MONITORING QUALITY IN
POINT Of CARE TESTING
A quality indicator is defined as an objective measure evaluating
critical health care domains as defined by the Institute of Medicine (IOM)
(patient safety, effectiveness, equity, patient centeredness, timeliness, and
efficiency). In other words, a quality indicator is a tool enabling us to
quantify the laboratory’s performance by selecting a certain comparative
criterion. Any potential quality indicator needs to fulfill primarily two
inclusion criteria: it must be an indicator of laboratory functioning and it
must cater to at least one IOM health care domain. However, the quality
indicators selected should be designed to identify those events that reflect
the actual situations in question, are user friendly, are easy to measure,
provide the information for improving performance, are understandable, and
encourage prompt and suitable corrective or preventive action.
Taking into account everything that has just
been said about the continuous monitoring and improvement of the system as a
whole, it should be emphasized that the main goal is to achieve the maximum
quality with minimum waste and minimal error rate. As of clinical laboratory,
it means to offer a right patient, right service in the right moment; i.e. to provide
the reliable result from the best available sample with appropriate
interpretation and in the most cost-efficient way.
Quality
indicators
POCT
main principles do not differ significantly from those governing the central
hospital laboratory. "To get the right test for the right patient, getting
the right specimen and right results in right time, getting right patient
record and timely right treatment!" Quality indicators are measurable,
objective, quantitative measures of key system elements performance. They
indicate the extent up to which a certain system meets the needs and
expectations of the customers. Quality indicators can either be measures of
processes, outcomes or contribution of the laboratory to the patient care. They
can indicate the quality of the key, strategic (organization and management),
and support (external services and supplies, maintenance, environmental safety)
processes. It is of utmost importance that quality indicators address all three
key processes in the laboratory: preanalytical, analytical and postanalytical.
Quality
indicators are useful not only just for self evaluation but also for identifying
opportunities for implementing corrective action; performing a root cause
analysis; developing a quality improvement strategy; modifying targets or
action thresholds; reporting to interested parties; and deciding to continue
monitoring or stop monitoring the indicator.
Significance
of Quality Indicator
v Snapshot
on Laboratories supporting CT.
v Highlight
potential quality concerns.
v Identify
areas that need further quality
v improvement.
v Monitor
changes and improvements over time.
v Monitor
processes that have potential to put patients at risk!
Problems with POCT
Multi-test
menu
Multiple
test sites
Multiple
testing devices
Multiple
non-laboratory trained operators
Immediate
results availability
Immediate
therapeutic implications
Selection of QI in POCT
4 W
Ø What
will you measure?
Ø What
steps should you take to meet the target?
Ø Why
are you collecting this information?
Ø What
will you do if it indicates acceptable performance or if it does not?
Three types of problems
v Process
Problem
v Knowledge
Problem
v Behavioral
Problem
Stages in QI plan
1.Define the scope of your monitors carefully
Quality
Monitors may be unit, analyzer, section, hospital or system
2. Data
collection frequency may depend on the difficulty it takes to capture the data
3. Performance
Improvement Steps
•
Plan
•
Do
•
Check
•
Act
Targets for QI
•Competency
of personnel
•Instrument
evaluation and validation
•Method
correlation
•Instrument
maintenance
•Reporting
patient results
•External
QC
•Internal
QC
•Clinician
satisfaction
•Communication!?
•Accuracy
of patient identification (POC data management software)
Quality Indicator Data Collection
Find a way to measure…Data capture options –
•
IT Departments can be helpful in generating LIS/HIS queries
•
POC data management software
•
Manual reviews/audits
•
Your data will drive your process improvement planning
Quality Indicator Evaluation
• Evaluation Frequency is dependent upon the
Quality Indicator, and defined by the institution.
• General Evaluation Format
–
Goal :
–
Threshold:
–
Performance Data:
–
Action:
–
Comments and Review:
Here are some POCT quality indicators:
Ø number
of bad quality samples,
Ø number
of wrong samples,
Ø samples
without identification (no patient identification),
Ø sample
handling errors
Ø number
of inadequate sample – haemolytic, clotted,
Ø insufficient
sample volume, inappropriate collection container
Ø education
documentation (certification),
Ø critical
values notifications,
Ø quality
control performance (internal and external quality control),
Ø instrument
management (instrument evaluation and validation, calibration
verification, method correlation,
instrument maintenance),
Ø inventory
management (reagents and controls),
Ø incident
reports,
Ø reporting
patient results,
Ø number
of missing patient results records,
Ø number
of cases where operator didn’t detect interference,
Ø reporting
incidents, etc.
POC QM Plan QSE Components
1. Documents and Records
–
Record retention, Procedure manuals
2. Organization
–
Responsibility, licensure, accreditation
3. Personnel
–
Training, competency
4. Equipment
–
Instrument evaluation and validation, calibration verification, method
correlation,
instrument maintenance
5. Purchasing and Inventory
–
Purchasing, inventory management of reagents and controls
6. Process Control
–
Quality control frequency, remedial action, QC review, patient testing, reagent
storage
7. Information Management
–
Patient result reporting, normal/therapeutic ranges, critical results, result
review
8. Occurrence Management
–
Incident reporting, staff communication
9. Assessments
–
Proficiency testing, inspections
10. Process Improvement
–
Quality Indicators
11.Customer Service
–
Unit rounds, multidisciplinary meetings, satisfaction surveys
12.Facilities and Safety
–
PPE, Collection devices, exposure investigation
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