Summary:
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 Patient Test Audits, Quality Control records and interview with the Technical Consultant, determined the Laboratory failed to save Quality Control records and maintenance records for May and August of 2021 for the Complete Blood Count (CBC) Analyzer for the required two years. The findings include: 1. A review of Patient Test Audits for May and August of 2021 revealed no Quality Control records for the CBC analyzer had been retained. 2. A review of Patient Test Audits for May and August of 2021 revealed no maintenance records for the CBC analyzer had been retained. 3. An interview with the Technical Consultant at approximately 11:30 a.m. on November 8, 2021 confirmed the CBC Quality Control records and maintenance records for May and August of 2021 were not retained for the required two year period. ================================= 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 --