Bio-Link Draft of Common Core Skill Standards

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BIO
-
LINK

DRAFT OF COMMON CORE TECHNICAL COMPETENCIES FOR
THE BIOSCIENCE LABORATORY


WHAT ARE THESE STANDARDS?


The following document is a draft of “common core”
technical
skill
competencies

that are
specific
for biotechnology. Common core refers to skills and knowledge that apply broadly to
most biotechnology workplaces. Specialized skills, such as operating a flow cytometer or
performing
the polymerase chain reaction
, while crit
ically important in some settings, are not
considered to be core and are not included here.



This document was created by Bio
-
Link and
draws on the Washington State Skill Standards
1

and the Department of Labor Skills Standards
2
, both projects that brought

in large teams of
biotechnology practi
ti
oners.


These standards are intended to describe the skills and underlying knowledge required of
entry
level
biotechnology technicians in:




Basic Bioscience Research/Academic Laboratories




Testing Laboratories
Relating to Biotechnology (e.g., pharmaceutical development
laboratories, quality control laboratories)




Small Scale Biotechnology Production Facilities (e.g., facilities that produce gram
quantities of enzyme using laboratory
-
scale equipment)




Bioprocessi
ng Pilot Plants




Large Scale Bioprocessing Facilities (Note: larger scale bioprocessing may have
additional requirements that are considered to be “core” relating to engineering and
mechanics.)


PRESENTATION AND ORGANIZATION OF THESE STANDARDS


It is not r
easonable to expect entry level technicians to establish processes and procedures in a
workplace, although they may do so later in their careers or in some situations. Therefore, these
standards frequently use the phrase “according to established procedure
s” to indicate that the
technician is following processes and procedures that were put in place by the employer.



These standards are organized around 10 core topics:


1.

Biotechnology
Industry
Fundamentals

2.

Health, Safety, and Security



3.

Basic Calculations

4.

Ro
utine Facility Support

5.

Quality Control and Assurance; Basic Regulatory Affairs

6.

Metrology

7.

Biological Solutions

8.

Basic Separation Methods

9.

Assays, Data Collection, Data Evaluation

10.

Cell Techniques


1.
Bio
technology

Industry
Fundamentals
:
Understanding t
he bio
technology

industry and
its interactions with society.

Critical Work Functions:



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Technical Content Areas
:

1.1
Major Application Areas



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1.2
Major
Technologies



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1.3 Business,
Legal Issues
,

and Ethics



Venture Capital, Angel Capital, Business Plans



Intellectual Property



Documentation



Patents



Confidentiality



Biomedical

Ethics



Scientific Accountability


2
.
Health, Safety, and Security
: Equipment, practices, and procedures
that

promote a
healthy, safe, and secure work environment.

Critical Work Functions:



Practice

Work Habits that
Protect Personal Safety, Provide Safety for others in the
Laboratory, and Protect the Safety and Security of the External Environment




Apply

First Aid if Required



Follow Established Emergency Procedures, if Required



Select and Use

A
ppropriate
P
ersonal
P
rotective
E
quipment
at All Times



Participate in
S
afety

and S
ecurity
T
raining and
Emergency D
rills



Identify U
nsafe or
I
nsecure
Conditions and Take Corrective A
ction

According to
Established Procedures



Maintain a
S
anitary and
C
lutter
-
free
Work E
nvironment



Mo
nitor,
U
se,
S
tore, and
D
ispose of
H
azardous
M
aterials
According to Established
Procedures



Operate Autoclaves Properly



Follow
A
pplicable
Health and Safety R
egulations

and Institutional Procedures



Follow
A
pplicable
Security R
egulations

and Institutional Proc
edures (e.g., keep areas
locked according to company procedures, do not remove items from premises that
should not be removed)

Technical Content Areas:


2.1 Understanding
Laboratory and Industrial Safety



Electrical
Hazards



Physical Hazards (e.g., glass and compressed gasses)



Chemical Hazards



Biological Hazards (e.g. understanding the nature of microbes at a basic level,
understanding that bacterial, viral, and fungal pathogens exist, understanding the
classification of bio
logical hazards into Biological Safety Levels; understanding concepts
such as “containment,” sterilization, and disinfection)



Radiological Hazards (e.g., understanding different types of radioisotopes and their
uses; understanding the concept of half
-
life
, understanding how radioisotopes can hamr
cells)



Aseptic Techniques

to Avoid Contamination



Disinfection and Sterilization





Use of
Safety Equipment
, Including But Not Limited to Personal Protective Equipment



Safety Symbols and Signs



Emergency P
rocedures (e.
g., how to clean a small chemical spills, how to operate a fire
extinguisher)


2.2 Proper Methods of Working with
Hazardous Materials



Safe Handling and Disposal of Chemical, Biological, and Radioactive Materials



Safe Operation of Electrical Equipment



Finding and Interpreting
Material Safety Data Sheets (MSDS)



Using the Information in MSDSs and Other Documents to Guide Work (e.g., using a
chemical fume hood when for chemicals that are toxic by inhalation)



Following Established
Chemical Hygiene Plans



Fo
llowing
Universal Precautions for Biological Pathogens



Secure Use and Handling of Biological Materials



Proper Disposal of Biological Materials



Following Practices Required at Biosafety Levels 1 and 2 (working at higher levels
requires special training)



Track
ing

and Report
ing

Safety Concerns According to Established Procedures



3.

Basic Calculations:

Math skills required to solve basic on
-
the
-
job problems

Critical Work Functions:



Perform Calculations Relating to Measurements



Perform Calculations
Relating to Reagent And Media Formulation and Dilution



Perform Calculations Relating to Data Acquisition and Analysis



Perform Calculations Relating to Monitoring Products and Processes and Quality Control



Perform Calculations Relating to Growing Cells an
d Analyzing Their Growth



Perform Calculations Relating to Instrument Calibration, Maintenance, and Use



Perform Calculations Relating to Performing Assays and Procedures


Technical Content Areas:

3.1 Basic Math Techniques



Exponents and Scientific Notation



Logarithms (e.g., converting between pH and hydrogen ion concentration)



Percents



Manipulating Algebraic Equations (e.g., converting between revolutions per minute and
relative centrifugal force in centrifugation, converting between absorbance and
transmitt
ance in spectrophotometry)



Solving Ratios and Proportions

3.2 Measurements



Units of Measurement and Converting between Units



Significant Figures and Recording Data with the Correct Number of Significant Figures



Determining Accuracy and Precision in
Measurements



3.3 Concentration



Various Methods of Expressing Concentration



Reagent, Solution, and Media Formulations



Dilutions of Reagents, Media, and Solutions



Concentration and Dilution in Laboratory Procedures (e.g., calculating how to obtain a
given DN
A concentration for a restriction digest)

3.4 Data Acquisition and Analysis



Working with Linear Relationships (e.g., graphing linear relationships, understanding the
significance of an R value when provided)



Working with Nonlinear Relationships (e.g., ca
lculations involving radioactive decay and
half
-
life of isotopes)



Graphical Methods of Analysis and Data Display (e.g., preparing and interpreting
histograms and linear plots; using Excel for preparing graphs)



Statistical Methods for Describing Data (Descr
iptive statistics only, such as standard
deviation and mean)



Statistical Methods of Process Control (e.g., interpreting and using statistical control
charts)

3.5 Cell Growth



Growth Curves



Cell Counting, Density, and Cell Splitting


4.
Routine Facility
Support
:
Basic Functions Required to Support Operations

Critical Work Functions:



Periodically Inventory Supplies According to
Established
Procedures



Anticipate Required Materials and O
btain them

According to
Established
Procedures



Discard or Reprocess
Expired Materials

in Accordance with Established Procedures



Discard and Replace Broken Labware



Schedule Work Functions in an Organized Manner (e.g., conduct daily checks without
fail and document results appropriately, schedule use of shared equipment in
advance)



Clean/Sterilize Glassware, Equipment, Counters, Facility According to Established
Procedures



Monitor Facility Environment (
e.g.,

temperature) According to
Established
Procedures



Ensure that Equipment is Cleaned and Maintained According to Establi
shed Preventive
Maintenance Procedures



Document Facility Support Functions Using Logbooks, Computer Systems, Forms, and
Other Methods, According to Established Procedures


Technical Content Areas:



Using Catalogues and On
-
line Ordering



Entering Information into
Databases

and Retrieving Information




Basic Safety as Described in Part 2 above.



Basic Microbiology as Relates to Avoiding Contamination



Methods of Sterilization




5
.
Quality Control and Assurance
; Basic Regulatory Affairs
:
Practicing quality control
and assurance, and operating under governmental regulations.

Critical Work Functions:



Monitor, Inspect,
a
nd Verify Quality
of a
Product, Procedure,
Test Result, o
r Specimen
t
o Ensure Compliance
w
ith Standards
a
nd Specifications



Participate in

Validation
or Verification
Procedures
a
nd Protocols



Control
a
nd M
aintain Documentation Appropriate to Situation



Calibrate
a
nd
Verify or
Validate Equipment Systems
;

Assess Equipment Performance



Follow Established

Procedures



Take
a
nd Document

Corrective
a
nd Preventive Action
s

According
t
o Standard Operating
Procedures
o
r
a
s Directed

by Supervisor



Know
a
nd Comply
w
ith
Applicable
Current Federal, State, Local,
a
nd Industry
Regulations
, as Directed by Employer



Participate
i
n Compliance Training

Technical Content Areas:

5.1 Documentation



Good Documentation Practices (e.g., signatures, dating, use of indelible ink, witnessing
requirements
)



Electronic Practices versus Paper Practices (e.g., nature of electronic signatures,
computer security practi
ces)



Types of Documents (e.g., controlled vs. uncontrolled; laboratory vs. production)



The Roles and Uses of Various Types of Documents (e.g., batch records, SOPs,
labeling systems)

5.2
Quality Control/Quality Assurance



Continuous Improvement

Concepts



Th
e Technician’s Role in
Audits



Validation
/Verification

Testing



Product Specifications



Statistical
Methods of Data

Analysis

(see 3.4 above)



Following
Standard Operating Procedures



Proficiency Testing


5.3
Regulatory Compliance



History of Pharmaceutical
Regulations and the FDA



Organization of the FDA (e.g., the roles of CDER and CBER)



Understanding the Life Cycle of Medical Products

(e.g., Discovery through clinical trials,
NDAs, INDs)



Basic Understanding of
Good Laboratory Practices (GLP) and Good
Manufacturing
Practices (GMP)



Awareness of
Regulatory Agencies
at the Local, State and Federal Levels



Adherence to Procedures Established by the Employer that Comply with Regulatory
Requirements and Standards




6
.
Metrology:

Use measurement instrumentation properly with understanding of factors
that lead to correct results

Critical Work Functions:



Calibrate and Maintain Measuring Instruments (e.g., balances, pH meters,
thermometers, pipettes, spectrophotometers)



Make Weight

Measurements with Acceptable Accuracy and Precision (e.g., use proper
balance for each application, verify balance performance before use, monitor
temperature effects when weighing)



Make Volume Measurements with Acceptable Accuracy and Precision (e.g., us
e
micropipettes properly, ensure that devices are maintained according to established
procedures, avoid contamination of samples, select glassware properly)



Make pH Measurements with Acceptable Accuracy and Precision (e.g., calibrate
instrument properly, v
erify instrument performance before use, select proper electrodes
for a given application, compensate for temperature effects on pH)



Make Temperature Measurements with Acceptable Accuracy and Precision (e.g., select
proper device for application, verify pe
rformance of device before use)



Make Spectrophotometric Measurements with Acceptable Accuracy and Precision (e.g.,
ensure that instrument has been maintained according to established procedures)

Technical Content Areas:

6.1 General Principles of Metrology



National/International Standards, Calibration, and Traceability



Methods of Calibration and Performance Verification



Recording Values with Correct Significant Figures



Accuracy, Evaluating Accuracy (e.g., by calculating percent error)



Precision, Evaluating
Precision (e.g., by calculating standard deviation)



Types and Causes of Measurement Error



Uncertainty in Measurement (basics)



Preventive Maintenance Programs

6.2 Specific Measuring Methods



Weighing



Measuring Volume



Measuring Temperature



Measuring pH



Measu
ring Light Absorbance


7
.
Biological Solutions:

Be able to prepare, store, and handle reagents, solutions, and
media to support biological systems

Critical Work Functions:



Perform Calculations Necessary to Prepare Reagents to Particular Concentrations



Order, Verify, Store, Obtain, and Handle Raw Materials According to Established
Procedures





Discard Outdated Materials According to Established Procedures



Prepare or Obtain Water of Verified Suitability for Application



Wash/Prepare or Obtain Glassware, Pipe
ttes, and Other Devices of Suitable Quality for
Application According to Established Procedures



Verify Suitability of Required Measuring Instruments (e.g., calibrated balance)
According to Established Procedures



Weigh and Measure Raw Materials and Water
(or Other Solvent) with Suitable Accuracy
and Precision According to Established Procedures



Mix Reagents, Solutions, and Media Properly According to Established Procedures



Sterilize Reagents, Solutions, and Media Properly, When Necessary, According to
Esta
blished Procedures



Set Expiration Dates Appropriately, When Necessary, According to Established
Procedures



Verify that Reagents, Solutions, and Media were Made Correctly According to
Established Procedures



Label Reagents, Solutions, and Media Properly Acco
rding to Established Procedures



Store Reagents, Solutions, and Media Under Proper Conditions According to
Established Procedures



Follow Appropriate Documents According to Established Procedures



Document Work According to Established Procedures

Technical
Content Areas:



Calculations Relating to Concentration



Verification Methods for Measuring Instrument Performance



Measuring Instrument Operation; Avoiding Errors



Use of Mixing Devices



Methods of Sterilization and When Each is Used



Methods to Verify Successfu
l Sterilization



Operation of Sterilization Instruments (e.g., autoclaves, filtration devices)



Methods of Assessing the Quality of Solutions, Reagents, and Media (e.g., checks of
conductivity or osmolarity, sterility checks)



Storage Methods for Solutions
and Media



Basic Chemistry of Buffers and pH



8
.
Basic Separation Methods:

Be able to use centrifuges
,

filtration systems
, and
electrophoresis devices

that are appropriate for a given application in a safe and
effective manner
.

Critical Work Functions:

Follow established procedures to:



Operate Centrifuges



Use Filtration Devices and Systems



Use Electrophoresis Systems



Technical Content Areas:


9.1 Centrifugation



Selection, Purchase, Use of Centrifuge Rotors, Bottles, Tubes, and Adaptors that are
Appropriate for Specific Applications



Centrifuge/rotor Safety Concerns



Proper Operation of Centrifuge



Maintenance Requirements for Centrifuges and Rotors

9.2 Filtration



Selection, Purchase, Use of Filtration Devices Appropriate for Specific Applications



Maintenance and Operation of Filtration Systems

9.3 Electrophoresis



Prepar
ation or Obtaining of

Gels for Electrophoresis (e.g., prepar
e

agarose gels)



Set
-
Up and Conduct Electrophoretic Separations Efficiently and Safely



Proper Controls and Standards

(e.g., use of molecular weight markers, known
standards)



I
solate, Identify,
a
nd Prepare
Samples



Prepare Documentation Associated with Samples



Document Electrophoresis Procedures and Results



Evaluate
Results
o
f
Separations



Report Results in Written Tec
hnical Reports and Orally



Recognize, Report, and Trouble
-
shoot Problems with Separations with Assistance of
Supervisor and According to Established Procedures (e.g., follow CAPA policy, if
present)


9
.
Assays, Data Collection, Data Evaluation
: Perform
tests on samples to provide
information about those samples; properly document, store, and evaluate results.

Critical Work Functions:

Follow established procedures to:




Set
-
Up a
nd Conduct Tests/Assays

According to Established Procedures
: Chemical,
Biological, Cli
nical, Environmental, Robotic, o
r Mechanical



Proper

Control
s

and

Standards

(e.g., negative, no template, controls in PCR)



I
solate, Identify,
a
nd Prepare
Sample/
Specimens
f
or
Assays



Prepare Documentation Associated with Samples and “Chain of
Custody”



Document Assay Procedures and Results



Evaluate
Results
o
f
Assays (e.g., determine amount of analyte in quantitative assay)



Report Results in Written Technical Reports and Orally (e.g., proper report format is
used, all resources are properly ref
erenced, graphs and tables are clearly labeled and
explained, data is properly analyzed)





Recognize, Report, and Trouble
-
shoot Problems with Assays with Assistance of
Supervisor and According to Established Procedures (e.g., follow CAPA policy, if
present)




Technical Content Areas:

9.1
Lab Skills



Positive and Negative Controls for Assays



Use of Standards in Assays



Sample Preparation, Storage, and Handling Methods



Chain of Custody Requirements for Samples



Following Standard Assay Procedures (e.g., those

in laboratory manuals,
manufacturer’s instructions)



Preparation of Assay Reagents (see part 7, above)



Operation of Instruments Associated with Assays (e.g., spectrophotometers)



Verification that Instruments have Been Maintained According to their Mainten
ance Plan



Use of
Laboratory Notebooks
Properly (or Appropriate Forms) for

Documentation



Methods of Data Analysis and Summary (see # xx above)



Proper

Labeling Techniques

for Samples and Standards



Methods of Verifying that an Assay is Performing Properly



Use

of Reference Standards, Standard Curves


10
.
Cell Techniques:

Be able to visualize cells using basic microscopic techniques, grow
cells aseptically, count cells, harvest cells.

Critical Work Functions:

Follow established procedures to:




Order, Verify,
Store, Obtain, and Handle Raw Materials According to Procedures



Discard Outdated Materials According to Procedures



Clean and/or sterilize laboratory and supplies



Monitor Cell Growth and Health



Maintain Suitable Environmental Conditions for Cell Growth



Fee
d, Passage/Transfer Cells



Prepare cultures for storage (e.g., put on proper media or freeze)



Thaw or begin fresh cultures from stocks



Monitor Gauges And Recording Instruments To Ensure That Specified Conditions Are
Maintained



Participate
i
n
t
he Installati
on, Modification,
a
nd Upgrade
o
f Equipment





Maintain t
he
Equipment a
nd Control Systems

Used for Cells



Perform Documentation

Technical Content Areas:

10.1 Cell Biology



Understand Basic Prokaryotic and Eukaryotic Cell Structure and Function (e.g., know
structures and functions of organelles, know key differences between prokaryotic and
eukaryotic cells.)



Understand Uses of Cells in Biotechnology (e.g., uses of cells in c
ancer research, cells
as “factories to produce enzymes and drugs, cells used for regenerative medicine
therapies)

10.2 Biological Safety

See Part 2.2, above


10.3 Laboratory Methods



Microscopy Techniques



Cell Counting Techniques



Cell Maintenance, Feeding,
Transferring



Calculations Relating to Cell Growth, Density, and Splitting



Cell Morphology and Health



Aseptic Techniques



Obtaining,
W
eighing,
M
easuring, and
C
hecking
R
aw
M
aterials
, Preparing Growth Media
for Prokaryotic and Eukaryotic Cells



Setting up
E
quipment for
Growing Cells; Monitoring Equipment



Sterilization of Equipment and Reagents



Safety and Security of Biological Materials




PRIMARY REFERENCES


1.
2007 Biotechnology and Biomedical Skill Standards;
Copyright 2007, State of Washington
through
the State Board for Community and Technical Colleges.


2.
Bioscience Competency Model
; United States Department of Labor.
http://www.careeronestop.org/COMPETENCYMODEL/pyramid.aspx?BIOSCI=Y