Tissue Quality Assurance Manual

TABLE OF CONTENTS –TISSUE QUALITY ASSURANCE MANUAL A. Management Plan for Quality Control/Quality Assurance A.1. Quality Assurance by Committee Overview A.2. Coordinating Committee A.2.1. Coordinating Committee Subcommittees A.3. Subcommittee Agendas A.4. Coordination of Committee Meetings A.4. Quality Assurance by On-Site Compliance Review

A. Management Plan for Quality Control/Quality Assurance Quality control is best managed by documented Standard Operating Procedures (SOPs) that exist in an electronic format and accessible to all involved parties in real time. Throughout our proposal for “Tissue Collection” we have supplied SOPs to guide the workflow process. These documents will be available electronically via the LIMS for all Network Sites. Quality Assurance refers to the process used to create these deliverables (SOPs), and can be performed by a manager, client, or even a third-party reviewer. Most importantly for a project such as this quality assurance involves open communication about problems and systematic ways to address and correct such concerns. In this context the key to quality assurance for the TDAN includes scheduled meetings with 1) defined topics of discussion, 2) minutes of all meetings, 3) appointed action items, and 4) follow-up.r Second, quality assurance which is so important for solidifying and implementing SOPs requires communication between all involved parties. Even in today’s era of modern communications face to face meetings are required on a routine basis to have a coherent group. Our overall quality assurance program will focus on a proposed system of •

yearly meetings

•

quarterly conference calls

•

properly trained personnel

•

focused management groups

•

key points of contact for specific problems.

A.1. Quality Assurance by Committee Overview: The overall plan for directing the TDAN is a collaborative agreement between the DOD, TRI and all Network Sites via a Coordinating Committee (Section A.2) (Figure 1). This committee will establish and agree upon a comprehensive set of standards that will then be implemented by each Network Site. Within the Coordinating Committee are multiple Subcommittees (Section A.2.1) to address specific issues more pertinent to some members than others. It will be the charge of the Coordinating Committee to develop a Charter within the first six months of operation. A.2. Coordinating Committee: The Coordinating Committee (Figure 1) consists of the PI and all Co-PIs and designated staff at each site. The Coordinating

Coordinating Committee

PI & Co-PI(s) Network Sites

Figure 1

Executive Subcommittee

Strategic Planning Subcommittee

Operations Subcommittee

Coordinating Center PI & Co-PI

Network Manager TRI

Network Manager, Site Coordinator(s)

Quality Control Subcommittee

Biospecimen Subcommittee

Procurement Specialist

Regulatory Affairs Subcommittee

Administrative Manager

Informatics Subcommittee

Data Manager & Data Management Specialist(s)

Committee’s primary responsibility is to harmonize, coordinate and implement all SOPs approved by the Steering Committee. Standards for training of staff will be a part of this meeting.. The Coordinating Committee will meet twice the first year and annually thereafter. Additional meetings may be held, if necessary. The meeting sites, dates and time will be chosen by the TDAN PI in mutual agreement with other Co-PIs. Coordinating Committee meetings will generally last for one and a half days. The Coordinating Committee at its first meeting will be responsible for developing an agenda that can be closely followed at each meeting. The PI has at his resource example agendas that can be used as templates for these meetings (Section A3). The travel budget for TRI faculty and staff will be the responsibility of the TRI budget. The travel budget for Network Sites faculty and staff will be the responsibility of Network Sites budget. Coordinating Committee meetings will be held at each of the six Network Sites on a rotating basis. In addition to agenda items this will allow for each Network Site to identify potential workflow improvements at their own site. A.2.1. Coordinating Committee Subcommittees: The Coordinating Committee will have multiple subcommittees very similar to the Cooperative Human Tissue Network that include: • Executive Subcommittee – responsible for overall harmonization of all other subcommittee actions • Informatics Subcommittee – responsible for all issues related to informatics including equipment and training of personnel • Biospecimen Subcommittee – responsible for all issues related to biospecimens • Operations Subcommittee– responsible for all issues related to budgets, development and operations including equipment and training of personnel • Quality Control Subcommittee – responsible for all issues related to review of quality control procedures including equipment and training of personnel • Regulatory Affairs Subcommittee – responsible for all issues related to local IRB approval, consent, HIPAA coordination and oversight etc • Strategic Planning Subcommittee – responsible for all issues related to future endeavors of the TRI. Each subcommittee will be responsible for developing a refined agenda worksheet that clearly defines and guides the responsibilities of that particular subcommittee (Section A.4). In addition to the annual Coordinating Committee meeting each subcommittee will be required to have scheduled conference calls as needed to address current issues. A.3. Subcommittee Agendas: Committee meetings are most efficiently directed by specific topics of discussion. Each topic is defined by specific action items (challenges or barriers) to implement the issue being discussed. Each specific action item in turn should be assigned to one or more individuals for follow-up. All of this activity should be documented using specific written formats. In this regard we have supplied the following example agenda formats for each subcommittee that can be refined at their discretion (Appendix IV): Executive Subcommittee – responsible for overall harmonization of all other subcommittee actions • Informatics Subcommittee Meeting • Biospecimen Subcommittee Meeting • Operations Subcommittee Meeting • Quality Control Subcommittee Meeting • Regulatory Affairs Subcommittee Meeting • Strategic Planning Subcommittee Meeting. A.4. Coordination of Committee Meetings: The TRI Administrative Manager will be responsible for coordination of all meetings. Responsibilities include: 1) Plan and conduct Committee Meetings – 1) Establish location for meeting, and make necessary arrangements for conference facilities and accommodations for participants, and 2) Prepare draft agenda and distribute for comment/additions. 2) Minutes - Prepare and distribute minutes, including a list of Action Items to be carried out.

A.4. Quality Assurance by On-Site Compliance Review: The PI of the TRI and other select TRI faculty and staff will visit each Network Site 2 times per year. The initial one or two visits will be instructional and serve to answer any questions about SOPs. As procedures become routine during the latter part of the first year these visits will serve as an on-site compliance review. The PI will develop a checklist of compliance parameters and the Network Site will receive a formal written report at the end of year 1, mid-year 2 and mid-year 3. This process will function in a manner similar to the CAP Laboratory Accreditation Program whereby the Network Site will have prior written documents describing a list of compliance items to be reviewed. Items on this list will be graded from minor to major violations. An example of a major violation would be failure to procure the minimum number of samples that pass quality control review. An example of a minor violation would be failure to completely annotate specific data for a given sample. The Coordinating Committee will be responsible for developing a series of strategic changes as a result of a maximum number of minor or major violations by any Network Site.