BACTERIOLOGY PROFICIENCY TESTING PROGRAM
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1 BACTERIOLOGY PROFICIENCY TESTING PROGRAM Comprehensive Category September 3, 2013 If you have any questions or comments, please contact either: Dr. Wendy Archinal Dr. Kimberlee Musser Phone: (518)
2 TABLE OF CONTENTS General Information on the Bacteriology PT Program Page Notes of Interest Online Instructions and Worksheets Bacteriology Questionnaires EPTRS Reporting Tips NYS Reportable Disease List Samples for Remediation Participating Laboratory Statistics - Grade Distribution Answer Key Referee Laboratory Results Critique Specimen Number 1 Specimen Number 2 Antibiotic Susceptibility Results Specimen Number 3 Specimen Number 4 Specimen Number 5 Chlamydia Direct Detection Group A Streptococcus - Direct Detection Summary of Results Reported by Participating Laboratories
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. Contact information Please make sure that CLEP has the correct addresses for your laboratory contact people. On occasion we need to notify you of an issue with a sample and this is done by . 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. Make sure you have pop-ups enabled in your browser. 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 September 3, 2013 Test Event Number of Participating Laboratories: Receiving specimens 199 Submitting results 198 Grade Distribution Score Number Percent 100% % % <80%
6 BACTERIOLOGY - COMPREHENSIVE September 3, 2013 ANSWER KEY Specimen Number 1 - Stool (Pathogens only) Shigella sonnei Specimen Number 2 Blood (All organisms) Enterococcus gallinarum Specimen Number 3 Intra-abdominal abscess - Aerobic / Anaerobic (All organisms) Clostridium perfringens Streptococcus bovis Specimen Number 4 - Urine (Pathogens only) and Antibiotic Susceptibility Morganella morganii Susceptibility to: Ciprofloxacin - susceptible Nitrofurantoin - resistant Specimen Number 5 - Cervix (Pathogens only) Neisseria gonorrhoeae 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 Shigella sonnei, Group D 90 Shigella species 10 2 Enterococcus gallinarum 80 Enterococcus species 10 Enterococcus casseliflavus 10 3 Clostridium perfringens 80 Clostridium species 20 Streptococcus bovis 40 Streptococcus infantarius 50 Streptococcus species 10 4 Morganella morganii 70 Morganella morganii ss. morganii 30 Ciprofloxacin - susceptible 100 Nitrofurantoin - resistant Neisseria gonorrhoeae 100 * Based on responses of 10 referee laboratories 5
8 Specimen Number 1 - Stool (Pathogens Only) Correct response Shigella sonnei, Group D Results reported for specimen # 1 Result Method # Labs Shigella sonnei, group D biomerieux Vitek 2 GN 61 Siemens (Dade Behring) Negative Combo - any panel 45 biomerieux API 20E 25 BD Phoenix Gram Negative ID 5 biomerieux API Rapid 20E 2 Conventional biochemicals 1 biomerieux Vitek 1 GNI + 1 BBL Shigella antisera (A-D) 1 Remel RapID ONE 1 Not given 1 Shigella species biomerieux Vitek 2 GN 15 Siemens (Dade Behring) Negative Combo - any panel 11 biomerieux API 20E 4 BD BBL Crystal Enteric/Nonfermenter 1 Presumptive Shigella species Conventional biochemicals 1 Siemens (Dade Behring) Negative Combo - any panel 1 No enteric pathogens isolated Conventional biochemicals 7 Specimen source not tested 15 Additional organisms reported Escherichia coli biomerieux Vitek 2 GN 2 Remel RapID ONE 1 Morganella morganii biomerieux Vitek 2 GN 1 Morganella morganii ss. morganii biomerieux Vitek 2 GN 1 Proteus vulgaris Remel RapID ONE 1 6
9 Specimen Number 2 Blood (All organisms) Correct response Enterococcus gallinarum Results reported for specimen # 2 Result Method # Labs Enterococcus gallinarum biomerieux Vitek 2 GP 75 Siemens (Dade Behring) Positive Combo - any panel 46 Conventional biochemicals 5 biomerieux API 20 Strep 3 Other - MALDI-TOF 2 Remel RapID STR 2 BD Phoenix Gram Positive ID 2 Not given 1 biomerieux Vitek 1 GPI 1 Dupont Qualicon RiboPrinter 1 BD BBL Crystal Gram Positive 1 MALDI-TOF Mass Spectrometry 1 Enterococcus species Conventional biochemicals 16 biomerieux Vitek 2 GP 2 Siemens (Dade Behring) Positive Combo - any panel 2 biomerieux API 20 Strep 1 BD Phoenix Gram Positive ID 1 Enterococcus faecium Siemens (Dade Behring) Positive Combo - any panel 12 biomerieux API 20 Strep 2 Conventional biochemicals 1 Enterococcus casseliflavus biomerieux Vitek 2 GP 3 Streptococcus gallinarum Conventional biochemicals 1 Streptococcus, group D Conventional biochemicals 1 Remel Streptex 1 Streptococcus oralis Siemens (Dade Behring) Positive Combo - any panel 1 Streptococcus species Siemens (Dade Behring) Positive Combo - any panel 1 Specimen source not tested 13 7
10 Specimen Number 3 Intra-abdominal abscess - Aerobic/Anaerobic (All organisms) Correct result Clostridium perfringens Streptococcus bovis (also accepted were any member of the Streptococcus bovis Group, Group D Streptococcus and Streptococcus species) Results reported for specimen # 3 Result Method # Labs Clostridium perfringens Remel RapID ANA II 80 biomerieux Vitek 2 ANC 32 Siemens (Dade Behring) MicroScan Rapid Anaerobe 15 biomerieux API 20A 11 MALDI-TOF 4 Conventional biochemicals 3 BD BBL Crystal Anaerobe 1 biomerieux API Rapid ID 32A 1 Clostridium species Conventional biochemicals 4 Remel RapID ANA II 3 Siemens (Dade Behring) MicroScan Rapid Anaerobe 1 biomerieux Vitek 2 ANC 1 biomerieux API 20A 1 Clostridium septicum Remel RapID ANA II 1 No anaerobic organisms 1 Peptostreptococcus species Remel RapID ANA II 1 Propionibacterium acnes biomerieux Vitek 2 ANC 1 No Bifidobacterium species 1 Anaerobic Gram Positive Rod 2 Anaerobe not tested for the source 1 No anaerobic organisms 6 Specimen source not tested 2 No anaerobe reported 25 8
11 Result Method # Labs Streptococcus bovis Siemens (Dade Behring) Positive Combo - any panel 57 biomerieux Vitek 2 GP 34 biomerieux API 20 Strep 11 Remel RapID STR 7 Conventional biochemicals 7 biomerieux Vitek 1 GPI 2 BD Phoenix Gram Positive ID 2 MALDI-TOF 1 Siemens MicroStrep Plus 1 Streptococcus bovis group biomerieux Vitek 2 GP 1 Conventional biochemicals 1 MALDI-TOF 1 Streptococcus species Conventional biochemicals 12 biomerieux Vitek 2 GP 8 Siemens (Dade Behring) Positive Combo - any panel 3 BD Phoenix Gram Positive ID 1 biomerieux API 20 Strep 1 Strep Typing 1 Streptococcus infantarius biomerieux Vitek 2 GP 10 Streptococcus infantarius ssp coli biomerieux Vitek 2 GP 9 Streptococcus, group D Remel Streptex 3 biomerieux Vitek 2 GP 2 Conventional biochemicals 2 Streptococcus, group D not Enterococcus Conventional biochemicals 1 Remel RapID STR 1 Streptococcus bovis/lutetiensis 16s rdna sequencing 1 Streptococcus alactolyticus biomerieux Vitek 2 GP 1 Alpha-hemolytic Streptococcus Conventional biochemicals 5 biomerieux Vitek 2 GP 1 Gamma hemolytic strep Conventional biochemicals 1 Streptococcus mitis Siemens (Dade Behring) Positive Combo - any panel 2 Streptococcus intermedius biomerieux Vitek 2 GP 1 biomerieux API 20A 1 Streptococcus mutans biomerieux Vitek 2 GP 1 Streptococcus salivarius Remel RapID STR 1 Gram positive cocci 2 Specimen source not tested 2 9
12 Specimen Number 4 - Urine (Pathogens only) and Antibiotic susceptibility Correct result Morganella morganii Ciprofloxacin susceptible Nitrofurantoin - resistant Results reported for specimen # 4 Result Method # Labs Morganella morganii Siemens (Dade Behring) Negative Combo - any panel 67 biomerieux Vitek 2 GN 45 biomerieux API 20E 19 BD Phoenix Gram Negative ID 6 biomerieux API Rapid 20E 2 Not given 1 BD BBL Crystal Enteric/Nonfermenter 1 Other - MALDI-TOF 1 Morganella morganii ss. morganii biomerieux Vitek 2 GN 48 biomerieux Vitek 1 GNI + 2 Conventional biochemicals 1 Siemens (Dade Behring) Negative Combo - any panel 1 1 Providencia rustigianii BD BBL Crystal Enteric/Nonfermenter 1 Proteus stuartii BD BBL Crystal Enteric/Nonfermenter 1 Proteus vulgaris Remel RapID ONE 1 10
13 Susceptibility testing results Ciprofloxacin Result Method # Labs Zone MIC Susceptible biomerieux Vitek 2 77 <= Not given 1 < <=25 MicroScan 59 <=1 6 <1 BD Phoenix 6 <=0.5 E-test 2 = =.008 Trek Sensititre 2 <=0.5 Agar Dilution 1 <=1 in house prepared frozen mic 1 <=0.008 ug Not given 2 <=1 Disk diffusion Test not performed 12 Nitrofurantoin Resistant biomerieux Vitek 2 39 = =64 5 Not given 2 >=128 1 =123 MicroScan 9 =64 5 >64 1 <=32 BD Phoenix 4 =64 2 Not given Not given 1 =64 1 >64 Disk diffusion Intermediate MicroScan 44 =64 11
14 1 =>16 biomerieux Vitek 2 3 =64 Not given 2 =64 Trek Sensititre 1 64 Agar Dilution 1 =64 in house prepared frozen mic 1 =64 ug/ml Disk diffusion 1 15 Test not performed 16 12
15 Specimen Number 5 - Cervix (Pathogens only) Correct response Neisseria gonorrhoeae Results reported for specimen # 5 Result Method # Labs Neisseria gonorrhoeae Remel RapID NH 67 biomerieux API NH 30 biomerieux Vitek 2 NH 27 Siemens (Dade Behring) MicroScan HNID 23 Conventional biochemicals 14 biomerieux Vitek 1 NHI 3 Remel BactiCard Neisseria 3 GenProbe AccuProbe 3 16s rdna sequencing 2 Polymerase chain reaction 1 Dupont Qualicon RiboPrinter 1 Genprobe (Hologic) Aptima Amplified DNA 1 Not given 1 MALDI-TOF 1 No pathogens isolated 6 Gardnerella vaginalis Siemens (Dade Behring) MicroScan HNID 2 Remel RapID NH 2 Lactobacillus species Conventional biochemicals 1 Specimen source not tested 10 Additional organisms reported Alpha-hemolytic Streptococcus Conventional biochemicals 2 Gardnerella vaginalis Siemens (Dade Behring) MicroScan HNID 1 Listeria monocytogenes Siemens (Dade Behring) Positive Combo - any panel 1 Actinomyces naeslundii biomerieux Vitek 2 ANC 1 Lactobacillus species Conventional biochemicals 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 48 BD ProbeTec ET CT or CT/GC 19 Roche Diagnostics COBAS AMPLICOR CT/NG 5 Roche Diagnostics AMPLICOR CT/NG 2 Laboratory Developed Test 1 Abbott RealTime CT / NG 1 Digene Hybrid Capture hc2 CT/GC 1 Negative BD ProbeTec ET CT or CT/GC 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 Method # Labs Sekisui (Genzyme) OSOM Ultra Strep A 25 BioStar/Inverness Medical Acceava Strep A 16 BD Chek Group A Strep 10 BD Directigen EZ Strep A 8 Quidel QuickVue + Strep A 8 Cardinal Health SP Brand Strep A Dipstick 6 Meridian Bioscience ImmunoCard STAT Strep A 5 Abbott Signify Strep A Dipstick 5 Fisher Sure-Vue Signature Strep A Test 5 Fisher Sure-Vue Strep A Lateral Flow Test 4 Henry Schein One Step + Strep A Dipstick 2 Stanbio QuStick Strep A Rapid Strip Test 2 GenProbe Group A Strep 2 Beckman Coulter Icon DS Strep A 1 FISCHER SURE-VUE STREP A TEST 1 btnx rapid response 1 Beckman Coulter Icon SC Strep A 1 CLEARVIEW STREP A EXACT II DIPSTICK 1 Alere BinaxNow Strep A Card 1 Clearview Strep A Exact II Cassette 1 Quidel QuickVue Dipstick Strep A 1 Pathodx strep a latex kit 1 Polymedco Poly Stat Strep A 1 15
18 BACTERIAL IDENTIFICATION BY PARTICIPATING LABORATORIES Sample/Report # Labs % SPECIMEN NUMBER 1 (Stool) Shigella sonnei, group D Shigella species Presumptive Shigella species 2 1 No enteric pathogens isolated 7 4 Specimen source not tested 15 SPECIMEN NUMBER 2 (Blood) Enterococcus gallinarum Enterococcus species Enterococcus faecium 15 8 Enterococcus casseliflavus 3 2 Streptococcus gallinarum 1 <1 Streptococcus, group D 2 1 Streptococcus oralis 1 <1 Streptococcus species 1 <1 Specimen source not tested 13 SPECIMEN NUMBER 3 (Intra-abdominal abscess) Clostridium perfringens Clostridium species 10 5 Clostridium septicum 1 <1 No anaerobic organisms 1 <1 Peptostreptococcus species 1 <1 Propionibacterium acnes 1 <1 No Bifidobacterium species 1 <1 Anaerobic Gram Positive Rod 2 1 Anaerobe not tested for the source 1 <1 No anaerobic organisms 6 3 No anaerobe reported Specimen source not tested 2 Streptococcus bovis Streptococcus bovis group 3 2 Streptococcus species Streptococcus infantarius 10 5 Streptococcus infantarius ssp coli 9 5 Streptococcus, group D 7 4 Streptococcus, group D not Enterococcus 2 1 Streptococcus bovis/lutetiensis 1 <1 Streptococcus alactolyticus 1 <1 Alpha-hemolytic Streptococcus 6 3 Gamma hemolytic strep 1 <1 Streptococcus mitis 2 1 Streptococcus intermedius 2 1 Streptococcus mutans 1 <1 Streptococcus salivarius 1 <1 Gram positive cocci 2 1 Specimen source not tested 2 SPECIMEN NUMBER 4 (Urine) Morganella morganii Morganella morganii ss. Morganii Providencia rustigianii 1 <1 16
19 Proteus stuartii 1 <1 Proteus vulgaris 1 <1 SPECIMEN NUMBER 5 (Cervix) Neisseria gonorrhoeae No pathogens isolated 6 3 Gardnerella vaginalis 4 2 Lactobacillus species 1 <1 Specimen source not tested 10 CHLAMYDIA DIRECT DETECTION (Cervix) Result # Labs % Positive for Chlamydia trachomatis Negative for Chlamydia trachomatis 1 1 GROUP A STREPTOCOCCUS - DIRECT DETECTION (Throat) Negative for Group A Streptococcus
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