Minidoka Memorial Hospital

Summary Statement of Deficiencies D2016 SUCCESSFUL PARTICIPATION CFR(s): 493.803(a)(b)(c) (a) Each laboratory performing nonwaived testing must successfully participate in a proficiency testing program approved by CMS, if applicable, as described in subpart I of this part for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. (b) Except as specified in paragraph (c) of this section, if a laboratory fails to participate successfully in proficiency testing for a given specialty, subspecialty, analyte or test, as defined in this section, or fails to take remedial action when an individual fails gynecologic cytology, CMS imposes sanctions, as specified in subpart R of this part. (c) If a laboratory fails to perform successfully in a CMS- approved proficiency testing program, for the initial unsuccessful performance, CMS may direct the laboratory to undertake training of its personnel or to obtain technical assistance, or both, rather than imposing alternative or principle sanctions except when one or more of the following conditions exists: (1) There is immediate jeopardy to patient health and safety. (2) The laboratory fails to provide CMS or a CMS agent with satisfactory evidence that it has taken steps to correct the problem identified by the unsuccessful proficiency testing performance. (3) The laboratory has a poor compliance history. This CONDITION is not met as evidenced by: Based on a proficiency testing (PT) desk review of the Centers for Medicare and Medicaid (CMS) PT data report (Report 155D), graded results from the College of American Pathologists (CAP) and a telephone interview with the Laboratory Manager on 10/09/2024 at 11:14 AM, the laboratory failed to successfully participate in proficiency testing for Immunohematology Compatibility Testing 2 (two) out of 3 (three) events for 2024. Refer to D2181. D2181 COMPATIBILITY TESTING CFR(s): 493.863(e) Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- Failure to achieve an overall testing event score of satisfactory for two consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on a proficiency testing (PT) desk review of the Centers for Medicare and Medicaid (CMS) PT data report (Report 155D), the laboratory's graded results from the College of American Pathologists (CAP) and a phone interview with the laboratory manager on 10/09/2024 at 11:14 AM, the laboratory failed to achieve an overall testing event score of satisfactory performance for (2) two out of (3) three testing events for Immunohematology Compatibility testing for 2024. The findings include: 1. A PT desk review of Report 155D and graded PT results from CAP identified that the laboratory failed to achieve satisfactory scores for immunohematology compatibility testing. Analyte Year Event Score Compatibility Testing 2024 1 0% Compatibility Testing 2024 2 80% 2. A telephone interview with the laboratory manager on 10/09/2024 at 11:14 AM confirmed the above findings. -- 2 of 2 --

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, competency assessment records and an interview with the technical supervisor (TS) on 7/31/2024, the laboratory failed to follow written policies and procedures to assess testing personnel in 2023 and 2024. The findings include: 1. A review of the CMS 209 form identified 25 testing personnel and five (5) new since the previous inspection (7/29/2022). 2. A review of competency assessment records identified the laboratory failed to have documentation of annual competency for 10 testing personnel in 2023. 3. A review of competency assessment records identified the laboratory failed to have adequate documentation of six month competency assessments for three (3) testing personnel. 4. An interview with the TS on 7/31/2024 at 1:10 pm confirmed the above findings. 5. The laboratory reports performing 285,422 tests annually. 6. This is a repeat deficiency from a previous inspection completed on 3/30/2021. D5447 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(i)(g) Unless CMS Approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing, the laboratory must-- At least once a day patient specimens are assayed or examined perform the following for-- Each quantitative procedure, include two control materials of different concentrations; (g) The laboratory must document all control procedures performed. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- This STANDARD is not met as evidenced by: Based on a review of the Quality Control (QC) records, patient logs and an interview with the technical supervisor (TS) on 7/31/2024 and general supervisor (GS) on 8/1 /2024, the laboratory failed to successfully perform two levels of QC each day of use on the Curion and the Sysmex CA-660. The findings include: 1. A review of QC documents and patient log from the Curion for Helicobacter pylori testing (HpSA) for 2024 identified that the laboratory failed to perform negative and positive QC on 8/10 /2024. The laboratory performed HpSA tests on two (2) patient samples on 8/10/2024. 2. A random review of QC documents and corresponding patient results for the Sysmex CA-600 for 2022, 2023 and 2024 identified that the laboratory failed to document QC results for level 3 for prothrombin time (PT) test / INR testing on 10/4 /2023. The laboratory performed four (4) patient PT/ INR tests on 10/4/2023. 3. An interview with the TS on 7/31/2024 at 11:40 am confirmed the HpSA findings and an interview with the GS on 8/1/2024 at 8:00 am confirmed the PT/ INR finding. 4. The laboratory reports performing 10 HpSA tests and 1,184 PT/ INR tests annually. 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. This STANDARD is not met as evidenced by: Based on a review of temperature logs and an interview with the laboratory manager on 8/1/2024, the laboratory failed to perform alarm checks on the immunohematology refrigerator and freezer in 2023 and 2024. The findings include: 1. A review of laboratory temperature logs identified that the laboratory failed to perform alarm checks on the immunohematology refrigerator and freezer temperature monitoring system (SmartSense) in 2023 and 2024. 2. An interview with the laboratory manager on 8/1/2024 at 1:20 pm confirmed the above finding. 3. The laboratory reports performing 102 immunohematology tests annually. -- 2 of 2 --

Summary Statement of Deficiencies D2016 SUCCESSFUL PARTICIPATION CFR(s): 493.803(a)(b)(c) (a) Each laboratory performing nonwaived testing must successfully participate in a proficiency testing program approved by CMS, if applicable, as described in subpart I of this part for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. (b) Except as specified in paragraph (c) of this section, if a laboratory fails to participate successfully in proficiency testing for a given specialty, subspecialty, analyte or test, as defined in this section, or fails to take remedial action when an individual fails gynecologic cytology, CMS imposes sanctions, as specified in subpart R of this part. (c) If a laboratory fails to perform successfully in a CMS- approved proficiency testing program, for the initial unsuccessful performance, CMS may direct the laboratory to undertake training of its personnel or to obtain technical assistance, or both, rather than imposing alternative or principle sanctions except when one or more of the following conditions exists: (1) There is immediate jeopardy to patient health and safety. (2) The laboratory fails to provide CMS or a CMS agent with satisfactory evidence that it has taken steps to correct the problem identified by the unsuccessful proficiency testing performance. (3) The laboratory has a poor compliance history. This CONDITION is not met as evidenced by: Based on a Proficiency Testing (PT) desk review of the Centers for Medicare and Medicaid (CMS) PT data report (Report 155D), graded results from the American Proficiency Institute (API) and a telephone interview with the laboratory manger on 04 /24/2023, the laboratory failed to successfully participate and achieve an overall satisfactory score for two (2) of three (3) consecutive testing events in 2022 and 2023 for the subspecialty of routine chemistry for the analyte Total LDH. See D2096 D2096 ROUTINE CHEMISTRY CFR(s): 493.841(f) 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 -- 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 a Proficiency Testing (PT) desk review of the Centers for Medicare and Medicaid (CMS) PT data report (Report 155D), graded PT results from the American Proficiency Institute (API) and an interview with the laboratory manager on 04/24 /2023, the laboratory failed to successfully participate and achieve an overall satisfactory score for two (2) of three (3) consecutive testing events in 2022 and 2023 for the subspecialty of routine chemistry. The findings include: 1. A PT desk review of Report 155D and graded PT results from API identified that the laboratory failed to achieve satisfactory scores for the subspecialty of routine chemistry for the analyte Total LDH Analyte Year Event Score LDH 2022 3 0% LDH 2023 1 0% 2. A telephone interview with the laboratory manager on 04/24/2023 at 11:01 am confirmed the above findings. -- 2 of 2 --

Summary Statement of Deficiencies D2016 SUCCESSFUL PARTICIPATION CFR(s): 493.803(a)(b)(c) (a) Each laboratory performing nonwaived testing must successfully participate in a proficiency testing program approved by CMS, if applicable, as described in subpart I of this part for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. (b) Except as specified in paragraph (c) of this section, if a laboratory fails to participate successfully in proficiency testing for a given specialty, subspecialty, analyte or test, as defined in this section, or fails to take remedial action when an individual fails gynecologic cytology, CMS imposes sanctions, as specified in subpart R of this part. (c) If a laboratory fails to perform successfully in a CMS- approved proficiency testing program, for the initial unsuccessful performance, CMS may direct the laboratory to undertake training of its personnel or to obtain technical assistance, or both, rather than imposing alternative or principle sanctions except when one or more of the following conditions exists: (1) There is immediate jeopardy to patient health and safety. (2) The laboratory fails to provide CMS or a CMS agent with satisfactory evidence that it has taken steps to correct the problem identified by the unsuccessful proficiency testing performance. (3) The laboratory has a poor compliance history. This CONDITION is not met as evidenced by: Based on a review of the Centers for Medicare and Medicaid (CMS) proficiency testing (PT) data report (Report 155D), graded results from the American Proficiency Institute (API) and an interview with the laboratory manager, the laboratory failed to successfully participate and achieve an overall satisfactory score for two (2) of three (3) testing events in 2021 and 2022 for the specialty of hematology. See D2127, D2130 D2127 HEMATOLOGY CFR(s): 493.851(d) Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- Failure to return proficiency testing results to the proficiency testing program within the time frame specified by the program is unsatisfactory performance and results in a score of 0 for the testing event. This STANDARD is not met as evidenced by: Based on a review of the Centers for Medicare and Medicaid (CMS) Proficiency Testing (PT) data report (Report 155D), graded PT results from the American Proficiency Institute (API) and an interview with the laboratory manager on 7/28 /2022, the laboratory failed to return PT results within the specified time frame for the analyte prothrombin time resulting in a score of zero. The findings include: 1. A review of Report 155D and graded PT results from API identified that the laboratory failed to return PT results within the specified time frame for the specialty of hematology for the analyte prothrombin time resulting in a score of zero for 2022 event one. 2. An interview with the laboratory manager on 7/28/2022 at 3:00 pm confirmed that the laboratory failed to return prothrombin time PT results within the required timeframe. 3. The laboratory reports performing 946 prothrombin time tests annually. D2130 HEMATOLOGY CFR(s): 493.851(f) Failure to achieve satisfactory performance for the same analyte in two consecutive events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on a review of the Centers for Medicare and Medicaid (CMS) Proficiency Testing (PT) data report (Report 155D), graded PT results from the American Proficiency Institute (API) and an interview with the laboratory manager on 7/28 /2022, the laboratory failed to achieve satisfactory performance for two (2) consecutive PT events for the analyte prothrombin time. The findings include: 1. A review of Report 155D and graded PT results from API identified that the laboratory failed to achieve satisfactory performance for events three (3) in 2021 and one (1) in 2022 for the specialty of hematology for the analyte prothrombin time. Analyte Year Event Score Prothrombin time 2021 3 60% Prothrombin time 2022 1 0% 2. An interview with the laboratory manager on 7/28/2022 at 3:00 pm confirmed the above findings. 3. The laboratory reports performing 946 prothrombin time tests annually. D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document maintenance as defined by the manufacturer and with at least the frequency specified by the manufacturer. This STANDARD is not met as evidenced by: Based on a review of the Cepheid GeneXpert maintenance logs and an interview with the laboratory manager on 7/28/2022, the laboratory failed to perform monthly maintenance as required by the manufacturer. The findings include: 1. A review of Cepheid GeneXpert maintenance logs identified that the laboratory failed to perform -- 2 of 3 -- disinfection of the cartridge bay interior and the plunger rod monthly in June 2021, July 2021, October 2021, November 2021, May 2022 and June 2022 as required by the manufacturer. 2. An interview with the laboratory manager on 7/28/2022 at 3:05 pm confirmed that monthly disinfection of the Cepheid GeneXpert was not performed for six (6) of 15 months since the last inspection. 3. The laboratory performs SARS Covid-19, Influenza A/B, respiratory syncytial virus, group A Streptococcus, Clostridium difficile, Methicillin-resistant Staphylococcus aureus, Chlamydia trachomatis and Neisseria gonorrhoeae testing on the Cepheid GeneXpert. 4. The laboratory reports performing 2096 tests annually on the Cepheid. -- 3 of 3 --

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 training documentation, competency assessments, the Centers for Medicare and Medicaid Services (CMS) 209 personnel form and an interview on 3 /29/2021 with the laboratory manager, the laboratory failed to establish and follow written policies and procedures to assess testing personnel in accordance with 42 C.F. R. 493.1451(b)(7)(8). The findings include: 1. A review of training and competency records identified that the laboratory failed to have documentation of initial training for the Nova Biomedical blood gas instrument for sixteen (16) of twenty-six (26) testing personnel listed on the CMS 209. 2. A review of training and competency records identified that the laboratory failed to have annual competency assessments for 2020 for one (1) of twenty-six (26) testing personnel listed on the CMS 209. 3. An interview with the laboratory manager on 3/29/2021 at 4:07 pm confirmed the above findings. 4. This is a repeat deficiency from the previous survey performed on 8/13 /2018. D5221 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(d) All proficiency testing evaluation and verification activities must be documented. This STANDARD is not met as evidenced by: Based on a record review of proficiency testing (PT) from College of American 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 -- Pathologists (CAP) and American Association of Bioanalysts (AAB) and an interview with the laboratory manger on 3/30/2021, the laboratory failed to review PT and document

Summary Statement of Deficiencies D2016 SUCCESSFUL PARTICIPATION CFR(s): 493.803(a)(b)(c) (a) Each laboratory performing nonwaived testing must successfully participate in a proficiency testing program approved by CMS, if applicable, as described in subpart I of this part for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. (b) Except as specified in paragraph (c) of this section, if a laboratory fails to participate successfully in proficiency testing for a given specialty, subspecialty, analyte or test, as defined in this section, or fails to take remedial action when an individual fails gynecologic cytology, CMS imposes sanctions, as specified in subpart R of this part. (c) If a laboratory fails to perform successfully in a CMS- approved proficiency testing program, for the initial unsuccessful performance, CMS may direct the laboratory to undertake training of its personnel or to obtain technical assistance, or both, rather than imposing alternative or principle sanctions except when one or more of the following conditions exists: (1) There is immediate jeopardy to patient health and safety. (2) The laboratory fails to provide CMS or a CMS agent with satisfactory evidence that it has taken steps to correct the problem identified by the unsuccessful proficiency testing performance. (3) The laboratory has a poor compliance history. This CONDITION is not met as evidenced by: Based on a Proficiency Testing (PT) desk review of the Centers for Medicare and Medicaid (CMS) PT data report (Report 155D) and graded results from the American Proficiency Institute (API), the laboratory failed to successfully participate in PT for the specialty of routine chemistry and hematology for two (2) of three (3) consecutive testing events. The findings include: 1. A PT desk review revealed the laboratory had unsatisfactory scores for the 2nd event of 2020 and the 3rd event of 2020 for the specialty of routine chemistry and hematology from API. See D2097, D2131. D2097 ROUTINE CHEMISTRY 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 -- CFR(s): 493.841(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 a Proficiency Testing (PT) desk review of the Centers for Medicare and Medicaid (CMS) PT data report (Report 155D) and graded results from the American Proficiency Institute (API), the laboratory failed to achieve an overall testing event score of satisfactory performance for two (2) consecutive testing events for the specialty of routine chemistry for the analytes: pH blood gas, P02 blood gas, chloride, CK total and CK isoenzyme, creatinine, glucose, potassium and sodium. The findings include: 1. A PT desk review of report 155D and graded results from API revealed the laboratory failed to achieve satisfactory results for the specialty of routine chemistry from API for the analytes: pH blood gas, P02 blood gas, chloride, CK total and CK isoenzyme, creatinine, glucose, potassium and sodium. Analyte Year Event Score pH blood gas 2020 2 0% pC02 blood gas 2020 2 0% p02 blood gas 2020 2 0% chloride 2020 2 0% CK,total 2020 2 0% CK,iso 2020 2 0% creatinine 2020 2 0% glucose 2020 2 0% potassium 2020 2 0% sodium 2020 2 0% pH blood gas 2020 3 0% pC02 blood gas 2020 3 0% p02 blood gas 2020 3 0% chloride 2020 3 0% CK,total 2020 3 0% CK, iso 2020 3 0% creatine 2020 3 0% glucose 2020 3 0% potassium 2020 3 0% sodium 2020 3 0% 2. The laboratory reports performing 87 pH blood gas tests, 87 P02 blood gas tests, 9,602 chloride tests, 774 CK total tests, 567 CK isoenzyme tests, 9,642 creatinine tests, 9,681 glucose tests, 9,629 potassium tests and 9,617 sodium tests annually. D2131 HEMATOLOGY CFR(s): 493.851(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 a Proficiency Testing (PT) desk review of the Centers for Medicare and Medicaid (CMS) PT data report (Report 155D) and graded results from the American Proficiency Institute (API), the laboratory failed to achieve an overall testing event score of satisfactory performance for two (2) consecutive testing events for the specialty of hematology for the analytes: Hematocrit and Hemoglobin. The findings include: 1. A PT desk review of report 155D and graded results from API revealed the laboratory failed to achieve satisfactory results for the specialty of hematology from API for the analytes: Hematocrit and Hemoglobin. Analyte Year Event Score Hematocrit 2020 2 0% Hemoglobin 2020 2 0% Hematocrit 2020 3 0% Hemoglobin 2020 3 0% 2. The laboratory reports performing 7,877 Hematocrit tests and 7,810 Hemoglobin tests annually. D6089 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(4)(i) The laboratory director must ensure the proficiency testing samples are tested as -- 2 of 3 -- required under subpart H of this part. This STANDARD is not met as evidenced by: Based on a Proficiency Testing (PT) desk review of the Centers for Medicare and Medicaid (CMS) PT data report (Report 155D) and graded results from the American Proficiency Institute (API), laboratory director failed to ensure the proficiency testing samples were tested as required under subpart H of this part. The findings include: 1. The laboratory failed to achieve an overall testing event score of satisfactory performance for two (2) consecutive testing events for the specialty of routine chemistry for the analytes: pH blood gas, P02 blood gas, chloride, CK total and CK isoenzyme, creatinine, glucose, potassium and sodium and for the specialty of hematology for the analytes: Hematocrit and Hemoglobin, resulting in unsuccessful PT performance. See D2016, D2097 D2131 2. The laboratory reports performing 87 pH blood gas tests, 87 P02 blood gas tests, 9,602 chloride tests, 774 CK total tests, 567 CK isoenzyme tests, 9,642 creatinine tests, 9,681 glucose tests, 9,629 potassium tests, 9,617 sodium tests, 7,877 Hematocrit tests and 7,810 Hemoglobin tests annually. -- 3 of 3 --

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 record review of personnel documents and an interview with the laboratory supervisor, the laboratory failed to follow their policy to assess to perform competency on the testing personnel during 2017. Findings: 1. A review of personnel competency assessment documents and the laboratory policy, revealed the laboratory supervisor or technical supervisor failed to perform and document competency assessments for 9 out of 9 personnel listed on the CMS-209 Personnel Report form. 2. An interview on August 13, 2018 at 8:45 AM, with the laboratory supervisor, confirmed the laboratory failed to perform and document competency assessments for the testing personnel and consultants for the laboratory. D5221 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(d) All proficiency testing evaluation and verification activities must be documented. This STANDARD is not met as evidenced by: Based on record reviews and an interview with the laboratory supervisor, the laboratory failed to document the evaluations and