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Health care financing administration receives plenty of comments on laboratory proposals

Article Abstract:

New regulations proposed by the United States Health Care Financing Administration directed at establishing regulations for the licensing of medical laboratories within the United States have been unanimously denounced by the National Committee for Clinical Laboratory Standards. The committee, including over 100 industry representative representing and more than 300 physicians, laboratory directors, and health administrators, sees the new regulations as inefficient and interfering. The Health Care Financing Administration solicited responses to its proposal, and an unprecedented response was received. The document designates three classes of laboratory procedures, depending upon complexity: levels 1 and 2, and waivered. Level 1 procedures can only be done in laboratories that are inspected and tested for proficiency every two years. Level 2 tests are the most complex, and in addition to the standards described for level 1, the laboratories must be under control of either a medically qualified pathologist or doctorate-level scientist. Waivered tests must have a waiver certificate, which requires renewal every two years and is subject to random inspection. The practical ability of the Health Care Financing Administration to supervise 100,000 such laboratories doing level 1 or 2 procedures, and another group of 35,000 office laboratories doing waivered tests is doubtful. The proposed rules could be disastrous for the small, rural hospitals, which under this proposal may be forced to close. Similarly, physicians who provide laboratory services to their patients may be similarly affected. While criticism has been leveled at these proposals, there is a belief by the general public that laboratory practices and test reporting have not been properly handled; current legislation is based on this premise. (Consumer Summary produced by Reliance Medical Information, Inc.)

Author: Marwick, Charles
Publisher: American Medical Association
Publication Name: JAMA, The Journal of the American Medical Association
Subject: Health
ISSN: 0098-7484
Year: 1990
Standards, United States. Centers for Medicare and Medicaid Services

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Information 'leaking' about CLIA-implementing regulations to be published early in 1992

Article Abstract:

The Clinical Laboratory Improvement Amendments of 1988 (CLIA) set guidelines for quality control and certification of clinical laboratories. The new draft of the CLIA is significantly different from the controversial draft that was published in May 1990. The new draft divides laboratory tests into waivered, moderately complex and highly complex tests. Waivered tests are simple to perform and require minimal training. Laboratories that perform waivered tests will not need certification, but the number of waivered tests has been reduced from 17 to six. Complex tests - which often involve multiple steps - require knowledge, training and experience. Laboratories that perform moderately complex and highly complex tests must be certified. They must be directed by a doctor who has experience operating an office laboratory. Employees would be tested for proficiency every four months.

Author: Marwick, Charles
Publisher: American Medical Association
Publication Name: JAMA, The Journal of the American Medical Association
Subject: Health
ISSN: 0098-7484
Year: 1991
Diagnosis, Laboratory, Laboratory diagnosis

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Administration attacks increasing use of marijuana

Article Abstract:

The US government has increased its efforts to convince marijuana users that the drug is bad for their health. Marijuana has been increasing among teenagers since 1992, according to a survey done for the National Institute on Drug Abuse (NIDA). Close to one-third of the high school students questioned said they smoked marijuana in 1994, up from 22% in 1992. Cigarette smoking among teens is increasing in tandem with marijuana use. At a 1995 NIDA meeting, government officials attacked the use of marijuana as dangerous, addictive, and illegal and cited rising marijuana seizures and arrests. Protesters advocating marijuana research and the use of marijuana in medicine complained that their position was not being heard by the government. NIDA has developed the Marijuana Prevention Initiative which, focuses on providing information about the dangers of marijuana use.

Author: Marwick, Charles
Publisher: American Medical Association
Publication Name: JAMA, The Journal of the American Medical Association
Subject: Health
ISSN: 0098-7484
Year: 1995
Usage, Conferences, meetings and seminars, Teenagers, Youth, Drug use, Marijuana, United States. National Institute on Drug Abuse

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Subjects list: Laws, regulations and rules, Medical laboratories, Biomedical laboratories
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