Meeting cms requirements for infection prevention in ambulatory surgery centers
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Meeting CMS Requirements for Infection Prevention in Ambulatory Surgery Centers. September 18, 2012 APIC Badger Chapter Madison, WI Presenter: Judy Hintzman RN MS CIC. Objectives. Understand the elements of infection prevention and control in ambulatory settings surveyed by CMS.

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Meeting CMS Requirements for Infection Prevention in Ambulatory Surgery Centers

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Meeting CMS Requirements for Infection Prevention in Ambulatory Surgery Centers

September 18, 2012

APIC Badger Chapter

Madison, WI


Judy Hintzman RN MS CIC


  • Understand the elements of infection prevention and control in ambulatory settings surveyed by CMS.

  • Describe how to perform a facility risk assessment.

  • Identify the initial steps in implementing change in your organization.

Centers for Medicare and Medicaid Services (CMS)

  • Federal agency that administers:

    • Medicare and Medicaid

    • HIPAA

  • Enforces federal quality standards for various healthcare settings

  • Maintains oversight of ASC’s, long term care facilities, home health agencies, intermediate care facilities, mental health facilities and hospitals

  • Administers Quality Improvement Organizations at state level

What Led to the Focus on Infection Control in ASCs?

  • Cluster of Hepatitis C virus infections (Nevada) related to endoscopy procedures

  • Survey of that ASC identified unsafe injection practices resulting in 40,000+ patients notified of potential exposure.

  • Nevada also identified other ASCs with deficient infection control practices.

  • CDC has reported other outbreaks related to bloodborne infectious diseases in other states.

CMS Conditions for CoverageInfection Control Requirements 5/18/09

  • 416.51 Infection Control The ASC must maintain an infection control program that seeks to minimize infections and communicable diseases.

    • Standard A :Sanitary Environment “The ASC must provide a functional and sanitary environment for the provision of surgical services by adhering to professionally acceptable standards of practice.”

CMS Conditions for CoverageInfection Control Requirements 5/18/09

Standard B: Infection control program. “The ASC must maintain an ongoing program designed to prevent, control, and investigate infections and communicable diseases. In addition, the infection control and prevention program must include documentation that the ASC has considered, selected, and implemented nationally recognized infection control guidelines.

CMS Conditions for CoverageInfection Control Requirements 5/18/09

The program is

(1) Under the direction of a designated and qualified professional who has training in infection control

(2) An integral part of the ASC’s quality assessment and performance improvement program

CMS Conditions for CoverageInfection Control Requirements 5/18/09

The program Is

(3) Responsible for providing a plan of action for preventing, identifying, and managing infections and communicable diseases and for immediately implementing corrective and preventive measures that result in improvement.

What is an Ambulatory Surgical Center or ASC (per CMS)?

  • Any entity that operates exclusively for the purpose of providing surgical services to patients not requiring hospitalization

  • Duration of services not expected to exceed 24 hours

What is Surgery per CMS?

  • Procedure performed for purpose of structurally altering the human body by incision or destruction of tissues.

  • Diagnostic or therapeutic treatment of conditions or disease processes by any instruments causing localized alteration or transposition of live human tissue which includes lasers, ultrasound, ionizing radiation, scalpels, probes and needles. Endoscopy is included in definition.

  • Injections of substances into body cavities, internal organs, joints, sensory organs, and the central nervous system.

The ASC Survey Process for CMS

  • Certification accomplished through

    • Observations and tours

    • Interviews

    • Document and record reviews

Survey ProcessNo more “drive by” CMS surveys October 2009 - first training in 10 years

  • Focus on staff that do procedures

  • Case tracer methodology

    • Surveyors required to follow at least one patient from admission, through surgery and recovery, to discharge.

  • Infection control surveyor worksheet is used to collect information (16 pages)

Accreditation StandardsMust be met to receive accreditation

  • Government regulations- CMS - OSHA

  • ASC accrediting agencies

    • AAAHC Accreditation Association for Ambulatory Health Care

    • AAAASF American Association for Accreditation for Ambulatory Surgery Facilities

    • AOA American Osteopathic Association

  • Best practices – may become standard of care

  • Guidance documents


      • Environmental Infection control

        • Terminal cleaning of OR room

      • Prevention of Surgical Site Infection

        • Have you read CDC document?

        • How is information shared when SSI’s are identified?

      • Hand Hygiene

        • Have you read the CDC document?

        • Have you done observation studies on compliance?

Infection Prevention Program Required Elements

  • Written plan

  • Risk assessment

  • Qualified licensed professional to direct the program

    • Education in Infection Prevention is documented

    • Can be certified but not required

  • Selection of nationally recognized guidelines

    • Available to staff and current

  • Evidence of compliance with guidelines

  • Surveillance system including notifiable disease reporting to State

  • Staff education and training

    • Must have an annual plan

    • Documented training

CMS ASCInfection Control Worksheet (ICWS)

  • Initial tool developed by CDC as part of Nevada Outbreak investigation

  • $10 million funding made it possible to increase ASC’s surveys and implement process nation wide

  • Some accreditation organizations are also using the ICWS

  • Original goal: collect ICWS from 1500 ASCs

CMS Survey Outcomes

  • No Deficiency

  • Standard Level

  • Condition Level

  • Immediate Jeopardy

Focus on Specific Infection Prevention Practices

  • Hand Hygiene (including glove use)

  • Safe injection practices (including use of medication vials)

  • Disinfection and sterilization

  • Environmental infection control

  • Safe use and handling of point of care devices

ASCs Characteristics Sample Questions

1) ASC name:

2) Address:

3) 10-digit CMS Certification Number:

4) What year did the ASC open for operation?

ASCs Characteristics Sample Questions

What is the primary procedure performed at the ASC (i.e.,what procedure type reflects the majority of procedures performed at the ASC). Check only ONE:

 Dental  Orthopedic

 Endoscopy  Pain

 Ear/Nose/Throat  Plastic/reconstructive

 OB/GYN  Podiatry

 Ophthalmologic Other

ASCs Characteristics Sample Questions

What additional procedures are performed at the ASC (Check all that apply)?

Dental  Orthopedic

 Endoscopy  Pain

 Ear/Nose/Throat  Plastic/reconstructive

 OB/GYN Podiatry

 Ophthalmologic  Other ____________

ASCs Characteristics Sample Questions

Who does the ASC perform procedures on? (Check only ONE):

 Pediatric patients only

 Adult patients only

 Both pediatric and adult patients

ASCs Characteristics Sample Questions

What is the average number of procedures performed at the ASC per month?

How many Operating Rooms (including procedure rooms) does the ASC have?

# of rooms

# actively maintained

ASCs Characteristics Sample Questions

Please indicate how the following services are provided (check all that apply):

AnesthesiaContract  Employee  Other____

Environmental CleaningContract  Employee  Other ____

LinenContract  Employee  Other ____

NursingContract  Employee  Other ____

PharmacyContract  Employee  Other ____

Sterilization/ReprocessingContract  Employee  Other ____

Waste ManagementContract  Employee  Other ____

Worksheet Standard Assessment

Does the ASC have an explicit infection control program?  YES  NO

NOTE! If the ASC does not have an explicit infection control program, a condition-level deficiency related to 42 CFR 416.51 must be cited.

Worksheet Standard Assessment

Does the ASC’s infection control program follow nationally recognized infection control guidelines?

 YES  NO

NOTE! If the ASC does not follow nationally recognized infection control guidelines, 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.

Worksheet Standard Assessment

Is there documentation that the ASC considered and selected nationally-recognized infection control guidelines for its program?

 YES  NO

Worksheet Standard Assessment

Which nationally-recognized infection control guidelines has the ASC selected for its program (Check all that apply)?

NOTE! If the ASC cannot document that it considered and selected specific guidelines for use in its infection control program, 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

Worksheet Standard Assessment

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?

 YES  NO

is this person an: (check only ONE):

 ASC employee

 ASC contractor

Worksheet Standard Assessment

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.)

 YES  NO

If this person is NOT certified in infection control, what type of infection control training has this person received?

Worksheet Standard Assessment

On average how many hours per week does this person spend in the ASC directing the infection control program?

Note: §416.51(b)(1) does not specify the amount of time the person must spend in the ASC directing the infection control program, but it is expected that the designated individual spends sufficient time directing the program, taking into consideration the size of the ASC and the volume of its surgical activity.)

How Many IC Hours per Week?

  • Does not specify

  • The amount of time needed to direct the program is relative to the size and scope of service

    • Judy’s thoughts - at least 3 times a week- 4 hours per day until the program is established. There is lots to do!

Worksheet Standard Assessment

Does the ASC have a system to actively identify infections that may have been related to procedures performed at the ASC?  YES  NO

If YES, how does the ASC obtain this information?

  • Sends e-mails to patients' after discharge.

  • Follows up with patients’ primary provider after discharge.

  • Relies on the surgeon at a follow up visit to report

  • Other

Worksheet Standard Assessment

Is there supporting documentation confirming this tracking activity?

 YES  NO

Worksheet Standard Assessment

Does the ASC have a policy/procedure in place to comply with State notifiable disease reporting requirements?

 YES  NO

Worksheet Standard Assessment

Do staff members receive infection control training?

 YES  NO


How do they receive infection control training (check all that apply)?

 In-service

 Computer-based training

 Other (specify)

Worksheet Standard Assessment

Which staff members receive infection control training? (check all that apply):

 Medical staff

 Nursing staff

 Other staff providing direct patient care

  • Staff responsible for on-site sterilization/high-

    level disinfection

     Cleaning staff

     Other (specify):

Worksheet Standard Assessment

  • Is training:

    • The same for all categories of staff ?

    • Different for different categories of staff ?

Worksheet Standard Assessment

Indicate frequency of staff infection control training (check all that apply):

 Upon hire

 Annually

 Periodically/as needed

  • Other (specify)

Survey Process

  • Tracer methodology

  • Focus on staff who perform procedures

    • Injection practices: nurses & physicians

    • Instrument reprocessing: reprocessing technicians

Hand Hygiene

  • Challenging to assess

  • Observations in patient-care areas

    • Pre-operative area

    • Post-operative area

  • Focus on:

    • Nurses

    • Physicians

Hand Hygiene

  • Soap and water available

  • Alcohol-based hand rubs available and installed as required

  • Staff perform hand hygiene correctly

    • After removing gloves

    • After direct patient contact

    • Before performing invasive procedure

Glove Use

  • Healthcare providers should wear (non-sterile) gloves:

    • For procedures that might involve contact with blood or body fluids

    • When handling potentially contaminated patient equipment

  • Healthcare providers should remove gloves (and immediately perform hand hygiene) before moving to the next task and/or patient

Gloves: Common Mistakes Seen

  • Failure to clean hands after gloves removed.

  • Moving from patient to patient without cleaning hands and changing gloves

  • Using alcohol based hand rub on gloves

  • Thinking double gloving protects against puncture injury

  • Not having gloves accessible in locations where they are needed/ and used.

Injection SafetyInjectable medications, saline, other infusates

  • Observations in patient care and medication preparation areas

    • Pre-operative area

    • Operating/Procedure rooms

      • Anesthesia cart

  • Focus on:

    • Nurses (e.g., RN, CRNA)

    • Physicians (e.g., anesthesiologists)

Injection Practices

Needles are used for only one patient

Syringes are used for only one patient

Medication vials are always entered with:

New needle

New syringe

Injection Safety

Single-dose medication vials

Manufacturer-prefilled syringes

Bags of IV solution

Medication administration tubing and connectors

Handling of Single-dose Medications and Supplies

Handling of Multi-dose Medications

  • Rubber diaphragm is disinfected with alcohol

    prior to each entry.

  • Vials are dated when opened and discarded within 28 days or according to manufacturer instructions, whichever comes first

  • Vials are not stored or accessed in the immediate areas where direct patient contact occurs (e.g., at patient bedside)

Label Requirements are Strictly Enforced

  • Medications that are pre drawn are labeled with the time of draw, initials of the person drawing, medication name, strength and expiration date or time.

  • There are NO acceptable “work arounds” or substitute practices to avoid using a label.

Inspection Of Multi-Dose VialsNeed a policy and assure practice

  • Multi-dose vials used on >1 patient

    • Vial septum disinfected with alcohol before entry

    • New needle and syringe for each access

    • Vials are dated when opened and discarded in 28 days or manufacturer’s expiration date, which ever comes first.

    • Reminder: single dose and multi-dose vials are not interchangeable.

    • Drug cost/availability does not justify doing so.

Surveyors will look in more than one place for injection safety deficiencies

  • Important Reminders

    • Per CDC, medications should be drawn up as close to the point of use as possible

    • Do not “carry over” pre drawn syringes from one day to the next, discard at the end of the day.

    • Do not spike your IV bags and sets before they will be used

    • NEVER use a bag of saline to pre fill syringes

    • NEVER combine the “leftover” contents in partially used vials.

A frequently asked question….Do CMS and CDC permit incremental dosing? YES but only when…

  • Same syringe, same drug

  • Required intra-operatively

  • No opportunity to reuse with another patient

  • Anesthesia: most common scenario



  • Pre cleaned

  • Visually inspected

  • Chemical indicator is used

  • Biologic indicator is performed at least weekly

  • Documentation for each sterilizer is maintained and up to date and includes results from each load

Flash Sterilization Update

  • Past Definition: very short cycle for small and unwrapped load.

  • Sterilization of unwrapped/uncontained loads should be used for urgent and unpredicted need (e.g. dropped instrument).

  • Routine sterilization of unwrapped/uncontained loads is inappropriate and will be cited as a violation by CMS.

Short Sterilization Cycle (Flash Sterilization)

  • Short sterilization cycle of wrapped/contained load is OK

  • Requirements

    • Sterilizers cleared by FDA to run short cycles

    • Validated by manufacturer’s to perform effectively in those cycles for defined validation loads.

Short Sterilization CycleSurveyor will ask these questions.

  • Is sterilizer labeled for this cycle by manufacturer?

  • What is the manufacturer-recommended load for that cycle?

  • Is the containment device used labeled by manufacturer for use in that cycle?

  • For what load is the containment device recommended by its manufacturer?

  • Is the chemical indicator (and biological if used) labeled for use for this cycle by the manufacturer?

  • If the cycle is used frequently, is it checked regularly with a biological indicator?

Short Sterilization Cycle

  • Factors to consider that will influence outcome

    • Weight and complexity of materials in the load

    • Presence or absence of fabric in load

    • Presence or absence of lumens

Short Sterilization Cycle

  • If manufacturer’s instructions are not followed , then the outcome of the sterilizer cycle is guesswork, and the ASC’s practices will be cited as a violation.

  • Surveyors will also observe whether adequate pre cleaning is being performed with water and detergent or water and enzymatic cleaners.

High Level Disinfection

  • Semi critical equipment is high level disinfected or sterilized

  • Items are pre cleaned and visually inspected

  • Equipment is maintained

  • Chemicals are prepared, tested and replaced according to manufacturer’s recommendations.

  • Items are allowed to dry before use

  • Items are stored in designated clean area

JCAHO:Guidance on Laryngoscope Blades

  • Per CDC Laryngoscope blades are “semi critical” items. They should be sterilized or high level disinfected before reuse.

  • Stored in a way to prevent recontamination.

  • Examples of non compliant storage

    • Unwrapped blades in an anesthesia drawer or top of a code cart

  • Examples of compliant storage

    • Peel pack (long term)

    • Wrapping in sterile towel (short term)

JCAHO:Guidance on Laryngoscope Blades

  • Laryngoscope handles must be processed prior to use on next patient.

  • Follow manufacturer’s recommendations

    • Low level disinfectant on surface of handle

    • Check with state for additional law or regulation.

Environmental Infection Control

Point of Care Devices

  • Observation in:

    • Pre-operative area

    • Post-operative area

  • Focus on:

    • Nurses

A new single-use, auto-disabling lancing device is used for each patient

Glucose TestingFinger stick Devices

Glucose TestingFingerstick Devices

Lancing penlet devices should NOT be used for multiple patients

Point of Care Devices

Glucometer is not used on more than one patient unless manufacturer’s instructions indicate this is permissible

Glucometer is cleaned and disinfected after every use


CMS Visits To Date in Wisconsin

  • 9/1/11- 8/31/12

    • 30 surveys

  • 1/1/12-8/31/12

    • 19 surveys

Problem Prone Areas:Sanitary Environment- must provide a sanitary environment by following professionally acceptable standards of practice.

  • Floors not clean

  • Food prepared next to hand washing sinks and sharps containers

  • Refrigerator/freezer temps not monitored

  • Walls chipped

  • Wet OR floors with blood/body fluids tracked outside OR suites

Problem Prone Areas:Infection Control Program

  • ASC has not decided on what nationally recognized standards will be followed.

  • Hand washing/gloving by all staff

  • Eye shields not worn in surgery

  • Leaving the OR, going outside, reentering the OR without changing scrubs.

  • Using glucose meters not for multiple patient use

  • Enzymatic cleaner and water concentrations not measured per manufactures directions.

Problem Prone Areas:Infection Control Program

  • Sterile field broken-back to instrument table

  • Staff not screened for infections and communicable diseases (TB, Rubella, Hepatitis)

  • Recapping of needles two handed

  • Oxygen tubing ready to use open to air

  • CSS door propped open to hallways

  • Boxes of patient supplies stored on floors

Problem Prone Areas:Infection Control Program

  • Flash sterilization used daily/frequently due to lack of appropriate number of instrument trays

  • Lack of infection control program and active surveillance

  • Using hand sanitizers on gloved hands

  • Cross contamination between clean and dirty

Problem Prone Areas:Program under direction of a qualified professional

  • No one assigned by governing body who will lead the ASC IC program

  • Not qualified

  • Not enough time dedicated to do the job

  • No training or on going education

Problem Prone AreasIC Director is responsible for plan of action for preventing, identifying, and managing infections and for implementing corrective/preventive measures that result in improvement

  • ASC does not have active surveillance to ensure a sanitary environment and staff adherence to IC policies and current standards of practice

  • Anesthesia/medical staff not included as part of active surveillance

  • Not assessing the risks of type of procedures performed and type of staff who work in ASC

  • Collection of data without analysis and action plans related to post op infections

  • Does not have P&P related to disease reporting to health departments.

Problem Prone Area The IC program is an integral part of the ASC’s quality assessment and performance improvement program

  • The ASC does not include measure/indicators and activities to IC into the QAPI program which governs all their patients

  • No evidence that IC activities result in actions designed to improve IC within the ASC

    • Judy’s passion is to show that all of our hard work actually improved patient care!

Elements of the Infection Surveillance, Prevention & Control Program

  • Written Infection Prevention & Control Plan

  • Risk Assessment

  • Authority statement

  • IC Service Description

  • Surveillance Plan

  • Goals & Objectives

  • Prevention & Control Strategies

  • Communications & Reporting

  • Emergency Management & Planning

  • Education

  • Evaluation of Program Effectiveness

Facility Risk AssessmentShould be done annually

  • Provides a basis for IP activities/annual surveillance plan

    • What populations do you serve?

    • What communicable diseases are in the community?

    • TB risk assessment must be done annually.

  • Identify high risk populations in your facility

    • High volume, high risk, or problem prone procedures

  • Assist in focusing surveillance efforts

  • Meet regulatory requirements

    • Example: OSHA requires biohazard waste to be contained and labeled correctly.

Facility Risk Assessment

  • Introduction

    • Identify who developed the document with collaboration from other team members (list)

  • Geographic location/ community environment/ demographics

    • List counties, community issues and patients served

  • Care, treatment and services provided

    • Describe physical plant (OR’s, Endo, procedures done)

Facility Risk Assessment cont.

  • List characteristics that increase risk

    • High volume cases, high risk procedures, implants

    • Community outbreaks

    • Resistant bacteria

    • Identify any area that needs to be improved.

  • List characteristics that decrease risk

    • Education of staff to prevent infection

    • Identify improvements/implementations

    • Increased hand hygiene compliance

    • Use of PPE especially gloves

    • Follow CDC guidelines to prevent SSI

      • Timing of antibiotics

      • No razors

Resources: Facility Risk Assessment

  • Becker’s ASC Review @

  • Using an Infection Control Risk Assessment to Create an Infection Control Plan @

  • Association of Wisconsin Surgery Centers, Inc. (WISCA) Course scheduled December 2012 @

Facility TB Risk Assessment

  • Risk assessment form specific for ambulatory care:

    • APIC Infection Prevention Manual for Ambulatory Care 2009 Section 9.

  • Follow State Law

  • Screen everyone on hire

    • Medium risk: annual screening

    • Low risk: no additional screening unless exposure occurs

Authority Statement Must be Written

  • The Board of Directors (Medical Director/Quality Committee) authorizes and supports the Director (Manager/etc.) of Infection Prevention to institute appropriate infection control measures within the facility. This includes authority to employ whatever methods necessary when, in their judgment, there is reasonable possibility of immediate danger to any patient's), personnel or others in the facility.

Surveillance PlanShould be done annually

  • How: surveillance methodology

    • How will data be collected?

  • What indicators and events will be counted?

    • Outcome monitors

      • Surgical site Infections

    • Process monitors

      • Hand Hygiene rate

      • Influenza immunization rates

      • Terminal cleaning done correctly

  • Why: reduce risk – improve patient care

  • Comparative databases should be used

  • Outbreak identification and response should be planned

Healthcare Associated Surgical Site Infections (SSI)

  • Definition of SSI should be written and utilized- provide definitions to surgeons.

  • Surveillance system must be in place to identify and evaluate every infection

    • Develop a process for case finding (patient education should include signs and symptoms to look for and emphasize infection prevention strategies)

    • Record variables for every procedure being monitored (surgical wound class, ASA classification, duration of operation)

    • Report SSI info to the surgical team on a routine basis (quarterly) and as each case occurs.

Healthcare Associated Surgical Site Infections (SSI)

  • Data collection should include

    • Basic demographics (name, MR number, age, gender, date of procedure)

    • Infection information (date of onset, site of infection, microorganisms)

    • Clinical information ( signs and symptoms present)

    • Laboratory information (date of culture, result)

    • Antibiotic therapy (preop, therapeutic)

    • Surgery information (date, start and stop times, surgeon, wound classification, and severity of illness ASA score )

    • Procedure information (type, date)

    • Predisposing factors( (diabetes, steroids, skin issues)

Use Nationally Recognized Guidelines to Reduce Risk of Surgery-Related Infections

  • Antibiotics: administered right time, right antibiotic and discontinued appropriately after surgery.

  • Aseptic technique

  • Blood sugar control

  • Pre op showers

  • No shaving whenever possible

  • No razors!

Implementing Change in your Organization

  • First Steps

    • Conduct your risk assessment

    • Prioritize the needs of your organization

Implementing Change in your Organization

  • Do not try to fix everything all at once.

  • Make a list of available resources you already have.

  • Identify what you do already?

  • Identify a champion who can help.

  • Identify small group of influential leaders committed to patient safety who can help

  • Develop a plan of action (1-2 years)

Advice from Judy

  • Meet with leadership-get support ASAP

  • Identify the amount of time needed to accomplish all that must be done- stick to it!

  • Create a plan of action ( 3 month , 6 month, 12 month)

  • Join APIC chapter

  • Obtain necessary references to do the job

    • Infection Control in Ambulatory Care 2004

    • Infection Prevention Manual for Ambulatory care 2009

  • Develop a Facility Risk Assessment ASAP

  • Develop a Surveillance Plan ASAP

What Are Some Barriers To Change?

  • Unexpected changes in external conditions

  • A lack of commitment in implementation

  • Resistance of people involved

  • Lack of resources

  • Conflicting goals or priorities

How Can You Make Change Happen?

  • Before implementing change, you need to convince people that change is needed

  • Never, never underestimate the power of complacency

Skills Needed to Lead Change

  • Commitment to the plan

  • Realistic goal setting

  • Communication skills

  • Flexibility

  • Ability to stimulate motivation in others

  • Follow through


  • The CMS regulations are a golden opportunity to improve patient safety in the ambulatory surgery setting, as well as employee safety.

  • The emphasis on medication and injection safety and processing instruments and scopes is appropriate.

  • This work will make a difference!


  • Thank You!

    Judy Hintzman RN MS CIC Infection Preventionist

    [email protected]


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