(b) Enforces CFR standards to ensure safe work practices in laboratories
and blood centers.
(c) Mandates adherence to current good manufacturing practices (cGMPs)
in blood centers.
(2) Health and Human Services (HHS) Clinical Laboratory Improvement Act
(3) Occupational Safety and Health Administration (OSHA).
(4) Centers for Disease Control (CDC).
(5) Environmental Protection Agency (EPA).
(6) Department of Transportation (DOT).
(7) Nuclear Regulatory Commission (NRC).
d. Voluntary agencies.
(1) Joint Commission on Accreditation of Healthcare Organizations (JCAHO).
(2) College of American Pathologists (CAP).
(3) National Committee on Clinical Laboratory Standards (NCCLS).
e. To meet federal and civilian regulatory and accrediting agency safety
requirements, every medical laboratory should develop a comprehensive safety
program that includes the following:
(1) Clean, well-lit, ventilated facilities with appropriate safety equipment for the
level of complexity of testing.
(2) Written safety procedures that are followed by the staff and enforced by
(3) Identification of staff at risk and development of programs to educate and
train those persons prior to exposure.
(4) A surveillance program that addresses confidentiality issues, which includes
reporting, investigating, and documenting lab incidents and counseling of exposed