Medical Technology Laws and Ethics

and Laboratory Management

By: Jan Ethan V. Lovendino, RMT, MPSH

LABORATORY
MANAGEMENT
A. BASIC MANAGEMENT CONCEPTS

1. Management/Leadership Styles
a. Authoritarian - manager makes all decisions
without input from others; least acceptance and
commitment from staff

b. democratic – manager makes decision after

polling staff; better quality and acceptance.

c. Consensus – manager tries to get at least partial

agreement from all staff; good acceptance and
commitment

d. Laissez-faire – manager leaves decision to staff;

abdicates responsibility
A. BASIC MANAGEMENT CONCEPTS

2. Management/Leadership Theories
a. Maslow’s Hierarchy of needs - psychology theory
proposed by Abraham Maslow in which all
individuals focus on the fundamental needs and
once fulfilled will progress to higher needs.
NEED DEFINITION WORKPLACE CONTERPART
Physiological Survival needs (food, water, air, rest) Income
Safety Physical and psychological security Insurance, safe work
environment, job security
Social Sense of belonging, acceptance Social relationship with
affection coworkers
Esteem Respect, independence, Job title, privileges, respect of
appreciation, recognition colleagues
Self-actualization Realization of full potential Challenging work, autonomy,
professional growth
A. BASIC MANAGEMENT CONCEPTS

2. Management/Leadership Theories
b. Frederick Herzberg’s Motivator-Hygiene
Theory - employees base their satisfaction or
dissatisfaction with work, on hygiene factors
(company policies, wages, job security) and
motivator factors (status, advancement
opportunity, recognition, personal achievement)
c. Douglas McGregor’s Theory X and Y
 Theory X is that humans have an inherent
dislike of work and will avoid it if they can –
therefore they need to be “controlled”
 Theory Y is that the expenditure of physical
and mental effort in work is as natural as in
play or rest – therefore, it the job is satisfying,
the employee will be self-motivated.
A. BASIC MANAGEMENT CONCEPTS

2. Management/Leadership Theories
d. Tannerbaum -Schmidt Theory - a manager uses
a broad range of leadership styles based on the
prevailing circumstances in the current
environment.
e. Blake-Mouton Theory – describes five types of
management situations:
1. Impoverished management – low concern for
people and production
2. Authority-compliance – low concern for people,
but high concern on production
3. Middle-of-the-road management – medium
concern for people and production
4. Country club management – high concern for
people, but low concern for production
5. Team management – high concern for people
and production
A. BASIC MANAGEMENT CONCEPTS

2. Management/Leadership Theories
f. Hershey-Blanchard Theory - based on
situational models; there is no single “best” style of
leadership, but is more dependent on the task,
knowledge, and group dynamics for each
situation.

g. Fiedler Theory – based on two factors of

situational contingency; leadership style and
situation control; a given situation may require a
task-oriented or a relationship-oriented leader
A. BASIC MANAGEMENT CONCEPTS

3. Skills of Managers
a. Organizational skills – ability to conceptualize
and apply management process, systematize
workflow, make decisions, and communicate with
coworkers.
b. People skills – understanding basic theories of
human needs and work motivation.
c. Financial skills – effective use of and accounting
for the monetary assets of the company
d. Technical skills – synthesis of the first three skills
and the management of physical resources into
the operational parameters.
A. BASIC MANAGEMENT CONCEPTS

4. Foundation of Management
Processes
a. Mission – organization’s purposes

b. Goals – organization’s broad, long-term ambitions

c. Objectives – directives that describe how a goal

will be achieved; should be SMART (Specific,
Measurable, Achievable, Realistic, Time
bounded)
A. BASIC MANAGEMENT CONCEPTS

5. Functions of a Manager
a. Planning – establishing goals and objectives,
formulating policies to carry out objectives;
involves SWOT analysis: Strengths, Weaknesses,
Opportunities, and Threats

TYPES OF PLANS
1. Short range or tactical plan – covers a 1-5year
period and focuses on tasks that can be
completed in this time frame
2. Operational plan – may be for 1 year or one
budget period and concerns operations
3. Strategic plan – maps out the course of an
organization for approximately 20 years; evaluated
and modified yearly
A. BASIC MANAGEMENT CONCEPTS

5. Functions of a Manager
b. Organizing – coordinating resources to achieve
plans, defining working relationships, including line
of authority and workflow.
c. Directing – communicating, motivating,
delegating, and coaching; creating a climate that
meets the needs of individuals and the
organization.
 Major techniques for directives
1. Autocratic – detailed instructions given of
exactly how and what is to be done
2. Consultative – input is sought from
employees to help solve a problem or tackle a
project
d. Controlling – defining standards of performance,
developing a reporting system, and taking
corrective action when necessary.
B. QUALITY MANAGEMENT

1. APPROACHES TO QUALITY
MANAGEMENT
a. Management by Objective (MBO) targets
organizational and employee performance by
aligning goals and objectives throughout the
organization, including timelines and feedback in
the process

b. Total Quality Management (TQM) focuses on

teams, processes, statistics and delivery of
services that meet or exceed customer
expectations. It strives to continually look for ways
to reduce errors (defect prevention by empowering
employees and getting them to understand their
integral role within the system (universal
responsibility)
B. QUALITY MANAGEMENT

1. APPROACHES TO QUALITY
MANAGEMENT
c. Continuous Quality Improvement (CQI) is an
element of TQM that strives to continually improve
practices and not just meet established quality
standards. It is a team effort approach to identify
potential problems and correct them.

d. Six Sigma – based on statistics and quantitative

measurements; applied in the clinical laboratory to
reduce the frequency of test errors or the number
of DPMO (Defect per million opportunities). The
process consists of 5 steps: DMAIC (Define,
Measure, Analyze, Improve, Control)
B. QUALITY MANAGEMENT

1. APPROACHES TO QUALITY
MANAGEMENT
e. Lean – is designed to reduce waste (nonvalued
activities) and improve customer satisfaction. It is
often used in clinical laboratories to improve a
process such as turnaround time.

f. ISO 15189 – quality management system

developed specifically for clinical laboratories;
mandatory in some countries.

g. PDCA strategy or cycle (Plan, Do, Check, Act) –

most widely used approach to quality improvement
in the healthcare)
B. QUALITY MANAGEMENT

1. APPROACHES TO QUALITY
MANAGEMENT
h. Benchmarking – process whereby the best
process in one organization is modified to fit
similar processes in another organization.

i. Use of Pareto chars, cause-and-effect

diagrams and flow charts
B. QUALITY MANAGEMENT

2. REGULATORY ELEMENTS
a. Accreditation: the approval of an institution, part
of an institution, or program, demonstrating that it
meets all formal standards as defined by the
accrediting body

b. Certification: official acknowledgement of the

passing of a qualifying examination

c. Licensure: the process by which a competent

public authority grants permission to an
organization of an individual to engage in a
specific professional practice, occupation, or
activity.
B. QUALITY MANAGEMENT

3. QUALITY SYSTEM ESSENTIALS

Based on ISO standards; each covers
pretesting, testing and post testing
operations.
a. Organization
b. Personnel
c. Documents and records
d. Facilities and safety
e. Equipment
f. Purchasing and inventory
g. Information management
h. Occurrence management
i. Assessments – internal and external
j. Process improvement
k. Customer service
l. Process control
B. QUALITY MANAGEMENT

4. EMPLOYEE PERFORMANCE
APPRAISAL
a. Error of central tendency. Everyone is rated
toward middle of scale
b. Contrast error. An individual is rated lower
than justified because of comparison with
another exceptional individual.
c. Error of leniency. Everyone is rated high
d. Halo effect. Good performance in one are
influences evaluation in another areas
e. Reverse halo effect. Poor performance in
one area influences evaluation in other areas
f. Recency phenomenon. Judgments are
made based on recent events or unusual
incidents.
C. LABORATORY STATISTICS

1. Measurements of Center
a. Mean – average or arithmetic mean

b. Median – middle point of a data set after the

values have been rank-ordered

c. Mode – most frequently occurring value in a

data set.
D. QUALITY ASSURANCE

1. Phases
a. Pre-analytical – include test requisition, patient
preparation, patient identification, specimen collection,
labeling, specimen transport, handling and processing

b. Analytical – include reagents, preventive maintenance of

equipment, calibration, analysis of samples, and quality
control
- Standard/Calibrator - substance of known purity and
concentration used to calibrate an assay method and
to determine the concentration of the unknown
analyte.
- Control – solution containing various analytes with
known target values, analyzed with patient samples to
monitor analytical performance
D. QUALITY ASSURANCE

1. Phases
c. Post-analytical – include verification of calculations and
reference ranges, flagging and notification of panic/critical
values, delta checks, reporting of results

- Critical values – results that indicate a potentially life-

threatening situation; typically includes glucose, Na, K,
total CO2, Ca, Mg, phosphorus, bilirubin, ABG; requires
“a read-pack policy”
- Delta check – an algorithm in which a current
laboratory result is compared with results obtained on a
previous specimen from the same patient
D. QUALITY ASSURANCE

2. Quality control
a. Accuracy – closeness of the result to the true or actual
value
b. Precision – ability to produce a series of results that
agree closely with each other; commonly expressed in
terms of coefficient of variation; also called reproducibility
c. Internal/Intralaboratory QC
- Involves the analysis of at least 2 levels of control
every 24h for at least 20days
- Important for the daily monitoring of accuracy and
precision of analytical methods
d. External/Inter-laboratory QC= Proficiency testing
- Involves testing samples of unknown concentration of
analytes sent periodically by regulatory agencies to
participating laboratories
- Poor performance is indicated by an SDI of >2.0
D. QUALITY ASSURANCE

3. Analytical Variation
a. Types of Error in Laboratory testing
1. Random Error
- Present in all measurements due to chance or an
unpredictable cause
- Mislabeling, pipetting error, improper mixing of
sample and reagent, temp fluctuation

2. Systematic Error
- Influences observations, consistently in one
direction
- Deterioration of reagents, unstable reagent
blanks, calibration error, changes in the standard
concentration, contaminated control solutions,
instrument malfunction.
D. QUALITY ASSURANCE

3. Analytical Variation
b. Patterns in QC charts that indicate errors
1. Shift – formed by control values that distribute
themselves on one side or either side of the
mean for 6 consecutive days; usually indicates
calibration error

2. Trend – formed by control values that continue

to increase or decrease over a period of 6
consecutive days passing through the mean;
usually indicates deterioration of reagents

3. Outliers – highly deviating control values

caused by random or systematic errors
D. QUALITY ASSURANCE

3. Analytical Variation
c. Interpretation of Quality Control Results

1. Shewhart Levey-Jennings Chart – most

commonly used histogram in QC; allows the
laboratory to apply multiple rules and detect
errors even without the aid of a computer
D. QUALITY ASSURANCE

2. Westgard Control Rules

Rule Description Type of Decision
error
12s One control value exceeds the x̄ + 2SD; warning;
considered a warning rule accept
the run
13s One control value exceeds the x̄ + 3SD Random

R4s Distance between two levels of control

within a run exceeds 4SD
22s Two consecutive control values exceed Reject
either the x̄ + 2SD in the same the run
direction
41s Four consecutive control values exceed systematic
either x̄ + 1SD
10x Ten consecutive control values are on
the same side of the mean
D. QUALITY ASSURANCE

3. Analytical Variation
c. Interpretation of Quality Control Results

3. CUSUM – algebraic sum of the difference

between each QC results and the mean

4. Tonks-Youden plot – graphical technique for

analyzing interlaboratory data (monthly
means); identifies within-laboratory and
between-laboratory variability
D. QUALITY ASSURANCE

3. Analytical Variation
d. Steps taken when a control is outside acceptable
range
1. Hold patient results until problem is resolved
2. Rerun control (1 time only)
3. If control is still out, run a new vial of control or
another lot number
4. If control is still out, look for and correct any
problems, then run control
5. If control is still out, recalibrate, then run
control
6. If control is still out, get assistance from
supervisor or service representative
7. Once resolved, document corrective action
8. Evaluate all patient results in rejected run and
since last run with acceptable QC. Repeat
tests and issue corrected reports, as needed.
e. Retention of QC records
E. INFORMATION SYSTEM

Laboratory System of hardware, software, connections, and

information system communication protocols to handle all informational needs
of lab, from intake of requests to delivery of results
Hospital information Information system to handle all informational needs of
system hospitals, both clinical and administrative
Interface Hardware and software that allow for electronic
communication between 2 computer systems, even if they
use different programming languages
Unidirectional Interface that transmits electronic information in 2
interface directions, e.g., a point-of-care analyzer downloads test
results to LIS.
Bidirectional Interface that transmits electronic information in 2
interface directions, e.g., the LIS downloads orders from the HIS &
uploads results to the HIS
F. LABORATORY OPERATING COSTS

 Budget – a template for forecasting revenue and expenses

for an organization; preparation involves four processes;
development of goals, forecasting of revenue using budget
assumptions, forecasting of expenses, and ongoing
monitoring of both revenue and expenses

DEFINITION EXAMPLES
Capital expense Money used for physical assets Acquiring or upgrading facilities or
and is often depreciated over a equipment
5-plus year period
Operational Money used for day-to-day Employee wages, taxes, and the
expense operations general costs of doing business
Fixed costs Expenses that don’t fluctuate Instrument leases, maintenance
when volume of work changes contracts, computer services,
over short term equipment costs, facilities upkeep,
management salaries, custodial
salaries, employee benefits, lease
payments, rent, taxes
F. LABORATORY OPERATING COSTS

DEFINITION EXAMPLES
Variable costs Expenses that fluctuate directly Labor costs, supplies, reagents,
with change in work load disposables
Direct costs Costs associated with Supplies, reagents, controls,
performance of a test standards, disposables, equipment
costs, equipment maintenance
contracts, technical and supervisory
labor
Indirect costs Overhead Administration, plant maintenance,
security, utilities, building
depreciation, rent, taxes, insurance,
housekeeping, purchasing, billing,
regulatory expenses, LIS expenses
Unit cost/ cost Total of direct and indirect
per test expenses of producing a test
results
G. LABORATORY SAFETY

1. Biohazards
a. Four levels of biosafety
1. Biosafety level 1 – agents that have no known
potential of infecting healthy people

2. Biosafety level 2 – microorganisms associated with

human diseases that are rarely serious and for which
preventive or therapeutic interventions are often
availble

3. Biosafety level 3 – materials that may contain

viruses not normally encountered in a clinical
laboratory and mycobacteria

4. Biosafety level 4 – dangerous and exotic agents that

pose a high risk of aerosol-transmitted laboratory
infections and life-threatening disease for which
effective treatments are limited.
G. LABORATORY SAFETY

1. Biohazards
b. Biohazard label of chain of infection

Hand washing
Biohazardous waste disposal
Decontamination
Specimen bagging

SOURCE

N
SIO
HO

MIS
ST

NS
TRA

Standard precautions Hand washing

Immunization Personal protective
Healthy lifestyle equipment
Exposure control plan Aerosol prevention
Postexposure prophylaxis Sterile/ disposable equipment
Pest control
G. LABORATORY SAFETY

1. Biohazards
c. Hand washing – most important means of preventing the
spread of infection
- If hands are visibly soiled, wash hands with soap and
water for 1-2mins
- If hands are not visibly soiled, wash hands for at least
30secs or use alcohol-based hand cleansers.

d. Personal protective equipment – gloves, gown, face

shield or goggles, and mask or respirator
- Don in correct sequence (gown, mask, goggles,
gloves)
- Remove in correct sequence (gloves, goggles, gown
and mask)
G. LABORATORY SAFETY

1. Biohazards
e. Decontaminating of Body Fluid Spills
- 5.25% NaOCl or 10% chlorine bleach
- 1:10 dilution → 1 part household bleach + 9 parts
water
- Inactivates HBV for _______ and HIV for __________
f. Biological Safety Cabinet
Class Description Use
I Open front. Air passes through hepa Minimal personnel protection.
filter before being exhausted Doesn’t protect work surface
II Also called laminal flow; air passes Most commonly used in micro
through 2 hepa filters labs. Provides protection for both
worker and work
III Completely enclosed with glove For extremely hazardous
ports. Equipped with negative organisms.
pressure
G. LABORATORY SAFETY

2. Chemical Hazard
- MSDS (Material Safety Data Sheets)
- TLV (Threshold Limit Value) – allowable exposure value
during an 8hour shift
- The United Nations (UN) established nine classes of
hazardous materials
a. Class 1 – explosives
b. Class 2 – compressed gas
c. Class 3 – flammable liquids
d. Class 4 – flammable solids
e. Class 5 – oxidizer materials
f. Class 6 – toxic materials
g. Class 7 radioactive materials
h. Class 8 – corrosive materials
i. Class 9 – miscellaneous materials not otherwise
classified
G. LABORATORY SAFETY

2. Chemical Hazard
- Standard hazards identification system by the NFPA
Color codes and hazard types:
BLUE = toxic/ health
RED = flammability/ fire hazard
YELLOW = instability/ reactivity?
WHITE = specific

Degree of hazard:
0 = no hazard
1 = slight
2 = moderate
3 = serious
4 = extreme
G. LABORATORY SAFETY

3. Radiation Hazard
- Nonionizing forms of radiation emitted by equipment

Type Wavelength Example

Ultraviolet <400 nm Germicidal lamps used in
biologic safety cabinets
Visible spectrum 400-700 nm General illumination
Infrared >700 nm Heat lamps, lasers
Microwaves 3um – 3mm Microwave energy beam used
to accelerate tissue staining
Low frequency >1cm Radiofrequency coil in ICP-MS
G. LABORATORY SAFETY

4. Color Coding Scheme for Health

Care Wastes
Type of waste Color of container/bag
Non-infectious dry waste Black
Non-infectious wet waste Green
Infectious and pathological wastes Yellow with black band
Chemical wastes Yellow
Radioactive wastes Orange
Sharps pressurized containers red
G. LABORATORY SAFETY
5. Fire Hazard
Class Combustible materials
A Ordinary combustibles
B Flammable liquids and
gases
C Electrical equipment
D Combustible metals
Extinguishers
Ordinary combustibles,
water, dry powder, halon
Carbon dioxide, dry powder,
halon
Carbon dioxide, dry powder,
halon
Special agents
G. LABORATORY SAFETY

5. Fire Hazard
- Actions to take in the event of fire:
Rescue Alarm Contain Extinguish

- Correct use of fire extinguishers:

Pull Aim Squeeze Sweep