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: Through observation, review of the instrument manufacturer's operator manual, lack of documentation and interview it was determined that the laboratory failed to monitor humidity in one of one rooms in which an instrument with an operational humidity requirement is used to perform arterial blood gas analysis. Findings follow: 1. During a tour of the laboratory on 6/19/18 at approximately 12:30 PM, an ABL-800 FLEX arterial blood gas analyzer was observed. 2. Review of the instrument manufacturer's operator manual for the ABL-800 FLEX arterial blood gas analyzer revealed an operational humidity range requirement of 20% to 80%. 3. Upon request, the laboratory could not produce record of humidity level in the room in which the ABL- 800 FLEX blood gas analyzer is used. 4. In an interview on 6/19/18 at approximately 3:15 PM, the laboratory director, identified as number one on the CMS 209 form, confirmed that the ABL-800 FLEX analyzer is used to perform arterial blood gas analysis and the laboratory kept no record of the humidity level in the room in which the analyzer is used for the performance of arterial blood gas analysis. 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 --