CMS SOM App. C, Tag D5805

(c) The test report must indicate the following:

(c)(1) For positive patient identification, either the patient’s name and identification

number, or a unique patient identifier and identification number.

Interpretive Guidelines §493.1291(c)(1) - (c)(6)

Use D5203 for deficiencies related to specimen identification problems.

When used on the test report, the patient’s name must be accompanied by an

identification or accession number. When for confidentiality purposes a patient’s name is

not used or when the identity of the person is not known, a unique patient identifier and

identification or accession number must be used on the report.

(c)(2) The name and address of the laboratory location where the test was

performed.

Interpretive Guidelines §493.1291(c)(2)

Laboratories having a single certificate for multiple sites/locations must have a system in

place to identify which tests were performed at each site. When testing is performed in

more than one location in a hospital, the specific location in the hospital must be stated

on the laboratory report (for example, ER, NICU, etc.)

A code to identify the name and address of the laboratory performing testing is

acceptable as long as the code is clearly annotated on the patient test report. This may be

accomplished by using abbreviated indicators (e.g., asterisks) as long as they are

identified and apparent to the individual receiving the report. This or a similar system

may be seen on cumulative reports. The name and address of the reference laboratory

may also be defined on a subsequent page or on the back of the report. Laboratories have

latitude to develop other formats to meet this requirement.

§493.1291 Standard: Test report.

(c)(3) The test report date.

Interpretive Guidelines §493.1291(c)(3)

The date of the test report is the date results were generated as a final report and must not

change on copies or electronic reports generated at a later date.

If a preliminary result is generated, it should be clearly labeled and include the date of the

preliminary report, to differentiate it from the final test result in the final report or in the

electronic reporting system.

If a laboratory test order contains multiple tests and these tests are completed on different

days, the report should show when each test was completed.

Example:

An order for CBC, CMP and HIV is received in the lab and completed on

8/14/23, each test must show 8/14/23 as test report date.

On the other hand, if the CBC and CMP were completed on 8/14/23, but the

HIV was completed on 8/15/23, the report date must be as follows:

CBC: 8/14/23

CMP: 8/14/23

HIV: 8/15/23

(c)(4) The test performed.

Interpretive Guidelines §493.1291(c)(4)

The laboratory must establish performance specifications in accordance with

§493.1253(b)(2), and must make them available to clients in accordance with

§493.1291(e).

(c)(5) Specimen source, when appropriate.

Interpretive Guidelines §493.1291(c)(5)

Some examples of source of the specimen needed by the laboratory to accurately perform

testing and report results would be: type of body fluid; whether a submitted separated

specimen is plasma, serum, urine, etc.

§493.1291 Standard: Test report.

(c)(6) The test result and, if applicable, the units of measurement or interpretation,

or both.

Interpretive Guidelines §493.1291(c)(6)

If the laboratory prints normal ranges on the patient test report, verify that appropriate

normal ranges (e.g., age specific) are printed by the LIS on the patient test report.

“Less than” is used for reporting test results (qualitative or quantitative) that are below

the laboratory’s detection limits for an analyte. (Detection limits must be established

through method verification as described in §493.1253.)

“Equivalent designation” is used to report test results for those methods that yield results

below a clinically significant level (e.g., for a quantitative immunology test, patient

results may be clinically negative at a 1:8 titer and test results may be reported as “1:8

negative”. The normal range is 1:8 or less.)

“Greater than” is used for reporting test results (qualitative or quantitative) that are above

the laboratory’s detection limits for an analyte. If patient test results exceed the

laboratory’s reportable range, the laboratory must report the result as greater than the

highest detection limit, reassay a diluted patient specimen and report the calculated result,

or send the specimen to a reference laboratory.

For flow cytometry, to interpret results, staff should have access to the complementary

clinical picture of the patient. This may include such results as white cell count, cell

differential, cell morphology, and cytogenetics.

Flow cytometry patient data files should include any gating analysis regions used to

obtain reported test results.

For genetic tests, the laboratory should include the test method(s) employed, any variants

that were detected, and any additional information that may affect the interpretation of

the test results, such as software or program names and versions that assist in the analysis

and interpretation of the genetic data, if applicable, on the test report.

Probes §493.1291(c)(6)

When additional information is critical for the interpretation of test results (e.g.,

screening vs. confirmatory procedures, interpretation software), how does the laboratory

convey this information to the individual ordering or using test results?

If the laboratory does not print normal ranges on the test report, how does the laboratory

notify the client that reported results are abnormal for the patient due to their particular

sex and/or age?

How does the laboratory convey updates to the analysis and interpretation software to the

individual ordering or using the test results?

§493.1291 Standard: Test report.

(c)(7) Any information regarding the condition and disposition of specimens that do

not meet the laboratory’s criteria for acceptability.

Interpretive Guidelines §493.1291(c)(7)

If the laboratory functions as a reference laboratory, how does it notify the referring

laboratory or client of unacceptable specimens in a timely manner? Use D5801 to cite

timeliness deficiencies. Use D5805 to cite the referring laboratory’s failure to notify the

appropriate individual concerning the unacceptable specimen.