Summary:
Summary Statement of Deficiencies 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: A review of manufacture's package insert for Bio- Rad Liquicheck Cardiac Markers Plus Control LT and Multiqual 1,2,3, revealed the laboratory failed to follow manufacture's instructions for storage. . Findings were as follows a. Based upon Bio- Rad Cardiac and Multiqual Quality Control package insert states " Do not store this product in a Frost Free freezer'.At the time of the survey 3 packages were stored in a standard refrigerator freezer (frost free freezer) This was confirmed in interview with Technical Consultant the CMS form 209 #1 on 10/08/18 at 10:30 hrs 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: 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 -- A review of Temperature logs and interview with staff revealed the laboratory failed to establish a temperature log for laboratory storage room and drawing room to monitor temperature for vacationer tubes. Findings were as follows: a. Based upon review of manufacture's requirements the laboratory failed to establish a temperature log and range for the vacationer tubes 5-25 degrees C . b. At the time of the survey 10 /08/2018 the laboratory failed to produce