Madison Valley Medical Center

Summary Statement of Deficiencies 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: Based on a review of American Proficiency Institute records and an interview with the technical supervisor (TS) #1, the laboratory failed to achieve satisfactory performance for partial thromboplastin time (APTT) for two out of three testing events and urine susceptibility testing for two consecutive events, resulting in unsuccessful proficiency testing performance. (See D2028 and D2130). D2028 BACTERIOLOGY CFR(s): 493.823(e) 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 -- Failure to achieve an overall testing event score of satisfactory performance for two consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on a review of American Proficiency Institute (API) records and an interview with the technical supervisor (TS) #1, the laboratory failed to achieve a score of at least 80% for two consecutive events for urine susceptibility testing using agar disk diffusion. Findings: 1. A review of the API susceptibility testing (urine) proficiency testing scores revealed that in 2024, the 1st Event scored 67%, and the 2nd Event scored 50%. 2. An interview with TS #1 on August 28, 2024, at 10:35 AM confirmed the laboratory failed to achieve successful performance for susceptibility testing (urine) for Events 1 and 2 in 2024. D2130 HEMATOLOGY CFR(s): 493.851(f) Failure to achieve satisfactory performance for the same analyte in two consecutive events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on a review of American Proficiency Institute (API) records and an interview with the technical supervisor (TS) #1, the laboratory failed to achieve a score of at least 80% for two out of three testing events for partial thromboplastin time (APTT) performed on the Diagnostica Stago ST4 Coagulation Analyzer. Findings: 1. A review of the API partial thromboplastin time (APTT) proficiency testing scores revealed that in 2023, the 3rd Event scored 20%, and in 2024, the 2nd Event scored 20%. 2. An interview with TS #1 on August 28, 2024, at 10:30 AM confirmed the laboratory's failed APTT proficiency scores for the 2023 3rd Event and the 2024 2nd Event were due to calculation errors. 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 a record review and an interview with the technical supervisor (TS) #1, the laboratory failed to establish a procedure and perform competency assessments for the technical supervisor and general supervisor listed on the CMS-209 Personnel Report form from August 28, 2022, to August 28, 2024 and failed to follow their procedure to assess eleven out of fourteen testing personnel annually for 2023 and assess three out of six new hires prior to patient testing and/or at six months. Findings: 1. A review of the CMS-209 Personnel Report Form revealed one personnel listed as general supervisor and technical supervisor and lacked a competency assessment based on the position responsibilities from August 28, 2022, to August 28, 2024. 2. A review of the Annual Competency Review procedure lacked the frequency of the technical supervisor and general supervisor competency assessment based on their federal -- 2 of 3 -- regulatory responsibilities and failed to list the six required procedures as part of their annual competency for testing personnel. 3. The laboratory failed to follow their Annual Competency Review procedure to either assess new hires prior to patient testing and/or perform an assessment at 6-months of hire for three out of six laboratory testing personnel (TP) (TP# 13, 16, and 17). 4. A review of testing personnel (TP) files lacked documentation of annual competency for year 2023 for eleven out of fourteen testing personnel (TP# 5, 6, 7, 8, 9, 10, 11, 14, 15, 18, and 19) as required by their Annual Competency Review procedure. 5. An interview with TS #1 on August 28, 2024, at 9:15 AM confirmed the laboratory failed to follow their procedure to perform initial, 6-month assessments on new hires and annual competency assessments for year 2023 and lacked a procedure to perform and assess the technical supervisor and general supervisor based on the position responsibilities from August 28, 2022, to August 28, 2024. -- 3 of 3 --

Summary Statement of Deficiencies D5435 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(b)(2) For equipment, instruments, or test systems developed in-house, commercially available and modified by the laboratory, or maintenance and function check protocols are not provided by the manufacturer, the laboratory must: (i) Define a function check protocol that ensures equipment, instrument, and test system performance that is necessary for accurate and reliable test results and test result reporting. (ii) Perform and document the function checks, including background or baseline checks, specified in paragraph (b)(2)(i) of this section. Function checks must be within the laboratory's established limits before patient testing is conducted. This STANDARD is not met as evidenced by: Based on observation, review of maintenance documentation, policy and procedures, and interview with technical supervisor (TS) #1 the laboratory failed to establish a procedure and perform function checks to verify the accuracy of one of one pipette used in the laboratory from January 1, 2021, to November 30, 2022. Findings: 1. Observed one 50 L Fisher Brand pipette in the laboratory available for use with no verification labels. 2. A review of laboratory maintenance records lacked documentation of annual verification checks for the pipette for years 2021 and 2022. 3. A review of policy and procedures lacked instruction to include the frequency and type of accuracy checks for the pipette. 4. An interview with the (TS) #1 on November 30, 2022, at 9:40 AM, stated the laboratory was not aware that the pipette needed to be verified for accuracy from January 1, 2021 to November 30, 2022 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-- 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 -- (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 review of quality control (QC) records, laboratory policies and procedures, Individualized Quality Control Plan (IQCP) and interview with the Technical Supervisor (TS) #1, the laboratory failed to establish, follow, and perform external control at the frequency required by their procedure or manufacturer's instructions for Pro Advantage human chorionic gonadotropin (HCG) serum and urine kits, DCA Vantage Microalbumin and Creatinine and the Alere Triage D-dimer from January 1, 2021 to November 30, 2022. Findings: 1. A review of Pro Advantage package insert for the detection of HCG in urine and serum revealed the laboratory failed to follow manufacture's instructions as stated, "For urine testing, controls should be tested with each new lot or shipment of product, with each new operator, monthly as a check on continued storage conditions." 2. A review of Serology Worksheet for HGC QC records lacked an external positive and negative urine control for February, March, April, May, June, July, August, September, and October of 2022. 3. A review of Serum HCG IQCP revealed the laboratory failed to follow their procedure to perform external positive and negative serum controls "for each kit upon receipt of the kit." 4. A review of Serology Worksheet for HGC QC records lacked an external positive and negative check for a new HCG kit (lot number 1052044 exp date 5/31/2023) used to test 29 of 29 patients from June 18, 2022 to November 30, 2022 5. A review of IQCP for DCA Vantage Microalbumin/Creatinine revealed the laboratory failed to perform external controls as stated, "Two levels are run when the box arrives, and one level of control is run monthly thereafter." 6. A review of Microalbumin Creatinine Worksheet revealed the laboratory failed to perform one level of external control for microalbumin and one level of external control for creatinine for February, June, July, August, October, and November for 2021 and January, February, March, April, May, June, July, August, September, and October of 2022. 7. A review of Microalbumin Creatinine Worksheet revealed the laboratory failed to perform two levels of external controls for both creatinine and microalbumin for kit lot# 0463 expiration date 2-24 used to test 27 of 27 patients from July 12, 2022 to October 31, 2022 8. A review of DCA Vantage Operator's Guide revealed the lab failed to run quality control as stated, "each time a calibration card is scanned" and record results. No DCA Vantage calibration records were available for review. 9. A review of IQCP for the Alere Triage D-dimer revealed the laboratory failed to follow their procedure to perform external QC at the frequency defined, "Two levels are run when the box arrives, and one level of control is run monthly thereafter." 10. A review of Triage D-dimer QC revealed the laboratory failed to perform one level of external control for August, October, and December for the year 2021 and January, February, March, April, May, June, August and November of the year 2022. 11. An interview with the TS #1 on November 30, 2022, at 9:30 AM, confirmed the laboratory failed to establish, follow, and perform external qc at the frequency required by their, IQCP or manufacturer's instruction from January 1, 2021, through November 30, 2022 for the above listed platforms. D5473 CONTROL PROCEDURES CFR(s): 493.1256(e)(2)(g) -- 2 of 3 -- (e) For reagent, media, and supply checks, the laboratory must do the following: (e) (2) Each day of use (unless otherwise specified in this subpart), test staining materials for intended reactivity to ensure predictable staining characteristics. Control materials for both positive and negative reactivity must be included, as appropriate. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on a review of hematology records and interview with the technical supervisor (GS)#1, the laboratory failed to document the intended staining characteristics for each day manual differentials slides were stained from January 1, 2021 to November 30, 2022. Findings: 1. A review of hematology records revealed the laboratory failed to document the staining quality of manual differential slides each day that slides are stained for the years 2021 and 2022. 2.The hematology procedure lacked how the laboratory would document staining quality control checks for manual differentials slides. 3. An interview on November 30, 2022, at 11:30 AM with TS #1 confirmed the laboratory failed to document staining quality of manual differential slides from January 1, 2021 to November 30, 2022. D5791 ANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1289(a)(c) (a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and when indicated, correct problems identified in the analytic systems specified in 493.1251 through 493.1283. (c) The laboratory must document all analytic systems assessment activities. This STANDARD is not met as evidenced by: Based on review of quality control records, Individualized Quality Control Plan (IQCP), and interview with Technical Supervisor (TS) #1, the laboratory failed to include an ongoing mechanism to monitor, assess and correct problems in their IQCP's quality control plan to prevent the lack of quality controls (QC) performed for human chorionic gonadotropin (HCG), D-dimer, Microalbumin and Creatinine performed in the laboratory from January 1, 2021 to November 30, 2022. Findings: 1. The laboratory's Quality Control Plan for serum HCG, DCA Vantage Microalbumin and Creatinine and the Alere Triage D-dimer lacked instruction for ongoing mechanism to monitor, assess and correct problems. 2. No annual IQCP assessments were available for review. 3. A review of Serology Worksheet for HGC, Microalbumin Creatinine Worksheet and Triage D-dimer QC Records lacked review for quality assessment checks. 3. An interview with TS #1 on November 30, 2022, at 5:00PM, confirmed the laboratory failed to have included in their IQCP's quality control plan an ongoing mechanism to monitor, assess and correct problems and failed to perform quality assessments checks from January 1, 2021 to November 30, 2022. -- 3 of 3 --

Summary Statement of Deficiencies D5775 COMPARISON OF TEST RESULTS CFR(s): 493.1281(a)(c) (a) If a laboratory performs the same test using different methodologies or instruments, or performs the same test at multiple testing sites, the laboratory must have a system that twice a year evaluates and defines the relationship between test results using the different methodologies, instruments, or testing sites. (c) The laboratory must document all test result comparison activities. This STANDARD is not met as evidenced by: Based on record review of 2019, 2020 instrument comparison documentation and interview with technical supervisor (TS) #1, the laboratory failed to perform instrument comparison for the analyzers, CoaguChek and Stago Start 4 for prothrombin two times a year. Findings: 1. Review of laboratory instrument comparison documentation showed the laboratory failed to perform and document comparison studies for the CoaguChek and Stago Start 4 analyzers performing prothrombin analyte testing for 2019 and 2020. 3. Interview with technical supervisor TS #1 on 3/15/2021 at 10:30 AM confirmed the laboratory failed to perform twice a year instrument comparison. D6128 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(9) The technical supervisor is responsible for evaluating and documenting the performance of individuals responsible for high complexity testing at least annually after the first year, unless test methodology or instrumentation changes, in which case, prior to reporting patient test results, the individual's performance must be reevaluated to include the use of the new test methodology or instrumentation. 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 review of 2019 competency records, Quality Assessment Plan for i-State Troponin, and interview, the technical supervisor (TS) #1 failed to perform annual competency assessment for 7 of 17 Testing Personnel (TP). Findings: 1. Review of personnel competency evaluations revealed that laboratory failed to provide proof of annual competency assessments for TP #1, TP #10, TP #13, TP #14, TP #15, TP #16, TP #17 for year 2019. 2. Review of laboratory procedure, Quality Assessment Plan for i-State Troponin revealed "9. A six-month competency review for new employees will be performed as well as an annual competency by the Laboratory manager on a direct observation method." 3. Interview with Technical Supervisor (TS) #1 on 3/15 /2021 at 11:00 AM confirmed the laboratory failed to perform 7 of 17 testing personnel competency assessments for year 2019. -- 2 of 2 --

Summary Statement of Deficiencies D0000 Based on an on-site recertification survey conducted on 5/7/18, deficiencies were cited for Madison Valley Medical Center in Ennis, MT. 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 record review and interview, the laboratory failed to include the number of controls performed in two of five Individual Quality Control Plans (IQCPs) reviewed. The findings include: 1. A review on 5/7/18 at 11:05 a.m. of the Madison Valley Medical Center IQCPs for the Biofire Filmarray gastrointestinal and respiratory panels lacked the number of controls to be performed for these tests. 2. On 5/7/18 at 2: 00 p.m., staff member A stated the number was not specified in the IQCPs. 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 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 -- concentrations; (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on record review, and interview, the laboratory failed to perform two levels of quality control (QC) every day of patient testing for C-reactive protein (CRP) on four of sixty one days reviewed between 4/1/17 through 5/31/17. The findings include: 1. A review on 5/7/18 at 2:35 p.m. of QC prior to 5/9/17 on the chemistry analyzer was erased due to the analyzer retaining only 365 days of data. 2. On 5/7/18 at 2:35 p.m., staff member A stated the instrument QC printouts are not retained. 3. A review on 5/7 /18 at 3:50 p.m. of QC in the laboratory information system (LIS) included four days of patient CRP results without QC results within 24 hours between 4/1/17 and 5/31 /17. a. 4/6/17. b. 4/8/17. c. 4/23/17. d. 5/27/17. 4. On 5/7/18 at 3:50 p.m., staff member A stated the CRP control vial is separate from all other QC vials except troponin. 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 record review, and interview, the laboratory failed to document sterility, growth, inhibition of growth, and biochemical response for five of six types of media from 7/1/16 through 5/7/18. The findings include: 1. A review on 5/7/18 at 4:05 p.m. of the shipping packaging lists lacked documentation for five media types. a. Blood agar lacked documentation of growth, biochemical response, and sterility. b. MacConkey agar lacked documentation of growth, inhibition of growth, biochemical response, and sterility. c. Mueller-Hinton agar lacked documentation of sterility. d. HardyChrom agar lacked documentation of sterility. e. Thioglycollate media lacked documentation of growth and sterility. 2. On 5/7/17 at 4:30 p.m., staff member A stated the organisms are set up weekly on the agar plates but the results are not documented. 3. A review on 5/7/18 at 4:40 p.m. of the Madison Valley Medical Center Media Batch Controls Stock QC Organisms policy included that "each shipment of media will be inspected for sterility, ability to support growth, selective growth and biochemical response. A label will be added to the shipment packing list noting the condition of products and other control measures taken." D6128 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(9) The technical supervisor is responsible for evaluating and documenting the performance of individuals responsible for high complexity testing at least annually after the first year, unless test methodology or instrumentation changes, in which case, prior to reporting patient test results, the individual's performance must be reevaluated to include the use of the new test methodology or instrumentation. -- 2 of 3 -- This STANDARD is not met as evidenced by: Based on record review and interview, the technical supervisor failed to evaluate and document annual competency assessments for 15 of 17 testing personnel from 7/1/16 to 5/7/18. The findings include: 1. A review on 5/7/18 at 9:45 a.m. of the competency documents lacked competency assessments for 15 of 17 testing personnel. 2. On 5/7 /18 at 11:30 a.m., staff member A stated competency was not done. An annual demonstration of testing is completed during an in-service for 14 of the 17 testing personnel, but the competency requirements are not done. -- 3 of 3 --