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Rules and Regulations

This page is dedicated to the rules and regulations which affect the lives of clinical laboratorians.  Please note that these links will open in a separate window; to return to this screen, close the open window or click on the appropriate icon at the bottom of the screen.

CDC Case Definitions

Notice to Readers Changes in National Notifiable Diseases Data Presentation.
Morbidity and  Mortality Weekly Report,  June 4, 1999;48(21):447-448. 
Comments:  Lists the 56 infectious diseases that must be reported to state and local health departments.

CLIA '88

CLIA-88 Compliance Lists. Includes lists of laboratories sanctioned by HCFA in 1998 for non-compliance with the Clinical Laboratory Improvement Act.

Notice of Specific List for Categorization of Laboratory Test Systems, Assays, and Examinations by Complexity.Centers for Disease Control and Prevention (CDC), HHS.  [Federal Register: April 11, 1997;62(70):17832-17849]

FDA

Medical Devices; Exemptions From Premarket Notification and Reserved Devices; Class I.   Food and Drug Administration, HHS.  [Federal Register: February 2, 1998;63(21):5387-5393].

Medical Devices; Classification/Reclassification; Restricted Devices; Analyte Specific Reagents.  Final Rule.   Food and Drug Administration, HHS.  [Federal Register: November 21, 1997;62(225):62243-62260]

Guidance for Industry in the Manufacture and Clinical Evaluation of  In Vitro Tests to detect Nucleic Acid Sequences of Human Immunodeficiency Virus Type 1 -DraftGuidance.  Food and Drug Administration, July, 1998. Comment from Stephen Day, Ph.D.:  While very few of us are manufacturers, this guideline also addresses clinical validation of assay performance including preclinical studies and general issues such as determining precision, non-specificity, validation of intended use, etc. and addresses the numbers and types of patient specimens required. 

Hepatitis

Recommendations for follow-up of health-care workers after occupational exposure to hepatitis C virus.  Morbidity and Mortality Weekly Reports 1997 July 4;46(26):603-606. 
Comments: Among other recommendations, the CDC recommends against post-exposure prophylaxis with immune globulin or antiviral agents (e.g., interferon). 

Human Immunodeficiency Virus

Public Health Service Guidelines for the Management of Health-Care Worker Exposure to HIV AND Appendix - First-Line Drugs for HIV Post-Exposure Prophylaxis. 
Morbidity and Mortality Weekly Reports   May 15, 1998;47(RR-7):1-39. 

Public Health Service Task Force Recommendations for the Use of Antiretroviral Drugs in Pregnant Women Infected with HIV-1 for Maternal Health and for Reducing Perinatal HIV-1 Transmission in the United States. Morbidity and Mortality Weekly Reports,  January 30, 1998;47(RR-2):1-39. 

Mycobacterium Tuberculosis

OSHA web site listing sources for occupational exposure to tuberculosis (http://www.osha-slc.gov/SLTC/tuberculosis/index.html).

Occupational Exposure to Tuberculosis.  Proposed Rule.   Occupational Safety and Health Administration (OSHA), Department of Labor.  [Federal Register: October 17, 1997;62(201);54159-54209]

Goals for Working Safely With Mycobacterium Tuberculosis in Clinical, Public Health, and Research Laboratories Notice from the Centers for Diseases Control and Prevention [Federal Register: April 28, 1997;62(81):23065]

Quality Assurance

The New York State Department of Health, Laboratory Quality Assurance Program

Sexually Transmitted Diseases

2002 CDC Guidelines for Treatment of Sexually Transmitted Diseases. 

2002 CDC Guidelines for Screening Tests to Detect C. trachomatis and N. gonorrhoeae