QA Module 1 - Federal Regulations and Government Organization

QM stands for:

Quality Management

QMS stands for:

Quality Management Systems

Define QMS:

process oriented, coordinated, and organized system of activities that encompass the totality of all functions involved in achieving quality and maximum customer satisfaction

Describe how a QMS is designed:

designed to detect errors and prevent them from occurring and from recurring, but does not guarantee an error free laboratory

QI stands for:

Quality Improvement

Define QI:

system or process interventions aimed at raising product quality

QA stands for:

Quality Assurance

Define QA:

proactive systematic activities to provide confidence that the quality requirements will be met

QC stands for:

Quality Control

Define QC:

process and procedures used to detect analytical errors before the release of patient results

CLIA stands for:

Clinical Laboratory Improvement Amendments

What is CLIA’s job?

a federal regulation that establishes quality standards for all laboratory testing

What does CLIA cover?

laboratory testing on specimens derived from humans, including blood, urine, and tissue

True or False: labs that perform testing on human specimens are required to be CLIA certified

true

CMS stands for:

Centers for Medicare and Medicaid Services

What is CMS’s job?

a federal agency that oversees the Medicare and Medicaid programs, charged with enforcing CLIA requirements 

True or False: CMS has the authority to impose sanctions and penalties for noncompliance

true

True or False: no agency outside of CMS is authorized to inspect and accredit medical laboratories

false

CAP stands for:

College of American Pathologists

What is CAP’s job?

provides accreditation for laboratories that meet their rigorous standards

True or False: CAP accreditation is required

false

Describe the relationship between CLIA, CMS, and CAP:

CLIA establishes quality standards for all lab testing, CMS enforces those regulations and certifications of labs, and CAP accreditation is recognized by CMS as an alternative to CLIA inspection

The Joint Commission or TJC stands for:

What is the job of the Joint Commission?

an independent, nonprofit organization that accredits and certifies healthcare organization; sets standards for quality and patient safety, conducts surveys to ensure compliance

True or False: TJC accreditation is in compliance with CLIA regulations

true

True or False: labs with TJC accreditation may still be inspected by CMS

true

FDA stands for:

Food and Drug Administration

What is the purpose of the FDA?

regulating companies who manufacture, repackage, or relabel important medical devices

What are examples of medical devices?

laboratory instruments, reagent kits, blood collection devices, and blood irradiators

True or False: the FDA is not responsible for the safety of the nation’s blood supply

false

OSHA stands for:

Occupational Safety and Health Administration

What does OSHA do?

federal agency that sets and enforces workplace safety standards

ISO stands for:

International Organization for Standardization

What does ISO do?

international organization that develops standards for various industries, including the laboratory industry

The ISO 15189 standard provides:

a framework for quality management in medical laboratories

IATA stands for:

International Air Transport Association

What does IATA do?

provides provisions that are applicable to the shipping of infectious substances, including those that are transported for laboratory testing