Section 5123-6-07 - General provisions and compliance for performance of health- related activities and administration of prescribed medication(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.
(B) Medication administration information system database(1) The department 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 5123-6-04 of the Administrative Code and developmental disabilities personnel holding valid certification issued in accordance with rule 5123-6-06 of the Administrative Code in health-related activities and prescribed medication administration, prescribed medication administration through gastrostomy and jejunostomy tube by nursing delegation, and administration of insulin and medication for the treatment of metabolic glycemic disorders by nursing delegation.(2) The department will provide read and write access to the medication administration information system database to all registered nurse instructors. Each registered nurse instructor will enter in the database initial information about each registered nurse the registered nurse instructor trained to be a registered nurse trainer in accordance with rule 5123-6-04 of the Administrative Code.(3) The department will provide read and write access to the medication administration information system database to all registered nurse trainers. Each registered nurse trainer will enter in the database current information about developmental disabilities personnel the registered nurse trainer trained in accordance with rule 5123-6-06 of the Administrative Code at the time of certification and recertification of the developmental disabilities personnel.(4) Registered nurse trainers will enter in the medication administration information system database: (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 will provide read only access to the medication administration information system database to the public.(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 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 5123-6-06 of the Administrative Code.(2) Performance of health-related activities and administration of prescribed medication and treatments 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 declined, including:(a) Routine and as-needed prescribed medication and treatments;(b) Health-related activities; and(c) Administration of insulin and subcutaneous injections of prescribed medication for the treatment of metabolic glycemic disorders.(3) Medication/treatment administration records 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 will maintain a means of identifying signatures and initials of developmental disabilities personnel making entries in the medication/treatment administration record. Identification 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 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 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 will ensure the medication/treatment administration record has been checked.(7) Employers of developmental disabilities personnel and independent providers 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.(D) Requirements for developmental disabilities personnel to report medication/treatment errors (1) Any medication/treatment error in the performance of health-related activities or administration of medication that results in physical harm to the individual 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 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 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 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 will train developmental disabilities personnel in accordance with the employer's written policy and procedure that medication/treatment errors and related plans of prevention will be documented in an unusual incident report.(E) Compliance and quality assessment(1) Each county board 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 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 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 will be completed in a format prescribed by the department.(5) Quality assessment reviews 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 5123-6-06 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 will evaluate for patterns of failure to comply or maintain compliance with this chapter.(7) The quality assessment registered nurse 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 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 will maintain a copy of each quality assessment review performed in accordance with paragraph (E)(3) of this rule.(9) The quality assessment registered nurse 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, 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 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 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.(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 will prohibit the action from continuing or commencing. Developmental disabilities personnel 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 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, will notify the quality assessment registered nurse; and(d) If applicable, immediately notify the delegating nurse.(3) The employer 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 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.(G) Denial, suspension, or revocation of certification issued pursuant to this chapter (1) The department may deny, suspend, or revoke a certificate holder's certification issued pursuant to this chapter for good cause including: (d) Substantiated abuse or neglect;(e) A violation of sections 5123.41 to 5123.45 of the Revised Code or rules adopted 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 pursuant to Chapter 4723. of the Revised Code.(2) When denying, suspending, or revoking certification pursuant to this rule, the department will comply with the notice and hearing requirements of Chapter 119. of the Revised Code and section 5123.452 of the Revised Code.(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 pursuant to section 5123.42 of the Revised Code or compliance with rules adopted pursuant to this chapter will be made to a county board or the department. This paragraph 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 will be referred to the Ohio board of nursing.(3) Any complaints regarding registered nurses related to training of developmental disabilities personnel 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.(5) When a quality assessment registered nurse receives a complaint or identifies concerns based on a quality assessment review conducted pursuant to paragraph (E) of this rule related to the performance or qualifications of developmental disabilities personnel, the quality assessment registered nurse will conduct an initial investigation which includes a discussion with the developmental disabilities personnel and the employer. After completing the initial investigation, the quality assessment registered nurse will contact and work with the department's designee to ensure that the cases are handled in a consistent manner statewide.(I) Immunity from liability Developmental disabilities personnel who perform health-related activities or administer medication pursuant to the authority granted pursuant to section 5123.42 of the Revised Code and rule 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 5123-6-05 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. 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