CMS SOM App. C, Tag D5769

(e) Transplantation. Laboratories performing histocompatibility testing for

infusion and transplantation purposes must establish and follow written policies and

procedures specifying the histocompatibility testing (that is, HLA typing, antibody

screening and identification, and crossmatching) to be performed for each type of

cell, tissue, or organ to be infused or transplanted. The laboratory's policies and

procedures must include, as applicable—

(e)(1) Testing protocols that address:

Interpretive Guidelines §493.1278(e)(1)

The protocol agreement between the laboratory and the transplant service should include

the recommendation for the collection of a monthly serum specimen on all active wait-listed patients.

If the laboratory provides support to a transfusion service, there should be a policy and

procedure in place that outlines how requests and testing are handled. The laboratory

should be an active participant in the transplant center’s clinical program. It should

provide the technical assistance and pertinent data necessary to help establish transplant

protocols for solid organ, tissue, and cellular transplants and infusions. Each protocol

should define which HLA Class I (A, B, C) and Class II (DR, DQ, DP) loci and

resolution are required and circumstances under which retyping is required. These

policies and procedures should be developed in conjunction with the transplantation

center.

Probes §493.1278(e)(1)

Is there a transplant agreement for the specific transplant protocol?

Does the procedure in use reflect the protocol agreement?

What is the laboratory’s frequency for screening potential transplant recipient sera for

preformed HLA-specific antibodies?

(e)(1)(i) Transplant type (organ, tissue, cell);

Probe §493.1278(e)(1)(i)

What type of transplant services does the laboratory support?

(e)(1)(ii) Donor (living, deceased, or paired): and

Interpretive Guidelines §493.1278(e)(1)(ii)

Laboratories must have processes and protocols in place for each donor type. There may

be different protocols for deceased versus living donors (for example: differences in turn-around times or levels of testing). Paired donor programs may also have specific

requirements, which must also be outlined in the protocol.

(e)(1)(iii) Recipient (high risk vs. unsensitized);

Interpretive Guidelines §493.1278(e)(1)(iii)

Laboratories must have processes and protocols in place that outline the testing based on

the risk status of the recipient.

(e)(2) Type and frequency of testing required to support clinical transplant

protocols; and

Interpretive Guidelines §493.1278(e)(2)

Policies must address the type of testing, frequency of testing and address when testing

and final crossmatches are required for patients who have demonstrated pre-transplant

sensitization.

The laboratory or clinical team should have policies and procedures in place to define

when there is a need for additional recipient specimens for immunological assessment

and the circumstances when the collection of additional recipient specimens is not

needed, such as in pediatric cases.

Probes §493.1278(e)(2)

What are the criteria for determining the type of testing, frequency of testing, and when

testing and final crossmatches are required?

If the laboratory performs a virtual crossmatch, what are the criteria for determining

when a virtual crossmatch can be performed or additional testing is needed?

(e)(3) Process to obtain a recipient specimen, if possible, for crossmatch that is

collected on the day of the transplant. If the laboratory is unable to obtain a

recipient specimen on the day of the transplant, the laboratory must have a process

to document its efforts to obtain the specimen.

Interpretive Guidelines §493.1278(e)(3)

The laboratory must have a policy to obtain a recipient specimen, if possible, for

crossmatch that is collected on the day of transplant. If the laboratory is not able to

obtain the recipient specimen on the day of the transplant, there must be documentation

showing it attempted to obtain the specimen. The laboratory’s attempt to obtain the

specimen does not have to be documented on the day of the transplant and can be

completed after the day of the transplant.