PMDA Public Policy Committee Report 2007-2008 Thomas Lawrence, MD David A. Nace, MD, MPH Co-Chairs, PMDA Public Policy Committee [email protected]

PMDA Public Policy Committee Report

2007-2008Thomas Lawrence, MD

David A. Nace, MD, MPH

Co-Chairs, PMDA Public Policy [email protected]

[email protected]

“I’m David Nace and I approved this message”

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”

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

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

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


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


• Culture surveillance processes & policies– Surveillance for the HCAI’s defined in the PA

Bulletin

– Active case finding

– Role of the Infection Preventionist critical


• 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


• 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


• 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


• 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


• 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

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

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

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

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

Penalties

• Failure to report HCAI

• Failure to develop, implement, or comply with a plan

• $1000 / day

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)

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

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.

Reportable Conditions

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

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

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

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

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

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

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

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

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

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

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.

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

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.

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.

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)

F 441-445 Federal Nursing Facility Licensure

Regulations:Infection Control

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))

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

F 441-445

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

Health workers administer flu and pneumonia inoculations at Embarkation Camp in Genicart, France, during the 1918 flu pandemic.

Health & Human Services

Healthcare Worker (HCW) Influenza Immunization Initiative

Healthcare Workers

HCW are at risk for Getting the flu

Personal Safety

HCW are at risk for Giving the flu

Patient Safety

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

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

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.

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

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

Health & Human Services

Late Season Influenza Immunizations

Late Season Immunizations

National Influenza Vaccination WeekDECEMBER 8-14, 2008

– Provider immunization efforts typically end November

– Flu doesn’t end in November or December

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

PA House Bill 2098 Preventable Serious Adverse Events Act

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.


• 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.


• 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


• Passed by House

• Referred to Senate

• Senate session ended before passage

• PMS– Key is in the wording of “preventable serious

adverse events”– Will pass

PMDA PositionHouse Bill 2098

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

• definitions

Leadership

Leadership is communicating to a person, their worth & potential so clearly that they

come to see it in themselves –

Stephen Covey, 8th Habit

Contact Information

• [email protected]

• www.aging.pitt.edu

Documents

PMDA Public Policy Committee Report 2007-2008 Thomas Lawrence, MD David A. Nace, MD, MPH Co-Chairs, PMDA Public Policy Committee [email protected]