Human Tissue Liability, Patient Safety and Regulatory Compliance

1
Human TissueLiability, Patient Safetyand
Regulatory Compliance

• DUKE KASPRISIN, M. D.
• Chief Medical/Scientific Officer
• Biomedical Synergies, Inc.
• DAVID A. BUCZEK, M.A.
• President
• DBA Inc.

2
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

3
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

4
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)
5
Prevention Of Disease Transmission Via
Transplantation

• Donor History Screening
• Donor Physical Exam
• Donor Blood Tests
• Issues concerning cadaveric samples
• Autopsy
• Tissue Processing Steps
• Compatibility

6
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.

7
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.

8
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.

9
Case Study

• Why did the fourth patient develop rabies?

10
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 couldnt be
  proven that the vessel absolutely came from the
  same donor.

11
HIV From Bone Tendon Allografts

• Case from unprocessed femoral head (live donor)
  prior to anti-HIV testing. Donor was IV drug
  user (MMWR 198837587)
• Cases from anti-HIV Neg organ tissue donor
  (donors in window period) (NEJM 1992326726)
• 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

12
HCV From Bone Tendon Allografts

• From frozen femoral head prior to anti-HCV test
  available
• Cases from 1990 anti-HCV 1.0 Neg
  donor(retrospectively Pos with anti-HCV 2.0) JBJS
  1995 77-A214
• Transmitted by frozen, unprocessed tendon bone
• Not transmitted by freeze-dried irradiated bone

13
Infectious Risks in Tissue Transplantation

• Window Period for Infection Before and After
• NAT Plus NAT
• Anti-HIV 22 days 7 days
• HBsAg 59 days 20 days
• Anti-HCV 70 days 7 days

Zou, et al. N Engl J Med 2004 351751-759
14
Infectious Risks in Tissue Transplantation

• Probability of a Viremic Tissue Donor Before and
  After NAT
• Current Post-NAT
• HIV 1/55,000 1/173,000
• HBV 1/34,000 1/100,000
• HCV 1/42,000 1/421,000

15
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- 200251(Mar
15)207-10
16
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 200251(Mar 15)207-10
17
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

18
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 200251(Mar 15)207-10
19
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 (39C)
• Chills

20
Recipient Outcome

• Re-admitted 6 days post-op 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

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)
21
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

22
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

23
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

24
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 patients.
Photo from http//brighamrad.harvard.edu/Cases/bwh
/hcache/119/step-1.html
25
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

26
Diseases Transmitted By Tissue Transplantation

• Bone Tendon Cartilage Cornea
• Bacteria Bacteria Bacteria
  Bacteria
• Hepatitis HIV Hepatitis B
• HCV HCV Rabies
• TB CJD
• HIV Yeast
• Skin Heart Valve Pericardium Dura
• Bacteria Bacteria Bacteria CJD
• HIV ? TB ? CJD
• ? CMV Yeast
• ? Hepatitis

27
How often do major adverse outcomes happen?

• We dont 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

28
Overview of Tissue Banking
Tissues Available

• Skin
• Bone
• Tendon
• Fascia
• Heart valves

• Blood vessels
• Pericardium
• Corneas
• Cellular components (e.g. chondrocytes)
• Reproductive tissues

29
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

30
Overview of Tissue Banking
Types of tissues available and their uses

• Spinal surgery
• Non-engineered
• Bone needs to be cut and shaped in OR

Tricortical ilium block
Unicortical ilium block
Bicortical ilium block
31
Overview of Tissue Banking
Types of tissues available and their uses

• Spinal surgery
• Engineered

32
Overview of Tissue Banking
Types of tissues available and their uses

• Demineralized bone matrix Used as a bone void
  filler

33
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

34
Prevention Of Disease Transmission Via
Transplantation

• Processing
• Tissue Processing Steps
• Cleaning, dilution
• Antibiotics
• Biocleanse
• AlloWash
• Clearant Process
• Radiation dose issues
• Alcohol
• Ethylene oxide
• Limitations in transplants other than bone

35
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

36
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

37
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.

38
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

39
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

40
Organizational Design to Meet Joint Commission
Standards
Cardiovascular tissue
Reproductive tissue
Musculoskeletal tissue
Skin
Orthopedic unit
Surgical Specialty units
Fertility clinic
Burn unit
Autologous ?
Look Familiar?
41
Organizational Design to Meet The Joint
Commission Standards
Musculoskeletal tissue
Cardiovascular tissue
Skin
Centralized Control And monitoring
Reproductive tissue
Autologous
42
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

43
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?

44
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/CFApps
  Pub/tiss/index.cfm
• Document state licensure if applicable
• Ensure that FDA registration validation is
  applicable and available for each tissue type
  from source facilities

45
QC.5.300 (PC 17.10)

• Transport, handling, storage and use is
  consistent with manufacturers 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?

46
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

47
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

48
The Joint Commission Standards for Tissue
Published July, 2005

• QC.5.310 (PC 17.20)

The organizations record keeping permits the
traceability of all tissues from the donor or
source facility to all recipients or other final
disposition.
49
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
50
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.

51
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
52
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

53
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

54
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

55
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

56
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

57
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

58
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

59
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
60
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?

61
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?

62
Biomedical Synergies Suspected Adverse Outcome
Record
63
Articles

• 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.

64
Does your institution have to register with the
FDA as a tissue bank?
65
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?

66
David A. Buczek. M.A.President, DBA 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

67
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?
68
Tissue Management Lifecycle
Trusted Source Bank / Distributor Validation
Tissue Ordering
Tissue Receipt
Tissue Inventory Management
Patient Needs
Adverse Reaction Look-Back
Tissue Usage Info Tracking
Tissue Implantation
Tissue Preparation
69
Subgroup Audit Activity

• Break up into three groups
• Facilitated Case Study discussion
• Analyze your environmentagainst a new standard
• Report back to large group

70
Implications for Existing Operations

• PEOPLE - unfamiliar with tissue-related
  management activities required to meet new
  standards.
• PROCESS - of tissue receipt, handling, tracking
  and look-back 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.

71
A View Towards a Holistic Solution
T H E C U L T U R E
T H E C H A N G E
72
Tissue Management Change Model
Scope
Compliance
Change Objectives
Future State
Compliance Gap
Current State
Time
73
Tissue Management ReengineeringProject 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.
Analysis plan is completed.
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. Design plan is completed
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. Development plan is
completed
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. Implementation plan 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. Change Objectives analysis
completed
74
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

75
Tracking / Tracing
Recall
Adverse Reaction
Compliance
Software
76
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

77
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

78
(No Transcript)
79
Questions ?

• Were here to help

DUKE KASPRISIN, M.D. Chief Medical/Scientific
Officer Biomedical Synergies, Inc. (802)
658-4862 DukeK_at_biomedicalsynergies.com
DAVID A. BUCZEK, M.A. President DBA, Inc. (703)
861-5332 dave_at_buczek.us
JEFF WINSTEAD, M.S. Senior VP, Business
Development Biomedical Synergies, Inc. (317)
842-6502 JeffW_at_biomedicalsynergies.com