Planned Parenthood Of South Florida & Treasure

Summary Statement of Deficiencies D0000 A recertification survey was conducted on December 4, 2024- January 30, 2025. PLANNED PARENTHOOD OF SOUTH FLORIDA AND TREASURE DBA PLANNED PARENTHOOD OF SOUTH,EAST, NORTH FLORIDA clinical laboratory was not in compliance with 42 CFR 493, requirements for clinical laboratories. The following Conditions were not met: D5400 Analytic Systems 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 review of Proficiency Testing (PT) records, and interview, the Laboratory Director failed to sign the attestation forms for one (2023 2nd) of five (2023 1st, 2nd, 3rd, 2024 1st, 2nd) from the Kendall Laboratory in the specialty of Immunohematology and three (2024 1st, 2nd, 3rd) of six (2023 1st, 2nd, 3rd, 2024 1st, 2nd, 3rd) events for the West Palm Beach laboratory in the specialty of Endocrinology, and the Testing Personnel failed to sign the attestation forms for two (2024 1st, 3rd) of six (2023 1st, 2nd, 3rd, 2024 1st, 2nd, 3rd) events for the West Palm Beach laboratory in the specialty of Endocrinology. Findings Included: 1. Review of the American Proficiency Institute (API) PT instructions noted, "Signature Required - For all PT results, an attestation must be signed by testing personnel and the laboratory director and retained for a minimum of 2 years." 2. Review of the API PT attestation forms showed, the Laboratory Director had not signed the attestation for the 2023 2nd event for the Kendall laboratory in the specialty of Immunohematology, and 2024 1st, 2nd, and 3rd events for the West Palm Beach laboratory in the specialty of Endocrinology. 3. Review of the API PT attestation forms showed Testing Personnel had not signed the attestation for the 2024 1st and 3rd events for the West Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 9 -- Palm Beach laboratory in the specialty of Endocrinology. 4. On 12/05/2024 at 2:32 PM, the Health Center Manager acknowledge the attestations were not signed. 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 review of the American Proficiency Institute (API) proficiency testing (PT) records and interview, the laboratory failed to run proficiency testing samples the same number of times as it routinely tested patient samples for one (2024 2nd) of six (2023 1st, 2nd, 3rd, 2024 1st, 2nd, 3rd) events for the West Palm Beach laboratory in the specialty of Endocrinology and for one (2024 2nd) of five (2023 1st, 2nd, 3rd, 2024 1st, 2nd) from the West Palm Beach Laboratory in the specialty of Immunohematology. Findings Included: 1. The API PT company sends five samples to be tested per event. Review of the PT attestation form for the 2024 2nd event to Endocrinology listed nine names of the persons who performed the test. Review of the instrument printout showed each sample had two sets of results for each sample dated 05/21/2024 and 05/22/2024. Review of the API 2024 catalog noted the PT Results Due Date was 06/05/2024. 2. Review of the PT attestation form for the 2024 2nd event to Immunohematology listed eight names of the persons who performed the test. Review of the attestation showed for sample #6, #7, #8,and #9 each had the names of two Testing Personnel listed as the person performing the test and were all dated 08/09 /2024. Review of the API 2024 catalog noted the PT Results Due Date was 08/14 /2024. 3. On 12/05/2024 at 3:30 PM, the Health Center Manager acknowledge the proficiency testing samples were run more that once. D2093 ROUTINE CHEMISTRY CFR(s): 493.841(d) Failure to return proficiency testing results to the proficiency testing program within the time frame specified by the program is unsatisfactory performance and results in a score of 0 for the testing event. This STANDARD is not met as evidenced by: Based on review of API (American Proficiency Institute) proficiency testing (PT) records and interview, the laboratory failed to submit PT results for Human Chorionic Gonadotropin (hCG) within the time frame specified by API for one (2023 2nd) of six (2023 1st, 2nd, 3rd, 2024 1st, 2nd, 3rd) events for the Kendall laboratory, and failed to submit one (2023 2nd) of six (2023 1st, 2nd, 3rd, 2024 1st, 2nd, 3rd) events for the Port St Lucie laboratory. Findings Included: 1. Review of API Performance Summary for hCG at the Kendall laboratory noted, "Test results were not received by American Proficiency Institute." 2. Review of API Performance Summary for hCG at the Port St Lucie laboratory noted, "Test results were not received by American Proficiency Institute." 3. On 12/05/2024 at 2:00 PM, the Health Center Manager stated the laboratory failed to submit the PT results before the deadline. D2159 ABO GROUP AND D(RHO) TYPING CFR(s): 493.859(d) -- 2 of 9 -- Failure to return proficiency testing results to the proficiency testing program within the time frame specified by the program is unsatisfactory performance and results in a score of 0 for the testing event. This STANDARD is not met as evidenced by: Based on review of API (American Proficiency Institute) proficiency testing (PT) records and interview, the laboratory failed to submit PT results for Rh (Rhesus) test within the time frame specified by API for one (2023 2nd) of five (2023 1st, 2nd, 3rd, 2024 1st, 2nd) events for the West Palm Beach laboratory, and failed to submit one (2023 2nd) of five (2023 1st, 2nd, 3rd, 2024 1st, 2nd) events for the Port St Lucie laboratory. Findings Included: 1. Review of API Performance Summary for West Palm Beach revealed the laboratory received a score of 0% for the 2023 2nd event for Rh. 2. Review of API Performance Summary for Port St Lucie revealed the laboratory received a score of 0% for the 2023 2nd event for Rh. 3. On 12/05/2024 at 2:00 PM, the Health Center Manager stated the laboratory failed to submit the PT results before the deadline. . D5400 ANALYTIC SYSTEMS CFR(s): 493.1250 Each laboratory that performs nonwaived testing must meet the applicable analytic systems requirements in 493.1251 through 493.1283, unless HHS approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub.7), that provides equivalent quality testing. The laboratory must monitor and evaluate the overall quality of the analytic systems and correct identified problems as specified in 493.1289 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: Based on record review, and interview, the laboratory failed to complete their performance verification on the i-stat system for beta-human chorionic gonadotropin (b-hCG) for all 5 laboratory locations before patient testing (D5421) and failed to follow their unreviewed TOTAL BETA-HUMAN CHORIONIC GONADOTROPIN (b-hCG)(Moderate Complexity Test) Individualized Quality Control Plan for performing Liquid Controls, levels 1 and 3, on the first day of patient care every month for all their testing locations(D5445). D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) The laboratory must define criteria for those conditions that are essential for proper storage of reagents and specimens, accurate and reliable test system operation, and test result reporting. The criteria must be consistent with the manufacturer's instructions, if provided. These conditions must be monitored and documented and, if applicable, include the following: (1) Water quality. (2) Temperature. (3) Humidity. (4) Protection of equipment and instruments from fluctuations and interruptions in electrical current that adversely affect patient test results and test reports. This STANDARD is not met as evidenced by: Based on review of the i-Stat 1 System Manual and quality control records, and -- 3 of 9 -- interview, the laboratory failed to record the temperature and humidity of the laboratories at each location (West Palm Beach, Golden Glades, Kendall, Pembroke Pines, Treasure Coast) from 10/01/2022 to 12/05/2024. Findings Included: 1. Review of the i-Stat system manual revealed, the operating temperature for the i-Stat was 16- 30 degrees Celsius and the relative humidity was 10-90%. 2. Review of quality control records revealed the laboratory had not recorded the room temperature or the humidity of the laboratory in each location. 3. On 12/04/2024 at 12:10 AM, the Health Center Manager stated they did not know they had to record the room temperature and humidity, and they had not recorded them. D5421 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(1) Each laboratory that introduces an unmodified, FDA-cleared or approved test system must do the following before reporting patient test results: (1)(i) Demonstrate that it can obtain performance specifications comparable to those established by the manufacturer for the following performance characteristics: (1)(i)(A) Accuracy. (1)(i) (B) Precision. (1)(i)(C) Reportable range of test results for the test system. (1)(ii) Verify that the manufacturer's reference intervals (normal values) are appropriate for the laboratory's patient population. This STANDARD is not met as evidenced by: Based on record review, and interview, the laboratory failed to complete their performance verification on the i-stat system for beta-human chorionic gonadotropin (b-hCG) for all 5 laboratory locations before patient testing. Finding Included: 1. Review of Mango Health Center i-STAT SYSTEM VERIFICATION revealed it was not signed by a testing personnel and the laboratory director. There was no instrument documentation on calibration runs and quality control runs for the verification of b- hCG tested on the i-stat instrument. 2. Review of Pembroke Pines Health Center i- STAT SYSTEM VERIFICATION revealed it was not signed by a testing personnel and laboratory director. There was no instrument documentation on calibration runs and quality control runs for the verification of b-hCG tested on the i-stat instrument with i-stat serial numbers. 3. Review of Golden Glades Health Center i-STAT SYSTEM VERIFICATION revealed it was not signed by a testing personnel and laboratory director. There was no instrument documentation on calibration runs and quality control runs for the verification of b-hCG tested on the i-stat instrument with i- stat serial numbers. 4. Review of Kendall Health Center i-STAT SYSTEM VERIFICATION revealed it was not signed by a testing personnel and laboratory director. There was no instrument documentation on calibration runs and quality control runs for the verification of b-hCG tested on the i-stat instrument with i-stat serial numbers. 5. Review of Treasure Coast Health Center i-STAT SYSTEM VERIFICATION revealed it was not signed by a testing personnel and laboratory director. There was no instrument documentation on calibration runs and quality control runs for the verification of b-hCG tested on the i-stat instrument with i-stat serial numbers. 6. Review of patients' test log revealed the following: A. 249 patients were tested for b-hCG from September 1, 2023 to present at location Mango. B. 125 patients were tested for b-hCG from September 1, 2023 to present at location Golden Glades. C. 47 patients were tested for b-hCG from September 1, 2023 to present at location Kendall. D. 15 patients were tested for b-hCG from September 1,2023 to present at Pembroke Pines location. E. 26 patients were tested for b-hCG from September 1, 2023 to present at location Treasure Coast. 7. On 12/5/2024 at 6:25 PM, the Quality Risk Manger confirmed the i-stat verifications were incomplete. -- 4 of 9 -- D5445 CONTROL PROCEDURES CFR(s): 493.1256(d)(1)(2)(g) Unless CMS Approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing, the laboratory must-- (d)(1) Perform control procedures as defined in this section unless otherwise specified in the additional specialty and subspecialty requirements at 493.1261 through 493.1278. (d)(2) For each test system, perform control procedures using the number and frequency specified by the manufacturer or established by the laboratory when they meet or exceed the requirements in paragraph (d)(3) of this section. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on record review and interview, the laboratory failed to follow their unreviewed TOTAL BETA-HUMAN CHORIONIC GONADOTROPIN (b-hCG) (Moderate Complexity Test) Individualized Quality Control Plan for performing Liquid Controls, levels 1 and 3, on the first day of patient care every month for all their testing locations. Findings Included: 1. Review of the testing log revealed b-hCG testing was performed on the i-stat at 5(Mango, Golden Glades, Kendall, Pembroke Pines and Treasure Coast) out of 5 locations. 2. Review of TOTAL BETA-HUMAN CHORIONIC GONADOTROPIN (b-hCG) (Moderate Complexity Test) Individualized Quality Control Plan (IQCP) read, "Liquid Controls, levels 1 and 3, on the first day of patient care every month. Liquid Controls, levels 1 and 3, with each new shipment of cartridges." The plan was not signed by the Laboratory Director. There was no individualized quality control plan for the 5 (Mango, Golden Glades, Kendall, Pembroke Pines and Treasure Coast) out of 5 locations that performed b- hCG on the i-stat. 3A. Review of Mango patient testing log revealed the following: a. 13 patients were tested for b-hCG in August 2024 b. 9 patients were tested for b-hCG in June 2024 c. 2 patients were tested for b-hCG in September 2024 3B. Review of Treasure Coast patient testing log revealed the following: a. 2 patients were tested for b-hCG in November 2023 b. 2 patients were tested for b-hCG in December 2023 c. 2 patients were tested for b-hCG in January 2024 d. 1 patient was tested for b-hCG in February 2024 e. 6 patients were tested for b-hCG in April 2024 3C. Review of Pembroke Pines patient testing log revealed the following: a. 1 patient was tested for b-hCG in November 2023 b. 4 patients were tested for b-hCG in March 2024 c. 1 patient was tested for b-hCG in April 2024 3D. Review of Kendall patient testing log revealed the following: a. 2 patients were tested for b-hCG in November 2023 b. 1 patient was tested for b-hCG in December 2023 c. 5 patients were tested for b-hCG in March 2024 d. 20 patients were tested for b-hCG in May 2024 3E. Review of Golden Glades patient testing log revealed the following: a. 1 patient was tested for b-hCG in January 2024 b. 8 patients were tested for b-hCG in February 2024 c. 20 patients were tested for b-hCG in March 2024 d. 67 patients were tested for b-hCG in May 2024 4a. Review of Mango i-stat Quality Control revealed level 1 and 3 controls were not performed for the months of September 2023, June 2024 and August 2024. 4b. Review of Treasure Coast i-stat Quality Control revealed level 1 and 3 controls were not performed for the months of November 2023, December 2023, January 2024, February 2024 and April 2024. 4c. Review of Pembroke Pines i-stat Quality Control revealed level 1 and 3 controls were not performed for the months of November 2023, March 2024 and April 2024. 4d. Review of Kendall i-stat Quality Control revealed level 1 and 3 controls were not performed for the months of November 2023, December 2023, March 2024 and May 2024. 4e. Review of Golden Glades i-stat Quality Control revealed level 1 and 3 controls were not performed for the months of -- 5 of 9 -- January 2024, February 2024, March 2024 and May 2024. 5. On 12/5/2024 at 6:25 PM, the Quality Risk Manger confirmed the IQCP was not followed and quality controls were not performed at 5 out of 5 locations that performed b-hCG. D5781

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at Planned Parenthood of South Florida & Treasure on 09/26/2022 to 09/30/2022. The laboratory is not in compliance with 42 CFR Part 493, Requirement for Laboratories. On-site visits were made to all 6 multiple sites: Treasure Coast-1696 SE Hillmoor Drive in Port St. Lucie, Boca-8177 Glades Road Bay 25 in Boca Raton, FL Mango-2300 N FL Mango Rd. in West Palm Beach, Pembroke Pines-263 N University Drive in Pembroke Pines, Gold Glades- 585 NW 161st Street in Miami, and Kendall-8900 SW 117th Ave Suite 207B in Miami. 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 the Laboratory Director failed to delegate signing American Proficiency Institute (API) proficiency testing and performing competency evaluations on the Testing Personal to a person (Staff #PP) that would qualify as a Laboratory Director or a Technical Consultant for 2 out of 2 years (2020- 2022) reviewed (See D6004). D6004 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(a)(b) 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 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 -- and for assuring compliance with the applicable regulations. (a) The laboratory director, if qualified, may perform the duties of the technical consultant, clinical consultant, and testing personnel, or delegate these responsibilities to personnel meeting the qualifications of 493.1409, 493.1415, and 493.1421, respectively. (b) If the laboratory director reapportions performance of his or her responsibilities, he or she remains responsible for ensuring that all duties are properly performed. This STANDARD is not met as evidenced by: Based on record review and interview the Laboratory Director failed to delegate signing American Proficiency Institute (API) proficiency testing and performing competency evaluations on the Testing Personal to a person (Staff #PP) that would qualify as a Laboratory Director or a Technical Consultant for 2 out of 2 years (2020- 2022) reviewed. Findings Included: Review of API proficiency testing revealed that Staff #PP signed the attestations and reviews. Review of Competency evaluations on all 41 Testing Personnel revealed that all were signed by Staff #PP. Review of Staff #PP education revealed that she has a Doctor of Nursing Practice degree which does not qualify her to be the Laboratory director or a Technical Consultant. Interview on 09/26/2022 at 3:30 PM the Laboratory Manager confirmed that Staff #PP was performing competency evaluations and signing the API proficiency testing. 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 the laboratory failed to verify the accuracy of 1 (Testing Person #N) out of 41 Testing personnel (#A-#OO). 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 the laboratory failed to verify the accuracy of 1 (Testing Person #N) out of 41 Testing personnel (#A-#OO). Findings Included: Review of Testing Personnel #N documentation of education revealed a High School -- 2 of 3 -- diploma from Jamaica with no foreign equivalency. She was hired on 04/18/2022. Interview on 09/30/22 at 8:51 AM the Laboratory Manager confirmed that Testing Person #N did not have a foreign diploma equivalency. -- 3 of 3 --