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PMDA Public Policy Committee Report
2007-2008Thomas Lawrence, MD
David A. Nace, MD, MPH
Co-Chairs, PMDA Public Policy [email protected]
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“I’m 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
1. Comprehensive Infection Control Plan
2. Active Surveillance System
3. Electronic Reporting of HCAI
4. Incentive Payments
5. Surcharge
6. 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 HCAI’s 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:1. Occurs in a patient in a health care setting
2. Was not present or incubating at the time of admission, unless the infection was related to a previous admission to the same setting.
3. 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– > 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 (> 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 > 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=188&bc=0&c=38963
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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
Regulations:Infection 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 1996;313:1241-2.
77%
23%
Flu -
Flu +
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
59%28%
0%
50%
100%
Flu Resp Inf
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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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RISE NETWORK - HCW FLU IMMUNIZATION RATES ALL FACILITIES 2007-2008
0%
10%
20%30%
40%
50%
60%
70%80%
90%
100%
A B C D E F G H I J K L M N O P Q
Facility
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Health & Human Services
Late Season Influenza Immunizations
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Late Season Immunizations
National Influenza Vaccination WeekDECEMBER 8-14, 2008
– Provider immunization efforts typically end November
– Flu doesn’t 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 provider’s control to avoid, but that occurs because of an error or other system failure and results in a patient’s 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