Moab Regional Hospital

Summary Statement of Deficiencies D5807 TEST REPORT CFR(s): 493.1291(d) Pertinent "reference intervals" or "normal" values, as determined by the laboratory performing the tests, must be available to the authorized person who ordered the tests and, if applicable, the individual responsible for using the test results. This STANDARD is not met as evidenced by: Based on a review of patient test reports, laboratory procedure manual, and an interview with Personnel #2, the laboratory failed to include the correct normal ranges for D Dimer. Findings: 1. Review of patient reports revealed the D Dimer reference range did not correctly match the reference range for D Dimer in "The D-Dimer- Sysmex CS-2500" procedure manual. 2. The procedure manual showed the D Dimer reference interval was 0.00-0.45 mg/L 3. The patient report showed the D Dimer reference interval was 0.00-0.53 mg/L 4. Confirmed during interview with Personnel #2 at approximately 4:28 PM on July 25, 2024. D6107 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(15) The laboratory director must specify, in writing, the responsibilities and duties of each consultant and each supervisor, as well as each person engaged in the performance of the preanalytic, analytic, and postanalytic phases of testing, that identifies which examinations and procedures each individual is authorized to perform, whether supervision is required for specimen processing, test performance or result reporting and whether supervisory or director review is required prior to reporting patient test results. This STANDARD is not met as evidenced by: 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 -- Based on record review and interview, the laboratory director failed to delegate, in writing, the duties and responsibilities to each person involved in all phases of the testing process. Findings: 1. Review of the "Laboratory Director's Delegation of Duties" procedure states,"The Laboratory Director has delegated the following duties to the Laboratory Manager/Supervisor and/or the Technical Consultant, as he/she deems appropriate." And "The Laboratory Director has delegated the following duties to the Testing Personnel, including Laboratory Supervisor and Technical Consultant:" 2. No written delegations were available for 8 of 8 personnel reviewed. 3. The "Laboratory Director's Delegation of Duties" procedure presented during the time of the survey failed to include each person involved in all phases of the testing process, and their respective responsibilities. 4. Confirmed during interview with Personnel #2 and #3 at approximately 4:28 PM on July 25, 2024. 5. The laboratory performed approximately 220,067 test annually. -- 2 of 2 --

Summary Statement of Deficiencies 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: Based on a review of Standard Operating Procedures (SOP), instrument maintenance logs, and an interview with the Lab Supervisor, the laboratory failed to document performance of monthly function checks established for the Renok Rehydrator unit to verify the dispensed volume, for 4 of 12 months reviewed from August 2021 - August 2022. The Renok Rehydrator is used to simultaneously rehydrate and inoculate MicroScan panels for the identification and antimicrobial susceptibility testing of bacteria isolated from a microbiology culture. Findings include: 1. In the laboratory SOP titled, "Maintenance of Renok," it states: "The RENOK unit dispense volume is checked on a monthly basis." 2. A review of the monthly MicroScan Instrument Maintenance Checklist, at approximately 11:30 AM on 9/7/22, revealed that the monthly maintenance item listed for "Check Renok Dispense Volume" was not documented for January, March, July, and August of 2022. 3. An interview with the Lab Supervisor, at approximately 11:40 AM on 9/7/22, confirmed that the monthly maintenance item listed for "Check Renok Dispense Volume" was not documented for January, March, July, and August of 2022. 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 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 -- 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 laboratory record review and interview with the general supervisor (GS), the laboratory failed to ensure the twice a year evaluation of two coagulation analyzers (Sysmex CA-600 series and Sysmex CS-2500 series) and two hematology analyzers (Sysmex XN-350 and Sysmex XN-550) that compared the relationship between instruments. The laboratory performs approximately 49,000 hematology tests annually. Findings include: 1. The laboratory quality assessment procedure failed to include a system that twice a year evaluates and defines the relationship between test results using different instruments. 2. The laboratory records review failed to include instrument to instrument comparison. 3. In an interview conducted on 09/07/2022 at 9: 20 AM, the GS stated the laboratory did not have a system in place that twice a year evaluates and defines the relationship between test results using different instruments. D5807 TEST REPORT CFR(s): 493.1291(d) Pertinent "reference intervals" or "normal" values, as determined by the laboratory performing the tests, must be available to the authorized person who ordered the tests and, if applicable, the individual responsible for using the test results. This STANDARD is not met as evidenced by: Based on a review of patient test reports, laboratory procedure manual, and an interview with the general supervisor (GS), the laboratory failed to include the correct normal ranges for chemistry and hematology analytes. Findings include: 1. Review of the patient reports revealed nine female ranges and six male ranges did not correctly match those reference ranges for the chemistry and hematology in the procedure manual. 2. The procedure manual showed: Parameter Reference Range Troponin 0.0 - 0.056 (male and female) Vancomycin, Trough 5 - 10 (female) Alanine Transaminase 30 - 65 (female) Alkaline Phosphatase 50 - 136 (female) White Blood Count 4.00 - 10.50 (male) Red Blood Count 4.00 - 6.00 (female) Hemoglobin 13.5 - 18.0 (male and female) Hematocrit 40.0 - 54.0 (male and female) Red Cell Distribution Width 11.5 -17.5 (female) # Basophils 0.2 - 1.0 (male and female) # Immature Granulocytes 0 - 1.0 (male and female) 3. The patient report showed: Parameter Reference Range Troponin 0.0 - 34.0 (female) & 0.0 - 53.0 (male) Vancomycin, Trough 10.0 - 20.0 (female) Alanine Transaminase 12 - 78 (female) Alkaline Phosphatase 46 - 116 (female) White Blood Count 4.00 - 12.00 (male) Red Blood Count 3.50 - 5.80 (female) Hemoglobin 11.5 - 16.0 (female) & 13.0 -16.0 (male) Hematocrit 37.0 - 47.0 (female) & 36.0 - 50.0 (male) Red Cell Distribution Width 11.5 -14.5 (female) # Basophils 0.0 - 0.1 (male and female) # Immature Granulocytes 0.0 - 0.1 (male and female) 4. In an interview on 09/07/2022 at 3:00 PM, the GS confirmed the lab failed to provide pertinent normal ranges on the test report. D6127 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 -- 2 of 3 -- semiannually during the first year the individual tests patient specimens. This STANDARD is not met as evidenced by: Based on record review and interview with the General Supervisor (GS), the laboratory failed to evaluate the performance at least twice during the first year testing personal (TP) performed patient testing in the specialties of microbiology, chemistry, hematology, and immunohematology. Findings include: 1. Record review revealed that 2 of 7 TP were not evaluated at least two times during the first year the TP performed patient testing. 2. The in an interview on 09/07/2022 at 10:20 AM with the General Supervisor, it was confirmed that 2 of 7 TP did not receive competency assessment at least two times during their first year of patient testing. -- 3 of 3 --

Summary Statement of Deficiencies D6102 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(12) The laboratory director must ensure that prior to testing patients' specimens, all personnel have the appropriate education and experience, receive the appropriate training for the type and complexity of the services offered, and have demonstrated that they can perform all testing operations reliably to provide and report accurate results. This STANDARD is not met as evidenced by: Based on personnel record review, training record review, and interview with staff, the laboratory director failed to ensure that training and competency assessment was completed for testing personnel prior to testing patients' specimens for 1 of 2 new testing personnel in Bacteriology. The laboratory peforms approximately 20 Bacteriology tests per week. Findings include: 1. Personnel record review for testing personnel F included incomplete training and competency records for Bacteriology. 2. Personnel record review for testing personnel F included partial training completed and signed off by personnel G. Test personnel G lacked documentation to qualify as a technical consultant or supervisor authorized to evaluate training completion or competency. 3. Personnel record review for testing personnel F included a written warning dated 2/25/20 citing incorrect isolation techniques and improper workup of a urine culture on a patient specimen dated 2/18/20. 4. Personnel record review for testing personnel F included 4 written warnings dated 2/25/20 for improper processing and workup of Bacteriology patient specimens. In an interview with the Technical Supervisor on 9/21/20 at approximately 2:30 pm the Technical Supervisor stated that testing personnel F did not perform any laboratory testing alone. D6168 TESTING PERSONNEL CFR(s): 493.1487 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 -- The laboratory has a sufficient number of individuals who meet the qualification requirements of 493.1489 of this subpart to perform the functions specified in 493. 1495 of this subpart for the volume and complexity of testing performed. This CONDITION is not met as evidenced by: Based on lack of documentation, patient test records review, and confirmation by staff, 2 of 2 new testing personnel records review failed to include educational benchmarks to qualify as moderate complexity testing personnel. (See D6171) D6171 TESTING PERSONNEL QUALIFICATIONS CFR(s): 493.1489(b) (b) Meet one of the following requirements: (b)(1) Be a doctor of medicine, doctor of osteopathy, or doctor of podiatric medicine licensed to practice medicine, osteopathy, or podiatry in the State in which the laboratory is located or have earned a doctoral, master's or bachelor's degree in a chemical, physical, biological or clinical laboratory science, or medical technology from an accredited institution; (b)(2)(i) Have earned an associate degree in a laboratory science, or medical laboratory technology from an accredited institution or-- (b)(2)(ii) Have education and training equivalent to that specified in paragraph (b)(2)(i) of this section that includes-- (b)(2)(ii)(A) At least 60 semester hours, or equivalent, from an accredited institution that, at a minimum, include either-- (b)(2)(ii)(A)(1) 24 semester hours of medical laboratory technology courses; or (b)(2)(ii)(A)(2) 24 semester hours of science courses that include-- (b)(2) (ii)(A)(2)(i) Six semester hours of chemistry; (b)(2)(ii)(A)(2)(ii) Six semester hours of biology; and (b)(2)(ii)(A)(2)(iii) Twelve semester hours of chemistry, biology, or medical laboratory technology in any combination; and (b)(2)(ii)(B) Have laboratory training that includes either of the following: (b)(2)(ii)(B)(1) Completion of a clinical laboratory training program approved or accredited by the ABHES, the CAHEA, or other organization approved by HHS. (This training may be included in the 60 semester hours listed in paragraph (b)(2)(ii)(A) of this section.) (b)(2)(ii)(B)(2) At least 3 months documented laboratory training in each specialty in which the individual performs high complexity testing. (b)(3) Have previously qualified or could have qualified as a technologist under 493.1491 on or before February 28, 1992; (b) (4) On or before April 24, 1995 be a high school graduate or equivalent and have either-- (b)(4)(i) Graduated from a medical laboratory or clinical laboratory training program approved or accredited by ABHES, CAHEA, or other organization approved by HHS; or (b)(4)(ii) Successfully completed an official U.S. military medical laboratory procedures training course of at least 50 weeks duration and have held the military enlisted occupational specialty of Medical Laboratory Specialist (Laboratory Technician); (b)(5)(i) Until September 1, 1997-- (b)(5)(i)(A) Have earned a high school diploma or equivalent; and (b)(5)(i)(B) Have documentation of training appropriate for the testing performed before analyzing patient specimens. Such training must ensure that the individual has-- (b)(5)(i)(B)(1) The skills required for proper specimen collection, including patient preparation, if applicable, labeling, handling, preservation or fixation, processing or preparation, transportation and storage of specimens; (b)(5)(i)(B)(2) The skills required for implementing all standard laboratory procedures; (b)(5)(i)(B)(3) The skills required for performing each test method and for proper instrument use; (b)(5)(i)(B)(4) The skills required for performing preventive maintenance, troubleshooting, and calibration procedures related to each test performed; (b)(5)(i)(B)(5) A working knowledge of reagent stability and storage; (b)(5)(i)(B)(6) The skills required to implement the quality control policies and procedures of the laboratory; (b)(5)(i)(B)(7) An awareness of the -- 2 of 3 -- factors that influence test results; and (b)(5)(i)(B)(8) The skills required to assess and verify the validity of patient test results through the evaluation of quality control values before reporting patient test results; and (b)(5)(i)(B)(8)(ii) As of September 1, 1997, be qualified under 493.1489(b)(1), (b)(2), or (b)(4), except for those individuals qualified under paragraph (b)(5)(i) of this section who were performing high complexity testing on or before April 24, 1995; (b)(6) For blood gas analysis-- (b)(6) (i) Be qualified under 493.1489(b)(1), (b)(2), (b)(3), (b)(4), or (b)(5); (b)(6)(ii) Have earned a bachelor's degree in respiratory therapy or cardiovascular technology from an accredited institution; or (b)(6)(iii) Have earned an associate degree related to pulmonary function from an accredited institution; or (b)(7) For histopathology, meet the qualifications of 493.1449 (b) or (l) to perform tissue examinations. This STANDARD is not met as evidenced by: Based on personnel records review, lack of documentation and confirmation by staff, 2 of 4 high competency testing personnel lacked documentation of educational credentials to qualify to perform high complexity testing in Microbiology and Immunohematology. Findings include: 1. Personnel records review showed testing persons B and D lacked education documentation to qualify as a high complexity testing personnel. 2. In an interview conducted on 09/21/2020 at approximately 3:15 P. M. the laboratory manager confirmed testing personnel B and D did not have education documentation present in the laboratory personnel record system. D6175 TESTING PERSONNEL RESPONSIBILITIES CFR(s): 493.1495(b)(1) Each individual performing high complexity testing must follow the laboratory's procedures for specimen handling and processing, test analyses, reporting and maintaining records of patient test results. This STANDARD is not met as evidenced by: Based on immunohematology test records review, immunohematology procedure review and confirmation by staff, laboratory testing personnel failed to follow laboratory instructions to perform compatibility testing for 2 of 47compatiblity tests reviewed from January 2, 2020 to February 12, 2020. Findings include: 1. Immunohematology test record review failed to include documentation the laboratory performed an immediate spin cross match for compatibility testing on 02/03/2020 for patient #2781 previously tested on 02/01/2020 patient ID #2002020030 and for patient # 2002140119 on 02/14/2020 . 2. Immunohematology procedure manual review included instruction s to perform an immediate spin cross match for compatibility. 3. In an interview conducted on 09/21/2020 at approximately 2:50 P M. the Laboratory manger confirmed the laboratory procedure included instructions for staff to perform immediate spin cross match. -- 3 of 3 --

Summary Statement of Deficiencies 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 patient test records review and interview with the laboratory manager and general supervisor for immunohematology, the laboratory procedure failed to ensure they followed requirments to follow manufacturer's and Federal Food and Drug Administration (FDA) instructions to include an antibody screen for IgG antibody detection and an immediate spin crossmatch step for IgM antibody detection for patients that are being crossmatched for red blood cell compatibility. The labortory performed approximately 5 crosmatches per month. No cross matches were observed that included a positive antibody screen between May 2017 and May 2019. Findings include: 1. Patient test records review failed to include documentation the laboratory performed antibody screen plus an immediate spin cross match for patient logged as MRN#9432 on 08/27/2017. The laboratory performed the crossmatch but failed to document the antibody screen was performed. 2. The laboratory procedure manual failed to include the inclusion of an immediate spin crossmatch step for patients with a previously identified positive antibody screen or currently testing positive for an antibody screen. 3. In an interview conducted on 05/14/2019 at approximately 10:00 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 -- A.M. the laboratory manager stated the actual laboratory process was to perform an immediate spin crossmatch for patients with a negative antibody screen but proceded to an IgG only crossmatch (immediate spin is not performed) for patients that have a positive antibody screen or had a previously identified antibody. The MTS manufacturer has updated their procedure to include the FDA requirement to ensure compatibility is confirmed for IgM (immedicate spin crossmatch as well as IgG (via an indirect Coombs procedure) antibody presence detection. 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 patient test reports review and confirmation by the laboratory manger, three of three histopathology test reports reviewed failed to include the location for where frozen section tests were performed. Findings include: 1. Patient test reports for patients S17-2877, S18-0957, and S19-6632 failed to include the location for where testing was performed. 2. In an interview conducted on 05/13/2019 at approximately 5: 45 P.M. the laboratory manager confirmed the test reports did not include the location where frozen section tests were performed -- 2 of 2 --