Greater Hazleton Gastroenterology

Summary Statement of Deficiencies D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(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: (1) Water quality. (2) Temperature. (3) Humidity. (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 OmanO Biological Microscope used to perform histopathology slide examinations from 03/21 /2023 to the date of survey. Findings include: 1. The operating environment listed in the instruction manual for the OmanO biological microscope states: "microscope should be kept at temperatures between 0C-40C/32F-104F, with a maximum humidity of 85%." 2. On the date of the survey, 12/12/2024 at 12:40 pm, the laboratory failed to provide documentation for monitoring room temperatures and humidity to ensure operating conditions were met for the 1 of 1 OmanO biological microscope (s/n 0814858) used to perform histopathology slide examinations from 03/21/2023 to 12/12 /2024. 3. The laboratory performed 4933 histopathology slide examinations from 03 /21/2023 to 12/12/2024. 4. The LD confirmed the findings above on 12/12/2024 at 12: 45 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 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 competency assessment records and interview with the laboratory director (LD), the laboratory failed to establish written policies and procedures to assess the competency of 2 of 3 clinical consultants (CC) and 2 of 2 general supervisors (GS) for their supervisory responsibilities from 07/01/2021 to the date of the survey. Findings Include: 1. On the day of the survey, 03/21/2023 at 01:14 pm, the laboratory could not provide a written procedure to assess the competency of 2 of 3 CC (CMS 209 personnel # 2, and #3) and 2 of 2 GS (CMS 209 personnel # 2, and #3) for their supervisory responsibilities from 07/01/2021 to 03/21/2023. 2. The laboratory could not provide competency assessment records for 2 of 3 CC and 2 of 2 GS for their supervisory responsibilities in 2021 and 2022. 3. The LD confirmed the findings above on 03/21/2023 around 02:30 pm. 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 and interview with the laboratory director (LD), the laboratory failed to ensure that the verification of accuracy for microscopic 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 -- examinations for histopathology were performed at least twice annually in 2022. Findings Include: 1. On the day of the survey, 03/21/2023 at 01:45 pm, the laboratory could not provide documentation that the verification of accuracy for histopathology slide examinations stained using immunohistochemicals, special stains, and hematoxylin and eosin (H&E) were performed at least twice annually in 2022. 2. The laboratory performed 1977 histopathology examinations in 2022 (CMS 116 annual volume). 3. The LD confirmed the finding above on 03/21/2023 around 02:30 pm. 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. This STANDARD is not met as evidenced by: Based on review of the laboratory's competency assessment records and interview with the laboratory director (LD), the technical supervisor (TS) failed to evaluate the semiannual competency assessment during the first year for 2 of 3 TP who performed histopathology slide examinations from 07/01/2021 to the day of the survey. Findings include: 1. On the day of survey, 03/21/2023 at 01:40 pm, the laboratory could not provide semiannual competency assessment records for 2 of 3 TP (CMS 209 personnel #2, and #3) who performed histopathology slide examinations from 07/01 /2021 to 03/21/2023. 2. The LD confirmed the findings above on 03/21/2023 around 02:30 pm. -- 2 of 2 --