Women's Cancer & Wellness Institute

Summary Statement of Deficiencies D0000 An unannounced, off-site CLIA proficiency testing (PT) desk review was conducted for Women's Cancer & Wellness Institute on February 11, 2026 by the Virginia Department of Health's Office of Licensure and Certification. The laboratory was surveyed under 42 CFR part 493 CLIA Requirements. Specific deficiencies cited are as follows and includes the Conditions under 42 CFR part 493 CLIA Regulation: D2016 - 42 CFR. 493.803 Condition: Successful Participation, D6000 - 42 CFR. 493.1403 Condition: Laboratories performing moderate complexity testing- Laboratory Director. 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: 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 -- Based on a review of the Certification and Survey Provider Enhanced Reporting (CASPER) 0155 report, the laboratory's proficiency testing records and interview, the laboratory failed to successfully participate within the Chemistry specialty for Potassium (K) analyte. The laboratory had unsatisfactory K scores for the second and third events of calendar year 2025. Refer to D2088. D2088 ROUTINE CHEMISTRY CFR(s): 493.841(b) (b) Failure to attain an overall testing event score of at least 80 percent is unsatisfactory performance. This STANDARD is not met as evidenced by: Based on a pre-survey review of the Certification and Survey Provider Enhanced Reporting (CASPER) 0155 report, Proficiency Testing (PT) records, and interview, the laboratory failed to attain a score of at least 80% for the analyte Potassium (K) on two (2) consecutive chemistry module testing events resulting in an initial unsuccessful PT performance. The findings include: 1. A pre-survey review of the CMS 0155 report revealed the laboratory received unsatisfactory scores for the regulated analyte #0465, K, of 0% in the 2025 Chemistry-2nd Event and a score of 60% in the 2025 Chemistry-3rd Event. 2. Review of the laboratory's American Proficiency Institute (API) PT evaluations revealed K scores of less than 80% for the following 2 consecutive chemistry PT events: API 2025 Chemistry Event 2: K scored 0% ; API 2025 Chemistry Event 3: K scored 60%; resulting in an initial unsuccessful PT performance. 3. In an email interview with the Technical Consultant on February 11, 2026 at 12:56 PM, the above findings were confirmed. 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 a review of the Certification and Survey Provider Enhanced Reporting (CASPER) 0155 report, proficiency testing records, and interview, the laboratory director failed to provide overall direction and management 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 a review of the Certification and Survey Provider Enhanced Reporting (CASPER) 0155 report, proficiency testing (PT) records, and interview, the laboratory director (LD) failed to ensure the overall quality of the laboratory services provided. -- 2 of 3 -- The LD failed to ensure successful participation in the laboratory's Health and Human Services (HHS) approved PT program. Refer to D2088. -- 3 of 3 --

Summary Statement of Deficiencies D0000 An announced CLIA Recertification survey was conducted at the Women's Cancer & Wellness Institute on 05/23/22 by the Virginia Department of Health's Office of Licensure and Certification. The laboratory was surveyed under 42 CFR part 493 CLIA Requirements. Specific deficiencies cited are as follows: The laboratory is performing COVID-19 testing and is in compliance with the applicable COVID-19 reporting requirements. 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 a tour of the lab, review of quality control (QC) records, calibration verification records, lack of documentation and interviews, the lab failed to verify the accuracy, precision, and reportable range of the new Abaxis Piccolo chemistry analyzer installed on 07/27/21 prior to testing patients and reporting approximately 4,200 patients from 07/27/21 up to date of survey on 05/23/22. Findings include: 1. During a tour of the lab testing area on 05/23/22 at approximately 12:30 PM, the surveyor observed one Abaxis Piccolo chemistry analyzer, serial number P26743. In an interview with the technical consultant during the tour, they stated that the chemistry analyzer was replaced in July 2021. 2. A review of QC and calibration verification records, and an interview with the technical consultant on 05/23/22 at approximately 1500 revealed that the lab received the new Abaxis piccolo chemistry 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 -- analyzer, serial number P26743, as a loaner instrument on 07/27/21 while the previous analyzer was returned to the manufacturer for repairs (Serial number P25744). The lab kept the loaner instrument as their primary instrument. The QC records revealed the lab assayed two levels of QC materials on 07/27/21 twice and three times on 07/28 /21. The lab performed a calibration verification procedure on 08/21/21. 3. The surveyor requested to review the initial performance specification documents for the loaner instrument introduced for patient testing on 07/21/21. The documents were not available for review. 4. Review of daily patient testing records revealed that approximately 4,200 patients assayed and reported from 07/27/21 up to the date of survey on 05/23/22. 5. An exit interview with the technical consultant at approximately 1600 on 05/23/22 confirmed the findings. D6055 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) The technical consultant is responsible for evaluating and documenting the performance of individuals responsible for moderate complexity testing whenever test methodology or instrumentation changes. The individual's performance must be reevaluated to include the use of the new test methodology or instrumentation prior to reporting patient test results. This STANDARD is not met as evidenced by: Based on the review of the Laboratory Personnel Report Form (CLIA) (CMS-209 Form), initial performance specification records, testing personnel (TP) records, lack of documentation, and interview, the technical consultant failed to provide documentation of the training and evaluation of training of four of four TP for the new hematology analyzer initiated for patient testing on 01/13/22. Findings include: 1. Review of the CLIA CMS-209 Form revealed four TP performing patient testing. 2. Review of the initial performance specifications records for the New DxH 500 hematology analyzer (SN S460011041R78T) revealed initiation for patient testing on 01/13/22. 3. Review of four TP records revealed lack of documentation of training and evaluation of training for the new DxH 500 hematology analyzer prior to patient testing on 01/13/22. The surveyor requested the aforementioned documents. The documents were not available for review at the date of survey on 05/23/22. 4. An exit interview with the technical consultant at approximately 1600 on 05/23/22 confirmed the findings. -- 2 of 2 --