QUALITY MANAGEMENT Flashcards
Coordinated activities to direct and
control an organization with regard
to quality (ISO,CLSI).
- All aspects of the laboratory
operation need to be addressed to
assure quality; this constitutes a
quality management system.
QUALITY MANAGEMENT SYSTEM
The result should be correct
Quality
even 1% error is unaaceptable. It
should be 100%accurate.
Error-free
result is grossly abnormal and the
decision to communicate the result
urgently is made not by the attending
doctor who requested the test, but by
laboratory staff, based on preset
critical limits.
Alert Values
Achieving a 99% level of quality
means accepting a 1% error rate
Alert Values
An error in any part of the cycle can
produce a poor laboratory result.
A method of detecting errors at each
phase of testing is needed if quality
is to be assured.
COMPLEXITY OF LABORATORY
PROCESSES
LIST THE PROCESSES
- PRE-ANALYTICAL
- PRE-EXAMINATION
- POST-EXAMINATION/ POST
ANALYTICAL
Sample receipt accesioning
PRE-ANALYTICAL
-Done before the actual testing
-Preparation before the actual test
-Assess the competency of the personnel
-Personnel competency Test Evaluations
PRE-EXAMINATION
Proper preparation of the
patient for the tests required as well
as the preparation of the equipment
of the professional for the required
test.
Patient/Client Prep sample
collection
It is the section of the laboratories
where specimens are received,
sorted, entered into the Laboratory
Information System, labeled with
barcoded labels and processed
Specimen Receipt and Accessioning
It is examining “control” materials
of known substances along with
patient samples to monitor the
accuracy and precision of the
complete analytic process. The
control sample result as well as the
given known values should be the
same or aligned
Quality Control Testing
These are management tools that
help in the continuous management
of the quality system. They also help
track samples throughout the process
and identify problems. They indicate
how your staff has been operating.
Poor record keeping is often an
indication of poor performance and
disorganization. It is also important
to keep records to see if there are
changes to previous result
Record Keeping
There should be urgency of reporting
if the patient has alert values.
Reporting
WHAT ARE THE EXAMPLES OF RECORD-KEEPING AND REPORTING?
POST-EXAMINATION
sample collection
THE BEGINNING
reporting and saving of results
all processes in between.
THE END
LABORATORY TESTS ARE
INFLUENCED BY?
LIST
Laboratory environment
Knowledgeable staff
Reagent and equipment
Quality control
Communications
Process management
Incident reports.
occurrence management
Process management
set of coordinated activities that
function as building blocks for
quality management
12 QUALITY ESSENTIALS
This quality management system
model was developed by the Clinical
Laboratory Standard Institute (CLSI)
12 QUALITY ESSENTIALS
Who developed the 12 QUALITY ESSENTIALS?
Clinical
Laboratory Standard Institute (CLSI)
It is fully compatible with ISO
standards
- It Assures accuracy and reliability
throughout the Path of Workflow
12 QUALITY ESSENTIALS
The laboratory needs to be organized
around a formal quality management
system that supports consistent
procedures. The management team
and quality unit play an integral role
in a quality-driven culture, along
with structures for monitoring
ongoing quality
GIVE EXAMPLES
- ORGANIZATION
Laboratory Structure and
Management
2. Mechanism of implementing and
monitoring
3. Quality Policy-Responsibilities,
Authorities, Communication,
Provision of Sources
- Who are the Authorities and
responsible
Capable, qualified staff members are
the single most important asset to a
laboratory. Training, motivation, and
engagement are key parts of the
quality management system. You
also need to document all of your
training processes within your
quality management system
GIVE EXAMPLE
PERSONNEL
- Orientation
- Professional development
- Continuing education
- training
- Competency assessment
- Qualified and Competent, motivated
staff - CPD
- CPE
There should be a minimum of 15 units every three years
CPD (Continuing Professional
Development Points)
referring to the points professionals
receive for participating in
specialized training
CPE (Continuing professional
education)
Every piece of equipment used in the
laboratory must be maintained to
operate safely. Also, laboratories
need to monitor how equipment is
installed, which suppliers provide the
equipment, any calibration
processes, and when the equipment
needs to be replaced to maintain the
highest possible quality
GIVE EXAMPLE
EQUIPMENT
- Acquisition
- Installation
- Validation
- Maintenance Calibration
- Troubleshooting
- Service and repair
- Records
Properly managing the supply chain
is critical to ensure that raw inputs
and other supplies are consistently
high-quality. Inventory activities
should verify that materials and
supplies are stored in a way that
protects integrity. Make sure you
purchase inventory from suppliers
who also follow a quality
GIVE EXAMPLES
PURCHASING AND INVENTORY
1. Vendor qualifications
2. Supplies and reagents
3. Critical services
4. Contract review
5. Inventory management-First in and
First Out basis
- Quality Control
- Sample Management
GIVE EXAMPLES
PROCESS CONTROL
1. Quality Control
2. Sample Management
3. Method Validation- Proper Methods
should be done
4. Method Verification-Verification of
methods after validation
the lab processes patient information
such as medical exams, results, and
more. This data needs to be managed
in a way that ensures all information
is accurate, secure, confidential, and
accessible to individuals with the
right privileges, such as lab
managers and leadership.
GIVE EXAMPLES
INFORMATION MANAGEMENT
1. Confidentiality
2. Requisition- Accdg. to the urgency
3. Logs and Records
4. Reports
Documents are a similar concept to
information management, and there’s
a significant overlap between these
categories. One of the most essential
lab documents is standard operating
procedures (SOPs) to create a
standard for each process.
Documents need to be available at
the point of work, maintained,
accurate, and secure.
DOCUMENTS AND RECORDS
is any error or
non-conformance. A QMS software
can help you detect these issues and
facilitate investigations to discover
the root cause and prevent
reoccurrence. A laboratory QMS can
also assist you if you’re going
through an audit, as it’s much easier
to document these occurrences and
what you did to fix them.
GIVE EXAMPLES
OCCURENCE AND MANAGEMENT
1. Complaints
2. Mistakes And Problems
3. Documentation
4. Root Cause Analysis
5. Immediate Actions
6. Corrective Actions
GIVE EXAMPLES
A quality management system
should support the continuous
improvement of laboratory
processes
GIVE EXAMPLES
ASSESSMENT
1. INTERNAL ASSESMENT
2. EXTERNAL ASSESMENT
A quality management system
should support the continuous
improvement of laboratory
processes.
GIVE EXAMPLES
PROCESS IMPROVEMENT
1. Opportunities For Improvement
(Ofis)
2. Stakeholder Feedback
3. Problem Resolution
4. Risk Assessment
5. Preventive Actions
6. Corrective Actions
s the ultimate goal
of a laboratory. A laboratory’s QMS
should support operations that
consistently provide a positive
customer experience through the
production of consistently
high-quality products or other
missions. The laboratory needs to
understand the customers and their needs and use customer feedback for
improvement.
GIVE EXAMPLES
CUSTOMER SERVICE
1. customer group identification
2. customer needs
3. customer feedback
within laboratory, GIVE EXAMPLES
Internal Assessment
- within laboratory
- Quality Indicators
- Audit Program
- Audit Review
