Razmik Ohanjanian, Md, Inc

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 review of the Certification and Survey Provider Enhanced Reporting (CASPER) -0155D and API - American Proficiency Institute (API) records (2023-2 and 2024-1), the laboratory failed tjo successfully participate in a proficiency testing program approved by HHS, for each specialty, subspecialty or test which the laboratory is certified under CLIA. The laboratory failed to successfully participate in the analyte Hemoglobin (Hgb). Refer to D2130. D2130 HEMATOLOGY CFR(s): 493.851(f) 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 -- Failure to achieve satisfactory performance for the same analyte in two consecutive 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 Certification and Survey Provider Enhanced Reporting (CASPER) Report 0155D Individual Laboratory Profile and API - American Proficiency Institute (API) report, the laboratory failed to achieve satisfactory performance for consecutive events (2023-2 and 2024-1) for Hgb. The finding include: 60% on the 2023 second event 0% on the 2024 first event A review of the 2023 and 2024 scores from API - American Proficiency Institute confirmed the above findings. 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 a proficiency testing desk review of the CASPER 0155D report and API records for 2023-2 and 2024-1 events, the laboratory director failed to provide overall management and direction of the laboratory services. Refer to D6016. 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 proficiency testing desk review of CASPER 0155D report and API records for 2023-2 and 2024-1 events, the laboratory director failed to ensure successful participation in an HHS approved proficiency testing program. Refer to D2130. -- 2 of 2 --

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 Surveyor review of laboratory's proficiency testing (PT) results from American Proficiency Institute (API), and interview with the laboratory testing person on November 6, 2023, at 2:00 pm, the laboratory failed to successfully participate in the proficiency testing program for the platelet count test. The findings include: 1. The laboratory participated in the API PT testing program for the specialty of hematology in the year 2022 and 2023. However, it received an unsatisfactory score of 60% at the 3rd event in 2022 and at the 2nd event in 2023 for the platelet count test which resulted in an unsuccessful PT participation. Therefore, the accuracy of the patients' test results rendered by the laboratory during that time cannot be assured. 2. 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 3 -- laboratory testing person on November 6, 2023, at 2:00 pm, affirmed that the laboratory did not receive a satisfactory score for the platelet count test at the 3rd event in 2022 and at the 2nd event in 2023. 3. The laboratory's testing declaration form, signed by the laboratory director on 11/6/2023, stated that the laboratory performs approximately 4,000 tests in hematology, annually. D2130 HEMATOLOGY CFR(s): 493.851(f) Failure to achieve satisfactory performance for the same analyte in two consecutive events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on Surveyor review of laboratory's proficiency testing (PT) results from American Proficiency Institute (API), and interview with the laboratory testing person on November 6, 2023, at 2:00 pm, the laboratory failed to achieve satisfactory performance for the platelet count test in two out of three consecutive events. The findings include: 1. The laboratory participated in in the API PT testing program for the specialty of hematology in the year 2022 and 2023. However, it received an unsatisfactory score of 60% at the 3rd event in 2022 and at the 2nd event in 2023 for the platelet count test that resulted in an unsatisfactory analyte performance. Laboratory's failure to achieve satisfactory performance for the same analyte in two out of three consecutive events resulted in an unsuccessful PT performance. Therefore, the accuracy of the patients' test results rendered by the laboratory during that time cannot be assured. 2. The laboratory technical supervisor on November 6, 2023, at 2:00 pm, affirmed that the laboratory did not receive a satisfactory score the platelet count test at the 3rd event in 2022 and at the 2nd event in 2023. 3. The laboratory's testing declaration form, signed by the laboratory director on 11/6/2023, stated that the laboratory performs approximately 4,000 tests in hematology, annually. 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 Surveyor review of laboratory's proficiency testing (PT) and patient sample testing records, and interview with the laboratory testing person during an onsite survey of the laboratory on November 6, 2023, at 2:00 pm, and the severity and the number of deficiencies found and cited herein, it was determined that the laboratory director failed to provide effective direction over the operation of the laboratory, hence the Condition: Laboratories performing moderate complexity testing; laboratory director was not met. The laboratory director's failure to provide direction over the laboratory operation has a consequence of potential erroneous test result reporting and patient harm. The findings include: The laboratory director failed to ensure the maintenance of an acceptable levels of analytical performance for the platelet count test. (See D6023) D6023 LABORATORY DIRECTOR RESPONSIBILITIES -- 2 of 3 -- 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 Surveyor review of laboratory's proficiency testing (PT) results from American Proficiency Institute (API), and interview with the laboratory technical supervisor on November 6, 2023, at 2:00 pm, the laboratory failed to achieve satisfactory performance for platelet count test in two out of three consecutive PT events. The findings include: See D2130. -- 3 of 3 --

Summary Statement of Deficiencies D2087 ROUTINE CHEMISTRY CFR(s): 493.841(a) Failure to attain a score of at least 80 percent of acceptable responses for each analyte in each testing event is unsatisfactory analyte performance for the testing event. This STANDARD is not met as evidenced by: Based on review of the American Proficiency Institute (API) proficiency testing records and interview with the testing personnel (TP); it was determined that the laboratory failed to attain a score of at least 80 percent of acceptable responses for multiple chemistry analytes for the years 2019 and 2020. The finding included: 1. Based on review of PT records for 2019 and 2020, API reported the following unsatisfactory scores for the following analytes: Analyte Event Score Reported ALT (SGPT) Q1-2019 60% ALT (SGPT) Q1-2020 60% AST (SGOT) Q3-2020 60% Total Bili Q1-2020 60% HDL Cholesterol Q1-2019 40% Creatine Q3-2020 60% T4 Thyroxine Q2-2020 60% 2. Based on the laboratory testing declaration submitted at the time of the survey on 01/05/2020 the laboratory analyzed and reported approximately 15,300 Routine Chemistry tests for each year during the time the laboratory had unsatisfactory proficiency testing results. 3. The TP affirmed 01/05 /2020 at approximately 1:30 p.m. that the laboratory received the above unsatisfactory proficiency testing scores D2098 ENDOCRINOLOGY CFR(s): 493.843(a) Failure to attain a score of at least 80 percent of acceptable responses for each analyte in each testing event is unsatisfactory analyte performance for the testing event. This STANDARD is not met as evidenced by: 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 -- Based on reviews second quarter (Q2-2020) of the American Proficiency Institute (API) proficiency testing records, random patient sampling test results, and interview with the laboratory testing personnel (TP); it was determined that the laboratory failed to attain a score of at least 80 percent of acceptable responses for T4 (Thyroxine) analyte. The findings included: 1. Q2-2020, API reported an unacceptable score of 60% for T4 analyte. 2. For five (5) out of five (5) random patient sampling test results reviewed covering period from 03/27/2020 to 08/27/2020, the laboratory analyzed and reported an unknown number of T4 quantitative tests during the period the laboratory received the unsatisfactory proficiency testing score. 3. The TP confirmed on 01/05 /2021 at approximately 1:40 p.m. that the laboratory received the above unsatisfactory proficiency testing score for T4. D3001 FACILITIES CFR(s): 493.1101(a)(1) The laboratory must be constructed, arranged, and maintained to ensure the space, ventilation, and utilities necessary for conducting all phases of the testing process. This STANDARD is not met as evidenced by: Based on observation of the laboratory testing area and interview with the testing personnel (TP), it was determined that the laboratory testing area failed to be constructed, arranged, and maintained to ensure the space, ventilation, and utilities necessary for conducting all phases of the clinical testing process. The findings included: 1. The laboratory area consist of a small room (approximately 200-300 square feet) which serves to house the automated testing instruments: Beckman Coulter for Hematology testing, the Chemistry analyzer, and the Immunolite 1,000; the testing personnel's office, as well as storage area for reagents, documents, and patients' results and data. 2. The space designated for the laboratory appears to be insufficient. The room is crowded, difficult to maintain, inappropriate for proper traffic flow, and fails to provide sample integrity and quality for testing, in addition to increase risk of contamination of paperwork and possible cross-contamination of samples. 3. The TP affirmed on January 5, 2021 at approximately 2:00 p.m. that the laboratory failed to be constructed, arranged and maintained to ensure the space, ventilation, and utilities necessary for conducting all phases of the testing process. 4. The laboratory's testing declaration form, signed by the laboratory director on January 5, 2021, stated that the laboratory performs approximately 19,300 tests annually. D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: Based on the lack of laboratory written policies and procedures and interview with the testing personnel (TP), it was determined that the laboratory failed to have available and follow written procedures for Hematology, Endocrinology and Routine Chemistry test procedures performed in the laboratory. The findings included: 1. On the day of the survey 01/05/2021 at approximately 1:30 p.m. the laboratory failed to provide -- 2 of 3 -- written policies and procedures for Hematology, Endocrinology, and Routine Chemistry for the test procedures performed in the laboratory. 2. For ten (10) out of ten (10) random patient test results reviewed covering period from 08/23/2018 to 08 /27/2020, all the patients had tests ordered, analyzed, and reported for which the laboratory had no written policies and procedures available. 3. The TP confirmed on 01/05/2021 at approximately 2:00 p.m. that the laboratory did not have written policies and procedures available for Hematology, Endocrinology, and Routine Chemistry test performed in the laboratory. D6010 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(2) 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)(2) Ensure that the physical plant and environmental conditions of the laboratory are appropriate for the testing performed. This STANDARD is not met as evidenced by: Based on direct observation of the laboratory operation, test performance, documents and reagent storage, and interview with the testing personnel; it was determined that the laboratory director failed to ensure that the physical plant, space, organization, and environmental conditions of the laboratory are appropriate for the testing performed. See D3001. D6031 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(13) 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)(13) Ensure that an approved procedure manual is available to all personnel responsible for any aspect of the testing process; This STANDARD is not met as evidenced by: Based on direct observation and interview with the laboratory testing personnel it was determined that the laboratory director failed to ensure that an approved procedure manual is available at all times to all personnel responsible for any aspect of the testing process. See D5041. -- 3 of 3 --

Summary Statement of Deficiencies D2087 ROUTINE CHEMISTRY CFR(s): 493.841(a) Failure to attain a score of at least 80 percent of acceptable responses for each analyte in each testing event is unsatisfactory analyte performance for the testing event. This STANDARD is not met as evidenced by: Based on review of the laboratory's proficiency testing (PT) result reports, and interview with the laboratory staff, it was determined the laboratory failed to attain a score of at least 80 percent of acceptable responses for each analyte in each testing event was unsatisfactory analyte performance for the testing event. The findings included: a. The laboratory performed routine chemistry including, but not limited to the following testing, ALT and ASTand elected to enroll its PT program with American Proficiency Institute (API) to meet the CLIA requirement to ensure the accuracy of the testing performance. b. The laboratory attained a scores of 0 % and 60 % for the analyte AST and ALT in the 3rd 2017 and the 1st 2018 PT events, respectively. c. The laboratory failed to attain at least 80% for AST and ALT in the PT events which was unsatisfactory analyte performance for the testing event. c. The laboratory performed AST and ALT in approximately 84 patient samples each month. d. The laboratory staff affirmed (5/23/18 @ 12:15PM) that the laboratory attained a score of 0 % for AST in the 3rd 2017 and 60 % for ALT in the 1st 2018 PT events which was unsatisfactory analyte performance for the testing event. D2098 ENDOCRINOLOGY CFR(s): 493.843(a) Failure to attain a score of at least 80 percent of acceptable responses for each analyte in each testing event is unsatisfactory analyte performance for the testing event. 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 review of the laboratory's proficiency testing (PT) result reports, and interview with the laboratory staff, it was determined the laboratory failed to attain a score of at least 80 percent of acceptable responses for each analyte in each testing event was unsatisfactory analyte performance for the testing event. The findings included: a. The laboratory performed T3 Uptake and elected to enroll its PT program with American Proficiency Institute (API) to meet the CLIA requirement to ensure the accuracy of the testing performance. b. The laboratory attained a score of 90% for the analyte T3 uptake in the 2nd 2017 PT event which was unsatisfactory analyte performance for the testing event. c. The laboratory performed T3 uptake in approximately 9 patient samples each month. d. The laboratory staff affirmed (5/23/18 @ 12:15PM) that the laboratory attained a score of 90% for the 2nd 2017 PT event which was unsatisfactory analyte performance for the testing event. 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 laboratory 's proficiency testing (PT) result reports, and interview with the laboratory staff, it was determined that the laboratory director failed to ensure that the proficiency testing samples were tested as required under Subpart H of 42 CFR 493. The findings included: a. The laboratory performed nowaived routine chmeistry and endocrinology testing, including, but not limited to AST and ALT b. The laboratory failed to attain a score of at least 80% for each analyte to meet the CLIA requirements for accuracy. c. See D-2087 and D-2098 -- 2 of 2 --