Section 3800.188a. Medications administration training—statement of policy

(a) Scope of training proposal. Training proposals may include any audience focus such as Statewide; one geographic area of this Commonwealth such as one region, county or city; a group of facilities; a single facility; or a specific program type (such as secure detention, mental retardation, day treatment, and the like).

(b) Training methodology. Three primary options for training methodology are envisioned by the Department. The Department’s intent is to allow for a variety of training methods. Training shall be delivered through direct, face-to-face interaction. Use of video, computer or teleconference training as the sole methodology is not permitted.

(1) Train the Trainer. This method trains trainers who in turn provide training to the staff persons who will be administering medications to the children.

(2) Direct Training. This method provides direct training to the staff persons who will be administering the medications to the children.

(3) Combination. This method combines the use of both the Train the Trainer and Direct Training methods.

(c) Authorized instructors.

(1) For both the Train the Trainer method and the Direct Training method, the trainer of trainers (in the Train the Trainer method) and the direct trainer (in the Direct Training Method) shall have one of the following levels of professional development:

(i) A licensed physician.

(ii) A licensed physician’s assistant.

(iii) A registered pharmacist.

(iv) A registered nurse.

(v) A certified registered nurse practitioner.

(vi) A licensed practical nurse.

(2) The Trainer of Trainers and the direct trainer shall have experience in public speaking, teaching or staff development/training. Background experience in pediatric medicine and the provision of services to children is preferred.

(3) In the train the trainer method, the individual who is trained by the trainer of trainers (the mid-level trainer) shall meet the minimum qualifications for child care supervisor as specified in § 3800.54(d) (relating to child care supervisor) and shall be retrained by an approved training source at least every 2 years.

(d) Proposal elements. The following elements shall be contained in a proposal:

(1) Anticipated date training will be available.

(2) Targeted geographic area or program type.

(3) Training methodology (for example, Train the Trainer, Direct Training or Combination)

(4) Documentation that the trainers have the required level of professional development and experience, as specified in subsection (c) regarding authorized instructors, including a copy of the medical license, registration or certification.

(5) A detailed, descriptive outline of the training curriculum.

(6) A time schedule that describes the total time required to complete the training and each component of the training.

(7) The maximum and minimum number of students that can be accommodated in any class.

(8) A description of the teaching strategies and methods to be used.

(9) The criteria to be applied to determine successful completion of the course including testing procedures to measure the trainee’s ability in both knowledge and skill areas. Testing provisions must verify the competency of staff persons for each component area of the training including demonstration of competence.

(10) The process to be followed in awarding a certificate to validate that course work has been successfully completed. A sample certificate to be issued by the training source should be included

(11) The process to be followed to assure that each staff person who has responsibility for administering medication to children is made aware that his certification status expires and that retraining is required once every 2 years as specified in § 3800.188 (a) (relating to medications administration training).

(12) A packet of sample training materials to be used in teaching the course.

(13) The method, resources, time schedule and any sampling procedures to be employed to complete quality assurance monitoring of the effectiveness of the training. Monitoring shall include onsite direct observation and monitoring of staff persons by medically licensed/certified/registered personnel of the training source, as well as a pre- and post-evaluation.

(14) The fee for training individuals or for group training.

(15) The record system to be maintained by the training source to accurately record persons enrolled, trained, issue and expiration dates of certificates, test results, quality assurance monitoring, and other components of this section.

(e) Minimum core training content. Training content shall include the following:

(1) Instruction on reporting and observation skills. The staff person should be skilled in observing and reporting changes in physical appearance, emotional adjustment and behavioral activity. The trained person shall be knowledgeable about the reporting of significant changes to the appropriate person within the appropriate time frames and procedures.

(2) Types of medications and their effects. Staff persons should understand and be able to recognize through observation skills, the desired, unwanted (both expected and unexpected), or absence of desired effects of medications including potential medication interactions. They should understand the categories of medicine including prescription and nonprescription medicines. They should understand the difference between controlled and non-controlled medicines.

(3) Staff person responsibilities in the medication process. Staff persons who have successfully completed training should know the limits of their ability to administer medications to children. They should be able to recognize and distinguish an individual’s medication and know how to administer the proper dosage of medicine at the proper time. They should be skilled in the proper handling techniques during medication administration so that issues relating to infection control are addressed. Staff persons should know the circumstances under which they should contact the physician with questions regarding the administration of medications.

(4) Handling emergency and health-threatening situations. Staff persons should be knowledgeable with how to handle both emergency and nonemergency conditions. They need to know how to access immediate and direct response to an emergency situation such as an allergic reaction or respiratory arrest. They also need to know how to access regular medical support.

(5) Facility specific policy and procedures. Staff should have a thorough understanding of agency policies and procedures regarding medication administration.

(6) Patterns of communication and interaction within the facility and with outside sources. Staff persons will need to understand how to elicit and convey information regarding medication administration. For example, how will information about a newly prescribed medication be communicated to other staff and other key adults who have responsibility relating to the child? How will coordination of information as available from various health care providers be communicated to all involved parties including those persons who will be responsible for assuring proper administration of medication when a child is away from the facility?

(7) Administration of medication.

(i) Staff persons need to be familiar with what they can expect to receive by way of instruction from the prescribing entity and know how to request and receive necessary clarifying information if needed.

(ii) Staff persons need to understand and accept the seven ‘‘rights’’ of medication administration: right person, right medication, right dose, right route, right time, right method and right position.

(iii) Staff persons shall know the agency policy specific to the medication administration process. They shall demonstrate proper procedures for administering medications.

(iv) Staff persons shall be able to determine when a medication error has occurred and what action should be taken.

(8) Self-administration. Staff persons shall be trained in their responsibilities to support and assist the child in self-administration of medications under the requirements of § 3800.189 (relating to self-administration of medications). The staff person should demonstrate the ability and willingness to appropriately instruct the child in the name, purpose and administration of that child’s medications and actively encourage child participation in medication activities.

(9) Regulatory requirements. Staff shall understand and be able to carry out the requirements in § § 3800.181—3800.189 (relating to medications). The facility shall conduct regular monitoring of staff persons to assure compliance with the medication administration sections of the regulations.

(f) Procedure for approval.

(1) Submit four copies of the proposal to Director, Division of Licensing Regulations and Policy, Office of Licensing and Regulatory Management, 623 Health and Welfare Building, Post Office Box 2675, Harrisburg, Pennsylvania 17105-2675.

(2) The Department will provide a written response for each proposal application received. The response will either be an approval, disapproval, partial approval or a request for additional information. Rationale will be provided for any response other than an approval.

(3) Proposals approved by the Department will be approved for a specified length of time.

(4) The Department has the right to withdraw approval at any time based on evidence of violation with the conditions of the approved proposal, this section, this chapter or applicable law.

(5) Initial proposals may be submitted as of December 31, 1999, and may be submitted at any time thereafter.

(6) Resubmission of the training proposal for continued approval must be received by the Department at least 4 months prior to expiration of the current approval. If the original proposal is unchanged, a short summary of the proposal referencing the proposal already on file with the Department is sufficient for requesting continued approval.

(7) Approved training sources, who want to amend the scope, methodology, course instructor or training content of their approved proposal shall submit an amended proposal identifying any changes that are proposed.

(8) Training source applicants will be given an opportunity to submit additional information or clarifying information if needed by the Department, if additional information is needed by the Department to make a fair determination on the suitability of the application.

(9) Training may not begin until the training source has received a written approval from the Department.

The provisions of this § 3800.188a adopted January 28, 2000, effective December 31, 1999, 30 Pa.B. 545.