Summary:
Summary Statement of Deficiencies D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The individual testing or examining the samples and the laboratory director must attest to the routine integration of the samples into the patient workload using the laboratory's routine methods. This STANDARD is not met as evidenced by: Based on record review, staff interview, and policy review, the testing personnel and laboratory director failed to sign the attestation statements for 2 of 4 (3-2022 and 1- 2023) hematology proficiency testing events reviewed. Findings include: 1. Reviewed at 9:20 a.m. on 07/10/23, the 2022-2023 hematology proficiency testing records showed the following: - Event 3-2022 the testing personnel and laboratory director failed to sign the proficiency testing attestation statement - Event 1-2023 the testing personnel failed to sign the proficiency testing attestation statement. 2. During interview at 9:50 a.m. on 07/10/23, the laboratory director (#1) confirmed the testing personnel and laboratory director had not signed the attestation statement for 3-2022 and the testing personnel had not signed the attestation statement for 1-2023. 3. Reviewed on 07/10/23, the policy "Quality Control/Proficiency Testing," dated 02/12 /93, stated, ". . . The laboratory will participate in an approved Proficiency Testing program . . . *The Testing personnel must also sign the Attestation Statement. . . . *The Lab Director must also sign off on the Attestation Statement. . . ." 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 --