Piedmont Reproductive Endocrinology Group (Preg)

Summary Statement of Deficiencies D3031 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3) Analytic systems records. Retain quality control and patient test records (including instrument printouts, if applicable) and records documenting all analytic systems activities specified in 493.1252 through 493.1289 for at least 2 years. This STANDARD is not met as evidenced by: Based on the review of laboratory records and absence of documentation 11/16/21, the laboratory failed to retain manufacturer's QC(quality control) assay sheets for endocrinology testing for 2 years. Findings: Review of 2019, 2020, and 2021 laboratory QC records for the Tosoh AIA-360 revealed the laboratory failed to retain the BioRad Lyphocheck Immunoassay Plus control assay sheets for the following lot numbers: 1. Lyphocheck Immunoassay Plus Levels 1, 2, and 3 Control lot # 40370, expiration date: 10/31/21 ; 2. Lyphocheck Immunoassay Plus Levels 1, 2, and 3 Control lot# 40380, expiration date: 8/3/22. D5211 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(a) The laboratory must review and evaluate the results obtained on proficiency testing performed as specified in subpart H of this part. This STANDARD is not met as evidenced by: Based on review of the laboratory's PT(Proficiency testing) policy, the review of 2019, 2020, and 2021 AAB(American Association of Bioanalysts) PT records and absence of documentation 11/16/21, the laboratory failed to ensure that all proficiency testing results were evaluated to include

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 review of 2017 and 2018 AAB(American Association of Bioanalysts) Proficiency testing records and interview with TS(Technical Supervisor) 9/9/19, the laboratory failed to ensure attestation statements were signed to document testing of the proficiency samples in the patient workload using the laboratory's routine methods. Findings: Review of 2017 and 2018 AAB proficiency testing records revealed: 1. The laboratory director or designee failed to sign the attestation statements for the following events: a. 2017 S2 event Andrology; b. 2017 Q2 event Chemistry; c. 2017 Q3 event Chemistry; d. 2018 Q1 event Chemistry. During interview at approximately 2:45p.m., the TS stated the attestations had not been signed by previous TS. D5211 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(a) The laboratory must review and evaluate the results obtained on proficiency testing performed as specified in subpart H of this part. This STANDARD is not met as evidenced by: Based on review of laboratory's PT (Proficiency testing) policy, the review of 2018 and 2019 AAB (American Association of Bioanalysts) PT records, and interview with the TS(Technical Supervisor) 9/9/19, the laboratory failed to ensure that all Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- proficiency testing results were evaluated to include