Biorepository Accreditation Services. CAP BAP Accreditation Services
Background
The VA Central Biorepository, located at the Massachusetts Veterans Epidemiology Research and Informatics Center (MAVERIC), VA Boston Healthcare System, conducts human specimen processing and storage services for multiple research studies. The Biorepository has been tasked with the responsibility of processing over one million blood samples on behalf of the Million Veteran program (MVP). Important to the mission of the Central Biorepository is adherence to standards and best practices to ensure the production of high quality specimens for research purposes. The International Society for Biological and Environmental Repositories (ISBER) has developed consensus best practices that reflect the collective experience of its members. Also, the National Cancer Institute (NCI) has developed best practices for biobanking. The College of American Pathologists (CAP) has instituted a program specifically for the accreditation of biorepositories (CAP BAP) that incorporates the wisdom of both ISBER and NCI. A specific goal of the Central Biorepository is CAP BAP accreditation. Toward this goal, the Central Biorepository has implemented a Quality Management System (QMS).
Scope
The Central Biorepository is requesting the services of a vendor to assist with implementation of the QMS and achievement of CAP BAP accreditation. The Contractor should have thorough knowledge of CAP BAP programs and ISBER practices, and have experience in establishing QMS in biorepositories. Proficiency in providing high quality, high throughput genomic resources, and integrating robotic automation processes into biobanking will also be needed to successfully provide support for the Biorepository in achieving accreditation. Improvements to biospecimen processing procedures, sample inventory management, error tracking, quality control, inspections, and document control will be put into place. The Contractor shall engage the Biorepository staff to understand all processes and operations to be governed by the QMS, institute best practice standards (which may include practices not contained in CAP BAP checklists), and thoroughly prepare for the official CAP BAP accreditation audit. The Biorepository has registered with CAP and has acquired the CAP BAP checklists to enable the Contractor to perform the services described herein.
Tasks shall be performed at both Contractor facilities and in the VA facility located in Boston VA Healthcare System (VAHCS) MAVERIC.
Applicable Directives:
Contractor shall not be expected to perform VA training for access to Biorepository spaces, as the Contractor shall be under constant supervision and escorted by VA staff.
Contractor shall be expected to adhere to local VA and government guidelines and regulations applicable to any on-premises work.
Contractor shall submit all reports, documents, and other deliverables to the Biorepository Quality Team as identified below in the Deliverables section below.
Current Compliance/Accreditation Status
There have been no inspections of the Biorepository thus far by CAP. An initial gap analysis was performed at the time the Biorepository registered with CAP, and before the implementation of the QMS. Significant progress has been made in developing documents and processes to align with CAP BAP requirements, and the QMS is in the initial stages of implementation. A Biorepository Quality Manual (QM) containing Biorepository Policies has been completed, a milestone which is integral to CAP BAP accreditation.
Deliverables
Year 1: October 1, 2017 September 30, 2018
Contractor shall perform an initial review of the current Biorepository QMS, which includes Policies (Quality Manual), Procedures (Work Instructions, Job Aids, Standard Operating Procedures), Proofs (Forms, Logs, Records, and Software that document performance), and Processes (actual processes performed). This review shall be completed within two months of the contract award date.
Contractor shall perform a site visit to the Biorepository, if the Biorepository and Contractor agree this visit is necessary for a thorough review and analysis of Biorepository practices. A written summary of findings shall be delivered to the Biorepository within two weeks of completion of the site visit.
Contractor shall work with Biorepository staff to develop a strategy for a desk audit of the QMS. The desk audit shall determine alignment of the QMS with CAP BAP requirements. Contractor shall deliver a written, customized audit checklist for the Biorepository to review prior to the audit. The checklist shall be delivered within three months of contract award date.
Contractor shall conduct the desk audit of the Biorepository within four months of contract award date. A written report including a summary of audit results, gap analysis, and remediation plan shall be delivered to the Biorepository within two weeks of completion of the desk audit.
Contractor shall develop a roadmap with timelines for completing tasks required for CAP BAP accreditation. These tasks shall include, but are not limited to, the drafting of documents, creation of training and assessment materials, customer satisfaction assessment, disaster response and recovery, equipment management, biospecimen management, and information management. Contractor shall identify and document success measures. This roadmap may be in the form of Gantt chart or other project management tool.
Contractor shall identify required costs, staffing, and logistics to achieve accreditation goals. Contractor shall advise the Biorepository on developing a budget for implementing the QMS, maintaining the QMS, and achieving CAP BAP accreditation. Contractor shall also assist the Biorepository in determining requirements for additional personnel needed to implement and maintain the QMS, and achieve CAP BAP accreditation.
Contractor shall advise and assist Biorepository in the writing of Work Instructions for various lab processes. The number of Work Instructions to be completed will be dependent upon the results of the gap analysis, updates to Biorepository procedures, and further implementation of the Biorepository QMS.
Contractor shall work with the Biorepository to develop a system of quality control checks for Biorepository processes. Reviews of progress on this task will be conducted monthly by the Biorepository once this work commences.
Contractor shall work with the Biorepository to develop a system of error tracking for Biorepository processes. Reviews of progress on this task will be conducted monthly by the Biorepository once this work commences.
Contractor shall provide suggestions for modifications to Biorepository information management software so that CAP BAP requirements are met. Contractor shall also assist in the development of written software user guides and training manuals. The Biorepository has configured and installed a Commercial of the Shelf (COTS) Laboratory Information Management System (LIMS), called STARLIMS (an Abbot Company). The LIMS helps to optimize sample accessibility, data management, data integrity and data security.
Contractor shall review Biorepository workflows and provide strategies from improvement as requested. Examples and models shall be included as applicable.
Contractor shall advise the Biorepository and deliver written reviews on the suitability of Biorepository policies, procedures, work instructions, standard operating procedures, forms, and other quality records with regard to alignment with CAP BAP standards. These reviews shall include Biorepository procedures to conduct quality audits, document deviations and nonconformance, and institute corrective and preventative actions. Examples and models shall be included as applicable.
Contractor shall, upon receiving input from the Biorepository, shall redesign suggestions or strategies based on this input, while maintaining compliance with CAP BAP requirements and VA regulations.
Contractor shall develop a plan so that the Biorepository can maintain the QMS and continually follow best practices.
Year 2: October 1, 2018 September 30, 2019
Contractor shall perform a site visit to the Biorepository to conduct a mock CAP BAP accreditation audit. A written summary of audit findings and gap analysis shall be delivered to the Biorepository within two weeks of the completion of the site visit.
Contractor shall provide written reviews of the Biorepository Quality Manual (Policies) and Training Manual (Work Instructions, Job Aids, Standard Operating Procedures, and other training materials).
Contractor shall provide a written review of the Biorepository Orientation Program.
Contractor shall advise and assist the Biorepository in developing a system to track biospecimen inventory. This system will track the following information on biospecimens: accession, blood processing, DNA extraction, DNA quality control, DNA sorting (i.e. DNA is acceptable , DNA to be re-purified , DNA to be re-processed ), storage location, and shipping. The system will also track processing and quality control of plasma, serum, saliva, and other biospecimen types, if applicable. The system will track and summarize the number and identity of biospecimens that fail and that require re-processing. Reasons for sample failure and re-processing and associated trends will be included in this system.
Contractor shall assist Biorepository in developing a system of Quality Indicators (e.g. Management Review) for Biorepository performance.
Deliverables listed above for the Base Period shall continue as necessary.
Year 3: October 1, 2019 September 30, 2020
The Biorepository plans to schedule an official CAP BAP accreditation audit by the end of FY20.
Deliverables listed above for the Base Period and Option Year 1 shall continue as necessary.
Contractor shall perform a site visit to the Biorepository to conduct an inspection and pre-CAP BAP accreditation audit. A written summary of audit findings and gap analysis shall be delivered to the Biorepository within two weeks of the completion of the site visit.
Contractor shall perform a site visit to the Biorepository at the time of or just prior to the official CAP BAP accreditation audit, if requested by the Biorepository. The purpose of this site visit is to advise the Biorepository and provide final preparation for the CAP BAP audit.
Contractor shall deliver a final status report stating that, in the expert opinion of the Contractor, the Biorepository is prepared for the official CAP BAP audit and qualified for CAP BAP accreditation.
Contractor shall develop a plan so that the Biorepository can maintain CAP BAP accreditation, maintain the QMS, and continually follow best practices.
Contractor shall develop a mechanism to monitor new regulatory requirements and changes in existing ones.
Year 4: October 1, 2020 September 30, 2021
This option is included for additional work toward CAP BAP accreditation and/or remediation if the Biorepository fails to achieve CAP BAP accreditation in Year 3, or if the accreditation audit cannot be conducted by the end of Year 3.
Quality Metrics
The Biorepository QMS will be developing throughout the entire performance period of the contract; therefore, the Contractor may be asked to review a component (document, process, proposal, quality record) of the QMS at any time. When a task has been identified, the Biorepository and Contractor shall arrive at a mutually agreed upon delivery schedule.
The Biorepository QMS completed by the end of the contract shall contain the rules, statutes, and scope of work the Biorepository will follow to ensure standardized and consistent processing of biospecimens.
Contractor shall provide written reviews of Biorepository QMS components when requested. These reviews shall be delivered at a time mutually agreed upon by the Biorepository and Contractor.
Contractor shall provide periodic performance and status reports to the Biorepository at least once every other week. These reports can be in the form of a conference call.
In addition to conference calls every other week, Contractor communications shall include monthly status reports, monthly budget reports, and progress and milestone review meetings, as requested.
Contractor shall respond to telephone calls and emails within two business days.
Contractor shall maintain a library of presentation and reference materials, as applicable.
Contractor shall deliver all reports and documentation in writing to the Biorepository and Contracting Officer Representative (COR).
Email Only; No Phone Calls.
cheri.wicks@va.gov
Contracting Officer's Email
