Laboratory Organizations

MLT 114 Chapter 1

List the main accreditation agencies

COLA, CAP, TJC

What agency has replaced JHAHCO?

The Joint Commission (TJC)

What does COLA stand for?

Commission on Office Laboratory Accreditation

What does CAP stand for?

College of American Pathologists

What is the purpose of accreditation? What benefit does it give?

Evaluates and recognizes that a program is meeting predetermined CLIA standards. It is voluntary, but accreditation allows labs to bill private and public health insurance

What is the entity that oversees accreditation agencies?

CLIA

What federal entities oversee and assist with CLIA operations?

FDA, CMS, PHS, HHS, CDC

What role does FDA play in a lab?

The Food and Drug Administration sets standards for waived tests and classifies certain testing as “drug” such as blood banking.

What role does CMS play for assisting CLIA?

Centers for Medicare and Medicaid Services assist with insurance billing for CLIA labs.

What role does the CDC play in CLIA accredited labs?

Centers for Disease Control and Prevention studies ways to improve lab quality and also distributes public health guidelines.

What does CLIA 88 do?

Sets document control procedures, categorizes complexity testing, regulates proficiency and inspection programs, sets requirements for training and education.

What is a waived test?

A simple test that does not required special training or education and has minimal risk of error or harm to the person performing it.

Who regulates waived tests?

FDA regulates waived tests

Wet mount microscopy, automated chemistry assays, and PPM are examples of what level of complexity tests?

Moderate complexity

Manual blood smears, Molecular testing, and ABO typing are examples of what level of complexity tests?

High complexity tests

What are the different types of accreditation?

Educational and Institutional

What are the organizations that accredit PCC as a school and as a lab?

NWCCU (Northwest Commission on Colleges and Universities) and NAACLS (National Accrediting Agency for Clinical Laboratory Sciences)

What is competency testing?

Testing done by peers to evaluate a person’s ability to perform certain lab tasks.

What is proficiency testing?

Testing run by an outside agency done annually to demonstrate the lab’s ability to perform a procedure and compare a submitted QC result to a predetermined value.

What is certification? How is it retained?

An association will grant a person or facility recognition that their training has met qualifying standards. Certification status is retained by completing CE (continuing education) units.

What are the agencies that grant certification?

ASCP (American Society for Clinical Pathology) delivers certification to those who pass the BOC (Board of Certification) exam.

What is a license?

Permission granted by a government agency that allows a person or facility to perform tasks that would otherwise be illegal if not licensed. Some states require lab employees be licensed. 

Laboratory department that analyses constituents of blood, urine, and body fluids for glucose, electrolytes, hormones, and drugs

Clinical chemistry

Laboratory department that studies formed blood elements and coagulation studies

Hematology

Lab department that provides blood products for transfusion and blood typing

Blood banking

Lab department that identifies cell markers using a specialized laser instrument

Flow cytometry

Lab department that studies pathologic microorganisms

Microbiology

Laboratory department that analyses antigens and antibodies found in serum

Immunology

What is HIPAA?

Health Insurance Portability and Accountability Act of 1996. Protects patient’s right to privacy

What is a chain of custody?

Chain of documents outlining each step of a person’s healthcare treatment and can be presented as proof under a court of law.

What sort of tests are often conducted with a chain of custody?

Drug and alcohol testing, blood tests performed for rape victims and paternity tests