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Personnel paradox and more: POC pitfalls

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Charna Albert

November 2019—Point-of-care testing makes up only about 10 percent of all laboratory testing but the aggravation factor and number of people involved far exceeds that, said Deborah A. Perry, MD, medical director of pathology at Methodist Hospital in Omaha, Neb., speaking at CAP19 and calling POC testing “a whole different world.”

In a session titled “Point-of-care testing pitfalls: what you don’t know can hurt you,” Dr. Perry and Brad S. Karon, MD, PhD, professor of laboratory medicine and pathology and co-director of the point-of-care program at Mayo Clinic, used scenarios to illustrate point-of-care testing risks and how to mitigate them.

“Initially, people kind of let the point-of-care side of the world go to the medical technologists, and the laboratory medical directors hoped we wouldn’t have to worry about it too much,” said Dr. Perry. “But as we have watched the point-of-care testing volume and test mix grow, and have undergone on-site inspections, we now know that as the medical director it’s your responsibility to make sure it’s done right.”

“We’re here to tell you some of the frightful things that have happened to us in point of care, and hopefully help you avoid those,” Dr. Perry added.

Here is scenario No. 1: Nursing performs competency assessment for POC on career day, where competency is assessed for both waived and moderate-complexity testing. Some nurse educators performing competency have four-year degrees with less than one year of experience in POC, while others have associate’s degrees in nursing but many years of experience in POC. Some of the nurses being assessed work in different buildings under different CLIA numbers.

In a CAP inspection, the laboratory in this scenario would be cited for having nonqualified technical consultants sign off on competency assessments for its nonwaived testing and for completing competency assessments at a site other than where lab testing is actually performed, Dr. Karon said. For nonwaived testing, competency assessments must be done “at the site where the test is performed at each CAP and CLIA number,” he said.

“I’ve directed Mayo’s program for 15 years, and our nurses are perfectly understanding when we need to follow them around to all three clinics where they perform nonwaived anticoagulation testing to assess their competency,” Dr. Karon said, with a touch of humor.

Competency assessment is the No. 1 citation year after year, in the Laboratory Accreditation Program as a whole and in POC testing specifically, “and explaining why this has to be done can be difficult for point-of-care directors,” he said.

In point-of-care testing, the second most cited deficiency is for nonqualified technical consultants signing off on competency assessments for moderate-complexity testing.

Under CLIA rules, personnel performing and signing off on competency assessments for high-complexity testing must meet technical supervisor (often known as section or medical director) or general supervisor requirements. Technical supervisor requirements can be fulfilled with a doctoral, master’s, or bachelor’s degree in clinical laboratory, biological, chemical, or physical science and one year of training and experience in high-complexity testing. General supervisor requirements can be fulfilled with an associate’s degree in an approved science and two years’ experience in high-complexity testing in that area, such as microbiology, chemistry, or transfusion medicine.

For moderate-complexity testing, on the other hand, “the role of general supervisor does not exist; therefore, only a technical consultant or the CLIA medical director can perform and sign off on competency. Technical consultants must have at minimum a four-year degree and two years’ experience” or a doctoral or master’s degree and one year’s experience, Dr. Karon said.

“This is obviously somewhat of a paradox. High-complexity testing is high complexity; it’s supposed to be more complex. But our general supervisors with associate’s degrees can sign off on competency” for high-complexity testing, he said.

At the point of care, “many larger hospital-based programs do both waived and moderate-complexity testing,” Dr. Karon said. “In our practice, almost all our point-of-care coordinators have associate’s degrees and do not qualify as technical consultants.” If the laboratory medical director or someone else meeting technical consultant requirements doesn’t sign off on competency, “we have unqualified people overseeing competency for moderate-complexity point of care. Full disclosure,” he added, “three or four years ago, our program at Mayo Clinic did get cited for a nonqualified person performing competency assessment. It happened to me, and therefore I’m sharing my wisdom with all of you.”

On the other hand, hope may be on the horizon when it comes to the personnel paradox, said Dr. Karon, who is also a member of the Clinical Laboratory Improvement Advisory Committee. The CMS recently solicited public comment on personnel requirements, and a CLIAC working group was formed to make recommendations on a number of personnel issues related to CLIA. Though the timeline is uncertain, he said, the CMS could in the future standardize personnel requirements for technical consultant and general supervisor. (A summary report of the April 2019 CLIAC meeting is available at www.cdc.gov/cliac.)

Dr. Karon laid out five general rules for preventing competency assessment-related citations:

  • Ensure assessments do not exceed one year for waived and nonwaived testing.
  • Ensure new staff who perform nonwaived testing are assessed semiannually the first year of testing.
  • Ensure POC test systems are defined and all six elements of competency are used for each nonwaived test system. Competency assessment must evaluate the six elements defined by CLIA for each test system, including direct observation of test performance, monitoring the recording and reporting of test results, review of intermediate test results or worksheets, direct observation of instrument maintenance and function checks, employee analysis of PT or blind sample, and evaluation of problem-solving skills. For waived testing, laboratories can select from the elements.
  • Ensure it is clear which element was used when documenting competency assessment.
  • Ensure qualified individuals are assessing competency.

Scenario No. 2: Your human resources group insists on maintaining records for point-of-care nursing and respiratory therapy testing personnel, including diplomas, transcripts, and primary source verification, centralized in the HR department. You’re concerned this could be a problem for you in your upcoming CAP inspection.

“What documents are required for your CAP point-of-care inspector?” Dr. Karon asked session attendees.

Dr. Karon

When audience response was mixed, he explained that for CAP inspection all that’s needed is evidence that an institution’s primary source verification system (PSV) is effective. “I inspected large point-of-care programs that decided it’s easier to keep transcripts in the lab office,” he said. “You can choose to do that, but because CMS now allows primary source verification, the CAP accreditation program also says you can use PSV; you just have to prove it’s effective.”

At Mayo Clinic, more than 850 personnel perform nonwaived POC testing. If the CMS and the CAP accreditation program didn’t accept primary source verification for proof of diploma, “our coordinators would do nothing but bug people about their transcripts,” Dr. Karon said.

The CAP has tools to help laboratories keep track of POC testing personnel, including the laboratory personnel evaluation roster, a worksheet labs submit as part of the accreditation process. At Mayo Clinic, where the point-of-care program operates under its own CLIA certificate, Dr. Karon said, “all 850 of our nonwaived testing personnel are included on the roster, so we and CAP can figure out who is this person, what role do they have, are they a technical consultant, or are they just a tester? And how did we verify that they qualified? Did we ping their PSV and it worked? Did we ping their PSV and it didn’t work so we got a copy of their transcript on file?”

Where PSV does tend to fail is in verifying the educational credentials of personnel trained outside the U.S., a potential risk Dr. Karon outlined in the third scenario.

Scenario No. 3: You are inspecting a POC testing program. In this program, the nurse performing nonwaived testing has a translated transcript showing an international bachelor’s in nursing degree, but few credits in chemistry, biology, or physics. The transcript is translated into English and shows a terminal nursing degree issued from another country, but no equivalency evaluation from a nationally approved agency.

Inspectors in this situation, Dr. Karon said, would have to cite the program, since there is no evidence the nurse’s international nursing degree is equivalent to a bachelor’s in nursing degree obtained in the United States.

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