Summary:
Summary Statement of Deficiencies D5431 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(2) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document function checks as defined by the manufacturer and with at least the frequency specified by the manufacturer. Function checks must be within the manufacturer's established limits before patient testing is conducted. This STANDARD is not met as evidenced by: Based on the surveyor's review of instrument function records and confirmed in an interview with the POL Coordinator and a laboratory testing person, the laboratory failed to follow the manufacturer's directions for performing and documenting daily instrument background checks for the Abbott Cell Dyn 1800 hematology analyzer for the 2016 and 2017 calendar years. FINDINGS: Daily background check printouts have not been retained for two years, as required. D6063 LABORATORY TESTING PERSONNEL CFR(s): 493.1421 The laboratory must have a sufficient number of individuals who meet the qualification requirements of 493.1423, to perform the functions specified in 493. 1425 for the volume and complexity of tests performed. This CONDITION is not met as evidenced by: Based on the surveyor's review of personnel records and an interview with the POL Coordinator and a laboratory testing person, the laboratory failed to ensure that one of the two laboratory's testing personnel met the educational requirements necessary to perform testing in the laboratory. FINDINGS: Documentation of education (equivalency evaluation of foreign to United States education) was not available for 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 -- review for one of the two foreign educated persons who performs laboratory testing. Refer to D6065 D6065 TESTING PERSONNEL QUALIFICATIONS CFR(s): 493.1423(b)(1)(2)(3)(4)(i) (b) Meet one of the following requirements: (b)(1) Be a doctor of medicine or doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located or have earned a doctoral, master's, or bachelor's degree in a chemical, physical, biological or clinical laboratory science, or medical technology from an accredited institution; or (b)(2) Have earned an associate degree in a chemical, physical or biological science or medical laboratory technology from an accredited institution; or (b)(3) Be a high school graduate or equivalent and have successfully completed an official military medical laboratory procedures course of at least 50 weeks duration and have held the military enlisted occupational specialty of Medical Laboratory Specialist (Laboratory Technician); or (b)(4)(i) Have earned a high school diploma or equivalent; and This STANDARD is not met as evidenced by: Based on the surveyor's review of personnel records and an interview with the POL Coordinator and a laboratory testing person, the laboratory failed to ensure that one of the two laboratory's testing persons met the educational requirements necessary to perform testing in the laboratory. FINDINGS: Documentation of education (equivalency evaluation of foreign to United States education) was not available for review for one of the foreign educated person who performs laboratory testing. -- 2 of 2 --