CMS SOM App. C, Tag D8103

issued a CLIA certificate and CLIA-exempt laboratories.

(b) General Requirements. As part of the inspection process, CMS or a CMS agent

may require the laboratory to do the following:

Interpretive Guidelines §493.1773(b)-(c)

The regulations do not require a laboratory to maintain records on-site. During the

survey, the laboratory must be able to retrieve copies of all records and necessary

information upon request. Determine what constitutes a reasonable timeframe based on

the information requested.

(b)(1) Test samples, including proficiency testing samples, or perform procedures.

(b)(2) Permit interviews of all personnel concerning the laboratory’s compliance

with the applicable requirements of this part.

(b)(3) Permit laboratory personnel to be observed performing all phases of the total

testing process (preanalytic, analytic, and postanalytic).

(b)(4) Permit CMS or a CMS agent access to all areas encompassed under the

certificate including, but not limited to, the following:

(b)(4)(i) Specimen procurement and processing areas.

(b)(4)(ii) Storage facilities for specimens, reagents, supplies, records, and reports.

(b)(4)(iii) Testing and reporting areas.

(b)(5) Provide CMS or a CMS agent with copies or exact duplicates of all records

and data it requires.

(c) Accessible Records and Data. A laboratory must have all records and data

accessible and retrievable within a reasonable time frame during the course of the

inspection.

(d) Requirement to Provide Information and Data. A laboratory must provide,

upon request, all information and data needed by CMS or a CMS agent to make a

determination of the laboratory’s compliance with the applicable requirements of

this part.