The Department of Pathology uses the Clinical and Laboratory Standards Institute (CLSI)’s Quality Management System as its comprehensive quality model for laboratory services. This system consists of twelve Quality System Essentials (QSE’s):
QSE Organization describes key leadership responsibilities that are integral to a laboratory’s success in achieving and maintaining a systematic approach to quality and meeting regulatory, accreditation, customer, and internal requirements.
QSE Customer Focus describes the laboratory’s identification of its customers and their expectations, and the need to design work to meet those expectations and any applicable requirements. It also describes methods to seek customer input to confirm expectations are continually being met.
People are the most valuable resource of the organization. QSE Personnel provides information about obtaining and retaining an adequate number of qualified, well-trained, and competent laboratory staff to perform and manage the activities of the laboratory.
QSE Purchasing and Inventory describes agreements that the laboratory has with entities it provides services to and entities from which it obtains products and services to ensure that specified requirements are consistently met.
QSE Equipment describes selection and installation of equipment, equipment maintenance and calibration, documentation of equipment-related problems, and record maintenance to ensure that equipment performs as expected for its intended use.
The QSE Process Management describes policies and processes for all work operations in the laboratory’s path of workflow. It involves all 12 QSE’s in some manner, because processes transform policies into action.
QSE Documents and Records describes the creation, management, and retention of policy, process, procedure, forms and template documents for the QSEs and path of workflow and records generated as a result of performing the activities in the laboratory’s Quality Management System.
The QSE Information Management provides guidance for managing internal and external data and information generated and entered into a paper-based or electronic recordkeeping system (e.g., patient demographics, examination results and reports, interpretations) and disseminated electronically or otherwise to users or other computer systems (e.g., verbal requests, printing, automatic faxing, e-mail, interfaces).
The QSE Assessments describes the use of external and internal monitoring and assessment to verify that laboratory processes meet requirements and to determine how well those processes are functioning.
The QSE Continual Improvement describes mechanisms for identifying opportunities for improvement and use of a defined strategy for CI. CI is critical to optimizing the effectiveness of the QMS and for sustaining quality.