Attachment 1 Performance Work Statement 12805B24Q0647.pdf

United States Department of Agriculture Agricultural Research Service

PERFORMANCE WORK STATEMENT

PROJECT: GMP QUALITY CONSULTANT(S)

National Bio and Agro-Defense Facility USDA-ARS, Manhattan, KS

Contents

1. PURPOSE

2. MISSION AND BACKGROUND

3. PERIOD AND LOCATION OF PERFORMANCE

4. CONTRACTOR PERSONNEL

5. GOVERNMENT PERSONNEL

6. PERFORMANCE REQUIREMENTS

7. OPERATING CONTRAINTS AND ANY ADDITIONAL REQUIREMENTS

8. QUALITY ASSURANCE SURVEILLANCE PLAN

1. PURPOSE

This Performance Work Statement for procuring a GMP quality consultant(s) will describe the work in terms of the required results and enable assessment of work performance against measurable performance standards. The quality consultant(s) will be operating and providing services at the National Bio and

Agro-Defense Facility (NBAF) in Manhattan, Kansas.

Acronyms Summary:

ARS: Agricultural Research Services

BDM: Biological Development Module

CFR: Code of Federal Regulations

CO: Contracting Officer

COR: Contracting Officer’s Representative

CUI: Controlled Unclassified Information

FAR: Federal Acquisition Regulation

ISO: International Organization for Standardization

NBAF: National Bio and Agro-Defense Facility

NDA: Non-Disclosure Agreement

POP: Period of Performance

PRS: Performance Requirements Summary

PWS: Performance Work Statement

QA: Quality Assurance

QASP: Quality Assurance Surveillance Plan

SQP: Site Quality Plan

USDA: United States Department of Agriculture

2. MISSION AND BACKGROUND

The NBAF provides and strengthens the nation with critical capabilities to diagnose animal diseases, to conduct research and develop vaccines and other countermeasures, and to train veterinarians and other scientists in preparedness and response to disease outbreaks. NBAF’s mission is to protect the United

States against transboundary, emerging, and zoonotic animal diseases that threaten our food supply, agricultural economy, and public health. NBAF’s vision is to create a safer and more resilient America through a world-class science facility for large animal agricultural research, training, and diagnostics.

The mission of the Biologics Development Module (BDM) within the NBAF is to directly support and accelerate technology transfer of vaccines, diagnostics, biotherapeutics, and other veterinary medical countermeasures for development to commercial veterinary biologic manufacturers and other partners.

BDM efforts include, but are not limited to, the production of attenuated viral and bacterial master seeds, master cells for viral vaccine production, monoclonal antibodies, small scale viral and bacterial

(attenuated or inactivated) vaccines, recombinant proteins, and diagnostic reagents. The BDM also provides dedicated space for formulation manufacture of experimental products for clinical studies, support the early development of veterinary medical countermeasures, implementation of quality assurance and quality control measures, and support the technology transfer to potential future commercial manufacturers. It is through these efforts and provisions, that the BDM envisions putting impactful biologics solutions into the hands of farmers, producers, and veterinarians through a focus on quality and collaboration with cutting-edge science institutions and biologics manufacturers.

3. SCOPE

To accomplish this vision and mission the BDM will need assistance in providing a comprehensive quality system and has defined the need for a quality consultant(s) specific to Good Manufacturing

Practices and other specified regulatory requirements and advisement. The primary contractor and identified consultant(s) will provide expertise and support for qualifications, validations, regulatory oversight, certifications, and procedures for products at various developmental stages, equipment, and laboratory spaces within the BDM.

The primary contractor and identified consultant(s) will be required to advise and consult on all stages of product development relevant to the BDM, such as early research and development, upscaling and continued development, and final transfer of the product to other industry partners. The primary contractor and identified consultant(s) will provide experienced and direct guidance to the quality team and director/supervisor within the BDM for Title 21 of the Code of Federal Regulations (CFR) and The

European Medicines Agency (EMA) EudraLex in relation to Good Manufacturing Practices (GMP) objectives. In addition to the above regulation guidance, the primary contractor and identified consultant(s) will ensure the BDM adheres to Title 9 of the Code of Federal Regulations within interactions with the Center for Veterinary Biologics (CVB). While all of the regulations overlap it will be important to ensure they are still addressed individually when required and incorporated together successfully. The BDM does not plan to be accredited or audited to the CFR, EMA, GMP standards at this time, however it is the BDM’s goal to strive for these standards and outlined requirements.

Objectives to be met by the primary contractor and identified consultant(s) are listed in further detail in

Performance Requirements Summary (PRS).

As mentioned, the BDM is part of the NBAF, as an organization, NBAF, will be working towards accreditation with the ISO 9001: 2015 Quality Management Systems standard. It is expected of the primary contractor and identified consultant(s) that any changes, implementations, documents created or identified will incorporate effectively with this ISO standard.

The BDM also maintains a Quality Specialist position to support the quality initiatives discussed. This

Quality Specialist is trained, experienced, and responsible for early implementation of these systems, however guidance, coordination, teaching, and briefing from an experienced consultant will be utilized to bridge the gap between understanding and true implementation. It is expected of the primary contractor and identified consultant(s) to communicate regularly and effectively with the Contracting Officer

Representative (COR), BDM unit including the Director/Supervisor, and the BDM Quality Specialist.

The end goal of procuring the quality consultant(s) will be quality system implementations, regulatory understanding, clear process outlines, and documentation for the applicable equipment, product, and work streams to allow for standardized commercial scaling operations. As well as assistance with effective, documented, and organized process transfer to partnered production facilities.

4. PERIOD AND LOCATION OF PERFORMANCE

The base period of performance (POP) must be for one (1) Base Year of 12 months and two (2) Option

Years of 12 months at the NBAF located at 1980 Denison Ave. Manhattan, LS 66502.

The identified consultant(s) will be expected to carry out quarterly onsite visits to meet objectives and goals throughout the year, be available for scheduled bi-weekly meetings with identified personnel and reply to phone calls/emails within a 7-day timeframe, unless otherwise communicated and justified ahead of time.

The work must be scheduled during normal business hours of the NBAF between 7:00 am and 5:00 pm local time; Monday – Friday. Work completed after hours or on weekends and/or holidays will be proposed at least a week in advance of the requested work time and may coordinated and reviewed in conjunction with the Contracting Officer/Contracting Officer’s Representative.

Federally Observed Holidays:

New Year’s Day

Martin Luther King’s Birthday

Washington’s Birthday

Memorial Day

Juneteenth National Independence Day

Independence Day

Labor Day

Columbus Day

Veterans’ Day

Thanksgiving Day

Christmas Day

5. CONTRACTOR PERSONNEL

Qualifications:

The primary contractor must provide documentation showing the consultant(s) performing work under this

PWS have certified training and documented experience in various quality systems and scaling operations in a regulatory environment.

The consultant(s) must have 10 or more years of experience directly related to consulting for various quality systems to include implementing a quality management system, leading audits, regulatory affairs/interaction, overseeing/managing quality implementations, and compliance with multiple standards to include Title 21 of the Code of Federal Regulations (CFR), The European Medicines Agency (EMA)

EudraLex in relation to Good Manufacturing Practices (GMP), and ISO 9001:2015 Quality Management

Systems.

Identification:

All contract personnel attending meetings, answering government telephones, and working in other situations where their contractor status is not obvious to third parties are required to identify themselves as such to avoid creating an impression in the minds of members of the public that they are

USDA/government officials. They must also ensure that all documents or reports produced by contractors are suitably marked as contractor products or that contractor participation is appropriately disclosed.

For NBAF Facility security purposes, the contractor must provide the CO a list of all employees who will perform work under this contract. The list must include name and work assignment of each employee.

The contractor must maintain revisions and updates to this list and submit them to the COR monthly as needed. The contractor must furnish each employee a contract identification badge that must be conspicuously displayed when working. The ID badge must include the full name of the employee, company name, a badge serial number.

Conduct:

The CO may require the contractor to remove any employee(s) from the contract and worksite for nonperformance, misconduct, or failure to abide by all laws and regulations. The contractor must immediately comply with these requests. The following is not an all-inclusive list of conduct expectations:

1. There must be no fraternization or interference with the work of employees at the NBAF.

2. There must be no violation of the GSA Publication; Rules and Regulations Governing Conduct on Federal Property (Federal Management Regulation Title 41, Code of Federal Regulations, Part

102-74, Sub-Part C, November 2005).

3. contractor personnel’s conduct must not reflect discredit upon USDA-ARS.

4. The contractor must ensure that personnel present a professional appearance.

5. The contractor’s employees must observe and comply with all NBAF and local policies and procedures concerning fire, safety, environmental protection, sanitation, security, and possession of firearms or other lethal or illegal weapons or substance. The contractor is responsible for ensuring that any contractor employees or subcontractor providing services under this contract conduct themselves and perform services in a professional, safe, and responsible manner.

6. The contractor must remove from the job site any employee or subcontractor for reasons of misconduct or security.

7. Neglect of Duties - includes sleeping on duty, failure to be attentive to assigned duties, failure to carry out assigned tasks, conducting personal business during duty hours.

8. Disorderly Conduct - e.g., the use of abusive or offensive language, quarreling, intimidation by words, actions, fighting, or participation in disruptive activities which interfere with normal and efficient operations of the NBAF or any organization or function on the NBAF Campus.

9. Criminal Actions - e.g., falsification or unlawful concealment, removal, mutilation, or destruction of any official documents, reports, or records, unauthorized use of government property, theft, vandalism, immoral conduct, organizing or participating in gambling of any form, unethical, improper, or fraudulent use of official authority or identification, the unauthorized, improper, or fraudulent use of communications equipment.

10. Release of Information - all contractor employees must be prohibited from releasing any information pertaining to duty assignments, manpower, personnel, or other information to any outside organization or person(s), without the explicit, written consent of the CO or COR.

11. Violations of Security Procedures or Regulations - includes violations of established security procedures, policies, regulations, or guidelines, as well as failure to report to appropriate security officials any unauthorized security activity, observed or otherwise known to have occurred, or which is about to occur, on or which could affect USDA, APHIS, ARS, any specific organization or mission within USDA, or the security posture of the NBAF.

12. Particular attention should be paid to acceptance of gifts/ gratuities, and on non-disclosure of sensitive or classified information.

13. The contractor must ensure employee or subcontractor conduct complies with 41 USC 423 relative to release of acquisition related information, or actions or discussions which may prejudice future competitions.

14. The contractor must ensure no contractor employees conduct political related activities or events on the Installation.

Furnished Items and Responsibilities:

The contractor must furnish all personnel, equipment, materials, supplies, services, and shipping costs required to achieve the performance requirements of the work in this contract, unless otherwise specified herein. The certifying engineer/technician performing work under this contract must safeguard all USDA-

ARS equipment, information and property provided for contractor use. At the close of each work period, USDA-ARS facilities, equipment, and materials must be secured.

The contractor must provide a plan for the completion of the work outlined in this PWS and submit to the

COR at a minimum of seven days (7) prior the start of work.

Conference / Performance Evaluation Meetings:

The contractor agrees to attend any post award conference convened by the contracting activity or contract administration office in accordance with FAR Subpart 42.5. The CO and COR must have performance evaluation meetings with the contractor to review the contractor's performance as needed. At these meetings the CO will apprise the contractor of how the government views the contractor's performance and the contractor will apprise USDA-ARS of problems, if any, being experienced.

Appropriate action must be taken to resolve outstanding issues. Meetings may be held at any time thereafter.

6. GOVERNMENT PERSONNEL

Provisions:

1. The government must provide access to the spaces and equipment in need of regulatory oversight.

2. The government will work with the contractor to provide applicable and appropriate documented information for regulatory oversight, review, feedback, and creation.

3. The government will provide documentation to confirm that the laboratory spaces have not been exposed to biological hazards or have been properly decontaminated and do not pose human exposure risk.

4. The government will provide escorts for necessary contractor personnel when onsite.

5. The government will provide training onsite for emergency procedures such as weather, fire, and any necessary biosafety practices that must be adhered to, as needed.

6. The government will provide collaboration from the NBAF Quality Assurance Team as needed or required.

Contracting Officer’s Representative (COR):

The COR monitors all technical aspects of the contract and assists in contract administration The COR is authorized to perform the following functions: Assure that the contractor performs the technical requirements of the contract; perform inspections necessary in connection with contract performance;

maintain written and oral communications with the contractor concerning technical aspects of the contract; issue written interpretations of technical requirements, including government drawings, designs, and specifications; monitor contractor's performance and notifies both the CO and contractor of any deficiencies; coordinate availability of government furnished property, and provide site entry of contractor personnel. The COR is not authorized to change any of the terms and conditions of the resulting order.

6. PERFORMANCE REQUIREMENTS

1. All services must meet all Local, State and Federal codes.

2. The contractor shall work with USDA personnel to ensure project is accomplished in a timely manner.

3. The contractor must perform work in accordance with NBAF’s safety and quality standards.

4. The contractor must perform work in accordance with the manufacturer's specifications for all equipment within the BDM.

5. The contractor must review/provide feedback/developmental changes to the following BDM

Quality Documents to ensure forward movement to GMP standards.

a. Quality Policy

b. Quality Plan

c. Quality Manual

6. The contractor shall develop and provide equipment and process qualification protocols.

7. The contractor shall become familiar with the deviation investigation process at NBAF and provide GMP oversight that can be successfully integrated within the system, as well as assist with any set up of the initial investigational processes based on when the contract is awarded.

8. The contractor shall develop and provide suggested cleaning, clearance, and equipment standard operation procedures.

9. The contractor shall provide a recommended batch record form/template for product production, and/or integrate a batch record format into one of the information systems within NBAF.

10. The contractor shall assist in developing training protocols, procedures, and requirements and integrating them within the established documentation and training systems at NBAF.

11. The contractor shall collaborate with the BDM scientific and quality personnel to develop a validation program for equipment and products. This includes defining the process, assisting with validation, and/or recording validational activities based on guidance and needs.

12. The contractor shall provide guidance, assistance, and participation in any internal audits carried out or planned during the life of the contract as necessary.

13. The contractor must provide a cGMP compliant formal report to include results, discussion, and enumeration of all created documentation and improvements made throughout the life of the contract.

14. The contractor agrees to discuss any issues or actions that need improvement with the government and provide feedback or improvements as needed.

7. OPERATING CONTRAINTS AND ANY ADDITIONAL REQUIREMENTS

Security Requirements:

Personnel employed by the contractor or any representative of, or agent of the contractor, entering this facility must conform to the facility security regulations. The contractor must provide all information required for background checks to meet facility access requirements as performed by the facility security office. contractor personnel must comply with all personal identity verification requirements as directed by USDA-ARS Security office. Each person accessing the site will be required to provide personal details, (full name, DOB, SSN, DL#) and will undergo a routine background check, such as a National

Agency Check with additional inquiries, which may include a criminal and credit check. Details required for the check should be submitted the security office no later than 5 days prior to the visit. Results of this check may return earlier; however, it should not be planned to have results earlier than 5 days. If, while on site the contractor/vendor will have access to sensitive information, they must complete a Non-

Disclosure Agreement, along with the required training. This training will most likely be completed by reviewing a series of slides covering the topics of the definition of controlled unclassified information

(CUI), access, handling, distribution, storage, and destruction of CUI. Each person will acknowledge receiving and understanding the training on the NDA. The process should not exceed two hours.

Acknowledgement and completion of the NDA will be turned in with the form required for the background check. Results will be returned through the Contracting Officer or Contracting Officer

Representative.

The contractor and/or any representative of, or agent of the contractor, entering this facility must conform to the visitor and escorting policies. All visitors must displaying appropriate badge and/or other identifying credentials. All visitor(s) have their government issued photo I.D. or equivalent, in addition to, NBAF issued visitor badge available for upon request by security personnel while on the NBAF. Visitors must sign applicable visitor log upon entrance and exit and stay with the escort at all times. The contractor and/or any representative of, or agent of the contractor must not take photography of the interior or exterior of the NBAF from within the NBAF property. The contractor and/or any representative of, or agent of the contractor, entering this facility must comply with all USDA and NBAF procedures and/or policies (e.g., Rules and Regulations Governing Conduct on Federal Property Title 41

CFR Part 102) and submit to searches by security personnel of their person, personal effects, and vehicles as per 41 CFR 102-74.370.

8. QUALITY ASSURANCE SURVEILLANCE PLAN

This Quality Assurance Surveillance Plan (QASP) is a government developed and applied document used to provide a standard of surveillance for monitoring a GMP quality consultant(s) contract. This QASP establishes the approach the government will use to conduct surveillance of the contractor’s quality control. The intent is to ensure that the contractor performs in accordance with performance requirements set forth in the contract documents, that the government receives the quality of services called for in the contract, and that the government only pays for the acceptable level of services received.

The contractor is responsible for management and quality control actions to meet the terms of the contract. The role of the government’s quality assurance (QA) representative (BDM Quality Specialist) is to ensure the contractor performs quality control to adequately meet contract standards. USDA-ARS performance assessments will be assigned to and authorized by the COR. The COR will evaluate the contractor's performance under the Quality Assurance Surveillance Plan (QASP).

From the start of the contract, all contractor operational procedures and quality assurance measures will be tested and implemented. As the performance period progresses, the levels of surveillance may be altered for service areas in cases where performance is either consistently excellent or consistently unsatisfactory. If observations reveal consistently good performance, then the amount of surveillance may be reduced. If observations reveal consistent deficiencies, increased surveillance may be implemented.

Although USDA-ARS may develop a Quality Assurance Surveillance Plan, USDA-ARS surveillance of contractor performance is not limited to the QASP or the performance objectives, incentives/remedies, etc. USDA-ARS has the right to inspect and test all services called for by the contract and commitments made by the contractor during the solicitation process, to the extent practicable at all places and times during the term of the contract. USDA-ARS will perform inspections and tests in a manner that will not unduly delay the work. If any of the services performed do not conform to contract requirements, USDA-

ARS may require the contractor to perform the services again in conformity with contract requirements, at no increase in contract amount. When the defects in services cannot be corrected by re-performance, USDA-ARS may: (1) require the contractor to take necessary action to ensure that future performance conform to contract requirements and (2) reduce the contract price to reflect the reduced value of the services performed. If the contractor fails to promptly perform the services again or take the action necessary to ensure future performance in conformity with contract requirements, USDA-ARS may: (1) by contract or otherwise, perform the services and charge to the contractor any cost incurred by USDA-

ARS that is directly related to the performance of such service, or (2) terminate the contract for default.

"Services", as used in this clause, includes services performed, workmanship, and material furnished or used in performing services.

The contractor’s routine performance is evaluated objectively against the performance-based standards provided in the PWS. The basis of performance-based contracting allows for some flexibility in enforcement to encourage innovation by the contractor in achieving the desired results. The government has the right to inspect and test all services called for in the contract. When services are deficient and cannot be re-performed satisfactorily by the contractor, the government will refer to the Inspection of

Services clause for remediation.

Methods of Inspection:

The below listed methods of surveillance may be used in the administration of this QASP. They can occur quarterly, monthly, or as needed:

1. 100% Inspection

a. The COR may conduct 100% inspections of the work defined in the PWS. The COR will also review information submitted in the required reports defined in the PWS (if applicable).

2. Periodic Inspection

a. The government may conduct periodic inspections monthly, quarterly, or on an as-needed basis. The periodic inspection shall be conducted by the COR.

3. Random Inspection

a. The government may conduct random monitoring by reviewing information/reports required and submitted in accordance with the contract. The random monitoring shall be performed by the COR.

4. Performance Evaluation Meetings

a. The contractor and the COR will meet as often as necessary to review the contractor’s performance and address any discrepancies that have been noted during the period of performance. A mutual effort will be made to resolve identified issues.

5. Personnel Feedback

a. The COR may provide and collect BDM personnel surveys or complaints regarding performance. A mutual effort will be made to resolve any problems/issues identified.

Level of surveillance may be conducted on a monthly, quarterly, or as-needed basis and an analysis of the results will determine if the contractor met the standards or did not met the standards identified in the

PWS/contract.

Performance Requirements Summary (PRS):

Performance Objective Acceptable Quality Level Method of

Inspection

All services must meet all Local, State and Federal codes.

0 codes Local, State and Federal codes broken during the period of performance and utilized option years.

100%

Inspection

The Contractor will work with

USDA personnel to ensure project is accomplished in a timely manner.

An initial timeline with milestones related to each objective will be developed initially by the contractor, in coordination with the BDM unit, and provided within 30 days of award.

This timeline should include plans for meeting all performance requirements within the initial contract (1-year), and action items to be followed up on, tracked, trended, during the options years.

Any deviations from this timeline will be properly documented and justified by both parties.

Periodic

Inspection

The contractor must perform work in accordance with NBAF’s safety and quality standards.

The contractor will attend provided visitor training and read and understand the BDM Visitor and Quality Policy as required.

This training will not exceed 4 hours in total.

Personnel

Feedback, and Periodic

Inspection

The contractor must perform work in accordance with the manufacturer's specifications for all equipment within the BDM.

Manufacturers specifications referenced, and any work done with equipment, will be defined, and shared with the BDM Quality Specialist.

Periodic

Inspection

The contractor must review/provide feedback/ developmental changes to the following BDM Quality

Documents to ensure forward movement to GMP standards.

The documents will be provided to the contractor, and comments/feedback/edits are provided by the contractor, in reference to required quality elements based on obtainable objectives during the time of the contract.

100%

Inspection

The contractor shall develop and provide equipment and process qualification protocols.

Provided protocols for methods demonstrating that the equipment/processes being used or implemented will offer a high degree of quality assurance such that production processes will consistently manufacture products that meet quality requirements. Depending on the equipment or process status an Installation, Operational, and/or Performance Qualification protocol would be expected.

Periodic

Inspection

The contractor shall become familiar with the deviation investigation process at NBAF and provide GMP oversight that can be successfully integrated within the

The contractor will collaborate with the BDM to propose a deviation investigation process that is prompt and effective that clearly and concisely demonstrates that the root cause of the deviation has been identified, corrective actions have been

Periodic

Inspection system, as well as assist with any set up of the initial investigational processes based on when the contract is awarded.

take, and that safety, integrity, potency, and purity of the product has been ensured. The proposal will include a reporting format that provides appropriate level of background and ensures the level of investigation balances with the identified level of risk and integrates within the establish information systems at NBAF as needed.

The contractor shall develop and provide suggested cleaning, clearance, and equipment standard operation procedures.

The contractor will work with the BDM personnel to define what equipment will be focused on. The contractor will ensure that any equipment defined, including dedicated and multipurpose equipment, has provided protocols that ensure it is cleaned, maintained, and as appropriate sanitized and/or sterilized at appropriate intervals to ensure quality of the product.

Periodic

Inspection

The contractor shall provide a recommended batch record form/template for product production, and/or integrate a batch record format into one of the information systems within NBAF.

A batch record form or template should be provided to the BDM unit and includes information like product name, weight, and count as needed. A list of all processes and procedures to follow and any expected yields should also be included. This form/template should be able to be followed with precision and understanding by the

BDM unit. Based on time of contract this might also be required to be integrated within the information systems already in place at NBAF.

100%

Inspection

The contractor shall assist in developing training protocols, procedures, and requirements and integrating them within the established documentation and training systems at NBAF.

The contractor will provide developed training protocols for identified gaps in procedures and assist the BDM Quality Specialist with the BDM training requirements program. In collaboration with the BDM this program will be successfully integrated into the established documentation and training systems at NBAF. The contractor will show participation and initiative in any workforce development initiatives, such as individualized training plans, that are ongoing at time of contract.

Personnel

Feedback, and Periodic

Inspection

The contractor shall collaborate with the BDM scientific and quality personnel to develop a validation program for equipment and products.

This could include defining the process, assisting with validation, and/or recording validational activities based on guidance and needs. A well-defined systematic approach to validation that involves establishing documented evidence and confirming consistency in meeting quality standards for both applicable equipment and processes is established and provided.

Personnel

Feedback, and Periodic

Inspection

The contractor shall provide guidance, assistance, and participation in any internal audits or inspections carried out or planned during the life of the

If an internal audit is carried out during the life of the contract the contractor is willing to participate informally or formally as time allows and provides insight for improvements and findings.

The contractor must support preparations for any

Personnel

Feedback, Performance

Evaluation Meetings, contract as necessary. Center for Veterinary Biologics (CVB) inspections that are scheduled or carried out during the length of the contract.

and Periodic

Inspection

The contractor must provide a cGMP compliant formal report to include results, discussion, and enumeration of all created documentation and improvements made throughout the life of the contract.

A formal report is provided at the end of the base year of the contract, and each additional option year as needed. The information must be provided as both a hardcopy and digital copy in a format to be determined by the government.

Periodic

Inspection

The contractor agrees to discuss any issues or actions that need improvement with the government and provide feedback or improvements as needed.

Communications are kept open and honest between the COR, CO, and contractor. Regular meetings are held depending on the nature and requirements of the contract.

Meeting requirements and frequency will be defined by the COR in coordination with the contractor within 30 days of awarding the contract and general expectations are detailed in section “4. Period And Location of Performance”.

At minimum weekly meetings will be held with the BDM Quality Consultant and Leadership to discuss objectives, projects, work, and recommendations.

Performance

Evaluation

Meetings

Effective contract surveillance relies on the COR identifying and documenting discrepancies during performance of routine daily services, or through the period of performance of the contract. The COR will report discrepancies to the contractor for timely resolution. Surveillance may consist of periodic reports, and customer feedback and timeliness of contract deliverables/reports. The COR will maintain a complete

QA file which will be retained by the COR for the life of the contract. Information in the QA file will be considered when completing the annual CPARS report.