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Point-of-care testing and shipping specimens

14 min

Skills you'll build

  • Check operator, reagent, device, and control readiness before point-of-care testing
  • Match a test's CLIA complexity to the certificate that covers it
  • Choose safe packaging and handling for a specimen shipment

At the bench: Check operator, reagent, and control readiness for point-of-care testing

Read the full reference

Try first

Try first

A nurse floated from another unit needs a bedside glucose. The unit's meter passed QC this morning and its strips are in date. The nurse has never been trained or authorized on this meter model. What happens?

Right. Keep going to follow the reasoning.

Keep going to build the reasoning.

Keep going to build the reasoning.

Keep going to build the reasoning.

Get the idea

Use the explanation to check your first decision.

Point-of-care testing (POCT) moves a laboratory test to the bedside, clinic or unit. The result still goes out under a laboratory certificate. Three checks keep it sound:

  • whether the system is ready
  • whether the certificate covers the test
  • when a specimen has to travel, whether it is packed to travel safely

Readiness

Readiness has four parts in a site's POCT procedure, and all four are checked before a patient is tested. Each has to pass on its own:

  • The operator is trained and authorized for that system at that site.
  • The strips or cartridges are in date, stored within their limits and within any open-vial dating. Supplies past their expiration date are not used.2
  • The device has its maintenance done and shows no error.
  • Required QC has been run and is acceptable.

Scope

  • The Food and Drug Administration (FDA) sorts each commercial test system into a Clinical Laboratory Improvement Amendments (CLIA) category: waived, moderate complexity or high complexity. Waived tests are simple tests with a low risk of a wrong result.
  • Where a test is performed does not change its category.
  • A test run outside the manufacturer's instructions, for example on a specimen type the instructions exclude, counts as modified. Modified tests default to high complexity.1
  • A site with a Certificate of Waiver may perform only waived tests, so a modified test is outside its certificate.2

Shipping

A patient specimen that may contain a pathogen travels to another laboratory as UN3373, "Biological substance, Category B." US transport rules exempt some specimens, such as those sent for routine testing unrelated to infectious disease with a low probability of being infectious. The laboratory's shipping procedure sets the classification.5

A UN3373 package needs triple packaging:3,4

LayerRequirement for a liquid specimen
Primary receptacleLeakproof, closed tube or container
AbsorbentBetween primary and secondary, enough to take up the entire liquid contents
Secondary packagingLeakproof, holding the primary so it cannot break or leak into it
Outer packagingRigid, cushioned, marked with the UN3373 diamond and the shipping name

Each layer does a separate job, so one missing layer lets a leak reach the courier. Air shipment adds pressure and quantity limits, and a trained shipper does the final classification and packing.3

Follow the bench demonstration

Sources for this step
References
  1. Centers for Disease Control and Prevention. Test complexities. Accessed September 23, 2026.
  2. Electronic Code of Federal Regulations. 42 CFR part 493: Laboratory Requirements. Accessed September 23, 2026.
  3. Electronic Code of Federal Regulations. 49 CFR §173.199: Category B infectious substances. Accessed September 23, 2026.
  4. Pipeline and Hazardous Materials Safety Administration. Transporting infectious substances overview. Accessed September 23, 2026.
  5. Electronic Code of Federal Regulations. 49 CFR §173.134: Class 6, Division 6.2—definitions and exceptions. Accessed September 23, 2026.

Watch one

Follow each move and the reason beside it.

At 09:00 an authorized nurse is about to run a bedside glucose.

  • The meter's controls were acceptable yesterday on strip lot 4471.
  • This morning a new box from strip lot 4502 was opened and loaded.
  • The unit's procedure requires controls with each new strip lot.

May the nurse test the patient now?

  1. Check the nurse's authorization for this meter on this unit: current.

    The operator is the part of readiness the device cannot show.

  2. Check strip lot 4502: in date, stored at room temperature as labeled, opened today.

    Expired or badly stored strips give wrong results even on a working meter.

  3. Check the meter: no error codes, cleaning log current.

    A device showing an error or overdue maintenance is not ready, whatever its QC.

  4. Check QC for lot 4502: none has been run.

    Yesterday's QC was on lot 4471, so it says nothing about the new lot, and the procedure requires controls for it.

  5. Run both control levels with lot 4502 and confirm they are acceptable before testing the patient.

    Acceptable QC on the new lot completes readiness.

Not yet. Run the required controls on strip lot 4502. Once they are acceptable, the nurse tests the patient.

Practice this skill

Your turn

Problem 1 of 3 · Hints available

A point-of-care glucose meter's required control is outside its acceptable limits at the start of a shift. What does the operator do before testing patients?

Incorrect. Repeating until a value passes hides the failure. Its cause, such as a mishandled strip lot or control, is still present and can affect patient results.

Correct. Acceptable required QC is part of device readiness. The operator investigates the failure, documents the correction, and returns the meter to patient testing once QC is acceptable.

Incorrect. A meter that has failed required QC is not ready for patient testing, and a later confirmation does not make its results reportable.

Hint
  1. Acceptable required QC is part of whether the device is ready.
  2. A control that passes on a later try still leaves the first failure unexplained.

Review Oversight of a distributed testing program

Problem 2 of 3 · Hints available

A test is performed beside the patient. What establishes whether it is CLIA-waived?

Incorrect. Point of care describes where testing happens. Moderate- and high-complexity systems are also used near patients, and they carry their full nonwaived requirements there.

Correct. FDA categorizes each commercial test system, for its intended use and instructions, as waived, moderate, or high complexity. Testing location does not set complexity.

Incorrect. Waived status reflects simplicity and a low risk of an erroneous result. A fast result can come from a moderate-complexity system.

Hint
  1. Think about who assigns a test its CLIA category.
  2. Moderate- and high-complexity systems are used at the bedside too.

Review Test complexity and certificate scope

Problem 3 of 3 · On your own

You are packing a tube of serum for shipment to a reference laboratory as UN3373. Put the packing steps in order, from the tube outward.

  1. Close the tube tightly so the primary receptacle is leakproof
  2. Cushion the secondary bag inside the rigid outer box
  3. Seal the wrapped tube inside the leakproof secondary bag
  4. Wrap the tube in absorbent material enough to take up all of the serum
  5. Mark the outer box with the UN3373 diamond and the proper shipping name
Show the answer

Close the tube tightly so the primary receptacle is leakproof, Wrap the tube in absorbent material enough to take up all of the serum, Seal the wrapped tube inside the leakproof secondary bag, Cushion the secondary bag inside the rigid outer box, Mark the outer box with the UN3373 diamond and the proper shipping name

Tube, absorbent, leakproof secondary, rigid outer box, then the mark on the outside. The absorbent sits between the primary and the secondary so a leak stays inside the secondary.

Review Specimen transport and waste

Use it

Read the case evidence, then make each decision.

  • A family medicine clinic holds a Certificate of Waiver and runs a waived hemoglobin meter whose instructions list capillary and venous whole blood from adults.
  • The nurse manager wants to start testing heel-stick specimens from newborns on the same meter, which the instructions exclude.
  • The same morning, a venous blood specimen for a hepatitis C RNA test has to go to a reference laboratory by commercial courier. The clinic's shipping procedure classes it as UN3373.
  • The medical assistant has placed the capped tube in a sealed leakproof bag and put the bag in a padded paper envelope.
Decision 1 of 2

What do you tell the nurse manager about newborn testing on this meter?

Using a specimen type the instructions exclude modifies the test. A modified test defaults to high complexity, which a Certificate of Waiver does not cover.

Modified a waived test and kept it under the waiver

A modification that affects performance makes a waived test high complexity, which a Certificate of Waiver does not cover. Testing then continues under the wrong certificate, without the performance studies, personnel, and QC that high complexity requires.

QC shows the meter works as designed. It cannot bring an off-label specimen type back inside the waived category or the certificate.

Running outside the instructions makes the test high complexity, and the clinic's certificate covers waived testing only.

Review Test complexity and certificate scope

Decision 2 of 2

Is the send-out specimen ready for the courier?

The capped tube and the sealed bag cover the primary and secondary layers. Absorbent and a rigid, marked outer package are still missing.

Two layers are in place. Nothing is there to absorb a leak, and a padded envelope is not a rigid outer package.

Left a layer out of a Category B package

A Category B specimen needs a leakproof primary receptacle, leakproof secondary packaging, enough absorbent for the liquid, and a rigid outer package. Leaving out any layer lets a leak reach couriers and the public and breaks the shipping rules.

Refrigerant depends on the test's stability requirements. The missing packaging layers are the problem here.

Review Specimen transport and waste

Both decisions turn on what is written down:

  • The meter's instructions name the specimens it was cleared for. Newborn heel-sticks are not among them, which settles the certificate question.
  • The packaging rule names four layers. Counting them shows two missing before the courier arrives.

For reference

Sources checked