A model state program for cytology PT.

The author is chief of the Division of Laboratory Licensure, Certification, and Training in the Laboratories Administration of the Maryland Department of Health and Mental Hygiene.

Maryland improved on established models to develop a proficiency testing program with standardized diagnostic terminology and fair grading.

From 1987 through the spring of 1988, the national and local news media, women's groups, and Congress strongly attacked the quality of the nation's clinical laboratories in general, and cytology labs in particular.

An award-winning investigation published in the Wall Street Journal' first raised alarm nationally. Then in the Maryland-Virginia-D.C. region, cytology labs were indicted throughout a weeklong series of televised reports2 that also received national attention and acclaim.

These media accounts blasted the Federal and state governments for failing to provide the statutory and regulatory structures needed to insure testing quality.

In response, the Senate Labor and Human Resources Committee held hearings, which drew on the televised reports and on newly gathered testimony about misdiagnosed Papanicolaou-stained slides. The hearings ended with a call for increased laboratory regulation.3

I was interviewed for the televised reports and attended the Senate proceedings because I oversee a division of state government that regulates cytology laboratories. When the Maryland General Assembly and the state health department accepted the challenges from the media and Congress, I was well positioned to play an active regulatory role.

In early 1988, the assembly passed a law requiring strict standards for cytology laboratories.4 Maryland's new law specifically addresses many of the potential abuses and problems identified by the national press. Among other things, the law:

Prohibits paying cytotechnologists on a piecework basis.

Limits the number of slides a cytotechnologist can read.

Requires rejection and records of all unsatisfactory specimens.

Precludes screening slides outside a licensed laboratory.

Prohibits physicians in Maryland from submitting cytology specimens to out-of-state labs that do not hold a Maryland permit.

Calls for a state-run cytology proficiency testing (PT) program.

The job of drafting the regulations to implement the many sections of the law fell to my division in the health department's Laboratories Administration. This article explains how we overcame obstacles and introduced an improved state-run cytology proficiency testing program.

After reviewing the available literature on the subject, I concluded that Maryland's PT program should be based on the technical criteria proposed by Penner 5-6 and first implemented by New York State. The criteria require any cytology proficiency testing program to use standard diagnostic terminology, evaluate cytology as it is practiced on a day-to-day basis, draw on actual patient slides for test material and interpretations, have experts in cytology evaluate and reach agreement on diagnoses for these test materials, use comparable test materials within the group being examined, and be fiscally practical and enforceable.

First I formed an advisory panel of technical experts and representatives from the regulated industry (cytology laboratories). Such a panel would provide the state with expert advice and also help build broad acceptance of the proficiency testing regulations before they were officially proposed, published, and presented at a public hearing. 7

The panel consisted of seven pathologists-three from hospital labs, three from private labs, and one from the state public health lab-three cytotechnologists, myself, and two members of my staff. Two of these panel members also represented the Maryland Society of Pathologists and the Maryland Association for Cytotechnologists.

We met nine times between March and December 1988 to work on regulatory standards and PT protocols. First we reviewed New York State's cytology PT program and attempted, where appropriate, to model Maryland's program upon it. That would promote interstate standardization of cytology PT and possibly lead to accrediting reciprocity between states.

While panel members agreed that the New York program worked, they also saw a need for improvement in the areas of standardizing terminology for PT slide diagnoses and in grading the diagnoses.

Improving terminology proved to be the panel's biggest problem. We spent eight months deliberating before we finally decided on the diagnostic categories and terminology in Figure 1. We believe it is a major improvement over New York's categories, which omitted cytology specimens deemed "unsatisfactory."8 We included this heading because Maryland's law specifically requires cytology labs to identify and document unsatisfactory specimens.

Developing simple but fair grading systems was the second most difficult problem to solve. Since Maryland's PT program must test and grade both cytotechnologists and pathologists, two corresponding grading systems were created (see Figure 11).

The only real differences between the two grading systems are that pathologists are graded more stringently than cytotechnologists in the "significant epithelial atypia" and "cancer present" diagnostic categories.

Each set of test materials in Maryland's PT program consists of 10 patient slides. Both Maryland and New York require a minimum score of 90 per cent by pathologists for laboratories to pass.

On a scale of 10 (perfect) to 0 (totally incorrect), the Maryland scale provides an intermediate point value of 5 for a minor error. Thus an examinee can make up to two minor errors without failing the test.

In order to evaluate cytology as it is practiced, only pathologists in laboratories without a cytotechnologist receive a set of test slides to screen. Pathologists in labs with cytotechnologists are graded on test sets previously screened by a cytotechnologist. Each pathologist and cytotechnologist receives an individual grade.

Each laboratory receives a grade derived from the average of grades for all of the lab's pathologists. If a lab fails because one pathologist fails, individual grading allows the failing pathologist to be singled out for retesting and/or retraining. Individual cytotechnologists who fail are also identified for mandatory retesting and/or retraining.

Anyone suffering a second failure in the same testing cycle must cease reading slides and obtain approved retraining before he or she is allowed to take another test.

Where to find the test materials was another problem to be overcome. Government agencies in Maryland, as in most states, do much of their purchasing through an open-bid system. Initially, it was suggested we seek bids from cytotechnology schools for complete sets of proficiency test slides. The advisory panel strongly opposed this procurement system, however, fearing that the quality of the slides might diminish if they were provided by a low bidder.

The state finally decided to obtain test slides from individual physicians and labs in Maryland, and to have all selected slides evaluated by a panel of expert Maryland pathologists.

Proper evaluation of cytology test slides is extremely important to the integrity of a PT program. Maryland followed the strict evaluation criteria presented in Figure III, which are identical to the New York guidelines, except for the consensus method we use to evaluate negatives. These criteria helped reduce test slide costs and made test slides more acceptable to Maryland's regulated cytology laboratories.

The final difficulty we panel members grappled with was how exactly to fund the program. There was no question where the money would generally come from: Maryland's General Assembly decided that the program would be fully self-supported, meaning the regulated cytology labs would have to pay for it. The question was how to spread the cost--estimated at $60,000 per year-among 80 labs that screened slightly more than one million slides per year.

The panel's hospital-based pathologists thought their labs would be unfairly burdened if test fees were based on a count of pathologists in a testing facility because hospitals often have a number of pathology residents and pan-time pathologists. They also felt that for-profit, independent labs were better able to shoulder more of the costs than nonprofit hospitals.

Eventually, a compromise was reached. Proficiency testing fees in Maryland would be assessed on a sliding scale that calls for a base fee of $250 per laboratory plus $50 per cytotechnologist taking the test (the number of pathologists doesn't matter) and 2 cents per gynecologic slide screened in the previous calendar year.

Say a lab with two cytotechnologists screens 40,000 slides per year. It would pay an initial PT fee of $1,150-$250 plus $100 for the cytotechnologists plus $800 for the slide volume. There is also a fee of $50 for each reexamination.

Maryland initiated a pilot cytology PT cycle running from November 1988 through June 1989. This first cycle is an experiment and will be conducted without PT fees, permanent grades, or mandatory retesting or retraining. It will give my division a chance to work out any bugs in the testing methods and gain the cooperation of the cytology labs.

The first formal annual testing cycle begins in October 1989. During the first two yearly cycles, test sets will contain only cervicovaginal slides. Body fluid slides (e.g., cerebrospinal fluid, joint fluids) will be introduced to test sets in October 1991.

Microcomputer software is under development to grade proficiency tests automatically, print out letters reporting test results, and compile statewide statistics on tests.

Maryland's new proficiency testing program for cytology labs is an improved version of existing models because it introduces a standardized diagnostic terminology, an unsatisfactory specimen category, and fairer grading systems for both cytotechnologists and pathologists. We think these improvements should be incorporated into similar programs in other states.

In fact, when Federal regulators create the national cytology PT program called for by the Clinical Laboratory Improvement Amendments of 1988,9 they should consider adopting the Maryland model.

1 Bogdanich, W. Lax aboratories: The Pap smear misses much cervical cancer through labs' errors. Wall Street Journal, Nov. 2, 1987.

2. Thompson, L. Nelson, R.; and Duffy, S. Deadly mistakes. NBC affiliate WRC-TV, Washington, D C., Nov. 16-20, 1987.

3. Senate Labor and Human Resources Committee hearings. Cancer detection in women. Washington, D.C., Jan 28, 1988.

4. Maryland Health Gen Code Ann. 17-201 et seq., 1988.

5. Penner, D. Quality control and quality evaluation in histopathology and cytology. Pathol. Ann. 8:1 19, 1973.

6 Collins, D. , and Patacsi, D Proficiency testing in cytology in New York Analysis of a 14-year state program. Acta Cytol. 30: 633 642, 1986.

7. Mary and Administrative Register 16(1): 94 98, 1 989.

8 Collins, D.; Kauffman, W., and Clinton, W. Quality evaluation of cytology laboratories in New York State Expanded program, 1971 -1973. Acta Cytol. 18: 404 413, 1974.

9. Clinical Laboratory Improvement Amendments of 1988 42 U.S.C. 263a (amended sec, 353), 1988.