The “Never Event”in Patient Safety

David Gourley, MHA, RRT, CPHRM, FAARCDirector of Quality and Outcomes Mgmt.Chilton Medical CenterPompton Plains, New Jersey

Conflict of Interest

I have no real or perceived conflict of interest that relates to this presentation. Any use of brand names

is not in any way meant to be an endorsement of a specific product,

but to merely illustrate a point of emphasis.

ObjectivesLearning objectives for this presentation:•Describe the origin of “never events”•Explain the human and financial impact of never

events• Identify the never events of concern to the RT•Describe the relationship between never events

and hospital acquired conditions

“Never Events”

•Overview of “Never Events”•Criteria for Inclusion as Never Events•Impact of Never Events•Categories of Never Events•Accountability of Healthcare Organizations•CMS Hospital Acquired Conditions•Concept of “Never” •Case Studies

“Never Events”

•What is your knowledge of “Never Events”▫Thoroughly knowledgeable▫Working knowledge▫Some familiarity▫No knowledge

“Never Events”•Spearheaded by IOM report “To Err is

Human”•National Quality Forum established in

2002•Originally 27 serious reportable events,

expanded to 29•Considered “largely preventable”•Have been incorporated by 26 states and

DC into patient safety reporting systems

“Never Events”

•Established to facilitate uniform and comparable public reporting

•Enable systematic learning•Drive national improvements in

patient safety

“Never Events”According to the National Quality Forum:

Never events are “of concern to both the public and healthcare professionals and

providers; clearly identifiable and measurable and of a nature such that the

risk of occurrence is significantly influenced by the policies and procedures of the

healthcare organization”

Criteria for Inclusion as “Never Event”

•Unambiguous•Largely, if not entirely preventable•Serious•Any of the following:

▫Adverse▫Indicative of a problem in

healthcare safety systems▫Important for public credibility or

accountability

Criteria for Inclusion as “Never Event”•Of concern to both the public and

healthcare professionals and providers•Clearly identifiable and measurable•Of a nature such that the risk of

occurrence is significantly influenced by the policies and procedures of the healthcare facility

Impact of Never Events•2 million events annually•90,000 deaths annually•$5.7 billion in added healthcare costs•$29 billion in associated costs (additional

health care expenses, lost work & income, disability)

Categories of “Never Events”

•Surgical or Invasive Procedure Events

•Product or Device Events•Patient Protection Events•Care Management Events•Environmental Events•Radiologic Events•Potential Criminal Events

Surgical or Invasive Procedure Events

•Surgery/other invasive procedure performed on the wrong site

•Surgery/other invasive procedure performed on the wrong patient

•Wrong surgical/other invasive procedure performed on a patient

•Unintended retention of a foreign object

• Intraoperative or immediate post-op/procedure death in ASA Class 1 patient

Product or Device Events•Patient death/serious injury associated

with contaminated drugs, devices, or biologics

•Patient death/serious injury associated with use or function of device

•Patient death/serious injury associated with intravascular air embolism

Patient Protection Events

•Discharge or release of patient who is unable to make decisions, to other than authorized person

•Patient death/serious injury associated with patient elopement

•Patient suicide, attempted suicide, or self harm that results in serious injury

Care Management Events• Patient death/serious injury associated

with medication error (wrong drug, dose, patient, time, rate, preparation, or route)

• Patient death/serious injury associated with administration of blood products

• Maternal death/serious injury associated with labor or delivery in low-risk pregnancy

• Death/serious injury of neonate associated with labor or delivery in low-risk pregnancy

Care Management Events (cont.)• Patient death/serious injury associated

with a fall• Stage 3 or 4, and unstageable pressure

ulcers acquired after admission• Artificial insemination with wrong donor

sperm or egg• Patient death/serious injury from loss of

irreplaceable biological specimen• Patient death/serious injury from failure

to f/u or communicate lab, pathology, or radiology results

Environmental Events•Patient or staff death/serious injury

associated with electric shock in the course of pt. care

•Medical gas mix-up (no gas, wrong gas, contaminated by toxic substances)

•Patient or staff death/serious injury associated with burn from any source in the course of pt. care

•Patient death/serious injury associated with physical restraints or bedrails

Radiologic Events

•Death/serious injury of a patient or staff associated with introduction of a metallic object into the MRI area

July 31, 2001

Boy, 6, Dies Of Skull Injury During M.R.I.

Potential Criminal Events•Any care ordered by/provided by

someone impersonating a physician, nurse, pharmacist, or other licensed healthcare provider

•Abduction of a patient of any age•Sexual abuse/assault on a patient or

staff member•Death/serious injury of patient or

staff member from physical assault

Accountability of Healthcare Organizations

•Diligent effort to discover vulnerabilities that could lead to adverse events

•Focused review and analysis of events▫Determine causal and

contributing factors•Applying what is learned to

continuous quality improvement•Public reporting of adverse

events

State Reporting of Adverse Events

•26 states and District of Columbia have enacted reporting systems for adverse events

•State defined lists: FL, GA, KS, MD, NE, NV, OH, PA, RI, SC, SD, TN, UT

•Modified NQF lists: CA, CO, CT, DC, MA, NJ, NY, OR, WA

•NQF SREs: IL, IN, MN, NH, VT

2011 Update

•Ensure continued currency and appropriateness

•Ensure events are appropriate for continued public reporting

•Provide guidance to new reporters•Clarifying events to be reported by

other settings:▫Office-based practices▫Ambulatory surgical centers▫Skilled nursing facilities

CMS Hospital Acquired Conditions

•CMS identified 11 conditions (HAC’s)

•Beginning October 1, 2008, no longer pays hospitals for increased costs resulting from HAC’s

•HAC’s overlaps “Never Events”•Intent to improve quality of care•Implements “pay for

performance”•Adopted by some third party

payors

CMS Hospital Acquired Conditions

HOSPITAL ACQUIRED CONDITIONS (HAC’s)

Foreign object retained after surgery

Blood incompatibility

Air embolism

Stage 3 or 4 pressure ulcers

Falls and trauma (fracture, dislocation, intracranial injury, crashing injury, burn, electric shock

Catheter-associated urinary tract infections

Vascular catheter-associated infections

Manifestations of poor glycemic control

Surgical site infections following CABG

Surgical site infections following certain orthopedic procedures (spine, neck, shoulder)

Surgical site infections following bariatric surgery

DVT or PE following certain orthopedic procedures (total hip or knee)

CMS Hospital Acquired ConditionsCONDITION # REPORTED

ANNUAL EVENTS

Pressure Ulcers 257,412

Falls/Trauma 193,566

Central Line Associated Bloodstream Infections (CLABSI)

16,060

Catheter Associated Urinary Tract Infections (CAUTI)

12,185

Foreign Object Retained after Surgery 750

Surgical Site Infections 747

Air Embolism 57

Blood Incompatibility 24

Concept of “Never”• Is the term “never events” a

misnomer•Are “never events” truly preventable?• Is “never” an expectation or a goal?•Do issues such as comorbidities, age,

gender, hospital variables affect outcomes

•Philosophy of “Getting to Zero”•Adopting principles of High

Reliability Organizations (HRO)

Never Events

Have you ever been involved in one????

Yes No

Case study # 1

•78 year old female•End-stage COPD•Chronic ventilatory failure•Refusing intubation•Using NIPPV 18 – 20 hours per day•On day 7, pressure ulcer noticed on

bridge of nose by Respiratory Therapist

•Continues on NIPPV•Pressure ulcer progresses to stage 3

“Never Event” Assessment•Have you ever been involved in a

similar event? YES NO•Was it handled as a never event at

your facility? YES NO•Were changes implemented to

prevent similar events in the future?

YES NO•Have they been successful in

preventing future events?YES NO

Case Study # 2•62 year old male •Brought to ED with SOB

and chest pain•History of CHF•EMS crew had patient on NRB mask

@ 15 LPM•Patient experiences cardiac arrest

and is not successfully resuscitated•RT identifies that NRB mask was

connected to compressed air, not oxygen

“Never Event” Assessment

•Have you ever been involved in a similar event? YES NO

•Was it handled as a never event at your facility? YES NO

•Were changes implemented to prevent similar events in the future?

YES NO•Have they been successful in

preventing future events?YES NO

Case study # 3• 50 year old healthy female• Hysterectomy performed on Tuesday

afternoon• Wednesday afternoon, patient

experiencing moderate abdominal pain, fever, and vomiting

• Patient deteriorates into ventilatory failure

• Brought back to OR, perforated bowel identified

• Patient experiences cardiac arrest and is not successfully resuscitated

“Never Event” Assessment•Have you ever been involved in a

similar event? YES NO•Was it handled as a never event at

your facility? YES NO•Were changes implemented to

prevent similar events in the future?YES NO

•Have they been successful in preventing future events?

YES NO

Case study # 4

• 28 year old female • Just returned home from

airplane flight from Tokyo• Brought to ED with chest pain and SOB• ABG performed: pH – 7.45, PCO2 –

29.8, PO2 – 43.8• RT distracted by Code Blue, ABG never

reported• Patient experiences cardiac arrest, is

resuscitated and dx. of pulmonary emboli

“Never Event” Assessment

•Have you ever been involved in a similar event? YES NO

•Was it handled as a never event at your facility? YES NO

•Were changes implemented to prevent similar events in the future?

YES NO•Have they been successful in

preventing future events?YES NO

Case study # 5•66 year old male•Admitted with shortness of breath•Dx. with Legionella pneumophila•On third day, condition

deteriorates, Rapid Response Team called

•RT prepares to intubate, laryngoscope not functioning

•8 minute delay in intubation•Patient experiences cardiac arrest

and expires

“Never Event” Assessment

•Have you ever been involved in a similar event? YES NO

•Was it handled as a never event at your facility? YES NO

•Were changes implemented to prevent similar events in the future?

YES NO•Have they been successful in

preventing future events?YES NO

“Never Events” •CMS Never Events, rL Solutions,

October 2008•The Leapfrog Group, Never Events

Fact Sheet, March 2008•Serious Reportable Events in

Healthcare – 2011 Update, National Quality Forum

•Serious Reportable Events, Transparency, accountability, critical in reducing medical errors and harm, National Quality Forum

“Never Events”