Perfromance Work Statement.docx

Updated February 2024

CERTIFICATION & DECONTAMINATION OF BIOLOGICAL SAFETY CABINETS

Performance Work Statement

A.1 SCOPE OF CONTRACT

The Contractor shall provide all services including all labor, equipment, parts, materials, supplies, supervision, tools, equipment, transportation, and insurance necessary in order to perform all elements of the work identified in the Performance Work Statement and Attachments for Certification, Decontamination, Maintenance of Laboratory Primary Barrier Equipment, Animal Isolators, Quarantine and Containment Facilities in-situ HEPA Filters, Disassembly, and Reassembly. Units being decontaminated are not specific to the inventory list. Any unit can be decontaminated. All work shall be delivered Freight on Board (FOB) Destination, within the consignee premises located in Beltsville, MD and Washington, DC.

A.2 SCHEDULE OF ITEMS

The Contractor agrees to perform all required work as described in the below referenced items and contract specifications.

A.3 DESCRIPTION

Barrier Maintenance and Decontamination Services.

A.4 PERFORMANCE PERIOD

Base Year: 12 months Option Year One: 12 months Option Year Two: 12 months Option Year Three: 12 months Option Year Four: 12 months

OBJECTIVES:

For the certification and maintenance of laboratory primary barrier equipment, animal isolators, and quarantine or containment facilities in-situ HEPA filters, as well as disassembly/reassembly of primary barrier equipment.

TABLE OF CONTENTS

6.1 Maintenance and Repair

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2.

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5.

6.

7.

7.1 Personnel Qualifications

8.1 Supervision, Safety and Contract Work

1.1 BACKGROUND

The Beltsville Location comprises of three Centers: 1) Beltsville Agricultural Research Center (BARC), 2) Beltsville Human Nutrition Research Center (BHNRC), and 3) the U.S. National Arboretum (USNA). The Beltsville Location is part of the Agricultural Research Service (ARS), in the U.S. Department of Agriculture (USDA). It is situated about 15 miles northeast of Washington, D.C., 10300 Baltimore Avenue (U.S. Route 1), Beltsville, Maryland. It covers more than 6,000 acres and supports approximately 1,000 employees. The Beltsville Location is a complex and extensive facility established to perform a myriad of agricultural research activities. Included in this facility are research laboratories, industrial shops, animal holding facilities, and administrative offices. These activities are located at the Beltsville Agricultural Research Center (BARC), the Beltsville Human and Nutrition Research Center (BHNRC), and the U.S. National Arboretum (USNA) in Beltsville, Maryland. Attachment 1 provides specific information for each biosafety cabinet, clean bench and animal care module including type, model, and location of each piece of equipment. Attachment 2 provides the List of Buildings and Schedule of Service. The Beltsville Location Safety and Occupational Health Unit (SOHU) is responsible for conducting a comprehensive intramural safety program to create and maintain a safe and healthful environment for the Beltsville Location employees, visitors, and contractors.

2.1 SCOPE OF WORK

This requirement is to perform annual certification testing of primary barrier equipment listed on Attachment 1 and to perform up to twenty-five (25) decontamination services. Unscheduled maintenance and repairs require approval from the Contracting Officer’s Representative (COR) or Contracting Officer (CO) prior to commencing work. The Contractor shall furnish labor, supplies, materials, calibration equipment, vehicles, and qualified personnel with appropriate certifications necessary to perform the work specified in the contract. The twenty-five decontamination services are to be applied to equipment scheduled for surplus or to be transferred to another laboratory and the service must be approved by the COR before proceeding. The contractor shall immediately, but no later than 24 business hours after discovery, notify the COR in writing of the existence of the development of any defects in, or repairs required, to the scheduled equipment which the Contractor considers he/she is not responsible for under the terms of the contract. The Contractor shall provide a quote of the existence of repairs and services required to the scheduled equipment as soon as the Contractor is able to the COR. Types of equipment and items will include but not limited to the type of or biohazard levels listed below:

Class I Biological Safety Cabinets (BSCs) Class II Type A1 BSCs Class II Type A2 BSCs Class II Type B1 BSCs Class II Type B2 BSCs Clean benches/Laminar Flow Hoods Animal isolators and dump stations (HEPA-filtered) PCR Enclosures Insect Quarantine Facility

2.2 Certification of primary barrier equipment shall be in accordance with the specifications contained in the owner’s manual and this Performance Work Statement (PWS); if there is a conflict, the owner’s manual shall prevail. The Contractor shall perform the required service and repairs within the building where the equipment is located.

2.3 The contractor shall immediately, but no later than 24 business hours after discovery, notify the COR in writing of the existence of the development of any defects in, or repairs required to the scheduled equipment that the Contractor considers they are not responsible for under the terms of the contract. The Contractor shall furnish the COR with a written estimate of the cost to make the necessary repairs.

2.4 Decontamination of primary barrier equipment shall be in accordance with the specifications of this Performance Work Statement (PWS); if there is a conflict, the owner’s manual shall prevail. The Contractor shall perform the decontamination service within the building where the equipment is located. The twenty-five (25) decontamination services included as part of this contract must be used for primary barrier equipment that are scheduled for surplus or transfer to another laboratory, and the Contractor must request approval from the COR before proceeding. The units are not only specific to any of the barrier equipment identified in the inventory provided; the barrier equipment can be any barrier equipment that is identified by the COR whether on the inventory list or not.

2.5 Services required by this contract shall be performed at the following facilities: Beltsville Agricultural Research Center (BARC) 10300 Baltimore Avenue, Beltsville, MD 20705

Beltsville Human Nutrition Research Center (BHNRC) 10300 Baltimore Avenue, Beltsville, MD 20705

United States National Arboretum (USNA) (MD Location) 10300 Baltimore Avenue, Beltsville, MD 20705

United States National Arboretum (USNA) (DC Location) 3501 New York Avenue, NE Washington, DC 20002

2.6 The contract is for a Base – 12-month contract with the four (4) one-year options, total Not to Exceed (NTE) five (5) years.

3.1 HOURS OF SERVICES

3.1.1 All work shall be performed during normal working hours, 7:30 a.m. to 4:30 p.m., Monday through Friday, excluding Federal holidays except where noted in the PWS. Any services performed outside of these hours will be coordinated with the Contracting Officer’s Representative (COR) or Contracting Officer (CO).

3.1.2 Inclement Weather, Holiday’s, and Facility Closures: When Government employees because of inclement weather, potentially hazardous conditions, or any other exceptional circumstances are released from work, the Contractor should coordinate with the COR as soon as possible for direction. The Contractor will not be required to perform certifications or maintenance that day and will coordinate with the COR and CO for guidance. If a closure happens during the normal duty day, the Contractor will coordinate with the COR to determine when the Contractor can depart since current working conditions may not allow the Contractor to stop in the middle of a certification or until the equipment is properly secured from creating a hazard.

3.1.2 After-hours service may be required. The Contractor must coordinate with the COR prior to performing any after-hours services. The COR or the CO will have final approval over allowing work to be completed after 4:30pm local time. A government employee must be on site and available during any overtime requests.

3.1.3 If the COR requests after hour services to complete a project or to not inhibit the scientist experiments, the Contractor must agree prior to commencing after hours work.

3.1.4 The Contractor shall be flexible enough while on-site performing scheduled certifications, decontaminations, and repairs, so as not to disrupt any experiments without first obtaining permission from the equipment user or owner.

3.1.5 The following are Federal holidays to be observed by the Contractor:

Juneteenth National Independence Day Independence Day

4.1 EQUIPMENT CERTIFICATION AND DECONTAMINATION SCHEDULE

4.1.1 The COR will provide an annual maintenance schedule to the Contractor that will provide for annual maintenance and certification of all equipment. The schedule is based on the equipment list (Attachment 2) provided by the COR with current certification dates. The COR shall submit a monthly equipment certification schedule by the 25th of each month for the following month to be completed by the Contractor.

4.1.2 The Contractor will be notified by the COR in case of needed certification due to unscheduled maintenance/repairs, installation, or relocation of new equipment.

4.1.3 The Contractor shall inform the COR of any equipment that has not been inventoried or its location has changed (e.g., new equipment, equipment relocated, etc.). If the equipment location is incorrect on the spreadsheet either party shall notify the other to have the equipment database updated. Upon completion of service, the Contractor shall update the equipment database with the proper information and provide that to the COR. The Contractor may use their customer management tracking system as a database.

4.1.4 The priority given to unscheduled service, such as decontamination services or service call requests will be determined by the order in which they are requested. Deviation from this order or priority given to new work can be determined only by the COR.

5.1 SERVICING EQUIPMENT AND SYSTEMS

The main purpose of this contract is to eliminate unscheduled shutdowns and contribute significantly to the continuous operating economy and integrity of the system. All work is to be in compliance with NSF/ANSI 49.

5.1.1 Certification of Biological Safety Cabinets

5.1.1.1 Biosafety cabinet owners or users rely on field certification to confirm that a cabinet meets all the design criteria contained in the National Sanitation Foundation (NSF) International Standard/American National Standard 49 – current edition Class II (laminar flow) Biosafety Cabinetry Standard and all the operating criteria for all Class II Type A1, A2, B1 and B2 biological safety cabinets.

5.1.2 Certification of all Laminar Flow Clean Benches and all Types of HEPA- filtered Animal Care Modules.

5.1.3 Certification of in-situ HEPA Filters in air handling units in Containment Facilities (e.g., Insect Quarantine Facility).

5.1.4 Decontamination Services

5.1.4.1 Microbiological decontamination of barrier equipment prior to repairing or replacing components located in contaminated plenums in accordance with, but not limited to, standards and codes referenced within the PWS. Decontamination may be accomplished with an appropriate surface disinfectant and/or by use of formaldehyde gas or hydrogen peroxide vapor as indicated for BSCs.

5.1.4.2 Decontamination of equipment, systems, tissue culture rooms, and laboratories or other large spaces as required by special program circumstances. These services will be performed at the specific request of the COR.

5.1.4.3 The Contractor, upon completion of the decontamination of equipment, shall affix in plain sight a tag or other signage certifying that the equipment is decontaminated. Information shall include Contractor’s company name, date of decontamination, process used, and technician’s identification. In addition, the Contractor will provide a certificate of decontamination to the COR that includes the information of unit, date of decontamination, and signature of certified individual that performed the decontamination.

5.1.4.4 If the HEPA filter(s) must be removed from the equipment, the Contractor shall properly baggage them for disposal and place them at the COR designated area.

5.1.5 MONTHLY REPORTS

5.1.5.1 The Contractor will provide a Service Report to the COR for all equipment serviced by the 5th day of the month for work completed in the previous month (i.e., 1- 31 January report is due on 5 February) or upon request. The Service Reports at a minimum will contain the following information, as applicable:

Certification and decontamination of biological safety cabinets Leak tests of filters and cabinets Velocity profile and exhaust measurements Ultraviolet light intensity measurements Pressure leak test(s) Leveling of cabinet(s) Ground fault interrupter test(s) Ground continuity test(s) Noise level test(s) Lighting intensity test(s) Vibration tests (when performed at request of COR) Details of Laskin nozzle Personnel protection test Resistance to distortion and tipping Calculated inflow velocity for Class II Type A1, A2, B1 and B2 Supply air volume Beltsville Location inventory number, building and room number, equipment ID, manufacturer and model number, manufacturer serial number, class/type, and prior certification date, as applicable Record of all repair work and parts replacement accomplished including labor hours and part(s) costs Service summary

5.1.5.2 Upon completion the Contractor will provide a Field Certification report that will include all certification data for each piece of equipment that was certified that month or upon request. The report will contain at a minimum the building number, room number, model, serial number, type of equipment, last test date, next certification date and comments.

5.1.5.3 The Contractor should keep this data electronically and be able to provide updates to the COR on the database as needed.

5.1.5.4 The Contractor will complete all assigned equipment certifications within the month assigned. If the Contractor is unable to do so, the Contractor will submit in writing to the COR as to why the equipment was not certified during that month.

6.1 MAINTENANCE AND REPAIR

6.1.1 Provide maintenance and repair of all the Beltsville Location’s Class I and Class II Types A1, A2, B1 and B2 biological safety cabinets: horizontal and vertical laminar flow clean benches, and all types of HEPA-filtered animal care modules.

6.1.2 The Contractor is responsible for all annual routine maintenance per the owner’s manual equipment. Repairs or worn parts replacement request will need an estimate provided to the COR and CO for approval prior to commencement of the work. Refer to paragraph 6.1.3 for providing estimates.

6.1.3 The Contractor shall provide a breakdown of all repairs (parts and labor) to the COR and CO for approval prior to commencing equipment repairs. Any repairs done without COR or CO approval may result in the Contractor not being paid for those repairs.

6.1.4 Unscheduled services

6.1.4.1 Due to the nature of the equipment, any service required other than the annual certification is considered an unscheduled service. Requests for unscheduled service, which may include field testing at the time of new equipment being installed, decontamination, relocation of equipment, repairs, and filter changes, will be requested from the Contractor by the COR. The Contractor will respond to these requests for unscheduled service within two (2) working days after receipt of the request.

6.1.4.2 The Contractor may be asked to provide unscheduled service after non-working hours or on weekends. Such requests will be made only in extreme cases or when the area involved needs to be unoccupied. All preparation will be coordinated between the COR and the Contractor.

6.1.3 Disassembly and re-assembly of equipment

6.1.3.1 During certain circumstances, such as equipment relocation, it may be required for the equipment to be partially disassembled. The Contractor may be asked to disassemble and re-assemble biological safety cabinets, or other primary barrier equipment.

7.1 PERSONNEL QUALIFICATIONS

7.1.1 The Contractor must provide service personnel who have the following certifications:

7.1.1.1 National Sanitation Foundation (NSF) and American National Standards Institute (ANSI) 49 (NSF/ANSI 49) Accredited Biological Safety Cabinet Field Certifier(s), or extensive training and experience in performing certifications, maintenance, and repairs which meet NSF/ANSI 49 criteria in how they test the cabinets. In addition, the reports will be supervised by an NSF/ANSI 49 certified Contractor who will review their report and be available via phone for questions and trouble shooting.

7.1.1.2 The Contractor will provide proof of certification, training, and experience for each employee.

7.1.1.3 Prior to commencement of work on this contract, the Contractor will verify that the standards utilized for certification will be within the due dates of calibration.

7.1.2 Personnel are required to read and communicate in English. Personnel shall comply with all ARS, BARC, BHNRC, and USNA requirements, facility’s traffic, safety rules, security regulations, and any other instructions pertaining to the conduct of personnel while on Government property. The Contractor shall place its employees on notice that infraction of any rules, regulations or prohibitions may be grounds for removal from Government property. See USDA REE Policy and Procedure (P&P’s and Manuals) under website: http://www.ars.usda.gov and https://www.afm.ars.usda.gov/ppweb/pps- and-manuals/.

8.1 SUPERVISION, SAFETY AND CONTRACT WORK

8.1.1 The Contractor shall ensure that work required under this contract is monitored by providing and appointing supervision (Supervisor and/or Alternate) that will be on site or readily available, via telephone call or email, during the performance of this contract. The Contractor Supervisor will review and sign off the documentation and submit responses to the COR.

8.1.2 The Contractor shall register all employees servicing primary barrier equipment in the Beltsville Location with the COR upon commencement of the contract. When new personnel are hired, they also shall register before starting work. The Government shall provide all new employees with Identification Badges (ID) and Proximity Cards (as needed). The Contractor shall immediately report to the COR, in writing, any termination of Contractor personnel.

8.1.3 The Contractor shall report all damage to Government property, personal injuries, and/or hazardous conditions to the COR as soon as possible but, no later than the start of the next working day, after such occurrence.

8.1.4 The Contractor shall observe the necessary safety precautions throughout the performance of this contract. At a minimum, the Contractor will provide their personnel with clean outer garments such as laboratory coats or designated clothing to be worn while performing duties. Additional personal protective equipment required for the safe performance of work shall be determined and provided by the Contractor as needed.

8.1.5 The Contractor will observe and comply with the appropriate laboratory safety practices described in the following documents.

8.1.5.1 Biosafety in Microbiological and Biomedical Laboratories, CDC/NIH, latest edition.

8.1.5.2 Occupational Safety and Health Standards for General industry (29 CFR 1910).

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