216 R.I. Code R. 216-RICR-20-10-1.4

Current through December 26, 2024
Section 216-RICR-20-10-1.4 - Procedure for Permits
1.4.1General Requirements
A. It shall be unlawful for any persons, corporation, or other form of entity to own, maintain, conduct or operate a temporary or ad hoc screening program in this state without meeting the requirements of the rules and regulations herein. Furthermore:
1. Any screening program in this state shall be conducted or operated under the overall supervision of either a physician licensed in this state, a clinical laboratory of a hospital licensed in this state, or an independent clinical laboratory licensed in this state and include appropriate personnel in accordance with the provisions of §§1.5.1 through 1.5.2 of this Part.
a. A permit shall be required for those persons seeking to operate an ad hoc screening program under the overall supervision of a physician licensed in this state.
(1) Said permit shall be required to be obtained annually.
b. A permit shall not be required for those clinical laboratories of hospitals licensed in this state or independent clinical laboratories licensed in this state to operate an ad hoc screening program. In these cases, the screening program shall be conducted under the licensee's hospital or independent clinical laboratory license.
2. All persons conducting screening programs shall be required to submit a schedule of each screening site, clearly identifying the specific screening tests to be conducted, and the dates, times and locations of the screening program.
3. The permit fee shall be as set forth in the "Rules and Regulations Pertaining to the Fee Structure for Licensing, Laboratory and Administrative Services Provided by the Department of Health."
a. It is within the Director's discretion to waive the fee. Nothing herein shall require any licensed persons, corporations, or other entity to pay the permit fee, if the screening program is provided free of charge to the public by the licensed persons, corporation, or entity.
4. Any person conducting or operating a screening program shall be required to acquire liability insurance to cover any injury which may be incurred as a result of negligence.
B. A screening program shall represent itself in its advertisements, publications, or other forms of communication, as providing only those categorical screening procedures for which a screening is being conducted and shall not advertise in a manner which tends to mislead or deceive the public.
1.4.2Application for Permit and Fee
A. Persons seeking to operate an ad hoc screening program under the overall supervision of a physician licensed in this state shall submit an application for a permit to conduct or operate said screening program to the Rhode Island Department of Health, Division of Facilities Regulation, on forms provided by the Department and available through the Division. The application shall contain such information as the Department reasonably requires, including but not limited to:
1. The name of the person and/or agency operating or conducting the screening program and the name of the person responsible for the overall medical direction of the program, the name(s) and qualifications of the on-site supervisor and other staff personnel in accordance with §1.5.2(A) of this Part and the location of the site, the date, time and schedule of the screening program;
2. Evidence of ability to comply with the requirements herein including evidence of the qualifications of staff personnel and of holding liability insurance in accordance with §§1.4.1(A)(4), 1.5.1, and 1.5.2 of this Part;
3. A written description pertaining to all aspects of the administration and operation of the screening program including but not limited to:
a. Assurance that the specific screening test(s) to be offered will be conducted in accordance with the guidelines established by the Rhode Island Department of Health, Division of Facilities Regulation;
b. The procedure(s) for monitoring, obtaining informed consents, interpretation and reporting of test results, and follow-up on positive findings, participant education, and referral of identified cases, including an explanation of results, and recommendations for appropriate treatment, prevention and control;
c. Analytical method(s) to be used, type of equipment and/or instrument(s) to be used, and documented evidence to determine accuracy and precision of the instrument(s);
d. A description of the supervisory methods and quality controls, in accordance with §1.5.3 of this Part;
e. Staff training program and qualifications of staff;
f. Copies of educational materials pertaining to specific test(s) and condition(s) to be distributed to the general public at the screening site;
g. Quality control and instrument maintenance records;
h. Provisions to handle emergencies; and
i. Procedures for the disposal of waste consistent with the provisions for the management of medical waste from the Department of Environmental Management's "Rules and Regulations Governing the Generation, Transportation, Storage, Treatment, Management && Disposal of Regulated Medical Waste in Rhode Island."
B. The completed application for a screening program permit shall be accompanied by the documentary requirements of §1.4.2(A) of this Part, including the fee as set forth in the "Rules and Regulations Pertaining to the Fee Structure for Licensing, Laboratory and Administrative Services Provided by the Department of Health."
1. The fee shall be made payable by check or money order to the General Treasurer, state of Rhode Island, and submitted along with the application form at least thirty (30) days prior to the first scheduled screening program. Said materials shall be mailed to the:
a. Division of Facilities Regulation

Rhode Island Department of Health

3 Capitol Hill, Room 306

Providence, RI 02908

1.4.3Issuance of Permit
A. Upon receipt of an application for a permit and accompanying fee, the Department shall issue a permit, if the applicant is found to be in compliance with the statutory and regulatory requirements herein.
B. The permit issued shall be valid only for a period of one (1) year, and only for the specific category(ies) of screening procedures specified on the permit.
C. A permit issued hereunder shall be the property of the state and loaned to the applicant. The permit shall be kept posted in a conspicuous place at the location of the screening program and is not transferable.
1.4.4Denial and/or Revocation of Permit
A. The Department is authorized to deny an application for the issuance of a permit and to revoke any permit issued, if the statutory and regulatory provisions herein are not met.
B. Whenever an action shall be proposed to deny or revoke a permit, the Department shall notify the applicant by certified mail, setting forth reasons for the proposed action, and the applicant shall be given an opportunity for a prompt and fair hearing in accordance with the provisions of §1.6.3 of this Part.
1. However, if the Department finds that public health, safety or welfare of clients requires emergency action and incorporates a finding to that effect in its order, the Department may order summary suspension of the permit pending proceedings for revocation or other action in accordance with R.I. Gen. Laws §§ 42-35-14(c) and 23-1-21.

216 R.I. Code R. 216-RICR-20-10-1.4