by any facility that performs testing
on human specimens for which the
results are employed for assessment
of health and/or diagnosis,
prevention, or treatment of disease.
Accreditation agencies provide
voluntary oversight of laboratories
and may impose additional
requirements that may be more
stringent but can never supersede
CLIA. For compliance with each of
the regulations, MyInspection™
Software provides the following:
• Guidance for required
compliance documentation and
retention of records
• Storage space for unlimited
number of documents
• Ability to expand documentation
as desired with supplemental
document storage
• Structure to accommodate
required documents for required
retention times
• Tools to assist with information
gathering and organization, e.g.
fillable forms, logs, and charts
• Ability to import institution-
specific documents
• Seek expert assistance, as
required
Building Your Compliance System -
Make It Easy!
Together, My Compliance Manual
and MyInspection™ Software make
interpreting CLIA requirements and
some accreditation requirements ea sy.
The manual and the software are
compatible and easy to navigate. Both
tools are organized into sections based
on compliance requirements. For
example, one of the requirements
addresses Personnel Qualifications and
ongoing requirements for each lab
staff member records. My
Compliance Manual offers detailed
“
policy, procedure, and business
practices that guide you through the
regulations. MyInspection™ Software
includes electronic forms that can be
completed or you can choose to utilize
existing documents and import them
into the correct section in the software.
In practice, if you consider My
Compliance Manual to be the source
used for understanding overall
requirements and MyInspection™
Software to document the requirements,
you have almost completely built your
compliance system.
There are always questions when it
comes to the compliance and the
inspection process. As the laboratory
and it’s involved personnel seek
compliance and support the internal
compliance process, the availability of
guidance or assistance from
laboratory experts may be needed.
Both My Compliance Manual and
MyInspection™ Software offer built-
in assistance and helpful hints tools.
These include:
• Hints
• Callouts – compliance items that
are most often cited as
noncompliant during inspections
• Help – guidance for items required
for compliance and information on
how to create a compliance
document (Fill out a form or
import an existing document)
• Development of specific files and
an organized storage system for
individual personnel files
• Development of specific files and
an organized storage system for
individual instruments
Finally, want to speak to a real person
regarding small compliance issues?
Any user of My Compliance Manual
or MyInspection™ Software may
engage the services of My Expert for
compliance assistance or advice.
So, if the laboratory is seeking a
fresh approach to compliance, the
incorporation of My Compliance
Manual, MyInspection™ Software
and My Expert provides a unique,
innovated, paperless, total
compliance approach.
Read this and other articles at
www.PhysiciansOfficeNews.com
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