Memorial Health Partners Foundation, Inc

Summary Statement of Deficiencies D5407 PROCEDURE MANUAL CFR(s): 493.1251(d) (d) Procedures and changes in procedures must be approved, signed, and dated by the current laboratory director before use. This STANDARD is not met as evidenced by: Based on observation of the laboratory, a review of patient test reports, review of laboratory procedure, and staff interview, the laboratory failed to ensure the procedure for the Complete Blood Count: Whole Blood on the Sysmex XN-450/XN-430 Automated Hematology Analyzer was approved by the laboratory director before patient testing began on 08/16/2024. The findings include: 1. Observation of the laboratory on 06/23/2025 at 9:30 a.m. revealed the Sysmex XN 430 Automated Hematology Analyzer (Serial Number 11097) used for patient testing. This instrument was new since the last survey date. 2. A review of patient test reports revealed that the first Complete Blood Count (CBC) from the Sysmex XN 430 was performed on 08/16 /2024 for patient sample number 533010. 3. A review of the laboratory procedure for the Sysmex XN 430 revealed that the laboratory director approved the procedure on 09 /26/2024. 4. The laboratory technical consultant and compliance coordinator confirmed during an interview on 06/23/2025 at 2:15 p.m., the laboratory director did not approve the procedure for the Sysmex XN 430 CBC instrument before patient testing, which began on 08/16/2024. . 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 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 -- 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 a review of the laboratory policy and procedure manual and a staff interview, the laboratory failed to define criteria for essential laboratory conditions when it did not have an approved policy or procedure for temperature and humidity monitoring available on the day of the survey, 06/23/2025. The findings include: 1. A review of the laboratory's policy and procedure manuals revealed no policy defining the laboratory's temperature and humidity monitoring criteria. 2. The technical consultant and compliance coordinator confirmed the survey findings in an interview on 06/23/2025 at 2:15 p.m. . D6013 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(3)(ii) (e)(3)(ii) Verification procedures used are adequate to determine the accuracy, precision, and other pertinent performance characteristics of the method; and This STANDARD is not met as evidenced by: Based on observation of the laboratory, lack of documentation, and staff interviews, the laboratory director failed to ensure that the Sysmex XN 430 Automated Hematology Analyzer, which has been used for Complete Blood Count (CBC) patient testing since 08/16/2024, had been evaluated before use. The findings include: 1. Observation of the laboratory on 06/23/2025 at 8:45 a.m. revealed a Sysmex XN 430 (Serial Number 11097) used for patient testing. 2. No approved instrument validation records were available for review on the survey day, 06/23/2025. 3. The laboratory technical consultant and compliance coordinator confirmed in an interview on 06/23 /2025 at 2:15 p.m. that no approved performance verification records were available. -- 2 of 2 --

Summary Statement of Deficiencies D6033 TECHNICAL CONSULTANT-MODERATE COMPEXITY CFR(s): 493.1409 The laboratory must have a technical consultant who meets the qualification requirements of 493.1411 of this subpart and provides technical oversight in accordance with 493.1413 of this subpart. This CONDITION is not met as evidenced by: Based on a review of the laboratory director (LD) credentials serving as the technical consultant (TC), lack of experience and training of at least one year in non-waived testing in hematology complete blood counts (CBC) and interviews with LD, the LD is not qualified to be the TC for the laboratory in 2018-19 (Refer to D6035). D6035 TECHNICAL CONSULTANT QUALIFICATIONS CFR(s): 493.1411 (a) The technical consultant must be qualified and must possess a current license issued by the State in which the laboratory is located, if such licensing is required. (b) The technical consultant must-- (b)(1)(i) Be a doctor of medicine or doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located; and (b)(1)(ii) Be certified in anatomic or clinical pathology, or both, by the American Board of Pathology or the American Osteopathic Board of Pathology or possess qualifications that are equivalent to those required for such certification; or (b)(2)(i) Be a doctor of medicine, doctor of osteopathy, or doctor of podiatric medicine licensed to practice medicine, osteopathy, or podiatry in the State in which the laboratory is located; and (b)(2)(ii) Have at least one year of laboratory training or experience, or both in non-waived testing, in the designated specialty or subspecialty areas of service for which the technical consultant is responsible (for example, physicians certified either in hematology or hematology and medical oncology by the American Board of Internal Medicine are qualified to serve as the 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 -- technical consultant in hematology); or (b)(3)(i) Hold an earned doctoral or master's degree in a chemical, physical, biological or clinical laboratory science or medical technology from an accredited institution; and (b)(3)(ii) Have at least one year of laboratory training or experience, or both in non-waived testing, in the designated specialty or subspecialty areas of service for which the technical consultant is responsible; or (b)(4)(i) Have earned a bachelor's degree in a chemical, physical or biological science or medical technology from an accredited institution; and (b)(4)(ii) Have at least 2 years of laboratory training or experience, or both in non-waived testing, in the designated specialty or subspecialty areas of service for which the technical consultant is responsible. Note: The technical consultant requirements for "laboratory training or experience, or both" in each specialty or subspecialty may be acquired concurrently in more than one of the specialties or subspecialties of service, excluding waived tests. For example, an individual who has a bachelor's degree in biology and additionally has documentation of 2 years of work experience performing tests of moderate complexity in all specialties and subspecialties of service, would be qualified as a technical consultant in a laboratory performing moderate complexity testing in all specialties and subspecialties of service. This STANDARD is not met as evidenced by: Based on a review of employee records, lack of laboratory director's (LD) credentials serving as the technical consultant (TC) for the specialty Hematology and an interview with the Clinical Compliance Coordinator-Quality, the laboratory failed to have a qualified TC in 2018-19. Findings include: 1. A review of the employee records revealed a Medical Doctor's license for the current TC for 2018-19. 2. The LD credentials serving as the TC were not able to verify one year experience or training for the Hematology specialty. 3. In an interview, on May 8, 2019, at 10:00am, with the Clinical Compliance Coordinator-Quality confirmed the current TC had no documented past laboratory experience as a LD or TC in the past years. -- 2 of 2 --