INTERNATIONAL BODIES RELATED TO THE PROFESSION OF MLS

1. Clinical and Laboratory Standards Institute (CLSI)

- formerly known as: National Committee for Clinical Laboratory Standards
(NCCLS)
- aim: Fostering excellence in laboratory medicine
- nonprofit organization
- develops clinical laboratory testing (from the industry, government, and healthcare
professionals) standards [level of quality that is considered acceptable] and guidelines
* Vision: quality practices for better health
* Mission: develop clinical and laboratory practices and promote their use worldwide
- Common publications:
> M100 (Microbiology): performance standards for Antimicrobial
Susceptibility Testing (AST)
> GP41 (General Phlebotomy): collection of diagnostic venous blood
specimens
> GP48 (General Phlebotomy): essential elements of a phlebotomy
training program
> QMS01 (Quality Management Services): a quality management
system model for laboratory services

2. American Society for Clinical Pathology (ASCP)

- Chicago, Illinois
- advocate for the recognition of pathologists and medical laboratory professionals

3. American Society for Clinical Pathology Board of Certification (ASCPBOC)

- previous certification for global generalists

4. National Institute of Standards and Technology (NIST)

- oldest physical laboratory under the US department of commerce
- promotes innovation and competitiveness by advancing measurement of science,
standards, and technology
- contributions: Class A [maximizes accuracy and precision] tolerance for laboratory
glassware (serological pipettes, beakers, biurets, and graduated cylinders)
: production of standards used for calibration of laboratory instruments
(NIST class “S” weights – calibrating analytical balances)

LABORATORY ACCREDITING BODIES

1. International Organization for Standardization
- independent and nongovernmental organization with 164 national standard bodies
- function: develops and provides common standards (food, agriculture, and
healthcare)
- provides internationally recognized accreditations
 > ISO 9001: “quality management systems-requirements” (ex. Region 1
Medical Center)
> ISO 15189: medical laboratory requirements for quality and competence
: provides standards for technical competence that are unique to
medical laboratories
: provides quality management system similar to ISO 9001 but
within the context of Medical Laboratory setting

2. College of American Pathology

- member-based physician organization – Pathologists: American Board of Pathology
- offers accreditation services to help laboratories earn accreditation under ISO 15189
- accreditation program:
> peer-based accreditation inspection model
> performs onsite inspections every 2 years using CAP accreditation checklists
* all common checklist (COM) – contains a corset of requirements that
apply to all areas performing laboratory tests and procedures
* discipline specific checklist – assigned for a specific working area in
the laboratory

3. The Joint Commission

- formerly Joint Commission on Accreditation of Hospitals and Joint Commission on
Accreditation of Healthcare Organizations
- certifies healthcare organizations and programs across the US

4. American Association of Blood Banks (AABB)

- global leader in standards development, accreditation and implementation of quality
systems regarding transfusion and cellular therapies
- to make TM and CM safe, available, and effective
- [Donor>Product>Recepient>Transfusion Outcome]

5. Centers for Disease Control and Prevention (CDC)

- under the US department of Health and Human Services
- aim: protecting the public from health, safety, and security threats
- provides standard guidelines for biosafety and biosecurity practices
- provides standards that help laboratory manage the presence of biohazards
(biological or chemical substances that are dangerous/may cause a threat to the human health
[ebola virus and bioterrorism – anthrax bacteria])
- manual: Biosafety in Microbiological and Biomedical Laboratories (5th edition) in
partnership with NIST