Osteopathic Medical Associates Of Nevada

Summary Statement of Deficiencies D0000 This Statement of Deficiencies was created as a result of an on-site CLIA recertification survey conducted at your facility on August 20, 2024. The findings and conclusions of any investigation by the Division of Public and Behavioral Health shall not be construed as prohibiting any criminal or civil investigations, actions or other claims for relief that may be available to any party under applicable federal, state, or local laws. D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: Based on a review of the 2023 American Proficiency Institute (API) Proficiency Testing (PT) records, and an interview with the lead medical assistant, the laboratory failed to ensure that the laboratory verified the accuracy of the MCH and MCHC results at least twice annually. Findings include: 1. A review of the 2023 API PT records revealed that the laboratory achieved unacceptable scores for the MCH. The MCH score for the 2023 test event numbers one and two was 40%. The MCH score for the 2023 test event number three was 60%. 2. A review of the 2023 API PT records revealed that the laboratory achieved unacceptable scores for the MCHC. The MCHC score for the 2023 test event number two was 40%. The MCHC score for the 2023 test event number three was 60%. 3. The findings were confirmed during an interview with the lead medical assistant conducted on August 20, 2024 at approximately 1:45 PM. The laboratory performs approximately 1000 hematology tests annually. D5293 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(b)(c) 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 -- (b) The general laboratory systems quality assessment must include a review of the effectiveness of

Summary Statement of Deficiencies D0000 This Statement of Deficiencies was created as a result of an on-site CLIA recertification survey conducted at your facility on September 2, 2022. The findings and conclusions of any investigation by the Division of Public and Behavioral Health shall not be construed as prohibiting any criminal or civil investigations, actions or other claims for relief that may be available to any party under applicable federal, state, or local laws. D6053 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) The technical consultant is responsible for evaluating and documenting the performance of individuals responsible for moderate complexity testing at least semiannually during the first year the individual tests patient specimens. This STANDARD is not met as evidenced by: Based on a review of the laboratory records for training and competency assessment and an interview with the lead medical assistant, the technical consultant failed to ensure that semi-annual training and competency assessment was completed for new personnel during the first year of employment. Findings include: 1. A review of the training and competency assessment forms for the laboratory testing personnel revealed that there was no documentation of semi-annual training and competency assessment for one of two testing personnel during the first year of employment. 2. The finding was confirmed during an interview with the lead medical assistant conducted on September 2, 2022 at approximately 9:30 AM. The laboratory performs approximately 1000 hematology tests annually. 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 D0000 This Statement of Deficiencies was created as a result of an on-site CLIA recertification survey conducted at your facility on March 3, 2021. The findings and conclusions of any investigation by the Division of Public and Behavioral Health shall not be construed as prohibiting any criminal or civil investigations, actions or other claims for relief that may be available to any party under applicable federal, state, or local laws. D2007 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The samples must be examined or tested with the laboratory's regular patient workload by personnel who routinely perform the testing in the laboratory, using the laboratory's routine methods This STANDARD is not met as evidenced by: Based on a review of the American Proficiency Testing Institute (API) proficiency testing records for testing years 2018, 2019, and 2020, and an interview with testing personnel #1 on the CMS 209 form, the director failed to ensure that the proficiency testing samples were tested by all personnel who routinely perform the testing in the laboratory. Findings include: The laboratory failed to rotate the proficiency testing specimens for the Hematology 2018 testing events two and three, the 2019 testing event equivalent number one, and API testing events two, and three, and the 2020 testing events one, two and three among all testing personnel in the laboratory. The specimens were tested by the same testing personnel for each event. The testing personnel #1 confirmed the finding during an interview conducted on 3/3/21 at approximately 10:30 am. The laboratory performs approximately 1000 hematology patient tests annually. D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) 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 -- For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document maintenance as defined by the manufacturer and with at least the frequency specified by the manufacturer. This STANDARD is not met as evidenced by: Based on a review of laboratory maintenance logs for the Sysmex XP-300 Hematology analyzer for testing years 2018, 2019, 2020 and 2021, and an interview with testing personnel #1 from the CMS 209 form, the director failed to ensure that all maintenance was performed and documented with the frequency specified by the manufacturer of the instrument. Findings include: The laboratory failed to record the weekly maintenance for the Sysmex XP-300 Hematology instrument during the months of July, 2018, and May, 2019. Testing personnel #1 confirmed the finding during an interview conducted on 3/3/21 at approximately 10:00 am. The laboratory performs approximately 1000 hematology patient tests annually. D5431 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(2) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document function checks as defined by the manufacturer and with at least the frequency specified by the manufacturer. Function checks must be within the manufacturer's established limits before patient testing is conducted. This STANDARD is not met as evidenced by: Based on a random review of daily background check and quality controls performed during testing years 2018, 2019, and 2020 and an interview with testing personnel #1 from the CMS 209 form, the director failed to ensure that the function checks defined by the manufacturer were performed and documented with the frequency specified by the manufacturer. Findings include: A random review of eight patient testing dates from 7/3/2018 through 12/15/2020 revealed that six of eight patient testing dates had no evidence of the required daily background check for the Sysmex XP-300. The finding was confirmed during an interview with the testing personnel #1 on 3/3/21 at approximately 10:45 am. The laboratory performs approximately 1000 hematology patient tests annually. D6021 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(5) 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)(5) Ensure that quality assessment programs are established and maintained to assure the quality of laboratory services provided. This STANDARD is not met as evidenced by: Based on a review of the laboratory quality assessment program documentation from May, 2018 through February, 2021, and an interview with testing personnel #1, the director failed to ensure that the established quality assessment program was -- 2 of 3 -- maintained to assure the quality of laboratory services provided. Findings include: The laboratory failed to complete the monthly quality assessment as described in the director approved policy and procedure manual for the months of July, 2018, August, 2018, October, 2018, December, 2018, May, 2019 through December 2019, April, 2020, May 2020, and August, 2020 through February 2021. Testing personnel #1 confirmed the findings during an interview conducted on 3/3/21 at approximately 10: 45 am. The laboratory performs approximately 1000 hematology patient tests annually. -- 3 of 3 --

Summary Statement of Deficiencies D0000 This Statement of Deficiencies was created as a result of an on-site CLIA recertification survey conducted at your facility on June 21 and 22, 2018. The findings and conclusions of any investigation by the Division of Public and Behavioral Health shall not be construed as prohibiting any criminal or civil investigations, actions or other claims for relief that may be available to any party under applicable federal, state, or local laws. 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 the American Proficiency Institute (API) proficiency testing results for hematology for testing years 2016, 2017 and 2018 and an interview with the medical assistant, the laboratory failed to test proficiency testing samples in the same manner that the laboratory tests patient specimens. Findings include: 1. The laboratory failed to perform the API first event hematology proficiency testing in the same manner that the laboratory performs patient hematology testing. 2. The laboratory had ceased patient hematology testing from 10/31/17 through 5/04/18 due to the hematology reagents having expired. The laboratory performed the API hematology first event 2018 on 3/22/18 using expired hematology reagents. 3. The laboratory's API proficiency test results revealed that the RDW was 0% with 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 4 --