Attachment 1e-Task Order 1 QASP.pdf
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- Solicitation number
- 75R60226R00026
About this file
This document is a Quality Assurance Surveillance Plan (QASP) for Task Order 1 under MCHB IDIQ Solicitation #75R60226R00026, establishing performance objectives and acceptable quality levels for evidence reviews of newborn screening genetic conditions.
The QASP delineates eight primary task areas with specific performance standards and surveillance methods. Task 1 requires 100% completion of federal records management training within 30 days of contract award or new staff onboarding. Task 2 mandates program management activities including a kickoff meeting within 2 weeks of award with 100% compliance on all deadlines, and monthly meetings with 95% on-time deliverable submission and 100% reporting accuracy. Task 3 addresses clinical evidence review for biliary atresia, requiring 100% COR-approved expert panel members prior to review initiation, draft reports within 4 months of EDOC and final reports within 5 months with 95% feedback incorporation, and consumer-friendly summaries at 8th-grade reading level delivered within 14 days of receiving comments. Task 4 requires development of a Manual of Procedures and training materials with 100% on-schedule delivery meeting all content requirements. Task 5 mandates an evidence protocol submitted within 3 months of EDOC and evidence summary reports with final versions delivered within 2 weeks of feedback receipt incorporating 100% of feedback. Task 6 requires project timeline submission within 6 months of EDOC and draft reports within 10 months with final reports within 12 months, achieving 100% on-time delivery and 95% accurate feedback incorporation. Task 7 establishes information security incident reporting within 1 hour of discovery. Task 8 requires AI compliance and risk management plan approval before any AI use. General deliverables include 100% Section 508 accessibility compliance on all electronic and information technology deliverables, with rework of non-compliant items at contractor expense.
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Attachment 1e – Task Order 1 QASP Evidence Reviews of Newborn Screening Genetic Conditions
MCHB IDIQ Solicitation #75R60226R00026
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 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.
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)
MCHB IDIQ Solicitation #75R60226R00026
Performance Objective Performance Standard Method of Surveillance
Acceptable Quality Level
(AQL)
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.
Task 8: 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.
General Deliverables mailto:hrsacsirt@hrsa.gov
MCHB IDIQ Solicitation #75R60226R00026
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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