Tissue Transplantation Services: Coming into Compliance
Phillip J. DeChristopher, MD, PhD, ChairAnne Link, MT(ASCP), Tissue CoordinatorMeg Kim, RN, OR Manager
Committee Representatives from:• Russo Operating Room• Ambulatory Surgery Center• Oral Health• Center for Clinical Effectiveness• Clinical Laboratories• Hospital Administration• Materials Management• Patient Safety and Risk Management• Purchasing
Confidential: For Quality Improvement Purposes Only
Aim Aim Statement• Tissue Transplantation is a common practice in Loyola’s OR,
ASC, and Oral Health Center.
• In July 2005, the FDA and The Joint Commission (TJC) introduced new regulations and standards to ensure safe practices for tissue management.
• New systems were required to: Acquire, receive, store, and issue tissue Trace the use of tissue bi-directionally Investigate and follow-up on adverse events related to tissue
use and donor infections
• The goal of this project was to standardize processes for tissue management at Loyola to ensure compliance with federal regulations and TJC standards.
Confidential: For Quality Improvement Purposes Only
Project Measures of Success
To achieve a minimum of 90% compliance with the following measures:
Tissue Receipt• Package integrity and transport temperature are documented for incoming
tissue
Tissue Tracking• Tissues received are documented on the incoming tissue log
Tissue Storage• Daily temperatures for equipment and storage spaces are documented and
corrective action is taken when temperatures are out of range
Tissue Preparation• Materials used to prepare and/or process tissue are documented
Confidential: For Quality Improvement Purposes Only
The program manages over 70 different types of tissue products from 40 vendors.
Services that regularly use tissue include:
• Cardiovascular• Neurology• Ortho• Burns / Plastics• General Surgery• Ophthalmology• Oral Surgery
Confidential: For Quality Improvement Purposes Only
Solutions Implemented
• Formed a multi-disciplinary Tissue Services Committee • Created/hired a new position - Tissue Coordinator • Consolidated tissue storage in the main OR, ASC and Oral
Health • Replaced an OR freezer• Installed and validated an electronic, continuous-temperature
monitoring and alarm system • Developed and implemented a Tissue Services Policy Manual• Implemented standardized processes permitting traceability
and auditing of tissue transplanted, including ongoing reporting of incidents or non-conformances
Confidential: For Quality Improvement Purposes Only
Perc
ent C
om
plia
nce
Documentation of Package Integrity and Transport Temperature
0
20
40
60
80
100
120
UCL = 134.10
Mean = 91.55
LCL = 49.00
Prior to 2007: Data applies only to certain frozen boneJan 07- Present: Data applies to all tissue
Jan 07: All tissue is checked
July 07: Packing slips for 26 items were not scanned/saved
Confidential: For Quality Improvement Purposes Only
Perc
ent
Com
plia
nce
Log-In of Incoming Tissue
30
40
50
60
70
80
90
100
110UCL = 110.48
Mean = 88.50
LCL = 66.52
Prior to 2007: Data applies only to certain tissueJan 07-Present: Data applies to all tissue
Jan 07: All tissue is logged
Confidential: For Quality Improvement Purposes OnlyConfidential: For Quality Improvement Purposes Only
Confidential: For Quality Improvement Purposes Only
Perc
ent
Com
plia
nce
Documentation of Storage Device Temperature
85
90
95
100
UCL = 98.99
Mean = 93.95
LCL = 88.91
Prior to 2007: Data applies only to refrigerated and frozen tissue
Jan 07-Present: Data applies to all tissue
June 07: Implementation of the Rees Temperature Monitoring System
Jan 07: Began temperature monitoring for all tissue storage devices
Confidential: For Quality Improvement Purposes Only
Perc
ent
Com
plia
nce
Documentation of Tissue Preparation
65
70
75
80
85
90
95
100
105UCL = 105.67
Mean = 92.65
LCL = 79.63
Prior to 2007: Data applies only to autologous bone
Jan 07 – Present: Data applies to all tissue
Jan 07: Began monitoring for all tissue
Confidential: For Quality Improvement Purposes Only
Analysis & Outcomes
• The program has achieved a ≥ 90% target for all measures of success
• LUHS Tissue Services had a successful 2007 Joint Commission survey with no recommendations!
Confidential: For Quality Improvement Purposes Only
What’s Next? Next?
• Acquire a tissue tracking software system which will enable us to effectively and efficiently document, manage, track and trace our tissue inventory usage
• Continued oversight of tissue management by the Tissue Services Committee.
Thanks to all those involved in making our tissue program a success and in full compliance with
Joint Commission Standards!
Confidential: For Quality Improvement Purposes Only
Pulmonary Valve Allograft
Aortic Valve Allograft
Aortic and Mitral Valves – bovine or porcine source
Regenerative Tissue Matrix –
derived from human skin
Cornea
Tympanic Membrane