Maintaining Compliance
ICAVL POLICIES, STANDARDS AND
THE LABORATORY'S RESPONSIBILITY
from
the July 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 ICAVL 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 ICAVL and assist in the assurance of
accurate representation of the laboratory's commitment to quality
through the process of accreditation.
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maintaining
compliance
The
laboratory must notify the ICAVL, 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 ICAVL.
The
laboratory must notify the ICAVL, in writing, within 30
days, of any change to the laboratory name, address, ownership,
or significant change in operation.
The
laboratory must notify the ICAVL 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 ICAVL 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 ICAVL.
A site can 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 ICAVL, updating the list of mobile
sites serviced by the laboratory will help in avoiding
conflicts with insurance payers who routinely seek information
from the ICAVL 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 ICAVL.
Accreditation
is valid only for those specific testing areas granted
by the ICAVL. 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 ICAVL Standards must be maintained throughout
the accreditation cycle. The ICAVL can request additional
documentation to assure continued compliance at any time.
Ways to help assist in maintenance of the ICAVL 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 ICAVL 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 ICAVL to receive concerns and complaints
regarding a given accredited laboratory's lack of adherence
to the requirements of the ICAVL 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.
Upholding the standards of accreditation and complying with
the ICAVL policies each contribute to maintaining the integrity
of the accreditation process and illustrating the true commitment
to quality care that ICAVL accredited laboratories demonstrate
through continued diligence and dedication.
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