TJC PC.17.10 Tissue Storage and Issuance
Tissue products used in surgical procedures represent valuable and critical resources that must be preserved with precision and care. The Joint Commission Standard PC.17.10 establishes comprehensive requirements for tissue storage, handling, and issuance in accredited healthcare facilities. These requirements protect the viability and safety of tissue products while ensuring complete traceability throughout the storage and use cycle.
Why Tissue Storage Matters
Tissue products, including allograft bone, cartilage, skin, heart valves, and other biological materials, are sensitive to temperature fluctuations and environmental conditions. Improper storage compromises tissue viability, rendering expensive products unusable and potentially delaying necessary surgical procedures. Additionally, tissue products are fully traceable biological materials—facilities must maintain detailed records connecting specific tissues to specific patients for quality assurance and potential recall purposes.
Proper tissue storage ensures:
- Patient Safety: Guarantees tissue viability and integrity for successful surgical implantation
- Surgical Outcomes: Ensures tissue properties are preserved for optimal graft integration
- Resource Protection: Prevents waste of expensive tissue inventory through proper environmental control
- Regulatory Compliance: Maintains Joint Commission accreditation and state licensing requirements
- Traceability: Supports tissue tracking from procurement through implantation
TJC PC.17.10 Requirements
Continuous Temperature Monitoring
The first and foundational requirement of PC.17.10 is continuous temperature monitoring of all tissue storage equipment. This includes:
- 24/7 Monitoring: Automatic temperature recording at regular intervals (typically every 5-15 minutes)
- Digital Data Loggers: Electronic devices that continuously track and record storage unit temperatures
- Alarm Integration: Monitoring systems must have built-in alarm capabilities that trigger when temperatures deviate from acceptable ranges
- Real-Time Alerts: System must immediately notify responsible personnel of any temperature deviations
Alarm System Requirements
All tissue storage equipment must have functional alarm systems with multiple alert mechanisms:
Audible Alarms: Loud audible signals triggered by temperature excursions, equipment failures, or power loss that alert nearby staff immediately.
Visual Alarms: Light indicators or display messages that provide backup notification and remain visible even in noisy environments.
System Coverage: Alarms must cover high temperature deviations, low temperature deviations, equipment failures, power failures, and door ajar conditions.
Testing: All alarm systems must be tested regularly to ensure proper function and staff familiarity with alert types.
Emergency Backup Power
Tissue storage equipment must remain operational during facility power outages:
- Battery Backup: For monitoring devices and alarm systems
- Generator Backup: For tissue storage equipment itself
- Alternative Arrangements: Emergency contacts for portable tissue storage if primary systems fail
- Testing Schedule: Regular testing of backup systems to ensure functionality
- Response Protocols: Written procedures for staff response during power disruptions
Daily Temperature Documentation
Each tissue storage unit requires daily temperature verification and documentation:
- At Least Once Daily: Manual temperature check and recording
- Multiple Daily Checks: Many facilities implement checks at beginning and end of business day
- Documentation: Records must be maintained in permanent facility files
- Verification: Documented evidence that checks were actually performed by responsible personnel
- Comparison to Digital Records: Manual checks should align with continuous monitoring data
Storage Per Manufacturer Specifications
Each tissue product type has specific storage requirements that must be followed precisely:
- Temperature Ranges: Tissue-specific temperatures (e.g., 1-6°C for fresh tissues, -80°C or -196°C for cryopreserved)
- Humidity Requirements: Some tissues require specific humidity levels
- Storage Containers: Manufacturer-specified containers to prevent contamination and desiccation
- Labeling Requirements: Proper identification with tissue type, source, processing date, expiration date
- Separation: Tissues stored in organization minimizing cross-contamination risks
10-Year Record Retention
PC.17.10 requires comprehensive record retention for 10 years minimum from tissue issuance:
Records to Maintain:
- Temperature monitoring records (daily checks and digital logs)
- Tissue transfer logs (showing movement between storage units)
- Staff training and authorization records
- Incident reports for any temperature excursions
- Equipment maintenance and calibration records
- Tissue inventory audits and reconciliation
- Tissue disposition records (when tissues are used or discarded)
Retention Format: Records must be preserved in permanent, retrievable format suitable for regulatory inspection.
How ATEK Supports PC.17.10 Compliance
ATEK’s environmental monitoring platform is designed to help healthcare facilities meet all PC.17.10 tissue storage requirements through automated monitoring, intelligent alerting, and comprehensive documentation.
Continuous Monitoring and Alert Response
ATEK monitors all tissue storage equipment 24/7 with:
- Real-time temperature logging at configurable intervals
- Immediate multi-channel alerts via email, SMS, and mobile app
- Detailed incident documentation when deviations occur
- Integration with facility emergency response procedures
Automated Daily Documentation
ATEK automatically generates daily temperature verification reports:
- Professional documentation ready for regulatory inspection
- Timestamp verification proving actual monitoring occurred
- Comparison of manual checks to automated monitoring data
- Exception-based reporting highlighting any deviations
10-Year Record Management
ATEK maintains complete tissue storage records:
- Cloud archive automatically retaining all data for 10+ years
- Secure backup ensuring no data loss
- Compliance-ready export in multiple formats (PDF, CSV, Excel)
- Audit trails showing all system access and modifications
Emergency Response Support
When temperature excursions occur, ATEK provides:
- Immediate incident alert and documentation
- Complete timeline showing deviation start, peak, and resolution
- Automatic report generation supporting emergency response decisions
- Integration with facility incident management protocols
Best Practices for PC.17.10 Compliance
Daily Operations
- Perform visual inspection of all tissue storage equipment each morning
- Check and record storage temperatures at consistent times daily
- Verify that monitoring system is functioning and displaying current data
- Review any alerts or notifications immediately
- Document any equipment issues or concerns in facility log
Weekly Activities
- Verify backup power systems are operational and charged
- Confirm all tissues are properly labeled with identification information
- Perform inventory count to verify no missing or misplaced tissues
- Review temperature monitoring charts for any concerning trends
- Test alarm systems to ensure audible and visual alerts function
Monthly and Quarterly
- Clean and decontaminate storage equipment according to manufacturer guidelines
- Verify calibration status of all monitoring thermometers
- Audit tissue inventory records against physical count
- Review and update tissue storage and emergency procedures as needed
- Document all maintenance and testing activities
Annual Requirements
- Conduct comprehensive facility compliance audit
- Refresh all staff training and authorization certifications
- Perform full calibration and functional testing of all monitoring equipment
- Review and verify continuing compliance with manufacturer specifications
- Document complete compliance status for regulatory files
Regulatory Context
The Joint Commission is the primary accrediting organization for U.S. hospitals and many surgical centers and transplant programs. PC.17.10 compliance is a fundamental requirement for maintaining accreditation. State regulations often incorporate or reference Joint Commission standards, adding additional enforcement authority. Failure to maintain PC.17.10 compliance can result in:
- Loss of accreditation and licensing
- Regulatory enforcement action by state health departments
- Inability to procure or use tissue products
- Patient safety incidents and legal liability
- Delayed surgical procedures due to unavailable tissue
ATEK’s comprehensive monitoring and documentation platform helps organizations maintain continuous PC.17.10 compliance while protecting patient safety and surgical outcomes.