Section 856IAC1-28.1-11. Performance improvement events, sentinel events, corrective and avoidance measures, review, records, and documentation

   (a) The pharmacist in charge shall, as a part of the pharmacy's performance improvement program, assure or be responsible for assuring that data are collected to:

(1) monitor the stability of existing medication use processes;

(2) identify opportunities for improvement; and

(3) identify changes that will lead to and sustain improvement.

  (b) Identification of quality related or sentinel event as defined in section 1 of this rule shall be cause for:

(1) an intensive analysis of causal factors involved in the event; and

(2) plans for corrective actions.

  (c) Records of all processes, analysis, and corrective measures instituted involving such pharmacy quality related or sentinel event shall be maintained for a period of not less than two (2) years.

  (d) The committee created under section 5(c)(1) of this rule shall, at a minimum, consider the effects on quality of the pharmacy system due to the following:

(1) Staffing levels of both professional and technical personnel.

(2) Workflow.

(3) Use of technology.

  (e) Requirements for documentation of performance improvement monitoring of medication use processes, confidentiality of records, summarization, and examination by the board shall be as follows:

(1) Each quality related or sentinel event that occurs, or is alleged to have occurred, as the result of activities involving pharmacy operations, shall be documented in a written or electronic storage record created solely for that purpose.

(2) The quality related or sentinel event shall be:

(A) initially documented by the pharmacist to whom it is first described; and

(B) recorded on the same day of its having been so described to the pharmacist.

(3) Documentation shall include a description of the event that is of sufficient detail to permit analysis of the event.

(4) The pharmacist in charge shall summarize, or cause to be summarized, efforts to improve the medication use process on a semiannual basis.

(5) No patient names or employee names shall be included in this summary report.

(6) This report shall be maintained for a period of not less than two (2) years.

(7) The records created and maintained as a component of a pharmacy performance improvement program are confidential to the extent law permits. However, to assure compliance, the board or its representative may review the policies and procedures manual and a summarization of events described in subsection (b).

(Indiana Board of Pharmacy; 856 IAC 1-28.1-11; filed Dec 26, 2001, 2:44 p.m.: 25 IR 1640; readopted filed Sep 26, 2008, 10:55 a.m.: 20081015-IR-856080346RFA; readopted filed Dec 1, 2014, 8:33 a.m.: 20141231-IR-856140392RFA)