CMS SOM App. C, Tag D5793

(b) The analytic 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 analytic

systems quality assessment reviews with appropriate staff.

Interpretive Guidelines §493.1289(b)

Verify that the laboratory has a system in place to monitor and evaluate test results for

inconsistencies with patient information, and for correlation between test results. For

example, a laboratory could multiply the hemoglobin result by a factor of 3, to see if the

result is equal to the hematocrit. If the laboratory has auto-validation in its Laboratory

Information System (LIS), verify that the laboratory is taking steps to reduce the

likelihood of sample-switching errors, for example, when the creatinine result is

significantly different from the patient’s previous creatinine test results, or if the MCV is

significantly different from the patient’s previous test results and the patient did not

receive a blood transfusion.

Probes §493.1289(b)

How does the laboratory address multiple failed or sub-optimal cultures that have been

submitted from one client?

How does the laboratory use the review of all normal or negative gynecologic specimens

received within the previous 5 years to assess the analytic system and communicate

findings to the staff?

(c) The laboratory must document all analytic systems assessment activities.

Interpretive Guidelines §493.1289(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 also be noted.

POSTANALYTIC SYSTEMS