Quality control- ( technical- identifies inaccurate in the process/system, verifies proper use by testing personnel) .
Quality assurance- ( management- outlines QC activities, identifies processes/procedures that are not working, provides corrective process steps).
Quality improvement- ( verifies proper QA and QC, assesses methodologies based on metrics, sets goals and parameters for improvement) .
Non-conformity- a process failure, error or undesired outcome from a process or process step.
Process- a series of defined steps in an outcome directed activity that leads to an intermediary product, final product, information output or result. ( note that any process can be broken down into sub-process steps or expanded out to relate to other ongoing processes) .
Includes documentation, training, and implementation of desired practices and procedures.
A complete listing of standard operating procedures or ( SOP’s) are one of the most important practices- helps insure consistency and minimizes variability.
Suggest: develop a written summary of known error sources identified from doing procedures in the lab from QC/QA records- useful for troubleshooting, new employees and the promotion of continuity over a succession of testing personnel and operations over time with any individual technician/technologist.
It is not adequate for management to merely attempt QC.
Leadership must guide others to quality as the end result.
How are goals of quality improvement different?
Key differences to consider
Quality Assurance Quality Improvement Motivation Measure compliance with standards Continuous process to meet standards Means Inspection Prevention Focus Individuals Processes and systems Responsibility few ALL
All laboratories have a defined test cycle that is composed of pre-analytic, analytic and post-analytic process phases. The separation of the total process into segments, and this separation assists in more narrowly defining and isolating problems.
Usually system and culture status quo are the biggest barriers…( and we will get into this briefly coming up)
But you can begin with work-engineering-poor workspace design, outdated instrumentation, LIS not effective (poor information flow)
Use process analysis to improve processes that lack cohesive flow between steps, redundant steps, insufficient detail in procedures, variables affecting outcomes not given consideration in procedure (correction process).
You cannot change within existing systems This diagram depicts some organizational systems
3 questions asked in the basic improvement model
Provide quality “ actions” for a “culture” that drives quality
Management needs to set quality based standards and metrics that:
Are observable, objective and/or measurable( define quality/quantity/accountability)
The standard must address performance over which the employee has control!
There should be clear definitions as to what is acceptable/unacceptable quality or performance ( use QA feedback/correlation), specific examples.
So called “mistakes” can also be viewed as “learning opportunities”. Where ( at what point) was the wrong judgment applied?, what can be changed to do better next time? Was the correct change available/defined( ask yourself as a manager) before you blame!
Summary- Bringing actions, change and documentation together
Newly identified process changes aimed at correcting existing process or QUALITY problems must get included in revisions of protocols/procedures/processes to reinforce changed expectations.
Be sure to compile an overall tack and trend of where you have been, where you are headed for PI project targets- this will create the foundation for further changes.
The first improvement project or quality issue you tackle, is usually the most difficult to conceive, implement and sustain . Do not expect clear defined improvements immediately, there will be “fits and starts”.
The problem-feedback-correction loop , important to reinforce/communicate the relationship to how well we do, and what we do at each step, to its impact on the patient.
Essential- Leaders have to be committed to any goals they set, stay positive during set backs, and prepared to absorb feelings of discouragement people may feel from their natural resistance to change- Be a “change agent”.
Thank you for joining me today for a discussion on the basics of quality management in the histology laboratory.
I want to thank the teleconference Network of Texas and the sponsorship of the University of Texas Health Science Center at San Antonio for providing the opportunity for us to present this information.