QUALITY ASSURANCE

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

QUALITY ASSURANCE