CLINICAL PROGRAM STANDARDS:
B1 GENERAL
B1.1 The Clinical Program consists of an integrated medical team housed in geographically contiguous or proximate space with a Clinical Program Director(s)
and common staff training, programs, protocols, and quality management systems.
B1.1.1 Clinical Programs that include non-contiguous institutions shall demonstrate common protocols, procedures, quality management
systems, and review of clinical results and evidence of regular interaction.
B1.2 The Clinical Program shall use cell collection and processing facilities that meet FACT-JACIE Standards with respect to their interactions with the Clinical Program.
B1.3 The Clinical Program shall abide by all applicable laws and regulations.
B1.3.1 The Clinical Program shall be licensed, registered, and/or accredited as required by the appropriate governmental authorities for the activities performed.
B1.4 For initial accreditation, a dedicated transplant team including a Clinical Program Director(s) and at least one other physician trained and/or experienced in cellular therapy and/or HPC transplantation shall have been in place for at least twelve (12) months preceding accreditation.
B1.5 If the Clinical Program requests accreditation for allogeneic HPC transplantation, a minimum of ten (10) new allogeneic patients shall have been transplanted during the twelve (12) month period immediately preceding program accreditation and a minimum average of ten (10) new allogeneic patients shall be transplanted per year within the accreditation cycle. A Clinical Program that is accredited for allogeneic transplantation will be considered to have met the numeric requirement for autologous transplantation.
B1.5.1 For Clinical Programs utilizing more than one clinical site and requesting accreditation for allogeneic HPC transplantation, a minimum of five (5)
new allogeneic patients shall have been transplanted at each site performing allogeneic transplants during the twelve (12) month period immediately preceding accreditation and a minimum average of five (5) new allogeneic patients shall be transplanted at each site performing allogeneic transplants per year within the accreditation cycle. A site that is accredited for allogeneic transplantation will be considered to have met
the numeric requirement for autologous transplantation.
B1.5.1.1 For clinical sites performing only autologous transplants, a minimum of five (5) new autologous patients shall have been transplanted at each site during the twelve (12) month period immediately preceding accreditation and a minimum average of five (5) new autologous patients shall be transplanted at each site per year within the accreditation cycle.
B1.5.2 A combined Clinical Program caring for pediatric and adult patients at the same site shall perform a minimum average of five (5) allogeneic HPC transplants for each population per year within the accreditation cycle.
B1.6 If the Clinical Program requests accreditation for only autologous HPC transplantation, a minimum of five (5) new recipients of autologous transplantation shall have been transplanted during the twelve (12) month period immediately preceding accreditation and a minimum average of five (5) new recipients of autologous transplantation shall be transplanted per year within the accreditation cycle.
B1.6.1 For Clinical Programs utilizing more than one clinical site and requesting accreditation for autologous HPC transplantation only, a minimum of five (5) new patients shall have been transplanted at each site during the twelve (12) month period immediately preceding accreditation and a minimum average of five (5) new patients shall be transplanted at each site per year within the accreditation cycle.
B1.6.2 A combined Clinical Program requesting accreditation for autologous HPC transplantation only and caring for pediatric and adult patients at the same site shall perform a minimum average of five (5) transplants for each population per year within the accreditation cycle.
B2 CLINICAL UNIT
B2.1 There shall be a designated inpatient unit of adequate space, design, and location that minimizes airborne microbial contamination.
B2.1.1 The inpatient program shall have an intensive care unit or equivalent coverage available.
B2.1.1.1 There shall be written guidelines for clear communication and prompt transfer during and ongoing monitoring of the transfer of patients to an intensive care unit or equivalent coverage.
B2.2 There shall be a designated area for outpatient care that protects the patient from transmission of infectious agents and allows, as necessary, for appropriate patient isolation; administration of intravenous fluids, medications, and/or blood products; and confidential donor examination and evaluation.
B2.2.1 Outpatient facilities shall have a plan for providing access to an intensive care unit or equivalent coverage for patients who may become critically ill.
B2.3 Facilities used by the Clinical Program shall be maintained in a clean, sanitary, and orderly manner.
B2.4 The following shall apply to both inpatient and outpatient care:
B2.4.1 There shall be provisions for prompt evaluation and treatment by a transplant attending physician available on a 24-hour basis.
B2.4.1.1 If general medical physicians provide inpatient-based care to transplant patients, there shall be a policy for their scope of care and afterhours coverage.
B2.4.2 There shall be a pharmacy providing 24-hour availability of medications needed for the care of transplant patients.
B2.4.3 There shall be access to renal support under the direction of nephrologists and trained personnel.
B2.4.4 There shall be 24-hour availability of autologous and/or CMV-appropriate and irradiated blood products needed for the care of transplant patients.
B2.4.5 The Clinical Program shall refer planned discharges to facilities and health care professionals adequate for post-transplant care.
B2.4.5.1 The Clinical Program shall provide or secure oversight of care that meets applicable standards.
B2.4.6 Clinical Programs performing allogeneic cell transplants shall use HLA testing laboratories appropriately accredited by the American Society for Histocompatibility and Immunogenetics (ASHI), European Federation for Immunogenetics (EFI), or equivalent, with the capability of carrying out deoxyribonucleic acid (DNA)–based HLA-typing.
B2.5 SAFETY REQUIREMENTS
B2.5.1 The Clinical Program shall be operated in a manner designed to minimize risks to the health and safety of employees, patients, donors, visitors, and volunteers.
B2.5.2 The Clinical Program 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.
B3 PERSONNEL
B3.1 CLINICAL PROGRAM DIRECTOR
B3.1.1 The Clinical Program Director shall be a physician appropriately licensed or certified to practice medicine in the jurisdiction in which the program is located who has achieved specialist certification in one or more of the following specialties: Hematology, Medical Oncology, Pediatric Immunology, or Pediatric Hematology/Oncology. Physicians trained prior to requirements for specialty training may serve as Clinical Program Director if they have documented experience in the field of HPC transplantation extending over ten (10) years.
B3.1.2 The Clinical Program Director shall have two (2) years of experience as an attending physician responsible for the direct clinical management of HPC transplant patients in the inpatient and outpatient settings.
B3.1.3 The Clinical Program Director shall be responsible for administrative and clinical operations, including compliance with these Standards and applicable laws and regulations.
B3.1.4 The Clinical Program Director shall be responsible for all elements of the design of the Clinical Program including quality management, the selection and care of patients and donors, cell collection, and processing, whether internal or contracted services.
B3.1.5 The Clinical Program Director shall have oversight of the medical care provided by all members of the Clinical Program including medical care provided by the physicians on the transplant team.
B3.1.5.1 The Clinical Program Director shall be responsible for verifying the knowledge and skills of the physicians and mid-level practitioners of the transplant team.
B3.1.6 The Clinical Program Director shall participate regularly in educational activities related to the field of HPC transplantation.
B3.2 ATTENDING PHYSICIANS
B3.2.1 Clinical Program attending physicians shall be appropriately licensed to practice medicine in the jurisdiction of the Clinical Program and should be specialist certified or trained in one of the following specialties: Hematology, Medical Oncology, Adult or Pediatric Immunology, or Pediatric Hematology/Oncology.
B3.2.2 Clinical Program attending physicians shall participate regularly in educational activities related to the field of HPC transplantation.
B3.3 CLINICAL TRANSPLANT TEAM
B3.3.1 Clinical Programs performing pediatric transplantation shall have a transplant team trained in the management of pediatric patients.
B3.3.2 Clinical Programs performing pediatric transplantation shall have at least one attending physician who has achieved specialist certification in Pediatric Hematology or Oncology or Pediatric Immunology. An attending physician may also serve as the Clinical Program Director, if appropriately credentialed.
B3.3.3 For Clinical Programs performing adult transplantation, there shall be at least one attending physician who has achieved specialist certification in Hematology, Medical Oncology, or Immunology. An attending physician may also serve as the Clinical Program Director, if appropriately credentialed.
B3.3.4 The Clinical Program shall have access to licensed physicians who are trained and competent in marrow collection and a marrow collection facility that meets these Standards.
B3.3.5 The Clinical Program shall have access to personnel who are trained and competent in cellular therapy product collection by apheresis and an apheresis collection facility that meets these Standards.
B3.4 TRAINING FOR CLINICAL PROGRAM DIRECTORS AND ATTENDING PHYSICIANS
B3.4.1 Attending physicians shall each have a total of one year of supervised training in the management of transplant patients in both inpatient and outpatient settings.
B3.4.2 Clinical training and competency shall include the management of:
B3.4.2.1 Autologous transplant patients for physicians in Clinical Programs requesting accreditation for autologous transplantation.
B3.4.2.2 Allogeneic transplant patients for physicians in Clinical Programs requesting accreditation for allogeneic transplantation.
B3.4.2.3 Both allogeneic and autologous transplant patients for physicians in Clinical Programs requesting accreditation for allogeneic and autologous transplantation.
B3.4.3 Clinical Program Directors and attending physicians in all Clinical Programs shall have received specific training and maintain competency in each of the following areas:
B3.4.3.1 Indications for HPC transplantation.
B3.4.3.2 Selection of appropriate patients and preparative regimens.
B3.4.3.3 Pre-transplant patient evaluation, including assessment of appropriate patient suitability and HPC adequacy with respect to collection.
B3.4.3.4 Donor and recipient informed consent.
B3.4.3.5 Administration of preparative regimens.
B3.4.3.6 Donor evaluation and management.
B3.4.3.7 Administration of growth factors for HPC mobilization and for post-transplant hematopoietic cell reconstitution.
B3.4.3.8 HPC product infusion and patient management.
B3.4.3.9 Management of neutropenic fever.
B3.4.3.10 Diagnosis and management of infectious and non-infectious pulmonary complications of transplantation.
B3.4.3.11 Diagnosis and management of fungal disease.
B3.4.3.12 Diagnosis and management of veno-occlusive disease of the liver.
B3.4.3.13 Management of thrombocytopenia and bleeding.
B3.4.3.14 Management of hemorrhagic cystitis.
B3.4.3.15 Management of mucositis, nausea, and vomiting.
B3.4.3.16 Management of pain.
B3.4.3.17 Palliative and end of life care.
B3.4.3.18 Diagnosis and management of HPC graft failure.
B3.4.3.19 Evaluation of post-transplant cellular therapy outcomes.
B3.4.3.20 Evaluation of late effects of allogeneic and autologous transplants, including cellular, pharmacologic, and radiation therapy.
B3.4.3.21 Documentation and reporting for patients on investigational protocols.
B3.4.3.22 Applicable regulations and reporting responsibilities for adverse events.
B3.4.4 Additional specific clinical training and competency required for physicians in Clinical Programs requesting accreditation for allogeneic HPC transplantation shall include:
B3.4.4.1 Identification, evaluation, and selection of HPC source, including use of donor registries.
B3.4.4.2 Donor eligibility determination.
B3.4.4.3 Methodology and implications of human leukocyte antigen (HLA) typing.
B3.4.4.4 Management of patients receiving ABO incompatible HPC products.
B3.4.4.5 Diagnosis and management of cytomegalovirus (CMV) infection and disease.
B3.4.4.6 Diagnosis and management of other viral infections in immunocompromised hosts.
B3.4.4.7 Diagnosis and management of acute and chronic graft versus host disease.
B3.4.4.8 Diagnosis and management of post-transplant immunodeficiencies.
B3.4.5 The attending physicians shall be knowledgeable in the following procedures:
B3.4.5.1 HPC processing.
B3.4.5.2 HPC cryopreservation.
B3.4.5.3 Marrow collection procedures.
B3.4.5.4 Apheresis collection procedures.
B3.4.5.5 Extracorporeal photopheresis for allogeneic transplants, if applicable.
B3.5 MID-LEVEL PRACTITIONERS (Physician Assistants, Nurse Practitioners, Advanced Practitioners)
B3.5.1 Mid-level practitioners shall be licensed to practice in the jurisdiction of the Clinical Program and shall be limited to the scope of practice of their licenses and within parameters of their training.
B3.5.2 Mid-level practitioners shall have received specific training and maintain competency in the transplant-related cognitive and procedural skills that they routinely practice. These skills shall be documented and may include but are not limited to those listed in B3.4.3.
B3.5.3 Mid-level practitioners shall participate regularly in educational activities related to the field of HPC transplantation.
B3.6 NURSES
B3.6.1 The Clinical Program shall have nurses formally trained and experienced in the management of patients receiving cellular therapy.
B3.6.2 A Clinical Program treating pediatric patients shall have nurses formally trained and experienced in the management of pediatric patients receiving cellular therapy.
B3.6.3 Training shall include:
B3.6.3.1 Hematology/oncology patient care, including an overview of the cellular therapy process.
B3.6.3.2 Administration of preparative regimens.
B3.6.3.3 Administration of blood products, growth factors, cellular therapy products, and other supportive therapies.
B3.6.3.4 Care interventions to manage transplant complications, including, but not limited to, neutropenic fever, infectious and noninfectious processes, mucositis, nausea and vomiting, and pain management.
B3.6.3.5 Recognition of cellular therapy complications and emergencies requiring rapid notification of the clinical transplant team.
B3.6.3.6 Palliative and end of life care.
B3.6.4 There shall be written policies for all relevant nursing procedures, including, but not limited to:
B3.6.4.1 Care of immunocompromised patients.
B3.6.4.2 Administration of preparative regimens.
B3.6.4.3 Administration of cellular therapy products.
B3.6.4.4 Central venous access device care.
B3.6.4.5 Administration of blood products.
B3.6.5 There shall be an adequate number of nurses experienced in the care of transplant patients.
B3.6.6 There shall be a nurse/patient ratio satisfactory to manage the severity of the patients’ clinical status.
B3.7 CONSULTING SPECIALISTS
B3.7.1 The Clinical Program shall have access to certified or trained consulting specialists and/or specialist groups from key disciplines who are capable of assisting in the management of patients requiring medical care, including but not limited to:
B3.7.1.1 Surgery.
B3.7.1.2 Pulmonary medicine.
B3.7.1.3 Intensive care.
B3.7.1.4 Gastroenterology.
B3.7.1.5 Nephrology.
B3.7.1.6 Infectious diseases.
B3.7.1.7 Cardiology.
B3.7.1.8 Pathology.
B3.7.1.9 Psychiatry.
B3.7.1.10 Radiology.
B3.7.1.11 Radiation oncology with experience in large-field (e.g., total body or total lymphoid) irradiation treatment protocols, if radiation therapy is administered.
B3.7.1.12 Transfusion medicine.
B3.7.1.13 Neurology.
B3.7.1.14 Palliative and end of life care.
B3.7.2 A Clinical Program treating pediatric patients shall have consultants, as defined in B3.7.1, qualified to manage pediatric patients.
B3.8 QUALITY MANAGEMENT SUPERVISOR
B3.8.1 There should be a Clinical Program Quality Management Supervisor approved by the Program 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 Clinical Program.
B3.8.2 The Clinical Program Quality Management Supervisor shall participate regularly in educational activities related to the field of cellular therapy, and/or quality management.
B3.9 SUPPORT SERVICES STAFF
B3.9.1 The Clinical Program shall have one or more designated staff with appropriate training and education to assist in the provision of pretransplant patient evaluation, treatment, and post-transplant follow-up and care. Designated staff shall include:
B3.9.1.1 Pharmacy staff knowledgeable in the use and monitoring of pharmaceuticals used by the Clinical Program.
B3.9.1.2 Dietary staff capable of providing dietary consultation regarding the nutritional needs of the transplant recipient, including enteral and parenteral support, and appropriate dietary advice to avoid food-borne illness.
B3.9.1.3 Social Services staff.
B3.9.1.4 Psychology Services staff.
B3.9.1.5 Physical Therapy staff.
B3.9.1.6 Data Management staff sufficient to comply with B9.
B4 QUALITY MANAGEMENT
B4.1 There shall be an overall Quality Management Program that incorporates key performance data from clinical, collection, and processing facility quality management.
B4.1.1 The Clinical Program shall establish and maintain a written Quality Management Plan.
B4.2 The Quality Management Plan shall include an organizational chart of key personnel and functions within the cellular therapy program, including clinical, collection, and processing.
B4.2.1 The Quality Management Plan shall include a description of how these key personnel interact to implement the quality management activities.
B4.2.2 The Clinical Program Director or designee shall be responsible for the Quality Management Plan.
B4.2.2.1 The Clinical Program Director or designee shall have authority over and responsibility for ensuring that the Quality Management Program is effectively established and maintained.
B4.2.2.2 The Clinical Program Director or designee shall not have oversight of his/her own work if this person also performs other tasks in the Clinical Program.
B4.2.2.3 The Clinical Program Director or designee shall report on quality management activities, at a minimum, quarterly.
B4.2.2.4 The Clinical Program Director shall report on the performance of the Quality Management Plan, at a minimum, annually.
B4.3 The Quality Management Plan shall include, or summarize and reference, personnel education, experience, and training requirements for each key position in the Clinical Program. Personnel requirements shall include at a minimum:
B4.3.1 A system to document the following for all medical and nursing staff:
B4.3.1.1 Initial qualifications and training.
B4.3.1.2 Competency for each critical function performed.
B4.3.1.3 Continued competency at least annually.
B4.3.1.4 Annual performance review.
B4.3.1.5 Provisions for continuing education.
B4.3.2 A policy and/or procedure for personnel training and competency assessment.
B4.4 The Quality Management Plan shall include, or summarize and reference, policies and procedures for development, approval, implementation, review, revision, and archival of all critical processes, policies, and procedures.
B4.5 The Quality Management Plan shall include, or summarize and reference, a system for document control. The document control system shall include at a
minimum the following elements:
B4.5.1 Listing of all active critical documents that shall adhere to the document control system requirements.
B4.5.2 A procedure for preparation, approval, implementation, review, revision, and archival of all policies and procedures.
B4.5.2.1 Archived policies and procedures, the inclusive dates of use, and their historical sequence shall be maintained for a minimum of ten (10) years from archival or according to governmental or institutional policy, whichever is longer.
B4.5.3 A standardized format for policies, procedures, worksheets, and forms.
B4.5.4 Assignment of numeric or alphanumeric identifier and title to each document and document version regulated within the system.
B4.6 The Quality Management Plan shall include, or summarize and reference, policies and procedures for establishment and maintenance of written agreements with third parties whose services impact the clinical care of the patient and/or donor.
B4.6.1 Agreements shall include the responsibility of the third-party facility performing any step in collection, processing, or testing to comply with applicable laws and regulations and these Standards.
B4.6.2 Agreements shall be dated, reviewed, and renewed on a regular basis.
B4.7 The Quality Management Plan shall include, or summarize and reference, policies and procedures for documentation and review of outcome analysis and product efficacy, as appropriate.
B4.7.1 Review of outcome analysis and product efficacy shall include at a minimum:
B4.7.1.1 For HPC products intended for hematopoietic reconstitution, a process for documentation and review of time to engraftment following product administration.
B4.7.1.2 For HPC products, overall and treatment-related morbidity and mortality at 100 days and 1 year after transplantation.
B4.7.1.3 For other cellular therapy products, the criteria for product efficacy and/or the clinical outcome shall be determined and shall be reviewed at regular time intervals.
B4.7.2 The Clinical Program shall provide data on outcome analysis and product efficacy, including adverse events related to the patient and/or product, in a timely manner to entities involved in the collection, processing, and/or distribution of the cellular therapy product.
B4.8 The Quality Management Plan shall include, or summarize and reference, policies, procedures, and a timetable for conducting, reviewing, and reporting audits of the Clinical Program’s activities to verify compliance with elements of the Quality Management Program and operational policies and procedures.
B4.8.1 Audits shall be conducted on a regular basis by an individual with sufficient expertise to identify problems, but who is not solely responsible for the process being audited.
B4.8.2 The results of audits shall be used to recognize problems, detect trends, identify improvement opportunities, and implement corrective actions when necessary.
B4.8.3 The Clinical Program shall periodically audit at a minimum:
B4.8.3.1 Accuracy of data contained in the Transplant Essential Data Forms of the CIBMTR or the Minimum Essential Data-A Forms of the EBMT.
B4.8.3.2 Donor screening and testing.
B4.8.3.3 Verification of chemotherapy drug and dose against the orders and the protocol.
B4.8.3.4 Management of cellular therapy products with positive microbial culture results.
B4.8.4 Collection and analysis of data related to the audit shall be reviewed, reported, and documented, at a minimum, on an annual basis.
B4.9 The Quality Management Plan shall include, or summarize and reference, policies and procedures on the management of cellular therapy products with positive microbial culture results that address at a minimum:
B4.9.1 Notification of the recipient.
B4.9.2 Recipient follow-up and outcome analysis.
B4.9.3 Follow-up of the donor, if relevant.
B4.9.4 Reporting to regulatory agencies if appropriate.
B4.9.5 Criteria for the administration of cellular therapy products with positive microbial culture results.
B4.10 The Quality Management Plan shall include, or summarize and reference, policies and procedures for errors, accidents, adverse events, biological product deviations, and complaints.
B4.10.1 Policies and procedures shall include methods for:
B4.10.1.1 Detection.
B4.10.1.2 Investigation.
B4.10.1.3 Evaluation.
B4.10.1.4 Documentation.
B4.10.1.5 Reporting.
B4.10.1.6 Corrective action.
B4.10.1.7 Follow-up for effectiveness of corrective action.
B4.10.2 Documentation of each adverse event that occurs in the Clinical Program shall be reviewed in a timely manner by the Clinical Program Director.
B4.10.3 A written description of an adverse event shall be made available to the recipient’s and/or donor’s physician and the Collection and Processing Facilities, if appropriate.
B4.10.4 When applicable, adverse events shall be reported to the appropriate regulatory agencies within the required timeframes.
B4.10.5 Deviations from the following key Standard Operating Procedures,
B5.1.1, B5.1.5, and B5.1.6, shall be documented.
B4.10.5.1 Planned deviations shall be pre-approved by the Clinical Program Director or designee.
B4.10.5.2 Unplanned deviations and associated corrective actions shall be reviewed by the Clinical Program Director or designee.
B4.10.6 There shall be a defined process improvement plan that includes policies or procedures for the recognition and investigation of the cause of all issues that require corrective action.
B4.10.6.1 Follow-up activities shall be conducted to determine if the corrective actions were effective.
B4.10.7 There shall be a defined process to obtain feedback from patients and patient representatives.
B4.11 The Quality Management Plan shall include, or summarize and reference, policies and procedures for cellular therapy product tracking and tracing that allow tracking from the donor to the recipient or final disposition and tracing from the recipient or final disposition to the donor.
B4.12 The Quality Management Plan shall include, or summarize and reference, policies and procedures for actions to take in the event the Clinical Program’s operations are interrupted.
B4.13 The Quality Management Plan shall include, or summarize and reference, policies and procedures for qualification of critical reagents, supplies, equipment, and facilities used for the marrow collection procedure.
B4.14 The Quality Management Plan shall include, or summarize and reference, policies and procedures for validation and/or verification of the marrow collection procedure.
B4.14.1 Changes to the marrow collection procedure shall be verified or validated to determine whether they create an adverse impact
anywhere in the operation.
B5 POLICIES AND PROCEDURES
B5.1 The Clinical Program shall establish and maintain policies and/or procedures addressing critical aspects of operations and management in addition to those required in B4. These documents shall include all elements required by these Standards and shall address at a minimum:
B5.1.1 Donor and recipient evaluation, selection, and treatment.
B5.1.2 Donor and recipient consent.
B5.1.3 Donor and recipient confidentiality.
B5.1.4 Infection prevention and control.
B5.1.5 Administration of the preparative regimen.
B5.1.6 Administration of HPC and other cellular therapy products, including exceptional release.
B5.1.7 Administration of blood products.
B5.1.8 Facility management and monitoring.
B5.1.9 Disposal of medical and biohazard waste.
B5.1.10 Emergency and disaster plan, including the Clinical Program response.
B5.2 The Clinical Program shall maintain a detailed Standard Operating Procedures Manual.
B5.2.1 The Standard Operating Procedures Manual shall include a listing of all current Standard Operating Procedures.
B5.3 Standard Operating Procedures shall be sufficiently detailed and unambiguous to allow qualified staff to follow and complete the procedures successfully. Each individual procedure shall include:
B5.3.1 A clearly written description of the objectives.
B5.3.2 A description of equipment and supplies used.
B5.3.3 Acceptable end-points and the range of expected results, where applicable.
B5.3.4 A stepwise description of the procedure.
B5.3.5 Reference to other Standard Operating Procedures or policies required to perform the procedure.
B5.3.6 A reference section listing appropriate literature, if applicable.
B5.3.7 Documented approval of each procedure by the Clinical Program Director or designated physician prior to implementation and every two years thereafter.
B5.3.8 Documented approval of each procedural modification by the Clinical Program Director or designated physician prior to implementation.
B5.3.9 A current version of orders, worksheets, reports, labels, and forms, where applicable.
B5.4 Copies of Standard Operating Procedures relevant to processes being performed shall be readily available to the facility staff.
B5.5 All personnel in the facility shall follow the Standard Operating Procedures related to their positions.
B5.6 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.
B5.7 There shall be a process to address age-specific issues in the Standard Operating Procedures, as appropriate.
B6 ALLOGENEIC AND AUTOLOGOUS DONOR SELECTION, EVALUATION, AND MANAGEMENT
B6.1 There shall be written criteria for allogeneic and autologous donor selection, evaluation, and management by trained medical personnel.
B6.1.1 Written criteria shall include criteria for the selection of allogeneic donors who are minors.
B6.1.2 Written criteria shall include criteria for the selection of allogeneic donors when more than one donor is available and suitable.
B6.1.3 Information regarding the donation process should be provided to the potential allogeneic donor prior to HLA typing.
B6.2 ALLOGENEIC AND AUTOLOGOUS DONOR INFORMATION AND CONSENT TO DONATE
B6.2.1 The collection procedure shall be explained in terms the donor can understand, and shall include the following information at a minimum:
B6.2.1.1 The risks and benefits of the procedure.
B6.2.1.2 Tests and procedures performed on the donor to protect the
health of the donor and the recipient.
B6.2.1.3 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.
B6.2.1.4 Alternative collection methods.
B6.2.1.5 Protection of medical information and confidentiality.
B6.2.2 The donor shall have an opportunity to ask questions.
B6.2.3 The donor shall have the right to refuse to donate.
B6.2.3.1 The allogeneic donor shall be informed of the potential consequences to recipient of such refusal.
B6.2.4 Donor informed consent for the cellular therapy product donation shall be obtained and documented by a licensed health care professional familiar with the collection procedure.
B6.2.4.1 Informed consent from the allogeneic donor should be obtained by a licensed health care professional other than the intended recipient’s primary transplant physician.
B6.2.5 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.
B6.2.6 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.
B6.2.7 Documentation of consent shall be available to the Collection Facility staff prior to the collection procedure.
B6.3 ALLOGENEIC AND AUTOLOGOUS DONOR SUITABILITY FOR CELLULAR THERAPY PRODUCT COLLECTION
B6.3.1 There shall be criteria and evaluation procedures in place to protect the safety of donors during the process of cellular therapy product collection.
B6.3.1.1 Any abnormal finding shall be reported to the prospective donor with documentation in the donor record of recommendations made for follow-up care.
B6.3.1.2 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.
B6.3.1.3 Autologous donors shall be tested as required by applicable laws and regulations.
B6.3.2 The risks of donation shall be evaluated and documented, including:
B6.3.2.1 Possible need for central venous access.
B6.3.2.2 Mobilization therapy for collection of HPC, Apheresis.
B6.3.2.3 Anesthesia for collection of HPC, Marrow.
B6.3.3 The donor should be evaluated for the risk of hemoglobinopathy prior to administration of the mobilization regimen.
B6.3.4 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.
B6.3.5 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.
B6.3.5.1 The Clinical Program shall inform the Collection Facility and Processing Facility of donor test results or if any testing was not performed.
B6.3.6 A donor advocate should be available to represent allogeneic donors who are minors or who are mentally incapacitated.
B6.3.7 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.
B6.3.8 Issues of donor health that pertain to the safety of the collection procedure shall be communicated in writing to the Collection Facility staff.
B6.3.9 There shall be a policy for follow-up of donors that includes routine management and the management of collection-associated adverse events.
