Beartooth Billings Clinic

Summary Statement of Deficiencies D5791 ANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1289(a)(c) (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 analytic systems specified in 493.1251 through 493.1283. (c) The laboratory must document all analytic systems assessment activities. This STANDARD is not met as evidenced by: Based on review of records, policy, and interview with General Supervisor (GS) #1, the laboratory failed to establish a written quality assurance (QA) policy to outline an ongoing mechanism to monitor, assess and correct problems in the laboratory from April 14, 2021 to September 21, 2022. Findings: 1. No quality assurance policy to cover the laboratory's preanalytical, analytical and post analytical systems was available for review. 2. Review of Quality Improvement Activities/Calendar revealed, "BC is fixing the Cerner TAT monitor" documented since 2018 with no resolution. 3. Review of Quality Improvement Activities/Calendar lacked assessment of the analytical system for test procedures; specimen and reagent storage condition; maintenance and function checks; establishment and verification of method performance specifications; calibration and calibration verification; control procedures; comparison of test results;

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 hematology policy manual, laboratory records and interview with the General Supervisor (GS)#1, the laboratory failed to document the intended staining characteristics for each day manual differentials slides were stained with the Hema 3 Stain Set. Findings include: 1. Review of hematology records revealed the laboratory failed to document the staining quality of manual differential slides each day of Hema 3 Stain Set use for years 2019 and 2020. 2. Review of policy # LABH002 procedure lacked how the laboratory would document staining quality control checks on manual differentials slides. 3. Interview on April 14, 2020 at 11:30 AM with GS #1, confirmed the laboratory failed to document staining quality of manual differential slides using Hema 3 Stain Set for years 2019 and 2020. 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 on-site recertification survey conducted on 3/13/18, deficiencies were cited for Beartooth Billings Clinic in Red Lodge, MT. D2010 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(2) The laboratory must test samples the same number of times that it routinely tests patient samples. This STANDARD is not met as evidenced by: Based on record review and interview, the laboratory failed to test proficiency samples the same number of times as patient samples for three of three proficiency events in 2017. The findings include: 1. A review on 3/13/18 at 8:40 a.m. of the American Proficiency Institute (API) blood bank attestation documents included multiple testing personnel signing for testing blood bank samples. 2. A review on 3/13 /18 at 3:00 p.m. of the Beartooth Billings Clinic blood bank patient log included multiple API test result entries for each event in 2017, while patients included one test result. a. 2017 event 1 included results for testing on 4/6/17, 4/10/17, and 4/12/17. b. 2017 event 2 included results for testing on 8/9/17 and 8/16/17. c. 2017 event 3 included results for testing on 12/8/17, 12/11/17, and 12/21/17. 3. On 3/13/18 at 3:30 p.m., staff member A stated each testing person performed API testing for each event to maintain competency due to low patient volume. 4. On 3/13/18 at 3:30 p.m., staff member B stated the results submitted to API were from the first person testing the samples most of the time due to degradation of the product over time. 5. A review on 3 /13/18 at 4:00 p.m. of the Beartooth Billings Clinic Handling of Proficiency Testing Samples Policy stated "samples MUST be tested in the same manner as patient samples." 6. A review on 3/13/18 at 4:00 p.m. of the API webpage for Beartooth Billings Clinic showed results were submitted to API after multiple testing personnel 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 -- had tested the samples. a. 2017 event 1 results were submitted to API on 4/13/17. b. 2017 event 2 results were submitted to API on 8/17/17. c. 2017 event 3 results were submitted to API on 12/12/17. D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: Based on observation, record review and interview, the laboratory failed to perform accuracy verification for potassium hydroxide (KOH) preps at least twice annually from 3/25/16 through 3/13/18. The findings include: 1. A review on 3/13/18 at 8:40 a. m. of the American Proficiency Institute (API) documentation lacked proficiency testing enrollment for KOH. Accuracy verification was not documented. 2. On 3/13 /18 at 8:40 a.m., staff member B stated KOH preps are performed in the laboratory and API was not enrolled for KOH. 3. On 3/13/18 at 8:55 a.m. the Remel KOH reagent vials were observed next to the microscope in the laboratory. 4. A review on 3 /13/18 at 8:50 a.m. of the test volume report for Beartooth Billings Clinic included an annual test volume of 12 KOH preps. 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 directions on the Sysmex CA-600 analyzer for one of three tests performed on that analyzer from 3/25/16 through 3/13/18. The findings include: 1. On 3/13/18 at 8:15 a.m. a Sysmex CA-600 analyzer was observed in the laboratory. 2. On 3/13/18 at 8:15 a.m., staff member B stated D-dimer, prothrombin time (PT), and partial thromboplastin time (PTT) are performed on the Sysmex CA-600. 3. A review on 3/13/18 at 8:50 a.m. of the annual test volume report for Beartooth Billings Clinic included 2046 PTs performed annually. 4. On 3/13/18 at 12:00 p.m., a normal patient mean of 10.0 seconds was observed on the analyzer for calculation of the international normalized ratio (INR). 5. A review on 3/13/18 at 12:00 p.m. of the calculated patient mean for the current lot of Innovin in use was 10.3 seconds. The calculated patient mean for the previous lots of Innovin were 10.3 seconds and 10.7 seconds. 6. On 3/13 /18 at 12:00 p.m., staff member A stated the mean was different. 7. A review on 3/13 /18 at 12:30 p.m. of the Beartooth Billings Clinic Determination of INR policy stated in the notes section the "normal PT is defined as the mean of the normal range and must be specifically determined for each lot of thromboplastin." Instructions on entering the mean normal PT into the analyzer was not included. 8. A review on 3/13 /18 at 12:30 p.m. of the Beartooth Billings Clinic Prothrombin Time Normal Range -- 2 of 3 -- policy stated "determine the mean, standard deviation (SD) and range once the data has been collected." Instructions on entering the mean normal PT into the analyzer was not included. -- 3 of 3 --