacturer for the following performance
characteristics:
(1)(i)(A) Accuracy. Before the lab resumes any test on the
(1 )(i)(B) Precision. Advia XPT, the lab will ensure that
(1 )(i)(C) Reportable range·of test results for the the test has been re-verified pursuant
test system. to the lab's improved method
(1)(ii) Verify that the manufacturer's reference verification procedures that have been
intervals (normal values) are appropriate for the approved by the new lab director.
laboratory's patient population.
This STANDARD is not met as evidenced by: These improved procedures reinforce
1. Based on review of the performance · that the lab's testing personnel are
specification verification documentation and required to actively participate in
interview with the general supervisor and method verification and document
technical supervisor, the laboratory failed to their participation.
maintain any documentation that the laboratory
had participated in conducting the verification of
the performance specifications on the Advia XPT. Before any verification studies are
Findings include: performed, these improved procedures
require the lab director's review and
a. The general supervisor and techincal approval of a detailed method
supervisor stated that the manufacturer verification plan containing defined
performed all of the performance specification
verification activities on· the Advia XPT. acceptance criteria. The lab director
must also review and approve the
b. They further stated that the laboratory staff verification report before any patient
were available to prepare quality control material testing begins.
and gathering patient samples for the
manufacturer representative to perform the The lab has conducted training on
verification.
these procedures to ensure that
c. The Director of Assays confirmed that the practice is consistent with them.
manufacturer had performed the verification of
performance specifications on the Advia XPT.
.l:)V NOI.LVli\nIO.iNI IIO Ji\IOCTHIDIII 'tlRL 1IHCINO. IDID.SO'I:)Sla W01III .LclWHX'tl NOI.LVli\nIOdNI 'T\II:)1Iffi"i!W0:) 'IVI.LNHCIIIINO:)
PRINTED: 01/25/2016
tOW? STATEMENT OF DEFICIENCIES (X1) PROVIDER/SUPPLIER/CUA (X2) MULTIPLE CONSTRUCTION (X3) DATE SURVEY _
\;@}; AND PLAN OF CORRECTION IDENTIFICATION NUMBER: A. BUILDING _ _ _ _ _ _ __ COMPLETED
0502025714 B. WING _ _ _ _ _ _ _ __
11/20/2015
7333 GATEWAY BLVD
THERANOS INC
NEWARK, CA 94560
TAG
DEFICIENCY)
05421 Conti_nued From page 15 05421
Lab management, including the new
Each laboratory that introduces an unmodified,
lab director, technical supervisors, and 2/12/16
FDA-cleared or approved test system must do the quality systems director, is responsible
following before reporting l)atient test results: for ensuring compliance with these
(1 )(i) Demonstrate tharn can obtain performance procedures. The lab will provide
specifications comparable to those established by oversight through monthly QA
the manufacturer for the following performance meetings, and will monitor ·
characteristics:
(1 )(i){A) Accuracy. compliance through its improved
(1 )(i)(B) Precis~on. . occurrence management and audit
(1 )(i)(C) Reportable range of test results for the procedures.
test system.
(1)(ii) Verify that the manufacturer's reference
intervals (normal values) are appropriate for the
laboratory's patient population.
·.
This STANDARD is not met as evidenced by:
1. Based on review of the performance·
specification verification documentation and
interview with the general supervisor and
technical supervisor, the laboratory failed to
maintain any documentation that the laboratory
had participated in conducting the verification of
the performance specifications on the Advia XPT.
Findings include:
a. The general supervisor and techincal

supervisor stated that the manufacturer
performed all of the performance specification
verification activities on- the Advia XPT.
b. They further stated that the laboratory staff

were available to prepare quality control material
and gathering patient samples for the
manufacturer representative to perform the
verification.
c. The Director of Assays confirmed that the

manufacturer had performed the verification of
performance specifications on the Advia XPT.
.L:JV NOI.LVYrnO.ilNI 110 WOCTHffiliI ffill 1:IHCCNO. ffiIDSO'I:JSia W01III .LcIWHXH NOI.LVYrnO.ilNI 'M:J1:IHWWO:J 'IVI.LNHCIIIINO:J
PRINTED: 01/25/2016
AND PLAN OF CORRECTION IDENTIFICATION NUMBER: A BUILDING _ _ _ _ _ _ __ COMPLETED
0502025714 B. WING _ _ _ _ _ _ _ __
11/20/2015
7333 GATEWAY BLVD
THERANOS INC
NEWARK, CA 94560
TAG
DEFICIENCY)

D5421 #2 2/12/16
2. Based on review of verification procedures,
The lab proactively paused testing on
verification documentation and interivew with the Advia XPT during the survey.
general supervisor and technical supervisor, the The lab has completed an assessment
laboratory failed to verify accuracy, precision, to identify any patients affected or
and/or reportable range for calcium, albumin, having the potential to be affected by
apolipoprotein, triglyceride, carbon dioxide, and this issue.
glucose. In addition, the laboratory failed to verify
the reference interval (normal range) for carbon
dioxide. Findings include: Before the lab resumes any test on the
Advia XPT, the lab will ensure that
a. CL QOP-00022, "Verification of Procedures the test has been re-verified pursuant
Revision A", effective 8/12/14, stated in Section to the lab's improved method
V.B.1.a. in order to determine accuracy "at least verification procedures that have been
20 samples of various reactivity's should be
compared between the method and the old approved by the new lab director.
method ... if a second method is not available These enhanced procedures reinforce
onsite, compare 20 samples tested by a different the required steps and acceptance
method used by a different laboratory." The criteria that must be followed to verify
procdures also stated that the validation plan accuracy, precision, reportable range,
should determine what percentage of accuracy is
acceptable.
and reference intervals before a test is
put into use.
b. CL QOP-00022, "Verification of Procedures
Revision A", effective 8/12/14, stated in Section Before any verification studies are
V.B.1.b. that "a replication experiment" is used to performed, these improved procedures
determine precision. The procedure further require the lab director's review and
stated that "at least 20 samples of various
reactivity's are run 2 or 3 times and results
approval of a detailed method
compared. Duplicate runs may be on different verification plan containing defined
days or by different microbiologists ... " The acceptance criteria. The lab director
procedure also required that the percentage of must also review and approve the
precision for acceptability must be determined. verification report before any patient
testing begins.
c. CL QOP-00022, "Verification of Procedures
Revision A", effective 8/12/14, stated in Section
V. B.1.c. that the reportable range "is the range of The lab has conducted training on
test results from the lowest to the highest that are
reliable and therefore reportable."
CONFIDENTIAL COMMERCIAL INFORMATION EXEMPT FROM DISCLOSURE UNDER 11:IB FREEDOM OF INFORMATION ACT
PRINTED: 01/25/2016
CENTERS FOR MEDICARE & MEDICAID SERVICES OMB NO. 0938-0391
~~il!1; AND PLAN OF CORRECTION IDENTIFICATION NUMBER:

A. BUILDING
COMPLETED
0502025714 B. WING 11/20/2015

7333 GATEWAY BLVD
THERANOS INC
NEWARK, CA 94560
TAG TAG
DEFICIENCY)

these procedures to ensure that
d. CL QOP-00022, "Verification of Procedures
Revision A," effective 8/12/14, stated in Section practice is consistent with them.
V. 8.1.d. required that the validation plan be
approved by the laboratory director "before The laboratory's management,
testing begins." including the new lab director,
technical supervisors, and quality
e. The general supervisor and techincal
supervisor stated that the Advia XPT was put into
systems director, is responsible for
use 12/18/14. ensuring compliance with these
procedures. The lab will provide
Calcium oversight through monthly QA
meetings, and will monitor
i. Standard Operating Procedure (SOP) CL compliance through its improved
SOP-09107, "Calcium (CA, CA_2) in serum,
plasma or urine on the Siemens Advia Chemistry occurrence management and audit
Systems indicated that the reportable range for procedures.
serum and plasma samples was 1.0-16.0 mg/dL.
ii. The manufacturer performed the verification

of performance specifications for serum on
10/23/14. There was no documentation that the
performance specifications had been verified for
plasma samples.
iii. The accuracy study included samples which

ranged from 4.58-15.8 mg/dL.
iv. The accuracy study did not include samples

across the entire reportable range.
v. The accuracy study did not include a

comparison study as required by the laboratory's
procedure.
vi. The accuracy study did not indicate an

acceptable percentage for accuracy.
vii. The precision study included samples which

J.:JV NOI.L'\>'li'nIOtlNI 110 WOCTHffiTII ffill 1IH<INO. tflli1SO'I:JSICT W01III J.clJilJI!XH NOIJ.VW1IOIINI 'IVI:J1!3WWO:J 'IVIJ.NHaIIINO:J
PRINTED: 01/25/2016
fl~!]~) AND PLAN OF CORRECTION IDENTIFICATION NUMBER:
A. BUILDING
COMPLETED
0502025714 B.WING 11/20/2015

7333 GATEWAY BLVD
lHERANOSINC
NEWARK, CA 94560
TAG TAG
DEFICIENCY)

(Continued; see above)
05421
viii. The precision study did not include samples

ix. The precision study only included within run

precision and did not include day-to-day,
run-to-run, or different operators.
x. The summary report from the manufacturer

showed that the reportable range for serum
calcium was 0.5-16.0 mg/dL which differed from
the calcium SOP.
xi. The reportable range data showed included

\ samples from 1.0-13.4 mg/dL which did not cover
the entire reportable range stated in the SOP.
Albumin
i. Standard Operating Procedure (SOP) CL

SOP-09186 Revision A, "Albumin BCP (ALP) in
serum or plasma Advia Chemistry Systems
indicated that the reportable range for serum and
plasma samples was 0.6-8.0 g/dL. The SOP was
effective 7/31/15.

plasma samples.

ranged from 2.0-4.4 g/dL.

PRINTED: 01/25/2016
~[il ;t
AND PLAN OF CORRECTION IDENTIFICATION NUMBER: COMPLETED
A. BUILDING
0502025714 B.WING
11/20/2015
7333 GATEWAY BLVD
THERANOSINC
NEWARK, CA 94560
TAG
DEFICIENCY)

05421
procedure.


ranged from 0.5-5.5 g/dl.

ix. The SOP stated that for precision each

· ..
sample 2 times per run, 2 runs per day, for at
least 20 days.
x. The precision study only included within run

precision and did not include 2 times per run, 2
runs per day, for at least 20 days.
xi. The summary report from the manufacturer

showed that the reportable range for serum
albumin was 0.8-8.0 g/dL which differed from the
SOP.
xii. The reportable range data showed included

samples from 0.4-6.9 g/dL which did not cover
the entire reportable range stated in the SOP.
Apolipoprotein

SOP-09161 Revision A, "Apolipoprotein A-1 in
serum or plasma Chemistry Systems indicated
that the reportable range for serum and plasma
samples was 15-(200-260) mg/dl. The SOP
stated that the reference interval (normal range)
for males was 79-169 mg/dL and females was 76
l::JV NOilVJi'raO.iNI tlO womiffiftl 3HL 1I'iICIN11 ffiI.OSO'I::JSia W01Itl ldWHX'iI NOI.LVW1!0.iNI 'IVI::J1I'i!WWO::J 'IVI.LN'iIGitlNO::J
CONFIDENTIAL COlvlMERCIAL INFORMATION EXEMPT FROM DISCLOSURE UNDER THE FREEDOM OF INFORMATION ACT
PRINTED: 01/25/2016
ffJ STATEMENT OF DEFICIENCIES (X1) PROVIDER/SUPPLIER/CUA (X2) MULTIPLE CONSTRUCTION (X3) DATE SURVEY
\@/ AND PLAN OF CORRECTION IDENTIFICATION NUMBER: A. BUILDING _ _ _ _ _ _ __ COMPLETED
0502025714 8. WING _ _ _ _ _ _ _ __
11/20/2015
7333 GATEWAY BLVD
THERANOS INC
NEWARK, CA 94560
TAG TAG
DEFICIENCY)

-214 mg/dl.

plasma samples.

ranged from 88.6-412.0mg/dl.


procedure.


ranged from 100.9-314.7 mg/dl.


x. The summary report from the manufacturer

showed that the reportable range for serum was
"15- "mg/dl which differed from the SOP.
Triglyceride
i. The manufacturer performed the verification

of performance specifications on 10/23/14. The
.L:JV NOI.LVYrnO.iNI .iIO WOOtIIDI.iI 3H.L cIHClNfl ffiIDSO'l:JSia WOcI.iI .LcIWHXH NOI.LVft\raO.iINI 'lVI::>cIHWWO:J '1VI.LNHCIBNO:J
PRINTED: 01/25/2016
f!)!l:'!l AND PLAN OF CORRECTION IDENTIFICATION NUMBER:
A. BUILDING
COMPLETED
0502025714 B.WING 11/20/2015

7333 GATEWAY BLVD
THERANOSINC
NEWARK, CA 94560
REGULATORY DR LSC IDENTIFYING INFORMATION) CROSS-REFERENCED TO THE APPROPRIATE DATE
TAG TAG
DEFICIENCY)
( Continued; see above)

manufacturer summary report showed that the
reportable range was 0-500 mg/dl. The
manufacturer summary report revealed reference
interval (normal range) was 0-300 mg/dl.
ii. The accuracy study included samples which

ranged from 62.7-259 mg/dl.
iii. The accuracy study did not include samples

iv. The acuracy study did not include a

procedure.
V. The accuracy study did not indicate an

vi. The precision study included samples which

vii. The precision study did not include samples

viii. The precision study only included within run

ix. The reportable range data included samples

from 74.0-447.0 mg/dL which did not cover the
entire reportable range stated in the SOP.
x. The laboratory director did not sign and

approve the verification of performance
specifications. Patient testing began 12/18/14.
Glucose

J.:JV NOIJ.\fli'IBOif.NI !IO WOCTtIH1I!l 3RL 1IHCINn ffiIDSO'T:JSia W01I!l J.c!WBXH NOIJ.VW1!0i£.NI 'TVI:J1£HW:WO:J 'TVIJ.NHGI!INO:J
PRINTED: 01/25/2016
STATEMENT OF DEFICIENCIES (X1} PROVIDER/SUPPLIER/CLIA (X2} MULTIPLE CONSTRUCTION (X3) DATE SURVEY
B. WING _ _ _ _ _ _ _ __
0502025714 11/20/2015
7333 GATEWAY BLVD
·THERANOS INC
NEWARK, CA 94560
TAG TAG
DEFICIENCY)

SOP-09118 Revision A, "Glucose in serum,
plasma, urine or CSF on the Advia Chemistry
Systems" indicated that the reportable range for
serum and plasma samples was 4-700 mg/dL.

plasma samples.



procedure.




x. The reportable range data showed included

samples from 10.6-557.27 mg/dLwhich did not
cover the entire reportable range stated in the
SOP.
.L:JV NOI.LVWHOilNI ilO woamnril ffill 1IHCINfl ffilflSO'I:JSia WOM .LcI:W'iIXH NOI.LVWHOilNI 'TVI:J1It!WWO;J 'TVI.LN:HaiilNO;J
PRINTED: 01/25/2016
STATEMENT OF DEFICIENCIES (X1) PROVIDER/SUPPLIER/CUA {X2) MULTIPLE CONSTRUCTION (X3) DATE SURVEY
,11:~;) AND PLAN OF CORRECTION IDENTIFICATION NUMBER:
A. BUILDING COMPLETED
0502025714 B.WING 11/20/2015

7333 GATEWAY BLVD
THERANOS INC
NEWARK, CA 94560
TAG
DEFICIENCY)

Carbon Dioxide (C02)

SOP-09111 Revision B, "C02 in serum or plasma
on the Advia Chemistry Systems" indicated that
the reportable range for serum or plasma was 10-
40 mEq/L..

plasma samples.
. '·.\
ranged from 12.9-34.3 mEq/L.


procedure.


ranged from 14.3-23.0 mEq/L.


x. The manufacturer summary report indicated

that the verification of the reference interval did
J.::Jv NOI.LVJi'raO.!lNI tlO woamnB HH.L 1IH<INfl ffiIO.SO'K>Sia W01B .LdWHXH NOI.LVJilrn:O.!lNI 'IVI:::rnHWWo:::> 'IVI.LNHCIIlliO:::>
PRINTED: 01/25/2016
iW\ STATEMENT OF DEFICIENCIES (X1) PROVIDER/SUPPLIERICLIA (X2) MULTIPLE CONSTRUCTION (X3) DATE SURVEY
\frji AND PLAN OF CORRECTION IDENTIFICATION NUMBER: A. BUILDING _ _ _ _ _ _ __ COMPLETED
0502025714 B. WING _ _ _ _ _ _ _ __
11/20/2015
7333 GATEWAY BLVD
THERANOSINC
NEWARK, CA 94560
(X4)1D SUMMARY STATEMENT OF DEFICIENCIES ID PROVIDER'S PLAN OF CORRECTION (XS)
TAG TAG
DEFICIENCY)

not pass.
xi. No further documentation verifying the

reference interval was presented to the surveyor.
xii. The laboratory director approved the

verification study on 11/18/14. Patient testing
began on 12/18/14.
05423 493.1253(b)(2) ESTABLISHMENT AND 05423 05423
VERIFICATION OF PERFORMANCE The lab proactively paused testing on
the Advia XPT during the survey. 2/12/16
Each laboratory that modifies an FDA-cleared or The lab has completed an assessment
approved test system, or introduces a test system to identify any patients affected or
not subject to FDA clearance or approval having the potential to be affected by
(including methods developed in-house and
standardized methods such as text book this issue.
procedures), or uses a test system in which
performance specifications are not provided by Before the lab resumes any test on that
the manufacturer must, before reporting patient instrument, the lab will ensure that the
test results, establish for each test system the test has been re-verified pursuant to
performance specifications for the following the lab's improved method
performance characteristics, as applicable:
(2)(i) Accuracy. verification procedures that have been
(2)(ii) Precision. approved by the new lab director.
(2)(iii) Analytical sensitivity. These enhanced procedures reinforce
(2)(iv) Analytical specificity to include interfering the required steps and acceptance
substances. criteria that must be followed to verify
(2)(v) Reportable range of test results for the test accuracy, precision, reportable range,
system.
(2)(vi) Reference intervals (normal values). and reference intervals before a test is
(2)(vii) Any other performance characteristic put into use.
required for test performance.
This STANDARD is not met as evidenced by: Before any verification studies are
Based on review of the alkaline phosphatase performed, these improved procedures
procedure, manufacturer verification report and
interview with the Director of Assays, the
laboratory failed to establish performance
specifications when the laboratory modified the
FORM CMS-2567(02-99) Previous Versions Obsolete Event JD:W34211 Facility ID: CA22046272 If continuation sheet Page 25 of 121
.L:JV NOI.LVJilrnO.!lNI ilO WOOHH&I filJ.I. 1IH<INfl ffilflSO'I:JSia W01Iil .LdWHXH NOI.LVW1IO.!INI 'IVI:J1Iffii\IWO:J 'IVI.LNHaiilNO:J
PRINTED: 01/25/2016
iiflj); STATEMENT OF DEFICIENCIES (X1) PROVIDER/SUPPLIER/CLIA (X2) MULTIPLE CONSTRUCTION (X3) DATE SURVEY
\fad; AND PLAN OF CORRECTION IDENTIFICATION NUMBER: A. BUILDING _ _ _ _ _ _ __ COMPLETED
0502025714 B. WING _ _ _ _ _ _ _ __
11/20/2015
7333 GATEWAY BLVD
THERANOS INC
NEWARK, CA 94560
TAG TAG
DEFICIENCY)
D5423 (continued)
require the lab director's review and
reportable range for alkaline phosphatase.
Findings include: approval of a detailed method
verification plan containing defined
a. Standard Operating Procedure (SOP) CL acceptance criteria. The lab director
SOP-09102 Revision B, "Alkaline Phosphatase must also review and approve the
(ALP) in serum or plasma on the Advia Chemistry verification report before any patient
Systems" indicated that the reportable range for testing begins.
serum and plasma samples was 0-1100 IU/L.
b. The Director of Assays stated that the The lab has conducted training on
reportable range was 10-1100 IU/L and that the these procedures to ensure that
SOP was incorrect. practice is consistent with them.
c. The manufacturer performed the verification
The lab's management, including the
..
10/23/14. There was no documentation that the new lab director, technical
performance specifications had been verified for supervisors, and quality systems
plasma samples. director, is responsible for ensuring
compliance with these procedures.
d. The accuracy study included samples which The lab will provide oversight through
ranged from 23.70-423.0 IU/L.
e. The accuracy study did not include samples monitor compliance through_its
across the entire reportable range. improved occurrence management and
audit procedures.
f. The accuracy study did not include a
procedure.
g. The accuracy study did not indicate an

h. The precision study included samples which

ranged from 30.9-359.0 IU/L.
i. The precision study did not include samples

j. The precision study included within run

FORM CMS-2567(02-99) Previous Versions Obsolete Event ID:W34211 Facility ID: CA22D46272 If continuation sheet Page 26 of 121
J::JV NOI.LVJi\IB:O.iNI i:IO woamnri:13H.L 1[3(Ili[(l 3:llilSO'I;)SIQ :W01[i:l .LclJi'tHX3 NOI.LVJi'ffiO.iNI 'IVI:)1[3Ji\!WQ;) 'IVI.LN30Ii:IN0;)
PRINTED: 01/25/2016
i\t
iuui > STATEMENT OF DEFICIENCIES
(X1) PROVIDER/SUPPLIER/CLIA
A. BUILDING _ _ _ _ _ _ __
(X3) DATE SURVEY
COMPLETED
0502025714 B.WING
11/20/2015
7333 GATEWAY BLVD
THERANOSINC
NEWARK, CA 94560
TAG TAG
DEFICIENCY)

precision, but did not include day-to-day,
k. The summary report from the manufacturer

showed that the reportable range for serum ALP
was 0-1100 IU/L.
I. The reportable range data showed included

samples from 12-914 IU/L which did not cover the
entire reportable range.
m. The Director of Assays stated that analytic

sensitivity and analytic specifictity was not
established for the modified ALP assay.
05429 493.1254(a)(1) MAINTENANCE AND FUNCTION 05429 D5429
CHECKS The lab has completed an assessment 2/12/16
220M to identify any patients affected or
For unmodified manufacturer's equipment, having the potential to be affected by
instruments, or test systems, the laboratory must this issue. Following the survey,
perform and document maintenance as defined weekly maintenance on the Evolis has
by the manufacturer and with at least the been performed. The new lab director
frequency specified by the manufacturer.
This STANDARD is not met as evidenced by: has approved enhanced proc~dures
Based on technical supervisor interviews and addressing equipment maintenance,
Evolis maintenance log record review on which reinforce the lab's systems for
November 17, 2015, the laboratory failed to performing and documenting all
perform weekly Evolis maintenance as defined by required maintenance. The lab has
the manufacturer. Findings included:
a. In general immunology, it was the practice of procedures to ensure that practice is
the laboratory to test patient ANA, HIV Ag/Ab, and consistent with them.
quantiferon using the Bio-Rad Evolis system.
Lab management, including new lab
b. In August 2015, for 2 (weeks 1 and 3) of 4 director, technical supervisors, and
weeks in which patient specimens were tested,
the laboratory maintained no documentation to
indicate that weekly manufacturer required ensuring that these procedures are
maintenance had been performed.
J.:JV NOIJ.VYrnOdNI i[Q wornrillH ffill <IHCINO ffiillSO'I:JSia WOTul J.cIWHXH NOIJ.VW<IO!lNI 'IVI:J<IBJi'lWO:J 'IVIJ.NHaiilNO:J
PRINTED: 01/25/2016
{@{) STATEMENT OF DEFICIENCIES (X1) PROVIDER/SUPPLIER/CUA (X2) MULTIPLE CONSTRUCTION (X3) DATE SURVEY
\@'] AND PLAN OF CORRECTION IDENTIFICATION NUMBER: A. BUILDING _ _ _ _ _ _ __ COMPLETED
0502025714 B. WING _ _ _ _ _ _ _ __
11/20/2015
7333 GATEWAY BLVD
THERANOSINC
NEWARK, CA 94560
TAG TAG
DEFICIENCY)
D5429 (continued)
followed. The lab will provide
c. In August 2015, the laboratory performed and
oversight of required maintenance
reported 844 patient HIV Ag/Ab test results using through monthly QA meetings, and
the Evolis system. will monitor compliance through its
05437 493.1255(a) CALIBRATION AND CALIBRATION 05437 improved occurrence management and
VERIFICATION audit procedures.
400M
Unless otherwise specified in this subpart, for
each applicable test system the laboratory must
perform and document calibration procedures--
(1) Following the manufacturer's test system
instructions, using calibration materials provided
or specified, and with at least the frequency
recommended by the manufacturer;
(2) Using the criteria verified or established by the
laboratory as specified in §493.1253(b)(3)--
(2)(i) Using calibration materials appropriate for
the test system and, if possible, traceable to a
reference method or reference material of known
value; and
(2)(ii) Including the number, type, and
concentration of calibration materials, as well as
acceptable limits for and the frequency of
calibration; and
(3) Whenever calibration verification fails to meet
the laboratory's acceptable limits for calibration
verification.
This STANDARD is not met as evidenced by: (D5437#1 begins on next page)
complete blood counts (CBC) calibration
documentation record reviews on September 23,
2015, the laboratory failed to document all CBC
instrument calibrations performed using the Drew
3 instruments. Findings included:
.L:J\f NOI.LVW1IO.!INI tlO WOOH'.31Itl HH.L 1IHCCNO. '.31IOSO'I:)Sia WOTu:I .LdW'iIXH NOI.LVJi'ffiO.!INI 'IVI::rnHW:wo::> 'IVI.LNHaitlNO:J
PRINTED: 01/25/2016
,ff:
QfaW
\ STATEMENT OF DEFICIENCIES
A. BUILDING _ _ _ _ _ _ __
(X3) DATE SURVEY
COMPLETED
0502025714 8. WING _ _ _ _ _ _ _ __
11/20/2015
7333 GATEWAY BLVD
THERANOSINC
NEWARK, CA 94560
TAG TAG
DEFICIENCY)
c. In August 2015, the laboratory performed and

reported 844 patient HIV Ag/Ab test results using
the Evolis system.
05437 493.1255(a) CALIBRATION AND CALIBRATION 05437 D5437 #1
VERIFICATION The lab has completed an assessment 2/12/16
400M to identify any patients affected or
Unless otherwise specified in this subpart, for
each applicable test system the laboratory must
having the potential to be affected by
perform and document calibration procedures-- this issue.
(1) Following the manufacturer's test system
instructions, using calibration materials provided The new lab director has approved
or specified, and with at least the frequency enhanced procedures addressing
recommended by the manufacturer; equipment systems, reinforcing that
(2) Using the criteria verified or established by the
laboratory as specified in §493.1253(b)(3)-- calibration documentation must be
(2)(i) Using calibration materials appropriate for organized and maintained. The lab has
the test system and, if possible, traceable to a conducted training on those
reference method or reference material of known procedures to ensure that practice and
value; and documentation is consistent with
(2)(ii) Including the number, type, and them. Assay-specific SOPs will
concentration of calibration materials, as well as
acceptable limits for and the frequency of identify the specific procedures used
calibration; and for each platform or instrument.
(3) Whenever calibration verification fails to meet
the laboratory's acceptable limits for calibration Lab management, including new lab
verification. director, technical supervisors, and
This STANDARD is not met as evidenced by: ensuring that these procedures are
1. Based on laboratory personnel interviews and followed. The lab will provide
documentation record reviews on September 23,
2015, the laboratory failed to document all CBC
instrument calibrations performed using the Drew
3 instruments. Findings included:
PRINTED: 01/25/2016
STATEMENT OF DEFICIENCIES (X1) PROVIDERISUPPLIERICLIA (X2) MULTIPLE CONSTRUCTION (X3) DATE SURVEY
0502025714 B. WING _ _ _ _ _ _ _ __
11/20/2015
7333 GATEWAY BLVD
THERANOS INC
NEWARK, CA 94560
DEFICIENCY)
patient capillary CBC specimens using two Drew
o5437 oversight through monthly QA
3 instruments the laboratory designated as "Drew
#2" and "Drew #3." On September 23, 2015, compliance through its improved
information recorded on "Drew #2" indicated that occurrence management, and audit
the "Drew #2" was calibrated on August 24, 2015, procedures.
and information recorded on "Drew #3" indicated
that the "Drew #3" was calibrated on August 31,
2015.
b. The laboratory maintained no documentation

of the August 24, 2015 and August 31, 2015
calibrations of the laboratory's two Drew 3 CBC
instruments.
c. According to laboratory personnel, between

August 24, 2015 and September 23, 2015, the
laboratory performed and reported 864 patient
CBC specimens using the two Drew 3
instruments.
D5437 #2
The laboratory proactively paused 2/12/16
documentation record reviews on November 19, testing on the Advia 2120i dµring the
2015, the laboratory failed to document all CBC survey. The lab has completed an
instrument calibrations performed using a Advia assessment to identify any patients
2120i instrument. Findings included: affected or having the potential to be
affected by this issue.
patient venous CBC specimens using two
Siemens Advia 2120i instruments, designated as The new lab director has approved
#1 and #2. enhanced procedures addressing
equipment systems, reinforcing that
b. For Advia 2120i #1, the laboratory maintained calibration documentation must be
no documentation of any calibrations prior to organized and maintained. The lab has
September 21, 2015. For Advia 2120! #2, the
laboratory maintained no documentation of any
calibrations performed. procedures.

FORM CMS-2567(02-99) Previous Versions Obsolete Event ID:W34211 Fac:lllty ID: CA22046272 If continuation sheet Page 29 of 121
(,
I
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PRINTED: 01/25/2016
tf@\. STATEMENT OF DEFICIENCIES (X1) PROVIDER/SUPPLIER/CUA (X2) MULTIPLE CONSTRUCTION (X3) DATE SURVEY
\(@}/ AND PLAN OF CORRECTION IDENTIFICATION NUMBER: A. BUILDING _ _ _ _ _ _ __ COMPLETED
0502025714 B.WING 11/20/2015

7333 GATEWAY BLVD
THERANOSINC
NEWARK, CA 94560
TAG
DEFICIENCY)
The new lab director has also
2,395 patient CBC test results using the Advia approved specific calibration
2120i #1. From November 6, 2015 to November procedures for CBC on the Advia
19, 2015, the laboratory performed and reported 2120i. Before the lab resumes any
67 patient CBC test results using the Advia 21201 tests on the Advia 2120i, it will
#2. conduct training on those procedures.
05447 493.1256(d)(3)(i)(g) CONTROL PROCEDURES 05447 In addition, testing personnel will be
required to demonstrate competency
400H Unless CMS Approves a procedure, specified in
Appendix C of the State Operations Manual to ensure that practice is consistent
(CMS Pub. 7), that provides equivalent quality with those procedures.
testing, the laboratory must--
Lab management, including the new
At least once a day patient specimens are lab director, technical supervisors, and
assayed or examined perform the following for--
Each quantitative procedure, include two control ensuring that these procedures are
materials of different concentrations; followed. The lab will provide
oversight through monthly QA
(g) The laboratory must document all control meetings, and will monitor
procedures performed. compliance through its improved
Based on laboratory personnel interviews and occurrence management and. audit
WBC differential quality control record review on procedures.
November 19, 2015, the laboratory failed to
include two quality control materials with differing
WBC differential patterns at least once each day
patient WBC differential specimens were
examined using the Cellavision instrument.
Findings included:
a. It was the practice of the laboratory to use the

Cellavision instrument to aid in the examination
and reporting of patient WBC differentials
performed from stained slides.
b. According to laboratory personnel, although

the laboratory performed a function check (cell
l.:JV NOU.~O.ilNI i[Q woamrad 3H.L 1]HCINf1 811DSO'I:::>Sia W01Ii! J.d:WHXH NOU.VJilraO.ilNI 'TVI:::>1!8:WWO:::> 'TVIJ.Na:aiilNO:::>
PRINTED: 01/25/2016
p;{'.}; STATEMENT OF DEFICIENCIES (X1) PROVIDER/SUPPLIER/CUA (X2) MULTIPLE CONSTRUCTION (X3) DATE SURVEY
%]UY AND PLAN OF CORRECTION IDENTIFICATION NUMBER: A. BUILDING _ _ _ _ _ _ __ COMPLETED
0502025714 B. WING _ _ _ _ _ _ _ __
11/20/2015
7333 GATEWAY BLVD
THERANOS INC
NEWARK, CA 94560
TAG TAG
DEFICIENCY)

2120i#1. From November 6, 2015to November
19, 2015, the laboratory performed and reported
67 patient CBC test results using the Advia 21201
#2.
05447 493.1256(d){3)(i)(g) CONTROL PROCEDURES 05447 05447
Appendix C of the State Operations Manual the Cellavision during the survey.
(CMS Pub. 7), that provides equivalent quality The lab has completed an assessment
testing, the laboratory must-- to identify any patients affected or
At least once a day patient specimens are this issue.
assayed or examined perform the following for--
Each quantitative procedure, include two control The new lab director has approved
materials of different concentrations; enhanced QC procedures that
reinforce the need to perform QC with
(g) The laboratory must document all control at least two levels of control, unless
procedures performed. otherwise specified, and the lab has
Based on laboratory personnel interviews and conducted training on those .
WBC differential quality control record review on procedures.
November 19, 2015, the laboratory failed to
include two quality control materials with differing The new lab director has also
WBC differential patterns at least once each day approved enhanced procedures for the
patient WBC differential specimens were
Cellavision instrument to reinforce
examined using the Cellavision instrument.
Findings included: that the daily WBC differential must
include two QC materials with
a. It was the practice of the laboratory to use the differing WBC patterns. Before the
Cellavision instrument to aid in the examination lab resumes any tests on the
and reporting of patient WBC differentials Cellavision, it will conduct training
performed from stained slides.
and competency testing on those
b. According to laboratory personnel, although procedures to ensure that practice is
the laboratory performed a function check (cell consistent with them.
.L:JV NOI.LVJ!'raO!lNI !IO womI'illIII 'iIHL 1IHCINO. 3}l{1.S0'1:JSIQ W01Id .LcIW:HX'il NOI.LVWRO!INI 'IVI:J1!3]i'{W0:J 'IVI.LN'ilaitlNO:J
CONFIDENTIAL COMMERCIAL INFORMATION EXEMPT FROM DISCLOSURE UNDER TIIB FREEDOM OF INFORMATION ACT
PRINTED: 01/25/2016
(111:I: AND PLAN OF CORRECTION IDENTIFICATION NUMBER: A. BUILDING
COMPLETED
0502025714 B.WING 11/20/2015

7333 GATEWAY BLVD
THERANOSINC
NEWARK, CA 94560
TAG TAG
DEFICIENCY)
D5447 (continued)
Lab management, including technical
locator) each day the Cellavision was used to
examine patient stained slides, the laboratory did
supervisors, will be responsible for
not examine two quality control materials with ensuring that these procedures are
differing WBC differential patterns each day the followed. The lab will provide
Cellavision was used to examine patient stained oversight through monthly QA
slides. Laboratory personnel also stated that all meetings, and will monitor
Cellavision examinations were reviewed by compliance through its improved
testing personnel and revised, if necessary,
before the examination was release for reporting. occurrence management, and audit
However, the Cellavision did perform the primary procedures.
WBC differential screening of patient stained
slides.
c. According to laboratory personnel, since

February 2015, the laboratory examined and
reported 225 patient WBC differentials using the
Cellavision.
05449 493.1256(d)(3)(ii)(g) CONTROL PROCEDURES 05449 D5449
Prior to the survey, the lab followed 2/12/16
110H Unless CMS Approves a procedure, specified in the procedures for QC identified in the
220H Appendix C of the State Operations Manual manufacturer's package insert for this
(CMS Pub. 7), that provides equivalent quality
testing, the laboratory must-- FDA cleared device.
At least once a day patient specimens are The lab has completed an assessment
assayed or examined perform the following for-- to identify any patients affected or
Each qualitative procedure, include a negative this issue.
and positive control material;
(g) The laboratory must document all control The new lab director has approved
procedures performed. enhanced QC procedures that
This STANDARD is not met as evidenced by: reinforce the need to perform QC with
Based on technical supervisor interview and at least two levels of control, unless
CT/NG quality control record review on
otherwise specified, and the lab has
November 17, 2015, at least once a day patient
specimens were assayed, the laboratory failed to conducted training on those
include a positive CT/NG quality control material. procedures.
l::JV NOil.VV'ffiOdNC ilO Ji'i!OOHmiil HHl. 1IH<INI1 lnl.O.SO'I::JSia W01III l.cil'\!HXH NOil.VW1IOdNC 'IVI:::>1IHWWO:::> 'IVIl.NHCIHNO:::>
CONFIDENTIAL COMMERCIAL INFORMATION EXE1\.1PT FROM DISCLOSURE UNDER THE FREEDOM OF INFORMATION ACT
PRINTED: 01/25/2016
trnu
\jjij'
A. BUILDING _ _ _ _ _ _ __
(X3) DATE SURVEY
COMPLETED
0502025714 B. WING _ _ _ _ _ _ _ __
11/20/2015
7333 GATEWAY BLVD
THERANOSINC
NEWARK, CA 94560
TAG TAG
DEFICIENCY)
05449 Continued From page 31 05449 ~~::~c~=i~;:~for has also

Findings included:
approved enhanced procedures for
a. It was the practice of the laboratory to CT/NG to require the use of a positive
perform and report patient CT/NG testing using a CT/NG control material that is not
PCR method. also used as a calibrator.
b. Laboratory records indicated that on Lab management, including technical
November 13, 2015 the laboratory performed
patient CT/NG testing without including a positive supervisors, will be responsible for
CT/NG quality control material in the assay. ensuring that these procedures are
Although the laboratory included samples the followed. The lab will provide
manufacturer labeled as a "positive" CT/NG oversight through monthly QA
quality control material in the assay, the test meetings, and will monitor
results of this "positive" CT/NG quality control
material were used to calculate the assay cutoff
which determines whether patient test results occurrence management and audit
tested as positive or negative for CT/NG. As a procedures.
result, the manufacturer's "positive" CT/NG
quality control material was considered a
calibrator and not quality control material. The
laboratory assayed no other positive CT/NG
quality control materials.
c. On November 13, 2015, the laboratory tested

41 patient CT/NG specimens.
d. Pursuant to 42 C.F.R. 493.1256(d)(9), when

using calibration material as control material, the
laboratory must at least use calibration material
from a different lot than that used to establish a
cut-off value.
05469 493.1256(d)(1 O)(g) CONTROL PROCEDURES 05469 (D5469 #1 begins on next page)
2/12/16
Appendix C of the State Operations Manual
(CMS Pub. 7), that provides equivalent quality
testing, the laboratory must--
PRINTED: 01/25/2016
tff:) STATEMENT OF DEFICIENCIES (X1) PROVIDER/SUPPLIER/CUA (X2) MULTIPLE CONSTRUCTION (X3) DATE SURVEY
%1:Y AND PLAN OF CORRECTION IDENTIFICATION NUMBER: A. BUILDING _ _ _ _ _ _ __ COMPLETED
B. WING _ _ _ _ _ _ _ __
0502025714 11/20/2015
7333 GATEWAY BLVD
T.HERANOSINC
NEWARK, CA 94560
TAG
DEFICIENCY)
D5469 #1
The lab has completed an assessment
Establish or verify the criteria for acceptability of
all control materials.
to identify any patients affected or
(i) When control materials providing quantitative this issue.
results are used, statistical parameters (for
example, mean and standard deviation) for each The new lab director has approved
batch and lot number of control materials must be enhanced procedures to reinforce the
defined and available.
(ii) The laboratory may use the stated value of a practice of parallel testing each new
commercially assayed control material provided lot of control material with the lot of
the stated value is for the methodology and control material in use, and
instrumentation employed by the laboratory and is establishing a range based on the
verified by the laboratory. manufacturer's range. The lab has
(iii) Statistical parameters for unassayed control
materials must be established over time by the
laboratory through concurrent testing of control procedures.
materials having previously determined statistical
parameters. Lab management, including technical
supervisors and the quality director,
(g) The laboratory must document all control will be responsible for ensuring that
procedures performed.
these procedures are followed. The
1. Based on laboratory personnel interviews and lab will provide oversight through
complete blood counts (CBC) quality control monthly QA meetings, and will
record review on September 23, 2015, the monitor compliance through its
laboratory failed to verify the stated values of the improved occurrence management and
commercially assayed CBC quality control audit procedures.
materials in use at the time of the survey.
Findings included:
a. It was the practice of the laboratory to use

commercially assayed CBC quality control
materials to monitor patient CBC testing using
two Drew 3 instruments ..
b. Laboratory CBC quality control records

indicated that on June 27, 2015 the laboratory
changed the lot of quality control material from lot
number EX045 to EX075.
PRINTED: 01/25/2016
t:fff), STATEMENT OF DEFICIENCIES (X1) PROVIDER/SUPPLIER/CLIA (X2) MULTIPLE CONSTRUCTION (X3) DATE SURVEY
ii]@)' AND PLAN OF CORRECTION IDENTIFICATION NUMBER: A. BUILDING _ _ _ _ _ _ __ COMPLETED
0502025714 B. WING _ _ _ _ _ _ _ __
11/20/2015
7333 GATEWAY BLVD
T.HERANOSINC
NEWARK, CA 94560
DEFICIENCY)
c. The laboratory maintained no documentation

to indicate that the stated values of CBC quality
control material lot number EX075 had been
verified by the laboratory.
d. According to laboratory personnel, between

June 27, 2015 and September 24, 2015, the
laboratory used one of the Drew 3 instruments on
30 different days to perform and report patient
CBC specimens, and used the other Drew 3
instrument on 87 different days to perform and
report patient CBC specimens.
2. Based on interview with the general

D5469 #2
supervisor and chemistry quality control (QC) The lab has completed assessments to 2/12/16
records on November 17, 2015, the laboratory identify any patients affected or
failed to verify the stated values of the having the potential to be affected by
commercially assayed QC material. Findings this issue.
include:
a. The general supervior stated that when a new

lot number of QC was started, the QC ranges enhanced procedures to reinforce the
were entered into the chemistry analyzers (Advia practice of parallel testing ea:ch new
1800 and Advia XPT) from the manufacturer's lot of control material with the lot of
package insert just prior to use. control material in use, and
establishing a range based on the
b. The general supervisor further stated that the
new lot number of QC was run one time prior to
manufacturer's range. The lab has
patient testing. conducted training on those
procedures.
c. QC records show that MultiQual lot number
45660 was put into use in 2014 and discontinued Lab management, including technical
in August 2015.
supervisors and quality systems
d. The general supervisor and Director of
director, will be responsible for
Assays confirmed on 11/17/15 at 9:40 am that ensuring that these procedures are
manufacturer's QC ranges for new lot numbers of followed. The lab will provide
chemistry controls were not verified.
.I.:::>V NOI.I.VJi'IBO.!lNJ: tlO WOCTH1nlil ffill 1£HCIN[l ffiIDSO'I:::>Sia W01ltl .I.d:WIIXH NOI.I.VWHO.!INJ: 'IVI:)1[ffii\!Jfi[Q:) 'IVI.I.NHOitlNO:::>
PRINTED: 01/25/2016
Af@!\ STATEMENT OF DEFICIENCIES (X1) PROVIDER/SUPPLIER/CLIA (X2) MULTIPLE CONSTRUCTION (X3) DATE SURVEY
l(f{)' AND PLAN OF CORRECTION IDENTIFICATION NUMBER: A. BUILDING _ _ _ _ _ _ __ COMPLETED
0502025714 B. WING _ _ _ _ _ _ _ __
11/20/2015
7333 GATEWAY BLVD
T.HERANOSINC
NEWARK, CA 94560
TAG TAG
DEFICIENCY)
oversight through monthly QA
to indicate that the stated values of CBC quality compliance through its improved
control material lot number EX075 had been occurrence management and audit
verified by the laboratory. procedures.
d. According to laboratory personnel, between
June 27, 2015 and September 24, 2015, the
laboratory used one of the Drew 3 instruments on
30 different days to perform and report patient
CBC specimens, and used the other Drew 3
instrument on 87 different days to perform and
report patient CBC specimens.
2. Based on interview with the general

supervisor and chemistry quality control (QC)
records on November 17, 2015, the laboratory
failed to verify the stated values of the
commercially assayed QC material. Findings
include:
a. The general supervior stated that when a new

lot number of QC was started, the QC ranges
were entered into the chemistry analyzers (Advia
1800 and Advia XPT} from the manufacturer's
package insert just prior to use.
b. The general supervisor further stated that the

new lot number of QC was run one time prior to
patient testing.
c. QC records show that MultiQual lot number

45660 was put into use in 2014 and discontinued
in August 2015.
d. The general supervisor and Director of

Assays confirmed on 11/17/15 at 9:40 am that
manufacturer's QC ranges for new lot numbers of
chemistry controls were not verified.
(.
.L:JV NOI.L"\IJ'rnO.iNI a:o woamraa: 8RL 113:CINfl ffiIDSO'I:JSia W01Itl .LcIWHXH NOI.LVJi'raOdNI 'IVI:::>113:WWO:J 'IVI.LNHOitlNO:J
PRINTED: 01/25/2016
&F>. STATEMENT OF DEFICIENCIES (X1) PROVIDER/SUPPLIER/CUA (X2) MULTIPLE CONSTRUCTION (X3) DATE SURVEY
\&) AND PLAN OF CORRECTION IDENTIFICATION NUMBER: A. BUILDING _ _ _ _ _ _ __ COMPLETED
B. WING _ _ _ _ _ _ _ __
0502025714 11/20/2015
7333 GATEWAY BLVD
T.HERANOS INC
NEWARK, CA 94560
TAG
DEFICIENCY)
05477 493.1256(e)(4)(g) CONTROL PROCEDURES 05477

05477 2/12/16
110H (e) For reagent, media, and supply checks, the The lab has completed an assessment
laboratory must do the following: to identify any patients affected or
(e)(4) Before, or concurrent with the initial use-- this issue.
(e)(4)(i) Check each batch of media for sterility if
sterility is required for testing;
(e)(4)(ii) Check each batch of media for its ability The new lab director has approved
to support growth and, as appropriate, select or enhanced QC procedures for
inhibit specific organisms or produce a microbiology.
biochemical response; and
(e)(4)(iii) Document the physical characteristics of Lab management, including technical
the media when compromised and report any
supervisors, will be responsible for
deterioration in the media to the manufacturer.
ensuring that these procedures are
(g) The laboratory must document all control followed. The lab will provide
procedures performed. oversight through monthly QA
This STANDARD is not met as evidenced by: meetings, and will monitor
Based on technical supervisor interview and compliance through its improved
bacteriology media quality control record review
on November 18, 2015, the laboratory failed to occurrence management and audit
check each batch of media for its ability to procedures.
support growth before or concurrent with initial
use. Findings included:
a. From November 15, 2015 to November 18,

2015, the laboratory performed patient
bacteriology testing using Hardy blood agar
plates (BAP), lot number 15300, expiration date
01/25/2016.
b. For this lot of BAP, the laboratory relied on

manufacturer's documentation that the
manufacturer performed quality control
procedures on the BAP. The laboratory did not,
before or concurrent with initial use, performed
any quality control procedures to check whether
this lot of BAP supported organism growth.
FORM CMS-2567(02-99) Previous Versions Obsolete Event ID:W34211 Facillty ID: CA22046272 If continuation sheet Page 35 of 121
J.:JV NOIJ.YmO!lNI tlO WOOtI81li:I ffill 1ItI<INfl ffilflSO'I:JSIQ W01Itl J.cIWHX'iI NOIJ.Vli'ffiO!lNI 1VI:J1Iffii'ffi!O:J 1VIJ.NHGHNO:J
PRINTED: 01/25/2016
tW\, STATEMENT OF DEFICIENCIES (X1) PROVIDER/SUPPLIER/CUA (X2) MULTIPLE CONSTRUCTION (X3) DATE SURVEY
\j@j) AND PLAN OF CORRECTION IDENTIFICATION NUMBER: A BUILDING _ _ _ _ _ _ __ COMPLETED
0502025714 B. WING _ _ _ _ _ _ _ __
11/20/2015
7333 GATEWAY BLVD
THERANOSINC
NEWARK, CA 94560
TAG
DEFICIENCY)

c. From November 15, 2015 to November 18,
2015, the laboratory performed 12 patient
specimen cultures using Hardy BAP, lot number
15300, expiration date 01/25/2016.
05481 493.1256(f)(g) CONTROL PROCEDURES 05481 D5481 #1
The laboratory paused testing on the 2/12/16
(f) Results of control materials must meet the Siemens BCS XP, including PT/INR,
laboratory's and, as applicable, the
manufacturer's test system criteria for
during the survey. The lab has
acceptability before reporting patient test results. completed an assessment to identify
any patients affected or having the
(g) The laboratory must document all control potential to be affected by this issue.
procedures performed.
This STANDARD is not met as evidenced by; The new lab director has approved
1. Based on review of the prothrombin
· .. time/international normalized ratio (PT/INR)
enhanced QC procedures, which
procedure, quality control (QC) records, patient reinforce and detail the required
results and interview with the general supervisor, investigation and corrective action that
the laboratory failed to ensure that the QC for must occur to address QC issues
PT/INR was acceptable prior to reporting patient before patient tests are performed and
results from April 2015 through September 2015. clarify which employees are
Findings include:
responsible for performing and
a. CL SOP-10001 Revision A, "Measuring documenting these activities: The lab
Prothrombin Time-lnnovin (PT on the Siemens has conducted training and
BCS XP Instrument" stated on page 6, section competency on those procedures to
8.6 that if control values are outside of the ensure that practice is consistent with
determined range, the controls, reagents and
them.
instrument performance should be checked and
that identification and correction of the problem
shoud be documented prior to reporting patient Lab management, including technical
results. supervisors and the quality systems
director, is responsible for ensuring
b. QC records for Citro! 3 (Lot number 548425) compliance with these procedures.
were reviewed from 4/1/15 through 9/23/15.
The lab will also provide oversight
c. The general supervisor stated that QC was
acceptable If the values were +/- 2 SD from the
FORM CMS-2567(02-99) Previous Versions Obsolete Event ID; W34211 Faclllty ID: CA22046272 If continuation sheet Page 36 of 121
l:JV NOilYmO.iNI iIO woamrna: 3Hl clHCINfl ffiIO.SO'I:JSia WOcld: ldWHXH NOI.LVMIOa:NI 'IVI::nIHWWO::> 'IVIlNHaI.!INO:J
CONFIDENTIAL COMMERCIAL INFORMATION EXEMPT FROM DISCLOSURE UNDER Tim FREEDOM OF INFORMATION ACT
PRINTED: 01/25/2016
STATEMENT OF DEFICIENCIES (X1} PROVIDER/SUPPLIER/CUA (X2} MULTIPLE CONSTRUCTION (X3) DATE SURVEY
fil;llllt AND PLAN OF CORRECTION IDENTIFICATION NUMBER: A. BUILDING _ _ _ _ _ _ __ COMPLETED
0502025714 B.WING 11/20/2015

7333 GATEWAY BLVD
THERANOSINC
NEWARK, CA 94560
(X4}1D SUMMARY STATEMENT OF DEFICIENCIES ID PROVIDER'S PLAN OF CORRECTION (XS)
TAG
DEFICIENCY)
through monthly QA meetings, and
mean.
will monitor compliance through its
d. On 9/7/15, Citrol 3 was run seven times improved occurrence management and
without obtaining an acceptable QC value. audit procedures.
e. On 9/8/15, Citro! 3 was run twelve times

without obtaining an acceptable QC value.
f. On 25 of 32 days, Citro! 3 was not rerun

when the QC value was greater than - 2 SD.
g. On 5/15/15, 8/13/15, 8/21/15 and 9/10/15,

Citro! 3 was run twice. All QC results were
unacceptable.
',,
h. The Rule Check report revealed that 13 of 13
QC values in April 2015, 2 of 17 in May 2015, 7 of
7 in June 2015, 13 of 13 in July 2015, 16 of 16 in
August, and 24 of 24 during September 1-16,
2015 showed rule violation messages related to
Citrol 3.
i. 81 patients were reported from 4/1/15

through 9/16/15.
D5481 #2
2. Based on review of the quality control (QC) The lab has completed an assessment 2/12/16
procedure, QC records, and raw data from to identify any patients affected or
patient test runs and interview with the general
supervisor, the laboratory failed to ensure that the
QC was acceptable for the Theranos Proprietary this issue.
System (TPS) prior to reporting patient test
results: Findings include: The new lab director has approved
a. CL SOP-15026 Revision A, "Edison 3.5 reinforce that QC results must be
Theranos System Daily QC Procedures", stated
the following in section 10.1.1: " ... For any single
acceptable before patient tests are
Edison instrument, reject QC if either level is performed, and detail the steps to take
greater than 2 SD or if either level falls on the
same side of the mean for 10 consecutive days."
J.::>V NOIJ.\ilirnO!lNI .!IO womrmi:a ffill 1IHCINC1 ffiIQSO'I::>Sia W01!.!I J.cIWHXH NOIJ.Vli'ffiOdNI 'IVI::>1IHWWO::> 'IVIJ.NHGI.!INO::>
PRINTED: 01/25/2016
(fi}: STATEMENT OF DEFICIENCIES (X1) PROVIDER/SUPPLIER/CUA (X2) MULTIPLE CONSTRUCTION {X3) DATE SURVEY
%@ ) AND PLAN OF CORRECTION IDENTIFICATION NUMBER: A. BUILDING _ _ _ _ _ _ __ COMPLETED
0502025714 B. WING _ _ _ _ _ _ _ __
11/20(2015
7333 GATEWAY BLVD
THERANOS INC
NEWARK, CA 94560
TAG
DEFICIENCY)
when QC results are not acceptable.
b. Section 11.1.1 of CL SOP-15026 Revision A
The lab has conducted training and
further stated that "Daily QC automatically competency on those procedures to
expires 24 hours after use." ensure that practice is consistent with
them.
c. The general supervisor stated that when the
QC was unacceptable, the TPS device locked out
Lab management, including technical
patient testing for 24 hours or until the QC was
acceptable and if the QC was unacceptable supervisors and the quality systems
another device would be used for testing. director, is responsible for ensuring
that these procedures are followed.
d. QC records for Sex Hormone Binding The lab will also provide oversight
Globulin (SHBG) showed that on Device E001025 through monthly QA meetings, and
QC Level 2's (QC2) 24 hour expiration was on
will monitor compliance through its
8/14/14 at 18:54 and was not run again until
8/15/14 at 00:05. Patient data showed that improved occurrence management and
patient Accession #94389 was run on 8/14/14 at audit procedures.
19:09.
e. QC records for SHBG showed that on Device

E001025 QC Level 1's (QC1) 24 hour expiration
was on 8/20/14 at 17:43 and was not run again
until 8/21/14 at 17:50. Patient data showed that
patient Accession #95403 was run on 8/20/14 at
19:08.
f. QC records for SHBG showed that on Device

E001036 QC1 was not run again until 11/1/14 at
22: 15. Patient data showed that patient
Accession #112807 was run on 11/1/14 at 00:02.
g. QC records for Vitamin 812 (VB12) showed

that on Device E000027 QC1 was run on 8/16/14
at 06:16 and failed. QC1 was next run 8/17/14 at
09: 10 and passed. QC2 was not run on 8/15/14
or 8/16/14. Patient data showed that patient
Accession #94598 was run on 8/16/14 at 00:48.
h. QC records for VB12 showed that on Device

PRINTED: 01/25/2016
tfF> STATEMENT OF DEFICIENCIES (X1) PROVIDER/SUPPLIER/CLIA (X2) MULTIPLE CONSTRUCTION (X3) DATE SURVEY
COMPLETED
\{fa}i AND PLAN OF CORRECTION IDENTIFICATION NUMBER: A. BUILDING _ _ _ _ _ _ __
B. WING _ _ _ _ _ _ _ __
0502025714 11/20/2015
7333 GATEWAY BLVD
T.HERANOSINC
NEWARK, CA 94560
TAG TAG
DEFICIENCY)

E000027 QC1 was run on 8/16/14 at 06:16 and
failed. QC1 was next run 8/17/14 at 09:10 and
passed. QC2 was not run on 8/15/14 or 8/16/14.
Patient data showed that patient Accession
#94598 was run on 8/16/14 at 00:48.
i. QC records for VB12 showed that on Device

E000027 QC2 24 hour expiration was on 8/19/14
at 08:00 and was not run again until 8/20/14 at
21 :05. Patient data showed that 3 patients
(Accession #s 95411, 95462, 95543) were run on
8/20/14 between 12:33 and 17:52.
j. QC records for VB12 showed that on Device

E000027 QC2 24 hour expiration was on 8/22/14
at 17:38 and was not run again until 8/23/14 at
21 :05. Patient data showed that 2 patients
(Accession #s 95984, 961.06) were run on
8/22/14 at 18:56 and 21 :21.
k. QC records for VB 12 showed that on Device

E000027 QC1's 24 hour expiration was on
8/25/14 at 07:59. QC2 24 hour expiration was on
8/24/14 at 21 :05 and was not run again until
8/25/14 at 12:23. Patient data showed that 3
patients (Accession #s 96327, 96250, 96371)
were run on 8/24/14 between 17:15 and 21:36.
I. QC records for VB12 showed that on Device

E000037 QC1 had a "1 Ox warning" message in
the QC Pass/Fail Status column on 2/25/15 at
20:29 and again on 2/26/15 at 20:22. QC2 had a
"1 Ox warning" message in the QC Pass/Fail
Status column on 2/25/15 at 22:11 and again on
2/26/15 at 22:04. QC1 passed on 2/27/15 at
22:54 and QC2 was run and passed on 2/28/15
at 00:27. Patient data showed that 7 patients
(Accession#s 146275, 146391, 146651, 146852,
J.::JV NOIJ.VW1IOif.NI i!O WOCTtltllii! 3HJ. cIHCIND. ffiIDSO'l:)SIQ W:Ocli! .ldW:HXH NOI.I'fli\raOif.NI 'l'fl:)1ItlWW0:) 'lVI.INHCili!NO:)
PRINTED: 01/25/2016
STATEMENT OF DEFICIENCIES (X1) PROVIDER/SUPPLIERICLIA (X2) MULTIPLE CONSTRUCTION {X3) DATE SURVEY
0502025714 B. WING _ _ _ _ _ _ _ __
11/20/2015
7333 GATEWAY BLVD
T!iERANOS INC
NEWARK, CA 94560
TAG
DEFICIENCY)

147149, 146596, 146898) were run between
2/26/15 and 2/27/15 during the time the
laboratory had a 1Ox warning.
m. QC records forVB12 showed that on Device

E001000 QC1's 24 hour expiration was on
1/25/15 at 21 :58 and was not run again until
1/28/15 at 2140. QC2 24 hour expiration was on
1/28/15 at 23:19. Patient data showed that 5
patients (Accession #s 136351, 136139,136386,
136897, 135548) were run between 1/27/15 at
1359 and 1/28/15 at 11:50.
n. QC records for Vitamin D, 25-0H (VitD)

showed that on Device EOO 1059 QC 1's 24 hour
expiration was on 7/6/14 at 14: 11 and was not run
again until 7n/15 at 08:04. Patient data showed
that Accession #88699 was run on 7/6/14 at
14:31.
o. Levey-Jennings charts revealed that SHBG

Device E000026 QC1 had 13 consecutive days
and QC2 had 15 consecutive days that the
results were at least 2 standard deviations (SDs)
below the mean from 9/30/14 through 10/29/14.
p. Levey-Jennings charts revealed that SHBG

that the results were at least 2 SDs below the
mean from 3/31/15 through 4/29/15.
q. Levey-Jennings charts revealed that Vito

that the results were at least 2 SDs above the
mean from 6/30/15 through 7/25/14.
r. Levey-Jennings charts revealed that Total T3

(TT3) Device E000195 QC1 had 11 consecutive
FORM CMS-2567(02-99) Previous Versions Obsolete Event ID:W34211 Facility ID: CA22D46272 If continuation sheet Page 40 of 121
.L;JV NOI.LVWROtlNI tlO womnrntI ffiI.L 1I'il<INO. ffiIDSO'I;JSia W01Itl .LcIWl3X'iI NOI.LVJi'ira:OtlNI 'IVI;J1Ifil'lWO;J 'IVI.LN'ilaitINO;J
PRINTED: 01/25/2016
f~ili ' STATEMENT OF DEFICIENCIES

A. BUILDING _ _ _ _ _ _ __
(X3) DATE SURVEY
COMPLETED
0502025714 B. WING _ _ _ _ _ _ _ __
11/20/2015
7333 GATEWAY BLVD
tHERANOSINC
NEWARK, CA 94560
TAG TAG
DEFICIENCY)

days that the results were at least 2 SDs above
the mean from 1/3/15 through 1/29/15.
s. Levey-Jennings charts revealed that TT3

results were at least 2 SDs above the mean from
7/9/14 through 7/25/14.
t.
Levey-Jennings charts revealed that VB12
results were at least 2 SDs above the mean from
2/10/14 through 2/27/14.
05775 493.1281 (a)(c) COMPARISON OF TEST
D5775 D5775 #1
RESULTS
4008 The lab proactively paused testing on 2/12/16
(a) If a laboratory perform$ the same test using the Cellavision during the survey. The
different methodologies or instruments, or lab has completed an assessment to
performs the same test at multiple testing sites, identify any patients affected or
the laboratory must have a system that twice a having the potential to be affected by
year evaluates and defines the relationship
between test results using the different this issue.
methodologies, instruments, or testing sites.
(c) The laboratory must document all test result The new lab director has approved
comparison activities. enhanced method comparison
This STANDARD is not met as evidenced by: procedures, which reinforce that the
1. Based on laboratory personnel interview and lab will compare the results of any
manual WBC differential record review on
November 19, 2015, the laboratory failed to have instruments running the same test(s) at
a system that twice a year evaluated and defined least twice each year to ensure that
the relationship between WBC differential test their results are comparable and within
results examined by multiple testing personnel. defined acceptance criteria. The lab
Findings included: has conducted training on those
a. It was the practice of the laboratory for
procedures.
multiple testing personnel to examine and report
patient WBC differentials from stained slides. The new lab director has also
.L:JV NOI.LVJi'raOIIN[ i[Q woml:3.c[i[ 3H.L 113:CINfl ffiIO.SO'I:JSra W01Itl .LcIW3.XH NOI.LVW1!01IN[ 'IVI:J1It!W:WO:J 'IVI.LNHCIItlNO:J
CONFIDENTIAL COMMERCIAL INFORMATION EXEMPT FROM DISCLOSURE UNDER TI:IE FREEDOM OF INFORMATION ACT
PRINTED: 01/25/2016
("cf@) STATEMENT OF DEFICIENCIES (X1) PROVIDER/SUPPLIER/CLIA (X2) MULTIPLE CONSTRUCTION (X3) DATE SURVEY
''{Jj} AND PLAN OF CORRECTION IDENTIFICATION NUMBER: A. BUILDING _ _ _ _ _ _ __ COMPLETED
0502025714 B. WING _ _ _ _ _ _ _ __
11/20/2015
7333 GATEWAY BLVD
THERANOSINC
NEWARK, CA 94560
TAG TAG
DEFICIENCY)
b. The laboratory had no system that twice a

05775 ~:;:~:J e:::~:~e:~ocedures for the
Cellavision instrument to ensure that
year evaluated and defined the relationship the lab evaluates and defines the
between WBC differential test results examined relationship between WBC differential
by multiple testing personnel. other than through test results examined by multiple
the distribution of proficiency testing samples, the testing personnel at least twice each
laboratory had no documentation to indicate year. Before the lab resumes any tests
whether testing personnel were examining patient
on the Cellavision, it will conduct
stained slides and reporting patient manual WBC
differential similarly, accurately, and reliably. training and competency testing on
those procedures to ensure that
2. Based on review of documentation, the practice is consistent with them.
laboratory failed to have a system that twice a
year evaluated and defined the relationship
The lab's technical supervisors and the
between the Theranos Proprietary System (TPS)
····... to a predicate instrument. Findings include:' quality systems director will be
responsible for ensuring that these
a. Undated documentation provided by the procedures are followed. The lab will
laboratory revealed a comparison study between provide oversight through monthly
the Theranos Proprietary System (TPS) (i.e., QA meetings, and will monitor
Edison) and a predicate device (lmmulite,
Centaur, or Liaison) for Sex Hormone Binding
Globulin (SHBG), Total T3 (TT3), Vitamin D (Vito) occurrence management, and audit
and Vitamin 812 (VB12). procedures.
b. The method comparison documentation

showed that the following devices (i.e., readers)
E000026, E001025 and E001036 were used for
SHBG comparison testing. SHBG testing
occurred from 7/28/14 through 6/25/15.
c. Quality control (QC) monthly reports revealed

that seven devices were used for SHBG from
February 2015 through June 2015 but only three
devices were included in the comparison study.
d. QC and patient result documentation for

SHBG also revealed that devices E000040,
E001007 and E001035 were used for patient
J.:JV NOIJ.VWRO.!INI dO WOOHHffiI HHL 113:<INO. ffiIOSO'I:)SIO W01Id J.cIWHXH NOllVWRO.!lNI 'IVI:::rnffii'ffi:O:) 'IVI.LNHOidNO:)
PRINTED: 01/25/2016
!%}> STATEMENT OF DEFICIENCIES (X1) PROVIDER/SUPPLIER/CUA (X2) MULTIPLE CONSTRUCTION (X3) DATE SURVEY
\@ \ AND PLAN OF CORRECTION IDENTIFICATION NUMBER: A. BUILDING _ _ _ _ _ _ __ COMPLETED
0502025714 B. WING _ _ _ _ _ _ _ __
11/20/2015
7333 GATEWAY BLVD
THERANOSINC
NEWARK, CA 94560
TAG
DEFICIENCY)
b. The laboratory had no system that twice a

between WBC differential test results examined
by multiple testing personnel. other than through
the distribution of proficiency testing samples, the
laboratory had no documentation to indicate
whether testing personnel were examining patient
stained slides and reporting patient manual WBC
differential similarly, accurately, and reliably.
D5775 #2
2. Based on review of documentation, the The lab has completed an assessment 2/12/16
laboratory failed to have a system that twice a to identify any patients affected or
between the Theranos Proprietary System (TPS)
to a predicate instrument. Findings include:' this issue.
a. Undated documentation provided by the The new lab director has approved
laboratory revealed a comparison study between enhanced method comparison
the Theranos Proprietary System (TPS) (i.e., procedures, which reinforce that the
Edison) and a predicate device (lmmulite,
Centaur, or Liaison) for Sex Hormone Binding
lab will compare the results of any
Globulin (SHBG), Total T3 (TT3), Vitamin D (Vito) instruments running the same test(s) at
and Vitamin 812 (VB12). least twice each year, to ensure that
their results are comparable and within
b. The method comparison documentation defined acceptance criteria. The lab
showed that the following devices (i.e., readers) has conducted training on those
E000026, E001025 and E001036 were used for
SHBG comparison testing. SHBG testing
procedures.
The lab's technical supervisors and the
c. Quality control (QC) monthly reports revealed quality systems director will be
that seven devices were used for SHBG from responsible for ensuring that these
February 2015 through June 2015 but only three procedures are followed. The lab will
devices were included in the comparison study.
provide oversight through monthly
d. QC and patient result documentation for QA meetings, and will monitor
SHBG also revealed that devices E000040,
E001007 and E001035 were used for patient
FORM CMS-2567(02-99) Previous Versions Obsolete Event ID:W34211 Fac!lity ID: CA22046272 If continuation sheet Page 42 of 121
J.:JV NOIJ.Vli'ffiOif.NI .!IO WOOtltIB.il 3H.L 1IHCIN(l 81JTIS0'1:JSIQ WOM J.cIWHXH NOIJ.VJi'raOif.NI 'IVI:J1IHWWO:J 'IVIJ.NHGBNO:J
l.:JV NOil.V})IIBOdNI .ilO WOQHffild HH.L 1IHCINfl ffiIOS0'1:JSIQ W01Id l.cJlilJI!XH NOil.VJllrnOdNI '1VI:J1IHWWO:J 'lVIl.NHOidNO:J
PRINTED: 01/25/2016
f@}O, STATEMENT OF DEFICIENCIES (X1) PROVIDER/SUPPLIER/CUA (X2) MULTIPLE CONSTRUCTION (X3) DATE SURVEY
\!EN AND PLAN OF CORRECTION IDENTIFICATION NUMBER: A. BUILDING _ _ _ _ _ _ __ COMPLETED
0502025714 B. WING _ _ _ _ _ _ _ __
11/20/2015
7333 GATEWAY BLVD
l'HERANOSINC
NEWARK, CA 94560
TAG
DEFICIENCY)
05775 Continued From page 42 05775 comp1·iance through its
. rmprove
. d
testing and were not included in the comparison
study.
occurrence management, and audit
procedures.
e. The method comparison documentation
showed that the following devices E000162,
E000187, E00195, E001011, E001032, and
E001049 were used for TT3 testing. TT3 testing
f. The method comparison documentation

E000072, E00101, E0001157, E001007,
E001043, and E001059 were used for VitD
testing. VitD testing occurred from 11/6/13
through 3/10/15.
·- ...
g. Quality control (QC) monthly reports revealed
that twelve devices were used for VitD in
February 2015 and eighteen devices were used
from March 2015 through April 2015 but only
seven devices were included in the comparison
study.
h. QC and patient result documentation for VitD

also revealed that device E001059 was used for
patient testing and was not included in the
comparison study.
i. The method comparison documentation

E000072, E00101, E0001157, E001007,
E001043, and E001059 were used forVB12
testing. VB12 testing occurred from 8/12/14
through 3/6/15.
j. Quality control (QC) monthly reports revealed

that twelve devices were used for VB12 in
October 2014 and February 2015 through April
2015 but only eleven devices were included in the
.L:JV NOI.LVli'nIO.!INI 110 woa'iiffiTll 'iIHL 1I'iICINfl ffiT(lSO'I:JSia W01!11.L~3X'iI NOI.LVJArnO.!INI 'IVI:J1I'iIWWO:J 'IVI.LN'iIGIIINO:J
CONFIDENTIAL COMMERCIAL INFORMATION EXEMPT FROM DISCLOSURE UNDER THE FREEDOM OF JNFORMATION ACT
PRINTED: 01/25/2016
{@:) STATEMENT OF DEFICIENCIES (X1) PROVIDER/SUPPLIER/CLIA (X2) MULTIPLE CONSTRUCTION (X3) DATE SURVEY
~t;:;O AND PLAN OF CORRECTION IDENTIFICATION NUMBER: A. BUILDING _ _ _ _ _ _ __ COMPLETED
0502025714 B. WING _ _ _ _ _ _ _ __
11/20/2015
NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE. ZIP CODE
7333 GATEWAY BLVD
THERANOS INC
NEWARK, CA 94560
TAG TAG
DEFICIENCY)

comparison study.
05779 493.1282(a) CORRECTIVE ACTIONS 05779 DS?1 9
4008 Corrective action policies and procedures must to identify any patients affected or 2/12/16
be available and followed as necessary to having the potential to be affected by
maintain the laboratory's operation for testing this issue.
patient specimens in a manner that ensures
accurate and reliable patient test results and
reports.
This STANDARD is not met as evidenced by: reinforce and detail the required
Based on laboratory personnel interviews and investigation and corrective action that
complete blood counts (CBC) quality control must occur to address QC issues
record review on September 23, 2015, the before patient tests are performed. In
laboratory failed to follow corrective action
policies and procedures as necessary to maintain
addition, the procedures clarify which
the laboratory's operation for testing patient CBC employees are responsible for
specimens in a manner that ensure accurate and performing and documenting these
reliable patient test results and reports when the activities, and require regular technical
laboratory's criteria for acceptability of CBC supervisor review and analysis of QC
quality control material test results were not met. results. The lab has conducted
Findings included:
training and competency testing on
a. It was the practice of the laboratory to test those procedures to ensure that
three levels (low, normal, and high) of quality practice is consistent with them.
control materials each day of patient testing and
to use the stated values of commercially assayed Lab management, including technical
quality control materials to monitor patient CBC supervisors and the quality systems
testing using the Drew 3 instruments. In the
event any CBC quality control material test results director, is responsible for ensuring
did not fall within the stated assay values,
laboratory personnel were to follow the procedure
detailed in the protocol titled "Quality Control
(document number CL QOP-00013, revision F)."
i. "Step 1" of the procedure was to "rerun the

controls."
.L::)V NOI.LVV'rnOi!NI dO worniffild 3H.L 1:ItICINfl ffilflS01:)SIG W01:Id .LdW3XtI NOI.LVV'rnOi!NI 1VI:)1:J:t1WW0:) 1VI.LN3GBN0:)
PRINTED: 01/25/2016
B. WING _ _ _ _ _ _ _ __
0502025714 11/20/2015
7333 GATEWAY BLVD
THERANOSINC
NEWARK, CA 94560
(X4) ID SUMMARY STATEMENT OF DEFICIENCIES JD PROVIDER'S PLAN OF CORRECTION (XS)
DEFICIENCY)
D5779 (continued)
05779 Continued From page 44 05779 comp1'rnnce wit
. h these procedures.
ii. "Step 211 of the procedure was to "repeat with
fresh controls" "if the rerun of controls failed." The lab will also provide oversight
through monthly QA meetings, and
iii. "Step 3" of the procedure was to "check the will monitor compliance through its
operation of the instrument" "if the rerun of [fresh] improved occurrence management and
controls failed." audit procedures.
iv. "Step 4" of the procedure was to "repeat
using a new reagent kit" and "recalibrate" if
quality control test results continued to fall outside
the laboratory's criteria for acceptability.
v. "Step 5" of the procedure was to "call

instrument support and inform [the] supervisor" if
quality control test results continued to fall outside
the laboratory's criteria for acceptability.
b. Laboratory records for the Drew 3 instrument

the laboratory designated as "Drew #2" indicated
that on July 11, 12, 14, and 16, 2015 CBC quality
control material test results failed to meet stated
assay values. The laboratory's documentation of
these quality control failures indicated that the
laboratory's "Quality Control" protocol was not
followed.
i. On July 12, 2015, laboratory records

indicated that the high quality control material
failed to meet the laboratory's criteria for
acceptability (specific CBC analyte not
designated). Testing of the high quality control
material was repeated three times before being
acceptable using a "new QC tube." "Step 1" was
repeated three times before the laboratory
followed "Step 2."
ii. On July 16, 2015, laboratory records

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CONFIDENTIAL COMMERCIAL INFORMATION EXEMPT FROM DISCLOSURE UNDER THE FREEDOM OF lNFORMATION ACT
PRINTED: 01/25/2016
DEPARTI\IIENT OF HEALTH AND HUMAN SERVICES FORM APPROVED
B. WING _ _ _ _ _ _ _ __
0502025714 11/20/2015
7333 GATEWAY BLVD
THERANOS INC
NEWARK, CA 94560
TAG TAG
DEFICIENCY)

material was repeated two times before being
acceptable on a third repeat. "Step 1" was
repeated two times without following "Step 2."
iii. On July 17, 2015, laboratory records

material was repeated two times before being
acceptable on a third repeat. "Step 1" was
repeated two times without following "Step 2."
[NOTE: On July 11 and 14, 2015, laboratory

records also indicated that the high quality control
material failed to meet the laboratory's criteria for
designated). Testing was repeated and was
acceptable. "Step 1" was followed.]
[NOTE: On July 14, 2015, laboratory records also

indicated that the normal quality control material
designated). Testing was repeated and was
acceptable. "Step 1" was followed.]
c. Laboratory records indicated that the Drew 3

instrument the laboratory designated as "Drew
#2" was used to test and report 36 patient CBC
specimens on July 11, 2015, 12 patient CBC
specimens on July 14, 2015, and 45 patient CBC
specimens on July 16; 2015. It is unknown how
many patient CBC specimens were tested using
"Drew#2" on July 17, 2015.
l.:::>V NOI.LVl'\IBOdNI dO WOGHffild ffiU ~HCINJ1 ffiillSO'I:)SIG WO~ ldJtl1HXH NOI.LVPrnOdNI '1VI:)~HWJIII0:) '1Vll.NHGidN0:)
PRINTED: 01/25/2016
0502025714 B. WING _ _ _ _ _ _ _ __
11/20/2015
7333 GATEWAY BLVD
THERANOS INC
NEWARK, CA 94560
(X4}1D SUMMARY STATEMENT OF DEFICIENCIES ID PROVIDER'S PLAN OF CORRECTION (X5)
REGULATORY OR LSC IDENTIFYING INFORMATION} CROSS-REFERENCED TO THE APPROPRIATE DATE
TAG TAG
DEFICIENCY)
05787 Continued From page 46 05787 D5787

05787 493.1283{a) TEST RECORDS 05787
The lab is keeping records that track 2/12/16
110H The laboratory must maintain an information or the media used to test any given
record system that includes the following: bacteriology patient specimen.
(a)(1) The positive identification of the specimen.
(a)(2) The date and time of specimen receipt into The lab has completed an assessment
the laboratory. to identify any patients affected or
(a)(3) The condition and disposition of specimens
that do not meet the laboratory's criteria for having the potential to be affected by
specimen acceptability. this issue.
(a)(4) The records and dates of all specimen
testing, including the identity of the personnel who The new lab director has approved
performed the test(s). enhanced procedures regarding
documentation of the bacteriology
Based on technical supervisor interview and
bacteriology media quality control record review media used to test patient specimens.
on November 18, 2015, the laboratory failed to
have an information or record system that The lab will ensure these procedures
included the records of all bacteriology patient are followed through audits performed
specimen testing. Findings included: pursuant to the lab's new audit
procedures, and through oversight
Although the laboratory maintained
documentation to indicate that all lots of during the monthly QA meetings.
bacteriology media used to test patient
bacteriology specimens had been quality
controlled by the manufacturer or laboratory, the
laboratory maintained no documentation of the lot
of media used to test any given patient
bacteriology specimen. The laboratory
maintained no such information or record system.
05791 493.1289(a)(c) ANALYTIC SYSTEMS QUALITY 05791 D5791 #1
ASSESSMENT A review of hourly data demonstrated 2/12/16
(a) The laboratory must establish and follow nearly all of the freezers at issue met
written policies and procedures for an ongoing
the manufacturer temperature
mechanism to monitor, assess, and when
indicated, correct problems identified in the requirements for the materials stored.
analytic systems specified in
J..::)\f NOllW'IBOilNI tlO WOQHffiH filll 1:13:CINfl ffilfl.SO'l::)SIQ WOfil .ldW3X3: NOIJ..W'IBOilNI '1\fl::)1:13:WWO::) '1VIJ..N3:QitlN0::)
PRINTED: 01/25/2016
fi:) STATEMENT OF DEFICIENCIES (X1) PROVIDER/SUPPLIER/CUA (X2) MULTIPLE CONSTRUCTION (X3) DATE SURVEY
~;;;]{) AND PLAN OF CORRECTION IDENTIFICATION NUMBER: A. BUILDING _ _ _ _ _ _ __ COMPLETED
0502025714 B. WING _ _ _ _ _ _ _ __
11/20/2015
7333 GATEWAY BLVD
THERANOSINC
NEWARK, CA 94560
TAG TAG
DEFICIENCY)
The lab has identified and discarded
§§493.1251 through 493.1283.
(c) The laboratory must document all analytic
any materials that had the potential to
systems assessment activities. have been affected. The lab has also
completed an assessment to identify
This STANDARD is not met as evidenced by: any patients affected or having the
1. Based on the SensoScientific Monitoring potential to be affected by this issue.
Audit Node Report and intervew, the laboratory
failed to identify and perform corrective action
when ten of ten freezer temperatures did not
meet the manufacturer temperature enhanced temperature management
requirements. Findings include: procedures to reinforce monitoring of
temperature and environmental
a. The Audit Node Reports for July 2015 and conditions and storage of materials
September 2015 were reviewed.
according to the manufacturer's
b. Six -20 C freezers were identified: 7059 -20 temperature range. The lab has
Freezer Sanyo JP lab, 7061 BUGS -20 Freezer 4, conducted training on those
7063 -20 Freezer Accessioning, 7066 -20 Freezer procedures.
1 Normandy, 7075 -20 Freezer 2 JP, and 7077
-20 Freezer 3JP. The lab's management, including the
c. Four -80 C freezers were identified: 7098 -80
new lab director and quality systems
Freezer 1 Nuair, 7111 -80 Freezer 2 Thermo, director, will ensure compliance with
7113 -80 Freezer 2 CLIA Lab, and 7120 -80 these procedures, including by making
Freezer 1 BUGS. sure that supervisors perform their
respective duties effectively. The lab
d. The Audit Node Report for 7/6/15 through will also provide oversight through
7/31/15 revealed the following number of days
that the freezers did not meet the required
acceptable temperature range of greater than or monitor compliance through its
equal to -20 C or greater that or equal to -80 C: improved occurrence management and
audit procedures.
7059 -20 Freezer Sanyo JP Lab 25/26 days
7098 -80 Freezer 1 Nuair 7/26 days
7111 -80 Freezer 2 Thermo 18/26 days
7113 -80 Freezer 2 CLIA Lab 14/26 days
7120 -80 Freezer 1 BUGS 25/26 days
e. The Audit Node Report for 9/1/15 through

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PRINTED: 01/25/2016
.,ff\\ STATEMENT OF DEFICIENCIES (X1) PROVIDER/SUPPLIER/CUA (X2) MULTIPLE CONSTRUCTION (X3) DATE SURVEY
\@) AND PLAN OF CORRECTION IDENTIFICATION NUMBER: A. BUILDING _ _ _ _ _ _ __ COMPLETED
0502025714 B. WING _ _ _ _ _ _ _ __
11/20/2015
7333 GATEWAY BLVD
THERANOSINC
NEWARK, CA 94560
TAG TAG
DEFICIENCY)

9/24/15 revealed the following number of days
that the freezers did not meet the required
acceptable temperature range of greater than or
equal to -20 C or greater that or equal to -80 C:
7059 -20 Freezer Sanyo JP Lab 12/24 days

7061 BUGS -20 Freezer 4 12/24 days
7063 -20 Freezer Accessioning 11/24 days
7066 -20 Freezer 1 Normandy 9/24 days
7075 -20 Freezer 2 JP 6/24 days
7077 -20 Freezer 3JP 5/24 days
7098 -80 Freezer 1 Nuair 11/24 days
7111 -80 Freezer 2 Thermo 3/24 days
7113 -80 Freezer 2 CUA Lab 10/24 days
7120 -80 Freezer 1 BUGS 18/24 days
f. The Quality Assurance Quality Control

Manager signed and dated the Audit Node
Reports. The Quality Assurance Quality Control
Manager could not explain if any corrective action
was taken.
g. There was no documenation that the

laboratory identified the days that the freezers did
not meet the acceptable temperature ranges and
did not take any corrective action for those days.
h. Refer to 05413.
2. Based on review of Quality Control (QC) data D5791 #2

and Monthly QC Reports, the laboratory failed to The lab has completed an assessment 2/12/16
have a quality assessment'(QA) procedure to to identify any patients affected or
identify and correct problem with the QC values having the potential to be affected by
for the Theranos Proprietary System (TPS) when this issue.
precision did not meet the laboratory's
requirement for precision. Findings include:
The new lab director is responsible for
a. CL PLN-14003 Revision A, "Master Validation the lab's QA program and has
Plan for Routine Chemistry Assays on Theranos
l:)V NOI.LVJAIBOtlNI tlO womnnw: ffill 113:CIN11 ffilflS0'18SIQ WO~ .LdW3X3: NOI.LVJAIBOtlNI '1VD113WW08 '1VI.LN3:aitlN08
PRINTED: 01/25/2016
,w::.
t]{Q)
(X2) MULTIPLE CONSTRUCTION (X3) DATE SURVEY
COMPLETED
A. BUILDING _ _ _ _ _ _ __
0502025714 B. WING _ _ _ _ _ _ _ __
11/20/2015
7333 GATEWAY BLVD
THERANOS INC
NEWARK, CA 94560
TAG
DEFICIENCY)
05791 #2 (continued)
approved enhanced quality systems
Devices" in section 13.4.5 requires the %CV of
replicates to be not more than 15% (20% at the
and related procedures. The lab has
lower and upper limits of detection). also appointed a Quality Director who
will provide additional oversight.
b. QC results were reviewed from June 2014
through November 2014 and January through These improved systems include QC
February2015 for Vitamin 812 (VB12), Vitamin D
procedures to reinforce that QC is
(Vito), and Sex Hormone Binding Globuin
(SHBG) which were used for patient testing on effectively reviewed to identify
the TPS devices. precision that is inconsistent with the
lab's CV requirements and that
c. VB12 QC Level 1 and Level 3 (QC1 and documented investigations and
QC3) on Device E000110 revealed the following corrective action occur. In addition,
%CV (coefficient of variation): 34.3% and 48.5%,
the procedures clarify which
respectively, from 1/5/15 through 1/30/15.
employees are responsible for
d. V812 QC1 and QC3 on.DeviQe E001085 performing and documenting these
revealed the following %CVs: 52.5% and 35.2%, activities, and require regular technical
respectively, from 1/5/15 through 1/30/15. supervisor review and analysis of QC
results. The lab has conducted training
e. VB12 QC1 and QC3 on Device E001102
revealed the following %CVs: 39.0% and 20.0%,
and competency testing on those
respectively, from 2/10/15 through 2/27/15. procedures to ensure that practice is
consistent with them.
f. VB12 QC1 and QC3 on Device E001000
revealed the following o/oCVs: 34.7% and 39.9%, Lab management, including technical
respectively, from 1/2/15 through 1/31/15. supervisors and the quality director,
g. VB12 QC1 and QC3 on Device E001102
are responsible for compliance with
revealed the following %CVs: 39.0% and 20.0%, these procedures. The lab will also
respectively, from 2/10/15 through 2/27 /15. provide oversight through monthly
QA meetings, and will monitor
h. Vito QC Level 1 and Level 2 (QC1 and QC2) compliance through its improved
on Device E000053 revealed the following o/oCVs:
occurrence management and audit
63.8% and 26.4%, respectively, from 8/21/14
through 8/30/14. procedures.
i. Vito QC1 and QC2 on Device E001059

J.:::>v NOilVJ!'IBOdNI dO WOG3IITul ffifl ~3CINO. ffiID.S01::>SIG WOfil ldW3X3 NOUVJIIIBOdNI 1VI::>113WWO::> 1VIJ.N3GldNO::>
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0502025714 B. WING _ _ _ _ _ _ _ __
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j. VitD QC1 and QC2 on Device E001043

k. SHBG QC1 on Device E001026 revealed the

following %CV: 18.9% from 9/30/14 through
11/5/14.
I. SHBG QC1 on Device E001025 revealed the

following %CV: 21.2% from 7/31/14 through
8/28/14.
3. Based on review of Quality Assessment (QA)

D5791 #3
documentation and QA procedures, the The lab has completed an assessment 2//12/16
laboratory failed to have a quality assessment to identify any patients affected or
(QA) procedure established to identify and correct having the potential to be affected by
problems with the Quality Control (QC) program this issue.
for the Theranos Proprietary System (TPS) .
Findings include:
a. Monthly QC reports were reviewed for July the lab's QA program and has
2014, October 2014, and February through June approved enhanced quality systems
2015. and related procedures. The lab has
also appointed a Quality Director who
b. All reports were signed by the laboratory will provide additional oversight.
director (LD) on 9/19/15, except the March 2015
report was signed by the LD on 11 /19/15.
These improved systems include
c. The total percentage of QC values greater enhanced QC procedures, which
than 2 standard deviations (SDs) was reviewed reinforce and detail the required
by the surveyor. investigation and corrective action that
must occur to address QC issues
d. The July 2014 report indicated in the
summary that 2179 controls had been run on the before patient tests are performed. In
"Edison**" devices; however, the specific report addition, they clarify which employees
on the "Edison**" device showed that only 1618 are responsible for performing
were run on all tests and all devices.
l:)V NOllVJ-'ffiOdNI dO Ji\l:OCTHffilil 3:H.L 1!3:CIN!1 ffiillSO'DSia W01Id .LdW3X3: NOllVVffiOdNI 'TVI::mHWWO::> 'TVI.LN3:GidNO::>
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DEPARTfy'IENT OF HEALTH AND HUMAN SERVICES FORM APPROVED
0502025714 B. WING _ _ _ _ _ _ _ __
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(X4) ID SUMMARY STATEMENT OF DEFICIENCIES ID PROVIDER'S PLAN OF CORRECTION (X6J
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e. In July 2014, the data revealed the following and documenting these activities, and
tests showed percentage of QC samples with require regular technical supervisor
more than 15% of values greater than 2 SD: review and analysis of QC results. The
Testosterone (TST) (28%), Total T4 (TT4) (21%), lab has conducted training and
VitD (28%). Overall 16% of QC samples on all competency testing on those
tests on all devices had values greater than 2 procedures to ensure that practice is
sos.
f. In October 2014, the data revealed the
following tests showed percentage of QC Lab management, including technical
samples with more than 15% of values greater supervisors and the quality director, is
than 2 SD: Estradiol (EST) (33%), Free T4 (FT4) responsible for compliance with these
(19%), Prolactin (PRLN) (47%), SHBG (45%),
Thyroid Stimulating Hormone (TSH) (26%), TST
procedures. The lab will also provide
(45%), Total T3 (TT3) (32%), TT4 (28%), Vito oversight through monthly QA
(19%), VB12 (46%). Overall 29% of QC samples meetings, and will monitor
on all tests on all devices had values greater than compliance through its improved
2 SDs. occurrence management and audit
procedures.
g. In February 2015, the data revealed the
following tests showed percentage of QC .
samples with more than 15% of values greater
than 2 SD: FT4 (26%), SHBG (87%), TT3 (33%),
VitD (24%), VB12 (20%). Overall 24% of QC
samples on all tests on all devices had values
greater than 2 SDs.
h. In March 2015, the data revealed the

following tests showed percentage of QC
samples with more than 15% of values greater
than 2 SD: SHBG (42%), TSH (20%). Overall
20% of QC samples on all tests on all devices
had values greater than 2 SDs.
i. In April 2015, the data revealed the following

tests showed percentage of QC samples with
more than 15% of values greater than 2 SD:
SHBG (16%), total Prostate Specific Antigen
.L:::>V NOllVY'IBO.iNI dO WOG3:3}B 3:H.L 113:CINfl ffililSO'l:::>SIG WOfil .LdJIII3:X3: NOI.LVY'IBO.iNI 'lVI:::>113:WWO:::> 'lVI.LN3:GidNO:::>
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(tPSA) (22%), VB12 (60%). Overall 21% of QC
greater than 2 SDs.
j. In May 2015, the data revealed the following

SHBG (34%), tPSA (22%). Overall 26% of QC
greater than 2 SDs.
k. In June 2015, the data revealed the following

SHBG (23%). Overall 14% of QC samples on all
tests on all devices had values greater than 2
SDs.
D5791 #4
4. Based on review of the quarterly Quality As noted by CMS above, if a patient 2/12/16
Assessment (QA) Power Points and interview specimen did not meet the lab's
with the QA/Quality Control (QC) Manager, the
laboratory failed to identify and correct problems
acceptance criteria, the lab's practice
with drawing patient specimens. Findings include: was to describe the issue in its
electronic system, to notify relevant
a. The QA/AC Manager stated that a Power lab personnel, and to take, and
Point presentation was prepared and presented electronically note, appropriate
to specific staff each quarter and that no minutes corrective action. Patient specimens
or corrective actions were documented.
that did not meet the lab's acceptance
b. The QA presentation from the 3rd quarter criteria were not used for testing.
2014 showed that the number 1 reason that
patient specimens had to be redrawn was clots The new lab director is responsible for
(293). the lab's QA program and has
c. The QA presentation from the 1st quarter
2015 showed that the number 1 reason that and related procedures. The lab has
patient specimens had to be redrawn was clots also appointed a Quality Director who
(246). will provide additional oversight.
1.:JY NOLL"WrnOi!NI tlO li\l:OCT3:ffiB 3:Hl. "}13:CINfl ffiUlSO'USICT WQ"}ltl 1.dY\I3XH NOLL"WrnOi!NI '1YJ:J"}l3:WW0:J '1YI1.N3:CTitlNO:J
CONFIDENTIAL COMMERCIAL JNFORMATION EXEMPT FROM DISCLOSURE UNDER THE FREEDOM OF INFORMATION ACT
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d. The QA presentation from the 2nd quarter
patient specimens had to be redrawn was clots enhanced specimen rejection
(116). procedures, which require the relevant
lab personnel to further monitor and
e. There was no documentation which showed assess received patient specimens and
that the lab had identified the large number of to correct problem as needed.
redraws due to clots or that any action had been
taken to correct the number of redraws due to
clots. During monthly QA meetings, the lab
05793 493.1289(b)(c) ANALYTIC SYSTEMS QUALITY 05793 will review, among other things,
ASSESSMENT specimen rejection rates and any
4008 associated issues. In addition, the lab
(b) The analytic systems quality assessment must will monitor compliance through its
include a review of the effectiveness of corrective
improved occurrence management and
actions taken to resolve problems, revision of
policies and procedures necessary to prevent audit procedures, both of which
recurrence of problems, and discussion of address preanalytic activities.
analytic systems quality assessment reviews with
appropriate staff.
(c) The laboratory must document all analytic
systems assessment activities.
complete blood counts (CBC) quality control and
calibration record review on September 23, 2015,
the laboratory failed to have an analytic systems
quality assessment mechanism that included a
review of the effectiveness of the laboratory's
CBC processes. Finding included:
a. The laboratory's Siemens Advia 2120i

procedure failed to include the corrective actions
to be taken when calibration or quality control
acceptability. See 05403.
b. The laboratory's quality assessment
l:)V NOIJ..VJAraO.,JNI dO WOCT3illld 3Hl. 113:CIN[l ffilflSO'I:>Sia W01!d l.cWi!3X3: NOIJ..VJAraO.,JNI 'lVl::ma:wwo:J 'lVIJ..N3GldNO:J
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d. The QA presentation from the 2nd quarter
patient specimens had to be redrawn was clots
(116).
e. There was no documentation which showed

that the lab had identified the large number of
redraws due to clots or that any action had been
taken to correct the number of redraws due to
clots.
05793 493.1289(b)(c) ANALYTIC SYSTEMS QUALITY 05793 D5793 #1
ASSESSMENT The laboratory proactively paused 2/12/16
4008 testing on the Advia 2120i during the
(b) The analytic systems quality assessment must survey. The lab has completed an
include a review of the effectiveness of corrective
actions taken to resolve problems, revision of
assessment to identify any patients
policies and procedures necessary to prevent affected or having the potential to be
recurrence of problems, and discussion of affected by this issue.
analytic systems quality assessment reviews with
appropriate staff. The new lab director is responsible for
(c) The laboratory must document all analytic the lab's QA program and has
systems assessment activities.
1. Based on laboratory personnel interviews and and related procedures. The lab has
complete blood counts (CBC) quality control and also appointed a Quality Director who
calibration record review on September 23, 2015, will provide additional oversight.
the laboratory failed to have an analytic systems
review of the effectiveness of the laboratory's
CBC processes. Finding included: enhanced QC procedures that address,
among other things, parallel testing to
a. The laboratory's SiemensAdvia 21201 verify QC values; review of QC data,
procedure failed to include the corrective actions including regular review by technical
to be taken when calibration or quality control supervisors; and investigation·and
correction action to take when QC
acceptability. See 05403.
fails to meet the lab's criteria for
b. The laboratory's quality assessment
J..:)V NOJ.LVJ."raO.':lNI dO WOG3ffild 3HJ.. 1:13CINfl ffiillSO'USIG W01:Id J..dli'J:3X3 NOIJ..VJ."raOdNI '1VJ:)1:13WW0:) '1VIJ..N3GidNO:)
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D D5793 #1 (continued)
mechanism failed to ensure that all CBC
calibration documentation was maintained. See
acceptability. The lab has conducted
05437. training on those procedures.
c. The laboratory's quality assessment The new lab director has also
mechanism failed to ensure that the stated values approved enhanced procedures
of commercially assayed CBC quality control addressing equipment systems and
materials were verified. See 05469.
reinforcing that calibration
d. The laboratory's quality assessment documentation must be organized and
mechanism failed to ensure that laboratory maintained. The lab has conducted
personnel followed the established corrective training on those procedures.
action protocol when CBC quality control test
The new lab director has also
acceptability even though the laboratory
maintained documentation to indicate that the approved an enhanced SOP for CBC
documented CBC quality control corrective on the Advia 2120i that addresses the
actions had been reviewed during a quality corrective actions to take when
assessment audit on August 6, 2015. In addition, calibration or QC fail to meet the lab's
the laboratory maintained no documentation it criteria for acceptability. Before the
had recognized and investigated possible
problems with the high quality control material
lab resumes any tests on the Advia
being used as it had failed to meet the 2120i, it will conduct training on those
laboratory's criteria for acceptability upon initial procedures. In addition, lab staff will
testing for 5 of 7 days of patient specimen testing be required to demonstrate
from July 11, 2015 to July 17, 2015. See 05779. competency to ensure that practice is
consistent with these procedures.
WBC differential flow cytometer performance
report record review on November 17, 2015, the Lab management, including technical
laboratory failed to have an analytic systems supervisors and the quality director, is
quality assessment mechanism that included a responsible for compliance with these
review of the effectiveness of flow cytometer procedures. The lab will provide
corrective actions taken to resolve problems. oversight through monthly QA
Findings included:
a. For patient capillary specimens, it was the compliance through its improved
practice of the laboratory to use flow cytometry occurrence management, and audit
instrumentation to perform and report patient procedures.
FORM CMS-2567(02-99) Previous Versions Obsolete Event ID:W34211 Faclllty JD: CA22046272 If continuation sheet Page 55 of 121
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mechanism failed to ensure that all CBC
calibration documentation was maintained. See
05437.
c. The laboratory's quality assessment

mechanism failed to ensure that the stated values
of commercially assayed CBC quality control
materials were verified. See 05469.
d. The laboratory's quality assessment

mechanism failed to ensure that laboratory
personnel followed the established corrective
action protocol when CBC quality control test
acceptability even though the laboratory
maintained documentation to indicate that the
documented CBC quality control corrective
actions had been reviewed during a quality
assessment audit on August 6, 2015. In addition,
the laboratory maintained no documentation it
had recognized and investigated possible
problems with the high quality control material
being used as it had failed to meet the
laboratory's criteria for acceptability upon initial
testing for 5 of 7 days of patient specimen testing
from July 11, 2015 to July 17, 2015. See 05779.
D5793 #2
WBC differential flow cytometer performance
report record review on November 17, 2015, the the flow cytometer during the survey.
laboratory failed to have an analytic systems
quality assessment mechanism that included a The lab has completed an assessment
review of the effectiveness of flow cytometer to identify any patients affected or
corrective actions taken to resolve problems. having the potential to be affected by
Findings included:
this issue.
a. For patient capillary specimens, It was the
practice of the laboratory to use flow cytometry
instrumentation to perform and report patient
.L::)V NOI.LVM:1000 tlO WOCT3:ffiltl 3H.L 1:l:3:CINf1 ffilflSO'lJSia WO~ .Ldli\I3:X3: NOI.LVWl:IOtlNI 'lVI:::ma:wwo::> '1VI.LN3:aitlNO::>
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DEPARTf\{lENT OF HEALTH AND HUMAN SERVICES FORM APPROVED
tlH\ STATEMENT OF DEFICIENCIES (X1) PROVIDER/SUPPLIER/CUA (X2) MULTIPLE CONSTRUCTION (X3) DATE SURVEY
%@jj) AND PLAN OF CORRECTION IDENTIFICATION NUMBER: A. BUILDING _ _ _ _ _ _ __ COMPLETED
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o5793 The new lab director is responsible for
WBC differentials.
the lab's QA program and has
b. On August 23, 2015, in which the flow approved enhanced quality systems
cytometer was used to perform and report patient and related procedures. The lab has
WBC differentials, laboratory "Cytometer also appointed a Quality Director who
Performance Reports" indicated that at 09:30 the will provide additional oversight.
flow cytometer performance check failed. The
performance check was repeated and again
failed at 1O: 18. At 12:49, laboratory The new lab director has approved
documentation indicated that the flow cytometer enhanced procedures to reinforce the
performance check passed. practice of addressing a performance
check fail through documented
c. The laboratory maintained no documentation investigations and corrective action.
to indicate that the actions taken on August 23, The lab has conducted training on
2015 to "pass" the flow cytometer performance
check had been reviewed for the effectiveness of those procedures.
the actions under the laboratory's quality
assessment mechanism. Lab management, including technical
supervisors and the quality director,
3. Based on technical supervisor interviews and are responsible for compliance with
human chorionic gonadotropin {HCG) quality
control record review on November 19, 2015, the
these procedures. The lab will provide
laboratory failed to have an analytic systems oversight through monthly QA
quality assessment mechanism that included a meetings, and will monitor
review of the effectiveness of HCG quality control compliance through its improved
corrective actions taken to resolve problems. occurrence management, and audit
Findings included: procedures.
lmmulite 2000 XPi instrument to perform and
report patient quantitative HCG test results. It
was also the practice of the laboratory to use
three levels of assayed quality control materials
and the stated values of the commercially
assayed quality control materials as the
laboratory's criteria for acceptability to monitor
patient quantitative HCG testing.
b. A review of the criteria for acceptability for the

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WBC differentials.
b. On August 23, 2015, in which the flow

cytometer was used to perform and report patient
WBC differentials, laboratory "Cytometer
Performance Reports" indicated that at 09:30 the
flow cytometer performance check failed. The
performance check was repeated and again
failed at 1O: 18. At 12:49, laboratory
documentation indicated that the flow cytometer
performance check passed.

to indicate that the actions taken on August 23,
2015 to "pass" the flow cytometer performance
check had been reviewed for the effectiveness of
the actions under the laboratory's quality
assessment mechanism.
D5793 #3
3. Based on technical supervisor interviews and The lab proactively paused testing on 2/12/16
human chorionic gonadotropin (HCG) quality
control record review on November 19, 2015, the
the Siemens Immulite 2000 XPi
laboratory failed to have an analytic systems during the survey.
review of the effectiveness of HCG quality control The lab has completed an assessment
corrective actions taken to resolve problems. to identify any patients affected or
Findings Included: having the potential to be affected by
a. It was the practice of the laboratory to use the this issue.
lmmulite 2000 XPI instrument to perform and
report patient quantitative HCG test results. It The new lab director is responsible for
was also the practice of the laboratory to use the lab's QA program and has
three levels of assayed quality control materials approved enhanced quality systems
and the stated values of the commercially and related procedures. The lab has
assayed quality control materials as the
laboratory's criteria for acceptability to monitor also appointed a Quality Director who
patient quantitative HCG testing. will provide additional oversight.

l:)V NOllVWtlOdNI dO WOG3ffi:Id HH.L "}13:GNfl ffiillSO'"DSIG WO"}ld .LdW8X3 NOllVWtlOdNI '1\i1;)"}13WW0;) '1VI.LN3GidN0;)
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three quality control materials (Bio-Rad, lot
05793
~~::: !~};~~~~~:~! reinforce the
number 40310, expiration date 12/31/2017) in need to document investigations and
use on November 19, 2015 indicated that for the the reasons for corrective action when
level 1 quality control material the criteria for QC fails to meet the lab's criteria for
acceptability used to monitor patient HCG testing acceptability, including the reasons for
was 9.38 - 14.4 mlU/mL, the level 2 quality any changes to QC parameters. The
control material's criteria for acceptability used to lab has conducted training on those
monitor patient HCG testing was 20.6 - 32.4
mlU/mL, and the level 3 quality control material's procedures.
criteria for acceptability used to monitor patient
HCG testing was 264 - 376. These procedures require the technical
supervisors to regularly review QC
c. According to the manufacturer's package and to initiate investigations and
insert, the assayed values of the three quality
control materials in use on November 19, 2015 to
corrective action when QC fails to
monitor patient HCG testing was 8.66 - 18.2 meet the lab's acceptability criteria. In
mlU/mL for level 1, 21.6 - 40.6 mlU/mL for level addition, oversight of QC reviews,
2, and 306 - 460 mlU/mL for level 3. investigations and corrective action
occurs through monthly QA meetings.
d. According to laboratory records, the criteria The lab will also monitor compliance
for acceptability for the three quality control
materials in use on November 19, 2015 to through its improved occurrence
monitor patient HCG testing was changed on management, and audit procedures.
September 11, 2015 to the criteria for
acceptability that was used until November 19, Before the lab resumes any test on the
2015. According to laboratory personnel, the Siemens Immulite 2000 XPi, the lab
change to the criteria for acceptability was made will ensure that the test has been
on September 11, 2015 because there was an
apparent "shift" in the laboratory's quality control re-verified pursuant to the lab's
materials test results. The laboratory conducted improved method verification
no further investigation or review prior to procedures that have been approved
changing the criteria for acceptability for the three by the new lab director. The lab will
quality control materials. also ensure that testing personnel have
been trained and demonstrated
e. The laboratory's change of the criteria for
acceptability for the two of the three HCG quality competency to ensure that practice is
control materials resulted in criteria for consistent with these procedures and
acceptability outside the criteria established by the other procedures for that test.
the manufacturer. The laboratory maintained no
l:)V NOllVffi!O.iNI dO WOQ3:ffild 3H.L 1:13:CINfl ffil11S0'1:)SIQ WO'&! .ldW3X3: NOI.LVffi!O.iNI '1VI:)1J:9Ji'JW0:) '1VI.LN3:Gii!N0:)
CONFIDENTIAL COMMERCIAL INFORMATION EXE:MPT FROM DISCLOSURE UNDER THE FREEDOM OF INFORMATION ACT
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REGULATORY OR LSC IDENTIFYING JNFORMATION) TAG CROSS-REFERENCED TO THE APPROPRIATE DATE
TAG
DEFICIENCY)

mechanism to assess the effectiveness of this
corrective action.
f. From September 11, 2015 to November 19,

2015, the laboratory performed and reported 19
patient quantitative HCG tests.
D5793 #4
4. Based on technical supervisor interviews and
hepatitis B survey antibody (HBsAb) quality The lab proactively paused testing on 2/12/16
control record review on November 19, 2015, the the Siemens Immulite 2000 XPi
laboratory failed to have an analytic systems during the survey. The lab has
quality assessment mechanism that included a completed an assessment to identify
review of the effectiveness of HBsAb quality any patients affected or having the
control corrective actions taken to resolve
potential to be affected by this issue.
. problems. Findings included:
a. It was the practice of the laboratory to use the The new lab director is responsible for
lmmulite 2000 XPi instrument to perform and the lab's QA program and has
report patient HBsAb test results. It was also the approved enhanced quality systems
practice of the laboratory to use three levels of and related procedures. The lab has
assayed quality control materials and the stated
values of the commercially assayed quality
control materials as the laboratory's criteria for will provide additional oversight.
acceptability to monitor patient HBsAb testing.
b. A review of the criteria for acceptability for the enhanced QC procedures to reinforce
three quality control materials (Siemens, lot the need to document investigations
number 0134, expiration date 11/2016) in use on
November 19, 2015 indicated that for the
and the reasons for corrective action
negative quality control material the criteria for when QC fails to meet the lab's
acceptability used to monitor patient HBsAb acceptability criteria, including the
testing was 0.0 - 4.0, the low positive quality reasons for any changes to QC
control material's criteria for acceptability used to parameters. The lab has conducted
monitor patient HBsAb testing was 10.3 - 19.6, training on those procedures.
and the positive quality control material's criteria
for acceptability used to monitor patient HBsAb
testing was 234 - 345. These procedures require the technical
c. According to the manufacturer's package

l:)V NOLLV1"IBO.iNI dO Ji\IOQ33}ld 3H.L 1!3CINfl ffililS01:>SIQ WOfil .Ld}'i[3X3 NOLLV1"IBOdNI 1VI:>1!3WWO:> 1VI.LN3GidNO:>
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05793 Continued From page 58 05793 supervisors
. to regul arl y review
. QC
and to initiate investigations and
monitor patient HBsAb testing was 0.0 - 4.0 for corrective action when QC fails to
the negative quality control material, 11 - 21 for meet the lab's acceptability criteria. In
the low positive quality control material, and 226 - addition, oversight of QC reviews,
340 for the positive quality control material. investigations and corrective action
occurs through monthly QA meetings.
d. According to laboratory records, the criteria
for acceptability for two of the three quality control The lab will also monitor compliance
materials in use on November 19, 2015 to through its improved occurrence
monitor patient HBsAb testing was changed on management, and audit procedures.
September 11, 2015 to the criteria for
acceptability that was used until November 19,
2015. According to laboratory personnel, the
change to the criteria for acceptability was made
on September 11, 2015 because there was an
apparent "shift" in the laboratory's quality control
materials test results. The laboratory conducted
no further investigation or review prior to
changing the criteria for acceptability for the three
quality control materials.

acceptability for the two of the three HBsAb
quality control materials resulted in criteria for
acceptability outside the criteria established by
corrective action.
f. From September 11, 2015 to November 19,

patient HBsAb tests.
5. Based on technical supervisor interviews and

luteinizing hormone {LH) quality control record
review on November 19, 2015, the laboratory
failed to have an analytic systems quality
assessment mechanism that included a review of
.L:::>V NOI.LVWNOdNI tlO Ji\IOGHffiltl illll 'MHCIN.fl ffilfl.SO'lJSIG Ji\IO'Mtl .Lc1Ji\I3XH NOI.LVWNOdNI 'IVI:J'MHJi\IJi\IO:J 'IVI.LNHGitlNO:J
PRINTED: 01/25/2016
'6?) STATEMENT OF DEFICIENCIES (X1) PROVIDER/SUPPLIER/CLIA (X2) MULTIPLE CONSTRUCTION (X3) DATE SURVEY
%HY AND PLAN OF CORRECTION IDENTIFICATION NUMBER: A. BUILDING _ _ _ _ _ _ __ COMPLETED
0502025714 B. WING _ _ _ _ _ _ _ __
11/20/2015
7333 GATEWAY BLVD
THERANOSINC
NEWARK, CA 94560
TAG TAG
DEFICIENCY)
D5793 #5 2/12/16
o5793 The lab proactively paused testing on
the effectiveness of LH quality control corrective
actions taken to resolve problems. Findings
the Siemens Advia Centaur XP
included: Immunoassay System during the
survey.
Siemens Advia Centaur XP Immunoassay The lab has completed an assessment
System instrument to perform and report patient to identify any patients affected or
LH test results. It was also the practice of the
laboratory to use three levels of assayed quality having the potential to be affected by
control materials and the stated values of the this issue.
commercially assayed quality control materials as
the laboratory's criteria for acceptability to monitor The new lab director is responsible for
patient LH testing. the lab's QA program and has
three quality control materials (Bio-Rad, lot and related procedures. The lab has
number 50980, expiration date 11/30/2016) in also appointed a Quality Director who
use on November 19, 2015 indicated that for the will provide additional oversight.
level 1 quality control material the criteria for
acceptability used to monitor patient LH testing These new procedure reinforce the
was 2.86 - 4.18 mlU/mL, the level 2 quality
control material's criteria for acceptability used to
need to document investigations and
monitor patient LH testing was 16.98 - 25.48 the reasons for corrective action when
mlU/mL, and the level 3 quality control material's QC fails to meet the lab's acceptability
criteria for acceptability used to monitor patient criteria, including the reasons for any
LH testing was 57.6 - 84.8 mlU/mL. changes to QC parameters. The lab
has conducted training on those
procedures.
monitor patient LH testing was 2.86 - 4.18 These procedures require the technical
mlU/mL for level 1, 16.6 - 23.9 mlU/mL for level supervisors to regularly review QC
2, and 57.6 - 84.8 mlU/mL for level 3. and to initiate investigations and
d. According to laboratory records, the criteria
for acceptability for one of the three quality control meet the lab's criteria for
materials in use on November 19, 2015 to acceptability. In addition, oversight of
monitor patient LH testing was changed on July 9, QC reviews, investigations and
2015 to the criteria for acceptability that was used corrective action occurs through
FORM CMS-2567(02-99) Previous Versions Obsolete Event ID:W34211 Facll!ty ID: CA22046272 If continuation sheet Page 60 of 121
1:)V NOI.LVJAIBO.iNI dO WOG3:ffild 3RL "M3:cINfl ffilflS01::)SIG WO"Mtl .I.dW3:X3: NOI.LVJAIBO.iNI 1VI::)"M3:WW0::) 1VI.LN3:GidN0::)
PRINTED: 01 /25/2016
0502025714 B. WING _ _ _ _ _ _ _ __
11/20/2015
7333 GATEWAY BLVD
THERANOSINC
NEWARK, CA 94560
TAG
DEFICIENCY)
D5793 #5
monthly QA meetings. The lab will
until November 19, 2015. According to laboratory
personnel, the change to the criteria for also monitor compliance through its
acceptability was made on July 9, 2015 because improved occurrence management and
there was an apparent "shift" in the laboratory's audit procedures.
quality control materials test results. The
laboratory conducted no further investigation or
review prior to changing the criteria for
acceptability for the three quality control
materials.

acceptability for the one of the three LH quality
control materials resulted in criteria for
acceptability outside the criteria established by
corrective action.
f. From July 9, 2015 to November 19, 2015, the

laboratory performed and reported 132 patient LH
tests.
6. Based on technical supervisor interviews and D5783 #6

CA-125 quality control record review on This finding appears to have a 2/12/16
November 19, 2015, the laboratory failed to have typographical error because CA-125
an analytic systems quality assessment was tested on the Siemens Advia
mechanism that included a review of the Centaur XP Immunoassay System
effectiveness of CA-125 quality control corrective
actions taken to resolve problems. Findings during this period, not the Siemens
included: Immulite 2000 XPi.
a. It was the practice of the laboratory to use the The lab proactively paused testing on
lmmulite 2000 XPi instrument to perform and the Siemens Advia Centaur XP
report patient CA-125 test results. It was also the Immunoassay System during the
practice of the laboratory to use three levels of
assayed quality control materials and the stated survey.
values of the commercially assayed quality
control materials as the laboratory's criteria for The lab has completed an assessment
acceptability to monitor patient CA-125 testing.
.L:)V NOLLVY'rnOdNI dO Ji\J:003:ffild fill "'i13:CINfl ffiillSO'l:)SIG WO"'ild l.dit\T3X3: NOilVY'rnOdNI '1VI::)"'il3J'®\I0::) '1VllN3:G.ldN0::)
PRINTED: 01/25/2016
DEPARTfylENT OF HEALTH AND HUMAN SERVICES FORM APPROVED
0502025714 B. WING _ _ _ _ _ _ _ __
11/20/2015
7333 GATEWAY BLVD
THERANOS INC
NEWARK, CA 94560
TAG TAG
DEFICIENCY)
05793 Continued From page 61 05793 to 1"dent1"fy any patients
. af~.1ecte d or
three quality control materials (Bio-Rad, lot this issue.
number 19980, expiration date 09/30/2016) in
use on November 19, 2015 indicated that for the The new lab director is responsible for
level 1 quality control material the criteria for the lab's QA program and has
acceptability used to monitor patient CA-125 approved enhanced quality systems
testing was 18.6 - 28.7 U/ml, the level 2 quality
control material's criteria for acceptability used to and related procedures. The lab has
monitor patient CA-125 testing was 53.5 - 82.2 also appointed a Quality Director who
U/ml, and the level 3 quality control material's will provide additional oversight.
criteria for acceptability used to monitor patient
CA-125 testing was 92.5 - 141 U/ml. The new lab director has approved
enhanced QC procedures to reinforce
insert for quality control materials Bio-Rad, lot the need to document investigations
number 19980, there were no assayed values for and the reasons for corrective action
the three quality control materials in use on when QC fails to meet the lab's
November 19, 2015 to monitor patient CA-125. acceptability criteria, including the
According to laboratory personnel, the quality reasons for any changes to QC
control material's manufacturer could not publish
the criteria for acceptability at the time the quality
parameters. The lab has conducted
control material was received by the laboratory, training on those procedures.
and was told by the manufacturer to use the
criteria for acceptability from the previous lot of These procedures require the technical
quality control materials. The laboratory supervisors to regularly review QC
maintained no documentation to support the and to initiate investigations and
manufacturer's instructions for the use of the
criteria for acceptability from the previous lot of
quality control materials. meet the lab's criteria for
acceptability. In addition, oversight of
d. A review of the manufacturer's criteria for QC reviews, investigations and
acceptability from the previous lot of CA-125 corrective action occurs through
quality control materials revealed that the criteria monthly QA meetings. The lab will
for acceptability for the quality control materials
used by the laboratory on November 19, 2015 to also monitor compliance through its
monitor patient CA-125 testing did not match the improved occurrence management,
criteria for acceptability from the previous lot of and audit procedures.
CA-125 quality control materials.
FORM CMS-2567(02-99) Previous Versions Obsolete Event ID:W34211 Facility ID: CA.22046272 If continuation sheet Page 62 of 121
l::)V NOI.l~OiINI tIO WOCT33"1:ItI 3H.L 'M3CINfl ffilflS01:::>Sia WO'Mtl ldW3X3 NOI.l~OOO 1VI:::>'M3WWO:::> 1VIlN3aitINO:::>
PRINTED: 01/25/2016
B. WING _ _ _ _ _ _ _ __
0502025714 11/20/2015
7333 GATEWAY BLVD
THERANOS INC
NEWARK, CA 94560
TAG TAG
DEFICIENCY)
e. Upon further review, it was discovered that

the criteria for acceptability for the quality control
materials used by the laboratory on November
19, 2015 to monitor patient CA-125 testing was
the criteria for acceptability established by the
manufacturer for Bio-Rad, lot number 19980, for
use on a different instrument and not the
Siemens Advia Centaur XP Immunoassay
System instrument.
f. From the date quality control materials

Bio-Rad, lot number 19980 to November 19,
patient CA-125 tests.
7. Based on laboratory personnel interviews and D5793 #7

the laboratory's "Alternative Assessment The lab directors during the period 2/12/ 16
Program" (AAP) record review on November 20, covered by the survey no longer hold
2015, the laboratory failed to have an analytic any position with the lab. The new lab
systems quality assessment mechanism that
included the timely review of the effectiveness of
director was hired after the on-site
actions taken. Findings included: survey had been completed.
a. To comply with the CUA requirement at 42 The new lab director is responsible for
C.F.R. 493.1281(a), the laboratory maintained a the lab's QA program and has
protocol titled "Proficiency Testing for Theranos approved enhanced quality systems
Lab-Developed Tests" that included a laboratory
process called AAP in which tests performed and related procedures. The lab has
using the b4 would be evaluated and also appointed a Quality Director who
defined in relationship to the Advia XPT. will provide additional oversight.
b. A review of laboratory documents indicated The new lab director has approved
that for the following AAP events, the laboratory's enhanced procedures requiring that
evaluation was not timely and, therefore,
ineffective: alternative assessments must be
subject to timely review and
i. On April 1, 2014, the laboratory completed
testing for 18 routine chemistry analytes using the
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PRINTED: 01/25/2016
&]\ STATEMENT OF DEFICIENCIES (X1) PROVIDER/SUPPLIER/CUA (X2) MULTIPLE CONSTRUCTION (X3) DATE SURVEY
\)fad) AND PLAN OF CORRECTION IDENTIFICATION NUMBER: A. BUILDING _ _ _ _ _ _ __ COMPLETED
0502025714 B.WING
11/20/2015
7333 GATEWAY BLVD
THERANOSINC
NEWARK, CA 94560
TAG
DEFICIENCY)
b4
o5793 evaluation by the lab director and/or a
and compared these test results to
test results on the same samples using the Advia
technical supervisor.
XPT. Laboratory records indicated that the
review of this MP was not completed until The lab will provide oversight through
November 16, 2015 by appropriate laboratory monthly QA meetings, and will also
personnel and was not reviewed by the laboratory monitor compliance through its
director as required by laboratory protocol. improved occurrence management and
ii. On May 15, 2014, the laboratory completed
audit procedures.
b4 and compared these test results to
review of this MP was not completed until
November 15, 2015 by appropriate laboratory
personnel.
iii. On July 31, 2014, the laboratory completed

b4 and compared these test results to
review of this MP was not completed until
November 16, 2015 by appropriate laboratory
personnel and was not reviewed by the laboratory
director as required by laboratory protocol.
iv. On November 20, 2014, the laboratory

completed testing for 14 routine chemistry
analytes using the b4 and compared
these test results to test results on the same
samples using the Advia XPT. Laboratory
records indicated that the review of this MP was
not completed until November 15, 2015 by
appropriate laboratory personnel.
8. Based on review of the quality control (QC) 2/12/16

procedure, Levey-Jennings reports for the Advia
1800 and Advia XPT, proficiency testing (PT)
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CONFIDENTIAL COMJ\1ERCIAL INFORMATION EXEMPT FROM DISCLOSURE UNDER THE FREEDOM OF INFORMATION ACT
PRINTED: 01/25/2016
tf?f::}. STATEMENT OF DEFICIENCIES (X1) PROVIDER/SUPPLIER/CUA (X2) MULTIPLE CONSTRUCTION (X3) DATE SURVEY
~MID AND PLAN OF CORRECTION IDENTIFICATION NUMBER: A. BUILDING _ _ _ _ _ _ __ COMPLETED
0502025714 B. WING _ _ _ _ _ _ _ __
11 /20/2015 ·
7333 GATEWAY BLVD
THERANOSINC
NEWARK, CA 94560
{X4) ID SUMMARY STATEMENT OF DEFICIENCIES ID PROVIDER'S PLAN OF CORRECTION (XS)
TAG
DEFICIENCY)
D5793 #8
results and quality assessment (QA)
o5793 The lab has completed an assessment
documentation the laboratory failed to take to identify any patients affected or
corrective actions when chemistry QC in the having the potential to be affected by
venipuncture laboratory was observed ten this issue.
consecutive times on the same side of the mean.
Findings include: The new lab director is responsible for
a, CL QOP-00013 Revision D, "Quality Control
in Chemistry", stated in section 6.3.1. 7.2 that QC approved enhanced quality systems
is deemed to have passed when ... Westgard rules and related procedures. The lab has
hae not been violated (see following monthly QC also appointed a Quality Director who
section 6.3.2)." will provide additional oversight.
b. CL QOP-00013 Revision D also stated in
section 6.3.2.5 that ten consecutive observations
on the same side of the mean should be enhanced QC procedures to reinforce
monitored. that regular review of QC data is
required and that investigations and
c. The Advia XPT was put into use for chemistry corrective actions must be taken when
testing on 12/18/14. Prior to 12/18/14, the Advia QC fails to meet the lab's criteria for
1800 was used for chemistry testing.
acceptability. The lab has conducted
Albumin training on those procedures to ensure
that practice is consistent w1th them.
i. Review of the PT results for albumin for the
1st and 2nd events of 2015 revealed that the These procedures require the technical
submitted results showed a negative bias ranging supervisors to regularly review QC
from -3.3 to -4.9 and -1.8 to -3.5, respectively.
and to initiate investigations and
ii. Review of Levey-Jenning reports from April corrective action when QC fails to
2014 and September 2014, revealed that meet the lab's criteria for
MultiQual Level 1 (MQ1) and Multi Qual Level 2 acceptability. In addition, oversight of
(MQ2) had at least 10 consecutive results below QC reviews, investigations and
the mean but within 2 standard deviations (SD). corrective action occurs through
iii. Review of Levey-Jenning reports for January monthly QA meetings. The lab will
2015 through April 2015 revealed MQ1 (Lot also monitor compliance through its
number 45661) had 1O consecutive results below improved occurrence management,
the mean, MQ2 (Lot number 45662) had 10 and audit procedures.
FORM CMS-2567(02-99) Previous Versions Obsolete Event ID:W34211 Facility ID: CA22046272 If continuation· sheet Page 65 of 121
.1:)V NOI.lVW}IO!INI !IO WOOHffiltl filll 1IHONC1 ffilflSO'I::>SIO W01Itl .ldWHXH NOI.LVW}IOtlNI 'IVC:)1!8:WWO;) 'IVI.LNHOI.!INO;)
PRINTED: 01/25/2016
0502025714 B. WING _ _ _ _ _ _ _ __
11/20/2015.
7333 GATEWAY BLVD
THERANOS INC
NEWARK, CA 94560
DEFICIENCY)
(continued; see above)

consecutive results below the mean and
MultiQual Level3 (MQ3, Lot number 45663) had
10 consecutive results below the mean but within
2 SDs for all four months.
iv. MQ1 data revealed 125 of 125 below the

mean for January 2015 through April 2015 but
within 2 SDs.
v. MQ2 data revealed 126 of 126 below the

within 2 SDs.
vi. MQ3 data revealed 123 of 125 below the

within 2 SDs.
vii. Review of Levey-Jenning reports from May

2015 revealed that MQ1 ,· MQ2 and MQ3 were
below the mean for 21 of 31 days.
viii. The mean for aH three levels was adjusted on

5/22115 to fit the data without investigation or
documentation of an investigation. After 5/22/15
all 3 levels of QC were above the mean.
ix. The manufacturer ranges for MQ1 {Lot

number 45661) was 2.03-3.04 gldL; MQ2 (Lot
number 45662) was 3.04-4.56 g/dL; MQ3 (Lot
number 45663) was 3.26-4.89 g/dl.
x. After adjusting the acceptable ranges on

5122/15, the laboratory's ranges fell outside the
manufacturer's assayed ranges and were as
follows: MQ1 (1.77-2.665 g/dL); MQ2 (2.5-3.74
g/dL; MQ3 (3.02-4.52 g/dL).
xi. Quarterly Quality Assessment PowerPoint

presentations from the 3rd quarter of 2014
.1::)V NOI.LVJi'IBO.dNI .m woaaffili fill 118:CINfl ffiIDSO'I:::>Sia wmw: .La:waxa NOI.LVJi'IBOdNI '1VI:::>1IHWWO:::> '1VI.LN8:CII.!:INO:::>
PRINTED: 01/25/2016
STATEMENT OF DEFICIENCIES (X1} PROVIDER/SUPPLIER/CLIA (X2) MULTIPLE CONSTRUCTION (X3) DATE SURVEY
AND PLAN OF CORRECTION IDENTIFICATION NUMBER; A. BUILDING _ _ _ _ _ _ __ COMPLETED
0502025714 B. WING _ _ _ _ _ _ _ __
11/20/2015 .
7333 GATEWAY BLVD
THERANOS INC
NEWARK, CA 94560
(X4}1D SUMMARY STATEMENT OF DEFICIENCIES ID PROVIDER'S PLAN OF CORRECTION (X5)
TAG TAG
DEFICIENCY)
( continued; see above)

through the 2nd quarter of 2015 did not identify
the negative bias for albumin or the 1O
consecutive QC values above or below the mean.
xii. 8293 albumins were reported from January

2015 through June 2015.
Calcium
i. Review of the PT results for calcium for the

2nd events of 2015 revealed that the submitted
results showed a negative bias ranging from -3.9
to -5.1.
ii. Review of Levey-Jenning reports from April

2014 and May 2015 revealed 27 of27 and 25 of
25 QC consecutive results below the mean but
within 2 SDs.
iii. 7719 calciums were reported from January

2015 through June 2015.
other Chemistries
Review of Levey-Jenning reports from April 2014,

September 2014, and January 2014 revealed that
Creatinine, Glucose, High density lipoprotein
(HDL), Low density lipoprotein (LDL), Total
Bilirubin, Chloride, Potassium, Triglycerides,
Cholesterol, Alkaline Phosphatase, and Alanine
Transaminase had at least one event of 1O
consecutive QC results above or below the mean
but within 2 SDs for one to 3 levels of QC.
9. Based on review of the alternative

assessment procedure (AAP) and results of AAP
from August 2014 through March 2015, the
laboratory failed to identify through the quality
assessment (QA) activities that the AAP for the
FORM CMS-2567(02-99} Previous Versions Obsolete Event ID: W34211 Facility ID; CA22046272 If continuation sheet Page 67 of 121
J.:J\f NOIJ.Vli'IBQtlN[ i[Q woamr&I HH.L 1:IHCINfl ffiiflSO'J::)SIO W01Itl J.cil'\IHXH NOIJ.VW1IOtlNI 'I\fI::)1:IfilillWO::) 'I\fIJ.NHartlNO::)
PRINTED: 01/25/2016
fJ)C STATEMENT OF DEFICIENCIES (X1) PROVIDER/SUPPLIER/CUA (X2) MULTIPLE CONSTRUCTION (X3) DATE SURVEY
1(£): AND PLAN OF CORRECTION IDENTIFICATION NUMBER: A. BUILDING _ _ _ _ _ _ __ COMPLETED
0502025714 B.WING
11/20/2015
7333 GATEWAY BLVD
THERANOSINC
NEWARK, CA 94560
TAG TAG
DEFICIENCY)
D5793 #9 2/12/16
The lab directors during the period
Theranos Propietary System (TPS) was not
covered by the survey no longer hold
performed every 6 months and was not reviewed
and reviewed and approved by the laboratory any position with the lab. The new lab
(LD) in a timely manner as required by the director was hired after the on-site
laboratory's procedures, and therefore, survey had been completed.
ineffective. Findings include:
a. CL SOP-00020 Revision B, "Proficiency
testing for Theranos Lab-Developed Tests the lab's QA program. The lab has
(lmmunoassays)", effective 1/1/2014, stated in also appointed a Quality Director who
section 3.1 that the technical supervisor (TS) was will provide additional oversight.
responsible for ensuring that the AAP was
conducted every 6 months for all analytes. The new lab director has approved
enhanced quality systems to ensure
b. Section 3.3.2 of the procedures stated that
the TS was reponsible for evaluating testing that the lab's procedures are followed.
samples results and section 3.4 stated that the Among other things, the lab's
LD was responsible for reviewing and approving management, including the new lab
each testing event documentation. director and new quality systems
director, will provide oversight over
c. Review of the AAP result forms (CL
proficiency testing and AAP through
FRM-00022-F3) revealed that the AAP was
performed on 8/18/14, 10/21 /14, and 3/13/15. monthly QA meetings. The lab will
also monitor compliance through its
d. All three result forms did not include a improved occurrence management,
documented evaluation by the TS. and audit procedures.
e. The result documents from 8/18/14 and

Before the survey, the lab proactively
3/15/15 were not signed by the LD until 11 /15/15
and the result form from 10/12/14 was not signed paused testing on its laboratory
by the LD. developed tests. It is not currently
performing AAP testing.
f. Four tests (Vitamin D, Thyroid Stimulating
Hormone, Free T4, and Total Prostate Specific
Antigen) were initially implemented in November
2013.
10. Based on review of patient raw data reports

and the validation report for Vitamin D (Vito), the
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PRINTED: 01/25/2016
tK?> STATEMENT OF DEFICIENCIES (X1) PROVIDER/SUPPLIER/CLIA (X2) MULTIPLE CONSTRUCTION (X3) DATE SURVEY
\}f/ AND PLAN OF CORRECTION IDENTIFICATION NUMBER: A. BUILDING _ _ _ _ _ _ __ COMPLETED
0502025714 B. WING _ _ _ _ _ _ _ __
11/20/2015 .
7333 GATEWAY BLVD
THERANOSINC
NEWARK, CA 94560
(X4) ID SUMMARY STATEMENT.OF DEFICIENCIES ID PROVIDER'S PLAN OF CORRECTION (XS)
TAG TAG
DEFICIENCY)

laboratory failed to have a quality assessement
mechanism to identify that the laboratory's
reference ranges established from the validation
study were accurately reflected on the patient raw
data reports. Findings include:
a. The validation report for VitD stated that the

reference range was 9.3-47.9 ng/ml.
b. The patient raw data reports revealed that the

reference range was "30-100."
c. Patient raw data reports were reviewed from

6/15/14 through 8/31/14 and from 2/1/15 through
2/17/15.
d. Thirty (30) of ninety-four (94) patient results

were flagged as "Insufficiency" on the patient raw
data report when the result was normal according
to the laboratory's reference range.
e. Twenty seven (27) of ninety four (94) patient

results were flagged as normal on the patient raw
data report when the result was above the normal
range according to the laboratory's reference
range.
05801 493.1291 (a) TEST REPORT 05801 D5801 2/12/16
The laboratory must have an adequate manual or
electronic system(s) in place to ensure test to identify any patients affected or
results and other patient-specific data are having the potential to be affected by
accurately and reliably sent from the point of data this issue.
entry (whether interfaced or entered manually) to
final report destination, in a timely manner. This The new lab director is responsible for
includes the following:
(a)(1) Results reported from calculated data.
(a)(2) Results and patient-specific data approved enhanced quality systems
electronically reported to network or interfaced and related procedures. The lab has
.L;)V NOI.LYmOtlNI .!IO woaa:'tnLI HHL 118:CINfl ffil.O.SO'I::)SIQ WOlfiI .LdWHXH NOI.LYmOdNI 'IV[;)1J:3WW0;) 'NI.LNHaidNQ;)
PRINTED: 01/25/2016
0502025714 B.WING 11/20/2015 .

7333 GATEWAY BLVD
THERANOSINC
NEWARK, CA 94560
TAG TAG
DEFICIENCY)

D5801 (continued):
laboratory failed to have a quality assessement
mechanism to identify that the laboratory's
reference ranges established from the validation will provide additional oversight.
study were accurately reflected on the patient raw
data reports. Findings include: The new lab director has approved
enhanced procedures for reagent
a. The validation report for Vito stated that the qualification and management that
reference range was 9.3-47.9 ng/ml.
include procedures to ensure
b. The patient raw data reports revealed that the manufacturer inserts are reviewed.
reference range was "30-100." Training on these procedures has
occurred.
c. Patient raw data reports were reviewed from
6/15/14 through 8/31/14 and from 2/1/15 through
2/17/15.
Before PT/INR testing resumes, the
lab will also prepare a revised
d. Thirty (30) of ninety-four (94) patient results assay-specific procedure for PT/INR
were flagged as "Insufficiency" on the patient raw to reinforce that the International
data report when the result was normal according Normalized Ratio (INR) must be
to the laboratory's reference range. calculated accurately prior to reporting
e. Twenty seven (27) of ninety four (94) patient
patient test results. The relevant
results were flagged as normal on the patient raw testing personnel will be required to
data report when the result was above the normal demonstrate competency to ensure
range according to the laboratory's reference that practice is consistent with these
range. procedures.
05801 493.1291 (a) TEST REPORT 05801
The lab will provide oversight through
The laboratory must have an adequate manual or
electronic system(s) in place to ensure test monthly QA meetings, and will also
results and other patient-specific data are monitor compliance through its
accurately and reliably sent from the point of data improved occurrence management,
entry (whether interfaced or entered manually) to and audit procedures.
final report destination, in a timely manner. This
includes the following:
(a)(1) Results reported from calculated data.
(a)(2) Results and patient-specific data
electronically reported to network or interfaced
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0502025714 B. WING _ _ _ _ _ _ _ __
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{X4) ID SUMMARY STATEMENT OF DEFICIENCIES ID PROVIDER'S PLAN OF CORRECTION (X5)
PREFIX {EACH DEFICIENCY MUST BE PRECEDED BY FULL PREFIX (EACH CORRECTIVE ACTION SHOULD BE COMPLETION
TAG TAG
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systems.
(a)(3) Manually transcribed or electronically
transmitted results and patient-specific
information reported directly or upon receipt from
outside referral laboratories, satellite or
point-of-care testing locations.
Based on review of the patient results,
manufacturer International Sensitivity Index (ISi)
number, and the laboratory's mean normal
prothrombin time (MNPT), the laboratory failed to
ensure that the reported International Normalized
Ratio (INR) was calculated accurately prior to
reporting final patient test results. Findings
include:
a. Laboratory quality control records revealed

that Dade lnnovin (throm.boplastin) lot number
539280 was put into use in March 2015. The
MNPT for this lot number was determined to be
8.0 seconds and the manufacturer stated that the
ISi was 0.89.
b. A review of the INR results from 4/3/15

through 9/21/15 revealed that 81 of 81 reported
final patient results were not accurate when the
patient prothrombin time {PT) was used with the
above MNPT and ISi numbers to calculate the
INR.
c. The final reported results varied from the true

results by 0. 1-0.5 units.
05805 493.1291(c) TEST REPORT 05805 D5805: 2/12/16
The lab revised its patient reports for
The test report must indicate the following: PT/INR during the survey so that the
(c)(1) For positive patient identification, either the
patient's name and identification number, or a interpretive note appears only under
unique patient identifier and identification number. the heading for patients with therapy.
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D5805 (continued):
(c)(2) The name and address of the laboratory
location where the test was performed.
(c)(3) The test report date. having the potential to be affected by
(c)(4) The test performed. this issue.
(c)(5) Specimen source, when appropriate.
(c)(6) The test result and, if applicable, the units The new lab director has approved
of measurement or interpretation, or both. enhanced reporting procedures that
(c)(7) Any information regarding the condition and
disposition of specimens that do not meet the require the technical supervisor to
laboratory's criteria for acceptability. verify that interpretive information is
This STANDARD is not met as evidenced by: accurate and to obtain approval from
Based on review of final reports and interview the lab director or clinical consultant
with the Senior Vice President, the laboratory before any updates are implemented.
failed to differentiate the intrepretive data for
Warfarin therapy vs. Non-Warfarin Therapy.
Findings include: The lab will provide oversight through
monthly QA meetings, and will also
a. Thirteen of thirteen final patient test reports monitor compliance through its
reviewed indicated that the International improved occurrence management,
Normalized Ratio (INR) interpretive data on the and audit procedures.
final report was identical for Warfarin therapy and
non-Warfarin therapy.
b. The Senior Vice President confirmed the

above finding on 9/22/15 at approximately 4:45
pm.
05821 493.1291 (k) TEST REPORT 05821 D5821: 2/12/16
When errors in the reported patient test results
are detected, the laboratory must do the enhanced procedures to address
following: correcting potential errors in patient
(k)(1) Promptly notify the authorized person reports. These procedures require that
ordering the test and, if applicable, the individual the person ordering the test is
using the test results of reporting errors. promptly notified after the lab
(k)(2) Issue corrected reports promptly to the
determines that a correction is
authorized person ordering the test and, if
applicable, the individual using the test results. required.
(k)(3) Maintain duplicates of the original report, as
.L::>V NOI.LYW.110.!INI .!IO woaa:ffiid: ffi:LL 113:CIND. ffililSO'I:JSia W01Id: .LcIWa:xa: NOI.LVJIIIBOdNI 'IVI;)1Iffiillli\!0;) 'IVI.LN3:GHN0;)
CONFIDENTIAL COMMERCIAL INFORMATION EXE:tv!PT FROM DISCLOSURE UNDER THE FREEDOM OF INFORMATION ACT
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D5821 (continued):
05821
well as the corrected report.
Based on review of patient test reports and having the potential to be affected by
interview with the technical supervisor, the this issue.
laboratory failed to notify the authorized person
for approximately seven weeks after the surveyor The lab will provide oversight through
identified a quality control problem with
monthly QA meetings, and will also
Prothrombin Time/International Normalized Ratio
(PT/INR). Findings include: monitor compliance through its
improved occurrence management and
a. Refer to 06093. audit procedures.
b. Five of thirteen final patient reports reviewed

showed corrected reports were faxed between
11/11/15 and 11/15/15.
c. Eight of thirteen final patient reports reviewed

did not show documentation that the authroized
person was notified when an error in patient test
results was detected.
d. 81 PT/INR patient test results were reported

from 4/1/15 through 9/16/15.
e. The technical supervisor stated that all

authorized persons were notified of the error in
PT/INR results, including those without
documentation.
D6076: 2/12/16
06076 493.1441 LABORATORY DIRECTOR 06076
The laboratory has completed
The laboratory must have a director who meets assessments to identify any patients
the qualification requirements of §493.1443 of affected or having the potential to be
this subpart and provides overall management affected by the issues identified in this
and direction in accordance with §493.1445 of observation, and has taken corrective
this subpart.
and preventative action. Among other
This CONDITION is not met as evidenced by: things, the lab has hired a new lab
Based on the number and severity of the
FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: W34211 Faclllty ID: CA22046272 If continuation sheet Page 72 of 121
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D607 6 (continued)
Laboratories performing high complexity testing; director and established improved
laboratory director was not met. The laboratory quality systems and related procedures
director failed to ensure that appropriate addressing the issues identified in this
personnel were responsible for the quality control observation. (D6079, D6083, D6085,
(QC) and quality assessment (QA) programs (see D6086, D6093, D6094, D6102).
06079); failed to ensure that the freezer
temperatures were appropriate for storage of
specimens and reference materials (see 06083);
failed to ensure the methodologies selected
provided quality results (see 06085); failed to
ensure the verification procedures were adequate
(see 06086); failed to ensure that the QC
programs (see 06093) and QA programs (see
06094) are established and maintained; failed to
ensure that the final patient test reports included
appropriate interpretation information for PT/INR
(see 06098); and failed to ensure that all
personnel were appropriately trained (see
06102). D6079
06079 493.1445(a)(b) LABORATORY DIRECTOR
RESPONSIBILITIES
o5o79 The lab directors during the period 2/12/16
The laboratory director is responsible for the any position with the lab. The new
overall operation and administration of the lab director was hired after the on-site
laboratory, including the employment of personnel survey had been completed.
who are competent to perform test procedures,
record and report test results promptly, accurately
and proficiently, and for assuring compliance with
the applicable regulations. to identify any patients affected or
(a) The laboratory director, if qualified, may having the potential to be affected by
perform the duties of the technical supervisor, this issue.
clinical consultant, general supervisor, and testing
personnel, or delegate these responsibilities to The new lab director is responsible for
personnel meeting the qualifications under
493.1447, 493.1453, 493.1459, and 493.1487
respectively. approved enhanced quality systems
(b) If the laboratory director reapportions and related procedures, including
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D6079 (continued)
o5o79 revised QC procedures to ensure the
performance of his or her responsibilities, he or
appropriate supervisors are involved
she remains responsible for ensuring that all
duties are properly performed. in review of quality metrics. The lab
This STANDARD is not met as evidenced by: has conducted training on those
Based on the Plan of Correction (POC) from the procedures. The new lab director is
12/3/2013 recertification survey and review of the technical supervisor for chemistry,
quality control (QC) and quality assessment (QA) hematology, and immunohematology.
documentation and the Laboratory Personnel
Report (CMS-209), the laboratory director (LO) During the survey, CMS determined
failed to ensure that the laboratory's QC and QA that Technical Supervisor #3 was
programs were delegated to a qualified technical qualified in bacteriology, mycology,
supervisor (TS). Findings include: virology, and diagnostic immunology.
These technical supervisors are now
a. The POC from the laboratory's 12/3/2013 responsible for QC assessments in
recertification survey stated that a QA/QC
Manager Wal:! hired and began employment on their respective specialties.
12/10/13.
The lab will ensure that the new lab
b. The QA/QC Manager stated on 9/23/15 and director is effective in overseeing
again on 11/19/15 that evaluating and monitoring compliance with these procedures
the QA and QC programs was solely the QA/QC
through audits performed pursuant to
Manager's responsibility.
the lab's new audit procedures,
c. The QA/QC Manager was not listed on the through oversight during monthly QA
CMS-209 forms dated 9/19/15, 9/23/15, or meetings, and through use of a new
11 /15/15 in any capacity. on-site visit log that records the lab
director's time spent physically in the
d. The QA/QC Manager was not qualified to
oversee and maintain the QC and QA programs. lab.
06083 493.1445(e)(2) LABORATORY DIRECTOR 06083
RESPONSIBILITIES D6083 2/12/16
The laboratory director must ensure that the covered by the survey no longer hold
physical plant and environmental conditions of the any position with the lab. The new
laboratory are appropriate for the testing
lab director was hired after the on-site
performed.
This STANDARD is not met as evidenced by: survey had been completed.
Based on review of temperature documentation
.L:JV NOI.LVli'fl!O.iINI iIO WOCTHffiiiI ffilL 118:CINO. ITTID.SO'I:JSICT W01IiI .LdWHXH NOI.LVJi'fl!O.iINI 'JVI:)118:WWO:J 'IVI.LNHCIIiINO:J
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and interview with the Director of Assay Systems,
06083 ~~~!f
e~~~~::1; data demonstrated
the laboratory director failed to ensure that the
freezer temperatures were appropriate for nearly all of the freezers at issue met
storage of reference materials and patient the manufacturer temperature
specimens. Refer to 05413 and 05791. requirements for the materials stored.
06085 493.1445(e)(3) LABORATORY DIRECTOR 06085 The lab has identified and discarded
RESPONSI Bl LITI ES any materials that had the potential to
The laboratory director must ensure that the test
have been affected. The lab has also
methodologies selected have the capability of completed an assessment to identify
providing the quality of results required for patient any patients affected or having the
care. potential to be affected by this issue.
Based on review of validation documents on the The lab will ensure that the new lab
Theranos Proprietary System (TPS), the
laboratory director failed to ensure that the quality director effectively implements and
of results on the TPS; failed to ensure the monitors lab procedures, including
establishment of performance specifications temperature management procedures,
followed the laboratory's procedures to establish through oversight during monthly QA
accuracy, precision, reportable range, and/or meetings, through audits performed
reference range. Findings include: pursuant to the lab's new audit
a. Validations Reports for Vitamin D (VitD), Total procedures, and through use of a new
T3 (TT3), Human Chorionic Gonadotropin (HCG), on-site visit log that records.the lab
and Sex Hormone Binding Globulin (SHBG) were director's time spent physically in the
reviewed. lab.
b. The laboratory presented the procedure, CL This improved oversight will ensure
PLN-14003 Revision A, "Master Validation Plan
for Routine Chemistry Assays on Theranos that the new lab director implements
Devices", when the surveyor requested their the lab's enhanced temperature
procedure for establishing performance management procedures, which
specifications. reinforce the proper monitoring of
temperature and environmental
c. VitD, HCG, and SHBG validation reports
conditions and the storage of materials
Included "Theranos-corrected" results without an
explanation as to how the "Theranos Result" was according to the manufacturer's
corrected or which result was reported. temperature range.
FORM CMS-2567(02-99) Previous Versions Obsolete Event ID:W34211 Faclllty ID: CA22046272 If continuation- sheet Page 75 of 121
J.:JV NOIJ.VJAraO.!:INI tlO WOO:Iffihl :IHJ. 1!:ICINf1 ffiI.O.SO'I::)SIO W01Itl J.dW8X:I NOIJ.VJAraOdNI 'IVJ::)1£:IWWQ::) 'IVIJ.N:ICITtlNO:::>
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D6083 (continued)
The lab has conducted training on
and interview with the Director of Assay Systems,
the laboratory director failed to ensure that the
those procedures
freezer temperatures were appropriate for
storage of reference materials and patient
specimens. Refer to 05413 and 05791. D6085 2/12/16
06085 493.1445(e)(3) LABORATORY DIRECTOR 06085 The lab directors during the period
RESPONSI Bl LIT! ES covered by the survey no longer hold
any position with the lab. The new lab
The laboratory director must ensure that the test
methodologies selected have the capability of director was hired after the on-site
providing the quality of results required for patient survey had been completed.
care.
This STANDARD is not met as evidenced by: The lab has completed an assessment
Based on review of validation documents on the to identify any patients affected or
Theranos Proprietary System (TPS), the
laboratory director failed to ensure that the quality
of results on the TPS; failed to ensure the this issue.
establishment of performance specifications
followed the laboratory's procedures to establish The lab will ensure that the new lab
accuracy, precision, reportable range, and/or director effectively implements and
reference range. Findings include: monitors lab procedures, including
a. Validations Reports for Vitamin D (VitD), Total verification and validation procedures,
T3 (TT3), Human Chorionic Gonadotropin (HCG), through oversight during monthly QA
and Sex Hormone Binding Globulin (SHBG) were meetings, through audits performed
reviewed. pursuant to the lab's new audit
procedures, and through use of a new
b. The laboratory presented the procedure, CL on-site visit log that records the lab
for Routine Chemistry Assays on Theranos director's time spent physically in the
Devices", when the surveyor requested their lab.
procedure for establishing performance
specifications. This improved oversight will ensure
that the new lab director implements
c. VitD, HCG, and SHBG validation reports
the lab's enhanced procedures for
included "Theranos-corrected" results without an
explanation as to how the "Theranos Result" was method verification. Before any
corrected or which result was reported.
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CENTERS FOR MEDICARE & MEDICAID SERVICE:S OMB NO 0938-0391
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TAG
DEFICIENCY)
D6085 (continued)
06085 Continued From page 75 . stud'1es are per1orme
06085 ven'fi1cat10n -C'. d,
d. Accuracy for Vito, TT3, HCG, and SHBG was these improved procedures require the
not determined following CL PLN-14003. lab director's review and approval of a
detailed method verification plan
e. Precision for VitD, TT3, and SHBG was not containing defined acceptance criteria.
determined following CL PLN-14003. The lab director must also review and
approve the verification report before
f. Reportable range data for VitD, TT3, and
SHBG was not determined following CL any patient testing begins. The lab has
PLN-14003. conducted training on those
procedures.
g. Percent(%) Recovery did not meet the
laboratory's accetable criteria for Vito, TT3, and The lab will ensure that the new lab
SHBG.
director also implements enhanced
h. Allowable· Bias did not meet the laboratory's validation procedures, which will
acceptable criteria for Vito, TT3, and SHBG. include review processes and
acceptance criteria similar to the
i. Refer to 06115. improved method verification
06086 493.1445(e)(3)(ii) LABORATORY DIRECTOR 06086 procedures, along with other required
RESPONSIBILITIES procedures. Relevant lab personnel
The laboratory director must ensure that will receive training and competency
verification procedures used are adequate to on those procedures to ensure that
determine the accuracy, precision, and other practice is consistent with them.
pertinent performance characteristics of the
method.
1. Based on laboratory personnel interview and
establishment of vitamin 812 performance
specifications record review on September 22,
2015, the laboratory director failed to ensure that
verification procedures used were adequate to
determine pertinent performance characteristics
for the laboratory's vitamin 812 testing methods.
Findings included:
a. A review of the laboratory's vitamin 812
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d. Accuracy for Vito, TI3, HCG, and SHBG was

not determined following CL PLN-14003.
e. Precision for Vito, TT3, and SHBG was not

determined following CL PLN-14003.
f. Reportable range data for Vito, TT3, and

SHBG was not determined following CL
PLN-14003.
g. Percent(%) Recovery did not meet the

laboratory's accetable criteria for Vito, TT3, and
SHBG.
h. Allowable. Bias did not meet the laboratory's

acceptable criteria for Vito, TT3, and SHBG.
i. Refer to 06115.
06086 493.1445(e)(3)(ii) LABORATORY DIRECTOR 06086 D6086 #1 2/12/16
RESPONSIBILITIES The lab directors during the period
The laboratory director must ensure that covered by the survey no longer hold
verification procedures used are adequate to any position with the lab. The new
determine the accuracy, precision, and other lab director was hired after the on-site
pertinent performance characteristics of the survey had been completed.
method.
1. Based on laboratory personnel interview and
establishment of vitamin 812 performance to identify any patients affected or
specifications record review on September 22, having the potential to be affected by
2015, the laboratory director failed to ensure that this issue.
verification procedures used were adequate to
determine pertinent performance characteristics
for the laboratory's vitamin 812 testing methods.
Findings included:
a. A review of the laboratory's vitamin 812
FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: W34211 Facility ID: CA22046272 If continuation· sheet Page 76 of 121
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AF?'\ STATEMENT OF DEFICIENCIES (X1) PROVIDER/SUPPLIER/CUA (X2) MULTIPLE CONSTRUCTION (X3) DATE SURVEY
\@j} AND PLAN OF CORRECTION IDENTIFICATION NUMBER: A. BUILDING _ _ _ _ _ _ __ COMPLETED
0502025714 B. WING _ _ _ _ _ _ _ __
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NEWARK, CA 94560
REGULATORY OR LSC IDENTIFYING INFORMATION) CROSS-REFERENCED TO THE APPROPRIATE OATE
TAG TAG
DEFICIENCY)
document indicated that the laboratory obtained
director effectively implements and
an allowable bias greater than the laboratory's monitors lab procedures, including
criteria for acceptability. When asked to explain verification and validation procedures,
this discrepant result, upon close examination, through oversight during monthly QA
laboratory personnel indicated that there was an meetings, through audits performed
error in the written information provided and pursuant to the lab's new audit
reviewed. The laboratory was able to provided
corrected data and appropriate supporting procedures, and through use of a new
documents. on-site visit log that records the lab
b. In spite of the erroneous information included lab.
in the vitamin 812 establishment of performance
specifications document provided during this
This improved oversight will ensure
survey for review on September 22, 2015,
laboratory records indicated that eleven people that the new lab director implements
from the laboratory's staff approved this the lab's enhanced procedures for
document between August 5, 2014 and method verification. Before any
September 19, 2015 without recognizing the verification studies are performed,
document error. these improved procedures require the
lab director's review and approval of a
establishment of performance specifications detailed method verification plan
policies and procedures record review on containing defined acceptance criteria.
September 22, 2015, the laboratory director failed The lab director must also review and
to ensure that verification procedures used are approve the verification report before
adequate to determine the accuracy, precision, any patient testing begins. The lab has
and other pertinent performance characteristics
of the laboratory's b4 testing methods. conducted training on those
Findings included: procedures.
a. It was the practice of the laboratory to use the The lab will ensure that the new lab
b4 to perform and report patient director also implements enhanced
routine chemistry serum testing. Examples of validation procedures, which will
analytes the laboratory tested using the b 4
b 4 included ALT, BUN, calcium, glucose, and
include review processes and
sodium. acceptance criteria similar to the
improved method verification
b. According to the laboratory's protocol titled
FORM CMS-2667(02-99) Previous Versions Obsolete Event ID:W34211 Facility ID: CA22046272 If continuation 'sheet Page 77 of 121
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{fa:\ STATEMENT OF DEFICIENCIES (X1) PROVIDER/SUPPLIER/CUA (X2) MULTIPLE CONSTRUCTION (X3) DATE SURVEY
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TAG TAG
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document indicated that the laboratory obtained
procedures, along with the other
an allowable bias greater than the laboratory's required procedures. Relevant lab
criteria for acceptability. When asked to explain personnel will receive training and
this discrepant result, upon close examination, competency on those procedures to
laboratory personnel indicated that there was an ensure that practice is consistent with
error in the written information provided and them.
reviewed. The laboratory was able to provided
corrected data and appropriate supporting
documents.
b. In spite of the erroneous information included

in the vitamin 812 establishment of performance
specifications document provided during this
survey for review on September 22, 2015,
laboratory records indicated that eleven people
from the laboratory's staff approved this
document between August 5, 2014 and
September 19, 2015 without recognizing the
document error.

establishment of performance specifications D6086 #2
policies and procedures record review on The lab directors during the period
September 22, 2015, the laboratory director failed covered by the survey no longer hold
to ensure that verification procedures used are any position with the lab. The new
adequate to determine the accuracy, precision, lab director was hired after the on-site
of the laboratory's b4 testing methods.
Findings included:
a. It was the practice of the laboratory to use the to identify any patients affected or
b4 to perform and report patient having the potential to be affected by
routine chemistry serum testing. Examples of this issue.
b 4 included ALT, BUN, calcium, glucose, and
sodium. The lab will ensure that the new lab
b. According to the laboratory's protocol titled

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(X4)1D SUMMARY STATEMENT OF DEFICIENCIES ID PROVIDER'S PLAN OF CORRECTION {X5)
REGULATORY OR LSC IDENTIFYING INFORMATION) . TAG CROSS-REFERENCED TO THE APPROPRIATE DATE
TAG
DEFICIENCY)
"Master Validation Plan for Routine Chemistry
Assays on Theranos Devices," "for establishing
monitors lab procedures, including
the trueness or comparability of two procedures .. verification and validation procedures,
.at least 50% of samples should be outside the through oversight during monthly QA
reference interval." meetings, through audits performed
pursuant to the lab's new audit
c. A review of the test results used by the procedures, and through use of a new
laboratory to establish "the trueness or
comparability of two procedures" for ALT, BUN, on-site visit log that records the lab
calcium, glucose, and sodium testing using the director's time spent physically in the
b4 showed that the laboratory did not lab.
follow its established protocol and use "at least
50% of samples ... outside the reference interval." This improved oversight will ensure
i. For a validation document dated April 2,
2015, ALT test results used to establish "the the lab's enhanced procedures for
trueness or comparability of two procedures" for method verification. Before any
tests performed using the b4 6 of 110 verification studies are performed,
ALT test results used were outside the these improved procedures require the
laboratory's reference interval. lab director's review and approval of a
ii. For a validation document dated April 21,
2015, BUN test results used to establish "the containing defined acceptance criteria.
trueness or comparability of two procedures" for The lab director must also review and
tests performed using the b4 , 1 of 109 approve the verification report before
BUN test result used was outside the laboratory's any patient testing begins. The lab has
reference interval. conducted training on those
iii. For a validation document dated April 21,
procedures.
2015, calcium test results used to establish "the
trueness or comparability of two procedures" for The lab will ensure that the new lab
tests performed using the b4 1 of 110 director also implements enhanced
calcium test result used was outside the validation procedures, which will
laboratory's reference interval. nclude review processes and
iv. For a validation document dated April 21, acceptance criteria similar to the
2015, glucose test results used to establish "the improved method verification
trueness or comparability of two procedures" for
tests performed using the b4 6 of 11 O
FORM CMS-2567(02-99) Previous Versions Obsolete Event ID:W34211 Facility ID: CA22046272 If continuation 'sheet Page 78 of 121
PRINTED: 01/25/2016
CENTERS FOR MEDICARE & MEDICAID SERVICE'S OMB NO 0938-0391
f%f: STATEMENT OF DEFICIENCIES (X1) PROVIDER/SUPPLIER/CUA (X2) MULTIPLE CONSTRUCTION (X3) DATE SURVEY
\{@@ PLAN OF CORRECTION IDENTIFICATION NUMBER: A. BUILDING _ _ _ _ _ _ __ COMPLETED
0502025714 B. WING _ _ _ _ _ _ _ __
11/20/2015
7333 GATEWAY BLVD
THERANOS INC
NEWARK, CA 94560
TAG TAG
DEFICIENCY)

glucose test results used were outside the
06086
~~~!~!~?:1~:u;f the other l
required procedures. Relevant lab
laboratory's reference interval.
personnel will receive training and
v. For a validation document dated April 1, competency on those procedures to
2015, sodium test results used to establish "the ensure that practice is consistent with
trueness or comparability of two procedures" for them.
tests performed using the b4 , 1 of 113
sodium test result used was outside the
laboratory's reference interval.
D6086 #3 2/12/16
3. Based on laboratory personnel interviews and The lab directors during the period
establishment of performance specifications covered by the survey no longer hold
record review on November 17, 2015, the any position with the lab. The new
laboratory director failed to ensure that ALT, BUN,
calcium, glucose, and sodium verification
procedures used were adequate to determine the survey had been completed.
precision of the laboratory's b4 testing
methods. Findings includ·ed: The lab has completed an assessment
a. It was the practice of the laboratory to use the having the potential to be affected by
b4 to perform and report patient
routine chemistry serum testing. Examples of
this issue.
b 4 included ALT, BUN, calcium, glucose, and The lab will ensure that the new lab
sodium. director effectively implements and
monitors lab procedures, including
b. A review of laboratory documents verification and validation procedures,
establishing performance specifications for ALT,
BUN, calcium, glucose, and sodium performed
through oversight during monthly QA
using the b4 indicated that the coefficient meetings, through audits performed
of variation (CV) determined by the laboratory's pursuant to the lab's new audit
testing differed from the CV established by the procedures, and through use of a new
manufacturer. on-site visit log that records the lab
i. For ALT, based on a laboratory document
dated April 2, 2015, the laboratory determined lab.
ALT b4 CV's between 2.0 • 5.5. The
manufacturer's established ALT CV's were This improved oversight will ensure
between 1.6 - 3.1.
J.:::>V NOIJ.'\iJ"lrnO.!:lN[ i£0 :w:oa:mrai£ filIJ. ~l:[CIN[l mmso~:::>Sia Ji'IIO~ J.clW3XlI NOIJ.'\fJ"lrnO.!:lN[ 'IVI:)~3:Ji'IIJi'IIO:) ~NlICIIi£NO:::>
PRINTED: 01/25/2016
0502025714 B. WING _ _ _ _ _ _ _ __
11/20/2015 .
7333 GATEWAY BLVD
THERANOS INC
NEWARK, CA 94560
TAG REGULATORY OR LSC IDENTIFYING INFORMATION) TAG .CROSS-REFERENCED TO THE APPROPRIATE DATE
DEFICIENCY)
ii. For BUN, based on a laboratory document
the lab's enhanced procedures for
dated April 21, 2015, the laboratory determined method verification. Before any
BUN b4 CV's between 2.1-2.7. The verification studies are performed,
manufacturer's established BUN CVs were these improved procedures require the
between 1.7 - 2.4. lab director's review and approval of a
iii. For calcium, based on a laboratory document
dated April 21, 2015, the laboratory determined containing defined acceptance criteria.
calcium b4 CV's between 2.0 - 3.6. The The lab director must also review and
manufacturer's established calcium CV's were approve the verification report before
between 0.8 - 2.1. any patient testing begins. The lab has
iv. For glucose, based on a laboratory document
procedures.
dated April 21, 2015, the laboratory determined
glucose b4 CV's between 1.5 - 2.2. The
manufacturer;s established glucose CV's were The lab will ensure that the new lab
between 0.7 - 0.9. director also implements enhanced
validation procedures, which will
v. For sodium, based on a laboratory document include review processes and
sodium CVs between 1.2 - 1.3. The
acceptance criteria similar to the
b4
manufacturer's established sodium CV's were improved method verification
between 0.6 - 1.1. procedures, along with the other
required procedures. Relevant lab
c. The laboratory provided no written personnel will receive training and
explanation/investigation as to why the laboratory competency on those procedures to
obtained CV's for ALT, BUN, calcium, glucose,
and sodium using the b4 that were
ensure that practice is consistent with
greater than the CV's established by the them.
manufacturer. Laboratory records Indicated that
these laboratory documents were approved by
the laboratory director on September 19, 2015.
D6086 #4 2/12/16
establishment of performance specifications The lab directors during the period
record review on November 17, 2015, the covered by the survey no longer hold
laboratory director failed to ensure that ALT, BUN, any position with the lab. The new
calcium, and glucose verification procedures
PRINTED: 01/25/2016
STATEMENT OF DEFICIENCIES (X1) PROVIDER/SUPPLIERICLIA (X2) MULTIPLE CONSTRUCTION (X3) DATE SURVEY
0502025714 B.WING
11/20/2015
7333 GATEWAY BLVD
THERANOS INC
NEWARK, CA 94560
TAG
DEFICIENCY)
06068 #4 (continued)
used were adequate to determine pertinent
performance characteristics, such as reference
range, of the laboratory's b4 testing
methods. Findings included: The lab has completed an assessment
a. It was the practice of the laboratory to use the having the potential to be affected by
b4 to perform and report patient
this issue.
routine chemistry serum testing. Examples of
b 4 included ALT, BUN, calcium, and glucose. The lab will ensure that the new lab
b. A review of laboratory documents monitors lab procedures, including
establishing performance specifications for ALT, verification and validation procedures,
BUN, calcium, and glucose performed using the
b4
through oversight during monthly QA
indicated that the reference range
determined by the laboratory's testing differed meetings, through audits performed
from the reference range on the laboratory's test pursuant to the lab's new audit
reports. procedures, and through use of a new
on-site visit log that records the lab
i. For ALT, based on a laboratory document director's time spent physically in the
dated April 2, 2015, the laboratory determined the
ALT b4 reference range as O - 52 U/L.
lab.
However, the laboratory's reference range on the
test reports was 8 - 41 U/L. This improved oversight will ensure
ii. For BUN, based on a laboratory document the lab's enhanced procedures for
dated April 21, 2015, the laboratory determined method verification. Before any
the BUN b4 reference range as 5.3 -
22.5 mg/dL. However, the laboratory's reference
verification studies are performed,
range on the test reports was 6 - 24 mg/dL. these improved procedures require the
iii. For calcium, based on a laboratory document detailed method verification plan
dated April 21, 2015, the laboratory determined containing defined acceptance criteria.
the calcium b4 reference range as 8.18 -
10.3 mg/dL. However, the laboratory's reference
range on the test reports was 8.3 - 10.6 mg/dL.
iv. For glucose, based on a laboratory document

\
\.
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PRINTED: 01/25/2016
0502025714 B.WING 11/20/2015 .

7333 GATEWAY BLVD
THERANOS INC
NEWARK, CA 94560
TAG TAG
DEFICIENCY)
The lab director must also review and
the glucose b4 reference range as 64. O -
112.3 mg/dl. However, the laboratory's
approve the verification report before
reference range on the test reports was 73 - 99 any patient testing begins. The lab has
mg/dL. conducted training on those
procedures.
c. The laboratory provided no written
explanation/investigation as to why the laboratory Any update to a reference range is
obtained reference ranges for ALT, BUN, calcium,
and glucose were different than than the reviewed and approved by the lab
reference ranges indicated on the test reports .. director or a clinical consultant, and
Laboratory records indicated that these laboratory the lab has procedures to ensure that
documents were approved by the laboratory data on patient reports are consistent
director on September 19, 2015. with established reference ranges. In
addition, the lab will ensure that the
complete blood counts (CBC) verification of new lab director also implements
method specifications record review on enhanced validation procedures,
November 19, 2015, the -laboratory director failed which will include review processes
to ensure that verification procedures used were and acceptance criteria similar to the
adequate to determine the accuracy, precision, improved method verification
procedures, along with the other
for the two Siemens Advia 2120i instruments.
Findings included: required procedures. Relev~t lab
personnel will receive training and
a. It was the practice of the laboratory to test competency on those procedures to
patient venous CBC specimens using two ensure that practice is consistent with
Siemens Advia 2120i instruments, designated as them.
#1 and #2.
b. Although the laboratory maintained

verification of test performance specifications
documents for the two Advia 2120i instruments,
the laboratory maintained no documentation to
indicate that verification results for the two
instruments were acceptable to the laboratory, no
evidence that the laboratory director had
reviewed and approved the verification
documents, and no date the verification
documents were reviewed and approved.
.L:::>V NOI.LYmO!I.NI .!IO woaa:ffiTII HHL 1IHCINO. ffiIDSO~:::>sm W01Ill .LdWHXH NOI.LVli'llliOtlNI 'IVI:::>1J:HWW0;) 'IVI.LNHaIIINO:::>
)
PRINTED: 01/25/2016
0502025714 B. WING _ _ _ _ _ _ _ __
11/20/2015 ·
7333 GATEWAY BLVD
THERANOSINC
NEWARK, CA 94560
TAG TAG
DEFICIENCY)

the glucose b4 reference range as 64.0 -
112.3 mg/dl. However, the laboratory's
reference range on the test reports was 73 - 99
mg/dl.
c. The laboratory provided no written

explanation/investigation as to why the laboratory
obtained reference ranges for ALT, BUN, calcium,
and glucose were different than than the
reference ranges indicated on the test reports ..
Laboratory records indicated that these laboratory
documents were approved by the laboratory
director on September 19, 2015.

complete blo9d counts (CBC) verification of D6086 #5 2/12/16
method specifications record review on The lab directors during the period
November 19, 2015, the .laboratory director failed covered by the survey no longer hold
to ensure that verification procedures used were any position with the lab. The new
adequate to determine the accuracy, precision, lab director was hired after the on-site
for the two Siemens Advia 2120i instruments.
Findings included:
a. It was the practice of the laboratory to test to identify any patients affected or
patient venous CBC specimens using two having the potential to be affected by
Siemens Advia 2120i instruments, designated as this issue.
#1 and #2.
b. Although the laboratory maintained The lab will ensure that the new lab
verification of test performance specifications director effectively implements and
documents for the two Advia 2120i instruments, monitors lab procedures, including
the laboratory maintained no documentation to verification procedures, through
indicate that verification results for the two oversight during monthly QA
instruments were acceptable to the laboratory, no
evidence that the laboratory director had meetings, through audits performed
reviewed and approved the verification pursuant to the lab's new audit
documents, and no date the verification
documents were reviewed and approved.
FORM CMS-2567(02-99) Previous Versions Obsolete Event ID:W34211 Facility ID: CA22046272 If continuatiori sheet Page 82 of 121
J.:::>V NOIJ.VW1:IO.!lNI .!IO WOOHffiltl ffill 1IHCINfl ffilflSO'DSia WOM J.dli'IIHXH NOIJ.VW1!0.!lNI 'IVI:::>1!8:WWO:::> 'IVI.LNHGitlNO:::>
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0502025714 B. WING _ _ _ _ _ _ _ __
11/20/2015 ·
7333 GATEWAY BLVD
THERANOS INC
NEWARK, CA 94560
DEFICIENCY)

D6068 #5 ( continued)
procedures, and through use of a new
2015, the laboratory performed and reported on-site visit log that records the lab
2,395 patient CBC test results using the Advia director's time spent physically in the
2120i #1. From November 6, 2015 to November lab.
#2.
6. Based on review of documentation, lack of the lab's enhanced procedures for
documentation, observation and interview with method verification. Before any
the general supervisor, the laboratory director verification studies are performed,
failed to ensure that the laboratory determined these improved procedures require the
the mean normal prothrombin time (MNPT) prior
to implementing a new lot number of lnnovin
(thromboplastin) on the Siemens BCS XP. detailed method verification plan
Findings include: containing defined acceptance criteria.
The lab director must also review and
a. Dade lnnovin (thromboplastin) lot number approve the verification report before
539280 was put into use in March 2015. any patient testing begins. The lab has
b. The test system required that the MNPT (in
seconds) be calculated for each new lot number procedures.
of lnnovin.
c. The MNPT specific to the lot number of

lnnovin was to be entered into the BCS XP.
d. The MNPT was observed on 9/23/15 at

approximately 3:25 pm revealed the correct
MNPTwas entered into the BCS XP.
e. Review of the MNPT data revealed that the

MNPT data was performed on 9/18/15.
f. The general supervisor stated that there

should be date from March 2015; however, the
documentation could not be located.
PRINTED: 01/25/2016
tfVi\ STATEMENT OF DEFICIENCIES (X1) PROVIDER/SUPPLIER/CUA {X2) MULTIPLE CONSTRUCTION {X3) DATE SURVEY
\@} AND PLAN OF CORRECTION IDENTIFICATION NUMBER: A. BUILDING _ _ _ _ _ _ __ COMPLETED
B. WING _ _ _ _ _ _ _ __
0502025714 11/20/2015
7333 GATEWAY BLVD
THERANOS INC
NEWARK, CA 94560
{X4)1D SUMMARY STATEMENT OF DEFICIENCIES ID PROVIDER'S PLAN OF CORRECTION {X5)
PREFIX {EACH DEFICIENCY MUST BE PRECEDED BY FULL PREFIX {EACH CORRECTIVE ACTION SHOULD BE COMPLETION
TAG
DEFICIENCY)

2120i #1. From November 6, 2015 to November
#2.
6. Based on review of documentation, lack of D6068 #6: 2/12/16

documentation, observation and interview with The lab directors during the period
the general supervisor, the laboratory director covered by the survey no longer hold
failed to ensure that the laboratory determined any position with the lab. The new lab
the mean normal prothrombin time (MNPT) prior
to implementing a new lot number of lnnovin
(thromboplastin) on the Siemens BCS XP. survey had been completed.
Findings include:
This PT/INR issue related to one
a. Dade lnnovin (thromboplastin) lot number reagent lot. The lab paused testing on
539280 was put into use in March 2015. the Siemens BCS XP, including
b. The test system required that the MNPT (in
PT/INR, during the survey. The lab
seconds) be calculated for each new lot number has also completed an assessment to
of lnnovin. identify any patients affected or
c. The MNPT specific to the lot number of this issue.
lnnovin was to be entered into the BCS XP.
d. The MNPT was observed on 9/23/15 at

approximately 3:25 pm revealed the correct director effectively implements and
MNPT was entered into the BCS XP. monitors lab procedures, including
reagent qualification and management
e. Review of the MNPT data revealed that the procedures, through oversight during
MNPT data was performed on 9/18/15. monthly QA meetings, through audits
f. The general supervisor stated that there performed pursuant to the lab's new
should be date from March 2015; however, the audit procedures, and through use
documentation could not be located.
PRINTED: 01/25/2016
0502025714 B. WING _ _ _ _ _ _ _ __
11/20/2015
7333 GATEWAY BLVD
THERANOS INC
NEWARK, CA 94560
TAG TAG
DEFICIENCY)

06093 493.1445(e)(5) LABORATORY DIRECTOR
RESPONSIBILITIES
o:~:~
D
of a new on-site visit log that records
the lab director's time spent physically
The laboratory director must ensure that the in the lab.
quality control programs are established and
maintained to assure the quality of laboratory The lab's enhanced procedures for
services provided and to identify failures in quality reagent qualification and management
as they occur.
This STANDARD is not met as evidenced by: include procedures to ensure
1. Based on laboratory personnel interviews, manufacturer inserts are reviewed.
direct observations, and quality control document Training on these procedures has
reviews, the laboratory director failed to ensure occurred.
that quality control programs were established
and maintained to assure the quality of laboratory Before PT/INR testing resumes, the
services provided and to identify failures in quality
as they occur: The laboratory director failed to lab will also ensure that the new lab
ensure that the laboratory included two quality director prepares and implements a
control materials at least once each day patient revised assay-specific procedure for
specimens were examined (see 05447), the PT/INR to reinforce that the Mean
laboratory included a positive control material at Normal Prothrombin Time (MNPT)
least once each day patient specimens were
assayed (see 05449), stated values of
must be calculated for each new lot
commercially assayed quality control materials number of Innovin. The relevant
were verified (see 05469), each batch of media testing personnel will be required to
was checked for its ability to support growth (see demonstrate competency to ensure
05477), results of quality control materials met that practice is consistent with these
the laboratory's criteria for acceptability (see procedures.
05481 ), and the laboratory followed established
quality control corrective action protocols (see
05779).
2. Based on review of the prothrombin

time/international normalized ratio (PT/INR)
procedure, quality control (QC) records and
interview with the general supervisor, the
laboratory director failed to ensure that the QC for
PT/INR was acceptable prior to reporting patient
results and failed to identify that the QC data
revealed a shift greater than 2 standard
.L:::>V NOI.LVli'rnO.ifNI 110 WOG1IH"&I 3HL ~HCINfl ffiID.SO'I::)SIQ WOTuI .Ldli'i[HXH NOI.L~O.if.NI 'IVI:::>~HWWO:::> 'IVI.LNHGIIINO:::>
CONFIDENTIAL COMl'vIBRCIAL INFORMATION EXEMPT FROM DISCLOSURE UNDER THE FREEDOM OF INFORMATION ACT
PRINTED: 01/25/2016
cnt
\(fa)
A BUILDING _ _ _ _ _ _ __
(X3) DATE SURVEY
COMPLETED
0502025714 B. WING _ _ _ _ _ _ _ __
11/20/2015 ·
7333 GATEWAY BLVD
THERANOS INC
NEWARK, CA 94560
TAG TAG
DEFICIENCY)

oao 93 D6093 #1 2/12/16
06093 493.1445(e)(5) LABORATORY DIRECTOR
RESPONSIBILITIES
o5o93 The lab directors during the period
The laboratory director must ensure that the any position with the lab. The new lab
quality control programs are established and director was hired after the on-site
maintained to assure the quality of laboratory survey had been completed.
as they occur.
1. Based on laboratory personnel interviews, to identify any patients affected or
direct observations, and quality control document having the potential to be affected by
reviews, the laboratory director failed to ensure this issue.
that quality control programs were established
and maintained to assure the quality of laboratory The lab will ensure that the new lab
·, as they occu~. The laboratory director failed to director effectively implements and
ensure that the laboratory included two quality monitors lab procedures, including the
control materials at least.once each day patient lab's improved quality systems and
specimens were examined (see 05447), the related procedures, through oversight
laboratory included a positive control material at during monthly QA meetings, through
least once each day patient specimens were
audits performed pursuant to the lab's
assayed (see 05449), stated values of
commercially assayed quality control materials new audit procedures, and through use
were verified (see 05469), each batch of media of a new on-site visit log that records
was checked for its ability to support growth (see the lab director's time spent physically
05477), results of quality control materials met in the lab.
the laboratory's criteria for acceptability (see
05481 ), and the laboratory followed established
quality control corrective action protocols (see
05779).
2. Based on review of the prothrombin D6093 #2 2/12/16

time/international normalized ratio (PT/INR) The lab directors during the period
procedure, quality control (QC) records and covered by the survey no longer hold
interview with the general supervisor, the
laboratory director failed to ensure that the QC for any position with the lab. The new lab
PT/INR was acceptable prior to reporting patient director was hired after the on-site
results and failed to identify that the QC data survey had been completed.
revealed a shift greater than 2 standard
FORM CMS-2567(02-99) Previous Versions Obsolete Event iD:W34211 Facility JD: CA22046272 If continuatiori sheet Page 84 of 121
J.:::>V NOIJ.VJi'lraOiINI tlO W:008:ffiltl ffill 118:0NO. ffiIO.SO'DSIO WOU J.dJ,'il:8:XH NOIJ.VJi'lraOIINI 'IVI:::>118:WWO;J '1VIJ.N8:CIItlNO:::>
PRINTED: 01/25/2016
tf]%, STATEMENT OF DEFICIENCIES (X1) PROVIDER/SUPPLIER/CUA (X2) MULTIPLE CONSTRUCTION (X3) DATE SURVEY
\'.jj) AND PLAN OF CORRECTION IDENTIFICATION NUMBER: A. BUILDING _ _ _ _ _ _ __ COMPLETED
B. WING _ _ _ _ _ _ _ __
0502025714 11/20/2015 .
7333 GATEWAY BLVD
THERANOS INC
NEWARK, CA 94560
TAG TAG
DEFICIENCY)
In addition, the lab paused testing on
deviations (SD) from April 2015 through
September 2015. Findings include:
the Siemens BCS XP, including
a. CL SOP-10001 Revision A, "Measuring has also completed an assessment to
Prothrombin Time-lnnovin (PT on the Siemens identify any patients affected or
BCS XP Instrument" stated on page 6, section having the potential to be affected by
8.6 that if control values are outside of the
this issue.
determined range, the controls, reagents and
instrument performance should be checked and
that identification and correction of the problem The lab will ensure that the new lab
shoud be documented prior to reporting patient director effectively implements and
results. monitors lab procedures, including QC
procedures, through oversight during
b. QC records for Citrol 3 (Lot number 548425)
monthly QA meetings, through audits
were reviewed from 4/1 /15 through 9/23/15.
performed pursuant to the lab's new
c. The general supervisor stated that QC was audit procedures, and through use of a
acceptable if the values were +I- 2 SD from the new on-site visit log that records the
mean. lab director's time spent physically in
the lab.
d. From April 1, 2015 through September 16,
2015, 32 of 69 days showed Citro I 3 QC values
were greater than 2 SD (- 2 SD) below the mean. This improved oversight wi~l ensure
e. On 4/7/15, Citrol 3 was run six times before the lab's enhanced QC procedures,
an acceptable QC value was obtained. which reinforce and detail the required
investigation and corrective action that
f. On 9/7/15, Citrol 3 was run seven times
without obtaining an acceptable QC value.
must occur to address QC issues
before patient tests are performed and
g. On 9/8/15, Citrol 3 was run twelve times clarify which employees are
without obtaining an acceptable QC value. responsible for performing and
documenting these activities. The lab
h. On 25 of 32 days, Citrol 3 was not retrun has conducted training and
when the QC value was greater than - 2 SD.
competency testing on those
i. On 5/15/15, 8/13/15, 8/21 /15 and 9/10/15, procedures to ensure that practice is
Citrol 3 was run twice. All QC results were consistent with them.
unacceptable.
PRINTED: 01/25/2016
6fl\ STATEMENT OF DEFICIENCIES (X1) PROVIDER/SUPPLIER/CLIA (X2) MULTIPLE CONSTRUCTION (X3) DATE SURVEY
IQ]) AND PLAN OF CORRECTION IDENTIFICATION NUMBER: A. BUILDING _ _ _ _ _ _ __ COMPLETED
0502025714 B. WING _ _ _ _ _ _ _ __
11/20/2015
7333 GATEWAY BLVD
THERANOSINC
NEWARK, CA 94560
TAG TAG
DEFICIENCY)
j. TheRule Check report revealed that 13 of 13

QC values in April 2015, 2 of 17 in May 2015, 7 of
7 in June 2015; 13 of 13 in July 2015, 16 of 16 in
August and 24 of 24 9/1-9/16 2015 showed rule
violation messages related to Citro! 3.
k. On approximately 9/16/15, the labortory

adjusted the acceptable range for Citro! 3 to
match the data. This change was implemented
without any investigation as to the reason for the
shift in control values.
I. 81 patients were reported from 4/1/15

through 9/16/15.
RESPONSIBILITIES D6094 # 1: 2/12/16
The laboratory director must ensure that the covered by the survey no longer hold
quality assessment program~ are established and any position with the lab. The new lab
maintained to assure the quality of laboratory director was hired after the on-site
services provided arid to identify failures in quality
as they occur.
survey had been completed ..
1. Based on laboratory personnel interviews, The lab has completed an assessment
direct observations, and quality control document to identify any patients affected or
reviews, the laboratory director failed to ensure having the potential to be affected by
that quality assessment programs were
this issue.
established and maintained to assure the quality
of laboratory services provided and to identify
failures in quality as they occur. The laboratory The new lab director is responsible for
director failed to ensure that preanalytic (see the lab's QA program and has
05391 and 05393) and analytic (see 05791 and approved enhanced quality systems
05793) systems quality assessment programs and related procedures concerning
were established, followed, and effective.
pre-analytic, analytic, and
2. Based on review of documentation and lack post-analytic issues (see D5391,
of documentation, the laboratory director failed to D5393, D5791, and D5793).
.L:)V NOI.LVJi'raO.iNI 110 woamnw: filI.L 1IHCINC1 ffiiflSO'I::)SIG W01Ill .LdW:'.3X1I NOI.LVJi'raO.iNI 'IVI:)'fillli\lli'iJ:0:) 'IVI.LN1ICIIllN0:)
PRINTED: 01/25/2016
LE> STATEMENT OF DEFICIENCIES (X1) PROVIDER/SUPPLIER/CUA (X2) MULTIPLE CONSTRUCTION (X3) DATE SURVEY
\JU> AND PLAN OF CORRECTION IDENTIFICATION NUMBER: A. BUILDING _ _ _ _ _ _ __ COMPLETED
0502025714 B. WING _ _ _ _ _ _ _ __
11/20/2015 .
7333 GATEWAY BLVD
THERANOSINC
NEWARK, CA 94560
TAG TAG
DEFICIENCY)
j. TheRule Check report revealed that 13 of 13 director effectively implements and
QC values in April 2015, 2 of 17 in May 2015, 7 of monitors these procedures through
7 in June 2015; 13 of 13 in July 2015, 16 of 16 in audits performed pursuant to the lab's
August and 24 of 24 9/1-9/16 2015 showed rule new audit procedures, through
violation messages related to Citro! 3. oversight during monthly QA
meetings, and through use of a new
k. On approximately 9/16/15, the labortory
adjusted the acceptable range for Citro! 3 to on-site visit log that records the lab
match the data. This change was implemented director's time spent physically in the
without any investigation as to the reason for the lab.
shift in control values.
I. 81 patients were reported from 4/1 /15

through 9/16/15.
RESPONSIBILITIES
The laboratory director must ensure that the

quality assessment program!:} are established and
maintained to assure the quality of laboratory
as they occur.
1. Based on laboratory personnel interviews,
direct observations, and quality control document
reviews, the laboratory director failed to ensure
that quality assessment programs were
established and maintained to assure the quality
of laboratory services provided and to identify
failures in quality as they occur. The laboratory
director failed to ensure that preanalytic (see
05391 and 05393) and analytic (see 05791 and
05793) systems quality assessment programs
were established, followed, and effective.
D 6094 #2: 2/12/16
2. Based on review of documentation and lack The lab directors during the period
of documentation, the laboratory director failed to covered by the survey no longer
PRINTED: 01/25/2016
ll} STATEMENT OF DEFICIENCIES (X1) PROVIDER/SUPPLIER/CLIA (X2) MULTIPLE CONSTRUCTION (X3) DATE SURVEY
\@b: AND PLAN OF CORRECTION IDENTIFICATION NUMBER: A BUILDING _ _ _ _ _ _ __ COMPLETED
0502025714 B. WING _ _ _ _ _ _ _ __
11/20/2015 .
7333 GATEWAY BLVD
THERANOS INC
NEWARK, CA 94560
TAG TAG
DEFICIENCY)
identify failures in Prothrombin Time/International
oeo 94 hold any position with the lab. The
Normalized Ratio (PT/INR) testing which affected
new lab director was hired after the
the quality of the PT/INR patient results. Findings on-site survey had been completed.
include:
In addition, the lab paused testing on
a. The Dada lnnovin (thromboplastin) reagent the Siemens BCS XP, including
was used past the expiration date. Refer to
05413.
has also completed an assessment to
b. The quality control data from 4/1/2015 identify any patients affected or
through 9/16/15 revealed that patient results having the potential to be affected by
above normal were biased low (i.e., reported this issue.
value was lower than it should have been
reported).
c. The target INR value for patients on Warfarin director effectively implements and
therapy was 2-3. monitors lab procedures, including QC
procedures, through oversight during
d. 81 patients were reported from 4/1/15 monthly QA meetings, through audits
through 9/21/15. performed pursuant to the lab's new
e. 44 of 81 patients had IN Rs greater than or
audit procedures, and through use of a
equal to 2 reported and of the 44, 16 of the 44 new on-site visit log that records the
had INR greater than or equal to 3 reported. lab director's time spent physically in
the lab.
f. There was no quality assessment (QA) or
other documentation to indicate that the PT/INR
failure had been identified and corrected.
RESPONSIBILITIES the lab's enhanced QC procedures,
which reinforce and detail the required
The laboratory director must ensure that reports investigation and corrective action that
of test results include pertinent information must occur to address QC issues
required for interpretation. before patient tests are performed,
Based on review of final test reports and
and clarify which employees are
interview with the Senior Vice President, the responsible for performing and
laboratory director failed to ensure that the
PRINTED: 01/25/2016
j(J:; STATEMENT OF DEFICIENCIES (X1) PROVIDER/SUPPLIER/CLIA (X2) MULTIPLE CONSTRUCTION (X3) DATE SURVEY
\)$) AND PLAN OF CORRECTION IDENTIFICATION NUMBER: A. BUILDING _ _ _ _ _ _ __ COMPLETED
0502025714 B.WING 11/20/2015

7333 GATEWAY BLVD
THERANOS INC
NEWARK, CA 94560
TAG
DEFICIENCY)
documenting these activities. The lab
identify failures in Prothrombin Time/International
Normalized Ratio (PT/INR) testing which affected
has conducted training and
the quality of the PT/INR patient results. Findings competency testing on those
include: procedures to ensure that practice is
a. The Dada lnnovin (thromboplastin) reagent
was used past the expiration date. Refer to
05413.
b. The quality control data from 4/1/2015

through 9/16/15 revealed that patient results
above normal were biased low (i.e., reported
value was lower than it should have been
reported).
c. The target INR value for patients on Warfarin

therapy was 2-3.
d. 81 patients were reported from 4/1/15

through 9/21/15.
e. 44 of 81 patients had IN Rs greater than or

equal to 2 reported and of the 44, 16 of the 44
had !NR greater than or equal to 3 reported.
f. There was no quality assessment (QA) or

other documentation to indicate that the PT/INR
failure had been identified and corrected.
D6098 2/12/16
RES PON SI Bl LITI ES The lab directors during the period
The laboratory director must ensure that reports any position with the lab. The new lab
of test results include pertinent information director was hired after the on-site
required for interpretation. survey had been completed.
Based on review of final test reports and
interview with the Senior Vice President, the The lab revised its patient reports for
laboratory director failed to ensure that the PT/INR during the survey so that the
.L8V NOI.LVJi'raOtlN[ ilO WOQH~tl Hill <lHGNfl ffi!O.S0'1:::>Sra WOTuI .LclWHXH NOI.LVJi'raO.iNI 'IVI::rna:wwo:::> 'IVI.LNHOitlNO:)
PRINTED: 01/25/2016
tU> STATEMENT OF DEFICIENCIES
\[@) AND PLAN OF CORRECTION
COMPLETED
A. BUILDING _ _ _ _ _ _ __
0502025714 B. WING _ _ _ _ _ _ _ __
11/20/2015
7333 GATEWAY BLVD
THERANOSINC
NEWARK, CA 94560
TAG TAG
DEFICIENCY)
D6098 (continued)
interpretive note appears only under
interpretive data on the Prothrombin
the heading for patients under therapy.
Time/International Normalized Ratio (PT/INR)
final reports was clear to differentiate between The lab has completed an assessment
Warfarin therapy and non-Warfarin therapy. to identify any patients affected or
Refer to 05805. having the potential to be affected by
06102 493.1445(e)(12) LABORATORY DIRECTOR 06102 this issue.
RESPONSIBILITIES
The laboratory director must ensure that prior to
testing patients' specimens, all personnel have revised reporting procedures that
the appropriate education and experience, require the technical supervisor to
receive the appropriate training for the type and verify that interpretive information is
complexity of the services offered, and have accurate and to obtain approval from
demonstrated that they can perform all testing the lab director or clinical consultant
··.. operations reliably to provide and report accurate
before any updates are implemented.
results.
Based on review of training documents and The lab will ensure that the new lab
interview with the QNQC (Quality director effectively implements and
Assurance/Quality Control) Manager, technical monitors these procedures through
supervisor and testing personnel, the laboratory audits performed pursuant to the lab's
failed to document training of testing personnel
on the Theranos Proprietary System (TPS) prior new audit procedures, through
to patient testing and failed to document training oversight during monthly QA
in the vacutainer laboratory of testing personnel meetings, and through use of a new
prior to patient testing. Findings include: on-site visit log that records the lab
a. Theranos Proprietary System (TSP) lab.
i. The QNQC Manager and technical
supervisor stated that all training documentation (D6102 begins on next page)
was kept in each testing person's employee file.
ii. Eleven testing personnel files were reviewed.
iii. Eight of eleven personnel files did not include

any documentation of training on the TPS prior to
running and reporting patient test results.
J.;)V NOIJ.VJi'lraO;INI iIO womiffiliI 3RL 113:GN!l ffilflSO'I:JSia W01Iil .LdJi\T3XH NOil.VJi'lraOiINI 'IVI:J1IBJi'®'iJ:o;) 'IVLLNHaiiINO;)
CONFIDENTIAL COMM:ERCIAL INFORMATION EXEMPT FROM DISCLOSURE UNDER THE FREEDOM OF INFORMATION ACT
PRINTED: 01/25/2016
DEPARTMENT OF HEALTH AND HUMAN SERVICl;S FORM APPROVED
iff\ ' STATEMENT OF DEFICIENCIES (X1) PROVIDER/SUPPLIER/CUA (X2) MULTIPLE CONSTRUCTION (X3) DATE SURVEY
\@ } AND PLAN OF CORRECTION IDENTIFICATION NUMBER: A. BUILDING _ _ _ _ _ _ __ COMPLETED
0502025714 B. WING _ _ _ _ _ _ _ __
11/20/2015
7333 GATEWAY BLVD
THERANOSINC
NEWARK, CA 94560
TAG
DEFICIENCY)

interpretive data on the Prothrombin
Time/International Normalized Ratio (PT/INR)
final reports was clear to differentiate between
Warfarin therapy and non-Warfarin therapy. D6102 2/12/16
Refer to 05805. The lab directors during the period
06102 493.1445(e)(12) LABORATORY DIRECTOR 06102 covered by the survey no longer hold
RESPONSIBILITIES any position with the lab. The new lab
The laboratory director must ensure that prior to
testing patients' specimens, all personnel have survey had been completed.
the appropriate education and experience,
receive the appropriate training for the type and The lab has completed an assessment
complexity of the services offered, and have to identify any patients affected or
demonstrated that they can perform all testing having the potential to be affected by
operations reliably to provide and report accurate
results. · this issue.
Based on review of training documents and The new lab director has approved
interview with the QA/QC (Quality enhanced procedures to ensure that
Assurance/Quality Control) Manager, technical testing personnel are qualified, have
supervisor and testing personnel, the laboratory
received training, and are competent
failed to document training of testing personnel
on the Theranos Proprietary System (TPS) prior before performing any test on any
to patient testing and failed to document training instrument, and to ensure that those
in the vacutainer laboratory of testing personnel qualifications, training, and
prior to patient testing. Findings include: competency are documented.
Training on these procedures has
a. Theranos Proprietary System (TSP)
occurred to ensure the practice is
i. The QA/QC Manager and technical consistent with them.
supervisor stated that all training documentation
was kept in each testing person's employee file. The lab will ensure that the new lab
ii. Eleven testing personnel files were reviewed. monitors lab procedures, including
personnel procedures, through audits
iii. Eight of eleven personnel files did not include
any documentation of training on the TPS prior to performed pursuant to the lab's new
running and reporting patient test results.
.L'JV NOUVli'IBO!INI .!IO WOG:IffiIII ffill 1£:ICIN(l lnifiSO'I'JSia W01Ii! .LdJlilIIXH NOI.LVli'IBO!INI 'IVI'J1IHWWO::J 'IVI.LNHCIIdNO'J
PRINTED: 01/25/2016
i{'.I} STATEMENT OF DEFICIENCIES (X1) PROVIDER/SUPPLIER/CLIA (X2) MULTIPLE CONSTRUCTION (X3) DATE SURVEY
l{J{) AND PLAN OF CORRECTION IDENTIFICATION NUMBER: A BUILDING _ _ _ _ _ _ __ COMPLETED
B. WING _ _ _ _ _ _ _ __
0502025714 11/20/2015 ·
7333 GATEWAY BLVD
THERANOS INC
NEWARK, CA 94560
TAG TAG
DEFICIENCY)
D6102 (continued)
audit procedures, through oversight
during monthly QA meetings, and
b. Venipuncture Laboratory
through use of a new on-site visit log
a. The QA/QC Manager and technical that records the lab director's time
supervisor stated that all training documentation spent physically in the lab.
was kept in each testing person's employee file.
b. Three testing personnel files were reviewed.
c. Testing Person #6 (TP6) training records did

not include documentation for the Siemens XPT,
Advia 2120i, Eldon Card, and were incomplete for
the Centaur, IRIS, BC SXP and Cellavision.
d. TP6 stated that training had not been

completed as. of 9/23/15; however PT6 had been
running and reporting patient test results since
April 2015. TP6 also stated that activities listed
on the training documentation which were not
signed off were performed by TP6, but training
had not occurred.
e. TP6 confirmed the above findings on 9/23/15

at approximately 3:30 pm.
f. Testing Person #11 (TP11) training records .

did not include documentation for the Advia,
lmmulite, BC SXP, Advia 2120i, Centaur,
MacroVu RPR, Multispot HIV, and Diasorin
Liaison.
g. TP6 stated that TP11 ran and reported

patient test results from these systems.
h. Testing Person #31 (TP31)'s training

documentation included documents on critical
values and critical values logsheets. No other
training documentation was found.
FORM CMS-2567(02-99) Previous Versions Obsolete Event ID:W34211 Facility ID: CA22046272 If continuatiori sheet Page 89 of 121
(
PRINTED: 01/25/2016
.(:}}', STATEMENT OF DEFICIENCIES (X1) PROVIDER/SUPPLIER/CUA (X2) MULTIPLE CONSTRUCTION (X3) DATE SURVEY
\@)' AND PLAN OF CORRECTION IDENTIFICATION NUMBER: A. BUILDING _ _ _ _ _ _ __ COMPLETED
0502025714 B. WING _ _ _ _ _ _ _ __
11/20/2015 .
7333 GATEWAY BLVD
THERANOSINC
NEWARK, CA 94560
TAG
DEFICIENCY)

i. The general supervisor stated that TP31 had
been running and releasing patient test results.
j. The general supervisor confirmed that the

training documents were missing or incomplete
for three of three testing personnel on 11/19/15 at
11:40 am. D6108 2/12/16
06108 493.1447 LABORATORY TECHNICAL 06 108 The lab has corrected this issue by
SUPERVISOR
ensuring that all of its technical
The laboratory must have a technical supervisor supervisors meet the training and
who meets the qualification requirements of experience requirements. The new lab
§493.1449 of this subpart and provides technical director is the technical supervisor for
supervision in accordance with §493.1451 of this chemistry, hematology, and
subpart.
immunohematology. CMS already
This CONDITION is not met as evidenced by: qualified the lab's other technical
Based on the number and severity of the supervisor for microbiology and
deficiencies cited herein, the Condition: diagnostic immunology.
Laboratories performing high complexity testing;
technical supervisor was not met. Two of three TS 1 and TS2 are no longer technical
technical supervisors failed to meet the training or
experience requirement in one or more supervisors for the lab. It is. worth
specialties/subspecialties (see 06111), and the noting, however, that CMS qualified
technical supervisors failed to ensure the TS 1 as a technical supervisor for
establishment of performance specifications for chemistry and found that TS 1 was just
the Theranos Proprietary System (TPS) were months away from qualifying for
complete and followed the laboratory's procedure hematology and immunology. In
(see 06115).
06111 493.1449 TECHNICAL SUPERVISOR 06111
addition, TS2 is still endeavoring to
QUALIFICATIONS obtain documents from TS2's former
employers to show the requisite
(a) The technical supervisor must possess a experience.
current license issued by the State in which the
laboratory is located, if such licensing is required; The lab has completed an assessment
and
(b) The laboratory may perform anatomic and to identify any patients affected or
clinical laboratory procedures and tests in all
.L:::>V NOI.LVY'rnOtlNI tlO wornIIDiiI HH.L 113:CINfl ffiIDSO'I::)Sia W01Itl .LdWI!XH NOI.LVY'rnOtlNI 'lVI:::rna:wwo::> 'IVI.LNHaitlNO:::>
PRINTED: 01/25/2016
f/T\ STATEMENT OF DEFICIENCIES {X1) PROVIDER/SUPPLIER/CUA (X2) MULTIPLE CONSTRUCTION (X3) DATE SURVEY
\faj AND PLAN OF CORRECTION IDENTIFICATION NUMBER: A BUILDING _ _ _ _ _ _ __ COMPLETED
0502025714 B. WING _ _ _ _ _ _ _ __
11/20/2015 ,
7333 GATEWAY BLVD
THERANOSINC
NEWARK, CA 94560
TAG TAG
DEFICIENCY)
D6108 (continued)
this issue (see 06111, 06115).
j.
The general supervisor confirmed that the The new lab director has approved
training documents were missing or incomplete enhanced policies and procedures
for three of three testing personnel on 11/19/15 at governing personnel qualification and
11:40 am. defining, among other things, the
06108 493.1447 LABORATORY TECHNICAL 06108
education and experience
SUPERVISOR
requirements for a technical
The laboratory must have a technical supervisor supervisor (see 06111). The new lab
who meets the qualification requirements of director has also approved enhanced
§493.1449 of this subpart and provides technical procedures related to the
supervision in accordance with §493.1451 of this establishment of performance
subpart.
specifications (see 06115). The lab
( ·,
l,, This CONDITION is not met as evidenced by: has conducted training on these
Based on the number and severity of the procedures to ensure that its practice is
deficiencies cited herein, the Condition: consistent with them (see 06111 and
Laboratories performing high complexity testing; 06115).
technical supervisor was not met. Two of three
experience requirement In one or more
In addition, the lab has improved its
specialties/subspecialties (see 06111 ), and the quality systems and procedures-
technical supervisors failed to ensure the including quality assurance review,
establishment of performance specifications for monitoring, and audits-to prevent
the Theranos Proprietary System (TPS) were recurrence (see 06111 and 06115).
complete and followed the laboratory's procedure
(see 06115).
(D6111 begins on next page)
QUALi Fl CATIONS
(a) The technical supervisor must possess a

current license issued by the State in which the
laboratory is located, if such licensing is required;
and
(b) The laboratory may perform anatomic and
.L::>V NOI.LVli\IBOtlNI .m WOOH'in!d: 3RL 119:CIN(l ffilflSO'I::>Sia W01Id: .LdWtIXH NOI.LVli\IBOtlNI 'IVI81IHWW0:) 'IVI.LNHaid:NO:)
PRINTED: 01/25/2016
0502025714 B.WING 11/20/2015 .

7333 GATEWAY BLVD
THERANOSINC
NEWARK, CA 94560
TAG
DEFICIENCY)

j. The general supervisor confirmed that the

training documents were missing or incomplete
for three of three testing personnel on 11/19/15 at
11:40 am.
06108 493.1447 LABORATORY TECHNICAL 06108
SUPERVISOR
The laboratory must have a technical supervisor

who meets the qualification requirements of
§493.1449 of this subpart and provides technical
supervision in accordance with §493.1451 of this
subpart.

technical supervisor was not met. Two of three
experience requirement in one or more
specialties/subspecialties (see 06111), and the
technical supervisors failed to ensure the
establishment of performance specifications for
the Theranos Proprietary System (TPS) were
complete and followed the laboratory's procedure
(see 06115).
D6111 2/12/16
QUALIFICATIONS The lab has corrected this issue by
ensuring that all of its technical
(a) The technical supervisor must possess a supervisors meet the training and
current license issued by the State in which the experience requirements. The new lab
laboratory is located, if such licensing is required; director is the technical supervisor for
and
(b) The laboratory may perform anatomic and chemistry, hematology, and
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PRINTED: 01/25/2016
COMPLETED
{!!Ii!> AND PLAN OF CORRECTION IDENTIFICATION NUMBER:
A. BUILDING
0502025714 B.WING 11/20/2015 ·

7333 GATEWAY BLVD
THERANOSINC
NEWARK, CA 94560
TAG TAG
DEFICIENCY)
D6111 (continued)
immunohematology. CMS already
specialties and subspecialties of services except
qualified the lab's other technical
histocompatibility and clinical cytogenetics
services provided the individual functioning as the supervisor for microbiology and
technical supervisor-- diagnostic immunology.
(b)(1) Is a doctor of medicine or doctor of
osteopathy licensed to practice medicine or TS 1 and TS2 are no longer technical
osteopathy in the State in which the laboratory is supervisors for the lab. It is worth
located; and
(b)(2) Is certified in both anatomic and clinical noting, however, that CMS qualified
pathology by the American Board of Pathology or TS 1 as a technical supervisor for
the American Osteopathic Board of Pathology or chemistry and found that she was just
Possesses qualifications that are equivalent to months away from qualifying for
those required for such certification. hematology and immunology. In
(c) If the requirements of paragraph (b) of this
addition, TS2 is still endeavoring to
section are not met and the laboratory performs
tests in the subspecialty of bacteriology, the obtain documents from his former
individual functioning as the technical supervisor employers to show that he has the
must-- requisite experience (see 06111).
(c)(1 )(i) Be a doctor of medicine or doctor of
osteopathy licensed to practice medicine or The lab has completed an assessment
osteopathy in the State in which the laboratory is
located; and
(c)(1)(ii) Be certified in clinical pathology by the having the potential to be a(fected by
American Board of Pathology or the American this issue (see 06111, 06115).
Osteopathic Board of Pathology or possess
qualifications that are equivalent to those required The new lab director has approved
for such certification;· or enhanced policies and procedures
(c)(2)(i) Be a doctor of medicine, doctor of
governing personnel qualification and
osteopathy, or doctor of podiatric medicine
licensed to practice medicine, osteopathy, or defining, among other things, the
podiatry in the State in which the laboratory is education and experience
located; and requirements for a technical
(c)(2)(ii) Have at least one year of laboratory supervisor (see 06111). The new lab
training or experience, or both, in high complexity director has also approved enhanced
testing within the specialty of microbiology with a
procedures related to the
minimum of 6 months experience in high
complexity testing within the subspecialty of
bacteriology; or
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PRINTED: 01/25/2016
STATEMENT OF DEFICIENCIES {X1) PROVIDER/SUPPLIER/CLIA (X2) MULTIPLE CONSTRUCTION (X3) DATE SURVEY
0502025714 B. WING _ _ _ _ _ _ _ __
11/20/2015
7333 GATEWAY BLVD
THERANOSINC
NEWARK, CA 94560
{X4)1D SUMMARY STATEMENT OF DEFICIENCIES ID PROVIDER'S PLAN OF CORRECTION (X5)
PREFIX {EACH DEFICIENCY MUST BE PRECEDED BY FULL PREFIX {EACH CORRECTIVE ACTION SHOULD BE COMPLETION
TAG
DEFICIENCY)

D6111 (continued)
06111
establishment of performance
(c)(3)(i) Have an earned doctoral degree in a
chemical, physical, biological or clinical laboratory
specifications (see 06115). The lab
science from an accredited institution; and has conducted training on these
(c)(3)(ii) Have at least 1 year of laboratory training procedures to ensure that its practice is
or experience, or both, in high complexity testing consistent with them (see 06111 and
within the specialty of microbiology with a 06115).
bacteriology; or In addition, the lab has improved its
(c)(4)(i) Have earned a master's degree in a quality systems and procedures-
chemical, physical, biological or clinical laboratory including quality assurance review,
science or medical technology from an accredited monitoring, and audits-to prevent
institution; and recurrence (see 06111 and 06115).
(c){4)(ii) Have at least 2 years of laboratory
training or experience, or both, in high complexity
bacteriology; or
{c){5)(i) Have earned a bachelor's degree in a
chemical, physical, or biological science or
medical technology from an accredited institution;
and
(c)(5)(ii) Have at least 4 years of laboratory
bacteriology.
(d) If the requirements of paragraph (b) of this
tests in the subspecialty of mycobacteriology, the
individual functioning as the technical supervisor
must--
(d)(1 )(i) Be a doctor of medicine or doctor of
osteopathy licensed to practice medicine or
located; and
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0502025714 B. WING _ _ _ _ _ _ _ __
11/20/2015 ·
7333 GATEWAY BLVD
THERANOS INC
NEWARK, CA 94560
TAG
DEFICIENCY)

(d)(1 )(ii) Be certified in clinical pathology by the
American Board of Pathology or the American
qualifications that are equivalent to those required
for such certification; or
(d)(2)(i) Be a doctor of medicine, doctor of
osteopathy, or doctor or pediatric medicine
licensed to practice medicine, osteopathy, or
podiatry in the State in which the laboratory is
located; and
(d)(2)(ii) Have at least 1 year of laboratory training
or experience, or both, in high complexity testing
within the specialty of microbiology with a
mycobacterialogy; or
(d)(3)(i) Have an earned doctoral degree in a
science from an accredited institution; and
(d)(3)(ii) Have at least 1 year of laboratory training
mycobacteriology; or
(d)(4)(i) Have earned a master's degree in a
science or medical technology from an accredited
institution; and
(d)(4)(ii) Have at least 2 years of laboratory
mycobacteriology; or
(d)(5)(i) Have earned a bachelor's degree in a
chemical, physical or biological science or
J.:::>V NOIJ.VJi'raOdN[ !10 woaa:H&I 8:HL 1£8:CINfl ffilO.SO'K)Sia W01Itl J.d}\fiIX8: NOIJ.Vli'rnOdNI 'IVI:::>1£8:WWO:::> 'IVIJ.N8:CII!INO:::>
PRINTED: 01/25/2016
~,;: STATEMENT OF DEFICIENCIES

A. BUILDING
(X3} DATE SURVEY
COMPLETED
0502025714 B.WING 11/20/2015 .

7333 GATEWAY BLVD
THERANOSINC
NEWARK, CA 94560
(X4JID SUMMARY STATEMENT OF DEFICIENCIES ID PROVIDER'S PLAN OF CORRECTION {XS)
TAG
DEFICIENCY)

06111
and
(d)(5)(ii) Have at least 4 years of laboratory
mycobacteriology.
(e) If the requirements of paragraph (b) of this
tests in the subspecialty of mycology, the
must--
(e)(1 )(i) Be a doctor of medicine or doctor of
located; and .
(e)(1 ){ii) Be certified in clinical pathology by the
(e)(2)(i) Be a doctor of medicine, doctor of
osteopathy, or doctor of pediatric medicine
located; and
(e)(2)(ii) Have at least 1 year of laboratory training
mycology; or
(e)(3)(i) Have an earned doctoral degree in a
(e)(3)(ii) Have at least 1 year of laboratory training
or experience, or both in high complexity testing
FORM CMS-2567(02-99) Previous Versions Obsolete Event ID:W34211 FaclJity ID: CA22046272 If continuation sheet Page 94 of 121
l.:)\f NOI.LVJi\IBO!INI .!IO WOO'il'irn.!I ffill 1I'iICIN!1 ffiIO.SO'DSia WOM .LdYII'iIX'il NOI.LVJi\IBO!INI 'lVI::rnHWWO::> 'lVI.LN'iIOI.!INO::>
CONFIDENTIAL COMJ\1ERCIAL INFORMATION EXEMPT FROM DISCLOSURE UNDER THE FREEDOM OF INFORMATION ACT
PRINTED: 01/25/2016
0502025714 B. WING _ _ _ _ _ _ _ __
11/20/2015 .
7333 GATEWAY BLVD
THERANOSINC
NEWARK, CA 94560
TAG TAG
DEFICIENCY)

mycology; or
(e)(4)(i) Have earned a master's degree in a
institution; and
(e)(4)(ii) Have at least 2 years of laboratory
mycology; or
(e)(5)(i) Have earned a bachelor's degree in a
and
(e)(5)(ii) Have at least 4 years of laboratory
mycology.
(f) If the requirements of paragraph (b) of this
tests in the subspecialty of parasitology, the
must--
(f)(1 )(i) Be a doctor of medicine or a doctor of
located; and
(f)(1 )(ii) Be certified in clinical pathology by the
(f)(2)(i) Be a doctor of medicine, doctor of
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0502025714 B. WING _ _ _ _ _ _ _ __
11 /20/2015 .
7333 GATEWAY BLVD
THERANOSINC
NEWARK, CA 94560
DEFICIENCY)

located; and
(f)(2)(ii) Have at least one year of laboratory
parasitology;
(f){3)(i) Have an earned doctoral degree in a
{f)(3)(ii) Have at least 1 year of laboratory training
complexity testing withhthe subspecialty of
parasitology; or
(f)(4){i) Have earned a master's degree in a
institution; and
(f)(4)(ii) Have at least 2 years of laboratory
parasitology; or
(f)(5)(i) Have earned a bachelor's degree in a
and
(f)(5)(ii) Have at least 4 years of laboratory
J.:)\f NOI.LVW'RO.!INI .m womiffiltl 31:I.L 1£8:CINfl ffiiflSO'DSia W01£tl ldWHXH NOU.VW'RO.!INI 'IVI::nrawwoo 'IVI.LNHGitlNOO
CONFIDENTIAL COMMERCIAL INFORMATION EXElvIPT FROM DISCLOSURE UNDER THE FREEDOM OF INFORMATION ACT
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A. BUILDING
0502025714 B.WING 11/20/2015

7333 GATEWAY BLVD
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NEWARK, CA 94560
TAG
DEFICIENCY)

parasitology.
(g) If the requirements of paragraph (b) of this
tests in the subspecialty of virology, the individual
functioning as the technical supervisor must--
(g)(1 )(i) Be a doctor of medicine or doctor of
located; and
(g)(1 )(ii) Be certified in clinical pathology by the
(g){2){i) Be a doctor of medicine, doctor of
. osteopathy, o~ doctor of pediatric medicine
located; and
(g)(2)(ii) Have at least 1 year of laboratory training
virology; or
(g)(3){i) Have an earned doctoral degree in a
(g)(3)(ii) Have at least 1 year of laboratory training
virology; or
(g)(4)(i) Have earned a master's degree in a
institution; and
FORM CMS-2567(02-99) Previous Versions Obsolete Event ID:W34211 Facility ID: CA22046272 If continuation ·sheet Page 97 of 121
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PRINTED: 01/25/2016
STATEMENT OF DEFICIENCIES (X1) PROVIDERJSUPPLIER/CLIA (X2) MULTIPLE CONSTRUCTION (X3) DATE SURVEY
~Ir. AND PLAN OF CORRECTION IDENTIFICATION NUMBER:

A. BUILDING
COMPLETED
0502025714 B.WING 11/20/2015

7333 GATEWAY BLVD
THERANOSINC
NEWARK, CA 94560
TAG
DEFICIENCY)

(g)(4)(ii) Have at least 2 years of laboratory
virology; or
(g)(5)(i) Have earned a bachelor's degree in a
and
(g)(5)(ii) Have at least 4 years of laboratory
virology.
(h) If the requirements of paragraph (b) of this
tests in the specialty of diagnostic immunology,
the individual functioning as the technical
supervisor must-
(h )( 1)(i) Be a doctor of medicine or a doctor of
located; and
(h)(1 )(ii) Be certified in clinical pathology by the
(h)(2)(i) Be a doctor of medicine, doctor of
located; and
(h)(2)(ii) Have at least 1 year of laboratory training
for the specialty of diagnostic immunology; or
FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: W34211 Facility ID; CA22046272 If continuation sheet Page 98 of 121
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PRINTED: 01/25/2016
ant
\@Y
COMPLETED
A. BUILDING _ _ _ _ _ _ __
0502025714 B. WING _ _ _ _ _ _ _ __
11/20/2015
7333 GATEWAY BLVD
THERANOSINC
NEWARK, CA 94560
TAG TAG
DEFICIENCY)
(continued; see below)

(h)(3)(i) Have an earned doctoral degree in a
(h)(3)(ii) Have at least 1 year of laboratory training
within the specialty of diagnostic immunology; or
(h)(4)(i) Have earned a master's degree in a
institution; and
(h)(4)(ii) Have at least 2 years of laboratory
testing for the specialty of diagnostic immunology;
or
(h)(5)(i) Have earned a bachelor's degree in a
. chemical, physical or biological science or
medical technblogy from an accredited institution;
and
(h)(5)(ii) Have at least 4 years of laboratory
testing for the specialty of diagnostic immunology.
(i) If the requirements of paragraph (b) of this
tests in the specialty of chemistry, the individual
(i)(1 )(i) Be a doctor of medicine or doctor of
located; and
(i)(1 )(ii) Be certified in clinical pathology by the
(i)(2)(i) Be a doctor of medicine, doctor of
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PRINTED: 01/25/2016
JSTATEMENT OF DEFICIENCIES (X1) PROVIDER/SUPPLIER/CUA (X2) MULTIPLE CONSTRUCTION (X3) DATE SURVEY
~:11:;1
1 AND PLAN OF CORRECTION IDENTIFICATION NUMBER: A. BUILDING _ _ _ _ _ _ __ COMPLETED
0502025714 8. WING _ _ _ _ _ _ _ __
11/20/2015
7333 GATEWAY BLVD
THERANOS INC
NEWARK, CA 94560
TAG
DEFICIENCY)

located; and
(i)(2)(ii) Have at least 1 year of laboratory training
for the specialty of chemistry; or
(i)(3)(i) Have an earned doctoral degree in a
(i)(3)(ii) Have at least 1 year of laboratory training
within the specialty of chemistry; or
(i)(4)(i) Have earned a master's degree in a
institution; and
(i)(4)(ii) Have at least 2 years of laboratory
training or exp~rience, or both, in high complexity
testing for the specialty of chemistry; or
(i)(5)(i) Have earned a bachelor's degree in a
and
(i)(5)(ii) Have at least 4 years of laboratory
testing for the specialty of chemistry.
0) If the requirements of paragraph (b) of this
tests in the specialty of hematology, the individual
0)(1 )(i) Be a doctor of medicine or a doctor of
located; and
0)(1 )(ii) Be certified in clinical pathology by the
0)(2)(i) Be a doctor of medicine, doctor of
J.:::>V NOIJ.YmOdNI tlO woagffihl 'iIH.L 1IlICINfl ffilflSO'I:::>Sia wou J.dw:HXlI NOIJ.YmOdNI 'IVI:::>~o:::> 'IVI.LNlIGitlNO:::>
PRINTED: 01/25/2016
CENTERS FOR MEDICARE & MEDICAID SERVICES OMS NO 0938-0391
0502025714 B. WING _ _ _ _ _ _ _ __
11 /20/2015 ·
7333 GATEWAY BLVD
THERANOS INC
NEWARK, CA 94560
PREFIX (EACH DEFICIENCY MUST BE PRECEDED BY FULL PREFIX {EACH CORRECTJVEACTION SHOULD BE COMPLETION
TAG TAG
DEFICIENCY)

located; and
G)(2)(ii) Have at least one year of laboratory
testing for the specialty of hematology (for
example, physicians certified either in hematology
or hematology and medical oncology by the
American Board of Internal Medicine); or
G)(3)(i) Have an earned doctoral degree in a
(j)(3)(ii) Have at least 1 year of laboratory training
within the specialty of hematology; or
(j)(4)(i) Have earned a master's degree in a
institution; and
(j)(4)(ii) Have at least 2 years of laboratory
testing for the specialty of hematology; or
(j)(5)(i) Have earned a bachelor's degree in a
and
(j)(5)(ii) Have at least 4 years of laboratory
testing for the specialty of hematology.
(k)(1) lf the requirements of paragraph (b) of this
tests in the subspecialty of cytology, the individual
(k)(1 )(i) Be a doctor of medicine or a doctor of
located; and
FORM CMS-2567(02-99) Previous Versions Obsolete Event ID:W34211 Faclllty ID: CA22046272 If continuation 'sheet Page 101 of 121
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0502025714 B. WING _ _ _ _ _ _ _ __
11/20/2015
7333 GATEWAY BLVD
THERANOSINC
NEWARK, CA 94560
TAG TAG
DEFICIENCY)

(k)(1 )(ii) Meet one of the following
requirements--
(k)(1 )(ii)(A) Be certified in anatomic pathology by
the American Board of Pathology or the American
(k)(1 )(ii)(B) Be certified by the American Society
of Cytology to practice cytopathology or possess
for such certification;
(I) If the requirements of paragraph (b) of this
tests in the subspecialty of histopathology, the
individual fun.ctioning as the technical supervisor
must--
(1)(1) Meet one of the following requirements:
(1)(1 )(i){A) Be a doctor of medicine or a doctor of
located; and
{1)(1 ){i){B) Be certified in anatomic pathology by
the American Board of Pathology or the American
for such certification;
{1)(1 ){ii) An individual qualified under
§493.1449(b) or paragraph (1)(1) of this section
may delegate to an individual who is a resident in
a training program leading to certification
specified in paragraph {b) or {1)(1 )(i){B) of this
section, the responsibility for examination and
interpretation of histopathology specimens.
(1)(2) For tests in dermatopathology, meet one of
the following requirements:
(1){2)(i)(A) Be a doctor of medicine or doctor of
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0502025714 B. WING _ _ _ _ _ _ _ __
11/20/2015
7333 GATEWAY BLVD
THERANOS INC
NEWARK, CA 94560
TAG TAG
DEFICIENCY)

located and--
(1)(2) (i)( B) Meet one of the following
requirements:
(1)(2)(i)(B)(1) Be certified in anatomic pathology
by the American Board of Pathology or the
American Osteopathic Board of Pathology or
possess qualifications that are equivalent to those
required for such certification; or
(1)(2)(i)(B)(2) Be certified in dermatopathology by
the American Board of Dermatology and the
American Board of Pathology or possess
(1)(2)(i)(B)(3) Be certified in dermatology by the
American Board of Dermatology or possess
qualifications t.hat are equivalent to those required
(1)(2)(ii) An individual qualjfied under
§493.1449(b) or paragraph (1)(2)(i) of this section
specified in paragraphs (b) or (1)(2)(i)(B) of this
interpretation of dermatopathology specimens.
(1)(3) For tests in ophthalmic pathology, meet
one of the following requirements:
(1)(3)(i)(A) Be a doctor of medicine or doctor of
located and--
(1)(3)(i)(B) Must meet one of the following
requirements:
(1)(3)(i)(B)(1) Be certified in anatomic pathology
by the American Board of Pathology or the
American Osteopathic Board of Pathology or
possess qualifications that are equivalent to those
required for such certification; or
(1)(3)(i)(B){2) Be certified by the American Board
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PRINTED: 01/25/2016
0502025714 B. WING _ _ _ _ _ _ _ __
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REGULATORY OR LSC IDENTIFYING INFORMATION) CROSS-REFERENCED'TO THE APPROPRIATE DATE
TAG TAG
DEFICIENCY)

of Ophthalmology or possess qualifications that
are equivalent to those required for such
certification and have successfully completed at
least 1 year of formal post-residency fellowship
training in ophthalmic pathology; or
(1)(3)(ii) An individual qualified under
§493.1449(b) or paragraph (1 )(3){i) of this section
specified in paragraphs (b) or (1 )(3)(i)(B) of this
interpretation of ophthalmic specimens; or
(m) If the requirements of paragraph (b) of this
tests in the subspecialty of oral pathology, the
must meet one of the foHowing requirements:
(m)(1 )(i) Be a doctor of medicine or a doctor of
located and--
(m)( 1)(ii) Be certified in anatomic pathology by the
(m)(2) Be certified in oral pathology by the
American Board of Oral Pathology or possess
qualifications for such certification; or
(m)(3) An individual qualified under §493.1449(b)
or paragraph (m)(1) or (2) of this section may
delegate to an individual who is a resident in a
training program leading to certification specified
in paragraphs {b) or (m)(1) or (2) of this section,
the responsibility for examination and
interpretation of oral pathology specimens.
{n) If the requirements of paragraph (b) of this
J.:::>V NOIJ.VJi\raOifNI iIO WOCT'iI':n!II 3lll 1I'iIC£NC1 ffiID.SO'DSICT W01III J.dli'II'iIX'iI NOIJ.VJi\raOifNI 'IVI:::>1IHWWO:::> 'IVIJ.N'iIGHNO:::>
PRINTED: 01/25/2016
0502025714 B. WING _ _ _ _ _ _ _ __
11/20/2015
7333 GATEWAY BLVD
THERANOSINC
NEWARK, CA 94560
TAG TAG
DEFICIENCY)

tests in the specialty of radiobioassay, the
must--
(n)(1 )(i) Be a doctor of medicine or a doctor of
located; and
(n)(1 )(ii) Be certified in clinical pathology by the
(n)(2)(i) Be a doctor of medicine, doctor of
located; and
(n)(2)(ii) Have at least 1 year of laboratory training
for the specialty of radiobioassay; or
(n)(3)(i) Have an earned doctoral degree in a
(n)(3)(ii) Have at least 1 year of laboratory training
within the specialty of radiobioassay; or
(n)(4)(i) Have earned a master's degree in a
institution; and
(n)(4)(ii) Have at least 2 years of laboratory
testing for the specialty of radiobioassay; or
(n)(5)(i) Have earned a bachelor's degree in a
and
(n)(5)(ii) Have at least 4 years of laboratory
PRINTED: 01/25/2016
cn.J. STATEMENT OF DEFICIENCIES
t:::/;{AND PLAN OF CORRECTION
COMPLETED
A. BUILDING _ _ _ _ _ _ __
<2:r·
0502025714 B. WING _ _ _ _ _ _ _ __
11/20/2015
7333 GATEWAY BLVD
THERANOS INC
NEWARK, CA 94560
DEFICIENCY)

testing for the specialty of radiobioassay.
(o) If the laboratory performs tests in the specialty
of histocompatibility, the individual functioning as
the technical supervisor must either--
(o)(1 )(i) Be a doctor of medicine, doctor of
located; and
(o)(1)(ii) Have training or experience that meets
one of the following requirements:
(o)(1 )(ii)(A) Have 4 years of laboratory training or
experience, or both, within the specialty of
histocompatibility; or
(o)(1 )(ii)(B)(1) .Have 2 years of laboratory training
or experience, or both, in the specialty of general
immunology; and
(o)(1)(ii)(B)(2) Have 2 years of laboratory training
or experience, or both, in the specialty of
(o)(2)(i) Have an earned doctoral degree in a
biological or clinical laboratory science from an
accredited institution; and
(o)(2)(ii) Have training or experience that
meets one of the following requirements:
(o)(2)(ii)(A) Have 4 years of laboratory training or
experience, or both, within the specialty of
or experience, or both, in the specialty of general
immunology; and
or experience, or both, in the specialty of
histocompatibility.
(p) If the laboratory performs tests in the specialty
of clinical cytogenetics, the individual functioning
as the technical supervisor must--
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CONFIDENTIAL COMMERCIAL INFORMATION EXEJMPT FROM DISCLOSURE UNDER THE FREEDOM OF JNFORMATION ACT
PRINTED: 01/25/2016
~,111: A. BUILDING
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7333 GATEWAY BLVD
THERANOSINC
NEWARK, CA 94560
TAG TAG
DEFICIENCY)

(p)(1)(i) Be a doctor of medicine, doctor of·
located; and
(p)(1 )(ii) Have 4 years of training or experience,
or both, in genetics, 2 of which have been in
clinical cytogenetics; or
(p)(2)(i) Hold an earned doctoral degree in a
biological science, including biochemistry, or
clinical laboratory science from an accredited
institution; and
(p)(2)(ii) Have 4 years of training or experience,
or both, in genetics, 2 of which have been in
clinical cytogenetics.
(q) If the requirements of paragraph (b) of this
tests in the specialty of immunohematology, the
must--
(q)(1)(i) Be a doctor of medicine or a doctor of
located; and
(q)(1 )(ii) Be certified in clinical pathology by the
Note: The technical supervisor requirements for

"laboratory training or experience, or both" in
each specialty or subspecialty may be acquired
concurrently in more than one of the specialties or
subspecialties of service. For example, an
individual, who has a doctoral degree in chemistry
and additionally has documentation of 1 year of
laboratory experience working concurrently in
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CONFIDENTIAL COiv.IMERCIAL INFORMATION EXEMPT FROM DISCLOSURE UNDER THE FREEDOM OF INFORMATION ACT
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0502025714 B. WING _ _ _ _ _ _ _ __
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7333 GATEWAY BLVD
THERANOSINC
NEWARK, CA 94560
(X4)10 SUMMARY STATEMENT OF DEFICIENCIES ID PROVIDER'S PLAN OF CORRECTION (XS)
TAG TAG
DEFICIENCY)

high complexity testing in the specialties of
microbiology and chemistry and 6 months of that
work experience included high complexity testing
in bacteriology, mycology, and mycobacteriology,
would qualify as the technical supervisor for the
specialty of chemistry and the subspecialties of
bacteriology, mycology, and mycobacteriology.

Based on review of training documentation, two
of three technical supervisors failed to have the
required 4 years of training or experience, or
both, in a specialty or subspecialty as required to
qualify as a technical supervisor. Findings
include:
a. Training documents from the personnel file

for three technical supervisors were reviewed.
b. Technical Supervisor #1 (TS1) and the

QA/QC Manager stated that all training
documentation was kept in the personnel file for
each employee.
c. TS1 was unable to provided documentation

which showed 4 years of training and/or
experience in high complexity testing for
hematology or immunology.
d. Technical Supervisor #2 (TS2) was unable to

provided documentation which showed 4 years of
training and/or experience in high complexity
testing for hematology, chemistry or immunology.
e. TS1 confirmed on 9/23/2015 at 10:30 am that

the documentation did not show the required
training or experience in immunology and
hematology for TS1.
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PRINTED: 01/25/2016
CENTERS FOR MEDICARE & MEDICAID SERVICE:S OMB NO 0938-0391
&Et. STATEMENT OF DEFICIENCIES (X1) PROVIDER/SUPPLIER/CLIA (X2) MULTIPLE CONSTRUCTION (X3) DATE SURVEY
\{M> AND PLAN OF CORRECTION IDENTIFICATION NUMBER: A BUILDING _ _ _ _ _ _ __ COMPLETED
0502025714 B. WING _ _ _ _ _ _ _ __
11/20/2015
7333 GATEWAY BLVD
THERANOSINC
NEWARK, CA 94560
TAG
DEFICIENCY)
f. TS2 confirmed on 11/18/2015 at

approximately 9:50 am that the documentation
did not show the required training or experience
in hematology, chemistry or immunology for TS2.
06115 493.1451(b)(2) TECHNICAL SUPERVISOR 06115 D6115 2/12/16
RESPONSIBILITIES The lab has completed an assessment
The technical supervisor is responsible for
verification of the test procedures performed and having the potential to be affected by
establishment of the laboratory's test this issue.
performance characteristics, including the
precision and accuracy of each test and test The lab's management, including the
system. new lab director and newly appointed
Based on review of validation documents on the
Theranos Proprietary System (TPS), the technical ensuring that technical supervisors are
supervisor failed to ensure that the validation effective in supervising method
procedures performed on the TPS established verification and validation procedures.
performance specifications for accuracy, The lab will further ensure that these
precision, reportable range, and/or reference procedures are effective through
range and failed to ensure establishment of the
performance specifications followed the
oversight during monthly QA
laboratory's procedures. Findings include: meetings. In addition, the lab will
monitor the implementation of these
a. Validations Reports for Vitamin D (Vito), Total procedures through audits performed
T3 (TT3), Human Chorionic Gonadotropin (HCG), pursuant to the lab's new audit
and Sex Hormone Binding Globulin (SHBG) were
procedures.
reviewed.
b. The laboratory presented the procedure, CL

for Routine Chemistry Assays on Theranos
Devices," when the surveyor requested their
procedure for establishing performance
specifications.
c. Vito, HCG, and SHBG validation reports
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~;;/:: STATEMENT OF DEFICIENCIES

A. BUILDING
(X3) DATE SURVEY
COMPLETED
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TAG TAG
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included "Theranos-corrected" results without an
explanation as to how the "Theranos Result" was
corrected or which result was reported.
d. The procedure requires in Section 4.1 that

the laboratory director (LO) ensures that the
chemistry assays are qualified and validated
according to the procedure.
e. The validation report for SHBG had an

effective date of 7/14/14 but was not signed by
the LD until 9/19/15. SHBG testing was
performed on the TPS from 7/28/14 through
6/24/15.
',
Accuracy
a. The procedure required in Section 16 that the

samples used to calculate accuracy were to cover
the entire reportable range, samples were to be
run in at least 2 replicates, and 50% of samples
were to be outside the reference range.
b. Vito, TT3, HCG, and SHBG reports all

indicated that the predicate method was
performed in duplicate, but did not indicate if TPS
samples were run in duplicate.
c. TT3 had a reportable range of 47.6-1420

ng/dL however the accuracy data only covered
the range of 42.8-350 ng/dl.
d. The laboratory used a total of 148 specimens

to perform the accuracy study for SHBG. Of the
148 specimens only six (4%) were outside the
reference range. 50% of the specimens were not
outside the reference range as required.
Precision
J.;)V NOI.LVli'rnOtlNI .!IO woaa:ffiu! HHL 113:CINfl ffilflSO'I::>Sia W01Itl J.dWHXH NOIJ.Vli'raOtlNI 'JVI:)1Ia:WWO::> 'IVI.LNHaitlNO;)
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{ff) STATEMENT OF DEFICIENCIES (X1) PROVIDER/SUPPLIER/CLIA {X2) MULTIPLE CONSTRUCTION (X3) DATE SURVEY
\@}; AND PLAN OF CORRECTION IDENTIFICATION NUMBER: A. BUILDING _ _ _ _ _ _ __ COMPLETED
0502025714 B. WING _ _ _ _ _ _ _ __
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samples used to calculate precision were to cover
the entire reportable range, include data from the
familiarization study, include at least 1 quality
control sample, have study performed over 20
operating days, and have a CV% less than or
equal to 15% (less than or equal to 20% at the
lower and upper level of detection).
b. Vito, TT3, HCG, and SHBG reports revealed

that none of the precision studies covered 20
operating days.
c. Vito and TT3 reports revealed that the

precision study did not cover the entire reportable
range.
d. Vito, TT3, HCG, and SHBG reports did not

document that the familiarization data was used
in the validation report and did not document 1
level of quality control was included in the study.
e. Vito precision data showed that two of three

levels (15, 33.5 ng/ml) used showed a CV%
greater than 20% and 15% respectively.
f. TT3 precision data showed that two of three

levels (85, 109 ng/dl) used showed a CV%
greater than 15%.
g. SHBG precision revealed that 47 of 96

samples had %CV greater than 20%.
Reportable Range

samples used to calculate reportable range were
to cover the entire reportable range.
PRINTED: 01/25/2016
(X1) PROVIDER/SUPPLIER/CUA (X2) MULTIPLE CONSTRUCTION (X3) DATE SURVEY
IDENTIFICATION NUMBER: A. BUILDING _ _ _ _ _ _ __ COMPLETED
0502025714 B. WING _ _ _ _ _ _ _ __
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7333 GATEWAY BLVD
THERANOS INC
NEWARK, CA 94560
DEFICIENCY)

b. The validation report for VitD stated that the

reportable range was 10-150 ng/mL. Samples
tested covered a range of 14.17-108.25 ng/mL.
c. The validation report for TT3 stated that the

reportable range was 47.6-1420 ng/dL. Samples
tested covered a range of less than 40-266 ng/dL.
d. The validation report for SHBG stated that

the reportable range was 2.5-200 nM. Samples
tested covered a range of 2.4-106 nM.
e. The validtion report for SHBG also stated that

the R2 value for the dilution linearity should be
equal to or grE1ater than 0.95. However, the
valuation report states on page 46 that "Two of
the seven samples did no.t meet the optimal
percent recovery and show slighty higher %
recovery than the upper desired limit, however
the R2 value of 0.92 seems very compariable to
the 0.95 acceptance value."
Reference Range

reference range data should include " ... a
minimum of 120 samples for each partition. For
instance, if a reference interval needs partitions
for gender, then samples from 120 men and 120
women will be needed."
b. Reference range data for VitD, TT3, and

HCG included 20 samples.
c. Reference range data for SHBG included 14

samples from females and 10 samples from
males.
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t[;l!l STATEMENT OF DEFICIENCIES

A BUILDING
(X3) DATE SURVEY
COMPLETED
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TAG
DEFICIENCY)
06115 Continued From page 112 06115 ( continued; see above)

Percent(%) Recovery
a. The laboratory validation reports required a

Recovery Rate of 100 +/- 20% (100 +/- 25% at
the upper limit and lower limit of reportable range)
for VitD, TT3, and SHBG.
b. The "Clinical Correlation (Historical)" table,

Table 7, for Vito revealed that twelve (12) of
twenty nine (29) samples showed a % Recovery
greater than +/- 20%. Ten (10) of the 12 samples
had a % Recovery greater than +/- 25%. Of
these 10 samples, eight of ten were not at the
upper or lower limit of the reportable range.
c. The "Clinical Correlation (Historical)" table,

Table 8, for Vito revealed that twenty eight (28) of
eighty one (81) samples showed a % Recovery
greater than +/- 20%. Twenty (20) of the 28
samples had a % Recovery greater than +/- 25%.
Of these 28 samples, seventeen (17) of twenty
eight (28) were not at the upper or lower limit of
the reportable range.
d. The "Clinical Correlation and Bias Correction"

table, Table 6, for TT3 revealed that thirty six (36)
of one hundred and seven (107) samples
showed a % Recovery greater than +/- 20%.
Twenty four (24) of the 36 samples had a %
Recovery greater than +/- 25%. Of these 36
samples, 23 of 36 were not at the upper or lower
limit of the reportable range.
e. The "Dilution Linearity" table, Table 21, for

SHBG revealed that the 1:2 dilution (nominal
value= 53.4 nM) had a% Recovery of 131% and
the 1:64 dilution (nominal value 2.4 nM) had a %
Recovery of 150%. The laboratory's reportable
range for SHBG was 2.5-200 nM.
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PRINTED: 01/25/2016
(X1) PROVIDER/SUPPLIER/CUA (X2) MULTIPLE CONSTRUCTION (X3) DATE SURVEY
f'_,.·:. .~_STATEMENT OF DEFICIENCIES
•._'":,.:,.·.',.'·:·',t:J
\· ·.x'°''' AND PLAN OF CORRECTION IDENTIFICATION NUMBER: A. BUILDING _ _ _ _ _ _ __ COMPLETED
j:>•
0502025714 8. WING _ _ _ _ _ _ _ __
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NEWARK, CA 94560
TAG
DEFICIENCY)
( continued; see above)

f. The "Summary of normal patient samples for

Reference Range" table, Table 24, for SHBG
revealed that ten (10) of fourteen (14) samples
for females and nine (9) of ten (10) samples for
males showed a % Recovery greater than +/-
20%. Fourteen (14) of the twenty four (24) total
samples had a % Recovery greater than +/- 25%.
Of these 24 samples, 24 of 24 were not at the
upper or lower limit of the reportable range.
Allowable Bias
a. The Alternative Assessment Program

procedure stated that allowable bias between a
predicate metbod and the Theranos Proprietary
System (TPS) was equal to or less than 20%.
b. The terms Total Allowable Error and

Allowable Bias seemed to be used
interchangably.
c. The formula used to determine allowable bias

was: Laboratory value minus the Predicate value
divided by Predicate value (Laboratory value -
Predicate value/Predicate value).
d. Nine random samples (01, 20, 30, 41, 91, 32,

74, H2, H58) were reviewed from the Vito clinical
correlation studies (Table 7 and 8) from the
validation report. The allowable bias calculation
for these nine samples ranged from 21-130%.
The reference ranges for both the Predicate
method and the TPS were the same for Vito.
e. Nine random samples (2, 60, 62, 18, 57, 43,

68, 73, 92) were reviewed from the TT3 clinical
correlation study {Table 6) from the validation
report. The allowable bias calculation for these
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CONFIDENTIAL COrv.t:MERCIAL INFORMATION EXEMPT FROM DISCLOSURE UNDER THE FREEDOM OF INFORMATION ACT
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tfa:) STATEMENT OF DEFICIENCIES (X1) PROVIDER/SUPPLIER/CLIA (X2) MULTIPLE CONSTRUCTION {X3) DATE SURVEY
lz:@f AND PLAN OF CORRECTION IDENTIFICATION NUMBER: A BUILDING _ _ _ _ _ _ __ COMPLETED
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DEFICIENCY)

nine samples ranged from 21-39%. The
reference ranges for both the Predicate method
and the TPS were the same for TT3.
f. Nine random samples (5, 8, 25, 36, 54, 74,

76, 131, 145) were reviewed from the SHBG
clinical correlation study (Table 20) from the
validation report. The allowable bias calculation
for these nine samples ranged from 22-146%.
The reference ranges for both the Predicate
method and the TPS were the same for SHBG.
06124 493.1451 (b)(8)(iv) TECHNICAL SUPERVISOR 06124 D6124 2/12/16
RESPONSIBILITIES All testing personnel currently
performing tests have completed
The procedures for evaluation of the competency
of the staff mast include, but are not limited to
competency testing with direct
direct observation of performance of instrument observation of, among other things,
maintenance and function checks. maintenance and function checks for
This STANDARD is not met as evidenced by: the tests they are performing.
Based on review of the 2015 competency
assessment form and interview, the technical The lab has completed an assessment
supervisor failed to include direct observations of
performance of instrument maintenance and to identify any patients affected or
function checks in competency assessment. having the potential to be affected by
Findings include: this issue.
a. Competency Assessment form, CL The laboratory management, including

FRM-0316-F59, stated the following: "Review
the new lab director and newly
documentation of assigned instrument
maintenance and function checks as applicable." appointed quality director, will ensure
that technical supervisors follow
b. Testing personnel and the technical required procedures, including
supervisor stated on 9/23/15 at approximately personnel procedures. The lab will
1:30 pm that instrument maintenance and further assure the adequacy and
function check documention was reviewed as
competency of staff during monthly
part of annual competency assessment and that
direct obervation of these activities was not QA meetings. In addition, the lab will
performed.
.L::>V NOI.LVJ'lraOd.NI iIO WOOHffiIII ffill 1!8:CIN.Cl ffilflSO'J::>SIO W01III .LdWHXH NOI.LVJ'lraOdNI 'IVI::>1!8:WWO::> 'IVI.LNHOIIINO::>
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06168 493.1487 TESTING PERSONNEL 06168

D61~4 (con~inued) .
momtor the rmplementat10n of these
The laboratory has a sufficient number of procedures through audits performed
individuals who meet the qualification pursuant to the lab's new audit
requirements of procedures.
§493.1489 of this subpart to perform the functions
specified in §493.1495 of this subpart for the
volume and complexity of testing performed.
that technical supervisors implement
This CONDITION is not met as evidenced by: and monitor the lab's enhanced
Based on the number and severity of the training and competency procedures.
deficiencies cited herein, the Condition: These procedures require, among
other things, direct observation of
testing personnel was not met. The laboratory
failed to have qualified testing personnel
instrument maintenance and function
performing high complexity testing. Refer to checks in competency assessments.
06170 and 06171. The lab has conducted training on
..· 06170 493.1489(a) TESTING PERSONNEL 06170 these procedures to ensure that
QUALIFICATIONS practice is consistent with them.
Each individual performing high complexity
testing must possess a current license issued by
the State in which the laboratory is located, if
such licensing is required.
WBC differential record review on November 17,
2015, each individual performing high complexity
WBC differential testing failed to possess a
current license issued by the State of California.
Findings included:
a. For patient capillary specimens, it was the

WBC differentials.
b. Between June 1, 2015 and September 21,

2015, California unlicensed testing personnel
reviewed and released patient flow cytometry
.L:)V NOI.LVW1IOtlN[ .m woaa:'inLI filI.L 118:ClNO. ffililSO'DSia WO&! .LcIWa:xa: NOI.LVW1£0tlN[ 'JVI:)~0:) 'IVI.LN8:GidN0:)
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dO> STATEMENT OF DEFICIENCIES (X1) PROVIDER/SUPPLIER/CUA (X2) MULTIPLE CONSTRUCTION (X3) DATE SURVEY
\lMff AND PLAN OF CORRECTION IDENTIFICATION NUMBER:
A. B U I L D I N G - - - - - - - -
COMPLETED
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NEWARK, CA 94560
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DEFICIENCY)
D6168: 2/12/16
The lab has corrected this issue by
The laboratory has a sufficient number of ensuring that all of its testing
individuals who meet the qualification personnel who perform high
requirements of complexity testing are qualified, with
§493.1489 of this subpart to perform the functions strict adherence to the regulatory
requirements (see D6170, D6171).
This CONDITION is not met as evidenced by: The lab has completed an assessment
Based on the number and severity of the to identify any patients affected or
deficiencies cited herein, the Condition: having the potential to be affected by
Laboratories performing high complexity testing; this issue (see D6170, D6171).
performing high complexity testing. Refer to The new lab director has approved
06170 and 06171. enhanced policies and procedures
06170 493.1489(a) TESTING PERSONNEL 06170 governing personnel qualification and
QUALIFICATIONS defining, among other things, the
responsibilities of licensed and
unlicensed personnel, respectively.
the State in which the laboratory is located, if The lab has conducted training on
such licensing is required. these procedures to ensure that its
This STANDARD is not met as evidenced by: practice is consistent with them (see
Based on laboratory personnel interviews and 06170 and 06171).
WBC differential testing failed to possess a In addition, the lab has improved its
current license issued by the State of California. quality systems and procedures-
Findings included: including quality assurance review,
monitoring, and audits-to prevent
a. For patient capillary specimens, it was the recurrence (see 06170 and 06171).
WBC differentials.
b. Between June 1, 2015 and September 21,

2015, California unlicensed testing personnel
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The laboratory has a sufficient number of

individuals who meet the qualification
requirements of
§493.1489 of this subpart to perform the functions

performing high complexity testing. Refer to
06170 and 06171.
06170 493.1489(a) TESTING PERSONNEL 06170 D6170: 2/12/16
QUALIFICATIONS The lab has reviewed its personnel
files to ensure testing personnel satisfy
the educational and experiential
the State in which the laboratory is located, if requirements.
such licensing is required.
This STANDARD is not met as evidenced by: The lab proactively paused WBC
Based on laboratory personnel interviews and tests, including manual differentials.
WBC differential testing failed to possess a The lab has completed an assessment
current license issued by the State of California. to identify any patients affected or
Findings included: having the potential to be affected by
this issue.
a. For patient capillary specimens, it was the
practice of the laboratory to use flow cytometry The new lab director has approved
WBC differentials. enhanced procedures to ensure that all
testing personnel satisfy the
b. Between June 1, 2015 and September 21, qualification requirements, including
2015, California unlicensed testing personnel the required license and education.
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er>
\J{f
(X2) MULTIPLE CONSTRUCTION (X3} DATE SURVEY
COMPLETED
A. BUILDING _ _ _ _ _ _ __
0502025714 B. WING _ _ _ _ _ _ _ __
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7333 GATEWAY BLVD
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NEWARK, CA 94560
(X4} ID SUMMARY STATEMENT OF DEFICIENCIES ID PROVIDER'S PLAN OF CORRECTION (X6)
REGULATORY OR LSC IDENTIFYING INFORMATION} CROSS-REFERENCED TO THE APPROPRIATE DATE
TAG TAG
DEFICIENCY}

~i~s:op~~::!:::~lso define, among
WBC differential scatter plots. The scatter plots
were released by California unlicensed testing other things, the responsibilities of
personnel without any further review by a licensed and unlicensed personnel,
California licensed testing person. respectively. The responsibilities and
approved activities of unlicensed
c. Between June 1, 2015 and September 21, personnel are limited, with strict
2015, the laboratory reported 2, 112 patient WBC adherence to regulatory requirements,
differential performed using the flow cytometry
instrumentation. and may only be performed under the
06171 493.1489(b) TESTING PERSONNEL 06171 direct supervision oflicensed
QUALIFICATIONS personnel. The lab has conducted
training on these procedures to ensure
(b) Meet one of the following requirements: that its practice is consistent with
(b)(1) Be a doctor of medicine, doctor of them.
podiatry in the State in which the laboratory is The laboratory management, including
located or have earned a doctoral, master's or the new lab director and newly
bachelor's degree in a chemical, physical, appointed quality director, is
biological or clinical laboratory science, or responsible for ensuring that practice
medical technology from an accredited institution; is consistent with these procedures.
(b)(2)(i) Have earned an associate degree in a
laboratory science, or medical laboratory The lab will further assure 11).e
technology from an accredited institution or-- adequacy and competency of staff
(b)(2)(ii) Have education and training equivalent during monthly QA meetings. In
to that specified in paragraph (b)(2)(i) of this addition, the lab will monitor the
section that includes-- implementation of these procedures
(b)(2)(ii)(A) At least 60 semester hours, or
through audits performed pursuant to
equivalent, from an accredited institution that, at a
minimum, include either-- the lab's new audit procedures.
(b)(2)(ii)(A)(1) 24 semester hours of
medical laboratory technology courses; or
(b)(2)(ii)(A)(2) 24 semester hours of
science courses that include--
(b)(2)(ii)(A)(2)(i) Six semester
hours of chemistry;
(b)(2)(ii)(A)(2)(ii) Six semester
hours of biology; and
(
\
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DEFICIENCY)

WBC differential scatter plots. The scatter plots
were released by California unlicensed testing
personnel without any further review by a
California licensed testing person.
c. Between June 1, 2015 and September 21,

2015, the laboratory reported 2, 112 patient WBC
differential performed using the flow cytometry
instrumentation.
06171 493.1489(b) TESTING PERSONNEL 06171
QUALIFICATIONS D6171: 2/12/16
TP 14 has been retrained to ensure that
(b) Meet one of the following requirements: TP14 only performs activities within
(b)(1) Be a doctor of medicine, doctor of the scope of TP14's job description as
a clinical laboratory associate, under
podiatry in the State in which the laboratory is the supervision of testing personnel.
located or have earned a doctoral, master's or Because TP14 is not testing personnel,
bachelor's degree in a chemical, physical, the high complexity personnel
biological or clinical laboratory science, or educational requirements do not apply.
(b)(2)(i) Have earned an associate degree in a
laboratory science, or medical laboratory The lab has completed an assessment
technology from an accredited institution or-- to identify any patients affected or
(b)(2)(ii) Have education and training equivalent having the potential to be affected by
to that specified in paragraph (b)(2)(i) of this this issue.
section that includes--
(b )(2)(ii)(A) At least 60 semester hours, or The new lab director has approved
equivalent, from an accredited institution that, at a
minimum, include either-- enhanced procedures to ensure that
(b)(2)(ii)(A)(1) 24 semester hours of testing personnel meet the requisite
medical laboratory technology courses; or educational qualifications. These
(b)(2)(ii)(A)(2) 24 semester hours of procedures also define, among other
science courses that include-- things, the responsibilities of licensed
(b )(2)(ii)(A)(2)(i) Six semester
and unlicensed personnel,
hours of chemistry;
(b)(2)(ii)(A)(2)(ii) Six semester respectively. The responsibilities and
hours of biology; and approved activities of unlicensed
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TAG REGULATORY OR LSC IDENTIFYING INFORMATION) CROSS-REFERENCED TO THE APPROPRIATE DATE
TAG
DEFICIENCY)
06171 Continued From page 117 D6171 (continued)

06171
personnel are limited, with strict
(b)(2)(ii)(A)(2)(iii) Twelve
semester hours of chemistry, biology, or medical adherence to regulatory requirements,
laboratory technology in any combination; and and may only be performed under the
(b)(2)(ii)(B) Have laboratory training that direct supervision of licensed
includes either of the following: personnel. The lab has conducted
(b)(2)(ii)(B)(1) Completion of a clinical laboratory training on these procedures to ensure
training program approved or accredited by the
that its practice is consistent with
ASHES, the CAHEA, or other organization
approved by HHS. (This training may be included them.
in the 60 semester hours listed in paragraph (b)
(2)(ii)(A) of this section.) The laboratory management, including
(b)(2)(ii)(B)(2) At least 3 months documented the new lab director and newly
laboratory training in each specialty in which the appointed quality director, is
individual performs high complexity testing.
(b)(3) Have previously qualified or could have responsible for ensuring that practice
qualified as a technologist under §493.1491 on or is consistent with these procedures.
before February 28, 1992; The lab will further assure the
(b)(4) On or before April 24, 1995 be a high adequacy and competency of staff
school graduate or equivalent and have either-- during monthly QA meetings. In
(b)(4 )(i) Graduated from a medical laboratory or addition, the lab will monitor the
clinical laboratory training program approved or
accredited by ABHES, CAHEA, or other implementation of these procedures
organization approved by HHS; or through audits performed PlJ!SUant to
(b)(4)(ii) Successfully completed an official U.S. the lab's new audit procedures.
military medical laboratory procedures training
course of at least 50 weeks duration and have
held the military enlisted occupational specialty of
Medical Laboratory Specialist (Laboratory
Technician);
(b)(5)(i) Until September 1, 1997--
(b)(5){i)(A) Have earned a high school
diploma or equivalent; and
(b)(5)(i){B) Have documentation of training
appropriate for the testing performed before
analyzing patient specimens. Such training must
ensure that the individual has--
(b)(5)(i)(B)(1) The skills required for proper
specimen collection, including patient preparation,
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TAG TAG
DEFICIENCY)

if applicable, labeling, handling, preservation or
fixation, processing or preparation, transportation
and storage of specimens;
(b)(5)(i){B}(2) The skills required for implementing
all standard laboratory procedures;
{b)(5)(i){B)(3) The skills required for performing
each test method and for proper instrument use;
(b)(5)(i)(B)(4) The skills required for performing
preventive maintenance, troubleshooting, and
calibration procedures related to each test
performed;
(b)(5)(i)(B)(5) A working knowledge of reagent
stability and storage;
{b){5)(i)(B)(6) The skills required to implement the
quality control policies and procedures of the
laboratory;
(b)(5)(i)(B)(7) An awareness cif the factors that
influence test results; and.
(b)(5)(i)(B)(8) The skills required to assess and
verify the validity of patient test results through
the evaluation of quality control values before
reporting patient test results; and
(b)(5)(i)(B)(8)(ii) As of September 1, 1997, be
qualified under §493.1489(b)(1), (b)(2), or (b)(4),
except for those individuals qualified under
paragraph (b)(5)(i) of this section who were
performing high complexity testing on or before
April 24, 1995;
{b){6) For blood gas analysis--
(b)(6)(i) Be qualified under §493.1489(b)(1 ),
(b)(2), (b)(3), (b)(4), or (b)(5);
(b)(6){ii) Have earned a bachelor's degree in
respiratory therapy or cardiovascular technology
from an accredited institution; or
(b)(6)(iii) Have earned an associate degree
related to pulmonary function from an accredited
institution; or
(b)(7) For histopathology, meet the qualifications
.L:::>V NOI.LVli'lrnOdNI .!IO WOO'tl3}1.!I ffi:I.L '8:'tICIN[l ffiIDSO'I:::>Sia WO~ .LdW'tIX'tI NOI.LVli'lraOdNI 'TVI:::>~O:::> 'TVI.LN'tIOI.!INO:::>
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of §493.1449 (b) or (I) to perform tissue
examinations.

Based on review of personnel documentation
and interview, one of thirty five testing personnel
(TP14)failed to meet the high complexity
personnel educational qualifications. Findings
include:
a. Review of TP14's personnel records revealed

a bachelors degree in Liberal Studies.
b. The general supervisor and technical

consultant stated that all personnel documents
were kept in the personnel records.
c. No further records were identified which

showed a bachelor's degree in a chemical,
physical, biological, clinical laboratory science or
medical technology.
06178 493.1495(b)(4) TESTING PERSONNEL
06178 D6178: 2/12/16
RESPONSIBILITIES
Each individual performing high complexity to identify any patients affected or
testing must follow the laboratory's established having the potential to be affected by
policies and procedures whenever test systems this issue.
are not within the laboratory's established
acceptable levels of performance.
This STANDARD is not met as evidenced by: The new lab director has approved
Based on laboratory personnel interviews and revised QC procedures to ensure that
complete blood counts (CBC) quality control QC is acceptable before patient results
corrective action record review on September 23, are reported. Lab personnel have been
2015, the testing personnel, high complexity trained on these procedures.
testing, failed to follow the laboratory's
established policies and procedures whenever
CBC test systems were not with the laboratory's The laboratory management, including
established acceptable levels of performance.
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D6178 (continued)
06178 Continued From page 120 06178 the new lab director and newly
Findings included: appointed quality director, is
esponsible for ensuring that practice
stated values of commercially assayed quality is consistent with these procedures. In
control materials to monitor patient CBC testing addition, the lab will monitor the
using the Drew 3 instrument. In the event any implementation of these procedures
CBC quality control material test results did not through audits performed pursuant to
fall within the stated assay values, laboratory .he lab's new audit procedures.
personnel were to follow the procedure detailed in
the protocol titled "Quality Control (document
number CL QOP-00013, revision F)."
b. Laboratory records for the Drew 3 instrument

the laboratory designated as "Drew #2" indicated
that on July 11, 12, 14, and 16, 2015 CBC quality
control mater1al test results failed to meet stated
assay values. The laboratory's documentation of
these quality control failu·res indicated that the
laboratory's "Quality Control" protocol was not
followed.
c. Laboratory records indicated that the Drew 3

instrument the laboratory designated as "Drew
#2" was used to test and report 36 patient CBC
specimens on July 14, 2015, and 45 patient CBC
specimens on July 16, 2015.
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-CON]!'JD.BN'f.rAt iJb.'.MMER.Gi¥,ll'Ili'P~~ERO:M'.D:rBOLOSfumUJ:ilt!EJ.t'I'.

c, There was no dacumenation that the

d.. The general ~upervlsorstated'tha:ttfie Quallty

e. The QC/QA.Manger confirmed .on 11/18/15

02094 Continued From page 1 02094

02128 Continued From page 2 02128

05024 Continued From page 3 05024

05217 Continued From page 4

c. According to laboratory records, the

05391 Continued From page 6 05391

05391 Continued From page 6 05391 (C onmue

2. Based on laboratory personnel interviews and

a. According to laboratory personnel, a log of

b. The laboratory maintained no written policies

05393 Continued From page 7 05393

0502025714 B.WING 11/20/2015

05400 Continued From page 8 05400

05403 Continued From page 9

a. It was the practice of the laboratory to test

b. In the laboratory's procedure titled "SOP

c. Between February 2015 and September 21,

2. Based on review of the quality control (QC) 2/12/16

c. CL SOP-09161, Revision A (Apolipoprotein)

d. CL SOP-10001, Revision 8 (Measuring

e. CL SOP-06060, Revision A (SensoScientific

f;ll 1 AND PLAN OF CORRECTION IDENTIFICATION NUMBER: A. BUILDING

0502025714 B.WING 11/20/2015

05403 Conti.nued From page 11 05403

c. CL SOP-09161, Revision A (Apolipoprotein) All active SOPs relevant to testing

e. CL SOP-06060, Revision A (SensoScientific

g. CL PLN-14003, Revision A (Master Validation

h. Three of three procedures for the Advia

e. Review of 3 manufacturer instructions for

f. The Director of Assay Systems and technical

2. Based on review of the procedure,

b. The generJI supervisor stated that the

c. The package insert for lot number 539280

d. Review of the Pl revealed an "important note"

e. The current vial of lnnovin reagent was

f. CL SOP-10001 Revision A, "Measuring

g. The general supervisor confirmed on 9/23/15

a. The general supervisor and techincal

b. They further stated that the laboratory staff

c. The Director of Assays confirmed that the

05421 Continued From page 16 05421

~~il!1; AND PLAN OF CORRECTION IDENTIFICATION NUMBER:

0502025714 B. WING 11/20/2015

05421 Continued From page 17 05421

ii. The manufacturer performed the verification

iii. The accuracy study included samples which

iv. The accuracy study did not include samples

v. The accuracy study did not include a

vi. The accuracy study did not indicate an

vii. The precision study included samples which

0502025714 B.WING 11/20/2015

05421 Continued From page 18

viii. The precision study did not include samples

ix. The precision study only included within run

x. The summary report from the manufacturer

xi. The reportable range data showed included

i. Standard Operating Procedure (SOP) CL

ii. The manufacturer performed the verification

iii. The accuracy study included samples which

iv. The accuracy study did not include samples