LabQMHub Editorial Team · ISO 15189:2022 Quality Management Series
A laboratory information system sits at the center of virtually every process this training program covers — orders, results, quality control data, and reports all pass through it, often invisibly, hundreds or thousands of times a day. When it works well, it is easy to forget it is even there; when it fails or corrupts data silently, the consequences can touch every patient the laboratory serves simultaneously.
ISO 15189:2022’s Clause 7.6 requires laboratories to manage information systems with the same rigor applied to any other critical laboratory process: validated before use, protected against unauthorized access, and backed by a genuine contingency plan for when systems fail.
Why Information System Control Deserves Dedicated Attention
Unlike a single miscalibrated instrument, which typically affects one test on one analyzer, an information system error can silently affect every result passing through it — a mistaken unit conversion, a corrupted reference range table, or a flawed interface mapping between an analyzer and the reporting system can generate widespread, hard-to-detect errors across many patients simultaneously.
This scale of potential impact is precisely why ISO 15189:2022 treats information system management as a distinct, dedicated requirement rather than an incidental IT concern — the stakes of getting this wrong are proportionally larger than almost any single instrument failure.
Validation Before Deployment
Before a new information system, or a significant update to an existing one, goes live, it must be validated to confirm it performs as intended — correctly transmitting results, applying reference ranges accurately, and flagging critical values appropriately — under conditions that mirror actual laboratory use, not just vendor-supplied test scenarios that may not reflect the laboratory’s specific configuration.
This validation connects directly to the method verification and validation principles covered earlier in this program: just as a new test method must be proven to perform correctly before clinical use, so must the system responsible for transmitting and reporting the results of that method.
Responsibilities, Authorities, and Access Control
Clear responsibilities and authorities for the information system — who can modify reference ranges, who can access which categories of patient data, who approves system changes — must be defined and enforced through role-based access control, connecting directly to the confidentiality principles covered early in this program.
Audit trails that record who accessed or modified data, and when, provide the traceability needed to investigate a data integrity concern after the fact, and their existence and integrity should themselves be periodically verified rather than assumed to be functioning correctly.
System Downtime and Contingency Planning
Information systems will, eventually, fail or require planned downtime, and a laboratory without a rehearsed downtime procedure risks reverting to ad hoc, error-prone manual processes exactly when clear thinking matters most. ISO 15189:2022 expects a documented downtime procedure covering manual result recording, critical value notification without system support, and the process for reconciling manual records back into the system once it is restored.
This connects directly to the continuity and emergency preparedness planning covered later in this program — an information system outage is one of the most common and disruptive scenarios a laboratory’s continuity plan must specifically address, given how central these systems have become to nearly every laboratory function.
Frequently Asked Questions
Why does a laboratory information system need to be validated like a test method?
Because errors in the system — incorrect unit conversions, flawed interface mapping, wrong reference ranges — can affect the accuracy or delivery of results just as significantly as an analytical error, often across many patients at once.
What should a laboratory downtime procedure include?
Manual result recording methods, a process for critical value notification without system support, and a clear procedure for reconciling manual records into the system once it is restored.
Who should have access to modify laboratory reference ranges in the information system?
Only specifically authorized personnel, controlled through role-based access, with changes captured in an audit trail that is periodically verified for integrity.
Key Takeaways
- Information system errors can silently affect results across many patients simultaneously, unlike most single-instrument failures.
- New systems or significant updates must be validated under conditions mirroring actual laboratory use before going live.
- Role-based access control and clear responsibilities protect data confidentiality and integrity, enforced by periodically verified audit trails.
- A documented, rehearsed downtime procedure prevents reversion to error-prone improvisation during system outages.
- Reconciling manual records back into the system after downtime requires a clear, defined process to avoid data gaps or duplication.
- Information system continuity is a critical component of the laboratory’s broader emergency preparedness planning.
Conclusion
The laboratory information system has become as central to safe, accurate testing as any analyzer on the bench, yet its central, largely invisible role can make it easy to under-invest in its formal quality control. ISO 15189:2022 corrects this by demanding the same rigor applied everywhere else in the laboratory.
Laboratories that validate their systems thoroughly, control access carefully, and rehearse downtime procedures protect not just data, but every patient whose care depends on that data being accurate and available when needed.
Learn how laboratories handle complaints and customer feedback in the next course of this ISO 15189:2022 training series.
Source note: this article draws on “Quality Management in Clinical Laboratory Demystified” by Dr. Taleb Chalab Cham, ISO 15189:2022, and widely recognized clinical laboratory quality references including CLSI guidelines, CAP accreditation checklists, and WHO laboratory quality guidance.
