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IQCP worries? Help with what ends and begins

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Anne Paxton

July 2015—Technically, it’s true: The Centers for Medicare and Medicaid Services’ new program, the Individualized Quality Control Plan, is a voluntary, alternative option that clinical laboratories can use to customize their QC plans according to test method, patient population, environment, and personnel competency.

For much of the laboratory community, however, “optional” is the last word association they would make with “IQCP.” What many see is an entirely new quality control framework to grapple with every day; a looming cutoff date when the old, reliable system will become extinct; and potentially a major drain on their workday time and energy to cope with unfamiliar concepts of risk assessment.

It’s no wonder that, as CMS’ Jan. 1, 2016 implementation date nears, some laboratory directors are considering an Ativan prescription. But as a service to CAP-accredited labs—and with the aim of keeping panic at bay—the CAP has marshaled an array of resources to ease laboratories’ transition to IQCP. Already available are workbooks, algorithms, templates, lists of frequently asked questions, and other guidance from the CMS, the CAP, the Clinical and Laboratory Standards Institute, and the American Society for Microbiology. Now, the CAP Laboratory Accreditation Program has integrated IQCP requirements into the 2015 edition of the All Common Checklist, which at CAP TODAY press time was scheduled for release at the end of July.

Every lab accredited by the CAP has the expertise to do a risk assessment, Dr. Gerald Hoeltge says. “But now that risk assessment will have a structure and a table behind it.”

“For those who are writing individualized plans using IQCP, the Laboratory Accreditation Program wants to provide support, and so we’re offering nuts-and-bolts help,” says checklist commissioner Gerald A. Hoeltge, MD. “The All Common Checklist will have a brand-new section on IQCP that will itemize all the pieces that must be in place, and you can go to the College’s ‘Frequently Asked Questions’ page for a really clear preview of what you’ll need to do.”

There’s really nothing mandatory about IQCP, Dr. Hoeltge emphasizes. “Labs can continue to do the traditional two controls each day of testing. But we’re getting toward the end of the transition period, and more labs are going to be thinking about IQCP and working toward it.”

IQCP’s downside is undeniable. Establishing an IQCP in a laboratory involves a significant amount of work compared with what was required to implement the Equivalent Quality Control (EQC) program as developed by CLSI, says Adrienne Malta, MT(ASCP), MBA, senior manager of inspection services for the College.

The risk assessment component of the IQCP is new and will require additional work to identify, evaluate, and validate the laboratory’s proposed QC plan and frequency of internal and external controls. “Laboratories may have sufficient historical data to use as part of the risk assessment,” Malta says, “but there may be some risks that are identified for which the lab has insufficient data, and it will need to gather this data to complete the risk assessment.”

Even if a laboratory already has all the necessary data, the process of preparing a detailed risk assessment will be time-consuming. Potentially complicating the picture: instruments that use several different test cartridges. “It is possible that a separate risk assessment and IQCP will be needed for each cartridge type, even if many of the risks are the same for all cartridge types,” Malta says.

But there is an upside to IQCP too, she notes. It could save labs money. “Depending on the test and volume of requests, having to revert to traditional QC requirements can significantly increase the amount of external QC materials that must be purchased, particularly if an internal control was used daily and the external control was run only once or twice per month under the EQC guidelines.” If the test is a unit device test kit, the laboratory will need to purchase additional test kits over the course of the year to account for having to run daily external QC, further running up costs, Malta adds.

Flexibility is another plus. “The flexibility of an IQCP does allow laboratories the ability to personalize their QC processes and tailor them to the test systems in use,” she says. Laboratories may thus find QC options that better fit their risk management objectives.

One of the key differences between the IQCP and past approaches to QC is IQCP’s breadth. “The QC processes to date have been focused on the analytical component only—asking ‘Does the testing piece work?’” says Deborah A. Perry, MD, chair of the CAP Point-of-Care Testing Committee. “IQCP covers the whole process—the preanalytical and postanalytical as well as the testing process. In the past, from a regulatory standpoint, CMS did not look at the other pieces to the degree they will now.”

Dr. Perry

Dr. Perry, too, stresses that IQCP is voluntary. “The CLIA guidelines say to do two levels of QC every day of testing. So if your lab wants to do that instead of an IQCP, that is fully acceptable. Those are your two options as of January 2016.”

However, IQCP is likely to draw far more participants than other forms of compliance with QC requirements. “Most will follow IQCP for at least some of their testing,” says Dr. Perry, director of pathology at Children’s Hospital and Medical Center in Omaha, Neb. “Two levels of QC per day is a lot of quality control with point-of-care type testing. So I think in that world and in microbiology, for microbe identification and susceptibility testing, people will be highly likely to develop an IQCP.”

Some tests are eligible for IQCP and some are not. “The first thing labs have to do is make sure the tests they’re considering for IQCP are eligible,” Dr. Perry says. As helpful resources, she points to the eligibility criteria published by the CMS and the CAP as well as a one-page algorithm worksheet the CAP has drawn up (see page 78 for list of resources).

From the point of view of the CAP accreditation program, IQCP has special significance because CMS regulations on IQCP actually have two parts, Dr. Hoeltge says. “The option to customize one’s own QC system is one, but the other is the elimination of the EQC alternative.” The CAP never embraced CLSI’s EQC as it was developed, but a number of checklist requirements were based on the EQC model, he explains. For example, some checklists have a requirement for non-waived testing that allows an accredited laboratory to use electronic, procedural, or built-in controls to meet the daily QC requirement. “That kind of formulaic checklist language is going to disappear Jan. 1 because EQC disappears Jan. 1.”

After that date, the CAP will limit the eligibility for use of an IQCP to testing that meets both of the following criteria: 1) nonwaived tests that employ an internal (electronic/procedural/built-in) QC system (except that microbiology laboratories may implement an IQCP for media and reagents used for microbial identification and susceptibility testing as defined in the checklist); and 2) tests performed in specialties other than anatomic pathology and cytopathology (unless such a test can be assigned to a different CMS subspecialty—for example, FISH testing, which may be classified as either histopathology or cytogenetics).

Labs can continue to make use of the built-in controls if they want, Dr. Hoeltge adds, but they’ll need to craft their own IQCP to do it and be accredited. “That’s a really key aspect of what the College is doing to prepare,” he says. “It’s not just that the Laboratory Accreditation Program is there to help labs write an IQCP. Labs have to know that some of the familiar things in the checklist that we’ve been using and counting on are going to disappear Jan. 1.”

Beginning this summer, the 2015 edition of the checklist does put restrictions on what labs can do with regard to the IQCP. “No. 1, it only applies to nonwaived testing. And No. 2, it can only be done in those states that permit it,” Dr. Hoeltge says. (The state of California recently approved the use of IQCP. Kentucky and New Jersey are not allowing it, according to CAP checklist editor Lyn Wielgos, MT(ASCP).) “This means that those laboratories must follow the default CLIA regulations for quality control at a minimum [two levels of external controls per day of patient testing, or more frequently for some types of testing, such as coagulation and blood gas testing] or more stringent regulations if defined by the state,” Dr. Hoeltge adds.

The third restriction on the IQCP is that anatomic pathology and cytology are excluded, Dr. Hoeltge says. No. 4 is that the IQCP must be used on devices with an internal control process, or in microbiology testing. “For this first foray into IQCP and accreditation requirements, the Laboratory Accreditation Program supported the two areas of microbiology and point-of-care testing. That’s what most labs are interested in right now. In the future,” Dr. Hoeltge says, “we may have checklist requirements that will apply to a broader range of tests.”

No specific IQCP format will be required to meet CAP checklist requirements. Laboratories will be allowed to develop their own model or use other resources, such as CLSI guideline EP23-A, the CMS guidance, manufacturer protocols, or other commercially available products. Laboratories will, however, need to complete CAP forms that list and summarize their IQCP plans for inspector use during an on-site inspection. The CAP is also working collaboratively with the ASM and the CLSI to produce templates for developing an IQCP for microbiology.

One other important feature of the checklist requirements is that the accreditation program will not require laboratories to validate their IQCPs. “The reason is that you’re basing your QC on a personal assessment of risk that’s altogether different from compliance with external requirements. So you’re not going to have to validate your IQCP plan. The accreditation program will simply expect labs that chose to write an IQCP to do it well,” Dr. Hoeltge says. That’s also why the College has been diligently offering guidance and alerts so that laboratories will have access to expert tools when preparing their IQCPs.

It’s true that the kind of risk assessment the IQCP will require is a lot of work. However, Dr. Hoeltge doesn’t view risk assessment as something new or overly challenging. “Risk assessment isn’t difficult. There’s a method to it, and one works through it step by step and comes up with a picture of those variables that are most important and determines how to manage those variables. It’s not something labs haven’t been doing for a long time. Every lab accredited by the College has the expertise to do a risk assessment if they choose to. But now that risk assessment will have a structure and a table behind it.”

“The better question is: Is it worth it?” he says. “And it surely can be, especially when one has multiple devices that are doing the same tests. So the investment in the time and effort at this point can pay long-term dividends for labs.”

Dr. Hoeltge thinks labs are well advanced down the path to IQCP. “Some are going to put it off awhile, but I do believe that most medium and large labs will find that IQCP will help them.” Small labs that are doing a lot of point of care on identical devices or having identical test methods going on in multiple parts of the hospital will also find IQCP useful, he says. “This would be especially true in microbiology. It’s a lot of extra work to do QC on each batch of media or each time you’re doing a test for antimicrobial susceptibility testing. And there are good ways to do that through an IQCP. So most every microbiology lab will want to look into IQCP for media QC and for AST QC.”

The IQCP arose from a sense that the old EQC program was inadequate, says Christopher Lehman, MD, a member of the CAP Standards and Checklists committees. The EQC rules were published in 2003 in response to manufacturers who felt the QC requirements under CLIA were too stringent for their instruments that had some level of internal QC. “But the EQC rules were pretty roundly criticized, because the algorithm they had created really had no statistical basis to support it.” The EP23 standard for assessing risk from a patient point of view was a partial way of addressing that critique, and the CMS gave its approval to the EP23 document, but it set a date on which EQC would sunset: Jan. 1, 2016.

Dr. Lehman

Dr. Lehman, medical director of clinical laboratories at the University of Utah, was part of the workgroup that developed the plan for how to implement IQCP for CAP members. “The reason why I and other members of the Checklists Committee supported the concept of beginning with internal QC is because that’s where EQC originated,” Dr. Lehman says. So the checklist standards are restricted to assays or instruments that have internal QC.

“From my perspective, we have three points of view for approaching this,” he says. “One, we want to make sure we’re protecting patients. Second, we’re protecting laboratory directors under CLIA rules. And third, we have to have a way of inspecting this. Since nobody has experience with evaluating IQCP plans, we felt we have to have a basis, and starting with assays that had some kind of internal QC running was a good place to start.”

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