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In this issue
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New guidance on lung cancer testing |
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HCV, CMV viral load—treatment, testing, timing |
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Missing transcripts, diplomas snag labs |
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Yeast, molds, and cell types in 2 benchtop guides |
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From the President’s Desk: At CAP ’13, countless ways to connect |
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In EHR world, LPL software still has its place |
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Laboratory-provider links software product guide |
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New attention on POC device disease transmission |
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With NGS, new hope for managing thyroid nodules |
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Clinical Pathology Abstracts |
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Anatomic Pathology Abstracts |
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Newsbytes |
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Q & A |
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Marketplace |
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Put it on the Board |
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Letters |
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Automated immunoassay analyzers |
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Automated molecular platforms |
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Bedside glucose testing systems |
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Chemistry analyzers for low-volume laboratories |
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Chemistry analyzers for mid- and high-volume laboratories |
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Coagulation analyzers |
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Coagulation analyzers—point of care, self-monitoring |
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Hematology analyzers |
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In vitro blood gas analyzers |
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Laboratory automation systems and workcells |
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Next-generation sequencing instruments |
| Software Systems |
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Anatomic pathology computer systems |
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Laboratory-provider links software |
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Middleware systems |
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Positive patient identification products |
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Missing transcripts, diplomas snag labs
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Anne Paxton
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.”
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“At some institutions they kind of hold the POC testing device hostage. ...That’s just one way to make sure you have it,” says Deborah Perry, MD, director of pathology at Children’s Hospital and Medical Center, Omaha, and pathologist at Omaha's Methodist Hospital.
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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. [more]
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