LABORATORY MANAGEMENT

PROFESSIONALISM

Professional ethics is the study of standards of conduct and moral judgments which
provide a basis for right and wrong conduct.

TORT LAW
• A tort is an act which gives rise to an injury or harm to another, and amounts to a
civil wrong for which courts impose liability.

Classi cation of Tort

Intentional Tort Unintentional Tort

INTENTIONAL TORT

Battery

Assault

Defamation

Fraud
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UNINTENTIONAL TORT

• Negligence – person responsible for committing a wrong, is careless and

responsible for the harm caused to another.

Malfeasance Misfeasance Nonfeasance

LEADERSHIP, MANAGEMENT AND ITS FUNCTIONS

o Art of getting things done through people; working with and thru people

1. Planning

• Thinking and analyzing portion of management process.

2. Organizing

• Process of structuring activities, materials an personnel for accomplishing

predetermined goals

3. Leading

• Process of supervising or leading worker to accomplish the goals of the

organization.

4. Controlling

• Involves the evaluation of activities. The process of determining if the company’s

goals and objectives are being met.

SKILLS OF A MANAGER:
1. Organizational skills

2. People skills

3. Technical skills

 Basic Management Responsibilities

Operations Management Quality assurance

Policies and procedures

Benchmarking

Productivity Assessment

Legislation/regulations/HIPAA Compliance

Medicolegal concerns

Continuing education

Staff meetings
Human Resources Job descriptions

Management Recruitment and staffing

Orientation

Competency assessment

Personnel records

Performance evaluation/appraisals

Discipline and dismissal

Financial Management Departmental budgets

Billing

Compliance regulations

Test cost analysis

Fee schedule maintenance

Marketing Management Customer service

Outreach marketing

Advertising

Website development

Client education

MANAGEMENT AND ORGANIZATIONAL THEORY

ORGANIZATIONAL DESIGN

1. Functional – Specialized units report in an upward chain of command. Clear

understanding of responsibility and authority. Functions best when the departments
are engaged in repetitive, e cient, routine task.

2. Self-contained – According to discipline, a location or customer group.

3. Matrix – takes advantage of skills and functions. Allows areas to concentrate on

specialized functions

4. Network – re ect information technology models. Consists of units, to reduce

duplications, and expand revenue generating services.

LEADERSHIP THEORIES

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 1. McGregor X and Y theory

• X theory relates to _______________________

• Y theory relates to _______________________

2. Fielder theory

• This theory indicates that the style used by the leader may vary according to the
situation with a very favorable or very unfavorable situation requiring a
_________________________ and a moderately favorable or moderately
unfavorable situation requiring a _________________________________________

3. Tannenbaum and Schmidt theory

• Styles can be plotted on a continuum from authoritative to democratic

4. Blake and Mouton theory

• Describes ve types of management situations

a. Impoverished management

b. Authority-compliance

c. Middle-of-the-road management

d. Team management

5. Harsey-Blanchard theory

• Four leadership situations:

a. Employee new to job

b. Employee has mastered some of the job, but needs supervision

c. Employee has mastered the job, but needs veri cation

d. Employee has mastered the job and is con dent

LEADERSHIP
• A pattern of behaviors used to engage others to complete tasks in a timely and
productive manner.

1. Supporting

• Provides physical and personal resources so that an individual can accomplish

his or her duties

2. Directing

• Presents rules, orders, or other de ned instructions to the individual

3. Delegating

• Provides low support and direction

4. Coaching

• Provides high support and direction

QUALITY ASSURANCE

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 o Quality assurance is a comprehensive set of policies, procedures, and practices
that are followed to ensure that a laboratory’s results are reliable. QA evaluates the
quality of services provided. It provides a way to prevent problems as well as deal
with problems that occur.

QUALITY ASSURANCE PLAN

1. All procedures and policies are in writing and available.

2. Sta performance is routinely evaluated.

• The employee evaluation process is a method of recognizing job excellence

and determining areas for development and training. The job evaluation is
directly linked to the job description and should be formative and summative
in nature and conducted often enough to provide feedback and direction for
the employee.

✓ The purpose of corrective action is to provide the employee with speci c

goals to enhance their e ectiveness and performance within the institution

a. The rst step is _________________________ to make the employee aware

of the situation and to open the lines of communication

b. The second step is ___________________________ that speci cally involves

stating the problem, performance in question, and o ering resources and
assistance (process is documented)

c. The third step is a _____________________________ that states the

problem, expected improvement in performance, and timeline for re-
evaluation of performance. This document is signed by the immediate
supervisor and employee. Failure to meet the stated requirements typically
results in dismissal of the employee.

3. Continuing education is used and documented.

4. A safety program is in place for sta and patients.

a. Occupational Safety and Health Administration (OSHA) standards are met. -

to develop and actively follow plans that protect laboratory workers from
potential exposure to hazardous chemicals. And to minimize the incidence of
chemically related occupational illnesses and injuries in the workplace.

b. Hazardous materials are identi ed and labeled.

c. Material Safety Data Sheets (MSDS) are available for each hazardous
material.

d. Employee safety training is documented

e. Records of any accidents (needle stick) are kept and reported to appropriate
authorities

f. Hazardous waste is properly disposed.

g. Universal precautions are strictly followed.

h. Safety equipment (e.g. re extinguishers, re blankets, safety showers,

goggles) is available to sta , and training in the use of this equipment is
performed and documented.

i. Electrical checks of all equipment are routinely performed.

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5. Specimen collection and handling (preanalytical) as wells as patient preparation
follows written guidelines and is documented

6. A QC program is in place (analytical). This ensures that the instruments, reagents,

and personnel are functioning properly.

a. A written QC program speci es:

1. Frequency of performing controls

2. Number of controls to be used

3. Types of controls

4. Acceptable limits for control results

5. Corrective action required if controls are out of range

b. QC plots of control results are used to detect shifts and trends

c. Equipment maintenance is performed and documented

d. Temperatures of incubators, certain instruments, and the room are noted and
documented.

7. Checklists are used to ensure that scheduled activities and duties are performed.

8. The laboratory must participate in and document results of Pro ciency Test. This
allows comparison of results from a number of laboratories.

9. The laboratory must be accredited by an appropriate agency. This gives o cial

approval and states that the laboratory follows all of the guidelines set forth by the
accrediting agency. Inspectors representing the accrediting agency view records,
documents, and visit the laboratory.

QUALITY MANAGEMENT
o Method for ensuring that all the activities necessary to design, develop and
implement a service are e ective and e cient with respect to the system.

o Total quality management

o Six Sigma is a structured process based upon statistics and quantitative

measurements through which process defects or errors are analyzed, potential
causes are identi ed, and improvements are implemented. A defect is anything that
does not meet customer requirements. It is an improvement program which goal is
to:

Six Sigma Step Example

DEFINE project goal or other deliverable that
is critical to quality

MEASURE baseline performance and related

variables

ANALYZE data using statistics and graphs to

identify and quantify root cause
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 Six Sigma Step Example
IMPROVE performance by developing and
implementing a solution

CONTROL factors related to the

improvement, verify impact, validate
benefits, and monitor over time

Laboratory Practice in Quality Control

1. Preventive Procedures – pre-analytic activities that are intended to establish a

system which leans towards providing accuracy

2. Assessment Practices – analytic activities that are done during the test to determine
whether the established systems are performing correctly

3. Corrective Practices – post-analytic activities to determine error and possible

sources of error to be able to correct the established system

LABORATORY SAFETY

• Biological hazards expose an unprotected individual to bacteria, viruses, parasites,,

or other biological entities that can result to injury. Exposure occurs from ingestion,
inoculation, tactile contamination, or inhalation of infectious material from patients or
their body uids/tissues, supplies or materials they have been in contact with or
contaminated needles, or by aerosol dispersion.

Protective Clothing

• Occlusive dressing

• Wear long-sleeved gowns with closed fronts or long-sleeved lab coats that are
buttoned closed while in the laboratory

• Wear lab coats inside the lab only

Hand Protection

• Gloves of proper size and materials must be provided

• Use antiseptic techniques

• Change gloves every after contact with each patient

Facial Protection

• Full-faced shields are preferred; if not available, use uid-resistant mask and eye
protection

Hazardous Wastes
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Top 0 - Will not burn

1 – Above 200F

2 – Below 200F

3 – Below 100F

4 – Below 73F
Bottom Oxidizer

Radiation

Use no water
Left 0 – Normal

1 – Slightly hazardous

2 – Hazardous

3 – Extreme danger

4 – Deadly
Right 0 – Stable

1 – Unstable if heated

2 – Violent chemical change

3 – Shock and heat may detonate

4 – May detonate

Fire Hazards

Types of Fires and Fire Extinguishers

Fire Type Extinguishing Material Type of Fire Extinguisher
Class A Class A Water
Class B Class B Dry chemicals, carbon
dioxide, foam or halon
Class C Class C Dry chemicals, carbon
dioxide or halon
Class D None
Sand or dry powder

Class ABC Dry chemicals

Class K Class K Liquid designed to prevent
splashing and cool the re

SUGGESTED GUIDELINES FOR RECORD AND SPECIMEN RETENTION

RECORDS
Requisition
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Quality Control
Instrument Maintenance
Blood bank donor/recipient records
Blood bank employee signature/initials
Blood bank quality control

REPORTS
Clinical Pathology Laboratory Reports
Autopsy Forensic Reports
Surgical Pathology (and bone marrow)
Reports
Cytogenetics Reports

TURN-OVER OF RESULTS
Surgical Pathology and Cytology
Autopsy Reports
Frozen Sections

SPECIMEN RETENTION
Serum and other body uids
Routine blood smears
Pathology/bone marrow slides
Pathology blocks
Microbiology smears
Blood bank donor/recipient specimens
Cytogenetics slides
Cytogenetics diagnostic images

LABORATORY WORKFLOW AND PERFORMANCE

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 • Preanalysis - refers to all activities that take place before testing

• Analysis - consists of laboratory activities that actually produce a result

• Postanalysis - comprises patient reporting and result interpretation

LABORATORY EQUIPMENT AND REAGENT PREPARATION

Centrifuge
• Used to separate substances of di erent mass or density


A. Horizontal head

• Swinging bucket type; the centrifuge tubes are held in a vertical position
when not moving, but are horizontal when the centrifuge is fully in motion

B. Angle Head

• Has a xed 25 -52 angle at which the tubes are held during centrifugation

C. Ultracentrifuge

• Generates the highest speeds

• In order to reduce the heat produced by the friction generated by high

centrifugal speeds, ultracentrifuges are refrigerated

Centrifuge Maintenance Procedure:

• Weekly – clean interior components with soap and water followed by freshly
made 10% v/v bleach solution, including sample buckets


• Monthly – check for unusual vibrations, braking mechanisms to ensure a

smooth, gradual stop, the timer of the centrifuge using a stopwatch


• Quarterly – check the revolutions per minute at several commonly used speeds
while centrifuging a balanced load using a tachometer or strobe light


Pipet


According to Design:

1. To contain – holds the particular volume but does not dispense the exact volume

2. To deliver – will dispense the exact volume indicated


According to Drainage Characteristics:

1. Blow-out – has a continuous etched ring located near the top of the pipet


2. Self-draining – no etched rings

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 According to Purpose:

1. Transfer pipet

• Volumetric – designed to transfer nonviscous or aqueous solutions

• Ostwald-Folin – viscous uid

• Pasteur pipet


2. Graduated/Measuring pipet

• Mohr pipet – without graduations to the tip

• Serological pipet – with graduations to the tip

• Bacteriological pipet


Chemicals Used for Reagent Preparation


1. Analytical Reagent Grade

• For quantitative and qualitative analyses


2. Ultrapure Reagent

• Type of reagent that has been put through additional puri cation steps


3. Chemically Pure or Pure Grade

• Limitations of this type are not usually stated and is not recommended for
research and analytical chemistry


4. Technical or Commercial Grade

• Used primarily in manufacturing and should never be used in clinical

laboratory setting


5. United States Pharmacopoeia (USP) and National Formulary (NF)

• Approved for human consumption but not applicable for laboratory

analysis


Grades of Reagent Water


1. Type I Reagent Water

• Used for procedures that require maximum water purity for accuracy and
precision


2. Type II Reagent Water

• Acceptable for preparation of reagents and quality control materials


3. Type III Reagent Water

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 • Used for washing glasswares


Automation

Principles:

1. Single channel – able to perform only one test with a dedicated portion of the
instrument

2. Multi-channel – able to perform a variety of tests at the same time with separate
dedicated instrument components

3. Random access – test can be performed in a variety of sequence

4. Batch analysis – group of samples are analyzed at the same time for the same
test

5. Sequential analysis – performing a set of tests in a particular order one after

another on  given specimen

6. Open reagent system – reagents can be purchased from a variety of sources

7. Closed reagent system – reagents are purchased only from the manufacturer of
the instrument because of unique container or format


1. Continuous Flow Analyzer

• Sample is aspirated through the sample probe into a continuous reagent
stream

• Liquids are pumped through a system of continuous tubing

• Samples are introduced in a sequential manner following each other on

the same network. Air bubbles serve as separating and cleaning media

• Shows signi cant carryover problems


2. Centrifugal Analyzer
• Uses the force generated by centrifugation to transfer and then contain
liquids in separate cuvets for measurement at the perimeter of a spinning
rotor

• Most capable of running multiple samples, one test at a time, in a batch


3. Discrete Analyzer
• Capability of running multiple tests one sample at a time or multiple
samples one test at a time.

• Most popular and versatile analyzer


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