36C26219R0026-027.pdf

VISN 22 Consolidated Pathology & Laboratory Medicine Service

VA Loma Linda Healthcare System Loma Linda, CA 92357

Issue Date:

07/19/2017

Approved by:

Heather Rojas (Physician)

Version

Document Owner:

Marilyn Malto (ATC)

POC-S8554 QUALITATIVE URINE hCG USING SURE-VUE STAT™ AT A CBOC

Printed copies are for reference only; Please refer to the electronic copy for the latest version

Purpose Sure-Vue Stat ™ hCG is a rapid and visually read immunoassay screening test used for the qualitative determination of human chorionic gonadotropin (hCG) in serum or urine, and is most commonly used to determine pregnancy. This test kit is intended for in-vitro diagnostic use only.

Principal The Sure-Vue Stat ™ test utilizes a combination of monoclonal and polyclonal antibody reagents to selectively detect elevated levels of hCG in serum and urine. The assay is conducted by the addition urine specimen into the test device sample well and observing for the formation of 1 or 2 colored lines. The specimen migrates via capillary action along the membrane and reacts with the colored conjugate. A positive specimen reacts with the hCG-specific antibody colored conjugate and forms a colored line at the T (test) window. Absence of this colored line suggests a negative result. To serve as a control for the procedure, a colored line at the C (control) area should always appear regardless of the presence (positive) or absence (negative) of hCG in the sample. Sure-Vue hCG STAT detects hCG at concentration of 20mIU/ml or greater in urine.

Policies

1. Clinic must have CLIA Certificate for Waived testing

2. Clinic must enroll in a VA approved formal proficiency testing program.

3. Tests performed must be ordered by a physician or nurse practitioner.

4. Initial training and yearly competencies must be done by the trained site trainer or the Ancillary Testing Coordinator.

5. Site trainer must be trained by the Ancillary Testing Coordinator or designee.

6. Original copies of training documents must be submitted to the Ancillary Testing Coordinator in a timely manner.

7. Testing must be performed and interpreted by trained and competent personnel.

8. Results are documented on the site sharepoint.

9. Results must be communicated to the ordering provider and must be entered in the patient medical record through the Accuchek Inform II or on CPRS on the Point of Care template.

10. Access codes must not be shared with anyone.

11. Liquid Quality Control must be tested daily or prior to patient testing and once a month.

12. All Quality Control and patient logs must be reviewed and signed off by the CLIA site director at the end of each month.

13. Quality Control Records and patient records are retained for a minimum of Two (2) years.

Version: 1

Definitions CBOC – Community Based Outpatient Clinic

POC – Point of Care

QC- Quality Control

CPRS – Computerized Patient Record System

Responsibilities A. Clinic personnel from Community Based Outpatient Clinics (Victorville, Murrieta, Palm Desert, Corona and Rancho Cucamonga) Including:

• Physicians

• Registered Nurses

• License Vocational Nurse and

• Certified nursing assistant

• Medical Assistant are responsible for:

1. Running 2 levels of Quality Control once a month and/or before patient testing.

2. Documenting Quality Control results on the quality control log.

3. Monitoring and documenting temperature including room temperature where reagents are stored.

4. Documenting patient results at the site Sharepoint.

5. Entering patient results at the electronic patient log through Accuchek

Inform II entry.

6. Entering patient results in CPRS under Point of Care template for urine pregnancy if Accuchek Inform II entry is not available.

7. Maintaining original documents such as Quality Control log and patient results log if any for 2 years.

8. Making sure that the Quality Control logs reviewed and signed off at the end of the month by the site CLIA director.

B. Ancillary Testing Coordinator from Pathology and Laboratory Medical

Service is responsible for:

1. Monthly review of electronic patient log on Sharepoint.

2. Quarterly site visit to do Point of Care audit, including QC logs.

3. Review, update and implement Policy and Procedure as needed.

4. Attend monthly CBOC meeting to communicate changes and/or updates regarding Point of Care testing.

Special Notes Precaution – All human body fluid should be handled with precautions and considered as infectious.

Observe Universal Precautions during processing of specimens and control materials:

• Use Universal Protective Equipment, including gloves.

• Wear Goggles or eye protection during procedures that could generate splashes.

• Wash hands after removal of gloves.

Sample Urine (preferable first morning):

• Urine specimens may be collected in any clean, dry plastic container.

• For early detection of pregnancy, the first morning specimen of urine is recommended since it usually contains the highest concentration of hCG.

• No centrifugation or filtration of ‘clear’ specimens is mandatory for testing, however, particulate matter in specimens should be allowed to settle (or be centrifuged) before removing a sediment-free sample for analysis.

• Cloudy samples may interfere with the reading and should be avoided.

• Gross hematuria may prevent an accurate reading of test results by masking any lines.

• If urine’s supernatant is red, do not perform the test and ask for a recollection or place an order for serum pregnancy testing, draw blood to be sent to the laboratory or send patient to the laboratory.

Materials Equipment:

Instruments

Accuchek Inform II Meter

Supplies

1. Test kits: Sure-Vue hCG STAT;

Ø Test device: With monoclonal mouse-hCG colored conjugate and hCG antibody coated on a membrane.

Ø Disposable specimen dropper: Plastic (Not calibrated;

used to dispense 4 drops or about 0.15 ml of sample)

2. Materials needed, but not provided with kit:

Ø Specimen collection tube or container Ø External quality control materials Ø Timer

3. Storage and Expiration:

Ø Store the test kit at room temperature (15º - 30ºC) for the duration of its shelf-life.

Ø Each test device must remain “sealed” in its individual pouch until ready for use.

Ø Kit contents are stable until the expiration date printed on the box.

Ø DO NOT use after the expiration date.

4. Disposal:

Ø The used test device, pipet and specimen collection container are to be discarded in a biohazard container.

Quality Control

1. Level 1 and level 2 controls and/or as needed before patient testing is done.

2. Liquid Controls are stable until expiration date when stored at 2° to 8°C.

3. Opened Liquid Controls are good for one month.

4. Controls must be at room temperature before use.

5. Results must be acceptable and will be documented on the control log.

6. Liquid Controls must be returned immediately to refrigerator after testing.

7. DO NOT perform patient testing if liquid controls fail, call Ancillary Testing

Coordinator immediately at 909-503-2865.

• Negative control = Quantimetrix Dropper Plus Level 1, Negative control Expected result = Negative only

• Positive control = Quantimetrix Dropper Plus Level 2, Positive control Expected result = Positive only

Procedure:

Control Testing

1. Remove 2 test device and disposable plastic pipet from the pouch and place on a clean flat surface.

2. Label each device with control identification, Ctl 1 and Ctl 2.

3. Dispense 3 drops of control solution into the round sample well.

Note: Make sure to use the controls that matches the label on the device.

4. Start timer

5. Read at 3 minutes.

6. Interpret results as follows;

• Negative: Control region will have a solid purplish-pink line Patient region will have no apparent line.

• Positive: Control region will have a solid purplish-pink line Test region will have a distinct purplish-pink line

• Invalid: Control line fails to appear.

Invalid Result/s: DO NOT report result repeat testing on a new testing device.

If testing device continues to fail, DO NOT RUN PATIENT SAMPLES call Ancillary Testing Coordinator at 909-503- 2865 immediately for further instructions.

7. Document results on the QC/Patient Log accordingly.

Patient Testing

1. Print 2 labels containing full name and full SS# of the patient.

2. Remove test device and disposable plastic pipet from the pouch and place on a clean flat surface.

3. Label each device with printed label .

4. Dispense 3 drops of urine specimen into the round sample well.

Use a new plastic pipet for each sample or control.

5. Start timer

6. Read at 3 minutes

7. Interpret results as follows;

• Negative: Control region will have a solid purplish-pink line Patient region will have no apparent line.

• Positive: Control region will have a solid purplish-pink line Test region will have a distinct purplish-pink line

• Invalid: Control line fails to appear.

Invalid result/s: DO NOT report result, repeat testing on a new testing device.

If testing device continues to fail, DO NOT RUN PATIENT SAMPLES call Ancillary Testing Coordinator at 909-503- 2865 immediately for further instructions

7. Document results on the QC/Patient Log accordingly.

8. Enter results in the Accuchek Inform II

• Turn Accuchek Inform II on

• Scan access code accordingly

• Select “Patient Testing” from the main menu

• Select “Other Test”

• Select “Pregnancy”

• Enter Patient’s FULL SOCIAL NUMBER

• Confirm “Date Tested” is correct

• Confirm “Time Tested” is correct

• Scan “Pregnancy Kit Lot Number”

• Enter Expiration Date

• Confirm “Patient ID” before entering results

• Confirm that all results are correct before accepting.

• Return Accuchek Meter to the docking station.

9. Or document results in POC CPRS pregnancy template if

Accuchek Inform II is not available.

• Log in to CPRS

• Under “File” select your patient

• Type the FULL SOCIAL NUMBER of the patient

• Click “OK”

• Click “New Template” then OK

• Click on the box for “Point of Care/Ancillary Testing”.

• Look for “Pregnancy Testing” then click box.

• Fill in template, then sign.

Expected Values

Negative

Positive

Interpretation and Results

Negative: Control region will have a solid purplish-pink line Patient region will have no apparent line.

Positive: Control region will have a solid purplish-pink line

Test region will have a distinct purplish-pink line

Invalid: Control line fails to appear.

Method Limitations

1. This test provides a presumptive diagnosis of pregnancy. A confirmed regnancy diagnosis should only be made by a physician after all clinical and laboratory findings have been evaluated.

2. Clinicians must maintain a high index of suspicion if there is a concern for early pregnancy and should follow the established protocols to determine when it is needed to proceed to a serum pregnancy.

3. Ectopic pregnancies may produce very low levels of hCG. If this condition is suspected, further testing using a quantitative test is recommended although, normal pregnancy cannot be distinguished from an ectopic pregnancy based solely on hCG levels. Abnormally high levels of hCG may be seen in molar pregnancies. Samples from abnormal pregnancies are beyond the intended use for qualitative hCG tests such as this one.

4. Elevated levels of hCG may be found in trophoblastic disease, choriocarcinoma, islet cell tumors and embryonal cell carcinoma.These conditions may cause a positive result.

5. Detectable levels of hCG may remain several weeks following normal pregnancy, delivery by Caesarean section, spontaneous or therapeutic abortion.Approximately one third of all conceptions end in natural termination.

This may produce positive results when testing early in the pregnancy followed by negative results after the natural termination. Low positive results may be confirmed by retesting with a new sample collected 48 hours later.

6. Women receiving very high levels of fertility drugs (LH or FSH at higher than those levels showing no cross-reactivity) may exhibit false positive results.

7. Patients with rheumatoid factor may exhibit false positive results.

8. A viscous specimen (high specific gravity) may exhibit a slower flow rate, therefore such specimens must be sent to the main laboratory for testing.

9. A high dose “hook effect” may occur where the intensity of sample line decreases as the concentration of hCG increases. If a “hook effect” is suspected, draw blood and send the specimen to the main laboratory for testing or place an order and send patient to the laboratory.

10. If urine specimens have a low specific gravity (i.e., very dilute), they may not have representative levels of hCG. If pregnancy is still suspected the test may be repeated using the first morning urine specimen, or place an order and send patient to the lab for serum testing.

References

1. Sure-Vue Package Insert, DN: 1155810102, 2007-11-15.

2. VHA Handbook 1106.01, October 06, 2008, Pathology and Laboratory Medicine

Services Directive.

3. JC, Comprehensive Accreditation Manual for Laboratory and Point of Care

Testing, January 2008

Related Documents

8-102-ATT1 Quality Control Log

Review and Approval of Site Clinic Director

Name & Title (Role) Date

Signature

Reviewed and Approved By:

Reviewed and Approved By:

Date