In 1998, a group of employers (the Leapfrog Group) came together to discuss how they could use their influence to positively impact the quality and affordability of healthcare. A 1999 report by the Institute of Medicine gave the Leapfrog founders an initial focus: reducing preventable medical mistakes. The report found that up to 98,000 Americans die every year from preventable medical errors made in hospitals. The founders realized that they could take "leaps" forward with their employees, retirees, and families by rewarding hospitals that implement significant improvements in quality and safety. The Leapfrog Group was officially launched in November 2000.
In 2002, the National Quality Forum (NQF), a private organization whose members include the American Medical Association (AMA), created and endorsed a list of "serious reportable events" in reference to medical errors that should never occur in a facility. These 27 events included injuries caused by errors in medical management, errors in surgical management, and errors that occurred as a result of failure to follow standards of care or hospital policies and procedures. Importantly, these 27 events were identified by the NQF as both serious and preventable. The list of events represented a consensus among representatives of all parts of the healthcare system, including physicians, hospitals, and other professional providers; public and private purchasers of healthcare; consumers; accrediting boards; and those involved in healthcare research and/or quality improvement. The list was expanded in 2006 to include a combination of 28 Serious
Reportable Events (SRE) or “Never Events”. The second update of NQF’s SREs presents the results of evaluating the 28 NQF-endorsed SREs, with recommended
modifications, and 12 new events considered under NQF’s Consensus Development
Process (CDP). After evaluation against the threshold criteria of unambiguous,
largely, if not entirely, preventable, and serious, 29 SREs (listed below) are recommended
for endorsement as voluntary consensus standards suitable for public reporting.
The purpose of the NQF-endorsed list of SREs in healthcare is to facilitate uniform and comparable public
reporting to enable systematic learning across healthcare organizations and
systems and to drive systematic national improvements in patient safety based
on what is learned—both about the events and about how to prevent their
recurrence. The SREs were originally envisioned as
a set of events that might form the basis for a national state-based reporting
system, and they continue to serve that purpose. Additionally, they have been
used or adapted by national entities with the goal of illuminating such events
to facilitate learning and improvement.
Using the criteria developed by the NQF, and working with other groups, the Centers for Medicare & Medicaid Services (CMS) issued new Medicare and Medicaid payment and coverage policies to improve safety for hospitalized patients.
In 2007, CMS issued a final rule to end additional payments to hospitals for certain preventable conditions acquired during a hospital stay (i.e., Hospital-Acquired Conditions [HAC]). The CMS rule also prohibits passing these charges on to patients. The CMS selection criteria for HAC and the NQF selection criteria are similar, but not identical. Over time, CMS has published subsequent fiscal year final rules that have expanded the list of selected HACs that have Medicare payment implications. Hospitals are required to submit inpatient hospital charges with a Present on Admission (POA) indicator. POA is defined as a condition that is present at the time the order for inpatient admission occurs.
In 2009, CMS initiated three Medicare National Coverage Determinations (NCD) to address “wrong surgery,” a category of “never events” included in the NQF’s list of Serious Reportable Adverse Events. These three CMS NCDs address coverage for surgery on the wrong body part, surgery on the wrong patient, and wrong surgery performed on a patient.
NEVER EVENT
A Never Event is defined as any of the following:
1. A surgical or other invasive procedure performed in a facility on the wrong body part/wrong site
2. A surgical or other invasive procedure performed in a facility on the wrong patient
3. The wrong surgical or other invasive procedure performed on a patient in a facility
PREVENTABLE SERIOUS ADVERSE EVENT
A Preventable Serious Adverse Event meets all of the following criteria:
- Is reasonably preventable through the use of evidence-based guidelines and/or criteria
- Is within the control of the facility or the providers practicing in the facility
- Is the result of an error made in the facility (i.e., the condition was not present when the patient was admitted to the facility)
- Result in serious or significant harm
- Is clearly, unambiguously, and precisely identified, reportable, and measurable
- Is not Present on Admission (POA)
- Is one of the following conditions that is considered reasonably preventable through the application of evidence-based protocols.
The following are Serious Reportable Events as defined by the NQF:
1. Surgical or Invasive Procedure Events
1a. Surgery or other invasive
procedure performed on the wrong site
1b. Surgery or other invasive
procedure performed on the wrong patient
1c. Wrong surgical or other invasive procedure
performed on a patient
1d. Unintended retention of a
foreign object in a patient after surgery or other invasive procedure
1e. Intraoperative or immediately
postoperative/postprocedure death in an ASA Class 1 patient
2. Product or Device Events
2a. Patient death or serious
injury associated with the use of contaminated drugs, devices, or biologics
provided by the healthcare setting
2b. Patient death or serious
injury associated with the use or function of a device in patient care, in
which the device is used or functions other than as intended
2c. Patient death or serious
injury associated with intravascular air embolism that occurs while being cared
for in a healthcare setting
3. Patient Protection Events
3a. Discharge or release of a
patient/resident of any age, who is unable to make decisions, to other than an
authorized person
3b. Patient death or serious
injury associated with patient elopement (disappearance)
3c. Patient suicide, attempted
suicide, or self-harm that results in serious injury, while being cared for in
a healthcare setting
4. Care Management Events
4a. Patient death or serious
injury associated with a medication error (e.g., errors involving the wrong
drug, wrong dose, wrong patient, wrong time, wrong rate, wrong preparation, or
wrong route of administration)
4b. Patient death or serious
injury associated with unsafe administration of blood products
4c. Maternal death or serious
injury associated with labor or delivery in a low-risk pregnancy while being
cared for in a healthcare setting
4d. Death or serious injury of a
neonate associated with labor or delivery in a low-risk pregnancy
4e. Patient death or serious
injury associated with a fall while being cared for in a healthcare setting
4f. Any Stage 3, Stage 4, and
unstageable pressure ulcers acquired after admission/presentation to a
healthcare setting
4g. Artificial insemination with
the wrong donor sperm or wrong egg
4h. Patient death or serious
injury resulting from the irretrievable loss of an irreplaceable biological
specimen
4i. Patient death or serious
injury resulting from failure to follow-up or communicate laboratory,
pathology, or radiology test results
5. Environmental Events
5a. Patient or staff death or
serious injury associated with an electric shock in the course of a patient
care process in a healthcare setting
5b. Any incident in which systems
designated for oxygen or other gas to be delivered to a patient contains no
gas, the wrong gas, or are contaminated by toxic substances
5c. Patient or staff death or
serious injury associated with a burn incurred from any source in the course of
a patient care process in a healthcare setting
5d. Patient death or serious
injury associated with the use of physical restraints or bedrails while being
cared for in a healthcare setting
6. Radiologic Events
6a. Death or serious injury of a
patient or staff associated with the introduction of a metallic object into the
MRI area
7. Potential Criminal Events
7a. Any instance of care ordered
by or provided by someone impersonating a physician, nurse, pharmacist, or
other licensed healthcare provider
7b. Abduction of a
patient/resident of any age
7c. Sexual abuse/assault on a
patient or staff member within or on the grounds of a healthcare setting
7d. Death or serious injury of a
patient or staff member resulting from a physical assault (i.e., battery) that
occurs within or on the grounds of a healthcare setting
PRESENT ON ADMISSION
All claims involving inpatient admissions to general acute care hospitals or other facilities that are subject to a law or regulation mandating collection of present on admission information.
Present on admission is defined as present at the time the order for inpatient admission occurs, conditions that develop during an outpatient encounter, including emergency department, observation, or outpatient surgery, are considered as present on admission.
The following list of POA indicators are applicable to both the primary and secondary diagnosis codes as well as the external cause of injury codes:
For purposes of this policy, a facility is defined as a short-term or long-term, duly licensed acute care, general hospital, or a duly licensed pediatric or cancer hospital, an ambulatory surgical center (ASC), or a skilled nursing facility.
For purposes of this policy, a facility does not include any of the following: nursing home; custodial care home; health resort, spa or sanitarium; place for rest; place for aged; place for treatment of mental illness; place for treatment of alcohol or drug abuse; place for treatment of pulmonary tuberculosis; or place for provision of hospice care.
For purposes of this policy, professional providers and other qualified healthcare professionals are those who are involved in surgical procedures including, but not limited to: operating surgeon, surgical assistant, and anesthesiologist.
MANDATES
PENNSYLVANIA HOUSE BILL NUMBER 84
Effective August 9, 2009, Pennsylvania House Bill Number 84, the Preventable Serious Adverse Events Act, defines language associated with preventable serious adverse events. This bill states: "A healthcare provider may not knowingly seek payment from a health payer or patient for a preventable serious adverse event or for any services required to correct or treat the problem created by a preventable serious adverse event when that event occurred under their control."
NEW JERSEY ACT NO. 2471
Effective February 27, 2010, New Jersey Act No. 2471 prohibits hospitals from seeking payment for costs associated with conditions or events that are subject to the hospital-acquired condition payment provisions of the Medicare program, as regulated by the Centers for Medicare & Medicaid Services (CMS).
For additional state mandate information, refer to Attachments A and B of this policy.
