Summary:
Summary Statement of Deficiencies D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: Based on observation of the laboratory, review of patient test records, lack of documentation, and interview with the laboratory supervisor, the laboratory failed to verify the accuracy of the Atago PAL-10S digital refractometer in 2021 and 2022. The findings include: 1. Observation of the laboratory on 10/14/22 at 9:15 am revealed the non-waived Atago PAL-10S refractometer in use for confirming urine specific gravity results that were performed on the Clinitek Status waived urine dipstick. 2. Review of patient test records revealed the specific gravity from the refractometer is reported when used for confirmatory purposes--patient specimen numbers reviewed included: AL073284A-collected 01/19/2021, AL558255J-collected 09/29/2021, and AL398391W collected 09.26.22. 3. No documents were present for verifying the accuracy of the specific gravity results for the Atago digital refractometer in 2021 and 2022. 4. Interview with the laboratory supervisor on 10/14/22 at 1:30 pm confirmed the laboratory failed to verify the accuracy of the Atago PAL-10S digital refractometer in 2021 and 2022. 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 --