CMS SOM App. C, Tag D5291

(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 general laboratory systems requirements specified at §§493.1231

through 493.1236.

Interpretive Guidelines §493.1239(a)

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 the other 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 General Laboratory System includes assessing practices/issues related to:

• Patient confidentiality;

• Specimen identification and integrity;

• Complaint investigations;

• Communications;

• Personnel competency; and

• Proficiency testing performance.

Probes §493.1239(a)

Does the laboratory have a system in place for monitoring and evaluating confidentiality

of patient information?

How does the laboratory ensure that an individual who had problems in performance is

competent after appropriate retraining and technical assistance is completed?

How does the laboratory determine which complaints require investigation and which do

not?