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(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 relating to the preparation and administrationof parenteral medications for all personnel involved inthese procedures. Such education and skill training mustinclude at a minimum:1.Aseptic vs. clean technique;Heart Rate2.personal protective equipment; Oxygen saturation3.safe injection practices; Respiratory Rate4.infection control;5.drug action;6.calculating weight-based drug dosages;7.medication storage, handling, and disposal requirements;8.establishing venous access;9.routes of administration;*These guidelines for vitals collection do not supersedemanufacturer or FDA guidelines. Some medications or patients maywarrant additional collection points for vitals. Refer to medicationguidelines and institutional medication protocols to determine ifmore comprehensive monitoring is indicated.Patients receiving an intravenous infusion must beperiodically observed, per institutional policy, untildischarge. It is recommended to also provide patientswith a way to notify a clinician (e.g., call button).10. use of technical and medical equipment required for medicationpreparation and/or administration;11. pre-medications,The preparation or administration of provideradministered parenteral medications, includingtherapeutic biological products, must be performedby licensed health care professionals within definedscope of practice, or delegated to personnel that havebeen designated by the facility/employer to performthe activity, and educated on and have demonstrated12. expected monitoring;13. hazards, including possible side effects and contraindications,for such therapy;14. when to contact the prescriber; and,15. how to use the reaction management kit and handle unexpectedoutcomes, adverse events, and emergencies.10

Medications must be stored in accordance withmanufacturer product labeling. Expired medicationsand medication preparations that have exceededtheir Beyond-Use Date (BUD) must be disposed ofappropriately.Ensure that all parenteral medication preparations aresafe, consistent, and high-quality. A splash guard at least 12 inches tall is recommended to provide a*physical barrier between the prep area and an adjacent sink. Limit preparations involving more than one active ingredient ina single container for IV/injection administration to pharmacysettings. If more than one medication container is being prepared for asingle patient, prepare each medication container separatelyIf dilution or reconstitution of a parenteral medication occursand label each container prior to the preparation of anyoutside of pharmacy settings, preparation should be performedsubsequent container.by qualified personnel in accordance with manufacturer labelingand within a designated medication preparation area consisting Do not dilute or reconstitute parenteral medications by drawingup the contents into a commercially available, prefilled flushof a hard, non-porous surface that is clean, uncluttered, and freesyringe.from the following conditions: Food in the designated preparation area; Vermin (e.g., insects, rodents) observed in areas within orimmediately adjacent to designated mixing/preparation area; Single-dose vials should be entered no more than 2 times andused or discarded within one hour following initial entry. Dedicate a multi-dose vial to a single patient whenever possible. If multi-dose vials will be used for more than one patient, they Visible microbial contamination (e.g., mold) in the preparation area; Non-microbial contamination in the preparation area (e.g., rust,or designated preparation area and should not enter the patientglass particles or shavings, hairs);treatment area. should be restricted to a centralized medication storage areaMixing/preparation of drugs while construction is underway in an After initial entry, label a multi-dose vial with a Beyond-Use-Dateadjacent area without adequate controls to prevent contamination(BUD) of 28 days (except for vaccines) from date of initial entryof the mixing/preparation environment and drug; and,or manufacturer expiration date, whichever is sooner, and storeaccording to the manufacturer’s label.Obvious contamination sources (e.g., standing water, waterleakage, biohazardous materials or specimen). If the BUD label is missing or illegible, or the sterility of the vial iscompromised or questionable, discard immediately.11

Disinfect critical sites, allowing the disinfectant to remain in1.compounded sterile products prepared outside the aforementionedconditions;contact with the surface for the appropriate contact time (per the disinfectant’s label) or to dry before inserting a device into2.compounded non-sterile products;the vial.3.combining medications or ingredients to create a drug that is not FDAapproved;Preparations of parenteral medications are not considered to be“compounding” and, therefore, exempt from USP Chapter 797 when:4.batch preparation of medications; and/or5.preparation of medications for storage beyond 4 hours from theinitiation of preparation. Mixing, reconstituting, or other such acts occur in accordance with*the directions in the FDA-approved labeling; Diluent to be usedFinal strengthStorage timeContainer closure systemThe starting components are conventionally manufactured sterileproducts; and, No more than 3 different sterile products are used in thepreparation; accordance with US Pharmacopeia (USP) General Chapter 797 pharmacy standards for compounding sterile products.The labeling information includes specific information regarding: Administration begins within 4 hours of initiating preparation; and, Prepared as a single dose for an individual patient.Preparations of parenteral medications that deviate fromIf no such rules exist, such activities should be performed in Administration of parenteral medications should be performed ina safe manner in accordance with FDA-approved manufacturerguidelines and CDC guidance relating to infection controlpractices.Prepared parenteral medications should not be storedfor future use. Administration of parenteral medicationsshould begin immediately, ideally within one hour ofbeginning preparation. If extenuating circumstancespreclude immediate administration, USP Chapter 797 and manufacturer guidelines regarding stability andstorage must be followed; however, storage should notexceed 4 hours.instructions outlined in manufacturer labeling should beperformed in accordance with state Board of Pharmacy rules,including:Adjustments in infusion rate must be as directed by theLIP. The administering clinician may use their clinicaljudgment to decrease the infusion rate if indicated.12

Personnel involved in preparing or administeringparenteral medications must have current Basic LifeSupport Certification.The facility/employer should follow industry guidanceand standards relating to the administration ofintravenous or injectable products, including: Medications, supplies, and equipment to manage ahypersensitivity reaction must be immediately availableduring each administration of a parenteral medication ina Reaction Management Kit. Reaction Management Kitsmust include, at a minimum: Patients Resuscitation Equipment: barrier mask for CPR Breathing Support: Oxygen and delivery system or deviceCDC Guide to Infection Prevention for Outpatient Settings: MinimumExpectations for Safe Care CDC Guidelines for the Prevention of Intravascular Catheter-RelatedInfections, 2011Medications: Epinephrine, corticosteroids, antihistamines, andIV fluidsCDC Safe Injection Practices to Prevent Transmission of Infections to Institute for Safe Medication Practices (ISMP) Safe PracticeGuidelines for Adult IV Push Medications INS Infusion Therapy Standards of Practice that relate to non-Oncology, in-office infusion therapyIt is recommended that Reaction Management Kits also include: Resuscitation Equipment: a manual resuscitation pump or “selfinflating bag” that attaches to the CPR barrier mask, or a bagvalve mask or manual resuscitator, capable of providing positivepressure ventilation.The facility/employer should follow applicable OSHAstandards for healthcare providers, including: Hazard Communication Standard Bloodborne Pathogens Standard Personal Protective Equipment (PPE) Emergency Action Standard13

procedure. ( The American Medical Association ) Label The FDA approved label is the official description of a drug product which includes indication (what the drug is used for); who should take it; adverse events (side effects); instructions for uses in pregnancy, children, and other populations; and safety information for the patient. Labels are