The freestanding emergency center shall have a clinical
laboratory to perform services commensurate with the FEC's needs for its
patients, which is certified under the Clinical Laboratory Improvement
Amendments of 1988 (CLIA 88) and 42 CFR 493. Anatomical pathology services
shall be available either in the FEC or by arrangement with other
facilities.
a) Adequacy of Laboratory
Services. Clinical laboratory services adequate for the individual FEC shall be
maintained in the FEC, as determined by the following:
1) The extent and complexity of services are
commensurate with the size, scope and nature of the FEC and the demands of the
medical staff upon the laboratory.
2) Basic laboratory services, necessary for
routine examinations as defined in subsection (b) of this Section, are provided
in the FEC.
b) Clinical
Laboratory Examinations. Basic clinical laboratory examinations, including
chemistry, microbiology, hematology, serology and clinical microscopy, shall be
carried out as required by the medical staff.
1) Other laboratory examinations may be
provided under arrangements by the FEC with another laboratory that is
certified under CLIA 88.
2) In the
case of work performed by an outside laboratory, the original report from this
laboratory shall be contained in the medical record.
c) Availability of Facilities and Services
1) Facilities and services shall be available
at all times.
2) Where services are
provided by an outside laboratory, the conditions, procedures, and availability
of examinations performed are to be in writing and available in the
FEC.
d) Laboratory
Report
Signed or otherwise authenticated reports shall be filed with
the patient's medical record and duplicate copies maintained in the
laboratory.
1) The laboratory director
shall be responsible for the laboratory reports.
2) All tests and procedures shall be ordered
by a member of the medical staff or by others in accordance with approved
policies.
e) Pathologist
Services. Services of a pathologist shall be provided as indicated by the needs
of the FEC.
1) Services are to be under the
supervision of a pathologist certified by the American Board of Pathology or
who possesses training and experience acceptable to the Department and
equivalent to such certification, and who is licensed to practice medicine in
all of its branches in Illinois, on a full-time, regular part-time or regular
consultive basis. If the latter pertains, the FEC shall provide for, at a
minimum, semimonthly consultive visits by a pathologist.
2) The pathologist shall participate in
staff, departmental and clinicopathologic conferences.
