Iowa Admin. Code r. 657-11.11

Current through Register Vol. 47, No. 6, September 18, 2024

Rule 657-11.11 - Policies and procedures

(1) The service director, the medical director, and the responsible individual shall develop, implement, and adhere to written policies and procedures for the operation and management of the service program with respect to prescription drugs and devices in accordance with these rules. These policies and procedures shall be available for inspection and copying by the board, its representative, or any other authorized individual. The policies and procedures shall be periodically reviewed by the responsible individual, the medical director, and the service director and shall identify the frequency of the review. Documentation of the review shall be maintained.

(2) The policies and procedures shall address, at a minimum, the following:

a. Storage of drugs at the primary program site and any program substations, including appropriate temperature controls , temperature monitoring and response when drugs are exposed to extreme temperatures pursuant to rule 657-11.13 (124,147A,155A).

b. Storage of drugs at the primary program site and any program substations, including adequate security to prevent diversion and unauthorized access to drugs and records pursuant to rule 657-11.13(124,147A,155A).

c. Protocols for administration of drugs pursuant to rule 657-11.14(124,147A,155A).

d. Administration of drugs outside the parameters of written protocols pursuant to rule 657-11.15 (124,147A,155A).

e. Service program personnel matters including, but not limited to:

(1) Access to prescription drugs and records, identifying level of access based upon employee certification level and scope of practice.

(2) Authority to administer drugs based upon employee certification level and scope of practice.

(3) Authority to order, receive, and distribute prescription drugs and devices.

(4) Initial training and periodic review of the medication policies and procedures.

(5) Identification of registered nurses not employed by the service program who are authorized by the medical director pursuant to Iowa Code section 147A.12 and pursuant to rules of the board of nursing to provide emergency care under the service program's protocol.

f. Process for the return of drugs pursuant to rule 657-11.22 (124,147A,155A).

g. Out-of-date and adulterated drugs pursuant to rule 657-11.23 (124,147A,155A).

h. Drug and device recalls pursuant to rule 657-11.24(124,147A,155A).

i. Monthly inspections pursuant to rule 657-11.20 (124,147A,155A).

j. Record retention as described in rule 657-11.34(124,147A,155A) and other applicable rules of the board.

Iowa Admin. Code r. 657-11.11

ARC 9786B, lAB 10/5/11, effective 11/9/11; ARC 0342C, lAB 10/3/12, effective 11/7/12

Amended by IAB June 7, 2017/Volume XXXIX, Number 25, effective 7/12/2017