A01_-_Attach_1_-_Performance_Work_Statement_CTL_FINAL.pdf

PERFORMANCE WORK STATEMENT (PWS)

CONFORMANCE TESTING SERVICES FOR THE DEFENSE BIOLOGICAL PRODUCT

ASSURANCE OFFICE

12 February 2018

1.0 GENERAL

1.1 Introduction

The Joint Program Executive Office for Chemical, Biological, Radiological, and Nuclear Defense

(JPEO-CBRND), Joint Project Manager Guardian (JPMG), Defense Biological Product Assurance

Office (DBPAO) requires conformance testing of DBPAO products.

1.2 Background (For Informational Purposes Only)

DBPAO was established in 1997 by JPEO-CBD to support the need for an integrated biological defense capability and to ensure the standardization, quality, and availability of reagents and assays that are crucial to the successful development, test, and operation of Department of Defense (DoD) biological warfare defense detection systems and medical diagnostic products. The mission of the

DBPAO is to serve as the principal resource of high quality, validated, and standardized biological detection assays and reagents that meet the requirements of the Warfighter and Joint Biological

Defense Systems, and support the biological defense community by facilitating the transition of new technologies and coordinating their advanced development, efficient production, and timely distribution.

DBPAO is responsible for the development, production, conformance testing, stockpiling, and security of DBPAO products. DBPAO products include antibodies, polymerase chain reaction (PCR) assays, Electrochemiluminescence (ECL) assays, positive controls, lateral flow immunoassays (LFI) (e.g., hand held assays [HHAs], and biological sampling kits [BSK]) that are crucial to the mission of all current and future biological warfare agent detection and medical diagnostic systems. As a supporting program for all Biological Defense systems and a provider of stand-alone detection products, DBPAO supports the DoD and other military and civilian agencies through appropriate interagency-funded acquisition.

1.3 Scope

The scope of this effort is to provide conformance testing services to the DBPAO to include all effort required for the quality assurance/quality control (QA/QC) testing of Government Furnished Material

(GFM) such as: lateral flow immunoassay (LFI) strips that are assembled into hand held assays

(HHAs) and carriers for the Joint Biological Point Detection System (JBPDS) and the Joint Portal

Shield (JPS) system, as well as Electrochemiluminescence (ECL) assays, and ECL positive control.

The contractor shall provide data collection, data management and conformance test reports (CTRs).

The GFM provided for conformance testing will be delivered to the contractor from various production contractors. The Government will provide a projected production delivery list in order for the contractor to plan its testing schedule. As production lots are updated, the Government will provide refined testing requirements for the contractor to execute its tests.

The contractor shall advise and provide input to the Government, but shall not make final decisions or certifications on behalf of the Government nor perform any inherent Government functions. The contractor and its employees shall neither represent the Government nor appear to represent the

Government in performance of these services.

2.0 REQUIREMENTS

2.1 General

2.1.1 The contractor shall fulfill conformance testing requirements. The contractor is responsible for providing testing facilities and technical and analytical expertise for ongoing responsibilities delineated by activity, as well as variances in the scope of activities. The contractor shall appoint a program manager to monitor and manage contract activities and to serve as the overall expert for successful completion of this contract.

2.1.2 The contractor shall perform conformance testing on DBPAO products when sent by the

Government, and analyze the data for conformance to the performance criteria from the DBPAO provided conformance test plan. The contractor shall provide data management and documentation of all effort under this contract.

2.1.3 As this contract requires the contractor to handle biological materials, the contractor shall ensure that contractor personnel utilizing these materials have been trained by providing the Government with training certification and provide standard operating procedures (SOPs), and adhere to Federal, State, and local regulations with respect to the handling of these agents all of which is subject to Government approval. The contractor shall acknowledge that materials designated as Biosafety Level (BSL) 2 constitutes known pathogens. The contractor assumes all risk and responsibility in connection with the receipt, handling, storage, disposal, transfer and use of the material including, without limitation, taking all appropriate safety and handling precautions to minimize health or environmental risk. The contractor agrees that any activity undertaken with the material is conducted in compliance with all applicable guidelines, laws and regulations, including Department of Defense Instruction 5210.89

(DODI 5210.89) for DoD recipients and the Export Control Act.

2.1.4 The contractor shall provide, within two (2) days of Government inquiry, recommendations

(problem-solving, historical trends, best practices using their expertise and in accordance with applicable laws and regulations, and the time-sensitive nature of the Government’s requirements.

2.1.5 The contractor shall supply the components that are not Government Furnished Equipment

(GFE)/Government Furnished Material (GFM) and services necessary to perform conformance testing.

The Government will provide GFE/GFM to the contractor. The contractor shall provide storage for the

GFE/GFM. The contractor storage facility shall have environmental monitoring capability with back up systems to ensure storage requirements of GFE/GFM are met during power outages. The contractor shall account for all GFM and either dispose of excess GFM or return the stock as directed by the

COR and in accordance with Federal, State, and local statutes and regulations. The contractor shall use established commercial or military inventory management practices that facilitate inventory control.

2.1.6 The contractor shall prepare and submit General Incident Reports (CLINs 0001-0008) (A003) for any accidents such as spill, accidental release or material loss and other serious incidents such as conformance testing delay or work stoppage, difficulties or schedule slippage, loss of environmental control in the facility, and malfunction of required equipment throughout the life of this contract. The contractor shall submit written reports to the Contractor Officer’s Representative (COR) within three

(3) business days of incident occurrence and shall include incident description, contractor actions taken and contractor recommendations. The Contractor shall telephonically contact the Government within 24 hours of the incident.

2.2 Conformance Testing of DBPAO Products

2.2.1 Verification and Stability Testing of LFIs

2.2.1.1 Verification Testing of LFIs (CLIN 0001). The contractor shall adhere to and maintain the COR provided, most recent approved version of the DBPAO Conformance Test Plan (CTP) that outlines the verification acceptance test criteria and procedures for LFIs. The contractor shall perform SOP approved conformance tests on LFIs such as sensitivity, false positive reactions, dose response curves, cross- reactivity to nearest neighbors and battlefield interferents, stability, and physical specifications of

LFI strips. The contractor shall complete conformance testing and provide to the COR a Conformance

Test Report (CTR) containing all test results for a given lot and a certificate of compliance within 10 business days of receipt of test samples..

2.2.1.2 Stability Testing of LFIs (CLIN 0002). The contractor shall perform stability testing on LFIs that adheres to the COR provided most recent version of the DBPAO Stability Test Plan for LFIs.

The Contractor is not required to provide a certificate of compliance for stability tests, but the

Contractor shall provide stability summary reports on a quarterly basis.

2.2.2 Qualification and Stability Testing of ECL Immunoassays

2.2.2.1 Qualification Testing of Lot of Single Plex Plates for ECL Immunoassays (CLIN 0003). The contractor shall adhere to and maintain the COR provided, most recent version of the DBPAO

Conformance Test Plan (CTP) for ECL PR2 assays that outlines the acceptance test criteria and

DBPAO provided procedures for Meso Scale Diagnostics LLC ECL PR2 Assays. The contractor shall perform conformance tests on Meso Scale Diagnostics LLC ECL PR2 assays such as sensitivity, false positive reactions, dose response curves, and stability. The contractor shall complete conformance testing and provide to the COR a CTR containing all test results for a given lot and a certificate of compliance within 10 business days of receipt of test samples.

2.2.2.2 Stability Testing of Lot of Single Plex Plates for ECL Immunoassays (CLIN 0004). The contractor shall perform stability testing on single plex ECL immunoassay plates that adheres to the

COR provided most recent version of the DBPAO Stability Test Plan for ECL PR2 assays. The

Contractor is not required to provide a certificate of compliance for stability tests, but the Contractor shall provide stability summary reports on a quarterly basis.

2.2.2.3 Qualification of Testing of Lot of Multi-Plex Plates for ECL Immunoassays (CLIN 0005). The contractor shall adhere to and maintain the COR provided, most recent version of the DBPAO

Conformance Test Plan (CTP) for ECL PR2 assays that outlines the acceptance test criteria and

DBPAO provided procedures for Meso Scale Diagnostics LLC ECL PR2 Assays. The contractor shall perform conformance tests on Meso Scale Diagnostics LLC ECL PR2 assays such as sensitivity, false positive reactions, dose response curves, and stability. The contractor shall complete conformance testing and provide to the COR a CTR containing all test results for a given lot and a certificate of compliance within 10 business days of receipt of test samples.

2.2.2.4 Stability Testing of Lot of Multi-Plex Plates for ECL Immunoassays (CLIN 0006). The contractor shall perform stability testing on multiplex ECL immunoassay plates that adheres to the

COR provided most recent version of the DBPAO Stability Test Plan for ECL PR2 assays. The

Contractor is not required to provide a certificate of compliance for stability tests, but the Contractor shall provide stability summary reports on a quarterly basis.

2.2.3 Qualification and Stability Testing of ECL positive controls

2.2.3.1 Qualification Testing of Lot of ECL Positive Controls for Singleplex and Multi-Plex Plates

(CLIN 0007). The contractor shall adhere to and maintain the COR provided, DBPAO CTP for ECL positive controls that outlines the test criteria and procedures for ECL positive controls. The contractor shall perform sensitivity and stability testing on ECL positive controls to verify controls perform within acceptable ranges based on conformance criteria.

The contractor shall complete conformance testing within 10 business days of receipt of test samples and provide to the COR a CTR containing all test results for a given lot as well as a certificate of compliance within this same time period.

2.2.3.2 Stability Testing of Lot of ECL Positive Controls (CLIN 0008). The contractor shall perform stability testing lot of ECL positive controls that adheres to the COR provided most recent version of the DBPAO Stability Test Plan for ECL positive controls. The Contractor is not required to provide a certificate of compliance for stability tests, but the Contractor shall provide stability summary reports on a quarterly basis.

2.3 Quality control (applies to CLINs 0001-0008)

2.3.1 SOP for Inspection of GFM

The contractor shall have and maintain a contractor developed, COR approved, detailed SOP for inspection of GFM such as: HHAs, JBPDS/JPS carriers, ECL assays, ECL, and ECL positive controls, to assure that items were shipped in accordance with SOPs with regard to temperature, labeling, and packaging requirements. The contractor shall provide results of inspections in the CTR to the COR.

The contractor shall account for and retain all rejected material from receipt inspection until otherwise directed by the COR.

2.3.2 SOP for HHA and JBPDS/JPS Carrier Testing

The contractor shall have and maintain a contractor developed, COR approved, detailed SOP to ensure that all conformance testing of HHAs adheres to the DBPAO CTP and Government specifications and that the SOP for non-routine testing of JBPDS/JPS carriers is performed following the conformance test protocols. The SOP shall outline quality control procedures to ensure proper testing of HHAs and

JBPDS/JPS carriers and include procedures to identify physical flaws in HHAs that preclude testing reliability. This SOP shall include procedures to identify technical errors (i.e., technician or equipment errors) throughout each testing process (i.e., sensitivity, false positives etc.) that may lead to rejection of an acceptable HHA lot or acceptance of a lot that should be rejected. The SOP shall include quality control procedures to ensure that each lot number is correctly identified and recorded at each testing process.

2.3.3 SOP for ECL Testing

The contractor shall have and maintain a contractor developed, detailed SOP to ensure that all conformance testing adheres to the DBPAO CTP furnished as GFI for ECL assays and positive control.

The contractor shall ensure that the test results are evaluated against the technical criteria outlined in the DBPAO CTP in order to recommend whether a given lot of ECL assays should be accepted or rejected. The contractor’s SOP shall outline quality control procedures to ensure proper testing of ECL assays and positive controls. This SOP shall include procedures to identify physical flaws in ECL assays and positive controls that preclude testing reliability. This SOP shall include procedures to identify technical errors (i.e., technician or equipment errors) throughout each testing process (i.e., sensitivity, false positives) that may lead to rejection of acceptable lots or acceptance of lots that should be rejected. The

SOP shall include quality control procedures to ensure that each lot number is correctly identified and recorded at each testing process.

2.4 Change Requests (applies to CLINs 0001-0008) (A004)

2.4.1 The Contractor shall submit change requests for the following situations: changes in customer requirements, discovery by Contractor that there is a need to deviate from the CTP or other COR provided procedures/SOPs, obsolescence of current capabilities. The Contractor shall prepare and submit Requests for

Deviation (RFD), Specification Change Notices (SCN) or Engineering Change Proposals (ECP) for proposed changes to Government-controlled documents. The Government will notify the contractor five (5) business days prior to the scheduled change review (Government Configuration Control Board). The contractor shall present, via teleconference or in person at the Government site, the proposed changes and address all Government comments. The contractor shall not implement engineering changes or deviations which affect Government controlled documents without prior Government approval. The Government will maintain formal configuration control of all Government Furnished Technical Data such as DBPAO CTPs and Quality Assurance Procedures.

2.4.2 The contractor is responsible for assuring that any contractor change does not adversely affect conformance testing of HHAs and ECL assays, system reagents and positive controls.

2.5 Trend Analysis (CLIN 0010) (A005)

The contractor shall conduct trend analysis of QA/QC data and special studies related to QA/QC analysis as directed by the COR. The Contractor shall provide reports to the COR within 10 business days of analysis completion.

2.6 Performance (Progress) Reports (CLIN 0011) (A006)

The contractor shall submit monthly progress reports for work performed under delivery order to include the following: verification testing and stability testing data; program management and quality management updates; results of inspection of GFM for the reporting period; cumulative data as of report date; cost incurred for reporting period and total contractual expenditures as of report date; description of progress made during the reporting period including problem areas encountered and any recommendations for subsequent solutions beyond the scope of this PWS; plans for the following reporting period.

The first progress report shall contain a baseline GFM report that includes product, quantities, and locations. Updated GFM reports shall be available upon request.

2.7 Final Comprehensive Report (CLIN 0014) (A007)

The contractor shall submit a final comprehensive report within 60 days prior to the end of contract period of performance. The final comprehensive report shall include: summary of results of conformance testing, stability testing, and qualification testing performed on all DBPAO products under this PWS; total cost incurred for the entire performance work statement period and total contractual work expenditures;

description of all progress made including problems encountered and final recommendations for solutions;

final inventory of GFM.

2.8 Program Management (CLINs 0001-0008)

The program management objective is to allow the contractor the maximum flexibility to innovatively manage the program schedule, performance, quality, risk, subcontracts, and data to perform conformance testing that meets the requirements. Another objective is to maintain clear COR visibility into the program schedule, performance, and risk.

2.8.1 The contractor shall review documentation and provide input at a kickoff meeting (provide meeting minutes (CLIN0012) A006) and a yearly program review (provide meeting minutes (CLIN0013) A006).

Meetings are held at the DBPAO office, contractor site or via teleconference, as deemed appropriate by the

Government.

2.8.2 Program Management Plan (PMP) (CLIN 0015) (A008)

The Contractor shall have and maintain a COR approved PMP to reflect the contractor’s overarching approach to managing all aspects of the contract. The PMP shall include plans for data management, configuration management, quality assurance, and risk management. The contractor shall use established commercial practices to evaluate performance, schedule risks, and manage all aspects of the contract including interactions with the Government and management of subcontractors. The contractor shall maintain a detailed timeline to include ongoing and projected conformance testing requirements. The contractor shall submit a PMP that is integrated with all aspects of the program and conformance testing for COR approval. The contractor shall implement and maintain the COR- approved PMP throughout the life of the contract.

Individual plans for data management, configuration management, quality assurance, and risk management are not required if sufficient evidence is provided to and approved by the COR that procedure for data management, configuration management, quality assurance, and risk management have been incorporated into a Quality Management System (QMS) that meets ISO/IEC 17025 requirements (or equivalent).

2.8.2.1 Data management shall include procedures on:

Management of data generated from conformance testing

Inventories of GFM (baseline inventory will be verified by the COR), HHAs, ECL assays, ECL positive controls, and test antigens

Quality control procedures that ensure data integrity, data security and controlled access to data.

Data generated shall be included in the monthly status reports

2.8.2.2 Configuration management shall include procedures on control of all technical documents such as contractor SOPs, receipt inspection documentations, and data recording templates and should ensure continuous form, fit, and function.

2.8.2.3 Quality assurance procedures shall include:

Conformance testing SOP(s) that adhere to the DBPAO CTPs as described in paragraph 2.2 of this

PWS

SOP(s) for destruction of products and/or wastes consistent with DBPAO-provided guidelines and applicable Federal, State and local regulations

SOP(s) for handling customer satisfaction data provided by the Government

The contractor shall allow access to facilities, records, files, and other data derived from this work for the purposes of auditing the conformance test processes and QMS by the COR Government or its designee.

2.8.2.4 Risk management procedures shall reflect the contractor’s processes and procedures to identify, monitor, and mitigate all program risks.

3.0 DELIVERABLES - Department of Defense Form 1423-1 (Contract Data

Requirements List (CDRLs) as follows;

(Any reports resulting from this contract shall contain the following disclaimer statement on the cover of such reports:

“The views, opinion and findings contained in this report are those of the author(s) and should not be construed as an official Department of Defense position, policy, or decision, unless so designated by other official documentation.”)

3.1 PMP (A008): Submit for Government approval within 90 days of contract award, to: Bruce

Goodwin, SFAE-CBRND-JPMG-DBPAO, 110 Thomas Johnson Drive, Suite 240, Frederick, MD

21702.

3.2 Conformance Test Reports (CTR) and certificates of compliance (A001): Submit to Government within 10 business days of receipt of samples and testing completion for HHA, ECL assays, and ECL positive controls.

3.3 Stability Testing Summary Reports (A002): Submit to Government quarterly summary reports of

LFI stability testing, ECL assay stability testing, and ECL positive control stability testing.

3.4 General Incident Report (A003): Submit incident report to the Government within three (3) business days of occurrence of an incident and include incident description, contractor actions taken, and contractor recommendations.

3.5 Change Requests (A004): Submit change requests (RFD, SCN, or ECP) for changes in customer requirements, when Contractor discovers need to deviate from CTP or other COR-provided procedures/SOPs, or obsolescence of current capabilities.

3.6 Trend Analysis Reports (A005): Submit to Government within 10 business days of conclusion of any trend analysis or special study related to QA/QC analysis.

3.7 Progress Reports (A006): Submit to the Government on the 10th of each month.

3.8 Final Comprehensive Report (A007): Submit Final Comprehensive report within 60 days prior to the end of contract period of performance.

DI-MGMT-80227 Contractor’s Progress, Status and Management Report

CDRLs - FY18 CTL DIDs

A001 – Conformance Test Report (CTR) and Certification of Compliance DI-MGMT-80227

A002 – Stability Summary Report DI-MGMT-80227

A003 – General Incident Report DI-MGMT-80227

A004 – Change Requests DI-MGMT-80227

A005 – Trend Analysis Report DI-MGMT-80227

A006 – Progress Report DI-MGMT-80227

A007 – Final Comprehensive Report DI-MGMT-80227

3.9 – Report Deliverables Schedule

PWS

Deliverable

Due Date

# of copies

Format/Media

Submit

To

2.8.1

Kickoff Meeting Minutes

Report (A006)

Included with monthly

Performance (Progress) report

1x

Electronic

(Microsoft

Office format or

PDF)

COR,

Gov’t

Lead

2.2.1, 2.2.2, 2.2.3

Conformance Test Reports

(CTR) and Certificates of

Compliance (A001)

Within 10 business days from receipt of test samples

(Microsoft

Office format or

PDF)

COR,

Gov’t

Lead

2.2.1, 2.2.2, 2.2.3

Stability Testing Summary

Reports (A002)

Quarterly

(Microsoft

Office format or

PDF)

COR,

Gov’t

Lead

2.1.6

General Incident Report

(A003)

Telephonically within 24 hours of incident. Written report within three (3) business days of incident.

(Microsoft

Office format or

PDF)

COR,

2.4

Change Requests (A004)

Gov’t comments or approval

15 days post receipt

(Microsoft

Office format or

PDF)

COR,

2.5

Trend Analysis Report (A005)

Within 10 business days of trend analysis or special study completion

(Microsoft

Office format or

PDF)

COR,

2.6

Performance (Progress)

Report (A006)

10th of each month

(Microsoft

Office format or

PDF)

COR,

2.7

Final Comprehensive Report

(A007)

Within 60 days prior to the end of contract period of performance.

(Microsoft

Office format or

PDF)

COR,

2.8.2

Program Management Plan

(A008)

Within 90 days of contract award

(Microsoft

Office format or

PDF)

COR,

4.0 FACILITIES

The contractor shall provide the requisite facilities that adhere to applicable Federal, State and local regulations required to perform the activities herein including the handling and destruction of GFM and associated materials.

5.0 TRAVEL (CLIN 0009)

Travel will be authorized for meeting attendance (see section 2.8.1) and on an as needed basis. The contractor has no authority to incur travel costs without explicit written approval (email acceptable) of the Contracting Officer Representative (COR).

6.0 SECURITY

Certain aspects of the work under this PWS are considered classified or proprietary. The Contractor shall comply with the security requirements listed in the Department of Defense Contract Security

Classification Specification (DD254) and the DBPAO Security Classification Guide (Attachment A).

The Contractor shall possess a current Department of Defense SECRET level facility clearance with

SECRET Safeguarding. Contractor’s personnel who will perform work under this PWS and will have access to GFI will be required to have a DoD SECRET level clearance and sign a non-disclosure agreement (Attachment B). The Contractor shall provide secure storage for all

Government Furnished materials, documents, information, data (hard copy and/or digital format) and restrict access to GFIs to Contractor’s employees who will perform work under this PWS.

Attachment E – Government Furnished Equipment Maintenance, Warranty and Service Contracts

The following GFE require annual service contracts. These service contracts are priced in total as a month rate in a separate CLIN - 0016.

GFE Serial No. Model

Meso-Scale PR2 System 18001405010303 PR2-1800

Meso-Scale PR2 System 18001405010306 PR2-1800

Bio-Plex Luminex System 14311704 MAGPIX XMAP

Bio-Plex Luminex System 15107703 MAGPIX XMAP

Plate Washer, Bio-Rad 1504003904 Bio-Plex Pro

Plate Washer, Bio-Rad 1504003905 Bio-Plex Pro

Plate Washer, Bio-Tek 140325B 405LS

Plate Washer, Bio-Tek 1403253 405LS

Other GFE that do not require service contracts but require calibration or periodic service by the contractor in order to maintain functionality:

GFE Serial No. Model

Precision Balance 90708379 BP615

Calipers (Mitutoyo) none none

Traceable calipers 150699553 Control Co.

CAMAG TLC Scanner 3 050521 TLC3

CAMAG TLC Scanner 3 090225 TLC3

Ultrasonic cleaner QGA02157082A P4820

Vacusip 140093 VACUSIP

Vacusip 140118 VACUSIP