CMS SOM App. C, Tag D5787

(a) The laboratory must maintain an information or record system that includes the

following:

(a)(1) The positive identification of the specimen.

(a)(2) The date and time of specimen receipt into the laboratory.

(a)(3) The condition and disposition of specimens that do not meet the laboratory’s

criteria for specimen acceptability.

(a)(4) The records and dates of all specimen testing, including the identity of the

personnel who performed the test(s).

Interpretive Guidelines §493.1283(a)

The regulations provide laboratories the flexibility to establish a system that ensures

positive patient identification through specimen accessioning and storage, testing and

reporting of test results. This may include a system that involves labeling the specimen

container and request slip or the patient’s medical record or chart with a unique patient

identification number, but does not preclude the use of other mechanisms to assist in

patient identification and tracking of specimens throughout the testing and reporting

processes. The patient’s name may be used as part of the identification system.

Ensure that work records reflect all the tests and dates of performance of in-house patient

testing. For example, in bacteriology, each step from media inoculation to organism

isolation and identification must be documented on worksheet records either manually or

in a computer system.

Corrections of laboratory results should include the corrected result, incorrect result

(noted as such), the date of the correction, and the initials of the person making the

correction.

Laboratory records should not be documented in pencil and the use of whiteout is not

acceptable for making corrections.

Probes §493.1283(a)

Do the records reflect all patient testing and the dates of their performance?

If handwritten values were reported, can the laboratory demonstrate the analytic source of

those results?

If the laboratory has not retained the appropriate test records, cite D3031, D3033, or

D3035.