Attachment 1e-TO 1 QASP-A1.pdf
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- Solicitation number
- 75R60226R00026
About this file
This is a Quality Assurance Surveillance Plan (QASP) for Task Order 1 under MCHB IDIQ Solicitation #75R60226R00026-A1, focusing on Evidence Reviews of Newborn Screening Genetic Conditions. The QASP establishes performance objectives, standards, monitoring methods, and acceptable quality levels (AQLs) for all deliverables and tasks.
The task order encompasses seven major task areas with specific performance requirements. Task 1 requires 100% of staff to complete Federal Records Management Training within 30 days of contract award or new staff onboarding. Task 2 establishes program management requirements including a kickoff meeting within 2 weeks of award with 100% compliance on deadlines, monthly meetings with 95% on-time submission of agendas and notes with 100% accuracy, and an AI Compliance requirement mandating 100% COR/CO approval of any AI use disclosure and risk management plan before implementation. Task 3 covers clinical evidence review for Biliary Atresia, requiring 100% COR approval of expert panel members before review initiation, with draft reports due within 4 months of EDOC and final reports within 5 months with 95% feedback incorporation. Task 4 requires development of a Manual of Procedures with 100% on-schedule delivery of all content-compliant deliverables. Task 5 establishes evidence scans for newborn screening conditions with protocols due within 3 months of EDOC and final summary reports within 2 weeks of feedback receipt. Task 6 requires evidence-based reviews for RUSP with project timelines due within 6 months of EDOC, draft reports within 10 months, and final reports within 12 months with 95% feedback incorporation. Task 7 mandates 100% incident reporting for information security breaches within 1 hour of discovery. All electronic deliverables must achieve 100% Section 508 accessibility compliance, with contractor-funded rework required for non-compliant items.
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Attachment 1e – Task Order 1 QASP-A1 Evidence Reviews of Newborn Screening Genetic Conditions
MCHB IDIQ Solicitation #75R60226R00026-A1 The following table outlines the performance objectives derived from the SOW, the standards of performance, how performance will be monitored, and the acceptable quality level for each.
Performance Objective Performance Standard Method of Surveillance
Acceptable Quality Level
(AQL)
Task 1: Federal Records Management
1.3 Complete Records
Management Training
All staff complete required training and submit certificates.
COR review of submitted completion certificates/listing.
100% of staff certificates submitted to the COR within 30 days of contract award or new staff onboarding.
Task 2: Program Management
2.1 Hold Kickoff Meeting Agenda submitted on time;
meeting held within 2 weeks of award; minutes and revised timeline submitted on time.
Direct observation by COR and review of deliverables (agenda, minutes, timeline).
100% compliance with all deadlines and requirements.
2.2 Conduct Monthly
Meetings & Reporting
Agendas, meeting notes, and summaries are submitted accurately and on schedule.
Project management system is kept current.
COR review of submitted documents (agendas, notes) and periodic checks of the project management system.
95% of monthly deliverables submitted on time. 100% accuracy in reporting.
Task 2.3: AI Compliance
AI Use Disclosure & Plan Submission
AI compliance and risk management plan must be submitted and approved by the CO before any AI use.
COR/CO review and written approval of the plan.
Plan approved before any use of AI. 100% adherence to the approved plan.
Task 3: Clinical Evidence Review for Biliary Atresia
3.2-3.3 Convene Expert Panels
A qualified team of experts is approved by the COR and convened. All NDAs are signed.
COR review and approval of the proposed expert list and review of signed NDAs.
100% of panel members approved by COR prior to review initiation.
3.4 Develop Clinical
Evidence Review Report
Draft and final reports are delivered on time, are comprehensive, and incorporate all required feedback.
COR review and acceptance of draft and final reports.
Draft submitted within 4 months of EDOC. Final report submitted within 5 months of EDOC. 95% of feedback incorporated correctly.
MCHB IDIQ Solicitation #75R60226R00026-A1 Performance Objective Performance Standard Method of
Surveillance Acceptable Quality Level
(AQL)
3.5 Develop Consumer-
Friendly Summary
Draft and final summaries are delivered on time, meet the 8th-grade reading level, are within the page limit, and incorporate COR feedback.
COR review of draft and final summaries for readability, content accuracy, and adherence to requirements.
Final summary delivered within 14 days of receiving comments with 100% of COR edits incorporated.
Task 4: Develop Manual of Procedures (MOP)
4.1-4.4 Draft and Finalize MOP & Training Materials
Environmental scan, draft MOP, final MOP, and training materials are delivered by the deadlines and meet all specified requirements.
COR review and approval of all submitted documents and materials.
100% of deliverables submitted on schedule and meeting all content requirements outlined in the SOW.
Task 5: Evidence Scans for Newborn Screening Conditions
5.1 Develop Evidence
Protocol
Protocol is comprehensive and submitted for COR approval on time.
COR review and formal approval of the evidence protocol.
Protocol submitted within 3 months of EDOC.
5.3-5.4 Submit Evidence Summary Reports
Draft and final reports are delivered on schedule, are accurate, and incorporate all feedback.
COR review and acceptance of draft and final summary reports.
Final reports submitted within 2 weeks of receiving feedback, with 100% of feedback incorporated.
Task 6: Conduct Evidence-Based Reviews for RUSP
6.2 Deliver Project
Timeline
A comprehensive timeline for concurrent reviews is submitted for COR approval on schedule.
COR review and formal approval of the project timeline.
Timeline submitted for approval within 6 months of
EDOC.
6.5-6.6 Deliver Draft and Final Reports
Draft reports delivered within 10 months; final reports incorporating all feedback delivered within 12 months.
COR review and acceptance of draft and final reports.
100% on-time delivery. 95% of feedback accurately incorporated into final reports.
Task 7: Information Security
Incident Reporting Report all security incidents within the specified timeframe.
Direct notification to COR and hrsacsirt@hrsa.gov.
100% of incidents reported within 1 hour of discovery.
General Deliverables mailto:hrsacsirt@hrsa.gov
MCHB IDIQ Solicitation #75R60226R00026-A1 Performance Objective Performance Standard Method of
Surveillance Acceptable Quality Level
(AQL)
Section 508 Compliance All electronic and information technology deliverables are fully compliant with Section 508 accessibility standards.
Review of deliverables using HHS Section 508 Accessibility Compliance Checklists.
100% compliance on all final deliverables. Rework of non-compliant items required at contractor expense.
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