Download Document

www.wslhpt.org
2601 Agriculture Drive  Madison, WI 53718  (800) 462-5261  (608) 265-1111
2015-BactiReg2 Event Notes
Shipment Date: June 15, 2015
Questions or comments should be directed to Amanda Weiss at 800-462-5261 x51 or [email protected].
Important Information:
PT –Central Updates: Enhancements will continue to be added throughout 2015.
 90% of participants are reporting results online at PT-Central. Thank you!
 General instructions are located online at www.wslhpt.org .
 Event Name now appears on your home page next to result entry.
 Single SAVE function with results editable until the due date.
 Data submission report now contains attestation signature.
Result form and Report Delivery options: The settings for your facility are noted in the demographic information in the
upper right corner of your PT Central home page.
 Results can be entered online or by fax. Online data entry is encouraged. If the data entry option is set to “web,”
paper result forms will not be sent with your PT sample shipments.
 The Report Delivery option is set to Email attachment, Email notification, or Paper. Paper reports will only be
mailed to facilities that are not set up to receive emails.
 Please notify us at [email protected] or use the “Contact Us” option on the website if you wish to change
your data entry or report settings.
Specific Sample Notes:
Module
Page(s)
5090 Gram Stain (GS)
3
5030 Bacteriology Comprehensive (MCP)
4-7
5040 Bacteriology Limited (MCL)
4-7
5250 Throat / Urine Bacteriology (TU)
8 - 10
5260 Throat / Urine Bacteriology Limited (TUL)
8 - 10
5270 Urine Culture (UC)
11 -15
5080 Enteric Pathogens Culture (NP)
16- 19
Mark Your Calendars Now! Next Event Ships: September 14, 2015
Page 1 of 19
2015-BactiReg2
Event Notes
Please review your reports carefully before filing with the rest of your PT records. Documentation of all decisions and
actions concerning incorrect responses should be maintained with your event reports to satisfy regulatory requirements.
After trouble-shooting or corrective actions are completed and documented, all reports should be reviewed,
signed/initialed by the appropriate personnel, and filed with your proficiency testing records to document your
participation.
Event Specific Information:
Module 5000 (Bacterial Antigens—for meningitis)
BA-12 N. meningitidis Group B/ E. coli K1: This sample contained N. meningitidis Group B. Participant
responses did not reach the 80% peer consensus requirement and, therefore, results were not scored. Laboratories
must perform a written self-evaluation of their response to document participation for their lab surveyor. Peer
specific data is included in the table below and can be useful for post event troubleshooting and documentation.
BA-10 N. meningitidis Group B/E. coli K1 Participant Results
BD Directigen
Wellcogen
Total
Positive
Negative
3
1
4
10
2
12
According to some kit manufacturers, a heating step may affect the sensitivity for the N. meningitidis Group B/E.
coli K1 antigen. It is important for laboratories to reference their package inserts for proper sample handling prior
to testing.
Module 5220 (Neisseria gonorrhoeae): All samples were not scored due to <10 participants reporting results. All
laboratories must perform a self-evaluation to document participation for their lab surveyors. Statistics can be found
online in the Reports link of your PT-Central account.
For the following modules, all analytes and samples achieved ≥80% peer consensus, matched targets, and were scored
accordingly. Laboratories using methods with peer groups of n<10 were scored by the All Methods group.
Module 5060 (Clostridium difficile)
Module 5070 (CT/GC Detection)
Module 5110 (Group A Strep Antigen)
Module 5160 (Group A Strep Antigen/Strep Culture)
Module 5170 (Group A Strep Culture)
Module 5180 (Group B Strep)
Module 5200 (MRSA/VRE)
Module 5280 (Vaginal Pathogens)
Your PT Evaluation Report displays your method peer group and acceptable responses. Statistics are available online
under the Reports link of your PT-Central account.
References
1. Versalovic, J. (ed). 2013. Manual of Clinical Microbiology. 10th ed. ASM Press, Washington, D.C.
Page 2 of 19
2015-BactiReg2
Event Notes
Module 5090 (Gram Stain)
Gram Stain Organisms & Target Responses
Sample
GS-6
GS-7
GS-8
GS-9
GS-10
Sample Contents
Staphylococcus aureus
Fusobacterium nucleatum
Neisseria gonorrhoeae
Pseudomonas aeruginosa
Streptococcus pneumoniae
Gram Reaction
Gram positive
Gram negative
Gram negative
Gram negative
Gram positive
Target Morphology
Cocci
Rods/bacilli
Diplococci
Rods/bacilli
Diplococci
Gram Stain Referee and Participant Results
100%
Gram positive
Gram negative *
Cocci
Participant
No.
%
71
99
1
1
71
100
Gram reaction
Morphology
100%
100%
Gram negative
Rods/bacilli
72
100
100
100
GS-8
Gram reaction
Morphology
100%
100%
Gram negative
Diplococci
Cocci
Coccobacilli *
72
61
9
1
100
86
13
1
GS-9
Gram reaction
100%
Morphology
67% ^
Gram negative
Gram positive *
Rods/bacilli
Coccobacilli
Diplococci
Cocci
68
3
48
18
2
2
96
4
69
26
3
3
Gram reaction
76% ^
Morphology
62% ^
Gram positive
Gram negative
Diplococci
Cocci
Coccobacilli
Rods/bacilli
56
15
24
25
15
6
79
21
34
36
21
9
Sample
Analyte
GS-6
Gram reaction
Referee
Consensus
100%
Morphology
GS-7
GS-10
Response
* Incorrect response
^Scoring Note: Referee laboratory responses did not reach the 80% consensus requirement and, therefore, results
were not scored. Participants received a 100% non-consensus score, and laboratories must perform a written selfevaluation of their response to document participation for their lab surveyor.
Sample GS-10 (S. pneumoniae) Note: Technologists should strive to report an interpretation of what is presented
on the Gram stain, rather than simply report what is seen. Several participants reported Gram positive coccobacilli,
which if reported on a patient would not indicate to the physician what organism may be present. Conversely,
reporting Gram positive diplococci (or cocci in pairs) on a patient specimen, would give an early clue of what the
organism may be.
Page 3 of 19
2015-BactiReg2
Event Notes
Modules 5030 and 5040 (Bacteriology—Comprehensive and Bacteriology—Limited)
Sample
ID
Requested Procedure/Analyte(s)
Target Organism/Result
Negative for Group A streptococcus antigen
Group A streptococcus antigen
Positive for Group A streptococcus
Group A streptococcus screen
Neisseria gonorrhoeae screen
Positive for Neisseria gonorrhoeae
Leuconostoc sp.
Aerobic blood culture
Gram positive cocci
Gram stain
MC-14
Urine culture
Escherichia coli
Gram negative rods/bacilli
Gram stain
Susceptibility testing
Appropriate antimicrobials & susceptibilities
C. difficile antigen detection
Positive for C. difficile antigen
MC-15
C. difficile toxin detection
Positive for C. difficile toxin
Positive for MRSA
MC-16
MRSA screen
Negative for VRE
VRE screen
Positive for Group B streptococcus
MC-17
Group B streptococcus screen
MC-18
Stool Culture
Campylobacter jejuni
Please note: Samples MC-15 through MC-18 are not included in module 5040 (Bacteriology Limited).
MC-10
MC-11
MC-12
MC-13
MC-10 (Group A streptococcus antigen detection), MC-11 (Group A streptococcus culture), and MC-12 (Neisseria
gonorrhoeae screen): All analytes and samples achieved ≥80% peer consensus, matched targets, and were scored
accordingly. Laboratories using methods with peer groups of n<10 were scored by the All Methods group.
MC-13 (Aerobic blood culture): Sample contained Leuconostoc species >100,000 CFU/Loop.
Referee consensus: Culture = 19% ^
Gram reaction = N/A
Gram morphology = N/A
Primary Organism Responses
Leuconostoc species
Gram positive cocci
Growth observed (would refer)
Growth
No Growth
Staphylococcus epidermidis group
Staphylococcus coagulase negative
Gram positive
Gram negative
Participants
No.
%
26
96
1
4
Cocci
Diplococci
25
1
Gram Stain Responses
Page 4 of 19
2015-BactiReg2
Event Notes
Participants
No.
%
1
<2
4
6
7
11
1
<2
48
75
2
3
1
<2
96
4
^Scoring Note: Referee laboratory responses did not reach the 80% consensus requirement and, therefore, results
were not scored. Participants received a 100% non-consensus score, and laboratories must perform a written selfevaluation of their response to document participation for their lab surveyor.
Many labs (75%) observed “No growth” for this sample both on conventional agar plates and in blood culture
bottles. One participant reported obtaining growth only in a thioglycollate broth. It is unclear why the strain in
sample MC-13 failed to grow for most labs.
Typically, Leuconostoc species do not require any special media and will grow as small alpha-hemolytic or nonhemolytic colonies on blood agar.
Leuconostoc species are Gram positive cocci, typically presenting as pairs or chains. Leuconostoc species are
catalase negative, PYR and LAP negative, and resistant to vancomycin. Leuconostoc species have been reported as
the causal agents in bacteremia, brain abscesses, peritoneal fluid infections and wounds.
MC-14 (Urine culture): Sample contained Escherichia coli >1,000,000 CFU/Loop and Lactobacillus species <10,000
CFU/Loop.
Referee consensus: Culture = 100%
Gram reaction = 100%
Gram morphology = 96%
Primary Organism Responses
Escherichia coli
Gram negative rod/bacilli
Gram negative bacteria
Growth observed (would refer)
Growth
Participants
No.
%
85
1
100
1
15
26
Gram negative
Participants
No.
%
95
100
Rods/bacilli
Coccobacilli *
91
4
Gram Stain Responses
96
4
* Incorrect response
MC-15 (Clostridium difficile toxin/antigen), MC-16 (MRSA/VRE screen), and MC-17 (Group B streptococcus screen):
All analytes and samples achieved ≥80% consensus, matched targets, and were scored accordingly. Laboratories using
methods with peer groups of n<10 were scored by the All Methods group.
MC-16 Scoring Note (MRSA screen): This sample contained methicillin resistant Staphylococcus aureus (MRSA)
and methicillin sensitive S. aureus (MSSA). The MRSA was detected by 81% of participants.
Colonies of MRSA and MSSA may appear as different morphologies on routine media. When PT samples or patient
specimens grow multiple morphologies of S. aureus, all colony types should be screened for methicillin resistance.
Page 5 of 19
2015-BactiReg2
Event Notes
MC-18 (Stool for enteric pathogens): Sample contained Campylobacter jejuni >1,000,000 CFU/Loop and Klebsiella
pneumoniae >100,000 CFU/Loop.
Aeromonas
Campylobacter
Referee
Consensus
100%
100%
E. coli O157:H7
100%
Plesiomonas
Salmonella
100%
100%
Shigella
100%
Vibrio
Yersinia
100%
100%
Organism
Participant Responses
Not identified in stool
Campylobacter jejuni
Campylobacter species
Positive by Immunoassay
Not identified in stool *
Not identified in stool
Not detected
Normal Flora isolated ^
Not identified in stool
Not identified in stool
Normal Flora isolated ^
Not identified in stool
Normal Flora isolated ^
Not identified in stool
No identified in stool
No. of
Participants
36
10
26
12
2
47
1
1
34
55
1
55
1
27
32
* Incorrect response
^ This response was not scored
Antimicrobial Susceptibility Testing (AST) Notes
General AST Notes:
Per the Centers for Medicare & Medicaid Services (CMS) requirements, all reported antimicrobials were scored using the
CLSI M100-S25 (January 2015) document. AST scores were reduced, per CLIA regulations, for reporting inappropriate
antimicrobials.
Certain antimicrobials, interpretations, zone sizes, and/or minimum inhibitory concentration (MIC) values were not
scored. There was no deduction from participants’ scores for these responses; however, a written self-evaluation of your
response must be performed to document participation for accrediting agencies.
Participants reporting MIC values or zone sizes must give both a correct/appropriate MIC or zone size and a correct
interpretation in order to receive a passing result for that antimicrobial.
For example, if according to the CLSI M100 document, an MIC of 2 for ciprofloxacin should be interpreted as
“intermediate,” and a participant reported an MIC of 2 and an interpretation of “susceptible” for ciprofloxacin, that
antimicrobial would receive a 0%.
If you have an AST result that is marked as unsatisfactory on your Evaluation Report even though your interpretation
matches the accepted result, it is most likely due to an incorrect MIC or zone size response. Accepted MIC and zone size
responses are not shown on your Evaluation Report. Please refer to your CLSI M100-S25 document for antimicrobial
agents and their appropriate MIC values and zone sizes.
Any time a laboratory is reporting an antimicrobial agent or interpretation that does not correspond to the current version
of the CLSI M100 document because of in-house protocols, it should be documented in the “Comments” section of your
results.
Page 6 of 19
2015-BactiReg2
Event Notes
Sample Specific Notes: MC-14 (E. coli in urine)
CLSI and FDA Breakpoint Discrepancies:
The FDA breakpoints for aztreonam, cefotetan, ceftriaxone, ertapenem, imipenem, and meropenem have been revised to
coincide with the current CLSI breakpoints. Information for many antimicrobials, including current FDA breakpoints,
can be found at http://www.accessdata.fda.gov/scripts/cder/drugsatfda/.
The manufacturers of automated susceptibility systems such as Microscan, Phoenix, and Vitek are required to follow FDA
guidelines when setting MIC breakpoints for their automated systems. Some automated systems may be incapable of
producing low enough MIC values to accurately follow the current guidelines. Laboratories using these systems must
comment on any measures being taken to update susceptibility testing to the current guidelines.
Currently, cefotaxime is the only antimicrobial reported on this sample that has a CLSI-FDA breakpoint discrepancy.
Laboratories that reported an MIC value that follows FDA cefotaxime breakpoints were “Not Scored” if a comment was
submitted informing WSLH PT that FDA guidelines were being followed.
CLSI/FDA MIC Breakpoint Discrepancy
Antimicrobial Agent
Cefotaxime
CLSI M100-S25
MIC Breakpoints
(µg/mL)
S
I
R
≤1
2
≥4
FDA Breakpoints
(µg/mL)
S
I
R
≤8
16-32
≥ 64
Not Scored Antimicrobials:
The current version of the CLSI-M100 document now has a “susceptible – dose dependent” (SDD) interpretive category.
Cefepime is the only antimicrobial in Table 2A, Enterobacteriaceae that has SDD breakpoints. MIC values in the SDD
breakpoint range were not scored.
The following antimicrobials were not scored due to less than 10 laboratories reporting results: cefdinir, cefixime,
cefotetan, cefuroxime-sodium (parenteral), cephalothin, doripenem, fosfomycin, moxifloxacin, norfloxacin, piperacillin,
ticarcillin/clavulanate, and trimethoprim.
Inappropriate Antimicrobials:
Appropriate antimicrobials for E. coli are listed in Table 2A, Enterobacteriaceae, of the CLSI M100-S25 document.
Antimicrobials that are considered inappropriate according to this table received a 0% score. Laboratories reporting
inappropriate antimicrobials are encouraged to review their susceptibility protocols and only report clinically relevant
agents based on organism and specimen source.
Page 7 of 19
2015-BactiReg2
Event Notes
Modules 5250 and 5260 (Throat/Urine Bacteriology and Throat/Urine Bacteriology—Limited)
Sample ID
Requested Procedure/Analyte(s)
Primary Target Organism/Result
TU-8
TU-9
Urine culture
Aerococcus urinae
No growth
Urine culture
Urine culture
Escherichia coli
Gram negative rod/bacilli
TU-10
Gram stain
Susceptibility testing
Appropriate antimicrobials & susceptibilities
Negative for Group A streptococcus
TU-11
Group A streptococcus culture
Positive for Group A streptococcus
TU-12
Group A streptococcus culture
Negative for Group A streptococcus antigen
TU-13
Group A streptococcus antigen
Negative for Group A streptococcus antigen
TU-14
Group A streptococcus antigen
Please note: Samples TU-13 and TU-14 are not included in the Throat/Urine Bacteriology--Limited (5260) module.
TU-8 (Urine culture): Sample contained Aerococcus urinae >1,000,000 CFU/Loop.
Referee consensus = 83%
Primary Organism Responses
Aerococcus species
Gram positive cocci
Gram positive bacteria
Growth observed (would refer)
Growth
No growth *
Participants
No.
%
1
2
56
3
9
13
44
22
* Incorrect response
Sample Note: A. urinae has been implicated as a urinary tract pathogen in patients predisposed to infection. The
organism forms small alpha-hemolytic, grey colonies on blood agar media. A. urinae is catalase negative and
typically presents as clusters on a wet mount or Gram stain.
TU-9 (Urine culture): Sample contained no organisms.
Referee consensus = 91%
Primary Organism Responses
No growth
Growth observed (would refer) *
Growth *
* Incorrect response
Page 8 of 19
2015-BactiReg2
Event Notes
Participants
No.
%
88
44
1
12
5
TU-10 (Urine culture): Sample contained Escherichia coli >1,000,000 CFU/Loop and Lactobacillus species <10,000
CFU/Loop.
Referee consensus: Culture = 100%
Gram reaction = 100%
Gram morphology = 96%
Primary Organism Responses
Escherichia coli
Gram negative rod/bacilli
Gram negative bacteria
Growth observed (would refer)
Growth
Participants
No.
%
85
1
100
1
15
26
Gram negative
Participants
No.
%
95
100
Rods/bacilli
Coccobacilli *
91
4
Gram Stain Responses
96
4
* Incorrect response
TU-11 and TU-12 (Group A streptococcus culture) and TU-13 and TU-14 (Group A streptococcus antigen detection):
All samples and analytes achieved ≥80% peer consensus, matched targets, and were scored accordingly. Laboratories
using methods with peer groups of n<10 were scored by the All Methods group.
Antimicrobial Susceptibility Testing (AST) Notes
General AST Notes:
Per the Centers for Medicare & Medicaid Services (CMS) requirements, all reported antimicrobials were scored using the
CLSI M100-S25 (January 2015) document. AST scores were reduced, per CLIA regulations, for reporting inappropriate
antimicrobials.
Certain antimicrobials, interpretations, zone sizes, and/or minimum inhibitory concentration (MIC) values were not
scored. There was no deduction from participants’ scores for these responses; however, a written self-evaluation of your
response must be performed to document participation for accrediting agencies.
Participants reporting MIC values or zone sizes must give both a correct/appropriate MIC or zone size and a correct
interpretation in order to receive a passing result for that antimicrobial.
For example, if according to the CLSI M100 document, an MIC of 2 for ciprofloxacin should be interpreted as
“intermediate,” and a participant reported an MIC of 2 and an interpretation of “susceptible” for ciprofloxacin, that
antimicrobial would receive a 0%.
If you have an AST result that is marked as unsatisfactory on your Evaluation Report even though your interpretation
matches the accepted result, it is most likely due to an incorrect MIC or zone size response. Accepted MIC and zone size
Page 9 of 19
2015-BactiReg2
Event Notes
responses are not shown on your Evaluation Report. Please refer to your CLSI M100-S25 document for antimicrobial
agents and their appropriate MIC values and zone sizes.
Any time a laboratory is reporting an antimicrobial agent or interpretation that does not correspond to the current version
of the CLSI M100 document because of in-house protocols, it should be documented in the “Comments” section of your
results.
Sample Specific Notes: TU-10 (E. coli in urine)
CLSI and FDA Breakpoint Discrepancies:
The FDA breakpoints for aztreonam, cefotetan, ceftriaxone, ertapenem, imipenem, and meropenem have been revised to
coincide with the current CLSI breakpoints. Information for many antimicrobials, including current FDA breakpoints,
can be found at http://www.accessdata.fda.gov/scripts/cder/drugsatfda/.
The manufacturers of automated susceptibility systems such as Microscan, Phoenix, and Vitek are required to follow FDA
guidelines when setting MIC breakpoints for their automated systems. Some automated systems may be incapable of
producing low enough MIC values to accurately follow the current guidelines. Laboratories using these systems must
comment on any measures being taken to update susceptibility testing to the current guidelines.
Currently, cefotaxime is the only antimicrobial reported on this sample that has a CLSI-FDA breakpoint discrepancy.
Laboratories that reported an MIC value that follows FDA cefotaxime breakpoints were “Not Scored” if a comment was
submitted informing WSLH PT that FDA guidelines were being followed.
CLSI/FDA MIC Breakpoint Discrepancy
Antimicrobial Agent
Cefotaxime
CLSI M100-S25
MIC Breakpoints
(µg/mL)
S
I
R
≤1
2
≥4
FDA Breakpoints
(µg/mL)
S
I
R
≤8
16-32
≥ 64
Not Scored Antimicrobials:
The current version of the CLSI-M100 document now has a “susceptible – dose dependent” (SDD) interpretive category.
Cefepime is the only antimicrobial in Table 2A, Enterobacteriaceae that has SDD breakpoints. MIC values in the SDD
breakpoint range were not scored.
The following antimicrobials were not scored due to less than 10 laboratories reporting results: cefdinir, cefixime,
cefotetan, cefuroxime-sodium (parenteral), cephalothin, doripenem, fosfomycin, moxifloxacin, norfloxacin, piperacillin,
ticarcillin/clavulanate, and trimethoprim.
Inappropriate Antimicrobials:
Appropriate antimicrobials for E. coli are listed in Table 2A, Enterobacteriaceae, of the CLSI M100-S25 document.
Antimicrobials that are considered inappropriate according to this table received a 0% score. Laboratories reporting
inappropriate antimicrobials are encouraged to review their susceptibility protocols and only report clinically relevant
agents based on organism and specimen source.
Page 10 of 19
2015-BactiReg2
Event Notes
Module 5270 (Urine culture)
Sample ID
UC-6
UC-7
UC-8
UC-9
UC-10
Requested
Procedure/Analyte(s)
Target Organism/Result
Urine culture
Gram stain
Urine culture
Gram stain
Urine culture
Urine culture
Gram stain
Urine culture
Gram stain
Susceptibility testing
Klebsiella pneumoniae
Gram negative rods/bacilli
Aerococcus urinae
Gram positive cocci
No growth
Candida albicans
Gram positive yeast
Escherichia coli
Gram negative rods/bacilli
Appropriate antimicrobials & susceptibilities
Scoring Note: The Gram stain portion of samples UC-6, UC-7 and UC-9 was “Not Scored” since less than 10 participant
laboratories performed this testing. All participants received a 100% score for the Gram stain portion of these samples
and must perform a written self-evaluation of their responses to document participation for their lab surveyor.
Gram Stain Note: Please note that the Gram stain portion of these samples is meant to demonstrate a laboratory’s ability
to perform and read Gram stains. Even if a Gram stain was not required to identify a certain organism in a urine culture
challenge, it is to the laboratory’s advantage to use these samples to show proficiency in Gram staining if it is a procedure
being performed in the facility. Please contact the coordinator at 800-462-5261 x51 with any questions.
UC-6: Sample contained Klebsiella pneumoniae >100,000 CFU/Loop and Lactobacillus sp. <10,000 CFU/Loop.
Peer consensus (Culture) = 93%
Scoring Note: Less than 10 referee laboratories submitted results for this sample; therefore, it was scored by peer
consensus.
Primary Organism Responses
Klebsiella pneumoniae
Klebsiella species
Growth observed (would refer)
Growth
Enterobacter species *
Participants
No.
%
4
1
93
3
6
7
1
* Incorrect response
Gram Stain Responses
(Not Scored)
Gram negative
Gram positive
Rods/bacilli
4
Page 11 of 19
2015-BactiReg2
Event Notes
Participants
No.
%
4
80
1
20
100
UC-7: Sample contained Aerococcus urinae >1,000,000 CFU/Loop.
Referee consensus = 83%
Primary Organism Responses
Aerococcus species
Gram positive cocci
Gram positive bacteria
Growth observed (would refer)
Growth
No growth *
Participants
No.
%
1
2
56
3
9
13
44
22
* Incorrect response
Gram Stain Responses
(Not Scored)
Gram positive
Gram negative
Cocci
Participants
No.
%
3
75
1
25
3
100
Sample Note: A. urinae has been implicated as a urinary tract pathogen in patients predisposed to infection. The
organism forms small alpha-hemolytic, grey colonies on blood agar media. A. urinae is catalase negative and
typically presents as clusters on a wet mount or Gram stain.
UC-8: Sample contained no organisms.
Referee consensus = 91%
Primary Organism Responses
No growth
Growth observed (would refer) *
Growth *
* Incorrect response
Page 12 of 19
2015-BactiReg2
Event Notes
Participants
No.
%
88
44
1
12
5
UC-9: Sample contained Candida albicans >100,000 CFU/Loop and Corynebacterium species <10,000 CFU/Loop.
Peer consensus (Culture) = 80%
Scoring Note: Less than 10 referee laboratories submitted results for this sample; therefore, it was scored by peer
consensus.
Primary Organism Responses
Candida albicans
Yeast present
Growth observed (would refer)
Growth
Staphylococcus coagulase negative *
Pseudomonas species *
No growth *
Participants
No.
%
1
2
80
4
5
7
1
1
7
1
7
* Incorrect response
Gram Stain Responses
(Not Scored)
Gram positive
Yeast
Cocci
Participants
No.
%
5
100
3
1
75
25
UC-10: Sample contained Escherichia coli >1,000,000 CFU/Loop and Lactobacillus species <10,000 CFU/Loop.
Referee consensus: Culture = 100%
Gram reaction = 100%
Gram morphology = 96%
Primary Organism Responses
Escherichia coli
Gram negative rod/bacilli
Gram negative bacteria
Growth observed (would refer)
Growth
Gram negative
Participants
No.
%
95
100
Rods/bacilli
Coccobacilli *
91
4
Gram Stain Responses
* Incorrect response
Page 13 of 19
2015-BactiReg2
Event Notes
Participants
No.
%
85
1
100
1
15
26
96
4
Antimicrobial Susceptibility Testing (AST) Notes
General AST Notes:
Per the Centers for Medicare & Medicaid Services (CMS) requirements, all reported antimicrobials were scored using the
CLSI M100-S25 (January 2015) document. AST scores were reduced, per CLIA regulations, for reporting inappropriate
antimicrobials.
Certain antimicrobials, interpretations, zone sizes, and/or minimum inhibitory concentration (MIC) values were not
scored. There was no deduction from participants’ scores for these responses; however, a written self-evaluation of your
response must be performed to document participation for accrediting agencies.
Participants reporting MIC values or zone sizes must give both a correct/appropriate MIC or zone size and a correct
interpretation in order to receive a passing result for that antimicrobial.
For example, if according to the CLSI M100 document, an MIC of 2 for ciprofloxacin should be interpreted as
“intermediate,” and a participant reported an MIC of 2 and an interpretation of “susceptible” for ciprofloxacin, that
antimicrobial would receive a 0%.
If you have an AST result that is marked as unsatisfactory on your Evaluation Report even though your interpretation
matches the accepted result, it is most likely due to an incorrect MIC or zone size response. Accepted MIC and zone size
responses are not shown on your Evaluation Report. Please refer to your CLSI M100-S25 document for antimicrobial
agents and their appropriate MIC values and zone sizes.
Any time a laboratory is reporting an antimicrobial agent or interpretation that does not correspond to the current version
of the CLSI M100 document because of in-house protocols, it should be documented in the “Comments” section of your
results.
Sample Specific Notes: UC-10 (E. coli in urine)
CLSI and FDA Breakpoint Discrepancies:
The FDA breakpoints for aztreonam, cefotetan, ceftriaxone, ertapenem, imipenem, and meropenem have been revised to
coincide with the current CLSI breakpoints. Information for many antimicrobials, including current FDA breakpoints,
can be found at http://www.accessdata.fda.gov/scripts/cder/drugsatfda/.
The manufacturers of automated susceptibility systems such as Microscan, Phoenix, and Vitek are required to follow FDA
guidelines when setting MIC breakpoints for their automated systems. Some automated systems may be incapable of
producing low enough MIC values to accurately follow the current guidelines. Laboratories using these systems must
comment on any measures being taken to update susceptibility testing to the current guidelines.
Currently, cefotaxime is the only antimicrobial reported on this sample that has a CLSI-FDA breakpoint discrepancy.
Laboratories that reported an MIC value that follows FDA cefotaxime breakpoints were “Not Scored” if a comment was
submitted informing WSLH PT that FDA guidelines were being followed.
CLSI/FDA MIC Breakpoint Discrepancy
Antimicrobial Agent
Cefotaxime
CLSI M100-S25
MIC Breakpoints
(µg/mL)
S
I
R
≤1
Page 14 of 19
2015-BactiReg2
Event Notes
2
≥4
FDA Breakpoints
(µg/mL)
S
I
R
≤8
16-32
≥ 64
Not Scored Antimicrobials:
The current version of the CLSI-M100 document now has a “susceptible – dose dependent” (SDD) interpretive category.
Cefepime is the only antimicrobial in Table 2A, Enterobacteriaceae that has SDD breakpoints. MIC values in the SDD
breakpoint range were not scored.
The following antimicrobials were not scored due to less than 10 laboratories reporting results: cefdinir, cefixime,
cefotetan, cefuroxime-sodium (parenteral), cephalothin, doripenem, fosfomycin, moxifloxacin, norfloxacin, piperacillin,
ticarcillin/clavulanate, and trimethoprim.
Inappropriate Antimicrobials:
Appropriate antimicrobials for E. coli are listed in Table 2A, Enterobacteriaceae, of the CLSI M100-S25 document.
Antimicrobials that are considered inappropriate according to this table received a 0% score. Laboratories reporting
inappropriate antimicrobials are encouraged to review their susceptibility protocols and only report clinically relevant
agents based on organism and specimen source.
Page 15 of 19
2015-BactiReg2
Event Notes
Module 5080 (Enteric Pathogens)
Sample ID
NP-6
NP-7
NP-8
NP-9
NP-10
Target Organism/Result
Shigella flexneri
Salmonella Javiana
Campylobacter jejuni
Escherichia coli O157:H7
Plesiomonas shigelloides
NP-6: Sample contained Shigella flexneri >100,000 CFU/Loop, Citrobacter freundii >100,000 CFU/Loop and
Escherichia coli >10,000 CFU/Loop.
Aeromonas
Campylobacter
Referee
Consensus
100%
100%
E. coli O157:H7
100%
Plesiomonas
100%
Salmonella
100%
Shigella
100%
Vibrio
100%
Yersinia
100%
Organism
Participant Responses
Not identified in stool
Not identified in stool
Negative by Immunoassay
Not detected
Not identified in stool
Not detected
Not identified in stool
Not detected
Not identified in stool
Not detected
Shigella flexneri
Shigella species
Detected
Not identified in stool
Not detected
Not identified in stool
Not detected
Page 16 of 19
2015-BactiReg2
Event Notes
No. of
Participants
31
31
7
3
39
1
31
1
41
3
30
12
3
34
2
36
2
NP-7: Sample contained Salmonella enterica subspecies enterica serotype Javiana >100,000 CFU/Loop, and
Proteus mirabilis >100,000 CFU/Loop.
Organism
Referee
Consensus
Aeromonas
Campylobacter
100%
100%
E. coli O157:H7
100%
Plesiomonas
100%
Salmonella
100%
Shigella
100%
Vibrio
100%
Yersinia
100%
Participant Responses
Not identified in stool
Not identified in stool
Negative by Immunoassay
Not detected
Not identified in stool
Not detected
Not identified in stool
Not detected
Salmonella Javiana
Salmonella species
Detected
Not identified in stool
Not detected
Not identified in stool
Not detected
Not identified in stool
Not detected
No. of
Participants
31
31
7
3
39
1
31
1
18
24
3
42
3
34
2
36
2
NP-8: Sample contained Campylobacter jejuni >1,000,000 CFU/Loop and Klebsiella pneumoniae >100,000
CFU/Loop.
Aeromonas
Campylobacter
Referee
Consensus
100%
100%
E. coli O157:H7
100%
Plesiomonas
100%
Salmonella
100%
Shigella
100%
Vibrio
100%
Yersinia
100%
Organism
Participant Responses
Not identified in stool
Campylobacter jejuni
Campylobacter species
Positive by Immunoassay
Detected
Not identified in stool
Not detected
Not identified in stool
Not detected
Not identified in stool
Not detected
Not identified in stool
Not detected
Not identified in stool
Not detected
Not identified in stool
Not detected
Page 17 of 19
2015-BactiReg2
Event Notes
No. of
Participants
31
21
10
6
3
39
1
31
1
41
3
42
3
34
2
36
2
NP-9: Sample contained Escherichia coli O157:H7 >100,000 CFU/Loop and Escherichia coli (non-O157:H7) >100,000
CFU/Loop.
Aeromonas
Campylobacter
Referee
Consensus
100%
100%
E. coli O157:H7
100%
Plesiomonas
100%
Salmonella
100%
Shigella
100%
Vibrio
100%
Yersinia
100%
Organism
Participant Responses
Not Identified in stool
Not identified in stool
Negative by Immunoassay
Not detected
Escherichia coli O157:H7
E. coli O157 - would refer for H7
E. coli sorbitol-negative (would refer)
Not detected *
Not identified in stool
Not detected
Not identified in stool
Not detected
Not identified in stool
Not detected
Not identified in stool
Not detected
Not identified in stool
Not detected
* Incorrect result
Page 18 of 19
2015-BactiReg2
Event Notes
No. of
Participants
31
31
7
3
20
17
2
1
31
1
41
3
42
3
34
2
36
2
NP-10: Sample contained Plesiomonas shigelloides >10,000 CFU/Loop and Enterobacter aerogenes >10,000
CFU/Loop.
Aeromonas
Campylobacter
Referee
Consensus
100%
100%
E. coli O157:H7
100%
Plesiomonas
67% ^
Salmonella
100%
Shigella
100%
Vibrio
100%
Yersinia
100%
Organism
Participant Responses
Not identified in stool
Not identified in stool
Negative by Immunoassay
Not detected
Not identified in stool
Not detected
Plesiomonas shigelloides
Detected
Not identified in stool
Not identified in stool
Not detected
Not identified in stool
Not detected
Not identified in stool
Not detected
Not identified in stool
Not detected
No. of
Participants
31
31
7
3
39
1
17
1
14
41
3
42
3
34
2
36
2
^Scoring Note: Referee laboratory responses did not reach the 80% consensus requirement; therefore,
results were not scored. All responses for Plesiomonas received a 100% non-consensus score, and laboratories
must perform a written self-evaluation of their response to document participation for their lab surveyor.
Sample Note: This sample contained equal concentrations of P. shigelloides and E. aerogenes, which may
have similar morphologies on blood agar. These two organisms can be distinguished by performing an oxidase
test (P. shigelloides is oxidase positive). A stool culture can be screened for the presence of Aeromonas,
Plesiomonas, and Vibrio species by performing a sweep oxidase test on any blood agar growth.
Page 19 of 19
2015-BactiReg2
Event Notes