REGULATORY - U.S.

clinical laboratories are governed by the laws and

regulatory guidelines of the following federal and state agencies and programs.
• Centers for Medicare & Medicaid Services (CMS): Within the DHHS, regulates
all laboratory testing (except research) performed on humans in the United States
through the Clinical Laboratory Improvement Amendments (CLIA)
• CLIA Program: Program administered through the federal and state agencies to
ensure high-quality laboratory testing
• CLIA 88: Law established by the U.S. Congress to create uniform federal
standards for regulating clinical laboratories; also extended government oversight to
all testing facilities, including physician office laboratories. The government
agencies responsible for overseeing the laboratory standards are CMS, Centers for
Disease Control and Prevention, and Food and Drug Administration
• Family Medical Leave Act (FMLA): Supplies any employee who has
been on the job for over 1 year up to 12 weeks of unpaid, job-protected
leave each year
• Fair Labor Standards Act (FLSA): In 1938 it set guidelines on pay
practices in government, businesses, and health care and defined
overtime pay practices. The Equal Pay Act of 1963 is a section of the
FLSA that affirms equal pay for equal work • Food and Drug
Administration (FDA): Government agency that regulates clinical
laboratories through approval of laboratory test kits and medical devices
and provides clarification on how workload should be calculated when
using current FDA-approved semi automated gynecologic cytology
screening devices
• Centers for Disease Control and Prevention (CDC):
Government laboratory working on the Battelle Project to
identify best practices in laboratory medicine
• Department of Transportation (DOT): Provides the regulations
for shipment of biological and hazardous materials, including
clinical laboratory specimens
• Occupational Safety and Health Administration (OSHA): Main
federal agency charged with enforcement of safety and health
legislation
ACCREDITATION
All U.S. clinical laboratories that apply for a Certificate of Accreditation must be certified by
one of the seven deemed status accreditation organizations designated on the CMS website
• American Association of Blood Banks (AABB): Accreditation is granted for collection,
processing, testing, distribution, and administration of blood and blood components;
hematopoietic progenitor cell activities; cord blood activities; perioperative activities;
relationship testing activities; immunohematology reference laboratories; and Specialist in
Blood Bank schools
• American Association for Laboratory Accreditation: provides accreditation services and
training
• American Osteopathic Association (AOA): The AOA Healthcare Facilities Accreditation
Program (HFAP) is authorized by the CMS to survey hospitals, clinical laboratories, and other
health care facilities for compliance with CMS standards
• American Society for Histocompatibility and Immunogenetics (ASHI):
Accreditation program to evaluate laboratory personnel, procedures, and facilities to
determine if they are in compliance with published standards of ASHI and standards
of organizations by which ASHI is deemed: HCS/BM Transplantation—Related and
Unrelated Donor; Solid Organ Transplantation—Deceased and Live Donor;
Parentage Testing; Histocompatibility Testing; and Transfusion Support
• American Society for Histocompatibility and Immunogenetics (ASHI):
Accreditation program to evaluate laboratory personnel, procedures, and facilities to
determine if they are in compliance with published standards of ASHI and standards
of organizations by which ASHI is deemed: HCS/BM Transplantation—Related and
Unrelated Donor; Solid Organ Transplantation—Deceased and Live Donor;
Parentage Testing; Histocompatibility Testing; and Transfusion Support
• College of American Pathologists (CAP): Laboratory Accreditation Program meets
the needs of a variety of laboratory settings from complex university medical centers
to physician office laboratories. The program also covers a complete array of
disciplines and testing procedures. Because of its comprehensive nature, CAP
accreditation can help achieve a consistently high level of service throughout an
institution or health care system
• COLA: First organization to be renewed since increased government scrutiny of
survey organizations and was given permission to accredit laboratories for the next 6
years to help laboratories meet CLIA requirements. The increase in oversight by CMS
was driven by a government investigation in 2006 into how some highly publicized
laboratory errors had occurred and could have been prevented
• The Joint Commission (TJC) accredits more organizations than any other agency in
health care. It accredits more than18,000 health care organizations, including
approximately 3000 clinical laboratories