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It
has been gratifying to work with the ICAVL since its inception.
Its commitment to upholding the rigorous standards of care for
vascular laboratories is a real benefit not only to patients
and payers, but also to all that work and interact with the
health care community. Obtaining ICAVL accreditation demonstrates
significant dedication by your laboratory, too. Your accreditation
application required a substantial investment of time and resources
to complete. You may have needed to hire additional staff or
make procedural changes in your laboratory's past practices
in order to meet the ICAVL's requirements. You certainly needed
to become familiar with the ICAVL's Essentials and Standards.
The process of completing the application -- and the award of
accreditation -- represents an outstanding achievement. I have
been asked to advise you how you can maintain your valuable
ICAVL accreditation, by outlining some of the more common challenges
to ICAVL laboratory accreditation and the measures you can take
proactively to maintain accreditation. In addition, I will describe
the rules which govern the ICAVL's administrative process for
challenging accreditation.
When
assessing whether ICAVL accredited laboratories comply with
ICAVL Standards, it is only natural to focus on the clinical
based standards that reflect the quality of diagnostic medical
services. However, it is important that you realize that just
as your laboratory can have its accreditation suspended or revoked
for lack of compliance with the Standards, your accreditation
could also be jeopardized by some basic administrative and organizational
problems.
Health
care institutions in general -- and particularly those offering
laboratory services -- have been undergoing change, including
organizational and structural changes. The nature of these changes
can have a significant impact on whether your laboratory is
able to maintain ICAVL accreditation. In order for the ICAVL
to be able to demand legal accountability, accreditation is
conferred on the legal owner of the laboratory. Accreditation,
generally speaking, cannot be transferred from one laboratory
to another, without submission and review of an accreditation
application. As stated in the Accreditation Agreement signed
by all applicant laboratories:
"If
granted, accreditation will be valid for a period of three
years from the date of decision (said decision date begin
the date of the ICAVL Board Of Directors meeting in which
the laboratory's accreditation decision was made). If the
laboratory should undergo any change in its name, address,
ownership, Medical Director, Technical Director or any material
significant change in its operation, the Laboratory agrees
that it shall notify the ICAVL of such changes in writing
within thirty (30) days."
Laboratories
are also reminded of this obligation within the letters notifying
them of their accreditation. When ownership of a laboratory
is in a state of change, it is essential that you notify the
ICAVL. It is possible, so long as there is no significant operational
change when new management or new ownership occurs, that your
ICAVL accreditation may be maintained. But you must communicate
such a change and it is your obligation to demonstrate to the
ICAVL that the changes do not compromise your adherence to the
ICAVL's Standards. Similarly, any change in your Medical or
Technical Director positions must be communicated to the ICAVL.
A brief period in which your laboratory is between qualified
staff will not, in general, by itself cause the ICAVL to act
to revoke your accreditation. However, failure to notify the
ICAVL of a change in Medical or Technical Director positions,
along with outlining their replacement, is of grave concern
to the ICAVL.
In
keeping with its mission of ensuring that accredited laboratories
strive to be in compliance at all times with its standards,
the ICAVL has established internal rules for suspending and
revoking a non-compliant laboratory's accreditation. The ICAVL
often receives complaints of non-compliance from other laboratories,
but any person can trigger the ICAVL's review of accreditation
by filing a written complaint with the ICAVL Executive Director.
The complaint is scrutinized based on a number of factors, including
the severity of the allegation and whether a violation of the
ICAVL Standards is alleged. When the ICAVL has determined that
the complaint contains grounds upon which the ICAVL could take
action against the laboratory, a letter outlining the specifics
of the complaint is sent to the Medical Director of the laboratory,
and the laboratory is given an opportunity to respond. If the
laboratory's response does not satisfy the ICAVL Executive Director
that the laboratory is fully compliant, the matter is transmitted
to the ICAVL Compliance Committee for further review and action.
The
ICAVL Compliance Committee, made up of members of the Board
Of Directors, will then review the complaint(s) as well as the
Medical Director's response to determin whether there is a potential
non-compliance problem. If the Committee believes that the laboratory
might be in non-compliance with the Standards, it conducts an
investigation, which may include a site visit to the laboratory.
The laboratory has failed to continue to adhere to the Standards.
The laboratory may then request a hearing by the ICAVL Executive
Committee. If that committee determines that the laboratory
is not in compliance, it can: (1) order the laboratory to take
remedial action to ensure that it is in compliance with the
Standards; (2) impose a sanction upon the laboratory, such as
a letter of reprimand or a suspension of its accreditation;
or (3) revoke the laboratory's accreditation. The laboratory
may appeal the Committee's decision to the ICAVL 's Board Of
Directors. Looking only at the written record, the Board will
determine whether the Committee's conclusion was a clearly erroneous
application of the Standards.
That
being said, if a laboratory fails to respond to the ICAVL's
request for information at any time during their three-year
accreditation period, the ICAVL may determine to revoke its
accreditation immediately. It is therefore extremely important
that you respond to any questions posed by the ICAVL relating
to your compliance with the ICAVL Standards. The ICAVL transmits
all accreditation-dependent correspondence to you by verifiable
means of delivery, so it is certain that you have received the
ICAVL's concerns and are aware of the importance of your response.
The
ICAVL is committed to assisting your laboratory so that you
and the community who depend on the services provided can continue
to be assured that you are offering high quality patient care.
Continuing to ensure that the ICAVL is informed of the changes
to your laboratory's organizational operations will help the
ICAVL make that possible.
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