TOTAL QUALITY MANAGEMENT  Measure the quantity of a particular substance in a sample

Measurements should be both accurate and precise

 QUALITATIVE EXAMINATIONS METHODS

Quality Management  Examinations that do not have numerical results:
o Growth or no growth
o Positive or Negative
Quality System o Reactive or Non-Reactive
o Color change
Quality  SEMI-QUANTITATIVE EXAMINATION METHODS
Assurance
 Results are expressed as an estimate of the measured
substance:
o “trace amount”, “moderate amount,” or “1+, 2+,
or 3+”
Quality Control o number of cells per microscopic field
o titers and dilutions in serologic tests

 Quality Management: Policy, Objective, Commitment and Direction

 Quality System: Organization, Structure, Responsibility, Accountability
 Quality Assurance: Internal QA, External QA
 Quality Control: Operational and Technical Activities on Fulfilling Quality
Requirements

 TQM FRAMEWORK INVOLVES

 Quality Laboratory Processes (QLP)
 Quality Control (QC)
 Quality Assessment (QA)
 Quality Improvement (QI)
 Quality Planning (QP)  QUALITY ASSURANCE VS QUALITY CONTROL
 Quality Goals  Quality Assurance an overall management plan to guarantee
the integrity of data (The “System”)
 QUALITY CONTROL AND QUALITY ASSURANCE  Quality Control a series of analytical measurements to
assess the quality of the analytical data (The “Tools”)

 DEFINITION (1)
 Quality Control - QC refers to those measures that must be
included in each assay to verify that the test is working
properly.
 Quality Assurance - QA is defined as the overall program
that ensures that the final results reported by the laboratory
are correct
 "The aim of quality control is simply to ensure that the results
generated by the test are correct. However, quality
assurance is concerned with much more: that the right test is
carried out on the right specimen, and that the right result
and right interpretation is delivered to the right person at the
right time"

 DEFINITION (2)
 DEFINITON (QC)
 Quality Control (QC) is part of quality management focused
on fulfilling quality requirements ISO 9000:2000 (3.4.10)
 QC is examining “control” materials of known substances
along with patient samples to monitor the accuracy and
precision of the complete examination (analytic) process.
 PURPOSE
 The goal of QC is to detect errors and correct them before
patients’ results are reported
 Quality Assessment - Quality assessment (also known as
proficiency testing) is a means to determine the quality of the
results generated by the laboratory. It is usually an external
evaluation of the laboratory's performance. Internal quality
assessment programs can also be instituted. Quality
assessment is a challenge to the effectiveness of the QA and
QC programs.
 Quality Assessment may be external or internal. Examples of
external programs includes NEQAS, HKMTAA and Q-probes

 VARIABLES THAT AFFECT THE QUALITY OF RESULTS

 QUANTITATIVE EXAMINATIONS
  The educational background and training of the laboratory  WESTGARD RULES
personnel  The formulation of Westgard rules were based on statistical
 The condition of the specimens methods. Westgard rules are commonly used to analyses
 The controls used in the test runs data in Shewhart control charts.
 The interpretation of the results  Westgard rules are used to define specific performance limits
 The transcription of results for a particular assay and can be used to detect both random
 The reporting of results and systematic errors.
 There are six commonly used Westgard rules of which three
 ERRORS IN MEASUREMENT are warning rules and the other three mandatory rules.
 True value - this is an ideal concept which cannot be  The violation of warning rules should trigger a review of test
achieved. procedures, reagent performance and equipment calibration.
 Accepted true value - the value approximating the true value,  The violation of mandatory rules should result in the rejection
the difference between the two values is negligible. of the results obtained with patients’ serum samples in that
 Error - the discrepancy between the result of a measurement assay.
and the true (or accepted true value).
 LEVEY JENNINGS CHART
 RANDOM ERROR
 An error which varies in an unpredictable manner, in
magnitude and sign, when a large number of measurements
of the same quantity are made under effectively identical
conditions.
 Random errors create a characteristic spread of results for
any test method and cannot be accounted for by applying
corrections. Random errors are difficult to eliminate but
repetition reduces the influences of random errors.
 Examples of random errors include errors in pipetting and
changes in incubation period. Random errors can be
minimized by training, supervision and adherence to
standard operating procedures.

 SYSTEMATIC ERROR
 An error which, in the course of a number of measurements
of the same value of a given quantity, remains constant
when measurements are made under the same conditions,
or varies according to a definite law when conditions change.
 Systematic errors create a characteristic bias in the test
results and can be accounted for by applying a correction.
 Systematic errors may be induced by factors such as
variations in incubation temperature, blockage of plate
washer, change in the reagent batch or modifications in
testing method.
 SYSTEMATIC VS. RANDOM ERRORS
 Systematic Error – Available error due to controllable
variables in a measurement
 Random Errors – Unavailable errors that are always present
in any measurement. Impossible to eliminate
 WARNING RULES
 Warning 12SD: It is violated if the IQC value exceeds the
mean by ±2SD. It is an event likely to occur normally in less
than 5% of cases.
 Warning 22SD: It detects systematic errors and is violated
when two consecutive IQC values exceed the mean on the
same side of the mean by ±2SD.
 Warning 41SD: It is violated if four consecutive IQC values
exceed the same limit (mean ±1SD) and this may indicate
the need to perform instrument maintenance or reagent
calibration.

 TRUE VALUE VS. MEASURED VALUE

 True Value – The known, accepted value of a quantifiable
properly
 Measured Value – The result of an individual’s measurement
of a quantifiable properly

 ACCURACY VS. PRECISION

 Accuracy – How well a measurement agrees with on an
accepted value
 Precision – How well a series of measurements agree with
each other
  MANDATORY RULES
 Mandatory 13SD: It is violated when the IQC value exceeds
the mean by 3SD. The assay run is regarded as out of
control.
 Mandatory R4SD: It is only applied when the IQC is tested in
duplicate. This rule is violated when the difference in SD
between the duplicates exceeds 4SD.
 Mandatory 10x: This rule is violated when the last 10
consecutive IQC values are on the same side of the mean or
target value.
 FOLLOW-UP ACTION IN THE EVENT OF A VIOLATION
 There are three options as to the action to be taken in the
event of a violation of a Westgard rule:
o Accept the test run in its entirety - this usually
applies when only a warning rule is violated.
o Reject the whole test run - this applies only
when a mandatory rule is violated.
o Enlarge the greyzone and thus re-test range for
that particular assay run - this option can be
considered in the event of a violation of either a
warning or mandatory rule.
MEDICAL TECHNOLOGY ETHICS
 Are ethical problems associated with medical practices and
bioscience
 Ethical problems are brought about by the advances in
biotechnology and its power over life and death
 A field of applied ethics that studies moral values and
judgements as they apply to medical technology
 Are as set of norms, values, principles that serve as
guidelines for medical technology practitioners in making
decisions in clinical settings
 TYPES OF ETHICS
 General Ethics - presents truths about human acts from
which the general principles of morality is deduced
 Special Ethics – involve the application of the principles of
general ethics in different departments of human activity both
at the individual and social levels
o Individual Ethics – concerned with GOD, self
and fellow human beings
o Social Ethics – concerned with family, the state
and the world
o Professional Ethics
o Media Ethics
 PROFESSIONAL ETHICS
 A branch of moral science that deals with how and what a
professional should or should not to do in the workplace
 It address the question “What should I do in this situation?”
 Intended to bind professions more tightly together around a
shared standard values
 Knowledge on professional ethics can guide staff in
analyzing assumptions and arriving at ethical decisions
 OBJECTIVES OF PROFESSIONAL ETHICS
 Perform duties and responsibilities objectively in accordance
with relevant standards and guidelines
 Serve in a lawful and honest manner while maintaining high
standards of conduct and character and not engage in acts
discreditable to the profession.
 Maintain the privacy and confidentiality of information
obtained in the course study unless disclosure is required by
a legal authority. Such information shall not be used for
personal benefit or released to inappropriate parties.
 Maintain competency in their respective fields and agree to
undertake only those activities which one can reasonably
expect to complete with professional competence.
 Perform tasks with dull confidence, absolute reliability and
accuracy
 Be dedicated to the use of clinical laboratory science to
promote life and for the benefit of mankind
CODE OF ETHICS OF MEDICAL
TECHNOLOGIST IN THE PHILIPPINES
 AS I ENTER INTO THE PRACTICE OF MEDICAL TECHNOLOGY I
SHALL:
 Accept the responsibilities inherent to being a professional
 Avoid associating or being identified with any enterprise of
questionable character
 Work and act in a strict spirit of fairness to employer, clients,
contractors, employees and in a spirit of personal
helpfulness and fraternity toward other members of the
profession
 Use only honorable means of competition for professional
employment or services and shall refrain form unfairly
injuring, directly or indirectly, the professional reputation,
projects or business of a fellow medical technologist
 Accept employment from more than one employer only when
there is no conflict of interest
 Perform professional work in a manner that merits full
confidence and trust carried out with absolute reliability,
accuracy, fairness and honesty
 Review the professional work of other medical technologists,
when requested, fairly and in confidence whether they are
subordinates or employees, authors of proposals for grants
or contracts, authors of technical papers or other publications
or involved in litigation
  Advance the profession by exchanging general information
and experience with fellow medical technologists and other
professionals and by contributing to the work of professional
organizations
 Restrict my praises, criticisms, views and opinions within
constructive limits and shall not use the knowledge I know for
selfish ends
 Treat any information I acquired about individuals in the
course of my work as strictly confidential, and may be
divulged only to authorized persons or entities or with
consent of the individual when necessary
 Report any infractions of these principles of professional
conduct to the authorities responsible of enforcement of
applicable laws or regulations, or to the Ethics Committee of
the Philippine Association of Medical Technologists
 As may be appropriate to these principles, I hereby
subscribe and pledge to conduct myself at all times in a
manner befitting the dignity of my profession.

 MORAL PRINCIPLES
 Autonomy – Patient has the right to refuse or approve
treatment
 Beneficence – you have to do whats beneficial to patient
 Non-maleficence – you should do not harm patients
 Justice – fairness / equality
 Respect for dignity
 Truthfulness and Honesty – dedication of Medical
Technologist to work
 Stewardship - management or care of something, particularly
the kind that works.

 VALUES OF A MEDICAL TECHNOLOGIST

 Punctuality
 Integrity
 Commitment
 Honesty
 Loyalty