CMS SOM App. C, Tag D5893

(b) The postanalytic systems quality assessment must include a review of the

effectiveness of corrective actions taken to resolve problems, revision of policies and

procedures necessary to prevent recurrence of problems, and discussion of

postanalytic systems quality assessment reviews with appropriate staff.

Interpretive Guidelines §493.1299(b)

Review assessment policies, procedures and reports to verify that the laboratory has a

system in place to ensure continuous improvement. Corrective action reports are one

indication that the laboratory is monitoring and evaluating laboratory performance and

the quality of services.

§493.1299(c) The laboratory must document all postanalytic systems quality

assessment activities.

Interpretive Guidelines §493.1299(c)

The steps taken by the laboratory to identify and correct problems, and prevent their

recurrence must be documented. All laboratory policies amended due to its QA activities

must be noted.

Probes §493.1299(a)-(c)

What mechanism does the laboratory use to update and correlate the information to

clients (e.g., client reference manuals), procedure manuals, reporting systems (e.g., LIS)

when the laboratory introduces a new test system with different normal/reference range?

Subpart M--Personnel for Nonwaived Testing

§493.1351 General

(Rev. 233; Issued: 09-12-25; Effective: 09-12-25; Implementation: 09-12-25)

This subpart consists of the personnel requirements that must be met by

laboratories performing moderate complexity testing, PPM procedures, high

complexity testing, or any combination of these tests.

Interpretive Guidelines §493.1351

We will continue to require individuals to submit detailed information, such as degrees,

transcripts, or Primary Source Verification (PSV) documents for verification of

educational credentials.

LABORATORIES PERFORMING PROVIDER-PERFORMED MICROSCOPY (PPM) PROCEDURES

§493.1353 Scope.

(Rev. 233; Issued: 09-12-25; Effective: 09-12-25; Implementation: 09-12-25)

In accordance with §493.19(b), the moderate complexity procedures specified as

PPM procedures are considered such only when personally performed by a health

care provider during a patient visit in the context of a physical examination. PPM

procedures are subject to the personnel requirements in §§493.1355 through

493.1365.

Interpretive Guidelines §493.1353

PPM procedures are exempt from routine inspections only when performed under a

Certificate for provider-performed microscopy procedures.