Laboratory Organizations, Law, & Accreditation Overview

Certification

Grants recognition or competency to persons who have satisfied predetermined qualifications.

Licensure

Right bestowed by a governmental agency to an entity to engage in a legally defined occupational scope of practice.

ASCP

American Society for Clinical Pathology.

ASCLS

American Society for Clinical Laboratory Science.

CLMA

Clinical Laboratory Management Association.

HHS

Department of Health and Human Services.

CMS

Centers for Medicare & Medicaid Services.

CDC

Centers for Disease Control and Prevention.

FDA

Food and Drug Administration.

AABB

American Association of Blood Banks.

AACC

American Association for Clinical Chemistry.

ASM

American Society for Microbiology.

ASH

American Society of Hematology.

Medical Technologist (MT)

A professional certified by ASCP.

Medical Laboratory Technician (MLT)

Created in the 1960s, requires a 2 Year, Associate Degree.

Clinical Laboratory Scientist (CLS)

Certified by NCA.

Clinical Laboratory Technician (CLT)

Certified by NCA.

Medical Laboratory Scientist (MLS)

Certification offered by ASCP Board of Certification.

Certification Exams

Exams provided by private organizations like ASCP and AMT.

Continuing Maintenance Program (CM)

A program for maintaining certification.

Specialist Examinations

Exams in specific fields such as Hematology and Microbiology.

Clinical Laboratory Improvement Amendments of 1988

Legislation impacting clinical laboratory operations.

Clinical Laboratory Fee Schedule

A schedule impacting clinical laboratory billing.

Health Insurance Portability and Accountability Act (HIPAA)

Legislation impacting patient privacy in clinical laboratories.

ASCP

American Society for Clinical Pathology; its mission is to provide excellence in education, certification, and advocacy on behalf of patients, pathologists, and laboratory professionals.

ASCLS

American Society for Clinical Laboratory Science; its mission is to make a positive impact in health care through leadership that will assure excellence in the practice of laboratory medicine.

CLMA

Clinical Laboratory Managers Association.

AABB

Association for the Advancement of Blood & Biotherapies; formerly known as the American Association of Blood Banks.

CMS

Centers for Medicare & Medicaid Services; regulates all laboratory testing performed on humans in the U.S. through the Clinical Laboratory Improvement Amendments (CLIA).

CLIA

Clinical Laboratory Improvement Amendments; establishes quality standards for laboratory testing performed on specimens from humans for the purpose of diagnosis, prevention or treatment of disease, or assessment of health.

Laboratory Law

Refers to regulations governing laboratory testing, including CLIA certification requirements for Medicare/Medicaid payments.

CLIA certificates

Different levels of CLIA certificates depending on the type of testing performed.

Clinical Laboratory Improvements Act of 1988

A law that mandates all laboratory procedures must be made available to laboratory personnel and approved by the laboratory director.

Document Control

A requirement that a copy of each procedure, date of first use, and date of discontinuance must be retained for at least 2 years after the procedure has been removed from service.

Health Insurance Portability and Accountability Act (HIPAA)

Originally enacted to protect health care coverage for those changing or losing jobs, with privacy laws enacted in 1996.

PHI

Protected Health Information.

Chain of Custody

The process of documenting each step from collection to results for medicolegal or forensic samples to maintain integrity.

Informed Consent

A process where the patient is aware, understands, and agrees to the nature of the testing and what will be done with the results reported.

Implied Consent

Consent that occurs through actions or conduct rather than direct communication.

Laboratory Safety

Includes chemical waste disposal regulations, use of hazardous chemicals, and handling of biohazardous materials.

Accreditation

The act of certifying an entity as meeting all official formal requirements to ensure competency, authority, and/or credibility.

NAACLS

National Accrediting Agency for Clinical Laboratory Science, responsible for accrediting MLS Programs.

The Joint Commission (TJC)

Accredits hospital laboratories and freestanding entities, requiring labs to be accredited by TJC, COLA, or CAP.

Commission on Laboratory Accreditation (COLA)

Founded to help laboratories meet CLIA regulations and received Deemed Status by CMS in 1993.

College of American Pathologists (CAP)

Recognized by TJC and provides peer laboratory inspection teams and proficiency testing.

AABB

Association for the Advancement of Blood & Biotherapies, formerly known as the American Association of Blood Banks.

FDA

Food and Drug Administration, involved in the regulation of laboratory practices.

Board of Certification Exams

Exams conducted by organizations such as ASCP and AMT for certification in laboratory practices.

Professional Licensure

State-specific licensure, such as that from the North Dakota Board of Clinical Lab Practice.

Professional Organizations

Organizations such as ASCP and ASCLS that support laboratory professionals.