Title:
Quality Control Procedures for Urine Pregnancy Test
Date Revised:
Approved by:
06/24/2014
Tanya Page, MD Lab Director
Test type: Consult Diagnostics hCG Dipstick [CLIA-waived]
Test Method: Qualitative
Control reagent used: Consult Urine Dipstick control (Dropper style); Level 1 and Level 2
Frequency: Both normal and abnormal levels should be tested for quality control with new
lot/shipment of test kits, when training new operators, or in the event of a questionable test result. In
addition, monthly controls are performed by the Lab Coordinator.
Precautions: All controls should be performed with the protection of gloves and a clear work space and
handled in the same manner as a potentially infectious specimen.
Procedure:
1. Print a copy of the In-house labs Quality Control log:
\\inside\Clinic\Back_Clinic\CLIA Binders\Quality Control Manual\Quality Control
Logs\Control_Log_Blank.doc
Record the lot number and expiration date for control reagents and dipsticks.
2. Take out two foil pouches containing hCG dipsticks from the most current box. Grab both “Level
1” and “Level 2” Urinalysis Control urine control solution bottles.
3. Set two clear test tubes on a blue tube stand. Label the tubes in a fashion that differentiates
Level 1 and Level 2.
a. The blue tube stands are typically used for HIV rapid tests, but can be used in this
instance as a holder.
4. Record the lot numbers and expiration dates for both the dipsticks and the control urine
solutions in the control log
5. Hold the “Level 1” control dropper vertically and place three drops in the normal tube
6. Hold the “Level 2” control dropper vertically and place three drops in the abnormal tube
7. Open the foil pouches for both dipsticks and place one dipstick in each of the tubes
8. Set a timer for three minutes and read the results of each dipstick
a. A single stripe should appear on both Level 1 and Level 2 as a result of internal quality
control measures (see image below).
b. A double stripe should appear on the abnormal control dipstick
c. If either dipstick shows no stripe after three minutes, contact a lab coordinator,
administrator, or medical assistant immediately.
JM 06/2014
\\inside\Clinic\Back_Clinic\CLIA_Binders\Quality Control Manual\Quality Control Protocols\Urine HCG
Controls.docx
9. Record the results in the control log, and initial.
a. If any deviations occur, take corrective action. Follow the steps outlined in the flowchart
included in the ‘Documentation of Procedures and Machine Maintenance Instructions’
sheet that can be found here:
\\inside\Clinic\Back_Clinic\CLIA_Binders\Quality Control Manual\Quality Control
Protocols\quality_control_locations_instructions.docx
JM 06/2014
\\inside\Clinic\Back_Clinic\CLIA_Binders\Quality Control Manual\Quality Control Protocols\Urine HCG
Controls.docx