Summary:
Summary Statement of Deficiencies D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) Reagents, solutions, culture media, control materials, calibration materials, and other supplies must not be used when they have exceeded their expiration date, have deteriorated, or are of substandard quality. This STANDARD is not met as evidenced by: Based on review of manufacturer's inserts, quality control (QC) logs, and interview with technical consultants #1 and #2, the laboratory used QC material past the expiration date. Findings: 1. Review of the R & D systems Hematology Control showed "Opened vials are stable for 30 days provided they are handled properly." 2. Review of the QC logs for January and March 2019 showed the laboratory used level I and level II for 31 days of testing. 3. Interview with the technical consultants #1 and #2 on April 1, 2019 at 2:00 PM confirmed the laboratory used the QC material past the expiration date. D6042 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(4) (b) The technical consultant is responsible for-- (b)(4) Establishing a quality control program appropriate for the testing performed and establishing the parameters for acceptable levels of analytic performance and ensuring that these levels are maintained throughout the entire testing process from the initial receipt of the specimen, through sample analysis and reporting of test results; This STANDARD is not met as evidenced by: Based on review of white blood cell (WBC) quality control (QC) records for January through March 2019, policy for QC acceptability and interview with the technical 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 -- consultants #1 and #2, the technical consultants failed to ensure acceptable levels of analytic performance were maintained throughout the entire testing process. Findings: 1. Review of the QC logs for January through March 2019 for WBC counts performed on the Hemocue showed 2 results out of range for the normal control on February 1 and 5, 2019. One patient was resulted on each of the days the control was unacceptable. The technical consultants failed to document any review of unacceptable QC on the QC logs. 2. Review of the QC policy stated "Monthly review of quality control data is performed by the point-of-care technical consultant. A report of any areas with need for improvement is forwarded to the site supervisor or designee. Employees are made aware of ongoing quality issues by the site supervisor or designee, when necessary." 3. Interview with the technical consultants #1 and #2 on April 1, 2019 at 1:30 PM confirmed the technical consultants failed to ensure acceptable analytic performance. -- 2 of 2 --