BactiReg3 Event Notes Module Page(s) 4-9 (TUL) Page 1 of 21

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1 Agriculture Drive Madison, WI (800) (608) BactiR Reg3 Shipment Date: September 14, 2015 Questions or comments should be directed to Amanda Weiss at x51 or Important Information: PT Central Updates: Enhancements will continue to be added. 90% of participants are reporting results online at PT-Central.. Thank you! General instructions are located online at 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 thee upper right cornerr 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 attachment, notification, or Paper. Paper reports will only be mailed to facilities thatt are not set up to receive s. Please notify us at or use the Contact Us option on the website if you wish to change your data entry or report settings. Specific Sample Notes: Module 5090 Gram Stain (GS) 5030 Bacteriology Comprehensive (MCP) 5040 Bacteriology Limited (MCL) 5250 Throat / Urine Bacteriology (TU) 5260 Throat / Urine Bacteriology Limited (TUL) 5270 Urine Culture (UC) 5080 Enteric Pathogens Culture (NP) Page(s) Mark Your Calendars Now! Next Eventt Ships: February 15, 2016 Re-enrollment letters have been mailed. MUST re-enroll to receive samples in 2016! Page 1 of 21

2 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 E. coli K1. 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-12 N. meningitidis Group B/E. coli K1 Participant Results Positive Negative BD Directigen 3 9 Wellcogen 1 2 Total 4 11 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): Sample GC-12 was not scored due to <10 participants reporting results. All laboratories must perform a self-evaluation of this sample to document participation for their lab surveyors. 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) Manual of Clinical Microbiology. 10 th ed. ASM Press, Washington, D.C. Page 2 of 21

3 Module 5090 (Gram Stain) Gram Stain Organisms & Target Responses Sample Sample Contents Gram Reaction Target Morphology GS-11 Fusobacterium nucleatum Gram negative Rods/bacilli GS-12 Neisseria gonorrhoeae Gram negative Diplococci GS-13 Bacillus cereus Gram positive Rods/bacilli GS-14 Staphylococcus aureus Gram positive Cocci GS-15 Candida albicans Gram positive Yeast Sample Gram Stain Referee and Participant Results Analyte Referee Consensus Response Participant GS-11 Gram reaction 100% Gram negative Morphology 100% Rods/bacilli GS-12 Gram reaction 94% Gram negative Gram positive * Morphology 100% Diplococci Cocci Coccobacilli * 1 1 Rods/bacilli * 1 1 GS-13 Gram reaction 100% Gram positive Gram negative * 8 11 Morphology 100% Rods/bacilli Diplococci * 1 1 Cocci * 2 3 GS-14 Gram reaction 100% Gram positive Gram negative * 4 5 Morphology 100% Cocci Diplococci * 4 5 GS-15 Gram reaction 100% Gram positive Gram negative * 1 1 Morphology 90% Yeast Cocci * 5 7 Page 3 of 21

4 Modules 5030 and 5040 (Bacteriology Comprehensive and Bacteriology Limited) Sample ID Requested Procedure/Analyte(s) Target Organism/Result MC-19 Group A streptococcus antigen Positive for Group A streptococcus antigen MC-20 Group A streptococcus screen Positive for Group A streptococcus MC-21 Neisseria gonorrhoeae screen Positive for Neisseria gonorrhoeae MC-22 Aerobic culture (wound) Staphylococcus aureus Susceptibility testing Appropriate antimicrobials & susceptibilities Urine culture Enterococcus faecium MC-23 Gram stain Gram positive cocci Susceptibility testing Appropriate antimicrobials & susceptibilities MC-24 Gram Stain Gram positive yeast MC-25 Anaerobic culture Actinomyces meyeri MC-26 Aerobic culture (eye) Bacillus cereus MC-27 Stool Culture Shigella boydii Please note: Samples MC-24 through MC-27 are not included in module 5040 (Bacteriology Limited). MC-19 (Group A streptococcus antigen detection), MC-20 (Group A streptococcus culture), and MC-21 (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-22 (Aerobic wound culture): Sample contained Staphylococcus aureus >100,000 CFU/Loop and Staphylococcus epidermidis <10,000 CFU/Loop. Referee consensus: 100% Staphylococcus aureus 69 Staphylococcus coagulase positive 1 Gram positive cocci 1 99 Growth observed (would refer) 1 Staphylococcus aureus - MRSA * 1 1 Page 4 of 21

5 MC-23 (Urine culture): Sample contained Enterococcus faecium >100,000 CFU/Loop. Referee consensus: Culture = 98% Gram reaction = 100% Gram morphology = 100% Enterococcus faecium 57 Enterococcus species 19 Gram positive cocci 5 Gram positive bacteria 1 97 Growth observed (would refer) 16 Growth 23 Enterococcus faecalis * 1 <1 Staphylococcus coagulase negative * 1 <1 Gram negative rod/bacilli * 1 <1 No growth * 1 <1 Gram Stain Responses Gram positive Cocci Yeast * 1 1 MC-24 (Gram Stain, source = ear): Sample contained Gram positive yeast (Candida albicans). Referee consensus: Gram reaction = 100% Gram morphology = 95% Gram Stain Responses Gram positive Gram negative * 1 2 Yeast Cocci * 2 3 Rods/bacilli * 1 1 Page 5 of 21

6 MC-25 (Anaerobic abscess culture): Sample contained Actinomyces meyeri >100,000 CFU/Loop and Corynebacterium sp. <10,000 CFU/Loop. Referee consensus: 88% Actinomyces meyeri 8 Actinomyces species 10 Anaerobic Gram positive rod 4 69 Anaerobic Gram positive bacterium 2 Anaerobe seen (would refer) 7 Anaerobic Gram negative rod * 1 2 Anaerobic Gram positive cocci * 1 2 Peptostreptococcus species * 1 2 No anaerobes isolated * Growth observed in Anaerobic bottle (would refer) * 1 2 Scoring Note: Although the participant consensus is < 80%, WSLH PT is required to score the sample accordingly when the referee consensus is 80%. MC-26 (Eye culture): Sample contained Bacillus cereus >100,000 CFU/Loop. Referee consensus: 100% Bacillus cereus 5 Bacillus species 12 Bacillus species, not anthracis Gram positive rod/bacilli 16 Growth observed (would refer) 10 Corynebacterium species * 1 2 Normal Flora isolated * 2 3 Page 6 of 21

7 MC-27 (Stool for enteric pathogens): Sample contained Shigella boydii >100,000 CFU/Loop, Proteus vulgaris >100,000 CFU/Loop and Klebsiella oxytoca >100,000 CFU/Loop. Organism Referee Consensus Participant Responses No. of Aeromonas 100% Not identified in stool 35 Campylobacter 100% Not identified in stool 38 Negative by immunoassay 12 E. coli O157:H7 100% Not identified in stool 44 Plesiomonas 100% Not identified in stool 32 Salmonella 100% Not identified in stool 55 Shigella 60%^ Shigella boydii 6 Shigella species 36 Shigella sonnei * 2 Not identified in stool * 10 Vibrio 100% Not identified in stool 23 Yersinia 91% Not identified in stool 27 Yersinia enterocolitica * 1 Yersinia species * 1 ^Scoring Note: Referee laboratory responses did not reach the 80% consensus requirement and, therefore, results were not scored. All the Shigella responses received a 100% non-consensus score, and laboratories must perform a written self-evaluation of their response to document participation for their lab surveyor. Page 7 of 21

8 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. 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: MC-22 (S. aureus in wound) All penicillinase-stable penicillins, beta-lactam/beta-lactamase inhibitor combinations, cephems, and carbapenems were scored regardless of the number of laboratories reporting results. According to the CLSI M100-S25 document, oxacillin (or cefoxitin) susceptible isolates of S. aureus can be considered susceptible to any of these agents. Therefore, all susceptible interpretations were acceptable responses for these antimicrobials. Any MIC values or zone sizes reported with susceptible interpretations for these antimicrobials were not scored. Similarly, S. aureus isolates that are resistant to penicillin can also be considered resistant to penicillinase-labile penicillins such as ampicillin. Therefore, all resistant results for ampicillin were acceptable, and any MIC value or zone sizes reported with resistant interpretations for these antimicrobials were not scored. Oxacillin & Vancomycin Disk Testing: According to the CLSI M100-25, disk diffusion testing is not reliable for oxacillin and vancomycin. Oxacillin testing should be performed by MIC. Alternatively, cefoxitin may be tested by disk diffusion or MIC and used as a surrogate to predict results of oxacillin. Vancomycin should be tested by MIC since disk diffusion does not differentiate between vancomycin susceptible and intermediate isolates of S. aureus. Not Scored Antimicrobials: The S. aureus in this sample displayed inducible clindamycin resistance. According to Table 3G of the CLSI M100-S25 document, clindamycin should be reported as Resistant for isolates with inducible clindamycin resistance. Therefore, all resistant interpretations for clindamycin were acceptable, and any non-resistant MIC values or zone sizes were not scored. Cefoxitin, chloramphenicol, doxycycline, quinupristin-dalfopristin, and tigecycline were not scored due to less than 10 laboratories reporting results. Page 8 of 21

9 Inappropriate Antimicrobials: Appropriate antimicrobials for S. aureus are listed in Table 2C, Staphylococcus spp., of the CLSI M100-S25 document. Antimicrobials that are considered inappropriate according to this table received a 0% score. Please note that nitrofurantoin should only be reported on urine sources. Sample Specific Notes: MC-23 (E. faecium in urine) Clindamycin, trimethoprim-sulfamethoxazole, all cephalosporins, and all aminoglycosides (except for synergy screens) were scored regardless of the number of laboratories reporting results. According to the CLSI M100-S25 document, Enterococcus isolates should not be reported as susceptible to any of these agents. Therefore, all resistant interpretation results were acceptable for these antimicrobials. Any MIC values or zone sizes reported for these antimicrobials were not scored since there are no breakpoint values listed in Table 2D of the CLSI M100-S25 document. Please note that these agents are not clinically effective against Enterococcus species even though they may appear susceptible in vitro. Doxycycline was scored based on the consensus results of tetracycline. Not scored antimicrobials: According to the CLSI M100-S25 document, penicillin results may be used to predict the susceptibility of ampicillin, ampicillin-sulbactam, amoxicillin, amoxicillin-clavulanic acid, piperacillin and piperacillin-tazobactam. Similarly, the results of ampicillin may be used to predict the susceptibility of amoxicillin, amoxicillin-clavulanic acid, ampicillinsulbactam, piperacillin and piperacillin-tazobactam. Therefore, these antimicrobials were scored based on the consensus response for penicillin and/or ampicillin. Any MIC values reported for the predicted antimicrobials were not scored since there are no breakpoint values listed in Table 2D of the CLSI M100-S25 document. Norfloxacin, rifampin, and tigecycline were not scored due to less than 10 laboratories reporting results. Nitrofurantoin interpretation responses did not reach the required 80% consensus for the Vitek2 and All Methods peer groups. All nitrofurantoin responses in these peer groups were not scored due to non-consensus. The table below shows the nitrofurantoin responses by method. The nitrofurantoin interpretation responses in the Microscan peer group reached 82% consensus and were therefore scored accordingly. Antimicrobial Susceptibility Interpretations by Method for Sample MC 23 Antimicrobial Agent Inappropriate antimicrobials: Interpretation Disk Diffusion Microscan Vitek2 Nitrofurantoin Susceptible Intermediate 5 13 Resistant 1 2 Appropriate antimicrobials for E. faecalis are listed in Table 2D, Enterococcus spp., of the CLSI M100-S25 document. Antimicrobials that are considered inappropriate according to this table received a 0% score. Please note that erythromycin is not recommended for reporting on urine sources. Quinupristin-dalfopristin (Synercid) should only be reported on vancomycin-resistant E. faecium. Page 9 of 21

10 Modules 5250 and 5260 (Throat/Urine Bacteriology and Throat/Urine Bacteriology Limited) Sample ID Requested Procedure/Analyte(s) Primary Target Organism/Result TU-15 Urine culture Streptococcus group B (agalactiae) TU-16 Urine culture Acinetobacter baumannii Urine culture Enterococcus faecium TU-17 Gram stain Gram positive cocci Susceptibility testing Appropriate antimicrobials & susceptibilities TU-18 Group A streptococcus culture Positive for Group A streptococcus TU-19 Group A streptococcus culture Positive for Group A streptococcus TU-20 Group A streptococcus antigen Positive for Group A streptococcus antigen TU-21 Group A streptococcus antigen Positive for Group A streptococcus antigen Please note: Samples TU-20 and TU-21 are not included in the Throat/Urine Bacteriology--Limited (5260) module. TU-15 (Urine culture): Sample contained Streptococcus agalactiae >100,000 CFU/Loop and Staphylococcus epidermidis <10,000 CFU/Loop. Referee consensus = 100% Streptococcus group B (agalactiae) 4 Streptococcus species 1 Gram positive cocci 2 Gram positive bacteria 3 90 Growth observed (would refer) 12 Growth 22 Gram negative rod/bacilli * 1 2 Staphylococcus coagulase negative * 1 2 No growth * 3 6 Page 10 of 21

11 TU-16 (Urine culture): Sample contained Acinetobacter baumannii >100,000 CFU/Loop and Corynebacterium sp. <10,000 CFU/Loop. Referee consensus = 90% Acinetobacter baumannii 1 Acinetobacter species 2 Gram negative rod/bacilli 1 Gram negative bacteria 1 90 Growth observed (would refer) 16 Growth 23 Enterobacteriaceae species * 1 2 Providencia species * 1 2 Gram negative cocci * 1 2 Gram positive cocci * 1 2 No growth * 1 2 TU-17 (Urine culture): Sample contained Enterococcus faecium >100,000 CFU/Loop. Referee consensus: Culture = 98% Gram reaction = 100% Gram morphology = 100% Enterococcus faecium 57 Enterococcus species 19 Gram positive cocci 5 Gram positive bacteria 1 97 Growth observed (would refer) 16 Growth 23 Enterococcus faecalis * 1 <1 Staphylococcus coagulase negative * 1 <1 Gram negative rod/bacilli * 1 <1 No growth * 1 <1 Gram Stain Responses Gram positive Cocci Yeast * 1 1 TU-18 and TU-19 (Group A streptococcus culture) and TU-20 and TU-21 (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. Page 11 of 21

12 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. 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: TU-17 (E. faecium in urine) Clindamycin, trimethoprim-sulfamethoxazole, all cephalosporins, and all aminoglycosides (except for synergy screens) were scored regardless of the number of laboratories reporting results. According to the CLSI M100-S25 document, Enterococcus isolates should not be reported as susceptible to any of these agents. Therefore, all resistant interpretation results were acceptable for these antimicrobials. Any MIC values or zone sizes reported for these antimicrobials were not scored since there are no breakpoint values listed in Table 2D of the CLSI M100-S25 document. Please note that these agents are not clinically effective against Enterococcus species even though they may appear susceptible in vitro. Doxycycline was scored based on the consensus results of tetracycline. Not scored antimicrobials: According to the CLSI M100-S25 document, penicillin results may be used to predict the susceptibility of ampicillin, ampicillin-sulbactam, amoxicillin, amoxicillin-clavulanic acid, piperacillin and piperacillin-tazobactam. Similarly, the results of ampicillin may be used to predict the susceptibility of amoxicillin, amoxicillin-clavulanic acid, ampicillinsulbactam, piperacillin and piperacillin-tazobactam. Therefore, these antimicrobials were scored based on the consensus response for penicillin and/or ampicillin. Any MIC values reported for the predicted antimicrobials were not scored since there are no breakpoint values listed in Table 2D of the CLSI M100-S25 document. Norfloxacin, rifampin, and tigecycline were not scored due to less than 10 laboratories reporting results. Nitrofurantoin interpretation responses did not reach the required 80% consensus for the Vitek2 and All Methods peer groups. All nitrofurantoin responses in these peer groups were not scored due to non-consensus. The following table shows the nitrofurantoin responses by method. Page 12 of 21

13 The nitrofurantoin interpretation responses in the Microscan peer group reached 82% consensus and were therefore scored accordingly. Antimicrobial Susceptibility Interpretations by Method for Sample TU 17 Antimicrobial Agent Inappropriate antimicrobials: Interpretation Disk Diffusion Microscan Vitek2 Nitrofurantoin Susceptible Intermediate 5 13 Resistant 1 2 Appropriate antimicrobials for E. faecalis are listed in Table 2D, Enterococcus spp., of the CLSI M100-S25 document. Antimicrobials that are considered inappropriate according to this table received a 0% score. Please note that erythromycin is not recommended for reporting on urine sources. Quinupristin-dalfopristin (Synercid) should only be reported on vancomycin-resistant E. faecium. Page 13 of 21

14 Module 5270 (Urine culture) Sample ID UC-11 UC-12 UC-13 UC-14 UC-15 Requested Procedure/Analyte(s) Urine culture Gram stain Urine culture Gram stain Urine culture Gram stain Urine culture Gram stain Urine culture Gram stain Susceptibility testing Target Organism/Result Escherichia coli Gram negative rods/bacilli Streptococcus group B (agalactiae) Gram positive cocci Morganella morganii Gram negative rods/bacilli Acinetobacter baumannii Gram negative rods/bacilli Enterococcus faecium Gram positive cocci Appropriate antimicrobials & susceptibilities Scoring Note: The Gram stain portion of samples UC-11, UC-12, UC-13 and UC-14 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 x51 with any questions. UC-11: Sample contained Escherichia coli >100,000 CFU/Loop and viridans streptococci <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. Escherichia coli 4 Gram negative rod/bacilli 1 Growth observed (would refer) 4 93 Growth 5 E.coli sorbitol-neg (would refer) * 1 7 Gram Stain Responses (Not Scored) Gram negative Rods/bacilli 3 75 Coccobacilli 1 25 Page 14 of 21

15 UC-12: Sample contained Streptococcus agalactiae >100,000 CFU/Loop and Staphylococcus epidermidis <10,000 CFU/Loop. Referee consensus = 100% Streptococcus group B (agalactiae) 4 Streptococcus species 1 Gram positive cocci 2 Gram positive bacteria 3 90 Growth observed (would refer) 12 Growth 22 Gram negative rod/bacilli * 1 2 Staphylococcus coagulase negative * 1 2 No growth * 3 6 Gram Stain Responses (Not Scored) Gram positive Cocci UC-13: Sample contained Morganella morganii >100,000 CFU/Loop. Peer consensus = 93% Scoring Note: Less than 10 referee laboratories submitted results for this sample; therefore, it was scored by peer consensus. Morganella morganii 4 Gram negative rod/bacilli 1 Growth observed (would refer) 4 93 Growth 5 Proteus mirabilis * 1 7 Gram Stain Responses (Not Scored) Gram negative Rods/bacilli 3 75 Coccobacilli 1 25 Page 15 of 21

16 UC-14: Sample contained Acinetobacter baumannii>100,000 CFU/Loop and Corynebacterium species <10,000 CFU/Loop. Referee consensus = 90% Acinetobacter baumannii 1 Acinetobacter species 2 Gram negative rod/bacilli 1 Gram negative bacteria 1 90 Growth observed (would refer) 16 Growth 23 Enterobacteriaceae species * 1 2 Providencia species * 1 2 Gram negative cocci * 1 2 Gram positive cocci * 1 2 No growth * 1 2 Gram Stain Responses (Not Scored) Gram negative Rods/bacilli 2 50 Coccobacilli 1 25 Diplococci 1 25 Page 16 of 21

17 UC-15: Sample contained Enterococcus faecium >100,000 CFU/Loop. Referee consensus: Culture = 98% Gram reaction = 100% Gram morphology = 100% Enterococcus faecium 57 Enterococcus species 19 Gram positive cocci 5 Gram positive bacteria 1 97 Growth observed (would refer) 16 Growth 23 Enterococcus faecalis * 1 <1 Staphylococcus coagulase negative * 1 <1 Gram negative rod/bacilli * 1 <1 No growth * 1 <1 Gram Stain Responses Gram positive Cocci Yeast * 1 1 General AST Notes: Antimicrobial Susceptibility Testing (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. 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. Page 17 of 21

18 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-15 (E. faecium in urine) Clindamycin, trimethoprim-sulfamethoxazole, all cephalosporins, and all aminoglycosides (except for synergy screens) were scored regardless of the number of laboratories reporting results. According to the CLSI M100-S25 document, Enterococcus isolates should not be reported as susceptible to any of these agents. Therefore, all resistant interpretation results were acceptable for these antimicrobials. Any MIC values or zone sizes reported for these antimicrobials were not scored since there are no breakpoint values listed in Table 2D of the CLSI M100-S25 document. Please note that these agents are not clinically effective against Enterococcus species even though they may appear susceptible in vitro. Doxycycline was scored based on the consensus results of tetracycline. Not scored antimicrobials: According to the CLSI M100-S25 document, penicillin results may be used to predict the susceptibility of ampicillin, ampicillin-sulbactam, amoxicillin, amoxicillin-clavulanic acid, piperacillin and piperacillin-tazobactam. Similarly, the results of ampicillin may be used to predict the susceptibility of amoxicillin, amoxicillin-clavulanic acid, ampicillinsulbactam, piperacillin and piperacillin-tazobactam. Therefore, these antimicrobials were scored based on the consensus response for penicillin and/or ampicillin. Any MIC values reported for the predicted antimicrobials were not scored since there are no breakpoint values listed in Table 2D of the CLSI M100-S25 document. Norfloxacin, rifampin, and tigecycline were not scored due to less than 10 laboratories reporting results. Nitrofurantoin interpretation responses did not reach the required 80% consensus for the Vitek2 and All Methods peer groups. All nitrofurantoin responses in these peer groups were not scored due to non-consensus. The table below shows the nitrofurantoin responses by method. The nitrofurantoin interpretation responses in the Microscan peer group reached 82% consensus and were therefore scored accordingly. Antimicrobial Susceptibility Interpretations by Method for Sample UC 15 Antimicrobial Agent Inappropriate antimicrobials: Interpretation Disk Diffusion Microscan Vitek2 Nitrofurantoin Susceptible Intermediate 5 13 Resistant 1 2 Appropriate antimicrobials for E. faecalis are listed in Table 2D, Enterococcus spp., of the CLSI M100-S25 document. Antimicrobials that are considered inappropriate according to this table received a 0% score. Please note that erythromycin is not recommended for reporting on urine sources. Quinupristin-dalfopristin (Synercid) should only be reported on vancomycin-resistant E. faecium. Page 18 of 21

19 Module 5080 (Enteric Pathogens) Sample ID NP-11 NP-12 NP-13 NP-14 NP-15 Target Organism/Result Negative for enteric pathogens Salmonella Typhimurium Campylobacter jejuni Vibrio parahaemolyticus Shigella boydii NP-11: Sample contained Citrobacter freundii >100,000 CFU/Loop, Klebsiella oxytoca >100,000 CFU/Loop, and Enterococcus faecalis >1,000 CFU/Loop (negative for enteric pathogens). Organism Referee Consensus Participant Responses No. of Aeromonas 100% Not identified in stool 31 Campylobacter 100% Not identified in stool 31 Negative by Immunoassay 6 E. coli O157:H7 100% Not identified in stool 39 Plesiomonas 100% Not identified in stool 31 Salmonella 100% Not identified in stool 42 Shigella 100% Not identified in stool 42 Vibrio 100% Not identified in stool 34 Yersinia 100% Not identified in stool 36 NP-12: Sample contained Salmonella enterica subspecies enterica serotype Typhimurium>100,000 CFU/Loop, and Citrobacter freundii >100,000 CFU/Loop. Organism Referee Consensus Participant Responses No. of Aeromonas 100% Not identified in stool 31 Campylobacter 100% Not identified in stool 31 Negative by Immunoassay 6 E. coli O157:H7 100% Not identified in stool 39 Plesiomonas 100% Not identified in stool 31 Salmonella 100% Salmonella Typhimurium 21 Salmonella enterica 1 Salmonella species 19 Detected 1 Salmonella Enteritidis * 1 Not identified in stool * 1 Shigella 100% Not identified in stool 42 Vibrio 100% Not identified in stool 34 Yersinia 100% Not identified in stool 36 * Incorrect result Page 19 of 21

20 NP-13: Sample contained Campylobacter jejuni >10,000,000 CFU/Loop, Pseudomonas aeruginosa >100,000 CFU/Loop and Escherichia coli >100,000 CFU/Loop. Organism Referee Consensus Participant Responses No. of Aeromonas 100% Not identified in stool 31 Campylobacter 100% Campylobacter jejuni 20 Campylobacter species 12 Positive by Immunoassay 6 Detected 1 E. coli O157:H7 100% Not identified in stool 39 Plesiomonas 100% Not identified in stool 31 Salmonella 100% Not identified in stool 42 Shigella 100% Not identified in stool 41 Shigella species * 1 Vibrio 100% Not identified in stool 34 Yersinia 100% Not identified in stool 36 * Incorrect result NP-14: Sample contained Vibrio parahaemolyticus >1,000,000 CFU/Loop and Hafnia alvei >100,000 CFU/Loop. Organism Referee Consensus Participant Responses No. of Aeromonas 100% Not Identified in stool 31 Campylobacter 100% Not identified in stool 31 Negative by Immunoassay 6 E. coli O157:H7 100% Not identified in stool 39 Plesiomonas 100% Not identified in stool 31 Salmonella 100% Not identified in stool 41 Salmonella species * 1 Shigella 100% Not identified in stool 42 Vibrio 100% Vibrio parahaemolyticus 28 Vibrio species 5 Not identified in stool * 1 Yersinia 100% Not identified in stool 36 * Incorrect result Page 20 of 21

21 NP-15: Sample contained Shigella boydii >100,000 CFU/Loop, Proteus vulgaris >100,000 CFU/Loop and Klebsiella oxytoca >100,000 CFU/Loop. Organism Referee Consensus Participant Responses No. of Aeromonas 100% Not identified in stool 31 Campylobacter 100% Not identified in stool 31 Negative by Immunoassay 6 E. coli O157:H7 100% Not identified in stool 39 Plesiomonas 100% Not identified in stool 31 Salmonella 100% Not identified in stool 42 Shigella 60% ^ Shigella boydii 10 Shigella species 13 Detected 1 Shigella sonnei 10 Not identified in stool 10 Vibrio 100% Not identified in stool 34 Yersinia 100% Not identified in stool 34 Yersinia enterocolitica * 1 Yersinia species * 1 ^Scoring Note: Referee laboratory responses did not reach the 80% consensus requirement; therefore, results were not scored. All responses for Shigella received a 100% non-consensus score, and laboratories must perform a written selfevaluation of their response to document participation for their lab surveyor. Page 21 of 21