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Tips for meeting the tough new cytology regulations.

You may be forgiven if your head is still spinning even after the long-awaited CLIA regulations arrived.

Anticipation of new Federal regulations has had the cytology in a panic since 1988 because of the large number of measurement written specifically of our discipline.[1] The magnitude of the statues makes it hard for most laboratories to know where to start implementing methods of compliance.

Our laboratory is located in a 300-bed medical center at a Midwestern university. Our first sttep in compliance with proposed CLIA '88 was to determine which regulations were already being met. Quality control of the Papanicolaou staining process, for example, was in compliance because it was also required for CAP accrediation. I listed all procedures that were not up to the standards and decided to correct them one at a time. They fell under the general headings of proficiency testing (PT) and quality assurance.

* Proficiency testing. All lab employees who examine Pap smears must be enrolled in a PT program approved by the Health Care Financing Administration (HCFA) by Jan. 1, 1994. To date, no program has been approved to administer cytology PT. The content and form of the examination, however, have been decided.

According to published CLIA rules, pathologist and cytotechnologies who screen cytology slides must take an annual proficiency test. Each lab will receive a yearly on-site test that may or may not be announced. Labs will be notified of the time of each announced on-site test at least 30 days in advance. Additional test will be held as needed in each state or region for testing individuals who missed the on-site test and for retesting those who failed previous exams. The exam will include 10 one one-slide gyn cases. The passing score is 90%.

This doesn't mean a lab can miss exactly one of the 10 cases and still earn a passing grade. Pathologists, moreover, will be scored differently from cytotechnologists. The scoring system (Figure I) does not assign 10 points to each answer. A correct answer is worth 10 points. An incorrect answer is valued at 5, 0, or -5 points, depending on the degree of difference between the answer given and the correct one.

Those who fail an annual test must be retested no more than 45 days after being notified of failure. The second test, for which a passing score is again 90%, will also consist of 10 slides. For any employee who fails the second test, the laboratory must provide documented remedial training and education in the area of failure. The lab must assure that all gynecologic slides evaluated after notification of failure have been reexamined and documented until the individual is retested, on a 20-slide test this time, scoring at least 90%.

Any employee who fails the third test must stop examining gyn slide preparations immediately upon notification of test failure. The individual may not resume screening until he or she has received at least 35 hours of documented, formally structured continuing education in diagnostic cytopathology that focuses on the examination of gyn preparations. The retest that follows the CE requires a 90% score on 20 slides.

I initially felt the PT rule could be ignored until it was time to take the proficiency exam. I soon realized that a program of remedial training had to be in place in case of failure. I wrote a plan that includes participation in a gynecologic cytopathology review course and a required number of case reviews (on a double-headed microscope) with the pathologist who is our laboratory director.

* Quality assurance. The key to compliance with quality assurance regulations is good record keeping. Everything must be in writing. We developed a QA manual separate from our procedure manual for easy reference. A file drawer or at least a large notebook is needed to contain the large quantity of documentation. Having an effective computer system is essential for labs that are not prepared to hire extra staff to enter data and track all this information.

* Workload. Documentation is especially important in workload recording. Under CLIA '88 regulations, no person may screen more than 100 previously unscreened cytology slides per day. Any slide that has been prepared with methods covering one-half or less of the slide area-including cytocentrifuge slides, 25-mm filters, and similar monolayer preparations counts as only half a slide in figuring screening volume. The maximum of 100 slides may not be examined in less than eight hours.

Cytotechnologists in our tab do more than screen. They prepare and stain slides, enter data on the computer, collect patient specimens, teach pathology residents, and do research. When an employee works less than eight hours a day screening slides, a formula is used to prorate the number of slides that may be examined. Multiply the number of hours spent examining slides by 100 and divide by 8.

The screening limit is intended as a maximum, not as a performance target. Labs must use PT and QA indicators to set lower individual limits for every screener who has not proved capable of doing the maximum number. These limits must be reassessed at least every six months and adjusted when necessary. Labs must show evidence of having an adequate number of cytotechnologists on staff to handle the annual volume.

Using a computer facilitates documentation tremendously. A report of the daily workload for each technologist is quickly run. We use a simple log charting the number of slides screened by every technologist each day and run it monthly. Without a computer, workload documentation may take the form of logs written by individual technologists, as long as the total number of slides equals the lab's total volume.

* Moonlighting. Because labs must furnish evidence of the number of slides screened, it's hard for an individual technologist to screen a large number of slides at more than one laboratory without getting caught. If a technologist scrutinizes 90 slides at one lab and 30 at another within 24 hours, both labs are at fault and could be penalized. It is each lab's responsibility to document the number of slides screened each day by its employees--no matter where they are.

The Federal government is not the only one watching. New York State has its own workload limits per hour as well as per day, with monetary fines to be paid by the offending labs and/or cytotechnologists. In that state, no more than 80 one-slide smears or 50 two-slide smears may be read per day. The hourly limit is 12.5 one-slide gynecologic smears. Labs can apply to the state for permission to exceed those limits by as much as 10% per individual.

* Rescreening QA. One of the most widely used (and debated) QA measures is the CLIA stipulation that 10% of negative gynecological cases be rescreened by an anatomic pathologist or cytotechnologist with at least three years' experience before reporting results. Documenting that requirement is as easy as one keystroke. Our computer program used for diagnostic entry by cytotechnologists, for example, includes the question, "Is this a QC case?" The answer is a simple "Y" or "N." At any point we can generate a printout listing all QC cases for a given period of time.

CLIA '88 regulations require some gynecologic review cases to involve specimens taken from patients classified as being at high risk for cervical cancer. The laboratory is limited in its ability to obtain this information, however. Only if someone at the same institution previously interpreted an abnormal Pap smear or cervical biopsy can it be known with certainty that a patient is indeed at risk. Having computer access to the patient's record at the time of screening is helpful in this regard. We ask our clinicians to identify high-risk patients in a comment added to the computer order or by marking a checkbox on our Pap smear request slip.

According to new Medicare guidelines, Pap smears must be identified and billed with codes that classify patients according to whether the smear was collected for screening or follow-up.[2] Knowing and using CPT codes helps identify high-risk patients.

* Abnormals. According to CLIA requirements, once a patient's Pap smear is found to be a high-grade lesion (moderate dysplasia) or worse, all her negative smears done within the previous five years must be rescreened if available either on-site or in storage. The rescreening may be done after the abnormal case has been reported. If discrepancies that would affect patient care are found, the lab must notify the patient's physician and issue an amended report. A statistical count must be recorded for all rescreened cases.

In our lab, we document rescreenings of previous negatives in a written log. Amended reports are noted in the computer file as part of the patient's history.

* Follow-up QA. The new regs state that statistics must be kept on cyto/histo discrepancies and abnormal Pap smears that have not had follow-up. To correlate our cytology and histology results, we use a computer-generated surgical accession log. We call up the cytology results for all patients who also had surgical specimens taken. The diagnoses are compared in a weekly report (Figure 11). When the results do not correlate-defined In our lab as differing by more than one step in diagnosis--the case must be reviewed and documented. The reason for the discrepancy must be noted along with any action taken.

We count the number of abnormal gynecologic cases for which histology results were unavailable or where no histological sampling was done. Any abnormal Paps found not to have been biopsied are documented. In cases of moderate dysplasia or worse, we notify the clinician. A simple natural language notation "dysplasia," for example) or SNOMED code search of the computer files for all Pap smears with diagnosis of dysplasia or carcinoma will locate the desired cases. Standardized nomenclature of medicine (SNOMED) codes indicate diagnoses and the specific sources of specimens. A check can then be made for the existence of surgical specimens.

All unsatisfactory cases must be documented. This includes counting unsatisfactory specimens (because of incorrect patient identification, for example) as well as uninterpretable smears. For accessioned cases, the computer is again instructed to search; in this case, for all Pap smears in which "unsatisfactory" is part of the diagnosis.

Federally mandated volume statistics must include the total number of cases processed as well as classification by specimen type and diagnosis. To program the computer to do volume statistics, it may be necessary to create a miscellaneous category for cases beyond the common specimen types and diagnoses.

* Screeners' records. Individual statistics for all screeners are to be kept for two years and compared with statistics derived from screeners in the laboratory overall. Any substantial difference between an individual's diagnosis rate and the overall lab rate must be investigated. The precise amount is left to each lab. The reason for deviation and any corrective action must be documented.

CLIA '88 requires the use of descriptive nomenciature for all results. The use of Bethesda terminology[3] in the gyn report satisfies CLIA. A system of descriptive nomenclature for cytologic diagnosis, Bethesda includes statements regarding specimen adequacy and the categorization of specimens within normal limits and beyond them. Bethesda terminology is used for proficiency testing.

We built diagnostic codes for our case signout procedure that use mnemonic abbreviations ("dys" for a low-grade squamous intraepithelial lesion or mild dysplasia, for example) and numbers. The use of a specific system is suggested, not mandated; it will not be enforced in inspections.

* Inspections and state regs. The American Society for Cytotechnology conducts inspections for HCFA. What happens during an ASCT inspection besides having to show QA documentation?

A team of cytotechnologists and pathologists rescreens at least 0.1% of the lab's annual gynecologic volume. In a lab that analyzes 50,000 Pap smears per year, at-least 50 random cases are rescreened. When deficiencies are noted, the lab is given time to comply with appropriate regulations. Sometimes reinspection may result. By implementing all requirements fully as soon as possible, laboratorians may avoid the painful learning experience that an unprepared-for inspection can provide.

At press time, 38 states had enacted some form of clinical laboratory regulation or had bills pending that would do so.[4] Federal and state regs often differ substantially. Laboratories must comply with the more stringent one in their own states.

The implied intent of the CLIA '88 cytology regulations is to improve patient care. Carefully choose methods of compliance that will not overburden your cytology lab. Manual tasks, such as tallying items, are best left to computers. Record the amount of time spent on work related to quality assurance and count it as either constant or variable workload in computing productivity reports. Keeping good records will help you justify and maintain adequate personnel to meet increasingly tight regulation. [1] Regulations Impementing the Clinical Laboratory Improvement Amendments of 1988 (CLIA '88). Federal Register 57 (40): 7137- 7186, Feb 28, 1992. [2] "New billing codes, coverage rules issued for Pap smear screening." National Intelligence Report 3(4), July 30, 1990. [3.] National Cancer Institute. The 1988 Bethesda system for reporting cervical/vagina cytologic diagnoses. JAMA 262(7): 931 934, Aug. 18, 1989. [4.] Headley, D (Government Relations Committee, American Society of Clinical Pathologists) Personal communication, March 2, 1992.
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Author:Allen, Karen A.
Publication:Medical Laboratory Observer
Date:May 1, 1992
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