QASP - Patient Elopment System.pdf

ATTACHMENT A - QASP

QUALITY ASSURANCE SURVEILLANCE PLAN (QASP)

The contractor shall be evaluated in accordance with the following QASP.

For: Laboratory Services

Contract Description: Patient Elopement System

Contractor’s Name:

Contracting Officer: Cherisse Hall

Contract Specialist: Isaac Hernandez

Contracting Officer Representative: Chevonne Phelps

1) INTRODUCTION

This Quality Assurance Surveillance Plan (QASP) outlines the strategies and procedures to ensure that the installation of the patient elopement system at the Fayetteville VAMC (FVAMC) meets the specified requirements and achieves the desired quality standards. The plan provides guidance on quality assurance activities and surveillance methods to be employed throughout the project lifecycle.

2) OBJECTIVES

The primary objectives of this QASP are as follows:

a. Ensure that the patient elopement system is installed in accordance with the performance work statement (PWS) requirements.

b. Verify that the system functions as intended, meeting the defined performance standards.

c. Monitor the contractor’s adherence to the specified installation processes and quality control measures.

d. Identify and address any deviations, deficiencies, or non-compliance issues promptly.

e. Maintain open communications and collaboration between FVAMC and the contractor to ensure successful project completion.

3) SURVEILANCE METHODS

a) Inspections: Conduct regular inspections of the installation process, ensuring compliance with the PWS requirements, applicable regulations, and industry best practices. Inspections may include physical site visits, equipment checks, and verification of proper system configuration.

b) Testing and Validation: Perform comprehensive testing and validation of the installed patient elopement system to ensure it meets the defined performance standards. This may involve functional testing, integration testing, and scenario-based testing to simulate real-world situations.

c) Documentation Review: Review all documentation provided by the contractor, including system design and configuration documentation, installation and testing reports, training materials, and any other relevant documentation. Ensure that the documentation accurately reflects the work performed and complies with the specified requirements.

d) User Feedback: Gather feedback from authorized personnel who will be using the patient elopement system. Conduct surveys or interview to assess user satisfaction, system usability, and the effectiveness of training provided by the contractor.

e) The Government will perform surveillance to determine if the contractor exceeds, meets, or does not meet these standards.

4) SURVEILANCE FREQURENCY: Surveillance activities will be conducted at regular intervals throughout the project lifecycle to ensure ongoing quality control and compliance. The frequency of surveillance activities may vary depending on project milestones and criticality. However, the following surveillance activities are recommended:

a) Pre-Installation Surveillance: Conduct an initial review of the contractor’s proposed installation plans, documentation, and qualifications before the actual installation begins.

b) In-Progress Surveillance: Conduct periodic inspections and testing during the installation process to verify compliance with specifications and identify any issues in a timely manner.

c) Post-Installation Surveillance: Perform a comprehensive assessment of the installed patient elopement system, including functional testing, documentation review, and user feedback to ensure that all requirements have been met.

d) Ongoing Surveillance: Establish a post-installation surveillance plan to monitor the system’s performance, collect user feedback, and address any ongoing issues or enhancements.

5) REPORTING AND CORRECTIVE ACTION: Any deviations, deficiencies, or non-compliance issues identified during surveillance activities should be documented and reported to the contractor promptly. The contractor should be given an opportunity to address and rectify the identified issues within a specified timeframe. If corrective actions are not implemented satisfactorily, FVAMC reserves the right to escalate the issue and take appropriate measures to ensure compliance with the PWS requirements. The Government shall use favorable Contractor performance evaluations as incentives and report unfavorable Contractor performance as disincentives. Disincentives shall include documentation of any performance issues.

6) COMMUNICATIN AND COLLABORATION: Maintain open and regular communication channels between FVAMC and the contractor throughout the project. Foster a collaborative environment to address any concerns, provide clarifications, and facilitate the timely resolution of issues. Regular meetings and progress reports should be established to review project status, discuss surveillance findings, and ensure that all parties are aligned with the project objectives.

Signature – Contractor

Signature – Contracting Officer

ATTACHMENT A - QASP