Acute & Ambulatory Care Settings

Russ Olmsted, MPH, CIColmstedr@trinity-health.org

Accreditation & Regulatory Requirements for the Infection Prevention & Control Program

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 ImprovementThe Vision of Health Care in the U.S. 2012 -

Volume-driven

healthcare

VALUE-driven

healthcare

Cost

Quality

• Fragmented• Fee-for-service

• Connected• Bundled• Accountable

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

http://www.cms.gov/Medicare/Quality‐Initiatives‐Patient‐Assessment‐Instruments/hospital‐value‐based‐purchasing/index.html?redirect=/hospital‐value‐based‐purchasingAccessed on April 26, 2013

Tranquil GardensNursing Home

HomeCare

Acute Care

Facility

Outpatient/Ambulatory

Facility

Long Term CareFacility

Crossing the Chasm: New Era of Accountability & Value-Based Care

No facility is an“island”

Making The Case for Jumping the Chasm: the portable patient!

Huang SS et al. Infect Cont Hosp Epidemiol 2010

Interfacility sharing of patients, Orange County, California, 2005Each hospital = unique color ; 29% of patients had > 2 admissionsOf those with > 2 adms. 75% transferred between facilities

The Portable Patient, continued. .

Won S Y et al. Clin Infect Dis. 2011;53:532-540

3 different phases of investigation of inter-facility trans. of carbapenem-prod. K.pneumoniae

24 (60%) of 40 cases were linked to LTACH-A

The Portable Patient, continuedMicrobial 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

Case Study: George & C. difficile 1) Visits his primary care

provider; receives Rx for antibiotic for

LRI2) Falls @ home and breaks his

leg, admitted to “hospital A”

acquires C. difficile3) 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

American Recovery and Reinvestment Act (ARRA), 2009.Public Law 111-5

Action Plan to Prevent HAIs, June 2009http://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

Wright D. HHS Roadmap to Elimination of HAIshttp://www.hhs.gov/ash/initiatives/hai/actionplan/index.html

2011• 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

2013

• HCP Influenza Vaccination – ASCs (Oct.)• SSI – Cancer Hospitals (Jan.)• HCP Influenza Vaccination – IRF (Oct.)

2014

• CLABSI – Acute Care ICUs (Jan.)

• 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.)

2015

Federal HAI Reporting To NHSN Under Inpt. Quality Reporting:

Past/present & Future

• 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 samehttp://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.html?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 multidrug-resistant 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)

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.

Accreditation Standards, 2012

Example of Annual Infection Prevention & Control PlanSite 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 bundleCHG cleansing…

Analyze & Report monthly trend analysis of CLABSIs

C. Difficile infection

Rate of HA-CDI = 8.0/10,000 patient days

Enhanced environmental disinfectionReal time feedback

Incidence of HA-CDI by inpatient unit

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.

Accreditation Standards, 2012

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’sInstr. For Use(IFU)

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.

Accreditation Standards, 2012

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-and-Guidance/Legislation/CFCsAndCoPs/index.html?redirect=/CFCsAndCoPs/06_Hospitals.asp

OR, closer to home:http://www.michigan.gov/lara/

Follow links to Bureau of HealthSystems then hospitals, homeHealth, etc.

§ 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.

Regulatory Requirements for IPC Program

§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 environmentThe 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, 12-22-2011Infection 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

Supporting Principles• Competency is

self defined• Competency is

self assessed• Certification is

necessary• Education

supports all levels and aspects of competency

New IP Competency Model, May 2012 issue of AJIC – tab 2

CIC Matters: Pogorzelska M, et al AJIC 2012or… 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.

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

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

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

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

Increasing numbers of surgical procedures are moving from the inpatient to the outpatient setting

Source: Avalere Health analysis of Verispan’s Diagnostic Imaging Center Profiling Solution, 2004, andAmerican Hospital Association Annual Survey data for community hospitals, 1981-2004.*2005 values are estimates.

Outpatient Settings

Inpatient

Pro

cedu

res

(mill

ions

)

1981

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

DC

AK

HI

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

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