Certifications
Laboratory Licensure & Quality Programs
QDx Pathology Services is a fully accredited national, CLIA-certified laboratory We are licensed to perform laboratory testing for providers, medical centers, and hospitals throughout the nation, in all 50 U.S. states. In addition, we are accredited in the following states that require state CLIA certification.
QDx is CAP accredited and subscribes to CAPs proficiency testing program that includes verification of testing performance and professional proficiency against pre-analyzed samples. The CAP proficiency programs supplement QDx internal quality management system, ensuring that the testing and professional consultative services we provide you are accurate, precise and reliable.
The CAP programs are built on more than a half-century of experience, the CAP’s Laboratory Accreditation Program has been the champion of laboratory excellence. CAP is recognized as the global leader in improving the quality of pathology and laboratory services using established performance standards. CAP programs provide an engaging, dynamic, collaborative process that fosters an environment of continuous improvement.
QDx Quality Management System
QDx is committed to providing the highest level of quality and service to its provider customers and their patients. That commitment is embodied in our practice of the 12 essential quality control and quality management processes:
- Organization: QDx leadership, employees and QMS staff are committed to and organized around a formal quality management system.
- Personnel: Leaders and staff are trained and continually assessed for competency of duties and tasks with associated documentation. QDx QMS director ensures the organization maintains a focus on quality management.
- Equipment: Equipment monitoring, preventive maintenance, performance verification and environmental monitoring are key elements of our continuous management process.
- Purchase & Inventory: Inventory management processes in place at QDx are aligned with our test production needs and certification requirements to prevent service disruption and ensure high quality materials are used.
- Process Control: QDx has established a structured validation and verification process for testing methods, equipment and operations software. Sample tracking systems ensure a “chain of custody” is verified from collection to testing and storage.
- Information Management: Electronic and data policy control systems ensure medical and patient data are secure. Roles based data access controls and electronic surveillance along with protections from external intrusion ensure data is securely managed and stored.
- Documents & Records: SOPs form the foundation of the essential documents required to ensure processes are accurately documented and followed. QDx records and maintains daily records on test QA, environmental conditions and other vital performance indicators.
- Occurrence Management: Errors or non-conforming events are recorded and evaluated at department, management and executive level. The Director of QMS tracks, analyzes and reports occurrence data to the management team and laboratory leadership.
- Assessment: QDx employs a combination of external and internal resources to assess staff, equipment and test method proficiency including CAP proficiency materials, internal staff competency standards audits and daily testing method QC review protocols.
- Process Improvement: Integrated workflow mapping, Six Sigma Lean assessment and 5S are examples of process improvement methods used to continuously improve QDx performance and service quality.
- Customer Service: Through its dedicated field and home-based customer service team, QDx strives to understand its customers experience and integrate lessons learned from customer feedback and service-based data analytics.
- Facilities & Safety: QDx, through its safety officer and safety policies and procedures, works to ensure a safe and appropriate work environment. Periodic safety inspections and drills ensure employee awareness of policies and prevention measures.