We knew that the accreditation agencies needed to develop their own policies to handle the new CMS IQCP regulations. CAP gets the prize for being first out of the gate with some practical steps, as well retaining some safeguards for quality.
IQCP, if it's not already burned into your head, stands for Individualized Quality Control Plan, and this is supposed to be the replacement for the EQC policies which have been in place for several years. The EQC policies are being replaced, you may recall, because they are scientifically untenable. It was hoped that IQCP was going to be more scientifically robust. That remains to be seen. CAP is attempting to assure that it will implement the CMS IQCP regulations but also provide a higher level of quality assurance than that low bar.
More after the jump.
CAP issued three new documents:
- IQCP Frequently Asked Questions
- Proposed CAP Checklist Requirements for IQCP
- Eligibility Determination for IQCP Option
We have also dropped them into our own download section. This is just so we can retain a central location where all documents IQCP can be stored. And if CAP makes changes to their checklists, we'll be able to see what was changed.
A few key things from the CAP documents pop out immediately:
1. CAP is being more thorough and details about its IQCP requirements. Take a look at its recommendation for the Risk Assessment:
"The laboratory director must consider the laboratory's clinical and legal responsibilities for providing accurate and reliable patient test results. Published data and information may be used to supplement the risk assessment, but is not a substitute for the laboratory's own studies and evaluation. The laboratory must involve a representative sample of testing personnel in the process of conducting the risk assessment. It is not necessary for all personnel to be involved.
"The risk assessment for laboratories with multiple identical devices must show that an evaluation was performed if there are differences in testing personnel or environments where testing is performed, with customization of the quality control plan, as needed.
"The QC study performed to assess the performance and stability of the tests must support the QC frequency and elements defined in the laboratory's quality control plan. The study must include data representing, at a minimum the maximum interval between runs of external quality control. The laboratory may use historical data during the risk assessment for tests already in place.
"For affiliated laboratories (e.g. systems) with integrated procedures, each accredited laboratory must have its own IQCP approved by the laboratory director. There must be records demonstrating that risks specific to the site were evaluated involving a representative sample of local testing personnel to conduct the risk assessment and that laboratory-specific QC data were used in the study to support the defined frequency of quality control. Laboratories may use data from other sites to supplement risk assessments and to support their findings."
Already you see CAP asking for more personnel to be involved in the Risk Assessment, that the frequency of controls in any study match proposed frequency of reduced QC, and that site-specific risks must be addressed for each lab, and site-specific QC data must be used for each lab.
CAP is filling in a lot of the blanks of the original IQCP regulation.
2. Not everyone gets to IQCP. From the Frequently-Asked-Questions:
"Why did the CAP limit the eligibility to use an IQCP to tests with internal control processes?
"While many of the elements of IQCP are not new for laboratories, the overall concept is a significant change. The CAP will limit the use of an IQCP to instruments or devices with an internal control for the 2015 checklist edition (with the exception of microbiology susceptibility, media, and identification systems; see FAQ #13 above) and will reevaluate this decision as we gain more experience with IQCP. This meets or exceeds the CLIA/CMS requirements and was approved by the CMS.
"The use of internal control systems has been accepted by the CAP previously. Laboratories may continue to use internal control processes, but must implement an IQCP to do so. For the microbiology tests mentioned above, the CAP has accepted alternative quality control practices that followed microbiology guidelines from the CLSI. These practices may continue to be used if an IQCP is implemented."
CMS, again, was pretty vague about who and what could implement IQCP. CAP is narrowing down the options to instruments and devices that actually run internal electronic controls. This is common sense - we shouldn't reduce QC if the device doesn't have any internal ability to monitor the functionality of the device - but that wasn't stated in the CMS memos. CAP is taking a harder line.
To help laboratories understand just what is and isn't eligible for IQCPs, CAP has developed their own IQCP eligibility tool. There's a flowchart with simple questions (that's the graphic included above). This is something that CMS has not done.
As readers know, we're not wearing rose-colored glasses when it comes to IQCP. We're probably more pessimistic about it than any other source. But CAP's IQCP looks to be one of the better implementations. If you're going to do IQCP, at least look at their guidance and follow their recommendations. That alone will reduce your risk.