Harbin Clinic, Llc - Main Office

Summary Statement of Deficiencies D0000 A Clinical Laboratory Improvement Amendments (CLIA) recertification survey was completed on April 15, 2025. The laboratory was not in compliance with applicable CLIA requirements found at 42 CFR 493.1 through 42 CFR 493.1780. The following deficiencies were cited: 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 review of the American Proficiency Institute (API) Proficiency Testing (PT) documents and staff interview, the laboratory failed to document

Summary Statement of Deficiencies D0000 A proficiency testing desk review was completed on December 11, 2023. At the time of the review, the laboratory was not in compliance with the Clinical Laboratory Improvement Amendments of 1988, 42 CFR 493.1 through 42 CFR 493.1780. The following condition level deficiencies were cited: D2016 - 42 C.F.R. 493.803 Successful participation [proficiency testing] D6000 - 493.1403 Laboratory Director, Moderate Complexity 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 review of the Centers for Medicare and Medicaid (CMS) 155 Report and review of the American Proficiency Institute (API) proficiency testing reports, 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 -- laboratory failed to successfully participate in 2 out of 3 proficiency testing events resulting in the initial unsuccessful participation in Blood Urea Nitrogen (BUN). Refer to D 2096 D2096 ROUTINE CHEMISTRY CFR(s): 493.841(f) Failure to achieve satisfactory performance for the same analyte or test in 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 review of the CMS 155 report and review of API PT reports, the laboratory failed to demonstrate satisfactory performance in 2 of 3 testing events for BUN, resulting in the initial unsuccessful participation for BUN. Findings: 1. Desk review of CMS 155 reports disclosed the laboratory failed BUN with the following scores: 2023 event 1 = 40% 2023 event 3 = 60% 2. Desk review of the laboratory's proficiency testing reports from API confirmed the laboratory failed the aforementioned analyte. D6000 MODERATE COMPLEXITY LABORATORY DIRECTOR CFR(s): 493.1403 The laboratory must have a director who meets the qualification requirements of 493. 1405 of this subpart and provides overall management and direction in accordance with 493.1407 of this subpart. This CONDITION is not met as evidenced by: Based on review of the CMS 155 report and review of API reports, the laboratory director failed to provide overall management and direction for successful participation in PT. The laboratory director failed to ensure PT samples were tested as required. Refer to D 6016 D6016 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(i) 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)(4)(i) Ensure that the proficiency testing samples are tested as required under Subpart H of this part; This STANDARD is not met as evidenced by: Based on review of the CMS 155 Report and the API PT evaluation reports, the laboratory director failed to ensure successful PT participation. Refer to D 2096 -- 2 of 2 --

Summary Statement of Deficiencies D0000 A Clinical Laboratory Improvement Amendments (CLIA) recertification survey was completed on March 10, 2023. The laboratory was not in compliance with applicable CLIA requirements found at 42 CFR 493.1 through 42 CFR 493.1780. The following deficiencies were cited: D3011 FACILITIES CFR(s): 493.1101(d) Safety procedures must be established, accessible, and observed to ensure protection from physical, chemical, biochemical, and electrical hazards, and biohazardous materials. This STANDARD is not met as evidenced by: Based on the laboratory tour and staff interview, the laboratory failed to ensure the fire extinguisher was inspected, the last inspection date was May 2019. The Findings include: 1. Laboratory tour revealed that the fire extinguisher was last inspected in May 2019. There were 3 fire extinguisher's with the same date. 2. During an interview with the General Supervisor on March 10, 2023 at 12:45 PM, in the General Supervisor's office, confirmed the fire extinguishers were last inspected May 2019. 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 laboratory policy and procedure manual (SOP) review and staff interview, 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 -- the laboratory failed to have the appropriate person evaluate the competency for Testing Personnel(TP). The Findings include: 1. Competency documents revealed the annual competencies were performed but not reviewed by the Laboratory Director for Testing Personnel #1-10 (CMS-209) for 2021 and 2022, as stated in the SOP. 2. During an interview with the General Supervisor (CMS-209) on March 10, 2023 at 1: 00 PM, in the breakroom, confirmed that competencies were performed for the Testing Personnel (TP), but the competencies were not evaluated by the Laboratory Director, as stated from the SOP. D5293 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(b)(c) (b) The general laboratory systems quality assessment must include a review of the effectiveness of

Summary Statement of Deficiencies D0000 A Clinical Laboratory Improvement Amendments (CLIA) recertification survey was completed on January10, 2019. The laboratory was not in compliance with applicable CLIA requirements found at 42 CFR 493.1 through 42 CFR 493.1780. The following deficiency was cited: D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The individual testing or examining the samples and the laboratory director must attest to the routine integration of the samples into the patient workload using the laboratory's routine methods. This STANDARD is not met as evidenced by: Based on review of proficiency test (PT) records and interview with the laboratory general supervisor (GS) , the laboratory testing personnel (TP) and lab director (LD) failed to attest that PT samples were tested in the same manner as patient specimens. Findings include: 1. Review of the PT test records of 2017 revealed: LD and TP failed to sign the Immunology Event #2; LD failed to sign Chemistry Core Event #2 & #3; LD failed to sign Immunology Event #3; LD failed to sign Microbiology Event #3. 2. Review of the PT test records of 2018 revealed: TP failed to sign the Microbiology Event #1; LD failed to sign Chemistry Core Events #1, #2, & #3. 3. Interview with the GS on 1/10/19 in her office at approximately 3 PM, confirmed the absence of the aforementioned signatures for the 2017-2018 PT attestations. D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) The laboratory must define criteria for those conditions that are essential for proper storage of reagents and specimens, accurate and reliable test system operation, and test result reporting. The criteria must be consistent with the manufacturer's 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 -- instructions, if provided. These conditions must be monitored and documented and, if applicable, include the following: (1) Water quality. (2) Temperature. (3) Humidity. (4) Protection of equipment and instruments from fluctuations and interruptions in electrical current that adversely affect patient test results and test reports. This STANDARD is not met as evidenced by: Based on maintenance document review and staff interview, the laboratory failed to monitor and document room temperature and humidity as required. Findings include; 1. Maintenance document review revealed there were no temperature or humidity logs for the laboratory area for 2017, 2018, and 2019 thus far. 2. An interview with Staff #1 (CMS 209) in the general supervisor's office on 1/10/19 at approximately 3:30 p.m. confirmed the laboratory area room temperature and humidity were not monitored nor documented for 2017, 2018, and 2019 thus far. D6004 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(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, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (a) The laboratory director, if qualified, may perform the duties of the technical consultant, clinical consultant, and testing personnel, or delegate these responsibilities to personnel meeting the qualifications of 493.1409, 493.1415, and 493.1421, 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: Based on testing personnel (TP) document review and staff interview, the laboratory director (LD) failed to delegate TP assessment responsibilities to qualified TP as required. Findings include: 1. TP competency document review all TP competencies (initial, 6-month, annual) for 2017 and 2018 were performed by unqualified TO due to lack of educational qualifications. 2. An interview with Staff #1 (CMS 209) in the general supervisor's office on 1/10/19 at approximately 3:30 p.m. confirmed the aforementioned competencies were performed by unqualified TP. -- 2 of 2 --