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Standards Update: Non-conforming events

by Dennis Ernst • November 03, 2017

The newly revised venipuncture standard released by the Clinical and Laboratory Standards Institute in April, 2017 is the most comprehensive revision in the document's history. With over 140 new mandates, facilities have a lot of changes to implement. This series discusses one or more substantive changes each month.

GP41_cover_400wHow are policy or procedure violations handled where you work? If you are a manager, what is your protocol? Do you have one that's well established, or are corrective measures randomly applied?

According to the newly revised CLSI standard, a nonconforming event (NCE) management program must be in place in every facility. Deviations from approved phlebotomy procedures must be investigated, documented, and classified, and remedial action taken. All deviations are significant and require implementation of the plan, but especially for: 

  • errors in establishing patient identification
  • using an improper protocol when labeling samples
  • failure to follow the established procedure when collecting, transporting, handling and/or processing samples
  • customer service incidents
  • safety violations
  • confidentiality breaches

Implementing a NCE management program isn't only required when a patient is actually misidentified, a sample mislabeled, or confidential patient information leaked. It's prudent even when a procedural deviation doesn't result in an error. For example, if a phlebotomist labels a tube before it is filled when the facility's policy restricts labeling until after it is filled, it's an NCE even if correct label is applied because the procedure was performed improperly. If a computer screen projecting a patient's sensitive data is left unattended and potentially accessible to those who had no need for the information being projected, it's an NCE even if nobody saw the screen. 

By implementing a facility's NCE management plan for such near-misses, the facility is taking proactive measures to prevent catastrophic consequences. It's the difference between being proactive and being reactive, between preventing an injury or breach and managing the damages from one.

To comply with the standard, an NCE management program must identify all problem-prone processes, improve the process to prevent the error, implement process and procedure changes, and acquire administrative support to eliminate the cause of the NCE.


Editor's note: Readers are urged to obtain their own copy of the standard as soon as possible and begin implementing all new provisions as soon as possible. The document, Collection of Diagnostic Venous Blood Specimens (GP41-A7), is the standard to which all facilities will be held if a patient is injured during the procedure or suffers from the consequences of an improperly performed venipuncture.

Read an interview by CLP Magazine with Dennis J. Ernst MT(ASCP), NCPT(NCCT) about the revised standard.


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