Study Guide
National Registry of Microbiologists
The National Registry of Microbiologists
© 2005 American Society for Microbiology
TABLE OF CONTENTS
Examination Content .............................................................................................................................................................................3
Consumer Products and Quality Assurance Microbiology–RM(NRM)
Task List.......................................................................................................................................................................................4
Sample Questions........................................................................................................................................................................6
Resources ..................................................................................................................................................................................11
Consumer and Industrial Microbiology–SM(NRM)
Task List.....................................................................................................................................................................................13
Sample Questions......................................................................................................................................................................15
Resources ..................................................................................................................................................................................19
Biological Safety Microbiology–SM(NRM)
Task List.....................................................................................................................................................................................21
Sample Questions......................................................................................................................................................................23
Resources ..................................................................................................................................................................................27
2
EXAMINATION FORMAT AND RESOURCES
Question Format and Content
The examination consists of 150 multiple-choice questions.
¾
¾
¾
¾
¾
¾
Each question has only one correct answer.
Questions have a stem and up to five possible responses.
Questions are updated and re-evaluated annually.
Questions are classified by domain and then by task.
The examination will have at least one question from each task. A task list for each specialty examination is included in the study guide.
The number of questions from each domain is listed next to the domain’s description on the task list for each examination.
Scoring
The NRM uses a criterion-referencing system for determining examination scores. This method sets a standard of performance in absolute, not
relative, terms. As a result, you are not graded on a curve and do not compete against other examinees. If you perform at or above the
established criterion standard, you pass the examination and are certified.
The number of correct answers determines your score. One point is given for each correct answer. There is no penalty for guessing; therefore, it is
in your best interest to answer all questions. Answer sheets are scored electronically.
About the Resource Lists
The resources listed at the end of each Task List are NOT meant to be comprehensive guides to the examinations. They are merely suggested
references for review. If you have questions about any of the material, please do not hesitate to contact the NRM office.
3
Consumer Products and Quality
Assurance (CP/QA) Task List
Specialty examinations consist of 100 general questions and 50
specialty questions.
General Tasks
I. LABORATORY INSTRUMENTS AND EQUIPMENT
(21 questions)
1. Validate, use, and monitor a steam autoclave.
2. Use a pH or conductivity meter.
3. Use various types of microscopes (e.g., light field, dark field,
phase contrast, fluorescence).
4. Use filtration equipment for sterilization of solutions.
5. Use spectrophotometric and colorimetric equipment.
6. Use fermentors and/or continuous culture apparatuses.
7. Use laminar flow hood and biosafety cabinets.
8. Use incubation chambers and appropriate controls.
II. LABORATORY PREPARATIONS (12 questions)
9. Use general stains (e.g., Gram, nigrosin, spore, Ziehl-Neelsen,
Kinyoun, flourescent).
10. Prepare and perform appropriate quality control checks on media
from commercial dehydrated materials and supplements.
11. Use general, selective, or differential media for bacteria.
12. Use general, selective, or differential media for fungi.
13. Prepare solutions of known molarity, molality, and normality.
14. Prepare and use buffers.
III. LABORATORY PROCEDURES (43 questions)
15. Isolate and identify Bacillus or other gram-positive, aerobic
bacilli.
16. Isolate and identify Pseudomonas and other oxidative, gramnegative bacilli.
17. Isolate and identify Enterobacteriaceae.
18. Isolate and identify Staphylococcus.
19. Isolate and identify Streptococcus.
20. Perform precipitation, agglutination, immunoassay, and
immunoflourescence tests.
21. Perform broth or agar susceptibility tests of antimicrobials.
22. Detect and measure the growth of microorganisms (e.g., by
substrate utilization, turbidity, impedance, and rapid
methodologies).
23. Determine inactivation rates of microorganisms by chemical and
physical means.
24. Use viable plate count procedures.
25. Use most-probable-number technique.
26. Perform tests for water suitability in production systems.
27. Perform phenol coefficient tests or similar tests on disinfectants.
28. Use and maintain cell cultures.
29. Apply appropriate statistical and analytical techniques to test
results.
30. Perform standard biochemical tests for organism identification.
31. Use specialized techniques for identification of bacteria and
yeasts (e.g., fatty acids, electrophoresis, DNA probes, enzymelinked immunosorbent assay [ELISA], commercial kits).
32. Understand the advantages and limitations of various
sterilization procedures.
IV. LABORATORY OPERATIONS (24 questions)
33. Use appropriate safety techniques for the isolation and transfer
of biological materials (e.g., loops, pipets, dilutor tips).
34. Handle, store, transport, and dispose of etiologic agents or
biologics in compliance with laboratory and government
regulations.
35. Handle, store, and dispose of hazardous chemicals and
radiologic agents in compliance with laboratory and government
regulations.
36. Document and maintain laboratory records and procedures.
37. Monitor the environment during process operations.
38. Maintain stock cultures.
39. Perform studies to determine sources of contamination.
40. Operate within environmentally controlled rooms, including clean
rooms.
41. Evaluate clean-in-place and sterilize-in-place systems (e.g.,
validation procedures, monitoring procedures, troubleshooting).
VII. STERILIZATION AND DEPYROGENATION
VALIDATION (10 questions)
CP/QA Pharmaceutical/Medical Device/Cosmetic
Specialty Tasks
VIII. SAMPLE COLLECTION AND HANDLING
(12 questions)
V. SAMPLE COLLECTION AND HANDLING
(13 questions)
59. Prepare samples for microbiological analysis (e.g., sample size,
blending, dilutions, incubation conditions).
60. Collect and evaluate samples for environmental and quality
control/quality assurance testing.
61. Select appropriate methods for transport, handling, and storage
of samples.
42. Prepare samples for microbiological analysis (e.g., sample size,
blending, dilutions).
43. Collect and evaluate industrial samples for quality assurance and
quality control testing.
44. Select appropriate methods for transport, handling, and storage
of samples.
VI. LABORATORY PROCEDURES (27 questions)
45.
46.
47.
48.
49.
50.
51.
52.
53.
Isolate and identify yeasts of importance in industry.
Perform and validate tests for sterility.
Perform bacteriostatic or fungistatic tests.
Perform tests for particulate matter.
Perform and validate tests for pyrogens.
Perform and validate bioburden tests.
Perform tests for the effectiveness of preservatives.
Perform mutagen and cytotoxicity assays.
Perform process equipment and/or product validation studies.
54.
55.
56.
57.
58.
Ethylene oxide sterilization.
Radiation sterilization.
Chemical and plasma sterilization.
Sterilization by filtration.
Depyrogenation.
CP/QA Food and Dairy Specialty Tasks
IX. LABORATORY PROCEDURES (38 questions)
62. Isolate and identify Listeria.
63. Isolate and identify Enterobacteriaceae (e.g., Salmonella,
Proteus, Citrobacter, pathogenic Escherichia coli).
64. Isolate and identify Vibrio and Campylobacter.
65. Isolate and identify Clostridium species.
66. Isolate and identify microorganisms in food and dairy products.
67. Isolate, identify, and handle cultures of importance in food and
dairy production (e.g., commercial starters).
68. Perform tests for spoilage and sterility in canned foods.
69. Perform shelf life studies.
70. Perform microbiological growth factor assays.
71. Perform tests for and identify extraneous materials in foods.
72. Use irradiation, biocontrol agents, preservatives, and other
processing methods to control pathogens and spoilage bacteria
in foods.
73. Perform aseptic process and/or product validation studies.
74. Perform direct microscopic counts.
5
CP/QA Sample Questions
General CP/QA questions (for both Pharmaceutical/
Medical Device/Cosmetic and Food and Dairy
examinations)
1. Phase-contrast microscopy enables the human eye to observe
structures not visible by bright field-microscopy by modifying the
light:
a. path by 90°.
b. contrast.
c. intensity.
d. wavelength.
e. amplitude.
Corresponds to task #3.
2. To achieve Kohler illumination, the height adjustment of the
condenser should be:
a. at its upper stop.
b. at its lower stop.
c. halfway between its upper and lower stops.
d. lowered slightly from its upper stop.
Corresponds to task #3.
3. What is the greatest drawback in the use of UV-visible
spectrophotometry in quantitative analysis?
a. Inadequate linearity
b. Inadequate sensitivity
c. Inadequate specificity
d. Excessive noise levels
e. Problems in choosing appropriate blanks
Corresponds to task #5.
6
4. Before a laminar flow hood is used, it should be running a
minimum of:
a. 2 hours.
b. 24 hours.
c. 15 to 30 minutes.
d. 5 to 10 minutes.
e. 1 week.
Corresponds to task #7.
5. Which quality control procedure is necessary to perform with
every batch of media?
a. Shelf life determination
b. Endotoxin content
c. Buffering capacity
d. Bacteriostatic/fungistatic tests
e. Sterility check
Corresponds to task #10.
6. Pyrogallic acid with sodium hydroxide would be added for which
of the following functions?
a. Provide for anaerobic conditions
b. Provide essential nutrients to the organisms
c. Alter the pH of the medium
d. Chelate metallic elements in the medium
e. Bacteriocidal action
Corresponds to task #13.
7. When isolating motile, oxidative, nonfermenting gram-negative
rods, which of the following should one look for in order to
separate them from Pseudomonas species?
a. An oxidative reaction on O/F glucose
b. Polar pili
c. The fermentation of dextrose
d. Peritrichous versus polar flagella
e. A negative indophenol oxidase reaction
Corresponds to task #16.
8. A gram-negative organism was isolated with the following
characteristics: oxidase-positive, motility-positive, growth at 42°C
and production of pyocyanin. The organism isolated is:
a. Escherichia coli.
b. Pseudomonas cepacia.
c. Pseudomonas aeruginosa.
d. Staphylococcus aureus.
e. Pseudomonas stutzeri.
Corresponds to task # 16.
9. For the formation of immunoprecipitates, the almost universal
optimal agar gel (Ouctherlony) concentration is:
a. 0.03 to 0.15%.
b. 0.15 to 0.3%.
c. 0.3 to 1.5%.
d. 1.5 to 3.0%.
e. 3.0 to 5.0%.
Corresponds to task #20.
10. Precipitation tests for the detection of antigens are often carried
out using:
a. the agar diffusion method.
b. high-performance liquid chromatography (HPLC).
c. the complement fixation method.
d. passive agglutination.
e. polyacrylamide gel electrophoresis (PAGE).
Corresponds to task #20.
11. Fluorescence detected in immunofluorescent technique is
photons emitted from the:
12. A microscope outfitted with excitation, suppression, and heat
filters is necessary to detect:
a. peritrichous flagella.
b. immunofluorescence.
c. capsules.
d. beta-hemolysis.
e. fat soluble granules.
Corresponds to task #20.
13. Cross-reactivity in serologic reactions may lead to false-positive
reactions and can be expected when:
a. antigens are not in optimal proportions to the antibodies.
b. there is no electrolyte in the system.
c. several antigens are closely related.
d. complement has not been inactivated.
e. the dilutent is hypotonic.
Corresponds to task #20.
14. The scientific literature contains a number of references showing
that antibiotic potency tests carried out with saturated paper
disks are equivalent to the United States Pharmacopeia (USP)
cylinder plate method. A laboratory wanting to change from
cylinders to paper disks should:
a. proceed to do so without further ado.
b. provide definite proof of equivalence of the two tests for each
antibiotic from the literature.
c. provide proof of equivalence for each family of antibiotics for
each medium used.
d. provide some proof of equivalence for each test organism.
e. provide some proof of equivalence for each antibiotic.
Corresponds to task #21.
a. antigen.
b. antibody.
c. antiglobulin antibody.
d. antigen-antibody complex.
e. fluorescent dye.
Corresponds to task #20.
7
15. The agar diffusion test is the most convenient for antimicrobic
susceptibility testing. However, antimicrobial dilution tests may
be required if:
a.
b.
c.
d.
simple qualitative information is needed.
isolates are capable of growing at a uniform rapid rate.
the drug has no diffusion problems.
a fairly large number of drugs need to be screened at the
same time.
e. quantitative information is needed.
Corresponds to task #21.
16. The time at a given temperature required to destroy 90% of the
organisms is called the:
a. thermal death time.
b. thermal death point.
c. D value.
d. F value.
e. Z value.
Corresponds to task #23.
17. A 24-hour culture of Bacillus subtilis contains 2.4 × 106 CFU/ml.
Sequential dilutions of 1:10, 1:5, 1:100, and 1:3 were made from
the original samples. The final titer is:
a. 4.8 × 103 CFU/ml.
b. 1.6 × 103 CFU/ml.
c. 8.0 × 102 CFU/ml.
d. 4.8 × 102 CFU/ml.
e. 1.6 × 102 CFU/ml.
Corresponds to task #24.
18. The process of disinfection refers to:
a. the destruction of disease-producing organisms.
b. sterilization.
c. the removal of all bacteria.
d. the killing of all vegetative bacteria.
e. the destruction of all bacterial spores.
Corresponds to task #27.
8
19. What standard is used for comparing the effectiveness of certain
disinfectants?
a. Iodine index
b. Phenol coefficient
c. Alcohol index
d. Hexachlorophene coefficient
e. Creosol index
Corresponds to task #27.
20. In order to identify a gram-negative, aerobic, nonfermenting,
oxidase-negative bacterium, one should use a commercial kit
which differentiates:
a. genus Propionibacterium from Fusobacterium.
b. genus Pseudomonas from Acinetobacter.
c. genus Fusobacterium from Actinomyces.
d. genus Fusobacterium from Bacteroides.
e. various Enterobacteriaceae.
Corresponds to task #31.
21. Which of the following should be added to a commercial
identification kit in order to create anaerobic conditions?
a. Nitrogen gas
b. Water
c. Mineral oil
d. Plastic wrap
e. Sterile cotton plugs
Corresponds to task #31.
22. A laboratory's liability for its hazardous waste ends:
a. when the hazardous waste is legally removed from the
premises.
b. when the hazardous waste is diluted and poured down the
drain.
c. when the waste has been mixed with hazardous wastes from
another source by another party.
d. when the waste no longer exists or is recycled.
Corresponds to task #35.
23. The Resources Conversion and Recovery Act (RCRA) for
hazardous waste requires:
a. 60% of all medical waste to be recycled.
b. medical waste to be disposed of within the state generated.
c. a separate loading dock for hazardous waste.
d. a cradle-to-grave tracking system.
e. licensing requirements for class IV pathogens.
Corresponds to task #35.
Pharmaceutical/Medical Device/Cosmetics Specialty
Questions
24. Which of the environmental conditions listed below would be
selective of a mesophilic, anaerobic heterotroph?
Temperature
Source
pH
Atmosphere
7.0
N2
a. 10oC
b. 60oC
3.0
air
c. 60oC
1.0
air
d. 10oC
7.0
air
e. 30oC
7.0
N2
Corresponds to tasks #42 and 59.
Energy
glucose
sulfur
glucose
glucose
glucose
25. According to Standard Methods for the Examination of Water
and Wastewater, what is the maximum allowable time at 4°C for
potable water samples that are to be plated?
a. 6 hours
b. 24 hours
c. 30 hours
d. 36 hours
e. 48 hours
Corresponds to task #43.
26. The following units were sent to the laboratory for testing:
100 sterile samples for sterility tests
10 non-sterile samples for bioburden tests
10 non-sterile samples for pyrogen tests (in vitro)
3 extra sterile samples
The units were packaged and shipped in a cardboard box. When
the packages were opened with a razor box opener, two of the
nonsterile packages were found to be damaged. How can the
problem BEST be solved?
a. Proceed by using the two damaged units for the bioburden
test and note the damage on the report.
b. Use two sterile units for the bioburden test.
c. Use two sterile units for the pyrogen test.
d. Perform the pyrogen test on eight units only, as sterility data
will provide adequate information on pyrogen safety.
e. Use two of the units for both the in vitro pyrogen test and the
bioburden test.
Corresponds to task #43.
27. The growth of all bacteria requires that bacteriological liquid
media provide an energy source plus:
a.
b.
c.
d.
KH2PO4, MgSO4, (NH4)2SO4, and trace elements.
vitamins, a buffer, trace elements, and sulfur.
a buffer, O2, vitamins, and a nitrogen source.
hydrolytic products of proteins, vitamins and other growth
factors, a buffer and trace elements.
e. appropriate sources of C, H, N, P, and S, as well as trace
elements.
Corresponds to task #43.
9
28. One of the problems with the USP sterility test is that the test
cannot be used to detect contamination in:
a. ointments and oils.
b. large numbers of contaminated containers from a lot of
10,000.
c. small numbers of contaminated containers from a lot of
10,000.
d. parenteral antibiotic solutions.
e. monoclonal antibodies.
Corresponds to task #46.
29. What is the minimum detectable range of manual particle counts
at 100×, according to the USP?
a. 5 µm
b. 10 µm
c. 25 µm
d. 50 µm
e. 100 µm
Corresponds to task #48.
30. Which indicates the MOST toxic cellular response in an in vitro
cytotoxicity assay?
a. Nonconfluent cell monolayer
b. Granulation
c. Crenation
d. Acidic shift in pH of growth medium
Corresponds to task #52.
31. The two most common gases used for plasma sterilization are:
a. hydrogen peroxide and peracetic acid.
b. argon and hydrogen.
c. hydrogen peroxide and ethylene oxide.
d. hydrogen peroxide and acetic acid.
Corresponds to task #56.
10
Food and Dairy Specialty Questions
32. The food-poisoning toxins produced by Staphylococcus aureus
are:
a. exotoxins.
b. lethal poisons.
c. endotoxins.
d. heat labile.
e. composed of carbohydrates.
Corresponds to task #66.
33. Saccharomyces cerevisiae var. ellipsoideus may be
differentiated from Saccharomyces cerevisiae by:
a. pH requirement.
b. sugar fermentation.
c. morphology.
d. ascospore formation.
e. amino acid requirements.
Corresponds to task #67.
34. Which of the following is a direct microscopic count technique?
a. Smear
b. Microcytic count
c. Macrocytic count
d. Spiral count
e. Acid wash
Corresponds to task #73.
ANSWERS
1.
2.
3.
4.
5.
a
d
c
c
e
6.
7.
8.
9.
10.
a
d
c
c
a
11.
12.
13.
14.
15.
e
b
c
e
a
16.
17.
18.
19.
20.
c
e
a
b
b
21.
22.
23.
24.
25.
c
d
d
e
c
26.
27.
28.
29.
30.
c
e
c
b
a
31.
32.
33.
34.
a
a
c
a
RESOURCES
General Tasks
Cunniff, P.A., et al. (ed.). Official methods of analyis. AOAC
International, Gaithersburg, Md.
Standard methods for the examination of water and wastewater.
American Public Health Association (APHA), Washington, D.C.
Biosafety in microbiological and biomedical laboratories. U.S.
Department of Health and Human Services, Centers for Disease
Control and Prevention, and National Institutes of Health. U.S.
Government Printing Office, Washington, D.C.
U.S. Food and Drug Administration. Current good manufacturing
practice in manufacturing, processing, packing, or holding of drugs;
general. Title 21, Code of Federal Regulations, section 210 (21 CFR
210). U.S. Government Printing Office, Washington, D.C.
www.gpoaccess.gov/cfr/index/htm.
Pharmaceutical/Medical Device/Cosmetic
Tasks
Critical References
United States Pharmacopeia and National Formulary. The
United States Pharmacopeial Convention, Inc. Rockville, Md.
Selected titles from the Association for Advancement of Medical
Instrumentation (AAMI).
Selected titles from Parenteral Drug Association Technical
Monographs.
Helpful References
Journals
PDA Journal of Pharmaceutical Science and Technology.
Medical Device & Diagnostic Industry.
The Microbiological Update.
Food and Dairy Tasks
Critical References
Standard methods for the examination of dairy products.
American Public Health Association, Washington, D.C.
U.S. Food and Drug Administration (FDA). 1995. Bacteriological
analytical manual (BAM), 8th ed. AOAC International, Arlington, Va.
Updates available at http://vm.cfsan.fda.gov/~ebam/bam-toc.html.
Vanderzant, C., and D.F. Splittstoesser (ed.). Compendium of
methods for the microbiological examination of foods. American
Public Health Association, Washington, D.C.
11
Helpful References
Dey, B.P., and C.P. Lattuda (ed.). 1998. Microbiology laboratory
handbook, 3rd ed. United States Department of Agriculture, Food
Safety and Inspection Service. U.S. Department of Agriculture,
Washington, D.C.
Journals
Food Technology.
Food Testing and Analysis.
Journal of Food Protection.
Journal of Validation Technology.
The Microbiological Update.
Internet
USP.
AAMI.
AOAC.
APHA.
FDA.
12
http://www.usp.org.
http://www.cssinfo.com/info/aami.html.
http://www.aoac.org.
http://www.apha.org.
http://www.fda.gov.
Consumer and Industrial
Microbiology
(C & I) Task List
General Tasks
I. LABORATORY INSTRUMENTS AND EQUIPMENT
(19 questions)
1. Use and monitor sterilization equipment (e.g., autoclaves, ovens,
ethylene oxide, radiation).
2. Use and monitor filters for sterilization of solutions.
3. Use and monitor incubation devices such as ambient air, carbon
dioxide, anaerobic, and constant water temperature devices.
4. Use a pH meter or conductivity meter.
5. Use locally controlled environmental systems (e.g., biosafety
cabinets, unidirectional [laminar] flow cabinets, isolators).
6. Use various types of microscopes.
7. Use colorimetric and spectrophotometric equipment.
8. Use of electronic monitoring of equipment (chart recorders,
multipoint recorders) and understand electronic data trending
(storage, retrieval, auditing, electronic signature; Code of Federal
Regulations, title 21, section 11 [21 CFR 11]).
9. Calibrate and maintain laboratory equipment.
II. LABORATORY PREPARATIONS (9 questions)
10. Evaluate media (general, selective, and differential) for growth,
isolation, and identification of bacteria and fungi.
11. Perform medium growth promotion tests.
12. Use stains, both general and for specific structures (spores,
flagella, capsules).
13. Prepare solutions of known molarity, molality, and normality.
III. SAMPLE COLLECTION AND HANDLING (2
questions)
14. Select appropriate means of disposal for analyzed or unanalyzed
samples.
15. Use appropriate documentation procedures for samples involved
in legal actions (e.g., chain-of-custody documentation).
IV. LABORATORY PROCEDURES (28 questions)
16. Understand and apply biochemical tests for bacterial
identification (e.g., carbohydrate fermentations, redox reactions,
catalase, coagulase, oxidase).
17. Isolate and identify coliforms.
18. Isolate and identify Pseudomonas species and common
waterborne organisms.
19. Isolate and identify common fungi (e.g., Aspergillus species,
yeast).
20. Perform analytical procedures for the evaluation of water and
potable water.
21. Perform measurements for the growth of microorganisms (e.g.,
substrate utilization, plate counts, turbidity).
22. Use most-probable-number technique.
23. Perform microbial tests on disinfectants.
24. Perform identification of bacteria using biochemical, genetic, or
chromatographic procedures (e.g., DNA probes, polymerase
chain reaction [PCR], sequencing, fatty acid methyl esters,
carbohydrate utilization).
25. Understand rapid microbiological techniques (e.g.,
bioluminescence, impedence, cytometry).
26. Use or detect viruses and/or mycoplasma.
27. Evaluate new test procedures or procedures that are alternative
to compendial procedures.
13
V. LABORATORY OPERATIONS (26 questions)
Pharmaceutical/Device/Cosmetic Specialty Tasks
28. Monitor proper handling of hazardous chemicals, radioactive
materials, and biological agents.
29. Establish and maintain standard operating procedures (SOPs)
(e.g., methods, procedures, equipment maintenance, calibration,
repair, replacement).
30. Develop and maintain effective laboratory quality systems (e.g.,
documentation, controls, trend analysis of laboratory data,
proficiency testing).
31. Supervise maintenance and inventories of stock cultures and
preserve biological specimens.
32. Develop and maintain laboratory safety practices.
33. Apply appropriate statistical and analytical techniques to test
results.
34. Make recommendations for action based on analytical results,
including failure investigation.
35. Document and maintain an ongoing training program.
36. Understand use of risk analysis for determining objectionable
microorganisms and actions to take.
VII. SAMPLE COLLECTION AND HANDLING
(7 questions)
VI. MANUFACTURING EQUIPMENT, FACILITIES,
AND PROCESSES (15 questions)
50.
51.
37. Establish and maintain environmental monitoring procedures
(e.g., of personnel; in laboratory, production areas,
warehouses).
38. Evaluate clean-in-place and sterilize-in-place systems (e.g.,
validation procedures, monitoring procedures, troubleshooting).
39. Determine lethal rates of microorganisms (e.g., sterility
assurance level, D value, F0 value).
40. Perform and/or evaluate audits of contract manufacturers and
laboratories.
41. Understand and apply good laboratory practices according to
existing regulations (e.g., U.S. Food and Drug Administration
[FDA], Good Laboratory Practices [21 CFR 58], AOAC ISO
17025 [Accreditation Criteria for Laboratories Performing Food
Microbiological and Chemical Analysis in Foods, Feeds, and
Pharmaceutical Testing]).
14
42. Select appropriate methods for sample storage and transport.
43. Prepare samples for microbiological analyses (e.g., proper
mixing, dilutions, dispersing, neutralization of microbial
inhibitors).
44. Select appropriate sample plans, collection materials, and
collection equipment.
VIII. LABORATORY PROCEDURES (22 questions)
45.
46.
47.
48.
49.
52.
53.
54.
Isolate and identify gram-positive organisms.
Isolate and identify gram-negative organisms.
Perform and validate tests for sterility.
Perform and evaluate tests for bioburden.
Perform tests for bacterial endotoxins (Limulus amebocyte lysate
[LAL]).
Perform and validate tests for the effectiveness of preservatives.
Perform biocompatibility tests (e.g., cytotoxicity, mutagenicity
[Ames]).
Use and maintain cell culture lines for production.
Perform immunoassays (e.g., enzyme-linked immunosorbent
assay [ELISA], precipitation, agglutination,
immunofluorescence).
Evaluate container/closure systems.
IX. MANUFACTURING EQUIPMENT, FACILITIES,
AND PROCESSES (17 questions)
55. Use centrifuges and/or ultracentrifuges.
56. Validate filtration equipment.
57. Use continuous culture apparatus and monitor fermentation
processes.
58. Evaluate and validate manufacturing processes, fill lines, and
packaging.
59. Monitor gowning techniques for manufacturing processes.
60. Validate and monitor clean rooms and controlled environments.
61. Monitor and evaluate gases used in manufacturing processes.
62. Validate and monitor water purification systems (e.g., deionized
water, purified water, water for injection, biofilm control).
63. Validate sterilization and depyrogenation processes (e.g., steam,
dry heat, gas, radiation).
X. REGULATIONS (5 questions)
64. Demonstrate knowledge of Good Manufacturing Practices (21
CFR 210, 211, and 600).
65. Demonstrate knowledge of compendial and standard methods
for microbiological analysis (e.g., AOAC, United States
Pharmacopeia and National Formula [USP-NF], and FDA
Bacteriological Analytical Manual [FDA-BAM]).
C&I Sample Questions
General Tasks
1. The most reliable way to monitor the adequacy of the sterilization
cycle of an autoclave is to:
a. use endospore strips.
b. use tape indicators.
c. allow 15 minutes at 15 pounds of pressure.
d. allow 15 minutes at 121°C.
e. use methylene blue strips.
Corresponds to task #1.
2. If you were preparing a sterile, heat-labile pharmaceutical
solution, which one of the following pore sizes would you select
for membrane filtration of the solution?
a. 0.1 µm
b. 0.2 µm
c. 0.5 µm
d. 1.0 µm
Corresponds to task #2.
3. In-line filter integrity tests should be performed:
a. at the beginning of the filtration process.
b. at the middle and end of the filtration process.
c. at the middle of the filtration process.
d. at the beginning and end of the filtration process.
e. when the bulk bioburden exceeds established limits.
Corresponds to task #2.
15
4. Which device would give the most rapid and consistent
temperature equilibration within a culture?
a. Gravity incubator
b. Anaerobic incubator
c. Convection incubator
d. Circulating water bath
e. Low-temperature incubator
Corresponds to task #3.
5. A pH meter should have a compensation adjustment control for:
a. light.
b. color.
c. magnetism.
d. altitude.
e. temperature.
Corresponds to task #4.
6. Your pH meter seems to drift excessively after calibration. What
is the most likely cause?
a. Improper temperature
b. Voltage surges
c. Slope drift
d. A faulty LED
e. Contaminated electrodes
Corresponds to task #4.
7. High-efficiency particulate air (HEPA) filters in laminar flow
cabinets must remove what percentage of 0.3-µm particles to be
acceptable?
a. 90.00
b. 95.00
c. 99.95
d. 99.97
Corresponds to task #5.
16
8. The purpose of bile salts, citrate, brilliant green, and
desoxycholate is to:
a. make the media differential.
b. enhance the growth of enteric pathogens.
c. make the media selective.
d. buffer the pH of the media.
Corresponds to task #10.
9. Microorganisms which produce a clear zone around colonies on
a skim milk agar plate after the plate is flooded with hydrochloric
acid may be classified as:
a. lipolytic.
b. peptolytic.
c. proteolytic.
d. saccharolytic.
Corresponds to task #10.
10. The poured plates of Baird Parker staphylococcus agar have
clear lumps in them. What is the most likely explanation for the
clear lumps?
a. The egg yolk tellurite supplement was added when the agar
was too hot.
b. The egg yolk tellurite was added after the agar base was too
cool.
c. The agar base was not melted before autoclaving
d. The pH of the agar base was out of specification.
Corresponds to task #10.
11. An accurate written record that can be used to trace the
possession of a sample from the moment of its collection to the
completion of the analysis is known as the:
a. field data sheet.
b. final report.
c. chain of custody.
d. request for analysis.
Corresponds to task #15.
12. Coliforms are:
a. strict anaerobes.
b. hydrogen sulfide producers.
c. lactose fermenters.
d. gram positive.
e. sucrose nonfermenters.
Corresponds to task #17.
13. A potable water sample for routine microbiological analysis
arrives in your lab 48 hours after collection. You should:
a.
b.
c.
d.
reject the sample and ask for another sample.
analyze the sample.
analyze the sample but report the results as suspect.
analyze the sample but adjust the results based on the time
factor.
Corresponds to task #20.
14. Water samples for microbiological evaluation that are to be
shipped via overnight carrier must be packed:
a. with a cold pack to keep temperatures low.
b. in styrofoam or padding to prevent breakage.
c. in plastic to avoid breakage.
d. in insulated coolers to maintain temperature equilibrium.
Corresponds to task #20.
15. The microbial density of a suspension of a pure culture can be
determined by spectrophotometry with preparation of a:
16. Certain metabolites such as pyruvic, lactic, and fumaric acids are
methylated prior to gas chromatography in order to:
a. decrease retention time.
b. decrease volatility.
c. increase molecular weight.
d. decrease molecular weight.
e. increase retention time.
Corresponds to task #24.
17. Which reagent could be used for the dissociation of monolayers
in tissue subculturing?
a. DNase
b. DMSO
c. EDTA
d. Tween 80
Corresponds to task #25.
18. Bacterial cultures can best be recovered from storage in liquid
nitrogen if:
a. the cell suspension is prepared from an early-stationaryphase culture.
b. thawed at 37°C in a water bath.
c. they were originally suspended in a mixture of skim milk and
sucrose.
d. they were frozen rapidly in a dry ice/ethyl Cellusolve bath.
Corresponds to task #31.
19. The main purpose of a laboratory coat is to:
a. standard curve using pour plates.
b. MacFarland standard.
c. most-probable-number test.
d. dry-weight comparison.
e. protein/cytoplasm optical density regression.
Corresponds to task #21.
a. keep your clothes from being ruined.
b. help assess the cleanliness of the laboratory.
c. identify you as a trained professional.
d. keep contamination off your clothing.
e. give you access to several pockets at once.
Corresponds to task #32.
17
20. If a spill should occur within a biological safety cabinet (BSC),
what steps would immediately be taken?
a. Turn off the BSC and immediately wipe up the spill with a
dry, absorbent towel.
b. Turn off the BSC and wipe up the spill with a germicidal
agent.
c. Turn off the BSC, evacuate the laboratory, and notify
company safety authorities.
d. Leave the BSC on and wipe up the spill with a germicidal
agent.
e. Leave the BSC on and wipe up the spill with a dry,
absorbent towel.
Corresponds to task #32.
21. RODAC plates are used for:
a. air sampling.
b. surface sampling.
c. isolation of microbial colonies.
d. water sampling.
e. the phenol coefficient test.
Corresponds to task #37.
22. The D value stands for:
a. disinfectant efficacy rating.
b. time for a 90% population reduction.
c. diffusion rate through a 0.22-µm membrane filter.
d. temperature change required to destroy 1012 spores.
e. differential pressure.
Corresponds to task #39.
Pharmaceutical/Medical Device/Cosmetic Specialty
Tasks
23. Which of the following describes the family Enterobacteriaceae?
a. Oxidase-positive fermenters
b. Gram-positive, asporogenous, rod-shaped bacteria
c. Ferment glucose with formation of acid with or without gas
d. Gram-negative nonfermenters
e. Motile with polar flagella
Corresponds to task #46.
24. Glassware can be rendered pyrogen free by:
a. washing with a membrane-filtered 70% alcohol solution.
b. heating to 200°C for not less than 1 hour.
c. heating to 250°C for not less than 30 minutes.
d. heating to 100°C for not less than 15 minutes.
Corresponds to task #49.
25. Bentonite, blood cells, and latex beads are components used to:
a. enhance phagocytosis.
b. select xenotrophic organisms.
c. perform agglutination tests.
d. prepare selective media.
e. prepare live vaccines.
Corresponds to task #53.
26. Membrane filtration is based on the exclusion of bacteria at the
surface of the membrane and:
a. requires a pressure drop across the membrane.
b. relies on membrane depth and tortuosity of the pores.
c. the filter is constructed of materials which cannot be
sterilized.
d. requires a mean pore diameter greater than 0.5 µm.
e. is generally used with a filter aid such as diatomaceous
earth.
Corresponds to task #56.
18
27. A rapidly growing aerobic culture requires a fermentor which has:
a. large impellers.
b. a powerful motor.
c. high oxygen transfer.
d. baffles.
Corresponds to task #57.
ANSWERS
1.
2.
3.
4.
5.
a
b
d
d
e
6.
7.
8.
9.
10.
e
d
c
c
b
11.
12.
13.
14.
15.
c
c
a
a
a
16.
17.
18.
19.
20.
a
c
b
d
d
21.
22.
23.
24.
25.
b
b
c
c
c
26.
27.
28.
29.
30.
a
c
d
d
d
28. The deionized water system in your laboratory indicated low
resistivity. The MOST likely cause is:
a. a fouled ultrafiltration cartridge.
b. an incorrect bypass valve pressure.
c. a high particulate level in the feedwater.
d. the ion-exchange cartridges are exhausted.
e. the activated carbon cartridge requires a recharge.
Corresponds to task #62.
29. According to current Good Manufacturing Practices, deviations
from established hold time limits may be acceptable, provided
that:
a. the bulk of the bioburden does not exceed established limits.
b. the bioburden of the bulk solution does not exceed 107 CFU
per cm2 of the effective filter area.
c. the established holding time has been properly validated.
d. the deviation does not compromise the quality of the product
and is documented and justified.
e. Quality Assurance and Manufacturing has been notified and
approves of the deviation.
Corresponds to task #64.
30. Staff organization, methods validation, and handling of
documentation in a pharmaceutical manufacturing microbiology
quality control laboratory are regulated by:
a. the FDA 483 findings.
b. Good Laboratory Practices.
c. the Establishment Inspection Report.
d. current Good Manufacturing Practices.
e. ISO 9000.
Corresponds to task #64.
RESOURCES
General Tasks
Clesceri, L. S., A. E. Greenberg, and A. D. Eaton (ed.). Part 9000,
Microbiological examination: 9010-9060, 9212, 9215, 9221-9222,
9260. In Standard methods for the examination of water and
wastewater, 20th ed. American Public Health Association (APHA),
American Water Works Association, and Water Environment
Federation, Washington, D.C.
Cunniff, P. A., et al. (ed.). 2000. Microbiological methods. In Official
methods of analysis, 17th ed. AOAC International, Gaithersburg, Md.
Difco Manual. Difco Laboratories, Inc., and Becton Dickinson and
Co., Sparks, Md.
Environmental Protection Agency (EPA). 2001. Summary of
requirements. In Managing your hazardous waste: a guide for small
businesses. EPA530-K-01-005. Environmental Protection Agency,
Washington, D.C.
Laboratory safety: principles and practices. Chapters 1, 2, 19,
and 22. ASM Press, Washington, D.C.
Murray, P. R., E. J. Baron, M. A. Pfaller, F. C. Tenover, and R. H.
Yolken (ed.). 1999. Chapters: Microscopy, Quality control of media,
and Culture media. In Manual of clinical microbiology, 7th ed. ASM
Press, Washington, D.C.
19
U.S. Food and Drug Administration. Good laboratory practice for
nonclinical laboratory studies. Title 21, Code of Federal Regulations,
section 58 (21 CFR 58). U.S. Government Printing Office,
Washington, D.C. www.gpoaccess.gov/cfr/index/htm.
United States Pharmacopeial Convention. Chapters 51, 61, 71,
85, 1035, 1111, 1116, 1208, 1211, 1227, and 1231. In United States
Pharmacopeia and National Formulary. United States
Pharmacopeial Convention, Rockville, Md.
U.S. Food and Drug Administration. Guidance for industry;
electronic records; electronic signatures. 21 CFR 11. U.S.
Government Printing Office, Washington, D.C.
U.S. Food and Drug Administration. Current good manufacturing
practice for finished pharmaceuticals. 21 CFR 211. U.S. Government
Printing Office, Washington, D.C.
Pharmaceutical/Medical Device/Cosmetic Tasks
U.S. Food and Drug Administration. Quality system regulation. 21
CFR 820. U.S. Government Printing Office, Washington, D.C.
AOAC International. 2001. Accreditation criteria for laboratories
performing microbiological and chemical analyses in food, feeds, and
pharmaceutical testing. AOAC International, Gaithersburg, Md.
Association for Advancement of Medical Instrumentation
(AAMI). Selected titles, especially on sterilization. Association for
Advancement of Medical Instrumentation, Arlington, Va.
Association for Advancement of Medical Instrumentation. 2000.
Sterilization of health care products; requirements for validation and
routine control; industrial moist heat sterilization. ANSI/AAMI/ISO
11134:1993. Association for Advancement of Medical
Instrumentation, Arlington, Va.
Cosmetic, Toiletry, and Fragrance Association (CTFA). CTFA
microbiology guidelines. Cosmetic, Toiletry, and Fragrance
Association, Washington, D.C.
Olsen, W. P., and M. J. Groves (ed.). 1987. CIP/SIP system
validation. In Aseptic pharmaceutical manufacturing. Interpharm
Press, Prairie View, Ill.
Parenteral Drug Association. 1978. Validation of steam sterilization
cycles. Technical report 1. Parenteral Drug Association, Bethesda,
Md.
Pearson, F. 1985. Pyrogens, endotoxins, LAL testing, and
depyrogenation. Marcel Dekker, New York, N.Y.
20
U.S. Food and Drug Administration. 1995. Microbiological
methods for cosmetics. In Bacteriological analytical manual (BAM),
8th ed. AOAC International, Arlington, Va.
Internet
USP.
AAMI.
AOAC.
APHA.
CFR.
FDA-BAM.
http://www.usp.org.
http://www.cssinfo.com/info/aami.html.
http://www.aoac.orgd.
http://www.apha.org.
http://www.access.gpo.gov/nara/cfr.
http://www.cfsan.fda.gov/~ebam/bam-toc.html.
Biological Safety Task List
I. DISINFECTION, DECONTAMINATION,
STERILIZATION (7 questions)
1. Understand the difference between sterilization,
decontamination, and disinfection and the applicability and
means of monitoring each.
2. Demonstrate knowledge of use, applicability, and potential
hazards (explosive, flammable, corrosive, carcinogenic, and
irritating) associated with various disinfectants and sterilants.
3. Understand how to use chemicals, steam, dry heat, irradiation,
filtration, ultraviolet (UV) sources, gases, or other agents to kill or
inactivate microorganisms.
II. WORK PRACTICES AND PROCEDURES
(25 questions)
4. Understand the application of sterile (aseptic) techniques.
5. Develop, evaluate, and document exposure control procedures
for biohazardous agents and materials.
6. Develop procedures and practices to prevent release of
infectious aerosols from equipment.
7. Perform biosafety audit of work practices and procedures
associated with large-scale operations.
8. Understand and apply monitoring techniques and equipment to
determine effectiveness of exposure control measures and to
investigate environmental problems.
9. Understand use and disposal of sharps.
10. Select and understand use of personal protective equipment.
11. Select and understand use of respiratory equipment.
12. Develop and implement procedures for managing biohazardous
spills and releases.
13. Assure documentation of worker exposure to biohazardous
materials and preparation of an incident report.
14. Develop comprehensive emergency response plan for biohazard
areas.
III. RISK ASSESSMENT AND HAZARD
IDENTIFICATION — INFECTIOUS AGENTS AND
RECOMBINANT DNA (33 questions)
15. Demonstrate knowledge of personal risk factors associated with
microbial exposure.
16. Assess the risk of occupational exposure and infection
associated with handling infectious agents.
17. Demonstrate familiarity with routes of exposure, modes of
transmission, and other criteria that determine the hazard
category of a microorganism.
18. Assess the risk to the community from various work
environments where infectious agents or sensitizing materials
may be present.
19. Demonstrate understanding of microbial toxins and their
potential to cause work-related illness.
20. Demonstrate the ability to recognize the characteristics of
bacteria, viruses, fungi, and parasites.
21. Understand the hazard of exposure of service personnel to
biological materials.
22. Understand factors that may affect susceptibility, resistance, or
consequences of infection.
23. Understand the difference between risk of infection and
consequences of infection.
24. Understand the risk associated with biological aerosols in the
workplace, such as ventilation, indoor air quality, recirculation,
and cooling towers.
25. Understand the risk associated with point=source release of
biological aerosols in the workplace, such as from
homogenizers, cell sorters, centrifuges, fermenters, and lasers.
26. Understand the risks associated with recombinant DNA
technology.
27. Demonstrate knowledge of unique biosafety conditions
associated with naturally or experimentally infected animals,
including nonhuman primates.
IV. REGULATORY ASPECTS, STANDARDS AND
GUIDELINES (32 questions)
28. Interpret and apply the NIH Guidelines for research involving
recombinant DNA molecules.
21
29. Interpret and apply OSHA Bloodborne Pathogens standard.
30. Interpret and apply guidelines that classify biohazardous agents
according to risk.
31. Interpret and apply guidelines for preventing transmission of
Mycobacterium tuberculosis in the workplace.
32. Interpret and apply regulations for packing, labeling, and
shipping of infectious materials, diagnostic specimens, and
medical waste.
33. Interpret and apply import and export requirements associated
with biological materials.
34. Interpret and apply regulations associated with animal
pathogens.
35. Interpret and apply guidelines associated with the large-scale
use of microorganisms.
36. Interpret and apply the National Sanitation Foundation standard
on (laminar class II flow) biohazard cabinetry (NSF 49).
37. Interpret and apply OSHA law, standards, and directives as they
relate to biohazards.
38. Interpret and apply guidelines and regulations relating to
infectious and medical waste.
39. Demonstrate familiarity with agencies, their role and relationship
with biosafety, such as WHO, CDC, NIH, OSHA, AAALAC, DOT,
IATA, ICAO, DOD, EPA, USDA, and FDA.
40. Interpret and apply the CDC-NIH Biosafety in microbiological and
biomedical laboratories document and other pertinent CDC
publications.
V. PROGRAM MANAGEMENT AND DEVELOPMENT
(22 questions)
41. Understand the role and function of an institutional biosafety
committee.
42. Prepare and maintain a biosafety manual.
43. Review project proposals and advise on biosafety issues.
44. Advise on occupational health programs for persons working
with biological materials.
45. Provide and interpret biosafety resource and reference
information.
46. Organize and implement institutional biosafety compliance
programs and audit their effectiveness.
47. Institute, evaluate, and document biosafety training.
22
48. Identify biological agents and materials in your institution.
49. Develop and implement an infectious-medical waste
management program.
50. Provide technical information and advice on products impacting
biological safety.
51. Develop and recommend biosafety policies.
VI. EQUIPMENT OPERATION AND CERTIFICATION
(23 questions)
52. Understand the use and validation of a steam autoclave.
53. Understand the use and certification of biological safety cabinets
(BSCs).
54. Demonstrate knowledge of class I, II, and III BSC design
features, applications, and functions.
55. Understand the calibration and use of air-measuring instruments
to verify the safe operation of biological safety equipment.
56. Understand the design, function, and efficiency of HEPA filters.
57. Understand the limitations in the use of equipment for work with
biohazardous materials such as fume hoods and clean benches.
58. Understand the use and validation of sterilizers using ethylene
oxide (ETO) and vaporized hydrogen peroxide.
59. Understand the equipment and chemicals used for space
decontamination.
60. Understand the use and applicability of animal containment
equipment.
VII. FACILITY DESIGN (8 questions)
61. Understand the functions and indications for use of primary and
secondary barriers.
62. Understand the difference and appropriateness of facility design
to balance the need for hazard containment, personal product,
and environmental protection.
63. Review architectural and engineering plans and advise on
biosafety issues.
64. Verify that facilities as built meet minimum biosafety design
criteria.
Biosafety Sample Questions
1. What common laboratory items, when mixed, will cause an
explosion?
a. Hypochlorite, cotton, heat
b. Cellulose nitrate, a refrigerator, a centrifuge
c. Perchloric acid (2%), a brown colored glass container, an
aula bag
d. Ethyl alcohol, dry ice, a stainless steel beaker
Corresponds to Task #2.
2. Packaged laboratory equipment cannot be sterilized by:
a. steam.
b. gamma radiation.
c. ETO.
d. UV radiation.
e. dry heat.
Corresponds to Task #3.
3. UV germicidal lamps may be installed in the work chamber of
class II BSCs because the lamps:
a. may provide some work surface decontamination.
b. decontaminate the air exhausted from the BSC.
c. decontaminate the air being recirculated in the BSC.
d. are required by NSF 49.
e. decontaminate the supply air.
Corresponds to Task #3.
4. Which of the following practices would fail to provide personnel
protection during the use of a biological safety cabinet?
a. Locate aerosol producing equipment at the rear of the
cabinet.
b. Move all materials away from the front cabinet grille.
c. Move bulky items to one side of the cabinet.
d. Perform manipulations so that work flows across the work
surface from the contaminated area to the clean area.
e. Avoid frequent inward and/or outward hand movement from
the cabinet.
Corresponds to Task #4.
5. Of the following practices, all are done to prevent worker
exposure to aerosols EXCEPT:
a.
b.
c.
d.
opening the centrifuge safety cup only in the BSC.
balancing the safety cup prior to placing it in the centrifuge.
opening the centrifuge rotor only in the BSC.
wiping the outside of the rotor with disinfectant prior to
removing it from the BSC.
Corresponds to Task #4.
6. Which of the following sampling methods is the most appropriate
for determining microbial contaminants on surfaces?
a. Sieve sampler
b. Settling plate
c. All-glass impinger
d. RODAC plate
e. Slit-to-agar sampler
Corresponds to Task #8.
23
7. Occupational infections with Shigella sonnei in laboratory
workers handling cultures or infected clinical materials would
MOST likely be by:
a. parenteral inoculation.
b. ingestion.
c. infectious aerosols.
d. direct or indirect contamination of mucous membranes.
e. direct or indirect contamination of skin.
Corresponds to Task #16.
8. The most probable mode of transmission of occupational
infections with Histoplasma capsulatum in laboratory workers
handling soil samples is:
a. parenteral inoculation.
b. ingestion.
c. infectious aerosolization.
d. direct or indirect contamination of mucous membranes.
e. direct or indirect contamination of skin.
Corresponds to Task #16.
9. The respiratory ID50 (number of organisms required to produce
infection in half of individuals exposed) for Mycobacterium
tuberculosis is on the order of:
a. <10.
b. 100.
c. 1,000.
d. 10,000.
Corresponds to Task #17.
10. Which statement is true about herpesvirus simiae (monkey B
virus)?
a. It infects only New World monkeys and humans.
b. It can be deadly for humans, while monkeys show only minor
symptoms.
c. It is found predominantly in Old World monkeys.
d. It is never found in rhesus monkeys.
e. It causes death in humans after exposure.
Corresponds to Task #17.
24
11. An antimicrobial agent with a phenol coefficient of 5 is:
a. five times as effective as phenol.
b. effective in 5 minutes.
c. effective at a 5% dilution.
d. one-fifth as effective as phenol.
Corresponds to Task #17.
12. A laboratory used for Q fever research was washed down with a
quaternary ammonium compound. What is the risk of infection to
laboratory or visiting personnel?
a. The risk is minimal.
b. The risk to nonvaccinated personnel is significantly elevated.
c. The risk to vaccinated personnel is nonexistent.
d. The risk to personnel not previously exposed is high.
e. There is no risk to visitors or laboratory personnel.
Corresponds to Task #21.
13. Plumbers servicing laboratories with lead, copper, or brass sink
traps may encounter explosion hazards associated with the
disposal of which of the following chemicals in the laboratory
sink?
a. Sodium carbonate
b. Sodium hydroxide
c. Sodium borate
d. Sodium azide
e. Sodium hypochlorite
Corresponds to Task #21.
14. Which of the following organisms has NOT been implicated as a
hazard associated with indoor air quality?
a. Escherichia coli K-12
b. Legionella pneumophila
c. Aspergillus fumigatus
d. Dust mites
e. Pseudomonas cepacia
Corresponds to Task #24.
15. What potential zoonotic pathogen is in risk group 4?
a. Coxiella burnetii
b. Herpesvirus simiae
c. Chlamydia psittaci
d. Eastern equine encephalitis
Corresponds to Task #27.
16. A laboratory worker must grind fresh human tissue to process for
a specific DNA test. In order to minimize the potential exposure
to the laboratory worker and to comply with the OSHA
Bloodborne Pathogen standard, which precaution is MOST
important?
a. Gloves must be worn during the procedure.
b. The work area must be decontaminated with a mycobacterial
disinfectant.
c. The procedure must be performed using a splash shield or
inside a biological safety cabinet.
d. An N95 respirator must be worn.
e. Goggles must be worn when performing the procedure.
Corresponds to Task #29.
17. According to Appendix H of the recombinant DNA guidelines,
recombinant DNA (RDNA) molecules contained in an organism
or in a viral genome shall be shipped under the applicable
regulations of the appropriate federal agencies as infectious
substances (etiologic agents) regardless of whether not they
contain RDNA, if they are regulated as human pathogens by the:
a. DOT, Code of Federal Regulations, title 49, sections 171–
179 (49 CFR 171–179).
b. CDC, CFR 42 CFR 72.
c. OSHA, 29 CFR 1910.
d. USPS, 39 CFR 3.
Corresponds to Task #32.
18. Following a petition by the industry involved, a special provision
of DOT shipping regulations provided an exemption for the
amount of what material which could be carried by air?
a. Biological products
b. Infectious substances
c. Clinical and/or diagnostic specimens
d. Medical wastes
e. Sampling kits for home use
Corresponds to Task #32.
19. Which foreign disease agent may be used on the United States
mainland?
a. Nipah virus
b. Foot-and-mouth disease virus
c. Lumpy skin disease virus
d. Hog cholera virus
e. Rinderpest virus
Corresponds to Task #34.
20. A BSC has an 8-inch by 4-foot access opening. The cabinet
recirculates 30% and exhausts 70% of the supply air. How many
cubic feet per minute (CFM) of air must be exhausted for the
cabinet to have a 100 linear foot per minute (LFM) average
intake velocity?
a. 80.0
b. 186.4
c. 266.4
d. 381.4
e. 533.4
Corresponds to Task #36.
25
21. Medical waste generated in hospitals accounts for more than
what percentage of all medical waste generated?
a. 25%
b. 40%
c. 60%
d. 75%
e. 90%
Corresponds to Task #38.
22. Individuals are restricted or prohibited from discarding a culture f
pathogenic organisms directly into the sewer system according
to:
a. local or state regulations.
b. CDC regulations.
c. USDA regulations.
d. OSHA regulations.
e. EPA regulations.
Corresponds to Task #39.
23. According to the IATA Dangerous Goods Regulations, the
maximum amount of liquid infectious substance in any one
package allowable for transport on a passenger aircraft is:
a. 5 ml.
b. 50 ml.
c. 500 ml.
d. 4,000 ml.
e. none.
Corresponds to Task #39.
26
24. In a class II, type B3 BSC:
a. the minimum inward air flow is 75 LFM and the exhaust air is
ducted.
b. any leakage in a contaminated plenum is to the outside of
the cabinet.
c. all negative-pressure contaminated plenums within the
cabinet are surrounded by a positively pressured plenum.
d. all positive-pressure contaminated plenums within the
cabinet are surrounded by a negatively pressured plenum.
e. exhaust air can be recirculated into the laboratory.
Corresponds to Task #54.
ANSWERS
1.
2.
3.
4.
5.
a
d
a
d
b
6.
7.
8.
9.
10.
d
b
c
a
c
11.
12.
13.
14.
15.
a
d
d
a
b
16.
17.
18.
19.
20.
c
b
d
a
c
21.
22.
23.
24.
a
a
b
d
RESOURCES
Critical References
Occupational Safety and Health Administration, Office of Health
Compliance Assistance. 1996. Enforcement procedures and
scheduling for occupational exposure to tuberculosis. CPL 02-00106. Occupational Safety and Health Administration, Washington,
D.C.
Dooley, S.W., Jr., K. G. Castro, M. D. Hutton, R. J. Mullan, J. A.
Polder, and D. E. Snider, Jr. 1990. Guidelines for preventing the
transmission of tuberculosis in health-care settings, with special
focus on HIV-related issues. Morb. Mortal. Wkly. Rep. 39(RR-17):1–
29.
Richmond, J. Y., and R. W. McKinney (ed.). 1999. Biosafety in
microbiological and biomedical laboratories, 4th ed. U.S. Department
of Health and Human Services, Centers for Disease Control and
Prevention, and National Institutes of Health. U.S. Government
Printing Office, Washington, D.C.
Fleming, D. O., and D. L. Hunt (ed.). 2000. Biological safety:
principles and practices, 3rd ed. ASM Press, Washington, D.C.
Richmond, J. Y., and R. W. McKinney (ed.). 2000. Primary
containment for biohazards: selection, installation and use of
biological safety cabinets, 2nd ed. U.S. Department of Health and
Human Services, Centers for Disease Control and Prevention, and
National Institutes of Health. U.S. Government Printing Office,
Washington, D.C.
National Institute for Occupational Safety and Health. 1999. TB
respiratory protection program in health care facilities: administrator’s
guide. U.S. Department of Health and Human Services, Public
Health Service, Centers for Disease Control and Prevention.
National Institute for Occupational Safety and Health, Cincinnati,
Ohio.
National Institutes of Health. 2002. NIH guidelines for research
involving recombinant DNA molecules. U.S. Department of Health
and Human Services, National Institutes of Health. U.S. Department
of Health and Human Services, Washington, D.C.
National Research Council. 1996. Guide for the care and use of
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Helpful References
American Industrial Hygiene Organization. 1995. Biosafety
reference manual, 2nd ed. American Industrial Hygiene Organization,
Fairfax, Va.
World Health Organization. 2003. Laboratory biosafety manual, 2nd
ed., rev. World Health Organization, Geneva, Switzerland.
National Sanitation Foundation. 2003. NSF 49 class II (laminar
flow) biosafety cabinetry. NSF/ANSI 49-02e. NSF International, Ann
Arbor, Mich.
Occupational Safety and Health Administration. 2003.
Bloodborne pathogens. Title 29, Code of Federal Regulations,
section 1910.1030 (29 CFR 1910.1030). U.S. Government Printing
Office, Washington, D.C.
27
Internet
ABSA. http://www.absa.org.
CDC. http://www.cdc.gov.
OSHA. http://www.osha.gov.
Agency and organization abbreviations used in this section
AAALAC, Association for Assessment and Accreditation of
Laboratory Animal Care, International
ABSA, American Biological Safety Association
CDC, Centers for Disease Control and Prevention
DOD, Department of Defense
DOT, Department of Transportation
EPA, Environmental Protection Agency
FDA, U.S. Food and Drug Administration
IATA, International Air Transport Association
ICAO, International Civil Aviation Organization
NIH, National Institutes of Health
OSHA, U.S. Occupational Safety and Health Administration
USDA, U.S. Department of Agriculture
USPS, U. S. Postal Service
WHO, World Health Organization
28