Ciocca Dermatology Pa

Summary Statement of Deficiencies D0000 A recertification survey was conducted on March 15, 2022. Ciocca Dermatology PA clinical laboratory was in not compliance with 42 CFR 493, requirements for clinical laboratories. 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 record review and interview, the laboratory failed to retain quality control documents from 03/15/2020 to 02/28/2022 Findings: Review of the laboratory's quality control documents revealed the laboratory only had the "Laboratory Reagent Log" for March 2022. On 03/15/2022 at 3:03 PM, the Mohs Technician stated the reagent log is created each month, and that she thinks the other months logs were thrown away in the trash. 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 interview, the laboratory failed to verify accuracy of the reading and interpretation of the Dermatophyte Testing Media (DTM) at least twice annually in 2020 and 2021 for one (B) of two (A,B) testing personnel. Findings: The 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 -- laboratory performs proficiency testing (PT) using Wisconsin State Laboratory of Hygiene (WSLH) PT for their DTM testing. Review of the WSLH PT records for the 1st, 2nd and 3rd in 2020, and the 1st, 2nd and 3rd in 2020 showed they were all performed by Testing Personnel A On 03/15/2022 at 2:00 PM, the Office Manager acknowledged the proficiency testing was not performed by Testing Personnel B. -- 2 of 2 --

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 of Wisconsin State Laboratory of Hygiene Proficiency Testing (WSLH PT) and interview with laboratory personnel, the laboratory did not verify the accuracy of fungal cultures twice annually. Findings include: Review of 2 years of WSLH PT revealed that the laboratory failed to submit results for the first event of 2018. During an interview on 6/25/2018 at 10:30 AM, the Office Manager confirmed that the laboratory failed to submit the results for the event of reference. 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 --