Use of Quality Tools in the Medical Laboratory Manuel Tamez, MT(ASCP)M CQPA(ASQ) September 12, 2017 Thank you Robert. Good evening everyone. I have something to add to my bio. I joined ASQ this past January. Like all of us, I wanted to become a member of a professional society in my chosen field. About a month later, I received an email invite from Ben to attend a local ASQ chapter meeting! I’ve been coming ever since. About 2 months or two meetings later, Robert approached me to ask if I’d consider speaking at a future meeting. And I said YES! I later asked Gloria to give me a sense of who my audience would be. I was beginning to recognize our members, but didn’t know much about them. She said that our members are quality leaders in our community. What could I possibly talk about? Tonight I’ll share examples how the quality tools we all use are applied in a medical laboratory.

Objectives To see how quality in a medical laboratory compares to quality in your discipline. To provide assurance that the laboratory of your choosing is highly capable to take care of your testing needs. The objectives are to see what comparisons can be made regarding how we approach quality. It’s also my hope to assure you that the laboratory of your choosing is highly capable to take care of your testing needs.

Quality Defined Quality, according to Joseph Juran, means that a product meets customer needs leading to customer satisfaction… http://study.com/academy/lesson/joseph-jurans-theory-definition-of-quality.html Quality defined. We can define Quality any number of ways, as it relates to us. But, no one will argue with Joseph Juran’s definition: Quality means that a product meets customer needs leading to customer satisfaction, and quality also means all of the activities in which a business engages in, to ensure that the product meets customer needs.

Measuring Quality in the Outpatient Laboratory Customer Satisfaction Surveys ASQ states that cost of quality is a methodology that, in part, appraises the quality of the organizations products or services.

12% return rate on average 12% return rate on average. Studies show the overall response rate is 10-15%. Our average score could be 88% which could translate to a percentile of 76% when measured against other like laboratories.

Cost of Poor Quality A perception to a customer of lack of quality in a laboratory can be due to: Delays Rework Effect on People Costs of LACK of Quality Most apparent: Delays - longer that usual time to result a test. If due to repeating if performance cannot be validated by internal or external controls. Rework costs – staff time, supply costs Budgetary costs – financially can be difficult to drill down to for some tests. Some rework comes with the business. Repeating tests when values are outside of an expected range. PEOPLE – A cost of quality story…….

An Opportunity Story – Missed Lab Tests

The quality tools that could have been used.

Five Whys Why did this occur? Too many tests ordered that I couldn’t find. Why? They weren’t listed in the lab computer. They were uncommon tests. MD used different terminology and office was closed. MD was from out of state.

All Labs are Capable, then what makes a difference? The same thing that differentiates your company from competitors. A robust Quality Management System. And a strong, unfailing commitment to all customers. A quality management system (QMS) is a collection of business processes focused on consistently meeting customer requirements and enhancing their satisfaction. All aspects of the laboratory operation need to be addressed to assure quality; this constitutes a quality management system.

Quality Management System The same thing that differentiates any organization from competitors. It defines the operating structure for continuous quality improvement.

CLSI GP26-A4 2011 CLSI QMS Model for Laboratories Clinical and Laboratory Standards Institute provides guidelines for laboratories to establish their quality programs. Quality System Essentials Quality System Essentials originate from regulatory, accreditation and standards requirements for laboratories. Encompasses essential information that maps out plans and responsibilities associated with each QSE. QM Plan CLSI GP26-A4 2011 CLSI QMS Model for Laboratories

CLSI GP26-A4 2011

…and quality also means all of the activities in which a business engages in, to ensure that the product meets customer needs. http://study.com/academy/lesson/joseph-jurans-theory-definition-of-quality.html Extending Joseph Juran’s definition, quality also means all of the activities in which a business engages in, to ensure that the products meets customer needs. In the laboratory, that means every step of the way. From pre-analytical testing when the test order originates and gets collected, analytical phase when the testing is performed, to the post-analytical phase when the result is obtained, verified and reviewed, reported and available for a providers interpretation and action.

Laboratory Regulations CLIA – passed in 1988 to establish quality standards for all non-research laboratories. CMS – approves accreditation organizations that perform inspections FDA CDC What do they share in common? Regulations. What gets a laboratory to a higher level of quality? Regulations, peer standardization. CLIA mandates that virtually all laboratories have a CLIA certificate to operate. If they perform lab testing on human specimens for diagnosis or treatment it’s required.

Laboratory Accreditation CAP College of American Pathologists AABB American Association of Blood Banks ASHI American Society for Histocompatibility and Immunogenetics TJC The Joint Commission

ISO 15189 and CAP Cap.org

Quality Boards Associate Communication Boards Performance Boards Quality Boards Gemba Boards

Operational Pillars Ref: Hardwiring Excellence – Quint Studer

Community Quality People   Growth Finance

QUALITY FINANCE PEOPLE GROWTH COMMUNITY patients are satisfied with shorter time in the ED. More giving toward charity care.. recognize and reward associate improvement efforts reduces turnover rate meeting goals increases physician satisfaction and more referrals are made outside of goal metric could contribute to longer hospital stays and higher total charges. monitor the metric.

Performance Board

Gemba Board

Quality Board Challenges Involve the Team Quality Board Challenges Keep the board current. Keep it simple or educate the team. No small print. Relate the metric to how they can make an impact. Refer back to the board Re-educate Consider their time Repeated exposure Huddles by the board. Get feedback. Form teams.

Lean Transformation Five S A 100 day project

Leadership Involvement

Workstation – before and after a Five S.

An Audit love story Audits - one of the most used tools by the Quality department of any organization to check the effectiveness of processes put into place. Audits help discover opportunities that need addressed to keep staff safe and to lean out unnecessary waste. Key to auditing is to develop a trust bond with the people in the Gemba (where the work occurs).

Challenges Standardization of process – Eliminating variation Recognition of laboratory services Variation in training Maintaining documentation current

References ASQ (http://asq.org/learn-about-quality/quality-tools.html) CMS.gov CLIA and Medicare Laboratory Services Hardwiring Excellence by Quint Studer http://www.executivewarcollege.com/wp-content/uploads/2012/04/Serrano-Why-ISO-15189-Change-Laboratory-Operations.pdf GP26-A4 Same Quality Systems Essentials, Different Perspectives Lab Medicine, Volume 43, Number 1, January 2012 Press Ganey.com