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Standards Update: Codifying the obvious

by Dennis Ernst • September 05, 2018

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_400wIt's hard to imagine a venipuncture standard not requiring some of the aspects of the procedure we all know to be necessary. Such was the case when the CLSI committee tasked with the revision got to work. For example, prior versions of the standard did not mention:

  • Using a needle only once---this means once the needle has been removed from the patient, it cannot be reinserted in the case of a missed vein or any other reason.
  • using a safety transfer device when transferring blood from a syringe into a tube---OSHA established this as a practice in 2002. Tube stoppers cannot be pierced and the tube filled with the same needle that performed the puncture when using a syringe.
  • assembling devices in the presence of the patient---Patients need to see the device assembled in their presence in order to have the confidence the needle is not left over from the last patient. Devices preassembled by the manufacturer and shipped in sterile packaging are acceptable, but the sterile package must be opened in the presence of the patient.
  • gloves must remain intact throughout the procedure---this codifies the ban on tearing the tip of the glove's finger off in order to palpate the vein.
  • tubes must be filled to their stated volume---This has always been a best practice. Now it's against the standards to underfill a tube.
  • the contents of tubes cannot be combined---Also a best practice, and now banned by the standards.

Codifying all these common-sense concepts is long overdue in a global standard. This, and every other revision mentioned in this series makes the new CLSI venipuncture standard (GP41-A7) the most comprehensive, rigorous, and perfected version in the document's history, which goes back to 1977.

Editor's note: This completes this series on revisions to the CLSI venipuncture standard. Readers are urged to obtain their own copy of the standard as soon as possible and begin implementing all new provisions immediately. 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. It can be obtained from CLSI or the Center for Phlebotomy Education, Inc.


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