Fla. Admin. Code Ann. R. 64B27-1.001 - Dental Laboratory Inspections, and Practice and Procedure for Healthy and Safe Dental Laboratory Operation

(1) Each dental laboratory registered by the Department of Health to operate in the State of Florida shall be subject to periodic inspections by Department personnel at least once each biennial registration period. Such inspections shall be conducted during regular business hours and may occur with or without notice.
(2) The following practice and procedure shall be implemented by each registered dental laboratory in the State of Florida and be subject to inspection pursuant to subsection (1) of this section. Each registered dental laboratory shall:
(a) Be clean and orderly and in good repair, with regard to normal fabrication procedures at time of inspection;
(b) All waste materials properly disposed of at the end of each day according to local restrictions;
(c) Maintain on the laboratory premises a copy of the laboratory registration so it is readily available for inspection by Department personnel;
(d) Maintain on the laboratory premises for four years the original or electronic copy of a prescription from a licensed dentist for each separate appliance or artificial oral restorative oral device authorizing construction or repair of the specified artificial oral appliance; and,
(e) Maintain on the laboratory premises a written policy and procedure document on sanitation. Said policy shall include, but not necessarily be limited to:
1. Intake and disinfection procedure for each appliance, impression, bite, or other material posing a possible contamination risk received by the laboratory; and,
2. Separate procedure for handling dental appliances, and impressions previously identified by the dentist, known to have come from carriers of the HBV and/or HIV virus.
(3) Each registered dental laboratory shall have a designated receiving area. The following procedure shall be followed in the receiving area:
(a) Work surfaces and counter tops shall be constructed of non-porous materials which shall be disinfected daily with a chlorine compound, a combination synthetic phenolic, or an iodophor solution that has been diluted according to the manufacturer's directions.
(b) Employees working in the receiving area shall wear disposable gloves, and as an option may wear a facial mask or protective eyewear.
(4) The following dental equipment and supplies shall not be permitted in a registered dental laboratory in this state:
(a) Dental chairs.
(b) X-ray machines.
(c) Anesthetics, sedatives, or medicinal drugs, other than personal prescriptions.

Notes

Fla. Admin. Code Ann. R. 64B27-1.001

Rulemaking Authority 466.038 FS. Law Implemented 466.021, 466.036 FS.

New 5-26-91, Formerly 21-29.001, 61E 4-1.001, 59CC-1.001, Amended 8-6-06, Amended by Florida Register Volume 44, Number 011, January 17, 2018 effective 1/31/2018, Amended by Florida Register Volume 47, Number 106, June 2, 2021 effective 6/13/2021.

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