Centers for Medicare and
Medicaid Services
Audit Tool Components
for Ambulatory Surgical
Facilities
Patient Safety in the Ambulatory Surgical Setting
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Hand Hygiene—Centers for Medicare and
Medicaid Services (CMS) Requirements
• Staff to perform hand hygiene:
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–
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–
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After removing gloves
After direct patient contact
Before performing invasive procedures
After contact with blood, body fluids, or
contaminated surfaces (even if gloves are worn)
Hand Hygiene—CMS Requirements
• Hand hygiene supplies in patient care
areas include the following:
– Availability of sinks with soap, water, and
paper towels in all patient care areas
– Installation and availability of alcohol-based
handrub, according to Life Safety Code®
requirements
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Handwashing
Policy
When hands are visibly dirty or contaminated with blood or other
body fluids, perform hand hygiene with soap and water.
Procedure
• Turn on water to a comfortable warm temperature.
• Moisten hands with soap and water and make a heavy lather.
• Wash well under running water for a minimum of 15 to 30
seconds, using friction.
• Rinse hands well under running water.
• Dry hands with a clean paper towel.
• Use the paper towel to turn off the faucet, then discard the towel.
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Hand Hygiene—Alcohol-Based Handrub
• If hands are not visibly soiled, use an alcohol-based
handrub for routinely decontaminating hands in all
clinical situations other than those listed under
“Handwashing.”
• When decontaminating hands with an alcoholbased handrub, apply product to palm of one hand
and rub hands together, covering all surfaces of
hands and fingers until hands are dry.
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Hand Hygiene—Alcohol-Based Handrub
• Follow the manufacturer’s recommendations
regarding the volume of product to use.
• Alcohol-based handrubs are not sporicidal.
• Consider washing hands with soap and water if
contact with spores (e.g., Clostridium difficile) is
likely to have occurred. The physical action of
washing and rinsing hands, if done appropriately,
will likely remove spores from the surface of the
hands.
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Hand Hygiene—Glove Usage
CMS requires the following:
• Wear gloves for procedures that might involve
contact with blood and body fluids.
• Wear gloves when handling potentially
contaminated equipment.
• Remove gloves when moving to the next task or
patient.
• Monitor hand hygiene by observing staff who are
directly involved in patient care (e.g., physicians,
nurses) (monitoring tool provided).
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Safe Injection Practices—CMS Requirements
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•
•
•
•
Needles are used for only one patient.
Syringes are used for only one patient.
Medication vials are always entered with a new needle.
Medication vials are always entered with a new syringe.
Medications that are predrawn are labeled with the time of
draw, initials of the person drawing, medication name,
strength, and expiration date or time.
• Single-dose (single-use) medication vials are used for only
one patient.
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Safe Injection Practices—CMS Requirements
• Manufactured prefilled syringes are used for only one
patient.
• Bags of intravenous solution are used for only one patient.
• Medication administration tubing and connectors are used
for only one patient.
• Multidose injectable medications are used for only one
patient.
• The rubber septum on a multidose vial used for more than
one patient is disinfected with alcohol prior to each entry.
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Safe Injection Practices—CMS Requirements
• Multidose medications used for more than one patient are
dated when they are first opened and discarded within 28
days of opening or according to manufacturer’s
recommendations, whichever comes first.
• Multidose medications used for more than one patient, are
not stored or accessed in the immediate areas where direct
patient contact occurs.
• All sharps are disposed of in a puncture-resistant sharps
container.
• Sharps containers are replaced when the fill line is reached.
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Single-Use Devices, Sterilization, and HighLevel Disinfection—CMS Requirements
• Precleaning must always be performed prior to
sterilization and high-level disinfection.
• Sterilization must be performed for critical
equipment (i.e., instruments and equipment that
enter normally sterile tissue or the vascular
system, such as surgical instruments).
• High-level disinfection must be performed for
semicritical equipment (i.e., items that come into
contact with nonintact skin or mucous
membranes, such as reusable flexible endoscopes
and laryngoscope blades).
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Single-Use Devices—CMS Requirements
• If single-use devices are reprocessed, they are
devices that are:
– Approved by the U.S Food and Drug
Administration (FDA) for reprocessing
– Reprocessed by an FDA-approved
reprocessor
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Sterilization—CMS Requirements
• Critical equipment is sterilized.
• Items are precleaned according to manufacturer’s
instructions or evidence-based guidelines prior to
sterilization.
• Medical devices and instruments are visually inspected for
residual soil and recleaned as needed before packaging and
sterilization.
• Method of sterilization is defined (e.g., steam autoclave,
peracetic acid).
• A chemical indicator is placed in each load.
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Sterilization—CMS Requirements
• A biologic indicator is performed at least weekly and with all
implantable loads.
• Each load is monitored with mechanical indicators (e.g., time,
temperature, pressure).
• Documentation for each piece of sterilization equipment is
maintained and up to date and includes results from each
load.
• Items are appropriately contained and handled during the
sterilization process to ensure that sterility is not
compromised prior to use.
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Sterilization—CMS Requirements
• After sterilization, medical devices and
instruments are stored in a designated
clean area so that sterility is not
compromised.
• Sterile packages are inspected for
integrity, and compromised packages are
reprocessed.
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High-Level Disinfection—CMS Requirements
• Semicritical equipment is high-level disinfected or sterilized.
• Method of high-level disinfection is specified, such as
manual, automated, or other processes.
• Items are precleaned according to manufacturer’s
instructions or evidence-based guidelines prior to high-level
disinfection.
• Medical devices and instruments are visually inspected for
residual soil and recleaned as needed before high-level
disinfection.
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High-Level Disinfection —CMS Requirements
• High-level disinfection equipment is maintained
according to manufacturer instructions.
• Chemicals used for high-level disinfection are:
– Prepared according to manufacturer instructions
– Tested for appropriate concentration according to
manufacturer’s instructions
– Replaced according to manufacturer’s instructions
– Documented to have been prepared and replaced
according to manufacturer’s instructions
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High-Level Disinfection—CMS Requirements
• Instruments requiring high-level disinfection are:
– Disinfected for the appropriate length of time as specified
by manufacturer’s instructions or evidence-based
guidelines
– Disinfected at the appropriate temperature as specified
by manufacturer’s instructions or evidence-based
guidelines
• Items that undergo high-level disinfection are allowed to dry
before use.
• Following high-level disinfection, items are stored in a
designated clean area in a manner to prevent contamination.
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Point-of-Care Devices (e.g., blood glucose meter)—
CMS Requirements
• A new single-use, auto-disabling lancing
device is used for each patient.
• The glucose meter is not used on more than
one patient unless the manufacturer’s
instructions indicate this is permissible.
• The glucose meter is cleaned and disinfected
after every use.
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Environmental Cleaning—CMS Requirements
• Observations are to be made of staff who perform
environmental cleaning (e.g., surgical technicians, cleaning
staff).
• Operating rooms (OR) are cleaned and disinfected after each
surgical or invasive procedure with an Environmental
Protection Agency (EPA)-registered disinfectant.
• ORs are terminally cleaned daily.
• High-touch surfaces in patient care areas are cleaned and
disinfected with an EPA-registered disinfectant.
• The ambulatory surgical facility has a procedure in place to
decontaminate gross spills of blood.
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References
Centers for Disease Control and Prevention. Guideline for hand hygiene in
health-care settings: recommendations of the Healthcare Infection Control
Practices Advisory Committee and the HICPAC/SHEA/APIC/
IDSA Hand Hygiene Task Force [online]. MMWR Morbid Mortal Week Rep 2002
Oct 25 [cited 2011 Oct 26]. http://www.cdc.gov/mmwr/PDF/rr/rr5116.pdf.
Centers for Disease Control and Prevention, Healthcare Infection Control
Practices Advisory Committee. Guide to infection prevention for outpatient
settings: minimum expectations for safe care [online]. 2011 May [cited 2011
Oct 26]. http://www.cdc.gov/HAI/pdfs/guidelines/standatds-of-ambulatorycare-7-2011.pdf.
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References
Centers for Medicare and Medicaid Services. State Operations Manual (SOM)
appendix L, ambulatory surgical centers (ASC) comprehensive revision
[memorandum online]. 2009 May 15. [cited 2011 Oct 26].
https://www.cms.gov/SurveyCertificationGeninfo/downloads/SCLetter09_37.pd
f.
Dolan SA, Felizardo G, Barnes S, et al. APIC position paper: Safe injection,
infusion, and medication vial practices in health care [online]. Am J Infect
Control 2010 Apr [cited 2011 Oct 26].
http://www.apic.org/Resource_/TinyMceFileManager/Position_Statements/AJIC
_Safe_Injection0310.pdf.
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Additional Resources
Ambulatory Surgery Center Quality Collaboration. Sterilization audit checklist [online].
[cited 2011 Oct 26].
http://www.ascquality.org/Library/sterilizationhighleveldisinfectiontoolkit/Sterilization%20
Audit%20Checklist%20SPSmedical.pdf.
ASGE Quality Assurance in Endoscopy Committee, Petersen BT, Chennat J, et al.
Multisociety guideline on reprocessing flexible gastrointestinal endoscopes [online].
Gastrointest Endosc 2011 Jun [cited 2011 Oct 26].
http://www.asge.org/uploadedFiles/Publications_and_Products/Practice_Guidelines/Mult
isociety%20guideline%20on%20reprocessing%20flexible%20gastrointestinal.pdf.
Association for Professionals in Infection Control and Epidemiology. Instrument cleaning,
wrapping/packaging, and sterilization: competency [competency checklist online]. 2005
May [cited 2011 Oct 26].
http://www.ascquality.org/Library/sterilizationhighleveldisinfectiontoolkit/APIC%20Steriliz
ation%20Competency.doc.
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Additional Resources
Association for Professionals in Infection Control and Epidemiology, Greater
Omaha Chapter. Sterile processing checklist [online]. 2009 Jul [cited 2001 Oct
26]. http://www.goapic.org/documents/2009/SterileProcessingChecklist.pdf.
GOJO. Hand hygiene observation form [online]. [cited 2011 Oct 26].
http://www.gojo.com/~/media/GOJO/Countries/USA/Markets/Healthcare/AS
C/Files/Resources/HH%20observation%20form%20v2.doc.
GOJO. Sample environmental cleaning schedule—ambulatory surgery centers
[online]. [cited 2011 Oct 26].
http://www.gojo.com/~/media/GOJO/Countries/USA/Markets/Healthcare/AS
C/Files/Resources/sample%20environmental%20cleaning%20schedule.docx.
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Additional Resources
Lakeland Surgical and Diagnostic Center. Sample general area cleaning check list
[online]. [cited 2011 Oct 26].
http://www.beckersasc.com/accreditation/Sample%20General%20Area%20Cle
aning%20Checklist.doc.
Lakeland Surgical and Diagnostic Center. Sterile processing department testing
and load document [online]. [cited 2011 Oct 26].
http://www.beckersasc.com/accreditation/SPD%20Testing%20and%20Load%20
Document.doc.
Lakeland Surgical and Diagnostic Center. Sterile processing department testing
and QI load worksheet [online]. [cited 2011 Oct 26].
http://www.beckersasc.com/accreditation/SPD%20Testing%20and%20Load%20
QI%20Worksheet.xls.
Lakeland Surgical and Diagnostic Center. Terminal cleaning checklist [online].
[cited 2011 Oct 26].
http://www.beckersasc.com/accreditation/Sample%20Terminal%20Cleaning%2
0Checklist.doc.
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Questions and Answers
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