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Transcript
Accreditation & Regulatory
Requirements for the Infection
Prevention & Control Program
Acute & Ambulatory Care Settings
Russ Olmsted, MPH, CIC
[email protected]
Objectives





Describe impact of value-based purchasing on
awareness and focus on prevention of HAIs
Describe at least one element of performance related
to infection prevention accreditation requirements
List at least one national patient safety goal that relates
to infection prevention
List at least one condition from CMS that applies to
hospitals and ambulatory surgery centers
Describe application of accreditation and regulatory
requirements to healthcare facilities
Platform for Performance Improvement
The Vision of Health Care in the U.S.
2012 • Fragmented
• Fee-for-service
Volumedriven
healthcare
Cost
VALUEdriven
healthcare
Quality
• Connected
• Bundled
• Accountable
Value Based PurchasingDefinition
As part of the Affordable Care Act, congress
has authorized the inpatient Value Based
Purchasing Program, which provides a data
reporting infrastructure for hospitals to help
ensure quality patient outcomes
http://www.cms.gov/Medicare/Quality‐Initiatives‐Patient‐Assessment‐Instruments/
hospital‐value‐based‐purchasing/index.html?redirect=/hospital‐value‐based‐purchasing
Accessed on April 26, 2013
Crossing the Chasm: New Era of
Accountability & Value-Based Care
No facility is an
“island”
Acute
Care
Facility
Home
Care
Outpatient/
Ambulatory
Facility
Tranquil Gardens
Nursing Home
Long Term Care
Facility
Making The Case for Jumping the
Chasm: the portable patient!
Interfacility sharing of patients, Orange County, California, 2005
Each hospital = unique color ; 29% of patients had > 2 admissions
Of those with > 2 adms. 75% transferred between facilities
Huang SS et al. Infect Cont Hosp Epidemiol 2010
The Portable Patient, continued. .
3 different
phases of
investigation of
inter-facility
trans. of
carbapenemprod. K.
pneumoniae
24 (60%) of 40
cases were
linked to
LTACH-A
Won S Y et al. Clin Infect Dis. 2011;53:532-540
The Portable Patient, continued
Microbial Highways:
Networks of interfacility transmission
of carbapenemaseprod. K. pneumoniae
4 adjacent counties, IN
& IL
40 patients (11 [27.5%]
Fatal infection)
24/60 (60%) cases
assoc. with LTAC “A”
Won SY, et al. Clin Infect Dis
2011
Cluster reached 14
Hosp., 2 LTAC, & 10
LTCFs.
Case Study: George & C. difficile
1) Visits his primary care provider;
receives Rx for antibiotic for LRI
2) Falls @ home and breaks his leg,
admitted to “hospital A” acquires
C. difficile
3) Transferred to inpatient rehab
facility in hosp. A; develops acute,
watery diarrhea + WBC incr +
fever
4) Transferred back to progressive
care unit in hospital A Rx. - oral
vanco.
6) Too weak to return
home….admitted to LTCF B
CDC. Vital signs 2012: CDI
External Drivers: Rise
of Consumer Driven
Legislation
Action Plan to Prevent HAIs, June 2009
http://www.hhs.gov/ash/initiatives/hai/index.html
Tier 1: Targets/Metrics – Acute Care
Tier 2: Ambulatory Surgery Clinics, Dialysis Centers,
Influenza vaccine for Healthcare Personnel
Tier 3: Long Term Care
American Recovery and
Reinvestment Act (ARRA), 2009.
Public Law 111-5
Wright D. HHS Roadmap to Elimination of HAIs
http://www.hhs.gov/ash/initiatives/hai/actionplan/index.html
Federal HAI Reporting To NHSN Under Inpt.
Quality Reporting: Past/present & Future
2011
• CLABSI – Acute Care ICUs (Jan.)
2012
•
•
•
•
•
CAUTI – Acute Care ICUs (except NICUs) (Jan.)
CAUTI – LTCH, IRF, Cancer Hospitals (Oct)
SSI – Colon Surgeries and Abdominal Hyst. – Acute Care (Jan)
Dialysis Events – ESRD (Jan)
CLABSI – LTCH, Cancer Hospitals (Oct)
2013
•
•
•
•
C. Diff LabID Events – Acute Care (Jan.)
MRSA Bacteremia LabID Events – Acute Care (Jan.)
HCP Influenza Vaccination – Acute Care (Jan.)
HCP Influenza Vaccination – LTCH (Jan.)
2014
• HCP Influenza Vaccination – ASCs (Oct.)
• SSI – Cancer Hospitals (Jan.)
• HCP Influenza Vaccination – IRF (Oct.)
2015
•
•
•
•
CLABSI – Acute Care Med, Surg, Med/Surg Units (Jan.)
CAUTI – Acute Care Med, Surg, Med/Surg Units (Jan.)
MRSA Bacteremia LabID Events – LTCH (Jan.)
C. Diff LabID Events – LTCH (Jan.)
APIC. Federal HAI Reporting to NHSN resource update. www.apic.org 9/17/13
The Future of VBP
Domains
http://www.cms.gov/Medicare/Quality‐Initiatives‐Patient‐Assessment‐Instruments/
hospital‐value‐based‐purchasing/index.html?redirect=/hospital‐value‐based‐purchasing
Accessed on April 26, 2013
2015 Clinical Process of Care Measures will
Include:
Patient Experience (HCAHPS) measures will stay the same
http://www.cms.gov/Medicare/Quality‐Initiatives‐Patient‐Assessment‐Instruments/hospital‐value‐based‐purchasing/index.html?
redirect=/hospital‐value‐based‐purchasing Accessed on April 26, 2013
2015 Outcome and Efficiency Measures:
Outcome Measures
AHRQ (PSI-90)
Complication/patient safety for selected indicators
(composite)
CLABSI
Central line-associated bloodstream infection, all locations
– not just ICU
CAUTI
Catheter-associated urinary tract infection, all locations –
not just ICU
MRSA bacteremia
Lab ID
Methicillin-resistant S. aureus bacteremia using CDC’s
National Healthcare Safety Network (NHSN), long term
care hospital (LTCH)
C. Diff Lab ID
C. Difficile positive Lab. Test, NHSN, LTCH
MORT-30-AMI
Acute myocardial infarction 30-day mortality rate
MORT-30-HF
Heart Failure (HF) 30-day mortality rate
MORT-30-PN
Pneumonia (PN) 30-day mortality rate
Efficiency Measures
MSPB-1
Medicare spending per beneficary
http://www.cms.gov/Medicare/Quality‐Initiatives‐Patient‐Assessment‐Instruments/hospital‐value‐based‐purchasing/index.ht
ml?redirect=/hospital‐value‐based‐purchasing Accessed on April 26, 2013
Accreditation Agencies in U.S.
Healthcare Facilities
Founded by the American Osteopathic Association
(AOA)
 Granted "Deeming Authority" to conduct
accreditation surveys of acute care hospitals by
the Centers for Medicare & Medicaid Services
(CMS)


2009 Accreditation Requirements for Healthcare
Facilities;

More Details: http://www.hfap.org/
Accreditation Requirements in
U.S. Healthcare Facilities

Patient Safety Initiatives:
 07.01.02 /19-Prevent central line-assoc. bloodstream infection
 07.01.20 – Prevent Surgical Site Infections (SSIs)
 07.01.21 Hand Hygiene Guidelines
 07.01.02 Multidrug-resistant organism (MDRO) prevention
 07.01.24 & 25; Influenza Vaccination – healthcare personnel
 07.01.02 Care of the ventilated patient
 07.01.03 Prevent catheter-associated UTI (CAUTI)
Top cited condition level standards:
07.00.00 Infection Control
 CMS Condition of Participation: Infection Control.

The hospital must provide a sanitary environment to avoid sources and
transmission of infections and communicable diseases. There must be an active
program for the prevention, control, and investigation of infections and
communicable diseases.
Accreditation Requirements


Founded in 1951 by American College of
Physicians, AHA, AMA, Canadian Medical
Association, & American College of Surgeons
Accreditation Programs for:



Ambulatory, Behavioral Health Care, Critical Access
Hospital, Disease-Specific Care, Home Care,Hospital,
Lab, Long Term Care, Office-Based Surgery
Granted "Deeming Authority" to conduct
accreditation surveys by CMS
http://www.jointcommission.org
National Patient Safety Goals (NPSG),
Hospital, 2012





NPSG.07.01.01: Comply with CDC or WHO Hand Hygiene
Guidelines
NPSG.07.03.01: Implement evidence-based practices to
prevent health care–associated infections due to multidrugresistant organisms (MDROs)
NPSG.07.04.01: Prevent central line–associated
bloodstream infections (CLABSIs)
NPSG.07.05.01: Preventing surgical site infections (SSIs).
New NPSG 07.06.01; in full effect Jan. 2013:

Preventing Catheter-associated UTIs (CAUTI)
Accreditation Standards, 2012

IC.01.01.01:The [organization] identifies the
individual(s) responsible for the infection
prevention and control program

Element(s) of Performance (EP):


The hospital identifies the individual(s) with clinical authority over
the infection prevention and control program.
IC.01.02.01. Hospital leaders allocate needed
resources for the infection prevention and control
program.

Information, resources, equipment & supplies
Accreditation Standards, 2012

IC.01.03.01:The [organization] identifies risks for
acquiring and transmitting infections
 EPs:
 Identify risks- acquiring and transmitting infections,
based on: geographic location, community, and
population served.
 Care, treatment, and services it provides.
 Analysis of surveillance activities and other infection
control data.
 Review risks at least annually and whenever significant
changes occur
 Prioritizes the identified risks
Accreditation Standards, 2012

IC.01.04.01:Based on the identified risks, the hospital sets
goals to minimize the possibility of transmitting infections
 EPs:
 The hospital's written infection prevention and control
goals include the following:
 Addressing its prioritized risks.
 Limiting unprotected exposure to pathogens.
 Limiting the transmission of infections associated
with:
 procedures
 use of medical equipment, devices, and supplies.
 Improving compliance with hand hygiene guidelines
Accreditation Standards, 2012

IC.01.05.01:The [organization] has an infection
prevention and control plan.


Evidence-based national guidelines or, in the absence of such
guidelines, expert consensus.
The hospital’s infection prevention and control plan includes:






a written description of the activities, including surveillance, etc.
process to evaluate the infection prevention and control plan.
The hospital describes, in writing, the process for investigating
outbreaks of infectious disease.
All hospital components and functions are integrated into
infection prevention and control activities.
Communicating responsibilities about prevention to
independent practitioners, staff, visitors, patients, and families.
Methods for reporting infection surveillance and control
information to external organizations.
Example of Annual Infection Prevention &
Control Plan
Site of Infection /
focus
Goal(s)
Implementation
Strategies
Measurement
Surgical Site
Infections (SSI)
prevention
SSI SIR at or
below 1.0 for
applicable
procedure groups.
No razors
Preop Abx timing
SSI standardized
infection ratio
(SIR)
Normothermia…
Central LineAssociated
Bloodstream
Infections
(CLABSI
CLABSI at or
below 1.0
CLABSI
prevention bundle
CHG cleansing…
Analyze & Report
monthly trend
analysis of
CLABSIs
C. Difficile
infection
Rate of HA-CDI =
8.0/10,000 patient
days
Enhanced
environmental
disinfection
Real time feedback
Incidence of HACDI by inpatient
unit
Accreditation Standards, 2012

IC.01.06.01: The hospital prepares to respond to
an influx of potentially infectious patients.






Identify resources that can provide information about infections that
could cause an influx of potentially infectious patients.
Obtain current clinical and epidemiological information from its
resources regarding new infections that could cause an influx of
potentially infectious patients.
Method for communicating critical information to licensed independent
practitioners and staff about emerging infections that could cause an
influx
Describe, in writing, how it will respond to an influx of potentially
infectious patients.
Response plan for managing these patients over an extended period
of time.
See also, Emergency Management (EM) chapter;
emergency operations plan, etc.
Accreditation Standards, 2012

IC.02.01.01: The [organization] implements its infection
prevention and control plan.
 Standard & transmission-based precautions
 Outbreak investigation
 Minimize risk of cross transmission from medical waste
 …communicate responsibilities for preventing and
controlling infection to personnel, visitors, patients, and
families, e.g. hand and respiratory hygiene practices
 Report findings from surveillance to appropriate personnel
 Transfer notification “infection requiring action”:
 Receiving organization, e.g. MDRO detected prior to
discharge
 Referring organization, e.g. MDRO detected after
admission
Accreditation Standards, 2012

IC.02.02.01: The [organization] reduces the risk
of infections associated with medical equipment,
devices, and supplies.

The hospital implements infection prevention and
control activities when doing the following:





Cleaning and disinfecting medical equipment, devices, and
supplies.
Sterilizing medical equipment, devices, and supplies.
Disposing of medical equipment, devices, and supplies.
Storing medical equipment, devices, and supplies.
When reprocessing single-use devices, the hospital
implements infection prevention and control activities
that are consistent with regulatory and professional
standards.
The Case of the Unpackaged
Laryngoscope Blade

Blade = semicritical device; contact with mucous
membrane



The surveyor finding: unpackaged blades in a
anesthesia cart drawer.
Response Strategies; after cleaning:




Handle = noncritical
High level disinfection then package ea. blade in disposable,
closable plastic bag …OR…
Steam sterilize blades and then package each in closable,
plastic bag…OR…
Pre-packaged disposable blades – discard after each use
Evid.-based guidelines; Prev. of HC assoc. Pneu., 2003



A. Sterilization or Disinfection and Maintenance of
Equipment and Devices
1. a. Thoroughly clean all equipment and devices to be
sterilized or disinfected (category Ia)
1. b. After disinfection, proceed with appropriate rinsing,
drying, and packaging,… (category Ia)
See also:
Manufacturer’s
Instr. For Use
(IFU)
Accreditation Standards, 2012

IC.02.03.01: The [organization] works to prevent
the transmission of infectious disease among
[patient]s, licensed independent practitioners, and
staff.



The hospital makes screening for exposure and/or immunity to
infectious disease available to licensed independent practitioners
(LIPs) and staff who may come in contact with infections at the
workplace.
Referral mechanisms for LIPs or staff who have, or are suspected of
having, an infectious disease that puts others at risk that provides
them with or refers them for assessment, testing, immunization,
prophylaxis/treatment, or counseling.
Provide or refer for assessment, testing, immunization,
prophylaxis/treatment, or counseling of personnel after occupational
exposure or, if applicable, for patients exposed to infectious diseases.
Accreditation Standards, 2012

IC.02.04.01: The [organization] offers vaccination against
influenza to licensed independent practitioners and
staff.The hospital makes screening for exposure and/or
immunity to infectious disease available to licensed
independent practitioners (LIPs) and staff who may come in
contact with infections at the workplace.
 Annual influenza vaccination program that is offered to
LIPs and staff.
 Education for LIPs and staff about:





influenza vaccine;
non-vaccine control and prevention measures; and
the diagnosis, transmission, and impact of influenza.
Provide influenza vaccination - make accessible
Annual evaluation and increase vaccination rates
Accreditation Standards, 2012

IC.03.01.01: The [organization] evaluates the
effectiveness of its infection prevention and control
plan.


Evaluate the effectiveness of its infection prevention and
control plan annually and whenever risks significantly
change.
The evaluation includes:





infection prevention and control plan's prioritized risks.
Goals
Implementation of the infection prevention and control plan’s
activities.
Findings from the evaluation are communicated at least
annually to the individuals or interdisciplinary group that
manages the patient safety program.
Use findings of its evaluation when revising the plan.
Additional Accreditation AgenciesDet Norske Veritas (DNV) Healthcare, Inc
 http://www.dnv.com/industry/healthcare/
Accreditation Association for Ambulatory Health
Care
 www.aaahc.org
American Association for Accreditation of
Ambulatory Surgery Facilities
 www.aaaasf.org
CMS Conditions of Participation (CoP) and
Conditions for Coverage (CfC)
http://www.cms.gov/Regulations-andGuidance/Legislation/CFCsAndCoPs/index.html?redirect=/CFCsAndCoPs
/06_Hospitals.asp
OR, closer to home:
http://www.michigan.
gov/lara/
Follow links to Bureau
of Health
Systems then
hospitals, home
Health, etc.
Regulatory Requirements
for IPC Program
§ 482.42 Condition of participation: Infection control.
• The hospital must provide a sanitary environment to
avoid sources and transmission of infections and
communicable diseases. There must be an active program
for the prevention, control, and investigation of infections
and communicable diseases.
Regulatory Requirements
for IPC Program
Revisions, 5/16/2012§ 482.42 Condition of participation: Infection control.
a) Standard: Organization and policies. A person or persons
must be designated as infection control officer or officers to
develop and implement policies governing control of
infections and communicable diseases. The infection control
officer or officers must develop a system for identifying,
reporting, investigating, and controlling infections and
communicable diseases of patients and personnel.


§482.42 Condition of Participation: Infection
Control; revisions, 5/16/12
Standards (A748-A756)


•
System developed by IC officer for identifying,reporting,
investigating, and controlling infections and communicable
diseases
CEO, medical staff, and nursing director ensure QAPI*
program address problems identified in infection
prevention and control program
Quality assessment and performance improvement (QAPI)
(1) Ensure that the hospital-wide quality assessment and
performance improvement (QAPI) program and training programs
address problems identified by the infection control officer or
officers; and
§ 482.41 Condition of participation: Physical
environment
The hospital must be constructed, arranged, and
maintained to ensure the safety of the patient, and
to provide facilities for diagnosis and treatment
and for special hospital services appropriate to the
needs of the community.

Facilities, supplies, and equipment must be
maintained to ensure an acceptable level of safety
and quality.

There must be proper ventilation, light, and
temperature controls in pharmaceutical, food
preparation, and other appropriate areas.
§482.42 Interpretive Guidelines -State
Operations Manual, 12-22-2011
Infection Control Officer (ICO)
incl. hospital epidemiologists (HEs) or ―infection control professionals
(ICPs). (APIC & MSIPC = Infection Preventionist)
 a person(s) whose primary training is in either nursing, medical
technology, microbiology, or epidemiology and who has acquired
specialized training in infection control.
Designated in writing
 Qualified through education, training, experience, or certification (such
as that offered by the Certification Board of Infection Control and
Epidemiology Inc. (CBIC) – That’s why you are here!
Number of IPs not specified but needs to be adequate for the IPC
program

New IP Competency
Model, May 2012
issue of AJIC – tab 2
Supporting
Principles
• Competency is self
defined
• Competency is self
assessed
• Certification is
necessary
• Education
supports all levels
and aspects of
competency
CIC Matters: Pogorzelska M, et al AJIC 2012
or… CIC is more effective against MRSA than vancomycin,
linezolid, & quinupristin/ dalfoprinstin combined!
“Having a director with CIC was an independent
predictor of lower MRSA BSI rates”
See also the following studies that all found
correlation between CIC and implementation of
evidence based practices:
•
•
•
Krein SL, Hofer TP, Kowalski CP, et al. Use of central venous catheter-related
bloodstream infection practices by US hospitals. Mayo Clin Proc.
2007;82(6):672-678.
Krein SL, Kowalski CP, Damschroder L, et al. Preventing ventilator-associated
pneumonia in the United States: A multicenter mixed-methods study. Infect
Control Hosp Epidemiol 2008; 29:933-940
Saint S, Kowalski CP, Kaufman SR, et al. Preventing hospital-acquired urinary
tract infection in the United States: A national study. Clin Infect Dis 2008;
46:243–50.
Socio-Adaptive Skills : New Horizons for IPs in
the 21st Century; Sanjay Saint, MD – U of M Patient Safety
Enhancement Program , SHEA Annual Conference, 2011
Future training should ideally include:
• Implementation science
• Leadership and management
• Communication skills
• Teamwork
• Negotiation
• Human factors engineering
• Organizational behavior and group psychology
Will help us better deal with the reality of preventing
infection in real-world settings
CoP: Environment of Care
A-0726 §482.41(c)(4) - There must be proper
ventilation, light, and temperature controls in
pharmaceutical, food preparation, and other
appropriate areas
 “… Temperature, humidity and airflow in
anesthetizing locations must be maintained
within acceptable standards to inhibit
microbial growth, reduce risk of infection, control
odor, and promote patient comfort ”

Tools for Survey Readiness from CMS:
Hospital
Ambulatory Surgical Centers
Growth in Ambulatory Care

Shift in healthcare delivery from acute care
settings to ambulatory care, long term care and
free standing specialty care sites



Approximately 1.2 billion outpatient visits / year
Number of Dialysis Centers


Infection control oversight often lacking
2008: 4,950 (72% increase since 1996)
Number of Ambulatory Surgical Centers


2008: 5,100 (240% increase since 1996)
2007: More that 6 million surgeries performed in ASCs
Increasing numbers of surgical
procedures are moving from the
inpatient to the outpatient setting
Procedures (millions)
Outpatient
Settings
Inpatient
1
9
8
1
Source: Avalere Health analysis of Verispan’s Diagnostic Imaging Center Profiling Solution, 2004, and
American Hospital Association Annual Survey data for community hospitals, 1981-2004.
*2005 values are estimates.
2005
Why Are Ambulatory Surgical Centers (ASCs) &
Other Ambulatory Care Settings Under Scrutiny?
Surgical Tech Sparks Hep C Outbreak
Friday, July
17, 2009
State Health Department Posts Case
Numbers Associated with Hepatitis C
Investigation
Nevada Field Investigation of
Hepatitis C Transmission in Ambulatory
Surgery Centers
• Discovered reuse of syringes and
single dose vials
• Resulted in massive patient
notification: risks of bloodborne viral
infections due to unsafe injection
practices
HI
AK
DC
ASC Conditions for Coverage (CfC)
§416.51 Condition: Infection Control
“The ASC must maintain an infection control
program that seeks to minimize infections and
communicable diseases.” – effective 05/18/2009
Standards (Q241-Q245)
 Sanitary Environment
 Ongoing IC program following IC guidelines
 Qualified professional directs IC program
 IC program an integral part of QAPI
 IC program has a plan of action for combating
infections and communicable diseases
Sanitary Environment Needs Also Apply
to ASC
19% of facilities did not appropriately clean
high-touch surfaces in patient care areas
Schaefer MK, et al.
JAMA. 2010;303:2273-2279
Tools for Survey Readiness from CMS: ASC