What is Healthcare Value Analysis (HVA)?

Healthcare Value Analysis (HVA) is a systematic process for evaluating the benefit and value of healthcare products and services. It goes beyond just price to consider quality, outcomes, safety, and overall contribution to patient care and organizational goals. It aims to optimize spending and standardize practices.

Why is an HVA checklist important?

An HVA checklist provides a structured approach to HVA, ensuring consistency, preventing overlooked factors, and providing documentation for decision-making. It helps standardize the process across departments, reduces errors, and facilitates cost savings by identifying potential areas for optimization.

Who should use this checklist?

This checklist is designed for a broad range of healthcare professionals involved in procurement, supply chain management, clinical decision-making, and finance, including Value Analysis Committees, Supply Chain Managers, Clinicians (nurses, physicians, therapists), and Finance Team members.

What kind of products/services should be included in an HVA?

Almost any product or service used in healthcare can be evaluated. Common areas include medical supplies, pharmaceuticals, implants, capital equipment, contracts, and outsourced services. The checklist helps guide which items are appropriate for evaluation based on spend, impact, and potential for improvement.

What are the key categories considered in the checklist?

The checklist typically covers areas like clinical necessity, product performance, vendor capabilities, contract terms, total cost of ownership (including hidden costs like labor and waste), patient safety, and impact on quality outcomes.

What does 'Total Cost of Ownership' (TCO) mean in the context of HVA?

TCO considers all costs associated with a product or service over its lifecycle, not just the initial purchase price. This includes factors like installation, maintenance, training, disposal, waste, and potential complications that could increase costs later.

How does standardization benefit healthcare organizations through HVA?

Standardization reduces product variation, simplifies inventory management, streamlines processes, improves staff training efficiency, and can lead to volume discounts from vendors. It also enhances patient safety through consistent product usage.

How can I adapt this checklist to fit my organization's specific needs?

The checklist is a template. You can add, remove, or modify criteria to align with your organization's policies, priorities, and resource constraints. Consider specific clinical specialties or frequently used items for targeted assessments.

What's the difference between Value Analysis and Value Engineering?

While often used interchangeably, Value Engineering (VE) is a more structured methodology that involves a team of experts to functionally analyze a product or service and identify ways to improve its value. Value Analysis is a more general term focusing on overall value assessment.

How do I determine which items to prioritize for HVA?

Prioritize items based on factors like: Total Spend (high-spend items have the greatest potential impact), Clinical Significance (items critical for patient safety or outcomes), Frequency of Use, and Potential for Standardization or Cost Reduction.

Pharmaceutical Container Closure Integrity Testing Checklist | Pharmaceutical Templates

Test Planning & Preparation

1 of 10

Ensuring proper test scope, methodology selection, and equipment readiness.

Test Objective(s)

Test Methodology

Vacuum Decay

Pressure Decay

Helium Leak Testing

Direct Leak Testing

Sample Size (Units)

Planned Test Start Date

Planned Test End Date

Acceptance Criteria Source

Company Standard

Regulatory Guidance

Client Requirement

Equipment Calibration & Verification

2 of 10

Confirming accuracy and reliability of testing equipment.

Last Calibration Date

Calibration Frequency (in months)

Temperature Reading During Calibration (°C)

Pressure Reading During Calibration (PSI)

Calibration Standard Used

NIST traceable standard

In-house standard

Other - Specify in Long Text

Calibration Details/Comments (if 'Other' selected above)

Calibration Certificate (PDF)

Technician Signature

Sample Selection & Handling

3 of 10

Ensuring representative samples are selected and handled appropriately.

Number of Samples Selected

Sampling Method

Random Sampling

Stratified Sampling

Judgmental Sampling

Sample Collection Date

Sample Collection Time

Sample Collection Location

Sample Description (Appearance, Condition)

Container Type

Glass

Plastic

Metal

Sample Collector Signature

Leak Testing Procedure Adherence

4 of 10

Verifying adherence to established leak testing protocols (e.g., vacuum decay, pressure decay, helium leak testing).

Leak Testing Method

Vacuum Decay

Pressure Decay

Helium Leak Testing

Other (Specify)

Vacuum Level (mmHg)

Pressure (psi)

Leak Rate Limit (cc/min)

Test Duration (minutes)

Specific Procedure Steps Followed (Detailed)

Procedure Version Used

Version 1.0

Version 1.1

Version 1.2

Other (Specify)

Operator Signature

Data Acquisition & Recording

5 of 10

Accurate and complete recording of test data and observations.

Vacuum Decay Test Pressure (mmHg)

Vacuum Decay Test Duration (seconds)

Leak Rate (cc/second)

Date of Test

Time of Test Start

Observations During Testing

Test Result (Pass/Fail)

Pass

Fail

Operator Signature

Results Evaluation & Acceptance Criteria

6 of 10

Comparison of results against predetermined acceptance criteria and assessment of container closure integrity.

Leak Rate (ml/min)

Vacuum Decay Constant (k-value)

Method Used (e.g., Vacuum Decay, Pressure Decay, Helium)

Vacuum Decay

Pressure Decay

Helium Leak Testing

Other - Specify in Long Text

Detailed Result Commentary

Pass/Fail Determination

Pass

Fail

Conditional - Requires Further Investigation

Justification for Pass/Fail Determination

Date of Result Evaluation

Evaluator Signature

Deviation Management & Investigation

7 of 10

Documentation and investigation of any deviations from expected results or acceptance criteria.

Detailed Description of Deviation

Date of Deviation Occurrence

Time of Deviation Occurrence

Severity Level (e.g., Minor, Moderate, Major)

Minor

Moderate

Major

Quantity Affected (if applicable)

Root Cause Analysis

Corrective Action Plan

Corrective Action Completion Date

Investigator Signature

Report Generation & Review

8 of 10

Compilation of test results and conclusions into a comprehensive report for review and approval.

Executive Summary of Findings

Number of Containers Tested

Number of Failed Containers

Overall Conclusion (Pass/Fail/Conditional)

Pass

Fail

Conditional

Detailed Description of Anomalies (if any)

Report Issue Date

Reviewer Signature

Supporting Data/Graphs (optional)

Maintenance and Cleaning of Equipment

9 of 10

Ensuring equipment is properly maintained and cleaned after testing.

Last Cleaning Date

Cleaning Procedure Followed (Detailed Description)

Cleaning Solution Concentration (%)

Areas Cleaned (Check all that apply)

Exterior Surfaces

Sensor Ports

Internal Components

Fluid Pathways

Power Supply

Cleaning Verification Photos (Optional)

Cleaning Effectiveness Verification Method

Visual Inspection

Residue Testing

Other (Specify)

Other Method Description (if selected)

Documentation Review and Traceability

10 of 10

Review of all associated documentation for completeness and traceability.

Document Review Date

Summary of Document Review Findings

Document Status

Approved

Rejected

Revised