Attachment 5 TO 1 Statement of Work 07102024 REVISED VS1.pdf

75F40124R00001 Task Order One (1), Attachment 5 Irvine Operations & Maintenance, Landscape, Pest Control, Waste Management, and Janitorial

PART A – STATEMENT OF WORK

A.1 BRIEF DESCRIPTION OF SERVICE AND SUPPLIES

The Food and Drug Administration's (FDA) requires a Contractor that can provide Operation and Maintenance Services, Janitorial Services, Landscaping Services, Waste Management Services, and Pest Control Services for the Los Angeles District Office (LOSDO) and Pacific Southwest Food and Feed Laboratory (PFFL) the Pacific Southwest Medical Products Laboratory (PMML). The FDA facility is located at 19701 Fairchild Road, Irvine, California 92612 referred to as Irvine.

A.3 FUNDING

Funds for the services provided shall be obligated on this task order.

A.4 OBJECTIVE

The first objective is for a providing severable services that covers the Food and Drug Administration's (FDA) Los Angeles District Office (LOSDO) and Pacific Southwest Food and Feed Laboratory (PFFL) the Pacific Southwest Medical Products Laboratory (PMML) located at 19701 Fairchild Road, Irvine, California (Irvine) for Operations and Maintenance (O&M) services, janitorial, landscaping, pest control, and waste management.

Second objective is to provide services stated herein with the utmost reliability to minimize any negative impacts on critical building systems which could adversely affect the HHS/FDA/Irvine mission.

A.5 INSPECTION AND ACCEPTANCE

Pursuant to the appropriate inspection clause, final inspection and acceptance of all items called for by this contract shall be made by the FDA Contracting Officer at:

Acceptance will be based on performance evaluation criteria defined.

A.6 TASK ORDER ONE, SUMMARY SCHEDULE, QUANTITIES

See attachment 8 Pricing Table

PART B. Contract Terms and Conditions—Commercial Items

B.1 FAR Clauses

FAR 52.252-2 Clauses Incorporated by Reference. (Feb 1998)

This task order incorporates one or more clauses by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make the full text available. Also, the full text of a clause may be accessed electronically at this/these address(es): www.acquisition.gov.

PART C CLAUSES

C.1 Federal Acquisition Regulation (FAR) Clauses and HHSAR Clauses by Full Text

C.1.1 HHSAR Clauses by Full Text

C.1.1.1 HHSAR 352.232-71 – Electronic Submission of Payment Requests

a. Definitions. As used in this clause-

Payment request means a bill, voucher, invoice, or request for contract financing payment with associated supporting documentation. The payment request must comply with the requirements identified in FAR 32.905(b), "Content of Invoices" and the applicable Payment clause included in this contract.

b. Except as provided in paragraph (c) of this clause, the Contractor shall submit payment requests electronically using the Department of Treasury Invoice Processing Platform (IPP) or successor system. Information regarding IPP, including IPP Customer Support contact information, is available at www.ipp.gov or any successor site.

c. The Contractor may submit payment requests using other than IPP only when the

Contracting Officer authorizes alternate procedures in writing in accordance with HHS procedures.

d. If alternate payment procedures are authorized, the Contractor shall include a copy of the Contracting Officer's written authorization with each payment request.

C.1.1.2 HHSAR 352.370-75 Key Personnel (DEC 2015)

The key personnel specified in this contract are considered to be essential to work performance. At least 30 days prior to the contractor voluntarily diverting any of the specified individuals to other programs or contracts the Contractor shall notify the Contracting Officer and shall submit a justification for the diversion or replacement and a request to replace the individual. The request must identify the proposed replacement and provide an explanation of how the replacement's skills, experience, and credentials meet or exceed the requirements of the contract (including, when applicable, Human Subjects Testing requirements). If the employee of the contractor is terminated for cause or separates from the contractor voluntarily with less than thirty days’ notice, the Contractor shall provide the maximum notice practicable under the circumstances. The Contractor shall not divert, replace, or announce any such change to key personnel without the written consent of the Contracting Officer.

The contract will be modified to add or delete key personnel as necessary to reflect the agreement of the parties.

Key Personnel:

1. Project Manager

2. Chief Engineer

3. Stationary Engineer (Lead)

4 Janitorial (Lead)

5. Landscaping/Ground Maintenance (Lead)

C.2 FDA Clauses

C.2.1 Invoice Submission - FDA Electronic Invoicing and Payment Requirements - Invoice Processing Platform (IPP) (Jan 2022)

a. All Invoice submissions for goods and or services must be made electronically through the U.S. Department of Treasury's Invoice Processing Platform System (IPP).

http://www.ipp.gov/vendors/index.htm

b. Invoice Submission for Payment means any request for contract financing payment or invoice payment by the Contractor. To constitute a proper invoice, the payment request must comply with the requirements identified in FAR 32.905(b), "Content of Invoices" and the applicable Payment clause included in this contract, or the clause 52.212-4 Contract Terms and Conditions - Commercial Items included in commercial items contracts. The IPP website address is https://www.ipp.gov

c. 1. The Agency will enroll the Contractors new to IPP. The Contractor must follow the IPP registration email instructions for enrollment to register the Collector Account for submitting invoice requests for payment. The Contractor Government Business Point of Contact (as listed in SAM) will receive Registration email from the Federal Reserve Bank of St. Louis (FRBSTL) within 3 - 5 business days of the contract award for new contracts or date of modification for existing contracts.

2. Registration emails are sent via email from ipp.noreply@mail.eroc.twai.gov.

Contractor assistance with enrollment can be obtained by contacting the IPP Production Helpdesk via email to IPPCustomerSupport@fiscal.treasury.gov or phone (866) 973-3131.

3. The Contractor POC will receive two emails from IPP Customer Support, the first email contains the initial administrative IPP User ID. The second email, sent within 24 hours of receipt of the first email, contains a temporary password. You must log in with the temporary password within 30 days.

4. If your company is already registered to use IPP, you will not be required to re-register.

5. If the Contractor is unable to comply with the requirement to use IPP for submitting invoices for payment as authorized by HHSAR 332.7002, a written request must be submitted to the Contracting Officer to explain the circumstances that require the authorization of alternate payment procedures.

a. Invoices that include time and materials or labor hours Line Items must include supporting documentation to (1) substantiate the number of labor hours invoiced for each labor category, and (2) substantiate material costs incurred (when applicable).

b. Invoices that include cost-reimbursement Line Items must be submitted in a format showing expenditures for that month, as well as contract cumulative amounts. At a minimum the following cost information shall be included, in addition to supporting documentation to substantiate costs incurred.

c. Labor - include all persons, listing the person's name, title, number of hours worked, hourly rate, the total cost per person and a total amount for this category.

d. Indirect Costs (i.e., Fringe Benefits, Overhead, General and Administrative, Other Indirect)- show rate, base, and total amount.

e. Consultants (if applicable) - include the name, number of days or hours worked, daily or hourly rate, and a total amount per consultant.

f. Travel - include for each airplane or train trip taken the name of the traveler, date of travel, destination, the transportation costs including ground transportation shown separately and the per diem costs. Other travel costs shall also be listed.

g. Subcontractors (if applicable) - include, for each subcontractor, the same data as required for the prime Contractor.

h. Other Direct Costs - include a listing of all other direct charges to the contract, i.e., office supplies, telephone, duplication, postage; and

i. Fee - amount as allowable in accordance with the Schedule and FAR 52.216-8 if applicable.

j. Contractor is required to attach an invoice log addendum to each invoice which shall include, at a minimum, the following information for contract administration and reconciliation purposes:

(a) list of all invoices submitted to date under the subject award, including the following:

(1) invoice number, amount Direct, & date submitted (2) corresponding payment amount & date received

(b) total amount of all payments received to date under the subject contract or order (c) and, for definitized contracts or orders only, total estimated amounts yet to be invoiced for the current, active period of performance.

k. Payment of invoices will be made based upon acceptance by the Government of the entire task or the tangible product deliverable(s) invoiced.

Payments shall be based on the Government certifying that satisfactory services were provided, and the Contractor has certified that labor charges are accurate.

l. If the services are rejected for failure to conform to the technical requirements of the task order, or any other contractually legitimate reason, the Contractor shall not be paid, or shall be paid an amount negotiated by the CO.

m. Payment to the Contractor will not be made for temporary work stoppage due to circumstances beyond the control of U.S. Food and Drug Administration such as acts of God, inclement weather, power outages, and results thereof, or temporary closings of facilities at which Contractor personnel are performing.

This may, however, be justification for excusable delays.

n. The Contractor agrees that the submission of an invoice to the Government for payment is a certification that the services for which the Government is being billed, have been delivered in accordance with the hours shown on the invoices, and the services are of the quality required for timely and successful completion of the effort.

o. Questions regarding invoice payments that cannot be resolved by the IPP Helpdesk should be directed to the FDA Employee Resource and Information Center (ERIC) Helpdesk at 301-827-ERIC (3742) or toll-free 866-807-ERIC (3742); or, by email at ERIC@fda.hhs.gov. Refer to the Call-in menu options and follow the phone prompts to dial the option that corresponds to the service that's needed. All ERIC Service Now Tickets will either be responded to or resolved within 48 hours (2 business days) of being received. When emailing, please be sure to include the contract number, invoice number and date of invoice, as well as your name, phone number, and a detailed description of the issue.

C.2.1.1 Government Points of Contact TBD

1. Contracting Officer Representative Telephone: tbd Email: tbd

2. Contract Specialist

Patricia Natividad, Contract Specialist Telephone: (301)-796-8919 Email: Patricia.Natividad@fda.hhs.gov

3. Contracting Officer

Patricia Natividad, Contracting Officer (CO) Email: Patricia.Natividad@fda.hhs.gov

PART D – CONTRACT DOCUMENTS, EXHIBITS, AND ATTACHMENTS.

STATEMENT OF WORK

STATEMENT OF WORK

D.1 BACKGROUND

The FDA is a regulatory agency that conducts inspections of consumer products, including food, drugs, medical devices, and biological products. The LOSDO components also investigate consumer complaints, educate the public on FDA initiatives, and perform other activities to enforce and enhance compliance with the Food, Drug and Cosmetic Act. The LOSDO/PFFL/PMML is a multi-functional regional laboratory, performing predominantly import work in the areas of microbiology, entomology, and organoleptic analysis, chemical indices of decomposition, pesticide chemistry, human drug chemistry and medical device evaluation.

The Operations and Maintenance services described in the Statement of Work (SOW) shall be performed at 19701 Fairchild, Irvine, California 92612.

D.1.1 SCOPE

The Contractor shall provide all personnel, equipment, tools, materials, supervision, and other items deemed necessary to perform the full range of Operations and Maintenance (O&M) services, as defined in this Statement of Work (SOW) and in accordance with all applicable Federal, State, and local laws, regulations, codes, technical manuals, manufacturer’s guidelines and FDA Policies and directives to maintain the facility in optimum operating condition. The Contractor shall perform to the standards in this contract. The Contractor is responsible to maintain equipment in a manner to ensure any applicable warranty remains valid. The Contractor shall operate and maintain the LOSDO/PFFL/PMML 7 days a week. Normal Government business hours are 6:00am to 6:00pm Pacific Time (PT). Some repairs or maintenance may be required to occur after normal duty hours and shall be coordinated and scheduled with the COR. Further, all non-emergency repairs or preventive maintenance shall be coordinated with the COR three weeks in advance to be scheduled around research activities. The COR may require the Contractor to submit applicable certification (i.e., boiler operator certificate, HVAC certificate, and/or building engineer certificate, Building Automated System (BAS) certification prior to performing any work deemed to be outside of normal preventive maintenance functions.

This SOW is a statement of the minimum level of work and services that are to be provided in certain areas under this contract; not intended to be, nor shall be construed as, limiting specifications or requirements. At a minimum, the Contractor will be required to take all steps and measures that would be taken by a prudent building owner to maximize the life expectancy of the property.

D.1.2 GENERAL SPECIFICATIONS

1.2.1 The selected Contractor shall provide documentation proving success in operating and maintaining a facility of comparable square footage and complexity as the LOSDO/PFFL/PMML within the last three years. The Contractor shall show the ability to operate a scientific research facility with varying disciplines.

The Contractor shall demonstrate this ability through experience in BLS-2 experience, and also operational knowledge of Biosafety lab requirements i.e. (proper PPE, ventilation requirements and other such items). The Contractor shall maintain the Clean Industry Management Standards (CIMS) certification as it pertains to building operations and maintenance. The contractor shall also show knowledge and experience in a laboratory specific or similar to the LOSDO/PFFL/PMML.

1.2.2 Key Personnel:

The Contractor shall provide a PM that shall be responsible for the performance of work.

The Project Manager, Chief Engineer, Stationary Engineer (Lead), and Janitor/ Lead, Landscaping/Ground Maintenance (Lead) shall be designated to the CO in writing.

A key personnel member shall be contactable and then available to respond to after hour.

The Government will provide space for Key Personnel. The Government has the right to refuse any proposed key personnel that does not meet the stated requirements or have the experience of the complexity of a facility similar to the LOSDO/PFFL/PMML facility in Irvine.

1.2.3 OEM issued equipment/deliverables needed to maintain building operation such as

(BACnet, Laptop, or special tools), the Key Personnel shall ensure all item are maintained and accounted for.

1.2.4 Unsatisfactory Work. The Contractor shall correct all unsatisfactory work that falls within the requirements of the SOW.

1.2.5 Contractor employees shall observe and comply with all FDA rules and regulations concerning general employee conduct as it may from time to time be published. The Government will provide these documents to the Key Personnel.

1.2.6 Loitering. Contractor employees shall not loiter around the facility during off-duty hours.

1.2.7 Contractor Employees. The Contracting Officer has the authority to restrict the employment under the contract of any Contractor employee, or prospective employee, who is identified as a potential threat to the health, safety, security, general wellbeing or operational mission of the facility and its population. The Contracting Officer may require the Contractor to remove any employee from the job site who is found objectionable by the Government. The removal from the job site of such persons shall not relieve the Contractor of the requirement to provide replacement personnel to perform adequate and timely services.

1.2.8 Medical Screening. The Government shall require medical screening of Contractor personnel, at Contractor expense, to ascertain whether employee(s) has/have been using controlled substances.

1.2.9 Uniforms. All Contractor employees shall present a neat appearance and be easily recognized. All employees (except for Key Personnel) shall wear Contractor issued distinctive clothing bearing a distinguishable emblem or patch. The Contractor shall provide 3 shirts, 3 pants, and 1 pair of shoes per person. The clothing shall be approved by the COR. The Contractor is expected to have its employees whether Service Contract Act employees, and as its sub-contractors in uniform within 30 calendar days from the date of being hired. Any lost or stolen uniforms shall be reported immediately to the COR and CO.

1.2.10 Certificate and Licensing. The Contractor shall ensure that all operating engineers operating the main utility equipment individually possess and maintain a valid California Building Operators Certification (BOC) .

1..2.11 The Contractor shall not employ any person who is an employee of the United States

Government.

1..2.12 Technical personnel shall have journeymen level experience in the maintenance and in the operation of utility systems of the type used at LOSDO/PFFL/PMML in Irvine, CA.

Experience will be validated through an apprenticeship program certificate or confirmed work experience.

1.2.13 Supervisory personnel shall be experienced in the administration, scheduling, and coordination of a work force for the maintenance of facilities such as the

LOSDO/PFFL/PMML.

1.2.14 Employees furnished under this contract shall be experienced in the maintenance of equipment and systems of the type currently in use at the LOSDO/PFFL/PMML;

Contractor personnel shall be able to read, write, speak, and understand English.

1..2.15 The Contractor shall ensure appropriate staff participation in any applicable training scheduled by the Government during normal working hours at the LOSDO/PFFL/PMML.

1.2.16 The COR shall review the resumes of all proposed key personnel prior to being employed under this contract and make recommendations to the Contracting Officer.

1.2.17 The Contractor shall immediately notify the COR and Contracting Officer in writing via email when a decision to terminate any key personnel has been made.

D.1.3 QUALITY CONTROL.

1.3.1 The Contractor shall establish and maintain a complete Quality Control Plan to assure the requirements of the contract are provided as specified. Electronically submit in .pdf format the approved Contractor's Quality Control Plan shall be provided to the Contracting Officer and COR no later than 120 days after the effective date of the contract. An updated copy shall be provided to the Contracting Officer and COR as changes occur. The plan shall include, but is not limited to, the following:

a. An inspection system covering all the services or requirements in the SOW. It shall specify the areas to be inspected on both a scheduled or unscheduled basis, how often inspections will be accomplished, and the title of the individual(s) who will perform the inspection.

b. The methods for identifying and preventing defective or unsatisfactory work in the quality of service performed before the level of performance becomes unacceptable.

c. On-site records of all inspections conducted by the Contractor and necessary corrective action taken. This documentation shall be made available to the Government at all times.

d. The Contractor shall assign the role of Quality Control Manager to personnel, which may be a collateral duty. The Quality Control Manager shall monitor functions and respond to user problems.

D.1.4 QUALITY ASSURANCE.

1.4.1 The Government will evaluate the Contractor's performance under this contract. This surveillance does not relieve the Contractor of its own quality control responsibility. The Government will record all surveillance observations. When an observation indicates defective performance or unsatisfactory work, the Contractor's Key Personnel shall initiate the observation, review, and correct any deficiencies sign and date when complete.

1.4.2 Methods of Quality Assurance Evaluation. Five methods of quality assurance evaluation will be used. One or several may be used to evaluate the Contractor's performance for any given service requirement. The five methods are:

a. Random Sampling. Surveillance based on random sampling is designed to evaluate some part, but not all, of the contract requirement being monitored. This method, based on statistical theory, estimates the Contractor's overall level of performance for a given contract requirement. Using random sampling, any occurrence of a contact requirement is as likely to be evaluated as any other occurrence.

b. Planned Sampling. Evaluation by planned sampling, like evaluation by random sampling, is designed to inspect some part but not all of the contract requirements being monitored.

c. 100% Inspection. One Hundred percent inspection is that evaluation method that requires total, or 100%, inspection of a contract requirement.

d. Validated Complaints. This method is based on customer awareness. Customers monitor the service provided by the Contractor. When there is a case of poor or nonperformance, the COR will be notified. Upon notification, the Government will investigate the report and if it is found to be valid, it will be documented.

e. Unscheduled Inspection. Unscheduled inspection is, as the name implies, impromptu evaluation of contract performance by authorized Government personnel.

D.1.5 STATUTORY AND ACTUAL DAMAGES.

Mandatory deductions are addressed elsewhere related to the value of services not received for work not performed or defectively performed. The Contractor shall additionally be subject to deductions for damages consequently incurred by the Government as a result of the Contractor's nonperformance or defective performance. These deductions may apply in case of total default, partial default, or when a specific contract requirement is not performed or, when determined by the Contracting Officer is unsatisfactorily performed.

1.5.1 Actual Damages.

When the Contractor's failure to perform any requirement of this contract causes the full or partial failure of any ongoing experiment or research program, the Contractor shall be liable to the Government for all personnel and material cost of the portion of the experiment or research program that failed. As used in this paragraph, "failure" means that progress is disrupted to the extent that additional personnel or material resources shall be expended to bring the experiment or program back up to the level it was at immediately prior to the incident that caused its disruption.

1.5.2 Property Damage.

The Contractor shall be responsible for damages to the FDA property and its contents that, in the opinion of the CO, result from negligence or non-compliance with this SOW. In such cases, the Contractor shall be notified in writing by the CO and the Contractor shall be given the opportunity to correct the damaged property at its expense within a timeline acceptable to the CO. If the Contractor fails to correct the damage under the terms agreed to with the CO, or otherwise fails to perform, the CO will determine a deduction.

D.1.6 PERFORMANCE.

1.6.1 Performance Evaluation Meetings. The Key Personnel may be required to meet with the

COR and/or Contracting Officer as needed to discuss Contractor performance. The Contractor provided written minutes of these meetings shall be signed by the Key Personnel and COR.

1.6.2 Unsatisfactory performance is the Contractor’s failure to perform any of the requirements set forth in this SOW. In such cases, the CO shall notify the Contractor in writing and the Contractor shall be given the opportunity to correct unsatisfactory performance within a timeline acceptable to the CO. If unsatisfactory performance or failure to perform remains, the CO reserves the right to exercise options specified in 1.7 to recapture the Government’s losses, in addition to other remedies.

D.1.7 ASSESSMENT OF COSTS

1.7.1 Assessment of Costs. Cost assessed to the Contractor will be based on the cost of the fines or penalties assessed to the Government and the Government material and personnel costs lost due to Contractor-induced errors. Proposed assessments against the Contractor will be fully documented by the Government and forwarded to the Contractor for explanation of any extenuating factor, which may apply. The Contracting Officer will review the Contractors reply and make the final determination regarding any charges to be assessed.

1.7.2 The Contractor shall be subject to deductions for damages consequently incurred by the

Government as a result of the Contractor's nonperformance or defective performance.

These deductions may apply in case of total default, partial default, or when a specific contract requirement is not performed or, when determined by the CO, is unsatisfactorily performed.

1.7.3 Deductions nonperformance or defective performance. The CO reserves the right to take deductions from the Contractor’s monthly invoice for unsatisfactory work in either of the following methods: Multiply the appropriate hourly rate from the Contractor’s approved price proposal by the amount of unsatisfactory work or using the cost incurred by the Government to accomplish the service by other means.

D.1.8 WORK MANAGEMENT

1.8.1 General. The Contractor shall provide the Contracting Officer (within 30 days after contract of award date) a comprehensive Work Management Plan which shall be the basis for receipt of work, planning, estimating, material acquisition, facility inspection, work assignment, and scheduling. This plan shall facilitate accomplishment of all items of work necessary to accomplish the various tasks described in this SOW; and shall provide supervision, recording, and evaluation of work performance to ensure timeliness, completeness, and efficiency. It shall be developed in accordance with the following requirements:

a. Maintenance guidelines, manufacturer's recommendations, and standards

b. Federal, State and Local Codes, including Environmental Safety & Health

c. Requirements set forth in individual sections of this SOW

d. Industry standards

e. A complete explanation of the Contractor's operating procedures including a

Maintenance recording log.

f. An operations plan describing how the buildings, its equipment and life safety systems will meet most efficiently operated and maintained.

g. Staffing Plan to include:

1) Organization Chart, completely outlining personnel organization and schedules

2) Job titles

3) Position Descriptions and Responsibilities

4) Procedures for filling unexpected absences of critical personnel

5) Hiring Plan to fill personnel vacancies and a complete plan for hiring and training personnel for initial contract performance as well as vacancies that occur during the life of the contract. This plan shall outline the Contractor's ability to assure that all personnel will be available for work no later than the effective date of the contract. It shall also describe the qualifications of employees to be used on the project with detailed information concerning certifications, licenses and the scheduling of health and physical examinations if required by the contractors. The Contractor shall be responsible for the cost of all certifications, licenses and health and physical examinations throughout the life of the contract.

1.8.2 General personnel Management Policies

A reporting method including provisions for ensuring all logs, records and charts be available to the COR during regular working hours. A detailed description of methods of operational testing, measuring recording and reporting of operating data to include operating logs. An explanation of procedures for frequencies of operator inspections and services (e.g., tour list under O&M and a periodic schedule). A written explanation of emergency response procedures. A written explanation of the type of computerized maintenance management system (CMMS) to be used, and the type of documents it will generate to comply with various work order requirements. The system shall be accessible for the Government’s review at all times and the Contractor shall provide training on the system as requested by the COR. The Contractor shall also respond and track incidents from the FDA ERIC Call System and the FDA CMMS Archibus system for generating Preventative Maintenance procedures. A reliability centered maintenance program with a preventive maintenance and predictive maintenance plan for all items and components to be maintained. This plan shall list each item or component and shall, at a minimum contain the following:

a) A description of inspection and maintenance techniques.

b) Personnel scheduled for performance.

c) System shutdown and coordination requirements, three (3) weeks advance notification prior to shut down, except for emergencies.

d) Preventive maintenance inspections, services, and frequencies, with recording methodology, using reliability maintenance centered program. The Contractor shall also use the FDA ERIC Call Center system to respond to maintenance related issues.

e) A description of the Contractors proposed method(s) of preventive maintenance control, including the specific time required for the Contractor to correct unsatisfactory work.

f) Demonstrate that documentation for this plan is being accurately and currently maintained at all times. The plan shall provide methodology for changes in equipment inventory based on approved predictive maintenance techniques and for submitting such updates to the Government for approval. In accordance with this requirement, any proposed changes to equipment inventory shall be presented to the COR in writing within fifteen (15) calendar days after the Contractor identifies the necessity for each change.

g) An explanation of the manner in which materials are acquired and purchased.

h) An inventory listing of materials to be kept at the facility to accomplish recurring or routine service and repair work (e.g., light bulbs, tubes, ballasts, flush kits, fuses, solvents, cleaners, rags, filters, etc.…) to include an Inventory list of environmentally preferable supplies, products, and equipment shall be provided upon contract award and updated as necessary.

i) The Contractor shall provide an electronic weekly work schedule to the COR upon request.

The schedule shall include all work requests and orders. The Contractor shall schedule work requests around the Fire/life safety, Security, Research continually protecting the environment. Schedules shall indicate location of work, by building or area. The COR may review the work schedule and may direct the Contractor to revise its work schedule to meet specific Government need to minimize disruption to normal building and operational function.

j) The expenditures of resources shall be recorded on a daily basis, to include man-hours by individuals' names and craft, specific work tasks accomplished, and material expended. The COR reserves the right to review this record at anytime.

k) The Contractor shall be designated as a point of contact for all Contractors entering the facility under other Government building repair or renovation projects. This ensures continuity of overall services and provides a general awareness of building projects to the Contractor. Contractor shall participate in such projects and advise the COR if there is an anticipated conflict or other impact on normal building operations.

l) The Contractor shall be responsible for coordinating any interruption of utility service or equipment with the COR in conjunction with work performed by any Government Contractor. The interruption of service shall be scheduled in advance and approved by the COR to minimize the length of time of the interruption and to minimize its effect on the operations in areas being disrupted. The Contractor shall post signs at all affected areas of the outage to pre-announce such outages or breaks in services.

1.8.3 The Contractor shall submit the following reports/deliverables:

A. Monthly Status and Preventative Maintenance reports.

The Monthly Status and Daily Work sheets report shall be delivered to the CO and COR covering the previous full month, delivered by the 10th of the month via email. The monthly status and daily worksheet reports shall include at a minimum:

1) A record of maintenance performed on all equipment

2) Vendors and sub-contractor services

3) Weekly water test and analysis reports and monthly water test of all utility systems requiring specific water chemistry

4) Summaries of Quality Control reports

5) Equipment certifications (such as Boilers and other equipment needing certification)

6) Identify equipment requiring replacement of parts during the period and spare parts utilized

7) The weekly reports shall include:

8) Any ongoing tasks/repair that require daily reports/update until completion

9) Identified service orders

10) Weekly Preventive Maintenance

11) Daily building status such as building-wide temperature. etc.

D.1.9 PHYSICAL SECURITY

1.9.1 The Contractor shall be responsible for safeguarding all Government property provided for

Contractor use. This includes, but is not limited to, Government Equipment. At the close of each work period, Government facilities, equipment and materials shall be secured. The Contractor shall take all necessary action needed to protect the Government's property against catastrophic events such as major or unusual weather conditions or utility outages.

The Contractor shall designate a Security Representative to coordinate or otherwise manage security requirements in accordance with FDA requirements. The Contractor shall ensure the employees complete all security training required.

1.9.2 Controlled Entry. Entrance into the Irvine Facility is controlled through the guard station entrance. Contractor visitors are required to sign in and out at the entrance and shall be escorted by a designated Representative. Permanent workforce personnel with a valid FDA Contractor ID Badge are not required to sign in or out during the normal hours of operation for the Government. The Contractor shall also provide the COR with a roster of visitors at a minimum one duty day in advance of the expected arrival. The Contractor shall comply with all applicable FDA Security protocols of this contract. Pending an approved background check, the Government will provide picture ID badges to be renewed per FDA policy, for security purposes. The Contractor and its employees shall comply with all security procedures for access to the grounds. Badges shall be displayed at all times. In addition, the

Contractor shall comply with the Security Clearance Requirements Clause specified, FDA 1335 Personnel Security Clearance Requirement.

1.9.3 Key Control. The Contractor shall establish and implement a procedure for ensuring that all keys and lock combinations issued to Contractor personnel by the Government are not lost or misplaced and are not used by unauthorized persons. The Contractor is responsible to keep all mechanical, electrical rooms, wire closets locked at all times.

Keys issued to the Contractor shall not be duplicated; combinations shall not be disseminated beyond a "need to know" basis. The Contractor shall provide a list to the COR of personnel that have been issued keys and shall update the list quarterly and submit the update to the COR via email.

The Contractor shall report loss of a key or compromise of a combination immediately to the

COR. The Government shall immediately replace all keys lost by the Contractor. Existing locks will be replaced; the direct cost of which will be charged to the Contractor. Cost of replacing combination locks as a result of Contractor-caused compromise of combination will be assessed to the Contractor via determination by the CO.

D.1.10 ENERGY CONSERVATION

1.10.1 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. The Key Personnel shall ensure it remains aware of, and takes action 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 twice a year 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 prior to implementation.

1.10.2 Water. Domestic hot water temperatures shall not exceed 140 degrees Fahrenheit at the point of use. All other hot water systems shall be operated at temperatures identified by the COR.

1.10.3 Electricity. Inside lights, that are not controlled by motion sensors 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 when not needed.

1.10.4 Steam. Steam traps shall not be bypassed. Traps shall be maintained in good operating order to prevent the bypass of live steam into the condensate system.

1.10.5 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.

D.1.11 SAFETY HEALTH & ENVIRONMENTAL MANAGEMENT

1.11.1 The Contractor shall establish an accident prevention, safety program. The safety program shall include submittal of a workplace safety plan within 30 days after contract award.

The safety plan and program shall 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 plan(s) shall be submitted to the Contracting Officer for approval 30 days after contract is award.

Pandemic plan shall be included in the Safety program and Safety plan.

1.11.2 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.

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

1.11.4 The Government reserves the right to investigate accidents involving Contractor personnel. The Contractor shall immediately report to the Government both the CO and COR 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.

1.11.5 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). 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), American National Standards Institute (ANSI), etc... Any conflicting instructions between these shall be brought to the COR for resolution.

1.11.6 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.

1.11.7 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 0 and P.

1.11.8 All solid waste materials defined in Title 40 of the Code of Federal Regulations, Part 243, Requirements and Recommended Procedures 243.200-1 Requirement, 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. Employee Training. The Contractor shall provide the COR with annual reports of employee(s) training certifications via email.

1.11.9 The Contractor shall maintain an accurate file of Material Safety Data Sheets (MSDS) 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 Material Safety Data Sheets, (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 via email.

1.11.10 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.

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

1.11.12 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.

1.11.13 The Contractor will 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. The Fire Drill Schedule shall be provided to the COR.

1.11.14 No later than 30 days from date of contract award, the Contractor shall develop and submit a written Exposure Control Plan to the COR designed to eliminate or minimize contractor employee exposure to blood borne pathogens. 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.

Clothing which becomes contaminated with blood or other bodily fluids during activities should 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.

1.11.15 Pregnant Employees should review safe work procedures with Safety and Health Office

Personnel.

1.11.16 Contractor employees shall report all injuries, no matter how slight, to the Contractor Key

Personnel. Injuries resulting from equipment (i.e., chemical splashed in the eye, cuts from glass in the trash, etc.) should also be reported to the CO and 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 CO and COR within 24 hours.

1.11.17 Cardiopulmonary Resuscitation (CPR) training shall be completed within 30 calendar day after award of Contract. Also, complete training for all new hires for CPR training within 30 calendar days of hiring.

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

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

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

a. Boiler plant safety devices, relief valves, safety valves, boiler safety devices, Boiler Emissions (AQMD) to include annual inspection and tuneup, and cut offs -- Annually

b. Fire alarm system – Annually by a certified independent contractor

c. Fire Extinguisher inspection -- Visual inspection monthly and annual maintenance reports as specified in 29 CFR, Part 1910.157(e).

d. High voltage Switchgear and Transformers - As required (every three years) in accordance with the National Electrical Testing Association by a company independent of the Contractor.

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

f. Pressure Vessel Certification- As required by Federal, State, and local regulations.

Performed by a company independent of the Contractor.

g. The Contractor shall provide OSHA Hazard Communication training and provide proof of completion 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.

h. The COR will be responsible to inform the Contractor of:

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

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

1.11.21 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.

1.11.22 The Contractor shall comply with all Environmental Protection Agency (EPA) requirements that are necessary to the operation of the facility. These requirements change periodically requiring the contractor to stay abreast of the requirements.

D.1.12 HOURS OF OPERATION

Addendum to the Holiday hours/non-regular hours: LOSDO/PFFL/PMML is a 24-hour complex, and the Contractor shall operate the complex accordingly.

1.12.1 Normal Hours. The normal hours of Government operation will be 6:00 a.m. to 6:00 p.m.

Pacific Time, Monday through Friday. The Contractor shall maintain customer service hours throughout normal working hours.

1.12.2 The Contractor shall provide personnel as needed to meet specific deadlines, or emergency or urgent situations.

1.12.3 The Contractor is required to provide the same service on National Holidays that is provided during normal working hours.

1.12.4 The Contractor shall provide maintenance personnel, and other appropriate personnel to ensure uninterrupted service in and around FDA LOSDO/PFFL/PMML facilities. The Contractor shall respond to emergency conditions by stabilizing, then correct the affected critical equipment, and critical environmental conditions.

D 1.13 LOST AND FOUND PROPERTY

1.13.1 When any material is found which appears to have been lost, abandoned, or for some unknown reason is not on record, the Contractor shall secure the material and report the finding to the COR.

1.13.2 Any item of personal (individual) property or currency either lost or found by Contractor personnel shall be reported to the COR.

1.13.3 The Contractor is advised that any lost or abandoned property by an employee on a

Federal installation in the performance of work is considered to belong to the Government. However, lost or abandoned property will be returned on request of the owner when the owner provides adequate proof of ownership.

1.13.4 The…