Summary:
Summary Statement of Deficiencies D0000 The validation survey was performed on 05/28/2026. Standard-level deficiencies were cited. D1001 CERTIFICATE OF WAIVER TESTS CFR(s): 493.15(e) 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 a review of records, observation, and interview with testing person #1, the laboratory failed to follow manufacturer's instructions to ensure one of one borrle of True Metrix Pro glucose test strips had not exceeded their open vial expiration dates. Findings include: (1) On 05/28/2026 at 12:30 pm, testing person #1 stated glucose testing was performed on the True Metrix Pro Glucometer; (2) Observation of the laboratory on 05/28/2026 at 12:30 pm identified one open bottle (Lot #, Z65992S expiration 08/31/2026) of True Metrix Pro test strips stored at room temperature, without documentation of when they were put in use; (3) Review of the manufacturer's package insert stated the following: (a) "Write date opened on test strip vial label when removing the first test strip. Discard all unused test strips in vial after either date printed next to EXP on the test strip vial label or 4 months after date opened". (4) Interview with testing person #1 on 05/28/2026 at 12:30 pm confirmed the bottle had been opened without a method to monitor if they exceeded the manufacturer's modified expiration date. D5807 TEST REPORT CFR(s): 493.1291(d) (d) Pertinent "reference intervals" or "normal" values, as determined by the laboratory Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- performing the tests, must be available to the authorized person who ordered the tests and, if applicable, the individual responsible for using the test results. This STANDARD is not met as evidenced by: Based on a review of records and interview with testing person #1, the laboratory failed to ensure reference intervals were determined as appropriate for the laboratory's patient population for two of two patient reports reviewed. Findings include: (1) On 05 /28/2026 at 01:30 pm, testing person #1 stated the laboratory performed complete blood count (CBC) testing using the Medonic M-series analyzer; (2) On 05/28/2026 two patient CBC reports were reviewed - the first report was for an adult female patient with the testing performed on 01/18/2026 at 02:47 pm; the second report was for an adult male patient with the testing performed on 01/23/2026 at 10:06 am. Both reports included the same reference intervals for the following CBC parameters: (a) Hemoglobin - 12.0 - 18.0 g/dL; (b) Hematocrit - 37.0 - 52.0 %. (3) The reports were reviewed with testing person #1 who stated on 05/28/2026 at 01:30 pm, the patient reports did not include gender specific reference ranges for hemoglobin and hematocrit. -- 2 of 2 --