South Florida Dermatology Group, Inc

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at SOUTH FLORIDA DERMATOLOGY GROUP, INC from March 16, 2026 to April 6, 2026. The laboratory is not in compliance with 42 CFR Part 493, Requirement for Laboratories. The following Condition was cited: D2000 493.801 - Condition: Enrollment and Testing of Samples D2000 ENROLLMENT AND TESTING OF SAMPLES CFR(s): 493.801 Each laboratory must enroll in a proficiency testing (PT) program that meets the criteria in subpart I of this part and is approved by HHS. The laboratory must enroll in an approved program or programs for each of the specialties and subspecialties for which it seeks certification. The laboratory must test the samples in the same manner as patients' specimens. For laboratories subject to 42 CFR part 493 published on March 14, 1990 (55 FR 9538) prior to September 1, 1992, the rules of this subpart are effective on September 1, 1992. For all other laboratories, the rules of this subpart are effective January 1, 1994. This CONDITION is not met as evidenced by: Based on lack of records and staff interview, the laboratory failed to enroll in a Proficiency Testing (PT) program approved by the Department of Health and Human Services (HHS) and Centers for Medicare and Medicaid Services (CMS) for Mycology since January of 2025 through March 9, 2026. The findings included: 1- Review of the test menu listed on the Form CMS-116 signed by the Laboratory Director on 03/10/2026 revealed that the laboratory performed the fungal detection test using the Hardy Diagnostics Dermatophyte Test Medium (DTM) Slant. 2- Review of the patient test results revealed that the laboratory tested 32 patients from 01/02 /2025 to 03/09/2026. 3- No approved PT records found for 2025. The laboratory had 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 -- performed a twice a year peer review. 4- During a call interview on 04/06/2026 at 1: 00 PM the Laboratory Director and Office Manager confirmed that the facility failed to enroll in PT since January of 2025. -- 2 of 2 --

Summary Statement of Deficiencies D0000 A recertification survey conducted on 05/20/2022 found the VITOR F WEINMAN MD clinical laboratory not in compliance with 42 CFR Part 493, Requirements for Laboratories. 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 staff interview, the laboratory failed to ensure twice a year accuracy verification of potassium hydroxide (KOH) preps for one out of two years reviewed (2020-2021). Findings include: -Review of Quality Control policy, in the Interpretation Quality Control Section revealed that the laboratory will do an interpretation verification twice a year for KOH test. -Review of "KOH LOG" revealed that the laboratory performed one verification on 03/12/2020, no records found of another verification in 2020. During an interview on 05/20/22 at 11:00 AM, the office manager confirmed that the laboratory failed to perform twice a year accuracy verification for the KOH preps during 2020. 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 A recertification survey conducted on 7-23-2020, found that Victor F.Weinman MD clinical laboratory was not in compliance with 42 CFR Part 493, Requirements for Laboratories. D3043 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(7) The laboratory must retain cytology slide preparations for at least 5 years from the date of examination (see 493.1274(f) for proficiency testing exception). The laboratory must retain histopathology slides for at least 10 years from the date of examination. The laboratory must retain pathology specimen blocks for at least 2 years from the date of examination. The laboratory must preserve remnants of tissue for pathology examination until a diagnosis is made on the specimen. This STANDARD is not met as evidenced by: Based on slide records review and interview, the laboratory failed to retain Histolopathology Periodic acid-Schiff (PAS) positive and negative control slide for patient K19-4501 on May 1, 2019. Findings Included: A review of K19-4501 Histopathology Slide Patient Record revealed that PAS staining had been performed on the left toenail and the negative and positive control slide stains were missing for May 1st, 2019. An interview on 7-23-2020 at 12:48 PM with the laboratory manager confirmed the PAS positive and negative control slides for K19-4501 were not retained on May 1st, 2019. D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. 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 -- This STANDARD is not met as evidenced by: Based on record review and staff interview, the laboratory failed to establish written job responsibility policies for Laboratory director (LD), clinical consultant (CC), technical supervisor (TS), general supervisor (GS), and testing personnel (TP). Finding included: A review of the procedure manual revealed no documentation of job responsibility policies for LD, CC, TS, GS, TP. An interview on 7-23-2020 at 12: 48 PM with the laboratory manager confirmed that the job responsibility policy was not in the procedure manual for LD, CC, TS, GS, TP . -- 2 of 2 --

Summary Statement of Deficiencies D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) Reagents, solutions, culture media, control materials, calibration materials, and other supplies must not be used when they have exceeded their expiration date, have deteriorated, or are of substandard quality. This STANDARD is not met as evidenced by: Based on observation, record review and interview with office manager, the histopathology mycology subspecialty laboratory: A- Had expired reagents in use. B- Had no log of checking the expiration date of reagents on monthly basis. C- Had no error monitoring log sheet for DTM quality control. The findings include: Observation and record review on July 18, 2018 at 11:00 AM revealed that: 1- DTM Healthlink Dermatophyte test medium (DTM), lot # 1706104, expiration date- 2018/3/2 was in use for; Patient ID# 36884, test date 7/10/18, to be read on 7/24/18 Patient ID# 57034, test date 7/12/18 to be read on 7/26/18. 2- Record review did not show any records for DTM expiration date check on monthly basis. 3- There was no error monitoring log sheet for DTM quality control. During an interview on July 18, 2018 at 4:00 PM, office manager confirmed that: a) The DTM Healthlink Dermatophyte test medium (DTM), Lot# 1706104, expiration date- 2018/3/2 was in use for; Patient ID# 36884, test date 7/10/18, to be read on 7/24/18 Patient ID # 57034, test date 7/12/18 to be read on 7/26/18. b) There was no log of checking the expiration date of reagents on monthly basis. c) There was no error monitoring log sheet for DTM quality control, for expired reagent in use. 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 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 -- least the frequency specified by the manufacturer. This STANDARD is not met as evidenced by: Based on observation, record review and interview with office manager, the laboratory failed to have the microscope preventive maintenance records for the years 2016 to July18, 2018 two-year review period (2016 - 2018) for the subspecialty of histopathology mycology testing. The findings include: On 7/18/18 at 11:30AM, surveyor observed Nikon Alpha phot YS microscope that had Robert microscope services sticker with an original date erased with whiteout and new date of 4/19. Instrument maintenance records from July 2016 to July 18, 2018 showed documentation of microscope maintenance that did not include the service contract- invoices from Robert microscope services. During an interview on 7/18/18, at 4:00 PM, the office manager confirmed that: 1) Laboratory did not have records for any service contract and / or invoices from July 2016 to July 18, 2018 from Robert microscope services that would include microscope maintenance. 2) The microscope had Robert microscope services sticker with an original date erased with whiteout and new date of 4/19. D5477 CONTROL PROCEDURES CFR(s): 493.1256(e)(4)(g) (e) For reagent, media, and supply checks, the laboratory must do the following: (e) (4) Before, or concurrent with the initial use-- (e)(4)(i) Check each batch of media for sterility if sterility is required for testing; (e)(4)(ii) Check each batch of media for its ability to support growth and, as appropriate, select or inhibit specific organisms or produce a biochemical response; and (e)(4)(iii) Document the physical characteristics of the media when compromised and report any deterioration in the media to the manufacturer. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on record review and interview, the laboratory failed to check each batch of Dermatophyte Test Medium for its ability to support growth and produce a biochemical response from July 2016 to July 18, 2018- two year record review period. The findings include: Review of Dermatophyte Test Medium quality control documentation records from July 2016 to July 18, 2018, showed that the laboratory had not checked each batch or lot number of Dermatophyte Test Medium for its ability to support growth and produce a biochemical response from July 2016 to July 18, 2018. During an interview on 7/18/18 at 4:00 PM, the office manager confirmed that the laboratory had not checked each batch or lot number of Dermatophyte Test Medium for its ability to support growth and produce a biochemical response from July 2016 to July 18, 2018- two year record review period. -- 2 of 2 --