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Appendix G Regulation and Accreditation REGULATORY DEFINITIONS Accreditation A voluntary process recognized as a measure of quality. It is used by some regulatory agencies as one criterion for granting certification and licensure. Standards for accreditation may be similar or identi- cal to standards for licensure. Accrediting organiza- tions are usually based on peer approval, voluntary quality control, education, and consultation. Licensure The process by which an agency or government grants permission to persons or facilities meeting predetermined qualifications, to engage in a given occupation, use a particular title, or perform speci- fied functions. Certification The process by which a nongovemment agency or association grants recognition to a person who has met certain predetermined qualifications specified by that agency or association. Equivalency or Reciprocity A mechanism for comparing programs and func- tions so that one may be used in lieu of the other. Often the legal body (e.g., a federal agency) main tains authority and stringency over standards even when another organization is identified as an accept- able or equivalent alternative authority. Guideline Suggested operating practice or procedure often broadly written. Use of a guideline may be voluntary and is often established by the private sector to self- govern its activities. When issued by a federal agency, strict adherence to the guideline is not obligatory. However, federal guidelines specify one manner of satisfying legal requirements that will be accepted by the agency for the purpose of establishing compli- ance. Inspections Careful, critical, on-the-scene examinations that determine violations against an accepted or legal stan- dard. Inspections may be for accreditation, licen- sure, certification, or safety. Depending on the in- spection type, it may or may not be announced ahead of time. Law or Act A legal requirement established by legislative and executive authority, often written in broad, gen- eral language. An agency designated by the law must establish or promulgate the specific regulations in order to define how the act will be implemented. NOTE: Regulatory definitions are modified from Rose, S.L 1984. A Regulatory Overview. P. 4 in Clinical laboratory Safety. Philadelphia, Pa.: J.B. Iippincou Co. 208
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APPENDIX C Regulation The specific details by which a law is to be implemented. Regulations established by federal agencies are published in the Federal Register. Ini- tially these documents appear as proposals so that interested or affected individuals and groups have the opportunity to comment and participate in the rule-making process. After the comments have been reviewed, and either accepted or rejected, the regula- tion is published again in the Federal Register as the "final rule," and the effective date of implementation . - IS glVen. Standards Specific criteria, to be used unmodified for ma- terials, methods, or practices. Use of a standard may be voluntary or mandatory. If it is put forth by a voluntary-consensus standard-setting group, it is usually voluntary; if promulgated by a government agency, it is mandatory. Regulations issued under federal laws are compiled annually into the Code of Federal Regulations (CFR) and arranged by subject into assigned Titles: e.g., Title 9, Animals and Ani- mal Products; Title 10, Energy; Title 21, Food and Drugs; Title 29, Labor; Title 39, Postal Service; Title 40, Protection of the Environment; Title 42, Public Health; and Title 49, Transportation. REGULATORY AGENCIES 1. Federal Agencies a. Occupational Health and Safety Administra- tion (OSHA) The Occupational Safety and Health Act of 1970 created OSHA within the Department of Labor. All biomedical laboratories, and their employees, may be subject to the act. Although federal, state, and municipal laboratories were not specifically men- tioned in the act, Executive Order 12196 (1980) made all federal agencies subject to the same requirements. The purpose of the act was to reduce occupational injuries and illnesses and each employer is required to furnish to each of his employees a job and a work environment that is free from recognized hazards that are causing, or are likely to cause, death or serious physical harm. 209 The relevant sections of the Health and Safety Standards (29 Cow Part 1910) are found within the General Industry Standards. Employers of 11 or more employees must maintain records of all injuries and illnesses as they occur. On-thejob accidents resulting in an employee's death or the hospitaliza- tion of five or more employees must be reported to the nearest OSHA office within 4X hours. Another relevant section is the Hazard Communication Stan- dard (the "Right-to-Know" ruled, which was revised recently to cover all employees exposed to hazardous chemicals, including those working in university re- search laboratories. OSHA has documented its interest in the control of biological hazards by publishing an advanced no- tice of proposed rulemaking concerned with "Occu- pational Exposure to Hepatitis B Virus and Human Immunodeficiency Virus" (52 F-R 4543S, November 27, 1987~. Laboratories covered by the act are subject to inspection by OSHA compliance officers and health officers. b. National Institute for Occupational Safety and Health (NIOSH) NIOSH was also created by the Occupational Safety and Health Act of 1970, but was made a component of the Centers for Disease Control within the Public Health Service of the Department of Health and Human Services. NIOSH does not regulate, issue, or enforce safety and health regulations. It has the responsibility to undertake research to eliminate on-thejob hazards to health and safety. When re- quested by employers or employees, health-hazard evaluations of workplaces are carried out. c. Environmental Protection Agency (EPA) The Resource Conservation and Recovery Act of 1976, as amended, requires EPA to develop and evaluate environmentally sound methods for man- agement of hazardous waste, including infectious waste. In May 1986, the EPA published its Guidefor Infectious Waste Management (National Technical Information Service Publication No. PB86-199130, Springfield, VA 22161~. This documentisintended to provide guidance to persons responsible for infec- tious waste management at hospitals, medical laboratories, research laboratories, commercial diag- nostic laboratories, animal experimentation units,
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210 industrial plants and laboratories, and other facilities that generate infectious waste, such as biotechnology companies. Its appendix contains a tabulation of the state regulations pertaining to infectious waste man- agement, including a summary of the requirements and the identity of the responsible state agency. d. Food and Drug Administration ADA) The FDA issues regulations pertaining to the safety, efficacy, and labeling of drugs and medical devices, including diagnostic reagents and labora- tory equipment, under the provisions of the Food, Drug, and Cosmetic Act, as amended, and of biologi- cal products under the provisions of the Public Health Service Act. The Office of Medical Devices in the Center for Devices and Radiological Health (CDRH) has the responsibility for laboratory instruments, di- agnostic agents, and reagents. The Center for Drug Evaluation and Research (CDER) is responsible for the premarket testing and approval of drug products for human use, and the Center for Biologics Evalu- ation and Research (CBER) similarly controls bio- logical products for human use, including blood and blood products, bacterial and virus vaccines, and cer- tain diagnostic materials for dermal tests and labora- tory tests. The regulations do not directly address issues of safety in biomedical laboratories. These matters are affected indirectly in the regulations cov- ering Current Good Manufacturing Practices (21 Cod, Part 211) and Good Laboratory Practice for Non- clinical Laboratory Studies (21 CFR, Part 58), which apply to laboratories working with infectious materi- als in the course of research, development, testing, and manufacture of controlled products. e. National Institutes of Health (NIH) The National Cancer Institute issues guidelines for the control of contamination in facilities working with cancer viruses. In conjunction with the Centers for Disease Control, the NIH published guidelines for Biosafety in Microbiological and Biomedical Laboratories, which has been reproduced as Appen- dix A in this publication. In addition the NIH pub- lishes guidelines on various other aspects of labora- tory safety, as well as on laboratory animal care. The NIH Guidelines for Research Involving Recorrbi- nani DNA Molecules were first published in 1976. They are updated periodically, most recently in 1986. ArpENDlx G f. Centers for Disease Control (CDC) The CDC has the responsibility for controlling the interstate shipment of etiologic agents under the Public Health Service OHS) Interstate Quarantine regulation (42 CAR, Section 72.25~. The importation into the United States of etiologic agents and vectors of human disease, and subsequent transfer to other laboratories, requires the issuance of a permit to the recipient by the CDC under the provisions of the PHS Foreign Quarantine regulation (42 CF~, Part 71, Section 71.156~. In addition to the CDC/NIH biosafety guidelines mentioned above, CDC pub- lishes recommendations for various other aspects of laboratory safety and operations. g. U.S. Department of Transportation IDOL In addition to the CDC, the DOT has responsi- bility for regulating shipment of etiologic agents, diagnostic specimens, and biological products that _ are shipped in the United States. Its regulation dif- fers in part from the CDC requirements in that pack- aging materials must have been proven to be ade- quate to contain infectious material under a variety of environmental and test conditions, and control is exerted over both intrastate and interstate shipments. h. U.S. Department of Agriculture (USDA) The importation of etiologic agents of plant and animal diseases, serum specimens, and other materi- als of animal origin requires a permit that must be obtained from the appropriate authorities in the USDA. (See Chapter 3, Section G.) i. U.S. Postal Service (USPS) The USPS requirements for the mailing of "dis- eased tissues, blood, serum, and cultures of patho- genic microorganisms" are essentially the same as those of the CDC and DOT. j. U.S. Nuclear Regulatory Commission (IJ.S. NRC) The U.S. NRC strictly regulates the possession, use, and disposal of radioactive materials under a licensing system. 1
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APPENDIX G k. Health Care Financing Administration (HCFA) By overseeing both Medicare and Medicaid pro- grams and related medical care quality control, the HCFA has a direct relationship with hospital labora- tory services and indirectly influences safety con- cems. HCFA currently has the responsibility for licensing and inspecting clinical laboratories, which are subject to the Clinical Laboratory Improvement Act of 1967. 1. Office of Science and Technology Policy (OSTP) The Coordinated Framework for Regulation of Biotechnology: Announcement of Policy and Notice for Public Comment (1986) describes federal regula- tory policy for ensuring the safety of biotechnology research and products. This document emphasizes mostly technologies for emerging genetic manipula- tion, such as recombinant DNA, and summarizes previously published policies of FDA, EPA, USDA, OSHA, and NIH. 2. State and Local Government Regulations States vary in their regulations applicable to bi- omedical laboratories and the handling of biohaz- ardous waste. One summary of state laws regarding hazardous waste is found in the appendix of the Environmental Protection Agency (EPA) Guide for Infectious Waste Management (1986~. This publica- tion can be obtained from the Superintendent of Documents, U.S. Government Printing Office, Wash- ington, DC 20402-9325. III. ACCREDITING BODES 1. College of American Pathologists (CAP) The College of American Pathologists offers a voluntary accreditation program for clinical labora- tories. The requirements for safe work practices include biosafety. The inspector, a practicing pa 211 thologist, completes an extensive checklist during a site review of the procedures and facilities. Cited deficiencies must be corrected before accreditation is granted. CAP accreditation can exempt a laboratory from federal inspection for interstate licensure and is recognized by the Joint Commission on Accredita- tion of Healthcare Organizations. 2. Joint Commission on Accreditation of Healthcare Organizations pCAHO) The Joint Commission on Accreditation of Healthcare Organizations has a number of safety requirements similar to those of the CAP cited above. In addition, it has extensive safety requirements for other areas of the hospital. 3. American Association for accreditation of Labo- ratory Animal Care (AAALAC) One of the considerations for certification by the Council of Accreditation of AAALAC is indirectly related to control of biohazards encountered during the course of experiments involving laboratory ani- mals. The certification process involves an exten- sive on-site inspection, and recertification is a bien- nial event. Recognition by AAALAC attests that the recipient of accreditation is in compliance with the Laboratory Animal Welfare Regulations (9 CF~, Subchapter A, Parts 1, 2, and 3) and adheres to the standards set forth in the Guide for the Care and Use of Laboratory Animals, DHHS Publication No. (NIH) 86-23 (revised 1985~. Both of these publications can be obtained from the Superintendent of Documents, U.S. Government Printing Office, Washington, DC 20402-9325. 4. State Health Departments Health departments of various states are required to perform inspections of medical laboratories that receive payment from Medicaid. They have safety requirements similar to those of CAP and JCAHO cited above. Medicaid and the state health depart- ments will look for safety deficiencies similar to those described for the JCAHO and CAP programs.