CMS SOM App. C, Tag D5413

materials, and supplies.

(b) The laboratory must define criteria for those conditions that are essential for

proper storage of reagents and specimens, accurate and reliable test system

operation, and test result reporting. The criteria must be consistent with the

manufacturer’s instructions, if provided. These conditions must be monitored and

documented and, if applicable, include the following:

(b)(1) Water quality.

Interpretive Guidelines §493.1252(b)(1)

Water quality is classified by several different organizations into different reagent grades

dependent on microbial content, resistivity, silicate content, and particulate matter. Each

laboratory is expected to use the appropriate water quality as required for each

instrument, kit, or test system. Laboratories producing water should consider parameters

such as pH, silicate content, particulate matter, and bacterial and organic content in

assessing water quality. These parameters vary by test system. The laboratory should

assess each test system to determine the parameters of water appropriate for that system

and to develop monitoring procedures to ensure the water remains within those

parameters. Laboratories purchasing water that has already been classified are not

expected to evaluate the above parameters unless specified by the manufacturer or by the

laboratory in its procedure manual.

(b)(2) Temperature.

(b)(3) Humidity.

Interpretive Guidelines §493.1252(b)(2)-(b)(3)

Corrective action is needed when acceptable temperature and/or humidity ranges are

exceeded. Use D5781 when corrective action not documented.

Continuous monitoring of temperatures by a recording thermograph or computer is

acceptable provided the data and time of use are annotated or otherwise electronically

recorded. The charts must be retained for at least two years unless otherwise specified to

document that temperatures were within the limits established by the laboratory. Refer to

D3035 for additional information on record retention.

It is also acceptable for temperatures to be maintained and monitored internally by the

instrument, provided (1) test results are either flagged or not generated when the

temperature range for test performance is exceeded, and (2) the laboratory retains the

instrument’s temperature readings for at least two years. If the instrument is not capable

of recording and maintaining its readings, the lab will need to manually record the

readings and retain those records for at least two years to comply with § 493.1105(a)(3)

and § 493.1289.

(b)(4) Protection of equipment and instruments from fluctuations and interruptions

in electrical current that adversely affect patient test results and test reports.

Probes §493.1252(b)(1)-(b)(4)

How does the laboratory provide special conditions when required for specimen or

reagent storage?

How is room temperature and humidity monitored when necessary for test performance,

proper operation of reagents, instruments, equipment, or laboratory computer systems?

When temperatures and/or humidity are outside acceptable limits, how does the

laboratory rectify the problem?

How does a laboratory that moves from testing site to testing site demonstrate that the

conditions necessary for quality testing are maintained?

When mobile laboratory or temporary testing site equipment is not in use (weekends,

overnight) how are instruments, reagents, stains, and other solutions protected from

extreme temperature fluctuations?