Dermatology Ltd, Chadds Ford

Summary Statement of Deficiencies 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 lack of documentation and interview with Testing Personnel (TP)#8, the laboratory failed to monitor and document room temperature and humidity to ensure operating conditions were met for 1 of 1 Leica DM 1000 LED microscope used for microbiology slide examinations performed from 05/18/2023 to the day of survey. Findings include: 1. The Leica DM 1000 LED microscope manufacturer's technical specifications for ambient operating temperatures are 15-35 degrees Celsius and maximum 80% relative humidity. 2. On the day of the survey, 04/03/2025, the laboratory failed to provide documentation of the monitoring of room temperature and humidity to ensure operating conditions were met for the 1 of 1 Leica DM 1000 LED microscope (s/n 377172) used when potassium hydroxide (KOH) microscopic examinations were performed from 05/18/2023 to 04/03/2025. 3. The laboratory performed 7 KOH microscopic examinations from 05/18/2023 to 04/03/2025. 4. TP #8 confirmed the above findings on 04/03/2025 at 2:02 pm. 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 --

Summary Statement of Deficiencies 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 Laboratory Director (LD), the Technical Supervisor (TS) failed to include assessment of test performance in the competency evaluation of 2 of 2 testing personnel who performed gross macroscopic examinations and specimen inking of frozen sections from 04/16 /2021 through date of survey. Findings include: 1. On the day of the survey 05/18 /2023 at 9:43am, review of Laboratory Personnel Competency Assessment Tracking form for Gross examinations and specimen inking of frozen sections, revealed the TS did not include assessment of test performance through previously analyzed specimens, internal blind testing samples or external proficiency testing samples from 04/16/2021 to 05/18/2023. 2. The laboratory reported an annual test volume of 2119 for Histopathology. (CMS-116) 3. LD confirmed the above findings on 05/18/2023 around 10:30am 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 --

Summary Statement of Deficiencies D6120 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(7)(8) (7) The technical supervisor is responsible for identifying training needs and assuring that each individual performing tests receives regular in-service training and education appropriate for the type and complexity of the laboratory services performed; (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 review of the laboratory competency assesment records and interview with the Technical Supervisor #1 (TS), the TS #1 failed to evaluate the competency assessment of 1 of 1 Testing Personnel (TP) who performed Mohs microscopic examinations from 10/26/2018 to the day of survey. Findings include: 1. On the day of survey 04/16/2021, the TS could not provide competency assessment record for 1 of 1 TP who performed Mohs microscopic examinations from 10/26/2018 to the day of survey. 2. The TS#1 confirmed the finding above on 04/16/2021 at 11:25 a.m. 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) 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 -- (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 laboratory records and interview with Testing Personnel #8 (TP8), The laboratory failed to provide Mohs microscopic examinations slides requested during the time of survey. Findings Include: 1. On the day of survey 04/16/2021, during the interview with TP 8, it was stated that the laboratory takes the slides to their other facility, located in Media, PA, after each day of patient testing for storage. 2. The laboratory could not retrieve Mohs Microscopic examinations slides upon request on 04/16/2021 at 12:00 p.m. 3. The TP#8 confirmed the findings above on 04 /16/2021 at 12:30 p.m. -- 2 of 2 --