Ala. Admin. Code r. 420-5-8-.02

Current through Register Vol. 42, No. 7, April 30, 2024
Section 420-5-8-.02 - The License
(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

Ala. Admin. Code r. 420-5-8-.02

Filed September 1, 1982. Amended: Filed May 20, 1996; effective June 24, 1996. Amended: Filed December 20, 2002; effective January 24, 2003.

Statutory Authority:Code of Ala. 1975, §§ 22-21-20, etseq.