St Luke Community Healthcare

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 American Proficiency Institute records and an interview with the technical supervisor, the laboratory failed to achieve satisfactory performance for manual red blood cell counts (erythrocyte) and manual polymorphonuclear cell counts (leukocyte) performed with a hemocytometer for two consecutive or two out of three consecutive testing events, resulting in unsuccessful proficiency testing performance. (See D2130) D2130 HEMATOLOGY CFR(s): 493.851(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 3 -- 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 American Proficiency Institute (API) proficiency testing (PT) scores and an interview with technical supervisor (TS) # 1, the laboratory failed to achieve a score of at least 80% for two consecutive testing events for manual red blood cell (RBC) counts for cerebrospinal fluid/body fluid performed with the hemocytometer and two out of three consecutive testing events for manual polymorphonuclear cells (PMN) counts for cerebrospinal fluid (CFS)/body fluid (BF) performed with the hemocytometer. Findings: 1. A review of the API Manual RBC cell counts of CSF/BF proficiency testing scores revealed that in 2022, Event 3 scored 50% and in 2023, Event 1 scored 50%. 2. A review of the API Manual PMN cell counts of CSF/BF proficiency testing scores revealed that in 2022, Event 1 scored 0% and Event 3 scored 50%. 3. An interview with TS #1 on March 26, 2023, at 11:00 AM confirmed the laboratory's unsuccessful proficiency testing scores were due to a calculation error based on the size of hemocytometer. 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 a review of Beckman Coulter DxH 690T and DxH 520 hematology analyzer verification records and an interview with technical supervisor (TS) #1, the laboratory lacked precision studies to assess day-to-day variation over time and failed to verify the normal reference ranges were appropriate for the laboratory's patient population prior to patient testing from February 5, 2024, to March 26, 2024. Findings: 1. A review of the Beckman Coulter DxH 690T and DxH 520 Hematology Analyzers verification records revealed the laboratory failed to have more than two days of data to assess the reproducibility of day-to-day variance over time. 2. The laboratory failed to perform patient population studies to verify reference intervals (normal values) to support the reference ranges listed in the laboratory's patient results reports. 3. The laboratory lacked a procedure for verifying new assays, instruments, or methods. 4. An interview with TS #1 on March 26, 2024, at 3:00 PM confirmed the lack of reproducibility studies over time and verification of the normal reference ranges for DxH 690T and DxH 520 hematology analyzers prior to patient testing from February 5, 2024, to March 26, 2024. D5555 IMMUNOHEMATOLOGY CFR(s): 493.1271(c)(f) (c) Blood and blood products storage. Blood and Blood products must be stored under -- 2 of 3 -- 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 policies, records of blood bank alarm checks, and an interview with the technical supervisor (TS) #1, the laboratory failed to follow their policies to perform and document quarterly alarm checks for one out of one blood bank refrigerator and freezer from March 26, 2022, to March 26, 2024. Findings: 1. The laboratory failed to perform a quarterly "hi/lo alarm check" on the blood bank refrigerator and sub-zero freezer as required by their "Blood Bank Maintenance & Function Checks" procedure. 2. The laboratory lacked documentation of blood bank alarm checks for the refrigerator and freezer from March 26, 2022, to March 26, 2024. 3. An interview with TS #1 on March 26, 2023, at 2:20 PM confirmed the laboratory failed to perform and document quarterly alarm checks per their procedure from March 26, 2022, to March 26, 2024. -- 3 of 3 --

Summary Statement of Deficiencies D3021 REQUIREMENTS FOR TRANSFUSION SERVICES CFR(s): 493.1103(c)(1) Blood and blood products storage and distribution. If a facility stores or maintains blood or blood products for transfusion outside of a monitored refrigerator, the facility must ensure the storage conditions, including temperature, are appropriate to prevent deterioration of the blood or blood product. This STANDARD is not met as evidenced by: Based on review of immunohematology records, procedures, and interview with Technical Supervisor (TS) # 1, the laboratory failed to ensure the temperature was documented upon receipt of new shipments of blood products and of reissued blood products not used for transfusion from June 1, 2020 to June 28, 2022. Findings: 1. Immunohematology records lacked documentation of temperatures upon receipt of new shipments of blood products and of reissued blood products not used for transfusion from June 1, 2020 to June 28, 2022. 2. Review of laboratory procedures "Stock Inventory #8029" and "Return and Reissue of Blood for Transfusion #8033" lacked instructions for taking and recording temperatures for new shipments of blood products and unused blood products reissued. 3. The interview with TS #1 on June 28, 2022 at 2:30 PM, confirmed the laboratory failed to ensure the temperature was documented upon receipt of new shipments of blood products and reissued blood products not used for transfusion from June 1, 2020 to June 28, 2022. 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. 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 hematology and urinalysis record review, procedures and interview with the Technical Supervisor (TS) #1, the laboratory failed to include the normal reference ranges in the patient results reports for urinalysis(UA), manual cell count for body fluids (pleural and cerebral spinal) from June 1, 2020 to June 28, 2022. Findings: 1. Review of UA patient results report (#0628:U00002S), cell count for pleural fluid (#0628:HF00001S) and cell count for cerebral spinal fluid (#1120:HF00002R) lacked normal reference ranges. 2. Review of Hema 3 Stain and Routine Urinalysis procedures lacked information for normal reference ranges 3. Interview with TS #1 on June 28, 2022 at 11:30 AM , confirmed the patient results report lacked normal reference ranges for UA and cell counts for body fluids from June 1, 2020 to June 28, 2022. -- 2 of 2 --

Summary Statement of Deficiencies 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 record review and interview with laboratory staff, the laboratory failed to maintain certification of the Biosafety Cabinet (Baker, SG403) located in the Laboratory for 2019. Findings include: 1. Review of Asepsis, LLC, Laminar Flow Hood Evaluation records for annual certification, showed documentation for 2018 and 2020, but lacked documentation for the year 2019. 2. Interview on 12/8/20 at 3:08 pm with General Supervisor (GS) confirmed certification was not performed for the year 2019. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --

Summary Statement of Deficiencies D0000 Based on an off-site proficiency testing desk review conducted on 5/30/18, deficiencies were cited for St Luke Community Healthcare in Ronan, 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 compatibility testing for two of three events (2017 event 2 and 2018 event 1), resulting in unsuccessful proficiency testing performance. See D2181. D2181 COMPATIBILITY TESTING 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): 493.863(e) 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 review of proficiency testing scores and interview, the laboratory failed to achieve a score of 100 percent for compatibility testing in two of three events in 2017 and 2018, resulting in unsuccessful performance. The findings include: 1. During a review on 5/29/18 at 8:15 a.m. of the CMS-153 Unsuccessful Proficiency Testing Report included St Luke Community Healthcare with unsuccessful proficiency testing scores for compatibility testing. 2. During a review on 5/29/18 at 8:20 a.m. of the CMS-155 report, the American Proficiency Institute (API) compatibility testing score for event 2 of 2017 was 80%. 3. During a review on 5/29/18 at 8:20 a.m. of the CMS- 155 report, the API compatibility testing score for event 1 of 2018 was 80%. 4. On 5 /30/18 at 2:35 p.m., the laboratory manager stated the lab will investigate the failures. -- 2 of 2 --

Summary Statement of Deficiencies No Tags No deficiency details available. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --