Summary:
Summary Statement of Deficiencies D1001 CERTIFICATE OF WAIVER TESTS CFR(s): 493.15(e) 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 observation, record review, and interview, the laboratory failed to follow manufacturer's instructions by using expired test kit strips (Q-Test 11 Lot number: 210715) to perform urinalysis on five of five patients (PT-1 through PT-5) on 4/14 /2025 for four of four analytes tested (Specific Gravity (SG), urine blood (blood), urine protein (pro), and urine glucose (glu). Findings include: 1. On 05/07/2025 at 12: 18 pm, six urine specimens were observed on a table in the physical exam room. The specimen cups did not display labels or patient identifiers. A bottle of Q-Test 11 (Lot number: 210715) with an expiration date of 07/14/2023 and no open date written on the bottle was observed sitting beside the urine samples. 2. A review of medical examination report forms for patients (PT-1 through PT-5) tested on 4/14/2025 indicated urinalysis had been performed using expired test kit strips. Patient (PT) Outcome Analyte(s) Pt-1 Negative Blood, Pro, Glu, 1.020 SG Pt-2 Negative Blood, Pro, Glu, 1.020 SG Pt-3 Negative Blood, Pro, 250++ Glu, 1.020 SG Pt-4 Negative Blood, Pro, Glu, 1.020 SG Pt-5 Negative Blood, Pro, Glu, 1.020 SG 3. In an interview on 05/07/2025 at 2:30pm, SP-2 (Laboratory Director) acknowledged the Q-Test 11 testing strips were expired, they do not keep track of lot numbers received, and package inserts are not retained. 4. Manufacturer's instruction for the Q-test "Reagent Strips for Urinalysis", revision 10 2014-12-16 required under "Storage and handling" "Do not use after the expiry date." 5. Annual test volume for waived urinalysis is 800. 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 --