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Case Study A8 Discussion Part 5 - Regulations and Standards
 

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Home Case Studies A-Level Case A8: Severe Hemolytic Transfusion Reaction Involving a Student Case Study A8 Discussion Part 5 - Regulations and Standards
Monday, 23 July 2018

Case Study A8 Discussion Part 5 - Regulations and Standards

This case involves a transfusion-related death that was disclosed to the patient's family and involved a student error.

REPORTING OF SERIOUS ADVERSE EVENTS

In many countriestransfusion services participate in voluntary hemovigilance (surveillance) systems such as:

Countries many also have voluntary blood safety standards, which represent current best practice, that require the reporting of serious adverse events via a step-wise process from the patient's physician to the transfusion service, who then reports to the blood supplier (or government), who then reports to the government.

Many countries have mandatory regulations for reporting serious adverse events, often currently limited to blood suppliers and not hospital transfusion services.

CANADA

In Canada both CSTM Standards and CSA Standard Z902-15 specify that serious adverse events must be reported immediately to the transfusion service. Serious adverse events include (but are not limited to):

  • immediate hemolytic reactions

  • delayed hemolysis

  • transfusion-related acute lung injury

  • systemic allergic reactions, including anaphylactic shock

  • bacterial sepsis

  • other transfusion-transmissible infections

  • transfusion-associated graft versus host disease

  • post-transfusion purpura

  • deaths

  • Any adverse reactions that can be attributed to the quality of the blood and blood products must be reported to the blood supplier.

  • All fatalities related to blood transfusion shall be reported to the bloodsupplier for reporting to Health Canada.

USA

In the USA, several agencies provide regulatory and quality oversight of transfusion medicine.

AABB www.aabb.org The Joint Commission, formerly JCAHO The Joint Commission
FDA www.fda.gov CAP www.cap.org
CBER www.fda.gov/cber FACT www.factwebsite.org

Reporting requirements for adverse events are similar to those in Canada, for example, voluntary AABB Standards require that

  • serious reactions be reported to the patient's physician and the transfusion service

  • any adverse reactions that can be attributed to blood and blood products must be reported to the blood supplier

FDA current good manufacturing practices (cGMP) regulations for blood and blood components require reporting of fatalities related to blood collection or transfusion to the FDA.

FDA - CBER: 21 CFR 606.170(b) states:

    When a complication of blood collection or transfusion is confirmed to be fatal, the Director, Office of Compliance and Biologics Quality, Center for Biologics Evaluation and Research, shall be notified by telephone, facsimile, express mail, or electronically transmitted mail as soon as possible; a written report of the investigation shall be submitted to the Director, Office of Compliance and Biologics Quality, Center for Biologics Evaluation and Research, within 7 days after the fatality by the collecting facility in the event of a donor reaction, or by the facility that performed the compatibility tests in the event of a transfusion reaction.

Also see OTHERS

Europe

Europe has an extensive International Haemovigilance Network, including the UK SHOT Program.

Individual countries have regulations and standards, as well as the EU blood Directive.

DISCLOSURE OF UNANTICIPATED PATIENT OUTCOMES

Blood safety standards and regulations do not cover disclosure of unexpected outcomes to patients, and instead focus on reporting of serious adverse events to applicable departments, organizations, and government bodies.

As discussed under risk management, disclosure of medical errors remains controversial but is increasingly promoted based on ethics, patient rights, and quality systems.

In Canada, disclosure of error is not addressed officially (at the time this case was written). However, legal cases suggest that doctors who make an error in treating patients have a positive legal duty to inform the patient.3

In the USA The Joint Commission instituted a new standard on disclosure in 2001. Standard RI.1.2.2 states:

  • "Patients, and when appropriate, their families are informed about the outcomes of care, including unanticipated outcomes."
  • RI.1.2.2 further states that the "responsible licensed independent practitioner or his or her designee clearly explains the outcome of any treatments or procedures to the patient and, when appropriate, the family, whenever those outcomes differ significantly from the anticipated outcomes."

JCAHO does not state specifically what should be disclosed to patients or their families; the scoring guideline merely indicates that hospitals will be scored on whether the patient and/or the family were informed when appropriate4.

PROVISION OF PATIENT CARE BY STUDENT PRACTITIONERS

Blood safety standards and regulations include personnel requirements but do not address provision of healthcare by students.

However, as discussed in Supervision of Students, patients have the right to expect a reasonable standard of care from the students who treat them, and the courts have held students to the same standard as practicing professionals. Moreover, supervisors have a duty to patients to provide adequate levels of supervision to ensure that standards are met.

Standard of care is generally determined by guidelines and standards, as well as the opinions of experts. For example, if a blood standard required that immediately before transfusion, and in the presence of the recipient, the transfusionist must confirm and document that all identifying information linking the recipient and the blood product match1 (CSTM L2.2), the standard applies to all transfusions, whether the transfusionist is a practicing nurse or a student nurse being supervised. The supervising nurse is responsible for ensuring that the student is aware of the standard and that the standard is followed.

Even when standards and guidelines exist, expert opinion carries much weight. Because patient care is complex and every situation is different, experts are required to interpret what actions were "reasonable" and conform to accepted practices at the time, given the circumstances.

THIS CASE

In Case A8, the transfusion service followed regulations and standards applicable at the time.

  • The adverse event (patient death following severe hemolytic transfusion reaction) was reported to the medical examiner and to the blood supplier.
  • Although not required by law to do so, full disclosure was made to the patient's family.

Because the family did not file a law suit, there was no opportunity to investigate whether the conduct of those involved breached a reasonable standard of care.

TRAQ SELF STUDY QUESTIONS

  1. As related to blood safety standards, what two responsibilities do practitioners who supervise students have?

    Answer

Proceed to Case Summary

Last modified on Tuesday, 18 October 2016 13:44