LAARC Users Guide 508

Laboratory Assessment of Antibiotic
Resistance Testing Capacity

User’s Guide and Questionnaire
VERSION 2.0
AUGUST 2020
Division of Healthcare Quality Promotion
CS320242-A
LAARC User’s Guide and Questionnaire
Version 2.0
August 2020
The Laboratory Assessment of Antibiotic Resistance Testing Capacity is a publication of the Division of
Healthcare Quality Promotion in the National Center for Emerging and Zoonotic Infectious Diseases within the
U.S. Centers for Disease Control and Prevention (CDC).
U.S. Centers for Disease Control and Prevention

Robert Redfield, MD, Director
National Center for Emerging and Zoonotic Infectious Diseases

Rima Khabbaz, MD, Director

Denise Cardo, MD, Director
Photo Credit: Daniella Coker

Cover page photo features (l-r) Dr. Hein Bui of CDC, Vietnam; Mr. Truong Nguyen, a healthcare informatics
consultant in Vietnam; and Dr. Mai Van Tuan, a clinical microbiologist in Hue, Vietnam. They are examining a
lidded and sealed non-infectious petri dish in an anteroom of a non-CDC laboratory in Vietnam.
Suggested citation:
Centers for Disease Control and Prevention. Laboratory Assessment of Antibiotic Resistance Testing Capacity.
Atlanta, GA: U.S. Department of Health and Human Services, CDC; 2020. Available at:
https://www.cdc.gov/drugresistance/intl-activities/laarc.html.
Version 2 | August 2020 Page 1 of 90

ACKNOWLEDGEMENTS
Susan Bollinger (International Infection Control Program, Division of Healthcare Quality Promotion, U.S. Centers
for Disease Control and Prevention, Atlanta, Georgia, USA) led the overall development of the LAARC
questionnaire and coordinated the piloting and revision of the tool in collaboration with internal and external
stakeholders. She also provided expert subject matter input to the development of the Excel scoring tool. Sonya
Arundar and Joyce Thomas (Division of Healthcare Quality Promotion, CDC) provided professional editing (plain
language and usability) assistance.
Antoine Pierson (Integrated Quality Laboratory Services, IQLS, Lyon, France) led the development of the Excel
scoring tool and provided expert subject matter input on the LAARC content to optimize the use of the scoring
tool. Additional support was provided by Abdoulaye Nikièma (IQLS).
The following experts participated in technical consultations to guide the development and provided technical
review of the tool: Rachel Smith, Ulzii Luvsansharav, Nora Chea, Michael Omondi, T.J. McKinney (Division of
Healthcare Quality Promotion, CDC), Michele Parsons (Division of Global Health Protection, CDC).
The following experts piloted the tool in resource-limited settings and provided technical expertise and
feedback: Nino Macharashvili, Lan Nguyen, Hien Bui, Valan Siromany, Wangeci Gatei, Molly Freeman, Pawan
Angra (Division of Global Health Protection, CDC). Lynee Galley, Emma Muir, Martin Evans, John TarBush, John
Aldom, Abdul Chagla, Vlademir Cantarelli, Victor Silva, American Society for Microbiology (ASM); Mona ElShokry,
Dana Itani, Walaa Khater, the World Health Organization (WHO); and Lindsey Shields, Rogers Kisame, Moctar
Mouiche, (FHI360).
Funding for the development of the Excel scoring tool was provided by the Division of Global Health Protection
in the Center for Global Health through a Cooperative Agreement.
DISCLAIMERS
All rights reserved. Publication of the Centers for Disease Control and Prevention is available on the U.S. CDC
website Lab Assessment of Antibiotic Resistance Testing Capacity (LAARC)
(https://www.cdc.gov/drugresistance/intl-activities/laarc.html) or can be obtained from Centers for Disease
Control and Prevention, 1600 Clifton Rd., Atlanta, GA, 30329, USA (email: IICP@cdc.gov).
The mention of specific companies or of certain manufacturers’ products does not imply that they are endorsed
or recommended by the Centers for Disease Control and Prevention in preference to others of a similar nature
who are not mentioned. Errors and omissions excepted, the names of proprietary products are distinguished by
initial capital letters.
The contents of the LAARC are solely the responsibility of the authors and do not necessarily represent the official
views of the U.S. Centers for Disease Control and Prevention. All reasonable precautions have been taken to
verify the information contained in this publication. However, the published material is being distributed without
warranty of any kind, either expressed or implied. The responsibility for the interpretation and uses of the
material lies with the reader. In no event shall the Centers for Disease Control and Prevention or IQLS be liable for
damages arising from its use.

TABLE OF CONTENTS
ACKNOWLEDGEMENTS ..............................................................................................................................................2
DISCLAIMERS ..............................................................................................................................................................2
TABLES AND FIGURES .................................................................................................................................................4
ACRONYMS .................................................................................................................................................................5
EXECUTIVE SUMMARY................................................................................................................................................7
1. INTRODUCTION.................................................................................................................................................7
1.1. Rationale .................................................................................................................................................7
1.2. Purpose ...................................................................................................................................................7
1.3. Scope .......................................................................................................................................................8
2. ASSESSMENT PLANNING and PREPARATION ................................................................................................ 10
2.1. Assessment Team ................................................................................................................................ 10
2.2. Team Preparation ................................................................................................................................ 10
2.3. Laboratory Preparation........................................................................................................................ 11
2.4. Assessment Process ............................................................................................................................. 11
2.4.1. Take GPS Location ...................................................................................................................... 11
2.4.2. Meet with staff........................................................................................................................... 11
2.4.3. Tour the laboratory .................................................................................................................... 12
2.4.4. Review Documents and Fill the Questionnaire .......................................................................... 12
2.4.5. Professionalism .......................................................................................................................... 12
3. LAARC TOOL STRUCTURE............................................................................................................................... 13
3.1. Files ...................................................................................................................................................... 13
3.2. Excel File Organization ......................................................................................................................... 13
3.2.1. Yellow: ....................................................................................................................................... 13
3.2.2. Blue: Questionnaire (15 tabs) .................................................................................................... 13
3.2.3. Questionnaire Organization and Structure ................................................................................ 14
3.2.4. Red: ........................................................................................................................................... 15
4. ENTERING DATA INTO THE EXCEL TOOL ........................................................................................................ 16
4.1. Generate a Unique Filename ............................................................................................................... 16
4.2. Select Language ................................................................................................................................... 16
4.3. Answer Questions ................................................................................................................................ 16
4.3.1. Drop-down boxes ....................................................................................................................... 16
4.3.2. Free-text cells and Comment cells ............................................................................................. 17
4.3.3. Color Coding ............................................................................................................................... 17
5. SCORING SYSTEM........................................................................................................................................... 18
5.1. Questions ............................................................................................................................................. 18

5.2. Indicators and Modules ....................................................................................................................... 18
5.3. Flags ..................................................................................................................................................... 19
6. RESULTS: SUMMARY, FLAGS, CONCLUSION and PHOTOS ............................................................................ 20
6.1. Summary tab ........................................................................................................................................ 20
6.2. Flag tab................................................................................................................................................. 20
6.3. Conclusion tab ..................................................................................................................................... 21
6.4. Photograph tab .................................................................................................................................... 21
7. INTERPRETING RESULTS and DEVELOPING A WORK PLAN ........................................................................... 21
8. EXPORTING DATA .......................................................................................................................................... 22
9. REFERENCES ................................................................................................................................................... 24
Appendix 1: Sample Letter ...................................................................................................................................... 25
Appendix 2: Recommended resources.................................................................................................................... 27
Culture and Identification .............................................................................................................................. 27
AST/AMR ........................................................................................................................................................ 27
Quality Control............................................................................................................................................... 27
Laboratory Quality Management Systems (QMS) ......................................................................................... 27
Laboratory Biosafety...................................................................................................................................... 28
Appendix 3: LAARC Questionnaire .......................................................................................................................... 29
TABLES AND FIGURES

Table 1: GLASS priority specimens and pathogens for surveillance of AR .................................................................8
Table 2: GLASS priority pathogen-antimicrobial combinations for surveillance of AR by priority pathogen ............9
Table 3: Sample agenda........................................................................................................................................... 11
Table 4: LAARC Questionnaire Modules.................................................................................................................. 13
Table 5: Description of Module Structure ............................................................................................................... 15
Figure 1: Module architecture and organization..................................................................................................... 15

Figure 2: Numeric Responses .................................................................................................................................. 17
Figure 3: Example of a clarifying comment ............................................................................................................. 17
Figure 4: Color coding in the Module tabs .............................................................................................................. 17
Figure 5: Module and Indicator score examples ..................................................................................................... 18
Figure 6: Question, Indicator, and Module Scoring ................................................................................................ 19
Figure 7: Flag Examples ........................................................................................................................................... 20
Figure 8: Color coded heat map for the Module: Safety Appendix and its four Indicators .................................... 20
Figure 9: Flag Tab..................................................................................................................................................... 21
Figure 10 : Geographical representation of indicators ........................................................................................... 23

ACRONYMS
Abbreviation Term
AMR/AR Antimicrobial Resistance
AST Antibiotic Susceptibility Testing
ATCC American Type Culture Collection
BMD Broth microdilution
BSL Biosafety Level
CAP College of American Pathologists
CDC U.S. Centers for Disease Control and Prevention (Atlanta)
CIP Collection de l'Institut Pasteur
CLSI Clinical & Laboratory Standards Institute
CRE Carbapenem-Resistant Enterobacteriaceae
CSF Cerebrospinal Fluid
CSV Comma Separated Value
EQA External Quality Assessment
ESBL Extended-spectrum beta-lactamase
EUCAST European Committee on Antimicrobial Susceptibility Testing
GHSA Global Health Security Agenda
GLASS Global Antimicrobial Resistance Surveillance System
GPS Global Positioning System
HIS Hospital Information System
ICR Inducible Clindamycin Resistance
ID Identification
ILAC International Laboratory Accreditation Cooperation
IQLS Integrated Quality Laboratory Services
ISO International Standardization Organization
LAARC Laboratory Assessment of Antimicrobial Resistance Testing Capacity
LIS Laboratory Information System
LQSI Laboratory Quality Stepwise Implementation
MALDI Matrix Assisted Laser Desorption Ionization
MCIM Modified carbapenem inactivation method
MIC Minimal Inhibitory Concentration
MRSA Methicillin-Resistant Staphylococcus aureus
NA Not Applicable
NCTC National Collection of Type Cultures
NLF Non-Lactose Fermenting
NRL National Reference/Referral Laboratory
PCR Polymerase Chain Reaction
PPE Personal Protective Equipment
PT Proficiency Testing
QA Quality Assurance
QC Quality Control
QMS Quality Management Systems
SLIPTA Stepwise Laboratory Quality Improvement Process Towards Accreditation
SOP Standard Operating Procedure

Abbreviation Term
STD Sexually Transmitted Disease
TB Tuberculosis
VISA Vancomycin-Intermediate Staphylococcus aureus
VRE Vancomycin-Resistant Enterococci
VRSA Vancomycin-Resistant Staphylococcus aureus
WHO World Health Organization

EXECUTIVE SUMMARY
The Laboratory Assessment of Antibiotic Resistance Testing Capacity (LAARC) was designed for use in resource
limited settings to:
• Evaluate the technical skill and expertise of clinical bacteriology laboratories
• Evaluate the quality management practices related to bacterial identification and antibiotic susceptibility
testing (AST)
• Generate numerical indicators of quality and capacity in fifteen domains of laboratory practice
• Aid development of workplans for improvement
• Monitor the status of laboratory improvements over time
The specimen types, organisms and antibiotics

Questionnaire content is based on internationally
addressed by the tool are based on the priorities set accepted standards of clinical laboratory practice
by WHO Global Antimicrobial Resistance Surveillance including:
System (GLASS) in 2015. • International Organization for Standardization
(ISO)
Assessments using the LAARC require two full days to
• European Committee on Antimicrobial
complete. Due to the technical nature of the
Susceptibility Testing (EUCAST)
questions, assessments must be carried out by
• Clinical & Laboratory Standards Institute (CLSI)
bacteriologists with ample AST experience and strong
• The World Health Organization (WHO)
familiarity with clinical bacteriology laboratory
requirements and standards, which may differ from
research, industrial, environmental or veterinary laboratory standards.
The LAARC scoring tool is a Microsoft (MS) Excel® file. It does not contain macros, thus, it can be used on any
computer and works independently from operating system type and language. The tool is currently available in
English, French, Spanish, and Portuguese. Additional languages may be added to the translation table by the
end-user, including non-Latin alphabets.
1. INTRODUCTION
Control of antibiotic resistance (AR) is a global public health priority. Strong AR laboratory networks are
critical to inform policy and control efforts. Such networks often obtain AR data from clinical laboratories;
thus, the usefulness of the aggregate data largely depends on the ability of the laboratories to produce
accurate and reliable bacterial identification (ID) and antibiotic susceptibility testing (AST) results.
1.1 Rationale
Many existing laboratory assessment tools are designed to evaluate the quality management system
(QMS) requirements described by international laboratory standards organizations (e.g., ISO and
CLSI). These tools are inadequate to detect deficiencies in bench-level testing because they lack
technical depth and granularity. The LAARC assessment tool is designed to fill that technical gap and
is specifically adapted for laboratories in low- and middle- income countries which have not yet
established comprehensive laboratory regulations and/or accreditation requirements. The tool
contains extensive Quality Control (QC) and Quality Assurance (QA) questions, but it is primarily
technical in nature and does not provide a comprehensive QMS assessment.
1.2 Purpose
The purpose of the LAARC is to objectively evaluate technical proficiency in the bacteriologic
techniques and related quality processes that are required for accurate, reliable AR detection. Results

provide a clear pathway toward improvement. The LAARC was designed for use in hospital-based
laboratories that receive and process clinical specimens for the purposes of routine patient care.
National reference laboratories (NRLs) and other public health laboratories will benefit from the
technical assessment, but may find certain sections, such as Specimen Collection, less relevant.
Other areas of importance to public health laboratories and institutions are not addressed by this
tool, such as:
• Molecular testing capacity and other advanced techniques (PCR, sequencing, MALDI)
• Packaging, shipping, transport, receiving, and storage following testing
• Participation in laboratory-based surveillance systems (e.g., STDs, TB, enterics, vaccine escape, AR)
• Funding and budget
• Non-laboratory personnel: epidemiologists, data managers and analysts, administrative support staff
• Public health roles: Notifiable Diseases, Outbreak response, provider of EQA/PT
A survey 1 addressing several of these topics was developed by WHO and is publicly available for use
in conjunction with the LAARC to comprehensively assess the AR capacity of NRLs. The LAARC does
not assess the readiness of the national health system to implement AR surveillance. Multiple WHO
tools 2,3,4,5 are available to assess national health systems.
1.3 Scope
The LAARC was built around the WHO priority AR specimen types, pathogens and antibiotics included in
their Global Antimicrobial Resistance Surveillance System (GLASS) initiative of 2015; see Tables 1 and 2.
Table 1: GLASS priority specimens and pathogens for surveillance of AR

Priority Specimens Priority pathogens for surveillance
Blood Escherichia coli
Klebsiella pneumoniae
Acinetobacter baumannii *
Staphylococcus aureus
Streptococcus pneumoniae
Salmonella spp.
Urine Escherichia coli
Feces/Stool Salmonella spp.
Shigella spp.
Urethral and cervical swabs Neisseria gonorrhoeae †
*
Many labs are unable to definitively differentiate Acinetobacter calcoaceticus from A. baumannii, so in practice this refers to
Acinetobacter calcoaceticus-baumannii complex
†
N. gonorrhoeae was excluded from this tool due to the complexities involved with routine culture and recovery, identification and
AST, and the existence of other surveillance networks and STD clinics dedicated exclusively to this pathogen.
1 Laboratory Assessment Questionnaire for Antimicrobial Resistance Testing (https://extranet.who.int/dataform/549586?lang=en)

2
WHO AR Surveillance Questionnaire for Assessment of National Networks [PDF - 24 pages] (https://www.who.int/antimicrobial-
resistance/whocdscsrrmd20031.pdf)
3
WHO Laboratory Assessment Tool / System Questionnaire [PDF - 42 pages] (https://www.who.int/ihr/publications/Annex1_LAT.pdf)
4
WHO GLASS Implementation Questionnaire [PDF - 6 pages] (http://apps.who.int/iris/bitstream/10665/251558/1/WHO-DGO-AR-
2016.10-eng.pdf)
5
WHO GLASS Core Components Checklist [PDF - 35 pages] (https://apps.who.int/iris/bitstream/handle/10665/251552/WHO-DGO-AMR-
2016.5-eng.pdf)

Table 2: GLASS priority pathogen-antimicrobial combinations for surveillance of AR
by priority pathogen
The antibiotics listed below are important for AR surveillance purposes. However, they may not be
first-line options for testing or for treatment and should not be interpreted as such.
Staphylococcus aureus
Antibacterial class Antibacterial agents
Penicillinase-stable beta-lactams Cefoxitin
Streptococcus pneumoniae
Penicillins Oxacillin (as a screen for Penicillin resistance)
Penicillin G
Sulfonamides and Trimethoprim Co-trimoxazole
Third-generation cephalosporins Ceftriaxone or cefotaxime
Escherichia coli
Penicillins Ampicillin
Third-generation cephalosporins Ceftriaxone or Cefotaxime + Ceftazidime
Fourth-generation cephalosporin Cefepime
Carbapenems Imipenem, Meropenem, Ertapenem, Doripenem
Fluoroquinolones Ciprofloxacin or Levofloxacin
Polymyxins Colistin
Penicillins Ampicillin
Fourth-generation cephalosporin Cefepime
Polymyxins Colistin
Acinetobacter baumannii
Aminoglycosides Gentamicin and Amikacin
Carbapenems Imipenem, Meropenem, Doripenem
Tetracyclines Tigecycline or Minocycline
Polymyxins Colistin

Salmonella spp.
Shigella spp.
Macrolides Azithromycin
Neisseria gonorrhoeae
Aminocyclitols Spectinomycin
Aminoglycosides Gentamicin
Fluoroquinolones Ciprofloxacin
Macrolide Azithromycin
Third-generation cephalosporins Cefixime and Ceftriaxone
Additional culture types, pathogens and antibiotics may be assessed pursuant to national priorities;
however, the current iteration of this tool focuses only those listed in Tables 1 and 2. Users cannot
edit or modify.
2. ASSESSMENT PLANNING and PREPARATION
2.1 Assessment Team

Due to the highly technical nature of the questions, assessments are most effective when carried out
in conjunction with a clinical bacteriologist. This person should be well experienced in the full range
of clinical bacteriology laboratory practices, from specimen collection to AST, and the standard
quality practices associated with each step.
Ideally, all team members, including translators, would have a background in bacteriology laboratory
practices and the general operations of hospitals and clinical laboratories. Preferably, assessors will
also have previous experience with performing laboratory assessments. Persons with expertise that is
primarily research-based or that is grounded in other areas of microbiology (e.g., parasitology,
virology) are not ideal.
2.2 Team Preparation

Read the User’s Guide in full and review all LAARC questions in advance to establish familiarity with
the contents. Seek clarification if needed, decide how to allocate the work, and prepare a translation
if necessary. The questionnaire is provided in both PDF (Appendix 3) and Excel formats. Print the PDF
(approximately 70-80 pages depending on the language) for paper data collection and subsequent
data entry into the Excel tool. Or, enter answers directly into the Excel tool during the assessment.
Allow two full days to complete each assessment. The assessment must be carried out during
laboratory operating hours to observe staff at work. A sample agenda follows:
Table 3: Sample agenda
Day 1 Day 2
8:00 – 8:30 am 7:30 – 09:30 am
• Introductions: Laboratory leadership, other • Observe laboratory staff at the bench
laboratory staff, and the assessment team • Continue filling assessment
• Review purpose of the evaluation and 9:30 – 10:00 am
expected timeline • Break for tea
8:30 – 9:30 am 10:00 am – Noon
• Tour laboratory • Continue filling assessment
• Begin review of pre-assembled documents, Noon – 1:00 pm
begin filling tool • Break for lunch
9:30 – 10:00 am 1:00 – 2:30 pm
• Break for tea • Complete assessment
10:00 am – Noon 2:30 – 3:30 pm
• Continue filling assessment • Summation/exit meeting with laboratory
Noon– 1:00 pm leadership, other relevant staff
• Break for lunch
1:00 – 4:30 pm
• Continue filling assessment
Useful (but not required) items include:

• Digital camera: obtain permission before taking photos; avoid capturing patient identifiers
• GPS device: for GPS positioning (can also be performed using a smartphone application)
• Small infrared thermometer: to rapidly check temperatures of refrigerators, rooms, incubators
• Video projector: to share final results with the team, if a projector is not available at the facility
2.3 Laboratory Preparation

At least one week in advance of the assessment, share an agenda with the laboratory so that they
know what to expect and can plan accordingly. Request that the laboratory preassemble key
documents and manuals for review; doing so will save a significant amount of time during the actual
assessment. There is a sample letter containing an agenda and a list of key documents in Appendix A;
send this letter to the laboratory at least one week in advance of the assessment.
2.4 Assessment Process

2.4.1. Take GPS Location
GPS coordinates are not essential but may be useful, especially if performing multiple assessments
throughout a country. Record GPS position in digital degrees, using a GPS device or a smartphone
application. It is also possible to get latitude and longitude from Google Maps®, (but not altitude):
1. Right-click the location on the map
2. Select “What’s here?”
3. A card with latitude (first position) and longitude (second position) will display at the bottom
• If using Maps in “Lite mode,” you’ll see a lightning bolt at the bottom and you won’t be able
to get the coordinates.
4. Record digital degrees to 5 decimals and the + or – sign, if present.
• For example: latitude 41.40338, longitude -2.17403
2.4.2. Meet with staff

Meet briefly with facility and laboratory leadership and staff. Review the agenda and explain the
assessment purpose, process, and expected outcome. Point out that this is not a “regulatory
inspection” intended to penalize the laboratory, but a way to discover areas for improvement and
develop a workplan to achieve it. This meeting is also an opportunity to ask about the laboratory
organizational structure, the population served, and any known management issues (staffing,
procurement, equipment, financing, etc.).
2.4.3 Tour the laboratory

After the preliminary meeting, tour the laboratory in the direction described below. Following this
“sample path” provides insight into the general workflow and is an opportunity to ask questions and
observe general cleanliness, organization, and staff adherence to biosafety practices.
• Patient reception/sampling rooms (if the laboratory collects specimens)

• Specimen receiving area (observe specimen storage, data processes, generation of specimen ID)
• Specimen culture plating area (BSC, incubators, blood culture instruments, direct Gram stain
preparation)
• Culture reading and workup area (Gram staining, benches, reagent refrigerators/freezers)
• ID/AST instruments
• Temporary storage and final disposal of culture plates
• Support rooms (e.g., media preparation room, autoclave room, stock room, glassware washroom,
waste management areas)
2.4.4 Review Documents and Fill the Questionnaire

Upon completion of the tour, begin filling out the LAARC questionnaire. Direct questions to the
laboratory manager, quality manager, and both senior and junior bench technologists.
Documentation is key. Confirm answers whenever possible by reviewing the supporting

documentation. Many questions are intentionally designed to require confirmatory documentation.
For example, the question “Do QC records demonstrate that XXX practice is in place?” demands that
the assessor review the pertinent QC records to determine if they meet the defined criteria. This is a
core tenant of quality systems. Without confirmatory documentation, the answer to the question
must be “no,” even if the laboratory claims that the practice is in place.
Partial credit. Some questions have “partial” responses available, but most are either “yes” or “no” for
simplicity of scoring. It may be tempting to mark a question as “yes” when a laboratory partially meets the
criteria, but if the criteria are not fully met and “partial” is not available, then the answer must be “no.”
Marking the response as “no” creates an opportunity for the laboratory to make the changes needed to
become fully compliant. Marking it as “yes” eliminates this opportunity to improve, which is a disservice
to the laboratory. Use the Comment boxes next to each question to add clarifying information.
Research specimens. Many laboratories have equipment, reagents and SOPs that are used for
research specimens but are not used for routine patient specimens. The questions in the LAARC
questionnaire refer only to the equipment, reagents and SOPs that are used with cultures submitted
for clinical patient management in the routine course of care.
2.4.5 Professionalism
Establishing a good relationship with laboratory personnel is vital if recommendations are to be
received well. Give recommendations and advice in a friendly and supportive manner. If there are
findings that may be embarrassing or upsetting for the laboratory, discuss them in private with the
laboratory manager and those in charge. Always obtain permission prior to taking photographs.

3. LAARC TOOL STRUCTURE
3.1 Files
The tool is a combination of three files:
• PDF file containing the User’s Guide and the LAARC questionnaire for printing (available in each
language: English, French, Spanish, Portuguese)
• Multilingual MS Excel tool for data entry and scoring
• (Optional) MS Excel “export reception” file to consolidate output from multiple assessments for
further analysis by statistical software; available in English only
3.2 Excel File Organization

The MS Excel tool has 25 worksheets (or “tabs”) organized into three groups: yellow, blue, and red.
• Yellow tabs contain introductory information
• Blue tabs contain the LAARC questionnaire
• Red tabs contain the assessment results
• Worksheet tabs are titled in English only
3.2.1 Yellow (5 tabs)
• Cover: Cover page

• Introduction: Contextual information about the development and intended use of the tool.
• Language: Language table and mechanism for selecting desired language. New languages may be
added to column F.
• Registration: Information about optional registration and link to registration webpage.
• Assessor’s guide: Helpful reference materials required to answer specific assessment questions,
including select CLSI and EUCAST breakpoint tables.
3.2.2 Blue: Questionnaire (15 tabs)
The LAARC questionnaire is organized into 15 modules; each module contains 3 to 10 indicators. Each
indicator contains several closed questions.
Table 4: LAARC Questionnaire Modules

# of # of
Modules Indicators Questions
0 General 6 85
Facility demographics, test menu and workload, staffing,
accreditation
1 Facility 9 135
Laboratory conditions, equipment availability, calibration and
maintenance, temperature monitoring, autoclave and inventory
management
2 Laboratory Information System (LIS) 6 46
Detailed questions about data field configuration and connective
capability of electronic data management systems

# of # of
Modules Indicators Questions
3 Data management 7 73
Patient and specimen identification, request forms, culture and
AST data reporting, data backup and sharing
4 QA 4 45
QMS basics, staff competency assessments, troubleshooting
mechanisms and EQA
5 Media QC 6 63
Routine and specialized media preparation and QC, including
Muller Hinton blood culture bottles and distilled water
6 ID QC 4 113
Quality Control of bacterial identification systems, including Gram
stain, manual biochemical methods, enteric serologies,
commercial kits and automated identification systems
7 AST QC 5 49
Quality Control of AST methods including reference strain
maintenance, disc diffusion, gradient strips and automated
systems
8 Specimen 5 59
Collection and transport of blood, urine and stool specifically, plus
general specimen management and rejection
9 Processing 4 30
Plating and inoculation of blood cultures, urine cultures and stool
cultures
10 Identification 10 185
Quality of SOPs for conventional biochemical identification
methods, kits and automated methods; identification flowcharts
11 Basic AST 6 66
Maintenance of discs and strips, inoculum preparation, incubation,
reading and interpreting results and breakpoints standards
12 AST expert rules 10 107
Detailed questions to determine if CLSI and/or EUCAST
breakpoints and AST expert rules for the priority pathogens are
properly applied by the laboratory
13 AST policy 3 33
Selection and application of routine antibiotic panels, cumulative
antibiograms and stewardship
Safety 4 28
Biosafety equipment, safety behaviors, PPE and biosafety training
and documentation
Total 89 1,117
3.2.3 Questionnaire Organization and Structure

Module structure and components are described in the graphic and table below.

Table 5: Description of Module Structure

Number Description
1 Module Name – Module names are in blue; each module is numbered
2 Module Score – Module scores are blue; explained in section 5 of the User’s Guide
3 Comments – Empty cells where you may enter free text comments for each question, if
necessary
4 Indicator Name – Indicators have a black background with white letters
5 Indicator Score – Indicator scores are color coded; explained in section 5
6 Question Numbers – Leading number corresponds to the Module, the second is sequential
Response Cells – Grey cells contain drop-down boxes with the optional responses to each
7
question
8 Question Scores – Question scores are color coded; explained in section 5
9 Flags – Responses to some questions generate “flags”; explained in section 5
3.2.4. Red (5 tabs)
• Summary: Summary of module and indicator scores, workload statistics, equipment summaries,
summary of biochemical identification reagents; four pages when printed
• Flags: Summary of all “Flagged” questions and answers; five pages when printed
• Conclusions: Includes an embedded Microsoft Word document where the assessor may insert their
conclusions in narrative form (recommended); number of pages depends on length of narrative
• Photos: Tab for inserting relevant photographs of the laboratory if desired (six positions); two pages
• Export: Compiles all scores and other select assessment data for optional export into GIS or
statistical analysis software. English only. Must be used in conjunction with Export Reception file

4. ENTERING DATA INTO THE EXCEL TOOL
4.1 Generate a Unique Filename

Before entering any data, save the file using a new filename. This is particularly important when
multiple laboratories are being assessed in order to keep the files distinct. Open the master file, click
“File, Save As.” Select an appropriate location to save the file and assign a new name. The
recommended naming convention is: LAARC_[Name of Laboratory]_[Month & Year of assessment].
Example: “LAARC_CDC Hospital _March 2020.xls.”
4.2 Select Language

The LAARC Excel file contains four language options: English, French, Spanish, and Portuguese. To
select the desired language, go to the Language tab and click the drop-down menu in cell A3, then
select the appropriate number:
• 1 = English
• 2 = French
• 3 = Spanish
• 4 = Portuguese
The entire tool will convert to your selected language, with two exceptions:
• The drop-down menus for responding to each question remain in English and cannot be translated
into other languages.
• The tab labels will remain in English.
Users may add new language translations to column F of the Language tab. The tool will accept Chinese,
Russian, or other left-to-right languages, but it is not well designed to accept Arabic or Persian
languages.
4.3 Answer Questions

4.3.1 Drop-down boxes A simple rule:
Most of the data is entered using drop-down boxes. If you Fill in all the grey cells! Do not
try to type a value into the drop-down box, an error enter values in any other cells,
message will appear. except comment cells.
Click the response box, then click the small arrow at the right side of the cell to open a box containing
the authorized values. The answers to most questions are limited to “yes,” “no,” or “NA” (not
applicable). Select NA if the question doesn’t apply to the laboratory.
For example, if the laboratory does not perform stool cultures, select NA for questions pertaining to
stool cultures. Note: “NA” is not available for all questions, for some it is compulsory to select an
answer. In case of doubts about the appropriate answer, systematically select “no”.
Some questions have a numbered response system (see Figure 2). The corresponding response key is
located below the question; keys are translated into all languages.

4.3.2 Fee-text cells and Comment cells

In the 0-General module, many of the grey cells are free-text, meaning there is no drop-down box.
Answers must be typed into these cells:
• Name of laboratory and key staff
• Assessor names and affiliations
• Number of equipment
• Number of tests performed daily
• Number of technicians
Comment boxes are found next to each indicator and question on all 15 blue modules. Transcribe notes
taken during the assessment directly into a comment box, so they are not lost. See example below.
4.3.3 Color Coding

As each question is answered, a score between 0% and 100% displays in column G. Scores are color
coded as the following:
• Below 50%: Red
• Between 50 - 79%: Yellow
• 80% or more: Green
Unanswered questions and questions answered “NA” display an apostrophe in column G, indicating no
score. Question scores are automatically averaged together to generate indicator scores, which follow
the same color-coding scheme, and module scores, which are always blue.

5 SCORING SYSTEM
Scoring occurs automatically as questions are answered, and Note: The overall score excludes the
scores display simultaneously on the Module tabs and on the LIS Module score, since the laboratory
Summary tab. Four levels of scores are generated: Questions -> is not directly responsible for
Indicators -> Modules -> Overall. Indicator scores are an deficiencies in the LIS.
average of the question scores comprising that indicator.
Module scores are calculated by averaging all questions in the
module, not by averaging the indicator scores making up the
module. The overall score is calculated by averaging the module
scores.
5.1 Questions
Most questions have three possible answers: Yes, No, or NA (not applicable); some offer partial
responses.
• “Correct” answers score 100%
• “Incorrect” answers score 0%
• Partial responses vary in value: 25%, 50%, 75%
• “NA” and unanswered questions have no value and are excluded from score calculations
5.2 Indicators and Modules

Indicator scores display as percentages. When an indicator displays “NA” instead of a percentage, it
means none of the questions in that section were applicable to the laboratory being assessed. When
an indicator displays “???”, it means the questions within that section were left unanswered. Review
the section and answer the questions if possible. Refer to Figure 5 for examples.
The example in Figure 6, below, shows a portion of the Quality Assurance Module (blue lettering) and
two of the module’s indicators (black background).

The first indicator score is the average of questions 4.1 – 4.11, which is 68% (750/11). The second
indicator score is the average of questions 4.12 – 4.16, which is 100% (400/4). Note that the answer
to question 4.16 is NA, so the question is excluded from the denominator of the calculation. The
module score is not the average of the two indicator scores, which would be 84% (100+68/2). The
module score is the average of all questions, 4.1 – 4.16, excluding NA responses, which is 77%
(1150/15). The rationale for this method of calculation is that it gives equivalent weight to each
question and does not assign greater importance to any indicator.
5.3 Flags
Some questions generate “flags” that appear next to the score. Flags do not impact the score, but
they are useful for prioritizing corrective actions.
• Red Flags represent practices that may put patients or laboratory staff at risk. The laboratory should
correct these items immediately. There are 101 possible red flags
• Training Opportunity Flags highlight areas where sufficient training is commonly lacking. There are
10 possible training opportunities
• System Flags highlight problems for which the solution is often found at the level of the hospital or
national system. Laboratory leadership may need to reach out to hospital, regional, or national
leadership for assistance with correcting these issues. There are 24 possible System Flags

6. RESULTS: SUMMARY, FLAGS, CONCLUSION and PHOTOS

These four tabs summarize the results of the evaluation.
6.1 Summary tab

The Summary tab includes eight parts, four pages when printed:
• Laboratory Identification and Date of Assessment
• Test Menus and Annual Workload data
• Staffing Level
• Module Score Summary and Number of Flags
• Indicator Score Summary
• QC & SOP Scores for Biochemical Identification Reagents
• Equipment Availability Summary
• QMS Mentoring and Laboratory Accreditation Summary
Scores for each Module and Indicator are summarized and displayed in a heat map, shown in Figure 8.
Figure 8: Color coded heat map for the Module: Safety Appendix and its four Indicators
6.2 Flag tab

The Flag tab populates after the questionnaire is completed. This tab will:
• Display all potential flags and the laboratory’s response to each
• Highlight all flags generated
• Show where the flagged questions are located within the tool

6.3 Conclusion tab

The conclusion tab contains an embedded Microsoft Word file where the assessor may summarize
their main findings and recommendations in a narrative format. Embedding the Microsoft Word
document within the Excel file allows the narrative findings and calculated scores to always remain
together in a single file. Double click on the document and a Microsoft Word file will open, which can
be saved or printed. To exit the Word document, click anywhere in the Excel grid.
6.4 Photograph tab

Insert up to six photographs (less than 500KB
Note: Inserting large photos will make the file
each) here, allowing all materials to exist
difficult to share by email.
together in a single file.
Before inserting, resize photos to less than
1. Click on Insert at the top of the page 500KB/2MP (size “Medium”) to keep the final
2. Click Illustrations Excel file small.
3. Click Pictures
4. Select a file from your computer
Always ask permission before photographing anything, particularly individuals. If photographing

laboratory documents, obscure any personally identifying information (PII). Example: covering
patient names with a piece of paper.
7. INTERPRETING RESULTS and DEVELOPING A WORK PLAN

Some general recommendations follow for interpreting the LAARC findings and developing an improvement
plan for the laboratory.
1. Review the data

Review the Summary and Flag tabs in detail with the laboratory staff. Check for errors and make any
necessary corrections before sharing with a wider audience.
2. Develop a work plan
Work plans are at the discretion of the assessor. These are brief suggestions for how to approach a
workplan:
• Develop lists of needed equipment, reagents, supplies, and service contracts
• Prioritize correction of Red Flags, since these highlight practices that may put patients or staff at risk.
If rapid correction is not possible due to lack of funding, the immediate action should be to request
the necessary funding from hospital administrators or others as appropriate.
• Use Training Flags to request specific training for staff

• Use System Flags to request high-level meetings with administrators to discuss remediation
• Review all questions to identify corrections that can be made immediately and/or with very few
resources. This may include developing or updating SOPs, QC forms or job aids, implementing
temperature monitoring
• Review module and indicator scores to prioritize areas for improvement. Note that the areas with the
lowest scores may not be the most urgent for correction
• Develop a timeline for improvements based on resources available and resources needed
3. Summarize findings
Use the Word document in the Conclusions tab to write brief narrative summaries of the findings in
each module, noting both strengths and weaknesses.
4. Explain findings and recommendations
Use a video projector, if possible, to display the results on a large screen or a blank wall. This will enable
more people to attend and view the results.
5. Leave paper and electronic copies of the file with the laboratory
We recommend leaving an electronic copy of the Excel file with relevant members of the laboratory
leadership team so that they can revisit each question as a basis for laboratory improvement. They can
also use it to monitor improvements over time by changing the answers as deficiencies are corrected.
8. EXPORTING DATA
In some cases, it may be useful to compile data from multiple laboratory assessments for comparison
purposes. For example, comparing assessment results from multiple laboratories to one another, or
comparing the results of one laboratory to itself over time. For this purpose, there is an Export tab
embedded in the file. This tab captures all data from the General, Summary and Flag tabs, as well as answers
to select questions from many of the Module tabs. Data from the Export tab may be copied and pasted into
another Microsoft Excel spreadsheet that has been developed for this purpose called the “Reception file.”
Data from the reception file may then be exported into analysis software.
Directions for copying and pasting into the Reception file are as follows:
1. Open both the LAARC Data file and the LAARC Data Reception file.
2. In the LAARC Data file, make sure all questions are answered. Unanswered questions will display as zeros
in the export.
3. Go to the Export tab.
• Select row 6 entirely by clicking on the number “6” at the left edge of the table
• Copy the selected data to the clipboard
• Go to the Export Reception file and select row number 8 entirely by clicking on the number “8” at the
left edge of the table. Row 8 should be blank
• Select “Paste Special,” then click “Values”
• NOTE: A “regular/simple” paste will not allow you to export the data correctly, you must “paste
special” as described above
4. Repeat steps 1-3 for each laboratory using the same Data Reception file. Each additional line of data will
be pasted on the next available blank line: 9, then 10, etc.
5. Once complete, save the Export Reception file

6. Save the file a second time, this time as a .csv (comma separated value)
• Go to “File” select “Save as”
• Keep the same file name, but in “File type,” select “CSV” (Comma Separated value” (*.csv)” in the drop-
down list
7. Save the file
The .csv file can be opened by any database or GIS software. If you have shapefiles of the country or region,
you’ll be able to graphically represent indicators and data on maps. The figure below displays examples of GIS
mapping of equipment and sample volumes from another assessment tool (not LAARC).
Figure 10 : Geographical representation of indicators

9. REFERENCES
1. Clinical & Laboratory Standards Institute (CLSI). Performance Standards for Antimicrobial Susceptibility
Testing. 30th ed. CLSI supplement M100. Clinical & Laboratory Standards Institute, 950 West Valley Road,
Suite 2500, Wayne, Pennsylvania 19087 USA, 2020.
2. College of American Pathologists Laboratory Accreditation Program Checklists. Laboratory General
Checklist and Microbiology Checklist. Northfield, Illinois, College of American Pathologists, 2017.
3. The European Committee on Antimicrobial Susceptibility Testing (https://eucast.org/). Breakpoint tables
for interpretation of MICs and zone diameters. Version 10.0, 2020.
4. ISO 15189:2012. Medical laboratories – Particular requirements for quality and competence.
International Standardization Organization. 2012.
5. Laboratory Assessment Tool. World Health Organization. 2012.
6. Laboratory Checklist. American Society for Microbiology. 2013.

LAARC User’s Guide and Questionnaire Appendix 1: Sample Letter
Appendix 1: Sample Letter
Dear Sir/Madam,
The Ministry of Health of [COUNTRY] is developing a surveillance system for antimicrobial resistance (AR) of
priority bacterial pathogens. [LABORATORY NAME] may serve as a sentinel site for the surveillance system. As
such, an evaluation of the baseline capacity of the laboratory to perform basic bacteriology including isolation,
identification and antibiotic susceptibility testing (AST) has been proposed. The evaluation will be carried out
using the Laboratory Assessment of AR Testing Capacity (LAARC) developed by the International Infection
Control Program at the U.S. Centers for Disease Control and Prevention. The purpose of the evaluation is to
identify gaps in capacity and aid in development of plans for improvement prior to initiating surveillance.
The laboratory assessment may take up to two full days to complete. A proposed schedule is included below:
Day 1 Day 2
8:00 – 8:30 am 7:30 – 9:30 am

• Introductions: Laboratory leadership and • Observe laboratory staff at the bench
other laboratory staff, assessment team • Continue filling assessment
• Review purpose of the evaluation, and 9:30 – 10:00 am
expected timeline • Break for tea
8:30 – 9:30 am 10:00 – Noon
• Tour laboratory • Continue filling assessment
9:30 – 10:00 am Noon – 1:00 pm
• Break for tea • Break for lunch
10:00 – Noon 1:00 – 2:30 pm
• Review pre-assembled documents and • Complete assessment
begin filling questionnaire 2:30 – 3:30 pm
Noon – 1:00 pm • Summation/exit meeting with laboratory
• Break for lunch leadership, other relevant staff
1:00 – 4:30 pm
• Continue filling questionnaire
• Evening – transfer paper responses into
Excel tool
The assessment will be carried out by an experienced clinical bacteriologist, [NAME, TITLE, AND AFFILIATION OF
ASSESSOR if available], a representative from the Ministry of Health, and [ANY ADDITIONAL PERSONNEL].
We will perform the assessment during regular business hours, on days when staffing levels will be adequate to
permit the assessors to interact with the bacteriology technologists without disrupting their workflow. We
request that Bacteriology section heads, supervisors, and quality managers are present during the assessment
and that their schedules are clear of meetings or other obligations to the extent possible.
The following documents and information will require review by the assessors. To the extent these can be
assembled in advance into a single clean room for the team, the time required for the evaluation will be greatly
reduced:
• Names, job titles, and email addresses of relevant bacteriology laboratory leadership (e.g., Director,
Manager, Supervisor, Section Head, Quality Officer, etc.)
• Copies of any recent assessments by a third party
• Annual test volume for each specimen type

• Records of staff qualifications, training and experience
• Accreditation and/or Certification documents
• Equipment inventory
• Equipment calibration and maintenance records
• Contingency plans in the event of an emergency or extended downtime
• Specimen requisition form
• Bacteriology logbooks or Laboratory Information System records
• Standard form used for reporting ID/AST results to clinicians
• Quality Manual
• Records of the last three AST EQA/PT performance results, and associated discrepancy
investigations
• Quality Control records for temperatures, media, reagents, and AST
• Specimen collection guidelines or SOPs
• SOPs for specimen processing, reagents, ID and AST test systems
• Copies of any recent safety audits
• Reserve a room with a video projector, if possible, for the final summation meeting
All findings and recommendations shall be discussed with the bacteriology supervisor in private prior to the final
summation. Please reach out to [Assessment Team Lead] with any questions.
The following dates have been proposed [dd/mm/yyyy – dd/mm/yyyy]. Please contact [Ministry Official] to
accept or reschedule your assessment dates.
Sincerely,
[Assessment Team Lead]

LAARC User’s Guide and Questionnaire Appendix 2: Recommended Resources
Appendix 2: Recommended Resources
The following documents are useful resources for clinical bacteriology laboratories. Many are free, others may
be obtained for a fee.
Culture and Identification

• CLSI M35: Abbreviated Identification of Bacteria and Yeast
• CLSI M47: Principles and Procedures for Blood Cultures
• CLSI M54: Principles and Procedures for Detection of Fungi in Clinical Specimens-Direct Examination and
Culture
• CLSI M56: Principles and Procedures for Detection of Anaerobes in Clinical Specimens
• CLSI M58: Methods for the ID of Cultured Microorganisms using MALDI-TOF Mass Spectrometry
AST/AMR
• CLSI M02: Performance Standards for Antimicrobial Disk Susceptibility Tests
• CLSI M02QG: Disk Diffusion Reading Guide
• CLSI M07: Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria That Grow Aerobically
• CLSI M39: Analysis and Presentation of Cumulative Antimicrobial Susceptibility Test Data
• CLSI M45: Methods for Antimicrobial Dilution and Disk Susceptibility Testing of Infrequently Isolated or
Fastidious Bacteria
• CLSI M100 Performance Standards for Antimicrobial Susceptibility Testing
• ETEST Reading Guide [PDF - 2 pages] (http://www.ilexmedical.com/files/ETEST_RG.pdf)
• EUCAST Breakpoint Tables
• EUCAST Disk Test Reading Guide
• EUCAST reading guide for broth microdilution
• EUCAST Manual Disk Test
• EUCAST Preparation of agar plates and broth for EUCAST AST
• EUCAST Intrinsic Resistance and Unusual Phenotypes
• EUCAST Expert Rules for Enterobacterales, Staphylococcus, and other species
(http://www.eucast.org/expert_rules_and_intrinsic_resistance/)
• EUCAST guidelines for detection of resistance mechanisms and specific resistances of clinical and/or
epidemiological importance
Quality Control
• CLSI M22: Quality Control for Commercially Prepared Microbiological Culture Media
• CLSI M40: Quality Control of Microbiological Transport Systems
• CLSI M50: Quality Control for Commercial Microbial Identification Systems
• CLSI M52: Verification of Commercial Microbial ID and AST Systems
• EUCAST QC tables
Laboratory Quality Management Systems (QMS)

• WHO Laboratory Quality Stepwise Implementation Tool
• CLSI QMS01: A QMS Model for Laboratory Services
• CLSI QMS01CL: Gap Analysis Checklists
• CLSI QMS02: QMS: Development and Management of Laboratory Documents
• CLSI QMS03: Training and Competence Assessment
• CLSI QMS04: Laboratory Design
• CLSI QMS05: QMS: Qualifying, Selecting and Evaluating a Referral Laboratory
• CLSI QMS06: QMS: Continual Improvement
• CLSI QMS11: Nonconforming Event Management
• CLSI QMS12: Developing and Using Quality Indicators for Laboratory Improvement
• CLSI QMS13: QMS: Equipment
• CLSI QMS14: QMS: Leadership and Management Roles and Responsibilities
• CLSI QMS15: Assessments: Laboratory Internal Audit Program
• CLSI QMS16: Laboratory Personnel Management
• CLSI QMS17: External Assessments, Audits, and Inspections of the Laboratory
• CLSI QMS18: Process Management
• CLSI QMS20: Understanding the Cost of Quality in the Laboratory
• CLSI QMS21: Purchasing and Inventory Management
• CLSI QMS22: Management of Paper-Based and Electronic Laboratory Information
• CLSI QMS23: General Laboratory Equipment Performance Qualification, Use, and Maintenance
• CLSI QMS24: Using Proficiency Testing and Alternative Assessment to Improve Medical Laboratory
Quality
• CLSI QMS25: Handbook for Developing a Laboratory Quality Manual
Laboratory Biosafety
• WHO Laboratory Biosafety Manual
(https://www.who.int/csr/resources/publications/biosafety/WHO_CDS_CSR_LYO_2004_11/en/)
• CLSI M29: Protection of Laboratory Workers from Occupationally Acquired Infections
• CLSI GP05: Clinical Laboratory Waste Management
• CLSI GP17: Clinical Laboratory Safety
• CDC Biosafety in Microbiological and Biomedical Laboratories (BMBL)
(https://www.cdc.gov/labs/BMBL.html)

LAARC User’s Guide and Questionnaire Appendix 3: LAARC Questionnaire
Appendix 3: LAARC Questionnaire
Table of Contents
Introduction ............................................................................................................................................................32
Assessor's Guide ......................................................................................................................................................33
0- GENERAL INFORMATION ......................................................................................................................................36
LABORATORY DEMOGRAPHICS ......................................................................................................................................... 36
TEST MENU and WORKLOAD ............................................................................................................................................ 37
AST/AMR METHODS AND WORKLOAD ............................................................................................................................. 38
LABORATORY STAFF EDUCATION/TRAINING .................................................................................................................... 38
QMS MENTORING PROGRAMS ......................................................................................................................................... 39
ACCREDITATION and CERTIFICATION ............................................................................................................................... 39
1- FACILITY...............................................................................................................................................................40
LABORATORY FACILITY ...................................................................................................................................................... 40
GENERAL EQUIPMENT AVAILABILITY ................................................................................................................................ 40
MEDIA PREPARATION EQUIPMENT AVAILABILITY ............................................................................................................ 41
EQUIPMENT CALIBRATION RECORDS ............................................................................................................................... 41
THERMOMETERS............................................................................................................................................................... 41
TEMPERATURE AND ATMOSPHERE MONITORING ........................................................................................................... 42
AUTOCLAVE MANAGEMENT ............................................................................................................................................. 43
INSTRUMENT AVAILABILITY AND MAINTENANCE ............................................................................................................ 43
INVENTORY & STOCK OUTS .............................................................................................................................................. 44
2 - LABORATORY INFORMATION SYSTEM (ELECTRONIC)............................................................................................46
DEMOGRAPHIC DATA FIELDS ............................................................................................................................................ 46
SPECIMEN DATA FIELDS .................................................................................................................................................... 46
CULTURE OBSERVATION DATA FIELDS.............................................................................................................................. 46
AST DATA FIELDS ............................................................................................................................................................... 47
REPORTS AND DATA TRANSFER CAPABILITIES.................................................................................................................. 47
INTERFACE CONNECTIVITY................................................................................................................................................ 47
3- DATA MANAGEMENT ...........................................................................................................................................49
PATIENT AND SPECIMEN IDENTIFICATION ....................................................................................................................... 49
SPECIMEN REQUISITION FORM ........................................................................................................................................ 49
ORDER ENTRY.................................................................................................................................................................... 49
CULTURE OBSERVATIONS ................................................................................................................................................. 50
AST RESULTS REPORTING.................................................................................................................................................. 50
DATA BACKUP & SECURITY ............................................................................................................................................... 51
AMR DATA SHARING ......................................................................................................................................................... 51

4- QUALITY ASSURANCE ...........................................................................................................................................52
QUALITY STRUCTURE/BASICS ........................................................................................................................................... 52
LABORATORY STAFF EDUCATION/TRAINING/COMPETENCY............................................................................................ 52
TOUBLESHOOTING, PROBLEM SOLVING, AND ROOT CAUSE ANALYSES .......................................................................... 53
EXTERNAL QUALITY ASSESSMENT (EQA) .......................................................................................................................... 53
5- MEDIA PREPARATION AND QUALITY CONTROL .....................................................................................................55
MEDIA PREPARATION SOPs .............................................................................................................................................. 55
GENERAL MEDIA PREPARATION ....................................................................................................................................... 55
DISTILLED/DEIONIZED WATER PREPARATION .................................................................................................................. 55
ROUTINE MEDIA QC .......................................................................................................................................................... 55
MULLER HINTON MEDIA PREPARATION AND QC ............................................................................................................. 56
BLOOD CULTURE BOTTLES PREPARATION AND QC .......................................................................................................... 57
6- QUALITY CONTROL - ID METHODS ........................................................................................................................58
GRAM STAIN QC and REAGENT LABELING AND STORAGE ............................................................................................... 58
QC OF INDIVIDUAL BIOCHEMICAL METHODS ................................................................................................................... 58
QC OF ENTERIC SEROLOGY ............................................................................................................................................... 61
QC OF COMMERCIAL ID KITS and AUTOMATED ID SYSTEMS ........................................................................................... 61
7- QUALITY CONTROL - AST METHODS ......................................................................................................................62
ROUTINE AST REFERENCE STRAINS................................................................................................................................... 62
SPECIAL AST REFERENCE STRAINS .................................................................................................................................... 62
QC OF DISC DIFFUSION AST METHODS ............................................................................................................................. 63
QC OF GRADIENT STRIP AST METHODS ............................................................................................................................ 63
QC OF AUTOMATED AST SYSTEMS ................................................................................................................................... 64
8- SPECIMEN COLLECTION, TRANSPORT & MANAGEMENT ........................................................................................65
SPECIMEN MANAGEMENT ................................................................................................................................................ 65
SPECIMEN REJECTION ....................................................................................................................................................... 65
BLOOD SPECIMEN COLLECTION and TRANSPORT ............................................................................................................ 65
URINE SPECIMEN COLLECTION and TRANSPORT.............................................................................................................. 66
STOOL SPECIMEN COLLECTION and TRANSPORT ............................................................................................................. 66
9- PROCESSING ........................................................................................................................................................67
BLOOD CULTURE PROCESSING ......................................................................................................................................... 67
MANUAL BLOOD CULTURE SYSTEMS................................................................................................................................ 67
URINE CULTURE ................................................................................................................................................................ 67
STOOL CULTURES for Salmonella and Shigella ................................................................................................................. 68
10- IDENTIFICATION METHODS & STANDARD OPERATING PROCEDURES ...................................................................69
CONVENTIONAL ID METHODS .......................................................................................................................................... 69
STAPHYLOCOCCUS AUREUS, KEY ID METHODS ................................................................................................................ 69

STAPHYLOCOCCUS AUREUS, OTHER ID METHODS ........................................................................................................... 70
STREPTOCOCCUS PNEUMONIAE, CONVENTIONAL ID METHODS ..................................................................................... 70
ENTEROBACTERIACEAE, CONVENTIONAL ID METHODS ................................................................................................... 71
SHIGELLA/SALMONELLA SEROLOGY ................................................................................................................................. 73
ACINETOBACTER SPP, CONVENTIONAL ID METHODS ...................................................................................................... 73
KIT-BASED ID METHODS.................................................................................................................................................... 74
AUTOMATED ID METHODS ............................................................................................................................................... 75
IDENTIFICATION FLOWCHARTS ......................................................................................................................................... 75
11- ANTIMICROBIAL SUSCEPTIBILITY TESTING (AST) BASICS ......................................................................................77
ANTIBIOTIC DISK AND GRADIENT STRIPS MAINTENANCE ................................................................................................ 77
INOCULUM PREPARATION ................................................................................................................................................ 77
INOCULATION/INCUBATION ............................................................................................................................................. 78
READING AST RESULTS ...................................................................................................................................................... 78
INTERPRETING RESULTS .................................................................................................................................................... 79
BREAKPOINTS STANDARDS ............................................................................................................................................... 80
12- AST EXPERT RULES .............................................................................................................................................81
EXPERT RULES FOR SALMONELLA ..................................................................................................................................... 81
GRAM NEGATIVES & BETA-LACTAM BREAKPOINTS ......................................................................................................... 81
PHENOTYPIC ESBL TESTING............................................................................................................................................... 82
PHENOTYPIC CARBAPENEMASE TESTING ......................................................................................................................... 82
COLISTIN TESTING ............................................................................................................................................................. 83
EXPERT RULES FOR STAPHYLOCOCCUS AUREUS............................................................................................................... 84
GENERAL CONSIDERATIONS FOR STREPTOCOCCUS PNEUMONIAE ................................................................................. 84
EXPERT RULES FOR STREPTOCOCCUS PNEUMONIAE ....................................................................................................... 84
INDUCIBLE CLINDAMYCIN RESISTANCE TESTING .............................................................................................................. 85
EXPERT RULES FOR CEREBROSPINAL FLUID (CSF) ............................................................................................................. 85
13- AST PANELS, POLICY & ANALYSIS ........................................................................................................................86
AST PANELS ....................................................................................................................................................................... 86
CUMULATIVE ANTIBIOGRAMS .......................................................................................................................................... 86
AST POLICY ........................................................................................................................................................................ 86
SAFETY ....................................................................................................................................................................88
BIOSAFETY EQUIPMENT .................................................................................................................................................... 88
PERSONAL PROTECTIVE EQUIPMENT ............................................................................................................................... 88
BIOSAFETY BEHAVIORS ..................................................................................................................................................... 89
BIOSAFETY DOCUMENTATION AND TRAINING ................................................................................................................. 89

Introduction
Control of antibiotic resistance (AR) is a global public health priority. Robust AR laboratory networks are critical to inform policy and
control efforts. Such networks often obtain AR data from clinical laboratories; thus, the usefulness of the aggregate data largely
depends on the ability of the laboratories to produce accurate and reliable bacterial identification (ID) and antibiotic susceptibility
testing (AST) results.
Many existing laboratory assessment tools are designed to evaluate the essential quality management system (QMS) requirements
described by international laboratory standards organizations such as ISO and CLSI. These tools are inadequate to detect deficiencies
in bench-level testing because they lack sufficient technical depth and granularity. The LAARC assessment tool is designed to fill that
technical gap and is specifically adapted for laboratories in low- and middle- income countries which have not yet established
comprehensive laboratory regulations and/or accreditation requirements. The tool contains extensive Quality Control (QC) and
Quality Assurance (QA) questions, but it is primarily technical in nature and does not provide a comprehensive QMS assessment.
The purpose of the LAARC is to objectively evaluate technical proficiency in the bacteriologic techniques and related quality
processes that are required for accurate, reliable AR detection. Results provide a clear pathway toward improvement. The LAARC
was designed for use in hospital-based laboratories that receive and process clinical specimens for the purposes of routine patient
care. National reference laboratories (NRLs) and other public health labs will benefit from the technical assessment, however, the
key gaps in assessing NRL capacity include the lack of questions about molecular testing, funding and budget, the non-laboratory
personnel required to administer an AMR surveillance program and much more. Other tools are available to assess these areas.
The LAARC was built around the WHO priority AR specimen types, pathogens and antibiotics included in their Global Antimicrobial
Resistance Surveillance System (GLASS) initiative of 2015. These are:
• Staphylococcus aureus Blood

• Streptococcus pneumoniae Blood
• Escherichia coli Blood & Urine
• Klebsiella pneumoniae Blood & Urine
• Salmonella species Stool/Feces
• Shigella species Stool/Feces
• Acinetobacter baumannii * Blood
• Neisseria gonorrhoeae † Urethral & cervical swabs
Additional culture types, pathogens and antibiotics may be evaluated pursuant to national priorities; however, the current iteration
of this tool focuses only on the above; users cannot edit or modify the tool.
* Most labs are unable to definitively differentiate Acinetobacter calcoaceticus from A. baumannii, so in practice this
refers to Acinetobacter calcoaceticus-baumannii complex.
† N. gonorrhoeae was excluded from this tool due to the complexities involved with routine culture and recovery,
identification and AST, and the existence of other surveillance networks and STD clinics dedicated exclusively to this
pathogen.
Assessor's Guide
Figure for use with Facility Module, question 1.13
McFarland QC Standards in front of a Wickerham card
Figure 2 for use with AST QC Module, questions 7.7 - 7.11

Workflow for subculturing and using Figure 2: Proper maintenance of ATTC stock cultures
reference strains as described in CLSI ©Clinical and Laboratory Standards Institute. All rights reserved.
M02, Subchapter 4.4
Figure 2 Abbreviations:
"F" indicates the frozen or freeze-

dried state of the stock culture
"1" indicates the first passage
"2" indicates the second passage
"3" indicates the third passage from

stock culture
“QC” indicates Quality Control
Maintenance of ATCC strains begins

with a subculture from the frozen or
lyophilized stock to the F1 plate. The F1
plate is then stored for one month.
On day 1, F1 is subcultured to the F2
plate. The F2 plate is stored and used
for one week. Each day that a fresh
isolate is required, a subculture is made
from the F2 plate to an F3 plate. F3
plates are discarded after each use.
After one week of storage, the F2 plate
is discarded and a new F2 plate is
subcultured from the F1 plate. This
process repeats for four weeks. After
four weeks, the F1 plate is discarded
and a fresh F1 plate is subcultured from
the frozen or lyophilized stock.
Tables for use with AST Expert Rules Module, questions 12.7 - 12.25
Current CLSI and EUCAST breakpoints for Salmonella spp, Enterobacteriaceae, Acinetobacter spp, and Pseudomonas
aeruginosa
S-DD = Susceptible, but dose-dependent
CLSI 2020 breakpoints for Salmonella spp

MIC method MIC method MIC method Disk Diffusion Disk Diffusion Disk Diffusion
Salmonella spp. Disk µg S I R S I R
Ciprofloxacin 5 ≤0.06 0.12-0.5 ≥1 ≥31 21-30 ≤20
Levofloxacin - ≤0.12 0.25-1 ≥2 - - -
Pefloxacin
5 - - -
≥24 - ≤23
screen
EUCAST 2020 breakpoints for Salmonella spp

MIC method MIC method Disk Diffusion Disk Diffusion
Salmonella spp. Disk µg S R S R
Ciprofloxacin - ≤0.06 >0.06 - -
Levofloxacin - - - - -
Pefloxacin
5 - - ≥24 <24
screen
CLSI 2020 breakpoints for Enterobacterales

MIC method MIC method MIC method Disk Diffusion Disk Diffusion Disk Diffusion
Enterobacterales Disk µg S I / S-DD R S I / S-DD R
Aztreonam 30 ≤4 8 ≥16 ≥21 18-20 ≤17
Cefotaxime 30 ≤1 2 ≥4 ≥26 23-25 ≤22
Ceftriaxone 30 ≤1 2 ≥4 ≥23 20-22 ≤19
Ceftazidime 30 ≤4 8 ≥16 ≥21 18-20 ≤17
Cefepime 30 ≤2 4-8 (S-DD) ≥16 ≥25 19-24 (S-DD) ≤18
Imipenem 10 ≤1 2 ≥4 ≥23 20-22 ≤19
Meropenem 10 ≤1 2 ≥4 ≥23 20-22 ≤19
Doripenem 10 ≤1 2 ≥4 ≥23 20-22 ≤19
Ertapenem 10 ≤0.5 1 ≥2 ≥22 19-21 ≤18
EUCAST 2020 breakpoints for Enterobacterales

MIC method MIC method Disk Diffusion Disk Diffusion
Enterobacterales Disk µg S R S R
Aztreonam 30 ≤1 >4 ≥26 <21
Cefotaxime 5 ≤1 >2 ≥20 <17
Ceftriaxone 30 ≤1 >2 ≥25 <22
Ceftazidime 10 ≤1 >4 ≥22 <19
Cefepime 30 ≤1 >4 ≥27 <24
Imipenem 10 ≤2 >4 ≥22 <17
Meropenem 10 ≤2 >8 ≥22 <16
Doripenem - - - - -
Ertapenem 10 ≤0.5 >0.5 ≥25 <25
CLSI 2020 breakpoints for Acinetobacter spp.

Acinetobacter MIC method MIC method MIC method Disk Diffusion Disk Diffusion Disk Diffusion
spp. Disk µg S I R S I R
Imipenem 10 ≤2 4 ≥8 ≥22 19-21 ≤18
Meropenem 10 ≤2 4 ≥8 ≥18 15-17 ≤14
Doripenem 10 ≤2 4 ≥8 ≥18 15-17 ≤14

EUCAST 2020 breakpoints for Acinetobacter spp.
Acinetobacter MIC method MIC method Disk Diffusion Disk Diffusion
spp. Disk µg S R S R
Imipenem 10 ≤2 >4 ≥24 <21
Meropenem 10 ≤2 >8 ≥21 <15
Doripenem - - - - -
CLSI 2020 breakpoints for Pseudomonas aeruginosa

Pseudomonas MIC method MIC method MIC method Disk Diffusion Disk Diffusion Disk Diffusion
aeruginosa Disk µg S I R S I R
Aztreonam 30 ≤8 16 ≥32 ≥22 16-21 ≤15
Piperacillin 100 ≤16 32-64 ≥128 ≥21 15-20 ≤14
Piperacillin-
100/10 ≤16 32-64 ≥128 ≥21 15-20 ≤14
Tazobactam
Cefepime 30 <8 16 >32 >18 15-17 <14
Imipenem 10 <2 4 >8 >19 16-18 <15
Meropenem 10 <2 4 >8 >19 16-18 <15
Doripenem 10 <2 4 >8 >19 16-18 <15
EUCAST 2019 breakpoints for Pseudomonas aeruginosa

Pseudomonas MIC method MIC method Disk Diffusion Disk Diffusion
aeruginosa Disk µg S R S R
Aztreonam 30 ≤16 >16 ≥18 <18
Piperacillin 30 ≤16 >16 ≥18 <18
Piperacillin-
30/6 ≤16 >16 ≥18 <18
Tazobactam
Ticarcillin-
75/10 ≤16 >16 ≥18 <18
Clavulanate
Cefepime 30 ≤8 >8 ≥21 <21
Imipenem 10 ≤4 >4 ≥20 <20
Meropenem 10 ≤2 >8 ≥24 <18
Doripenem - - - - -

0- GENERAL INFORMATION
LABORATORY DEMOGRAPHICS
Question Number
Question Answer
0.1 Assessor 1 (last name and affiliation)
Enter answer

Enter answer

Enter answer
0.4 Date of assessment (dd/mm/yyyy)

Enter answer
0.5 Laboratory/Hospital name

Enter answer
0.6 Address
Enter answer
0.7 City
Enter answer
0.8 Province
Enter answer
0.9 District
Enter answer
0.10 Country
Enter answer
GPS position of the laboratory (used for GIS representation of indicators). PLEASE ONLY USE DIGITAL DEGREE WITH + OR - SIGN. DO
NOT USE DEGREES, MINUTES, SECONDS GPS position of the laboratory (used for GIS representation of indicators). PLEASE ONLY USE
DIGITAL DEGREE WITH + OR - SIGN. DO NOT USE DEGREES, MINUTES, SECONDS
Question Number
Question Answer Example
For altitude, enter meters without digits. Example: If altitude is 61.49 meters,
Enter answer
0.11
Altitude enter 61
For latitude, enter digital degrees with 5 digits after the comma. Example: 41,40338
Enter answer
0.12
Latitude
For longitude, enter digital degrees with 5 digits after the comma. Example: -2,17403
Enter answer
0.13
Longitude
0.14 Contact information of the relevant bacteriology laboratory leadership; e.g., Director, Manager, Supervisor, Section Head,
Quality Officer
Title/Position First Name Last name Email address
Enter answer Enter answer Enter answer Enter answer
Question Answer Comments

Question Number
Primary Laboratory/Facility funding sources

1. Public/Government
0.15 2. Private 1234 place holder
3. NGO/Faith-based/Donors
4. Other
Primary Laboratory affiliation
1. Hospital: University Medical Center or Teaching Hospital
2. Hospital: Military
3. Hospital: (not academic or military)
1234
0.16 4. Clinic (primarily outpatient) place holder
567
5. Reference/referral lab within a Public Health Institute
6. Reference/referral lab not affiliated with a single healthcare facility or
public health institute
7. Other, e.g., Research Laboratory

Question Number
Laboratory/Facility Level (if primarily government funded)

1. National
2. Regional 123
0.17 place holder
3. Provincial 45
4. District
5. NA
Service level of the Hospital/Healthcare Facility
1. Primary
2. Secondary 123
0.18 place holder
3. Tertiary 45
4. Other
5. NA
Number of beds of the Hospital/Healthcare Facility
1: <100
2: 100 - 499 123
0.19 place holder
3: 500 - 1000 45
4: >1000
5: NA
TEST MENU and WORKLOAD

Please note: all questions refer only to clinical patient specimens, NOT #
to environmental or research specimens cultures
Question Number Does the lab perform the following types of culture? Answer last year Comment
Instructions for
the 3 items
In the # cultures last year column, please enter the total number of place holder place holder place holder
below.
cultures performed last year, both positive and negative
0.20 Blood Cultures Y N
Enter number Enter comment
0.21 Urine Cultures Y N

0.22 Stool Cultures (all bacterial enteric pathogens) Y N

Instructions for
the 5 items
Please indicate if the lab performs stool culture for the following place holder place holder place holder
below.
enteric pathogens. Do not enter the number of cultures.
0.23 Salmonella and/or Shigella Y N place holder place holder
0.24 Vibrio cholerae Y N place holder place holder
0.25 Yersinia enterocolitica Y N place holder place holder
0.26 Campylobacter jejuni Y N place holder place holder
0.27 Enterohemorrhagic/Enterotoxic E. coli (e.g., O157:H7) Y N place holder place holder
0.28 Respiratory Cultures (not TB/AFB) Y N

0.29 Wound Cultures Y N

0.30 Cerebrospinal Fluid Cultures Y N

0.31 Sterile Body Fluid Cultures (pleural, pericardial, peritoneal, synovial) Y N

0.32 Genital Cultures Y N

0.33 Anaerobic Cultures Y N

0.34 Fungal Cultures (Yeast) Y N

0.35 Fungal Cultures (Mold) Y N

0.36 MRSA screen for Infection Control purposes (e.g., nares, axilla, groin) Y N
0.37 VRE screen for Infection Control purposes (e.g., rectal swab) Y N
0.38 CRE screen (e.g., rectal swab) Y N

0.39 Identification and/or AST of isolates referred from other laboratories Y N

Other cultures of local importance (opportunity to customize via

0.40 Y N
comments)

AST/AMR METHODS AND WORKLOAD
# organisms
Question Number
Question Answer last year Comment

Which manual AST methods are in use?
Instructions for In the # organisms last year column, please enter the approximate place holder place holder place holder
number of organisms tested using each method, not the number of

questions below
antibiotics tested
0.41 Disk diffusion Y N
0.42 Gradient Strip (e.g., Etest/Liofilchem) Y N

0.43 Broth microdilution (96-well tray) Y N

0.44 Broth macrodilultion (tube method) Y N

0.45 Agar dilution Y N

Which automated AST methods are in use?

Question and
instructions for
In the # organisms last year column, please enter the approximate place holder place holder place holder
the items below.
number of organisms tested using each method, not the number of
antibiotics tested
0.46 Vitek Y N
0.47 Phoenix Y N
0.48 Microscan Y N
0.49 Other, please specify in comments. Y N

Does the lab use chromagar to detect antibiotic resistant

Question and
instructions for
organisms? place holder place holder place holder
the items below.
In the # organisms last year column, please enter the approximate
number of organisms tested using each method
0.50 ESBL producers Y N
0.51 CRE/Carbapenemases Y N
0.52 MRSA Y N
0.53 VRE Y N
0.54 Colistin resistance Y N


Does the lab use PCR to detect antibiotic resistance genes?

Question and
instructions for
the items below.
In the # organisms last year column, please enter the approximate place holder place holder place holder
number of organisms tested using each method

0.56 ESBLs Y N
0.57 Carbapenemases Y N
0.58 mecA Y N
0.59 vanA/vanB Y N
0.60 mcr-1 Y N

LABORATORY STAFF EDUCATION/TRAINING

Question Number
Among laboratory leadership and the technical staff in bacteriology,
indicate the number that fall into each training level category. Answer # staff Comment
Advanced degree in Medical Microbiology or Medical Laboratory
0.62 Y N
Sciences (PhD, MD, equivalent)
0.63 Advanced degree, other concentration (PhD, MD, equivalent) Y N
Postgraduate Master's degree in Microbiology or Medical Laboratory

0.64 Y N
Sciences
0.65 Postgraduate Master's degree, other concentration Y N
Graduate Bachelor's degree in Microbiology or Medical Laboratory

0.66 Y N
Sciences
0.67 Graduate Bachelor's degree, other concentration Y N
Undergraduate Certificate or Diploma in Microbiology or Medical

0.68 Y N
Laboratory Sciences

Question Number
Among laboratory leadership and the technical staff in bacteriology,
indicate the number that fall into each training level category. Answer # staff Comment
0.69 Undergraduate Certificate or Diploma, other concentration Y N
0.70 High school/Secondary school diploma Y N

0.71 On-the-job training only Y N

0.72 Other (specify in comments) Y N

QMS MENTORING PROGRAMS

Question Number
Question Answer Year Comment
0.73 Has the laboratory ever been enrolled in the SLIPTA program? Y N
Enter year Enter comment
If yes, when was the most recent certification awarded?

1: Within the past 2 years 1 2

0.74
2: More than 2 years ago NA
3: NA
If yes, what is the star level of the latest SLIPTA audit? Check the
certificate. 0 1 2
0: 0 stars 4: 4 stars 3
0.75 place holder place holder
1: 1 star 5: 5 stars 4 5
2: 2 stars NA NA
3: 3 stars
Has the laboratory ever been enrolled in the WHO LQSI program?
0.76 Y N
What year?
If yes, what was the last overall % score for the 4 phases? What year?
1: >90% 4: <50% 1 2 3
0.77
2: 70%-89% NA 4 NA
3: 50-69%
Has the laboratory ever been enrolled in any other mentoring
0.78 program for Laboratory Quality Management (National, Regional, Y N

International)? When?
ACCREDITATION and CERTIFICATION

Does the lab possess a valid (current) ISO 15189 accreditation
Question Number
certificate for any of the following tests? (Confirm by reviewing Year
certificate) Answer awarded Comment
0.79 Blood cultures Y N
0.80 Stool cultures Y N

0.81 Urine cultures Y N

0.82 Organism Identification Y N

0.83 Antibiotic Susceptibility Testing Y N

0.84 Any other microbiology applied technique such as Gram staining? Y N

Who awarded the most recent accreditation? (Review accreditation 1

Enter comment
certificate and write name of accrediting body in comments) 2

(ILAC = International Laboratory Accreditation Cooperation) 3
1: ILAC Full Member 4
2: ILAC Associate Member 5
3: ILAC Affiliate Member 6
0.85 4: ILAC Stakeholder 7 place holder
5: ILAC Regional Cooperation Body NA

6: Other/Don't know
7: National Accrediting Board
NA
ILAC MRA Signatory Search (https://ilac.org/signatory-
search/#elementid)

1- FACILITY
Please note: all questions refer to equipment that is used for clinical patient specimens, NOT equipment that is used only for
research specimens
LABORATORY FACILITY
Question Number
Question Answer Comment
Topic for
questions below. Observe the laboratory work benches, are they: place holder place holder
1.1 Separate from patient care areas Y N

Enter comment
1.2 Organized with minimal clutter? Y N

Enter comment
1.3 Adequately ventilated? Y N

Enter comment
1.4 Free of excess moisture? Y N

Enter comment
1.5 Adequately lit? Y N

Enter comment
1.6 Does the laboratory have a functional heating/air conditioning system? Y N

Enter comment
1.7 Is the temperature in the laboratory maintained between 20°-25°C? Y N

Enter comment
Are all critical equipment (instruments, refrigerators, freezers, incubators, YN

Enter comment
1.8
computers, automated instruments) supported by a functioning generator? Partial
Are all critical pieces of equipment attached to uninterrupted power source
Enter comment
YN
1.9 (UPS) devices? (These provide temporary power until the generator can be
Partial
activated)
In the last 6 months, has prolonged power failure disrupted the ability to
Enter comment
1.10 Y N
provide routine bacteriology services?
Is there a contingency plan in place for continued testing in the event of
Enter comment
1.11 Y N
prolonged electricity disruption (e.g., power outage lasting several days)?
Standard: ISO 15189: 5.2.5 & 5.2.10 The laboratory space should be sufficient to
ensure that the quality of work, the safety of personnel, and the ability of staff to
carry out quality control procedures and documentation. The laboratory should
be clean and well organized, free of clutter, well-ventilated, adequately lit, and
Standard for item
above. within acceptable temperature ranges. Emergency power should be available for place holder place holder
sensitive instruments, temperature-controlled storage, and other essential

equipment to prevent damage and disruption due to unexpected power
fluctuations and outages. Sensitive instruments should be equipped with surge
controls. Distilled and de-ionized water should be available, if required.
Describe the internet service in the laboratory
Enter comment
1: Continuous (service interruptions are rare)

1.12 123
2: Sporadic (service interruptions are common)
3: No internet available
GENERAL EQUIPMENT AVAILABILITY

Question Number Question Functional? (#) Comment
Indicate whether the lab has the following FUNCTIONAL equipment.
In column D (#), indicate how many pieces of FUNCTIONAL equipment
Instructions for are present. If the lab only has non-functional equipment, select "No" place holder
place
place holder
and write "non-functional" in the comments. Also indicate in the

items below. holder
comments if the quantity of equipment is sufficient for the laboratory's

volume of testing.
1.13 McFarland QC standards of known densities, including 0.5, not expired Y N
Enter Enter comment
number
1.14 Ruler or caliper with millimeter markings Y N

Enter Enter comment
number
1.15 Bunsen burners or micro-incinerators Y N

Enter Enter comment
number
1.16 Calibrated 1uL or 10uL loops (for plating urine cultures) Y N place Enter comment
holder
Optical densitometer/turbidimeter (for determining McFarland

Enter Enter comment
number
1.17 Y N
density)
1.18 Microliter pipettes (e.g., Eppendorf) Y N
Enter Enter comment
number
1.19 Centrifuge (not used for TB cultures) Y N

Enter Enter comment
number
1.20 Microscope Y N
Enter Enter comment
number
1.21 Thermometers Y N
Enter Enter comment
number

Question Number Question Functional? (#) Comment
1.22 CO2 incubators Y N
Enter Enter comment
number
1.23 Candle jars Y N

Enter Enter comment
number
1.24 Ambient (non-CO2) incubator Y N

Enter Enter comment
number
1.25 Refrigerator (2-8°C) Y N

Enter Enter comment
number
1.26 Non-defrosting freezer, -20°C Y N

Enter Enter comment
number

Enter Enter comment
number

Enter Enter comment
number
Rechargeable desiccants (for storage of open antibiotic disks and

1.29 Y N Placehol
Enter comment
strips)
der
1.30 Hot air oven (for drying saturated desiccants) Y N

Enter Enter comment
number
1.31 Biological Safety Cabinet Class IIA Y N

Enter Enter comment
number
1.32 Autoclave for media preparation ("clean" autoclave) Y N

Enter Enter comment
number
1.33 Autoclave for sterilizing waste ("dirty" autoclave) Y N

Enter Enter comment
number
MEDIA PREPARATION EQUIPMENT AVAILABILITY

Question Number
Does the laboratory prepare any media or distilled water? (e.g., blood agar,
1.34 Mueller Hinton agar, blood culture bottles) Y N Enter comment
If No, answer NA until next section

Media Preparation Equipment Type
Indicate whether the lab is currently using the following FUNCTIONAL

equipment. If the lab has only non-functional equipment, select "No"
Question Number and note "non-functional" in the comments. Functional? (#) Comment
1.35 pH meter Y N NA
Enter Enter comment
number
1.36 Weighing balance Y N NA

Enter Enter comment
number
1.37 Conductivity meter Y N NA

Enter Enter comment
number
1.38 Distiller / reverse osmosis equipment Y N NA

Enter Enter comment
number
1.39 Hot plate with magnetic stir bar (for mixing powdered media) Y N NA
Enter Enter comment
number
1.40 Water bath Y N NA

Enter Enter comment
number
EQUIPMENT CALIBRATION RECORDS

Review the calibration records for each piece of equipment. Has calibration
been performed within the last year?
Question Number (Select NA only if the lab does not have the equipment.) Answer Comment
1.41 Optical Densitometer (for determining McFarland density) Y N NA
Enter comment
1.42 Microliter pipettes (e.g., Eppendorf) Y N NA

Enter comment
1.43 Centrifuge Y N NA
Enter comment
1.44 Thermometers Y N NA
Enter comment
1.45 pH meter Y N NA
Enter comment
1.46 Conductivity meter Y N NA

Enter comment
1.47 CO2 incubator Y N NA

Enter comment
1.48 Ambient (non-CO2) incubator Y N NA

Enter comment
1.49 Hot air oven for recharging desiccants Y N NA

Enter comment
1.50 Biological Safety Cabinet Class IIA Y N NA

Enter comment
1.51 Weighing balance Y N NA

Enter comment

Enter comment
THERMOMETERS
Indicate if manual (non-digital) thermometers are present inside each piece
Question Number of equipment. (Select NA if the lab does not have the equipment.) Answer Comment
1.53 CO2incubator Y N NA
Enter comment
1.54 Ambient (non-CO2) incubator Y N NA

Enter comment
1.55 Refrigerator (2-8°C) Y N NA

Enter comment
1.56 Non-defrosting freezer, −20°C Y N NA

Enter comment

Indicate if manual (non-digital) thermometers are present inside each piece
Question Number of equipment. (Select NA if the lab does not have the equipment.) Answer Comment
Enter comment

Enter comment
1.59 Hot air oven (for recharging desiccants) Y N NA

Enter comment
1.60 Hot plate with magnetic stir bar (for mixing powdered media) Y N NA
Enter comment

Enter comment
TEMPERATURE AND ATMOSPHERE MONITORING

Question Number Question Answer Comment
Observe if acceptable min/max temperature ranges have been clearly defined
Instructions for on record sheets for the following areas/equipment and if temperature checks place holder place holder
are documented daily. Select NA if the piece of equipment in question is not in

items below.
use in the lab.

Topic for 2
questions below. Room temperature place holder place holder
1.62 Are temperatures recorded each day of use? Y N

Enter comment
Is the acceptable temperature range (the minimum and maximum) clearly

Enter comment
1.63 Y N
defined on the record sheet?
Freezers, −20°C
Topic for 2 place holder place holder
questions below.
1.64 Are temperatures recorded each day of use? Y N NA

Enter comment

Enter comment
1.65 Y N NA
Freezers, −60°C
questions below.

Enter comment

Enter comment
1.67 Y N NA
Freezers, −80°C
questions below.

Enter comment

Enter comment
1.69 Y N NA
Refrigerators
questions below.

Enter comment

Enter comment
1.71 Y N
Incubators, ambient atmosphere
questions below.

Enter comment

Enter comment
1.73 Y N
Incubators, CO2
questions below.

Enter comment

Enter comment
1.75 Y N NA
Are CO2 incubators checked for adequate CO2 levels and documented daily
Enter comment
1.76 Y N NA
(or each day of use if not used daily)?
Water baths
questions below.

Enter comment

Enter comment
1.78 Y N NA
Standard for item Standard: Acceptable ranges should be defined for all temperature place holder place holder
dependent equipment
above.

Question Number Question Answer Comment
Is there documentation of corrective action taken in response to out of range
Enter comment
temperatures?
1.79 1: Yes 1 2 3
2: No action is documented
3: Temperatures are not recorded
Standard for item Standard: Procedures should be available with instruction as to what place holder place holder
action(s) should be taken when temperatures are out of range

above.
AUTOCLAVE MANAGEMENT
Question Number
Instructions for 3 Do records demonstrate that the following mechanical indicators are recorded place holder place holder
each time the autoclave is run? (Review logs to confirm)

items below.
1.80 Temperature Y N NA
Enter comment
1.81 Pressure Y N NA
Enter comment
1.82 Cycle Time Y N NA

Enter comment
Do records demonstrate that chemical indicators (e.g., heat sensitive tape) are
Enter comment
1.83 Y N NA
used each time the autoclave is run? (Review logs to confirm)
Do records demonstrate that biological indicators (e.g., Attest or other spore
Enter comment
system) are used to confirm the autoclave is achieving sterilization? (Review

logs to confirm).
1.84 1: Weekly 1234
2: Monthly
3: Less than monthly
4: No records
1.85 Is the same autoclave used for both media preparation and waste sterilization? Y N NA
Enter comment
INSTRUMENT AVAILABILITY AND MAINTENANCE

Question Number
Question Answer D (#) Comment
Instructions for
items below. Enter quantities in column D (#) place holder
place
holder
place holder
Does the laboratory have an automated blood culture instrument? BRAND:

Enter
number
1.86 Y N
(indicate manufacturer and model in comments)
1.87 Is the instrument functional today? Y N NA place Enter comment
holder
1.88 Is a user manual present? Y N NA place Enter comment

holder
1.89 Are routine (user) maintenance records present? Y N NA place Enter comment
holder
1.90 Are preventive (vendor) maintenance records present? Y N NA place Enter comment
holder
1.91 Is a service contract in place? Y N NA place Enter comment

holder
1.92 Is the software up to date? Y N NA place Enter comment

holder
Does the laboratory have an automated instrument for bacterial ID and BRAND:
Enter
number
1.93 Y N
AST? (e.g., Vitek, Microscan, Phoenix)
holder

holder
holder
holder

holder

holder
Does the laboratory have an automated instrument for reading disk BRAND/ MODEL:
Enter
number
1.100 Y N
diffusion? (e.g., SIRSCAN, BIOMIC V3, ADAGIO, etc.)
holder

holder
holder
holder

holder

holder

Question Number
Question Answer D (#) Comment
Does the lab have a MALDI instrument for organism ID? (e.g., Bruker, BRAND/ MODEL:
Enter
number
1.107 Y N
Biomerieux)
holder

holder
holder
holder

holder

holder
Does the lab have a PCR instrument used for detecting antibiotic BRAND/ MODEL:
Enter
number
1.114 Y N
resistance genes? (e.g., GeneXpert)
holder

holder
holder
holder

holder

holder
In the last 6 months, has prolonged instrument failure disrupted the

Enter comment
1.121 Y N place
ability to provide routine bacteriology services?

holder
In the event of prolonged instrument failure, is a contingency plan in

Enter comment
1.122 Y N place
place to provide uninterrupted bacteriology services?

holder
INVENTORY & STOCK OUTS

Question Number
1.123 Does the lab have an inventory control system in place? Y N
Enter comment
In the last 6 months, has the lab/hospital experienced stock outs of specimen
Enter comment
1.124 Y N
collection materials? (e.g., blood culture bottles, sterile cups, sterile swabs)
In the last 6 months, has the lab experienced stock outs of consumables? (e.g.,
Enter comment
1.125 petri dishes, tubes, sterile saline, pipettes, pipette tips, plastic inoculating Y N
loops, gloves, paper, gauze, disinfectant)
In the last 6 months, has the lab experienced stock outs of media? (e.g.,
Enter comment
1.126 Y N
powdered media, sheep blood, other additives, tubed media)
In the last 6 months, has the lab experienced stock outs of conventional
Enter comment
1.127 reagents? (e.g., oxidase reagent, indole reagent, catalase reagent, coagulase Y N
reagent, etc.)
In the last 6 months, has the lab experienced stock outs of antibiotic disks or
Enter comment
1.128 Y N
strips?
In the last 6 months, has the lab experienced stock outs of ID or AST
Enter comment
1.129 Y N NA
cards/trays for the automated instruments?
In the last 6 months, has the lab experienced stock outs of control materials or
Enter comment
1.130 Y N
reference strains?
1.131 In the last 6 months, has the lab experienced stock outs of other key materials? Y N
Enter comment
In the last 6 months, have any stock outs disrupted the lab's ability to provide
Enter comment
1.132 Y N
routine bacteriology services?
In the event of stock outs, is a contingency plan in place to provide
Enter comment
1.133 Y N
uninterrupted bacteriology services?
Standard: Testing services should not be subject to interruption due to stock
Standard for item outs. Laboratories should pursue all options for borrowing stock from another place holder place holder
laboratory or referring samples to another testing facility while the stock out
above.
is being addressed.
Are all currently in use media, reagents and test kits within the manufacturer-
Enter comment
1.134 Y N
assigned expiry dates? (Verify by random sampling)
Standard: All reagent and test kits in use, as well as those in stock, should be
Standard for item
above. within the manufacturer-assigned expiry dates. Expired stock should not be place holder place holder
entered into use and should be documented before disposal.

Question Number
Are all reconstituted reagents, such as coagulase plasma, within stability from
Enter comment
1.135 the date of reconstitution? (Coagulase plasma expires 30 days after Y N NA

reconstitution when stored frozen).

2 - LABORATORY INFORMATION SYSTEM (ELECTRONIC)
If the laboratory does not use an electronic LIS, answer No to question 2.1, then skip to 3 - Data Management
The scores for this section reflect the usability of the computer-based LIS and its likely compatibility with AMR surveillance systems,
not the quality of the laboratory.
When exporting data from a LIS for data analysis purposes, including AMR surveillance, it is important that each data field is discrete.
DEMOGRAPHIC DATA FIELDS
Question Number
Does the laboratory use a computer-based Laboratory Information System (LIS)? Name of LIS:
2.1 Y N
If yes, please record name in comments. PLEASE NOTE: WHONET is not a LIS
Instructions for 8 Observe data entry into the LIS. Are individual data fields present for each of the place holder place holder
following?
items below.
2.2 Patient Last Name/Surname Y N

Enter comment
2.3 Patient First Name Y N

Enter comment
2.4 Patient Identification Number Y N

Enter comment
2.5 Patient Date of Birth Y N

Enter comment
2.6 Patient Age Y N

Enter comment
2.7 Patient Gender Y N

Enter comment
2.8 Patient Location (Ward or Unit at the time of specimen collection, e.g., "ICU") Y N
Enter comment
2.9 Patient Date of Admission Y N

Enter comment
SPECIMEN DATA FIELDS

Question Number
Instructions for 8 Observe data entry into the LIS. Are individual data fields present for each of the place holder place holder
following?
items below.
2.10 Specimen identification number Y N

Enter comment
2.11 Specimen Type (e.g. Wound) Y N

Enter comment
2.12 Specimen Source/Body Site (e.g., Arm) Y N

Enter comment
2.13 Additional descriptors (e.g., Left, Right) Y N

Enter comment
2.14 Date of specimen collection Y N

Enter comment
2.15 Time of specimen collection Y N

Enter comment
2.16 Date of specimen receipt Y N

Enter comment
2.17 Time of specimen receipt Y N

Enter comment
CULTURE OBSERVATION DATA FIELDS

Question Number
Question for Observe culture data entry into the LIS. Are individual data fields present for place holder place holder
each of the following?

items below.
Topic for items

below. Gram stain of specimen (e.g., sputum Gram stain) place holder place holder
2.18 Quantity of Epithelial Cells per low power field Y N

Enter comment
2.19 Quantity of PMNs (WBCs) per low power field Y N

Enter comment
2.20 Quantity of bacterial cells per high power field Y N

Enter comment
2.21 Type of bacterial cells (gram-positive cocci, gram-negative bacilli, etc.) Y N

Enter comment
Description of colony morphologies (e.g., "mucoid lactose fermenter" or

Enter comment
2.22 Y N
"beta-hemolytic")
Description of colony quantities (e.g., "1+, 2+, 3+, 4+" or "few, moderate,
Enter comment
2.23 Y N
many")
2.24 Gram stain of bacterial colony Y N
Enter comment
Biochemical test results (e.g., "catalase-positive") for conventional test

Enter comment
2.25 Y N
methods
2.26 Organism name Y N
Enter comment
Isolate number (e.g., when more than one pathogen is encountered in a

Enter comment
2.27 Y N
culture: isolate #1, isolate #2)

AST DATA FIELDS
Question Number
Can the LIS record the AST method used to obtain each individual antibiotic
Enter comment
2.28 Y N
result (e.g., Etest vs. Vitek vs. disk)?
Instructions for Observe data entry into the LIS. Are individual data fields present for each of place holder place holder
the following?
items below.
2.29 Disk diffusion zone sizes Y N

Enter comment
2.30 Disk diffusion interpretation (S/I/R) Y N

Enter comment
2.31 MIC values Y N

Enter comment
2.32 MIC interpretation (S/I/R) Y N

Enter comment
2.33 Can the LIS record MIC values to three decimal places (e.g., 0.016)? Y N
Enter comment
Can the LIS suppress (hide) an individual antibiotic result from the patient
Enter comment
2.34 Y N
report without deleting it from the database (for cascade reporting)?
Does the LIS software automatically interpret zone sizes into Susceptible,
Enter comment
2.35 Y N
Intermediate, Resistant?
Does the LIS software automatically interpret MICs into Susceptible,
Enter comment
2.36 Y N
Intermediate, Resistant?
If the LIS software automatically interprets zone sizes or MICs, are the
Enter comment
2.37 Y N
breakpoints updated annually?
If the LIS software automatically interprets zone sizes or MICs, are the
Enter comment
2.38 Y N
breakpoints up to date today?
REPORTS AND DATA TRANSFER CAPABILITIES

Question Number
Instructions for (An “interface” is an electronic connection that allows information to flow place holder place holder
automatically between different computer systems and software applications)

items below.
Can the LIS de-duplicate data based on select criteria (e.g., patient ID, organism,
Enter comment
2.39 Y N
specimen date)?
2.40 Can the LIS produce a cumulative antibiogram report? Y N
Enter comment
Can the LIS interface with automated AST instruments (e.g., Vitek, Phoenix,
Enter comment
2.41 Y N
SIRScan, BIOMIC)?
2.42 Can the LIS interface with the Hospital Information System (HIS)? Y N
Enter comment
2.43 Can the LIS export line lists of data to .txt or .csv files? Y N
Enter comment
INTERFACE CONNECTIVITY
Question Number
Instructions for (An “interface” is an electronic connection that allows information to flow place holder place holder
automatically between different computer systems and software applications)

items below.
If the lab uses an automated AST instrument, describe the data flow between
Enter comment
the LIS and the instrument software.

1: Systems are not currently interfaced
2: Bidirectional: Patient information (e.g., medical record number,
specimen number, specimen type) flows from the LIS into the
instrument software, AND results (ID and AST) flow from the
1234
2.44 instrument software back into the LIS.
NA
3: Uni-directional: Patient information flows from the LIS into the
instrument software, but results do not transmit back into the LIS
4: Uni-directional: Results transmit from the instrument software into the
LIS, but patient information cannot flow from the LIS into the
instrument software.
NA: no automated instruments
Does the hospital use a Hospital Information System (HIS) or Electronic Medical
Enter comment
Y N
2.45 Record (EMR)?
NA
If yes, please record system name in comments

Question Number
If the LIS and HIS/EMR are interfaced, describe the data flow between the LIS
Enter comment
and the HIS/EMR

1: Systems are not interfaced
2: Bidirectional: Patient information (e.g., demographics, lab orders) flows
from the HIS into the LIS, AND patient microbiology (ID/AST) results
1234
2.46 flow from the LIS back into the HIS.
NA
3: Uni-directional: Patient demographics transmit from the HIS into the
LIS, but patient results do not transmit back into the HIS
4: Uni-directional: Patient results transmit from the LIS into the HIS, but
patient demographics cannot transmit from the HIS into the LIS.
NA: no LIS or no HIS

3- DATA MANAGEMENT
Please note: all questions refer only to clinical patient specimens, NOT to research specimens
PATIENT AND SPECIMEN IDENTIFICATION

Question Number
Are inpatients assigned a unique patient ID number upon admission to the
Enter comment
3.1 Y N
hospital?
Are outpatients assigned a unique patient ID number upon registration at the
Enter comment
3.2 Y N
clinic?
Are patient ID numbers assigned in such a way that no two patients are given
Enter comment
3.3 Y N
the same number in the course of one year?
Do patients retain the same patient ID number each time they are admitted to
Enter comment
3.4 Y N
the hospital?
Does the laboratory use the same patient ID numbers assigned by the hospital
Enter comment
3.5 Y N
and/or clinics?
Does the laboratory assign a unique specimen ID number to each specimen
Enter comment
3.6 Y N
received in the lab?
Are specimen numbers assigned in such a way that no two specimens are given
Enter comment
3.7 Y N
the same number during one year?
SPECIMEN REQUISITION FORM

Question Number
Instructions for Review the specimen requisition form. Does it contain each of the following place holder place holder
data fields?
items below.
3.8 Patient Name Y N

Enter comment

Enter comment
3.10 Patient Date of Birth or Age Y N

Enter comment
3.11 Patient Location (Ward or unit at time of specimen collection, e.g., "ICU") Y N
Enter comment
3.12 Specimen Type (e.g., Wound) Y N

Enter comment

Enter comment

Enter comment

Enter comment
3.16 Test order (e.g., culture & AST) Y N

Enter comment
3.17 Name of physician ordering the test Y N

Enter comment
3.18 Name or initials of person collecting specimen Y N

Enter comment
ORDER ENTRY
Question Number
Instructions for Review the process of specimen receiving/order entry. Are each of the following place holder place holder
variables captured in the logbook or computer system?

items below.
3.19 Patient Name Y N

Enter comment

Enter comment
3.21 Patient Date of Birth or Age Y N

Enter comment
3.22 Patient Location (Ward or unit at time of specimen collection, e.g., "ICU") Y N
Enter comment
3.23 Specimen Type (e.g., Wound) Y N

Enter comment

Enter comment

Enter comment

Enter comment
3.27 Date of specimen receipt Y N

Enter comment
3.28 Time of specimen receipt Y N

Enter comment
3.29 Test order (e.g., culture & AST) Y N

Enter comment
3.30 Name of physician ordering the test Y N

Enter comment
3.31 Name or initials of person receiving specimen Y N

Enter comment

CULTURE OBSERVATIONS
Question Number
The work card is where culture observations and biochemical test results are
Instructions for recorded. Work cards may be paper or electronic. place holder place holder
Review the work card of a recently completed culture.

items below.
Are the following elements recorded?

Topic for
questions below. Gram stain of specimen (e.g., sputum Gram stain) place holder place holder
3.32 Quantity of Epithelial Cells per low power field Y N

Enter comment
3.33 Quantity of PMNs (WBCs) per low power field Y N

Enter comment
3.34 Quantity of bacterial cells per high power field Y N

Enter comment
3.35 Type of bacterial cells (gram-positive cocci, gram-negative bacilli, etc.) Y N

Enter comment
Description of colony morphologies (e.g. "mucoid lactose fermenter" or

Enter comment
3.36 Y N
"beta-hemolytic")
Description of colony quantities (e.g. "1+, 2+, 3+, 4+" or "few, moderate,
Enter comment
3.37 Y N
many")
Gram stain of bacterial growth colonies (gram-positive cocci, gram-negative
Enter comment
3.38 Y N
bacilli, etc.)
Biochemical test results (e.g., "catalase positive") for conventional test
Enter comment
3.39 Y N
methods
3.40 AST Method used for each antibiotic (e.g., Disk, Etest, Instrument) Y N
Enter comment
3.41 Disk diffusion zone sizes Y N

Enter comment
3.42 Disk diffusion interpretation (S/I/R) Y N

Enter comment
3.43 MIC values Y N

Enter comment
3.44 MIC interpretation (S/I/R) Y N

Enter comment
Describe the laboratory’s system for recording culture observations

Enter comment
1: Laboratory Information System (LIS)

2: Fully electronic, but non-LIS (e.g., Word, Excel)
123
3.45 3: Handwritten on a paper work card (e.g., the back of the specimen
45
requisition) or in a logbook
4: Combination of handwritten and electronic recording
5: Internal results are not routinely recorded
Are culture observations/work cards retained for a defined time period (at least
Enter comment
3.46 Y N
one year)?
AST RESULTS REPORTING

Question Number
Describe the laboratory’s system for reporting AST results to the
Enter comment
physician/client
1: Fully electronic system – physician does not receive a paper report from
3.47 123
the lab
2: Combination of paper and electronic reporting
3: Fully paper-based system
If AST results are fully or partially issued to physicians on paper, please describe
Enter comment
that system.
1: Printout from the Laboratory Information System
3.48 1234
2: Printout from the ID/AST instrument (e.g., Vitek, Phoenix, etc.)
3: Printout from a non-LIS computer program (e.g., Word, Excel)
4: Primarily hand-written onto a paper form
3.49 Are AST reports retained for a defined time period (at least one year)? Y N
Enter comment

DATA BACKUP & SECURITY
Question Number
What method is used to back up the lab’s electronic patient records?
Enter comment
1: Facility or cloud server

2: External hard drive, USB, or CD 1234
3.50
3: Internal hard drive (PC or laptop) NA
4: None
NA: do not use an electronic database for patient records
How frequently are the lab’s electronic records backed up?
Enter comment
1: Daily/Continuously
3.51 2: Other frequency, specify in comments 1 2 3 NA
3: Never
NA: no electronic database
Does the lab or facility have a policy and/or SOP on data backup and
Enter comment
3.52 Y N NA
restoration?
Does the lab or facility have a policy and/or SOP on data security and
Enter comment
3.53 Y N NA
confidentiality?
3.54 Do laboratory computers have antivirus software? Y N NA
Enter comment
3.55 Do laboratory computers have genuine (not pirated) Operating Systems? Y N NA

Enter comment
AMR DATA SHARING

Question Number
Instructions for
items below. Is the laboratory currently a member of any AMR Surveillance Systems? place holder place holder
3.56 WHO GLASS (Global Antimicrobial Resistance Surveillance System) Y N

Enter comment
3.57 Other, please describe in comments Y N

Enter comment
Which of the following methods are currently used to submit data to the AMR
Instructions for
items below. surveillance network(s)? More than one method may be selected. If the lab place holder place holder
does not currently participate in AMR surveillance, select NA

3.58 Lab sends paper forms to an AMR coordinator Y N NA
Enter comment
3.59 Lab types data into an Excel spreadsheet Y N NA

Enter comment
3.60 Lab types data into an online database Y N NA

Enter comment
3.61 Lab types data into WHONET Y N NA

Enter comment
3.62 Lab exports a file from the automated AST instrument Y N NA

Enter comment
3.63 Lab exports a file from the LIS Y N NA

Enter comment
Instructions for If the lab has ever tried to use BacLink to transfer data from the LIS into place holder place holder
WHONET, were any of the following problems encountered?

items below.
3.64 The LIS export file was missing some of the required data fields Y N NA
Enter comment
The LIS export file merged/combined different data fields into a single
Enter comment
3.65 Y N NA
column
3.66 The LIS export file does not distinguish antibiotic results by AST method Y N NA
Enter comment
3.67 The LIS export file does not contain zone sizes or MIC values Y N NA
Enter comment
3.68 Other, please describe in comments Y N NA

Enter comment
If the lab has ever tried to use BacLink to transfer data from the automated
Instructions for
items below. AST instrument into WHONET, were any of the following problems place holder place holder
encountered?
The instrument export file was missing some of the required data fields (like
Enter comment
3.69 Y N NA
patient demographics)
The instrument export file merged/combined different data fields into a
Enter comment
3.70 Y N NA
single column
3.71 The instrument export file was missing MIC values Y N NA
Enter comment
3.72 The instrument export file was missing SIR values Y N NA

Enter comment
3.73 Other, please describe in comments Y N NA

Enter comment

4- QUALITY ASSURANCE
QUALITY STRUCTURE/BASICS
Question Number
Is there a Quality Manual in place that conforms to ISO standards? (15189,
Enter comment
4.1 Y N
17025 or 9001)?
4.2 Does the lab have a formally designated Quality Officer or Manager? Y N
Enter comment
Is there a Quality Focal Point in bacteriology, in charge of collaboration with

Enter comment
4.3 Y N
quality manager?
Is there documentation showing that the Quality Officers and Focal Points
Enter comment
have received appropriate training in Quality Management Systems (QMS)?

4.4 1: Yes 123
2: Some, but would like additional training
3: No training documented
How often does a Supervisor or Quality Officer review Media QC, ID QC, and
Enter comment
AST QC results?
4.5 1234
1: Weekly 3: Sporadically
2: Monthly 4: Never
Is there evidence that QC review is performed at the stated frequency?
Enter comment
1: Yes, for all QC results

4.6 123
2: Yes, but only for some QC results
3: No
Is there documentation showing that the Supervisor/Quality Officer received
Enter comment
training on how to effectively troubleshoot QC failures?

4.7 1: Yes 123
3: No training documented
Does a Supervisor or qualified designee review positive culture results every
Enter comment
4.8 Y N
day?
Are there written guidelines stating who is permitted to modify erroneous lab
Enter comment
4.9 Y N
results after they have been reported?
Who is permitted to modify erroneous lab results?
Enter comment
4.10 1: Supervisors and/or persons with supervisory permission - 12

2: All microbiologists
When corrections to patient results are made, what is done with the
Enter comment
erroneous result?
1: Erroneous results remain in place but are amended to reflect that
4.11 123
they are erroneous
2: Erroneous results are deleted from the record
3: Other (explain in comments)
LABORATORY STAFF EDUCATION/TRAINING/COMPETENCY

Question Number
Does at least 50% of the technical staff possess formal education in
Enter comment
4.12 Y N
microbiology or medical laboratory science?
Is the lab sufficiently staffed to provide high quality services? (Including
Enter comment
4.13 Y N
support staff)
4.14 Does the lab have a standardized process for training new employees? Y N
Enter comment
Does the lab have up-to-date documentation showing which benches & tests
Enter comment
4.15 each staff member has been trained on and approved to work Y N
independently? (Review such records)
Do records demonstrate that lab staff receive annual competency
Instructions for
items below. assessments for each of the following? (Review competency records, select place holder place holder
NA if not on lab's test menu)

4.16 Blood culture Y N NA
Enter comment
4.17 Urine culture Y N NA

Enter comment

Question Number
4.18 Stool culture Y N NA
Enter comment
4.19 Respiratory culture (non-TB) Y N NA

Enter comment
4.20 Wound culture Y N NA

Enter comment
4.21 Cerebrospinal Fluid Cultures Y N NA

Enter comment
4.22 Sterile Body Fluid Cultures Y N NA

Enter comment
4.23 Antibiotic Susceptibility Testing Y N NA

Enter comment
Standard: Newly hired lab staff should be assessed for competency before
performing independent duties and again within six months. All lab staff should
be regularly assessed for testing competency at least once a year. Staff
assigned to a new section should be assessed before fully assuming
independent duties. When deficiencies are noted, retraining and reassessment
Standard for item
above. should be planned and documented. If the employee’s competency remains place holder place holder
below standard, further action might include supervisory review of work, re-
assignment of duties, or other appropriate actions. Records of competency
assessments and resulting actions should be retained in personnel files and/or
quality records. Records should show which skills were assessed, how those
skills were measured, and who performed the assessment.
TOUBLESHOOTING, PROBLEM SOLVING, AND ROOT CAUSE ANALYSES
Question Number
Is a root cause analysis performed when unacceptable QC results are
Enter comment
4.24 Y N
obtained? (Request to see a recent example)
Is corrective action based on the findings of the root cause analysis
Enter comment
4.25 Y N
documented?
Is there evidence the supervisor or Quality Officer has received adequate
Enter comment
training on how to perform root-cause analysis of QC failures?

4.26 1: Yes 123
3: No
Are patient results reported if QC of media, ID method, or AST method was
Enter comment
4.27 Y N
not performed?
Are patient results reported if QC of media, ID method, or AST method failed
Enter comment
4.28 Y N
to produce acceptable results?
Is there evidence that the lab troubleshoots unacceptable QC results for
Enter comment
4.29 Y N
media, reagents, ID systems and AST methods?
If automated instruments are used for ID, (e.g., Vitek, Phoenix, Microscan) is
Enter comment
there user manual or SOP that describes how to troubleshoot instrument

4.30 Y N NA
failures?
Check NA if lab does not use automated instrument
EXTERNAL QUALITY ASSESSMENT (EQA)

Question Number
How many times per year does the lab currently receive EQA/PT challenges
Enter comment
that include both bacterial identification & AST? (Please do not include
challenges designed to focus on a single organism, e.g., TB or N. gonorrhoeae)
4.31 1: One time per year 1234
2: Two times per year
3: Three times per year or more
4: Zero (if zero, please answer question 4.32, then skip to 5 – Media QC)
If the lab does not participate in an EQA program, what is the reason?
Enter comment
4.32 place holder
(Informational, not scored)

Is the EQA/PT provider ISO-17043 accredited?
Enter comment
4.33 Y N
Please list provider in comments
Are the test methods used on EQA isolates the same as the test methods
Enter comment
4.34 Y N
used for routine patient isolates?

Question Number
Does the lab ever perform additional testing on an EQA isolate compared to
Enter comment
4.35 Y N
what would be performed on a typical patient isolate?
Does the lab ever send EQA isolates to another lab for confirmation before
Enter comment
4.36 Y N
submitting results?
Does the lab ever call another lab to ask what their EQA result was before
Enter comment
4.37 Y N
submitting results?
Are PT/EQA specimens tested by the same staff performing patient testing?
Enter comment
4.38 (Look for evidence that all staff participate in the challenges, not only Y N
supervisors or senior staff)
On average, how long does the lab have to wait before receiving the results of
Enter comment
their PT/EQA performance?

4.39 1 2 3 NA
1: Less than 2 months 3: More than 6 months
2: 2 – 6 months NA: no EQA
Review the 3 most recent EQA challenges for organism identification. On how
Enter comment
123
4.40 many did the lab score ≥ 80%?
None
If scores are not made available to review, select "None"
Review the 3 most recent EQA challenges for AST. On how many did the lab
Enter comment
123
4.41 score ≥80%?
None
If scores are not made available to review, select "None"
Is a root cause analysis performed when unacceptable PT/EQA results are
Enter comment
4.42 Y N
obtained? (Request to see a recent example)
Is corrective action based on the findings of the root cause analysis
Enter comment
4.43 Y N
documented?
Is there evidence the supervisor or Quality Officer has received adequate
Enter comment
training on how to perform root-cause analysis for EQA failures?

4.44 1: Yes 123
3: No
Is laboratory leadership notified of all unacceptable EQA results as soon as
Enter comment
4.45 Y N
they are received?

5- MEDIA PREPARATION AND QUALITY CONTROL
MEDIA PREPARATION SOPs
Question Number
Are media-specific SOPs in place for each type of media reconstituted in
Enter comment
5.1 Y N NA
house?
Instructions for
items below. Do all media preparation records including the following? place holder place holder
5.2 Name of media Y N NA

Enter comment
5.3 Date of preparation Y N NA

Enter comment
5.4 Batch number Y N NA

Enter comment
5.5 Quantity made Y N NA

Enter comment
5.6 pH Y N NA
Enter comment
5.7 Name of preparer Y N NA

Enter comment
5.8 Expiration Date Y N NA

Enter comment
Instructions for Observe the media reconstituted in house, is each batch clearly labeled with place holder place holder
the following?
items below.
5.9 Name of media Y N NA

Enter comment
5.10 Date of preparation Y N NA

Enter comment
5.11 Expiration date Y N NA

Enter comment
5.12 Date opened Y N NA

Enter comment
GENERAL MEDIA PREPARATION

Question Number
Is media prepared in a separate room, apart from the room where specimens
Enter comment
5.13 Y N
and cultures are processed?
5.14 Is media prepared in a clean room? Y N
Enter comment
5.15 Is deionized water (DI) or distilled water used to prepare all media? Y N
Enter comment
5.16 Are the media suspensions mixed with a magnetic stir bar while boiling? Y N
Enter comment
Is the dissolved suspension autoclaved in a clean autoclave at 15 psi, 121°C, for

Enter comment
5.17 Y N
≥15 minutes?
Is the autoclaved suspension cooled to 45-50°C before adding additional
Enter comment
5.18 Y N
compounds (e.g. blood)?
What is the source of the blood used to make the blood agar, chocolate,
Enter comment
and/or MHB plates?

5.19 1: Sheep’s blood 1 2 3
2: Human blood (e.g., from expired packed cells)
3: Other source (please describe in comments)
5.20 Is the pH recorded for all media prepared in house? Y N
Enter comment
5.21 Is all prepared media stored at 2-8°C until use? Y N

Enter comment
5.22 Are plates stored inside bags/sleeves to avoid dehydration? Y N

Enter comment
DISTILLED/DEIONIZED WATER PREPARATION

Question Number
Instructions for If the lab or facility produces its own distilled or deionized water, are QC place holder place holder
records present for the following?

items below.
5.23 Conductimetry Y N NA
Enter comment
5.24 pH Y N NA
Enter comment
5.25 Sterility Y N NA
Enter comment
If the lab purchases distilled or deionized water, does it come with a Certificate
Enter comment
5.26 Y N NA
of Analysis demonstrating proper pH, sterility and conductimetry?
ROUTINE MEDIA QC
Question Number
Are new batches of media checked for sterility by incubating a portion of un-
Enter comment
5.27 Y N
inoculated plates?

Question Number
Are media quality controlled by using ATCC or ATCC-derivative strains?
Enter comment
1: All
5.28 123
2: Some
3: None
Do records demonstrate that QC is performed on each newly reconstituted
Enter comment
5.29 Y N
batch or newly received lot number/shipment of media?
Do QC records for blood agar plates (BAP) demonstrate that they are checked
Enter comment
5.30 for their ability to support growth of fastidious organisms such as Y N

Streptococcus pneumoniae?
Do QC records for BAP demonstrate that they are checked for their ability to
Enter comment
5.31 Y N
show alpha, beta, and gamma hemolysis?
Do QC records for chocolate agar plates demonstrate that they are checked for
Enter comment
5.32 their ability to support the growth of fastidious organisms, such as Neisseria Y N
gonorrhoeae or Haemophilus influenzae?
MacConkey (MAC) and Eosin methylene blue (EMB) agars contain bile salts
Enter comment
and/or dyes that are toxic for gram-positive bacteria when made properly.
5.33 Y N NA
Do QC records for MAC and/or EMB plates demonstrate that each batch/lot is
challenged using a gram-positive organism?
Dyes and pH indicators in MAC and EMB plates provide a color indicator to
Enter comment
distinguish between lactose fermenting (LF) and non-lactose fermenting (NLF)

5.34 gram-negative organisms. Do QC records for MAC and/or EMB plates Y N NA
demonstrate that each batch/lot is challenged using both LF and NLF
organisms?
Do QC records for selective stool agar plates (e.g. XLD, SS, HE) demonstrate
Enter comment
5.35 that they are checked for their ability to suppress the growth of gram-positive Y N NA
organisms?
Do QC records for selective stool agar plates demonstrate that they are
Enter comment
5.36 checked for their ability to make hydrogen sulfide (H2S) production visible Y N NA
using an H2S producing organism, such as Salmonella spp or Proteus vulgaris?
Do QC records for selective stool agar plates demonstrate that they are
Enter comment
5.37 checked for their ability to make the acid byproducts of carbohydrate Y N NA
fermentation visible using both fermenters and non-fermenters?
Standard: CAP MIC.21300; SANAS TG 28-02: 6.1 The suitable performance of
culture media, diluents, and other suspensions prepared in-house should be
Standard for item checked, where relevant, with regard to recovery or survival maintenance of place holder place holder
target organisms, inhibition or suppression of non-target organisms,

above.
biochemical (differential and diagnostic) properties, physical properties (e.g.,

pH, volume, and sterility).
MULLER HINTON MEDIA PREPARATION AND QC
Question Number
Instructions for
items below. Examine the lab’s Mueller Hinton plates and SOP for the following: place holder place holder
Does the dehydrated Mueller Hinton Agar (dHMA) meet ISO 16782 (CLSI
Enter comment
5.38 M6) standards? (Low thymine/thymidine content, not supplemented with Y N NA

Mg++ or Ca++ cations)
5.39 Does the lab add calcium or magnesium cations to dMHA? Y N
Enter comment
Immediately after autoclaving, is agar allowed to cool in a 45° - 50°C water

Enter comment
5.40 Y N NA
bath?
Do plates have a uniform depth of approximately 4mm? Verify by examining
Enter comment
5.41 Y N
a recent batch.
5.42 Are plates poured on a level surface? Y N
Enter comment
5.43 Do records demonstrate that pH is 7.2 – 7.4 for each batch? Y N NA

Enter comment
Do records indicate that sterility is checked for each batch? (By incubating a
Enter comment
5.44 Y N
portion of un-inoculated plates, ideally 5%)
5.45 Are plates stored at 2-8°C until use? Y N
Enter comment

Question Number
5.46 Are plates stored inside bags/sleeves to avoid dehydration? Y N
Enter comment
Do QC records indicate that each batch of Mueller Hinton (MHA) agar is

Instructions for
items below. checked for its ability to produce expected zone sizes using the following ATCC place holder place holder
reference strains and antibiotics?

5.47 Pseudomonas aeruginosa 27853 and gentamicin disk Y N
Enter comment
Enterococcus faecalis 29212 or 33186 and trimethoprim-sulfamethoxazole

Enter comment
5.48 Y N
disk
Do QC records indicate that each batch of Mueller Hinton Blood (MHB) agar is
Enter comment
checked for its ability to produce expected zone sizes using Streptococcus
5.49 Y N NA
pneumoniae ATCC 49619 (or equivalent)?
Check NA if the lab does not use MHB
BLOOD CULTURE BOTTLES PREPARATION AND QC

Question Number
Does the lab prepare blood culture bottles in-house?
Enter comment
5.50 Y N
If no, answer NA to remaining questions
Which base broth is used? (Broth must support growth of a wide range of
Enter comment
bacterial species) 1
1: Brain Heart Infusion 2
2: Supplemented peptone 3
3: Soybean-casein digest (tryptic soy) 4
5.51 4: Thioglycolate 5
5: Thiol 6
6: Colombia 7
7: Brucella 8
8: Other NA
NA
Is sodium polyanethole sulfonate (SPS) added? (an anticoagulant and growth
Enter comment
5.52 Y N NA
stabilizer)
Are any growth-promoters added? (Such as: Gelatin, Yeast Extract, Hemin (X-
Enter comment
5.53 factor), NAD (Y-factor), Pyridoxine, Para-amino benzoic acid, Cysteine) Y N NA

If yes, please describe in comments
Are resins or charcoal added? (to bind antimicrobials present in the patient's
Enter comment
5.54 blood) Y N NA
If yes, please describe in comments
Is 50mL of broth dispensed into sterile bottles for adult patients? (1:5
Enter comment
5.55 Y N NA
blood:broth ratio)
Is 25mL of broth dispensed into sterile bottles for pediatric patients? (1:5
Enter comment
5.56 Y N NA
blood:broth ratio)
5.57 Are the bottles autoclaved at 121°C for ≥15 min? Y N NA
Enter comment
Instructions for
items below. Do QC records for blood culture bottles indicate the following: place holder place holder
5.58 Visual inspection performed and documented Y N NA

Enter comment
Checked for sterility by incubating a portion of uninoculated bottles? (Ideally

Enter comment
5.59 Y N NA
5%)
5.60 Ability to support growth of Streptococcus pneumoniae Y N NA
Enter comment
5.61 Ability to support growth of Haemophilus influenzae Y N NA

Enter comment
Near the expiration date, is QC repeated on a few of the bottles to confirm the
Enter comment
5.62 Y N NA
long-term stability of the broth?
Are unused bottles labeled correctly (name, batch #, production date and
Enter comment
5.63 Y N NA
expiration date)?

6- QUALITY CONTROL - ID METHODS
GRAM STAIN QC and REAGENT LABELING AND STORAGE
Question Number
Is QC performed and results recorded on each new preparation or lot number of
Enter comment
Gram stain reagents?

6.1 1: Yes 1 2 3
2: Partial
3: No
Standard: CAP MIC.21540, MIC.21624 All staining procedures (Gram stains,
Standard for item
above. special stains, and fluorescent stains) should be checked and results recorded for place holder place holder
each new batch of stain.

Is Gram stain QC performed using both positive and negative control
Enter comment
6.2 Y N
organisms?
Observe the Gram stain, catalase, coagulase, oxidase and indole reagents in use
by the laboratory. Are they labeled with:
Instructions for
items below. 1: All place holder place holder
2: Some
3: None
6.3 Name of reagent 123
Enter comment
6.4 Date of preparation/reconstitution (if relevant, e.g., coagulase) 123

Enter comment
6.5 Date of opening 123

Enter comment
6.6 Expiration date 123

Enter comment
Are tubed media, reagents, and kits stored at the temperatures indicated by the
Enter comment
6.7 Y N
manufacturer?
QC OF INDIVIDUAL BIOCHEMICAL METHODS

Question Number
NOTE: This question applies only to the tubed media and liquid reagents in use
by the lab.
Information and
instructions for
questions below.
It does NOT apply to the biochemical reagent wells incorporated into pre- place holder place holder
defined identification systems, such as Vitek, API, Liofilchem, etc.

Do QC records demonstrate the following? If a reagent is not used, check NA
Topic for
questions below. Catalase (H2O2) place holder place holder
6.8 Positive control is used Y N NA

Enter comment
6.9 Negative control is used Y N NA

Enter comment
6.10 QC is performed on each new batch/lot number Y N NA

Enter comment
6.11 QC is performed using ATCC or ATCC-derivative strains Y N NA

Enter comment
Topic for 4
questions below. Coagulase plasma place holder place holder

Enter comment

Enter comment

Enter comment

Enter comment
Topic for 4
questions below. Staphylococcus latex agglutination place holder place holder

Enter comment

Enter comment

Enter comment

Enter comment
Topic for 4
questions below. Staphylococcus Chromagar place holder place holder

Enter comment

Enter comment

Enter comment

Enter comment

Question Number
Topic for 4
questions below. DNase place holder place holder

Enter comment

Enter comment

Enter comment

Enter comment
Topic for 4
questions below. PYR place holder place holder

Enter comment

Enter comment

Enter comment

Enter comment
Topic for 4
questions below. Optochin ("P") disk place holder place holder

Enter comment

Enter comment

Enter comment

Enter comment
Topic for 4
questions below. Bile solubility (deoxycholate) place holder place holder

Enter comment

Enter comment

Enter comment

Enter comment
Topic for 4
questions below. Streptococcus pneumoniae latex agglutination place holder place holder

Enter comment

Enter comment

Enter comment

Enter comment
Topic for 4
questions below. Oxidase place holder place holder

Enter comment

Enter comment

Enter comment

Enter comment
Topic for 4
questions below. Indole reagents place holder place holder

Enter comment

Enter comment

Enter comment

Enter comment
Topic for 4
questions below. Methyl Red place holder place holder

Enter comment

Enter comment

Enter comment

Enter comment
Topic for 4
questions below. Voges-Proskauer place holder place holder

Enter comment

Enter comment

Enter comment

Enter comment
Topic for 4
questions below. Citrate place holder place holder

Enter comment

Enter comment

Enter comment

Enter comment

Question Number
Topic for 4
questions below. Triple Sugar Iron agar or Kligler Iron Agar place holder place holder

Enter comment

Enter comment

Enter comment

Enter comment
Topic for 4
questions below. Urease place holder place holder

Enter comment

Enter comment

Enter comment

Enter comment
Topic for 4
questions below. Motility place holder place holder

Enter comment

Enter comment

Enter comment

Enter comment
Topic for 4
questions below. Lysine Iron Agar (LIA) or Lysine decarboxylase (LDC) place holder place holder

Enter comment

Enter comment

Enter comment

Enter comment
Topic for 4
questions below. Glucose or Dextrose Oxidative-Fermentative (OF) test place holder place holder

Enter comment

Enter comment

Enter comment

Enter comment
Topic for 4
questions below. Nitrate reduction place holder place holder

Enter comment

Enter comment

Enter comment

Enter comment
Topic for 4
questions below. Gelatin hydrolysis place holder place holder

Enter comment

Enter comment

Enter comment

Enter comment
Topic for 4
questions below. Chloramphenicol resistance (disk) place holder place holder

Enter comment

Enter comment

Enter comment

Enter comment
Topic for 4
questions below. Growth at 42°C place holder place holder

Enter comment

Enter comment

Enter comment

Enter comment
Standard: CAP MIC.21624 Positive and negative controls must be tested and
Standard for item
above. recorded for all differential test procedures. Controls must be performed and place holder place holder
recorded at the specific periodic intervals listed for the tests.

QC OF ENTERIC SEROLOGY
Question Number
Indicate whether the following aspects of QC for Salmonella and/or Shigella
Instructions for
items below. serology reagents are performed. place holder place holder
If serology testing is not performed, check NA.

Topic for 4
questions below. Shigella serogoup place holder place holder

Enter comment

Enter comment

Enter comment

Enter comment
Topic for 4
questions below. Salmonella serotype place holder place holder

Enter comment

Enter comment

Enter comment

Enter comment
QC OF COMMERCIAL ID KITS and AUTOMATED ID SYSTEMS

Question Number
Review QC records for commercial organism identification kits (e.g., API,
Instructions for
items below. Liofilchem, RapID) place holder place holder
Check NA if the lab does not use any commercial test kits for organism ID
Is QC performed on every new lot number/shipment before kits are placed
Enter comment
6.108 Y N NA
into use, according to manufacturer recommendations?
6.109 Is QC performed using ATCC or ATCC-derivative strains? Y N NA
Enter comment
Following manufacturer instructions, are all of the recommended ATCC

Enter comment
strains in use for the identification kits?

1: All recommended strains are used; 123
6.110
2: Some of the recommended strains are used; NA
3: None of the recommended reference strains are used;
NA
Review the QC records for the ID cards/trays used with automated ID
Instructions for
items below. instruments (e.g., Vitek, Phoenix, Microscan, etc.) Check NA if the lab does not place holder place holder
use automated systems for organism ID

Is QC performed on every new lot number/shipment of ID cards/trays before
Enter comment
6.111 Y N NA
they are placed into use?
6.112 Is QC performed using ATCC or ATCC-derivative strains? Y N NA
Enter comment
Following manufacturer instructions, are all of the recommended ATCC

Enter comment
strains in use for the automated instrument ID cards/trays?

1: All recommended strains are used; 123
6.113
2: Some of the recommended strains are used; NA
3: None of the recommended reference strains are used;
NA

7- QUALITY CONTROL - AST METHODS
ROUTINE AST REFERENCE STRAINS
Question Number
Instructions for Does the lab have the following ATCC reference strains in stock? (CIP place holder place holder
equivalents are also shown)

items below.
7.1 Staphylococcus aureus ATCC 25923/CIP 76.25 (If CLSI standard used) Y N NA
Enter comment
7.2 Staphylococcus aureus ATCC 29213/CIP 103429 (If EUCAST standard used) Y N NA
Enter comment
Enterococcus faecalis ATCC 29212/CIP 103214 (to assess suitability of

Enter comment
7.3 Y N NA
Mueller Hinton Agar for trimethoprim-sulfonamide tests)
7.4 Streptococcus pneumoniae ATCC 49619 Y N
Enter comment
7.5 E. coli ATCC 25922/CIP 76.24 Y N

Enter comment
7.6 Pseudomonas aeruginosa ATCC 27853/CIP 76.110 Y N

Enter comment
Instructions for
items below. Are reference strains stored as follows? place holder place holder
Reference cultures (lyophilized state, from the manufacturer) maintained at

Enter comment
7.7 Y N NA
<−20°C
Reference stock cultures (broth preparations of reference cultures)
Enter comment
maintained at
7.8 Y N NA
<−20°C in a suitable stabilizer (10% -15% glycerol in tryptic soy broth, 50%
fetal calf serum in broth, defibrinated sheep blood, or skim milk)
Monthly working stock culture, or "F1", stored at 2-8°C for up to 4 weeks,
Enter comment
7.9 Y N NA
then discarded
Weekly working stock culture, or “F2”, stored at 2-8°C for up to 1 week, then
Enter comment
7.10 Y N NA
discarded
7.11 Daily subculture, or “F3”, discarded after one day of use. Y N NA
Enter comment
Standard: SANAS TG 28-02: 7.2.2 A reference culture is a microorganism

preparation that is obtained from a culture type collection such as ATCC. A
Standard for item reference stock culture is a microorganism preparation derived from a place holder place holder
reference culture. A working stock culture is growth derived from a reference

above.
stock culture. A subculture is the transfer of established microorganism

growth on media to fresh media.
SPECIAL AST REFERENCE STRAINS
Question Number
Instructions for Does the lab have the following reference strains in stock? (CIP equivalents are place holder place holder
also shown)
items below.
7.12 Staphylococcus aureus ATCC 43300 (mecA positive, MRSA) Y N NA

Enter comment
7.13 Staphylococcus aureus ATCC BAA-976 (msrA positive, Dzone negative) Y N NA

Enter comment
7.14 Staphylococcus aureus ATCC BAA-977 (ermA positive, Dzone positive) Y N NA

Enter comment
7.15 Enterococcus faecalis ATCC 51299/CIP 104676 (vanB positive, VRE) Y N

Enter comment
7.16 E. coli ATCC 13353 (CTX-M-15 ESBL positive) Y N

Enter comment
7.17 E. coli ATCC 35218 (TEM-1 positive) Y N

Enter comment
7.18 Klebsiella pneumoniae ATCC 700603 (SHV-18, OXA-2) ESBL test QC Y N

Enter comment
Klebsiella pneumoniae ATCC BAA-1705 (TEM, SHV, KPC-2) Carbapenemase

Enter comment
7.19 Y N
test QC
Klebsiella pneumoniae ATCC BAA-1706 (Resistant to carbapenems by non-
Enter comment
7.20 Y N
carbapenemase method)
Instructions for 1 Some QC strains with plasmid-mediated resistance have been shown to lose the place holder place holder
plasmid when stored at temperatures above −60°C

item below.
7.21 Are these special AST reference strains maintained at <−60°C? Y N NA Enter comment

QC OF DISC DIFFUSION AST METHODS
Question Number
Does the lab perform the disk diffusion method of AST?
Enter comment
7.22 Y N
If No, answer NA until 7.31
Is antibiotic disk QC performed before placing newly received lot
Enter comment
7.23 Y N NA
numbers/shipments into use? (Review QC records to confirm)
IMPORTANT! Please read the information below before proceeding:
CLSI and EUCAST require that all antibiotic QC is performed each day of
patient testing, not only when a new lot number is received.
Instructions for
items below. Labs that wish to reduce the frequency of antibiotic QC from daily to weekly place holder place holder
may do so after demonstrating satisfactory performance with daily QC using

one of two plans described in CLSI M02, section 4.7. Either the 20-30 day plan,
or the 15-replicate plan.
Is there documentation showing that the lab has successfully completed either
Enter comment
7.24 the 20-30-day plan or the 15-replicate (3- x 5-day) plan for all antibiotic disks in Y N
use? (Request to see)
Not including new lot QC, how often is antibiotic disk QC performed? (Confirm
Enter comment
by reviewing QC records; go back several months)

1: Each day that disk AST is performed on patients
2: Weekly 1 2 3 4
7.25
3: Every other week 5 NA
4: Monthly
5: Other (describe in comments)
NA: disk method not used
Instructions for 5 Is antibiotic disk QC performed using the recommended ATCC reference strains place holder place holder
below? (Review QC records to confirm)

items below.
Enter comment
Enter comment
7.28 E. coli ATCC 25922/CIP 76.24 Y N NA

Enter comment
7.29 Pseudomonas aeruginosa ATCC 27853//CIP 76.110 Y N NA

Enter comment
7.30 Streptococcus pneumoniae ATCC 49619 Y N NA

Enter comment
QC OF GRADIENT STRIP AST METHODS

Question Number
Does the lab use the gradient strip method of AST (Etest/Liofilechem)?
Enter comment
7.31 (ungraded) Y N
If no, answer NA until 7.40
Is gradient strip QC performed before placing new lot numbers/shipments into
Enter comment
7.32 Y N NA
use? (Review QC records to confirm)
Enter comment
7.33 the 20-30 day plan or the 15-replicate (3- x 5-day) plan for all antibiotic strips in Y N NA
use? (Request to see)
Not including new lot QC, how often is antibiotic strip QC performed? (Confirm
Enter comment
by reviewing QC records; go back several months)

1: Each day that strip AST is performed on patients
2: Weekly 1 2 3 4
7.34
4: Monthly
NA: strip method not used
Instructions for 5 Is antibiotic strip QC performed using the recommended ATCC reference strains place holder place holder
below? (Review QC records to confirm)

items below.
Enter comment
Enter comment

Enter comment

Question Number
Enter comment

Enter comment
QC OF AUTOMATED AST SYSTEMS

Question Number
Does the lab use an automated instrument for AST? (e.g., Vitek, Phoenix,
Enter comment
7.40 Microscan, etc) Y N

If No, then enter NA until the end of this section
Are the antibiotic cards/trays stored at the manufacturer-recommended
Enter comment
7.41 Y N NA
temperatures?
Is QC of the antibiotic cards/trays performed before placing new lot
Enter comment
7.42 Y N NA
numbers/shipments into use? (Review QC records to confirm)
Enter comment
7.43 the 20-30-day plan or the 15-replicate (3- x 5-day) plan for all antibiotic Y N NA
cards/trays in use? (Request to see)
Not including new lot QC, how often is antibiotic card/tray QC performed?
Enter comment
(Confirm by reviewing QC records; go back several months)

1: Each day that automated AST is performed on patients
2: Weekly 1234
7.44
4: Monthly
NA: automated method not used
Instructions for 5 Is QC of automated AST systems performed using the recommended ATCC place holder place holder
reference strains below? (Review QC records to confirm)

items below.
Enter comment
Enter comment

Enter comment

Enter comment

Enter comment

8- SPECIMEN COLLECTION, TRANSPORT & MANAGEMENT
Please note: all questions refer only to clinical patient specimens, NOT to research or environmental specimens.
SPECIMEN MANAGEMENT
Question Number
Does lab policy require that all specimens are accompanied by a laboratory-
Enter comment
8.1 Y N
approved test requisition form?
Does the lab enforce a two-identifier system? (e.g., both patient name and a
Enter comment
8.2 Y N
numeric identifier must be present on the requisition and on the specimen).
8.3 Are sensitive specimens processed within one hour of reaching the laboratory? Y N
Enter comment
When the bacteriology lab is closed, does another laboratory department

Enter comment
8.4 process (culture) the specimens or ensure that they are stored at the proper Y N NA
temperatures? (Select NA if bacteriology lab does not close)
Instructions for
items below. Does the lab store specimens properly prior to and following testing? place holder place holder

Enter comment

Enter comment

Enter comment
8.8 Respiratory culture Y N NA

Enter comment

Enter comment
8.10 Genital culture Y N NA

Enter comment
8.11 Cerebrospinal fluid culture Y N NA

Enter comment
8.12 Sterile body fluid culture (pleural, pericardial, peritoneal, synovial) Y N NA

Enter comment
Standard: ISO 15189: 5.4.1, 5.4.5, 5.4.7, 5.4.8, 5.4.10, 5.4.11, 5.4.13 Standard: ISO
Standard for item 15189: 5.2.9, 5.4.14, 5.7.3 Specimens should be stored under the appropriate place holder place holder
conditions to maintain the stability of the specimen. Specimens no longer required

above.
should be disposed of in a safe manner, according to biosafety regulations

SPECIMEN REJECTION
Question Number
Instructions for
items below. Are rejection criteria written down in an SOP or bench aide for each specimen type? place holder place holder

Enter comment

Enter comment

Enter comment
8.16 Respiratory culture Y N NA

Enter comment

Enter comment
8.18 Genital culture Y N NA

Enter comment
8.19 Cerebrospinal fluid culture Y N NA

Enter comment
8.20 Sterile body fluid culture (pleural, pericardial, peritoneal, synovial) Y N NA

Enter comment
8.21 Are unlabeled specimens rejected? Y N

Enter comment
8.22 Are mislabeled specimens rejected? Y N

Enter comment
8.23 Are leaking specimens rejected? Y N

Enter comment
8.24 Are specimens rejected if not transported to the lab within established time limits? Y N
Enter comment
Are specimens rejected if there is evidence that they were not maintained in proper
Enter comment
8.25 Y N
conditions during and prior to transport?
8.26 Is there evidence that specimen rejection criteria are enforced (review rejection log)? Y N
Enter comment
Does the lab maintain quality indicators regarding the number of specimens
Enter comment
8.27 Y N
rejected?
When specimens are rejected, does the lab notify the ward or clinic
Enter comment
8.28 Y N
immediately so that a new specimen may be collected?
BLOOD SPECIMEN COLLECTION and TRANSPORT

Question Number
Does the lab provide blood culture specimen collection instructions/SOPs to
Enter comment
8.29 Y N
patient sample collection areas?

Question Number
Does the lab (or other department) provide annual training to clinical staff on
Enter comment
8.30 Y N
blood culture specimen collection?
Review the blood culture specimen collection instructions. Does it address the
Instructions for
11 items below. following items? (If specimen collection instructions do not exist or are not place holder place holder
available to review, answer "No" to each.)

8.31 Collect prior to administering antibiotics to patient Y N
Enter comment
8.32 Antiseptic skin preparation and aseptic collection technique Y N

Enter comment
8.33 Antiseptic stopper preparation and aseptic inoculation of bottles Y N

Enter comment
8.34 Minimum volume for adults (typically 10-15mL per bottle) Y N NA

Enter comment
8.35 Minimum volume for children (typically 5-10mL per bottle) Y N NA

Enter comment
8.36 Minimum volume for neonates (typically 0.5-1mL per bottle) Y N NA

Enter comment
8.37 Does laboratory policy require that two "sets" of blood cultures are drawn? Y N
Enter comment
Does the policy specify that each blood culture should be obtained from a
Enter comment
8.38 Y N
different venipuncture site?
8.39 Proper bottle labeling (patient name, ID, date, time, venipuncture site) Y N
Enter comment
8.40 Transport bottles to the lab within 1 hour of collection Y N

Enter comment
If transport will be delayed, store bottles for automated systems at room

Enter comment
8.41 Y N
temperature; store bottles for manual systems at 37°C.
URINE SPECIMEN COLLECTION and TRANSPORT

Question Number
Does the lab provide urine culture specimen collection instructions/SOPs to
Enter comment
8.42 Y N
Does the lab (or other department) provide annual refresher training to clinical
Enter comment
8.43 Y N
staff on urine culture specimen collection?
Instructions for 7 Review the urine culture specimen collection instructions. Does it address the place holder place holder
following items?
items below.
8.44 Antiseptic cleaning instructions for women, men and infants Y N

Enter comment
8.45 Mid-stream or "clean catch" instructions Y N

Enter comment
8.46 Sterile containers only Y N

Enter comment
8.47 Minimum volume (typically 3mL) Y N

Enter comment
8.48 Proper labeling instructions Y N

Enter comment
8.49 Transport to lab at room temperature within 2 hours of collection Y N

Enter comment
8.50 If transport will be delayed, store refrigerated for up to 24 hours Y N

Enter comment
STOOL SPECIMEN COLLECTION and TRANSPORT

Question Number
Does the lab provide stool culture specimen collection instructions/SOPs to
Enter comment
8.51 Y N
Does the lab (or other department) provide annual refresher training to clinical
Enter comment
8.52 Y N
staff on stool culture specimen collection?
Instructions for 7 Review the stool culture specimen collection instructions. Does it address the place holder place holder
following items?
items below.
8.53 Collection technique Y N

Enter comment
8.54 Approved containers Y N

Enter comment
8.55 Min/Max volume Y N

Enter comment
8.56 Proper labeling Y N

Enter comment
8.57 Transport to the lab at room temperature within 2 hours Y N

Enter comment
If transport will be delayed, place specimen in an approved transport

Enter comment
8.58 Y N
medium (such as Cary-Blair) for up to 24 hours
If transport will be delayed, do not refrigerate stool since some pathogens,
Enter comment
8.59 Y N
especially Shigella spp, will die at low temperatures

9- PROCESSING
Please note: all questions refer only to clinical patient specimens, NOT to research or environmental specimens.
BLOOD CULTURE PROCESSING
Question Number
Does the laboratory perform blood cultures? Y N
Instructions for Enter comment
items below.
Does the laboratory have an SOP describing how to process blood for bacterial
Enter comment
9.1 Y N NA
culture?
When a blood culture bottle shows signs of positivity, (turbidity, hemolysis, or
Enter comment
9.2 Y N NA
gas production), does the lab perform a Gram stain of the bottle broth?
If the Gram stain from the bottle is positive, does the lab call the result to the
Enter comment
9.3 Y N NA
physician immediately?
When a positive blood culture broth is sub-cultured, is a chocolate plate
Enter comment
9.4 Y N NA
included to ensure recovery of fastidious organisms?
9.5 Does the lab inoculate more than one patient sample on the same petri dish? Y N NA
Enter comment
Does the SOP for blood cultures appropriately define which organisms are
Enter comment
commonly considered contaminants?

9.6 E.g., Corynebacterium spp., Propionibacterium spp., Micrococcus spp., Y N NA
viridans Strep spp., Bacillus spp., and coagulase-negative Staph spp. isolated
from only one culture
9.7 Does the lab perform AST on organisms that are possible contaminants? Y N NA
Enter comment
Which blood culture incubation systems does the lab use?

Enter comment
1: Automated only
9.8 1 2 3
2: Manual System only
3: Both automated and manual systems
MANUAL BLOOD CULTURE SYSTEMS

Question Number
Review the SOP for manual incubation of blood culture bottles. Does it include
Question for 6
items below. each of the following instructions? (If only automated systems are used, place holder place holder
answer NA)
On each day of incubation, visually examine all bottles for signs of positivity
Enter comment
9.9 Y N NA
(turbidity, hemolysis, gas production)
9.10 After 24 hours of incubation, subculture all bottles that appear negative Y N NA
Enter comment
After 48 hours of incubation, subculture all bottles that appear negative

Enter comment
9.11 Y N NA
again (if the first subculture was negative)
Subculture bottles that appear negative to a chocolate agar plate (incubated
Enter comment
9.12 Y N NA
in 5% CO2) to ensure recovery of fastidious organisms
Incubate all bottles between 5 and 7 days before issuing a final negative
Enter comment
9.13 Y N NA
report
On the final day of incubation, perform a terminal subculture before the
Enter comment
9.14 Y N NA
final negative report is issued
URINE CULTURE
Question Number
Does the laboratory perform urine cultures? Y N
No question Enter comment
number
Does the laboratory have an SOP for how to process urine for bacterial
Enter comment
9.15 Y N NA
culture? (request to see)
According to the SOP, which media are used for primary culture of urine?
Enter comment
1: Both blood agar and a selective gram-negative agar (e.g., MacConkey,

EMB, CLED)
9.16 1234
2: Chromogenic agar designed for urine specimens
3: Blood agar only
4: Other, describe

Question Number
Standard: CAP MIC.22210; SANAS TR 34-04:3.2.1.2 Media and procedures
Standard for item
above. must be used to ensure isolation and identification of common uro-pathogens place holder place holder
such as Enterobacteriaceae, Enterococcus sp., and Staphylococcus sp.

9.17 Are quantitative cultures (colony counts) performed? Y N NA
Enter comment
Standard: CAP MIC.22200; SANAS TR 34-04: 3.2.1.2 The minimal standards

Standard for item
above. for evaluation of urine cultures should include an estimate of number of place holder place holder
organisms, i.e., quantitative culture expressed as CFU/L.

Are urines plated using a calibrated loop?
Enter comment
1: Yes, 1µL
9.18 123
2: Yes, 10uL
3: No, calibrated loops are not used to plate urines
Enter comment
Does the urine culture SOP provide guidance to the technologist in

Enter comment
9.20 determining which organisms to “work up” (ID and AST) based on relative Y N NA
quantities, pathogenicity, and method of specimen collection?
Have technologists been adequately trained to recognize a poorly collected
Enter comment
urine specimen (predominance of fecal or skin flora) based on the relative

quantities, types, and mix of organisms present?
9.21 123
1: Yes
3: No
STOOL CULTURES for Salmonella and Shigella

Question Number
Does the laboratory perform stool cultures? Y N
number
Does the laboratory have an SOP for how to process (plate) stool for bacterial
Enter comment
9.22 Y N NA
culture? (request to see)
Does the SOP describe how to identify potential pathogens on all primary
Enter comment
media?
9.23 The SOP should describe the colony appearance of potential pathogens on Y N NA
MAC other selective & differential media used and should define how to
proceed when a potential pathogen is encountered.
Topic for
questions below. Which media are used for primary culture of stool? place holder place holder
9.24 Blood agar Y N NA

Enter comment
9.25 MacConkey or Eosin Methylene Blue agar Y N NA

Enter comment
Selective and differential screening agar for Salmonella and Shigella (e.g.,
Enter comment
9.26 Salmonella/Shigella agar, Hektoen Enteric agar, Xylose Lysine Deoxycholate Y N NA

agar, or Deoxycholate Citrate Agar)
9.27 Selective enrichment broth (e.g., Selenite, GN, etc.) Y N NA
Enter comment
9.28 Other (describe in comments, not scored) Y N

Enter comment
Enter comment
Question for 3 Are the following pathogens routinely targeted in every stool culture place holder place holder
submitted?
items below.
9.30 Salmonella spp. Y N NA

Enter comment
Shigella spp. Y N NA
number
Other (describe in comments, not scored) Y N NA

number

10- IDENTIFICATION METHODS & STANDARD OPERATING PROCEDURES
Please note: all questions refer only to clinical patient isolates, NOT to research or environmental isolates.
CONVENTIONAL ID METHODS
Answer the questions below for each manual method/biochemical in use at the lab.
Definitions used in this section:
*"Fully implemented" means that the Standard Operating Procedure (SOP) has been approved and signed by a lab supervisor or
designee, and that laboratory staff have been trained on the contents and utilize the SOP. A SOP that is complete but has not been
approved or is not in routine use is not considered fully implemented.
**"Readily available" means that technologists can easily access the Standard Operating Procedure (SOP) at or near the bench,
either in electronic or paper form, and that the information sought is easily located within the SOP, not buried in a larger
document, and is written in a language that those using the SOP can read fluently.
STAPHYLOCOCCUS AUREUS, KEY ID METHODS
Question Number
Topic for
questions below. Catalase (H2O2) place holder
place holder
Is this reagent used to test patient isolates? (If No, select NA for the
Enter comment
10.1 Y N
remaining questions about this reagent)
Has an up-to-date SOP been fully implemented?* (If the reagent is in use but
Enter comment
10.2 Y N NA
there is no SOP, answer "no" to all remaining questions about this reagent)
10.3 Is the SOP readily available** to bench staff? Y N NA
Enter comment
10.4 Does the SOP define QC organisms, QC frequency, and expected QC results? Y N NA
Enter comment
Does the SOP provide stepwise instructions for how to perform the test
Enter comment
10.5 Y N NA
correctly?
Does the SOP provide stepwise instructions for interpreting the test result
Enter comment
10.6 Y N NA
correctly?
Is catalase testing performed prior to coagulase testing on suspected
Enter comment
Staphylococcus isolates?
10.7 1 2 3 NA
1: Always 3: Never
2: Sometimes NA
Topic for
questions below. Coagulase plasma place holder place holder
Enter comment
10.8 Y N
Enter comment
10.9 Y N NA
Enter comment
Enter comment
Enter comment
10.12 Y N NA
correctly?
Enter comment
10.13 Y N NA
correctly?
What is the source of the plasma used for coagulase testing?
Enter comment
1: Commercially purchased rabbit plasma

10.14 2: Locally bled rabbit 1234
3: Human plasma
4: Other source (please describe in comments)
Are negative slide coagulase results confirmed with a tube coagulase test
Enter comment
before being reported?

10.15 1 2 3 NA
1: Always 3: Never
2: Sometimes NA: lab does not perform slide coagulase testing

STAPHYLOCOCCUS AUREUS, OTHER ID METHODS
Question Number
Topic for
questions below. Staph latex agglutination place holder place holder
Enter comment
10.16 Y N
Enter comment
10.17 Y N NA
Enter comment
Enter comment
Enter comment
10.20 Y N NA
correctly?
Enter comment
10.21 Y N NA
correctly?
Are disposable reaction cards discarded after use (not reused)?
Enter comment
1: Always
10.22 2: Sometimes 1 2 3 NA
3: No
NA: lab does not use latex agglutination to identify Staphylococcus
Topic for
questions below. Staph chromagar place holder place holder
Enter comment
10.23 Y N
Enter comment
10.24 Y N NA
Enter comment
Enter comment
Enter comment
10.27 Y N NA
correctly?
Enter comment
10.28 Y N NA
correctly?
Topic for
questions below. DNase place holder place holder
Enter comment
10.29 Y N
Enter comment
10.30 Y N NA
Enter comment
Enter comment
Enter comment
10.33 Y N NA
correctly?
Enter comment
10.34 Y N NA
correctly?
STREPTOCOCCUS PNEUMONIAE, CONVENTIONAL ID METHODS

Question Number
Topic for
questions below. PYR place holder place holder
Enter comment
10.35 Y N
Enter comment
10.36 Y N NA
Enter comment
Enter comment
Enter comment
10.39 Y N NA
correctly?
Enter comment
10.40 Y N NA
correctly?

Question Number
Topic for
questions below. Bile solubility (deoxycholate) place holder place holder
Enter comment
10.41 Y N
Enter comment
10.42 Y N NA
Enter comment
Enter comment
Enter comment
10.45 Y N NA
correctly?
Enter comment
10.46 Y N NA
correctly?
Topic for
questions below. Optochin (“P”) disk place holder place holder
Enter comment
10.47 Y N
Enter comment
10.48 Y N NA
Enter comment
Enter comment
Enter comment
10.51 Y N NA
correctly?
Enter comment
10.52 Y N NA
correctly?
If the Optochin result is equivocal (9-13mm), is bile solubility or other
Enter comment
10.53 Y N NA
additional testing performed to confirm the ID?
Topic for
questions below. Streptococcus pneumoniae latex agglutination place holder place holder
Enter comment
10.54 Y N
Enter comment
10.55 Y N NA
Enter comment
Enter comment
Enter comment
10.58 Y N NA
correctly?
Enter comment
10.59 Y N NA
correctly?
ENTEROBACTERIACEAE, CONVENTIONAL ID METHODS

Question Number
Topic for
questions below. Oxidase place holder place holder
Enter comment
10.60 Y N
Enter comment
10.61 Y N NA
Enter comment
Enter comment
Enter comment
10.64 Y N NA
correctly?
Enter comment
10.65 Y N NA
correctly?
Topic for
questions below. Indole place holder place holder
Enter comment
10.66 Y N

Question Number
Enter comment
10.67 Y N NA
Enter comment
Enter comment
Enter comment
10.70 Y N NA
correctly?
Enter comment
10.71 Y N NA
correctly?
Topic for
questions below. Methyl Red place holder place holder
Enter comment
10.72 Y N
Enter comment
10.73 Y N NA
Enter comment
Enter comment
10.76 Does the SOP provide stepwise instructions for inoculation and incubation? Y N NA
Enter comment
10.77 Does the SOP provide stepwise instructions for reading and interpretation? Y N NA
Enter comment
Topic for
questions below. Voges-Proskauer place holder place holder
Enter comment
10.78 Y N
Enter comment
10.79 Y N NA
Enter comment
Enter comment
Enter comment
Enter comment
Topic for
questions below. Citrate place holder place holder
Enter comment
10.84 Y N
Enter comment
10.85 Y N NA
Enter comment
Enter comment
Enter comment
Enter comment
Topic for
questions below. Triple Sugar Iron (TSI) or Kligler Iron Agar (KIA) place holder place holder
Enter comment
10.90 Y N
Enter comment
10.91 Y N NA
Enter comment
Enter comment
Enter comment
Enter comment
Topic for
questions below. Urease place holder place holder
Enter comment
10.96 Y N
Enter comment
10.97 Y N NA
Enter comment
Enter comment
Enter comment

Question Number
Enter comment
Topic for
questions below. Motility place holder place holder
Enter comment
10.102 Y N
Enter comment
10.103 Y N NA
Enter comment
Enter comment
Enter comment
Enter comment
Topic for
questions below. Lysine Iron Agar (LIA) or Lysine Decarboxylase (LDC) place holder place holder
Enter comment
10.108 Y N
Enter comment
10.109 Y N NA
Enter comment
Enter comment
Enter comment
Enter comment
SHIGELLA/SALMONELLA SEROLOGY
Question Number
Topic for
questions below. Shigella serology place holder place holder
Is this reagent used to test patient isolates? (If No, select NA for the Enter comment
10.114 Y N
Has an up-to-date SOP been fully implemented?* (If the reagent is in use but Enter comment
10.115 Y N NA
10.116 Is the SOP readily available** to bench staff? Y N NA Enter comment
10.117 Does the SOP define QC organisms, QC frequency, and expected QC results? Y N NA Enter comment
Does the SOP provide stepwise instructions for how to perform the test Enter comment
10.118 Y N NA
correctly?
Does the SOP provide stepwise instructions for interpreting the test result Enter comment
10.119 Y N NA
correctly?
Topic for
questions below. Salmonella serology place holder place holder
Is this reagent used to test patient isolates? (If No, select NA for the Enter comment
10.120 Y N
Has an up-to-date SOP been fully implemented?* (If the reagent is in use but Enter comment
10.121 Y N NA
10.122 Is the SOP readily available** to bench staff? Y N NA Enter comment
10.123 Does the SOP define QC organisms, QC frequency, and expected QC results? Y N NA Enter comment
Does the SOP provide stepwise instructions for how to perform the test Enter comment
10.124 Y N NA
correctly?
Does the SOP provide stepwise instructions for interpreting the test result Enter comment
10.125 Y N NA
correctly?
ACINETOBACTER SPP, CONVENTIONAL ID METHODS

Question Number
Topic for
questions below. Glucose Oxidative-Fermentative (OF) test place holder place holder
Enter comment
10.126 Y N
Enter comment
10.127 Y N NA
Enter comment

Question Number
Enter comment
Enter comment
Enter comment
Topic for
questions below. Nitrate reduction place holder place holder
Enter comment
10.132 Y N
Enter comment
10.133 Y N NA
Enter comment
Enter comment
Enter comment
Enter comment
Topic for
questions below. Gelatin hydrolysis place holder place holder
Enter comment
10.138 Y N
Enter comment
10.139 Y N NA
Enter comment
Enter comment
Enter comment
Enter comment
Topic for
questions below. Chloramphenicol resistance (disk) place holder place holder
Enter comment
10.144 Y N
Enter comment
10.145 Y N NA
Enter comment
Enter comment
Enter comment
Enter comment
Topic for
questions below. Growth at 42°C place holder place holder
Enter comment
10.150 Y N
Enter comment
10.151 Y N NA
Enter comment
Enter comment
Enter comment
Enter comment
KIT-BASED ID METHODS
Question Number
If the lab uses rapid biochemical kits for organism ID (e.g., API, Liofilchem, RapID),
does the SOP for each kit contain the following information?
Question and
Instructions for 5
items below.
(If kits are not used, select "NA"; if kits are used but there is no SOP, select "3: No") place holder place holder
1: Yes 3: No
2: Partial NA: The lab does not use rapid biochemical kits
10.156 Defined QC organisms, QC frequency, and expected QC results 1 2 3 NA
Enter comment
Stepwise instructions for preparing the inoculum in the correct liquid

Enter comment
10.157 1 2 3 NA
medium and at the correct density
10.158 Stepwise instructions on how to inoculate and incubate the device 1 2 3 NA
Enter comment
Stepwise instructions on how to read the results, including use of additional

Enter comment
10.159 1 2 3 NA
reagents if necessary

Question Number
10.160 Clear guidance on interpreting results and recognizing unacceptable results 1 2 3 NA
Enter comment
Are the SOPs available in a language that the technologists can read
Enter comment
10.161 Y N NA
proficiently?
10.162 Is the lab using the inoculation media recommended by the manufacturer? Y N NA
Enter comment
Following device inoculation, does the lab use the remaining inoculum to make
Enter comment
a purity plate? (A purity plate is a light subculture of the inoculum that is made
10.163 to ensure the inoculum was not a mixed culture or contaminated; usually Y N NA
streaked like a urine to ensure visualization of individual colonies and checked
for purity when reading results)
Following incubation, are all supplemental reagents available and added
Enter comment
10.164 Y N NA
according to manufacturer instructions? (e.g., VP1 & 2 for API)
Y N NA
Enter comment
10.165 Are the databases used to interpret the kit results (bionumbers) up to date? Don’t
know
When an ID result (bionumber) does not reach the threshold for an acceptable
Enter comment
identification, is there evidence that appropriate action is taken, such as

10.166 Y N NA
repeating the test by another method or performing additional biochemical
tests?
AUTOMATED ID METHODS
Question Number
If the lab uses automated methods for organism ID (e.g., Vitek, Microscan,
Phoenix), do the SOPs contain the following information? (User manuals
Instructions for
items below. provided by the manufacturer are not considered SOPs) place holder place holder
1: Yes 3: No
2: Partial NA: automated methods are not used
10.167 Defined QC organisms, QC frequency, and expected QC results 1 2 3 NA
Enter comment
Stepwise instructions for preparing the inoculum in the correct liquid

Enter comment
10.168 1 2 3 NA
medium and at the correct density
10.169 Stepwise instructions on how to inoculate and incubate the device 1 2 3 NA
Enter comment
Stepwise instructions on how to read the results, including use of additional

Enter comment
10.170 1 2 3 NA
reagents if necessary
10.171 Clear guidance on interpreting results and recognizing unacceptable results 1 2 3 NA
Enter comment
Is the SOP available in a language that the technologists using the instrument
Enter comment
10.172 Y N NA
can read proficiently?
10.173 Is the lab using the inoculation medium recommended by the manufacturer? Y N NA
Enter comment
Following card/tray inoculation, does the lab use the remaining inoculum to
Enter comment
make a purity plate?

A purity plate is a light subculture of the inoculum that is made to ensure the
10.174 Y N NA
inoculum was not mixed or contaminated; usually streaked like a urine to
ensure visualization of individual colonies and checked for purity when reading
results. BAP is typically used.
When the instrument software flags an ID result as questionable, is there
Enter comment
10.175 evidence that appropriate action is taken, such as repeating the test by Y N NA
another method or performing additional biochemical tests?
IDENTIFICATION FLOWCHARTS
Question Number
For questions 10.176 to 10.184:
Instructions for 1: Always place holder place holder
2: Sometimes
items below.
3: Never
When the primary plate has mixed colony types, is it standard practice to
Enter comment
10.176 subculture each colony of interest to a fresh plate to ensure purity prior to 1 2 3
pursuing identification?

Question Number
Is it standard practice to perform a Gram stain on each isolate of interest prior
Enter comment
10.177 1 2 3
to performing any other testing?
For gram-negative bacilli, is it standard practice to perform an oxidase test
Enter comment
10.178 first, before proceeding with any other identification tests (including 1 2 3
automated ID)?
For gram-negative bacilli, is it standard practice to perform an indole test
Enter comment
10.179 second, before proceeding with other identification tests (including automated 1 2 3
ID)?
For oxidase-negative gram-negative bacilli that do not ferment lactose (clear
Enter comment
10.180 on MacConkey), are sufficient tests available to achieve a definitive 1 2 3

identification?
For oxidase-positive gram-negative bacilli that are not Pseudomonas
Enter comment
10.181 aeruginosa (lack the characteristic appearance and odor), are sufficient tests 1 2 3
available to achieve a definitive identification?
For gram-positive cocci, is it standard practice to perform a catalase test first,
Enter comment
10.182 before proceeding with any other identification tests (including automated 1 2 3
ID)?
For catalase positive gram-positive cocci, is it standard practice to perform a
Enter comment
10.183 coagulase test next, before proceeding with other identification tests 1 2 3
(including automated ID)?
For catalase negative gram-positive cocci, is it standard practice to evaluate
Enter comment
10.184 the type of hemolysis (alpha, beta, gamma), before proceeding with other 1 2 3
identification tests (including automated ID)?

11- ANTIMICROBIAL SUSCEPTIBILITY TESTING (AST) BASICS
ANTIBIOTIC DISK AND GRADIENT STRIPS MAINTENANCE

Question Number
Do the antibiotic disks and strips come with a certificate of analysis from the
Enter comment
11.1 manufacturer ensuring that they were tested and performed according to ISO Y N
quality standards?
Are the packages not currently in use stored unopened and in their original
Enter comment
11.2 Y N
packaging in order to prevent moisture ingress?
11.3 Are unopened antibiotic disks and strips stored in a non-defrosting freezer? Y N
Enter comment
If the antibiotic disk cartridge has a cap, is the cap replaced each time the
Enter comment
11.4 Y N
cartridge is opened?
Once opened, are in-use antibiotic disks stored in such a way that the lot
Enter comment
number and expiration date of each disk is always traceable? (When individual
11.5 Y N
disks are removed and transferred to secondary containers, lot numbers may
become mixed and expired disks may inadvertently be used.)
Are the in-use antibiotic disks and strips stored in a tightly sealed container
Enter comment
11.6 Y N
with active desiccants?
Do the desiccants change color as moisture levels increase (indicating the need
Enter comment
11.7 Y N NA
to replace or recharge)?
If desiccants do not have a color indicator, are colorless desiccants replaced at
Enter comment
11.8 Y N NA
least monthly?
Are the containers holding open antibiotic disks/strips stored in a refrigerator
Enter comment
11.9 Y N
or non-defrosting freezer when not in use?
Are the containers holding open antibiotic disks/strips allowed to equilibrate
Enter comment
11.10 to room temperature before opening to minimize condensation (typically 1 Y N

hour)
INOCULUM PREPARATION
Question Number
When preparing an inoculum using the colony suspension method, are
Enter comment
11.11 Y N
colonies less than 18 hours old ever used?
When preparing an inoculum using the colony suspension method, are
Enter comment
11.12 Y N
colonies more than 24 hours old ever used?
Observe an AST inoculum preparation. Do technologists use only individual,
Enter comment
11.13 Y N
well-isolated colonies of the same morphological type?
Are colonies taken only from non-selective media, such as blood agar
Enter comment
11.14 Y N
(MacConkey agar is acceptable)
Does the lab ever intentionally mix two different organisms in the same
Enter comment
11.15 Y N
inoculum for AST?
11.16 Is an appropriate, sterile inoculation medium (TSB or saline) used? Y N
Enter comment
Do records indicate that the saline solution is tested for sterility on a regular
Enter comment
11.17 Y N
basis? (Preferably at least weekly)
11.18 Is the inoculum brought to a density equivalent to 0.5 McFarland? Y N
Enter comment
How is the inoculum density checked for accuracy?

Enter comment
1: Calibrated densitometer/turbidity meter

11.19 2: Visual comparison to a 0.5 McFarland standard that is not expired 1 2 3
(check date)
3: Neither of the above

INOCULATION/INCUBATION
Question Number
Does the lab ever use agar other than Mueller Hinton for AST of non-fastidious
Enter comment
11.20 Y N
organisms?
Does the lab ever use agar other than Mueller Hinton with Blood for AST of
Enter comment
11.21 Y N
Streptococcus pneumoniae?
Instructions for
items below. Observe a MH plate being inoculated. place holder place holder
11.22 Is the inoculum always used within 15 minutes of preparation? Y N

Enter comment
11.23 Is a sterile swab used to inoculate the plate? Y N

Enter comment
Is the inoculum spread in a way that will create an even lawn?

Enter comment
To create an even lawn, streak a line from top to bottom, then spread left to
11.24 Y N
right across that line from top to bottom. Rotate plate 60° and repeat from
beginning; rotate plate another 60° and repeat again.
Before applying disks/strips, are inoculated MH plates allowed to sit, lid-ajar,
Enter comment
11.25 for 3 to no more than 15 minutes to allow for absorption of excess surface Y N
moisture?
11.26 Are disks/strips ever moved after being placed on the agar? Y N
Enter comment
When using multi-disk dispensers, is the bottom of the dispenser disinfected

Enter comment
11.27 Y N NA
between isolates?
11.28 Are AST plates incubated within 15 minutes of placing disks/strips? Y N
Enter comment
After AST inoculation, are “purity plates” made from the remaining
Enter comment
suspension?
A purity plate is a light subculture of the inoculum that is made to ensure the
11.29 Y N
inoculum was not mixed or contaminated; usually streaked like a urine to
ensure visualization of individual colonies and checked for purity when
reading AST results
11.30 Are AST plates for non-fastidious organisms ever incubated in CO2? Y N
Enter comment
11.31 Are AST plates for Streptococcus pneumoniae incubated in 5% CO2? Y N

Enter comment
Topic for Observe some currently incubating and/or recently read Mueller Hinton AST place holder Enter comment
plates.
questions below.
11.32 Are the lawns of growth confluent (no gaps or individual colonies showing)? Y N
Enter comment
11.33 Is there a maximum of 6 antibiotic disks per 100mm plate? Y N

Enter comment
11.34 Is there a maximum of 12 antibiotic disks per 150mm plate? Y N NA

Enter comment
Are disks spaced properly? (At least 24mm from center to center, no
Enter comment
11.35 Y N
overlapping zones, not too close to edge, uniformly circular zones)
READING AST RESULTS

Question Number
11.36 Are AST results ever read after less than 16 hours of incubation? Y N
Enter comment
11.37 Are AST results ever read after more than 24 hours of incubation? Y N
Enter comment
If individual colonies are apparent within the ellipsis or the zone of inhibition,
Enter comment
11.38 does the lab repeat the test with a fresh subculture of a single colony from the Y N
original plate?
Instructions for 4
items below. Observe a Mueller Hinton AST plate being read. place holder place holder
11.39 Is the plate held above a black, non-reflective background? Y N

Enter comment
11.40 Is the plate illuminated adequately with reflected light? Y N

Enter comment
11.41 Is the plate inverted and zones measured from underneath? Y N

Enter comment
11.42 Is a ruler or a caliper with millimeter marks used to measure zone sizes? Y N
Enter comment
Does the lab possess a guidance document with photos describing how to
Enter comment
11.43 measure zone sizes, such as the CLSI M02 or the EUCAST disk diffusion reading Y N
guides?
Does the lab possess a guidance document with photos describing how to
Enter comment
measure gradient strip endpoints?

11.44 Y N
For example, ETEST Reading Guide for Aerobic Bacteria [PDF - 2 pages]
(http://www.ilexmedical.com/files/ETEST_RG.pdf )
Question Number
Does the SOP or bench aide instruct that zone sizes and/or MIC endpoints for
Enter comment
11.45 co-trimoxazole (SXT) are measured at 80% inhibition of growth, rather than Y N
100%?
Does the SOP or bench aide instruct how to measure zones of inhibition and/or
Enter comment
11.46 Y N
MIC endpoints when Proteus spp. swarming is present?
Is the automated AST instrument software up to date?
Enter comment
11.47 Y N NA
Answer NA if the lab does not use automated AST instrument
INTERPRETING RESULTS
Question Number
Is there evidence that appropriate actions are taken when the AST instrument
Enter comment
software flags an AST result as questionable (such as checking for purity or

11.48 Y N NA
repeating the test by another method)?
Answer NA if the lab does not use automated AST instrument
Is there evidence that microbiology staff have received adequate training to
Enter comment
recognize intrinsic resistance patterns? (Check SOPs and training/competence

assessment records)
1: Yes
11.49 1 2 3
3: No
Note: Intrinsic resistance is defined as inherent or innate (not acquired)
resistance which is reflected in the wild-type of all representatives of a species;
e.g., Citrobacter spp. and Klebsiella spp. are intrinsically (naturally) resistant to
ampicillin.
Do the AST SOPs or bench aides provide examples of intrinsic resistance
Enter comment
patterns? (Such as those found in CLSI M100 Appendix B or EUCAST Expert

11.50 Y N
Rules V3.1)
Check SOPs and training/competence assessment records
Is there evidence that microbiology staff have received adequate training to
Enter comment
recognize unusual or unexpected AST results that might require investigation?

(e.g. Klebsiella spp. S to ampicillin; Staphylococcus spp. I/R to vancomycin)
11.51 Check SOPs and training/competence assessment records 1 2 3
1: Yes
3: No
Do the AST SOPs or bench aides define examples of unusual or unexpected AST
Enter comment
11.52 results? (Such as those found in CLSI M100 Appendix A or EUCAST Expert Rules Y N
V3.1)
Do the AST SOPs or bench aides describe what actions to take when unusual or
Enter comment
11.53 unexpected AST results are encountered (e.g., check purity, reconfirm Y N
organism ID, check relevant QC, repeat testing, notify supervisor)?
11.54 Is there evidence of such actions being taken? Y N
Enter comment
Is the microbiology lead or supervisor informed when unusual AST results are
Enter comment
11.55 Y N
identified?
Does a supervisor review all AST results for unusual findings before results are
Enter comment
11.56 Y N
given to physicians?
Is there evidence that the supervisor received appropriate training on how to
Enter comment
recognize unusual AST findings?

11.57 1: Yes 1 2 3
3: No

BREAKPOINTS STANDARDS
Question Number
Which AST breakpoint standard does the lab primarily use?
Enter comment
1: CLSI
11.58 2: EUCAST 1234
3: Other (please list in comments)
4: None/mixed
Ask to see the lab’s most current hard copy of the standard. Is it less than 3
Enter comment
11.59 Y N
years old?
11.60 Does the lab obtain updates of the standard in use at least every 3 years? Y N
Enter comment
Does the lab review important standards changes, e.g., breakpoint changes,
Enter comment
11.61 with the relevant hospital committees (e.g., pharmacy and therapeutics, Y N
stewardship)?
Is there internet in the lab to access free EUCAST PDFs or CLSI M100 online
Enter comment
version?
11.62 EUCAST Guidance Documents in Susceptibility Testing Y N
(http://www.eucast.org/ast_of_bacteria/guidance_documents/)
CLSI M100 and M60 (http://clsi-m100.com/)
Is there evidence that microbiology staff have received adequate training on
Enter comment
how to use the CLSI M100 or EUCAST documents effectively?

11.63 1: Yes 1 2 3
3: No
Instructions for
items below. For the next 3 questions, answer NA if the lab does not use considered disks place holder place holder
Look at the cefotaxime disks currently in use. Does the drug concentration
Enter comment
11.64 correspond correctly to the standard the lab uses? (CLSI breakpoints require Y N NA
30µg disks, EUCAST breakpoints require 5µg disks).
Look at the ceftazidime disks currently in use. Does the drug concentration
Enter comment
11.65 correspond correctly to the standard in use? (CLSI breakpoints require 30µg Y N NA
disks, EUCAST breakpoints require 10µg)
Look at the piperacillin-tazobactam disks currently in use. Does the drug
Enter comment
concentration correspond correctly to the standard in use? (CLSI

11.66 Y N NA
breakpoints require 100/10µg disks, EUCAST breakpoints require 30/6µg
disks).

12- AST EXPERT RULES
EXPERT RULES FOR SALMONELLA

Question Number
Review a patient AST report for a Salmonella or Shigella isolate. Were any of
the following drug classes tested or reported?
Instructions and
Question for
items below.
(These drugs may appear active in vitro but are not effective clinically against place holder place holder
Salmonella or Shigella and should not be reported as susceptible, regardless of

the AST result.)
1st generation cephalosporins (cefazolin, cephalothin, cephapririn,
Enter comment
12.1 Y N NA
cephadrine)
12.2 2nd generation cephalosporins (cefuroxime, cefonicid, cefamandole) Y N NA
Enter comment
12.3 Cephamycins (cefoxitin, cefotetan) Y N NA

Enter comment
12.4 Aminoglycosides (gentamicin, tobramycin, amikacin) Y N NA

Enter comment
Does the lab use Nalidixic Acid to screen Salmonella isolates for ciprofloxacin
Enter comment
12.5 Y N NA
resistance?
Compare the lab’s AST bench aids and SOPs to the Salmonella table in the
Enter comment
Assessor’s Guide. Does the lab use the correct fluoroquinolone (FQ)
12.6 Y N NA
breakpoints for Salmonella spp?
(Enterobacteriaceae FQ breakpoints should not be used for Salmonella spp).
GRAM NEGATIVES & BETA-LACTAM BREAKPOINTS

Question Number
IMPORTANT! Please read the information below before proceeding:
Beginning in 2009, CLSI and EUCAST lowered the breakpoints for several
beta-lactam antibiotics and Aztreonam in order to enhance the detection of
resistance.
Even if a laboratory has current CLSI or EUCAST manuals, they may have
failed to update their bench aids and SOPs to reflect current breakpoints.
Information and
Question for
items below.
Since the bench aids and SOPs are used by technologists for AST place holder place holder
interpretation, it is crucial that these are up to date as well.

The Assessor’s Guide shows the current breakpoints for these antibiotics.
Compare this table to the bench aids and SOPs the technologists use for zone
size and MIC interpretation.
Do the bench aids and SOPs have the current breakpoints for the following
combinations? (Select NA if the antibiotic is not in use)
12.7 Enterobacteriaceae and Aztreonam Y N NA
Enter comment
12.8 Enterobacteriaceae and Cefotaxime Y N NA

Enter comment
12.9 Enterobacteriaceae and Ceftriaxone Y N NA

Enter comment
12.10 Enterobacteriaceae and Ceftazidime Y N NA

Enter comment
12.11 Enterobacteriaceae and Cefepime Y N NA

Enter comment
12.12 Enterobacteriaceae and Imipenem Y N NA

Enter comment
12.13 Enterobacteriaceae and Meropenem Y N NA

Enter comment
12.14 Enterobacteriaceae and Ertapenem Y N NA

Enter comment
12.15 Enterobacteriaceae and Doripenem Y N NA

Enter comment
12.16 Acinetobacter and Imipenem Y N NA

Enter comment
12.17 Acinetobacter and Meropenem Y N NA

Enter comment
12.18 Acinetobacter and Doripenem Y N NA

Enter comment
12.19 Pseudomonas and Cefepime Y N NA

Enter comment
12.20 Pseudomonas and Piperacillin Y N NA

Enter comment
12.21 Pseudomonas and Piperacillin-Tazobactam Y N NA

Enter comment
12.22 Pseudomonas and Ticarcillin-Clavulanate Y N NA

Enter comment

Question Number
12.23 Pseudomonas and Imipenem Y N NA
Enter comment
12.24 Pseudomonas and Meropenem Y N NA

Enter comment
12.25 Pseudomonas and Doripenem Y N NA

Enter comment
PHENOTYPIC ESBL TESTING

Question Number
NOTE: Questions 12.26 and 12.27 only apply to labs that do NOT use current
Instructions for
items below. cephalosporin and aztreonam breakpoints. If this lab uses current place holder place holder
breakpoints, select NA for both questions and skip to question 12.28

Labs that do NOT use current cephalosporin and aztreonam breakpoints must
Enter comment
perform routine ESBL phenotype testing. For ESBL-positive isolates, all

12.26 penicillins, cephalosporins, and aztreonam that test susceptible must be Y N NA
reported as resistant. Is this practice (changing ESBL + interpretations from S to
R) in place?
Labs that do NOT use current aztreonam and cephalosporin breakpoints
Enter comment
should attach a warning comment to the report for ESBL-positive organisms:

12.27 Y N NA
“ESBL-producers should be considered clinically resistant to all penicillins,
cephalosporins, and aztreonam.” Is this practice in place?
For labs that DO use current cephalosporin and aztreonam breakpoints, CLSI
Enter comment
and EUCAST no longer recommend routine testing for ESBL phenotype.

Furthermore, if ESBL testing is performed and the test is positive,
interpretations for beta-lactam agents do NOT need to be changed from
12.28 Y N NA
susceptible to resistant. Has the lab discontinued editing AST results based on
the ESBL result?
Note: Select NA for the question above if the lab does NOT use current
cephalosporin and aztreonam breakpoints
Does the lab perform any phenotypic tests for ESBL production? Including
Enter comment
12.29 disks, gradient strips, or a screening well in an automated system. Y N

If no, answer NA until Phenotypic Carbapenemase Testing Section
Does the phenotypic ESBL method include testing both cefotaxime (or
Enter comment
12.30 Y N NA
ceftriaxone) AND ceftazidime alone and in combination with clavulanic acid?
12.31 Does the lab perform any genotypic tests for ESBL production? (e.g., PCR) Y N
Enter comment
Do records indicate that quality control for ESBL testing is done either on a
Enter comment
12.32 Y N NA
weekly basis or each time the test is performed?
Do records indicate that lab uses both positive and negative control organisms
Enter comment
12.33 to QC the ESBL test in use? (A commonly used ESBL-positive strain is Klebsiella Y N NA
pneumoniae ATCC 700603)
12.34 When an ESBL-positive is confirmed, is infection control notified by the lab? Y N NA
Enter comment
PHENOTYPIC CARBAPENEMASE TESTING

Question Number
Labs that do NOT use current carbapenem breakpoints must perform routine
Enter comment
testing for carbapenemase production (e.g., CarbaNP, mCIM, or a molecular

assay). If a carbapenemase is detected, all carbapenems that test susceptible
12.35 Y N NA
must be reported as resistant. Is this practice (changing results from S to R
based on positive carbapenemase test result) in place?
Note: Select NA if the lab uses current breakpoints
For labs that DO use current carbapenem breakpoints, CLSI and EUCAST no
Enter comment
longer recommend routine testing for carbapenemase production.

Furthermore, if such testing is performed and the test is positive,
12.36 interpretations for carbapenems do NOT need to be changed from susceptible Y N NA
to resistant. Has the lab discontinued editing AST results based on the
carbapenemase result?
Note: Select NA if the lab uses current breakpoints
Question for 11 Does the lab perform any of the following phenotypic tests for carbapenemase place holder place holder
production?
items below.

Question Number
12.37 Modified Hodge test Y N
Enter comment
12.38 Other disk method, e.g., combination disk test or double disk synergy Y N
Enter comment
12.39 MIC Strip test, e.g., Etest KPC, MBL or Liofilchem MRP/MBO, ETP/EBO Y N
Enter comment
12.40 Biochemical (colorimetric) test, e.g., CarbaNP, BCT, or β CARBA Y N

Enter comment
12.41 Chromogenic agar specific for carbapenemase producers Y N

Enter comment
12.42 Modified carbapenem inactivation method (MCIM) Y N

Enter comment
Does the lab perform any genotypic tests for carbapenemase production?
Enter comment
12.43 Y N
(e.g., PCR, GeneXpert, etc.)
Do records indicate that quality control is done each time carbapenemase
Enter comment
12.44 Y N NA
testing is performed?
Enter comment
to QC the carbapenemase test in use?

12.45 Commonly used carbapenemase positive strains include Klebsiella Y N NA
pneumoniae ATCC BAA-1705, K. pneumonaie CCUG 56233, and K.
pneumoniae NCTC 13438
When a carbapenemase producer is detected, is it noted on the final report to
Enter comment
12.46 Y N NA
the clinician?
When a carbapenemase producer is detected, is infection control notified by
Enter comment
12.47 Y N NA
the lab?
COLISTIN TESTING
Question Number
Does the lab perform colistin AST? (Not scored. If No, skip to next section.) Y N
number
Question and
Instructions for 7
Which methods does the lab use for colistin AST? (Select Y for each method place holder place holder
items below.
used)
12.48 Disk diffusion Y N
Enter comment
12.49 Gradient strip (e.g., Etest/Liofilchem) Y N

Enter comment
12.50 Automated instrument (e.g., Vitek/Phoenix) Y N

Enter comment
12.51 Broth microdilution (BMD) with Polysorbate 80 Y N

Enter comment
12.52 Broth microdilution (BMD) without Polysorbate 80 Y N

Enter comment
12.53 Colistin Broth Disk Elution (CBDE) Test Y N

Enter comment
12.54 Agar dilution (Colistin Agar Test) Y N

Enter comment
Do records indicate that quality control for colistin AST is performed on either
Enter comment
12.55 Y N NA
a weekly basis or each time the test is performed?
Do records indicate that lab uses appropriate organisms to QC the colistin test
Enter comment
12.56 in use? (Pseudomonas aeruginosa 27853 AND E. coli NCTC 13846 or E. coli AR Y N NA
Bank #0349).
Question for 3
items below. When colistin resistance is detected, are any of the following notified? place holder place holder
12.57 Lab supervisor Y N NA

Enter comment
12.58 Infectious Disease team Y N NA

Enter comment
12.59 Infection Control team Y N NA

Enter comment
When colistin resistance is detected, is the isolate sent to a reference lab for
Enter comment
12.60 Y N NA
molecular characterization (e.g., testing for mcr genes)?
If the lab uses broth microdilution for colistin AST, is colistin sulfate used, not
Enter comment
colistin methane sulfonate (sulfomethate)?

12.61 Y N NA
The methane sulfonate derivative of colistin ("cms") is an inactive pro-drug
that breaks down slowly in solution and therefore cannot be used for AST.
If the lab performs broth microdilution (BMD) for colistin AST, is cation-
Enter comment
12.62 adjusted Mueller Hinton broth used? Y N NA

Answer NA if the lab does not perform BMD.
Do laboratory staff understand the current limitations associated with colistin
Enter comment
12.63 AST? (i.e., the risk of false susceptible results when using disk diffusion, Y N
gradient strip, or automated methods.)

Question Number
Has the lab educated the medical staff about the current limitations and risks
Enter comment
12.64 Y N
associated with colistin AST?
EXPERT RULES FOR STAPHYLOCOCCUS AUREUS

Question Number
Does the lab test S. aureus isolates against penicillin?
Enter comment
12.65 Y N
If no, answer NA to next question
Are S. aureus isolates with penicillin zones sizes or MICs in the susceptible
Enter comment
12.66 range tested for β-lactamase production using the zone-edge test before being Y N NA
reported as penicillin susceptible?
12.67 Does the lab use oxacillin disks to test for MRSA? Y N
Enter comment
When oxacillin and cefoxitin results are discrepant for S. aureus (one is S and
Enter comment
one is R), how does the lab report oxacillin?

1: Report the oxacillin interpretation, regardless of what the cefoxitin
result is
12.68 1 2 3 NA
2: Report the cefoxitin interpretation, regardless of what the oxacillin
result is
3: If either drug tests R, report the result as R
NA: the lab only tests one of these drugs, not both
Does the lab perform S. aureus AST on any beta-lactam antibiotics other than
Enter comment
12.69 Y N
penicillin, oxacillin, cefoxitin, or ceftaroline?
12.70 Does the lab use vancomycin disks to test for VISA/VRSA? Y N
Enter comment
When a manual MIC method is used to test vancomycin against Staphylococcus

Enter comment
12.71 aureus, is the test incubated for a full 24 hours before reading the result? Y N NA
Answer NA if manual MIC method not used
When a vancomycin MIC >8 is detected for S. aureus, is the isolate sent to a
Enter comment
12.72 referral lab for confirmation testing and further characterization? Y N NA

Answer NA if vancomycin not tested
Are S. aureus that are resistant to Erythromycin and susceptible or
Enter comment
12.73 Y N
intermediate to Clindamycin tested for inducible clindamycin resistance?
GENERAL CONSIDERATIONS FOR STREPTOCOCCUS PNEUMONIAE

Question Number
Observe a Streptococcus pneumoniae AST plate being read
Instructions for
items below. If lab does not perform disk or Etest for S. pneumoniae AST, select NA for all place holder place holder
answers
12.74 Is the upper surface of the agar read with the cover removed? Y N NA
Enter comment
12.75 Is the plate illuminated adequately with reflected light? Y N NA

Enter comment
Are zones measured where growth is inhibited (as opposed to the zone of
Enter comment
12.76 Y N NA
hemolysis)?
Are there no more than 4 disks per 100mm plate or 9 disks per 150mm
Enter comment
12.77 Y N NA
plate?
If the lab uses an oxacillin disk (1ug) to screen for penicillin resistance in Strep.
Enter comment
pneumoniae, what does the lab’s SOP instruct when the zone size measures
<19? (Referring to penicillin G or Benzylpenicillin, the IV formulation)
12.78 1 2 NA
1: Report penicillin resistant
2: Perform additional testing using a penicillin MIC method
NA: lab does not perform oxacillin screen
EXPERT RULES FOR STREPTOCOCCUS PNEUMONIAE

Question Number
Does the lab perform AST for S. pneumoniae? (Not scored. If No, skip to next
No question
Y N Enter comment
section.)
number
Question for 10 Does the lab use the disk diffusion method to test any of the following place holder place holder
antibiotics against S. pneumonaie?

items below.
12.79 Penicillin Y N NA
Enter comment

Question Number
12.80 Amoxicillin Y N NA
Enter comment
12.81 Ampicillin Y N NA
Enter comment
12.82 Cefotaxime Y N NA
Enter comment
12.83 Ceftriaxone Y N NA
Enter comment
12.84 Cefuroxime Y N NA
Enter comment
12.85 Cefepime Y N NA
Enter comment
12.86 Ertapenem Y N NA
Enter comment
12.87 Meropenem Y N NA
Enter comment
12.88 Imipenem Y N NA
Enter comment
Question for 2 When S. pneumoniae is isolated from blood or cerebrospinal fluid, does the lab place holder place holder
test the following antibiotics using an MIC method?

items below.
12.89 Penicillin Y N NA
Enter comment
12.90 Ceftriaxone and/or Cefotaxime Y N NA

Enter comment
When S. pneumoniae is isolated from CSF, are penicillin, ceftriaxone, and/or

Enter comment
12.91 Y N NA
cefotaxime reported using the meningitis breakpoints only?
When S. pneumoniae is isolated from specimens other than CSF, are penicillin,
Enter comment
12.92 ceftriaxone, and/or cefotaxime reported using both meningitis and non- Y N NA
meningitis breakpoints?
Are S. pneumoniae that are resistant to Erythromycin and susceptible or
Enter comment
12.93 Y N NA
intermediate to Clindamycin tested for inducible clindamycin resistance?
INDUCIBLE CLINDAMYCIN RESISTANCE TESTING

Question Number
Does the lab perform the test for Inducible Clindamycin Resistance (ICR), also
Enter comment
12.94 known as the “D-test” on Staphylococcus aureus and/or Streptococcus Y N

pneumoniae?
Does the SOP for the ICR test specify that the erythromycin and clindamycin
Enter comment
12.95 Y N NA
disks must be placed 15-26 mm apart for Staphylococcus species?
Does the SOP for the ICR test specify that the erythromycin and clindamycin
Enter comment
12.96 Y N NA
disks must be placed 12 mm apart for Streptococcus species?
Do records indicate that quality control for ICR testing is done either on a
Enter comment
12.97 Y N NA
weekly basis or each time the test is performed?
Enter comment
12.98 to QC the ICR test in use? (Commonly used ICR positive strain is S. aureus ATCC Y N NA
BAA-977)
12.99 When the ICR test is positive, is the clindamycin result changed to resistant? Y N NA
Enter comment
EXPERT RULES FOR CEREBROSPINAL FLUID (CSF)

Question Number
Review a patient AST report for a positive CSF culture. Were any of the
Question and
Instructions for 8
following drug classes tested or reported? place holder place holder
items below.
(These are not the drugs of choice and may not be effective for treating CSF
infections, regardless of the AST result)
1st generation cephalosporins (cefazolin, cephalothin, cephapirin,
Enter comment
12.100 Y N NA
cephadrine)
12.101 2nd generation cephalosporins (cefuroxime, cefonicid, cefamandole) Y N NA
Enter comment
12.102 Cephamycins (cefoxitin, cefotetan) Y N NA

Enter comment
12.103 Clindamycin Y N NA
Enter comment
12.104 Macrolides (Erythromycin, Azithromycin, Clarithromycin) Y N NA

Enter comment
12.105 Tetracyclines (Tetracycline, Minocycline, Doxycycline) Y N NA

Enter comment
12.106 Fluoroquinolones (Ciprofloxacin, Levofloxacin, Moxifloxacin) Y N NA

Enter comment
12.107 Nitrofurantoin Y N NA
Enter comment

13- AST PANELS, POLICY & ANALYSIS
AST PANELS
Question Number
Is there an SOP that clearly defines the standard combination of antibiotics
Question and
Instructions for 7
items below.
("antibiotic panels") the lab will test against each of the following pathogens? place holder place holder
(CLSI and EUCAST documents are not SOPs)

13.1 Staphylococcus aureus Y N
Enter comment
13.2 Enterococcus spp Y N

Enter comment
13.3 Streptococcus pneumoniae Y N

Enter comment
13.4 Enterobacteriaceae Y N
Enter comment
13.5 Salmonella spp Y N

Enter comment
13.6 Acinetobacter spp Y N

Enter comment
13.7 Pseudomonas aeruginosa Y N

Enter comment
Review several patient AST reports for E. coli. Is the same combination of
Enter comment
13.8 Y N
antibiotics tested each time?
Does the SOP clearly define how to modify the standard antibiotic panels
Instructions for
items below. described above based upon the body site of infection? ONLY select NA if the place holder place holder
laboratory does not perform testing on the body site listed.

13.9 Urine Y N NA
Enter comment
13.10 CSF Y N NA
Enter comment
13.11 Blood Y N NA
Enter comment
CUMULATIVE ANTIBIOGRAMS
Question Number
13.12 Does the lab produce a cumulative antibiogram at least annually? Y N
Enter comment
13.13 Does the lab have a software program to produce the antibiogram? Y N NA
Enter comment
Question and
Instructions for
Review the most recent cumulative antibiogram. Does it adhere to the place holder place holder
items below.
following CLSI M39 recommendations?
13.14 Clearly displays the inclusive date range (e.g. Jan 1, YYYY – Dec 31, YYYY) Y N NA
Enter comment
13.15 Clearly displays the name of the hospital/facility Y N NA

Enter comment
13.16 Data is presented as %S (not %R) Y N NA

Enter comment
13.17 For each organism, the total N tested is displayed Y N NA

Enter comment
Only presents data for organisms/antibiotics where the total N = 30 or more

Enter comment
13.18 Y N NA
isolates
Are isolates from environmental cultures and screening cultures (e.g., MRSA
Enter comment
13.19 Y N NA
screen, VRE screen) excluded from the analysis?
Is the lab able to de-duplicate the data, so that only the first isolate of a given
Enter comment
13.20 species per patient, per analysis period is included, irrespective of the body site Y N NA
of recovery?
13.21 Is the lab able to separate Inpatient data from outpatient data? Y N NA
Enter comment
If the lab serves multiple hospitals/facilities, are they able to separate the data
Enter comment
13.22 Y N NA
by Facility?
Is the cumulative antibiogram reviewed annually by either an Antibiotic
Enter comment
13.23 Y N NA
Stewardship or a Pharmacy & Therapeutics Committee?
13.24 Is the cumulative antibiogram distributed to all physicians? Y N NA
Enter comment
AST POLICY
Question Number
Does lab policy primarily determine which isolates receive AST, or is AST
Enter comment
performed only when it is specifically requested by the doctor?

13.25 1: Lab policy primarily determines 1 2 3
2: Only when requested by clinician
3: Equal mix of both

Question Number
Does lab policy primarily determine which antibiotics to test and report, or
Enter comment
does the lab only test and report the antibiotics specifically requested by the
physician?
13.26 1 2 3
1: Lab policy primarily determines
2: Only the antibiotics requested by physician
3: Equal mix of both
"Cascade reporting” is a strategy of selective reporting of AST results in which
Instructions for secondary agents (e.g., broader spectrum, more costly) may be suppressed or place holder place holder
excluded from the patient report if an organism is susceptible to primary

items below.
agents within the same drug class.

Does the lab practice “cascade reporting”?
Enter comment
13.27 Y N
If no, answer NA to next question
With cascade reporting, there is a risk that the AST results excluded from the
Instructions for patient report may also be excluded from the main data repository or LIS. This place holder place holder
can lead to highly biased AMR surveillance and cumulative antibiogram

items below.
statistics.
If the lab practices cascade reporting, is it done in a way which ensures that
Enter comment
13.28 the AST results excluded from the patient report are NOT excluded from the Y N NA
LIS or other main data repository?
13.29 Does the hospital have an Antibiotic Stewardship Committee? Y N NA
Enter comment
If the hospital has an Antibiotic Stewardship Committee, is a microbiologist a

Enter comment
13.30 Y N NA
member?
13.31 Does the hospital have a Pharmacy and Therapeutics Committee? Y N NA
Enter comment
If the hospital has a Pharmacy and Therapeutics Committee, is a microbiologist

Enter comment
13.32 Y N NA
a member?
Does the hospital's Antibiotic Stewardship or Pharmacy and Therapeutic
Enter comment
Committee meet at least annually to review national or international AST panel

13.33 Y N NA
recommendations and modify them based on the hospital's formulary and
cumulative antibiogram?

SAFETY
To be completed if there is no record of another safety audit in the past 12 months. This is not intended to be a
comprehensive safety audit.
BIOSAFETY EQUIPMENT
Question Number
Question for
items below. Is standard safety equipment available and in use in the laboratory? place holder place holder
SA1 Biosafety cabinets (Class IIA) Y N

Enter comment
SA2 Covers on each centrifuge bucket Y N

Enter comment
SA3 Cover over centrifuge rotor Y N

Enter comment
SA4 Hand-washing station Y N

Enter comment
SA5 Eyewash station/bottle Y N

Enter comment
SA6 Sharps containers Y N

Enter comment
SA7 Flame cabinet (for securely storing flammable liquids, e.g. ethanol) Y N
Enter comment
SA8 Spill kit Y N

Enter comment
SA9 First aid kit Y N

Enter comment
Standard: It is the responsibility of laboratory management to ensure the

laboratory is equipped with standard safety equipment. The list above is a
partial list of necessary items. Biosafety cabinets should be in place and in
use and all centrifuges should have covers. Hand washing stations should be
designated and equipped and eyewash stations (or an acceptable alternative
method of eye cleansing) should be available and operable. Spill kits and first
2 Standards for
item above. aid kits should be kept in a designated place and checked regularly for place holder place holder
readiness.
Standard: ISO 15189: 5.2.10: All syringes, needles, lancets, or other
bloodletting devices capable of transmitting infection must be used only
once and discarded in puncture resistant containers that are not overfilled.
Sharps containers should be clearly marked to warn handlers of the potential
hazard and should be located in areas where sharps are commonly used.
SA10 Have all biosafety cabinets been recertified within a year of today’s date? Y N
Enter comment
Standard: A biosafety cabinet should be used for to prevent aerosol exposure

Standard for item to contagious specimens or organisms. For proper functioning and full place holder place holder
protection, biosafety cabinets require periodic maintenance and should be

above.
serviced accordingly.
PERSONAL PROTECTIVE EQUIPMENT
Question Number
Question for 4
items below. Is all necessary personal protective equipment (PPE) available for BSL2? place holder place holder
SA11 Gowns Y N
Enter comment
SA12 Gloves Y N
Enter comment
SA13 Eye protection Y N

Enter comment
SA14 Aerosol face protection (respirator, face shield, or splatter guard) Y N

Enter comment
SA15 Does lab policy require microbiology staff to wear close-toed shoes? Y N
Enter comment
Is PPE utilized appropriately and consistently by laboratory staff? (Observe)

Enter comment
1: Yes
SA16 123
2: Partial
3: No
Standard: Management is responsible to provide appropriate personal
protective equipment — gloves, lab coats, eye protection, shields, etc. — in
Standard for item useable condition. Laboratory staff must utilize personal protective place holder place holder
equipment in the laboratory at all times. Protective clothing should not be

above.
worn outside the laboratory. Gloves should be replaced immediately when

torn or contaminated and not washed for reuse.

BIOSAFETY BEHAVIORS
Question Number
SA17 Does lab policy prohibit eating, drinking, and smoking in the laboratory? Y N
Enter comment
Question for 4 Observe the refrigerators and freezers where media and reagents are stored. place holder place holder
Are they:
items below.
SA18 Designated specifically for storage of media/reagents? Y N

Enter comment
SA19 Free of staff food items? Y N

Enter comment
SA20 Free of patient samples? Y N

Enter comment
SA21 Well organized and free of clutter? Y N

Enter comment
Are all hazardous chemicals stored appropriately (acids separate from alkaline;
Enter comment
SA22 Y N
flammables in a flame cabinet)?
SA23 Is work area (bench and hood) disinfection documented daily? Y N
Enter comment
Standard: ISO 15189: 5.2.10 The work area should be regularly inspected for
cleanliness and leakage. An appropriate disinfectant should be used. At a
Standard for item
above. minimum, all benchtops and working surfaces should be disinfected at the place holder place holder
beginning and end of every shift. All spills should be contained immediately,
and the work surfaces disinfected.
BIOSAFETY DOCUMENTATION AND TRAINING
Question Number
Is a safety/biosafety manual available in the laboratory and easily accessible to
Enter comment
SA24 Y N
all staff?
SA25 Is a training module in safety/biosafety available in the laboratory? Y N
Enter comment
Is there documentation demonstrating that an annual safety/biosafety

Enter comment
SA26 refresher course is conducted for all staff handling specimens, isolates, or Y N
chemicals?
Is there documentation demonstrating that accident/incident investigations
Enter comment
SA27 Y N
are systematically conducted?
Are risk assessments conducted annually and each time a new
Enter comment
SA28 Y N
analysis/technology/equipment is introduced?

LAARC User’s Manual and Questionnaire
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Laboratory Assessment of Antibiotic

Resistance Testing Capacity

Division of Healthcare Quality Promotion

U.S. Centers for Disease Control and Prevention

National Center for Emerging and Zoonotic Infectious Diseases

Division of Healthcare Quality Promotion

Photo Credit: Daniella Coker

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TABLES AND FIGURES

Figure 1: Module architecture and organization..................................................................................................... 15

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The specimen types, organisms and antibiotics

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Table 1: GLASS priority specimens and pathogens for surveillance of AR

1 Laboratory Assessment Questionnaire for Antimicrobial Resistance Testing (https://extranet.who.int/dataform/549586?lang=en)

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2. ASSESSMENT PLANNING and PREPARATION

2.1 Assessment Team

2.2 Team Preparation

Useful (but not required) items include:

2.3 Laboratory Preparation

2.4 Assessment Process

2.4.2. Meet with staff

2.4.3 Tour the laboratory

• Patient reception/sampling rooms (if the laboratory collects specimens)

2.4.4 Review Documents and Fill the Questionnaire

Documentation is key. Confirm answers whenever possible by reviewing the supporting

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3.2 Excel File Organization

3.2.1 Yellow (5 tabs)

• Cover: Cover page

3.2.2 Blue: Questionnaire (15 tabs)

Table 4: LAARC Questionnaire Modules

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3.2.3 Questionnaire Organization and Structure

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Table 5: Description of Module Structure

3.2.4. Red (5 tabs)

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4.1 Generate a Unique Filename

4.2 Select Language

4.3 Answer Questions

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4.3.2 Fee-text cells and Comment cells

4.3.3 Color Coding

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5.2 Indicators and Modules

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6. RESULTS: SUMMARY, FLAGS, CONCLUSION and PHOTOS

6.1 Summary tab

6.2 Flag tab

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6.3 Conclusion tab

6.4 Photograph tab