Tissue in TML: Is it a Match? Jim Vandevoorde BCSLS 2014

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1 Tissue in TML: Is it a Match? Jim Vandevoorde BCSLS 2014

2 What type of tissue? Bone Skin Tendon Amniotic membrane Pericardium Nerves Sclera

3 Cancellous bone

4

5 Tissue Matching? Are these matched to patients? Immune suppression?

6 Sentinel events Nov 2001 Cryolife Oct 2002 Pacific Northwest Feb 2003 BC Ear Bank Oct 2005 Biomedical Tissue Services (BTS) Aug 2006 Donor Referral Services (North Carolina)

7 Drivers for FHA Tissue Bank Sentinel events such as the February 2003 ear bank recall of dura matter, pericardium and bone; The publication of CSA standards (Z900.1, 2.2 and 2.4) for cells tissues and organs in June 2003; A gap analysis conducted by members of the department of Laboratory Medicine, in the fall of 2005, revealing a lack of Fraser Health compliance with the aforementioned standards and Health Canada directive and; Health Canada regulations enacted Dec 2007;

8 AABB - Guidelines for Managing Tissue Allografts in Hospitals 2006 The Joint Commission on Accreditation of Healthcare Organizations (JCAHO) recently established requirements for hospitals that receive, store, transplant, or distribute human tissue. Included is a crosswalk that links the JCAHO requirements with applicable AABB standards

9 AABB - Guidelines for Managing Tissue Allografts in Hospitals Foreword: A number of important events, including scrutiny by the FDA and JCAHO, have led to the now widely accepted idea that hospital tissue banks should be centralized Indeed, in many hospitals, the blood and transfusion service appeared to be the ideal location for centralization

10 Transfusion Editorial Transfusion 2007; 47: the only way to provide excellent tissue services in a way that mitigates legal, financial, and regulatory liability is to centralize tissue banks and/or tissue services under the auspices of the hospital transfusion services.

11 Why Transfusion Medicine? Tissue standards similar to TM standards Familiarity with regulatory environment & quality systems Knowledge of transfusion and transplant transmitted diseases Expertise in key functions of inventory management, monitored storage, record-keeping and tracking, issuing, recall management & adverse event reporting

12 Do blood banks want this? Transfusion 2007; 47: Web survey to 904 institutional members of whom 402 responded 81% used allogeneic/autologous tissue 76% stated that the OR/Surgery was responsible 72% thought there was a role for AABB

13 Overall Tissue Surgery Blood Infection Bank Control MSK 73% 38% 21% Eye 48% 17% 13% Skin 51% 26% 14%

14 OR oversight Advantages Readily available Porter service not required Easier selection of suitable grafts Disadvantages Ineffective traceability mechanism Freezers and fridges required at each facility Storage documentation inconsistent Open access Larger inventory required No mechanism for interhospital transfer

15 TML oversight Advantages Complete traceability mechanism Accredited storage protocols Experience with highly regulated products Better inventory control Centralized inventory 24 hour monitoring of storage 24 Hour availability for issuance Health Canada compliant Increase vigilance for graft safety Disadvantages Transport or porter services required Some delay for stat request at remote facilities

16 TML in key functions Inventory management Monitored storage Record-keeping and tracking, issuing Recall management & adverse event reporting Source establishment qualification

17 Traceability

18 Source Establishment qualification The many US-based suppliers and distributors of tissue make the selection of suppliers quite difficult. A process has been developed where we examine suppliers and distributors against the CSA standards and Health Canada regulations.

19

20 Recent May persons charged over alleged body parts theft

21 Fraser Health Gap Analysis 2005 Deficiencies in a number of areas, including: the lack of regional coordination, oversight and standardization of practices the need for a quality system framework the need for rigorous assessment of source establishments

22 Fraser Health Gap Analysis Given these deficiencies and to mitigate liability, Fraser Health executive have specifically asked Laboratory Medicine and Dr Doug Morrison to assume responsibility for this area and ensure compliance with Health Canada Regulations for Cells, Tissues and Organs.

23 Fraser Health Tissue Bank In July 2006 an outside consultant was hired to assist with the completion of this project A quality framework was established and a Tissue Coordinator was hired in July 2007

24 Fraser Health Tissue Bank Organization Tissue Advisory Committee (TAC) Tissue Bank Medical Director Tissue Bank Coordinator Assessment externally inspected for compliance by Health Canada at least every 3 years Internal audits performed for document control and staff competency Information Management Information on grafts and recipient is stored in the BBK Meditech module Custom reports have been built in Meditech for auditing

25 Fraser Health Tissue Bank The laboratory role: Receive and inspect tissue from the supplier, store according to established guidelines. Assign, issue and package tissue for transport to the Operating Room. Dispose and discard tissue in collaboration with the Pathology department.

26 Fraser Health Tissue Bank All tissue is received through either SMH or RCH TM laboratories.some tissue is stored and issued at smaller sites based on programs and usage. Packaging procedures are in place and validated shipping containers are used. Nursing staff at feeder hospitals receive the tissue directly in the Operating Room and must document transplantation or return of the tissue

27 Fraser Health Tissue Bank Autologous skin and bone (autografts) these tissues are entered into the laboratory information system and assigned a unique number for tracking purposes - ISBT. The laboratory staff will discard these tissue after the storage period expires (this varies from 2 weeks to 5 years and is dependant on type of tissue)

28 Fraser Health Tissue Bank Current practice at Fraser Health include: Bone flaps - stored in the RCH Tissue Bank Ossicles and skin - stored in the TM laboratory at the hospital sites that perform those specific procedures.

29 Fraser Health Tissue Bank Occurrence Management Clinical: Adverse Event reporting form completed by clinical staff and returned to TML & through to TC Reporting to source establishments as required by Health Canada

30 Fraser Health Tissue Bank Process (Continuous) Improvement Processes reviewed every 2 years (HC) and revised if required

31 Fraser Health Tissue Bank Training and Competency Training required for all lab and operating rooms staff handling tissue Frequent in-services for clinical staff on handling of tissues TML staff at RCH and SMH Validate new procedures Documentation required for HC inspection

32 Fraser Health Tissue Bank Document Format and Control All documents in the Fraser Health Tissue Manual are controlled documents Incorporated into TML manual Equipment Procedures for equipment maintenance part of TML manual TC assists with instrumentation requirements for some specialized transplant procedures TC assists in matching grafts as required

33 FH TB Recall and Lookback Recall and lookback processes follow the same process as blood donor unit recall and lookback. All recall and look back processes comply with Health Canada regulations.

34 Fraser Health Tissue Bank The laboratory has agreed to expand it s role with the addition of some Xenografts in our inventory. The goal was to manage the manage the regional inventory and screen for the approved indication as determined by surgical administration. This utilization strategy has reduced the number of grafts being stored throughout the region and has reduced the number of outdated grafts.

35 Fraser Health Tissue Bank Health Canada inspected compliant compliant

36 FH Tissue usage 2007/ / / / / / /2014 Amniotic Membrane Bone Fascia Lata Meniscus Nerve Osteochondrals Sclera Pericardium ADM - Skin Tendon Allograft total Xenograft Autologus tissue Total Tissue

37 Questions?

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