CAP TODAY Pathology/Laboratory Medicine/Laboratory Management
Charna Albert
December 2019—For point-of-care testing, perform proficiency testing on only one method or instrument unless your testing procedure says all patient samples must be tested on multiple instruments. And if a single IQCP is written for more than one POC testing location, account for all variations.
These and other tips come from a CAP19 session, “Point-of-care testing pitfalls: what you don’t know can hurt you,” presented by Deborah A. Perry, MD, medical director of pathology at Methodist Hospital in Omaha, Neb., and Bradley S. Karon, MD, PhD, chair of the Division of Clinical Core Laboratory Services, Department of Laboratory Medicine and Pathology, Mayo Clinic. They used scenarios to illustrate how best to approach PT, the IQCP, and CAP inspections for POC testing. (Part one is published in the November issue.)
PT has unique aspects related to point of care because point-of-care programs tend to employ high numbers of devices, said Dr. Karon, who is also co-director of Mayo’s stat labs and point-of-care testing programs. And in 2016 the Centers for Medicare and Medicaid Services said labs are “not allowed to report PT on more than one instrument or method unless that’s how all patient results are reported.”
“We always say treat and monitor PT like a patient specimen,” he said, adding, “It’s complicated because there are times when you cannot treat your PT like a patient sample. You certainly can’t refer it between labs A and B if they operate under separate CLIA licenses. Even if you confirm all point-of-care INRs over five with plasma, you can’t do that for PT if you’re crossing a CLIA license—and there is some risk for doing this within a CLIA lab unless the SOP is very clear on what situations require a lab confirmation of POC INR.” There are also practical considerations and limitations to confirmatory testing, he added. PT materials designed for whole blood INR may not work well for laboratory methods.
Second of two parts. Last month: Personnel paradox and more: POC pitfalls
Also tricky, he said, is how laboratories should handle PT for POC programs when they’re under the same CLIA certificate as the lab, and when they’re not.
With these two issues raised, he introduced this situation: You are a laboratory director for a stat lab and POC program (operating under the same CLIA number), both doing plasma PT/INR, and your POC program supports several dozen nonwaived whole blood POC INR meters.
The laboratory director in this situation could avoid sanctions related to performing PT on more than one method by ordering unique whole blood and plasma PT kits, Dr. Karon said. Other options: Order a plasma PT/INR survey and do a comparison between laboratory plasma and whole blood POC INR (alternative assessment for the nonwaived meters) using patient samples, or order a plasma PT/INR survey and use a PT/INR plasma Quality Cross Check product to test each of the nonwaived meters.
“Only perform PT on one method or instrument unless your procedure states that all patient specimens get tested on multiple instruments,” he said. “This applies to regulated, nonregulated, and waived analytes.” If a lab enrolls in a waived glucose PT survey and a nonwaived plasma/serum glucose PT survey under the same CLIA certificate, the PT products will be different, and that is acceptable. “But if it’s the same PT material, you can’t test both.” This affects labs that have multiple instruments and split lab/POC programs.
In 2017 the CAP accreditation program stopped requiring enrollment in PT for waived whole blood glucose or waived whole blood INR testing, “in recognition of the fact that we have lots of glucose meters, INR meters, and i-Stats in our institutions, specifically for glucose and INR, and the CMS will only allow you to buy one kit and test it on one glucose meter” per cycle, he said. “If an institution has 500 meters, it wouldn’t make sense to require that laboratory to buy a kit to test one of 500 meters every cycle. It would take 30 years to get through all the meters with PT.”
“But,” he said, “this is where it gets tricky.” Nonwaived glucose is regulated, and CLIA requires that labs be enrolled in PT for regulated analytes. INR is not a regulated analyte, but the Laboratory Accreditation Program requires PT enrollment for nonwaived INR testing. If a laboratory’s POC program is under a separate CLIA certificate and performs nonwaived glucose or INR testing, “even if you have 400 nonwaived point-of-care glucose or INR meters, you still must enroll in a PT survey,” Dr. Karon said. In this case, only report results from one of the instruments/meters per PT event.
A laboratory that uses more than one method for the same test should use the primary instrument for PT. As a general rule, Dr. Karon said, whichever instrument performs the higher test volume is considered primary, but ultimately it’s up to the laboratory director to designate which instruments are primary and which are secondary. “You can cross-check against the primary,” he said. Labs can use the CAP Quality Cross Check programs or develop their own cross-check procedure.
Multiple kits can be ordered under the same CLIA number, but the lab has to ensure it doesn’t run the same PT material on any other instruments before the due date provided on the result form. “That gets risky,” Dr. Karon said, “but some labs will do that as a way to make sure they’re checking their systems without violating PT referral.”
Dr. Karon turned to POC lab inspections and shared the following scenario: You are inspecting a hospital POC program (or leading a team and have asked a team member to inspect). The POC program has seven sites performing POC testing, five tests/instruments/methods (two nonwaived), and 30 nonwaived testing personnel. During the POC inspection you visit three sites (all doing just waived glucose meter testing), speak with three operators (all nurse managers familiar with POC procedures), and find no deficiencies. Two months later a CMS validation inspection of the POC program goes to the cath lab (a site you did not visit) and finds expired reagents, multiple unqualified testing personnel, and testing staff generally not knowledgeable about procedures. Among other citations, a condition-level citation is given to the lab director for failing to ensure quality system functioning and lack of oversight. What went wrong with your inspection?The inspector should have sampled sites in order to observe each of the five POC tests offered, rather than have visited only sites performing waived glucose meter testing, Dr. Karon said.
Inspectors “do have to sample,” because it often isn’t possible to visit every testing site, especially with larger programs, he said. “Six months ago, I inspected a site that had point of care at 55 to 60 sites under three different CLIA certificates. I’d still be there if I were going to visit every site.” If an inspector is going to sample, he advises picking higher-volume, higher-risk areas—his favorites are the ED and catheterization lab—and visiting waived and nonwaived testing sites. Some programs get so engaged in their nonwaived regulations they forget about their waived. “It’s rare, but it has happened in my inspections,” Dr. Karon said.