bridging the gap between biologics & compliance. grant funds provided by continuing nursing...
TRANSCRIPT
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
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
U.S. Food & Drug Administration
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
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
AORN: Recommended Practices for Surgical Tissue Banking
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 6,7JC 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: TJC1. Verification of tissue source facilities
- FDA registration & state licensure 2. Verification of package upon receipt
- Documentation required3. 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
Does not burden hospital IT department
Utilizes barcodes, scanners, RFID tracking
Integrates with existing health information system
Prompts for expiring tissue and performs inventory reconciliation
Tracks allograft, autograft and non-tissue items Traces product
through final disposition
Adverse event and recall tracking system
Automatically completes tissue usage forms
The “Ideal” Tracking Option
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?
Evaluation / Registration
Please remember…
Complete your registration and evaluation forms in the back of your booklet
Return them to your presenter