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Lecture Slides

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0% found this document useful (0 votes)
5 views58 pages

Lecture Slides

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wzeng193
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
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QUALITY MANAGEMENT

PLAN, IMPLEMENT, TRACK, IMPROVE

Kelly Doyle PhD, D(ABCC), FAACC


Assistant Professor of Pathology
University of Utah School Of Medicine
Medical Director, Special Chemistry and Endocrinology
ARUP Laboratories
[email protected]
[email protected]
©UNIVERSITY OF UTAH HEALTH
LEARNING OBJECTIVES
This lecture will enable the participant to:

1. List the elements of a quality management plan


2. Describe key stake holders of the planning,
implementation, maintenance, and
improvement stages of total quality
management plans
3. Explain ways to monitor elements of the plan,
key performance indicators, and improvement
initiatives

©UNIVERSITY OF UTAH HEALTH


WHY THIS TOPIC IS IMPORTANT TO ME?

• Two experiences soon out of fellowship:


1. Lead an effort to start a new department in a
large lab network
• How do I fit this new effort into an existing
quality framework?
2. Get a quickly growing lab CAP accredited
• How do I build the quality framework and
make it continuously work?

©UNIVERSITY OF UTAH HEALTH


OUTLINE

I. History of Quality Management – PDSA model


II. Quality Management Fundamentals
III. Responsibilities of Lab Directors and Pathologists
IV. Elements of a Quality Management Plan
V. Making the Quality Management Plan Operational
VI. Tools, Metrics, and Outcomes
VII. Risk Assessment Across the Process
VIII. Resources

©UNIVERSITY OF UTAH HEALTH


HISTORY OF QUALITY MANAGEMENT

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

STUDY Basic Quality Management Systems, Westgard, JO et al. 2014


©UNIVERSITY OF UTAH HEALTH
QUALITY
MANAGEMENT
FUNDAMENTALS

pixabay.com/users/272447-272447
https://www.moabadventurecenter.com/desolation-canyon-rafting/map
©UNIVERSITY OF UTAH HEALTH
KEY QUALITY MANAGEMENT ELEMENTS

• Statement affirming commitment to quality


and patient safety
• Risk assessment
• Monitoring and control activities
– Identify indicators and metrics
• Response to identified problems
• Information and communication
• Continuous improvement

CAP Presentation by Paul Bachner, MD, FCAP

©UNIVERSITY OF UTAH HEALTH


KEY QUALITY MANAGEMENT COMPONENTS

• Written Quality Plan (CAP & CLIA)


– High emphasis by CAP (critical deficiency)
• Annual review & approval by director
– 2.2% of CAP labs had not performed!
• Specify information/reporting method
• Accuracy of results (analytic)
• Integrity of pre & post-analytic processes in
all sections

CAP Presentation by Paul Bachner, MD, FCAP

©UNIVERSITY OF UTAH HEALTH


QUALITY MANAGEMENT PLAN FORMATS

• Format may be Laboratory designed


• CLSI (NCCLS) guidelines (GP-22 or GP-26)
• ISO 9000 series
• ISO 15189 accreditation and standards
• JC model for improvement of organizational
performance
• AABB quality program
• Safety plan integrated or separate

CAP Presentation by Paul Bachner, MD, FCAP

©UNIVERSITY OF UTAH HEALTH


WHAT WILL INSPECTORS BE LOOKING FOR?

• 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:

It is the responsibility of the lab director to


“…ensure that the laboratory develops and
uses a quality system approach to laboratory
testing that provides accurate and reliable
patient test results.”

CLIA Brochure - Laboratory Director Responsibilities


CMS.gov
©UNIVERSITY OF UTAH HEALTH
RESPONSIBILITIES OF LAB DIRECTORS AND
PATHOLOGISTS

CAP Accreditation:

“Director must assume responsibility for


implementation of the quality management
plan. The director and professional laboratory
personnel must participate as members of the
various quality management committees of the
institution.”

www.CAP.org

©UNIVERSITY OF UTAH HEALTH


RESPONSIBILITIES OF LAB DIRECTORS AND
PATHOLOGISTS

CAP Accreditation:

“Ensure that the laboratory participates in the


monitoring and evaluation of the quality and
appropriateness of services rendered within the
context of the quality assurance program
appropriate for the institution, regardless of
testing site(s).

www.CAP.org

©UNIVERSITY OF UTAH HEALTH


ELEMENTS OF A QUALITY MANAGEMENT PLAN
(QMP) -RESOURCES

©UNIVERSITY OF UTAH HEALTH


QUALITY MANAGEMENT PLAN

Why is the QM Plan important?


– CAP and CLIA accreditation requirement
– Will improve patient care and safety
– Will help you to improve lab services (money, time)
– Ensures continuing surveillance and management
– Always ready for inspection
What are the key compliance issues?
– Plan format
– Components (entire analytic cycle, all sections)
– Metrics, benchmarks, and indicators
– Corrective action and follow-up to problems
– A focus on how the plan contributes to patient safety
Laboratory Administration for Pathologists, CAP, 2011
CAP Presentation by Paul Bachner, MD, FCAP
©UNIVERSITY OF UTAH HEALTH
TEMPLATE FOR QM PLAN - 12 QUALITY SYSTEM
ESSENTIALS
1. Organization
2. Personnel Resources
3. Equipment
4. Supplier, Customer Issues, and Referral Laboratories
5. Process and Performance Control (QC, PT)
6. Documents and Records
7. Occurrence Management
8. Assessments and Audits
9. Process & Performance Improvement
10. Facilities and Safety
11. Information Management
12. Customer Service and Satisfaction
Laboratory Administration for Pathologists, CAP, 2011
CAP Presentation by Paul Bachner, MD, FCAP
©UNIVERSITY OF UTAH HEALTH
12 QUALITY SYSTEM ESSENTIALS

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

Laboratory Administration for Pathologists, CAP, 2011


CAP Presentation by Paul Bachner, MD, FCAP
©UNIVERSITY OF UTAH HEALTH
12 QUALITY SYSTEM ESSENTIALS

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

4. Supplier, Customer Issues, and Referral


Laboratories

Supplies
• Who is responsible for supporting lab
operations?
– Uninterrupted flow of supplies and services?
– Quantity, quality, right time, price
– Procedure for supply recall

Laboratory Administration for Pathologists, CAP, 2011


CAP Presentation by Paul Bachner, MD, FCAP
©UNIVERSITY OF UTAH HEALTH
12 QUALITY SYSTEM ESSENTIALS
4. Supplier, Customer Issues, and Referral
Laboratories

Customer Issues (Surveys)


• Clinicians and nurses
– TAT, critical values, phlebotomy response, test menus,
consultation, courtesy
• Employee satisfaction
– Communication, work environment and facilities, pay
& promotion, “morale”
• Patients
– phlebotomy, wait times, courtesy, complaints
Laboratory Administration for Pathologists, CAP, 2011
CAP Presentation by Paul Bachner, MD, FCAP
©UNIVERSITY OF UTAH HEALTH
12 QUALITY SYSTEM ESSENTIALS

4. Supplier, Customer Issues, and Referral


Laboratories

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

5. Process and Performance Control (QC, PT)

Quality Control (QC)


• Analysis of materials of known composition or
reactivity in conjunction with patient samples
• Measure of precision and confirms instrument
calibration
– QC frequency (min. vendor or CAP)
– Process for QC drift, shifts, outliers
– QC record retention policy (hard copy and
digital)
Laboratory Administration for Pathologists, CAP, 2011
CAP Presentation by Paul Bachner, MD, FCAP
©UNIVERSITY OF UTAH HEALTH
12 QUALITY SYSTEM ESSENTIALS

5. Process and Performance Control (QC, PT)

Proficiency Testing (PT)


• Periodic testing of blinded samples
– sent to the lab by an approved agency
– If not available, alternate performance
assessment (APA) must be defined and followed
semi-annually
• No inter-lab sharing/communication
• Integration into routine workflow
• Process to address failures and near misses
Laboratory Administration for Pathologists, CAP, 2011
CAP Presentation by Paul Bachner, MD, FCAP
©UNIVERSITY OF UTAH HEALTH
12 QUALITY SYSTEM ESSENTIALS

5. Process and Performance Control (QC, PT)

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

6. Documents and Records


• Management policy for documents
– Policies, procedures, QC records, PT records, etc
– Appropriateness (up to date)
• May use master lists and SOPs for document
management
• Who is responsible for management, review,
signatures
• Document retention and discard
• Helpful to list as a table
Laboratory Administration for Pathologists, CAP, 2011
CAP Presentation by Paul Bachner, MD, FCAP
©UNIVERSITY OF UTAH HEALTH
HANG IN THERE

www.savagechickens.com

©UNIVERSITY OF UTAH HEALTH


12 QUALITY SYSTEM ESSENTIALS

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

• CAP Patient Safety Goals


– Improve patient & sample identification
– Improve verification and communication of life-
threatening information (critical values, tests)
– Improve identification, communication and
correction of errors
– Improve integration & coordination of the
laboratory patient safety role within the
healthcare organization
– Utilize data within system to improve care
CAP Patient Safety & Performance Measures Committee
CAP Presentation by Paul Bachner, MD, FCAP
©UNIVERSITY OF UTAH HEALTH
12 QUALITY SYSTEM ESSENTIALS

8. Assessments and Audits


• List expected external assessments
– CAP, CMS, FDA, AABB, CDC, state agencies,
Joint Commission
• Describe internal
– CAP interim, personnel competency
assessments, quality indicators, periodic audit of
QM plan, safety audits
• Can refer to individual SOPs to keep this
section simple
Laboratory Administration for Pathologists, CAP, 2011
CAP Presentation by Paul Bachner, MD, FCAP
©UNIVERSITY OF UTAH HEALTH
12 QUALITY SYSTEM ESSENTIALS

9. Process and Performance Improvement


• Define the authority, responsibility, and
delegation
– Lab director and quality management team
• Define basis for review (including
establishment of a quality committee), and
organizing an improvement project (e.g.,
FOCUS-PDCA)
• Involve all lab sections, pre-analytic,
analytic, and post-analytic processes
Laboratory Administration for Pathologists, CAP, 2011
CAP Presentation by Paul Bachner, MD, FCAP
©UNIVERSITY OF UTAH HEALTH
12 QUALITY SYSTEM ESSENTIALS

9. Process and Performance Improvement (cont.)


• List hospital/clinic or other committees
– Infection control
– Transfusion
– Safety
– Quality Committee(s)
Interdisciplinary involvement critical to
improvement and to demonstrate lab integration
with institutional QM programs

Laboratory Administration for Pathologists, CAP, 2011


CAP Presentation by Paul Bachner, MD, FCAP
©UNIVERSITY OF UTAH HEALTH
12 QUALITY SYSTEM ESSENTIALS
9. (continued) How to do it
• FOCUS
– Find a process to improve
– Organize a team
– Clarify current knowledge
– Understand variation
– Select process to improve
• PDCA/PDSA
– Plan the improvement action
– Do/test the action
– Check to determine the effects of the action
– Act to implement or change approachLaboratory Administration for Pathologists, CAP, 2011
CAP Presentation by Paul Bachner, MD, FCAP
©UNIVERSITY OF UTAH HEALTH
12 QUALITY SYSTEM ESSENTIALS

9. (continued) Sample QM Indicators


• Diabetes monitoring (system)
• Hyperlipidemia screening (system)
• Test order accuracy (preanalytic)
• Patient identification (preanalytic)
• Blood culture contamination (preanalytic)
• Adequacy of specimen information
(system/preanalytic)

Laboratory Administration for Pathologists, CAP, 2011


CAP Presentation by Paul Bachner, MD, FCAP
The Institute for Quality in Laboratory Management; CAP TODAY, June 2005

©UNIVERSITY OF UTAH HEALTH


12 QUALITY SYSTEM ESSENTIALS

9. (continued) Sample QM Indicators


• Accuracy of point-of-care testing (analytic)
• Cervical cytology/biopsy correlation
(analytic)
• Critical value reporting (postanalytic)
• Turnaround time (postanalytic)
• Clinician satisfaction (system & postanalytic)
• Clinician follow-up (system & postanalytic)

Laboratory Administration for Pathologists, CAP, 2011


CAP Presentation by Paul Bachner, MD, FCAP
The Institute for Quality in Laboratory Management; CAP TODAY, June 2005

©UNIVERSITY OF UTAH HEALTH


12 QUALITY SYSTEM ESSENTIALS – SAMPLE QM
INDICATORS

Shahangian, S. Snyder SR. AJCP, 2009, 131(3), 418–431

©UNIVERSITY OF UTAH HEALTH


12 QUALITY SYSTEM ESSENTIALS

10. Facilities and Safety


• Describe participation in facilities and
safety
• Refer to the safety manual (usually large)
• Annual safety audit of lab sections
• Lab safety committee manages safety and
facilities initiatives

Laboratory Administration for Pathologists, CAP, 2011


CAP Presentation by Paul Bachner, MD, FCAP
©UNIVERSITY OF UTAH HEALTH
12 QUALITY SYSTEM ESSENTIALS

11. Information Management


• Authority to approve users and access
• States that policies and procedures exist for
data security and transfer integrity
• List security measures (passwords, security
levels, access)
• Document audit of data transfer
• HIPPAA compliance is described
• Frequency of system checks
• Annual report of system integrity
Laboratory Administration for Pathologists, CAP, 2011
CAP Presentation by Paul Bachner, MD, FCAP
©UNIVERSITY OF UTAH HEALTH
12 QUALITY SYSTEM ESSENTIALS

12. Customer Service and Satisfaction


• State frequency of surveys
• Physicians and nurses
– TAT, critical values, phlebotomy, test menus,
consultation, courtesy
• Employee satisfaction
– Communication, work environment, pay &
promotion, “morale”
• Patients
– phlebotomy, wait times, courtesy, complaints
Laboratory Administration for Pathologists, CAP, 2011
CAP Presentation by Paul Bachner, MD, FCAP
©UNIVERSITY OF UTAH HEALTH
MAKING THE QUALITY
MANAGEMENT PLAN
OPERATIONAL

Photo by Tom Fisk from Pexels


©UNIVERSITY OF UTAH HEALTH
FUNDAMENTALS OF QUALITY MANAGEMENT
IMPLEMENTATION

• Implement as designed in the QM plan


• Explicit delegation of responsibility
• Specify frequency of activities
• Create quality committee(s)
• Evidence and documentation
– Committee minutes
– QI reports
– Documents responding to complaints,
problems, adverse events
Laboratory Administration for Pathologists, CAP, 2011
CAP Presentation by Paul Bachner, MD, FCAP
©UNIVERSITY OF UTAH HEALTH
MAKING THE QUALITY MANAGEMENT PLAN
OPERATIONAL

Compliance

Education Safety

Quality

©UNIVERSITY OF UTAH HEALTH


MAKING THE QUALITY MANAGEMENT PLAN
OPERATIONAL

Laboratory
Director

Quality and
Regulatory
Affairs Manger

Compliance Education Quality Safety


Officer Officer Officer Officer

©UNIVERSITY OF UTAH HEALTH


TOOLS, METRICS, OUTCOMES

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”

©UNIVERSITY OF UTAH HEALTH


SHORT TERM/REAL-TIME MONITORING –
MOVING AVERAGES/MEDIANS

Example of monitoring medians at Intermountain Healthcare using Data Innovations software

©UNIVERSITY OF UTAH HEALTH


EXAMPLE MONTHLY QC REVIEW – PEER BASED

Instrument(s) evaluated: C1 AND I1


Month in Review: Mar-19 Lab Peer Set Lab Peer Lab Lab Peer Lab Set Lab Peer Lab Peer Lab
TEST METHOD LOT# Count Count Mean Mean Mean z-score CV CV CVR S.D SD SD SDI Set SD SD MoM Comments
ACETDA I1 40951 64 626 9.5 9.6 9.6 -0.19 6% 5% 1.2 1 0.6 0.49 -0.02 1.0 1.0
ACETDA I1 40952 64 603 37 37.1 37.3 -0.21 2% 2% 1.1 1 0.7 0.62 -0.22 1.0 1.0
ACETDA I1 40953 64 640 107 106.8 107.5 0.14 1% 2% 0.8 3 1.3 1.65 -0.44 3.0 1.0
ALB C1 47951 67 1309 2.6 2.6 2.6 -0.58 2% 2% 1.3 0.1 0.1 0.04 0.41 0.1 1.0
ALB I1 47951 33 1309 2.6 2.6 2.6 -0.42 1% 2% 0.9 0.1 0.0 0.04 0.06 0.1 1.0
ALB C1 47953 65 1303 4.6 4.6 4.6 0.42 1% 1% 1.2 0.1 0.1 0.05 0.36 0.1 1.0
ALB I1 47953 33 1303 4.6 4.6 4.6 0.23 1% 1% 1.1 0.1 0.1 0.05 0.61 0.1 1.0
ALB C1 56611 10 37 2.6 2.6 2.7 0.82 2% 20% 0.1 0.1 0.0 0.54 -0.27 0.1 1.0
ALB I1 56611 11 37 2.6 2.5 2.7 1.63 2% 20% 0.1 0.1 0.0 0.54 -0.33 0.1 1.0
ALB C1 56613 10 29 4.6 4.6 4.6 0.47 1% 1% 1.2 0.1 0.1 0.05 -0.01 0.1 1.0
ALB I1 56613 11 29 4.6 4.6 4.6 0.44 1% 1% 1.2 0.1 0.1 0.05 0.04 0.1 1.0
ALC C1 54261 33 263 40 41.0 60.1 -0.74 3% 96% 0.0 2 1.3 57.9 -0.33 2.0 1.0
ALC I1 54263 32 162 247 246.1 251.8 0.14 3% 2% 1.0 8 6.2 6.18 -0.92 7.0 1.1
ALKP C1 47951 65 1320 31.5 32.5 29.7 -0.63 5% 6% 0.8 2.5 1.6 1.77 1.61 2.5 1.0
ALKP IC 47951 37 1320 32 31.5 29.7 0.36 5% 6% 0.8 2.5 1.4 1.77 1.02 2.5 1.0
ALKP C1 47953 64 1316 325 324.3 318.5 0.12 2% 2% 1.0 9 5.8 5.92 0.99 8.0 1.1
ALKP I1 47953 37 1316 328 325.7 318.5 0.43 2% 2% 0.9 9 5.3 5.92 1.23 8.0 1.1
ALKP C1 56611 10 37 32 31.4 55.5 0.17 12% 136% 0.1 2.5 3.6 75.4 -0.32 2.5 1.0
ALKP I1 56611 11 37 32 31.3 55.5 0.20 12% 136% 0.1 2.5 3.7 75.4 -0.32 2.5 1.0
ALKP C1 56613 10 29 304 304.0 307.0 0.00 2% 2% 1.3 9 6.8 5.32 -0.57 9.0 1.0
ALKP I1 56613 11 29 304 309.2 307.0 -1.08 2% 2% 0.9 9 4.8 5.32 0.40 9.0 1.0

©UNIVERSITY OF UTAH HEALTH


EXAMPLE MONTHLY QC REVIEW – PEER BASED

• Other sources of peer-based QC


monitoring

BioRad Unity. www.QCNET.com

©UNIVERSITY OF UTAH HEALTH


EXAMPLE – WEEKLY NONCONFORMANCE REPORT

ARUP Laboratories

©UNIVERSITY OF UTAH HEALTH


PROCESS-BASED RISK ASSESSMENT

College of American Pathologists, 2016


©UNIVERSITY OF UTAH HEALTH
PROCESS-BASED RISK ASSESSMENT

Preanalytic
Stage Item Risk Mitigation Plan Tracking/Log
Description
A
B
C
Analytic
A
B
C
Postanalytical
A
B
C

©UNIVERSITY OF UTAH HEALTH


RESOURCES

• 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

Wagar, Horowitz &


Siegal's Laboratory
Administration for
Pathologists
Elizabeth A. Wagar, MD, Michael B. Cohen,
MD, Donald S. Karcher, MD, and Gene P.
Siegal, MD, PhD

©UNIVERSITY OF UTAH HEALTH


SUMMARY

Do your people
know what they are
doing?

Does your process


produce quality
results?

Thank you!

Kelly Doyle
Utah Strong Flyover 4.30.2020
©UNIVERSITY OF UTAH HEALTH

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