On Mon, Sep 30, 2013 at 7:27 AM, Westlund, Cheryl <[log in to unmask]
> wrote:

>
> I am getting ready to write a quick reference guide for managing records in
> a home office (and vehicles) for our sales and service employees who are
> located throughout the U.S.  I am looking for ideas on what to include in
> this guide as special considerations when managing records in a home
> office.  I would also love to see some search key word options as I have
> tried several this morning with not much luck.
>
>
> Thanks!
> Cheryl Westlund, CRM
> Roche Diagnostics Records and Information Management Office / Phone:
>
>
Instead of a reference guide, I'd suggest a POLICY and TRAINING, at least
in the form of a questionnaire for all impacted employees to take to ensure
the policies THEY follow are consistent with the Corporate policy.  Part of
the policy might be to include periodic 'assessments' be made by someone
from Corporate to ensure they are in compliance.

You may need to give consideration to any requirements in 21CFR relative to
records, given you work for a Pharmaceutical.

I'd suggest a survey be performed of the types of records any of these
individuals may possess, then make a determination what levels of
protection they should be afforded.  If any of these are "one off" records,
you may want to establish a policy that they have access to scanners or
copiers, and that they retain the copies rather than the originals.  You
can then look into establishing contracts with overnight shippers for
originals to be transferred to a Corporate location, or set up secure
transmission for electronic records that are similar.

Consideration should be given to evaluating the requirements in HIPAA for
storage/protection of records, and you may want to consider placing your
staff under a "Business Associates Agreement", unless you are willing to
accept full responsibility for any exposure of information.

Without a doubt, ALL RECORDS, physical formats OR electronic should be
stored independent of the individual's personal records.  It's NEVER a good
idea to commingle personal and business records, even when running a
home-based business.

Any records containing PII, PHI, PFI will require a higher level of
protection- encryption if stored electronically; physical safeguards to
avoid exposure if stored in physical form.  And any backups will also need
to be properly protected.

As for "vital", your organization must have a definition you use to
determine what is considered vital, so it should be easy to determine if
any of the records these individuals have meet that definition.

Good luck !

Larry
[log in to unmask]
-- 
*Lawrence J. Medina
Danville, CA
RIM Professional since 1972*

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