Purpose & Scope

This manual is the print-and-reference companion to a self-contained SCORM 1.2 e-learning course, Laboratory Quality Control Fundamentals. It is not a substitute for the course, and it is not a regulatory standard in itself — it is a bridge between the two.

What this manual covers

The manual has three jobs. First, it explains what the accompanying course does and does not teach, so training coordinators can decide where it fits in a broader QC curriculum. Second, it walks an LMS administrator through installing and tracking the SCORM package on their own platform. Third, it reproduces the core reference content of the course — control theory, statistical QC, Westgard rules, out-of-control response, and documentation expectations — in a linear, searchable, printable form that works as a standalone job aid long after the course itself has been completed.

What this manual is not

Intended audience

Relationship to LabCourses

This manual and its accompanying course are published as part of LabCourses, LabLynx's training and certification add-on application. The course itself is a standards-based SCORM 1.2 package, so it can be delivered through LabCourses or imported into any other SCORM 1.2-compliant learning management system your organization already uses — it does not require LabCourses to run.

How to Use This Manual With the Course

The manual and the course cover the same eight topics, but they are built for different moments: the course for first-pass, interactive learning; the manual for lookup, review, and citation afterward.

Recommended workflow

1. Assign the course first. The SCORM package is interactive — it includes a clickable Levey-Jennings chart and a scored knowledge check that reports a pass/fail mastery score back to your LMS. That interactivity is best experienced before reading the equivalent reference material.
2. Use the manual for review and lookup. Once a learner has completed the course, this manual becomes the thing they actually keep open on a second monitor during their first weeks running QC independently — searchable, linear, and printable.
3. Use the manual for onboarding documentation. Because it is a standalone HTML file, it can be attached to an onboarding checklist, linked from an SOP, or printed for a training binder without needing LMS access.

Chapter-to-module correlation

Every content module in the course has a directly corresponding chapter in this manual, so a learner or auditor can move between the two without hunting for equivalent material.

Inside the SCORM Package

The course is packaged to the SCORM 1.2 standard, the most widely supported e-learning interoperability standard across commercial and open-source learning management systems.

Package Contents & Manifest

The download in Chapter 4 is a single .zip archive built as a standard SCORM 1.2 content package. Its manifest (imsmanifest.xml) declares one organization containing one SCO (shareable content object):

Installing in Your LMS

Because it follows the SCORM 1.2 standard, the package installs the same way any SCORM 1.2 course does in a compliant LMS. Exact menu names vary by platform, but the sequence is consistent:

1. Download the .zip package from Chapter 4 — do not unzip it. Most LMS platforms expect the packaged .zip as-is.
2. In your LMS, locate the course or content import function (commonly labeled "Add Content," "Import Package," "Upload SCORM Package," or similar).
3. Select SCORM 1.2 as the package type if your LMS asks you to specify a standard rather than auto-detecting it from the manifest.
4. Upload the .zip file directly. The LMS will read imsmanifest.xml to register the course title, organization, and mastery score automatically.
5. Assign the resulting course to the appropriate learners, groups, or roles as you would any other course in your catalog.

Tracking & Completion Data

The course reports standard SCORM 1.2 CMI data elements back to the LMS as the learner progresses:

• cmi.core.lesson_status — set to incomplete on first launch, and to passed or failed once the knowledge check is submitted, based on the 80% mastery threshold.
• cmi.core.score.raw / min / max — the learner's knowledge-check score, reported on a 0–100 scale.
• cmi.core.lesson_location — the last section the learner viewed, so progress resumes correctly if the learner exits and re-launches later.
• cmi.core.session_time — time spent in the current session, recorded on exit and before the browser unloads the page.

Because progress is tracked at the section level and committed continuously, a learner who exits mid-course and relaunches later returns to the same section rather than starting over.

Download the Course Package

The button below downloads the complete SCORM 1.2 package as a single .zip file, ready to import into your learning management system exactly as described in Chapter 3.

What Is Laboratory Quality Control?

Every result a laboratory reports rests on one quiet assumption: that the test system producing it was working correctly at the time. Quality control is how a lab earns the right to make that assumption.

Quality control is the practice of testing a material with a known, expected result alongside patient samples, to confirm the test system is performing within acceptable limits before those patient results are released.

Three related but distinct activities

It is easy to blur quality control together with two neighboring concepts. They serve different purposes and run on different schedules.

QC answers a narrow, urgent question: right now, can I trust what this instrument is telling me? The rest of this manual is really about answering that question well.

Control Materials & Levels

A control is a sample manufactured to behave like a patient specimen but with a value the lab already knows, within a defined range.

Running a control tells you whether the instrument, reagents, and technique are behaving as expected — independent of any single patient's result.

Why multiple levels?

Most tests run at least two levels of control — commonly a normal and an abnormal (high or low) level, and often a third mid-range level for wider assays. A method can be accurate at a normal concentration and still drift at the high or low end; a single level would miss that entirely.

Matrix matters

Control material should behave like the specimen type it is standing in for — serum, whole blood, urine — so it responds to the same analytical conditions patient samples do. A mismatch in matrix can mask or exaggerate a problem that would otherwise be caught.

New lot verification

Every control lot has its own manufacturer-assigned range, but that range must be verified against the lab's own instrument and reagents before use. Standard practice is to run the new lot in parallel with the current lot — typically over about 20 data points — to establish the lab's own mean and standard deviation before the old lot expires.

QC Frequency & Scheduling

How often QC runs depends on the test, the instrument, and applicable regulatory or accreditation requirements — there is no single universal schedule.

The schedule is usually documented in the test's standard operating procedure (SOP), and any deviation — a missed QC run, a late start — should itself be documented, since gaps in QC coverage are exactly what auditors look for.

Statistical QC Basics

Once enough control results accumulate, the lab can describe how that control material actually behaves on its own system — not just whether a single result looks right.

Mean & Standard Deviation

The mean is the expected center value for a control, established from accumulated results. The standard deviation (SD) describes how much individual results normally scatter around that center. Together they define the boundaries used to judge whether a new result looks routine or unusual.

Coefficient of Variation

The coefficient of variation (CV%) expresses that scatter as a percentage of the mean, which makes it possible to compare precision across analytes measured on very different scales:

The Levey-Jennings Chart

A Levey-Jennings chart plots each control result, run after run, against horizontal lines marking the mean and the ±1SD, ±2SD, and ±3SD boundaries. It turns a column of numbers into a shape you can read at a glance — scatter, drift, and sudden jumps all become visible immediately.

Static illustration for reference. The course's version of this chart is interactive — clicking any point shows how it reads against the control limits and which Westgard rule, if any, it would trigger.

Westgard Multirules

A single control result outside ±2SD happens by chance around 1 in 20 runs, purely from normal scatter. Rejecting a run every time that happens would be needlessly disruptive — Westgard multirules combine several observations to tell routine scatter apart from a real problem.

In practice, the 1_2s rule is used as a trigger to check the other, stricter rules — not as a rejection rule on its own. This layered approach keeps QC sensitive to real problems without constantly crying wolf over ordinary scatter.

Responding to an Out-of-Control Result

When a control result is rejected, the response is the same regardless of which rule fired.

1. Hold patient results. Nothing from the affected run is released until the cause is understood.
2. Look for an obvious cause first. Expired reagent, an air bubble, a maintenance step that was skipped, a new lot that wasn't verified, an environmental issue.
3. Repeat the control. If it passes and a clear, correctable cause was found and fixed, that is often enough to resume.
4. If it fails again, escalate. That may mean recalibrating, contacting the manufacturer, or pulling the instrument from service until resolved.
5. Only resume patient testing once QC passes. A repeat pass without an identified cause is a weaker resolution than one with a clear explanation, and some labs require the latter before reporting resumes.

Documentation & Regulatory Context

A QC corrective-action record is what turns "we fixed it" into something an inspector, auditor, or your own future self can verify.

What a complete record includes

• What was observed — which rule fired, which analyte, which level
• The investigation into root cause
• The corrective action taken
• Verification that QC passed afterward, before reporting resumed
• Who performed and who reviewed the correction

Governing frameworks

Several frameworks shape how labs are expected to run and document QC, including CLIA regulations in the U.S., CAP accreditation checklists, and the ISO 15189 standard internationally. Requirements differ in their specifics — minimum control levels, frequency, documentation retention — so the governing framework and the test's own SOP are always the authoritative source, not the general practice described in this manual.

Knowledge Check Question Bank

This chapter reproduces all ten questions from the course's scored knowledge check, along with the correct answer and explanation for each. It is intended for trainers and QA reviewers — not as a study sheet for learners in place of the course itself.