Part 1 - PulseNet International

testing meet necessary quality control requirements. Stringent specifications for these
materials shall be developed, and adherence to the specifications must be mandatory.
F.3.1
The laboratory shall have written procedures for documenting commercial supplies
and for the formulation of reagents (PNL01 & PNL02).
F.3.1.1
All commercially available reagents shall have a quality assurance certificate
issued by the supplier, a record of which shall be maintained by the laboratory.
F.3.2
Reagents shall be labeled with the identity of the reagent, storage requirements, titer
or concentration, the date of preparation or expiration, and the identity of the
individual preparing the reagent. Deteriorated or outdated reagents and solutions shall
not be used.
F.3.3
Reagent solutions prepared “in-house” shall have their expiration dates established by
the laboratory. A program of periodic testing shall be instituted to determine that
reagents/solutions have not deteriorated.
F.3.4
When establishing reagent preparation as a laboratory function, the methods used
shall be accurately and completely described in writing. There shall be documentation
of each lot prepared, including reagent lots and expiration dates, date prepared,
initials of personnel preparing reagent and expiration date of prepared reagent.
F.3.5
Reagents shall remain free of contamination, either chemical or microbiological.
F.3.6
Proper physical conditions of storage shall be carefully maintained. Reagents shall be
maintained at the temperatures recommended by the manufacturer. Reagents
maintained under refrigerated or freezing temperatures, such as proteinase K and
restriction enzymes/buffers, shall not be removed from the storage conditions until
ready to use. These reagents shall be maintained at the appropriate temperature(s)
following manufacturer’s guidelines while in use, and shall be returned to proper
storage conditions promptly.
F.3.7
The laboratory shall identify critical reagents and evaluate their acceptability prior to
use in sample testing. These critical reagents include but are not limited to:
(a) Restriction enzymes/Proteinase K
(b) In-house/Commercial reagents and buffers
May 9, 2005 12