1. Your Quality Improvement Plan
Gerald A. Hoeltge, MD
Special Commissioner for Complaint Investigations, PTES Oversight & Equivalency Determinations
CAP Laboratory Accreditation Program 1

2. 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

3. on quality improvement
6 questions
13 questions
on quality improvement

4. on quality improvement
We will point out the new questions.
13 questions
on quality improvement

5. 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

6. Grading Summary (partial example)
     Distribution of Performance by Peer Group      
LAB BGS STD EXC
Personnel and safety EXC 8.2% 51.0% 40.8%
Technical processes STD  4.3% 83.0% 12.6%
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

7. 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

8. Checklist questions on quality
INFORMATION MANAGEMENT
LAB INFORMATION SYSTEMS
SPECIMEN MANAGEMENT
REPORTING
INTERPRETATION
TESTING/REVIEW
PROCESSING
SPECIMEN TRANSPORT
SPECIMEN COLLECTION 10 20 30 40 50 60 70
after Nevalainen DE, Berte LM. CAP Today, March, 1997 4

9. 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.

10. Does the quality improvement program follow a written plan?
Phase 2
Does the quality improvement program follow a written plan?
Was it approved by the Director?
Is it comprehensive?
Is it structured? 3

11. Sahney’s Second Law of Quality Progress:
Qp = E x M2
E = employees’ commitment to quality
M = management’s commitment to quality

12. “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.

13. ISO 9000 series
1. management responsibility 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 5

14. 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

15. NCCLS Guideline GP-22 “Continuous Quality Improvement”
Team management
Plans management
Improvement  management
Selecting an improvement process
Systematic improvement in the path of workflow
The TQM interface 6

16. quality system essentials
operating systems
quality system essentials
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
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
GP26 Q S U Y A S L T I E T M Y S
after NCCLS GP26-P (1998) “Quality System Model for Healthcare” 7

17. interpretation and consultation
GP26 Q S U Y A S L T I E T M Y S
• organization
• personnel • equipment • purchasing • process control • records • occurrence management • internal assessment
patient assessment
interpretation and consultation
• process improvement • customer satisfaction

18. Important aspects of care
critical to patient care 
high volume 
experientially problematic  25

19. Does the lab follow the plan?
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 8

20. Monitoring and Evaluation
design
measure
improve
assess

21. Shewhart Cycle do
plan
check
act

22. Benchmarks of performance?
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 indicators for the laboratory’s scope of care?
measure

23. Caution! Measurement does not improve quality.
Documentation must not become its own goal.
Organizations may decouple related processes.
Rigid external benchmarks stifle quality improvement.
Caution!

24. Pre-analytic measures?
Phase 1
Pre-analytic measures?
Do the chosen indicators include measures of pre-analytic 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

25. Post-analytic measures
Phase 1
Post-analytic measures
Do the chosen indicators include measures of post-analytic 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

26. Adequate design? design Is the QI program comprehensive? Phase 2
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.
design

27. 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

28. 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.

29. 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

30. Customer satisfaction
Phase 1
Customer satisfaction
Have the referring physicians’ and patients’ satisfaction with the laboratory service been measured within the past 2 years?
physicians
patients
telephone survey
questionnaire
direct
indirect
referral statistics
waiting times
NEW
(examples) 17

31. 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 19

32. 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 14

33. Clinical relevancy of QI program
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.

34. Phase 1
Is quality improving?
Is there evidence that the laboratory’s quality has improved in the preceding 2 years?
NEW 18

35. QI records may be peripheralized or centralized.

36. 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.

37. 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.

38. 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.

39. 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!

40. Summary This may be the most important part of the entire inspection!
A systematic program is essential.
Your documentation should be complete.
Emphasize clinical relevance.
This may be the most important part of the entire inspection!