CMS SOM App. C, Tag D3001

(a) The laboratory must be constructed, arranged, and maintained to ensure the

following:

(a)(1) The space, ventilation, and utilities necessary for conducting all phases of the

testing process.

Interpretive Guidelines §493.1101(a)(1)

Work areas should be arranged to minimize problems in specimen handling, examination

and testing, and the reporting of test results.

Workbench space should be sufficient for test performance, well lit, and have water, gas,

suction, and electrical outlets as necessary. Instruments, equipment, and computer

systems should be placed in locations where their operation is not affected adversely by

physical or chemical factors, such as heat, direct sunlight, vibrations, power fluctuations

or fumes from acid or alkaline solutions. Equipment tops should not be used as

workbench space.

Determination of proper lighting is subjective since the regulations do not specify the

foot-candles or other measures of light intensity required. Ensure that lighting or

background is appropriate for visual interpretation of test results (e.g., macroscopic

evaluation of hemagglutination reactions or strep screen; dark background with reflected

light for reading K-B disk diffusion AST). When citing deficiencies, document the

circumstances in which lighting adversely or may adversely affect test performance or

personnel safety.

Determine that the laboratory has a system to ensure its ventilation system properly

removes vapors, fumes, and excessive heat, when appropriate, for the type of testing done

in the laboratory.

Ensure that an adequate, stable electrical source is maintained at each location (e.g.

outlets, not extension cords) and meets the power requirements for each piece of

equipment.