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Establishing and Implementing a Quality Management Plan September 23, 2009.

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Presentation on theme: "Establishing and Implementing a Quality Management Plan September 23, 2009."— Presentation transcript:

1 Establishing and Implementing a Quality Management Plan September 23, 2009

2 FACT Webinar Presenters Robert Rifkin, MD, FACP Rocky Mountain Cancer Center Denver, CO USA Tracy Dodd, BA, MBA, RN, CPHQ Medical College of Wisconsin Milwaukee, 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.

3 Establishing and Implementing a Quality Management Plan Robert Rifkin, MD, FACP and Tracy Dodd, BA, MBA, RN, CPHQ

4 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

5 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

6 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

7 Blood and Marrow Interactions FH Clinical program CHW Clinical program BCW MCW CPL Marrow collect Marrow collect Registry or Banked Products QI Program Apheresis Services Registry or Banked Products

8 Establishing a QM Plan

9 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 –3 rd edition: Stand alone (Section A) –4 th edition: Within CBB Operations section  Quality management vs quality control

10 Three Main Parts to a QM Plan  Structural Requirements  Assessment and Reporting  Information and Document Control

11 The QM Plan in Perspective QM Plan Organizational Chart Personnel Requirements Critical Processes, Policies, and Procedures Document Control Written Agreements Outcome Analysis Audits Positive Microbial Cultures Incidents Product/Unit Tracking and Tracing Continuous Operations Validation Qualification External Threats Internal Weaknesses

12 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

13 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?”

14 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 Institution Quality Management Plan Page 2 Structure: An organizational chart of key personnel in the Collection Facility can be found in Procedure 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 for details of this process. Quality Audits Independent 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 for a detailed audit policy and procedure.

15 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

16 Implementing a QM Plan

17 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

18 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

19 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!

20 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

21 Case Study: CBB Structure CBB Director CBB Medical Director Fixed Collection Site Director Donor Processing Facility Director Processing Supervisor Processing Personnel QM Non-fixed Sites Collecting Health Professional Donor Courier Service Registry Clinical Program Testing Laboratories  Chart: reporting relationship  Dotted lines: External parties  Numbers: Tracking and tracing 1a 2a b 2b

22 Personnel  Documentation of personnel qualifications and ownership of processes  Investments in personnel that increase quality: – Education – Self-improvement – Empowerment – Job satisfaction

23 Critical Processes, Policies, and Procedures  Each critical process, policy, and procedure remains accurate, operational, and relevant – Development – Approval – Validation – Implementation – Review – Revision – Archival

24 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!

25 Case Study: Clinical Program Infection Control PersonnelProcessesDocuments 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!

26 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

27 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

28 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.

29 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.

30 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

31 Case Study: Investigation of Poor Engraftment Results Collection procedure validated to achieve target cell counts at time of implementation Validation Study Apheresis machine undergoes Operational Qualification (OQ) to ensure it is still functioning appropriately Qualification Personnel compliance with collection procedure audited to ensure all necessary steps are followed Audit 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

32 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

33 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

34 Case Study: Storage Conditions DetectionEvaluationInvestigationDocumentationReporting Short-term Corrective Action Long-term Corrective Action Follow-up Activities Low Liquid Nitrogen

35 Continuous Operations  Be able to meet requirements when computer systems fail – Critical clinical documents – Donor evaluation and consent forms – Processing worksheets

36 Maintaining a QM Plan

37  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

38 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

39 Common Citations Regarding QM 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

40 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

41 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

42 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

43 Question and Answer Session


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