Omid S Shaye Md

Summary Statement of Deficiencies D2087 ROUTINE CHEMISTRY CFR(s): 493.841(a) (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 Surveyor review of laboratory's proficiency testing (PT) records, and interview with the laboratory technical consultant on December 9, 2025, at 12:00 p. m., the laboratory failed to attain a score of at least 80% of acceptable responses for chloride, creatinine and bilirubin which is an unsatisfactory analyte performance for the testing event. The findings include: 1. The laboratory participated in the AAB PT program for the years 2024 and 2025. The laboratory scored 60% for creatinine at the M3 event and 40% for chloride at the M1 event in 2025. Furthermore, it also scored 20% for bilirubin at the M3 event and 60% for chloride at the M1 event in 2024. Therefore, the accuracy of the patient test results for the above analytes reported by the laboratory during the failed proficiency testing period cannot be assured and might have harmed patients. 2. The laboratory technical consultant on December 9, 2025, at 12:00 p.m. affirmed that the laboratory received less than 80% score. 3. The laboratory's testing declaration form, signed by the laboratory director on 8/15/2025 stated that the laboratory performs approximately 103,306 tests in routine chemistry, annually. D2121 HEMATOLOGY CFR(s): 493.851(a) (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 Surveyor review of laboratory's proficiency testing (PT) records, and interview with the laboratory technical consultant on December 9, 2025, at 12:00 p. m., the laboratory failed to attain a score of at least 80% of acceptable responses for platelet which is an unsatisfactory analyte performance for the testing event. The findings include: 1. The laboratory participated in the AAB PT program for the year 2024. The laboratory scored 60% for platelet at the M3 event in 2024. Therefore, the accuracy of the patient test results for platelet reported by the laboratory during the failed proficiency testing period cannot be assured and might have harmed patients. 2. The laboratory technical consultant on December 9, 2025, at 12:00 p.m., affirmed that the laboratory received less than 80% score at the M3 PT event. 3. The laboratory's testing declaration form, signed by the laboratory director on 8/15/2025 stated that the laboratory performs approximately 54,726 tests in hematology, annually. 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 Surveyor review of laboratory's proficiency testing and patient test records, and interview with the laboratory technical consultant on December 9, 2025, at 12:00 p.m., the laboratory director failed to assure laboratory's compliance with the applicable regulations and thus had impaired the laboratory test quality and potentially harmed patients. The findings include: See D2087 and D2121 D6023 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(6) (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 records from AAB, and interview with the laboratory technical consultant on December 9, 2025, at 12:00 p. m., the laboratory director failed to ensure the maintenance of acceptable levels of analytical performance for chloride, creatinine, bilirubin and platelet test. The findings include: See D2087 and D2121. -- 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 AAB, and interview with the laboratory technical consultant on February 15, 2023, at 11:45 am, the laboratory failed to successfully participate in the proficiency testing program for the WBC differential test. The findings include: 1. The laboratory participated in the AAB PT testing program for the specialty of hematology in the year 2022. However, it received an unsatisfactory score of 47% at the Q2 and Q3 events for WBC differential test, 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 laboratory technical consultant on February 15, 2023, at 11:45 am, 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 -- affirmed that the laboratory did not receive a satisfactory score for the WBC differential test at the Q2 and Q3 events of PT in 2022. 3. The laboratory's testing declaration form, signed by the laboratory director on 1/27/2022, stated that the laboratory performs approximately 8,802 tests, annually. 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 Surveyor review of laboratory's proficiency testing (PT) results from AAB, and interview with the laboratory technical consultant on February 15, 2023, at 11:55 am, the laboratory failed to attain a score of at least 80 percent of acceptable responses for the bicarbonate analyte at Q3 testing event in 2022. The findings include: 1. The laboratory participated in AAB PT testing program for the specialty of chemistry in the year 2022. It received a score of 0% at the Q3 event for the analyte bicarbonate. Therefore, the accuracy of the patients' test results rendered by the laboratory during that time cannot be assured and may have harmed patient. 2. The laboratory technical consultant on February 15, 2023, at 11:55 am, affirmed that the laboratory received 0% score for the analyte bicarbonate at the Q3 PT event in 2022. 3. The laboratory's testing declaration form, signed by the laboratory director on 1/27/2022, stated that the laboratory performs approximately 7,476 bicarbonate tests, 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 AAB, and interview with the laboratory technical consultant on February 15, 2023, at 11:45 am, the laboratory failed to achieve satisfactory performance for the WBC differential test in two consecutive testing events. The findings include: 1. The laboratory participated in AAB PT testing program for the specialty of hematology in the year 2022. However, it received an unsatisfactory score of 47% at the Q2 and Q3 events for WBC differential test that resulted in an unsatisfactory analyte performance. Laboratory's failure to achieve satisfactory performance for the same analyte in two 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 consultant on February 15, 2023, at 11:45 am, affirmed that the laboratory did not receive a satisfactory score for the WBC differential test at the Q2 and Q3 events of PT in 2022. 3. The laboratory's testing declaration form, signed by the laboratory director on 1/27/2022, stated that the laboratory performs approximately 8,802 tests, annually. D5779

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 reviews of analyte performance for the second quarter (Q2-2018), third quarter (Q3-2018) first quarter (Q1-2019), and second quarter (Q2-2019) of the American Association of Bioanalysts (AAB) proficiency testing performance summary records, (18) randomly selected patients' test requisitions and final patient test report (medical records), quality control review from 05/02/2018 to 12/18/2019, proficiency testing (PT) result reports, and interview with the laboratory director(LD) and testing personnel (TP) it was determined that the laboratory failed to attain a score of at least 80 percent of acceptable responses for Sodium (NA),Chloride (CL), Albumin (ALB), Glucose (GLU) and Blood Urea Nitrogen (BUN). The findings included: a. AAB reported Proficiency Testing scores: Analyte Event Score % ALB Q2 2018 60 NA Q3 2018 40 GLUC Q1 2019 40 BUN Q1 2019 60 CL Q2 2019 60 b. Patient test results reviewed covering period from 05/02/2018 to 12/18/2019, the laboratory analyzed and reported Sodium (NA), Chloride (CL), Albumin (ALB), Glucose (GLU) and Blood Urea Nitrogen (BUN tests during the time cited the laboratory received five (5) unsuccessful proficiency scores of Q2, 2018, Q3, 2018, Q1, 2019 and Q2, 2019. c. The Laboratory director and testing person confirmed (1/14 /2019, 14:00) that the laboratory received the above unsuccessful proficiency testing scores. d. The laboratory annual testing declaration (01/10/2020) for routine chemistry (NA, CL, ALB, GLU and BUN included) estimated that a total test volume of 91,806. 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 --