Point-of-Care Testing (POCT)
Point-of-Care Testing (POCT) allows rapid diagnostic testing during the patient visit, supporting timely clinical decision-making and improved patient care. Proper specimen collection, quality control, documentation, and infection prevention are essential to producing accurate and reliable test results.
Purpose
This SOP establishes standardized procedures for performing CLIA-waived point-of-care testing while ensuring patient safety, specimen integrity, accurate documentation, and regulatory compliance.
All testing must be performed according to manufacturer instructions, clinic policy, and applicable CLIA regulations. Staff may only perform tests for which they have completed competency validation and training.
Responsibilities
Medical Assistants
Verify patient identity, collect specimens correctly, perform approved waived testing, document results, and immediately report abnormal or critical findings to the provider.
Providers
Order appropriate testing, interpret results, communicate treatment plans, and determine when confirmatory laboratory testing is indicated.
Leadership
Maintain CLIA compliance, oversee quality assurance, verify competency completion, and monitor testing documentation.
All Clinical Staff
Follow infection prevention standards and manufacturer instructions during all point-of-care testing procedures.
Standard POCT Workflow
Verify the Order
Confirm the provider has ordered the correct point-of-care test before collecting any specimen.
Identify the Patient
Use two patient identifiers according to the Patient Identity Verification SOP before obtaining any specimen.
Perform Hand Hygiene & Prepare Supplies
Complete hand hygiene, gather the correct testing kit, verify expiration dates, and inspect supplies for damage before beginning.
Collect the Specimen
Collect the specimen according to manufacturer instructions while maintaining patient comfort, proper technique, and specimen integrity.
Perform the Test
Complete all testing exactly as instructed by the manufacturer, including timing requirements and reagent usage.
Read Results
Interpret results only within the manufacturer's approved reading window. Results read too early or too late are considered invalid.
Common Point-of-Care Tests
The Neighborhood Clinic performs a variety of CLIA-waived point-of-care tests. Always follow the manufacturer's instructions for the specific testing device being used.
Urinalysis (UA)
Verify specimen labeling, inspect urine quality, perform dipstick testing within the required timeframe, and document results accurately in RXNT.
Urine Pregnancy Test
Use a fresh specimen whenever possible and interpret results only during the manufacturer's approved reading window.
Rapid Strep
Obtain an adequate throat specimen using proper collection technique while avoiding contamination.
Influenza / COVID-19
Collect nasal specimens according to manufacturer instructions while following appropriate infection prevention precautions.
Hemoglobin A1C
Perform fingerstick collection using approved lancets and follow analyzer instructions exactly.
Blood Glucose
Verify meter readiness, use a clean fingerstick technique, and confirm quality control requirements have been completed.
Quality Control (QC)
Quality control ensures testing equipment and reagents are functioning properly. QC must be completed according to manufacturer recommendations and clinic policy.
• Test kit is not expired.
• Packaging is intact.
• Required quality controls have passed.
• Equipment is functioning properly.
• Environmental storage requirements have been maintained.
Invalid or Unexpected Results
Verify the Test
Confirm the specimen was collected correctly, testing steps were followed, and the result was interpreted within the approved time frame.
Repeat When Appropriate
If permitted by manufacturer instructions, repeat the test using a new testing device and specimen when clinically appropriate.
Notify the Provider
Immediately communicate abnormal, unexpected, or critical results to the ordering provider for further evaluation.
Document the Outcome
Record final results, repeat testing when applicable, provider notification, and any follow-up instructions in RXNT.
RXNT Documentation
Test Ordered
Verify the provider's order before documenting completed testing.
Results
Document the exact test result, including positive, negative, numeric values, or other manufacturer-defined reporting terminology.
Provider Notification
Document when abnormal or critical findings were communicated to the provider.
Patient Education
Record any education, treatment instructions, or follow-up recommendations provided to the patient.
Specimen & Waste Disposal
Dispose of all used testing materials according to OSHA, CLIA, and clinic infection prevention policies.
Sharps
Dispose of lancets and needles immediately into approved sharps containers.
Biohazard Waste
Discard contaminated swabs, collection devices, and testing materials into designated biohazard containers.
Hand Hygiene
Perform hand hygiene immediately after specimen handling and waste disposal.
Do & Don't
✔ Always
• Verify two patient identifiers.
• Follow manufacturer instructions exactly.
• Check expiration dates before use.
• Complete quality control requirements.
• Document results promptly.
• Notify providers of abnormal findings.
✖ Never
• Use expired testing supplies.
• Read results outside the approved time window.
• Guess at unclear results.
• Skip quality control procedures.
• Delay documenting completed testing.
Employee Competency
- Performs only approved CLIA-waived testing within assigned competency.
- Correctly verifies patient identity before specimen collection.
- Collects and handles specimens appropriately.
- Follows manufacturer instructions for each testing device.
- Completes required quality control procedures.
- Accurately documents results in RXNT.
- Recognizes invalid or critical results and notifies the provider promptly.
- Maintains OSHA, CLIA, and infection prevention compliance.