Transcript Slide 1
Bridging the Gap
Between Biologics &
Compliance
Grant Funds Provided by
Continuing Nursing Education Credit
Provided by
Objectives
Define biologics
Describe the regulations & standards
related to biologics
Discuss problem prone areas associated
with tissue management in the OR setting
Discuss best practices for tissue
management
Defining Biologics
Autograft
Allograft
Xenograft
Synthetics
Recombinant Human Growth Factors
Bioengineered Grafts – biologic tissue that is
combined with synthetic material for implantation
Regulations and Standards
U.S. Food & Drug Administration
Center for Biologics and Research (CBER)
- Requirements for human tissue banks (HCT/Ps)
◦ HCT/Ps are Human Cellular and Tissue Based-Products
- Must register w/ the FDA (2001)
- Requirements for donor suitability
- Must follow the Good Tissue Practices (2005)
◦ Rules for record keeping
◦ Authority for FDA to inspect tissue banks
◦ Ability to recall or destroy tissue
Medical Devices…..510(k), PMA
American Association of Tissue
Banks (AATB)
Voluntary accreditation of human tissue
banks
Three areas of accreditation
- Retrieval
- Processing
- Storage/Distribution
www.aatb.org
The Joint Commission (TJC)
Transplant Safety
Voluntary accreditation of hospitals and ASCs
Apply to human and nonhuman cellular based
transplantable & implantable products
- Tissues (allograft & autograft)
- Medical devices (allograft & xenograft)
Three areas of focus:
- Standardized procedures to acquire, store, and issue
tissue
- Tissue tracking
- Investigating adverse events
AORN: Recommended Practices for
Surgical Tissue Banking
Guidelines for utilization of human tissue in the
surgical setting
Recommendations for establishing an optimal
level of practice as it relates to allograft tissue
Synthesized recommendations of FDA, AATB
and The Joint Commission
American Association of Blood
Banks (AABB)
Created to assist hospitals in the transition
toward centralizing tissue banks and
services within blood banks and
transfusion centers in the hospital
Utilizes TJC standards as a guide
Problem Areas in Tissue
Management
Receipt
Storage
Tissue Handling
Other
Receipt
Date & time
Tissue description
Tissue serial number
Expiration date
Verification
- Recommended temp
- Integrity of package
- Bar code/serial
numbers are accurate
Personnel receiving
and verifying tissue
JC Standards: Transplant Safety TS.03.01.01, EP 6,7
JC Standards: Transplant Safety TS.03.02.01 EP 3
Receipt
Is the temperature acceptable?
- Residual Coolant
◦ e.g. dry/wet ice
Validated shipping container
- Documentation from supplier
- Within validated timeframe
Package Integrity
- Seal intact
- No physical damage
- Labels/barcodes are present
Vendors
Distributors of tissue must register annually with
the FDA
Some states require licensure
TJC requires healthcare facilities to verify
registration & licensure
Reps carrying allograft into the OR may be a
violation of this requirement
- Documentation of registration
- Documentation of receipt of tissue
Storage
Monitoring and recording
Automated delivery
Freezer maintenance
Monitoring & Recording
Requirements
Maintain daily storage logs for freeze-dried
tissues requiring a controlled environment
Continuously monitor the temperature of
freezers & refrigerators
- Record at least daily
Ensure that all storage equipment has
functioning alarms
- Alarm to area manned 24/7
•JC Standards: Transplant Safety (TS.03.01.01, TS.03.02.01, TS.03.03.01)
•AORN Recommended Practices for Surgical TB. AORN Journal, February 2006.
•AABB Guidelines for Managing Tissue Allografts in Hospitals
Handling
Check graft & package
- Integrity
- Expiration date
Use aseptic technique
Follow instructions on
package insert
Handling
Who handled?
- Dates, times & staff
How prepared?
- Per manufacturer’s instructions
- Save instructions
Solutions used?
- Lot # and expiration
Include in patient’s medical record
- Tissue type, unique identifiers
Return tissue tracking forms to allograft
tissue bank
Record Keeping
All records must be stored for minimum of ten
years, but may be longer in your state,
including:
– Tissue supplier
– Original numeric or alpha-numeric donor and
lot identifiers
– Recipient name or the final disposition of
each tissue
– The expiration dates of all tissues
All tissue usage information cards are
completed and returned to the tissue supplier
•JC Standards: Transplant Safety (revised TS.03.02.01)
•AORN Recommended Practices for Surgical TB. AORN Journal, February 2006.
Transporting Between
Facilities
FDA registration as a tissue bank is imperative
to distribute tissue to another facility
Exceptions
- Facilities that are physically adjacent within
the same healthcare organization
Recalls & Adverse Events
Must be able to trace the tissue
- From the donor to the recipient
- From the recipient to the donor
Report adverse events to supplier and possibly
FDA
The Joint Commission requires a policy
For more information:
- FDA Current Good Tissue Practices, 2005
- AABB Guidelines for Managing Tissue Allografts in
Hospitals, 2006
- Steelman & Schlueter (2007). Managing a tissue
recall in a large academic hospital. Transfusion.
47(5):927-34.
Top Three Concerns: TJC
1. Verification of tissue source facilities
- FDA registration & state licensure
2. Verification of package upon receipt
- Documentation required
3. Temperature recording & monitoring
- Recording daily for ambient and refrigerated
tissue
- Continuous temperature monitoring for
freezers & refrigerators
◦ Continuous recording is not required
Algorithm for Tissue
Management
Define responsibility
Develop a team
Identify all biologics used
Map the process, “Standardize”
Review the requirements
Create a policy
Bridging the Gap
Every Joint Commission accredited facility
MUST have a tissue policy
Goal is to standardize tissue management within
all areas of the facility
Test by tracking serial numbers / patient
implants
Adverse Events
Documentation is the most important piece of
this process
Tissue Tracking Options
Manual data capture and recording
- Hand written paper forms
- Excel Spreadsheets
- Forms from tissue bank
Automated data capture in automated system
- Data transfer or bar coding
- Tracking and data storage in automated
platform
Manual Paper Tracking
Inconsistent staff participation
Hand written data can be difficult to track
- Legibility
- Searching for old data
- Conducting a tissue recall (6 mo. vs. 2 min.)
Stickers or barcode labels can improve accuracy
- May fall off manual sheets
Multiple staff involvement
Backing up data
Errors
The “Ideal” Tracking Option
Integrates with
existing health
information
system
Utilizes
barcodes,
scanners, RFID
tracking
Tracks allograft,
autograft and
non-tissue items
Traces product
through final
disposition
Prompts for
expiring tissue
and performs
inventory
reconciliation
Does not burden
hospital IT
department
Automatically
completes tissue
usage forms
Adverse event
and recall
tracking system
Automated Tracking
Real-time
Web-based, automated
Manage and track tissue receipt,
transfer, issuance, validation,
implantation or disposal
Monitor every person that interacts with
the tissue
Most systems allow hospital-specific
customization and real-time access from
any location within the facility
Automated Tracking: Time
Savings
May allow self-population
of data with a barcode
scan
Implantation data
transferred electronically to
the tissue supplier
Instant identification of all
tissue inventory by serial
number, code, or type
Automated Tracking: Cost
Savings
May prevent the use of expired tissue
through a notification system
Ordering process is streamlined with
the facility-established inventory levels
Labor hours are significantly reduced
with automated tracking versus paper
tools
Assist with rotation of inventory and
notifications for inventory that is about
to expire
Automated Tracking:
Compliance
Automatic tracking from purchasing through
implantation
Reports are simplified and customized
Recalls conducted efficiently and completely
Ideal tracking systems will update their platform
as The Joint Commission and FDA requirements
change
Any Questions?
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