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: Based on surveyor review of the Manufacturer's Package Insert (MPI), observation of the incubator, and interview with the Laboratory Director (LD), the laboratory failed to follow the manufacturer's instruction for incubating throat culture plates from 7/6 /17 to the date of survey. The finding includes: 1. The MPI for bacitracin discs stated to incubate the sample between 33-37 Celsius (C) but the incubator temperature log revealed the acceptable temperature was 34-38 (C). 2. The LD confirmed on 7/30/19 at 1:10 pm that the laboratory did not follow the MPI. 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 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