Ken C Arakawa Md, Inc

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: The surveyor's review of laboratory records, and confirmation by the general supervisor during an interview on 12/04/2025 at 11:00 AM revealed the laboratory failed to follow its written policy and procedure to assess the competency of 1 of 1 general supervisor in 2023 and 2024. The general supervisor stated that an annual competency assessment was not performed since 2023 when testing personnel responsibilities were removed from the role of general supervisor. The laboratory performs an annual volume of 438 general immunology tests, 30,995 routine chemistry and urinalysis tests, and 22,188 hematology tests. D5211 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(a) The laboratory must review and evaluate the results obtained on proficiency testing performed as specified in subpart H of this part. This STANDARD is not met as evidenced by: The surveyor's review of American Proficiency Institute (API) proficiency testing records, and an interview with the general supervisor and 1 of 1 testing personnel on 12/04/2025 at 11:00 AM revealed the laboratory failed to review and evaluate an unacceptable phosphorus result in the second Chemistry Core event of 2025. The findings include: 1. The laboratory reported a phosphorus result of 4.9 for Specimen 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 -- CH-07. The expected result range was 3.9 to 4.8. 2. The laboratory performs an annual volume of 280 phosphorus tests. D6092 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(4)(iv) (e)(4)(iv) An approved

Summary Statement of Deficiencies 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 review of laboratory proficiency testing (PT) records and an interview with the general supervisor on 11/9/2023 at 11:00 AM, it was revealed that the laboratory failed to successfully participate in the American Association of Bioanalysts Medical Laboratory Evaluation's (AAB MLE) 2022 qualitative Rheumatoid Factor (RF) PT program. The findings include: 1. The laboratory failed to achieve satisfactory performance scores for its 2022 AAB MLE RF testing in two out of three consecutive PT events. Refer to D tag D2084. D2084 GENERAL IMMUNOLOGY Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 4 -- CFR(s): 493.837(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 a review of laboratory PT records and an interview with the general supervisor on 11/9/2023 at 11:00 AM, it was revealed that the laboratory failed to achieve satisfactory performance scores for AAB MLE RF testing in two out of three consecutive PT events in 2022. The laboratory performed annual volume of 189 RF tests. The findings include: 1. The laboratory received a zero score for its nonparticipation in the first RF PT testing event. The general supervisor stated the laboratory notified the PT program that the laboratory was not reporting, "testing discontinued due to manufacturing issues". 2. The laboratory received a "Dc" score for the second RF PT testing event. The general supervisor stated the laboratory was not aware that the PT program discontinued sending RF PT samples to the laboratory for testing. 3. The general supervisor stated the CLIA state agency was not notified within the time frame for submitting PT results of the circumstances associated with its failure to participate in the first and second testing events of 2022.. D5215 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(b)(2) The laboratory must verify the accuracy of any analyte, specialty or subspecialty assigned a proficiency testing score that does not reflect laboratory test performance (that is, when the proficiency testing program does not obtain the agreement required for scoring as specified in subpart I of this part, or the laboratory receives a zero score for nonparticipation, or late return or results). This STANDARD is not met as evidenced by: Based on a review of laboratory (PT) records and an interview with the general supervisor on 11/9/2023 at 11:00 AM, it was revealed that the laboratory failed to verify the accuracy of RF testing when it did not participate in the first and second AAB MLE RF PT testing events of 2022. The laboratory performed annual volume of 189 RF tests. 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 a review of laboratory PT records and an interview with the general supervisor on 11/9/2023 at 11:00 AM, it was revealed the laboratory failed to follow -- 2 of 4 -- written policies and procedures for an ongoing mechanism to monitor, assess, and correct problems identified with its unsuccessful participation in AAB MLE 2022 RF PT events. Refer to D tag D2084. 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 a review of laboratory maintenance records and an interview with the general supervisor on 11/9/2023 at 10:30 AM, it was revealed the laboratory failed to perform annual preventive maintenance on its Olympus CHS microscope SN 0K0050 in 2021, 2022 and 2023. The general supervisor stated the laboratory did not schedule this annual activity with their maintenance vendor. The laboratory performed an annual volume of 796 urine sediment examinations and 121 hematology manual differentials. D6091 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(4)(iii) The laboratory director must ensure all proficiency testing reports received are reviewed by the appropriate staff to evaluate the laboratory's performance and to identify any problems that require

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 confirmation by the general supervisor on 12/29/2021 at 10:00 AM, 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. 2021 annual competency assessments for the general supervisor and testing personnel were not performed. 2. A 6 month competency assessment was not performed on the testing personnel whose initial assessment was completed on 09/23/2020. 3. A new laboratory director was assigned to the laboratory by the director of operations of a pathology group on 08/01/2021. The director of operations stated on 10/04/2021 that the pathology group was "still working on other documents" necessary for the 2021 annual competency assessments. 4. The general supervisor and testing personnel performed 699 general immunology tests, 41,164 routine chemistry and urinalysis tests, and 34,296 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 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 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 -- 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 confirmation by the general supervisor on 12/29/2021 at 10:00 AM, it was determined that the laboratory director failed to ensure that 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 --

Summary Statement of Deficiencies D2006 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b) The laboratory must examine or test, as applicable, the proficiency testing samples it receives from the proficiency testing program in the same manner as it tests patient specimens. This testing must be conducted in conformance with paragraph (b)(4) of this section. If the laboratory's patient specimen testing procedures would normally require reflex, distributive, or confirmatory testing at another laboratory, the laboratory should test the proficiency testing sample as it would a patient specimen up until the point it would refer a patient specimen to a second laboratory for any form of further testing. This STANDARD is not met as evidenced by: Based on a review of Proficiency Testing reporting records and an interview with the laboratory supervisor on 8/13/2019, it was determined that the laboratory failed to test chemistry samples it receives from the proficiency testing program in the same manner as it tests patient specimens. Findings include: 1. The laboratory participated in the American Proficiency Institute proficiency program for Chemistry in 2018 and 2019. In the first, second, and third proficiency testing events of 2018, and the first and second proficiency testing events of 2019, survey samples were tested twice, once by each of two testing personnel. Results reported to the proficiency testing program on the above events were a combination of results selected from the two individual testing personnel. For example in the 2018 first survey event, Testing Personnel A's results were reported for the following analytes from CH-01: Bilirubin Total, Calcium Total, Cholesterol HDL, Cholesterol Total, Creatine Kinase, Glucose, Cholesterol LDL, Triglycerides, Phosphorus, Uric Acid, Sodium, and Potassium. Testing Personnel B's results were reported for the following analytes from CH-01: ALT, AST, and Creatinine. 2. The laboratory supervisor stated during interview on 8/13/19, that patient samples for chemistry testing are performed and resulted by a single testing personnel. 3. The laboratory supervisor confirmed during interview on 8/13 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 -- /19, that samples for chemistry Proficiency Testing during the listed events were not tested in the same manner as patient samples. 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 a 8/13/2019 review of laboratory maintenance records and an interview with the laboratory supervisor at 10:30 a.m., it was determined that the laboratory failed to perform and document weekly ACE Alera Wasserman maintenance activities. The findings include: 1. The ACE Clinical Chemistry Maintenance Log lists the following weekly tasks: 1) Inspect air filters, 2) clean exterior surfaces of the system, and 3) Clean reference housing. 2. Documentation of weekly maintenance performance was not available for review for: a. 2018: 2 of 4 weeks in February (2/5-2/10 and 2/19-2 /24), 1 of 4 weeks in March (3/26-3/31), 1 of 5 weeks in May (5/7-5/12), 1 of 4 weeks in June (6/11-6/16), 1 of 4 weeks in July (7/2-7/7), 1 of 4 weeks in October (10/8-10 /13), and 2 of 4 weeks in November (11/12-11/17 and 11/19-11/24) b. 2019: 1 of 4 weeks in February (2/11-2/16), 2 of 4 weeks in March (3/4-3/9 and 3/25-3/30), 1 of 4 weeks in April (4/8-4/13), 1 of 5 weeks in May (5/27-6/1), and 2 of 4 weeks in July (7 /1-7/6 and 7/22-7/27) 3. The laboratory supervisor stated that chemistry testing was performed on 35-40 patients per month. 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 a review of Proficiency Testing reporting records and an interview with the laboratory supervisor on 8/13/2019, it was determined that the laboratory director failed to ensure that chemistry samples it receives from the American Proficiency Institute proficiency testing program were tested in the same manner as it tests patient specimens. Refer to D2006. D6023 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(6) The laboratory director is responsible for the overall operation and administration of -- 2 of 3 -- 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 8/13/2019 review of laboratory maintenance records and an interview with the laboratory supervisor at 10:30 a.m., it was determined that the laboratory failed to ensure the establishment and maintenance of acceptable levels of analytical performance for its ACE Alera Wasserman chemistry testing . Refer to D5433. -- 3 of 3 --