Planned Parenthood South Atlantic

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at Planned Parenthood South Atlantic (Roanoke and Charlottesville) on December 19-20, 2024 by the Virginia Department of Health's Office of Licensure and Certification. The laboratory was surveyed under 42 CFR part 493 CLIA Regulations. Specific deficiency cited is as follows: D5203 SPECIMEN IDENTIFICATION AND INTEGRITY CFR(s): 493.1232 The laboratory must establish and follow written policies and procedures that ensure positive identification and optimum integrity of a patient's specimen from the time of collection or receipt of the specimen through completion of testing and reporting of results. This STANDARD is not met as evidenced by: Based on laboratory tours, review of the laboratory's policy manual, and interviews, the laboratory failed to follow their protocol for labeling patient samples with patient identifiers for two (2) of 2 urine samples observed in the first of two laboratory testing areas during the multiple site inspection on December 19, 2024. Findings include: 1. During a laboratory tour at physical location 2207 Peters Creek Road, Roanoke on 12 /19/25 at 1 PM, the inspector observed 2 patient urine samples in the testing processing area. The inspector noted sample #1 had no patient identifiers and sample #2 was labeled with initials and date 11/4/99. The inspector inquired of the testing personnel to describe the process of labeling patient samples collected for laboratory analysis. The testing personnel stated on 12/19/24 at 1:15 PM, "We are supposed to write initials and date of birth on all samples." 2. During the second laboratory tour for the multi-site survey on 12/20/24 at 11 AM at physical location 2964 Hydraulic Road Charlottesville, the inspector noted courier boxes and inquired regarding specimen labeling including those for send out tests. The lead testing personnel stated on 12/20/24 at 11 AM, "We write initials and date of birth on all samples and when 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 -- samples are reflexed to the reference laboratory we have requisitions that print out labels that we place on the samples before sending them out. We are to match up to the date of birth and initials that we write on all samples to insure correct sample is sent out". 3. Review of the multiple site laboratory policy manual revealed a procedure for labeling patient samples (titled: Reading and Recording Results) that stated "Label all patient samples with the following patient identifiers (initials, name, and medical record or date of birth). Before performing any test, each testing personnel must verify the patient identifiers on the sample and verify that they are correctly recording the result in the appropriate patient record." 4. An interview with the Director of Nursing and Operations Manager (Charlottesville) on 12/20/24 at 12: 30 PM confirmed the above findings. -- 2 of 2 --

Summary Statement of Deficiencies D0000 An announced CLIA Recertification survey was conducted at the Planned Parenthood South Atlantic on 03/06/23 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: 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 a review of proficiency testing (PT) records, the CASPER 0096D Application and Survey Summary Report, and an interview, the laboratory failed to attain an overall score of at least one hundred (100) percent (%) for the D(Rho) typing in one of three PT events in 2022. Findings include: 1. Review of the American Proficiency Institute (API) PT 2022 records (three events), and the CASPER 0096D Application and Survey Summary Report revealed the laboratory received an overall score of 80% for the third event in 2022 for the D(Rho) typing analyte. 2. An exit interview with the Facility Compliance Officer and Quality Manager on 03/06/22 at approximately 10:45 AM confirmed the 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 An announced CLIA Recertification virtual survey was conducted at the Planned Parenthood South Atlantic-Roanoke on May 4, 2021 by the Virginia Department of Health's Office of Licensure and Certification. The laboratory was surveyed under 42 CFR part 493 CLIA Requirements. The initial contact and entrance interview with laboratory conducted on April 19, 2021 with off-site record review of documentation on April 28, 2021. Specific deficiencies cited 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 (CLIA) (CMS-209 Form), and an interview, the laboratory failed to rotate PT among all testing personnel (TP) for five (5) of 6 events reviewed. Dates of record review include all 3 events in 2019 and 3 events in 2020. Findings include: 1. The review of the American Proficiency Institute (API) PT records revealed that testing personnel (TP) A performed all 3 events in 2019 and the first two events in 2020. (See attached personnel code list.) API Events 1-3 2019- TP A and API Events 1 and 2 2020- TP A. 2. Review of the CMS 209 laboratory personnel form revealed 4 TP performing patient testing in from January 1, 2019 and up to the date of survey on May 4, 2021. 3. An interview with the office manager and regional manager on May 4, 2021 at approximately 9:45 AM confirmed the 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 An announced CLIA Recertification survey was conducted at the Planned Parenthood South Atlantic on January 17, 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: D6030 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(12) 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)(12) Ensure that policies and procedures are established for monitoring individuals who conduct preanalytical, analytical, and postanalytical phases of testing to assure that they are competent and maintain their competency to process specimens, perform test procedures and report test results promptly and proficiently, and whenever necessary, identify needs for remedial training or continuing education to improve skills; This STANDARD is not met as evidenced by: Based on the review of the Laboratory Personnel Report Form (CLIA) (CMS-209 Form), policy and procedure (P&P), testing personnel (TP) records, and interview, the laboratory director failed to follow the established policy for competency assessments for three (3) of five (5) TP. Dates of record review are from January 1, 2017 and up to the date of survey on January 17, 2019. Findings include: 1. Review of CLIA CMS- 209 form revealed that there were 5 TP. TP E was a new TP in September 2018. (See attached TP Code Sheet). 2. Review of the P&P "Quality Control and Assessment Program - Internal Training and Competency Testing" revealed the following statements: "The laboratory director or designee provides training of Rh testing and provider performed microcopy, which is overseen by laboratory/medical director. The 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 -- laboratory director or the technical consultant assesses and signs off on the competency of testing personnel providing moderate complexity tests (Rh typing). Documentation of initial, six month and subsequent competencies on internal procedures is maintained in the "CLIA" binders at each health center." 3. Review of TP records and an interview with the director of nursing at approximately 11:30 AM revealed the following: TP A- no documentation of review by the laboratory director for the 2017 competency assessment. No documentation of an annual competency assessment for the calendar year 2018. TP C-No documentation of an annual competency assessment for the calendar year 2018. TP E- No documentation of initial training and competency assessment in September 2018. 4. An interview with the nursing director at approximately 12:30 PM confirmed the above-listed findings. -- 2 of 2 --