Document Development, Implementation, Review, Archive, and Disposal

The challenges in setting up a document management system are both technical and organizational. Both need to be addressed to achieve success. Time is required to make a thorough inventory of system requirements, whether electronic or paper-based, and to organize the team that will maintain the system. It is crucial that key stakeholders are involved from the beginning and that they see the value of the quality system in improving clinical care. Routine use by all staff will prevent it from being seen as a burdensome additional imposition due to the need for JACIE accreditation. When fully implemented, the documents and policies become a readily accessible, clinically relevant, educational resource that improves patient care.

Training Programme

Cell therapy is a complex field, with a plethora of therapeutic procedures that widely differ among and within countries. An effective and efficient quality management (QM) system is essential to ensure the safety of patients, donors, and medical personnel, and to ensure that all aspects of the cell therapy process from product select to infusion are safe. Risk minimisation requires all personnel involved in cell therapy to be familiar with the procedures as well as cooperate with personnel from other disciplines. Staff training plays a key role in the implementation of cell therapy and in QM. New cell therapy applications are constantly being developed. Appropriate training of personnel will improve both the effectiveness of cell therapy and patient survival.

Maintaining the Quality Management Program

AbstractsEstablishing and maintaining a quality management program (QMP) is easy in theory but difficult in practice. It requires considerable time, energy, and the full commitment of everyone involved, starting with the program management. The time involved in establishing a QMP varies in terms of time, depending on the scope of your system and the starting point. The initial question you need to ask is, “What standards, knowledge, do we already have?” In almost every case, the answer is “a considerable amount!” These days many hospitals already have accreditations or certifications like Joint Commission International (JCI), International Organization for Standardization (ISO), standards issued by the government and institutions and professional organizations. The most important pool of knowledge, however, is the education and experience of staff. All standards are initially created by colleagues in the field and, at least for FACT-JACIE, also further developed in a 3-year review cycle.

Correction to: Quality Management and Accreditation in Hematopoietic Stem Cell Transplantation and Cellular Therapy

John A. Snowden: From “Department of Haematology, University of Sheffield, Sheffield, UK”

Adverse Events and Corrective and Preventive Actions

Everything that is not compliant with SOP, guidelines, national and international standards, and legal requirements could affect the quality and safety of the cellular products and all processes. To guarantee the safety of cellular products, to protect recipients, donors, and personnel, it is necessary to have in place a robust system for reporting, investigating, and resolving all occurrences: errors, accidents, adverse events, biological product deviations, and complaints.In some case, the management of adverse events and other type of deviations is included in hospital management, but even in this case, the transplant programme quality system should have specific SOP that includes a system to manage any issues, actions to prevent adverse events and deviations, and a description of the step to resolve them.

Outcome Analysis

To understand and hence improve the positive impact of any healthcare activity, procedure or intervention, it is essential that there is an objective analysis of the activity, procedure or intervention based on predetermined standards.In the field of haematopoietic stem cell transplantation, outcome analysis is the process by which the results of a transplant procedure are formally assessed. It includes a series of reviews for evaluating the effectiveness of the health care provided and for identifying the most promising therapies and transplant approaches, given the available medical evidence and healthcare resources.Outcome analysis allows the transplant team to understand the effects of their practice and improve quality. Its relevance is due to transplant involving high treatment-related risk, significant practice variations, and continual practice developments – for example, recent developments in CAR-T and IEC therapies.The main aim of this chapter is to discuss how to find outcome data and how and when to present it. This will need to be adapted to the local programme.

Tracking and Traceability

The ability to trace a cellular product from donor to patient and vice versa is essential for the patient’s safety. Uniform product description as well as standardization of product labelling is necessary to ensure adequate tracking and tracing of cellular products.Also, with the increasing use of automated systems, accurate and unambiguous electronic transfer of product information is critical.Standardization comprises several elements which together will form an ‘information environment’. Together with electronic standards such as ISBT128 and Eurocode, this will further enhance safety, accuracy and efficiency in tracking and tracing cellular products.

The Accreditation Process

Achieving accredited status for hematopoietic cell transplantation (HCT) programme shows an ongoing commitment to the quality and safety of the services offered and of the activities performed. Accreditation is considered a standard through which a healthcare facility or service is shown to offer quality and healthcare that meet minimum standards and guidelines offered by different quality boards (at national and international levels). Among the most well-known accreditation agencies in the world are the Joint Commission and the Joint Commission on Accreditation of Healthcare Organizations (JC and JCAHO), the International Society for Quality in Health Care (ISQua), the Accreditation Commission for Health Care, Inc. (ACHC), the Healthcare Quality Association on Accreditation (HQAA) and, specifically for HCT programmes, the FACT and the JACIE.Any patient entering a healthcare facility wants and deserves to know that staff is trained and facilities are clean and well maintained and that procedures follow standards that reduce chances of error, infection or negligence.

Process Indicators

There are different tools to evaluate the efficacy of the system. Indicators are one of them. An indicator is a measure done in a critical point and the resulting value has to be within a pre-determined range. A deviation in the result of an indicator requires a study of the cause and an action to improve the system in that particular issue.

Audits

There are different tools to measure the efficacy of the quality system and of its processes. Among them, internal audits are essential components since they cover all aspects of the program. Auditing is a systematic and documented process to ensure compliance with requirements. Preparing and planning are important parts of a good audit and the selection of the auditor must be based on expertise and competency. The appropriate analysis of the results of the audit and implementation of the corrective action, preventive action, or process improvements after the audit will help the program to improve year after year.