To apply for an operating license, the commercial medical waste treatment, storage, and/or disposal (TSD) facility or mobile treatment system shall submit each of the following to the Department of Health’s Medical Waste Program:

1. (1) An annual fee of two hundred fifty dollars ($250) which includes the operating license annual fee for a mobile treatment system fleet operated by an applicant;

2. (2)

   1. (A) A completed and signed application for a commercial medical waste treatment, storage, and/or disposal (TSD) or mobile treatment system operating license which includes the legal owner or owners, proposed physical facility address, mailing address, and organization status of the applicant on forms provided by the department.
   2. (B) For mobile treatment systems, the facility's address where on-site treatment will occur must be included;
3. (3) The legal description of the property and a plot plan and area map, unless previously submitted to the department or operation as a mobile on-site treatment system;
4. (4) Written process description and process flow diagram sufficient in detail to show the processes used in managing medical waste;
5. (5) Proposed operating rates, including the type and amount of medical waste to be treated, stored, or disposed and proposed maximum operating hours per day, hours per month, days per week, and weeks per year;
6. (6) For a commercial medical waste incinerator treatment, storage, and/or disposal (TSD) facility, a copy of an incineration permit issued by the Division of Environmental Quality;

7. (7) Certification forms provided by the department of a duly authorized representative of the company stating the company understands and is/will comply with all applicable portions of the following:

   1. (A) This part, Rules Pertaining to the Management of Regulated Medical Waste from Healthcare Related Facilities; and
   2. (B) The United States Occupational Safety and Health Administration Bloodborne Pathogen Standard, 29 C.F.R. § 1910.1030, as applicable; and

8. (8)

   1. (A) A written operating plan/procedure for the handling, treatment, storage, and disposal of medical waste.

   2. (B) The following plan/procedure shall include the following:

      1. (i) A method of receiving and handling medical waste separately from other waste until treatment/disposal which prevents unauthorized persons access to or contact with the waste;

      2. (ii) A method of unloading and processing the medical waste which:

         1. (a) (a) Limits the number of persons handling the waste; and
         2. (b) (b) Minimizes the possibility of exposure of employees and the public to medical waste;

      3. (iii)

         1. (a) (a) A method of decontaminating emptied reusable medical waste containers, transport vehicles, or facility equipment that are or are believed to be contaminated with medical waste.
         2. (b) (b) Note. All transport cargo compartments, facility equipment, or other items shall be disinfected when contaminated or when it is believed to be contaminated.
      4. (c) (c) All disinfectants shall meet the requirements of 20 CAR § 53-307(d)(2)(B);

      5. (iv)

         1. (a) (a) The provision and required use of personal protective equipment for persons manually unloading or handling containers of medical waste.
         2. (b) (b) Contaminated protective equipment shall be disposed of as medical waste or cleaned and decontaminated;
      6. (v) A description of the means of decontaminating any person having had bodily contact with medical waste while transporting, managing, treating, or disposing of the waste;

      7. (vi)

         1. (a) (a) Procedures to be followed in the event an individual or individuals have bodily contact with medical waste.
         2. (b) (b) These procedures shall include decontamination procedures and procedures for medical care; and
      8. (vii) Procedures to be followed in response to equipment failure, utility failure, fire, explosion, spills, leaks, and/or releases which could threaten public health or the environment.