1. Accreditation & Regulatory Requirements for the Infection Prevention & Control Program
Acute & Ambulatory Care Settings Russ Olmsted, MPH, CIC

2. 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

3. Volume-driven healthcare VALUE-driven healthcare
Platform for Performance Improvement The Vision of Health Care in the U.S
Fragmented
Fee-for-service
Volume-driven healthcare
Cost
VALUE-driven healthcare
Connected
Bundled
Accountable
Quality 3 3

4. Value Based Purchasing- Definition
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
hospital‐value‐based‐purchasing/index.html?redirect=/hospital‐value‐based‐purchasing
Accessed on April 26, 2013

5. 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

6. 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

7. The Portable Patient, continued. .
3 different
phases of
investigation of inter-facility
trans. of
carbapenem-
prod. K.
pneumoniae
24 (60%) of 40 cases were linked to LTACH-A
Exposure network graphs delineating the relationships of cases to long-term acute care hospitals (LTACHs), acute care hospitals, and nursing homes during 3 epidemiologic periods. Case patients and facilities to which case patients were linked are connected by arrows or by nondirectional lines. An arrow from a facility to a case patient indicates that the patient acquired Klebsiella pneumoniae carbapenemase (KPC)–producing Enterobacteriaceae while at the facility. An arrow from a case patient to a facility indicates that the patient arrived at the facility already colonized or infected with KPC-producing Enterobacteriaceae (ie, the patient brought KPC-producing Enterobacteriaceae to the facility and may have acted as a vector of transmission there). Nondirectional lines link case patients and facilities if the facility of acquisition could not be determined. Black arrows or lines link case patients and facilities when a case patient had a KPC-producing bacterial isolate identified in a clinical culture. Red arrows or lines link case patients and facilities when a case patient had a KPC-producing bacterial isolate identified only in a routine admission surveillance culture, not in a clinical culture; routine admission surveillance cultures were collected only at LTACH-A. A, period 1 (from 1 January through 12 May 2008). B, period 2 (from 13 May through 13 August 2008). C, period 3 (from 14 August through 31 December 2008).
Won S Y et al. Clin Infect Dis. 2011;53:

8. The Portable Patient, continued
Microbial Highways:
Networks of inter-
facility transmission
of carbapenemase-
prod. K. pneumoniae
4 adjacent counties, IN
& IL
40 patients (11 [27.5%]
Fatal infection)
24/60 (60%) cases
assoc. with LTAC “A”
Cluster reached 14
Hosp., 2 LTAC, & 10
LTCFs.
Won SY, et al. Clin Infect Dis 2011

9. Case Study: George & C. difficile
Visits his primary care provider;
receives Rx for antibiotic for LRI
2) 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

10. External Drivers: Rise of Consumer Driven Legislation

11. Action Plan to Prevent HAIs, June 2009
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

12. Wright D. HHS Roadmap to Elimination of HAIs

13. Federal HAI Reporting To NHSN Under Inpt
Federal HAI Reporting To NHSN Under Inpt. Quality Reporting: Past/present & Future
2011
CLABSI – Acute Care ICUs (Jan.)
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)
2012
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.)
2013
HCP Influenza Vaccination – ASCs (Oct.)
SSI – Cancer Hospitals (Jan.)
HCP Influenza Vaccination – IRF (Oct.)
2014
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.)
2015
APIC. Federal HAI Reporting to NHSN resource update /17/13

14. The Future of VBP Domains
hospital‐value‐based‐purchasing/index.html?redirect=/hospital‐value‐based‐purchasing
Accessed on April 26, 2013

15. 2015 Clinical Process of Care Measures will Include:
Patient Experience (HCAHPS) measures will stay the same
Accessed on April 26, 2013

16. 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
Accessed on April 26, 2013

17. 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:
Holmes concluded that puerperal fever was often carried from patient to patient by physicians and nurses

18. Accreditation Requirements in U.S. Healthcare Facilities
Patient Safety Initiatives:
/19-Prevent central line-assoc. bloodstream infection
– Prevent Surgical Site Infections (SSIs)
Hand Hygiene Guidelines
Multidrug-resistant organism (MDRO) prevention
& 25; Influenza Vaccination – healthcare personnel
Care of the ventilated patient
Prevent catheter-associated UTI (CAUTI)
Top cited condition level standards:
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.
Holmes concluded that puerperal fever was often carried from patient to patient by physicians and nurses

19. 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
Holmes concluded that puerperal fever was often carried from patient to patient by physicians and nurses

20. National Patient Safety Goals (NPSG), Hospital, 2012
NPSG : Comply with CDC or WHO Hand Hygiene Guidelines
NPSG : Implement evidence-based practices to prevent health care–associated infections due to multidrug-resistant organisms (MDROs)
NPSG : Prevent central line–associated bloodstream infections (CLABSIs)
NPSG : Preventing surgical site infections (SSIs).
New NPSG ; in full effect Jan. 2013:
Preventing Catheter-associated UTIs (CAUTI)

21. Accreditation Standards, 2012
IC :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 Hospital leaders allocate needed resources for the infection prevention and control program.
Information, resources, equipment & supplies
Holmes concluded that puerperal fever was often carried from patient to patient by physicians and nurses

22. Accreditation Standards, 2012
IC :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
Holmes concluded that puerperal fever was often carried from patient to patient by physicians and nurses

23. Accreditation Standards, 2012
IC :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
Holmes concluded that puerperal fever was often carried from patient to patient by physicians and nurses

24. Accreditation Standards, 2012
IC :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.
Holmes concluded that puerperal fever was often carried from patient to patient by physicians and nurses

25. 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
Normothermia…
SSI standardized infection ratio (SIR)
Central Line-Associated 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 HA-CDI by inpatient unit

26. Accreditation Standards, 2012
IC : 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.
Holmes concluded that puerperal fever was often carried from patient to patient by physicians and nurses

27. Accreditation Standards, 2012
IC : 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
Holmes concluded that puerperal fever was often carried from patient to patient by physicians and nurses

28. Accreditation Standards, 2012
IC : 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.
Holmes concluded that puerperal fever was often carried from patient to patient by physicians and nurses

29. The Case of the Unpackaged Laryngoscope Blade
Blade = semicritical device; contact with mucous membrane
Handle = noncritical
The surveyor finding: unpackaged blades in a anesthesia cart drawer.
Response Strategies; after cleaning:
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)

30. Accreditation Standards, 2012
IC : 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.
Holmes concluded that puerperal fever was often carried from patient to patient by physicians and nurses

31. Accreditation Standards, 2012
IC : 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
Holmes concluded that puerperal fever was often carried from patient to patient by physicians and nurses

32. Accreditation Standards, 2012
IC : 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.
Holmes concluded that puerperal fever was often carried from patient to patient by physicians and nurses

33. Additional Accreditation Agencies-
Det Norske Veritas (DNV) Healthcare, Inc
Accreditation Association for Ambulatory Health Care
American Association for Accreditation of Ambulatory Surgery Facilities

34. CMS Conditions of Participation (CoP) and Conditions for Coverage (CfC)
OR, closer to home:
Follow links to Bureau of Health
Systems then hospitals, home
Health, etc.

35. 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.

36. Regulatory Requirements for IPC Program
Revisions, 5/16/2012-
§ 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.

37. §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

38. § 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.

39. §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 39

40. 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

41. 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):
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:
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.

42. 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

43. 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 ”

44. Tools for Survey Readiness from CMS: Hospital

45. Ambulatory Surgical Centers

46. Growth in Ambulatory Care
Shift in healthcare delivery from acute care settings to ambulatory care, long term care and free standing specialty care sites
Infection control oversight often lacking
Approximately 1.2 billion outpatient visits / year
Number of Dialysis Centers
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 46

47. Procedures (millions)
Increasing numbers of surgical procedures are moving from the inpatient to the outpatient setting
Outpatient Settings
Procedures (millions)
Inpatient
1981
Source: Avalere Health analysis of Verispan’s Diagnostic Imaging Center Profiling Solution, 2004, and
American Hospital Association Annual Survey data for community hospitals,
*2005 values are estimates.
2005 47

48. 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

49. 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 DC AK HI

50. ASC Conditions for Coverage (CfC)
§ 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
As stated in the CFR, the ASC must maintain an infection control program that seeks to minimize infections and communicable diseases. 50

51. 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:

52. Tools for Survey Readiness from CMS: ASC