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Regulations Update

Marci Pederson, RN, BSN, Nurse Educator/Consultant

F425 Pharmacy Services

This regulation was cited 27 times in 2010 in long term care facilities in South Dakota. 
This is good news for the long term care facilities in South Dakota because it was cited 37 times in 2009!

The facility may permit unlicensed personnel to administer drugs if State law permits, but only under the general supervision of a licensed nurse.

There is a lot more to the regulatory language for F425, but this month I would like to focus on the part of the regulation pertaining to facilities permitting unlicensed personnel to administer drugs if State law permits, but only under the general supervision of a licensed nurse.  South Dakota State law does permit the delegation of administration of medications as permitted in 20:48:04.01:10 and 20:48:04.01:11 from the Nurse Practice Act.

Compliance with F425 is a huge responsibility, and part of this responsibility includes compliance with the State regulations pertaining to unlicensed assistive personnel and medication administration.  Every licensed nurse who works in a facility that utilizes unlicensed assistive personnel to help administer medication needs to be familiar with the State regulations that address this.  I have put together all of the South Dakota Board of Nursing regulations pertaining to medication administration by unlicensed assistive personnel to allow for ready access to all the information in one document.  My comments about the regulations are underlined. 
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20:48:04.01:01. General criteria for delegation.  The registered nurse is responsible for the nature and quality of nursing care that a client receives under the nurse's direction.  To achieve full utilization of the services of a registered nurse or a licensed practical nurse, the licensed nurse may delegate selected nursing tasks to unlicensed assistive personnel.  Unlicensed assistive personnel may complement the licensed nurse in the performance of nursing functions but may not substitute for the licensed nurse.  Unlicensed assistive personnel may not re-delegate a delegated act.  This statement must be adhered to very carefully.  If unlicensed assistive personnel were to re-delegate a delegated act, they would be acting beyond the scope of practice.  If a negative outcome would occur because of a re-delegated act, the supervising nurse would be responsible.

A licensed nurse is accountable to practice in accordance with the scope of practice as defined in SDCL chapter 36-9. The delegating nurse is accountable for assessing a situation and making the final decision to delegate. The delegation of nursing tasks to unlicensed assistive personnel must comply with the following criteria:
(1)  The nursing task is one that a reasonable and prudent licensed nurse would find within the scope of sound nursing judgment to delegate;
(2)  The nursing task is one that, in the opinion of the delegating licensed nurse, can be properly and safely performed by unlicensed assistive personnel without jeopardizing the client's welfare;
(3)  The nursing task does not require unlicensed assistive personnel to exercise nursing judgment;
(4)  The licensed nurse evaluates the client's nursing care needs before delegating the nursing task;
(5)  The licensed nurse verifies that the unlicensed person is competent to perform the nursing task; and
(6)  The licensed nurse supervises the performance of the delegated nursing task in accordance with the requirements of §20:48:04.01:02.
Source: 21 SDR 13, effective August 7, 1994; 26 SDR 174, effective July 4, 2000.
General Authority: SDCL 13-33A-2, 36-9-21.
Law Implemented: SDCL 13-33A-1, 36-9-3, 36-9-4, 36-9-4.1, 36-9-21.
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20:48:04.01:02. Supervision. The licensed nurse shall provide supervision of all nursing tasks delegated to unlicensed assistive personnel in accordance with the following conditions:
(1)  The licensed nurse determines the degree of supervision required after considering the following:
   (a)  The stability of the client's condition;
   (b)  The competency of the unlicensed person to whom the nursing task is delegated;
   (c)  The nature of the nursing task being delegated; and
   (d)  The proximity and availability of the licensed nurse to the unlicensed person when the nursing task will be performed;
(2)  The delegating licensed nurse or another licensed nurse is readily available either in person or by telecommunication; and
(3)  If the unlicensed person is providing care in the client's home, the time interval between supervisory visits and whether the visit is conducted in person or via telecommunication is determined by the licensed nurse in accordance with § 20:48:04.01:01. The visit shall occur no less than once every 60 days to assure client safety.
Source: 21 SDR 13, effective August 7, 1994; 26 SDR 174, effective July 4, 2000.
General Authority: SDCL 13-33A-2, 36-9-21.
Law Implemented: SDCL 13-33A-1, 36-9-3, 36-9-4, 36-9-4.1, 36-9-21.
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20:48:04.01:09. Training required for delegated medication administration.  This regulation essentially says the licensed nurse may delegate the administration of medications authorized under 20:48:04.01:10 and 20:48:04.01:11 only to unlicensed assistive personnel who have a minimum of a high school education or the equivalent and who have completed the training outlined in 20:48:04.01:13 to 20:48:04.01:15.
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20:48:04.01:10. Administration of medications.  This regulation states the licensed nurse may delegate the following medication administration tasks to unlicensed assistive personnel that have successfully completed the curriculum identified in 20:48:04.01:15.
(1) Administration of scheduled medications such as "Twice a Day", "Three times a day", or "at bedtime" by oral, rectal, topical, vaginal, or inhalation route:
(2) Measuring of a prescribed amount of liquid medication or crushing a tablet for administration if the licensed nurse has calculated the dose;
(3) Administration of schedule II controlled substances listed in SDCL 34-20B-16 and 34-20B-17 which have been prescribed and labeled in a container for a specific client.
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20:48:04.01:11. Medication administration tasks that may not be routinely delegated and require written protocol.  The following are medication administration tasks that may be delegated to unlicensed assistive personnel only in accordance with § 20:48:04.01:01 – there needs to be special training and specific protocol developed before the unlicensed assistive personnel can be delegated such tasks:
(1) Administration of the initial dose of a medication that has not been previously administered to the client; and
(2) Administration of medications on an as-needed basis, including schedule II controlled substances listed in SDCL 34-20B-16 and 34-20B-17 as provided in subdivision 20:48:04.01:10
(3) A registered nurse shall develop written protocol for the instruction and training of unlicensed assistive personnel and maintain the protocol on file.
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20:48:04.01:12. Medication administration tasks that may not be delegated. The licensed nurse may not delegate the following tasks of medication administration:
(1)  Administration of schedule II controlled substances listed in SDCL 34-20B-16 and 34-20B-17 from a locked stock supply;
(2)  Administration of medications by subcutaneous, intramuscular, intradermal, or intravenous route;
(3)  Administration of medications by way of a tube inserted in a cavity of the body;
(4)  Administration of medications via inhalation route in a complex nursing situation as defined in § 20:48:01:01; and
(5)  Calculation of any medication dose.
Source: 21 SDR 13, effective August 7, 1994; 26 SDR 174, effective July 4, 2000; 28 SDR 36, effective September 18, 2001.
General Authority: SDCL 13-33A-2, 36-9-21(4).
Law Implemented: SDCL 13-33A-1, 36-9-3(2), 36-9-4(4), 36-9-4.1(2), 36-9-21(4).
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20:48:04.01:13. Approval of training program required for delegated medication administration. Medication administration may be delegated only to those individuals who have successfully completed a training program approved by the board pursuant to §20:48:04.01:14. Approval of the training program must be renewed every two years.
Source: 21 SDR 13, effective August 7, 1994.
General Authority: SDCL 13-33A-2, 36-9-21.
Law Implemented: SDCL 13-33A-1, 36-9-3, 36-9-4, 36-9-4.1, 36-9-21.
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20:48:04.01:14. Standards for approval of medication administration training programs. An institution or individual desiring to offer a training program for delegated medication administration for unlicensed assistive personnel must submit an application for approval to the board. The board may grant approval to an applicant training program upon proof that the training program meets the following requirements:
(1)  The training program is based on the training curriculum outlined in § 20:48:04.01:15 and includes no less than 16 hours of classroom instruction and an additional 4 hours of clinical or laboratory instruction;
(2)  The person teaching a training program is a registered nurse who is currently licensed as a registered nurse in South Dakota and has a minimum of two years of clinical nursing experience;
(3)  The faculty-to-student ratio does not exceed 1:8 in the clinical setting. A 1:1 ratio is required for skills performance evaluation;
(4)  Tests are developed for each unit in the curriculum, including a final test. A skills performance evaluation must be conducted;
(5)  A passing score of 85 percent is required on each unit test with an opportunity to retake each test one time. If a student fails on retake, additional instruction is required before further testing is allowed;
(6)  A completion certificate is awarded to a person who has successfully completed the training program. The certificate must include the name and location of the institution, the length of the program, the date of completion, the full name of the person who completed the program, the signature of the faculty member in charge of the course, and the date the certificate was awarded; and
(7)  Records are maintained which include documentation of the following:
   (a)  Each person enrolled in the program, including documentation of performance and the date and reason the person withdrew or the date the person failed or completed the program;
   (b)  Each faculty member teaching the program, including qualifications and nursing experience;
   (c)  The curriculum plan and revisions;
   (d)  All tests administered; and
   (e)  A list of graduates of the program who were awarded certificates and the date of the award.

The training program must submit an evaluation of the curriculum and program standards for compliance with this section to the board every two years in order to maintain approval.
Source: 21 SDR 13, effective August 7, 1994.
General Authority: SDCL 13-33A-2, 36-9-21.
Law Implemented: SDCL 13-33A-1, 36-9-3, 36-9-4, 36-9-4.1, 36-9-21.
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20:48:04.01:15. Medication administration curriculum. The training curriculum for delegated medication administration must include:
(1)  General information relevant to the administration of medications, including:
   (a)  Governmental regulations related to the practice of nursing, the administration of medication, and the storage, administration, and recording of controlled substances;
   (b)  Ethical issues;
   (c)  Terminology, abbreviations, and symbols;
   (d)  Medication administration systems;
   (e)  Forms of medication;
   (f)  Procedures and routes of medication administration;
   (g)  Medication references available;
   (h)  The role of unlicensed assistance personnel in administering medications;
   (i)  The five rights of medication administration: right patient, right medication, right dose, right time, right route; and
   (j)  Infection control policies and procedures;
(2)  An overview of the major categories of medications related to the body systems, including:
   (a)  Cardiovascular;
   (b)  Endocrine;
   (c)  Gastrointestinal;
   (d)  Integumentary;
   (e)  Musculoskeletal;
   (f)  Nervous;
   (g)  Reproductive;
   (h)  Respiratory;
   (i)  Sensory;
   (j)  Urinary; and
   (k)  Immune;
(3)  Additional instruction shall include those categories of medications relevant to the health care setting where the unlicensed person will be employed; and
(4)  Clinical or laboratory instruction for the purpose of demonstration of medication administration and evaluation of individual competence.
Source: 21 SDR 13, effective August 7, 1994; 26 SDR 174, effective July 4, 2000.
General Authority: SDCL 13-33A-2, 36-9-21.
Law Implemented: SDCL 13-33A-1, 36-9-3, 36-9-4, 36-9-4.1, 36-9-21.

Our education manger, Gwen Maag, RN, provides the medication aide course according to regulations to ensure compliance for unlicensed assistive personnel.  Please call AESS today to schedule Gwen for all of your medication aide training needs and to schedule a mock survey with me to assess for regulatory compliance.  Help your facility have the best rating possible.  The quality of resident care will improve and you will have a waiting list for admissions instead of empty beds.  

As a former health facilities senior surveyor, Marci worked at the Department of Health Office of Licensure and Certification for eight years. Marci provides Survey Preparedness Consulting designed to create a culture of constant survey preparedness by helping staff understand regulatory requirements, not just comply with them.

Contact me at mapederson@avera.org for all of your Regulatory Compliance and Survey Preparation needs.

Do the math! The facility bottom line improves when resident care continually improves.

Read more Regulations Updates. The Avera Solutions’ Blog contains writings from Marci and other Avera Education & Staffing Solutions staff and consultants.


Marci Pederson, RN, BSN

Marci Pederson, RN, BSN

As a former health facilities senior surveyor, Marci served a variety of health care facilities. Her experience includes nursing education, medical/surgical nursing, psychiatric nursing, infection control, utilization review and quality assurance.