Mesquite Gastroenterology

Summary Statement of Deficiencies 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 testing personnel competency evaluation documentation and interview with the testing personnel (TP-1), it was determined that the technical supervisor failed to evaluate the performance of one out of one testing personnel at least annually during 2022 and 2023. Findings include: 1. The laboratory performs the gross desription of histopathology specimens under the specialty of Pathology, with a reported annual test volume of 6,806. 2. The CMS-209, Laboratory Personnel Form submitted during the survey conducted on 01/25/2024 indicates the same individual is assigned to the following required personnel positions: Laboratory Director, Clinical Consultant, Technical Supervisor, and General Supervisor. 3. The laboratory presented evidence for review during the survey to indicate the Laboratory Director /Technical Supervisor was not on-site at the laboratory during 2022 and 2023. 4. The annual competency evaluations presented for review from 2022 and 2023 for TP-1 showed that the technical supervisor signed off on the competency evaluations, including but not limited to, the direct observation of grossing specimens. 5. The Technical Supervisor failed to perform the annual competency evaluations for TP-1 during 2022 and 2023 as referenced above. 6. The TP-1 interviewed at 10:25 AM stated that another individual who is not listed on the CMS-209 form as a Technical Supervisor performed the on-site competency evaluations during 2022 and 2023 for TP-1. 7. The duties and responsibilities of the Technical Supervisor may only be delegated to another qualified individual under 493.1449(l). 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 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 lack of room temperature logs for review and interview with the facility personnel, the laboratory failed to document the temperature of the room where slide staining reagents are stored for testing under the sub-specialty of Histopathology . Findings include: 1. No room temperature logs pertaining to the room where staining reagents are stored were presented for review during the survey conducted on January 4, 2019. 2. The facility personnel confirmed that the laboratory was not documenting the room temperature as indicated above. 3. The test volume under the sub-specialty of Histopathology is approximately 4500 per year 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 --