Adverse events

The provisions of this Section shall be interpreted consistent with the applicable provisions in the contract between Kaiser Permanente and the Contractor regarding Adverse Events.

An Adverse Event is defined in RCW 70.56.010 as "the list of serious reportable events adopted by the National Quality Forum in 2002, in its consensus report on serious reportable events in health care." Kaiser Permanente reserves the right to update this list as subsequent changes are made by the National Quality Forum. An adverse event can also be called or referred to as a "never event."

Some examples of Adverse Events:

Surgical or invasive procedure events

• Surgery or other invasive procedure performed on the wrong site.
• Surgery or other invasive procedure performed on the wrong patient.
• Wrong surgical or other invasive procedure performed on a patient.
• Unintended retention of a foreign object in a patient after surgery or other invasive procedure.
• Intraoperative or immediately postoperative/postprocedure death in an ASA Class 1 patient.

Product or device events

• Patient death or serious injury associated with the use of contaminated drugs, devices, or biologics provided by the healthcare setting.
• 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.
• Patient death or serious injury associated with intravascular air embolism that occurs while being cared for in a healthcare setting.

Patient protection events

• Discharge or release of a patient/resident of any age, who is unable to make decisions, to other than an authorized person.
• Patient death or serious injury associated with patient elopement (disappearance).
• Patient suicide, attempted suicide, or self-harm that results in serious injury, while being cared for in a healthcare setting.

Care management events

• 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).
• Patient death or serious injury associated with unsafe administration of blood products.
• Maternal death or serious injury associated with labor or delivery in a low-risk pregnancy while being cared for in a healthcare setting.
• Death or serious injury of a neonate associated with labor or delivery in a low-risk pregnancy.
• Patient death or serious injury associated with a fall while being cared for in a healthcare setting.
• Any Stage 3, Stage 4, and unstageable pressure ulcers acquired after admission/presentation to a healthcare setting.
• Artificial insemination with the wrong donor sperm or wrong egg.
• Patient death or serious injury resulting from the irretrievable loss of an irreplaceable biological specimen.
• Patient death or serious injury resulting from failure to follow up or communicate laboratory, pathology, or radiology test results.

Environmental events

• Patient or staff death or serious injury associated with an electric shock in the course of a patient care process in a healthcare setting.
• 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.
• 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.
• Patient death or serious injury associated with the use of physical restraints or bedrails while being cared for in a healthcare setting.

Radiologic events

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

Potential criminal events

• Any instance of care ordered by or provided by someone impersonating a physician, nurse, pharmacist, or other licensed healthcare provider.
• Abduction of a patient/resident of any age.
• Se class="list"xual abuse/assault on a patient or staff member within or on the grounds of a healthcare setting.
• 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.

If an adverse event occurs, the health care facility is required to report the event to the Washington State Department of Health in accordance with RCW 70.56.020. The health care facility should apologize to the patient, report the event, investigate the event, report its underlying cause, take corrective action to prevent similar events and waive costs directly related to the event.

In the instance of an adverse event the health care facility agrees that it will not charge the patient or Kaiser Permanente for any and all care associated with the event, including complications which are the result of the event.

Inpatient claims

Hospitals are required to submit a no-pay claim (TOB 110) when the erroneous surgery related to the Adverse Event is reported. If there are covered services/procedures provided during the same stay as the erroneous surgery, hospitals are then required to submit two claims:

• One claim with covered service(s)/procedure(s) unrelated to the erroneous surgery(s) on a Type of Bill (TOB) 11X (with the exception of 110), and,
• The other claim with the non-covered service(s)/procedure(s) related to the erroneous surgery(s) on a TOB 110 (no-pay claim). The claim for the non-covered services will be denied. Also, the non-covered TOB 110 must have one of the following ICD-9 diagnosis codes reported in diagnosis position 2-9:

1. E876.5—Performance of wrong operation (procedure) on correct patient (existing code).
2. E876.6—Performance of operation (procedure) on patient not scheduled for surgery.
3. E876.7—Performance of correct operation (procedure) on wrong side/body part.

For discharges on or after October 1, 2009, hospitals will refer to MLN Matters Number MM6634 on the CMS Web site for how to submit an erroneous surgery claim.

Outpatient, mbulatory Surgical Centers (ASCs), other appropriate bill types, and practitioner claims

Hospital outpatient departments, ASCs, practitioners and those submitting other appropriate TOBs are required to append one of the following applicable modifiers to all lines related to the erroneous surgery(s):

• PA–Surgery Wrong Body Part.
• PB–Surgery Wrong Patient.
• PC–Wrong Surgery on Patient.

Kaiser Permanente will suspend claims with surgical errors identified by one of the above HCPCS modifiers.

Kaiser Permanente will create and maintain a list that includes the beneficiary health information code and the surgical error date of service. Each new surgical error occurrence will be added to the list and all claims for that beneficiary for that date of service will be suspended.

Claim lines submitted with one of the above HCPCS modifiers will be line-item denied.

Related claims

Within five days of receiving a claim for an Adverse Event, Kaiser Permanente will begin to review beneficiary history for related claims as appropriate (both claims already received and processed and those received subsequent to the notification of the adverse event). Also, Kaiser Permanente will review any incoming claims that have the potential to be related. When Kaiser Permanente identifies such claims, it will take appropriate action to deny such claims and to recover any overpayments on claims already processed.

Every thirty days for an eighteen-month period from the date of the adverse event, Kaiser Permanente will continue to review beneficiary history for related claims and take appropriate action as necessary.