Risk management is discussed briefly below.
- Background issues
- Risk management in the hospital setting
- Disclosure of adverse events to patients
- This case
- TraQ self study questions
- More discussion
Risk management can be defined in many ways but is basically a planned and formal system to improve the quality and safe delivery of healthcare by:
- Identifying circumstances that put patients at risk of harm (e.g., near misses, adverse events)
- Acting to prevent or control those risks.
Financial loss vs quality
The rise of risk management in healthcare can be viewed as having two antecedents:
- Need to prevent financial losses from malpractice claims
- Emphasis on a quality system approach that includes identifying and reporting medical errors in order to maintain high quality and improve the system
See Canada's situation in the 1980s - Keddy WR, Johnson MW, McKerrow W. Hospital risk management: the second decade. Health Manage Forum 1988 Spring;1(1):12-7.
Discipline vs quality
The emphasis on quality systems and its blame-free approach to error management creates challenges related to employee discipline. See
Marx discusses the pros and cons of three approaches to discipline for employees who make errors:
- Outcome-based: Discipline only if outcome is bad (adverse event happens)
- Rule-based: Discipline if rule (standard, guideline) is broken, only if intentional; or discipline if rule is broken, even if unintentional
- Risk-based: Discipline depending on intent, e.g., discipline if person is reckless towards the safety of others and takes an unjustifiable risk; for other situations such as inadvertent human error and negligence, see the Marx paper.
Today the administration of hospitals and most other health organizations have a risk management division. Often it is administered by the hospital's legal affairs department and works closely with staff from quality assurance, patient rights and advocacy, and many clinical departments. See
Kuhn AM, Youngberg BJ. The need for risk management to evolve to assure a culture of safety. Qual Saf Health Care 2002;11:158-62.
Risk management is a complex process beyond the scope of this case. However, it includes developing explicit guidelines for when health providers must contact the risk management office and for how to disclose medical error to patients and their families.
Historically, disclosure of medical errors has been controversial because disclosure, if it implies an admission of liability, makes healthcare professionals vulnerable to law suits.
Today full disclosure remains controversial but is increasingly promoted.
- From a quality perspective, disclosure makes sense as part of a plan to promote blame-free error management and enhance patient safety.
- From an ethical perspective, disclosure makes sense since not disclosing errors to patients undermines the public trust in medicine because it suggests deception in order to preserve professional interests over the well-being of patients. Not disclosing can also be seen as a breach of professional ethics, specifically a lapse in the commitment to act solely in the patient's best interest. In contrast, disclosure fits with today's approach to patients - more respect for patient rights and increased participation by patients in their care and treatment.
See these discussions on error disclosure:
- Hébert PC, Levin AV, Robertson G. Bioethics for clinicians: 23. Disclosure of medical error. CMAJ 2001 Feb 20; 164 (4).
- Liang BA. A system of medical error disclosure. Qual Saf Health Care 2002;11:64-8
- Mazor KM, Simon SR, Gurwitz JH. Communicating With patients about medical errors: A review of the literature (abstract). Arch Int Med 2004 Aug 9; 164(15): 1690 -7.
How to Disclose
When medical error leads to an adverse event, healthcare providers are counselled to be careful how they disclose errors. For example, some organizations advise against giving an apology as it can be seen as an admission of fault. Timing is also critical, since disclosure should not occur until all the facts are known.
Studies* have shown that patients prefer physicians to:
- Explicitly state than an error occurred
- Describe what the error was and its clinical implications
- Explain why the error happened
- Discuss how error recurrences will be prevented
- Apologize for the error
For a comprehensive discussion of disclosure, see
- *Washington University. Teaching module. Talking about harmful medical errors with patients.
The hospital's Risk Management Office was contacted and the chief counsel discussed the case with the TS medical director and Patient B's physician.
A series of group meetings were held with the TS laboratory supervisor, student, supervising technologist, and TS clinical instructor all being present. Besides discussing everything that happened and possible legal ramifications, legal counsel instructed everyone involved not to discuss the case outside the presence of the legal counsel and stated that the family had 2 years to file a law suit.
In Case A8, the student who made the pipetting error initially believed that she had added patient plasma to the correct tubes and never did explicitly admit making an error. However, because the evidence of the gel card with an abnormal volume was incontrovertible, the student ultimately tacitly accepted that she "must have made an error" even though she believed she had not. This acceptance was facilitated by focusing on system flaws as opposed to laying blame.
The supervising medical technologist had acted within the framework of training in the department, i.e., gradually allowing the student to perform with less supervision but always reading test results. The technologist acknowledged that the abnormal volume in the gel card should have been detected when she read them and was extremely distraught over the hemolytic transfusion reaction that resulted from missing it.
TS laboratory ("the system")
The transfusion service laboratory (leadership and staff) reviewed its processes for training and supervising students and new staff, its process for performing batch testing; the timing of follow-up investigations, and related risk management issues.
Supervisory policies were analyzed for the risks involved in gradually providing less supervision of students, balanced with what was possible.
- Existing supervisory policies were maintained.
- In-service training sessions were held for staff to share and improve supervising strategies when also working on the bench.
Batch testing procedures were analyzed. For students in training the maximum number of patients per batch was 5. The laboratory decided to give more emphasis to ensuring that patient plasma was added to the correct antibody screen tests as follows:
- In-service training sessions were held for staff related to teaching staff and students technical tips for organizing work such as batch testing, e.g., simple but effective strategies such as aligning gel cards in the same row as the corresponding patient specimen; picking them both up to confirm identity; and moving the card laterally to indicate that it is the one to which patient plasma will be added.
Timing of follow-up investigations was analyzed. If the antibody panel had been done the same day instead of the next morning, the error would have been discovered in time to prevent the incompatible transfusion from happening.
- The SOP for positive antibody screen tests was modified to explicitly state that, in the absense of exceptional circumstances, repeat antibody screen testing and/or antibody identification was to be done expeditiously on the same or next shift, regardless of the patient's transfusion requirements. The revised policy would be monitored for impact on staffing.
Medical Examiner's Office
The Chief Medical Examiner was notified a nd the investigation concluded that the patient's condition was such that he would have died even if the incompatible RBC were not transfused but that the transfusions and resulting HTR likely contributed to death happening faster.
Despite the hospital lacking a policy of error disclosure, the medical director of the transfusion service, in consultation with the patient's physician and risk management office, and in the presence of a member of the facility's patient support team, disclosed and explained what had happened to the patient's family, summarized as follows:
- An error occurred involving the patient's treatment
- The error was that pretransfusion testing in the transfusion service laboratory missed an antibody that the patient had, resulting in him being transfused with incompatible blood. An investigation by the medical examiner's office determined that the patient's condition was terminal even without transfusion. However, the incompatible blood caused a transfusion reaction that hastened the patient's death.
- The error in testing involved inadvertently not adding patient sample to a pretransfusion test and the oversight went undetected until after the patient had been transfused. Even though the transfusion service does all it can to prevent errors and enhance patient safety, the system is not foolproof and human errors unfortunately still occur, albeit rarely.
- The transfusion service will review all policies and processes associated with the event and will do whatever is necessary to improve the system and prevent any recurrence.
- The medical director on behalf of everyone involved in the transfusion service apologized to the patient's family by expressing how sorry they were that this event had occurred. The family was encouraged to ask questions about what happened.
The patient's family conveyed to the medical director that they appreciated her honesty in explaining what had happened and the efforts to prevent it from happening again. After two years (the statute of limitations on law suits for personal injuries in the hospital's location), the family had not filed a law suit.
The student who made the pipetting error believed that she had added patient plasma to the correct tubes and never did explicitly admit making an error. The supervising technologist admitted that she should have noticed the abnormal test volume but did not.
- Is this a typical first reaction when people make errors?
- Which approach to error management facilitates staff actively detecting errors and admitting to them.
- What is the challenge of a blame- free environment?
- What is the main risk involved in full disclosure to patients or their families with an apology
- Part 1: Root cause analysis
- Part 2: Testing errors
- Part 3: Risk management <--You are here
- Part 4: Supervision of students
- Part 5: Regulations and standards