Rmg Dermatology

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 lack of documentation, review of laboratory policies and procedures, and interview with the laboratory representative; the laboratory failed to perform bi-annual method accuracy evaluations for Potassium Hydroxide (KOH) testing in 2023 through the date of the survey,07/16/2025. Findings include: 1. Review of laboratory records revealed that one peer review/ bi-annual method accuracy evaluation had been completed in 2024 through the date of the survey,07/16/2025. 2. Review of laboratory policies and procedures revealed a document titled "KOH Log Instructions" which stated "8. If Dr Sisto or Dr. Pipitone perform a KOH and each check the results, blinded, this is a QA test and should be documented on the QA form in the KOH book. QA- Quality assurance 9. QA testing will be performed biannually." 3. During the survey on 07-16-2025, at 10:05 am, the laboratory representative confirmed the laboratory failed to perform bi-annual method accuracy evaluations for KOH in 2023 through the date of the survey 07-16-2025. D5221 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(d) All proficiency testing evaluation and verification activities must be documented. This STANDARD is not met as evidenced by: Based on review of laboratory policies and procedures, lack of documentation, and interview with the laboratory representative; the laboratory failed evaluate results of 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 -- Mohs bi-annual method accuracy (proficiency testing/peer reviewed histopathology interpretations) for two of five events from the beginning of 2023 to the date of survey, 07/17/2025. Findings include: 1.Review of laboratory policies and procedures revealed the procedure titled, "Mohs Laboratory Subject: proficiency testing" which stated, "This laboratory instituted its own external quality control proficiency testing program for mohs micrographic surgery and cutaneous oncology ... Once slides have been reviewed and returned, Dr. Pipitone will also review, comment as necessary and sign off on the proficiency testing worksheet." 2. Review of laboratory records revealed a lack of documentation of evaluations of results upon receipt of peer reviewed Mohs histopathology interpretations for two of five reviewed bi-annual method accuracy events. Mohs bi-annual method accuracy events missing laboratory director review: April 2025 April 2024 3. Interview with the laboratory representative at 10:08 am, on 07/17/2025, confirmed the laboratory failed to evaluate results of Mohs bi-annual method accuracy (proficiency testing/peer reviewed histopathology interpretations) for two of five events from the beginning of 2023 to the date of survey, 07/16/2025. -- 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 review of Proficiency Testing (PT) procedures, documentation, and interview with laboratory staff; the laboratory failed to verify the accuracy of its histopathology procedures twice, annually. Findings: 1. Review of PT documentation revealed that PT was not performed twice in 2019. 2. During survey date October 16, 2019 at 12:00 PM, laboratory staff confirmed the surveyor's findings. D6127 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(9) The technical supervisor is responsible for evaluating and documenting the performance of individuals responsible for high complexity testing at least semiannually during the first year the individual tests patient specimens. This STANDARD is not met as evidenced by: Based on review of Laboratory Personnel Report (CMS 209), personnel records and interview with laboratory personnel; the technical supervisor fail ed to evaluate and document the performance of individuals responsible for histopathology (Mohs) testing. Findings: 1. Review of personnel records and form CMS -209, revealed that out of the 6 individuals listed, testing person # 4 did not received its semiannual evaluation. 2. During survey date October 16, 2019 at 12:00 PM, laboratory staff confirmed the surveyor's findings 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 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 direct observations; review of policies and procedures manuals and maintenance records; and interview, the laboratory failed to perform and document maintenance as defined by the manufacturer and with at least the frequency specified by the manufacturer. Findings: 1. During survey date 01/23/18, the surveyor observed that the laboratory used the following equipment to perform histopathology procedures: a. Microscope b. Microtome c. Fume hood e. Stainer 2. There were no procedures that described how the laboratory maintained the Microtome and Stainer. However, the procedure for the Airfiltronix fume hood describes a series of filters that may be used with the fume hood. However, the laboratory did not define the type of filter used in the fume hood. Nor did the lab define a specific maintenance schedule for changing the filter. 3. There were no records to show that the laboratory performed and maintenance or preventative maintenance on its Microtome, Fume hood, and Stainer. 4. During survey date 01/23/18 at 1:00 PM, the laboratory director confirmed the surveyor's findings. D6102 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(12) The laboratory director must ensure that prior to testing patients' specimens, all personnel have the appropriate education and experience, receive the appropriate training for the type and complexity of the services offered, and have demonstrated that they can perform all testing operations reliably to provide and report accurate 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 -- results. This STANDARD is not met as evidenced by: Based on review of personnel records and interview, the laboratory director failed to ensure that prior to testing patients' specimens, all personnel have the appropriate education and experience, and have demonstrated that they can perform all testing operations reliably to provide and report accurate results. Findings: 1. Review of personnel records for persons who process histopathology specimens revealed that 1 of 5 testing personnel was educated in a foreign country. However, there was no documentation to show what the U. S. equivalent education is. The documentation submitted to the surveyor only interprets the language. 2. During survey date 01/23/18 at 1:00 PM, the laboratory director confirmed the surveyor's findings. D6124 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(8)(iv) The procedures for evaluation of the competency of the staff must include, but are not limited to direct observation of performance of instrument maintenance and function checks. This STANDARD is not met as evidenced by: Based on direct observations; review of laboratory records; and interview, the procedures for evaluation of the competency of the staff did not include direct observation of performance of instrument maintenance and function checks. Findings: 1. During survey date 01/23/18, the surveyor observed that the laboratory performed histopathology procedures while using the following equipment: Microtome, Microscope, Fume Hood, and Stainer. 2. There was no documentation to show that the laboratory personnel performed maintenance and/or preventative maintenance on its Microtome, Fume Hood, and Stainer. 3. During survey date 01/23/17 at 1:00 PM, the laboratory director confirmed the surveyor's findings. -- 2 of 2 --