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newSchoolWorks.com › VoTechWorks › Health & Personal Services › Phlebotomy Technician › Specimen Handling and Processing for Phlebotomy Technicians › Lesson 11
HLT-PHLE88-04 · Lesson 11 · 6 clock hours · lab

Point-of-Care Testing: Instrument Operation and Quality Control

Objective. Students will perform a point-of-care test on a training instrument, run the required quality control check, and document both results on the appropriate log according to standard operating procedure.

⚠ Pending professional review

This lesson, its worked examples and its practice questions has not yet been verified by a licensed clinician in the field or by a certification or approval body. It is a study draft and may contain errors. Do not use it to make decisions about any patient or medication. Always follow your instructor, your supervising professional, and current official references and regulations.

VoTechWorks program approval and accreditation are still in progress. Credentials are issued only by the certifying bodies named in each program, after their own exams.

What Is Point-of-Care Testing?

Point-of-care testing (POCT) means laboratory testing performed at or near the patient—at the bedside, in a clinic exam room, or in a physician's office—rather than in a central laboratory. A handheld glucose meter is the most common example. POCT gives rapid results that support fast clinical decisions, but that speed comes with responsibility: the phlebotomy technician or other operator must follow a strict standard operating procedure (SOP) every single time to keep results accurate and patients safe.

As a phlebotomy technician, your scope of practice for POCT is determined by your employer's policy and your state's regulations. In many settings you will be authorized to operate approved POCT instruments, run quality control, and document results. You will not interpret results medically or advise patients on treatment—that responsibility belongs to licensed clinical staff.

The Glucose Meter: How It Works

A handheld glucose meter measures blood glucose concentration using an enzymatic reaction on a single-use test strip. A tiny drop of whole blood (or, in training, a control solution) is applied to the strip, which is inserted into the meter. The meter reads the electrical signal produced by the reaction and displays a glucose value, typically in milligrams per deciliter (mg/dL).

Each meter is a specific model with its own approved strips and quality control (QC) materials. You must never mix strips or controls from one manufacturer with another brand's meter. Always confirm that the strip lot number matches the code in the meter or the code chip, according to the instrument's SOP.

Quality Control: Why It Is Not Optional

Quality control is the process of testing solutions of known concentration to verify that the instrument and strips are performing correctly before you test a patient sample. Regulatory standards and accreditation bodies require QC to be run at defined intervals—at minimum, when you open a new lot of strips, when the instrument is first put into service each day, after certain maintenance events, and whenever results seem questionable.

Liquid QC materials come in at least two levels:

Running both levels confirms that the meter responds accurately across the range of values it may encounter in patients.

Reading the Control Insert

Every bottle of liquid QC material ships with a package insert (sometimes called the control insert or value sheet). The insert lists the acceptable range for each control level for each specific meter model. The range is usually printed as a lower limit and an upper limit, for example: Low Control: 45–75 mg/dL; High Control: 280–360 mg/dL.

After you run a control, compare your result to the range on the insert for your specific meter model. The result is in range (acceptable) if it falls on or between the two limits. The result is out of range if it falls below the lower limit or above the upper limit.

If either control is out of range, stop. Do not test patients. Follow your facility's troubleshooting steps: check strip expiration, check control expiration, confirm proper storage, repeat the control, and notify your supervisor. Document all troubleshooting actions.

Step-by-Step: Running Quality Control

1. Wash hands and put on gloves.

2. Gather the meter, strips, low and high QC bottles, the control insert, and the QC log form.

3. Insert a fresh strip into the meter; confirm the lot code matches.

4. Mix the low control solution gently (invert or swirl as directed; do not shake vigorously).

5. Apply the low control to the strip as you would a blood drop.

6. Read and record the result on the QC log immediately.

7. Compare the result to the low control acceptable range on the insert. Record Pass or Fail.

8. Repeat steps 3–7 with the high control.

9. If both controls pass, you may proceed to patient testing. If either fails, troubleshoot and document.

Step-by-Step: Performing a Simulated Patient Test

In training you will use a control material as a mock patient specimen. In real practice you would use a capillary blood sample collected by fingerstick.

1. Confirm QC is documented and both levels passed before proceeding.

2. Insert a fresh strip; confirm lot code.

3. Apply the training specimen to the strip.

4. Read and record the result on the POCT documentation form.

5. Complete all required fields: date, time, operator ID, patient ID (or training ID), meter ID, strip lot number, control lot numbers, control results, and patient result.

No field on a required documentation form is optional. A blank field is a documentation error.

Safety Points

Key terms9

Point-of-care testing (POCT)Laboratory testing performed at or near the patient rather than in a central laboratory, providing rapid results to support immediate clinical decisions.
Quality control (QC)The process of testing solutions of known concentration to verify that an instrument and reagents are performing within acceptable limits before patient samples are tested.
Liquid QC materialA commercially prepared solution containing a known concentration of analyte (such as glucose) used to verify instrument performance; supplied in low and high levels.
Control insert (value sheet)The package insert included with QC material that lists the acceptable result range for each control level on each compatible instrument model.
Acceptable rangeThe lower and upper limits published by the QC manufacturer within which a control result must fall for the instrument run to be considered valid.
Standard operating procedure (SOP)A written, step-by-step document that specifies exactly how a test or process must be performed in a given facility to ensure consistent, accurate, and safe results.
Lot numberA manufacturer's alphanumeric code identifying a specific batch of reagent strips or control material; operators must verify and record lot numbers to ensure traceability and correct range assignment.
Operator IDA unique identifier (such as an employee number or initials) recorded on POCT documentation to establish accountability for each test performed.
TroubleshootingThe systematic process of identifying and correcting the cause of an out-of-range QC result before resuming patient testing, including checking expiration dates, storage conditions, and technique.

Worked examples4

1. You run the low control on a glucose meter and get a result of 52 mg/dL. The control insert lists the acceptable range for the low control as 48–68 mg/dL. Is this result acceptable?
  1. Identify the lower limit: 48 mg/dL.
  2. Identify the upper limit: 68 mg/dL.
  3. Compare the result (52 mg/dL) to the limits: 52 is greater than or equal to 48 and less than or equal to 68.
  4. Because 52 falls within the range 48–68, the result is within the acceptable range.
Answer: The result is acceptable (in range). You may proceed to the high control.
2. You run the high control and get a result of 375 mg/dL. The control insert lists the acceptable range for the high control as 290–360 mg/dL. Is this result acceptable, and what should you do?
  1. Identify the lower limit: 290 mg/dL.
  2. Identify the upper limit: 360 mg/dL.
  3. Compare the result (375 mg/dL) to the upper limit: 375 is greater than 360.
  4. The result exceeds the upper limit, so it is out of range.
  5. Do not proceed to patient testing. Document the out-of-range result on the QC log, begin troubleshooting per SOP (check strip lot/expiration, control expiration, storage conditions, technique), and notify your supervisor.
Answer: The result is out of range (375 > 360). Stop patient testing, troubleshoot, document all actions, and notify a supervisor before retesting.
3. A QC log has space for six fields: Date, Time, Operator ID, Strip Lot Number, Control Lot Number, and Result. You completed the QC run but forgot to record the strip lot number. How many required fields are complete, and is the documentation acceptable?
  1. Count the total required fields: 6.
  2. Count the fields you completed: Date ✓, Time ✓, Operator ID ✓, Strip Lot Number ✗ (missing), Control Lot Number ✓, Result ✓ — that is 5 of 6 complete.
  3. A missing required field is a documentation error regardless of how many other fields are filled.
  4. Return to the log immediately, locate the strip packaging (or retrieve the lot number from the open strip vial if still available), and add the missing lot number with your initials and the time of correction per your facility's policy.
Answer: 5 of 6 fields are complete. The documentation is not acceptable as written. Correct the omission immediately following your facility's late-entry or correction policy; do not leave required fields blank.
4. Your low control acceptable range is 45–75 mg/dL and your high control acceptable range is 280–360 mg/dL. Low control result: 45 mg/dL. High control result: 280 mg/dL. Are both controls acceptable?
  1. Low control: compare 45 mg/dL to the range 45–75 mg/dL. The lower limit is 45; the result equals the lower limit. A result equal to a limit is within the range.
  2. High control: compare 280 mg/dL to the range 280–360 mg/dL. The lower limit is 280; the result equals the lower limit. A result equal to a limit is within the range.
  3. Both results are on a boundary of their respective ranges, which counts as in range (acceptable).
Answer: Yes, both controls are acceptable. Boundary values (equal to the lower or upper limit) are considered within range. You may proceed to patient testing.
In class: Instructor demonstrates operation of a point-of-care glucose meter (or equivalent training instrument): running liquid quality control at low and high levels, recording results, and determining whether the run is within acceptable range before testing a patient sample. · Students each perform a quality control run on the training instrument, record results on a QC log, compare to the acceptable range printed on the control insert, and decide whether to proceed or troubleshoot. · Students perform a simulated patient test using a training specimen (glucose control material used as mock patient), record the result, and complete the full point-of-care testing documentation form including operator ID, lot numbers, and control results.
Materials: Point-of-care glucose meter (or designated training instrument), liquid quality control materials (low and high), control insert with acceptable ranges, lancets or simulator, QC log form, POCT documentation form, gloves
Check: Instructor observation checklist: student must correctly run both control levels, accurately interpret acceptability, and complete all documentation fields—any skipped required field or misinterpretation of out-of-range QC is a failure requiring repeat.

Practice check8

Answer each question, then check it. Nothing is recorded; this is your own practice.

Specimen Collection and Processing
1. Before testing a patient's blood glucose with a handheld meter, the phlebotomy technician must first:
Specimen Collection and Processing
2. A technician runs the low control and obtains a result of 40 mg/dL. The control insert lists the acceptable range for the low control as 48–68 mg/dL. What is the correct next action?
Specimen Collection and Processing
3. The package insert included with liquid QC material is used to:
Safety and Compliance
4. Which of the following best describes the phlebotomy technician's scope of practice when a POCT glucose result is unexpectedly high for a patient who appears symptomatic?
Safety and Compliance
5. When completing a POCT documentation form, the operator ID field is left blank. This is best described as:
Specimen Collection and Processing
6. Why must the strip lot number be verified against the acceptable range listed on the control insert before running quality control?
Safety and Compliance
7. A used lancet after a fingerstick procedure must be disposed of by:
Specimen Collection and Processing
8. A technician's high control result is 358 mg/dL and the acceptable range listed on the insert is 290–360 mg/dL. The low control result was 60 mg/dL with an acceptable range of 45–75 mg/dL. What should the technician do?
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