Policies & Precautions

Policies

• IIDP Policies and Procedures
• Minimal IIDP Criteria for Accepting Human Cadaveric Pancreata for Islet Isolationt

Precautions

• The 2007 Guideline for Isolation Precautions: Preventing Transmission of Infectious Agents in Healthcare Settings

Standard Operating Procedures

SHP-002 Flash Freezing Unclaimed Islets

• SHP-002 Flash Freezing Unclaimed Islets
• • Attachment 1-Supply List
  • Attachment 2-Flash Frozen Log Sheet
  • Attachment 3-Flash Frozen Inventory, Broadcasting Staff User’s Guide
  • Attachment 4-Flash Frozen Inventory, Investigator User’s Guide

SHP-003 Standardized International Shipping Documentation

• SHP-003 Standardized International Shipping Documentation
• • Attachment 1-Fedex Shipping Label
  • Attachment 2-Commercial Invoice
  • Attachment 3-Declaration of Biological Shipments (Fillable)
  • Attachment 4-Commercial Invoice (Fillable)

SHP-004 Culture and Preparation for Cold Shipping

• SHP-004 Culture and Preparation for Cold Shipping
• • Attachment 1-Ciprofloxacin Stock Preparation

SHP-005 Cold Shipping of Human Islets

• SHP-005 Cold Shipping of Human Islets
• • Attachment 1-Tips for Determining Islet Quality for Shipping
  • Attachment 2-Tips for Efficiency in Packaging
  • Attachment 3-Packaging Islets for Cold Shipping Demonstration
  • Attachment 4-Tip Temp Handling Instructions
  • Attachment 5-Ciprofloxacin Stock Preparation

QA-001 Qualitative & Quantitative Assessment of Human Purified Islets for Distribution Using Dithizone (DTZ)

• QA-001 Qualitative & Quantitative Assessment of Human Purified Islets for Distribution Using Dithizone (DTZ)
• • Attachment 1-Counting Worksheet
  • Attachment 2-Islet Ranking Guide
  • Attachment 3-Editable Counting Work-Sheet

QA-002 Viability Estimation of Islets for Distribution Using Inclusion and Exclusion Fluorescent Dyes (FDA/PI)

• QA-002 Viability Estimation of Islets for Distribution Using Inclusion and Exclusion Fluorescent Dyes (FDA/PI)
• • Attachment 1-Preparation Fluorecein Diacetate and Propidium Iodide Solutions
  • Attachment 2-Islet Viability Worksheet

QA-003 Microbiology Testing for Islets for Distribution

• QA-003 Microbiology Testing for Islets for Distribution
• • Attachment 1-Microbiology Tracking Worksheet

QA-004 Sentinel Flask Preparation

• QA-004 Sentinel Flask Preparation
• • Attachment 1-Sentinel Flask Preparation

QA-005 Potency Test: Glucose Stimulated Insulin Release Assay

• QA-005 Potency Test: Glucose Stimulated Insulin Release Assay
• • Attachment 1-Solution Preparation Sheets
  • Attachment 2-Microtiter Plate Layout
  • Attachment 3-GSIR Worksheet

QA 006 Uploading of Digital Image of Count Sample

• QA-006 Acquisition and Uploading of Digital Image of Count Sample for Broadcast

QA 007 Preparing Pancreas Section for Histology

• QA-007 Preparing Pancreas Section for Histology
• • Attachment 1-Histology Log Sheet
  • Attachment 2-FedEx Reimbursement Invoice Template