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

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