PROPOSED RULEMAKING
STATE BOARD
OF NURSING
[ 49 PA. CODE CH. 21 ]
IV Therapy Functions for Licensed Practical Nurses
[40 Pa.B. 2276]
[Saturday, May 1, 2010]The State Board of Nursing (Board) proposes to amend §§ 21.141 and 21.145 (relating to definitions; and functions of the LPN) and to add §§ 21.145a and 21.145b (relating to prohibited acts; and IV therapy curriculum requirements), to read as set forth in Annex A. This proposal is intended to establish the requirements for licensed practical nurses to perform nursing functions involving intravenous access devices.
Effective Date
The proposed amendments will be effective upon publication of the final-form rulemaking in the Pennsylvania Bulletin.
Statutory Authority
The proposed amendments are authorized under section 17.6 of the Practical Nurse Law (63 P. S. § 667.6) (act), which authorizes the Board to establish rules and regulations for the practice of practical nursing.
Background and Need for the Amendments
The proposed amendments are necessary due to the increased utilization of peripherally inserted central catheters and other centrally inserted intravenous access devices in the patient population cared for in this Commonwealth's hospitals and health systems. In addition, patients are being transferred to long-term care facilities with increasing frequency with complex IV access devices in place. Licensed practical nurses (LPNs) in this Commonwealth are being asked to provide services to these patients. This proposal will standardize LPN practice across this Commonwealth related to IV access devices and will provide mandates for the educational program that must be provided for LPNs working with IV access devices to ensure patient safety.
Description of Proposed Amendments
§ 21.141. Definitions.
The Board proposes to add definitions of key terms used in its rulemaking regarding IV therapy. Specifically, the Board found it necessary to define the following terms: ''bolus,'' ''central venous catheter,'' ''focused assessment,'' ''IV access device,'' ''peripheral short catheter,'' ''peripheral midline catheter,'' ''peripherally inserted central catheter (PICC),'' and ''titration of IV medications.'' The definitions used are consistent with those that are generally accepted by the health care community.
§ 21.145. Functions of the LPN.
The Board proposes to amend § 21.145. The Board proposes to update the language in § 21.145(a). In addition, the Board proposes to provide specific mandates which will require an LPN to consult with an RN and members of the patient's health care team authorized to issue orders for medical therapeutic or corrective measures (a CRNP, physician, physician assistant, podiatrist or dentist) and seek guidance if the patient's care needs exceed the LPN's scope of practice, surpass the LPN's knowledge, skill or ability, or if the patient's condition becomes unstable or immediate assistance is needed. These provisions should help to ensure that LPNs do not exceed their authorized scope of practice and an LPN attempting to provide care beyond the LPN's ability does not compromise patient care.
The Board proposes to require that an LPN obtain instruction and supervision if the LPN is implementing nursing practices or procedures that are new or unfamiliar to the LPN. This provision is intended to ensure that the LPN can competently perform all practices and procedures the LPN is expected to perform.
The Board proposes to require an LPN to follow the written, established policies and procedures of the employing facility that are consistent with the act. The prior absence of such a provision has hampered the Board's ability to protect the public when an LPN has failed to conform his conduct to facility policy, creating a risk that negligence and patient harm will occur, but where no other statutory or regulatory provision has been violated.
Finally, the Board proposes to strike the current language in § 21.145(f) and (g) regarding venipuncture and IV fluids which is greatly out of date, is not consistent with the current education and on-the-job training of LPNs, and is not consistent with the current utilization of LPNs in this Commonwealth's health care facilities. The Board proposes to replace this language with new § 21.145(f) and (g).
The proposed new § 21.145(f) would provide that an LPN may only perform IV therapy acts for which the LPN possesses the knowledge, skill and ability to safely perform and shall perform these acts under direction and supervision as set forth therein. Paragraph (1) generally provides that an RN, CRNP, physician, physician assistant, podiatrist or dentist shall supervise an LPN performing IV therapy acts. Paragraph (2) allows an LPN to be under either physical presence supervision or electronic communication when the patient's condition is stable and predictable. Paragraph (3) provides for the level of supervision required if the patient's condition is not stable and predictable; in these cases, physical presence of the supervisor is required.
Section 21.145(g) provides that only LPNs who have met the education and training requirements in § 21.145b may perform IV therapy acts. The paragraphs that follow set forth the specific IV therapy acts that LPNs may perform. Notably, the proposed rulemaking does not expand LPNs scope of practice related to the insertion or removal of IV access devices, as under current regulations, § 21.145(g)(8) authorizes an LPN to insert or remove only a peripheral short catheter. The remaining enumerated functions in subsection (g) apply to all IV access devices; however, an LPN may not insert or remove any other type of IV access device.
§ 21.145a. Prohibited acts.
The Board proposes to add a new § 21.145a, which will set forth the IV therapy acts that an LPN is prohibited from performing.
§ 21.145b. IV therapy curriculum requirements.
The Board proposes to add a new § 21.145b, which will set forth the curriculum requirements that an LPN will have to complete to perform IV therapy acts as set forth in § 21.145(g). The educational component may be included in the LPN curriculum in the approved schools of practical nursing in this Commonwealth or may be stand-alone courses offered through the approved schools of practical nursing or through health care facilities.
Compliance with Executive Order 1996-1
The Board provided an exposure draft of its proposal to stakeholders in early 2007. The Hospital and Healthsystem Association of Pennsylvania, the Pennsylvania Homecare Association and several individual nurses provided comments and suggestions to the Board that were incorporated into the proposed rulemaking. In addition, comments and suggestions were provided by the Independent Regulatory Review Commission (IRRC).
Fiscal Impact and Paperwork Requirements
The proposed amendments will not have an adverse fiscal impact on the Commonwealth or its political subdivisions as the Board is self-supporting. The proposed amendments will not impose any additional paperwork requirements upon the Commonwealth or its political subdivisions. To the extent that private sector providers of practical nursing education will be required to amend their curricula, there may be costs associated with the proposal. However, it is the Board's understanding, after meeting with educational program officials that the programs are willing to amend their curricula to meet the current demands of practice on LPNs. In addition, based on its meetings with representatives of HAP, the majority of hospitals and health care systems in this Commonwealth currently have IV therapy training programs for LPNs.
Sunset Date
The Board continuously monitors the cost-effectiveness of its regulations. Therefore, no sunset date has been assigned.
Regulatory Review
Under section 5(a) of the Regulatory Review Act (71 P. S. § 745.5(a)), on April 21, 2010, the Board submitted a copy of this proposed rulemaking and a copy of a Regulatory Analysis Form to IRRC and to the Senate Consumer Protection and Professional Licensure Committee and the House Professional Licensure Committee. A copy of this material is available to the public upon request.
Under section 5(g) of the Regulatory Review Act, IRRC may convey any comments, recommendations or objections to the proposed rulemaking within 30 days of the close of the public comment period. The comments, recommendations or objections shall specify the regulatory review criteria which have not been met. The Regulatory Review Act specifies detailed procedures for review, prior to final publication of the rulemaking, by the Board, the General Assembly and the Governor of comments, recommendations or objections raised.
Public Comment
Interested persons are invited to submit written comments, recommendations or objections regarding this proposed rulemaking to Ann Steffanic, Board Administrator, State Board of Nursing, P. O. Box 2649, Harrisburg, PA 17105-2649, within 30 days following publication of this proposed rulemaking in the Pennsylvania Bulletin.
ANN O'SULLIVAN,
ChairFiscal Note: 16A-5122. No fiscal impact; (8) recommends adoption.
Annex A
TITLE 49. PROFESSIONAL AND VOCATIONAL STANDARDS
PART I. DEPARTMENT OF STATE
Subpart A. PROFESSIONAL AND OCCUPATIONAL AFFAIRS
CHAPTER 21. STATE BOARD OF NURSING
Subchapter B. PRACTICAL NURSES
GENERAL PROVISIONS § 21.141. Definitions.
The following words and terms, when used in the subchapter, have the following meanings, unless the context clearly indicates otherwise:
* * * * * Bolus—A concentrated medication or solution given rapidly over a short period of time.
Central venous catheter—An intravenous (IV) catheter, the tip of which terminates in the superior vena cava and may be either tunneled, implanted, or percutaneously inserted.
* * * * * Focused assessment—Appraisal of an individual's current status and situation, which contributes to comprehensive assessment by the registered nurse and supports ongoing data collection.
* * * * * IV access device—A centrally or peripherally inserted catheter used for the purpose of intravenous infusion therapy, including peripheral short catheters, peripheral midline catheters, peripherally inserted central catheters and central catheters.
* * * * * PICC—Peripherally inserted central catheter—An IV catheter, the tip of which terminates in the superior vena cava and is confirmed by chest x-ray.
* * * * * Peripheral midline catheter—A peripherally inserted catheter, the tip of which terminates no further than the axilla and is between 3 inches and 8 inches (7.5 cm and 20 cm) in length.
Peripheral short catheter—A venous access device less than 3 inches (7.5 cm) in length.
* * * * * Titration of IV medications—A process by which medication is administered and dosages are adjusted through a continuous medication-containing intravenous infusion (such as vasoactive drugs, anticoagulants, psychotropic drugs, neuromuscular drugs, hormones, and the like) in order to effect a desired state based upon patient assessment data and prescribed parameters.
§ 21.145. Functions of the LPN.
(a) The LPN is prepared to function as a member of the health-care team by exercising sound nursing judgment based on preparation, knowledge, [skills, understandings and past experiences in nursing situations] experience in nursing and competency. The LPN participates in the planning, implementation and evaluation of nursing care using focused assessment in settings where nursing takes place.
(1) An LPN shall communicate with an RN and the patient's health care team members to seek guidance when:
(i) The patient's care needs exceed the licensed practical nursing scope of practice.
(ii) The patient's care needs surpass the LPN's knowledge, skill or ability.
(iii) The patient's condition deteriorates or there is a significant change in condition, the patient is not responding to therapy, the patient becomes unstable or the patient needs immediate assistance.
(2) An LPN shall obtain instruction and supervision if implementing new or unfamiliar nursing practices or procedures.
(3) An LPN shall follow the written, established policies and procedures of the facility that are consistent with the act.
* * * * * (f) [The LPN may perform venipuncture and administer and withdraw intravenous fluids only if the following conditions are met:
(1) The LPN has received and satisfactorily completed a Board approved educational program which requires study and supervised clinical practice intended to provide training necessary for the performance of venipuncture and the administration and withdrawal of intravenous fluids as author-ized by this section.
(2) A specific written order has been issued by a licensed physician for an individual patient under the care of a licensed physician.
(3) The LPN complies with written policies and procedures which are established by a committee of nurses, physicians, pharmacists and the administration of the agency or institution employing or having jurisdiction over the LPN and which set forth standards, requirements and guidelines for the performance of venipuncture by the LPN and for the administration and withdrawal of intravenous fluids by the LPN. A current copy of the policies and procedures shall be provided to the LPN at least once every 12 months. The policies and procedures shall include standards, requirements and guidelines which:
(i) List, identify and describe the intravenous fluids which may be administered by the LPN. The LPN is not authorized to administer the following intravenous fluids:
(A) Antineoplastic agents.
(B) Blood and blood products.
(C) Total parenteral nutrition.
(D) Titrated medications and intravenous push medications other than heparin flush.
(ii) List, identify and describe the circumstances under which venipuncture may be performed, including technical and clinical indications.
(iii) List, identify, describe and explain principles, including technical and clinical indications, necessary for the identification and treatment of possible adverse reactions.
(iv) Provide for and require inservice instruction and supervised practice to insure competent performance of venipuncture and competent administration and withdrawal of intravenous fluids.
(4) An accurate record is made concerning:
(i) The time of puncture or injection or withdrawal of the intravenous fluid.
(ii) The type of intravenous fluid injected.
(iii) The amount of intravenous fluid injected.
(iv) The site of the puncture of injection.
(v) Reactions to the puncture or the intravenous fluid injected.]
An LPN may perform only the IV therapy functions for which the LPN possesses the knowledge, skill and ability to perform in a safe manner, except as limited under § 21.145a (relating to prohibited acts), and only under supervision as required under paragraph (l).
(1) An LPN may initiate and maintain IV therapy only under the direction and supervision of a licensed professional nurse or health care provider authorized to issue orders for medical therapeutic or corrective measures (such as a CRNP, physician, physician assistant, podiatrist or dentist).
(2) Prior to the initiation of IV therapy, an LPN shall:
(i) Verify the order and identity of the patient.
(ii) Assess the patient for allergies, fluid and medication compatibilities.
(iii) Assess the patient's circulatory system and infusion site.
(iv) Assess all equipment.
(v) Instruct the patient regarding the risk and complication of therapy.
(3) Maintenance of IV therapy by an LPN must include ongoing observation and focused assessment of the patient, monitoring the IV site and maintaining the equipment.
(4) For a patient whose condition is determined by the LPN's supervisor to be stable and predictable, and rapid change is not anticipated, the supervisor may supervise the LPN's provision of IV therapy by physical presence or electronic communication. If supervision is provided by electronic communication, the LPN shall have access to assistance readily available.
(5) In the following cases, an LPN may provide IV therapy only when the LPN's supervisor is physically present in the immediate vicinity of the LPN and immediately available to intervene in the care of the patient:
(i) When a patient's condition is critical, fluctuating, unstable or unpredictable.
(ii) When a patient has developed signs and symptoms of an IV catheter-related infection, venous thrombosis or central line catheter occlusion.
(iii) When a patient is receiving hemodialysis.
(g) [The Board will issue annually to the LPN definitive information describing the nature, scope and extent of authorized functions and practice concerning immunization, skin testing, veni-puncture and the administration and withdrawal of intravenous fluids.]
An LPN who has met the education and training requirements of § 21.145b (relating to IV therapy curriculum requirements) may perform the following IV therapy functions, except as limited under § 21.145a and only under supervision as required under subsection (f):
(1) Adjustment of the flow rate on IV infusions.
(2) Observation and reporting of subjective and objective signs of adverse reactions to any IV administration and initiation of appropriate interventions.
(3) Administration of IV fluids and medications.
(4) Performance of site care.
(5) Performance of maintenance.
(6) Discontinuance of a medication or fluid infusion, including infusion devices.
(7) Conversion of a continuous infusion to an intermittent infusion.
(8) Insertion or removal of a peripheral short catheter.
(9) Maintenance, monitoring and discontinuance of blood, blood components and plasma volume expanders.
(10) Administration of solutions to maintain potency of an IV access device via direct push or bolus route.
(11) Maintenance and discontinuance of IV medications and fluids given via a patient-controlled administration system.
(12) Administration, maintenance and discontinuance of parenteral nutrition and fat emulsion solutions.
(13) Collection of blood specimens from an IV access device.
(Editor's Note: The following sections are new and the text has been printed in regular print to enhance readability.)
§ 21.145a. Prohibited acts.
An LPN may not perform the following IV therapy functions:
(1) Initiate administration of blood, blood components and plasma volume expanders.
(2) Administer tissue plasminogen activators, immunoglobulins, antineoplastic agents or investigational drugs.
(3) Access a central venous route access device used for hemodynamic monitoring.
(4) Administer medications or fluids via arterial lines.
(5) Administer medications via push or bolus route.
(6) Administer fibrinolytic or thrombolytic agents to declot any IV access device.
(7) Administer medications requiring titration.
(8) Insert or remove any IV access device, except a peripheral short catheter.
(9) Access or program an implanted IV infusion pump.
(10) Administer IV medications for the purpose of procedural sedation or anesthesia.
(11) Administer fluids or medications via an epidural, intrathecal, intraosseous or umbilical route, or via a ventricular reservoir.
(12) Administer medications or fluids via an arteriovenous fistula or graft, except for dialysis.
(13) Perform repair of a central venous route access device or PICC.
(14) Perform therapeutic phlebotomy.
(15) Direct access of implantable devices.
§ 21.145b. IV therapy curriculum requirements.
An IV therapy course provided as part of the LPN education curriculum as set forth in § 21.203 (relating to specific curriculum requirements for practical nursing programs) or as a stand-alone course offered by a licensed health care facility shall include instruction in the following topics:
(1) IV Infusion Therapy, as follows:
(i) Definition of IV therapy.
(ii) Indications:
(A) Fluid volume maintenance.
(B) Fluid volume replacement.
(C) Medication administration.
(D) Blood and blood product maintenance, monitoring and discontinuation.
(E) Nutritional support.
(iii) Types of vascular access delivery devices:
(A) Venous access devices.
(B) Central venous access devices.
(C) Peripherally inserted central venous access devices.
(iv) Age-related considerations and IV therapy (generally and within each major area as appropriate):
(A) Pediatric patients.
(B) Adult patients.
(C) Elderly patients.
(2) Legal implications for IV nursing practice:
(i) Pennsylvania Code—Title 49, Chapter 21, Subchap- ter B. Practical Nurses.
(ii) Institutional policy and procedure.
(iii) Standards of practice.
(iv) Accountability in infusion therapy.
(v) Malpractice liability.
(vi) Documentation.
(vii) Quality assurance.
(viii) Continuing education.
(ix) Patient rights.
(3) Related anatomy and physiology (including age-related differences).
(4) Fundamentals of fluid balance and electrolyte balance (including age-related differences).
(5) Equipment and supplies used in the preparation and administration of IV therapy:
(i) Administration sets:
(A) Primary.
(B) Secondary or piggyback, saline lock, Y type administration with controlled volume, filters.
(ii) Needleless systems.
(iii) Venous access devices.
(iv) Infusion site preparation and site dressing materials.
(v) Infusion regulation systems (pumps and controllers).
(vi) Labels.
(vii) Hanging devices.
(6) Parenteral solutions and indications for use (isotonic, hypotonic, hypertonic).
(7) Infection control and safety issues:
(i) Transmission.
(ii) Types of infections:
(A) Local.
(B) Systemic.
(iii) Prevention measures.
(iv) Standard precautions.
(8) Insertion of peripheral short catheters (theory and lab):
(i) Equipment.
(ii) Site selection.
(iii) Site preparation.
(iv) Inserting the IV access device.
(v) Dressing the site.
(vi) Documentation.
(9) Administration, maintenance and monitoring of peripheral IV therapy (theory and lab):
(i) Focused assessment pertaining to IV therapy.
(ii) Calculating IV rate.
(iii) Terminology.
(iv) Drug compatibility.
(v) Drug information.
(vi) Methods/technique of administering IV medica- tions/fluids.
(vii) Continuous and intermittent monitoring of IV medications/fluids.
(viii) Local complications and nursing interventions:
(A) Phlebitis/thrombosis.
(B) Infiltration/extravasation.
(C) Catheter displacement.
(D) Occlusion.
(E) Hematoma.
(F) Cellulitis.
(G) Local infection.
(ix) Systemic complications:
(A) Sepsis.
(B) Medication and fluid interactions.
(C) Allergic reactions.
(D) Embolism.
(x) Documentation.
(xi) Discontinuing a peripheral IV.
(10) Centrally and peripherally placed vascular access devices:
(i) Indications for centrally placed devices.
(ii) Disadvantages and advantages.
(iii) Placement of devices:
(A) Review anatomy.
(B) Usual sites.
(C) Types of devices:
(I) Tunneled.
(II) Nontunneled.
(III) Implanted ports.
(IV) PICC.
(iv) Insertion-related complications:
(A) Pneumothorax.
(B) Air embolism.
(C) Catheter malposition.
(D) Mediastinal injury.
(E) Hemothorax.
(F) Chylothorax.
(G) Hydrothorax.
(H) Brachial plexus injury.
(I) Arterial laceration.
(J) Extravascular malposition.
(K) Intravascular malposition.
(L) Pericardial tamponade.
(v) Long-term complications:
(A) Dislodgement.
(B) Air embolism.
(C) Local infection.
(D) Sepsis.
(E) Catheter migration.
(F) Catheter occlusion.
(G) Vessel thrombosis.
(H) Damaged catheter.
(I) Superior Vena Cava Syndrome.
(J) Skin erosion.
(vi) Maintaining central venous infusions (differentiate for types of access devices):
(A) Checking placement.
(B) Changing dressings.
(C) Changing IV tubing and solution.
(D) Changing catheter cap.
(E) Flushing.
(F) Administering primary or secondary infusion.
(G) Obtaining a blood sample.
(H) Determining intake and output.
(I) Documenting.
(11) Special considerations:
(i) Setting:
(A) Acute care.
(B) Home care.
(C) Long-term care.
(D) Ambulatory care.
(E) Hospice care.
(ii) Patient education.
(iii) Ethical/cultural issues.
(iv) Other—geographical practice setting differences.
[Pa.B. Doc. No. 10-773. Filed for public inspection April 30, 2010, 9:00 a.m.]
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