Parks Dermatology Center Llc

Summary Statement of Deficiencies D0000 At the time of the announced, onsite recertification survey, Parks Dermatology Center, LLC was found to not be in compliance with the CLIA laboratory requirements of 42 CFR 493. D3001 FACILITIES CFR(s): 493.1101(a)(1) (a) The laboratory must be constructed, arranged, and maintained to ensure the following: (a)(1) The space, ventilation, and utilities necessary for conducting all phases of the testing process. This STANDARD is not met as evidenced by: Based on observation, record review, and staff interview, the laboratory failed to use chemicals under a fume hood when required for an undetermined amount of time. The findings include: During the tour of the laboratory on 7/15/25 around 1:10pm, the chemical stain line used for Mohs surgery (a procedure used to treat skin cancer) was observed. The stains used in the stain line included 100% alcohol and Eosin. A review of the chemical's safety data sheets (SDS) was performed. 1. The SDS for the 100% Alcohol stated "Use only outdoors or in a well-ventilated area. Do not breathe dust /fume/gas/mist/vapors/spray." 2.. The SDS for the Eosin stated "Do not breathe vapors, aerosols. Avoid substance contact. Ensure adequate ventilation." During the interview with the Histotechnologist on 7/15/25 at 1:20pm, it was confirmed the room does not have a ventilation system and a fume hood over the stain line is required for respiratory safety. D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) (d) Reagents, solutions, culture media, control materials, calibration materials, and other supplies must not be used when they have exceeded their expiration date, have 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 -- deteriorated, or are of substandard quality. This STANDARD is not met as evidenced by: Based on observation and staff interview, the laboratory failed to ensure the potassium hydroxide (KOH) was not expired prior to patient testing. Findings include: Observations made during a tour of the laboratory on 7/15/25 at 1:30 PM, showed one bottle of "Potassium Hydroxide" with lot number 2906-02 expired 12/31/2023. During an interview on 7/15/25 at 1:35 PM with the Histotechnologist, it was confirmed the bottle of KOH was expired. -- 2 of 2 --

Summary Statement of Deficiencies D0000 At the time of the announced, onsite recertification survey, Parks Dermatology Center, LLC was found to not be in compliance with the CLIA laboratory requirements of 42 CFR 493. 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. This STANDARD is not met as evidenced by: Based on record review and interview with the Clinical Manager, the laboratory failed to perform competency assessments on 4 out of 4 Testing Personnel who perform KOH (potassium hydroxide) and Scabies testing for two of two years reviewed. (2021- 2022) The findings include: Review of Testing Personnel records showed no laboratory competency assessment was performed for testing persons A, B, C, and D. During an interview on 6/2/23 at 10:30 AM the Clinical Manager confirmed there was no documentation of laboratory competency assessments on the testing personnel since 2019. 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 send 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 -- histopathology patient slides for peer review more than once annually in 2022 and failed to perform twice annual verification of accuracy for the subspecialties of Mycology and Parasitology in 2021 and 2022. Findings include: 1. The record review of documented peer review for 2022 showed that patient slides from 2022 were sent on 3/13/2023 to ASMS (American Society of Mohs Surgery) to verify accuracy of results. There was no other documented peer review for 2022. 2. The review of the MLE (Medical Laboratory Evaluation) proficiency testing results for KOH (potassium hydroxide) and Scabies testing showed the laboratory participated in the first testing event in 2021 and the second testing event in 2022. The laboratory could not locate records showing participation in the second testing event of 2021 or the first testing event of 2022. The interview with the Clinical Manager on 6/2/23 at 10:30am confirmed that slides were only sent out once for peer review in 2022. She stated that she was unable to locate the KOH and Scabies results for the missing MLE testing events in 2021 and 2022. -- 2 of 2 --

Summary Statement of 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 staff interview, the facility failed to document the temperature of the Cryostat instrument used to cut tissue for Histopathology testing for eight of eight testing days reviewed in December 2018. Findings included: The record review of the "Cryostat Temperature Log" for 2018 shows that no temperature was documented on December 4th, 5th, 6th, 10th, 11th, 12th, 18th, and 19th. The record review of the MOHs patient testing log showed 10 patients tested on the 4th, 9 patients on the 5th, 9 patients on the 6th, 10 patients on the 10th, 10 patients on the 11th, 10 patients on the 12th, 12 patients on the 18th, and 10 patients on the 19th. Interview with the clinic manager on 5/24/19 at 9:30AM confirmed that no temperature was documented for the month of December. 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 --