Current through Register Vol. 42, No. 11, August 30, 2024
(1) Each independent physiological laboratory
must have a governing body responsible for the management, control and
operation of the facility. Said governing body is responsible for employing a
qualified person to serve as the laboratory's medical director. Any change in
the appointment of the laboratory's medical director must be promptly reported
to the State Board of Health. Correspondence and inquiries from the State Board
of Health will be directed to the medical director, and the medical director is
responsible for responding to same.
(2) Each independent physiological laboratory
is required to maintain a permanent facility in Alabama where its records are
kept. Any changes in the location of this facility must be submitted to this
office for approval, prior to relocating.
(3) Each independent physiological laboratory
shall employ or have under contract a physician who serves as the medical
director of the laboratory. Said medical director must be a physician licensed
to practice in Alabama. The medical director's duties are as follows:
(a) The medical director must provide written
certification that each of the employees of the laboratory who perform
diagnostic testing or services are appropriately trained and qualified to
perform same. Such written certification, along with a current record showing
each employee's training and qualifications is required to be maintained on
site by the facility. The medical director is required to make a separate
written certification for each employee on an annual basis. If an employee is
not sufficiently trained or qualified to perform the duties assigned to that
employee, then the medical director must not provide written certification for
that employee and the laboratory must not permit the employee to perform such
duties.
(b) Interpretation of the
diagnostic physiological testing results must be performed by the medical
director or other licensed physician. See paragraph (4) below for additional
requirements for specific types of tests.
(c) The medical director is responsible for
periodic verification that the equipment utilized by the laboratory is
functioning properly and producing reliable and accurate results.
(d) The medical director is responsible for
ensuring that the employees performing diagnostic physiological testing and
services receive proper instruction or additional training when needed to
maintain or acquire skills to adequately perform their duties, and is
responsible for notifying the director of the laboratory when there are
problems with personnel or equipment that require correction in order to
maintain reliable and adequate testing results and services.
(4) Before performing carotid
artery, abdominal aorta, ankle brachial vascular, or any other testing
utilizing Doppler technology and ultrasonography on a patient, an independent
physiological laboratory must comply with subsection (a) or (b).
(a) Receive a written order from a physician,
licensed in Alabama, that specifies the name of the patient to be tested and
the reason(s) the physician believes the patient should have the test(s). If
the physician ordering the test(s) is the patient's regular attending
physician, the results shall be returned to that physician for appropriate
follow-up. If the physician ordering the test(s) is an employee or agent of the
independent physiological laboratory, then the physician shall consult with the
patient to explain the results and shall either conduct or arrange for
follow-up tests, consultations, and/or procedures as medically
necessary.
(b) For screening
examinations to be performed in the absence of a written order from a
physician, licensed in Alabama, that specifies the name of the patient to be
screened and the reason(s) the physician believes the patient should have the
screening examination, an independent physiological laboratory shall apply for
and receive permanent written approval from the State Board of Health to
conduct screening examinations. Any independent physiological laboratory
approved under this subsection shall:
1. file
annual reports with the Alabama State Department of Public Health containing
the following information:
(i) the number of
patients screened in Alabama during that year;
(ii) the number of patients screened during
that year with results that indicated the need for follow-up care from a
primary care physician;
(iii) the
number of patients screened during that year with results that indicated the
need for immediate follow-up care from a primary care physician; and
(iv) the number of patients in each above
category who schedule a follow-up visit with a physician.
2. help any patient identify and contact a
primary care physician, if such assistance is requested by the
patient;
3. follow-up by telephone
or letter with any patient whose results indicated the need for follow-up care
from a primary care physician and advise the patient to contact a primary care
physician; and
4. require that any
screening examination performed is reviewed by a physician licensed in the
state of Alabama and board certified in one or more of the following areas:
cardiothoracic surgery, cardiology, vascular surgery, neurology, radiology, or
in internal medicine with special training in vascular medicine.
(5) The laboratory must
develop and follow a written procedure for adequate measures to prevent the
spread of infection. Blood-letting or invasive devices capable of transmitting
infection from one person to another shall be cleaned and sterilized prior to
each use.
(6) Failure to permit
inspection of the physiological laboratory and its records by representatives
of the State Board of Health is a violation of these Rules.
Author: Rick Harris
Statutory Authority:
Code of Ala.
1975, §§
22-21-20,
et
seq.
