CDC floats uniform proficiency testing plan.

CDC floats uniform proficiency testing plan

Laboratorians are carefully watching the development of a uniform proficiency testing program put forth by the Centers for Disease Control. The program would apply to all labs that receive Medicare reimbursement and those licensed for interstate operations under the Clinical Laboratory Improvement Act.

Although any such program could be a year or more away from impact, CDC is anxious to move ahead, and laboratory groups are paying serious attention. Associations are wary about possible duplication of efforts between the private and public sectors, but some factions feel agreement is the best way to avoid greater intrusion by the Federal Government.

As currently envisioned, the program would assess eight specialty areas through mail-ins of specimen test results. The areas are chemistry, hematology, immunohematology, immunology, bacteriology, mycobacteriology, mycology, and parasitology. Although toxicology and cytology are excluded, an expansion is under consideration.

In preparing the proposal, a CDC task force "tried to develop a program that will assess the quality of those laboratory tests whose results, if in error, carry a moderate to high risk of death or severe injury to the patient, and/or are widely used,' according to a draft document. The degree of use of a test was not given as much consideration as potential patient risk in selecting the specialty areas. Certain analytes and organisms were excluded from the regulatory proposal because it would be hard to produce materials suitable for a national mail-in testing program.

If adopted by the Health Care Financing Administration as a regulatory change, the testing program would establish basic criteria for the quality of lab performance that the agency requires from both Medicare and CLIA laboratories.

CDC has been working on the recently unveiled proposal since leaving the proficiency business last year. Although specific requirements for a proficiency testing program were included in the 1967 CLIA regulations, a description of minimum Government standards has never been provided. "As a consequence,' according to a CDC official, "states have offered or approved proficiency testing programs that vary considerably in their degree of challenge.'

All samples distributed to participating labs would replicate actual patient specimens whenever possible. CDC recognizes that the sample production and distribution process should be subject to rigorous quality control, so that samples are homogeneous and stable within the appropriate time frame. The homogeneity of the samples could emerge as a vital issue, given CDC's plan for a uniform grading system.

For each specialty area, CDC has spelled out program content and frequency of challenge, evaluation of test performance (and analyte where appropriate), and criteria for acceptable performance.

In the areas of chemistry and hematology, for example, an approved program would provide a minimum of two samples every three months. Over the course of a year, the program would provide samples covering the range of values that would be expected in patient specimens. The minimum number of challenges per quarter for each analyte or test is listed in the CDC draft proposal.

Evaluation of analyte or test responses in chemistry and hematology would be based on the accuracy of the responses. The grading system is rather involved, but, once more using chemistry and hematology as examples, it goes like this:

For qualitative tests or analytes, the "correct' response for each challenge would be determined by 80 per cent or greater agreement among at least 10 reference laboratories.

For quantitative tests or analytes, the correct response would be determined by the distance of the response from the target value. The target value would be the mean of all responses after removal of those measuring more than 3 standard deviations from the original average, or the average of groups of 20 or more labs using the same methodology (the latter would apply only when the method bias skews the distribution of responses).

After the target value is established, the appropriateness of each response would be assessed, using either fixed criteria or the number of standard deviations from the target value. CDC has outlined an evaluation scheme for each response by analyte or test.

"Acceptable' overall performance would be defined this way for chemistry and hematology: For the two most recent testing events, a laboratory must not have any test or analyte for which the individual results have been unacceptable, and the lab must maintain an overall average score of 80 per cent of acceptable responses for any recognized reimbursement or licensure category. Failure to participate in a survey, except where a lab does no patient specimen testing in a particular proficiency category, would result in a score of zero for that survey.

The first public hearings on the proposal were held in early May at CDC headquarters in Atlanta. Attending were representatives from the College of American Pathologists, the American Association of Bioanalysts, the American Association for Clinical Chemistry, and the American Society for Internal Medicine.

The last group was on hand for a preemptive strike against possible application of the program to physician office labs. The proposal is clearly not aimed at covering doctors' labs, but ASIM may push for some explicit regulatory language to that effect. At press time, an AACC spokesperson said the group may submit formal comments to CDC, but noted that any proposed changes would be mainly technical rather than substantive.

Much of the Atlanta meeting was devoted to a discussion among officials from CDC, HCFA, AAB, and CAP--the latter two being the lab professional groups most involved with proficiency testing.

Just after the meeting, Nicholas Serafy Jr., associate director of AAB's Proficiency Testing Service, said the CDC position "seems to be a reversal of their policy not to overburden the laboratories.' He also commented that the CDC proposals are, in many cases, less stringent than private sector guidelines currently in place.

Noting similarities between the CAP and AAB guidelines, Serafy stated, "The easy way to go about it might be to say, "These two programs aren't that far apart, let's see if we can get them to agree on certain points.'' That intermingling would, of course, depend upon "political' matters between the two private groups. For its part, CDC appears intent on trying to reconcile standards in a way that will best meet the public interest.

AAB's Serafy added that CDC has proposed different grading criteria from those currently in place in the private sector, and that a change would require laboratories to increase their investment in time and other resources.

Copies of the CDC proposal are available from the Division of Assessment and Management Consultation, Training and Laboratory Program Office, Centers for Disease Control, Atlanta, Ga. 30333; [phone].

Office lab rules still at HCFA

The Health Care Financing Administration missed an April 1 deadline for submission of a report to Congress on possible standards to be enacted for physician office laboratories.

At this writing, several hundred pages of text had been finished by the original authors, but they were still making the agency rounds for corrections and approval. No timetable for completion of the process was available, and there are no signs that key Congressmen are clamoring for the results.

Also percolating its way through the bureaucracy: The "deemed status' requested by CAP for its lab review program under Medicare. At press time, CAP officials were still hoping for the okay sign, but HCFA sources indicated that only time would tell--how much time, no one could predict.

On Capitol Hill, it further appears as though the much-discussed inclusion of radiologists, anesthesiologists, and pathologists (RAPs) in DRG rates is in political hot water. Under intense lobbying pressure from the American Medical Association, law-makers are considering a resolution that could label the prospective payment extension dead on arrival in Congress.