Common Quality
o ABMT-GEN-014 Data Management
o ABMT-GEN-036 Gamida Cell: Transplant Center Training: Thawing & Preparation to Infuse
o ABMT-GEN-037 Gamida Cell: Transplant Center Receive and Store
o APBMT-COMM-027 Adult and Pediatric Blood and Marrow Transplant Program Quality Management Plan
o APBMT-COMM-028 Performance Improvement Plan and Reporting
o APBMT-COMM-033 Records Management
o COMM-PAS-001 Third Party Agreement
o COMM-PAS-002 Records Retention Schedule
o COMM-PAS-003 Labeling Cellular Therapy Products
o COMM-PAS-003 JA1 Storage Temperature and Expiration of Cellular Products
o COMM-PAS-003 JA2 Cellular Therapy Product Labeling (Appendix II)
o COMM-PAS-005 Labeling Overview
o COMM-PAS-006 Product Complaint Management
o COMM-PAS-006 FRM1 Complaint Form
o COMM-PAS-008 Electronic Record Systems for Clinical Programs
o COMM-PAS-009 Electronic Record Systems for Clinical Programs Transplant Outcomes Database
o COMM-PAS-010 Electronic Record Systems for Clinical Programs: ABMT Database
o COMM-PAS-011 Electronic Record Systems for Clinical Programs: PBMT Database
o COMM-PAS-012 Electronic Record Systems for Clinical Programs: Brain Injury REDCap
o COMM-PAS-013 Deviations and Investigations
o COMM-PAS-013 FRM1 Deviation and Investigation Report
o COMM-PAS-013 JA1 Root Cause Analysis Job Aid
o COMM-PAS-013 JA2 Vendor Event Job Aid
o COMM-PAS-014 Risk Assessment Procedure
o COMM-PAS-015 Corrective and Preventive Actions
o COMM-PAS-015 FRM1 CAPA Report
o COMM-PAS-016 Approaches to Validation
o COMM-PAS-016 FRM1 Instrument Equipment Validation Protocol
o COMM-PAS-016 FRM2 Analytical Validation Protocol
o COMM-PAS-016 FRM3 Process Validation Protocol
o COMM-PAS-017 Supplier Qualifications
o COMM-PAS-017 FRM1 Supplier Questionnaire
o COMM-PAS-017 FRM2 Supplier Impact Assessment
o COMM-PAS-017 FRM3 Supplier Quality Agreement
o COMM-PAS-017 FRM4 Service Provider Quality Agreement
o COMM-PAS-017 JA1 Supplier Risk Assessment
o COMM-PAS-018 Clinical Quality Program (CQP) Audit Procedure
o COMM-PAS-018 FRM1 Internal CQP Quality and Process Audit Report
o COMM-PAS-018 FRM2 APBMT Transplant Essential Data (TED) Form Audit Report
o COMM-PAS-018 FRM3 APBMT Chemotherapy and Treatment Plan Audit Report
o COMM-PAS-018 FRM4 APBMT IEC Therapy Safety Endpoints and Toxicity Management Audit Report
o COMM-PAS-018 FRM5 Supplier Qualification Audit Report
o COMM-PAS-018 FRM6 Internal CQP Facility Qualification-Requalification Audit Report
o COMM-PAS-018 JA1 CQP Audit Schedule for the APBMT Program and STCL
o COMM-PAS-019 Inspections by Outside Agencies
o COMM-PAS-019 FRM1 Audit Records Log
o COMM-PAS-019 FRM2 Document Request Tracking Form
o COMM-PASS-019 FRM3 Audit Attendee Signature Log
o COMM-PAS-019 FRM4 Auditor Signature Log
o COMM-PAS-019 JA1 Inspection Notification List
o COMM-PAS-020 Utilization of a Donor Medical History Addendum
o COMM-PAS-020 FRM1 Donor Risk Questionnaire Addendum - Coronavirus
o COMM-PAS-020 FRM2 Donor Risk Questionnaire Addendum - Coronavirus (Spanish)
o COMM-PAS-020 FRM3 Donor Risk Questionnaire Addendum- Monkeypox
o COMM-PAS-020 FRM4 Donor Risk Questionnaire Addendum- Monkeypox- Spanish
o COMM-PAS-021 MasterControl Portal & Document System Configuration and Administration
o COMM-PAS-021 JA1 Disable a User Account in MasterControl
o COMM-PAS-021 JA3 Portal Configuration
o COMM-PAS-022 Configuration of Numbering Series Patterns in MasterControl
o COMM-PAS-023 System Administration for MasterControl Organizers
o COMM-PAS-024 MasterControl Process System Configuration and Administration
o COMM-PAS-025 MasterControl HTML Form Implementation Procedure
o COMM-PAS-025 FRM1 MasterControl HTML Form Verification Request
o COMM-PAS-025 JA1 MasterControl HTML Form Verification
o COMM-PAS-026 Document Control Procedures for MasterControl
o COMM-PAS-026 JA1 Approving-Releasing a Document Infocard and Creating a Course Infocard
o COMM-PAS-027 Procedure Development
o COMM-PAS-027 JA1 Procedure Development SOP Template JA1
o COMM-PAS-028 Procedure Management
o COMM-PAS-028 FRM1 Weekly QC Document Control FRM1
o COMM-PAS-029 Management Review and Responsibility
o COMM-QA-002
Supplier Qualifications
o COMM-QA-002 FRM1 Supplier Questionnaire
o COMM-QA-002 FRM2 Supplier Impact Assessment
o COMM-QA-002 FRM4 Service Provider Quality Agreement
o COMM-QA-002 FRM5 Supplier Quality Agreement
o COMM-QA-002
JA1 Supplier Risk Assessment
o COMM-QA-016 Procedure Management
o COMM-QA-016 FRM2 Weekly QC Document Control
o COMM-QA-016 FRM3 Impact Assessment for Documents Printed with Missing HeaderFooter
o COMM-QA-019
FRM1 Change Control Request (Effectiveness Check)
o COMM-QA-019
FRM2 Change Control Request (No Effectiveness Check)
o COMM-QA-039
Quality Systems Unit Audit
o COMM-QA-039 JA1 Internal Quality Systems Unit Audit Report
o COMM-QA-039 JA3 QSU Audit Schedule Transplant Programs - STCL
o COMM-QA-039 JA5 Supplier Qualification Audit Report
o COMM-QA-039 JA6 Internal Quality Systems Facility Qualification/Requalification Audit Report
o COMM-QA-039 JA7 APBMT Chemotherapy and Treatment Plan Audit
o COMM-QA-039 JA8 Audit Guidance - Cord Blood Collection Site
o COMM-QA-039 JA10 APBMT Transplant Essential Data (TED) Form Audit
o COMM-QA-040
Inspections by Outside Agencies
o COMM-QA-040 FRM1 Audit Records Log
o COMM-QA-040
FRM2 Document Request Form
o COMM-QA-040 FRM3 Audit Attendee Signature Log
o COMM-QA-040 FRM4 Auditor Attendee Signature Log
o COMM-QA-040
JA1 Inspection Notification List
o COMM-QA-042 Deviations and Investigations
o COMM-QA-042 FRM4 Deviation and Investigation Report
o COMM-QA-042 JA3 Root Cause Analysis Job Aid
o COMM-QA-042 JA4 Vendor Event Job Aid
o COMM-QA-044
Approaches to Validation
o
COMM-QA-044 FRM1 Instrument Equipment Validation Protocol
o COMM-QA-044
FRM2 Analytical Validation Protocol
o COMM-QA-044
FRM3 Process Validation Protocol
o COMM-QA-055 Training Overview
o COMM-QA-056 EMMES Data Management System Overview
o COMM-QA-057
Procedure Development
o COMM-QA-057
JA1 Procedure Development SOP Template
o COMM-QA-060
MasterControl User Procedures - Documents
o COMM-QA-061
MasterControl User Procedures - Documents for View-Only Users
o COMM-QA-062
MasterControl User Procedures - Training
o COMM-QA-065 MasterControl User Procedures - HTML Forms
o COMM-QA-066 Review of Documents in MasterControl
o COMM-QA-073 Accessing Documents in MasterControl through the EXPLORER
o COMM-QA-075 Management Review and Responsibility
o COMM-QA-076 Corrective and Preventive Actions
o COMM-QA-076 FRM1 CAPA Report
o COMM-QA-077 Risk Assessment Procedure
o COMM-QA-078 Good Tissue Practice (GTP)
o COMM-QA-080 Quality Risk Management
o COMM-QA-081 Utilization of a Donor Medical History Addendum
o COMM-QA-081 FRM1 DONOR RISK QUESTIONNAIRE Addendum - Coronavirus
o COMM-QA-081 FRM2 Donor Risk Questionnaire Addendum - Coronavirus (Spanish)
o COMM-QA-081 FRM3 Donor Risk Questionnaire Addendum- Monkeypox
o COMM-QA-081 FRM4 Donor Risk Questionnaire Addendum- Monkeypox- Spanish
o COMM-QA-082 MasterControl HTML Form Implementation Procedure
o COMM-QA-082 FRM1 MasterControl HTML Form Verification Request
o COMM-QA-082 JA1 MasterControl HTML Form Verification
Overview
Clinical
Collection
Donor Selection and Evaluation
Stem Cell Laboratory (STCL)
STCL-Processing and Distribution
o STCL-DIST-001 Blood Component Storage and Distribution
o STCL-DIST-001 FRM1 HPC Return from Issue Form
o STCL-DIST-001 JA1 Incoming NMDP Products - STCL Checklist
o STCL-DIST-001 JA2 Outgoing NMDP Products - STCL Checklist
o STCL-DIST-003 Cellular Product Distribution Form
o STCL-DIST-006 Shipping Cryopreserved Cellular Therapy Products to Transplant Centers
o STCL-DIST-006 FRM1 Courier Chain of Custody
o STCL-DIST-006 FRM2 Adverse Event Reporting Form
o STCL-DIST-006 FRM3 Post Thaw Evaluation Worksheet
o STCL-EQUIP-002 Sysmex XS-1000i Hematology Analyzer for the Stem Cell Laboratory
o STCL-EQUIP-002 FRM1 Sysmex XS-1000i QC Review Log
o STCL-EQUIP-002 FRM2 Sysmex XS-1000i Maintenance Log
o STCL-EQUIP-002 FRM3 Sysmex XS QC Review Log - Weekly and Monthly
o STCL-EQUIP-002 JA1 Sysmex XS-1000i Automated Hematology Analyzer Quality Control Management
o STCL-EQUIP-002 JA2 Sysmex XS-1000i Hematology Analyzer Reagent Replacement
o STCL-EQUIP-002 JA3 Sysmex XS-1000i Hematology Analyzer Dilution Protocol
o STCL-EQUIP-002 JA4 Sysmex XS-1000i Hematology Analyzer as Needed Maintenance
o STCL-EQUIP-002 JA5 Sysmex XS-1000i Hematology Analyzer Precision and Calibration Checks
o STCL-EQUIP-003 Operation of Sorvall RC-3C Plus Series Refrigerated Centrifuges
o STCL-EQUIP-003 JA1 Programs for Sorvall 3 C Series Centrifuges
o STCL-EQUIP-004 Operation of Biological Safety Cabinets
o STCL-EQUIP-004 FRM1 Biological Safety Cabinet Maintenance Schedule
o STCL-EQUIP-005 Control Rate Freezing Using CryoMed
o STCL-EQUIP-005 FRM1 Control Rate Freezers Semi-Annual-Annual QC-PM Record
o STCL-EQUIP-005 JA1 Review of Control Rate Freezing Graphs
o STCL-EQUIP-005 JA2 Control Rate Freezer Checklist
o STCL-EQUIP-011 Sterility Culture Using the BacT-Alert Microbiology System
o STCL-EQUIP-011 FRM1 BacT Alert Log Sheet
o STCL-EQUIP-011 FRM2 OOS - Product Sterility
o STCL-EQUIP-011 JA1 Unloading the BacT-ALERT Microbiology System and Printing Reports
o STCL-EQUIP-012 WESCOR 7120 Aerospray Hematology Stainer
o STCL-EQUIP-012 FRM1 Wescor Hematology Slide Stainer Maintenance Log
o STCL-EQUIP-013 JA1 Refrigeration Call List
o STCL-EQUIP-014 Instructions for Oxygen Depletion Alarm
o STCL-EQUIP-016 Liquid Nitrogen Storage System
o STCL-EQUIP-016 FRM1 LN2 Preventive Maintenance Checklist
o STCL-EQUIP-016 FRM2 LN2 Distribution System Bi-Annual Checklist
o STCL-EQUIP-016 JA1 LN2 Distribution System Preventive Maintenance
o STCL-EQUIP-016 JA2 LN2 System Piping Diagram for North Pavilion
o STCL-EQUIP-016 JA3 Access Instructions for 2309B Pratt Street Freezer Building
o STCL-EQUIP-017 Operation of Beckman Coulter Allegra 6KR Centrifuge
o STCL-EQUIP-019 Operation of Sterile Tubing Welder
o STCL-EQUIP-019 FRM1 Sterile Welder Daily QC and Maintenance Log
o STCL-EQUIP-020 Operation of Medfusion/Protege 3010/3010A Syringe Pumps
o STCL-EQUIP-021 Temperature and Environmental Monitoring Systems for the Stem Cell Laboratory
o STCL-EQUIP-021 JA1 Rees Scientific Centron Presidio User Guide
o STCL-EQUIP-021 JA2 Duke University Users Guide-Building Automation Systems
o STCL-EQUIP-021 JA3 Duke University Users Guide-Hospital Refrigeration
o STCL-EQUIP-021 JA4 Quick Guide to Responding to REES Alarms
o STCL-EQUIP-022 Operation of Cellometer Auto 2000
o STCL-EQUIP-022 FRM1 STCL Cellometer Bead Daily Check
o STCL-EQUIP-022 JA1 Cellometer Auto 2000 Users Manual
o STCL-EQUIP-022 JA2 Cellometer Program Used for Thawed MSC Products
o STCL-EQUIP-023 Sysmex XN-450 Hematology Analyzer Automated Blood Count Procedures for the STCL
o STCL-EQUIP-023 FRM1 Sysmex XN-450 QC Review Log - DAILY
o STCL-EQUIP-023 FRM2 Sysmex XN-450 Maintenance Log
o STCL-EQUIP-023 FRM3 Sysmex XN-450 QC Review Log - Weekly and Monthly
o STCL-EQUIP-023 JA1 Sysmex XN-450 Automated Hematology Analyzer Quality Control Management
o STCL-EQUIP-023 JA2 Sysmex XN-450 Hematology Analyzer Reagent Replacement
o STCL-EQUIP-023 JA3 Sysmex XN-450 Hematology Analyzer Dilution Protocol
o STCL-EQUIP-023 JA4 Sysmex XN-450 Hematology Analyzer As Needed Maintenance
o STCL-EQUIP-023 JA5 Sysmex XN-450 Hematology Analyzer Precision and Calibration Checks
o STCL-PROC-002 Processing of ABO Incompatible Cellular Products
o STCL-PROC-004 Processing Granulocytes for Infusion
o STCL-PROC-004 FRM1 Granulocyte Pheresis Worksheet
o STCL-PROC-007 Peripheral Blood Progenitor Cell-HPC Apheresis-Concentration and Preparation for Cryopreservation
o STCL-PROC-012 Hetastarch Depletion Procedure
o STCL-PROC-015 CD 34 Positive Selection Using Miltenyi CliniMACS
o STCL-PROC-015 FRM1 CD 34 CliniMACS Worksheet
o STCL-PROC-015 FRM2 Certificate of Analysis COA for Autologous CD34+ Selections
o STCL-PROC-015 FRM3 CD34+ Certificate of Analysis (COA) for Clinimacs Allogeneic Donors FRM3
o STCL-PROC-015 FRM4 Cell Selection - Product at Receipt/Pre-Processing/Pre-Column Form
o STCL-PROC-015 FRM5 Graft Characterization Form for CTN 1301 Protocol
o STCL-PROC-015 FRM6 Certificate of Analysis for CTN 1301 Protocol
o STCL-PROC-015 FRM7 CliniMACs Instrument Checklist
o STCL-PROC-015 JA1 Auto CD34-Selected PBPCS for Treatment of Severe Crohn's Disease
o STCL-PROC-015 JA2 Preparation of Bone Marrow before CD34+ Selection Procedure
o STCL-PROC-015 JA4 CliniMACS® CD34+ Cell Selection CTN 1301
o STCL-PROC-015 JA5 CD34 Selection Cheat Sheet
o STCL-PROC-015 JA6 CliniMACS User Manual US Edition
o STCL-PROC-018 Correct Connection of Pre-system Filter and Tubing Set-CliniMACS
o STCL-PROC-019 CD56+ Selection Using the CliniMACS
o STCL-PROC-019 FRM1 CD56+ Selection Worksheet
o STCL-PROC-019 FRM2 CD56+ Certificate of Analysis
o STCL-PROC-019 JA1 CD56 Selection Cheat Sheet
o STCL-PROC-021 JA1 Checklist for 37 Degree Thaws Performed Off-Site 01
o STCL-PROC-023 Procedure for Operating Hemocytometers
o STCL-PROC-024 Coverslip Preparation
o STCL-PROC-025 Cryopreservation of Back Up Cells from Original UCB Reinfusion
o STCL-PROC-028 Standard Peripheral Stem Cell Processing and Preparation for Infusion or Cryopreservation
o STCL-PROC-032 Monitoring Cell Yields after Apheresis Collection
o STCL-PROC-033 FRM1 Cellular Product Storage Location Confirmation
o STCL-PROC-035 Manual Cell Differential (Slide Method), CBUs for CCBB Program
o STCL-PROC-035 FRM1 Manual Differential, Cord Blood Units
o STCL-PROC-036 Thawing and Washing Umbilical Cord Blood Units Using an Automated Sepax System
o STCL-PROC-037 Preparation of CMV-Specific Donor Lymphocytes Infusions Using the Miltenyi CliniMACS
o STCL-PROC-037 FRM1 Miltenyi Large Scale CCB IFN-gamma Worksheet
o STCL-PROC-038 CD45 RA+ T Cell Depletion Using Miltenyi CliniMACS
o STCL-PROC-038 FRM1 CD45+RA Depletion Worksheet
o STCL-PROC-038 FRM2 Certificate of Analysis for CD45RA+ Depleted Donor Lymphocytes Infusion
o STCL-PROC-038 JA1 Checklist for Depletion Tubing Set-DTS
o STCL-PROC-038 JA2 Depletion Tubing Set Diagram
o STCL-PROC-038 JA3 Separation Planner V2.40
o STCL-PROC-040 BioArchive System
o STCL-PROC-042 UCB Processing Using the Sepax 2 S-100 Cell Processing System with UCB-HES Protocol
o STCL-PROC-042 FRM2 UCB Processing Worksheet
o STCL-PROC-044 CBU Processing via Manual Method
o STCL-PROC-044 JA1 Growth Charts for Girls and Boys
o STCL-PROC-045 Cryopreservation and Storage of CBU
o STCL-PROC-045 FRM1 CBU Cryopreservation
o STCL-PROC-046 Processing Bone Marrow Using the Sepax 2 Instrument
o STCL-PROC-046 JA1 Sepax 2 Product Data Sheet CS-490.1
o STCL-PROC-046 JA2 Sepax 2 Guidelines-BM Processing, RBC and Plasma Depletion
o STCL-PROC-046 JA3 Sepax 2 Guidelines-BM Processing Plasma Depletion ONLY
o STCL-PROC-047 CliniMACS TCR alpha beta+ T-Cell / CD19+ B-Cell Reduction Procedure
o STCL-PROC-047 FRM1 CliniMACS TCR alpha beta+ T-Cell / CD19+ B-Cell Reduction Worksheet
o STCL-PROC-047 FRM2 CliniMACS TCR alpha beta+ T-CELL - CD19+ B-CELL C of A
o STCL-PROC-047 JA1 Installation of CliniMACS DTS Tubing Set
o STCL-PROC-047 JA2 CSIDE Clinical Protocol v2.0
o STCL-PROC-047 JA3 CSIDE MOP v2.0
o STCL-SOP-022 Viability Counts via Trypan Blue Dye Exclusion
o STCL-SOP-022 FRM1 Trypan Blue Stain Quality Control
o STCL-SOP-028 JA1 Thawing Job Aide
o STCL-SOP-028 JA2 Dextran Albumin Thawing Vials and Small Cryobags
o STCL-SOP-028 JA3 Thawing Human-CT-derived Mesenchymal Stem Cells (MSCs) for Infusion
o STCL-SOP-028 JA4 Thawing Human Cord Tissue-derived MSCs for Infusion-IMPACT Study
o STCL-SOP-030
FRM1 STCL ISBT Barcode Label Release Log
o STCL-SOP-030
FRM2 ISBT Barcode Label Reconciliation Log
o STCL-SOP-030
FRM3 ISBT Barcode Label Receipt Log
o STCL-SOP-030
FRM4 ISBT Barcode Label Destruction Log
o STCL-SOP-030
JA1 Receiving, Reconciliation, and Destruction of ISBT Barcode Labels
o STCL-SOP-032 Responsibility of Facility Directors
o STCL-SOP-034 Instructions for Tests in External Reference Labs
o STCL-SOP-035 Cleaning and Decontamination Protocol for STCL
o STCL-SOP-035 FRM1 Quarantine and Decontamination Log
o STCL-SOP-037 Unacceptable Specimen Log
o STCL-SOP-038 Confirmation of Specimen Identification Form
o STCL-SOP-039 Scheduling Collection, Infusion, and Processing Procedures and Obtaining Orders
o STCL-SOP-045 Disposing of Unused-Outdated Cryopreserved Recipient Products
o STCL-SOP-045 FRM1 Record of Discard
o STCL-SOP-049 FRM1 Blood Bank Worksheet
o STCL-SOP-049 FRM2 ABO Rh Confirmatory Typing Request Form
o STCL-SOP-049 JA1 AB Serum Test (AB Control)
o STCL-SOP-049 JA2 Performing Daily Control of ABO/Rh Reagents
o STCL-SOP-049 JA3 Calibration of Fixed Speed Centrifuges
o STCL-SOP-053 Reagent Grade Water
o STCL-SOP-053 FRM1 DI Water Check
o STCL-SOP-054 Cleaning and Decontamination of STCL by External Vendor
o STCL-SOP-054 FRM1 STCL Contracted Cleaning Services Checklist
o STCL-SOP-056 FRM1 OOS - Colony Forming Unit Assay
o STCL-SOP-056 JA1 Operation of STEMvision™ Automated Colony-Forming Cell Assay Analyzer
o STCL-SOP-056 JA2 STEMvision™ Automated Colony-Forming Unit (CFU) Assay Reader Technical Manual
o STCL-SOP-056 JA3 Flow Diagram for Processing Fresh Cord Blood Samples Using STEMvision™ Analyzer
o STCL-SOP-056 JA4 STEMvision™ Instrument Quick Guide
STCL-Selection, Release and Shipment
STCL-Flow Cytometry
o FLOW-FORM-001 Adult Allogeneic Donor PSC Lymphocyte Subset Results
o FLOW-FORM-003 Flow Cytometry Results
o
FLOW-FORM-004
Adult PSC CD34 Selection Product Lymphocyte Subset Results
o
FLOW-FORM-004
JA1 Adult PSC CD34 Selection Product Lymphocyte Subset Results
o
FLOW-FORM-005
Immune Reconstitution
o FLOW-FORM-006 BD FACSCalibur Flow Cytometer Maintenance Log
o FLOW-FORM-007 BD FACSCalibur Flow Cytometer Instrument QC Log
o FLOW-FORM-008 Flow Cytometry Process Control Record Sheet
o FLOW-FORM-011 BD FACS CANTO II Maintenance Log
o FLOW-FORM-012 Graft Characterization
o FLOW-GEN-001 Routine Maintenance of BD FACSCalibur Flow Cytometers
o FLOW-GEN-007 Lyse No Wash Staining for Flow Cytometry
o FLOW-GEN-007 JA1 Immune Reconstitution Alternate Performance Assessment Process
o FLOW-GEN-007 JA2 CAR T-Cell Testing Protocols
o FLOW-GEN-012 FRM5 Stem Cell Laboratory Flow Cytometry Worksheet
o FLOW-GEN-013 Using R&D Systems Status Flow Process Controls
o FLOW-GEN-014 Quality Control for BD FACSCalibur Flow Cytometer
o FLOW-GEN-020 Stem Cell Laboratory Quality Management-Quality Control Policies for Flow Cytometry
o FLOW-GEN-021 Archiving Flow Cytometry Data
o FLOW-GEN-023 Specimen Dilution Protocol (JA1)
o FLOW-GEN-025 Flow Cytometry Staining and Analysis - 7-AAD Method
o FLOW-GEN-032 Fluorescence Overlap Compensation Optimization for the BD FACSCalibur Flow Cytometer
o FLOW-GEN-041 BD FACSCanto II Maintenance
o FLOW-GEN-041 JA1 FACSCanto II Instrument Startup
o FLOW-GEN-042 Using the CBC Monitor Data Entry System
o FLOW-GEN-043 Flow Cytometric Analysis of CD45RA+ Cell Depletion Test Samples
o FLOW-GEN-044 Performance Verification of Un-assayed Antibodies
o FLOW-GEN-044 FRM1 Un-assayed Antibodies Record Sheet
o FLOW-GEN-049 JA4 Color Compensation Settings for BD FACSCanto II
STCL-HPCA
o
STCL-EQUIP-012
WESCOR 7120 Aero Spray Hematology Strainer
o
STCL-EQUIP-012
FRM1 Wescor Hematology Slide Stainer Maintenance Log
o
STCL-PROC-022
Hematopoietic Progenitor Cell Assay (HPCA) - Fresh and Thawed Clinical Products
o
STCL-PROC-022
FRM2 Media Lot-to-Lot QA Release Log
o
STCL-PROC-022
FRM3 Reagent Verification Log
o
STCL-PROC-022
FRM4 HPCA Quarterly Competency Assessment
o STCL-PROC-022 FRM5 HPCA Repeat Analysis
o STCL-PROC-022 FRM6 HPCA Specimen Logsheet
o STCL-PROC-022 FRM7 Hematopoietic Progenitor Cell Assay (HPCA) Worksheet for NMDP Biobank Samples
o
STCL-PROC-022 JA1 Tech Manual – Human Colony-Forming Unit (CFU)
Assays using MethoCult
o
STCL-PROC-022
JA2 Separation of Cells Using a Ficol-gradient
o
STCL-PROC-022
JA3 Thawing of Frozen Products for HPCA Testing
o
STCL-PROC-024 Coverslip
Preparation
o
STCL-PROC-035
Manual Cell Differential (Slide Method), CBU's for CCBB Program
o
STCL-PROC-035
FRM1 Manual Differential Cord Blood Units
o STCL-SOP-052 Hematopoietic Progenitor Cell Assay (HPCA) Cord Blood Bank Products
o
STCL-SOP-052
FRM1 Progenitor Cell Assay Form
o
STCL-SOP-052 FRM2 Hematopoietic Progenitor Cell (HPCA) CCBB Samples Repeat Analysis
o
STCL-SOP-052
JA1 HPC Processing of Fresh UCB Samples – Flow Chart
o
STCL-SOP-052
JA2 Medium Lot to Lot Testing
o
STCL-SOP-059
FRM1 6-Well SmartDish HPCA Worksheet
STCL-General
o OC-007 STCL Organizational Chart
o STCL-COLL-007 Autologous and Directed CBU Donations
o STCL-COLL-007 FRM1 Autologous and Directed Collection and Processing Order Form
o STCL-COLL-007 FRM2 Auto-Directed CBU Receipt Form
o STCL-COLL-007 FRM3 Auto-Directed CBU Product Summary Report
o STCL-COLL-007 FRM4 Auto-Directed CBU Collection Bag Label
o STCL-COLL-007 FRM6 Billing and Claim Process Letter
o STCL-COLL-007 FRM7 Blue Box Insulated Shipper Inspection and Cleaning Log
o STCL-COLL-007 JA1 Agreement for Directed Donation and Storage of Umbilical Cord Blood
o STCL-COLL-007 JA3 Collection of Autologous Directed CBU
o STCL-COLL-007 JA4 Letter for CBU Results
o STCL-COLL-007 JA5 Letter to Collecting MD
o STCL-COLL-007 JA6 Assembly of Collection Kits for Autologous-Directed Donations
o STCL-COLL-007 JA7 Packing and Shipping Diagram
o STCL-COLL-007 JA8 Blue Box Instruction Checklists
o STCL-COLL-007 JA9 Managing Data Loggers for CBU Shipments
o STCL-COLL-007 JA10 Auto/Directed Maternal Blood Sample Processing
o STCL-COLL-007 JA11 Blue Box Insulated Shipper Inspection and Cleaning
o STCL-EQUIP-013 JA1 Refrigeration Call List
o
STCL-GEN-002 STCL Supply Management Procedure
o STCL-GEN-002 FRM1 Supply Ordering Log
o STCL-GEN-002 FRM2 STCL Supply Receipt Log
o
STCL-GEN-002 FRM3
Unacceptable Supply Product Recall Corrective Action Log
o STCL-GEN-002 FRM4 Package Insert Review Log
o STCL-GEN-002 FRM5 STCL Material Specification Form
o STCL-GEN-002 JA1 Certificates of Analysis and/or Certificates of Conformance
o STCL-GEN-002 JA2 Storage of Supplies in Designated Areas of the STCL
o STCL-GEN-008 Stem Cell Laboratory Disaster Plan
o STCL-GEN-009 Packaging and Transporting Non-Frozen Cellular Products Locally
o STCL-GEN-009 FRM1 Cellular Product Chain of Custody
o STCL-GEN-009 FRM2 Cellular Product-Sample Chain of Custody
o STCL-GEN-009 FRM3 Cellular Product Chain of Custody Form for Products Collected Outside NP
o STCL-GEN-012 FRM1 STCL New Laboratory Employee On-Site Safety Training Checklist
o STCL-GEN-012 JA1 Site Specific Fire Plan for Stem Cell Laboratory Plan I
o STCL-GEN-012 JA2 OESO Site Specific Fire Plan Duke Hospital Plan II
o STCL-GEN-012 JA3 Biological Safety - Biosafety Levels
o STCL-GEN-013 Procedure Verification for STCL
o STCL-GEN-013 FRM1 Procedure Verification for STCL
o STCL-GEN-014 Product Safety - Minimizing Cross-Contamination
o
STCL-GEN-015 Records
Management
o
STCL-GEN-015
JA1 EMMES System Advantage EDCSM
o STCL-GEN-015 JA2 Duke Stem Cell Laboratory System Advantage EDC-SM User's Guide
o STCL-GEN-015 JA3 Disposition of Labels, Barcodes and Ribbons
o STCL-GEN-017 Stem Cell Laboratory Overview
o STCL-GEN-017 JA1 Assessment of Stem Cell Laboratory Facility Parameters
o STCL-GEN-018 Quality Control Systems for the STCL
o STCL-GEN-019 Corrected Results - Monitoring, Reporting and Remediation
o STCL-QA-005 Review of Processing Records
o STCL-QA-005 FRM1 Apheresis Record Checklist
o STCL-QA-005 FRM2 Infusion Record Checklist
o STCL-QA-005 FRM3 Selection Record Checklist
o STCL-QA-005 FRM4 Bone Marrow Harvest Record Checklist
o STCL-QA-006 Stem Cell Laboratory Quality Management Plan
o STCL-QA-007 Non-Conforming Products - Receipt, Processing, Distribution, and Disposition
o STCL-QA-007 FRM1 Non-Conforming Products
o STCL-QA-008 Stability Assessment of Clinical Products
o STCL-QA-008 JA1 EMMES Stability Data Integrity Verification
o STCL-SOP-033 Stem Cell Laboratory Personnel
o STCL-SOP-043 Receipt of Products in the STCL
o STCL-SOP-058 Laboratory Test Ordering
o STCL-SOP-058 JA1 Ordering STCL Test in EPIC Beaker - Open Encounter
o STCL-SOP-058 JA2 Ordering STCL Test in EPIC Beaker - Closed Encounter
o STCL-SOP-058 JA3 Entering Test Results in EPIC Beaker
o STCL-SOP-058 JA4 Maestro Care Quick Start Guide Beaker Clinical Pathology
o
STCL-TRN-001 Training in the Stem Cell Laboratory
o
STCL-TRN-001
FRM1 Individual Training Plan
o
STCL-TRN-001
FRM2 Competency Assessment Form
o
STCL-TRN-001
FRM3 Group Review Log Sheet
o
STCL-TRN-001 FRM4 Stem Cell Laboratory Medical Director Competency Checklist
STCL-Forms
o STCL-FORM-001 Liquid LN2 Freezer Bulk Tank Level and Pressure
o STCL-FORM-002 Heracell CO2 Incubator Daily Weekly
o STCL-FORM-003 Balances Daily QC and Monthly Maintenance
o STCL-FORM-004 Freezer Daily Temperature Log
o STCL-FORM-005 Fire Extinguisher Weekly Maintenance
o STCL-FORM-006 BacT Alert Daily Temperature Log
o STCL-FORM-007 Liquid LN2 Freezer Daily QC Record
o STCL-FORM-008 Microscopes Daily Weekly QC Log
o STCL-FORM-009 Sealer Maintenance Log
o STCL-FORM-011 Eye Wash Continuous Flow Function Verification
o STCL-FORM-014 Water Bath Temperature and Maintenance Log
o STCL-FORM-018 Sterile Docker Daily QC and Maintenance Log
o STCL-FORM-019 Trouble Shooting Log
o STCL-FORM-020 Barcode Printer Maintenance-Daily Monthly
o STCL-FORM-021 VAPOR LN2 Freezer Daily QC Record
o STCL-FORM-022 Centrifuge Bi-Annual Verification of Function
o STCL-FORM-023 Refrigerator Daily Temperature Log
o STCL-FORM-024 Blood Bank Refrigerator Daily, Weekly, Monthly Maintenance
o STCL-FORM-025 Work Surface Decontamination
o STCL-FORM-026 Centrifuge Daily Weekly Monthly QC Log
o STCL-FORM-027 Maintenance Cleaning Schedule for Stem Cell Laboratory
o STCL-FORM-029 Out of Service
o STCL-FORM-030 CAP Survey Review
o STCL-FORM-031 SCT Proficiency Survey Review
o STCL-FORM-033 Refrigerated (Sorvall RC-3) Centrifuge Daily-Weekly-Monthly QC Log
o STCL-FORM-034 Data Verification Form
o STCL-FORM-035 Thermogenesis Bio-Archive Freezer Daily, Bi-Weekly, Monthly Maintenance and QC Schedule
o STCL-FORM-036 Biological Safety Cabinet with Vacuum Trap and Paper Catch - Daily, Weekly, Monthly Maintenance Schedule
o STCL-FORM-037 Bone Marrow Harvest Quality Assurance Sheet
o STCL-FORM-038 -80 C Freezer Log
o STCL-FORM-040 Peripheral Blood Progenitor Cell Worksheet Adult
o STCL-FORM-041 Doctors Orders Adult Stem Cell Transplant Program
o STCL-FORM-042 Cellular Product Distribution Form for Cooler
o STCL-FORM-043 Thawing and Infusion Worksheet
o STCL-FORM-044 Processing Lot Numbers -37 Degree Celsius Thaws
o STCL-FORM-045 Processing Lot Numbers - Bone Marrow Processing,
o STCL-FORM-046 Processing Lot Numbers - Bone Marrow or PSC DA Thaw
o STCL-FORM-047 Processing Lot Numbers - UCB DA Thaw
o STCL-FORM-048 Processing Lot Numbers - Granulocyte Processing
o STCL-FORM-049 Processing Lot Numbers - Incoming Cellular Product Processing
o STCL-FORM-050 Processing Lot Numbers - CBU Processing
o STCL-FORM-051 Processing Lot Numbers - UCB Supernatant Cryopreservation
o STCL-FORM-054 LN2 Freezer Vial Storage Grid
o STCL-FORM-055 Control Rate Freezer Canister and Vial Storage Log
o STCL-FORM-056 Cellular Therapy Infusion Request Form
o STCL-FORM-057 Packing Information
o STCL-FORM-058 Receipt of Cellular Products
o STCL-FORM-059 Cellular Product Summary
o STCL-FORM-060 Inter-institutional Physician's Agreement Request to Transfer Patient Product
o STCL-FORM-061 Checklist for Shipping Cryopreserved Cellular Products from STCL
o STCL-FORM-062 Stem Cell Laboratory Processing Order Form
o STCL-FORM-063 Confirmation of Cell Dose for Infusion
o STCL-FORM-064 Manual Differential Worksheet - Clinical Products
o STCL-FORM-065 Bone Marrow Harvest Worksheet
o STCL-FORM-066 UCB Thaw (Infusion)
o STCL-FORM-067 UCB QC Aliquot
o STCL-FORM-068 Cleaning Schedule for Transport Containers in the STCL
o STCL-FORM-069 CO2 Incubators Quarterly Maintenance Log
o STCL-FORM-070 STCL Pipet Usage for HPCA
o STCL-FORM-071 Certificate of Analysis for MSC, Umbilical Cord - Post Thaw
o STCL-FORM-073 CO2 Incubator Plate Inspection Log
o STCL-FORM-074 Processing Lot Numbers - MSC Thaws
o STCL-FORM-075 Circular of Information for the Use of Cellular Therapy Products
o STCL-FORM-076 BacT ALERT Monthly Quality Control Log