PMDA Public Policy Committee Report 20072008

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PMDA Public Policy Committee Report2007-2008

• Thomas Lawrence, MD
• David A. Nace, MD, MPH
• Co-Chairs, PMDA Public Policy Committee
• tomlawrence_at_comcast.net
• naceda_at_upmc.edu

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Im David Nace and I approved this message
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Objectives

• Review Act 52 key points Healthcare Facilities
  Act
• Discuss new developments on Act 52
• Discuss F 441-444 Infection Control and Hand
  Hygiene Regulations
• Discuss HHS HCW influenza Initiative (Priority)
  late season immunization push
• Discuss HB 2098 Preventable Serious Adverse
  Events Act

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Healthcare Associated Infections Act (Act 52)

• Health Care Facilities Act
• Signed into law July 2007
• Intent to reduce healthcare associated infections
  in PA healthcare facilities
• Includes nursing facilities
• Key agencies
• Patient Safety Authority
• Health Care Cost Containment Council
• DOH

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Act 52 - 6 Key Components

• Comprehensive Infection Control Plan
• Active Surveillance System
• Electronic Reporting of HCAI
• Incentive Payments
• Surcharge
• Penalties

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Comprehensive Infection Control Plan

• Multi-disciplinary Committee (if applicable)
• Medical staff
• Administration
• Lab personnel
• Nursing staff
• Pharmacy staff
• Physical plant
• Patient Safety Officer
• Infection Control team
• Community member

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Comprehensive Infection Control Plan

• Effective measures for the
• Detection
• Prevention
• Control of HCAI

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Comprehensive Infection Control Plan

• Culture surveillance processes policies
• Surveillance for the HCAIs defined in the PA
  Bulletin
• Active case finding
• Role of the Infection Preventionist critical

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Comprehensive Infection Control Plan

• System to ID and designate patients known to be
  colonized or infected with MRSA/MDRO
• Must culture
• all nursing home residents
• admitted to the hospital
• Procedures for identifying other high risk
  residents admitted to hospital

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Comprehensive Infection Control Plan

• Procedures protocols for staff with potential
  exposure to resident known to be colonized or
  infected
• When to culture or screen
• TB
• MRSA outbreaks
• Prophylaxis
• Flu
• Follow-up care
• Needlestick injuries

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Comprehensive Infection Control Plan

• Outreach process for notifying receiving health
  care facility or ASF of any patient known to be
  colonized or infected prior to transfer
• Hospital transfers
• Ambulance transport
• Surgical centers
• Other NFs

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Comprehensive Infection Control Plan

• Infection Control Protocol
• IC Precautions
• CDC Guidelines
• Intervention Protocols
• Evidence based standards
• Physical Plant Operations
• Appropriate Use of Antimicrobials
• Mandatory Education Programs for Staff
• Fiscal / Human Resource Requirements

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Comprehensive Infection Control Plan

• Process for Patient Safety Advisories
• Healthcare workers
• Medical staff
• Physical plant personnel
• Patient Safety Authority
• http//www.psa.state.pa.us/psa/site/default.asp

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Electronic Reporting

• All NF must electronically report HCAI to DOH and
  PSA
• Definitions Finalized and published
• PA Bulletin 9/20/08
• Effective Date TBD
• April 1, 2009

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Electronic Reporting

• Mechanism
• PA Patient Safety Reporting System (PA-PSRS)
• Single web-based interface
• Format
• TBD
• Training
• In-person
• Across state Jan Mar 2009
• On-line

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Quality Incentive Payment

• Jan 1, 2009 - Payments for 10 reduction in total
  HCAI in facility
• 2010 benchmarks for reduction
• Must be compliant for payment
• Funds as available

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Nursing Home Assessment

• July 1, 2008 surcharge on license fee
• Maximum aggregate 1 million
• Penalty for failure to pay 1000 / day
• Reimbursable cost
• DPW to make a pass through payment to the facility

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Penalties

• Failure to report HCAI
• Failure to develop, implement, or comply with a
  plan
• 1000 / day

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Healthcare Associated Infection (HCAI)

• A localized or systemic condition that results
• from an adverse reaction to the presence of an
• infectious agent or its toxins that
• Occurs in a patient in a health care setting
• Was not present or incubating at the time of
  admission, unless the infection was related to a
  previous admission to the same setting.
• If occurring in a hospital setting, meets the
  criteria for a specific infection site as defined
  by the CDC and its National Health Care Safety
  network (NHSN)

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HAI Caveats

• HAI not present or incubating upon admission
• All signs and symptoms must be acute, new, or
  rapidly worsening
• Non-infectious causes should always be considered
  first before defining an infection
• Physician diagnosis plays a significant role,
  especially where lab and Xray resources are
  limited

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HAI Caveats

• Use of abx alone is not indicative of infection
• Fever in the elderly
• Oral or equivalent temp of 100.4 F (38C) or an
  increase of 2 F (1.1 C) over baseline.

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Reportable Conditions
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UTI

• Residents w / Urinary Catheter (Must have 2 or
  more)
• Fever /- chills
• Flank or suprapubic pain
• Gross hematuria or change in character of urine
• Change in MS or functional status from daily
  baseline
• Residents w / o Urinary Cather (Must have 3 or
  more)
• Fever /- chills
• New burning pain on urination, frequency, urgency
• Flank or suprapubic pain
• Gross hematuria or change in character of urine
• Change in MS or functional status from daily
  baseline

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UTI

• If urinalysis obtained, 1 or more must be
  positive IN the presence of signs and symptoms
• Positive leukocyte esterase
• Positive nitrite
• Pyuria (10 or more WBC)
• If urine culture obtained, must have signs and
  symptoms
• gt 100,000 colonies, AND
• No more than 2 organisms present

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Lower Respiratory Tract Infection

• Must have 3 or more
• Fever
• New or increased cough
• New or increased sputum
• Pleuritic chest pain (gets worse with breathing)
• Rhonchi, rales, wheezes or bronchial breathing
• New or increased SOB
• Tachypnea (gt 25 breaths/min)
• Change in MS or functional status from baseline
• No other conditions that could account for
  symptoms
• If CXR, physician confirmation of infiltrate with
  symptoms/signs

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Influenza-Like Illness

• Fever, AND
• 3 or more of the following
• Chills
• Headache or eye pain
• Malaise or loss of appetite
• Sore throat
• Dry cough
• Myalgias

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Skin Soft Tissue Infection(Cellulitus, IV
site, Burns, Vascular / diabetic ulcer, device
associated, decubitus ulcer)

• Purulent drainage, pustules or vesicles at wound,
  skin or soft tissue site, AND
• 4 or more of the following
• Fever
• Heat
• Redness
• Swelling
• Pain
• Serous drainage

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GI Tract

• 1 or more of the following
• 2 or more loose / watery stools above normal for
  the resident in 24 hour period
• 2 or more episodes of vomiting with 24 hour
  period
• Laboratory confirmed enteric pathogen from stool
  w/ compatible clinical syndrome
• Stool toxin assay for C difficile
• Single IgM or fourfold increase in IgG for
  pathogen in paired sera
• No evidence of non-infectious cause (meds, tube
  feeds, laxatives, PUD)
• C difficile is HAI if it presents after day 3 of
  admission

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Intra-abdominal Infection(peritonitis / abscess)

• 2 or more of the following
• Fever
• Nausea
• Vomiting
• Abdominal pain
• Jaundice
• AND one of the following
• Physician diagnosis of intra-abdominal process
• Xray evidence
• Organism cultured from drainage from surgically
  placed drain or tube

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Meningitis

• Physician diagnosis, AND
• 3 or more of the following
• Fever
• Headache
• Stiff neck
• Meningeal signs as per physician
• Cranial nerve signs as per physician
• Irritability

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Viral Hepatitis

• Positive antigen or antibody test for Hepatitis
  A, B, C, delta, AND
• 2 or more of the following
• Fever
• Nausea
• Anorexia
• Vomiting
• Abdominal pain
• Jaundice
• History of transfusion within previous 3 months

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Osteomyelitis

• Physician diagnosis AND
• 2 or more of the following
• Fever
• Localized swelling
• Tenderness at suspected site of bone infection
• Heat at suspected site of bone infection
• Drainage at suspected site of bone infection

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Primary Bloodstream Infection

• 2 or more blood cultures drawn on separate
  occasions documented with a common skin
  contaminant
• Diphtheroids, Bacillus, Proprionibacterium, coag
  neg staph, micrococci
• OR single blood culture documented with
  pathogenic organism (not a typical contaminant
• AND
• Fever
• Drop in systolic BP gt 30 mm Hg over baseline
• Change in MS
• Not related to infection at another site.

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Training

• DOH Training Grants LTCF
• 1000 per facility
• Identification
• Reporting
• Prevention
• November 26, 2008
• www.dsf.health.state.pa.us/health/cwp/browse.asp?a
  188bc0c38963

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Written Notification

• All Serious Events (SE) require that the
  healthcare facility notify the patient or their
  legal representative in writing that a SE has
  occurred. This written notification must occur
  within seven (7) calendar days.

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Written Notification

• 24 comments submitted regarding applicability of
  written notification requirements
• Act 13 did not include NF
• Act 52 did not specifically require this
• PMDA working with other organizations to remove
  this requirement
• NF setting is different than acute care
• High percentage of care maintenance and
  palliative / end of life care
• Most such patients will ultimately have an
  infection at time of death which is neither
  avoidable or unexpected.

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PMDA PositionWritten Notification

• While PMDA strongly supports disclosure of
  medical errors, PMDA specifically opposes a
  mandatory requirement for written notification of
  healthcare associated infections in LTC
  facilities as defined by the PSA
• A majority of such infections as defined by the
  PSA will not be preventable (and hence not
  represent system failures)
• Infection is a common and expected mode of death
  for those whose care wishes are for either care
  maintenance or palliative care (as opposed to
  life sustaining care wishes)

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F 441-445 Federal Nursing Facility Licensure
RegulationsInfection Control
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F 441-445

• January 2007 began revision of F 441-445
• F 441 - Infection Control Infection Control
  Program (483.65 483.65a)
• F 442 Preventing Spread of Infection (483.65b)
• F 443 Staff with Communicable Diseases
  (483.65(b)(2))
• F 444 Hand Washing (483.52 (b)(3))
• F 445 Linen Handling (483.65(c))

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F 441-445

• September 2008 final revised guidelines back to
  CMS
• Collapsed all tags into two
• F 441 Infection Control
• F 444 Hand Washing
• Release for Stakeholder comment September 17,
  2008
• Due back October 31, 2008

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F 441-445

• Expert panel will meet to review comments first
  week of November

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Health workers administer flu and pneumonia
inoculations at Embarkation Camp in Genicart,
France, during the 1918 flu pandemic.
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Health Human Services Healthcare Worker (HCW)
Influenza Immunization Initiative
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Healthcare Workers

• HCW are at risk for Getting the flu
• Personal Safety
• HCW are at risk for Giving the flu
• Patient Safety

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HHS HCW Influenza Immunizations

• Overall mortality reduced in LTC facilities when
  staff immunized against influenza.
• 40 reduction in several studies
• Healthy People 2010 goal is a 60 HCW influenza
  immunization rate
• National average is 37-40
• National average unchanged in past decade

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Study of Influenza Prevalence in HCWBMJ
19963131241-2.

• Percent Staff w / Flu Percent
  Flu Staff w / No Recollection of
  Infection
• 1993-1994 Glasgow
• 518 subjects, influenza A/B antibodies w/paired
  serum samples
• Survey questionnaire

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HHS HCW Influenza Immunizations

• HHS is requesting all healthcare workers be
  immunized against influenza
• HHS is requesting all healthcare provider
  organizations work with their membership to
  improve HCW influenza immunization rates.

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PMDA PositionHealthcare Worker Influenza
Immunization

• PMDA recommends all healthcare workers be
  immunized against influenza
• PMDA recommends that facilities include the use
  of a declination form in the HCW immunization
  programs

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Health Human Services Late Season Influenza
Immunizations
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Late Season Immunizations

• National Influenza Vaccination Week
• DECEMBER 8-14, 2008
• Provider immunization efforts typically end
  November
• Flu doesnt end in November or December

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PMDA PositionLate Season Influenza Immunizations

• Healthcare providers should continue to immunize
  all LTC residents through the end of flu season
• APRIL or MAY depending on the season
• Healthcare providers consider observing National
  Influenza Vaccination Week

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PA House Bill 2098 Preventable Serious Adverse
Events Act
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PA House Bill 2098 Session of 2007

• Objective
• Reduction in payment for preventable serious
  adverse events within the Commonwealth
• Health care providers may not knowingly seek
  payment from health payors or patients for a
  preventable serious adverse event or services
  required to correct or treat the problem created
  by such an event when such an event occurred
  under their control.

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PA House Bill 2098 Session of 2007

• Health care providers
• A healthcare facility or a person, including a
  corporation, University, or other educational
  institution, licensed or approved by the
  Commonwealth to provide health care or
  professional medical services.
• Physicians, nurse midwifes, podiatrists, CRNP,
  PA, chiropractor, hospitals, ASC, nursing homes,
  or birth centers.

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PA House Bill 2098 Session of 2007

• Preventable Serious Adverse Event
• An event that occurs in a healthcare facility
  that is within the healthcare providers control
  to avoid, but that occurs because of an error or
  other system failure and results in a patients
  death, loss of body part, disfigurement,
  disability or loss of bodily function lasting
  more than 7 days or still present at the time of
  discharge from a healthcare facility.
• Such events shall be within the list of
  reportable serious events adopted by the National
  Quality Forum

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PA House Bill 2098 Session of 2007

• Passed by House
• Referred to Senate
• Senate session ended before passage
• PMS
• Key is in the wording of preventable serious
  adverse events
• Will pass

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PMDA PositionHouse Bill 2098

• No position at this time
• Under review
• Engage in discussion
• definitions

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Leadership

• Leadership is communicating to a person, their
  worth potential so clearly that they come to
  see it in themselves
• Stephen Covey, 8th Habit

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Contact Information

• naceda_at_upmc.edu
• www.aging.pitt.edu