Attachment 2 - Statement of Work (SOW).pdf

US Department of Agriculture (USDA)

Statement of Work

Contents Project

General Information

1.0 Scope of Work

2.0 Background

Contractor Requirements

3.0 Technical Requirements / Tasks

4.0 Government Furnished

5.0 Deliverables / Schedule

6.0 Travel

7.0 Contractor’s Key Personnel

8.0 Security Requirements

9.0 Data Rights

10.0 Section 508 – Electronic and Information Technology Standards

N/A

Attachment/Reference Documents

Project Certification, Maintenance, and Repair of Biological Safety Cabinets (BSC), Isolators, and Chemical Fume Hoods

General Information

1.0 Scope of Work

Perform quarterly certification, maintenance, and repair services for all BSCs, isolators, and chemical fume hoods located at The National Centers for Animal Health (NCAH) facilities including on an “as needed” basis according to the standards listed in this Statement of Work.

Service to include any and all costs associated with furnishing and delivering all materials and for performing all the work required in a complete and acceptable manner including but not limited to overhead, general and administrative costs, profit, personnel lab draw costs, certification, transportation costs, and required test equipment and calibration.

2.0 Background

The NCAH facilities located at 1920 Dayton Avenue, Ames, IA 50010, 1015 N. University Blvd, Ames, IA 50011, and 716 Farm House Lane, Ames, IA 50011 are ISO 17025 accredited and currently have Class I Laminar Air Flow BSCs, Class II BSCs, Class III BSCs, HEPA filtered small animal isolators, and chemical fume hoods. There are approximately 261 biosafety cabinets, 47 HEPA filtered small animal isolators, and 75 chemical fume hoods that require certification, maintenance, and repair.

Contractor Requirements

3.0 Technical Requirements / Tasks

3.1 The Contractor’s certifier must conduct site visits quarterly per the schedule in section 3.13 and a maximum of 10 emergency site-visits within the period of performance for the annual certifications of all BSCs, isolators, and chemical fume hoods and provide maintenance, repairs, and certifications on “as needed” basis according to the standards specified in this section.

The contractor must coordinate with the COR at least 2 weeks prior to the anticipated service date to ensure NCAH staff will be available to escort the certifying technician, answer questions, and provide data on the intended certification date(s).

Certification, maintenance, and repairs must take place during normal business hours, Monday through Friday 7:00 am - 4:30 pm, excluding federal holidays.

3.2 The Contractor must be accredited by the National Sanitation Foundation (NSF) on NSF/ANSI Standard 49 Class II (Laminar Flow) Biosafety Cabinetry, as required to be a certifier to certify and make repairs to BSCs.

The Contractor must submit a copy of the Certifier’s NSF Accreditation Certificate to the Contracting Officer’s Representative (COR) when the individual comes on-site.

3.3 All biological safety cabinet testing, repairs, and certifications must be performed in accordance with NSF/ANSI Standard 49 Class II (Laminar Flow) Biosafety Cabinetry, Annex F – Field Tests or according to manufacturer specifications and recommendations.

3.4 The Class I cabinets, Class III cabinets, and HEPA filtered small animal isolators must be certified according to manufacturer specifications and recommendations.

3.5 The chemical fume hoods repair and certifications must be performed in accordance with NFPA 45, ANSI Standard Z9.5, and ASHRAE 110 (excluding tracer gas studies), and fume hood manufacturer recommendations.

3.6 Decontamination associated with repairs, HEPA filter replacement, and decommissioning must be performed by the certifier in accordance with NSF/ANSI Standard 49 or manufacturer specifications and recommendations.

3.7 Any BSC, isolator, or fume hood that fails certification must be disabled by the certifier by placing tape or signage across the sash or unit until repairs, recertification, or decommissioning are completed.

3.8 Filter replacement and repairs to BSCs and HEPA filtered small animal isolators must meet NSF/manufacturer specifications.

3.9 For BSCs, HEPA filtered small animal isolators and fume hoods failing certification, part numbers for required repair parts must be submitted to the COR within 10 business days following the site visit. Filters, replacement, and repair parts will be provided by the NCAH and must be installed by the certifier during regularly scheduled visits and emergency visits.

3.10 The COR may at times determine that the cost and age of devices no longer warrant continued service; the certifier must then decommission it and remove it from service.

3.11 Certification stickers must be posted on all BSC, isolators, and fume hoods and signed certification reports must be submitted to the COR within 15 business days after certifications have been completed.

Certification stickers must display at least the following information: company name providing the certification, serial number of the fume hood, date certification testing was performed, duration of certification period, certification report identifier and the signature of the person performing the certification.

3.12 The following physical certification tests are the minimum required tests to be performed for BSCs:

Downflow Velocity Inflow Velocity HEPA Filter Leak Test (both supply and exhaust) Airflow Smoke Pattern Tests o Downflow Test o View Screen Retention Test o Work Opening Edge Retention Test o Sash/Window Seal Test

3.13 The Contractor must perform quarterly site visits according to the schedule below. The quantity of equipment and areas to be serviced is based on current estimates and is subject to change.

Quarter 1: All services must be completed no later than January 31st Areas: 2nd Floor North tower, 2nd Floor South tower, ISU equipment o Biological Safety Cabinet – Quantity 80 o Chemical Fume Hoods - Quantity 32

Quarter 2: All services must be completed no later than April 30th Areas: B20 All of first floor & B21 o Biological Safety Cabinet - Quantity 58 o Chemical Fume Hoods - Quantity 30

Quarter 3: S All services must be completed no later than July 31st Areas: B20 basement, 401, B20 vivarium, 3H, B9 o Biological Safety Cabinet - Quantity 64 o Chemical Fume Hoods - Quantity 4 o Small Animal Isolator - Quantity 47

Quarter 4: All services must be completed no later than October 31st Areas: 3rd Floor South tower-DVL, 3rd Floor North tower o Biological Safety Cabinet - Quantity 59 o Chemical Fume Hoods - Quantity 9

4.0 Government Furnished

Filters, replacement, and repair parts for BSCs, HEPA filtered small animal isolators and fume hoods failing certification will be provided to the Contractor.

5.0 Deliverables / Schedule

Item No.

Deliverable / Item Title

Description Frequency Reference Delivery Format

Due By

1 On-site visits Certification, maintenance, and repairs for BSCs, isolators, and chemical fume hoods

Quarterly Section 3.1 and 3.13

On-site Due quarterly per the schedule in 3.13

2 Emergency Visits

Certification, maintenance, and repairs for BSCs, isolators, and chemical fume hoods

Maximum 10 on-site visits per year

Section 3.1 On-site Certifier must arrive on-site no later than 48 hours after notification

3 NSF

Accreditation Certificate

Provide one copy of the Certifier’s NSF Accreditation Certificate

All site visits Section 3.2 Email Upon arrival to site visits

4 Repair part numbers

Repair part numbers for BSCs, isolators, and fume hoods failing certification

All site visits Section 3.9 Email 10 business days following site visit

5 Certification Reports

Completed certifications reports

All site visits Section 3.11 Email 15 business days after certification completion

6.0 Travel

Travel is required quarterly and up to 10 times per year for emergency site-visit needs.

7.0 Contractor’s Key Personnel

Individual Certifiers must be accredited by the National Sanitation Foundation (NSF) on NSF/ANSI Standard 49 Class II (Laminar Flow) Biosafety Cabinetry for the certifier to calibrate and make repairs to the BSCs.

8.0 Security Requirements

The required Background Investigation is 5N, Moderate Risk Public Trust (Tier 2).

BI Information, Safety and Security Information The Homeland Security Presidential Directive-12 (HSPD-12), dated August 27, 2004, requires the development and agency implementation of a mandatory Government-wide standard for secure and reliable forms of identification for Federal employees and contractors, including contractor employees. As directed by HSPD-12, on February 25, 2005, the Department of Commerce issued FIPS PUB 201, which is a Federal standard for secure and reliable personal identity verification (PIV) for routine physical access to Federally controlled facilities or information systems. Office of Management and Budget (OMB) memorandum M-05-24 dated August 5, 2005, provides instructions for implementing HSPD-12 according to FIPS PUB 201, and M-08¬01, dated October 23, 2007, reminds all parties that a background investigation is required.

48 CFR 3052.204-71 requires each individual employed under a Federal contract shall be a citizen of the United States of America, or a non-U.S. citizen who has been lawfully admitted for permanent residence as evidence by a Permanent Resident Card (USCIS I-551).

Contractor’s shall identify in their quotes or proposals, the names and citizenship of all non-U.S. citizens proposed to work under the contract. Any additions of deletion of non-U.S. citizens after contract award shall also be reported to the CO or COTR.

All applicable contractor employees requiring routine physical access to Federally-controlled facilities and/or routine access to Federally-controlled information systems must go through the identity proofing and registration process, must have been successfully identity proofed, and have a successfully adjudicated National Agency Check with (Written) Inquiries (NACI) or Office of Personnel Management (OPM)/National Security (NS) community background investigation (BI) to serve on the contract. Contractor ID credentials will be issued after successful identity proofing of the contractor employee applicant and upon a successfully adjudicated NACI or OPM/NS BI. The contractor personnel will be required prior to starting work under this contract as well as maintaining it throughout the duration of the contract.

If an option year is exercised, the contractors must renew their credentials at the end of their period of performance. If no option year is exercised, the contractor must turn in their ID credential at the end of the performance period or when service on the contract ends.

The procedures to be followed by contractors and contractor employees are specified in DM 4620-002. The contractor must comply with the personal identity verification (PIV) policies and procedures established by the United States Department of Agriculture (USDA) Directives 4620-002 series which can be found at Common Identification Standard for U.S. Department of Agriculture | USDA

The contractor must appoint a representative to manage compliance with the PIV policies established by the USDA Directives 4620-002 and to maintain a list of employees eligible for a USDA LincPass required for performance of the work. Should the USDA Directives 4620-002 require the exclusion of a contractor's employee, the Contracting Officer will notify the contractor in writing.

The responsibility of maintaining a sufficient workforce remains with the contractor. Contractor employees may be barred by the Government from performance of work should they be found ineligible or to have lost eligibility for a USDA LincPass. Failure to maintain a sufficient workforce of employees eligible for a USDA LincPass may be grounds for termination of the contract.

All personnel must have a valid driver’s license or identification.

The contractor shall, through their own internal background investigation protocol and pre-employment investigation, ensure that each contractor employee submitted for a federal background investigation is reasonably expected to receive a favorable adjudication of their respective investigation.

The USDA will pay for the required federal background investigation. The government shall have and exercise full and complete control over granting, denying, withholding, or termination the background investigation clearance for employees.

The PIV Sponsor for this contract is a designated program point of contact, which in most cases is the COR, unless otherwise specified in this contract. The PIV Sponsor will be available to receive contractor identity information from (days and hours) to at (office address for registration). The Government will notify the contractor if there is a change in the PIV Sponsor, the office address, or the office hours for registration;

however, it is the contractor's responsibility to meet all aspects of the information contained in this contract on background investigations, safety and security information. The Contracting Officer (CO) will include the PIV Sponsor duties when issuing the designation memorandum to the COR (or other designated program/project manager).

Work under this contract may require that personnel have access to Privacy Information. Personnel shall adhere to the Privacy Act, Title 4 of the U.S. Code, Section 552a and applicable agency rules and regulations. Privacy of PIV information must be maintained in accordance with the Privacy Act of 1974.

The contractor must insert this clause in all subcontracts when the subcontractor is required to have routine unaccompanied physical access to a Federally controlled facility and/or routine unaccompanied access to a Federally controlled information system.

For additional information related to USDA implementation of HSPD-12, visit http://hspd12.usda.gov

Additional Requirements for Contractor Personnel The USDA personnel shall remain vigilant when openly communicating during meetings, being cautious not to discuss or share sensitive information and understand some topics aren’t suitable for contractor staff.

In all situations where contractor personnel status is not obvious, all contractor personnel are required to identify themselves to avoid creating an impression that such contractor personnel are Government officials. This can occur during meeting attendance, through written (letter or email) correspondence or verbal discussions (in person or telephonic), when making presentations, or in other situations where their contractor status is not obvious to third parties.

Contractor employee(s) must:

a. Not by word or deed give the impression or appearance of being a Government employee;

b. Wear appropriate badges visible above the waist that identify them as contractor employees when in

Government spaces, at a Government-sponsored event, or an event outside normal workspaces in support of the contract/order;

c. Clearly identify themselves as contractor employees in telephone conversations and in all formal and informal written and electronic correspondence. Identification must include the name of the company for whom they work;

d. Identify themselves by name, their company name, if they are a subcontractor the name of the prime contractor their company is supporting, as well as the Government office they are supporting when participating in meetings, conferences, and other interactions in which all parties are not in daily contact with the individual contractor employee; and

e. Be able to provide, when asked, the full number of the contract/order under which they are performing, and the name of the Contracting Officer’s Representative or the designated program point of contact.

2) If wearing a badge is a risk to safety and/or security, then an alternative means of identification may be utilized if endorsed by the Contracting Officer’s Representative or the designated program point of contact and approved by the Contracting Officer.

3) The Contracting Officer will make final determination of compliance with regulations regarding proper identification of contractor employees.

(4) If wearing a badge is a risk to safety and/or security, then an alternative means of identification may be utilized if endorsed by the Contracting Officer’s Representative or the designated program point of contact and approved by the Contracting Officer.

(5) The following disclaimer is recommended to be stated by the Contracting Officer, Contract Specialist, or COR at the beginning of a meeting that vendors attend: “Anything said during meetings, visits, or telephone calls must not be construed as a change to the contract. Nothing said or done in the meetings, visits, or telephone calls by any government attendee must be construed as a change to the contract. Only the Contracting Officer can make changes to the contract and the changes will be done in writing. Contractors are reminded to promptly notify the Contracting Officer of any conduct that may be regarded as a change to the contract in accordance with FAR 52.243-7, Notification of Changes.”

Removal from Contract Work The Contracting officer, the COR, designated program point of contact, or their designee will may require the Contractor to remove any employee(s) from the USDA facility or other real property should it be determined that the individual(s) is either unsuitable for security reasons or otherwise unfit to work at the USDA facility or property where work shall be performed under this contract. This shall include, but not be limited to, instances where an employee is determined, in the Government's sole discretion, to be incompetent, careless, insubordinate, unsuitable, or otherwise objectionable.

When the Government deems the employee’s continued employment to be contrary to the public interest, inconsistent with the best interests of security, or when the employee is identified as a potential threat to the health, safety, security, general well-being, or operational mission of the facility and its population.

The CO may also request the Contractor to immediately remove any employee from the work site if it is determined that individuals are being assigned to duty who have been disqualified for either suitability or security reasons or who are found to be unfit for performing duties during their tour of duty.

Contractor employees who are removed from Contract work shall be required to leave the work site immediately.

The Contractor shall comply with any removal request. For clarification, a determination to remove an employee will be made for, but is not limited to, incidents involving the most immediately identifiable types of misconduct or delinquency as set forth below:

a. Failure to receive a suitability determination, temporary clearance, or clearance from the Agency or OPM as applicable.

b. Violation of Federal, State, or Local law.

c. Violation of the Rules and Regulations Governing Public Buildings and Grounds, 41 CFR 101-

20.3. This includes the carrying or possession of explosives or items intended to be used to fabricate an explosive or incendiary device.

d. Neglect of duty, including sleeping while on duty, unreasonable delays, or failure to carry out assigned tasks, conducting personal affairs during official time or refusing to render assistance, or to cooperate in upholding the integrity of the security program at the work site.

e. Falsification or unlawful concealment, removal, mutilation, or destruction of any official documents or records, or concealment of material facts by willful omissions from official documents or records.

f. Disorderly conduct, use of abusive or offensive language, quarreling, intimidation by words or actions, fighting, or participation in disruptive activities that interfere with the normal efficient operations of the Government.

g. Theft, vandalism, immoral conduct, or any other criminal actions.

h. Selling, consuming, or being under the influence of intoxicants, drugs, or substances that produce similar effects while in or on federally controlled property.

i. Improper use of Government identification.

j. Unauthorized use of communication equipment on Government property.

k. Violation of security procedures or regulations.

l. Violation of Title 18,U.S.C.,Section 930, which prohibits the knowing possession or the causing to be present of firearms or other dangerous weapons in Federal facilities and Court facilities.

Either the COR, designated program point of contact, or their designee will make all determinations regarding the removal of any employee from the work site, except under certain conditions. When the COR, designated program point of contact, or their designee is not available, either during the day or after hours, or in situations where a delay would not be in the best interest of the Government or is identified as a potential threat to the health, safety, security, general well-being, or operational mission of the facility and its population, the COR, designated program point of contact, or their designee will have the authority to immediately remove the Contract employee from the work site.

Law enforcement officers of the Department of Homeland Security/Immigration and Customs Enforcement/Federal Protective Service (DHS/ICE/FPS) will have the authority to immediately remove any Contract employee from the work site who is found to be in violation of any of the items mentioned above and where a delay in removal would not be in the best interest of the Government or security or is identified as a potential threat to the health, safety, security, general well-being, or operational mission of the facility and its population. The COR, designated program point of contact, or their designee will be notified as soon after the incident as practical or at the beginning of the next business day if an action happened after hours. The COR, designated program point of contact, or their designee will make all official notifications to the Contractor. In the event of a dispute, COR, designated program point of contact, or their designee will make a final determination. Specific reasons for removal of an employee will be provided to the Contractor in writing by the COR, designated program point of contact, or their designee.

The Contractor is responsible for providing replacement employees in cases where Contract employees are removed from working at the work site or on the Contract.

The Contractor is responsible for ensuring the collection of badges and any government issued property from all contract employees and their subcontractors.

9.0 Data Rights

Any Confidential Business Information (CBI) data that would need to be sent for certification, repair, and maintenance purposes must be redacted as appropriate. The contractor does not have permission to share any data generated in the laboratory with outside vendors, firms, stakeholders, or personnel without specific approval from the COR.

10.0 Section 508 – Electronic and Information Technology Standards N/A

Attachment/Reference Documents NSF/ANSI Standard 49 (http://www.nsf.org) NSF/ANSI Standard 49 Class II (laminar flow) biosafety cabinetry applies only to Class II biological safety cabinets, as designed to minimize the hazards inherent in working with agents assigned to biosafety levels 1, 2, or 3. The standard defines the tests for which a cabinet must comply to become NSF Certified. The standard includes basic requirements for design, construction, and performance that are intended to provide personnel, product, and environmental protection, reliable operation, durability, cleanability, noise level and illumination control, vibration control, and electrical safety. In addition, the standard includes detailed test procedures and informational annexes, including recommendations for installation, field certification tests, and decontamination procedures.

NSF Certification Policies for Biosafety Cabinetry (http://www.nsf.org)