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Panel gives recommendations on Pap, HIV, cholesterol, drug abuse testing.

In a move that illustrates the lab community's concem about problem areas, a panel of medical testing experts recently recommended more than 20 ways to improve performance and better address patient needs.

The panel was assembled in late October at the National Institute of Standards and Technology (formerly the National Bureau of Standards) by a coalition of 14 professional, industry, and Federal organizations representing nearly every facet of the lab testing and medical communities. After two days of intensive review in working groups, experts filed their recommendations on Pap smears, HIV testing, cholesterol testing, and testing for drug abuse in the workplace.

The recommendations were presented at a well-attended press conference on the final day of the meeting. They have been submitted to the National Committee for Clinical Laboratory Standards (NCCLS), which will use its consensus process to seek broader agreement and voluntary compliance. The following is a summary of the findings by individual areas examined: * Pap smears. Despite widespread reports on problems with Pap smears, the cancer screening technique "truly remains a woman's best tend," according to presenter Beverly B. Kraemer, M.D., director of cytopathology at St. John's Medical Center, St. Louis.

Allowing that the procedure is "not perfect," Dr. Kraemer announced four major recommendations for pre-analytical phases:

A national education effort should be initiated to improve the overall specimen quality for Pap smears. The effort should be directed toward those personnel involved in specimen acquisition.

$Educational efforts must also be undertaken to insure that patients are optimally prepared for their Pap test and are informed about the process involved in examination of the Pap smear.

Specimen adequacy: The cervix must be properly visualized, and both the endocervix and ectocervix should be thoroughly sampled . Inadequate specimens must be documented, and requests for repeat smears should be verified. The specimen must be well fixed, appropriately labeled, and all pertinent clinical information should be available.

$Regarding technique evaluation: The panel endorses NCCLS's goal of standardizing all aspects involved in acquisition of a Pap smear. Experts are "highly optimistic" that will improve overall quality.

As for intra- and post-analytical phases, Dr. Kraemer noted, "It took the pathology community 40 years to develop state-of-the-art proficiency testing programs for the clinical lab; with the legislative mandate before us [see news report at end of column], we have only a short time to do the same for cytopathology."

The panel strongly suggested that state and Federal efforts immediately address the crisis of manpower shortages in cytotechnology; basic research in present technological assessment; optimal workloads; and evaluation of evolving technologies for diagnostic cytopathology. The group further recommended that gynecologic pathology be better reimbursed to reflect the true costs associated with those services.

*HIV testing. Among the findings presented by Thomas O'Brien, Ph.D., manager of technical support for AIDS testing with the Du Pont Company:

1. The combination of screening procedures and a standardized Western blot confirmation test gives a conclusive diagnosis in virtually all infected individuals. All labs should use the ELISA and Westem blot sequence for HIV testing.

2. An individual should not be informed that he/she is infected until confirmatory testing is completed.

3 . Additional different confirmatory assays should be used to clarify the status of any indeterminate results in an effort to report final results as positive or negative.

4. For quality assurance, HIV reference materials should be made available and used routinely to determine testing accuracy in routine lab practice. Proficiency testing should be mandatory for all labs performing HIV tests.

5. Worker safety should be stressed by developing legal guidelines on the rights of an individual following a needlestick injury with a specimen whose HIV status is unknown.

6. Health professionals and paraprofessionals should complete an educational course on the transmission, control, treatment, and prevention of HIV infection and AIDS, with emphasis on appropriate behavior and attitude change.

7. HIV infection should be viewed in its totality as a communicable disease subject to public health measures such as reporting. The success of such reporting depends on strict confidentiality of test results. Such reporting systems are currently in place in 13 states.

* Drug testing. Testing for drugs of abuse (e.g., marijuana, cocaine, amphetamines, PCP, and heroin) was strictly differentiated from testing in a medical environment such as the hospital emergency room.

Among the key recommendations, Navy Commander David Von Minden of the Armed Forces Institute of Pathology reported: "Since the use of a common reference material can further enhance the capabilities of today's workplace substance abuse testing programs, the development of additional reference materials should be undertaken."

And, Von Minden said, "Since the level of impairment cannot be correlated with urine drug concentration, we recommend that additional research be conducted to correlate drug concentration in body fluids with the level of impairment."

The drug testing group felt that a supportable workplace drug abuse program requires a policy statement understood by all employees. Elements should include reasons for implementation, identification of individuals to be tested, identification of substances tested for, and actions pending positive results. Employers should also specify retesting policy, utilization of certified labs, appeal mechanisms, actions against those who refuse testing, availability of rehabilitation, and record confidentiality.

In the case of pre-employment testing, the applicant should be informed that a urine test is part of the evaluation. The applicant should be informed of the test results.

*Cholesterol testing. Authorities commented at the outset that state-of-the-art cholesterol testing by hospitals and independent labs is better than is generally understood by the public. Still, as described by Gordon Edwards, Ph.D., a Miami-based consultant, their recommendations for improvement were:

1. The accuracy of cholesterol measurements done in physicians' office laboratories should be studied since POLs generally do not participate in proficiency testing programs. The panel advised that PT be required for cholesterols in physician labs under recently enacted law (see below).

2. Lab scientists and equipment manufacturers should identify differences in synthetic serum fluids and fresh human serum used to evaluate lab performance.

3. NCCLS should initiate development of a reference system for other tests related to heart disease risk.

4. A system for achieving even greater accuracy should be developed in accordance with recommended National Reference Systems for Cholesterol consensus guidelines, including traceability to the NRS/CHOL reference method for possible new reference materials.

5. Historical information on the performance of a particular test system for measuring cholesterol in fresh serum compared with other fluids (e.g., PT samples) should be provided to lab users.

6. The National Cholesterol Education Program Coordinating Committee of the National Institutes of Health should include a representative of the lab community . It currently does not.

Lab bill enacted

After months of proposals and counterproposals in Congress, President Reagan signed legisiation sealing the most sweeping overhaul of lab regulation in more than 20 years.

Effective Jan. 1, 1990, the Clinical Laboratory Improvement Amendments (CLIA) of 1988 will require that all labs-including POLs-be Government-certified and adhere to proficiency testing standards. Personnel and inspection standards will also apply, although POLs and intrastate labs will have until July 1, 1991, to comply.

Certification will be waived for lab sites performing only low-risk testing, as defined by regulators. There is no "deemed status" spelled out for PT, although lawmakers clearly do not intend to put the Federal Government back into that business.

At the llth hour, lawmakers agreed to delete two controversial CLIA provisions that would have required direct billing for lab tests and prohibited doctors from referring tests to labs in which they have a financial interest.
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Publication:Medical Laboratory Observer
Date:Dec 1, 1988
Previous Article:Will unions solve the lab staffing problem?
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