B6.4 ADDITIONAL REQUIREMENTS FOR ALLOGENEIC DONORS
B6.4.1 Allogeneic donors and allogeneic recipients shall be tested for ABO group and Rh type using two independently collected samples. Discrepancies shall be resolved and documented prior to issue of the cellular therapy product.
B6.4.2 A red cell antibody screen shall be performed on allogeneic recipients.
B6.4.3 Allogeneic donors shall be evaluated for risk factors that might result in disease transmission from the cellular therapy product by medical history, physical examination, examination of relevant medical records, and laboratory testing.
B6.4.4 The medical history for allogeneic donors shall include at least the following:
B6.4.4.1 Vaccination history.
B6.4.4.2 Travel history.
B6.4.4.3 Blood transfusion history.
B6.4.4.4 Questions to identify persons at high risk for transmission of communicable disease as defined by the applicable governmental authority.
B6.4.4.5 Questions to identify persons at risk of transmitting inherited conditions.
B6.4.4.6 Questions to identify persons at risk of transmitting a hematological or immunological disease.
B6.4.4.7 Questions to identify a past history of malignant disease.
B6.4.4.8 The allogeneic donor shall confirm that all the information provided is true to the best of his/her knowledge.
B6.4.5 Within thirty (30) days prior to collection, allogeneic HPC donors shall be tested for evidence of clinically relevant infection by the following communicable disease agents using tests as required by applicable laws and regulations:
B6.4.5.1 Human immunodeficiency virus, type 1.
B6.4.5.2 Human immunodeficiency virus, type 2.
B6.4.5.3 Hepatitis B virus.
B6.4.5.4 Hepatitis C virus.
B6.4.5.5 Treponema pallidum (syphilis).
B6.4.6 If required by applicable laws and regulations, allogeneic HPC donors shall also be tested within thirty (30) days prior to collection for evidence of clinically relevant infection by the following disease agents:
B6.4.6.1 Human T cell lymphotrophic virus I.
B6.4.6.2 Human T cell lymphotrophic virus II.
B6.4.6.3 West Nile Virus.
B6.4.6.4 Trypanosoma cruzi (Chagas’ Disease).
B6.4.7 Additional tests shall be performed as required to assess the possibility of transmission of other infectious or non-infectious diseases.
B6.4.8 For viable, lymphocyte rich cells, including therapeutic cells and other cellular therapy products, each allogeneic donor shall be tested for communicable disease agents listed in B6.4.5 and B6.4.6 within seven (7) days prior to or after collection in the U.S. or 30 days prior to collection in Europe, or in accordance with applicable laws and regulations.
B6.4.9 Allogeneic donors shall be tested for CMV (unless previously documented to be positive).
B6.4.10 Allogeneic donors and recipients shall be tested at a minimum for HLAA, B, DRB1 type by a laboratory accredited by ASHI, EFI, or equivalent. HLA-C testing shall be performed for unrelated allogeneic donors and related allogeneic donors other than siblings.
B6.4.10.1 DNA high resolution molecular typing shall be used for DRB1 typing.
B6.4.10.2 Verification typing shall be performed using an independently collected sample prior to allogeneic donor selection.
B6.4.11 Allogeneic donors shall be tested for red cell compatibility with the recipient where appropriate.
B6.4.12 Allogeneic donor eligibility, as defined by applicable laws and regulations, shall be determined by a physician after history, exam, medical record review, and testing, and shall be documented in the recipient’s medical record before the recipient’s preparative regimen is initiated and before the allogeneic donor begins mobilization regimen.
B6.4.13 The use of an ineligible allogeneic donor shall require documentation of the rationale for his/her selection and suitability by the transplant physician, urgent medical need documentation, and the documented informed consent of the donor and the recipient.
B6.4.14 Allogeneic donor eligibility and suitability shall be communicated in writing to the Collection and Processing Facilities.
B6.4.15 There shall be a policy covering the creation, regular review, and retention of allogeneic donor records.
B6.4.15.1 Allogeneic donor records shall include donor eligibility determination, including the name of the responsible person who made the determination and the date of the determination.
B7 THERAPY ADMINISTRATION
B7.1 The attending physician shall verify the availability and suitability of a donor or cellular therapy product prior to initiating the recipient’s preparative regimen.
B7.1.1 The clinical service shall notify the Processing Facility prior to requesting a cryopreserved cellular therapy product from a cord blood bank or registry.
B7.2 There shall be a policy addressing safe administration of the preparative regimen.
B7.2.1 There shall be a policy addressing safe administration of chemotherapy.
B7.2.1.1 The treatment orders shall include the patient height and weight, specific dates, daily doses (if appropriate), and route of administration of each agent.
B7.2.1.2 Preprinted orders or electronic equivalents shall be used for protocols and standardized regimens. These orders shall be verified and documented by an attending physician.
B7.2.1.3 The pharmacist preparing the chemotherapy shall verify and document the doses against the protocol or standardized regimen listed on the orders.
B7.2.1.4 Prior to administration of chemotherapy, two (2) persons qualified to administer chemotherapy shall verify and document the drug and dose in the bag or pill against the orders and the protocol, and the identity of the patient to receive the chemotherapy.
B7.2.2 There shall be a policy addressing safe administration of radiation therapy.
B7.2.2.1 There shall be a consultation with a radiation oncologist prior to initiation of therapy if radiation treatment is used in the preparative regimen.
B7.2.2.2 The patient’s diagnosis, pre-existing co-morbid conditions, and proposed preparative regimen shall be made available to the consulting radiation oncologist in writing.
B7.2.2.3 A documented consultation by a radiation oncologist shall at a minimum address any prior radiation treatment the patient may have received and any other factors that may increase the toxicity of the radiation.
B7.2.2.4 The consultation shall also include radiation planning.
B7.2.2.5 Prior to administration of each dose of radiation therapy, the dose shall be verified and documented as per radiation therapy standards.
B7.2.2.6 A final report of the details of the radiation therapy administered shall be documented in the patient medical record.
B7.3 There shall be a policy addressing safe administration of extracorporeal photopheresis (ECP).
B7.3.1 There shall be a consultation with the facility that performs ECP prior to initiation of therapy.
B7.3.2 Before ECP is undertaken, there shall be a written order from a physician specifying, at a minimum, the patient’s diagnosis, proposed regimen, timing of the procedure, and any other factors that may affect the safe administration of ECP.
B7.3.3 A final report of the details of ECP administered, including an assessment of the response, shall be documented in the patient’s medical record.
B7.3.4 The ECP procedure shall be performed according to written standard operating procedures of the facility performing the procedure appropriate for the clinical condition of the patient.
B7.3.5 Outcomes, including adverse events, related to the administration of ECP to patients within the Clinical Program shall be analyzed annually.
B7.4 There shall be a policy addressing safe administration of cellular therapy products.
B7.4.1 There shall be a policy for determining the appropriate volume and the appropriate dose of red blood cells, cryoprotectants, and other additives.
B7.4.1.1 Cord blood units that have not been red cell reduced shall be diluted and/or washed.
B7.4.1.2 Cord blood units that have been red cell reduced should be diluted and/or washed.
B7.4.1.3 For double cord blood transplants, the first unit shall be administered safely prior to administration of the second unit.
B7.4.2 Two (2) qualified persons shall verify the identity of the recipient and the product and the order for administration prior to the administration of the cellular therapy product.
B8 CLINICAL RESEARCH
B8.1 If required by applicable laws and regulations, Clinical Programs shall have formal review of investigational treatment protocols and patient consent forms by a process that is approved by the appropriate governmental authority.
B8.1.1 Those Clinical Programs utilizing applicable investigational treatment protocols shall have in place a pharmacy equipped for research activities, including a process for tracking, inventory, and secured storage of investigational drugs.
B8.2 Documentation for all research protocols performed by the Clinical Program shall be maintained in accordance with institutional policies and applicable laws and regulations, including all audits; documentation of approval by the Institutional Review Board, Ethics Committee, or equivalent; correspondence with regulatory agencies; and any adverse outcomes.
B8.3 For clinical research, informed consent shall be obtained from each research subject or legally authorized representative, in language he or she can understand, and under circumstances that minimize the possibility of coercion or undue influence.
B8.3.1 The research subject shall be given the opportunity to ask questions and to have his/her questions answered to his/her satisfaction, and to withdraw from the research without prejudice.
B8.3.2 Informed consent for a research subject shall contain the following elements at a minimum and comply with applicable laws and regulations:
B8.3.2.1 An explanation of the research purposes, a description of the procedures to be followed, and the identification of experimental procedures.
B8.3.2.2 The expected duration of the subject’s participation.
B8.3.2.3 A description of the reasonably expected risks, discomforts, benefits to the subject or others, and alternative procedures.
B8.3.2.4 A statement of the extent to which confidentiality will be maintained.
B8.3.2.5 An explanation of the extent of compensation for injury.
B8.4 There shall be a process in place to address, as appropriate, the disclosure of any issues that may represent a conflict of interest in clinical research.
B9 DATA MANAGEMENT
B9.1 The Clinical Program shall collect all the data necessary to complete the Transplant Essential Data Forms of the CIBMTR or the Minimum Essential Data- A forms of the EBMT.
B10 RECORDS
B10.1 Clinical Program records related to quality control, personnel training and competency, facility maintenance, facility management, complaints, or other general facility issues shall be retained in accordance with applicable laws and \regulations, or a defined program or institution policy, unless otherwise specified in these Standards.
B10.1.1 Employee records shall be maintained in a confidential manner and as required by applicable laws and regulations.
B10.2 Patient and donor records including, but not limited to, consents and records of care, shall be maintained in a confidential manner as required by applicable laws and regulations for a minimum of ten (10) years after the administration of the cellular therapy product, or, if not known, ten (10) years after the date of the distribution, disposition, or expiration, whichever is latest.
B10.3 Research records shall be maintained in a confidential manner as required by applicable laws and regulations for a minimum of ten (10) years after the administration, distribution, disposition, or expiration of the cellular therapy product, whichever is latest.
B10.4 RECORDS IN CASE OF DIVIDED RESPONSIBILITY
B10.4.1 If two (2) or more facilities participate in the collection, processing, or administration of the cellular therapy product, the records of each facility shall show plainly the extent of its responsibility.
B10.4.2 The Clinical Program shall furnish to other facilities involved in the collection or processing of the cellular therapy product outcome data in so far as they concern the safety, purity, or potency of the cellular therapy product involved.
PART CM: MARROW COLLECTION FACILITY STANDARDS
CM1 General
CM2 Marrow Collection Facility
CM3 Personnel
CM4 Quality Management
CM5 Policies and Procedures
CM6 Allogeneic and Autologous Donor Evaluation and Management
CM7 Coding and Labeling of Cellular Therapy Products
CM8 Process Controls
CM9 Cellular Therapy Product Storage
CM10 Cellular Therapy Product Transportation and Shipping
CM11 Records
CM12 Direct Distribution to Clinical Program
PART CM: MARROW COLLECTION FACILITY STANDARDS
CM1 GENERAL
CM1.1 These Standards apply to the Marrow Collection Facility for collection activities of all cellular therapy products collected from living donors.
CM1.2 The Marrow Collection Facility shall use cell processing facilities that meet FACT-JACIE Standards with respect to their interactions with the Marrow Collection Facility.
CM1.3 The Marrow Collection Facility shall abide by all applicable laws and regulations.
CM1.3.1 The Marrow Collection Facility shall be licensed, registered, and/or accredited as required by the appropriate governmental authority for the activities performed.
CM1.4 For initial accreditation, the Marrow Collection Facility, including a Marrow Collection Facility Medical Director and at least one staff member, shall have been in place and performing cellular therapy product collections for at least twelve (12) months preceding accreditation.
CM1.4.1 A minimum of one (1) marrow collection procedure shall have been performed in the twelve (12) months preceding accreditation.
CM1.5 The Marrow Collection Facility shall perform a minimum average of one (1) marrow collection procedure per year within the accreditation cycle.
CM2 MARROW COLLECTION FACILITY
CM2.1 There shall be appropriate designated areas for collection of cellular therapy products, for the product collected, and for storage of supplies, reagents, and equipment.
CM2.1.1 The Marrow Collection Facility shall be divided into defined areas of adequate size to prevent improper labeling, mix-ups, contamination, or cross-contamination of cellular therapy products.
CM2.1.2 There shall be a process to control storage areas to prevent mix-ups, contamination, and cross-contamination of all products prior to release or distribution.
CM2.1.3 There shall be a process for confidential donor examination and evaluation.
CM2.2 The Marrow Collection Facility shall provide adequate lighting, ventilation, and access to sinks to prevent the introduction, transmission, or spread of communicable disease.
CM2.3 When using collection methods that may result in contamination or crosscontamination of cellular therapy products, critical environmental conditions shall be controlled where appropriate for temperature, humidity, ventilation, air quality, and surface contaminates.
CM2.4 Marrow Collection Facility parameters and environmental conditions shall be controlled to ensure the safety and comfort of patients, donors, and personnel.
CM2.5 The Marrow Collection Facility shall be maintained in a clean, sanitary, and orderly manner.
CM2.6 There shall be adequate equipment and materials for the procedures performed.
CM2.7 There shall be access to autologous and/or CMV-appropriate and irradiated blood products.
CM2.8 There shall be access to an intensive care unit and/or emergency services.
CM2.9 SAFETY REQUIREMENTS
CM2.9.1 The Marrow Collection Facility shall be operated in a manner designed to minimize the risks to the health and safety of employees, patients, donors, visitors, and volunteers.
CM2.9.2 The Marrow Collection Facility shall have a written safety manual that includes instructions for action in case of exposure to communicable disease or to chemical, biological, or radiological hazards, where applicable.
CM3 PERSONNEL
CM3.1 MARROW COLLECTION FACILITY MEDICAL DIRECTOR
CM3.1.1 There shall be a Marrow Collection Facility Medical Director who is a licensed physician with postgraduate training in cell collection and/or transplantation.
CM3.1.2 The Marrow Collection Facility Medical Director or designee shall be responsible for the following elements:
CM3.1.2.1 All technical procedures.
CM3.1.2.2 Performance of the collection procedure.
CM3.1.2.3 Supervision of staff.
CM3.1.2.4 Administrative operations.
CM3.1.2.5 The medical care of allogeneic and/or autologous donors undergoing marrow collection.
CM3.1.2.6 Pre-collection evaluation of allogeneic and/or autologous donors at the time of donation.
CM3.1.2.7 Care of any complications resulting from the collection procedure.
CM3.1.2.8 The Quality Management Program, including compliance with these Standards and other applicable laws and regulations.
CM3.1.3 The Marrow Collection Facility Medical Director shall have at least one year experience in cellular therapy product collection procedures.
CM3.1.3.1 The Marrow Collection Facility Medical Director shall have performed or supervised at least ten (10) marrow collection procedures within his/her career.
CM3.1.4 The Marrow Collection Facility Medical Director shall participate regularly in educational activities related to cellular therapy product collection and/or transplantation.
CM3.2 QUALITY MANAGEMENT SUPERVISOR
CM3.2.1 There shall be a Marrow Collection Facility Quality Management Supervisor approved by the Marrow Collection Facility Medical Director to establish and maintain systems to review, modify, and approve all policies and procedures intended to monitor compliance with these Standards and/or the performance of the Marrow Collection Facility.
CM3.2.2 The Marrow Collection Facility Quality Management Supervisor shall participate regularly in educational activities related to the field of cellular therapy, cell collection, and/or quality management.
CM3.3 STAFF
CM3.3.1 The Marrow Collection Facility shall have access to licensed health care professionals who are trained and competent in marrow collection.
CM3.3.2 There shall be adequate numbers of trained collection personnel available in the Marrow Collection Facility.
CM3.3.3 For Marrow Collection Facilities collecting cellular therapy products from pediatric donors, physicians and collection staff shall have documented training and experience in performing these procedures.
CM4 QUALITY MANAGEMENT
CM4.1 The Marrow Collection Facility shall comply with B4 if it operates independently of a Clinical Program.
CM5 POLICIES AND PROCEDURES
CM5.1 The Marrow Collection Facility shall establish and maintain policies and/or procedures addressing critical aspects of operations and management in addition to those required in CM4. These documents shall include all elements required by these Standards and shall address at a minimum:
CM5.1.1 Donor and recipient confidentiality.
CM5.1.2 Donor consent.
CM5.1.3 Donor treatment.
CM5.1.4 Donor screening.
CM5.1.5 Management of donors, including pediatric donors if applicable.
CM5.1.6 Cellular therapy product collection.
CM5.1.7 Labeling (including associated forms and samples).
CM5.1.8 Cellular therapy product expiration dates.
CM5.1.9 Cellular therapy product storage.
CM5.1.10 Release and exceptional release.
CM5.1.11 Transportation and shipping to include methods and conditions to be used for distribution to external facilities.
CM5.1.12 Critical equipment, reagent, and supply management.
CM5.2 The Marrow Collection Facility shall comply with B5.2 if it operates independently of a Clinical Program.
CM5.3 Standard Operating Procedures required in CM5.1 shall be sufficiently detailed and unambiguous to allow qualified technical staff to follow and complete the procedures successfully. Each individual procedure shall include:
CM5.3.1 A clearly written description of the objectives.
CM5.3.2 A description of equipment and supplies used.
CM5.3.3 Acceptable end-points and the range of expected results, where applicable.
CM5.3.4 A stepwise description of the procedure.
CM5.3.5 Reference to other Standard Operating Procedures or policies required to perform the procedure.
CM5.3.6 A reference section listing appropriate literature, if applicable.
CM5.3.7 Documented approval of each procedure by the Marrow Collection Facility Medical Director, as appropriate, prior to implementation and every two years thereafter.
CM5.3.8 Documented approval of each procedural modification by the Marrow Collection Facility Medical Director or designated physician prior to implementation.
CM5.3.9 A current version of orders, worksheets, reports, labels, and forms, where applicable.
CM5.4 Copies of Standard Operating Procedures relevant to processes being performed shall be readily available to the facility staff.
CM5.5 All personnel in the Marrow Collection Facility shall follow the Standard Operating Procedures related to their positions.
CM5.6 Review and/or training by a staff member shall be documented before the staff member is allowed to perform new and revised policies and procedures.
CM5.7 There shall be a process to address age-specific issues in the Standard Operating Procedures as appropriate.
CM6 ALLOGENEIC AND AUTOLOGOUS DONOR EVALUATION AND MANAGEMENT
CM6.1 There shall be written criteria for allogeneic and autologous donor evaluation and management by trained medical personnel.
CM6.2 ALLOGENEIC AND AUTOLOGOUS DONOR INFORMATION AND CONSENT FOR COLLECTION
CM6.2.1 The collection procedure shall be explained in terms the donor can understand, and shall include the following information at a minimum:
CM6.2.1.1 The risks and benefits of the procedure.
CM6.2.1.2 Tests and procedures performed on the donor to protect the health of the donor and the recipient.
CM6.2.1.3 The rights of the donor and parent of the donor who is a minor to review the results of such tests according to applicable laws and regulations.
CM6.2.1.4 Protection of medical information and confidentiality.
CM6.2.2 The donor shall have an opportunity to ask questions.
CM6.2.3 The donor shall have the right to refuse to donate.
CM6.2.3.1 The allogeneic donor shall be informed of the potential consequences to recipient of such refusal.
CM6.2.4 Donor informed consent for the cellular therapy product collection shall be obtained and documented by a licensed health care professional familiar with the collection procedure.
CM6.2.4.1 Informed consent from the allogeneic donor should be obtained by a licensed health care professional other than the intended recipient’s primary transplant physician.
CM6.2.5 In the case of a minor donor, informed consent shall be obtained from the donor’s parent or legal guardian in accordance with applicable laws and regulations and shall be documented.
CM6.2.6 The allogeneic donor shall give informed consent and authorization in advance to release the donor’s health information to the transplant physician and/or the recipient as appropriate.
CM6.2.7 Documentation of consent shall be available to the Marrow Collection Facility staff prior to the collection procedure.
CM6.3 ALLOGENEIC AND AUTOLOGOUS DONOR SUITABILITY FOR CELLULAR THERAPY PRODUCT COLLECTION
CM6.3.1 There shall be criteria and evaluation procedures in place to protect the safety of donors during the process of cellular therapy product collection.
CM6.3.1.1 The Marrow Collection Facility shall ensure that any abnormal findings are reported to the donor with documentation in the donor record of recommendations made for follow-up care.
CM6.3.1.2 Allogeneic donor suitability should be evaluated by a licensed health care professional who is not the primary transplant physician or health care professional overseeing care of the recipient.
CM6.3.1.3 Autologous donors shall be tested as required by applicable laws and regulations.
CM6.3.2 The risks of donation shall be evaluated and documented, including:
CM6.3.2.1 Anesthesia for marrow collection.
CM6.3.3 A pregnancy assessment shall be performed for all female donors with childbearing potential within seven (7) days preceding donor mobilization, cellular therapy product collection, or initiation of the recipient’s preparative regimen, whichever occurs earliest.
CM6.3.4 Laboratory testing of all donors shall be performed by a laboratory accredited, registered, or licensed in accordance with applicable laws and regulations using one or more donor screening tests approved or cleared by the governmental authority.
CM6.3.5 A donor advocate should be available to represent allogeneic donors who are minors or who are mentally incapacitated.
CM6.3.6 Collection from a donor who does not meet Clinical Program collection safety criteria shall require documentation of the rationale for his/her selection by the transplant physician. Collection staff shall document review of these donor safety issues.
CM6.3.7 Issues of donor health that pertain to the safety of the collection procedure shall be communicated in writing to the Collection Facility staff. Collection staff shall document review of these issues prior to collection.
CM6.3.8 There shall be a policy for follow-up of donors that includes routine management and the management of donation-associated adverse events.
CM6.3.9 Allogeneic donors and allogeneic recipients shall be tested for ABO group and Rh type using two independently collected samples. Discrepancies shall be resolved and documented prior to issue of the cellular therapy product.
CM6.3.10 A red cell antibody screen shall be performed on allogeneic recipients.
CM7 CODING AND LABELING OF CELLULAR THERAPY PRODUCTS
CM7.1 ISBT 128 CODING AND LABELING
CM7.1.1 Cellular therapy products shall be identified according to the proper name of the product, including appropriate modifiers and attributes, as defined in ISBT 128 Standard Terminology for Blood, Cellular Therapy, and Tissue Product Descriptions.
CM7.1.2 If the Marrow Collection Facility has not fully implemented ISBT 128 technology, an implementation plan for the usage of ISBT 128 coding and labeling shall be in place.
CM7.2 LABELING OPERATIONS
CM7.2.1 Labeling operations shall be conducted in a manner adequate to prevent mislabeling or misidentification of cellular therapy products and product samples.
CM7.2.2 The labeling operation for pre-printed labels shall include, at a minimum, the following controls:
CM7.2.2.1 Labels shall be held upon receipt from the manufacturer pending review and proofing against a copy or template approved by the Marrow Collection Facility Medical Director or designee to ensure accuracy regarding identity, content, and conformity.
CM7.2.2.2 Stocks of unused labels for different products shall be stored in a controlled manner to prevent errors.
CM7.2.2.3 Stocks of obsolete labels shall be destroyed.
CM7.2.3 Print-on-demand label systems shall be validated to ensure accuracy regarding identity, content, and conformity of labels to templates approved by the Marrow Collection Facility Medical Director or designee.
CM7.2.4 A system for label version control shall be employed.
CM7.2.4.1 Representative obsolete labels shall be archived for ten (10) years with inclusive dates of use or as defined by applicable
laws and regulations.
CM7.2.5 A system of checks in labeling procedures shall be used to prevent errors in transferring information to labels.
CM7.2.5.1 Cellular therapy products that are subsequently re-packaged into new containers shall be labeled with new labels before they are detached from the original container.
CM7.2.5.2 A controlled labeling procedure consistent with applicable law shall be defined and followed if container label information is transmitted electronically during a labeling process. This procedure shall include a verification step.
CM7.2.6 When the label has been affixed to the container, a sufficient area of the container shall remain uncovered to permit inspection of the contents.
CM7.2.7 The information entered on a container label shall be verified by at least two (2) staff members.
CM7.2.8 Labeling elements required by applicable laws and regulations shall be present.
CM7.2.9 All data fields on labels shall be completed.
CM7.2.10 All labeling shall be clear, legible, and completed using ink that is indelible to all relevant agents.
CM7.2.11 Labels affixed directly to a cellular therapy product bag shall be applied using appropriate materials as defined by the applicable regulatory authority.
CM7.2.12 The label shall be validated as reliable for storage under the conditions in use.
CM7.3 PRODUCT IDENTIFICATION
CM7.3.1 Each cellular therapy product shall be assigned a unique numeric or alphanumeric identifier by which it will be possible to trace any cellular therapy product to its donor and to all records describing the handling and final disposition of the product.
CM7.3.1.1 The cellular therapy product and donor and product samples shall be labeled with the same identifier.
CM7.3.1.2 If a single cellular therapy product is stored in more than one container, there shall be a system to identify each container.
CM7.3.2 Marrow Collection Facilities may designate an additional or supplementary unique numeric or alphanumeric identifier to the cellular
therapy product.
CM7.3.2.1 Supplementary identifiers shall not obscure the original identifier.
CM7.3.2.2 The facility associated with each identifier shall be noted on the label.
CM7.4 LABEL CONTENT
CM7.4.1 At the end of the cellular therapy product collection, the cellular therapy product label on the primary product container shall bear the information in the Cellular Therapy Product Labeling table in Appendix I.
CM7.4.2 Each label shall bear the appropriate biohazard and warning labels as found in the Circular of Information (COI) for the Use of Cellular Therapy Products, “Table 2. Biohazard and Warning Labels on Cellular Therapy Products Collected, Processed, and/or Administered in the United States.”
CM7.5 LABELING AT COMPLETION OF COLLECTION
CM7.5.1 Labeling at the end of collection shall occur before the cellular therapy product bag is removed from the proximity of the donor.
CM7.6 ACCOMPANYING DOCUMENTATION AT THE END OF COLLECTION
CM7.6.1 Cellular therapy products collected in or designated for use in the U.S. shall be accompanied by the elements listed in the Accompanying Documents at Distribution table in Appendix III at the time of distribution.
CM7.7 ADDITIONAL DOCUMENTATION AT OR IMMEDIATELY AFTER DISTRIBUTION
CM7.7.1 For cellular therapy products distributed before completion of donor eligibility determination, there shall be documentation that donor eligibility determination was completed during or after the use of the product.
CM8 PROCESS CONTROLS
CM8.1 Collection of cellular therapy products shall be performed according to written collection procedures.
CM8.2 There shall be a process for inventory control that encompasses equipment, reagents, supplies, and labels.
CM8.2.1 There shall be a system to uniquely identify and track and trace all critical equipment, reagents, supplies, and labels used in the collection
of cellular therapy products.
CM8.2.2 Each supply and reagent used to collect cellular therapy products shall be visually examined at receipt and prior to use for damage or evidence of contamination.
CM8.2.3 Supplies and reagents coming into contact with cellular therapy products during collection shall be sterile and of the appropriate grade for the intended use.
CM8.3 Equipment for the marrow collection procedure shall conform to applicable laws and regulations, where applicable.
CM8.4 There shall be written documentation of an interim assessment of donor suitability for the collection procedure performed by a qualified person immediately prior to each collection procedure.
CM8.4.1 There shall be peripheral blood count criteria to proceed with collection.
CM8.5 Before cell collection is undertaken, there shall be a written order from a physician specifying, at a minimum, timing and goals of collection.
CM8.6 General or regional anesthesia, if required, shall be performed or supervised by a licensed, specialist-certified anesthesiologist.
CM8.7 Administration of mobilization agents shall be under the supervision of a licensed health care professional experienced in their administration and management of complications in persons receiving these agents.
CM8.8 The Marrow Collection Facility shall utilize a process for assessing the quality of cellular therapy products to ensure their safety, viability, and integrity and to document that products meet predetermined release specifications. Results of all such assessments shall become part of the permanent record of the product collected.
CM8.8.1 Methods for collection shall include a process for controlling and monitoring the collection of cellular therapy products to ensure products meet predetermined release specifications.
CM8.8.2 Methods for collection shall employ procedures validated to result in acceptable cell viability and recovery.
CM8.9 Collection methods shall employ aseptic technique to ensure that cellular therapy products do not become contaminated during collection.
CM8.10 Collection methods for pediatric donors shall employ appropriate age and size adjustments to the procedures.
CM8.11 Cellular therapy products shall be packaged in a closed sterile transfer pack appropriate for blood or marrow products.
CM8.12 HPC, Marrow products shall be filtered to remove particulate material prior to final packaging, distribution, or administration using filters that are non-reactive with blood.
CM8.13 Records shall be made concurrently with each step of collection of each cellular therapy product in such a way that all steps may be accurately traced.
