Technical Competency Exam

2015
This exam is based on COLA technical body of knowledge and is open
book. Please use your CCI and other materials that you normally use
when performing a survey or answering technical questions, but please
do not discuss with other technical staff. Everyone needs to do their
own work. When the questions asks How would you handle this
situation?, respond with the criteria or criterion that is out of
compliance with COLA. If you are a surveyor and you cite a question,
also include your surveyor comments. If you are not a surveyor, include
what you would expect to see as a surveyor comment. Please do not
write your answers in RED. This makes it very hard to grade. Please
take your time and Good Luck! Thanks
Name: Pam Gottsponer
Date Completed: 1/15/2016
Score: 97.9 % Knocked it out of the park!!
Graded by: Edward A Sass
Signature of grader:

1. List the 5 types of CLIA certificates. Which one(s) should you

NEVER see in a COLA lab and why? (5 points) PPMP, COA, COC,
COR, COW.
You should never see a COC (Certificate of Compliance), as this
indicates that CMS, the state is doing their survey. OK

2. What are ALL the possible combinations (Pass and Fail) of

proficiency testing results/failures that would put a lab at cease
testing for that test? Example F-F-F. (2 points)
FFF, FPFF, FFPF, FPFPF Good

3. This COLA laboratory performs urine colony counts. The lab

streaks a Blood Agar/EMB biplate with 0.001 ml calibrated loop.
The plate is incubated overnight at 35C and the colonies are
enumerated. The results are reported out CFU/ml. An inspection
of the laboratory records and reports shows that No Growth is
reported when no colonies are found. Please answer the
following: ( 3 points)
What is the complexity of this test?
Moderate Good
Is proficiency testing required for this test? Why or why not?
Yes, because by reporting no growth it is no longer considered
a colony count and the lab is now required to perform PT. Good
4. This long standing COLA lab did not notify COLA when they
switched from MLE to API in 2014. Subsequently they had 3
unsatisfactory scores, one each for Hematocrit, Uric Acid and Free
T4. There were no QIP-1 letters in Doc Linc as COLA was not
receiving their PT results. What citations, if any, are warranted
for this lab and why? (5 points)

Org 3, must notify COLA of changes, PT1COLA is required by CMS to

monitor labs PT, and if we arent notified of the change we are unable
to monitor them, LDR4---should have identified this, Per4cshould
have identified this, QA 3QA plan should have identified this error.
OK. We will discuss this one in future training session.
5. Fill in the blanks for the 5 day, 3 replicate studies performed to
reduce QC requirements from daily to weekly for susceptibility
testing. Indicate in your answers what the lab needs to do next (4
points).
The lab tested 3 replicates each of QC strain for day using
individually prepared inoculum;
a. 0-1 results of the 15 were out of range. What is the result?
Pass, may convert to weekly QC. OK
b. 2-3 results of the 15 were out of range. What is the result?
Test another 3 replicates for 5 days. If that passes (2-3 out
of 30), then may convert to weekly QC, if not (>or equal to
4 out of 30), then it is a failure, and must stay with QC each
day of testing. Additionally corrective action must be
performed to identify problem. Good
c. 4 or more results of the 15 were out of range. What is the
result?
Fail-- continue to perform QC each day of testing and perform
corrective action. good
6. What is required from a laboratory if they are cited for the same
question on successive surveys? (2 points)

Documentary response is required whether it was originally a

documentary citation or not. Good

7. Please answer the following concerning Calibration Verification. (6

points)
When would calibration verification be required on the analyte
Sodium? When the calibration curve has less than 3 calibrator
points. Good
What is the minimum frequency of calibration verification? Every
6 months. Good
What is the minimum number of samples required to perform
calibration verification? 3, low, mid, and high in the reportable
range. Good

8. What is the maximum number of non-waived labs that a Lab

Director can direct in the state of Georgia? (2 points) 3 labs Yes
9. ( 1 point) IQCP is optional? True or False True, it is optional Yes
10.
What are the requirements for a throat culture (to detect of
Group A Streptococcus) to be moderate complexity? (3 points)
Strep Select Media, 0.04 bacitracin disc, no subculture, and no
direct testing from media. Excellent

11.
While performing your walk-through during a survey you
notice that the controls for the Immulite are being stored in a
freezer with a range of -15C or colder. The Immulite control
package insert states the storage range is to be -20C or colder.
The freezer temperature varies between -15C to -18C on a daily
basis. How would you handle this situation? ( 3 points)
Cite MA 2not stored as directed.
Surveyor comment--The manufacturer states that Immulite reagents should be
stored at -20 C or greater. The freezer where the controls were stored
consistently read between -15 C and -18 C. Good

Cite MA 14acceptable range for freezer is in error.

Surveyor comment-- Although ranges had been established and documented for
the freezer temperatures, they did not reflect the acceptable ranges of the
reagents/controls stored in the freezer. Good

QA 3Cite that QA plan did not pick this up and have them document
an investigation (info from manu) as to effect on storing at <-20 C.
Surveyor comment--Although this lab has a QA Plan in place, it has been
ineffective in identifying that Immulite reagents were being stored
inappropriately. Submit documentation of resolution of this issue.

I would say QA 3 is optional. I agree that a good QA plan should pick

up on any issue. Surveyor choice.

12.
You are reviewing a laboratorys IQCP. You notice that the
Lab Director has delegated in writing the implementation of the
IQCP to the qualified technical consultant. The documents seem
to be in very good order. The final IQCP was signed prior to
implementation by only the technical consultant. How would you
handle this situation? (3 points) Educate, cite QC 31.3 and
document back.
Surveyor comments: The lab director must review and approve each
IQCP plan prior to implementation.
Submit documentation of the review and approval by the lab director
for each IQCP plan in place in this laboratory. Good
13.
What is Matrix Effect? Measurement of the matrix effect
(ion suppression) is the ratio of the peak area of target analyte
in urine spiked post SPE to its peak area in spiked mobile phase.
How do Mass Spectrometry labs normally correct for matrix
effect in urine drug confirmation laboratories? (4 points) By using
an internal standard, generally a deuterated version of the analyte
tested. IS contained in all samples, controls and calibrators. 0.5
points
14.
List five (5) potential sources of error that must be evaluated
when performing a Risk Assessment for an IQCP. (5 points)

a. The Specimen
b. The Environment

c. The Reagents
d. The Test System
e. The Testing Personnel All good

15.
This COLA lab uses mass spectrometry to confirm drug levels
from urine samples. The cutoff values for all analytes are 25
ng/ml. The laboratory runs three levels of controls for every
analyte. The values of the controls are 25 ng/ml, 50 ng/ml and
100 ng/ml before and after each run. Is this laboratory running
successful QC for their mass spec testing? Why or why not? (3
points) Yes they are running appropriate QC for their mass spec
testing. To be compliant at least two controls must bracket the
cutoff value. This means they must be below or equal to the
cutoff value for the low value and at or above the cutoff for the
high value. Since the cutoff value is 25ng/ml, the low control of
25ng/ml and high controls of 50ng/ml and 100 ng/ml will be
sufficient. Good

16.
Please fill in the chart with a Y for Yes or an N for No
indicating if these positions need to be filled in Moderate or High
Complexity laboratories. (6 points) All correct
Complexity

Moderate
High

Lab
Director

Clinical
Consultant

Technical
Consultant

Y
Y

Y
Y

Y
N

Technical
Supervisor

N
Y

General
Supervisor

Testing
Personnel

N
Y

Y
Y

17.
A COLA laboratory performs 16 different urine drugs by
screening on the Mindray BS-200. The system reports out
positive or negative results which are based on a single point
calibration. Results at or above the calibrator are reported as
positive. Results below the calibrator are reported as negative. Is
this lab in compliance with COLA criteria? Does this lab need to
perform calibration verification for each analyte? (4 points)
Calibration verification is only required if the manufacturer
requires it. COLA does not require cal ver for qualitative methods
based on absorbance.
However, good lab practice would be to verify the cutoff point by
running calibrator material above and below the cutoff every 6
months. Good answers
18.
Concerning Competency Assessment, give one example of
how a laboratory can show competency for the following
elements (4 points):
a. Assessment of test performanceutilize PT results, blind
sampling results, or create a set of samples to test

b. Assessment of problem solving skillsReview problem logs,

incident reports and see if proper corrective actions were
performed. Also interview personnel about certain
situations (failed QC, ect) and how they would handle
them. Both good

19.
A lab has contacted COLA as they are now performing H
pylori testing by a breath analyzer method. The lab said that they
cannot find PT for their new method. What does the laboratory
need to do to meet all COLA and CLIA requirements? (3 points)
Breath testing is not CLIA regulated and thus is not included in
our survey or part of our accreditation process.
However, the lab can be educated that good lab practice for any
testing means you should at a minimum follow manufacturers
directions. Suggest that they contact the various PT agencies for
assistance on PT samples available for breath testing.
Good
20.
For each of the analytes listed below, state whether PT is
required, whether split samples will suffice, or that neither PT nor
split samples are required. If neither PT nor split samples are
required, give an example how the lab could monitor
performance. (7 points)
a. White Blood Cell Count --required
b. Direct Antiglobulin Testneither, however, should
perform some sort of internal comparison (two employees
perform testing, then review results). Good
c. Troponin-Iunregulated, either SS or PT is acceptable
Good
d. Phosphorusunregulated, either SS or PT is acceptable
Good

e. Semen Analysis (presence or absence)neither, however,

should perform some sort of internal comparison (two
employees perform testing, then review results) Good

21.
A lab is performing a waived strep screen using an antigen
detection methodology. The package insert states that external
QC (positive and negative) need to be performed when opening
each test kit. The package insert also states that the procedural
control needs to be recorded each day of patient testing.
Examining their records you find the procedural controls are
recorded daily, but there is no evidence of any external controls
being performed. How would you handle this situation? (2 points)
Educate and cite WAV2, WAV 4
Surveyor comments: There was no indication of any external controls being
performed as per the manufacturers recommendation (upon opening each test
kit).
Additionally, there was no indication of review of the QC results by the lab
director or designee. I did not mention this. And it was reviewed. So no WAV 4
citation.

22.
You are examining the personnel records in a moderate
complexity laboratory. The two new testing personnel are
Certified Medical Assistants. They have their Certificate of
Completion of the Medical Assistant Program from the local
Community College as well as their Certified Medical Assistant

cards. Are these documents sufficient to meet the minimum

education requirements for their position in the laboratory? Why
or why not? 4 points Not sufficient, an MA certificate is a
technical training program and not an educational document
accepted by CLIA (and us). Good. cite PER 3, require educational
documentation of either a GED, HSD, AA, BS, foreign equivalency
documentation, plus LDR 3, PER 4c. I didnt ask for this, but
good answer too.
23.
This COLA lab performs basic and comprehensive chemistry
panels on the Olympus AU 400. There are no records of
calibrations. When asked about calibration, the new lab person
stated that she could only find calibration verification which was
performed every six months on all Olympus analytes. The lab has
always passed their calibration verification and has not had any
QC or PT issues. Is this lab in compliance with COLA criteria? Why
or why not? What question(s) would be cited, if any? (4 points)
Not in compliance, calibration verification is not calibration: cite
CA 1, and applicable personnel--PER 4c, PER 4e, LDR 2. Good
24.
This COLA lab performs both waived and non-waived
testing. The lab is correctly enrolled in PT for all non-waived tests,
but is not enrolled in PT for any waived tests. Other than this
issue, there were no other citations for this lab. What citation(s)
would you cite if any? How would this issue affect the PRI or
post-survey process for this laboratory? (2 points) Cite WAV 10,

but inform the lab this is educational only and will not prevent
them from receiving an LEA if they meet all other criteria.
Until workflow issues are resolved, should contact
Kathy/headquarters to make certain this survey is reviewed for
possible LEA. Good. Not sure of your last sentence. Bring this
point up when this question is reviewed.
25.
What is the minimum regulatory requirement for Quality
Control for a non-waived direct antigen test for Chlamydia
trachomatis? (2 points). Positive and negative QC every day of
testing unless IQCP performed. Good
26.
What are the three (3) required elements for an
Individualized Quality Control Plan? (3 points)
Risk Assessment
QC Plan
QA Review as a component of your QA Plan
All good
27.
Describe the principle of operation of an LC/MS/MS analyzer
that performs urine drug confirmations. (4 points)
LC/MS is the combination of two techniques, liquid chromatography
and mass spectrometry that have the ability to separate different
compounds within a mixture. In our situation it is used most
predominantly for toxicology testing in urine samples. High Phase
Liquid Chromatography (HPLC) separates different compounds within
a mixture by stationary and mobile phase. The mobile phase travels
through the stationary phase which has compounds (silicone gel, for
example) to allow the compound to be separated into the different

particles being examined. This is determined by the speed at which

they travel through the column. The longer the mobile phase the
more clear-cut the separation of analytes are. Great explanation of
LC. Once separated, the ions (where did the ions come from? enter a
photodiode array to be analyzed (light into current) never heard of
this, then to the mass spec to be nebulized and sent through the
quadrupoles to determine their molecular mass. This is then
compared to known molecules and identified. (MS/MS means that
two mass specs are attached to the LC system to allow for more
identification to take place.) First MS filters, Q2 fragments, the
second MS filters for specific products. 1.6 points

28.
Describe the notification requirements of the following
JCAHO laboratories with regard to when they are going to have a
survey: (4 points)
a. An applicant JCAHO laboratory, test volume 45,000.
5 business days
b. A second cycle JCAHO laboratory with a test volume of
15,000 tests.
5 business days
c. A third cycle JCAHO laboratory with a test volume of 2550,000. unannounced
d. An applicant JCAHO laboratory with a test volume of 2,000.
5 business days
All correct