At StaffReady, we write about many issues organizations can have during laboratory inspections. Often, the lack of compliance is because of omission: policies or procedures that are not fully documented or are not always followed. However, this isn’t always the most pervasive issue; sometimes organizations face citations because their procedures or policies are not wrong but outdated.

Even if a policy or procedure is correct, use of an outdated version can cause numerous complications and ramifications, such as a failed inspection or fines. Some can also directly impact patient safety and test results.

Why Version Control Matters in Compliance

Regulatory bodies like CLIA, CAP, and The Joint Commission expect labs to have a robust document management system. During audits or inspections, it’s not uncommon for surveyors to ask:

• “Where is the latest version of this procedure stored?”
• “Who approved the last update and when?”
• “How do you ensure staff aren’t using an outdated version?”

A missing approval date or uncontrolled SOP in use on the bench can raise red flags, delay inspections, and in some cases, lead to fines or citations. Beyond inspection readiness, version confusion can result in procedural mistakes, particularly in critical workflows like specimen processing, equipment calibration, or medication compounding.

Common Pitfalls in Laboratory Document Control

Even well-organized labs can fall into version control traps. Some of the most common issues include:

• Multiple storage locations: SOPs saved in a shared drive, printed binders, local desktops, and email threads
• Unclear update procedures: No designated owner for reviewing or revising SOPs on a schedule
• Lack of archival: Old versions not being archived or labeled clearly, increasing the risk of unintentional use
• Open access: Anyone can change or distribute SOPs without oversight or a revision log, leading to multiple versions in circulation
• Poor communication: Staff aren’t notified when SOPs are updated, or they don’t know where to find them

These oversights don’t just jeopardize compliance; they also damage trust, increase liability, and create operational inefficiencies.

Best Practices and Recommendations for Managing SOP Versions

To meet both regulatory standards and practical operational needs, you should consider adopting a formal version control system that includes:

• Centralized Document Repository: Store all SOPs, policies, and forms in a single, accessible, and permission-controlled system. Cloud-based platforms or document control software can simplify this.
• Automated Version Tracking Every update should generate or include a new version number, track the author or editor, record the approval date, and maintain a change history.
• Approval Workflows: Define a clear process for reviews and approvals before any new version becomes active. Include sign-offs from relevant stakeholders (e.g., lab director, QA, department head).
• Automatically Triggered Notifications: Notify affected staff whenever a document is updated. Include summaries of changes and any required retraining.
• Audit Trail:s Maintain digital records of who accessed what and when, which can be presented during inspections.
• Archiving and Retention Policies: Retain prior versions with clear “obsolete” labels. Never delete old SOPs without a formal review and documentation process.

If you’d like to learn more about how StaffReady can accelerate your operations and help you address these issues using our clinical workforce management tools, you can book a meeting with one of our experts here.