Urine Pregnancy Screening for Research Staff

1. Urine Pregnancy Screening for Research Staff

2. These instructions refer to the QuickVue One-Step hCG Urine test kit Before testing a sample: • Check product expiration, if expired discard kit. It is considered Best Practice to: • Date and initial kit when opening.

3. Who can perform the test? • Following demonstration of clinical competency, research staff may perform the QuickVue One-Step hCG Urine Test. • Competency must include the performance of a known negative and positive sample. • Competency must be documented annually for employees.

4. Quality Control: • According to the QuickVue manufacturer, external controls should be tested with each new lot or shipment of test materials. • If the study team purchases the kits from DOCR, DOCR will QC all kits for the study teams. • If the study team purchases their own kits, they will need to QC the lot themselves according to the QuickVue manufacturer instructions. • The QC results must be adequately documented. Study teams may use the QuickVue One-Step hCG QC and Results log sheet, or a similar template of their choosing.

5. Procedure: • NOTE: Do not use if foil package appears to have been opened prior to testing. • Draw up urine into the disposable dropper and dispense 3 drops into the large round Sample well. • Read result at 3 minutes. Note: Some positive results may appear sooner. It is considered Best Practice to: • Label the Test Device with patient History number or Subjects Study ID Number.

6. Interpretation of Results: Negative Result: • Control: • A blue line appears in the square next to the letter “C” for “Control”. • Document the control reaction by recording “yes”. • Patient: • There is no change in the square next to the letter “T” for “Test”. The blue line is the only line present. • Document the reaction by using either “NEG” or as a (–), minus sign. • Record in the patient result column as “NEG”.

7. Interpretation of Results: Positive Result: • Control: • A blue line appears in the square next to the letter “C” for “Control”. • Document the control reaction by recording “yes”. • Patient: • A pink line appears below the blue linein the square next to the letter “T” for “Test”. Document the reaction by using “POS” or as a (+), plus sign. • Record in patient result column as “POS”. NOTE: ANY shade of a pink line in the Result Window should be interpreted as a positive result.

8. Interpretation of Results: Invalid Result: • If a blue line DOES NOT appear in the square next to the letter “C” for “Control”. • Document the control reaction by using a “Invalid”. The test should be repeated using a new QuickVueOne-Step hCG Test.

9. Reporting Results • Most errors occur when recording the results incorrectly! • Fill in date, time, patient’s name and history number. • Record the reactions of both the control and patient test window on the QC Log Sheet. • Write “POS” or “NEG” as the interpretation of the patient’s test result.

10. Reporting Results Templates Results may be reported on a template of the study team’s choosing. Here are two possible examples:

11. Completion of Training: • Trainer must observe your performance of commercial controls with a known positive and negative hCG test before you can perform patient screening.

12. Standard Safe Work Practices • No food, drink allowed in the screening area • Area must have place for hand-washing • Area must have Biohazard disposal • Disposal is governed by the Medical Waste Management policy on the OESO website: http://www.safety.duke.edu/safetymanuals/university/VII_3MedWaste.pdf • Work area must be maintained in a clean and sanitary condition • Procedures involving body fluids are to be performed in a manner to minimize splashing, spraying, spattering, and droplet generation

13. Approved Trainers • Ana Garcia-Turner, RPM Ophthalmology • Barbara Kurth, RPM Radiology • Bonnie Thiele, RPM, OB/GYN • Catee Mullen, RPM Heart Center • Deborah Hannah, RPM Dermatology • Eang King, RPM CFM • Holly Tiemann, DOCR • Sharon Minda, RPM Psychiatry • Terry Ainsworth, DOCR