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Infection Control Program. Infection Control Program. § 416.51 The ASC Infection Control Program must: Provide a functional and sanitary environment for surgical services, to avoid sources and transmission of infections and communicable diseases;

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Infection Control Program

  • §416.51

  • The ASC Infection Control Program must:

    • Provide a functional and sanitary environment for surgical services, to avoid sources and transmission of infections and communicable diseases;

    • Be based on nationally recognized infection control guidelines;

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Infection Control Program (cont)

  • Be directed by a designated healthcare professional

  • Be integrated into ASC’s QAPI program;

  • Be ongoing

  • Include actions to prevent, identify and manage infections and communicable diseases, and

  • Include mechanism to immediately implement corrective actions and preventive measures to improve the control of infection within the ASC.

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Infection Control Program

  • § 416.51

  • The ASC must maintain an explicit infection control program

  • The program is responsible for providing a plan of action for preventing, identifying, and managing infections and communicable diseases.

    • The plan of action must include mechanisms that result in immediate action to take preventive or corrective measures that improve the ASC infection control program.

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Activities of Infection Control Program

  • Development and implementation of infection control measures related to personnel

  • Identifying infections

  • Monitoring infection control program compliance and plan evaluation

  • Active surveillance

  • Compliance with reportable disease requirements of local health authorities

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Minnesota Department of HealthInfectious Disease Epidemiology, Prevention and Control

  • 651-201-5414 or 1-877-676-5414


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Infection Control Guidelines

  • 42 CFR 416.51

  • The infection control program must include documentation that the ASC has considered, selected, and implemented nationally recognized infection control guidelines

  • Follow nationally recognized infection control guidelines

  • Documentation that the ASC considered and selected national-recognized infection control guidelines for its program

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Condition of Coverage-Infection Control Program

  • Examples of national recognized organizations include:

  • Centers for Disease Control and Prevention(CDC)

  • Associations for Professional in Infection Control and Epidemermiology (APIC)

  • Society for Healthcare Epidemiology of America (SHEA)

  • Association of Peri-Operative Registered Nurses

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Infection Control Program Designee

  • §42 CFR 416.51 (b) (1)

  • The ASC must designate in writing, a qualified licensed health professional with training, who will lead the facility’s infection control program

  • Leadership must be on-site

    −Consultant may be used

    − On-site time not specified: must be sufficient to ASC’s program size

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System to Identify Infections

  • § 416.51 (b) (3)§ 416.44 (a) (3)

  • System to identify infections that may be related to procedures performed at the ASC

    • Follow up with primary care providers

    • Physician performing the procedure obtains information and reports to ASC

    • Contact with patient following discharge

      • Emails

      • Phone call

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ASC Personnel

  • § 416.51 (b)

  • Infection Control training for staff

    • Frequency

    • Same categories

    • Documentation of training

  • Evaluating ASC staff immunization status

  • Policies articulating when infected ASC staff are restricted from direct patient care

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Infection Control and Related Practices

  • Hand Hygiene

  • Injection Practices

  • Single Use Devices

  • Point of Care Devices (e.g. blood glucose monitors)

  • Sterilization

  • High–Level Disinfection

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Hand Hygiene

  • §416.51 (a)

  • Staff perform hand hygiene:

    • After removing gloves

    • After direct patient care

    • After contact with blood, body fluids or contaminated surfaces (even if gloves are worn).

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Injection Practices

  • §416.48(a)

  • Needles are used for only one patient

  • Syringes are used for only one patient

  • Medication vials are always entered with a new needle

  • Manufactured prefilled syringes are used for only one patient

  • Multi-dose medications, used for more than one patient, are not stored or accessed in the immediate areas where direct patient care occurs

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Injection Practices (cont)

  • Multi-dose medications used for more than one patient are dated when opened and discarded within 28 days or according to manufactures recommendations, whichever comes first

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Single Use Devices

  • §416.44(a)

  • Single use devices are reprocessed

    • Approved by FDA for reprocessing

    • Reprocessed by an FDA-approved preprocessor.

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Point of Care Devices

  • Manufacturer’s instructions indicate more than one patient use

  • Device is cleaned and disinfected before each use

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Flash Sterilization

  • §416.51(a)

  • S&C Program Memo-09-55

  • Sterilization of unwrapped/uncontained loads should not be routine practice in ASCs but should be used for an urgent and unpredicted need for a specific device

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High –Level Disinfection

  • High-level disinfection equipment should be maintained according to manufacturer instructions

  • Chemicals for high-level disinfection must

    • Be prepared appropriately

    • Be tested for appropriate concentration

    • Be replaced appropriately

    • Have documentation of preparation and replacement

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High-level Disinfection (cont)

  • Equipment subject to high-level disinfection is:

    • Disinfected for appropriate amount of time

    • Disinfected at the correct temperature

    • Allowed to air dry before use

    • Stored in a designated clean area

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Patient Admission Assessment and Discharge

  • §416.52

  • The ASC must ensure each patient has the appropriate pre-surgical and post-surgical assessments complete and that all elements of the discharge requirements are complete