Summary:
Summary Statement of Deficiencies D5551 IMMUNOHEMATOLOGY CFR(s): 493.1271(a)(f) (a) Patient testing. (a)(1) The laboratory must perform ABO grouping, D (Rho) typing, unexpected antibody detection, antibody identification, and compatibility testing by following the manufacturer's instructions, if provided, and as applicable, 21 CFR 606.151(a) through (e). (a)(2) The laboratory must determine ABO group by concurrently testing unknown red cells with, at a minimum, anti-A and anti-B grouping reagents. For confirmation of ABO group, the unknown serum must be tested with known A1 and B red cells. (a)(3) The laboratory must determine the D (Rho) type by testing unknown red cells with anti-D (anti-Rho) blood typing reagent. (f) Documentation. The laboratory must document all control procedures performed, as specified in this section. This STANDARD is not met as evidenced by: Based on review of patient worksheets for blood bank, quality control (QC) records and and interview with the general supervisor on 5/15/2018 at 11:40 AM, the laboratory failed to document daily QC recordings for 2 of 12 days of patient testing. Findings are: 1. Review of blood bank patient worksheets revealed patient testing occurred on 12 days between 1/22/2018 and 5/9/2018. 2. Review of blood bank QC records for this time period revealed QC recordings for only 10 of the 12 testing days. No documentation of QC could be presented at the time of survey for 4/21/2018 and 4 /30/2018. Worksheets indicated type and screens and crossmatches had been performed on both days. 3. During interview, the general supervisor stated the controls had been performed on these 2 days and the worksheets initialed, but the results had not been documented in the QC records. 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 --