Updated: 9/3/2008

Mayo Medical Laboratories’ core quality principle is the continuous improvement of all processes and services supporting the care of patients. To support this principle, we developed a comprehensive Quality System, outlined by our Framework for Quality based on the Clinical and Laboratory Standards Institute (CLSI) HS1-A2 and GP26-A3 consensus standards and also on programs and measurements such as Lean and Six Sigma.  The Quality System allows us to deliver consistent, cost-effective and superior service to our clients. The system is comprised of 12 Quality System Essentials (QSEs). The policies, processes and procedures associated with these QSEs are applied to all operations in the path of workflow (e.g., pre-analytic, analytic and post-analytic). Quality management focuses on continuous quality improvement as measured by customer satisfaction.

Operating within a Quality System allows us to meet and exceed the requirements of regulatory/accreditation agencies and facilitates service satisfaction for our customers. We have defined processes for planning and evaluating the effectiveness and efficiency of our Quality System through scheduled internal audits, quality performance monitoring, and leadership reviews.

Quality System Essentials

Structure	Process	Outcome
Organization Structure Mission Leadership Review Resources Facilities and Safety Safety Programs Personnel Job Qualifications Job Description Orientation and Training Competency Continuing Education	Purchasing and Inventory Critical Materials and Services Qualification of Suppliers Maintenance of Inventory Market Recall Equipment Selection and Acquisition Installation Qualification Operations and Calibration Maintenance and Repairs Process Control Validation Process Monitoring Quality Control Change Control Documents and Records Document Creation Change Control Annual Review Numbering and Master Index Record Quality and Review Retention, Storage and Retrieval Information Management* Training and Reference Guides Software Interface Testing	Event Management Detection,         Documentation and Investigation Categorization and Analysis Assessment Quality Indicators Internal Assessments External Assessments Proficiency Testing Quality Reporting Service and Satisfaction Surveys Customer Comments Consultation Needs Assessments Process Improvement Opportunities for Improvement Quality Management Tools

*In Development

Quality Indicators

Mayo Medical Laboratories produces hundreds of Key Performance Indicators for our business and operational areas, and we review them regularly to ensure that we continue to maintain our high standards. A sampling of these metrics includes:

Pre-analytic performance indicators

• Lost specimens*
• On-time delivery
• Special handling calls
• Specimen acceptability*
• Specimen identification*

Analytic performance indicators

• Proficiency testing
• Method validation
• Turnaround (analytic) times
• Quantity-not-sufficient (QNS) specimens

Post-analytic performance indicators

• Revised reports*
• Critical value reports*
• Tests down/delays

Operational performance indicators

• Incoming call resolution*
• Incoming call abandon rate
• Call completion rate
• Call in-queue monitoring
• Customer complaints
• Customer satisfaction surveys

*Measured using Six Sigma defects per million (dpm) method.

The system provides a planned, systematic program for defining, implementing, monitoring and evaluating our services.

Quality Improvement Programs

Mayo Clinic encourages innovative thinking and promotes high performance in daily operations. Our values and mission guide our interactions with our patients and customers. Continuous improvement is a constant process. Mayo Medical Laboratories and Mayo Clinic’s DLMP employ systems engineers who are Six Sigma Green Belts and Black Belts. They work to improve laboratory procedures and enhance overall operations performance.  More than 100 individuals within Mayo Clinic are trained in the use of Lean principles, a systematic approach to analyzing the flow of information and materials in order to eliminate waste, process variation and imbalance in their work areas. We have performed multiple process improvement projects using Lean thinking. We also have a dedicated team at a master level in Lean. This team of system engineers and master schedulers uses Lean tools to enhance and streamline processes and procedures.

Mayo Medical Laboratories strives for continuous improvement that constantly enhances value to the customer. This is achieved by defining value from our customers’ perspective.  Specifically, we rely on Six Sigma practices including project management, FMEA (failure modes and effects analysis), process mapping, statistical analysis, design of experiments, cause and effect matrix/diagrams, control charts, 5 “whys,” capability analysis, and control plans.

Our best demonstration of quality and customer satisfaction is our extremely high client retention rate. Client satisfaction is also documented and monitored regularly. A priority at Mayo Medical Laboratories is efficiency in interpreting and applying esoteric laboratory results to the patient’s clinical situation. Our clients’ patients benefit from access to the comprehensive resources of Mayo Clinic, and physicians realize value in the collegial relationships developed with peers at Mayo Clinic.

Assessments/Proficiency Testing

We participate in both internal and external assessments.  Performance is measured through the use of quality indicators, CAP Q-Probes® and CAP Q-Tracks®.  We also participate in a wide variety of proficiency testing to assure the accuracy of test results.  In addition, we participate in external assessments that include, but are not limited to, regulatory inspections, accreditation assessments, and clinical trial audits.  An internal audit program also monitors operations and the quality system.  It is designed to assess the effectiveness of the quality system, validate new and existing processes, and assess the adequacy of standard operating procedures.  These programs include the monitoring of procedures through quality control, proficiency testing, quality indicators and the assessments described above.

Mayo Medical Laboratories’ interlaboratory proficiency testing includes these independent state, national and international programs:

• AABB Immunohematology Reference Laboratory
• American Association of Bioanalysts (AAB)
• The Binding Site
• Centers for Disease Control and Prevention
• College of American Pathologists Surveys
• Health Canada Interlaboratory Comparison Program
• International Tay-Sachs Program
• Laboratorie de Biochimie et de Toxicologie (International Aluminum Quality Control)
• Le Centre de Toxicologie du Quebec, Quality Assessment Scheme
• Le Centre de Toxicologie du Quebec, Comparison Program
• New York State Department of Health
• Pennsylvania State Department of Health
• Vitamin D External Quality Assessment Scheme
• Cystic Fibrosis European Network
• EMQN EQA Scheme
• Women & Infants Hospital (WIH) First Trimester Interlab Comparision Program (ICP)

Additionally, we conduct internal assessments to ensure the accuracy and reliability of patient testing when interlaboratory comparison is not available — or additional quality monitoring is desired. We comply with the regulations set forth in Clinical Laboratory Improvement Amendments (CLIA-88). Mayo Medical Laboratories has no sanctions from CLIA-88, the Occupational Safety and Health Administration (OSHA), or the Center for Medicare and Medicaid Services (CMS).