Posted by Sten Westgard, MS
- Do all labs need to purchase the EP23 guideline, booklet, and worksheet?
The CMS memo contains a curious Acknowledgement:
"In light of advancements in technology, CMS has adopted a risk based approach termed Individualized Quality Control Plan (IQCP). the Clinical and Laboratory Standards Institute (CLSI) document EP23-A - "Laboratory Quality Control Based on Risk Management: Approved Guideline" provides helpful guidance to laboratories on the development of quality control plans for test systems. Portions of the EP23-A document capture the principles of our intended policies. So, as EP23-A is a copyrighted work of CLSI, we obtained CLSI's permission to utilize those portions of the CLSI EP23-A Guideline that captured our intended policies for IQCP under the equivalent quality testing provisioins of the CLIA program."
One might read this and conclude that all the relevant EP23 material will be found directly in the regulations and State Operators Manual, thus it isn't necessary to purchase the EP23 guideline at all. Or perhaps CMS is just cribbing a few of the EP23 notes, and labs should still buy the CLSI documents.
- Do you need to use any Risk Management tools to comply with EP23 and IQCP?
Again, a very curious Q&A included in the memo:
"Will laboratories be required to use a process map, fishbone diagrams, formal risk assessment charts and protocols, etc. in their IQCP?
No, CLIA will not require the use of these tools in the development of an IQCP."
This is strange indeed. CMS is rolling out a risk based approach for QC, but will not be requiring labs to use formal risk tools or protocols? What do you call Risk Assessment if it doesn't include the use of Risk Assessment protocols? Is EP23 a formal risk assessment protocol? If so, is that also unnecessary in the development of an IQCP (see question 1)
The credibility of this new risk based QC approach is built on the good reputation and success that these risk assessment tools and protocols have achieved outside healthcare. The very reason Risk Management was considered a viable approach was the existence, indeed the wealth, of tools and protocols that were available. To adopt a risk approach without any of the tools and protocols is, frankly, a little bizarre .
- Will Deemed Accreditation Organizations have to implement IQCPs?
From the Question and Answer section of the Memo:
"Will accrediting organizations (AO) and exempt states (ES) be required to accept the use of the IQCP option?
It will be optional for AOs and ESs to incorporate IQCP into their standards; however, any standards they use will need toeither be a regulatory equivalent tothe current CLIA regulations, or an acceptable equivalent tothe IQCP option as laid out in Attachment 1-IQCP."
In other words, all organizations will be forced by CMS to accept IQCPs. An AO has the option to say Yes, or it can lose its deemed status. This is what we saw with EQC. AOs initially resisted, but eventually caved and implemented a version of EQC.
- Will inspectors be able to assess and even challenge the Risk QC of a laboratory?
Again, from the Question and Answer section of the Memo:
"What if the surveyor doesn't agree with the way the LD has addressed the risks in the QCP?
The surveyors will be trained to determine if a risk assessment was performed, if the identified risks were evaluated, if the QCP includes any risk(s) that the laboratory director has determined needs to be mitigated, and that quality assessment is occurring and ongoing."
The short answer we're looking for: An inspector is empowered to assess and challenge the laboratory's IQCP. The answer here seems a bit muddled and unclear. If an inspector is not allowed to point out failure modes that the laboratory director may have missed in the risk assessment, or is not allowed challenge the evaluation of those risks (i.e. the laboratory director thinks the risk is acceptable or has been mitigated, but the inspector disagrees), then the IQCP may become a toothless regulation. If inspectors cannot challenge IQCP implementation, then any IQCP implementation will be in compliance (and laboratory directors will not be strongly motivated to identify risks or determine any risks need mitigation).
- Will labs need to develop "re-testing" plans?
The language of the regulations on "Quality Assessment" contains some intriguing requirements about what is necessary if a QCP fails:
"All IQCP Quality Assessment monitoring must be part of the laboratory’s overall Quality Assessment plan. The laboratory must establish a review system for the ongoing monitoring of the effectiveness of their IQCP.... "When the laboratory discovers a testing process failure, the laboratory must conduct an investigation to identify the cause of the failure, its impact on patient care, and make appropriate modifications to their QCP, as applicable. The investigation must include documentation of all corrections, corresponding corrective actions for all patients affected by the testing process failure, and evaluation of the effectiveness of the corrective action(s). The laboratory must implement the correction(s) and corresponding corrective action(s) necessary to resolve the failure and reduce the risk of recurrence of the failure in the future. If necessary, the laboratory must update the risk assessment with the new information and modify the QCP, as needed.
"Has the laboratory established a review system for the ongoing monitoring of the QCP...and evaluation of its effectiveness?....
"In the event of a testing process failure, has the laboratory evaluated all patient test results since the last acceptable quality control?"
Perhaps I'm reading too much into these paragraphs, but this seems like a higher bar than what was required for EQC. The laboratory needs to have a real system in place to monitor and if necessary retest the specimens, should the QCP reveal an out-of-control signal. By default, that might limit the frequency to the capacity of the lab to store specimens.
There are more questions one could raise, and we hope will be raised, as the new IQCP regulations are rolled out. EQC failed because it wasn't introduced properly to the laboratory community. EQC also failed because it was created without a proper scientific foundation. Let's hope the IQCP regulations have identified, addressed, and mitigated those risks.