Where the Rubber Meets the Road

1
Where the Rubber Meets the Road
SB 739

• Jan 08 version (2) presented
• (insert your chapter, current date here)
• Sue Chen RN, MPH, CIC
• HAI Program Coordinator
• California Dept of Public Health
• Sue.Chen_at_cdph.ca.gov

2
Objectives

• SB 739 in context
• History of mandatory reporting
• Making the business case
• Review of SB 739 requirements
• Your role in implementation of SB 739
  (devil is in the details)
• Introduction to NHSN
• Sequence of events/specific activities
• Updates from HAI-AC to CDPH
• Say amen and escape

3
Number of nosocomial pathogens, according to
infection site, identified in the hospital-wide
component of the NNISprogram from January 1990
to March 1996
HAIs- The Big Four

• Urinary tract infections
• (catheter-associated)
• Surgical site
• Infections
• Bloodstream infections
• (central line-associated)
• Pneumonia
• (ventilator-associated)

4
Healthcare-Associated Infections Numbers and
Costs
From Klevens et al..Public Health Rep.
2007122160-6 12 of U.S.
5
Cost of HAI vs. Infection ControlDuke Infection
Control Outreach Network

• 28 community hospitals (30-616 beds)
• 25,072 for VAP 23,242 per CLA BSI
• 10,443 per SSI 758 per CAUTI
• Ave cost of infections 594,683/year
• Ave annual budget for IC 129,000
• Decreasing HAIs by 25 would save 148,667 per
  hospital
• Anderson et al. Underresourced Hospital Infection
  Control and Prevention Programs Penny Wise,
  Pound Foolish. Infect Control Hosp Epidemiol
  2007 28767-773

6
What Hospitals Dont Get

• Two economists are walking down the street. One
  sees a dollar lying on the sidewalk, and says,
  Look, there is a dollar lying on the ground!
  Obviously not, says the other. If there were,
  someone would have picked it up!
• from Hollenbeak, APIC
  2007

7
Who Pays?

• Patients with HAI are disproportionally Medicare
  but only 50 Medicare-paid

8
Glimpse of the Future From Centers for Medicare
Medicaid Services

• Effective October 1, 2008, hospitals will no
  longer receive higher payments for the additional
  costs of treatment associated with following
  HAIs
• Catheter-associated urinary tract infections
• Vascular catheter-associated infections
• Surgical site infection mediastinitis after
  coronary artery bypass graft surgery
• Unless condition is present upon admission

9
History of Reporting of HAIs

• Florence Nightengale descriptive epidemiology
  during Crimean War documented causes of
  mortality
• National Nosocomial Infections Surveillance
  (NNIS)
• Epidemiology of HAIs, describe antimicrobial
  resistance, enable inter-hospital comparisons
• Study on the Efficacy of Nosocomial Infection
  Control (SENIC) Study
  1970s

Gill C, Gill G. Nightengale in Scutari Her
Legacy Reexamined. CID 200540.
10
Public Reporting Background

• The quality and safety of healthcare in the U.S.
  needs to improve
• Public reporting is one of a number of quality
  improvement methodologies adopted
• Public reporting of health care performance
  information is intended to
• Provide information to enable consumers to obtain
  safer care
• Stimulate and provide basis for quality
  improvement by reporting providers

11
Public Reporting Slide 2

• Indicators for public reporting can be
• Outcomes (e.g. mortality, infections)
• Processes (e.g. aspirin for MI, antibiotic within
  4 hours of admission for community-acquired
  pneumonia, appropriate antibiotic prophylaxis
  prior to surgery)
• Public reporting for myocardial infarction,
  coronary bypass graft surgery (CABG), and
  community-acquired pneumonia has been in place
  gt10 years
• Reductions in the rate of death associated with
  CABG in New York and Pennsylvania have been
  attributed, in part, to public reporting

12
Trend over time in bloodstream infections
associated w/ catheters in pediatric ICU

• Nov 1998 use of maximal barrier precautions
• July 1999 use of antibiotic-impregnated
  catheters
• March 2000 annual hand washing campaigns
• April 2003 move to new unit with private
  rooms
• May 2003 introduction of skin disinfection
  with chlorhexidine

U Arkansas Childrens Hospital Bhutta et. al.,
BMJ 2007334362-5
13
Leapfrog Report 9/18/07

• 87 hospitals (n1256) do not take all
  recommended steps to prevent HAIs
• 35.6 do not always follow hand hygiene practices
• 30.7 vaccinate staff against flu
• http//www.leapfroggroup.org/

14
Consumers Union

• Focus on obtaining data on HAIs so consumer
  can make an informed choice also
• pressures hospitals to improve
• legislation for mandatory reporting
• active surveillance cultures for MRSA
• Rep. Tim Murphy (PA) is sponsoring the "Healthy
  Hospitals Act of 2007" (HR1174). The bill will
  make you safer during a hospital stay by
  requiring public disclosure of hospital-acquired
  infection rates. If hospitals must tell you about
  their infections, they will work harder to reduce
  them.
• Please ask your representative to co-sponsor
  this bill!

15
Experience with Legislated Mandatory Public
Reporting

• Pennsylvania
• Have been reporting data since 2004
• Areas for improvement
• Use of administrative data
• Law of Unintended Consequences
• Pittsburg Regional Healthcare Initiative

Found error-prone systems that did not focus on
the patient at the point of care. Healthcare
must focus on delivering perfect healthcare to
every patient.
16
Response to Public Reporting Consumers Dont
Seem to Care..
Source CHCF sponsored survey of Californians,
2004
17
Quality of Care - Heart Attack
But Hospitals Do
Number of hospitals
18
California Ancient History

• Little Hoover Commission report April 10, 2003
  recommended increased capacity to fight HAIs
• HAI-AWG met from July 05-Feb 07
• Recommendations for Reducing Morbidity and
  Mortality in California Final Report to CDPH
  December 31, 2005
• Result was SB 739 signed into law September 28,
  2006

For those w/ attention deficit or CRS
19
SB 739 Mandates

• Implement an HAI surveillance program
• Electronic database NHSN
• By July 1, 2007
• Appoint an HAI Advisory Committee
• Hospitals must implement respiratory
  hygiene/cough etiquette program, employee flu
  vaccine program, disaster plan w/ pandemic flu
  component in conjunction w/ local health dept
• Educate health facility evaluators in HAI

20
Mandates contd

• On or after Jan 1, 2008
• Revise infection control-related portions of
  Title 22
• GAC shall implement and annually report process
  measures which are to be made public within 6
  months
• Central line insertion practices
• Influenza vaccination of HC personnel and high
  risk patients
• Surgical antimicrobial prophylaxis

21
Current Tasks and Further Directions Slide 1

• Facilities must enroll in NHSN soft deadline Jan
  31, 2008
• Be prepared to join CDPH group and give CDPH
  permission to see appropriate data elements
• Specific directions will be forthcoming from CDPH
  with details and start dates for mandated
  reporting.

22
Slide 2

• Use CLIP practice module to get process in place
  for data collection
• Be prepared to report vaccination rates for
  2007-08 flu season (model is TJC requirements)
• Respond to SCIP questionnaire by Jan 15. SCIP
  data will be required to be reported through
  CMS/Lumetra

23
Update on HAI_AC Recommendations

• Central Line Insertion Practice (CLIP)
• Influenza vaccine for
• Employees
• High risk patients
• Antimicrobial prophylaxis (SCIP)
• Legal
• Reporting of healthcare-associated MRSA infections

24
HAI-AC Central Line Insertion Practices (CLIP)

• Option 1 fill out all asterisked data points on
  CLIP form
• In ICUs x 6 months
• Option 2 fill out 6 areas AND do outcome module
  for those units
• AND
• Documentation of daily assessment of line
  necessity by a clinician.

25
HAI-AC Influenza Vaccination for Employees

• Publicly report influenza vaccination/
  declination rates for employees for 07-08
  season
• Differentiates between employees and healthcare
  workers
• Non-employee HCW should be offered vaccine a
  rate for this not mandated at this time
• Forms may only be obtained Sept-Mar

26
HAI-AC Surgical Care Improvement Project (SCIP)

• Will be reported through CMS/Lumetra
• Facilities currently reporting data will not have
  more work
• Facilities not currently reporting must work w/
  Lumetra to establish reporting pathway or
• If facility does not perform surgeries, no
  reporting will be required.
• CDPH will begin downloading CMS data at a
  to-be-announced date.

27
HAI-AC Recommendations for Mandatory Reporting of
MRSA

• Report all laboratory-confirmed MRSA bloodstream
  infections identified in hospitalized patients
• Classify as community-onset (day 1-3) or Hospital
  onset (day 4)
• Publicly report as of July 1, 2008
• number of community-onset
• Rate of hospital-onset/1000 inpatient days
• No further characterization required at this time

28
What is NHSN?

• CDC-sponsored voluntary, confidential system for
  monitoring events associated with health care
• Initial focus on infections in patients and
  healthcare personnel
• Expanding to include noninfectious events (such
  as process measures)
• Accessed through a secure, web-based interface
• Open to all US healthcare entities at no charge

29
NHSN is a Partnership!
NHSN participation was never designed or intended
to be the sole responsibility of Infection
Control.
30
Am J Infect Control 200735290-310
31

• Device-associated
• Procedure-associated
• Medication-associated

modules
32
Percentage of Hospitals in AHA Survey Enrolled
in NHSN
613 facilities
Status as of June 18, 2007
33
National Healthcare Safety Network (NHSN)for
State Reporting
Heavily Plagiarized by CDPH from CSTE 2007
Annual Conference presentation June 2007
R. Monina Klevens, DDS, MPH Division for
Healthcare Quality Promotion National Center for
Infectious Diseases
Heavily is not an infestation
34
Characteristics of NHSN Surveillance Methodology

• Active, patient-based, prospective,
  priority-directed collection of data
• Results in risk-adjusted incidence rates will
  allow comparison between yourself or group
  against national average.
• Intended to be used as a quality improvement tool
  to be of mutual benefit to facilities and NHSN
  goal to eventually link processes with outcomes

35
Authority and Confidentiality for NHSN

• Public Health Service Act (42 USC 242b, 242k, and
  242m(d))
• Confidentiality Protection
• Sections 304, 306, and 308(d) of the PHS Act

The information contained in this surveillance
system that would permit identification of any
individual or institution is collected with a
guarantee that it will be held in strict
confidence, will be used only for the purposes
stated, and will not be disclosed or released
without the consent of the individual, or the
institution in accordance with Sections 304, 306,
and 308(d) of the Public Health Service Act (42
USC 242b, 242k, and 242m(d)).
36
Strengths Built on NNIS Experience

• NNIS System is a model for patient safety1,2
• High quality data can be used for performance
  improvement. Reductions in national infection
  rates have been achieved.
• Scientific credibility Definitions and methods
  adopted internationally
• Timely data can be immediately downloaded
• Aggregate comparisons by unit or procedure across
  states ensure greater numbers

1Leape LL. Reporting of adverse events. NEJM
20023471633-8. 2Burke JP. Infection controla
problem for patient safety. NEJM 2003 348651-6.
37
Registration ProcessFollow the Balloons and
Arrows
Accept Rules of Behavior
NHSN sends email w/ instructions for digital
certificate
You read and follow directions carefully
complete modules
NHSN sends further instructions
You read and follow directions carefully sign
away first born
Etc. Etc. Etc. (From Facility Administrator Enrol
lment Guide)
38
Process for Hospitals to Register

• http//www.cdc.gov/ncidod/dhqp/nhsn_members.html
• Accept rules of behavior
• Part of registration is to complete 8 modules
  (2 hrs each)
• On R side of page NHSN Resources, click on
  Training, then Archived Training, follow
  stepwise directions
• Name a facility administrator person with all
  rights to all data for your facility

39
Registration Process Contd

• Obtain (and dont lose) digital certificate
• If firewalls prevent access, own IT dept must
  clear site
• Fill out online form and survey
• Name group/groups
• Send to NHSN
• CDC will activate facility
• Facility must join CDPH group, give rights to see
  mandated data

40
Summary of NHSN Rules

• Every month, the facility must submit a
  surveillance plan
• Facility must report data to NHSN 6 of every 12
  calendar months within 30 days of end of
  reporting period
• Failure to adhere to reporting can result in loss
  of member status
• Loss of member status puts facility at odds w/
  mandates of SB 739
• All data fields marked w/ an asterisk must be
  filled out for record to be counted if in plan

41
I certify that I completed the required training
to participate in the National Healthcare
Safety Network
Registration Nirvana?
Name of participant
Name of facility
Dates of training
42
How CDPH Accesses Data in NHSN

• Groups e.g., healthcare corporations, State
  Health Departments
• A facility nominates CDPH
• Facilities join the group and confer some/all
  rights to data
• Facilities within the group cannot see each
  others data
• Group sees data from all facilities as granted
• After joining, a facility can use any NHSN module
  (ex outcome measure) they choose data not
  visible to CDPH except w/ permission

43
Limitations

• Primary experience with voluntary, confidential
  reporting
• Validation methods in development
• Labor intensive
• And deadlines for data reporting
• No special protocols for small hospitals
• Not tied to utilization or billing data directly
  (DRGs, ICD9/10, etc.)
• Must follow NHSN rules

44
Support for States Users

• Collaboration with APIC/CACC, CSTE, SHEA, IDSA
• NHSN State Users Group
• Conference calls monthly/Webboard to share
  materials, including users newsletter
• Training for all members
• Webinars
• Interactive distance learning
• nhsn.cdc.gov

45
What and When States Using NHSN are Reporting
PA CA
VA WA
SC
NY
CO
VT
OK
DE
TN
Jan 2007
2008
Undefined measures
46
Anticipated Additions

• Process modules for CLIP and immunizations (for
  both employees and patients) to be released Feb
  08
• Introduction of 23 modules of interactive
  computer training (20-30 min ea) Jan 08
• In addition to original modules
• Number required will depend on rights conferred
• Goal to set up CEUS for module completion
• Will contain post-test to document knowledge
  minimal score of 80 to pass

47
What CDPH would like to see

• Formulation of a model for reporting of never
  events for nationwide use
• Downloading capacity from 3rd party vendors
  directly into NHSN
• Discussion between CMS, CDPH, and NHSN for direct
  download of SCIP data already reported to CMS
• Disclaimer While willing, CDC lacks personnel
  and monetary resources to develop these
  capacities at this time.

48
Challenges

• What are the evidence-based reporting best
  practices?
• Balance use of existing data with accuracy and
  ownership
• How to gain necessary resources for
  implementation of reporting?
• State and hospital levels
• More efficient methods
• How will reporting impact quality of care?
• Integrity of processes will drive decrease in
  infection rates
• Provider and consumer behavior

49
Questions?
Answers Cheap
50
Acknowledgements

• Jon Rosenberg
• Centers for Disease Prevention and Control
• New York State
• Audiences for
• refining the
• program

51

• Infectious Diseases Experts Applaud Bill Against
  "Bad Bugs"
• With extensively drug-resistant tuberculosis,
  life-threatening drug-resistant respiratory and
  skin infections, and other bad bugs routinely
  making headlines, infectious diseases physicians
  are applauding Rep. Jim Matheson (D-UT) and Rep.
  Michael Ferguson (R-NJ) for introducing H.R.
  3697, Strategies To Address Antimicrobial
  Resistance (STAAR) Act  

52
S.2278 Durbin Bill/H.R. 4214CHAI Reduction Act
of 2007

• Establish best practices guidelines for IC plans
  to treat and control CHAI in GAC
• Hospitals to begin reporting through NHSN within
  90 days
• CDC to be given authority to make rules
• Institute pay for performance
• Public awareness and education
• Ongoing interagency workgroup

Community-Associated and Healthcare-Associated
Infections
53
H.R. 4352 Assistance to School Districts to
Combat MDRO (Towns)

• 30 million to Dept of Education for prevention,
  outreach, educational activities in grades K-12
  for qualifying pathogens
• MRSA, CDC-identified life-threatening bacteria
• Money may cover personal hygiene supplies and
  disinfectants if school district lacks a
  sufficient budget.

Introduced Dec 11, 2007 D-NY
54
H.R. 4451 MRSA Research and Study Act of 2007
(Stearns)

• Establish 6 year grant program under auspices of
  Sec Health Human Services
• Eligibility under university or u-affiliated
  teaching hospital
• Minimum 25 grants awarded during each 2 year
  period 5 million ea

Introduction Dec 11, 2007 R-FL
55
S. 2526 Worker Infection Protection Act
(Menendez, Durbin, Kennedy)

• Proposal covers HCW, first responders, other
  workers _at_ risk against exposure to infectious
  agents and drug-resistant infections avian
  influenza, MRSA
• Sec of Labor to develop temporary exposure
  control plan w/ in 6 months permanent 6 mo later
  OSHA
• plan, PPE, training, medical surveillance,
  immunization if available

Introduced Dec 19, 2007 D-NJ, IL, MA
56
SB 1058 Medical Facility Infection Control
Prevention Act (Alquist)

• Health facilities and residential care facilities
  for the elderly must implement procedures for
  screening, prevention, and reporting of specified
  infections
• ASC for specified conditions
• Reporting
• Laboratory reporting of facility-acquired
  positive cultures to CDPH
• reporting of 2 or more cases MRSA within a 7 day
  period
• Facility must post that report on its website
• Cleaning of pt care equipment/environmental
  surfaces
• Adequate infection control staffing 1100
  occupied inpatient beds, 1200 outpatient visits.
  Same ratios of IC required for residential care
  facilities.
• Staff must be adequately trained
• Introduced Jan 8, 2008 by E Alquist, D-Santa
  Clara

57
Definition of Reportable CA Staph

• Severe staph infection resulting in death or ICU
  admission in a previously healthy person
• Covers both MRSA and MSSA
• Will be reported through local health dept via
  CMR
• Estimated burden of reporting 100-200 cases/year
  in CA
• Primary responsibility for reporting belongs to
  local health departments
• CDC definition of previously healthy
• Persons who have not been recently (within the
  past year) hospitalized or had a medical
  procedure (such as dialysis, surgery, catheters)