Rule 4729:11-3-01 | Minimum standards for licensees.
(A) This rule sets forth the minimum acceptable standards for licensure as a HME services provider under Chapter 4752. of the Revised Code.
(B) A licensee shall maintain knowledge of the duties and responsibilities of a HME services provider and shall practice in accordance with the following:
(1) Chapter 4752. of the Revised Code;
(2) Division 4729:11 of the Administrative Code;
(3) Any other applicable federal and state laws, rules and regulations; and
(4) Position statements, standards of care or guidelines for providing HME services from nationally recognized organizations, including medicare durable medical equipment, prosthetics, orthotics, and supplies (DMEPOS) supplier standards, joint commission, or other accrediting bodies recognized by the board pursuant to rule 4729:11-2-04 of the Administrative Code.
(C) A licensee and the licensee's staff shall demonstrate competence and accountability in all areas of HME services in which they are engaged, including, but not limited to, the following:
(1) HME storage, leasing, sales, delivery, billing services, maintenance, cleaning, infection control, and repair;
(2) Appropriate recognition, referral, or consultation and intervention when a complication arises in conjunction with the function of HME or when a change in patient or client compliance occurs; and
(3) Referral to another HME services provider if the client's needs are beyond the scope of the license holder.
(D) A licensee is responsible for maintaining a facility that meets all the following requirements:
(1) The facility must have appropriate physical space to safely store, maintain and service on site equipment;
(2) The facility must have separation of business office, patient records, equipment cleaning, maintenance, and storage functions, as applicable;
(3) The facility must be able to demonstrate appropriate equipment flows through various stages to ensure that the equipment is properly disinfected, repaired, stored, and maintained;
(4) The facility must maintain inventory on site or by arrangement with a supplier to meet the needs of the licensee's current client base; and
(5) The facility must meet all federal, state and local laws, rules, and regulations, including those pertaining to the storage, maintenance, and sale of upholstery or bedding, if applicable.
(E) In maintaining equipment, a licensee shall:
(1) Maintain and document equipment in accordance with the manufacturer's guidelines;
(2) Clean, disinfect, repair, store, segregate and identify all equipment in a manner that ensures the equipment is safe for use by the public;
(3) Ensure that all equipment is used within the manufacturer's recommended guidelines and expirations dates, if applicable.
(F) A licensed HME services provider shall:
(1) Maintain appropriate staffing to handle the scope of equipment sold, rented and maintained and to appropriately meet the demands of the business.
(2) Ensure that all staff members are trained and supervised by qualified persons.
(3) Maintain personnel records for each employee, which shall include all of the following:
(a) Job description for the position held by the employee.
(b) Application qualifications.
(c) For any employee that provides HME services, supervises an employee who provides HME services, or has access to records maintained in accordance with rule 4729:11-3-02 of the Administrative Code who is working within the state of Ohio, a criminal background check shall be performed only upon initial hire by the Ohio bureau of criminal identification and investigation (BCI&I) and shall consist of both a BCI&I and FBI criminal records check.
(d) Orientation and training records.
(e) Verification of competence.
(f) Performance plan to be completed annually by the licensee.
(G) A licensed HME services provider shall possess product and professional liability insurance coverage in the amount of one million dollars per occurrence, three million dollars aggregate. The certificate of insurance must show that the product and professional liability insurance coverage is contained in the total aggregate amount.