Maintaining Compliance
ICAEL
POLICIES, STANDARDS AND THE LABORATORY'S RESPONSIBILITY
from
the September 2006 issue
Due
to the pressures associated with working in the demanding environment
of healthcare, often some of the additional responsibilities
of having an accredited laboratory can be overlooked. When granted
accreditation, all laboratories are required to adhere to the
policies and standards set forth by the ICAEL throughout their
accreditation period.
Below
are a few of the key elements to keep in mind in order to avoid
placing a laboratory's accreditation at risk, maintain optimal
communication with the ICAEL and assist in the assurance of
accurate representation of the laboratory's commitment to quality
through the process of accreditation.
- The
laboratory must notify the ICAEL, in writing,
within 30 days, of any change in the Medical or
Technical Director positions. If vacated, these
positions must be filled with qualified individuals
within 60 days of the change and the appropriate
documentation submitted to the ICAEL.
- The
laboratory must notify the ICAEL, in writing,
within 30 days, of any change to the laboratory
name, address, ownership, or significant change
in operation.
- The
laboratory must notify the ICAEL of changes in
the email address of the Medical and Technical
Directors or the general laboratory email.
- If
the accreditation is expired, lapses or is suspended
for any reason, use of the ICAEL logo is strictly
prohibited.
- If
additional sites are added to the laboratory,
they are not considered accredited until a multiple
site application is submitted and notification
is received from the ICAEL. An additional site
may be added at any time during the accreditation
cycle, but will expire at the same time the main
site accreditation expires.
- Although
not required by the ICAEL, updating the list of
mobile sites serviced by the laboratory will help
in avoiding conflicts with insurance payers who
routinely seek information from the ICAEL regarding
the sites serviced by accredited mobile services.
Mobile services are not considered accredited
until a mobile service application has been submitted
and notification is received by the ICAEL.
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- Accreditation
is valid only for those specific testing areas
granted by the ICAEL. Use of the accredited laboratory
logo or other forms of implied accreditation status
in conjunction with other testing that may be
performed in the laboratory is strictly prohibited.
- Adherence
to the ICAEL Standards must be maintained
throughout the accreditation cycle. The ICAEL
can request additional documentation to assure
continued compliance at any time. Ways to help
assist in maintenance of the ICAEL Standards
are:
- documentation
of formal laboratory / QA meeting minutes
- regular
review of examinations performed by all technical
staff members to assure technical quality
and complete documentation in conjunction
with the ICAEL Standards and the laboratory
protocols
- routine
review of final reports from each medical
staff member to confirm reports' content and
adherence to the laboratory's diagnostic criteria
- the
Standards are reviewed and potentially
revised every two years; when notified of
the Standards revisions, update protocols
and/or policies to reflect the most current
requirements and implement immediately
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It
is not uncommon for the ICAEL to receive concerns and complaints
regarding a given laboratory's lack of adherence to the requirements
of the ICAEL Standards and policies. These written grievances
come from patients, professional contacts, and employees of
accredited laboratories. Any complaint is taken seriously and
further investigation is initiated whenever warranted.
By
upholding the standards of accreditation and complying with
the ICAEL policies, laboratories contribute toward maintaining
the integrity of the accreditation process, as well as illustrate
to all the true commitment of quality care that defines the
ICAEL accredited laboratory.
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