Re: Regulations
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From: | MTBowers@aol.com |
To: | JWEEMS@sjha.org, histonet@pathology.swmed.edu |
Reply-To: | |
Content-Type: | text/plain; charset="US-ASCII" |
In a message dated 04/24/2000 7:14:50 AM Pacific Daylight Time,
JWEEMS@sjha.org writes:
> I was looking for written proof of how we are required to initial and date
> our reagents. I could not find them in our CAP guidelines (Anatomic
> Pathology). I searched the General Lab guidelines - no luck. Why are these
> included in each department except ours? Does this mean that we really
don't
> have to date and initial?
This is covered in a couple areas and is somewhat redundant. 42 CFR is the
Health Care Finance Administration's area of laboratory regulation. 21 CFR
is the Food and Drug Administration's area for GLP (Good Laboratory Practice)
regulation.
Here is a brief look at both of the CFR's
"42 CFR Ch. IV, SUBPART J, SECTION 493.1205
STANDARD; TEST METHODS, EQUIPMENT, INSTRUMENTATION, REAGENTS, MATERIALS, AND
SUPPLIES
The laboratory must utilize test methods, equipment, instrumentation,
reagents, materials, and supplies that provide accurate and reliable test
results and test reports...
...(d) Reagents, solutions, culture media, control materials, calibration
materials and other supplies, as appropriate, must be labeled to indicate-
(1) Identity and, when significant, titer, strength or concentration;
(2) Recommended storage requirements;
(3) Preparation and expiration dates;
(4) Other pertinent information required for proper use...
SECTION 493.1211
STANDARD; PROCEDURE MANUAL"
Also has some relevant data.
"21 CFR, SUBPART E -- TESTING FACILITIES OPERATION
SECTION 58.83 -- REAGENTS AND SOLUTIONS
All reagents and solutions in the laboratory areas shall be labeled to
indicate identity, titer or concentration, storage requirements, and
expiration date. Deteriorated or outdated reagents and solutions shall not
be used."
Many chemicals in the laboratory such as powdered stains and chemicals have
no known expiration dates (provided they have been stored properly). For
these, it is acceptable to put 'NONE' provided you can back it up with either
literature references, efficacy testing or laboratory experience.
In our lab, I have all staining solutions (with the exception of our immunos)
made from scratch. No kits. We follow the GLP guidelines and have never
been dinged.
I hope this aids your search for answers.
Matt Bowers
Lab Manager
Visalia Path Med Grp
126 S Floral
Visalia, CA
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