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 manufacturer's instructions, review of laboratory instrument records, and confirmed in interview of facility personnel, the laboratory failed to establish an acceptable room temperature range where the Medonic M-Series hematology analzyer is operated. The findings were: 1. Review of the manufacturer's instructions for the Medonic-M Series hematology analyzer (February 2016, Article No. 1504470) under "Specifications" it stated the operating temperature for the analyzer is "18-32 degrees Celsius." 2. Review of the laboratory's environmental records revealed the laboratory had established its acceptable room temperature as 15- 32 degrees Celsius. 3. The findings were confirmed in interview of the technical consultant and laboratory manager on July 9, 2019 at 21:00 hours in the office. D6018 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(iii) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory 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 -- director must-- (e)(4)(iii) Ensure that all proficiency testing reports received are reviewed by the appropriate staff to evaluate the laboratory's performance and to identify any problems that require