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 record review and interviews with the Office Manager and Head Nurse, the laboratory failed to follow policies and procedures to verify the accuracy of the potassium hydroxide (KOH) and scabies testing, at least twice annually for 4 out of 4 Testing Personnel (TP). All patients tested in the subspecialties of mycology and parasitology had the potential to be affected. Findings include: 1. Review of the laboratory's 'Scabies and KOH Testing Policy and Procedure,' found the following statement:"...Providers performing microscopic testing are assessed semi-annually to assess...test accuracy verification..." 2. Review of the laboratory's KOH and scabies test accuracy verification documentation found that the laboratory failed to follow policies and procedures to assess 4 out of 4 Testing Personnel (TP) for test accuracy verification (TAV) of the KOH and scabies test on a semi-annual basis. TP #3: 2020 Dates: None 2019 Dates: 01/03/2019 2018 Dates: 05/17/2018, 12/28/2018 TP #4: 2020 Dates: None 2019 Dates: 03/19/2019 2018 Dates: 09/07/2018 TP #5: 2020 Dates: None 2019 Dates: 09/07/2018 2018 Dates: 01/03/2018, 10/01/2018 TP #6: 2020 Dates: None 2019 Dates: 02/11/2019, 01/28/19 2018 Dates: 08/03/18 3. An interview with the Office Manager and Head Nurse, on 11/09/2020 at 12:58 PM, confirmed that the laboratory failed to follow their own policy of assessing the providers semi-annually for TAV of the KOH and scabies tests. D5431 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(2) For unmodified manufacturer's equipment, instruments, or test systems, 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 4 -- must perform and document function checks as defined by the manufacturer and with at least the frequency specified by the manufacturer. Function checks must be within the manufacturer's established limits before patient testing is conducted. This STANDARD is not met as evidenced by: Based on record review, and interviews with the Office Manager and the Head Nurse, the laboratory failed to follow their policy and procedure, and document microscope cleaning and/or maintenance after 08/18/2020. Nine out of 9 patients tested tested for fungal organisms using the KOH reagent, from 08/19/2020 through 11/09/2020 had the potential to be affected. Findings Include: 1. Review of the laboratory's 'Microscope Maintenance' policy and procedure, on 11/09/2020 at 1:46 PM, found the following statements: "...Procedure: Daily: - Eyepieces and objectives will be cleaned with lens paper or lens cleaner. - Clean stage with lens paper. Remove residual coverslip medium that may accumulate on the stage. - Routine maintenance, problems and