1. A. In this chapter, the following terms have the meanings indicated.

2. B. Terms Defined.

   1. (1) “Action plan” means a written document that includes:

      1. (a) Specific measures to correct problems or areas of concerns;
      2. (b) Specific measures to address areas of system improvement;
      3. (c) Time frames for implementation of any specific measures; and
      4. (d) Title of responsible individual to monitor implementation and effectiveness.
   2. (2) “Adverse event” means an unexpected occurrence related to an individual's medical treatment and not related to the natural course of the patient's illness or underlying disease condition.
   3. (3) “Department” means the Maryland Department of Health.
   4. (4) “Level 1 adverse event” means an adverse event that results in death or serious disability.
   5. (5) “Level 2 adverse event” means an adverse event that requires a medical intervention to prevent death or serious disability.
   6. (6) “Level 3 adverse event” means an adverse event that does not result in death or serious disability and does not require any medical intervention to prevent death or serious disability.
   7. (7) “Medical review committee” has the meaning stated in Health Occupations Article, §1-401, Annotated Code of Maryland.
   8. (8) “Near-miss” means a situation that could have resulted in an adverse event but did not, either by chance or through timely intervention.
   9. (9) “Patient safety program” means an ongoing, proactive program for identifying risks to patient safety and reducing medical errors which is one component of the hospital-wide risk management program.
   10. (10) “Root cause analysis” means a medical review committee process as defined under Health Occupations Article, §1-401, Annotated Code of Maryland, for identifying the basic or contributing causal factors that underlie variations in performance associated with adverse events or near-misses.
   11. (11) “Serious disability” means a physical or mental impairment that substantially limits one or more of the major life activities of an individual lasting more than 7 days or still is present at the time of discharge.

Authority: Health-General Article, §§19-308 and 19-319, Annotated Code of Maryland

Effective date: March 15, 2004 (31:5 Md. R. 448)

Regulation .15B amended effective February 26, 2018 (45:4 Md. R. 206)

Regulation .17 adopted effective February 26, 2018 (45:4 Md. R. 206)