Summary:
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 the manufacturer's instrument specifications for the Beckman Coulter Immage 800, review of the laboratory's established ambient relative humidity range and interview with the laboratory personnel, the laboratory's humidity range did not meet the acceptable humidity range indicated by the manufacturer. Findings include: 1. The laboratory's current humidity range indicated on the log sheet is 2% -74%, while the manufacturer's humidity range indicated in the operations manual is 15%-85%. 2. The laboratory personnel acknowledged that the ranges were not compatible. 3. The humidity recordings indicated on the log did not fall below 15% or above 85% since the instrument was utilized for patient testing starting in September 2018. 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. 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 review of Quality Assessment (QA) documentation, quality control records and interview with the facility personnel, the laboratory failed to identify errors found in the analytic systems. Findings include: 1. The laboratory began patient testing on the Beckman Coulter Immage 800 test system in September 2018 under the sub- specialty of General Immunology. The laboratory performs a Total Serum IgG/IgA/ IgM (GAM) test on this analyzer. 2. It is the practice of the laboratory to perform 3 levels of Quality Control (QC) for the GAM test, Low, Normal and High. The QC lot information for each level is manually entered into the instrument, including control ranges and lot number. The laboratory manually documents daily QC results and QC information on an "Assay Coversheet", which is reviewed for acceptance and accuracy by several laboratory personnel. 3. The Assay Coversheet for GAM testing performed on 11/16/18 indicated the Low QC Lot# as M710251 and the Normal QC Lot# as M710252. The QC information entered in the analyzer from 11/16/18 indicated the Low QC Lot# as M805011 and the Normal QC Lot# as M805012. 4. No