Bryn Mawr Medical Specialists Association

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 Testing Personnel (TP)#2, the laboratory failed to perform and document maintenance on the 1of 2 Cryostat instruments from 04/08/2021 to date of survey. Findings Include: 1. Observation of the laboratory on 05/16/2023 at 09:47 am, revealed maintenance for the Leica CM 1510s cryostat was due in November of 2021 and the laboratory did not perform and document maintenance at least yearly as specified by the manufacturer. 2. Interview with TP #2 confirmed the Leica CM 1510s cryostat had not been used and was kept as a backup instrument only. 3. TP #2 confirmed findings above on 05/16/2023 around 10:00am . 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 Testing Personnel (TP)#2, the Technical Supervisor (TS) failed to include assessment of test performance in the competency evaluation of 1 of 2 testing personnel who 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 -- gross examinations and specimen inking of frozen sections from 04/08/2021 through date of survey. Findings include: 1. On the day of the survey 05/16/2023 at 9:34am, review of competency assessments 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 04/08/2021 to 05/16/2023. 2. The laboratory reported an annual test volume of 2505 for Histopathology. (CMS-116) 3. TP #2 confirmed the above findings on 05/16/2023 around 10:00am. -- 2 of 2 --

Summary Statement of Deficiencies D5291 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and, when indicated, correct problems identified in the general laboratory systems requirements specified at 493.1231 through 493.1236. This STANDARD is not met as evidenced by: Based on review of laboratory quality assurance-the competency policy, Mohs Tech performance validation record, and interview with the laboratory testing personnel (TP) #6, the laboratory failed to keep tracking Mohs Tech problem solving skills in 2018. Findings include: 1. The laboratory Mohs Lab Tech Competency policy, the laboratory director signed on 04/09/2018, states "To insure continued testing consistency of the Lab Tech, each of these following requirements of competency must be accounted for ....assessment of problem solving skills...." 2. The 08/2018 Mohs Tech^ performance validation* reads as follows: Competency Assessment (1). Consistent quality of staining? Yes (2). Obtain full epidermis margins? Yes (3). Track specimen throughout procedures? Yes (4). Maintain storage of slides and logs? Yes ^Mohs Tech is also TP #6 *Total 4 competency assessments 3. Of these assessments, non (4 of 4) evaluated problem solving skills. 4. The laboratory director signed off above competency assessments on 08/30/2018. 5. The laboratory had no