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–MARYLAND –
Public and Private Policy
Medical Errors and Patient Safety

Definitions

Regulations were officially in force as of March 15, 2004. The Hospital Patient Safety Program regulations for the Department of Health and Mental Hygeine provide definitions. Included in the regulations are:

DEFINITIONS – Patient Safety Program
[COMAR 10.07.06.02]

Name Definition
Adverse Event means an unexpected occurrence related to a person's medical treatment and not related to the natural course of the person's medical treatment and not related to the natural course of the person's illness or underlying disease condition.
Serious Disability means a physicial or mental impairment that substantially limits one or more of the major life activities of an individual lasting more than 7 days or still present at time of discharge.
Level 1 Adverse Event means an adverse event that results in death or serious disability.
Level 2 Adverse Event means an adverse event that requires a medical intervention to prevent death or serious disability.
Level 3 Adverse Event means an adverse event that does not result in death or serious disability and does not require any medical interevention to prevent death or serious disability. Examples of Level 3 Adverse events include, but are not limited to:
◊  Medication Errors
◊  Falls
◊  Treatment Errors
◊  Infections
◊  Complications, etc. that do not require any medical intervention to prevent death or serious disability, that are unexpected occurrences, and that are not related to the natural course of the person's illness or underlying disease condition.
Near-Miss means a situation that could have resulted in an adverse event but did not, either by chance or through timely intervention. Examples of a “NEAR-MISS” include, but are not limited to the potential for an event leading to any of the examples listed for a Level 1, Level 2, OR Level 3 Adverse Event.

Furthermore, rather than distribute “interpretive guidelines” for these definitions, as is often published by other States (e.g., MA, NY, TN), the State of Maryland specifically leaves this issue with each hospital, requiring that each hospital "list and describe examples of adverse events that shall be reported," thereby developing a unique hospital-specific list [COMAR 10.07.04B(2)].

There are, therefore, no standardized reportable events for Maryland hospitals. If hospital adverse event data were publicly available, (which they are not), comparisons among hospitals would be treacherous.

The "list of examples of adverse events that shall be reported" was due to the Department by March 15, 2004.[COMAR 10.07.14A(4)], a fact reiterated in a March 10, 2004 memorandum distributed to all hospitals. [PDF]

This approach of asking hospitals to define the events is not too dissimilar from the JCAHO process in which it recommends to hospitals that it define ‘sentinel events’ "for its own purposes." JCAHO also provides for minimal ‘Reviewable Sentinel Event’ standards.

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