Roadmap for Starting an Outpatient Cellular Therapy Program

Leveraging a software application to prepare for regulatory inspection within a hematopoietic cellular therapy program.

Journal of Clinical Oncology ◽

10.1200/jco.2017.35.8_suppl.142 ◽

2017 ◽

Vol 35 (8_suppl) ◽

pp. 142-142

Author(s):

Betsy Blunk ◽

Jesse Jawanda ◽

Kevin Drake ◽

Rocky Lee Billups ◽

Tonya Cox ◽

...

Keyword(s):

Cellular Therapy ◽

Continuous Process ◽

Regulatory Compliance ◽

Business Analytics ◽

Software Application ◽

Development Partner ◽

Therapy Program ◽

Inspection Process ◽

Cancer Network ◽

Assessment Questionnaire

142 Background: The Sarah Cannon Blood Cancer Network (SCBCN) is comprised of seven Hematopoietic Cellular Therapy (HCT) programs. Regulations require that programs have a consistent and continuous process to identify and measure compliance to ensure standards are met. Every 3 years, programs undergo inspections by the Foundation for the Accreditation of Cellular Therapy (FACT). Historically, programs would prepare for inspections by utilizing paper documents that support and demonstrate compliance with standards. The goal of this project was to develop an electronic platform to manage the FACT inspection. COMAIBA (Compliance Management Actionable Intelligence Business Analytics) was selected as a development partner. Methods: Within our HCT programs, a thorough analysis was performed to determine the current processes by which inspections took place. The FACT assessment questionnaire was reviewed and each standard was evaluated. Quality coordinators within the programs highlighted the key documentation necessary to meet each standard. Results: In collaboration with COMAIBA, a regulatory compliance module was developed which allows the programs to electronically prepare for and manage FACT inspections. There are currently over 1600 questions within the application broken down into clinical, apheresis, marrow collection and processing facility subsections. Programs upload supporting documentation to demonstrate how they comply with each standard. From a programmatic level, administrators and key personnel can, at any time, view the preparation process via a dashboard and view the compliance measures electronically. Conclusions: This electronic solution allows quality teams to proactively prepare for inspections and keep information current and up to date on an ongoing basis. As standards evolve, the design of the COMAIBA application allows versatility in updating and maintaining compliance. COMAIBA is working to utilize this format for other regulatory and accrediting bodies i.e. CoC, UNOS. In addition, allowing the inspectors to view information electronically prior to coming onsite may enhance the inspection process and allow for a more comprehensive review.

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To Infinity and Beyond: Developing a Nursing Cellular Therapy Program of Care

Biology of Blood and Marrow Transplantation ◽

10.1016/j.bbmt.2019.12.325 ◽

2020 ◽

Vol 26 (3) ◽

pp. S372

Author(s):

Leslie Smith ◽

Megan Mikula ◽

Joan Aaron ◽

Deborah Kolakowski

Keyword(s):

Cellular Therapy ◽

Therapy Program

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Collaborating for Successful Implementation of a Cellular Therapy Program: A Multi-Departmental Approach

Biology of Blood and Marrow Transplantation ◽

10.1016/j.bbmt.2018.12.628 ◽

2019 ◽

Vol 25 (3) ◽

pp. S418

Author(s):

Kathleen Ruehle ◽

Rebecca Stecher ◽

Kerry Mueller

Keyword(s):

Cellular Therapy ◽

Successful Implementation ◽

Therapy Program

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Transformative Leadership: A Model for Building a Comprehensive Cellular Therapy Program Partnership

Biology of Blood and Marrow Transplantation ◽

10.1016/j.bbmt.2019.12.332 ◽

2020 ◽

Vol 26 (3) ◽

pp. S367

Author(s):

Abby Castillo ◽

Amanda Brahim ◽

Melissa Hardwick ◽

Mary MacKrell ◽

Hugo Fernandez ◽

...

Keyword(s):

Cellular Therapy ◽

Transformative Leadership ◽

Therapy Program

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Transplantation and Cellular Therapy

10.1007/978-3-030-82052-7_13 ◽

2021 ◽

pp. 121-133

Author(s):

Navneet S. Majhail ◽

Marcos De Lima

Keyword(s):

Hematopoietic Cell Transplantation ◽

Cellular Therapy ◽

Hematologic Malignancies ◽

Cancer Center ◽

Medical Procedure ◽

Cell Therapies ◽

Care Services ◽

Therapy Program ◽

Cancer Services ◽

Quality Program

AbstractComprehensive cancer services include provision of care to patients with advanced hematologic malignancies, among whom some patients are candidates for hematopoietic cell transplantation (HCT). HCT is a complex and resource-intense medical procedure and optimal transplant outcomes require a high-functioning, multidisciplinary, and cohesive team. The presence of a successful HCT program reflects the commitment from a cancer center to provide comprehensive cancer care services. The program can also serve as a platform for performing cellular therapy procedures such as chimeric antigen receptor T-cell therapies. This chapter reviews the potential pathways to establish an HCT and cellular therapy program along with recommendations on the required infrastructure and personnel. In addition, the chapter provides the foundation for establishing a robust quality program and the resources required for data and research.

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Clinical Response to Questions Regarding Outcomes and Therapy Efficacy

Perspectives on Fluency and Fluency Disorders ◽

10.1044/ffd20.3.76 ◽

2010 ◽

Vol 20 (3) ◽

pp. 76-83 ◽

Cited By ~ 1

Author(s):

Joseph Donaher ◽

Tom Gurrister ◽

Irving Wollman ◽

Tim Mackesey ◽

Michelle L. Burnett

Keyword(s):

Risk Factors ◽

Clinical Response ◽

Speech Language Pathologists ◽

Specific Therapy ◽

Therapy Efficacy ◽

Therapy Program ◽

Adults Who Stutter ◽

Cure Rates

Parents of children who stutter and adults who stutter frequently ask speech-language pathologists to predict whether or not therapy will work. Even though research has explored risk-factors related to persistent stuttering, there remains no way to determine how an individual will react to a specific therapy program. This paper presents various clinicians’answers to the question, “What do you tell parents or adults who stutter when they ask about cure rates, outcomes, and therapy efficacy?”

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