Learning Outcome 1-OBJECTUVE ONE

DEFINITIONS
• Quality is defined as "excellence" or the degree of excellence".
• Risk is the degree of possibility of unwanted negative consequences of an event happening or
the possibility that quality may be compromised.
• Control implies that one has the ability to determine the level of quality that may be provided.
• Management considers the planning, organizing, coordinating, directing, controlling, and
supervising of any business activity with responsibility for results.
• Assurance indicates that one will guarantee that quality (to the best of one's ability) will be
provided.
• Quality Assurance or QA in the clinical laboratory, includes all the actions a laboratory takes
to ensure quality results.
• Risk Management is part of QA and is the process of identifying potential risks and finally
choosing and implementing a preferred action that affects or manages those risks.
• Quality Control or QC is the control of the process of assaying patient samples. Therefore,
whenever patient samples are analyzed by a method, some measure of control exists to
monitor this method, QC is also a part of QA and is a procedure done by all laboratory
personnel regardless of the discipline that one is practising.

KEY ELEMENTS OF A QA PROGRAM

The key elements of a quality assurance program in a laboratory must involve the following three
areas: technical, human resources and administrative.

Technical Component of Quality Assurance

This particular area is only a part of the whole QA program at a clinical site and specifically
impacts on the quality control of reagents and testing procedures, maintenance of equipment and
proficiency testing within the laboratory. Think of the busy routine clinical chemistry laboratory
with the many pieces of equipment doing many different tests, and it is easy to see that all of these
technical factors will play an important role in providing quality patient care. Keeping up with the
documentation and having policies in place at the facility to ensure that the technical factors are
monitored is a very important part of this area. Technical staff in each discipline take on the
responsibility for ensuring that the goals of the facility are met.

Human Resources Component of Quality Assurance

The quality of service to patients will be directly proportional to the competence and training of
the staff in the healthcare facility. This particular component focuses on those factors that have an
impact on human resources, such as qualifications of staff and staffing level requirements
orientation procedures, continuing education, performance appraisals, staff meetings and surveys.

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 It is important for each facility to start with identifying the specific Education and experience for
each position in a job description. Quality in staff will further be maintained if they begin with a
strong orientation to the job site when they first start, have regular opportunities to take courses,
and receive further feedback in the form of appraisals and open communication during staff
meetings. Policies reflecting the factors in this component should be in place at the healthcare
facility.

Administrative Component of Quality Assurance

This component adds the role of management practices into quality assurance. These practices
complement the previous two components. Regular review and revision of policies and
procedures provide the basis on which everything else runs. Other factors included in this
component are inventory control practices to provide adequate and fresh resources, maintenance
of a safe working environment and providing incident reports to cover the problems that
potentially could occur with all aspects of quality assurance. Surveys for those groups that are
involved with the laboratory service (e.g. physicians and patients) are a useful tool to receive
external feedback on the service and help in dealing with more specific issues. Management also
has laboratory statistics to use as a tool in quality assurance to ensure appropriate allocation of
resources.

OBJECTUVE TWO

DEFINITIONS
As changes in quality assurance models have occurred, new key words or phrases have become
more popular and prevalent. This activity will explore the meanings and relevance of some of
these new words or phrases.

• Quality in Objective 1 was defined as "degree of excellence". It can no expanded and

clarified to "providing consistent services which meet or exceed needs of the customers
(patients)".
• A (TARGET) benchmark serves as the standard of excellence or perform level against
which a process, in this case laboratory service, is measured. If the service does not meet a
certain benchmark, then the quality must be improved.
• Quality improvement then, is the activity associated with improving laboratory's ability
to meet and exceed the needs and expectations of the patient.
• Total Quality Management (TQM) can be defined as the " achievement of quality as a
continuous process involving all personnel at all levels of an organization in the pursuit of
excellence in every process, with the ultimate objective being quality patient care ". To
facilitate TQM, all employees must be empowered.
• Empowerment means providing staff with opportunities, the authority, and resources to
settle quality issues in which they are directly involved.

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• Accreditation is a non - governmental, external, peer review process for assessment of
healthcare facilities, laboratories, or educational programs against a certain benchmark. It
provides a professional judgement about the quality of the facility , etc. and encourages
continued improvement . It also provides a good indication for the public that each accredited
facility, etc. is capable of functioning at the required level of competence.

TQM PHILOSOPHY

Given the current and future workforce TQM requires a major paradigm shift. Managers must
become leaders and focus on developing new skills and behaviors. This may be very difficult to
do because individuals may perceive change as a threat. However, healthcare providers are
being attacked on many fronts because patients and governments perceive a lack of value for
the money being spent on healthcare. Minor changes are not likely to affect this but whole new
models of care, management and financing must be formed.

Traditional Leadership TQM Leadership

Central, hierarchical control Coordination, facilitation,
Internal focus integration,coaching
Quantity Customer focus
Quality
Central leadership , individual Plan , Direct , Leadership shifts to empower people , groups
Control , team effort Facilitate , Listen , develop
Resistant to change Open to change
Suspicion Trust
Compliance Commitment
Detection Prevention

TQM takes a more " holistic " approach to providing quality patient care than quality assurance
alone. The laboratory is just one player in a healthcare facility. Previously it was important to
meet predetermined standards and if these were met, the public could be " assured " that
everything was going well. TQM allows any service at any time to be improved. A disaster does
not need to happen before any action takes place. In QA, a problem is a disaster, a call to
immediate action so improvements occur more sporadically. In TQM problem is an
opportunity to improve the system and changes are incorporated continually. TQM does not
replace QA programs but rather utilizes these as monitors for continuous quality
improvement.

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 Characteristic Quality Assurance Total Quality Management
Purpose Improve quality of care for Improve quality of all services
patients. and products for patients and
other clients.
Scope •Focused on specific • Focused on whole processes
problems/ individuals / systems
• Works to endpoints • Has no end points
Leadership • Centralized - clinical leaders • Decentralized - part of
• QA committee for each everyone's job clinical
department and non - clinical.
• Little top management • Organization wide - total
involved. involvement
• Externally driven • Top management lead
• Internally driven

Aims Problem solving as a means of " Continuous improvement even if

assuring quality no problem identified
Outcomes • Improves performance of • Improves performance of
few individuals everyone involved
• Creates defensiveness, • Reduces threat to
turf protection individual promotes team
spirit, breaks down turf
lines

OBJECTUVE THREE

INTERNAL QUALITY ASSURANCE PROCEDURES

These procedures are focused around the testing of patient clinical samples and the monitoring takes
place by the facility or department itself and so are called " internal ".

There are many factors that may affect the validity of the test results. Those that precede the actual
testing are called pre - analytical variables. Those that are part of the actual testing are called
analytical variables. And finally, there are those that follow the actual testing procedure and are called
post analytical variables.

Pre - Analytical Phase

This phase ensures quality in everything that precedes the testing process both within and outside
the lab. Since this has an impact on other individuals the laboratory, they must also be involved in
helping to monitor the QA process.

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Processes within the Pre-analytical Phase

1. Correct ordering of tests: The laboratory must consult with physician regarding the
laboratory tests available to fit their diagnostic and monitoring needs. The physician should
look to the lab personnel to give the best advice on proper ordering and sequencing of tests.

2. Preparation of the patient: The patient should have enough information about test orders so
that they are not anxious about the collection of a test sample and are adequately prepared.
For example, some tests require fasting conditions or medication restrictions.

3. Correct identification of the patient by the phlebotomist: The name and identification on
the collection sample and the requisition must match each other and must also match the
correct patient.

4. Proper collection of the sample: The sample must be collected in the correct container and
under conditions specified by the test procedure.

5. Timely transportation of the sample to the laboratory: The time between collection and
point of analysis should be within limits defined by the laboratory.

6. Proper handling of the sample from time of transport to time of analysis: this may
include avoiding exposure to extremes in the environment or keeping the sample on ice. All
samples should be handled as though they are infectious.

7. Proper handling of the sample within the lab: This includes correct documentation of
sample identification within the lab, correct centrifugation techniques, correct fixation
techniques, and timely separation of the red cells from the serum or plasma .

These procedures cannot be verified or monitored by traditional statistical procedures. The usual
indicator for a lapse in quality is a complaint.

Analytical Phase

The analytical phase is the process involved in the analysis of a patient sample in the clinical
laboratory. Traditionally, this was the only area of concern for the lab, but different work methods
have required an expansion of QA programs. Internal and external QC programs are involved in the
process of analytical QA; however, a number of other procedures are also involved.

Processes within the Analytical Phase

1. Proper labeling and use of reagents. Reagents must be labelled with concentration, lot number,
date of preparation or time put into use, expiration date, and initials of preparer.

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 2. Periodic calibration of pipetting devices.
3. Preventative maintenance of instruments.
4. Periodic checking of water purity.
5. Periodic checking of the temperatures of refrigeration or heating units
6. Periodic checking of the accuracy of all analytical balances and thermometers
7. Periodic verification of the accuracy of centrifuge speeds and timing devices
8. Periodic checking that procedure manuals are complete and up to date
9. Constant assurance that safety procedures are followed
10. Use of critical ranges in addition to the reference ranges when verifying patient results

These processes are usually monitored by function sheets or periodic written verification that these
procedures are followed on a regular basis. These written verifications may be in the form of
checklists that the laboratory technologist must initial as the functions are performed. These sheets
are then verified at periodic intervals by a supervisor for completeness and compliance.

Post Analytical Phase

Post analytical QA is the process of verifying quality in all procedures that occur before the report
leaves the laboratory and is in the hands of the physician or care giver. The use of correct reference
intervals is an important area of post analytical QA, however, several other processes are involved.

Processes within the Post Analytical Phase

1. Verification of calculations on final reports - includes correlation to clinical diagnosis and other
lab tests, intralab duplicates, delta and limit checks and "mean of normal".
2. Cumulative reporting - ensuring there is a consistency of results from day to day.
3. Review of test results for test completion and possible transcription errors.
4. Reports that are easy to read and interpret.
5. Procedures for informing the physician of results that require immediate attention
6. Timeliness of reporting values to patient charts i.e. TAT: turn around time.
7. Constant interaction with the institution to ensure quality in direct patient care as a result of
lab tests.

The monitoring of this section of QA usually takes two forms. One is the process described for pre -
analytical QA in that a lapse in this area may be identified as a complaint. The other type of
monitoring for quality is by an ongoing assessment of the impact of lab results and procedures in the
institution that the lab services. These ongoing assessments usually occur as a result of quality circles,
QA committees or review committees. The focus of these groups is not to solve problems, but rather
to prevent them from happening.

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EXTERNAL QUALITY ASSURANCE PROCEDURES
External Quality Control Program

External quality control refers to the process of retrospectively comparing results from different
laboratories using quality control samples and statistical evaluation supplied by an external agency. The
major purpose of external quality control is to assess the lab's accuracy. This is done by comparing
results to previously established target values and/or comparing results to other laboratories with
similar methodologies. These programs may be either in the form of regional quality control programs
which are available from major manufacturers or from various professional organizations or a
proficiency testing program - the most developed and well known is by the College of American
Pathologists (CAP).

Quality Assurance Audit

This is a process used to assess whether a QA program is working effectively. In a narrow focus for
example, a QA audit could be achieved by reviewing the daily QC data in the laboratory before releasing
results. It could also include an evaluation of all the processes in the laboratory used to ensure accurate
and reliable results for quality patient care. In a much broader sense, this could be done to a healthcare
facility to assess if the QA program it has in place is effectively achieving the objectives of the facility to
provide quality patient care.

Continuous Quality Improvement (CQI)

These are processes undertaken by a facility to move to an improvement of the existing level of
performance on an ongoing basis. These processes are often used synonymously with TQM.

ISO/TC212 Standards

Current Good Manufacturing Practices (cGMP)

These are regulations established by the FDA (Food and Drug Administration) of the USA. This
organization mandated that cGMP regulations apply to specific sectors of health care and the health care
industry - manufacturing, processing, packing or holding of drugs, pharmaceuticals, blood and blood
components , medical devices , etc. These are mandatory and compliance is enforced. They do serve as
part of quality assurance which is aimed at ensuring that these products are consistently manufactured
to a quality appropriate for their intended use. The FDA has no jurisdiction in Canada, and therefore
healthcare facilities are not required to adhere to these regulations. However, results of the Kreve Inquiry
will have a great impact on the future use of blood products in Canada and cGMP's may have an impact on
the future of the Canadian health scene overall.

Hazard Analysis Critical Control Point (HACCP)

This is a QA system used primarily in the food industry. It is a system of checks and balances throughout
the whole operation to prevent problems rather than only testing the product at the end of the process to
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find it does meet the standard of quality and needs to be discarded. This is accomplished through
identifying critical points where potential problems can occur, continual monitoring of these critical
points and maintaining documentation if a problem occurs and how it was corrected.

PROBLEM SOLVING

Because problems related to patient care do occur in spite of the best quality assurance activities, each
laboratory should have a mechanism in place for solving problems. For example, a lapse in quality in any
of the pre - analytical variables is indicated by a complaint or a report of a quality-compromising event.
The problem must first be clearly defined, separating it from all emotions and opinions. This includes a
formalized process that defines the indicator of the possible lapse in quality, the standards of
performance for the indicator, and the mechanisms for monitoring the performance - a plan of action. All
affected areas should participate and set up the action plan Monitoring incorporates the following:

• What is the data source? i.e. medical records, chart reports,etc..

• What method to use? i.e. manual, computer generated
• How often to do? i.e. continuous, selected days, hours over a selected time period
• When to do? i.e. on retrospective, concurrent, or prospective data
• Who to do? i.e. technologist, nursing staff, support staff

After the action plan has been completed , on evaluation must take place in a timely fashion - not six
months later. It should be done by one or more individuals . The evaluation report should include a brief
description of the problem , the action plan and monitoring mechanisms , a summary of the results and
any recommendations . One possible recommendation is that the problem is solved and the monitoring
can be stopped. Another recommendation is to continue the monitoring on an ongoing basis . When
results of the evaluation show that the criteria were not met or the problem is continuing , the next step
is to take action and correct the problem . This may mean a change in procedures or methods , training or
retraining of staff , purchase of different equipment or changing responsibilities . When changes are made
, the monitoring must continue and subsequent evaluation reports should document action taken and
results of action taken.

Summary of Problem Solving Process:

input - Advice , Plans , Complaint

Define Problem - Indicator , Standards of Performance

Monitor

Document and Evaluate

No Problem Results Inconclusive Problem Confirmed

Stop Monitoring Continue to Monitor Take Action Page 8 of 11

Continue to Monitor
 An example of this process is described below:

Input: A phlebotomist complains that inpatients are never properly identified.

Indicator: The phlebotomist finds an inpatient without a wristband.

Standard: All inpatients must have wristbands when they are admitted to hospital.
No procedure will be performed on a patient unless they have a wristband.

Monitor: Effective immediately, the number of patients without wristbands will be

counted for the next 30 days by the phlebotomy team.

Evaluate: The lab supervisor will evaluate the data and give her recommendations
the nursing supervisor.

Document: The lab supervisor will document the entire process including the results
from monitoring, recommendations for further action, and any results of any
corrective action that was taken.

After 30 days, if the laboratory discovers that the report from the phlebotomist was not an
isolated incident, a compromise in quality has been identified and must be corrected . The correction
requires the co - operation and involvement of several areas of hospital personnel. It is important to
remember the patient when any problems arise. Rather than pointing fingers at any group or individual ,
it is through continuous inter - department co-operation and maintenance of good communication skills ,
that problems can be corrected and changes can be implemented smoothly . Once a tentative solution to
any problem has been reached, the lab monitors the identification process for another specified time to
ensure compliance.

Learning Outcome 2-OBJECTUVE ONE

PRE - ANALYTICAL ASPECTS OF QUALITY ASSURANCE

Manuals

Policy manuals are documents that outline the position of the healthcare facility on a wide range of
administrative and operational issues. The primary objective is to ensure effective communication
between members of the institution. They represent, in a global sense, how everything must be done in a
specific setting. They provide management with a useful tool to " assure " the patients that the facility is
meeting a certain standard of quality in its work. They provide all staff, MLTs and CLXTs for example,
with a blueprint for how the work in the laboratory should be run and that they are required to follow
these policies. These are different from procedure manuals which are documents that provide
explanations and step - by - step instructions on how to perform a task, test, or process. These policy
manuals may be internal (for the use of the laboratory) or external (directed at the users of the
laboratory - nurses , doctors , patients ) . They cover every conceivable topic -specimen collection and
transport within the facility, laboratory safety specific methodology in all disciplines, etc. An example of a
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policy that applies to both a healthcare facility and the laboratory is the one that covers the
confidentiality and release of test results for patients. Rules and guidelines of a variety of agencies govern
the functioning of the hospital and laboratory (e.g.., CCHSA see Module 1) and policy manuals must reflect
this. These manuals should be placed in a location with easy access to all staff. They must be " living "
documents and therefore regularly revised or updated to adjust to the rapidly changing environment in
which the laboratory operates. reassurance to the public of a quality facility cannot be given if these types
of the documents are not in place.

Laboratory Logs

Laboratory logs are the internal manual or computerized records of patient specimens arriving at the
specific department. Specimens must be logged properly so that a correct train of events will follow .
Important information would include the patient and physician names , collection date and time , test
results and completion date . This process would be facilitated by the use of bar coded specimen labels
and a computerized information system.

Test Appropriateness / Utilization

Laboratory tests are ordered to help a physician diagnose and treat a patient . They may be ordered for a
specific purpose or in an established pattern for a certain provisional diagnosis . Prior to healthcare
reform , some of the laboratory testing had been excessive . For example , a patient may go to see the
family doctor or a walk-in clinic and have a blood test ( hemoglobin , white cell count ). If the patient had
to be admitted to the hospital , the same blood tests likely would be repeated . Also in healthcare facilities
with a medical school , many more blood tests would be ordered to help the resident learn more about
the patient's progress . Sometimes a standing order for a blood glucose would have been forgotten to be
cancelled and the patient would be needlessly poked with a needle for perhaps days before the mistake
was noticed. Now, medical schools are attempting to teach the new physicians to be more selective with
their ordering practices and to try to order the correct tests for their patients . In fact, some provincial
governments monitor the ordering practices of physicians and will refuse to reimburse a physician if the
ordering is excessive. Also, with healthcare reform , the cost factor is making a big impact . Likely ,
monitoring will increase and utilization of certain tests may decrease or even be dropped at a later time .

Test Turn Around Time (TAT)

As part of quality assurance for specimen collection, the time of collection must be recorded . The time to
test and the time to get the results on the patient's chart can be calculated. This chain of events can be
monitored as to delivery and processing problems and corrective procedures required. Results being
held up for extended periods of time may compromise the treatment procedures and therefore the
general health of the patient.

Quality patient care can be provided by any healthcare facility when a patient is not subjected to needless
and improper testing and is not kept waiting endlessly for laboratory results to return.

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 Patient Related Issues

Patient Identification

Think of the impact on quality of care if a blood sample was drawn from the wrong patient ! Incorrect
test results could alter the course of treatment and delays in recollecting could compromise the health of
the patient who wasn't tested . Think of the patient who was unnecessarily poked with a needle, the
waste of resources involved in repeating the testing , and the stress for the patients , staff , and
management ! Proper patient identification is a vital first step.

Patient Preparation

The purpose of preparing patients is to ensure they understand the importance of following directions to
produce the best sample for testing. If they don't follow the directions, specimens may have to be
recollected and this delays the results being released to the physician. Printed directions stated clearly
and simply with diagrams, if possible, are valuable for consistency in specimen collection. This is also
very helpful for patients who have English as a second language. It is equally important for laboratory
staff to be familiar with all specimen collection protocols, especially for those specimens that will be
referred out to another testing site, e.g. The Canadian Blood Services policy for collecting blood samples
for transfusion. Preparing the patient also helps to alleviate any stress or worry about the testing process.

Once the patient has been properly identified and the process of collecting the sample been explained to
the patient the laboratory worker can now move with confidence to the next step of obtaining the
specimen.

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