TJC audit pack — generated automatically
Upload your biomedical register. Struktive normalises every record and produces a seven-tab TJC EC.02.04.01 audit workbook with SHA-256 tamper-evident hash, PHIPA/HIPAA data handling fields, and chain of custody — in under five minutes.
Every framework your HTM team is accountable to
Pre-populated exports for accreditation, privacy, asset management, and device regulation.
The compliance problems Struktive solves
Two days before every TJC survey
Biomedical engineers spend 40+ hours manually cleaning device inventory before each Joint Commission survey. Struktive does it in minutes — and produces the audit pack automatically.
No tamper-evident chain of custody
Regulators increasingly ask for proof that the data hasn't been altered between collection and submission. A SHA-256 hash on every export provides that proof without additional tooling.
PHIPA / HIPAA data handling gaps
Most biomedical registers don't flag which devices handle ePHI or are network-connected. Struktive adds these fields automatically based on device category and model, closing the gap before an audit.
Seven-tab workbook, generated on every run
Every normalisation run produces a complete audit workbook. No manual assembly, no copy-paste, no version control issues.
Sign-off block with SHA-256 tamper-evident hash and authorised signatory space. Hospital name, date, job ID, Struktive version, device count, and quality score summary.
Overall data quality score. Devices by category (Imaging, Life Support, etc.). Key findings: top 5 issues by frequency, duplicate count, records below quality threshold (<60). Recommendations.
Full normalised device register with all fields. Colour-coded quality score column (green ≥80, amber 60–79, red <60). Frozen header row. Filter-ready. FDA UDI and criticality columns included.
Pre-populated TJC Environment of Care checklist. Device counts by category, Life Support devices flagged, maintenance schedule status, and location hierarchy for each device.
Every data quality flag with field name, raw value, normalised value, and recommended action. Filterable by severity (Critical / Warning / Info). Exportable for remediation tracking.
Full audit trail: upload timestamp, file hash, processing steps, field-level changes, operator ID, and export timestamp. Tamper-evident. Defensible in regulatory review.
Data handling attestation: ePHI flag per device, network-connected status, data residency confirmation, and processing log for privacy officer sign-off.
Environment of Care — pre-populated
The TJC EC.02.04.01 standard requires hospitals to maintain an accurate inventory of all medical equipment subject to a maintenance management programme. Struktive generates the checklist automatically.
Counts by GMDN device category: Imaging, Life Support, Patient Monitoring, Surgical, Infusion, Lab, Biomedical Accessories, Facilities, IT & Clinical.
All Life Support devices flagged Critical with a dedicated column. Ventilators, defibrillators, infusion pumps, and anaesthetic machines highlighted for surveyor review.
Campus → building → floor → ward → unit → bed-space for every device. TJC surveyors can locate any device in the building without additional lookup.
PM due date and last service date columns pre-populated from your register. Overdue maintenance flagged in amber for immediate attention.
PHIPA & HIPAA data handling fields — automatic
Struktive adds ePHI handling flag and network-connected status to every device record based on category and model. No manual data entry. Privacy officers get a pre-populated attestation sheet ready for sign-off.
- ePHI handling flag: auto-assigned to Patient Monitoring, Imaging, and IT & Clinical devices
- Network-connected status: flagged for all devices with known network-connected models
- Data residency confirmation: processing location logged for cross-border compliance
- Privacy officer sign-off block: pre-formatted for PHIPA and HIPAA attestation