CHAPTER 13

INSPECTIONS

13-1. Condition: Inspection of laboratories issued a certificate for minimal complexity (§493.1775)

a. TSG or their designee may conduct announced or unannounced inspections of any laboratory at any time during its hours of operation to assess compliance with the applicable requirements of DoD CLIP.

b. The laboratory may be required, as part of this inspection, to:

(1) Permit TSG or their designee to interview all employees of the laboratory concerning the laboratory's compliance with the applicable requirements of DoD CLIP.

(2) Permit TSG or their designee access to all areas of the facility including the following:

(a) Specimen procurement and processing areas.

(b) Storage facilities for specimens, reagents, supplies, records, and reports.

(c) Testing and reporting areas.

(3) Permit employees to be observed performing tests, data analysis and reporting.

(4) Permit TSG or their designee, upon request, to review all information and data necessary to:

(a) Determine that testing is being performed or the laboratory is being operated in a manner that does not constitute an imminent and serious risk to public health.

(b) Evaluate complaints from patients, commanders or other users. Reports of complaint inspections are governed by 10 U.S.C. 1102 as quality assurance documents.

(c) Determine whether the laboratory is performing tests not listed in paragraph 2-3.

(d) Collect information to determine the addition, deletion, or continued inclusion of tests listed in paragraph 2-3.

(5) Provide copies to TSG or their designee of all records and data that the agency requires under these regulations.

c. The laboratory must provide, upon reasonable request, all information and data needed by TSG or their designee to make a determination of compliance with the requirements of DoD CLIP.

13-2. Condition: Inspection of laboratories issued a certificate for provider-performed microscopy (PPM) procedures (§493.1776)

a. TSG or their designee will conduct announced or unannounced inspections of any laboratory during its hours of operation to:

(1) Determine that testing is being performed or the laboratory is being operated in a manner that does not constitute an imminent and serious risk to public health.

(2) Evaluate complaints from patients, commanders or other users. Reports of complaint inspections are governed by 10 U.S.C. 1102 as quality assurance documents.

(3) Determine whether the laboratory is performing tests in addition to procedures specified as PPM procedures.

(4) Collect information regarding the appropriateness of tests specified as PPM procedures.

b. The laboratory may be required, as part of this inspection, to:

(1) Permit TSG or their designee to interview all employees of the laboratory concerning the laboratory's compliance with the applicable requirements of DoD CLIP.

(2) Permit TSG or their designee access to all areas of the facility including:

(a) Specimen processing areas.

(b) Storage facilities for specimens, requests, supplies, records, and reports.

(c) Testing and reporting areas.

(3) Permit providers to be observed performing tests and reporting results.

(4) Permit TSG or their designee, upon request, to review all information and data necessary to:

(a) Determine that testing is being performed or the laboratory is being operated in a manner that does not constitute an imminent and serious risk to public health.

(b) Evaluate complaints from patients, commanders or other users.

(c) Determine whether the laboratory is performing tests in addition to procedures specified as PPM procedures.

(d) Collect information to determine appropriateness of tests specified as PPM procedures.

(5) Provide copies to TSG or their designee of all records and data that the agency requires under these regulations.

c. The laboratory must provide, upon reasonable request, all information and data needed by TSG or their designee to make a determination of compliance with the requirements of DoD CLIP.

d. Failure to permit an inspection under this subsection may result in suspension, revocation or limitation of a laboratory's certificate in accordance with Chapter 14.

13-3. Condition: Inspection of all laboratories requesting or issued a certificate of compliance (§493.1777)

Laboratories requesting or issued a certificate of compliance must permit an inspection to assess compliance with DoD CLIP. (Reports of complaint inspections are governed by 10 U.S.C. 1102 as quality assurance documents.) Testing in the subcategory of PPM procedures, may be included in the laboratory's routine or complaint inspection. PPM procedures are assessed for compliance with only the applicable requirements specific to the subcategory testing.

a. TSG or their designee may conduct announced or unannounced inspections on at least a biennial basis of any laboratory at any time during its hours of operation. To assess compliance with the requirements of DoD CLIP,
TSG or their designee will inspect a laboratory possessing a registration certificate before issuance of a certificate of compliance.

b. The laboratory may be required, as part of this inspection, to:

(1) Test samples (including proficiency testing samples) or perform procedures as TSG or their designee requires.

(2) Allow TSG or their designee to interview all employees of the laboratory concerning the laboratory's compliance with the applicable requirements of DoD CLIP.

(3) Permit employees to be observed performing tests (including proficiency testing specimens), data analysis and reporting.

(4) Permit TSG or their designee access to all areas of the facility including:

(a) Specimen procurement and processing areas.

(b) Storage facilities for specimens, reagents, supplies, records, and reports.

(c) Testing and reporting areas.

(5) Provide copies to TSG or their designee of all records and data required.

c. The laboratory must have all records and data accessible and retrievable within a reasonable time frame during the course of the inspection.

d. The laboratory must retain:

(1) Immunohematology records for a period of not less than 5 years, in accordance with 21 CFR Part 606,
Subpart I.

(2) Pathology test reports for at least 10 years after the date of reporting as required in para- graph 9-5.

(3) All other laboratory records for at least 2 years.

e. The laboratory must provide upon request all information and data needed by TSG or their designee to make a determination of the laboratory's compliance with the applicable requirements of DoD CLIP.

f. TSG or their designee may reinspect a laboratory at any time necessary to evaluate the ability of the laboratory to provide accurate and reliable test results.

13-4. Condition: Inspection of accredited DoD laboratories (§493.1780)

a. OASD(HA), TSG, or their designee may conduct announced or unannounced, random validation inspections of any accredited DoD laboratory at any time during its hours of operation.

b. OASD(HA), TSG, or their designee will conduct unannounced complaint inspections of an accredited DoD laboratory at any time during its hours of operation upon receiving a complaint about that laboratory. Reports of complaint inspections are governed by 10 U.S.C. 1102 as quality assurance documents.

c. The laboratory may be required, as part of either of the above inspections, to:

(1) Test samples (including proficiency testing samples) or perform procedures as required by OASD(HA), TSG, or their designee.

(2) Allow OASD(HA), TSG, or their designee to interview all employees of the laboratory concerning the laboratory's compliance with the applicable requirements of DoD CLIP.

(3) Permit employees to be observed performing tests (including proficiency testing specimens), and performing data analysis and reporting activities.

(4) Permit OASD(HA), TSG, or their designee access to all areas of the facility including:

(a) Specimen procurement and processing areas.

(b) Storage facilities for specimens reagents, supplies, records, and reports.

(c) Testing and reporting areas.

(5) Provide copies to OASD(HA), TSG, or their designee of all records and data required under these requirements.

d. The laboratory must have all records and data accessible and retrievable within a reasonable time during the inspection.

e. The laboratory must retain:

(1) Immunohematology records for a period of not less than 5 years, in accordance with 21 CFR Part 606, Subpart I.

(2) Records of blood and blood product testing for a period of not less than 5 years after processing records have been completed, or 6 months after the latest expiration date, whichever is the later date, in accordance with 21 CFR Part 606.160d.

(3) Pathology test reports for at least 10 years after the date of reporting, as required in paragraph 9-5.

(4) All other laboratory records for at least 2 years unless otherwise specified in DoD CLIP.

f. The laboratory must provide, upon request, all information and data needed by OASD(HA), TSG, or their designee to make a determination of compliance or noncompliance with the applicable requirements of DoD CLIP.

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