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 lack of test kit records, the COVID-19 IgG/IgM Rapid Test Cassette manufacturer's package insert, and interview with the laboratory personnel identifier #1 (refer to the Laboratory Personnel Report) at approximately 2:00 pm on 9/30/2020, the laboratory failed to retain records of the lot number and expiration dates for 25 out of 26 boxes of COVID-19 IgG/IgM Rapid Test Cassettes. The findings include: 1. The laboratory began performing patient testing on 6/8/2020 using the COVID-19 IgG /IgM Rapid Test Cassette manufactured by Zhejiang Orient Gene Biotech Co, LTD. 2. From 6/8/2020 - 9/30/2020 the laboratory performed testing on 635 patients using the COVID-19 IgG/IgM Rapid Test Cassette test system. 3. The manufacturer's package insert stated that each box contained 25 sealed pouches (each containing a test cassette, dropper, and desiccant.) 4. The laboratory used 26 boxes of test kits to perform testing on 635 patients. 5. The laboratory only had the lot number and expiration date for the current box of test kit (lot 2004158). D5014 GENERAL IMMUNOLOGY CFR(s): 493.1208 If the laboratory provides services in the subspecialty of General immunology, the laboratory must meet the requirements specified in 493.1230 through 493.1256, and 493.1281 through 493.1299. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 6 -- This CONDITION is not met as evidenced by: Based on observations made during the survey, review of the COVID-19 IgG/IgM Rapid Test Cassette manufacturer's package insert, lack of quality control and temperature records, patient test records, and interview with laboratory personnel identifier #1 (refer to the Laboratory Test Report), the laboratory failed to meet the general immunology requirements for: establishing procedures as specified in D5403; ensuring the procedure manual is approved, signed, and dated by the laboratory director as specified in D5047; documenting temperatures as specified in D5413; establishing performance specifications as specified in D5423; performing positive and negative quality controls as specified in D5449; ensuring test reports meet requirements as specified in D5805. D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) The procedure manual must include the following when applicable to the test procedure: (1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (2) Microscopic examination, including the detection of inadequately prepared slides. (3) Step-by-step performance of the procedure, including test calculations and interpretation of results. (4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (5) Calibration and calibration verification procedures. (6) The reportable range for test results for the test system as established or verified in 493.1253. (7) Control procedures. (8)