Virginia League For Planned Parenthood-Hampton

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at Virginia League for Planned Parenthood-Hampton on October 26, 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 deficiency cited is as follows: 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 five (5) events in the twenty-two (22) months reviewed (January 2021 to October 26, 2022). Findings include: 1. Review of the laboratory's 2021 and 2022 American Proficiency Institute (API) Hematology /Immunohematology PT documentation, a total of 5 events (2021 Events 1-3, 2022 Events 1-2), revealed no API signed attestation statement by the testing personnel for: API Hematology / Immunohematology 2022 Event 2. The inspector requested to review the attestation documentation for the PT event listed above. No documentation was available for review. 2. An exit interview with the COO and site manager on 10 /26/22 at approximately 12:00 PM 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 unannounced, off-site CLIA proficiency test desk review was conducted for Virginia League for Planned Parenthood on January 19, 2021 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 Proficiency Institute proficiency testing (PT) records and an interview, 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 of three ABO and RHo (D Group) testing events reviewed, resulting in unsuccessful PT performance (review: Events 1-3 of 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 an interview, the laboratory failed to attain satisfactory performance (a score of 100 percent acceptable responses) for immunohematology in two (2) of three (3) ABO/Rh Group (Anti-D Rh typing) Module testing events in calendar year 2020, resulting in unsuccessful PT performance. Findings include: 1. Review of the laboratory's American Proficiency Institute (API) PT results (2020 Events 1-3) revealed unsatisfactory scores for the following events: API 2020 Event 1: ABO/Rh Group = 80% and D (Rho) Typing = 80%, challenge specimens #RH-05 graded as incorrect, API report noted "results score is unacceptable"; API 2020 Event 3: ABO/Rh Group = 0% and D (Rho) Typing = 0%; API report noted "results not reported for five of five challenge samples resulting in score of zero"; resulting in an unsuccessful PT performance. 2. In a telephone interview with the chief operating manager on 1/19/21 at 10:00 AM, the above findings were confirmed. -- 2 of 2 --

Summary Statement of Deficiencies D0000 An announced on-site CLIA recertification survey was conducted at Virginia League for Planned Parenthood on November 10, 2020 by the Virginia Department of Health's Office of Licensure and Certification. The survey included an entrance interview on 11/4/2020 and virtual record review conducted on 11/5/2020. The laboratory was surveyed under 42 CFR part 493 CLIA Regulations. Specific deficiencies cited are as follows: D1001 CERTIFICATE OF WAIVER TESTS CFR(s): 493.15(e) Laboratories eligible for a certificate of waiver must-- (1) Follow manufacturers' instructions for performing the test; and (2) Meet the requirements in subpart B, Certificate of Waiver, of this part. This STANDARD is not met as evidenced by: Based on a tour, review of manufacturer's package insert, and an interview, the laboratory failed to follow manufacturer's instructions for two (2) of 2 urine pregnancy quality control (QC) vials stored in the laboratory refrigerator on November 10, 2020. Findings include: 1. During a laboratory tour on 11/10/20, at approximately 1:00 PM, the inspector noted 2 vials of HCG CON Rapid Response QC (Lot 190916, Level 1 Negative, Level 2 Positive) stored for use in the refrigerator. The vials had manufacturer's printed expiration date of March 16, 2020. The vials did not have an open or receive date recorded. The inspector inquired of the testing personnel regarding the protocols for using the observed QC materials. The testing personnel stated: "We use those QC for our urine pregnancy tests". The testing personnel directed the inspector to the facility's supply closet and pointed out one (1) box of corresponding waived HCG CON Rapid Response pregnancy test cassettes stored at room temperature. The test kit contained nine (9) of fifty (50) test cassettes (expiration date January 2021). 2. Review of the BTNX HCG CON Rapid Response QC package insert revealed manufacturer's instructions "Do not use beyond 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 -- printed expiration date". 3. In an exit interview with the facility staff at approximately 2:00 PM, the above findings were confirmed. 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 a review of 2019 and 2020 proficiency testing (PT) records and an interview, the laboratory failed to evaluate non-graded Vaginal Wet Preparation Potassium Hydroxide (KOH) PT results for one (1) of six (6) microscopy events reviewed. Findings include: 1. Review of the laboratory's American Proficiency Institute (API) microscopy PT documentation (2019 Events 1-3, 2020 Events 1-3) revealed no evaluation or verification of accuracy for Vaginal Wet Preparation KOH non-graded response for: 2019 Event 1: challenge sample VKP-01 -not graded due to non consensus. The inspector requested to review the facility's evaluation documentation for the non graded event challenge listed above. No additional documentation was available for review. 2. In an interview with the chief operating officer on 11/5/20, at approximately 4:00 PM, the above findings were confirmed. D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. 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), proficiency testing (PT) records, and an interview, the laboratory failed to verify the accuracy of Vaginal Wet Preparation Potassium Hydroxide (KOH) testing twice annually in calendar year 2020. Findings include: 1. Review of the laboratory's CMS 209 personnel form, during the entrance interview on 11/5/20, revealed that three (3) testing personnel perform patient Vaginal Wet Preparation (Prep) KOH microscopy examinations. 2. Review of the laboratory's American Proficiency Institute (API) microscopy PT documentation, a total of six (6) events, revealed the lab director utilized API PT to verify Vaginal Wet Prep KOH accuracy twice annually in 2019 and 2020. Review of the PT reports (2019 Events 1- 3, 2020 Events 1-3) revealed the laboratory received unsatisfactory Vaginal Wet Prep KOH results for the following two microscopy events: 2020 1st Event: 0%; failed for VKP-01; 2020 2nd Event: 0%; failed for VKP-02; resulting in API report statement: "unsuccessful long-term performance". 3. In an interview with the chief operating officer on 11/5/20, at approximately 4:00 PM, the above findings were confirmed. -- 2 of 2 --