Missing transcripts, diplomas snag labs

Anne Paxton

April 2013—The paperless office may be just around the corner, and virtual reality may lie ahead too. But for the time being, when it comes to demonstrating that personnel have the required educational qualification to perform nonwaived point-of-care testing, the Centers for Medicare and Medicaid Services and the CAP have a message for laboratory directors: Primary documents are king. For accreditation under CLIA, it’s not enough to know personnel are qualified because of their certificate or license; you have to prove it with copies of their transcripts and diplomas.

For nonwaived point-of-care testing, laboratories are inspected with two checklists containing personnel requirements: the laboratory general and the point-of-care testing checklists. Laboratory general requirement GEN.54400 addresses personnel records and what must be in each file, explains Deborah Perry, MD, director of pathology at Children’s Hospital and Medical Center, Omaha, and pathologist at Omaha’s Methodist Hospital. “There are nine things listed there, and items such as dates of employment, license or certification, continuing education, and other areas are usually covered. The one that laboratories often get held up on is the second item: copy of academic degree or transcript.”

Last year, in fact, during on-site inspections it was one of the most common accreditation deficiencies, recorded 7.2 percent of the time, says Dr. Perry, who is chair of the CAP Point-of-Care Testing Committee. “It’s a pretty high number when you look at all the checklist items we have.” The point-of-care checklist item, POC.06850, says labs must have records demonstrating “there is documentation that all staff have satisfactorily completed initial training on all instruments/methods applicable to their designated job.” Records of training must be available in their personnel files.

The CMS requires the laboratory to have the diploma or transcript of anyone performing laboratory testing, whether inside or outside the laboratory. An entire list has to be maintained, together with documentation that the people have been trained on whatever point-of-care device they’re using, proof of competence assessed semiannually in the first year and annually thereafter, and academic degree or transcript. That can mean hundreds or even thousands of academic records. “We have around 100 people performing POC testing at Children’s Hospital even though we’re only a 120-bed hospital,” Dr. Perry points out.

Although it’s technically performed at the bedside, most point-of-care testing is under the direction and CLIA license of the laboratory and thus the lab director. Personnel requirements affect everyone, therefore, not just the medical technologists in the lab but also the nursing personnel and patient care personnel—whoever is performing the actual testing.

When an inspector comes in during a laboratory inspection and asks the laboratory manager or POC coordinator to show all the personnel records, a spot check may show records are missing. “They can randomly pick five or 10, and if the lab inspector pulls one out that doesn’t have the degree or transcript, then you have failed that requirement.” A rate of seven percent, Dr. Perry says, means this happens not infrequently.

But a glance at the AACC listserv for point-of-care testing coordinators shows that within the hospital, there is sometimes a distinct lack of understanding about the possibility of being cited. Says one commenter: “It was extremely hard to convince my Human Resources office that they could not use 3rd party verification and had to have a diploma or transcript.” Another: “The nursing exec team feel that the diploma/transcript requirement may not be realistic.” A rationale that is frequently heard: “Licensed personnel have to have a degree in order to be licensed, at least in our state, so why do we have to have their diploma?”

It’s been at least a year since the CMS stepped up its scrutiny of the actual personnel file documents, says Gerald A. Hoeltge, MD, former chair of the CAP Laboratory Accreditation Program Checklists Committee.

“In the lab testing personnel area there was a discovery at CMS’ end that some of the third-party credentialing agencies have had imperfect records. They’ve credentialed people who didn’t do the training appropriately. With certificates that should only be awarded to an individual with a bachelor’s degree, CMS discovered some of those certificates were invalid.”

“It was spotty, but it was a real gap. That means the CAP inspection program now has to look to primary documentation, and not take a third-party credential to prove educational qualifications. Personnel documentation is a real focus of the CMS, so the Laboratory Accreditation Program has to be consistent in the way it looks at personnel records,” Dr. Hoeltge says.

That need was underlined when CMS’ own validation surveys started citing laboratories for missing records where CAP inspectors had not. The CAP checklist contains requirements associated with phase one and phase two deficiencies, while the CMS inspections use a different nomenclature for deficiencies, says Amy Daniels, MT(ASCP), CAP’s manager of investigations in the accreditation program. “They call them ‘standard level,’ which are less severe, and ‘condition level,’ which are more severe.”

The CMS does a small portion of simultaneous validations the same day as CAP inspections, but only about five per year. “We usually have about 100 to 120 validations a year, and most are within the 90 days following our inspection. Any time CMS cites a condition level deficiency, CAP needs to show a comparable deficiency in that area,” Daniels explains.

Part of her job is to analyze the disparity report from the CMS that arrives every year in August, Daniels says. “If CMS cites a specific condition for lab testing personnel and it was because they lacked education documentation, and the CAP inspection team also cited the specific question about personnel qualification, that would be a match. It would not be a disparity. But if CMS cited that and the CAP team did not cite it, that would be seen as a disparity against the College.”

“The trend I’m noticing in these valuations and these disparity reports is that about half of our disparities are related to personnel standards. Our disparity rate is not that bad. But this has definitely brought to the forefront that we need to improve.”

CAP inspectors generally are told to do a random check of a subset of personnel files. “We don’t make them check every person,” says Daniels, “but we do inspect all types of labs. For a small lab that has only a handful of personnel, they would probably check all of the files. But in some hospital or reference labs you can have hundreds of personnel.”