City & County Of Honolulu

Summary Statement of Deficiencies D5433 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(b)(1) (b)(1)(i) Establish a maintenance protocol that ensures equipment, instrument, and test system performance that is necessary for accurate and reliable test results and test result reporting. (b)(1)(ii) 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 laboratory records and interview with testing personnel 2 on 12/12/2025 at 10:00 AM revealed the laboratory failed to perform annual maintenance on its Nikon Eclipse E100LED MV microscope serial number (SN) 731923 in 2024. The findings include: 1. The laboratory performs urine sediment examinations on specimens with "positive blood, protein, leukocytes and/or nitrite dipstick results". 2. Comments/Notes on the Monthly Microscope Maintenance log Annual Maintenance section stated "Not done. Technical Services not able to come to perform the maintenance. They will come in 2025." 3. Testing personnel 2 stated the laboratory director was not notified the annual maintenance was not performed. 4. The laboratory performed 1124 urine sediment examinations in 2024. D6023 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(6) (e)(6) Ensure the establishment and maintenance of acceptable levels of analytical performance for each test system; This STANDARD is not met as evidenced by: The surveyor's review of laboratory records and an interview with testing personnel 2 on 12/12/2025 at 10:00 AM revealed the laboratory director failed to ensure 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 -- maintenance of acceptable levels of analytical performance on its Nikon Eclipse E100LED MV microscope SN 731923 in 2024. See D tag D5433. -- 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 records and an interview with the technical consultant on 12/4/2023 at 9:30 AM. it was revealed that the laboratory failed to follow written policies and procedures to assess its testing personnel and technical consultant competency. The laboratory performed an annual volume of 1085 urine sediment examinations and 4195 urine specific gravity tests. The findings include: 1. Testing personnel #2 was hired in October 2022. Documention of this individual's initial training and six month competency was not available for review. The 2023 annual competency assessment for urine sediment examinations and urine specific gravity tests did not follow CLIA's six procedures. 2. A competency assessment for the technical consultant based on CLIA responsibilities for this position was not performed in 2022 and 2023. This individual also performs testing on patient samples. The 2022 and 2023 annual competency assessment for urine sediment examinations and urine specific gravity tests did not follow CLIA's six procedures. 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 maintenance protocol that ensures equipment, instrument, and test system performance that is necessary for accurate and reliable test results and test result 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 -- 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: Based on a review of laboratory maintenance records and an interview with the technical consultant on 12/4/2023 at 10:00 AM. it was revealed that the laboratory failed to perform annual preventive maintenance on its Nikon Eclipse E100LED MV microscope SN 731923 in 2021 and 2022. The laboratory performed an annual volume of 1085 urine sediment examinations. D6021 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 quality assessment programs are 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 records and an interview with the technical consultant on 12/4/2023 at 9:30 AM. it was revealed that the laboratory director failed to ensure its quality assessment program is maintained to assure the quality of laboratory services provided and to identify failures in quality as they occur. The findings include: 1. The laboratory failed to perform annual preventive maintenance on its Nikon Eclipse E100LED MV microscope SN 731923 in 2021 and 2022. Refer to D tag D5433. D6030 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(12) 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)(12) 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: Based on a review of laboratory records and an interview with the technical consultant on 12/4/2023 at 9:30 AM. it was revealed that the laboratory director failed to ensure its competency assessment program was maintained to assure the quality of laboratory services provided by its testing personnel. Refer to D tag D5209. -- 2 of 2 --

Summary Statement of Deficiencies D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document maintenance as defined by the manufacturer and with at least the frequency specified by the manufacturer. This STANDARD is not met as evidenced by: Based on a review of laboratory records and confirmation by the testing personnel on 02/25/2022 at 3:00 PM, it was determined that the laboratory failed to perform and document maintenance on its urine specific gravity refractometer as defined by the manufacturer and with at least the frequency specified by the manufacturer. The findings include: 1. ATAGO Quick Guide for urine specific gravity Pocket Pal-10S states the surface of the refractometer should be cleaned prior to Zero Set and UQC, and prior to and after each patient test. 2. ATAGO Quick Guide for urine specific gravity Pocket Pal-10S states the following "Instrument Cleaning & Precautions": a. Clean with Distilled Water (0.5 or 1L open expiry one month) b. Disinfect with 2% Chlorhexidine & 70% isopropyl alcohol prep pad or Caviwipes (Metrex). Use 2nd wipe to disinfect surface. Wipe dry. 3. Testing personnel stated that instrument cleaning and precautions were not performed on its ATAGO Pocket Pal-10S refractometer, SN B928931 in use since 10/17/2014. 4. The laboratory performed 6000 urine specific gravity tests in 2021. D5431 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(2) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document function checks as defined by the manufacturer and with at least the frequency specified by the manufacturer. Function checks must be within the manufacturer's established limits before patient testing is conducted. 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 STANDARD is not met as evidenced by: Based on a review of laboratory records and confirmation by the testing personnel on 02/25/2022 at 3:00 PM, it was determined that the laboratory failed to perform and document function checks on its urine specific gravity refractometer as defined by the manufacturer and with at least the frequency specified by the manufacturer before patient testing is conducted. The findings include: 1. ATAGO Quick Guide for urine specific gravity Pocket Pal-10S states Zero Set must be "performed prior to quality control and patient testing". Use FORM A to record this activity. 2. ATAGO Quick Guide for urine specific gravity Pocket Pal-10S states "UQC is performed daily with patient use, weekly when not in use". Ensure "both QC levels are within documented range before proceeding with patient testing. Record all values on FORM A". 3. Testing personnel stated that instrument function checks were not performed on its ATAGO Pocket Pal-10S SN B928931 in use since 10/17/2014. Testing personnel also stated that a FORM A was not available for use in the laboratory. 4. The laboratory performed 6000 urine specific gravity tests in 2021. D6023 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(6) 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)(6) Ensure the establishment and maintenance of acceptable levels of analytical performance for each test system; This STANDARD is not met as evidenced by: Based on a review of laboratory records and confirmation by the testing personnel on 02/25/2022 at 3:30 PM, it was determined that the laboratory director failed to ensure the establishment and maintenance of acceptable levels of analytical performance for its ATAGO Pocket Pal-10S urine specific gravity refractometer test system. The findings include: 1. The laboratory failed to perform and document maintenance on its urine specific gravity refractometer as defined by the manufacturer and with at least the frequency specified by the manufacturer. See CFR 493.1254(a)(1), D tag D5429. 2. The laboratory failed to perform and document function checks on its urine specific gravity refractometer as defined by the manufacturer and with at least the frequency specified by the manufacturer before patient testing is conducted. See CFR 493.1254 (a)(2), D tag D5431. -- 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 review of the laboratory's personnel evaluation procedure and interview with the laboratory director and 2 technical consultants on 1/17/18, the laboratory failed to follow their written policies and procedures to assess employee competency in 2016 and 2017. Findings included: a. The laboratory's procedure to assess employee competency anually was followed for one testing personnel, DN, in 2015. There was no documentation that 2 testing personnel, DN and KP, were assessed in 2016 ad 2017. b. The 2 testing personnel performed and reported 911 patient test results on urine microscopic examinations each year. 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: Based on review of the laboratory's personnel competency assessment procedures and interview of the laboratory director and technical consultants on 1/17/18, the laboratory failed to establish and follow written policies and procedures for an 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 -- ongoing mechanism to monitor, assess, and, when indicated, correct problems identified in the general laboratory systems requirements specified at 493.1231 through 493.1236. Findings included: The laboratory had not established written policies and procedures to monitor and correct their failure to follow their personnel competency assessment procedures. (See D5209) -- 2 of 2 --