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: Through a review of the Sysmex XS 1000i Operator's Manual, a review of the Humidity-Temperature Log, and interviews with laboratory staff, it was determined the laboratory failed to perform complete blood counts on the Sysmex XS 1000i following the manufacturer's instructions. Survey findings follow: A. The Sysmex XS 1000i Operator's Manual states that the acceptable operating humidity for the instrument is 30% to 85%. B. A review of the Humidity-Temperature Log for January and February 2018 revealed the humidity of the laboratory was unacceptable on 5 of 24 days of testing. There was no action documented to ensure testing was performed within the operating humidity required by the manufacturer. Humidity was outside the manufacturer's operating range of 30% to 85% on the following dates in January and February 2018: 1/4/2018 27%; 2/1/2018 28.3%; 2/2/2018 28.1%; 2/9/2018 27.7%; and 2/12/2018 23.0%. C. In an interview, at 2:48 p.m. on 9/18/2018, laboratory employee #2 (as listed on the form CMS-209) confirmed the Sysmex XS 1000i had been used for patient testing when the laboratory humidity was outside of the manufacturer's operating range. 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 --