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