PC194

Answer B or D. Shipped on February 10, 2020 FINAL RESULTS

HISTORY

The challenge was sent to category A, C, and C1 laboratories. The following scenario was presented to participants:

Your laboratory hires a new Quality Team member responsible for your section. In preparing to understand the laboratory operations and actions, the Quality Team member implements an informal internal audit, which includes checking on the activities in relation to requirements within the international standard, ISO15189:2012 (medical laboratories – requirements for quality and competence). This will allow the Quality Team to prepare for your next full accreditation audit expected in 6 months. After the review, the new staff person reports back about the requirement:

“The laboratory, in consultation with the users, shall establish turnaround times for each of its examinations that reflect clinical needs. The laboratory shall periodically evaluate whether or not it is meeting the established turnaround times (4.14.7 Quality Indicators: Note 2).”

You are informed they cannot find any information in any of the laboratory’s manuals that this has been done. You go through your records and you too find no information this has been looked at for at least 10 years.
The participants were directed to select the best option:
A. Do nothing. If it was important, the accreditation body would have already found it and required us to do something.
B. Contact your accreditation body to get clarification of their position on this requirement.
C. Ask the new Quality Team member to check what other laboratories have done, and then ask to use their information.
D. Ask the new Quality Team member to set up a task team to develop a “trial” set of turnaround times to be rolled out before the next
accreditation site visit.
E. Ask the new Quality Team member to set up a task team to urgently develop a new set of turnaround times to be implemented before the
next accreditation site visit.

MAIN EDUCATIONAL POINTS from PC194

  1. The best approach to findings of non-conforming practices is to:
    (a) document the deficiency as an Opportunity for Improvement,
    (b) investigate why the deficiency may have occurred,
    (c) implement a plan to amend the deficiency and,
    (d) monitor any measures implemented to correct the deficiency.

Full critique (PDF)

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