CMS SOM App. C, Tag D5729

HLA (Human Leukocyte Antigens) typing is the identification of histocompatibility

antigens and/or alleles. When condition-level deficiencies in Histocompatibility are

identified in any or all phases of testing, cite D5042.

(a) General. The laboratory must meet the following requirements:

(a)(1) Use a continuous monitoring system and alert system to monitor the storage

temperature of specimens (donor and recipient) and reagents and notify laboratory

personnel when temperature limits are exceeded.

Interpretive Guidelines §493.1278(a)(1)

Verify that the laboratory has a continuous monitoring and alert system for freezers and

refrigerators where patient specimens and reagents are stored. Storage conditions should

ensure the integrity of recipient and donor specimens and reagents is preserved. The

laboratory should establish the temperature at which the system will activate. Liquid

Nitrogen (LN2) reservoirs should be monitored to always ensure adequate supply of

LN2.

Examples of "continuous monitoring" include electronic notification systems, which may

not be physically located at the primary site, or a manual process that will detect when

temperature limits are exceeded.

Under this requirement, laboratories should have a backup method for continuous

monitoring and alert systems, such as an alternate monitoring system. An emergency

power source for the continuous monitoring alarm system in the event of an electrical

failure is one means of ensuring continuous monitoring of temperatures. If emergency

power is not available, the laboratory should have policies/procedures on how to ensure

continuous monitoring using an alternate method to ensure a prompt response to out-of-

range temperatures, 24 hours a day, 7 days a week, including holidays. An acceptable

practice for laboratories that are not staffed 24 hours would include the use of a

notification system.

Verify that the laboratory has an emergency plan for alternate storage appropriate for its

operational needs. Continuous monitoring of temperatures by a recording thermograph is

acceptable, provided the data and time of use are annotated.

Probes §493.1278(a)(1)

Is there evidence of a process to ensure notification of alerts when the limits are

exceeded?

How does the laboratory monitor the level of LN2? How does the laboratory respond to

alerts when limits are exceeded?

Does the laboratory have a policy that outlines alternate storage of specimens and

reagents when storage temperatures are exceeded?

Does the laboratory have an emergency plan to address widespread failures, such as

electrical outages, that may affect storage conditions and continuous monitoring systems

and specimen and reagent integrity?