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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.
Representative terms from entire chapter:
waste management
