(1) The health carrier shall conduct a focused study relevant to the quality of its services for enrollee care. The health carrier must document the clinical focused study and submit it to the department by October 1 of each year.

(2) The health carrier shall select topics for the focused study that are justified based on any of the following considerations:

(a) areas of high volume;

(b) areas of high risk;

(c) areas where problems are expected or where they have occurred in the past;

(d) areas that can be corrected or where prevention may have an impact;

(e) areas that have potential adverse health outcomes; and

(f) areas where enrollee complaints have occurred.

(3) The health carrier shall document the study methodology employed, including:

(a) the focused study question;

(b) the sample selection;

(c) data collection;

(d) evaluation criteria; and

(e) measurement techniques.