(A)
Purpose
This rule sets forth requirements for
the medication administration information system database, documentation of
performance of health-related activities and administration of medication,
compliance and quality assessment, and actions that may be taken by the
department regarding certification issued pursuant to Chapter 5123-6 of the
Administrative Code.
(A)(B) Medication
administration information system database
(1)
The department shall
will operate and maintain the medication
administration information system database of registered nurse instructors and
registered nurse trainers holding valid certification issued in accordance with
rule 5123:2-6-04
5123-6-04 of the Administrative Code and developmental
disabilities personnel holding valid certification issued in accordance with
rule 5123:2-6-06
5123-6-06 of the Administrative Code in health-related
activities and prescribed medication administration, prescribed medication
administration through feeding
gastrostomy and
jejunostomy tube by nursing delegation, and subcutaneous injection
administration of insulin and medication for the treatment
of metabolic glycemic disorders by nursing delegation.
(2) The department shall
will provide
read and write access to the medication administration information system
database to all registered nurse instructors. Each registered nurse instructor
shall
will
enter in the database initial information about each person he or she
registered
nurse the registered nurse instructor trained to be a registered nurse
trainer in accordance with rule 5123:2-6-04
5123-6-04 of the Administrative Code.
(3) The department shall
will provide
read and write access to the medication administration information system
database to all registered nurse trainers. Each registered nurse trainer
shall
will
enter in the database current information about developmental disabilities
personnel he or she
the registered nurse trainer trained in accordance
with rule 5123:2-6-06
5123-6-06 of the Administrative Code at the time
of certification and recertification of the developmental disabilities
personnel.
(4)
Each registered nurse trainer shall
Registered nurse trainers will enter in the medication
administration information system database
,
information about himself or herself at the time of recertification and
thereafter, within sixty calendar days of any change of information. Each
registered nurse trainer shall enter information required for renewal of his or
her registered nurse trainer certification prior to expiration of the
certification.
:
(a)
Information about
themselves at the time of their recertification and thereafter, within sixty
calendar days of any change of information.
(b)
Information
required for renewal of their registered nurse trainer certification prior to
expiration of the certification.
(5) The department shall
will provide
read only access to the medication administration information system database
to the public.
(B)(C) Documentation of
performance of health-related activities and administration of prescribed
medication by developmental disabilities personnel
(1) All prescribed medication administered
pursuant to this chapter shall
will be administered according to the written
directions of a licensed health professional authorized to prescribe drugs and
according to the training received by developmental disabilities personnel in
accordance with rule 5123:2-6-06
5123-6-06 of the Administrative Code.
(2) Performance of health-related activities
and administration of prescribed medication and treatments
shall
will be
documented in a medication/treatment administration record indicating the
completion of prescribed orders, including the signature or initials of the
developmental disabilities personnel administering the prescribed medication or
treatment, date, time, and when appropriate, observations or difficulties
noted. This written documentation is required for all prescribed medication and
treatments performed, administered, missed, held, or
refused
declined,
including:
(a) Routine and as-needed
prescribed medication and treatments;
(b) Health-related activities; and
(c)
Subcutaneous
injections
Administration of insulin and
subcutaneous injections of prescribed medication
for the treatment of metabolic glycemic disorders.
(3) Medication/treatment administration
records
shall
will include at a minimum:
(a) Name of individual served;
(b) All allergies of individual
served;
(c) Day, month, and year of
documentation;
(d) Name of drug or
treatment;
(e) Complete dosage and
frequency of prescribed medication;
(f) Route of prescribed medication
administration;
(g)
Scheduled/prescribed time or intervals for administration;
(h) Any special instructions regarding each
medication administration or treatment as provided by the pharmacy, physician,
or prescriber; and
(i) Parameters
provided by the physician or licensed health professional for ordered
health-related activities.
(4) The employer of developmental
disabilities personnel shall
will maintain a means of identifying signatures
and initials of developmental disabilities personnel making entries in the
medication/treatment administration record. Identification
shall
will be
included in the medication/treatment administration record or by using a
separate master signatures/initials log.
(5) Certified developmental disabilities
personnel transcribing any information in a medication/treatment administration
record or checking the accuracy of information transcribed in the
medication/treatment administration record
shall
will document
when transcription and/or check has been completed, including date, time, and
signature or initials.
(a) Only a licensed
nurse or developmental disabilities personnel with health-related activities
and prescribed medication administration certification may transcribe
information in a medication/treatment administration record or check the
accuracy of information transcribed in the medication/treatment administration
record.
(b) Checking the accuracy
of transcriptions
shall
will include:
(i) Verifying changes are transcribed as
specified by the prescriber;
(ii)
Verifying special instructions are indicated as instructed by pharmacy or
prescriber directives; and
(iii)
Ensuring the availability of equipment and/or supplies required to administer
medication or perform the task in the setting.
(6) With any change to medication and/or
treatment orders, the employer of developmental disabilities personnel or
delegating nurse shall
will ensure the medication/treatment
administration record has been checked.
(7) Employers of developmental disabilities
personnel and independent providers shall
will ensure documentation, including the date,
time, and signature or initials of certified developmental disabilities
personnel who sign the medication/treatment administration record is completed
in accordance with this rule.
(C)(D) Requirements for
developmental disabilities personnel to report medication/treatment errors
(1) Any medication/treatment error
by developmental disabilities personnel in
the performance of health-related activities,
administration of oral prescribed medication, or administration of
topical prescribed medication that results
in physical harm to the individual shall
will be immediately reported to an appropriate
licensed health care professional. The requirement to immediately report
medication/treatment errors applies to errors involving prescribed medication,
treatments, over-the-counter medication, and health-related
activities.
(2) Any
medication/treatment error
by developmental
disabilities personnel shall
will be
reported in accordance with rule
5123-17-02 of the Administrative
Code when the medication/treatment error meets the definition of major unusual
incident or unusual incident.
(3)
All medication/treatment errors
shall
will be documented in an unusual incident report
in accordance with rule
5123-17-02 of the Administrative
Code. Developmental disabilities personnel who observe, identify, or become
aware of a medication/treatment error
shall
will report to the delegating nurse and/or
supervisory staff immediately in accordance with the employer's written policy
and procedure.
(4) The employer of
developmental disabilities personnel shall
will train developmental disabilities personnel
in accordance with the employer's written policy and procedure that
medication/treatment errors and related plans of prevention
shall
will be
documented in an unusual incident report.
(D)(E) Compliance and
quality assessment
(1) Each county board
shall
will
employ or enter into a contract with a registered nurse instructor or a
registered nurse trainer who will serve as a quality assessment registered
nurse to assist with consultation and quality assessment oversight.
(2) Quality assessment reviews
shall
will be
conducted when certified developmental disabilities personnel perform
health-related activities, administer oral prescribed medication, administer
topical prescribed medication, administer topical over-the-counter
musculoskeletal medication, administer oxygen, or administer metered dose
inhaled medication for individuals who:
(a)
Receive services from certified supported living providers;
(b) Receive residential support services from
certified home and community-based services providers, if the services are
received in a community living arrangement that includes not more than four
individuals;
(c) Receive adult
services in a setting where sixteen or fewer individuals receive services;
and
(d) Reside in residential
facilities of five or fewer beds, excluding intermediate care facilities for
individuals with intellectual disabilities.
(3) The quality assessment registered nurse
shall
will
complete quality assessment reviews so that a review of each provider location
in the county where certified developmental disabilities personnel perform
health-related activities, administer oral prescribed medication, administer
topical prescribed medication, administer topical over-the-counter
musculoskeletal medication, administer oxygen, or administer metered dose
inhaled medication is conducted at least once every three years. The quality
assessment registered nurse may conduct more frequent reviews if the quality
assessment registered nurse, county board, provider, or department determines
there are issues to warrant such.
(4) Quality assessment reviews
shall
will be
completed in a format prescribed by the department.
(5) Quality assessment reviews
shall
will
include, but are not limited to:
(a)
Observation of performance of health-related activities and administration of
prescribed medication;
(b) Review
of the system of communication and supports related to performance of
health-related activities and administration of prescribed medication for the
provider location being assessed to ensure complete and accurate administration
of health care directives given by health care professionals for the
individuals being served at the provider location;
(c) Review of documentation of performance of
health-related activities and administration of prescribed medication for
completeness of documentation and for documentation of appropriate actions
taken based on parameters provided in the health-related activities and
prescribed medication administration training program described in rule
5123:2-6-06
5123-6-06 of the Administrative Code;
(d) Review of all medication/treatment errors
from the past twelve months; and
(e) Review of the system of processes and
procedures used by the employer of developmental disabilities personnel or
independent provider to monitor and document completeness and correct
techniques used during performance of health-related activities, administration
of oral prescribed medication, and administration of topical prescribed
medication.
(6) The
quality assessment registered nurse shall
will evaluate for patterns of failure to comply
or maintain compliance with this chapter.
(7) The quality assessment registered nurse
shall
will
provide a copy of the quality assessment review report to the county board and
the provider of services within ten business days of the quality assessment
review. The quality assessment review report shall
will identify
findings specific to provisions of this chapter and may recommend to the county
board and the provider of services steps to be taken to improve the systems and
procedures used by the provider to support the functioning of the trained
developmental disabilities personnel and suggestions for improving quality
related to performance of health-related activities and administration of
prescribed medication and maintaining compliance with this chapter.
(8) The quality assessment registered nurse
shall
will
maintain a copy of each quality assessment review he
or she performs
performed in accordance
with paragraph (D)(3)
(E)(3) of this rule.
(9) The quality assessment registered nurse
shall
will
coordinate with, as applicable, the county board, the employer of developmental
disabilities personnel, or independent provider to ensure that safety concerns
are immediately addressed.
(10) The
employer of developmental disabilities personnel or the independent provider,
as applicable, shall
will submit a written plan of improvement to the
quality assessment registered nurse that addresses specific rule violations
identified in the quality assessment review within thirty calendar days of
receipt of the quality assessment review report.
(11) The quality assessment registered nurse
shall
will
notify the county board and the department when the employer of developmental
disabilities personnel or the independent provider fails to:
(a) Submit a written plan of improvement
within sixty calendar days of receipt of the quality assessment review report;
or
(b) Successfully implement the
written plan of improvement within sixty calendar days of submission of the
plan to the quality assessment registered nurse.
(12) The quality assessment registered nurse
shall act
will
serve as a resource for the county board and providers of services
concerning health management issues and may assist in expanding health care
services in the community.
(E)(F) Prohibition on
performance of health-related activities and administration of prescribed
medication by developmental disabilities personnel
(1) If an employer of developmental
disabilities personnel believes or is notified by the county board, the
department, a delegating nurse, or the quality assessment registered nurse that
developmental disabilities personnel have not or will not safely perform
health-related activities or administer prescribed medication, the employer
shall
will
prohibit the action from continuing or commencing. Developmental disabilities
personnel shall
will not engage in the action or actions subject to an
employer's prohibition.
(2) When
the employer prohibits the action from continuing or commencing, the employer
shall
will:
(a) Notify the developmental disabilities
personnel of the prohibition and immediately make other staffing arrangements
so that the needs of individuals served are met in a manner that ensures
compliance with the requirements of this chapter;
(b) Immediately notify the department by
making a notation regarding the prohibition of the developmental disabilities
personnel in the medication administration information system
database;
(c) If applicable,
immediately notify the county board via the major unusual incident reporting
system in accordance with rule
5123-17-02 of the Administrative
Code; the county board, as applicable,
shall
will notify the
quality assessment registered nurse; and
(d) If applicable, immediately notify the
delegating nurse.
(3) The
employer shall
will ensure corrective action is taken prior to
allowing the developmental disabilities personnel to resume the performance of
health-related activities or the administration of prescribed
medication.
(4) The employer
shall
will
notify the department by making an entry regarding the corrective action and
end of prohibition of the developmental disabilities personnel in the
medication administration information system database and, as applicable, the
county board, the quality assessment registered nurse, and/or the delegating
nurse of the corrective action taken.
(F)(G) Denial, suspension,
or revocation of certification issued
under
pursuant to this chapter
(1) The department may deny, suspend, or
revoke a certificate holder's certification issued
under
pursuant to
this chapter for good cause including:
(a)
Misfeasance;
(b)
Malfeasance;
(c)
Nonfeasance;
(d) Substantiated
abuse or neglect;
(e) A violation
of sections 5123.41 to
5123.45 of the Revised Code or
rules adopted under
pursuant to this chapter;
(f) The conviction or plea of guilty to a
disqualifying offense as set forth in paragraph (E) of rule
5123-2-02 of the Administrative
Code and the corresponding exclusionary period has not elapsed;
(g) Other conduct the department determines
to be injurious to individuals being served; or
(h) The board of nursing has taken
disciplinary action against a certificate holder under
pursuant to
Chapter 4723. of the Revised Code.
(2) When denying, suspending, or revoking
certification under
pursuant to this rule, the department
shall
will
comply with the notice and hearing requirements of Chapter 119. of the Revised
Code and section 5123.452 of the Revised
Code.
(G)(H) Procedures for
accepting complaints and conducting investigations
(1) Any complaint regarding the performance
of health-related activities or administration of prescribed medication by
developmental disabilities personnel pursuant to the authority granted
under
pursuant
to section 5123.42 of the Revised Code or
compliance with rules adopted under
pursuant to this chapter
shall
will be
made to a county board or the department. This paragraph
shall
will
not be construed to allow developmental disabilities personnel, a
representative of developmental disabilities personnel, or an employee
organization as defined in Chapter 4117. of the Revised Code to make a
complaint to a county board or the department regarding a personnel
action.
(2) Any complaints related
to the scope of nursing practice shall
will be referred to the Ohio board of
nursing.
(3) Any complaints
regarding registered nurses related to training of developmental disabilities
personnel shall
will be referred to the department.
(4)
The department
may conduct an audit of a registered nurse's training of developmental
disabilities personnel to determine compliance with rule
5123-6-06 of the Administrative
Code.
(4)(5) When a quality
assessment registered nurse receives a complaint or identifies concerns based
on a quality assurance
assessment review conducted pursuant to paragraph
(D)
(E) of
this rule related to the performance or qualifications of developmental
disabilities personnel, the quality assessment registered nurse
shall
will
conduct an initial investigation which shall
include
includes a discussion with the
developmental disabilities personnel and his or
her
the employer. After completing the
initial investigation, the quality assessment registered nurse
shall
will
contact and work with the department's designee to ensure that the cases are
handled in a consistent manner statewide.
(H)(I) Immunity from
liability
Developmental disabilities personnel who perform health-related
activities or administer medication pursuant to the authority granted
under
pursuant
to section 5123.42 of the Revised Code and
rule 5123:2-6-03
5123-6-03 of the Administrative Code are not liable
for any injury caused by performing the health-related activity or
administering the medication when:
(1)
The developmental disabilities personnel acted in accordance with the methods
taught in training completed in compliance with section
5123.42 of the Revised Code and
rules 5123:2-6-05 and 5123:2-6-06
5123-6-05 and 5123-6-06 of the Administrative
Code; and
(2) The developmental
disabilities personnel did not act in a manner that constitutes wanton or
reckless misconduct.
(I) Authority of director to suspend
provisions of this rule
During the COVID-19 state of
emergency declared by the governor, the director may suspend quality assessment
reviews described in paragraph (D) of this rule.
Notes
Ohio Admin. Code
5123-6-07
Effective:
1/14/2024
Five Year Review (FYR) Dates:
10/30/2023 and
01/14/2029
Promulgated
Under: 119.03
Statutory
Authority: 5123.04,
5123.45,
5123.46
Rule
Amplifies: 5123.04,
5123.41 to
5123.47,
5126.36
Prior
Effective Dates: 09/30/1993 (Emer.), 12/29/1993, 05/16/1994 (Emer.),
08/06/1994, 06/30/1995, 02/14/2000, 10/22/2003 (Emer.), 01/08/2004, 06/01/2016,
11/06/2017, 06/11/2020 (Emer.), 11/19/2020