(1) Each outpatient center must maintain a policy and procedure manual. The policy and procedure manual must be reviewed by the medical director or administrator and updated as necessary, but at least annually. The manual must contain policies and procedures for:
(b) patient education;
(c) preoperative assessment;
(d) postoperative assessment;
(e) observation and recovery;
(f) discharge planning;
(g) emergency procedures of the outpatient center to include information on the transfer agreement with the receiving hospital;
(h) anesthesia policies as described in ARM 37.106.514;
(i) business practices; and
(j) patient and staff security.
(2) The policy and procedure manual must include a current organizational chart delineating the lines of authority, responsibility, and accountability for the administration and provision of all outpatient center patient services.
(3) Each outpatient center must have policies and procedures that address the criteria for clinical staff privileges and the process the governing body uses when reviewing physician credentials and determining whether to grant privileges.
(4) The outpatient center must implement a policy and a process which addresses the Food and Drug Administration (FDA) or manufacturer recall of drugs, vaccines, blood and blood products, medical devices, equipment, and supplies. The policy must address:
(a) the sources of information;
(b) methods for notifying staff;
(c) methods to determine if the recalled product is present at the facility;
(d) documentation of response to the recalled product;
(e) disposition or return of the recalled product; and
(f) patient notification as appropriate.