CMS SOM App. H, Tag V634

Medical injuries and medical errors identification.

Interpretive Guidance § 494.110(a)(2)(vi):

The intent of QAPI in addressing medical injuries and identification of medical errors is to

minimize the number of occurrences and limit the number of patients and staff who are adversely

affected by such occurrences. The medical injuries and medical errors that are captured in the

facility’s QAPI program may or may not be related to dialysis-related provisions of care. It is

expected that the facility’s QAPI program addresses those events related to dialysis care and

dialysis facility operations. To maintain an effective QAPI program that aims to achieve

measurable improvement, the facility should have mechanisms in place to identify medical events

within the scope of the dialysis care and services provided.

The facility must compile and the QAPI team must review reports and complaints related to any

patient or staff injuries, and treatment or medication errors. Part of the QAPI activity involves

tracking any injuries or errors to identify the prevalence of occurrences, commonalities, and

causes.

An example of medical injury is a patient fall at the end of their dialysis treatment. Information

to identify any trends and detail the facility's response in terms of risk assessment and

precautions in place to prevent future falls should be available. Similarly, occurrences such as

treatment prescription errors, intradialytic morbidities, and staff needle sticks should be

identified, reviewed and trended.

“Intradialytic morbidities” are any adverse symptoms that occur during the dialysis treatment,

including but not be limited to seizures, chest pain, hypotension and cardiac arrest. Other events

which should be tracked include hospitalizations, deaths, acute allergic-type reactions, blood

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loss >100 ml, and patient transfers by ambulance from the dialysis facility to a hospital

emergency room.

The facility should collect and aggregate data regarding adverse occurrences, and there should

be a mechanism to ensure all adverse events are recorded as soon as possible after they occur.

The QAPI committee should analyze both isolated and repeated events in their review.

The following guidance can be used as guiding definitions for “error”, “medication error”, and

“adverse drug event”. These guidelines are intended for general guidance and should not be

considered binding definitions.

“Error” is defined as the failure of a planned action to be completed as intended (error of

execution) or the use of a wrong plan to achieve an aim (error of planning). An error may be an

act of commission or an act of omission (Institute of Medicine, 2004).

“Medication error” is defined as any error occurring in the medication-use process (Bates et al.,

1995). Examples include prescribing the wrong dosage, administering the wrong dosage of a

prescribed medication, failing to administer (by the provider) or take (by the patient) a

medication, or administering a drug to which the patient is known to be allergic.

“Adverse drug event” is defined as any injury due to medication (Bates et al., 1995). Examples

include a wrong dosage leading to injury (e.g., rash, confusion, or loss of function) or an

allergic reaction occurring in a patient not known to be allergic to a given medication.