Testing controversy highlights CLIAC's June gathering.

A special session of the Clinical Laboratory Improvement Advisory Committee (CLIAC) on June 20-21, 2006, addressed updating proficiency testing (PT) for gynecologic cytology methods. The agenda included a Center for Medicare and Medicaid Services' (CMS') update; overviews of gynecologic cytology laboratory practice and methods as well as cervix cancer; information on recent cytology-testing advances; a cytology PT data summary; and a Cytology PT Workgroup report.

CMS update

Judy Yost, director, Division Laboratory Services, Center for Medicaid and State Operations, CMS, explained why the Senate halted committee discussions of a bill (similar to the House-passed HR 4568) that would suspend CLIA's PT requirement for those personnel performing gynecologic cytology testing to enroll in a CMS-approved PT program until such time as CLIA had implemented changes to its PT requirements. If discussions resume on Capitol Hill, it is generally believed that the debate will be more balanced with the inclusion of CLIAC recommendations regarding improvements to the gynecologic cytology PT program, which were finalized at this June session.

Testing successes and failures

Data regarding the 2005 cytology PT program was presented from the State of Maryland and Midwest Institute of Medical Education (MIME), which is now owned by the American Society of Clinical Pathologists. In this program, individuals are categorized as cytologists, primary MD, secondary MD, or locum tenens. The initial testing event (10 slides in two hours) revealed the following: Of the 12,826 total, 11,649 (91%) passed, and 1,177 (9%) failed. The highest category of individuals to fail was the primary MD.

George G. Birdsong, MD, Emory University School of Medicine, and former CLIAC member, presented on the advancements in cytology-testing technology; he believes a four- to five-year lag exists before enough slides will be in the marketplace to adequately perform PT. George K. Nagy, MD, from the Cytopathology Section of the Wadsworth Center's Laboratory Programs at the New York State Department of Health, using statistical analyses, presented on the limitations of the 10-slide cytology PT method, pointing out the high probability that many scores are misclassified due to the small number of testing-pool slides.

The grading debate

At this session, as in past meetings, most CLIAC members wanted to discuss changing CLIA from grading an individual to grading the laboratory. According to officials of the Center for Disease Control and Preventions, this issue is not debatable because CLIA law states the individual--not the laboratory--must be enrolled in a PT program. Members were reminded that CLIAC is an advisory committee to the group that writes the rules that fall under the law, not the advisory committee to Congress, which writes the law.

CLIAC agreed upon the following recommendations:

* use its preamble to encourage labs to participate in educational lab programs, in addition to individual PT;

* oversight organizations, agencies, and surveyors to make labs aware of resources for participation in educational programs;

* change current language from "slides" to "challenges" to allow for the use of virtual slides;

* define a challenge as a case equivalent--glass slide, virtual slide, or other approved media;

* add requirement for a transition phase for all new technology (virtual slides) during which an individual can request retesting with a previous platform format (e.g., glass slides);

* reduce the frequency of testing to a three-year test cycle using 20 challenges for every test (initial and retest), with the 20 challenges being reviewed within four hours;

* retain four categories and continue to require at least one challenge from each;

* recommendations for PT vendors:

* require biopsy confirmation of Category D (HSIL/cancer) challenges but not Category C (LSIL) challenges;

* require field validation, monitor challenges continuously, and remove challenges that fail field validation;

* require validation procedures to be disclosed by the PT vendor;

* provide educational feedback on discrepancies for pass or fail;

* PT provider can determine alternate options for test sites for missed tests (i.e., excused absences) and retesting--the preamble could be used to encourage more options for test sites;

* PT provider can determines the proctor requirements; and

* require PT providers to disclose the appeal process in writing.

* change language to "individuals who score less than 90% must ..." as opposed to "individuals who fail;" and

* change grading scheme to Unified Model X (Note: two members voted against Model X).

CMS' Yost presented a typical timetable for finalizing any CLIA changes, emphasizing the number of government entities that have to "bless a document before it is published for public comment." When all comments are received and the changes are finalized, the three-year testing cycle could possibly be implemented as early as 2008, a relatively early date.

Controversy surrounds Model X

The most controversial issue during this session was the scoring grid. It has been recommended that the current grids, Models A and B, which are used to determine pass and fail PT scores, should be changed to Model X (see Figures 1 and 2). It is argued that Model X "levels the playing field" for physicians and cytotechnologists. Currently, physicians must be able to differentiate between low- and high-grade cell abnormalities. In the Model X recommendation, the grading scheme would not count against a physician's score if he does not differentiate between the abnormalities. Because the adoption of Model X might have the appearance of being self-serving in reducing the number of failures by physicians due to the less-stringent grading criteria recommended by CLIAC, consumer watchdogs may criticize such a change. Comments from some CLIAC members indicated that this change appeared to be contrary to the origin of CLIA '88, which was in response to poor quality PAP testing.

[ILLUSTRATION OMITTED]

Figure 1. MODELS A and B--Low-grade squamous intraepithelial lesion
(LSIL); high-grade squamous intraepithelial lesion (HSIL)

MODEL A
Correct    Current Grid - 10-Slide Test, based on a 100-point system
Response?

            Examine Response - Pathologist (Technical Supervisor)

            A - UNSAT    B - NEGATIVE          C - LSIL      D - HSIL

A - UNSAT   10           0                     0             0

B -         5            10                    0             0
NEGATIVE

C - LSIL    5            0                     10            5

D - HSIL    0            -5                    5             10

MODEL B
Correct     Current Grid - 10-Slide Test, based on a 100-point system
Response ?

            Examine Response - Cytotechnologist

            A - UNSAT    B - NEGATIVE          C - LSIL      D - HSIL

A - UNSAT   10           0                     5             5

B -         5            10                    5             5
NEGATIVE

C - LSIL    5            0                     10            10

D - HSIL    0            -5                    10            10

Figure 2. MODEL X--Low-grade squamous intraepithelial lesion (LSIL);
high-grade squamous intraepithelial lesion (HSIL)

MODEL X
Correct   20-Slide Test, based on a 100-point system
Response

                  Examine Response - Cytotechnologist and MD

                  A - UNSAT   B - NEGATIVE  C - LSIL  D - HSIL

A - UNSAT         5           0             0         0

B - NEGATIVE      2.5         5             0         0

C - LSIL          0           0             5         5

D - HSIL          0           -5            5         5

By C. Anne Pontius, MBA, CMPE, MT(ASCP)

C. Anne Pontius, MBA, CMPE, MT(ASCP), is president of Laboratory Compliance Consultants in Raleigh, NC.