Lifebrite Community Hospital Of Early

Summary Statement of Deficiencies D0000 A Clinical Laboratory Improvement Amendments (CLIA) Recertification Survey was completed on March 3, 2026. The laboratory was not in compliance with applicable CLIA requirements found at 42 CFR 493.1 through 42 CFR 493.1780. The following deficiencies were cited: D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) (b)(1) The individual testing or examining the samples and the laboratory director must attest to the routine integration of the samples into the patient workload using the laboratory's routine methods. This STANDARD is not met as evidenced by: A review of the 2024 - 2026 API Proficiency Testing Records confirmed that the laboratory failed to attest to the routine integration of the samples into the patient workload using the laboratory's routine methods. THE FINDINGS INCLUDE: 1. A review of the 2024 - 2026 API Proficiency Testing Records revealed seven (7) of eight (8) Proficiency Testing Attestation statements were unsigned by the Laboratory Director. 2. An exit interview, with Lab Staff, on March 3, 2026, at 3:00pm confirmed that the Laboratory Director failed to attest to the routine integration of the samples into the patient workload using the laboratory's routine methods. 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 applicable, include the following: (b)(1) Water quality. (b)(2) Temperature. (b)(3) Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 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: A tour of the laboratory confirmed that the laboratory failed to store reagents/ specimens as required by the manufacturer. THE FINDINGS INCLUDE: 1. A tour of the facility confirmed that in-use and/ or stored reagents and supplies, with temperature storage requirements, were in locations in which the temperature was not monitored. 2. The facility tour revealed the following agents in the Drawing Station : a. Becton Dickinson (BD) EDTA Vacutainer Tubes, BD EDTA Pediatric Vacutainer Vials, BD Sodium Citrate Vacutainer Tubes, BD Serum Separator Vacutainer Tubes, BD Lithium Heparin Vacutainer Tubes, BD SST Vacutainer Tubes, and BD Red Serum Vacutainer Tubes, with a storage temperature requirement of 4C - 25C 3. The facility tour revealed the following agents in the Reagent Storage Room : a. Becton Dickinson (BD) EDTA/ K2EDTA Vacutainer Tubes, BD EDTA Pediatric Vacutainer Vials, BD K2E 5.4mg vacutainer Tubes, BD Sodium Citrate Vacutainer Tubes, BD Serum Separator Vacutainer Tubes, BD Lithium Heparin Vacutainer Tubes, BD Red Serum Vacutainer Tubes, BD SST Vacutainer Tubes, Greiner Bio-One Sodium Fluoride/ Potassium Oxalate Vacutainer Tubes, Becton Dickinson (BD) EDTA/ K2EDTA Microtainer Tubes, BD Lithium Heparin Microtainer Tubes, BD SST Microtainer Tubes, with a storage temperature requirement of 4C - 25C. b. Accu- Chek Inform II Glucose Test Strips, with a storage temperature requirement of 4C - 30C. c. Para-Pak C&S Transport Vial, with a storage temperature requirement of 2C - 30C. d. Para-Pak 10% Buffered Formalin Ova & Parasite Stool Specimen Transport Vials with a storage temperature requirement of15C - 30C 4. An exit interview, with Lab Staff, on March 3, 2026, at 3:00pm confirmed that the laboratory failed to store reagents/ specimens/ etc. as mandated by the manufacturer. D6020 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(5) (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: A review of the API Proficiency Test Records, Maintenance Records, Quality Control Records, Quality Assurance, Personnel Records and Temperature Records for years 2024 - 2026 confirmed that the Laboratory Director failed to ensure that the quality control and quality assessment programs are established and maintained. THE FINDINGS INCLUDE: 1. A review of the aforementioned 2024 - 2026 laboratory records confirmed the lack of Laboratory Director's quality assurance review. 2. A review of the 2024 - 2026 laboratory records revealed that quality assurance review was performed by the General Supervisor without written delegation of such duties by the Laboratory Director. 3. An exit interview, with Lab Staff, on March 3, 2026, at 3: 00pm confirmed that the Laboratory Director failed to ensure that the quality control and quality assessment programs are established and maintained. D6079 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(a)(b) -- 2 of 3 -- The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, record and report test results promptly, accurately and proficiently, and for assuring compliance with the applicable regulations. (a) The laboratory director, if qualified, may perform the duties of the technical supervisor, clinical consultant, general supervisor, and testing personnel, or delegate these responsibilities to personnel meeting the qualifications under 493.1447, 493.1453, 493.1459, and 493.1487 respectively. (b) If the laboratory director reapportions performance of his or her responsibilities, he or she remains responsible for ensuring that all duties are properly performed. This STANDARD is not met as evidenced by: A review of the API Proficiency Test Records, Maintenance Records, Quality Control Records, Quality Assurance, Personnel Records and Temperature Records for the laboratory for the period of Year 2024 - Year 2026 review period confirmed that the Laboratory Director failed to conduct successful oversight of the overall operation and administration of the laboratory. Reference: D2009, D5413, D6020, and D6063 . -- 3 of 3 --

Summary Statement of Deficiencies D0000 A recertification survey was performed on January 25, 2024. The facility was found to be NOT in compliance with the CLIA conditions and standards for specialties /subspecialties for 42 CFR. Condition: 493.1255b -Calibration and Calibration Verification NOTE: The CMS-2567 (Statement of Deficiencies) is an official , legal document,. All information must remain unchanged except for entering the

Summary Statement of Deficiencies D0000 A Clinical Laboratory Improvement Amendments (CLIA) Recertification survey was completed on March 4, 2022. The laboratory was not in compliance with applicable CLIA requirements found at 42 CFR 493.1 through 42 CFR 493.1780. The following deficiencies were cited: D2016 SUCCESSFUL PARTICIPATION CFR(s): 493.803(a)(b)(c) (a) Each laboratory performing nonwaived testing must successfully participate in a proficiency testing program approved by CMS, if applicable, as described in subpart I of this part for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. (b) Except as specified in paragraph (c) of this section, if a laboratory fails to participate successfully in proficiency testing for a given specialty, subspecialty, analyte or test, as defined in this section, or fails to take remedial action when an individual fails gynecologic cytology, CMS imposes sanctions, as specified in subpart R of this part. (c) If a laboratory fails to perform successfully in a CMS- approved proficiency testing program, for the initial unsuccessful performance, CMS may direct the laboratory to undertake training of its personnel or to obtain technical assistance, or both, rather than imposing alternative or principle sanctions except when one or more of the following conditions exists: (1) There is immediate jeopardy to patient health and safety. (2) The laboratory fails to provide CMS or a CMS agent with satisfactory evidence that it has taken steps to correct the problem identified by the unsuccessful proficiency testing performance. (3) The laboratory has a poor compliance history. This CONDITION is not met as evidenced by: Based on review of the American Proficiency Institute (API) Proficiency Testing (PT) documents for 2021, second event for the Speciality Immunohematology, sub- specialty Compatibility Testing, the laboratory obtained a score less than 100% which is an unsatisfactory performance. Reference: D2173 Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- D2173 COMPATIBILITY TESTING CFR(s): 493.863(a) Failure to attain an overall testing event score of at least 100 percent is unsatisfactory performance. This STANDARD is not met as evidenced by: Based on review of the American Proficiency Institute (API) Proficiency Testing (PT) documents for 2021, second event for the Speciality Immunohematology, sub- specialty Compatibility Testing, the laboratory obtained a score less than 100% which is an unsatisfactory performance. Findings: 1. Review of the APT PT documents for the year 2021 second event, the laboratory received a score of 80% for the sub- specialty of Compatibility Testing. 2. Interview with the laboratory Manager, on April 5, 2022, at approximately 2pm in the laboratory confirmed the aformentioned statement. D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) Reagents, solutions, culture media, control materials, calibration materials, and other supplies must not be used when they have exceeded their expiration date, have deteriorated, or are of substandard quality. This STANDARD is not met as evidenced by: Based on review of the Blood Bank (BB) Quality Control (QC), for the year 2020, the laboratory performed the QC with expired reagents and performed BB testing with the same expired reagents. Findings: 1. Review of the BB QC log for the year 2020, the laboratory performed QC using expired Anti-A reagent on April 27, 2020. The reagent expired on April 21, 2020. Compatibility Testing for two units of blood, was performed, using the expired reagent, and the two units were transfused, on April 27, 2020. 2. Interview with the Laboratory Manager on April 5, 2022, at approximately 2 pm in the laboratory confirmed the aforementioned statement. D6076 LABORATORY DIRECTOR CFR(s): 493.1441 The laboratory must have a director who meets the qualification requirements of 493. 1443 of this subpart and provides overall management and direction in accordance with 493.1445 of this subpart. This CONDITION is not met as evidenced by: Based on review of the American Proficiency Institute (API) Proficiency Testing (PT) documents for the year 2021, second event, for the sub-speciality Compatibility Testing, and the Blood Bank (BB) Quality Control (QC) log sheet for April 27, 2020. The Laboratory Director (LD) failed to provide overall management and direction in the laboratory. Findings: 1. Review of the APT PT documents for the year 2021 second event, the laboratory received a score of 80% for the sub-specialty of Compatibility Testing. 2. Review of the BB QC log for the year 2020, the laboratory performed QC using expired Anti-A reagent on April 27, 2020. The reagent expired on April 21 2020. Compatibility Testing for two units of blood, was performed, using -- 2 of 3 -- the expired reagent, and the two units was transfused, on April 27, 2020. 3. Interview with the Laboratory Manager, on April 5, 2022, at approximately 2:15 pm, in the Laboratory confirmed the aforementioned statements. -- 3 of 3 --

Summary Statement of Deficiencies D0000 A Clinical Laboratory Improvement Amendments (CLIA) Recertification survey was completed on October 8-9, 2019. The laboratory was not in compliance with applicable CLIA requirements found at 42 CFR 493.1 through 42 CFR 493.1780. The following deficiencies were cited: D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) The procedure manual must include the following when applicable to the test procedure: (1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (2) Microscopic examination, including the detection of inadequately prepared slides. (3) Step-by-step performance of the procedure, including test calculations and interpretation of results. (4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (5) Calibration and calibration verification procedures. (6) The reportable range for test results for the test system as established or verified in 493.1253. (7) Control procedures. (8)