CMS SOM App. A, Tag A-0760

The

hospital must demonstrate that:

(1) An individual (or individuals), who is qualified through education, training, or experience

in infectious diseases and/or antibiotic stewardship, is appointed by the governing body as the

leader(s) of the antibiotic stewardship program and that the appointment is based on the

recommendations of medical staff leadership and pharmacy leadership;

Interpretive Guidelines §482.42(b)(1)

Antibiotic stewardship, has long been recognized as one of the special challenges that facilities

must meet in order to address the problems of infectious disease treatment, medication safety

and multidrug-resistant organisms in hospitals.

The hospital must designate an individual or group of individuals as its antibiotic stewardship

program leaders. Ideally, an antibiotic stewardship program is jointly led by a physician and

pharmacist. The individual(s) must be appointed by the hospital’s governing body based on the

recommendations of the medical staff leadership and pharmacy leadership. The hospital must

ensure high-level hospital clinical leadership, specifically leadership from the medical staff and

the pharmacy service, are involved in the process of selecting the antibiotic stewardship leaders.

This high-level participation promotes a hospital-wide culture of safety and quality in which

input across the hospital is solicited and acted upon.

In designating antibiotic stewardship leaders, hospitals must ensure that the individuals so

designated are qualified through education, training, experience, or certification in antibiotic

stewardship. Training and/or certification may be obtained through organizations such as the

specialty boards in adult or pediatric infectious diseases offered for physicians by the American

Board of Internal Medicine (for internists), the American Board of Pediatrics (for pediatricians),

and the Society for Infectious Disease Pharmacists (for pharmacists)

Antibiotic stewardship staff should maintain their qualifications through ongoing education and

training, which can be demonstrated by participation in antibiotic stewardship courses, or in

local and national meetings organized by recognized professional societies. Organizations that

provide ongoing training and education include the Society for Healthcare Epidemiology of

America (SHEA), and the Infectious Diseases Society of America (IDSA) and the Society for

Infectious Disease Pharmacists (SIDP).

CMS does not specify either the number of antibiotic stewardship staff to be designated or the

number of antibiotic stewardship hours that must be devoted to the antibiotic stewardship

programs. However, resources must be adequate to accomplish the tasks required for the

antibiotic stewardship program. In hospitals with more than one antibiotic stewardship staff

member, the staff members should work as an integrated team to ensure the functions of an

antibiotic stewardship program are covered. A prudent hospital would consider patient census,

characteristics of the patient population, and complexity of the healthcare services it offers in

determining the size and scope of the resources it commits to antibiotic stewardship. SHEA has

studies and recommendations on resource allocation that hospitals may find useful.

The antibiotic stewardship staff must develop and implement policies governing the optimal use

of antibiotics. Antibiotic stewardship policies should address the roles and responsibilities for

antibiotic stewardship and use within the hospital; how the various hospital committees and

departments interface with the antibiotic stewardship program; and how to optimize antibiotic

use.

Survey Procedures §482.42(b)(1)

• Determine whether the antibiotic stewardship leadership and staff was/were appointed by

the governing body based on recommendations of the medical staff leadership and

pharmacy leadership and has the responsibility for the antibiotic stewardship program.

• Review the personnel file of the antibiotic stewardship staff to determine whether

he/she/they is/are qualified through ongoing education, training, experience, or

certification to oversee the antibiotic stewardship program.

• Determine whether the antibiotic stewardship staff have developed and implemented

hospital antibiotic stewardship policies.

• Review the criteria the hospital used to determine the resources necessary to operate

effectively and ensure the resource allocation matches the determined needs.