BEFORE THE DEPARTMENT OF PUBLIC

HEALTH AND HUMAN SERVICES OF THE

STATE OF MONTANA

 

In the matter of the adoption of New Rule I and amendment of 37.34.114 pertaining to certification of persons assisting in the administration of medication

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NOTICE OF PUBLIC HEARING ON PROPOSED ADOPTION AND AMENDMENT

 

TO:  All Concerned Persons

 

            1.  On June 13, 2012, at 10:00 a.m., the Department of Public Health and Human Services will hold a public hearing in Room 207 of the Department of Public Health and Human Services Building, 111 North Sanders, Helena, Montana, to consider the proposed adoption and amendment of the above-stated rules.

 

2.  The Department of Public Health and Human Services will make reasonable accommodations for persons with disabilities who wish to participate in this rulemaking process or need an alternative accessible format of this notice.  If you require an accommodation, contact Department of Public Health and Human Services no later than 5:00 p.m. on June 6, 2012, to advise us of the nature of the accommodation that you need.  Please contact Kenneth Mordan, Department of Public Health and Human Services, Office of Legal Affairs, P.O. Box 4210, Helena, Montana, 59604-4210; telephone (406) 444-4094; fax (406) 444-9744; or e-mail dphhslegal@mt.gov.

 

3.  The rule as proposed to be adopted provides as follows:

 

            NEW RULE I  CERTIFICATION OF PERSONS ASSISTING IN THE ADMINISTRATION OF MEDICATION: ADOPTION OF THE MEDICATION ADMINISTRATION MANUAL  (1)  For the purpose of certification of persons who supervise or assist in the administration of medication to persons through the state- sponsored developmental disabilities services, the department has developed and published an instructional and reference aid entitled Health and Medication Administration Manual for Individuals with Developmental Disabilities: A Self-Paced Study Guide and Reference Manual, published and effective October 1, 2009.  The department adopts and incorporates by reference this manual.  Copies may be obtained from the Department of Public Health and Human Services, Developmental Disabilities Program, P.O. Box 4210, Helena, MT 59604.

 

AUTH:  53-20-204, MCA

IMP:     53-20-204, MCA

 

4.  The rule as proposed to be amended provides as follows, new matter underlined, deleted matter interlined:

 

            37.34.114  CERTIFICATION OF PERSONS ASSISTING IN THE ADMINISTRATION OF MEDICATION  (1)  This rule establishes criteria and procedures under which an employee or an agent of a contractor provider of developmental disabilities services responsible for the delivery of direct care may receive certification to assist and supervise an individual a person in state-sponsored developmental disabilities services in taking prescribed medication.

            (2)  Assistance and supervision may only be given where a medication which is normally self-administered has been prescribed for an individual the person and where the physician medical professional who prescribed the medication also prescribed assistance or supervision in the administration of the medication.

            (2) (3)  For the purposes of this rule, the following definitions apply:

            (a)  "Assistance" means providing any degree of support or aid to an individual a person who independently performs at least one component of medication-taking behavior; and.

            (b)  "Supervision" means critically observing and directing an individual a person engaged in medication-taking behavior.

            (3) (4)  An agent or employee or an agent of a contractor provider, in order to assist or supervise in the administration of prescribed medication to individuals persons, must be certified by the department as herein provided unless the agent or employee or the agent is otherwise authorized by law to provide such assistance or supervision.

            (4) (5)  To be certified, an employee or agent of a contractor provider must demonstrate knowledge of health issues relating to persons with developmental disabilities including general health, health emergencies, aspiration pneumonia, seizure disorders, and knowledge of the use and side effects of medications by achieving a score of at least 90% 85% on a comprehensive test administered by the department.

            (5) (6)  Application for certification to provide supervision and assistance in the administration of medication is made by providing notification submitting a request to be certified to the Department of Public Health and Human Services, Developmental Disabilities Program, P. O. Box 4210, Helena, MT  59604.

            (6) (7)  Any contractor provider may receive, free of charge, an instructional and reference aid entitled Seizure Disorders and Medications, a self-paced instructional manual Health and Medication Administration Manual for Individuals with Developmental Disabilities: A Self-Paced Study Guide and Reference Manual as adopted by the department in [New Rule I].

            (7) (8)  The department, or an agency determined by the department, administers the comprehensive test to a qualified applicant within 30 days of receipt of the notification of application request for certification.

            (8) (9)  Notice of certification or noncertification is mailed by the department within 10 ten days of the date of testing.  The A notice of certification designates an effective date and an expiration date for the certification.  Certification is approved for The certification period may be for no more than a maximum of 2 two years.

            (9) (10)  A person may receive consecutive certification by retaking the test as provided in (4) (5) through (7) (8).

            (10) (11)  Every contractor Each provider shall maintain a current list of contractor employees and agents certified to supervise and assist in the administration of medication.

            (11) (12)  If an individual a person has been receiving developmental disabilities services for 30 days and supervision and assistance is to be administered for more than 10 ten consecutive days, this activity must be included as an objective in the written individual plan of care.  To address the objective, an individual program plan must be prepared which describes a program to train the individual person to self-administer the medication and must specify at least:

            (a)  the target medication-taking behavior;

            (b)  the conditions under which such behavior should occur;

            (c)  the conditions under which such behavior will be trained;

            (d)  the criterion for completion of the individual program plan in accordance with (13) (14) herein;

            (e)  the written strategies for training the target behavior;

            (f)  a data recording system which accounts for each prescribed medication dosage; and

            (g)  a daily data recording system which specifies progress or lack of progress toward the target behavior.

            (12) (13)  Every instance of assistance or supervision provided under this rule must be recorded and must include at least the name of the person who receives medication, the name of the person who assists or supervises the taking of medication, the date and time the medication was taken, and the type of medication taken.

            (13) (14)  An individual A person is considered to be capable of self-administering medication when it has been documented that the individual person has self-administered all (100%) of prescribed medication dosages for a consecutive 30-day period.

            (14) (15)  There are two conditions under which an individual program plan to teach self-administration of medication is no longer necessary.  They are:

            (a)  the individual person has met the criterion specified in (13) (14);, or

            (b)  the IP planning team has reviewed the ongoing implementation of the individual program plan and found that the individual person has reached the maximum level of independence in the self-administration of medication of which the individual is currently capable.  In making this decision, the team must evaluate whether:

            (i)  the individual person has made any progress;

            (ii)  the program has been consistently implemented;

            (iii)  a variety of teaching strategies has been employed;

            (iv)  the decision to discontinue the program will interfere with the individual's person's ability to be served in a less restrictive environment; and

            (v)  the program has been in place long enough to make a decision concerning its effectiveness.

            (15) (16)  If the IP planning team decides that an individual program plan to teach self-administration of medication is no longer necessary, the requirements concerning the need for certified personnel and recording instances of assistance and supervision must be met.

            (16) (17)  The feasibility of re-instituting a program to teach self-administration of medication must be examined at subsequent IP meetings by the planning team.  If the individual's person's situation changes such that there is a possibility of further acquisition of the skill, a program is must be initiated.

            (17) (18)  The department may revoke or suspend a certification.

            (a)  The department may revoke certification by notifying the certified person of the reason for revocation in writing at least 10 ten days prior to the effective date of revocation.  The certified person may request, in writing, within the 10 ten days prior to revocation, a review by the division administrator of the decision.  A decision is issued within 30 days from the date the request for review is received.  When a request for a review is made, the revocation is not effective until the division administrator's decision is made review is completed and a final decision issued.

            (b)  The department may suspend a certified person's right to assist or supervise in the administration of medication certification for a period no longer than 15 days, after which the suspension must be removed or notice of revocation issued.  If notice of revocation is issued, suspension may continue until the effective date of revocation or until the division administrator's decision is made.

 

AUTH:  53-20-204, MCA

IMP:     53-20-204, MCA

 

            5.  STATEMENT OF REASONABLE NECESSITY

 

The Department of Public Health and Human Services (department) is proposing to adopt New Rule I and amend ARM 37.34.114 to update the certification of persons who supervise or assist in the administration of medication to persons through the state-sponsored developmental disabilities services.

 

New Rule I

 

The department proposes to adopt and incorporate the manual entitled "Health and Medication Administration Manual for Individuals with Developmental Disabilities: A Self-Paced Study Guide and Reference Manual," published and effective October 1, 2009.  The department received requests prior to October 1, 2009 to revise and update the manual referenced in ARM 37.34.114.  The revised manual was not incorporated by reference into rule at that time.  The department decided to complete a pilot period of the manual and the required comprehensive testing of direct-support staff.  The pilot period is complete and the manual is now being incorporated by reference.

 

Manual Changes

 

The prior edition of the manual focused primarily on seizure disorders and the medications associated with those disorders.  The changes incorporated into the revised manual for certification of employees or agents of a provider are necessary to broaden the focus beyond seizures and to accurately reflect on the skills needed by direct-support staff assisting persons with developmental disabilities. 

The direct-care staff who are employed by developmental disabilities services providers are generally required to be able to supervise or assist daily in the administration of medications prescribed for a range of additional health care needs.  In addition, the department received requests for a revised manual which would serve to effectively and more fully inform a person with a high school education.  Therefore, the department worked with provider staff, medical professionals, and others to develop the revised edition of the manual.  The revised manual includes, in addition to information on seizure disorders, information on general health care issues, emergencies, aspiration pneumonia, and other conditions.

 

The department began its pilot of the revised training manual and the comprehensive test in 2009.  Throughout the pilot period the department monitored the results.  In addition to the monitoring, the provider agencies gave feedback to the department regarding test results.  One consistent concern was the difficulty that direct-support staff encountered in reaching the 90% criterion score to pass the test.  The department extended the pilot period because it assumed that the difficulty was that the agency staff were unfamiliar with the expanded material covered in the revised manual.  However, after the pilot period it appears clear to the department that it is the wider scope of the training that is the cause of the difficulty.  The department's analysis of the test scores shows that obtaining a score of 85% fulfills the intent of the manual, which is to provide staff with an expanded knowledge base regarding medications and health issues that they encounter.  The department has decided to amend the criterion to 85%.

 

Dr. Justad, a physician contracted by the Developmental Disabilities Program (DDP), authored the revised edition of the manual.  During the research and writing of the manual, Dr. Justad consulted with:  (1) Dr William Docktor, PharmD, the author of the previous manual; (2) Becky Hornby, LPN, and LaDonna Todd Fabian, training specialist, with a developmental disabilities provider, Spring Meadows Resources; (3) Janie Lewis, the nursing supervisor at the state of Montana's ICF/MR facility, Montana Developmental Center; (4) Michelle Matson, RN, and Leslie Robertson, day services manager, with a developmental disabilities provider, AWARE, Inc.; and (5) Mike Peterson, a Quality Improvement Specialist for the Developmental Disabilities Program.  Further information was obtained from Karen McGowan, a consultant in medication practices, Ruth Givens, of the Developmental Disabilities Program in Tennessee, and the Quality Counsel, an advisory council for the DDP composed of family members, provider staff, advocates, and program staff.

 

In addition, the department consulted with the Montana Board of Nursing in the matter of the publishing of the manual.  At the request of the Montana Board of Nursing the revised manual includes the following components in medication management training:

 

1.  the list of "rights of medication administration;"

 

2.  the purposes of medications;

 

3.  the classes of medications;

 

4.  the allowable routes of administration of medications;

 

5.  the care, storage, and regulation of controlled substances and medications;

 

6.  the adverse reactions, side effects, and allergies to medications;

 

7.  the medication log; and

 

8.  medication error reporting.

 

The department considered other approaches before substantially revising the manual.  The department determined that retention of the current manual, with only the revision of the certification tests to test for broader knowledge, was not feasible.  The manual serves to instruct direct-care staffs who are required to be apprised of current medication knowledge and practices for assisting.  The previous edition of the manual, in addition to being outdated and lacking necessary breadth, was difficult to comprehend.  The revised manual contains updated information with respect to medication practices for persons with developmental disabilities.  One option the department considered was the wholesale adoption of a training curriculum manual, such as the manual in use by the State of Tennessee produced by McGowan Consultants.  This and other similar consultant manuals can be expensive, costing $50 or more per manual.  The use of these manuals would require more extensive professional-based training than is necessary for the more limited assistance authorized in Montana.

 

Revisions to the Health and Medication Administration Manual

 

A summary of the topics in the revised Health and Medication Administration Manual are as follows:

 

1.  general introductory material that explains the purpose of the manual, how to use it, and where to obtain additional information;

 

2.  the role of care givers in medication therapy;

 

3.  medication use which includes sections on the purpose of medications, explanations of generic vs. brand name medications, over-the-counter vs. prescription medications, and controlled substances;

 

4.  medication storage and how to destroy unused medications;

 

5.  dosage forms of medications;

 

6.  swallowing problems, special circumstances, topical dosage, and parenteral medications;

 

7.  monitoring of medications, new prescriptions, home medications, and PRN medications;

 

8.  pharmacy labels, general guidelines in assisting with medications which cover the seven rights of medication administration, universal precautions, safety issues, abbreviations, and documentation of assisting with medication administration including filling out medication administration records;

 

9.  rules and laws regarding medication assistance and teaching self-medication skills;

 

10.  categories of medications covering basic knowledge of analgesics, anti-infectives, psychiatric medications, and heart and respiratory medications;

 

11.  seizure disorders including causes, types, documentation, influencing factors, and treatment;

 

12.  recognizing strokes or transient ischemic attacks;

 

13.  general information regarding diabetes mellitus types 1 and 2, glucose testing, health complications of diabetes, and hypoglycemia;

 

14.  gastroesophageal reflux, choking, and constipation;

 

15.  aspiration pneumonia; and

 

16.  allergies and anaphylaxis.

 

The revised manual also covers general information that direct-care staff must learn such as Universal Precautions, PRN guidelines, home medications, safety topics, and teaching self-medication skills.  The appendices cover specific routes of administration so that staff will know how to assist a client, as well as the glossary, a dietary fiber table, and a drug classification table for staff to look up commonly prescribed medications and find information on their use and possible side effects.

 

            6.  Concerned persons may submit their data, views, or arguments either orally or in writing at the hearing.  Written data, views, or arguments may also be submitted to: Kenneth Mordan, Department of Public Health and Human Services, Office of Legal Affairs, P.O. Box 4210, Helena, Montana, 59604-4210; fax (406) 444-9744; or e-mail dphhslegal@mt.gov, and must be received no later than 5:00 p.m., June 21, 2012.

 

7.  The Office of Legal Affairs, Department of Public Health and Human Services, has been designated to preside over and conduct this hearing.

 

8.  The department maintains a list of interested persons who wish to receive notices of rulemaking actions proposed by this agency.  Persons who wish to have their name added to the list shall make a written request that includes the name, e-mail, and mailing address of the person to receive notices and specifies for which program the person wishes to receive notices.  Notices will be sent by e-mail unless a mailing preference is noted in the request.  Such written request may be mailed or delivered to the contact person in 6 above or may be made by completing a request form at any rules hearing held by the department.

 

9.  An electronic copy of this proposal notice is available through the Secretary of State's web site at http://sos.mt.gov/ARM/Register.  The Secretary of State strives to make the electronic copy of the notice conform to the official version of the notice, as printed in the Montana Administrative Register, but advises all concerned persons that in the event of a discrepancy between the official printed text of the notice and the electronic version of the notice, only the official printed text will be considered.  In addition, although the Secretary of State works to keep its web site accessible at all times, concerned persons should be aware that the web site may be unavailable during some periods, due to system maintenance or technical problems.

 

10.  The bill sponsor contact requirements of 2-4-302, MCA, do not apply.

 

 

 

/s/ Cary B. Lund                                           /s/ Anna Whiting Sorrell                            

Rule Reviewer                                             Anna Whiting Sorrell, Director

                                                                        Public Health and Human Services

           

Certified to the Secretary of State May 14, 2012.