Summary:
Summary Statement of Deficiencies D0000 Based on an on-site recertification survey conducted on 6/26/18, deficiencies were cited for Cardiopulmonary Care Services Central Montana Medical Center in Lewistown, MT. 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 observation, record review, and interview, the laboratory failed to monitor and document the room temperature from 8/4/16 to 6/26/18. The findings include: 1. A review on 6/26/18 at 3:00 p.m. of laboratory binders lacked documentation of the room temperature. 2. On 6/26/18 at 3:55 p.m., staff member A stated the room temperature was not documented. 3. On 6/26/18 at 4:00 p.m., a room temperature thermometer was not seen in the laboratory. 4. A review on 6/26/18 at 4:00 p.m. of the Operator's Manual included requirements for room temperature to be between 10 and 30 degrees Celsius. D6054 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) The technical consultant is responsible for evaluating and documenting the performance of individuals responsible for moderate complexity testing at least 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 -- annually, after the first year. This STANDARD is not met as evidenced by: Based on record review and interview, the laboratory technical consultant failed to evaluate and document competency evaluations for 4 of 4 testing personnel in 2017. The findings include: 1. A review on 6/26/18 at 2:00 p.m. of the competency evaluations lacked evaluations for 2017 for testing personnel A, B, C, and D. 2. On 6 /26/18 at 2:00 p.m., staff member A stated the evaluations were performed every other year. -- 2 of 2 --