Friday, February 03, 2006

Manslaughter case against UK lab worker collapses

Updated 9 Nov. 2013
As a follow-up to my earlier blog (Manslaughter charged following wrong blood fatality in UK):

The case against the biomedical scientist on trial in the UK for manslaughter has collapsed. The crown decided that, while negligence could have been proved for a civil case, the crime of manslaughter (gross negligence), was not provable in the case:
Negligence Primer

Disclaimer: I am not a lawyer. The following information has been compiled from an Internet search and is presented solely for the interest of readers. Readers are advised to consult the resources in Further Reading, which are provided as aids to identify more information on this complex topic.
By way of review, 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 civil case, the plaintiff, or person suing, must generally satisfy the court of the following four elements:
  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). Patients also have the right to expect a reasonable standard of care from healthcare students who treat them.

  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 breach must be the proximate cause of the harm (the causal link between the defendant's act and the injury or loss). The most common test is the "but for" test. That is, if the accident 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.
In the case of the UK biomedical scientist , all 4 elements needed for a civil negligence case would seem to have been met. However, criminal negligence resulting in a charge of manslaughter require additional criteria.

Criminal Negligence
To meet the standard for criminal negligence, the act or omission must show a wanton or reckless disregard for the lives or safety of other persons. For example, a nurse in the USA was found guilty of criminal negligence (reckless manslaughter) for hiding an empty bag of blood after it was transfused to the wrong person. Transfusing the wrong blood by failing to perform required pretransfusion identity checks may show negligence but what made the nurse's act criminal - reckless manslaughter - was the failure to disclose the error upon its discovery.
For discussion of negligence in the context of student health professionals, see TraQ's Case A8:
Further Reading

  1. Berry DB. The physician's guide to medical malpractice. Proc (Bayl Univ Med Cent). 2001 Jan; 14(1): 109–12. (Free full text)

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Thursday, February 02, 2006

Manslaughter charged following wrong blood fatality in UK

Updated 9 Nov. 2013
There have been only a few court cases involving medical laboratory technologists/scientists but there is currently one happening in the UK:
Biomedical scientist on trial in the UK for gross negligence manslaughter

The case involves a group O patient who was mistyped as AB, received group A red cells, and died from multi-organ failure, presumably secondary to a severe hemolytic transfuion reaction caused by multiple errors. Not only was the patient mistyped, but she was apparently crossmatched with outdated gel cards. An in-house protocol to have a second person verify the results at the blood grouping stage was not followed. And a second person was also mistyped as group AB, fortunately not requiring transfusion.

The defendant has admitted his mistakes, claimed "mental aberration", and argued that there were contributing deficiencies at the hospital which had nothing to do with him, such as staff shortages, and that the transfusion had been unnecessary.

Anyone who has performed ABO blood typing knows that mistyping a group O person as group AB means that the grouping was read "bassackwards". In a way it's like reading the number 2006 as 6002. Regardless, it's a relatively common error made by newbee students but an incredible error for an experienced technologist to make.

Breaking in-house protocols designed to increase safety, such as requiring a second person to verify ABO blood grouping, is unacceptable but does happen, particularly under the stress of urgent calls for blood. In this case ignoring the protocol appears to be a systemic error, since the lab was cited for it during an earlier audit.

Using outdated reagents such as the gel cards used for antibody screening and crossmatching is another major error. The newspaper report of the court case suggests that the laboratory may have been trying to save money by using outdated cards that it had in excess quantity due to poor inventory management. Even if quality control of the outdated reagents was acceptable, using outdated reagents for something as critical as antibody detection and compatibility testing breaks regulatory blood safety standards.

My experience with using outdated reagents in the student lab shows that most reagents work well past their expiry date. And many transfusion services use outdated reagents under special circumstances, e.g., use rare reagent antisera for antigen phenotyping; use outdated rare red cells as positive controls for antigen phenotyping.

It would be interesting to investigate if outdated gel cards function acceptably past their shelf life and for how, even if they cannot be used for patient testing, since this may indicate another technical error by the accused in this case. Regardless of any suspending media and reagents, the crossmatch gel cards would have contained patient group O plasma and donor group A red cells.

In summary, from a regulatory perspective, this case involves multiple errors:

  • technical (human) error in misinterpreting the ABO blood group
  • failure to follow SOPs (no second person verified the ABO blood)
  • failure to use in-date reagents (gel cards)
  • possible technical (human) error in not detecting the ABO incompatible donor units in the crossmatch.
Some of the errors seem system-wide but others seem specific to the individual's actions. All of which serves to illustrate that you cannot entirely prevent human error. But much progress can be made and efforts continue. See, for example:
More details of manslaughter case:
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