Current through Register Vol. 42, No. 11, August 30, 2024
(1) Types
of License.
(a) Regular License. A regular
license may be issued by the State Board of Health after the board has
determined that the independent clinical or physiological laboratory is in
substantial compliance with the Rules herein adopted.
(b) Probational license. The State Board of
Health may, in its discretion and in lieu of license revocation, issue a
probational license to a facility when inspection shows that the maintenance
and operation of the facility are such that the independent clinical laboratory
or independent physiological laboratory no longer substantially complies with
the rules adopted herein. However, the Board may issue a probational license
only after determining that the health and safety of patients are adequately
protected despite non-compliance, and that the facility has submitted an
adequate written plan to correct the non-compliance in a timely manner. Maximum
length of time for probational status is one year.
(c) Downgrade or Revocation of License. The
State Board of Health is authorized to downgrade or revoke a license for any of
the following reasons:
1. Violation of any of
the provisions of these Rules.
2.
Permitting, aiding or abetting the commission of any illegal act in such
institution.
3. Conduct or
practices deemed by the State Board of Health to be detrimental to the welfare
of the patients.
(2) Application.
(a) Application. An application for license
or renewal of license shall be made on forms provided by the State Board of
Health and shall contain such information as the Board my require.
(b) Fee. Each application for license shall
be accompanied by a fee as mandated by statute. No fee shall be refunded. Fees
shall be paid by cash, check or money order made payable to the Alabama
Department of Public Health.
(3) Licensing.
(a) Issuance of License. The license shall be
issued by the State Board of Health. It shall set forth the name and physical
location in Alabama of the independent clinical laboratory or independent
physiological laboratory.
(b)
Separate Licenses. A separate license shall be required for each independent
clinical laboratory or independent physiological laboratory when more than one
independent clinical laboratory or independent physiological laboratory is
operated under the same management; however, separate licenses are not required
for separate buildings on the same grounds used by the same independent
clinical laboratory or independent physiological laboratory.
(4) Right of Review. Whenever a
license is denied or revoked, the applicant or licensee will be afforded an
opportunity for a hearing in accordance with the requirements for contested
case proceedings under the Alabama Administrative Procedures Act,
Code of Ala. 1975, §
41-22-17, and Chapter 420-1-3 of
the Alabama Administrative Code.
(a) Research
Projects. Any licensee who is, or contemplates being, engaged in a bona fide
research program which may be in conflict with one or more specific
provision(s) of these Rules, may make application for waiver of the specific
provisions in conflict. Application for waiver shall be made in writing to the
Licensure Advisory Board who shall, upon completion of its investigation, send
its findings, conclusions, and recommendations to the State Board of Health for
final action.
(b) Reissuing of
License. See Section
22-21-25 of Appendix.
(5) Disclosure of Information.
Disclosure of Information received by State Board of Health. Official reports,
such as statements of deficiencies generated by the State Board of Health as a
result of on-site inspections, and plans of correction submitted in response to
those statements of deficiencies, are subject to public disclosure. Information
received through other means and reports, other than statements of
deficiencies, shall be deemed to be confidential and shall not be publicly
disclosed except in response to a valid subpoena or court order or in
proceedings involving the affected facility's license or proceedings involving
the license of another facility operated by the same governing authority.
L. O'Neal Green, Patricia E. Ivie, Rick Harris
Statutory Authority:
Code of Ala.
1975, §§
22-21-20,
et
seq.
