Foundations of Clinical Practice and Specialized Population Management
Establishes the foundational principles governing the administration of infusion therapy and the management of vascular access devices across all specialized patient populations, including pediatric, neonatal, obstetric, and geriatric cohorts.
Foundations of Clinical Practice and Specialized Population Management Policy
1. Policy Statement
It is the policy of this organization that all infusion therapy and vascular access device (VAD) management shall be governed by a structured hierarchy of safety, ethics, and regulatory compliance. All clinicians involved in the prescription, insertion, maintenance, or removal of vascular access devices shall adhere to evidence-based, population-specific protocols that account for the unique physiological, developmental, and clinical requirements of pediatric, neonatal, obstetric, and geriatric patient populations. No patient shall receive infusion therapy through a vascular access device without the clinician first performing a population-appropriate risk assessment and applying the corresponding clinical safeguards defined within this policy.
2. Purpose
This policy exists to:
- Establish the foundational clinical principles that govern all vascular access care within the organization, ensuring a uniform standard of safety across all patient populations.
- Define population-specific clinical requirements for pediatric, neonatal, obstetric, and geriatric patients that reflect known physiological differences and elevated risk profiles.
- Ensure that all infusion therapy decisions are traceable to formal institutional protocols, evidence-based guidelines, and written provider orders.
- Protect patient autonomy and dignity by mandating ethical advocacy, requiring that all clinical decisions prioritize safety over efficiency and remain free from commercial influence or conflicts of interest.
- Reduce preventable harm by requiring clinicians to modify standard approaches based on age-specific, condition-specific, and population-specific clinical evidence.
3. Scope
This policy applies to:
- All licensed clinical personnel who participate in the prescription, insertion, assessment, maintenance, troubleshooting, or removal of any vascular access device, including but not limited to Registered Nurses (RNs), Licensed Practical/Vocational Nurses (LPN/LVNs), Advanced Practice Registered Nurses (APRNs), Physicians (MDs/DOs), Physician Assistants (PAs), Vascular Access Specialists, Infusion Nurse Specialists, and Unlicensed Assistive Personnel (UAPs) operating under delegation.
- All vascular access routes, including peripheral intravenous (PIV), central venous access devices (CVADs), peripherally inserted central catheters (PICCs), midline catheters, intraosseous (IO) access, subcutaneous infusion, and epidural/intrathecal routes.
- All clinical settings within the organization, including inpatient acute care units, intensive care units, perioperative areas, emergency departments, ambulatory infusion centers, home health services, and skilled nursing facilities operating under organizational agreements.
- All patient populations, with specific enhanced requirements for neonatal (0–28 days), pediatric (29 days–17 years), obstetric, and geriatric (≥65 years) patients.
4. Policy Requirements
4.1 Core Principles of Vascular Care
4.1.1 Regulatory Alignment. All clinicians shall adhere to the legislative and regulatory framework of their governing jurisdiction, including federal and state statutes, professional licensing board regulations, and applicable accreditation standards (e.g., The Joint Commission, CMS Conditions of Participation, state Nurse Practice Acts). In the event of conflict between organizational policy and regulatory requirements, the more restrictive standard shall prevail.
4.1.2 Organizational Standards Compliance. Every clinical action related to vascular access shall be traceable to a formal institutional policy, standardized protocol, approved clinical pathway, or a written provider order. No clinician shall perform a vascular access procedure without verifying that an active, authorized order exists in the patient’s health record.
4.1.3 Ethical Advocacy. Clinicians are the primary defenders of patient autonomy and dignity throughout all vascular access encounters. Clinical decisions shall prioritize patient safety over procedural efficiency, departmental throughput, or institutional convenience. All decisions regarding device selection and product utilization shall remain free from commercial influence, undisclosed conflicts of interest, or manufacturer preference that lacks supporting clinical evidence. Clinicians shall demonstrate cultural humility and apply culturally competent communication strategies to all patient and family interactions, recognizing that health literacy, language, cultural beliefs, and health disparities meaningfully influence clinical outcomes.1
4.1.4 Hierarchy of Safety. In all clinical decision-making, the following hierarchy shall be observed: (a) patient safety, (b) evidence-based clinical effectiveness, (c) patient preference and comfort, (d) operational efficiency, (e) cost-effectiveness. No lower-priority consideration shall override a higher-priority one.
4.2 Pediatric and Neonatal Considerations
4.2.1 DEHP Exposure Mitigation. All administration sets, extension tubing, and infusion-related disposables used in neonatal and pediatric patients shall be free of Di(2-ethylhexyl)phthalate (DEHP). The Supply Chain and Clinical Engineering departments shall maintain a current list of DEHP-free products approved for pediatric use. Any deviation requires written approval from the attending neonatologist or pediatric intensivist and must be documented in the patient’s health record with a clinical justification.
4.2.2 Volume Accuracy and Infusion Precision. Infusion pumps used for neonatal and pediatric patients shall be capable of delivering precise, low-volume infusion rates with incremental accuracy of ≤0.1 mL/hour. All dosing calculations shall be strictly based on the patient’s verified weight (in kilograms), age, or body surface area (BSA) as clinically indicated. Independent double-verification of all high-alert medication calculations is mandatory prior to infusion initiation.
4.2.3 Dermatologic Fragility in Preterm Infants. In preterm infants (gestational age <37 weeks), clinicians shall exercise heightened vigilance regarding skin integrity at and surrounding the vascular access site. The following safeguards apply:
- Chlorhexidine gluconate (CHG) use requires a patient-specific risk-benefit determination in neonates <2 months of age or weighing <1500 grams, with documentation of the clinical rationale.2
- Skin shall be monitored at minimum every two (2) hours for signs of chemical irritation, systemic absorption, or mechanical injury from adhesives.
- Only skin-protective barrier products approved by the Neonatal Clinical Practice Committee shall be used for dressing securement.
4.2.4 Difficult Intravenous Access (DIVA) Protocols. For pediatric patients identified as having Difficult Intravenous Access—defined as two or more failed peripheral insertion attempts by a competent clinician—the following escalation pathway shall be activated:345
- Ultrasound-guided peripheral IV insertion shall be attempted by a clinician with documented competency in pediatric ultrasound-guided vascular access.
- Near-infrared vein visualization technology shall be available and offered as an adjunctive tool.
- If peripheral access cannot be established after escalation, a formal vascular access consultation shall be initiated to evaluate the appropriateness of alternative devices (e.g., midline catheter, PICC, or central venous access).
4.2.5 Non-Traditional Vascular Access Sites. When standard peripheral sites are exhausted in pediatric patients, advanced techniques including but not limited to the supraclavicular approach to the brachiocephalic vein, tunneled femoral cannulation, or intraosseous access may be indicated. These procedures shall only be performed by credentialed practitioners with specific privileging for the technique, under direct or indirect physician supervision as defined by institutional credentialing policy.6
4.2.6 Pediatric Pain Management and Comfort. Non-pharmacologic comfort measures shall be employed for all pediatric vascular access procedures, including but not limited to age-appropriate distraction techniques, child life specialist involvement, topical anesthetic agents (e.g., lidocaine-prilocaine cream, vapocoolant spray), sucrose pacifiers for neonates, and parental presence during the procedure when clinically appropriate. The goal is to mitigate procedural anxiety, reduce the development of long-term needle phobia, and minimize medical trauma.7
4.3 Obstetric Considerations
4.3.1 Dual Safety Focus. All vascular access decisions for pregnant patients shall account for both maternal hemodynamic changes and potential fetal impact. Clinicians shall recognize that pregnancy induces a physiological hypercoagulable state, expanded blood volume, and altered pharmacokinetics that affect device selection, site management, and medication administration.8
4.3.2 PICC Risk Management in Pregnancy. Peripherally Inserted Central Catheters (PICCs) in pregnant patients are associated with elevated rates of upper extremity deep vein thrombosis (UEDVT) and catheter-related bloodstream infection (CRBSI) due to the hypercoagulable state of pregnancy.9 Before a PICC is placed in a pregnant patient, the ordering provider shall document the clinical necessity, the absence of suitable alternatives, and the plan for thromboprophylaxis and monitoring. An interprofessional risk-benefit discussion involving the obstetric provider, vascular access team, and maternal-fetal medicine (when available) shall be documented.
4.3.3 Labor and Delivery IV Management. For low-risk obstetric patients in active labor, an “indication-only” approach to peripheral IV insertion is preferred over routine prophylactic placement, provided the facility has demonstrated rapid-response capability for emergent vascular access (defined as the ability to establish IV access within five minutes of identified need).101112 The decision to defer routine IV placement shall be a collaborative determination between the obstetric provider and the labor and delivery nursing team, documented in the health record.
4.3.4 Nutritional Support in Hyperemesis Gravidarum. In patients with Hyperemesis Gravidarum requiring nutritional support beyond standard antiemetic therapy and IV hydration, enteral feeding via nasogastric or nasoduodenal tube is the first-line intervention.1314 Parenteral nutrition (PN) shall be reserved for cases where enteral methods have been documented as attempted and failed or are clinically contraindicated. When PN is initiated, daily metabolic laboratory monitoring (including electrolytes, glucose, hepatic function, and triglycerides) and strict central line site care are mandatory.
4.4 Geriatric Considerations
4.4.1 Vascular Fragility Recognition. Clinicians shall recognize that aging introduces structural changes in the vasculature, including thinning of the dermal layers, reduced subcutaneous tissue, increased vessel tortuosity, and thickening of the tunica intima. These changes result in increased vessel fragility, elevated risk of hematoma formation, and higher rates of infiltration and extravasation.151617 Vascular access site selection, catheter gauge, insertion technique, and securement methods shall be modified accordingly.
4.4.2 Cognitive and Functional Assessment for Home Infusion. Before authorizing discharge with home-based infusion therapy for geriatric patients, the responsible clinician shall complete and document an assessment of the patient’s manual dexterity, visual acuity, cognitive status (using a validated screening tool), and ability to identify and report complications.181920 If the patient does not meet the minimum functional criteria, a caregiver who meets these criteria must be identified, trained, and documented as the responsible party for device management.
4.4.3 Polypharmacy Management. Geriatric patients receiving infusion therapy shall have a comprehensive medication reconciliation performed at the time of vascular access device insertion and at every subsequent care transition (admission, transfer, discharge). The reconciliation shall include all prescription medications, over-the-counter agents, and supplements, with specific attention to drug-drug interactions, nephrotoxic combinations, and agents that affect coagulation.2122232425
4.4.4 Dialysis Access Considerations. The selection of dialysis access type in geriatric patients (Arteriovenous Fistula [AVF], Arteriovenous Graft [AVG], or Central Venous Access Device [CVAD]) shall be individualized through a shared decision-making process that considers life expectancy, functional status, frailty index, vascular mapping results, and patient preference. While AVFs are generally preferred per national guidelines, this preference shall not override an individualized clinical assessment that identifies a different device as more appropriate for the specific patient.26272829
4.5 Population-Specific Risk Assessment and Documentation
4.5.1 All clinicians shall complete a population-specific risk assessment prior to initiating vascular access in any patient who falls within one or more of the specialized populations defined in this policy (neonatal, pediatric, obstetric, geriatric). The assessment shall be documented in the electronic health record using the organization’s standardized vascular access assessment form.
4.5.2 The risk assessment shall include, at minimum: patient population classification, population-specific risk factors identified, modifications to standard protocol warranted, rationale for device selection, and any population-specific monitoring parameters ordered.
4.5.3 For patients who fall into more than one specialized population category (e.g., a geriatric pregnant patient), the clinician shall apply the most restrictive safety requirements from each applicable population category.
5. Compliance
5.1 Monitoring. Compliance with this policy shall be monitored through a combination of concurrent clinical audits (performed by Vascular Access Specialists and Charge Nurses during routine rounding), retrospective chart reviews (conducted quarterly by the Quality and Patient Safety Department), and analysis of adverse event and near-miss reports related to vascular access complications.
5.2 Key Performance Indicators. The following metrics shall be tracked and reported to the Vascular Access Governance Committee on a quarterly basis:
- Percentage of pediatric/neonatal patients receiving DEHP-free infusion sets.
- DIVA protocol activation rate and first-attempt success rate following escalation.
- Rate of PICC-related thrombotic events in obstetric patients.
- Completion rate of cognitive/functional assessments prior to geriatric home infusion discharge.
- Medication reconciliation completion rate for geriatric infusion patients at each care transition.
5.3 Enforcement. Non-compliance with this policy shall be addressed through the organization’s progressive corrective action process. Depending on the severity and frequency of the violation, corrective actions may include individual coaching and re-education, a formal performance improvement plan, competency re-validation, restriction of clinical privileges, or disciplinary action up to and including termination. Clinicians who identify systemic barriers to compliance are encouraged to report these through the organization’s safety reporting system without fear of retribution, consistent with the organization’s Just Culture framework.
5.4 Reporting. Adverse events, near-misses, and sentinel events related to vascular access in specialized populations shall be reported through the organization’s electronic safety reporting system within twenty-four (24) hours of discovery. Events meeting criteria for external reporting shall be escalated to Risk Management and reported to applicable regulatory agencies (e.g., state health department, FDA MedWatch) within the timeframes required by law.
6. Exceptions
6.1 Exceptions to this policy may be granted only in the following circumstances:
- Emergent clinical situations where strict adherence to this policy would result in a delay that poses an immediate threat to patient life or limb. In such cases, the treating provider shall document the clinical rationale for the exception in the health record within twelve (12) hours of the event.
- Formal exception requests for non-emergent situations shall be submitted in writing to the Vascular Access Governance Committee via the Exception Request Form (FORM-VA-EXC-001). The request must include the specific policy requirement for which an exception is sought, the clinical justification, the proposed alternative practice, and the risk mitigation measures that will be employed.
6.2 The Vascular Access Governance Committee shall review and render a decision on exception requests within ten (10) business days. Approved exceptions are time-limited (not to exceed twelve months) and must include a re-evaluation date. All approved exceptions shall be documented in the policy exception log maintained by the Quality Department.
6.3 No exception shall be granted that would result in a violation of federal or state law, professional licensing board regulations, or accreditation standards.
7. Related Documents
- SOP-VA-001: Peripheral Intravenous Catheter Insertion and Maintenance
- SOP-VA-002: Central Vascular Access Device (CVAD) Insertion and Management
- SOP-VA-003: Intraosseous Access: Indications and Procedure
- SOP-VA-010: Pediatric Difficult Intravenous Access (DIVA) Escalation Protocol
- SOP-VA-011: Neonatal Skin Integrity and Vascular Access Site Care
- POL-002: Scope of Practice and Professional Boundaries in Infusion Therapy
- POL-007: Competency and Competency Validation in Vascular Access
- POL-011: Informed Consent for Vascular Access Procedures
- POL-012: Documentation in the Health Record
- CDC Guidelines for the Prevention of Intravascular Catheter-Related Infections
- AORN Guidelines for Perioperative Practice (Vascular Access Sections)
- Joint Commission National Patient Safety Goals: Infection Prevention
- FDA Safety Communication: DEHP Exposure in Medical Devices
- Organizational Formulary: Approved DEHP-Free Product List
- FORM-VA-EXC-001: Policy Exception Request Form
8. Revision History
| Version | Date | Author(s) | Description of Change |
|---|---|---|---|
| 1.0 | 2026-02-01 | D. Woo, M. Stern, I.M. Wright | Initial policy creation and approval |
| — | — | — | Scheduled review date: 2027-02-01 |
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