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Lynn Gerber
medicine forum beginner
Joined: 13 Jun 2005
Posts: 1
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 Posted: Mon Jun 13, 2005 1:39 am Post subject:
Microbiologists, question regarding API 20E QC
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Our lab recently had a COLA accreditation survey. The surveyor said that QC
of API 20E strips (using stock organisms) should be done WEEKLY. That
didn't and doesn't sound right. I called Biomerieux and they indicated that
once each lot number/shipment is sufficient. I asked for a reference, and
the tech support person said it was found in NCCLS document M02-A8. When I
read the description of that document, it sounds like it mainly pertains to
susceptability testing. I tried contacting NCCLS/CLSI via e-mail, but they
have yet to get back with me.
Any ideas?
Historically, our lab has been surveyed by CAP and JCAHO and most recently
COLA. I've never heard of this as a deficiency before. We had been doing
the QC monthly for years and this has never been a deficiency. |
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Katra
medicine forum addict
Joined: 06 May 2005
Posts: 80
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| Posted: Mon Jun 13, 2005 2:05 am Post subject:
Re: Microbiologists, question regarding API 20E QC
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In article <11apvvi6l9tsu55@corp.supernews.com>,
"Lynn Gerber" <lgerber@cableone.net> wrote:
| Quote: | Our lab recently had a COLA accreditation survey. The surveyor said that QC
of API 20E strips (using stock organisms) should be done WEEKLY. That
didn't and doesn't sound right. I called Biomerieux and they indicated that
once each lot number/shipment is sufficient. I asked for a reference, and
the tech support person said it was found in NCCLS document M02-A8. When I
read the description of that document, it sounds like it mainly pertains to
susceptability testing. I tried contacting NCCLS/CLSI via e-mail, but they
have yet to get back with me.
Any ideas?
Historically, our lab has been surveyed by CAP and JCAHO and most recently
COLA. I've never heard of this as a deficiency before. We had been doing
the QC monthly for years and this has never been a deficiency.
|
If you are CAP accredited, why do you need a second inspection by COLA?
I've never heard of them?
--
K.
Sprout the MungBean to reply
"I don't like to commit myself about heaven and hell‹you
see, I have friends in both places." --Mark Twain |
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JEDilworth
medicine forum addict
Joined: 06 May 2005
Posts: 87
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| Posted: Mon Jun 13, 2005 3:31 am Post subject:
Re: Microbiologists, question regarding API 20E QC
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I've worked in clinical micro for nearly 30 years and I've never worked
anywhere that QC'd API's weekly. The expense would be mind-boggling, as
you have to have a positive and negative for every well. We QC upon
receipt only. Same with Vitek GNI cards - upon receipt only. When I
worked in a private lab we used Crystal ID as a backup ID system -
again, upon receipt only, and we were also CAP accredited. Our
pathologist there was, at one time, the head honcho at CAP, so we did
everything exactly by the book. Is there some reason you're doing it
monthly? I suppose if we had problems with the strips we would repeat QC
in that case. We are a CAP accredited laboratory, and perform the micro
work for four hospitals.
Susceptibility testing is done on a weekly basis, both Kirby-Bauer and
Vitek.
Judy Dilworth, M.T. (ASCP)
Microbiology
"Lynn Gerber" <lgerber@cableone.net> wrote in message
| Quote: | Our lab recently had a COLA accreditation survey. The surveyor said
that QC
of API 20E strips (using stock organisms) should be done WEEKLY. |
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Dave L
medicine forum beginner
Joined: 13 Jun 2005
Posts: 19
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| Posted: Mon Jun 13, 2005 4:52 am Post subject:
Re: Microbiologists, question regarding API 20E QC
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"Lynn Gerber" <lgerber@cableone.net> wrote in
news:11apvvi6l9tsu55@corp.supernews.com:
| Quote: | Our lab recently had a COLA accreditation survey. The surveyor said
that QC of API 20E strips (using stock organisms) should be done
WEEKLY. That didn't and doesn't sound right. I called Biomerieux and
they indicated that once each lot number/shipment is sufficient. I
asked for a reference, and the tech support person said it was found
in NCCLS document M02-A8. When I read the description of that
document, it sounds like it mainly pertains to susceptability testing.
I tried contacting NCCLS/CLSI via e-mail, but they have yet to get
back with me.
|
Different accreditation and continent, but we don't QC them at all.
Biomerieux are ISO certified for production and on request will supply QC
certificates for each batch.
If you QC where do you stop, positive and negative controls for each well?
Even if you put a know Salmonella or E. coli through that won't prove that
another strain or organism won't produce a wrong ID. Plus do you QC the
reagents?
Presumably you regularly use APIs for EQA samples and as long as these ID
satisfactorily then this demonstates and on going suitability and as
Biomerieux are certified to produce a consistant product that should be
sufficient.
Dave |
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Mike McWilliams
medicine forum beginner
Joined: 13 Jun 2005
Posts: 43
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| Posted: Mon Jun 13, 2005 1:53 pm Post subject:
Re: Microbiologists, question regarding API 20E QC
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Lynn Gerber wrote:
| Quote: | Our lab recently had a COLA accreditation survey. The surveyor said that QC
of API 20E strips (using stock organisms) should be done WEEKLY. That
didn't and doesn't sound right. I called Biomerieux and they indicated that
once each lot number/shipment is sufficient. I asked for a reference, and
the tech support person said it was found in NCCLS document M02-A8. When I
read the description of that document, it sounds like it mainly pertains to
susceptability testing. I tried contacting NCCLS/CLSI via e-mail, but they
have yet to get back with me.
Any ideas?
Historically, our lab has been surveyed by CAP and JCAHO and most recently
COLA. I've never heard of this as a deficiency before. We had been doing
the QC monthly for years and this has never been a deficiency.
I would think that testing once each lot number was appropriate. Why |
arbitrarily weekly or monthly? Neither makes any sense to me. I suppose
maybe they thought a month was too lax and somehow weekly would be better.
At least lot testing is bounded in reality. |
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JEDilworth
medicine forum addict
Joined: 06 May 2005
Posts: 87
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| Posted: Mon Jun 13, 2005 3:27 pm Post subject:
Re: Microbiologists, question regarding API 20E QC
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That would be nice to do, but CAP mandates QC on receipt. I think we QC
reagents on receipt but I'm not sure. Our QC is spread out and different
techs are responsible for different things as there's way too much for
one person to handle.
Judy Dilworth, M.T. (ASCP)
Microbiology
"Dave L" <dave_the_glammy_fan@yahoo.com> wrote in message
news:I2are.7551$a5.1746@newsfe5-win.ntli.net...
| Quote: |
Different accreditation and continent, but we don't QC them at all.
Biomerieux are ISO certified for production and on request will supply
QC
certificates for each batch. |
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John Gentile
medicine forum beginner
Joined: 30 Apr 2005
Posts: 40
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| Posted: Mon Jun 13, 2005 6:50 pm Post subject:
Re: Microbiologists, question regarding API 20E QC
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in article 11apvvi6l9tsu55@corp.supernews.com, Lynn Gerber at
lgerber@cableone.net wrote on 6/13/05 3:39 AM:
| Quote: | Our lab recently had a COLA accreditation survey. The surveyor said that QC
of API 20E strips (using stock organisms) should be done WEEKLY. That
didn't and doesn't sound right. I called Biomerieux and they indicated that
once each lot number/shipment is sufficient. I asked for a reference, and
the tech support person said it was found in NCCLS document M02-A8. When I
read the description of that document, it sounds like it mainly pertains to
susceptability testing. I tried contacting NCCLS/CLSI via e-mail, but they
have yet to get back with me.
|
The A2 NCCLS document only applies to sensitivity testing. QC of bundled
kits is still recommended at once per lot. It sounds like the surveyor
doesn't understand NCCLS or CAP.
--
John Gentile Editor, Rhode Island Apple Group
yjgent@cox.net RIAG Web page: www.wbwip.com/riag/
"I never make mistakes, I only have unexpected learning opportunities!" |
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Dave L
medicine forum beginner
Joined: 13 Jun 2005
Posts: 19
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| Posted: Sun Jun 19, 2005 7:49 am Post subject:
Re: Microbiologists, question regarding API 20E QC
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"JEDilworth" <bactitech@nospamhortonsbay.com> wrote in
news:5ridncRF_NpEXDDfRVn-1g@buckeye-express.com:
| Quote: | That would be nice to do, but CAP mandates QC on receipt.
|
I've just had a very quick flick through the CAP manual
"New lots of reagent must be checked
against old lots, or with suitable reference material, before or
concurrently with being placed into service."
Has anyone tried arguing that where it says "before" could refer to the QC
carried out by the manuafacturer?
Dave |
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John Gentile
medicine forum beginner
Joined: 30 Apr 2005
Posts: 40
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| Posted: Tue Jun 21, 2005 9:42 pm Post subject:
Re: Microbiologists, question regarding API 20E QC
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Micro ID systems are just that - they are not "reagents". The requirements
for comparing lot to lot refer to diagnostic tests that give verifiable
numbers that can be compared using the 2 lots. The manufacturer's
recommendation for ID QC is what pertains to micro. I even went to a lecture
given by the micro QC person at CDC and he was trying to recommend setting
up 2 controls - a saline blank for negative and a combination of organisms
(a soup) that would give all positive results. All you are interested in is
seeing that the kit is capable of giving the appropriate POS or NEG
reaction, NOT that it can identify a QC organism.
--
John Gentile MS M(ASCP) yjgent@cox.net
Laboratory Information, QA Manager
VA Medical Center
Providence, RI
The contents of this message are mine personally and do not reflect any
position of the Government or VA.
in article gcbte.24326$a5.13741@newsfe5-win.ntli.net, Dave L at
dave_the_glammy_fan@yahoo.com wrote on 6/19/05 9:49 AM:
| Quote: | "JEDilworth" <bactitech@nospamhortonsbay.com> wrote in
news:5ridncRF_NpEXDDfRVn-1g@buckeye-express.com:
That would be nice to do, but CAP mandates QC on receipt.
I've just had a very quick flick through the CAP manual
"New lots of reagent must be checked
against old lots, or with suitable reference material, before or
concurrently with being placed into service."
Has anyone tried arguing that where it says "before" could refer to the QC
carried out by the manuafacturer?
Dave |
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Dave L
medicine forum beginner
Joined: 13 Jun 2005
Posts: 19
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| Posted: Wed Jun 22, 2005 12:34 pm Post subject:
Re: Microbiologists, question regarding API 20E QC
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John Gentile <yjgent@cox.net> wrote in
news:BEDE5651.1A21C%yjgent@cox.net:
| Quote: | Micro ID systems are just that - they are not "reagents". The
requirements for comparing lot to lot refer to diagnostic tests that
give verifiable numbers that can be compared using the 2 lots. The
manufacturer's recommendation for ID QC is what pertains to micro. I
even went to a lecture given by the micro QC person at CDC and he was
trying to recommend setting up 2 controls - a saline blank for
negative and a combination of organisms (a soup) that would give all
positive results. All you are interested in is seeing that the kit is
capable of giving the appropriate POS or NEG reaction, NOT that it can
identify a QC organism.
|
The applicable requirement would to be to check with suitable reference
material.
As I said before what you'd need to do for an API to have any true meaning
is positive and negative reactions for each well.
Having an all pos soup wouldn't tell you for example if it was the
Salmonella that gave you a positive ONPG.
If you wanted to get really silly you'd have to QC each reagent separately
from the test strip because if there was a unexpected reaction you wouldn't
know if it were the reagent or the strip.
You'd have to show that the mineral oil was sterile and didn't have any
effect on the test etc etc.
I can't see where it says the lab must do the testing just that it must be
done before being placed into use. To me that could be the supplier's QC
Dave
Dave |
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N10
medicine forum beginner
Joined: 25 Jun 2005
Posts: 8
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| Posted: Sat Jun 25, 2005 11:07 am Post subject:
Re: Microbiologists, question regarding API 20E QC
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"Dave L" <dave_the_glammy_fan@yahoo.co.uk> wrote in message
news:lGeue.138$5D4.135@newsfe4-win.ntli.net...
| Quote: | John Gentile <yjgent@cox.net> wrote in
news:BEDE5651.1A21C%yjgent@cox.net:
Micro ID systems are just that - they are not "reagents". The
requirements for comparing lot to lot refer to diagnostic tests that
give verifiable numbers that can be compared using the 2 lots. The
manufacturer's recommendation for ID QC is what pertains to micro. I
even went to a lecture given by the micro QC person at CDC and he was
trying to recommend setting up 2 controls - a saline blank for
negative and a combination of organisms (a soup) that would give all
positive results. All you are interested in is seeing that the kit is
capable of giving the appropriate POS or NEG reaction, NOT that it can
identify a QC organism.
The applicable requirement would to be to check with suitable reference
material.
As I said before what you'd need to do for an API to have any true meaning
is positive and negative reactions for each well.
Having an all pos soup wouldn't tell you for example if it was the
Salmonella that gave you a positive ONPG.
If you wanted to get really silly you'd have to QC each reagent separately
from the test strip because if there was a unexpected reaction you
wouldn't
know if it were the reagent or the strip.
You'd have to show that the mineral oil was sterile and didn't have any
effect on the test etc etc.
I can't see where it says the lab must do the testing just that it must be
done before being placed into use. To me that could be the supplier's QC
Dave
Dave
|
Hi Dave
A relevant point is whether or not the the manufactuirer of the kit is
accredited to any Internatioanlly recognised standard such as
the various ISO, UKAS local relevant systems.
If so then given adhearance to the requirments of maintaing accredidation
to such a scheme I see no need regulary run reagent checks or positive
controls providing adequate QC certification has been provided by the
manufacturer.
If the alternate is true then you have no assurance of quality etc etc
N10 |
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Dave L
medicine forum beginner
Joined: 13 Jun 2005
Posts: 19
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| Posted: Sun Jun 26, 2005 11:32 am Post subject:
Re: Microbiologists, question regarding API 20E QC
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|
"N10" <limbic_lesion@hotmail.com> wrote in
news:d9jdtj$2u2$1@nwrdmz01.dmz.ncs.ea.ibs-infra.bt.com:
| Quote: |
"Dave L" <dave_the_glammy_fan@yahoo.co.uk> wrote in message
news:lGeue.138$5D4.135@newsfe4-win.ntli.net...
John Gentile <yjgent@cox.net> wrote in
news:BEDE5651.1A21C%yjgent@cox.net:
Micro ID systems are just that - they are not "reagents". The
requirements for comparing lot to lot refer to diagnostic tests that
give verifiable numbers that can be compared using the 2 lots. The
manufacturer's recommendation for ID QC is what pertains to micro. I
even went to a lecture given by the micro QC person at CDC and he
was trying to recommend setting up 2 controls - a saline blank for
negative and a combination of organisms (a soup) that would give all
positive results. All you are interested in is seeing that the kit
is capable of giving the appropriate POS or NEG reaction, NOT that
it can identify a QC organism.
The applicable requirement would to be to check with suitable
reference material.
As I said before what you'd need to do for an API to have any true
meaning is positive and negative reactions for each well.
Having an all pos soup wouldn't tell you for example if it was the
Salmonella that gave you a positive ONPG.
If you wanted to get really silly you'd have to QC each reagent
separately from the test strip because if there was a unexpected
reaction you wouldn't
know if it were the reagent or the strip.
You'd have to show that the mineral oil was sterile and didn't have
any effect on the test etc etc.
I can't see where it says the lab must do the testing just that it
must be done before being placed into use. To me that could be the
supplier's QC
Dave
Dave
Hi Dave
A relevant point is whether or not the the manufactuirer of the kit
is accredited to any Internatioanlly recognised standard such as
the various ISO, UKAS local relevant systems.
If so then given adhearance to the requirments of maintaing
accredidation to such a scheme I see no need regulary run reagent
checks or positive controls providing adequate QC certification has
been provided by the manufacturer.
If the alternate is true then you have no assurance of quality etc
etc
|
I've already said this, but apparently under CAP accreditation ISO means
nothing and you still have to do in house checks.
Dave |
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N10
medicine forum beginner
Joined: 25 Jun 2005
Posts: 8
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| Posted: Mon Jun 27, 2005 10:43 pm Post subject:
Re: Microbiologists, question regarding API 20E QC
|
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|
"Dave L" <dave_the_glammy_fan@yahoo.co.uk> wrote in message
news:X7yve.10637$BD2.9327@newsfe1-gui.ntli.net...
| Quote: | "N10" <limbic_lesion@hotmail.com> wrote in
news:d9jdtj$2u2$1@nwrdmz01.dmz.ncs.ea.ibs-infra.bt.com:
"Dave L" <dave_the_glammy_fan@yahoo.co.uk> wrote in message
news:lGeue.138$5D4.135@newsfe4-win.ntli.net...
John Gentile <yjgent@cox.net> wrote in
news:BEDE5651.1A21C%yjgent@cox.net:
Micro ID systems are just that - they are not "reagents". The
requirements for comparing lot to lot refer to diagnostic tests that
give verifiable numbers that can be compared using the 2 lots. The
manufacturer's recommendation for ID QC is what pertains to micro. I
even went to a lecture given by the micro QC person at CDC and he
was trying to recommend setting up 2 controls - a saline blank for
negative and a combination of organisms (a soup) that would give all
positive results. All you are interested in is seeing that the kit
is capable of giving the appropriate POS or NEG reaction, NOT that
it can identify a QC organism.
The applicable requirement would to be to check with suitable
reference material.
As I said before what you'd need to do for an API to have any true
meaning is positive and negative reactions for each well.
Having an all pos soup wouldn't tell you for example if it was the
Salmonella that gave you a positive ONPG.
If you wanted to get really silly you'd have to QC each reagent
separately from the test strip because if there was a unexpected
reaction you wouldn't
know if it were the reagent or the strip.
You'd have to show that the mineral oil was sterile and didn't have
any effect on the test etc etc.
I can't see where it says the lab must do the testing just that it
must be done before being placed into use. To me that could be the
supplier's QC
Dave
Dave
Hi Dave
A relevant point is whether or not the the manufactuirer of the kit
is accredited to any Internatioanlly recognised standard such as
the various ISO, UKAS local relevant systems.
If so then given adhearance to the requirments of maintaing
accredidation to such a scheme I see no need regulary run reagent
checks or positive controls providing adequate QC certification has
been provided by the manufacturer.
If the alternate is true then you have no assurance of quality etc
etc
I've already said this, but apparently under CAP accreditation ISO means
nothing and you still have to do in house checks.
Dave
|
Hi Dave :}
Im getting a strong sense of impending DOOM looming here, as the
prospective work load in your lab plummets into an endless abyss of
verification upon verification. I can offer no further help, only
condolencies, for as you correctly state the accreditation Standard you seek
to accquire does state that in house checks must be done as you describe. I
guess if you want the acrreditation then you will have to comply with the
standard. I guess yourr lucky you dobnt use 50 CHs lol
Best N10 |
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Dave L
medicine forum beginner
Joined: 13 Jun 2005
Posts: 19
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| Posted: Tue Jun 28, 2005 2:42 am Post subject:
Re: Microbiologists, question regarding API 20E QC
|
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| Quote: | Hi Dave :}
Im getting a strong sense of impending DOOM looming here, as the
prospective work load in your lab plummets into an endless abyss of
verification upon verification. I can offer no further help, only
condolencies, for as you correctly state the accreditation Standard
you seek to accquire does state that in house checks must be done as
you describe. I guess if you want the acrreditation then you will have
to comply with the standard. I guess yourr lucky you dobnt use 50
CHs lol
You're probably missing the whole thread. |
Luckily I've got nothing to do with this accreditation, I was just
answering a question.
UKAS don't seem so bad now ;-)
Dave |
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N10
medicine forum beginner
Joined: 25 Jun 2005
Posts: 8
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| Posted: Tue Jun 28, 2005 8:17 am Post subject:
Re: Microbiologists, question regarding API 20E QC
|
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|
"Dave L" <dave_the_glammy_fan@yahoo.co.uk> wrote in message
news:Ky4we.14323$BD2.10566@newsfe1-gui.ntli.net...
| Quote: | Hi Dave :}
Im getting a strong sense of impending DOOM looming here, as the
prospective work load in your lab plummets into an endless abyss of
verification upon verification. I can offer no further help, only
condolencies, for as you correctly state the accreditation Standard
you seek to accquire does state that in house checks must be done as
you describe. I guess if you want the acrreditation then you will have
to comply with the standard. I guess yourr lucky you dobnt use 50
CHs lol
You're probably missing the whole thread.
Luckily I've got nothing to do with this accreditation, I was just
answering a question.
UKAS don't seem so bad now ;-)
Dave
|
THAnks Dave
My news reader is a bit patchy for some unknowable reason so I agree I
probabley have missed quite alot of the thread, that often happens.
Glad its all resolved and I agree UKAS are just dandy.
Best Des |
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