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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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