Position Statement
Subject:
Clinical
Laboratory Testing
Presented By:
Committee on Rheumatologic Care
For Distribution To:
Members of the American College of Rheumatology
Members of Congress
Centers for Medicare & Medicaid Services
Medical Societies
Arthritis Foundation and other Groups that advocate on behalf of people
with rheumatic diseases
Background:
Over the past several years, focus on the issue of physician office
laboratories has intensified. Public interest was heightened by media
reports that laboratory testing was inaccurate and harmful to the well-being
of patients. Clinical laboratory services have also been the subject
of increased attention by federal and state legislators.
Physician office laboratory testing offers numerous benefits to patients
and physicians. The prompt receipt of test results and the capability
to evaluate specimens directly improves the efficiency of the physician
in many common ambulatory patient encounters. Treatment plans can be
established or modified in a timely manner in this situation.
Office testing is an important component of a comprehensive
patient care program
• It is convenient for patients to have all tests performed
at one facility.
• Individuals with acute symptoms, or the elderly or disabled,
can be evaluated more effectively in the office.
• Patients with rheumatic diseases may have severe mobility
limitations. This could present considerable hardship if they were required
to travel to an outside laboratory.
• Office testing can be cost-effective. It may reduce the
number of return visits as well as saving travel time and costs for patients
and their families, including leave time for employed patients.
• The expertise of the rheumatologist may insure better laboratory
support in areas such as synovial fluid analysis and specialized tests
such as rheumatoid factor.
POSITION:
The American College of Rheumatology believes that all
laboratories, including physician office laboratories, should participate
in appropriate quality assurance activities. The following components
must be included:
-
Selection of test methods appropriate to the needs of those served by the laboratory and within the technical capabilities
of the facility;
-
A quality control program which monitors precision of laboratory performance;
-
A proficiency testing program;
-
An instrument maintenance program;
-
A continuing education program for the laboratory staff, as well as review and maintenance of a laboratory procedures
manual;
-
Reasonable documentation of laboratory functions;
-
Efficient record-keeping, reflecting both historical and current information to allow for ready
comparison of test results which can be applied to the therapeutic
situation at hand.
Physician office laboratories should be required to meet the following standards:
-
Physician office laboratories shall have sufficient space, equipment, facilities, and supplies for the performance of their required volume of work with accuracy, precision, efficiency, and safety and to
provide prompt and reliable reporting of results.
-
Physicians who direct the laboratory shall be responsible for ensuring that there is
sufficient personnel with adequate training to conduct the work of the laboratory.
A certified (ASCP, state or equivalent) medical technician should be permitted to serve in
the capacity of general supervisor when the laboratory physician director is not on the laboratory premises.
-
Federal regulation of physician office laboratories should
explicitly recognize private sector regulation programs as appropriate
whenever possible. New regulation should build upon existing programs,
such as that of the Commission of Laboratory Assessment (COLA). There
is precedent for this in other sectors of the health care system, e.g.,
the Joint Commission for Accreditation of Healthcare Organizations (JCAHO).
Those laboratories which meet the standards of an approved private sector
accreditation body, should be automatically approved
for federal certification provided that the accreditation body has standards
that are “equal to or more stringent” than those of the Department of
Health and Human Services (HHS). This should preclude the need for laboratories
to apply separately for federal certification or to provide additional,
duplicative documentation and fees to HHS once the laboratories have
satisfied the requirements of a private accreditation body.
-
Physician office laboratories provide an important and
cost-effective service to patients that must be recognized and preserved
under any federal policies to promote quality assurance.
-
Rheumatologists, in directing their office laboratories,
are the most qualified managers for determining the utilization of specific
tests and for analyzing their results and applying these results to therapeutic
situations.
-
When proficiency-testing results are requested by interested
parties, the information necessary for their interpretation must be included.
-
Because patients with arthritis and other rheumatic diseases
have difficulty traveling, it is appropriate to offer laboratory services
conveniently available to their source of care. In-office laboratory
testing minimizes the risk of sample loss and provides more timely results
for patient care.
-
Laboratory services should be considered separate from
evaluation and management services. The ACR opposes any cost containment
efforts that recommend the bundling of laboratory services into physician
office visit payments. Payment for new diagnostic lab test must take
into account appropriate reimbursement for in-office testing. Any reimbursement
proposal, based on averaging of laboratory test payments, is inherently
inequitable because it is practically impossible to measure individual
physician case-mix and severity of illness categories and adjust for
them accordingly.
Approved by Committee on Rheumatologic Care: 06/25/05; 10/07/02; 07/31/99
Approved by Board of Directors: 08/06/05; 10/25/02; 08/21/99
