Regional Dermatology

Summary Statement of Deficiencies D0000 A Recertification Survey was initiated on 09/25/2025 and concluded on 09/25/2025. The facility was found not to be in compliance with the laboratory requirements of 42 CFR Part 493 with deficiencies cited. D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) (b)(1) The individual testing or examining the samples and the laboratory director must attest to the routine integration of the samples into the patient workload using the laboratory's routine methods. This STANDARD is not met as evidenced by: Based on document review and interview, the laboratory failed to ensure the Laboratory Director (LD) and testing personnel signed a proficiency testing (PT) attestation statement for 5 of 6 PT events reviewed. Findings included: A review of an American Proficiency Testing Institute (API) document titled "2023 Microbiology 2nd Event Attestation Statement" indicated, "An attestation statement must be signed by testing personnel and the laboratory director and retained for a minimum of 2 years." A review of the following API Attestation Statements revealed they were not signed by the LD or the person(s) who performed the test: -API 2024 Microbiology 1st Event -API 2024 Microbiology 2nd Event -API 2024 Microbiology 3rd Event - API 2025 Microbiology 1st Event -API 2025 Microbiology 2nd Event During an interview on 09/25/2025 at 1:30 PM, the LD confirmed the above findings. D5211 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(a) The laboratory must review and evaluate the results obtained on proficiency testing performed as specified in subpart H of this part. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- This STANDARD is not met as evidenced by: Based on document review and interview, the laboratory failed to document the review and evaluation of proficiency testing (PT) results for potassium hydroxide (KOH) preparation (glass slide) for 6 of 6 PT events reviewed. Findings included: A review of an American Proficiency Testing Institute (API) document titled "2023 Microbiology 2nd Event Proficiency Testing Performance Evaluation" indicated, "Laboratories should review the Performance Summary and Comparative Evaluation thoroughly for failures or 'not graded' analytes. Laboratories are responsible for documenting and performing

Summary Statement of Deficiencies D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document maintenance as defined by the manufacturer and with at least the frequency specified by the manufacturer. This STANDARD is not met as evidenced by: Based on staff interview and record review on July 11, 2019, the laboratory failed to perform and document maintenance procedures as required and recommended by the manufacturers of the microscope. Findings Include: 1. Record review on 07/11/19 at 9: 00 AM, revealed there was no documented evidence of annual microscope maintenance for Two (2) of Two (2) microscopes from December 11, 2017 through July 10, 2019. 2. Interview with laboratory staff, on 07/11/19 at 9:05 AM, revealed the laboratory failed to establish a system in place from December 11, 2017 through July 10, 2019, to ensure microscope maintenance was performed and documented as required. 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 --