Bozeman Health Belgrade Clinic

Summary Statement of Deficiencies D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) The laboratory must define criteria for those conditions that are essential for proper storage of reagents and specimens, accurate and reliable test system operation, and test result reporting. The criteria must be consistent with the manufacturer's instructions, if provided. These conditions must be monitored and documented and, if applicable, include the following: (1) Water quality. (2) Temperature. (3) Humidity. (4) Protection of equipment and instruments from fluctuations and interruptions in electrical current that adversely affect patient test results and test reports. This STANDARD is not met as evidenced by: Based on review of laboratory records and interview with general supervisor (GS) #1, the laboratory failed to record temperature for the dry heat block (Fisher Scientific Isotemp Dry Bath). Findings: 1. No temperature log for the dry heat block was available for review. 2. Interview with GS #1 on 4/5/2021 at 11:00 AM confirmed the laboratory failed to document temperatures for the dry heat block. 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 6/11/18, a deficiency was cited for Bozeman Health Belgrade Clinic in Belgrade, MT. D3031 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3) Analytic systems records. Retain quality control and patient test records (including instrument printouts, if applicable) and records documenting all analytic systems activities specified in 493.1252 through 493.1289 for at least 2 years. This STANDARD is not met as evidenced by: Based on observation, record review, and interview, the laboratory failed to retain quality control values for the hematology analyzer from 3/25/17 through 1/7/18. The findings include: 1. On 6/11/18 at 9:30 a.m. a Beckman Coulter DxH 600 hematology analyzer was observed in the laboratory. 2. A review on 6/11/18 at 11:45 a.m. of the quality control results between 3/25/17 and 1/7/18 were not retained on paper, saved electronically, retained on the analyzer, or on the quality control website. 3. On 6/11 /18 at 11:45 a.m., staff member A stated the results were not kept. 4. A review on 6/11 /18 at 12:50 p.m. of the November 2017 UniCel DxH Series Cleaning Checklist included a box daily to check for process controls. The boxes were all checked. 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 --