Definitions, Determination of Need for Assistance with Medication Administration; Informed Consent, Medication Administration Training Course, Validation Requirements, Medication Administration Procedures, Medication Errors, Storage Requirements, ...
DEPARTMENT OF CHILDREN AND FAMILY SERVICES
Agency for Persons with DisabilitiesRULE NO: RULE TITLE
65G-7.001: Definitions
65G-7.002: Determination of Need for Assistance with Medication Administration; Informed Consent
65G-7.003: Medication Administration Training Course
65G-7.004: Validation Requirements
65G-7.005: Medication Administration Procedures
65G-7.006: Medication Errors
65G-7.007: Storage Requirements
65G-7.008: Documentation and Record Keeping
65G-7.009: Off-site Medication AdministrationNOTICE OF CHANGE
Notice is hereby given that the following changes have been made to the proposed rule in accordance with subparagraph 120.54(3)(d)1., F.S., published in Vol. 33 No. 40, October 5, 2007 issue of the Florida Administrative Weekly.
These changes respond to comments by the Joint Administrative Procedures Committee and to suggestions made during public hearing held on November 19, 2007.
Chapter 65G-7 MEDICATION ADMINISTRATION
65G-7.001 Definitions.
The terms and phrases used in this chapter shall have the meanings defined below:
(1) No change.
(2) No change.
(3) “Advanced Registered Nurse Practitioner (ARNP)” means a registered nurse certified by the Florida Board of Nursing as an ARNP and who holds a valid and active license in full force and effect pursuant to section 464.012, F.S., or the applicable licensing laws of the state in which the service is furnished.
(4) through (5) renumbered (3) through (4) No change.
(5)(6) “Client’s record” means a file maintained for each client that contains the client’s name and date of birth, written authorization for routine medical/dental care from the client or guardian and medical summary, the name address and telephone of the client’s physician and dentist, a record of the client’s illnesses and accidents, the legal status of the client, current services and implementation plan, and client financial documentation
(7) through (12) renumbered (6) through (11) No change.
(12)(13) “Medication Administration Record” or “MAR” means the chart daily record maintained for each client which records that documents medication information as required by this rule chapter. Other information or document pertinent to medication administration may be attached to the MAR. A copy of the Agency’s form “Medication Administration Record,” APD Form 65G7-00 (00/00/00), incorporated herein by reference, may be obtained by writing or calling the Agency for Persons with Disabilties, at 4030 Esplanade Way, Suite 380, Tallahassee, FL 32399-0950; main phone number (850)488-4257.
(14) through (33) renumbered (13) through (32) No change.
Specific Authority 393.501 FS. Law Implemented 393.506 FS. History–New ________.
65G-7.002 Determining Need for Assistance; Informed Consent Requirement.
(1) An Agency client’s need for assistance with medication administration or ability to self-administer medication without supervision must be documented by the client’s physician, physician assistant, or Advanced Registered Nurse Practitioner, licensed under Chapter 464, 458, or 459, F.S., to practice in the State of Florida, ARNP on an “Authorization for Medication Administration,” APD Form 65G7-01, (00/00/00), incorporated herein by reference. A copy of the form may be obtained by writing or calling the Agency for Persons with Disabilities, at 4030 Esplanade Way, Suite 380, Tallahassee, FL 32399-0950; main phone number (850)488-4247.
(2) A client who is authorized, as provided above, to self-administer medication without supervision shall be encouraged to do so. The medication assistance provider shall assist the client by making the medication available and reminding the client to take medication at appropriate times.
(3) The medication assistance provider must maintain a current Authorization form in the client’s MAR, reviewed by the client’ physician, physician assistant, or ARNP at least annually and upon any significant change to the client’s medical condition or self- sufficiency which would affect the client’s ability to self-administer medication or tolerate particular medication routes.
(4) No change.
(5) In addition to an executed Authorization for Medication Administration and before providing a client with medication assistance, a the medication assistance provider must also obtain from the client or the client’s authorized representative an “Informed Consent for Medication Administration” APD Form 65G7-02 (00/00/00), incorporated herein by reference before providing a client with medication administration assistance. A copy of the form may be obtained by writing or calling the Agency for Persons with Disabilities, at 4030 Esplanade Way, Suite 380, Tallahassee, FL 32399-0950; main phone number (850)488-4257. The Informed Consent Form must will contain a description of the medication routes and procedures that the medication assistance provider is authorized to supervise or administer.
(6) The medication assistance provider may not also act as the client’s health care surrogate or proxy, or sign the Medication Administration Informed Consent form referenced above. Direct service Pproviders or other facility staff may witness the execution of the form.
(7) No change.
(8) The requirements of this rule chapter do not apply to the following:
(a) through (b) No change.
(c) Unlicensed direct service Pproviders employed by or under contract with State Medicaid intermediate care facilities for the developmentally disabled, regulated through Chapter 400, Part VIII, F.S., providers employed by or under contract with licensed home health agencies regulated under Chapter 400, Part III, hospices regulated under Chapter 400, Part IV, assisted living facilities, hospices, or health care service pools regulated through Chapter 400, Part IX, F.S., or provider employed by or under contract with assisted living facilities regulated through Chapter 429, Part I, F.S.; and
(d) Clients authorized to self-administer medication without assistance or supervision, as documented by an executed Authorization, APD Form 65G7-01 (00/00/00), incorporated herein by reference. A copy of the form may be obtained by writing or calling the Agency for Persons with Disabilities, at 4030 Esplanade Way, Suite 380, Tallahassee, FL 32399-0950; main phone number (850)488-4257.
Specific Authority 393.501 FS. Law Implemented 393.506 FS. History–New ________.
65G-7.003 Medication Administration Training Course.
(1) Medication administration training courses not offered through the Agency must be approved by the Agency in order to provide qualification for validation. To obtain Agency approval, a course provider must submit an application on a “Medication Administration Provider/Course Approval Form,” APD Form 65G7-03 (00/00/00), incorporated herein by reference. A copy of the form may be obtained by writing or calling the Agency for Persons with Disabilities, at 4030 Esplanade Way, Suite 380, Tallahassee, FL 32399-0950; main phone number (850)488-4257. Course providers offering medication administration training at the time this rule is adopted shall have 180 days from the effective date of the rule to request and receive Agency approval for their course, during which time they may continue to offer the training.
(2) through (3) No change.
(4) Only licensed registered nurses or Advanced Registered Nurse Practitioners ARNPs may conduct training courses for medication administration assistance certification.
(5) Medication administration training courses must provide training curriculum and step-by-step procedures covering, at a minimum, the following subjects:
(a) No change.
(b) Comprehensive understanding of and compliance with medication instructions on a prescription label, a health care practitioner’s order, and proper completion of a MAR form;
(c) through (i) No change.
(j) Validation requirements procedures for medication administration assistance.
(6) through (8) No change.
(9) Any material change to an approved course curriculum or protocol requires new agency approval for that course.
(10) No change.
(11) The Agency may deny or withdraw course approval for any of the following acts or omissions:
(a) through (g) No change.
(h) Administration of the course training by unqualified instructors not licensed as registered nurses or Advanced Registered Nurse Practitioners;
(i) No change.
(12) through (13) No change.
Specific Authority 393.501 FS. Law Implemented 393.506 FS. History–New ________.
65G-7.004 Validation Requirements.
(1) An unlicensed direct service provider applying for validation as a medication assistance provider must be assessed and validated at least annually, through demonstration, as competent to administer medication or to supervise the self-administration of medication. Successful completion of an Agency-approved medication administration course is a prerequisite to an assessment of competency validation.
(2) No change.
(3) The applicant for validation must complete an on-site assessment with 100% proficiency competency documented on a “Validation Certificate,” APD Form 65G7-004 (00/00/00) incorporated herein by reference. A copy of the form may be obtained by writing or calling the Agency for Persons with Disabilities, at 4030 Esplanade Way, Suite 380, Tallahassee, FL 32399-0950; main phone number (850)488-4257. The form must contain the following information:
(a) through (f) No change.
(4) Successful assessment and validation requires that the applicant demonstrate in an actual on-site client setting his or her capability to correctly administer medication and supervise the self-administration of medications in a safe and sanitary manner as required by this rule chapter, including a demonstration of the following proficiencies:
(a) The ability to comprehend and follow medication instructions on a prescription label, physician’s order, and properly complete a MAR form;
(c) through (j) renumbered (b) through (i) No change. (correct scrivener’s error)
(5) No change.
(6) A medication assistance provider must be re-validated annually within the at least 60 days preceding before the expiration of his or her current validation. An unlicensed direct service provider may not under any circumstances administer or supervise the self-administration of medication before receiving validation or following expiration of an annual validation.
(7) through (8) No change.
Specific Authority 393.501 FS. Law Implemented 393.506 FS. History–New ________.
65G-7.005 Medication Administration Procedures.
(1) No change.
(2) A validated medication assistance provider must comply with the following requirements:
(a) through (d) No change;
(e) Limit administration, or assistance in with self-administration, to medications prescribed in writing by the client’s health care practitioner and properly labeled and dispensed in accordance with Chapters 465 and 499, F.S.;
(f) through (k) No change.
(3) A medication assistance provider may not assist with the administration of any OTC medication or medication samples without a written order by the client’s primary care physician or Advanced Registered Nurse Practitioner ARNP.
(4) No change.
(5) The medication assistance provider is responsible for ensuring that the prescription for a that medication is promptly refilled so that a client does not miss a prescribed dosage of medication. If the medication assistance provider is not responsible for routine refills of a medication, he or she shall notify the provider responsible for refilling the client’s prescriptions that the client is in need of medication, and document this notification.
(6) The medication assistance provider may not assist with PRN medications, including OTC medications, unless a health care practitioner has provided written directions for the medication. The provider must attach to the client’s MAR a copy of the prescription or order legibly displaying the following information:
(a) No change;
(b) The prescription number, if applicable;
(c) through (d) No change;
(7) No change.
65G-7.006 Medication Errors.
(1) No change.
(2) Immediately following a medication error, the medication assistance provider or facility administrator must take the following steps:
(a) through (b) No change.
(c) Notify the client’s prescribing health care practitioner of the error any omitted doses of medication, request that the practitioner prepare and fax a medication directive addressing the error medication omission to the client’s home, facility, or pharmacy and document the client’s health care practitioner’s response; and
(d) Fully document all observations and contacts made regarding a medication error in a “Medication Error Report,” APD Form 65G7-05 (00/00/00), incorporated herein by reference, and place a copy of the Report in the client’s file. A copy of the form may be obtained by writing or calling the Agency for Persons with Disabilities, at 4030 Esplanade Way, Suite 380, Tallahassee, FL 32399-0950; main phone number (850)488-4257.
(3) through (6) No change.
Specific Authority 393.501 FS. Law Implemented 393.506 FS. History–New ________.
65G-7.007 Storage Requirements.
(1) Medication assistance providers must observe the following medication storage requirements:
(a) No change;
(b) Destroy any prescription medication that has expired or is no longer prescribed and document the medication disposal on a “Medication Destruction Record,” APD 65G7-06 (00/00/00), incorporated herein by reference, and sign the Record before a third- party witness;
(c) through (d) No change.
A copy of the “Medication Destruction Record,” APD Form 65G7-06 (00/00/00) may be obtained by writing or calling the Agency for Persons with Disabilities, at 4030 Esplanade Way, Suite 380, Tallahassee, FL 32399-0950; main phone number (850)488-4257.
(2) through (5) No change.
(6) Medications requiring refrigeration must be stored in a refrigerator. The medications shall be stored in their original containers either within a locked storage container clearly labeled as containing medications or in a refrigerator located in a locked, secured medication storage room.
(7) No change.
(8) Controlled medication storage requires the following additional safeguards:
(a) No change;
(b) For facilities operating in shifts, a medication assistance provider must perform controlled medication counts for each incoming and outgoing personnel shift, as follows:
1. through 2. No change.
3. The providers must record the medication count on a “Controlled Medication Form,” APD Form 65G7-007 (00/00/00), incorporated herein by reference, signed and dated by the providers verifying the count; and
4. No change.
A copy of the “Controlled Medication Form, APD Form 65G7-07 (00/00/00) may be obtained by writing or calling the Agency for Persons with Disabilities, at 4030 Esplanade Way, Suite 380, Tallahassee, FL 32399-0950; main phone number (850)488-4257.
(e) through (f) No change.
Specific Authority 393.501 FS. Law Implemented 393.506 FS. History–New ________.
65G-7.008 Documentation and Record Keeping
(1) An up-to-date MAR shall be maintained for each client requiring assistance with medication administration, except when the client is off-site. The medication assistance provider must document the administration of medication or supervision of self- administered medication immediately on the MAR, using either APD Form 65G7-00 (00/00/00), incorporated by reference at subsection 65G-7.001(12), F.A.C., or on an alternative MAR form that includes. Each MAR page must include the following information:
(a) through (n) No change.
(2) No change.
Specific Authority 393.501 FS. Law Implemented 393.506 FS. History–New ________.
65G-7.009 Off-site Medication Administration.
(1) If a client will be away from a licensed residential facility or supported living home and requires during that time administration of medication by persons other than the medication assistance provider, the medication assistance provider must comply with the following requirements to assure that the client has appropriate medications during his or her absence:
(a) through (b) No change.
(c) Record both medication counts in a “Off-site Medication Form,” APD Form 65G7-08 (00/00/00), incorporated herein by reference. A copy of the form may be obtained by writing or calling the Agency for Persons with Disabilities, at 4030 Esplanade Way, Suite 380, Tallahassee, FL 32399-0950; main phone number (850)488-4257.
(2) through (3) No change.
Specific Authority 393.501 FS. Law Implemented 393.506 FS. History–New ________.
