Whole Woman's Health Alexandria

Summary Statement of Deficiencies D0000 An off-site CLIA proficiency testing desk review of Whole Woman's Health Alexandria was completed on May 21, 2024 by a Medical Facilities Inspector of the Virginia Department of Health's Office of Licensure and Certification. The laboratory was surveyed under 42 CFR part 493 CLIA Regulations. The laboratory was found not in compliance with the following Conditions under 42 CFR part 493 CLIA Regulations: D2016 - 42 C.F.R. 493.803 (a)(b)(c) Condition- Successful Participation. D6000 - 42 C.F.R. 493.1403 Condition-Laboratories performing moderate complexity testing: Laboratory Director. 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: 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 a proficiency testing (PT) desk review of the laboratory's Certification and Survey Provider Enhanced Reporting (CASPER)-0155 report and American Proficiency Institute (API) records for 2023 (Events one, two and three), and 2024 (Event one), the laboratory failed to successfully participate in a proficiency testing program approved by Health and Human Services (HHS) for the Immunohematology subspecialty of ABO Group and D (RHO) typing and the analyte D (RHO). Refer to D2162 and D2163. D2162 ABO GROUP AND D(RHO) TYPING CFR(s): 493.859(f) Failure to achieve satisfactory performance for the same analyte 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 proficiency testing (PT) desk review of the laboratory's Certification and Survey Provider Enhanced Reporting (CASPER)-0155 report and American Proficiency Institute (API) evaluation reports for 2023 (Events one, two and three), and 2024 (Event one), the laboratory failed to achieve satisfactory performance (100%) for the analyte D (RHO) for three of four events reviewed. The laboratory had unsatisfactory scores for D (RHO) for 2023 Event one (1), 2023 Event two (2), and 2024 Event one (1) resulting in non-initial unsuccessful participation. The findings include: 1. Review of the CASPER-0155 report revealed the following unsatisfactory scores: 2023 Event 1: D (RHO) = 0%, 2023 Event 2: D (RHO) = 0%, 2024 Event 1: D (RHO) = 80%. 2. A review of the laboratory's 2023 and 2024 API PT scores for the analyte D (RHO) confirmed the above findings resulting in non-initial unsuccessful participation for the analyte D (RHO). D2163 ABO GROUP AND D(RHO) TYPING CFR(s): 493.859(g) Failure to achieve an overall testing event score of satisfactory for 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 proficiency testing (PT) desk review of the laboratory's Certification and Survey Provider Enhanced Reporting (CASPER)-0155 report and American Proficiency Institute (API) evaluation reports for 2023 (Events one, two and three), and 2024 (Event one), the laboratory failed to achieve satisfactory performance (100%) for the Immunohematology subspecialty of ABO Group and D (RHO) typing for three of four events reviewed. The laboratory had unsatisfactory scores for ABO Group and D (RHO) typing for 2023 Event one (1), 2023 Event two (2) and 2024 Event one (1) resulting in non-initial unsuccessful participation. The findings include: 1. Review of the CASPER-0155 report revealed the following unsatisfactory scores: 2023 Event 1: ABO/RHO = 0%, 2023 Event 2: ABO/RHO = 0%, 2024 Event 1: ABO /RHO = 80%. 2. A review of the laboratory's 2023 and 2024 API PT scores for the subspecialty ABO Group and D (RHO) typing confirmed the above findings resulting in non-initial unsuccessful participation for the Immunohematology subspecialty ABO Group and D (RHO) typing. -- 2 of 3 -- 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 (PT) desk review of the laboratory's Certification and Survey Provider Enhanced Reporting (CASPER)-0155 report and the American Proficiency Institute (API) 2023 (Events one, two and three), and 2024 (Event 1) result reports, the laboratory director failed to provide overall management and direction of 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 (PT) desk review of the laboratory's Certification and Survey Provider Enhanced Reporting (CASPER)-0155 report and American Proficiency Institute (API) 2023 (Events one, two and three), and 2024 (Event 1) result reports, the laboratory director failed to ensure the laboratory successfully participated in a proficiency testing program for the Immunohematology subspecialty ABO Group and D (RHO) typing and the analyte D (Rho) for three of four events. Refer to D2162 and D2163. -- 3 of 3 --

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at Whole Woman's Health Alexandria on January 17, 2024 by the Virginia Department of Health's Office of Licensure and Certification. The laboratory was surveyed under 42 CFR part 493 CLIA Regulations. The laboratory was not in compliance with the following 42 CFR part 493 CLIA CONDITION Regulations: D5400 - 42 C.F.R. 493-1250 Condition: Analytic Systems; D6000 - 42 C.F.R. 493-1403 Condition: Moderate Complexity, Laboratory Director, and D6063 - 42 C.F.R. 493-1421 Condition: Moderate Complexity, Testing Personnel. Specific deficiencies cited are as follows: D2015 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(5)(6) (5) The laboratory must document the handling, preparation, processing, examination, and each step in the testing and reporting of results for all proficiency testing samples. The laboratory must maintain a copy of all records, including a copy of the proficiency testing program report forms used by the laboratory to record proficiency testing results including the attestation statement provided by the PT program, signed by the analyst and the laboratory director, documenting that proficiency testing samples were tested in the same manner as patient specimens, for a minimum of two years from the date of the proficiency testing event. (6) PT is required for only the test system, assay, or examination used as the primary method for patient testing during the PT event. This STANDARD is not met as evidenced by: Based on a review of proficiency testing (PT) documentation, lack of documentation, and an interview, the laboratory failed to retain PT result reviews and attestation statements signed by the laboratory director (LD) and testing personnel (TP) for two (2) of five (5) Immunology/Immunohematology D (rho) events during the eighteen months reviewed from July 2022 until the date of the survey on January 17, 2024. The findings include: 1. Review of the laboratory's American Proficiency Institute (API) Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 6 -- PT documentation revealed no PT results and signed attestation statements for the following two events: 2022 API Immunology/Immunohematology-2nd Event-D (Rho) -a lack of result review or attestation signatures for LD and TP; 2022 API Immunology /Immunohematology-3rd Event-D (Rho)-a lack of result review or attestation signatures for LD and TP. The surveyor requested to review the PT results review and attestation documentation for the events listed above. The laboratory provided no documentation for review. 2. In an exit interview with the Interim Director and Clinic Manager on January 17, 2024, at approximately 12:00 PM, the above findings were confirmed. D5400 ANALYTIC SYSTEMS CFR(s): 493.1250 Each laboratory that performs nonwaived testing must meet the applicable analytic systems requirements in 493.1251 through 493.1283, unless HHS approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub.7), that provides equivalent quality testing. The laboratory must monitor and evaluate the overall quality of the analytic systems and correct identified problems as specified in 493.1289 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: Based on a laboratory tour, review of the laboratory's policies and procedures, quality control (QC) and quality assurance records, July 2022

Summary Statement of Deficiencies D0000 An unannounced, off-site CLIA proficiency testing (PT) desk review was conducted for Whole Woman's Health Alexandria on September 28, 2023 by the Virginia Department of Health's Office of Licensure and Certification. The laboratory was surveyed under 42 CFR part 493 CLIA Requirements. The laboratory was not in compliance with the following Conditions under 42 CFR part 493 CLIA Regulations: D2016 - 42 C.F.R. 493.803 Condition: Successful Participation, D6000 - 42 C.F.R. 493-1403 Condition: Moderate Complexity, Laboratory Director. Specific deficiencies cited are as follows. 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: 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 an off-site Proficiency Testing (PT) desk review of the laboratory's American Proficiency Institute (API) proficiency testing (PT) records for 2023, the CASPER 0153D Unsatisfactory and Unsuccessful PT Report and interview, the laboratory failed to participate in API D (Rho) proficiency testing for two (2) of 2 consecutive testing events in 2023 resulting in unsuccessful performance (Refer to D2162). D2162 ABO GROUP AND D(RHO) TYPING CFR(s): 493.859(f) Failure to achieve satisfactory performance for the same analyte 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 an off-site Proficiency Testing desk review of the laboratory's American Proficiency Institute (API) proficiency testing (PT) records, CASPER 0153D Unsatisfactory and Unsuccessful PT Report and interview, the laboratory failed to submit PT testing results to API within the specified time frame for D (Rho) Type testing in two (2) of 2 events for 2023 resulting in unsuccessful performance. The findings include: 1. Review of the laboratory's 2023 API Immunohematology PT records for Events 1 and 2 (a total of 2 events) revealed the laboratory failed to return results for API 2023 D (Rho) Type Events 1 and 2. The API report stated "0% Failure to Participate" for Events 1 and 2. 2. Review of the laboratory's CASPER Report 0153D revealed the following 2023 Rh events with results of less than 100%: 2023 Event 1 Rh = 0%, 2023 Event 2 Rh = 0%, resulting in unsuccessful performance. 3. In a telephone interview with the clinical manager on September 28, 2023, at approximately 9:35 AM, the findings were confirmed. The clinical manager stated they were informed by the testing personnel they received the wrong samples for testing and that they were going to contact API to order the correct ones. 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 review of the laboratory's

Summary Statement of Deficiencies D0000 An announced CLIA initial survey was conducted at Whole Woman's Health & Family Center on June 28, 2022 by the Virginia Department of Health's Office of Licensure and Certification. The laboratory was surveyed under 42 CFR part 493 CLIA Requirements. Specific deficiencies cited are as follows and include two (2) Conditions under 42 CFR part 493 CLIA Regulation: D5400 -42 CFR. 493.1250 Analytic Systems, D6063 -42 CFR. 493.1421 Condition Testing Personnel. D2159 ABO GROUP AND D(RHO) TYPING CFR(s): 493.859(d) Failure to return proficiency testing results to the proficiency testing program within the time frame specified by the program is unsatisfactory performance and results in a score of 0 for the testing event. This STANDARD is not met as evidenced by: Based on a review of the facility's Blood Bank Rh Factor proficiency testing (PT) documentation, and interviews, the laboratory failed to submit PT testing results to American Proficiency Testing Institute (API) for one (1) of 1 event reviewed for 2022. Findings include: 1. Review of the laboratory's API immunohematology PT documentation revealed that the laboratory failed to return their first enrolled event of calendar year 2022. API report stated "Test results were not received by American Proficiency Institute". The inspector inquired regarding the PT report outlined above. The office manager stated on 6/28/22 at approximately 2:00 PM, "We did not send the results in for grading. The staff did not refrigerate the samples and thought that they had set out too long before the error was noted." The inspector requested to review