Dermatology Physicians Inc

Summary Statement of Deficiencies D0000 A routine recertification survey was conducted by the Pennsylvania State Agency at Dermatology Physicians Inc on 10/09/2025. The laboratory was found out of compliance with the following condition: 493.1250 Condition: Analytic systems. D5400 ANALYTIC SYSTEMS CFR(s): 493.1250 Each laboratory that performs nonwaived testing must meet the applicable analytic systems requirements in 493.1251 through 493.1283, 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 analytic systems and correct identified problems as specified in 493.1289 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: Based on observation of the laboratory, record review, and interview with the Laboratory Supervisor (LS), the laboratory failed to meet applicable analytic systems requirements in 493.1251 through 493.1283 from 11/01/2024 to date of survey. Refer to D5417. 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 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 -- reports. This STANDARD is not met as evidenced by: Based on lack of documentation, and interview with the Lab Supervisor (LS), the laboratory failed to monitor and document room temperature and humidity to ensure operating conditions were met for 1 of 1 microscopes used to perform Potassium Hydroxide (KOH) microscopic slide examinations from 9/15/2023 to 10/09/2025. Findings Include: 1. On the day of survey, 10/09/2025 at 09:40 am, the laboratory failed to provide documentation for monitoring room temperature (laboratory's acceptable range 65 - 72 degrees Fahrenheit) and relative humidity (laboratory's acceptable range 0 - 60%) to ensure operating conditions were met for the following instrumentation used to perform KOH microscopic slide examinations from 9/15/2023 to 10/09/2025: - 1 of 1 Omega microscope (s/n 0820592) 2. The laboratory performed 5 KOH microscopic slide examinations in 2024 (CSM 116, estimated annual volume, dated 10/09/2025). 3. The LS confirmed the findings above on 10/09/2025 at 10:27 am. 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 observation of the laboratory, record review, and interview with the Laboratory Supervisor (LS), the laboratory failed to ensure that 1 of 1 reagent used to perform Potassium Hydroxide (KOH) microscopic slide examinations was not used beyond its expiration date from 11/01/2024 to date of survey. Findings include: 1. On the day of the survey 10/09/2025 at 09:37 am, observation during the laboratory tour revealed the following 1 of 1 expired reagents currently being used to perform KOH microscopic slide examinations from 11/01/2024 to 10/09/2025: - 1 opened bottle of Delasco 20% KOH with DMSO (Lot #K21AB, expired 10/31/2024). 2. Review of the laboratory's "Quality Control of KOH Preparation" log revealed that 2 KOH Prep microscopic slide examinations were performed from 11/01/2024 to 10/09/2025. 3. The LS confirmed the findings above on 10/09/2025 at 10:27 am. **Repeat deficiency** D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) (a)(1) 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 review of the laboratory's Quality Control Policy for Laboratory Equipment, lack of documentation, and interview with the Laboratory Supervisor (LS), the laboratory failed to perform the preventative maintenance/function checks for 1 of 1 microscopes used for Potassium Hydroxide (KOH) microscopic slide examinations from 9/15/2023 to the day of survey. Findings Include: 1. The laboratory's "Quality -- 2 of 3 -- Control Policy for Laboratory Equipment, Microscopes" states, "Preventative maintenance will be done annually by Dolby Jamison [Biomed service provider]." 2. On the day of survey, 10/09/2025 at 9:40 am, the laboratory failed to provide maintenance/function check records of the annual preventative maintenance performed for the following 1 of 1 microscopes used from 9/15/2023 to 10/09/2025: - Omega microscope (s/n 0820592) 3. The laboratory performed 5 KOH microscopic slide examinations in 2024 (CSM 116, estimated annual volume, dated 10/09/2025). 4. The LS confirmed the findings above on 10/09/2025 at 10:27 am. -- 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 during the laboratory tour and interview with Testing Personnel (TP) #1, the laboratory failed to discard expired reagent used for tissue marking in Histopathology from 04/30/2023 to date of survey. Findings include: 1) On the day of survey 09/15/2023 at 9:45 am while touring the laboratory, the surveyor discovered a bottle of StatLab Violet tissue Marking Dye (Lot # 118665) with expiration date 04/30 /2023. 2) Interview with TP #1 on 09/15/2023 at 10:18 am confirmed the finding above. D6054 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 annually, after the first year. This STANDARD is not met as evidenced by: Based on lack of documentation and interview with Testing Personnel (TP) #1, the Technical Consultant (TC) failed to evaluate and document the competency assessment of 1 of 4 TP who performed Potassium Hydroxide (KOH) and Scabies microscopic examinations in 2021. Findings include: 1) On the day of survey 09/15 /2023 at 9:25 am, the laboratory could not provide documentation of the annual 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 -- competency assessment for TP #2 (CMS-209 Personnel #3) who performed KOH and Scabies microscopic examinations in 2021. 2) TP #1 confirmed the above findings on 09.15/2023 at 10:18 am. D6125 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(8)(v) The procedures for evaluation of the competency of the staff must include, but are not limited to assessment of test performance through testing previously analyzed specimens, internal blind testing samples or external proficiency testing samples. This STANDARD is not met as evidenced by: Based on review of Competency Assessment records and interview with Testing Personnel (TP) #1, the Technical Supervisor (TS) failed to evaluate the competency assessment through testing previously analyzed specimens, internal blind testing samples or external proficiency testing samples for 1 of 1 TP performing grossing and inking in Histopathology from 11/17/2021 to date of survey. Findings include: 1) On the day of survey 09/15/2023 at 9:30 am review of Competency Assessment records revealed the TS did not perform competency assessment through testing previously analyzed specimens, internal blind testing samples or external proficiency testing samples to evaluate grossing and inking for TP #1 (CMS-209 Personnel #2) from 11 /17/2021 to date of survey. 2) According to the CMS-116, the total annual volume for Histopathology is 11,862. 3) Interview with TP #1 on 09/15/2023 at 10:18 am confirmed the above findings. -- 2 of 2 --

Summary Statement of Deficiencies D3013 FACILITIES CFR(s): 493.1101(e) Records and, as applicable, slides, blocks, and tissues must be maintained and stored under conditions that ensure proper preservation. This STANDARD is not met as evidenced by: Based on lack of documentation, observation of the laboratory, and interview with the laboratory director (LD), the laboratory failed to monitor the room temperature of paraffin blocks storage to ensure proper conditions for preservation for 2019, 2020 and 2021. Findings include: 1. On the day of survey, 11/17/2021 at 10:40 a.m., the surveyor observed paraffin blocks were stored at room temperature in a office behind the laboratory. 2. The LD could not provide room temperature records for the office behind the laboratory from 11/17/2019 to 11/17/2021. 3. The laboratory could not provide a procedure for the storage of paraffin blocks. 4. The LD confirmed the findings above on 11/17/2021 at 10:45 a.m. 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. This STANDARD is not met as evidenced by: Based on review of laboratory quality control (QC) records and interview with the Laboratory Director (LD), the laboratory failed to retain QC records for Potassium Hydroxide (KOH) mycology and scabies microscopic examinations from 11/17/2019 to 07/21/2020. Findings include: 1. On the day of survey, 11/17/2021 at 09:35 a.m., 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 -- the laboratory could not to provide QC records for KOH mycology and scabies microscopic examinations performed from 11/17/2019 to 07/21/2020. 2. The LD confirmed the above finding on 11/17/2021 around 11:00 a.m. 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 review of competency assessment records and interview with the Laboratory Director (LD), the laboratory failed to assess 2 of 3 testing personnel (TP) for each assay in microbiology microscopic examinations performed for 2019, 2020, and 2021. Findings Include: 1. On the day of Survey 11/17/2021 at 09:15 a.m., review of the competency assessment records revealed, the forms used to document competency did not separate the two microscopic examinations (Potassium Hydroxide (KOH) Mycology and Scabies) for 2 of 3 TP from 11/17/2019 to the day of survey. 2. The LD confirmed the finding above on 11/17/2021 at 11:00 a.m. 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 review of the laboratory procedure manual, review of peer review records, and interview with the Laboratory director (LD), the LD failed to ensure that 3 of 3 Testing personnel (TP) performed the verification of accuracy of Potassium Hydroxide (KOH) for mycology and scabies microscopic examination in 2019, 2020, and 2021. Findings Include: 1. The laboratory's Peer Review Procedure manual states: "Each physician will review separately and then document their observation /interpretation. The forms are compared by the laboratory director." 2. On the day of survey, 11/17/2021 at 09:26, The Laboratory could not provide documentation of the verification of accuracy performed by 3 of 3 TP for KOH mycology and scabies from 11/17/2019 to the day of survey. 3. The LD confirmed the findings above on 11/17 /2021 around 11:00 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. (f) The laboratory must document all control procedures performed, as specified in this section. -- 2 of 3 -- This STANDARD is not met as evidenced by: Based on review of quality control (QC) slide evaluation records and interview with the Laboratory Director (LD), the laboratory failed to document a positive and negative reactivity every day of patient testing for 5 of 5 special stains performed in 2019, 2020, and 2021. Findings include: 1. On the day of survey 11/17/2021 at 10:15 a.m., review of special stains records revealed, that a positive and negative controls were not documented for Periodic acid-Schiff (PAS), Colloidal Iron, Gram, acid-fast bacteria (AFB), and Giemsa stains in 2019, 2020 and 2021. 2. The laboratory performed the following number of special stains: - From 11/17/2019 to 12/31/2019: 70 special stains. - From 01/01/2020 to 12/31/2020: 345 special stains. - From 01/01 /2021 to 11/17/2021: 508 special stains. 3. The LD confirmed the findings above on 11 /17/2021 around 11:00 a.m. -- 3 of 3 --

Summary Statement of Deficiencies 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 review of records and interview with the Hisotechnologist and a registered nurse (RN), the laboratory failed to retain histopathology slides for at least 10 years from the date of examination from 05/23/2009 to 05/23/2019. Findings Include: 1. On the day of survey, the laboratory could not provide histopathology slides read onsite from 05/23/2009 to 05/23/2019. 2. The Hisotechnologist and RN stated "all slides are kept at the main location located at 203 N. Lime Street, Lancaster PA, 17602 and or at Iron Mountain storage facility". 3. The laboratory was given till Wednesday 05/29 /2019 close of business day to send evidence of slide retention from 2018, 2017 and 2009. 4. On 5/30/2019 the surveyor did not receive any evidence, to show compliance. 5. On 05/30/2019 at 12:20 pm, the Hisotechnologist and RN were informed by email, that the laboratory would be cited for retention requirements. 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) 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 -- 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 the review of histopathology patient test reports and interview with the Hisotechnologist and a registered nurse (RN), the laboratory failed to include on 2 of 2 test reports reviewed at the time of survey, the location where Tissue Pathology slides were read from 08/22/2017 to the date of survey. Finding Include: 1. On the day of survey, 05/23/2019, a review of some test reports (2 of 2) revealed the test reports did not include the correct address where the slides were being read. 2. The final reports states, "Slides prepared @ 2106 Harrisburg Pike, Lancaster PA 17604 and Slides read @ 203 N. Lime street, Lancaster, PA". 3. According to the histotechnologist and the RN, on 05/23/2019 around 09:15 am the test reports did not reflect that slides were read at 2106 Harrisburg Pike, Lancaster PA 17604 location. D8103 BASIC INSPECTION REQUIREMENTS CFR(s): 493.1773(b)(c)(d) (b) General Requirements. As part of the inspection process, CMS or a CMS agent may require the laboratory to do the following: (b)(1) Test samples, including proficiency testing samples, or perform procedures. (b)(2) Permit interviews of all personnel concerning the laboratory's compliance with the applicable requirements of this part. (b)(3) Permit laboratory personnel to be observed performing all phases of the total testing process preanalytic, analytic, and postanalytic). (b)(4) Permit CMS or a CMS agent access to all areas encompassed under the certificate including, but not limited to, the following: (b)(4)(i) Specimen procurement and processing areas. (b)(4) (ii) Storage facilities for specimens, reagents, supplies, records, and reports. (b)(4)(iii) Testing and reporting areas. (b)(5) Provide CMS or a CMS agent with copies or exact duplicates of all records and data it requires. (c) Accessible records and data. A laboratory must have all records and data accessible and retrievable within a reasonable time frame during the course of the inspection. (d) Requirement to provide information and data. A laboratory must provide, upon request, all information and data needed by CMS or a CMS agent to make a determination of the laboratory's compliance with the applicable requirements of this part. This STANDARD is not met as evidenced by: Based on review of records and interview with the Hisotechnologist and registered nurse (RN), the laboratory failed to provide records, have data accessible and retrievable within a reasonable time frame during the inspection performed on 05/23 /2019. Finding Include: 1. On the day of survey, 05/23/2019, the histotechnologist and RN could not provide the records below during the inspection: a. 2018 and 2019 KOH, Scabies and Histopathology peer review records. b. Patient reports for KOH and scabies from 01/2018 and 07/2018. c. Patient reports for histology from 10/2018 and 02/2019. 2. The Hisotechnologist and RN stated "all documents were kept at the main location located at 203 N. Lime Street, Lancaster PA, 17602", the laboratory was given till Wednesday 05/29/2019 by close of business day to send records to the surveyor for review. 3. On 5/24/2019 at 10:12 am, the survey received records for KOH peer reviews, but 5 of 7 peer reviews were not circled to indicate where the review was performed and 2 of 7 peer reviews were circled for the 203 N. Lime street, -- 2 of 3 -- Lancaster PA 17602, not the 2106 Harrisburg Pike, Suite 314, Lancaster PA 17604 location. 4. On 5/30/2019 the surveyor did not receive additional information from the laboratory, to show compliance. 5. On 05/30/2019 at 12:20 pm, the Hisotechnologist and RN were informed by email, that the laboratory would be cited for retention requirements. ***KOH= Potassium Hydroxide -- 3 of 3 --