QUALITY ASSURANCE
Shree Baboolal
12th February, 2005
Quality Assurance in Healthcare
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All management systems are now focused
on getting the job done.
All promise more efficient and effective
management
Some have been effective in making larger
profits while others have been effective in
providing a better service to the client
Total Quality Management (TQM
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First introduced by Dr. W. Deming - 1988
Used statistics to analyze production processes and
discover the source of product flaws
Workers actively participate in decisions to improve
production – team effort
Total involvement from all levels
Quality improvement reduces waste and leads to
improved productivity
Quality Improvement (QI)
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Now part of accreditation requirements for all
types of healthcare facilities and found in
every aspect of healthcare including
phlebotomy procedures.
One way to improve quality is through the
use of national standards and regulations.
National Standard and Regulatory
Agencies
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Joint Commission on Accreditation of Healthcare
Organizations (JCAHO)
College of American Pathologists (CAP)
Clinical Laboratory Improvement Amendments of
1988 (CLIA ’88)
National Committee for Clinical Laboratory
Standards (NCCLS)
National Accrediting Agency for Clinical Laboratory
Sciences (NAACLS)
National Standard and Regulatory
Agencies
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Joint Commission on Accreditation of
Healthcare Organizations (JCAHO)
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Voluntary, non-governmental agency
Establish standards for the operation of
healthcare facilities
1994, JCAHO required all healthcare facility to
have a TQM/CQI plan in place
Ongoing evaluation of customer satisfaction
Current standards from JCAHO
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Healthcare facility must be directly accountable to
their customer
Must evaluate and track complaints about quality of
care
Created an office to monitor complaints – Office of
Quality Monitoring
Quality Incident form
JCAHO reviews reports and depending on the
nature of the report will do the following:
JCAHO will
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Request from the organization a written
response to the reported concern
Conduct an onsite assessment of the report
Incorporate the concern on their database to
see trends or patterns in performance
Review the reported concern at the next
accreditation survey
College of American Pathologists
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Outgrowth of the American Society of Clinical
Pathologists
Membership – board certified pathologists
Offers proficiency testing
Laboratory inspection – team made up of
pathologists and lab managers
Clinical Laboratory Improvement
Amendments of 1988
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These are federal regulations passed by congress
Establish standards that apply to all health facilities
including laboratories
Aim is to ensure accuracy, reliability and timeliness
of patient test results
Standard address quality assurance, quality control,
proficiency testing, laboratory records and personnel
qualifications
CLIA continued
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Certificate is obtained based on the complexity of
testing
Three categories of testing are recognised
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Waived complexity
Moderate complexity
High complexity
Complexity of testing is based on the difficulty in
performing the test and the degree of harm to a
patient if the test is performed inaccurately
CLIA continued
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CLIA requirements are more stringent for
moderate and high complexity testing
These facilities are subject to routine
inspections
Specimen collection is an important part of
CLIA inspection
Required to have written protocols for all
procedures
National Committee for Clinical
laboratory Standards
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International, non-profit educational organization
Has representation from the profession, industry and
government
Use a consensus process to develop voluntary
guidelines and standards for laboratories
Phlebotomy and certification examination questions
are based on these guidelines and standards
National Accrediting Agency for
Clinical Laboratory Sciences
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Recognised by the United States Department
of education as an authority on educational
quality
Non-profit organization
Provides either accreditation or approval for
clinical laboratory educational programs
Approves process for phlebotomy programs
to ensure competencies are met
Quality Assurance in Phlebotomy
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Laboratory testing is an important part of
patient diagnosis
A major part of patient care
Doctors rely on validity of test results
Pre-analytical factors such as patient
preparation, specimen collection procedures
and specimen handling can affect the validity
of test results
Quality Assurance in Phlebotomy
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All the procedures should be based on
specific guidelines
Phlebotomists should adhere strictly to these
guidelines
Established policies and procedures fall
under an overall process called Quality
Assurance (QA)
QA defined
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QA is defined as a program that guarantees
quality patient care by tracking outcomes
through scheduled reviews
Guidelines are developed for all the
processes and when formally adopted
becomes the QA program
QA Indicators
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Tool to monitor and evaluate all processes
Must be measurable, well defined, specific,
objective and clearly related to an important
aspect of care
Indicators can measure quality, adequacy,
accuracy, timeliness, effectiveness, customer
satisfaction etc.
Thresholds and Data
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Threshold values must be established for all
clinical indicators
Threshold value – level of acceptable
practice
If levels of care is unacceptable – corrective
plan is established
Monitor and evaluate continuously to ensure
quality improvement
Process and Outcomes
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To change outcome we must look at process
Follow process from start to finish to see where there
might be obstacles – or where the problem lie
To ensure that the same process is always followed,
there must be controls and checks along the way
The use of controls in a process is known as Quality
Control
QC defined
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Component of a QA program
Procedure control
QC process in phlebotomy involves checking all the
operational procedures to make certain they are
performed correctly
QA is overseen by the supervisor in the Phlebotomy
department
The phlebotomist must ensure that they meet
standards at all times
Areas of Phlebotomy subject to QC
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Patient preparation procedures
Specimen collection procedures
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Identification
Equipment
puncture device
evacuated tubes
Labeling
Technique
Collection priorities
Delta checks
Documentation
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Major component of QA program
QA documents have been developed to: standardize procedure, inform nursing
personnel on importance of patient
preparation and record problems
Can be used for legal purposes as well
Can provide information for QA purposes
Patient medical records
User manual
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Example of QA documentation
Chart or type form
Contains information on minimum amount of
specimens required, special handling
desired, reference values, TAT etc.
Procedure Manual
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Standardization purposes
Must be updated annually
Written in a special format – NCCLS
States laboratory policy and procedures that
apply to each test in the lab
Information found in a Procedure
Manual
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Purpose of the procedure
Specimen type and collection method
Equipment and supplies required
Detailed step-by-step procedure
Limitations and variables of the method
Corrective actions
Method validation
Normal values and references
QA Forms
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Accreditation standards for agencies require
the facility to show documents on all quality
control checks and other QA activities
QA forms include equipment check forms
and incident/occurrence report forms
Equipment check forms
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Special forms for recording checks on tube
additives, vacuum strengths and expiration
dates – verification of new lot numbers
Refrigeration temperatures – recorded daily
Control checks on centrifuge – tachometer
readings and maintenance performed
Incident reports
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Must be filled out when a problem occurs
Identifies the problem, state the
consequence, and describe the corrective
action
Should not be used to place blame
Should be used to ensure that the event
does not reoccur