Summary:
Summary Statement of Deficiencies D1001 CERTIFICATE OF WAIVER TESTS CFR(s): 493.15(e) Laboratories eligible for a certificate of waiver must-- (1) Follow manufacturers' instructions for performing the test; and (2) Meet the requirements in subpart B, Certificate of Waiver, of this part. This STANDARD is not met as evidenced by: A. Based on review of laboratory records and interview with laboratory testing personnel (TP); the laboratory failed to follow manufacturer's instructions for macroscopic urinalysis. Findings Include: 1. Review of the manufacturer's instructions for McKesson 10SG Urine Reagent Strips (10 Parameter) state under the section "Storage and Stability" the following: "Note: Once the canister has been opened, the remaining strips are stable for up to 3 months." 2. Direct observation on 7-16-2018, at 11:23am, identified McKesson 10SG Urine Reagent test strips, lot #URS7060177, which failed to indicate the date the strips were opened. 3. Interview on 7-16-2018, at 12:10pm, with TP#1 confirmed the date the reagent strips were opened was not documented and the date of opening was unknown. B. Based on review of laboratory records and interview with laboratory testing personnel (TP); the laboratory failed to follow manufacturer's instructions for blood glucose testing. Findings Include: 1. Review of the manufacturer's instructions for the OneTouch Ultra Mini glucose meter states under the section "When to test with control solution" the following: "Do a Control solution test: - once a week" 2. Review of quality control testing records found glucose control testing on the one touch ultra mini was documented one time in the past two years, 06-25-2018. 3. Interview on 7-16-2018, at 12:10pm, with TP#1 confirmed prior to 6-25-2018 glucose control testing was not performed by the laboratory and currently the laboratory is only performing control testing when a new vile of test strips is opened. 4. Direct observation on 7-16-2018, at 11:27am, identified OneTouch Ultra strips, lot #4212269, which failed to indicate the date the strips were opened. 5. Review of the product insert for the OneTouch Ultra test strips under the 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 -- section, Storage and Handling state to "Write the discard date (date opened plus 6 months) on the vial label when you first open it" 6. Interview on 7-16-2018, at 12: 10pm, with TP#1 confirmed the date the test strips were opened was not documented and the date of opening was unknown. -- 2 of 2 --