Summary:
Summary Statement of Deficiencies D0000 A complaint investigation of the Urgent Care of Southington LLC Laboratory was conducted pursuant to 42CFR Part 493 of the Clinical Laboratory Improvement Amendments (CLIA) of 1988. 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: Based on record review and staff interview, the laboratory failed to follow the manufacturer's package insert for reagent storage and handling and quality control (QC). Findings include: 1. Record review on 9/1/2020 of the laboratory's quality control records revealed: a. Siemens Multistix 10SG Lot# 912045 exp. 6/30/2021. No QC records for this lot number. b. Siemens Multistix 10SG Lot#003014 exp. 8/31 /2021. Does have QC but control lot numbers are not recorded. 2. Record review on 9 /1/2020 of the Siemens Multistix 10SG package insert revealed: "CLIA Waived Laboratories: Test positive and negative quality controls with new lots new shipments of reagents and when you open a new bottle of reagent strips. Test reagents monthly that are stored for more than 30 days." 3. Surveyor observation on 9/1/2020 at 10:30 AM of the contents of the laboratory refrigerator revealed: a. Control - Consult DX Premium Liquid Urine Control level 1 (5) mL exp. 1/2019. Store at 2-8 degrees Celsius. Lot #K302278 b. Control - Consult DX Premium Liquid Urine Control level 2 (5) mL exp. 2/2019. Store at 2-8 degrees Celsius. 4. Record review on 9/1/2020 of the laboratory's 2019 and 2020 'Vaccine Refrigerator/Freezer Temperature' logs revealed: a. The refrigerator temperature range listed on the form is 2 to 8 degrees Celsius. b. The bottom of the form states, "