MRC Bridge_SOW_09.06.2024.pdf

Department of Health and Human Services

U.S. Food and Drug Administration

BRIDGE Statement of Work (SOW)

Muirkirk Road Complex (MRC)

Operational and Maintenance Support Services

September 6, 2024

A. BACKGROUND

1.0 MUIRKIRK ROAD COMPLEX FACILITIES

The U.S. Food and Drug Administration's (FDA) laboratory research and animal testing facilities located at 8301, 8401, and 8501 Muirkirk Road, Laurel, Maryland 20708 also referred to as Module I, Module II, and Beltsville Research Facility, respectively, is hereafter referred to as the FDA Muirkirk Road Complex (MRC). This complex consists of 195 acres of land.

FDA's Module I (Mod I) was built in 1984 and dedicated in August 1990, consists of 246,853 gross square feet. Mod I, houses research programs for the Center for Food Safety and Applied Nutrition (CFSAN), and Office of Regulatory Affairs (ORA). Research is designed to provide credible scientific information upon which informed decisions can be based. These facilities permit the Agency to improve its science base and prepare for the challenges of the 21st century. Animal studies are conducted according to contemporary scientific standards and in accordance with the Animal Welfare Act and the Guide for the Care and Use of Laboratory Animals, and with the flexibility to keep pace with technological developments. In particular, research is directed to assess significant health questions in areas that include pharmaceuticals, drug interaction, toxicology, and drug chemistry and food nutrition. The facility is accredited by the “American Association for the Accreditation of Laboratory Animal Care” (AAALAC).

Module II (Mod II) houses Center for Veterinary Medicine (CVM). The facility consists of 18 buildings totaling approximately 100,406 gross square feet and is designed with the most modern equipment available to facilitate the research mission. CVM is responsible for assuring the safety and efficiency of food, drugs, and food additives that will be given to animals. These include animals from which human foods are derived, as well as companion animals. This component of the regulatory testing group performs bioassays using animals. CVM is also presently AAALAC accredited.

Operational since 1964, the Beltsville Research Facility (BRF) is 35,061 gross square feet. The facility houses research programs for CVM. The facility includes the main research building renovated in 2014, a mechanical equipment building, a small block storage building, a maintenance building, three Hazmat containment units used for processing hazardous waste, one machine shop/fitness center building, and one steel storage building.

2.0 OBJECTIVE

The objective of this requirement is to provide 24-hour, 7 days a week operational and maintenance support services for all buildings and facilities under the U.S. Food and Drug Administration at the Muirkirk Road Complex (MRC).

3.0 SCOPE OF WORK

The Contractor shall provide a workforce of fully trained engineers, technicians, tradesmen, support personnel, and management staff to ensure round the clock satisfactory operational performance. All personnel must possess the proper security clearances and educational and technical qualifications to perform their assigned duties as outlined in Attachment 1 – MRC Labor Categories Duties and Qualifications. The Contractor, in a reasonable and timely manner, shall acquire, maintain, and/or accomplish all required training, certifications, licenses, equipment, supplies, and/or vehicles necessary to provide the full range of operational and maintenance services 24 hours a day, 7 days a week throughout the resultant contract’s period of performance.

The Contractor shall ensure all positions are fully covered at all times, thus the use of part-time Rovers and/or subcontractors maybe employed and utilized when addressing times of absence due to leave, extended vacations, weekend, and holidays.

4.0 GENERAL REQUIREMENTS

4.1 PERIOD OF PERFORMANCE

The period of performance (POP) for this bridge effort shall be from September 30, 2024 – September 29, 2025.

4.2 PLACE OF PERFORMANCE

Work is to be performed at the Food and Drug Administration’s laboratory research and animal testing facilities located at 8301, 8401, and 8501 Muirkirk Road, Laurel, Maryland 20708, referred to as Module I, Module II, and Beltsville Research Facility, respectively.

4. 3 HOURS OF OPERATIONS

The normal hours of Government operation will be 6:00 a.m. to 6:00 p.m. ET Monday through Friday. The Contractor shall maintain customer service hours throughout that period. All assigned key personnel are required to be on site during normal hours of Government operation.

Because of the nature of the facility and on-going research activities, preventative maintenance and other work performed by the Contractor, the Contractor shall be prepared to schedule work/repairs during and after normal duty and operating hours for specific, urgent, or emergent situations at no additional costs to the Government. All non-emergency repairs or preventive maintenance shall be coordinated with the Contracting Officer Representative (COR) 48-hours in advance, to be scheduled around research activities.

The Contractor is required to provide 24 hours a day, 7 days a week of servicing. Therefore, no overtime will be paid to the Contractor for normal facility maintenance and continuous utility operations that falls after normal Government business hours.

Federal Recognized Holidays: The Government adheres to the following holidays:

New Year’s Day Martin Luther King’s Birthday President’s Birthday Memorial Day Juneteenth Independence Day Labor Day Columbus Day Veterans’ Day Thanksgiving Day Christmas

However, the Contractor shall be required to provide the same service on national holidays that is provided during non-regular working hours. Any holiday that is declared under a Presidential Executive Order shall be treated the same as a recognized holiday.

The Contractor shall respond to emergency conditions and ensure the appropriate personnel provide continuous service to correct or otherwise stabilize emergency conditions in or around the MRC.

Maintenance personnel shall provide continuous service to correct emergency conditions that affect critical equipment and facilities or critical environmental conditions, as well as ensure the operation of animal care support equipment. Operations personnel shall be available to support continuous operation of utilities.

4.4 KEY PERSONNEL

The following labor categories are designated as Key Personnel: Project Manager, Assistant Project Manager, Chief Engineer, Office Administrator, High Voltage Electrician, and Building Automation System (BAS) Controls Technician.

Key Personnel shall be bona fide employees of the prime contractor or subcontractor of the prime contractor. Key Personnel are expected to serve for the duration of the contract for all contract periods, unless replacements with equal or better skills are nominated by the Contractor and accepted by the Contracting Officer (CO) in accordance with HHSAR 352.237-75 – Key Personnel.

All Key Personnel departures/replacement shall be submitted to the CO and COR at least thirty (30) calendar days prior to the effective date of change. Unless the change is due to an extreme situation such as termination of employment, serious illness, or death. Written acceptance or rejection notice will generally be provided within ten (10) business days. Key Personnel changes will be codified by modification.

All non-key replacements shall be submitted to the COR for review and concurrence at least fifteen (15) calendar days prior to the effective date of change.

After award, during contract administration, the Government requires the opportunity to review resumes and provide a determination of acceptability for all personnel (Key and Non-Key) prior to Contractor On- Boarding.

*Note: Key Personnel positions will not be shown in the contract as separate contract line item numbers.

All workforce positions, inclusive of key and non-key shall be included in the fixed unit price for support.

5.0 APPLICABLE TECHNICAL DOCUMENTS AND OPERATING CONSTRAINTS

The Contractor shall adhere and comply with the latest editions of the publications, documents, regulations, and rules as listed below. The Contractor shall be responsible for being cognizant and compliant with any changes, revisions or updates to these rules, procedures, and manuals, and ensuring that all Contractor personnel are trained on any changes, revisions, or updates. The Government will ensure access to all required Government forms and publications as required by the Contract and as needed by the Contractor, upon request.

Where a specific task or procedure is not defined in these publications, the Contractor shall contact the Government prior to performance of task. The Contractor shall provide and comply with its own copies of National and State codes, and trade association standards. The publications shall be kept on site and available for review.

FDA Staff Manual Guide 2610.7 (Requisitioning Articles or Services to Be Purchased).

FDA Staff Manual Guide 2620.2 (Accounting and Inventory Controls for Property Assigned to Custodial Areas).

21 CFR 58 (Good Laboratory Practice for Nonclinical Laboratory Studies) Department of Health and

Human Services/Food and Drug Administration.

29 CFR 1910.144 (Safety Color Code for Marking Physical Hazards).

29 CFR 1910, Subparts 0 (Machinery and Machine Guarding) and P (Hand Portable Powered Tools and Other Hand-Held Equipment).

29 CFR 1910.146 (Permit Required Confined Spaces, Confined Space Program Components.)

Resource Conservation and Recovery Act (EPA), applicable regulations in 40 CFR, Parts, 260-280.

21 CFR 2.31 Chapter 1, Subchapter A (Animal Welfare Act).

Guide For the Care and Use of Laboratory Animals - Institute for Laboratory Animal Resources, National Research Council, Revised 1996.

Applicable Federal, State and Local Codes.

National Fire Protection Association (NFPA) National Fire Codes.

Flat Glass Marketing Association (FGMA) Glazing Manual and Sealant System.

American Society of Mechanical Engineers (ASME) Boiler and Pressure Vessel Code.

National Plumbing and Washington Suburban Sanitary Commission (WSSC) Plumbing/Gasfitting code.

American Society for Heating, Refrigeration, and Air Conditioning Engineers (ASHRAE) Guide and

Data Books.

Sheet Metal and Air Conditioning National Association (SMACNA) Standard.

National Electrical Code

Clean Water Act (EPA) applicable regulations in 40 CFR, Parts 25, 104-117, 129, 131, 135-136.

Executive Orders regarding Energy Conservation Management and Environmental Management

GSA Public Buildings Maintenance Standards Guide, most current version.

Guide for the Care and Use of Agricultural Animals in Agriculture Research and Teaching, by the

Consortium for Developing a Guide for the Care and Use of Agricultural Animals in Agricultural Research and Teaching. 309 West Clark St., Champagn Ill.

Biosafety in Microbiological and Biomedical Laboratories, 5Th Edition or higher.

6.0 GOVERNMENT FURNISHED PROPERTY /EQUIPMENT/ FACILITIES /SERVICES

6.1 Government Furnished Property

The Government will provide, without charge, the delineated property, equipment, materials, property and/or services to successfully perform this SOW. The Government will provide the Contractor with space for storage of tools supplies; and regulated waste materials; office space; and Internet access. The space for these items is considered Government Furnished Property (GFP).

The Contractor is responsible for accountability and security of all Government owned property, equipment, and facilities furnished for Contractor use or otherwise entrusted to it; and for maintaining it in a clean, serviceable condition.

The Government will provide access to the buildings and grounds known as MRC.

FDA will provide Contractor’s key personnel with government furnished computers and an email outlook account. The Contractor designated point of contact shall receive access to FDA’s Archibus system for managing equipment preventative maintenance. Training of the Archibus system will be provided to the Contractor by FDA.

The Government will also provide keys, laptop, two-way radios, and ID badges to the Contractor. The Contractor shall be responsible for safeguarding and securing these items at all times.

The Government will furnish protective clothing to Contractor employees required for entry into restricted animal facility support areas. These items include cloth outer garments such as coveralls, lab coats or Tyvek suits, shoe covers, head covering, rubber gloves, and surgical type masks. Disposable type protective clothing shall be removed and disposed in the waste container as the Contractor exits from the animal facility support areas. Soiled cloth clothing shall be returned for laundering on site.

Compliance with the Occupational Safety and Health Act and other applicable laws and regulations for the protection of employees is exclusively the obligation of the Contractor. The Government will assume no liability or responsibility for the Contractor's compliance or noncompliance with such requirements. Prior to any modification of the facilities performed by the Contractor, the Contractor shall provide documentation describing in detail the modification requested. No alterations to the facilities shall be made without specific written permission from the CO. Repairs necessitated by Contractor misuse or negligence will be accomplished by the Contractor at its own expense. The determination for the alterations and costs associated will be decided with each request.

At the end of the contract, the Contractor shall return the facilities to the Government in the same condition as it was received, fair wear and tear and CO approved modifications may be expected.

The Contractor is not responsible for repairs necessitated by reason of negligence or misuse of equipment by Personnel other than Contractor Personnel, or by reason of any other cause beyond the control of the Contractor, except ordinary wear and tear. The Contractor shall notify the CO in writing of the existence or development of a defect that the Contractor considers it is not responsible for under the terms of the contract.

Example: Non- contract employee or person intentionally breaking glass panel.

6.2 Government Furnished Equipment

A representative listing of Government Equipment (Inventory) shall be provided at time of contract award.

The maintenance of this equipment is included within this SOW.

The Contractor shall ensure that all accountable property is controlled in accordance with the Federal Acquisition Regulations Subpart 45, SOW requirements, and the FDA Staff Manual Guide FDA 2620.2 (Accounting and Inventory Controls for Property Assigned to Custodial Areas) to be provided upon request.

The warranty provisions on all equipment, component parts, and accessories shall be safeguarded by the Contractor during the full duration of the warranty period, by complying with all manufacturers' requirements regarding maintenance services and intervals. The Contractor shall take full advantage of manufacturer warranty obligations.

Within 30 calendar days of the effective date of the contract, the Government in coordination with the Contractor’s representatives will conduct a joint inventory of all equipment and components at the Muirkirk Complex to validate condition, location, and exact quantities.

Due to renovations, upgrades and ongoing projects, there may be newer equipment that is not on the existing equipment list and older equipment that has been removed. Upon contract award, the Contractor shall be responsible to update and maintain the list as changes and updates occur. The Contractor and the COR shall walk the site and do an inventory of all equipment within 30-days of the start of each contract period. Any equipment found to not be on the master equipment list, shall be added. Refer to Attachment 2 – MRC Master Equipment Inventory List dated 08.21.2024

This will result in a master equipment and component listing and an equipment deficiency listing. Minor deficiencies easily corrected within the prescribed preventive maintenance labor allowance for each piece of equipment shall be accomplished as such and be excluded from the equipment deficiency listing. The equipment deficiency listing shall be submitted to the COR for review. The COR will prioritize repairs and decide which deficiencies are corrected first. The Government will pay the Contractor for labor and materials needed to correct said deficiencies and are considered additional services and are to be approved by the CO prior to incurring additional costs for such services. All applicable items found during the joint inventory reports that are not included in the resultant findings will be added by modification to this contract. Final versions of these listings shall be submitted to the COR within 30 calendar days from completion of the joint inventory. The Contractor shall be responsible for maintaining current versions of both listings and for stocking and replacement of all necessary spare parts.

All files, daily, weekly, and monthly logs, data sheets, records, manuals and worksheets, or any other technical material generated by the Contractor during this contract shall remain or becomes the property of the Government and shall be returned to the COR 10 calendar days prior to the expiration of the contract.

The Government will have the right to inspect or copy any files, daily, weekly, and monthly logs, records, reports, maps, worksheets, or any other technical material generated by the Contractor during this contract.

6.3 Government Furnished Facilities

The Government/COR shall designate space for use by the Contractor.

The Government will be responsible for the cost of all utilities such as electricity, natural gas, fuel oil, water, and sewage as necessary to ensure Contractor compliance with this SOW. In doing so, the Contractor shall be responsible for implementing a strong energy conservation program–keeping up with national initiatives.

The Government will provide telephone service needed for direct performance of the contract, including local service. Vehicles will not be provided. Use of facilities is restricted to that level which is specifically needed for contract performance areas. As such the BSL-3 laboratory and Vivarium areas may require Government escorts. Toilet areas for Contractor employees shall be available and may be used subject to the requirements of the contract. These accommodations shall be left in a clean and sanitary condition.

Restricted Use of Government Facilities and Property: The Contractor is advised that Government-owned facilities, property, equipment, materials, and/or utilities shall only be used in the performance of official duties as required by the contract. No Government owned facilities, property, equipment, material, and/or utilities may be used for private benefit at any time.

7.0 CONTRACTOR PROVIDED MATERIALS

The Contractor shall provide as necessary the materials and supplies required to maintain and perform the full and functional operations and repairs of the MRC. The Contractor shall provide all Contractor-specific administrative supplies required for the successful accomplishment of the requirements of this SOW.

a. Uniforms and Safety Gear: Street clothes shall not be worn by the Contractor’s personnel while performing work under this contract. The Contractor shall provide workers clothing, which shall carry a distinguishable Company emblem or patch. The Contractor shall provide its employees with safety glasses and other protective equipment required for the performance of the contract with the exception of what is provided by the Government for entrance into restricted areas. The Contractor shall notify the COR and the CO immediately if a uniform is lost, stolen, or misplaced.

b. Tools/instrumentations and devices: The Contractor shall provide hand tools, small power tools, and minor instrumentation (e.g., drills, grinders, voltmeters, electrical test equipment, sensors for calibrations, etc.) that is normally considered a “toolbox” item for the individual craftsmen. The Contractor shall be responsible for equipping the individual craftsmen to accomplish their normal duties.

c. Supplies/Materials: The Contractor shall provide all necessary supplies and materials for maintenance and repairs that fall within the repair definitions of this SOW. In addition, the Contractor is responsible to provide other expendable items for maintenance of the building including cleaners, air filters, grease, oil and other lubricants, refrigerants, belts, wiping rags, light bulbs, fluorescent tubes, lighting ballast, and hardware/nuts and bolts associated with the normal day-to-day operations and maintenance of the FDA building. The Contractor shall provide paint, caulking, and all associated materials and establish an inventory of materials used to accomplish routine work in order to accomplish most service calls and some repairs.

d. Contractor Threshold: The Contractor shall provide $5,000.00 for materials in the base contract period to pay for materials needed to accomplish Misc. Utility Work orders. This account shall be tracked by the Contractor and shall include details such as material cost, description, quantity, vendor, and each Misc. Utility work order for which the materials were purchased. The Contractor shall notify the CO and the COR in the event that 85% of the funds are exhausted. In such cases, the CO will decide whether or not a modification will be issued to add funding for the associated supplies and materials.

e. Vehicles: Company pickup truck and one golf cart.

8.0 WRITTEN PROCEDURES

The Contractor shall maintain quality control of operational support by preparation and adherence to written operating and maintenance procedures, i.e., facility operating plans, standard operating procedures. The procedures shall incorporate the requirements and recommendations of equipment manufacturers, industry standards, and commonly accepted principles of good management. At a minimum, the procedures shall include the following:

a) Contractor Staffing Plan, to include organization chart, job titles, position descriptions and responsibilities, procedures for filling unexpected absences of critical personnel or positions, hiring plan to fill personnel vacancies, and general management policies.

b) Work schedules for all personnel.

9.0 EXISTING DRAWINGS AND TECHNICAL DATA

Existing drawings and technical data are maintained by the Government and will be made available to the Contractor. Original copies of these drawings will not be removed from the premises, but copies can be made for Contractor use. At the conclusion of the contract period, drawings and technical data shall be provided to the COR.

Contractor shall provide drawings or detailed schematics to the Government when a change or new projects effect building or utility systems.

10.0 ENERGY CONSERVATION

The Contractor shall comply with energy and resource conservation practices and shall be responsible for conserving energy and utilities to the maximum extent possible. The Contractor shall be responsible to implement Agency initiatives and Executive Orders accordingly. A Utilities Conservation Supervisor shall be designated by the Contractor to ensure it remains aware of, and acts within the requirements of this SOW, to implement the newest utilities conservation initiatives. This may be a collateral duty. The Contractor shall review monthly utility readings and share findings with the COR to ensure the Utility Providers are billing accordingly. A written energy and water conservation report shall be submitted to the COR once every three months through the contract period. At a minimum, the report shall include recommendations on how to conserve energy and to improve the efficiency of building operations and show how optimum maintenance has conserved energy and natural resources. Included also shall be supporting documentation for consideration and possible implementation. Supporting documentation should include detailed life cycle cost analyses, payback timelines, etc. to allow the COR to make a sound judgment. The Contractor shall plan and develop energy conservation procedures when new technologies or Contractor awareness make such measures feasible and shall bring these to the attention of the Government. Contractor-generated energy conservation measures shall be approved by the Government COR and CO prior to implementation.

Water: Domestic hot water temperatures shall not exceed 120 degrees Fahrenheit at the point of use.

Contractor shall ensure that calibration is completed on all city water metering devices annually. All other hot water systems shall be operated at temperatures identified by the COR.

Electricity: Inside lights shall be turned off to the maximum extent possible and window lighting utilized.

During non-duty hours, interior and exterior lighting shall be eliminated except when it is essential for safety, research, and security purposes. All lights and equipment shall be turned off any time they are not needed.

Steam: Steam traps shall not be bypassed. Traps shall be maintained in accordance with the energy and water conservation plan to maintain operating order to prevent the bypass of live steam into the condensate system. The Contractor shall quarterly conduct a 3rd party steam trap survey which includes a sight, sound, and temperature assessment of all steam traps throughout the MRC to ensure proper functionality.

The Contractor shall implement a water management plan to conserve water and provide a leak detection program to identify underground leaks. The Contractor shall annually test the water mains for leaks and provide a written report to the Government.

11.0 SAFETY, HEALTH & ENVIRONMENTAL MANAGEMENT

11.1 General

The Contractor shall establish an accident prevention and safety program to provide safety, health protection, and personnel medical record maintenance as required by the Occupational Safety and Health Act (OSHA), as amended, and all Code of Federal Regulation segments implementing OSHA. The Safety, Health, and Environmental Plan(s) program shall be submitted to the CO and COR for approval 30 calendar days after contract is awarded.

The Contractor shall establish a confined space entry program in compliance with OSHA Standard 29 CFR 1910.146, Permit Required Confined Spaces, Confined Space Program Components, Categories of Confined Spaces, Atmospheric Hazards, Non-Atmospheric Hazards, Duties and Responsibilities of the Confined Space Entry Team, Confined Space Rescue and Confined Space Training Equipment Setup. The Confined Space Entry team shall include up to twelve (12) Contractor staff employees to include key personnel to cover a wide range of building trades, electrical, steam fittings, welding, HVACR, plumbing, and general building maintenance mechanics and any other trades needed that pertain to the work required in the confined space locations.

The Contractor shall provide a written Standard Operating Procedure (SOP) with the Confined Space Entry Program requirements. To include responsibility, specific responsibilities, Contractor Safety Manual, Contractor Operations and Multiple Trade Employees Identified, Definitions and Training Requirements to meet OSHA Standard 29 CFR 1910.146. The SOP shall be provided to the COR for approval 30 calendar days after contract is awarded.

The Contractor shall appoint a Safety Manager, which may be a collateral duty. The Contractor shall have a proactive environmental management program that not only ensures compliance with Federal, State, Local requirements, but also emphasizes conditions improvement of operation to reduce environmental impacts.

The Government reserves the right to conduct unannounced safety inspections at any time.

The Government reserves the right to investigate accidents involving Contractor personnel. The Contractor shall immediately report to the Government COR and CO any bodily injury or death of Contractor personnel while in the performance of official duties, damage to Government property, or loss of Government property caused by the Contractor, its agents, or employees.

The Contractor shall provide employees with protection against physical and health hazards by furnishing all industry standard protective equipment required for performance of this work statement (except that needed for entry into restricted areas as provided for in paragraph 3.1.13).

All personal protective equipment shall be equipment which has been approved by the appropriate organization such as the National Institute of Occupational Safety and Health (NIOSH), Mine Safety and Health Administration (MSHA), American National Standards Institute (ANSI), etc. Any conflicting instructions between these shall be brought to the COR for resolution.

The Contractor shall ensure that all signs, equipment, machinery, and hazards are marked or painted to identify the hazard. The colors and markings used shall conform to Occupational Safety and Health Administration (OSHA) regulations specified at 29 CFR 1910.144 (Safety Color Code for Marking Physical Hazards), and other State and local statutes as applicable.

The Contractor shall ensure that all operating equipment and tools have guards, which conform to the provisions of OSHA regulations, specified at 29 CFR 1910 Subparts OO and P.

All waste materials (defined in 40 CFR) being generated by the Contractor which could affect the environment shall be stored in designated waste areas and disposed of in accordance with Federal, State, Local regulations. The Contractor shall comply with all applicable Federal, State, Local regulations and with FDA specific waste management procedures.

All Contractor personnel that may be required to enter restricted areas shall be identified to the Government during the start-up period or upon employment, whichever is earlier. Contractor employees entering the restricted areas shall be required to comply with existing/applicable FDA standard operating procedures. Showering in and out of the barrier shall not normally be required. However, there may be instances where showering is required.

The Contractor shall maintain an accurate file of Safety Data Sheets (SDS) on site for all chemicals used to accomplish this SOW. Within 30 days of the execution of this contract, the Contractor shall establish an accurate file on-site of SDS of applicable materials in current use in the execution of this Statement of Work (SOW). Any changes to this file will be provided in writing to the COR immediately.

Contractor employees shall avoid blocking the hallways with carts, supplies, or equipment.

“Caution-wet-floor” signs are to be used as needed whenever a slippery floor condition is identified.

The Contractor shall comply with all MDE and EPA requirements that are necessary to the operation of the facility. These requirements change periodically requiring the Contractor to stay abreast of the requirements.

11.2 Fire & Safety

The Contractor shall include fire safety precautions and procedures in its safety and accident prevention plans called for in the various sections of this SOW. All fires shall be reported immediately by the most expeditious means.

The Contractor shall obtain a permit from the COR or designated alternate prior to any welding or burning.

The Contractor shall notify and coordinate with the COR 72 hours in advance of the proposed work and coordinate with a Government representative before any work is started and after completion of all work on a fire suppression system, fire hydrant, or water main; and shall obtain prior approval from the representative before turning off water which could affect the fire protection capabilities to any facility.

The Contractor shall participate in the Occupant Emergency Evacuation Plans and the Contingency/Emergency Plans established in each facility. The Government will make routine fire safety inspections, and the Contractor shall perform corrective actions on fire hazards noted by the Government.

11.3 Blood Borne Exposure

The Contractor shall develop and submit a written Exposure Control Plan to the COR 30-days from contract award date. The plan shall be designed to eliminate or minimize Contractor employee exposure to blood borne pathogens. The plan will be implemented after COR has reviewed the plan. FDA shall have access to the plan so FDA is aware of how the contractor will address safety and accident prevention throughout the life of the contract. The Contractor’s Exposure Control Plan shall meet the requirements of 29 CFR

1910.1030 and shall include at a minimum-:

a) Exposure Determination;

b) Methods of compliance to include universal precautions, work practice controls, personal protective equipment, and housekeeping;

c) Hepatitis B vaccination and post exposure evaluation and follow-up;

d) Communication of hazards to employees to include labels, signs, information, and training;

e) Record keeping;

f) Procedures for the evaluation of exposure incidents.

The Contractor shall report all incidents involving blood or other potential health risks immediately to the COR or designated representative.

Gloves and other appropriate proactive clothing shall be worn by Contractor employees whenever they anticipate touching blood, bodily fluids, and mucous membranes while executing their duties.

Hands shall be immediately washed after gloves are removed.

Clothing which becomes contaminated with blood or other bodily fluids during activities shall be removed immediately (or as soon as possible) and separated from other clothing until properly laundered.

Areas and equipment that becomes contaminated with blood or other bodily fluids should be cleaned immediately in accordance with industry standards.

Contractor employees shall report all injuries, no matter how minor, to the Contractor Project Manager.

Injuries resulting from equipment (i.e., chemical splashed in the eye, cuts from glass in the trash, etc.)

should also be reported to the COR. Contractor shall document all hazardous conditions identified on the site, including correction actions taken to eliminate or mitigate the condition. Each condition shall be reported in writing to the COR within 24 hours.

11.4 Inspections

Scheduled safety tests and Inspections shall be the responsibility of the Contractor to perform at no additional cost to the Government as follows:

Boiler plant safety devices, relief valves, safety valves, boiler safety devices and cut offs. To include MOD-1 Steam Boiler Plant, BRF Steam Boilers, MOD-2 Boiler Plant Outbuilding D-1, and MOD-2 Outbuilding F-1 Boilers - Annually, during the summer months.

Fire alarm system – Annually, at the beginning of the calendar year by a certified independent Contractor.

Fire Extinguisher inspection – Visual inspection monthly and annual maintenance reports as specified in 29 CFR, Part 1910.157I.

High voltage Switchgear and Transformers – As required in accordance with the National Electrical Testing Association by a company independent of the Contractor.

Safety showers – Activate monthly to flush line and verify proper operation.

Pressure Vessel Certification- As required by Federal, State, and local regulations. Performed by a company independent of the Contractor.

Load bank test of emergency generators – during base year to be performed by a company independent of the Contractor and to be conducted at the beginning of the calendar year.

Steam Traps- Quarterly the Contractor shall provide a 3rd party steam trap survey to include sight, sound, and temperature assessment to be conducted throughout the MRC on each steam trap in every building.

11.5 Training

The Contractor shall provide OSHA Hazard Communication training to ensure that all employees are informed of both the chemical hazards associated with the performance of the contract tasks and the appropriate protective measure before the task is initiated.

The Contractor shall provide the COR with annual reports of employee(s) training certifications.

The Government Safety Officer(s) will provide supplemental training to cover the above requirements of the OSHA Hazard Communication Training. In addition, the Government will provide training as appropriate for the biological hazards, radioactive materials, and other hazardous materials/hazardous waste, which Contractor personnel may encounter in the normal course of their assigned duties.

11.6 Government Notifications

The COR will be responsible to inform the Contractor of:

Any FDA chemical hazards which the Contractor’s personnel may encounter in the normal course of work on the premises.

Related precautionary measures to protect contract employees during normal conditions at the workplace and in foreseeable emergencies.

B. TASKS REQUIREMENTS

1.0 SPECIFIC REQUIREMENTS

The Contractor shall maintain a single point of contact continuously during normal working hours on-site at the facility for reception of all work requests and orders. A Contractor representative shall reside in the Project Manager’s Office during normal hours to receive, process and otherwise manage all incoming work requests to include ones received from the FDA’s ERIC Call Center.

The Contractor shall review each work request for completeness, understanding, and clarity. The Contractor shall analyze each work request thoroughly, breaking all tasks down to the simplest elements possible.

Service calls shall be placed directly to the Contractor via telephone or e-mail by the COR or a Government Center Managers. Miscellaneous Utility Work orders will be issued to the Contractor by the COR or designated Government Representative.

2.0 EQUIPMENT PREVENTIVE MAINTENANCE PROGRAM

Preventive Maintenance (PM) is an essential aspect of this SOW. The Contractor is required to develop and implement PM plans in accordance with the GSA Public Buildings Maintenance Standards Guide, most current version and Time Standards generated by the FDA automated Facility Management System, Archibus, which the Contractor will obtain access once cleared for Government IT use. The Government may, at its discretion, grant an interim approval of PM plans prior to approval of the finalized plans. FDA will coordinate with Archibus system administrator to provide access and training to the system. Four (4) key personnel will be provided a Government Furnished Laptop as (GFP) they will access with the GFP Laptop and have an outlook account set-up.

PM plans for all items contained on the Equipment List, shall be based on the requirements set forth in this SOW, manufacturer’s recommendations, and applicable codes–whichever is most stringent. For specialized equipment where GSA PM guides do not exist, the Contractor is required to assist with the development of maintenance guidelines utilizing the manufacturer’s guidance for approval by the COR.

The guidelines shall be submitted as part of the PM plan and include a listing of items and components to be maintained, inspection and maintenance techniques, personnel schedules for performance; PM inspections, services, and frequencies, and recording methodology.

A Preventative Maintenance schedule shall be provided by the Contractor and subject to Government’s approval. The first schedule shall be submitted to the COR for approval as part of the Preventative Maintenance Plan no less than 90 days after contract award, and annual schedules shall be prepared thereafter. For equipment in which scheduled maintenance is to be performed less frequently than annually (e.g., every 3 years, every 5 years, etc.,), the maintenance shall be proportionally scheduled for completion during the first nine (9) months of the appropriate contract period, taking into consideration the existing PM cycle.

The Contractor shall manage maintenance records at all times in order to establish maintenance and repair history on each piece of equipment. It shall reflect all maintenance performed including scheduled and accomplished dates, labor hours, servicing technician(s) name, materials expenses, and other valuable information needed to establish a comprehensive predictive maintenance program. Copies shall be maintained throughout the life of the contract and shall be provided to the Government as requested by the COR.

The Equipment Preventative Maintenance Program shall be executed within 30 days after joint inventory has been completed. Records for all equipment and systems shall be maintained accurately and up to date at all times. The Contractor shall update its PM program as necessary to reflect any changes in equipment inventory (e.g., additions or deletions), with such updates being subject to Government approval.

Proposed revisions shall be provided to the Government for approval in writing within 15 calendar days after their need is identified.

The Contractor shall ensure all equipment is maintained in a safe operating condition and in fire safe condition at all times according to applicable OSHA standards.

3.0 FACILITY OPERATING PLANS

Facility operating plans are also required in various sections of this SOW to identify all requirements for safe, efficient operation of the utility systems and services provided by the Contractor. Operating plans shall be submitted as part of the work management plan, refer to Section C for more details.

Operating plans shall be prepared by the Contractor and in accordance with the following order of precedence:

A. Manufacturers’ recommendations and standards, B. Federal, State and Local codes, C. Procedures outlined herein, D. The Latest Industry standards.

Unless otherwise specified herein, operating plans shall include, but are not limited to complete description of operating procedures; personnel organization and schedules; reporting methodology; operational testing, measuring, recording, and reporting of operating data, to include operations logs; operator inspections and services and their frequencies, and identification and reaction to operational emergencies. Logs, records, inspection services and other documentation maintained by the Contractor shall be available for Government review. Proposed revisions shall be provided to the Government for approval within 15 calendar days after their need is identified.

4.0 BUILDINGS AND STRUCTURES PREVENTIVE MAINTENANCE

The Contractor shall develop and submit to the Government, a Buildings and Structures Preventive Maintenance (PM) Plan for all systems. This is to be submitted for approval no later than 30 calendar days after contract award and annually thereafter. In addition to the requirements for PM, the plan shall include:

• Procedures to maintain the MRC to meet animal care and use guidelines and good laboratory practices.

• Contractor’s maintenance of perimeter fencing gates, actuators, and associated hardware to keep the property secure. The Government will maintain pasture fences.

The Contractor shall perform semiannual inspection of all roofing and perform any repairs. The specific roof leaks that occur during the year shall be patched as they occur for the protection of the facility. All roof repairs shall be documented and tracked throughout the life of the contract. Semiannual inspections should be documented within annual report identifying any findings and conditions observed and provide to the Government. Leaks that adversely affect the building integrity shall be patched on an emergency basis. Any repair work shall be accomplished in accordance with the applicable roof warranty.

Because of the nature of the facility and on-going research activities, preventive maintenance and other work performed by the Contractor, the Contractor shall be ready to schedule after normal duty hours and the operating hours. The Contractor is required to provide 24 hours a day, 7 days a week of servicing. Therefore, no overtime will be paid to the Contractor for normal facility maintenance and continuous utility operations that falls after normal Government business hours.

5.0 MAINTENANCE, ALTERATIONS, AND REPAIR (MAR) OF BUILDINGS AND

STRUCTURES

The Contractor shall perform all preventive and remedial maintenance, and operation of the buildings, its equipment, and structures to assure that the facility remains capable of carrying out the assigned mission of the offices/labs assigned to the facility. The maintenance, alteration, and repair (MAR) of the facility shall include but is not limited to all structural features such as foundations, walls, doors, windows, roofing, stairs, fixtures, hardware, exterior and interior painting and glazing, interior piping and plumbing, interior and exterior electric, heating ventilation air conditioning and refrigeration systems (HVACR), fire protection and alarm systems, and elevators. The Contractor shall move and subsequently return all furniture, furnishings, and equipment necessary to accomplish MAR activities. The Contractor shall respond immediately to emergency conditions.

Asbestos-containing materials (e.g., pipe materials are present at Beltsville Research Facility (BRF) in the crawl space within the utility chase located under the loading dock (abandon in place) and underground old abandon heating distribution system that has been abandon and the current sanitary sewer line leaving BRF these systems contain asbestos materials. The Contractor shall immediately notify the COR whenever a friable suspect material is discovered. The COR and CO may require the Contractor to perform asbestos abatement through a work order.

Workmanship: The Contractor shall protect all adjacent surfaces and the building contents during MAR activities. Work areas left unfinished overnight or on non-workdays, or unattended shall be temporarily closed to the extent necessary to protect personnel from possible safety hazards and to protect the facility from weather damage. Work shall be warranted against defects in workmanship.

Cleaning: The Contractor shall be responsible for cleaning all areas immediately after the work has been performed. Cleaning shall include, but not be limited to broom cleaning, removal of all smudges, grease, stains, dirt, paint drips, and refuse resulting from the Contractor’s work. Carpet which is soiled shall be cleaned or replaced as necessary by the Contractor.

Coordination: The COR shall be responsible for all necessary coordination with building occupants. The Contractor shall identify the need for and obtain all necessary permits and licenses for alterations.

6.0 REMEDIAL MAINTENANCE AND ALTERATION

The Contractor shall process requests for remedial maintenance and alterations through FDA ERIC and FDA Archibus systems, as well as COR directives.

Alterations to the Contractor-occupied facilities for contractor benefit shall be processed through its work management system and receive prior approval from the COR and the CO. The Government is not required to pay for such alterations.

6.1 SPECIFIC TASKS AND STANDARDS

Architectural: The Contractor shall be responsible for all architectural elements of the building which include, but are not limited to floors, walls, ceilings, and roof construction, building finishes, door hardware, foundations, water proofing seals, and flashing. Interior and exterior finishes, trim, and I shall be maintained to match existing materials. Responsibilities shall include, but are not limited to the following:

Exterior Walls: The Contractor shall restore any damaged or deteriorated wall areas to a serviceable, watertight, and weather tight condition. This includes but is not limited to replacing damaged masonry units, tuck pointing loose or eroded mortar joints, sealing penetrations in wall openings, replacing damaged or deteriorated siding and exterior trim, and replacing miscellaneous hardware items.

Masonry Units: All damaged masonry units (e.g., brick or block) shall be replaced with a unit of the same size, color, texture, and quality. Re-pointed joints shall match undamaged joints. Hairline cracks, which develop on interior block wall surfaces or at joints, shall be sealed with sealant caulking product or an equivalent product approved by the COR. Repaired interior block surfaces or cracks shall be painted to match the existing surface color and performance characteristics. Other masonry tasks shall include but are not limited to laying of brick, terra-cotta tile and blocks, cement, and cinder and concrete blocks; tearing out of old masonry brick work and masonry walls; pointing up of old mortar and general repairs to bricks; repair and maintenance of masonry structures such as small buildings, chimneys, roofing, stone, foundations, sidewalks, ramps, stairways, steps, and walls. The stone patio area shall be maintained, leveled as needed.

Sand is to be used as joint filler as needed.

Joints: Joints between window or doorframes and the exterior wall shall be sealed with a compound that is flexible and water resistant. All sealants and procedures shall be approved by the COR and shall comply with manufacturer’s recommendations and current industry standards.

Wood Trim: The Contractor shall repair or replace wood trim. Surfaces to receive trim shall be thoroughly cleaned of sealant and paint buildup prior to installation of trim. Damaged or deteriorated insulation board or underpayment shall be treated for termites, if there is evidence of termite activity, prior to trim replacement.

Termite damage shall be reported to the COR; treatment for termites will be provided by the Government.

Roofing and Accessories: The Contractor shall repair roofing deficiencies as required by inspection or emergencies to repair leaks. The Contractor shall protect critical equipment affected by the leaks. Any damaged decking shall be replaced before roofing and ballast is installed. Membrane and ballast roofing, flat or gradient, shall be repaired or replaced to conform in type and kind of materials with existing structure and shall be repaired in accordance with manufacturers’ instructions.

Roof…