Pennsylvania Dermatology Partners-Pottstown

Summary Statement of 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 lack of documentation, laboratory's Proficiency Testing manual review, and interview with the director of training and compliance (DOTC), the laboratory failed to verify twice annually the accuracy of dermatopathology microscopic examinations performed in 2022. Findings include: 1. The laboratory's Proficiency Testing manual stated, "Semi-annually, the tech or risk manager will send five cases containing the original slides, label it with only the surgical case number, and send it for a microscopic examination by a Board Certified Dermatopathologist. No differential diagnosis will be offered with the specimen. The slide may be labeled "Proficiency Test" by the sending laboratory for the records of the reference laboratory." 2. On the day of survey, 04/16/2024 at 11:00 am, the laboratory could not provide documentation of the semiannual verification of accuracy of dermatopathology microscopic examinations performed in 2022. 3. The DOTC confirmed the findings above on 04/16/2024 at 12:30 pm. 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. This STANDARD is not met as evidenced by: 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 -- Based on observation of the laboratory, procedure review, and interview with the director of training and compliance (DOTC), the laboratory failed to perform and document preventative maintenance (PM) on 1 of 1 cryostat used for dermatopathology macroscopic examinations performed from 07/2023 to the day of the survey. Findings include: 1. The laboratory's cryostat procedure states, "Preventative maintenance and grounding checks are done and documented annually." 2. On the day of survey, 04/16/2024 at 12:08 pm, during observation of the laboratory the surveyor observed on the sticker that PM on 1 of 1 cryostat (AVANTIK QS 11) was due in 07/2023. 3. According to the CMS 116 the laboratory performed 900 dermatopathology macroscopic examinations in 2023. 4. The DOTC confirmed the findings above on 04/16/2024 at 12:30 pm. -- 2 of 2 --

Summary Statement of Deficiencies 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. This STANDARD is not met as evidenced by: Based on observation of the laboratory and interview with the Laboratory Manager, the laboratory failed to establish a maintenance policy to assess the maintenance /function for 1 of 1 Fisher Scientific digital thermometer used to monitor the room temperature and humidity for Dermatopathology laboratory from January 9, 2019 to the day of survey. Findings Include: 1. On the day of survey, 07/21/2022 at 13:13 PM, the laboratory failed to provide a maintenance policy for 1 of 1 Fisher scientific thermometer (S/N 170015175). 2. An expiration date of 09/01/2019 was observed on the sticker posted on the Fisher Scientific digital thermometer. 3. Laboratory manager confirmed the findings above on 07/21/2022 at 13:25 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 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 proficiency testing records and interview with the laboratory supervisor, the laboratory failed to verify at least twice annually accuracy (blind test) of Mohs microscopic examinations for 1 of 1 testing personnel (laboratory director) in 2018 and 2019. Findings Include: 1. The Proficiency Testing Policy states, "Dermatologists will circulate slides within the Pennsylvania Dermatology Partners, PC group and assess slides in a blind test". 2. On the day of survey, 02/10/2020, the laboratory could not provide documentation of blind testing conducted at least twice annually for 1 of 1 testing personnel who performed Mohs microscopic examinations in 2018 and 2019. 3. Approximately 508 Mohs microscopic examinations were analyzed in 2019. 4. The laboratory supervisor confirmed the findings above on 02/10 /2020 around 9:15 am. *** Repeat Deficiency 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 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 Interview with the Histotechnologist and review of peer review records, the laboratory failed to verify the accuracy of the microscopic examination for Histopathology (Mohs micrographic surgery) at least twice annually during 2017 as required for tests not included in subpart I. Findings Include: 1. On the date of survey, 03/28/2018, review of Mohs micrographic surgery peer review records revealed that no evaluation and verification activity was performed for Histopathology in 2017. 2. About 410 mohs specimen were prepped in 2017. 3. The Histotechnologist confirmed that no evaluation and verification activity was performed for Histopathology in 2017 on 03/28/2018 around 10:00 am. D5401 PROCEDURE MANUAL 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 review of the laboratories procedure manuals, observation and interview with Histotechnologist, the laboratory failed to have a written Mohs procedure manual available from the start of patient testing, April 25, 2017 to March 26, 2018. Findings 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 -- include: 1. On the day of survey, 03/28/2018, review of the laboratories procedure manual revealed that the Mohs procedure manual was signed by the director on 03/27 /2018. 2. The laboratory started patient testing on April 25, 2017. 3. Interview with the Histotechnologist on 03/28/2018 around 9:30 am, confirmed the laboratory did not have a procedure manual onsite from April 25, 2017 to March 26, 2018. 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 the review of Patient Test Reports and interview with a Histotechnologist, the laboratory failed to include the correct address on the Mohs maps of Patient test report from 2017 to the date of survey. Finding Include: 1. On the date of survey, 03 /28/2018, 30 of 30 patient Mohs maps reviewed at the time of inspection did not include the correct address of where the Mohs surgery took place. 2. The address on the Mohs maps is for the location - 2913 Windmill Road, Suite 7. Sinking Springs, PA 19608-1680 2. About 410 specimen were prepped in 2017. 3. About 90 specimen were prepped in 2018. 3. The Histotechnologist confirmed the findings above on 03/28 /2018 around 9:15 am. -- 2 of 2 --