Womens Center Of Hyde Park Llc

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at Women's Center of Hyde Park LLC on 07/09/2025. The laboratory is not in compliance with 42 CFR Part 493, Requirements for Laboratories. The following is a description of the standard level deficiencies: D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) (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 interview, it was determined the individual testing or examining of the samples failed to attest to the routine integration of the samples into the patient workload using the laboratory's routine methods for five ( 2nd event 2025, 1st, 2nd, and 3rd event of 2024, and 3rd event of 2023) of six (1st and 2nd event 2025, 1st, 2nd, and 3rd event of 2024, and 3rd event of 2023) for D(RHO) Typing testing. Findings included: 1. Review of proficiency records for 2nd event 2025, 1st, 2nd, and 3rd event of 2024, and 3rd event of 2023 for D(RHO) Typing testing failed to include indication of who performed the proficiency testing or an attestation that the testing was integration of the samples into the patient workload using the laboratory's routine methods. 2. Testing Personnel A confirmed on 7/09/2025 at 11:15 a.m. there was no indication of who performed the proficiency testing or an attestation that the testing was integration of the samples into the patient workload using the laboratory's routine methods 2nd event 2025, 1st, 2nd, and 3rd event of 2024, and 3rd event of 2023 for D(RHO) Typing testing. D2014 TESTING OF PROFICIENCY TESTING 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 2 -- (b)(6) The laboratory must document the handling, preparation, processing, examination, and each step in the testing and reporting of results for all proficiency testing samples. The laboratory must maintain a copy of all records, including a copy of the proficiency testing program report forms used by the laboratory to record proficiency testing results including the attestation statement provided by the PT program, signed by the analyst and the laboratory director, documenting that proficiency testing samples were tested in the same manner as patient specimens, for a minimum of two years from the date of the proficiency testing event. This STANDARD is not met as evidenced by: Based on record review and interview, the laboratory failed to document the handling, preparation, processing, examination, and each step in the testing and reporting of results for all proficiency testing samples for five ( 2nd event 2025, 1st, 2nd, and 3rd event of 2024, and 3rd event of 2023) of six (1st and 2nd event 2025, 1st, 2nd, and 3rd event of 2024, and 3rd event of 2023) for D(RHO) Typing testing. Findings included: 1. Review of proficiency records for 2nd event 2025, 1st, 2nd, and 3rd event of 2024, and 3rd event of 2023 for D(RHO) Typing testing failed to include the handling, preparation, processing, examination, and each step in the testing and reporting of results for all proficiency testing samples. 2. Testing Personnel A confirmed on 7/09/2025 at 11:15 a.m. there was no documentation of the handling, preparation, processing, examination, and each step in the testing and reporting of results for all proficiency testing samples for 2nd event 2025, 1st, 2nd, and 3rd event of 2024, and 3rd event of 2023 for D(RHO) Typing testing. 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, it was determined the laboratory failed to and evaluate the results obtained on proficiency testing for two (1st event of 2024 and 1st event of 2025) of six (1st and 2nd event 2025, 1st, 2nd, and 3rd event of 2024, and 3rd event of 2023) for D(RHO) Typing testing. Findings included: 1. Review of 1st event of 2024 and 1st event of 2025 records failed to include an evaluation of the results from the proficiency company. 2. The Laboratory Policy and Procedure Manual approved by the Laboratory Director 1/2/2025 included under, duties and responsibilities of the Laboratory Director, all proficiency reports are reviewed to evaluate the laboratory's performance. 3. Testing Personnel A confirmed on 7/09/2025 at 11:15 a.m., there was no evidence of evaluation of the results obtained on proficiency testing for the 1st event of 2024 and 1st event of 2025 for D(RHO) Typing testing. -- 2 of 2 --

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at Women's Center of Hyde Park, Inc. on 04/07/2021. The laboratory is 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) 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 of the CMS 209 Laboratory Personnel Report, laboratory procedure manual, and American Association of Bioanalysts (AAB) proficiency testing attestation records for Immunohematology and interview with Testing Personnel #A, the laboratory failed to have 1 testing personnel (#A ) out 2 testing personnel (#A and #B) rotate through the testing of proficiency for Immunohematology testing for two out of two (2019-2021) years reviewed. Findings included: Record review of the CMS 209 Laboratory Personnel Report signed by the Laboratory Director on 04/06/21 showed the laboratory had 2 testing personnel ( #A and #B). Record review of the laboratory's manual (signed by the Laboratory Director on 01/01/21) revealed "Section IX Laboratory Quality Assurance Proficiency Testing " procedure that stated "Proficiency testing samples are tested, to the extent possible, exactly like patient specimens, i. e. the same number of times and using the same personnel and methods as for patient testing." Record review of the AAB Immunohematology (D (rh) typing) proficiency testing records revealed that Testing Personnel #B had signed the attestation statement for 6 of 6 proficiency testing events (1st, 2nd, #3rd Event 2019, 1st and 3rd Event 2020, and 1st Event 2021). Interview on 04/07/2021 at 11:25 AM with Testing Personnel #A revealed she had performed Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 5 -- patient testing but had not performed AAB Immunohematology, D (rho) typing, proficiency testing for 2019-2021. D2015 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(5)(6) (5) The laboratory must document the handling, preparation, processing, examination, and each step in the testing and reporting of results for all proficiency testing samples. The laboratory must maintain a copy of all records, including a copy of the proficiency testing program report forms used by the laboratory to record proficiency testing results including the attestation statement provided by the PT program, signed by the analyst and the laboratory director, documenting that proficiency testing samples were tested in the same manner as patient specimens, for a minimum of two years from the date of the proficiency testing event. (6) PT is required for only the test system, assay, or examination used as the primary method for patient testing during the PT event. This STANDARD is not met as evidenced by: Based on interview with Testing Personnel #A and review of proficiency testing records and the procedure manual, the laboratory failed to maintain the Immunohematology proficiency testing result reports for 4 ( 1st, 2nd, and 3rd Events 2019 and 1st Event 2020) out of 5 testing events reviewed (2019 1st, 2nd, 3rd Events, and 2020 1st and 3rd Events). Findings included: Record review of American Association of Bioanalysts (AAB) proficiency testing documentation revealed there the laboratory had not retained the Immunohematology, D (rho) typing, proficiency testing results report for the 2019 1st , 2nd and 3rd Event and 2020 1st Event. Record review of the laboratory's procedure manual revealed that the "Section IX Laboratory Quality Assurance Proficiency Testing" stated "Proficiency Testing results are reviewed and retained for a period of 7 years." Interview on 04/07/2021 at 11:20 AM. with Testing Personnel #A revealed the laboratory had moved, and she could not find the AAB Immunohematology proficiency testing result reports for these events. D2155 ABO GROUP AND D(RHO) TYPING CFR(s): 493.859(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 American Association of Bioanalysts (AAB) proficiency testing record review and interview with Testing Personnel #A, the laboratory failed to notify AAB proficiency testing that the laboratory was closed which resulted in a score of zero percent (0%) for the Immunohematology analyte D (Rho) Typing for one event (2nd event in 2020) of seven events reviewed (1st, 2nd, #3rd Event 2019, 1st, 2nd, and 3rd -- 2 of 5 -- Event 2020, and 1st Event 2021). Findings included: Review of the American Association of Bioanalysts (AAB) records for Immunohematology for Quarter 2 2020 showed the laboratory received a score of "0.0 NR" (Not Reported to AAB) for the Immunohematology analyte D(Rho) Typing. Interview on 04/07/2020 at 11:30 AM with Testing Personnel #A revealed the laboratory was closed during the AAB Immunohematology 2020 2nd Event, and she did not know the laboratory needed to notify AAB that the laboratory closed while moving to another location. D5781