|Year : 2017 | Volume
| Issue : 1 | Page : 5-7
Legal issues in transfusion medicine
Department of Pathology and Transfusion Medicine, SDMH Hospital, Jaipur, India
|Date of Web Publication||22-Mar-2017|
Department of Pathology and Transfusion Medicine, SDMH Hospital, Jaipur
Source of Support: None, Conflict of Interest: None
|How to cite this article:|
Gupta G. Legal issues in transfusion medicine. Glob J Transfus Med 2017;2:5-7
| Is There a Need for Regulation of Blood Transfusion Services?|| |
The spine-chilling memories of the Arkansas Prison Blood Scandal in the US  and the Tainted Blood Scandal in the UK  of the 1980s wherein thousands of hemophilia patients worldwide were infected with human immunodeficiency virus (HIV) and hepatitis C as a result of transfusion with Factor VIII are grim indicators of the medicolegal intricacies in transfusion medicine. Also unfortunate are the farmers of the so-called AIDS villages of plasmapheresis donors in China who were victims of unregulated commercial blood/plasma collection between 1992 and 1995 in Central China which caused the second major epidemic of HIV type 1 infection in China. In recent times, the Creutzfeldt-Jakob disease- and cytomegalovirus-contaminated blood products recalled by the Canadian Red Cross (1990s and 2013) demonstrate the minefield of hazards in this lifesaving intervention.
| Memorable Lawsuits Leading to Revamping of the Blood Transfusion Services|| |
Legal and regulatory guidelines notwithstanding, lawsuits are increasingly becoming common, more so in transfusion medicine, as the hazards of transfusion make it an unavoidable but unsafe product. The whole gamut of the activities including blood donation, processing, storage, and transport with administration and follow-up of blood or its components is fraught with chances of error and inadvertent harm. The harm may be wrong blood to a wrong patient, like in the case of the pregnant burns' patient who lost her baby and developed kidney failure  or in cases of unnecessary transfusions of platelet transfusions  in cases of dengue in direct contravention of national guidelines. Fortunately, not all adverse events result in death or significant morbidity. There are tens of thousands of noninfectious adverse effects of transfusion annually in India, but because of nonstreamlined monitoring they are often not reported. The best statistics of hazards of transfusion are of serious hazards of transfusion (SHOT) wherein a recent SHOT analysis showed 1125 errors (2015) in a total of 3288 transfusion-related adverse events with one in three preventable errors and nearly one-third of preventable deaths. These are just the tip of the iceberg as the majority of adverse events worldwide remain underreported and therefore not improved upon.
| Growth of Transfusion Services|| |
Transfusion services are safer today than any time in history with better donor screening, increased voluntary donors, advanced transfusion-transmissible infection (TTI) screening, automation in transfusion medicine, and improved quality assurance systems being put in place. However, in the international scenario, only 125 countries have national guidelines on blood safety with around 67% of hospitals (in high-income countries) appointing transfusion committees and only 54% performing clinical audits. A mere 28% of low-income countries have a national hemovigilance system, and the incidence of TTI in donated blood is 1.08% for HIV, 3.7% for hepatitis B virus (HBV), and 1.03% for hepatitis C virus (in middle-income countries). In addition, 25 countries are not able to screen for one or more of the mandatory testing advisory by the WHO, with only 34% of laboratories following external quality assessment scheme in low-income countries.
The first blood bank in India was started in Calcutta in 1945, but licensing had started only in 1975 with testing for HBV, syphilis, and malaria. Till the mid-90s, up to 8% of new HIV infections in India were attributed to the transmission of unsafe blood which led to mandatory HIV testing in 1988. In 1990, a report on the blood banking system in India was prepared by M/S A F Ferguson and Co., which brought out several deficiencies in respect of nonuniformity in the licensing of blood banks which led to (i) the responsibility for ensuring blood safety was shifted to the National Drug Control Authority; (ii) a ban was to be imposed on “professional” blood donations by 1997; and (iii) all blood banks were to be licensed in the next 2 years or face closure. Human blood is categorized as a “drug” under Section 3(b) of the Drugs and Cosmetics Act, 1940. Since initial formulation, the ambit of the Drugs and Cosmetics Act, 1940 has been expanded, and the rules have accordingly been frequently amended to incorporate ongoing and current concerns. The National AIDS Control Project, 1992–1999 funded by the World Bank, Government of India, and co-financed by the World Health Organization, had 30% of its project cost focusing on blood safety. The National Blood Policy in 2002 closely followed the inclusion of hepatitis C testing in blood; other improvements included the standardization of blood storage centers, National Plasma Policy, and recently the baseline assessment of all blood banks in India in 2016.
Despite all regulations errors do occur. Legal liability requires duty of care with breach of the duty of care and damage consequently on the breach. The duty of care relates to the foreseeability of harm which in the case of blood is not totally predictable. The law does not envisage the medical professionals working with the sword of Damocles hanging on their heads, so legal liability is acceptable only in cases of negligently causing harm by deviating from the accepted medical standard of care the legal issues raised generally fall in four categories.
Liability due to deficiency in care, consent, counseling, and communication
A donor who received injuries due to a fall after donating plasma sued the plasma donation facility accusing them of lack of care and failure to implement and follow protocol  Another donor sued the hospital for serious nerve injury in his arm postphlebotomy. Another lawsuit pertains to faulty hemoglobin estimation leading to anemic patients donating blood  and sharing of blood donor information without consent. A donor fatality occurrence resulted in legal liability for counseling deficiency and deficiency in emergency care by the blood bank team.
Informed consent has a very important effect on liability in voluntary blood donors and transfusion recipients. Preventable errors are avoided by proper patient communication, education at all times, all duly documented. The donor should understand the risks to others of donating infected blood and his or her ethical responsibility to the recipient. Blood donation and transfusion of blood or its components must be based on regularly reviewed medical guidelines and criteria.
Liability due to the administration of infected blood components or products
In 2010, the Food and Drug Administration (FDA) fined the American Red Cross for lapses including failing to notify health departments when donated blood was found to be infected with HIV, hepatitis C, or the West Nile virus, failing to promptly alert health-care facilities when expired or infected blood had been distributed, failing to register adverse donor reactions as a result of giving blood, and incorrect labeling of blood products. In addition, the FDA cited the Red Cross for poor quality assurance, including keeping blood products out of controlled storage for more than 30 min, a backlog of approximately 18,000 donor management cases and insufficient record-keeping.
There are approximately 108 million blood donations in a year worldwide. There are risks inherent in using material derived from human sources with undetectable elements leading to the possibility of harm. The testing in many countries is not reliable due to irregularly supplied kits, staff shortages, poor-quality test kits, and lack of quality assurance measures. Nondisclosure of illness by donor, inadequate predonation counseling, window period of infections, limited mandated testing on donated blood, limitations of diagnostic tests used, ineffective control mechanisms in transport and storage, and many more deficiencies are the hiccups in safe blood transmission. The impossibility of eliminating all risk is the rationale behind optimum use of blood.
Human blood transfusion being akin to an organ transplant is beset by unpredictable tricky mechanisms of harm to recipient at any point of time.
Liability due to mismatched blood
In 1999, the Joint Commission identified mismatched transfusion as a sentinel event and suggested strategies for reducing transfusion risk. Data from the UK SHOT initiative show that around 1 in 13,000 blood units are administered to the wrong patient with occasional fatal outcomes. Incidents include the Virginia patient who died of a mismatched transfusion when she switched beds with her roommate for a window view  or the navy veteran whose sampling error led to a wrong plasma transfusion. These are just the tip of the iceberg. The root cause of most incidents is misidentification at the time of pretransfusion blood sampling, laboratory testing, collecting the blood component from the blood bank, or administration of the transfusion at the bedside.
Liability due to improper administration of blood products
A Hazleton hospital was found to have violations in care of patient in a case of mismatched blood transfusion fatality. The liability included failure to provide a safe setting for the patient receiving blood by failing to ensure established policy, failure to ensure nursing assessment, failure to meet staffing requirements, failure to inform administrator on call, bedside failure for positive identification of the blood, and recipient at bedside and failure to obtain vital signs 15 min after transfusion. Physicians can be held vicariously liable for negligent transfusions if improperly supervised or delegated. The hospital is also vicariously liable for the acts of its employees. The transfusion medicine department is liable for errors in collection, processing, storage, and issue of blood or component. Proper administration of blood includes right patient, right dose, right product, right time, right site, with right indication along with right communication, education, and documentation.
| Conclusion|| |
In a nutshell, blood is an invaluable resource with inherent risks. Professional negligence involves a foreseeable risk of injury and in transfusion medicine it is not entirely applicable. Risk mitigation efforts include written policies and procedures, use of standard documentation, and scrupulous record-keeping which will minimize the gravity of the medico-legal consequences if any. Risk management strategies include improved vein-to-vein tracking efficiency with bar-coded blood bags, remote release refrigerators interfaced with transfusion software, bedside validating, and patient identification technologies. Despite all these advances, human error is possible for which constant training, competency evaluation, double check systems, nonpunitive nonconformance reporting, and management with continual quality improvement initiatives are some of the ways for transfusion safety.
| References|| |
Qian HZ, Vermund SH, Kaslow RA, Coffey CS, Chamot E, Yang Z, et al.
Co-infection with HIV and hepatitis C virus in former plasma/blood donors: Challenge for patient care in rural China. AIDS 2006;20:1429-35.
Llewelyn CA, Hewitt PE, Knight RS, Amar K, Cousens S, Mackenzie J, et al.
Possible transmission of variant Creutzfeldt-Jakob disease by blood transfusion. Lancet 2004;363:417-21.
Bhattacharya P, Marwaha N, Dhawan HK, Roy P, Sharma RR. Transfusion-related adverse events at the tertiary care center in North India: An institutional hemovigilance effort. Asian J Transfus Sci 2011;5:164-70.
] [Full text]
Ahamed SI, Bharath RR. Role of platelet transfusion and its misuse in managing dengue fever. Int J Sci Study 2015;3:110-3.
National Guidebook on Blood Donor Motivation. 2nd
ed. India: Government of India, National AIDS Control Organization, Ministry of Health and Family Welfare; 2003. p. 32-5.
Dubin CH. Technology, vigilance, and blood transfusions: How U.S. Hospitals and the federal government are working to reduce adverse events. P