.04 General Licensure Provisions.

A. A person, partnership, corporation, or association, or any State or local government or agency thereof, may not conduct, operate, or maintain a home health agency in the State without being licensed by the Department. A license is valid for 1 year from the date of issuance, unless revoked by the Secretary.

B. Application for License. An agency desiring to conduct, operate, or maintain a home health agency in the State shall file an application with the Secretary, on a written or electronic form provided by the Secretary.

C. Renewal of License. An agency shall file an application on the written or electronic form provided by the Secretary for renewal of the license at least 60 days before expiration of the issued license and submit it on forms provided by the Secretary.

D. The home health agency shall:

(1) Demonstrate compliance with all applicable federal, State, and local laws and regulations, including the requirement of Health-General Article, Title 19, Subtitle 1, Annotated Code of Maryland.

(2) Provide liability insurance to cover all employees. The agency shall also ensure that its contractual persons possess appropriate liability protection.

(3) Maintain records as determined by the Department and make the records available to the Department upon request.

(4) Accept patients for skilled care only on the signed order of a physician, obtained within 28 days after acceptance.

(5) Contact a physician to obtain a signed order as soon as possible, but not later than 10 days after acceptance of a patient for skilled care, and record all efforts to contact the physician.

(6) Adopt procedures for the administration of drugs and biologicals which shall include:

(a) The administration of treatment modalities, including any intravenous procedures, chemotherapy, parenteral feedings, and injections;

(b) The assurance of 24-hour-a-day availability of care for the hours during the administration of intravenous medications and nutritional support;

(c) The administration of drugs and treatments only by the following licensed agency staff:

(i) Physician,

(ii) Registered nurse, or

(iii) Licensed practical nurse if the drugs or treatments are administered under the supervision of a registered nurse in accordance with the physician's plan of treatment, and in accordance with a plan of care developed by a registered nurse;

(d) Minimum training in keeping with applicable law for staff who administer drugs and treatments;

(e) Drugs and treatments to be administered only as ordered by the physician;

(f) Documentation in the patient's medical record of medications administered and any medication errors, adverse drug reactions, and corrective actions;

(g) If the agency provides to any patient controlled drugs as described in Criminal Law Article, Title 5, Subtitle 4, Annotated Code of Maryland, written policies and procedures governing the disposal of controlled drugs in accordance with applicable federal and State laws and regulations.

(7) Have services available at least 8 hours a day, 5 days a week, and available on an emergency basis 24 hours a day, 7 days a week by:

(a) Establishing a procedure by which any patient may contact a representative of the agency at any time by telephone;

(b) Ensuring that the person receiving patient calls is able to contact a registered nurse immediately, but not later than 1/2 hour after receipt of a patient's call; and

(c) Ensuring that the registered nurse:

(i) Assesses the patient's needs; and

(ii) In emergency situations, renders immediate care to the patient, or causes the patient to be treated by an appropriate health care provider.

E. The Department shall:

(1) Issue its operating license only to the home health agency named in the application. The license may not be transferred or reassigned. The license shall be immediately void if the home health agency ceases to operate and shall be returned to the Department.

(2) Issue licenses which expire 1 year from the date of its issuance or, in the case of a provisional license, on the date specified at the time of issuance, unless otherwise revoked or suspended by the Department.

(3) Make inspections and surveys at least annually to determine compliance with the regulations.

(4) Conduct its inspections, surveys, and investigations at all reasonable times and at all geographical locations considered necessary for the proper conduct of its business.

(5) Prepare a written report detailing its determination of compliance with those regulations. A copy of this report shall be forwarded to the applicant within 30 days of the inspection.

F. If a parent agency is located outside the State, the Department shall issue a license if:

(1) At least one branch office is located within the State; or

(2) The parent agency is located in a state bordering Maryland and either the:

(a) Bordering state has a reciprocal agreement for home health licensure, under which the agency may be inspected at the discretion of the Department; or

(b) Agency agrees to be inspected by the Department.

G. Investigation of complaints shall be conducted by the Department as necessary.