Outline of requirements in FACT IEC Standards
| Topic . | Brief description of requirement . | Importance . |
|---|---|---|
| Organizational management | Integrated team | Established and qualified leadership, accountability, continuity in patient care, compliance with established protocols and procedures, and shared data for quality improvement. |
| Defined responsibilities among participating entities | Maintain chain of custody, protect product viability and integrity, and safeguard patient safety. | |
| Regulatory compliance | Practice in accordance with laws and regulations, conduct proper oversight of research on human subjects, and limit liability. | |
| Facilities | Adequate environmental parameters | Minimize infections and contamination of CT products; provide staff space for providing patient care and performing procedures; protect safety of patients, personnel, and volunteers; and maintain security. |
| Provisions for emergency or intensive care | Rapidly treat adverse events, provide multisystem support, coordinate timely transfers of care to knowledgeable providers. | |
| Access to pharmaceutical agents | Obtain urgently needed and specialty drugs not routinely available. | |
| Equipment, supplies, and reagents | Obtain appropriate equipment and materials to collect, store, and process CT products and prepare products for patient administration. | |
| Personnel | Education and experience | Knowledge and training regarding applicable disease and cellular therapies and continuing education to maintain current knowledge. |
| Defined responsibilities | Provide leadership and oversight, designate critical activities, and secure medical coverage appropriate for the patient case mix. | |
| Adequate staffing | Effectively manage the number and severity of patients and provide the necessary consultants and support services. | |
| Quality management and policies and standard operating procedures | Process control | Use of adequate vendors and materials, establish standardized protocols and procedures, orderly creation of documents and records, CT product tracking and tracing via the chain of custody and recordkeeping, and continuous operations. |
| Data collection and reporting | Evaluation of safety end points and clinical outcomes. | |
| Continuous improvement | Assess the results of protocols, verify compliance with established procedures, recognize problems, detect trends requiring corrective action, manage occurrences, and report them as required. | |
| Staff development | Monitor performance of staff, provide training, and retraining. | |
| Donor evaluation and management | Donor selection | Written criteria for appropriate selection of donors, availability of allogeneic donor advocate when appropriate, testing for HLA and ABO/Rh type when appropriate, determine allogeneic donor eligibility in accordance with applicable laws and regulations, obtain clinically relevant data regarding CT products obtained from third party. |
| Informed consent for donation and collection process | Inform donor of risks and benefits of collection procedure thoroughly and in terms donor can understand, allow the opportunity to ask questions, and the right to refuse or withdraw. | |
| Donor safety | Determine medical fitness to undergo collection procedure, identify conditions requiring adjustments to collection procedure or follow-up care, write the order of timing and goals of collection, and manage collection-associated adverse events. | |
| CT product labeling | Labeling operations | Accurate labeling and identification of CT products, product samples, and associated records; verify the labels contain the necessary fields in the proper format. |
| Label content | Verify correct information entered onto label; comply with regulatory requirements for labeling; add information legibly with materials safe for CT products and reliable under the storage conditions in use. | |
| Process controls and equipment, supplies, and reagents | Inventory control | Use equipment, supplies, and reagents before expiration; verify that these materials are not damaged or contaminated; use sterile supplies and reagents of the appropriate grade for the intended use; calibrate equipment; and maintain an adequate CT product inventory to link products to the correct donor and recipient. |
| CT product specifications | Validation of documented and reproducible procedures; verify products meet predetermined specifications; document each step in CT product collection, distribution, processing, storage, and administration in records; use of GTPs and GMPs appropriate for the degree of manufacturing; and retention of product samples for future investigation. | |
| CT product testing | Establish appropriate controls, accurately link test samples to patient and CT product, validate testing procedures, use of external laboratories that are appropriately certified, licensed, or accredited; | |
| Allogeneic donor eligibility | Verify eligibility of cell donor in accordance with laws and regulations; obtain appropriate consent; and document urgent medical need when ineligible or eligibility determination is not complete. | |
| Storage | Conditions for storage | Maintain CT product viability and integrity throughout the duration of short-and long-term storage. |
| Product safety | Prevent contamination or cross-contamination; quarantine products with positive or incomplete infectious disease testing results; monitor storage temperature and set alarms appropriately. | |
| CT product stability | Verify CT product viability and integrity over time. | |
| Transportation and shipping | Transportation and shipping | Maintain a defined temperature range; protect products from conditions incident to handling; protect integrity of CT product and individuals in the immediate area of the product; accompany product with appropriate records; and maintain the chain of custody. |
| Product safety | Limit transit time, arrange alternative transportation in case of emergencies, and protect products from X-ray irradiation devices. | |
| Distribution and receipt | Release criteria | Record review before release, authorize the release of CT products that do not meet release criteria, obtain consent from the recipient’s physician, and visually inspect the product. |
| Chain of custody | Establish and maintain written records of CT product distribution and all individuals and entities responsible for each exchange of custody, document delay, or problems during distribution. | |
| Receipt of cellular-therapy products | Inspect products for integrity, evidence of mishandling or contamination, and appropriate labeling; verify appropriate temperature throughout transportation and shipping; review and verify specifications provided by the manufacturer; maintain product quarantine until release criteria are verified; verify evidence of donor eligibility in accordance with laws and regulations. | |
| Disposal | Agreements | Establish policies for the duration and conditions of storage and indications for disposal, obtain agreement before collection, and provide option to transfer CT product after agreed-upon storage interval. |
| Documentation of no further need | Obtain approval from the Medical Director or recipient’s physician before discard, use the method of disposal, and decontamination that meets laws and regulations. | |
| Recipient care | Informed consent for cellular therapy | Inform CT recipients of risks and benefits of therapy. |
| Safe administration of preparative regimens/conditioning agents | Include patient height and weight, dates of administration, doses, and route of administration in written order and standardize regimens. | |
| Safe administration of cellular-therapy products | Consult with the referring physician before initiation of therapy; verify identity of recipient, product, and written order; document in medical record the product unique identifier, initiation and completion times of administration, and any adverse events; provide to staff a circular of information for cellular products, including handling instructions, indications, and contraindications. | |
| Recipient monitoring and follow-up | Establish a written plan for the rapid escalation of care and relevant workup to address complications, establish written guidelines for the management of complications, regularly assess recipients to detect complications, and communicate timely with other clinical departments. | |
| Clinical research | Formal oversight | Review of investigational treatment protocols, patient consent forms, and documentation for all research protocols. |
| Formal processes | Use of pharmacy equipped for research activities; process for tracking, inventory, and secured storage of investigational drugs; process to manage investigational CT products; disclose conflicts of interest. | |
| Informed consent | Explanation of research trial’s risks, benefits, duration, compensation for injury, and confidentiality; allow recipients to ask questions and withdraw without prejudice. | |
| Data management | Data collection | Define staff responsible for collecting data, report data to institutional repositories as required, should report to the Center for International Blood and Marrow Transplant Research. |
| Records | Creation and maintenance | Concurrent recordkeeping and retention of records in accordance with standards and applicable laws and regulations, furnish outcome data to other facilities involved in the collection or processing of CT products, and validate electronic record systems. |
| Topic . | Brief description of requirement . | Importance . |
|---|---|---|
| Organizational management | Integrated team | Established and qualified leadership, accountability, continuity in patient care, compliance with established protocols and procedures, and shared data for quality improvement. |
| Defined responsibilities among participating entities | Maintain chain of custody, protect product viability and integrity, and safeguard patient safety. | |
| Regulatory compliance | Practice in accordance with laws and regulations, conduct proper oversight of research on human subjects, and limit liability. | |
| Facilities | Adequate environmental parameters | Minimize infections and contamination of CT products; provide staff space for providing patient care and performing procedures; protect safety of patients, personnel, and volunteers; and maintain security. |
| Provisions for emergency or intensive care | Rapidly treat adverse events, provide multisystem support, coordinate timely transfers of care to knowledgeable providers. | |
| Access to pharmaceutical agents | Obtain urgently needed and specialty drugs not routinely available. | |
| Equipment, supplies, and reagents | Obtain appropriate equipment and materials to collect, store, and process CT products and prepare products for patient administration. | |
| Personnel | Education and experience | Knowledge and training regarding applicable disease and cellular therapies and continuing education to maintain current knowledge. |
| Defined responsibilities | Provide leadership and oversight, designate critical activities, and secure medical coverage appropriate for the patient case mix. | |
| Adequate staffing | Effectively manage the number and severity of patients and provide the necessary consultants and support services. | |
| Quality management and policies and standard operating procedures | Process control | Use of adequate vendors and materials, establish standardized protocols and procedures, orderly creation of documents and records, CT product tracking and tracing via the chain of custody and recordkeeping, and continuous operations. |
| Data collection and reporting | Evaluation of safety end points and clinical outcomes. | |
| Continuous improvement | Assess the results of protocols, verify compliance with established procedures, recognize problems, detect trends requiring corrective action, manage occurrences, and report them as required. | |
| Staff development | Monitor performance of staff, provide training, and retraining. | |
| Donor evaluation and management | Donor selection | Written criteria for appropriate selection of donors, availability of allogeneic donor advocate when appropriate, testing for HLA and ABO/Rh type when appropriate, determine allogeneic donor eligibility in accordance with applicable laws and regulations, obtain clinically relevant data regarding CT products obtained from third party. |
| Informed consent for donation and collection process | Inform donor of risks and benefits of collection procedure thoroughly and in terms donor can understand, allow the opportunity to ask questions, and the right to refuse or withdraw. | |
| Donor safety | Determine medical fitness to undergo collection procedure, identify conditions requiring adjustments to collection procedure or follow-up care, write the order of timing and goals of collection, and manage collection-associated adverse events. | |
| CT product labeling | Labeling operations | Accurate labeling and identification of CT products, product samples, and associated records; verify the labels contain the necessary fields in the proper format. |
| Label content | Verify correct information entered onto label; comply with regulatory requirements for labeling; add information legibly with materials safe for CT products and reliable under the storage conditions in use. | |
| Process controls and equipment, supplies, and reagents | Inventory control | Use equipment, supplies, and reagents before expiration; verify that these materials are not damaged or contaminated; use sterile supplies and reagents of the appropriate grade for the intended use; calibrate equipment; and maintain an adequate CT product inventory to link products to the correct donor and recipient. |
| CT product specifications | Validation of documented and reproducible procedures; verify products meet predetermined specifications; document each step in CT product collection, distribution, processing, storage, and administration in records; use of GTPs and GMPs appropriate for the degree of manufacturing; and retention of product samples for future investigation. | |
| CT product testing | Establish appropriate controls, accurately link test samples to patient and CT product, validate testing procedures, use of external laboratories that are appropriately certified, licensed, or accredited; | |
| Allogeneic donor eligibility | Verify eligibility of cell donor in accordance with laws and regulations; obtain appropriate consent; and document urgent medical need when ineligible or eligibility determination is not complete. | |
| Storage | Conditions for storage | Maintain CT product viability and integrity throughout the duration of short-and long-term storage. |
| Product safety | Prevent contamination or cross-contamination; quarantine products with positive or incomplete infectious disease testing results; monitor storage temperature and set alarms appropriately. | |
| CT product stability | Verify CT product viability and integrity over time. | |
| Transportation and shipping | Transportation and shipping | Maintain a defined temperature range; protect products from conditions incident to handling; protect integrity of CT product and individuals in the immediate area of the product; accompany product with appropriate records; and maintain the chain of custody. |
| Product safety | Limit transit time, arrange alternative transportation in case of emergencies, and protect products from X-ray irradiation devices. | |
| Distribution and receipt | Release criteria | Record review before release, authorize the release of CT products that do not meet release criteria, obtain consent from the recipient’s physician, and visually inspect the product. |
| Chain of custody | Establish and maintain written records of CT product distribution and all individuals and entities responsible for each exchange of custody, document delay, or problems during distribution. | |
| Receipt of cellular-therapy products | Inspect products for integrity, evidence of mishandling or contamination, and appropriate labeling; verify appropriate temperature throughout transportation and shipping; review and verify specifications provided by the manufacturer; maintain product quarantine until release criteria are verified; verify evidence of donor eligibility in accordance with laws and regulations. | |
| Disposal | Agreements | Establish policies for the duration and conditions of storage and indications for disposal, obtain agreement before collection, and provide option to transfer CT product after agreed-upon storage interval. |
| Documentation of no further need | Obtain approval from the Medical Director or recipient’s physician before discard, use the method of disposal, and decontamination that meets laws and regulations. | |
| Recipient care | Informed consent for cellular therapy | Inform CT recipients of risks and benefits of therapy. |
| Safe administration of preparative regimens/conditioning agents | Include patient height and weight, dates of administration, doses, and route of administration in written order and standardize regimens. | |
| Safe administration of cellular-therapy products | Consult with the referring physician before initiation of therapy; verify identity of recipient, product, and written order; document in medical record the product unique identifier, initiation and completion times of administration, and any adverse events; provide to staff a circular of information for cellular products, including handling instructions, indications, and contraindications. | |
| Recipient monitoring and follow-up | Establish a written plan for the rapid escalation of care and relevant workup to address complications, establish written guidelines for the management of complications, regularly assess recipients to detect complications, and communicate timely with other clinical departments. | |
| Clinical research | Formal oversight | Review of investigational treatment protocols, patient consent forms, and documentation for all research protocols. |
| Formal processes | Use of pharmacy equipped for research activities; process for tracking, inventory, and secured storage of investigational drugs; process to manage investigational CT products; disclose conflicts of interest. | |
| Informed consent | Explanation of research trial’s risks, benefits, duration, compensation for injury, and confidentiality; allow recipients to ask questions and withdraw without prejudice. | |
| Data management | Data collection | Define staff responsible for collecting data, report data to institutional repositories as required, should report to the Center for International Blood and Marrow Transplant Research. |
| Records | Creation and maintenance | Concurrent recordkeeping and retention of records in accordance with standards and applicable laws and regulations, furnish outcome data to other facilities involved in the collection or processing of CT products, and validate electronic record systems. |