BOP Program Statement 6370.02 § 4

a. Scope of Services. Only waived testing will be authorized for use and oversight within these

facilities. Each facility will be responsible for obtaining a CLIA Certificate of Waiver. These

facilities will collaborate with the NLA to determine oversight responsibility of the waived

testing program. The NLA will approve and publish a standardized set of waived tests that can

be performed within Bureau facilities.

Bureau facilities who decide to perform waived tests will be designated as a waived laboratory.

These facilities are required to only perform waived tests as defined by CLIA and approved for

use in the Bureau by the NLA. The approved test menu will be reviewed annually by the NLA

and published in the Laboratory Services section on the Bureau’s intranet site.

6370.02 6/22/2026 PROPERTY OF US GOVERNMENT 4

Waived testing laboratory leadership will include a qualified LD. Testing personnel can include a

wide range of staff including, but not limited to, phlebotomists, health services assistants, nurses,

and APPs.

b. Waived Laboratory Requirements. Institutions performing any waived test are required to

meet the following guidelines:

 Enroll in the CLIA program by obtaining a Certificate of Waiver

 Pay the certificate fee and renew every two years

 Follow the manufacturers’ instructions for the waived tests they are performing

 Update any changes in ownership, name, address, or LD within 30 days

 Permit inspections by a CMS agent, such as a surveyor from the state agency

 Follow all applicable accrediting body waived testing requirements, which will include:

 Written policies and procedures

 LD/staff responsibilities

 Staff competency

 Quality control

 Recordkeeping

 Cleaning, disinfection, sterilization of supplies

 Compliance with laws and regulations