BACTERIOLOGY PROFICIENCY TESTING PROGRAM

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1 BACTERIOLOGY PROFICIENCY TESTING PROGRAM Comprehensive Category January 14, 2013 If you have any questions or comments, please contact either: Dr. Wendy Archinal Dr. Kimberlee Musser Phone: (518)

2 TABLE OF CONTENTS Page General Information on the Bacteriology PT Program 1 Notes of Interest 2 Online Instructions and Worksheets 2 Bacteriology Questionnaires 2 EPTRS Reporting Tips 2 NYS Reportable Disease List 2 Samples for Remediation 2 Participating Laboratory Statistics - Grade Distribution 3 Answer Key 4 Referee Laboratory Results 5 Critique 6 Specimen Number 1 6 Specimen Number 2 7 Specimen Number 3 8 Specimen Number 4 10 Antibiotic Susceptibility Results 11 Specimen Number 5 13 Chlamydia Direct Detection 14 Group A Streptococcus - Direct Detection 15 Summary of Results Reported by Participating Laboratories 16

3 Bacteriology Proficiency Testing Program GENERAL INFORMATION The Bacteriology Proficiency Testing Program. Three proficiency testing events are given annually, each consisting of a minimum of five specimens. In order to successfully complete a test event, participating laboratories must achieve a score of 80% or greater. Unsuccessful performance in the testing program is defined as a score of less than 80% on two of three consecutive test events. Authentication. The presence and identity of the organism(s) in each specimen must be confirmed by at least 80% of the referee or participating laboratories. Referee laboratories are selected from New York State participating laboratories (located throughout the State) with acceptable and reproducible levels of performance. Grading System. Laboratories are to process proficiency test specimens in the same manner as patient specimens. Thus, laboratories are responsible for identifying test isolates to the same level as performed on patient isolates. If your laboratory speciates an organism on special request, then you must also speciate it in the proficiency test; consider speciation to have been requested on all reportable isolates. In addition, laboratories are not responsible for culturing any test samples from specimen sources which they do not process. Information regarding your laboratory s reporting protocol was provided to us in the questionnaire previously distributed to all laboratories. Any changes in reporting protocol must be received by our office prior to the mailout date for proficiency testing for that information to be considered in grading. Our testing format is in compliance with Center for Medicare & Medicaid Services guidelines as specified in the regulations of CLIA 88. One-half of our samples require identification of all organisms present. The other half require that only the pathogenic organism(s) be reported. We recognize the potential for any organism to be pathogenic depending on the clinical condition of the patient. However, our samples are designed so that only well-established pathogens should be reported. Tests are graded in adherence to CMS guidelines, as specified in the regulations of CLIA 88. Each of the specimens receives a score as determined by the following formula: (a + b)/(c + d + e) x 100% a = # correct identifications b = # correct antibiotic susceptibility results (if applicable) c = # possible identifications d = # possible antibiotic susceptibility results (if applicable) e = # additional organisms reported Grades for each sample are then averaged to determine the final grade for this testing event. Disclaimer The use of brand and/or trade names in this report does not constitute an endorsement of the products on the part of the Wadsworth Center or the New York State Department of Health. 1

4 Notes of Interest Reminder Proficiency test samples must be handled just like patient samples, to the extent possible. If you perform testing using one system on patient samples DO NOT use additional systems on proficiency samples. Several laboratories are reporting the use of multiple systems/methods to identify organisms or perform susceptibility tests. Unless you are using multiple systems on patient samples you must not do so on proficiency samples. A few laboratories are reporting both an MIC and a zone diameter for susceptibility results. Unless you are testing patient isolates using both a disk diffusion AND MIC method do not test proficiency samples using both methods. Online Instructions and Worksheets The instructions and worksheets for Bacteriology proficiency testing are available at the New York State Department of Health, Wadsworth Center website at Please bookmark this site to easily find the directions for the mailouts. Bacteriology Questionnaires Please update your questionnaire whenever there is a change in your laboratory s reporting policy. Proficiency test results are graded in accordance with information on the questionnaire so be certain that this information is accurate. If your questionnaire indicates that your laboratory reports an organism to the species level then you must report to the species level on the proficiency test to receive credit. If you need a copy of your questionnaire for review, please contact our office at or us at bacti@wadsworth.org. Grades will not be revised due to incorrect information on the questionnaire. EPTRS Reporting Tips When entering results into EPTRS if you can t find what you want in the drop down list you can select other and a text box appears for you to type in your response. NYS Reportable Disease List The New York State Reportable Disease List can be found at: Samples for Remediation We maintain a limited number of samples for remediation purposes. If your laboratory had difficulty isolating or identifying the organisms in a sample you can contact us after the event for additional samples. Contact us either by or phone and provide your PFI number and the sample(s) needed. They will be shipped to you within a week. 2

5 January 14, 2013 Test Event Number of Participating Laboratories: Receiving specimens 195 Submitting results 193 Grade Distribution Score Number Percent 100% % % <80%

6 BACTERIOLOGY - COMPREHENSIVE January 14, 2013 ANSWER KEY Specimen Number 1 - Stool (Pathogens only) Campylobacter jejuni Specimen Number 2 Cervix (Pathogens only) Neisseria gonorrhoeae Specimen Number 3 Wound - Aerobic / Anaerobic (Pathogens only) Bacteroides fragilis Enterococcus faecalis Specimen Number 4 - Blood (All organisms) and Antibiotic Susceptibility Klebsiella pneumoniae Susceptibility to: Ceftazidime - resistant Cefotaxime - resistant Specimen Number 5 - CSF (All organisms) Listeria monocytogenes Chlamydia Direct Detection - Cervix Positive for Chlamydia trachomatis Group A Streptococcus Direct Antigen Detection - Throat Negative for Group A Streptococcus 4

7 REFEREE LABORATORY RESULTS Specimen Number Referee Laboratory Responses Percent * 1 Campylobacter jejuni 70 Campylobacter species 30 2 Neisseria gonorrhoeae Bacteroides fragilis/fragilis group 70 Bacteroides species 30 Enterococcus faecalis 90 Enterococcus species 10 4 Klebsiella pneumoniae 100 Ceftazidime - resistant 100 Cefotaxime resistant Listeria monocytogenes 100 * Based on responses of 10 referee laboratories 5

8 Specimen Number 1 - Stool (Pathogens Only) This simulated stool specimen contained Campylobacter jejuni. Seventy percent of referee laboratories reported Campylobacter jejuni and 30% reported Campylobacter species. Of the participants that processed this sample, 59% reported Campylobacter jejuni and 33% reported Campylobacter species. Both responses were accepted. This sample also contained Enterobacter cloacae and Escherichia coli. Results reported for specimen # 1 Sample Result Method # Labs 1 Campylobacter jejuni Conventional biochemicals 86 biomerieux Vitek 2 NH 14 Not given 2 biomerieux Vitek 2 GN 1 BD Sensi-Disc 1 Polymerase chain reaction 1 Siemens (Dade Behring) Negative Combo - any panel 1 Campylobacter species Conventional biochemicals 54 biomerieux Vitek 2 NH 3 Remel ProsPect Campylobacter antigen EIA 1 Not given 1 Positive for Campylobacter antigens by EIA Meridian Premier Campy 1 No enteric pathogens isolated 11 No growth 1 No Salmonella or Shigella isolated. No other pathogens have been ruled out. Siemens (Dade Behring) Negative Combo - any panel 1 Specimen source not tested 14 Additional organisms reported Enterobacter cloacae biomerieux Vitek 2 GN 2 Escherichia coli biomerieux Vitek 2 GN 1 Conventional biochemicals 1 No Clostridium spp, No Bifidobacterium spp, No Bacteroides fragilis group 1 6

9 Specimen Number 2 Cervix (Pathogens only) This simulated cervical specimen contained Neisseria gonorrhoeae. It was identified by all the referee laboratories and 81% of the participating laboratories that processed this sample. This sample also contained Staphylococcus epidermidis and Neisseria mucosa. Results reported for specimen # 2 Sample Result Method # Labs 2 Neisseria gonorrhoeae Remel RapID NH 57 biomerieux API NH 27 biomerieux Vitek 2 NH 24 Siemens (Dade Behring) MicroScan HNID 18 Conventional biochemicals 13 Remel BactiCard Neisseria 2 Genprobe Accuprobe 2 biomerieux Vitek 2 GN 1 MALDI-TOF 1 Pyrosequencing 1 Polymerase chain reaction 1 Neisseria species biomerieux API NH 2 Remel RapID NH 1 No pathogens isolated 30 Staphylococcus, coagulase negative Conventional biochemicals 1 Enterococcus species Conventional biochemicals 1 Specimen source not tested 11 Additional organisms reported Bacteroides fragilis Remel RapID ANA II 1 7

10 Specimen Number 3 Wound - Aerobic/Anaerobic (Pathogens only) This wound sample contained Bacteroides fragilis and Enterococcus faecalis. Seventy percent of referee laboratories and 80% of participating laboratories reported either Bacteroides fragilis or Bacteroides fragilis group. Enterococcus faecalis was reported by 90% of referee laboratories and 88% of participating laboratories. Results reported for specimen # 3 Sample Result Method # Labs 3 Bacteroides fragilis Remel RapID ANA II 84 biomerieux Vitek 2 ANC 34 biomerieux API 20A 17 Siemens (Dade Behring) MicroScan Rapid Anaerobe 10 16s rdna sequencing 2 Conventional biochemicals 2 BD BBL Crystal Anaerobe 1 biomerieux API Rapid ID 32A 1 biomerieux Vitek 2 GN 1 MALDI-TOF 1 Bacteroides fragilis group Conventional biochemicals 4 Remel RapID ANA II 3 Siemens (Dade Behring) MicroScan Rapid Anaerobe 2 biomerieux Vitek 2 ANC 1 Not given 1 Bacteroides species Remel RapID ANA II 3 biomerieux Vitek 2 ANC 3 Siemens (Dade Behring) MicroScan Rapid Anaerobe 1 Anaerobic gram negative bacilli 1 Bacteroides uniformis Siemens (Dade Behring) MicroScan Rapid Anaerobe 2 Clostridium innocuum Remel RapID ANA II 1 No Bifidobacterium sp. isolated 1 Prevotella oris Remel RapID ANA II 1 Prevotella species Remel RapID ANA II 2 Anaerobes not cultured 11 No anaerobe reported 3 8

11 Sample Result Method # Labs 3 Enterococcus faecalis biomerieux Vitek 2 GP 77 Siemens (Dade Behring) Positive Combo - any panel 68 Conventional biochemicals 7 biomerieux API 20 Strep 5 BD Phoenix Gram Positive ID 4 Remel RapID STR 2 MALDI-TOF 2 biomerieux Vitek MS 1 Polymerase chain reaction 1 biomerieux Vitek 1 GPI 1 16s rdna sequencing 1 Enterococcus species Conventional biochemicals 18 Not given 2 Remel BactiCard Strep 1 Neisseria gonorrhoeae Conventional biochemicals 1 Specimen source not tested 1 Streptococcus, group D Remel Streptex 1 Additional organisms reported Siemens (Dade Behring) Positive Combo - Staphylococcus aureus any panel 1 Pseudomonas aeruginosa biomerieux Vitek 2 GN 1 Staphylococcus aureus Conventional biochemicals 1 No Clostridium spp, No Bifidobacterium spp 1 9

12 Specimen Number 4 - Blood (All organisms) and Antibiotic Susceptibility All referee and participating laboratories reported Klebsiella pneumoniae. All referee laboratories reported this organism resistant to both ceftazidime and cefotaxime. All participants reported the Klebsiella resistant to ceftazidime and 96% reported it resistant to cefotaxime. This organism was an ESBL producer. Several laboratories noted this in their results. From page 45 of the January 2013 CLSI Performance Standards for Antimicrobial Susceptibility Testing (M100-S23), Table 2A: Revised interpretive criteria for cephalosporins (cefazolin, cefotaxime, ceftazidime, ceftizoxime, and ceftriaxone) and aztreonam were first published in January 2010 (M100-S20) and are also listed in January 2013 (M100-S23), Table 2A. Cefazolin interpretive criteria were revised again in June 2010 and are also listed in January 2013 (M100-S23), Table 2A. Cefepime and cefuroxime (parenteral) were also evaluated; however, no change in interpretive criteria was required for the dosages indicated in January 2013 Table 2A. When using the current interpretive criteria, routine ESBL testing is no longer necessary before reporting results (ie, it is no longer necessary to edit results for cephalosporins, aztreonam, or penicillins from susceptible to resistant). However, ESBL testing may still be useful for epidemiological or infection control purposes. For laboratories that have not implemented the current interpretive criteria, ESBL testing should be performed as described in January 2013 Table 2A Supplemental Table 1. Results reported for specimen # 4 Sample Result Method # Labs 4 Klebsiella pneumoniae biomerieux Vitek 2 GN 87 Siemens (Dade Behring) Negative Combo - any panel 66 biomerieux API 20E 18 BD Phoenix Gram Negative ID 5 Conventional biochemicals 2 MALDI-TOF 2 BD BBL Crystal Enteric/Nonfermenter 1 biomerieux Vitek 1 GNI + 1 Specimen source not tested 10 Additional organisms reported No Clostridium spp, No Bifidobacterium spp 1 Bacteroides fragilis group Conventional biochemicals 1 10

13 Methods used for susceptibility testing Ceftazidime Result Method # Labs Zone MIC Resistant MicroScan 48 >16 3 >=16 1 > <16 2 Not given biomerieux Vitek 2 49 =16 2 Not given 2 >=64 1 >=16 1 N/A ESBL + BD Phoenix 3 > E-test 1 >256 1 = =24 Agar dilution 1 >16 In house prepared frozen mic 1 =32 Trek Sensititre 1 =16 1 =32 Not given 4 >16 1 =16 Disk diffusion Not given Screen Positive MicroScan 1 1 >16 Not given 1 Test not performed on antibiotic 37 Susceptibility testing not performed 2 11

14 Methods used for susceptibility testing Cefotaxime Result Method # Labs Zone MIC Resistant MicroScan 18 =8 9 >32 6 =32 5 =16 4 <=2 2 >=32 1 >=4 1 <2 1 >16 2 Not given biomerieux Vitek 2 4 =2 4 Not given 2 =4 1 N/A ESBL + E-test 2 =4 1 =3.0 1 =1.5 1 >256 In house prepared frozen mic 1 =4 Resistant based on ESBL Testing (present) 1 Trek Sensititre 1 =8 Not given > Disk diffusion Not given Screen Positive MicroScan 1 Screen Positive Not given 1 Intermediate biomerieux Vitek 2 1 =2 Intermediate Agar dilution 1 =2 Intermediate Disk diffusion 1 18 Susceptible Disk diffusion 1 26 Test not performed 100 Susceptibility testing not performed 2 12

15 Specimen Number 5 - CSF (All organisms) This simulated CSF specimen contained Listeria monocytogenes. It was reported by all referee laboratories and 97% of participating laboratories. Results reported for specimen # 5 Sample Result Method # Labs 5 Listeria monocytogenes biomerieux Vitek 2 GP 71 Siemens (Dade Behring) Positive Combo - any panel 51 Conventional biochemicals 26 biomerieux API Coryne 10 BD Phoenix Gram Positive ID 5 Remel RapID STR 3 Polymerase chain reaction 1 biomerieux Vitek 1 GPI 1 MALDI-TOF 1 Dupont Qualicon RiboPrinter 1 Remel RapID CB Plus 1 biomerieux Vitek 2 GN 1 biomerieux Vitek 2 ANC 1 Listeria species Conventional biochemicals 2 biomerieux Vitek 2 GP 1 Siemens (Dade Behring) Positive Combo - any panel 1 Specimen source not tested 16 Additional organisms reported No Clostridium spp, No Bifidobacterium spp, No Bacteroides fragilis group 1 13

16 Chlamydia - Cervix for Direct Detection Methods This simulated cervical swab was provided to laboratories that test for Chlamydia using direct detection methods. This sample contained non-viable organisms and was not suitable for laboratories performing Chlamydia culture. This sample was positive for Chlamydia trachomatis and was reported as such by 99% of the participating laboratories that tested this specimen. Test kits used by laboratories processing this specimen Result Method # Labs Positive Gen-Probe Aptima Combo 2 45 BD ProbeTec ET CT or CT/GC 18 Gen-Probe PACE 2 CT or CT/GC 11 Roche Diagnostics COBAS AMPLICOR CT/NG 3 biomerieux VIDAS 3 Roche Diagnostics AMPLICOR CT/NG 2 Digene Hybrid Capture hc2 CT/GC 2 Laboratory Developed Test 1 Abbott M Negative Roche Diagnostics COBAS AMPLICOR CT/NG 1 14

17 Group A Streptococcus Throat Swab for Direct Detection Methods This specimen was reported as negative for Group A Streptococcus by 100% of the participating laboratories that processed it. Test kits used by laboratories processing this specimen Result Method # Labs Negative Sekisui (Genzyme) OSOM Ultra Strep A 25 BioStar/Inverness Medical Acceava Strep A 14 BD Directigen EZ Strep A 10 Quidel QuickVue + Strep A 8 BD Chek Group A Strep 8 Cardinal Health SP Brand Strep A Dipstick 6 Fisher Sure-Vue Signature Strep A Test 5 Abbott Signify Strep A Dipstick 5 Fisher Sure-Vue Strep A Lateral Flow Test 4 Meridian Bioscience ImmunoCard STAT Strep A 4 Stanbio QuStick Strep A Rapid Strip Test 2 GenProbe Group A Strep 2 Henry Schein One Step + Strep A Dipstick 2 Beckman Coulter Icon DS Strep A 1 BTNX Rapid Response 1 Fisher Sure-Vue Strep A Test 1 Remel PathoDx Strep A latex Kit 1 Clearview Strep A Exact II Cassette 1 Quidel QuickVue Dipstick Strep A 1 Polymedco Poly Stat Strep A 1 15

18 BACTERIAL IDENTIFICATION BY PARTICIPATING LABORATORIES Sample/Report # Labs SPECIMEN NUMBER 1 (Stool) Campylobacter jejuni 106 Campylobacter species 59 Enterobacter cloacae 2 Escherichia coli 2 No enteric pathogens isolated 12 Positive for Campylobacter antigens by EIA 1 No Salmonella or Shigella isolated 1 No Clostridium, Bifidobacterium or Bacteroides fragilis group 1 Specimen source not tested 14 SPECIMEN NUMBER 2 (Cervix) Neisseria gonorrhoeae 147 Neisseria species 3 No pathogens isolated 30 Bacteroides fragilis 1 Enterococcus species 1 Staphylococcus, coagulase negative 1 Specimen source not tested 11 SPECIMEN NUMBER 3 (Wound) Bacteroides fragilis 153 Bacteroides fragilis group 11 Bacteroides species 7 Bacteroides uniformis 2 Clostridium innocuum 1 Anaerobic gram negative bacilli 1 No Bifidobacterium species isolated 1 No Clostridium or Bifidobacterium species isolated 1 Enterococcus faecalis 169 Enterococcus species 21 Prevotella species 2 Staphylococcus aureus 2 Neisseria gonorrhoeae 1 Prevotella oris 1 Pseudomonas aeruginosa 1 Streptococcus, group D 1 Specimen source not tested 1 SPECIMEN NUMBER 4 (Blood) Klebsiella pneumoniae 183 Bacteroides fragilis group 1 Specimen source not tested 10 SPECIMEN NUMBER 5 (CSF) Listeria monocytogenes 173 Listeria species 4 No Clostridium, Bifidobacterium or Bacteroides fragilis 1 Specimen source not tested 16 16

19 CHLAMYDIA DIRECT DETECTION (Cervix) Positive for Chlamydia trachomatis 86 Negative for Chlamydia trachomatis 1 GROUP A STREPTOCOCCUS - DIRECT DETECTION (Throat) Negative for Group A Streptococcus

BACTERIOLOGY PROFICIENCY TESTING PROGRAM

BACTERIOLOGY PROFICIENCY TESTING PROGRAM Comprehensive Category September 6, 2016 If you have any questions or comments, please contact either: Dr. Wendy Archinal Nellie Dumas Dr. Kimberlee Musser Phone: