CMS SOM App. C, Tag D5765

(d)(2) Have available and follow written criteria for the following:

(d)(2)(i) Defining donor and recipient HLA antigens, alleles, and antibodies to be

tested;

(d)(2)(ii) Defining the criteria necessary to assess a recipient’s alloantibody status;

Probe §493.1278(d)(2)(ii)

What criteria does the laboratory use to determine the recipient's sensitization history and

current alloantibody status? Examples include, but are not limited to, prior transplants or

transfusions, and pregnancy status.

(d)(2)(iii) Assessing recipient antibody presence or absence on an ongoing basis;

Probe §493.1278(d)(2)(iii)

When additional information is critical for the interpretation of test results, how does the

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

example, if the laboratory reports the mean fluorescence intensity (MFI), have they

included an interpretation that allows the transplant service clinician to determine if a

transplant is contraindicated?

If pertinent information is missing, cite at D5805.

(d)(2)(iv) Typing the donor, to include those HLA antigens to which antibodies have

been identified in the potential recipient, as applicable;

Interpretive Guidelines §493.1278(d)(2)(iv)

Laboratories that use different methods to type donors and/or recipients should assess

compatibility between donors and recipients, as needed based on the typing method used.

For example, compatibility of a donor typed at the serological level should be determined

for a recipient with antibodies that have been identified at the allele level.

(d)(2)(v) Describing the circumstances in which pre- and post-transplant

confirmation testing of donor and recipient specimens is required;

(d)(2)(vi) Making available all applicable donor and recipient test results to the

transplant team;

Probe §493.1278(d)(2)(vi)

When additional information is critical for the interpretation of test results, how does the

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

pertinent information is missing, cite at D5805. Example: If the laboratory reports MFI

(Mean Fluorescence Intensity) value, have they included an interpretation?

(d)(2)(vii) Ensuring immunologic assessments are based on test results obtained

from a test report from a CLIA-certified laboratory; and

Probe §493.1278(d)(2)(vii)

How does the laboratory ensure that testing is performed by a CLIA-certified laboratory?

(d)(2)(viii) Defining time limits between recipient testing and the performance of a

crossmatch.

Probe §493.1278(d)(2)(viii)

What are the criteria for defining time limits between recipient testing and the

performance of a crossmatch?