Ruby Valley Hospital

Summary Statement of Deficiencies D5026 IMMUNOHEMATOLOGY CFR(s): 493.1217 If the laboratory provides services in the specialty of Immunohematology, the laboratory must meet the requirements specified in 493.1230 through 493.1256, 493. 1271, and 493.1281 through 493.1299. This CONDITION is not met as evidenced by: Based on a record review of immunohematology and the laboratory's procedures, the laboratory failed to follow their procedure to ensure the blood bank reagents were not used past their expiration date (refer to D5417); failed to follow their procedure to perform and document quarterly maintenance for the Grifols DG Gel 8 Manual System (refer to 5431); failed to follow their procedure to perform blood bank quality control (QC) each day of patient testing (refer D5551); and failed to perform and document quarterly alarm checks (refer to D5555). 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 29, 2022, to August 29, 2024, and failed to follow their procedure to assess three out of three new hires prior to patient testing and/or at six months after 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 -- employment. 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 29, 2022, to August 29, 2024. 2. A review of the Competency Assessments procedure lacked the frequency of the technical supervisor and general supervisor competency assessment based on their federal regulatory responsibilities. 3. The laboratory failed to follow their Competency Assessments procedure to either assess initial hires (during training) and/or at 6-months after employment for three out of three laboratory testing personnel (TP) (TP# 1, 2, and 3). 4. An interview with TS #1 on August 29, 2024, at 8: 30 AM confirmed the laboratory failed to follow their procedure to perform initial and /or 6-month assessments on new hires and lacked a procedure to perform and assess the technical supervisor and general supervisor based on the position responsibilities from August 29, 2022, to August 29, 2024. D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) Reagents, solutions, culture media, control materials, calibration materials, and other supplies must not be used when they have exceeded their expiration date, have deteriorated, or are of substandard quality. This STANDARD is not met as evidenced by: Based on a record review, procedure, and an interview with the technical supervisor (TS) #1, the laboratory failed to follow their procedure to ensure the blood bank's Grifols DG Gel 8 test system reagents and DG Gel Essential Controls were not used past their expiration date for eleven patients tested from March 6, 2023, to June 28, 2023. Findings: 1. A review of the "DG Gel Essential Control Log" revealed staff failed to prevent the use of expired reagents (Grifols Diluent expired 3/31/2023, A1 Reverse-Cyte, B Reverse-Cyte, Seach-Cyte-Plus I, and Search-Cyte Plus II expired 3 /18/2023), DG Essential quality controls (QC) (QC11 and QC12 expired 3/18/2023), and cards (DG Gel 8 A/B/D card expired 2/28/23, DG Gel 8 Neutral card expired 3/31 /2023 and DG Gel 8 Anti-IgG expired 3/31/2023) to test three patients on 3/6/2023, 4 /10/2023 and 5/4/2023. 2. A review of the "DG Gel Essential Control Log" revealed expired QC (QC11 and QC12 expired 5/13/2023) were used to perform testing on 5/22 /2023, 6/14/2023, 6/21/2023, and 6/28/2023 for eight patients. 3. A review of the "Grifols DG Gel 8 Quality Control" procedure revealed that the laboratory failed to follow their procedure to not use reagents and controls beyond the expiration date. 4. An interview with TS #1 on August 29, 2024, at 3:30 PM confirmed the laboratory staff failed to follow their procedure to not use expired Grifols DG Gel 8 test system reagents and DG Gel Essential Controls on eleven patients tested from March 6, 2023, to June 28, 2023. D5431 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(2) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document function checks as defined by the manufacturer and with at least the frequency specified by the manufacturer. Function checks must be within the manufacturer's established limits before patient testing is conducted. This STANDARD is not met as evidenced by: -- 2 of 5 -- Based on record review, procedures, and an interview with the technical supervisor (TS) #1, the laboratory failed to follow their procedure to perform and document quarterly maintenance for the Grifols DG Gel 8 Manual System from January 1, 2023, to March 5, 2024. Findings: 1. A review of the "Blood Bank Temperature and Maintenance Log" lacked documentation of quarterly maintenance for the Card Probe Temperature, DG Therm Timer P1 and P2 Check, DG Therm Card Elevator Check, DG Spin RPM Check, DG Spin Timer Check, and DG Spin out of Balance Check as required by their "Grifols DG Gel 8 Manual System Maintenance" procedure to preserve the function of the Grifols DG Gel 8 Manual System. 2. An interview with TS #1 on August 29, 2024, at 1:30 PM confirmed the laboratory failed to follow their procedure to perform and document quarterly maintenance for the Grifols DG Gel 8 Manual System from January 1, 2023, to March 5, 2024. D5551 IMMUNOHEMATOLOGY CFR(s): 493.1271(a)(f) (a) Patient testing. (a)(1) The laboratory must perform ABO grouping, D (Rho) typing, unexpected antibody detection, antibody identification, and compatibility testing by following the manufacturer's instructions, if provided, and as applicable, 21 CFR 606.151(a) through (e). (a)(2) The laboratory must determine ABO group by concurrently testing unknown red cells with, at a minimum, anti-A and anti-B grouping reagents. For confirmation of ABO group, the unknown serum must be tested with known A1 and B red cells. (a)(3) The laboratory must determine the D (Rho) type by testing unknown red cells with anti-D (anti-Rho) blood typing reagent. (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 a review of blood bank records, procedures and an interview with the technical supervisor (TS) #1, the laboratory failed to follow their procedure to perform blood bank quality control (QC) each day of patient testing for five out of five patients transfused from June 15, 2023, to August 23, 2023, and one API proficiency testing event performed on August 19, 2023. Findings: 1. A review of the "DG Gel Essential Control Log" revealed staff failed to follow their "Grifols DG Gel 8 Quality Control" procedure to perform QC each day a patient was tested and then transfused on 6/15/2023, 6/23/2023, 6/26/2023, 8/8/2023, and 8/23/2023. 2. A review of the API Proficiency testing records and "DG Gel Essential Control Log" revealed quality control was not performed on 8/19/2023, the day of testing. 3. An interview with TS #1 on August 29, 2024, at 3:15 PM confirmed the laboratory failed to perform QC each day patients were tested, and on the day proficiency testing was performed from June 15, 2023, to August 23, 2023. D5555 IMMUNOHEMATOLOGY 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. -- 3 of 5 -- This STANDARD is not met as evidenced by: Based on a review of procedures, blood bank records, and an interview with the technical supervisor (TS) #1, the laboratory failed to perform and document quarterly alarm checks to ensure storage conditions for four of four Red Blood Cells (RBCs) units are properly monitored from January 1, 2023, to March 5, 2024, for one Helmer Refrigerator. Findings: 1. A review of the "Blood Bank Temperature and Maintenance Log" lacked documentation of quarterly maintenance of their Helmer refrigerator's alarm system for the year 2023, as required by their "Helmer Refrigerator Maintenance" procedure to ensure the proper monitoring of the storage temperature of two group O Rh(D)-negative and two group O Rh(D)-positive Red Blood Cells (RBCs) units maintained in inventory. 2. An interview with TS #1 on August 29, 2024, at 1:30 PM confirmed the laboratory failed to perform and document quarterly alarm checks from January 1, 2023, to March 5, 2024. 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, procedures, and an interview with technical supervisor (TS) #1, the laboratory failed to perform comparison studies twice a year and define the relationship between the test results using two different chemistry analyzers and manual and automated differential blood count from August 29, 2022, to August 29, 2024. Findings: 1. No comparison studies between the Siemens Dimension EXL 200 and Abbott i-STAT for the analytes: sodium, potassium, chloride, ionized calcium, total CO (2), glucose, blood urea nitrogen (BUN), and creatinine were available for review. 2. No comparison studies between manual differential blood count and automated differential blood count performed on the Sysmex XS 1000i were available for review. 3. No procedures for comparison studies to include a written criteria for acceptable differences in test values for chemistry and differential blood count were available for review. 4. An interview with TS #1 on August 29, 2024, at 10:30 AM confirmed the laboratory failed to perform comparison studies twice a year and define the relationship between the test results between two chemistry analyzers (Siemens Dimension EXL 200 and Abbott i-STAT) and manual and automated differential blood count from August 29, 2022, to August 29, 2024. 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 immunohematology record review, policy and procedures, and an interview -- 4 of 5 -- with the technical supervisor (TS) #1, the laboratory director (LD) #1 failed to ensure that the quality assessment program was maintained and effectively monitored by laboratory staff from August 29, 2022, to August 29, 2024. Findings: 1. The laboratory director failed to follow the Grifols DG Gel 8 Quality Control procedure to review and sign the DG Gel Essential Control Logs and failed to follow the Grifols DG Gel 8 Manual System Maintenance procedure to review and sign the Blood Bank Temperature and Maintenance Log to ensure staff are performing duties as assigned. 2. The laboratory director failed to ensure the laboratory manager follow the "Blood Bank Documentation and Review" procedure to perform monthly reviews of blood bank records and provide those documents for quarterly review to the laboratory director. 3. The laboratory director failed to ensure staff do not use expired blood bank reagents and staff performed quarterly blood bank alarm check and DG Gel 8 maintenance (refer to D5417, D5431 and D5555). 4. An interview with TS #1 on August 29, 2024, at 4:39 PM confirmed the laboratory failed to ensure laboratory staff maintained the quality assurance program of the above-listed items from August 29, 2022, to August 29, 2024. -- 5 of 5 --

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 procedure manual, and interview with Technical Supervisor (TS) #1, the laboratory failed to establish and follow procedures for certifying one of one microscope and fume hood for accuracy. Findings: 1. Observed one microscope located in the laboratory. No certification stickers or records were available for review for years 2021 and 2022. 2. Review of Test Volume Report revealed three KOH preps, four Wet preps, and 15 microscopic uranalysis were performed using the microscope from November 29, 2021 to November 29 2022 (12 months). 3. Observed one fume hood in the laboratory with a function check sticker labeled "next service date 5/6/21". No other function check sticker or certification records were available for review from May 6, 2021, to November 29, 2022. 4. Review of "Quality Assurance" policy revealed the laboratory failed to define the type and frequency of the microscope and fume hood certification and failed to follow the policy to obtain "documentation of preventative maintenance, periodic inspections, and testing for proper operation of equipment and instruments." 5. Interview with TS #1 on November 29, 2022, at 1:30 PM, confirmed the laboratory failed to have the microscope and hood certified for accuracy. 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 -- 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, policy and procedures, and interview with the Technical Supervisor (TS) #1, the laboratory failed to perform monthly external quality controls (QC) as required by their Individualized Quality Control Plan (IQCP) for four out of twelve months in 2021. Findings: 1. Review of Quality Control procedure revealed the laboratory failed to follow their procedure as stated, "Liquid QC will be performed monthly, per IQCP" for the Alere Triage. 2. Review of Quality Control Worksheet for the Triage Ddimer revealed the laboratory failed to perform "External Quality Control: Positive and Negative QC each new lot and each new shipment, every 30 days", 3. A record review of external liquid QC checks for Ddimer lacked both a positive and negative QC check for June, July, September, and November of 2021. 5. Interview with the TS #1 on November 29, 2022, at 3:00 PM, confirmed the laboratory failed to perform external liquid QC monthly as required by their Triage Ddimer IQCP for June, July, September, and November of 2021. D5553 IMMUNOHEMATOLOGY CFR(s): 493.1271(b)(f) (b) Immunohematological testing and distribution of blood and blood products. Blood and blood product testing and distribution must comply with 21 CFR 606.100(b)(12); 606.160(b)(3)(ii) and (b)(3)(v); 610.40; 640.5(a), (b), (c), and (e); and 640.11(b). (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 review of policy and procedures, records, and interview with Technical Supervisor (TS) #1, the laboratory failed to document visual inspection checks for blood units released for transfusion from January 01, 2021, to July 26, 2022. Findings: 1. Review of "Release of Blood Product" procedure revealed the laboratory failed to document visual inspections performed, as stated "3. Both check out staff will inspect the blood unit for any leaks, clots, clumps, discoloration, or signs of contamination" 2. Review of "Blood Bank Record" lacked visual inspection documentation for blood units released for transfusion from January 1, 2021 to July 26, 2022. 3. Interview with TS #1 on November 29, 2022, at 11:00 AM, confirmed the lack of visual inspection documentation on the Blood Bank Records for blood units released from January 01, 2021, to July 26, 2022. -- 2 of 2 --

Summary Statement of Deficiencies 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 review of chemistry, hematology, and blood bank procedures, the laboratory failed to include normal values for complete blood counts, microscopic urinalysis and failed to have a step-by-step procedure for review of historical blood bank testing (refer to D5403); failed to perform regular blood bank alarm checks (refer to D5555) and failed to establish or verify the criteria for acceptability of all control materials (refer to D5469). 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 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 -- 493.1253. (7) Control procedures. (8)

Summary Statement of Deficiencies D0000 Based on an off-site proficiency testing desk review conducted on 9/30/2020, deficiencies were cited for Ruby Valley Hospital DBA Ruby Valley Medical Ctr in Sheridan, 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 white blood cell differentials (WBC Diff) for four of seven events (2018 event 2, 2019 event 1 and 3, 2020 event 2), resulting in unsuccessful proficiency testing performance. See D2130 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 -- 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 review of proficiency testing scores and interview, the laboratory failed to achieve a score of 80 percent for WBC Diff in four of seven events (2018 event 2, 2019 event 1 and 3, 2020 event 2), resulting in unsuccessful performance. The findings include: 1. Review of CMS 2567 with Conditions Out-First Unsuccessful PT Performance dated May 14, 2019 addressed to Dr. Shannon on 9/30/2020. 2. Review of CMS-153 Unsuccessful Proficiency Testing Report on 9/30/20 at 10:30 a.m. which included Ruby Valley Hospital DBA Ruby Valley Medical Ctr with unsuccessful proficiency testing scores for WBC Diff. 3. Review of the CMS-155 report on 9/30/20 at 10:30 a.m., revealed the American Proficiency Institute (API) WBC Diff scores for 2019 event 3 was 60% and 2020 event 2 was 4%. 4. Confirmed by email communication with the laboratory manager, the laboratory had four of seven unsuccessful PT scores for WBC Diff. on 9/30/20 at 10:52 a.m. D6000 MODERATE COMPLEXITY LABORATORY DIRECTOR CFR(s): 493.1403 The laboratory must have a director who meets the qualification requirements of 493. 1405 of this subpart and provides overall management and direction in accordance with 493.1407 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 WBC Diff. See D6020. D6020 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(5) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(5) Ensure that the quality control program is established and maintained to assure the quality of laboratory services provided. This STANDARD is not met as evidenced by: Based on review of Proficiency Testing (PT) scores and interview, the Laboratory Director failed to ensure the quality assessment (QA) program was adequate and maintained for correct data entry and submission of proficiency testing results for Hematology, WBC Diff. The findings include: 1. Review of CMS 2567 with Conditions Out-First Unsuccessful PT Performance dated May 14, 2019 addressed to -- 2 of 3 -- Dr. Shannon on 9/30/2020. 2. Review of the CMS-153 Unsuccessful Proficiency Testing Report on 5/14/19 at 7:06 a.m. and 9/30/20 which included Ruby Valley Hospital DBA Ruby Valley Medical Ctr with unsuccessful proficiency testing scores for WBC Diff. 3. Review of the CMS-155 report on 5/14/19 at 7:35 a.m., the American Proficiency Institute (API) WBC Diff score for 2018 event 2 was 20% and 2019 event 1 was 0%. 4. Review of the CMS-155 report on 9/30/20 at 10:30 a.m., the American Proficiency Institute (API) WBC Diff score for 2019 event 3 was 60% and 2020 event 2 was 4%. 5. The laboratory manager confirmed on 9/30/20 at 10:52 a.m., "The instructions state to make sure the Caps Lock is off, which the operator interpreted this to mean lower-case characters were to be used when entering the sample IDs. Sysmex reports that this changes the algorithm used by the instrument in calculating results (and why our numbers were incorrect." -- 3 of 3 --

Summary Statement of Deficiencies D0000 Based on an off-site proficiency testing desk review conducted on 5/14/19, deficiencies were cited for Ruby Valley Hospital DBA Ruby Valley Medical Ctr in Sheridan, 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 white blood cell differentials (WBC Diff) for two of three events (2018 event 2 and 2019 event 1), resulting in unsuccessful proficiency testing performance. See D2130. 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 -- 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 review of proficiency testing scores and interview, the laboratory failed to achieve a score of 80 percent for WBC Diff in two of three events in 2019, resulting in unsuccessful performance. The findings include: 1. During a review on 5/14/19 at 7: 06 a.m. of the CMS-153 Unsuccessful Proficiency Testing Report included Ruby Valley Hospital DBA Ruby Valley Medical Ctr with unsuccessful proficiency testing scores for WBC Diff. 2. During a review on 5/14/19 at 7:35 a.m. of the CMS-155 report, the American Proficiency Institute (API) WBC Diff score for event 2 of 2018 was 20%. 3. During a review on 5/14/19 at 7:35 a.m. of the CMS-155 report, the API WBC Diff score for event 1 of 2019 was 0%. 4. On 5/14/19 at 10:30 a.m., the laboratory manager stated the analyzer reported errors for 2018 event 2 and results were not submitted on time for 2019 event 1. -- 2 of 2 --

Summary Statement of Deficiencies D0000 Based on an on-site recertification survey conducted on 5/8/18, deficiencies were cited for Ruby Valley Hospital in Sheridan, MT. 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. This STANDARD is not met as evidenced by: Based on record review and interview, the laboratory failed to include the address of the laboratory location where the test was performed for analytes performed on the Siemens Dimension analyzer from 8/27/16 to 5/8/18. The findings include: 1. A review on 5/8/17 at 12:00 p.m. of test reports for analytes performed on the Siemens Dimension analyzer lacked an address of the laboratory location where the test was performed. a. Digoxin, acetaminophen, sodium, potassium, chloride, glucose, blood urea nitrogen, creatinine, calcium, alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase, total bilirubin, albumin, enzymatic carbonate, triglycerides, thyroid stimulating hormone, cholesterol, low density lipoprotein cholesterol, total protein, high density lipoprotein cholesterol, prostate specific antigen, and C-reactive protein. 2. On 5/8/18 at 4:00 p.m., staff member A stated the address can be added into the Siemens Dimension analyzer to print the name. D6128 TECHNICAL SUPERVISOR RESPONSIBILITIES 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 -- 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. 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 two of two testing personnel from 8/27 /16 to 5/8/18. The findings include: 1. On 5/8/18 at 8:45 a.m., staff member A stated there were no documented competencies due to only having two full time testing personnel. The personnel perform proficiency testing to prove competency. 2. A review on 5/8/18 at 10:30 a.m. of the competency assessments and proficiency testing documentation lacked documented annual competency assessments for two of two testing personnel. -- 2 of 2 --