Attachment 1b- IDIQ QASP.pdf
PDF 196 KB Posted
- Solicitation number
- 75R60226R00026
About this file
This is a Quality Assurance Surveillance Plan (QASP) for the MCHB IDIQ Solicitation #75R60226R00026, which addresses Evidence Reviews and Newborn Screening Genetic Conditions. The QASP establishes the framework for HRSA to monitor contractor performance and ensure that public health evidence reviews are rigorous, objective, and timely. The plan identifies six key performance standards with corresponding metrics, acceptable quality levels, surveillance methods, and incentives or disincentives.
The performance standards include: (1) Deliverable Timeliness for Tasks 3, 4, 5, and 6, requiring ≥95% of draft and final deliverables submitted on time, monitored through inspection of the COR Deliverable Log, with positive past performance ratings as incentive or corrective action plans for non-compliance; (2) Deliverable Quality & Compliance, requiring 100% compliance with Section 508 (WCAG 2.0 AA) accessibility standards and 8th-grade reading level for consumer summaries, monitored through accessibility validation tools and readability index tests, with routine acceptance or deliverable rejection requiring contractor remediation at their own cost; (3) Security & Privacy Safeguards for Tasks 1 and 7, requiring 100% training compliance within 30 days, zero unvalidated devices, and breach reporting within 1 hour, monitored through periodic audits with continued authorization to operate as incentive or immediate stop-work orders and potential contract termination for non-compliance; (4) Integrity & Objectivity, requiring 100% Conflict of Interest screenings and signed NDAs for all personnel and subject matter experts prior to substantive work, monitored through inspection of onboarding packages; (5) Program Management & Tracking, requiring weekly updates to a centralized PM information system with current task statuses, risks, and milestones, monitored through periodic oversight and random sampling during monthly meetings. Surveillance execution methods include 100% inspection of all core scientific reports, frameworks, manuals of procedures, and consumer summaries; periodic audits by the COR on security logs and training certificates; and stakeholder feedback review from the National Newborn Screening Stakeholder Workgroup during draft report review periods.
View the file
Other files
Show all 20
On GovTribe
Work with this file
- Download the original file
- Contacts named in this file
- Similar government files
- Ask GovTribe AI about this file
Text version
Attachment 1b-MASTER IDIQ QASP Evidence Reviews and Newborn Screening Genetic Conditions
Quality Assurance Surveillance Plan (QASP)
MCHB IDIQ Solicitation #75R60226R00026
This QASP provides the framework by which HRSA will monitor contractor performance to ensure public health evidence reviews are rigorous, objective, and timely.
Performance Standard (SOW Ref)
Performance Indicator (Metric)
Acceptable Quality Level (AQL) Surveillance Method Incentive / Disincentive
Deliverable Timeliness (Tasks 3, 4, 5, 6)
Adherence to scheduled deadlines in the SOW/approved timelines.
≥ 95% of draft and final deliverables submitted on time per agreed schedules.
100% Inspection of the COR Deliverable Log.
Met: Positive Past Performance rating.
Unmet: Documented in CPARS; requirement for a Corrective Action Plan
(CAP).
Deliverable Quality & Compliance (Section 508 & Reading Level)
Consumer summaries at the correct reading level; all digital content must pass accessibility checkers.
100% compliance with Section 508 (WCAG 2.0 AA) and 8th-grade reading level for consumer summaries.
100% Inspection using accessibility validation tools and readability index tests.
Met: Routine acceptance.
Unmet: Deliverable rejected; contractor must remediate at their own cost.
Security & Privacy Safeguards (Task 1 & Task 7)
Training compliance;
immediate breach notification; FIPS 140 validated encryption implementation.
100% compliance.
Training within 30 days; zero unvalidated devices;
breaches reported within 1 hour.
Periodic audits of training logs, encryption inventories, and incident logs.
Met: Continued authorization to operate.
Unmet: Immediate stop-work order, potential contract termination, and legal liability.
Integrity & Objectivity (Task 3.2, 3.3, 6.3, 6.4)
Completion of Conflict of Interest (COI) screenings and NDAs for all personnel and panel experts.
100% of personnel and SMEs screened and NDAs signed prior to substantive review work.
100% Inspection of onboarding packages and signed clearance logs.
Met: Maintained trust and panel integrity.
Unmet: Disqualification of panel findings; rework required at contractor expense.
Program Management & Tracking (Task 2.2)
Maintaining and utilizing the centralized PM information system for real-time tracking.
System must be actively updated weekly with current task statuses, risks, and milestones.
Periodic oversight / random sampling of the PM system during monthly meetings.
Met: Satisfactory management rating.
Unmet: Cure notice or formal contract warning.
Surveillance Execution Methods
1. 100% Inspection: Applied to all core scientific reports, frameworks, manuals of procedures
(MOP), and consumer summaries to ensure clinical accuracy and adherence to strict structural constraints (e.g., 12-page limit for consumer reports).
Attachment 1b-MASTER IDIQ QASP Evidence Reviews and Newborn Screening Genetic Conditions
Quality Assurance Surveillance Plan (QASP)
MCHB IDIQ Solicitation #75R60226R00026
2. Periodic Audits: Conducted by the COR on security logs, training certificates, and project tracking system updates to confirm administrative compliance.
3. Stakeholder Feedback Review: Input from the National Newborn Screening Stakeholder
Workgroup and public commentary will be monitored during the draft report review periods to measure the quality and completeness of the contractor's analysis.
File details come from the government source that posted it. Updated .