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Module 5 - Communication, Requisitioning

and Reporting
Site: New Era University
Course: MTLM21-18 - Laboratory Management
Book: Module 5 - Communication, Requisitioning and Reporting
Printed by: April Angela D. Pabello
Date: Monday, 20 December 2021, 12:25 PM
Table of contents
 1. Controlling & Evaluating (Communication)
o 1.1. Learning Outcomes
o 1.2. Lecture
o 1.3. Forums:
o 1.4. Assignment
 2. Requisition and Reporting
o 2.1. Learning Outcomes
o 2.2. Lecture
o 2.3. Forums
o 2.4. Assignment

1. Controlling & Evaluating (Communication)

 It is the final management function wherein leader can assess whether the desired
objective is achieved in accordance with their plan.
 The process of monitoring the standards, measurements and feedback mechanisms
that were set in place to ensure implementation of the management plan. The
process of looking back.
 Drucker has pointed out that there are two parts of giving instructions. The first part
is to be sure that the instructions are clearly understood; the second part is to check
to ensure that instructions have been followed. Consider the following scenario:

1. A manager gives the staff 10 tasks but the employees know that questions will be
asked about only two.

2. A teacher covers a topic completely, but the students do not expect the subject to
be on the exam.
  The control function is the measurement and feedback mechanism of setting
objectives. It completes the management function loop by comparing what has
actually been accomplished with the original master plan in order to determine its
success or identify needed modifications.
 The tools of persuasion and control are the primary mechanisms for success in
controlling function. Tools of persuasion focus on working with and through people
and tools of control involve the allocation of resources.
 Basic steps:

1. Formulate / review standards, objectives and methods.

2. Measure actual performance by observing, reviewing records etc.

3. Compare actual performance with the standards and objectives.

4. Taking actions to reinforce strength and take corrective actions.

1.1. Learning Outcomes

At the end of this module the students will be able to:

1. Define, compare and contrast the Controlling and Evaluating.
2. Differentiate the tools of persuasion and tools of control.
3. Describe the Elements of Control.
4. Enumerate and explain the Performance Appraisal Tools.
5. Define Communication Process.
6. Explain the Elements of Communication Process.
7. Differentiate the Verbal and non-verbal Communication
8. Explain the Barriers and Improving of Communication Process.
9. Discuss the types of Laboratory Communication
1.2. Lecture

Controlling / Evaluating

 It is the final management function wherein leader can assess whether the desired
objective is achieved in accordance with their plan.
 The process of monitoring the standards, measurements and feedback mechanisms
that were set in place to ensure implementation of the management plan. The
process of looking back.

Elements of Control
1. Standard – the desired result.
2. Comparison of actual result with the desired result.
3. Corrective actions if needed.
Development/Determination of Standards

• Is established by an authority, consummated and accepted by the standards.

• Is a predetermined feel of excellence that serves as a guide to practice

Performance Appraisal Tools/ Measurement of Performance

1. Trait Rating Scale – a method of rating person against a set of standards which may be
the job description, desired behavior and personal traits.
2. Job Dimension Scale – a method of rating that focused in job requirements then quality
of work.
3. Behaviorally Anchored Rating Scale – a method of rating that focused on the desired
behavior to improve performance.
4. Checklist – a method of rating composed of behavioral statements that represents a
desirable behavior.
5. Peer review – a method of rating that focused on the total situation of the performance to
promote excellence in practice and offer information, support, guidance, criticism and
direction to one another.
6. Self appraisal – a method of rating where employees evaluates its own performance.

Communication Process

 is the exchange of information between at least two persons

 the act or process of receiving and transmitting messages.

Elements of Communication:

 Sender: person wishing to transmit a message

 Message: the actual format of the communication effort, including verbal and non
verbal signals, symbols and language transmitted.
 Mode of Transmission: the vehicle by which a message is sent; oral, written, non
verbal, recorded or third party.
 Receiver: the target of the message; either an individual or group
 Decoding: How a receiver translate the message.

Types of Communication
1. Verbal – refers to spoken words.
2. Non verbal – refers to written, laboratory result

Barriers to Communication:

1.Structural – distance, spatial constraints

 Action: remove or find alternative routes.
2. Semantics – words and messages, symbolism, figures, penmanship.
Action: Pay attention to both content and context of message
3. Technical – noise, distracting activity, lost message, information overload
Action: Find alternative routes or times
4. People – moods, emotions, feeling, halo effect, perception problems, interpersonal
factors (social and personal differences)
Action: provide training, groundwork, feedback, explanations, reassurance, trust,
and credibility.
5. Outcome – failure / low acceptance of the message.
Action: ensure that the outcome is within the ability of the receiver to perform.

Improving the Communication Process:

1. Good Listening – asking questions, seeking feedback, showing interest in the speaker
and subject, looking for clues and signals.
2. Empathy – allows the sender to prepare the message with the needs of the audience in
mind, with concern and interest.
3. Repetition – sending message through several different routes; familiarity.
4. Presence of understanding – elements of communication (sender, receiver, message)
5. Process of Mutuality – eye contact, sound of voice and body language.
6. Composure – ability to compose one self (poise)

COMMUNICATIONS & DATA PROCESSING

 Communications, both written and verbal, are a major component of all medical
care. The essence of Laboratory Medicine or Clinical Pathology is the acquisition of
data by analytical procedures performed on the patient specimens , the
determination of the validity of those data with appropriate interpretation to the
patient’s physician to assist the physician in diagnosis, therapeutic and prognostic
decisions.

TYPES OF LABORATORY COMMUNICATION

INTRALABORATORY COMMUNICATIONS

1. Policy Manual

 State the laboratory and institutional policy for guidance of those working in the
laboratory.
 The policy should reflect the philosophy and overall goals of the larger organization
as well as those of the laboratory.
 Written in consultation with the persons involved by the appropriate persons and the
institutions. It should be consistent on the institutional policy. It should be also
updated and approved by laboratory director.
 It refers to topics that may have particular relevance to area:
Dress code, Food and Smoking rules; Telephone uses; Lab organizations and
reporting relationship; writing, review and authorization of procedures; vacation and
 holiday requests; supply requisition; ATU; Reporting and releasing of test results;
specific statements about enforcements of safety rules.

2. Procedural Manual

 Quality control systems for laboratories should be designed to assure the medical
reliability of the laboratory data.
 All laboratory methods in current use must be recorded in notebooks, card, files, or
sets of flow charts available at all times in the immediate bench area where the tests
are performed .
 Each method description must be complete, including reagent brands, source and
content of standards, calibration procedures or special precautions, anticipated
reactions and pertinent literature references.
 Each method must be dated and initiated by the head or responsible supervisor,
initially or at least annually. Referred to as SOP, term adopted from military meaning
“standard operating.”
 Technical manuals that contain procedure for performing tests, operating
instruments, or processing quality control information are examples of procedural
manuals found in the laboratory.

3. Other Internal Manuals

 Administrative Manuals
 Safety Manuals
 Quality Management Manuals

4. Continuing in-service education

 Because of rapidly changing nature of laboratory medicine, it is also desirable to

have regular continuing education sessions for laboratory staff.

5. Intralaboratory Staff Meetings

EXTRALABORATORY COMMUNICATIONS
1. Manual of procedures and Collection Instructions

 Laboratory must maintain a complete detailed book of instructions covering the

ordering the tests, precautions or special procedures, the proper method for
preservation of specimens and pertinent standard procedures of the laboratory.
 Procedures used for collection of all specimens, and pertinent standard procedures,
identification, storage and the preservation must be clearly described in writing and
available to those collecting specimens.
 All procedures shall be such as to insure satisfactory specimens for procedures to
be performed.
 Example: Specimen Collection Manual
A manual or section of the laboratory service manual that contain detailed
instructions for patients and health care providers.
2. Laboratory User’s Manual

 This is particular useful in teaching institutions where there is a large and frequently
changing group of attending physicians, house officers and students who need ready
access to information about laboratory services. A user’s manual of two sections has
been found to be useful.

a. The first section contains a directory of the laboratory sessions (Hematology,

Chemistry) with listings of the key staff, the laboratory section, telephone numbers,
operating hours and special instructions.
b. The second half of the manual consists of the alphabetical computer listing of
laboratory measurements and examinations

 Example: Laboratory Service manual

A manual designed for users of the laboratory; covers policies and procedures
concerning operational factors such as business hour, services provided, specimen
submission requirements and billing practices.

3. Laboratory Bulletins

 Periodic laboratory bulletins, newsletters or measurements of the month, circulated

to the medical staff, ae useful means of communicating information abut new
laboratory service or policies. These are generally most effective when a standard
format has been devised and when they are issued on a regular basis.

4. Other Extra laboratory Communications

 Laboratory Directors to be available and responsive to written and verbal

communications form the clinicians users of the laboratory.
 Perception of the laboratory manager or staff towards the criticism of the external
environment.

1.3. Forums:
FORUMS:
Answer the following questions by clicking the forums below:

FORUM 1 FORUM 3

FORUM 2 FORUM 4

1.4. Assignment

1. Download and answer the

worksheet: https://college.neu.edu.ph/mod/assign/view.php?id=128883
2. Answer the worksheet using Adobe Acrobat Reader PDF Fill and Sign
Feature OR you may download and print the worksheet, answer the questions in
black ink then scan and save to PDF OR you may copy and paste it to the
Microsoft Word to answer the questions the save it to PDF.
 3. Submit your work by uploading your assignment here in NEUVLE by following the
instructions indicated on this
link: https://college.neu.edu.ph/pluginfile.php/185133/mod_resource/content/1/HOW
%20TO%20SUBMIT%20ASSIGNMENT%20IN%20A%20COURSE.pdf

2. Requisition and Reporting

After the proper communication in the clinical laboratory was established and written on
their policy, it is also important the we know the criteria of specimen acceptance and
rejection most particularly in Patient/Client Information to ensure the reliability of your
results.

2.1. Learning Outcomes

At the end of this lesson the students will be able to:

1. Discuss the scopes of Requisition and Reporting.
2. Enumerate the patient information essential when receiving different types of specimen.
3. Differentiate Verbal and Written Reports.
4. Identify the alternatives for Verbal Reports
5. Apply the concepts of patient identification prior specimen collection and receiving.
6. Review the Laboratory Information Systems and its components
7. Enumerate the computer networks.

2.2. Lecture

REQUISITIONING

 It assures adequate identification of the patient and specimen, indicate the

measurements for examinations desired. An additional important function is the
provision of administrative and billing data.
 All request for Clinical Laboratory test must be made in writing. Proper recording or
time stamp is important aspect in the clinical laboratory for the date and time of
receipt of specimen. Minimum identification data shall include the following:

1. Full name of the patient

2. Hospital number (name of ward ex. Medical, surgical)
3. Room number, bed number
4. Age / sex
5. Attending Physician
6. Birthdate
7. Date

 It should clearly specify the tests to be performed and kind of the service required
(Stat, Routine). The time of collection should also be indicated.
  Record book should be maintained for the daily accession of the specimen, each
would be numbered, or otherwise appropriately identified. The record should contain
at lest following information.

1. Accession number
2. Hospital number
3. Name of the patient
4. Date and time the specimen was collected
5. Date and time the specimen was received
6. Date, time and by whom the specimen was examined
7. Condition of any unsatisfactory specimen
8. Type of test or procedure performed
9. Clinical diagnosis
10. Results and date of reporting
REPORTS

1. Written reports

 Laboratory head is responsible for all laboratory reports and that authenticated dated
reports of clinical pathology test should be filed promptly with the patient’s record
and duplicated copies kept in the laboratory.
 Each report should be time stamped to record the date and hour the procedure was
completed. Each request and report should identify the patient with certainty,
whenever feasible reports should all be signed or initialed by Medical Technologist
responsible for performing the procedure or by the pathologist.
 General qualities of a Laboratory Report

a. Compactness
b. Consistency of terminology, format and usage and under stability
c. Clear and easy to understand
d. Logical and accessible location in medical chart
e. Statement of date and time of collection
f. Gross description and source of specimen when pertinent
g. Sharp differentiation of reference or normal and abnormal values.
h. Sequential order of multiple results on single specimen
i. Identification of patient, patient location and physician
j. Assurance of accuracy if transcription of request.
2. Verbal Reports

 It constitute a major problem for most laboratories. It is essential that verbal or

telephone communication must be given in order to facilitate medical care,
particularly in an emergency situation. On the other hand, this is major potential
source of errors and medical liability.
 A minimum, the laboratory should require proper identification of the person
receiving the report. The person giving the report should repeat the patient’s name,
identification number and location along with the results in order to further confirm
the identification.
Alternative Methods to Verbal Reports

 Hand written results on either blank or pre printed form - it has the advantage of
reliable and relatively inexpensive, but it is subjected to error.

 Facsimile transmission, a process similar to photocopying a document, but done

electronically to a remote output device - giving an exact facsimile of the original test
report but has the disadvantage of being more expensive, generally slower in some
cases less reliable.
 A permanent report from the laboratory in the usual format would follow for medico-
legal and medical record purposes:

1. Patient identification, usually in the upper right hand corner. Provisions should be made
for either hand written or printed information.
2. The date and time of specimen collection and identification of the person who collected
the specimen.
3. The measurement or examination requested. When the same requisition is to be used for
reporting, appropriate space for the results should be included.
4. Date and time of reporting and the initials of medtech performing the determination.
5. The identification of the laboratory. It is also desirable to have imprinted on the form, the
name of head of the laboratory and/or associate Pathologist of the laboratory section in
which the requisitions is used.

PATIENT and SPECIMEN IDENTIFICATION

 This is one of the problem in the clinical laboratories. Reliable patient and specimen
misidentification is an essential feature of any accurate laboratory testing and
reporting system.
 Identification system being used in the clinical laboratory should be the same as that
is being used for admitting, nursing, pharmacy, radiology, and other services.
 Let the patient state his/her full name and date of birth.
 In case of in-patient, countercheck the patients information on the wristband while
stating his/her information then against the request.
 For special cases, such as unconscious or child, ask the immediate relative or nurse
on duty for the proper identification.
 Verify the completeness of the patient’s date on the request form.
 Any discrepancy from the test request form; actual information; and, encoded on the
laboratory information system shall ask the nurses on the accuracy of result. If
possible, let the nurses and/or relative to sign a waiver as a proof that the clinical
laboratory staff shall not reliable on the error of the patient’s identification.
 Proper labeling of tubes and specimen container is important:

a. Complete name (last name, first name, middle name)

b. Age and Sex (sex at birth)
c. Birth date
d. Date and Time of extraction
e. Name and initials of phlebotomist.

LABORATORY INFORMATION SYSTEM (LIS)

 A complete network of computer components designed to incorporate all aspects of

the informational needs of the laboratory and its customers form the intake of
requests for services and the processing of work flow to the deliver of results.

TERMINOLOGY:

 DATA – raw elements or single facts that by themselves have no meaning but when
organized and evaluated together have the potential to reveal information.
 Information – data have been processed, sorted and presented in such a manner
that in increases the knowledge of the user
 Information System – collection of interlinked and dependent parts that are
organized to collect and input data, process the data into information, output of the
information, to users to provide feedback to the system with the goal of meeting the
complete informational needs of the organizations.

COMPONENTS:

1. HARDWARE – the physical (plastic, wire) parts of computer.

a. Central Processing Unit – electronic portion of the computer; includes controlling unit
and the quantitative analysis and data processing unit.
b. Input devices – include keyboards, bar code readers, computer links.
c. Output devices – include printers and screens to disseminate information
d. Computer memory and data storage.
e. Data Storage devices
2 .SOFTWARE – the instructions (program) given to the computer to perform its tasks.
a. Application software – program designed to meet specific needs of the users, such as
word processing, pay roll, blood bank inventory management.
b. System Software – programs designed to control and run operating systems of the
computer including communications, application software and database management
COMPUTER NETWORKS
1. Local Area Network (LAN) – a computer network that connects computers and their
equipment in a confined area, usually a building or a place in which the users are in close
geographic proximity to each other.
2. Wide Are Network (WAN) – a computer network that connects computers and their
equipment over a large disbursed geographical area such as state, nation or the whole
world, usually through the facilities or common carriers such as telephone lines or satellite
channels.
a. Host based Lab Information Systems (LIS) – LAN interfaced with central controlling
CPU whose program determines hoe data are received, processed and disseminated.
b. Client server LIS – an open system that allows users to tap into the LIS with their
independent computer systems, extract only the information they want, and present it in
formal they wish on their own computer screen or printer.

2.3. Forums

FORUMS: Answer the questions below by clicking the links.

FORUM 1

FORUM 2

FORUM 3

2.4. Assignment

1. Download and answer the

worksheet: https://college.neu.edu.ph/mod/assign/view.php?id=128887&forceview=1
 2. Answer the worksheet using Adobe Acrobat Reader PDF Fill and Sign
Feature OR you may download and print the worksheet, answer the questions in
black ink then scan and save to PDF OR you may copy and paste it to the
Microsoft Word to answer the questions the save it to PDF.
3. Submit your work by uploading your assignment here in NEUVLE by following the
instructions indicated on this
link: https://college.neu.edu.ph/pluginfile.php/185133/mod_resource/content/1/HOW
%20TO%20SUBMIT%20ASSIGNMENT%20IN%20A%20COURSE.pdf

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Module 6 - Personnel & Material

Management
Site: New Era University
Course: MTLM21-18 - Laboratory Management
Book: Module 6 - Personnel & Material Management
Printed by: April Angela D. Pabello
Date: Monday, 20 December 2021, 12:26 PM
Table of contents
 1. Personnel Managment
o 1.1. Learning Outcomes
o 1.2. Lecture
o 1.3. Forums
o 1.4. Assignment
 2. Material Management
o 2.1. Lesson Intended Learning Outcomes
o 2.2. Lecture
o 2.3. Forums
o 2.4. Assignment

1. Personnel Managment
The responsible laboratory head should be concerned in the development of human
resource to its optimal level, as management has been defined as “getting things done
through the efforts of other people.” this requires an understanding of those factors affecting
motivation and those techniques available for personnel management.

1.1. Learning Outcomes

At the ends of this modules the students will be able to:
1. Define Personnel Management.
2. Understand the concept of motivation.
3. Enumerate and apply the behaviors of the good leader.
4. Enumerate, compare and contrast the theories of motivation.
5. Discuss the selection process.
a. Needs Assessment
b. Requirement and Selection of Employees
c. Position Classification
d. Orientation
e. In Service Continuing Education
f. Staff meetings
g. Personnel Records
h. Discipline and Dismissal
1.2. Lecture

PERSONNEL MANAGEMENT

 The responsible laboratory head should be concerned in the development of human

resource to its optimal level, as management has been defined as “getting things
done through the efforts of other people.” this requires an understanding of those
factors affecting motivation and those techniques available for personnel
management.

MOTIVATION

 The day-to-day operation of the laboratory and the motivation of the persons in the
laboratory will determined to a large extent by the management style of those
responsible for directing the institution, the laboratory, and various laboratory
sections.
 Management styles are determined by a person’s personality and previous
experience, but can modified if a conscious effort is made.

BEHAVIORS THAT MAKE A GOOD LEADER

 The concept of MOTIVATION is imperative at this time. This incorporates the idea of
incentives, purpose, motives, and the drive. By identifying and understanding the
motives and reason why people work and what they are looking for in a job will lead
to the development of a plan that matches the motivational goals of individual and
those the organization.
 ATTITUDE – is a person’s outward disposition toward his or her job and co-workers.
The primary goal of manger is to help the staff develop and maintain positive
attitudes toward the laboratory and its mission.

THEORIES OF MOTIVATION

 Current understanding of the influence of leadership and management has been

derived form the work of a number of persons particularly Mc Gregor, Herzberg, and
 Maslow develop a theory of human motivation based on the fact that man is a
wanting animal, that is his behavior is determined by unsatisfied needs and arranged
them in hierarchy of importance from the most fundamental to the ones providing the
most satisfaction.
 These are as follows:

1. Maslow’s Theory – Maslow’s hierarchy of needs theory prioritized human needs into five
categories namely physiologic, safety, social, self-esteem and self-actualization.
a. Physiologic d. Self-esteem
b. Safety and security e. Self-actualization
c. Belongingness

2. Herzberg’s Theory – cites importance of needs satisfaction and proposes that some
work place or job related factors can generate dissatisfaction in the employees whereas
others offer promise as motivators. He suggested the following motivators as an integral
part of job:
a. Achievement – feeling of making difference and having sense of contribution and
accomplishment.
b. Recognition – for one’s roles in the success of the group.
c. Challenging – work that reinforces employee’s conflict.
d. Responsibility – feeling that one is in control of one’s future.
e. Professional Advancement / Professional Growth - chance for advancement.
3. Mc Gregor’s Theory – described the two extreme management style.
a. Theory X Style – still exists in any medical care settings. Little delegation of authority
and sharing responsibility. Management style based on the assumption that people hate
work; that they have to be driven, threatened and punished to achieved organizational goals
(such as good patient care) and they lack ambition and want only security.
b. Theory Y Style – Authority and sharing responsibility. Theory based on the following
assumptions:

1. People don’t have to be forced or threatened to work

2. Work is considered as natural as rest or play
3. They will commit themselves to external organization only to the extent that they see
ways of satisfying their own internal ego and development needs.
c. Theory Z Style – theory is relationship oriented; democratic leadership style;
participative management, shared authority, responsibility and accountability.

4. Mc Clelland’s Achievement Model – ties the strength of behavioral motives to the

individual’s assessment of likelihood of achieving a specific goal. This further proposes that
even though that there are definite needs that provide explanation for behavior, the strength
of a specific motive is directly linked to the opportunities offered by situation. This theory
needs the following work related needs:
a. Achievement needs - job and career success (self-actualization)
b. Power needs – control and influence
c. Affiliation needs - warm, family relationships.
5. Alderfer’s Theory - ERG Needs Theory
E – xistence needs; physiologic needs.
R – elatedness needs; interpersonal relationships, acceptance and belonging
G – rowth needs; creativity, challenge and personal growth on the job

6. VROOM’S EXPECTANCY THEORY

 This is process of making choices in direct response to the expected potential for
rewards. This motivational theory holds that:
a. Effort will bring rewards.
b. The effort expended will be related to the perceived value of the reward to the
person.
The following variables influences the selection decision:
1. Expectancy – the belief that effort brings performance and performance leads to
rewards.
2. Outcome – the perceived expectancy that the outcome from the effort (reward)
will actually be realized.
3. Instrumentality – the degree of faith in the belief that current efforts may make
possible achieving even larger or more long-term rewards.

7. ADAM’S EQUITY THEORY. Propounded by J. Stacy Adams. This theory holds that
employees are motivated by the degree of equity that they perceived in their work situation,
especially compared with people in similar positions. Key concepts include comparison and
perception.

8. SKINNER’S REINFORCEMENT THEORY – based on the observation that we tend to

behave according to the way we are treated. This focuses on the environment rather than
on needs, motives, and personality as an explanation of behavior. Example: wage is directly
proportional to performance evaluation.
Components:

a. Law of Effect (E.L. Thorndike) – states that we act in response to expected

consequence. Example: provide pleasures-recur; discomfort-avoided.
b. Stimulus – an event that leads or influences to a response.
c. Response – behavior that results from a stimulus.
d. Reinforcement - consequence of an action or response.
e. Behavior motivation – the application or practice of reinforcement.

PERSONNEL SELECTION PROCESS

Needs Assessment

Why do we need new personnel?

 Employee’s resignation and departure.

 Increase in workload or a change on the work process that requires recruitment of a
person with special skills and training.
  Remember: the manager must specify the type of person required and justify the
need and obtain authorization to fill the position.

Requirement and Selection of Employees

 It is the one of the most critical management tasks performed in the laboratory, since
each personnel added to the staff influences positively or negatively the future of the
laboratory.
 First step in the selection process is INITIAL SCREENING. The minimum criteria
used to define job positions are:

1. Minimum education
2. Work Experiences
3. Licensure Examination
4. Other qualifications

 For supervisory position, these criteria may be qualitative and these are as follows:

1. Communication skills
2. Problem solving attitude
3. Creativity
4. Innovation
5. Technical expertise in a clinical laboratory

Interview Strategy

1. Structured – formal and list of questions, standardized checklist, interview form.

2. Unstructured – band agenda, free to discuss any issues, allows spontaneity.
3. Stress interview – expose to dangerous, intimidating situation (police officers), problem
solving session (job related problem).

Interview Process

1. Preparation – review information (job description) and data submitted (resume

preferences).
2. Establishing rapport – make him relaxed and comfortable.
3. Questioning and information exchange – obtain information
4. Listening – assumes understanding, clarifies intent, demonstrate interest.
5. Cleansing and Follow-up – brief review to clarify information. Opportunity to ask
questions.
6. Evaluations – check list, fill-up form, impression, recommendation
Recruitment

 It is the process of locating and attracting qualified job applicants.

 It is the searching stage, designed to build a pool of candidates from which to select
the person suited to fill the position. The objective of recruitment process is highly
dependent on the conditions of the labor market.
a. Tight labor market
b. Open Labor market

 Sources of Recruits – those who are already known to the manager or human
resources department, either personal knowledge or because their applications are
on file; and candidates campaign.
 Inside sources – employees that are change in duties, focus on identifying persons
who want to improve their positions. Candidates may acquire new skills and jobs
through in-house, on-the-job training programs or by obtaining a promotion.
 Inside sources – the database of employees seeking lateral and vertical moves
should be available from the performance appraisal systems and the
employee development programs, in which the attributes and aspirations of an
employee have been identified and become part of individual’s and organization’s
long term plans.
 Inside sources – in addition, inside candidates may be found through:

a. Personnel records such as application files and transfer requests.

b. Job positioning and bidding, whereby current employees are notified of in-house
opportunities.

c. Recall from layoff

d. Promote from within policies.

 Inside sources – most institutions prefer to promotes from within because it rewards
dedicated and deserving employees and demonstrates an organizational
commitment to staff development. It can also boost morale. Other advantages in
promoting from within are as follows:

a. Continuity in administration and services is ensured, particularly if the company

likes the way things were done by the previous manager.

b. Current employees may have already shown their loyalty and long-term
commitment.

c. The company takes advantage of its investment in the individual.

d. Minimal orientation and training time and expenses are needed because the
employee is already familiar with operations and culture.

 Outside Recruitment – there are reasons and advantages to looking outside the
organizations as well some more legitimate than others:

a. Acquisition of new skills, knowledge and expertise

b. Need for improvement in performance; that is management is unhappy with the

way things are going.
 c. No suitable in-house candidate.

d. Low morale, group dissension or rivalry.

e. A worthy candidate who deserves a chance may be somewhere else in a large

corporation.

f. First time managers have high failure rate (80% of new supervisors fall in their first
management situation because of lack of training and commitment by the
organization.

Position Classification

 A method for position classification has been developed. This involves determining
the different kinds or classes of positions existing in the institutions.
 Each class is consists of all positions regardless of departmental location that are
sufficiently alike in duties and responsibilities to the descriptive title, to have the pay
scale and to require substantially the same quantification.
 Within its class, such as Medical Technologist I, Chief Medical Technologist or
Senior Medical Technologist, a number of pay steps are established. This provides a
means to compensate the experienced employee at job entry.


Job positions:
1. Director – a physician or holder of bachelor’s degree or higher in a science discipline with
corresponding experience.
2. Technical consultant – same as Director’s qualification
3. Technical supervisor – same as technical consultant qualification.
4. Clinical consultant – a physician or a Doctoral level scientist.
5. General supervisor – a laboratorian with an associate degree or higher in a medical
laboratory science / medical technology and two years of training and experience in a high
complex laboratory.
6. Testing personnel – a person performing tests in a high complex laboratory. Must have at
least an associated degree.

Orientation

 Formal introduction of new employees to the organization and their duties.

 Orientation program is one of the most overlooked tools available to the manager.
 Each laboratory shall have their own program of orientation for new employees.
Even though a new employee is a registered medical technologist, but his
experiences with a particular procedures in use in a new environment may be
limited.
 During this orientation it should be emphasized that suggestions for changing
procedures or methods are welcome and will be given due consideration, but each
employee must follow the laboratory method and procedure exactly is prescribed.
  If done correctly, orientation can establish early in the employee’s career an
understanding of the philosophy of the laboratory and the institution.
 It can correct those misunderstandings that are so often present with employees and
can establish in the beginning an open channel of communication between the
supervisor and the new employees.
 The following is a minimum list of items that should covered in the orientation:

1. Job description duties and responsibilities.

2. Overall objectives of the laboratory and employee’s role.

3. Employee evaluation form and how it is used.

4. The departmental organization and the “key personnel.”

5. The location of the procedure manuals and their contents.

6. Time records and they are handled.

7. Laboratory policies relative to meal time breaks, Service incentive leave, off and
holiday scheduling.

8. Employee’s role in fire and disaster plans.

9. Employee’s priveledges.

10. Schedule of duties (regular, night and special)

Human Resource Administration and Supervision

 Orientation is only the start of relationship between the individual and the
organization. This activity is referred to as human resource management and consist
of the following components:

1.Wage and Salary Administration

2.Staffing and Scheduling

 The supervisor and the personnel department have the responsibility to ensure the
well being of this association and the productivity and coherence of the workforce.

1. Wage and Salary Administration

 Compensation is the most visible aspect of the personnel process. Both the
institution and the employee are reminded of this fact every payday. The goals and
objectives of the wage and salary administration program include:
a. Recruiting a highly skilled and qualified staff.
b. Maintaining a sable workforce.
c. Maximizing productivity through incentive plans that reward desired behavior.
d. Controlling labor costs.
e. Complying with legal regulations
f. Meeting social and cultural expectations and goals.

 Total compensation package consists of three elements:

a. Paycheck – represent the amount of money the employee can take home.
b. Benefit package – important part of total compensation package and are supplements to
the cash payment of salary and wages.
1. Medical, disability and life insurance

2. Retirement plans including contributions from both employer and employee.

3. Paid time off for sickness, vacations, holidays and continuing education
4. Tuition reimbursement

c. Perquisites (perks) – they are also given part of total compensation package. It includes
job title, private secretaries, use of company car, offices with new attractive furniture, a
personalized parking place and even country club membership.

 Minimum wage rate – currently set at 360 per day; some require a higher rate
 Overtime pay – this includes the following:

a. 40-hour rule – wage and hour laws that require employers to pay overtime to employees
who work more than 40 hours in a 7-day calendar period.
b. 8/80 hour rule – a special provision to the wage and hour law that allows health care
employees to work extended periods of time outside the 40-hour rule and set overtime pay
when they exceed 80 hour in a 2 week calendar period or work more than 8 hours in a
single day.

 JOB EVALUATION – Worth of a job. It is one tool used to determine the relatives
worth of jobs. The four most common methods for conducting a job evaluating are as
follows:

c. Point System – this method is the most popular because it attempts to consider all the
components of a job in comparing one job to another. The typical model allocates points to
four broad groups of factors: skill, effort, responsibility and working conditions.
d. Factor comparisons – this method focuses on determining the relative worth of a job by
comparing it to other jobs in the organization on scale that assigns a monetary value to
each factor and is then totaled to give the wage rate for a specific job.
 Factor comparisons:

2. Staffing and Scheduling

Staffing is the setting of long- term goals and objectives for the umber and types of
personnel needed to meet the labor requirements of the laboratory. This includes types of
personnel needed, staffing levels and performance training and workload projections.

Steps in the Staffing Processes:

a. Determine the number and type of personnel needed.
b. Recruiting
c. Interview
d. Induction/orientation
e. Hiring – pre employment testing, physical exam (mandatory), selection/placement and
evaluate for permanent position

 An important part of employee development is feedback, whether negative or

positive. This can be accomplished thorough random meeting, memorandum to the
full or through a structured evaluation system.
 The latter offers the opportunity for the employee and supervisors to take time to
review past performance, as well as to project future expectations. It provides the
framework within which constructive criticism can be given and provides the vehicle
by which relationships can be refined.
 For fairness and uniformity, the format should be used for all employees.
 The most frequently measured areas are the following:

1. Adaptability – ability to change the behavior, attitude and work methods to meet
demands of the situation.
2. Attendance – faithfulness in coming to work and conforming the assigned job duties.
3. Quality of Work – accuracy thoroughness and precision of work performed.
4. Job Knowledge and skills – the employee’s of his training and experience in performing
the assigned job duties.
5. Quantity of Work – amount of work performed in comparison with normal amount
expected.
6. Work relationships – Quality of relationships with coworkers, supervisory staff, patients
and the public.
7. Initiative – extra effort.
8. Responsiveness – how quickly an individual accomplishes an assignment.

In Service Continuing Education

 It is desirable to have a regular continuing education session for laboratory staff.

 Laboratory staff can develop this, and the head of the laboratory with outside
participants are needed.
 The staff should be given time and encouraged to attend, appropriate medical staff
meetings in the institution as well as continuing education programs in the laboratory
medicine elsewhere.
 Documentation of attendance at such meetings, as well as topics covered should be
maintained to meet accreditation requirements.

Staff Meetings

 Intralaboratory communications – enhanced and crisis minimized regularly

scheduled meetings of laboratory heads, associates, supervisors, and staff held.
 Meeting of the supervisor and the head should held weekly to discuss administrative,
professional and technical problems.
 The meeting is also a forum to discuss problems, new policies, and procedures, and
for planning. Such teamwork in the laboratory and to bring problems to light before
they become crisis.

Personnel Records

 All institutions maintain some personnel records on employees, but the laboratory
may wish to keep a duplicate set of records for their use.
 If so, consideration should be give to what information should be, and legally can be
kept in these records.

Discipline and Dismissal

 Some employees will fall short of expected standards. When the situation arises,
decisive action is imperative. No action is not acceptable approach how much to
take will depend upon the type of infraction and the circumstances surrounding it.
 Examples of failure of performance of duties req. disciplinary actions

1.Incompetence
2.Negligence
3.Physical or mental incapacity
4.Habitual and improper use of SILs.
5.Failure to maintain satisfactory and harmonious relationship

 All of these have in common the failure of the employees to meet standards related
to the quality of work.
  When a disciplinary action becomes necessary because of failure of performance of
duties, the following steps are usually considered essential. Following steps are
considered essentials:

1. Oral warning
2. Second oral warning with letter
3. Written formal warning
4. Notice of dismissal

 Some examples of job-related personnel conduct requiring disciplinary action:

1. Conviction of felony
2. Willful damage, destruction or theft of property
3. Falsified job information to secure a position
4. Possession of unauthorized firearms or lethal weapons on the job.
5. Insubordination
6. Reporting to work under the influence of alcohol or non-prescribed drugs, or partaking of
such on job.

1.3. Forums

FORUMS:
Answer the following questions by clicking the links below.

FORUM 1

FORUM 2

FORUM 3
1.4. Assignment

 Download and answer the worksheet: Assignment in Personnel Management

 Answer the worksheet using Adobe Acrobat Reader PDF Fill and Sign Feature OR you
may download and print the worksheet, answer the questions in black ink then scan and
save to PDF OR you may copy and paste it to the Microsoft Word to answer the
questions the save it to PDF.

 Submit your work by uploading your assignment here in NEUVLE by following the
instructions indicated on this
link: https://college.neu.edu.ph/pluginfile.php/185133/mod_resource/content/1/HOW%20TO
%20SUBMIT%20ASSIGNMENT%20IN%20A%20COURSE.pdf

2. Material Management
 It is the systematic process of overseeing and controlling the acquisition and
utilization of supplied to ensure both availability and cost effectiveness.
 This function consists of the purchasing and requisitioning of supplies and the
oversight of products after they arrive.
 At hospital level, these two functions are handled by a centralized material
management department organized into two sections: purchasing and stockroom.
 Purchasing section oversees the ordering of supplies and the processing of the
invoices from vendors.
 Stockroom maintains security and inventory level and issues supplies throughout the
facility.

2.1. Lesson Intended Learning Outcomes

At the end of this lesson the student will be able to:

1. Define the Material Management.
2. Discuss the Principles of Purchasing and understand the purchasing process.
3. Understand the Products Research and Specifications.
4. Enumerate the considerations on purchasing supplies.
5. Discuss the Receiving and Accounts Payable.
6. Apply and understand the basic concepts of Records and Inventory control.
7. Discuss the Stock Replenishment Technique and Financial Control Inventory.

2.2. Lecture

The Materials Management System can be used to manage functions like purchasing,
accounting, inventory management, and patient supply charges (Materials Management
Systems, 1996)

PURCHASING

 Clinical laboratories require a raw materials for successful operation. Whereas,

equipment idled by breakdowns of lack of supplies is an economic less for business,
the same situation in the clinical laboratory can seriously interfere with the delivery of
patient care.
 Laboratory staff shall maintain their inventories and identify what they need, when
they need and how much they need.
 In large hospitals /medical center/health care institutions , the purchasing process
involves many people and elaborate systems for obtaining bids, for quantity buying.
In contrast, in the physician’s office laboratory, the medtech dealing directly with the
company’s representatives may handle the entire process.
Product Research and Specifications

 In order to determine the best products for laboratory use, time must spend on
product research leading to the development of product specifications.
 This can be done also by comparative evaluations within the laboratory, by
consultation with other users or by referenced to publications offering comparative
studies of equipment and supplies
 Similar process of evaluation and product specification is necessary prior to
purchase of major equipment. The following consideration are important.

1. Written specification – detailed descriptions of required equipment

2. On site visits – to see equipment operating in other laboratories.
3. An environment necessary to accommodate the equipment
4. Complicated decision is whether to buy major equipment
5. Complete instruction and preventive maintenance manuals
6. Newly acquired instruments in the laboratory must be reported in Health Facilities and
Services Regulatory Bureau (HFSRB-DOH)
Purchasing of Supplies

 For budgeting purposes, products that meet specific time and price criteria are
classified as supplies. Items that fall outside the criteria are classified as capital
items. Moreover, supplies may be classified as:

a. Items that are consumed within 1 year or have a shelf life of less than 1 year.
b. Items below a certain price level, as established by the controller even though their shelf
life exceeds 1 year.

 Following considerations in purchasing supplies:

1. Only authorized staff members who are familiar with the quality of service and reliability
of supplies should place orders.
2. Delivery schedules are a major factor in determining whether a purchasing system in in
or out of control
3. High use items should be delivered frequently.
4. Excellent methods of doing this and can save the laboratory time and money is through
the purchase orders.

 Purchase order – document authorizing the purchase of a product or service from

vendor.
 Release orders – contracts in which company agrees to deliver goods at a
predetermined prices as notified by the laboratory.
 Standing order - annual contract in which the company agree to deliver goods at a
predetermined price and on an established schedule.

Receiving and Accounts Payable

  Goods should unpacked and inspected as soon as possible to ensure that every
things is delivered or that some acknowledgement of back ordered is made.
 Damaged or defective goods should identified early in order to assure replacement
credit.
 Three pieces of information must agree before the company’s bill will be paid by the
most accounts payable systems.

1.The purchase request must agree with the invoice.

2.The invoice must agree with the packing slip.
3.They must all agree with the final bill from the company.

 Any non-payment between the figures results in payment to the company being
withheld.

Records and Inventory Control

 Inventory management is a continual process of checking stock levels, rotating stock

to ensure freshness or ordering supplies in sufficient quantities to meet current
needs, and minimizing the cost of carrying order inventory. Inventory check is
performed at least once a year. There are three methods of track inventory levels
namely:

1. Perpetual system – keep account of the inventory each time a product is used.
2. Periodic system – is more common at the bench department level.
3. Random checks – such as the annual inventory are used to document the value of
supplies at a specific time,
Inventory levels are set at low and high points:

1. The low level is a point on which on hand supplies are sufficient to carry the laboratory
through until goods are received.
2. The upper limit is that level which will meet the laboratories requirements for a longer
period of time, such as several months or a year.
The primary factors determining the said limits

1. Anticipated delivery time for each items.

2. Available storage space.
3. The shelf life of an item.
4. The anticipated rate of usage.
Stock Replenishment Technique

 Two techniques are available for determining how and when to replenish stock:
minimum-maximum and just in time replenishment strategies.

1. Minimum-Maximum. Determining when and how much to reorder is to establish a set

point (minimum) at which inventory is to be recorded and a “reorder to” (maximum) level to
be maintained.
2. Just in-time. This is a commitment of the supplies to guarantee the delivery of the item
at the exact moment of need. This limits the financial costs associated with stocking and
storing inventory items. This technique is more opportune in manufacturing, in which costs
of failure is limited to monetary loss.
Financial Control Inventory

 Because supplies are second largest cost incurred by the laboratory. Much attention
has been given to monitoring and controlling the supply expenses.
 A specialty management science is called Operations research has developed
several techniques and formulas for managing inventory:

1. Economic ordering quantity – answers the question of how much to order.

2. Economic ordering point (EOP) – also referred as reorder point (ROP), which provides
the base or safety level of reordering inventory.
3. Optimal reorder time (ROT), which helps to establish the best times to order to take
advantage of the EOQ ad EOP.

 In order to determine the EOQ, EOP and ROT, managers must understand certain
underlying concepts relating to inventory.

a. Annual usage – determining level of inventory needed is based on the workload of the
laboratory. Historical ordering data based on the actual purchases and usage as well as
predictions of future volume influences the anticipated level of supplies that must be
ordered.
b. Average Daily Usage – this information can be obtained by dividing the amount of
supplies ordered in a year by 365 days.
c. Cost of Ordering – the cost of running a centralized purchasing department is directly
tied to the number of purchase orders placed and the associated works involved with
keeping track of invoices as products are received and shipped.
d. Annual Holding Cost – it involves decisions based on bulk orders, space utilization and
whether it is better to have the product on hand or in supplier’s warehouse.
e. Cost per Unit – is a straightforward calculation once the decision has been made as to
the best price available. Factors such as quantity discounts and container size (e.g. box
case, truck load) affects this decision. Dividing the purchase price by the container size
provides this value.
f. Lead time – also known as advantage notice, needed between placing an order and its
arrival is an especially important consideration. It influences the minimum inventor that must
kept in stock, as well as the quantity that needs to be requested.
2.3. Forums

FORUMS:

Answer the following questions by clicking the links below.

FORUM 1
FORUM 2

FORUM 3

2.4. Assignment

 Download and answer the worksheet: Assignment in Material Management

 Answer the worksheet using Adobe Acrobat Reader PDF Fill and Sign Feature OR you
may download and print the worksheet, answer the questions in black ink then scan and
save to PDF OR you may copy and paste it to the Microsoft Word to answer the
questions the save it to PDF.

 Submit your work by uploading your assignment here in NEUVLE by following the
instructions indicated on this
link: https://college.neu.edu.ph/pluginfile.php/185133/mod_resource/content/1/HOW%20TO
%20SUBMIT%20ASSIGNMENT%20IN%20A%20COURSE.pdf

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Module7 - Total Quality Management in

Clinical Laboratory
Site: New Era University
Course: MTLM21-18 - Laboratory Management
Book: Module7 - Total Quality Management in Clinical Laboratory
Printed by: April Angela D. Pabello
Date: Monday, 20 December 2021, 12:27 PM
Description
 Lesson 1: Title

Table of contents
 1. Introduction/Overview
o 1.1. Learning Outcomes
o 1.2. Monitoring the Quality of Laboratory Measurements.
o 1.3. Quality Concepts
o 1.4. Major Figure in Quality Management
o 1.5. Westgard Rule
o 1.6. Basic Statistics in Quality Management
o 1.7. Quality Management Program

1. Introduction/Overview
Quality Assurance

The right result, at the Right time, on the Right specimen, from the Right patient, with
result interpretation based on Correct reference data, and at the Right price

Elements of Quality Assurance

1. Quality Assessment - involves Internal Quality Assessment and External Quality
Assessment.
2. Quality Control - evaluation and validation of the test; Internal quality control; and
Equipment evaluation and validation.

What is Quality Control in Clinical Laboratory?

A system designed to increase the probability that each result reported by the laboratory
is valid and can be used with confidence by the physician making a diagnostic or
therapeutic decision.

Purpose of Quality Control

The goal of QC is to detect errors and correct them before patient’s results are reported.

1.1. Learning Outcomes

At the end of this module the students will be able to:

1. Define Quality Assurance, Quality Control, Quality Management, Quality Assessment and
Improvement in Clinical Laboratory.
2. Discuss the Monitoring the Quality of Laboratory Measurements.
3. Enumerate and Discuss the Major Figures in Quality Management and their respective
contribution.
4. Define the terms and formula utilized in Basic Statistics.
5. Discuss and apply the utilization and examination of Basic Statistical Graphs in the
Quality Control.
6. Discuss the concepts of error and mistakes
7. Discuss the Quality Control Sample.
8. Apply Quality Management Principles.

1.2. Monitoring the Quality of Laboratory Measurements.

Clinical laboratories perform qualitative, semi-quantitative and quantitative tests on variety

of biologic specimens.

1. QUALITATIVE

o These are tests in which a particular characteristic of specimen is determined

to be either present or absent. These are called binary discrete variants.
o Ex. Blood typing or Microbiologic identification in specimen.
o Results are in the nature of Positive or Negative; Reactive or Nonreactive.
o Examination shows what particular characteristics are present or absent in
specimen.

2. SEMI-QUANTITATIVE

o These are the test in which the degree of positivity or negativity is roughly
estimated, usually by visual identification.
o Example is urine dipsticks, chemical test such as benedicts etc.

3. QUANTITATIVE

o These are the test in which some instrument measures the amount of
particular substances, property and the result is expresses numerically.
Example is Chemistry and Hematology Tests.

 Shewhart set the basic principles of industrial quality control in 1931.

 Measurements were made of items produced by a machine or sequence of
machines and the average value and range of values of the measurements were
determined.
 Tolerance limits is an acceptable product then were established, and product
uniformity could be assured by continual surveillance of there critical measurements
to detect deterioration of machine performance and by correction of problems as
they become evident.
 Most quantitative analytical procedures involved several operations or steps and
each operation is subject of some degree of inaccuracy or imprecision to the
possibility of mistake.
 The attainment of these intra- and inter- laboratory aims require that all laboratory
personnel-technologists, supervisors and directors be knowledgeable of the causes
of analytical inaccuracies and of the techniques that are available for their detection,
correction and control.
 Knowledge is required of the degree of the inaccuracy and imprecision allowed if
analytical values are to be clinically useful.
1.3. Quality Concepts

 Quality is like love, everyone knows what it is, but no one knows exactly how to
describe or measure it.
 To develop a plan to assess and ensure the quality of the services delivered by the
laboratory, the manager must have a full understanding of both the history and
philosophy of quality as well as knowledge of specific statistical technique and their
application to the laboratory.

1. Quality Control (QC)

 Study of errors and focuses on the test procedures.

 Refers to the standards and techniques the measure the quality of the product in the
isolation from the needs of the customer or patient.
 It relies heavily on quantitative statistical methods that focus on the final product as
defined by standards set by the producer.
 It refers to specific activities directed toward monitoring the individual elements of
care (ex. Instrument and test procedure).
 Example, if the laboratory tests fall within the acceptable QC ranges established for
the items (QC Model), the technologists are secured that they are turning out a high-
quality result.
 Quality control in Laboratory Medicine has been defined as the study of those errors,
which are the responsibility of the laboratory and the procedures used to recognize
and minimize them.
 Quality Control Programs have been an integral part of the inspection systems by
the Health Facilities and Services Regulatory Bureau (HFSRB), Department of
Health. The supervising pathologist should insure that the quality is organized for
periodic review or every major portion of the clinical laboratories and that the
program can be documented for the inspector.

2. Quality Assurance (QA)

 Overall activities conducted by the institution that are directed toward assuring the
quality of services provided.
 Quality assurance focused on the recipient – the patient. Furthermore, QA focuses
on the monitoring of outcomes or indicators of care.

3. Total Quality Management (TQM)

 Quality management program includes each component (customer, producer, and

supplier) in the creation process from the acquisition of supplies to active follow-up
after the product or service have been received by a delighted customer.
  JACHO and ISO – organizations that conducts continuous performance
improvement program.

4. Quality Assessment and Improvement (QAI)

 It focuses on the success of the organization in designing and achieving its set of
goals and objectives (continuous performance improvement). JACHO established
nine dimensions of performance improvement plan such as:
a. Efficacy f. Continuity
b. Appropriateness g. Safety
c. Availability h. Efficiency
d. Timeliness i. Care and respect
e. Effectiveness

1.4. Major Figure in Quality Management

1. PHILIP CROSBY

 Evangelist of Quality Management by preaching, “Quality is Free.” He propounded

that:
a. Quality is Free. Poor Quality is expensive.
b. Do things right the first time
c. Zero defects is the only legitimate goal of quality program.

2. W. EDWARDS DEMING

 Proposed the 14 TQM points to bring about a “delighted customer”

1. Create constancy of purpose toward service improvement.
2. Adopt the new philosophy
3. Cease dependence inspection to achieve quality.
4. End the practice of awarding business solely on the price tag
5. Constantly improve the process of planning, production and service
6. Institute training on the job
7. Institute leadership for people and systems improvement.
8. Drive out fear in order to encourage employees to work together.
9. Breakdown barriers between Departments and work areas.
10. Eliminate slogans, exhortations, and producing targets.
11. Eliminate numerical quotas for management and the workforce.
12. Remove barriers to pride of workmanship
13. Institute vigorous program of education and self-improvement for everyone in the
organization.
14. Put everyone in the organization to work accomplishing the transformation.

3. JOSEPH DURAN

 He established the concept that QUALITY is a continuous improvement process that

requires manager active pursuit in reaching and setting goals for improvement.
 He was the leader in promoting PARTICIPATORY management styles. He pointed
out that it was necessary for all employees to be included in and committed to the
continual process of designing and producing a quality product.
4. JAMES O. WESTGARD

 He propounded the MULTI-RULE SYSTEM in the evaluation of the quality control

data in the medical laboratory particularly the multi-ranged controls used in Clinical
Chemistry (Westgard Rules).

1.5. Westgard Rule

The individual rule are defined below. The "thumbnail" graphic next to a rule shows an
example of control results that violate that rule. You can click on a graphic to get a larger
picture that more clearly illustrates the application of each control rule.

13s refers to a control rule that is commonly used with a Levey-Jennings chart when the control limits
are set as the mean plus 3s and the mean minus 3s. A run is rejected when a single control
measurement exceeds the mean plus 3s or the mean minus 3s control limit.
12srefers to the control rule that is commonly used with a Levey-Jennings chart when the control limits
are set as the mean plus/minus 2s. In the original Westgard multirule QC procedure, this rule is used
as a warning rule to trigger careful inspection of the control data by the following rejection rules.

22s - reject when 2 consecutive control measurements exceed the same mean plus 2s or the
same mean minus 2s control limit.

R4s - reject when 1 control measurement in a group exceeds the mean plus 2s and another
exceeds the mean minus 2s. This rule should only be interpreted within-run, not between-run.
The graphic below should really imply that points 5 and 6 are within the same run.
41s - reject when 4 consecutive control measurements exceed the same mean plus 1s or the
same mean minus 1s control limit.

10x - reject when 10 consecutive control measurements fall on one side of the mean.
In addition, you will sometimes see some modifications of this last rule to make it fit more easily with
Ns of 4:

8x - reject when 8 consecutive control measurements fall on one side of the mean.

12x - reject when 12 consecutive control measurements fall on one side of the mean.
The preceding control rules are usually used with N's of 2or 4, which means they are
appropriate when two different control materials are measured 1 or 2 times per material.

What are other common multirules?

In situations where 3 different control materials are being analyzed, some other control rules
fit better and are easier to apply, such as:

2of32s - reject when 2 out of 3 control measurements exceed the same mean plus 2s or mean
minus 2s control limit;
31s - reject when 3 consecutive control measurements exceed the same mean plus 1s or mean
minus 1s control limit.

6x - reject when 6 consecutive control measurements fall on one side of the mean.
In addition, you will sometimes see some modification of this last rule to include a larger number of
control measurements that still fit with an N of 3:

9x - reject when 9 consecutive control measurements fall on one side of the mean.

A related control rule that is sometimes used, particularly in Europe, looks for a "trend" where several
control measurements in a row are increasing or decreasing [note: it is increasingly rare to see this
rule in use]:

7T - reject when seven control measurements trend in the same direction, i.e., get progressively
higher or progressively lower.
How do you perform multirule QC?

You collect your control measurements in the same way as you would for a regular Levey-
Jennings control chart. You establish the means and standard deviations of the control
materials in the same way. All that's changed are the control limits and the interpretation of
the data, so multirule QC is really not that hard to do! For manual application, draw lines on
the Levey-Jennings chart at the mean plus/minus 3s, plus/minus 2s, and plus/minus 1s.
See QC - The Levey Jennings chart for more information about preparing control charts.

In manual applications, a 12s rule should be used as a warning to trigger application of the
other rules, thus anytime a single measurement exceeds a 2s control limit, you respond by
inspecting the control data using the other rules. It's like a yield or warning sign at the
intersection of two roads. It doesn't mean stop, it means look carefully before proceeding.

How do you "look carefully"? Use the other control rules to inspect the control points. Stop if
a single point exceeds a 3s limit. Stop if two points in a row exceed the same 2s limit. Stop
if one point in the group exceeds a plus 2s limit and another exceeds a minus 2s limit.
Because N must be at least 2 to satisfy US CLIA QC requirements, all these rules can be
applied within a run. Often the 41s and 10x must be used across runs in order to get the
number of control measurements needed to apply the rules. A 41s violation occurs whenever
4 consecutive points exceed the same 1s limit. These 4 may be from one control material or
they may also be the last 2 points from a high level control material and the last 2 points
from a normal level control material, thus the rule may also be applied across materials. The
10x rule usually has to be applied across runs and often across materials.

Computer applications don't need to use the 12swarning rule. You should be able to select
the individual rejection rules on a test-by-test basis to optimize the performance of the QC
procedure on the basis of the precision and accuracy observed for each analytical method
and the quality required by the test.
1.6. Basic Statistics in Quality Management

STATISTICS IN QUALITY MANAGEMENT

1. Accuracy – the closeness of the result to the true or actual value of an analyte when
running the test; more commonly called “hitting the bulls-eye.”
2. Precision – how well a procedure reproduces a value.
3. Data Population – a term used in statistics to describe and define the items that are
being studies at particular time.
4. Population Sample - part of a population that is used to analyze the characteristics of
that population.
1.Slovin’s Formula
2.Lynch et.al. Formula
3.Cochran’s Formula / Modified Cochran’s Formula

5. GAUSSIAN DISTRIBUTION – describes the statistical phenomenon whereby members

of the population are usually evenly disbursed around the population mean.

 Also termed as BELL SHAPE CURVE, NORMAL DISTRIBUTION FREQUENCY

POLYGON and LEVY JENNINGS CHART.

 Uses the criteria of Westgard rules and the performance limits of Levey-Jennings
Charts.

 Example: 68.2% are within 1SD of the mean

 95.4% are within 2SD of the mean

 99.7% are within 3SD of the mean

6. MEAN (X) – the arithmetic average of all data contained in a sample population or an
algebraic test.
7. STANDARD DEVIATION – a measurement of precision or the tendency of the values in
each population to cluster center or scatter around the mean.
8. COEFFICIENT OF VARIANCE (CV) – the standard deviation expressed as a percentage
of the mean; considered a measurement of precision and variability.

GRAPHICAL PREENTATION IN STATISTICS

1. CIRCLE or PIE CHART – circular figure with areas marked off. Shaded or sketched
according to percentage or each component compared to whole.
2. BAR GRAPH – helpful in resenting comparative interpopulation and intrapopulation
factors.
3. LINE GRAPH – useful for plotting and tracking data over period of time. This is very
adaptable for displaying historical data.

GAUSSIAN DISTRIBUTION DISPLAYS

 There are two popular methods of displaying FREQUENCY DISTRIBUTION,

Characteristics of a population.
1. HISTOGRAM. This uses a bar graph format to show the relative size or frequency of
each class interval. A class interval is the statistical term for each part of the population.
For example, one bar may be represent the age group 20-30 in a patient population.
2. FREQUENCY POLYGON. Line graphs that give the FREQUENCY DISTRIBUTION its
descriptive name “BELL CURVE.”

METHODS

1. FLOW CHART. Identify and describe the exact sequence of work tasks and checking
out was for improvement by modeling alternative work routes.
2. CONTROL CHART. A chart used to lot control measurement against standards to
identify when a process is in or out of control.
3. PARETO CHART. The term assigned to a bar chart that is designed to illustrate the
classical pareto principle which states that 80% of all problems can be attributed to 20%
of the possible causes. According to this concept, the problems are matched with their
causes and plotted on a bar graph, the area in which managers should devote the
majority of heir attention and energy become readily apparent.
4. CAUSE and EFFECT diagrams. Graphical display with a “fishbone” appearance; used to
identify the possible cause of, or contributing factors to a problem or quality defect.
5. RUN CHART. Line graphs used to display data over a period of time.
6. SCATTER DIAGRAMS. Used to show the relationship between one variable and
another.
7. STORY BOARD. A story told in sequential picture displayed on a flip chart or other
visual aids.

LABORATORY DATA EVALUATION METHODS

1. LEVEY JENNING CHART – a control chart used to plot quality control values against
previously set limits to determine if a procedure is in or out of control.
2. YOUDEN PLOT – technique used to demonstrate and compare the performance of a
laboratory on paired samples with other laboratories.
3. MULTI RULE ANALYSIS – a set of rules such as WESTGARD rules that are used for
accepting or rejecting a control run.
Computation of Population Sample:
EXAMINATION OF CONTROL CHARTS

1. SKEWED CURVES – deviations from the symmetrical bell shaped appearance of frequency control.
2. TREND – a systematic drift in one direction away from the established mean.
3. DISPERSION – control or sample values that are widely scattered in an unusual and unexplained
pattern around the control chart.
4. SHIFT – a sudden switch of data points to another are of the control chart away from the previous
mean.
CONCEPT OF ERROR

1. RANDOM ERROR

o An error that may occur at any time and place within the production
process.
o Indicates inaccuracy.
o Need only to be closely monitored for possible occurrence.

2.SYSTEMATIC ERROR

o An error that occur in a constant direction or pattern

o Indicate imprecision
o Occur in a predictable direction.
 o Need immediate remedial action.

MISTAKES

o It is sometimes difficult to determine whether an erroneous result was due

to an analytical factor or to a mistake, but differentiation is of some
importance if the cause of the problem is to be identified and corrected.

SOME TYPES OF LABORATORY MISTAKES

1. Obtaining the specimen from the wrong patient.
2. Specimen mix up.

 Specimens labeled with wrong accession number

 Sera transferred to mislabeled tubes
 Improper cup number was recorded when a specimen was removed
from the auto-analyzer samples wheel to insert an emergency
specimen and all specimen on the wheel assigned false values.

3. Incorrect chart readings

 Incorrect reading of autoanalyzer peak.

 Incorrect read off from the standard curve.
 Read off form the standard curve assigned to wrong specimen

4.Dilution and calculation errors

 Analyst forgot to correct results for dilution.

 Samples diluted by first shift medtech were analyze by a second
shift medtech who was not informed of the prior dilution.
 A newly employed analyst thought a 1 to 2 dilution meant 1 volume
of serum and 2 volume of diluents rather than 1 volume each.

5.Reagent and Standard dilutions

 Distilled water rather than buffer was used to prepare reagent

 pH meter standardized with wrong buffer.
 Reagent contamination.
 New reagent used without checking against old reagent.

6.Instrument Problems

 Slow clock used for a times reaction.

 Recorder not properly warmed up; blank reading unstable
  Broken balance used to weigh out standards.

7.Miscellaneous

 Specimens left at room temperature by first shift medical

technologist to be analyzed by second shift medical technologist;
second medical technologist s not report for work and specimens
were not analyzed until the next day.
 Analyst calculated results mentally rather than drawing a standard
curve or calculating a factor, the results were grossly incorrect.
 Initial computer print out was incorrect, and subsequent corrected
print out was ignored.

1.7. Quality Management Program

SAMPLES USED IN QUALITY CONTROL

1. Serum pool
2. Aqueous solutions of analytes
3. Liquid serum
4. Urine

The following are requirements in order for a quality control program be effective:

1.The samples had to be essentially equivalent one to the other.

2.The analytes in he sample had to be stable in storage over a substantial period of time
3.The material had to available in sufficient quantity to be used by many laboratories or by
single laboratory for a long period of time.

PROCEDURE IN MANUFACTURING QUALITY CONTROL PLASMA

1. Blood plasma is collected.
2. The fresh plasma is frozen for transport to a manufacturing plant.
3. Often an batch of control serum is to be prepared, as much as 2.00 liters of plasma is
thawed, pooled, supplemented with various analytes to achieve the desired concentration in
the final product , mixed thoroughly, filter and dispensed into vials. Materials are lyophilized
and capped under nitrogen.

QUALITY CONTROL in the Laboratory can be divided into major types:

1.Internal QC (Intralaboratory QC)

2.External QC (Interlaboratory QC)

MANAGEMENT OF QUALITY
  Many entities offer advice and programs for the management of quality in an
organization.
 These include the promise all, pre-packaged programs designed by extensive
consultants and the theory based concepts of Management by Objectives, Quality
Assurance , Total Quality Management.
 No matter what approach the manager takes, three areas or ingredients must be
properly aligned if the institution is to achieve its quality performance goals:

1. Philosophy or attitude of its people.

2. The operation system of the enterprise; and,
3. The actual quality assessment and monitoring program in place.

The Philosophy of Quality

 The attitude of people towards their work, themselves, the organization and their
customers is reflected in how they treat each other, view their shared interests in
achieving common goals, and view their professionalism in the delivery of their
product or service.
 The philosophy of caring and commitment to the delivery of a high-quality service
starts at the very top and permeates every crevice of the institution.
 It is directly tied to the priorities placed on the quality by the organization’s leadership
and is demonstrated in how managers spend their time, what attracts and consumes
their attention, and to whom they issue rewards.
 If the proper philosophy is not present , efforts expanded in the remaining two
ingredients –operational and quality management system –are wasted.

Operational Systems

 Quality Management begins with how well managers incorporate quality practices
into their management functions.
 Operational systems represent the actual practices taking place in an organization –
not good in intentions, wishes or future plans.
 The laboratory must have operational systems in place that ensure that every step
flows smoothly and continually toward the final delivery of a high quality service. The
following model illustrates the steps in the testing cycle that are part of the
operational systems and quality of laboratory practices.

Quality Management Programs

 It differ from operational systems.

 The former address specific issues and goals and are plans for ensuring compliance
or bringing about change; the later represent the final results of all efforts and are the
actual practices taking place.
 The wide variety of high quality management programs available to managers
includes MBO, quality circles and the elements of QC/MBO à QA.
 Quality Management programs also include the specialized functions that are part of
the technical operations of the laboratory and so crucial to the delivery of a quality
service.
 On going activities that can be defined directly as part of quality management
programs include:
 Preventive maintenance
 Policy and Procedure manual writing and review
 Quality control functions
 Staff orientation, continuing education and development
 Participation in proficiency testing
 Problem solving and trouble shooting
 Laboratory inspection, accreditation and licensure process.

 Philosophy, operational systems and quality management programs combine to

create the integrity of the quality management plan. Each is crucial to the success of
the laboratory in achieving its goal of delivering high-quality services to its patients.