POL_INSIGHT_2013_A

A Continuing
Education
Publication for the
Physician Office
Laboratory
In this Issue:In this Issue:In this Issue:In this Issue:In this Issue:
QualityQualityQualityQualityQuality
AssuranceAssuranceAssuranceAssuranceAssurance
Simplified:Simplified:Simplified:Simplified:Simplified:
PPPPPararararart It It It It I
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Calculating
the Cost of
CME
ISSUE 67
POL Insight2013-A

Published by the American Academy of Family
Physicians
11400 Tomahawk Creek Parkway
Leawood, KS 66211-2672.
Editor and Writer:
Cheryl Murray, MPA, MT(ASCP)SM
Authors:
Jason A. Kendall
Karen Appold
Peggy Luebbert
It is the policy of the AAFP that all individuals in a position to control
content disclose any relationships with commercial interests upon
nomination/invitation of participation. Disclosure documents are
reviewed for potential conflicts of interest and, if identified, they are
resolved prior to confirmation of participation. Only these participants
who have no conflict of interest or who agree to an identified
resolution process prior to their participation were involved in this CME
activity.
All individuals in a position to control content for this activity have
indicated they have no relevant financial relationships to disclose.
Barbara Mitchell
Program Manager
e-mail bmitchel@aafp.org
Lisa Henderson
Manager, Operations
e-mail lhenders@aafp.org
Cheryl Murray
Manager, Education & Technical Assistance
e-mail cmurray@aafp.org
Shaurna Andrews
Program Coordinator
e-mail sandrews@aafp.org
Karen Bergman
Program Coordinator
e-mail kbergman@aafp.org
AAFP-PT FAX
913-906-6079
Visit our Web site for information about the PT
program, our POL Topics information and
continuing education material
http://www.aafp.org/pt
AAFP-PT StaffAccreditation Statements
AAFP Physician’s Proficiency Testing Program has
been reviewed and is acceptable for up to 12
Prescribed credits by the American Academy of
Family Physicians. AAFP accreditation begins 3/1/
13. Term of approval covers three events offered
within one year from this date with option for
yearly renewal.
The American Academy of Family Physicians is
accredited by the Accreditation Council for
Continuing Medical Education (ACCME) to provide
continuing medical education for physicians.
The American Academy of Family Physicians
designates this educational activity for a maximum
of 12 AMA PRA Category 1 Credit(s)™. Physicians
should only claim credit commensurate with the
extent of their participation in the activity.
Credit may be claimed for one year from the date
of this event.
AAFP-PT is approved as a Provider of continuing
education programs in the clinical laboratory
sciences by the ASCLS P.A.C.E.®
Program. AAFP-PT
is also an approved provider for California clinical
laboratory licensees under the P.A.C.E.®
Program.
The level of instruction for this event is basic. This
event is worth 4 P.A.C.E.®
Contact Hours.
The PT Department is staffed from 8:30 AM to
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during these hours . . . or use our voice mail
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or send one of us an e-mail !

Event 2013-A P.O.L. Insight Page 3
CME Due Dates and P.A.C.E.®
Course Codes
Event 2013-A .................... February 28, 2014....................... 254-001-13
Event 2012-B ........................May 31, 2013 .......................... 254-002-12
Event 2012-C ...................September 30, 2013 ..................... 254-003-12
CME Learning Objectives
Following completion of the self-instructional
material, the participant will be able to:
1. Demonstrate improved understanding of
the CLIA requirement on developing a
Quality Assurance Program; assess their
current program & determine usefullness
using probing examples.
2. Identify ways that changes to Hazard Com-
munications affect criteria for hazard classi-
fication; describe new labelling require-
ments; describe changes to MSDS format;
and describe employee & contractor train-
ing requirements.
3. Identify budget-friendly alternative means
of obtaining CME.
To earn the CME, login to your laboratory PT
Central hompage. Click the CME link on the left
side of the screen. Follow the directions the
access the assessment.
Table Of Contents
Quality Assurance Simplified, Part I.. 4
Calculating the Costs of Continuing
Education ..................................... 8
The New HazCom: Globally
Harmonized Sytesm ..................... 11
Obtaining CME Proof of
Participation................................ 14
CME Questions ............................ 15
Guide to PT Central...................... 19
Lab Tests Online (www.labtestsonline.org), a comprehen-
sive internet resource for healthcare professionals &
consumers is seeking physician volunteers to serve on the
Editorial Board.
Responsibilities include review of website content from a
practicing physician perspective. Time committment is 1-2
hours per month.
To volunteer, please contact George Linzer at GLinzer
@aacc.org or Katie Schaeffer at KScheaffer@aacc.org.
Need Documentation of CME Credits?
See Page 14 of this issue for details on
obtaining credit & documentation for this
CME activity.
1. A
2. D
3. B
4. D
5. A
6. B
7. B
8. C
9. B
10. B
2013-A CME Answers
11. D
12. B
13. C
14. B
15. C
16. D
17. C
18. A
19. A
20. B
21. B
22. A
23. B
24. A
25. A
26. B
27. A
28. C
29. A
30. D

Event 2013-AP.O.L. InsightPage 4
Quality Assurance
Simplified: Part I
By Jason A. Kendall, MBA, CLS. President & CEO,
Physician Office Laboratory Solutions.
www.polsolutions.com
A commonly misunderstood feature of the Clinical
Laboratory Improvement Act of 1988 (CLIA ’88) is
the ongoing process of Quality Assurance (QA).
According to the federal guidelines laboratories that
perform moderate or highly complex testing must
have written procedures that are designed to
monitor and evaluate the total testing process. The
law goes on to further state the laboratory’s quality
assurance program must:
• evaluate the effectiveness of its policies and
procedures
• identify and correct problems
• assure the accurate, reliable and prompt
reporting of test results
• assure the adequacy and competency of the
staff
Based on the evaluations the laboratory must
revise and/or update its policies and procedures to
reflect the total overall quality improvement that is
desired in patient care. The relevance of this article
is to help the reader have a better understanding of
the QA requirement and to offer suggestions that
can help the reader identify potential issues and/or
needs of improvement.
Simplifying QA is basically a matter of viewing it as
an umbrella that covers all facets of the laboratory.
This includes technical, non-technical, and all the
sites and/or locations where any part(s) of the
testing process are done. QA helps the laboratory
take a good look at itself through an internal
process to help identify issues that are affecting
quality patient care. QA is not a onetime process
but rather an ongoing mechanism that monitors
the total testing process. The total testing process
is pre-analytical, analytical, and post-analytical;
and policies and procedures should be put in place
for relevant areas of the total testing process. This
article is the first in a two part series that will
breakdown QA into the specific areas outlined in
the federal code of regulations. As we go further
into the article we will see the systemic structure
that that the QA program encompasses; however it
should be noted that the purpose of the entire QA
program is to provide continuous improvement in
patient care and not necessarily for just patient
testing.
Initial probes the reader can start asking are as
simple as does the laboratory have a program that
evaluates the total testing process or does the QA
program monitor all testing sites that are involved
in the testing processes. Further follow up probes
are what corrective actions are taken when the
laboratory does identify problems, and are those
corrective actions monitored for their effectiveness.
As previously stated the significance of the QA
program is to act as an umbrella that provides the
instructions for how the laboratory will monitor the
total testing process for the purpose of providing
continuous improvement in patient care.
The first area under the QA umbrella is patient test
management. Patient test management is
separated into patient preparation, specimen
collection, and specimen handling; test requisition;
specimen rejection; test report, accuracy/reliability
of the reporting system, and reporting priorities;
and appropriate record storage and retrieval of test
results. Patient preparation, specimen collection,
and specimen handling are common pre-analytical
procedures that usually involve non-technical staff
and consequently the written procedures need to
be as specific and complete as
possible. There is no room for
allowing the staff to guess
because an accurate result
requires the proper specimen.
All areas need to be spelled
out and addressed
appropriately, not only for
a proper specimen, but
also so the laboratory
can easily monitor

this part of the QA program and make adjustments
as necessary.
The laboratory must only perform testing that is
requested by an authorized person. The request
can be in writing, electronic, or verbally; however
the laboratory must follow up with a request for
written authorization if only a verbal order is made.
The test requisition must be available to the
laboratory at the time of testing and records must
be maintained for a period not less than two years.
Having written procedures in place for the staff to
follow and doing periodical audits on patient
records as part of the QA program can help to
ensure this criteria is met.
Specimen rejection criteria must be in place and
the laboratory must be able to evaluate the criteria
and the outcome imposed by them. Usually the
laboratory will base the criteria on the testing
manufacturer guidelines for proper specimen type,
volume, etc. However there are other criteria that
need to be put in place such as proper sample to
patient identification or specimen age. The
laboratory needs to take all factors into account
and document them properly for continued follow
up as part of the QA program.
The test report (final report) must be sent to the
individual that is responsible for using the test
result(s). It must be provided in a timely and
confidential manner. The laboratory must be able to
produce an exact duplicate for specific periods of
time depending on the methodology, state or local
guidelines, or accreditation agency. In the event
laboratories have multiple sites there needs to be a
system in place that identifies which test was
performed at which location. Normal, or reference,
ranges must be available to the ordering individual.
There are other methods of providing this to them;
however usually these are included on the final
report for ease of interpretation. The laboratory
also needs to have a procedure in place that
provides instructions for reporting panic values.
Imminent life-threatening results must be
immediately given to the test requester.
Record retention is a process of storage and
retrieval of test results. The retention must include
the identification of the testing personnel that
performed the procedure. Also, the record retention
must include appropriate patient identification,
date and time of specimen receipt, and the
condition or disposition of specimens that do not
meet criteria for acceptability. Just like the test
report, record retention is for a specific period of
time that depends on the methodology, state or
local guidelines, or accreditation agency.
The second area under the QA umbrella is Quality
Control (QC). This is a system that will help to
detect errors in the test system, environmental
condition, or from the operator. Most accreditation
agencies put further requirements on this area than
what is minimally accepted by CLIA; however the
basic idea of QC is to help ensure accurate patient
results. Sec. 493.1256 Standard Control
procedures state: (a) For each test system, the
laboratory is responsible for having control
procedures that monitor the accuracy and precision
of the complete analytical process. (b) The
laboratory must establish the number, type, and
frequency of testing control materials using, if
applicable, the performance specifications verified
or established by the laboratory as specified in Sec.
493.1253(b)(3). This article will not go as deep as
to list all the QC requirements; however the reader
should have a clear understanding that the
laboratory needs to document all QC activity and
take the appropriate action when the QC does not
perform as expected and there needs to be a
mechanism in place that evaluates and reviews the
effectiveness of corrective actions.
The assessment of QC also includes the evaluation
of patient data for reference range verification. The
rules do allow for the laboratory to use the
manufacturer established range provided it is
appropriate for the population; however the
laboratory still needs to evaluate their own data to
confirm the manufacturer’s claim of normal ranges.
The rule uses wording that is a little vague in
regards to how many samples should be reviewed
in confirming the claim so the laboratory should
establish a process that will provide statistically
significant data based on the availability of results.
In the event the manufacturer has not established
ranges the laboratory is allowed to utilize published
ranges; however they still must evaluate their own
data in order to support the published ranges.
The laboratory must also monitor for errors in the
post analytic reported results. This can take many
forms such as reviewing LIS manually entered
results, review of supervisory result logs,

intermittent testing of instrument host
communications with the laboratory interfacing
system, etc. Erroneously reported results would
need corrective actions and follow up review to be
sure the problem has been corrected appropriately.
With review of the corrective action documentation
as part of the QA program the laboratory can
assess if there is a need for further action(s) and
how to institute them.
The next area of the QA program includes
proficiency testing assessment and follow up
corrective action. As the guidelines state
laboratories must enroll in an approved proficiency
testing program and the laboratory must authorize
the release of results. The significance of
proficiency testing is to provide the laboratory with
an extra measure of self-assessment. When the
unknown samples are tested they should be treated
identically as patient samples. This means the
samples should be included into the routine
workload and should not be repeated more than
the laboratory would repeat a routine patient
sample. Also there can be no inter/intra-laboratory
discussion until after the results have been
released by the proficiency testing program. In the
event part of the in-house testing on a normal
routine patient would require that sample go on for
further studies to a reference lab, the laboratory
would end the testing at this point and report their
results up to what is done in-house.
When the submitted results are graded and
correlated with the peer group the laboratory must
follow up with unsuccessful or unsatisfactory
results. The laboratory should investigate why the
result they submitted was outside of the acceptable
range, or value, and determine a course of action
to prevent the erroneous result from happening
again. Common errors are as simple as submitting
the result(s) in the wrong units or inaccurately
moving the decimal place; however these are the
same type of error that can take place with a
routine patient and appropriate follow up would
need to be done to ensure that patients were not
also resulted with a common error. More involved
investigations require participation from the testing
system manufacturer and could require the
laboratory cease testing until the problem can be
resolved. All actions taken need to be documented
and further follow up to ensure the corrective
action has remedied the problem.
When the follow up has determined the initial
corrective action did not resolve the issue or
problem the laboratory must then take further
action to remedy the problem. Examples could be
simply retraining of the testing personnel; however
if part of the process is the malfunction then
retraining most likely would not fix the problem
and the laboratory would then need to review the
process and determine where the breakdown is. If
the process is acceptable and the testing personnel
are not the issue then possibly the problem could
be with the tools utilized by the testing personnel
during the process. Examples could be pipettes,
mixers, centrifuges, etc. Regardless of what the
issue is the laboratory needs to document the
corrective action and follow up with further review
to ensure the problem is resolved.
Occasionally the laboratory will face issues that
would require alternative means of proficiency
material. Examples can be unavailability of a
certain analyte from the manufacturer or a
depleted supply of material from the vendor.
Regardless of the issue this does not exclude the
laboratory from preforming proficiency testing. The
laboratory would need to contact another vendor
for material or in cases were the laboratory was
unable to retrieve the supply the laboratory can
perform what is called a split sample study. The
laboratory would test samples blindly with another
laboratory and compare the values. The laboratory
would then either approve the comparison or
institute follow up corrective action to remedy
issues. Again, all corrective action would require
proper documentation and follow up review to
prevent any issues from arising again in future.
The QA program must also include comparison of
test results. This criteria involves laboratories that
use different methodologies, instruments, or
performs testing at multiple sites. The laboratory
must have a system in place that will evaluate the
results at least twice a year. The significance of this
criteria is to show that regardless of what testing
system the laboratory performs the test on; the
final results will be reliable to the individual
treating the patient. The most common method
used by laboratories is the split sample studies.
Very similar to the split sample study a laboratory
would use to satisfy proficiency testing under
certain circumstances, the laboratory would use

this method also to compare its different
methodologies or instruments.
The data evaluation can take different forms of
statistical data such as a slope review, linear
regression, etc. Regardless of how the data is
reviewed the laboratory must have a system that
defines the relationship of the testing systems
and the proper documentation for corrective
action must be in place. Again, the corrective
action taken must be followed up on to ensure the
action taken corrected the problem.
Non-regulated analyte(s) are also included in the
test comparison criteria. Regulated analyte(s) are
listed as specific tests for which PT enrollment is
mandatory. Non-regulated are analytes that are
not specifically listed in the regulation. The
criterion is for non-regulated to be evaluated for
accuracy and reliability at least twice a year. This
can be performed in a similar way as the split
sample study where the laboratory can compare
results blindly with another laboratory and the
results would be compared for acceptability. Any
corrective action taken would be documented and
followed up for review by the laboratory to
prevent the issues from arising in the future.
To recap the QA program so far we will review
what has been discussed and provide probes the
laboratory can use to help define their needs. For
patient test management the laboratory would
want to start by asking itself; does the client have
the necessary information to collect and submit
specimens, does the laboratory have established
turnaround times, and how are abnormal/panic
values reported? The laboratory would then want
to probe its test reporting mechanism and its
record retention/storage process. For quality
control the laboratory needs to ask itself; how it
evaluates action taken to correct QC and did
those actions prevent future testing problems?
Further probing are; how did the laboratory
evaluate the reference range for the methodology
and what action is taken for identified errors in
the reported results? For proficiency testing the
laboratory should probe the corrective actions
that were taken for failures. If the actions taken
were not successful were more effective actions
taken? Comparison of test results would be
probed by asking; how are the methods for the
same test monitored and does the laboratory do
an external assessment on the non-regulated
analytes?
The previous stated probes only touch on the
basics and for the limitations of this article we
will conclude with just basic probing. However
the laboratory should review further literature
that will help encompass everything needed to
complete the QA program and provide a complete
assessment. The second installment of this two
part series will go further and help the reader
understand the remainder involved in the QA
program and provide more probing the laboratory
can utilize to assess their current program. The
items covered this far in this article should help
the reader have a better understanding of how
the QA program is viewed as the umbrella for the
laboratory and to give them a way to take a
better look at themselves through internal
assessments. Also, at this point, we should
restate that QA is not a onetime process but
rather an ongoing mechanism that monitors the
total testing process.
Sources:
1. Title 42 Subpart P: Quality Assurance
493:1701 Quality Assurance Assessment
493:1703 Patient Test Management
493:1705 Quality Control Assessment
493:1707 Proficiency Testing Assessment
493:1709 Comparison of Test Results
Assessment

Calculating the Costs of
Continuing Education
By Karen Appold, freelance writer,
www.WriteNowServices.com.
Imagine using a mechanic who has not taken
any courses since the 1990s on repairing the
latest models. Would you want him working on
your car?
The same philosophy holds true for
laboratorians. As a patient, would you want
someone who was last educated on lab
technologies 20 years ago to analyze your
specimen?
That’s the analogy used by Mary Ann McLane,
PhD, MLS(ASCP)cm
professor, University of
Delaware, Department of Medical Laboratory
Sciences, Newark, when asked why continuing
education (CE) is important for the
laboratory profession. “To me, it’s
a no-brainer,” she said.
Unfortunately, not every
employer shares this mentality
when budgeting for staff CE.
Therefore, many laboratorians
face budget limitations when
striving to continue their
education. According to Elissa
Passiment, EdM, CLS(NCA),
executive vice president,
American Society for Clinical
Laboratory Science (ASCLS),
some hospital and private
sector administrators do not recognize the
value of CE.
“They view the expenditures as non-
productive,” she said. “Our profession has not
established a good case that correlates the
level of competence with the level of CE.”
Professions such as nursing that have
mandated CEs are more successful in obtaining
and retaining funds for this purpose.
While budget constraints have caused many
hospitals to withhold funding for CE, just the
opposite should occur. In times of budgetary
constraints, it is more important than ever to
ensure that employees are knowledgeable in
current procedures and testing.
It is important to stay current on testing
methods, instrumentation and clinically
relevant analytes because they constantly
change, Dr. McLane noted. For example, five
years ago mass spectrometry was used in
research but not during actual patient
specimen analysis. It’s possible that labs may
be using a poor predictor of cardiovascular
disease by focusing only on cholesterol and not
on the actual number of LDL and HDL
“packets” in the circulation. It was only since
2010 that hemoglobin A1c moved to being the
preferred method of diabetes mellitus
diagnosis rather than just being a way to
monitor the condition.
Dr. McLane believes that individuals who don’t
keep up with the literature or attend
conferences are left in the dust. “They are not
making themselves more marketable nor are
they providing themselves with the intellectual
stimulation which, I think, was what
drew many of us to this field%the
wonder of discovery about the
human body.”
Added Passiment, “As health
care providers, we are
ethically responsible to
remain competent in our
field.” The only way to
learn new information is
through education.
Making Ends Meet
So how can someone
obtain continuing education
when funds are tight? With the use of CDs and
the Internet, CE can be produced and
delivered for less of an upfront investment
than conducting meetings, publishing books
and journals, Passiment said. In addition,
electronic delivery allows individuals to access
CE at any time from just about anywhere.
Pamela Gadsby, MA, MT(ASCP), quality
assurance/continuing education coordinator,
Capital Health System, Trenton, NJ,
recommends these cost-effective methods to
obtain CEs, of which Passiment and Dr. McLane
concur:
• Acquire a CD containing CE courses.
They are available from laboratory
organizations such as the Colorado

Association for Continuing Medical
Laboratory Education Inc. (CACMLE).
• Take an online course. Some can lead to
degrees in clinical laboratory science.
• Take advantage of local ASCLS offerings,
which are either free to members or
cost a nominal fee.
• Read and take Learning Scope tests in
ADVANCE for Medical Laboratory
Professionals. This is perhaps the least
expensive method, McLane said.
• Read FOCUS articles in the Clinical
Laboratory Science journal.
• Listen to teleconferences by the
American Society for Clinical Pathology
(ASCP).
• Take in-house courses and free online
conferences offered by various
companies.
• Attend a workshop at a community
college for a nominal fee.
• Participate in the College of American
Pathologists’ audio conferences. These
are offered free of charge.
Conference Advantages
While technology has made CE more
affordable, educators still believe conferences
can be worth the cost. Dr. McLane said she still
earns a majority (about 70 percent) of her CE
credits at conferences and about 30 percent
via CDs or the Internet. Ten years ago, she
only earned 5 percent through CDs and the
Internet.
“Conferences provide the intellectual
stimulation I need to grow as a person,” Dr.
McLane emphasized. “They also provide
networking opportunities ranging from
technical problems to job placements to
knowing there’s someone out there who
speaks my language. I always leave such
experiences refreshed and renewed. People
who don’t attend are starving themselves
professionally.”
Laboratorians can learn information from
colleagues that they can’t acquire from self-
study, Passiment adds. In the book, “From
Beginning to End: The Rituals of our Lives,”1
Robert Fulghum wrote that part of the ritual of
a professional is to come together—usually at
an annual meeting—to be with people who
think like we do, talk like we do, share the
same interests and values and make us feel
good about who we are. “Attending a
professional meeting, networking with
colleagues and listening and learning from
them are part of being a professional and help
us to like who we are and what we do,”
Passiment said.
Conferences offer opportunities that other
methods of CE do not. By visiting an exhibit
hall, laboratorians can learn about new
techniques and equipment. You can attend
seminars and workshops to become familiar
with current technology, research and
development, and participate in a panel
discussion to learn about best practices.
Getting Creative
When all traditional methods to obtain funding
for CE fail, put on your thinking cap. Begin by
informing your employer that the ASCP Board
of Certification now requires 36 hours of CE
credits beginning with those laboratorians who
have passed its certification exam in January
2004, Dr. McLane noted. In addition, everyone
who became an MLS or MLT(ASCP)cm
as a
result of the merger in 2009 of the Board of
Registry (BOR) and National Credentialing
Agency for Laboratory Personnel (NCA) have
the same re-certification requirement.
Certification will lapse if 36 hours are not
documented within three years. Not meeting
that requirement could potentially place the
clinical lab in a position of breaking laws
regarding the level of individuals qualified to
perform moderate and high complexity testing.
Consider the fact that some CE opportunities
may apply to more than just laboratory
professionals, Gadsby said. For example,
Capital Health System has an in-house
management development leadership
program. Participants must acquire a certain
number of hours before completing the course.
Many laboratorians have successfully
participated in this program. The benefits are
realized in their current roles and serve as
developmental strengths as additional
responsibilities are acquired in the laboratory.
The multidisciplinary group will view a

conference offered by ASCP to fulfill their education requirements.
Other creative techniques suggested by the lab experts to continue your education on a budget
include:
• Tell your employer that if he pays for your CE, you will provide an in-service to the rest of
the lab by summarizing what you’ve learned at a conference.
• Have individuals who interact with laboratory vendors ask for donations to a CE fund.
• Offer to pay for half of a CE course.
• Offer to write an article on what you learned for the rest of the laboratory (or hospital
newsletter).
Another Consideration
Although many of today’s employers offer to pay for employees’ education, many do not. If you
are unsuccessful in your efforts to have your employer pay for your CE, find comfort in this
thought provided by Dr. McLane: Why do clinical laboratory personnel consider it to be only the
responsibility of the employer to offer payment for CE, either in time off or support for
conference fees?
“I believe it is ultimately the responsibility of the lab professional to seek out continuing
education opportunities. If you can get your employer to pay for them, wonderful! But if you
don’t, for whatever reason, that does
not take away your need to seek out
CE, even if you have to pay for it
yourself,” she said.
Reference
1. Fulghum R. From Beginning to
End: The Rituals of our Lives.
New York: Ballantine Books,
1997.

Globally Harmonized
System: the new HazCom
By Peggy Luebbert, MS, MT(ASCP), CIC, CHSP,
Healthcare Interventions Inc.
Back in 1992 at its Earth Summit, the United
Nations recognized that the classification of
chemical hazards and the labeling associated
with these chemicals was causing havoc in the
chemical industry worldwide. At that time
different countries had differing labeling
requirements, different definitions of the
hazards and different warning information. In
an age of globalization, these requirements
were barriers to trade by the manufacturers
who were required to create separate labels
and data sheets for their products, depending
on what countries they would sell their
products. To ease this dilemma, the United
Nations set out to “globally harmonize” this
information. Their goal with this endeavor was
to:
Enhance the protection of human health
and the environment by providing an
internationally comprehensible system,
Provide a recognized framework to
develop regulations for those countries
without existing systems,
Facilitate international trade in chemicals
whose hazards have been identified on
an international basis,
Reduce the need for testing and
evaluation against multiple classification
systems.
Once this framework was established,
OSHA modified the United States current
Hazard Communication Standard (CFR
1910.1200) to adopt appropriate
recommendations last year. Most of the
changes affect the manufacturers and
transporters of chemicals in the USA. The
bulk of the technical material (information
required for classifying chemicals and
creating safety data sheets) appear in the
appendices of the final rule.
However, some of these adaptions affect us
in the physician office setting. These
changes must be incorporated into the
office setting by June 2015. Areas that we
will discuss today include:
Change from Material Data Sheets to
Safety Data Sheets
Changes in hazard classifications and
the use of pictograms
Changes in required formatting of
hazard chemical labels
Required education of staff to new
changes by December, 2013
Safety Data Sheets
To standardize the information for hazard
chemicals, OSHA will be requiring the use of
the new Safety Data Sheet (SDS) format
rather than the Material Safety Data Sheets
(MSDS). The MSDS format we are all familiar
with was adopted back in 1989 and had 8
sections. The new Safety Data Sheet has 16
sections which is similar to the ISO and ANSI
MSDS/SDS format that was recommended by
these groups back in 2002. Many
manufacturers and distributors have already
converted to this style. These sections include:
Section 1: Identification includes
product identifier, manufacturer name
and address, emergency phone number,
recommended use, restrictions on use.
Section 2: Hazard(s) identification:
Classification of the chemical, includes
required label elements
Section 3: Composition /information on
ingredients, trade secret claims
Section 4: First aid measures, includes
important symptoms, effects, acute,
delayed, required treatment
Section 5: Fire fighting measures,
chemical hazards from fire
Section 6: Accidental release measures
lists suitable emergency response,
protective equipment, containment,
clean-up
Section 7: Handling and storage lists
precautions for safe handling and
storage, including incompatibilities.

Section 8: Exposure controls/personal
protection equipment including
permissible exposure limits, TLVs,
engineering controls
Section 9: Physical and chemical
properties
Section 10: Stability and reactivity
Section 11: Toxicological information,
routes of exposure, acute & chronic
effects, numerical measures of toxicity
Section 12-15 are non mandatory
according to OSHA Hazcom 2012. Other
agencies enforce this information, not
OSHA.
Section 12: Ecological Information
Section 13: Disposal considerations
Section 14: Transport information
Section 15: Regulatory information
Section 16: Other information, includes
the date of preparation or last revision
The technical materials used to classify the
hazards of individual chemicals are in the
appendices of the 2012 HazCom standard. This
is primarily for manufacturers and writers of
the SDSs. The Appendix
A on the 2012 Health
Hazard Criteria is 32
pages long whereas the
Appendix B on Physical
Hazard Criteria is 11
pages.
Labeling
All labels on hazardous
chemicals under OSHA’s
Hazard Communication
Standard (Haz Com) will
be required to have
pictograms, a signal word,
hazard and precautionary
statements, the product
identifier and supplier
identification. A sample
revised HCS label
identifying the required
label elements is shown. Supplemental
information can also be provided on the label
as needed. Labels will require the following
elements:
Pictogram: a symbol plus other graphic
elements, such as a border, background
pattern, or color that is intended to convey
specific information about the hazards of a
chemical. Each pictogram consists of a
different symbol on a white background within
a red square frame set on a point (i.e. a red
diamond). There are nine pictograms under
the GHS. However, only eight pictograms are
required under the HCS.
Signal words: a single word used to indicate
the relative level of severity of hazard and
alert the reader to a potential hazard on the
label. The signal words used are “danger” and
“warning.” “Danger” is used for the more
severe hazards, while “warning” is used for
less severe hazards.
Hazard Statement: a statement assigned to
a hazard class and category that describes the
nature of the hazard(s) of a chemical,
including, where appropriate, the degree of
hazard.
Precautionary Statement: a phrase that
describes recommended measures to be taken
to minimize or prevent adverse effects
resulting from exposure to a hazardous
Figure 1: OSHA QUICK Card: Hazard Communication
Standard Labels

chemical, or improper storage or handling of a
hazardous chemical.
Hazard Classifications and Pictograms
GHA hazard classifications adopted by OSHA
include 16 physical hazards, 10 health hazards
and environmental hazards. Global
Harmonization has standardized the
pictograms associated with these hazards.
These pictograms should be used on the labels
and SDSs of hazardous chemicals to alert
users of the hazards to which they may be
exposed. Each pictogram consists of a symbol
on a white background framed within a red
border and represents a distant hazard(s). The
pictogram on the label is determined by the
chemical hazard classification.
Employee Education
All employees who handle hazardous chemicals
must be educated to these Haz Com changes
by December 2013. OSHA has developed
“Quick Cards” which can be used as
educational materials or handouts to document
this education. It includes information sheets
on the Safety Data Sheets, Labeling and
Pictograms. These can be found at
www.osha.gov/dsg/hazcom/
ghsquickcards.html
After all is said and done with the new Global
Harmonization system, on a worldwide basis
we should expect SDS to be easier to read for
workers, that all chemicals will be included in
the system, improved safety for chemical
users, that labels will provide more safety
information, a cost savings for manufacturers
and distributors and last but not least – lives
will be saved!
References:
A Guide to The Globally Harmonized System of
Classification and Labelling of Chemicals (GHS)
http://www.osha.gov/dsg/hazcom/ghs.html.
OSHA’s web page on GHS: http://
www.osha.gov/dsg/hazcom/index.html
EPA’s web site on GHS: http://www.epa.gov/
oppfead1/international/globalharmon.htm
Figure 2: Hazard Classifications and Pictograms

ContinContinContinContinContinuing Medicaluing Medicaluing Medicaluing Medicaluing Medical
EducaEducaEducaEducaEducation (CME) Inftion (CME) Inftion (CME) Inftion (CME) Inftion (CME) Informaormaormaormaormationtiontiontiontion
AAFP-PT emphasizes the importance of
voluntary laboratory improvement and
provides all participants with the educational
benefits for total quality assurance. AAFP-PT
takes pride in offering educational programs
and reference tools for our participants.
Physicians and their staff can earn continuing
education credits for their participation, review
and/or management of the AAFP-PT
proficiency testing process in their office lab.
In order to earn the continuing education
credits, participants must also complete our
educational materials that are specifically
developed for the physician’s office lab.
Physicians are eligible to receive up to twelve
hours of Prescribed (Category 1) CME by the
American Academy of Family Physicians. AAFP-
PT is also approved as a Provider of continuing
education programs in the clinical laboratory
sciences by the ASCLS P.A.C.E.®
Program. This
is a benefit offered to all participants at no
additional cost!
CME credit is earned by reviewing the
publication and completing an online quiz. The
quiz can be accessed through the CME link on
your PT Central homepage.
Please follow the instructions below to
participate in CME Online & to obtain your
documentation:
How to Obtain CME
1. Go to www.aafp.org/pt/ptcentral . Login
using the laboratory user name and
password.
2. Click the link for CME located on the left
side of the screen
3. Use the drop-down menu to choose a
CME activity. A link to the POL Insight
will appear.
4. Follow the instructions to access the
CME Assessment.
5. Enter your personal ID number/user
name and password. This is different
than the laboratory ID number.
NOTE: First-time participants must do the
following:
a) Click “Not a member or paid
subscriber?”
b) Click “Need to create an account?”
c) Enter email address
d) If not found in system, click
“continue to register”
e) Enter personal information & click
“continue”.
f) Choose a user name & password.
Note this information for future use.
4. Click “Done”
5. Click “Enter the Site”
6. All currently active quizzes will be listed.
Choose the desired test & click “Take the
Quiz!”
How to Complete & Submit CME
1. Read the questions & click in the circle
next to the correct answers. Repeat for
all questions.
2. Click “Submit” when done
3. Review your score and click “Submit
your quiz rests”
4. Complete the post-test evaluation and
click “submit answers”
5. From the “Thank you screen” click “View
letter of participation” to obtain
documentation of your CME credits.
How to Obtain CME
Documentation (Letters of
Participation) for previous
events
1. Go to www.aafp.org/cmecertificate
2. Enter ID number or user name &
password in boxes at upper right side of
page & click on the green arrow to
enter.
3. Click “CME Proof of Participation” on left
side of screen
4. All completed CME will be listed. Click
“Print Letter” next to each event for
which you are claiming credit.
5. Submit copies of this documentation to
your accrediting agency as required.
The due dates for claiming CME credit are
strictly enforced.

The material necessary to review to answer the following questions may be found in this
issue of the P.O.L. Insight. Answers may be submitted through the CME Online link found by
clicking the CME link on the left side of your laboratory’s PT Central homepage. The
Accreditation information is located on the inside cover of this issue.
2013-A CME Questions2013-A CME Questions2013-A CME Questions2013-A CME Questions2013-A CME Questions
(Deadline for credit is February 28, 2014 - Only employees of laboratories currently
enrolled in AAFP-PT are eligible to participate in this CME activity.)
1. True or False: A written policy & procedures outlining Quality Assurance are mandated under
CLIA ‘88.
A. True
B. False
2. A comprehensive Quality Assurance program must _____________________.
A. assure accurate & timely reporting of laboratory results
B.assess personnel competency
C. identify problems in the testing process
D.All of the above
3. True or False: Quality Assurance only applies to the technical portions of laboratory testing.
A. True
B. False
4. Quality Assurance of patient test managment includes monitoring:
A. Patient preparation
B. Specimen collection & handling
C. Specimen rejection criteria
D. All of the above
5. True or False: Laboratory testing can only be performed if requested by an authorized
person.
A. True
B. False
6. True or False: Verbal authorization alone from a physician is sufficient to request a
laboratory test with no further documentation.
A. True
B. False
7. Written test requests need to be retained for at least ______ year(s).
A. 1
B. 2
C. 5
D.7

8. Specimen rejection criteria may include _______________________________.
A. Improper collection volume
B. inadequate patient identifiers
C. Both A & B
D. None of the above
9. True or False: A laboratory may use the manufacturer’s suggested reference ranges
without further validation.
A. True
B. False
10. Non-regulated analytes must be evaluated for accuracy & reliablity at least
___________________ per year.
A. once
B. twice
C. three times
D. none of the above
11. Your PT Central homepage is your source for _________________.
A. Evaluation reports
B. instrument/method verification
C. special specimen handling or testing istructions
D. All of the above
12. True or False:A laboratory may be exempted from proficiency testing requirements if PT
materials are unavailable.
A. True
B. False
13. A “skull & crossbones” chemical pictogram signifies ________________.
A. a carcinogen
B. an environmental toxin
C. acute toxicity
D. corrosive
14. True or False: Prior to 1992, all chemical classifications were standardized internationally.
A. True
B. False
15. Global harmonization of chemical standards is a project of _________________
A. World Health Organization (WHO)
B. OSHA
C. United Nations (UN)
D. None of the above
16. Under the new HazComm, all chemical lables must include _________________.
A. pictogram
B. signal word
C. product & supplier identifiers
D. All of the above

17. First aid measures for chemical exposure are found in Section _______ of the new
Hazcomm.
A. 1
B. 3
C. 4
D. 8
18. True or False: The majority of changes to the HazComm apply to chemical manufacturers
& shippers, not the laboratory.
A. True
B. False
19. True or False: The Material Safety Data Sheet (MSDS) format in being phased out &
replaced with the Safety Data Sheet (SDS).
A. True
B. False
20. A chemical label pictogram image is _____________________.
A. Red with a white border
B. White with a red border
C. Yellow with a black border
D. White with a black border
21. True or False: “Warning” as a signal word conveys a greater degree of hazard than
“Danger”.
A. True
B. False
22. Employee training on the new HazComm must be completed by ____________.
A. December 2013
B. January 2014
C. June 2014
D. June 2015
23. True or False: It is the responsibility of the employer to provide support for an employee’s
CME activities.
A. True
B. False
Go to
the Online CME link in
PT Central
to take this quiz
and receive CME credit.

24. True or False: Sharing knowledge gained through a CME activity by providing in-services
or writing an article can be an effective way to maximize CME expenditures.
of water.
A. True
B. False
25. True or False: Failure to mainain certification through CME may result in a laboratory’s
failure to comply with CLIA requirements for moderate/high complexity testing.
A. True
B. False
26. ASCP-certified laboratorians must document earned CME every ___________ year(s).
A. 1
B. 3
C. 5
D. 7
27. True or False: Visiting a conference vendor exhibition hall is a valuable way to assess new
technology.
A. True
B. False
28. ASCP certification for laboratorians now requires ________ hours of CME.
A. 10
B. 22
C. 36
D. 50
29. True or False: Attendance at conferences provides opportunities for networking in
addition to obtaining CME.
A. True
B. False
30. Low-cost options for obtaining CME include _______________.
A. professional magazines
B. online courses
C. teleconferences or webinars
D. All the above

POL_INSIGHT_2013_A

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