Pathology Quality

Pathology Quality System

Pathology Quality Plan

Our understanding of "Quality" in the Department of Pathology at Michigan Medicine may not be exactly what you’re expecting.

We have long used a variety of tools including Lean (or Toyota Production) principles, CAP checklists, and the Quality System Essentials as outlined by the Clinical Laboratory Standards Institute (CLSI) in operational quality assurance and quality improvement activities, with much success.

The Division of Quality and Health Improvement (DQHI) was established in late 2014, partly in support of these and other operational quality activities, providing additional expertise and resources in quality audits, root cause analyses, process improvement, accreditation, patient safety, and other activities. In addition, however, DQHI’s mission and vision include a large number of activities aimed squarely at changing the way pathology is practiced, and transforming the patient experience.

How are we doing this? By reimagining the role of pathology and laboratory medicine in the care of patients and continuously pushing the envelope of what’s possible; by directly involving patients and families in their care, practicing our brand of medicine with patients and families, not simply to and for them; by ensuring that we are the best possible stewards of our patients’ precious time, their unique diagnostic specimens, and the finite resources of the ever-changing healthcare system; by leading these innovations from the pathology platform, with its unique testing expertise and unparalleled understanding of pathophysiology.

To these ends, DQHI has partnered with stakeholders and experts within the Department, around the Michigan Medicine enterprise, in the broader University of Michigan community, and beyond, to undertake a number of important projects that you can learn about on this website.


Additional Resources:

A comprehensive Departmental Quality Plan ensures that the goals, organization, and expectations for operational quality activities are clearly defined and communicated to Departmental faculty and staff. The Quality Plan is also used to ensure accountability and engagement at all levels of the Department for activities and behaviors that drive quality outcomes and patient safety. Using the CLSI ‘s twelve Quality System Essentials as a foundation, the plan is intended to align daily work with Departmental priorities, detect and reduce errors and variability, and identify opportunities for improvement.

Ongoing internal audits ensure compliance with the Quality System Essentials as outlined in the Quality Plan and allow for identification of vulnerabilities and remediation of issues before quality is affected. The audit schedules for CP and AP are available in the tabs above.

The plan is reviewed on an annual basis to evaluate the continued effectiveness of the program elements and updated as necessitated. For the most current quality plan, click here to log into Master Control and search for document "QUAL-POL-0002."

Operational Quality System

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.

 Customer Focus

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.

 Facilities and Safety

QSE Facilities and Safety provides information about the laboratory’s physical environment and the maintenance and safety programs needed to support it.


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.

 Purchasing and Inventory

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.

 Process Management

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.

 Documents and Records

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.

 Information Management

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).

 Nonconforming Event Management

The purpose of an event management program is to capture and analyze nonconforming events (NCEs) to identify systemic problems and gain management’s commitment to removing the cause.


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.

 Continual Improvement

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.

Lean Tools

The Michigan Quality System is based on principles pioneered by Toyota and refined in industry and healthcare institutions all over the world. These principles, collectively, are called lean, and the core aim is to maximize customer value and minimize waste. Lean thinking changes the focus of management from optimizing separate technologies, assets, and vertical departments to optimizing the flow of products and services through entire value streams that flow horizontally across technologies, assets, and departments to customers.

To accomplish the goal of maximizing value and minimizing waste, a number of tools have been developed to help you improve your processes. Some of these tools are below:


A3 Template

An A3 is a structured problem solving tool that helps you walk through the steps of identifying, analyzing, and addressing a quality improvement opportunity. It helps document the problem in a standardized way while guiding the project through the necessary steps to success.


Quick Easy Kaizen

A Quick Easy Kaizen sheet is a simple way to both display and describe the before and after of a Kaizen project. The template gives you space for both pictures and a written description all on one page for easy consumptions by your audience.


Gemba Observations

The Gemba Observations form is a simple way to help organize your thoughts while doing a Gemba walk. It also includes a few suggestions of questions to ask to better understand the process you are observing.


Everyday Lean Idea

The Everyday Lean Idea form is a one-page template to help you lay out your idea for a lean improvement. It helps you describe the current problem, your idea for improving it, your plan to test that idea, and your guess at the impact of the plan. Think of it as a mini-A3 for smaller projects.


Quality Improvement Open Issues Tracking

The Quality Improvement Open Issues Tracking form is a managerial tool to help you keep track of the status of multiple projects in an easy-to-read format. This form can be used electronically, but would also be at home on a dashboard or an Everyday Lean Idea board.


Kaizen Idea

The Kaizen Idea card template is a tool that puts some structure around Kaizen ideas submitted by front line staff. It’s the first step to formalizing the improvement ideas that we have every day while doing our jobs.


Value Stream Map Template

A Value Stream Map is a rigorous tool to help you understand the process you would like to investigate, measure that process, identify opportunities for improvement, and then compare those improvements against the current state. Value Stream Maps are very useful for guiding a quality improvement effort where the some of the causes may be unknown.


Problem Definition Template

A Problem Definition Template helps you compare the current state against the desired future state, and identify the problem as the gap between the two.


Waste Walk Gemba Template

A Waste Walk Gemba Template is tool to help you identify areas of waste you see on a Gemba walk and organize them based on the Toyota Production System’s seven categories of waste.


Fishbone Template

A Fishbone Diagram, also known as a Cause and Effect Diagram or Ishikawa Diagram, is a Root Causes Analysis Tool. It is often used in a group brainstorm session, and helps to bring order to the complexity of the many causes of a singular problem.


Data Collection Plan

A Data Collection Plan helps you think through the process of collecting data to inform the project. It is not a template for collecting data, but rather an aid to guide you through thinking about what data you need and how you will get it.


PDCA Cycle Record

A PDCA cycle record helps you keep track of the changes you have made in a process in an effort to solve a problem or improve quality. Use the PDCA cycle record to track each change made and the outcome that resulted so that you know which change(s) had the most positive impact on the process.


PDCA Cycle Experiment Planning Checklist

A PDCA Cycle Experiment Planning Checklist is a tool to help you begin an experiment, or pilot, in the context of a PDCA project. It helps walk the project team through the steps of sharing the experiment with stakeholders, training the participants, measuring the outcome, and sharing the results.


Risk Template

A Risk Template is a tool to help you anticipate potential risks within a project, estimate their likelihood and severity, and plan countermeasures appropriately.


SIPOC Template

A SIPOC is a scoping tool that is useful when tackling larger value streams or more complex problems. SIPOC diagrams are used to identify all of the relevant elements of a process improvement project before it begins, including the suppliers, inputs, process, outputs, and customers.