gerald a. hoeltge, md special commissioner for complaint investigations, ptes oversight &...

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!