South Western Women's Options, Llc

Summary Statement of Deficiencies D0000 An onsite recertification survey conducted on February 29, 2024, at Curtis Boyd, MD PC found the laboratory to be in compliance with the CLIA regulations found at 42 CFR, Part 493 Laboratory Requirements, with standard deficiencies cited. 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 review of CMS 209 form, American Proficiency Institute (API) proficiency testing (PT) attestation form, and interview, the laboratory failed to ensure PT samples were entered into routine laboratory testing for 3 of 3 PT events in 2023. Findings included: 1. Review of CMS 209 listed 6 testing personnel (TP) performing moderate complexity testing. 1. Review of the API proficiency testing attestation forms from 2023 revealed the following: 1. Event 1 of 2023: - TP #2: Tested samples 1-5 - TP #3: Tested samples 1-5 - TP #4: Tested samples 1-5 - TP #5: Tested samples 1-5 - TP #6: Tested samples 1-5 - Laboratory Director: Tested samples 1-5 2. Event 2 of 2023: - TP #3: Tested samples 6, 7, 8, 9, 10 - TP #4: Tested samples 6, 7, 8, 9, 10 - TP #6: Tested samples 6, 7, 8, 9, 10 3. Event 3 of 2023: - TP #2: Tested samples 11, 12, 13, 14, 15 - Laboratory Director: Tested samples 11, 12, 13, 14, 15 - TP #3: Tested samples 11, 12, 13, 14, 15 - TP #5: Tested samples 11, 12, 13, 14, 15 2. Interview on 2 /29/2024 at 10:30am with TP #2 stated, the facility's regular work routine is to have 1 testing personnel test a patient sample and it is not repeated or ran multiple times by other personnel unless results need to be verified, confirming the findings. D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(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 2 -- 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 American Proficiency Institute (API) proficiency testing (PT) records and interview, the laboratory failed to have the laboratory director or assigned designee sign the attestation forms for 2 of 3 PT events in 2023. Findings included: 1. Review of the API proficiency testing attestation forms from 2023 revealed the following: 1. Event 1 of 2023: Laboratory section signed by testing personnel #2. 2. Event 2 of 2023: Laboratory section signed by testing personnel #2 Laboratory director or assigned designee did not sign attestation form. 2. Interview on 2/29/2024 at 10:30am with testing person #2 confirmed the findings. 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 review of American Proficiency Institute (API) proficiency testing (PT) review and

Summary Statement of Deficiencies D0000 The following standard deficiences were cited as the results of a recertification survey on 08/02/2022. This facility was found NOT to be in compliance with the CLIA regulations found at 42 CFR for the specialties/subspecialties in which it was surveyed. 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 the review of the 2020 - 2022 proficiency testing (PT) records, Personnel Report Form CMS-209, and interview with the technical consultant, the laboratory failed to ensure that the PT samples were rotated amongst testing personnel who routinely perform Rh (immunohematology) testing for 3 of 3 PT events in 2020, 3 of 3 PT events in 2021, and 1 of 1 PT event in 2022. Findings included: 1. Review of the 2020 - 2022 attestation forms for the American Proficiency Institute (API), revealed testing personnel - 2 (TP2) tested the proficiency samples for 3 of 3 PT events in 2020, and 3 of 3 PT events in 2021, and 1 of 1 PT event in 2022. 2. Review of the Personnel Report Form CMS-209 completed by the laboratory indicated a total of 13 testing personnel. 3. During interview on 08/02/2022 at 2:00 pm, the technical consultant confirmed the above findings. 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 The following deficiency was cited as the result of a recertification survey on 10/22 /19 for 42 CFR part 493 Laboratory Requirements. 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 the review of the laboratory policy/procedure manual and the CMS 116 (Application for Certification) dated 02/18/16, the laboratory director failed to review and approve 9 of 10 laboratory policies or procedures since becoming the laboratory director. Findings are: A. Review of the laboratory procedure manual revealed the laboratory director failed to review and approve 9 of 10 policies/procedures: Staff Quality Assurance Reviews Lab Personnel Responsibilities Technical Consultant Responsibilities Clinical Consultant Responsibilities Lab Quality Assurance:Director /Supervisor Quality Control Measures External Controls: Rh Testing Quality Assurance Protocols Laboratory Testing B. All 10 of the policies/procedures were signed annually by the Laboratory Supervisor; 09/06/16, 10/03/17, 11/06/18, and 10 /01/19. C. Review of the CMS Form 116 submitted following the certification survey on 02/18/16 documented the appointment of the current laboratory director. D. These findings were confirmed by the Laboratory Supervisor on 10/22/19 at 10:45 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 1 --

Summary Statement of Deficiencies No Tags No deficiency details available. 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 --