65G-7.001. Definitions  

Effective on Monday, July 1, 2019
  • 1The terms and phrases used in this chapter shall have the meanings defined below:

    15(1) “Administration of medication” means the obtaining and giving of one or more doses of medicinal substances by an authorized person to an Agency client for his or her consumption.

    45(2) “Administration route” means the path through which medication or prescribed formula is delivered to a client. For purposes of this chapter, administration routes include the following:

    72(a) “Enteral,” which means medication or prescribed enteral formula is delivered by gastrostomy jejunostomy tube, or gastrostomy-jejunostomy tube, via the body’s gastrointestinal system.

    96(b) “Inhaled,” which means medication is administered as nose drops or nose spray, or medication is inhaled by mouth, such as an inhaler or nebulizer.

    122(c) “Ophthalmic,” which means solution or ointment medication is instilled into the eye or applied on or around the eyelid.

    143(d) “Oral,” which means medication 149including, but not limited to, 154tablet, capsule, liquid, or powder form is introduced into the gastrointestinal tract by mouth.

    168(e) “Otic,” which means solutions or ointment medication is placed in the outer ear canal or applied around the outer ear.

    190(f) “Parenteral,” which means medication is injected into the body through some route other than the digestive tract, such as subcutaneous, intra-dermal, intra-muscular, or intravenous administration.

    217(g) “Rectal,” which means any medication including, but not limited to, capsule, enema, gel, or suppository is administered via the rectum.

    239(h) “Topical,” which means medication including, but not limited to, salve, lotion, ointment, cream, spray, shampoo, or solution is applied locally to a body part.

    265(i) “Transdermal,” which means a patch containing a pre-measured or measured amount of topical medication that is absorbed into the body via the epidermis (outer layer of skin).

    294(j) “Vaginal,” which means any medication including, but not limited to, capsule, cream, or ointment that is administered via the internal vagina. This route does not include medications applied to the epidermis external to the vagina.

    331(3) “Advanced Practice Registered Nurse” or “APRN” means any person licensed or authorized by the State of Florida to practice professional nursing and certified in advanced or specialized nursing practice, including certified registered nurse anesthetists, certified nurse midwives, and nurse practitioners, pursuant to chapter 464, F.S.

    377(4) “Client’s record” means a file maintained by the Waiver Support Coordinator for each client that contains the client’s name and date of birth, written authorization for routine medical/dental care from the client or legal representative medical summary, the name address and telephone number of the client’s physician(s) and dentist(s), a record of the client’s illnesses and accidents, the legal status of the client, current services and support plan, and client financial documentation. This shall be taken to include any central client record as maintained under the Agency data management system, whether paper or electronic in format.

    474(5) “Controlled medication” means any substance enumerated in Schedules I, II, III, IV, and V, in section 491893.03, F.S.

    493(6) “Corrective Action Plan” means a written plan of action developed by the provider in cooperation with the Agency for correcting cited deficiencies in compliance with this chapter.

    521(7) “Current prescriber order” means a prescription or order that has not been discontinued by the prescriber and may be dispensed until the prescribed number of refills has been fulfilled and administered, or until the medication has expired.

    559(8) “Dispense” means the same as defined in section 568465.003(6), F.S.

    570(9) “Drug monograph” means the informational documents that are provided every time a new medication is ordered for a patient that contains specific drug-related uses, warnings, side effects and other information, depending on the medication dispensed.

    606(60710) “Expiration date of a prescription” is the date after which the prescription may not be dispensed by the pharmacy, or one year after the written date of the prescription, except in the case of a controlled medication, which, depending on class, could expire at any time, from immediately after the first fill to twelve months from the written date of the prescription.

    670(11) “Expired medication” is a medication that shall not be administered because the expiration date of the medication has passed. The expiration date of a medication is the date after which the medication expires per the pharmacist’s label or the label provided by the manufacturer on over-the-counter medications.

    718(12) “Facility” means a residential facility licensed under chapter 393, F.S., or other facility staffed by direct service providers where Agency clients receive training, respite care, or other services on a regularly scheduled basis.

    752(13) “Informed Consent for Medication Administration” means the specific consent a client or client’s legal representative gives to a provider that allows that provider to assist the client with medication administration, and on which the client or the client’s legal representative acknowledges that the provider is not professionally licensed to provide medication administration assistance.

    806(14) “Legal Representative” means:

    810(a) For clients under the age of 18 years, the legal representative or health care surrogate appointed by the Florida court to represent the child or anyone designated by the parent(s) of the child to act in the parent(s)’ behalf (e.g., due to military absence).

    855(b) For clients age 18 years or older, the legal representative could be the client, anyone designated by the client through a Power of Attorney or Durable Power of Attorney, a medical proxy under chapter 765, F.S., or anyone appointed by a Florida court as a guardian or guardian advocate under chapter 393 or 744, F.S.

    911(15) “Licensed Practical Nurse” or “LPN” means any person licensed or authorized by the State of Florida to practice practical nursing pursuant to chapter 464, F.S.

    937(16) “Medical Case Manager” or “MCM” means a health care practitioner employed by the Agency to provide consultation and technical assistance regarding the health and safety of Agency clients.

    966(17) “Medication” means over-the-counter medications and prescribed medications.

    974(18) “Medication Administration Record” or “MAR” means the chart maintained for each client that records the medication administration information required by this Chapter. Other information or documents pertinent to medication administration may be attached to the MAR.

    1011(19) “Medication Administration Trainer” or “Trainer” means an individual who is licensed or authorized to practice nursing by the State of Florida pursuant to chapter 464, F.S., and who obtains Agency approval to train MAP applicants in Basic Medication Administration or Prescribed Enteral Formula Administration, 1056pursuant to rule 105965G-7.003, 1060F.A.C.

    1061(20) “Medication Assistance Provider” or “MAP” means a direct service provider not otherwise licensed to administer medication who has successfully completed an Agency-provided training course taught by an Agency-approved Trainer and has current validation to provide clients with medication administration or supervise clients with self-administration of medication.

    1108(21) “Nebulizer” means an electrically-powered (including battery-powered) machine that turns liquid medication into a mist so that it can be breathed directly into the lungs through a mouthpiece or face mask.

    1139(22) “Over-the-counter or “OTC” medication” means a medication for general distribution that is available to the general public for use in the treatment of human illnesses, ailments, or injuries.

    1168(23) “Pharmacist” means any person licensed pursuant to section 1177465.003, F.S., 1179to practice the profession of pharmacy.

    1185(24) “Pharmacy profile” means the electronic file kept by the client’s pharmacy that maintains client-specific information and prescription history, such as date of birth, diagnoses, allergies, insurance information, and medication history.

    1216(25) “Physician” means a Doctor of Medicine or Osteopathy who holds a valid and active license in full force and effect pursuant to the provisions of chapter 458 or 459, F.S.

    1247(26) “Physician Assistant” or “PA” means a person who is a graduate of an approved program or its equivalent or who meets standards approved by the Board of Medicine and is licensed to perform medical services delegated by the supervising physician or osteopathic physician pursuant to chapters 458 and 459, F.S.

    1298(27) “Prescribed medication” means simple or compound substances, mixtures of substances, or prescribed enteral formulas that are prescribed for the care, mitigation, or prevention of disease or for health maintenance by a licensed practitioner authorized by the laws of the State of Florida to prescribe or order such substances.

    1347(28) “Prescription” includes any order for drugs or medicinal supplies written or transmitted by any means of communication by a practitioner licensed or legally authorized by the State of Florida to prescribe such drugs or medicinal supplies and which is intended to be dispensed by a pharmacist. The term also includes a verbally transmitted order to the pharmacist by the lawfully designated agent of such practitioner. The term also includes an order written or transmitted by a practitioner licensed to practice in a jurisdiction other than this state, but only if the pharmacist called upon to dispense such order determines, in the exercise of her or his professional judgment, that the order is valid and necessary for the treatment of a chronic or recurrent illness. The term “prescription” also includes a pharmacist’s order for a product selected from the formulary created pursuant to section 1491465.186, F.S. 1493Prescriptions may be retained in written form or the provider may cause them to be recorded in a data processing system, provided that such order can be produced in printed form upon lawful request, per section 1529465.003(14), F.S.

    1531(29) “Primary route of medication administration” or “primary route” means the oral route, or in the case of a MAP who primarily administers medication via the enteral route, this term means the enteral route. The primary route refers to the route of medication administration that is used to determine the annual validation date of a specific MAP for the purpose of requiring retraining and validation if a lapse in validation occurs.

    1602(30) “Provider” means either a single person providing services to a client of the Agency, including a CDC+ provider, or a business entity such as a Group Home or Adult Day Training Center providing services to clients of the Agency.

    1642(311643) “PRN” or “pro re nata” means the administration of medication on an as-needed basis rather than per a prescribed schedule.

    1664(32) “Regional Office” is one of the local offices responsible for managing one of the Agency’s six service areas.

    1683(33) “Registered Nurse” or “RN” means any person licensed or authorized by the State of Florida to practice professional nursing, pursuant to chapter 464, F.S.

    1708(34) “Self-administration of medication without supervision” means that the client is capable of self-administering his or her own medications without any supervision, monitoring, verbal prompting, physical assistance, or cuing from staff.

    1739(35) “State Office” is the Agency’s headquarters, situated at 4030 Esplanade Way, Suite 380, Tallahassee, FL 32399-0959; main telephone number (850)488-4257.

    1760(36) “Supervised self-administered medication” means direct, face-to-face observation of a client during the client’s self-administration of medication and includes instruction or other assistance necessary to ensure correct self-administration of the medication.

    1791(37) “Supported living” means the provision of supports necessary for an adult who has a developmental disability to establish, live in, and maintain his or her own household in the community.

    1822(381823) “Unlicensed” means, for purposes of this rule, any direct service provider not licensed, authorized, certified, or otherwise permitted by Florida law to administer medication or to supervise a client’s self-administration of medication.

    1856(39) “Validation” means a MAP or MAP applicant’s on-site demonstration of competency in administering or supervising self-administration of medication(s) to a client, certified by a Validation Trainer following the direct service provider’s successful completion of an Agency-provided medication administration training course, or successful annual completion of an Agency provided in-service on medication error prevention and medication administration.

    1913(40) “Validation Trainer” means a practitioner who is licensed or authorized to practice nursing by the State of Florida pursuant to chapter 464, F.S., or who is licensed or authorized to practice medicine by the State of Florida pursuant to chapter 458 or 459, F.S., and who obtains Agency approval to validate MAPs or MAP applicants in Medication Administration or Prescribed Enteral Formula Administration, pursuant to rule 65G-7.0035, F.A.C.

    1982(41) “Validation by simulation” means the in-person, one-on-one imitation by a MAP or MAP applicant of the actual process utilized when administering medication or supervising the self-administration of medication by a particular route, which must occur as part of the required Medication Administration Training Course.

    2027(42) “Waiver Support Coordinator” or “WSC” means a Support Coordinator as defined in section 2041393.063(41), F.S.

    2043Rulemaking 2044a2045uthority 2046393.501, 2047393.506 FS. 2049Law Implemented 2051393.506 FS. 2053History–New 3-30-08, Amended 7-1-19.