Att_C_QASP_NCBI_07222019.pdf

Attachment C

Quality Assurance Surveillance Plan (QASP)

National Cord Blood Inventory Contract

July 22, 2019

1 Introduction

1.1 Mission

1.2 Purpose

1.3 Authority

1.4 Roles and Responsibilities

1.5 Program/Project Manager (PM)

1.6 Contracting Office

1.7 Contracting Officer's Representative (COR)

1.8 Performance Requirements and Method of Surveillance

1.9 Contract Surveillance

1.10 Surveillance Matrix

Attachment 1 - Surveillance Matrix Attachment 2 – Surveillance Matrix ………………………………………………………...23

Quality Assurance Surveillance Plan (QASP)

National Cord Blood Inventory

1 Introduction The Division of Transplantation, Healthcare Systems Bureau, Health Resources and Services Administration (HRSA), is seeking to contract with cord blood banks (CBBs) to continue to build the National Cord Blood Inventory (NCBI) by adding new, high-quality, genetically diverse cord blood units (CBUs). CBUs added to the NCBI are available to patients through HRSA’s C.W. Bill Young Cell Transplantation Program (CWBYCTP). Some CBUs collected for the NCBI that are not suitable for clinical use are available to researchers for peer-reviewed research activities.

1.1 Mission

The NCBI supports HRSA's mission to improve access to quality healthcare and services by contracting services to achieve the statutory goal of adding at least 150,000 new, high-quality, genetically diverse CBUs to the NCBI and making these CBUs available through the CWBYCTP.

1.2 Purpose

The purpose of this contract is to increase cord blood collections by public cord blood banks, add new, high-quality, genetically diverse CBUs to the NCBI and make these units available through the CWBYCTP, and make CBUs not suitable for clinical use available for peer-review research activities.

1.3 Authority

Authority for issuance of this QASP is provided under Part 46 of the Federal Acquisition Regulation, Inspection of Services clauses, which provides for inspection, acceptance and documentation of the service called for in the contract or order. This acceptance is to be executed by the contracting officer or a duly authorized representative.

1.4 Roles and Responsibilities

The following personnel shall oversee and coordinate surveillance activities.

1.5 Program/Project Manager (PM)

The PM provides primary program oversight, nominates the COR, ensures the COR is trained before performing any COR duties and supports the COR's performance assessment activities.

While the PM may serve as a direct conduit to provide Government guidance and feedback to the Contractor on technical matters, they are not empowered to make any contractual commitments or any contract changes on the Government's behalf.

Assigned PM: Mesmin Germain Organization or Agency: HHS/HRSA/HSB/DoT Telephone: (301) 443-0053 Email: MGermain@hrsa.gov

1.6 Contracting Office

The Contract Specialist shall ensure performance of all necessary actions for effective contracting, ensure compliance with the contract terms, and shall safeguard the interests of the United States in the contractual relationship. The Contract Specialist shall also ensure that the Contractor receives impartial, fair, and equitable treatment under this contract. Determine and document the final assessment of the Contractor's performance in the Government’s Past Performance Information Retrieval System.

Assigned Contract Specialist:

Organization or Agency: HHS/HRSA/OAFM Telephone:

(301) Email:

1.7 Contracting Officer's Representative (COR)

The COR is responsible for providing continuous technical oversight of the Contractor's performance. The COR uses the QASP to conduct the oversight/surveillance process. The COR shall keep a quality assurance file that accurately documents the Contractor's actual performance. The purpose is to ensure that the Contractor meets the performance standards contained in the contract. The COR is responsible for reporting early identification of performance problems to the Contract Specialist. The COR is required to provide to the Contract Specialist an annual performance assessment, which will be used in documenting past performance. The QASP is the primary tool for documenting Contractor performance. The COR is not empowered to make any contractual commitments or to authorize any contractual change on the Government's behalf.

Assigned Contracting Officer's Representative:

Organization or Agency: HHS/HRSA/HSB/DoT Telephone: (301)

Email:

1.8 Performance Requirements and Method of Surveillance

This section describes the special requirements for this effort. The following sub- sections provide details of various considerations on this effort.

1.9 Contract Surveillance

The goal of the QASP is to ensure that the Contractor's performance is effectively monitored and documented. The COR's contribution is their professional, non- adversarial relationships with the Contract Specialist, PM and the Contractor, which enables positive, open and timely communications. The foundation of this relationship is built upon objective, fair, and consistent COR evaluations of Contractor’s mailto:MGermain@hrsa.gov performance against contract requirements. The COR uses the methods contained in this QASP to ensure the Contractor is in compliance with contract requirements. The QASP contains a wide range of surveillance requirements that effectively measure and evaluate the Contractor's performance. The COR shall inform the Contractor when the task performance does not meet the performance standard. Additionally, this QASP is based on the premise that the Contractor, not the Government, is responsible for management and quality control (QC)/quality assurance (QA) actions to successfully meet the terms of the contract.

1.10 Surveillance Matrix

The Surveillance Matrix (Attachment 1) is the list of performance objectives and standards that must be performed by the Contractor. This matrix details the method of surveillance the COR will use to validate and inspect these performance elements.

Inspection of each element will be documented in the COR file.

Performance objectives define the desired outcomes. Performance standards define the level of service required under the contract to successfully meet the performance objective. The inspection methodology defines how, when, and what will be assessed in measuring performance. The Government performs surveillance, using this QASP, to determine the quality of the Contractor's performance as it relates to the performance element standards.

In evaluating the quality of Contractor’s performance, the following performance ratings may be used.

Performance Rating

Criteria

Excellent/Outstanding Performance meets contractual requirements and exceeds many to the Government’s benefit. The contractual performance of the element or sub-element being assessed was accomplished with few minor problems for which corrective actions taken by the Contractor was highly effective.

Very Good Performance meets contractual requirements and exceeds some to the Government’s benefit. The contractual performance of the element or sub-element being assessed was accomplished with some minor problems for which corrective actions taken by the Contractor was effective.

Satisfactory Performance meets contractual requirements. The contractual performance of the element or sub-element contains some minor problems for which corrective actions taken by the Contractor appear or were satisfactory.

Marginal Performance does not meet some contractual requirements. The contractual performance of the element or sub-element being assessed reflects a serious problem for which the Contractor has not yet identified corrective actions. The Contractor’s proposed actions appear only marginally effective or were not fully implemented.

Unsatisfactory Performance does not meet most contractual requirements and recovery is not likely in a timely manner. The contractual performance of the element or sub-element contains a serious problem(s) for which the Contractor’s corrective actions appear or were ineffective.

Attachment 1: Surveillance Matrix PWS Task # and Description Deliverable Number(s)

Performance Standards/ Acceptable Quality Level (AQL)

Inspection by COR for contract compliance Frequency per PWS Task delivery and Schedules of Deliverables

Ratings

1 1 Federal Records Management

1 1) Submission of documentation on how the Contractor manages, maintains, and disposes of Federal Government Records per the task and Schedules of Deliverables.

2) The documentation shall include procedures for managing, maintaining, and disposing of Federal records.

Documents submitted per the Schedule of Deliverables

2 2 Federal Records Management Training

2 1) The status of the number and percentage of staff who completed training is included in the initial report, interim, and annual reports per the Schedule of Deliverables. Interim reports shall be submitted for any revisions to the previously submitted list. The report shall include the course title. The reports shall include a statement certifying HRSA records management training has been completed by all employees performing work under this contract and having access to (1) Federal information or a Federal information system, or (2) personally identifiable information (PII)Any new employee hired after the training implementation date is required to complete the training before performing work under this contract.

2) HRSA OIT records management training shall be implemented in accordance with the Schedule of Deliverables.

Documents submitted per the Schedule of

3 3.1 HRSA OIT:

Baseline Security Requirements

3 1) Meet with COR and HRSA OIT Security within 30 days after the EDOC.

2) Submission of security and privacy documents as scheduled to demonstrate compliance with security and privacy requirements.

1) Meeting participation

2) Documents submitted per

Schedule of and Description Deliverable Number(s)

Performance Standards/ Acceptable Quality Level (AQL)

Inspection by COR for contract compliance Frequency per PWS Task delivery and Schedules of Deliverables

Ratings

Deliverables

4 3.2 HRSA OIT:

Incident Response

4 1) Meet with COR and HRSA OIT Security within 30 days after the EDOC.

2) Submission of security and privacy documents as scheduled to demonstrate compliance with security and privacy requirements.

1) Meeting participation

2) Documents submitted per

5 3.3 HRSA OIT:

Contract Initiation and Expiration

5 1) Meet with COR and HRSA OIT Security within 30 days after the EDOC.

2) Submission of security and privacy documents as scheduled to demonstrate compliance with security and privacy requirements.

1) Meeting

2) Documents submitted per

6 4.1 Comply with CWBYCTP and

NCBI

Requirements

6 1) All (100%) NCBI CBUs shall be available through the CWBYCTP until the CBUs are released for therapy to a designated patient through an FDA BLA or IND, no longer eligible per contract requirements, or transferred to another NCBI contract.

2) Submits NCBI CBU pre-transplant data for indications required by SCTOD within six (6) months of the CBU shipment date for 85% of CBUs released for therapy to a designated patient through an FDA BLA or IND and not distributed through CWBYCTP

SPA-CC.

3) No more than one (1) privacy and confidentiality violation per fiscal year.

4) The revised description of data submission to the SCTOD shall require no more than one (1) revision.

1) Progress Reports

2) CWBYCTP SPA-

CC Confidentiality Reports

3) SCTOD Data Submission Description

7 4.2.1 Attend Initial/Kick-off

7, 8 1) Meet with Government staff in accordance with the Schedule of Deliverables.

1) Response to meeting request and Description Deliverable Number(s)

Performance Standards/ Acceptable Quality Level (AQL)

Inspection by COR for contract compliance Frequency per PWS Task delivery and Schedules of Deliverables

Ratings

Meeting 2) Respond to the request to schedule the meeting within three (3) calendar days.

3) Respond to the request to confirm the meeting within three (3) calendar days with its meeting participants by name, position, and role in the contract. The Project Director and Coordinator shall participate in the meeting.

4) Submit meeting minutes to the COR within three (3) calendar days after the kick-off meeting.

5) Meeting minutes shall require no more than one (1) revision after the COR’s comments are provided to the Contractor.

2) Meeting participation

3) Meeting minutes

8 4.2.2 Attend Annual Progress Meetings

9, 10 1) Meet with Government staff in accordance with the Schedule of Deliverables.

2) Respond to the request to schedule the meeting within three (3) calendar days.

3) Respond to the request to confirm the meeting date and time within three (3) calendar days with its participants by name, position, and role in the contract in the response confirming the meeting.

4) Lead the review of contract progress against contract plans and schedules while highlighting any delays and/or issues affecting the contract; no pre-meeting materials required.

5) Submit meeting minutes to the COR within three (3) calendar days after the meeting.

6) Meeting minutes require no more than one (1) revision after the COR’s comments are provided to the Contractor.

1) Response to meeting request

2) Meeting

3) Meeting minutes

9 4.2.3 Host Site 11,12,13 1) Meet with Government staff in accordance with the 1) Response to and Description Deliverable Number(s)

Performance Standards/ Acceptable Quality Level (AQL)

Inspection by COR for contract compliance Frequency per PWS Task delivery and Schedules of Deliverables

Ratings

Visits Schedule of Deliverables.

2) Respond to the request to schedule the site visit within three (3) calendar days.

3) Respond to the request to confirm the visit dates within three (3) calendar days with its site visit participants by name, position, and role in the contract in the response confirming the visit dates.

4) The agenda shall require no more than one revision after the COR’s comments are provided to the Contractor.

5) Onsite contract designated key personnel and other staff performing contract activities shall be present to meet with government staff.

6) Meeting minutes require no more than one (1) revision after the COR’s comments are provided to the Contractor.

meeting request and confirmation

2) Agenda

3) Meeting participation

4) Meeting minutes

10 4.3.1 Operate a Cord Blood Bank

14, 15, 16,

1) Submit required documentation per the timeframe specified in the Schedule of Deliverables.

2) Make task notifications to the COR in accordance with the Schedules of Deliverables.

1) Document submissions

2) COR Notifications

11 4.3.2 Maintain Cord Blood Collection Sites

18 1) Achieve at least 95% of CBU collections and 100% CBU deliveries, from collection sites with agreements, per the approved contract CBU collection and CBU delivery schedules.

2) In accordance with the Schedule of Deliverables and progress report tasks, the Contractor shall submit copies of signed, dated, and executed agreements between the Contractor and the collection sites for NCBI collections before initiating contract

1) Agreements

2) Progress Reports and Description Deliverable Number(s)

Performance Standards/ Acceptable Quality Level (AQL)

Inspection by COR for contract compliance Frequency per PWS Task delivery and Schedules of Deliverables

Ratings collections at sites.

3) In accordance with the Schedule of Deliverables and progress report tasks, the Contractor shall submit executed copies of revised or amended agreements, including renewals before previous agreements expire.

12 4.3.3 Expand

Collections at Existing or New Sites

19 1) The revised plan shall require no more than one (1) revision after the COR’s comments on the revised plan are provided to the Contractor.

2) The Contractor shall achieve 90% of its CBU collections per the plan’s projections.

1) Plan

2) Annual progress update

13 4.3.4 Maintain a CBU Collection Schedule

20 1) The revised plan shall require no more than one (1) revision after the COR’s comments on the revised plan are provided to the Contractor. No revisions of the schedule once the COR approves it, unless agreed to in writing by the Contracting Officer.

2) The quantity of NCBI CBU collections shall be at least 95% of the approved NCBI CBU collection schedule quantity for the contract year and shall be of sufficient quantity to achieve NCBI CBU delivery quantities by race and ethnicity as specified in Section B.2. Price by the delivery schedule.

1) Schedule

14 4.3.5 Maintain Cord Blood Unit (CBU) Delivery Schedule

21 1) The revised schedule shall require no more than one

(1) revision after the COR’s comments on the schedule are provided to the Contractor. The schedule shall not be revised after it is approved by the COR, unless agreed to in writing by the Contracting Officer.

1) Schedule and Description Deliverable Number(s)

Performance Standards/ Acceptable Quality Level (AQL)

Inspection by COR for contract compliance Frequency per PWS Task delivery and Schedules of Deliverables

Ratings

2) NCBI CBUs collected outside of the timeframe specified for each contract year shall not be accepted.

3) NCBI CBUs delivered outside of the timeframe specified for each contract year shall not be accepted.

4) NCBI CBUs shall meet or exceed the minimum CBU quantities, by contract year, for each service delivery period by the schedule in Attachment 2, Surveillance Matrix, Task 3.3.5.

15 4.3.6 Specify

NCBI CBU

Characteristics and Specifications

22 All (100%) CBUs delivered meet the requirements of the characteristics and specifications.

1) NCBI CBU

Characteristics and Specifications description

2) Progress Reports

3) SPA-CC NCBI

CBU Reports

16 4.3.7 Define and Report CBU Broad Race and Ethnicity

Applies to all contract deliverables and submissions

No more than one (1) revision to correct broad race and ethnicity category per document type submitted to the COR per a Federal fiscal year.

Document submissions.

17 4.3.8 Maintain

NCBI CBU

Availability Status

25, 26, 27 1) Total (100%) CBU accountability per the defined status categories.

2) CBUs with a status of Not Available for 12 consecutive months shall be removed from the NCBI (and replaced). The Contractor shall replace CBUs removed from the NCBI within 30-days of the removal from the NCBI.

1) Progress Reports

2) SPA-CC NCBI

18 4.3.9 Remove and Replace

25, 26, 27 1) All (100%) removed CBUs shall be replaced within 30-days of the NCBI removal date.

1) Progress Reports

2) SPA-CC NCBI

and Description Deliverable Number(s)

Performance Standards/ Acceptable Quality Level (AQL)

Inspection by COR for contract compliance Frequency per PWS Task delivery and Schedules of Deliverables

Ratings

NCBI CBUs 2) No more than one (1) resubmission of documentation required for invoicing NCBI CBU because of pending CBU replacements per Federal fiscal year.

19 4.3.10 Provide CBU for Peer- Reviewed Research

25, 27 1) CBUs are provided for peer-reviewed research each month the Contractor delivers CBUs for the contract.

2) CBUs provided for peer-reviewed research are reported per the Schedule of Deliverables and progress report task. The report shall include information about CBU quantity, charges to researchers, and research study title or investigator name.

Progress Reports

20 4.3.11 Maintain a Contingency Plan

23 The revised plan shall require no revisions. Plan

21 4.3.12 Achieve Self Sufficiency

24 1) The revised plan shall require no more than one (1) revision after the COR’s comments on the revised plan are provided to the Contractor.

2) Implements the plan per the Schedule of Deliverables. The plan shall have a date for the achievement of self-sufficiency.

3) Achieves self-sufficiency within 3-years of entry date of contract (EDOC) and maintains it through the contract period of performance.

4) Achieves objectives for achieving self-sufficiency per timeline in the approved plan.

5) Achieves plan objectives within 6-months of the timelines in the approved plan.

6) Addresses how the Contractor shall financially sustain its public cord blood inventory throughout the

Plan

1) Annual progress updates and Description Deliverable Number(s)

Performance Standards/ Acceptable Quality Level (AQL)

Inspection by COR for contract compliance Frequency per PWS Task delivery and Schedules of Deliverables

Ratings period of performance. The plan shall address the expenses not recovered from revenues, and how the Contractor resolves amounts not recovered from revenues.

7) Evaluates its progress against the plan each fiscal year (October 1-September 30).

8) Submits the progress report information per the progress report tasks.

22 4.4.1 Verify Submissions to the Government for Accuracy

Applies to all contract deliverables and submissions

No more than one contract report (1) submission per Federal fiscal year requires revision because of discrepancies amongst documents.

Document submissions.

23 4.4.2 Submit Monthly Progress Reports

25 1) Submit reports in accordance with progress reports and the Schedule of Deliverables.

2) Submit the content of the reports in an organized, easily viewed electronic format that printable on letter, legal, or 11 x 17, sized paper with all information printable within the margins.

3) Submit electronic formats: Two (2) formats of each document shall be submitted (one in PDF and the other in MS Word, Excel, Access or other native format as agreed to by the COR).

4) Reports shall require no more than one (1) revision per each type of progress report submitted.

Progress Reports

24 4.4.3 Submit Annual Progress Reports

26 1) Submit reports in accordance with progress reports and the Schedule of Deliverables.

2) Submit the content of the reports in an organized, easily viewed electronic format that printable on and Description Deliverable Number(s)

Performance Standards/ Acceptable Quality Level (AQL)

Inspection by COR for contract compliance Frequency per PWS Task delivery and Schedules of Deliverables

Ratings letter, legal, or 11 x 17, sized paper with all information printable within the margins.

3) Submit electronic formats: Two (2) formats of each document shall be submitted (one in PDF and the other in MS Word, Excel, Access or other native format as agreed to by the COR).

4) Reports shall require no more than one (1) revision per each type of progress report submitted.

5) For monthly progress reports that do not have an annual progress report requirement, the September report of each year shall serve as the annual progress report for that fiscal year.

25 4.4.4 Submit Final Progress Report

27 1) Submit reports in accordance with progress reports and the Schedule of Deliverables.

2) Submit the content of the reports in an organized, easily viewed electronic format that printable on letter, legal, or 11 x 17, sized paper with all information printable within the margins.

3) Submit electronic formats: Two (2) formats of each document shall be submitted (one in PDF and the other in MS Word, Excel, Access or other native format as agreed to by the COR).

4) Reports shall require no more than one (1) revision per each type of progress report submitted.

Attachment 2: Surveillance Matrix, Task 4.3.5 Task: 4.3.5 Maintain Cord Blood Unit (CBU) Delivery Schedule Performance Standard #4:

NCBI CBUs shall meet or exceed the minimum CBU quantities, by contract year, for each service delivery period by the schedule below:

Contract Year Quantities as specified in Section B.2, Price

50% of CBU delivered * by

75% of CBU delivered* by

100% of CBU delivered* by

Year 1 May 31, 2020 July, 31, 2020 September 30, 2020 Subsequent years

March 31 June 30 September 30

For example, Year 2 CBU delivery period dates are:

March 31, 2021 June 30, 2021 September 30, 2021

*A CBU registered with CWBYCTP SPA-CC, listed on a CWBYCTP SPA-CC NCBI CBU certifying report, and listed on a monthly contract progress report and eligible for the NCBI. For CBU delivery, the monthly contract progress report and the NCBI CBU certifying report shall have the same monthly reporting period as the CBU delivery month. Documentation for monthly CBU delivery is submitted to CORs per the Schedules of Deliverables and progress reports.