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