State Of Hawaii Department Of Health Std Clinic

Summary Statement of Deficiencies D0000 The following deficiencies are a result of a desk review of proficiency testing scores obtained from the national database and verified with the proficiency testing company. The facility was found to be out of compliance with the conditions of the CLIA program. The following CONDITION LEVEL DEFICIENCIES were found to be out of compliance: D2016 - 42 C.F.R. 493.803 Condition: Successful participation [proficiency testing] D6076 - 42 C.F.R. 493.1441 Condition: Laboratories performing high complexity testing; laboratory director D2016 SUCCESSFUL PARTICIPATION CFR(s): 493.803(a)(b)(c) (a) Each laboratory performing nonwaived testing must successfully participate in a proficiency testing program approved by CMS, if applicable, as described in subpart I of this part for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. (b) Except as specified in paragraph (c) of this section, if a laboratory fails to participate successfully in proficiency testing for a given specialty, subspecialty, analyte or test, as defined in this section, or fails to take remedial action when an individual fails gynecologic cytology, CMS imposes sanctions, as specified in subpart R of this part. (c) If a laboratory fails to perform successfully in a CMS- approved proficiency testing program, for the initial unsuccessful performance, CMS may direct the laboratory to undertake training of its personnel or to obtain technical assistance, or both, rather than imposing alternative or principle sanctions except when one or more of the following conditions exists: (1) There is immediate jeopardy to patient health and safety. (2) The laboratory fails to provide CMS or a CMS agent with satisfactory evidence that it has taken steps to correct the problem identified by the unsuccessful proficiency testing performance. (3) The laboratory has a poor compliance history. This CONDITION is not met as evidenced by: Based on a proficiency testing desk review of the Certification and Survey Provider 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 -- Enhanced Reporting (CASPER) 0155 report and College of American Pathologists (CAP) 2024 records, the laboratory failed to successfully participate in a proficiency testing program approved by HHS, for each specialty, subspecialty, and analyte in which the laboratory is certified under CLIA. The laboratory failed to successfully participate in the subspecialty of Bacteriology. Refer to D2028 D2028 BACTERIOLOGY CFR(s): 493.823(e) (e) Failure to achieve an overall testing event score of satisfactory performance for two consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on a proficiency testing desk review of the CASPER 0155 report and CAP 2024 proficiency testing records, the laboratory failed to achieve satisfactory performance (80% or greater) for the same analyte in two of three consecutive testing events (2024 Event 1 and Event 3) in the subspecialty of Bacteriology. Findings included: 1. Review of the CASPER 0155 report revealed the following results: CAP D5-A 2024 Gram Stain- 1st Event The laboratory received an unsatisfactory score of 60 % for Bacteriology. CAP D5-C 2024 Gram Stain - 3rd Event The laboratory received an unsatisfactory score of 40 % for Bacteriology. 2. A review of CAP 2024 proficiency testing records confirmed the laboratory failed to successfully participate in the subspecialty of Bacteriology. D6076 LABORATORY DIRECTOR CFR(s): 493.1441 The laboratory must have a director who meets the qualification requirements of 493. 1443 of this subpart and provides overall management and direction in accordance with 493.1445 of this subpart. This CONDITION is not met as evidenced by: Based on a proficiency testing desk review of the CASPER 0155 report and CAP 2024 proficiency testing records, the laboratory director failed to provide overall management and direction of the laboratory services. Refer to D6089. D6089 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(4)(i) (e)(4)(i) The proficiency testing samples are tested as required under subpart H of this part; This STANDARD is not met as evidenced by: Based on a proficiency testing desk review of the CASPER 0155 report and CAP 2024 proficiency testing records, the laboratory director failed to ensure the overall quality of the laboratory services provided. The laboratory director failed to ensure successful participation in an HHS approved proficiency testing program. Refer to D2028. -- 2 of 2 --

Summary Statement of Deficiencies D0000 A recertification on-site survey was conducted on 12/6/2024, the laboratory was surveyed under 42 CFR Part 493 CLIA regulations and was found to have a standard level deficiency cited. 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 interview with Technical Consultant #1, the laboratory failed to ensure cotton swabs found in patient exam room did not exceed their expiration date for KOH and direct wet mount tests as evidenced by: 1. In direct observation on 12-06-2024 at 1045 in the patient exam room, the following reagents were found to be expired: 23-sterile cotton tip application utility lot 5842 expiration date 10-01-2023. 2. In interview with technical consultant #1 12-06-2024 at 1046 he acknowledged that the the cotton tips were expired and confirmed that they were using them for KOH and direct wet mount tests. 3. According to the CMS-116, the laboratory performs 2080 KOH and direct wet mounts tests per year. 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 observation, interview and document review, the laboratory failed to label gram staining reagent in use to indicate expiration date. Findings include: a. During the virtual tour of the laboratory's gram staining area on 12/6/22, the surveyor observed that the working solution bottle of ethyl alcohol labeled, 'Ethyl Alcohol reagent, Denatured, Spectrograde, Contains 5% 2-PrOH and 5% MeOH,' was not labeled with an expiration date. b. Observation showed an amber ethyl alcohol stock solution bottle, labeled 'Ethyl Alcohol reagent, Denatured, Spectrograde, Contains 5% 2-PrOH and 5% MeOH,' from which the working solution was transferred. c. Interview at 1.15 p.m. (PST) on 12/6/22 with testing personnel (TP#1) confirmed that the contents of the ethyl alcohol working solution bottle were transferred from the stock solution, and that the ethyl alcohol working solution bottle was currently in use by the laboratory not labeled with an expiration date. d. Review of procedure, 'QC for Reagents,' revealed "expiration dates inclusive of month, day and year will be written on all working gram stain reagent and daily use reagent bottles, the bottles will be checked monthly for the expiration date documented on the 'Solutions expiration dates log' and the review documented on the log." e. The technical consultant #2 and QA/ Training Coordinator confirmed on 12/6/22 at 4.35 p.m. (PST) that the ethyl alcohol working solution bottle was not labeled with an expiration date. f. The laboratory performs an annual test volume of 1070, of which 800 are gram stains. 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 -- 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. This STANDARD is not met as evidenced by: Based on observation, interview and document review, the laboratory failed to ensure preventive maintenance (PM) service was performed on two of two microscopes. Findings include: 1. Based on observation, maintenance service tags, dated 10/21/21 were affixed to microscopes, Zeiss S/N: 123655 (#1) and Olympus S/N: 9H14616 (#2). 2. Interview at 3.24 p.m. (PST) on 12/6/22 with testing personnel (TP#1) revealed that microscope (#1) is the primary one in use and microscope (#2) is used as a backup. TP#1 confirmed at 3.24 p.m. (PST) that per the date on the affixed service tags both microscopes were past due for preventive maintenance service. 3. Review of procedure, 'Equipment Maintenance,' showed that microscopes will be serviced annually and the most recent service date recorded on the microscope base. 4. Review of maintenance documentation dated on 10/21//21, showed that annual preventive maintenance service had been performed on both microscopes in 2021. The laboratory had no record of completed annual service for 2022 at the time of the survey. 5. The technical consultant (TC#2) and QA/ Training Coordinator confirmed on 12/6/22 at 4.35 p.m. that the laboratory failed to perform and document preventive maintenance of the microscopes as defined by the laboratory's procedure. 6. The laboratory reports an annual test volume of 1070. -- 2 of 2 --

Summary Statement of Deficiencies D5469 CONTROL PROCEDURES CFR(s): 493.1256(d)(10)(g) Unless CMS Approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing, the laboratory must-- Establish or verify the criteria for acceptability of all control materials. (i) When control materials providing quantitative results are used, statistical parameters (for example, mean and standard deviation) for each batch and lot number of control materials must be defined and available. (ii) The laboratory may use the stated value of a commercially assayed control material provided the stated value is for the methodology and instrumentation employed by the laboratory and is verified by the laboratory. (iii) Statistical parameters for unassayed control materials must be established over time by the laboratory through concurrent testing of control materials having previously determined statistical parameters. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on laboratory personnel email communications and Gram stain quality control record review on March 24, 2021, the laboratory failed to establish over time statistical parameters for unassayed Gram stain quality control slides through concurrent testing of quality control materials having previously determined statistical parameters. Findings included: a. It was the practice of the laboratory to perform Gram stain quality control procedures using unassayed Gram positive and negative quality control slides made by another laboratory to monitor its patient testing. b. Upon receipt of the unassayed Gram stain quality control slides, the laboratory did not test the newly received unassayed quality control slides concurrent with previously established quality control slides before using the newly received unassayed quality control slides to independently monitor patient Gram stain testing. c. On March 2, 2020, the laboratory tested and reported one patient Gram stain result in which Gram stain quality procedures were performed. However, the laboratory maintained no 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 -- documentation to indicate that statistical parameters for the unassayed Gram stain quality control slides that were used on March 2, 2020 had been established over time by the laboratory through concurrent testing with quality control slides having previously determined statistical parameters. -- 2 of 2 --

Summary Statement of Deficiencies D2020 BACTERIOLOGY CFR(s): 493.823(a) Failure to attain an overall testing event score of at least 80 percent is unsatisfactory performance. This STANDARD is not met as evidenced by: Based on review of the laboratory's College of American Pathologists (CAP) proficiency records, the CMS Casper record and interview with the laboratory Director and the laboratory Technical Supervisor on July 12, 2018, the laboratory failed to attain an overall testing event score of at least 80 percent resulting in unsatisfactory performance for Bacteriology CAP D5-A event 1 of 2018. Findings include: a. For CAP D5-A 2018 gram Stain identification, and Morphology: the laboratory failed 2 out of 5 slide reviews, achieving an overall event score of 60%. Results: Gram stain: D5-01, Acceptable D5-02, Acceptable D5-03 - Unacceptable D5- 04 - Unacceptable D5-05, Acceptable Morphology: D5-01, Acceptable D5-02- Unacceptable D5-03- Unacceptable D5-04, Acceptable D5-05, Acceptable b. The laboratory Director and Technical supervisor confirmed this deficient score by interview on July 12, 2018 at approximately 10:00 am. c. The laboratory reports performing approximately 3000 Gram stains annually and 750 Morphology reviews annually. D5801 TEST REPORT CFR(s): 493.1291(a) The laboratory must have an adequate manual or electronic system(s) in place to ensure test results and other patient-specific data are accurately and reliably sent from the point of data entry (whether interfaced or entered manually) to final report destination, in a timely manner. This includes the following: (a)(1) Results reported from calculated data. (a)(2) Results and patient-specific data electronically reported to 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 -- network or interfaced systems. (a)(3) Manually transcribed or electronically transmitted results and patient-specific information reported directly or upon receipt from outside referral laboratories, satellite or point-of-care testing locations. This STANDARD is not met as evidenced by: Based on a random review of patient records on July 12, 2018, the laboratory failed to ensure test results and other patient-specific data are accurately and reliably sent from the point of data entry (whether interfaced or entered manually) to final report destination, in a timely manner. Findings Include: a. Upon random selection of patient record review, one of eight patients selected did not have the correct date of birth transcribed from the initial patient file jacket to the patients electronic report records. b. The patients date of birth as indicated on the file jacket was 12/22/1991 and was manually transcribed into the patients electronic medical record as 12-27-1991 on July 11, 2017 at 11:15 am. c. The manual transcription error was verified and confirmed by the Technical supervisor by interview on July 12, 2018 at approximately 11:00 pm. d. The laboratory reports performing approximately 4500 patient specimens annually. D6079 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(a)(b) 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, record and report test results promptly, accurately and proficiently, and for assuring compliance with the applicable regulations. (a) The laboratory director, if qualified, may perform the duties of the technical supervisor, clinical consultant, general supervisor, and testing personnel, or delegate these responsibilities to personnel meeting the qualifications under 493.1447, 493.1453, 493.1459, and 493.1487 respectively. (b) If the laboratory director reapportions performance of his or her responsibilities, he or she remains responsible for ensuring that all duties are properly performed. This STANDARD is not met as evidenced by: The laboratory director to ensure the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, record and report test results promptly, accurately and proficiently, and for assuring compliance with the applicable regulations. Findings Include: a. The laboratory failed to achieve satisfactory Proficiency Testing scores for event 1, 2018 of at least 80%. See D tag 2020 b. The laboratory director failed to ensure that patient test reports and records are performed accurately. See D tag 5801 c. The laboratory reports performing 4,500 patient specimens annually. -- 2 of 2 --