Planned Parenthood Of Southwest & Central

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at PLANNED PARENTHOOD OF SOUTHWEST CENTRAL from 06/25/2025 to 06/30/2025. The laboratory was not in compliance with 42 CFR Part 493, Requirements for Laboratories. The following is a description of the standard level deficiencies: D2007 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) (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 record review and staff interview, the laboratory failed to have one out of four testing personnel (TP) rotate through the testing of Proficiency Testing (PT) for Chemistry specialty in 2 out of 2 years reviewed. Findings included: 1-Review of FORM CMS-209 signed and dated by the Laboratory Director (LD) on 06/13/2025 revealed the laboratory had five TP listed (TP#1, TP#2, TP#3, TP#4 and TP#5), of these four TP participated in the Chemistry specialty testing (TP#1, TP#2, TP#3 and TP#4) for the i-stat Total Beta-Human Chorionic Gonadotropin (B-hCG) test. 2- Review of personnel records for TP#4, revealed that she had competencies evaluation on 2023, 2024 and 2025. 3-Review of American Proficiency Institute (API) PT records for 2023 (third event), 2024 (first, second and third event) and 2025 (1st and second event) in the specialty of Chemistry, revealed that TP#4 had no PT participation. During an interview on 06/25/2025 at 12:30 PM, with TP#4 she confirmed that she failed to participate in PT during this period. D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) 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 -- (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 record review and staff interview, the Laboratory Director (LD) failed to sign attestation for Proficiency Testing (PT) for Chemistry for the 1st event of 2024. Findings included: 1-Review of FORM CMS-209 signed and dated by the Laboratory Director (LD) on 06/13/2025, revealed that she was the LD, Clinical Consultant (CC) and Technical Consultant (TC). 2-Review of the Procedure Manual signed by the LD in February 2025, revealed that there was no designee to sign the PT attestations. 3- Review of American Proficiency Institute (API) Proficiency Testing (PT) records for first event of 2024, revealed that the LD failed to sign attestation for the Chemistry specialty for the i-stat Total Beta-Human Chorionic Gonadotropin (B-hCG). During an interview on 06/25/2025 at 12:00 PM, Testing Personnel #4 confirmed that the LD failed to sign attestation for the events of reference, she explained that the Chief Medical Officer signed at that time, no delegation of duties letter found for the Doctor of reference. -- 2 of 2 --

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at Planned Parenthood of Southwest and Central Florida Inc on 07/19/23. The laboratory is not in compliance with 42 CFR Part 493, Requirements for Laboratories. The following is a description of the standard level deficiencies: D5439 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(b) Unless otherwise specified in this subpart, for each applicable test system the laboratory must do the following: Perform and document calibration verification procedure - (b)(1) Following the manufacturer's calibration verification instructions; (b)(2) Using the criteria verified or established by the laboratory under 493.1253(b)(3) -- (b)(2)(i) Including the number, type, and concentration of the materials, as well as acceptable limits for calibration verification; and (b)(2)(ii) Including at least a minimal (or zero) value, a mid-point value, and a maximum value near the upper limit of the range to verify the laboratory's reportable range of test results for the test system; and (b)(3) At least once every 6 months and whenever any of the following occur: (b)(3)(i) A complete change of reagents for a procedure is introduced, unless the laboratory can demonstrate that changing reagent lot numbers does not affect the range used to report patient test results, and control values are not adversely affected by reagent lot number changes. (b)(3)(ii) There is major preventive maintenance or replacement of critical parts that may influence test performance. (b)(3)(iii) Control materials reflect an unusual trend or shift, or are outside of the laboratory's acceptable limits, and other means of assessing and correcting unacceptable control values fail to identify and correct the problem. (b)(3)(iv) The laboratory's established schedule for verifying the reportable range for patient test results requires more frequent calibration verification. This STANDARD is not met as evidenced by: Based on review of calibration verification records and interview, the laboratory failed 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 -- to perform calibration verification every 6 months on the Abbott iStat analyzer from 06/23/2021 to 07/19/2023. Findings Included: Review of calibration verification records for the Abbott iStat revealed the calibration verification for beta - human chorionic gonaodtropin hormone (bHCG) had been performed 01/ 05/2022 and 06/17 /22 since the last survey conducted on 06/23/2021 to the date of the current survey (07 /19/2023). Record review of the laboratory's Individualized Quality Control Plan signed and dated by the laboratory director on 3/30/23, revealed "I-Stat does not alert when calibration verification is due since it is factory calibrated, updated software is released every 6 months, all analyzers must be updoated or they will cease to function,. Following an update, it is recommended performing liquid calibration verfication, three levels". On 07/19/23 at 03:20 PM, the Senior Health Center Manager stated Testing Personnel #A confirmed that the every 6 months calibration verification procedure had not been performed on the analyzer in 2023. -- 2 of 2 --

Summary Statement of Deficiencies D2010 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(2) The laboratory must test samples the same number of times that it routinely tests patient samples. This STANDARD is not met as evidenced by: Based on record review and interview with laboratory personnel, the laboratory did not test proficiency testing samples the same number of times as it routinely tests patient samples. Findings include: The laboratory routinely tests patients for Rhesus factor (Rh factor) once, but review of proficiency testing records for the past two years on 05/16/2019 revealed that American Proficiency Institute (API) proficiency testing samples for Rh factor were tested more than once. For the first and second testing events of 2018, five testing personnel tested each of the five samples. For the third testing event of 2018, two testing personnel tested samples #11 and 14. For the first testing event of 2019, four testing personnel tested each of the five samples. During an interview with the manager at 11:00 a.m. on 05/16/2019, she confirmed that more than one testing person tested the proficiency test samples. 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 --