CAP cedes little to obtain deemed status under CLIA.
That authority, granted by the Health Care Financing Administration (HCFA) last June, recognizes CAP as having fulfilled "all the requirements necessary to be granted deemed status under CLIA."
* No substantive changes. "I don't think there are any substantive or philosophical differences in our program today, compared with what was there before we applied for deemed status," says William Hamlin, M.D., the pathologist who chairs CAP's Commission on Laboratory Accreditation (CLA). He concedes that the new strictures will require the program to be "somewhat" more regulatory in its approach, but says its basic emphasis will remain on the overall improvement of clinical lab performance, not on punitive measures.
"I strongly believe, as do many other members of the clinical laboratory community, that if you are going to improve quality, you must make people feel that actions are taken for that purpose --and not to produce jail time," Hamlin says. He adds that one upshot will be the extra paper flow required to document the investigation of complaints received from such disparate sources as newspaper articles and disgruntled former employees.
Official notice of CAP's deemed status was still awaiting publication in the Federal Register at this writing. Bureaucratic delays could hold up that notice for several more months, but all key issues in need of agreement have already been hammered out.
For example, sources say deeming authority means that HCFA personnel will not "routinely" survey CAP-accredited laboratories. The agency will, however, be able to make unannounced inspections if it receives virtually any type of complaint. Lab directors have reported numerous cases of HCFA surveys that stretched out for several days; Hamlin says the arrangement is the closest thing to what might be considered a "concession" by CAP in its bid for deemed status.
* New checklist questions. Still, CAP gave ground on other fronts as well. HCFA officials have directed the group's laboratory accreditation program to strengthen its checklist of questions, more than 150 of which will be new and many others modified. These questions cover patient test management, quality control, personnel, and quality assurance.
Additional points up for discussion centered on cytology. In negotiations with HCFA, CAP agreed to meet such specific requirements as those for a 10% review of negative Pap smears. CAP reports, however, that HCFA relaxed its stipulation for a "random" 10% review in favor of a "directed" review in the same percentage of cases. CAP members note that pathologists conducting directed reviews will set criteria to concentrate on negative smears from higher-risk groups. Following is a rundown of other aspects of CAP's deemed status authority and ways it will affect the group's inspection efforts:
Anatomic pathology. A new checklist item says pathologists must perform microscopic examinations for diagnoses and state in writing that such exams were conducted. CAP advises that surgical pathologists who employ pathologist assistants to do gross exams should carefully review their activities. Directors need to document the education, training, and experience of these assistants and provide them with a detailed procedure manual. Further, pathologists must clearly state that PAs may examine certain tissues and that the pathologist must examine all others. These requirements are due to the Centers for Disease Control and Prevention's interpretation of CLIA rules.
JCAHO involvement. The Joint Commission on Accreditation of Healthcare Organizations was also granted deemed status authority by HCFA in August. The Joint Commission will continue to send lab surveyors to observe a percentage of CAP on-site inspections; the College says it will notify inspectors and directors in writing if they are set to be visited by a JCAHO observer.
Cytopathology lab inspections. This area has been considered volatile due to reports of false-negative Pap smears and overworked personnel in 'Pap mills." A working group including members of CLA and the CAP Cytopathology Resource Committee is developing recommendations to improve the quality of these inspections. Under consideration: the use of a cytotechnologist as an inspection team member who would review a limited number of slides on site, and requiring an independent, retrospective review of a large number of slides if evidence suggests a problem. The CLA may also require accredited laboratories to participate in the Performance Appraisal Program of interlaboratory comparison in cytopathology, which would require an addition to program resources.
Accreditation turnaround. For lab directors, the most crucial change is that inspectors will have to arrange their visit dates within 30 days of the lab's fixed accreditation date. That will be an adjustment from more lenient times when both CAP and JCAHO accepted some lapses in the 24-month inspection cycle. Regarding lab inspectors, the big change is that they must leave accurate, completed summation reports with the director. That starts the countdown on the post-inspection process, which must be finished within 120 days.
Reproductive laboratory accreditation. CAP, in conjunction with the American Fertility Society (AFS), conducts an accreditation program for reproductive laboratories. CAP's deemed status presents a challenge because those facilities are subject to laws unrelated to CLIA. Embryology procedures, for example, are not subject to CLIA inspections but are covered under a 1992 statute whose implementing regulations are still being drafted. CAP and AFS are developing a model certification program for such facilities. Meanwhile, reproductive labs that perform procedures falling within CLIA specialties and subspecialties must obtain CLIA certification. CAP reports that it has granted accreditation to about 30 reproductive laboratories and that about 50 more are being processed.
* The road ahead. Overall, CAP officials are confident that their negotiations with HCFA representatives have produced only minimal changes in the way laboratories accustomed to dealing with the College go about seeking accreditation. Still, many twists and turns lay ahead on the road to full implementation of the 6-year-old CLIA statute, and the potential for miscommunication looms large.
One telling factor will be how attentive Government officials remain to industry input. Were members of the independent Clinical Laboratory Improvement Advisory Committee "spoiled" by rubber stamps on their early recommendations? Has the Government turned a deaf ear to advisors who resist additions to the moderate complexity testing category for "accurate and precise" technology? Observers offer differing predictions for 1995.
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|Title Annotation:||College of American Pathologists; Clinical Laboratory Improvement Amendments of 1988|
|Publication:||Medical Laboratory Observer|
|Date:||Jan 1, 1995|
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