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Quality and Compliance

Updated: 03/14/2013


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 Management System, outlined by our Framework for Quality that is based on the Clinical and Laboratory Standards Institute (CLSI) and GP26-A4 consensus standards and also on programs and measurements such as Lean and Six Sigma. The Quality Management System allows us to deliver consistent, cost-effective and superior service to our clients. The system is comprised of 12 Quality System Essentials (QSEs) and organized by structure, process and outcome essentials. 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.

Quality System Essentials




Organization and Leadership

  • Structure
  • Mission, Vision, Value
  • Leadership Review
  • Resources

Facilities and Safety

  • Structure and Utilities
  • Environmental Conditions
  • Communications
  • Safety Programs
  • Emergency Management


    • Staff Qualifications
    • Job Description
    • Orientation and Training
    • Competency
    • Continuing Education



Purchasing and Inventory

  • Critical Materials and Services
  • Supplier Qualification
  • Supplier/Customer Agreements
  • Inventory Management
  • Market Recall


  • Selection and Acquisition
  • Equipment Qualification
  • Operations and Calibration
  • Maintenance and Repairs

Process Management

  • Process Design and Development
  • Validation
  • Performance
  • Quality Control
  • Change Control

Documents and Records

  • Document Creation
  • Use and Maintenance
  • Annual Review
  • Document Control
  • 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
  • External Notification
  • Product/Result Recall/Correction

Monitoring and Assessment

  • Quality Indicators
  • Internal Audit Program
  • External Inspections/Assessments
  • Proficiency Testing
  • Quality Reporting

Service and Satisfaction

  • Needs Assessments
  • Customer Comments
  • Consultation
  • Complaint Resolution

Continual Improvement

  • Data Analysis
  • Identification of Opportunities for  Improvement
  • Quality Management Tools
  • Process Improvement

*In Development

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 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

  • Incoming defects*
  • Lost specimens*
  • MayoTrac™ Compliance
  • On-time delivery
  • Specimen identification*

Analytic performance indicators

  • Proficiency testing
  • Test reliability
  • Turnaround (analytic) times
  • Quantity-not-sufficient (QNS) specimens*

Post-analytic performance indicators

  • Revised reports*
  • Total Critical Results Notification reports*

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 patients and customers. 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.

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 and CAP Q-Tracks®. We also participate in a wide variety of proficiency testing to ensure the accuracy of test results. In addition, we participate in external assessments that include, but are not limited to, regulatory inspections and/or accreditation assessments. An internal audit program also monitors operations and the quality system. It is designed to assess the effectiveness of the quality system and assess the adequacy of standard operating procedures. 

Our laboratories participate in interlaboratory proficiency testing which includes the following independent state, national and international programs:

  • American Association of Bioanalysts (AAB)
  • AABB (formerly American Association of Blood Banks)
  • The Binding Site
  • Centers for Disease Control and Prevention (CDC)
  • College of American Pathologists (CAP) Surveys
  • European Molecular Genetics Quality Network (EMON) External Quality Assessment (EQA) Scheme
  • European Research Network of Inherited Disorders of Metabolism (ERNDIM)
  • Heathcontrol (TDM LGC)
  • Le Centre de Toxicologie du Quebec, Quality Assessment Scheme (QMEQAS)
  • Le Centre de Toxicologie du Quebec, Comparison Program (PCI)
  • New York State Department of Health
  • NordiQC
  • Pennsylvania State Department of Health
  • Vitamin D External Quality Assessment Scheme (DEQAS)
  • Wisconsin State Laboratory of Hygiene

Additionally, we conduct alternate assessments of performance 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).