Establishing a New Collection or Processing Facility at a FACT-Accredited Clinical Program
By Sarah Litel-Smith, BSMT (ASCP), FACT Accreditation Services Supervisor
FACT-accredited Clinical Programs are required to use Collection and Processing Facilities that meet FACT Standards with respect to their interactions with the program. A program with an opportunity to establish its own collection and/or processing facilities must ensure continued compliance with the Standards, including during the transition of operations to the new facility. As outlined in the Maintaining Accreditation Policy available on the FACT website, the accredited program will need to continue to use the currently accredited facility until the new facility is accredited or has demonstrated compliance with the FACT Standards.
A new Collection or Processing Facility is required to be established, in operation for 12 months, and perform the minimum number of procedures prior to accreditation. The application for accreditation can precede the 12 months of operation, provided key personnel, processes, validations, and documented staff training are in place for at least nine months before inspection.
The Clinical Program must notify FACT of the intention to use a new Collection or Processing Facility prior to its use and develop a transition plan. FACT will review the proposed transition plan to determine an appropriate percentage of patient products the new facility may collect or process for the program prior to achieving FACT accreditation.
The proposed transition plan should address the following, as well as each category outlined in the table below:
- Identification of key personnel, including a description of qualifications, relevant experience, education and training, and number of personnel.
- A description of the number and types of cellular therapy products to be collected or processed.
- A description of facility location, layout, and equipment.
- A description of the Quality Management Plan, completed qualifications, validations performed, and written policies and Standard Operating Procedures describing collection or processing processes.
- A plan to perform an initial assessment of three collected or processed patient products for yield and viability in comparison to products collected or processed by the currently accredited facility, and the plan to reassess patient products at pre-determined intervals.
- Assurance that the Clinical Program will continue to use the currently accredited collection or processing facility until the new facility is accredited or has demonstrated compliance with the FACT Standards.
- Timeline for the new facility becoming FACT accredited, and when FACT can expect progress reports regarding the transition.
TABLE: Steps for Establishing a New Collection or Processing Facility
| Step | Category | Action | Standards |
| 1 | Facilities | Identify the location of the Collection or Processing Facility, layout, and equipment. Ensure facilities include appropriate designated areas for activities, are of adequate size, and are suitable for the activities to be performed. | C2, D2 |
| 2 | Personnel | Hire key personnel. Ensure the Facility Director, Facility Medical Director, Quality Manager, and a minimum of one additional designated staff member are appropriately trained, qualified, and experienced. | C3, D3 |
| 3 | Equipment | Acquire required equipment and complete critical qualifications. | C8.2, D6.4 |
| 4 | Policies and Standard Operating Procedures: | Develop collection or processing Standard Operating Procedures. | C4, C5, D4, D5 |
| 5 | Quality Management | Create a Quality Management Plan and document control system. | C4, C5, D4, D5 |
| 6 | Validations | Perform an initial assessment of three collected or processed donor products for sterility, yield, and viability in comparison to products collected or processed by the currently accredited facility. | C4.14, D4.14 |
| The date of facility establishment is the date the first validation run is performed or later. | |||
| 7 | Notify FACT | Notify FACT of intention to add new Collection or Processing facility, and progress to date. | |
| 8 | Register | Register with the appropriate authorities. Register with ICCBBA, and implement and validate ISBT 128-compliant labels. | C1, D1
C7.4, D7.4 |
| 9 | Transition Plan | Submit a transition plan to FACT for review prior to collecting or processing patient products for administration at the new facility. The Clinical Program must continue to use the currently accredited facility until the new facility is accredited or has demonstrated compliance with the FACT Standards. | |
| FACT will review the plan and, if appropriate, approve a quantity of patient products to collect or process sufficient to maintain competency. The majority of products will be collected or processed at the accredited facility until the new facility is accredited or meets accreditation requirements | |||
| When multiple collections are planned, it is advisable to have one product collected or processed at the currently accredited facility and one at the new facility to compare engraftment, product dose, viability, and sterility results of each facility. If this is not possible, we recommend collecting or processing patients in cohorts of no more than three and evaluating engraftment, product dose, viability, and sterility of each cohort before starting another cohort. | |||
| 10 | Eligibility or Add-On Application | The new facility can begin an Eligibility or add-on application six months after establishment by submitting the request and an update on progress and completed Facility Grid. | |
| A new collection or processing facility is required to be established, in operation for 12 months, and perform the minimum number of procedures prior to accreditation. The application can precede the 12 months, but key personnel, processes, validations, and documented staff training in the collection or processing procedure(s) must be in place for a minimum of nine months before inspection. |
