CMS SOM App. C, Tag D5791

(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 analytic systems specified in §§493.1251 through 493.1283.

Interpretive Guidelines §493.1289(a)-(c)

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

laboratory’s technical and non-technical functions at all location/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 Analytic System includes assessing:

• Test procedures;

• Test systems, equipment, instruments, reagents, materials, and supplies for

accuracy and reliability;

• Specimen and reagent storage condition;

• Equipment/instrument/test/system maintenance and function checks;

• Establishment and verification of method performance specifications;

• Calibration and calibration verification;

• Control procedures;

• Comparison of test results;

• Corrective actions; and

• Test records.

For Clinical Cytogenetics cases, the laboratory should identify increases in or excessive

culture failure rates, determine the contributing factors, document efforts to reduce or

eliminate these factors, and assess the effectiveness of actions taken (i.e., a decrease in

the culture failure rate).

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.

Select a sample of abnormal cytology patient reports and determine that, when available,

the histopathology comparison was performed, the cytology comparison was performed,

and the cytology 5-year retrospective review was performed. Ensure the laboratory

documents any discrepancies and performs corrective action.

Review quality control records to determine if the laboratory’s monitoring efforts are

detecting control failures, shifts, and trends. If the surveyor identifies previously

undetected quality control failures or omission, then the laboratory’s system for

monitoring and evaluating quality control may not be adequate.

For International Normalized Ratio (INR) calculation, ensure the laboratory:

• Periodically verifies, for each thromboplastin lot number in use, the correct

normal prothrombin time mean and (the International Sensitivity Index (ISI) value

are being used for calculating the INR value.

• Periodically verifies the accuracy of the INR calculation (manual, instrument or

LIS).

To verify Prothrombin time testing with INR calculations:

• Check the accuracy of normal Prothrombin time mean calculation (manual,

instrument or LIS).

• Verify the ISI used in the calculation correlates with the ISI specified in the

reagent package insert. Select an abnormal low or abnormal high prothrombin

time result and verify the calculation.

Probes §493.1289(a)

For clinical cytogenetics cases, does the laboratory monitor the frequency of culture

failures and sub-optimal analyses?

Does the laboratory add additional maintenance procedures and/or function checks, when

needed, to ensure accurate and reliable test results?

What is the laboratory’s system for monitoring and evaluating test results for

inconsistencies with patient information?