Advanced Womens Center

Summary Statement of Deficiencies D0000 The laboratory was found to be in substantial compliance with CLIA regulations 42 CFR Part 493. Standard level deficiencies were cited. D5445 CONTROL PROCEDURES CFR(s): 493.1256(d)(1)(2)(g) (d) 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. (d)(3) At least once each day patient specimens are assayed or examined perform the following for: This STANDARD is not met as evidenced by: Based on review of laboratory policy, quality control (QC) records, patient final reports and confirmed in interview, the laboratory failed to document quality control performance every 31 days prior to patient testing for 255 out of 292 patients tested in 2025. Findings included: 1. Review of laboratory policy, "BD Affirm: IQCP Quality Control Plan" (Approved by the Laboratory Director on 07/20/2016) revealed the following: " ...Frequency: a. Quality control cannot be performed less frequently than what is required by the BD Affirm manufacturer. b. Based upon IQCP risk assessment, evaluation and mitigation details, it has been determined that the specimen based Quality Control samples will be performed at a minimum of every 31 days." 2. Review of laboratory quality control records in 2025, revealed the following dates positive QC was documented: a. 01/09/2025 b. 04/01/2025 c. 07/18/2025 d. 10 /13/2025 (Note: Negative QC was not documented. Refer to D5481 I.) The laboratory was asked to provide QC performance for the eight of twelve events not documented 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 -- above. No documentation was provided. 3. Review of patient reports in 2026 revealed the following patients tested with no quality control documented within the 31-day timeframe: a. 03/02/2025-03/31/2025 Patients tested: 60 b. 05/02/2025-07/17/2025 Patients tested: 82 c. 08/11/2025-10/12/2025 Patients tested: 75 d. 11/13/2025-12/31 /2025 Patients tested: 38 4. In an interview on 07/01/2026 at 10:35 AM in the laboratory conference room, the Technical Consultant (TC-1) confirmed the laboratory failed to document quality control performance every 31 days prior to patient testing for the laboratory failed to document quality control performance every 31 days prior to patient testing for 255 out of 292 patients tested in 2025. D5481 CONTROL PROCEDURES CFR(s): 493.1256(f)(g) (f) Results of control materials must meet the laboratorys and, as applicable, the manufacturers test system criteria for acceptability before reporting patient test results. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: I. Based on review of laboratory policy, quality control (QC) records, patient final reports, and confirmed in interview, the laboratory failed to document external negative control material at least once per patient testing day for the Vaginal Microbial Identification Test on the BD Affirm analyzer for 4 of 4 testing days in 2025. Findings Included: 1. Review of laboratory policy titled, "BD Affirm: IQCP Quality Control Plan" (Approved by the Laboratory Director on 07/20/2016) revealed the following: "Quality Control Documentation- Documentation of Quality Control, Maintenance, and Environmental logs must be made "real time" as part of daily responsibilities." 2. Review of laboratory BD Affirm quality control records revealed the following patient testing days external negative quality control was not documented in 2025: a. 01/09/2025 b. 04/01/2025 c. 07/18/2025 d. 10/13/2025 3. Review of laboratory final patient reports revealed the laboratory tested 292 patient specimens on the BD Affirm analyzer in 2025. 4. In an interview with the Technical Consultant (TS-1) on 07/01/2026 at 11:16 AM, TS-1 confirmed the above findings. II. Based on review of laboratory policy, quality control (QC) records, patient final reports, and confirmed in interview, the laboratory failed to document external positive control material at least once per patient testing day for the GeneXpert Dx Cepheid analyzer for 6 of 6 testing days in March 2026. Findings Included: 1. Review of laboratory policy titled, "GeneXpert Dx: IQCP Quality Control Plan" (Approved by the Laboratory Director on 07/20/2016) revealed the following: "Quality Control Documentation- Documentation of Quality Control, Maintenance, and Environmental logs must be made "real time" as part of daily responsibilities." 2. Review of laboratory GeneXpert quality control records revealed the following patient testing days external positve quality control was not documented in 2025: a. 03/12/2026 b. 03 /13/2026 c. 03/14/2026 d. 03/15/2026 e. 03/16/2026 f. 03/17/2026 3. Review of laboratory final patient reports revealed the laboratory tested 73 patients on the above testing days with no positive control documented in March 2025. 4. In an interview on 07/01/2026 at 10:30 AM in the laboratory conference room, the Technical Consultant (TC-1) confirmed the laboratory failed to document external positive control material at least once per patient testing day for the GeneXpert Dx Cepheid analyzer for 6 of 6 testing days in March 2026. D5791 ANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1289(a)(c) -- 2 of 3 -- (a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and when indicated, correct problems identified in the analytic systems specified in 493.1251 through 493.1283. This STANDARD is not met as evidenced by: Based on surveyor observation, review of laboratory documentation, patient final reports and staff interview, the laboratory failed to establish and follow written policies and procedures for an ongoing mechanism to monitor, assess and when indicated, correct problems identified in the analytic systems for 12 of 12 months in 2025 (January-December), as evidenced by: 1. The laboratory failed to document external negative control material at least once per patient testing day for the Vaginal Microbial Identification Test on the BD Affirm analyzer for 4 of 4 testing days in 2025. Refer to D5481 I. 2. The laboratory failed to document external positive control material at least once per patient testing day for the GeneXpert Dx Cepheid analyzer for 6 of 6 testing days in March 2026. Refer to D5481 II. 3. The laboratory failed to document quality control performance every 31 days prior to patient testing for 255 out of 292 patients tested in 2025. Refer to D5445. D6053 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) (b)(9) Evaluating and documenting the performance of individuals responsible for moderate complexity testing at least semiannually during the first year the individual tests patient specimens. This STANDARD is not met as evidenced by: Based on review of the Centers for Medicare and Medicaid (CMS)-209 form, review of the laboratory's competency documentation, and confirmed in interview, the laboratory failed to ensure two semi-annual competency assessments were documented on all instruments within the first year of training for one of one testing person performing moderate complexity testing from June 2025-June 2026. Findings included: 1. Review of the CMS-209 form determined testing person-1 (TP-1) was performing moderate complexity testing on the GeneXpert and BD Affirm analyzers, starting in June 2025. 2. Review of laboratory testing person-1 (TP-1) competency assessments in 2025 and 2026, revealed the following: a. Instrument/Procedure name: GeneXpert Date performed: 12/01/2025 b. Instrument/Procedure name: BD Affirm Date performed: 12/01/2025 The laboratory was asked to provide a second competency assessment in the first year of patient testing for TP-1 on the above instruments. No documentation was provided. 3. In an interview on 07/01/2026 at 10: 35 AM in the laboratory conference room, the Technical Consultant (TC-1) confirmed the laboratory failed to ensure two semi-annual competency assessments were documented on all instruments within the first year of training for one of one testing person performing moderate complexity testing from June 2025-June 2026. -- 3 of 3 --

Summary Statement of Deficiencies D0000 Based on a proficiency testing desk review survey performed on April 24, 2025, the laboratory was found to be out of compliance based on the following CONDITION LEVEL DEFICIENCIES: D2016 - 42 C.F.R. 493.803 Condition: Successful participation D6000 - 42 C.F.R. 493.1403 Condition: Laboratory Director, moderate complexity D2016 SUCCESSFUL PARTICIPATION CFR(s): 493.803(a)(b)(c) (a) Each laboratory performing nonwaived testing must successfully participate in a proficiency testing program approved by CMS, if applicable, as described in subpart I of this part for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. (b) Except as specified in paragraph (c) of this section, if a laboratory fails to participate successfully in proficiency testing for a given specialty, subspecialty, analyte or test, as defined in this section, or fails to take remedial action when an individual fails gynecologic cytology, CMS imposes sanctions, as specified in subpart R of this part. (c) If a laboratory fails to perform successfully in a CMS- approved proficiency testing program, for the initial unsuccessful performance, CMS may direct the laboratory to undertake training of its personnel or to obtain technical assistance, or both, rather than imposing alternative or principle sanctions except when one or more of the following conditions exists: (1) There is immediate jeopardy to patient health and safety. (2) The laboratory fails to provide CMS or a CMS agent with satisfactory evidence that it has taken steps to correct the problem identified by the unsuccessful proficiency testing performance. (3) The laboratory has a poor compliance history. This CONDITION is not met as evidenced by: Based on review of the Certification and Survey Provider Enhanced Reporting (CASPER) Report 155 Individual Laboratory Profile and American Proficiency Institute's proficiency reports, the laboratory failed to achieve satisfactory 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 -- performance in two of two testing events for the subspecialty bacteriology, resulting in an initial unsuccessful performance. Refer to D2028. D2028 BACTERIOLOGY CFR(s): 493.823(e) (e) Failure to achieve an overall testing event score of satisfactory performance for two consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on review of the Certification and Survey Provider Enhanced Reporting (CASPER) Report 155 Individual Laboratory Profile and American Proficiency Institute's proficiency reports, the laboratory failed to achieve satisfactory performance for two of two events in 2024 and 2025 for the subspecialty of bacteriology. The findings included: 1. Based on review of the Certification and Survey Provider Enhanced Reporting (CASPER) Report 155 Individual Laboratory Profile report, the laboratory received the following unsatisfactory performances for bacteriology in two of two events: 2024 API 3rd event 0% 2025 API 1st event 0% 2. Based on review of the American Proficiency Institute's proficiency reports, the laboratory received the following unsatisfactory performances for bacteriology in two of two events: 2024 API 3rd event 0% 2025 API 1st event 0% 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 desk review of the Certification and Survey Provider Enhanced Reporting (CASPER) Report 155 Individual Laboratory Profile and American Proficiency Institute's proficiency reports, the laboratory director failed to provide overall management and direction of the laboratory services. Refer to D6016. D6016 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(i) (e)(4)(i) The proficiency testing samples are tested as required under Subpart H of this part; This STANDARD is not met as evidenced by: Based on desk review of the Certification and Survey Provider Enhanced Reporting (CASPER) Report 155 Individual Laboratory Profile and American Proficiency Institute's proficiency reports, the laboratory director failed to ensure successful participation in a HHS approved proficiency testing program for the subspecialty of bacteriology for two of two events in 2024 and 2025, resulting in an initial unsuccessful performance. Refer to D2028. -- 2 of 2 --

Summary Statement of Deficiencies 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 review of the laboratory's instrumentation, and staff interview, the laboratory failed to have documentation of performing verification studies on 1 of 1 Cepheid Xpert CT/GC analyzers. The findings included: 1. A review of the laboratory's instrumentation determined the laboratory placed a new Cepheid Xpert CT /GC analyzer (serial number 10019198) in use in March 2023. 2. The laboratory failed to have documentation of performing verification studies (accuracy, precision) on the new analyzer. 3. The laboratory reported performing 4600 tests annually. 4. The technical consultant confirmed the findings in an interview conducted on 05/20/2024 at 1000 hours in the break room. Key CT - chlamydia GC - gonorrhea 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 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 -- 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 review of the laboratory's instrumentation, review of the laboratory's Individualized Quality Control Plan (IQCP) for the Cepheid Xpert, and staff interview, the laboratory failed to have documentation of developing an IQCP for 1 of 1 Cepheid Xpert CT/NG analyzers. The findings included: 1. A review of the laboratory's instrumentation determined the laboratory placed a new Cepheid Xpert CT /GC analyzer (serial number 10019198) in use in March 2023. 2. The laboratory performed quality control testing with each new shipment and lot of test cartridges. 3. The laboratory failed to have documentation of developing an IQCP which included the new analyzer. 4. The laboratory reported performing 4600 tests annually. 5. On 05 /20/2024 at 1030 hours in the break room, the technical consultant stated this wasn't required according to an accrediting agency and the laboratory did not need to develop an IQCP which included the new analyzer. Key CT - chlamydia NG - gonorrhea -- 2 of 2 --

Summary Statement of Deficiencies D0000 Noted deficiencies and plans of correction were discussed with the laboratory representatives at the entrance and exit conferences. The facility representatives were given an opportunity to provide evidence of compliance with the noted deficiency, and no such evidence was provided prior to survey exit. The facility was found to be in compliance with applicable Conditions of Participation in the CLIA program, and certification is recommended. Note: The CMS-2567 (Statement of Deficiencies) is an official, legal document. All information must remain unchanged except for entering the

Summary Statement of Deficiencies D0000 Noted deficiencies and plans of correction were discussed with the laboratory representative at the entrance and exit conferences. The facility representative was given an opportunity to provide evidence of compliance with the noted deficiencies, and no such evidence was provided prior to survey exit. The facility was found to be in compliance with applicable Conditions of Participation in the CLIA program, and recertification is recommended. Note: The CMS-2567 (Statement of Deficiencies) is an official, legal document. All information must remain unchanged except for entering the

Summary Statement of Deficiencies D0000 The laboratory was found to be out of compliance based on the following CONDITION LEVEL DEFICIENCIES resulting in a finding of IMMEDIATE JEOPARDY: D5400 - 42 C.F.R. 493.1250 Condition: Analytic Systems D6000 - 42 C.F.R. 493.1403 Condition: Laboratory Director; moderate complexity D6033 - 42 C. F.R. 493.1409 Condition: Technical Consultant D6063 - 42 C.F.R. 493.1421 Condition: Testing Personnel; moderate complexity Noted deficiencies and plans of correction were discussed with the laboratory representative at the exit conference. The facility representative was given an opportunity to provide evidence of compliance with noted deficiencies and no such evidence was provided prior to survey exit. Note: The CMS-2567 (Statement of Deficiencies) is an official, legal document. All information must remain unchanged except for entering the