Test Overview
Test name, methodology, analytes measured, clinical utility, and applicable CPT code.
4.8
on G2
Free Healthcare Template
Testing procedure for [assay/test] with specimen requirements and QC protocols
Use this template to testing procedure for [assay/test] with specimen requirements and QC protocols.
| Field | Details |
|---|---|
| Category | Healthcare |
| Owner | [Team or owner] |
| Version | [Version number] |
| Effective Date | [Date] |
| Review Cycle | [Monthly / Quarterly / Annual / Event-based] |
| Status | [Draft / In Review / Approved] |
Test name, methodology, analytes measured, clinical utility, and applicable CPT code.
| Item | Details | Owner | Status |
|---|---|---|---|
| [Item or requirement] | [Describe the relevant detail, evidence, or decision] | [Owner] | [Open / Complete] |
| [Item or requirement] | [Describe the relevant detail, evidence, or decision] | [Owner] | [Open / Complete] |
[Add context, assumptions, exceptions, evidence links, screenshots, calculations, or reviewer comments.]
Specimen type, collection container, minimum volume, patient preparation, transport conditions, stability, and rejection criteria.
| Item | Details | Owner | Status |
|---|---|---|---|
| [Item or requirement] | [Describe the relevant detail, evidence, or decision] | [Owner] | [Open / Complete] |
| [Item or requirement] | [Describe the relevant detail, evidence, or decision] | [Owner] | [Open / Complete] |
[Add context, assumptions, exceptions, evidence links, screenshots, calculations, or reviewer comments.]
List all analyzers, reagents, calibrators, and controls with catalog/part numbers and storage requirements.
| Item | Details | Owner | Status |
|---|---|---|---|
| [Item or requirement] | [Describe the relevant detail, evidence, or decision] | [Owner] | [Open / Complete] |
| [Item or requirement] | [Describe the relevant detail, evidence, or decision] | [Owner] | [Open / Complete] |
[Add context, assumptions, exceptions, evidence links, screenshots, calculations, or reviewer comments.]
Calibration frequency and materials, QC levels (normal and abnormal), acceptable ranges, corrective actions for out-of-range QC.
| Item | Details | Owner | Status |
|---|---|---|---|
| [Item or requirement] | [Describe the relevant detail, evidence, or decision] | [Owner] | [Open / Complete] |
| [Item or requirement] | [Describe the relevant detail, evidence, or decision] | [Owner] | [Open / Complete] |
[Add context, assumptions, exceptions, evidence links, screenshots, calculations, or reviewer comments.]
Detailed numbered steps from specimen receipt through result verification. Include instrument operation, dilution protocols, and manual steps.
| Item | Details | Owner | Status |
|---|---|---|---|
| [Item or requirement] | [Describe the relevant detail, evidence, or decision] | [Owner] | [Open / Complete] |
| [Item or requirement] | [Describe the relevant detail, evidence, or decision] | [Owner] | [Open / Complete] |
[Add context, assumptions, exceptions, evidence links, screenshots, calculations, or reviewer comments.]
Age and sex-stratified reference ranges in a table. Note critical/panic values and required notifications.
| Item | Details | Owner | Status |
|---|---|---|---|
| [Item or requirement] | [Describe the relevant detail, evidence, or decision] | [Owner] | [Open / Complete] |
| [Item or requirement] | [Describe the relevant detail, evidence, or decision] | [Owner] | [Open / Complete] |
[Add context, assumptions, exceptions, evidence links, screenshots, calculations, or reviewer comments.]
Clinical interpretation guidance, interfering substances, and limitations of the method.
| Item | Details | Owner | Status |
|---|---|---|---|
| [Item or requirement] | [Describe the relevant detail, evidence, or decision] | [Owner] | [Open / Complete] |
| [Item or requirement] | [Describe the relevant detail, evidence, or decision] | [Owner] | [Open / Complete] |
[Add context, assumptions, exceptions, evidence links, screenshots, calculations, or reviewer comments.]
Common analytical issues with corrective actions. Use tables for specimen requirements, reference ranges, and QC criteria.
| Item | Details | Owner | Status |
|---|---|---|---|
| [Item or requirement] | [Describe the relevant detail, evidence, or decision] | [Owner] | [Open / Complete] |
| [Item or requirement] | [Describe the relevant detail, evidence, or decision] | [Owner] | [Open / Complete] |
[Add context, assumptions, exceptions, evidence links, screenshots, calculations, or reviewer comments.]
Document review conclusions, approvals, unresolved items, and next review date.
| Role | Name | Date | Notes |
|---|---|---|---|
| Preparer | [Name] | [Date] | [Notes] |
| Reviewer | [Name] | [Date] | [Notes] |
| Approver | [Name] | [Date] | [Notes] |
Template Structure
Use this healthcare template as a starting point, then customize each section to match your internal workflow, evidence, and signoff needs.
Test name, methodology, analytes measured, clinical utility, and applicable CPT code.
Specimen type, collection container, minimum volume, patient preparation, transport conditions, stability, and rejection criteria.
List all analyzers, reagents, calibrators, and controls with catalog/part numbers and storage requirements.
Calibration frequency and materials, QC levels (normal and abnormal), acceptable ranges, corrective actions for out-of-range QC.
Detailed numbered steps from specimen receipt through result verification. Include instrument operation, dilution protocols, and manual steps.
Age and sex-stratified reference ranges in a table. Note critical/panic values and required notifications.
Clinical interpretation guidance, interfering substances, and limitations of the method.
Common analytical issues with corrective actions. Use tables for specimen requirements, reference ranges, and QC criteria.
Write a Laboratory Test Procedure following CLSI (Clinical and Laboratory Standards Institute) document format. Use precise technical language. Structure with these sections:
Test name, methodology, analytes measured, clinical utility, and applicable CPT code.
Specimen type, collection container, minimum volume, patient preparation, transport conditions, stability, and rejection criteria.
List all analyzers, reagents, calibrators, and controls with catalog/part numbers and storage requirements.
Calibration frequency and materials, QC levels (normal and abnormal), acceptable ranges, corrective actions for out-of-range QC.
Detailed numbered steps from specimen receipt through result verification. Include instrument operation, dilution protocols, and manual steps.
Age and sex-stratified reference ranges in a table. Note critical/panic values and required notifications.
Clinical interpretation guidance, interfering substances, and limitations of the method.
Common analytical issues with corrective actions.
Use tables for specimen requirements, reference ranges, and QC criteria.
SOP ID: LAB-HEM-2026-001 | Effective: 2026-02-01 | Analyzer: Sysmex XN-1000 Department: Hematology | CLIA Complexity: Moderate | CPT: 85025
The Complete Blood Count (CBC) with automated differential is performed on the Sysmex XN-1000 hematology analyzer using fluorescence flow cytometry and impedance methods. It quantifies WBC, RBC, hemoglobin, hematocrit, platelet count, and automated 5-part WBC differential. The CBC is the most commonly ordered laboratory test, used for screening, diagnosis, and monitoring of hematologic and systemic conditions.
| Parameter | Requirement |
|---|---|
| Specimen type | Whole blood |
| Container | EDTA (lavender top), K2EDTA preferred |
| Minimum volume | 1.0 mL (pediatric: 0.5 mL in microtainer) |
| Patient preparation | None required |
| Transport | Room temperature; analyze within 4 hours of collection |
| Stability | 24 hours at room temp for CBC; 8 hours for differential |
| Rejection criteria | Clotted specimen, hemolyzed, incorrect tube, unlabeled, QNS |
| Material | Level | Frequency | Acceptable Range |
|---|---|---|---|
| Sysmex e-CHECK (XN) | Low | Each 8-hour shift | Mean ± 2 SD |
| Sysmex e-CHECK (XN) | Normal | Each 8-hour shift | Mean ± 2 SD |
| Sysmex e-CHECK (XN) | High | Each 8-hour shift | Mean ± 2 SD |
| Calibrator (S-CAL) | Single level | Every 6 months or after major maintenance | Manufacturer target ± tolerance |
Out-of-range QC: Do not report patient results. Repeat QC with fresh aliquot. If still out of range: check reagents, run maintenance, recalibrate if needed. Document corrective actions.
| Analyte | Adult Male | Adult Female | Critical Low | Critical High |
|---|---|---|---|---|
| WBC | 4.5 - 11.0 x10³/uL | 4.5 - 11.0 x10³/uL | < 2.0 | > 30.0 |
| RBC | 4.5 - 5.9 x10⁶/uL | 4.0 - 5.2 x10⁶/uL | < 2.0 | > 7.0 |
| Hemoglobin | 13.5 - 17.5 g/dL | 12.0 - 16.0 g/dL | < 7.0 | > 20.0 |
| Hematocrit | 38.3 - 48.6% | 35.5 - 44.9% | < 20% | > 60% |
| Platelets | 150 - 400 x10³/uL | 150 - 400 x10³/uL | < 50 | > 1000 |
CRITICAL VALUE PROTOCOL: Immediately notify ordering provider for any critical value. Document provider name, time notified, and read-back confirmation. Maximum 30 minutes from result verification to provider notification.
| Issue | Probable Cause | Corrective Action |
|---|---|---|
| High WBC with blast flags | Abnormal cells present | Prepare smear for manual differential |
| Platelet clump flag | EDTA-induced aggregation | Redraw in sodium citrate tube; multiply count by 1.1 |
| Hemolysis interference | Traumatic draw or transport | Request recollection; note on report if clinically urgent |
| QC drift on Hgb | Aging reagent or lamp degradation | Replace reagents; run optical check; recalibrate |
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Template FAQ
Common questions about using and generating a lab Test Procedure.
Q: What is a lab Test Procedure?
A: A lab Test Procedure is a structured document for testing procedure for [assay/test] with specimen requirements and qc protocols.
Q: Can I download this lab Test Procedure as Word or PDF?
A: Yes. This page includes free downloads in DOCX, PDF, and Markdown formats so you can edit, share, or import the template into your documentation system.
Q: Can Docsie generate this from a video?
A: Yes. Upload a process walkthrough, training recording, or screen capture to Docsie, then use this template structure to generate a first draft automatically.