QASP.docx
DOCX document 24 KB Posted
- Solicitation number
- 36C25526Q0054
About this file
This document is a Quality Assurance Surveillance Plan (QASP) for IV Room Testing and Personnel Testing at VISN 15 Medical Centers. The plan outlines comprehensive surveillance methods including direct observation, periodic inspection, random sampling, performance metrics review, contractor self-reporting, and customer feedback to ensure compliance with USP Chapter 797 and USP Chapter 800 standards. Surveillance will focus on critical areas such as PEC testing, clean room certification, HEPA filter replacement, environmental wipe sampling, and personnel competency assessment, with quarterly reviews and performance metrics evaluating completion rates, test result accuracy, USP guideline compliance, documentation quality, emergency response time, and laboratory certification status.
The associated federal contract opportunity is a VA Heartland Health Care Network solicitation (36C25526Q0054) requiring testing and certification of primary engineering controls (PECs) and clean rooms used for compounded sterile preparations across VISN 15 facilities. The scope includes certifying biological safety cabinets, laminar airflow workbenches, compounding aseptic containment isolators, and other specialized medical equipment, along with comprehensive personnel training and evaluation for compounding sterile preparations in accordance with current United States Pharmacopeia guidelines.
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Other files
| File | Type | Posted |
|---|---|---|
| 36C25526Q0054.pdf | ||
| PRICE SCHEDULE .xlsx | XLSX spreadsheet | |
| 852.19-76 VA NOTICE OF LIMITATIONS ON SUBCONTRACTING.pdf |
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Text version
D.2 Quality Assurance Surveillance Plan (QASP) For: IV Room Testing and Personnel Testing Facility: VISN 15 Medical Centers Contract Number: TBD
COR: TBD
Period of Performance: TBD
1. Purpose This QASP outlines the surveillance methods and frequency used to ensure contractor compliance with the performance requirements for IV Room Certification and Personnel Testing in accordance with USP Chapter 797, USP Chapter 800 and the Performance Work Statement (PWS).
2. Surveillance Methods
| Method |
| Description |
| Direct Observation |
| Real-time monitoring of contractor activities such as sample collection, personnel instruction and testing. |
| Periodic Inspection |
| Scheduled reviews of reports, and certifications. |
| Random Sampling |
| Unannounced checks of procedures, documentation, and equipment. |
| Performance Metrics Review |
| Analysis of system reports, and compliance with USP. |
| Contractor Self- Reporting |
| Review of contractor-submitted documentation and quality control reports. |
| Customer Feedback |
| Input from VA staff and stakeholders on service quality and responsiveness. |
3. Surveillance Frequency
| Performance Area |
| Surveillance Method |
| Frequency |
| PEC Testing |
| Direct Observation / Documentation Review |
| After each sample tested |
| Clean Room Certification |
| Direct Observation / Documentation Review |
| After each certification |
| HEPA Filter Replacement |
| Documentation Review |
| Quarterly |
| Environmental Wipe Sampling |
| Documentation Review / Random Sampling |
| Quarterly |
| Certification and Environmental Results Reporting |
| Documentation Review |
| Quarterly |
| Personnel Competency Assessment/Training |
| Periodic Inspection of Reports |
| Quartely |
4. Performance Metrics The following metrics will be used to evaluate contractor performance:
· Completion rate of PEC Testing and Certification
· Accuracy and timeliness of test results
· Compliance with USP Guidelines
· Documentation completeness and accuracy
· Emergency response time
· Laboratory certification status
· Quality control findings and corrective actions
5. Roles and Responsibilities
· Contracting Officer (CO): Maintains contractual authority and approves corrective actions.
· Contracting Officer’s Representative (COR): Conducts surveillance, documents findings, and communicates with the contractor.
· Pharmacy Manager: Provides technical oversight and supports compliance verification.
<After award, both the contractor’s Program Manager, COR, and CO will sign this document.>
Signature – Contractor Program Manager
Signature – Contracting Officer’s Representative
Signature – Administrative Contracting Officer
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