Shaw Center For Women's Health

Summary Statement of Deficiencies D0000 A Clinical Laboratory Improvement Amendments (CLIA) recertification survey was completed on August 04, 2026 . The laboratory was not in compliance with applicable CLIA requirements found at 42 CFR 493.1 through 42 CFR 493.1780. The following deficiencies were cited: 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 review of the American Association of Bioanalyst (AAB) profiency test (PT) records and interview with the testing personnel, the laboratory director failed to attest that PT samples were tested in the same manner as patient specimens. Findings: 1.A review of PT documents revealed the laboratory director failed to sign attestations for PT events 2025 M3 Vaginosis Screen and Serum Pregnancy test. 2. A Review of PT documents revealed the laboratory director failed to sign attestations for PT events 2026 M1 and M2 Serum Pregnanacy test and Vaginosis Screen. 3.An interview with testing personnel # 1 (CMS 209) confirmed the aforementioned findings on 8/04/2026 at 3:00 pm in the conference room. D3011 FACILITIES CFR(s): 493.1101(d) Safety procedures must be established, accessible, and observed to ensure protection from physical, chemical, biochemical, and electrical hazards, and biohazardous materials. 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 -- This STANDARD is not met as evidenced by: Based on observation during the laboratory tour, review of the Standard Operating Procedures, and interview with the Clinical Team Lead, the laboratory director failed to ensure that safety procedures were established, accessible, and observed. Findings: 1. A review of maintenance logs revealed the maintenance was not performed on 3 of 3 eye wash stations for the years 2024 and 2025. 2. During an interview with the testing personnel # 1(CMS 209) in the conference room on August 04, 2026 at 3:00 p. m., confirmed aforemention finding. D6032 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(14) (e)(14) Specify, in writing, the responsibilities and duties of each consultant and each person, engaged in the performance of the preanalytic, analytic, and postanalytic phases of testing, that identifies which examinations and procedures each individual is authorized to perform, whether supervision is required for specimen processing, test performance or results reporting, and whether consultant or director review is required prior to reporting patient test results. This STANDARD is not met as evidenced by: Based on review of the laboratory policy and procedure manual (SOP) and staff interview, the laboratory director (LD) failed to specify, in writing the duties and responsibilities of each person engaged in the performance of the preanalytic, analytic, and postanalytic phases of laboratory testing. Findings include: 1. An SOP review revealed the LD failed to specify in writing the duties and responsibilities of the laboratory director, technical consultant, clinical consultant, and the testing personnel. 2. An interview with testing personnel # 1 (CMS 209) in the conference room on 8/04/2026 at 3:00 pm confirmed the SOP did not contain duties and responsibilities for the positions indicated above. -- 2 of 2 --

Summary Statement of Deficiencies D0000 A Clinical Laboratory Improvement Amendments (CLIA) Recertification survey was completed on November 19, 2020. The laboratory was not in compliance with applicable CLIA requirements found at 42 CFR 493.1 through 42 CFR 493.1780. The following deficiencies were cited: D5200 GENERAL LABORATORY SYSTEMS CFR(s): 493.1230 Each laboratory that performs nonwaived testing must meet the applicable general laboratory systems requirements in 493.1231 through 493.1236, 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 general laboratory systems and correct identified problems specified in 493.1239 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: Based on review of the Quality Control for the Serum hCG Test, and the Affirm VPIII Test, the laboratory failed to perform QC for each new lot number, or every 30 days, which ever comes first, according to their written Individualized Quality Control Procedure. Reference: D5441 D5441 CONTROL PROCEDURES CFR(s): 493.1256(a)(b)(c)(g) (a) For each test system, the laboratory is responsible for having control procedures that monitor the accuracy and precision of the complete analytic process. (b) The laboratory must establish the number, type, and frequency of testing control materials using, if applicable, the performance specifications verified or established by the laboratory as specified in 493.1253(b)(3). (c) The control procedures must-- (c)(1) Detect immediate errors that occur due to test system failure, adverse environmental 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 -- conditions, and operator performance. (c)(2) Monitor over time the accuracy and precision of test performance that may be influenced by changes in test system performance and environmental conditions, and variance in operator performance. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on the review of the Quality Control (QC) Procedure and Individual Quality Control Procedure (IQCP) and QC Logs for Serum hCG, and Affirm VP III , the laboratory failed to perform QC as described in their IQCP. Findings: 1. Review of the Affirm VPIII QC log, and the IQCP for the Affirm, indicated that not all lot numbers and expiration dates was being documented on the QC log. Without the documentation of the lot numbers and expiration, the laboratory did not document that the different kit lots were being tested every 30 days or with each new lot number, which ever came first. From 12/6/2018 to 11/29/2020 - there was 14 entries that did not have the kit expiration listed. there was 12 entries that did not have the QC expiration listed there was two date entries that did not have any QC results documented there was three dates that had gaps of two to three months that did not have documented QC 2. Review of the Serum hCG quality control log, and the IQCP for the Serum hCG, indicated that not all lot numbers and expiration dates was being documented on the QC log. There was gaps of greater than 30 days between documented lot numbers, and expiration dates. From 08/14/2018 to 10/2/2020 - there was only 11 entries for Serum hCG QC there was one entry that did not have the hCG kit lot and expiration dated there was gaps between the documented QC for the hCG from 1 month to up to 5 months with no documentation of QC being performed. 3. Interview with staff #2 (CMS 209 form), on November 19, 202 at approximately 1pm, in an office, confirmed that the aforementioned dates and gaps in the Affirm VPIII QC log, and the Serum hCG QC log was correct. -- 2 of 2 --

Summary Statement of Deficiencies D0000 A Clinical Laboratory Improvement Amendments (CLIA) recertification survey was completed on June 27, 2018. The laboratory was not in compliance with all applicable CLIA requirements found at 42 CFR 493.1 through 42 CFR 493.1780. The following deficiencies were cited: D5447 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(i)(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-- At least once a day patient specimens are assayed or examined perform the following for-- Each quantitative procedure, include two control materials of different concentrations; (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on review of the Quality Control (QC) documents for the AFFIRM ( testing for Candida species, Gardnerella, and Trichomonas), and the Serum Human Chorionic Gonadotropin (HCG), and staff interview, the Laboratory was not performing two levels of Controls each day of patient testing. Findings: 1. Review of the QC documents for the AFFIRM and the Qualitative Serum HCG test, the laboratory was only performing QC monthly and at the time of lot number change for the AFFIRM and Qualitative Serum HCG test. 2. Interview with staff #2 (CMS form 209), on June 27, 2018 at approximately 11 am, in the doctor's office, confirmed that they were only performing monthly QC and when a new lot number came in, on the AFFIRM and the Qualitative Serum HCG test. 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 --