Planned Parenthood Of Southwest And Central

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at Planned Parenthood of Southwest and Central Florida Inc on May 15, 2025. The laboratory is not in compliance with 42 CFR Part 493, Requirement for Laboratories. The following Condition was cited: D6033 - 493.1409 Condition: Technical Consultant 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. This STANDARD is not met as evidenced by: Based on record review and interview, the Laboratory failed to create a competency assessment policy and perform initial competency assessments for 1 out of 1 Technical Consultant (A) in 2025. Findings Included: 1. On 5/15/2025 at 1:15 PM, the Center Manager stated Technical Consultant A was hired on 4/1/2025. Review of 2025 Competency assessments revealed Technical Consultant A had no documentation of initial competency assessments done in 2025. 2. Review of competency assessment policy revealed there was no policy for competency assessment. 3. On 5/15/2025 at 1:08 PM, the Center Manager stated initial competency assessments in 2025 were not documented for Technical Consultant A. D6033 TECHNICAL CONSULTANT-MODERATE COMPLEXITY CFR(s): 493.1409 The laboratory must have a technical consultant who meets the qualification requirements of 493.1411 of this subpart and provides technical oversight in accordance with 493.1413 of 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 3 -- This CONDITION is not met as evidenced by: Based on record review and interview, the Laboratory failed to have qualified Technical Consultants for 1 out of 1 Technical Consultant (A) sampled for testing for Human Chorionic Gonadotropin (HCG). (D6035) D6035 TECHNICAL CONSULTANT QUALIFICATIONS CFR(s): 493.1411 (a) The technical consultant must be qualified and must possess a current license issued by the State in which the laboratory is located, if such licensing is required. (b) The technical consultant must-- (b)(1)(i) Be a doctor of medicine or doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located; and (b)(1)(ii) Be certified in anatomic or clinical pathology, or both, by the American Board of Pathology or the American Osteopathic Board of Pathology; or (b)(2)(i) Be a doctor of medicine, doctor of osteopathy, or doctor of podiatric medicine licensed to practice medicine, osteopathy, or podiatry in the State in which the laboratory is located; AND (b)(2)(ii) Have at least 1 year of laboratory training or experience, or both, in nonwaived testing, in the designated specialty or subspecialty areas of service for which the technical consultant is responsible (for example, physicians certified either in hematology or hematology and medical oncology by the American Board of Internal Medicine are qualified to serve as the technical consultant in hematology); or (b)(3)(i)(A) Hold an earned doctoral or master's degree in a chemical, biological, clinical or medical laboratory science, or medical technology from an accredited institution; or (b)(3)(i)(B) Meet either requirements in 493.1405(b)(3)(i)(B) or (b)(4)(i)(B) or (C); AND (b)(3)(ii) Have at least 1 year of laboratory training or experience, or both, in nonwaived testing, in the designated specialty or subspecialty areas of service for which the technical consultant is responsible; or (b)(4)(i)(A) Have earned a bachelor's degree in a chemical, biological, clinical or medical laboratory science, or medical technology from an accredited institution; or (b)(4)(i)(B) Meet 493.1405(b)(5)(i)(B); and (b)(4)(ii) Have at least 2 years of laboratory training or experience, or both, in nonwaived testing, in the designated specialty or subspecialty areas of service for which the technical consultant is responsible; or (b)(5)(i) Have earned an associate degree in medical laboratory technology, medical laboratory science, or clinical laboratory science; and (b)(5)(ii) Have at least 4 years of laboratory training or experience, or both, in nonwaived testing, in the designated specialty or subspecialty areas of service for which the technical consultant is responsible. (b)(6) For blood gas analysis, the individual must- (b)(6)(i) Be qualified under paragraph (b)(1), (2), (3) or (4) of this section; or (b)(6)(ii)(A) Have earned a bachelor's degree in respiratory therapy or cardiovascular technology from an accredited institution; and (b)(6)(ii)(B) Have at least 2 years of laboratory training or experience, or both, in blood gas analysis; or (b) (7) Notwithstanding any other provision of this section, an individual is considered qualified as a technical consultant under this section if they were qualified and serving as a technical consultant for moderate complexity testing in a CLIA-certified laboratory as of December 28, 2024, and have done so continuously since December 28, 2024. This STANDARD is not met as evidenced by: Based on record review and interview, the Laboratory failed to have qualified Technical Consultants for 1 out of 1 Technical Consultant (A) sampled for testing of Human Chorionic Gonadotropin (HCG). Findings included: 1. Review of Laboratory -- 2 of 3 -- Personnel Report CMS 209 signed by the Laboratory Director revealed Technical Consultant A was listed as Technical Consultant. 2. Review of Technical Consultant A's resume form revealed no documentation for a year of laboratory experience listed. 3. Review of Laboratory Director's delegation form revealed the Laboratory Director signed a delegation without a date to delegate Laboratory Director's duties to the Technical Consultant. 4. Review of laboratory training /competency verification assessments revealed Testing Personnel A had an annual competency assessment done on 04/08/2025 and was signed by the Technical Consultant on 4/8/2025 for HCG testing. 5. On 04/07/2025 at 6:43 PM, the Office Manager confirmed Technical Consultant A was not qualified for moderate complexity testing due to lack of experience. -- 3 of 3 --

Summary Statement of Deficiencies D0000 A recertification survey was conducted on October 31, 2022. Planned Parenthood of Southwest and Central Florida clinical laboratory was not in compliance with 42 CFR 493, requirements for clinical laboratories. D5437 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(a) Unless otherwise specified in this subpart, for each applicable test system the laboratory must perform and document calibration procedures-- (1) Following the manufacturer's test system instructions, using calibration materials provided or specified, and with at least the frequency recommended by the manufacturer; (2) Using the criteria verified or established by the laboratory as specified in 493.1253(b) (3)-- (2)(i) Using calibration materials appropriate for the test system and, if possible, traceable to a reference method or reference material of known value; and (2)(ii) Including the number, type, and concentration of calibration materials, as well as acceptable limits for and the frequency of calibration; and (3) Whenever calibration verification fails to meet the laboratory's acceptable limits for calibration verification. This STANDARD is not met as evidenced by: Based on record review and interview, the laboratory failed to provide documentation of calibration for Total Beta-Human Chorionic Gonadotropin (B-hCG) testing on the Abbott i-Stat analyzer at least every six months from 11/21/2021 to 10/31/2022. Findings: Review of the i-Stat System Manual noted "In the United States, laboratory regulations (CLIA) requires that tests categorized as Non-Waived, a calibration verification procedure be performed and documented at least every six months." Review of the laboratory's procedure for i-Stat Testing under "Twice Yearly Quality Control Procedures" listed "Perform calibration verification using all three levels of calibration verification solution." Review of the calibration records revealed the last calibration documentation available for review on the i-Stat was dated 11/20/2021. On 10/31/2022 at 12:55 PM, Testing Personnel B stated he was unable to locate 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 -- calibration records for 2022. Word Key CLIA - Clinical Laboratory Improvement Amendments D5805 TEST REPORT CFR(s): 493.1291(c) The test report must indicate the following: (c)(1) For positive patient identification, either the patient's name and identification number, or a unique patient identifier and identification number. (c)(2) The name and address of the laboratory location where the test was performed. (c)(3) The test report date. (c)(4) The test performed. (c)(5) Specimen source, when appropriate. (c)(6) The test result and, if applicable, the units of measurement or interpretation, or both. (c)(7) Any information regarding the condition and disposition of specimens that do not meet the laboratory's criteria for acceptability. This STANDARD is not met as evidenced by: Based on record review and interview, the laboratory failed to include address of the laboratory on the laboratory test results reports given to six of six patients (#1, #2, #3, #4, #5, #6), and failed to include the units of measurement on the laboratory test results reports for three of three patients (#1, #2, #3) tested for Total Beta-Human Chorionic Gonadotropin (B-hCG) on the Abbott i-Stat analyzer. Findings: Review of patients' laboratory test results showed the address of the laboratory where the testing was performed was not listed on six of six patient reports reviewed, (#1, #2, #3, #4, #5, #6). Review of the instrument test printout showed the units of measurement for B- hCG performed on the i-Stat listed the units of measurement as "IU/L" (International Unit/Liter). Review of the laboratory test results reports showed the unit of measurement was not listed on three of three patients' reports (#1, #2, #3) tested for B- hCG. According to the Clinical Laboratory Improvement Amendment (CLIA) Application for Certification, signed and dated by the Laboratory Director on 10/28 /2022, the laboratory had an annual test volume of 2,984 tests, of that 298 tests were listed under the subspecialty of Endocrinology (B-hCG testing). On 10/31/2022 at 1: 20 PM, Testing Personnel B stated the address and units of measurement were not on the reports. -- 2 of 2 --

Summary Statement of Deficiencies 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 Director failed to document the review and evaluation of proficiency testing (PT) for 5 out of 6 testing events reviewed. Findings: Review of American Proficiency Institute (API) proficiency testing results showed that the laboratory director failed to sign the "Proficiency Testing Performance Evaluation" for the Immunology/Immunohematology PT for the 1st, 2nd, and 3rd events in 2017, and the 1st and 2nd testing events in 2018. During an interview on 11/26/18 at 9:50 AM, the Office Manager acknowledged that the performance evaluation forms were not signed. 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 --