Clinical Labs Of Hawaii-Kau Hospital

Summary Statement of Deficiencies 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: The surveyor's review of laboratory records and an interview with the technical consultant (TC1) on May 30, 2025 at 9:30 AM revealed the laboratory failed to establish written policies and procedures to assess the competency of 5 of 5 testing personnel (TP1, TP2, TP3, TP4, TP6). Testing personnel performed an annual volume of 2 mycology and parasitology tests; 1001 routine chemistry; 324 urine sediment examinations; 23 endocrinology tests; and 12,363 hematology tests in 2024. The findings include: 1. TC1 stated the Lab Consultant was on the "List of Designees, Individuals authorized by the Lab Director to act on his/her behalf" policy for competency assessment activities. This policy did not list competency assessment among the activities authorized to a designee. 2. TC1 stated competency assessments to include the six required procedures were performed by laboratory testing personnel. 3. Competency records revealed testing personnel (TP1) performed July 2024 to June 2025 annual evaluations on 3 of 3 testing personnel (TP3, TP4, T6). 4. Competency records revealed testing personnel (TP2) was employed from January 2023 through June 2023. Initial training was performed by a departing testing personnel whose employment overlapped with TP2. 5. Competency records revealed testing personnel (TP6) performed the July 2023 to June 2024 annual evaluation on TP1. TP6 possesses a State of Hawaii Clinical Laboratory Personnel license exception limited to non- waived patient testing only. D5215 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(b)(2) Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 4 -- The laboratory must verify the accuracy of any analyte, specialty or subspecialty assigned a proficiency testing score that does not reflect laboratory test performance (that is, when the proficiency testing program does not obtain the agreement required for scoring as specified in subpart I of this part, or the laboratory receives a zero score for nonparticipation, or late return or results). This STANDARD is not met as evidenced by: The surveyor's review of laboratory College of American Pathologists (CAP) proficiency testing records and an interview with the technical consultant (TC1) on May 30, 2025 at 10:30 AM revealed the laboratory failed to verify the accuracy of its proficiency test results reported in 2023, 2024, and 2025. The findings include: 1. TC1 stated the laboratory did not evaluate its CAP Blood Cell ID, upgraded educational challenge photograph results for 2023 BCP-C survey, specimens BCP-26 to BCP-30, 2024 BCP-A survey, specimens BCP-06 to BCP-10, 2024 BCP-B survey, specimens BCP-16 to BCP-20, 2024 BCP-C survey, specimens BCP-26 to BCP-30, and 2025 BCP-B survey, specimens BCP-16 to BCP-20. 2. The laboratory received a CAP code [27] Lack of participant or referee consensus for proficiency testing results on 2024 Clinical Microscopy CM-B specimen CMP-14, 2025 Clinical Microscopy CM-A urine sediment ID specimen USP-02, and 2025 Clinical Microscopy CM-A CSF & Body Fluid specimen CMP-09. TC1 stated the laboratory did not evaluate their responses with the CAP Participant Summary report. 3. The laboratory received a zero score for its CAP 2024 AQIS-C Critical Care Blood Gas iSTAT blood gas (PCO2, pH, PO2) performance and for its 2024 PCARM-B Point-of Care Cardiac Markers iSTAT B-Type Natriuretic Pep Troponin I, Quant performance. TC1 stated the laboratory did not verify the accuracy of these analytes after the Participant Summary was received. D5221 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(d) All proficiency testing evaluation and verification activities must be documented. This STANDARD is not met as evidenced by: The surveyor's review of laboratory College of American Pathologists (CAP) proficiency testing records and an interview with the technical consultant (TC1) on May 30, 2025 at 10:30 AM revealed the laboratory failed to document its review the unacceptable specimen scores it received in 2023, 2024, and 2025. The findings include: 1. The laboratory received unacceptable specimen scores for 2023 CM-B Urine Sediment ID specimen CMP-15, 2024 BCP-C Blood Cell ID specimen BCP-24, and 2025 BCP-A Blood Cell ID specimen BCP-01. Documentation of laboratory review and

Summary Statement of Deficiencies 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: The surveyor's review of laboratory records, and interview with the laboratory director and general supervisor on 06/16/2023 at 10:00 AM revealed the laboratory failed to follow its written policies and procedures to assess the competency of 3 of 3 testing personnel and 1 general supervisor in 2021 and 2022. The laboratory performs an annual volume of 1231 Chemistry tests, 3989 Hematology tests, 10 General Immunology tests and 2 Mycology tests. The findings include: 1. The laboratory's Competency Testing procedure, SOP-QA-001, Rev 1. 04/08/05 lists the following competency assessment forms for use: "Form 001: Direct Observation Competency form Form 002: Proficiency/Previously Analyzed Sample Competency form Form 003: Worksheet/QC/Maintenance Record Review Competency Form Form 004: Phlebotomy/Processing Direct Observation Form Form 005: Accessioning/Processing Direct Observation Form" 5 of 5 forms for each testing personnel and general supervisor were not available for surveyor review. 2. A review of Form 001: Direct Observation Competency form revealed KOH examinations and Sysmex Hematology Analyzer testing competencies were not included for assessment. D5433 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(b)(1) For 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 establish a 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 -- maintenance protocol that ensures equipment, instrument, and test system performance that is necessary for accurate and reliable test results and test result reporting. The laboratory must perform and document the maintenance activities specified in paragraph (b)(1)(i) of this section. This STANDARD is not met as evidenced by: The surveyor's review of equipment and instrument maintenance records, and interview with the general supervisor on 06/16/2023 at 10:30 AM revealed the laboratory failed to perform annual maintenance on its Zeiss Model STD20 microscope, SN 380078 in 2020, 2021, and 2022. The laboratory performs an annual volume of 400 urine microscopic examinations, 696 manual differentials, and 2 KOH examinations. D6094 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(5) The laboratory director must ensure that the 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: The surveyor's review of equipment and instrument maintenance records, and interview with the general supervisor on 06/16/2023 at 10:30 AM revealed the laboratory director failed to ensure the laboratory established a maintenance protocol for its Zeiss Model STD20 microscope, SN 380078 to ensure the quality of its chemistry, hematology, and mycology testing. See D tag D5433. D6103 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(13) The laboratory director must ensure that policies and procedures are established for monitoring individuals who conduct preanalytical, analytical, and postanalytical phases of testing to assure that they are competent and maintain their competency to process specimens, perform test procedures and report test results promptly and proficiently, and whenever necessary, identify needs for remedial training or continuing education to improve skills. This STANDARD is not met as evidenced by: The surveyor's review of laboratory records and interview with the laboratory director and general supervisor on 06/16/2023 at 10:00 AM revealed the laboratory director failed to ensure policies and procedures are established for monitoring individuals conducting its chemistry, hematology, general immunology, and mycology testing to assure they maintain their competency and whenever necessary, identify needs for remedial training or continuing education to improve skills. See D tag D5209. -- 2 of 2 --

Summary Statement of Deficiencies D5441 CONTROL PROCEDURES CFR(s): 493.1256(a)(b)(c)(g) (a) For each test system, the laboratory is responsible for having control procedures that monitor the accuracy and precision of the complete analytic process. (b) The laboratory must establish the number, type, and frequency of testing control materials using, if applicable, the performance specifications verified or established by the laboratory as specified in 493.1253(b)(3). (c) The control procedures must-- (c)(1) Detect immediate errors that occur due to test system failure, adverse environmental conditions, and operator performance. (c)(2) Monitor over time the accuracy and precision of test performance that may be influenced by changes in test system performance and environmental conditions, and variance in operator performance. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on a review of laboratory quality control records, an interview with testing personnel and confirmation by Technical Consultant 2 on 01/05/2022 at 11:00 am, it was determined that the laboratory failed to monitor the accuracy and precision of its Sysmex hematology testing process by following established control procedures. The findings include: 1. Laboratory quality management procedure, CLHB.QM. 06.3010.0909.2 states "print the L-J (Levey-Jennings) charts for all the levels and parameters in the case of a CBC. Look for evidence of shifts and trends or other QC rule violations". The testing personnel confirmed on 01/05/2022 at 10:45 am that Sysmex control L-J charts were not printed and reviewed for shifts, trends or other QC rule violations. 2. Laboratory quality management procedure, CLHB.QM. 06.3010.0909.2 instructions for "Saving Levey-Jennings Graphs to the CLH Intranet Shared Folder" state "Review Levey-Jennings charts at the end of each lot or monthly". "The tech at the site should go to that saved file and enter relevant comments such as, when calibrations wre performed and reagent lot changes, major maintenance or troubleshooting that was performed if not already indicated. 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 -- Investigate shifts and trends." The testing personnel confirmed on 01/05/2022 at 10:45 am that monthly Sysmex L-J charts were not generated and saved to the intranet shared folder for review. 3. Laboratory quality management procedure, CLHB.QM. 06.3010.0909.2 states in the section, "Supervisor/Lab Manager/Laboratory Director /Designee Review", "Review each Levey-Jennings chart. Enter any relevant comments and indicate your review by adding your name and a date/time stamp". The Technical Consultant 2 confirmed that Sysmex L-J chart review by the Supervisor /Laboratory Director/Designee was not performed. 4. The laboratory performed 5880 hematology tests in 2021. D6020 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(5) 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)(5) Ensure that the quality control program is established and maintained to assure the quality of laboratory services provided. This STANDARD is not met as evidenced by: Based on a review of laboratory quality control records, an interview with testing personnel and confirmation by Technical Consultant 2 on 01/05/2022 at 11:00 am, it was determined that the laboratory director failed to ensure that its established quality control program was maintained to assure the quality of the hematology laboratory services provided. See CFR 493.141256(a)(B)(C)(G), D tag D 5441 -- 2 of 2 --

Summary Statement of Deficiencies D5775 COMPARISON OF TEST RESULTS CFR(s): 493.1281(a)(c) (a) If a laboratory performs the same test using different methodologies or instruments, or performs the same test at multiple testing sites, the laboratory must have a system that twice a year evaluates and defines the relationship between test results using the different methodologies, instruments, or testing sites. (c) The laboratory must document all test result comparison activities. This STANDARD is not met as evidenced by: Based on an interview with the Technical Consultant and Testing Personnel on 8/6 /2019, the lab failed to have a system that twice a year evaluates and defines the relationship between two Abbott iStat analyzers used to perform the same tests. Findings include: a) The technical consultant and testing personnel confirmed that the laboratory maintained two Abbott iStat analyzers for patient testing of Arterial Blood Gases, Prothrombin Time, and Lactate. The technical consultant and testing personnel also confirmed that no system was in place that twice a year evaluates and defines the relationship between the two Abbott iStat analyzers used to perform the arterial blood gas, prothrombin time, and lactate tests. b) The laboratory performs 3 arterial blood gas tests, 38 lactate tests, and 168 prothrombin time tests annually. 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 --