BOP Program Statement 6370.02 § 2

Advanced Practice Provider (APP). For the purpose of this program statement, an APP is a

Nurse Practitioner or Physician Assistant.

American Society for Clinical Pathology (ASCP). A professional membership organization for

pathologists and laboratory professionals that provides education and certification.

Clinical Laboratory Improvement Amendments (CLIA). Federal regulatory standards

enacted in 1988 (with final rule published in 2003 and subsequent amendments) that apply to all

facilities performing laboratory testing on human specimens for health purposes. All facilities

performing even one test (including waived tests) on human specimens for diagnosis, prevention,

or treatment are considered laboratories under CLIA.

Certificate of Accreditation. Issued by Centers for Medicare & Medicaid Services (CMS) to

laboratories that perform nonwaived testing and are accredited by a CMS-approved accreditation

organization (e.g., College of American Pathologists, The Joint Commission).

Certificate of Waiver. Issued by CMS to facilities that perform only waived tests. A Certificate

of Waiver is the only CLIA certificate that line institutions in the Bureau are permitted to obtain.

Clinical Consultant. Provides expert medical guidance on test selection, result interpretation,

and clinical implications. Required in moderate- and high-complexity laboratories.

College of American Pathologists (CAP). A CMS-approved accreditation organization for

laboratories performing nonwaived testing. The accreditation program offered by the CAP

examines all phases of testing in the quality management aspect in the laboratory.

Competency. The demonstrated ability of testing personnel to accurately perform laboratory

testing and report results. Assessment of competency must be documented and performed

according to applicable accrediting guidelines. All testing, no matter the complexity

(waived/nonwaived) requires competency assessments.

Laboratory Accreditation. Formal recognition by a CMS-approved accreditation organization

that a laboratory meets defined standards. All laboratories at Medical Referral Centers (MRCs)

that perform nonwaived testing must maintain current accreditation from a CMS-approved

organization.

Laboratory Director (LD). The individual responsible for the overall operation and

administration of the laboratory, including ensuring timely, reliable, and clinically relevant test

results and compliance with all applicable regulations per 42 C.F.R. §493.1405/1443 for

nonwaived laboratories.

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This individual will be listed on the laboratory’s CLIA certificate and, for laboratories

performing nonwaived testing, must meet the education, training, and experience requirements

specified in 42 C.F.R. Part 493 Subpart M of the CLIA regulations. CLIA does not specify

qualifications for the LD of a facility that performs only waived tests.

Laboratory Information System (LIS). A software-based system responsible for managing

data within a working medical laboratory. System elements include workflow and data tracking

support, data exchange interfaces, and Electronic Health Record (EHR) connectivity.

Laboratory Supervisor. Oversees day-to-day testing activities and staff performance in high-complexity settings. Steps in to manage test operations and result reporting when higher-level

staff are absent.

Line Institution. A Bureau institution that is not designated as a Medical Referral Center

(MRC). These facilities constitute the majority of Bureau institutions and include Federal

Correctional Institutions (FCI), United States Penitentiaries (USP), Federal Prison Camps (FPC),

etc.

Medical Referral Center (MRC). A Bureau institution designated to provide advanced medical

and surgical care, including inpatient services and specialty consultations. Each MRC will seek

and maintain laboratory accreditation from an appropriate accrediting agency as designated by

Bureau policy.

Medical Referral Laboratory (MRL). A laboratory within an MRC that has obtained a CLIA

Certificate of Accreditation to perform nonwaived tests. MRLs will serve as the primary source

for routine and STAT testing for the local inmate population. These laboratories will also serve

as the primary source for routine laboratory testing for other geographically appropriate assigned

Bureau facilities.

MRC Laboratory. A laboratory within an MRC that has obtained a CLIA Certificate of

Accreditation to perform nonwaived tests. These laboratories will serve as the primary source for

routine and STAT testing for the local inmate population.

Nonwaived Tests. Tests classified by Federal Drug Administration (FDA) as moderate- or high-complexity under CLIA.

Point-of-Care Testing (POCT). Testing performed near or at the site of patient care. Please

note that POCT can be waived or nonwaived complexity.

Quality Control. Indicates processes and procedures designed to confirm laboratory results are

reliable, comparable, accurate, and within specified limits of acceptability.

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Technical Consultant. Provides technical oversight for moderate-complexity testing.

Responsibilities include method evaluation, validation, and troubleshooting.

Technical Supervisor. Required in high-complexity labs to supervise and troubleshoot testing.

Ensures proper implementation of technical procedures.

Testing Personnel. Staff who perform laboratory tests. Required to have proper education,

training, documented competency, and follow procedures. Competency assessments occur

periodically (six months, 12 months, and annually afterward).

Waived Laboratory. A facility holding a CLIA Certificate of Waiver.

Waived Tests. Tests cleared by FDA for home use or classified by CMS as having insignificant

risk of erroneous result, as defined by 42 C.F.R. § 493.15.