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Quality Control

Is user QC required for the tubes used to set up AFB in the Bactec MGIT 960 or is the manufacturer QC sufficient?

(answered 06/01/2007)

Is it ever an acceptable practice to use media past its expiration date as long as you do QC on the day that you use it?
(answered 02/12/2007)
For QC of non exempt media, are all the recommended QC organisms required to be used listed in the CLSI document M22 for CAP adherence.
(answered 02/05/2007)
On the CAP inspection sheet the question: MIC.21560 Are all non-immunofluorescent, non-immunologic-based stains (other thatn Gram stains) checked with a positive control and negative control for intended reactivity each day of use, and for each new batch, lot number, and shipment? We have Lactophenol cotton blue droppers used for our KOH testing. Does this stain pertain to the CAP question? We do no do Fungus cultures in-house but do the KOH testing when requested.
(answered 01/26/2007)
We are searching for a method on how to make gram stain control slides. We recently removed our autoclave and need a procedure to make them without autoclaving the organisms. Where can I locate the information?
(answered 01/04/2007)
I was recently asked by a technologist in our lab the following...Why do we manually add the time used on our Fluorescent scope? This is an old question, and would like to know if there are newer reference to this question. Thank you
(answered 11/09/2006)
Is there any proficency test available and/or required for Blood Cultures?
(answered 10/23/2006)
Hello! When we perform QC of home prepared Campy agar,we inoculate 10000 CFU on the agar (according to second edition of Isenberg). How many colonies must grow in this case? Any reference? Thanks.
(answered 09/05/2006)
Hi We have a very nice CO2 incubator with a CO2 readout. Currently we are checking the CO2 with fyrite monthly. We also sub a N. gonorhoeae daily as well to double check the CO2. Can we discontinue checking the fyrite so often, maybe going to quarterly or yearly?
(answered 05/12/2006)
Is there any lab SOP reference available on the QCing of bleach solutions used to decontaminate sputum samples for AFB smears at BL-2? E.g., what mycobacterial ATCC strain/MacFarland concentrations should be used.
(answered 05/03/2006)
IS IT OK TO USE NEW LOT VITEK CARDS WHEN QC SETUP IN PARALLEL?
(answered 04/03/2006)
We have a Lab Line CO2 incubator that is around 5 yrs old. We have to change the CO2 gas cylinders approx every 5-6 days. The configuration of the unit is poor such that when we open the door all the CO2 escapes. Do you know any mechanism we can add to the regualtor to shut the gas off when the door is opened?
(answered 03/31/2006)
Is heat fixing slides for gram stain really necessary? We do not have a Cinerator. If required, could you suggest an alternative to the Cinerator? Thank you
(answered 03/30/2006)
what is the recommended method for quality control of id sytems, ie api, vitek, microscan etc. are maufacturers recommended qc organsims sufficiet or do we need to find organisms that will test the positive and negative reactions for each well of the id system.
(answered 02/27/2006)
Is N. gonorrheoeae sufficient to monitor CO2 or additionally H. influenzae daily subcultures requirred? And how often must new subcultures from frozen stock made?
(answered 02/23/2006)
Is there a reference for finding appropriate ATCC strains for QC (finding a strain that is positive or negative for a specific test)? There is a new CAP question that states each biochemical reaction in a bacterial id system should be tested with a positive and negative organism. How can this be achieved easily and cost effectively (we use the Vitek2)?
(answered 02/21/2006)
When sterile product is filtered through .22 micron filter then Why sterility testing is done by using .45 micron filter?
(answered 02/08/2006)
what is considered parallel testing? Is it the concurrent running of a the same specimen by different methodes? Or the same specimen is run on consecutive days by the two methodes? What you are same volume facility that is changing methodes, can a specimen be obtained from a reference lab, with known results, that would run at your facility? Would this be sufficient to validate the new method? Or does the reference specimen also have to be run by your current method as well as the new methode?
(answered 11/23/2005)
If a QC organism with a specific ATCC number is recommended for checking either a biochemical reaction or media but another ATCC strain is used, am I still in compliance? For example, we use either SMAC with tellurite or Chromagar O157. We have the recommended ATCC strain of E. coli O157 for the SMAC with tellurite but the Chromagar recommends another. We have used the SMAC w/ tellurite strain successfully with the Chromagar. Must I buy a second expensive organism. Thank you
(answered 09/09/2005)
Why is there a recommendation to fix AFB smears for at least 2 hours with heat but not respiratory samples for gram stain? Does the concentration of the sample for AFB make the slide that much more infectious?
(answered 08/11/2005)
In the CLSI M22-A3 standard for Quality Control of Culture Media Table 1B, Middlebrook agar is listed in the Exempt column and Middlebrook 7H10 & 7H11 are listed in the Nonexempt column. I am trying to clarify the need for user labs to perform their own QC on commercially prepared Middlebrook 7H11 and selective 7H11 media. What is the distinction between the two listings for Middlebrook agar? If QC is required for users of commercially prepared media, the listed control organisms in Table 2 are rather extensive (6 organisms including M. tuberculosis). Are all required and is direct inoculation acceptable for both CLSI & CAP? Also what should be the user protocol used for fungal isolation media not listed such as Mycosel and Sabhi? Thank you for your help.
(answered 08/10/2005)
1. How many day of shelf life of sheep blood Alsever and defribriated sheep blood? (storage at 2 - 8 degree C.) 2. What is the cause of hemolysis and blood clot in sheep blood Alsever(standard preparation) after preparation for 2 - 3 days before treat with any process? Thank you. National Laboratory Animal Center, Mahidol University, Thailand.
(answered 08/08/2005)
CAP survey question MIC.61550 states" Are the results of controls reviewed for acceptability before reporting patient results?" In regards to tests with an internal control (like a dot or line as positive and a clear background as a negative) One inspector thinks that this means a log must be kept with the internal control results for each patient individually. I do not agree with this interpretation. I think the questions applies to external controls and it is assumed one does not report out results if internal controls fail as is stated in the SOP.
(answered 07/20/2005)
Can someone explain the rational behind Q.C. of india ink with positive and negative controls? Every time we set one up, we observe for a smooth suspension of india ink particles and proper thickness to insure being able to view cells (and capsules if present)in the prep. A known positive and negative could only serve if we didn't know what we were looking for. Is this the rational?
(answered 06/30/2005)
CO2 QC question: we run the fyrite weekly and do a daily CO2 reading. Do we also have to sub G.C. daily for viability?
(answered 06/29/2005)
QUESTION: I recently took a section head position in a microbiology laboratory in a smaller hospital. I want to the find the most recent recomendations for frequency (daily, monthly,upon use,etc.)of Quality Control testing for a gammut of microbiology tests. Tests ranging from PYR, latex (STREPTEX) Strep typing reagents, Salmonella / Shigella antisera, various stains, and so on. What resources are available and is there a checklist or cheat sheet available?
(answered 04/25/2005)
I recently took a section head position in a microbiology laboratory in a smaller hospital. I want to the find the most recent recomendations for frequency of testing for a gammut of microbiology tests. Tests ranging from PYR, latex (STREPTEX) Strep typing reagents, Salmonella / Shigella antisera, various stains, and so on. What resources are available and is there a checklist or cheat sheet available?
(answered 04/21/2005)
I worked in a microbiology lab that froze QC organisms as well as Positive Identified cultures using defibrinated sheeps blood and then storing them at -70,and we were able to revive these organisms for future uses. I have been unable to find a reference for this technique. Can you help?
(answered 04/20/2005)
What the purpose to use Evans Blue Dye method in calibration of loops used in streaking plates in Microbiology routine?
(answered 03/07/2005)
We perform the Remel Selective Rapid Urea for H.pylori. We now need to do a proficiency and can not find one. What do we do in this case? Since the specimen is a biopsy it would be unlikely to be able to do it in duplicate.
(answered 01/27/2005)
I work in a drinking water lab and must test a known positive organism and a known negative organism with each lot number of media purchased. We presently using commercially prepared ATCC strains of E.coli, Ps. aeruginosa, K. pneumonia and E. aerogenes. In order to save money, would it be possible to transfer the organisms in tryptic soy broth to save for future use instead of always using a fresh freeze-dried sample? If so, how often should they be transfered to maintain a pure culture?
(answered 01/24/2005)
PLEASE HELP! RE: Performing QC for bacterial contamination on platelet products with automated instrument that is not FDA-approved for this purpose. Could you please provide the most recent authoritative references for the microbiology lab? In anticipation of having to provide this service to our blood bank (most likely only for apheresis platelets & stem cells): 1) what is the requirement for validating our automated blood culture instrument (VersaTrek, not FDA approved for this)? 2) What specific protocol should or could be followed for validation? What degree of automated culture concordance with known spiked product is acceptable for validation? Should the study parameters be different for leukoreduced vs. non-leukoreduced platelets? 3)What is a recommended protocol for the actual QC cultures? Inoculation volume, Incubation time? Blind/terminal subculture criteria? etc. 4) What about QC on progenitor stem cells? Should a separate procedure be validated for this, or is the procedure used for routine blood culture acceptable? 5) To validate a QC dipstick method I assume one needs to compare dipstick to agar culture growth if the automated blood instrument is not yet validated? 6) Some folks ask: for transfusion reactions involving platelets, the platelet product is cultured on the automated instrument -- why is platelet culture allowed on the instrument without validation in this context???
(answered 01/17/2005)
The manufacturer's package insert in the API gram-negative test kit says to perform QC using E. coli 25922 OR one of the following strains (4 other QC organisms are listed). Would it be acceptable to run one organism and get an acceptable result or is it still recommended that we do QC to obtain a positive and negative reaction for each well in the test strip? Thank you.
(answered 01/13/2005)
I work in a 150 bed Community Hospital and am interested in cancellation guidelines for various types of Microbiology specimens. For example, we have recently implemented cancellation criteria for stool specimens for Clostridium difficile toxin (from ASM "Ask It") and would like to establish criteria for all of our specimens. Is there a place I would be able to find this info?
(answered 12/27/2004)
Can you please tell me how long should qc records be kept?how long should calibrations for bac t alert instrument be kept?Is 2 years sufficient for all types of qc such as weekly testing for vitek cards? thank you
(answered 10/08/2004)
What is the recommended QC for the novobiocin susceptibility test (5 ug) to identify S. saprophyticus?
(answered 10/08/2004)
i would be very gratefull if you could provide me information about maintaining quality control records and the proceedures (both for antibiotic Q.C. and for the various instruments in a microbiology laboratory in a hospital,could you also provide me a few refrence sites for it too? thanks a lot.
(answered 09/16/2004)
Is there any procedure on how to perform quality assurance in the Microbilogy Lab? Also I need examples
(answered 09/24/2004)
What is the optimal CO2 concentration for routine clinical micrabiology in a C02 incubator? In our lab I use 5 %. This concentration is monitored permanently on a display and verified once a year (calibration). Our accreditation organisation has some remarks about this procedure. They want that we incubate every day an organism that needs CO2 as quality control of the whole proces. Does anyone knows such an organism (do not mention Neiserria gonorrhoeae or Haemophilus, because the ATCC strains we obtained also grow without C02)? Second question : the precision of 5 % C02 is 0.3 % (manufacturer). The same organisation want us to verity that this deviation has no impact on our isolations. What is your opinion about this ?
(answered 08/05/2004)
I am re-writing our laboratory's procedure on reagent water testing. NCCLS guidelines (C3-A3) recommend bacterial counts weekly. We do counts on our type I water weekly and type II monthly using the pour plate method. My questions are: should type II water be assayed weekly for bacterial counts? The guidelines refer to commerically available enumeration kits. Can you please tell me where to find information on such kits? The pour plate method is tedious.
(answered 07/14/2004)
Regarding CAP compliance with reagent QC (MIC.21630)--do PYR disks and a rapid ID of C. albicans (using Remel C albicans screen kit) fall under the categories of identification systems (to switch to new batch/lot/shipement from our current daily QC)? Sodium deoxycholate (bile solubility) is not listed so am I to assume that is still day of use? ID disks for anaerobes are not listed; we use bile, colistin, kanamcyin and vancomycin are perform QC weekly. I assume this is "unchanged" under the revised checklist. Thanks for your help.
(answered 07/02/2004)
According to NCCLS M22-P2 exempt media include Mannitol Salt agar and selective media for Enterococci w/wo azide. Does this include mannitol salt agar with oxacillin and bile esculin agar with vancomycin? We presently perform QC on each new lot/shipment. We use bile esculin slants and a heart infusion broth w/ 6.5 NaCl to differentiate nonenterococcus from enterococcus. Would these fall into the exempt category as well? Thanks for your help.
(answered 07/02/2004)
What is the recommended procedure for sterility checks on chocolate, Thayer-Martin, and Campylobacter media?
(answered 06/16/2004)
Indole is not included in the list for daily QC to QC for each batch or each lot number or shipment. Do I assume that Indole is to be treated the same way as coagulase, oxidase, etc.??
(answered 05/03/2004)
What are the guidelines for evaluating in-house media lots for suitability in a laboratory?
(answered 04/22/2004)
What is the acceptable room temp range for micro media kept on a counter, i.e. BAP, MAC, CHOC,thio, chopped meat broth, we were given 20+/- 2 deg C?
(answered 03/23/2004)
I have completed a quality assurance study on gram stain results compared to culture results. Is there a standard for the comparison?
(answered 08/04/2003)
In relation to Quality Control testing: What is the definition of "batch"? For example, if we receive a "box" of oxidase product (which would be the Lot#/Shipment requirement for testing), that has envelopes with 4 test strips inside each, Would each envelope be considered a batch? Each test strip would not be considered a batch? Or would the "batch" be a second BOX, if we had ordered 2 boxes?
(answered 05/07/2003)
How many times should ATCC strains (already in the 4th subculture) be safely passaged onto further subcultures without affecting their stability and biochemical profiles (e.g., Enterococcus faecalis ATCC 29212), for QC purposes? Would numerous subculturing adversely affect the stability of QC organisms?
(answered 03/04/2003)
When recording quality control results for media and reagent testing, is it acceptable to use quotation marks to denote the same lot number as previously written? Must the specific observation (a color change recorded as BLUE) be recorded for a quality control test or can POSTIVE or ACCEPTED be used as responses?
(answered 01/29/2003)
We are considering adding the binaxNow test for Legionella. How often is it required to run the external controls to meet CAP regulations. Binax says only when a new lot of kit is opened. 
(answered 12/03/2002)
To test the saline I use for the Vitek dilutions, I put some in thio and check for growth for two days. Is this acceptable? Also, to test the distilled water I do the same. I think I need to do colony counts rather than just growth or no growth. Is this correct? If you have a procedure you could forward to me I would appreciate it. NCCLS document C3-A3 doesn't go into enough detail.
(answered 07/11/2002)
I am a new supervisor in the microbiology lab in a small community hospital. I noticed that QC is not being done on Mac with Sorbitol, Lim Broth and Ox Screen Agar. I believe that all of these do need to be QC'd. Am I correct? What are the QC organisms that should be used?
(answered 07/10/2002)

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