Republic Act 7719 - National Blood Services Act of 1994 Republic of the Philippines Congress of the Philippines Metro

Manila Second Regular Session Begun and held in Metro Manila. on Monday the twenty-sixth day of July nineteen hundred and ninety three. REPUBLlC ACT No.7719 AN ACT PROMOTING VOLUNTARY BLOOD DONATION, PROVIDING FOR AN ADEQUATE SUPPLY OF SAFE BLOOD. REGULATING BLOOD BANKS. AND PROVIDING PENAL TIES FOR VIOLATION THEREOF Be it enacted by the Senate and House of Representatives of the Philippines in Congress assembled: SECTION 1. Title. - This Act shall be known as the "National Blood Services Act of 1994". SECTION 2. Declaration of Policy. - In order to promote public health, it is hereby declared the policy of the Stae: a) to promote and encourage voluntary blood donation by the citizenry and to instill ublic consciousness of the principle that blood donation is a humanitarian act; b) to lay down the legal principle that the provision of blood for transfusion is a professional medical service and not a sale of a commodity; c) to provide for adequate, safe, affordable and equitable distribution of supply of blood and blood products; d) to inform the public of the need for voluntary blood donation the hazards caused by the ocmmercial sale of blood; e) to teach the benefits and rationale of voluntary blood donation existing health subjects of the formal education system in all public /private schools, in the elementary, high school and college levels as the nonformal education system; f) to mobilize all sectors of the community to participate in mechanisms for voluntary and non-profit collection of blood; g) to mandate the Department of Health to establish and organize a National Blood Transfusion Service Network in order to rationalize and improve the provision of adequate and safe supply of blood; h) to provide for adequate assistance to institutions promoting non-profit blood services, either through a system of reimbursement for costs from patients who can afford to pay, or donations from governmental and non-governmental entities; i) to require all blood collection units and blood banks/centers to operate on a non-profit basis; j) to establish scientific and professional standards for the operation of blood collection units and blood banks/centers in the Philippines;" k) to regulate and ensure the safety of all activities related to the collection, storage and banking of blood; and l) to require upgrading of blood banks/centers to include preventive services and education to control spread of blood transfusion transmissible diseases. Sec. 3. Definitions. For purposes of this Act, the following terms shall mean: a) Blood/blood product refers to human blood, processed or unprocessed and includes blood components, its products and derivatives;

b) Blood bank/center a laboratory or institution with the capability to recruit and screen blood donors, collect, process, store, transport and issue blood for transfusion and provide information and/or education on blood transfusion transmissible diseases; c) Commercial blood bank a blood bank that exists for profit; d) Hospital-based blood bank a blood bank which is located within the premises of a hospital and which can perform compatibility testing of blood; e) Blood collection unit an institution or facility duly authorized by the Department of Health to recruit and screen donor and collect blood; f) Voluntary blood donor one who donates blood on one's own volition or initiative and without monetary compensation; g) Department the Department of the Health; h) Blood transfusion transmissible diseases diseases which may be transmitted as a result of blood transfusion, including AID, Hepatitis-B, Malaria and Syphilis; i) Secretary of Health the Secretary of Health or any other person to whom the Secretary delegates the responsibility of carrying out the provisions of this Act; and j) Walking Blood Donor an individual included in the list of qualified voluntary blood donors referred to in Section 4, paragraph (e), who is ready to donate blood when needed in his/her community. Sec. 4. Promotion of Voluntary Blood Donation. In order to ensure adequate supply of human blood, voluntary blood donation shall be promoted through the following: a) Public Education. Through an organized and sustained nationwide public education campaign by the Department, the Philippine National Red Cross (PNRC) and the Philippine Blood Coordinating Council (PBCC), as the lead agencies, other government agencies, local government units (particularly the barangays), nongovernmental organizations, all medical organizations, all public and private hospitals, all health and healthrelated institutions, print and broadcast media as well as other sectors. The Department is hereby authorized to set aside funds and generated financial support for all sectors involved in the collection and processing of blood from voluntary blood donors through a system of reimbursement for costs for patients who can afford to pay or from donations from government and private institutions. Voluntary donors shall likewise be provided non-monetary incentives as may be determined by the Department. b) Promotion in Schools. The benefits rationale of voluntary blood donation shall be included and given emphasis in health subjects of schools, both public and private, at the elementary, high school and college levels. The Department of Education, Culture and Sports shall also require such inclusion in its non-formal education curricula. c) Professional Education. The Department, the PBCC, the Philippine Society of Hematology and Blood Transfusion (PSHBT), the Philippine Society of Pathologists (PSP), the Philippine Medical Association (PMA), the Philippine Associations of Medical Technologists (PAMET) and the Philippine Nursing Association (PNA) are encouraged to conduct for their respective members and as part of the continuing medical education, trainings on the rational use of blood and blood products including the merits of voluntary blood donation. d) Establishment of Blood Services Network. Blood centers shall be strategically established in every province and city nationwide within the framework of a National Blood Transfusion Service Network spearheaded by the Department, in coordinating with the PNRC. The collection of blood in various areas in the community, such as schools, business enterprises, barangays, and military camps shall be promoted. The Secretary shall set the standards for the scientific and professional establishment and operation of blood banks/centers and collection units. The Department shall provide training programs and technical assistance to enable communities, schools, industrial and business sites, barangays, military camps and local government units to implement their own voluntary blood donation programs. e) Walking Blood Donors In areas where there may be inadequate blood banking facilities, the walking blood donor concept shall be encouraged and all government hospitals, rural-health units, health centers, and barangays in these areas shall be required to keep at all times a list of qualified voluntary blood donors with their specified blood typing.

Sec. 5. National Voluntary Blood Services Program. The Department, in cooperation with the PNRC and PBCC and other government agencies and non-governmental organizations shall plan and implement a National Voluntary Blood Services Program (NVBSP) to meet in an evolutionary manner, the needs for blood transfusion in all regions of the country. Funds for this purpose shall be provided by the Government through the budgetary allocation of the Department by the Philippine Charity Sweepstakes Office (PCSO) with an initial amount of at least Twenty-five million pesos (P25,000,000), by the Philippine Amusement and Gaming Corporation (PAGCOR) with an initial amount of at least Twenty-five million pesos (P25,000,000), by the trust liability account of the Duty Free Shop (Duty Free Philippines) with an initial amount of at least Twenty million pesos (P20,000,000) and through contributions of other agencies such as civic organizations. Sec. 6. Upgrading of Services and Facilities. All blood banks/centers shall provide preventive health services such as education and counseling on blood transfusion transmissible diseases. All government hospitals, including those that have been devolved, shall be required to establish voluntary blood donation programs and all private hospitals shall be encouraged to establish voluntary blood donation programs. The Department, in consultation with the PSHBT and the PSP, shall also establish guidelines for the rational use of blood and blood products. Sec. 7. Phase-out of Commercial Blood Banks. All commercial blood banks shall be phased-out over a period of two (2) years after the effectivity of this Act, extendable to a maximum period of two (2) years by the Secretary. Sec. 8. Non-Profit Operation. All blood banks/centers shall operate on a non-profit basis: Provided, That they may collect service fees not greater than the maximum prescribed by the Department which shall be limited to the necessary expenses entailed in collecting and processing of blood. Blood shall be collected from healthy voluntary donors only. Sec. 9. Regulation of Blood Services. It shall be unlawful for any person to establish and operate a blood bank/center unless it is registered and issued a license to operate by the Department: Provided, That in case of emergencies, blood collection and transfusion under the responsibility of the attending physician shall be allowed in hospitals without such license under certain conditions prescribed by the Department. No license shall be granted or renewed by the Department for the establishment and operation of a blood bank/center unless it complies with the standards prescribed by the Department. Such blood bank/center shall be under the management of a licensed and qualified physician duly authorized by the Department. Sec. 10. Importation of Blood Bank Equipment, Blood Bags and Reagents. Upon the effectivity of this Act, equipment, blood bags and reagents used for the screening and testing of donors, collection and processing and storage of blood shall be imported tax and duty-free by the PNRC, blood banks and hospitals participating actively in the National Voluntary Blood Services Program. This provision shall be implemented by the rules and regulations to be promulgated by the Department in consultation and coordination with the Department of Finance. Sec. 11. Rules and Regulations. The implementation of the provisions of this Act shall be in accordance with the rules and regulations to be promulgated by the Secretary, within sixty (60) days from the approval hereof. The existing Revised Rules and Regulations Governing the Collection, Processing and Provision of Human Blood and the Establishment and Operation of Blood Banks shall remain in force unless amended or revised by the Secretary. The rules and regulations shall prescribe from time to time the maximum ceiling for fees for the provision of blood, including its collection, processing and storage, professional services and a reasonable allowance for spoilage. Sec. 12. Penalties. Upon complaint of any person and after due notice and hearing, any blood bank/center which shall collect charges and fees greater than the maximum prescribed by the Department shall have its license suspended or revoked by the Secretary. Any person or persons who shall be responsible for the above violation shall suffer the penalty of imprisonment of not less than one (1) month nor more than six (6) months, or a fine of not less than Five thousand pesos (P5,000) nor more than Fifty thousand pesos (P50,000), or both at the discretion of the competent court. Any person who shall establish and operate a blood bank without securing any license to operate from the Department or who fails to comply with the standards prescribed by the Department referred to in Section 9 hereof shall suffer the penalty of imprisonment of not less than twelve (12) years and one (1) day nor more

than twenty (20) years or a fine of not less than Fifty thousand pesos (P50,000) nor more than Five hundred thousand pesos (P500,000), or both at the discretion of the competent court. The Secretary after due notice and hearing, may impose administrative sanctions such as but not limited to fines, suspension, or revocation of license to operate a blood bank/center and to recommend the suspension or revocation of the license to practice the profession when applicable. The head of the blood bank and the necessary trained personnel under the head's direct supervision found responsible for dispensing, transfusing and failing to dispose, within forty-eight (48) hours, blood which have been proven contaminated with blood transfusion transmissible diseases shall be imprisoned for ten (10) years. This is without prejudice to the filing of criminal charges under the Revised Penal Code. Sec. 13. Separability Clause. If any provision of this Act is declared invalid, the other provisions hereof not affected thereby shall remain in force and effect. Sec. 14. Repealing Clause. This Act shall supersede Republic Act No. 1517 entitled "Blood Bank Act." The provisions of any law, executive order, presidential decree or other issuances inconsistent with this Act are hereby repealed or modified accordingly. Sec. 15. Effectivity Clause. This Act shall take effect after fifteen (15) days following its publication in the Official Gazette or in two (2) national newspapers of general circulation. Approved, May 5, 1994

10 Facts About Blood Transfusions Every Physician, Nurse, & Hospital Executive Should Know
1. Transfusions are inherently hazardous
The blood collection industry has done a remarkable job of reducing the risk of viral transmission through donor screening and blood testing. While it is true that blood products are the safest in history, transfusions are not risk free and cause some degree of harm in every patient due to the physical properties of stored blood and because of impairments in immune system function. The leading causes of transfusion-related morbidity and mortality are unrelated to viral transmission and include bacterial contamination of platelets (1:2000- 3000 transfusions), transfusion errors from patient misidentification (1:16,000- 19,000), transfusion related acute lung injury (TRALI) (1:1000- 5000) and transfusion associated circulatory overload (TACO) (1:350). Analogous to chemotherapy, blood transfusions can improve outcomes but only when used in the right patient for the right indication and in the right dose.

(1) Boucher BA, Hannon TJ. Blood management: a primer for clinicians. Pharmacotherapy 2007;27:1394-411. (2) Goodnough LT. Risks of blood transfusion. [Review] [124 refs]. Critical Care Medicine 2003;31:S678-S686. (3) Toy P, Popovsky MA, Abraham E et al. Transfusion-related acute lung injury: definition and review. Crit Care Med 2005;33:721-6. (4) Dzik WH. Emily Cooley Lecture 2002: transfusion safety in the hospital. Transfusion 2003;43:1190-9.

2. Blood is a liquid transplant

Blood transfusions are essentially organ transplants so they logically cause changes in the immune system function of patients who receive them. Because each transfusion represents a new donor and a new set of immune challenges, each transfusion causes a stepwise increase in serious complications including postoperative infection rates, ventilator-acquired pneumonia, central line sepsis, ICU and hospital length of stay, as well as short term and long term mortality rates.

(1) Boucher BA, Hannon TJ. Blood management: a primer for clinicians. Pharmacotherapy 2007;27:1394-411. (2) Shorr AF, Duh MS, Kelly KM et al. Red blood cell transfusion and ventilator-associated pneumonia: A potential link? Crit Care Med 2004;32:666-74. (3) Taylor RW, Manganaro L, OBrien J et al. Impact of allogenic packed red blood cell transfusion on nosocomial infection rates in the critically ill patient. Crit Care Med 2002;30:2249-54. (4) Shorr AF, Jackson WL. Transfusion practice and nosocomial infection: assessing the evidence. Curr Opin Crit Care 2005;11:468-72.

3. Transfusions are double trouble for hospital acquired infections

By some estimates each unit of allogeneic blood increases nosocomial infection rates by 50%, so transfusing a patient with two units of blood will double the rate of hospital acquired infections. Therefore the common practice to automatically order two units of red blood cells at a time makes no sense from a resource consumption or patient safety standpoint.

(1) Shorr AF, Duh MS, Kelly KM et al. Red blood cell transfusion and ventilatorassociated pneumonia: A potential link? Crit Care Med 2004;32:666-74. (2) Taylor RW, Manganaro L, OBrien J et al. Impact of allogenic packed red blood cell transfusion on nosocomial infection rates in the critically ill patient. Crit Care Med 2002;30:2249-54. (3) Shorr AF, Jackson WL. Transfusion practice and nosocomial infection: assessing the evidence. Curr Opin Crit Care 2005;11:468-72.

4. Less is more for transfusions

Based upon the current risks of blood transfusions and controlled studies of transfusion efficacy (risk: benefit ratio), the best available evidence for transfusion therapy indicates that a more conservative approach to blood transfusions not only saves blood but improves patient outcomes and saves lives (less is more).

(1) Hebert PC, Wells G, Blajchman MA et al. A multicenter, randomized, controlled clinical trial of transfusion requirements in critical care. Transfusion Requirements in Critical Care Investigators, Canadian Critical Care Trials Group. N Engl J Med 1999;340:409-17. (2) Corwin HL. Anemia and red blood cell transfusion in the critically ill. Semin Dial 2006;19:513-6. (3) Napolitano LM, Kurek S, Luchette FA, et al. Clinical practice guideline: Red blood cell transfusion in adult trauma and critical care. Crit Care Med 2009; 37:3124-57.

5. Transfusion education is a bloody mess

Most physicians who order blood products lack formal training in transfusion therapy, and many are unaware of current transfusion guidelines. Similarly, most nursing schools fall short in terms of training in transfusion safety and blood administration competency. Because of these gaps in knowledge, the ordering and administration of blood products is shrouded by emotions, misconceptions, myths, and prescribing by habit. Compounding these issues is the fact that blood utilization oversight is lacking at most hospitals as witnessed by studies that document wide variations in transfusion practice between institutions and among physicians at the same institution.

(1) Dzik WH. Emily Cooley Lecture 2002: transfusion safety in the hospital. Transfusion 2003;43:1190-9. (2) Stover EP, Siegel LC, Parks R et al. Variability in transfusion practice for coronary artery bypass surgery persists despite national consensus guidelines: a 24-institution study. Institutions of the Multicenter Study of Perioperative Ischemia Research Group. Anesthesiology 1998;88:327-33. (3) Corwin HL, Gettinger A, Pearl RG et al. The CRIT Study: Anemia and blood transfusion in the critically ill--current clinical practice in the United States. Crit Care Med 2004;32:39-52.

6. America is a blood thirsty nation

Blood utilization in the United States is significantly higher than in most Western countries and the gap is increasing. While blood utilization in the U.S. increased by 16% from 1999- 2004, it decreased by 8% in the United Kingdom during the same period. Remarkably, blood utilization in the U.S. is currently 15% higher per capita than in Europe and 44% higher than in Canada. This difference is likely attributable to a combination of national transfusion education programs, hemovigilance programs which spotlight transfusion risks, and accountability for performance and compliance at the hospital level.

(1) Wallis JP, Wells AW, Chapman CE. Changing indications for red cell transfusion from 2000 to 2004 in the North of England. Transfus Med 2006;16:411-7. (2) Yazer M, Triulzi D. Messages from national blood data collection reports. Transfusion 2007;47:366-8. (3) MacPherson J, Mahoney CB, Katz L et al. Contribution of blood to hospital revenue in the United States. Transfusion 2007;47:114S-6S.

7. Blood shortages and blood costs have hospitals seeing red

Blood utilization in the U.S. has risen steadily at a rate of 2- 3% a year because of an aging population, increasingly complex surgeries and aggressive chemotherapy regimens. At the same time, the number of eligible donors has been declining because of a growing number of donor deferral criteria which are instituted to protect the blood supply. A recent study estimated that 66 million fewer people are eligible to donate blood than previously thought, leaving only about 37 percent of the U.S. population as potential donors. This supply and demand mismatch means that blood banks now have to work harder to recruit donors and blood shortages will become more frequent, leading to interruptions in hospital operations and cancellation of elective surgeries. The end result of donor recruitment challenges and the increasing costs of testing and processing blood has been a doubling of blood prices in the past few years, and prices are expected to increase by 6- 10% per year going forward.

(1) Riley W, Schwei M, McCullough J. The United States potential blood donor pool: estimating the prevalence of donor-exclusion factors on the pool of potential donors. Transfusion 2007;47(7):1180-88. (2) Hannon TJ, Paulson-Gjerde K. Contemporary economics of transfusions. In: Spiess BD, Spence RK, Shander A, eds. Perioperative Transfusion Medicine. Philadelphia: Lippincott Williams & Wilkins, 2005.

8. Blood costs are the tip of the iceberg for the total cost of transfusions
The total cost of transfusing patients exceeds blood acquisition costs by five times or greater when labor, supplies, blood administration and transfusion-related adverse events costs are considered. The cost to purchase blood products, while significant for many hospitals, is only the tip of the iceberg for total blood costs.

Hannon TJ, Paulson-Gjerde K. Contemporary economics of transfusions. In: Spiess BD, Spence RK, Shander A, eds. Perioperative Transfusion Medicine. Philadelphia: Lippincott Williams & Wilkins, 2005.

9. Transfusions are risky business

There are a number of emerging areas of risk exposure and potential medical-legal liability that relate to compliance with state, federal (CMS), Joint Commission, AABB and CAP regulations for blood component therapy. These include patient safety issues (the Joint Commission National Patient Safety Goal #1 is to eliminate medication and transfusion errors), appropriateness and documentation of physician transfusion orders, nursing compliance and documentation, oversight systems and effectiveness of peer review, and informed consent for transfusion. From a compliance and medical-legal standpoint, the financial liability of inappropriate transfusions and transfusion errors can be substantial. Because of these many issues, the Joint Commission is currently testing Blood Management Performance measures as an element of hospital accreditation.

(1) Boucher BA, Hannon TJ. Blood management: a primer for clinicians. Pharmacotherapy 2007;27:1394-411. (2)

http://www.jointcommission.org/PerformanceMeasurement/PerformanceMeasurement/Blood+Management++Utilization.htm

10. Transfusion complications: You break it, you pay for it

Topping it all off, financial penalties for adverse clinical outcomes related to inappropriate transfusion practices are increasing. Since October 2008, Medicare and most commercial health insurance carriers will no longer pay for transfusion errors, bleeding complications in cardiac surgery and a growing number of hospital acquired infections that are increased two to five-fold by blood transfusions. Beneath are ten risks associated with blood transfusions that each patient should be aware of: 1.) Viruses and infectious ailments Even even though blood donation organizations and blood banks have strict screening and testing procedures, there have been situations exactly where individuals have received contaminated blood from a transfusion. Viruses and ailments that can be transmitted by way of a blood transfusion incorporate HIV, Hepatitis, West Nile Virus, and CJD (the human type of mad cow illness). two.) Allergic reaction When blood is donated, it is donated as complete blood. The complete blood is then separated into the numerous blood parts that might be needed in a transfusion (red and white cells, platelets, and so on.). Occasionally the donor blood can contain other particles which may trigger an allergic reaction in the recipient. Allergic reactions during a transfusion can be mild to serious and call for the transfusion to be stopped at the initial sign.

three.) Lung injury In some situations, patients receiving a blood transfusion can encounter lung harm. This can be caused by an immune reaction which attacks the recipients lungs. Lung injuries present a significant blood transfusion danger almost 25% of these injuries prove fatal. 4.) Graft-versus-host illness (GVHD) Graft-versus-host disease (GVHD) is a severe condition where the new white blood cells attack the recipients body. This condition generally only affects patients with weak immune systems and is usually fatal. five.) Acute immune hemolytic reaction An acute immune hemolytic reaction is a uncommon, but serious condition. This occurs when the recipients body attacks the new red blood cells. This creates substances in the blood that can harm the kidneys. The transfusion should be stopped quickly at the first sign of an acute immune hemolytic reaction. The symptoms incorporate dark urine, fever, chills, and back or chest discomfort. 6.) Delayed hemolytic reaction A delayed immune hemolytic reaction is similar to the acute condition even so, the delayed reaction is significantly slower. This type of reaction is extremely dangerous since it can go unnoticed although the patients red blood count drops. 7.) Fever When an additional persons blood enters the recipients body, a fever is a regular and widespread immune response to the presence of the foreign white blood cells. Most fevers are mild and do not disrupt the transfusion. 8.) Too significantly iron In some cases, exactly where a patient need to acquire large amounts of blood by way of many transfusions, too significantly iron can create up in the blood. An iron overload such as this can damage the liver and other important organs. 9.) Fluid overload Individuals who ought to obtain several transfusions are at risk for fluid overload. Basically the presence of too significantly fluid in the blood, fluid overload can result in a reduction in the quantity of oxygen in the blood. Cardiac failure can result if the excess fluid isnt promptly drained. 10.) Human error / incorrect blood kind -

Blood transfusions are a medical operation and, as with any medical procedure, there is often the danger for human error. If a patient accidentally receives the incorrect blood kind for the duration of a transfusion, they could suffer mild to serious allergic reactions and other severe complications.

About the Author: Norman A. Smyke Jr, MD, is a board certified specialist in Anesthesiology and is the medical director of the Center for Blood Conservation at Grant. Dr. Smyke received his MD from the Ohio State University College of Medicine in 1989. He has been an active physician at OhioHealths Grant Medical Center since 1996 and is a member of the Society for the Advancement of Blood Management. In addition to getting the medical director for the Center for Blood Conservation at Grant, Dr. Smyke is also the director for resident and student nurse anesthetist education and is the director of the airway management plan at Grant.

Dr. Smyke oversees the first bloodless medicine plan in Columbus, Ohio and outlying places to offer formally recognized blood management services, including bloodless surgery. Blood conservation in the course of surgery and the field of bloodless medicine are possibilities accessible to patients wishing to prevent having a blood transfusion.

The Center for Blood Conservation at Grant is a multidisciplinary system that contains far more than 75 skilled physicians and covers a wide range of specialties. Robust expertise in hematology is needed for a profitable bloodless medicine program. Dr. Shakir Sarwar, hematologist/oncologist, actively contributes to the Center for Blood Conservation.

For a lot more data about the Center for Blood Conservation at Grant, please check outwww.ohiohealth.com.

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