Exhibit G - QASP - 3.2.2023.docx

Exhibit G. - Quality Assurance Surveillance Plan (QASP)

1. Introduction

1.1 Since this is a Performance-Based Contract, the Government must effectively validate in a timely manner the performance of the Contractor in meeting the services required. This QASP provides a systematic surveillance method for the services, and describes the methodology by which the Contractor’s performance will be monitored.

1.2 The principal focus of the surveillance system is the Contractor’s performance in providing the services identified in the Performancebased PWS. The contractor performance assessment addresses the following areas: Quality of Service, EDI Transmission, Timeliness, and Business Relation.

1.3 The contract will be surveilled with the Performance-based Matrix listed in the contract

1.4 The Contracting Officer’s Representative (COR) will use the Contractors Performance Assessment Reporting System (CPARS) to electronically process interim and final contractor performance assessments at www.cpars.gov. At a minimum, interim contractor performance assessments will be conducted every 12 months until the end of the contract.

1.5 For the purpose of this plan, The Centers for Disease Control and Prevention will consider the Performance Based Matricies to meet the FAR Part 37.601 criteria.

1.6 This QASP:

0. Identifies the service and products that will be measured.

0. Establishes the specific standards of performance for each required output.

0. Establishes the responsibilities for performing the measurement.

0. Defines the Government role in overseeing the performance.

0. Provides for feedback to the Contractor regarding Quality of Service, EDI Transmission, Timeliness, and Business Relations

0. Establishes timeframes for communicating performance improvements

1. Methods of Surveillance:

2.1 The Performance-Based Matrix lists the services to be monitored and the standards to be applied.

2.2 This QASP is based on the premise the government requires to maintain a quality standard for distribution services.

2.3 The Contractor, and not the government, is responsible for management and quality control actions to meet the terms of the contract. The role of the government is quality assurance to ensure contract standards are achieved.

2.4 In this contract the Contractor’s quality control program is the basis for service quality.

3.0 Roles and Responsibilities:

3.1 The Contractor’s primary responsibility is to ensure all requirements are met at the required quality level. The Government shall ensure this responsibility has been met before payment is made to the Contractor. The primary Government team members are the COR, and the Contracting Officer (CO).

3.2 The CO has the overall responsibility for overseeing the Contractor’s performance. The CO is responsible for monitoring Contractor performance in the areas of contract compliance, contract management, and the resolution of all issues relative to the language of the contract.

3.3 The COR is responsible for directly monitoring, assessing, recording, and reporting on the technical performance of the Contractor. The COR will have primary responsibility for documenting the inspection and evaluation of the Contractor’s performance.

3.4 The COR will work with the Contractor to ensure good communication and resolve any problems not requiring the CO’s authority.

4.0 Surveillance: The COR or designee will conduct at least two scheduled site visits (inspections) annually to each facility storing and shipping vaccine. Two announced and may perform 1-2 unannounced additional visits, CDC reserves the right to conduct other additional scheduled and unscheduled site visits (inspections) as well. CDC also reserves the right to conduct a full inventory of the stockpile and/or operating inventory during site visits.

Contractor assessments made during announced and unannounced site visits shall include but may not be limited to:

A. Vaccine in stockpile and in operating inventory is stored, handled and controlled so as to assure viability of vaccine through expiration date

· Vaccine storage temperatures are continuously monitored and are within prescribed temperature ranges, as defined by the product inserts, to assure viability through vaccine expiration date.

· Storage temperature alarms are in place and functional.

· The back-up power generator is in place and functional.

· Perimeter security systems are in place and functional.

· All staff handling, storing, packing and shipping vaccine have received annual training, documented by contractor.

B. The staff’s adherence to packing and shipping procedures that were outlined in the SOPs and the agreed-upon technical approach.

· Vaccine is packed directly from refrigerated units into validated shipping containers.

· Appropriate refrigerant is included in package

· Insulating material separates vaccine from refrigerant.

· Cold chain monitors are included with vaccine.

· Appropriate information is included on the packing slip.

· Shipments are properly labeled.

C. Vaccine stockpile and operating inventory is effectively managed.

· Stockpile and operating inventory are stored in secured locations separately from any commercial stock.

· Inventory reports accurately reflect physical inventory.

· CDC reserves the right to conduct a full physical inventory of stockpile and/or operating inventory during a site visit.

CDC will periodically conduct a satisfaction survey of projects served by the contractor. This survey will assess Project satisfaction with management of project-specific vaccine inventory and the quality and responsiveness of service provided to Projects and Project Providers.

4.1 All performance must be documented whether acceptable or unacceptable. When unacceptable performance is documented, the COR shall take the following actions:

4.1.1 If government actions caused the unacceptable performance, take steps to prevent it in the future.

4.1.2 If the Contractor’s performance is unacceptable, inform the Contractor’s on-site representative of the unacceptable performance and the reasons why it is unacceptable.

4.1.3 If the contractor disputes the results of the surveillance, refer them to the CO for resolution.

4.2 Performance should not be determined unacceptable until all possible contributing factors have been considered.

4.3 For required tasks not shown on the Performance-Based Matrix, the government still retains the right to inspect any item included in the contract. These services will be inspected periodically, and the results provided to the CO.

5.0 Standards: All standards in the Performance-Based Matrix must be met. All deliverable dates and other contractual completion dates must also be met. If any of the standards are not met, the Government shall receive consideration from the Contractor for breach of contract.

5.1 Late performance is un-excusable unless the Contractor can justify all of the following:

5.1.1 The delay was not the Contractor’s fault.

5.1.2 The delay was not foreseeable.

5.1.3 It was beyond the Contractor’s control to avoid the delay.

5.2 All work shall be performed in accordance with the PWS. The COR shall not consider the services complete until all deficiencies have been corrected.

5.3 The COR shall determine whether the failure was a minor non-conformance or a substantive non-conformance.

6.0 Procedures: The Government will inspect performance requirements to ensure contractor compliance and record results of inspection, noting the date and time of inspection. Unacceptable performance and complaints shall be referred to the CO for investigation and validation. The CO will investigate and validate the unacceptable performance and/or customer input. The Contractor shall be given a reasonable amount of time after notification to correct the unacceptable performance and report to the CO that the deficiency has been corrected. If deficiencies are not corrected, the COR will notify the CO and recommend a course of action.

7.0 Contract Performance Evaluation

7.1 FAR subpart 42.15 – Contractor Performance Information establishes the Government responsibility for recording and maintaining contractor performance information. This requirement does not apply to procedures used in determining incentive awards or other incentive systems, although the two systems should be mutually supporting.

7.2 FAR subpart 42.1501 – Past Performance Information is relevant information for future source selection purposes, regarding a contractor’s actions under previously awarded contracts. It includes, for example, the contractor’s record of conforming to contract requirements and to standards of good workmanship; the contractor’s record of forecasting and controlling costs; the contractor’s adherence to contract schedules, including the administrative aspects of performance; the contractor’s history of reasonable and cooperative behavior and commitment to customer satisfaction; and generally, the contractor’s business-like concern for the interest of their customers.

8.0 Performance Based Matrix (Sections 21 and Pandemic 15.16 in the PWS) Below are two performance-based matrices. The first is the Performance Based Matrix and the second is for the Pandemic Performance Based Matrix.

PWS Section 21. - Performance Based Matrix

Performance Standard Monitoring Method Incentive / Disincentive

Quality of Service

CDC Minimum Standard: 99.5%

Monthly analysis and review of 100% of orders delivered

Performance in this area will be documented and provided as past performance information. For orders that are not correct in terms of vaccines or quantities, the Contractor shall assume costs due to over shipment of vaccines and/or costs associated with retrieval of vaccine and reshipment of the correct order.

Monthly analysis and review of 100% of orders delivered

Performance in this area will be documented and provided as past performance information. For orders where cold chain is not maintained (excluding orders where temperature excursions are due to incorrect provider information), the Contractor shall assume costs related to vaccine replacement and reshipment.

CDC Minimum Standard: 98% Reconciliation of CDC and Contractor inventory annually

Performance in this area will be documented and provided as past performance information. The Contractor shall be required to replace any discrepancies in inventory between CDC records and Contractor report of inventory that cannot be reconciled.

CDC Minimum Standard: 100%

CDC will validate system inventory reports

Performance in this area will be documented and provided as past performance information. The Contractor shall be required to replace any discrepancies in inventory between CDC records and Contractor report of inventory that cannot be reconciled. Payment for storage of stockpiled vaccine by CDC will only cover the actual number of doses placed in the stockpile by CDC.

CDC Minimum Standard: 99%

Performance Standard Monitoring Method Incentive / Disincentive

EDI Transmission

852 data/format errors Exclusions: When CDC system is responsible for the delay or failure of the message Offeror Proposal

852 = % of messages sent without data/format errors that cause the message transmission to fail

Performance in this area will be documented and provided as past performance information.

855 Errors

Offeror Proposal

997 Errors

Offeror Proposal

Performance Standard Monitoring Method Incentive / Disincentive

Timeliness

100% of routine orders shipped within one to four business days

Exclusions: Orders with vaccine on backorder.

Offeror Proposal

CDC Minimum Standard: 98.75%

Monthly analysis and review of 100% of orders delivered minus exceptions.

All shipments are in accordance with the provider’s receiving hours.

Performance in this area will be documented and provided as past performance information.

Priority items shipped same business day

Exclusions: Item ordered as priority is on backorder.

Offeror Proposal

CDC Minimum Standard: 96%

Monthly analysis and review of 100% of orders delivered minus exclusions

Orders received after 4:00 p.m. local depot time shall be shipped on the next business day. All shipments are in accordance with the provider’s receiving hours.

*Orders shipped on Friday for Saturday delivery must be approved by CDC prior to shipment

Performance in this area will be documented and provided as past performance information.

Influenza vaccine orders shipped within one to two business days or less

Exclusion: Item ordered is on backorder

Offeror Proposal

CDC Minimum Standard: 95%

Weekly analysis and review of 100% of orders delivered minus exclusions

All shipments are in accordance with the provider’s receiving hours.

Performance in this area will be documented and provided as past performance information.

CDC replenishment orders, Awardee funded non-flu orders, and Awardee funded influenza orders received into inventory and IT system and transmitted to CDC and/or Awardee. within 24 hours of the next business day following receipt from the manufacturer at the Contractor depot loading dock. For example, if receipt is at 10am local depot time, the vaccine shall be available for shipment by 10am the next business.

Offeror Proposal

Monthly analysis and review of Contractor-submitted receipt data

Performance in this area will be documented and provided as past performance information.

Depot to depot transfer delivered within 3 business days of direction by CDC

Offeror Proposal

CDC Minimum Standard: 99.00%

Monthly analysis and review of Contractor-submitted receipt data

Performance in this area will be documented and provided as past performance information.

Note: Provider Office Receiving hours: Providers are required to be open at least one day a week, other than Monday for four or more consecutive hours during the business day.

Performance Standard Monitoring Method Incentive / Disincentive

Business Relations

CDC Minimum Standard: 90%

CDC Minimum Standard: < 1%

PWS Section 15.16 - Pandemic Performance Based Matrix

Performance Standard Monitoring Method Incentive / Disincentive

Quality of Service

Monthly analysis and review of 100% of orders delivered

Performance in this area will be documented and provided as past performance information. For orders that are not correct in terms of vaccines or quantities, the Contractor shall assume costs due to over shipment of vaccines and/or costs associated with retrieval of vaccine and reshipment of the correct order.

Monthly analysis and review of 100% of orders delivered

Performance in this area will be documented and provided as past performance information. For orders where cold chain is not maintained (excluding orders where temperature excursions are due to incorrect provider information), the Contractor shall assume costs related to vaccine replacement and reshipment.

CDC Minimum Standard: 98.0% Reconciliation of CDC and Contractor inventory annually

Performance in this area will be documented and provided as past performance information. The Contractor shall be required to replace any discrepancies in inventory between CDC records and Contractor report of inventory that cannot be reconciled.

CDC Minimum Standard: 98.5%

CDC will validate system inventory reports Performance in this area will be documented and provided as past performance information.

Performance Standard Monitoring Method Incentive / Disincentive

EDI Transmission

852 data/format errors

Offeror Proposal

852 = % of messages sent without data/format errors that cause the message transmission to fail

Performance in this area will be documented and provided as past performance information.

855 Errors

Offeror Proposal

CDC Minimum Standard: 98.00%

855 = % of order acknowledgements received by 9:00 am of next business day for orders the previous day Performance in this area will be documented and provided as past performance information.

997 Errors

Offeror Proposal

CDC Minimum Standard: 98.00%

Performance Standard Monitoring Method Incentive / Disincentive

Timeliness

Pandemic orders shipped out same day the order was received, except for Friday, which will ship on Sunday.

Exclusions: Item ordered is on backorder.

Offer Proposal

Weekly analysis and review of 100% of orders delivered minus exceptions.

Offer’s Proposed daily cutoff time

CDC Minimum Cutoff time:

12:00 noon ET

All shipments are in accordance with the provider’s receiving hours.

Performance in this area will be documented and provided as past performance information.

Monthly analysis and review of 100% of orders delivered minus exceptions; sample of orders reviewed to confirm equivalent service level between ancillary kit and vaccine/adjuvant components.

Ancillary kits shipped out same day and same service level as the vaccine/adjuvant component of the order.

Performance in this area will be

CDC Minimum Standard: 95.00%

Monthly analysis and review of Contractor-submitted receipt data Performance in this area will be documented and provided as past performance information.

Pandemic depot to depot transfer delivered within 3 business days of direction by CDC

Offeror

CDC Minimum Standard: 99.00%

Monthly analysis and review of Contractor-submitted receipt data

Performance in this area will be

Performance Standard Monitoring Method Incentive / Disincentive

Business Relations

Customer service tickets fully resolved within 24 hours.

Offeror Proposal

CDC Minimum Standard: 95.0%

Customer service tickets re-opened due to lack of satisfactory resolution of original problems that was initially “resolved” within previous 3 business days.

Offeror Proposal

CDC Minimum Standard: <1%

provided as past performance information.