Queen's Cancer Center Kuakini

Summary Statement of Deficiencies D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) (a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: The surveyor's review of the laboratory Cell-Dyn Emerald (Abbott) procedure, Streck establishing quality control instructions, and interview with 1 of 3 testing personnel (TP#1) revealed the laboratory failed to provide a written procedure for the quality control of new lots of Cell Dyn 18 Plus hematology tri-levels control material in 2025 and 2026. The findings include: 1. The laboratory Cell-Dyn Emerald procedure states Section 4 Quality Control: "A2. Controls, 1. Cell Dyn 18 Plus tri-levels controls manufactured by Abbott" "B. Setting Up New Control Lot, 2. Establish New Control Means a. Run the new lot of controls to get at least 15-20 points. Ideally over a two week period". 2. Streck Establishing Quality Control Means and Standard Deviations for Hematology Instrumentation instructions states: "CLSI H26-A2 states new lot of control material should be assayed in parallel with the current lot in use before the expiration of the current lot." "2. Verify the new lot by running each level of control three times in its respective file." "3. Run each level twice a day for 3-5 days to calculate new mean values for each measurand." 3. TP#1 interviewed on 7/29/2026 at 10:45 AM stated the laboratory followed the Streck establishing quality control instructions. TP#1 confirmed these instructions were not included in the Cell-Dyn Emerald procedure and were not approved by the laboratory director. 4. TP#1 interviewed on 7/29/2026 at 10:50 AM stated the laboratory accepted tri-level control material ranges established by the manufacturer for 7 of 7 new lots received in 2025 and 2026: Lot 5034 Received 2/25/2025 Lot 5118 Received 4/30/2025 Lot 5202 Received 7/23/2025 Lot 5286 Received 10/15/2025 Lot 6005 Received 1/7/2026 Lot 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 -- 6089 Received 4/1/2026 Lot 6173 Received 6/24/2026 New lot acceptability criteria for Cell Dyn 18 Plus hematology tri-level controls were not provided in the laboratory Cell-Dyn Procedure. 5. The laboratory performed an annual volume of 17,000 hematology tests. D6106 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(14) (e)(14) Ensure that an approved procedure manual is available to all personnel responsible for any aspect of the testing process; and This STANDARD is not met as evidenced by: The surveyor's review of the laboratory Cell-Dyn Emerald procedure, Streck establishing quality control instructions, and interview with 1 of 3 testing personnel (TP#1) revealed the laboratory director failed to ensure that an approved procedure manual was available to all TP for the hematology testing it performed in 2025 and 2026. The findings include: 1. TP#1 interviewed on 7/29/2026 at 10:45 AM stated the laboratory followed Streck Establishing Quality Control Means and Standard Deviations for Hematology Instrumentation instructions for new lots of Cell Dyn 18 Plus tri-levels control material. TP#1 confirmed these instructions were not approved by the laboratory director. 2. TP#1 interviewed on 7/29/2026 at 10:50 AM stated the laboratory accepted manufacturer established Cell Dyn 18 Plus tri-levels control ranges for 7 of 7 new lots received in 2025 and 2026. New lot acceptability criteria were not provided in the laboratory Cell-Dyn Procedure. 3. See D tag D5401. -- 2 of 2 --

Summary Statement of Deficiencies 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: Based on a review of American Association of Bioanalysts (AAB) proficiency testing records and an interview with the testing personnel on 09/03/2024 at 3:00 PM, it was revealed that the laboratory failed to ensure its hematology proficiency testing evaluation and verification activities were documented. The findings include: 1. 2023 Nonchemistry M1 event: The laboratory reported an Erythrocytes-3 part diff result of 4.07 on Specimen 1. The intended response range was 4.12 to 4.64. 2. 2023 Nonchemistry (Blood cell identification) M2 event: The laboratory reported Bacteria for Specimen 10. The intended response was Yeast. 3. 2023 Nonchemistry (Educational Challenge) M2 Event: The laboratory reported Lymphocyte; atypical, Downey, variant for Specimen 6. The intended response was Blast undifferentiated. The testing personnel stated the laboratory selected the wrong result code as it does not report abnormal hematology slide results. 4. 2024 Nonchemistry (Blood cell identification) M1 event: The laboratory reported Metamyelocyte for Specimen 3. The intended response was Myelocyte. The testing personnel stated the laboratory selected the wrong result code was it does not report abnormal hematology slide results. 5. 2024 Nonchemistry (Blood cell identification) M2 event: The laboratory reported Monocyte, any stage for Specimen 10. The intended response was Lymphocyte, reactive. 6. The testing personnel stated the laboratory's AAB Medical Laboratory Evaluation (MLE) Proficiency Testing Service Proficiency Test

Summary Statement of Deficiencies D6107 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(15) The laboratory director must specify, in writing, the responsibilities and duties of each consultant and each supervisor, as well as each person engaged in the performance of the preanalytic, analytic, and postanalytic phases of testing, that identifies which examinations and procedures each individual is authorized to perform, whether supervision is required for specimen processing, test performance or result reporting and whether supervisory or director review is required prior to reporting patient test results. This STANDARD is not met as evidenced by: Based on a review of laboratory procedures and an interview with the General Supervisor and testing personnel on 03/11/2021 at 3:00 p.m., it was determined that the Laboratory Director failed to specify in writing, the responsibilities and duties of each consultant and supervisor, as well as each person engaged in the pre-analytic, analytic, and post analytic phases of hematology testing, that identifies which examinations and procedures each individual is authorized to perform, whether supervision is required for specimen processing test performance or result reporting and whether supervisory or director review is required prior to reporting patient test results. The findings include: 1. The testing personnel stated her responsibilities and duties were described in the Laboratory Manager Job Description to include Administrative Duties, Efficient Workflow Environment, Quality Control, Maintenance and Education. The Laboratory Manager Job Description stated that the testing personnel was responsible to "establish quality standards, supervise QC, inspect staff's work and adjusts laboratory policies and procedures as needed when standards are not met". For high complexity testing, the Laboratory Director may delegate the establishment and maintenance of quality assessment and quality control programs to the Technical Supervisor. The Laboratory Director was designated as the Technical Supervisor on the Laboratory Personnel Report Form CMS 209. 2. 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 -- responsibilities and duties delegated by the Laboratory Director to the General Supervisor were not available for review. -- 2 of 2 --