Implant Management:
The Importance of Tracking
and Tracing All Implants, with
a Focus on Human Tissue
Robert Martin,
Clinical Supply Chain Manager
Christiana Care Health System
Wilmington, DE
Jonell Gibson,
Implant Control Supervisor
Christiana Care Health System
Wilmington, DE
Christiana Care Health System is one of the
country’s largest health care providers.
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Serves more than 600,000 patients a year
Placed 16th in leading hospitals in the nation
Placed 10th on the East Coast for number of admissions
CCHS is made up of two hospitals
1,100 licensed beds
Performs 40,000 surgeries annually
Surgical Materials Distribution
Surgical Materials Distribution has 7.5
Implant Auditors to manage 12 million
dollars in implants.
• Owned inventory = 3.3 million
• Consigned inventory = 8.7 million
Tissue Inventory
Tissue Inventory
$1,316,163.30
Non-Tissue Inventory
$10,683,836.70
Opportunity for Improvement
There was a “Black Market” tissue scandal that made headlines in
2005.
 Tissue was illegally obtained by a NJ company and sold to
tissue processing companies
The Joint Commission issued standards for tracking and tracing
human tissue.
 Hospital must use standardized procedures to acquire, receive,
store and distribute tissue.
 Hospital’s record keeping permits the traceability of all tissue
from the donor or source facility to all recipients or other final
disposition.
 Hospital has a defined process to investigate adverse events to
tissue or donor infections.
Opportunity for Improvement
We performed a gap analysis of our current tissue processes
with the assistance of industry experts. The analysis revealed
the following concerns:
 Verification of FDA registration and AATB (American
Association of Tissue Banks) certification not on file
 Receipt process did not include temperature verification and
inspection for package integrity
 No tracking/monitoring of tissue movement to and from
OR’s
 Storage not centralized
 Disposition of tissue not well documented
Opportunity for Improvement
Measurable Goals
 100% of tissue will be tracked and traced
from receipt to disposition (implanted,
wasted or returned to supplier)
 100% of tissue implanted will be traced to
the patient
 Maintain appropriate par levels for tissue
 The amount of expired tissue will be
decreased by 80% by July 2009
Action Plan:
Beginning Solutions
• Limited the receipt of all tissue to Implant Auditors to
include the inspection of all packages to ensure that the
integrity of product was maintained during the
transportation process
• Implemented an INet based system to track and trace
tissue
• Revised policies to include updated procedures
• Implemented the monitoring of temperatures of all
freezers and refrigerators
• Began the investigation of available tissue tracking
systems
Action Plan:
Implementation of Tissue Tracking System
April 2008 – Implemented Tissue Tracking Software
• Performed an inventory of all tissue
Amount of Tissue on Hand
Freezer
Refrigerator
Room Temp
TOTAL
Chr OR
98
44
457
599
Wilm OR
26
22
45
93
Wilm
Surgi
0
6
32
38
TOTAL
124
72
534
730
Average Monthly Usage
May-07
June-07
Chr OR
175
178
Wilm OR
8
11
Wilm
Surgi
11
11
TOTAL
194
200
Action Plan:
Implementation of Tissue Tracking System
April 2008 – Implemented Tissue Tracking Software
• Centrally located all tissue to one storage area
• All tissue was entered into tissue database
• Education was provided to Perioperative Staff
regarding how to obtain tissue
• Educated all end-users
• Implemented a tissue customer service line
• Purchased Bar Code Scanners to enter tissue
information into database
Action Plan:
Implementation of Tissue Tracking System
We utilized the test region for three
days to ensure system integrity and
end user accuracy.
We went live on
April 17th, 2008!!
Process for
Tracking Tissue
To properly track tissue, it should be
centrally located and secured
Implant Storage Room
at Christiana OR –
contains all tissue and
implants
Badge access is
required to gain
entry into the
Implant Room.
Within the secured
location all tissue
should be contained
within locked
cabinets.
When OR staff need tissue a call
is placed to the designated
tissue extension.
The Implant Auditor will pull the
requested tissue. This eliminates
the wait time and provides the OR
Staff with optimal service.
The tissue bar code is scanned and it is moved within database.
Patient
Information
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Nuvasive
Osteocel 5cc
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When tissue is
implanted or
wasted, it is
documented
on an
Implant Record by
OR Staff.
After the Implant Auditor receives the Implant
Record the information is entered into the
database. The implant process begins by
entering the patients MRN number.
The information regarding the patient
and procedure is entered.
The tissue bar code is scanned.
We must document the
final disposition of
the tissue.
We need to verify that all information
is correct.
This is the confirmation screen stating
that the tissue has been implanted.
After hours, OR staff call the Charge Nurse for
assistance when tissue is needed.
Once the tissue is selected the OR Staff will access
the CCHS INet and fill out the
Tissue Retrieval Form.
All unused tissue is returned to the
Implant Room by the Charge Nurse .
Once tissue is secured, the
OR Staff will fill out the
Tissue Return Form
Once the I-Net form is submitted it is sent to
the Tissue Tracking Implant Auditor
via email. All information is
transferred into tissue database.
RESULTS
Clinical Excellence:
All tissue is tracked from receipt
to final disposition
Clinical Excellence:
Recalls
With the tissue tracking
software recalls are easier
and extremely accurate.
We are notified about recalls through
a paid third party.
Recall notification can also
be communicated by the
vendor or from a letter
from the company.
After receiving the recall information, it is entered
into the tissue tracking database.
Basic recall information is then
entered into the system.
All tissue impacted by recall is
entered into the database by
using the tissue identifiers.l
A confirmation screen
identifies all patients impacted
by the recall and locates all
defective product remaining
in inventory.
Clinical Excellence:
Patient Safety
Patients are assured that all tissue
used at CCHS is safe for use!!
• All tissue is purchased from an FDA
registered and AATB certified vendor
• All tissue is inspected and monitored from
receipt to final disposition.
• All tissue is tracked for adverse events
Clinical Excellence:
Improved Customer Service
• Implant Auditor accessible by phone
• Call ahead of time to have tissue pulled
• Improved inventory management which
results in zero stock-outs
Improved Inventory Management:
• Vendors have controlled access to inventory.
This restricts the unauthorized delivery or
removal of inventory.
• Inventory counts are available in “real time”.
 This allows for accurate management of
inventory at all sites.
 This also allowed us to reduce our inventory
on hand.
• We have greatly reduced the amount of tissue
that expires through improved reporting
capabilities.
Tracking
Non-Biological
Implants
In addition to tracking tissue,
we track all other implants.
To effectively track
implants, they must
be in a central
location with
controlled access.
The Process for Tracking Implants
• A daily upload from the OR Scheduling Software to
Excel provides the following:
 Patient Name
 Doctor
 Case Number
 Operating Room Number
• The following information is added to the spreadsheet
to allow for tracking purposes:
 Employee Badge
 Implant & Quantity Taken
 Time Out
 Implant & Quantity Returned
 Time In
The Process for Tracking Implants
 When OR staff need an implant,
their badge is scanned with the
implant to the specific OR room
and patient
 If the implant is used it is
documented on the Implant
Record
 If the implant is not used it is
returned and scanned back into
the Implant Room
The Process for Tracking Implants
The next day:
 The Implant Auditor compares all
Implant Records to the tracking
spreadsheet to account for all implants
 Discrepancies are reconciled with the
Perioperative staff member
responsible for the implant
Improved Inventory Management:
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No Satellite Inventory Locations
No Shrinkage
Facilitates Cycle Counts
Disciplined Utilization
Reduction of Inventory
• Obsolete
• Consolidation of par locations
• Standardization via consolidation of like product
• Eliminates losses due to expired product
• Product can be transferred intra-facility or returned
to vendor
• Assists in reconciliation of charges vs purchases
Questions