Ala. Admin. Code r. 420-5-8-.05
Current through Register Vol. 43, No. 1, October 31, 2024
Section 420-5-8-.05 - Requirements For Independent Physiological Laboratories(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; and4. 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
Ala. Admin. Code r. 420-5-8-.05
New Rule: Filed May 20, 1996; effective June 24, 1996. Amended: Filed December 20, 2002; effective January 24, 2003. Amended: Filed December 16, 2005; effective January 20, 2006.Statutory Authority:Code of Ala. 1975, §§ 22-21-20, etseq.