QASP GCP Monitoring 231102.docx
DOCX document 37 KB Posted
- Solicitation number
- 36C24E24Q0043
About this file
This document is a Quality Assurance Surveillance Plan (QASP) that outlines the procedures and guidelines the Department of Veterans Affairs (VA), Cooperative Studies Program (CSP), Site Monitoring, Auditing and Resource Team (SMART) will use to monitor the contractor's performance for the GCP Monitoring contract.
The QASP defines the performance management approach, roles and responsibilities, required performance standards and quality levels, surveillance techniques, customer feedback mechanisms, and quality assurance documentation requirements. It also covers analysis of quality assurance assessments, performance reporting, and review/resolution processes. The key performance requirements include site visits, reporting, document reviews, and hourly GCP quality assurance support services, with specified acceptable quality levels and surveillance methods. The QASP will be used in conjunction with the Performance Work Statement for this contract.
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Other files
| File | Type | Posted |
|---|---|---|
| 36C24E24Q0043 0001_1.docx | DOCX document | |
| 36C24E24Q0043 0001.docx | DOCX document | |
| 36C24E24Q0043_1.docx | DOCX document | |
| Attachment 3 Pricing Sheet.xlsx | XLSX spreadsheet | |
| Attachment 1 PWS GCP Monitoring5-10.docx | DOCX document | |
| Attachment 2 Clauses_Provisions_Quote Submit_Eval.docx | DOCX document |
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QUALITY ASSURANCE SURVEILLANCE PLAN (QASP)
GCP Monitoring
1.0 INTRODUCTION
This quality assurance surveillance plan (QASP) is pursuant to the requirements listed in the performance work statement (PWS) entitled GCP Monitoring. This plan sets forth the procedures and guidelines the Department of Veterans Affairs, Cooperative Studies Program (CSP), Site Monitoring, Auditing and Resource Team (SMART) will use in ensuring the required performance standards or services levels are achieved by the contractor.
2.0 Purpose
The purpose of the QASP is to describe the systematic methods used to monitor performance and identify required documentation and resources to be employed. The QASP provides a means for evaluating whether the contractor is meeting the performance standards/quality levels identified in the PWS and the contractor’s quality control plan (QCP), and ensure the government pays only for the level of services received.
This QASP defines the roles and responsibilities of all members of the integrated project team (IPT), identifies the performance objectives, defines the methodologies used to monitor and evaluate the contractor’s performance, describes quality assurance documentation requirements, and describes the analysis of quality assurance monitoring results.
3.0 Performance Management Approach
The PWS structures the acquisition around what service or quality level is required, as opposed to how the contractor should perform the work (i.e., results, not compliance). This QASP will define the performance management approach taken by SMART to monitor and manage the contractor’s performance to ensure the expected outcomes or performance objectives communicated in the PWS are achieved. Performance management rests on developing a capability to review and analyze information generated through performance assessment. The ability to make decisions based on the analysis of performance data is the cornerstone of performance management; this analysis yields information that indicates whether expected outcomes for the project are being achieved by the contractor.
Performance management represents a significant shift from the more traditional quality assurance (QA) concepts in several ways. Performance management focuses on assessing whether outcomes are being achieved and to what extent. This approach migrates away from scrutiny of compliance with the processes and practices used to achieve the outcome. A performance-based approach enables the contractor to play a large role in how the work is performed, if the proposed processes are within the stated constraints. The only exceptions to process reviews are those required by law (federal, state, and local) and compelling business situations, such as safety and health. A “results” focus provides the contractor flexibility to continuously improve and innovate over the course of the contract if the critical outcomes expected are being achieved and/or the desired performance levels are being met.
4.0 Performance Management Strategy
The contractor is responsible for the quality of all work performed. The contractor measures that quality through the contractor’s quality control (QC) program. QC is work output, not workers, and therefore includes all work performed under this contract regardless of whether the work is performed by contractor employees or subcontractors. The contractor’s QCP will set forth the staffing and procedures for self-inspecting the quality, timeliness, responsiveness, customer satisfaction, and other performance requirements in the PWS. The contractor will develop and implement a performance management system with processes to assess and report its performance to the designated government representative. The contractor’s QCP will also set forth the staffing and procedures for self-inspecting the quality, timeliness, responsiveness, customer satisfaction, and other performance requirements in the PWS. This QASP enables the government to take advantage of the contractor’s QC program.
The government representative(s) will monitor performance and review performance reports furnished by the contractor to determine how the contractor is performing against communicated performance objectives. The government will make determinations regarding incentives based on performance measurement metric data and notify the contractor of those decisions. The contractor will be responsible for making required changes in processes and practices to ensure performance is managed effectively.
5.0 ROLES AND RESPONSIBILITIES
The Contracting Officer (CO/KO) The CO is responsible for monitoring contract compliance, contract administration, and cost control, and resolving any differences between observations documented by the contracting officer's representative (COR) and/or the SMART program manager (SMART PM) and the contractor. The CO will designate one full-time COR as the government authority for performance management. The number of additional representatives serving as technical inspectors depends on the complexity of the services measured, as well as the contractor’s performance, and must be identified and designated by the CO.
The COR The COR is designated in writing by the CO to act as their authorized representative to assist in administering a contract. COR limitations are contained in the written appointment letter. The COR is responsible for technical administration of the project and ensures proper government surveillance of the contractor’s performance. The COR is not empowered to make any contractual commitments or authorize any contractual changes on the government’s behalf. Any changes the contractor deems may affect contract price, terms, or conditions must be referred to the CO for action. The COR will have the responsibility for completing QA monitoring forms used to document the inspection and evaluation of the contractor’s work performance. Government surveillance may occur under the inspection of services clause for any service relating to the contract.
6.0 IDENTIFICATION OF REQUIRED PERFORMANCE STANDARDS/QUALITY LEVELS
The required performance standards and/or quality levels are included in the PWS and Attachment 1, Performance Requirements Summary.
7.0 METHODOLOGIES TO MONITOR PERFORMANCE
Surveillance Techniques To minimize the performance management burden, simplified surveillance methods shall be used by the government to evaluate contractor performance when appropriate. The primary method of surveillance is direct observation of task performance from the performance standards.
8.0 Customer Feedback
The contractor is expected to establish and maintain professional communication between its employees and customers. The primary objective of this communication is customer satisfaction. Customer satisfaction is the most significant external indicator of the success and effectiveness of all services provided and can be measured through customer complaints.
Performance management drives the contractor to be customer focused through initially and internally addressing customer complaints and investigating the issues and/or problems, but the customer always has the option to communicate complaints to the CO or COR, as opposed to the contractor.
Customer complaints, to be considered valid, must set forth clearly and in writing the detailed nature of the complaint, must be signed, and must be forwarded to the COR. The COR will accept those customer complaints and investigate.
Customer feedback may also be obtained either from the results of formal customer satisfaction surveys or from random customer complaints.
9.0 Acceptable Quality Levels
The acceptable quality levels (AQLs) included in Attachment 1 for contractor performance are structured to allow the contractor to manage how the work is performed while providing negative incentives for performance shortfalls. For certain critical activities, such as those involving providing feedback on Serious or Non-conformance issues discovered during visits, completion of training, and travel, the desired performance level is established at 100 percent. Other levels of performance are keyed to the relative importance of the task to the overall mission performance of SMART.
10.0 QUALITY ASSURANCE DOCUMENTATION
The Performance Management Feedback Loop The performance management feedback loop begins with the communication of expected outcomes. Performance standards are expressed in the PWS and assessed using the performance monitoring techniques shown in Attachment 1.
Monitoring Forms The government’s QA surveillance, accomplished by the COR, or SMART PM, will be reported using the monitoring form in Attachment 2. The forms, when completed, will document the government’s assessment of the contractor’s performance under the contract to ensure the required service and quality levels are being achieved.
The SMART PM will retain a copy of all completed QA surveillance forms.
11.0 ANALYSIS OF QUALITY ASSURANCE ASSESSMENT
Determining Performance The government shall use the monitoring methods cited to determine whether the performance standards/service levels/AQLs have been met. If the contractor has not met the minimum requirements, it may be asked to develop a corrective action plan to show how and by what date it intends to bring performance up to the required levels.
Reporting At the end of every quarter, the SMART Program Manager will prepare a written report for the Contracting Officer Representative summarizing the overall results of the quality assurance surveillance of the contractor’s performance. This report, which includes the contractor’s submitted monthly report and the completed quality assurance monitoring forms (Attachment 2), will become part of the QA documentation. It will enable the government to demonstrate whether the contractor is meeting the stated objectives and/or performance standards, including cost/technical/scheduling objectives.
Reviews and Resolution The COR or SMART PM may require the contractor’s project manager or designated alternate to meet with the CO, ACO, COR, SMART PM or SMART Director and other government IPT personnel as deemed necessary to discuss the performance evaluation. The SMART PM may define a frequency of in-depth reviews with the contractor, including appropriate self-assessments by the contractor; however, if the need arises, the contractor will meet with the COR or SMART PM as often as required or per the contractor’s request. The agenda of the reviews may include:
Monthly performance assessment data and trend analysis Issues and concerns of both parties Projected outlook for upcoming months and progress against expected trends, including a corrective action plan analysis Recommendations for improved efficiency and/or effectiveness Issues arising from the performance monitoring processes
The COR or SMART PM must coordinate and communicate with the contractor to resolve issues and concerns regarding marginal or unacceptable performance.
The COR or SMART PM and contractor should jointly formulate tactical and long-term courses of action. Decisions regarding changes to metrics, thresholds, or service levels should be clearly documented. Changes to service levels, procedures, and metrics will be incorporated as a contract modification at the convenience of the procuring CO (PCO) or ACO.
ATTACHMENT 1: PERFORMANCE REQUIREMENTS SUMMARY
| Task |
| PWS Reference |
| Performance Standard |
| Acceptable Quality Level |
| Method of Surveillance |
| Incentive |
Task 1 – CRQA visits with pre and post work, (INCLUDES PORTAL-TO-PORTALTRAVEL TIME) [CLIN 1 & 2]
| Subtasks 1a, 1b,1c 1d-(*note sub-bullet AQL below) |
| Visits conducted within the designated times |
Meets standard 95% of the time
What: Visit schedule, communication, and completion How: Management Information System (MIS) comprised of various performance tracking reports Frequency: Each visit Who: SMART Program Manager and/or COR
Positive Performance Rating
Task 1 – CRQA visits with pre and post work, (INCLUDES PORTAL-TO-PORTALTRAVEL TIME) [CLIN 1 & 2]
| *Subtask 1d – sub bullet |
| Provide CSP Director and SMART Staff Leadership immediate feedback of significant discoveries made during site visits, example- |
Contractor shall recognize and communicate and promptly report Serious or continuing Non-conformance per ORO/VHA criteria.
| Meets standard at least 100% of the time. |
| What: Reporting of Serious or continuing Non-conformance when Conducting site visits |
How: Management Information System (MIS) comprised of various performance tracking reports Frequency: Each visit Who: SMART Program Manager and/or COR
Positive Performance Rating
Task 1 – CRQA visits with pre and post work, (INCLUDES PORTAL-TO-PORTALTRAVEL TIME) [CLIN 1 & 2]
| Subtask 1e, 1f |
| Within seven business days (or current SOP requirement) of last day on site of site visit, the contractor shall complete a site visit report, Summary for Investigator and applicable attachments |
Documents will be reviewed by a CSP study Lead to ensure CSP quality standards are met and returned to the contractor for minor revision no more than once per submission.
Contractor shall respond to the leads calls and questions/queries in a timely manner (within a 24-hour period or timeline requested).
| Meets standard 95% of the time |
| What: Visit Site Visit reports, investigator summaries and applicable attachments required revisions (pre, during and post visit communication) |
How: Email and telephone communication Frequency: Each visit Who: SMART Lead, Program Manager and/or COR
Positive Performance Rating
Task 2 – CRQA Visits without pre and post work (INCLUDES PORTAL-TO-PORTAL TRAVEL TIME) [CLIN 1 & 2]
| Subtask 2a, 2b |
| Provides support to CRQAs, meeting and training attendance if requested. |
| Meets standard 95% of the time |
| What: Support CRQA support and meeting attendance, training as requested |
How: Management Information System (MIS) comprised of various performance tracking reports Frequency: As needed Who: SMART Program Manager and/or COR Positive Performance Rating
| Task 3 - GCP Quality Assurance (QA) support to the VA Cooperative Studies Program, Hourly; no travel required [CLIN 3] |
| Subtask 3a-3g |
| Hourly services conducted within the designated times |
Meets standard 95% of the time
What: Provides GCP QAS hourly support as requested How: Feedback from requestor Frequency: As needed Who: SMART Program Manager and/or COR
Positive Performance Rating
| Task 3 - GCP Quality Assurance (QA) support to the VA Cooperative Studies Program, Hourly; no travel required [CLIN 3] |
| Subtask 3h |
| The SDR shall finalize and approve reports prior to distribution. |
Meets standard 95% of the time
What: Provides GCP QAS hourly support as requested How: Feedback from requestor Frequency: As needed Who: SMART Program Manager and/or COR
Positive Performance Rating
| The Contractor shall complete mandatory VHA training (Privacy, HIPAA, Ethics, Information Security, GCP, and others as assigned. |
| 18 |
| Training completed on time and currency maintained. |
ZERO overdue training prior to performing scheduled contract tasks (i.e. scheduled visit) Meets standard 100% of time
What: Training records and reports.
How: Verify status in the VA Talent Management System (TMS) Frequency: When required Who: SMART Program Manager and/or COR Positive Performance Rating
Services (Travel arrangements and Reimbursement)
| 3 |
| The Contractor shall schedule, book, and select and provide documentation of travel modes, airfare, hotels, rental cars and other travel related expense at the lowest cost to government and submit travel documentation for purposes of receiving payment. Non-conformance will result in a rejected invoice requiring resubmittal. |
| Meets standard 100% of the time unless mitigating circumstances, such as weather or emergency disaster. Communication with COR, SMART Leadership required. |
| What: Travel scheduling, arrangements and documentation |
How: Compare submitted documents to SMART provided Travel Documentation Checklist Frequency: Each visit, Once submitted Who: SMART Program Manager and/or COR
Positive Performance Rating
| Invoicing |
| 19 |
| Within 30 days of visit or QAS And after all QA services are complete and all associated QA documents are submitted. |
Contractor (PRIME if there are Subcontractors) shall review and submit any subcontractor invoices and travel reimbursement documents.
Meets standard 90% of the time.
What: Travel documentation, Invoices How: Compare submitted documents to SMART provided Travel Documentation Checklist Frequency: Once submitted Who: SMART Program Manager and/or COR
Positive Performance Rating
ATTACHMENT 2: SAMPLE QUALITY ASSURANCE MONITORING FORM
SERVICE or STANDARD:
SURVEY PERIOD:
SURVEILLANCE METHOD (check):
Random Sampling 100% Inspection Periodic Inspection Customer Complaint LEVEL OF SURVEILLANCE (check):
| Monthly | Quarterly | As needed | |
| PERCENTAGE OF ITEMS SAMPLED DURING SURVEY PERIOD: | ______ % |
ANALYSIS OF RESULTS:
Observed Service Provider Performance Measurement Rate: ______%
| Service Provider’s Performance (check): | Meets Standards |
| Does Not Meet Standards |
Narrative of Performance During Survey Period:
PREPARED BY: ___________________________________ DATE: _________________
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