Planned Parenthood

Summary Statement of Deficiencies D5449 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(ii)(g) (d)(3)(ii) Each qualitative procedure, include a negative and positive control material; This STANDARD is not met as evidenced by: Based on record review and interview, the laboratory did not perform a positive Rh (D) control test and a negative Rh (D) control test for each day of patient testing. Findings: 1. The laboratory was performing the Rh (D) antigen test using the Eldoncard RhD test cards. The laboratory used manufacturer's known positive and known negative Rh (D) quality control red cell reagents to check the reactivity of the Eldoncard RhD test cards. 2. During interview with laboratory staff on September 22, 2025 at 11:30 am it was confirmed that the laboratory performed the Rh (D) negative and Rh (D) positive quality control tests when a new package of test cards was opened, or with a change of test card lot numbers or with a change of testing person. The laboratory's written procedures did not include instructions to also test positive and a negative Rh (D)quality control (known positive and known negative Rh [D] red blood cells) reagents each day of patient testing. 3. The laboratory did not have documentation to show that on each day of patient testing the negative and positive Rh (D) red blood cell control reagents were tested. In the month of December 2024, the patient log showed that patient testing for Rh (D) was performed on December 2, 5, 9, 12, 17 and 19, 2024. December 5, 2024 was the only day that the Rh (D) positive and negative quality control reagents were tested. 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 D5787 TEST RECORDS CFR(s): 493.1283(a) The laboratory must maintain an information or record system that includes the following: (a)(1) The positive identification of the specimen. (a)(2) The date and time of specimen receipt into the laboratory. (a)(3) The condition and disposition of specimens that do not meet the laboratory's criteria for specimen acceptability. (a)(4) The records and dates of all specimen testing, including the identity of the personnel who performed the test(s). This STANDARD is not met as evidenced by: Based on review of patient Rh test records and interview with the technical consultant, the laboratory did not have policies to ensure Rh test results are documented on test records in a reliable manner. Findings: 1. On March 20, 2023, November 1, 2022 and October 19, 2022 a check mark was used to document that the patient control result was negative. 2. On April 10, 2023 the "c", that indicates where the control test result is entered was circled and a control result was not entered. 3. The laboratory's written procedure for documenting Rh test results did not state how to record Rh test results on the patient test result log. 4. This was confirmed with the technical consultant on the afternoon of the day of survey. 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 D6018 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(iii) 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)(iii) Ensure that all proficiency testing reports received are reviewed by the appropriate staff to evaluate the laboratory's performance and to identify any problems that require

Summary Statement of Deficiencies D2000 ENROLLMENT AND TESTING OF SAMPLES CFR(s): 493.801 Each laboratory must enroll in a proficiency testing (PT) program that meets the criteria in subpart I of this part and is approved by HHS. The laboratory must enroll in an approved program or programs for each of the specialties and subspecialties for which it seeks certification. The laboratory must test the samples in the same manner as patients' specimens. For laboratories subject to 42 CFR part 493 published on March 14, 1990 (55 FR 9538) prior to September 1, 1992, the rules of this subpart are effective on September 1, 1992. For all other laboratories, the rules of this subpart are effective January 1, 1994. This CONDITION is not met as evidenced by: Based on record review and interview with laboratory staff, the lab was not enrolled in proficiency testing for Rh testing for the first 2 proficiency test events of 2018. Findings: 1. The laboratory was not enrolled in proficiency testing through a proficiency test provider for the first and second events of 2018; 2. The CASPER report 0096D shows that the lab did not receive scores for event 1 and event 2 of 2018. The proficiency test provider was contacted and stated that the laboratory was not enrolled until the third event of 2018; 3. The laboratory obtained remedial proficiency testing that was evaluated by the provider on August 23, 2018, but did not participate in the regular first and second event cycles until the third event. D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. 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 -- This STANDARD is not met as evidenced by: Based on review of annual competency evaluations and interview with staff, the laboratory did not evaluate the technical consultant for technical consultant duties. Findings: 1. The competency check record used for the technical consultant was the same report used to document competency checks for testing personnel, but did not include additional duties performed as required of a technical consultant; and 2. This was confirmed during interview with lab staff on the day of survey. D5211 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(a) The laboratory must review and evaluate the results obtained on proficiency testing performed as specified in subpart H of this part. This STANDARD is not met as evidenced by: Based on record review and interview, the laboratory did not document the review of the proficiency test providers evaluation of the labs performance for the remedial proficiency testing event graded on August 23, 2018. Findings: 1. The laboratory obtained remedial proficiency testing for the Rh test after the lab missed enrollment in the first and second proficiency test events in 2018. The laboratory participated in the remedial event and the proficiency test provider graded the results and provided a performance report to the laboratory; 2. There was no written documentation that the remedial proficiency test results were reviewed by the lab director and staff, in addition there was no written