Urine Pregnancy Screening for Research Staff
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Transcript of Urine Pregnancy Screening for Research Staff
All Rights Reserved, Duke Medicine 2007
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.
All Rights Reserved, Duke Medicine 2007
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.
All Rights Reserved, Duke Medicine 2007
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.
All Rights Reserved, Duke Medicine 2007
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.
All Rights Reserved, Duke Medicine 2007
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”.
All Rights Reserved, Duke Medicine 2007
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 line in 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.
All Rights Reserved, Duke Medicine 2007
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 QuickVue One-Step hCG Test.
All Rights Reserved, Duke Medicine 2007
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.
All Rights Reserved, Duke Medicine 2007
Reporting Results Templates
Results may be reported on a template of the study team’s choosing. Here are two possible examples:
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All Rights Reserved, Duke Medicine 2007
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.
All Rights Reserved, Duke Medicine 2007
Standard Safe Work Practices
• No food, drink allowed in the screening area• Area must have place for hand-washing• 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
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All Rights Reserved, Duke Medicine 2007
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
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