Dermatology Partners - Lancaster

Summary Statement of Deficiencies D0000 A recertification survey was conducted by the Pennsylvania State Agency at Dermatology Partners - Lancaster on 01/09/2026. The laboratory was found out of compliance with the following conditions: 493.1441 Condition: Laboratories performing high complexity testing; laboratory director. 493.1290 Condition: Postanalytic Systems. D3011 FACILITIES CFR(s): 493.1101(d) Safety procedures must be established, accessible, and observed to ensure protection from physical, chemical, biochemical, and electrical hazards, and biohazardous materials. This STANDARD is not met as evidenced by: Based on lack of documentation and interview with the Senior Director of Clinical Development (SDCD), the laboratory failed to have safety data sheets (SDS) accessible to ensure protection from chemical reagents and stains for 2 of 2 reagents stored in the laboratory from 08/14/2024 to 01/09/2026. Findings Include: 1. On the day of survey, 01/09/2026, at 11:39 am, the laboratory could not provide SDS to ensure protection from the following chemical reagents and stains stored in the laboratory from 08/14/2024 to 01/09/2026: - Avantik Tissue Marking Dye Kit, lot #'s 229809, 230858, 190249. - Avantik Embedding Matrix, EM0199. 2. The SDCD confirmed the above findings on 1/09/2026 at 11:56 am. D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) (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 Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 4 -- instructions, if provided. These conditions must be monitored and documented and, if applicable, include the following: (b)(1) Water quality. (b)(2) Temperature. (b)(3) Humidity. (b)(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 observation in the laboratory, review of laboratory temperature records, and interview with the Senior Director of Clinical Development (SDCD), the laboratory failed to monitor temperatures to ensure acceptable reagent storage conditions were maintained when the laboratory was closed for 452 of 513 days from 08/14/2024 to 01 /09/2026. Findings include: 1. On the day of survey, 01/09/2026, at 10:08 am, during the tour of the laboratory, the surveyor observed the following reagents stored in the laboratory: - Avantik Embedding Matrix for Frozen Sections, storage requirements 39 to 86 F. 2. Review of the laboratory's temperature records revealed the laboratory failed to monitor and document temperatures to ensure acceptable reagent storage conditions were maintained for 452 of 513 days from 08/14/2024 to 01/09/2026 when the laboratory was closed. 3. The laboratory performed 1100 dermatopathology microscopic examinations in 2025 (CMS 116, estimated annual volume, dated 01/07 /2026). 4. The SDCD confirmed the above findings on 1/09/2026 at 11:56 am. D5800 POSTANALYTIC SYSTEMS CFR(s): 493.1290 Each laboratory that performs nonwaived testing must meet the applicable postanalytic systems requirements in 493.1291 unless HHS approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7) that provides equivalent quality testing. The laboratory must monitor and evaluate the overall quality of the postanalytic systems and correct identified problems as specified in 493. 1299 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: Based on review of patient test reports and interview with the Senior Director of Clinical Development (SDCD), the laboratory failed to meet applicable postanalytical systems requirements in 493.1291 for 2 of 2 patient test reports reviewed for microscopic dermatopathology examinations performed from 08/14/2024 to the date of the survey. (refer to D5805). D5805 TEST REPORT CFR(s): 493.1291(c) (c) The test report must indicate the following: (c)(1) For positive patient identification, either the patient's name and identification number, or a unique patient identifier and identification number. (c)(2) The name and address of the laboratory location where the test was performed. (c)(3) The test report date. (c)(4) The test performed. (c)(5) Specimen source, when appropriate. (c)(6) The test result and, if applicable, the units of measurement or interpretation, or both. (c)(7) Any information regarding the condition and disposition of specimens that do not meet the laboratory's criteria for acceptability. -- 2 of 4 -- This STANDARD is not met as evidenced by: Based on review of patient test reports (Mohs maps) and interview with the Senior Director of Clinical Development (SDCD), the laboratory failed to include the address of the location where dermatopathology microscopic (Mohs) slide examinations were performed on 2 of 2 patient test reports reviewed from 08/14/2024 to the day of survey. Findings Include: 1. On the day of survey, 01/09/2026, at 10:12 am, review of 2 of 2 patient test reports (Mohs maps) revealed the laboratory failed to include the address of the laboratory where dermatopathology microscopic (Mohs) slide examinations were examined from 08/14/2024 to 01/09/2026. 2. The laboratory performed 1100 dermatopathology microscopic examinations in 2025 (CMS 116, estimated annual volume, dated 01/07/2026). 3. The SDCD confirmed the above findings on 1/09/2026 at 11:56 am. Repeat deficiency* D6076 LABORATORY DIRECTOR CFR(s): 493.1441 The laboratory must have a director who meets the qualification requirements of 493. 1443 of this subpart and provides overall management and direction in accordance with 493.1445 of this subpart. This CONDITION is not met as evidenced by: Based on record review and interview with the Senior Director of Clinical Development (SDCD), the Laboratory Director (LD) failed to provide overall management and direction of the laboratory in accordance with 493.1445 from 08/14 /2024 to 01/09/2026. Refer to D6086 and D6093. D6086 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(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 record review, lack of documentation, and interview with the Senior Director of Clinical Development (SDCD), the laboratory failed to ensure established procedures for the twice annual verification of accuracy for dermatopathology microscopic examination testing were followed for 4 of 4 peer review evaluations performed from 8/14/2024 to 01/09/2026. Findings include: 1. The laboratory's Proficiency Testing policy stated "Upon receipt of the pathology report from the Dermatopathologist, diagnosis of the slide specimen will be matched to the in-house diagnosis by the physician. Stain quality, visibility of epidermis, and next step required will also be compared against records." 2. On the day of survey, 01/09/2026 at 9:38 am, the laboratory failed to provide documentation for the review performed upon receipt of pathology reports from the Dermatopathologist for the following 4 of 4 peer review evaluations completed from 08/14/2024 to 01/09/2026: - Dermatology Partners - Semiannual Proficiency Testing Year: 2024 Testing Period: January 1,2024 - June 30, 2024 - Dermatology Partners - Semiannual Proficiency Testing Year: 2024 Testing Period: July 1 - December 31 - Dermatology Partners - Semiannual Proficiency Testing Year: 2025 Testing Period: January 1 - June 30 - Dermatology Partners - Semiannual Proficiency Testing Year: 2025 Testing Period: July 1 - December 31 3. The SDCD confirmed the above findings on 1/09/2026 at 11:56 am. -- 3 of 4 -- D6093 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(5) (e)(5) Ensure that the quality control and quality assessment programs are established and maintained to assure the quality of laboratory services provided and to identify failures in quality as they occur; This STANDARD is not met as evidenced by: Based on record review, lack of documentation, and interview with the Senior Director of Clinical Development (SDCD), the laboratory director (LD) failed to ensure a Quality Assurance (QA) program was maintained and documented to ensure the quality of services provided for 5 of 17 months from 08/14/2024 to 01/09/2026. Findings include: 1. The Laboratory's Quality Assurance Procedure stated, "Monthly the nurse or Mohs histotech, along with the laboratory director or testing personnel, will check off the line items on the Monthly Quality Assurance Checklist." 2. On the date of the survey, 01/09/2026 at 9:49 am, the laboratory failed to provide monthly documentation for the QA evaluation performed to assess the laboratory's pre- analytical, analytical, and post-analytical processes for the following 5 of 17 months from 08/14/2024 to 01/09/2026: - 8/2024, 9/2024, 10/2024, 11/2024, 12/2024. 3. The SDCD confirmed the above findings on 1/09/2026 at 11:56 am. Repeat deficiency* D6128 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(9) (b)(9) Thereafter, evaluations must be performed at least annually unless test methodology or instrumentation changes, in which case, prior to reporting patient test results, the individuals performance must be reevaluated to include the use of the new test methodology or instrumentation. This STANDARD is not met as evidenced by: Based on review of personnel competency assessment records and interview with the Senior Director of Clinical Development (SDCD), the Technical Supervisor (TS) failed to ensure that annual competency evaluations were documented to ensure 1 of 1 testing personnel (TP) who conduct preanalytical, analytical, and postanalytical phases of testing maintained their competency from 08/14/2024 to 01/09/2026. Findings Include: 1. On the day of the survey, 01/09/2026 at 9:20 am, review of the laboratory's personnel competency assessment records revealed the TS failed to ensure annual competency was documented to ensure 1 of 1 TP (CMS 209, personnel #2, dated 01/07/2026) that performed the following testing maintained their competency from 08/14/2024 to 01/09/2026: - Mohs Dermatopathology microscopic examination 2. The laboratory performed 1100 dermatopathology microscopic examinations in 2025 (CMS 116, estimated annual volume, dated 01/07/2026). 3. The SDCD confirmed the above findings on 1/09/2026 at 11:56 am. -- 4 of 4 --

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 review of laboratory records and interview with the Director of Training and Compliance (DTC), the laboratory failed to obtain a permit from the Pennsylvania Department of Health (PA DOH) and CLIA Certificate of Compliance in order to operate a clinical laboratory in Pennsylvania prior to the start of patient testing from 03 /27/2024 to 04/30/2024. Findings: 1. On the date of the survey, 08/14/2024 at 11:00 am, review of 1 of 1 MOHS surgery diagrams revealed the laboratory began patient testing on 03/27/2024. 2. Further review of laboratory records and the CMS ASPEN database revealed the laboratory's inital application for a PA Clinical Laboratory permit and CLIA Certificate of Compliance was processed on 04/05/2024 by the PA DOH. 3. The letter sent to the laboratory from the PA DOH on April 5, 2024 stated, "Your facility is being granted provisional approval to perform patient testing. Your facility must receive the Certificate of Registration prior to starting patient testing." 4. The laboratory's Certificate of Registration was mailed to the facility on 04/30/2024 by CMS. 5. The DTC confirmed the findings above on 08/14/2024 at 11:00 am. 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. 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 observation of the laboratory, lack of documentation, and interview with the Director of Training and Compliance (DTC), the laboratory failed to perform and document maintenance/function checks for 1 of 1 microscope used to perform MOHS microscopic slide examinations in 2024. Findings include: 1. On the day of survey, 08 /16/2024 at 11:00 am, observation of the laboratory revealed the maintenance sticker on 1 of 1 microscope used to perform MOHS micrographic slide examinations in 2024 stated the following: - Microscope serial number (S/N) 290447. - Maintenance completed on 6-14-2023. - Maintenance due 6-2024. 2. The laboratory failed to provide maintenance records for 1 of 1 microscope (S/N 290447) for maintenance due 06/2024. 3. The DTC confirmed the findings above on 08/16/2024 at 11:00 am. D5805 TEST REPORT CFR(s): 493.1291(c) The test report must indicate the following: (c)(1) For positive patient identification, either the patient's name and identification number, or a unique patient identifier and identification number. (c)(2) The name and address of the laboratory location where the test was performed. (c)(3) The test report date. (c)(4) The test performed. (c)(5) Specimen source, when appropriate. (c)(6) The test result and, if applicable, the units of measurement or interpretation, or both. (c)(7) Any information regarding the condition and disposition of specimens that do not meet the laboratory's criteria for acceptability. This STANDARD is not met as evidenced by: Based on review of patient test reports and interview with the Director of Training and Compliance (DTC), the laboratory failed to include the address of the location where MOHS microscopic slide examinations were performed on the patient test report from 03/27/2024 to the date of survey. Findings include: 1. On the date of survey, 08/14 /2024 at 11:15 am, review of 1 of 1 MOHS micrograhpic surgery diagram (Case # LH 001-24) revealed the documentation of MOHS micrographic slide examination test results did not include the address of where the tests were performed from 03/27/2024 to 08/14/2024. 2. The DTC confirmed the finding above on 08/14/2024 at 11:15 am. D6094 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(5) The laboratory director must ensure that the quality assessment programs are established and maintained to assure the quality of laboratory services provided and to identify failures in quality as they occur. This STANDARD is not met as evidenced by: Based on review of the laboratory's quality assurance (QA) policies and records, lack of documentation, and interview with the Director of Training and Compliance (DTC), the laboratory director (LD) failed to ensure quality assessment (QA) programs were maintained to assure the quality of laboratory services and to identify failures in quality as they occur from March 2024 to July 2024. Findings Include: 1. The laboratory's Quality Assurance procedure stated, "The lab director or their assigned designee will also review and sign off the checklist quarterly." 2. On the day of survey, 08/14/2024 at 10:00 am, review of the laboratory's Monthy QA checklists revealed technical supervisor #2 (TS) (CMS 209 personnel # 2) completed and signed -- 2 of 3 -- off on 5 of 5 montly QA reports reviewed from March 2024 to July 2024. 3. The laboratory failed to provide a delegation of duties signed by the LD for TS #2. 4. The DTC confirmed the findings above on 08/14/2024 at 10:00 AM. 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 results. This STANDARD is not met as evidenced by: Based on review of personnel training records, test reports, and interview with the Director of Training and Compliance (DTC), the laboratory director (LD) failed to ensure that 1 of 2 testing personal (TP) received the appropriate training and demonstrated their ability to perform MOHS microscopic slide examinations reliably to provide and report accurate results before testing patient specimens from 03/27 /2024 to 4/18/2024. Findings include: 1. On the day of the survey, 08/14/2024 at 10: 45 am, review of personnel training records revealed the LD failed to ensure that 1 of 2 TP (CMS 209 personnel #2) received the appropriate training to ensure MOHS microscopic examinations results were performed reliably and accurately before patient testing from 03/27/2024 to 04/18/2024. 2. Further review or personnel training and patient test reports (MOHS Surgery Diagram) revealed the following: - TP # 2 performed MOHS micrographic slide examinations starting from 03/27/2024. - Training records for TP # 2 were completed by the LD on 04/18/2024. 3. The DTC confirmed the findings above on 8/14/2024 at 10:45 AM. -- 3 of 3 --