Conn. Agencies Regs. § 21a-262-9

Current through June 15, 2024
Section 21a-262-9 - Hospital patient care areas, hospital nursing stations, other hospital drug storage locations, chronic and convalescent nursing homes, rest homes with nursing supervision, children's nursing homes, and areas and locations within correctional and/or juvenile training facilities, youth service facilities, mentally retarded facilities, and any other location other than pharmacies, hospital clinical laboratories, satellite pharmacies, or drug rooms, wherein drugs are stored, prepared, or dispensed not specifically referred to in section 21a-262-1 through section 21a-262-10 inclusive
(a) Schedule II Controlled Substances in small amounts not exceeding the quantity necessary for efficient operation kept at any specific individual area or location shall be stored in a locked substantially constructed nonportable and immobile metal cabinet or metal container within another separate locked enclosure. Keys shall not be the same for each of these locks and such keys shall be kept on two separated key rings or holders. Not more than one set of keys for the schedule II controlled substance cabinets shall be available to nonsupervisory personnel.
(b) At the beginning of each work period or shift, a nurse must be assigned responsibility for the security of schedule II controlled substance stock. Such responsibility shall be assumed by each said nurse who shall prepare a signed inventory indicating each kind and quantity of schedule II controlled substance received, the time and date received, and from whom received. This responsibility shall not be transferred or assigned to another nurse or person during the course of each work period or shift unless another signed inventory transferring responsibility is first prepared. For systems regulated under subsection (h) of this section, the requirements of this subsection shall be extended to include schedule III, IV and V controlled substance stock in addition to schedule II controlled substance stock.
(c) Schedule III, IV, V Controlled Substance Stock in small amounts not exceeding the quantity necessary for normal efficient operation of each individual unit shall be stored with Schedule II Controlled Substances in compliance with security measures as required per Section 21a-262-9(a) or separately from other drugs and/or substances in a separate secure locked nonportable immobile substantially constructed cabinet or container. Access to such cabinet or container shall be limited to a minimum number of personnel essential for efficient operation.
(d) Schedule III, IV, V Controlled Substance Stock in small quantities intended for emergency use only, may be stored within an emergency drug kit or on emergency crash carts equipped with disposable locking or sealing devices, provided adequate security measures for such controlled substance stock are maintained and required record-keeping procedures are complied with.
(e) The same security requirements shall apply for controlled substances obtained pursuant to individual patient(s) prescriptions as for stock controlled substances as outlined under this section 21a-262-9 inclusive. Controlled substances obtained pursuant to such individual patient(s) prescriptions shall not be used for any other patient(s) and when no longer required for the intended specific individual patient, shall be securely kept and safeguarded until properly disposed of.
(f) In cases involving Unit Dose or experimental, trial, new, or innovative drug distribution procedures, the Commissioner of Consumer Protection may approve of other controlled substance(s) security safeguards for a specific time period, in lieu of any required by section 21a-262-1 through section 21a-262-10 inclusive, on an individual basis after evaluating each such drug distribution procedure. Such approval may be extended indefinitely by said Commissioner upon such successful completion of the trial period. If approval is not given by said Commissioner prior to the implementation of any such drug distribution procedure, controlled substance security requirements as outlined in section 21a-262-1 through section 21a-262-10 inclusive shall apply.
(g) Where unwanted partial or individual doses of Controlled Substances are discarded by nursing personnel, a record of each such destruction must be made indicating the date and time of each such destruction; the name, form, strength, and quantity of Controlled Substance destroyed; the signature of the nurse destroying the Controlled Substance, and the signature of another nurse who witnesses such destruction. In other than hospital locations, an authorized person may witness such destruction.
(h) In cases involving distribution of an individual patient's controlled substance medication by means of the use of mobile medication carts within chronic and convalescent nursing homes, and rest homes with nursing supervision, the following security safeguards shall be approved in lieu of any required by section 21a-262-9(a) and (c); except that compliance with this subsection shall not be required of a facility using a mobile medication cart system previously approved for use in that facility by the commissioner of consumer protection. Compliance with this subsection by facilities with previously approved systems shall be in lieu of the requirements of such previously approved systems.
(1) Mobile medication carts shall be of substantial construction and shall incorporate the following security features:
(A) A separate, lockable, non-removable drawer or compartment for storage of all controlled substances,
(B) The key which locks the controlled substance drawer or compartment shall be different from the key(s) to all other locking devices on each cart and such keys shall not be interchangeable between carts within the same facility, and
(C) Locking mechanism(s) which will secure the entire contents of the cart without requiring the use of a key;
(2) Mobile medication carts when not in use shall be locked and stored within a limited access locked and enclosed medication room or closet or other substantially constructed enclosed structure;
(3) Mobile medication carts shall be securely locked at all times when unattended. All medication and injection equipment shall be stored within the locked cart. Locking devices shall be maintained in good working order;
(4) The separate controlled substance drawer or compartment shall be securely locked at all times except for the actual time required to remove or replace needed items or to conduct an audit;
(5) The keys to the controlled substance drawer or compartment of each mobile cart shall be separated from the keys to the other locking devices of that cart and shall be carried personally by the nurse responsible for the required controlled substance audit during each nursing shift and no duplicate keys shall be available to other than specifically designated supervisory personnel;
(6) Requirements of section 21a-262-9(b) concerning audits of controlled substance stocks shall be extended to include schedule III, IV, and V controlled substance stock in addition to schedule II controlled substance stock;
(7) Record keeping entries of controlled substances administered shall be made at the time of administration;
(8) The director of nursing or his/her nursing supervisor designee shall conduct unannounced documented audits of all controlled substance stocks on all units at least twice a month; and
(9) All controlled substance medications shall be inventoried when received and immediately placed into the controlled substance drawer or compartment within the mobile cart. Quantities of patients' controlled substance medications stored within mobile medication carts shall be limited to the minimum quantities necessary to provide for normal efficient operation and shall be promptly removed for proper disposition when no longer needed by the patient.
(i) In cases involving distribution of an individual patient's controlled substance medication by means of the use of mobile medication carts within chronic and convalescent nursing homes, and rest homes with nursing supervision, other security safeguards in lieu of any required by section 21a-262-9(h) may be approved by the commissioner of consumer protection on an individual basis after evaluating the drug distribution procedure of the applicant for approval pursuant to this subsection.

Conn. Agencies Regs. § 21a-262-9

Effective July 27, 1984