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

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.

Roadmap for Starting an Outpatient Cellular Therapy Program

2022 ◽  
pp. 355-368
Author(s):  
Mariana Lucena ◽  
Katie S. Gatwood ◽  
Bipin N. Savani ◽  
Olalekan O. Oluwole
Keyword(s):  
Cellular Therapy ◽  
Therapy Program

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

2020 ◽  
Vol 26 (3) ◽  
pp. S372
Author(s):  
Leslie Smith ◽  
Megan Mikula ◽  
Joan Aaron ◽  
Deborah Kolakowski
Keyword(s):  
Cellular Therapy ◽  
Therapy Program

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

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

scholarly journals Transplantation and Cellular Therapy

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.

CISMET

2021 ◽  
Vol 17 (1) ◽  
pp. 1-24
Author(s):  
M. Mahmudul Hasan ◽  
George Kousiouris ◽  
Dimosthenis Anagnostopoulos ◽  
Teta Stamati ◽  
Peri Loucopoulos ◽  
...  
Keyword(s):  
Information System ◽  
System Development ◽  
Regulatory Compliance ◽  
Development Projects ◽  
Clear Understanding ◽  
The European Union ◽  
Regulatory Requirements ◽  
Information System Development ◽  
General Data Protection Regulation ◽  
Software Application

Compliance to regulatory requirements is a critical concern in information system development projects. Managing this aspect is increasingly challenging while failures impose costly consequence on the organizations world-wide. However, how a legislation may or may not affect information system development projects is often not easily identifiable due to lack of clear understanding and guidelines. This paper presents compliant information system development (CISMET) ontology, exploiting concepts from 21 existing ontologies (regarding regulatory compliance and information system development). The key findings are the six parent classes in the CISMET ontology describing the system development goals, services, process, activities, artifacts, and resources. Also, there are 26 sub classes and 21 class properties that describe various concepts and their relationships in regulatory compliant information system development. The General Data Protection Regulation (GDPR) of the European Union has been instantiated in the proposed framework to indicate how regulatory requirements compliance concepts are mapped to system development projects. Thus, involved stakeholders (information system researchers and system developers) may identify dependencies and actions needed with relation to various rules in the regulation and their link to the system elements through a relevant software application. The latter enables users to easily submit queries towards the backend ontology through a specialized front-end application that can aid in formulating and submitting these queries.

Clinical Response to Questions Regarding Outcomes and Therapy Efficacy

2010 ◽  
Vol 20 (3) ◽  
pp. 76-83 ◽  
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?”

Communication Disordered: Program Implementation in Long-Term Care

2016 ◽  
Vol 1 (15) ◽  
pp. 64-67
Author(s):  
George Barnes ◽  
Joseph Salemi
Keyword(s):  
Program Implementation ◽  
Long Term Care ◽  
Family Satisfaction ◽  
Regulatory Compliance ◽  
Care Staff ◽  
Term Care ◽  
Staff Members ◽  
Change Policy

The organizational structure of long-term care (LTC) facilities often removes the rehab department from the interdisciplinary work culture, inhibiting the speech-language pathologist's (SLP's) communication with the facility administration and limiting the SLP's influence when implementing clinical programs. The SLP then is unable to change policy or monitor the actions of the care staff. When the SLP asks staff members to follow protocols not yet accepted by facility policy, staff may be unable to respond due to confusing or conflicting protocol. The SLP needs to involve members of the facility administration in the policy-making process in order to create successful clinical programs. The SLP must overcome communication barriers by understanding the needs of the administration to explain how staff compliance with clinical goals improves quality of care, regulatory compliance, and patient-family satisfaction, and has the potential to enhance revenue for the facility. By taking this approach, the SLP has a greater opportunity to increase safety, independence, and quality of life for patients who otherwise may not receive access to the appropriate services.

To Tell or Not to Tell, That Is the Question

2006 ◽  
Vol 11 (3) ◽  
pp. 236-243 ◽  
Author(s):  
Knut Dalen
Keyword(s):  
Gender Differences ◽  
Ethics Education ◽  
Ethical Dilemmas ◽  
Continuous Process ◽  
Telephone Counseling ◽  
Counseling Service ◽  
Telephone Service

Ethical dilemmas encountered by psychologists have previously been studied in surveys and as formal ethical complaints. No previous publications have been found in which data from an ethics counseling telephone service for psychologists has been analyzed. The present study examines ethical dilemmas, as presented by members of the Norwegian Psychological Association calling the Ethics Telephone Counseling Service (ETCS) from 2001 through 2003. Psychologists seek counseling for a range of ethical dilemmas. Ethical dilemmas concerning confidentiality are those most commonly presented. Dilemmas concerning integrity are also fairly common, whereas dilemmas concerning competence are rarely presented. The study shows virtually no difference in frequency and nature of consultation based on how long a psychologist has been licensed. This study also shows only minor gender differences in the use of the ETCS. Possible implications for ethics education as a continuous process are discussed.

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