Presented by Skye Rivera, CQA ASQ

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Quality and ComplianceThe Tissue Circle

• Presented by Skye Rivera, CQA (ASQ)
• Quality Systems Manager, OneLegacy
• Thank you to Beverly Jacoby, HSC for input and
  guidance.

June 6, 2007 Celebrating Our PartnersDonation
Transplantation Conference and Awards Ceremony
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The Tissue Circle
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Regulation/Standard Overview

• Hospitals
• CMS Regulations
• Joint Commision (JCAHO) Standards
• Tissue Banks
• Food and Drug Administration (FDA) Regulations
• CA Dept. of Health Svcs. (CDHS) Regulations
• American Association of Tissue Banks (AATB)
  Standards
• Eye Bank Association of America (EBAA) Standards

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Regulations/Standards Observations

• CMS?FDA/AATB/EBAA?Joint Commision
• Each picks up where the other leaves off
• All require
• Procedures to be developed and maintained
• Procedures to be followed
• Accountability for following procedures

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Purpose of Regulations/Standards

• Tissue traceability
• Quality tissue supply
• Recipient safety
• Public health

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CDHS

• Sections 1635-1635.2 and 1639-1641.1
• Annual tissue bank registration
• Inspects tissue banks
• Safe preservation, transportation, storage and
  handling of tissue acquired or used for
  transplantation.
• Testing or assessment of donors to prevent the
  spread of disease through transplantation.

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FDA
Prevent the introduction, transmission, and
spread of communicable diseases by HCT/Ps
21 CFR Part 1271 Human Cells, Tissues, and
Cellular and Tissue Based Products (HCT/Ps)
Current Good Tissue Practices (CGTPs)
Core CGTPs
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How does FDA regulate tissue banking?

• Registration with FDA
• Submit list of tissues recovered processes
  performed
• Update annually when changes occur
• Inspection
• Verification that procedures exist to follow core
  CGTPS compliance to procedures
• Occurs on a regular basis (1-2 years) or for
  cause
• Duration depends on scope, inspector, observations

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How does FDA regulate tissue banking?

• Deviation Adverse Event Reporting
• Distributed tissues only
• FDA investigates and follows up

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Core CGTPs

• Specific regulations for tissue banking
  operations
• Applicable to all Core CGTPS
• Procedures must be established and maintained
• Documentation and maintenance of records must be
  performed

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Core CGTPsRecovery-Related

• Facilities
• Equipment
• Supplies reagents
• Recovery
• Storage
• Pre-distribution shipment
• Donor screening

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Quality Program (1271.160)

• Comprehensive system for manufacturing tracking
  tissues
• Traceability of tissue from donor to recipient
• Prevent, detect, and correct deficiencies that
  may lead to circumstances that increase the risk
  of introduction, transmission, or spread of
  communicable diseases

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Quality Program (1271.160)

• Establish maintain procedures
• Ensure compliance with procedures
• Investigate evaluate complaints
• Share information with tissue bank partners
• Ensure short term long term corrective actions
  are performed to correct deficiencies

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Quality Program (1271.160)

• Reaudit verify effectiveness of corrective
  actions
• Training education of personnel
• Investigate document deviations trends
• Perform periodic quality audits for management
  review
• Computer validation

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OneLegacy Quality Systems

• Records Management
• Policy Procedure Document Control
• Training
• Deviations and Corrective and Preventive Action
• Internal and External Audits

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Hospital Support

• Hospitals can support OneLegacy to meet
  regulations
• Relevant Regulations
• 21 CFR Part 1271 Human Cells, Tissues, and
  Cellular and Tissue Based Products
• CGTPs (Current Good Tissue Practices)
• Guidance for Industry Eligibility Determination
  for Donors of Human Cells, Tissues, and Cellular
  and Tissue-Based Products (HCT/Ps)

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Quality Compliance in the Hospital

• Time and logistics
• Donor screening
• Plasma dilution
• Critical information
• Critical documentation
• Physical inspection
• Serology specimen collection
• Recovery

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What is Quality?

• Providing safe transplantable tissue
• Fulfilling donors wishes
• Fulfilling donor familys wishes
• Ensuring best donation outcome
• Supportive and successful relationships with
  hospitals, coroners, and funeral homes
• What else?

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Time and Logistics

• Time limits for cornea recovery
• Refrigerated w/in 10 hours of death
• 2-50 years -- 20 hours
• 51-70 years -- 18 hours
• 71 years -- 16 hours
• Not refrigerated w/in 10 hours of death
• 2-71 years -- 10 hours

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Time and Logistics

• General time limits for multi-tissue recovery
• Refrigerated within 12 hours of death 24 hours
• Not refrigerated 15 hours
• Saphenous vein recovery
• 12 hours regardless of refrigeration
• Tissue processors can have additional time
  criteria

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Time and Logistics

• Timely referral is critical?CLINICAL TRIGGER CARD
• Need accurate time of death
• Pronouncement
• Last seen/known alive
• Is Pulseless Electrical Activity (PEA)
  substantiated?
• Refrigeration info.
• Time, duration, and type
• Logistical issues, i.e. transportation, coroner,
  funeral home

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Donor Screening

• To determine if patient is eligible for tissue
  donation
• Patient must be free from
• Risk factors for, and clinical evidence of,
  infection due to relevant communicable disease
  agents and disease (RCDADs)
• Communicable disease risks association with
  xenotransplantation

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Medical Directors

• OneLegacy Tissue Services
• Multi-Tissue Medical Director
• Ocular Medical Director
• Consulted on medical issues in donor screening
• Tissue Processors
• Medical Director performs donor eligibility
  determination to release tissue for transplant

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Relevant Communicable Disease Agents/Diseases

• HIV 1 and 2
• HBV
• HCV
• Human transmissable spongiform encephalopathy
  (TSE), i.e. CJD
• Syphilis
• West Nile Virus (WNV)
• Sepsis
• Vaccinia
• Any disease that can be transmitted through
  transplantation (i.e. bacteria, fungi, virus,
  parasite, prion)

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High risk factors or conditions, general examples

• Alzheimers, dementia
• Male with male sex
• Non-medical IV drug use
• Sex for money or drugs
• Non-sterile tattoos
• Jail or prison
• Gang activity
• Possible exposure to HIV or hepatitis
• Sepsis

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Serology Testing

• Hepatitis Bs Ag
• Hepatitis Bc (Total) Ab
• HTLV I/II Ab
• HIV 1 2 Ab
• RPR (Rapid Plasma Reagin) for Syphilis
• ABO/Rh Blood Type
• HIV-1 TMA Singlet Result
• HCV TMA Singlet Result
• Chagas for select heart valve donors

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Plasma Dilution

• To determine if blood specimen is suitable for
  communicable disease testing
• Collect specimen within 7 days of tissue recovery
• Option 1 Pre-trans/infusion sample
• Option 2 Evaluate trans/infusions with algorithm
  
• Blood or colloids within 48 hours before death or
  specimen collection
• Crystalloids within 1 hour before death or
  specimen collection

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Critical Hospital Information

• Refrigeration
• Relevant communicable disease agents/ diseases
• Xenotransplantation
• High risk factors or conditions
• Transfusions and infusions

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Critical Hospital Documentation

• Medical records from current hospital admission
• Flow sheets
• Chest X-Ray Reports
• Preliminary and Final Blood, Urine, Sputum, CSF
  Culture Results
• Known or likely cause of death

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OneLegacy at the Hospital

• Communicate with hospital staff regarding
  recovery and patient issues
• Review medical records, consent, and medical and
  social history questionnaire
• Evaluate and clean recovery environment (i.e. OR,
  morgue)
• Collect/evaluate blood specimen
• Physical assessment of the patient (donor
  screening)

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OneLegacy the Hospital

• Establish aseptic environment
• Recover tissue
• Using sterile/sanitized equipment and supplies
• Collect pre-processing culture specimens
• Reconstruction
• Clean recovery site
• Communicate patient arrangements

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OneLegacy

• Package tissue
• Label tissue with unique identifier
• Ship blood specimen to lab
• Ship tissue to tissue processors
• Share all patient information with all processors

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Tissue Processors

• Contracted by OneLegacy
• Tissue processors for each patient are determined
  based on
• Donor service area
• Consent allowances
• Processor criteria
• Each processor has unique criteria and procedures
  for tissue recovery and donor eligibility

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Tissue Processors

• Receive tissue immediately after recovery
• Interface with OneLegacy to obtain all
  documentation and information Process tissue
• Perform donor eligibility determination
• Release or reject for transplant
• Store tissue
• Distribute tissue to hospitals

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Tissue Processors

• Each has their own speciality
• Cardiovascular (Heart Valves and Vascular Tissue)
• Musculoskeletal (Bones and Soft Tissue)
• Ocular (Corneas, Sclera, and Whole Globes)
• Skin (Full Thickness and Split Thickness)
• Research Development
• Unique processes (Sanitization, Sterilization,
  Modification)
• Unique transplantable products (Size, Shape, Form)

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Core CGTPsProcessor-Related

• Storage
• Recovery
• Receipt, pre-distribution shipment, and
  distribution
• Donor eligibility determination, donor screening,
  and donor testing

• Facilities
• Environmental control
• Equipment
• Supplies reagents
• Processing process controls
• Labeling controls

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Tissue in the Hospital

• New Joint Commission Standards
• PC.17.10 Acquire, Receive Store Tissue
• PC.17.20 Tissue Traceability
• PC.17.30 Investigate Adverse Events

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PC.10.17

• Are you a source facility?
• Register with the FDA
• Register with the CDHS
• Resource to Validate Source Facility
  https//www.accessdata.fda.gov/scripts/cber/CFApps
  Pub/tiss/index.cfm
• Document package integrity/temperature
  verification upon receipt

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PC.10.17 (continued)

• Tissue Storage
• Identify storage location(s) of each tissue
• Identify unit on which recording device is
  located
• Document temperature verification on a daily
  basis
• Perform routine alarm verification
• Create procedure for handling out-of-range
  temperature deviations (they will happen)
• Create procedure for tissue disposition if
  deviation occurs

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PC.17.20

• Are you assigning a different tissue ID ?
• Ensure traceability back to tissue processor ID
• Need to be able to perform a look back
• Audit to ensure record trail is effective
• Think of Hansel and Gretal
• Critical documentation at all steps (Receipt,
  Storage, Transport, Transplant, Discard, Return)
• Back up data or records (cant afford to lose)

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PC.17.30

• Procedures for investigation of adverse events
  must be in place
• Tissue processors need ALL information you can
  provide
• Report even if tissue is not suspected for
  adverse event

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Questions Suggestions

• Questions
• How can OneLegacy and hospitals help each other
  to improve quality tissue donation?
• What is happening that does not result in quality
  tissue donation?
• Suggestions
• Lets create a dialogue.
• Lets learn from each other.

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Contact Information

• Skye Rivera
• Quality Systems Manager, OneLegacy
• Office Phone [phone]
• Cell Phone [phone]
• Email srivera_at_onelegacy.org
• Address
• 1701 Orange Tree Lane, Redlands, CA, 92374

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