Vernon Memorial Hospital Inc

Summary Statement of Deficiencies D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on surveyor review of the Centers for Medicare and Medicaid Services (CMS) Laboratory Personnel Report (Form CMS-209), personnel records, and laboratory procedures, and interview with the Technical Supervisor (Staff A), the laboratory did not establish procedures for evaluation of two of two staff members with delegated technical consultant, technical supervisor, or general supervisor responsibilities. Finding include: 1. Review of the Form CMS-209 the laboratory provided for this survey showed the Laboratory Director delegated technical consultant, technical supervisor and general supervisor responsibilities to Staff A and technical supervisor responsibilities to Staff B. 2. Review of personnel records showed no competence evaluation of the technical consultant, technical supervisor, or general supervisor responsibilities for Staff A and B. 3. Review of the laboratory procedure, "CLIA Delegation for Competency and Proficiency Attestation", effective September 30, 2024, showed no requirement for evaluation of the technical consultant, technical supervisor, and general supervisor responsibilities. 4. Interview with Staff A on November 13, 2025, at 3:20 PM confirmed the laboratory had not established procedures to assess the technical consultant, technical supervisor, and general supervisor competence and had not defined the frequency of evaluation for these positions. D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 5 -- At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: Based on surveyor review of proficiency testing (PT) records and interview with the Technical Consultant (Staff A), the laboratory did not verify the accuracy of sperm motility tests twice annually in two of the last two years. Findings include: 1. Review of PT records from 2024 and 2025 showed no evidence the laboratory enrolled in PT for sperm motility evaluation. Printed test reports from the electronic medical record included with the PT records showed the laboratory reports an evaluation of sperm motility with their post-vasectomy semen analysis test. 2. Interview with Staff A on November 13, 2025, at 3:40 PM confirmed testing personnel report sperm motility as part of the post-vasectomy semen analysis procedure and confirmed the laboratory had not enrolled in a PT program to verify the accuracy of sperm motility evaluations. Further interview confirmed the laboratory did not utilize another method to verify the accuracy of this test twice annually. This is a repeat deficiency, D5217 was previously cited on December 16, 2021. 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 D3031 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3) Analytic systems records. Retain quality control and patient test records (including instrument printouts, if applicable) and records documenting all analytic systems activities specified in 493.1252 through 493.1289 for at least 2 years. This STANDARD is not met as evidenced by: Item 1 Based on surveyor review of laboratory records and interview with a technical consultant and hematology lead, staff A and staff B, the laboratory did not retain the lot and expiration date for the wash solution on the Mini-iSED for five of five months reviewed in 2023. Findings include: 1. Review of the Mini-iSed quality control log showed no documentation of wash solution lot or expiration date information from May 23, 2023, through November 9, 2023. 2. Interview with the staff A and staff B on November 9, 2023, at 12:40 PM confirmed the laboratory did not retain the lot and expiration dates from the Mini-iSED analyzer. Item 2 Based on surveyor review of laboratory records and interview with the a technical consultant, staff C, the laboratory did not retain the lot and expiration date for the quality control used on the Cepheid Gene Xpert analyzer for four of seven analytes performed on the analyzer. Findings include: 1. Review of the quality control on the Cepheid Gene Xpert showed no documentation of quality control lot or expiration date information in 2022 and 2023. 2. Interview with the staff C on November 8, 2023, at 1:45 PM stated three of the seven analytes used quality control material from plated cultures and the other four analytes used commercial quality control material. Further interview confirmed the laboratory did not retain the lot and expiration dates for the commercial quality control material. D5221 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(d) 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 -- All proficiency testing evaluation and verification activities must be documented. This STANDARD is not met as evidenced by: Based on surveyor review of American Proficiency Institute (API) proficiency testing (PT) records and email interview with a technical consultant, staff A, the laboratory failed to document

Summary Statement of Deficiencies D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: Based on surveyor review of proficiency testing (PT) and quality assurance records and interview with a technical consultant, the laboratory had not verified the accuracy of the ROM (Rupture of Membranes) Plus assay during 2020 or 2021. Findings include: 1. Review of PT records showed no evidence of enrollment in a proficiency testing program for the ROM Plus assay in 2020 or 2021. 2. Review of other quality assurance records showed no evidence of twice annual accuracy verification for the ROM Plus assay in 2020 or 2021. 3. Interview with the technical consultant (staff A) on December 16, 2021 at 1:15 PM confirmed the laboratory had not verified the accuracy of the ROM Plus assay twice annually in 2020 or 2021. This is a repeat deficiency cited on August 9, 2013. D5409 PROCEDURE MANUAL CFR(s): 493.1251(e) The laboratory must maintain a copy of each procedure with the dates of initial use and discontinuance as described in 493.1105(a)(2). This STANDARD is not met as evidenced by: Based on surveyor review of IQCP (Individualized Quality Control Plans) and interview with a technical consultant, the laboratory has not identified the discontinuance date with the IQCPs for five of five test systems with discontinued plans. Findings include: 1. Review of the laboratory's IQCP manual showed the Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 6 -- manual included IQCPs for the following five test systems: RSV Binax Now Syphilis Health Check, two copies Illumigene Strep A, B and Bordetella Alere Determine HIV 1/2 Ag/Ab Combo iSTAT Lactate Review of the plans showed no indication the plans were not in use. 2. Interview with a technical consultant (staff A) on December 16, 2021 at 9:15 AM confirmed the laboratory discontinued the five test systems on the following dates: RSV Binax Now / August 28, 2019 Syphilis Health Check / October 15, 2019 Illumigene Strep A, B / July 19, 2019 Bordetella / November 23, 2021 Alere Determine HIV 1/2 Ag/Ab Combo / December 9, 2019 iSTAT Lactate / January 17, 2020 Further interview confirmed the laboratory did not identify the IQCPs as discontinued and did not include the date of discontinuance with the plans. D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document maintenance as defined by the manufacturer and with at least the frequency specified by the manufacturer. This STANDARD is not met as evidenced by: Based on surveyor review of maintenance records and interview with the technical consultant, maintenance of the Cobas ISE (Ion Selective Electrode) measuring cartridge was not completed every two months as required for the Cobas 501 and 6000 analyzers. During 2020 and 2021 the laboratory did not perform maintenance timely three of twelve times on the Cobas 501 and six of twelve times on the Cobas 6000. Findings include: 1. Review of the maintenance logs for the Cobas 501 showed maintenance was due on the ISE measuring cartridge every two months. The records showed the laboratory performed maintenance in 2020 in Jan, March, May, July, October, and December and in 2021 in March, May, August, and October. The two- month maintenance was due but not documented in September 2020 and February and July 2021. Review of the maintenance logs for the Cobas 6000 showed maintenance was due on the ISE measuring cartridge every two months. The records showed the laboratory performed maintenance in 2020 in March, May, August, November and December and in 2021 in March, June, August, and November. The two-month maintenance was due but not documented in January, July, and October 2020 and February, May, and October 2021. 2. Interview with a technical consultant (staff A) on December 16, 2021 at 3:00 PM confirmed the laboratory did not document performance of the maintenance every two months on the Cobas 510 and 6000 analyzers. This is a repeat deficiency previously cited on November 14, 2019 and November 12, 2015. D5439 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(b) Unless otherwise specified in this subpart, for each applicable test system the laboratory must do the following: Perform and document calibration verification procedure - (b)(1) Following the manufacturer's calibration verification instructions; (b)(2) Using the criteria verified or established by the laboratory under 493.1253(b)(3) -- (b)(2)(i) Including the number, type, and concentration of the materials, as well as acceptable limits for calibration verification; and (b)(2)(ii) Including at least a minimal (or zero) value, a mid-point value, and a maximum value near the upper limit of the range to verify the laboratory's reportable range of test results for the test system; and (b)(3) At least once every 6 months and whenever any of the following -- 2 of 6 -- occur: (b)(3)(i) A complete change of reagents for a procedure is introduced, unless the laboratory can demonstrate that changing reagent lot numbers does not affect the range used to report patient test results, and control values are not adversely affected by reagent lot number changes. (b)(3)(ii) There is major preventive maintenance or replacement of critical parts that may influence test performance. (b)(3)(iii) Control materials reflect an unusual trend or shift, or are outside of the laboratory's acceptable limits, and other means of assessing and correcting unacceptable control values fail to identify and correct the problem. (b)(3)(iv) The laboratory's established schedule for verifying the reportable range for patient test results requires more frequent calibration verification. This STANDARD is not met as evidenced by: Based on surveyor review of calibration verification records and interview with a technical consultant, the laboratory did not perform one of the last four calibration verification events for testing performed on the Cobas 501 and 6000 analyzers. Findings include: 1. Review of calibration verification records for 2020 and 2021 revealed records for calibration verification testing performed in April and November 2020 and November 2021 for the Cobas 501 and 6000 analyzers. No records for either analyzer were available from April 2021. 2. Interview with the technical consultant (staff A) on December 16, 2021 at 2:00 PM confirmed the laboratory did not complete calibration verification in April 2021 for testing on the Cobas 501 or 6000 analyzers. 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 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 surveyor review of Individualized Quality Control Plan (IQCP) documents and interview with a general supervisor, the IQCP for the XPect Giardia and Cryptosporidium test kit did not define the required quality control (QC) type for external control testing or specify the required frequency of testing. Findings include: 1. Review of the laboratory's IQCP for the XPect Giardia and Cryptosporidium test kit revealed the following two statements regarding external control testing in this laboratory: "Reagents are shipped refrigerated and before use, the Kit is tested with positive and negative controls." "We suggest QC be run monthly with concomitant Proficiency Testing each year to insure the accuracy of the test." 2. Interview with the general supervisor (staff A) confirmed the IQCP did not specify the required type of external control or the required frequency for testing the control materials. Further interview revealed the test procedure required monthly testing of external controls in addition to testing new shipments of test kits. -- 3 of 6 -- 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 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 surveyor review of SARS CoV-2 testing records, proficiency testing reports, Individualized Quality Control Plans (IQCP) and interview with a technical consultant, the laboratory did not develop an IQCP for equivalent quality testing for the SARS CoV-2 test performed since June 4, 2020 and has not performed controls each day of testing to meet the regulatory requirements for quality control testing. Findings include: 1. Review of SARS CoV-2 testing records showed the laboratory performed the testing on the Cepheid XPert analyzer. 2. Review of proficiency testing reports showed the laboratory enrolled and reports the SARS CoV-2 results as a non- waived test. 3. Review of the IQCP manual showed no evidence of an IQCP for the individual SARS CoV-2 assay. 4. Interview with a technical consultant (staff A) on December 16, 2021 at 10:00 AM confirmed the laboratory used the Cepheid SARS CoV-2 test system as a non-waived test since June 4, 2020. Further interview confirmed the laboratory did not develop an IQCP for the individual SARS CoV-2 test and did not test external controls each day of patient testing to meet the regulatory requirements. D5793 ANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1289(b)(c) (b) The analytic systems quality assessment must include a review of the effectiveness of

Summary Statement of Deficiencies D5411 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(a) Test systems must be selected by the laboratory. The testing must be performed following the manufacturer's instructions and in a manner that provides test results within the laboratory's stated performance specifications for each test system as determined under 493.1253. This STANDARD is not met as evidenced by: Based on surveyor review of laboratory records, observation of test equipment, and interview with the technical consultant, the laboratory did not verify the patient normal prothrombin time was accurately entered into the coagulation analyzer for the current lot of RecombiPlasTin reagent that was in use. Findings include: 1. Review of laboratory records showed the laboratory started using the current lot number of RecombiPlasTin 2G reagent August 17, 2018. Further review shows the lab determined the patient normal prothrombin time for this lot number was 11.5 seconds. 2. Observation of the Instrumentation Laboratory ACL TOP 300 coagulation analyzer Materials Setup menu on November 14, 2019 at 10:15 AM shows the patient normal prothrombin time in the analyzer was set at 11.8 seconds. The patient normal prothrombin time is used with the RecombiPlasTin 2G International Sensitivity Index (ISI) to calculate the patient International Normalized Ratio (INR). Patient INR results are reported in the laboratory. 3. Interview with technical consultant A on November 14, 2019 at 10:15 AM confirmed the patient normal prothrombin time entered into the coagulation analyzer and used to calculate patient INR results was not correct. This deficiency (D5411) was previously cited on October 16, 2007, February 9, 2010, October 12, 2011, August 9, 2013, November 12, 2015, and November 9, 2017. D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) 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 -- For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document maintenance as defined by the manufacturer and with at least the frequency specified by the manufacturer. This STANDARD is not met as evidenced by: Based on surveyor review of chemistry maintenance logs and interview with the technical consultant, the laboratory has not performed maintenance on the Cobas 6000 and 501 chemistry analyzers as required. Findings include: 1. Review of the Cobas chemistry maintenance logs "501 Yearly Maintenance Log" and "6000 Yearly Maintenance Log" shows the bimonthly, trimonthly, and every six month maintenance was not performed at the required frequency: Cobas 6000 Analyzer: Bimonthly maintenance performed: April 22, 2019 July 25, 2019 Trimonthly maintenance performed: February 22, 2019 July 25, 2019 Next trimonthly maintenance was due October 2019 and as of the survey date on November 14, 2019 it was not performed. Every six month maintenance performed: April 22, 2019 Next six month maintenance was due October 2019 and as of the survey date on November 14, 2019 it was not performed. Cobas 501 Analyzer Bimonthly maintenance performed: March 12, 2019 July 16, 2019 Trimonthly maintenance performed: March 12, 2019 July 16, 2019 Every six month maintenance performed: October 9, 2018 July 16, 2019 2. Interview with technical consultant A on November 14, 2019 at 1:30 PM confirmed maintenance had not been performed at the required frequency on the Cobas 6000 and 501 chemistry analyzers. This deficiency was previously cited on November 12, 2015. D5477 CONTROL PROCEDURES CFR(s): 493.1256(e)(4)(g) (e) For reagent, media, and supply checks, the laboratory must do the following: (e) (4) Before, or concurrent with the initial use-- (e)(4)(i) Check each batch of media for sterility if sterility is required for testing; (e)(4)(ii) Check each batch of media for its ability to support growth and, as appropriate, select or inhibit specific organisms or produce a biochemical response; and (e)(4)(iii) Document the physical characteristics of the media when compromised and report any deterioration in the media to the manufacturer. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on surveyor review of BACT/ALERT blood culture media records, and interview with the technical consultant, the laboratory does not check each batch blood culture media for its ability to support growth, inhibit specified organisms, maintain sterility, or document the physical characteristics of each lot of media. Findings include: 1. Review of BACT/ALERT blood culture media records show no evidence the laboratory documents the media's ability to support growth, inhibit specified organisms, maintain sterility, or document the physical characteristics for each lot of blood culture media used for patient testing. 2. Review of BACT/ALERT blood culture media records show the laboratory retains the Certificates of Conformance for each lot of blood culture media used for patient testing and no further quality control testing is performed. 3. Interview with technical consultant B on November 13, 2019 at 2:50 PM confirmed the laboratory does not perform blood culture media quality control and document the media's ability to support growth, inhibit specified organisms, maintain sterility, or document the physical characteristics for each lot of blood culture media used for patient testing. -- 2 of 2 --