By Phenelle Segal, RN, CIC, FAPIC, Founder, Infection Control Consulting Services
Key Takeaways
Centers for Medicare & Medicaid Services (CMS) surveyors use the Ambulatory Surgical Center (ASC) Infection Control Surveyor Worksheet, Exhibit 351 of the State Operations Manual, to assess compliance with the infection control Condition for Coverage. The current version dates to June 2022.
The worksheet is built on observation. Surveyors follow at least one patient from registration to discharge and watch at least one procedure.
A single observed lapse is enough for a surveyor to mark a practice as deficient.
Injection practices, sterilization, and high-level disinfection make up the largest share of the worksheet's questions.
ASCs can run the worksheet as an internal audit, using surveyor methods, before any survey takes place.
In 2015, I wrote about the CMS revisions to the ASC Infection Control Surveyor Worksheet, known as the ICSW. That post still draws readers more than a decade later, which tells me surgery center leaders and infection preventionists keep returning to one question: What exactly will ASC surveyors look at? The worksheet has been revised since then. This post walks through the current version section by section, along with the areas where ASCs struggle during the mock surveys the team at ICCS conducts.
How CMS Uses the ASC Infection Control Surveyor Worksheet
The ICSW is Exhibit 351 of the CMS State Operations Manual. It translates the infection control Condition for Coverage at 42 CFR 416.51 into specific, observable practices. CMS last revised it in June 2022 (Revision 206).
During a CMS survey, which is typically conducted by the state survey agency, one surveyor is assigned to complete the worksheet, and every surveyor on the team is expected to watch for infection control breaches. That surveyor follows at least one patient from registration through discharge and observes at least one surgical procedure. For brief procedures such as colonoscopies, CMS prefers that surveyors follow at least two cases.
Observation drives the assessment, with interviews of the responsible staff as confirming evidence. In some cases, an interview answer alone can support a citation.
How Worksheet Answers Lead to Deficiency Citations
CMS sets a strict scoring standard. Surveyors are instructed that any single instance of a breach constitutes a breach for that practice. One missed hand hygiene step after glove removal, or one vial accessed with a previously used syringe, leads the surveyor to mark that practice "No."
Unless the worksheet states otherwise, a "No" answer in Part 2 is cited as a deficient practice under 42 CFR 416.51(a). Questions about the program itself tie to 416.51(b), including the requirement for a designated, qualified infection control professional. An ASC with no infection control program at all faces a condition-level deficiency.
When a surveyor cannot observe a practice, the worksheet requires a note explaining why and an attempt to assess it through interviews or document review. Tasks that do not occur during the survey still get evaluated, so written policies and logs serve as the evidence. When surveyors identify certain unsafe injection practices, such as syringe reuse, the state survey agency is expected to notify the state public health authority.
Part 1: Program Requirements and the Designated Professional
Part 1 collects basic facility information, then examines the program behind the practices. Surveyors ask:
Whether the program follows nationally recognized infection control guidelines
Whether a licensed health care professional with infection control training has been designated to direct the program, and whether that person is an employee or a contractor
Whether the designated professional is certified in infection control (CIC) and, if not, what training the person has received
How many hours per week that person spends on site directing the program
How the ASC identifies infections related to procedures performed there, and how it reports them as state law requires
What infection control training staff receive, and when
CMS does not require certification, but the ASC must be able to document the designated professional's training, and the absence of a designated professional can be cited at the condition level. The hours question carries more weight than many administrators expect. CMS sets no minimum, but it expects the designated professional to spend enough time on site to direct a program sized to the facility and its surgical volume.
Guideline selection matters just as much. When an ASC infection prevention plan names Centers for Disease Control and Prevention (CDC) guidelines but daily practice in the operating room departs from them, the plan gives surveyors a written standard to cite against.
Part 2: Infection Control Practices Under Observation
Part 2 covers five practice areas. Most questions are answered "Yes," "No," or "Unable to observe."
Hand Hygiene
Surveyors confirm that soap, water, and alcohol-based hand rub are readily accessible where staff need them, that staff perform hand hygiene at the right moments, and that gloves are used appropriately. Staff providing direct patient care may not wear artificial nails or extenders. Alcohol-based hand rub dispensers also have to be installed as the Life Safety Code requires. A lapse I see regularly is skipped hand hygiene before donning gloves and after glove removal.
Injection Safety and Multidose Vials
Surveyors check that a new needle and syringe are used for every vial entry and that single-dose vials are used for one patient only. IV bags and tubing can never be shared or used as a flush source for multiple patients. The rubber diaphragm of vials must be disinfected with alcohol before every entry, and medications drawn up in advance must be appropriately labeled. Surveyors also review sharps disposal.
Multidose vials get specific attention. Opened vials must be dated and discarded within 28 days unless the manufacturer specifies otherwise, and surveyors look at where vials are stored. A multidose vial that enters the immediate patient care area must be dedicated to a single patient and discarded immediately after use. The problems I tend to find cluster around anesthesia carts, where vials and pre-drawn syringes accumulate.
Sterilization, High-Level Disinfection, and Single-Use Devices
If an ASC reprocesses single-use devices, surveyors confirm that the devices are approved by the U.S. Food and Drug Administration (FDA) for reprocessing and that an FDA-approved reprocessor handles them. For sterilization, they review pre-cleaning against the manufacturer's instructions for use (IFU), physical, chemical indicator, and biological monitoring, sterile storage, and package integrity.
A dedicated subsection covers immediate-use steam sterilization (IUSS): the criteria for its use, the devices it may never be used on, such as implants, and whether it is performed routinely. Routine use of IUSS is cited as a deficient practice.
The high-level disinfection questions follow the same sequence as sterilization: pre-cleaning, disinfectant testing and management, contact time and temperature, drying, and storage. IFUs that staff cannot locate at the point of use and incomplete disinfectant test logs are findings I document regularly.
Environmental Cleaning
Surveyors confirm that operating rooms are cleaned and disinfected after each procedure with an Environmental Protection Agency (EPA)-registered disinfectant and terminally cleaned daily. Surfaces in other patient care areas must also be cleaned and disinfected with an EPA-registered product, and the ASC must have a procedure for decontaminating gross blood spills.
Point-of-Care Devices
This section applies only to ASCs that use point-of-care testing devices like blood glucose meters. Surveyors check hand hygiene and glove use during testing, single-use lancets, and cleaning and disinfection of shared devices between patients according to the manufacturer's instructions.
What Changed in the 2015 and 2022 Revisions of the ICSW
The 2015 update added the Unable to observe response, the IUSS subsection, the artificial nail requirement, alcohol disinfection of every vial septum, and beyond-use dating for pre-drawn medications. All of those provisions remain in effect.
The June 2022 revision, issued alongside updated surveyor guidance in Appendix L, consisted of what CMS called two non-substantive edits. It updated the list of CMS-recognized ASC accrediting organizations and clarified that the multidose vial questions in the injection practices section do not apply to multidose eye drop bottles.
How to Use the Infection Control Surveyor Worksheet as a Self-Assessment Tool
The worksheet is public, and every ASC should use it in preparation for surveys. The most useful approach mirrors the survey itself:
Trace a single case end to end instead of auditing each department separately
Watch instrument reprocessing and room turnover as they happen, then compare what you saw with the logs
Have someone from outside the department ask the interview questions
Record any single lapse as a "No," the way a surveyor would
Document each corrective action and recheck it
Final Thoughts
Most of what CMS surveyors checked in 2015, they still check today, and the same practices continue to generate findings. Because the ASC Infection Control Surveyor Worksheet is published, every item on it can be tested before a survey. ICCS uses the worksheet as the backbone of its ASC infection prevention consulting and builds its infection control mock surveys around it. Facilities that have already been cited can also turn to ICCS for plan of correction development.
Expecting a CMS survey? Contact ICCS to schedule an infection control mock survey built on the current worksheet.
Frequently Asked Questions About the ASC Infection Control Surveyor Worksheet
Where can ASCs find the current infection control surveyor worksheet?
CMS publishes it as Exhibit 351 of the State Operations Manual on cms.gov. The current version is Revision 206, issued in June 2022. Related surveyor guidance appears in Appendix L of the State Operations Manual.
Does a single observed lapse result in a citation?
Yes. CMS instructs surveyors that any single instance of a breach constitutes a breach for that practice, and a "No" answer in Part 2 of the worksheet is cited as a deficient practice under 42 CFR 416.51(a) unless the worksheet notes otherwise.
Do the worksheet's multidose vial questions apply to eye drops?
No. CMS's June 2022 revision added a note clarifying that the multidose vial questions relate to injection practices and do not apply to multidose eye drop bottles. Facilities should still follow manufacturer instructions and their own policies for eye drop use.