Proficiency Testing in US Clinical Laboratories: Percept

Association of Public Health Laboratories, Inc.
Informed Consent

Form Approved  
OMB No. 0920­XXXX  
Exp. Date XX/XX/20XX  
Purpose of the Study: This survey is being performed for the Centers for Disease Control and Prevention (CDC) and the Association of Public 
Health Laboratories (APHL) to understand how laboratories use proficiency testing (PT) and how they perceive its value. This survey will take 
approximately 20 minutes to complete. 
Incentive for Participating: If you wish, by providing your email address, you will be entered in a drawing for a webinar training session on a 
current laboratory topic. Within 60 days of the closing date of the survey, a random drawing will be held using those email addresses. Winners will 
be notified via email. 
Security Information: All information collected in this survey will be kept in a secure manner. No individual answers will be shared with CDC or 
APHL. We ask you to include your unique identifier provided in the survey recruitment letter (or your CLIA certificate number) so that we can 
connect your survey answers to demographic data that are already on file and to ensure that only one response per laboratory is received. Your IP 
address will NOT be retained. 
If you would like to be entered in the drawing to receive free webinar training, at the completion of the survey we will request your email address so 
that we can notify you if you win. However, your email address will not be linked with data from your survey. The list of email addresses will be 
stored electronically in a password protected file and will only be used to randomly select the raffle winners. After the drawing, that file will be 
deleted. 
Decision to quit at any time: Participation is voluntary; you are free to withdraw from this survey at any time and you may choose to skip any 
questions that you do not wish to answer. The number of questions you answer will not affect your chances of winning one of the webinar trainings. 
If at any point you do not want to continue, you can simply leave this website. If you do not click on the “submit" button at the end of the survey, 
your answers and participation will not be recorded. 
How the findings will be used: The results from the study will be compiled and shared in aggregate as a learning tool, presented at professional 
conferences, and potentially published in a professional journal in the field of laboratory science. 
Contact information: If you have concerns or questions about this study, please contact [email protected] using the subject line “PT survey.” 
Agreement: By clicking the NEXT button and beginning the survey, you acknowledge that you have read this information and agree to participate 
in this survey, with the knowledge that you are free to withdraw your participation at any time without penalty. 
Public reporting burden of this collection of information is estimated to average 20 minutes per response, including the time for reviewing 
instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of 
information. An agency may not conduct or sponsor, and a person is not required to respond to a collection of information unless it displays a 
currently valid OMB control number. Send comments regarding this burden estimate or any other aspect of collection of information, including 
suggestions for reducing this burden to CDC/ATSDR Information Collection Review Office, 1600 Clifton Road NE , MS D­74, Atlanta, Georgia 

30333; ATTN: PRA (0920­XXXX). 

Welcome

Thank you for taking the time to complete this survey by the Association of Public Health Laboratories (APHL) in 
collaboration with the Centers for Disease Control and Prevention (CDC). Your feedback is important for guiding APHL 
Other 
and CDC in their efforts to understand how proficiency testing (PT) is used in clinical laboratories. The survey should 
take approximately 20 minutes of your time. All answers will remain completely anonymous. 

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Association of Public Health Laboratories, Inc.
For the purpose of this survey, “proficiency testing” means a Centers for Medicare and Medicaid Services (CMS), approved commercial program that 

grades your responses and tells you whether you passed or failed each challenge. Click here for a list of PT programs. This list will open in a 
separate window. 

*1. Please enter the 8­digit number that can be found on the address label of the survey

announcement OR the 10­digit CLIA number for your laboratory as indicated on the CLIA
certificate. Please note: an independent contractor will use these numbers to assure that
there is only one response per laboratory and to characterize the demographics of survey
respondents. No government agency (local, state or federal) will have the ability to identify
any individual laboratory nor have access to responses submitted.

Please indicate whether you entered the number on the invitation address label or your

laboratory's CLIA number.
j Number on invitation address label
k
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n
j CLIA number
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n

Three Phases of Laboratory Testing

Questions 2­9 will relate to the Three Phases of Laboratory Testing: 
Other 

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Association of Public Health Laboratories, Inc.
2. Which of the following steps are taken in your laboratory to process PT samples from
the time they are received until the time results are reported to the PT program? (Check all
that
Other  apply).
Pre­Analytically, our laboratory:
c Disguises the PT specimen to appear to be a patient sample
d
e
f
g

c Enters the PT specimen into the laboratory information system
d
e
f
g

c Examines and evaluates the condition of the specimen when received
d
e
f
g

Analytically, our laboratory:
c Performs preventive maintenance on instruments to be used for PT analysis immediately prior to testing, even when not required
d
e
f
g
c Recalibrates instruments to be used for PT analysis immediately prior to testing
d
e
f
g

c Repeats questionable PT results according to established criteria for repeating patient samples
d
e
f
g
c Tests the specimen in more than one run and averages results
d
e
f
g

c Tests the specimen multiple times within one run and averages the results
d
e
f
g
c Tests the specimen with the same frequency as a patient sample
d
e
f
g

Post­Analytically, our laboratory
c Discards PT samples immediately after analysis
d
e
f
g

c Discusses PT results with another laboratory for verification before reporting results to the PT program
d
e
f
g
c Retains PT samples for future use after reporting results to the PT program
d
e
f
g

c Sends PT samples to another laboratory for additional testing to confirm the PT result
d
e
f
g

c Sends PT samples to another laboratory for additional testing when our standard operating procedure requires referral for patient testing
d
e
f
g

3. How does your laboratory determine which staff employee performs PT? (Check all that
apply).
c PT is performed by the staff member performing the patient testing on that day
d
e
f
g
c PT is performed by the most experienced staff member
d
e
f
g
c PT is systematically rotated among staff on all shifts
d
e
f
g
c Other (please specify):
d
e
f
g

Pre­Analytic Phase

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Association of Public Health Laboratories, Inc.
4. Does your laboratory use PT to identify problems that may occur during the pre­analytic
phase of laboratory testing?

j Yes
k
l
m
n
j No
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n

Pre­Analytic Phase

5. For the pre­analytic problems listed below, please tell us how important PT is in
identifying them.
Not Important

Potentially Important

Important

Not Applicable

j
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m
n

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n

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j
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Mislabeled samples

j
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n

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n

j
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j
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n

Personnel competency

j
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n

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n

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n

j
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Delayed processing of 
samples
Determination of 
insufficient quantity of 
samples needed for testing
Identification of improperly 
transported samples
Inappropriate specimen 
handling, including 
dispensing
Inappropriate storage of 
samples

Other (please specify): 

Analytic Phase

6. Does your laboratory use PT to identify problems that may occur during the analytic
phase of laboratory testing?

j Yes
k
l
m
n
j No
k
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m
n

Analytic Phase

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Association of Public Health Laboratories, Inc.
7. For the analytic problems listed below, please tell us how important PT is in identifying
them.
Not Important

Potentially Important

Important

Not Applicable

Calibration errors

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n

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n

j
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n

Imprecision (result 

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Instrumentation problems

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n

Specimen dilution errors, if 

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variability)
Incorrect test reagent 
storage

applicable to method
Specimen extraction errors, 
if applicable to method
Other (please specify): 

Post­Analytic Phase

8. Does your laboratory use PT to identify problems that may occur during the post­
analytic phase of laboratory testing?

j Yes
k
l
m
n
j No
k
l
m
n

Post­Analytic Phase

9. For the post­analytic problems listed below, please tell us how important PT is in
identifying them.
Not Important

Potentially Important

Important

Not Applicable

j
k
l
m
n

j
k
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m
n

j
k
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n

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n

Incorrect calculations

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n

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n

Incorrect test result 

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n

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Delayed reporting to PT 
program

interpretation
Sending tests to the wrong 
reference laboratory for 
confirmatory testing
Transcription errors
Other (please specify): 

Page 5

Association of Public Health Laboratories, Inc.
10. To what degree does your laboratory benefit from performing PT for each of the
following aspects?
Educational:
Can be used as a means of 

Not Beneficial

Beneficial

Very Beneficial

Not Applicable

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n

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Not Beneficial

Beneficial

Very Beneficial

Not Applicable

j
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n

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staff competency 
assessment
Opportunity to identify 
educational areas needing 
improvement
Opportunity to obtain 
performance feedback from 
programs that offer PT
Provides a source of 
continuing education

Technical:
Ability to support 
confirmation of suspected 
analytical trends and/or 
imprecision
Comparison of performance 
with other participating 
(peer) sites
Instrument comparison 
before purchase
Onsite performance 
evaluation of newly 
implemented assays
Regular, external check on 
quality of testing
Troubleshooting assays 
(identifying and fixing 
problems)
Use information in PT 
summary reports to support 
recommendations to 
managers for methodology 
or instrument changes
Verification of assay 
performance to meet 
clinical needs

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Association of Public Health Laboratories, Inc.
11. How much of a challenge are the following aspects of performing PT to your
laboratory?
Not Challenging

Challenging

Very Challenging

Not Applicable

j
k
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m
n

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n

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Cost for panel analytes that 
are not currently being 
assayed in your laboratory
Commercially unavailable 
analytes (analytes for which 
PT does not exist)
Inability to truly treat PT 
samples as patient 
specimens
Large number of ungraded 
challenges
Matrix problems (interfering 
substances in sample) 
prevent comparison across 
all methods (i.e., limited to 
method peer groups)
PT program subscription 
cost
PT programs lag behind 
advancing technology in 
laboratory testing
Staff time involved in the 
PT process (i.e., 
purchasing, analyzing 
and/or interpreting)
Time required to receive 
results from PT programs

12. If your laboratory has multiple analyzers available to conduct testing for a given
analyte, how do you choose which analyzer to use for PT?
j PT is conducted on the analyzer used for routine patient specimen analysis that day
k
l
m
n

j PT is conducted on an analyzer pre­determined to have the best analytical performance whether routine specimen analysis is performed 
k
l
m
n
on that analyzer or not 

j PT is conducted on the analyzer which is least expensive to operate
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n
j PT is rotated among analyzers
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n

j Not applicable – Laboratory only has one analyzer for all tests
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n
j Other (please specify):
k
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n

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Association of Public Health Laboratories, Inc.
13. CLIA requires PT for only a limited number of tests or analytes. Click here for a list of
those analytes.This will open in a separate window. How do you meet the requirements to
verify the accuracy of any test or procedure you perform when PT is not required by CLIA
regulations or your accreditation agency for that analyte or test? (Check all that apply).
c PT is purchased for at least some non­CLIA analytes
d
e
f
g

c Patient specimens are split and analyzed in our laboratory or by a reference or peer laboratory inside our laboratory/hospital laboratory 
d
e
f
g
system and results compared 

c Patient specimens are split, a specimen is sent to a reference or peer laboratory outside our laboratory/hospital laboratory system for 
d
e
f
g
analysis and results are compared with our results 

c Performance is verified by analysis of quality control materials with established acceptance ranges
d
e
f
g
c PT is required by our accreditation organization even if it is not required by CLIA
d
e
f
g
c Test results are compared among staff within the laboratory
d
e
f
g
c No action taken when commercial PT is unavailable
d
e
f
g
c Not applicable to our laboratory
d
e
f
g
c Other (please specify):
d
e
f
g

14. When PT results are not graded by the PT program due to lack of consensus or for
some other reason, what steps do you take in your laboratory as a substitute? (Check all
that apply).
c Split patient specimens and analyze them in our laboratory or by a reference or peer laboratory inside our laboratory/ hospital laboratory 
d
e
f
g
system and compare results 

c Split patient specimens, send a specimen for analysis by a reference or peer laboratory outside our laboratory/hospital laboratory system 
d
e
f
g
and compare result with our result 

c Reanalyze residual PT material from a previously graded event
d
e
f
g

c Compare your result, when possible, with the majority in your peer­group, even if PT was not graded
d
e
f
g
c This situation has not occurred in our laboratory
d
e
f
g
c Take no action regarding proficiency testing
d
e
f
g
c Other (please specify):
d
e
f
g

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Association of Public Health Laboratories, Inc.
15. Do you purchase PT modules for some analytes or tests even when CLIA does not 
require it?
j No
k
l
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n

j Yes, we purchase for 1 ­ 5 analytes
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n

j Yes, we purchase for 6­ 10 analytes
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n

j Yes, we purchase for 11 – 20 analytes
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n
j Yes, we purchase for >21 analytes
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n

16. How important are the following reasons for purchasing PT that is not required by
CLIA?
Our accreditation 

Not Important

Potentially Important

Important

Not Applicable

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n

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n

j
k
l
m
n

j
k
l
m
n

j
k
l
m
n

j
k
l
m
n

j
k
l
m
n

j
k
l
m
n

j
k
l
m
n

j
k
l
m
n

j
k
l
m
n

j
k
l
m
n

j
k
l
m
n

j
k
l
m
n

j
k
l
m
n

organization requires us to 
perform PT
Our medical director or 
laboratory director requires 
us to perform PT
PT is used to assess 
instrument performance
PT is used to test 
competency of testing 
personnel
PT is used to track accuracy 
of methodology
PT provides a source of 
continuing education
PT results are valuable for 
identifying problems
Used as a marketing tool
Other (please specify): 

Page 9

Association of Public Health Laboratories, Inc.
17. How helpful would the following actions be to improve PT?
Not Helpful

Helpful

Very Helpful

Not Applicable

j
k
l
m
n

j
k
l
m
n

j
k
l
m
n

j
k
l
m
n

j
k
l
m
n

j
k
l
m
n

j
k
l
m
n

j
k
l
m
n

j
k
l
m
n

j
k
l
m
n

j
k
l
m
n

j
k
l
m
n

j
k
l
m
n

j
k
l
m
n

j
k
l
m
n

j
k
l
m
n

j
k
l
m
n

j
k
l
m
n

j
k
l
m
n

j
k
l
m
n

j
k
l
m
n

j
k
l
m
n

j
k
l
m
n

j
k
l
m
n

j
k
l
m
n

j
k
l
m
n

j
k
l
m
n

j
k
l
m
n

j
k
l
m
n

j
k
l
m
n

j
k
l
m
n

j
k
l
m
n

j
k
l
m
n

j
k
l
m
n

j
k
l
m
n

j
k
l
m
n

j
k
l
m
n

j
k
l
m
n

j
k
l
m
n

j
k
l
m
n

Provide less PT challenges

j
k
l
m
n

j
k
l
m
n

j
k
l
m
n

j
k
l
m
n

Provide more frequent PT 

j
k
l
m
n

j
k
l
m
n

j
k
l
m
n

j
k
l
m
n

j
k
l
m
n

j
k
l
m
n

j
k
l
m
n

j
k
l
m
n

j
k
l
m
n

j
k
l
m
n

j
k
l
m
n

j
k
l
m
n

j
k
l
m
n

j
k
l
m
n

j
k
l
m
n

j
k
l
m
n

j
k
l
m
n

j
k
l
m
n

j
k
l
m
n

j
k
l
m
n

Decrease the time allowed 
to perform PT from receipt 
of samples to reporting 
results
Increase the time allowed 
to perform PT from receipt 
of samples to reporting 
results
Increase the use of digital 
images instead of slides or 
photographs
Increase the use of slides or 
photographs instead of 
digital images
Improve the quality of 
photographs
Improve PT reporting unit 
consistency
Standardize the PT 
reporting format
Improve technical 
feedback/advice from PT 
program
Improve PT program 
customer service
Provide more PT 
challenges

events
Provide less frequent PT 
events
Provide faster return of 
results from PT programs
Provide more case study 
oriented challenges
Provide samples that better 
simulate patient specimens
Other (please specify): 

Page 10

Association of Public Health Laboratories, Inc.
18. How important are the following resources with respect to providing information about
PT results, testing, and training?
Not aware of this 

Not Important

Potentially Important

Important

Not Applicable

j
k
l
m
n

j
k
l
m
n

j
k
l
m
n

j
k
l
m
n

j
k
l
m
n

j
k
l
m
n

j
k
l
m
n

j
k
l
m
n

j
k
l
m
n

j
k
l
m
n

j
k
l
m
n

j
k
l
m
n

j
k
l
m
n

j
k
l
m
n

j
k
l
m
n

j
k
l
m
n

j
k
l
m
n

j
k
l
m
n

j
k
l
m
n

j
k
l
m
n

j
k
l
m
n

j
k
l
m
n

j
k
l
m
n

j
k
l
m
n

j
k
l
m
n

j
k
l
m
n

j
k
l
m
n

j
k
l
m
n

j
k
l
m
n

j
k
l
m
n

j
k
l
m
n

j
k
l
m
n

j
k
l
m
n

j
k
l
m
n

j
k
l
m
n

j
k
l
m
n

j
k
l
m
n

j
k
l
m
n

j
k
l
m
n

j
k
l
m
n

j
k
l
m
n

j
k
l
m
n

j
k
l
m
n

j
k
l
m
n

j
k
l
m
n

Scientific publications

j
k
l
m
n

j
k
l
m
n

j
k
l
m
n

j
k
l
m
n

j
k
l
m
n

Teleconferences

j
k
l
m
n

j
k
l
m
n

j
k
l
m
n

j
k
l
m
n

j
k
l
m
n

Web searches

j
k
l
m
n

j
k
l
m
n

j
k
l
m
n

j
k
l
m
n

j
k
l
m
n

Other laboratory 

resource

professionals inside the 
laboratory
Other laboratory 
professionals outside your 
laboratory
Centers for Disease Control 
and Prevention (CDC) 
publications and online 
resources
Clinical Laboratory 
Improvement Amendments 
(CLIA) Proficiency Testing 
brochure available from the 
Centers for Medicare & 
Medicaid Services (CMS)
CLSI GP27 – “Using 
Proficiency Testing to 
Improve the Clinical 
Laboratory”
CLSI GP29 – “Assessment 
of Laboratory Tests Where 
Proficiency Testing is Not 
Available”
CMS surveyors or 
Accreditation Organization 
Inspectors
Educational Modules 
provided by the PT 
Program
Professional organization 
newsletters

Other (please specify): 

19. Does your laboratory perform microbiology testing in your laboratory?

j Yes
k
l
m
n
j No
k
l
m
n

Page 11

Association of Public Health Laboratories, Inc.
20. Does your laboratory report PT results for microbiology to the same level as reported
for your patient testing? For example, if you report patient samples for a particular
organism to species level, do you report PT results the same?

j Yes
k
l
m
n

j Yes, but will report to a lower level occasionally
k
l
m
n

j Sometimes report PT at a higher level than patient samples
k
l
m
n
j No
k
l
m
n

21. Which of the following elements of the patient demographics or history provided with a
PT challenge are needed to process and analyze PT samples appropriately? (Check all
that apply).
c Age
d
e
f
g
c Sex
d
e
f
g

c Specimen source/type/site
d
e
f
g
c Symptom(s)
d
e
f
g

c Gram stain reaction
d
e
f
g

22. According to CLIA regulations microbiology does not have analytes, should changes
be made to microbiology PT grading to allow for monitoring performance over time on a
particular type of test or examination – for example, culture, or susceptibility testing?
j Yes, provide scores for each PT test
k
l
m
n
j No
k
l
m
n

Page 12

Association of Public Health Laboratories, Inc.
23. How important would the following be to improve microbiology PT?
Not Important

Potentially Important

Important

Not Applicable

j
k
l
m
n

j
k
l
m
n

j
k
l
m
n

j
k
l
m
n

j
k
l
m
n

j
k
l
m
n

j
k
l
m
n

j
k
l
m
n

j
k
l
m
n

j
k
l
m
n

j
k
l
m
n

j
k
l
m
n

j
k
l
m
n

j
k
l
m
n

j
k
l
m
n

j
k
l
m
n

j
k
l
m
n

j
k
l
m
n

j
k
l
m
n

j
k
l
m
n

j
k
l
m
n

j
k
l
m
n

j
k
l
m
n

j
k
l
m
n

j
k
l
m
n

j
k
l
m
n

j
k
l
m
n

j
k
l
m
n

j
k
l
m
n

j
k
l
m
n

j
k
l
m
n

j
k
l
m
n

j
k
l
m
n

j
k
l
m
n

j
k
l
m
n

j
k
l
m
n

j
k
l
m
n

j
k
l
m
n

j
k
l
m
n

j
k
l
m
n

j
k
l
m
n

j
k
l
m
n

j
k
l
m
n

j
k
l
m
n

j
k
l
m
n

j
k
l
m
n

j
k
l
m
n

j
k
l
m
n

Improve the quality of 
photographs
Improve the quality of 
stained slides
Include more susceptibility 
testing challenges
Include less susceptibility 
testing challenges
Include more emerging or 
less common organisms
Include fewer emerging or 
less common organisms
Increase the use of digital 
images instead of slides or 
photographs
Increase the use of slides or 
photographs instead of 
digital images
Require direct antigen 
testing in mycology
Require direct antigen 
testing in parasitology
Require susceptibility 
testing in mycology
Require susceptibility 
testing in virology

24. When you consider the benefits of performing proficiency testing as compared to its
costs, would you characterize it as…
j Clearly worth the costs
k
l
m
n

j Somewhat worth the costs
k
l
m
n
j Neutral
k
l
m
n

j Somewhat more costly than its value
k
l
m
n
j Clearly more costly than its value
k
l
m
n
j No opinion
k
l
m
n

Page 13

Association of Public Health Laboratories, Inc.
25. Do you have an opinion or observation about PT that you would like to share that was
not addressed in the survey?
5
6  

26. Please provide your e­mail address so that we can notify you if you win the
teleconference training. This is optional, but you cannot be entered in the drawing if an
email is not provided.
e­mail:

Page 14