Baycare Medical Group, Inc

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at Baycare Medical Group Inc. on 09/16/2025. The laboratory was surveyed under 42 CFR Part 493 CLIA requirements. Standard deficiencies cited are as follows: D5435 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(b)(2) (b)(2)(i) Define a function check protocol that ensures equipment, instrument, and test system performance that is necessary for accurate and reliable test results and test result reporting. (b)(2)(ii) Perform and document the function checks, including background or baseline checks, specified in paragraph (b)(2)(i) of this section. Function checks must be within the laboratory's established limits before patient testing is conducted. This STANDARD is not met as evidenced by: Based on record review and interview, the laboratory reported patient test results when an instrument temperature was outside the laboratory's established range for one (08/2025) of three months reviewed (08/2025, 07/2024, 11/2023). Findings included: 1. Daily Quality Assurance/Quality Control Checklist(s) for 08/2025, 07/2024, and 11 /2023 were reviewed. The checklist indicated the required temperature range for the cryostats were -21 degrees to -30 degrees Celsius. The temperature was documented out of range 15 days of 15 days for 08/2025 for cyrostat #2. The temperatures were documented as follows: (A) -32 on the 8th, 11th, 12th, and 13th, (B) -35 on the 15th and 18th, and (C) -34 on the 19th through the 22nd and the 25th through the 29th. 2. Interview with Testing Person A on 09/16/2025 at 12:30 p.m. confirmed the temperatures were out of range and patient testing was reported. D6093 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(5) 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 -- (e)(5) Ensure that the quality control and 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 record review and staff interview, the Laboratory Director failed to establish a quality assessment program (QAP) to monitor all phases or components of the laboratory. Findings included: 1. The laboratory policies and procedures were reviewed. No policy could be found that reflected a QAP was established to review or monitor ongoing compliance for all aspects of laboratory testing; General Laboratory, Preanalytic, Analytic, Postanalytic, and Personnel. 2. Interview with the Laboratory Director on 09/16/2025 at 12:30 p.m. confirmed the above. -- 2 of 2 --

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at Baycare Medical Group Inc on 07/20/21. The laboratory is not in compliance with 42 CFR Part 493, Requirements for Laboratories. The following is a description of the standard level 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 record review and interview with the Laboratory Director, the laboratory failed to record the room temperature every day that testing was performed from April 4, 2019 to the day of survey, July 20, 2021. Findings Included: Record review of the "Daily Quality Assurance/Quality Control Checklist" (QA/QC logs) revealed that the acceptable room temperature was 20-25 degrees Celsius. Review of the Daily Quality Assurance/Quality Control Checklist showed the laboratory was not documenting the room temperature from April 4, 2019 to July 20, 2021. Interview on 07/20/21 at 02:05 PM, the Laboratory Director confirmed that the laboratory had overlooked following their

Summary Statement of Deficiencies D0000 An announced recertification survey was conducted at Baycare Medical Group, Inc on 04/03/19. The facility is not in compliance with 42 CFR Part 493, Requirements for Laboratories. The following is a description of the standard level 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 record review and interview with the Laboratory Personnel, the laboratory failed to record the room temperature and room humidity every day that testing was performed from September 2018 to the day of survey, 04/03/19. Findings Included: Review of the cryostat instrument manual revealed that the operating temperature range should be 18 degrees Celsius to 35 degrees Celsius and the maximum humidity should be 60%. Review of the Daily Quality Assurance/Quality Control Checklist showed the laboratory was not documenting the room temperature from September 8, 2018 to April 3, 2019. In addition, the laboratory was not documenting the humidity from December 3, 2018 to April 3, 2019. The laboratory was documenting if the temperatures and humidity were within range during this time period as "yes," but no temperature or humidity value was recorded. Interview on 04/03/19 at 3:10 PM with the Laboratory Personnel confirmed that the laboratory switched from documenting temperatures and humidity percentages to documenting if the temperatures and humidity were within range. 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 -- D5805 TEST REPORT CFR(s): 493.1291(c) The test report must indicate the following: (c)(1) For positive patient identification, either the patient's name and identification number, or a unique patient identifier and identification number. (c)(2) The name and address of the laboratory location where the test was performed. (c)(3) The test report date. (c)(4) The test performed. (c)(5) Specimen source, when appropriate. (c)(6) The test result and, if applicable, the units of measurement or interpretation, or both. (c)(7) Any information regarding the condition and disposition of specimens that do not meet the laboratory's criteria for acceptability. This STANDARD is not met as evidenced by: Based on record review and interview with the Office Manager, the laboratory failed to include the address of where Histopathology testing was performed since 12/2017. Findings Included: A review of 4 patient final reports from 12/27/2017, 6/2018, 12 /2018 and 3/2019 revealed that 3 of the reports (12/27/2017, 6/2018, and 3/2019) did not contain the address of where the testing was performed. Interview on 04/03/2019 at 3:15 PM with the Office Manager confirmed the 3 patient reports did not contain the address of where testing was performed. -- 2 of 2 --