Lecture Slides
Lecture Slides
PDSA Model
PLAN
Walter A. Shewhart
(1891-1967)
ACT DO
W. Edwards Deming
(1900-1993)
STUDY
Joseph M. Juran
(1904-2008)
©UNIVERSITY OF UTAH HEALTH
Process model for
PLAN
ISO 15189 QMS
ACT DO
pixabay.com/users/272447-272447
https://www.moabadventurecenter.com/desolation-canyon-rafting/map
©UNIVERSITY OF UTAH HEALTH
KEY QUALITY MANAGEMENT ELEMENTS
• Written QM plan
• Lab director involvement
• Monitoring of process and improvement
• Communication within organization
• Incorporation of PT data & corrective action
• Attention to employee and “client” concerns
• Use of incident reports to improve process
and practice
• All shifts and all sections
Laboratory Administration for Pathologists, CAP, 2011
CAP Presentation by Paul Bachner, MD, FCAP
©UNIVERSITY OF UTAH HEALTH
RESPONSIBILITIES OF LAB DIRECTORS AND
PATHOLOGISTS
“Stereoscopic View”
Kelly Doyle
Clinical Analytical
©UNIVERSITY OF UTAH HEALTH
RESPONSIBILITIES OF LAB DIRECTORS AND
PATHOLOGISTS
CLIA:
CAP Accreditation:
www.CAP.org
CAP Accreditation:
www.CAP.org
1. Organization
• Geographical scope and locations
– one or multiple labs, mobile, POC, etc
• Organization
– Organization charts
• medical and administrative leaders
• managers, supervisors
• updated as needed and reviewed annually
2. Personnel Resources
• List the CLIA personnel and definitions
– Cross-reference chart of local versus CLIA
personnel titles
• Employee orientation, training, annual
competency assessment, CE, safety
training
• Summary of educational resources
• Location and process of documenting
employee assessments and competencies
Laboratory Administration for Pathologists, CAP, 2011
CAP Presentation by Paul Bachner, MD, FCAP
©UNIVERSITY OF UTAH HEALTH
12 QUALITY SYSTEM ESSENTIALS
3. Equipment
• Briefly describe that equipment policies
exist for:
– Selection
– Acquisition
– Installation
– Validation
– Maintenance
– Malfunction response
– Disposal
Laboratory Administration for Pathologists, CAP, 2011
CAP Presentation by Paul Bachner, MD, FCAP
©UNIVERSITY OF UTAH HEALTH
12 QUALITY SYSTEM ESSENTIALS
Supplies
• Who is responsible for supporting lab
operations?
– Uninterrupted flow of supplies and services?
– Quantity, quality, right time, price
– Procedure for supply recall
Referral Laboratories
• Selection is the responsibility of director
– consult with facility and medical staff
• Annual review/audit
– Results
– Service and support
– Contracts
• Compliance with federal requirements
Laboratory Administration for Pathologists, CAP, 2011
CAP Presentation by Paul Bachner, MD, FCAP
©UNIVERSITY OF UTAH HEALTH
12 QUALITY SYSTEM ESSENTIALS
Test validation
• Formal validation of
– Laboratory-developed test (LDT)
– Laboratory-modified test (LMT)
• Minimum requirements:
– Test performance (accuracy, precision, linearity,
carryover, sensitivity, etc.)
– Intended use and applicable specimens
– Clinical validity
– External verification (PT) Laboratory Administration for Pathologists, CAP, 2011
CAP Presentation by Paul Bachner, MD, FCAP
©UNIVERSITY OF UTAH HEALTH
12 QUALITY SYSTEM ESSENTIALS
www.savagechickens.com
7. Occurrence Management
• Systemic analysis of events that affect lab
services, quality, and patient safety
– Serious, common, recurring, or systemic problems
• Capture and analyze nonconforming events
– Random review
– Detection by laboratory or technologist
– External detection (clinicians, nurses, patients, clients)
• Corrective actions
• Root cause analysis for serious or frequent events
• Discussion at quality meetings/committees Laboratory Administration for Pathologists, CAP, 2011
CAP Presentation by Paul Bachner, MD, FCAP
©UNIVERSITY OF UTAH HEALTH
KEEP IN MIND
Compliance
Education Safety
Quality
Laboratory
Director
Quality and
Regulatory
Affairs Manger
Kelly Doyle
©UNIVERSITY OF UTAH HEALTH
TOOLS, METRICS, OUTCOMES
• Statistical control charts
• Process and workflow design charts
• Root cause analysis
– Process mapping, 5 whys, fishbone diagram
• Lean six sigma
• External quality activities
• Quality dashboards
• Spreadsheets
• Risk analysis
• Non-conformance reports
Laboratory Administration for Pathologists, CAP, 2011
CAP Presentation by Paul Bachner, MD, FCAP
©UNIVERSITY OF UTAH HEALTH
SHORT TERM/REAL-TIME MONITORING
• Assay-specific
statistical control
charts
• Device-specific
temperature charts
BioRad Unity. www.QCNET.com
Rees Scientific. www.reesscientific.com
©UNIVERSITY OF UTAH HEALTH
SHORT TERM/REAL-TIME MONITORING –
MOVING AVERAGES/MEDIANS
ED started
calling the lab
- “all my
patients have
high calcium”
ARUP Laboratories
Preanalytic
Stage Item Risk Mitigation Plan Tracking/Log
Description
A
B
C
Analytic
A
B
C
Postanalytical
A
B
C
• Description of CLIA
https://www.cms.gov/Regulations-and-
Guidance/Legislation/CLIA/index?redirect=/clia/
• CLIA Laboratory Requirements
https://www.govinfo.gov/content/pkg/CFR-2003-title42-vol3/xml/CFR-
2003-title42-vol3-part493.xml
• Quality Management in Clinical Laboratories:
Promoting Patient Safety Through Risk Reduction
And Continuous Improvement, P. Valenstein, CAP,
2005
• CAP Laboratory Accreditation Manual:
http://www.cap.org/apps/docs/laboratory_accreditation/standards/lap
manual_0707.pdf
• CLSI Guidelines: GP2-A5, QMS20-R, QMS01-A4
©UNIVERSITY OF UTAH HEALTH
RESOURCES
Do your people
know what they are
doing?
Thank you!
Kelly Doyle
Utah Strong Flyover 4.30.2020
©UNIVERSITY OF UTAH HEALTH