Definitions, Authorization for Medication Administration and Informed Consent, Self-Administration of Medication without Supervision, Medication Administration Trainer Requirements, Medication Administration Training Course Curriculum Requirements, ...
DEPARTMENT OF CHILDREN AND FAMILIES
Agency for Persons with Disabilities
RULE NOS.:RULE TITLES:
65G-7.001Definitions
65G-7.002Authorization for Medication Administration and Informed Consent
65G-7.0025Self-Administration of Medication without Supervision
65G-7.003Medication Administration Trainer Requirements
65G-7.0033Medication Administration Training Course Curriculum Requirements
65G-7.0035Validation Trainer Requirements
65G-7.004Medication Assistance Provider Training and Validation Requirements
65G-7.005Medication Administration Procedures
65G-7.006Medication Errors
65G-7.007Storage Requirements
65G-7.008Documentation and Record Keeping
65G-7.009Off-site Medication Administration
NOTICE 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. 44 No. 245, December 19, 2018 issue of the Florida Administrative Register.
65G-7.001 Definitions.
The terms and phrases used in this chapter shall have the meanings defined below:
(1) through (33) No change.
(34) “Self-administration of medication without supervision” means that the client is capable of self-administering his or her s their own medications without any supervision, monitoring, verbal prompting, physical assistance, or cuing from staff.
(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.
(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.
(37)(36) “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.
(38)(37) “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.
(39)(38) “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.
(40)(39)“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.
(41)(40)“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.
(42)(41) “Waiver Support Coordinator” or “WSC” means a Support Coordinator as defined in s. 393.063(41), F.S.
Rulemaking authority 393.501, 393.506 F.S. Law Implemented 393.506 F.S. History–New 3-30-08, Amended ________________.
65G-7.002 Authorization for Medication Administration and 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, PA, or APRN on an “Authorization for Medication Administration,” APD Form 65G-7.002 A, effective April 2019December 2018, incorporated here by reference, which may be obtained at ________________.
(a) through (b) No change.
(2) No change.
(3) A MAP shall will limit his or her assistance to the minimum necessary to ensure proper administration or supervised self-administration of the medication while preserving the client’s independence.
(4) The requirements of this Chapter do not apply to the following:
(a) Health care practitioners whose professional licenses include administration of medication, except all health care practitioners who provide medication assistance to Agency clients must ensure the medication administration related documentation requirements attached to Agency clients are maintained pursuant to this Chapter to ensure the safety and welfare of the clients. This includes the use of the following forms in cases where the client is served by both MAPs and licensed health care practitioners:
1. The Authorization for Medication Administration, pursuant to subsection (1);
2. A medication administration record to document any medications given as instructed in Rule 65G-7.008, F.A.C. The health care practitioner may utilize the Medication Administration Record Form, APD Form 65G-7.008 A 65G7-00, as adopted in Rule 65G-7.008, F.A.C.;
3. The Off-Site Medication Form, APD Form 65G-7.009 A, as adopted in Rule 65G-7.009, F.A.C.;
4. The Medication Destruction Record, APD Form 65G-7.007 A form APD 65G7-06, as adopted in Rule 65G-7.007, F.A.C.;
5. The Medication Error Report, APD Form 65G-7.006 A form APD 65G7-05, as adopted in Rule 65G-7.006, F.A.C.;
6. The Controlled Medication Count Form, APD Form 65G-7.007 B APD Form 65G7-007, adopted in Rule 65G-7.007, F.A.C.;
(b) Client family members or friends who provide medication assistance without compensation, as permitted by Section 464.022(1), F.S.;
(c) Providers 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 (except as referenced in (a), above) under Chapter 400, Part III, hospices (except as referenced in (a), above) regulated under Chapter 400, Part IV, health care service pools (except as referenced in (a), above) regulated through Chapter 400, Part IX, F.S., or providers 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 described in Rule 7.0025, F.A.C., except as pertains to storage of medications as outlined in Rule 65G-7.007, F.A.C.
Rulemaking Authority 393.501, 393.506 FS. Law implemented 393.506 FS. History–New 3-30-08, Amended,_____________.
Subsection (1) of this rule adopts and incorporates the Authorization for Medication Administration, APD Form 65G-7.002 A. This form has been amended to remove the phrase “by a validated medication assistance provider or licensed healthcare professional” throughout the document. The form is also amended to add “for which the client is fully capable of self-administration without supervision (specify route)” to clarify instances where a client may self-administer medications without assistance. In addition, the form effective date in the footer has been updated.
65G-7.0025 Self-Administration of Medication Without Supervision
A client who is authorized by his or her health care practitioner to self-administer medication without the supervision of a MAP or a licensed or authorized nurse, as set forth in the Authorization for Medication Administration Form, APD Form 65G-7.002 A, adopted in Rule 65G-7.002, F.A.C., may do so. Any provider who helps the client may do so by making the medication available and reminding the client to take his or her own medications at appropriate times. This does not negate the requirement that the client be capable of self-administering his or her own medications without any supervision, monitoring, verbal prompting, physical assistance, or cuing from staff. Medications for the self-administering client may be stored pursuant to Rule 65G-7.007, F.A.C., and the entire container of medications provided to the client at the appropriate time(s), without further assistance. A pill organizer (also known as “pill minder” or “pill box”) may be utilized by a client who self-administers without supervision; however the client must fill the pill organizer without any supervision, monitoring, verbal prompting, physical assistance, or cuing from staff. MAPs may not transfer the medications from the original container to any other container.
Rulemaking Authority 393.501, 393.506 F.S. Law Implemented 393.506 F.S. History–New_____________.
65G-7.003 Medication Administration Trainer Requirements.
(1) through (3) No change.
(4) Approved Trainers shall:
(a) No change.
(b) Utilize standard course curriculum provided by the Agency for all medication administration training and prescribed enteral formula administration training, with the exception of providers utilizing previously approved web-based curriculums as of July 1, 2018. Such web-based providers may continue to utilize those web-based courses, so long as the curriculum continues to meet curriculum standards as set forth in Rule 65G-7.0033, F.A.C. Otherwise, the Agency-provided curriculums are the only course curriculums that may be utilized for training MAP applicants. Failure to teach the curriculum to the Agency standards and requirements as set forth in Rule 65G-7.0033, F.A.C. shall subject the trainer’s approval to disciplinary action, including and up to revocation of approval;
(c) through (g) No change.
(h) Maintain a copy of a training roster for each course provided, including a list of attendees, and a list of attendees who successfully completed the course, beginning on July 1, 2019. These documents must be maintained for at least two years.
(5) All Trainers must attend:
(a) An Initial Training providing an overview of Chapter 65G-7, F.A.C., provided by a Regional Office MCM before the application to provide medication administration training is approved. Locations and information on how to attend this training can be obtained from the Regional Office. Contact information for each Regional Office may be found at www.apdcares.org/locations;
(b) An Annual Update Training course provided by a Regional Office MCM, which is due no later than December 31st June 30th of each year. Trainers approved within 6 months prior to December 31st June 30th may forego taking the annual update until the year following the year the Trainer is initially approved.
(6) through (7) No change.
(8) The Agency shall may deny a Trainer’s application for failure to comply with the application or eligibility requirements or for any of the following:
(a) through (d) No change.
(9) Failure to comply with Chapter 393.506, F.S., or any provision of Chapter 65G-7, F.A.C., shall subject the Trainer’s approval to disciplinary action, including use of a corrective action plan, suspension, or revocation of the Trainer’s approval. If revoked, the Trainer shall may not subsequently be approved to provide medication administration training or prescribed enteral formula administration training. The Agency may take action against a Trainer’s approval if the Trainer fails to comply with Chapter 393.506, F.S., or Chapter 65G-7, F.A.C., including any of the following actions or omissions:
(a) through (p) No change.
(10)Training Certificates:
(a) No change.
(b) Certificate Requirements for MAP Applicants:
1. Upon successful completion of the Basic Medication Administration examination, the Trainer shall issue the examinee a completed Certificate of Completion for Basic Medication Administration Training, APD Form 65G-7.003 B, effective December 2018, adopted and incorporated herein, which may be obtained at ______________. The Certificate shall contain the name of the Trainer, the Agency-assigned Trainer Number, date(s) of course administration, name of the examinee, and the signature of the Trainer. Upon successful completion of the validation by simulation and the course exam, the Trainer shall issue the examinee a partially completed Basic Medication Administration Validation Certificate, APD Form 65G-7.003 C, effective April 2019December 2018, adopted and incorporated herein, which may be obtained at ______________. This Validation Certificate Form shall reflect the examinee’s successful completion of the validation by simulation only and may not be issued prior to the successful completion of the exam.
2. Upon successful completion of the Prescribed Enteral Formula Medication Administration examination, the Trainers shall issue the examinee a completed Prescribed Enteral Formula Administration Certificate of Completion, APD Form 65G-7.003 DC, effective April 2019 December 2018, adopted and incorporated herein, which may be obtained at_______________.
3. The Certificate(s) shall contain the following:
a. Trainer’s name and Trainer Number;
b. Trainer’s nursing license number and date of expiration
c. Date(s) of course;
d. Name of the student; and
e. Signature of Trainer.
4. Trainers shall not substitute a different form for the certificate forms listed in paragraph (10)(b).
Rulemaking Authority 393.501, 393.506 F.S. Law Implemented 393.506 F.S. History–New 3-30-08, Amended __________.
Subparagraph (10)(b)1. of this rule adopts and incorporates the Basic Medication Administration Validation Certificate, APD Form 65G-7.003 C. This form has been amended to add the “Primary Route Validation Trainer must validate these skills:” above the box where the skills are listed. The form effective date has also been corrected.
Also, subparagraph (10)(b)2. of this rule adopts and incorporates the Prescribed Enteral Formula Administration Certificate of Completion, APD Form 65G-7.003 C. This form number has been amended to 65G-7.003 D. The form effective date has also been corrected.
65G-7.0033 Medication Administration Training Course Curriculum Requirements
(1) No change.
(2) Basic Medication Administration course curriculum requirements:
(a) through (b) No change.
(c) Web-Based course curriculum requirements: Basic Medication Administration Trainers may provide the Agency course via web-based distance learning if the course complies with the following curriculum requirements in addition to the requirements provided for in subparagraphs (2)(a) and (2)(b):
1. The course taught must:
a. Demonstrate:
i. Interactivity between the student and course provider within 24 hours;
ii. How interactivity promotes student involvement, and
iii. That the course measures learning and addresses comprehension of content at regular intervals;
b. Monitor student enrollment, participation, and course completion;
c. Provide for in-person simulation of routes as indicated in 65G-7.004, F.A.C.;
d. Be able to satisfactorily demonstrate that stated course hours (minimum of 6) are consistent with the actual course hours spent by the student to complete the course;
e. Assure qualified instructors will be available to answer questions and provide students with necessary support during the course; and
f. Require that the student complete a statement at the end of the course indicating that he or she personally completed each module/session of instruction.
2. A Trainer may make minor changes to the format but not the content of the Agency-provided curriculum or exams that are provided with the Agency curriculum when developing a web-based course, so long as the changes have been approved by the Agency;
3. To meet the requirements for competency in otic, transdermal, and topical medication simulation set forth in s. 393.506(2)(a), F.S., the Validation Trainer may supervise the simulation for the completion of the initial training under written instruction from the Medication Administration Course Trainer for web-based courses only.
(3) No change.
Rulemaking Authority 393.501, 393.506 F.S. Law Implemented 393.506 F.S. History–New __________.
65G-7.0035 Validation Trainer Requirements
(1) through (6) No change.
(7) The Agency shall may deny a Validation Trainer’s application for failure to comply with application or qualification requirements or for any of the following:
(a) through (d) No change.
(8) Failure to comply with Section 393.506, F.S., or any provision of Chapter 65G-7, F.A.C., shall subject the Validation Trainer’s approval to disciplinary action, including use of a corrective action plan, suspension, or revocation of the Validation Trainer’s approval. If revoked, the Validation Trainer shall may not subsequently be approved to provide validation training. The Agency shall may take action against a Validation Trainer’s approval for any of the following actions or omissions:
(a) through (j) No change.
(9) Training Certifications:
(a) Certificate Requirements for Validation Trainers: Upon successful completion of the initial overview, the Agency shall issue the Validation Trainer a completed Certificate of Completion. Validation Trainers who have successfully completed the initial overview must maintain the original Certificate indicating successful completion and provide it to the Agency upon request.
(b) Certificate Requirements for MAP Applicants:
1. Upon successful completion of the on-site validation, the Validation Trainers shall complete the Basic Medication Administration Validation Certificate, APD Form 65G-7.003 C 65G-7.003 B, effective April 2019 December 2018, as adopted and incorporated in Rule 65G-7.003, F.A.C.
2. Upon successful completion of the on-site validation completed during the Prescribed Enteral Formula Administration validation, the Validation Trainers shall issue the examinee a completed Prescribed Enteral Formula Administration Validation Certificate, APD Form 65G-7.0035 B, effective December 2018, adopted and incorporated herein, which may be obtained at ______________.
3. The Certificate(s) shall contain the following:
a. Medication Administration Trainer’s name and Trainer Number;
b. Validation Trainer’s name, Trainer Number, and signature;
c. Validation Trainer’s nursing or physician licensing number and date of expiration;
d. Date(s) of validation(s);
e. Name of the student; and
f. All routes validated.
4. Validation Trainers shall not substitute a different form for the certificate forms listed in paragraph (8)(b).
5. If the Validation Trainer provides subsequent validations for a MAP who has previously been validated on other routes, the Validation Trainer shall document the subsequent successful validations on the MAP’s original Validation Certificate, in the space provided.
Rulemaking Authority 393.501, 393.506 F.S. Law Implemented 393.506 F.S. History–New ___________.
65G-7.004 Medication Assistance Provider Training and Validation Requirements.
(1)(a) No change.
(b) Unless otherwise authorized by law in the State of Florida, individuals who are not currently recognized by the Agency as a MAP permitted to administer prescribed enteral formulas or supervise the self-administration of prescribed enteral formulas to Agency clients are prohibited from doing so. MAPs or other unlicensed direct service providers administering prescribed enteral formulas who have previous training in the administration of prescribed enteral formula at the time this rule becomes effective shall have until December 31, 2019 180 days from the effective date of the rule to obtain the training and validation required to continue administering prescribed enteral formulas to clients, during which time they may continue to administer prescribed enteral formulas.
(2) through (3) No change.
(4) Validation Requirements:
(a) Any MAP who is has already been successfully validated for otic, transdermal, or topical routes on the effective date of these rules is not required to become revalidated for those three routes, unless the validation for the MAP’s primary route lapses. Any MAP who is validated holds a current validation for administration routes other than otic, transdermal, or topical routes, may obtain validation for these three routes via on-site validation from the Validation Trainer by either simulation or with an actual client using the client’s medication.
(b) through (e) No change.
(5) Successful assessment and validation require that the applicant demonstrate his or her capability to correctly administer medication and supervise the self-administration of medications in a safe and sanitary manner in an on-site client-setting using the client’s prescribed medications, except for the simulated routes, which include otic, transdermal, and topical administration routes.
(a) Validation for Basic Medication Administration includes a demonstration of the following proficiencies:
1. The ability to comprehend and follow medication instructions on a prescription label, physician’s order, and properly complete a MAR form;
2. The ability to administer medication by oral, transdermal, ophthalmic, otic, rectal, enteral, inhaled, or topical administration routes;
3. The ability to obtain pertinent medication information, including the purpose of the medication, its common side effects, and symptoms of adverse reactions to the medication, either from the package insert that comes from the pharmacy, or other professionally recognized medication resource, and to maintaining this information for easy access and future reference;
4. The ability to write legibly, convey accurate information, and communicate with Agency staff and other health care providers through the applicant’s writings in a manner that ensures the health, safety, and well-being of the clients;
5. The ability to comply with medication administration record-keeping requirements;
6. The ability to communicate in a manner that permits health care providers and emergency responders to adequately and quickly respond to emergencies,
7. Knowledge of the proper storage and handling of medications;
8. Knowledge of proper disposal of expired or unused medications;
9. Knowledge of special requirements relating to storage and disposal of controlled medications;
10. Knowledge of requirements for obtaining authorizations for medication administration assistance, authorization for self-administration of medication without supervision, and informed consent for medication administration assistance; and
11. Adequate Training on the correct positioning and use of any adaptive equipment or use of special techniques required for the proper administration of medication.
(b) Validation for Prescribed Enteral Formula Administration includes a demonstration of the following proficiencies:
1. The ability to comprehend and follow prescribed enteral formula instructions on a physician’s order and properly complete a MAR form;
2. The ability to administer prescribed enteral formula by the enteral administration route;
3. The ability to write legibly, convey accurate information, and comply with medication administration record-keeping requirements;
4. The ability to communicate in a manner that permits health care providers and emergency responders to adequately and quickly respond to emergencies;
5. Knowledge of the proper storage and handling of prescribed enteral formulas;
6. Adequate training on the correct positioning and use of any adaptive equipment or use of special techniques required for the proper administration of prescribed enteral formulas.
(c) Subsequent validations for additional routes may be completed by the MAP following his or her initial validation(s). If the MAP obtains a subsequent validation, he or she must ensure that the Validation Trainer documents the subsequent validation(s) on the MAP’s original Validation Certificate, in the space provided.
(6) To maintain his or her ability to administer or supervise the self-administration of medication, a MAP must attend an Update Training Course and be revalidated annually, subject to the following qualifications:
(a) Update Training Course (referred to as Annual Inservice Training in s. 393.506, F.S.):
1. MAPs that administer or supervise self-administration of medications must attend an annual update training course in Basic Medication Administration provided by the Agency, prior to the expiration of their current validation. Upon successful completion of the Basic Medication Administration annual update, the MAP shall receive a Certificate of Completion for Basic Medication Administration Annual Update, APD Form 65G-7.004 A, effective December 2018, adopted and incorporated herein, which may be obtained at ______________.
2. MAPs that administer or supervise self-administration of prescribed enteral formulas must attend an annual update training course in Prescribed Enteral Formula Administration provided by the Agency prior to their re-validation. This course is required in addition to the Basic Medication Administration annual update training course. Upon successful completion of the Prescribed Enteral Formula Administration annual update, the MAP shall receive a Certificate of Completion for Prescribed Enteral Formula Administration Annual Update, APD Form 65G-7.004 B, effective December 2018, adopted and incorporated herein, which may be obtained at ______________.
3. MAPs who are required to re-validate on or before October 15, 2019 within the first 60 days following the effective date of this rule are permitted to complete the re-validation without completing the Update Training Course prior to re-validation.
(b) Re-Validation Requirements:
1. Effective and Expiration Dates:
a. Primary routes
i. The effective date of a MAP’s primary route validation is the date that the MAP successfully completed the initial validation for that route.
ii. The expiration date for his or her primary route validation is based on the date of his or her initial validation received for a primary route of medication administration. The validation for the primary route of medication administration expires annually on the anniversary date of his or her initial effective date.
b. All other routes, except otic, transdermal, and topical routes
i. The effective date of a MAP’s non-primary route(s), except otic, transdermal, and topical routes, is the date of the most recent validation for that specific route, regardless of when the MAP successfully completed the initial validation for that specific route.
ii. The expiration date for a MAP’s non-primary route(s), except otic, transdermal, and topical routes, is one year from the date of the most recent validation.
c. Otic, Transdermal, and Topical Routes
i. The effective date of a MAP’s otic, transdermal, and topical routes is the date that the MAP successfully completed the initial validation by simulation or with an actual client.
ii. Otic, transdermal, and topical routes do not expire.
2. through 7. No change.
(7) A MAP may only assist in the administration of medication through an administration route for which the MAP holds a current, active validation.
(a) When a client is prescribed a medication requiring an administration route for which the MAP has not yet been validated or for which his or her validation has expired, the MAP must obtain a validation for that specific administration route before administering the medication to the client via that route.
(b) Temporary Emergency Validation
1. When a client is prescribed a medication requiring an administration route for which the MAP has not been validated, the MAP may obtain a temporary an emergency validation for only that specific administration route and only that specific client from any individual licensed or authorized to practice nursing in the State of Florida pursuant to Ch. 464, F.S., or licensed to practice medicine as a physician in the State of Florida pursuant to Chs. 458 or 459, F.S., if:
a. The prescribed medication is necessary to ensure the health and safety of the client;
b. The MAP or the MAP’s supervisor attempts and is unable to contact a MAP who is able to administer the medication at the appropriate dosage times and who is validated for the specific administrative route;
c. The MAP obtains a validation in that administration route from an Agency-approved Validation Trainer as soon as possible within 30 days of the date the temporary emergency validation was signed by the medical professional;
d. The nurse or physician documents the validation either utilizing Temporary Emergency Validation Form, Form 65G-7.004 C, effective April 2019 December 2018, adopted and incorporated herein, which may be obtained at _____________________, or utilizing a document with the nurse or physician’s letterhead on it indicating:
i. That the nurse or physician validated the MAP;
ii. The date of validation;
iii. The route of administration validated;
iv. The length of time the validation is necessary in order to ensure the client obtains the medication as prescribed and to provide time for the MAP to either obtain a validation from an Agency-approved Validation Trainer or locate a MAP who is validated in the appropriate administration route to provide the medication. Under no circumstances shall a Temporary an Emergency Validation last longer than 30 days from the date of validation.
2. If the doctor or nurse utilizes a form with the nurse or physician’s letterhead on it rather than the Temporary Emergency Validation Form, the document utilized to record the Temporary Emergency Validation must be attached to the Temporary Emergency Validation Form. Completed Temporary Emergency Validation forms must be maintained by the MAP and his or her employer and be available to the Agency for review upon request.
3. A Temporary An Emergency Validation can only be obtained for the following routes:
a. Oral;
b. Enteral, except for prescribed enteral formulas;
c. Transdermal;
d. Ophthalmic;
e. Otic;
f. Rectal;
g. Inhaled; and
h. Topical.
(c) No change.
(8) through (10) No change.
Rulemaking Authority 393.501, 393.506 F.S. Law Implemented 393.506 F.S. History–New 3-30-08, Amended _______________.
Sub-subparagraph (7)(b)1.d. of this rule adopts and incorporates the Emergency Validation Form, APD Form 65G-7.004 C. This form has been retitled the “Temporary Validation Form.” The form effective date has also been corrected.
65G-7.005 Medication Administration Procedures.
(1) through (10) No change.
(11) If a MAP violates any provision of s. 393.506, F.S., or this Chapter, the Agency shall may:
(a) Prohibit the MAP from providing medication administration services to clients of the Agency;
(b) Request the MAP:
1. Successfully complete the Basic Medication Administration Course and corresponding validation;
2. Successfully complete the Prescribed Enteral Formula Administration Course and corresponding validation;
3. Participate in and successfully complete a corrective action plan; and
4. Comply with remediation requests.
(12) If a MAP or licensed health care practitioner violates any provision of s. 393.506, F.S., or this Chapter within an Agency-licensed residential facility, the Agency shall may take such actions as set forth in Chapter 65G-2, F.A.C. against the residential facility where the MAP or licensed health care practitioner is providing services as is necessary to ensure the health, safety, and welfare of the Agency’s clients and third parties.
(1213) Any person, including licensed health care practitioners, who in good faith renders emergency care or treatment in violation of this chapter, either in direct response to emergency situations related to and arising out of a public health emergency declared pursuant to s. 381.00315, F.S., a state of emergency which has been declared pursuant to s. 252.36, F.S., or at the scene of an emergency outside of a hospital, doctor’s office, or other place having proper medical equipment, without objection of the injured victim or victims, shall not be held responsible for the administrative violation as a result of such care or treatment where the person acts as an ordinary reasonably prudent person would have acted under the same or similar circumstances.
Rulemaking Authority 393.501, 393.506 F.S. Law Implemented 393.506 F.S. History–New 3-30-08, Amended __________.
65G-7.006 Medication Errors.
(1) No change.
(2) Immediately following an error as listed in subsection (1), the MAP, licensed health care practitioner, or facility administrator must take the following steps:
(a) Notify supervisory personnel;
(b) In the case of administration of a wrong medication, a wrong dosage, or the provision of medication to the wrong client, immediately notify the client’s health care practitioner, observe the client closely for a minimum period of 60 minutes after the medication was administered or self-administration was supervised, or for as long as directed by the health care practitioner, and immediately report any observed changes in the client’s condition to the prescribing health care practitioner, and call 911 to request emergency services if the client exhibits respiratory difficulty or other potentially life-threatening symptoms;
(c) For all errors listed in subsection (1), with the exception of paragraphs e, f, g, h, and j, notify the client’s prescribing health care practitioner of the error, and if there is no licensed health care professional present, request that the practitioner prepare and electronically transmit via fax or secure email a medication directive addressing the error to the client’s home, facility, or pharmacy, and document the client’s health care practitioner’s response or lack of response; and
(d) Fully document all observations and contacts made regarding a medication error in a “Medication Error Report,” APD Form 65G-7.006 A, effective April 2019 December 2018, incorporated herein by reference, which may be obtained at ___________. The MAP or licensed health care practitioner shall place a copy of the Report in the client’s file. It is permissible to use an alternate Medication Error Report form generated by an electronic system, provided that the alternate electronic form collects all the information required and collected on the Agency form.
(3) through (5) No change.
(6) If an Agency MCM determines that the medication error justifies corrective action, including, but not limited to additional training, the Regional Office will notify the MAP, licensed health care practitioner, or his or her supervisor in writing of the necessary corrective action plan, including a specific and reasonable timeframe for completion of the corrective action plan. If the MAP or licensed health care practitioner fails to comply with the corrective action plan, the Agency may take action against:
(a) The MAP’s validation, including and up to prohibiting the MAP from providing medication administration services; or
(b) The provider’s residential facility license, and
(c) The provider’s Medicaid Waiver Services Agreement.
Rulemaking Authority 393.501, 393.506 F.S. Law Implemented 393.506 F.S. History–New 3-30-08, Amended ________.
Paragraph (2)(d) of this rule adopts and incorporates the Medication Error Report, APD Form 65G-7.006 A. This form has been amended to add a box for Legal representative refused medication for client in the Type of Medication Error Involved box at the bottom of page 1. The form’s effective date has also been corrected.
65G-7.007 Storage Requirements.
(1) MAPs and licensed health care practitioners must observe the following medication storage requirements:
(a) No change.
(b) Destroy any prescription medication that has expired per the pharmacist’s label or the label provided by the manufacturer on OTC medications, or is no longer prescribed and document the medication disposal on a “Medication Destruction Record,” APD Form 65G-7.007 A, effective April 2019 December 2018, incorporated herein by reference, which may be obtained at ___________________. The MAP or licensed health care practitioner must sign the Record before a third-party witness;
(2) through (4) No change.
(5) Controlled medication storage requires the following additional safeguards:
(a) The controlled medications must be stored separately from other prescription and OTC medications in a locked container within a locked enclosure.
(b) For facilities operating in shifts, a MAP or licensed health care practitioner must perform controlled medication counts for each incoming and outgoing personnel shift, as follows:
1. The medication count must be performed by a MAP or licensed health care practitioner and witnessed by another MAP or licensed health care practitioner,
2. Both providers must verify count accuracy by documenting the amount of medication present and comparing that amount to both the previous count and number of doses administered between counts,
3. The providers must record the medication count on a “Controlled Medication Form.” The Agency provides two versions of the form, one with dates provided, and one where the providers may fill in the dates manually. The dated version of the Controlled Medication Count Form, APD Form 65G-7.007 B1, effective April 2019 December 2018, incorporated herein. may be obtained at _________________. The undated version of the Controlled Medication form, APD Form 65G-7.007 B2, effective December 2018, incorporated herein. may be obtained at _________________. The MAP or licensed health care practitioner must sign and date the form verifying the count; and
4. Immediately document and report any medication discrepancies to the facility supervisor.
(c) For facilities with only one MAP or licensed health care practitioner per shift, the MAP or licensed health care practitioner must conduct, document, and sign a daily medication count on the Controlled Medication Form; and
(d) For facilities with no shifts, the MAP or licensed health care practitioner who is responsible for medication administration must conduct, document, and sign a controlled medication count at least once each day on the Controlled Medication Form, using the same counting and documentation technique described in subparagraph (5)(c)(4)(c).
Rulemaking Authority 393.501, 393.506 F.S. Law Implemented 393.506 F.S. History–New 3-30-08, Amended ____________.
Paragraph (1)(b) of this rule adopts and incorporates the Medication Destruction Record, APD Form 65G-7.007 A. This form has been amended to provide that each form is client specific, providing a place for the client’s name at the top of the page, and removing a column for client names to be added.
Also, subsparagraph (5)(b)3. Of this rule adopts and incorporates the dated version of the Controlled Medication Form, APD Form 65G-7.007 B1 and the undated version of the Controlled Medication Form, APD Form 65G-7.007 B2. The undated version, APD Form 65G-7.007 B1, has been substantively rewritten and restructured to include a count down form and accountability form, in one version rather than in two. The new form does not provide separate columns for individual shifts to document the medication counts. The title has been changed to Controlled Medication Count Form and the form number has been changed to 65F-7.007 B.
The dated version of the Controlled Medication Form, APD Form 65G-7.007 B2 has been removed from the language and is no longer being incorporated by reference.
In addition, the form numbers and effective date in the footers of the forms have been updated.
65G-7.008 Documentation and Record Keeping.
(1) The MAP and licensed health care practitioner shall maintain an up-to-date MAR for each client requiring assistance with medication administration, except when the client is off-site. The MAP and licensed health care practitioner must document the administration of medication or supervision of self-administered medication immediately on the MAR. The MAP and licensed health care practitioner may utilize the Agency’s Medication Administration Record Form, APD Form 65G-7.008 A, effective April 2019 December 2018, adopted and incorporated by reference herein, which may be obtained at ____________________, or on an alternative MAR form that includes the following information:
(a) The client’s name;
(b) Any client food or medication allergies;
(c) The name of each medication prescribed for the client;
(d) The medication strength (e.g., 5mg/ tsp);
(e) The prescribing health care practitioner for each medication;
(f) The date that the medication was ordered and any date the medication was changed (including D/C date);
(g) Prescribed dosage for each medication;
(h) Scheduled time of administration for each medication;
(i) Prescribed route of administration for each medication;
(j) Prescribed instructions for crushing, mixing or diluting of specific medications, if applicable;
(k) The dates each medication was administered;
(l) The initials and signature of the MAP or licensed health care practitioner who administered or supervised the self-administration of medications;
(m) A record of any medication dosage refused or missed, documented by the MAP or licensed health care practitioner responsible for administering the scheduled dosage, by drawing a circle around the appropriate space on the MAR form and initialing it; and
(n) The reasons for not administering a medication, annotated and initialed by the MAP or licensed health care practitioner in the comments section on the MAR form using the following system, or a comparable numbering and coding system containing the same information: 1 – home, 2 – work, 3 – ER/hospital, 4 – refused, 5 – medication not available (explain on back of MAR form), 6 – held by MD (explain on back of MAR), 7 – other (explain on back of MAR).
(2) through (5) No change.
Rulemaking Authority 393.501, 393.506 F.S. Law Implemented 393.506 F.S. History–New 3-30-08, Amended _____________.
Subsection (1) of this rule adopts and incorporates the Medication Administration Record Form, APD Form 65G-7.008 A. This form has substantially restructured and amended to provide more room for the prescribers’ names, on page 1, a medication row was removed to maximize writing space, and on page 2, the “reason medication is not administered” box was removed to correspond to amendments made to rule language.
65G-7.009 Off-site Medication Administration.
(1) If a client who has his or her medications administered to him or her or who is supervised with self-administration of medication will be away from a licensed residential facility or supported living home and requires assistance with medications during that time by persons other than the MAP or licensed health care practitioner, the MAP or licensed health care practitioner must comply with the following requirements to assure that the client has appropriate medications during his or her absence:
(a) Provide an adequate amount of medication for administration of all dosages the client will require while away;
(b) Perform a count of the medication amounts provided to the client for administration during the absence and a second count of the medication amounts received upon the client’s return;
Paragraph (1)(b) of this rule adopts and incorporates the Off-Site Medication Form, APD Form 65G-7.009 A. This form has been amended to provide a place for the individual who is returning the client and medications to sign upon the return of the medications, and for all signing individuals to print their names. In addition, the form effective date in the footer has been updated.
Document Information
- Related Rules: (12)
- 65G-7.001. Definitions
- 65G-7.002. Determining Need for Assistance; Informed Consent Requirement
- 65G-7.0025. Self-Administration of Medication without Supervision
- 65G-7.003. Medication Administration Training Course
- 65G-7.0033. Medication Administration Training Course Curriculum Requirements
- More ...