Summary:
Summary Statement of Deficiencies D0000 The Dawson County Hospital District laboratory was found to be in compliance with 42 CFR Part 493, Requirements for Laboratories as a result of a validation survey conducted on September 11, 2024. D5449 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(ii)(g) Unless CMS Approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing, the laboratory must-- At least once a day patient specimens are assayed or examined perform the following for-- Each qualitative procedure, include a negative and positive control material; (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on review of laboratory policy, quality control records, and interview with laboratory personnel, the laboratory failed to run a negative control each day of patient testing for the Anti-A and Anti-B antisera for determing blood types for 12 of 12 days reviewed between June 24, 2024 and July 6, 2024. The findings included: 1. Based on review of the laboratory policy "Quality Control Procedures", number 21, the laboratory's quality control chart indicated the following: Reagent under Test - Anti-A antisera QC Reagent: corQC reagent cells Expected results: 2-4 plus at immediate spin Reagent under Test - Anti-B antisera QC Reagent: corQC reagent cells Expected results: 2-4 plus at immediate spin 2. Based on reivew of the blood bank quality control logs between June 24, 2024 and July 6, 2024, quality control was performed on 12 days. On all twelve days, the Anti-A and Anti-B antisera were not checked with a negative control. 3. In an interview on 9/11/2024 at 14:33 hours in the conference room, both the Laboratory Manager and the Laboratory Director confirmed the laboratory's quality control practice for blood bank anti-sera did not include testing a negative control. 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 --