Transcription
Centers for Medicare andMedicaid ServicesAudit Tool Componentsfor Ambulatory SurgicalFacilities
Patient Safety in the Ambulatory Surgical Setting2
Hand Hygiene—Centers for Medicare andMedicaid Services (CMS) Requirements Staff to perform hand hygiene:––––3After removing glovesAfter direct patient contactBefore performing invasive proceduresAfter contact with blood, body fluids, orcontaminated surfaces (even if gloves are worn)
Hand Hygiene—CMS Requirements Hand hygiene supplies in patient careareas include the following:– Availability of sinks with soap, water, andpaper towels in all patient care areas– Installation and availability of alcohol-basedhandrub, according to Life Safety Code requirements4
HandwashingPolicyWhen hands are visibly dirty or contaminated with blood or otherbody 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 30seconds, 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.5
Hand Hygiene—Alcohol-Based Handrub If hands are not visibly soiled, use an alcohol-basedhandrub for routinely decontaminating hands in allclinical situations other than those listed under“Handwashing.” When decontaminating hands with an alcoholbased handrub, apply product to palm of one handand rub hands together, covering all surfaces ofhands and fingers until hands are dry.6
Hand Hygiene—Alcohol-Based Handrub Follow the manufacturer’s recommendationsregarding the volume of product to use. Alcohol-based handrubs are not sporicidal. Consider washing hands with soap and water ifcontact with spores (e.g., Clostridium difficile) islikely to have occurred. The physical action ofwashing and rinsing hands, if done appropriately,will likely remove spores from the surface of thehands.7
Hand Hygiene—Glove UsageCMS requires the following: Wear gloves for procedures that might involvecontact with blood and body fluids. Wear gloves when handling potentiallycontaminated equipment. Remove gloves when moving to the next task orpatient. Monitor hand hygiene by observing staff who aredirectly involved in patient care (e.g., physicians,nurses) (monitoring tool provided).8
Safe Injection Practices—CMS Requirements 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 ofdraw, initials of the person drawing, medication name,strength, and expiration date or time. Single-dose (single-use) medication vials are used for onlyone patient.9
Safe Injection Practices—CMS Requirements Manufactured prefilled syringes are used for only onepatient. Bags of intravenous solution are used for only one patient. Medication administration tubing and connectors are usedfor only one patient. Multidose injectable medications are used for only onepatient. The rubber septum on a multidose vial used for more thanone patient is disinfected with alcohol prior to each entry.10
Safe Injection Practices—CMS Requirements Multidose medications used for more than one patient aredated when they are first opened and discarded within 28days of opening or according to manufacturer’srecommendations, whichever comes first. Multidose medications used for more than one patient, arenot stored or accessed in the immediate areas where directpatient contact occurs. All sharps are disposed of in a puncture-resistant sharpscontainer. Sharps containers are replaced when the fill line is reached.11
Single-Use Devices, Sterilization, and HighLevel Disinfection—CMS Requirements Precleaning must always be performed prior tosterilization and high-level disinfection. Sterilization must be performed for criticalequipment (i.e., instruments and equipment thatenter normally sterile tissue or the vascularsystem, such as surgical instruments). High-level disinfection must be performed forsemicritical equipment (i.e., items that come intocontact with nonintact skin or mucousmembranes, such as reusable flexible endoscopesand laryngoscope blades).12
Single-Use Devices—CMS Requirements If single-use devices are reprocessed, they aredevices that are:– Approved by the U.S Food and DrugAdministration (FDA) for reprocessing– Reprocessed by an FDA-approvedreprocessor13
Sterilization—CMS Requirements Critical equipment is sterilized. Items are precleaned according to manufacturer’sinstructions or evidence-based guidelines prior tosterilization. Medical devices and instruments are visually inspected forresidual soil and recleaned as needed before packaging andsterilization. Method of sterilization is defined (e.g., steam autoclave,peracetic acid). A chemical indicator is placed in each load.14
Sterilization—CMS Requirements A biologic indicator is performed at least weekly and with allimplantable loads. Each load is monitored with mechanical indicators (e.g., time,temperature, pressure). Documentation for each piece of sterilization equipment ismaintained and up to date and includes results from eachload. Items are appropriately contained and handled during thesterilization process to ensure that sterility is notcompromised prior to use.15
Sterilization—CMS Requirements After sterilization, medical devices andinstruments are stored in a designatedclean area so that sterility is notcompromised. Sterile packages are inspected forintegrity, and compromised packages arereprocessed.16
High-Level Disinfection—CMS Requirements Semicritical equipment is high-level disinfected or sterilized. Method of high-level disinfection is specified, such asmanual, automated, or other processes. Items are precleaned according to manufacturer’sinstructions or evidence-based guidelines prior to high-leveldisinfection. Medical devices and instruments are visually inspected forresidual soil and recleaned as needed before high-leveldisinfection.17
High-Level Disinfection —CMS Requirements High-level disinfection equipment is maintainedaccording to manufacturer instructions. Chemicals used for high-level disinfection are:– Prepared according to manufacturer instructions– Tested for appropriate concentration according tomanufacturer’s instructions– Replaced according to manufacturer’s instructions– Documented to have been prepared and replacedaccording to manufacturer’s instructions18
High-Level Disinfection—CMS Requirements Instruments requiring high-level disinfection are:– Disinfected for the appropriate length of time as specifiedby manufacturer’s instructions or evidence-basedguidelines– Disinfected at the appropriate temperature as specifiedby manufacturer’s instructions or evidence-basedguidelines Items that undergo high-level disinfection are allowed to drybefore use. Following high-level disinfection, items are stored in adesignated clean area in a manner to prevent contamination.19
Point-of-Care Devices (e.g., blood glucose meter)—CMS Requirements A new single-use, auto-disabling lancingdevice is used for each patient. The glucose meter is not used on more thanone patient unless the manufacturer’sinstructions indicate this is permissible. The glucose meter is cleaned and disinfectedafter every use.20
Environmental Cleaning—CMS Requirements Observations are to be made of staff who performenvironmental cleaning (e.g., surgical technicians, cleaningstaff). Operating rooms (OR) are cleaned and disinfected after eachsurgical or invasive procedure with an EnvironmentalProtection Agency (EPA)-registered disinfectant. ORs are terminally cleaned daily. High-touch surfaces in patient care areas are cleaned anddisinfected with an EPA-registered disinfectant. The ambulatory surgical facility has a procedure in place todecontaminate gross spills of blood.21
ReferencesCenters for Disease Control and Prevention. Guideline for hand hygiene inhealth-care settings: recommendations of the Healthcare Infection ControlPractices Advisory Committee and the HICPAC/SHEA/APIC/IDSA Hand Hygiene Task Force [online]. MMWR Morbid Mortal Week Rep 2002Oct 25 [cited 2011 Oct 26]. http://www.cdc.gov/mmwr/PDF/rr/rr5116.pdf.Centers for Disease Control and Prevention, Healthcare Infection ControlPractices Advisory Committee. Guide to infection prevention for outpatientsettings: minimum expectations for safe care [online]. 2011 May [cited 2011Oct 26]. f-ambulatorycare-7-2011.pdf.22
ReferencesCenters 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 /downloads/SCLetter09 37.pdf.Dolan SA, Felizardo G, Barnes S, et al. APIC position paper: Safe injection,infusion, and medication vial practices in health care [online]. Am J InfectControl 2010 Apr [cited 2011 Oct 26].http://www.apic.org/Resource /TinyMceFileManager/Position Statements/AJICSafe Injection0310.pdf.23
Additional ResourcesAmbulatory Surgery Center Quality Collaboration. Sterilization audit checklist [online].[cited 2011 Oct t%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 n for Professionals in Infection Control and Epidemiology. Instrument cleaning,wrapping/packaging, and sterilization: competency [competency checklist online]. 2005May [cited 2011 Oct %20Competency.doc.24
Additional ResourcesAssociation for Professionals in Infection Control and Epidemiology, GreaterOmaha Chapter. Sterile processing checklist [online]. 2009 Jul [cited 2001 Oct26]. singChecklist.pdf.GOJO. Hand hygiene observation form [online]. [cited 2011 Oct 26].http://www.gojo.com/ JO. Sample environmental cleaning schedule—ambulatory surgery centers[online]. [cited 2011 Oct 26].http://www.gojo.com/ 0schedule.docx.25
Additional ResourcesLakeland Surgical and Diagnostic Center. Sample general area cleaning check list[online]. [cited 2011 Oct and Surgical and Diagnostic Center. Sterile processing department testingand load document [online]. [cited 2011 Oct Testing%20and%20Load%20Document.doc.Lakeland Surgical and Diagnostic Center. Sterile processing department testingand QI load worksheet [online]. [cited 2011 Oct Testing%20and%20Load%20QI%20Worksheet.xls.Lakeland Surgical and Diagnostic Center. Terminal cleaning checklist [online].[cited 2011 Oct %20Terminal%20Cleaning%20Checklist.doc.26
Questions and Answers27
Centers for Medicare and Medicaid Services Audit Tool Components for Ambulatory Surgical Facilities . Patient Safety in the Ambulatory Surgical Setting 2 . Hand Hygiene—Centers for Medicare and Medicaid Services (CMS) Requirements Staff to perform hand hygiene: –After removing gloves –After direct patient contact –Before performing invasive procedures –After contact with blood .
