Missing transcripts, diplomas snag labs

The CAP accreditation program asks labs to submit a personnel roster every time they reapply for accreditation. “But that’s only every two years, so laboratory directors need to remember to check and make sure they’ve updated that document and have those credential documents on site for those people.”

Some lab directors have the misconception that they can know people are qualified even if they lack the paper. But be warned, Daniels says. “When CMS cites a condition deficiency for not having personnel documentation, they cite the issue but they also cite the lab director, because that is the person ultimately responsible for oversight. So I think the opportunity here is to make sure lab directors really understand that.”

Many times lab directors are surprised that falling short on this requirement amounts to a condition level deficiency. “That didn’t happen 10 years ago. But the regulation hasn’t changed. It’s just that CMS is now driving the point home. It’s crept into our world over the last few years, and we’re striving to make it right for all our labs. It’s very rare to find a person who’s actually not qualified. So it’s basically an exercise in making sure you’ve crossed the T’s and dotted the I’s,” Daniels says.

Inspection citations for lacking personnel transcripts or diplomas are not a widespread problem, but they are not rare either, says Earle Collum, MD, Region 6 commissioner for the CAP Laboratory Accreditation Program, and chairman and medical director of the Department of Pathology and Laboratory Medicine, St. Joseph’s Hospital, Phoenix, Ariz.

With the registry or temporary duty nurses on whom hospitals frequently rely, for example, “The registry will assure the hospital that these people are qualified to perform their duties as registered nurses, but the hospitals are still responsible for having information in their personnel files if that person is performing moderately complex testing. If the registry has that information and they want the person to do moderately complex testing, they can forward the credentials as well,” Dr. Collum says.

“It’s very much like when you want to qualify for a board exam after medical school. You wouldn’t have gone through a residency if you hadn’t gone to medical school. But they still want the medical school diploma as a matter of completeness,” he adds.

Dr. Collum has heard of instances in which a school has closed and the former student couldn’t get the transcript, and he says those have to be dealt with on a case-by-case basis. “Usually there is some way to do it. Either the school will provide some directions on how to get transcripts, or the person made an application that required the diploma 10 years ago and they may be able to get it that way. But one needs to show a conscientious effort and somehow assure that no rock has been left unturned to get the right documentation.”

The bigger problem, he points out, is that years ago, “we allowed nurses to use their nursing license as their credential, but, strictly speaking, that’s not acceptable, and I don’t think we’ve done enough to educate laboratory directors about this requirement.”

An additional issue can crop up with graduates of hospital diploma nursing programs, Dr. Hoeltge says. “I don’t know about all states, but I can tell you in my state of Ohio, a lot of nurses are non-baccalaureate nurses. They went to a hospital training program, they’re licensed in state, fully capable of doing everything an RN can do, but they don’t have a bachelor’s degree.”

“From a credentialing point of view, that’s an issue, because what the regulations mention is education from an accredited institution—so we’re talking about a bachelor’s degree or a transcript. Many of the hospital programs are combined with a college or university, so some of their credits are from college or university and others are from the hospital itself. As I read CLIA regulations, it may be that some hospital-based nurses do not have enough college education to meet the CLIA requirements.”

Dr. Perry says most laboratorians know they need the documents. The challenge is the nursing personnel do not understand it, and there may be difficulties getting the nursing staff to provide the documents to labs. “They may say, ‘I have the transcripts in Ohio and I live in Michigan, or it’s in my mom’s basement.’ So at some institutions they kind of hold the POC testing device hostage. We do that here. We will not allow a nurse or other personnel performing testing to have access to the POC device until they provide their transcript or diploma. That’s just one way to make sure you have it.”

A related and common deficiency the CAP accreditation program sees is documentation of annual competency, Dr. Perry adds. “There’s a checklist requirement that the competency of each person performing testing needs to be assessed twice in the first year, then annually” (GEN.55500). During on-site inspections last year, this item was cited as a deficiency 17.6 percent of the time—“even more frequently than the absence of personnel documents,” she says. In December 2012, the CMS released a new brochure to help address the issue of competency, “What Do I Need to Do to Assess Personnel Competency?,” available at www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/Downloads/CLIA_CompBrochure_508.pdf.

To protect the laboratory accreditation process, basic awareness of the personnel records requirement is key, Dr. Collum emphasizes. “We just need to make laboratories and CAP inspectors aware that personnel requirements do get special emphasis from other accrediting organizations and CMS, and to make sure our laboratories have provided those records.”

Anne Paxton is a writer in Seattle.