What AAVLD Accreditation Requires From a Lab’s Data Systems

The American Association of Veterinary Laboratory Diagnosticians (AAVLD) holds accredited labs responsible for validating their LIMS and protecting the records inside it. AAVLD accreditation requirements, now published as document 1137 (formerly AC1), follow the applicable parts of ISO/IEC 17025 and name the LIMS in both the records and data sections.

Commercial software in general use can count as sufficiently validated under the standard. A LIMS is the exception.

Contents: Who is covered | Records management reqs | LIMS validation | Document control | 2021-01 changes | Questions for vendors | LabKey LIMS

What AAVLD accreditation covers

AAVLD accreditation is a voluntary evaluation of a lab’s quality management system by an outside reviewer. Reviewers look at the lab’s documented processes and quality controls.

The program accredits public veterinary diagnostic laboratories in North America. Public institutions such as state agencies and universities run the qualifying labs. Commercial laboratories aren’t eligible, and labs outside the program can pursue ISO/IEC 17025 accreditation through an independent body.

The National Animal Health Laboratory Network (NAHLN) sets a floor for the labs that join it. Its quality standards require Level 1 and Level 2 labs to hold AAVLD accreditation or ISO/IEC 17025 accreditation from an independent third party.

AAVLD records management requirements

The requirements call for a records management system with documented procedures for quality and technical records. Those procedures cover each stage of a record’s life:

• Identification and collection
• Indexing and access
• Storage and maintenance
• Disposal

Records must be accurate and contemporaneous. Each one traces to the person who made it and stays legible. Labs keep records secure and confidential. They also need procedures to back up computer records and block unauthorized access or changes.

Technical records hold enough detail to repeat a test under conditions as close as possible to the original, and they identify the personnel involved. When a record contains a mistake, the original stays visible and the correction is dated and attributed to the person who made it. Computer-collected data gets similar protection against loss or change of the original.

Retention follows the lab’s jurisdiction and its contractual obligations. Method validation data has a firmer rule: the lab keeps it for as long as the assay is in use and for at least 7 years after retirement.

AAVLD requirements for LIMS validation and data integrity

AAVLD expects test results and validation data to be secure and retrievable, and qualified personnel must approve them for use. Where computers or automated equipment handle that data, the lab needs procedures that protect integrity and confidentiality at entry, storage, transmission, and processing.

A lab validates its LIMS for functionality before introducing it, including the interfaces inside it. Any addition or removal of functionality needs authorization and documentation first, then software validation before implementation. Extensions to commercial off-the-shelf software fall under the same rule.

That obligation exists because the standard excludes a LIMS from the allowance that lets commercial software in general use count as sufficiently validated. A LIMS software that fails to operate as expected goes through the nonconforming work process. If an external provider hosts or maintains the system, the lab makes sure that provider meets the requirements that apply.

AAVLD document control requirements

AAVLD requires that only the current version of each document is in use and that staff have the documents they need at the work location. Authorized, qualified people review and approve changes. Every document carries a unique identifier and accurate cross-references.

The definition of a document is broad. It covers any instructions or information that affect test quality, from the quality manual to worksheets and forms.

What the 2021-01 revision added for LIMS

Version 2018-07 covered computer systems in general and never named a LIMS. The 2021-01 revision added rules written for one. A lab now has to:

• Validate the LIMS before introducing it, and validate functionality changes before they go live
• Protect LIMS records from unauthorized access and from tampering or loss
• Treat a LIMS failure as nonconforming work
• Make sure an outside provider meets the requirements if that provider hosts or maintains the system

The revision also took the LIMS out of the commercial-software allowance. A LIMS can no longer be treated as validated just because it’s in general use.

Note from editor: AAVLD renumbered the document from AC1 to 1137 in 2023, and its revision history lists no other change.

What to ask when evaluating a veterinary LIMS

A vendor’s answers show how much of the validation and record-protection work the system supports and how much your lab has to build itself. Validation and hosting deserve follow-up questions, because those obligations stay with your lab whichever vendor you choose.

Ask any vendor:

• Audit trail: Can you see who changed a record and when, with the original value preserved? (AAVLD 4.10.2.3)
• Access control and tamper protection: Can you restrict who views and edits records by role? (AAVLD 4.10.2.4, 5.4.4.4)
• Backup and hosting: Who runs backups, and if the vendor hosts the system, how do you confirm it meets the requirements that apply to you? (AAVLD 4.10.1.4, 5.4.4.6)
• Validation support: What documentation helps you validate functionality and interfaces before go-live, and what happens when a release changes functionality? (AAVLD 5.4.4.3.2)
• Specimen identification and report versions: Does a specimen’s ID persist from receipt through the final report? Can an amended report reference the original and record the reason for the change? (AAVLD 5.8.2, 5.10.9, 5.10.10)
• Controlled documents: Where do SOPs and test methods live, and how are revisions approved? Document control applies whether that happens in the LIMS or in a separate system. (AAVLD 4.3)

Raise hosting arrangements and document control with your quality manager early in an evaluation.

LabKey LIMS and AAVLD requirements

LabKey Veterinary LIMS keeps an audit history of system activity. When a row changes, the log records what changed, and administrators can require users to enter a reason for actions such as editing or deleting samples. Each sample has a timeline showing registration, updates, storage changes, chain of custody and check-ins and check-outs. Permission roles control who can view and edit, and role assignments appear in the audit log.

For validation, LabKey offers software validation as an add-on for Sample Manager Professional and LabKey LIMS. LabKey validates three major releases a year, so you get new functionality while maintaining your validation status.