Logan Health Shelby

Summary Statement of Deficiencies D5016 ROUTINE CHEMISTRY CFR(s): 493.1210 If the laboratory provides services in the subspecialty of Routine Chemistry, the laboratory must meet the requirements specified in 493.1230 through 493.1256, 493. 1267, and 493.1281 through 493.1299. This CONDITION is not met as evidenced by: Based on review of chemistry records, instrument manuals, product inserts, and policies and procedures, the laboratory failed to establish acceptable QC statistical parameters for each analyte tested on the Siemens Dimension EXL 200 analyzer (See 5469); failed to perform tHb calibration every three months and perform at least a three-point calibration verification on the OPTI CCA-TS Blood Gas Analyzer every six months (See D5535); and failed to assess the effectiveness of their quality monitoring as stated in their policy and procedure (See 5793). D5400 ANALYTIC SYSTEMS CFR(s): 493.1250 Each laboratory that performs nonwaived testing must meet the applicable analytic systems requirements in 493.1251 through 493.1283, 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 analytic systems and correct identified problems as specified in 493.1289 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: Based on a review of bacteriology, hematology, and blood bank records, instrument manuals, product inserts, and policies and procedures, the laboratory failed to verify Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 7 -- the performance specification of the two moderate complexity Clostridium difficile kits from different vendors prior to reporting patient test results (See D5421); failed to establish a procedure and perform function checks to verify the accuracy of pipettes used in the laboratory (See D5435); failed to perform the manufacturer's recommended calibration in 2021 for the Sysmex XS-1000 hematology analyzer (See D5439); failed to perform an external positive and negative control each day of patient testing or establish an Individualized Quality Control Plan (IQCP) for two moderate complexity Clostridium difficile kits from different vendors prior to patient testing (See D5445); and failed to perform alarm checks at the frequency dictated by their procedures to include the blood bank freezer storing fresh frozen plasma (See D5555). D5421 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(1) Each laboratory that introduces an unmodified, FDA-cleared or approved test system must do the following before reporting patient test results: (1)(i) Demonstrate that it can obtain performance specifications comparable to those established by the manufacturer for the following performance characteristics: (1)(i)(A) Accuracy. (1)(i) (B) Precision. (1)(i)(C) Reportable range of test results for the test system. (1)(ii) Verify that the manufacturer's reference intervals (normal values) are appropriate for the laboratory's patient population. This STANDARD is not met as evidenced by: Based on review of records, manufacturer's instructions, and interview with the Technical Supervisor (TS) #1, the laboratory failed to have the laboratory director evaluate and approve the performance specifications for two of two moderate complexity Clostridium difficile (C. diff) kits prior to reporting patient test results. Findings: 1. Review of QC records for "Serology Procedures Logbook" labeled with "C Diff Quik Chek Complete" revealed patients testing starting 12/18/2021. 2. Review of QC records for "Serology Procedures Logbook" labeled with "Immuno Card" revealed patients testing starting 7/22/2022. 3. No performance specification study to ensure the moderate complexity C. diff kits (C. Diff Quik Chek Complete and ImmunoCard Toxins A & B) results are comparable to those established by the manufacturer were available for review. 4. The manufacturer's instruction for C. Diff Quik Chek Complete and ImmunoCard Toxins A & B used as the procedure lacked review and approval by laboratory director prior to patient testing. 5. Interview with the (TS) #1 on October 6, 2022, at 12:40 PM, confirmed the laboratory failed to verify the performance specification of the two new C. diff kits prior to patient testing from December 18, 2021, to October 6, 2022. 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. -- 2 of 7 -- 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 pipettes used in the laboratory from January 1, 2021, to October 6, 2022. Findings: 1. Observation of pipettes (50 L, 100 L, and 200 L) in the laboratory available for use lacked verification labels. 2. Review of laboratory maintenance records lacked documentation of annual verification checks for pipettes from January 1, 2021, to October 6, 2022. 3. Review of policy and procedures lacked instruction to include the frequency of verification for pipettes. 4. An interview with the (TS) #1 on October 6, 2022, at 9:40 AM, confirmed pipettes were not being verified and the laboratory lacked a procedure or policy for the verification of pipettes from January 1, 2021, to October 6, 2022. 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 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 review of the calibration records for the Sysmex XS-1000 hematology analyzer for complete blood counts (CBC) with differential, and interview with the technical supervisor (TS) #1, the laboratory failed to perform the manufacturer's recommended calibration in year 2021. Findings: 1. No calibration records for the Sysmex XS-1000 hematology analyzer for the year of 2021 were available for review. 2. Interview with the (TS) #1 on October 6, 2022 at 1:20 PM confirmed the laboratory failed to perform the manufacturer's recommended calibration in 2021 for the Sysmex XS-1000 hematology analyzer . D5445 CONTROL PROCEDURES CFR(s): 493.1256(d)(1)(2)(g) -- 3 of 7 -- 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 review of records, manufacturer's instructions, and interview with the Technical Supervisor (TS) #1, the laboratory failed to perform one positive and one negative external quality control (QC) each day of patient testing or establish an Internal Quality Control Plan (IQCP) for alternative QC frequency as required by the manufacture's instruction for two of two moderate complexity Clostridium difficile (C. diff) kits from December 18, 2021, to October 6, 2022 Findings: 1. Review of quality control (QC) records for "Serology Procedures Logbook", one labeled with "C Diff Quik Chek Complete" and the other labeled with "ImmunoCard", revealed the laboratory failed to perform positive and negative external controls each day of patient testing. 2. The product insert for C. Diff Quik Chek Complete states, "The reactivity of the C. Diff Quik Chek Complete kit should be verified upon receipt using the Positive Control and Negative Control (Diluent)"; and for ImmunoCard Toxins A & B states, "The reactivity of each new lot and each new shipment of the ImmunoCard Toxin A & B should be verified on receipt or before use." 3. The laboratory failed to establish an (IQCP) to encompass a Risk Assessment (RA), a Quality Control Plan (QCP), and a Quality Assessment (QA) plan for alternative external QC practices as defined by the manufacturer's instructions. 4. An interview with the (TS) #1 on October 6, 2022, at 12:45 PM, confirmed the laboratory failed to either perform an external positive and negative control each day of patient testing or establish an IQCP for the two new C. diff kits from different vendors prior to patient testing from December 18, 2021, to October 6, 2022. D5469 CONTROL PROCEDURES CFR(s): 493.1256(d)(10)(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-- Establish or verify the criteria for acceptability of all control materials. (i) When control materials providing quantitative results are used, statistical parameters (for example, mean and standard deviation) for each batch and lot number of control materials must be defined and available. (ii) The laboratory may use the stated value of a commercially assayed control material provided the stated value is for the methodology and instrumentation employed by the laboratory and is verified by the laboratory. (iii) Statistical parameters for unassayed control materials must be established over time by the laboratory through concurrent testing of control materials having previously determined statistical parameters. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on review of chemistry quality control (QC) records, manufacturer's inserts and manual, patient reports, and interview with the technical supervisor (TS) #1, the -- 4 of 7 -- laboratory failed to establish acceptable criteria (statistical parameters/standard deviation) for unassayed controls MAS chemTRAK H level 1 (lot #22101A) and level 3 (lot #22103A) for chemistry analytes Chloride, Glucose, Lipase, Amylase, HDL Cholesterol, Triglycerides, and Iron performed on the Siemens Dimension EXL 200 from January 1, 2021 to October 6, 2022. Findings: 1. The laboratory failed to follow the Dimension EXL System Operator's Guide manual which states, "Each new quality control product of new lot of quality control material introduced should be evaluated in conjunction with the old lot during a trial period. This allows the newly established mean and standard deviation to be compared to the values of the old material."; and follow the MAS chemTRAK H product insert which states, "Instrument values provided are specific to this lot of control only and are intended to assist the laboratory in establishing its own means and ranges." 2. No concurrent studies of quality control materials to establish statistical limits were available for review. 3. Review of test volume sheet recording the last 12 months of patients' results showed 3049 Chloride, 3030 Glucose, 102 Amylase, 1221 HDL Cholesterol, 1230 Triglycerides and 87 Iron results were reported from 9/28/21 to 9/28/22. 4. Interview with (TS) #1 on October 6, 2022, at 2:10 PM confirmed the laboratory failed to establish acceptable QC statistical parameters for each analyte tested on the Siemens Dimension EXL 200 analyzer from January 1, 2021 to October 6, 2022. D5535 ROUTINE CHEMISTRY CFR(s): 493.1267(a)(d) For blood gas analyses, the laboratory must perform the following: (a) Calibrate or verify calibration according to the manufacturer's specifications and with at least the frequency recommended by the manufacturer. (d) Document all control procedures performed, as specified in this section. This STANDARD is not met as evidenced by: Based on review of blood gas calibration records for the OPTI CCA-TS, Individualized Quality Control Plan (IQCP), instrument manual, and interview with Technical Supervisor (TS) #1, the laboratory failed to follow their blood gas IQCP to perform quarterly tHb calibration and the manufacturer's instructions to perform at least three-point (a minimal, mid-point, and maximum) calibration verification every six months from January 1, 2021, to October 6, 2022. Findings: 1. Review of blood gas IQCP revealed the laboratory failed to perform tHb calibration verification as stated, "Every 3 months the Hb Calibrator cassette is performed on the OPTI CCA-TS Blood Gas Analyzer." 2. Calibration records lacked three out of four tHb calibrations for the year 2021 and one out of three from January 1, 2022 to October 6, 2022. 3. Review of the OPTI CCA-TS Operator's Manual revealed the laboratory failed to perform calibrations and calibration verifications as stated: "4.4 Calibration Verification: Calibration verification allows for the validation of the blood gas analyzer's ability to recover known values at various points within the reportable range of all parameters and may be required by various regulatory agencies." 4. No calibration verifications performed every six months or records of three levels of controls being performed each day of testing were available for review. 5. Interview with the (TS) #1 on October 6, 2022, at 11:30 AM, confirmed the laboratory failed to perform tHb calibration every three months and perform at least a three-point calibration verification on the OPTI CCA-TS Blood Gas Analyzer every six months from January 1, 2021, to October 6, 2022. D5555 IMMUNOHEMATOLOGY -- 5 of 7 -- CFR(s): 493.1271(c)(f) (c) Blood and blood products storage. Blood and Blood products must be stored under appropriate conditions that include an adequate temperature alarm system that is regularly inspected. (c)(1) An audible alarm system must monitor proper blood and blood product storage temperature over a 24-hour period. (c)(2) Inspections of the alarm system must be documented. (f) Documentation. The laboratory must document all control procedures performed, as specified in this section. This STANDARD is not met as evidenced by: Based on observation, review of procedures, records of blood bank alarm checks, and interview with the Technical Supervisor (TS) #1, the laboratory failed to perform and document quarterly alarm inspection checks for one of one blood bank freezer to ensure the proper storage of fresh frozen (FFP) plasma from January 1, 2021 to October 6, 2022. Findings: 1. Observed one freezer storing fresh frozen plasma (FFP) on October 6, 2022, located in the laboratory. 2. Review of procedure " Maintenance and Quality Control" revealed the laboratory failed to perform alarm tests for the blood bank freezer as stated, "At least once a quarter high low check will be performed." 3. No alarms checks for the blood bank freezer storing FFP blood products were available for review. 4. An interview with (TS) # 1 on October 5, 2022, at 11:00 A.M. confirmed the laboratory failed to perform alarm checks at the frequency dictated by their procedures to include the blood bank freezer storing FFP blood products from January 1, 2021, to October 6, 2022. 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 D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) The procedure manual must include the following when applicable to the test procedure: (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. (2) Microscopic examination, including the detection of inadequately prepared slides. (3) Step-by-step performance of the procedure, including test calculations and interpretation of results. (4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (5) Calibration and calibration verification procedures. (6) The reportable range for test results for the test system as established or verified in 493.1253. (7) Control procedures. (8)

Summary Statement of Deficiencies D6076 LABORATORY DIRECTOR CFR(s): 493.1441 The laboratory must have a director who meets the qualification requirements of 493. 1443 of this subpart and provides overall management and direction in accordance with 493.1445 of this subpart. This CONDITION is not met as evidenced by: Based on routine desk audit of CMS-153 and 155 reports of proficiency testing performance and interview, the laboratory director failed to provide overall management of the laboratory by failing to ensure the quality assessment (QA) program was adequate and maintained for correct data entry and submission of proficiency testing results for CKMB. See D6094. D6094 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(5) The laboratory director must ensure that the quality assessment programs are established and maintained to assure the quality of laboratory services provided and to identify failures in quality as they occur. This STANDARD is not met as evidenced by: Based on record review and interview, the laboratory director failed to ensure the quality assessment (QA) program was maintained for verification of correct data entry and submission for proficiency testing results for three of four proficiency testing events. The findings include: 1. A review on 4/4/18 at 4:36 p.m. of the CMS-153 Unsuccessful Proficiency Testing Report included the laboratory failure to achieve satisfactory scores in two of three proficiency testing events for CKMB (2017 event 3 and 2018 event 1). 2. The laboratory director was notified through email of initial 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 -- unsuccessful proficiency testing performance for CKMB on 4/5/18 at 1:53 p.m. 3. A review on 4/5/18 at 4:56 p.m. of the allegation of compliance written included a QA plan for proficiency testing entry. 4. On 10/8/18 at 3:24 p.m., the laboratory notified the state agency through e-mail that they had received another failing score for CKMB. 5. A review on 10/22/18 at 8:30 a.m. of the CMS-153 Unsuccessful Proficiency Testing Report included the laboratory failure to achieve satisfactory scores in three of four proficiency testing events for CKMB (2017 event 3, 2018 event 1, and 2018 event 3). -- 2 of 2 --

Summary Statement of Deficiencies D0000 Based on an off-site proficiency testing desk review conducted on 10/22/18, deficiencies were cited for Marias Medical Center in Shelby, MT. 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 routine desk audit of CMS-153 and 155 reports of proficiency testing performance and interview, the laboratory failed to achieve satisfactory performance for theophylline and an overall score for toxicology for two of three events (2018 event 1 and 2018 event 3), resulting in unsuccessful proficiency testing performance. See D2118 and D2119. 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 -- D2118 TOXICOLOGY CFR(s): 493.845(f) Failure to achieve satisfactory performance for the same analyte or test in 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 review of proficiency testing scores and interview, the laboratory failed to achieve a score of 80 percent for theophylline in two of three events in 2018, resulting in unsuccessful performance. The findings include: 1. On 10/8/18 at 3:24 p.m., the laboratory manager emailed regarding the failed submission of proficiency testing results. 2. During a review on 10/22/18 at 8:30 a.m. of the CMS-153 Unsuccessful Proficiency Testing Report included Marias Medical Center with unsuccessful proficiency testing scores for theophylline. 3. During a review on 10/22/18 at 8:36 a. m. of the CMS-155 report, the American Proficiency Institute (API) theophylline score for event 1 of 2018 was 20%. 4. During a review on 10/22/18 at 8:36 a.m. of the CMS-155 report, the API theophylline score for event 3 of 2018 was 0%. D2119 TOXICOLOGY CFR(s): 493.845(g) 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 review of proficiency testing scores and interview, the laboratory failed to achieve a score of 80 percent for toxicology in two of three events in 2018, resulting in unsuccessful performance. The findings include: 1. On 10/8/18 at 3:24 p.m., the laboratory manager emailed regarding the failed submission of proficiency testing results. 2. During a review on 10/22/18 at 8:30 a.m. of the CMS-153 Unsuccessful Proficiency Testing Report included Marias Medical Center with unsuccessful proficiency testing scores for toxicology. 3. During a review on 10/22/18 at 8:36 a.m. of the CMS-155 report, the API toxicology score for event 1 of 2018 was 73%. 4. During a review on 10/22/18 at 8:36 a.m. of the CMS-155 report, the API toxicology score for event 3 of 2018 was 0%. -- 2 of 2 --

Summary Statement of Deficiencies D0000 Based on an on-site recertification survey conducted on 10/15/18-10/16/18, deficiencies were cited for Marias Medical Center in Shelby, MT. D2000 ENROLLMENT AND TESTING OF SAMPLES CFR(s): 493.801 Each laboratory must enroll in a proficiency testing (PT) program that meets the criteria in subpart I of this part and is approved by HHS. The laboratory must enroll in an approved program or programs for each of the specialties and subspecialties for which it seeks certification. The laboratory must test the samples in the same manner as patients' specimens. For laboratories subject to 42 CFR part 493 published on March 14, 1990 (55 FR 9538) prior to September 1, 1992, the rules of this subpart are effective on September 1, 1992. For all other laboratories, the rules of this subpart are effective January 1, 1994. This CONDITION is not met as evidenced by: Based on observation, record review, and interview, the laboratory failed to perform proficiency testing for phenytoin from 2/9/16 through 10/15/18. The findings include: 1. On 10/15/18 at 12:45 p.m., a Siemens Dimension EXL 200 analyzer was observed in the laboratory. 2. On 10/15/18 at 12:45 p.m., staff member A listed phenytoin in the tests performed on the analyzer. 3. A review on 10/15/18 at 1:25 p.m. of the 2017 and 2018 American Proficiency Institute (API) binders lacked documentation of phenytoin proficiency testing results. 4. On 10/15/18 at 1:25 p.m., staff member A stated phenytoin was ordered but they didn't perform it. D5437 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(a) Unless otherwise specified in this subpart, for each applicable test system the laboratory must perform and document calibration procedures-- (1) Following 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 3 -- manufacturer's test system instructions, using calibration materials provided or specified, and with at least the frequency recommended by the manufacturer; (2) Using the criteria verified or established by the laboratory as specified in 493.1253(b) (3)-- (2)(i) Using calibration materials appropriate for the test system and, if possible, traceable to a reference method or reference material of known value; and (2)(ii) Including the number, type, and concentration of calibration materials, as well as acceptable limits for and the frequency of calibration; and (3) Whenever calibration verification fails to meet the laboratory's acceptable limits for calibration verification. This STANDARD is not met as evidenced by: Based on observation, record review, and interview, the laboratory failed to follow the manufacturer's calibration frequency instructions for six tests between 2/9/17 and 10 /15/18. The findings include: 1. On 10/15/18 at 12:45 p.m., a Siemens Dimension EXL 200 analyzer was observed in the laboratory. 2. On 10/15/18 at 4:20 p.m., staff member A stated the laboratory may not perform chemistry calibrations in certain situations. 3.. A review on 10/16/18 at 9:45 a.m. of the calibration dates stored on the analyzer, the calibration frequency requirements listed on the Siemens package inserts, and a list of patient results showed patient results released after the calibrations had expired between 2/9/17 and 10/15/18. a. Acetaminophen manufacturer instructions required calibrations to be performed every 90 days for any one lot and with new lots. 1. Calibrations were performed by the laboratory on 1/26 /17, 6/12/17, 11/18/17, 1/26/18, 6/28/18, and 10/1/18. 2. 5 patients were resulted when the calibration had expired. a. 6/4/17, 6/5/17, 10/24/17, 11/3/17, and 5/10/18. b. Digoxin manufacturer instructions required calibrations to be performed every month for any one lot and with each new lot. 1. Calibrations were performed by the laboratory on 1/26/17, 5/18/17, 8/16/17, 11/27/17, 12/7/17, 5/24/18, and 9/20/18. 2. 20 patients were resulted when the calibration had expired. a. 3/4/17, 3/7/17, 3/15/17, 3/22/17, 3/26/17, 4/20/17, 4/23/17, 4/25/17, 7/28/17, 2/13/18, 2/21/18 (2 patients), 2 /26/18, 3/19/18, 3/21/18, 4/19/18, 7/3/18, 7/18/18, and 8/30/18 (2 patients). c. Salicylates manufacturer instructions required calibrations to be performed every three months for any one lot and with each new lot. 1. Calibrations were performed by the laboratory on 11/7/16, 3/27/17, 9/1/17, 11/7/17, 3/15/18, 8/14/18, and 10/15/18. 2. 8 patients were resulted when the calibration had expired. a. 2/10/17, 2/16/17, 3/24 /17, 2/27/18, 7/25/18, 7/27/18, 8/5/18, 8/13/18. d. Phenytoin manufacturer instructions required calibrations to be performed every thirty days for any one lot and with each new lot. 1. Calibrations were performed by the laboratory on 3/24/17, 5/5/17, 6/25/17, 8/2/17, 9/1/17, 10/4/17, 3/30/18, and 10/15/18. 2. 8 patients were resulted when the calibration had expired. a. 11/22/17, 5/16/18 (2 patients), 5/29/18, 7/19/18, 8/8/18, 9/5 /18, and 9/18/18. e. Cerebral spinal fluid (CSF) total protein manufacturer instructions required calibrations to be performed every two months for any one lot and with each new lot. 1. Calibrations were performed by the laboratory on 3/30/15, 2/16/18, and 4 /27/18. 2. 2 patients were resulted when the calibration had expired. a. 8/24/18 and 9/3 /18. f. Vancomycin manufacturer instructions required calibrations to be performed every thirty days for any one lot and with each new lot. 1. Calibrations were performed by the laboratory on 12/22/16, 3/24/17, 5/9/17, 8/31/17, 3/17/18, and 6/28 /18. 2. 12 patients were resulted when the calibration had expired. a. 2/12/17, 2/14/17, 6/11/17, 6/13/17, 6/20/17, 6/23/17, 10/31/17, 1/7/18, 5/1/18, 7/31/18, 8/2/18, and 9/4 /18. D5471 CONTROL PROCEDURES CFR(s): 493.1256(e)(1)(g) -- 2 of 3 -- (e) For reagent, media, and supply checks, the laboratory must do the following: (e)(i) Check each batch (prepared in-house), lot number (commercially prepared) and shipment of reagents, disks, stains, antisera, (except those specifically referenced in 493.1261 (a)(3)) and identification systems (systems using two or more substrates or two or more reagents, or a combination) when prepared or opened for positive and negative reactivity, as well as graded reactivity, if applicable. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on observation, record review, and interview, the laboratory failed to document positive reactivity for 4 of 36 biochemical identification (ID) system reactions for two lots of gram negative organism ID systems. The findings include: 1. On 10/15/18 at 2: 30 p.m., two gram negative ID systems were observed in the laboratory. a. Negative /Urine Combo (NUC) 75. b. NUC 85. 2. A review on 10/15/18 at 5:30 p.m. of the MicroScan Neg ID Panel Type 2/Biochemical Quality Control Report Forms lacked documentation of positive reactivity for 4 reactions. a. NUC 75, lot number 2019-05- 03. 1. Cephalothin reistance (Cf>8) lacked a documented positive reaction. 2. Colistin resistance (Cl>4) lacked a documented positive reaction. b. NUC 85, lot number 2019- 05-31. 1. Cf>8 lacked a documented positive reaction. 2. Tartrate (TAR) lacked a documented positive reaction. 3. On 10/15/18 at 5:30 p.m., staff member A stated the forms were not filled out correctly. D5537 ROUTINE CHEMISTRY CFR(s): 493.1267(b)(d) For blood gas analyses, the laboratory must perform the following: (b) Test one sample of control material each 8 hours of testing using a combination of control materials that include both low and high values on each day of testing. (d) Document all control procedures performed, as specified in this section. This STANDARD is not met as evidenced by: Based on observation, record review, and interview, the laboratory failed to test control materials every eight hours of patient testing for one of one patient reviewed. The findings include: 1. On 10/16/18 at 8:30 a.m., an Opti-CCA-TS analyzer was observed in the radiology department. 2. A review on 10/16/18 at 9:00 a.m. of one patient (#160002) blood gas results from 1/10/18 included electronic controls but lacked liquid control material performed on that day. 3. A review on 10/16/18 at 9:00 a.m. of the blood gas binder included daily electronic standard reference cassette (SRC) controls and monthly liquid control materials performed on the Opti-CCA-TS. 4. On 10/16/18 at 9:00 a.m., staff member A stated the laboratory did not have an Individual Quality Control Plan for the blood gas analyzer. -- 3 of 3 --

Summary Statement of Deficiencies D0000 Based on an offsite proficiency desk review conducted on 4/4/18, deficiencies were cited for Marias Medical Center in Shelby, MT. 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 routine desk audit of CMS-153 and 155 reports of proficiency testing performance and interview, the laboratory failed to achieve satisfactory performance for creatine kinase isoenzyme (CKMB) for two consecutive events (event 3 of 2017 and event 1 of 2018), resulting in unsuccessful proficiency testing performance. See D2096. 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 -- D2096 ROUTINE CHEMISTRY CFR(s): 493.841(f) Failure to achieve satisfactory performance for the same analyte or test in 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 review of proficiency testing scores and interview, the laboratory failed to achieve a score of 80 percent for creatine kinase, isoenzyme (CKMB) in two consecutive events in 2017 and 2018, resulting in unsuccessful performance. The findings include: 1. During a review on 4/4/18 at 4:36 p.m. of the CMS-153 Unsuccessful Proficiency Testing Report included Marias Medical Center with unsuccessful proficiency testing scores for CKMB. 2. During a review on 4/4/18 at 4: 40 p.m. of the CMS-155 report, the American Proficiency Institute (API) CKMB score for event 3 of 2017 was 60%. 3. During a review on 4/4/18 at 4:40 p.m. of the CMS-155 report, the API CKMB score for event 1 of 2018 was 60%. 4. On 4/5/18 at 1:26 p.m., the laboratory manager stated the wrong analyzer was chosen for both events. -- 2 of 2 --