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TissueQA supporting both clinical and research eligibility review
An organization running clinical tissue processing alongside a biologics and research program needed TissueQA to handle two distinct eligibility frameworks, with a QA review stage before the medical director.
The context
Organizations that operate both clinical tissue processing and research or biologics programs carry two distinct eligibility frameworks inside the same institution. Clinical release requires meeting donor eligibility standards that trace to the organization's own SOPs. Research and biologics programs have their own criteria, sometimes more permissive on clinical eligibility thresholds, sometimes more specific about tissue characteristics, always documented separately from clinical SOPs.
For this organization, the QA review stage sits at the intersection of both. QA reviewers confirm that a donor case has been evaluated correctly before it moves to the medical director. In practice, this means cross-checking that all required fields are present, all flags have been addressed, and the case record is complete enough to support a recorded decision, clinical or research.
This engagement explored two things: whether TissueQA could be configured for this organization's musculoskeletal and biologics-derived tissue types with their specific eligibility SOPs, and how the QA review stage could be supported by a structured pre-summary rather than a raw document review.
What we configured
The organization's clinical and research eligibility criteria required separate SOP mapping. A case going to clinical release and a case being evaluated for research or biologics use would surface different fields, different matching rules, and different PARTIAL flag thresholds.
Separate SOP mapping was built for clinical tissue processing criteria and biologics/research criteria, reflecting the fact that the same donor record may be evaluated against different standards depending on intended use. Extraction field sets were tuned to musculoskeletal and biologics-derived tissue, with fields relevant to processing requirements specific to this organization's methods.
PARTIAL flag configuration was aligned to the QA review stage: the flags QA reviewers need to resolve before escalating to the medical director, separated from flags that require MD acknowledgment directly. Citation links connect every finding to the specific SOP clause and donor record page it comes from, supporting QA reviewers who need to verify source accuracy. Reviewer override capture was configured at both the QA stage and the MD stage, recording each qualified human decision separately.
Capabilities deployed
- TissueQA SOP mapping across clinical and research/biologics eligibility criteria as separate configurations
- Extraction fields tuned to musculoskeletal tissue and biologics-derived tissue processing requirements
- PARTIAL flag surfacing at the QA review stage with QA-specific escalation thresholds
- Citation links to donor record source pages and SOP clauses at the field level
- QA reviewer sign-off capture before the case reaches the medical director
- Medical director sign-off screen with AI summary, source citations, and electronic signature
- Audit trail recording the QA review decision and the MD decision as separate qualified human actions
What the workflow now supports
QA reviewers receive a structured summary before opening the full donor record. Every field the summary contains is cited. Gaps that need resolution before the case can move to the MD are surfaced explicitly. When a QA reviewer resolves a partial flag or overrides a finding, that decision is captured in the record alongside the AI output that prompted it.
At the MD stage, the medical director sees the case after QA has already worked through it, with the QA review decision recorded, and makes the final eligibility determination with the cited summary and the QA record both visible.
The configuration distinguishes between clinical and research use cases at the SOP level. The same underlying donor record can be evaluated against two different criteria sets, with each producing a separate cited output and a separate recorded decision.
Talk to our team
Tell us about your donor screening workflow.
30 minutes, no slides. Bring your SOPs, your stack, and the stage that hurts most. We will tell you honestly whether DonorIQ is the right fit.