Diagnostic Laboratory Services Inc - Hilo

Summary Statement of Deficiencies D5291 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and, when indicated, correct problems identified in the general laboratory systems requirements specified at 493.1231 through 493.1236. This STANDARD is not met as evidenced by: The surveyor's review of laboratory quality management procedures, the lack of documentation, and interview with the general supervisor (GS#3) revealed the laboratory failed to follow to monitor and assess 5 of 5 of its quality performance indicators during 2025 and 2026. The findings include: 1. The laboratory Satellite Quality Plan Section 4. Quality Monitors, Performance Indicators and Quality Assurance procedure states "4.1 Quality indicators are monitored by the laboratory which may include measures for pre-analytical, analytical, and post-analytical processes that affect quality service and patient safety". The laboratory Satellite Performance Indicator Operational Definitions lists five quality performance indicators: Patient Survey, Client Survey, Hand Hygiene, Test in Question (TIQ)- Accessioning Accuracy, and TIQ-Phlebotomy Accuracy. The procedure states the "frequency of data collection and reporting" is monthly except for Client Survey which is collected and reported twice a year. 2. No documentation was presented for review to indicate the laboratory monitored these performance indicators to ensure established targets and reporting requirements were met. GS#3 interviewed on 8/7 /2026 at 11:00 AM confirmed monthly performance indicator data collected by the laboratory was not available for surveyor review. 3. The laboratory performed an annual volume of 4,796 urine sediment examinations and 126,632 hematology tests. D6093 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(5) 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 -- (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: The surveyor's review of 2 of 2 laboratory quality management procedures, the lack of documentation, and interview with the general supervisor (GS#3) revealed the laboratory director failed to ensure the laboratory's quality assessment program was maintained to ensure the quality of its urine sediment examinations and hematology testing during 2025 and 2026. The findings include: 1. No documentation was presented for review to indicate the laboratory monitored 5 of 5 of its Satellite Quality Plan quality performance indicators. 2. GS#3 interviewed on 8/7/2026 at 11:00 AM confirmed the laboratory did not review and monitor its quality performance indicator data to ensure established targets and reporting requirements were met. 3. See Dtag D5291. -- 2 of 2 --

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: Based on a review of laboratory personnel records and an interview with testing personnel on 06/29/2022 at 1:00 PM, it was determined that the laboratory failed to follow written policies and procedures to assess employee competency to ensure personnel maintain the required competency for accurate and reliable testing and reporting. The findings include: 1. Testing personnel were unable to retrieve the 2021 annual competency assessment for the individual who served as the laboratory technical supervisor/general supervisor/testing personnel. 2. The field Operations Manager confirmed on 07/05/2022 at 7:44 AM that a 2021 annual competency assessment for the laboratory technical supervisor/general supervisor/testing personnel was not performed. The areas of competency assessment include: a. Abnormal/unusual findings b. Amending of results, manual and automated c. PT urine cell identification d. Manual differential e. CAP interpretations f. QA Proficiency testing g. QA review h. Siemens Clinitek Adventus/Status i. Sysmex XS1000i j. Stago Satellite (Protime) k. Urinanalysis Manual/macro/micro l. STAT documentation /reporting 3. The laboratory performed 4,732 routine chemistry and urinanalysis tests, and 94,412 hematology tests in 2021. 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 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 -- 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: Based on a review of laboratory personnel records and an interview with the testing personnel on 06/29/2022 at 1:00 PM, and confirmation by the Field Operations Manager on 07/05/2022 at 7:44 AM, it was determined that the laboratory director failed to ensure the policies and procedures established for monitoring individuals who conduct preanalytical, analytical, and post analytical phases of testing were followed to ensure employee competency for accurate and reliable testing and reporting. See CFR 493.1235, D tag D5209. -- 2 of 2 --