BOP Program Statement 6370.02 § 5

a. Scope of Services. A CLIA Certificate of Accreditation will be maintained in each of the

Bureau MRCs. There will be two types of accredited laboratories. Each type will be assessed and

assigned in collaboration between the Medical Director and NLA. The two accredited laboratory

types will be labeled as follows:

 MRC Laboratories

 Medical Referral Laboratories (MRL)

Accreditation must be obtained through a nationally recognized accrediting body determined by

the Medical Director and NLA. Only nonwaived testing will be authorized for use and/or

oversight within the accredited laboratories.

MRCs may also obtain a separate CLIA Certificate of Waiver if oversight and testing are not

included within the accredited laboratory. These facilities will collaborate with the NLA to

determine oversight responsibility of the waived testing program.

 MRC Laboratories.

 MRC Laboratories will serve as the primary source for routine and STAT testing for

the local inmate population. The laboratory will only perform the tests approved by

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the LD and NLA. The approved menu will be reviewed and published annually in the

Laboratory Services section on the Bureau’s intranet site.

 MRC Laboratories’ leadership structure will include a qualified LD and laboratory

supervisor. Testing personnel may include medical laboratory scientists and/or

medical laboratory technicians. Other support personnel can include health services

assistants and/or phlebotomists.

 Medical Referral Laboratories.

 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. The

laboratory will only perform the tests approved by the LD and NLA. A specimen

collection and processing manual will be provided by each MRL's assigned facilities.

 MRL leadership structure will include a qualified LD, laboratory manager, and

laboratory supervisors. Testing personnel will include medical laboratory scientists

and/or medical laboratory technicians. Other support personnel can include health

services assistants and/or phlebotomists.

b. Laboratory Requirements. Laboratories holding a CLIA Certificate of Accreditation will

meet the following core requirements (in addition to Subpart M of all applicable CLIA

Regulation Subparts). The following elaborations are provided to assist non-laboratory

healthcare professionals in understanding the intent and application of each requirement.

Regulatory citations reference 42 C.F.R. Part 493.

 Laboratory Director qualifications. Regulatory Reference: 42 C.F.R. § 493.1405; 42

C.F.R. § 493.1443; 42 C.F.R. Part 493, Subpart M

 The laboratory must have a qualified LD who meets specific educational and

experience requirements based on the complexity of testing performed. The director

is ultimately responsible for all laboratory operations, including test quality, staff

competency, and regulatory compliance. This person may not simply be an

administrator – they must have demonstrated scientific and clinical expertise

appropriate to the level of testing performed.

 Proficiency testing. Regulatory Reference: 42 C.F.R. Part 493, Subpart H; 42 C.F.R. §

493.1236

 Laboratories must enroll in and participate in a Health & Human Services (HHS)-

approved external Proficiency Testing (PT) program for each specialty and

subspecialty for which they seek certification. PT involves receiving unknown

samples from an outside organization, testing them in the same manner as patient

specimens, and submitting results for graded comparison. Successful PT performance

is required to maintain CLIA certification. Unsuccessful PT may trigger corrective

action and, if persistent, can result in loss of testing privileges for the affected test.

Intentional referral of PT samples to another laboratory for analysis may result in

certificate revocation.

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 Quality management. Regulatory Reference: 42 C.F.R. Part 493, Subpart K; 42 C.F.R. §

493.1239

 The laboratory must maintain a comprehensive Quality Management (QM) system

that monitors all phases of testing – before the sample is collected (pre-analytical),

during testing (analytical), and after results (post-analytical) are reported. This

includes tracking errors, monitoring turnaround times, reviewing complaints, and

identifying opportunities for improvement. Laboratories must document all quality

assessment activities, review the effectiveness of corrective actions, and discuss

findings with appropriate staff. QM is an ongoing, systematic process – not a one-time effort.

 General issues. Regulatory Reference: 42 C.F.R. §§ 493.1231–493.1234; 42 C.F.R. Part

493, Subpart J

 This category covers broad operational standards that apply across the laboratory,

including appropriate test ordering, patient identification, confidentiality of results,

and communication of critical values. Laboratories must have clear policies

addressing how general day-to-day operations are conducted and how deviations from

standard practice are identified and resolved. Laboratories must also document

complaints and investigate problems arising from breakdowns in communication

between the laboratory and ordering providers.

 Written Quality Management/Quality Control program. Regulatory

Reference: 42 C.F.R. § 493.1256; 42 C.F.R. Part 493, Subpart K

• The laboratory must have a documented, written Quality Control (QC)

program that defines how the accuracy and precision of test results are

monitored every day. For each test system, control procedures must be

performed using the number and frequency specified by the manufacturer, or

as established by the laboratory when they meet or exceed regulatory

requirements. At a minimum, control procedures must be performed, at least

once, each day patient specimens are tested. This written program must

specify acceptable QC ranges, corrective actions when QC fails, and

documentation requirements.

 Unusual laboratory results. Regulatory Reference: 42 C.F.R. §§ 493.1232–

493.1233; 42 C.F.R. § 493.1291

• Laboratories must have policies to identify, investigate, and communicate

results that fall outside expected ranges or that are clinically unexpected. This

includes delta checks (comparing a patient's current result to their previous

result), critical value notification, and investigation of results that may

indicate specimen integrity issues or instrument malfunction. Non-laboratory

staff should understand that unusual results trigger a defined internal review

process before being acted upon clinically. Laboratories must document all

complaint investigations and problems identified.

 Supervisory result review. Regulatory Reference: 42 C.F.R. § 493.1407; 42

C.F.R. § 493.1445; 42 C.F.R. Part 493, Subpart M

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• Qualified laboratory supervisors must review test results before they are

finalized and reported. This is particularly important for complex or high-risk

tests. Supervisory review ensures results are accurate, complete, and clinically

plausible. Supervisors are also responsible for reviewing QC data, flagging

potential errors, and authorizing result release in accordance with laboratory

policy. Personnel requirements for supervisors are defined separately based on

testing complexity.

 Instrument/equipment record review. Regulatory Reference: 42 C.F.R. §

493.1252; 42 C.F.R. § 493.1254; 42 C.F.R. § 493.1255

• Laboratories must maintain and regularly review complete records for all

instruments and equipment used in testing. These records include maintenance

logs, calibration records, function check records, and repair histories.

Calibration and calibration verification procedures are required to confirm the

continued accuracy of the test system throughout the laboratory's reportable

range. Equipment that is out of service or malfunctioning must be clearly

identified and removed from use until repairs are verified.

 Comparability of instruments/methods. Regulatory Reference: 42 C.F.R. §

493.1253; 42 C.F.R. § 493.1289

• When a laboratory uses more than one instrument or method to perform the

same test, it must demonstrate that the results produced are comparable, i.e., a

patient would receive essentially the same result regardless of which

instrument or method was used. This is critical in settings where multiple

analyzers run the same test across shifts or locations. Laboratories must

perform and document comparability studies whenever new instruments are

added, or significant changes are made to existing methods.

 Comparability criteria. Regulatory Reference: 42 C.F.R. § 493.1253(b); 42

C.F.R. § 493.1289

• Laboratories must define the specific, measurable criteria used to determine

whether instruments or methods are producing comparable results. These

criteria must be established in advance and must be clinically meaningful, i.e.,

any allowable difference between instruments must not be large enough to

affect patient care decisions. Documentation of these criteria and the results of

comparability testing must be maintained as part of the laboratory's quality

records.

 Specimen collection and handling. Regulatory Reference: 42 C.F.R. § 493.1232;

42 C.F.R. § 493.1242

• The laboratory must establish and follow written policies and procedures

which ensure positive identification and optimum integrity of a patient's

specimen from the time of collection or receipt through completion of testing

and reporting of results. Non-laboratory staff involved in specimen collection,

such as nurses and phlebotomists, must follow laboratory-defined procedures,

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including correct tube types, collection order, volume requirements, and

temperature conditions for transport. Improper collection or handling is one of

the most common sources of laboratory error and can result in inaccurate

results.

 Procedure manuals. Regulatory Reference: 42 C.F.R. § 493.1251

• A written procedure manual for all tests, assays, and examinations performed

by the laboratory must be available to and followed by laboratory personnel.

Textbooks may supplement but not replace the laboratory's written

procedures. The procedure manual must include requirements for patient

preparation; specimen collection, labeling, storage, preservation,

transportation, and processing; step-by-step performance of the procedure;

calibration and calibration verification procedures; the reportable range; and

corrective actions when QC fails. Procedure manuals must be reviewed and

approved annually by the LD.

 Results reporting. Regulatory Reference: 42 C.F.R. § 493.1291; 42 C.F.R. Part

493, Subpart K

• Laboratory results must be reported in a clear, accurate, and timely manner to

authorized individuals. Reports must include the patient's name and identifier,

the test name, result, units of measurement, reference intervals, and the

laboratory's name and address.

• Critical values must be communicated immediately to the responsible

clinician. Each facility will develop a local procedure for reviewing and acting

upon abnormal laboratory values to ensure prompt and appropriate follow-up

to abnormal lab results, including critical labs.

• Laboratories must also have policies for amended reports when errors are

corrected after initial release. Requests for corrected reports are forwarded to a

health informatic specialist with the basis for correction.

 Reagents. Regulatory Reference: 42 C.F.R. § 493.1252

• All test systems, equipment, instruments, reagents, materials, and supplies

used in laboratory testing must be monitored to ensure they are acceptable for

performing the type of testing required. Reagents must be labeled with lot

numbers and expiration dates, and expired reagents must never be used for

patient testing. Laboratories must document receipt, quality checks, and any

issues with reagents. Reagent failure is a recognized cause of inaccurate

results and must be addressed through the laboratory's corrective action

process.

 Instruments and equipment. Regulatory Reference: 42 C.F.R. § 493.1252; 42

C.F.R. § 493.1254; 42 C.F.R. § 493.1255

• The laboratory must maintain all instruments and equipment in proper

working order through a defined preventive maintenance and function check

program. Each instrument must be calibrated on a schedule that meets

manufacturer and regulatory requirements. Records of all maintenance,

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calibration, and corrective actions must be retained. Equipment that is out of

service or malfunctioning must be clearly identified and removed from use

until repairs are verified and documented.

 Test method validation/verification. Regulatory Reference: 42 C.F.R. §

493.1253

• Before any new test is introduced into clinical use, the laboratory must

establish or verify the performance specifications of the test system. For FDA-cleared or approved test systems, the laboratory must verify performance

specifications are achievable. For laboratory-developed tests or modified

FDA-cleared tests, the laboratory must establish performance specifications.

This process includes evaluating accuracy, precision, and reportable range.

Results must be reviewed and approved by the LD before patient testing

begins.

 Method Performance Specifications. Regulatory Reference: 42 C.F.R. §

493.1253; 42 C.F.R. § 493.1251(b)(9)

• Each test method must have clearly defined performance specifications,

including the analytical measurement range (the range of values the test can

accurately measure), precision (reproducibility of results), accuracy (closeness

to the true value), and any known interferences or limitations in the

methodology. These specifications guide clinical interpretation and help

clinicians understand the limitations of any given test result. Limitations in

test methodology, including interfering substances, must be documented in the

procedure manual.

 Reference intervals. Regulatory Reference: 42 C.F.R. § 493.1253(b)(4); 42

C.F.R. § 493.1251

• Reference intervals define the expected range of results for a healthy

population. Laboratories must verify the reference intervals they use are

appropriate for their patient population, taking into account factors such as

age, sex, and specimen type. If a laboratory's patient population differs

significantly from the population used to establish published reference

intervals, the laboratory must establish its own reference intervals. Reference

intervals must be included in the procedure manual and reviewed and updated

as needed.

 Personnel requirements. Regulatory Reference: 42 C.F.R. Part 493, Subpart M;

42 C.F.R. § 493.1235

• All laboratory personnel must meet minimum qualifications based on the

complexity of the tests they perform. CLIA defines specific education,

training, and experience requirements for testing personnel, technical

supervisors, laboratory supervisors, and laboratory directors performing

moderate and high complexity testing. Laboratories must establish and follow

written policies and procedures to assess staff competency and must review

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and evaluate the results of that assessment. Competency must be assessed at

least annually for all testing personnel.

 Physical Facilities. Regulatory Reference: 42 C.F.R. Part 493, Subpart J

• The laboratory must maintain a safe and functional physical environment that

supports accurate testing. This includes adequate space, appropriate lighting,

temperature and humidity control, proper ventilation, and safe storage of

chemicals and biological materials. Facilities must be designed and

maintained to prevent contamination, protect specimen integrity, and support

the workflow necessary for the volume and complexity of testing performed.

Laboratories must also comply with applicable federal, state, and local facility

requirements.

 Laboratory Safety. Regulatory Reference: 42 C.F.R. Part 493, Subpart J; 29

C.F.R. Part 1910 – Occupational Safety and Health Standards

• Laboratories must comply with all applicable safety regulations in addition to

CLIA, including those established by the Occupational Safety and Health

Administration (OSHA), the Centers for Disease Control and Prevention

(CDC), and applicable state and local authorities. This includes programs for

bloodborne pathogen exposure prevention, chemical hygiene, fire safety, and

electrical safety. Laboratories must maintain Safety Data Sheets (SDS) for all

hazardous chemicals, provide appropriate personal protective equipment

(PPE), and train all personnel in safety practices. A safe laboratory

environment protects not only laboratory staff, but also patients and other

healthcare workers who interact with the laboratory.

c. Laboratory Equipment and Supplies Standardization. The Bureau will standardize

specified laboratory-related equipment and supplies. National contracts will be attained to assist

with standardization. Health Services Administrators and appropriate laboratory leadership are

expected to work within all applicable laboratory national agreements. The NLA will assist

facilities in obtaining laboratory equipment and supplies through these national agreements.

d. Blood Transfusion Services. Accredited laboratories have the option, depending on their

mission, to have a blood transfusion service. Facilities opting to have a blood transfusion service

will comply with the following specific requirements:

 Under no circumstances will Bureau laboratories perform donor collection or blood-component processing. Under this program statement, transfusion services are limited to

storage, compatibility testing, and administration.

 Personnel in the transfusion service will have sufficient training and/or experience and

demonstrate technical competence in the performance of immunohematology procedures

performed.

 Institutions performing blood transfusions will have written policies and procedures

which conform to all applicable accrediting standards.

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 Any provider can order a transfusion, but orders for transfusion must be reviewed and co-signed by a physician before the lab can process the order and distribute units.

These policies and procedures will be readily available to staff and will be reviewed at least

every two years by the LD and revised as necessary.

 Blood or blood components will be stored and handled in such a manner that they retain

their maximum efficacy and safety. They will be properly processed, tested, and labeled.

 Refrigerators used for the routine storage of blood will conform to all specifications of

the applicable accrediting blood banking standards. The proper functioning of the

refrigerator will be constantly monitored as outlined by accrediting standards.

 A written procedure will be established for always obtaining necessary blood and blood

components. It will be documented that stored blood is inspected daily for evidence of

hemolysis and for possible bacterial contamination.

 Blood and blood components will be obtained only from FDA-licensed blood

establishments. Selection of the supplier will be approved by the LD and institution

leadership.