Exhibit 351 at a glance
What it is: Exhibit 351 is the Ambulatory Surgical Center (ASC) Infection Control Surveyor Worksheet.
When performing interviews and observations, items are to be assessed primarily by surveyor observation, with interviews used to provide additional confirming evidence of observations.
A filled-in Exhibit 351 example: a surveyor records one ASC on page 1
How to fill out Exhibit 351, box by box
ASC name, address and CMS Certification Number
Fill in 1. ASC Name and 2. Address, State and Zip Code, with the City, State and Zip.
Enter the 10-digit CMS Certification Number.
Opening year, site visit and previous survey dates
Enter 4. What year did the ASC open for operation, as y y y y.
Enter 5. Please list date(s) of site visit.
Enter 6. What was the date of the most recent previous federal (CMS) survey.
Medicare deemed status
Mark YES or NO for 7. Does the ASC participate in Medicare via accredited “deemed” status?
If YES, 7a. by which CMS-recognized accreditation organization(s): Accreditation Association for Ambulatory Health Care (AAAHC), American Associate for Accred. of Ambulatory Surgery Facilities (AAAASF), Accreditation Commission for Health Care (ACHC) or The Joint Commission (TJC).
If YES, 7b. according to the ASC, what was the date of the most recent accreditation survey.
Ownership, procedures and patients
8. What is the ownership of the facility? Select only ONE bubble: Physician-owned, Hospital-owned, National corporation (including joint ventures with physicians) or Other (please print).
9. What is the primary procedure performed at the ASC (i.e., what procedure type reflects the majority of procedures performed at the ASC)? Select only ONE bubble.
10. What additional procedures are performed at the ASC? Select all that apply. Do not include the procedure type indicated in question 9.
11. Who does the ASC perform procedures on? Select only ONE bubble: Pediatric patients only, Adult patients only or Both pediatric and adult patients.
The infection control program
If the ASC does not have an explicit infection control program (15), a condition-level deficiency related to 42 CFR 416.51 must be cited.
If the ASC does not follow nationally recognized infection control guidelines (16), a deficiency related to 42 CFR 416.51(b) must be cited; depending on the scope of the lack of compliance with national guidelines, a condition-level citation may also be appropriate.
If the ASC cannot document that it considered and selected specific guidelines for use in its infection control program (16a), a deficiency related to 42 CFR 416.51(b) must be cited.
This is the case even if the ASC's infection control practices comply with generally accepted standards of practice/national guidelines.
If the ASC neither selected any nationally recognized guidelines nor complies with generally accepted infection control standards of practice, then the ASC should be cited for a condition-level deficiency related to 42 CFR 416.51.
If YES to (a), 16b. which nationally-recognized infection control guidelines the ASC has selected for its program. Select all that apply.
17. Does the ASC have a licensed health care professional qualified through training in infection control and designated to direct the ASC's infection control program? If the ASC cannot document that it has designated a qualified professional with training (not necessarily certification) in infection control to direct its infection control program, a deficiency related to 42 CFR 416.51(b)(1) must be cited.
Lack of a designated professional responsible for infection control should be considered for citation of a condition-level deficiency related to 42 CFR 416.51.
If YES, 17a. Is this person an ASC employee or an ASC contractor. Select only ONE bubble.
17b. Is this person certified in infection control (i.e., CIC)? Note: §416.50(b)(1) does not require that the individual be certified in infection control.
Infection identification and staff training
If the ASC does not have a documented identification system (18) for infections that may have been related to procedures performed at the ASC, a deficiency related to 42 CFR 416.51(b)(3) must be cited.
If the ASC does not have supporting documentation, a deficiency related to 42 CFR 416.51(b)(3) must be cited.
If the ASC does not have a reporting system (18c), a deficiency must be cited related to 42 CFR 416.51(b)(3).
CMS does not specify the means for reporting; generally this would be done by the State health agency.
19. Do staff members receive infection control training? If training is completely absent, then consideration should be given to condition-level citation in relation to 42 CFR 416.51, particularly when the ASC's practices fail to comply with infection control standards of practice.
19d. Indicate frequency of staff infection control training. Select all that apply.
If training is not provided to appropriate staff upon hire/granting of privileges, with some refresher training thereafter, a deficiency must by cited in relation to 42 CFR 416.51(b) and (b)(3).
More rules for Exhibit 351
When performing interviews and observations, a minimum of one surgical procedure must be observed during the site visit.
When performing interviews and observations, the surveyor(s) must identify at least one patient and follow that case from registration to discharge to observe pertinent practices.
Citation instructions are provided throughout this instrument, indicating the applicable regulatory provision to be cited on the Form CMS-2567 when deficient practices are observed.
12. What is the average number of procedures performed at the ASC per month.
13. How many Operating Rooms (including procedure rooms) does the ASC have.
14. Please indicate how the following services are provided (fill in all that apply): Contract, Employee or Other, and if Other, please print.
20. How many procedures were observed during the site visit.
Please select ONE bubble for each “Was Practice Performed?” question, unless otherwise noted.
If N/A or unable to observe is selected as the response, please explain why there is no associated observation, or why the question is not applicable, in the surveyor notes box.
Multi-dose vials are dated when they are first opened and discarded within 28 days unless the manufacturer specifies a different (shorter or longer) date for that opened vial.
Sources
[1] Exhibit 351 (Rev. 206; 06-21-22), Ambulatory Surgical Center (ASC) Infection Control Surveyor Worksheet, Centers for Medicare & Medicaid Services (the Official source link on this page).