Regulations and instructions for the DOD Components based on the CLIA regulations issued by the HHS. CLIA comparable regulations are similar to, but not necessarily identical to HHS CLIA regulations, modified only as may be required to meet unique aspects of DOD missions, training and preparations during peace, contingency, and wartime operations which pr...

A nurse midwife, nurse practitioner, or physician assistant who is licensed by the recognized licensing agency of a State, the District of Columbia, the Commonwealth of Puerto Rico, Guam, or the U.S. Virgin Islands, and privileged to practice his or her specialty in a DOD MTF.

The material that is to be tested by the participants in the PT program.

Medical facilities for field services, such as aid stations, clearing stations, and division, field and force combat support and evacuation hospitals; medical facilities afloat, such as hospital ships and sick bays aboard ships; and tactical casualty staging facilities and medical advance base components contained within mobile-type units.

A field of pathology concerned with the investigation of disorders of the female genital tract.

Tests taken to certify that the taker has American or Canadian high school-level academic skills. The GED is also referred to as a General Education Diploma, General Equivalency Diploma, or Graduate Equivalency Degree.

An established land-based medical center, hospital, clinic, or other facility that provides medical, surgical, or dental care and that does not fall within the definition of non-fixed MTF.

Knowing and willful noncompliance with any CLIP condition.

A certificate issued on the basis of the laboratory’s accreditation by an accrediting organization approved by Centers for Medicare & Medicaid Service (indicating that the laboratory is deemed to meet applicable CLIP requirements).

A test system cleared or approved by the FDA through the premarket notification or premarket approval process for in vitro diagnostic use. Unless otherwise stated, this includes test systems exempt from FDA premarket clearance or approval.

A certificate issued to an entity that enables that entity to conduct moderate or high complexity laboratory testing, or both, until the entity is determined to be in compliance through a survey by CCLM or their designee or is accredited by an approved accreditation organization; or becomes exempt from CLIP.

Established by HHS to advise and make recommendations on technical and scientific aspects of the provisions of Public Law 100-578, “Clinical Laboratory Improvement Amendments of 1988,” October 31, 1988.

PT determines the performance of individual laboratories for specific tests or measurements and is used to monitor laboratories’ continuing performance.

The motion of dispersed particles relative to a fluid under the influence of a spatially uniform electric field.

Includes any political subdivision to which the State has expressly delegated powers sufficient to enable it to enforce requirements equal to or more stringent than CLIA requirements.