SOO Attachment 0001 OTADRLs_08 Mar 2021.pdf

SOO_Attachment 0001: Other Transaction Agreements Data Requirements List (OTADRLs)

OTADRL# Deliverable Deliverable Description Reporting Procedures and Due Dates

01 Meetings

01.1 Post Award

Kickoff Meeting

The contractor shall complete an initial kickoff meeting after OTA award.

Meeting will cover the following topics:

1. Outline activities for the next 30 days

2. Draft Integrated Master Schedule

(IMS) for the entirety of the PoP.

3. Organizational chart with telephone numbers and email addresses of leadership at coordination centers, and locations of laboratories.

4. Plan on how coordination centers will engage local and state organizations to establish testing agreements.

• Within 3 days of OTA award

• Contractor shall provide agenda, establish a teleconference number, a Draft IMS, and a local and state engagement plan at least 1 business day in advance of the kickoff meeting with the Testing and Diagnostics Working Group (TDWG).

• AOR edits/approves and instructs contractor to distribute agenda prior to meeting

• Contractor provides meeting minutes to AOR within 3 business days after the meeting

• AOR reviews, comments and approves minutes within 5 business days

01.2 Daily check in with

TDWG

Upon request of the Government, the Contractor shall participate in a daily check-in update with the project staff (via teleconference or email).

The updates will address key cost, schedule and technical updates. Daily updates may be shared with senior Government leaders during period of performance and should be provided on a non-confidential basis, unless the update includes confidential information in which case Contractor shall provide the update in both confidential and non-confidential formats.

Daily check-ins may occur on weekdays, excluding federal holidays. Upon request of the Government, check-ins may also occur on weekends and on federal holidays, provided at least 24 hours’ notice.

• No agenda will be required for the meeting

• No meeting minutes are required

• Contractor will provide bulleted email updates to

AOR following any call or in lieu of a call by 1600 EST for that day

• AOR is the primary point of contact for daily check-ins

01.3 Weekly

Teleconference

The Contractor shall participate in weekly teleconferences with TDWG to discuss the progress on the performance of the OTA. Meeting frequency can be increased as needed during the course of the project

• Contractor provides agenda to AOR no later than 2 business days in advance of meeting

• AOR edits/approves and instructs contractor to distribute agenda prior to meeting

• Contractor distributes agenda and presentation materials at least 24 hours in advance

• Contractor provides meeting minutes to AOR within 2 business days of the meeting

• AOR reviews, comments, and approves minutes within 1 business days

01.4 FDA and CMS

Meetings The Contractor shall forward to the TDWG the dates and times of any meeting with the FDA, CMS, or any other federal agency involving either the Contractor or any Laboratories related to performance of this Agreement and make arrangements for appropriate TDWG staff to attend the meetings. TDWG staff shall include up to a maximum of four people (typically AOR and up to 3 subject matter experts). The Contractor shall ensure this requirement flows down to all contractual arrangements with Laboratories.

• Contractor shall notify the TDWG of upcoming meeting with FDA, CMS or any other federal agency within 24 hours of scheduling meetings OR within 24 hours of meeting occurrence for ad hoc meetings

• The Contractor shall forward initial Contractor and agency-issued draft minutes and final minutes of any meeting to the TDWG within 2 business days of receipt

02 Technical Reporting

02.1 Submit Weekly Testing

Data Report to the

TDWG

Coordination centers shall report a roll-up of COVID-19 aggregate data to the TDWG weekly or more frequently as required by the USG. Data shall include, but is not limited to:

• Total schools in region

• How many students and teachers/staff within available schools

• How many students tested

• How many teachers/staff tested

• How many other community members tested

• Positive / Negative / Inconclusive tests

• % in-person learning

• Symptom status

• Vaccine status

• Demographics

• Turnaround Time metrics

• Aggregated by state / lab / hub

• Test type

Coordinating centers will be expected to continuously optimize data reporting to the TDWG team as needed. This optimization will include the continuous improving and uniformity of testing data reports.

Reports will not contain PHI or PII data.

• The report data will cover all tests administered during the previous week (Friday-Thursday) and all test results returned during the previous week.

• Data is due NLT Friday at 1200 EST to the

AOR.

• AOR edits, reviews, and approves contractor reports. Once approved, the AOR will combine all coordination center data into one report and disseminates throughout the Government.

• Contractors should attempt to present data via a standardized report/dashboard to facilitate ease of presenting data.

• Contractors are expected to work in coordination with the TDWG Program Management team to ensure efficiency and standardization of data reporting.

02.2 Report Diagnostics

Data to State, Local, and School Districts

Report COVID-19 results within 48 hours of sample collection, IAW state and local regulations and the terms of the OTA with the USG.

• Instances of non-compliance shall be handled in accordance with OTADRL 2.3 below.

02.3 Local, State, and

Federal Reporting

Requirements Issues

Contractors shall report within 2 hours instances of non-compliance with local, state, and federal testing requirements to the AOR.

• Instances of non-compliance will be reported via an immediate phone call to the AOR, followed up with an email stating the nature of the violation, the date, time group (DTG) of the violation, plan to resolve, and anticipated resolution date.

• AOR edits, reviews, and approves the contractor report. Once approved, the AOR will disseminate the violation to the TDWG leadership.

02.4

Monthly Technical Progress Reports

Meeting

The Monthly Technical Progress reports shall address each of the below items and be cross-referenced to the Statement of Objectives (SOO), Integrated Master Schedule (IMS), and Contract Performance Report (CPR) – or as applicable

1. An Executive Summary highlighting the progress, issues and relevant regulatory activities. The Executive Summary should highlight only critical issues for that reporting period and resolution approach; limited to 2 pages.

2. Progress in meeting OTA milestones, overall project assessment, problems encountered and recommended solutions. The reports shall detail the planned and actual progress during the period covered, explaining any differences between the two and the corrective steps

3. A three-month rolling forecast of the key planned activities, referencing the

IMS

4. Estimated and Actual Expenses:

a. This report shall also contain a narrative or table detailing whether there is a significant discrepancy (>10%) at

• Monthly Reports shall be submitted on the 20th day of the month covering the preceding month

• Contractor shall provide FINAL versions of reports within 10 business days after receiving TDWG comments/edits this time between the % of work completed and the cumulative costs incurred to date. Monthly and actual expenses should be broken down to the appropriate level. This section of the report should also contain estimates for the Subcontractors’ expenses from the previous month if the Subcontractor did not submit a bill in the previous month.

If the subcontractor(s) was not working or did not incur any costs in the previous month, then a statement to this effect should be included in this report for those respective subcontractors If the AOR and AO are satisfied that the contractor’s reporting is sufficient to convey this information, this section may be waived.

02.5 (Draft)

Draft and Final Technical Progress

Report

A draft Final Technical Progress Report containing a summation of the work performed and the results obtained over the entire PoP. This report shall be in sufficient detail to fully describe the progress achieved under all milestones and the results achieved. Report should contain a timeline of originally planned and baselined activities and milestones overlaid with actual progress attained during the PoP. Descriptions and rationale for activities and milestones that were not completed as planned should be provided. The draft report shall be duly marked as ’Draft’

• The Draft Technical Progress Report shall be submitted 20 calendar days before the end of the PoP and the Final Technical Progress Report on or before the completion date of the PoP

• AOR will provide feedback on draft report within 10 calendar days of receipt, which the Contractor shall consider incorporating into the Final Report

02.5 (Final)

Draft and Final Technical Progress

Report

The Final Technical Progress Report incorporating feedback received from TDWG and containing a summation of the work performed and the results obtained for the entire OTA PoP. The final report shall document the results of the entire OTA. The final report shall be duly marked as ’Final’. A cover letter with the report will contain a summary (not to exceed 200 words) of salient results achieved during the performance of the OTA.

Both reports shall conform to the following format:

1. Cover page to include the OTA number, OTA title, performance period covered, Contractor’s name and address, telephone number, fax number, email address and submission date.

2. Executive Summary: Summarize the purpose and scope of the OTA effort

The Final Technical Progress Report is due to the AOR on the last day of the OTA PoP.

including a summary of the major accomplishments relative to the specific activities set forth in the

SOO.

3. Results: A detailed description of work performed, the results obtained, and the impact of the results on the K-8 community.

4. Lesson’s Learned: Document the successes and failures of establishing, operating, and closing-out a COVID-19 testing coordination center. Discuss engagement and establishment of agreements with local and state organizations, testing procedures, reporting, improves/sustains to relationship with the TDWG, and suggested changes to OTA documents.

02.6 Contractor Locations The contractor shall submit detailed data regarding locations where work will be performed under this OTA, including addresses, points of contact, and work performed per location, to include sub-contractors.

Contractor will submit Work Locations Report:

• Within 5 business days of OTA award

• Within 2 business days after a substantive location or capabilities change Contractor will submit an updated Work Locations Report via email to the AOR IAW timeline in the bullets above.

02.7 Pandemic

Management Plan

A pandemic facility and/or operational management plan including change procedures from normal to pandemic operations Contractor will prepare an operational plan to continue operations in the event of a declared pandemic emergency.

Contractor will submit Pandemic Management Plan:

• Draft within 15 days of award

• Final within 30 days of award

02.8 Final Data Submission

Package

Contractor must submit a data package consisting of all raw data (see OTADRL 2.1) produced under this OTA. Data may be used by TDWG for analysis, evaluation, shared with other agencies, or shared outside of the government consistent with FAR 52.227-14. This submission package must be delivered in a non-proprietary format.

If clinical trial data is included, that data must be provided consistent with applicable privacy laws to protect personally identifiable information (PII).

• Contractor will submit the Final Data Submission Package at least 10 days prior to OTA end date.

Partial data sets may also be requested for delivery prior to submission of the Final Data Submission Package.

• The AOR will receive, review, and provide feedback on the Final Data Submission Package prior to the end of OTA PoP.

02.9 Supplemental

Technical

Documents, Raw Data, Tabulation Data

(e.g., CDISC-compliant SDTM SAS

XPT datasets), or Data Analysis (e.g., CDISC-compliant ADaM SAS XPT datasets)

Upon request and also as part of deliverables the Contractor shall provide:

raw data, Tabulation Data (e.g., CDISC-compliant SDTM SAS XPT datasets), or Data Analysis (e.g., CDISC-compliant ADaM SAS XPT datasets), or data report to

TDWG.

Contractor shall provide the Technical Documents upon request from the AO or AOR within 24 hours.

02.10 Quality Management

Plan

Contractor shall prepare a plan that addresses comprehensive quality management for all Laboratories that will provide test services for Contractor, clearly delineating the responsibilities among Contractor and Laboratories. Plan may include, but is not limited to the quality policy and objectives, management review, competencies and training, process document control, feedback, evaluation, corrective action and preventive action, process improvement, measurement, and data analysis processes. The framework is normally divided into infrastructure, senior management responsibility, resource management, lifecycle management, and quality management system evaluation.

Plan will be delivered electronically within 10 days of OTA award to the AO and AOR

02.11 Quality Agreement Agreement will determine the conditions of acceptance by the USG of the purchased.

Contractor shall ensure appropriate Quality Agreements are in place to cover all Laboratories participating in performance of this Agreement, sufficient to ensure all testing performed for this Agreement meets the condition of acceptance by the USG.

• Quality Agreement will be signed by the USG and the manufacturer within 30 days of OTA award executed on or before the date when the covered Laboratory begins performance under this Agreement

• Agreement will be delivered electronically to USG within 2 days of execution

02.12 Legal/Regulatory

Compliance Plan

Contractor shall prepare a plan that ensures all local, state, and federal laws and regulations relevant to the performance of the OTA by the Contractor and each Laboratory are considered to ensure and enable personnel and each Laboratory to perform their respective obligations under the OTA in accordance with those relevant laws and regulations.

Plan will be delivered electronically within 10 days of OTA award to the AO and AOR.

02.13 Local and State

Engagement /

Agreement Plan

Contractor shall provide their plan to engage local and state entities in establishing agreements to conduct COVID-19 testing within their assigned region. Plan will cover which agencies and organizations the Contractor will contact, their timeline to establish testing agreements, and practical issues necessary to start testing students, including informed consent/waivers that comply with state and federal law.

• Contactors will provide their final local and state engagement / agreement plan to the AOR within 10 days of award (reference draft plan in OTADRL 01.1 – Post Award Kickoff Meeting).

• AOR and AO will review and provide feedback within 10 business from receipt of the engagement / agreement plan.

• Contractor will report deviations or issues with plan to AOR with 48 hours of changes / issues.

03 Audits

03.1 TDWG Audit Contractor shall accommodate periodic or

ad hoc site visits by TDWG. If TDWG, the Contractor, or other parties identifies any issues during an audit, the Contractor shall capture the issues, identify potential solutions, and provide a report to TDWG

• If issues are identified during the audit, Contractor shall submit a report to TDWG detailing the finding and corrective action(s) within 10 business days of the audit

• AOR and AO will review the report and provide a response to the Contractor with 10 business days

• Once corrective action is completed, the Contractor will provide a final report to TDWG

03.2 FDA/CMS Audits and

Inspections

In the event of an FDA or CMS inspection that occurs in relation to this OTA, or for any other FDA or CMS inspection that has the reasonable potential to impact the performance of this OTA, the Contractor shall provide the USG with an exact copy (non-redacted) of the FDA Form 483 and the Establishment Inspection Report (EIR), or CLIA related Letters including State Agency (SA) Letters and Regional Office (RO) Letters. The Contractor shall provide the AOR and CO with copies of the plan for addressing areas of non- conformance to FDA and CMS regulations as identified in the audit report, status updates during the plans execution and a copy of all final responses to the FDA or CMS. The Contractor shall also provide redacted copies of any FDA and CMS audits received from subcontractors that occur as

• Contractor shall notify AO and AOR within 10 business days of a scheduled FDA or CMS audit or within 24 hours of an ad hoc site visit/audit if the FDA does not provide advanced notice

• Contractor shall provide copies of any FDA or CMS audit report received from subcontractors that occur as a result of this OTA or for this product within 1 business day of receiving correspondence from the FDA, CMS, or third party

• Within 10 business days of audit report, Contractor shall provide AO with a plan for addressing areas of nonconformance, if any are identified a result of this OTA or for this product. The Contractor shall make arrangements for TDWG representative(s) to be present during the final debrief by the regulatory inspector. The Contractor shall ensure this requirement flows down to all contractual arrangements with Laboratories.

03.3 QA Audits TDWG reserves the right to participate in

QA audits performed by the contractor.

Upon completion of the audit/site visit the Contractor shall provide a report capturing the findings, results and next steps in proceeding with the subcontractor. If action is requested of the subcontractor, detailed concerns for addressing areas of non-conformance to FDA and CMS regulations and guidelines, as identified in the audit report, must be provided to TDWG. The Contractor shall provide responses from the subcontractors to address these concerns and plans for corrective action.

The Contractor shall ensure this requirement flows down to all contractual arrangements with Laboratories.

• Contractor shall notify AO and AOR a minimum of 10 business days in advance of upcoming, audits/site visits of subcontractors

• Contractor shall notify the AOR and AO within 5 business days of report completion.

• AOR and AO will review the report and provide a response to the Contractor with 10 business days

03.4 Risk Management

Plan (RMP)

The Contractor shall provide a RMP that outlines the impacts of each risk in relation to the cost, schedule, and performance objectives. The plan shall include risk mitigation strategies. Each risk mitigation strategy will capture how the corrective action will reduce impacts on cost, schedule and performance.

• A Draft is due 10 business days after award;

updates to the RMP are due concurrent with Monthly Technical Progress Reports. The contractor may choose to notify the Government up to two times every three months if there are no changes from the prior submission, and not submit an update

• TDWG will provide Contractor with a list of concerns in response plan submitted

• Contractor must address, in writing, all concerns raised by TDWG within 20 business days of Contractor’s receipt of TDWG’s concerns

03.5 Integrated Master

Schedule (IMS)

The contractor shall provide an IMS that illustrates project tasks, dependencies, durations throughout the period of performance, and milestones (GO/NO- GO). The IMS must map to the WBS, and provide baseline, and actual or forecast dates for completion of tasks

• The IMS is to be submitted in both PDF and Microsoft Project Form to the AOR

• The first Draft of the IMS is due at the OTA kickoff meeting (see OTADRL 01.1).

• The Government will request revisions within 10 business days, at which point the schedule baseline for the period of performance will be set

• There after an updated IMS is due concurrent with Monthly Technical Progress Reports

• During a declared Public Health Emergency, the IMS is to be delivered within 10 days of award, updates are due weekly, and any significant change (I.e. a change which would impact the schedule by greater than one week) must be reported immediately to the AOR and/or designee.

03.6 Deviation Notification

and Mitigation Strategy

Process for changing IMS activities associated with cost and schedule as baselined. Contractor shall notify TDWG of significant proposed changes the IMS defined as increases in cost above 5% or schedule slippage of more than 30 days, which would require a PoP extension.

Contractor shall provide a high level management strategy for risk mitigation

• Due at least 10 business days prior to the Contractor anticipating the need to implement changes

03.7 Incident Report Contractor shall communicate to TDWG

and document all critical programmatic concerns, issues, or probable risks that have or are likely to significantly impact project schedule and/or cost and/or performance. “Significant” is frequently defined as a 10% or greater cost or schedule variance within a control account, but should be confirmed in consultation with the AOR. Incidents that present liability to the project even without cost/schedule impact, such as breach of GCP during a clinical study, must also be reported

• Due within 48 hours of activity or incident or within 24 hours for a security activity or incident

• Email or telephone with written follow-up to AOR and AO

• Additional updates due to AOR and AO within 48 hours of additional developments

• Contractor shall submit within 5 business days a Corrective Action Plan (if deemed necessary by either party) to address any potential issues

• If Corrective action is deemed necessary, Contractor must address in writing, its consideration of concerns raised by TDWG within 5 business days of receiving such concerns

10 Regulatory Documents

10.1 FDA and CMS

Correspondence

The Contractor shall memorialize any Correspondence (including formal submissions and informal correspondence) between the FDA, CMS and Contractor or any participating Laboratory and submit to TDWG. The Contractor shall ensure this requirement flows down to all contractual arrangements with Laboratories.

• Contractor shall provide copies of any FDA and CMS Correspondence within 2 business days of correspondence

10.2 Adverse Event

Reporting

Contractor shall, and shall ensure that Laboratories (i) report to the FDA and manufacturer in accordance with 21 C.F.R. Part 803; (ii) report adverse events, including problems with test kits and related components, as well as performance and results, to MedWatch by submitting the online FDA Form 3500 or by calling 1-800-FDA-1088; and (iii) comply with CMS reporting requirements, as applicable to testing performed under this Agreement.

If at any time a device being used in the fulfillment of this Agreement is removed from the FDA list of authorized, approved, or cleared products, Contractor must and must ensure its Laboratories immediately cease using said device to fulfill its obligations under this OTA.

The Contractor shall ensure this requirement flows down to all contractual arrangements with Laboratories.

• Contractor shall provide copies of any report submitted to FDA or CMS related to adverse events or testing performance issues, within 2 business days of report submission. For any reports that are submitted orally to the 1-800 FDA line, Contractor shall provide a written summary to the AOR.

• Contractor shall notify the AOR within 2 business days if a device being used in fulfillment of this Agreement is removed from the FDA list of authorized, approved or cleared products; and shall also provide copies of related correspondence with Laboratories

11 Press Release

11.1 Press Releases Contractor agrees to accurately and

factually represent the work conducted under this OTA in all press releases.

• Contractor shall ensure that the AO has received and approved an advanced copy of any press release to this OTA not less than 5 business days prior to the issuance of the press release

• If corrective action is required, the Contractor agrees to accurately and factually represent the work conducted under this OTA in all press releases

• Any final press releases shall be submitted to

• TDWG no later than 1 calendar day prior to its release