Summary:
Summary Statement of Deficiencies D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: Based on review of proficiency records for 2022 to date April 10, 2024, interview with technical consultant (TC), the laboratory failed to establish a means to verify the accuracy of the non-regulated analyte, manual differential twice yearly. Findings: 1. Review of proficiency records for 2022 to date April 10, 2024 showed the laboratory failed to prove accuracy on the non-regulated analyte: manual differential. 2. Interview with the TC on April 10, 2024 at 10:30 AM confirmed the laboratory failed to verify the accuracy of the non-regulated analyte manual differential twice annually. D5473 CONTROL PROCEDURES CFR(s): 493.1256(e)(2)(g) (e) For reagent, media, and supply checks, the laboratory must do the following: (e) (2) Each day of use (unless otherwise specified in this subpart), test staining materials for intended reactivity to ensure predictable staining characteristics. Control materials for both positive and negative reactivity must be included, as appropriate. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on lack of hematology records and interview with the technical consultant (TC), the laboratory failed to document the quality of staining materials each day of use for manual differentials for 2022 and to date March 10, 2024. Findings: 1. Lack of hematology records showed the laboratory failed to document the quality of staining Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- materials each day of use for manual differentials in 2022 and to date March 10, 2024. 2. Interview with TC on March 10, 2024 at 10:30 AM confirmed the laboratory failed to document the quality of the manual differential stain each day of use. -- 2 of 2 --