Associates In Women's Health

Summary Statement of Deficiencies D5449 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(ii)(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 qualitative procedure, include a negative and positive control material; (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on record review and an interview with the sole Testing Personnel (TP), the laboratory failed to perform and document a negative quality control (QC) for the Neisseria Gonorrhea (NG) and Chlamydia Trachomatis (CT) tests on the Cepheid GeneXpert after the manufacturer performed a preventive maintenance (PM) procedure on 03/25/2022. This deficient practice had the potential to affect 1861 out of 1861 patient tests performed between 03/25/2022 through 04/20/2023. Findings Include: 1. Review of the laboratory's "Associates in Women's Health of the Mahoning Valley, Inc. Policy and Procedure Manual", provided on the date of the inspection and approved via signature and date by the Laboratory Director on 03/29 /2018, did not find any instructions for conducting QC after Cepheid GeneXpert analyzer preventive maintenance (PM) procedures conducted by the manufacturer. 2. Review of the laboratory's 2021, 2022 and 2023 QC records and manufacturer's preventative maintenance records did not find any documentation that the laboratory conducted a negative QC on 03/25/2022 for NG and CT after the Cepheid GeneXpert manufacturer returned the Cepheid GeneXpert analyzer back to the laboratory for patient testing. 3. The Inspector requested the laboratory's QC documentation conducted post manufacturer's services and preventative maintenance procedures from the sole TP. The sole TP confirmed on 10/27/2023 via electronic mail at 12:07 PM 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 -- that the laboratory failed to conduct a negative QC for NG and CT after the manufacturer's service and preventative maintenance procedure on 03/25/2022 and was unable to provide the requested documentation. D6053 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 at least semiannually during the first year the individual tests patient specimens. This STANDARD is not met as evidenced by: Based on record review and an interview with the sole Testing Personnel (TP), the TC failed to evaluate and document the first semi-annual competency of the sole TP who were responsible for moderate complexity Neisseria Gonorrhea (NG) and Chlamydia Trachomatis (CT) testing procedures during the first year the individual tested patient specimens. This deficient practice had the potential to affect 2931 out of 2931 patient tests performed by the sole TP between 10/07/2021 through 10/07/2022. Findings Include: 1. Review of the laboratory's Form CMS-209, provided on the date of the inspection, approved, signed and dated by the Laboratory Director on 10/02/2023, revealed one individual qualified and listed as TP. 2. Review of the laboratory's "Testing Employee Competency Assessment" policy and procedure, provided on the date of the inspection, approved, signed and dated by the Laboratory Director on 03/29 /2018, found the following statement: "The testing employee competency assessment is required at least semi-annually in the first year and annually thereafter." 3. Review of the laboratory's 2021, 2022 and 2023 competency assessment records, provided for the inspection, did not find any record of the first semi-annual competency assessment during the sole TP's first year of NG and CT testing on patient specimens. The sole TP's initial training and demonstration of competency was completed on 10/07/2021 and their second semiannual assessment was completed on 10/07/2022. 4. The Inspector requested the laboratory's first semiannual competency assessment records for the sole TP from the sole TP. The sole TP confirmed the TC did not assess their first semiannual competency during their first year of testing patient specimens according to the laboratory's policy and procedure and was unable to provide the requested documentation on the date of the inspection. The interview occurred on 10 /18/2023 at 8:26 AM. -- 2 of 2 --

Summary Statement of Deficiencies D5301 TEST REQUEST CFR(s): 493.1241(a) The laboratory must have a written or electronic request for patient testing from an authorized person. This STANDARD is not met as evidenced by: Based on record review and interviews with the Technical Consultant (TC) and testing personnel (TP) #1, the laboratory failed to have written or electronic test requests /orders from an authorized person for one out of 10 Chlamydia Trachomatis (CT) and Neisseria Gonorrhoeae (NG) tests run on the Cepheid Gene Xpert instrument and one out of 10 Trichomonas Vaginalis (trichomonas), Gardnerella Vaginalis (Gardnerella) and Candida tests run on the BD Affirm VPIII instrument. All patient testing for the above mentioned analytes had the potential to be affected by this deficient practice. Findings Include: 1. Review of 10 patient test records and test reports, provided on the date of the inspection, revealed one patient report with a CT/NG result, however did not find any written or electronic test request/order for the CT/NG tests performed, as indicated below: Date/Time Specimen Collected 03/08/2018 at 3:50 PM 2. Review of 10 patient test records and test reports, provided on the date of the inspection, revealed one patient report with Trichomonas, Gardnerella and Candida results, however did not find any written or electronic test request/order for the Trichomonas, Gardnerella and Candida tests performed, as indicated below: Date/Time Specimen Collected 10 /08/2018 at 2 PM 3. The inspector requested the laboratory's test requisition/order from an authorized individual for the patient CT/NG tests performed on 03/08/2018 at 3:50 PM and for the patient Trichomonas, Gardnerella and Candida tests performed on 10/08/2018 at 2 PM from the TC and TP#1. The TC and TP#1 confirmed the progress notes in the paper charts for the patients indicated above did not include orders for the corresponding tests performed and were unable to provide the requested documentation on the date of the inspection at 12:55 PM. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 4 -- D5313 SPECIMEN SUBMISSION, HANDLING, AND REFERRAL CFR(s): 493.1242(b) The laboratory must document the date and time it receives a specimen. This STANDARD is not met as evidenced by: Based on record review and interviews with the Technical Consultant (TC) and testing personnel (TP) #1, the laboratory failed to document the date and time in which the Trichomonas Vaginalis (Trichomonas), Gardnerella Vaginalis (Gardnerella) and Candida specimens were received in the laboratory, specimens prepared, tested and reported. All patients tested on the BD Affirm instruments from 09/18/2017 to 08/21 /2019 had the potential to be affected by this deficient practice. Findings Include: 1. Review of the BD Affirm manufacturer's instructions revealed the following statement under "Specimen Storage and Transport": "When using the Affirm VPIII Ambient Temperature Transport System (ATTS): The total time between sample collection and proceeding with sample preparation should be no longer than 72 h when the sample is stored at ambient conditions (15-30C). When using either the Affirm VPIII Sample Collection Set or the swabs contained in the Affirm VPIII Microbial Identification Test Kit: The total time between placing the swab into the sample collection tube and proceeding with the sample preparation should be no more than 1 h if the sample is stored at room temperature, or 4 h if the sample is stored at 2- 8C." 2. Review of 10 out of 10 of the laboratory's patient test records and final "Laboratory Report" for the BD Affirm testing, as listed below, did not find the time the laboratory received the specimens or the time the specimens were prepared, tested and reported. Collection Dates as indicated on the "Laboratory Report" 03/08/18 4/19 /19 09/20/18 5/28/19 10/08/18 6/11/19 10/08/18 6/13/19 11/03/18 12/04/18 3. The Inspector requested the laboratory's documentation of the above listed 10 patient BD Affirm specimens for the time they were received in the laboratory, time prepared, time tested and time reported from the TC and TP#1. The TC and TP#1 stated the laboratory did not document specimen receipt time in the laboratory, preparation time, time tested and time reported and were unable to provide the requested documentation on the date of the inspection. The interviews occurred on 08/21/2019 at 11:30 AM. D5481 CONTROL PROCEDURES CFR(s): 493.1256(f)(g) (f) Results of control materials must meet the laboratory's and, as applicable, the manufacturer's 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: Based on record review and interviews with the Technical Consultant (TC) and testing personnel (TP) #1, the laboratory failed to meet the criteria of acceptability for the Trichomonas Vaginalis (Trichomonas), Gardnerella Vaginalis (Gardnerella) and Candida quality control (QC) results run on the BD Affirm VPIII instruments "A" and "B" before reporting patient test results. 77 out of 77 patients tested on instrument "A" and 40 out of 40 patients tested on instrument "B" for Trichomonas, Gardnerella and Candida between 05/08/2019 and 06/05/2019 had the potential to be affected by this deficient practice. Findings Include: 1. Review of the laboratory's Individualized Quality Control Plan (IQCP) revealed the laboratory performed external positive and negative controls on each of the BD Affirm analyzers each week, each newly opened -- 2 of 4 -- kit, each new lot number, each shipment, each new untrained operator and if any test results are questionable. 2. Review of the laboratory's "Associates in Women's Health of the Mahoning Valley, Inc. Policy & Procedure Manual", approved, signed/dated by the Laboratory Director on 03/21/18 and provided on the date of the inspection, found a section titled "Quality Control (QC)" on pages 47 and 48 of the manual that included the following: "QC