Planned Parenthood Of Southwest & Central Fl

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at Planned Parenthood of Southwest & Central FL, Inc on 6/26-6/30/25. The laboratory is not in compliance with 42 CFR Part 493, Requirement for Laboratories. The following Conditions were cited: D6063 493.1421 Condition: Laboratory Testing Personnel 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 record review and interview, the laboratory failed to verify the accuracy of Chemistry (serum-quant) HCG pregnancy evaluation for 2nd event of 2024, they were assigned a proficiency testing scores that did not reflect laboratory test performance. Findings included: 1. The American Proficiency Institute (API) proficiency performance evaluation for Chemistry (serum-quant) HCG pregnancy for 2nd event of 2024 documented for HCG-06, HCG-07, and HCG-10 performance as,"Not Graded" and "See Data Summary". The Performance Review and

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at Planned Parenthood of Southwest and Central FL, Inc. on 01/28/2021 and 02/04/2021. The laboratory is not in compliance with 42 CFR Part 493, Requirement for Laboratories. The following Conditions were cited: D6000-Moderate Complexity Laboratory Director: 493.1403 D6063-Laboratory Testing Personnel: 493.1421 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 record review and interview with the Senior Manager of Compliance, Quality & Risk Management the Laboratory Director failed to verify the education of 2 (#B and #E) out of 7 (#A, #B, #C, #D, #E, #F, and #G) Testing Personnel (See D6028). D6028 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(10) 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)(10) Employ a sufficient number of laboratory personnel with the appropriate education and either experience or training to provide appropriate consultation, properly supervise and accurately perform tests and report test results in accordance with the personnel responsibilities described in this subpart; 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 -- This STANDARD is not met as evidenced by: Based on record review and interview with the Senior Manager of Compliance, Quality & Risk Management the Laboratory Director failed to verify the education of 2 (#B and #E) out of 7 (#A, #B, #C, #D, #E, #F, and #G) Testing Personnel. Findings Included: Review of personnel files revealed no proof of education for Testing Person #B and #E. Interview on 02/04/2021 at 8:39 AM via email from the Senior Manager of Compliance, Quality & Risk Management confirmed that the laboratory did not have proof of high school diplomas for Testing Person #B and #E. 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 record review and interview with the Senior Manager of Compliance, Quality & Risk Management the laboratory failed to verify the education of 2 (#B and #E) out of 7 (#A, #B, #C, #D, #E, #F, and #G) Testing Personnel (See D6065). D6065 TESTING PERSONNEL QUALIFICATIONS 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 record review and interview with the Senior Manager of Compliance, Quality & Risk Management the laboratory failed to verify the education of 2 (#B and #E) out of 7 (#A, #B, #C, #D, #E, #F, and #G) Testing Personnel. Findings Included: Review of personnel files revealed no proof of education for Testing Person #B and #E. Interview on 02/04/2021 at 8:39 AM via email from the Senior Manager of Compliance, Quality & Risk Management confirmed that the laboratory did not have proof of high school diplomas for Testing Person #B and #E. -- 2 of 2 --

Summary Statement of Deficiencies D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) Reagents, solutions, culture media, control materials, calibration materials, and other supplies must not be used when they have exceeded their expiration date, have deteriorated, or are of substandard quality. This STANDARD is not met as evidenced by: Based on record review and interview with the Office Manager, the laboratory failed to ensure that blood used for immunohematology quality controls were not expired prior to being used for 2 days in the 2 years (2017, 2018) reviewed. Findings Included: Review of the "NTP Health Center Rh Log" Sheet revealed on 07/07/2018 and 07/11/2018 the blood used for positive and negative controls expired on 07/06 /2018. Review of patient charge records for 07/07/2018 revealed 16 patients had been tested and 16 patients had been tested on 07/11/2018. Interview on 01/22/18 at approximately 11:00 AM, Office Manager confirmed that the documentation on the logs indicated that expired blood was used for quality controls. 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 --