quality assurance shree baboolal 12 th february, 2005
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QUALITY ASSURANCE
Shree Baboolal
12th February, 2005
Quality Assurance in Healthcare
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
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)
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
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
Joint Commission on Accreditation of Healthcare Organizations (JCAHO)– 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
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
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
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
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
Certificate is obtained based on the complexity of testing
Three categories of testing are recognised– 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
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
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
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
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
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
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
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
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
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
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
Patient preparation procedures Specimen collection procedures
– Identification– Equipment
- puncture device- evacuated tubes
Labeling Technique Collection priorities Delta checks
Documentation
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
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
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
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
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
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
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
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