[Histonet] received dates no longer required

[Teri Johnson]

As of January 2016, the updated NY State Dept of Health standards still require received date, and date the material is placed in service or opened:

Reagents Sustaining Standard of Practice 4 (REAG S4): Inventory Control
There shall be an inventory control system for supplies. This system should
include the recording of lot numbers and expiration dates of all relevant
reagents, control materials, and calibrators; the date of receipt in the laboratory;
the date of performance verification and the date the material is placed in
service. All of these quality records shall be available for laboratory
management and Department review. -AND-

Reagents Sustaining Standard of Practice 5 (REAG S5): Labeling
Reagents, solutions, culture media, control materials, calibration materials, and
other supplies, as appropriate, must be labeled to indicate the following:
a) identity;
b) titer, strength or concentration as applicable;
c) storage conditions;
d) preparation date or date opened and the identity of the preparer;
e) unopened and opened expiration date if pertinent to the performance of
the reagent; and,
f) other relevant information.

So if you have NY certification, you will still need to do this practice. An inspector could argue that f) other relevant information could include received date.

Best wishes,

Teri Johnson
Manager, Clinical Trial Testing
Genoptix, Inc., a Novartis company
BioPharma
1811 Aston Avenue
Carlsbad, CA  92008
USA

Phone +1 760 516 5954
tejohnson at genoptix.com
www.genoptix.com




Message: 1
Date: Sat, 9 Jan 2016 11:06:03 -0800
From: Cheryl <tkngflght at yahoo.com>
To: histonet at lists.utsouthwestern.edu
Subject: [Histonet] received dates no longer required
Message-ID: <03D9FBAE-53EB-4367-B5E5-6A5FD2107997 at yahoo.com>
Content-Type: text/plain;charset=us-ascii

Hi guys-

I'm probably coming in a little late to this conversation.  Received dates are no longer required by any of the governing bodies. Haven't been for a while.  Opened dates aren't required either, as long as the reagent's performance isn't altered by the mechanical act of opening the container (this does apply to some clinical reagent's and almost no histology supplies when stored correctly)

The only required date is expiry.  If on the rare instance the manufacturer doesn't supply one, your institution would need to decide what works (1 year up to as many as 5 years) and include this statement in a policy. Then and only then would you need to mark the incoming supply with the received and internally determined expiration date.

To complete the variables that may come up- we can no longer extend and expiration by freezing. This used to be a common practice for concentrated antibodies to extend expiration, but no more.

Take a minute and look it up for CAP, JCACO and all the others-- it'll save you SO much time -- don't forget to update your policies so you're not breaking your own internal guidelines.

The only reason I can think of to date everything is if folks don't reliably rotate stock-- and even if they are-- if your supplier isn't doing it well, your applied dates might not line up with first expired--

Thoughts?

Cheryl





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