Your Quality Improvement Plan
Gerald A. Hoeltge, MD
Special Commissioner for Complaint
Investigations, PTES Oversight &
Equivalency Determinations
CAP Laboratory Accreditation Program
Objectives
To clarify the checklist differences between
quality improvement and quality control
 To identify aspects of laboratory service pivotal to
patient care
 To help choose those indicators to monitor quality
improvement

6 questions
13 questions
on quality improvement
We will point out
the new questions.
13 questions
on quality improvement
QI is central to accreditation

Standard III
–
–
–
–
Quality Control
Proficiency Testing
Instrument Maintenance
Quality Improvement / Performance Improvement
Most checklist questions are Phase 2
 Featured in the new individual grading report

Grading Summary (partial example)
Distribution of Performance by Peer Group
Personnel and safety
LAB
BGS
STD
EXC
EXC
8.2%
51.0%
40.8%
83.0%
12.6%
Technical processesSTD
4.3%
Quality improvement
EXC
19.1%
0.0%
80.9%
Proficiency testing
STD
7.4%
87.0%
5.6%
LAB = laboratory performance
BGS = below peer group standard
STD = standard
EXC = excellent
Standard III

The Director shall...
– monitor and evaluate quality and appropriateness
– address systematic problems
– participate in institutional QI programs and outcome
studies
– direct efforts to continuing improvement in quality
Checklist questions on quality
INFORMATION MANAGEMENT
LAB INFORMATION SYSTEMS
SPECIMEN MANAGEMENT
REPORTING
INTERPRETATION
TESTING/REVIEW
PROCESSING
SPECIMEN TRANSPORT
SPECIMEN COLLECTION
0
10
20
30
40
after Nevalainen DE, Berte LM. CAP Today, March, 1997
50
60
70
Why have a quality plan?
No different than EOP, safety plan, FVPM
statement
 Its purpose is not to please the inspection team,
but the inspector should use it as a tool to make
the inspection more efficient.

Phase 2
Does the quality improvement program follow
a written plan?
Was it approved by the Director?
 Is it comprehensive?
 Is it structured?

Sahney’s Second Law of Quality
Progress:
Qp = E x
2
M
E = employees’
commitment to
quality
M = management’s
commitment to quality
“Approved by the Director”
Evidence that the director is involved
 Responsibility under Standard I: “Assume

responsibility for implementation of the quality improvement plan.
The director and professional laboratory personnel must participate
as members of the various quality improvement committees of the
institution.”

Quality is still everyone's responsibility! The best
labs are those with a culture of quality.
ISO 9000 series
1. management
responsibility
2. quality system
3. contract review
4. design control
5. document control
6. purchasing
7. purchaser-supplied
product
8. product identification
and traceability
9. process control
10. inspection and testing
11. inspection, measuring
and test equipment
12. inspection and test
status
13. control of nonconforming
product
14. corrective action
15. handling storage, pack
aging and delivery
16. quality records
17. internal quality audits
18. training
19. servicing
20. statistical techniques
ISO DIS 15189






organization and management
quality management system
document control
referral of examinations to
other laboratories
external services and supplies
control of nonconformities






consultative services and
resolution of complaints
preventive actions
corrective actions
quality and technical records
internal audits
management review
ISO/TC 212/WG 1: “Quality Management
in the Medical Laboratory,” Draft
International Standard
NCCLS Guideline GP-22 “Continuous
Quality Improvement”


Team
management
Plans
management

Improvement manage
ment
Selecting an
improvement
process
Systematic
improvement in the
path of workflow
The TQM interface
operating systems
GP26
Q
U
A
L
I
T
Y
S
Y
S
T
E
M
S
1.patient assessment
2.test requests
3.specimen collection
4.specimen transport
5.specimen receipt
6.testing and review
6.lab interpretation
7.results reporting
8.post-test specimen
management
9.laboratory
information system
10. interpretation and
consultation
quality system essentials
1.quality program
organization
2.personnel selection,
training, education
3.equipment
4.purchasing and
inventory
5.process control
6.. documents and
records
7.occurrence management
8.internal assessment
9.process improvement
10. service, satisfaction
after NCCLS GP26-P (1998) “Quality System Model for Healthcare”
GP26
Q
U
A
L
I
T
Y
S
Y
S
T
E
M
S
• organization
• personnel
• equipment
• purchasing
• process control interpretation
patient
• records
and consultation
assessment
• occurrence
management
• internal assessment
• process improvement
• customer satisfaction
Important
aspects of care
critical to patient care
high volume


experientially problematic

Phase 1
Does the lab follow the plan?
Has the QI plan been
implemented as designed?
refer to the design document.
 based upon the document that was in effect
~ 12 months prior to the inspection.

NEW
Monitoring and Evaluation
design
measure
improve
assess
Shewhart Cycle
plan
act
do
check
Phase 2
Benchmarks of performance?
– Are key indicators of quality
monitored and evaluated for opportunities for
improvement?
Are
the chosen indicators being measured against a
benchmark such as a practice guideline, Q-Probe data,
published references, or trend analysis?
Sufficient
measure
indicators for the laboratory’s
scope of care?


Caution!


Measurement does not improve
quality.
Documentation must not become
its own goal.
Organizations may decouple
related processes.
Rigid external benchmarks stifle
quality improvement.
Phase 1
Pre-analytic measures?
Do the chosen indicators include measures of preanalytic variation appropriate to the laboratory’s scope
of care?

– transmission of physicians’ orders
– shipment of provider-collected samples
– requisition accuracy
– phlebotomy statistics
– specimen acceptability rates
NEW
Phase 1
Post-analytic measures
Do the chosen indicators include measures of postanalytic variation appropriate to the laboratory’s
scope of care?

– reflexive testing
– concordance of analytic data
– off-site printing and posting of lab reports
– report readability
NEW
Phase 2
Adequate design?
Is
design
the QI program comprehensive?
– Each section of the laboratory, e.g., chemistry,
transfusion medicine, anatomic pathology,
microbiology, hematology, etc.
– The program must include and integrate
all aspects of the lab’s scope of care, such as inpatient
and outpatient services, reference laboratory services,
satellite and point-of- care testing, and consultative
services.
Typical table of organization in
2000: • Anatomic Pathology
•
•
•
•
•
– Surgical Pathology
– Cytopathology
– Autopsy Pathology
Specimen Procurement and Processing Lab
Automated Laboratory
Manual Testing
– Microbiology
– Immunology
– Special Chemistry
– Cytogenetics
Laboratory Information Systems
Outpatient Clinic Labs
Phase 2
Problem resolution
Is there a systematic program to identify
and correct problems that may interfere
with patient care services?

– Follow a plan?
– Statistics available?
– All problems recorded?
– Resolution documented?
NEW
Mistakes are opportunities.
Phase 1
Actions taken?
 Are
appropriate actions taken whenever
opportunities for improvement are identified?
 Each opportunity should eventuate in an
appropriate action.
Records should be organized in such a way as to
facilitate identification of opportunities to improve
care.
NEW
Phase 1
Customer satisfaction
Have
the referring physicians’ and patients’
satisfaction with the laboratory service been measured
within the past 2 years?
physicians
direct
indirect
patients
telephone survey
questionnaire
referral statistics
waiting times
(examples)
NEW
Phase 2
Annual appraisal
Is the QI program appraised at least annually
for effectiveness?

–
–
–
–
–
by the director or qualified designee
new and redesigned activities
follow-up and problem resolution
address recurrent problems
revise summary document
when indicated
NEW
Phase 1
Charts and graphs?
Are
graphical tools used to communicate
quality findings effectively?
Examples:
• Pareto charts
• cause-and-effect
(fishbone)
diagrams
• frequency histograms
• trend graphs
• force-field analyses
• flow charts
NEW
Phase 2
Clinical relevancy of QI program
Is
a physician responsible for ensuring that
the program is coordinated with those of the
medical, surgical, and nursing services?
The intent is to consider quality
improvement of patient care services
a medical process.
One or more improvement
activities were chosen
after consultation with the
medical staff.
Phase 1
Is quality improving?
Is
there evidence that the laboratory’s quality has
improved in the preceding 2 years?
NEW
QI records may be peripheralized
or centralized.
QI records may be peripheralized
or centralized.
If records are distributed in many locations, summaries of
the content should be available at the central facility.
How does the CAP inspector
evaluate the QI program?
Requirements are directive but not prescriptive.
 There is an opportunity for post-inspection dialog.
 The goal is laboratory improvement.

The CAP inspector should be
aware of the facility’s needs
Where is the lab in its “QI evolution”?
 What is are the characteristics of the lab’s external
and internal markets?
 What are the lab’s customers demanding?

The program must be fair to all other
applicants.
Prepare for the inspection!
Be familiar with the Standards and the checklist.
 Anticipate your inspector’s questions.
 Organize your QI records into a presentation.
 Have examples of QI reports. Show how they’re
used to improve quality.
 Don’t be passive! Take the initiative! Show
enthusiasm!

Summary
A systematic program is essential.
 Your documentation should be complete.
 Emphasize clinical relevance.

This may be the most important part of the
entire inspection!