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Loretta Litz Fauerbach, MS, CICFauerbach & Associates – Global Infection Prevention
ServicesMarch 7, 2013
Taking Quality to the Next LevelKentucky Hospital Association Annual Quality Conference
and Hospital Engagement Network Convening Louisville, Kentucky
Objectives
To identify the components in the Surgical Care Improvement Project
To discuss CMS SSI reporting requirements to NHSNTo clarify NHSN methodology To identify other quality initiatives related to SSI
prevention To identify key stake holders and reporting mechanisms
for a strong surgical site infection prevention program. To identify challenges with data collection and strategies
to improve communications related to identifying surgical site infections
To discuss accrediting and licensing requirements related to SSI prevention
LLF SSI Standards 2013
Impact of SSIs Occur in 2%-5% of patients undergoing inpatient surgery in the United States. Approximately 500,000 SSIs occur each year 7-10 additional post operative hospital days 2-11 times higher risk of death compared to
patients who do not have an SSI Patients with an SSI have a 2-11 times higher risk
ofdeath, compared with operative patients without an SSI.
77% of deaths in patients who have an SSI are directly attributable to SSI
Attributable costs vary depending on procedure and organisms but range from $3000 to $29,000
SSIs are believed to account for up to $10 billionannually in healthcare expenditures.
LLF SSI Standards 2013
SSI Burden of Illness Surgical Site Infections: Represent 20 percent of all health care-associated infections reported to the National Nosocomial Infections Surveillance System (NNIS) in 2002. Result in more than 8,000 deaths a year and occur in up to 25 percent of patients following major surgical procedures. Extend average length of stay by 9.7 days while increasing cost by $20,842 per admission. Are preventable in an estimated 40 to 60 percent of cases.
LLF SSI Standards 2013
•2.6% of 30 million operations complicated by SSI’s•SSI’s Second most common healthcare associated infection accounting for 17% of all hospital acquired infections• SSI’s most common healthcare associated infection in surgical patients (38%)•Consequences of SSI
•Increased hospital stay by up to 10 days• Increased hospital costs• Increased readmission rates• Increased pain and suffering CDC, 2003
LLF SSI Standards 2013
NPSG.07.05.01Implement best practices for
preventing surgical site infections.
• CDC Guideline for the Prevention of Surgical Site Infections
• SHEA Compendium• IHI Bundle Care
LLF SSI Standards 2013
• SSI 1• Deep incision and organ space infection rates using
NHSN definitions (SCIP procedures)
• Goal: CDC NHSN Median deep incision and organ space infection rate for each procedure/risk group will be at or below the current NHSN 25th percentile
• Measure: Surgical site infection rate: Deep wound and organ space infections as a result of elective surgery to include coronary artery bypass graft (CABG) and cardiac surgery; hip or knee arthroplasty; colon surgery; hysterectomy (abdominal and vaginal); and vascular surgery.
LLF SSI Standards 2013
SSI 2Adherence to SCIP/NQF infection process measures (perioperative antibiotics, hair removal, postoperative glucose control, normothermia) CMS SCIP
Goal: 95% adherence rates to each SCIP/NQF infection process measure.Cardiac surgery patients with controlled postoperative serum glucose; Surgery patients with appropriate hair removal; Prophylactic antibiotics received; Prophylactic antibiotics selection; Prophylactic antibiotics discontinued
Measure: Compliance with Centers for Medicare and Medicaid Services antimicrobial prophylaxis guidelines.
Evidence-Based Practice Guidelines for Surgical Site Infection Prevention
Four components of care include: 1. Appropriate use of prophylactic antibiotics Prophylactic antibiotic received within one hour prior to surgical incision Prophylactic antibiotic selection for surgical patients consistent with national guidelines Prophylactic antibiotics discontinued within 24 hours after surgery end time (48 hours for cardiac patients) 2. Appropriate hair removal (if deemed necessary, remove using clippers or depilatory)
Evidence-Based Practice Guidelines for Surgical Site Infection Prevention 3. Controlled postoperative serum glucose in
cardiac surgery • Glucose control is defined as serum glucose
levels below 200 mg/dl, collected at or closest to 6:00 a.m. on each of the first two postoperative days
• Tight glucose control (using an insulin drip) is often performed in an intensive care setting
4. Immediate postoperative normothermia in colorectal surgery
LLF SSI Standards 2013
Evidence-Based Practice Guidelines for Surgical Site Infection Prevention
Additional SCIP changes in care: • Beta blockade for patients on beta blockers prior to admission should be continued postoperatively • Venous thromboembolism prophylaxis • Ventilator-associated pneumonia prevention
Source: Institute for Healthcare Improvement, How-to Guide: Prevent Surgical Site Infections. (2012) http://www.ihi.org/explore/SSI/Pages/default.aspx Accessed 7/11/12.
LLF SSI Standards 2013
The Florida Surgical Care Initiative (FSCI)
A partnership between the Florida Hospital Association (FHA) and the American College of Surgeons (ACS), and endorsed by the Florida Chapter of the ACS, Focus initially on four outcome measures of the ACS National Surgical Quality Improvement Program (NSQIP)
LLF SSI Standards 2013
FSCI Surgical Outcome Measures
Standard ACS NSQIP* measures that are followed from pre-op to 30 days post-dischargesurgical site infection (SSI),urinary tract infection (UTI), colorectal outcomes and elderly surgery outcomes
LLF SSI Standards 2013
* ACS NSQIP - significantly decrease patient mortality and morbidity rates (Annals of Surgery, 250:363-376, September 2009)
LLF SSI Standards 2013
FSCI Unique Approach to Measurement
Uses medical chart data gathered by clinically trained personnel rather than insurance claims data derived from medical bills
Adjusts for risk so that the patient’s condition is taken into consideration when assessing the outcome
Evaluates how the patient is doing a month after his or her operation, since more than half of complications occur after discharge
Builds commitment and collaboration among surgeons, surgical teams and hospitals, because it is based on the highest quality data
LLF SSI Standards 2013
LLF SSI Standards 2013
Ambulatory Surgery Care Standards CMS State Operations Manual, Appendix L, Part I ASC Survey Protocol, and Part II General Conditions and Requirements http://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/downloads/som107ap_l_ambulatory.pdf May also be accessed through the AAAHC.org website
Very Similar to CMSCDC/SHEA/TJC recommendations for hospitals
LLF SSI Standards 2013
ASC416.51 Infection Control The ASC must maintain an infection
control program that seeks to minimize infections and communicable diseases
LLF SSI Standards 2013
ASC Key Elements of a Risk Assessment
Make it your own through a formal Risk Assessment
Collaborative effort Regularly reviewed and updated Governing body review Forms the basis for your written Infection
Prevention Plan including goals and measureable objectives
LLF SSI Standards 2013
Risk Assessment for Facility’sUnique Practice Setting
Identify Risks for Transmission
Populations Procedures – general and
specialty care procedures Geographic
Location/WeatherSize of Facility Referral PatternsOrganisms and risks
common to the community (endemic occurrences)
Surveillance data including HAIs and process monitoring
ConstructionCleaning, Disinfection
SterilizationSupply ChainStaffing
Medical ASC staff
LLF SSI Standards 2013
Types of Infections
Surgical Site InfectionsCA-UTIIntravenous Catheters including CLA-BSIsC. difficile or other GI pathogensRespiratory IllnessResistant Organisms
LLF SSI Standards 2013
Collaboration is Key Part of IP Risk Assessment
Interdisciplinary Input
Infection Prevention Team
Medical StaffNursing StaffAdministrationOther Leaders
Other potential participantsPatientsPublic RelationsPublic Health 3rd Party Payors
LLF SSI Standards 2013
Set Goals Based on Risk Assessment
High Risk - High VolumeLikelihood of event occurringKey Risks
Determine top prioritySet Goals
Establish measurements to evaluate goalsSet protocols for obtaining the data for the
measurements
LLF SSI Standards 2013
Infection Prevention Program and QA/PI Program Linkage
416.51(b) …”ongoing program designed to prevent, control, and investigate ..”
416.51(b)(2) …”an integral part of the ASC’s quality assessment and performance improvement program..”
LLF SSI Standards 2013
Basic Program Elements SSI Prevention
Hand Hygiene
Cleaning, Disinfection and Sterilization
Safe Injection PracticesLLF SSI Standards 2013
Qualified IP Required416.51 Condition for Coverage – Infection
Control: “The ASC’s infection control program must be directed by a designated health care professional with training in infection control.”
ICSW Item #17 – “Does the ASC have a licensed health care professional qualified through training in IC and designated to direct the ASC’s IC program?”
LLF SSI Standards 2013
Impact of ICSW Item #17:
“If the ASC cannot document it has designated a qualified professional with training in IC to direct its IC program, a deficiency must be cited.
Lack of a designated professional responsible for IC should be considered .. for a Condition level deficiency related to 416.51.”
LLF SSI Standards 2013
Common CitationsWritten materials are needed, yet are absent, incomplete, or insufficient to meet the standards
Cleaning, disinfection, and sterilization of instruments, equipment and supplies, environmental cleaning
Governing body formal meeting minutes
Policies & procedures Required recordkeeping
such as logs Evidence of delegation
of responsibilities Evidence of compliance
with policies
Manufacturer’s Recommendations
Follow AAMI, AORN, CDC
LLF SSI Standards 2013
Common Citations
Safe Injection Practices One Needle, One Syringe, One Patient, One Time
Outbreaks due to improper use of single dose vials, syringes and needles
Single patient use vials are single patient use, unless drawn up under a certified pharmacy hood, no exceptions!
LLF SSI Standards 2013
Nationally recognized guidelines adopted by your organization’s Governing Body as evidenced in formal meeting minutes Most current version Adherence Education Surveillance
Common CitationsProcedures to minimize risk of Infection including Surveillance
NHSN
CDC GuidelinesPatient Safety GoalsAORNProcess MonitoringOutcome MonitoringTargeted activities-
high risk /high volumeLegislative Mandates
DefinitionsMethodologyComparisons
LLF SSI Standards 2013
Tips for Success for Accreditation Survey
1. Present the most current standards book upfront.
2. Prepare for the challenging aspects3. Set up a space for the surveyor to work4. Document quality and infection prevention
initiatives5. Prepare a list of physicians and staff
a) Make sure credentials are in orderb) Have evaluations and education/orientation
records readily availableLLF SSI Standards 2013
Key Resources Accreditation Association for Ambulatory
Health Care [email protected] for general questions
Association for Professionals in Infection Control www.apic.org
Safe Injection Practices www.oneandonlycampaign.org
Center for Disease Controlwww.cdc.gov
LLF SSI Standards 2013
Basic practices for prevention and monitoring of SSI:
1. Perform surveillance for SSI (A-II).2. Provide ongoing feedback on SSI surveillance and process measures to surgical and perioperative personnel and leadership (A-II).3. Increase the efficiency of surveillance through the use of automated data (A-II).
LLF SSI Standards 2013 CDC SSI Guideline 1999
SSI Surveillance MethodsDaily Direct Observation by trained person starting
24-48 hours after surgery Considered to be the most accurate method of
surveillance, but rarely used due to resource limitation
Indirect SSI surveillance using a combination of sources Microbiology and Patient RecordsSurvey of surgeons and patientsRe-admission trackingOther information including coded dx, or op reportsEfficacy of Indirect Surveillance
Less time consuming, IP can perform during surveillance rounds
Reliable (sensitivity, 84%-89%) and specific (specificity, 99.8%) when compared to “gold standard” of direct surveillance.
LLF SSI Standards 2013 CDC SSI Guideline 1999
Automated SurveillanceExpanded by using hospital databases
data on administrative claims,days of antimicrobial use, readmission to the hospital,return to the operating room
Automatically import datamicrobiologic culture data, surgical procedure data, and general demographic information
Improve the sensitivity of indirect surveillance for detection of SSI
Improve IP efficiency in data collection
LLF SSI Standards 2013 CDC SSI Guideline 1999
Perform Surveillance
High Risk - High Volume Identify, collect, store, and analyze data
needed for the surveillance program.Implement a system for collecting data
needed to identify SSIs.Develop a database for storing, managing,
and accessing collected data on SSIs.Prepare periodic SSI reports (the time frame
will depend on hospital needs and volume of targeted procedures).
LLF SSI Standards 2013CDC SSI Guideline 1999
Perform Surveillance
Collect denominator data on all patients undergoing targeted procedures, to calculate SSI rates for each type of procedure
Identify trends (eg, in rates of SSI and pathogens causing SSIs).
Use CDC and NHSN definitions of SSIPerform indirect surveillance for targeted
procedures.Perform postoperative surveillance for 30
days; if prosthetic material is implanted during surgery then follow for 12 months
LLF SSI Standards 2013 CDC SSI Guideline 1999
Special Approaches for SSI PreventionPerform an SSI Risk Assessment
Perform Expanded SSI Surveillance
Identify areas that surveillance data suggest lack of effective control. Elements to Consider
High Risk -High Volume
Surveillance Data Rates Processes Organisms Strategies
Determine the source, extent of the problem, and to identify potential interventionsCase findingObservational
StudiesCheck adherence
rates to best practices
LLF SSI Standards 2013 CDC SSI Guideline 1999
Post Discharge SSI SurveillanceMore Procedures are being done in outpatient settingShorter Post OP stays for InpatientsNo standard method for Post OP SSI surveillance
o Questionnaires to patients, surgeons, or clinics o Shown to have poor sensitivity and specificity
Rates do increase after Post Op Surveillance implemented
Superficial incisional infections usually managed as outpatient
Deep incisional and organ/space infections typically require readmission to the hospital for management.
LLF SSI Standards 2013 CDC SSI Guideline 1999
LLF SSI Standards 2013
Infrastructure Requirements
Trained personnelInfection prevention and control personnel
SSI surveillance,Able to apply CDC definitions of SSI, Basic computer and mathematical skills,
and Good communication skills and adept at
providing feedback and education to healthcare personnel when appropriate
• NSQIP – surveillance nurse
LLF SSI Standards 2013 CDC SSI Guideline 1999
Computer Assisted Decision SupportCreating automatic reminders
Use computer support to improve pre-op administration of antimicrobial prophylaxisInitial and repeat dosesStop orders
Utilization of automated dataTracking Monitoring
LLF SSI Standards 2013
Feedback
Provide ongoing feedback on SSI surveillance and process measures to surgical and perioperative personnel and leadership (A-II).Routinely provide feedback on SSI rates and
process measures to individual surgeons and hospital leadership.For each type of procedure performed, provide
risk adjusted rates of SSI.Anonymously benchmark procedure-specific risk
adjusted rates of SSI among peer surgeons.Confidentially provide data to individual
surgeons,the surgical division, and/or department chiefs.
LLF SSI Standards 2013
Will automation and reminders help?
30% of SSI are preventable with
appropriate use of preoperative antibiotics*
LLF SSI Standards 2013 *Dellinger EP 2005
LLF SSI Standards 2013
•MD to treat any existing infection at remote site (urine, bloodstream, etc.)Remove hair only when necessary
»Do not shave»When necessary, use clippers or depilatories
• Control hyperglycemiaImplement preoperative showers--CHG preferred• Administer surgical prophylaxis according to guidelines• Maintain appropriate oxygenation control• Maintain normothermia/control of hypothermia
CDC SSI Guideline 1999
SSI Complexity
Microbial characteristics (eg, degree of contamination and virulence of pathogen)
Patient characteristics (eg, immune status and comorbid conditions)
Surgical characteristics (eg, type of procedure, introduction of foreign material, and amount of damage to tissues)
LLF SSI Standards 2013
Extrinsic Procedure Related Perioperative: Patient Preparation
Hair Removal Pre-Operative Infections
Do not remove hair unless hair will interfere with the operation
If hair removal is necessary remove by clipping.
Do not use razor. A I
Identify and treat remote infections prior to elective surgical procedures. A II
LLF SSI Standards 2013
CDC SSI Guideline 1999
LLF SSI Standards 2013
Do Not Remove Hair at the incision site, unless it will interfere with surgery itself.
If the hair must be removed, do it directly beforehand, preferably with electric clippers. (1A)
Pre-surgical patients should perform an antiseptic shower at least the night before and preferably also the morning of the scheduled surgery. Wash and clean the incision site area, scrubbing lightly to remove any gross skin contamination prior to antiseptic surgical preparation. (1B)
CDC, 1999
Hair Removal MethodShaving versus Clipping
Hair Removal Method Clean Wound Infection Rate (%)
Shaved with razor 2.5
Clipped 1.7
Electric razor 1.4
Not shaved, not clipped 0.9
Depilatories 0.6
LLF SSI Standards 2013
The increased risk with shaving prior to the operation is associated with microscopic cuts and shaving immediately before seriously reduces the SSI risk ( 20% risk if shaved > 24hrs--CDC, 1999).
Cruce and Forde, 1981
Implement evidence based standards (A-II)
Policies and practices should include but are not limited to the following:Reducing modifiable patient risk factorsOptimal cleaning and disinfection of equipment
and the environmentOptimal preparation and disinfection of the
operative site and the hands of the surgical team members
Adherence to hand hygieneTraffic control in operating rooms
LLF SSI Standards 2013 CDC SSI Guideline 1999
Intrinsic Patient Related - Perioperative
Un-Modifiable Modifiable
Un-modifiableAge
No formal recommendation: relationship to increased SSI due to comorbidities or immune status.
• Obesity Increase dosing pre-op antimicrobial
prophylaxis for morbidly obese patients.A-II
Smoking Cessation Encourage within 30 days before
procedure A-IIImmunosuppressive Meds
No formal recommendations Avoid if possible in perioperative period
if possible.C-II
• Glucose Control, diabetes Control serum glucose levels Reduce glycosylated hemoglobin A1c
levels to <7% before surgery, if possible
LLF SSI Standards 2013 CDC SSI Guideline 1999
Operative Characteristics
Surgical ScrubUse appropriate antiseptic agent to perform 2-5
minute preoperative surgical scrub or an alcohol-based surgical hand antiseptic product. A-II
Skin PreparationWash and clean skin around incision site; use an
appropriated antiseptic agent. A-II
LLF SSI Standards 2013 CDC SSI Guideline 1999
Operative Characteristics
Surgical skill/techniqueHandle tissue carefully and eradicate dead
space (A-III)
Antisepsis Adhere to standard principles of operating
room asepsis (A-III)
Operative TimeNo formal recommendation in most recent
guidelines; minimize as much as possible (A-III)
LLF SSI Standards 2013 CDC SSI Guideline 1999
Operative Characteristics - Operating Room Ventilation
Follow AIA recommendations (C-I)Traffic
Minimize operating room traffic (B-II)Environmental Surfaces
Use a US Environmental Protection Agency-approved hospital disinfectant to clean surfaces and equipment. (B-III)
Sterilization of surgical equipmentSterilize all surgical equipment according to
published guidelines (B-II)Minimize the use of flash sterilization
LLF SSI Standards 2013 CDC SSI Guideline 1999
Sterile GownsSelect Sterile gowns
When you will be at the sterile field When you are inserting a central line
Select based on level of potential blood exposureImperviousFluid Resistant
Twirl for closure and Tie securelyMaintain sterile area
Sides and back are not considered sterileDo not turn side or back to sterile field within 12
inches
LLF SSI Standards 2013 CDC SSI Guideline 1999
LLF SSI Standards 2013
Sterile above the table
Side, back and below table areas are non-sterile
Shaded portion indicates protective
barrier zones
LLF SSI Standards 2013
Sterile during
procedure
Protective Barrier
Not part of sterile field when below
table
Gowns for Non-scrubbed Personnel
Select gown for blood borne pathogen protection requirementsHow likely are you to be splattered during a procedure?
How likely are you to contaminate yourself with potentially infectious material
Is the patient on isolation precautions?
LLF SSI Standards 2013
Lead ApronsEstablish cleaning procedure
After useInspect prior to procedure to make sure
they are clean and ready to goHang and store to prevent
contamination by splashing
LLF SSI Standards 2013
General Infection Control for Non-scrubbed Participants
Hand Hygiene Prior to entry of OR After touching patient or patient’s equipmentDuring procedure as appropriate
Wear gloves if likely to be contaminated with blood or body fluids
Wear mask appropriately
LLF SSI Standards 2013
Alcohol gel : Place on cart or desk for easy access and use
Perform hand hygiene and don clean gloves before and after handling patient devices IV, Foley, etc
Perform hand hygiene before and after positioning patient
LLF SSI Standards 2013
Hand Hygiene Plus Changing Gloves Hand Hygiene Plus Changing Gloves is critical for infection preventionis critical for infection prevention
General Infection Prevention for Non-scrubbed Participants
Use appropriate technique to enter vialsClean top with alcohol - do not just pop or
access without cleaningMaintain distance from sterile field
Non-sterile participants must maintain at least a 12” distance from sterile field
Minimize talking Minimize moving around in roomMaintain all precautions until surgery is
completed and surgical site is closed
LLF SSI Standards 2013
LLF SSI Standards 2013
P
a
t
i
e
n
t
Sterile field tables•Set up so there is 1’ clearance for staff to work between tables
•Do not turn back to sterile field within 1’
•All non-scrubbed staff must maintain distance
Maintain sterility of equipment cover
•Do not turn back to equipment
Below table tops are not sterile - do not bend down or turn to side
Anesthesia Cart
•Make sure tables are clean before starting to set up the room•Set up using sterile technique•Evaluate the amount of items that are opened and on sterile table
OR Traffic Flow
Personnel must enter by sub-sterile room Enter by larger corridor door only when
Bringing patient into room Bringing large equipment into room
Do not enter by larger doors during procedure May enter if a piece of equipment is absolutely
necessary for case Keep doors to corridor closed at all times
except for above situations (1&2)
LLF SSI Standards 2013
Equipment & Product Reps
Educate and require sign in prior to coming to ORAll reps must
complete mandatory Infection Control Education
Wear hospital provided scrubs
Perform hand hygiene prior to entry and as appropriate during case
Don and wear mask appropriately
If going to be near sterile field to assist in equipment utilization, representative should:Wear sterile attireScrub inUse laser pointer
Consider wearing long sleeve jacket or gown to decrease shedding
Limit the number of observers to those who are essential to the case
Limit movement and talking in OR suite during procedure
LLF SSI Standards 2013
Handling of Equipment from Outside Company
Must be cleaned, inspected and sterilized by OR staff Staff should use appropriate lighting and
magnification to inspect smaller piecesOR techs must inspect for cleanliness and residual
debris after re-stocking by representative prior to sterilization
Equipment must be brought to OR the day before surgery to assure appropriate handling
No routine flash sterilization of company equipment
LLF SSI Standards 2013
Set up fluid basins using sterile techniqueLabel all fluid basins with content and doseChange all fluids every 4 hours for longer
proceduresUse single use products /Single Patient
Product vials must be maintained until the end of surgery as a patient safety measure
Discard at end of caseWhen in doubt - throw it out!
Discard fluid from basin if any potential for contamination occurs
LLF SSI Standards 2013
Safe Management of Fluids
Maintain sterile fields and practices until site is completely closed
Do not start to break down tables and remove hoses, etc while suturing is being done
LLF SSI Standards 2013
Operating Room - Patient Advocacy
Maintain watchful eye for any break in sterile technique
Empower everyone to point out breachesCirculator should actively assist in observing
practice and recognizing breaches Simulation of incidences will improve response
during surgeryEveryone is responsible for the patient’s safety!
LLF SSI Standards 2013
Immediate-Use Steam Sterilization (IUSS)
Shortest possible time between a sterilized item’s removal from the sterilizer and its aseptic transfer to the sterile fieldProtect during transfer from contaminationUse containers for transport-AORN
recommendation Survey Readiness for Cleaning, Disinfection & Sterilization
Do not store for future useDo not hold from one case to another
LLF SSI Standards 2013
IUSS Recommendations, cont.
Follow same cleaning, decontamination and transport step as other processingCleaning agents and brushesPPEsWater qualityFollow manufacturer’s recommendationsMonitor sterilization process including
biological, chemical and others
LLF SSI Standards 2013
IUSS Recommendations, cont
Implants must not be process by IUSS except in a documented emergency situation and no other option is available
Only process devices and loads that have been validated with the specific cycle employed
IUSS is not to be a substitute for adequate inventory
LLF SSI Standards 2013
Survey Readiness for Cleaning, Disinfection &
Sterilization
LLF SSI Standards 2013
Focus on Cleaning PracticesManufacturer’s Instructions for Use (IFU)
Up to date oneSource document site
(www.onesourcedocs.com or 1-800=701-3560)Available and used
Staff competency for cleaning and decontamination based on IFUsAttention to detail for cleaning and rinsingCleaning implements such as brushes, clothes, etc
Discard or Re-use: be sure staff knows exactly how a brush should be handled
Documentation of Training and Competency
LLF SSI Standards 2013
Standardized Processes
Instruments cleaned and processed the same regardless of area (i.e. OR, CSS, etc)
Loaner and other instruments handled identicallyTake apart rigid containers for cleaning
NO SHORT CUTS
LLF SSI Standards 2013
Sterilizer Biological MonitoringAAMI ST79
Test at least weekly, once a day betterTest all types of loads
Rigid containersProtective caseSurgical wrap Hint- since each configuration must be tested
it is wise to limit the number of configurations Temperature/PressureGravity and Dynamic Air Removal
LLF SSI Standards 2013
Implants
Test all cycles with implant BI, Class 5 Integrator
Do not release until biological result is availablePolicy for early release
Multidisciplinary Input Who can determine it?
Surgeon OR Administration Define emergency exceptions
Traceability of Implants
LLF SSI Standards 2013
IUSS Monitoring
Place BI on bottom shelf over drainUse a Class 5 indicator as an internal chemical
indicatorPhysical Monitors
Document - who started and then who removed item from sterilizer
Reconcile with patient informationReview all data by experienced personDo not use if any data suggests a failure
LLF SSI Standards 2013
Loaner Policy
Know Contents and Manufacturer’s IFUDetailed inventory of contentsFDA clearance
Adequate time for cleaning, decontamination and sterilization prior to procedure
Maintain records Identify responsibility of surgeon, OR staff,
sterile processing area and sales repLoaner Checklist Communication is Key
LLF SSI Standards 2013
CMS Mandatory Reporting for Surgical Cases 2012
Centers for Medicare and Medicaid Inpatient Prospective Payment System
Hospitals must report SSI surveillance data for COLO and HYST via NHSN to avoid a reduction of 2.0 percent in their Medicare Annual Payment Update
LLF SSI Standards 2013
In PatientNHSN Operative Procedure Categories
COLO: Incision, resection or anastamosis of the large intestine; includes large-to-small and small-to-large bowel anastamosis; excludes rectal repairs*
HYST: Removal of uterus through the abdomen* (includes laparoscopic)
* General descriptions only; follow ICD-9-CM list
LLF SSI Standards 2013
SSI Requirements
Facilities must observe NHSN SSI protocol in entirety
NHSN will submit a subset of data to CMS: – >18 years of age – Inpatients – Deep incisional and/or organ/space SSI – Identified on admission or readmission
LLF SSI Standards 2013
LLF SSI Standards 2013
http://www.cdc.gov/nhsn/index.html
http://www.cdc.gov/nhsn/PDFs/pscManual/9pscSSIcurrent.pdf
http://www.cdc.gov/nhsn/library.html
http://www.cdc.gov/nhsn/PDFs/pscManual/14pscForm_Instructions_current.pdf
Tenets of Surveillance
Surveillance versus Clinical Definitions Different purposes
– May not agree –Comments section useful to note important factors
Can submit questions to NHSN mailbox [email protected]
LLF SSI Standards 2013
Tenets of Surveillance
Consistency is a Must! Criteria designed to look at a population
at risk Identify patients meeting the criteria Consistently apply the criteria Ensures the comparability of the data-
protects your facility and others
LLF SSI Standards 2013
NHSN Requirements for Surveillance Active Patient-based not culture-based ProspectiveRequires that a variety of sources for case
finding be utilized: Culture results Nursing unit rounds; kardexes, wound care
and ID consults, temperature logs, etc. Staff notification Readmissions
LLF SSI Standards 2013
Definitions
SSISuperficial Incisional SSI (primary or
secondary)Deep Incisional SSIOrgan/Space SSI
ORImplantsEmergencyEndoscope
LLF SSI Standards 2013
SSI DefinitionsCDC/NNIS/NHSNTypes
Superficial incisional (involving only skin or subcutaneous tissue of the incision)
Deep incisional (involving fascia and/or muscular layers)
Organ/space
LLF SSI Standards 2013
NHSN Risk Factors
Patient Risk Factors Hospital Factor LevelGeneral anesthesiaAge Wound class Emergency Gender ASA score Trauma Endoscope Duration of procedure
Bed sizeMed School Affiliation
LLF SSI Standards 2013
LLF SSI Standards 2013
Standard Infection Ratio (SIR)
Based on Standardized Mortality Ratio (SMR) Used extensively in public health research Compares the experience in one facility to that in a
standard population Advantage: Presents in single metric how the
number of infections experienced relates to the expected number
Number Observed/Number Expected
LLF SSI Standards 2013
COMPUTING THE SIR
Numerator: Simply the number of infections at that facility during time period
Denominator: Multiply the referent stratum-specific rates by the number of patients in each stratum Sum all of these Equals the “expected denominator”
LLF SSI Standards 2013
What does a SIR mean?
An SIR of “1” signifies that the observed and expected numbers of HAI are the same when compared to like locations in NHSN
An SIR of > “1” signifies that there were more
observed HAIs CAUTIs than expected when compared to like locations in NHSN. i.e., SIR= 1.50 = 50% more Infections
An SIR of < “1” signifies that there were fewer observed HAIs than expected when compared to like locations in NHSN. i,e, SIR=0.50 = 50% fewer infections
LLF SSI Standards 2013
Accurate Denominator Data Is Critical
Surgery completed in a single trip to the OR Incision closed before leaving OR Surgery conducted in defined operating
room suite May be an in- or out-patient procedure
(based on monthly reporting plan) Laparoscopic & traditional approaches
included
LLF SSI Standards 2013
Operative CharacteristicsSCIP Antimicrobial prophylaxis
Administer antimicrobial prophylaxis only when indicated A-I
Timing o Administer within 1 hour before incision to maximize tissue
concentration A-Io Vancomycin and fluoroquinolones can be given 2 hours before
incision. Choice
o Select appropriate agent on basis of surgical procedure, most common pathogens causing SSI for a procedure, and published recommendations. A-I
Duration of Therapyo Stop prophylaxis within 24 hours after the procedure for all
procedures, except cardiac surgery; for cardiac surgery, antimicrobial prophylaxis should be stopped within 48 hours. A-I
LLF SSI Standards 2013
Do not use these strategies routinely to prevent SSIs
1. Do not routinely use vancomycin for antimicrobial prophylaxis;
a) vancomycin can, however, be an appropriate agent for specific clinical circumstances (B-II).
b) Reason for use must be documentedc) Does not cover gram negative bacteria
2. Do not routinely delay surgery to provide parenteral nutrition (A-I).
LLF SSI Standards 2013
SSI Prevention Measures4. Measure and provide feedback to providers on therates of compliance with process measures, includingantimicrobial prophylaxis, proper hair removal, and
glucosecontrol (for cardiac surgery) (A-III).
5. Implement policies and practices aimed at reducingthe risk of SSI that meet regulatory and accreditationrequirements and that are aligned with evidence-basedstandards (eg, Centers for Disease Control and
Preventionand professional organization guidelines) (A-II).
LLF SSI Standards 2013
SSI Prevention EducationEducate surgeons and perioperative
personnel about SSI prevention (A-III). Teach strategies aimed at minimizing
perioperative SSI risk through implementation of recommended process measures.
Provide education regarding the outcomes associated with SSI, risks for SSI, and methods to reduce risk to all patients, patients’ families, surgeons, and perioperative personnel.
Local epidemiology including MDROs includingMRSA
Basic prevention strategiesLLF SSI Standards 2013
SSI Prevention EducationEducate patients and their families about SSI
prevention, as appropriate (A-III). Provide instructions and information to
patients before surgery, describing strategies for reducing SSI risk.
Specifically provide preprinted materials to patients in accordance with evidence-based standards and guidelines
LLF SSI Standards 2013
LLF SSI Standards 2013
Points Discussed / Questions asked in Handout:-Will I receive and antibiotic prior to surgery?-Should I take a shower with antibacterial soap prior to surgery?
Infection Control Tips:-Keep your hands clean-Do not hesitate to ask your healthcare provider if he/she has washed their hands-Cover your mouth and nose when you cough or sneeze. Discard
the tissue and then clean your hands-Safely care for wounds and catheters by learning proper aseptic or clean techniques-Handle needles and other sharp items safely and discard into a sharps container to prevent injury to you and others
LLF SSI Standards 2013
Patient Education
Web Pages and Materials for PatientsJAMA patient page: wound infections (from the
Journal of the American Medical Association; available at:http://jama.ama-assn.org/cgi/reprint/294/16/2122)
Surgical Care Improvement Project consumer info sheet (available at: http://www.ofmq.com/Websites/ofmq/Images/FINALconsumer_tips2.pdf)
What you need to know about infections after surgery: a fact sheet for patients and their family members (available at: http://www.ihi.org/NR/rdonlyres/0EE409F4-2F6A-4B55-AB01-16B6D6935EC5/0/SurgicalSiteInfectionsPtsandFam.pdf)
LLF SSI Standards 2013
IHI SSI Prevention Bundle
Appropriate use of antibioticsAppropriate hair removalMaintenance of post operative glucose for major cardiac surgical patients
Post operative normothermia for colorectal surgery patients
LLF SSI Standards 2013
Checklists in OR Improve Performance
When checklists were available to surgical teams, they missed just 6 percent of life saving steps, compared with 23 percent when the tool was not available, according to results published online Wednesday in the New England Journal of Medicine.
January 2013
LLF SSI Standards 2013
LLF SSI Standards 2013
LLF SSI Standards 2013
LLF SSI Standards 2013
LLF SSI Standards 2013
LLF SSI Standards 2013
LLF SSI Standards 2013
Current Issues Preoperative bathing with chlorhexidine-
containing productsNot conclusiveOther processes in study
Impregnated wipes Regular or foam CHG direct application Routine bed bath with CHG
To gain the maximum antiseptic effect of chlorhexidine, it must be allowed to dry completely and not be washed off.
Studies do show reduction in skin flora and some also correlate now to reduction in SSI
Patient ComplianceDid they do it?Did they reach critical areas?
LLF SSI Standards 2013
Current Issues Routine screening for MRSA or routine attempts to
decolonize surgical patients with an anti-staphylococcal agent in the preoperative settingTimingOpportunity
Mupirocin in specific patient groups undergoing orthopedic or cardiac surgery may be effective Not randomized controlled trials.
Preoperative intranasal and pharyngeal chlorhexidine treatment for patients undergoing cardiothoracic proceduresAlthough data exist from a randomized, controlled trial to
support its usage, chlorhexidine nasal cream is neither approved by the US Food and Drug Administration nor commercially available in the United States.
LLF SSI Standards 2013
Do the new Antimicrobial Products reduce SSIs?
Product Types Future NeedsSutures
Dressings
Skin Preps or CleansersWipesOther forms
Intra operative Irrigation Products
Industry sponsored
Multi-center trials needed
Independent studies with enough cases
Value Analysis
LLF SSI Standards 2013
LLF SSI Standards 2013
Packet given in the clinics or during preop testing -Instruction sheet-Patient Safety Handout-Packet or container with CHG product
Other areas for pre-operative showering:-Pre-op Admissions or Pre-Op Holding Area-Pre-admission on a floor or ICU
Documentation of pre-operative showering:-Pre-op nursing notes in holding area-Clinic notes-Transplant coordinator notes-Unit nurse who assisted with bath
LLF SSI Standards 2013
•Preoperative shower or bath with CHG reduces skin microbial counts more effectively than povidone-iodine or other antimicrobial soaps
• Bathing 2 times with CHG (once the evening before & then the morning of ) is recommended to increase effectiveness.
• New IHI Ortho recommends showering x3 days
• Daily bathing with CHG has been shown to reduceCatheter Line Associated Bacteremias, MRSA, and C. difficile.
LLF SSI Standards 2013
Pre-Operative Showering & No Shaving
for the Prevention of Surgical Site InfectionsTips for SSI Prevention:• Showering with CHG soap both the night before and morning surgery• Shaving is no longer recommended unless ordered specifically by the physician
Why Pre-op Shower, you ask? To reduce normal skin flora at the surgical site and minimize the risk of developing infections. Also, by not shaving any areas, you keep the skin intact and reduce micro tears that could become sources of infection.
What do I tell the patient to do:• Shower both the night before and the morning of the surgery• Use the CHG soap provided at time of the clinic visit• Do not shave any areas of the body within 48 hours prior to surgery• Scrub body from head to toe avoiding mucous membranes, eyes, ears, etc.• Dry off with clean dry towel
What do I Give to the Patient:• Written instructions and information sheet•CHG soap (approximately 30 ccs)
How do I document this information:• Please note in the progress / clinic note that info and product was given• If in Pre-Op area, please note on peri-operative form if pt showered in pm and am
Questions:
Please call Infection Control
Thank you for your participation in this initiative to reduce Surgical Site Infections.
LLF SSI Standards 2013
Preoperative Chlorhexidine Bathing InstructionsOnce the decision to have surgery has been made, there are a few steps you can take to reduce your
risk of acquiring an infection at the surgical site. Your skin is not sterile and contains germs that are present everyday. We are able to live with these germs because of our skin barrier. Once the barrier is broken, for example, with a surgical incision, you become more vulnerable to these germs. In an effort to protect yourself from these germs, a preoperative shower with a special soap is recommended. This soap contains a substance called chlorhexidine gluconate (CHG)* and helps to reduce the numbers of bacteria on your skin. This soap will be given to you or it may be purchased at a local drug store. (Call ahead and ask if it is in stock).
*Not to be used by people with known allergies to chlorhexidine. If an allergic reaction occurs, call you doctor immediately.
Soap is for topical use only; DO NOT DRINKBathing Instructions:1)Shower or bathe with CHG both the night before and the morning of your surgery. Do NOT shave
any body area.2)Wash your hair in the usual fashion with your own shampoo and rinse your hair and body thoroughly.3)From the neck down, apply the CHG to your entire body paying close attention to the area where
your surgery will be performed. (DO NOT put the CHG near your face, eyes, or ears as it can cause permanent damage).
4)Turn the water off to prevent rinsing prematurely and continue to lather and wash your body for 5 minutes. Do NOT scrub your skin too hard as you wash and do not wash your body with regular soap after the CHG.5)Turn the water back on and rinse thoroughly, then pat yourself dry with a clean, fresh towel.
Pay particular attention to the circled areas
SCIP INFECTION MEASURESSCIP Inf-1 - Prophylactic Antibiotic Received Within One Hour Prior to Surgical Incision SCIP Inf-2 - Prophylactic Antibiotic Selection for Surgical Patients SCIP Inf-3 - Prophylactic Antibiotics Discontinued Within 24 Hours After Surgery End Time SCIP Inf-4 - Cardiac Surgery Patients With Controlled 6 A.M. Postoperative Blood Glucose SCIP Inf-6 - Surgery Patients with Appropriate Hair Removal SCIP Inf-9 - Urinary catheter removed on Postoperative Day 1 (POD 1) or Postoperative Day 2 (POD 2) with day of surgery being day zero SCIP Inf-10 - Surgery Patients with Perioperative Temperature Management
LLF SSI Standards 2013
LLF SSI Standards 2013
Improvement StrategiesIncorporated into OR ChecklistLetters to team members with timing failuresReview by SCIP committeeEmail to all noting how many days since
failure by OR locationCulture Change – self reporting of failuresAntimicrobial Team – Selection education and
interventions
LLF SSI Standards 2013
Infection Prevention CommunicationWhere
Each Surgical Service Patient Care Units for
CA-UTI prevention C-Suite Infection Prevention &
Control Committee Service/Unit
Departmental Meetings Quality Safety
Evaluation Committee SCIP Team Board Quality
When QuarterlyDaily for CA-UTIOther
WhatQuarterly Service
Specific SSI Rate Trending + Recommendations
CA-UTI Prevention by Units
LLF SSI Standards 2013
LLF SSI Standards 2013
Strategies of the Neurosurgery Infection Prevention Team
Employed Adverse Event Trigger Strategy Every Monday IPC notified NSG Chair of potential cases Investigation and Data Collection related to procedure and team
members NSG Team reported infections to IP Each case reviewed with all participants at meeting 2x’s a month Root Cause Analysis discussion concerning each case was done Evaluation of Practice, including surgical and unit procedures and
OR setting OR observational studies performed by IP with feedback to team
and staff Education – every meeting addressed a “hot topic” Development of Checklist
LLF SSI Standards 2013
Surveillance & Data Trending• SSIs detected through reporting of infections
from the NSG Team as well as by routine surveillance methodology used by the IPC Department.
• Class I SSI and procedure-specific SSI rates were calculated on a quarterly basis.
• Reported to IPC Committee, NSG team, Surgical Committee and Operations Committee of the Medical Staff and through the quality committee structure.
LLF SSI Standards 2013
LLF SSI Standards 2013
Risk Factors Analyzed for Class 1 NSG SSI
Name
Medical Record Number
Admission Date
Discharge Date
Diagnosis
Attending Physician
Resident Physician
Operation Performed
OR Date
Time of Surgery
Post-operative Unit
Culture Date
Organism
Source of Culture
# of Days from OR to Culture Date
Location Prior to OR
OR Room Number
OR Personnel
Choice of Pre-operative Antibiotics
Timing of Pre-operative Antibiotics
Dosage of Pre-operative Antibiotics
ASA Score
Patient’s Sex
Patient’s Age
Patient’s Race
Hair Removal
Body Mass Index
Re-dosing of Antibiotics
Risk Index
Re-admissions
Process & Practice Improvements• Improved classification with implementation of a mandatory
classification field• Developed & implemented checklist and improved
consistency in following recommended practices• MRSA screening has identified about 8% of their elective
surgical patients are MRSA positive. Noted that more patients had infections with MSSA• NSG staff screened for MRSA/MSSA- no MRSA isolated,
4 MSSA identified and decolonized. No linkage to cases.• Implemented pre-op screening for MRSA/MSSA and
decolonization
LLF SSI Standards 2013
Process & Practice Improvements• Improved consistency of Pre-op Showering with CHG • Improved Management of medications, vials and fluids
• Created signage to make sure vial tops were scrubbed with alcohol before each entry
• Improving OR environment (new carts, more storage, on-going monitoring by 2 OR patient safety nurses, no personal items in the OR room)
• NSG to report infections to IP
LLF SSI Standards 2013
Process & Practice Improvements• Education for Anesthesiology, OR team and Patient Care
Unit staff
• Pre-Op Antibiotics (ABX) Prophylaxis• Changed ABX prophylaxis to Kefzol from
Vancomycin based on literature review, if Vancomycin is used Kefzol is still needed, unless allergic
• DC ABX at 24 hours according to SCIP
LLF SSI Standards 2013
References CDC Prevention of Surgical Site Infections, 1999 http://www.cdc.gov/ncidod/dhqp/pdf/guidelines/SSI.pdf Altemeir WA, Burke JF, Pruitt, BA, Sandusky,WR and the American College of
Surgeons, Committee on Control of Surgical Infections of the Committee on Pre-and Postoperative Care. Manual on Control of Infection in Surgical Patients.Second Edition. JB Lippincott Company. Philadelphia. 1984.
Janelle J, Howard, RJ, and Fry D. Chapter 23 Surgical Site Infections. APIC Text of Infection Control and Epidemiology, 2nd Edition, 2005.
Mangram AJ, Horan TC, Person ML, Silver LC, Jarvis WR. The Hospital Infection Control Practices Advisory Committee. Guideline for prevention of surgical site infection. Infection Control and Hospital Epidemiology 1999;20:247-280.
LeFrock, SHEA Annual Meeting, Philadelphia, 2004. Bratzler, DW. Surgical Infection Prevention and Surgical Care Improvement:
National Initiatives to Improve Care for Medicare Patients. http://www.medqic.org/dcs/
Yokoe DS, Mermel LA, Anderson DJ, Arias KM, Burstin H, et. al.Compendium of Strategies to prevent HAIS. Infection Control and Hospital Epidemiology October 2008, Vol. 29, supplement 1www.shea-online.org
World Health Organization www.who.org IHI www.ihi.org Surgical Site Infection (SSI) Reporting Through NHSN: Tips, Trips and
Best Practices . Kathy Allen-Bridson. Nurse Consultant , Division of Healthcare Quality Promotion, Centers for Disease Control and Prevention , November, 2011, Webinar
LLF SSI Standards 2013
Resources1. Klevens R.M., Edwards JR, Richards CL Jr., et al. (2007) Estimating health care-associated infections and deaths in U.S. hospitals, 2002. Public Health Rep. 2007;122(2):160-166. 2. de Lissovoy G, Fraeman K, Hutchins V, et al. (2009) Surgical site infection: incidence and impact on hospital utilization and treatment costs. Am J Infect Control. 2009;37(5):387-397. 3. Five Million Lives Campaign. (2008) Getting Started Kit: Prevent Surgical Site Infections How-to Guide. Cambridge, MA: Institute for Healthcare Improvement; 2
LLF SSI Standards 2013
ReferencesAAMI http://www.aami.org/publications/standards/ST79 http://www/aami.org/pubications/standards/ST79_Immediate Use Statem
ent.pdf
AORN Perioperative Standards and Recommended Practices Recommended Practices for Sterilization in Perioperative Setting Recommended Practices for Cleaning and Care of Surgical Instruments
and Powered Equipment Recommended Practices for Surgical Attire
Centers for Medicare & Medicaid Services Ambulatory Surgical Center Survey
LLF SSI Standards 2013
LLF SSI Standards 2013