CMS SOM App. C, Tag D5891

(a) The laboratory must establish and follow written policies and procedures for an

ongoing mechanism to monitor, assess and, when indicated, correct problems

identified in the postanalytic systems specified in §493.1291.

Interpretive Guidelines §493.1299(a)-(c)

Quality Assessment (QA) is an ongoing review process that encompasses all facets of the

laboratory’s technical and non-technical functions and all locations/sites where testing is

performed. QA also extends to the laboratory’s interactions with and responsibilities to

patients, physicians, other laboratories ordering tests, and non-laboratory areas of the

facility of which it is a part.

When the laboratory discovers an error or identifies a potential problem, actions must be

taken to correct the situation. This correction process involves investigation,

identification, and resolution of the problem, followed by development of policies that

will prevent recurrence.

The laboratory should:

• Establish and/or revise written policies and procedures to prevent recurrence of

the problems identified;

• Communicate the established and/or revised policies to the laboratory personnel

and other staff, clients, etc., as appropriate; and

• Document that the established and/or revised policies and procedures to prevent

recurrence have been followed.

Over time, the laboratory must document monitoring of the corrective action(s) to ensure

the action(s) taken have prevented recurrence of the original problem.

All pertinent laboratory staff must be involved in the assessment process through

discussions or active participation.

QA of the Postanalytic System includes assessing practices/issues related to test reports.

Examples include monitoring and evaluating the accuracy, timeliness, and completeness

of the laboratory’s test reports (i.e., patient information, test results, normal ranges, and

the disposition of unacceptable specimens), and the laboratory’s turn-around times and

procedures for notification of test results e.g., routine tests, STATS, abnormal or panic

values, and downtime procedures.

Review a cross-section of patient test reports for accuracy of patient information, test

results and normal ranges to verify that the laboratory is effectively monitoring and

evaluating the quality and accuracy of the information supplied to its clients.

Verify that the laboratory has a system in place to monitor and evaluate its established

reporting time frames and procedures for notification of test results, routine tests,

STATS, abnormal or panic values.

If the laboratory uses an LIS, the laboratory must have a mechanism to periodically

verify the accuracy of:

• Its calculated data;

• Its results sent to interfaced systems; and

• Patient specific data.

Laboratories should assess data security protocols as part of the laboratory’s quality

assessment.

In the event that the laboratory becomes aware of information that reasonably suggests

that an in vitro diagnostic device may have caused or contributed to a patient death or

serious injury, verify that the laboratory has reported such instances to the FDA.

Reports must be submitted on FDA Form 3500A

(https://www.fda.gov/medwatch/getforms.htm) or an electronic equivalent as soon as

practical, but no later than 10 days from the time personnel become aware of the event.

For more information on reporting requirements, contact the FDA: Office of In Vitro

Diagnostic Device Evaluation and Safety, Center for Devices and Radiological Health,

Food and Drug Administration, HFZ-440, 2098 Gaither Road, Rockville, MD 20850,

Phone: 240-276-0450, Fax: 240-276-0652.