Quality Management

B.3.1. Quality Management System

Biospecimen collection, processing, management, and distribution should be carried out within a quality management system (QMS) that contains documented quality assurance/quality control (QA/QC) policies and written SOPs. Where feasible, the QMS should be managed by individuals who are not involved in repository operations, although this might not be possible for smaller or less established biospecimen resources. The QMS describes the biospecimen resource’s QA/QC policies and approaches for ensuring that program requirements are met. Each biospecimen resource should either establish a written QMS or adhere to a QMS published by the organization with which the biospecimen resource is associated. There are several common quality management programs available upon which to pattern individual biospecimen resource QMS policies. No particular approach is recommended, but several are mentioned below to help design the appropriate QMS for the biospecimen resource. When a resource is considering a quality management program, and choosing between GLP, CLIA and ISO, there are many considerations such as if the resource has legal obligations to state and federal laws, type of resource, cost, and many other variables. One size quality program does not fit all.

The following Web sites are relevant to the development of a QMS:

• ISBER
  http://www.isber.org
• Good Laboratory Practices
  http://www.oecd.org/chemicalsafety/testing/goodlaboratorypracticeglp.htm
• Clinical Laboratory Improvement Amendment
  http://wwwn.cdc.gov/clia/
• International Organization for Standardization (ISO9001:2008, 2015)
  http://www.iso.org
• U.S. Food and Drug Administration (FDA) Quality System Regulation, 21 CFR 820
  http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm?cfrpart=820

B.3.2. Quality Assurance/Quality Control

Formalized QA/QC policies should be developed by biospecimen resources to minimize circumstances that could adversely affect scientific results; to ensure the safety of personnel; to aid in the efficient operation of the resource; and to increase the confidence of users that the quality, quantity, and annotations of the biospecimens are as purported. QA/QC policies should be customized for the intended and potential uses of the biospecimens in a given biospecimen resource. QA/QC implementation should ensure that accurate data accompany biospecimens that are to be analyzed for diagnostic as well as research purposes. The following are key issues for QA/QC implementation and auditing:

• Staff proficiency
  • Staff organization and responsibilities.
  • Training and competency programs for personnel as appropriate; e.g., training in human subjects protections and privacy regulations such as the Health Insurance Portability and Accountability Act (HIPAA) training, safety training, or bloodborne pathogen training.
  • Competency assessment as documentation of training.
  • Documentation of staff compliance with policies and procedures.
  • Risk mitigation, disaster response, and emergency preparedness.
• Facility infrastructure
  • Equipment validation and change control, calibration, maintenance, repair procedures, and environmental monitoring; e.g., temperature monitoring of freezers.
  • Supplier management program, including inspection and validation of reagents and other supplies.
• Biospecimen control and documentation
  • Control of biospecimen collection, processing, and tracking.
  • Documentation of biospecimen collection, processing, and tracking, with detailed annotation of pre-analytical parameters (see Section B.6, Biospecimen Resource Informatics).
  • Measurement and analysis of key process indicators to drive quality improvement.
  • System security.
• Recordkeeping and document control
  • Employment of a data quality management, assessment, and reporting system.
  • Clinical data records.
  • Accessibility of policies and procedures.
  • Documentation records, including audit reports, deviation reports, and corrective action/preventive action reports.
  • External document monitoring to ensure that the facility remains up to date with relevant laws, standards, and best practice publications.
  • Staff training records, including record of staff adherence to training schedules.
  • Data quality management (source documentation and electronic records), assessment of reporting system.
  • Supply records.
• Internal audit of program and its policies, scheduled and unscheduled
  • Audit for accuracy of all annotation data; e.g., the biospecimen is where it is purported to be, in the purported volume, with the appropriate labels/identifiers.
  • Audit for accuracy of patient data associated with biospecimens; e.g., age, gender, diagnosis, etc.
  • Audit of compliance of biospecimen resource with institution policies; e.g., human subjects and privacy and confidentiality protections, prioritization of biospecimen use, etc.
  • Audit of SOPs for all activities and processes.
    • Each biospecimen resource ensures that SOPs are written, reviewed, and appropriately approved.
    • Process exists for review and updating at designated time intervals.

B.3.3. Standard Operating Procedures Manual

Each biospecimen resource should develop SOPs that state policies and describe relevant processes in detail. Additionally, a document control program and policies for governing, modifying, or revising SOPs should be at each biospecimen resource. All SOPs should be reviewed on a periodic basis or whenever significant changes in practices, procedures, technology, law, or regulation necessitate an update. The SOPs should be well structured and undergo a rigorous approval process. Upon implementation, all SOPs should be followed as written. Current copies of SOPs (SOPs manual) should be stored in designated locations and available to personnel at all times. Personnel should review new and revised SOPs prior to implementation; reviews and associated trainings should be recorded. Generally, especially for larger biospecimen resources which have the personnel to support a more comprehensive QMS, an electronic document control system should be implemented. One example is MasterControlTM , which is described on their web site [55]:

Note that the mention of any particular product such as MasterControl does not comprise an endorsement by the NCI.

B.3.3.1. Contents