Dermatology Partners - Hanover

Summary Statement of Deficiencies D0000 A recertification survey was conducted by the Pennsylvania State Agency at Dermatology Partners - Hanover on 01/15/2026. The laboratory was found out of compliance with the following condition: 493.1441 Condition: Laboratories performing high complexity testing; laboratory director. D3031 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3) Analytic systems records. Retain quality control and patient test records (including instrument printouts, if applicable) and records documenting all analytic systems activities specified in 493.1252 through 493.1289 for at least 2 years. In addition, retain the following: 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 retain analytic systems records for 3 of 15 months as required from 10/23/2024 to 01/15/2026. Findings include: 1. On the day of survey, 01/15/2026 at 9:38 am, the laboratory failed to provide documentation of the following analytic system records for 3 of 15 months from 10/23/2024 to 01/15 /2026: - October 2024, November 2024, December 2024 Temperature logs - October 2024, November 2024, December 2024 Maintenance logs 2. The SDCD confirmed the above findings on 1/15/2026 at 11:35 am. D5205 COMPLAINT INVESTIGATIONS CFR(s): 493.1233 The laboratory must have a system in place to ensure that it documents all complaints and problems reported to the laboratory. The laboratory must conduct investigations of complaints, when appropriate. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 5 -- 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 establish and maintain a policy to ensure all complaints and problems reported to the laboratory are documented and investigated when needed for 15 of 15 months from 10/23/2024 to 01/15/2026. Findings include: 1. On the day of survey, 01/15/2026 at 9:38 am, the laboratory could not provide a policy to ensure all complaints and problems reported to the laboratory were documented and investigated as needed for 15 of 15 months from 10 /23/2024 to 01/15/2026. 2. The SDCD confirmed the above findings on 1/15/2026 at 11:35 am. D5311 SPECIMEN SUBMISSION, HANDLING, AND REFERRAL CFR(s): 493.1242(a) (a) The laboratory must establish and follow written policies and procedures for each of the following, if applicable: (a)(1) Patient preparation. (a)(2) Specimen collection. (a)(3) Specimen labeling, including patient name or unique patient identifier and, when appropriate, specimen source. (a)(4) Specimen storage and preservation. (a)(5) Conditions for specimen transportation. (a)(6) Specimen processing. (a)(7) Specimen acceptability and rejection. (a)(8) Specimen referral. This STANDARD is not met as evidenced by: Based on record review and interview with the Senior Director of Clinical Development (SDCD), the laboratory failed to follow established specimen processing policies and procedures for 21 of 467 dermatopathology microscopic examinations performed from 10/23/2024 to 01/15/2026. Findings include: 1. The laboratory's Laboratory Procedure stated "The specimen is given an accession number and logged in the Mohs logbook. Patient name, date, site, diagnosis, stage or layer and number of quadrants per specimen layer." 2. On the day of survey, 01/15/2026 at 9:38 am, review of the laboratory's accession logs revealed the laboratory failed to document the following information for 21 of 467 specimens: - Date - Surgical site - Sections per stage 3. The SDCD confirmed the above findings on 1/15/2026 at 11:35 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 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 -- 2 of 5 -- maintained when the laboratory was closed for 434 of 449 days from 10/23/2024 to 01 /15/2026. Findings include: 1. On the day of survey, 01/15/2026, at 10:35 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 434 of 449 days from 10/23/2024 to 01/15/2026 when the laboratory was closed. 3. The laboratory performed 350 dermatopathology microscopic examinations in 2025 (CMS 116, estimated annual volume, dated 01/14 /2026). 4. The SDCD confirmed the above findings on 1/15/2026 at 11:35 am. 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 record review, lack of documentation, and interview with the Senior Director of Clinical Development (SDCD), the laboratory failed to ensure all laboratory established maintenance procedures were performed and documented for 1 of 1 microscopes used to perform dermatopathology microscopic examinations from 10/23/2024 to 01/15/2026. Findings include: 1. The laboratory's Microscope procedure stated, "Change bulbs as needed and have regular annual service and PM contracts performed." 2. On the day of survey, 01/15/2026 at 9:38 am, review of the laboratory's maintenance records revealed the laboratory failed to document annual preventative maintenance procedures performed from 10/23/2024 to 01/15/2026 for the following 1 of 1 microscope used to perform dermatopathology microscopic examinations: - Olympus BX40F4 3. The laboratory performed 350 dermatopathology microscopic examinations in 2025 (CMS 116, estimated annual volume, dated 01/14 /2026). 4. The SDCD confirmed the above findings on 1/15/2026 at 11:35 am. D5601 HISTOPATHOLOGY CFR(s): 493.1273(a)(f) (a) As specified in 493.1256(e)(3), fluorescent and immunohistochemical stains must be checked for positive and negative reactivity each time of use. For all other differential or special stains, a control slide of known reactivity must be stained with each patient slide or group of patient slides. Reactions of the control slide with each special stain must be documented. This STANDARD is not met as evidenced by: Based on review of laboratory policy, quality control (QC) logs, lack of documentation, and interview with the Senior Director of Clinical Development (SDCD), the laboratory failed to document a control slide of known reactivity to ensure acceptable staining characteristics of Hematoxylin & Eosin (H&E) stains for 1 of 18 days when dermatopathology microscopic slides were examined from 10/23 -- 3 of 5 -- /2024 to 01/15/2026. Findings include: 1. The laboratory's Quality Assurance for Routine Stains procedure stated "A quality control slide will be run each day the lab operates. Each QC will be logged on the stain QC chart." 2. On the day of survey, 01 /15/2026 at 10:09 am, a review of the laboratory's QC staining logs revealed the laboratory failed to document a control slide of known reactivity to ensure acceptable H&E staining characteristics for the following 1 of 18 days when dermatopathology microscopic slides were examined from 10/23/2024 to 01/15/2026: - 08/14/2025 3. Review of the laboratory's Mohs accession logs revealed that the laboratory performed 19 dermatopathology slide examinations on 08/14/2025. 4. The SDCD confirmed the above findings on 1/15/2026 at 11:35 am. D5781

Summary Statement of Deficiencies 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 (Mohs maps) 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 patient test reports from 05/20/2024 to the date of the survey. Findings include: 1. On the day of survey, 10/23/2024 at 09:20 am, review of 2 of 2 patient test reports (Mohs maps) revealed the laboratory failed to ensure the addition of the address of the laboratory where MOHS microscopic slides were examined from 05/20/2024 until 10/11/2024. 2. The DTC confirmed the above findings on 10/23/2024 at 09:20 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. 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 review of laboratory QA records 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 the quality as they occur from June 2024 to October 2024. Findings include: 1. On the day of survey 10/23/2024 at 9:18 am, review of the Monthly QA Assurance Checklists revealed that the LD failed to provide checklists for 5 out of 6 months in 2024: - June 2024 - July 2024 - August 2024 - September 2024 - October 2024 2. The laboratory performed 200 MOHS microscopic examinations in 2024 (CMS 116 annual volume) 3. The DTC confirmed the findings above on, 10/23/2024 at 9:18 am. -- 2 of 2 --