Hospital infection prevention and antibiotic stewardship programs address infections and antibiotic use across the hospital. For hospitals subject to 42 CFR 482.42, both are conditions of participation. Integral Healthcare Solutions (IHS) drafts program documents for hospital clinical approval.
Last updated: November 2026
What does 42 CFR 482.42 require of a hospital?
The hospital must operate both programs and address identified infection prevention and antibiotic use problems with its hospital-wide quality assessment and performance improvement (QAPI) program. It must follow nationally recognized infection prevention and control guidelines and best practices for improving antibiotic use where applicable and for reducing the development and transmission of healthcare-associated infections (HAIs) and antibiotic-resistant organisms.
Source: 42 CFR 482.42, Condition of participation: Infection prevention and control and antibiotic stewardship programs, current eCFR, page opened November 5, 2026. The section has paragraphs (a)-(e).
| Paragraph | What it asks, in IHS's words | What shows it |
|---|---|---|
| (a)(1) | The governing body appoints people qualified through education, training, experience or certification in infection prevention and control as infection preventionist or infection control professional, based on recommendations of medical staff leadership and nursing leadership. | Appointment record and recommendations |
| (a)(2) | The program, as written in policies and procedures, uses methods that prevent and control transmission of infection inside the hospital and between it and other institutions and settings. | Infection prevention and control policy set |
| (b)(1) | The governing body appoints people qualified through education, training or experience in infectious diseases or antibiotic stewardship to lead the stewardship program, based on recommendations of medical staff leadership and pharmacy leadership. | Stewardship leader appointment record and recommendations |
| (b)(2)(ii) | The stewardship program documents evidence-based antibiotic use in all departments and services. | Stewardship program description and antibiotic use review records |
| (c)(1)(i) | The governing body must ensure systems are in place and operational for tracking all infection surveillance, prevention and control and antibiotic use activities, to demonstrate their implementation, success and sustainability. | Surveillance plan, audit results and the tracking log |
| (c)(2)(iv) | The infection preventionist and stewardship leader are responsible for competency-based education and training on practical application of their respective guidelines, policies and procedures for hospital personnel and staff, including medical staff and, as applicable, contracted personnel working in the hospital. | Training curriculum, rosters and competency checks |
| (d) | A system governing body legally responsible for two or more separately certified hospitals may elect unified programs for all members after determining consistency with applicable State and local laws. It remains accountable for each hospital meeting this section. Each hospital must show that the programs address its circumstances, patient populations, services, needs and local issues regardless of practice or location, and designate local personnel with infection prevention and control and antibiotic stewardship expertise to communicate with the unified programs, implement and maintain their policies, and train staff. | Governing body decision and a unified program charter |
| (e)(1) | Hospitals must electronically report acute respiratory illness information, including influenza, COVID-19 and RSV, using the Secretary's format and frequency. To the extent required by the Secretary, reports include confirmed infections among newly admitted and hospitalized patients, bed census and capacity including critical units and age groups, and limited patient demographics including age. | Reporting procedure with a named owner |
When the Secretary declares a national, State or local public health emergency for an acute infectious illness, (e)(2) also requires electronic reporting in the Secretary's format and frequency: supply and staffing shortages; relevant medical countermeasure and therapeutic inventories, usage or both; and facility structure and operating status, including hospital/ED diversion status. The right-hand column suggests evidence; these are not prescribed document titles. Paragraphs (a)(4) and (b)(4) tie program scope to "the scope and complexity of the hospital services provided," so a build is scaled to your hospital.
Who needs it and what triggers it?
Any hospital subject to the condition needs both programs. These are IHS's suggested reasons to reassess them, as of November 5, 2026:
- A new or newly converted hospital has no appointed infection preventionist or stewardship leader, which paragraphs (a)(1) and (b)(1) call for.
- Policies sit in department binders and do not feed the hospital-wide QAPI program.
- Stewardship runs only inside pharmacy, while paragraph (b)(2)(ii) speaks of documenting antibiotic use "in all departments and services of the hospital."
- A system governing body is moving member hospitals to unified programs under paragraph (d).
- The infection preventionist or stewardship leader has left and the programs must outlast one person.
How IHS helps
IHS assesses gaps against paragraphs (a) through (e), maps evidence, and drafts the charter, surveillance plan, policies, stewardship description, committee and QAPI report formats, and evidence index for your clinicians to approve. A mock review tests the documents and evidence against the section; readiness support helps your team address gaps. Integral Healthcare Solutions (IHS) was founded in 2002 by Thomas G. Goddard, JD, PhD, former Chief Operating Officer and General Counsel of URAC, and works across three practice lines: accreditation consulting, compliance services and program development. This service sits in our Program Development practice line.
Your hospital supplies the governing body appointments and the medical staff, nursing and pharmacy recommendations behind them, your surveillance, audit and antibiotic use data, your current policies and committee minutes, and the clinicians who approve every clinical statement.
The limit: a written program is not an operating program. IHS does not collect infection data, set clinical thresholds or appoint staff, and only your people can run surveillance and audits. IHS does not communicate with CMS, a state survey agency or an accreditor for the hospital.
What to have ready
These are IHS's suggested records for assessment against 42 CFR 482.42, current eCFR, page opened November 5, 2026. The regulation does not prescribe these document titles.
- The governing body's appointment of the infection preventionist or infection control professional, with the person's qualifications and the medical staff and nursing leadership recommendations behind it (42 CFR 482.42, current eCFR, November 5, 2026: paragraph (a)(1)).
- The governing body's appointment of the stewardship program leader, with qualifications and the medical staff and pharmacy leadership recommendations behind it (42 CFR 482.42, current eCFR, November 5, 2026: paragraph (b)(1)).
- Current infection prevention and control policies and procedures (42 CFR 482.42, current eCFR, November 5, 2026: paragraph (a)(2)).
- Your antibiotic use documentation for each department and service (42 CFR 482.42, current eCFR, November 5, 2026: paragraph (b)(2)(ii)).
- Surveillance, audit and tracking records that show activities carried out over time (42 CFR 482.42, current eCFR, November 5, 2026: paragraph (c)(1)(i)).
- QAPI committee minutes and reports that show infection and antibiotic use problems being addressed (42 CFR 482.42, current eCFR, November 5, 2026: lead paragraph).
- Training and competency records for hospital staff, medical staff and, as applicable, contracted personnel working in the hospital (42 CFR 482.42, current eCFR, November 5, 2026: paragraphs (c)(2)(iv) and (c)(3)(iv)).
- For unified programs, the governing body's determination on applicable State and local laws and evidence of hospital-level implementation (42 CFR 482.42, current eCFR, November 5, 2026: paragraph (d)).
- Your procedure and named owner for electronic respiratory illness reporting (42 CFR 482.42, current eCFR, November 5, 2026: paragraph (e)(1)).
If several are missing, book the free introductory call and bring what you have.
How does a program build compare with the alternatives?
Options can be combined. An internal build assigns drafting to hospital staff. IHS offers outside assessment and drafting with hospital clinical approval. When considering surveillance software, assess its functions against your data and workflow needs; the hospital still needs appointed leadership, policies and QAPI collaboration. Counsel can advise on legal interpretation. The scope of each provider's work depends on the engagement. For hospital swing bed conditions, a different text, see our swing bed readiness page.
What does it cost?
42 CFR 482.42 specifies no program fee. IHS scopes each engagement after a free introductory call. Scope depends on the number of hospitals and campuses, services offered and document gaps.
Budget hospital staff time for supplying data, approving clinical content and operating the programs.
What this is not
This is not legal advice. IHS is a consulting firm, not a law firm, and your counsel reads the regulation and State and local law for your hospital. It is not a guarantee of any survey result, and IHS does not decide whether your hospital meets the condition. Your hospital, not IHS, submits anything to CMS, a state agency or an accreditor.
Frequently asked questions
What does 42 CFR 482.42 require of a hospital?
It requires active hospital-wide programs for the surveillance, prevention and control of healthcare-associated infections and other infectious diseases, and for the optimization of antibiotic use through stewardship. Problems the programs identify must be addressed in collaboration with the hospital-wide QAPI program. The section has five paragraphs, (a) through (e).
What is the difference between the infection prevention program and the antibiotic stewardship program?
Paragraph (a) covers infection prevention and control; paragraph (b) covers antibiotic stewardship. The governing body appoints qualified leadership for each program on the required recommendations. These provisions do not expressly require different people to hold the two roles.
Who must the governing body appoint?
It appoints people qualified through education, training, experience or certification in infection prevention and control as infection preventionist or infection control professional, and people qualified through education, training or experience in infectious diseases or antibiotic stewardship to lead stewardship. Each appointment is based on recommendations from medical staff leadership and nursing leadership (infection prevention) or pharmacy leadership (stewardship). Your counsel confirms how this applies to you.
Can a hospital system run one unified program?
Paragraph (d) permits a system governing body legally responsible for two or more separately certified hospitals to elect unified programs for all members after determining consistency with applicable State and local laws. The body remains accountable for each hospital meeting this section. Each hospital must demonstrate consideration of its circumstances, populations, services, needs and local issues regardless of practice or location, and designate local personnel with infection prevention and control and antibiotic stewardship expertise to communicate with the unified programs, implement and maintain their policies, and train staff.
What documents should an infection prevention program contain?
The regulation requires documentation but does not prescribe document titles. IHS maps appointment records, policies, surveillance plans, stewardship descriptions, tracking logs, audit results, training records, QAPI reports and reporting procedures to the relevant paragraphs.
How does the program report to QAPI?
The lead paragraph requires that problems and antibiotic use issues the programs identify be addressed in collaboration with the hospital-wide QAPI program. IHS drafts a committee report template and a hand-off format so findings reach QAPI consistently. The governing body must ensure collaboration with QAPI leadership on all identified HAIs, other infectious diseases and antibiotic use issues.
What does the respiratory illness reporting requirement ask for?
Paragraph (e)(1) requires electronic reporting on acute respiratory illnesses, including influenza, COVID-19 and RSV, using the Secretary's format and frequency. To the extent required by the Secretary, reports include confirmed infections among newly admitted and hospitalized patients, bed census and capacity including critical units and age groups, and limited patient demographics including age. IHS drafts a procedure for hospital staff to check and follow current reporting specifications.
Should we use surveillance software, an internal build or outside drafting support?
The choices are not exclusive. Assess software against your data and workflow needs; the hospital still needs appointments, written policies and QAPI coordination. An internal build uses your staff's time, and outside drafting support adds a writer and a gap assessment. IHS does not recommend one over the others.
What does it cost to build an infection prevention and stewardship program?
The regulation attaches no fee to having the programs. IHS scopes each engagement after a free introductory call. Scope moves with the number of hospitals and campuses, the services offered and how far your documents are from paragraphs (a) through (e). Budget your own staff time too, because your clinicians approve every clinical statement.