gerald a. hoeltge, md special commissioner for complaint investigations, ptes oversight &...
TRANSCRIPT
Gerald A. Hoeltge, MD
Special Commissioner for Complaint Investigations, PTES Oversight &
Equivalency Determinations
CAP Laboratory Accreditation Program
Your Quality Improvement PlanYour Quality Improvement Plan
ObjectivesObjectives
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 questions6 questions
13 questions13 questionson quality improvementon quality improvement
13 questions13 questionson quality improvementon quality improvement
We will point outthe new questions.
QI is central to accreditationQI 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
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 performanceBGS = below peer group standardSTD = standardEXC = excellent
Grading Summary (partial example)
Standard IIIStandard 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
SPECIMEN COLLECTION
SPECIMEN TRANSPORT
PROCESSING
TESTING/REVIEW
INTERPRETATION
REPORTING
SPECIMEN MANAGEMENT
LAB INFORMATION SYSTEMS
INFORMATION MANAGEMENT
0 10 20 30 40 50 60 70
after Nevalainen DE, Berte LM. CAP Today, March, 1997
Checklist questions on qualityChecklist questions on quality
Why have a quality plan?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.
Does the quality improvement program follow a written plan?
Was it approved by the Director? Is it comprehensive? Is it structured?
Phase 2
Sahney’s Second Law of Quality Sahney’s Second Law of Quality Progress:Progress:
Qp = E x M2
M = management’s commitment to quality
E = employees’ commitment to quality
““Approved by the Director”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 seriesISO 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 nonconformingproduct
14. corrective action15. handling storage, pack
aging and delivery16. quality records17. internal quality audits18. training19. servicing20. statistical techniques
ISO DIS 15189ISO 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 NCCLS Guideline GP-22 “Continuous Quality Improvement”Quality Improvement”
Team management
Plans management
Improvement management Selecting an
improvement process
Systematic improvement in the path of workflow
The TQM interface
1. patient assessment2. test requests3. specimen collection4. specimen transport5. specimen receipt6. testing and review6. lab interpretation7. results reporting8. post-test specimen
management9. laboratory
information system10. interpretation and
consultation
1. quality program organization
2. personnel selection,training, education
3. equipment4. purchasing and
inventory5. process control6..documents and
records7. occurrence management8. internal assessment9. process improvement
10. service, satisfaction
operating systemsoperating systems quality system essentialsquality system essentials
after NCCLS GP26-P (1998) “Quality System Model for Healthcare”
GP26
Q SU YA SL TI ET MY S
patientassessment
interpretationand consultation
• personnel• equipment• purchasing• process control• records• occurrence management• internal assessment
• organization
• process improvement• customer satisfaction
GP26
Q SU YA SL TI ET MY S
ImportantImportantaspects of careaspects of carecritical to patient care high volume experientially problematic
Does the lab follow the plan?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.
Phase 1
NEW
Monitoring and EvaluationMonitoring and Evaluation
measure
improve
design
assess
Shewhart Cycle
do
act
plan
check
Benchmarks of Benchmarks of performance?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’sscope of care?
measure
Phase 2
Measurement does not improve quality.
Documentation must not become its own goal.
Organizations may decouple related processes.
Rigid external benchmarks stifle quality improvement.
Caution!
Pre-analytic Pre-analytic measures?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
Phase 1
NEW
Post-analytic Post-analytic measuresmeasures
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
Phase 1
NEW
Adequate design?Adequate design?
Is 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.
design
Phase 2
Typical table of organization in Typical table of organization in 2000:2000: • 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
Problem Problem resolutionresolution
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?
Mistakes are opportunities.
Phase 2
NEW
Actions Actions taken?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.
Phase 1
NEW
Customer Customer satisfactionsatisfaction
Have the referring physicians’ and patients’ satisfaction with the laboratory service been measured within the past 2 years?
physicians patients
direct
indirect
telephone survey questionnaire
waiting timesreferral statistics
Phase 1
NEW(examples)
Annual Annual appraisalappraisal
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
Phase 2
NEW
Charts and graphs?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
Phase 1
NEW
Clinical relevancy of QI programClinical relevancy of QI programIs 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.
Phase 2
One or more improvement activities were chosen
after consultation with the medical staff.
Is quality Is quality improving?improving?
Is there evidence that the laboratory’s quality has improved in the preceding 2 years?
Phase 1
NEW
QI records may be QI records may be peripheralizedperipheralized or centralized.or centralized.
QI records may be peripheralized QI records may be peripheralized or or centralizedcentralized..
If records are distributed in many locations, summaries of the content should be available at the central facility.
How does the CAP inspector How does the CAP inspector evaluate the QI program?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 The CAP inspector should be aware of the facility’s needsaware 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!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!
SummarySummary A systematic program is essential. Your documentation should be complete. Emphasize clinical relevance.
This may be the most important part of the entire inspection!