Advanced Dermatology Of Pennsylvania

Summary Statement of Deficiencies D5449 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(ii)(g) Unless CMS Approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing, the laboratory must-- At least once a day patient specimens are assayed or examined perform the following for-- Each qualitative procedure, include a negative and positive control material; (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on lack of quality control (QC) records and interview with testing personnel (TP) #6, the laboratory failed to include a positive and negative control each day of patient testing for Potassium Hydroxide (KOH) and Scabies microscopic examinations performed from 06/07/2022 to the day of survey. Findings include: 1. The laboratory's Wet Prep Procedures for KOH and Scabies include having available for testing personnel a reference containing photographs for comparison with patient specimens and checking the Internal Control Picture Verification box on the KOH and Parasitology Log. 2. On the day of survey, 03/07/2024 at 10:16 am, the laboratory could not provide documentation of the positive and negative control performed every day of patient testing from 06/07/2022 to 03/07/2024. 3. The laboratory performed 66 KOH and 9 scabies microscopic examinations from 06/07/2022 to 03/07/2024. 4. TP #6 confirmed the findings above on 03/07/2024 at 11:28 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 D5415 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(c) Reagents, solutions, culture media, control materials, calibration materials, and other supplies, as appropriate, must be labeled to indicate the following: (1) Identity and when significant, titer, strength or concentration. (2) Storage requirements. (3) Preparation and expiration dates. (4) Other pertinent information required for proper use. This STANDARD is not met as evidenced by: Based on observation of the laboratory and interview with the Office Manager (OM), the laboratory failed to ensure 5 of 5 bottles of tissue marking inks for dermopathology were labeled to indicate their received and expiration dates at the day of survey. Findings Include: 1. On the day of survey, 06/07/2022, observations of the laboratory revealed, the laboratory did not label the received and expiration dates of the following 5 of 5 tissue marking ink bottles: - Green: Lot A801608 exp 5-26-2026 - Blue: Lot A806348 exp 1-10-2026 - Yellow: Lot A806355 exp 1-10-2026 - Black: Lot A806357 exp 1-10-2026 2. The OM confirmed the finding above on 06/07/2022 at 12:40 p.m. D5449 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(ii)(g) Unless CMS Approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing, the laboratory must-- At least once a day patient specimens are assayed or examined perform the following for-- Each qualitative procedure, include a negative and positive control material; (g) The laboratory must document all control procedures performed. 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 quality control records and interview with the Office Manager (OM), the laboratory failed to document Quality control (QC) each day of patient testing for Potassium Hydroxide KOH and Scabies microscopic examinations in 2021. Findings include: 1. On the day of survey, 06/07/2022, review of KOH and scabies QC records revealed, that physicians performing KOH and scabies examination were not documenting QC each day of patient testing in 2021. 2. The laboratory performed 16 KOH and 2 scabies microscopic examinations in 2021 3. The OM confirmed the finding above on 06/07/2022 around 14:45 pm. -- 2 of 2 --

Summary Statement of Deficiencies 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 the laboratory's competency assessment for testing personnel procedure and interview with the regional vice president and the office manager, the laboratory failed to assess the competency of 2 of 2 testing personnel (TP) who performed KOH and wet mount microscopic procedures from 2018 to the day of survey. Findings Include: 1. The Competency Assessment for Testing Personnel procedure, 4. Policy states, " Laboratories that perform moderate to high complexity testing participate in competency assessment of all testing personnel that include six procedures". 2. On the day of survey, 01/14/2020, the laboratory could not provide competency assessment documentation for 2 of 2 TP who performed KOH and Wet mounts from 07/017/2018 to 01/14/2020. 3. The regional vice president and the office manager confirmed the findings on 11/14/2020 around 9:30 am. ***KOH = Potassium Hydroxide 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 peer review records and interview with the regional vice president 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 -- and the office manager, the laboratory failed perform at least twice annually the accuracy of KOH and Wet prep microscopic examination procedures in 2018 and 2019. Findings Include: 1. On the day of survey, 01/14/2020, review of peer review records revealed, the laboratory did not perform at least twice annually the accuracy of KOH and Wet preps examination procedures in 2018 and 2019. 2. The regional vice president and the office manager confirmed the above findings on 01/14/2020 around 9:45 am. ***KOH = Potassium Hydroxide 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 room temperature thermometer, interview the regional vice president and the office manager, the laboratory failed to perform maintenance/ calibration on 1 of 1 fisher scientific traceable thermometer in 2019. Findings Include: 1. On the date of survey, 01/14/2020, while on tour of the laboratory, 1 of 1 fisher scientific traceable thermometer (S/N: 170600121) observed in use to monitor the room temperature of the laboratory, was due for maintenance/ calibration on 08/22/2019. 2. The regional vice president and the office manager confirmed the above findings on 01/14/2020 around 10:50 am. -- 2 of 2 --

Summary Statement of Deficiencies D6072 TESTING PERSONNEL RESPONSIBILITIES CFR(s): 493.1425(b)(3) Each individual performing moderate complexity testing must adhere to the laboratory's quality control policies, document all quality control activities, instrument and procedural calibrations and maintenance performed. This STANDARD is not met as evidenced by: Based on review of laboratory KOH Log, Internal Control Picture Verification record and interview with the office manager, the laboratory testing personnel (TP) failed to record KOH quality control (QC) in July 2018. Findings include: 1. The July 2018 laboratory KOH Log reads as follows: Date Patient Provider Internal Control Picture Verification (QC) 07/05 1 TP # 2 Blank 07/09 2 TP # 2 Blank 07/10 3 TP # 2 Blank 2. TP # 2 tested all (3 of 3) KOH specimens. 3. TP # 2 documented no (3 of 3) QC on KOH Log sheet. 4. TP # 2 reported all 3 KOH results in July 2018. 5. The office manager confirmed above findings on 07/17/2018 at 12:30 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 --