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Establishing and Implementing a Quality Management Plan
September 23, 2009
FACT Webinar Presenters
Robert Rifkin, MD, FACPRocky Mountain Cancer Center
Denver, CO USA
Tracy Dodd, BA, MBA, RN, CPHQ
Medical College of WisconsinMilwaukee, WI USA
In accordance with the standards of the Accreditation Council for Continuing Medical Education (ACCME), all speakers are asked to disclose any real or apparent conflicts of interest, which may have a direct bearing on the subject matter they will be presenting.
These speakers have indicated no conflict of interest to disclose.
This information was disclosed in written form in compliance with the ACCME Standards for Commercial Support of Continuing Medical Education.
Establishing and Implementing a Quality Management PlanRobert Rifkin, MD, FACP and Tracy Dodd, BA, MBA, RN, CPHQ
Purpose
Explain the overall QM Plan– What to include in the plan and/or references– Future sessions will give details about how to
actually do these things Provide tips on how to:
– Establish a QM Plan– Implement the QM Plan– Maintain and continuously improve the QM Plan
Origin of QM in Cellular Therapy and Cord Blood Standards
Related healthcare industries United States FDA regulations Increased clinical application of HPC and TC Evolution of complex program and bank
structures
QM requirements in Cellular Therapy and Cord Blood Standards were written by your peers and colleagues
Definition of a QM Plan
A written document that describes the systems in place to implement the quality management
program.
Written documentation of how programs and banks fulfill QM requirements
Description of the QM systems Implementation plan Direction for carrying out the overall QM program
Blood and Marrow Interactions
FH
Clinicalprogram
CHW
Clinicalprogram
BCW
MCW CPL
Marrow collect
Marrow collect
Registry or Banked Products
QI Program
Apheresis Services
Registry or Banked Products
Establishing a QM Plan
Organization of QM Plan Standards
Cellular Therapy– Listed in each section (B4, C4, and D4)– Subsequent standards in section must be
addressed– Repeated for flexibility
Cord Blood– 3rd edition: Stand alone (Section A)– 4th edition: Within CBB Operations section
Quality management vs quality control
Three Main Parts to a QM Plan
Structural Requirements Assessment and Reporting Information and Document Control
The QM Plan in Perspective
QM Plan
Organizational Chart
Personnel Requirements
Critical Processes,
Policies, and Procedures
Document Control
Written AgreementsOutcome
Analysis
Audits
Positive Microbial Cultures
IncidentsProduct/Unit Tracking and
Tracing
Continuous Operations
Validation
Qualification
External ThreatsInternal Weaknesses
Suggested Steps to Establishing a QM Plan
Assess existing materials Address missing elements Conduct final assessment with FACT
Inspection Checklist Obtain final approval of the QM Plan
Common Questions
“Where do we begin?”– Identify what you already have– Follow the order of the Standards
How do we integrate with:– “Main institution’s QM Plan?”– “Distinct facilities?”
Common Questions
“How detailed does the QM Plan need to be?”– Include all the details– Summarize in the
plan and reference an SOP
– Use the same format in the SOP for SOPs
Cellular Therapy Product InstitutionQuality Management Plan
Page 2Structure:An organizational chart of key personnel in the Collection
Facility can be found in Procedure 1-2007. The Collection Facility Director is responsible for ensuring the Quality Management Program is effectively established and maintained. The Quality Management Supervisor is delegated responsibility for operational aspects of maintaining the Quality Management Program. This designated individual will report on quality management activities at monthly staff meetings and will provide a detailed quarterly report to the Collection Facility Director. All personnel in the Collection Facility are responsible for participating in the Quality Management Program through identification of improvement needs and establishment and review of policies and procedures. See Procedure 2-2007 for details of this process.
Quality AuditsIndependent quality audits will be conducted on a quarterly
basis to verify compliance with the Quality Management Program, recognize problems, detect trends, and identify improvement opportunities. Policies and procedures will be selected for audits based upon sentinel events, importance to quality of care, and/or previous audits. See Procedure 3-2007 for a detailed audit policy and procedure.
Common Questions
“How do we create systems that are substantive but attainable?”– Meet the intent of Standards, regulations, etc.– Prioritize based upon impact to patient– Focus on what truly impacts quality rather than
what sounds good
Implementing a QM Plan
Case Studies
Each required element in a QM Plan will be separately explained
A group of these elements will then be illustrated within a common idea in cellular therapy
Goal: Demonstrate how pieces of the QM Plan ties together to manage quality
Organizational Chart and Description of Interactions
Integration, cohesiveness, and objectivity throughout the entire life cycle of a cellular therapy product or cord blood unit
Break down barriers– Physical space– Functions– Timing and chain of custody– Leadership– Third parties– Conflicts of interest
Written Agreements Third parties whose services impact the cellular
therapy product or cord blood unit understand and comply with requirements– Reference Standards in agreements– Does not include suppliers (use vendor qualification)– Only applies to agreements that impact products or
units– Include general description of process if no written
agreements are currently used – commonly cited!
Tracking and Tracing
Enable investigation of issues, document chain of custody, and maintain information needed for further action– Tracking: to follow a process from beginning to
end– Tracing: to follow the history of a process, product,
or service by review of documents
Case Study: CBB Structure
Non-fixed Sites
Collecting Health
ProfessionalDonor
Courier Service
RegistryClinical
Program
Testing Laboratories
Chart: reporting relationship Dotted lines: External parties Numbers: Tracking and tracing
1a2a
3
4 5
6
7
8
910 11
12
1b
2b
Personnel
Documentation of personnel qualifications and ownership of processes
Investments in personnel that increase quality:– Education– Self-improvement– Empowerment– Job satisfaction
Critical Processes, Policies, and Procedures
Each critical process, policy, and procedure remains accurate, operational, and relevant– Development– Approval– Validation– Implementation– Review– Revision– Archival
Document Control
Critical documents used in the manufacturing process are current and protected
Similar to process control, but specific to documents– SOPs– Worksheets– Forms– Labels
Make sure the specific types of documents are listed in the QM Plan!
Case Study: Clinical Program Infection Control
Personnel Processes Documents
Capable and empowered to
generate new ideas to improve current
processes related to infection control
Thoroughly developed, reviewed, and
documented to be effective at preventing
infection
Protected and controlled to always instruct personnel to
follow current infection control procedures – not outdated ones!
Outcome Analysis Therapeutic outcomes can indicate the quality
of a cellular therapy program or cord blood bank’s processes.
Use the data to analyze the entire program or bank:– Analyze the data on an ongoing basis– Share the analysis with all aspects of the program or bank– Required and suggested criteria for product efficacy/clinical
outcome in applicable Standards and Accreditation Manuals– Cord Blood Banks must make genuine effort to obtain the
data from clinical programs
Handout Example: Acute GVHD Assessment
Audits
Verification that policies and procedures are implemented and complied with
Particularly important for clinical programs due to difficulty validating clinical processes
A timetable, or schedule, is required Prioritize audits based upon risk of adverse
event, assessment data, surveys, complaints
Handout Example: Clinical Performance Audit
Qualification
Equipment, supplies, and reagents function consistently as they are supposed to function– Establish minimum requirements for accepting
supplies and reagents– Establish minimum requirements for using
equipment– Confirm and document the requirements are met
before use
Does not apply to Cellular Therapy Clinical Programs.
Validation and/or Verification
Confirm through objective evidence that cellular therapy products and cord blood units consistently meet specifications– First determine objective data to collect– Include all variables to ensure consistency– Compare data to specifications to ensure they are
met
Does not apply to Cellular Therapy Clinical Programs.
Performance vs Outcome Metrics Performance metrics: measure how personnel
comply with policies and procedures, for example:– Completion of all donor evaluation steps– Inclusion of all requirements on chemotherapy order– Regular standardization and calibration of processing equipment
Outcome metrics: measure success of therapy, for example:– Days to engraftment– Length of hospital stay– Survival
Case Study: Investigation of Poor Engraftment Results
Clinical Program reports outcome analysis results:
poor engraftment likely due to low cell counts
Audit identified noncompliance with collection procedure
Handout Example: Delayed Engraftment SOP
Positive Microbial Culture Results A major role of a Quality Management Plan is to
assess regulatory affairs and ensure requirements are met
One of the concerns of the US FDA is the use of products with positive microbial cultures– Must ensure there is urgent medical need, that the recipient and
all facilities know about the positive culture, an investigation is completed, and the incident is reported to the regulatory authority
– Requires extensive teamwork between collection sites, processing facilities, cord blood banks (if applicable), and clinical programs
Errors, Accidents, Suspected Adverse Events, Biological Product Deviations,
Variances, and Complaints Ability to detect issues, correct both isolated
and systematic problems, and report to the appropriate organizations– Detect– Investigate– Document– Track– Report– Correct– Evaluate
Case Study: Storage Conditions
Low Liquid
Nitrogen
Continuous Operations
Be able to meet requirements when computer systems fail– Critical clinical documents– Donor evaluation and consent forms– Processing worksheets
Maintaining a QM Plan
Maintaining a QM Plan
Annual review in conjunction with annual reporting to Directors
Review applicable sections when SOPs are revised
Identify opportunities for improvement Remain current with laws and regulations and
Standards
Common Citations Regarding QM Plans
Overall QM program (CT B4.1.1)– Not documented in plan (but may be operational)– Separate QM programs without integration– Lack of overall QM program
Organizational Chart (CT B/C/D4.2; CB A3.1, A3.2)– Vague or incomplete– Misrepresents actual functions and interactions– Lack of organizational chart– Lack of interaction from various program/bank
components
Common Citations RegardingQM Plans
Description of interactions (CT B/C/D4.2.1)– Often missing
Director responsibility (CT B/C/D4.2.2; CB A2.2)– No allowance for delegation– No clear designation for responsibility for QM
activities– Little evidence of involvement
Commonly Missing Elements
Trainer qualifications System to prevent accidental or unauthorized
changes Reporting of outcome analysis (e.g., engraftment) to
entire program Schedule of planned audits Positive microbial cultures Complaints Planned and unplanned deviations
Thank you for joining us today. This was the first session of the QM Series’
Module 1: Administrative Aspects of QM. Join us for the upcoming sessions in this module:
– Virtual Roundtable: Time, Effort, and Resources for FACT Accreditation; October 2, 2009 at 1 pm ET
– Tutorial: The SOP for SOPs; November 2009
• Join us for the next QM Series module:– Quality Management Monitoring and Assessment
Activities: Winter 2010
Evaluations and Continuing Education Credit
All inspectors can obtain CME/CNE certificates free of charge via the online Inspector Area
Program and bank personnel requesting CME/CNE credit can purchase credit for $20 via the FACT webinar web page
Evaluations will be distributed to participants not wishing to receive CME/CNE credit
Question and Answer Session
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