Women's Center Of Fort Lauderdale, Llc

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at WOMEN'S CENTER OF FORT LAUDERDALE, LLC from 07/18/2025 to 07/24/2025. The laboratory was not in compliance with 42 CFR Part 493, Requirement for Laboratories. The following Condition was cited: D6063 CFR 493.1421 Laboratory Testing Personnel. 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 two testing personnel (TP) rotate through the testing of Proficiency Testing (PT) in the Specialty of Immunohematology in 2024 and 2025. Findings included: 1-Review of FORM CMS-209 signed and dated by the Laboratory Director (LD) on 07/17/2025 revealed the laboratory had two TP listed (TP#1 and TP#2). 2-Review of personnel records for TP#2 revealed that she had competency evaluation on 2024 and 2025. 3- Review of American Association of Bioanalysts /Medical Laboratory Evaluation (AAB/MLE) PT records for 2024 (first, second and third event) and 2025 (first and second event) in the specialty of Immunohematology, revealed that TP#2 had no PT participation. 4-During an interview on 07/18/2025 at 12:30 PM, with TP#1 she explained that both TPs do the PT and confirmed that there was no documentation that TP#2 participated in PT during this period. D2155 ABO GROUP AND D(RHO) TYPING CFR(s): 493.859(c) 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 -- (c) Failure to participate in a testing event is unsatisfactory performance and results in a score of 0 for the testing event. Consideration may be given to those laboratories failing to participate in a testing event only if-- (1) Patient testing was suspended during the time frame allotted for testing and reporting proficiency testing results; (2) The laboratory notifies the inspecting agency and the proficiency testing program within the time frame for submitting proficiency testing results of the suspension of patient testing and the circumstances associated with failure to perform tests on proficiency testing samples; and (3) The laboratory participated in the previous two proficiency testing events. This STANDARD is not met as evidenced by: Based on record review and staff interview, the laboratory failed to submit the Proficiency Testing (PT) results for Immunohematology specialty in one out of five events reviewed for 2024 and 2025 and failed to do a review of the results. Findings included: 1-Review of American Association of Bioanalysts /Medical Laboratory Evaluation (AAB/MLE) PT records for 2024 (first, second and third event) and 2025 (first and second event) in the specialty of Immunohematology, revealed that the laboratory failed to submit the results for the first event of 2024 for the test of Rhesus (RH) factor and this resulted in a 0% score due to fail to submit PT results on time, the due date for this event was 02/23/2024. 2-Review of laboratory handwritten results note (Note#1) for that event showed results with no date and an undated note that stated" Results not submitted, write lab deviation report. No patients were harmed." 3- Review of the "LABORATORY DEVIATION REPORT FORM" signed on 02/24/2024 by the Laboratory Director stated that the laboratory failed to submit the results for the first event of 2024, two employees will be responsible for making sure results are entered in a timely matter." 4-Review of Note#2 written in the page of the AAB/MLE instructions for the 1st event of 2024, revealed, "Keep results once summary is issued 3 weeks make self-evaluation." The laboratory had no documentation that made a comparison with the results for a self-evaluation. 5-During an interview on 07/18/2025 at 12:35 PM, with TP#1 she explained that she did an online review of the results and confirmed that she did not have documentation of this review. 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 staff interview, the Laboratory failed to verify the education of 1 out of 2 Testing Personnel performing the Rhesus (Rh) factor test. 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 (b)(2) Have earned a doctoral, master's, or bachelor's degree -- 2 of 3 -- in a chemical, biological, clinical or medical laboratory science, or medical technology, or nursing from an accredited institution; or (b)(3) Meet the requirements in 493.1405(b)(3)(i)(B), (b)(4)(i)(B), (b)(4)(i)(C) or (b)(5)(i)(B); or (b)(4) Have earned an associate degree in a chemical, biological, clinical or medical laboratory science, or medical laboratory technology or nursing from an accredited institution; or (b)(5) Be a high school graduate or equivalent and have successfully completed an official military medical laboratory procedures course of at least a duration of 50 weeks and have held the military enlisted occupational specialty of Medical Laboratory Specialist (Laboratory Technician); or (b)(6)(i) Have earned a high school diploma or equivalent; and This STANDARD is not met as evidenced by: Based on record review and staff interview, the laboratory failed to verify the education of 1 out of two testing personnel (TP). Findings included: 1-Review of FORM CMS-209 Laboratory Personnel Report dated and signed by the Laboratory Director on 07/14/2025 listed 2 TP (TP#1 and TP#2). 2-Review of employee files revealed that TP#2 had Competency evaluations in 2024 and 2025 and the diploma was a copy of a Foreign High School Diploma, no equivalence for that diploma submitted. 3-Review of Patient log for the years 2024 to 2025, she did testing for Rhesus (RH) factor during this period. 4-During an interview on 07/18/2025 at 12:35 PM with TP#1, she confirmed that the laboratory failed to have documentation to proof that the TP#2 fulfill the minimum education requirement. -- 3 of 3 --

Summary Statement of Deficiencies D0000 An unannounced complaint survey, #2022001460, was conducted on February 3, 2022. Women's Center of Fort Lauderdale clinical laboratory was not in compliance with 42 CFR 493, requirements for clinical laboratories. D3009 FACILITIES CFR(s): 493.1101(c) The laboratory must be in compliance with applicable Federal, State, and local laboratory requirements. This STANDARD is not met as evidenced by: Based on record review and interview, the laboratory failed to follow federal regulations requiring the laboratory notify HHS (Department of Health and Human Services) or its designee (Agency for Health Care Administration), within 30 days of changing Laboratory Director on 02/18/2020 and address on 11/18/2020. Findings: Review of the "State Operations Manual Appendix C - Survey Procedures and Interpretive Guidelines for Laboratories and Laboratory Services," in Regulation 493.51 Notification requirements for laboratories issued a certificate of compliance noted "Laboratories issued a certificate of compliance must meet the following conditions: (a) Notify HHS or its designee within 30 days of any change in-- (1) Ownership; (2) Name; (3) Location; (4) Director . . . .)" Review of an application to change Laboratory Directors, signed on 02/18/2020 by the new Laboratory Director, showed the application was incomplete. Laboratories are notified if their application is incomplete. Any application deemed incomplete and not corrected within 30 days is withdrawn. The following information was not filled in on the application: where to send the fee coupon and certificate, name of the new Laboratory Director and his credentials, type of certificate, list of non-waived tests performed, type of control, and list of laboratories the Laboratory Director is affiliated with. Review of the procedure manual showed the new Laboratory Director approved the procedures on 02/18/20. 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 -- No documentation of the change of address was available for review. On 02/03/2022 at 11:02 AM, the Administrator stated they moved the laboratory on 11/18/2020. On 02/03/2022 at 11:31 AM, the Administrator stated the laboratory filled out an application to change Laboratory Director 02/18/2020, but was not aware the application was incomplete or if the laboratory received email notification of the corrections needed to be made on the application -- 2 of 2 --

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at Women's Center of Fort Lauderdale on 11/19/19. The laboratory is not in compliance with 42 CFR Part 493, Requirements for Laboratories. The following is a description of the standard level 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 used expired negative control for Rh typing for 5 days (08/14/18, 08/15/18, 08/16/18, 08/17 /18, and 08/18/18) out of 4 months reviewed (09/19, 06/19, 08/18, and 05/18). Findings Included: Review of daily lab logs revealed on 08/14/18, 08/15/18, 08/16/18, 08/17/18, and 08/18/19 the negative control for Anti-D Rh testing expired on 08/12 /18. There were 5 patients tested on 08/14/19, 7 patients on 08/15/18, 3 patients on 08 /16/18, 2 patients on 08/17/18, and 13 patients on 08/18/18. Interview on 11/19/19 at 11:00 AM the Office Manager confirmed that the logs showed an expired negative control was used on the aforementioned dates. 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 --