This section will discuss transfusion-related responsibilities and the players involved, including the scope of TS and medical director responsibility for off-site laboratories and transfusion-related patient care. The discussion is not meant to be definitive.
- This case
- Self study questions
- Further Reading
Special thanks to the following hematopathologists, who provided advice on the scope of medical director and transfusion service responsibility.
- Gwen Clarke, MD FRCPC (Capital Health, University of Alberta, & Canadian Blood Services, Edmonton, AB)
- Susan Nahirniak, MD, FRCPC, Medical Director, Capital Health Transfusion Services (Edmonton)
The roles of the blood supplier (in Canada, Canadian Blood Services and Héma-Québec) will NOT be discussed. In general, the blood supplier is responsible for providing a safe and affordable supply of blood, blood products, and alternatives. For example, see CBS responsibilities.
Discussing the in-depth responsibilities of all the professionals involved in transfusion is beyond the scope of this case study. The discussion that follows is meant to reinforce the breadth of the responsibilities of the TS medical director, while acknowledging the important roles of other health professionals.
Responsibility for transfusion safety is shared by all health professionals involved in the blood system from blood collection to transfusion. Donors too are responsible for the safety of the blood supply, in that they are expected to respond honestly to all pre-donation screening questions and follow-up with the blood centre if appropriate.
Besides staff who work for the suppliers of blood and blood products, the main health professionals involved and their responsibilities can be briefly described as follows.
NOTE: This list does not cover many of the responsibilities specified in blood safety standards. The list provides examples only and was adapted (some wording and content has been changed and updated) from a Canadian Red Cross publication (Clinical Guide to Transfusion 1), currently being revised by CBS.
Physicians who order blood and blood products, whose major responsibilities include but are not limited to these roles:
exercise informed judgment about clinical needs for transfusion
explain the risks and benefits of transfusion to each patient (informed consent is required by blood safety standards)
give clear directions about the products to be transfused, the quantity and rate of administration
indicate the degree of urgency and provide adequate clinical information to the hospital transfusion service
notify the transfusion service when crossmatched blood is no longer required, and cooperate in establishing priorities for using blood when shortages occur
report all significant, unexpected transfusion reactions (blood safety standard requirement) and assist in investigating the causes
Physicians and medical laboratory technologists in hospital transfusion services, whose major responsibilities include but are not limited to these roles (excludes specific medical director responsibilities, which are more fully covered below): (all are encompassed by blood safety standard requirements)
offer advice about the appropriate use of blood and blood products within the hospital
maintain adequate inventories of blood and blood products, store inventories under safe conditions, and control their issue
establish and maintain an active quality system
establish and maintain training policies and procedures and competency assessment programs
establish and maintain written policies and procedures to ensure that the requirements of blood safety standards are met
keep adequate records of the receipt, storage condition, and disposition of all blood products, and of all patient testing for periods specified in relevant standards
establish a transfusion committee that regularly reviews the appropriateness of the use of blood and blood products and reviews blood transfusion practices in the hospital
investigate all significant transfusion reactions and report results to the blood supplier
Physicians, nurses, and phlebotomists in hospital units where blood and blood products are transfused, whose major responsibilities include but are not limited to these roles: (all are encompassed by blood safety standard requirements)
provide appropriate and properly identified blood specimens to the transfusion service for compatibility testing
ensure patient and donor unit identity prior to transfusion
verify that blood to be transfused has been found compatible or has been selected to be compatible with the patient's blood group
infuse the blood or blood product promptly after receipt from the transfusion service using suitable administration sets and solutions, and following the clinical instructions of the attending physician
record all transfusions in the patient's medical record
monitor patients before, during, and after transfusion
recognize the signs and symptoms of transfusion reactions and transfusion-associated adverse events
report adverse reactions to the attending physician and the hospital transfusion service, record the reactions in the patient's chart, and assist with investigations
As mentioned in Medical Consultation, quality and safety is everyone's responsibility but every TS must have a medical director who is ultimately responsible for all medical and technical policies and procedures in the TS. Put another way, the buck stops here!
More specifically, in Canada (CSTM A.3.1.5; CSA 220.127.116.11, A3.1.6 ), the medical director is responsible for
all TS activities that affect the TS, personnel, and test results
all TS policies that relate to the care and safety of blood recipients
the TS quality system and quality assurance
If the required technical and medical expertise is not available within the facility, the TS shall arrange for consultative services with a qualified individual. (CSTM A.3.1.5; CSA 18.104.22.168)
Responsibility extends not only to the central facility but also to all subsidiaries (e.g., satellite sites) of the TS that perform activities governed by the standards (CSTM A1.2; CSA 4.1.2)
Some transfusion-related responsibilities are shared by the players involved. For example, transfusion committees with documented terms of reference, composed of stakeholders (e.g., TM medical director, medical staff, especially from the services that are heavy transfusion users, anesthetists, nurses), who meet regularly (in Canada at least quarterly), play a key role.
Responsibilities include defining transfusion policies, ensuring that transfusion practices are regularly evaluated, developing criteria for assessing ordering practices and blood usage, disseminating information and education, evaluating adverse events, and reviewing alternatives to allogeneic transfusion.
In Canada and elsewhere, while many facilities have transfusion committees, anecdotal evidence suggests that their activity levels vary widely and that achieving active participation by busy professionals is difficult. Where there is a central TS responsible for several satellite sites, transfusion committees are not required for each facility but rather for each region.
Broadly speaking, the technical staff of the central TM laboratory, under the direction of the medical director,are responsible for ensuring that transfusion products are the best possible and have undergone appropriate pretransfusion testing for compatibility with the patient.
If there is any uncertainty about the efficacy, quality, or safety of a blood product, the laboratory must ensure that the attending physician has the opportunity to discuss risks and alternatives with a qualified consultant. The laboratory's role in this instance is to provide appropriate liaison.
These share joint responsibility with the blood supplier and central testing laboratoryfor ensuring that appropriate blood products are available in a timely fashion. Delays or difficulties in carrying out these responsibilities should result in medical consultation and appropriate follow-up with the attending physician.
Ultimately, the attending physician has responsibility for treating the patient, including transfusion needs. Prescribing of blood transfusions should be based on national guidelines for the clinical use of blood, taking individual patient needs into account, and considering risks and benefits. Individual clinicians are responsible for ensuring that theirdecisions are appropriate for their patients and that patients receive appropriate care post-transfusion.
Like countries such as the UK and Australia, Canada has a national blood service (Canadian Blood Services) to manage the blood supply (except in Quebec, where Héma-Québec has this role). On the transfusion end, Canada has multiple regional TS, usually within hospitals.
Other countries have integrated vein-to-vein national blood systems that encompass both managing the blood supply and providing transfusion medicine services (e.g., NZ). Yet others have a mixed system, most notably the USA with hospital blood banks, community blood centers, and American Red Cross regional blood centers collecting, processing, storing, and distributing blood; and multiple TS within hospitals or central testing facilities sometimes associated with blood centers.
In Canada, TS are mostly managed by provincial health regions. Within this framework it is common for a single central TM laboratory to be responsible for several satellite laboratories, and sometimes to serve as a reference laboratory for one or more small rural facilities, including dispensary-only laboratories. In some locales, a private or public laboratory is contracted to provide pathology and TM consultation, including technical and nursing support, to small hospitals.
In the case of a central TS with satellite laboratories, typically the central testing laboratory develops policies, processes, and procedures for all sites, with input from those involved at the satellite site. Providing such support to small remote facilities requires major investments of time and resources.
Because national blood safety standards requiring a quality system (QS) are relatively new for Canadian TS, the development of region-wide SOPs, document control, and other QS requirements is best described as a work in progress. Many regions have developed regional SOPs; see, for example, Sharing our Strategies (SOS) Manual 2. However, implementing regional audits of small facilities is not widespread yet due to resource constraints.
In some locales small hospitals, particularly those with dispensary-only laboratories, may have fallen through the cracks and operate with inadequate and unclear lines of support.
A complete analysis of legal responsibility is beyond the scope of this case (or my expertise - I am not a lawyer!), however, a brief review of key legal concepts may be informative:
Negligence is often defined as
(1) not doing something which a reasonable person would do, or
(2) doing something which a reasonable person would not do.
Thus negligence can involve acts of commission and acts of omission. In order to succeed in a negligence case, the plaintiff, or person suing, must generally satisfy the court of the following four elements:
- Duty of care
- Breach of standard of care
- Injury or loss
- Causation - breach must be the proximate cause of the harm (the causal link between the defendant's act and the injury or loss)
1. Duty of care. A person who practices in a health profession owes the patient a duty. The duty of care involves applying skill, knowledge, diligence and caution when caring for patients.
2. Breach of standard of care. The standard of care is primarily determined by the general practice of the profession. The practitioner does not need to live up to the highest standards but rather the reasonable, accepted standards set for the profession. Standards of care are determined by consulting experts,and relevant practice guidelines and standards (such as blood safety standards).
3. Injury or loss. For negligence to occur, the patient must have experienced injury or loss of some kind due to the negligent act.
4. Causation. The most common test is the "but for" test. That is, if the incident would not have occurred but for the defendant's negligence, then the conduct is the cause of the injury. There must be a clear direct connection between the negligent act and the harm caused to the patient.
Note also that ignorance of accepted standard practices or required safety standards is not a valid defense for negligence if the health professional should have known the practice or standard in question. Malpractice suits can occur if a professional performs duties improperly out of ignorance, carelessness, or intentional misconduct.
Another relevant concept to consider is that of an affirmative defense. An affirmative defense admits that all four elements of a medical malpractice action exist, but the defendant argues that the existence of other factors excuses the health professional's actions.3
Relevant factors include:
- The medical director from the central TS visited the dispensing facility twice a year and seldom spent more than 1?2 hours with the laboratory manager.
- The laboratory managertypically operated with minimal or no consultation, believing this was expected in the position.
- The central testing laboratory did not develop system-wide policies and procedures for its small satellite laboratories.
- Generalist staff, including the laboratory manager,were ignorant of several important TM practices and blood safety standards.
- critical values or alert values/situations that required medical consultation
- the prohibition of issuing group-specific RBC based on records alone
- how many units of blood to issue at once to wards without temperature-controlled refrigerators
- criteria for entering issued blood back into inventory and reissuing it
Regarding legal liability for negligence, all 4 elements appear to have been met for negligence to have occurred.
- Each TS must have a medical director, who is ultimately responsible for all medical and technical policies and procedures, including in satellite facilities.
- Many health professionals share responsibility for blood transfusion in a chain that extends vein-to-vein, from donor to patient.
- Providing adequate TM support to small satellite facilities, as mandated by blood safety standards, is challenging.
- Ignorance is not a defense for negligence.
- The requirements of blood safety standards are costly and may serve to decrease the number of facilities involved in transfusion. Many smaller hospitals transfuse and store very little blood, and the services of some may need to be centralized in order to meet standards.
- When visiting dispensaries and other small sites, the medical director or designate, as well as technical and nursing liaison staff, should consider using the occasion to perform mini-accreditation inspections in order to identify key procedural and policy gaps that require update and improvement. For example, one visit could be used to audit patient identification processes, another to audit informed consent processes, etc.
TraQ self study questions
1. Name 6 types of healthcare workers who participate in transfusion.
2. Who is ultimately responsible for all medical and technical policies and procedures in the TS?
3. Who is responsible for ensuring that required technical and medical expertise is available within a TS satellite facility?
4. In this case, if the family had decided to sue, assuming that the 4 elements needed to succeed in a negligence case were met, speculate on one or more possible affirmative defenses.
- Part 1: Use of historical blood groups
- Part 2. Issuing blood to the OR
- Part 3. Medical consultation
- Part 4: Transfusion-related responsibilities <--You are here
- Part 5: Training and competency assessment
2. Hamilton QUEST. Sharing our Strategies (SOS) Manual
3. WeblocatorTM for finding attorneys and legal research.Florida Personal Injury Defense Law: Medical & Professional Malpractice
Australian Red Cross Blood Service. General principles of the transfusion practice (Ch. 4). In: Transfusion medicine manual. ARCBS.