Summary:
Summary Statement of Deficiencies D5553 IMMUNOHEMATOLOGY CFR(s): 493.1271(b)(f) (b) Immunohematological testing and distribution of blood and blood products. Blood and blood product testing and distribution must comply with 21 CFR 606.100(b)(12); 606.160(b)(3)(ii) and (b)(3)(v); 610.40; 640.5(a), (b), (c), and (e); and 640.11(b). (f) Documentation. The laboratory must document all control procedures performed, as specified in this section. This STANDARD is not met as evidenced by: A Revisit survey was performed at New Orleans East Hospital-CLIA ID # 19D2074804 on October 29, 2019 through October 30, 2019. Based on record review and interview with personnel, the laboratory failed to follow their emergency release policy for blood. Findings: 1. Review of the laboratory's policy for emergency release of blood revealed "immediately perform Type, Screen and Compatibility testing and notify physician or nurse at first sign of incompatibility." 2. Review of the laboratory's emergency release and blood bank records revealed the following patient was issued two (2) units of blood without follow up compatibility testing: June 8, 2019 at 19:43: Patient 1003062772 3. In interview on October 30, 2019 Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --