Bryn Mawr Med Spec Asso Dpt Of Gastro

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 review of laboratory records, lack of documentation, and interview with the Laboratory Director (LD), the laboratory failed to monitor and document room temperature and humidity to ensure operating conditions were met for 1 of 1 Olympus BX45 Microscope used to perform histopathology slide examinations from 02/22 /2023 to the date of survey. Findings include: 1. The operating environment listed in the instruction manual for the Olympus BX45 microscope states: "ambient temperature: 5 C to 40C, maximum relative humidity: 80%." 2. On the date of the survey, 03/06/2025 at 9:30 am, the laboratory failed to provide documentation for monitoring room temperatures and humidity to ensure operating conditions were met for the 1 of 1 Olympus BX45 microscope (s/n 8K21167) used to perform histopathology slide examinations from 02/22/2023 to 03/06/2025. 3. The laboratory performed 6904 histopathology slide examinations from 02/22/2023 to 03/06/2025. 4. The LD confirmed the findings above on 03/06/2025 at 10:25 am. 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 D6094 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(5) The laboratory director must ensure that the 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 the lack of quality assurance (QA) documentation and an interview with the laboratory director (LD), the laboratory director failed to ensure a QA program was established and maintained to ensure the quality of services provided for the 1 of 1 specialty (histopathology) by the laboratory from 02/11/2021 to the date of survey. Findings include: 1. The laboratory's Quality Assessment policy stated that "The Laboratory Director or designee, will review the laboratory records bi-annual for the following quality factors: Patient Test Management, Quality Control, Proficiency Testing, Maintenance, Inventory, Communications, Complaints. The quality factors will be rated satisfactory or unsatisfactory on the Quarterly Assessment form." 2. On the date of survey, 02/22/2023 at 10:53 am, the laboratory could not provide documentation for the bi-annual review performed from 02/11/2021 to 02/22/2023. 3. The laboratory performed 477 and 628 microscopic examinations for histopathology in 2021 and 2022, respectively. 4. The LD confirmed the findings above on 02/22 /2023 around 11:15 am. D6127 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(9) The technical supervisor is responsible for evaluating and documenting the performance of individuals responsible for high complexity testing at least semiannually during the first year the individual tests patient specimens. 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 competency assessment records and interview with the Laboratory Director (LD) and Office Manager (OM), the Technical Supervisor (laboratory director, CMS 209 personnel # 1) failed to evaluate and document the performance of 4 of 5 testing personnel (TP) responsible for the microscopic examinations for histopathology at least semiannually during their first year from May 2021 to the day of survey. Findings include: 1. On the date of survey, 02/22/2023 at 10:17 am, the Office Manager interviewed confirmed that TP#3, #4 and #5 joined the practice in April 2022. The TP#6 joined the practice in May 2021 and left the practice in March 2022. 2. At the time of survey, the laboratory could not provide semiannual competency assessment documentation for 4 of 5 TP (CMS 209 personnel # 3, #4, #5, #6) who performed microscopic examinations for histopathology during their first year. 3. The laboratory performed 477 and 628 microscopic examinations for histopathology in 2021 and 2022, respectively. 4. The LD and OM confirmed the findings above on 02/22/2023 around 11:15 am. D6128 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(9) The technical supervisor is responsible for evaluating and documenting the performance of individuals responsible for high complexity testing at least annually after the first year, unless test methodology or instrumentation changes, in which case, prior to reporting patient test results, the individual's performance must be reevaluated to include the use of the new test methodology or instrumentation. This STANDARD is not met as evidenced by: Based on review of the laboratory competency assessment records and interview with the Laboratory Director (LD), the Technical Supervisor (laboratory director, CMS 209 personnel # 1) failed to evaluate the competency assessment for 5 of 5 Testing Personnel (TP) who performed microscopic examinations for histopathology from 02 /11/2021 to the day of survey. Findings include: 1. At the time of inspection, the competency assessment documents provided by the laboratory for 5 of 5 TP (CMS 209 personnel #2, #3, #4, #5, #6) who performed microscopic examinations for histopathology from 02/11/2021 to the day of survey were signed by the individual TP (who were not listed as Technical Supervisor on the CMS 209 form) as "Evaluator". 2. The competency assessment documents provided did not show that the competency assessment was performed by the Technical Supervisor. 3. The laboratory performed 477 and 628 microscopic examinations for histopathology in 2021 and 2022, respectively. 4. The LD confirmed the findings above on 02/22/2023 around 11:15 am. -- 2 of 2 --