Urine Pregnancy Screening MCL Procedure for Waived Applications

---

_{Sure Vue® Urine hCG by Fisher Healthcare}

Specimen Collection:

The first morning specimen is preferred for pregnancy screening since it is the most concentrated sample of the day. Random samples are acceptable but are not the optimum. Have patient collect a clean catch urine specimen by placing a clean, dry cup into stream after urinating for a couple of seconds. It doesn't take too much-- about one-fourth of a cup.

Testing:

If testing cannot be done within an hour after voiding, refrigerate the specimen immediately. Testing may be done on a urine sample that has been refrigerated for up to 72 hrs. Bring sample to room temperature prior to testing. Remove the test device from the protective pouch.

• Hold a new disposable dropper vertically and dispense 3 FULL DROPS of urine into the round sample well.
• Read result at 3 MINUTES.
• Positive Results: 2 colored lines appear, 1 colored line appears at the Specimen Zone (T) and another line appears at the Control Zone (C).
• Negative Results: Only 1 line appears at the Control Zone (C).
• Invalid Results: If no line appears at the Control Zone (C) even if a colored line appears at the Specimen Zone (T).

Positive result	Negative result	Invalid test #1	Invalid test #2

Quality Control:

• Maintain the proper storage conditions by keeping the testing device at room temperature and sealed in the foil pouch until just before testing.
• Do not use units that are expired or are unstable due to incorrect storage conditions.
• Follow the procedural instructions exactly.
• The internal positive control must be confirmed with EACH patient before the result is accepted. A line appearing at the Control Zone (C) confirms that test was performed correctly and that the testing device worked properly.
• The internal negative control is confirmed by the absence of interfering background in the result reading area. Confirm with EACH patient before the result is accepted. The presence of a background that interferes with the ability to read test results indicates the test was performed incorrectly or that the reagents have deteriorated.
• Repeat test, if results are invalid or inconsistent with patient's clinical findings. If results are invalid or inconsistent for the second time, submit fresh specimen for laboratory confirmation.
• Repeated failures must be reported with a nursing service problem report.
• With EACH patient, confirm and document (on QC sheet provided) that both internal positive and negative controls work. Document result in EPIC.
• The laboratory assesses the quality of the test on an ongoing basis. External quality control at the unit level is not necessary for this test.