Revised Quality Management Basics Texas Histology Society

Quality Management Basics

The Histology Laboratory

My introduction

• Joelle Weaver MAOM, HTL (ASCP)• Undergrad-BGSU, Masters- Bluffton University, also HTL –ASCP

• My “pet topics” - team approaches to quality and organizational effectiveness, organizational culture, building teams.

• This topic came to me from seeing posts where there was confusion about the terms QA, QC, and quality systems, and my own experiences with process improvement initiatives…

• To me its a question of “how wide you throw the net” in thinking about QC, QA, QMS- the terms each describe a part of the whole to create the environment for excellent quality, good patient care …

Content Description

• Outline of basic principles of quality management• Discuss terminology ( define QC, QA, and QMS). • Identify the phases of any lab processes and relate these

to quality considerations.• Some added ideas for approaching quality management

using a team process improvement approach.• Structure that supports a “quality culture”.• Implementation ideas for new quality control systems

and/ or evaluation of existing methods.• Identification of external and internal measurement

sources for quality assessment.

Learning Objectives• Acknowledge historical context and existing challenges within

histology

• Clarify terminology associated with quality management

• Outline components of an effective quality management system

• Provide quality management examples for system improvements supporting quality

• Identify errors that impact quality and identify tools to identify and manage errors.

• Relate the above concepts to occurrence management, internal/external assessment and process improvement.

• Discuss practices and organizational attributes which support a “quality culture”.

HISTORICAL PROGRESSIONQuality management in Histology

Acknowledge historical context and existing challenges within histology

• Historically, histology less intervening technology, mostly “labor intensive, manual” process for over 100 years.

• Due to the slower adoption of technology/automation, histology has lagged behind the QA, PI- seen in clinical lab, other medical arenas.

• ?Reasons; tradition, staff shortages, manual steps difficult to automate and standardize.

Finding Resources/Time for Quality

• Necessity-CAP requires a written quality improvement plan ( checklist item ANP.1000).

• Most effective, when direct, as simple as possible, and tied to organization’s mission in a clear way.

• Ideally QC,QA and quality improvement activities –become everyone’s responsibility-not just MGMT.

TERMINOLOGYKey terminology used when discussing quality management

Key terms associated with quality management

• 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) .

BASIC COMPONENTS A more detailed look at QC, QA, Quality Management

Quality Control- QC

• 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.

• Example sheet in handout.

Quality assessment-QA

• QA checks the effectiveness of the QC practices used, and is used to determine if an analytical process in compliance with QA guidelines.

• This is achieved through systematic identification, measurement and documentation of quality variables.

Clarifying Goals of QA/QC

Important points

• Quality assurance is not quality improvement.

• 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 considerQuality Assurance

Quality Improvement

Motivation Measure compliance with standards

Continuous process to meet standards

Means Inspection Prevention

Focus Individuals Processes and systems

Responsibility few ALL

Elements of the “Quality Assurance Plan “

Organizational elements to be outlined (sample included in handout)

• Mission statement

• Overall quality objectives

• Organizational chart

• Code of ethics

• Training, safety practices

• Procedures

• Competency, assessment

Outline components of an effective quality management system( QMS)

• Quality measure essentials- need QA and QC

• Necessary to assure/promote confidence in analytical results ( support org. goals).

• Comprised of those activities to monitor and document effectiveness of the QC practices ( accuracy & precision).

• Formal documentation useful to set guidelines for all methods within lab operation.

QUALITY MGMT & IMPROVEMENT

How to assess where the quality problems are…

The process cycle 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.

Problem feedback loop

• Basic important element to dealing with errors and quality- a feedback loop.

• A method that shows what errors are detected ( when in the process) , how they are resolved ( action or correction), then document patient impact.

• This loop reinforces/communicates the relationship to how well we do, and what we do at each step, to its impact on the patient.

• Example worksheet to collect technical error feedback in included in the handout.

HOW TO IDENTIFY ERRORS TO PRODUCING QUALITY

Quality Improvement Opportunities

General Principles-error reduction-systems in QI

• System solutions-related to the structure and function of work processes

• Goal 1- reduce options, complexity/variation, decrease reliance on vigilance ( checklists, automation, work logs etc.)

• A system with internal checks, use of technology, helps address human intervention, and process complexity problems

• Goal 2-Standardization( reduces guesswork, creates consistency, making training simplified)

• Goal 3- Streamline information movement

General Principles-error reduction-people

• Personnel solutions- having the right people, with the right information/resources to do the task at the right time.

• Schedules

• Environment

• Training

• QI addresses fixing problems not people, but people are essential to success of any process.

Defining-Identifying system/process weak spots

• Error types- how are they defined?

• Classically defined in original taxonomy( Eiden-Hoven Model for RCA) a commonly applied methodology to identify latent problems

• Categories:

• Technical failure ( equipment & software)

• Organizational error ( policies, procedures, protocols)

• Human errors ( mistakes and violations)

• See handout for more information/examples.

Identifying specific problems

• Analysis of the error or problem can be approached in two ways:

• One method is analysis of collected data, good if the team goal is mainly to improve effectiveness ( referred to as data analysis).

• The alternate method is analyzing the process itself through process maps, good if the team goal is to improve efficiency ( referred to as process analysis).

• You can use tools to see if system/personnel corrections will apply

• * See hand out for a list of alternate analysis tools-we will discuss RCA in a little more detail….

Root cause analysis

Pitfalls in RCA applications

• Root Cause analysis falters when it stops with data collection- you need to use this tool to analyze the “whys”.

• Failing this step, the results are often conclusions that are incomplete, and corrections that are faulty or lacking in follow-up.

• RCA should be considered a criteria framework for improvement opportunities, its best use is to specifically define error sources for process improvements.

Example fishbone –another tool that helps with- What/where are the errors?

IMPLEMENTATION AND DOCUMENTATION

Construction of a plan

Implementation ideas for new quality control systems and/ or evaluation of existing methods

I am a fan of the team approach- a logical way for mgmt to implement using the project team input is:

• Identify a possible root cause(s) for a specific error (suggest using RCA).

• List all the possible factors of the problem ( fishbone good for this).

• Segment/stratify ( give subjective weight to) the identified factors ( FMEA can be used).

• Prioritize by selecting what the team feels are the vital few ( those with the most impact on errors to target 1st, and support with data).

• Implement correction, then verify and quantify the impact of the change on the root cause of the process variation ( error) in QA tracking.

• Report and communicate in a concise way, that presents back to the team what was done, and the results or improvements.

• Revise/refine using feedback and data until the target goal is met.

• Note this is a continuous process- on-going.

Ideas for MGMT- Establishing control limits-Descriptive Statistics and Control Charts

• Descriptive statistics quantify the QA program- can put ↑information for easier analysis/comparison

• Together accuracy and precision document the systematic and random errors which make up the analytical uncertainty in lab results, error sources.

• Accuracy & precision stats are the quantified base for performance criteria if a methodology is in “statistical control”, and whether goals are being met and maintained over time.

• People are often under the impression they give excellent care, defensiveness, resistance result- facts bolster ways to do better.

External/Internal Assessment

• The laboratory cannot improve the quality of its service without measuring its current performance.

• The data that you have collected and used to both quantify and qualify different quality measures can then be compared to both internal and external quality measures and/or your quality goals.

• The lab should participate in 3 types of external assessments- 1. licensing and accreditation, 2. proficiency testing, and 3. performance comparison.

• The results of these comparisons can help in determining if a problem really exists, has been improved, or needs continued monitoring or changes.

Sources for assessing your quality performance

Any Comparisons made should:

2. Utilize accredited laboratories

3. Be made to validated methods

4. Include any estimation or measurement of uncertainty

A QUALITY CULTURE

Quality starts at the “top”

“Big 7”

3.Lack of management commitment4.Inability to establish a quality culture5.Lack of employee buy-in6.Non-supportive measurement systems7.Lack of quality training8.Underinvestment in the quality initiative9.Poorly communicated and unrealistic expectations resulting from a lack of organizational alignment

Why hasn’t this already solved the problem?

• Change the culture first (conventional thinking);

• Suggest it is better to change the systems first ( using tools), then the culture will more likely follow…

“ It is easier to act your way to a new way of thinking, than to think your way to a new way of acting…”

Quality/Process Improvement Barriers

• 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”.

References consulted

• I have included a reference list for the materials that I have consulted at the end of the handout sheet.

Questions or comments?

• 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.

• We can now take any questions or comments…