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 and staff interview, the laboratory director or designee failed to sign the attestation statements for 2 of 4 (2-2021 and 3-2021) chemistry proficiency testing events reviewed. Findings include: 1. Reviewed at 8:25 a.m. on 07/07/22, the 2021-2022 proficiency testing records lacked evidence the laboratory director or designee signed the proficiency testing attestation statements for 2-2021 and 3-2021 chemistry proficiency testing events. 2. During interview at 12:30 p.m. on 07/07/22, the laboratory supervisor (Personnel #1) confirmed the laboratory director or designee had not signed the attestation statements for 2-2021 and 3-2021 chemistry proficiency testing events. 3. Upon request at 1:30 p.m. on 07/07/22, the laboratory failed to provide a policy regarding the signing of proficiency testing attestation statements. 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 --