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Establishing and Implementing a Quality Management Plan

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1 Establishing and Implementing a Quality Management Plan
September 23, 2009 Presenter – Kara [In the minutes before the webinar, announce to the audience that the presentation will start in 10 then 5 minutes.] Welcome to today’s FACT webinar. The topic of this webinar is establishing and implementing a Quality Management Plan. This webinar will begin with an approximately 45 minute presentation. Following the presentation, a question and answer session will take place for the remainder of the webinar. All participant telephone lines will be placed on mute during the presentation. This webinar is being recorded for individuals to access if they were not able to attend today. If you have questions during the presentation, please type the question in the box that can be found under the Q & A menu at the top of your screen. These questions will be addressed during the Q & A session.

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. Presenter – Kara Today’s presenters are Dr. Robert Rifkin and Tracy Dodd. These speakers have no conflict of interest to the webinar’s subject matter.

3 Establishing and Implementing a Quality Management Plan
Presenters begin The purpose of this webinar is to discuss how to establish and implement a Quality Management Plan. Quality Management Plans can be in a variety of formats, of various lengths, and with different levels of details. This is more than “just okay,” this is expected. Quality Management Plans should be individualized to match your own program or bank. While it is helpful to look at how others create their plans, it is still important to go through the entire process of establishing and implementing your plan to ensure that the content and direction of it fits your needs. Robert Rifkin, MD, FACP and Tracy Dodd, BA, MBA, RN, CPHQ

4 Purpose Explain the overall QM Plan Provide tips on how to:
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 The purpose of this webinar is to explain the overall QM Plan and how it fits in the QM Program of a cellular therapy program or cord blood bank. The content will be focused on information specific to the plan itself, but will not give specific details about each of the required elements within the plan. This session is intended to focus solely on what is required in the QM Plan and/or in the references within that plan. Future sessions will be dedicated to the details on how to actually do those things. This enables in-depth material of issues surrounding the general management of the QM Plan. In this presentation, we will provide tips on how to establish a QM Plan, implement the plan, and then maintain and continuously improve the QM Plan. Most cellular therapy programs and some cord blood banks already have a QM Plan established, and there will be tips throughout the presentation that will help you take what you currently have and make it even better.

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 The field of quality management has been around for a long time; however, it is still relatively new and mysterious to cellular therapy programs and cord blood banks. QM requirements were included in the first two editions of the Standards; however, the real turning point for emphasis on QM activities in the FACT accreditation process was with the release of the third edition Cellular Therapy Standards and Cord Blood Standards. The Quality Management sections were greatly expanded – and there are several reasons for this. First of all, Quality Management became a large part of related health care industries, especially the pharmaceutical industry. As cellular therapy products and cord blood units became perceived as a biological drug, the emphasis on quality management began to be applied to the cellular therapy industry. Second, the United States FDA regulations, 21 CFR Part 1271 became effective on May 25, Subpart D of this regulation set forth current good tissue practice, which requires programs and banks to “recover, process, store, label, package, and distribute HCT/Ps, and screen and test cell and tissue donors, in a way that prevents the introduction, transmission, or spread of communicable diseases.” Within this subpart, establishments that perform any step in the manufacture of HCT/Ps must establish and maintain a quality program. The quality program is required to address all core current good tissue practices listed in Since one of the stated benefits of FACT accreditation is that it is a compliance tool, FACT’s first approach to this regulation, which was the third edition, was to include all of the core current good tissue practices in the Quality Management section. In response to feedback that this organizational approach resulted in confusion and redundancy, the requirements were dispersed into the operational sections to which they pertain and an SOP requirement for each was listed in the Policies and Procedures sections. Third, the increased clinical application of HPC and TC requires programs and banks to be even more diligent to ensure the products and units are of high quality because they are actually being administered to patients. Finally, the evolution of complex program and bank structures, such as outpatient clinics or several cord blood collection sites, necessitates standardized procedures, communication, and collection and evaluation of data.

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 The definition of a QM Plan is “a written document that describes the systems in place to implement the quality management program.” QM Plans serve as written documentation of how programs and banks fulfill QM requirements. For inspection purposes, the QM Plan provides a foundation for inspectors to understand how the QM program functions. More importantly, for operational purposes, QM Plans enable programs and banks to put their ideas on paper and thoroughly plan out how the QM program will function in an efficient, effective manner to ensure high quality cellular therapy products and patient care. To adequately address all requirements of a QM Program, all of those requirements must be in the plan. QM Plans basically include descriptions of the QM systems in place. This is a common source of confusion for programs and banks. The Standards contain a large amount of requirements for inclusion in the QM Plans, so it is easy to become overwhelmed and believe that the QM Plan is intended to be a voluminous and intimidating document. This is not the intent! QM Plans can actually be as brief as you wish. More information regarding what must be included will be provided later in this presentation. The key is to ensure that there is at least a description of all of the required elements so that your program or bank has a framework for implementing the QM program. That is what a QM Plan is – an implementation plan. The QM Plan may be difficult to establish, but once it is finished, it should be a helpful tool for your program and bank to assist with implementing the QM program. For example, when you are ready to begin your audits or validation studies, the QM Plan should be a good reference tool to help you know what to assess, when to do the assessment, and how. Finally, the QM Plan provides direction for carrying out the overall QM program. As many of you are probably aware of at this point, a QM program is not a linear process, but a circular one. A qualification or validation may show results that require continuous improvement. An adverse reaction necessitates the need for reporting. By documenting what to do in these situations, your program and bank can be confident that all necessary steps are completed.

7 Blood and Marrow Interactions
Registry or Banked Products MCW CPL Registry or Banked Products CHW FH Clinical program Marrow collect Marrow collect Clinical program QI Program This diagram illustrates how all functions of the Medical College of Wisconsin’s program center around the Quality Management Program. [Explain diagram] BCW Apheresis Services

8 Establishing a QM Plan This portion of the webinar will go over tips on how to establish a QM Plan. The FACT Standards contain minimum guidelines, and these tips will focus on those minimum requirements; however, remember that the QM Plan should be helpful to your program, and more information can be included beyond what is required by FACT. Many of you probably already have a QM Plan. These tips will still be useful to you and can be used as part of the annual review of your 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 3rd edition: Stand alone (Section A) 4th edition: Within CBB Operations section Quality management vs quality control Understanding how the QM Plan Standards are organized is helpful for compliance. It is a good idea to follow the general sequence of the Standards because they are organized in a logical flow to help programs and banks create their plans; however this is not required. It is also discouraged to repeat verbatim what the Standards say just to be able to check “Yes” to the questions on the checklist. This makes inspectors wonder if the Standards were simply copied rather than given thoughtful consideration for how they can be implemented to effect results at your program or bank. The Quality Management Plan Standards historically were brief sections near the beginning of the entire Cellular Therapy Standards document. However, in the third and fourth editions, QM requirements were listed in each major section within a subsection devoted to Quality Management. The specific requirement to establish and maintain a written QM Plan was the first requirement listed, which sets the tone for the rest of the subsection. This is intentional organization – the QM Plan should be the starting point for a QM program, and all subsequent standards in the section must be addressed within the plan. The QM Standards are repeated for flexibility in program structures, except in cases where a requirement is specific to a function, such as a clinical program. When requirements are repeated, it does not mean that the same thing needs to be done three times! One QM Plan can satisfy the requirements in all three sections. In fact, setting up a QM Plan this way, while optional, is a good mechanism to ensure an integrated program. In Cord Blood Standards, QM was addressed in a stand alone section, Section A. However, in the draft fourth edition, scheduled for publication in January 2010, the QM section will be included in the main Cord Blood Bank Operational Standards section. This is to logically include the requirements in the section that is intended to be applied to ALL phases of cord blood banking, from donor recruitment to collection to processing to release for administration. An important distinction to make in the Standards is the idea of Quality management versus quality control. The overarching purpose of FACT is to promote high quality cellular therapy, and all of the requirements should be construed as quality issues. However, the QM requirements are focused on the managing of your program’s or bank’s processes to control its quality. In the third edition of both standards, the quality management section contained several quality control requirements although they were more of operational issues. In the fourth editions, the quality control requirements were moved to the operational sections to which they pertain so that it was more clear of a distinction between managing quality programs and controlling quality results.

10 Three Main Parts to a QM Plan
Structural Requirements Assessment and Reporting Information and Document Control This slide also contains information from the FACT Quality Management tutorial. It has a lot of information and is worth repeating because it provides an outline of the three main parts to a QM Plan. It is helpful to remember that the requirements listed in the Standards truly serve three main purposes: Structural Requirements, Assessment and Reporting, and Information and Document Control. These elements encompass the actual function of the QM program. Structural Requirements: Dictate who is responsible for the QM program, how the QM program is organized, personnel requirements, and the process for developing and implementing processes, policies, and procedures Assessment and Reporting: Activities that allow measurement of results of the QM program and mechanisms for reporting those results, such as outcome analysis, audits, validations, qualifications, biological product deviations, etc. Information and Document Control: Protection of documents, product and unit tracking, continuous operations when IT fails.

11 The QM Plan in Perspective
External Threats Internal Weaknesses QM Plan Critical Processes, Policies, and Procedures Personnel Requirements Document Control Organizational Chart At the time you embark on either creating a new QM Plan or revising an existing one, it is important to put it in perspective. What is the point of the QM Plan – what role does it play, and how important of a piece is it within the overall program? Each program or bank will face external threats outside of its control, which include comorbidities of patients, regulatory and political pressure, faulty manufacturing of supplies, and other types of issues programs and banks deal with. Programs and banks also have inherent internal weaknesses – we all have things that we can work on and improve. This can include communication issues, facility limitations, staff turnover, and other similar issues. The QM Plan is an umbrella document to protect programs and banks from those external threats and internal weaknesses. Since we can expect that we will come across issues that could negatively impact our services and products, we need to plan how we will not only detect and correct them but how we will minimize and prevent them. There are several tools to do this, which are all listed in the Standards. But these tools are not effective if used completely independently in a disconnected manner. The QM Plan serves as the umbrella, which is intended to direct the program or bank how to use these tools to your advantage. The specific details do not need to be in this umbrella document, but must be referenced so that it is clear to readers how all the tools will work together to bring about quality results. Audits Written Agreements Outcome Analysis Positive Microbial Cultures Incidents Product/Unit Tracking and Tracing Continuous Operations Qualification Validation

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 These are suggested steps for establishing a QM Plan. These are just suggestions, and many other approaches would work just as well or better. First, assess existing materials such as SOPs, policies, contracts, etc. for compliance with the Standards. To do this, use the Standards as a template or checklist. Second, address the missing elements. If you are starting from scratch, this basically means to begin drafting everything. Divide and conquer the items that must be drafted – the QM Supervisor doesn’t have to and shouldn’t be the only individual involved in this process. For example, work with your human resources department to address the personnel requirements, IT staff to address electronic data back up requirements, Directors to address written agreement requirements, processing technicians to address validation requirements, and so on. The more involved personnel are, the more engaged and supportive they will be when it comes time to implement the QM Plan. Sometimes, it is easier to start with the SOPs first and then describe them in the QM Plan. Use complaints as an example. It may be easier to review the Standards and regulations and then work out the steps for how to address complaints before trying to write a brief overview for the QM Plan. This is perfectly fine, and serves as two important parts of the QM Program – you would be addressing two FACT requirements at once! After all of the missing elements have been addressed, conduct yet another assessment of the new draft with the actual inspection checklist (available on the FACT website) to be sure nothing was forgotten. Once that assessment concludes that everything is present, go through the approval process (outlined in the QM Plan!) to obtain final approval of the QM Plan.

13 Common Questions “Where do we begin?” How do we integrate with:
Identify what you already have Follow the order of the Standards How do we integrate with: “Main institution’s QM Plan?” “Distinct facilities?” There are several common questions regarding how to set up the QM Plan. We will go over some of these and provide suggestions. A common question is, “Where do we begin?” For programs and banks who already have an existing QM program but wish to make it better, you should first identify what you already have – you may have several workable pieces of a QM Plan but just need to expand upon them or fill in some holes. Whether or not you already have an existing QM program or are starting from scratch, you should then follow the order of the Standards and confirm the presence of all of the requirements. This helps ensure that all requirements are met and gives you a starting point for where you need to improve. Another question is, “How do we integrate our QM Plan with our main institution’s QM Plan?” This is a great question, because utilizing institutional QM Plans is a great way to achieve synergies and prevent duplication of work. However, it is a bit tricky because there are specific needs for cellular therapy programs and cord blood banks that most likely will not be addressed in an institutional plan. There are three ways an applicant’s QM program may be related to the institution’s program: 1) nested within the Institutional QM program, 2) shared components with the Institutional QM program, or 3) completely separate from the Institutional QM program. No matter how the applicant-specific program fits into the institution’s, each relationship has some applicant-specific material. For example, a Collection Facility may use its institution’s disaster plan, but it must have SOPs specific to how the Collection Facility would handle a disaster. There may be an SOP for what to do when a tornado strikes the area while a patient is in the middle of an apheresis procedure. Facilities must also actively participate in the program no matter how integrated its program is with the institution’s; the applicant must review SOPs annually and participate and conduct assessment activities. People also ask, “How do we integrate with the distinct facilities in our overall transplant program or cord blood bank?” Again, this is a good question. If you are a clinical program that contracts out collection or processing facilities, or if you are a stand-alone collection or processing facility, you can either have a QM Plan that is completely integrated or you can have separate QM Plans that have provisions for communication. However, remember that the Clinical Program must have an overall QM Plan and that even contracted facilities must meet all Standards requirements.

14 Quality Management Plan
Common Questions 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. “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 Another common question is, “How detailed does the QM Plan need to be?” In the previous editions of the Standards, several requirements were included in an effort to be as inclusive as possible. However, this was perceived to say that the QM Plan needs to be a very large document. The Standards Committee has made an effort to clarify the level of detail required of the QM Plan. In simplest terms, the QM Plan needs to be detailed enough to give a general explanation of how the requirements will be met, with direction on how to find the details. One option is to include all of the details, including step-wise procedures, within the QM Plan. This can be for all elements required in the Standards, or it can be for just a select few, such as including the organizational chart in the plan itself. A drawback to including all of the details is that it makes the annual review very cumbersome, and results in many iterations of the QM Plan due to revisions of several distinct issues in the plan. You can also summarize the system in the plan and then reference SOPs that provide the details. This slide shows an example provided in the FACT Quality Management tutorial. As you can see, the QM Plan briefly describes how they meet a requirement and then references the actual SOP for the details. This approach is probably the easiest to maintain, as it allows for a more concise document but serves as a reference tool for finding the related SOPs. Remember – the QM Plan does not need all the details but must point the reader to where the details can be found. However, there does need to be some text in full sentences – one program submitted a QM Plan that was simply an outline of the SOPs; this is not sufficient because it does not explain how the SOPs are used to ensure quality. It may be helpful to write your plan in the same format as designated in your SOP for SOPs. This gives a solid outline for how to reference detailed procedures, designate who is responsible for the QM Plan, etc.

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 One of the greatest paradoxes with the Quality Management Plan is that it has to include goals to make the program or bank better, but you have to be able to live up to the plan. People often ask, “How do we create systems that are substantive but attainable?” This question often comes from people who have created a plan to meet explicit requirements, but still haven’t materialized the main intent of having a plan that enables continuous improvement. An easy first step is to be sure the intent of applicable standards and regulations are met. While this will help you pass inspections, the reason this is really helpful is because standards and regulations have already identified what is most crucial to include in minimum guidelines. After you are aware that the intent is met, then you should prioritize goals based upon impact to the patient – whether a donor or recipient. Audits of the donor evaluation process, validation studies of collection and processing cell counts, and outcome analyses are critical activities to ensure high quality cellular therapy and cord blood banking, as is the communication of results of these activities to all involved facilities. Finally, focus on what truly impacts quality rather than what sounds good. It may sound good to do a validation study every month, but that may not be practical or necessary. Well-designed activities that occur quarterly or semi-annually or annually are better than superficial activities that occur monthly.

16 Implementing a QM Plan This next section of the presentation will discuss implementing a QM Plan. The focus is on the intent of the FACT Standards – by understanding why the requirements are what they are, you will better recognize the value of these processes and will have an easier time implementing them. As discussed in the previous webinar, the FACT Standards have already whittled down the most important QM needs in cellular therapy programs and cord blood banks. In the fourth editions, they were even organized in an order most logical for implementation. We will explain how to go beyond simply checking off these items, but using them to embrace quality in your program or bank. Future sessions will discuss the specific details of how to implement each of these requirements.

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 One of the first requirements of a Quality Management Plan is the inclusion of an organizational chart. The purpose of the organizational chart is to ensure integration and objectivity throughout the entire life cycle of a cellular therapy product or cord blood unit. Remember that the description of interactions is often missing, but it is important because it gives the details on how to implement the structure of your QM Plan. For each relationship outlined in the organizational chart, be sure to think about the actual interactions within the program or bank and identify ways to break down barriers that prevent a cohesive, integrated process. Physical space: Facilities are often on different floors, different buildings, and, especially in the case of cord blood collection sites, different cities. The organizational chart should illustrate how people at different physical locations interact. Functions: There are distinct functions during the manufacture of a cellular therapy product or cord blood unit, such as collection, processing, storage, and administration, and it is too easy for personnel in these different functions to operate in silos. Find a way to ensure regular interaction between all functions. Timing and chain of custody: Once a product or unit leaves the control of a facility, it doesn’t mean that the facility no longer has responsibility for it. The organizational chart should illustrate that there is a mechanism for reporting deviations, adverse events, etc. and working together to investigate those issue. Leadership: The leaders of the program or bank are required to be involved in the daily operations, and the organization of your program or bank should allow this. Third parties: Many services are contracted to third parties, such as testing laboratories and collection or processing facilities. Including these parties on your organizational chart and describing how communication occurs is important to ensure all requirements are being met. Conflicts of interest: All functions should be joined together under one set of leadership to ensure everyone is on the same team and share the same goals. Also, QM Supervisors should have a mechanism to report directly to leadership, even if they perform other tasks under managerial personnel.

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! Written agreements are very important because third parties impact the product and unit and must understand and comply with requirements. In the written agreements, be sure to reference the Standards. Include the responsibility of the third party to comply with applicable laws and regulations and the Standards, and then provide some specific issues if they are applicable, such as the use of donor screening tests, collections from large organizations and registries such as the Red Cross or NMDP, and processing facilities. It is important to note that the requirement for written agreements does not apply to general suppliers. Programs and banks are required to use a vendor qualification process. A common citation is the lack of written agreements, and the common response is that no written agreements are currently used. If your program or bank does not have any written agreements in effect, it should still include a general description of how you will implement one if it becomes necessary in the future. The description in the QM Plan can be real simple, such as including that the agreements must follow institutional requirements, meet the Standards and applicable laws and regulations, and other general statements. It should give your program or bank a starting point in the event it needs to draft a written agreement. Remember – that is what the QM Plan is for!

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 Tracking and tracing products and units enables the program or bank to investigate issues, document the chain of custody, and obtain information necessary to conduct further testing, particularly in cord blood banks. Tracking is a forward-looking process, where a process is followed from beginning to end. For example, for chain of custody issues, tracking who has the product or unit at what date and time, and who delivered and received it, is tracking the location of the product. Tracing is a backward-looking process, where documents are used to follow the history of a process, product, or service. An example of tracing is the review of the donor selection and evaluation process by reviewing the donor health history questionnaire, lab test results, and physicial exam in the event that an adverse event during a collection procedure occurred.

21 Case Study: CBB Structure
8 CBB Director QM CBB Medical Director Fixed Collection Site Director Donor Processing Facility Director Processing Supervisor Processing Personnel Chart: reporting relationship Dotted lines: External parties Numbers: Tracking and tracing 10 11 9 12 Clinical Program Registry 4 5 6 Testing Laboratories 3 Courier Service 2b 7 This slide illustrates how closely related the organizational chart, written agreements, and unit tracking and tracing are interrelated. A common structure for cord blood banks is used in this example, in which non-fixed collection sites are used in addition to fixed collection sites. As you can see, there are many external parties that greatly affect the quality of the CB unit in addition to the many functions within the bank itself. With all of these separate functions impacting the unit, it is very important to have a defined organizational chart that illustrates the reporting relationship of each party involved. With all of the external parties taking part in the manufacture of a cord blood unit, it is essential that the bank can keep a solid working relationship with them and ensure that they follow all applicable laws and regulations and the Standards and also communicate with the people they report to. This is what written agreements are intended to do. Finally, with the myriad of functions within the bank and external parties, tracking and tracing of the unit is complex. In this oversimplified example, the CB unit follows 12 steps – both within the bank and outside the bank. Being able to track where the unit is at all times, and then being able to trace the history of that unit, is a large task that requires a definitive process for tracking and tracing. Without this process, you could encounter chain of custody issues or difficulty in investigating a nonconforming unit. Non-fixed Sites 2a 1a Collecting Health Professional 1b Donor

22 Personnel Documentation of personnel qualifications and ownership of processes Investments in personnel that increase quality: Education Self-improvement Empowerment Job satisfaction The personnel requirements for the QM Plan are intended to ensure documentation of activities that demonstrate that the program or bank have not only qualified personnel, but individuals have ownership of processes that affect the quality of products or units. This in turn creates an entire staff of “quality personnel” because everyone has a vested interest in the quality of his or her work. Investments in personnel can increase quality through education of the most current scientific findings, self-improvement in daily tasks, empowerment to make a difference to patients, and job satisfaction and the desire to do well.

23 Critical Processes, Policies, and Procedures
Each critical process, policy, and procedure remains accurate, operational, and relevant Development Approval Validation Implementation Review Revision Archival The Standards require that each critical process, policy, and procedure remains accurate, operational, and relevant. There are several requirements for these, and they are listed on this slide. Be careful not to miss any of these requirements! Each of these requirements is for a distinct purpose: Development: Reproducible explanations and steps Approval: Reviewed for accuracy, appropriateness, and completeness Validation: Consistent meeting of specifications Implementation: Operational Review: Based upon current knowledge and practices Revision: Authorized changes when necessary Archival: Prevention of use when obsolete

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! Document control ensures documents used in the manufacturing process are current and protected. This requirement is similar to process control, but is specific to documents such as SOPs, worksheets, forms, and labels. Having a strong document control system ensures processing personnel use appropriate calculations on worksheets, that product and unit labels contain all pertinent information to ensure the right product gets to the right patient, that personnel follow current processes that impact quality, and that all steps on the correct form are completed. It is important to list all types of documents that are subject to the document control system. This direction must be given in the QM Plan, and the inspector will cite you if it is missing.

25 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! This slide illustrates how personnel requirements, process development, and document control all help manage quality. This case study’s example is on infection control, an issue that is revisited every year before the flu season, especially this year as new virus strains have appeared. When an increase in infection is widespread, Clinical Programs’ processes may be inadequate. If personnel are qualified, trained, and educated, they will be capable and empowered to generate new and creative ideas to improve current processes related to infection control. With the process for developing critical processes outlined and referenced in the QM Plan, these new ideas are converted into thoroughly developed, reviewed, and documented processes so that they are effective at preventing infection. Once this process is documented in SOPs and other supporting documents, those documents are protected and controlled to always instruct personnel to follow current infection control procedures – not the ones they used last year that are now outdated! This is a circular process, in which the documents in turn help the personnel that originally created them. This process continues – which is continuous improvement!

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 Analysis of therapeutic outcomes is very important because they 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. [Read slide] DISCUSS HANDOUT 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 Audits simply verify that policies and procedures are implemented and complied with. Remember that the purpose of quality management is not to simply generate paper. All of those policies and procedures must be followed. Audits ensure that they are in fact being followed. Audits are particularly important for clinical programs due to the difficulty validating clinical processes. A timetable, in other words, a schedule, is required in the QM Plan. This can be within the QM Plan or in a referenced addendum or SOP. The timetable should include a combination of specific times (i.e., the month of November) as well as flexible policies (i.e., qualification when new lots are received). Audits should be prioritized based upon the risk of an adverse event, findings from assessment data, the results of surveys, and complaints received. DISCUSS HANDOUT 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 Qualification applies to equipment, supplies, and reagents. The purpose of qualification is to be confident that they function consistently as they are supposed to function. You first need to establish minimum requirements for accepting supplies and reagents and for using equipment, and then confirm and document that the requirements are met before use. It is important to note that qualification does not apply to Clinical Programs and is not listed in the Clinical Program section of the Cellular Therapy Standards. When creating the overall QM plan, remember to include this and validation in that plan even if you use the Clinical Program section as an outline. 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 Validation and/or verification is necessary to confirm through objective evidence that products and units consistently meet specifications. Determine the data to collect first to ensure the evidence is objective. Examples include cell counts, volume, and CFUs – the targets for these should be set before you begin collect the data. Include all of the variables that can impact quality, such as donor WBC, machines used, and the duration of collection. This is to ensure processes are consistent despite the differences that may occur each time it is performed. Compare the collected data to your product or unit specifications to ensure the process results in quality products or units. Again, validation does not apply to Cellular Therapy Clinical Programs but must be included in the overall QM Plan. 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 In your QM Plan, you should keep in mind the different metrics that you will use to perform assessment activities such as validation, qualification, audits, and outcome analyses. [Read slide]

31 Case Study: Investigation of Poor Engraftment Results
Clinical Program reports outcome analysis results: poor engraftment likely due to low cell counts Validation Study Collection procedure validated to achieve target cell counts at time of implementation Qualification Apheresis machine undergoes Operational Qualification (OQ) to ensure it is still functioning appropriately Audit Personnel compliance with collection procedure audited to ensure all necessary steps are followed This slide illustrates how assessment activities all tie together to ensure quality cellular therapy. In this example, the Clinical Program identified poor engraftment results during an outcome analysis. These results were reported to the Collection Facility. The Collection Facility verified that its current collection procedure was validated at the time of implementation as was found to achieve target cell collection counts. The next investigative step the facility took was to perform operational qualification on its apheresis machine to ensure it is still functioning appropriately. The machine was found to still be in compliance with specifications, so the Collection Facility audited its personnel to ensure they are complying with the entire collection procedure. This audit found noncompliance with the procedure, which could have resulted in the low cell counts. Usually these items are undertaken separately, but this example shows that the activities are helpful for investigative steps just as they are helpful as proactive activities. 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 A major role of a Quality Management Plan is to assess regulatory affairs and ensure requirements are met. One of the concerns of the United States FDA is the use of products with positive microbial cultures. The cellular therapy community agrees that the benefits of contaminated products may outweigh the risks if the product can save a life. To be able to use these potentially life-saving products, programs must follow regulatory guidelines. The FACT Standards expand upon them to ensure these products are used appropriately. [Read slide]

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 The requirements for errors, accidents, suspected adverse events, biological product deviations, variances, and complaints have several steps, but they are simply intended to provide the program or bank the ability to detect issues and then correct them, while reporting to the appropriate organizations. Detect: Be able to determine when products or units do not meet product specifications and process controls Investigate: Find the cause by collaborating with all facilities, registries, etc. Document: Written reports, complaint files, review by Director Tracking: Categorizing issues allows identification of systematic problems Report: Notify all facilities, governmental authorities, registries, etc. when appropriate and required Corrective Action: Do not forget to include both short and long-term action and evaluate the action. Commonly Cited! Evaluation: Review all of the information Detailed information regarding this requirement is provided in the recording of the FACT product deviations webinar, which is available on the FACT website.

34 Case Study: Storage Conditions
Detection Evaluation Investigation Documentation Reporting Short-term Corrective Action Long-term Follow-up Activities Low Liquid Nitrogen This slide shows all of the steps needed to take for an error or accident: low liquid nitrogen in a Processing Facility’s tank. Detect: Audible alarm system Investigate: Low liquid nitrogen level Evaluate: Need to move products to functioning freezer to maintain temperature; determine products’ temperatures are acceptable Document: Product records and incident report Report: Processing Facility Director and QM Committee Short-term Action: Move products to back-up freezer and replenish liquid nitrogen Long-term Action: Adjust delivery schedule of liquid nitrogen Follow-up: Audit delivery schedule

35 Continuous Operations
Be able to meet requirements when computer systems fail Critical clinical documents Donor evaluation and consent forms Processing worksheets As more and more processes and documentation are moved to electronic platforms, there is an increasing risk of the loss of documents or terminated access to critical information. Programs and banks must be able to meet operational requirements when their computer systems fail. For example, if an institution’s information technology infrastructure fails, a cellular therapy program may not have access to its document server and electronic medical records. The Clinical Program must have a way to obtain preprinted orders, the Collection Facility must be able to ensure the donor evaluation process was completed and the consent form was signed before initiating a collection procedure, and the Processing Facility must be able to manually perform the same calculations on electronic worksheets A common way to ensure continuous operations is to have a means to access hard-copy medical records, have screen-shots of the current system printed in advance, and have master hard copies of documents and forms.

36 Maintaining a QM Plan

37 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 Maintaining a QM Plan is just as important as establishing and implementing one. Annual review of the QM Plan is required, during which you should ensure that the QM Program is in fact functioning according to the plan. If it is not, you will need to determine if there is a systematic issue that needs to be corrected in your program or bank, or if the QM Plan needs to be revised to be more realistic. The annual review should be done in conjunction with the annual reporting to the Directors – this way, results from tracking and trending activities of audits, validation studies, and outcome analyses can be used to evaluate the effectiveness of the plan. As discussed before, many programs and banks reference the detailed SOPs in their plans. At the time any of those plans are revised, you should review that portion of the QM Plan to ensure the description is still accurate. You should also verify with the QM Plan if the revision of that particular SOP affects any other portion of the QM Plan. It may even spur new ideas for the other sections. After you have mastered the priorities of meeting regulations and Standards and patient care, you can continue to evolve your QM Plans with each annual review into a more sophisticated process by adding more goals and systems to further enhance quality. Finally, remain current with applicable laws and regulations and the FACT Standards. This includes new specific requirements, but also includes guidance documents, announcements, and clarifications. The better you understand the intent of these requirements, the more effective your QM Plan will be.

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 The next couple of slides will go over some common citations regarding QM Plans, and then we will go into specific detail about how to establish, implement, and maintain them. (Remember – these citations do not include specific deficiencies related to required elements within the QM Plan.) One common citation is in regards to the overall QM program required of Clinical Programs in the Cellular Therapy Standards. Clinical Programs are required to have an overall QM program that incorporates the information from the clinical, collection, and processing facility quality management programs. Sometimes, a clinical program may use information from collection and processing facilities, but there is no documentation of this in the QM Plan. Sometimes there are separate QM programs between the three functions, which is acceptable, but there is no integration of the information that enables the QM program to look at the entire manufacturing process. Finally, sometimes there is simply a lack of an overall QM program. Organizational charts are required by the QM Standards. Sometimes they are vague or incomplete; for example, they are missing a whole department, such as the marrow collection. Sometimes they misrepresent the actual functioning of and interactions within the program, such as one that showed a Processing Facility reporting to a Clinical RN, who has no day-to-day involvement with the Processing Facility. Sometimes there is simply no organizational chart. Sometimes, a chart exists but it is weak and displays a lack of interaction from various program or 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 The Cellular Therapy Standards require a description of how key personnel interact to implement the quality management activities in addition to the organizational chart. This description is often missing. It can be accomplished by including bullet points on the organizational chart itself, or in paragraph form in the QM Plan. Clinical Program Directors, Collection Facility Directors, Processing Facility Directors, and Cord Blood Bank Directors are ultimately responsible for the QM program. However, the day-to-day tasks are often delegated to another individual. Common deficiencies relate to this delegation. Sometimes, the QM Plan does not provide any allowance for delegation and states that the Director is responsible for the activities when in reality a designee is the responsible party. The QM Plan often does not have a clear designation of who is actually responsible. Sometimes, especially in small programs, the Director truly is responsible but there is little evidence of involvement in those activities.

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 This slide lists some of the commonly missing elements during FACT inspections. Missed elements translate into citations. [Read slide] [FYI – outcome analysis: Each component of the program does not have to track engraftment (Clinical Program is usually the only facility able to collect the info), but it still needs to be reported to collection and processing] [FYI – microbial cultures: This may be considered by a program or bank to be a biological product deviation, yet special attention is given to it in the Standards because of the US FDA’s stance on the issue.]

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 Presenter – Kara Thank you for joining us today. This was the second session of the Administrative Aspects of QM module. Join us for the upcoming sessions in this module, which include a virtual roundtable on time, effort, and resources for FACT accreditation and a tutorial on the SOP for SOPs to be released in November. Also, our next module, Quality Management Monitoring and Assessment Activities, will begin in the winter of This module will include sessions dedicated to providing specific details regarding activities such as outcome analyses, validation studies, qualification, and audits. Stay tuned to the FACT website and newsletters for more details!

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 Presenter – Kara Continuing Medical Education and Continuing Nursing Education credits are available for this webinar. All certificates are accessed via an online portal system. FACT will cover continuing education credit expenses for its inspectors, and inspectors can access the online system via the Inspector Area on the FACT website. Program and bank personnel who are not inspectors can access the online system via the webinar page on the FACT website. We appreciate any feedback you have to help us improve our training and development offerings in the future. Participants who do not wish to receive continuing education credit will be sent an with a link to an evaluation. As always, if you have any questions about continuing education credit or other issues, feel free to contact the FACT office.

43 Question and Answer Session
Presenter – Kara We will now begin the question and answer session. You may ask questions in two different ways. You may type your question in the box found under the Q & A menu at the top of your screen, or you may ask a question verbally by indicating that you have a question by selecting the lavender box under the feedback menu at the top of your screen. I will moderate the session and direct the presenters to the specific questions. We will begin with the typed questions and then move to verbal questions. We welcome any questions you may have, as valuable information can be shared in their answers. [Answer electronic questions] Now we will begin the verbal questions. When your name is called, please press *6 to unmute your line. After your question has been answered, press *6 again to re-mute your line.

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