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
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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
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Receipt
Storage
Tissue Handling
Other
Receipt
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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
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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
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