CMS SOM App. C, Tag D5391

(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 preanalytic systems specified at §§493.1241 through 493.1242.

Interpretive Guidelines §493.1249(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 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 Preanalytic System includes assessing practices/issues related to test requests,

specimen submission, handling and referral.

Some examples include: monitoring the frequency of specimen handling problems (such

as the use of an improper blood collection tube, inadequate mixing of blood specimens

with anticoagulant after collection), and delays in specimen transport; identifying clients

who repeatedly refer unacceptable specimens or improperly complete requisition forms

and documentation of the laboratory’s efforts to reduce the recurrence of these problems.

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.

Probes §493.1249(a)-(c)

When a laboratory uses off-site drawing facilities, what policies or procedures does the

laboratory use to ensure proper accountability or tracking of patient specimens from the

time of collection to receipt by the laboratory performing the tests?

Does the laboratory routinely perform a review of systems for accurate transfer of

information (e.g., manual entries by personnel from test orders to test requisition or into a

LIS)? For referral specimens, how does the laboratory check for transcription errors

when patient test information is transcribed from the laboratory’s original requisition

form to the reference laboratory’s requisition?

What actions does the laboratory take if test requisitions from one or more clients are

consistently incomplete, illegible, or contain incorrect information?

What actions does the laboratory take if specimens received from one client are

consistently unsatisfactory for testing (e.g., specimens for Cytology)? Has the

laboratory’s efforts to reduce the recurrence of these problems been documented and

effective?