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  Deteriorated or outdated reagents and solutions shall not 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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