Hawaii Dept Of Health

Summary Statement of Deficiencies D0000 Federal Surveyors from the Centers for Medicare& Medicaid Services (CMS) Survey Branch conducted a recertification survey on 8/11/2025 and 8/12/2025. The following standard level deficiencies were cited. The CMS-2567 was revised on 9/18/2025 and the tag D5451 was removed. D5311 SPECIMEN SUBMISSION, HANDLING, AND REFERRAL CFR(s): 493.1242(a) (a) The laboratory must establish and follow written policies and procedures for each of the following, if applicable: (a)(1) Patient preparation. (a)(2) Specimen collection. (a)(3) Specimen labeling, including patient name or unique patient identifier and, when appropriate, specimen source. (a)(4) Specimen storage and preservation. (a)(5) Conditions for specimen transportation. (a)(6) Specimen processing. (a)(7) Specimen acceptability and rejection. (a)(8) Specimen referral. This STANDARD is not met as evidenced by: I. Based on review of the laboratory's policies, manufacturer's instruction for warmmark temperature indicators, laboratory specimen temperature records, and interview with Technical Supervisor #1, the laboratory failed to follow their own procedures and take

Summary Statement of Deficiencies D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) Reagents, solutions, culture media, control materials, calibration materials, and other supplies must not be used when they have exceeded their expiration date, have deteriorated, or are of substandard quality. This STANDARD is not met as evidenced by: Based on direct observation and laboratory testing personnel interview on August 30, 2023, at 1.15 p.m., it was determined that the laboratory failed to ensure that one (1) of one (1) bottle of 0.05N NaOH, all reagents, solutions, culture media, control materials, calibration materials, and other supplies were not available for use when they have exceeded their expiration date. Findings include: a. During a tour of the LRN-C laboratory, 1 of 1 bottle of 'Calibrator solvent' working solution, 0.05N NaOH, labeled with expiration date November 22, 2022, was observed in the -4 C refrigerator, and therefore available for use in patient testing. b. Based on interview of the general supervisor, the working solution is used in the preparation of calibrators for gas chromatography-mass spectrometry (GC-MS) testing of cyanide in whole blood. c. The general supervisor confirmed on August 30, 2023, at 1.15 p.m., that the 0.05N NaOH solution was available for use when it had exceeded its expiration date. 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 --

Summary Statement of Deficiencies D5415 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(c) Reagents, solutions, culture media, control materials, calibration materials, and other supplies, as appropriate, must be labeled to indicate the following: (1) Identity and when significant, titer, strength or concentration. (2) Storage requirements. (3) Preparation and expiration dates. (4) Other pertinent information required for proper use. This STANDARD is not met as evidenced by: Based on mumps PCR test records review and laboratory personnel interviews on January 18, 2022, the laboratory failed to label mumps PCR test reagents with expiration dates. Findings included: a. In the Laboratory Preparedness and Response Branch (LPRB) - Biological Response Section (BRS) of the laboratory, it was the practice of the laboratory to perform patient testing using a mumps PCR test. b. Based on review of a patient mumps PCR test run performed by the laboratory on April 7, 2021, it was discovered that reagents, which included "Mumps Forward," "Mumps Reverse," "Mumps Probe," "HurRNase Forward," "HurRNase Reverse," "HurRNase Probe," "Human RNA Control - Stratagene," "Mumps Positive Control," and "Mumps Negative Control", used to perform the test run were not labeled with expiration dates. c. According to laboratory personnel, the laboratory tests less than 20 patient specimens annually using the laboratory's mumps PCR test. 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 --

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 laboratory personnel interviews and Chemical Response Section (CRS) test method verification record review on December 10, 2019, the laboratory failed to document all test method verification activities. Findings included: a. In the laboratory's CRS, the laboratory was prepared to perform patient tests related to chemical terrorism using instruments manufactured by Agilent Technologies. At least twice annually, the laboratory's CRS verified the accuracy of the patient tests offered by participating in the Centers for Disease Control and Prevention (CDC) required proficiency testing. b. For 2019, although CRS participated satisfactorily in CDC's required proficiency testing, the laboratory maintained no documentation that proficiency testing result reports were appropriately reviewed by laboratory personnel. c. Documentation of such reviews were required by the laboratory's protocol. 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 reporting. The laboratory must perform and document the maintenance activities specified in paragraph (b)(1)(i) of this section. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- This STANDARD is not met as evidenced by: Based on laboratory personnel interviews and Chemical Response Section (CRS) instrument maintenance record review on December 10, 2019, the laboratory failed to establish a written maintenance protocol that ensures instrument performance that is necessary for accurate and reliable test results and test result reporting. Findings included: a. In the laboratory's CRS, the laboratory was prepared to perform patient tests related to chemical terrorism using instruments manufactured by Agilent Technologies. b. Although the laboratory documented maintenance performed on the Agilent Technologies instruments, the laboratory maintained no written protocols detailing any laboratory required maintenance procedures and the frequency such maintenance must be performed. D5481 CONTROL PROCEDURES CFR(s): 493.1256(f)(g) (f) Results of control materials must meet the laboratory's and, as applicable, the manufacturer's test system criteria for acceptability before reporting patient test results. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on laboratory personnel interviews and bacteriology media quality control record review on December 11, 2019, the laboratory failed to document all bacteriology media quality control procedures performed. Findings included: a. In the microbiology section, the laboratory was performed and reported approximately 29,000 patient test results annually. b. For 1 (accession number 19K012) of 1 randomly selected patient bacteriology specimen received by the laboratory on October 7, 2019, the laboratory maintained no documentation of the following: 1. The lot numbers of the ATCC organisms used by the laboratory to check each batch of media used to culture this patient's specimen for the media's ability to support growth and, as appropriate, select or inhibit specific organism or produce a biochemical response; and, 2. The lot numbers of the commercially and/or in-house manufactured media used to culture this patient's specimen. c. For 1 (accession number 1900013102) of 1 randomly selected patient Neisseria gonorrhoeae (GC) specimen received by the laboratory on October 28, 2019, the laboratory maintained no documentation of the following: 1. The lot numbers of the ATCC organisms used by the laboratory to check each batch of media used to culture this patient's specimen for the media's ability to support growth; and, 2. The lot numbers of the commercially manufactured media used to culture this patient's specimen. d. According to laboratory personnel, it was not the practice of the laboratory to document the lot numbers of the ATCC organisms used to check each batch of media, and it was not the practice of the laboratory to document the lot numbers of the commercially and/or in-house manufactured media used to culture each patient specimen. D5791 ANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1289(a)(c) (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 analytic systems specified in 493.1251 through 493.1283. (c) The laboratory must document all analytic systems assessment activities. -- 2 of 3 -- This STANDARD is not met as evidenced by: Based on laboratory personnel interviews and bacteriology quality assessment record review on December 11, 2019, the laboratory failed to follow written policies and procedures for an ongoing mechanism to monitor and assess bacteriology analytic systems. Findings included: a. In the microbiology section, the laboratory was performed and reported approximately 29,000 patient test results annually. b. For CO2 incubator VWR51014995, laboratory records indicated that quality assessment reviews of the temperature charts was required by the laboratory bimonthly basis. c. The laboratory maintained no documentation of the bimonthly required CO2 incubator VWR510149951 quality assessment temperature chart reviews for the March/April 2019, July/August 2019, and September/October 2019 charts. D6177 TESTING PERSONNEL RESPONSIBILITIES CFR(s): 493.1495(b)(3) Each individual performing high complexity testing must adhere to the laboratory's quality control policies, document all quality control activities, instrument and procedural calibrations and maintenance performed. This STANDARD is not met as evidenced by: Based on laboratory personnel interviews and bacteriology media quality control record review on December 11, 2019, individuals performing high complexity bacteriology testing failed to adhere to the laboratory's media quality control polices. Findings included: a. In the microbiology section, the laboratory was performed and reported approximately 29,000 patient test results annually. b. For 1 (accession number 19K012) of 1 randomly selected patient bacteriology specimen received by the laboratory on October 7, 2019, the laboratory's media quality control documentation indicated: 1. For the lot (#844989, expiration date November 6, 2019) MacConkey agar plate used to culture this patient's specimen, laboratory documentation indicated that Salmonella typhimurium ATCC 14096 was used to check the media's ability to support growth. However, the laboratory's written protocol required the use of Salmonella typhimurium ATCC 14028. 2. For the lot (#844989, expiration date November 6, 2019) MacConkey agar plate used to culture this patient's specimen, laboratory documentation indicated that Shigella flexneri ATCC 12022 was used to check the media's ability to support growth. However, the laboratory's written protocol required the use of Shigella flexneri ATCC 14022. 3. For the lot (#7082926, expiration date February 28, 2022) Lysine Iron agar plate used to culture this patient's specimen, laboratory documentation indicated that Salmonella typhimurium ATCC 14096 was used to check the media's ability to support growth. However, the laboratory's written protocol required the use of Salmonella typhimurium ATCC 14028. 4. For the lot (#7082926, expiration date February 28, 2022) Lysine Iron agar plate used to culture this patient's specimen, laboratory documentation indicated that Shigella flexneri ATCC 12022 was used to check the media's ability to support growth. However, the laboratory's written protocol required the use of Shigella flexneri ATCC 14022. -- 3 of 3 --