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AACC issues guidelines on drug abuse, cholesterol testing.

AACC issues guidelines on drug abuse, cholesterol testing

The American Association for Clinical Chemistry landed a solid punch in the fight against durg abuse by announcing a comprehensive set of guidelines for selecting and monitoring drug testing laboratories.

At its annual meeting in San Francisco in July, AACC also took aim at another well-known killer with a separate set of provisions about cholesterol testing.

Both packages of recommendations are being viewed as significant achievements, although drug abuse testing has received the most attention lately in Washington, as well as in the media.

It was one year ago this month that President Reagan signed an executive order calling for drug testing of Federal employees. The Health and Human Services Department was charged with developing technical guidelines for the testing, along with certification standards for contracted laboratories. At press time, it was expected that the HHS guidelines would be released by mid-August. They would then be subject to a public comment period and revision before President Reagan's order could be further implemented.

Meanwhile, attention continues to focus on the problem of false positive in drug screening programs; that is, tests that indicate illegal drug use when, in fact, the individual has not used such substances.

Researchers for the College of American Pathologists estimate that 34 per cent of court cases questioning the accuracy of drug testing show that the methods are not legally defensible (usually because a lab uses a single test method instead of confirming by a second, different procedure). CAP announced it will next month begin a new program for accrediting drug testing laboratories.

CAP spokesman Thorne Butler, M.D., said, "These are not going to be easy surveys and inspections to pass; the demands on the laboratory are very stringent. If a laboratory has a false positive, its accreditation may be withdrawn until we resolve the question of how it happened.'

The AACC guidelines contain advice for companies and organizations on how to check the experience of laboratories and the credentials of key personnel, as well as how to set requirements for quality control measures. Also provided are recommendations on "chain of custody' requirements, reporting security procedures, specimen storage, and policies on contested results. Specifically, organizations should:

1. Require that lab testing methodologies meet specific testing needs. Analytical methods available for screening and confirmation testing should be appropriate for the intended use. In particular, the lab should be able to provide sophisticated testing methods, such as gas chromatography /mass spectrometry for confirmation, if needed.

2. Correctly target drugs, threshold levels, and methods of screening. Drugs to be included in the screen(s) and the threshold levels for each should be specified. The specification should be based on geographic area, drugs most likely to be encountered, and on the group being tested.

3. Verify the lab's drug testing experience. The laboratory should have a verifiable record of conducting drug testing and have personnel experienced in drug testing operations.

4. Review the credentials of key lab personnel (scientific director, certifying scientist, and/or supervisor). Tests should be conducted by certified clinical chemists or toxicologists, or technologists supervised by these professionals. Prompt written notice of any key staff changes should be required.

5. Require quality assurance measures. The lab should be involved in an external quality assurance program. It should be enrolled in at least one independently administered proficiency testing program to measure its ability to accurately detect drugs in specimens sent to it. Proficiency testing reports should be reviewed to evaluate performance, including accuracy rating and the number of false positives and false negatives for each drug in the sample.

6. Review "chain of custody' procedures. The lab should be able to provide a secure method of documenting how specimens are handled, and by whom, as they proceed through the testing process. Specimens should be properly collected, identified, and labeled, and delivered promptly. Each person handling the specimen must sign the form accompanying the specimen. Even though a specimen has been accurately analyzed, test results may be questioned in legal proceedings without a chain of custody.

7. Require advance written notice of changes in methods or thresholds. The lab should identify how any such canges may affect results or interpretations.

8. Evaluate lab reporting security procedures. To insure confidentiality, the lab's security system and procedures for reporting test results should be investigated. A coded number system should identify specimens, and a secure system for obtaining results by telephone should be designed.

9. Require timely reporting of results. The turnaround times should be written into the agreement or contract with the lab.

10. Review specimen storage procedures. After analysis, positive specimens should be stored frozen and the chain of custody maintained for a length of time specified in the contract or agreement. Legal counsel should be consulted to determine the length of time for specimen storage and record maintenance. Christopher S. Frings, Ph.D., a toxicology expert who helped develop the AACC guidelines, recommends positive specimens be kept for at least six months and negative specimens for at least one week.

11. Review the policy on contested test results. The lab should offer expert technical testimony during hearings, arbitration, or court-related cases.

12. Check lab licensing and accreditation. The lab should meet any Federal, state and/or local licensing requirements and participate in a professional quality assurance program.

13. Continue to monitor the quality of the testing program. Each of the lab's proficiency testing reports and other daily quality assurance results should be reviewed regularly.

14. Require a complete description of all lab fees and charges in advance. Determine the exact cost of the testing and what is to be included in the fee. If chain of custody, confirmatory tests, consultation, and supplies (specimen containers, tamper-proof tape, labels, etc.) are not included in the fee, the price of these services should be included in the letter of agreement or written contract.

The AACC guidelines have been well received by the lab industry, according to Dr. Frings. "I think our main emphasis now is on getting them out to the companies that have or are considering testing programs. Many of them don't have the expertise to select a qualified laboratory, and some simply go with the cheapest one available.' Frings expects that, through interaction among professional groups and the Federal Government, a mutually agreeable set of guidelines will be available by Jan. 1.

The AACC also has high hopes for the potential contribution of its four position statements on cholesterol testing. Outlined, they are as follows:

AACC calls for a national educational program on advances in cholesterol health standards and testing to help reduce the prevalence of elevated blood cholesterol in the U.S.

AACC encourages accurate, efficient cholesterol measurement through use of the National Committee for Clinical Laboratory Standards' national reference system, which covers reference materials and method.

AACC recommends that mass screening programs for high levels of blood cholesterol be integrated with established community health activities and with accredited clinical laboratories. In all screening programs, elevated cholesterol values should be confirmed by repeat testing in an accredited lab.

AACC recommends that cholesterol screening conducted in non-laboratory settings follow certain principles of laboratory management and quality assurance to obtain reliable measurements.

The last statement is important as more testing moves to nontraditional test sites such as physicians' offices. A problem noted by the position statement is that most personnel at such sites "lack experience with the extensive quality assurance programs employed in clinical laboratories.'

AACC cholesterol committee chairman Herbert K. Naito, Ph.D, said the position statements should help fight America's leading cause of death--coronary heart disease. "Identifying people with high cholesterol is a vital public health service,' he comments, "but expanded efforts to do so will place major new demands on the resources of screening facilities and clinical laboratories. The positions were developed to provide direction for meeting these demands in the most effective and professional manner.'
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Title Annotation:American Association for Clinical Chemistry
Publication:Medical Laboratory Observer
Date:Sep 1, 1987
Words:1316
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