Virginia Womens Wellness

Summary Statement of Deficiencies D0000 An unannounced, off-site, CLIA proficiency test desk review was conducted for Professional Medical Services, PC (DBA Virginia Women's Wellness Center) on November 27, 2023 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 the Condition under 42 CFR part 493 CLIA Regulation: D2016 -42 CFR. 493.803 Successful Participation. 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 2 -- Based on an off-site desk review of the laboratory's proficiency testing (PT) records and interviews, the laboratory failed to attain satisfactory performance (a score of 100 percent acceptable responses) for immunohematology in two consecutive ABO/RHo (D Group) module testing events reviewed, resulting in unsuccessful PT performance (review: second and third events of calendar year 2023). See 2163. 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 an off-site desk review of proficiency testing (PT) records and interviews, the laboratory failed to attain satisfactory performance (a score of 100 percent acceptable responses) for immunohematology in two (2) consecutive ABO/Rh Group (Anti-D Rh typing) testing events in calendar year 2023, resulting in unsuccessful PT performance. Findings include: 1. Review of the laboratory's American Association of Bioanalysts (AAB)/Medical Laboratory Evaluation (MLE) Nonchemistry ABO/RHo (D) Group PT Modules revealed unsatisfactory scores for the following 2 consecutive events: AAB/MLE 2023 Event 2: ABO/D (Rho) Typing = 80%; challenge specimen #6 graded as incorrect, AAB report noted "result score is below CMS limit"; AAB /MLE 2023 Event 3: ABO/D (Rho) Typing = 0%; AAB report noted "results not reported to AAB for five of five challenge samples resulting in score of zero"; resulting in an unsuccessful PT performance. 2. Interviews with AAB/MLE technical support specialist on 11/27/23 at approximately 9:30 AM, laboratory business' human resource manager at 10:00 AM, laboratory's office/nurse manager at 11:00 AM and 1: 30 PM, confirmed the above findings. -- 2 of 2 --

Summary Statement of Deficiencies D0000 An announced on-site CLIA recertification survey was conducted at Professional Medical Services, PC on August 11, 2022 by the Virginia Department of Health's Office of Licensure and Certification. The laboratory was surveyed under 42 CFR part 493 CLIA Regulations. Specific deficiencies cited are as follows and include the following Condition under 42 CFR part 493 CLIA Regulation: D6063 -42 CFR. 493.1421 Condition Testing Personnel. D6054 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 annually, after the first year. This STANDARD is not met as evidenced by: Based on a review of Centers for Medicare and Medicaid Services Laboratory Personnel Report form (CMS 209), laboratory personnel files, lack of documentation, and an interview, the technical consultant (TC) failed to perform annual ABO/Rh Group Anti-D Rh typing competency evaluations for one of six testing personnel (TP) in calendar year 2021. Findings include: 1. Review of the CMS 209 form revealed that the laboratory director (LD) also performs the duties of TC. The LD identified six TP responsible for non waived ABO/Rh Group Anti-D Rh typing during the 21 months of review (timeframe: November 2020 to the date of the survey on August 11, 2022). 2. Review of the laboratory personnel files revealed that TP A lacked a 2021 annual Anti-D Rh typing competency assessment. The inspector requested to review the competency assessment documentation. No record was available for review. (See Personnel Code Sheet.) 3. An exit interview with the office manager on 8/11/22 at approximately 2 PM 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 2 -- D6063 LABORATORY TESTING PERSONNEL CFR(s): 493.1421 The laboratory must have a sufficient number of individuals who meet the qualification requirements of 493.1423, to perform the functions specified in 493. 1425 for the volume and complexity of tests performed. This CONDITION is not met as evidenced by: Based on a review of the Centers for Medicare and Medicaid Services Laboratory Personnel Report form, testing personnel records, and an interview, the laboratory failed to retain documentation of education qualifications for one of six testing personnel responsible for reporting moderate complexity ABO/Rh Group Anti-D Rh typing test results during the timeframe of January 2022 to the date of the inspection on August 11, 2022. See D6065. D6065 TESTING PERSONNEL QUALIFICATIONS CFR(s): 493.1423(b)(1)(2)(3)(4)(i) (b) Meet one of the following requirements: (b)(1) Be a doctor of medicine or doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located or have earned a doctoral, master's, or bachelor's degree in a chemical, physical, biological or clinical laboratory science, or medical technology from an accredited institution; or (b)(2) Have earned an associate degree in a chemical, physical or biological science or medical laboratory technology from an accredited institution; or (b)(3) Be a high school graduate or equivalent and have successfully completed an official military medical laboratory procedures course of at least 50 weeks duration and have held the military enlisted occupational specialty of Medical Laboratory Specialist (Laboratory Technician); or (b)(4)(i) Have earned a high school diploma or equivalent; and This STANDARD is not met as evidenced by: Based on a review of the Centers for Medicare and Medicaid Services Laboratory Personnel Report form (CMS 209), personnel records, lack of documentation, and interviews, the laboratory director (LD) failed to retain documentation of education qualifications for one of six testing personnel (TP) from January 2022 to the date of the inspection, on August 11, 2022. Findings include: 1. Review of the CMS 209 Laboratory Personnel Report revealed that the LD identified six TP as qualified to perform moderate complexity Anti-D Rh patient immunohematology typing. 2. Review of the available laboratory personnel records of TP B for evaluation of education documentation revealed no record. TP B's personnel record indicated initial training and patient Anti-D Rh testing began January 2022. 3. The inspector requested to review education documentation for TP B. The records were not available for review. The office manger stated at approximately 1 PM, "I asked for the education records from our main office and from the employee repeatedly but have not received them to date." 4. An exit interview with the office manager on 8/11/22 at approximately 2 PM confirmed the above findings -- 2 of 2 --

Summary Statement of Deficiencies D0000 An announced on-site CLIA recertification survey was conducted at Professional Medical Services, PC on October 27, 2020 by the Virginia Department of Health's Office of Licensure and Certification. The laboratory was surveyed under 42 CFR part 493 CLIA Regulations. The survey included an entrance interview on 10/14/2020 and virtual record review conducted on 10/26/2020. The laboratory was not in compliance with the following Condition under 42 CFR part 493 CLIA Regulations: D6000 - 42 CFR. 493.1403 Condition: Moderate complexity laboratory director. 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 the laboratory's 2019 and 2020 immunohematology proficiency testing (PT) records, and an interview, the laboratory failed to retain attestation statements signed by the laboratory director (LD) and testing personnel (TP) for three (3) of six (6) events reviewed. *REPEAT DEFICIENCY 1. Review of the laboratory's American Association of Bioanalysts (AAB) immunohematology PT records, a total of six (6) events for ABO/Rh Group (Anti-D Rh typing), revealed no LD or TP signed 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 -- attestation statements for: 2019 Event 2, 2019 Event 3, 2020 Event 3. The inspector requested to review the LD and TP attestation documentation for the PT events listed above. No documentation was available for review. 2. In an interview with the lead testing personnel, on 10/27/20 at approximately 2:30 PM, the above findings were confirmed. 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 review of the laboratory's policy and procedure manual, 2019 and 2020 immunohematology proficiency testing (PT) documentation, and an interview, the laboratory director failed to ensure that the quality assurance (QA) policies for PT attestations by testing personnel and director were maintained during the twenty-four (24) months reviewed. See D6021. 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's policy and procedure manual, 2019 and 2020 immunohematology proficiency testing (PT) records, lack of documentation, and an interview, the laboratory director (LD) failed to ensure that the quality assurance (QA) policies were maintained during the twenty-four (24) months reviewed. Findings include: 1. Review of the laboratory's policy and procedure manual revealed a written and approved QA policy ("Quality Assessment Procedures") that included protocols that the LD would oversee the proficiency testing program to include testing personnel (TP) rotation and signed attestations by LD and TP. 2. Review of the laboratory's American Association of Bioanalysts (AAB) immunohematology PT records, a total of six (6) events for ABO/Rh Group (Anti-D Rh typing), revealed no LD and TP signed attestation statements for: 2019 Event 2, 2019 Event 3, 2020 Event 3. The inspector requested to review the attestations. No records were available for review. The inspector requested to review QA

Summary Statement of Deficiencies D0000 An unannounced, off-site CLIA proficiency test desk review was conducted for Professional Medical Services, PC on August 10, 2020 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: 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 an off-site desk review of the laboratory's American Association of Bioanalysts proficiency testing (PT) records and interviews, the laboratory failed to attain satisfactory performance (a score of 100 percent acceptable responses) for 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 -- immunohematology in two consecutive ABO and RHo (D Group) module testing events reviewed, resulting in unsuccessful PT performance (review: first and second events of calendar year 2020). See 2163. 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 an off-site desk review of proficiency testing (PT) records, and interviews, the laboratory failed to attain satisfactory performance (a score of 100 percent acceptable responses) for immunohematology in two (2) consecutive ABO/Rh Group (Anti-D Rh typing) testing events in calendar year 2020, resulting in unsuccessful PT performance. Findings include: 1. Review of the laboratory's American Association of Bioanalysts (AAB) ABO and RHo (D) Groups PT Modules revealed unsatisfactory scores for the following consecutive events: AAB 2020 Event 1: ABO/Rh Group = 0 % and D (Rho) Typing = 0%; AAB report noted "results not reported to AAB for five of five challenge samples resulting in score of zero"; AAB 2020 Event 2: ABO/Rh Group = 60% and D (Rho) Typing = 60%, challenge specimens #9 and #10 graded as incorrect, AAB report noted "results score is below CMS limit"; resulting in an unsuccessful PT performance. 2. In telephone interviews with AAB technical support specialist on 8/10/20 at approximately 11:30 AM, practice's office manager and nurse manager on 8/12/20 at 1:00 and 3:00 PM, the above findings were confirmed. -- 2 of 2 --

Summary Statement of Deficiencies D0000 An announced CLIA Recertification survey was conducted at Professional Medical Services, PC on June 5, 2018 by the Virginia Department of Health's Office of Licensure and Certification. The laboratory was surveyed under 42 CFR part 493 CLIA Requirements. Deficiencies are as follows: 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 proficiency testing (PT) records, Laboratory Personnel Report form (CMS 209), and an interview, the laboratory failed to rotate proficiency testing among the three (3) testing personnel for three (3) of the six (6) events reviewed. Findings include: 1. The review of the American Association of Bioanalysts (AAB) PT records revealed that the testing personnel (TP) A performed 3rd event in 2016 and the 1st and 2nd events in 2017. (See attached personnel code list.) 2. Review of the CMS 209 laboratory personnel form revealed three (3) testing personnel performing testing in 2016 and up to the date of survey on June 5, 2018. 3. An interview with the primary testing personnel at approximately 4:00 PM confirmed that the laboratory failed to rotate the AAB PT events among all testing personnel for the events specified above. D2015 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(5)(6) (5) The laboratory must document the handling, preparation, processing, examination, 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 -- 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 review of proficiency testing (PT) records and an interview, the laboratory failed to maintain the attestation statement and submitted results for the 3rd event in 2017. Findings include: 1. Review of the American Association of Bioanalysts (AAB) PT records revealed that the laboratory did not have documentation of the attestation statement and submitted results for the 3rd event in 2017. 2. An interview the primary testing personnel at approximately 4:00 PM confirmed that the laboratory failed to maintain the documents specified above for the 3rd event in 2017. D2154 ABO GROUP AND D(RHO) TYPING CFR(s): 493.859(b) Failure to attain an overall testing event score of at least 100 percent is unsatisfactory performance. This STANDARD is not met as evidenced by: Based on the review of proficiency testing (PT) records and an interview, the laboratory failed to achieve satisfactory performance, a score of 100%, in the specialty of Immunohematology (Anti-D Rh typing) for the 3rd event in 2016. Findings include: 1. Review of the American Association of Bioanalysts (AAB) PT records revealed that the laboratory received a score of 80% for the 3rd event in 2016 for the Anti-D Rh typing. 2. An interview the primary testing personnel at approximately 4: 00 PM confirmed that the laboratory did not receive a satisfactory score of 100% in the specialty of Immunohematology for the 3rd event in 2016. D2160 ABO GROUP AND D(RHO) TYPING CFR(s): 493.859(e) (1) For any unsatisfactory testing event for reasons other than a failure to participate, the laboratory must undertake appropriate training and employ the technical assistance necessary to correct problems associated with a proficiency testing failure. (2) For any unacceptable analyte or unsatisfactory testing event score, remedial action must be taken and documented, and the documentation must be maintained by the laboratory for two years from the date of participation in the proficiency testing event. This STANDARD is not met as evidenced by: Based on the review of proficiency testing (PT) records for the specialty of Immunohematology (Anti-D Rh typing) and an interview, the laboratory failed to have documentation of remedial actions for the unsatisfactory score of 80% for the 3rd event in 2016. Findings include: 1. Review of the American Association of -- 2 of 3 -- Bioanalysts (AAB) PT revealed that the laboratory received a score of 80% for the 3rd event in 2016. There was no documentation of remedial actions performed for the unsatisfactory event. 2. An interview the primary testing personnel at approximately 4: 00 PM confirmed that the laboratory did not perform and document remedial actions for the above-specified event. -- 3 of 3 --