Point of Care testingNursing and Lab partnering to

performClearview hCG Combo II

Point of Care Testing (POCT) Recertification Module 2009

• Welcome to the 2009 POCT hCG recertification module. In order to become recertified, you must complete the following steps:

POCT hCGRecertification 2009

Step 1: Review the following•Presentation•Policy & Procedure•Documentation requirements

Step 2: Read and take •Course on Kaleida Campus•Quiz on Kaleida Campus

Step 3:Make appointment to demonstrate test performance

hCG levels during pregnancy

Human chorionic gonadotropin (hCG)• is a glycoprotein hormone produced by the developing placenta shortly after fertilization. •In normal pregnancy, hCG can be detected in both urine and serum as early as 7 to 10 days after conception.1-4 •hCG levels continue to rise very rapidly, frequently exceeding 100 mIU/mL by the first missed menstrual period, and peaking in the 100,000-200,000 mIU/mL range about 10-12 weeks into pregnancy.2-4 •The appearance of hCG in both the urine and serum soon after conception, and its subsequent rapid rise in concentration during early gestational growth, make it an excellent marker for the early detection of pregnancy.

The Kit: Urine hCG testing kit Clearview hCG Combo II

• Has increased sensitivity, is easy-to-read, and easy-to-use

• Detects 20 mIU/mL hCG in Urine • Can be stored at room temperature• CLIA Waived for Urine Only

Intended Use of POCT hCG testing

• Is performed at locations where it is important to know the pregnancy status of a patient.

• Is used to determine if a patient can safely undergo a medical procedure

• It is critically important that the individual performing the test properly:– identify the patient, – properly identify and label the patient sample and– accurately perform and time the test.

• This kit is approved by Kaleida Health Labs for POCT hCG on urine ONLY.

Prior to Patient Testing

1. Verify your supplies (Clearview hCG COMBO II kit) – Each kit contains 40 test devices.

2. Verify the external controls – (MAS UA controls) have been run and properly documented for

the kit in use, or within 30 days if you are using the same kit for more than 30 days.

3. Check the expiration date on the test device. – Do not use expired test devices

4. Test devices should remain in the sealed pouch until used for patient testing or running controls.

5. Open the test device and label the individual device with the patient’s name or alternate unique identifier.

6. Check that sample has been properly labeled7. Use a timer to time the test.

– Do not interpret results before 3 minutes or after 5 minutes. – Incorrect timing may lead to false negative, false positive or

invalid results.

 

Documentation

1. All result information should be appropriately logged on the log sheet unique to each test kit, including

• Testing Location• Kit Lot number• Kit Expiration date

2. External controls run once per kit or every 30 days. If you are using the same kit more than 30 days, the external controls must be rechecked and documented every 30 days.

– Indicate lot number and expiration date of the positive and negative controls.

– Document results under “external controls” column.

3. Internal controls: refers to the expected results for each test device indicating a valid test.

– If you observe red lines, document “R” or “Red” in the “internal control” columns indicating the expected results for the internal control were the observed.

– If test background remains clear, “CL” or “clear” should be documented to indicate the expected testing condition of clear has been observed.

Documentation continued

• Failure to obtain the expected results: – Indicates the test results are invalid and cannot be

reported. – Invalid results should be repeated. – If invalid a second time, send sample to Lab for STAT

hCG

• Only the approved log sheets should be used. • When the test kit has been finished, the completed

log sheets should be sent to the Lab• Patient results should be documented in the

chart using the approved test result form (form KH 00659)

Performing HCG testing

Urine hCG test procedure

Clearview HCG Combo II Test Procedure

                                                                                     

Add 3 drops of urine to the Sample Well.** Note urines exhibiting visible precipitates should be allowed to settle to obtain a clear specimen for testing, filtered, or centrifuged.

Interpreting the Test results

Read result in 3 minutes for urine

•POSITIVE: Two distinct red lines appear. One should be in the control region <C> and the other in the test region <T>•NEGATIVE: One red line appears in the control region <C>. No red or pink line appears in the test region <T>•INVALID: Control line fails to appear. Causes can be insufficient specimen volume or incorrect procedural technique. Review procedure and repeat with a new test device. If a second invalid is obtained, send sample to Lab for testing. Notify your Nursing Supervisor and discontinue use of the kit and return it to the Laboratory, and notify Laboratory of the problem.•Upon completion of the testing the test device should be discarded appropriately.

hCG Testing Point of Care at Kaleida Health

All staff designated to perform the testing must be– Initially trained by an approved and

designated trainer.– Re-assessed at 6 months– Re-certified annually by completing the re-

certification process.

hCG Testing Point of Care at Kaleida Health

All testing will be performed:– With approved kits according to Kaleida

Health Lab Policy LB-POC-06– On patients as ordered by the physician

or other licensed healthcare professionals authorized to order testing.

hCG Testing Point of Care at Kaleida Health

Results will be completely documented on the appropriate log sheets.

Point of Care hCG Testing is Important Because when done properly it

determines the Pregnancy Status of a patient

• Knowing the pregnancy status of a patient is important information for the caregivers to have accurately and quickly

• Contributes to improving patient safety as some procedures are not advisable if the patient is pregnant

• It helps us provide the most efficient and effective care for our patients

Correct Technique and Specimen Integrity are Critical factors for Accurate Results

• Just any result is not a good result. Proper procedure and technique must be followed to obtain a good result.

• The best result comes from using– the right kit– the correct patient sample, – the right procedure, and – reporting the right result.

• Unlabeled samples, improperly performed testing, improper timing of the procedure are some of the contributing factors for a potential “bad” result.

Do the right thing

Always take the time to do it right. It really does matter.