North County Dermatology Clinic Pa

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at North County Dermatology Clinic PA on 07/10/2025 - 07/11/2025. The laboratory is not in compliance with 42 CFR Part 493, Requirement for Laboratories. The following Conditions were cited: D5200 493.1230 Condition: General Laboratory Systems D6076 493.1441 Condition: Laboratory Director 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 observation, record review, and staff interview, the laboratory failed to establish and maintain chemicals in a manner to ensure protection from hazards by failing to store 100% Reagent Alcohol in a flammable liquids storage area and storing incompatible reagents, bleach (sodium hypochlorite) and 10% Formalin Fixative together. Findings included: 1. A tour of the laboratory was conducted beginning at 10: 00 a.m. on 07/10/2025. 100% Reagent Alcohol was observed stored on a shelf in a regular cabinet, bleach was observed stored next to 10% Formalin Fixative. No flammable storage cabinet was observed in the lab. 2. Interview with Testing Person (TP)) #C during the tour confirmed the above. 3. The Safety Data Sheet (SDS) for 100% Reagent Alcohol, with a revision date of 07/15/2015 was reviewed. The SDS indicated "Highly flammable liquid and vapor" and "Store in an approved Flammable Liquids storage area." 4. The SDS for bleach, with a revision date of 08/17/2018, was reviewed. The SDS had a pictogram reflecting the chemical is corrosive. The SDS stated "Store away from other materials." The pH was documented as 12.1, which is a strong base. 5. The SDS for 10% Formalin Fixative was reviewed. The SDS had a pictogram reflecting the chemical is corrosive. The SDS stated the reagent was 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 -- incompatible with "Bases" and hazardous decomposition products included "formaldehyde, carbon monoxide and carbon dioxide." D5200 GENERAL LABORATORY SYSTEMS CFR(s): 493.1230 Each laboratory that performs nonwaived testing must meet the applicable general laboratory systems requirements in 493.1231 through 493.1236, 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 general laboratory systems and correct identified problems specified in 493.1239 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: Based on record review and interview, the laboratory failed to ensure continuing compliance with the requirements for general laboratory systems with previously identified non-compliance (07/28/2023) regarding verifying the accuracy of slide interpretation for the subspecialty of Histopathology for one (2024) of two years (2023, 2024) reviewed. (See D5217) 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 interview, the laboratory failed to verify the accuracy twice annually for one (2024) of two years reviewed (2023-2024) for Testing Person (TP) #B for testing performed in the subspecialty of Histopathology. This deficiency was previously cited at the 07/28/2023 recertification. Findings included: 1. The

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at North County Dermatology Clinic PA on 07/25/23 to 07/28/23. The laboratory is not in compliance with 42 CFR Part 493, Requirements for Laboratories. The following is a description of the standard level 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 record review and interview with the Laboratory Director, the laboratory failed to ensure the accuracy for twice a year testing for parasitology (Scabies) for 4 (#A, #D, #E, and #G) out of 5 Testing Personnel ( #A, #D, #E, #F, and #G) for two out of two years (2021 - 2023) and failed to ensure the accuracy for twice a year testing for histopathology for one out one Testing Personnel ( #B) for two out of two years (2021 - 2023). Findings included: Record review of the "Scabies" Log that included columns titled "Primary Reader Initials" and "Initial for QA if agree" revealed: Testing Personnel (TP) #A had verification of accuracy performed one time in 2021 (12/19/21) and one time in 2022 (12/27/22), TP #D had verification of accuracy performed one time in 2021 (12/19/21) and one time in 2022 (1/19/22), and TP #E and TP #G had no documentation for verification of accuracy performed in 2021 and 2022. Record review of the "TC/PC Quality Assurance Peer Review Requisition" for histopathology revealed TP #B had no peer review or verification of accuracy performed in 2021 or 2022. On 07/25/2023 at 1:10 PM, the Laboratory Director confirmed the twice annual verification of accuracy for scabies and histopathology had not been performed for TP #A, #B, #D, #E, and #G. D5401 PROCEDURE MANUAL 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 -- CFR(s): 493.1251(a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: Based on observation, record review, and staff interview, the laboratory failed to follow written procedures for the Microscope Protocol and the Cryostat and Microtome Use Protocol for two out of two years (2022-2023) reviewed. Findings included: On 07/25/2023 at 10:30 AM, observation revealed the Olympus BX41 microscope had a service sticker that documented service was performed and due 03 /21 and the American Optical microscope had a service sticker documenting service was due 11/22. Record review of the microscope service field report for the Olympus BX41 clarified that the service was performed on 03/01/21 and was not due again until 03/01/22. A review of the laboratory's procedure titled "Equipment Quality Control Form 1: Microscope Protocol" revealed the microscope state and ocular eyepieces are to be cleaned every year, and the ocular micrometer is to be calibrated every year. On 07/25/23 at 1:15 PM, the Laboratory Director confirmed that both microscopes had not been maintained in accordance with the protocol and service stickers. Record review of the laboratory's cryostat logs revealed the laboratory had not documented the cryostat's inside chamber temperature or cryostat and microtome maintenance. Record review of the laboratory's procedure "Equipment Quality Control Form 3: Cryostat and Microtome Use Protocol" revealed

Summary Statement of Deficiencies 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 observation, record review, and interview with the General Supervisor, the laboratory failed to dispose of Formalin per the material safety data sheets (MSDS) for an undetermined amount of time. Findings Included: 1. Tour of the laboratory on 12/11/2018 at 10:00 AM revealed multiple containers labeled 10% Formalin Fixative and a drum that was labeled xylene waste. (Photographic evidence was obtained). 2. Review of the Material Safety Data Sheet (MSDS) for Forrmalin revealed the waste disposal method was to "check with your local waste authorities" and "Do not dispose of in drains". 3. On 12/11/2018 at 11:00 AM, the General Supervisor confirmed that with the exception of xylene, chemicals were dumped down the drain with copious amounts of water. 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 interview with the General Supervisor, the laboratory failed to ensure the accuracy of histology testing twice a year for one (2018) of two years reviewed (2017 - 2018). Findings Included: 1. Review of Histology Peer 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 -- Review revealed this peer review had been performed twice for 2017 and once for 2018, 02/13/2018. The laboratory did send histology specimens to another laboratory for peer review in June of 2018 (06/2018). The other laboratory failed to complete the Peer Review form the laboratory sent with the histology specimens and instead sent the results in the form of a patient report. The laboratory failed to document if the original results agreed with the other laboratory's results. 2. Interview on 12/11/2018 at 12:45 p.m. with the General Supervisor, confirmed that the laboratory failed to document the results of the 06/2018 peer review. 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, record review, and interview with the Head Nurse, the laboratory failed to ensure the potassium hydroxide was removed from use after the expiration date for 2 out of 2 years (2017-2018). Findings Included: 1. Observation on 12/11/2018 at approximately 10:45 AM revealed a bottle of potassium hydroxide with an expiration date of 02/13/2014, with no other bottles available to be used for testing. Photographic evidence was obtained. 2. Review of the KOH test logs (2017-2018) revealed that potassium hydroxide testing had been performed using the expired potassium hydroxide. 3. Interview on 12/11/2018 at 10:45 AM with the Head Nurse, confirmed that the potassium hydroxide had expired on 02/13/2014. D5475 CONTROL PROCEDURES CFR(s): 493.1256(e)(3)(g) (e) For reagent, media, and supply checks, the laboratory must do the following: (e) (3) Check fluorescent and immunohistochemical stains for positive and negative reactivity each time of use. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on record review, observation, and interview with the General Supervisor, the laboratory failed to test a positive and negative control for immunohistochemical stains and to document the results as positive or negative for 2 out of 2 years reviewed (2017-2018) Findings included: 1. Record review of the quality control log revealed results for special stains was recorded as "good" for 2017 and 2018. 2. Observation on 12/11/2018 at 1:00 PM of immunohistochemical quality control slides that were pulled for the same day as requested patient slides and reports revealed that the laboratory was only preparing a quality control slide and not a positive and negative control slide. 3. Interview on 12/11/2018 at 11:45 AM with the General Supervisor, confirmed the laboratory was not performing positive and negative quality controls for immunohistochemical stains. -- 2 of 2 --