216-40-10 R.I. Code R. § 24.8

Current through June 12, 2024

Section 216-RICR-40-10-24.8 - ADMINISTRATIVE REQUIREMENTS

24.8.1GENERAL ADMINISTRATIVE REQUIREMENTS

A. The registrant shall be responsible for directing the operation of the tanning facility which has been registered with the Department. That registrant shall assure that the provisions of this Part are met in the operation of a tanning facility.

B. The registrant shall ensure that the tanning facility complies with all applicable federal, state and local codes, laws and regulations.

C. Each registrant shall establish and maintain a tanning facility specific electronic mail address (i.e., e-mail address) to be provided to the Department for the purposes of contacting the registrant with both routine communications and emergency notices. The registrant shall be responsible for providing notice to the Department at any time that the tanning facility's specific electronic mail address is changed or updated.

24.8.2TRAINING OF PERSONNEL

A. The registrant shall certify that all tanning facility staff are adequately trained and have been issued a training manual established for that facility. This training and manual shall include, but not be limited to, coverage of the following provisions:

1. The requirements of this Part;

2. Procedures for correct operation of the tanning facility and sunlamp products;

3. Guidelines for the recognition of injury or overexposure to ultraviolet radiation;

4. The sunlamp product manufacturer's procedures for operation and maintenance of the sunlamp products;

5. Guidelines for the determination of skin type of customers and appropriate determination of duration of exposure to sunlamp products;

6. Procedures for the use of patron consent forms;

7. Emergency procedures to be followed in case of injury;

8. Potential photosensitizing foods, cosmetics, and medications;

9. Requirements for the proper use of protective eyewear;

10. Proper sanitizing procedures for eyewear, facility, and devices; and

11. Instructions for use of sunlamp product to avoid or to minimize potential injury to the patron, as required by 21 C.F.R. § 1040.20(e).

B. The registrant may use vendor-provided information in establishing the facility's training manual, provided that this material contains all of the above information.

C. Staff training shall be documented by the registrant. Such documentation shall include the dates and times of the training, as well as the subjects covered in each training session

D. Tanning equipment shall only be operated when a trained tanning operator is present at the tanning facility.

24.8.3RECORDS AND REPORTS

A. The registrant shall be responsible for maintaining all records as described in this Part.

B. All required records shall be maintained at the tanning facility for a minimum of three (3) years and shall be available for review by the Department.

C. All required records may also be completed, transmitted, and stored in electronic media with the capability for producing legible, accurate, and complete copies of the records. If records are stored electronically, they shall be maintained in a manner that will allow retrieval of records for any specified time period.

D. Patron Records

1. The registrant shall maintain a record of each patron's total number of tanning visits, dates and durations of tanning exposures.

2. The registrant shall maintain a record of each patron's signature and acknowledgment that he/she understands the potential risks involved with exposure and overexposure to ultraviolet radiation and he/she has reviewed a photosensitizing drug list.

E. Within five (5) working days after occurrence or knowledge thereof, the registrant shall submit to the Department a written or electronic report of each actual or alleged accident or injury that results from the use of registered sunlamp products for which medical attention was sought or obtained. The report shall include:

1. The name of the affected individual(s);

2. The name, location and phone number of the tanning facility involved;

3. The nature of the actual or alleged injury(ies); and

4. Any other information relevant to the actual or alleged injury(ies) to include the date and duration of exposure and any documentation of medical attention sought or obtained.

F. The registrant shall maintain a record of staff training as required in §24.8.1 of this Part.

G. The registrant shall maintain records showing the results of timer tests required by §24.7.2(K)(3) of this Part.

H. The registrant shall maintain the following information for each sunlamp product:

1. Manufacturer's equipment manual and any other service-related material or instruction;

2. The exposure schedule provided by the manufacturer; and

3. Records of surveys, inspections, maintenance and modifications performed on the sunlamp product, including the names of persons performing such services, the date of service and the hour meter reading of the product serviced.

I. The registrant shall maintain records showing the receipt, transfer, repair and disposal of all sunlamp products and lamps.

24.8.4ADVERTISING AND PROMOTION

A. No person or establishment registered under the Act and this Part shall use or cause or promote the use of any advertising, promotional literature, testimonial, guarantee, warranty, label, brand, insignia or any other representation, however disseminated or published, which is misleading, deceptive or untruthful.

B. No person or facility shall advertise or promote tanning packages labeled as "unlimited" unless information regarding maximum exposure schedules is included in such advertisements.

1. Promotion of annual tanning packages shall include a written statement listing the total number of sessions allowed per person per year, as listed in §24.6.4(F)(2) of this Part.

216 R.I. Code R. § 216-RICR-40-10-24.8