Posted by Sten Westgard, MS
With sincere thanks to Carolyn Maurer, the Director of the CAP 15189 program.
I admit that I thought the IQCP impact would be contained within the US, that contagion would not spread to the international community. After all, IQCP is only a required option for labs within the US, and then only required for labs that seek to find a replacement to their now-outdated EQC policies. For labs that don't want to reduce their QC frequency below once a day, there's no need to create an IQCP at all.
But the situation appears to be more complicated. CAP, which has a significant international presence, is rolling out IQCP to all of its members, not just its US customers.
In light of that, I asked CAP how it balances the IQCP reduced QC frequency with the ISO 15189 standards. Their answers, after the jump...
Question: If a laboratory has a test where they run quality control (QC) only once every 31 days, does that make them ineligible for ISO 15189 accreditation?
Answer: Particular to the College of American Pathologists (CAP), medical laboratories accredited by the CAP Laboratory Accreditation Program (LAP) are eligible for application to CAP 15189. Laboratories would need to meet LAP Checklist requirements.
Question: I know that CAP has a type of ISO 15189 accreditation - are Individualized Quality Control Plans (IQCPs) allowed in that program or not?
Answer: The CAP issues accreditation to ISO 15189:2012. Medical laboratories that achieve accreditation to ISO 15189 must meet the requirements of the ISO 15189:2012 International Standard.
Compliance to CLIA requirements and LAP standards including regulatory requirements on IQCP would default to meeting the LAP Checklists. Enclosed are the IQCP FAQ’s from the CAP website.
CAP 15189 Program assessors may ask to see examples of documented risk assessments relating to clause 4.14.6 for core processes that directly affect patient care and the lab may show IQCP as an example. A nonconformity may present if the laboratory is not adhering to the laboratory’s QMS policies, process procedures. (See Page 7 in the attached Risk Management Guide).[editor's note: I will post this in the westgard.com download section]
Question: Do you know if there are any official statements from the ISO standards committees to affirm or deny that reduced QC frequency is considered acceptable for ISO 15189 accredited labs?
Answer: The CAP is not aware of any official statements from the ISO technical committees that reduced QC frequency is considered acceptable for laboratories accredited to ISO 15189 accredited laboratories. The Secretariat and Convener of TC 212 WG1 can be reached through the ISO link http://www.iso.org/iso/iso_technical_committee?commid=54916
Here's a question to you, the international reader: does this clarify the issue for you? Does it help you decide whether or not you will develop an IQCP as part of your CAP accreditation?
Do you believe the ISO 15189 standard is compatible with once a month QC frequency?