Human Tissue
Liability, Patient Safety
and Regulatory Compliance
DUKE KASPRISIN, M. D.
Chief Medical/Scientific Officer
Biomedical Synergies, Inc.
DAVID A. BUCZEK, M.A.
President
DB&A Inc.
SAFMLS – 26 February 2007
© Biomedical Synergies, DB&A Inc., 2007
1
&
DB A
Agenda
• Tissue Related Adverse Outcomes
• Overview of Tissue Banking
• Prevention of Disease Transmission Via
Transplantation
• JCAHO and AABB Standards
• Case Study Activity
• Appropriate Holistic Response Approach
• Getting Started
SAFMLS – 26 February 2007
© Biomedical Synergies, DB&A Inc., 2007
2
&
DB A
Duke Kasprisin, M.D.
BSI Chief Medical Officer
• Board certified physician, and nationally recognized
authority in all aspects of tissue transplantation
• Immediate Past President and current Board Member,
American Association of Tissue Banks (AATB)
• Editor, Standards for Tissue Banking for AATB
• Member, CDC/FDA Organ and Tissue Safety Workshop
• Member, AATB Sentinel Committee on Tissue
Associated Infections
• Member, American Association of Blood Banks (AABB)
Tissue Working Group on JCAHO compliance for
member blood banks
• 25 years experience with the American Red Cross,
including 10 years as Chief Medical Officer for
Transplantation Services
SAFMLS – 26 February 2007
© Biomedical Synergies, DB&A Inc., 2007
3
&
DB A
Four charged in a plan to sell
body parts for medical use In New York, a Grisly Traffic in Body Parts
Illegal Sales Worry Dead's Kin, Tissue
Recipients - Washington Post
TV host Alistair Cooke's bones allegedly stolen;
Thieves sold venerable broadcaster's body parts for
$7,000, report says - MSNBC
Hospital asks judge to dismiss lawsuits over cadaver tissue
BLOOMINGTON, Ind. -- Bloomington Hospital has asked a judge to
dismiss lawsuits filed by patients who received tissue from human
cadavers during surgery, saying the issue first should go before a state
medical review panel.- Chicago Tribune
Tainted Bone Scandal - (Ft Wayne, IN)- Last week, four
people were charged with stealing body parts from corpses
and selling those parts to distributors.
- NewsChannel 15 (Ft. Wayne, IN)
SAFMLS – 26 February 2007
© Biomedical Synergies, DB&A Inc., 2007
4
&
DB A
Prevention Of Disease Transmission
Via Transplantation
•
•
•
•
•
•
•
Donor History Screening
Donor Physical Exam
Donor Blood Tests
Issues concerning cadaveric samples
Autopsy
Tissue Processing Steps
Compatibility
SAFMLS – 26 February 2007
© Biomedical Synergies, DB&A Inc., 2007
5
&
DB A
Case Study
• In 2004, a young male patient presented in the
emergency room with nausea, vomiting, and
difficulty swallowing.
• His mental status began to deteriorate and a
subarachnoid hemorrhage was found on
computerized tomography.
• His condition continued to worsen and he died
four days later.
• He subsequently donated kidneys, lungs, and
liver and these organs were transplanted into
four patients.
SAFMLS – 26 February 2007
© Biomedical Synergies, DB&A Inc., 2007
6
&
DB A
Case Study
• The patient receiving the lung transplant died of
intraoperative complications.
• The three other organ recipients had successful
surgeries and were discharged from the
hospital.
• However, all three began to experience
progressive neurologic problems and died within
four to five weeks following the transplants.
• Laboratory investigations of the three recipients
revealed they died of rabies. During later
investigations it was revealed that the donor had
been bitten by a bat.
SAFMLS – 26 February 2007
© Biomedical Synergies, DB&A Inc., 2007
7
&
DB A
Case Study
• A fourth patient at the same transplant center
who had not received an organ from this donor
developed similar symptoms following a liver
transplant.
• On autopsy it was discovered that this patient
also died of rabies.
• There was no evidence of cross contamination
of this patient and no additional cases of
encephalitis consistent with rabies found at the
hospital.
SAFMLS – 26 February 2007
© Biomedical Synergies, DB&A Inc., 2007
8
&
DB A
Case Study
Why did the fourth patient develop rabies?
SAFMLS – 26 February 2007
© Biomedical Synergies, DB&A Inc., 2007
9
&
DB A
Case Study
• During the subsequent investigation it was
discovered that the iliac arteries from the
infected donor were not used during the liver
transplant.
• They were placed in a sterile container and
stored for later use.
• The vessel was used in another liver transplant
patient who then died of rabies.
• Because of inadequate labeling it couldn’t be
proven that the vessel absolutely came from the
same donor.
SAFMLS – 26 February 2007
© Biomedical Synergies, DB&A Inc., 2007
10
&
DB A
HIV From Bone & Tendon Allografts
• Case from unprocessed femoral head (live
donor) prior to anti-HIV testing. Donor was IV
drug user (MMWR 1988;37:587)
• Cases from anti-HIV Neg organ & tissue donor
(donors in window period) (NEJM 1992;326:726)
– Transmitted by unprocessed frozen tendon, two
unprocessed frozen femoral heads,
– Not transmitted by freeze-dried tendon(cells removed
from bone ends, antibiotic soaked), freeze-dried
bone(cells removed, ETOH soak) and irradiated dura
SAFMLS – 26 February 2007
© Biomedical Synergies, DB&A Inc., 2007
11
&
DB A
HCV From Bone & Tendon Allografts
• From frozen femoral head prior to antiHCV test available
• Cases from 1990 anti-HCV 1.0 Neg
donor(retrospectively Pos with anti-HCV
2.0) JBJS 1995; 77-A:214
– Transmitted by frozen, unprocessed tendon & bone
– Not transmitted by freeze-dried irradiated bone
SAFMLS – 26 February 2007
© Biomedical Synergies, DB&A Inc., 2007
12
&
DB A
Infectious Risks in Tissue
Transplantation
Window Period for Infection Before and After
Anti-HIV
HBsAg
Anti-HCV
NAT
22 days
59 days
70 days
Plus NAT
7 days
20 days
7 days
Zou, et al. N Engl J Med 2004; 351:751-759
SAFMLS – 26 February 2007
© Biomedical Synergies, DB&A Inc., 2007
13
&
DB A
Infectious Risks in Tissue
Transplantation
Probability of a Viremic Tissue Donor
Before and After NAT
HIV
HBV
HCV
Current
1/55,000
1/34,000
1/42,000
SAFMLS – 26 February 2007
Post-NAT
1/173,000
1/100,000
1/421,000
© Biomedical Synergies, DB&A Inc., 2007
14
&
DB A
Allograft Associated Bacterial Infections
- Clostridia
• Nov 7, 2001. 23 Yr Old Male, St. Cloud, Minn. Knee
Surgery Using Refrigerated “Fresh” Femoral Condyle.
– Nov 10, Knee Pain, Then Severe Hypotension
– Nov 11, Died. Postmortem Blood Culture: Clostridium sordelli
• Nov 13, 2002. 17 Yr Old Male (Illinois) Knee Surgery
Using “Fresh” Femoral Condyle and Meniscus
– Nov 14. Fever, Unresponsive to Cephalosporin Antibiotic
– Day 8. Readmitted to Hospital. Septic Arthritis, Temp 103.5 F
(39.7 C). Treated With Ampicillin, Sulbactam. Improved.
– No Culture Done For Anaerobic Bacteria (For Clostridium )
• 3 Allografts. Same Tissue Bank, Same Donor.
CDC - Jernigan, Kainer, MMWR- 2002;51(Mar 15):207-10
SAFMLS – 26 February 2007
© Biomedical Synergies, DB&A Inc., 2007
15
&
DB A
C. Sordelli Infection Investigation
• Tissue Processed After Body Stored Room Temp 19 Hrs
Plus 4 Hrs Refrigerated
• 19 Unused Tissue From Same Donor
– 2 Grew C. sordelli (Fresh Fem. Condyle, Frozen Meniscus)
– Fluid Bathing Allografts Grew C. sordelli
• 10 Tissue Transplanted Into 9 Other Patients, 8 States
– No Additional Infections Reported
• Tissue Bank Processing
– Aseptic. No Disinfectant. No Sterilant
– Antibiotic Soak
– Companion Tissue (Cartilage) Cultured After Antibiotic Exposure No Growth
– No Other Final Sterility Tests
– No Preprocessing Cultures
MMWR 2002;51(Mar 15):207-10
SAFMLS – 26 February 2007
© Biomedical Synergies, DB&A Inc., 2007
16
&
DB A
Clostridium Sepsis
• Tissue Processing Facility
– Does Not Use Bacterial Testing of Tissues Prior to
Processing (e.g. at Procurement)
– Aseptic Processing, No Terminal Sterilization
– Antibiotic Soaks Used and May Have Interfered With
Detecting Clostridium
– No Bacteriostasis Testing
– Processing Not Validated to Ensure Sterility
• FDA Stopped Further Tissue Processing and
Distribution
SAFMLS – 26 February 2007
© Biomedical Synergies, DB&A Inc., 2007
17
&
DB A
Allograft Associated Bacterial Infections
CDC
• CDC Solicited Other Cases of Surgical Site
Infection Within 12 Months of Transplant
• 26 Reports (Include 4 Tendon and 2 Femoral
Condyles Previously Reported)
– 13 (50%) Clostridium Infection (C sordelli-1, C.
septicum-12)
– 11 of 13 Infections Involved Allograft From Same
Tissue Processor
MMWR 2002;51(Mar 15):207-10
SAFMLS – 26 February 2007
© Biomedical Synergies, DB&A Inc., 2007
18
&
DB A
Invasive Streptococcus
• Healthy 17 yr old male
• Elective, anterior cruciate
ligament repair
(September)
• Hemi-patellar ligament
allograft used
• Symptoms developed 1
day post-op
– Pain, erythema at incision
– Febrile (39°C)
– Chills
SAFMLS – 26 February 2007
© Biomedical Synergies, DB&A Inc., 2007
19
&
DB A
Recipient Outcome
• Re-admitted 6 days postop and allograft removed;
fasciotomy of affected
thigh performed
• Blood, wound aspirate,
and explanted allograft all
grew same organism
• Identified as Strep.
pyogenes (group A
streptococcus - GAS)
• Treated and improved
SAFMLS – 26 February 2007
Photo from http://www.clinicalmicrostat.com/index.html
Example of blood agar plate w/GAS growth: beta hemolysis
(complete lysis of red cells), bacitracin susceptibility (zone
of inhibition around impregnated disk)
© Biomedical Synergies, DB&A Inc., 2007
20
&
DB A
Processor A
• Received assorted tendons, patellar ligaments,
meniscus, and vascular tissues from donor
– Pre-processing cultures performed on 14 tissues
• Positive for growth - GAS identified on each tissue
– These allografts were aseptically processed by
treatment with antimicrobial soaks
– All final, post-processing cultures were negative
SAFMLS – 26 February 2007
© Biomedical Synergies, DB&A Inc., 2007
21
&
DB A
Investigation - Processor A
• Four tendons and one ligament from same
donor were implanted in patients
– No adverse outcomes reported from these surgeries
– Remaining allografts from this donor were recalled or
quarantined from distributable inventory
• All were cultured and GAS was not cultured from any
– Temporarily suspended distribution of all similar
allografts
SAFMLS – 26 February 2007
© Biomedical Synergies, DB&A Inc., 2007
22
&
DB A
Processor B
• Received musculoskeletal and soft tissues
from same donor
• Donor deferred due to travel history in UK
– Exclusionary criterion for processor B
– All cultures (swab cultures obtained at
recovery) grew GAS - these results would
have also disqualified donor for this bank
SAFMLS – 26 February 2007
© Biomedical Synergies, DB&A Inc., 2007
23
&
DB A
Donor Information
• Previously healthy male
in his 30s
• Had cervical spine fusion
for degenerative disc
disease 3 weeks prior to
death
• 3 days before death,
presented to an ER
w/diffuse rash (thought to
be medication reaction)
Example of cervical DGD (arrows).
This is an example only, not case patient’s.
SAFMLS – 26 February 2007
© Biomedical Synergies, DB&A Inc., 2007
Photo from http://brighamrad.harvard.edu/Cases/bwh/hcache/119/step-1.html
24
&
DB A
Investigation - CDC
• GAS isolated from unprocessed fascia lata
(Processor B) and from archived blood
specimen (Processor A)
• Special stains showed GAS in the skin,
blood vessels, and lung of donor
• Emm gene typing proved same organism
in donor and recipient
SAFMLS – 26 February 2007
© Biomedical Synergies, DB&A Inc., 2007
25
&
DB A
Diseases Transmitted By Tissue
Transplantation
Bone
Bacteria
Hepatitis
HCV
TB
HIV
Tendon
Bacteria
HIV
HCV
Cartilage
Bacteria
Cornea
Bacteria
Hepatitis B
Rabies
CJD
Yeast
Skin
Bacteria
HIV
? CMV
Heart Valve
Bacteria
? TB
Yeast
? Hepatitis
Pericardium
Bacteria
? CJD
Dura
CJD
SAFMLS – 26 February 2007
© Biomedical Synergies, DB&A Inc., 2007
26
&
DB A
How often do major adverse outcomes
happen?
• We don’t have surveillance systems than
can define the true incidence
• Many some cases probably go undetected
• Organs: approximately 20,000 per year –
15 cases from 2002-2005 or 0.02%
• Tissues: approximately 900,000
transplants per year and 19 cases from
2003-2005 or 0.0004% - excluding bone
products the number is at least 10x higher
SAFMLS – 26 February 2007
© Biomedical Synergies, DB&A Inc., 2007
27
&
DB A
Overview of Tissue Banking
Tissues Available
•
•
•
•
•
Skin
Bone
Tendon
Fascia
Heart valves
SAFMLS – 26 February 2007
•
•
•
•
Blood vessels
Pericardium
Corneas
Cellular components
(e.g. chondrocytes)
• Reproductive tissues
© Biomedical Synergies, DB&A Inc., 2007
28
&
DB A
Overview of Tissue Banking
Decisions in choosing what tissue to use
• Purpose of the surgery
• Risks of the product
• Specifications of the
tissue
• Alternatives engineered
vs. non-engineered
• Instrumentation
• Cost
• Physician preferences
SAFMLS – 26 February 2007
© Biomedical Synergies, DB&A Inc., 2007
29
&
DB A
Overview of Tissue Banking
Types of tissues available and their uses
• Spinal surgery
• Non-engineered
• Bone needs to be cut and
shaped in OR
Unicortical ilium block
SAFMLS – 26 February 2007
Tricortical ilium block
Bicortical ilium block
© Biomedical Synergies, DB&A Inc., 2007
30
&
DB A
Overview of Tissue Banking
Types of tissues available and their uses
• Spinal surgery
• Engineered
SAFMLS – 26 February 2007
© Biomedical Synergies, DB&A Inc., 2007
31
&
DB A
Overview of Tissue Banking
Types of tissues available and their uses
• Demineralized bone matrix – Used as a bone
void filler
SAFMLS – 26 February 2007
© Biomedical Synergies, DB&A Inc., 2007
32
&
DB A
Prevention Of Disease Transmission
Via Transplantation
• Processing
– In surgery cases where donor was in the
window period for HCV or HIV, those
receiving unprocessed tissues or organs
developed infections, while those receiving
processed tissue did not
SAFMLS – 26 February 2007
© Biomedical Synergies, DB&A Inc., 2007
33
&
DB A
Prevention Of Disease Transmission
Via Transplantation
•
Processing
– Tissue Processing Steps:
1.
2.
3.
4.
5.
6.
7.
8.
Cleaning, dilution
Antibiotics
Biocleanse®
AlloWash®
Clearant Process®
Radiation – dose issues
Alcohol
Ethylene oxide
– Limitations in transplants other than bone
SAFMLS – 26 February 2007
© Biomedical Synergies, DB&A Inc., 2007
34
&
DB A
The Joint Commission (formerly JCAHO)
created tissue standards for hospitals
effective 7/01/05
• Evaluates and accredits more than 15,000
health care organizations and programs in the
United States
• Independent, not-for-profit organization
• Nation's predominant standards-setting and
accrediting body in health care
• Mission: To continuously improve the safety and
quality of care provided to the public through the
provision of health care accreditation and related
services that support performance improvement
in health care organizations
SAFMLS – 26 February 2007
© Biomedical Synergies, DB&A Inc., 2007
35
&
DB A
QC.5.300 (PC 17.10)
• An organizational unit must be assigned
that will be responsible for all steps
involved in the utilization of tissue
– Question: Who in a hospital is best suited to
oversee this process? (lab or surgery)
•
•
•
•
Validation of equipment
Monitoring temperatures for storage
Answer storage unit alarms during all shifts
Tracking recipients
SAFMLS – 26 February 2007
© Biomedical Synergies, DB&A Inc., 2007
36
&
DB A
Who Controls Tissues in Hospitals?
• In a study by the CDC surgical departments had
responsibility for tissue use (76%) followed by
the blood bank (51%).
• In some hospitals blood bank managed certain
tissues while surgery handled others. Usually in
those hospitals where surgery had responsibility
this did not include stem cells.
• Infection control departments were most
commonly the responsible party for adverse
reaction reporting.
SAFMLS – 26 February 2007
© Biomedical Synergies, DB&A Inc., 2007
37
&
DB A
Advantages of Assigning Tissue
Management to the Laboratory
• Blood Bank has the appropriate education and
training to validate equipment and processes
and monitor compliance with the procedures
• Present 24/7 to monitor refrigerated and frozen
products
• Greatest knowledge of quality assurance
• Most experience with tracking and tracing
human products and managing recalls
SAFMLS – 26 February 2007
© Biomedical Synergies, DB&A Inc., 2007
38
&
DB A
Disadvantages of Assigning Tissue
Management to the Laboratory
• Blood Bank already overtaxed. Will additional
resources be allocated to manage the
complexity of tissue
• Does not have intricate knowledge of tissue
banking
• Can Blood bank be given authority to oversee
training, monitor products, reconstitution and
use in the OR
• Will the Blood Bank get cooperation to manage
investigations if there is an adverse reaction
SAFMLS – 26 February 2007
© Biomedical Synergies, DB&A Inc., 2007
39
&
DB A
Organizational Design to Meet
Joint Commission Standards
Musculoskeletal
tissue
Orthopedic
unit
Skin
Cardiovascular
tissue
Reproductive
tissue
Burn unit
Surgical
Specialty
units
Fertility clinic
Autologous ?
SAFMLS – 26 February 2007
Look Familiar?
© Biomedical Synergies, DB&A Inc., 2007
40
&
DB A
Organizational Design to Meet The
Joint Commission Standards
Musculoskeletal
tissue
Autologous
Skin
Cardiovascular
tissue
Centralized Control
And monitoring
SAFMLS – 26 February 2007
© Biomedical Synergies, DB&A Inc., 2007
Reproductive
tissue
41
&
DB A
QC.5.300 (PC 17.10)
Vendor validation
• Single or multiple points of entry into
hospital
– Blood (red cells, plasma, platelets, albumin,
clotting factors, etc.) Blood bank/pharmacy
– Tissue (bone, tendons, reproductive cells,
stem cells, skin, vessels, corneas, heart
valves, etc.) Surgery or surgical specialty
units, reproductive clinics, blood bank, others
SAFMLS – 26 February 2007
© Biomedical Synergies, DB&A Inc., 2007
42
&
DB A
QC.5.300 (PC 17.10)
Vendor validation
• Identify all significant criteria for suppliers
– AATB accredited?
– How tissue is processed
– Availability of hard to obtain products
– Price
– Timing of shipments
– If using tissue distributor:
• how do they store products?
• Are they FDA registered?
SAFMLS – 26 February 2007
© Biomedical Synergies, DB&A Inc., 2007
43
&
DB A
QC.5.300 (PC 17.10)
Vendor validation
• Question: Are all suppliers registered with
the FDA?
– Obtain documentation of FDA registration
from source facility and/or FDA web site:
https://www.accessdata.fda.gov/scripts/cber/C
FAppsPub/tiss/index.cfm
– Document state licensure if applicable
– Ensure that FDA registration validation is
applicable and available for each tissue type
from source facilities
SAFMLS – 26 February 2007
© Biomedical Synergies, DB&A Inc., 2007
44
&
DB A
QC.5.300 (PC 17.10)
• Transport, handling, storage and use is
consistent with manufacturer’s written directions
(package insert)
– Maintain file of package inserts
– SOPs, training and audit of all steps involved in tissue
utilization
– Create procedure for transport and monitoring of
tissue when it leaves the storage site and criteria for
accepting it back if not used
– Many tissues are reconstituted in the OR, how to
audit that this is done properly?
SAFMLS – 26 February 2007
© Biomedical Synergies, DB&A Inc., 2007
45
&
DB A
QC.5.300 (PC 17.10)
• Incoming tissue from source facility
– Create a policy and procedure for how tissue
will be accepted into your organization and
who will be responsible for logging incoming
tissue. Maintain file of package inserts
– Maintain a log of incoming tissue that includes
but is not limited to the following elements:
unique ID number, expiration date, package
integrity, acceptable temperature range
SAFMLS – 26 February 2007
© Biomedical Synergies, DB&A Inc., 2007
46
&
DB A
QC.5.300 (PC 17.10)
• Monitoring
– Continuous temperature monitoring for
storage refrigerators and freezers
– Alarms and backup equipment
– Maintain records to prove tissue was stored
properly
– Computerized systems exist for tissue
monitoring as well as recipient tracking
SAFMLS – 26 February 2007
© Biomedical Synergies, DB&A Inc., 2007
47
&
DB A
The Joint Commission Standards for
Tissue Published July, 2005
QC.5.310 (PC 17.20)
The organization’s record keeping permits
the traceability of all tissues from the donor
or source facility to all recipients or other final
disposition.
SAFMLS – 26 February 2007
© Biomedical Synergies, DB&A Inc., 2007
48
&
DB A
AABB – Traceability
Standards 23rd Edition (2005)
5.1.6.2 - Traceability
The blood bank or transfusion service shall
ensure that all blood, components, tissue,
derivatives, and critical materials used in their
processing, as well as laboratory samples and
donor and patient records, are identified and
traceable
SAFMLS – 26 February 2007
© Biomedical Synergies, DB&A Inc., 2007
49
&
DB A
Case Study
• In 2000, an organ/tissue donor, negative for anti-HCV,
was in the window period for HCV.
• HCV was transmitted to multiple organ and vein allograft
recipients.
• The bone and tendons were not processed until 16
months later.
• Before these contaminated tissues were distributed, the
lung recipient was diagnosed with HCV and died 4
months before any bone or tendons were distributed.
• In addition, the distributor of cardiovascular tissue from
this donor had already been notified of HCV infections in
a vein recipient.
• If these infections had been reported to the tissue
processor recipients would not have been infected.
SAFMLS – 26 February 2007
© Biomedical Synergies, DB&A Inc., 2007
50
&
DB A
HCV From Seronegative Organ &
Tissue Donor
• Donor: Anti- HCV neg Oregon man, died of CVA
in 2000 and donated 6 organs and 80 tissues.
• Five organ recipients died by 2002
– Lung recipient, HCV infected, liver failure in 2nd yr
– HCV RNA found on day 4 but not pre-transplant blood
sample (tested in 2002)
• One kidney recipient - living asymptomatic of
HCV infection
• Tissue bank, eye bank were not notified
Tugwell, ASM Mtg Oct 2002
SAFMLS – 26 February 2007
© Biomedical Synergies, DB&A Inc., 2007
51
&
DB A
HCV From Seronegative Organ &
Tissue Donor
• Most Other Tissue Not Processed Until March 2002
– 80 Tissue Allografts Made
• April 17, 2002. Woman Received Patellar Ligament
– Six Weeks Later Acute Symptomatic Hepatitis C Developed
• June 27, 2002 - Tissue Bank Notified
–
–
–
–
–
–
Stored Donor Serum Found Positive for HCV RNA
Immediate Quarantine of Unused Tissue
44 Tissues Had Been Distributed and Were Recalled
34 Tissues Had Been Implanted
4 Recipients With Hepatitis (3 Before Transplant)
21 Recipients Not Yet Found
SAFMLS – 26 February 2007
© Biomedical Synergies, DB&A Inc., 2007
52
&
DB A
Traceability
• Track all tissues from time of login from
source facility to final disposition
• Training of staff who receive tissue in OR
and document the unique identifying
number for tissue on chart, tissue usage
information cards or log tissue return to
storage
• Computer software exists to track all
phases of tissue utilization
SAFMLS – 26 February 2007
© Biomedical Synergies, DB&A Inc., 2007
53
&
DB A
Traceability
• Based on the package insert, what supplies are used to
reconstitute for transplantation (e.g. syringes, heparin,
saline, etc.)
• Document that all supplies are in date
• Establish methods for tissue preparation based on
package insert
• Document staff training in proper preparation techniques
and documentation
• If tissue is not used in OR, there must be documentation
that the storage conditions in the OR allow the tissue to
be returned to the central storage area
• Reduce product loss in OR
SAFMLS – 26 February 2007
© Biomedical Synergies, DB&A Inc., 2007
54
&
DB A
Management of Autologous Tissue
• Types – skull flaps, iliac crest wedges,
parathyroid glands, ribs, skin
• Do procedures exist to collect, prepare, store,
test, culture tissue?
• Record keeping
• Will the surgeon ever use this tissue again?
• When can it be discarded?
• Notification to discard or of positive tests
SAFMLS – 26 February 2007
© Biomedical Synergies, DB&A Inc., 2007
55
&
DB A
Autologous Tissue Preservation
Tissue Preservation Kit
• Ensures standardized
packaging and storage
protocols
• Stored in OR for
immediate availability
• Self contained package
• Written instructions
• Service Request Form
acts as physician order
SAFMLS – 26 February 2007
© Biomedical Synergies, DB&A Inc., 2007
56
&
DB A
The Joint Commission Standards
for Tissue Published July, 2005
QC.5.320 (PC 17.30)
The organization has a defined process
to investigate adverse events to tissue
or donor infections
SAFMLS – 26 February 2007
© Biomedical Synergies, DB&A Inc., 2007
57
&
DB A
Prevention Of Disease Transmission
Via Transplantation
• Variables in Tissue Safety
– Tissue cellularity, viability and processing
– Limitations in processing tissues other than
bone
– Orthopedic practices
– Physician preference for certain proprietary products
– Pre and postoperative antibiotics
– Incidence of infections with allograft versus metallic
devices
– Gram stains and cultures
SAFMLS – 26 February 2007
© Biomedical Synergies, DB&A Inc., 2007
58
&
DB A
Investigating Adverse Events
• Define a reaction:
– Clinical symptoms
– Tissue cultured or gram stained
– Tissue or surgical infection
– How was tissue treated
Most tissue related infections are in tendons,
ligaments, and cardiovascular tissues; not bone
SAFMLS – 26 February 2007
© Biomedical Synergies, DB&A Inc., 2007
59
&
DB A
Investigating Adverse Events
• Create procedures for reporting potential
adverse reactions from a tissue transplant
• Who is responsible for receiving information
concerning adverse outcome?
• How are these events documented (e.g.
evaluation report, log, etc.)?
• Who is responsible for determining if the event
was secondary to the tissue implanted?
• Who notifies the source facility and receives
their evaluation and report?
SAFMLS – 26 February 2007
© Biomedical Synergies, DB&A Inc., 2007
60
&
DB A
Investigating Adverse Events
• Who is responsible for requesting additional
information, testing and completion of
investigation?
• All other tissues from this donor that the
institution may possess need to be traced and
quarantined
• Adverse event records shall be periodically
reviewed for completion
• Who will report findings to clinician?
• Who determines if the event must be reported to
regulatory agencies?
SAFMLS – 26 February 2007
© Biomedical Synergies, DB&A Inc., 2007
61
&
DB A
Biomedical Synergies
Suspected Adverse
Outcome Record
SAFMLS – 26 February 2007
© Biomedical Synergies, DB&A Inc., 2007
62
&
DB A
Articles
1. Tissue Storage and Issuance Standards.
Nursing Management. 36(4):14-15, April 2005.
Ulaskas, Cherie J.
2. Decreasing Latitude and Increasing Regulation
in Transplantable Tissue Programs.
AORN Journal, 82(5):806-814, Nov 2005. Humphries,
Linda
3. Meeting JCAHO's New Tissue Standards.
OR Manager 21(6):19-20, June 2005 Sawchuk, Megan
4. Tissue Banking Regulations and Oversight.
Clin Lab Med. 25(3):487-98, Sep 2005. Eisenbrey AB,
Frizzo, W.
SAFMLS – 26 February 2007
© Biomedical Synergies, DB&A Inc., 2007
63
&
DB A
Does your institution have to
register with the FDA as a
tissue bank?
SAFMLS – 26 February 2007
© Biomedical Synergies, DB&A Inc., 2007
64
&
DB A
Does Your Institution:
• Produce HCT/Ps including stem cells,
reproductive cells or tissue / surgical bone?
• Store purchased tissues and ship to another
institution not part of your organization - e.g.
Does your institution supply a VA Hospital or
other community hospitals?
• Perform additional processing on incoming
tissue (e.g. Gas sterilize bone for further use?)
• Test tissue donors samples for communicable
diseases? Does your lab test specimens for
organ donors and the results are then used to
determine eligibility for tissue donors?
SAFMLS – 26 February 2007
© Biomedical Synergies, DB&A Inc., 2007
65
&
DB A
David A. Buczek. M.A.
President, DB&A Inc.
• 24 years enterprise level business and technology
consulting experience
• Working with the Armed Services Blood Program Office
since 2002
• Principal Investigator of three Small Business Innovative
Research projects for OSD / MHS
• Lead designer for the Blood Bank Surveillance System,
automated system to capture and analyze rare event
data and automatically report out results to users
• Designed RFID solutions for blood banking, transfusion
services, plasma industry, and patient safety applications
• Led effort to develop a strategic business plan for the
DoD Patient Safety Program in 2006
SAFMLS – 26 February 2007
© Biomedical Synergies, DB&A Inc., 2007
66
&
DB A
How to Respond
•
•
•
•
Understand tissue management lifecycle
Understand the standards
“Audit” your environment for compliance
Define and Implement an improvement
project
• Initiate a holistic approach to compliant
tissue management
Where do I begin?
SAFMLS – 26 February 2007
© Biomedical Synergies, DB&A Inc., 2007
67
&
DB A
Tissue Management Lifecycle
Trusted Source
Bank / Distributor
Validation
Tissue
Ordering
Tissue
Receipt
Patient
Needs
Adverse Reaction
Look-Back
Tissue
Usage Info
Tracking
SAFMLS – 26 February 2007
Tissue
Implantation
© Biomedical Synergies, DB&A Inc., 2007
Tissue
Inventory
Management
Tissue
Preparation
68
&
DB A
Subgroup “Audit” Activity
• Break up into three groups
• Facilitated “Case Study” discussion
• Analyze your environment
against a new standard
• Report back to large group
STATION
3
SAFMLS – 26 February 2007
STATION
1
STATION
2
© Biomedical Synergies, DB&A Inc., 2007
69
&
DB A
Implications for Existing Operations
• PEOPLE - unfamiliar with tissue-related management
activities required to meet new standards.
• PROCESS - of tissue receipt, handling, tracking and lookback may not meet new standards.
• TECHNOLOGY - currently does not provide an enterprise
view of the tissue lifecycle within the organization required
by new standards.
• ORGANIZATION - has stove-piped groups handling
tissue with little incentive to work across organizational
boundaries.
SAFMLS – 26 February 2007
© Biomedical Synergies, DB&A Inc., 2007
70
&
DB A
A View Towards a Holistic Solution
Mission / Vision
T
H
E
C
H
A
N
G
E
Strategic Goals
T
H
E
Values
Objectives
Processes
Actions
Behaviors
C
U
L
T
U
R
E
Results
SAFMLS – 26 February 2007
© Biomedical Synergies, DB&A Inc., 2007
71
&
DB A
Tissue Management Change Model
Scope
Compliance
Change
Objectives
Future
State
Process
Compliance Gap
People
Current
State
Technology
Organization
Time
SAFMLS – 26 February 2007
© Biomedical Synergies, DB&A Inc., 2007
72
&
DB A
Tissue Management Reengineering
Project Phases
Discovery
Analysis
Design
Development
Implementation
In the Discovery
Phase the project
team defines the need
for change, at a high
level examines the
current state and
desired future state,
defines change
objectives, then maps
out a phased project
plan to achieve the
change objectives.
In the Analysis Phase
the project team
documents the
current state
processes, technical
environment and staff
skills; creates a
people, process and
technology map of the
desired future state;
and defines the gaps
between current and
future states.
In the Design Phase
the project team
identifies the best way
to close gaps
between current and
desired future states.
New processes,
supporting technology
and staff skill
requirements are
defined. Detailed
designs are created
for the new business
architecture.
In the Development
Phase the project
team creates detailed
process maps and
Standard Operating
Procedures,
technology
components are built
to spec, and staff are
trained on new
technology enabled
business processes
and SOPs. Full
testing is completed.
In the Implementation
Phase the project
team implements the
new business
architecture in the
client environment.
Staff with new skills,
use new processes,
enabled by new
technology to operate
in the desired future
state, according to the
new SOPs.
Analysis plan is
completed.
Design plan is
completed
Development plan is
completed
Implementation plan
is completed
Change Objectives
analysis completed
SAFMLS – 26 February 2007
© Biomedical Synergies, DB&A Inc., 2007
73
&
DB A
Getting Started – Define Gaps
Joint Commission and AABB
Tissue Standards Compliance Evaluation for Hospitals
• Independent audit of current written policies and
procedures to determine the extent of current compliance
with standards
• On-site inspection and audit to evaluate “real world”
adherence to written procedures
• Comprehensive plan to address deficiencies to include
SOPs with version control (including adverse reaction
procedures), assistance with implementation of SOPs,
training and education, and technology component (s)
• Post-implementation audit to ensure compliance
SAFMLS – 26 February 2007
© Biomedical Synergies, DB&A Inc., 2007
74
&
DB A
T
R
A
C
S
Tracking / Tracing
Recall
Adverse Reaction
Compliance
Software
SAFMLS – 26 February 2007
Cells
Tissues
Organs
Implants
Life!
© Biomedical Synergies, DB&A Inc., 2007
75
&
DB A
Key Features
•
•
•
•
Vendor qualification
Inventory management
Barcode generation and scanning capability
Tracing of product handling and storage
conditions
• Tracks products used in reconstitution of tissue
• Automatically completes tissue utilization
records for tissue processors
SAFMLS – 26 February 2007
© Biomedical Synergies, DB&A Inc., 2007
76
&
DB A
Key Features
• Integration available for most existing hospital systems
(OR system, A/P system, etc.) to reduce duplicate data
entry
• Maximizing effectiveness of data entry process
(reporting, recalls, PI, adverse reaction)
• Centralizes all tissue management information in one
database to improve workflow
• Database architecture can accommodate all tissues and
implants types
• Tissue banks may interface to assist in the tissue
management process (ordering, consignment, TUICs,
and adverse reactions)
• Assigns accountability in tissue management process
SAFMLS – 26 February 2007
© Biomedical Synergies, DB&A Inc., 2007
77
&
DB A
SAFMLS – 26 February 2007
© Biomedical Synergies, DB&A Inc., 2007
78
&
DB A
Questions ?
We’re here to help
DUKE KASPRISIN, M.D.
DAVID A. BUCZEK, M.A.
Chief Medical/Scientific Officer
Biomedical Synergies, Inc.
(802) 658-4862
DukeK@biomedicalsynergies.com
President
DB&A, Inc.
(703) 861-5332
dave@buczek.us
JEFF WINSTEAD, M.S.
Senior VP, Business Development
Biomedical Synergies, Inc.
(317) 842-6502
JeffW@biomedicalsynergies.com
SAFMLS – 26 February 2007
© Biomedical Synergies, DB&A Inc., 2007
79
&
DB A