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

Tibia

Femoral Head

Achilles Tendon

Cervical Spacers

Injectable Bone Putty

Cancellous Bone Chips

Crushed Cancellous Bone

Pulmonary Valve Allograft

Aortic Valve Allograft

Aortic and Mitral Valves – bovine or porcine source

Regenerative Tissue Matrix –

derived from human skin

Cornea

Tympanic Membrane