Northwest Specialty Hospital

Summary Statement of Deficiencies D5431 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(2) (a)(2) Function checks as defined by the manufacturer and with at least the frequency specified by the manufacturer. Function checks must be within the manufacturers established limits before patient testing is conducted. (b) Equipment, instruments, or test systems developed in-house, commercially available and modified by the laboratory, or maintenance and function check protocols are not provided by the manufacturer. The laboratory must do the following: This STANDARD is not met as evidenced by: Based on a lack of documentation, i-STAT user guide and an interview with the technical consultant (TC) on 12/11/2025, the laboratory failed to perform six month function checks as required by the manufacturer in 2024 and 2025. The findings include: 1. A lack of i-STAT maintenance/function check documentation identified that the laboratory failed to perform the thermal probe check every six months on two of two i-STAT analyzers in 2024 and 2025. 2. A review of the i-STAT user guide confirmed that the laboratory is required to "Ensure the thermal probe check is performed every 6 months on each analyzer." 3. An interview with the TC on 12/11 /2025 at 11:37 confirmed that the thermal probe checks had not been performed in 2024 and 2025. 4. The laboratory reports performing 8,000 tests annually on the two i- STAT analyzers. D6063 LABORATORY TESTING PERSONNEL CFR(s): 493.1421 The laboratory must have a sufficient number of individuals who meet the qualification requirements of 493.1423, to perform the functions specified in 493. 1425 for the volume and complexity of tests performed. 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 -- This CONDITION is not met as evidenced by: Based on a review of the Centers for Medicare and Medicaid Services (CMS) 209 personnel form, educational documents and an interview with the human resources (HR) officer on 12/11/2025, the laboratory failed to have five (5) testing personnel qualified with the minimum educational requirements. See D6065 D6065 TESTING PERSONNEL QUALIFICATIONS CFR(s): 493.1423(b)(1)(2)(3)(4)(i) (b) Meet one of the following requirements: (b)(1) Be a doctor of medicine or doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located; or (b)(2) Have earned a doctoral, master's, or bachelor's degree in a chemical, biological, clinical or medical laboratory science, or medical technology, or nursing from an accredited institution; or (b)(3) Meet the requirements in 493.1405(b)(3)(i)(B), (b)(4)(i)(B), (b)(4)(i)(C) or (b)(5)(i)(B); or (b)(4) Have earned an associate degree in a chemical, biological, clinical or medical laboratory science, or medical laboratory technology or nursing from an accredited institution; or (b)(5) Be a high school graduate or equivalent and have successfully completed an official military medical laboratory procedures course of at least a duration of 50 weeks and have held the military enlisted occupational specialty of Medical Laboratory Specialist (Laboratory Technician); or (b)(6)(i) Have earned a high school diploma or equivalent; and This STANDARD is not met as evidenced by: Based on a review of the Centers for Medicare and Medicaid Services (CMS) 209 personnel form, educational documents and an interview with the human resources (HR) officer on 12/11/2025, the laboratory failed to have educational documentation for five (5) of 87 personnel performing moderate complexity testing. The findings include: 1. A review of the laboratory's CMS 209 identified 87 testing personnel (TP) performing moderate complexity testing. 2. A review of educational documents for the TP listed on the CMS 209 identified that the laboratory failed to have documentation of the minimal educational requirement for five (5) of 87 TP performing moderate complexity testing. 3. An interview with the HR officer on 12/11 /2025 at 11:45 am confirmed that there was no documentation of education available for five (5) TP to qualify them as moderate complexity TP. 4. The laboratory reports performing 8,000 moderate complexity tests annually. -- 2 of 2 --

Summary Statement of Deficiencies D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(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: Based on a review of proficiency testing (PT) documentation from the American Association of Bioanalysts (AAB) and an interview with the technical consultant (TC) on 3/22/2024, the laboratory failed to have testing personnel and the laboratory director attest to the integration of PT samples with routine testing of patient samples in 2023 and 2024. The findings include: 1. A review of PT documents from AAB identified that the laboratory failed to have the performing testing personnel and the laboratory director attest that PT samples were tested in the same manor as patient samples for event three in 2023 for the specialty of routine chemistry. 2. A review of PT documents from AAB identified that the laboratory failed to have the performing testing personnel and the laboratory director attest that PT samples were tested in the same manor as patient samples for event one in 2024 for the specialty of routine chemistry. 3. An interview with the TC on 3/22/2024 at 9:35 am confirmed the above findings. 4. The laboratory reports performing 2,600 routine chemistry tests annually. D6031 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(13) 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, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(13) Ensure that an approved procedure manual is available to all 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 -- personnel responsible for any aspect of the testing process; This STANDARD is not met as evidenced by: Based on review of laboratory policies and procedures and an interview with the technical consultant (TC) on 3/22/2024, the Laboratory Director (LD) failed to approve laboratory policies and procedures for laboratory personnel to follow. The findings include: 1. A review of the laboratory's policies and procedures identified that the LD failed to approve policies and procedures that included but are not limited to i-STAT testing performance, i-STAT Analyzer/Point of Care Testing, Test Method Validation, CLIA Competency Testing, Proficiency Testing, Reporting Laboratory Quality and Safety Concerns, Laboratory Leadership: Authority, Responsibility and Delegation of Duties, and CLIA Compliance for laboratory personnel to follow. 2. An interview with the TC on 3/22/2024 at 10:28 am confirmed that the LD failed to approve laboratory policies and procedures. 3. The laboratory reports performing 2,600 tests annually. -- 2 of 2 --