10.12.01.04

.04 Inspections by the Department.

A. Open for Inspection. A licensed facility or an entity proposing to operate such a facility shall be open during normal business hours, or any other times that the facility is serving patients, for inspection by the Department and by any other agency designated by the Department to:

(1) Verify compliance with this chapter; and

(2) Investigate a complaint concerning patient care and safety as described in §B of this chapter.

B. Complaints.

(1) In response to a complaint, the Department may:

(a) Require the facility to perform and submit its own investigation; or

(b) In its discretion, conduct an on-site investigation of a complaint.

(2) In order to determine whether an on-site investigation as described in §B(1)(b) of this regulation is appropriate, the factors the Department shall consider include, but are not limited to:

(a) Whether the complainant has first-hand knowledge of the alleged incident;

(b) The facility's regulatory history, including the number of verified prior complaints;

(c) Whether the Department has recently inspected the facility, and whether the incident would have been observed during the prior review; and

(d) The nature of the complaint, including degree of potential serious harm to patients.

(3) If the complaint concerns the performance of a physician, health professional, or standards of practice, the Department shall refer the complaint to the board that licenses, certifies, or otherwise authorizes the physician or health professional to provide services under Health Occupations Article, Annotated Code of Maryland.

(4) The Department shall:

(a) Comply with the requirements for medical review committees as described in Health Occupations Article, §1-401, Annotated Code of Maryland; and

(b) Keep patient information confidential in accordance with State and federal laws.

C. Noncompliance. If the Department determines that a facility fails to meet any provision of this chapter, the Department shall:

(1) Advise the facility of the exact nature of the violation; and

(2) Require that the facility specify what corrective action it is taking and monitor the facility to ensure that it takes corrective action.

D. Records and Reports. The facility shall make its records and reports available to the Department on site at the facility during an inspection.