As cellular therapies expand, accredited cellular therapy programs often become involved in the development, implementation, and performance of protocols and procedures for indications outside of hematological or malignant diseases. Accredited programs must meet the FACT Standards for these nontraditional therapies as they apply, regardless of the patient population served. The lines can become blurred when non-accredited services are also provided in the institution. While accredited Clinical Programs are expected to utilize collection and processing facilities that meet FACT Standards, the converse is not true. An accredited Apheresis Facility or Processing Facility may serve both accredited and non‐accredited clinical programs. A “clinical program” may be simply a medical service in your institution that is not part of your accredited transplant or immune effector cell program, such as neurology or nephrology.
This article will review the responsibilities of Clinical Programs, Collection Facilities, and Processing Facilities for analyzing outcomes of nontraditional cellular therapies. To start, let’s review the requirements for internal clinical outcome analysis. Standards exist in each part of the Standards (clinical, collection, and processing) and all are similar. They require that documentation and review of outcomes and efficacy are outlined in the Quality Management (QM) Plan and/or policies and procedures, that criteria are determined and reviewed at regular time intervals, and that both individual and aggregate data are evaluated for each type of cellular therapy product and recipient.
B/C/D4.7 The Quality Management Plan shall include, or summarize and reference, policies and Standard Operating Procedures for documentation and review of outcome analysis and cellular therapy product efficacy to verify that the procedures in use consistently provide a safe and effective product.
B/C/D4.7.1 Criteria for cellular therapy product safety, product efficacy, and the clinical outcome shall be determined and shall be reviewed at regular time intervals.
B/C/D4.7.2 Both individual cellular therapy product data and aggregate data for each type of cellular therapy product and recipient type shall be evaluated.
If the physicians of the FACT-accredited cellular therapy program have no responsibility for the evaluation or management of patients treated with a cellular therapy, the Clinical Program is not responsible for assessing the efficacy of that cellular therapy because it is administered outside of its control.
However, if the accredited program’s physicians are involved in management of these patients, the Clinical Program is responsible for all aspects of the cellular therapy, whether or not the patients are housed on the accredited program’s unit. If the physicians are involved in the management of these patients, the patients and products are considered part of the program and QM program.
If the patients are housed on the accredited Clinical Program’s unit but the programs’ physicians are not involved, this is essentially “renting space” and considered a “nonaccredited service” ‐ a cellular therapy program existing in the same institution but not under the FACT accreditation. This would not be part of the accredited program or its QM responsibilities.
If collection of nontraditional cellular therapy products is performed within a FACT-accredited Apheresis Collection Facility, the facility is responsible for treating them as it would any other product. All standards for collection apply, including written procedures; training; collection orders; parameters; end points of collection; labelling; transport and shipping; chain of identity/chain of custody; release criteria; and processes to prevent mix‐ups, contamination, or cross‐contamination.
As part of the accreditation process, FACT expects that all cellular therapy products collected be listed on the apheresis collection facility grid, regardless of whether the products ultimately went to the accredited Clinical Program or to patients on another service. If the Collection Facility cannot evaluate efficacy, it should at a minimum evaluate product quality by assessing some designated parameters; for example, achievement of collection goals, contamination rates (or lack thereof), proper product labeling and storage, and integrity of the product (e.g., bags are intact).
Measures of cellular therapy product efficacy may be the responsibility of the clinical teams, but the FACT-accredited Processing Facility is still responsible for providing a safe product. This includes all of the standard laboratory quality attributes: procedures; training; equipment maintenance and calibration; facility cleanliness; chain of identity/chain of custody; labeling; and prevention of mix‐ups, contamination, and cross‐contamination. If performing any processing or cryopreservation of the product, some measure of post‐processing recovery or post‐thaw viability might be used to assess product quality in addition to testing for bacterial or fungal contamination.
FACT would expect all of these cellular therapy products to be listed on the Processing Facility grid and incorporated into the QM plan and evaluated as any cellular therapy product.