Roosevelt Medical Center

Summary Statement of Deficiencies D0000 A proficiency testing desk review was completed on August 11, 2025. During the desk review, it was determined that the laboratory was not in compliance with all conditions required by the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 Code of Federal Regulations, Part 493 (42 C.F.R. 493). The following condition-level deficiency was cited: 493.803 Condition: Successful participation. 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 an off-site review of the CMS-155 reports of proficiency testing performance, American Proficiency Institute (API) proficiency testing (PT) scores, corresponding laboratory records, and email communication with the technical 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 -- supervisor (TS) #1, the laboratory failed to achieve satisfactory performance for toxicology for two consecutive testing events. This resulted in unsuccessful proficiency testing performance in 2025. See D2118 D2118 TOXICOLOGY CFR(s): 493.845(f) (f) 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 review of American Proficiency Institute (API) proficiency testing (PT) scores, laboratory records, and email communication with the technical supervisor (TS) #1, the laboratory failed to achieve a score of at least 80% for two consecutive proficiency testing events for alcohol in 2025. Findings: 1. A review of API's Chemistry Toxicology PT scores and laboratory records for alcohol on August 11, 2025, revealed that the laboratory failed to achieve a satisfactory performance score of 80% or greater for the following PT events: 2025, Event 1: scored 60% 2025, Event 2: scored 0% 2. An email from TS #1 on August 1, 2025, at 7:48 PM confirmed the two consecutive failed 2025 PT events for the analyte alcohol. The failures were due to a random error in Event 1 and a failure to submit results for Event 2. -- 2 of 2 --

Summary Statement of Deficiencies D5473 CONTROL PROCEDURES CFR(s): 493.1256(e)(2)(g) (e) For reagent, media, and supply checks, the laboratory must do the following: (e) (2) Each day of use (unless otherwise specified in this subpart), test staining materials for intended reactivity to ensure predictable staining characteristics. Control materials for both positive and negative reactivity must be included, as appropriate. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: . Based on review of laboratory records and interview with the Technical Supervisor (TS)#1, the laboratory failed to document the intended staining characteristics for each day microscopic urinalysis slides were stained with KOVA Stain and manual differential slides were stained with Wright-Giemsa Stain Quicklink I. Findings include: 1. Review of laboratory records revealed the laboratory failed to document the staining quality of microscopic urinalysis slides or manual differential slides each day of testing. 2. Interview on May 13, 2021 at 9:30 AM with TS #1, confirmed the laboratory failed to document staining quality for either microscopic urinalysis slides stained with KOVA Stain or manual differential slides stained with Wright-Giemsa Stain Quicklink I. 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. 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 record review of Blood Banking and interview with Technical Supervisor (TS)#1, the laboratory failed to document the visual inspection and record the temperature of blood and blood products upon receipt of new shipments and release of blood or blood products to be transfused for years 2019 and 2020. Findings: 1. Review of Blood Banking records lacked documentation of visual inspection and temperature checks upon receipt and release of blood and blood products for years 2019 and 2020. 2. Review of American Red Cross Hospital Partner Resource Guide revealed (page 17), "If products are received out of shipping temperature range or are packed incorrectly, notify Red Cross Customer Service. These products will be managed based on the non-conformance." 3. Interview with (TS)#1 on May 13, 2021 at 11:00 AM, confirmed the laboratory failed to document visual inspection and record the temperature of blood and blood products upon receipt of new shipment and release of blood and blood products to be transfused for years 2019 and 2020. 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 review of the blood bank procedure, documentation of 2019, 2020 blood bank refrigerator and freezer alarm checks, and interview with the Technical Supervisor (TS) #1, the laboratory failed to perform and document regular alarm inspection checks for the blood bank refrigerator and freezer. Findings: 1. Review of the Blood Banking procedure (page 1) revealed, "We will check the alarm on the blood bank refrigerator and freezer three times per year." 2. Review of the 2019, 2020 documentation for alarm checks revealed the laboratory performed alarm checks on July 2, 2019; December 5, 2019; no documents were available for year 2020. 3. Interview with the TS #1 on May 13, 2021 at 11:15 AM confirmed the laboratory failed to regularly perform and document the alarm checks 3 times a year to monitor proper blood and blood product storage temperatures. -- 2 of 2 --

Summary Statement of Deficiencies D0000 Based on an on-site recertification survey conducted on 8/8/18, a deficiency was cited for Roosevelt Medical Center in Culbertson, MT. 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 observation, record review, and interview, the laboratory failed to follow manufacturer instructions for establishing the mean of the prothrombin time (PT) normal range with each new lot number of RecombiPlasTin 2G reagent for two of two lot numbers used between 7/21/16 to 8/8/18. The findings include: 1. On 8/8/18 at 7: 30 a.m., an Instrumentation Laboratory ACL Elite coagulation analyzer was observed in the laboratory. 2. On 8/8/18 at 7:30 a.m., staff member A stated PTs were performed on the ACL Elite analyzer. 3. On 8/8/18 at 11:30 a.m., a mean of the PT normal range of 11.5 seconds was observed on the ACL Elite analyzer. Data from the calculation of the 11.5 seconds mean was not located. 4. On 8/8/18 at 11:30 a.m., the current bottle of RecombiPlasTin 2G reagent in use had an observed lot number of N1166512. 5. On 8/8/18 at 11:30 a.m., staff member A stated the mean was last established in 2013. 6. A review on 8/8/18 at 12:00 p.m. of the HemosIL RecombiPlasTin 2G manufacturer instructions included instructions to "establish the mean of the PT normal range with each new lot" of RecombiPlasTin 2G. 7. A review on 8/8/18 at 12:00 p.m. of the HemosIL RecombiPlasTin 2G manufacturer instructions included a handwritten note that the current lot in use (N1166512) was started in use on 4/17/17. 8. A review on 8/8/18 at 12:00 p.m. of the ACL Elite Operator's Manual included a warning that the "mean normal range number needs to 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 -- be verified on each lot change of PT reagent as per your laboratory regulating agency." 9. A review on 8/8/18 at 12:00 p.m. of the laboratory supply card for RecombiPlasTin 2G included new lot numbers started on 1/6/16 and 3/17/17. 10. A review on 8/8/18 at 12:15 p.m. of the ACL Elite Operator's Manual included a section on the International Normalized Ratio (INR) calculation noting "that each lot number of reagent will have a unique ISI (International Sensitivity Index) value and mean of normal reference interval, which must be used as indicated." It also states "if the reagent lot number changes, then the new ISI value from the package insert and the new mean of normal range for that lot number of PT reagent must be entered." -- 2 of 2 --