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 review of the manufacturer's instructions for the Alere iCassette Drugs Screen , revealed the laboratory failed to follow the manufacture's instruction when a positive result is obtained. The findings were as follows: a. A review of the manufacturer's instructions for the Alere iCassette Drugs Screen states " when a positive result is obtained the specimen must be confirmed" b. Based upon interview with Technical Consultant #1 (from the CMS form 209) on April 23, 2019 at 1100 hrs stated " the laboratory does not send the positive drug screen for confirmation unless the physician orders The laboratory performs from January 1, 2019 to April 23, 2019 8 patients 4 of which had positive test and were not sent off for confirmation. . 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 --