Legal Issues: PICC Line And Midline Program

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SAMPLE POLICY & PROCEDURELegal Issues: PICC Line and Midline ProgramOutline: regulations regarding PICC Line or Midline placementNursing qualifications to place a PICC Line or MidlineNursing competencyPolicies and Procedures for PICC Lines and MidlinesPatient consent for PICC Line or Midline placementState Regulations regarding PICC Line or Midline placement:As of 1994, all fifty states either specifically include PICC Line placements within thescope of nurse’s practice, or make no statement either way. Every state currently has atleast one or more nursing based PICC Line insertion programs. While it is legal fornurses to insert PICC Lines throughout the United State, each state does differ onrestrictions and provisions it imposes on placements. For example: some states allow noPICC Line placement in the home and some states require x-ray verification of PICCLine tip position. It is important to know what your states policy is regarding PICC Lineplacement. The attached table (taken from the 1999 “Bard Access Systems PICC /Midline Training Manual” & the INS Course “Peripherally Inserted Central Catheter(PICC) Midclavicular and Midline Catheters” published in 1999) looks at the position ofeach State Nursing Board with regard to suturing, lidocaine usage, home placements etc.In addition, a table of State Board of Nursing addresses is available for those individualswanting updated information. With technological changes nurses are investigating theuse of modified Seldinger technique. As you will see from the tables most states do notrestrict the utilization of this technique for those states that do it is best to contact themdirectly for an opinion. When addressing a state it is important to identify other stateswhere modified Seldinger technique is utilized successfully by nursing and theimproved patient outcomes that may result from using this technique. It is also importantto confirm in writing that the modified Seldinger technique does not utilize thephysician approach of threading a catheter over a guide-wire. But rather it uses a shortstylet (15 cm.) wire to ascertain vein patency ad then utilizes a dilator over the wire (60cm) to actually thread the PICC Line. The technique for Seldinger versus modifiedSeldinger vary greatly.Note: There is no State Board of nursing restrictions on the issue of Registered Nursingplacement of Midline catheters.DRAFT10/16/06

SAMPLE POLICY & PROCEDURENursing qualifications to place a PICC Line or Midline:INS (Intravenous Nursing Society (617) 441-3008) is the only organization to referencequalifications for a nurse placing a PICC Line or Midline catheter. This information hasbeen referenced from the Intravenous Nurses Society Position Paper entitled“Peripherally Inserted Central Catheters (PICCs) and the Intravenous Nursing SocietyCourse entitled “Peripherally Inserted Central Catheter (PICC) Midclavicular andMidline Catheters Assessment and Planning, Care and Maintenance, Complications”Recommended criteria & components of an institutions PICC Line and Midlineprogram1. Choose a clinician that is a licensed physician or licensed registered nurse asdetermined by state regulations2. Choose a clinician that is educated with demonstrated competency andproficiency in intravenous therapy Including the insertion of short peripheral catheters Solid understanding of central venous catheters3. Provide the registered nurse with an educational program for PICC insertion The educational program must include theoretical content and clinicalinstruction on an anatomical model4. Ascertain that the nurse has validated initial competency. There must be anongoing continuum of competency Establish a program for maintaining clinical competency for deviceinsertion Which includes the knowledge and ability to perform the insertionsafely Which includes knowledge of care and maintenance strategies5. Program and clinician qualifications must be consistent with state and federallaws6. Documentation of insertions and outcomes analysis must be performed. Eachorganization must set up its own requirements for initial qualifications and requalification.Recommended Education for Clinicians inserting PICC Lines andMidline Catheters1. Documented 1600 hours of clinical practice with I.V. therapy responsibilitiesduring the previous two years2. Documented experience in central venous device management3. Completion of a course in PICC and extended duration peripherally insertedcatheter instruction: The cognitive portion of this program must be completed through(a) Classroom attendance(b) Self-study modules(c) Interactive training techniques(d) Combination of 1,2, and 3DRAFT10/16/06

SAMPLE POLICY & PROCEDURERecommended education for the clinician caring for PICC Line andMidline catheters:1. The nurse should be knowledgeable in the following areas: All routine nursing care tasks including: dressing change, tubing/injectioncap change, flushing, and blood withdrawal procedures All possible complications associated with the chosen device and therecommended methods to manage those complications Performance improvement and documentation of outcomes The design, indications, contraindications, precautions, for the specificdevice being used as written in the manufacturer’s literature The methods of infusion through the device including: Possible flow rates Pressure ratings of catheter Infusion pressure from the chosen flow control device Considerations for manual injections with syringes Additional resource people to contact for assistance Nurse who inserted the device Clinical support from manufacturerRecommended qualifications for clinicians teaching PICC Line orMidline Catheter insertion:1. Must meet all of the recommendations for clinicians inserting these devices2. Documented (5) successful catheter insertions in order to mentor or observethe insertions of another clinical – Precepting Criteria3. And (25) insertions in order to teach PICC Line or Midline catheter insertion– Teaching Criteria4. The instructor should have documented understanding of the principles ofadult learning and employ these principles in: Assessing the learner’s needs Program development processes Appropriate teaching and learning strategies Evaluation processesDRAFT10/16/06

SAMPLE POLICY & PROCEDURENursing competency:INS (Intravenous Nursing Society) recommends that an institution create a set criteria toevaluate the competency of nurses learning to place PICC Line / Midline catheters. Thisprocess should be ongoing such as a yearly competency of nurses placing PICC Line orMidline catheters.However, it should be noted that nurses can not be certified in PICC Line or Midlinecatheter placement or care and maintenance. The formal definition for certificationinvolves taking a test from an organization or state with a certification board. However,nurses may be qualified (deemed competent) for PICC Line or Midline Catheterplacement or care and maintenance, in your particular institution. It has been suggestedby some State Boards of Nursing that nurses observe (1) – (3) successful insertions andperforms under supervision (3) – (5) successful insertions. Some State Boards of Nursingrequire that the employer keep this documentation on file.For your convenience a template has been developed for clinician competency in theform of a checklist. Please fill free to utilize this template in creating your owninstitution competency evaluation form.Qualification Requirements forPICC Line & Midline Catheter InsertionQualifying training, experience and evaluation: Successfully complete theoretical course with Didactic (with supervisedpracticum) Successful insertion PICC Line and / or Midline catheter on Peter PICC orpractice arm Observe successful insertions by a qualified clinician placing PICCLines or Midline catheters Be observed placing successful insertions by a qualified preceptorplacing PICC Lines and / or Midline catheters (see qualification skillschecklist)Annual re-qualifying experience and evaluation: Minimum insertion of catheters per year must be completed to maintaincompetency. The employee performed PICC Line insertionyear and Midline insertions yearDRAFT10/16/06

SAMPLE POLICY & PROCEDURE Annual evaluation by qualified preceptor placing PICC Lines and / or Midlinecatheters. The clinician is observed successfully placing PICC Linesand or Midline catheters a year in accordance with the qualification skillcompetency checklist. Review of quality management data of PICC Line and Midline cathetersplaced during the past year Review of current manufacturer information, literature, guidelines, standardson PICC Line and Midline catheter insertion, care and maintenance,complication management and outcomesCopy of recorded training competency to be kept in employees personnel fileQualification Skills Checklist forPICC Line and / or Midline InsertionClinician Name/Title:ActivityPerformed Observation Precept AnnualDate ActivityEmployee Identification No.PreceptorNamePreceptor TitleCompetencyPatient MR #CompetencyYesDRAFT10/16/06No

SAMPLE POLICY & PROCEDURECompetency Skills Checklist:Competency SkillPICC Line / Midline Catheter PlacementPrior to PICC Line or Midline Catheter insertion thecompetent clinician will:Review patient chart for: Physician order (for Midline catheterinsertion the physician order is for fluids ora standard peripheral catheter) Patient allergies Patient coagulation status Patient contradictions to vascular accessplacement Patient labs and medial historyExplain: Procedure to patient Catheter management to patient Obtain signed consent form (PICC Lineonly)Identify, Evaluate and Select: Appropriate vein Appropriate insertion site Location of artery Choose appropriate catheter length andgauge size Position patient properly Correctly measures patient properly forcatheter tip location (optional) measures arm widthSet-Up Gathers appropriate equipment Wash Hands Set up equipment and sterile field withsterile technique / Utilize universalprecautions / Utilize full barrier precautions Preflushed catheter / syringes / extensionsets etc. (trimming optional)During PICC Line and Midline Insertion:A. Perform appropriate Skin Prep (place tourniquet /change gloves) Sterile draping of insertion arm and siteDRAFT10/16/06SatisfactoryNotSatisfactory

SAMPLE POLICY & PROCEDURECompetency SkillPICC Line / Midline Catheter PlacementDuring PICC Line and Midline Insertion:Perform Appropriate: Venipuncture / observe flashback Modified Seldinger (optional) Use of wire Use of Scalpel Use of dilator Advance Catheter (check patientpositioning of head) Remove introducer (dilator) Remove guidewire Attach hub (Groshong ) Ascertain blood return Suture or utilize securing method Apply dressingUpon Completion of insertion:Document in patient medical record: Allergies Site limitations Blood coagulation problems Patient complications that occurred duringinsertion Contraindications to usage of line placed Patient teaching / Patient consent Anesthetic used Catheter gauge size (french), number oflumens, length, suspected tip position(awaiting x-ray), vein and insertion site Describe general sterile insertion andproblems encountered Arm circumference (optional) Catheter lot number and brand Catheter method of securement anddressing Blood return and flushing Contact Radiology for chest x-rayProvide the patient Patient care handbook and care instructionProvide the nursing staff Patient status report Instructions: flush protocol, hot packs,dressing changesDRAFT10/16/06SatisfactoryNotSatisfactory

SAMPLE POLICY & PROCEDURECompetency SkillPICC Line / Midline Catheter PlacementSatisfactoryNotSatisfactoryUpon Completion of insertion:Contact RadiologyConfirm catheter tip position and reposition / re-dress if needed or send toInterventional Radiology for re-positioningif available Ascertain nursing staff has been contactedand physician regarding catheter tipposition and usage Document approval from Radiology orAttending Physician to use catheter forinfusionFor Discontinuation of catheter:A. Review order for catheter removalB. Assess need for catheter tip culture and orblood cultures (perform if needed)C. Removal process Wash hands / Utilize universal precautions Assess patient and site Speed of removal (slow) Observe howclinician handles complications If unable to remove apply heat and wait If unable to remove contact physicianfor possible x-ray or venogram need Confirm catheter measurement D. Documentation post removal Patient complications during removal Measurement of catheter length comparedto insertion length Patient tolerance Cultures or labs sent for analysisE. Report to Staff Nurse Any complications during removal ofcatheter / How to handle complications Patient toleranceAttach list of articles / manufacturer literature / continuing educationrelated to re-qualification of competency for PICC Line and / orMidline catheter insertion.DRAFT10/16/06

SAMPLE POLICY & PROCEDURESummary:If we review State Board of Nursing recommendations and INS (Intravenous NursingSociety Standards & Position Statement the following conclusions regarding PICC Linequalifications for a Registered Nurse can be drawn. Midlines have few recommendationsfrom State Board of Nursing Agencies except to say that they do not have to be x-rayed.There is no documentation that Midlines need a separate physician order besides theoriginally written physician order. PICC Lines however, have consistentrecommendations as follows from state to state:1. The RN who wishes to place and remove PICC Lines should attend aneducational course that lasts approximately 6 – 8 hours in duration2. This course must include: anatomy, physiology, care and maintenance,pharmacology, patient education, patient selection, emergency and nonemergency complication management, sterile insertion technique, qualityassurance management and data collection3. This course must have a theoretical component and a hands on practicum withsupervision4. The employer must have policies and procedures available on insertion andcomplication management5. The RN who places PICC Lines must prove that they have attended a courseand the employer should have proof of attendance on file6. The RN who places PICC Lines needs to prove competency in the techniqueof PICC Lines placement. Some states have defined this competency as (1 –3) observed insertions and (3-5) successful insertions observed by a proficientRN. This documentation should be on file with the employer.7. The RN who places PICC Lines needs to prove competency yearly8. The RN who is learning to place PICC Lines should be precepted by acompetent, qualified, and knowledgeable RN9. Radiographic confirmation of catheter tip position is optimal10. The LVN or LPN role in PICC Line placement is limited11. PICC Lines should have a written physician order12. Continuing education is a requirement for nurses placing PICC LinesDRAFT10/16/06

SAMPLE POLICY & PROCEDUREPatient Consent(Information taken from “Nurses and The Law A Guide to Principles andApplications” by Nancy J. Brent published in 1997 by W.B. Saunders)Informed Consent:A patient’s right of informed consent includes knowing and understandingwhat health care treatment is being undertaken. Obtaining informed consentis also important to the health care provider for without it; he or she may besubject to lawsuit alleging assault, battery, negligence, or a combination ofthese causes action.Types of Consents:1. Expressed Consent: Oral declaration concerning a particular treatment (“Yes”) Written document (a consent form) that the patient signs. The written consent isused often for PICC Line placement. A written consent is not required but provides evidence to prove that consent wasobtained if a suit is filed alleging that consent was not obtained prior to treatment.2. Implied Consent: Is consent that is giving by an individuals conduct rather than a verbal or writtenconsent. Such as a patient sticking their arm out for a blood pressure impliesconsentElements of Consent:1. Patient must have decision-making capability (A parent, guardian, or family membermay have to provide consent)2. Consent must be in patient’s native language at their educational level3. Consent must be given voluntarily and freely without duress or coercion4. Consent must not be obtained under fraudulent circumstances5. The patient must have knowledge and understanding of the proposed medicalregimen. (Ask the patient if they have any questions regarding their procedure andprovide written instruction regarding their procedure)DRAFT10/16/06

SAMPLE POLICY & PROCEDUREWho Should Obtain the Consent?1. Physician who is doing the procedure2. Clinician (Nurse) who is doing the procedure3. Key: Who is performing the procedure and documenting the consent in the patentmedical records and could testify as to what was said to the patientInformation to be Provided During Consent: diagnosisType of treatment or procedure or medicationExplanation of procedure or treatment or medication and its intended purposeHoped for benefits from the proposed treatment, procedure or medication (with noguarantees to outcomes!)5. Material risks, if any of the treatment, procedure or medication6. Alternative treatments, if any7. Prognosis if the recommended care, procedure, treatment, or medication are refusedDocumentation of Informed Consent:1. Blanket consent forms are the type of consents signed on patient admittance which isnot treatment specific. It arguably gives a health care provider unbridled authorityand discretion to provide whatever treatment is decided upon by the provider. Theseare not recommended for treatment specific procedures. It is up to your institutionto determine if PICC Line and Midline insertion require a treatment specificconsent.2. Battery Consents protect health care providers against allegations of battery andinclude information specific to a particular procedure or treatment. They are differentfrom treatment specific consent forms, which are detailed.3. Treatment Specific Consents are written and are very detailed in description of theprocedure, complications and alternatives. These are often used for the placement ofcentral lines (PICC Lines).The use of a written consent form to document permission for treatment cannot avoid alllegal problems. The patient can challenge the way in which the consent was obtained,what information was shared concerning the recommended treatment, or other aspects ofthe process of obtaining informed consent. Challenges can also be raised about the formitself. It is best to contact Risk Management in your hospital to evaluate the need for awritten consent for PICC Line and / or Midline catheter placement. No matter how theconsent is obtained verbally or written documentation in the patient’s medical record iscrucial. For your information a sample consent is attached.DRAFT10/16/06

SAMPLE POLICY & PROCEDUREPICC LINE INSERTION INFORMED NURSINGCONSENTAND AGREEMENT FOR TREATMENTI agree to have a Peripherally Inserted Central Catheter (PICC) placed in myarm.The catheter insertion procedure, care, maintenance and, complications havebeen explained to me and I understand them.I understand that this is not the only way I can receive my medication. Iunderstand that my health care team has determined that the PICC line would bethe safest and most effective means of giving my medication at this time.Alternative vascular access device optionsof giving mymedication have been explained to me and I have chosen this one.I realize this procedure will be performed only by a nurse who has been speciallytrained and certified to insert PICC lines.My catheter will be inserted by .I realize that this is an invasive procedure and has certain risks such as c

SAMPLE POLICY & PROCEDURE DRAFT 10/16/06 Legal Issues: PICC Line and Midline Program Outline: 1. State regulations regarding PICC Line or Midline placement 2. Nursing qualifications to place a PICC Line or Midline 3. Nursing competency 4. Policies and Procedures for PICC Lines and Midlines 5. Patient consent for PICC Line or Midline placement

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