A siaCORD
International Standards for Cord Blood
Collection, Processing, Testing, Banking,Selection and Release

First Edition November, 2001

International Standards for Cord Blood Collection,
Processing, Testing, Banking, Selection and Release
AsiaCORD
November, 2001

Introduction
These Standards based on NETCORD/ FACHT standards (2nd version) were adopted byconsensus by representatives of AsiaCORD. They were adopted by the Boards of AsiaCORD
after a period of public comment. They were revised November 1, 2001 and are effective June,
2002. AsiaCORD is responsible for the acts or omissions of the other.

NoticeThese Standards are designed to provide minimum guidelines for facilities and individuals
performing cord blood collection, processing, testing, banking, selection and release orproviding support service for such procedures. These Standards are not intended to include allprocedures and practices that a Cord Blood Bank or individual should implement if thestandard of practice in the community or federal or state laws or regulations establish
additional requirements. Each Cord Blood Bank and individual should analyze its practices
and procedures to determine whether additional standards apply. AsiaCORD disclaim any
responsibility for setting maximum standards and expressly do not represent or warrant thatcompliance with these Standards is an exclusive means of complying with the standard ofcare in the industry or community.

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Table of Contents

Part APart B

Part CTERMINOLOGY, ABBREVIATIONS AND DEFINITIONS
A1.000Terminology

A2.000Abbreviations

A3.000Definitions

CORD BLOOD BANK STANDARDS
B1.000Definition of a Cord Blood Bank

B2.000Cord Blood Bank Facility Requirements

B3.000Cord Blood Bank Safety Requirements

B4.000Cord Blood Bank Personal Requirements

B5.000Quality Management Requirements

B6.000Institutional Review Board Requirements

B7.000Identification and Labeling Requirements

B8.000

Supplies, Reagents and Equipment Requirements

B9.000Records Requirements

CORD BLOOD DONOR AND COLLECTION STANDARDS
C1.000

Donor Evaluation

C2.000Informed Consent

C3.000Cord Blood Collection Facilities

C4.000Cord Blood Collection Procedures

C5.000Transplantation of Non-Cryopreserved Cord Blood Units Between Cord
Blood Collection Site/Facility and the Cord Blood Processing Laboratory

Part D

8

CORD BLOOD PROCESSING STANDARDS
D1.000General Requirements

D2.000Cord Blood Processing

D3.000

Review of Processing Records

D4.000

Reference Samples

D5.000Label at Completion of Processing

D6.000Cryopreservation
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D7.000Conditions for Storage

D8.000

DisposalD9.000Quality Management

SELECTION, RELEASE AND SHIPPING OF CORD BLOO UNITS
E1.000General Requirements for Unrelated Allogeneic Cord Blood Units

E2.000General Requirements for Related Allogeneic and Autogeneic Cord Blood
Transplantation

E3.000Cord Blood Selection for Unrelated or Related Allogeneic Cord Blood
Transplantation

E4.000Cord Blood Selection for Autologous Cord Blood Transplantation

E5.000Cord Blood Unit Release

E6.000Transport of Cryopreserved Unit from the Cord Blood Bank to theTransplant Facility

E7.000Transport Records

E8.000

Clinical Outcome Data

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Part A:TERMINOLOGY, ABBREVIATIONS AND DEFINITIONS

A1.000Terminology
For purposes of these Standards, the terms shall, will, or must mean that theStandard is to be complied with at all times. The terms may and should indicate an
activity that is recommended or advised, but for which there may be effective
alternatives.

A2.000Abbreviations
The following abbreviations and definitions are used these Cord Blood Standards;
ABO

Major human blood group system.

Ag

Antigen.

Anti-

An antibody to the antigen designated.

ASHI

American Society for Histcompatibility and Immunogenetics.

°C

degree centigrade.

CB

Cord BloodCBB

Cord Blood Bank

CMV

CytomegalovirusDNA

Deoxyribonucleic acid

EBV

Epstein-Barr virus.

FAHCT Foundation for the Accreditation of Hematopoietic Cell Therapy.
GVHD

Graft-vs-host disease.

HLA

Human Leukocyte Antigen, the major histocompatibility system inhumans.

A3.00010

HBc

Hepatitis B core antigen.

HBsAg

Hepatitis B surface antigen.

HBV

Hepatitis B virus.

HCV

Hepatitis C virus

HIV

Human immunodeficiency virus.

HTLV

Human T cell lymphotropic virus.

QM

Quality Management.

Rh

Rhesus system of human red blood cell types.

Definitions
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Adventitious refers to extraneous microbiological, chemical, or radiobiologicalagents introduced into the CB unit during collection, processing, or infusion.
Allogeneic refers to CB cells obtained from one donor and intended for infusion
into another individual.
Unrelated allogeneic refers to CB cells collected and stored for use by
biologically unrelated individuals.
Related allogeneic refers to CB cells collected and stored for use by an
identified individual or family that is biologically linked to the cord blood
donor.
Autologous refers to CB cells obtained from a donor and intended for infusion intothat same individual.
CD34 refers to the 115kD glycoprotein antigen, expressed by 1-2% of normal bonemarrow mononuclear cells, that is defined by a specific monoclonal antibody(anti-CD34) using the standardized cluster of differentiation (CD) terminology. The
vast majority of CB progenitors, including those cells that give rise tohematopoietic colonies in vitro, are contained in the population of cells expressing
the CD34 antigen.
CFU refers to colony forming unit, a clonogeneic cell able to produce colonies invitro under specific conditions in the presence of appropriate colony stimulating
factors and defined by the type of mature progeny that develop.
Collection Facility refers to the site where the infant is delivered and the CB units iscollected.
Component refers to CB that is being processed, at any stage of the processing.
Computer system is the hardware, software, peripheral devices, personnel anddocumentation involved in production of an electronic record.

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Contiguous segments are sealed lengths of tubing integrally attached to the CB unitthat contain cord blood used for testing.
Cord Blood refers to the whole blood including hematopoietic progenitor cells
collected from placental and umbilical cord blood vessels after the umbilical cordhas been clamped.
Cord Blood Bank consists of an integrated program under a single Director
responsible for the collection, processing, testing, banking, selection and release of
CB for clinical use.
Cord Blood Collection is the procurement of CB for banking and transplantation
before and/or after the placenta is delivered.
Ex utero refers to collection of CB cells from the placental umbilicalvessels after the placenta has been delivered.
In utero refers to CB cells that are collected from the placental umbilicalvessels after the infant has been delivered and separated from theumbilical cord, but before the placenta has been delivered.
Cord Blood cryopreserved is CB that has been frozen using devices, supplies, andtechniques validated for that purpose.
Cord Blood Standards refers to this document, “International Standards for Cord
Blood Collection, Processing, Testing, Banking, Selection and Release.”
Cord Blood Unit is the nucleated cells including stem and hematopoietic progenitor
cells harvested from placental and umbilical cord blood vessels from a single
placenta after the umbilical cord has been clamped. Unless otherwise specified, theterm CB unit in this document refers to all CB units regardless of method ofcollection or intended use.
Cord Blood Unit Unrelated Allogeneic refers to a CB unit obtained fromone donor and intended for infusion into another individual who is not

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biologically related to the donor.
Cord Blood Unit Related Allogeneic refers to a CB unit that is intended
for infusion into another individual who is biologically related to thedonor.
Cord Blood Unit Autologous refers to a CB unit that is obtained from adonor and intended for infusion into that same individual.
Depletion is the manipulation of CB that results in the loss of specific targeted cell
population(s) using validated techniques.
Director-For purposes of these Standards there are three categories of Director:
CBB Director is an individual with an earned doctoral degree in medicine,or in a related scientific field, with postdoctoral training in
immunogenetics of transplantation, basic or clinical immunology,
immunohematology, blood or tissue banking, or cryobiology. The CBB
Director has final responsibility for the CBB scientific and clinicalperformance and its overall compliance with these Standards. The CBB
Director should participate regularly in educational activities related to
the field of hematopoietic progenitor cell collection, processing,transplantation and/or CB banking.
CBB Medical Director is a licensed physician with postdoctoral training
in hematopoietic cell transplantation or blood and tissue banking. This
individual is directly responsible for the medical aspects of the collection
procedures and compliance of the collection facilities with theseStandards. Where there are remote collection facilities shipping CB cells
to a central laboratory, the CBB Medical Director, and need not belicensed in the jurisdiction of the collection or be on the staff of thecollection facility. The CBB Medical Director may also serve as the CBB
Director and/or CBB Laboratory Director should if appropriately
credentialed. The CBB Medical Director should participate regularly in
educational activities related to the field of hematopoietic progenitor cell
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collection, processing, transplantation and/or CB banking.
CBB Laboratory Director is an individual with a relevant doctoral degree,
qualified by postdoctoral training or experience for the scope of activities
carried out in the CB processing facility. The CBB Laboratory Director is
responsible for all procedures and administrative operations of theprocessing facility, including compliance with these Standards. The CBBLaboratory Director may also serve as the CBB Director and/or CBB
Medical Director if appropriately credentialed. The CBB Laboratory
Director should participate regularly in educational activities related to
the field of hematopoietic progenitor cell collection, processing,transplantation and/or CB banking.
Donor is the infant from whose placenta the CB is obtained.
Directed donor refers to an infant whose CB is collected and stored foruse by an identified individual or family. Directed donors could be related
allogeneic or autologous donors.
Electronic record is any record or document consisting of any combination of text
or graphics or other data that is crested, stored, modified, or transmitted in digitalform by a computer.
Engraftment is the reconstitution of recipient hematopoiesis with white blood cells,
red blood cells and platelets from the donor.
Expansion refers to growth of one or more populations of CB cells in vitro in a
culture system.
FAHCT Standards refers to the current North American edition of Standards for
Hematopoietic Progenitor Cell Collection, Processing & Transplantation publishedby FAHCT.
Gene Manipulation refers to the insertion of nucleic acid constructs into one ormore populations of CB cells for the purpose of altering the genetic structure orfunction transiently or permanently.

14

AsiaCORDHematopoietic Progenitor Cells include primitive pluripotent hematopoietic cells in
the CB capable of self-renewal as well as maturation into any of the hematopoietic
lineages, including committed and lineage-restricted progenitor cells, unlessotherwise specified, regardless of tissue source.
Institutional Review Board refers to a Board established by an institution inaccordance with the regulations of the United States Department of Health andHuman Services or other governmental agency if applicable, to review biomedical
and behavioral research involving human subjects conducted at or supported by that
institution.
Labeling includes steps taken to identify the original hematopoietic progenitor cellcollection, any components, and any component modification; to complete therequired reviews; and to attach the appropriate labels.
Linkage is the basic demographic information including name, that would allow
identification of the CB donor and/or mother.
Manipulation refers to an ex vivo procedure(s) that selectively removes, enriches,
expands or functionally alters hematopoietic progenitor cells.
Minimally Manipulated for the purposes of these Standards refers to theremoval of red cells and/or volume reduction of a CB unit.
Microbial refers to infectious agents including bacterial and fungal organisms.
Mother. Any of the following:
Biological mother.

The woman from whose egg the infant donor
develops; the egg donor.

Birth mother.

The woman who carries the infant to its delivery;
may be the biologic mother or a surrogate mother.

Surrogate mother.

A woman who carries an infant from an egg(ovum)
not biologically hers. Under circumstances of asurrogate mother carrying the infant to term and the
CB unit being collected, both the surrogate and the
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biologic mother shall be considered for purposes ofinfectious disease screening and testing; thebiologic mother shall be considered for purposes ofgenetic information.
When used unmodified, the term mother is intended to include all of theabove individuals.
AsiaCORD is the international organization of CB banks that meet defined
membership requirements of AsiaCORD.
Nonconforming Unit is any CB unit that does not completely meet the requirements
specified by these Standards.
Positive selection is the manipulation of CB such that a specific cell population(s) isenriched.
Processing includes all aspects of manipulation, cryopreservation and labeling of
the CB.
Proficiency Test measures laboratories’ abilities to analyze specimens of unknown
values and obtain accurate results within acceptable ranges.
Quality refers to conformance of a product or process to pre-establishedspecifications or standards.
Quality Assurance describes the actions, planned and performed, to provide
confidence that all systems and elements that influence the quality of the productare working as expected individually and collectively.
Quality Assessment describes the actions, planned and performed, to evaluate allsystems and elements that influence the quality of the product or service.
Quality Control refers to a component of a quality program that includes theactivities and controls used to determine the accuracy and reliability of theestablishment’s

16

personnel,

equipment,
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reagents,

andoperations

in

the

manufacturing of hematopoietic progenitor cell components, including testing andproduct release.
Quality Improvement describes the actions planned and performed to develop asystem to review and improve the quality of a product or process.
Quality Management refers to an integrated program of quality assessment,
assurance, control and improvement.
Quality Management Supervisor is a qualified individual designated by the CBB
Director, to establish methods to review, modify, approve and implement allprocedures intended to maintain quality in the operation of the CBB, and to monitor
compliance with these CB Standards.
Quarantine storage is storage of CB in a physically separate area clearly identified
for such use, or using other procedures, such as automated designation to prevent
improper release before infectious disease testing results are reviewed.
Reference samples are aliquots of cells, plasma, serum, or cellular material from the
CB unit or blood from the mother that are used to confirm the identity, HLA typing,or genetic or transmissible disease information associated with a single CB unit.
Such samples may or may not be contiguous segments.
Rh the abbreviation for the Rhesus system of human red cell antigens, is used in thisdocument to refer to the Rh(D) antigen only unless otherwise specified.
Safety refers to relative freedom from harmful effects to persons affected, directly or
indirectly, by a product when prudently administered, taking into consideration thecharacter or the product in relation to the condition of the recipient at the time.
Selection refers to the dynamic process of identification of a CB unit fortransplantation that meets recipient-defined criteria.
Standard Operating Procedures Manual refers to a complication of written detailed
instructions required to perform procedures.
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Transplantation refers to the infusion of allogeneic or autologous CB progenitor
cells with the intent of providing transient or autologous CB progenitor cells with
the intent of providing transient or permanent engraftment.
Volume reduction is the manipulation of the CB unit that results in loss of CB
volume without significant loss of nucleated cells.
Validation refers to establishing documented evidence that provides a high degreeof assurance that a specific process will consistently produce a CB unit meeting its
predetermined specifications and quality attributes. A process is validated toevaluate the performance of a system with regard to its effectiveness based on
intended use.

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AsiaCORDPart B

CORD BLOOD BANK STNDARDS

B1.000

DEFINITION OF A CORD BLOOD BANKThe Cord Blood Bank (CBB) consists of an integrated team responsible for thecollection, processing, testing, banking, selection and release of CB cells forallogeneic and/or autologous hematopoietic progenitor cell transplantation. The
CBB shall have a defined managerial structure, under a single Director withadequate staff and facilities, and written policies and protocols for all procedures
performed by the CBB including staff training, competency and quality
management.

B1.100A CBB that includes multiple collection sites shall employ common
protocols, staff training and competency evaluation procedures, quality
assessment systems, and shall demonstrate evidence of regular interaction
between these sites and the bank.

B1.200

The CBB and each collection site shall meet the AsiaCORD Standards forcollection, processing, testing, banking, selection and release of CB units
for clinical use.

B1.300

The CBB shall operate in compliance with local and national licensing
requirements,

these

standards

and

all

applicablegovernmental

regulations.

B2.000

CORD BLOOD BANK FACILITY REQUIREMENTS

B2.100

These shall be designated facilities with adequate space for records;
laboratory procedures; and preparation and safe, sanitary and orderly
storage of the reagents and equipment needed for CB collection,
processing, testing, banking, selection and release.

B2.200

The CBB shall be secure to prevent the admittance of unauthorized
personal.

B2.300

The CBB shall utilize a Human Leukocyte Antigen (HLA) testinglaboratory accredited by equivalent accrediting organization of eachcountry.

B2.400

The CBB shall utilize a laboratory(ies) to perform all other tests required
for evaluation of the mother or CB unit. The laboratory(ies) shall beaccredited, certified or licensed to perform such testing in accordance
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with governmental regulations.

B3.000

CORD BLOOD BANK SAFETY REQUIREMENTS

B3.100

The CBB shall have in operation programs designed to minimize risks to
the health and safety of employees, donors, volunteers, and patients andshall operate in compliance with all applicable governmental safety
regulations.

B3.200

The CBB shall have written policies and procedures for infection control,
biosafety, chemical and radiation safety, emergency response to worksite
accidents, and waste disposal, as appropriate.

B3.300

The CBB shall have written policies and procedures for action in case of
exposure to communicable disease, or to chemical, biological orradiological hazards.

B3.400Decontamination and disposal techniques for medical waste shall be
described. Human tissue shall be disposed in such a manner as tominimize hazard to facility personnel and the environment.

B4.000

CORD BLOOD BANK PERSONNEL REQUIREMENTS

B4.100

The CBB shall maintain a written description of its organizational
structure.

B4.200

There shall be a CBB Director who has final responsibility for the CBBscientific and clinical performance and its overall compliance with theseStandards. The CBB Director shall have earned a doctoral degree inmedicine, or in a related scientific field, with postdoctoral training in
immunogenetics of transplantation, basic or clinical immunology,
immunohematology, blood or tissue banking or cryobiology. The CBB
Director should participate regularly in educational activities related to
the field of hematopoietic progenitor cell collection, processing,transplantation and/or CB banking.

B4.300

There shall be a CBB Medical Director who is a licensed physician withpostdoctoral training in hematopoietic cell transplantation of blood andtissue banking. This individual is directly responsible for the medical
aspects of the collection procedures and compliance of the collection
facilities with these Standards. The CBB Medical Director should

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participate regularly in educational activities related to the field ofhematopoietic progenitor cell collection, processing, transplantation
and/or CB banking.
B4.310

Where there are remote collection facilities shipping CB cells to acentral laboratory, the CBB Medical Director may serve thefunction of that remote collection facility Medical Director, andneed not be licensed in the jurisdiction of the collection or be on
the staff of the collection facility.

B4.320

The CBB Medical Director may also serve the CBB Director
and/or CBB Laboratory Director if appropriately credentialed.

B4.400

There shall be a CBB Laboratory Director who is an individual with arelevant doctoral degree, qualified by postdoctoral training or experience
for the scope of activities carried out in the CB processing facility. The
CBB Laboratory Director is responsible for all procedures andadministrative operations of the processing facility, including compliancewith these Standards. The CBB Laboratory Director should participate
regularly in educational activities related to the field of hematopoetic
progenitor cell collection, processing, transplantation and/or CB banking.
B4.410

The CBB Laboratory Director may also serve as the CBB Director
and/or CBB Medical Director if appropriately credentialed.

B4.500

There shall be a CBB Quality Management Supervisor designated by the
CBB Director, to establish and maintain systems to review, modify asnecessary, approve and implement all procedures intended to monitor
compliance with these Standards and/or the performance of the facility.
The CBB Quality Management Supervisor should participate regularly in
educational activities related to the field of hematopoietic celltransplantation and/or CB banking quality management.

B4.600

The CBB shall have adequate staff whose training, continuing education,and continued competency for the performance of all operations shall be
documented.

B5.000QUALITY MANAGEMENT REQUIREMENTS
The CBB shall establish and maintain a program of quality assessment andimprovement. The quality program shall cover all aspects of CB collection,
processing, testing, banking, selection and release.
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B5.100

Policies And Procedures
B5.110

The CBB shall have clearly written policies and procedures, that
address all aspects of the operation. These shall be appropriately
titled and follow a common format and system of numbering.
Work instructions shall be precise and unambiguous and include
the objective addressed; personal responsible for its execution; thefacility, equipment, and supplies required; and the expected rangeof results. Where appropriate, there shall also be examples ofcorrectly completed worksheets, forms and reports, scientific ortechnical references and the results of validation studies.
Here shall be policies and procedures to cover at least thefollowing CBB operations:
B5.111

Preparation, approval, implementation and modification ofstandard operating procedures.

B5.112

Maternal screening and consent.

B5.113

CB collection and transport to processing laboratory.

B5.114

CB processing, cryopreservation, storage and expiration
dates.

B5.115Labeling.

B5.116

Infectious disease, immunogenetic typing, and othertesting.

B5.117

Notification of mother or their responsible physicians ofpositive or indeterminate test results according to local or
national regulations.

B5.118

Criteria for release of CB units including non-conforming
units, formal issuing of CB units, and shipping of CB units
to Transplant Centers.

B5.119Quality

management

includingqualityassessment,

improvement and corrective actions, and errors andaccident reporting.
B5.1110

Data management, search request, donor matching tocandidate recipients and selection of CB units.

B5.111122

Procedures for collection and analysis of transplant
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outcome data.
B5.1112

Personal

training

anddocumentationofcontinued

competency for the procedures performed.
B5.1113

Laboratory management including supplies, maintenanceand monitoring of equipment, cleaning and sanitation
procedures, disposal of medical and biohazardous waste,emergency and safety procedures, and a disaster plan.

B5.120

Policies and Procedures Management Requirements
B5.121

All policies and procedures shall comply with theseStandards.

B5.122The policies and procedures shall carry the signature of the
CBB Director and the data of initial implementation. They
shall be reviewed by the CBB Director or designee, signed
and dated at least annually, and after each revision.

B5.123

Copies of the policies and procedures of the CBB shall beavailable to the CBB personnel at all times.

B5.124The CBB shall record and maintain archived proceduresand protocols in their historical sequence indefinitely,
including inclusive dates of use.

B5.125The policies and procedures for collection and processingof CB units and the manufacturing of supplies and reagents,
shall define the objectives of the procedures, acceptableend-points, and the range of expected results.

B5.126The CBB Director or designee shall review all deviations
from the CBB policies and/or procedures or from theseStandards. This review and associated training shall be
documented.

B5.130All personnel shall follow the policies and procedures establishedby the CBB.

B5.140Operational Requirements
B5.141

There shall be a system to maintain the confidentiality of
the CB donor and recipient, according to applicable laws
governing confidentiality of health information.

B5.142

There shall be a system to confirm the correct
identification of the CB unit, reference samples and,
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maternal samples.
B5.143

There shall be a system capable of tracking and tracing all
CB units and samples between donor and recipient.

B5.144

There shall be a system to confirm that test results for the
CB units and maternal samples are within specifications
prior to acceptance for release.

B5.145

In

the

case

of

multiple collection

facilities, theresponsibilities of the collection facilities and theprocessing laboratory for all aspects of processing,collection, testing, banking, storage and release shall beclearly defined. The CBB Director shall be ultimately
responsible for the entire operation.
B5.146The CBB shall use methods, equipment and supplies tomaintain the viability of the CB units and to prevent the
introduction of adventitious agents.

B5.300Non-Conforming Units
B5.310

The CBB shall have a system for the identification of any units
that do not fully meet these standards and the facility
requirements.

B5.320

The CBB shall maintain a record of non-conforming units that arebanked and/or released. The nature of the nonconformity shall be
communicated to the Transplant Facility when one such unit is
proposed for clinical use.

B5.400Errors And Accident Reporting Requirements
The CBB shall have a system and procedure for monitoring,detecting, documenting and reporting deviations, errors andaccidents. These shall be evaluated by the appropriate Director
and/or Medical Director together with the Quality Management
and other appropriate staff.
B5.410

Corrective actions shall be implemented and documented by theappropriate Director of the involved facility.

B5.420

The CBB Director or Medical Director shall designate a time atwhich the outcome of the corrective actions shall be evaluated.

B5.500Adverse Reaction Files
B5.51024

Records shall be maintained of all severe or unexpected adverse
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reactions in the mother or infant arising as a result of collection of
the CB unit.
B5.520Records shall be maintained of all severe or unexpected adverse
reactions resulting from transplantation of the CB unit, including
acute toxicity associated with infusion of the CB unit and failed
engraftment Section E8.000 applies.

B5.530A thorough investigation of each reported adverse reaction shallbe made by the bank in collaboration with the collection facility
and/or transplant program. A written report of the investigation
including conclusions, follow-up, and corrective action, if
applicable, shall be prepared and maintained as part of the record
for that final CB unit.

B5.540

When it is determined that the CB unit was responsible for theadverse reaction, copies of the written reports shall be forwarded
to the Transplant Facility involved.

B5.600

Clinical Outcome Data Requirements
For unrelated allogeneic, related allogeneic and autologous CB units
released, the CBB shall maintain details of clinical outcome as necessary
to assure that the procedures in use in the CBB continuously provide asafe and effective component. Sections E5.000 and E8.000 apply.
B5.610For unrelated allogeneic, related allogeneic and autologous CB
units, data shall include records of neutrophil and platelet
engraftment.

B5.620For unrelated allogeneic, related allogeneic and autologous CB
units, data should include survival rates.

B5.630For unrelated and related allogeneic CB units only data should
include chimerism and GVHD results.

B5.700

Validation And Qualification Requirements
B5.710

Procedures shall be developed, implemented, and documented forthe validation of qualification of significant aspects or the CBB
functions. Determination of which elements are to be validated or
qualified shall be made by the CBB Director(s) in collaboration
with the Quality Management program. Section D9.000 applies.

B5.720Records shall be maintained to document that procedures havebeen validated to achieve the expected end points.
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B5.730

Successful validation shall be signed and dated and shall beaccompanied, when appropriate, by quality control procedures
developed specifically to monitor the continuing adequacy of theprocedures, reagents, equipment and supplies as used underroutine operating conditions by the CBB personnel. Validation
studies shall be reviewed and approved by the CBB Director, ordesignee from the quality assurance program.

B6.000

INSTITUTIONAL REVIEW BOARD REQUIREMENTS

B6.100In compliance with governmental regulations, the CBB shall have formal
review of investigational protocols for CB collection or consent by amechanism that is approved by the Office of Human Research Protections
under the Department of Health and Human Services (HHS), the Foodand Drug Administration (FDA), or by equivalent health agencies outside
the United States.

B6.200

The CBB shall maintain documentation of all research protocols,
Institutional Review Board approvals, investigational new drug or device
exemptions, annual reports, and any adverse outcome reports.

B7.000

INDENTIFICATION AND LABELING REQUIREMENTS

B7.100Labeling Operations
B7.110Labeling operations shall be conducted in a manner adequate toprevent mislabeling of CB units and reference samples.

B7.120

There

shall

be

a

bar-codingorequivalent

human-andmachine-readable system of identification for the maternal
specimen, the CB unit, reference samples and their associateddocuments. The identification system shall be validated.
B7.130The labeling operation shall include at least the following
controls:
B7.131

Labels

shall

be

held

upon

receiptfromthemanufacturer pending review and proofing against an
approved copy to ensure accuracy regarding identity,content, and conformity.
B7.13226

StocksofunusedAsiaCORD

labelsrepresenting

different

components shall be stored and maintained in a manner
to prevent errors. Stocks of obsolete labels shall be
destroyed.
B7.133

A system of checks in labeling procedures shall be
used to prevent errors in transferring information tolabels.

B7.134All labeling shall be clear and legible and printed using
indelible ink.

B7.135The labeling system shall be validated as reliable forstorage under the conditions in use.

B7.140The information provided on the label by the initial collection
facility shall be maintained indefinitely as part of the CB
processing record.
B7.141

CB units that are subsequently processed may be
packaged into new bags with new labels as appropriate.
The establishment of this linkage shall be validated.

B7.150

When the label has been affixed to the bag, a sufficient area of the
bag shall remain uncovered to permit inspection of the contents.

B7.200Identification
B7.210Each CB unit shall be assigned a unique numeric or alphanumeric
identifier by which it will be possible to relate any CB unit to its
maternal and infant data, delivery information, family history, test
results, and to all records describing the handling and final
disposition of that CB unit.

B7.220

Facilities may designate an additional or supplementary uniquenumeric or alphanumeric identifier to the CB unit or to atestaliquot. Supplementary identifiers shall not obscure theoriginal identifier. No more than one supplementary identifier
shall be visible on a CB unit bag.

B7.300Partial Label
B7.310If the collection or freezing bag is capable of bearing only a partial
label, the container shall show at a minimum the proper name
“Cord Blood” and the unique numeric or alphanumeric identifierof the CB unit.
B7.311

For related allogeneic or autologous donations, theAsiaCORD

27

name and/or identifier of the intended recipient, if
known, shall be included.
B7.320At time of issue for infusion or transfer to another facility,
collection bags bearing a partial label shall be accompanied by thefull information in Section C4.600, and freezing bags bearing apartial label shall be accompanied by the full information in
Section D5.000. Such information shall be attached securely to the
CB unit on a tie tag or enclosed in a sealed package.

B7.330For labeling at the completion of collection, Section C4.600
applies.

B7.340For labeling at the completion of processing. Section D5.000
applies.

B7.350For labeling at time of issue for transplantation, Sections E5.500
and E5.600 apply.

B8.000SUPPLIES, REAGENTS AND EQUIPMENT REQUIREMENTS

B8.100

There shall be a program of quality assurance that is sufficiently
comprehensive to ensure that reagents, equipment and procedures
function as expected.

B8.200All supplies and reagents used in the collection, processing, freezing, andinfusion of the CB unit that come into contact with the CB shall be sterile,including those reagents manufactured by the processing facility.

B8.300

Supplies and reagents should be used in a manner consistent with
instructions provided by the manufacturer.

B8.400

Whenever possible, supplies and reagents used for CB collection,
processing and cryopreservation shall be approved for human use.

B8.500

Supplies and reagents not approved for human use may be used if.
B8.510The supplies or reagents are specified in a procedure that hasreceived Institutional Review Board approval at the each bank,and/or Investigational New Drug or Device Exemption (orequivalent outside the United States), or

B8.520The procedure that includes the specified supplies or reagents has
been used in Institutional Review Board-approved trials and has
been established in the medical literature to be acceptable for the
purpose(s) specified.

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B8.600

Equipment used in the collection, processing, testing, freezing, storage,transportation, and infusion of CB shall be maintained in a clean andorderly manner and located so as to facilitate cleaning and maintenance.
B8.610Equipment shall be observed, tested and calibrated on a regularlyscheduled basis as described in standard operating procedures.

B9.000RECORDS REQUIREMENTS

B9.100General Records Requirements
B9.110Records shall be made concurrently with each stage of the CB
collection, processing, testing, banking, selection, release,transplantation and/or disposal of each CB unit in such a way thatall steps may be accurately traced.

B9.120Records shall be legible and indelible, shall identify the person
immediately responsible for each step, and shall include dates (andtimes where appropriate).

B9.130Records of each step shall be as detailed as necessary for a clear
understanding by a person experienced in CBB procedures andshall be available for inspection by authorized individuals.

B9.140Records shall be available from which to determine the lot number,
expiration date and manufacturer of supplies and reagents used forthe collection and processing of each CB unit.

B9.150Records shall be maintained in such a way as to assure theirprotection and preservation.

B9.160Records related directly to the collection, processing, testing,banking, selection and/or release of CB units shall be maintained
indefinitely.

B9.170Records related to quality control, personnel training orcompetency, equipment maintenance, sterilization of supplies andreagents, disposition of rejected supplies and reagents, or otherlaboratory management issues shall be retained for 10 years by the
CB collection or processing facilities, although not all need be
immediately available. Section B9.300 applies.

B9.200Confidentiality Of Donor And Family In The Records
B9.210

All records and communications among the collection, processing
and transplant facilities and their patients shall be regarded as
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privileged and confidential.
B9.220Informed consent shall include knowledge that linkage of donor
and mother with the CB unit is maintained. Section C2.000
applies.

B9.230

The CBB shall have written policies and procedures forcircumstances where donor, mother or donor's legal guardian andappropriate medical personnel could be contacted.

B9.240

There shall be a system to maintain the confidentiality of thedonor, family, and recipient that shall be secure within the CBBsuch that demographic data are available only when needed andonly to authorized personnel.

B9.300Records To Be Maintained
Records that shall be maintained include the following. Sections B9.160,
B9.170 and B9.200 apply.
B9.310

Donor and parental records− indefinite retention
B9.311

Medical history of the biological mother; the birthmother if applicable; and the biological father, if his
history is available; copies of consent forms; andresults of laboratory tests.

B9.312

Mother's full name, address; neonatal delivery date;and if available, infant's full name and address andfather's full name and address.

B9.313

Maternal or infant adverse reactions, complaints andreports, including results of all investigations andfollowup.

B9.320CB Unit Records− indefinite retention
B9.321

Identity of all facilities involved in the collection,
processing, testing, banking, selection and release of
the CB unit.

B9.322CB unit processing worksheets including lot numbers
and expiration dates of reagents and supplies used.

B9.323Documentation and interpretation of all test results.

B9.324

Records of cryopreservation procedure and storage,
identified by device, date and CB unit identifier.

B9.32530

Results of confirmatory testing performed prior to CB
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unit release.
B9.326

Distribution and disposition of CB units.

B9.327

Reasons for exclusion of CB units collected but notbanked.

B9.330Quality assurance records− minimum 10-year retention
B9.331

Periodic performance checks of equipment andreagents.

B9.332

Tests of capacity of shipping containers to maintainproper temperature in transit.

B9.340B9.333

Proficiency test results.

B9.334

Validation studies.

B9.335Results of inspection and accreditation visits.

General records− minimum 10-year retention
B9.341

Sterilization of supplies and reagents prepared within
the facility, including date, time interval, temperatureand method used.

B9.342

Personnel employed by the CBB responsible for CB
unit collection and processing, their signature, initials
and inclusive dates of employment.

B9.343

Technical personnel training, continuing education, andperiodic competency testing.

B9.344

Errors and accidents and corrective action taken.

B9.345Maintenance records for equipment and facilities

B9.346

Supplies and reagents, including name of manufacturerof supplier, lot numbers, date or receipt and expiration.

B9.347B9.400

Disposition of rejected supplies and reagents.

Electronic Records
B9.410If an electronic record-keeping system is used, there shall be asystem to ensure the authenticity, integrity and confidentiality of
all records.

B9.420

There shall be protection of the records to enable their accurate
and ready retrieval throughout the period of record retention.

B9.430The facility shall have an alternative system that ensurescontinuous operation in the event that primary electronic data are
not available. The alternative system shall be tested periodically.
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B9.440

There shall be established written procedures for record entry,
verification and revision. A system shall be established for displayof data before final acceptance.
B9.441

The quality assurance system shall include anassessment of electronic functions to ensure that errors
and problems are reported and resolved.

B9.450

There shall be a system whereby access is limited to authorizedindividuals.

B9.460

There shall be the ability to generate true copies of the records inboth paper and electronic forms suitable for inspection and review.

B9.470

When a computer system is used, there shall be validated
procedures for and documentation of:
B9.471

Systems development.

B9.472

Numerical designation of system versions if applicable.

B9.473

Prospective validation of system, including hardware,
software, database and peripheral devices.

B9.474

Installation of the system.

B9.475Training and continuing competency of personnel insystems use.

B9.480B9.476

Monitoring of data integrity.

B9.477

System maintenance and operations.

All system modifications shall be authorized, documented, andvalidated prior to implementation. Documentation shall becomplete, in a language understandable by users.

B9.490The computer system shall ensure that all donor, unit, and patient
identifiers are unique.

B9.500Records In Case Of Divided Responsibility
B9.510If two or more facilities participate in the collection, processing oftransplantation or the CB unit, the records of each facility shallshow plainly the extent of its responsibility

B9.520Each participating facility shall furnish to the facility of final
disposition a copy of records relating to the collection andprocessing procedures performed in so far as they concern thesafety of the CB unit.

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PART C: CORD BLOOD DONOR AND COLLECTION STANDARDS

C1.000DONOR EVALUATION
C1.100

There shall be donor evaluation procedures in place that protect therecipient against transmitted disease and also protect the safety andconfidentiality of the CB donor and mother. Both the potential for diseasetransmission from the donor to the recipient and the risks to the donor andmother from the collection procedure shall be assessed. Donor andmaternal evaluation test results shall be documented.
C1.110Any abnormal findings that suggest infection in mother or infant
shall be reported to the mother and/or her physician in writing. If
the abnormality is potentially urgent, the mother's or infant's
physician should be notified immediately.

C1.120

When a mother does not meet the criteria below, the CB
Collection Center Director or Medical Director shall document
and maintain in the permanent record the nature of the variances
and the rationale for inclusion of that CB unit.

C1.200Maternal and CB Donor Screening and TestingC1.210

There shall be written criteria for CB donor selection.

C1.220A genetic history shall be obtained and documented from thebiologic mother, and if available, from the father. The history
should include the infant's ethnicity (mother's and father's family
including parents and grandparents) and the potential presence ofinherited disorders of the hematopoietic or immunologic systems.

C1.230A medical history for mother's infectious risk behavior shall beobtained and documented.
C1.231This history shall include mother's prenatal infectious
disease testing, if known, and results of other general
medical testing that could influence infectious disease
and/or genetic disease transmission.

C1.232In the case of a surrogate mother who carries todelivery a fertilized egg, an infectious disease risk
history of the surrogate shall also be obtained anddocumented.

C1.233

History of the current pregnancy and delivery, andAsiaCORD

33

infant's birth data shall be obtained and documented,
including gender, gestational age, and if available,
other results of clinical examination and any diseasediagnosed prior to discharge.
C1.234At the time of delivery, previously obtained history for
infectious disease transmission risk shall be updated.

C1.235

A blood sample from the birth mother shall be tested
for blood borne pathogens at the time of or up to 7 days
after collection of the CB unit.

C1.2351

Blood borne pathogen testing shall includeanti-HIV-1, anti-HIV-2, HIV-1-Ag, anti-HTLV I/II,
HBsAg, anti-HBc, anti-HCV, a serological test forsyphilis and any additional testing required bygovernmental regulation at the time of collection.
Testing should include anti-CMV.

C1.2352

Positive or indeterminate test results, excluding CMV,
shall be communicated to the mother and/or her
physician, and according to governmental reportinglaws.

C1.236The CBB shall have a written policy directing response
to indeterminate or positive results found during thescreening process and laboratory testing of maternal or
CB samples.

C1.237CB shall not be accepted for unrelated donortransplantation if there is a family history (biologic
mother, father, or sibling) of a genetic disorder that
may affect the recipient for which there is no test
available or inadequate follow-up to ensure the safetyof the CB unit.

C2.000

INFORMED CONSENT
C2.100Informed consent shall be obtained from the biologic mother prior to orwithin 7 days after delivery of the infant. Consent for CB collection shallbe obtained prior to the collection procedure when CB is collected withthe placenta in utero.

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C2.110

In cases of a surrogate mother, informed consent shall be obtained
from both the surrogate and the biologic mother.

C2.120Informed consent should not be obtained while the mother is in
active labor.

C2.200The formal aspects of participation in the CBB shall be discussed with themother in language with which she feels comfortable. The explanations
shall include at least the overall purpose; the possible risks, benefits, andalternatives of CB donation to the mother or infant including medical andethical concerns; and the right of the mother to refuse without prejudice.

C2.300

There shall be an informed consent process that includes the elements inC2.200 and at least the following.

C2.310Donation of the CB for use in transplantation specifying the intent
of the donation.
C2.311If

thecollection

is

for

unrelatedallogeneictransplantation, the CB unit is a donation that will bemade available to other individuals and will notnecessarily be available to the donor or the donor'sfamily at a later date.
C2.312

If the collection is intended for related allogeneic or
autologous transplantation, the release of the CB unit
will be limited respectively to the specified family
recipients or the donor.

C2.320Interview for personal and family medical history.

C2.330

Review of the medical record of the mother and infant.

C2.340

The CB collection procedure.

C2.350

Collection of blood from the mother and infectious and genetic
disease testing on the CB unit and maternal blood as applicable.

C2.360Storage of reference samples for future testing.

C2.370

Maintenance of linkage, whenever possible, for the purpose of
notifying donor/family of infectious or genetic diseases. Section
B9.200 applies.

C3.000C2.380Use of CB unit for research, quality control or validation studies.

C2.390

Disposal or release of CB units not meeting criteria for banking.

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C3.100

The Collection Facility refers to the site where the infant is delivered andthe CB unit is collected.

C3.200

There shall be a CB Collection Facility Medical Director who is alicensed physician. The CB Collection Facility Medical Director shall be
responsible for the medical aspects of CB collection procedures andcompliance of the CB Collection Facility with these Standards.
C3.210

Where there are remote collection facilities shipping CB to acentral laboratory, the CBB Medical Director may serve as theCollection Facility Medical Director, and need not be licensed in
the jurisdiction of the collection or be on the staff of the facility
where the collection takes place.

C3.220

In utero collections shall be performed by a physician, midwife or
nurse trained in the collection procedure and licensed to practicein the jurisdiction where the collection takes place.

C3.300

There shall be adequate numbers of trained collection personnel available
at the facility where the collection is performed. Training shall be specificfor the function to be performed, and shall be documented.

C3.400

There shall be a designated area for appropriate preparation and storage ofthe reagents, supplies and equipment needed for the collection
procedures.

C3.500

There shall be adequate space for the performance of the collection
procedure.

C3.600

There shall be adequate space for storing the CB unit temporarily until it
is transported to the laboratory.

C3.700

There shall be emergency medical care available for the mother andinfant.

C4.000

CORD BLOOD COLLECTION PROCEDURES
C4.100CB collection procedures and practices shall protect mother and infant.
C4.110

Delivery practices shall not be modified in attempt to increase CB
volume.

C4.200

When in utero CB collection is performed there shall be additionalsafeguards in place to ensure safety of mother and infant.
C4.210CB collections should only be performed in utero fromdocumented singleton deliveries.

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C4.211

If CB collection is performed in utero in a multiple
gestation pregnancy, all infants shall be delivered
before any CB collection begins.

C4.220

In utero CB collections shall only occur in uncomplicated deliveries.

C4.230CB units shall be obtained in utero from infants after at least 34 weeks
gestation.

C4.300

Collection of CB shall be performed according to written policies andproceduresC4.310

Methods for collection shall employ aseptic technique and shalluse procedures validated to result in acceptable progenitor cell
viability and recovery. Section B5.700 applies.

C4.320The primary CB collection bag shall be approved for use incollecting human blood and shall be used and sealed in a mannerthat minimizes the risk of cell loss and of microbial
contamination.

C4.330

All reagents and supplies for collection that come into contact
with the CB shall be sterile. Section B8.200 applies.

C4.340

Lot numbers and expiration dates of reagents and disposables usedin the collection procedures shall be recorded and sent to the CBB.
Sections B9.140 and B9.346 apply.

C4.400

There shall be a unique identifier for the CB unit, samples, and data forms.
Section B7.200 applies.

C4.500

There shall be a written policy at the collection site for labeling of CB
unit. Section B7.000 applies.

C4.600On completion of collection, the primary collection bag shall bear thefollowing information.
C4.610

The CB unit's unique numeric or alphanumeric identifier.

C4.620The proper name of the CB unit

Cord Bloodin a prominent

position.
C4.630The collection center identifier, and the donor identifier.

C4.640Name of physician, date and time of collection (and time zone if
applicable).

C4.650Name and volume of anticoagulant and any other additives.

C4.660

The approximate volume of the collection.

C4.670

For related allogeneic and autologous directed donations: the
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37

donor's name and, if applicable, the recipient's name and a uniquepatient identifier or other identifier of intended recipient or family.
C4.700

There shall be a written policy for storage of CB units and samples at thecollection site prior to transport to the processing facility.

C4.800Records shall be maintained of all reports of adverse reactions that occur
during or immediately after collection. Section B9.000 applies.

C5.000TRANSPORTATION OF NON-CRYOPRESERVED CORD BLOOD UNITSBETWEEN CORD BLOOD COLLECTION SITE/FACILITY AND THE CORD
BLOOD PROCESSING LABORATORY
C5.100The methods of transportation of the CB unit between the collection site
and the processing laboratory shall be designed to protect the integrity of
the unit being transported and the health and safety of facility personnel.

C5.200The primary CB collection bag shall be placed in a sealed secondary
plastic bag to contain any leakage from the primary bag.

C5.300

Shipping Container (Box)C5.310The shipping container shall be of a design to minimize
temperature changes during transportation.

C5.320Transportation of CB units shall be in compliance with applicablegovernmental laws. The outer shipping container shall be made ofmaterial adequate to withstand leakage of contents, shocks,
pressure changes, and other conditions incident to ordinary
handling in transportation.

C5.330The shipping container shall carry the following labels.
C5.331“Cord Blood for Transplantation”, a label indicatingthat the shipment should not be exposed to radiation,
and an appropriate biohazard label in compliance withregulations for the transport of human blood.

C5.332The shipping container shall also include the name,address and phone number of the shipping facility; thename, address, and phone number of the receiving
facility; and the name of the person responsible forreceipt of the shipment.

C5.40038

Transport Records
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C5.410

Transport records shall permit the tracing of the CB unit from thecollection facility to its final destination.

C5.420Transport records shall identify the source facility responsible forshipping the CB unit, and the date and time of shipping andreceipt of the unit.

C5.430Transport records shall document the identity of the courier, if
pertinent and the date and time of receipt of the package.

C5.440A shipping list identifying each unit enclosed in a package shall be
included.

C5.450Transport records shall be maintained indefinitely.

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PART D: CORD BLOOD PROCESSING STANDARDS

D1.000

GENERAL REQUIREMENTS
D1.100Laboratory Facilities
Section B2.000 applies.

D1.200

SafetySection B3.000 applies.

D1.300

Personnel
Section B4.000 applies.

D1.400

Supplies And Reagents
Sections B8.100 through B8.500 apply.

D1.500Equipment
Sections B8.100 and B8.600 apply.

D2.000

CORD BLOOD PROCESSING
D2.100General Principles
D2.110A CBB shall use collection facilities that meet AsiaCORD
Standards with respect to its interaction with that CB Processing
Facility.

D2.120Prior to processing any CB unit, there shall be a written agreement
between the CBB and the facility where the unit was collected of
the collection team.

D2.130In the case of related allogeneic or autologous directed donors, awritten physician's order for processing and storage shall beobtained including the name of the intended recipient, if known.

D2.140

Processing of CB units shall be performed according to a validated
Standard Operating Procedure.

D2.150CB units shall be processed and frozen within 48 hours ofcollection using a controlled rate freezing method.

D2.160Unless included in an IRB-approved protocol or equivalent
governmental regulatory oversight, CB unit processing shall be
restricted to volume reduction by depletion of erythrocytes and/or
plasma.

D2.17040

Any other manipulation as defined in D5.160 shall only be
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performed:
D2.171

with Institutional Review Board approval or its
equivalent the appropriate governmental agency, orD2.172using reagents and/or devices approved for thatmanipulation by the appropriate governmental agency.

D3.000

REVIEW OF PROCESSING RECORDS
Records pertinent to the CB unit shall be regularly reviewed by the Laboratory
Director or designee. Failure of the processing procedure to achieve acceptableendpoints shall be evaluated and documented.

D4.000REFERENCE SAMPLES
D4.100The following samples shall be collected from the unrelated allogeneic,
related allogeneic, or autologous CB units prior to cryopreservation.
D4.110

A reference aliquot of each CB unit that is stored for clinical use
shall be sealed in the tubing tha is integrally attached to thefreezing bag.

D4.120

At a minimum, the following samples from each CB unit shall be
stored and available for testing.
D4.121

Serum or plasma from non-heparinized samples (atleast 2 vials, 2 ml each; should be stored at below-18℃).

D4.122Cells cryopreserved in a manner to maintain viability(at least 2 vials with 1-2×106 mononuclear cells pervial) stored under conditions to maintain long-term
viability.

D4.123

Suitable material for preparation of at least 50 μg
genomic DNA. This may be purified DNA, frozen
cellular material or blots.

D4.200The following samples for unrelated allogeneic CB units shall becollected from the CB donor's mother at, or after the time of CB unit
collection, but prior to release of that unit.
D4.210From the birth mother: Serum or plasma from non-heparinizedsamples (at least 2 vials, 2 ml each, should be stored at below
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41

-18℃).
D4.220From the biologic mother: Suitable material for preparation of atleast 50 μg genomic DAN. This may be purified DAN, frozen
cellular material or blots.

D5.000LABEL AT COMPLETION OF PROCESSING
D5.100Upon completion of processing, and before release to a transplant facility,
the label on the CB unit shall bear the following information.
D5.110

The CB unit's unique numeric of alphanumeric identifier.

D5.120The proper name, “Cord Blood”, any appropriate modifier(s), anda statement to indicate intended recipient and unit identificationmust occur before infusion and a warning that this CB unit may
transmit infectious agents.
D5.121Each CB unit intended for autologous use shall beprominently labeled “For Autologous Use Only” andthe donor/recipient's name and unique patient
identifier.

D5.122Each CB unit intended for directed allogeneic use
shall be prominently labeled: “For Use By Intended
Recipient Only” and the recipient's name and uniquepatient identifier, if known.

D5.130The ABO group and Rh type of the donor conspicuously
designated.

D5.140Name and volume of any additive including, but not limited to,
anticoagulant, electrolyte solutions, and/or cryoprotectant.

D5.150

The approximate volume of the CB unit.

D5.160

Method(s) used for CB unit manipulation, if applicable, including
but not limited to: depletion, positive-selection, ex vivo expansion
and gene-manipulation.

D5.170

The recommended storage temperature range of the CB unit indegrees Celsius.

D5.200D5.180The name and address of the processing facility.

D5.190A BIOHAZARD label if indicated.

If the space on the CB unit does not allow for a complete label, a partial
label as defined in B7.300 shall be used.

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D6.000

CRYOPRESERVATION
D6.100CB units shall be cryopreserved using a controlled rate freezing procedurevalidated to maintain viability. Any other cryopreservation technique shallbe validated to maintain viability. Section B5.700 applies.

D6.200Frozen CB units shall be stored in approved freezing bags designed forthe cryopreservation of human cells and placed into metal canisters toprovide protection during freezing, storage and transportation. Any othercryopreservation system shall be validated.
D6.210Each CB unit freezing bag and its satellite container(s), if any,
shall be examined visually for damage or possible contamination
prior to its use and immediately after filling. Such examination
shall include inspection for breakage of seals. The results of thisinspection shall be documented.

D6.300Cryopreservation protocols shall specify the following:D6.310The cryoprotectant and its final concentration.

D6.320Total nucleated cell concentration.

D6.330

Method of freezing and endpoint temperature of cooling.

D6.340

Cooling rate.
D6.341

A record of the cooling rate shall be archived for each
CB unit that is frozen.

D6.350Storage temperature.

D6.360The procedure shall minimize transit time of frozen units between
freezing and storage devices.

D7.000CONDITIONS FOR STORAGE
D7.100CB units shall be maintained in quarantine storage until all infectious
disease test results have been obtained, and the CBB Director or designee
has reviewed the record and approved the CB unit for permanent storage.
D7.110Records shall indicate when CB unit was released from quarantine
and placed in permanent storage.

D7.120CB units with positive or indeterminate test results for HIV, HTLV,HCV or HBsAg shall be maintained in permanent quarantine
storage.
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43

D7.130

CB units intended for unrelated or related allogeneic use that are
positive for HIV shall not be used for human transplantation.

D7.200

Facilities storing CB units shall establish policies for the duration andconditions of storage and indications for discard.
D7.210Refrigerators and freezers used for the storage of specimens, CB
units, blood components, human tissues, or reagents shall not be
used for any other purpose.

D7.220

There shall be a written procedure for the transport and alternate
place of storage of CB units in the event of a disaster.

D7.300

Security
D7.310The storage device shall be located in a secure area and shall havelocking capability that is used at least when the area is not
occupied.

D7.400An inventory control system shall be operational. Such a system shall beable to locate any CB unit and its available associated reference samples.

D7.500Temoerature
D7.510Frozen storage shall be at a temperature no higher than -135℃
and within a temperature range determined to be appropriate forthe cryoprotectant and defined in the standard operatingprocedures.

D7.520For CB units stored in liquid nitrogen, procedures to minimize therisk of microbial cross-contamination of units shall be defined andmaintained.

D7.530

Exposure of frozen units to temperature fluctuations shall beminimized.

D7.600

Monitoring And Alarm Systems
D7.610Freezers for CB unit storage shall have a system to monitor thetemperature continuously and to record the temperature at least
every 4 hours.
D7.611For CB units fully immersed in liquid nitrogen,continuous temperature monitoring is not required.

D7.620Liquid nitrogen freezers shall have a mechanism to ensure that
adequate levels of nitrogen are maintained.

D7.630Alarm Systems
D7.63144

Storage devices shall have alarm systems that are
AsiaCORD

continuously active.
D7.632

Alarm systems shall have audible and visible signals.

D7.633

The alarm system shall be capable of notifying
designated personnel 24 hours a day.

D7.6331

A standard operating procedure for notifying
designated staff shall be placed at each remotealarm location and in the immediate area of thestorage device.

D7.634

Alarm parameters shall be set to allow staff sufficient
time to salvage CB units.

D7.635

Alarm systems shall be checked periodically for
function. The records of such checks shall bemaintained and be available for inspection.

D8.000DISPOSAL
D8.100

There shall be a written policy for disposal of discarded CB units.

D8.200

The records for discarded CB units shall indicate the unique identifier ofthe unit, and the reason, date and method of disposal.

D8.300

For related allogeneic and autologous directed CB units, there shall be
written documentation of patient death or no further need for the unit
before any unit is discarded. It the donor is alive, informed consent for
disposal shall be obtained.
D8.310

The CBB Director or designee in consultation with the patient’s
transplant physician shall approve of the unit disposition.

D8.320If the patient is still alive his/her consent for disposition of theunits shall be obtained. If consent is denied, the patient shall beoffered the opportunity to transfer the CB unit to another facility.

D8.400In case of a minor donor, informed consent shall be obtained from thedonor’s biologic mother or legal guardian in accordance with applicablelaw.

D8.500In the event the CBB is no longer able to maintain a related allogeneic or
autologous directed unit in inventory, it is the responsibility of the CBB toprovide for appropriate storage of the unit in another accredited CBB
facility and to inform the patient of this.

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D9.000QUALITY MANAGEMENT
Section B5.000 applies.
D9.100Laboratory Controls
D9.110Laboratory control procedures shall include.
D9.111The establishment of scientifically sound appropriate
assays, standards and test procedures for theevaluation of the CB unit.

D9.112Adequate provisions for monitoring the reliability,
accuracy, precision and performance of laboratory test
procedures and instruments.

D9.113Adequate identification and handling of all test
samples so that they are accurately related to thespecific CB unit being tested, to its donor, or to thespecific recipient, as applicable.

D9.200

Testing Of Cord Blood Units
D9.210The following tests shall be performed on a pre-cryopreservation
sample from each CB unit. If thawed samples are used, thelaboratory shall demonstrate correlation with precryopreservation
values.
D9.211

Total nucleated cell count from the final CB productat end of processing. Nucleated red blood cell countshould be included.

D9.212

Total number of CD34-positive cells and/or total
number of hematopoietic colony-forming cells fromthe final CB product at end of processing.

D9.213

Microbial cultures of CB units on a sample of CB
obtained after processing using a system permissive
for the growth of aerobic and anaerobic bacteria as
well as fungi.

D9.2131

The results of positive microbial tests shall
include identity of the organism(s). Antibiotic
sensitivities for aerobic bacteria shall be
performed prior to release of the CB unit fortransplantation. These results shall be reported to46

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the prospective Transplant Facility.
D9.214

ABO group and Rh type.

D9.215

Human leukocyte antigen (HLA) type for unrelated
allogeneic and related allogeneic use.

D9.2151

HLA-A, B and DRB1 loci shall be determined.

D9.2152

HLA-C, DQA and DQB should be determined.

D9.2153

HLA Class 1 typing may be performed byserological methods. Ambiguous results shall be
confirmed by DNA techniques. All Class if
typing shall be performed by DNA techniques.

D9.216

For unrelated allogeneic and related allogeneic CB
units, hemoglobin electropheresis shall be performedin ethnic groups at high risk for hemoglobinopathies
or where indicated by family history.

D9.220Prior to release for transplantation, each CB unit shall be tested forHIV-1, HIV-2, HTLV-1, HTLV-11, HCV and HBsAg.

D9.230If the CB unit is collected for related allogeneic or autologous use
but then released for unrelated allogeneic use, samples shall meetfull unrelated allogeneic banking criteria as described above.
Sections B, C, and D apply.

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PART E SELECTION, RELEASE AND SHIPPING OF CORD BLOOD UNITS
E1.000

GENERAL REQUIREMENTS FOR UNRELATED ALLOGENEIC CORD
BLOOD UNITS
E1.100

The CBB shall have policies and procedures for the selection, release andtransport of CB units to Transplant Facilities.

E1.200

The CBB shall maintain records on each search request.

E1.300

The CBB shall have an electronic record system that enables search andmatch operations.

E1.310If an outside agency is used for search and match functions, theirelectronic record system shall meet AsiaCORD Standards (for the
future).

E1.400

The CBB shall utilize validated procedures for the performance ofdonor-recipient matching and for reporting results within a defined time
limit.

E1.500

There shall be a system to document requests for CB units, reference
samples from units, requests for and results of testing, and transportationof units and samples between facilities.

E1.600

The CBB should have links or exchange agreements with other CBBs tofacilitate the identification of optimal CB units for recipients.

E1.700

The CB unit should be received by the Transplant Facility prior toinitiation of the recipient’s preparative regimen.

E2.000

GENERALREQUIREMENTSFOR

RELATEDALLOGENEICAND

AUTOLOGOUS CORD BLOOD UNITS
E2.100

The CBB shall have policies and procedures for the selection, release andtransport of CB units to Transplant Facilities.

E2.200

There shall be a system to document requests for CB units, reference
samples from units, requests and results of testing, and transportation ofunits and samples between facilities.

E3.000

CORD BLOOD SELECTION FOR UNRELATED OR RELATED ALLOGENEIC
CORD BLOOD TRANSPLANTATION

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E3.100

Once a CB unit is identified for potential use, a sample of that unit shallbe tested to verify HLA type and cell viability. Where possible, thissample shall be obtained from a contiguous segment. Section D4.100
applies.

E3.200Samples of DNA (or material to isolate DNA) from the requested CB unit
shall be provided to the Transplant Facility’s designated HLA testinglaboratory for confirmation of HLA type unless independently verified
results have been previously obtained and documented.
E3.210A copy of the results of such confirmatory testing shall beobtained, recorded, and provided to the CBB. This copy shall bearchived and used in the future to support the identity of thesample when offering the CB unit to another Transplant Facility.

E3.300Prior to release of a CB unit, the CBB shall provide to the Transplant
Facility the following processing data, testing results and donor/maternal
medical history.
E3.310Total nucleated cell count of the CB unit at the end of processing,prior to cryopreservation. Nucleated red blood cell count should
be included. Section D9.211 applies.

E3.320Total number of CD34-positive cells or hernatopoietic colony
forming cells. Section D9.212 applies.

E3.330

HLA Class I and II typing. Sections D9.215, E3.100 and E3.200
apply.

E3.340Microbial testing results of the CB unit. If aerobic bacteria are
documented in the CB unit, antibiotic sensitivities shall be
provided. Section D9.213 applies.

E3.350

Infectious disease testing results performed on the maternal blood
sample and on the CB unit. Sections C1.2351 and D9.220,
respectively, apply.

E3.360Risks of infectious and/or genetic diseases disclosed by thematernal medical and genetic screening or clinical chart review,and the results of any investigation or further testing performed.

E3.400Confirmation of maternal haplotype should be provided.

E3.500Prior to release for allogeneic transplantation, the CBB shall obtain or
perform confirmatory HLA typing of the potential recipient
AsiaCORDs blood49unless this typing has been confirmed and updated on an independent
sample by the original laboratory or by an independent HLA laboratory.
E3.600Any variances in collection, processing, and/or storage procedures that
may influence the integrity and/or quality of the CB unit shall be reported
to the Transplant Facility. Section D9.200 applies.

E4.000

CORD

BLOOD

SELECTIONFORAUTOLOGOUS

CORD

BLOOD

TRANSPLANTATION
E4.100Once a CB unit is identified for potential use, a sample of that unit shallbe tested to verify cell viability. Where possible, this sample should beobtained from a contiguous segment.

E4.200Prior to release of a CB unit, the CBB shall provide to the Transplant
Facility the following processing data, testing results and donor/maternal
medical history.
E4.210Total nucleated cell count of the CB unit at the end of processing,prior to cryopreservation. Nucleated red blood cell count should
be included. Section D9.211 applies.

E4.220Total number of CD34-positive cells or hematopoietic colony
forming cells. Section D9.212 applies.

E4.230Microbial testing results of the CB unit. If aerobic bacteria are
documented in the CB unit, antibiotic sensitivities shall be
provided. Section D9.213 applies.

E4.240

Infectious disease testing results performed on the maternal blood
sample and on the CB unit. Sections C1.2351 and D9.220 apply.

E4.250Results of infectious disease screening disclosed by the maternal
medical history or clinical chart review, and the results of any
investigation or further testing performed.

E4.300Any variances in collection, processing, and/or storage procedures that
may influence the integrity and/or quality of the CB unit shall be reported
to the Transplant facility. Section D9.200 applies.

E5.000

CORD BLOOD UNIT RELEASE
E5.100

The CBB shall obtain a written request from the transplant physician forshipment of the CB unit.

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E5.200

The CBB Director or designee shall review the record including
processing, test results and medical history of each CB unit before its
release.

E5.300

When the maternal medical and/or genetic screening history indicatespotentially transmissible disease or when there is a positive orindeterminate infectious disease test result, the CBB Director or Medical
Director shall authorize release of the non-conforming CB unit anddocument the rationale for such authorization.
E5.310

Units deemed non-conforming as a result of the risk fortransmission of infectious disease by donor screening or testing
shall bear a BIOHAZARD label.

E5.400Documentation to accompany the CB unit shall include completedlabeling and should include instructions for the handling and use of theunit including thawing and washing.

E5.500At the time of issue for transplantation, a CB unit bearing a partial label
shall be accompanied by the full information in Sections C5.330 andD5.000, attached securely to the CB unit on a tie tag or enclosed in asealed package.

E5.600The completed label shall include the following; Sections B7.200 andB7.300 apply.

E6.000E5.610Name of the CBB.

E5.620Type of processing.

E5.630

HLA phenotype and the techniques used for typing.

E5.640

Number of nucleated cells.

E5.650Any deviations from compliance with these Standards.

TRANSPORT OF CRYOPRESERVED UNITS FROM THE CORD BLOODBANK TO THE TRANSPLANT FACILITY
E6.100TRANSPORT WITHIN A FACILITY
Procedures for transferring cryopreserved CB units that are to betransported or used within the CBB facility shall be designed to protect
the integrity of the CB unit and the health and safety of facility personnel.

E6.200TRANSPORT BETWEEN FACILITIES
E6.210

Procedures for transport of cryopreserved CB units shall be
designed to protect the integrity of the CB unit and the health andsafety of personnel.
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E6.220

The transit time between the CBB and remote facilities shall beminimized. There shall be plans for alternative transportation in an
emergency.

E6.230Cryopreserved units stored at a temperature below -135℃ shallbe transported in a liquid nitrogen-cooled “dry shipper” that
contains adequate absorbed liquid nitrogen and has been validated
to maintain temperature at least 48 hours beyond the expected
time of arrival at the receiving facility.
E6.231The shipping methods shall conform to existing
regulations regarding the mode of transport of suchdevices.

E6.232The dry shipper shall be labeled in accordance withapplicableregulations

regardingthecryogenic

material used and the transportation of biologic
materials.
E6.233The dry shipper shall contain a device that monitors
temperature throughout the shipment period.

E6.2331

The device that monitors temperature shall beeither an indicator showing that the temperature
limit has not been exceeded or a continuous
temperature recording device.

E6.240The shipping container shall carry the following labels:
E6.241“Cord Blood for Transplantation”, a label indicatingthat the shipment should not be exposed to radiation,
and an appropriate biohazard label in compliance withregulations for the transport of human blood.

E6.242The shipping container label shall also include thename, address and phone number of the shipping
facility, the name, address, and phone number of thereceiving facility; and the name of the person
responsible for receipt of the shipment.

E6.250Upon receipt, the receiving facility shall verify that thetemperature has remained within specified limits during theshipment, shall document and provide this documentation to the
CBB.

E6.300Once an unrelated CB unit has left the CBB premises it shall not be
returned to general CBB inventory.

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E7.000

TRANSPORT RECORDS
E7.100Transport records shall permit the tracing of the CB unit from theCollection Facility to its final destination.

E7.200Transport records shall identify the facility responsible for shipping the
CB unit, and the date and time of shipping and receipt of units.

E7.300Transport records shall document the identity of the courier, if pertinent,
the date and time of packaging; the date and time the package left thefacility, and the date and time of receipt of the package.

E7.400A shipping list identifying each unit enclosed in a package shall be
included.

E7.500E8.000Transport records shall be maintained indefinitely.

CLINICAL OUTCOME DATA
E8.100For every unrelated allogeneic, related allogeneic or autologous CB unit
released, the CBB shall maintain details of clinical outcome as necessary
to assure that the procedures in use in the CBB continuously provide asafe and effective component. Section B5.600 applies.
E8.110For unrelated allogeneic, related allogeneic and autologous CB
units, data shall include time to neutrophil and platelet
engraftment.

E8.120For unrelated allogeneic, related allogeneic and autologous CB
units, data should include survival rates.

E8.130For unrelated allogeneic and related allogeneic CB units only,
data should include chimerism and GVHD results.

E8.140For unrelated allogeneic, related allogeneic and autologous CB
units, data should include an infectious disease.

E8.200

The CBB shall collect viability and cell yield results on the thawed CB
unit.

E8.300

The CBB shall collect data on adverse events associated with infusion of
the CB unit.

E8.400

The CBB should report their clinical outcome data to cooperating cord
blood transplant registries such as AsiaCORD.

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