Rule 4729:5-14-01 | Emergency Medical Services - Definitions.
As used in Chapter 4729:5-14 of the Administrative Code:
(A) "Business day" means any day other than Saturday, Sunday or a holiday recognized by the state of Ohio on which the offices of the board of pharmacy are not open for business.
(B) "Certificate to practice" means the level to which an individual is trained and licensed as defined in sections 4765.01, 4765.011 and 4765.30 of the Revised Code and rule 4765-1-01 of the Administrative Code.
(C) "Direct supervision" or "personal supervision" means EMS organization personnel shall be physically present at the licensed location or within the immediate proximity of an EMS unit to deter and detect the diversion of dangerous drugs.
(D) "Electronic signature" means any of the following attached to or associated with an electronic drug administration record by EMS organization personnel to authenticate the drug administration record:
(1) A private, unique personal identifier and secure passcode consisting of a combination of letters, numbers, and symbols that is adapted or executed by an individual as that individual's electronic signature.
(2) An electronic image of an individual's handwritten signature that is captured following drug administration and is created by using a writing apparatus (i.e. stylus). The signature shall be legible and include the person's first name, last name and credentials.
(3) Any other method approved by the board.
(E) "Emergency medical service organization" or "EMS organization" has the same meaning as in section 4765.01 of the Revised Code.
(F) "Medical director" means a physician to whom an EMS organization has designated, pursuant to section 4765.42 of the Revised Code, to perform the duties of medical director including establishing medical protocols that must be followed in the delivery of emergency medical services.
(G) "Mutual aid" means a formal written agreement between two or more EMS organizations to assist in emergency medical coverage in the other's usual area of coverage, including having access to dangerous drugs during the emergency.
(1) "Positive identification" means a method of identifying EMS personnel that does not rely solely on the use of a private personal identifier such as a password, but must also include a secure means of identification such as the following:
(a) A manual signature on a hard copy record;
(b) A magnetic card reader;
(c) A bar code reader;
(d) A biometric method;
(e) A proximity badge reader;
(f) A board approved system of randomly generated personal questions;
(g) A printout of every transaction that is verified and manually signed within a reasonable period of time by the individual who prescribed, administered, or dispensed the dangerous drug. The printout must be maintained for three years and made available on request to those individuals authorized by law to review such records; or
(h) Other effective methods for identifying individuals that have been approved by the board.
(2) A method relying on a magnetic card reader, a bar code reader, a proximity badge reader, or randomly generated questions for identification must also include a private personal identifier, such as a password, for entry into a secure mechanical or electronic system.
(I) "Posting up" means locating an EMS unit containing dangerous drugs at a location other than a location licensed by the board of pharmacy for less than twenty-four hours and where the EMS unit is under the direct supervision of the EMS personnel on duty.
(J) "Posting up at a special event" means locating an EMS unit containing dangerous drugs at a location other than a location licensed by the board of pharmacy for more than twenty-four consecutive hours pursuant to a formal agreement with the sponsors of the event and where the EMS unit is under the direct supervision of the EMS personnel on duty.
(1) Posting up at a special event requires notification to the board. Notification shall be provided prior to the special event in a manner determined by the board.
(2) The requirements of this paragraph do not apply in the event of an emergency management assistance compact or an emergency declared by the governor.
(K) "Protocol" or "standing order" means a definitive set of written treatment guidelines that include definitive orders for drugs and their specified dosages which have been authorized and signed by the EMS organization's medical director. A protocol may be used only by licensed or certified EMS personnel, in accordance with the individual's scope of practice, when providing limited medical services to individuals in an emergency.
(L) "Readily retrievable" means that records maintained in accordance with this chapter shall be kept in such a manner that they can be separated out from all other records and, upon request, produced for review no later than three business days to an agent, officer or inspector of the board.
(M) "Responsible person" has the same meaning as defined in agency 4729 of the Administrative Code and is responsible for the supervision and control of dangerous drugs as required in division (B) of section 4729.55 of the Revised Code, adequate safeguards as required in division (C) of section 4729.55 of the Revised Code, security and control of dangerous drugs and maintaining all drug records otherwise required.
(N) "Satellite" means a location licensed by the state board of pharmacy as a terminal distributor of dangerous drugs that is separate from the licensed headquarters of the EMS organization.
(O) "Scope of practice" has the same meaning as defined as in section 4765.35 of the Revised Code and rule 4765-12-04 of the Administrative Code for an emergency medical responder or first responder, section 4765.37 of the Revised Code and rule 4765-15-04 of the Administrative Code for an emergency medical technician or emergency medical technician-basic, section 4765.38 of the Revised Code and rule 4765-16-04 of the Administrative Code for an advanced emergency medical technician or emergency medical technician-intermediate, and section 4765.39 of the Revised Code and rule 4765-17-03 of the Administrative Code for a paramedic or emergency medical technician-paramedic.
(P) "Tamper-evident" means a package, storage container or other physical barrier is sealed or secured in such a way that access to the drugs stored within is not possible without leaving visible proof that such access has been attempted or made.