Carlisle Dermatology Group Llc

Summary Statement of Deficiencies D3009 FACILITIES CFR(s): 493.1101(c) The laboratory must be in compliance with applicable Federal, State, and local laboratory requirements. This STANDARD is not met as evidenced by: Based on lack of documentation and interview with the Clinical Manager (CM), the laboratory failed to monitor and document room temperature to ensure reagent storage conditions were met for 2 of 2 years when virology, mycology, and chemistry testing was performed from 04/03/2024 to 12/05/2025. Findings include: 1. On the day of the survey, 12/05/2025 at 11:15 am, the laboratory failed to provide documentation for the room temperature readings performed to ensure storage conditions were met for the following reagent kits used for virology, mycology, and chemistry testing for 2 of 2 years from 04/03/2024 to 12/05/2025: - QuickVue SARS Antigen Test reagents (manufacturer storage temperature 15 to 30 Celsius). - Henry Schein One Step+ hCG Urine Strip Test reagents (manufacturer storage temperature 2 to 30 Celsius). - EDM3 Solutions Potassium Hydroxide 20% (manufacturer storage temperature states "room temperature"). 2. The CM confirmed the findings above on 12/5/2025 at 1:22 pm. 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 deteriorated, or are of substandard quality. This STANDARD is not met as evidenced by: Based on record review and interview with the Clinical Manager (CM), the laboratory 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 -- failed to ensure that 2 of 2 reagents used for Potassium Hydroxide (KOH) microscopic slide examinations were not used beyond the expiration dates from 3/3 /2025 to 8/10/2025. Findings include: 1. On the day of the survey, 12/05/2025 at 8:45 am, review of the laboratory's chemical log revealed the following 2 of 2 expired reagents used for Potassium Hydroxide (KOH) microscopic slide examinations from 3 /3/2025 to 8/10/2025: - 1 opened bottle of Henry Schein Chlorazol Black E (Lot #2103, expired 4/13/2024). - 1 opened bottle of Henry Schein Potassium Hydroxide (KOH), 20% (Lot #2131, expired 5/11/2024). 2. The laboratory performed 33 KOH microscopic examinations from 3/3/2025 to 8/10/2025 (Patient KOH logs dated 2/3 /205 to 8/13/2025). 3. The CM confirmed the findings above on 12/5/2025 at 1:22 pm. D5431 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(2) (a)(2) Function checks as defined by the manufacturer and with at least the frequency specified by the manufacturer. Function checks must be within the manufacturers established limits before patient testing is conducted. (b) Equipment, instruments, or test systems developed in-house, commercially available and modified by the laboratory, or maintenance and function check protocols are not provided by the manufacturer. The laboratory must do the following: This STANDARD is not met as evidenced by: Based on review of the laboratory's Microscope Policy, lack of documentation, and interview with the Clinical Manager (CM), the laboratory failed to follow established policies when preventative maintenance was performed for 2 of 3 microscopes used for Potassium Hydroxide (KOH) and Scabies microscopic slide examinations from 4 /03/2024 to the day of survey. Findings Include: 1. The laboratory's Microscopes Policy stated, "5. Document daily, monthly care. 6. Annual preventative maintenance". 2. On the day of survey, 12/05/2025 at 12:02 pm, the laboratory failed to provide maintenance records for the annual preventative maintenance performed for the following 2 of 3 microscopes used for KOH and Scabies microscopic examinations from 4/03/2024 to 12/05/2025: - Omax Digital Compound Binocular LED Microscope (model MD827S30L, S/N G2019042782) - Omax Digital Compound Binocular LED Microscope (model MD827S30L, S/N G2019055298) 3. The laboratory performed 229 KOH and Scabies microscopic slide examinations in 2024 (CSM 116, estimated annual volume, dated 12/05/2025). 4. The CM confirmed the findings above on 12/5/2025 at 1:22 pm. D5441 CONTROL PROCEDURES CFR(s): 493.1256(a)(b)(c)(g) (a) For each test system, the laboratory is responsible for having control procedures that monitor the accuracy and precision of the complete analytic process. (b) The laboratory must establish the number, type, and frequency of testing control materials using, if applicable, the performance specifications verified or established by the laboratory as specified in 493.1253(b)(3). (c) The control procedures must-- (c)(1) Detect immediate errors that occur due to test system failure, adverse environmental conditions, and operator performance. (c)(2) Monitor over time the accuracy and precision of test performance that may be influenced by changes in test system performance and environmental conditions, and variance in operator performance. -- 2 of 3 -- This STANDARD is not met as evidenced by: Based on review of laboratory records, lack of documentation, and interview with the Clinical Manager (CM), the laboratory failed to establish and maintain a quality control (QC) procedure for Potassium Hydroxide (KOH) and Scabies examinations performed for 2 of 2 years from 04/03/2024 to the day of survey. Findings include: 1. The laboratory's KOH Quality Control Procedure stated, "For the first case of the day, scrapings are taken in the room on both the affected and non-affected areas and placed on a glass slide." 2. On day of survey, 12/05/2025 at 11:06 am, review of the laboratory's KOH Quality Control (QC) logs revealed the laboratory failed to document the skin scraping results (affected/non affected areas) used as QC per laboratory policy for the first case of the day when KOH examinations were performed for 2 of 2 years from 04/03/2025 to 12/05/2025. 3. The laboratory failed to provide a QC policy for Scabies examinations performed. 4. The laboratory performed 229 KOH and Scabies microscopic slide examinations in 2024 (CSM 116, estimated annual volume, dated 12/05/2025). 5. The CM confirmed the findings above on 12/5/2025 at 1:22 pm. D6013 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(3)(ii) (e)(3)(ii) Verification procedures used are adequate to determine the accuracy, precision, and other pertinent performance characteristics of the method; and This STANDARD is not met as evidenced by: Based on lack of documentation, review of Peer Review records and interview with the Clinical Manager (CM), the Laboratory Director (LD) failed to ensure procedures were established and maintained for the twice annual verification of accuracy of Potassium Hydroxide (KOH) and Scabies examinations performed for 2 of 2 years from 04/03/2024 to 12/05/2025. Findings Include: 1. The laboratory's KOH Peer Review/Proficiency Testing Procedure stated, "Semi-annually, the tech or Risk Manager will send two cases via electronic imaging containing the original images, label it with only the patient chart number, and send it out for a peer review by a Board Certified Dermatopathologist. Upon receipt of the pathology report from the Dermatopathologist, diagnosis of the specimen image will be matched to the in-house diagnosis by the physician." 2. On the day of the survey, 12/5/2025 at 10:49 am, review of the laboratory's Peer Review records revealed the laboratory failed to ensure two cases were sent to the laboratory's designated Board Certified Dermatopathologists for KOH peer review as per laboratory policy for 2 of 2 years from 04/03/2024 to 12/05/2025. 3. Further review of the laboratory's peer review records revealed the following peer review reports were not reviewed or assessed by the physician upon receipt by the laboratory in 2024: - Scabies peer review reports: 3/7 /2024, 3/8/2024, 3/13/2024, 7/12/2024, 7/26/2024, 9/10/2024, 9/13/2024. - KOH peer review reports: 1/23/2024, 1/26/2024, 2/21/2024, 2/27/2024, 6/18/2024, 8/1/2024, 8/16 /2024, 8/21/2024. 4. The laboratory failed to provide a procedure for the verification of accuracy for Scabies examinations. 5. The laboratory performed 229 KOH and Scabies microscopic slide examinations in 2024 (CSM 116, estimated annual volume, dated 12/05/2025). 6. The CM confirmed the findings above on 12/5/2025 at 1:22 pm. -- 3 of 3 --

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 of the laboratory and interview with the clinical manager (CM), the laboratory failed to ensure that reagents and supplies used for macroscopic dermatopathology examinations were not used beyond the expiration dates from 12/31 /2023 to the date of the survey. Findings Include: 1. On the date of the survey, 04/03 /2024 at 12:10 pm, a laboratory tour revealed the following reagent used for macroscopic dermatopathology examinations from 12/31/2023 to 04/03/2024 was expired: - 1 of 1 Tissue Marking Dye-Green CR2056 GN- Lot 138465, Expiration Date 12/31/2023. 2. The CM confirmed the findings above on 04/03/2024 at 12:30 pm. 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 observation of the laboratory and interview with the clinical manager (CM), the laboratory failed to perform and document maintenance on 1 of 1 thermometer used to ensure proper working conditions were maintained when macroscopic 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 -- dermatopathology examinations were performed from 08/01/2023 to the day of the survey. Findings Include: 1. On 04/03/2024, at 12:15 pm, an observation of the laboratory revealed that 1 of 1 Thermo Scientific (S/N 150253534) thermometer used to monitor room temperature (RT) and humidity to maintain proper working condition for 2 of 2 Avantik QS 12 cryostats was expired on 11/27/2017. 2. According to Avantik QS 12 Cryostat manufacturer's instructions the environmental operating temperature should be between 5C to 35C and the humidity should be less than 60%. 3. The laboratory performed 1,797 dermatopathology examinations in 2023 (CMS 116 annual test volume) 4. The CM confirmed the findings above on 04/03/2024 at 12:30 pm. -- 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 lack of documentation, and interview with the Assistant Office Manager, the laboratory failed to ensure that 5 of 5 TP performed the verification of accuracy for Scabies (parasitology) microscopic examinations from 03/10/2020 through the date of survey. Findings Include: 1. On the day of survey, 08/01/2022 at 10:00 am, the laboratory could not provide documentation of twice annual verification of accuracy for Scabies (parasitology) microscopic testing from 03/10/2020 to 08/01/2022 for 5 of 5 TP (CMS 209 personnel # 1, 2,3,4, and 5). 2. The laboratory performed 20 Scabies microscopic examinations in 2021. 3. The Assistant Office Manager confirmed the findings above on 08/01/2022 around 10:30 am. D6053 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) The technical consultant is responsible for evaluating and documenting the performance of individuals responsible for moderate 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's procedure manuals, review of competency assessment records and interview with the Assistant Office Manager, the Technical Consultant (TC) failed to evaluate and document the performance of 2 of 5 testing personnel (TP) responsible for performing Potassium Hydroxide (KOH) and Scabies examinations 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 -- for their semi-annual competency from June 2020 till the day of survey. Findings include: 1. On the day of survey, 08/01/2022 at 09:45 am, the laboratory was unable to produce the semi-annual competency assessment records for 2 of 5 TP (CMS 209 personnel #2 and #5) that performed mycology (KOH) and parasitiology (Scabies) slide examinations. -TP # 2 started patient testing 06/2020. -TP # 5 started patient testing 11/2021. 2. The laboratory performed 377 mycology/parasitology tests in 2021. 3. The Assitant Office Manager confirmed the above findings 08/01/2022 around 10:30 am. 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 competency assessment record and interview with the Assistant Office Manager, the Technical Supervisor (TS)failed to evaluate and document the performance of 1 of 2 testing personnel (TP) responsible for Mohs micrographic surgery specimen examinations at least semi-annually during their first year from July 2021 to the day of survey. Findings include: 1. On the date of survey, 08/01/2022 at 10:15 am, the laboratory could not provide semi-annual competency assessment documentation for 1 of 2 TP (CMS 209 personnel # 2) who performed Mohs micrographic surgery examinations during their first year. 2. The Assistant Office Manager confirmed that TP#2 joined the practice in 2020 and started performing Mohs micrographic examinations in July 2021. 3. The laboratory performed 2,024 Mohs micrographic examinations in 2021. 4. The Assistant Office Manager confirmed the findings above 08/01/2022 around 10:30 am. -- 2 of 2 --

Summary Statement of Deficiencies D6046 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(8) (b) The technical consultant is responsible for-- (b)(8) Evaluating the competency of all testing personnel and assuring that the staff maintain their competency to perform test procedures and report test results promptly, accurately and proficiently. This STANDARD is not met as evidenced by: Based on laboratory personnel interview and review of the laboratory Testing Personnel records on the date of the survey, the Technical Consultant failed to evaluate the competancy for 2 of 2 testing personnel. Findings include: 1. Review of the laboratory Testing Personnel records revealed no competency records for 2 of 2 Testing Personnel who performed KOH & Scabies tests, from 01/08/2019 through 03 /09/2020 . 2. 97 KOH tests & 30 Scabies tests were performed from January 2019 through March 2020. 3. During the survey at 12:30 pm, the assistant office manager confirmed the above 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 --