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(9222-QE) Boot Camp for Quality Staff: It's
Not Just About Checking the Boxes
October 13, 2013 2:00 PM - 3:30 PM
Event Faculty List
Event Title: 9222-QE: Boot Camp for Quality Staff: It's Not Just About Checking the Boxes
Event Date: Sunday, October 13, 2013
Event Time: 2:00 PM to 3:30 PM
Director/Speaker Elaine Viggiano, MBA, MT(ASCP)SBB, CQA(ASQ) Executive Director, Quality, Compliance and Training Blood Bank of Delmarva [email protected] Disclosures: No
Moderator/Speaker Eva Quinley, MS, MT(ASCP)SBB, CQA(ASQ) [email protected] Disclosures: No
Speaker Tanya Hamilton, MS, MT(ASCP), CQA(ASQ) Quality Analyst NYU Langone Medical Center [email protected] Disclosures: No
Boot Camp for Quality Staff: It’s Just Not About Checking the Boxes
Training for New Quality Staff
Elaine Viggiano
Quality: A Review of Where Our Industry is Today
• Quality Assurance in Blood Establishments 1995 remains our “Gold Standard”
• This Guidance outlines FDA’s expectations for our industry
• Separate Unit reporting to the Executive Administration is mandated
• Defines the roles of Quality Control and Quality Assurance
WHY WE ARE ON THIS JOURNEY
• New faces in the Quality Department
• First impression was a lack of direction
• No clear Job Descriptions; staff was “bored”
• No in‐depth Quality/Regulatory experience was evident
• No management of daily activities
“GUIDELINE FOR QUALITY ASSURANCE IN BLOOD ESTABLISHMENTS; JULY 1995
EXPECTATIONS OF FDA
• Required a QA program consistent with the principles of Quality Assurance (Quality Systems) and cGMP (pg. 1)
• Include measures to “prevent ….assess, and correct errors…” (pg. 3)
• Has the responsibility to ensure that SOPs “accurately describe and define the procedure…” (pg. 6)
• Has the responsibility to ensure that “…SOPs comply with all applicable statutory and regulatory requirements.” (pg. 6)
• “Ensuring that SOPs for all QC/QA unit activities exist and define the QC/QA unit’s responsibility for performing…” these activities(pg. 7)
“GUIDELINE FOR QUALITY ASSURANCE INBLOOD ESTABLISHMENTS; JULY 1995, con’t.
• “Training should include the following programs: … QA Training…”
• Individuals conducting audits should possess sufficient knowledge, training, and experience…” (pg. 12)
Train/orient Quality Staff in these processes
Where Did We Begin ?
• Used Bloom’s Theory on the Taxonomy of Learning principles for our analysis:
– Outlined a classification of learning objectives for the transfer of knowledge and skills to adults
– Bloom believed that education should focus on subject mastery which would then promote higher forms of thinking
Bloom’s Theory: How Adults Learn
COGNITIVE AFFECTIVE PSYCHOMOTOR
KNOWLEDGE(INTELLECTUAL)
ATTITUDE (BEHAVIORAL)
SKILL(OPERABLE)
1 Recall data Receive (become aware) Imitate (copy)
2 Understand data Respond (react) Manipulate (follow instructions)
3 Apply information Value (act) Develop precision
4 Analyze information Organize (absorb) into personal values
Articulate (integration of related skills)
5 Synthesize information Internalize the value (adopt the behavior)
Naturalize (become “expert”)
6 Evaluate information:Critical Thinking
Bloom’s Theory: SUMMARY
CREATE
EVALUATE
ANALYZE
APPLY
UNDERSTAND
REMEMBER
EXPERT
EXAMINE CURRENT CASE
EXAMINE PAST CASE
“SEE‐ONE/DO ONE”
DISCUSSION/ASK QUESTIONS
READ/STUDY
BEYOND CHECKING THE BOXES:Critical Thinking
WE ASKED OURSELVES THESE QUESTIONS:
• What is Critical Thinking?
• What skills make a “critical thinker”?
• How is Critical Thinking taught ?
• How is successful Critical Thinking measured?
What is Critical Thinking ?
• The practice of applying intense, probing questions that aim to analyzeand evaluate.
• Proving what is commonly believed to be “true” is challenged with research and facts.
• The art of reflective skepticism that focuses on deciding what to believe.
• The process of unearthing, then researching, the assumptions that one operates under by taking a different perspective on familiar, taken‐for‐granted beliefs and behaviors.
DON’T TAKE ANYTHING FOR GRANTED!!
What skills make a Critical Thinker ?
• Separating emotions from facts (Suzy, our Technical Writer, has been here a long time; she must know everything)
• Eliminating stereotyping (we’ve always done it this way)
• Being passionate about research (let me check that FDA Regulation)
• Ability to determine what Regulatory consequences exist if Critical Thinking is not used (if my review is not thorough, what impact can it have on Compliance?)
• Ability to recognize logical fallacies, and to distinguish fact from opinion/interpretation (I’ll check the package insert and/or the Manufacturer’s Operator’s Manual for this step)
How is Critical Thinking taught?
• Developing a “value‐added” approach (the more I research, the more I can learn and apply this knowledge to my work)
• Creating a state of “disequilibrium” (I wonder if both scenarios can be true… challenge the learner’s beliefs by placing them in a conflicting mindset – research the topic)
• Offering constructive feedback to maximize the transfer of learning (let’s review your analysis of this SOP; we can discuss the tools and approach that you used)
• Actively participate in knowledge transfer (now that I’m confident that I have fully reviewed this SOP, I’ll discuss it with the Technical Writer)
How is successful Critical Thinking measured ?
• Outcomes based: oral/written quizzes, problem‐solving
• Discussion based: FDA CFRs, FDA Guidances, AABB Standards
• Successful demonstration of the knowledge/skill transfer: “see one/do one” approach
• Review of past events: oral review of the events, the analysis, and the summary
• Pre‐evaluation of real‐time events: discussion, presentation of facts, opinions, summary of recommendations
• Peer review of cases: routine open discussions, scheduled and unscheduled
Meeting the Intent of the FDA QA Guidance (1995)
• Using the Quality Systems approach, establish a generic, Departmental Training Profile :
– Audits
– Error Management/Process Improvement
– Document Control
– Validation
– Process Design/Change Control
– Regulatory Affairs
Impact of Prior Experience and Education
• Evaluate credentials, certifications, and progression in Quality
– Each QA staff member should have a Training Plan (what is hoped to be accomplished; what learning tools will be used)
– Supply rationale to the Training Profile; document thought process to individualize the Training Plan
– Review and assess Training Plan to the Job Description
– Primary responsibilities first, then cross‐training
Risks of Inadequate Job Performance
• Possibility/probability of an FDA 483 (or worse)
• Re‐seeding of inadequate/bad practices
• Sending the wrong message
Meeting the Intent of the FDAQA Guidance (1995), con’t
• Apply employee’s background, experience, and education/credentials to the Training Plan rationale (e.g., new employee trains on everything; seasoned employee may be able to bypass some of the basic reading materials) Rationale needs to be documented; evidence of experience, education/credentials in employee file)
• Those training activities that are bypassed should be evaluated via documented Competency Assessment
• Refer to Bloom’s chart for guidance in proceeding with training – use the tools that are needed
CONCLUSION:
• Bloom’s Theory may provide meaningful “stepping stones” to encourage the development of a QA staff Training Plan.
• By clear, intentional development of a Training Plan, the hierarchy of adult learning may be achieved.
• Bloom’s Theory may offer additional value in the assessment and development of skill sets necessary for success.
• By applying adult learning tools (such as Bloom’s Theory), the intent of the 1995 FDA Guidance may be met.
ELAINE VIGGIANOQUALITY, COMPLIANCE AND TRAINING
Blood Bank of Delmarva100 Hygeia Drive
Newark, DE 19713
Telephone: (302) 737-8405 X824Toll Free: (800) 548-4009
Fax: (302) 737-8233
www.delmarvablood.org
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Quality: It’s More Than Compliance
TrainingThe
Quality ProfessionalEva D. Quinley
Chief of Strategic Initiatives
MEDIC Blood Center
Knoxville, Tennessee
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The BIG Question
What Does Quality Need to Know?
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The Universe of Quality Training Needs
Quality Training
Quality SOPs and Tools
Operational SOPs
Soft Skills
Management
SafetyHR
Computer
ISO, Lean, Six Sigma
Regulations and
Standards
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Quality Training
• Quality Principles– Quality SOPs– Regulations– Standards – Conducting reviews
• SOPs– Validation protocols– Training
• Safety• Business and HR
– SOPs– Budgeting– Staffing– Filling out HR forms
• Computer Skills• Soft Skills
– Conflict resolution– Time management– Negotiating skills
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Quality Specific Training - Quality SOPs
• Quality Manual
• SOP on SOPs
• Good Documentation Practices
• Deviation Management, including reporting requirements
• Validation
• Supplier Qualification
• Auditing
• Change Management
• Inspection related SOPs
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Quality Specific Training –Regulations/Standards
• 21 CFR 600
• 21 CFR 200
• 21 CFR 1271
• 21 CFR 820
• FDA Guidance Documents
• State Regulations
• Familiarity with FDA website
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Quality Specific Training - Standards
• AABB
• FACT
• TJC
• Other
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Quality Specific Training - Conducting Reviews
• Review methodology
• What a review signature means
• Review responsibilities
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Safety
• OSHA Regulations
• Blood Borne Pathogen training
• State Regulations
• Waste Disposal
• Reporting Requirements
• Emergency Preparedness Plan
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Business and HR Related Training
• Operational SOPs– Observe operations in action
• Confidentiality
• Budgeting
• Scheduling
• Filling out HR forms such as PTO, Flexible Spending
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Computer Training
• Microsoft Office
• PowerPoint
• BECs
• Computerized Quality Systems
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Soft Skills Training
• Time Management
• Listening
• Dealing with Difficult People
• Negotiating
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Training Methodologies
• Read and Understand
• Observation
• Case Studies
• Videos
• Role Play
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Competency Assessment
• Initial - detailed– Checklist
– Written test
– Observation
• Ongoing– Observation of task in action
– Record review
– Review of deviations
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ISO, Lean, Six Sigma
• Remove opportunities for defects
• Gain control
• Increase efficiencies
• Improve overall quality
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Quality Credentials
• ASQ
• Degrees
• Six Sigma
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?
Training Blood Bank Quality Staff
Objectives
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Components of a Training Program
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Management Review
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Management Review
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Needs Assessment
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Program Content
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Sample Training Program
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Regulations
AABB Standards for Cellular Therapy Services
CAP: Transfusion Medicine Checklist, Laboratory General Checklist
CLIA
FACT-JACIE Cellular Therapy Accreditation Manual
FACT-JACIE International Standards for Cellular Therapy Product Collection, Processing and Administration
Joint Commission
State Department of Health
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Module 1: Introduction to Quality Management
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Module 1: Introduction to Quality Management
o State the purpose of a quality manual
o Discuss ways to organize the contents of a quality manual
o Describe a quality plan
o Review the Transfusion Service Quality Plan
o Maintain the required QA documentation
o Pre-assessment quiz
o Post-assessment quiz
o References
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STAGE DEFINITION
Total Quality Management (TQM)Management approach centered on sustained high quality, by focusing on long-term success through customer satisfaction.
Quality Management (QM)Systemic process-oriented approach to quality objectives. Includes levels below and the economic cost of quality.
Quality System (QS)
Comprehensive and coordinated efforts to meet quality objectives.
The organizational structure, procedures, processes and resources needed to implement quality management.
Quality Assurance (QA)
Planned and systemic activities to provide confidence that an organization fulfills requirement for quality.
Actions planned and taken to provide confidence that all systems and elements that influence the quality of the product or service are working as expected individually and collectively.
Quality Control (QC)
Operational and process control techniques to fulfill requirements for quality and governmental compliance.
Activities and controls used to determine the accuracy and reliability of the facility’s personnel, equipment, reagents and operations.
Source: A Quality Management System for Healthcare; CLSI Guideline HS1-A2Quality Systems in the Blood Bank Environment, AABB Press
Quality System Model
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Source: Modern Blood Banking & Transfusion Practices, D. Harmening
Path of workflow (work operations)Pre-Service Service Post-Service
Intro to Quality Management Quiz
a) Quality Assuranceb) Quality controlc) Care indicatorsd) Care outcomes
a) Quality Assuranceb) Quality assessment and improvementc) Total Quality Managementd) Quality Control
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Program Delivery
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Program Evaluation
o Did the program meet the established training goal?
o If not, what changes need to be made to achieve the goal?
o Did the training meet its objectives?
o Do you see a difference in behavior because of the training?
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Documentation of Training
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Training Ideas for Experienced Staff
• Certified Quality Auditor (CQA)
• Certified Manager of Quality/Organizational Excellence (CQM/OE)
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Training Ideas for Experienced Staff
o AABB Technical Manualo Quality Systems in the Blood Bank, 2nd edition, AABB (out of print)o Clinical and Laboratory Standards Institute (CLSI) document: HS1-A2: A
Quality Management System Model for Healthcare; Approved GuidelineHS1, 2nd edition
o Failure Mode and Effects Analysis in Health Care: Proactive RiskReduction, Third Edition, Joint Commission. ISBN: 978-1-59940-406-6
AABB: www.aabb.orgAmerican Society for Quality: www.asq.orgCollege of American Pathologists: www.cap.orgClinical and Laboratory Standards Institute: www.clsi.orgCOLA: www.cola.orgFDA: www.fda.gov/BiologicsBloodVaccines/BloodBloodProducts/default.htmThe Joint Commission: www.jointcommission.org
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Reference
o AABB Technical Manualo Quality Systems in the Blood Bank, 2nd edition, AABB (out of print)o Clinical and Laboratory Standards Institute (CLSI) document: HS1-A2: A Quality Management System Model for Healthcare; Approved Guideline HS1, 2nd edition
o Failure Mode and Effects Analysis in Health Care: Proactive Risk Reduction, Third Edition, Joint Commission. ISBN: 978-1-59940-406-6
AABB: www.aabb.orgAmerican Society for Quality: www.asq.orgCollege of American Pathologists: www.cap.orgClinical and Laboratory Standards Institute: www.clsi.orgCOLA: www.cola.orgFDA: www.fda.gov/BiologicsBloodVaccines/BloodBloodProducts/default.htmThe Joint Commission: www.jointcommission.org
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