CELLULAR THERAPY PRODUCT COLLECTION, PROCESSING, AND ADMINISTRATION DOCUMENT SUBMISSION REQUIREMENTS

Transcription

1 CELLULAR THERAPY PRODUCT COLLECTION, PROCESSING, AND ADMINISTRATION DOCUMENT SUBMISSION REQUIREMENTS FACT-JACIE International Standards for Cellular Therapy Product Collection, Processing and Administration, Fifth Edition Fifth Edition March 2012 FACT ACCREDITATION OFFICE University of Nebraska Medical Center Nebraska Medical Center Omaha, NE , USA Tel: (402) Fax: (402) COPYRIGHT 2012 Foundation for the Accreditation of Cellular Therapy (FACT)

2 CELLULAR THERAPY DOCUMENT SUBMISSION REQUIREMENTS Copies of the following items are required prior to the on-site inspection, and must be uploaded via the online Compliance Application within the FACTWeb Accreditation Portal. Do not use patient names on the documents submitted. If the primary language is other than English, the documents listed in Appendix I must be submitted in English or accompanied by an English translation. If your facility utilizes electronic records, hard copies of the primary source data must be assembled and flagged before the inspection, and must be ready for inspector review on-site. Those items not provided for inspector review by the end of the on-site inspection will be marked as a deficiency. For additional information, see the referenced standard and the accompanying information in the Accreditation Manual. TABLE OF CONTENTS Page Number Cellular Therapy Program Documentation 4 Clinical Program Documentation 4 Clinical Program Director 4 Training for Clinical Program Director 5 Attending Physicians 5 Training for Attending Physicians 5 Mid-Level Practitioners 6 Consulting Physicians 6 Clinical Quality Management Supervisor 6 Other Clinical Documentation 6 Marrow Collection Facility Documentation 7 Marrow Collection Facility Medical Director 7 Marrow Collection Facility Quality Management Supervisor 7 Other Marrow Documentation 8 Apheresis Collection Facility Documentation 8 Apheresis Collection Facility Director 8 Apheresis Collection Facility Medical Director 9 Apheresis Collection Facility Quality Management Supervisor 9 Other Apheresis Documentation 9 Documentation to be Available On Site 10 2

3 Processing Facility Documentation 10 Processing Facility Director 10 Processing Facility Medical Director 11 Processing Facility Quality Management Supervisor 11 Other Processing Documentation 11 Documentation to be Available On Site 12 Appendix I English Translation Requirements 13 3

4 CELLULAR THERAPY PROGRAM DOCUMENTATION General physical floor plan of all Program facilities (Clinical, Marrow Collection, Apheresis Collection, Processing). [B1.1] A map of the overall organization that includes all facilities. If facilities are not all located in the same building, include a campus map showing the locations of each. [B1.1] For Clinical Programs that include non-contiguous institutions, an organizational chart that illustrates interactions among all clinical sites. [B1.1.1] A copy of the certificate for each licensure, registration, and/or accreditation required by the appropriate governmental authorities. Include as appropriate: [B1.3.1] Validated FDA registration for Human Cells, Tissues, and Cellular and Tissue Based Products (Form 3356) or equivalent governmental registration. Certificates for accreditation of in-patient facilities such as the Joint Commission, American Osteopathic Association, Australian Council on Healthcare Standards, Canadian Council on Health Services Accreditation, or other certification required by the appropriate governmental authority. Other, if appropriate. For Programs requesting allogeneic transplantation accreditation, submit a copy of the HLA laboratory's current ASHI or EFI (or equivalent) accreditation certificate, including documentation of certification for DNA-based typing. For ASHI accreditation, also include the accreditation letter. [B2.4.6] CLINICAL PROGRAM DOCUMENTATION Clinical Program Director [B3.1] Copy of current Medical License or certificate. [B3.1.1] Curriculum vitae. [B3.1.1] Copy(ies) of specialty certification(s). [B3.1.1] or For non-board certified physicians who completed medical training before 1985, submit documentation of experience in the field of hematopoietic cell transplantation extending over ten (10) years, including the size and complexity of the program as well as the approximate number of transplant patients the person has managed. [B3.1.1] or Physicians who received all or part of their medical and specialty training outside of the United States or Canada must submit documentation of training and experience and a copy of any registration or certification in a relevant specialty. Letters from the directors of the referenced training programs should be obtained and should describe the specifics of the training received. [B3.1.1] Written confirmation of two years experience with direct clinical management of HPC transplants patients. The letter must include at least the following information: an estimate of the number of patients the applicant has managed, whether patient management included both inpatient and outpatient care, whether the experience was exclusively in autologous or allogeneic transplantation or if both autologous and allogeneic transplant recipients were represented and in what proportion, and an estimate of the actual number of weeks committed to this experience. The letter(s) may be from each of the directors of the programs, departments, and/or institutions where this experience 4

5 was obtained. If it is not possible to obtain letters from the directors where initial experience was gained, letters from directors at subsequent places of experience are acceptable. [B3.1.2] Documentation of the Clinical Program Director s regular participation in educational activities within the previous three years related to the field of hematopoietic progenitor cell transplantation. Include the following minimum information for each activity: [B3.1.6] Title of activity Type of activity (for example, webinar, meeting, grand round, etc.) Topic of activity (for example, hematology, cell transplantation, etc.) Date of activity Approximate number of hours of activity Training for Clinical Program Director [B3.4] Documentation of specific training and competency in the skills listed in Standard B For Programs requesting accreditation for allogeneic transplantation, documentation of specific training and competency in each of the skills listed in Standard B Documentation of knowledge in the skills listed in Standard B Attending Physicians [B3.2] (specify adult and pediatric programs if applicable): A copy of the current medical license or certification of each attending physician. [B3.2.1] Copy(ies) of specialty certification(s). [B3.2.1] or For non-board certified physicians who completed medical training before 1985, submit documentation of experience in the field of hematopoietic cell transplantation extending over ten (10) years, including the size and complexity of the program as well as the approximate number of transplant patients the person has managed. [B3.2.1] or Physicians who received all or part of their medical and specialty training outside of the United States or Canada must submit documentation of training and experience and a copy of any registration or certification in a relevant specialty. Letters from the directors of the referenced training programs should be obtained and should describe the specifics of the training received. [B3.2.1] Documentation of regular participation of each attending physician in educational activities within the previous three years related to the field of hematopoietic progenitor cell transplantation. Include the following minimum information for each activity: [B3.2.2] Title of activity Type of activity (for example, webinar, meeting, grand round, etc.) Topic of activity (for example, hematology, cell transplantation, etc.) Date of activity Approximate number of hours of activity Training for Attending Physicians [B3.4] Documentation of specific training and competency in the skills listed in Standard B3.4.3 for each attending physician. For Programs requesting accreditation for allogeneic transplantation, documentation of specific training and competency in each of the skills listed in Standard B3.4.4 for each attending physician. Documentation of knowledge in the skills listed in Standard B3.4.5 for each attending physician. 5

6 Mid-Level Practitioners [B3.5] A copy of national certification/license and/or state or provincial certification/license to practice as required in the jurisdiction of the Program for each mid-level practitioner. [B3.5.1] For each mid-level practitioner, documentation of training and competency in transplant related skills he/she routinely practices, including but not limited to skills listed in Standard B [B3.5.2] Documentation of regular participation of each mid-level practitioner in educational activities within the previous three years related to the field of hematopoietic progenitor cell transplantation, including the following minimum information for each activity: [B3.5.3] Title of activity Type of activity (for example, webinar, meeting, grand round, etc.) Topic of activity (for example, hematology, cell transplantation, etc.) Date of activity Approximate number of hours of activity Consulting Physicians [B3.7] Institutional credentialing department documentation for specialist certified or trained consulting physicians and/or physician groups OR a photocopy of board certification or documentation of training and experience for at least one (1) specialist in each specialty field. For programs that perform pediatric transplantation, documentation of specialist certification or training for consultants qualified to manage pediatric patients must be submitted. [B3.7] Peds Adult Surgery [B ] Intensive Care [B ] Nephrology [B ] Cardiology [B ] Psychiatry [B ] Radiation Oncology [B ] Neurology [B ] Peds Adult Pulmonary Medicine [B ] Gastroenterology [B ] Infectious Disease [B ] Pathology [B ] Radiology [B ] Transfusion Medicine [B ] Palliative and end of life care [B ] Clinical Quality Management Supervisor [B3.8.2] If applicable, documentation of regular participation of the Clinical Quality Management Supervisor in educational activities within the previous three years related to the field of the field of cellular therapy, and/or quality management, including the following minimum information for each activity: [B3.8.2] Title of activity Type of activity (for example, webinar, meeting, grand round, etc.) Topic of activity (for example, hematology, cell transplantation, etc.) Date of activity Approximate number of hours of activity Other Clinical Documentation Copy of the Clinical Program s Quality Management Plan. [B4.1.1] Copy of the organizational chart of key personnel and functions within the Clinical Program, including clinical, collection, and processing. [B4.2] Standard operating procedure for preparation, approval, implementation, review, revision, and archival of all policies and procedures (SOP for writing SOPs). [B4.5.2] Timetable of audits that includes audits already performed and audits planned for the future. [B4.8] Procedure for validation and/or verification of the marrow collection process. [B4.14] 6

7 Summary of one completed validation and/or verification study of the marrow collection procedure. [B4.14] Table of Contents from the Clinical Program Policy and Procedure Manual. [B5.1] Unsigned allogeneic and/or autologous consent forms or procedure for consenting to be a cellular therapy product donor. [B6.2.1] A complete patient list from the twelve months preceding submission of the Compliance Application (initial applicants) or from the start of the current accreditation cycle (renewal applicants). Include unique patient identifier, date of transplant, diagnosis, source of cells (marrow, peripheral blood, cord blood), type of transplant (autologous, allogeneic), type of patient (adult, pediatric), and CIBMTR ID (if applicable). Per United States HIPAA guidelines, do not include any direct identifiers including patient names. [B1.5, B1.6, and B9.1] Data Management Audit form (Available at > FACTWeb > Cellular Therapy Library). [B9.1] Applicable CIBMTR Data Management Forms for each sequential patient included on the Data Management Audit Form as follows [B9.1]: TED Only Centers and autologous patients or patients of international programs not submitted to CIBMTR: o Pre-Transplant Essential Data Form 2400 o 100-day Post-Transplant Essential Data Form 2450 Comprehensive Report Form Centers: o Pre-Transplant Essential Data Form 2400 o 100-day Post-Transplant Essential Data Form 2450 OR 100 Days Post-HSCT Data Form 2100 as applicable for each patient If needed, these forms can be found at > Data Management > Data Collection Forms. (Note: It is recognized that some patient characteristics may result in different CIBMTR forms than those listed above. If so, please contact the FACT office for further direction.) MARROW COLLECTION FACILITY DOCUMENTATION Marrow Collection Facility Medical Director Copy of current medical license or certificate. [CM3.1.1] Curriculum vitae. [CM3.1.1] Documentation of educational activities in which the Marrow Collection Facility Medical Director participated within the previous three years related to the field of cellular therapy product collection and/or transplantation. Include the following for each activity: [CM3.1.4] Title of activity Type of activity (for example, webinar, meeting, grand round, etc.) Topic of activity (for example, hematology, apheresis, etc.) Date of activity Approximate number of hours of activity Marrow Collection Facility Quality Management Supervisor Documentation of educational activities in which the Marrow Collection Facility Quality Management Supervisor participated within the previous three years related to the field of cellular therapy, cell collection, and/or quality management. Include the following for each activity: [CM3.2.2] 7

8 Title of activity Type of activity (for example, webinar, meeting, grand round, etc.) Topic of activity (for example, hematology, apheresis, etc.) Date of activity Approximate number of hours of activity Other Marrow Documentation If the marrow collection facility operates independently of a clinical program, a map of the overall organization that includes all facilities. [CM1.1] If the marrow collection facility operates independently of a clinical program, a physical floor plan of all facilities. [CM1.1] Certificate of licensure, registration, and/or accreditation required by the appropriate governmental authority for the activities performed. [CM1.3.1] For U.S. programs, include a copy of the validated FDA registration for Human Cells, Tissues, and Cellular and Tissue Based Products (Form 3356); for facilities in other countries, submit other certification required by the appropriate governmental authority. If the Marrow Collection Facility operates independently of the clinical program: [CM4.1] Copy of the Quality Management Plan. [B4.1.1] Copy of the organizational chart of key personnel and functions within the organization. [B4.2] Timetable of audits that includes audits already performed and audits planned for the future. [B4.8] Procedure for validation and/or verification of the marrow collection process. [B4.14] Summary of one completed validation and/or verification study of the marrow collection procedure. [B4.14] Table of Contents of the Marrow Collection Facility Policy and Procedure Manual if the Marrow Collection Facility operates independently of a clinical program.[cm5.1] Unsigned allogeneic and/or autologous consent forms or the procedure for consenting to be a cellular therapy product donor. [CM6.2.1] An SOP for labeling that includes application of biohazard and/or warning labels. [CM7.2.1] Completed example of each label used by the Marrow Collection Facility. [CM7.4.1] Use unique patient identifiers; do not use patient names. Primary collection container label, applied on completion of collection of products for allogeneic use. [Appendix I] Primary collection container label applied on completion of collection of products for autologous use. [Appendix I] Any partial labels applied by the Collection Facility. [Appendix I] Labels applied prior to transport or shipping of cellular therapy products, including inner and outer shipping labels, if applicable. [Appendices I and II] Documentation that accompanies the cellular therapy product at distribution or a procedure describing what is distributed with the product. [CM7.6] APHERESIS COLLECTION FACILITY DOCUMENTATION Apheresis Collection Facility Director 8

9 Curriculum vitae. [C3.1.1] Documentation of educational activities in which the Apheresis Collection Facility Director participated within the previous three years related to the field of cellular therapy product collection and/or transplantation. Include the following minimum information for each activity: [C3.1.4] Title of activity Type of activity (for example, webinar, meeting, grand round, etc.) Topic of activity (for example, hematology, apheresis, etc.) Date of activity Approximate number of hours of activity Apheresis Collection Facility Medical Director Copy of current medical license or certificate. [C3.2.1] Curriculum vitae. [C3.2.3] Documentation of educational activities in which the Apheresis Collection Facility Medical Director participated within the previous three years related to the field of cellular therapy product collection and/or transplantation. Include the following minimum information for each activity: [C3.2.4] Title of activity Type of activity (for example, webinar, meeting, grand round, etc.) Topic of activity (for example, hematology, apheresis, etc.) Date of activity Approximate number of hours of activity Apheresis Quality Management Supervisor Documentation of educational activities in which the Apheresis Collection Facility Quality Management Supervisor participated within the previous three years related to the field of cellular therapy, stem cell collection, and/or quality management. Include the following for each activity: [C3.3.2] Title of activity Type of activity (for example, webinar, meeting, grand round, etc.) Topic of activity (for example, hematology, apheresis, etc.) Date of activity Approximate number of hours of activity Other Apheresis Documentation For Apheresis Collection Facilities applying for FACT accreditation independently of a clinical program, a map of the overall organization that includes all facilities. [C1.1] If the facility is applying for FACT accreditation independently of a clinical program, physical floor plans of all facilities. [D1.1] Certificate of licensure, registration, and/or accreditation required by the appropriate governmental authority for the activities performed. [C1.3.1] U.S. facilities: A copy of the validated FDA registration for Human Cells, Tissues, and Cellular and Tissue Based Products (Form 3356) or equivalent governmental registration; for facilities in other countries, submit other certification required by the appropriate governmental authority. Copy of the Apheresis Collection Facilities Quality Management Plan(s). [C4.1] Copy of the organizational chart of key personnel and functions within the Apheresis Collection Facility [C4.2]. The Quality Management Plan and/or organizational chart may be included in the Clinical Quality Management Plan but must meet requirements found in C4. 9

10 Timetable of audits that includes audits already performed and audits planned for the future. [C4.8] A procedure for the validation of critical procedures. [C4.14] A summary of one completed validation study performed by the Apheresis Collection Facility [C4.14]. Standard operating procedure for preparation, approval, implementation, review, revision, and archival of all policies and procedures (SOP for writing SOPs). [C4.5.2] Table of Contents of the Apheresis Collection Facility Operating Procedure Manual. [C5.2] Unsigned allogeneic and/or autologous consent forms or the procedure for consenting to be a cellular therapy product donor. [C6.2.1] An SOP for labeling that includes application of biohazard and/or warning labels. [C7.2.1] Completed example of each label used by the Apheresis Collection Facility. [C7.4.1] Use unique patient identifiers; do not use patient names. Primary collection container label, applied on completion of collection of products for allogeneic use [Appendix I] Primary collection container label applied on completion of collection of products for autologous use [Appendix I] Any partial labels applied by the Collection Facility [Appendix I] Labels applied prior to transport of cellular therapy products, including inner and outer shipping labels, if applicable. [Appendices I and II] Documentation that accompanies the cellular therapy product at distribution or a procedure describing what is distributed with the product. [C7.6] Current list of critical electronic record systems in control of the Apheresis Collection Facility. [C11.6.1] Documentation to be Available On Site: For critical electronic record systems used for record keeping, documentation of validation of the system must be available on-site as well as a qualified individual to review the documentation with the inspector. Documentation should demonstrate compliance with the following FACT-JACIE Standards: Validated procedures for and documentation of: [C11.6.8] Training and continuing competency of personnel in the use of the system [C ] Monitoring of data integrity [C ] Back-up of the electronic records system on a regular schedule [C ] PROCESSING FACILITY DOCUMENTATION Processing Facility Director Curriculum vitae. [D3.1.1] Documentation of educational activities in which the Processing Facility Director participated within the previous three years related to the field of cellular processing and/or transplantation. Include the following for each activity: [D3.1.3] Title of activity Type of activity (for example, webinar, meeting, grand round, etc.) 10

11 Topic of activity (for example, hematology, cell processing, etc.) Date of activity Approximate number of hours of activity Processing Facility Medical Director Copy of current medical license or certification. [D3.2.1] Curriculum vitae. [D3.2.1] Documentation of educational activities in which the Processing Facility Medical Director participated within the previous three years related to the field of cellular processing and/or transplantation. Include the following for each activity: [D3.2.3] Title of activity Type of activity (for example, webinar, meeting, grand round, etc.) Topic of activity (for example, hematology, cell processing, etc.) Date of activity Approximate number of hours of activity Processing Facility Quality Management Supervisor Documentation of educational activities in which the Processing Facility Quality Management Supervisor participated within the previous three years related to the field of cellular processing and/or quality management. Include the following for each activity: [D3.3.2] Title of activity Type of activity (for example, webinar, meeting, grand round, etc.) Topic of activity (for example, hematology, cell processing, etc.) Date of activity Approximate number of hours of activity Other Processing Documentation For facilities applying for FACT accreditation independently of a clinical program, a map of the overall organization that includes all facilities. [D1.1] If the facility is applying for FACT accreditation independently of a clinical program, physical floor plans of all facilities. [D1.1] Documentation of licensure, registration, and/or accreditation required by the appropriate governmental authority for the activities performed. [D1.2.1] For U.S. facilities: A copy of the validated FDA registration for Human Cells, Tissues, and Cellular and Tissue Based Products (Form 3356); for facilities in other countries, submit other certification required by the appropriate governmental authority. Copy of the Processing Facility s Quality Management Plan. Include: [D4.1] Organizational chart of key personnel and functions within the Processing Facility. [D4.2] The Quality Management Plan and/or organizational chart may be included in the Clinical Quality Management Plan but must meet requirements found in D4. Timetable of audits that includes audits already performed and audits planned for the future. [D4.8] Summary of one completed validation study performed by the Processing Facility. [D4.14] Procedure for performing validations. [D4.14] Complete cryopreservation SOP(s) that includes the directions for cryopreservation including preparation of the cryoprotectant solution. [D5.1.6] 11

12 Table of Contents of the Processing Facility Standard Operating Procedures Manual. [D5.2] Procedure for preparation, approval, implementation, review, revision, and archival of all policies and procedures (SOP for writing SOPs). [D4.5.2] SOP for labeling that includes application of biohazard and/or warning labels. [D7.2.1] Completed example of each label used by the Processing Facility [D7.4.1]. Use unique patient identifiers; do not use patient names. Any partial labels applied by the Processing Facility. [Appendix I] Label applied at completion of processing of allogeneic products. [Appendix I] Label applied at completion of processing of autologous products. [Appendix I] Labels attached prior to distribution. [Appendix I] Labels applied prior to transport or shipping of cellular therapy products, including inner and outer shipping labels, if applicable. [Appendices I and II] Labels attached prior to distribution. [Appendix I] Documentation that accompanies the cellular therapy product at distribution or a procedure describing what is distributed with the product. [D7.8] If a document other than the current version of the inter-organizational Circular of Information for the Use of Cellular Therapy Products is used, the document made available to clinical staff with the following information: [D8.3.1] Use of the cellular therapy product, indications, contraindications, side effects and hazards, dosage, and administration recommendations. [D ] Handling the cellular therapy product to minimize the risk of contamination or crosscontamination. [D ] Appropriate warnings related to the prevention of the transmission or spread of communicable diseases, [D ] A pre-collection written agreement between the storage facility and the designated recipient or the donor. [D11.1.1] Current list of critical electronic record systems in control of the Processing Facility. [D12.2.1] Documentation to be Available On Site: If an electronic record system under the control of the facility is used for record keeping, documentation of validation of the system must be available on-site as well as a qualified individual to review the documentation with the inspector. Documentation should demonstrate compliance with the following FACT- JACIE Standards: Validated procedures for and documentation of: [D12.2.6] o Systems development [D ] o Numerical designation of system versions if applicable [D ] o Prospective validation of system including hardware, software, and databases [D ] o Installation of the system [D ] o Training and continuing competency of personnel in the use of the system [D ] o Monitoring of data integrity [D ] o Back-up of the electronic records system on a regular schedule [D ] o System maintenance and operations [D ] 12

13 APPENDIX I ENGLISH TRANSLATION REQUIREMENTS International inspection teams use English as the common language. If English is not the primary language of the cellular therapy program, the documents listed below must be submitted in English or accompanied by an English translation. FACT may require other translated documents in addition to this list as necessary to aid in the preinspection process. A copy of the Clinical Program s Quality Management Plan [B4], including the organizational chart of key personnel and functions within the program, including clinical, collection and processing. [B4.2] If the Marrow Collection Facility operates independently of a Clinical Program, a copy of the facility s Quality Management Plan(s) [CM4.1, B4], including the organizational chart of key personnel and functions within the facility [CM4.1, B4.2]. A copy of the Apheresis Collection Facility s Quality Management Plan(s) [C4], including the organizational chart of key positions, personnel, and functions within the facility [C4.2]. (The Quality Management Plan and/or organizational chart may be included in the Clinical Quality Management Plan but must meet requirements found in C4). A copy of the Processing Facility s Quality Management Plan [D4] that includes the organizational chart of key positions, personnel, and functions within the facility [D4.2]. (The Quality Management Plan and/or organizational chart may be included in the Clinical Quality Management Plan but must meet requirements found in D4.) Table of Contents from Policy and Procedure Manual(s) [B5.2, CM5.2, C5.2, D5.2]. SOP describing the process of writing SOPs [B4.5.2, CM4.1, C4.5.2, D4.5.2]. Unsigned allogeneic and/or autologous consent forms or procedure for consenting to be a cellular therapy product donor [B6.2.1], [CM6.2.1], [C6.2.1]. A pre-collection written agreement between the storage facility and the designated recipient or the donor. [D11.1.1] A validation or qualification procedure and a summary of one completed validation or qualification study of the marrow collection procedure, reagents, supplies, equipment, or facility [B4.13, B4.14, CM4.1]. A validation or qualification procedure and a summary of one completed validation or qualification study performed by the Apheresis Collection Facility. An example may be the validation or qualification of a process, a piece of equipment, reagent(s), or supplies used in the Apheresis Collection Facility [C4.13, C4.14]. A validation or qualification protocol and a summary of one completed validation or qualification study performed by the Processing Facility. An example may be the validation or qualification of a process, piece of equipment, reagent(s), or supplies used in the Processing Facility [D4.13, D4.14]. Complete cryopreservation SOP(s) that includes the directions for cryopreservation including preparation of the cryoprotectant solution [D5.1.6]. If a document other than the current version of the inter-organizational Circular of Information for the Use of Cellular Therapy Products (at is used at your facility, submit the document used. Instructions should include at least the following for each type of cellular therapy product distributed: use, indications, contraindications, side effects, hazards, dosage and administration recommendations, instructions to minimize contamination, warnings related to prevention of transmission of communicable diseases [B7.4.4, D8.3] 13