Evidence-Based Selection and Clinical Monitoring Standards Policy

1. Policy Statement

It is the policy of this organization that all clinical decisions regarding the selection of vascular access devices, antiseptic agents, dressing materials, securement products, and infusion technologies shall be rooted in demonstrated patient outcomes derived from the highest quality available clinical evidence. Product selection shall not be driven by habit, anecdotal experience, individual clinician preference, or manufacturer influence. Furthermore, all vascular access devices in active use shall be subject to continuous, systematic clinical monitoring with standardized documentation at defined intervals to enable early detection and management of complications.

2. Purpose

This policy exists to:

• Ensure that vascular access product procurement and clinical utilization are transparent, evidence-based, and prioritize patient safety and complication reduction over cost-savings alone or commercial relationships.
• Establish a conflict-of-interest framework that mitigates any commercial interests that could bias device selection or patient care decisions.
• Define the minimum clinical monitoring parameters, assessment intervals, and documentation requirements for all vascular access devices from insertion through removal.
• Require standardized patient and caregiver education as a clinical intervention that directly reduces vascular access-related risk.
• Establish specialized monitoring protocols for high-risk clinical scenarios, including hemodialysis access and parenteral nutrition.

3. Scope

This policy applies to:

• All clinical personnel involved in the selection, ordering, insertion, management, assessment, or removal of vascular access devices.
• All personnel involved in the procurement, evaluation, or clinical trial of vascular access products, including Supply Chain, Pharmacy, Biomedical Engineering, and Clinical Education departments.
• All vascular access devices and infusion-related products, including peripheral IV catheters, midline catheters, PICCs, non-tunneled and tunneled central venous catheters, implanted ports, intraosseous devices, antiseptic agents, dressing materials, securement devices, needleless connectors, extension sets, and infusion pumps.
• All clinical settings within the organization.

4. Policy Requirements

4.1 Evidence-Based Decision Making (EBDM) for Product Selection

4.1.1 Primary Evidence Standard. All decisions regarding the adoption, continuation, or discontinuation of vascular access products shall be informed by the highest quality available clinical evidence, prioritized as follows: (a) systematic reviews and meta-analyses, (b) randomized controlled trials (RCTs), (c) multi-center observational studies, (d) single-center studies, (e) expert consensus guidelines from recognized professional organizations. Manufacturer-funded studies shall be evaluated critically and shall not be the sole basis for product adoption.

4.1.2 Product Evaluation Committee. The organization shall maintain a standing Product Evaluation Committee (PEC) charged with reviewing all proposed changes to the vascular access product formulary. The PEC shall include representation from Vascular Access Specialists, Infection Prevention, Pharmacy, Supply Chain, Nursing Education, and at least one physician champion. All PEC decisions shall be documented with the evidence reviewed, the decision rationale, and the dissenting opinions (if any).

4.1.3 Outcome-Driven Selection. Product evaluation shall prioritize the reduction of patient complications—including phlebitis, infiltration, extravasation, catheter-associated bloodstream infection (CABSI), catheter occlusion, and venous thromboembolism—while maintaining cost-effectiveness. A product that demonstrates superior clinical outcomes shall be preferred over a less expensive alternative that produces inferior outcomes, unless the clinical difference is not statistically or clinically significant.

4.1.4 Conflict of Interest Management. All members of the Product Evaluation Committee and all clinicians involved in product evaluation, selection, or clinical trial participation shall complete and submit an annual Conflict of Interest Disclosure Form. The following requirements apply:

• No clinician shall participate in a product evaluation decision for a product manufactured by a company from which they receive personal compensation, consulting fees, speaker honoraria, research funding, or equity.
• Manufacturer-sponsored meals, gifts, or educational events shall be disclosed and shall not influence product selection.
• Clinical trials conducted within the organization shall be reviewed and approved by the Institutional Review Board (IRB) and shall comply with all applicable research ethics standards.

4.1.5 Product Standardization. The organization shall maintain a standardized vascular access product formulary. Off-formulary product requests must be submitted to the PEC with a clinical justification and supporting evidence. Clinicians shall not unilaterally substitute products outside the approved formulary without PEC authorization except in documented emergent circumstances.

4.2 Clinical Assessment and Monitoring Standards

4.2.1 Monitoring Obligation. Every vascular access device in active use shall be subject to systematic clinical monitoring from the time of insertion through removal and post-removal assessment. The clinician responsible for the patient shall ensure that monitoring is performed, documented, and acted upon at the intervals defined in this policy.

4.2.2 Site Integrity Assessment. Visual inspection and palpation of the vascular access insertion site shall be performed at the following minimum intervals:

• Peripheral IV catheters: Every four (4) hours during continuous infusion; before and after each intermittent infusion; and immediately upon patient report of pain, swelling, or discomfort at the site.
• Midline catheters: Every four (4) hours during continuous infusion; every twelve (12) hours for devices accessed intermittently.
• Central venous access devices (CVADs), including PICCs: At minimum once per nursing shift (every eight to twelve hours) for stable inpatients; daily for patients in home care or long-term care; and immediately upon any clinical concern.
• Intraosseous devices: Continuous monitoring during active infusion; assessment every fifteen (15) minutes for the first hour, then every thirty (30) minutes thereafter.

4.2.3 Assessment Parameters. Each site assessment shall evaluate and document the following:

• Insertion site appearance: Presence or absence of erythema, edema, induration, warmth, tenderness, purulent or non-purulent drainage, and skin integrity around the dressing.
• Dressing integrity: Intact, clean, dry, and adherent. Date of last dressing change and date of next scheduled change.
• Securement device integrity: Functioning as intended without migration.
• External catheter length: Measured and compared to the documented insertion length to detect migration.
• Patient-reported symptoms: Pain, burning, tingling, numbness, or any new symptom associated with the device.

4.2.4 Patency Assessment. The functionality of the vascular access device shall be confirmed at each assessment by evaluating: the ability to flush without resistance (using the appropriate flush solution and technique per organizational protocol), the presence or absence of a brisk blood return (where applicable and per device type), and the ability to infuse at the prescribed rate.

4.2.5 Patient Response Monitoring. Clinicians shall evaluate the systemic effect of the infusate at each assessment, including monitoring for allergic or anaphylactic reactions, fluid volume overload or deficit, electrolyte imbalances, infusion-related fever or rigors, and medication-specific adverse effects.

4.2.6 Standardized Grading Scales. The organization shall adopt and use validated, standardized grading scales for the assessment of vascular access complications:

• Phlebitis: A validated phlebitis scale (e.g., the Visual Infusion Phlebitis [VIP] score) shall be used at every peripheral IV site assessment.
• Infiltration and Extravasation: A validated infiltration scale shall be used when infiltration is suspected or confirmed.
• Grading results shall be documented in the EHR using discrete data fields to enable aggregate analysis.

4.3 Patient and Caregiver Education

4.3.1 Education as Clinical Intervention. Patient and caregiver education regarding vascular access device management is a required clinical intervention that directly reduces complication risk. Education shall be initiated at the time of device insertion and reinforced at every subsequent care encounter.

4.3.2 Developmental and Literacy Appropriateness. Educational content shall be tailored to the patient’s age, developmental stage, cognitive status, preferred language, and health literacy level. Written materials shall be available at or below a sixth-grade reading level and in the languages most commonly spoken within the patient population served.

4.3.3 Assent Process for Minors. While legal consent for vascular access is obtained from the parent or legal guardian, school-aged children (generally ages 7 and older) and adolescents shall be involved in a developmentally appropriate assent process that respects their growing autonomy. The assent discussion shall be documented.

4.3.4 Home-Based Readiness Verification. Before discharge with an indwelling vascular access device, the responsible clinician shall verify and document the patient’s (or designated caregiver’s) ability to: (a) perform aseptic technique during dressing changes, tubing changes, and infusion bag changes; (b) identify the signs and symptoms of infection, catheter migration, infiltration, and thrombosis; (c) demonstrate emergency procedures, including how to clamp a broken or damaged catheter and how to access emergency medical services; and (d) operate the infusion pump (if applicable) and troubleshoot common alarms.

4.4 Specialized Monitoring Protocols

4.4.1 Hemodialysis Access Monitoring. For patients with an Arteriovenous Fistula (AVF) or Arteriovenous Graft (AVG):

• A physical examination including assessment for a palpable thrill and an audible bruit shall be performed and documented at minimum once per nursing shift.
• A strict “No Blood Pressure / No Venipuncture / No Tourniquet” protocol shall be enforced for the extremity containing the hemodialysis access. This restriction shall be communicated via a visible wristband on the affected extremity, a flag in the electronic health record, and verbal handoff at every care transition.
• Any change in the quality of the thrill or bruit, new-onset swelling of the extremity, pain at the access site, or signs of infection shall be reported immediately to the nephrology team.

4.4.2 Parenteral Nutrition (PN) Monitoring. When parenteral nutrition is administered through a central vascular access device:

• Daily laboratory monitoring shall include serum electrolytes (sodium, potassium, chloride, bicarbonate, calcium, magnesium, phosphorus), blood glucose, hepatic function panel, and triglyceride levels, until the patient is metabolically stable.
• Strict aseptic technique shall be observed during all PN bag changes. PN shall not be infused through a multi-lumen catheter lumen used for other medications unless no alternative exists and the clinical rationale is documented.
• Central line site care shall follow the organization’s CVAD maintenance bundle without exception.

4.5 Documentation Requirements for Monitoring

4.5.1 All clinical assessments and monitoring activities required by this policy shall be documented in the electronic health record in a timely fashion—defined as within one (1) hour of the assessment for routine assessments and immediately for urgent findings.

4.5.2 Each documentation entry shall include, at minimum: the date and time of assessment, the identity and credentials of the assessing clinician, findings for each required assessment parameter (site integrity, patency, patient response), the grading scale score (where applicable), any interventions performed, and the plan of care.

4.5.3 Line Necessity Review. For all CVADs, the responsible clinician shall document daily whether the central line continues to be clinically necessary. If the line is no longer necessary, the clinician shall initiate a removal order or escalate to the prescribing provider.

5. Compliance

5.1 Monitoring. Compliance shall be monitored through quarterly chart audits of vascular access site assessment documentation completeness and timeliness, monthly review of line necessity documentation completion rates for CVADs, annual review of Product Evaluation Committee conflict-of-interest disclosures, concurrent observational audits of monitoring practices by Vascular Access Specialists during clinical rounding, and review of complication rates (phlebitis, infiltration, CABSI) as outcome indicators of monitoring effectiveness.

5.2 Key Performance Indicators.

• Site assessment documentation compliance rate (target: ≥95%).
• Daily line necessity documentation rate for CVADs (target: 100%).
• CABSI rate per 1,000 central line days.
• Peripheral IV complication rate (phlebitis, infiltration) per 1,000 catheter days.
• PEC conflict-of-interest disclosure completion rate (target: 100%).
• Patient/caregiver education documentation rate prior to discharge with VAD (target: 100%).

5.3 Enforcement. Non-compliance with monitoring and documentation requirements shall be addressed through the organization’s progressive corrective action process. Repeated failure to perform required site assessments or line necessity reviews may result in restriction of the clinician’s authority to manage vascular access devices pending completion of a remediation plan.

6. Exceptions

6.1 Exceptions to defined assessment intervals may occur in the following circumstances: the patient is in an emergent resuscitation where continuous monitoring is occurring by default, the patient refuses the assessment after education regarding risks (documented in the health record), or the patient is undergoing a procedure that precludes access to the device site (documented with a plan for assessment upon completion).

6.2 Exceptions to product formulary standardization require written approval from the Product Evaluation Committee via the Off-Formulary Product Request Form.

7. Related Documents

• SOP-VA-030: Peripheral IV Site Assessment and Phlebitis Scoring Procedure
• SOP-VA-031: Central Line Site Assessment and Dressing Change Procedure
• SOP-VA-032: Hemodialysis Access Monitoring Procedure
• SOP-VA-033: Parenteral Nutrition Administration and Monitoring Procedure
• SOP-VA-034: Product Evaluation Committee Charter and Operating Procedures
• POL-001: Foundations of Clinical Practice and Specialized Population Management
• POL-012: Documentation in the Health Record
• POL-009: Patient Education in Infusion Therapy
• Conflict of Interest Disclosure Form (FORM-PEC-COI-001)
• Off-Formulary Product Request Form (FORM-PEC-OFR-001)
• CDC Guidelines for the Prevention of Intravascular Catheter-Related Infections
• Organizational Infection Prevention and Control Plan

8. Revision History