1 Updates in Patient Safety Helen Burstin, MD, MPH Senior Vice President, Performance Measures National Quality Forum Academy Health June 8, 2008.

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Updates in Patient Safety

Helen Burstin, MD, MPH Senior Vice President, Performance

MeasuresNational Quality Forum

Academy Health June 8, 2008

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NQF Mission

• To improve the quality of American healthcare by setting national priorities and goals for performance improvement,

• endorsing national consensus standards for measuring and publicly reporting on performance, and

• promoting the attainment of national goals through education and outreach programs.

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NTTAA

National Technology and Transfer Advancement of Act of 1995 (NTTAA)

Defines the five key attributes of a “voluntary consensus standards-setting body” (i.e., openness, balance of interest, due process, consensus, and an appeals process)

Obligates federal government to adopt voluntary consensus standards (when the government is adopting standards)

Encourages federal government to participate in setting voluntary consensus standards

National Framework for Quality and Cost Transparency for High-Value CareNQF National Priorities Partners*

NCQA The Joint Commission AMA PCPI Medical Societies Medical Specialty Boards CMS AHRQ Others**

NQF

QASC Quality Alliances Joint Commission NCQA Medical Specialty Boards

QASC Regional Collaboratives RHIOs/HIEs CMS States Health Data Stewards

ConsumerOutcomes

High Quality Equitable Affordable

Patient-Centered

Set national priorities and goals to drive improvement and affordability

Develop and test evidence-based measures

Endorse and maintain measures and incorporate specifications into EHRs

Develop coordinated and streamlined implementation strategies: prioritization, timelines, and process solutions

Aggregate data and pilot test and validate standard performance information

Generate public reports on quality and cost

Regional Collaboratives Fed/State Govt. Health Plans Others

QIOs Regional Collaboratives Providers Oversight Organizations Employers Health Plans

Continuously evaluate health and health care

AHRQ Foundations Other

Improve quality and reduce waste

Establish effective public policies, payment policies, and consumer incentives to reward or foster better performance

Fed/State Govt Health Plans Employers Consumers Providers

DRAFT - Quality Alliance Steering Committee

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Patient Safety 2008

• IOM “To Err is Human” – 44,000 to 98,000 Americans die each year from preventable medical errors

• Little progress to date - measures of patient safety showed an average annual improvement of just 1 percent (NHQR 2007)

• Unclear impact of Patient Safety and Quality Improvement Act and emerging Patient Safety Organizations (PSOs)

• Growing movement toward public reporting and non-payment for “never events”

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Progress?

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NQF Roles in Patient Safety

• Serious reportable events (including linkage to “no pay” events)

• Cross-cutting patient safety measures• Safe practices update• Common data formats for patient safety • National priorities and goal setting• EHRs and Decision Support

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NQF Serious Reportable Events

• Serious reportable events - serious, largely preventable, and of concern to both the public and healthcare providers – 28 serious reportable events:

• Care management events• Surgical events• Product or device errors• Environmental events• Patient protection

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CMS Policy on Never Events

• Beginning in FY 2009, cases with these conditions would not be paid at a higher rate unless they were present on admission.

• Medicare will no longer pay for the additional costs of certain preventable conditions (including certain infections) acquired in the hospital.

• The rule identifies eight conditions, including three serious preventable events (sometimes called “never events”) that meet the statutory criteria.

• CMS will work to add an additional 3 conditions to the list next year.

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CMS Never Events

• Bloodstream infections from using catheters• Objects left in a patient during surgery*• Urinary tract infections from catheters• Air embolism, an air bubble in a blood

vessel*• An infection after heart surgery called

mediastinitis• Blood incompatibility, giving a dangerously

wrong blood type*• Bed sores, or pressure ulcers • Falls

* NQF Serious Reportable Event

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Proposed CMSNever Events

• Surgical site infections following certain elective procedures

• Legionnaires’ disease • Extreme blood sugar derangement • Iatrogenic pneumothorax • Delirium • Ventilator-associated pneumonia • DVT/PE • Staphylococcus aureus septicemia • Clostridium difficile associated disease

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Leapfrog Policy on Never Events

• Hospitals commit to four actions if any never event* occurs within their facility:

1) apologize to the patient2) report the event3) perform a root cause analysis, and 4) waive costs directly related to the event.

* Includes all 28 NQF SREs

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State-level Never Events

• In 2003, Minnesota became the first state to pass a never-events law that required the reporting of every never-event occurrence.

• New Jersey enacted a law requiring hospitals to report serious, preventable adverse events to the state and to patients’ families

• Connecticut adopted a mix of 36 NQF and state-specific reportable events for hospitals and outpatient surgical facilities. 

• An Illinois law passed in 2005 will require hospitals and ambulatory surgery centers to report 24 “never events” beginning in 2008.  

• Five other states, California, Connecticut, Illinois, Indiana and New Jersey, also have passed similar reporting laws or policies.

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AHRQ Patient Safety Indicators

• Death in low-mortality DRGs (PSI 12)• Failure to rescue (PSI 4) • Foreign body left in during procedure (PSI 5 and

21) *• Complications of anesthesia (PSI 1) *• Selected infections due to medical care (PSI 7 and

23) *• latrogenic pneumothorax (PSI 6 and 22) • Postoperative pulmonary embolism or DVT (PSI

12) • Postoperative hemorrhage or hematoma (PSI 9

and 27) • Postoperative physiologic and metabolic

derangements (PSI 10)

* NQF Serious Reportable Events

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AHRQ Patient Safety Indicators

• Postoperative respiratory failure (PSI 11)• Postoperative hip fracture (PSI 8)• Postoperative sepsis (PSI 13) • Postoperative wound dehiscence (PSI 14 and 24)• Accidental puncture and laceration (PSI 15 & 25)

• Transfusion reaction (PSI 16 & 26) *• Decubitus ulcer (PSI 3) *• Obstetric trauma (PSIs 18-20) • Birth trauma -- injury to neonate (PSI 17)

* NQF Serious Reportable Events

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Safe Practices Update

• Focus on review and maintenance of existing practices based on emerging evidence base– Steering committee: chaired by Charles

Denham (TMIT) and Greg Meyer (MGH)– Additional practices under consideration for

high risk safety areas (including “no pay” events)

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Criteria for Inclusion: Safe Practices

• Specificity. The practice must be a clearly and precisely defined process.

• Benefit. If the practice were more widely utilized, it would save lives endangered by health care delivery... or reduce the likelihood of a serious reportable event.

• Evidence of effectiveness. There must be clear evidence that the practice would be effective in reducing patient safety events. – research studies– experiential data – research findings or experiential data from non-healthcare

industries that should be substantially transferable

• Generalizability• Readiness

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Safe Practices with Expected Changes

• SP 4: Disclosure • SP 14: Medication Reconciliation • SP 19: Prevention of Aspiration and VAP • SP 21: Surgical Site Prevention• SP 23: Influenza Prevention • SP 28: DVT/VTE Prevention • SP 29: Anticoagulation Therapy • SP 30: Contrast Media Induced Renal

Failure Prevention

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New Safe Practices under Consideration

• Hand Offs – Handovers• Second Patient• Organ Donor-ship• Urinary Tract Infection• MRSA MDRO• Pediatric Imaging• Falls• Hyperglycemia• Restraints• Reliable surgical care

Safe Practice/Safety Objective

The Problem (Narrative)

Additional Specifications

Care Settings/ Considerations

Prevent CAUTIs by implementing catheter use, insertion, and maintenance practices.

UTI is the most common HAI; 80% attributable to an indwelling urethral catheter

12-16% of hospital inpatients have a urinary catheter during admission

Daily risk of urinary infection 3% to 7% with indwelling urethral catheter

Provide and implement written guidelines for catheter use, insertion, and maintenance

Use appropriate technique for catheter insertion

Ensure appropriate management of indwelling catheters

All care settings Pediatric taskforce to review

Example Implementation

Measures New Horizons/ Research

Harmonization Partners

Align with IDSA/SHEA paper: best practice section

NQF endorsed measures

CDC definition-rate measure NHSN

Use of antiseptic solution versus sterile saline for meatal cleaning prior to catheter insertion

Use of antimicrobial-coated catheters for selected patients at high risk of infection.

TJC CMS IDSA SHEA CDC

Proposed New Practice: Catheter Associated Urinary Tract Infections

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Patient Safety Data and Improvement Act 2005

• Provides needed legal protections to specially designated Patient Safety Organizations (PSOs) to collect and analyze patient-level information

• Allows PSOs to analyze patient safety data (including patient safety events and “near misses”) to discover important quality improvement strategies.

• Authorizes the Secretary to create and maintain a network of patient safety databases– AHRQ has been charged with developing

the common data formats needed for patient safety event reporting and utilization by the PSOs

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Patient Safety Data

• Common Data Formats:– NQF has been tasked with development of a

plan for multi-stakeholder public comment and collation of comments on the common formats • NQF will convene a Common Formats Expert

Panel to develop criteria for evaluating feedback on the common formats;

• review the organized and triaged comments received in response to NQF’s activation of the plan for public comment; and

• provide input on the proposed common formats and suggestions for improvement to AHRQ.

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NQF Strategic Directions

• We should measure what is important to achieving the best outcomes for patients and populations

• NQF Measurement Framework: promote shared accountability and measurement across patient-focused episodes of care: – Outcome measures – Appropriateness measures – Cost/resource use measures coupled with quality

measures.

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Episode Framework: Acute MI

Getting BetterLiving w/ Illness/Disability (T1)

Coping w/ End of Life (T2)Staying Healthy

Post Acute/Rehabilitation Phase

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Episode begins – onset of symptoms

Post AMI Trajectory 2 (T2)Adult with multiple co-morbidities

Focus on:• Quality of Life• Functional Status• 20 Prevention Strategies• Advanced Care Planning• Advanced Directives• Palliative Care/Symptom Control

Assessment ofPreferences

AcutePhase

PHASE 1

PHASE 2 PHASE 3 PHASE 4

Episode ends – 1 year post AMI

20 Prevention(CAD with prior AMI)Advanced Care Planning

Population at Risk

10 Prevention (no known CAD)

20 Prevention (CAD no prior AMI)

Post AMI Trajectory 1 (T1)Relatively healthy adult

Focus on:• Quality of Life• Functional Status• 20 Prevention Strategies• Rehabilitation• Advanced care planning

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Strategic Issues (1)

• Driving toward high performance– Stakeholders have expressed concern with

multiple process measures too far removed from desired action that drive attention towards care of single accountable entity – rather than system-level improvement

• Shifting toward composite measures– Potential advantages of composite measures:

• More understandable to patients and consumers

• Reflects the comprehensive nature of care and potentially more patient centric

• More oriented toward outcomes improvement

• Drives multi-faceted improvement strategies

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Strategic Issues (2)

• Moving toward outcomes measurement– Growing numbers of measures of morbidity and

mortality for certain conditions (e.g., CHF)– Very limited set of measures that address

functional status, health-related quality of life, and shared decision-making

• Measure disparities in all we do– Identify measures that are disparities-sensitive

and routinely stratify quality data– Outlining a framework for collecting race,

ethnicity, primary language, and socioeconomic status data in an efficient, effective, patient-centered manner

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National Priorities Partners

• Establish national priorities and goals for performance measurement and public reporting

• Focus measurement and improvement efforts on achievement of these goals

• Multi-stakeholder Committee with representation from 27 leadership organizations

• Co-chairs– Don Berwick, IHI– Peggy O’Kane, NCQA

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Preliminary Priority Areas

• Healthcare Associated Infections* – Composite measure of infection rates in

high risk areas

• Avoidable Harms* – Hospital-level mortality rates– Harmonization/global measurement across

serious adverse events

• Continuity of Care* – Care coordination– Medication reconciliation

• Patient/family engagement – Patient activation & shared decision-making

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Preliminary Priority Areas• Overuse

– Identify top 10 areas of overuse in healthcare• Population health

– Composites of key preventive services and healthy lifestyle behaviors

• End of life/palliative care – Composite of symptom management/HRQOL – Overutilization of hospital, ED, chemotherapy

• Reliable and effective care management of chronic/acute patient-focused episodes– Frameworks completed for AMI and low back pain,

ongoing work on cancer and diabetes

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Hospital-level SSI infection rate

Composite measure for HAIs

30-day SSI infection rate – hospital or ambulatory

Change in patient-oriented outcomes, including functional status following HAIs

Standards ready now Urgent to develop

Specific Site of Care

Across the Continuum

Fulfilling Measurement Needs for Priorities

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Shared Data Elements“Sweet Spot”

* Including safety measures

* Including e-Rx

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How do we get there?

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• American Health Information Community (AHIC) Quality Workgroup focused on how Health IT can evolve to effectively support performance measurement. • NQF convened a Health IT Expert Panel

(HITEP) to identify a set of common data elements to be standardized in order to enable automation of a prioritized set of measures through EHRs • HITEP Chair: Paul Tang, MD• Final report to be released shortly

Steps on the path

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Steps on the path

• NQF expects to reconvene HITEP in the near future:– Develop a Quality Data Set that provides the

core data elements needed for quality measurement and clinical decision support built off of clinical guidelines

• Identify and prioritize the needed clinical data standards needed for the Quality Data Set HITSP

– Collect and synthesize clinical workflows within and across healthcare settings

• Review condition-specific examples that would demonstrate the workflow issues involved in data aggregation within a single site of care as well as across an episode of care.

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Not everything that counts can be counted, and not everything

that can be counted counts.

Albert Einstein

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Helen Burstin, MD, MPH Senior Vice President, Performance Measures [email protected]

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