Va League For Planned Parenthood Virginia Beach

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at VA League for Planned Parenthood Virginia Beach on May 21, 2024 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 Conditions under 42 CFR part 493 CLIA Regulation: D6000 -42 CFR. 493.1403 Laboratory Director D6063 -42 CFR. 493.1421 Condition Testing Personnel D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) 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 a review of proficiency testing (PT) records, lack of documentation, and an interview, the laboratory failed to retain their PT attestation statements signed by the lab director (LD) and testing personnel (TP) for two (2) of three (3) microscopy events in calendar year 2023. **REPEAT DEFICIENCY Findings include: 1. Review of the laboratory's 2023 American Proficiency Institute (API) Microscopy Vaginal Wet Prep PT documentation, a total of 3 (Events 1-3), revealed no signed attestation statement for: API Microscopy 2023 Event 1 - no TP signed attestation, no LD signed attestation; API Microscopy 2023 Event 2 - no LD signed attestation. The inspector requested to review the attestation documentation for microscopy events outlined above. No records were available for review. 2. An exit interview with the facility's Compliance Manager on 5/21/24 at 3:30 PM confirmed the above findings. D5449 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(ii)(g) 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 -- Unless CMS Approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing, the laboratory must-- At least once a day patient specimens are assayed or examined perform the following for-- Each qualitative procedure, include a negative and positive control material; (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on a review of the facility's laboratory test logs, policies, lack of documentation, and an interview, the laboratory failed to document quality control (QC) for Anti-D Rh tests on two (2) of sixty-nine (69) days of patient testing in a randomly selected seven months of review during the inspection on 5/21/24 (review timeframe: January to March 2023, and February to April 2023). Findings include: 1. Review of Eldoncard Rhesus Factor - Anti-D Rh laboratory test logs for two randomly selected timeframes (January to March 2023, and February to April 2024) revealed the following 2 dates with no QC documentation and number of patients tested: 1/10/23- 2 patients Medical Record Numbers (MRN) 99385, 143272; 2/14/24 - 1 patient MRN 3611401. A total of 2 days with no QC documentation while reporting three patient Anti-D Rh results. The inspector requested to review the QC documentation on the dates of patient testing outlined above. No documentation was available for review. 2. Review of the laboratory's QA policies revealed a QC protocol that stated "Rh controls are to be documented daily before any client sample testing is done." 3. An exit interview with the facility's Compliance Manager on 5/21/24 at 3:30 PM confirmed the above findings. 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 proficiency testing (PT) records, Centers for Medicare and Medicaid Services Laboratory Personnel Report form, personnel records, policies, lack of documentation, and interviews, the laboratory director (LD) failed to ensure: 1. the results for one of three Microscopy PT events were submitted within the reporting timeframe deadline in calendar year 2023 (a repeat deficiency), Cross Reference D6017; 2. retention of education documentation for one of four testing personnel responsible for immunohematology RhD antigen testing during the review timeframe of April 2022 to the date of the inspection on May 21, 2024 (a repeat deficiency), Cross reference D6029. D6017 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(ii) 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)(ii) Ensure that results are returned within the timeframes established by the proficiency testing program. -- 2 of 4 -- This STANDARD is not met as evidenced by: Based on a review of proficiency testing (PT) records, lack of documentation, and interviews, the laboratory director (LD) failed to ensure that the results for one (1) of three (3) Microscopy PT events were submitted within the reporting timeframe deadline in calendar year 2023. **REPEAT DEFICIENCY Findings include: 1. Review of the laboratory's 2023 American Proficiency Institute's (API) Microscopy PT records (Events 1-3) revealed: API 2023 Microscopy Event 1 for Vaginal Wet Prep scored zero due to failure to participate. The inspector inquired regarding the laboratory's protocol for returning PT results within API guidelines. The Compliance Manager stated at approximately 3:00 PM: "We do have a protocol in place to submit for review and then to submit final results to API. I was not here in this role at that time and according to the staff, the previous manager failed to submit the results." 2. An exit interview with the facility's Compliance Manager on 5/21/24 at 3:30 PM confirmed the above findings. D6029 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(11) 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)(11) Ensure that prior to testing patients' specimens, all personnel have the appropriate education and experience, receive the appropriate training for the type and complexity of the services offered, and have demonstrated that they can perform all testing operations reliably to provide and report accurate results. 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), testing personnel (TP) records, policies, and an interview, the laboratory director (LD) failed to ensure retention of education documentation for for one of four testing personnel from June 29, 2022 to the date of the inspection on May 21, 2024. (See Personnel Code Sheet.) **REPEAT DEFICIENCY Findings include: 1. Review of the CMS 209 Laboratory Personnel Report revealed that the LD identified four TP listed as qualified to perform moderate complexity RhD antigen patient immunohematology testing during the twenty-five month inspection timeframe (April 2022 to 5/21/24). 2. Review of the available laboratory personnel records revealed that TP A's initial training record was dated 6/29 /22. The inspector noted that TP A's file lacked a record of education. The inspector requested to review documentation of education qualifications for TP A. No record was available for review. 3. Review of laboratory policy "2022 CMS Statement of Deficiencies

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at Virginia League for Planned Parenthood on April 13, 2022 by the Virginia Department of Health's Office of Licensure and Certification. The inspector noted that the laboratory performs SARS-CoV-2 (COVID-19) testing and is in compliance with the applicable COVID- 19 reporting requirements. The laboratory was surveyed under 42 CFR part 493 CLIA Requirements. Specific deficiencies cited are as follows and includes the laboratory was not in compliance with: D6063-42 C.F.R. 493.1421 Condition: Testing Personnel. D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) 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 a review of proficiency testing (PT) records, lack of documentation, and an interview, the laboratory failed to retain their PT attestation statements signed by the testing personnel for one (1) of six (6) immunohematology events in the twenty-six (26) months reviewed (January 2020 to April 13, 2022). Findings include: 1. Review of the laboratory's 2020 and 2021 American Proficiency Institute (API) Immunohematology PT documentation, a total of 6 events (2020 Events 1-3, 2021 Events 1-3), revealed no API signed attestation statement by the testing personnel for: API Immunohematology 2021 Event 3. The inspector requested to review the attestation documentation for the D (Rho) event listed above. No documentation was available for review. 2. An exit interview with the COO on 4/13/22 at approximately 2:00 PM confirmed the findings. D6017 LABORATORY DIRECTOR RESPONSIBILITIES 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 -- CFR(s): 493.1407(e)(4)(ii) 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)(ii) Ensure that results are returned within the timeframes established by the proficiency testing program. This STANDARD is not met as evidenced by: Based on a review of the Clinical Laboratory Improvement Amendments Application for Certification form (CLIA 116), proficiency testing (PT) records, lack of documentation, and interviews, the laboratory director (LD) failed to ensure that the results for one (1) of seven (7) hematology/coagulation PT events were submitted within the reporting timeframe deadline as reviewed on the date of the inspection, April 13, 2022. Findings include: 1. Review of the laboratory's CLIA 116 form revealed that the LD verified moderate complexity patient vaginal wet mount- potassium hydroxide (KOH) microscopy testing during the survey timeframe (January 2020 to April 2022). 2. Review of the laboratory's KOH microscopy American Proficiency Institute's (API) PT records (a total of 7 events: 2020 Event 1-3, 2021 Event 1-3, 2022 Event 1) revealed no evidence of submitting results for: 2022 Hematology /Coagulation Module- 1st Event: Vaginal Wet Prep challenge VKP-01 and VA-01 The inspector noted an API program form for the event outlined above that stated "these test results have not been submitted" and inquired regarding the laboratory's protocol for returning PT results within API guidelines. The Chief Operating Officer (COO) stated at approximately 1:30 PM: "We do have a protocol in place to submit for review and then to submit final results to API". 3. The inspector requested to review the transmission of results for the event outlined above. The COO called API technical support to request records on 4/13/22 at approximately 1:40 PM. The technical support representative confirmed that PT results were not received by the deadline of March 30, 2022. 4. An exit interview with the COO on 4/13/22 at approximately 2:00 PM confirmed the findings D6029 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(11) 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)(11) Ensure that prior to testing patients' specimens, all personnel have the appropriate education and experience, receive the appropriate training for the type and complexity of the services offered, and have demonstrated that they can perform all testing operations reliably to provide and report accurate results. 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), testing personnel (TP) records, and an interview, the laboratory director (LD) failed to document the review/approval of the initial training and competency assessment for TP A in calendar year 2020. (See Personnel Code Sheet.) Findings include: 1. Review of the CMS 209 form revealed that the LD -- 2 of 4 -- identified seventeen new testing personnel that included TP A as responsible for moderate complexity patient immunohematology D (Rho) blood typing during the review timeframe period (January 2020 to April 2022). 2. Review of TP records revealed no evidence of the LD's review/approval of the training and competency assessment for TP A. The inspector inquired regarding the lack of documentation. The Chief Operating Officer (COO) stated: "We do not have the LD's signature or a designee's signature for the training. It is our protocol to do so, but I do not have the record for you." 3. An exit interview with the COO on 4/13/22 at approximately 2:00 PM confirmed the findings. 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 the Centers for Medicare and Medicaid Services Laboratory Personnel Report form (CMS 209), laboratory personnel files, procedures, lack of documentation, and an interview, the technical consultant (TC) failed to document the 2020 annual immunohematology D (Rho) blood typing competency evaluation for one (1) of fifteen (15) randomly selected testing personnel (TP) files reviewed on 4/13 /22. Findings include: 1. Review of the CMS 209 personnel form revealed that the laboratory director (LD) also performed the duties of TC and indicated twenty-nine (29) TP who performed moderate complexity testing during the twenty-six (26) months reviewed (January 2020 to 4/14/22). 2. Review of 15 randomly selected TP files revealed that TP B's file lacked a 2020 annual immunohematology D (Rho) competency evaluation. (See Personnel Code Sheet.) The inspector requested to review the 2020 competency assessment for TP B. No documentation was available for review. 3. Review of the laboratory procedures revealed protocols that outlined annual competency assessments to be completed annually by the LD or the LD's designee for all testing personnel. 4. An exit interview with the COO on 4/13/22 at approximately 2:00 PM confirmed the findings. 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, available testing personnel records, lack of documentation, and an interview, the laboratory failed to retain documentation of personnel qualifications for one of seventeen new testing personnel responsible for reporting non waived immunohematology D (Rho) blood typing during the timeframe of August 2020 to the date of the survey on April 13, 2022. See D6065. D6065 TESTING PERSONNEL QUALIFICATIONS -- 3 of 4 -- 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), available testing personnel records, lack of documentation, and an interview, the laboratory failed to retain documentation of personnel qualifications for TP C responsible for reporting non waived immunohematology D (Rho) blood typing from August 2020 to the date of the survey on April 13, 2022. (See Personnel Code Sheet.) Findings include: 1. Review of the CMS 209 form revealed that the lab director identified seventeen new testing personnel that included TP C as responsible for patient immunohematology D (Rho) during the review timeframe period (January 2020 to April 2022). 2. Review of the available personnel documents for TP C revealed no education record (diploma or official transcript). Review of the laboratory personnel training records revealed that TP C's initial training and sign off for patient testing was verified/signed by the technical consultant on 8/18/20. The inspector requested to review education record for TP C. No record was retained/available for review. 3. An exit interview with the Chief Operating Officer on 4/13/22 at approximately 2:00 PM confirmed the findings. -- 4 of 4 --

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at Virginia League for Planned Parenthood on December 19, 2019 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: 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) records, lack of documentation, and an interview, the laboratory failed to retain their PT report form records and attestation statements signed by the laboratory director (LD) and testing personnel for one (1) of six (6) immunohematology events in the twenty-one (21) months reviewed. Findings include: 1. Review of the laboratory's 2018 and 2019 American Proficiency Institute (API) PT documentation, a total of 6 events, revealed no API report form or signed attestation statements (by LD and testing personnel) for 2019 Event 3. The inspector requested to review the attestation documentation and API result report forms for the D (Rho) event listed above. No documentation was available for review. The quality risk management coordinator stated, at approximately 12:30 PM, "I have looked 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 -- the forms and cannot locate them at this time. The testing staff have misplaced them" 2. An exit interview with the quality risk management coordinator at 2:30 PM confirmed the findings. D5407 PROCEDURE MANUAL CFR(s): 493.1251(d) Procedures and changes in procedures must be approved, signed, and dated by the current laboratory director before use. This STANDARD is not met as evidenced by: Based on review of the Centers for Medicare and Medicaid Services Laboratory Personnel Report form (CMS 209), policy and procedure manual, lack of documentation, and interviews, the laboratory director (LD) failed to document approval (signature) of the laboratory's procedures from August 2019 to the date of the survey on December 19, 2019. Findings include: 1. An interview and review of the CMS 209 personnel form with the quality risk management coordinator, at approximately 11:30 AM, revealed that a LD change occurred in August 2019. 2. Review of the laboratory's policy and procedure manual revealed no signature or date documentation that the new LD reviewed/approved the procedures. The inspector made an inquiry for record of the current LD's approval of the laboratory procedures. No documentation was available for review. The quality risk management coordinator stated, at approximately 1:30 PM, "I do not have documentation of review for this facility. [He/She] did review the policies at one of our other centers. I will get with the director as soon as possible to get the signature for this location". 3. An exit interview with the quality risk management coordinator at 2:30 PM confirmed the findings. 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 the 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 document the 2018 annual immunohematology D (Rho) competency evaluation for one (1) of fifteen (15) testing personnel. Findings include: 1. Review of the CMS 209 personnel form revealed that the laboratory director (LD) also performed the duties of TC and indicated twenty- eight (28) testing personnel (TP) who performed moderate complexity testing during the twenty-four (24) months reviewed. 2. Review of 15 randomly selected TP files revealed that TP A's file lacked a 2018 annual immunohematology D (Rho) competency evaluation. (See Personnel Code Sheet.) The inspector requested to review the 2018 competency assessment for TP A. No documentation was available for review. 3. An exit interview with the quality risk management coordinator at 2:30 PM confirmed the findings. -- 2 of 2 --

Summary Statement of Deficiencies D0000 An announced CLIA Recertification survey was conducted at the Virginia League for Planned Parenthood on March 21, 2018 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: D6029 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(11) 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)(11) Ensure that prior to testing patients' specimens, all personnel have the appropriate education and experience, receive the appropriate training for the type and complexity of the services offered, and have demonstrated that they can perform all testing operations reliably to provide and report accurate results. This STANDARD is not met as evidenced by: Based on the review of the Laboratory Personnel Report (CLIA) (Form CMS-209), testing personnel (TP) records, and interviews, the laboratory director failed to document the review and approval of the initial training and competency assessments for five (5) of the five (5) new TP in 2017. Findings include: 1. Review of the CMS 209 Form and personnel records revealed that there were 5 new TP that had training and initial competency assessment documentation in 2017. Review of the TP initial competency assessment records revealed no evidence of the laboratory director's review and approval of the training and competency assessments. (See attached Personnel Code list.) 2. An interview with the Chief Quality Officer and Human Resource manager at approximately 11: 00 AM confirmed that the laboratory director did not document the review and approval of the initial training and competency assessments for the 5 new TP in 2017. 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 --