Coach…Improve…Protect
Welcome to the Quality and Regulatory Services (QRS) resource guide! This guide is designed to assist with quality services for all Vitalant staff in achieving a pursuit of excellence. In this guide, you will find useful information about our services related to all aspects of quality to include; process improvement, safety, regulations, standards, policies, procedures, learning-development and training. Within this guide, you will also find contact information that will direct you to the applicable subject matter expert(s) based on your specific service needs.
Quality service is the key to customer satisfaction. We hope you find this guide helpful and inspiring.
“At Vitalant, you belong. Together, we lead with our hearts to find a better way!”
Process Design & Improvement Services
Clinical & Research Quality Services
Blood Services Division (BSD Quality Services
Quality System & Regulatory Services
Mary Beth Bassett
EVP Chief Quality Officer
mbbassett@vitalant.org
Robert Marriott
Gwen Jones
VP Clinical & Research Quality Services
VP Process Design & Improvement Services
rmarriott@vitalant.org
gjones@vitalant.org
Roxanne Tata
Patrick Ooley
VP Quality System & Regulatory Services
VP BSD Quality Services
pooley@vitalant.org
rtata@vitalant.org
The Quality and Regulatory Services team is the Source for Quality bringing concepts, processes and tools to help everyone in the organization understand their role in achieving excellence. The Source of Quality is the integration of the five elements (shown on the left- hand side) into our thinking, actions and building of a structure that supports Vitalant. These are the elements that are a part of a quality leading organization.
Click the image below to zoom definitions for the 5 elements
Coach…Improve…Protect
Coach: ❑ We teach quality principles and regulatory requirements. ❑ We provide consultation, guidance and are a resource for all things quality. ❑ We set up mechanisms for operations to solve their quality problems. Improve: ❑ We work with leaders and staff to foster continuous improvement, operational efficiency, productivity and innovation. ❑ We analyze quality and compliance data to drive change. ❑ We challenge the status quo while understanding the realities of the environments we work within. ❑ We provide a broad process view with enterprise-wide solutions that balance conflicting priorities to produce the best outcome. Protect: ❑ We identify standards for performance. ❑ We provide assurance for the quality of our products and services through our independent oversight. ❑ We create and manage systems (QMS) to maximize efficiency and effectiveness. ❑ We advise on the management of compliance risks.
Gwen Jones
VP Process Design and Improvement Services
gjones@vitalant.org
Dean Farnsworth
Jaime Estrada
Sr. Dir. Quality Analysis
Business Process Improvement Mgr.
dfarnsworth@vitalant.org
jestrada@vitalant.org
Nick Wettlaufer
Erin Stinson
Business Process Improvement Mgr.
Business Process Improvement Mgr.
estinson@vitalant.org
nwettlaufer@vitalant.org
Process Design & Improvement Services
Clinical & Research Quality Services
Blood Services Division (BSD Quality Services
Quality System & Regulatory Services
Process Design and Improvement Services
The Process Design and Improvement Services provide expertise in process design and re-design, problem solving and advanced quality data analysis across the organization with a focus on lean design and process efficiency.
Process Design and Improvement Services is comprised of the following service areas:
❑ Business Process Improvement ❑ Quality Data Analysis
Process Design and Improvement Services
organization.
Services provided include :
❑ Leading high impact improvement projects. ❑ Facilitating process transformation and mapping:
▪ Design and Redesign ▪ Waste and defects identification ▪ Define user requirements ▪ Create user acceptance test plans, cases and execution oversight ❑ Performing post improvement implementation business review to assess alignment with performance specifications. ❑ Conducting data analysis and performance sustainability monitoring.
❑ Training staff on:
▪ Huddles, Lead Measures, Basic Problem Solving and Change Management
Quality Data Analysis Services
support the organization’s needs
Services provided include :
❑ Delivering data-driven insights, actionable reports, presentations and recommendations to stakeholders. ❑ Identifying, prioritizing and collaborating with stakeholders and staff on problem solving and improvement opportunities.
❑ Initiating in-depth data analysis via Power BI, benchmarking and other reports.
❑ Assisting stakeholders with establishing lead and lag performance metrics.
❑ Conducting and assisting with report writing for on-going performance monitoring and sustainability.
❑ Collaborating with BPI managers and stakeholders to define business objectives, hypotheses and associated data analysis.
Patrick Ooley
VP BSD Quality Services
pooley@vitalant.org
Jennifer Szymanski
Jamie Buetow
Sr. Dir National Quality Source
Sr. Dir. National Quality - Mfg. HS
jszymanski@vitlant.org
jbuetow@vitalant.org
Trish Grace
Stephanie Carpenter
Sr. Dir Field Quality Territory 2
Sr. Dir Field Quality Territory 1
tgrace@vitalant.org
scarpenter@vitalant.org
Bryan Lovas
Sr. Dir. Env Health & Safety
blovas@vitalant.org
Process Design & Improvement Services
Clinical & Research Quality Services
Blood Services Division (BSD Quality Services
Quality System & Regulatory Services
Blood Services Division (BSD) Quality Services
BSD Quality Services provides support for blood center activities from blood collection through product delivery with a focus on product quality and donor safety.
Environmental, Health and Safety provides an enterprise-wide focus on employee safety.
Blood Services Division Quality Services is comprised of the following service areas:
❑ National Quality
Environmental Health and Safety
National Quality
helps ensure the quality of biological products through support of process development, critical reviews and data evaluation in functional areas, as well as the PlasmaSource division. The National Quality team is composed of specialists with an understanding of applicable regulations and requirements who provide support to national functional leaders and staff.
Services provided include:
❑ Supporting blood services functional initiatives.
❑ Participating in the design and approval of
processes and procedures.
❑ Analyzing data and identifying opportunities for
improvement at a functional level.
❑ Approving validation plans and results.
❑ Determining final disposition of non-conforming
products.
❑ Performing triage and training for deviation
management.
Field Quality
Field Quality helps ensure the quality of biological products through independent oversight. Staff proactively resolve operational quality issues through targeted improvement activities.
The Field Quality team is composed of generalists who provide support to divisional staff in all blood center disciplines.
Vitalant locations have been defined in two distinct territories of support.
Click map for a zoom view of territories
Services provided include:
❑ Supporting divisional leadership and staff on quality related issues.
❑ Coaching for improvement and problem solving.
❑ Performing quality risk assessments (internal audits).
❑ Leading root cause analysis activities.
❑ Facilitating external inspections and preparing inspection responses.
❑ Participating in and/or leading performance improvement initiatives.
Environmental Health and Safety
Environmental Health and Safety (EHS) provides programs designed to protect the health and safety of employees, the public, and the environment from hazards associated with the workplace.
The EHS team Services is composed of staff who serve as subject matter experts with an understanding of applicable regulations and requirements in their assigned functional area.
Services provided include :
❑ Development and implementation of environmental, employee safety and disaster programs.
❑ Monitoring fleet compliance.
❑ Monitoring metrics and outcomes related to employee and donor safety including employee illness and injury reporting.
❑ Supporting the VRI Bio-Safety program.
❑ Administration and monitoring of the EHS program using local safety officers.
Robert Marriott
VP Clinical & Research Quality Services
rmarriott@vitalant.org
Debbie Merritt
Tobie Kaufman
Clinical Svcs. Quality Admin Mgr.
Sr. Dir. RLTS Quality
dmerritt@vitalant.org
tkaufman@vitalant.org
Bill Ward
Tim Gehris
Sr. Dir. Biotherapies Quality
Sr. Dir. Research Quality
bward@vitalant.org
tgehris@vitalant.org
Process Design & Improvement Services
Clinical & Research Quality Services
Blood Services Division (BSD Quality Services
Quality System & Regulatory Services
Clinical and Research Quality Services
Clinical and Research Quality Services provides support for patient facing activities to include the delivery of test results, specialty delivery with a focus on product quality and donor safety. Clinical and Research Quality Services is comprised of the following service areas:
❑ Reference Laboratory and Transfusion Service
Clinical and Research Quality
Clinical and Research Quality delivers quality and regulatory support and services to operational areas that provide patient testing, direct patient care services, specialty cellular therapy products, and research activities.
The Clinical Services Quality team is composed of staff experienced in technical operations with an understanding of applicable regulations and requirements.
Services provided include:
❑ Supporting Clinical Services functional initiatives. ❑ Participating in the design and approval of processes and procedures. ❑ Approving validation plans and results. ❑ Determining final disposition of non-conforming products and testing. ❑ Deviation Management training, leading root cause analysis and approval of deviations. ❑ Analyzing data and identifying opportunities for improvement at a functional level. ❑ Coaching for improvement and problem solving. ❑ Facilitating external inspections, responses and manage relationships with accrediting agencies. ❑ Performing quality risk assessments (internal audits).
Roxanne Tata
VP Quality System and Regulatory Services
rtata@vitalant.org
Alana Sabin
Susanta Saha
Sr. Dir. Learning & Design
Sr. Dir. IS Qual & Comp.
Contact: rtata@vitalant.org
ssaha@vitalant.org
Kathleen Hopping
James Valentine
Sr. Dir. Regulatory Affairs
Sr. Dir. Quality Systems
khopping@vitalant.org
jvalentine@vitalant.org
Process Design & Improvement Services
Clinical & Research Quality Services
Blood Services Division (BSD Quality Services
Quality System & Regulatory Services
Quality System and Regulatory Services
Quality System and Regulatory Services provides centralized processes for quality management and regulatory functions, standardization, and regulatory compliance.
Quality System and Regulatory Services is comprised of the following service areas:
Quality Systems
Quality Systems helps manage the quality of products and services by providing an effective and efficient quality management system. Quality Systems develops quality programs and manages the document lifecycle from creation to archival. The Quality Systems team is composed of staff who serve as subject matter experts in their assigned area to provide expertise, guidance, and training for the QMS.
Services provided include:
❑ Designing, developing, implementing and evaluating the performance of the integrated quality management system. ❑ Establishing, maintaining and improving the processes used to operate the quality management system. ❑ Maintenance and administration of the QMS application. ❑ Developing and deploying the training to support quality programs. ❑ Developing and maintaining processes for document management.
Learning Design and Development
Learning Design and Development creates standardized learning programs and activities to help staff successfully perform their job.
The Learning Design and Development team is composed of staff who are learning design experts with an understanding of adult learning principles.
Services provided include:
❑ Developing training philosophy and guidelines.
❑ Designing, developing and implementing the organizational education/training programs. ❑ Determining the best modes and methods of training for effectiveness and efficiency. ❑ Performing on-going review to evaluate training material effectiveness, innovation and continuous improvement. ❑ Designing and deploying the approach for automated training assignments.
Information Systems Quality
Information System Quality (ISQ) provides assurance that all computerized systems follow the software development lifecycle, change control process and FDA guidelines and expectations. The ISQ team is composed of subject matter experts who serve as consultants/partners and provide oversight of all enterprise computerized systems.
Services provided include:
❑ Participation in change control activities for software applications, hardware and peripherals. ❑ Participation in the system design and risk assessment. ❑ Review and approval of validations. ❑ Advising on IT best practices for software/hardware and business applications. ❑ Guidance on medical device evaluations, data archive and data storage. ❑ Review and approval of technology and security events including analyzing data and identifying opportunities for improvement.
Regulatory Affairs
Regulatory Affairs ensures conformance to regulations and standards and is the regulatory resource for the organization. Regulatory Affairs serves as a liaison with regulators and develops regulatory submissions to support achievement of organizational strategies.
The Regulatory Affairs team is composed of staff that have regulatory and accreditation expertise in blood and biotherapies.
Services provided include:
❑ Developing and maintaining positive relationships with all regulatory and accrediting bodies/agencies. ❑ Managing and maintaining regulatory submissions for licensure and registration. ❑ Management of the Supplier Qualification Program. ❑ Designing, deploying and monitoring the Enterprise Records Management program. ❑ Support and oversight for the HIPAA/Privacy program.
Thank You! ~ QRS Leadership Team
Acknowledgements
This resource guide is the result of the hard work and dedication of many people who contributed their time, expertise, and feedback to make it a valuable tool for Vitalant. Thank you to the authors, reviewers, and editors who participated in the development for the publication of this guide. We are especially grateful to the following for their support and guidance: - The QRS staff who provide exceptional services to assist Vitalant in delivering products and services in a quality and efficient manner. - The Vitalant staff for all that they do, and for assisting the QRS team with understanding how we could be of a valuable service to you. We hope that this resource guide will provide assistance to you in your daily work activities, continuous improvement efforts and achieving your goals. Thank you for choosing us as your partner in quality services!
Process Design & Improvement Services
Clinical & Research Quality Services
Blood Services Division (BSD Quality Services
Quality System & Regulatory Services
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