Dean Mcgee Pathology - Mcgee Eye Surgery Center

Summary Statement of Deficiencies D0000 The recertification survey was performed on 04/16/2025. The laboratory was found in compliance with a standard-level deficiency cited. The findings were reviewed with the laboratory director and general supervisor at the conclusion of the survey. 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 a review of records, written policies and procedures, and interview with the laboratory director and general supervisor, the laboratory failed to have a written policy to assess the competency of clinical consultant #2 and general supervisor, based on the position responsibilities as listed in Subpart M, for one of one person. Findings include: (1) A review of the laboratory policy and procedure manual identified no evidence of a policy for assessing the competency of the clinical consultant and general supervisor, including the frequency of the assessments; (2) A review of the Form CMS-209 (Laboratory Personnel Report) and personnel records for competency assessments performed during the review period of January 2024 through the current date identified competencies, based on job responsibilities, had not been performed for one of one person listed as clinical consultant #2 and general supervisor; (3) The findings were reviewed with the laboratory director and general supervisor. Both stated on 04/16/2025 at 10:30 am, a policy had not been written and competencies had not been performed for the positions as stated above. 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 D0000 The initial survey was performed on 03/30/2021. The laboratory was found in compliance with standard-level deficiencies cited. The findings were reviewed with the laboratory director at the conclusion of the survey. 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 a review of records, observation, and interview with the laboratory director and general supervisor, failed to ensure the cryostat was maintained at an acceptable temperature 1 of 5 days; and failed to ensure materials were stored as required. CRYOSTAT TEMPERATURE (1) On 03/30/2021 at 10:00 am, the general supervisor stated to the surveyor the laboratory performed frozen sections on ophthalmic specimens using the Tissue Tech II Cryostat; (2) The surveyor reviewed cryostat temperature records for testing performed from 04/03/2020 through 03/26 /2021. The defined acceptable temperature range, as stated on the temperature log, was -15 to -25 degrees C (Centigrade). The review showed the cryostat temperature had not been documented 1 of 5 days of patient testing. The specific day was 03/26 /2021; (3) The surveyor reviewed the records with the general supervisor, who stated to the surveyor on 03/30/2021 at 10:30 am, the cryostat temperature had not been documented on 03/26/2021. ROOM TEMPERATURE (1) On 03/30/2021 at 11:10 am, the surveyor observed the frozen section room and identified the following, 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 -- including the manufacturer's storage requirement: (a) Rapid Chrome H&E Frozen Section Staining Kit, lot #496135, with a storage requirement of 15-30 degrees C; (b) Sakura Tissue-Tek Optimal Cutting Temperature Compound, lot 9975-00, with a storage requirement of 15-30 degrees C. (2) The surveyor asked the general supervisor if the laboratory had monitored the room temperature of the frozen section room during the review period of April 2020 through the current time. The general supervisor stated to the surveyor on 03/30/2021 at 11:15 am, the room temperature had not been monitored. 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: -- 2 of 2 --