Current through Register Vol. 54, No.43, October 26, 2024
Section 6600.4 - Medication administration and training-statement of policy(a)Background. Section 6600.3 (relating to requirements) incorporates by reference Federal regulations for intermediate care facilities for the mentally retarded (ICFs/MR) at 42 CFR 483.400 - 483.480. This section interprets that portion of the regulations found at 42 CFR 483.460(k)(3), which reads as follows: "Unlicensed personnel are allowed to administer drugs only if state law permits." Inasmuch as the administration of drugs is within the scope of practice of nursing, the applicable State law is The Professional Nursing Law (law) (63 P. S. §§ 211-225.5). The law specifically does not prohibit home care of the sick by unlicensed persons (see section 4(1) of the law (63 P. S. § 214(1)). The State Board of Nursing interprets the home care exemption as applying to ICFs/MR that serve no more than eight individuals.(b)Purpose. This section sets forth guidelines for the administration of medications in ICF's for eight or fewer individuals with mental retardation. The guidelines were developed in consultation with the State Board of Nursing to ensure that unlicensed staff who administer medications do so safely and lawfully. Compliance with these guidelines will be considered as part of the annual licensing inspection carried out by the Department of Health, Division of Long Term Care, ICF/MR Program.(c)Applicability. This section applies to ICF's in which eight or fewer individuals with mental retardation live. For purposes of this section, the following clarifications apply:(1) A facility is a distinct, individual residential building operating as an ICF/MR, or as part of an ICF/MR.(2) Each apartment unit within an apartment building is considered a separate facility.(3) Each half of a duplex if there is physical separation between two distinct and complete living areas, is considered a separate facility.(4) A wing of a building, or an attached building unit, does not constitute a separate facility.(5) Eight or fewer individuals means the total number of individuals living at the facility and not the licensed capacity of the ICF/MR.(6) Eight or fewer individuals means the total number of individuals living at the facility, regardless of whether the individuals are currently taking medications.(d)Medications administration guidelines.(1) Prescription medications and injections of a substance not self-administered by individuals may be administered by only one of the following: (i) A licensed physician, licensed dentist, licensed physician's assistant, registered nurse or licensed practical nurse.(ii) A graduate of an approved nursing program functioning under the direct supervision of a professional nurse who is present in the facility.(iii) A student nurse of an approved nursing program functioning under the direct supervision of a member of the nursing school faculty who is present in the facility.(iv) A staff person who meets the criteria specified in paragraph (2) for the administration of oral, topical, eye and ear drop, suppository and enema prescription medications, or who meets the criteria specified in paragraph (3) for the administration of insulin injections.(2) A staff person who has completed and passed the Department of Public Welfare's (Department) Medications Administration Course may administer oral, topical, eye and ear drop, suppository and enema prescription medications.(3) A staff person who has completed and passed the Department's Medications Administration Course and who has completed and passed a diabetes patient education program within the past 12 months that meets the National Standards for Diabetes Patient Education Programs of the National Diabetes Advisory Board, 7550 Wisconsin Avenue, Bethesda, Maryland 20205, may administer insulin injections to an individual who is under the care of a licensed physician who is monitoring the diabetes.(4) Medications administration training of a staff person shall be conducted by a trainer who has completed the Department's Medications Administration Course for trainers and is certified by the Department to train staff. Licensed, certified or registered medical personnel who serve as trainers shall also complete the Department's Medications Administration Course for trainers and be certified by the Department prior to training staff.(5) Trainers may not train other individuals to become trainers.(6) Two trainers may jointly administer the Medications Administration Course, as long as both trainers are certified and sign-off on the Module Exam Data Summary Sheet and the Medications Training Verification Form.(7) The facility shall keep a copy of each trainer's training certificate issued by the Department.(8) A certified trainer may administer medications. If a trainer has a training certificate from the Department, no further documentation is required in order for the trainer to administer medications.(9) The only acceptable medication training course is the Medications Administration Course developed by the Office of Mental Retardation.(10) A staff person who administers prescription medications or insulin injections to an individual shall complete and pass the Medications Administration Course Practicum annually.(11) The facility shall keep the following documentation for each nonmedically licensed staff person who administers medication:(i) The Written Module Examination of Medications Training Manual.(ii) The Module Examination Data Summary Sheet of the Medications Training Manual.(iii) A signed and dated copy of the Training Verification Form, including the name and signature of the person who gave the training and the date and location of the training.(iv) Evidence of a percentage score of 90% or above for each of the three test sections. If the percentage score falls below 90%, for one or more of the following sections, that test section shall be retested:(v) A copy of the Practicum Summary completed within the past year.(12) Staff medications training documentation may be transferred from one agency to another. The Practicum Summary shall be completed at the new agency prior to administering medication.(13) Injections of a substance other than insulin shall be administered by medically licensed personnel specified in paragraph (1)(i)-(iii).(14) The specialized insulin administration training specified in paragraph (3) is required prior to administering insulin injections, and every 12 months thereafter. A staff person may not take the Diabetes Patient Education training and then teach other staff. Training shall be provided directly by the organization that offers the patient education program that meets the National standards.The provisions of this §6600.4 adopted September 1, 1995, effective 9/2/1995, 25 Pa.B. 3587.