Legal Issues in Infection Prevention

Tammy Lundstrom, MD, JD

SVP, Chief Medical Officer

Premier Health

Objectives

• Define current legal landscape in relationship to healthcare-associated infections

• Identify issues related to infection prevention program legal risks

• Discuss methods to mitigate risk for a high performing infection prevention program

Elements of a Typical Malpractice Case

• Plaintiff (patient) must prove:– Existing duty (standard of care)

• National standard

• Duty to provide infection-free environment

– Breach of Duty• Didn’t follow national/local standard of care

• Didn’t follow own policy

– Causation (but for…..)• Difficult to prove in healthcare associated infection case

– injury

An Infection, Unnoticed, Turns Unstoppable

• NYT July 11, 2012

Rory Staunton taking his first flying lesson in 2011.

Infections and Medical Malpractice

• Most involve failure to diagnose or treat effectively

• Few cases related to lapses in infection prevention other than contaminated products, gross lapses in aseptic technique

• Causation (but for…..) presents the biggest hurdle to HAI liability cases

Important Considerations

• Patient risk factors– Severity of illness or injury for which the patient was admitted– Immune status– Duration of hospital stay

• Organizational risk factors– Cleanliness of hospital– Water and heating, ventilation, and air conditioning (HVAC)

filtration systems– Concentration of patients

• Iatrogenic risk factors– Individual activities of physicians and staff (hand hygiene, use of

antibiotics, level of care during invasive procedures)

Findlaw article http://knowledgebase.findlaw.com Rheingold 4/21/12

Potential Use of Publicly Reported Data?

• Can it be used by Plaintiff’s counsel

– Attempt to discredit

– ? Evidence of poor hospital quality

MORE TO COME………

Additional Concerns

• “Waiver” or Peer Review protections

– State Peer review and Quality statutes protect quality and peer review actions from discovery requests

– Is voluntary reporting of aggregate data enough to constitute waiver?

To date no litigation attempting to use public rates against defendant hospitals

Root Cause Analysis

• West Virginia

• Root cause analysis reported to the Joint Commission

• Court held hospital internal investigation was not discoverable under Peer Review/Quality protection statutes

Current Statutes

• MO:

“any information disclosed to the public……..may NOT be used to establish a standard of care in a private civil action”

• Federal Protections for data reported to AHRQ certified Patient Safety Organizations (PSO)

– NOTE: Affordable Care Act requires hospital participation in PSO by Jan 1, 2015 in order to accept patients who got their insurance on federal exchanges

(Un)intended Consequences of Public Reporting of Quality Data

• Positive

– Allows selection of high quality providers by patients/referring physicians/purchasers

– Induce physicians/providers to improve quality

– Enhance accountability of healthcare providers

JAMA Vol. 293 (10); 1239-1244, March 2005

Unintended Consequences of Public Reporting

• Negative:

– Induce physicians/hospitals to deny care or procedures to sicker patients

– Induce inappropriate utilization of care (ex: everyone visiting ED gets CAP antibiotics so that 4 hour timing is not missed)

– Pressure on Infection Prevention to apply definitions so as NOT to call it an HAI

The Science Of Public Reporting

The Problem for Consumers

• Different “quality” rankings

• Different time frames

• Different metrics

• Different displays

How can I know?

The Joint Commission

2012 Hospital and Physician Professional Liability Benchmark Analysis

• 29% of all claims are associated with healthcare acquired conditions: HAI, injuries, medication errors, objects left behind after surgery, pressure ulcers

• Up from 24% in 2010

• Pediatrics and academic medial centers: fewer claims but higher severity

ASHRM: American Society for Healthcare Risk Management

Dozens of Law Firms “specializing” in:

Google of Infection and malpractice

• MRSA

• KPC

• CRE

• C. difficile

• CLABSI

• Orthopedics SSI

• Fungal meningitis

Cases

• No comprehensive data base for tort (malpractice) law

• Cases not often published

• Settlement frequent: often with non-disclosure agreements

• 9 MRSA cases

– Earliest 2001

– Defendants won 8/9

Cases-Philadelphia

• Survey of attorneys, risk mangers, hospitals 1996-2002

• 154 cases

– Most orthopedic (69), general surgery (20), or cardiac (20)

– MRSA 45 cases

– 27 settled

– 27 withdrawn

AJIC McGucken 2005

Cases-Plaintiff must prove

• Breach of duty: hospital breached standard of care (local/national)

• Causation– Not caused by patient or family actions

– State peer review/quality protection statutes make it difficult for plaintiff to get information beyond hospital record

– Informed consent: assumption of risk

• Damages/injury

Cases- Vars vs Palo Verde Hospital

• Abdominal hysterectomy given post operative antibiotics

• Incision grew MRSA, next day multiple organisms

• Court found for hospital: infection could have originated from patient’s own flora

California 2005

Cases- Riggs vs Ruby Memorial Hospital

• Young woman following ACL reconstruction

• Femoral tunnel grew Serratia marscesens

• Alleged hospital had outbreak at the time she had surgery but failed to inform her preoperatively

• Infection Control failed to prevent and control infections

• $1 million in pain and suffering

West Virginia 2006

Cases: Missouri MRSA

• 69 y/o with heart attack: IV inserted by EMS

• IV inserted by EMS not changed when patient arrived at the facility (CDC guidelines)

• Patient underwent pacemaker insertion with reddened IV site (surgery should have been delayed- CDC guidelines)

• MRSA infection of pacemaker, patient lost foot and kidney

• $2.58 million verdict

Infection Prevention Program

• Risk– -reporting mandates makes it easier to compare facility

results

• Mitigation– CMS conditions of participation require that infection

prevention be included as part of Quality Assessment/Performance Improvement (QAPI) program

– Wrapping the program into QAPI helps assure quality protection for minutes/data

– Label program documents with state/federal quality reporting statute language (obtain from risk management or legal)

Infection Prevention Program

• Risk

– Not following standard of care (local/state/national)

• Mitigation

– Utilize evidence based guidelines from CDC, SHEA, APIC, AORN, other professional societies as appropriate

– Utilize and reference guidelines for your policies and procedures

Infection Prevention Program

• Risk– Not following standard of care: policies too specific

and detailed

– Easiest path to prove breach of standard of care is not following your own policies!

• Mitigation– Involve frontline staff in creation of policies (but

follow evidence), include workflow considerations

– Adhere to policies (audit, audit, audit)

– Separate policy from procedure/work instructions

More on Policies

• Considerations for audits– Focus on adherence to : hand hygiene, contact and

airborne precautions, environmental cleaning, aseptic technique in procedural areas and during device maintenance

– Focus on documentation of “present on admission”

• Considerations for policies– Avoid absolute language (always/never)– Document when deviate (ex: femoral line); collaborate

with coders, clinical documentation improvement– Avoid “more is better” in policies

Additional Mitigation Strategies

• Utilize risk management/legal in policy review

• Involve medical records, quality, coding, IT in documentation improvements

• Present data frequently to medical executive committee, Boards to gain further support for improvement efforts

• Unit based “safety coaches”, physician champions

• Involve executive when they are performing required rounding

Additional Mitigation Strategies:Infection Prevention is a Team Sport

• Daily safety huddles

• Tell patient stories

• Equate statistics to people/harm avoidance (the face of harm)

• 4:1 positive feedback

70%

45%

20% 10%

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30%

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Clinical Process of Care

Patient Experience of Care

Outcomes

Efficiency

2013 2014 2015 20161

Value Based PurchasingProgram Expansion Promises Performance Challenges

New Healthcare Associated Conditions Penalty

Starting FY 2015

•Section 3008 of the Affordable Care Act (ACA) requires Secretary, Department of Health and Human Services to implement a Healthcare Associated Condition (HAC) payment adjustment

•Hospitals performing in lowest quartile of HAC's will face 1 percent reduction in all payments (including IME, DSH)

•HAC reductions will be applied after adjustments for the VBP and the readmissions programs

•This HAC program is in addition to the previous HAC Non-Payment Program [No increase in payment for healthcare associated conditions not present on admission (i.e. falls, pressure ulcers)]

Changes to Readmissions Program

• Maximum penalty increased to 2%• Incorporation of planned readmissions algorithm

– Applied to Acute Myocardial Infarction, Heart Failure, and Pneumonia measure starting FY 2014

• As proposed, CMS will not count unplanned readmissions that follow a planned readmission if it is within 30 days of the initial index admission

• New Measures:– Chronic Obstructive Pulmonary Disease– Elective Total Hip Arthroplasty/Total Knee Arthroplasty

• May be included in Moody’s Bond Rating

It is not the strongest of the species that survives, nor the most intelligent that survives. It is the one that is most adaptable to change.

~Charles Darwin