The purpose of these rules is to create standards for unlicensed direct care services staff to provide services to clients in transitional living facilities to administer medications. These rules will create standards for medication administration ...

 

AGENCY FOR HEALTH CARE ADMINISTRATION

Health Facility and Agency Licensing

RULE NOS.:RULE TITLES:

59A-17.125Administration of Medications to Clients by Unlicensed Direct Care Service Staff

59A-17.126Training and Validation Required for Unlicensed Direct Care Service Staff

PURPOSE AND EFFECT: The purpose of these rules is to create standards for unlicensed direct care services staff to provide services to clients in transitional living facilities to administer medications. These rules will create standards for medication administration training and validation of the completion of training requirements.

SUMMARY: The creation of these rules will provide standards for unlicensed direct care services staff who provide services to clients in transitional living facilities who administer prescribed, prepackaged and premeasured medications after the completion of a training in medication administration and under the supervision of a registered nurse. These rules will create standards for medication administration training and validation of the completion of training requirements.

SUMMARY OF STATEMENT OF ESTIMATED REGULATORY COSTS AND LEGISLATIVE RATIFICATION: The Agency has determined that this will not have an adverse impact on small business or likely increase directly or indirectly regulatory costs in excess of $200,000 in the aggregate within one year after the implementation of the rule. A SERC has not been prepared by the Agency.

The Agency has determined that the proposed rule is not expected to require legislative ratification based on the statement of estimated regulatory costs or if no SERC is required, the information expressly relied upon and described herein: No SERC was prepared, the Agency prepared a checklist for each rule to determine the necessity for a SERC.

Any person who wishes to provide information regarding a statement of estimated regulatory costs, or provide a proposal for a lower cost regulatory alternative must do so in writing within 21 days of this notice.

RULEMAKING AUTHORITY: 400.9977 FS.

LAW IMPLEMENTED: 400.9977 FS.

IF REQUESTED WITHIN 21 DAYS OF THE DATE OF THIS NOTICE, A HEARING WILL BE HELD AT THE DATE, TIME AND PLACE SHOWN BELOW:

DATE AND TIME: March 28, 2016, 2:30 p.m. ‒ 4:00 p.m.

PLACE: Agency for Health Care Administration, 2727 Mahan Drive, Building 3, Conference Room C, Tallahassee, FL 32308

THE PERSON TO BE CONTACTED REGARDING THE PROPOSED RULE IS: Jacqueline Williams, Agency for Health Care Administration, 2727 Mahan Drive, Mail Stop #33, Tallahassee, FL 32308 or via email at [e-mail]

 

THE FULL TEXT OF THE PROPOSED RULE IS:

 

59A-17.125 Administration of Medications to Clients by Unlicensed Direct Care Service Staff

(1) It is the responsibility of the licensee to ensure that individual unlicensed direct care service staff (UDC) who will be administering medication to clients meet all requirements of this rule.

(2) UDC may administer only prescribed, prepackaged, premeasured oral, topical nasal, and ophthalmic medications.

(3)  UDC may administer over the counter (OTC) medications as currently prescribed by the client’s health care professional.

(4) UDCs may not:

(a) Administer medications by injection including intramuscular, intravenous or subcutaneous;

(b) Administer medication vaginally or rectally; or

(c)  Conduct glucose monitoring.

(5) UDCs may administer medications to a client only after the following requirements are met for that client:

(a) A current informed consent has been signed by the client or client’s representative. The consent must acknowledge and permit UDCs to administer specifically listed medications prescribed by a licensed health care professional to the client. The informed consent must be updated and signed at least annually;

(b) A written report for the client that indicates the client’s behavior and any past medication reactions must be documented on the Medication Administration Record (MAR). The written report and MAR must be updated if the client’s behavior or medication reactions change. Information included in the written report can be provided by the client or client’s representative, or another UDC or direct care staff person who is familiar with the client. The person administering medications must be familiar with the information included in the written report and MAR prior to administering medications to clients; and

(c) A determination is made that the client to whom medication will be administered has not been deemed capable of self-administration of his or her medications. The determination is to be made by the facility through assessment and interdisciplinary team (IDT) review.

(6) Administration of medication by UDCs must be under the supervision of a registered nurse or ARNP.

(a) Supervision includes weekly monitoring of medication and 24-hour availability of a registered nurse or ARNP via telephone or paging device.

(b) Prior to assigning tasks to a UDC, the supervisory nurse must verify the training and validation of the unlicensed direct care service staff as required by this Rule Chapter.

(c) The supervisory nurse must communicate the assignment to the UDC and verify that the UDC understands the assignment.

(d) Monitoring and supervision of the completion of the assignment must be documented by the supervising nurse.

(e) The supervising nurse must participate in performance evaluations of the UDC relative to performance of medication administration.

(7) Requirements governing acquiring, receiving, dispensing, administering, disposing, labeling, and storage of medication by UDCs include:

(a) Outdated medication must be properly destroyed by the supervising nurse. The disposal will be witnessed by one other staff of the facility and a record of the medication disposal must be maintained by the facility and signed by the supervising nurse and witness.

(b) Torn, damaged, illegible or mislabeled prescription labels should be reported immediately to the dispensing pharmacy or pharmacist.

(c) Clients must not miss the administration of medications due to delays in refilling a prescription. It shall be the responsibility of the supervising nurse to ensure that refills are ordered and obtained in a timely manner.

(d) No client shall be administered a prescription or OTC medication or treatment, except upon the written order of the client’s prescribing health care professional.

(8) When administering medications to clients; the UDC must:

(a) Wash his or her hands with soap and water prior to administration of medication, or supervising the self-administration of medication to clients. They must also wash their hands between the administration of medication to each client and when there is a change in route of administration.

(b) Prepare medications for one individual client at a time in a quiet location that is free from distraction.

(c) Administer medications to one client at a time. To complete a client’s medication process, the medication of one client must be returned to the portable or permanent medication storage unit and documentation made in the MAR before administering medications to, or supervising the self-administration of, medication for another client.

(d) Administer medications to each client, at the time, with the dosage, and by the route prescribed by the client’s health care professional. Each time medication is administered:

1. Conduct a triple-check of the dosage and time of administration against the original medication container label and the MAR before administering or supervising the self-administration of the medication;

2. Confirm the client to whom the medication is to be administered is the same client for whom the medication has been prescribed or ordered;

3. Administer as prescribed and via the route instructed by the client’s prescribing health care professional;

4. Do not crush, dilute or mix medications without written directions or instructions from the client’s prescribing health care professional.

5. Check the expiration date before administering each medication. Medications with an expiration date preceding the current date must not be administered.

6. Facilitate the correct positioning and use any adaptive equipment or techniques required for that client for the proper administration of medications.

(e) Ensure the oral medication administered or supervised during self-administration has been completely ingested before leaving the client. Directly observe the client for a period of at least twenty minutes following the administration of a new medication ordered by the client’s prescribing health care professional. This observation period is to immediately detect and react to possible side effects of the medication or to document the effectiveness of the medication. UDCs must review the MAR for special instructions regarding required observation of medications and the UDC must monitor for side effects and effectiveness of all administered drugs.

(f) Immediately record the administration of the medication in the MAR.

Rulemaking Authority 400.9977(4), F.S., Law Implemented 400.9977, F.S., History–New_______.

 

59A-17.126 Training and Validation Required for Unlicensed Direct Care Service Staff

(1) Required medication administration training must include criteria to ensure that competency is demonstrated through validation of the qualification of the unlicensed direct care services staff (UDC) and all requirements of UDC specified in this Rule Chapter.

(2) Medication administration training will be conducted by a registered nurse, ARNP or physician for UDCs and will be provided by the transitional living facility (TLF) licensee. Any person providing medication administration training sessions or conducting skills validation tests must first complete a trainer orientation session, which includes requirements of this rule and information to be covered during medication administration training sessions. Documentation of the trainer’s completed orientation will be provided to each UDC that he or she trains or validates.

(3) Medication administration training must include the following topics:

(a) Basic knowledge and skills necessary for medication administration charting on the Medication Administration Record (MAR);

(b) Roles of the physician, nurse, pharmacist and direct care staff in medication supervision;

(c) Procedures for recording/charting medications;

(d) Interpretation of common abbreviations used in the administration and charting of medications;

(e) Knowledge of facility medication systems;

(f) Safety precautions used in medication administration;

(g) Methods and techniques of medication administration;

(h) Problems and interventions in the administration of medications;

(i) Observation and reporting of anticipated side effects, adverse effects and desired positive outcome; and

(j) Each duty of UDCs as required in this Rule Chapter.

(4) Validation of the effective completion of the training is required for each UDC to assess that competency has been achieved after completion of required training. To become validated, the UDC must be able to successfully demonstrate, in a practical setting, his or her ability to correctly administer or supervise the self-administration of medications to clients in a safe and sanitary manner and to correctly and accurately document actions related to the administration of medications, in accordance with the requirements of this Rule Chapter. At completion of the training, a UDC must attain an overall score of 100% on knowledge tests that cover the training and facility specific questions. The UDC will have three attempts to achieve a 100% score.  If after the third attempt a score of 100% is not achieved, the UDC must repeat the training and may not administer medication to clients until such time as a score of 100% is achieved. Additionally, a UDC must be able to state the purpose, common side effects, and signs and symptoms of adverse reactions for a list of commonly used medications from memory or demonstrate how they obtain that information and maintain it for easy access.

(5) Validation of competency will be conducted by an RN, physician, or ARNP. The TLF licensee will maintain documentation containing the following information:

(a) The name and address of the validator;

(b) Validation date, with expiration date of 365 days from the validation;

(c) Printed name and signature of the validating health care professional as it appears on his or her license; and

(d) Validating health care professional’s license number, with license expiration date.

(6) All training curricula, handouts, testing materials, and documents used to comply with the medication administration training and skills requirements of this rule will be kept on file for five years in the TLF.

(7) The following must be validated for each UDC:

(a) Demonstration of the ability to read and follow medication instructions on a prescription label, physician’s order or MAR;

(b) Demonstration of the ability to write legibly, complete required documentation, and convey accurate and discernible information;

(c) Demonstration of the ability to perform as required in this Rule Chapter; and

(d) Demonstration of the ability to state the purpose, common side effects, and signs and symptoms of adverse reactions for a list of commonly used medications from memory or demonstrate how they obtain that information and maintain it for easy access.

(8) UDCs and the TLF licensee must maintain a copy of the UDC’s current skills validation document, and documentation of orientation for their medication administration trainer and validator. UDCs are responsible for maintaining a copy of these documents and providing copies to the TLF, if requested.

(9) If requested, a UDC will have available a copy of their signed skills validation documentation to provide to the client or client’s representative. UDCs will also have available, if requested, a copy of their annual skills revalidation documentation, within five working days of the revalidation date.

(10) UDCs who have not successfully renewed their validation prior to the expiration date will not be eligible to administer medications to clients until medication administration retraining and revalidation of skills have been successfully completed.

Rulemaking Authority 400.9977(4), F.S., Law Implemented 400.9977, F.S., History–New_______.

 

NAME OF PERSON ORIGINATING PROPOSED RULE: Jacqueline Williams

NAME OF AGENCY HEAD WHO APPROVED THE PROPOSED RULE: Elizabeth Dudek

DATE PROPOSED RULE APPROVED BY AGENCY HEAD: February 12, 2016

DATE NOTICE OF PROPOSED RULE DEVELOPMENT PUBLISHED IN FAR: October 27, 2015