Abington Dermatology Assoc

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 procedure manuals and interview with the Histology Technologist (HT), the laboratory failed to establish a competency assessment procedure to assess 1 of 1 testing personnel (TP) who performs MOHS micrographic surgery slide examinations from 01/23/2023 to the day of survey. Finding includes: 1. On the day of the survey 01/23/2025 at 9:25 am the laboratory failed to provide a policy to assess the competency of 1 of 1 TP (CMS 209 TP#1) performing MOHS micrographic surgery slide examinations from 01/23/2023 to 01/23 /2025. 2. The HT confirmed the findings above on 01/23/2025 at 9:50am. **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 observation of the laboratory, lack of maintenance records, and interview with the histology technician (HT), the laboratory failed to perform and document the maintenance and function checks as defined by the manufacturer for 1 of 1 VWR Traceable thermometer/humidity monitor used for monitoring room temperature and 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 -- humidity in the histopathology laboratory from 01/23/2023 to the day of the survey. Findings include: 1. On the day of the survey, 01/23/2025 at 09:50 am, observation of the laboratory revealed the following thermometer used for room temperature and humidity monitoring in the histopathology laboratory were due for maintenance: - 1 of 1 VWR Traceable Thermometer due 10/19/2023 2. The laboratory failed to provide maintenance/functions checks records for the VWR Traceable thermometer 10/19 /2023 to 01/23/2025. 3. The laboratory performed 1000 histopathology examinations in 2024 (CMS 116, estimated annual volume). 4. The HT confirmed the findings above on 01/23/2025 at 09:50 am. D6093 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(5) (e)(5) Ensure that the quality control and quality assessment programs are established and maintained to assure the quality of laboratory services provided and to identify failures in quality as they occur; This STANDARD is not met as evidenced by: Based on review of laboratory's Quality Assessment (QA) records, and interview with the Histology Technologist (HT), the laboratory director (LD) failed to ensure QA programs were maintained to assure the quality of laboratory services and to identify failures in quality as they occur for 2 out of 5 months from August 2023 to December 2023. Findings include: 1. The laboratory's Quality Assurance policy states: " Monthly the nurse or tech will check off the Monthly Quality Assurance Checklist. The lab director will also review and sign off the checklist monthly." 2. On the day of survey 01/23/2025 at 9:25 am, review of the Monthly QA Assurance Checklists revealed the LD failed to ensure QA was maintained for the following 2 months from August 2023 to December 2023 when MOHS micrographic surgery slide examinations were performed: - October 2023 - December 2023 3. The HT confirmed the findings above on 01/23/2025 at 9:50 am. -- 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 procedure manuals and interview with the practice manager, the laboratory failed to establish a competency assessment procedure to assess 1 of 1 testing personnel (TP) who performed MOHS micrographic surgery slide examinations from 11/18/2020 to 11/03/2022. Findings include: 1. On the day of survey, 01/23/2023 at 10:07 am, the laboratory failed to provide a policy to assess the competency of 1 of 1 TP performing MOHS micrographic surgery slide examinations from 11/18/2020 to 11/03/2022. 2. The practice manager confirmed the findings above on 01/23/2023 around 10:52 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 1 --

Summary Statement of Deficiencies 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 records and interview with the mohs laboratory manager and business manager, the laboratory failed to retain quality control and patient test records (including instrument printouts) and records documenting all analytic systems activities specified in 493.1252 through 493.1289 from 07/18/2018 to 11/18/2020. Findings include: 1. On the day of survey, 11/18/2020, review of the mohs analytical system records revealed, the following documents were missing from 07/18/2018 to 11 /18/2020. - Quality control records for H&E stain checks. - Microtom HM 525 temperature records. - Microscope maintenance documents from. - Automatic stain maintenance records from. 2. The mohs laboratory manager and business manager confirmed the findings above on 11/18/2020 around 10:15 am. 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 procedure manuals and interview with the mohs laboratory manager and business manager, the laboratory failed to establish a 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 -- complete competency assessment procedure to assess the competency of 2 of 4 technical consultants in 2018, 2019 and 2020. Findings include: 1. On the day of survey, 11/18/2020, the laboratory failed to provide a complete written policy to assess the competency for 2 of 4 TC (personnel #4 and #5), listed on the CMS Testing Personnel form 209 as TC. 2. Personnel #4 and #5 reviewed physician peer reviews for KOH and scabies microscopic examinations in 2018, 2019 and 2020. 3. Personnel #4 and #5 were not assessed for competency for their TC roles in 2018, 2019 and 2020. 3. The mohs laboratory manager and business manager confirmed the finding above on 11/18/2020 around 9:15 am. *** KOH = Potassium Hydroxide. D5301 TEST REQUEST CFR(s): 493.1241(a) The laboratory must have a written or electronic request for patient testing from an authorized person. This STANDARD is not met as evidenced by: Based on review of laboratory records and interview with the The mohs laboratory manager and business manager, the laboratory failed to document test requests for 3 of 7 patient specimen analyzed for Potassium Hydroxide (KOH) and scabies microscopic examinations performed in 2019. Findings include: 1. On the day of survey, 11/18/2020, review of KOH and scabies microscopic examinations test requests revealed, the laboratory did not document test requests for 3 of 7 patients (1 of 5 for KOH and 1 of 2 for scabies) for KOH and scabies microscopic examinations performed in 2019. 2. The mohs laboratory manager and business manager confirmed the finding above on 11/18/2020 around 09:20 am. 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 review of Potassium Hydroxide (KOH) and scabies microscopic examinations quality control (QC) records, and interview with the mohs laboratory manager and business manager, the laboratory failed to document QC procedures performed for 7 of 7 patient specimens examined for KOH and scabies microscopic examinations performed from 2019 to the date of survey. Findings Include: 1. On the day of survey, 11/18/2020, review of KOH and scabies microscopic examination records revealed, the laboratory did not document QC procedures performed each day of patient testing for KOH and scabies microscopic examinations performed from 01 /01/2019 to 11/18/2020. 2. In 2019, the following Microscopic Examination were analyzed: - 4 KOH examination. - 2 Scabies examination. 3. In 2020, the following Microscopic Examination were analyzed. - 1 KOH examination. 4. The mohs laboratory manager and business manager confirmed the finding above on 11/18/2020 around 09:00 am. -- 2 of 3 -- D6021 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(5) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(5) Ensure that quality assessment programs are established and maintained to assure the quality of laboratory services provided. This STANDARD is not met as evidenced by: Based on review of Potassium hydroxide (KOH) and scabies microscopic examination procedures and interview with the mohs laboratory manager and the business manager, the laboratory director failed to assure that quality assessment programs were maintained to assure the quality of laboratory services provided for KOH and scabies microscopic examinations performed form 07/09/2018 to the day of survey. 1. Both the Scabies diagnosis by skin scraping and Fungal Infection by diagnosis by sin scraping standard operating procedures state, "Quality assessment (QA) will be conducted twice annually to conform the diagnosis by the clinical consultant. Scraping will be sent to an outside laboratory (LabCorp, Quest)". "The findings will be compared by the laboratory director and documented". 2. On the day of survey, 11 /18/2020, the laboratory could not provide documentation of twice annual QA review for KOH and scabies microscopic examinations performed from 2018, 2019 and 2020. 3. The mohs laboratory manager and the business manager confirmed the findings above on 11/18/2020 around 9:17 am. -- 3 of 3 --