CMS SOM App. C, Tag D3007

(b) The laboratory must have appropriate and sufficient equipment, instruments,

reagents, materials, and supplies for the type and volume of testing it performs.

Interpretive Guidelines §493.1101(b)

Base deficiencies related to inappropriate or insufficient equipment on a determination

that patient results are or may be adversely affected. Ensure that the laboratory has the

appropriate equipment to prepare reagents, stains, solutions, controls, and calibration

materials (e.g., pipettes, hydrometers, graduated cylinders, autoclaves, balances,

centrifuges, distilled/deionized water). If the equipment or instrumentation is found to be

inappropriate or insufficient, document the reasons for this finding.

Ensure that the laboratory has test systems, equipment and/or instruments capable of

producing results within the laboratory’s stated test performance specifications.

Ensure that the laboratory has test systems, equipment and/or instruments necessary to

perform the laboratory’s volume of testing (preanalytic, analytic, postanalytic) within

established turnaround times.

Data capacity in the laboratory’s information system should be sufficient for current data

entry. If capacity is maintained by deletion of data, it should be scheduled and

documented.

For Cytology, laboratories should use coverslips that cover the entire surface of the

specimen.