Summary:
Summary Statement of Deficiencies D0000 An announced validation survey was performed on 05/02/2023. Noted deficiencies and plans of correction were discussed with the laboratory representative(s) at the exit conference. D1001 CERTIFICATE OF WAIVER TESTS CFR(s): 493.15(e) Laboratories eligible for a certificate of waiver must-- (1) Follow manufacturers' instructions for performing the test; and (2) Meet the requirements in subpart B, Certificate of Waiver, of this part. This STANDARD is not met as evidenced by: Based on review of the Instructions for Use for the BinaxNOW RSV card, a review of patient test records from October 2022 to January 2023, and staff interview, it was revealed that the laboratory failed to follow the manufacturer's instructions by ensuring the BinaxNOW RSV (Respiratory Syncytial Virus) test was run on patients five years of age or older for three of twelve patient test reports reviewed. Findings include: 1. A review of the Instructions for Use for the BinaxNOW RSV card test revealed the following: "ATTENTION Do not use the RSV test in patients 5 years or older." 2. A review of the laboratory's patient test records from October 2022 to January 2023 revealed the following 3 patient's samples were run using the BinaxNOW RSV card: Patient MRN: 157259 Patient date of birth: 11/11/91 Patient age: 30 years Date tested: 10/4/22 Patient MRN: 159099 Patient date of birth: 6/6/71 Patient age: 51 years Date tested: 1/10/23 Patient MRN: 159370 Patient date of birth: 12/13/2004 Patient age: 18 years Date tested: 1/26/23 3. An interview with the facility administrator on 5/2/23 at 12:40 p.m. in the break room, after review of the records, confirmed the above findings. D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 7 -- 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)