Suncoast Skin Solutions Inc

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at Suncoast Dermatology and Skin Surgery Center PA on 07/14/22. The laboratory is not in compliance with 42 CFR Part 493, Requirements for Laboratories. The following is a description of the standard level deficiencies: D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) The laboratory must define criteria for those conditions that are essential for proper storage of reagents and specimens, accurate and reliable test system operation, and test result reporting. The criteria must be consistent with the manufacturer's instructions, if provided. These conditions must be monitored and documented and, if applicable, include the following: (1) Water quality. (2) Temperature. (3) Humidity. (4) Protection of equipment and instruments from fluctuations and interruptions in electrical current that adversely affect patient test results and test reports. This STANDARD is not met as evidenced by: Based on record review and interview with the MOHS Technician , the laboratory failed to record the room humidity every day that testing was performed (475 days) from 4/20/2020 to the day of survey, 07/14/2022. Findings Included: Review of the Leica cryostat instrument manual revealed that the maximum room humidity should be 60%. Review of the laboratory's Reagent Filtering/Disposal?Quality & Temperature Logs from April 2020 to July 2022 revealed no column to record humidity. On 7/15/22 at 12:30 PM., the MOHS Technician stated she did not know the laboratory was supposed to be documenting room humidity. 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 --

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at Suncoast Dermatology and Skin Surgery Center PA on 04/16/2020. The laboratory is not in compliance with 42 CFR Part 493, Requirements for Laboratories. The following is a description of the standard level 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 interview with the Medical Assistant, the laboratory failed to evaluate the accuracy of the subspecialty of Parasitology testing for Wet Mount testing for Scabies and the subspecialty of Mycology Potassium Hydroxide (KOH) testing for fungi at least twice a year for 2 (2018 and 2019) out of 2 years reviewed for 7 (B, C, D, E, F, G, and H) out of 7 testing personnel. Findings Included: Review of the CMS 209, Laboratory Personnel Report, signed by the Laboratory Director on 3/14/20, revealed 7 Testing Personnel (B, C, D, E, F, G, and H) for moderate complexity. Record review of the "Proficiency Testing" form for Wet Mount and KOH testing revealed that the Proficiency Testing would be performed every 6 months . The following results were found: Testing Personnel B had performed one (10/17/19) Wet mount proficiency testing out of the every 6 months proficiency testing for 2019. Testing Personnel C had not performed Wet Mount or KOH proficiency testing every 6 months for 2 out of 2 years (2018 and 2019). Testing Personnel D had not performed Wet Mount proficiency testing every 6 month for 2 out of 2 years (2018 and 2019) and had performed KOH proficiency testing every 6 month for 1 (11/13/2018) out of 2 years (2018 and 2019). Testing Personnel E had performed KOH proficiency testing every 6 months for 1 (2018) out of 2 years (2018 and 2019). Testing Personnel F had not performed Wet Mount proficiency testing 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 -- every 6 months for 2 out of 2 years (2018 and 2019). Testing Personnel G had not performed KOH proficiency testing every 6 months for 2018 and had performed one (1/17/2019) KOH proficiency testing out of the every 6 months for 2019. Additionally, Testing Personnel G had not performed Wet Mount proficiency testing every 6 months for 1 (2019) out of 2 years (2018 and 2019). Testing Personnel H had not performed Wet Mount proficiency testing every 6 months for 1 of 1 year (2019). Interview on 04/16/20 at 12:20 PM with the Medical Assistant/Moh's Technician confirmed that no other peer reviews were available for review. She also stated the laboratory did not know how to perform the proficiency testing without patient samples. -- 2 of 2 --