Idaho Falls Community Hospital

Summary Statement of Deficiencies D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on a review of the Centers for Medicare and Medicaid Services (CMS) 209 personnel form, laboratory procedures, training and competency assessment records and an interview with the laboratory manager on 9/10/2024, the laboratory failed to follow written policies and procedures to assess testing personnel competency in 2023 and 2024. The findings include: 1. The CMS 209 identified 104 testing personnel (TP) performing moderate complexity testing of which 55 were new since the last inspection on 7/11/2022. 2. A review of laboratory procedures identified that the laboratory established policies and procedures to assess TP initial training, semiannual and annual competency. 3. A review of training and competency assessment records identified that the laboratory failed to have initial training for six (6) of 55 new TP. 4. A review of training and competency assessment records identified that the laboratory failed to have six month competency assessments for six (6) TP. 5. A review of training and competency assessment records identified that the laboratory failed to have annual competency assessments for seven (7) TP in 2023 and two (2) TP in 2024. 6. An interview with the laboratory manager on 9/10/2024 at 9:40 am confirmed the above findings. 7. The laboratory reports performing 10,085 moderate complexity tests annually. 8. This is a repeat deficiency from the previous inspections on 11/6/2020 and 7/11/2022. The laboratory failed to implement and follow their

Summary Statement of Deficiencies D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on a review of the Centers for Medicare and Medicaid Services (CMS) 209 personnel form, training and competency assessment records and an interview with the laboratory manager on 7/11/2022, the laboratory failed to follow written policies and procedures to assess testing personnel training and competency in 2021 and 2022. The findings include: 1. The CMS 209 identified 112 testing personnel performing moderate complexity testing. 2. A review of training and competency assessment records identified eleven (11) of 51 testing personnel hired after the last inspection (11 /6/2020) that failed to have documentation of initial training. 3. A review of training and competency assessment records identified six (6) of 61 testing personnel that failed to have an annual competency assessment for 2021. 4. An interview with the laboratory manager on 7/11/2022 at 2:28 pm confirmed the above findings. 5. The laboratory reports performing 7842 tests annually. 6. This is a repeat deficiency from the last inspection (11/6/2020). D6033 TECHNICAL CONSULTANT-MODERATE COMPEXITY CFR(s): 493.1409 The laboratory must have a technical consultant who meets the qualification requirements of 493.1411 of this subpart and provides technical oversight in accordance with 493.1413 of this subpart. 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 -- This CONDITION is not met as evidenced by: Based on a review of the Centers for Medicare and Medicaid Services (CMS) 209 personnel form, educational documents and an interview with the laboratory manager on 7/11/2022, the laboratory failed to have a technical consultant that qualified with the minimum educational requirements. See D6035 D6035 TECHNICAL CONSULTANT QUALIFICATIONS CFR(s): 493.1411 (a) The technical consultant must be qualified and must possess a current license issued by the State in which the laboratory is located, if such licensing is required. (b) The technical consultant must-- (b)(1)(i) Be a doctor of medicine or doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located; and (b)(1)(ii) Be certified in anatomic or clinical pathology, or both, by the American Board of Pathology or the American Osteopathic Board of Pathology or possess qualifications that are equivalent to those required for such certification; or (b)(2)(i) 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; and (b)(2)(ii) Have at least one year of laboratory training or experience, or both in non-waived testing, in the designated specialty or subspecialty areas of service for which the technical consultant is responsible (for example, physicians certified either in hematology or hematology and medical oncology by the American Board of Internal Medicine are qualified to serve as the technical consultant in hematology); or (b)(3)(i) Hold an earned doctoral or master's degree in a chemical, physical, biological or clinical laboratory science or medical technology from an accredited institution; and (b)(3)(ii) Have at least one year of laboratory training or experience, or both in non-waived testing, in the designated specialty or subspecialty areas of service for which the technical consultant is responsible; or (b)(4)(i) Have earned a bachelor's degree in a chemical, physical or biological science or medical technology from an accredited institution; and (b)(4)(ii) Have at least 2 years of laboratory training or experience, or both in non-waived testing, in the designated specialty or subspecialty areas of service for which the technical consultant is responsible. Note: The technical consultant requirements for "laboratory training or experience, or both" in each specialty or subspecialty may be acquired concurrently in more than one of the specialties or subspecialties of service, excluding waived tests. For example, an individual who has a bachelor's degree in biology and additionally has documentation of 2 years of work experience performing tests of moderate complexity in all specialties and subspecialties of service, would be qualified as a technical consultant in a laboratory performing moderate complexity testing in all specialties and subspecialties of service. This STANDARD is not met as evidenced by: Based on a review of the Centers for Medicare and Medicaid Services (CMS) 209 personnel form, educational documents and and interview with the laboratory manager on 7/11/2022, the laboratory failed to have a qualified technical consultant. The finding include: 1. A review of educational documents for the person listed as technical consultant on the CMS 209 identified that the laboratory failed to hire a technical consultant with a bachelor's degree in chemical, physical, biological science or medical technology. 2. An interview with the laboratory manager on 7/11/2022 at 1: 15 pm confirmed that the technical consultant failed to have bachelor's degree in chemical, physical, biological science or medical technology. 3. The laboratory reports performing 7842 tests annually. -- 2 of 3 -- D6063 LABORATORY TESTING PERSONNEL CFR(s): 493.1421 The laboratory must have a sufficient number of individuals who meet the qualification requirements of 493.1423, to perform the functions specified in 493. 1425 for the volume and complexity of tests performed. This CONDITION is not met as evidenced by: Based on a review of the Centers for Medicare and Medicaid Services (CMS) 209 personnel form, educational documents and and interview with the laboratory manager on 7/11/2022, the laboratory failed to have two (2) of 51 new testing personnel qualified with the minimum educational requirements. See D6065 D6065 TESTING PERSONNEL QUALIFICATIONS CFR(s): 493.1423(b)(1)(2)(3)(4)(i) (b) Meet one of the following requirements: (b)(1) Be a doctor of medicine or doctor of osteopathy licensed to practice medicine or osteopathy 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; or (b)(2) Have earned an associate degree in a chemical, physical or biological science or medical laboratory technology from an accredited institution; or (b)(3) Be a high school graduate or equivalent and have successfully completed an official military medical laboratory procedures course of at least 50 weeks duration and have held the military enlisted occupational specialty of Medical Laboratory Specialist (Laboratory Technician); or (b)(4)(i) Have earned a high school diploma or equivalent; and This STANDARD is not met as evidenced by: Based on a review of the Centers for Medicare and Medicaid Services (CMS) 209 personnel form, educational documents and and interview with the laboratory manager on 7/11/2022, the laboratory failed to ensure that all testing personnel meet the educational requirements for testing. The findings include: 1. A review of the CMS 209 identified 51 new testing personnel since the last survey on 11/6/2020. 2. A review of educational documents for the 51 new testing personnel identified that the laboratory failed to have educational documentation for two (2) testing personnel showing that they met the minimum educational requirements before performing patient testing. 3. An interview with the laboratory manager on 7/11/2022 at 3:00 pm confirmed the above finding. 4. The laboratory reports performing 7842 tests annually. -- 3 of 3 --

Summary Statement of Deficiencies D2007 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The samples must be examined or tested with the laboratory's regular patient workload by personnel who routinely perform the testing in the laboratory, using the laboratory's routine methods This STANDARD is not met as evidenced by: Based on record review of the laboratory's proficiency testing (PT) attestation records from the American Proficiency Institute (API) and interview with the laboratory Technical Consultant (TC) on 11/6/2020 at 09:30 a.m., the laboratory failed to test their blood gas proficiency testing (PT) samples to be examined or tested with the laboratory's regular patient workload by personnel who routinely perform the testing in the laboratory. The findings include: 1. The laboratory is responsible for nine (9) ABX blood gas analyzers that are located in the nursing units in the Catherization lab (2), the general surgery department(1), the emergency room (2), the med-surge department, and the Intensive Care unit (2), general laboratory. 2. The personnel who routinely perform the blood gas analysis are the nursing staff in each department (146). 3. Review of the College of American Pathologists (CAP) PT attestation sheets revealed that the technical consultant (TC) performed the blood gas and hematology for event 1 of 2020, the TC performed the all five specimens for hematology event 2 of 2020, and 2/5 of the PT specimens of the Blood gas PT in event 2 of 2020, and the TC performed 2 of 5 blood gas specimens for event 3 of 2020. Only five (5) of the 146 testing personnel performed the blood gas PT during the PT testing year of 2020. The TC does not routinely perform blood gas analysis. 4. The laboratory technical consultant and laboratory director confirmed by interview on 11/6/2020 at 10:15 a.m., the technical consultant did not routinely perform the blood gas analysis. 5. The laboratory reports performing 1700 blood gas patient specimens annually. D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES 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 -- 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 review of the laboratory's Policy's and Procedures and interview with the laboratory technical consultant (TC) on 11/06/2020, the laboratory failed to establish and follow written policies and procedures to assess employee and consultant competency. in accordance with 42 C.F.R. 493.1413(b)(8)(9). The findings include: 1. The laboratory personnel form (CMS-209) lists (142) testing personnel who are high school graduates or higher degreed individuals. 2. The laboratory had no documentation of initial training or competency for 7 of the 142 testing personnel listed on the CMS-209. 3. The laboratory had no documentation of semi-annual competency for 104 of the 142 testing personnel listed on the CMS-209. 4. The laboratory had no documentation of annual competency for 15 of the 142 testing personnel listed on the CMS-209. 5. The laboratory had a check list sheet that does not indicate or identify which of the six parameters listed in 42 C.F.R. 493.1413(b)(8) were used to determine competency for initial, semi-annual or annual competency. 6. The technical consultant confirmed by interview on 11/06/2020 at 2:00 p.m. that the laboratory does not have a policy or procedure for initial training and competency, semi-annual competency or annual competency which include the six parameters listed in 42 C.F.R. 493.1413(b)(8). (i) Direct observations of routine patient test performance, including patient preparation, if applicable, specimen handling, processing and testing; (ii) Monitoring the recording and reporting of test results; (iii) Review of intermediate test results or worksheets, quality control records, proficiency testing results, and preventive maintenance records; (iv) Direct observation of performance of instrument maintenance and function checks; (v) Assessment of test performance through testing previously analyzed specimens, internal blind testing samples or external proficiency testing samples; and (vi) Assessment of problem solving skills 7. The laboratory has 142 testing personnel and reports performing 28,105 patient test annually. D5291 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(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 general laboratory systems requirements specified at 493.1231 through 493.1236. This STANDARD is not met as evidenced by: Based on review of the laboratory's polices and procedures, and interview with the laboratory director (LD) and the technical consultant (TC) on 11/6/2020, the laboratory failed to establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and, when indicated, correct problems identified in the general laboratory systems requirements specified at 493.1231 through 493.1236. The findings include: 1. The laboratory is responsible for Point of Care arterial blood gas (ABG) and Act Tdiff activated partial thromboplastin time (aPTT) testing by multiple hospital nursing department staff. 2. The LD and TC -- 2 of 5 -- confirmed by interview on 11/6/2020 at 3:00 p.m., the laboratory did not have policies and procedures to perform and document quality assessments (QA) for the POC testing performed by the hospital nursing staff. 3. The laboratory reports performing 25 aPTT tests and 1,700 ABG's annually D5411 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(a) Test systems must be selected by the laboratory. The testing must be performed following the manufacturer's instructions and in a manner that provides test results within the laboratory's stated performance specifications for each test system as determined under 493.1253. This STANDARD is not met as evidenced by: Based on review of the manufacturers manual for the Medtronic ACT diff, review of the laboratory's quality control logs and interview with the technical consultant (TC) on 11/6/2020, the laboratory failed to perform quality control (QC) testing following the manufacturer's instructions and in a manner that provides test results within the laboratory's stated performance specifications for the Medtronic ACT Diff activated partial thromboplastin time. The findings include: 1. The Medtronic ACT diff manual states that two external controls are to be ran each day of patient testing. The laboratory QC records revealed that the laboratory is performing two levels of external QC every seven days, and the electronic QC simulator is ran each day of patient testing testing. 2. The manufacturers manual specifically states that the electronic simulator may be used to enhance the QC program but "is not to replace the requirements of external controls". 3. The laboratory initiated an individual quality control plan (IQCP) to modify the requirements for the QC testing for the Medtronic ACT testing. The IQCP plan did not include precision studies for validating the IQCP. 4. The laboratory TC confirmed by interview on 11/6/2020 at 1:45 p.m., the laboratory did not have a complete IQCP for the Medtronic ACT testing and do not perform external QC each day of patient testing. 5. The laboratory reports performing 25 aPTT tests annually. 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 the laboratory's verification records for the Medtronic ACT point of care (POC) activated thromboplastin time (aPTT) and interview with the laboratory director (LD) and the technical consultant (TC) on 11/6/2020 at 11:55 a.m., the laboratory failed to demonstrate that it can obtain performance specifications by testing known positive and negative samples in order to verify the Medtronic ACT analyzers accuracy and precision. The findings include: 1. Review of the validation -- 3 of 5 -- and verification records performed on the Medtronic ACT POC analyzers revealed that the laboratory did not verify the manufacturer's specifications by testing known positive and negative samples to ensure that the expected results are obtained, but utilized the systems electronic simulator to verify precision data. 2. The laboratory director and the technical consultant confirmed by interview on 11/6/2020 at 1:30 p. m., the laboratory did not perform adequate precision studies to verify the Medtronic ACT POC analyzer. 3. The laboratory reports performing 23 ACT POC tests annually. 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 review of the Medtronic ACT activated platelet thromboplastin time (aPTT) manufacturers manual, review of the laboratory's quality control (QC) records and interview with the laboratory manager and the laboratory technical consultant on 11/6 /2020, the laboratory failed to 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. The findings include: 1. The laboratory performs external QC on the Medtronic ACT for aPTT every seven (7) days and the systems electronic simulator each day of testing in accordance with their developed individual quality control plan (IQCP). 2. The manufacturers manual states that the electronic simulator can be used to enhance the laboratory's QC program, but must not replace the use of external QC levels on each day of patient testing. See D5411. 3. The laboratory manager and the TC confirmed by interview on 11/6/2020 at 2:00 p.m., the laboratory's IQCP was not complete in establishing accuracy and precision, and that the laboratory has not been performing two external controls each day of patient testing for the ACT aPTT testing. 4. The laboratory reports performing 25 POC aPTT tests annually. 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 the manufacturers manual for the Medtronic ACT diff, review of -- 4 of 5 -- the laboratory's quality control logs and interview with the technical consultant (TC) on 11/6/2020, the laboratory director failed to ensure that the quality control program for the Medtronic ATC dif was established and maintained as stated by the manufacturer to assure the quality of laboratory services provided. The findings include: 1. The laboratory director failed to ensure that control procedures are performed using the number and frequency specified by the manufacturer or established by the laboratory when they meet or exceed the requirements as specified by the manufacturer. See D5445. D6021 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 quality assessment programs are established and maintained to assure the quality of laboratory services provided. This STANDARD is not met as evidenced by: Based on review of the laboratory's polices and procedures, and interview with the technical consultant (TC) on 11/6/2020, the laboratory director failed to ensure that quality assessment programs are established and maintained to assure the quality of laboratory services provided. 1. The laboratory director failed to establish and ensure written policies and procedures are available to assess and maintain the quality of laboratory services provided. See D5291 D6029 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(11) 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)(11) 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 laboratory testing personnel training and competency records and interview with the technical consultant on 11/6/2020, the laboratory director failed to ensure that prior to testing patients' specimens, all personnel have the appropriate education and experience, received 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. The findings include: 1. Based on review of the Centers for Medicare and Medicaid Services (CMS) laboratory personnel form (209), and interview with the technical consultant (TC) on 11/06 /2020, the laboratory director failed to ensure policy and procedures were developed to ensure all testing personnel had appropriate training and could demonstrate competency prior to testing patients' specimens. See D5209. -- 5 of 5 --