NICA MINIMUM STANDARDS FOR IN-OFFICE INFUSION
NICA MINIMUMSTANDARDSFOR IN-OFFICEINFUSIONA threshold for minimum standards ininfusion practice and quality of care.
TABLE OF CONTENTSTeam01Disclaimer02Introduction03Glossary of Terms04NICA Minimum Standards07
NICA would like to extend our warmest gratitude to the Board members,Advisory Committee members, and editors who graciously donated their timeand expertise to develop the NICA Minimum Standards for In-Office Infusion.NICA BOARD MEMBERSNICA ADVISORY COMMITTEEEDITORSAmy Arredondo, RNGary Cooper, MHAShannon Fisher, RN, MHAC. Bryan JohnsonMark ElliottMelinda J Martin-Lester, BA, RN,Kaitey Morgan, RN, CRNIDavid GoodallCHCR. Reece Norris, JDKen Idicula, MHAMatt Munden, RN, BSNCharlie SchadewaldChristine Mann, MBABrian Nyquist, MPHGreg Mitchell, JDTanya VanHoose, BS, RNBrit Pim, MBAJulie Williams, MBA, BS, RNJosh SmithKatie Thackston, JD, MBAAll rights reserved by National Infusion Center Association. No part of this document’s content may be reproduced, recreated, or published in any form by any means,except with the prior written permission of NICA.1
DISCLAIMERThe National Infusion Center Associationas new information becomes available oror statute to determine if a higher level(NICA) is pleased to present the 1stin response to changes in the regulatoryof rigor is required. Consult with youredition of the NICA Minimum Standardsenvironment. As such, the minimummedical malpractice coverage andfor In-Office Infusion for use in facilitiesstandards presented in this documentprovider to ensure compliance with yourthat are preparing and administeringare current as of the date of publicationpolicy.parenteral therapies.and are subject to change. Changesto these minimum standards will beNICA assumes no responsibility forThe standards outlined in this documentreflected periodically in an updatedthe recommendations or practiceswere established per industry guidanceversion.of any healthcare provider or for thepolicies, procedures, and practices ofand documented best practicesamong facilities represented on NICA’sThe information contained in thisany facility. NICA assumes no liability forAdvisory Committee. These standardsdocument is intended for reference.any injury and/or damage to persons orare intended to establish a minimumThese standards are intended toproperty arising from or related to thethreshold for various operational andsupport—not supersede—medicaluse of or reliance of the NICA Minimumclinical aspects associated with themalpractice insurance coverage, stateStandards. NICA assumes no liabilitypreparation and administration ofregulation, rules, or statute including,for any loss, damage, or expense fromparenteral medications in an effort tobut not limited to: Nursing Practiceerrors or omissions in the NICA Minimumsupport safe, consistent, high-qualityActs, Board of Nursing rules, regulatoryStandards, whether arising in contract,care across access points. The practiceoversight determinations. Defer to yourtort, or otherwise.of infusion/injection therapy may changestate’s regulation, rules, requirements,2
INTRODUCTIONTHESE MINIMUM STANDARDSARE INTENDED TO:To promote patient safety, consistent Reduce disparities in quality of care acrossoutpatient care settings;quality of care, and establish foundationalstandards of practice, the National Infusion Ensure that the public is protected fromCenter Association (NICA), in collaborationunscrupulous, incompetent and unethicalwith its Board of Directors and Advisorypractitioners; and,Committee comprised of thought-leaders Offer some assurance to the public thatand subject matter experts, developedthe individuals preparing and administeringa set of minimum standards of practiceparenteral medications have been educatedin the procedures and demonstratedfor the preparation and administrationcompetency in providing infusion/injectionof non-hazardous provider-administeredintravenous and injectable products in anWith the expansion of the outpatientoutpatient setting.infusion/injection market, and an explosionin the number of “med-spas” and “hydrationThis document is the result of aclinics”, it is no longer reasonable to expectcollaborative effort in 2018 and 2019 byconsistent quality of care across therepresentatives from nine organizationsnational infusion delivery channel. NICAheavily engaged in outpatient infusion/believes that a standardization in practiceinjection. It has been developed to assistand quality of care, at least by establishingfacilities engaging in the preparation andminimum thresholds, is necessary toadministration of provider-administeredsupport continued patient safety andintravenous/injectable medicationsresponsible expansion of the deliveryin providing patients with access tochannel.safe, consistent, high-quality infusionpreparations and an optimal infusion/injection experience in a safe environment.services in a safe, consistent, and effectivemanner.The following list outlines these industryaccepted minimum standards relating tothe preparation and administration of nonhazardous infusion/injectable medications,including biologics and specialtymedications in an outpatient setting.These minimum standards apply to alloutpatient facilities in which venousaccess is established and consumers arereceiving solutions through intravenous(IV) infusion, subcutaneous (SC) infusion, IVpush, or injection.3
GLOSSARY OFTERMSActive IngredientAn active ingredient is any component thatprovides pharmacological activity or otherdirect effect in the diagnosis, cure, mitigation,treatment, or prevention of disease, or to affectthe structure or function of the body. (The U.S.Food and Drug Administration)Beyond-Use Date (BUD)For the purposes of this document, BeyondUse-Date refers to the time by which a multiuse vial of medication, once accessed, ormedication preparation, once mixed, must beused before it is at risk of chemical degradation,destabilization, contamination, and/orpermeability of the medication container (seeallergenics, somatic cells, gene therapy, tissues,and recombinant therapeutic proteins. (See“Therapeutic Biological Products”) (The U.S. Foodand Drug Administration)Biological products can be composed of sugars,proteins, or nucleic acids or complex combinationsof these substances, or may be living entitiessuch as cells and tissues. Biological products areisolated from a variety of natural sources—human,animal, or microorganism—and may be producedby biotechnology methods and other cuttingedge technologies. Gene-based and cellularbiologics, for example, often are at the forefrontof biomedical research, and may be used to treata variety of medical conditions for which no othertreatments are available.As used in Section 503A (21 USC 353a(f)),compounding does not include mixing,reconstituting, or other such acts that areperformed in accordance with directions containedin approved labeling provided by the product’smanufacturer and other manufacturer directionsconsistent with that labeling. (The U.S. Food andDrug Administration)DosageIn the context of this document, dosage refersto the amount of a medicine or drug that shouldbe administered to a patient per the drug order.(See “Drug Order”)DrugClinicianDefined as a substance: (1) recognized by anDefined as a person qualified in the clinicalofficial pharmacopeia or formulary; (2) intendedpractice of medicine, psychiatry, or psychologyfor use in the diagnosis, cure, mitigation,as distinguished from one specializing intreatment, or prevention of disease; (3) (otherlaboratory or research techniques or in theory.than food) intended to affect the structure or(Merriam-Webster)any function of the body; (4) intended for use asa component of a medicine but not a device or a“Medication Container”). The BUD is determinedby the individual that first accessed the multi-Compoundingcomponent, part or accessory of a device. (Theuse vial, or prepared the medication, basedDefined as the process of combining, mixing,U.S. Food and Drug Administration)on the date and/or time the medication vial isor altering ingredients of a drug to create aaccessed or the medication is prepared.medication tailored to the needs of an individualpatient. Compounding includes the combiningBiological ProductInclude a wide range of products such asvaccines, blood and blood components,of two or more drugs. Compounded drugs arenot FDA approved. (The U.S. Food and DrugAdministration)In general, the term “drugs” includes therapeuticbiological products, or “biologics” (see“Therapeutic Biological Products”). Biologicalproducts are included within this definition andare generally covered by the same laws andregulations, but differences exist regarding theirmanufacturing processes (chemical processversus biological process).4
Drug Orderdecisions) about the risks, benefits, andLyophilization (or freeze drying)Refers to an order, written or transmitted byalternatives of a given procedure or interventionDefined as a process in which water is removedother means of communication, for an ultimateand receives authorization or agreement tofrom a product after it is frozen and placed underuser of any drug or device issued and signedundergo a specific medical intervention. Thevacuum, allowing the ice to change directlyby a Licensed Independent Practitioner. (Seepatient must be competent to make a voluntaryfrom a solid to vapor without passing through a“Licensed Independent Practitioner”)decision about whether to undergo the saidliquid phase. Products are manufactured in theprocedure. (The American Medical Association)lyophilized form due to their instability when insolution. (The U.S. Food & Drug Administration)Expiration DateRefers to the time period during which theLabelproduct is known to remain stable and retainThe FDA approved label is the official descriptionMedicationits strength, quality, and purity when storedof a drug product which includes indication (whatDefined as a substance used in treating diseaseaccording to the storage conditions outlinedthe drug is used for); who should take it; adverseor relieving pain. (Merriam-Webster)in the product’s label. (see “Label”) Theevents (side effects); instructions for uses inexpiration date is determined by the product’spregnancy, children, and other populations; andMedication Dosagemanufacturer. (The U.S. Food and Drugsafety information for the patient. Labels areRefers to the determination and regulation ofAdministration)often found inside the drug product packaging.the size, frequency, and number of doses of a(The U.S. Food and Drug Administration)medication.Licenses Independent Practitioner(LIP)Medication ContainerDefined as an individual, as permitted by lawmedication preparation (e.g., IV bag, vial, ampule).The FDA regulations require drug applicants toprovide stability testing data with a proposedexpiration date and storage conditions uponsubmission of an application for FDA approval.Facilityand regulation, and also by the organization, toRefers to a site of care in which an order forprovide care and services without direction ormedical treatments and services are provided.supervision within the scope of the individual’slicense and consistent with the privilegesInformed ConsentRefers to a process in which a health careprovider educates a patient (or the patient’sgranted by the organization. Each state hasdifferent laws defining who can practice withoutsupervision. (The Joint Commission)Refers to a vessel that contains a medication orParenteral MedicationsRefers to medications that are not deliveredvia the intestinal tract (i.e., any non-oral meansof administration), but is generally interpretedas relating to injecting a medication directlyinto the body, bypassing the skin and mucoussurrogate if the patient lacks decision-makingmembranes. The common parenteral routescapacity or declines to participate in makingof medication administration are intravenous5
(IV), subcutaneous (SC), or intramuscular (IM).Therapeutic Biological Product(Nursing Times)Defined as a protein derived from living materials(e.g., cells or tissues) used to treat or cure aPreparationdisease. Commonly referred to as a “biologic”.In the context of this document, preparation(The U.S. Food and Drug Administration)refers to the act of diluting, mixing,reconstituting, or otherwise preparing a singlemedication (active ingredient) in accordancewith the manufacturers’ instructions or productlabeling for administration to a single patientbased on a specific order.Rate of AdministrationRefers to the rate at which a drug should beadministered to achieve a medication dose overa period of time which has been demonstratedto be safe and therapeutically effective.Commonly expressed as volume or dosage to beadministered per minute or per hour. Also knownas “dosage rate”.Reaction Management KitRefers to an organized collection of medications,supplies, and equipment, necessary to addressand manage a hypersensitivity reaction.Route of AdministrationRefers to the way in which a drug is administeredto a patient. (e.g., oral, topical, parenteral (“SeeParenteral Medications”).6
NICA MINIMUM STANDARDS FOROUTPATIENT INFUSIONThe facility/employer must have a written institutionalpolicy and/or procedure for at least the following: The preparation and administration of intravenous/injectableassessment must be documented in the employee’s personnel fileand updated at least annually. Developing and maintaining an up-to-date protocol for everymedication administered in the facility, including at least:medications describing at a minimum:storage, handling, preparation, stability, administration,1.the role of personnel involved in each activity and personalmonitoring requirements (if applicable), and reportingprotective equipment to be used;2.the delegation of these activities;3.the monitoring/supervision of delegated activities;4.performing medication preparation on open benchtop;5.performing medication preparations that may fall under Board ofrequirements (if applicable). A policy for patient education. Such policy must include at aminimum: labelPharmacy jurisdiction (See Minimum Standard No. 11); and,6. patient assessment.Assessing and documenting education and clinical competencyamong personnel performing preparation and administration Any product-specific requirements (e.g., drug safety program)The observation of patients receiving treatment. Such policymust include the periodic observation of patients receivingactivities. Educational requirements outlined in the manufacturer producttreatment and during a post-administration observation period(if applicable).Personnel involved in the preparation or administration ofintravenous or injectable medications, including biological products,must be assessed on whether the individual has received adequate Clinician-to-patient ratio. Ratios may vary, but should dependeducation on performing the procedure(s) and demonstratedon clinician experience, availability and capability support staff,clinical competence in performing the procedure(s).route of administration, drug mix, patient history and acuity.To safeguard patients against risks or complications, such Medication storage, handling, and disposal.7
Labeling of prepared medications. Observation of patients receiving infusions. Including whatconstitutes an “observation” touchpoint and frequency ofobservation.Frequency may vary based on clinician experience, risk of reaction,*patient history and acuity. The use and maintenance of the reaction management kit,including at least: (1) the use of medications and productscontained in the kit; (2) a procedure for checking the kit at leastmonthly; and, (3) process for documenting the replacement ofany expired drugs or items. Addressing, documenting, and reporting adverse events. Safe injection practices, infection control, and mitigating risk ofexposure to bloodborne pathogens. Responding to, documenting, and reporting needle-stick injuriesin the workplace. Documenting medication administration, which must complywith the principles of documentation. Such documentation mustA patient-specific drug order must be available from aLicensed Independent Practitioner (LIP) (e.g., physician,nurse practitioner) that details the following, at aminimum: Medication Medication dosage Route of administration Rate of administration Frequency and duration of administration Treatment monitoring requirements (as applicable) Pre-medication (if indicated) Orders for management of an acute infusion/injection reactionInformed consent must be obtained and documentedin the medical record prior to the delivery of care. It isimportant to recognize that obtaining informed consentis an educational process involving the patient in shareddecision-making.include, at a minimum: safety precautions utilized, vitals (collected at the following timeIn obtaining informed consent, the health care providershould:points, at a minimum: baseline and post-treatment or prior to Medication, dosage, route of administration, rate of administration,discharge, if indicated)Assess the patient’s ability to understand relevant medicalinformation and the implications of treatment alternatives andto make an independent, voluntary decision.8
Present relevant information accurately and sensitively, in Inform patient of the prescribed medication, route ofkeeping with the patient’s preferences for receiving medicaladministration, approximate time of treatment, pre-medicationsinformation. Information should include:(if indicated), and provide the opportunity to ask questions; The diagnosis (when known) Collection of vitals (See Minimum Standard no. 6); The nature and purpose of recommended interventions Review medical history for previous 24 hours (including new The burdens, risks, and expected benefits of all options,medical diagnoses, recent hospitalizations, current medicationstaken, medication allergies, recent surgeries);including forgoing treatment.Document the informed consent conversation, or written fever, abnormal lab values)consent, and the patient’s (or surrogate’s) decision in themedical record in some manner.* An assessment of education needs regarding diagnosis,prescribed treatment, route of administration, approximateUpdating informed consent at least annually is recommended.The facility/employer must have a Licensed IndependentPractitioner readily available, at least by phone, duringmedication administration.Assess for contraindications specific to ordered treatment (e.g.,duration of treatment, pre-medications (if indicated), etc. Obtain measured patient weight at initial appointment andreassessed at established intervals per facility policy. Forpatients receiving medications with weight-based dosing,weight must be measured and recorded at each treatment.An assessment of the patient must be performed,in accordance with state nursing practice acts, anddocumented prior to each treatment. Such assessmentmust include, at a minimum, the following: It is recommended that during patient assessmentsstaff also: currently taking antibiotics;Confirm patient name, date of birth, diagnosis, medicationto be administered, medication dose appropriate for patient/Confirm patient does not have an active infection and/or is Provide written information (e.g., FDA-approved patientweight, administration protocol (infusion rate, requirementsmedication guide) for review prior to initial treatment, and befor filtration, monitoring requirements), pre-administrationmade available at each subsequent treatment, ensuring that allrequirements (e.g., laboratory monitoring);questions are answered.9
At a minimum, the following data must be collectedand documented for every patient before treatmentand after treatment (for IV and injectables without anobservation period) or prior to discharge (for injectableswith an observation period):* Temperature Blood pressure clinical competency in the delegated activity.The facility/employer must provide education and skilltraining relati
solution. (The U.S. Food & Drug Administration) Medication Defined as a substance used in treating disease or relieving pain. (Merriam-Webster) Medication Dosage Refers to the determination and regulation of the size, frequency, and number of doses of a medication. Medication Container Refers to a vessel that contains a medication or
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