Safety reporting and tissue stewardship will tighten through 2027. Here are the updates lab leaders can act on now.
Also in this issue:
- Prepare for the 2027 unified safety reporting list
- Get ready for stricter CMS oversight of organ records
- Evaluate microtomy trimmings as a backup DNA source
- Set guardrails for patient-facing pathology visits
- Reduce HIPAA exposure as breach counts keep rising
Top Stories
One safety event list is coming in 2027
The Joint Commission and the National Quality Forum (NQF) plan to merge Sentinel Events and Serious Reportable Events into one framework starting January 1, 2027. The update also adds workforce safety measures alongside patient safety reporting.
Why this matters:
- Cuts duplicate reporting triggers across hospital and lab workflows
- Standard definitions can change root cause analysis and documentation expectations
- Links lab incident triage more tightly to enterprise risk programs
Key Takeaway: Use 2026 to align lab event triggers, evidence capture, and escalation paths with the unified 2027 list.
Action Step: Ask your quality and risk office for current system-wide event triggers. Compare them to lab incident categories, then map gaps and update training and escalation steps before 2027.
CMS targets tighter controls on organ documentation
The Centers for Medicare and Medicaid Services (CMS) proposed a rule to strengthen oversight of Organ Procurement Organizations (OPOs). It defines “unsound medical practices,” expands reportable adverse events, and adds documentation requirements for pancreata used in islet cell research.
Why this matters:
- Transplant teams may face stricter handoff documentation and tracking
- Broader adverse event definitions can drive more reviews and corrective actions
- Research-use organs may need clearer governance to meet audit expectations
Key Takeaway: Transplant-adjacent labs should expect more scrutiny on organ and tissue handling records, especially around exceptions and research use.
Action Step: If you support transplant or recovery teams, review how you document receipt, handling, and disposition. Confirm records capture who, what, when, where, and why at each handoff, plus any deviations.
A new molecular backup: save microtomy trimmings
A published commentary reports that pre-hematoxylin-eosin tissue trimmings, often discarded at microtomy, can yield DNA suitable for high-sensitivity molecular assays. The authors cite low contamination risk, with one sample reported at a 0.8% variant allele fraction.
Why this matters:
- Helps preserve diagnostic blocks when small biopsies need multiple downstream tests
- Creates a backup source when molecular needs expand after sign-out
- Needs validation for labeling, retention, and contamination controls
Key Takeaway: If you keep trimmings, treat it as a controlled specimen workflow, not an informal bench practice.
Action Step: Pilot a validation with histology and molecular leads. Define collection points, labeling rules, storage, and retention, the source mentions 6 months, then document contamination controls and confirmatory testing criteria.
🌶️ Provocative Take: Patient-pathologist visits, care win or liability trap?
A prospective study looked at clinics where transplant recipients meet with pathologists to review explanted organs and receive 3D-printed replicas. Patients reported better understanding and closure, but the visits are unreimbursed and need clear operational boundaries.
- Aligns with 21st Century Cures Act transparency expectations
- Adds documentation and liability questions outside standard lab workflows
- Sessions run 30 to 60 minutes, reducing time for sign-out and quality control
Key Takeaway: If you pilot patient-facing consults, set guardrails first: scope, consent, documentation, and time accounting.
A Prospective Video-Reflexive Ethnographic Study of Direct Patient-Pathologist Interactions • Study included 143 patient participants and reflected positive impacts on job satisfaction for 5 participating pathologists.
Quick Hits
Free CLIA training for lab directors
CDC and CMS launched Laboratory Director University, a free program focused on Clinical Laboratory Improvement Amendments (CLIA) compliance for laboratory directors and lab leaders.
HIPAA breach trend, recheck access controls
A HIPAA Journal report says U.S. data compromises rose 4% in 2025 versus 2024, a reminder to tighten access controls, monitor for data exfiltration, and speed incident response in HIPAA-regulated labs.
New GI multiplex PCR, vendor claims fast TAT
Cepheid reports Food and Drug Administration (FDA) clearance for its Xpert GI Panel for 11 pathogens, with about 74 minutes to results and under one minute hands-on time, based on vendor materials.
Galleri moves toward FDA review
Grail submitted its Galleri multi-cancer early detection test for Food and Drug Administration (FDA) premarket approval with data from 25,000 patients, which may affect future send-out strategy and patient expectations.
Reference intervals: altitude shifts NRBC baselines
A letter analyzing 77,396 specimens supports keeping nucleated red blood cells (NRBC) at 0.00 x 10^3/µL for a sea-level lab and flags altitude as a variable when verifying reference intervals.
Secure Your Tissue Samples
More oversight and more molecular demand put pressure on chain of custody and archive controls. If you are reviewing retention schedules or tightening specimen handling documentation, we can help you map gaps and next steps.
- Protect and enhance your lab’s traceability
- Expert guidance on specimen archival and retrieval
- Compliance-focused storage solutions