River Valley Obstetrics And Gynecology

Summary Statement of Deficiencies D2014 TESTING OF PROFICIENCY TESTING SAMPLES (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 upon a review of proficiency test documentation for 2024 and 2025, lack of documentation, and interview with laboratory staff, the laboratory failed to maintain copies of proficiency test instrument data for six of six proficiency test events surveyed. Survey findings follow: A) Review of proficiency testing documentation for API Microbiology 2024 event 1, API Microbiology 2024 event 2, API Microbiology 2024 event 3, API Microbiology 2025 event 1, API Microbiology 2025 event 2, API Microbiology 2025 event 3, revealed that original instrument result data was not included in the documentation. B) Upon request, the laboratory was unable to produce the instrument data for the events identified above. C) In an interview on 5/13/26 at 10:55 a.m., the laboratory staff member #4, as identified on the CMS 209 form, confirmed that the instrument data for the events identified above was not available. D5311 SPECIMEN SUBMISSION, HANDLING, AND REFERRAL CFR(s): 493.1242(a) (a) The laboratory must establish and follow written policies and procedures for each of the following, if applicable: (a)(1) Patient preparation. (a)(2) Specimen collection. (a)(3) Specimen labeling, including patient name or unique patient identifier and, 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 -- when appropriate, specimen source. (a)(4) Specimen storage and preservation. (a)(5) Conditions for specimen transportation. (a)(6) Specimen processing. (a)(7) Specimen acceptability and rejection. (a)(8) Specimen referral. This STANDARD is not met as evidenced by: Based upon a review of laboratory policy and procedure, observation, and interview the laboratory failed to label one of six specimen collection containers with patient name and unique patient identifier. Findings follow: A) During a tour of the laboratory on 5/13/26 at 12:02 p.m. one urine specimen container was observed in the laboratory testing area labeled with a patient's last name and first initial only.. B) Review of the laboratory policy and procedure revealed that "patient specimen containers must be labeled with the patient's name and unique identifier". . C) In an interview on 5/13/26 at 12:05 p..m. , the laboratory staff member (#4 on the CMS 209 form) confirmed that the specimen identified above had been analyzed and lacked proper patient identification on the containers as required by policy and procedure. D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) (b) The procedure manual must include the following when applicable to the test procedure: (b)(1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (b)(2) Microscopic examination, including the detection of inadequately prepared slides. (b)(3) Step-by- step performance of the procedure, including test calculations and interpretation of results. (b)(4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (b)(5) Calibration and calibration verification procedures. (b)(6) The reportable range for test results for the test system as established or verified in 493.1253. (b)(7) Control procedures. (b)(8)

Summary Statement of Deficiencies 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 review of proficiency test documentation and interviews with laboratory staff, the testing personnel failed to sign proficiency testing attestation statements for four of five testing events in 2023 and 2024. Survey findings include: A. A review of proficiency testing documentation from 2023 and 2024 showed the testing personnel failed to sign the attestation statement for the First Testing Event of 2023, Third Testing Event of 2023, First Testing Event of 2024, and Second Testing Event of 2024. B. In an interview, at 10:46 a.m. on 8/21/24, the technical supervisor (as listed on the form CMS-209) confirmed the attestation statements listed above had not been signed by the testing personnel. 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 --

Summary Statement of Deficiencies D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) The laboratory must define criteria for those conditions that are essential for proper storage of reagents and specimens, accurate and reliable test system operation, and test result reporting. The criteria must be consistent with the manufacturer's instructions, if provided. These conditions must be monitored and documented and, if applicable, include the following: (1) Water quality. (2) Temperature. (3) Humidity. (4) Protection of equipment and instruments from fluctuations and interruptions in electrical current that adversely affect patient test results and test reports. This STANDARD is not met as evidenced by: Through review of the manufacturer's user manual for the BD Max microbiology instrument, lack of documentation and interview it was determined that the laboratory failed to monitor the humidity level required for the operation of the BD Max microbiology system. Findings follow: A) Review of the manufacturer's user manual for the BD Max microbiology instrument revealed an operating humidity requirement of 20% to 80%. B) Review of the environmental records of the laboratory room in which the BD Max microbiology systems is used contained no records of the room humidity level. C) In an interview on 10/14/22 at 11:37 am, the laboratory staff member (#4 on the CMS 209 form) confirmed that the humidity level in the room in which the BD Max system was used had not been monitored. 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 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 -- 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. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Through review of the Individualized Quality Control Plan (IQCP) for the BD Max microbiology system and interview with laboratory staff it was determined that the IQCP plan for the BD Max system lacked the specific identification of the external quality control material used. Findings follow: A) Review of the "BD Max IQCP" revealed that "External quality control containing a positive and negative control will be analyzed with each new lot number of reagents or at least once a month" but the identification of the control material was not specified. B) In an interview on 10/14/22 at 12:12 pm, the laboratory staff member (#4 on the CMS 209 form) confirmed that the IQCP, identified above, lacked the specific identity of the QC material to be used. 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: Through review of the Individualized Quality Control Plan (IQCP) for the BD Max microbiology system, review of QC results from March 2022, lack of documentation and interview with laboratory staff it was determined that the laboratory failed to run negative QC material when performing monthly QC. Findings follow: A) Review of the IQCP for the BD Max microbiology system revealed that positive and negative external control material is to be performed "at least monthly". B) Review of the QC results from March 2022 to the date of survey revealed positive external control results for each month reviewed but no negative results were presented. C) Upon request, the laboratory was unable to provide monthly negative external QC results for each month since March 2022. D) In an interview on 10/14/22 at 12:12 pm, the laboratory staff member (#4 on the CMS 209 form) stated that no negative external control was performed from March 2022, when testing was begun, until the date of the survey. D5805 TEST REPORT CFR(s): 493.1291(c) The test report must indicate the following: (c)(1) For positive patient identification, either the patient's name and identification number, or a unique patient identifier and identification number. (c)(2) The name and address of the laboratory location where the test was performed. (c)(3) The test report date. (c)(4) The test performed. (c)(5) Specimen source, when appropriate. (c)(6) The test result and, if applicable, the units of measurement or interpretation, or both. (c)(7) Any information regarding the condition and disposition of specimens that do not meet the laboratory's criteria for acceptability. -- 2 of 3 -- This STANDARD is not met as evidenced by: Through a review of randomly selected medical records, lack of documentation, and interviews with staff, it was determined test reports failed to include the date of collection and source of the specimen submitted. Survey findings follow: A) The surveyor reviewed test reports from randomly selected medical records of patients who had tests performed in the laboratory . . B) In an interview, at 12:15 pm on 10/14 /22, employee #4 (as listed on the CMS 209 form) confirmed the lack of date of collection and specimen source on all records reviewed. -- 3 of 3 --