Laboratory Compliance

*A CLIA certificate issued to a laboratory for physicians, midlevel practitioners, or dentists to perform procedures (a predetermined list of tests), as well as tests on specimens collected during a physical examination. Laboratories with this category CLIA certificate may also perform waived testing.*

*CLIA*

*A voluntary organization that accredits hospitals and health care organizations*

*HIPAA*

*National standards that ensure equal access to certain health and human services and protect the privacy and security of health information*

*HIPAA*

A set of quality standards mandated by the federal government to ensure accuracy, reliability, and timeliness of patient test results in which standards apply to all clinical laboratory testing and is the foundation for all accreditation agencies

Accreditation Standards

An international non-profit association representing individuals and institutions involved in the field of transfusion medicine and cellular therapies

American Association of Blood Banks (AABB)

A medical society, composed of pathologists, providing laboratory quality improvement programs with accreditation

CAP

A federal agency under the Department of Health and Human Services that protects public health and safety through the control and prevention of disease, injury, and disability

CDC

A federal agency of the US Department of Health Human Services (USDHHS). One of its responsibilities includes categorizing test methods for complexity

CLIA

A physician-directed voluntary organization that initially accredited only physician office laboratories. Today, they also accredit other test sites including those located in small hospitals.

COLA

A CLIA certificate that permits a site to perform only those test methods identified as waived

Certificate of Waiver

The adherence to applicable requirements, rules, standards, regulation,s and guidelines to maintain licensure and accreditation

Compliance

The most difficult laboratory testing determined by examining seven criteria among which are test system, troubleshooting, test interpretation, and judgement

High Complexity

The middle level of laboratory testing determined by the examination of knowledge, training and experience, and calibration, quality control, and proficiency testing materials plus four other criteria

Moderate Complexity

For quality control and quality assessment CLIA requirements, moderate and high complexity are grouped and referred to as this

Nonwaived Testing

A federal organization that is responsible for regulations relating to the general workplace safety and protecting the health of U.S. workers

OSHA

A mechanism to assess the internal quality for CLIA regulated analytes in testing sites performing moderated and/or high complexity testing by testing unknown samples on a scheduled bases and comparing to peers

PPM

Tests designed to be used at or near the site where the patient is located, that do not require permanent dedicated space, and that are performed outside the physical facilities of the clinical laboratories

Point-of-Care Testing

Guidelines used by various professional organizations in voluntary accreditation process of laboratories and hospitals

TJC

Laboratory tests considered simple and foolproof (such as glucose monitoring via devices cleared by the FDA for home use). Tests in this category are determined by examining seven specific criteria including reagents and materials preparation and characteristics of the operation steps

Waived Testing

The basic level of infection control precautions, which are to be used, as a minimum, in the care of all patients

Proficiency Testing