CMS SOM App. C, Tag D5559

(e) Investigation of transfusion reactions.

(e)(1) According to its established procedures, the laboratory that performs

compatibility testing, or issues blood or blood products, must promptly investigate

all transfusion reactions occurring in facilities for which it has investigational

responsibility and make recommendations to the medical staff regarding

improvements in transfusion procedures.

(e)(2) The laboratory must document, as applicable, that all necessary remedial

actions are taken to prevent recurrences of transfusion reactions and that all

policies and procedures are reviewed to assure they are adequate to ensure the

safety of individuals being transfused.

Interpretive Guidelines §493.1271(e)(2):

Transfusion Related Fatalities must be reported to Federal and State authorities as

specified in 21 CFR §606.170(b) and 42 CFR §493.1103(d).

Examine records of transfusion reaction investigations for completeness, accuracy, and

promptness. Verify that investigations of transfusion reactions are conducted in

accordance with the facility’s established protocols. Records must include each step of

the investigation, including conclusions and any follow-up.

Probes §493.1271(e)(2):

Did the laboratory report Transfusion Related Fatalities to the applicable authorities? Cite

at D3025.

If problems or technical errors are identified during a transfusion reaction investigation,

are corrective actions taken and, as applicable, procedures instituted to prevent a

recurrence?

Did the laboratory assess the adequacy of the procedures implemented? Use D5793.

§493.1271 Standard: Immunohematology.

(f) Documentation. The laboratory must document all control procedures

performed, as specified in this section.

Interpretive Guidelines §493.1271(f)

All non-transfusion related immunohematology QC records must be retained for at least 2

years. Use D3035.

Transfusion-related immunohematology QC records, including but not limited to, donor

processing, compatibility testing, and transfusion reaction investigations, must be

retained for the timeframe stated at 21 CFR §606.160(d).