DRAFT_Attachment I - Above Standard Equipment IDIQ Statement of Work.pdf

FOOD AND DRUG ADMINISTRATION

The Office of Facilities Engineering and Mission Support Services (OFEMS) Division of Operations Management and Community Relations (DOMCR)

Facilities Maintenance & Operations Branch (FMOB)

Performance Work Statement (PWS)

Preventative Maintenance of Above Standard Equipment at the FDA White Oak Campus

DRAFT Date: 15 May 2025 Version Number: 0.6

Contents

1. BACKGROUND

2. APPLICABLE DOCUMENTS

2.1. SPECIFICATIONS

2.2. STANDARDS AND GUIDELINES

2.3. INDUSTRY/INSTITUTIONAL DOCUMENTS

3. SCOPE

4. PERFORMANCE DETAILS

4.1. CONTRACT TYPE

4.2. PERIOD OF PERFORMANCE

4.3. PLACE OF PERFORMANCE

4.4. HOUR OF OPERATIONS

4.4.1. INCLEMENT WEATHER

4.4.2. NOTICE TO THE GOVERNMENT OF DELAYS

5. TASKS

5.1. PROGRAM PLANNING AND MANAGEMENT

5.1.1. PROJECT MANAGEMENT PLAN ......................... Error! Bookmark not defined.

5.1.2. PROGRAM MANAGEMENT REPORTING

5.1.2.1. LOGS AND RECORDS ........................................ Error! Bookmark not defined.

5.1.2.2. EQUIPMENT MAINTENANCE REPORT AND CERTIFICATIONS ........ Error!

Bookmark not defined.

5.1.3. OPERATIONS MANAGEMENT MANUAL

5.1.4. COMMUNICATIONS PLAN

5.1.5. RISK MANAGEMENT PLAN ................................. Error! Bookmark not defined.

5.1.6. FINANCIAL MANAGEMENT PLAN .................... Error! Bookmark not defined.

5.1.7. RESOURCE MANAGEMENT PLAN ..................... Error! Bookmark not defined.

5.1.8. TRANSITION ACTIVITIES AND PLANNING ..... Error! Bookmark not defined.

5.1.8.1. TRANSITION-IN .................................................. Error! Bookmark not defined.

5.1.8.2. TRANSITION-OUT .............................................. Error! Bookmark not defined.

5.2. OPERATIONS AND MAINTENANCE (O & M)

5.2.1. CUSTOMER NOTIFICATION

5.2.2. WORK ORDERS

5.2.2.1. PROCESS AND MANAGE WORK ORDER

5.2.2.2. WORK ORDERS

5.2.2.3. SERVICE CALLS

5.2.2.4. EMERGENCY RESPONSE PROCEDURES

5.2.2.4.1. Emergency Work Orders ....................................... Error! Bookmark not defined.

5.2.2.5. CLEANING

5.2.3. PREVENTATIVE MAINTENANCE

5.2.3.1. PREVENTATIVE MAINTENANCE (PM) PLAN

5.2.3.2. PREVENTATIVE MAINTENANCE RECORDS

5.2.3.3. PREVENTATIVE MAINTENANCE SCHEDULE

5.2.3.4. BSL-3, ISO-17025, & AAALAC MAINTENANCE

5.2.4. PROACTIVE MAINTENANCE

5.2.5. INVENTORY

5.2.6. PARTS MANAGEMENT

5.3. REPAIRS & EQUIPMENT MANAGEMENT

5.3.1. INCIDENTAL REPAIRS

5.3.2. MINOR REPAIRS

5.3.3. MAJOR REPAIRS

5.3.4. BSL-3, ISO-17025, & AAALAC REPAIRS

5.4. EQUIPMENT CERTIFICATIONS AND WORK CLEARANCES

5.4.1. CERTIFICATIONS

5.4.1.1. BIOLOGICAL SAFETY LEVEL 3 (BSL-3)

5.4.1.2. INTERNATIONAL ORGANIZATION FOR STANDARD (ISO) 17025

5.4.1.3. ASSOCIATION FOR ASSESSMENT & ACCREDITATION FOR

LABORATORY ANIMAL CARE INTERNATIONAL (AAALAC)

5.4.1.3.1. WATER TESTING

5.4.1.4. WARRANTY

5.4.2. WORK CLEARANCES

5.4.2.1. MEDICAL SCREENING

5.4.2.2. UNIFORMS

5.4.2.3. PROTECTIVE CLOTHING

5.4.2.4. TRAINING, CERTIFICATIONS AND LICENSING

5.4.2.5. ENVIRONMENT, BUILDING AND SPACE

6. MANPOWER REQUIREMENTS & LABOR CATEGORY DESCRIPTIONS

6.1. KEY PERSONNEL

6.2. LABOR CATEGORY DESCRIPTIONS

6.3. STAFF PLANNING AND RETENTION

7. GENERAL REQUIREMENTS

7.1. MATERIALS, EQUIPMENT & LOCATIONS

7.1.1. GOVERNMENT FURNISHED PROPERTY

7.1.1.1. EQUIPMENT

7.1.1.2. EQUIPMENT ACCOUNTABILITY

7.1.1.3. FORMS AND PUBLICATIONS

7.1.2. CONTRACTROR-ACQUIRED PROPERTY

7.1.3. FACILITIES

7.1.3.1. CONTROLLED ENTRY

7.1.3.2. RESTRICTED USE OF GOVERNMENT FACILITIES AND PROPERTY

7.1.3.3. KEYS

7.1.4. WARRANTY

7.2. BADGES, PHYSICAL SECURITY, & SAFETY REQUIREMENTS

7.3. OPERATIONAL SAFETY & HEALTH

7.3.1. LOCAL, STATE AND FEDERAL SAFETY & HEALTH REQUIREMENTS

7.3.2. CHEMICAL HAZARDS

7.3.3. FIRE SAFETY

7.3.4. SAFETY DATA SHEETS (SDS)

7.3.5. MARKINGS, GUARDS AND BARRIERS

7.3.6. STORAGE AND DISPOSAL

7.3.7. OCCUPANT EMERGENCY EVACUATION PLAN

7.3.8. EXISTING DRAWING AND TECHNICAL DATA

8. ADMINISTRATIVE REQUIREMENTS

8.1. OTHER DIRECT COSTS

8.2. DELIVERABLES

8.2.1. CRITERIA FOR ACCEPTANCE OF DELIVERABLES

8.3. TRAVEL POLICY

8.4. SECURITY AND CONFIDENTIALITY

1. BACKGROUND

The U.S. Food and Drug Administration (FDA) White Oak Campus, located at 10903 New Hampshire Avenue, Silver Spring, Maryland, consists of 710 acres of developed land in addition to 130 acres of land planned for continued development. The campus is comprised of state-of-the-art laboratories, office buildings and support facilities. As demonstrated within Attachment I – Site List, the FDA houses over 4,400 piece of specialty equipment. Subsequently, the purpose of this requirement is to obtain Contractor specialty equipment maintenance and repair services to support FDA’s mission to protect public health by ensuring laboratory specialty equipment located at the White Oak Campus, are maintained and repaired according to local, state, federal and industry standards and regulations (i.e. including BSL3, ISO and AAALAC standards).

This Statement of Work SOW) seeks to establish a new IDIQ contract to provide equipment service/support to over 4,400 pieces of specialty equipment to include additional locations contained in the Site List (see Attachment 1).

2. APPLICABLE DOCUMENTS

The Contractor shall comply with the following applicable documents. Additional applicable documents may be listed in individual TOs. The Contractor shall comply with FDA security, privacy and records management policies, directives, handbooks, and guidelines. The Contractor shall reference the most recent versions of all applicable documents as approved by the COR.

2.1. ATTACHMENTS

1. Site List

2. List of Acronyms

2.2. SPECIFICATIONS

3. Biosafety in Microbiological and Biomedical Laboratories (BMBL)

2.3. STANDARDS AND GUIDELINES

1. 29 CFR 1910.144 – Safety Color Code for Marking Physical Hazards

2. 29 CFR 1910 Subpart O – Machinery and Machine Guarding

3. 29 CFR 1910 Subpart P – Hand and Portable Powered Tools and Other Hand-Held

Equipment

4. 40 CFR – Protection of Environment

5. Health and Human Services (HHS) Occupation Safety and Health Manual

6. Occupational Safety and Health Administration (OHSA)

7. National Safety Code (NSC)

8. American Society of Heating, Refrigeration and Air Conditioning Engineers (ASRA)

9. Building Officials and Code Administrators (BOCA) and Environmental Protection Agency (EPA)

10. Clean Air Act Section 608

11. Bio-Safety Level 3 (BSL3)

12. Association for Assessment and Accreditation for Laboratory Animal Care

(AAALAC)

13. International Organization for Standardization (ISO) 17025.

14. American Association for Laboratory Animal Science (AALAS)

2.4. INDUSTRY/INSTITUTIONAL DOCUMENTS

1. FDA Staff Manual Guide FDA 2620

2. Operations Management Manual

3. SCOPE

The Contractor shall provide FDA with the following services:

1. Program Planning and Management

2. Operations and Maintenance (O&M)

3. Equipment Repairs

4. Equipment Certifications and Work Clearances

5. After Hours Support

6. SiteScan Support (O&M)

This SOW provides general requirements, as specific requirements shall be defined in individual Task Orders (TOs). Requirements described in Section “5.0 – Tasks” are not mutually exclusive for TO requirements. The requirements in Section “5.0 – Tasks” shall apply across multiple service areas.

4. PERFORMANCE DETAILS

4.1. CONTRACT TYPE

This is an Indefinite Delivery Indefinite Quantity (IDIQ) Single-Award contract.

TOs issued against this contract may be fixed price, time and material, or a hybrid of both contract types.

4.2. PERIOD OF PERFORMANCE

The period of performance shall be for a base period of one-year with four one-year option periods.

4.3. PLACE OF PERFORMANCE

The place of performance for tasks under this IDIQ contract will be specified in the individual Task Orders. Locations will be FDA sites primarily located in the eastern United States and set forth in Attachment I, “Metropolitan Area Site List.” However, the Contractor shall primarily perform activities at the White Oak Campus (WO), located at:

10903 New Hampshire Ave, Silver Spring, Maryland 20993

No work shall be performed on Contract sites or outside of the Continental United States

(OCONUS).

Note: Performance under this IDIQ may require travel for the contractor employees. If travel within the domestic United States (CONUS) is required, the contractor is responsible for making all needed arrangements for its employees. Costs incurred for travel will be reimbursed in accordance with the Federal Travel Regulations.

4.4. HOUR OF OPERATIONS

Standard hours of operation are 6:00 a.m. to 6:00 p.m. Eastern Standard Time. The Contractor shall provide full time coverage during the standard hours of operation.

Work at a Government site shall not take place on Federal holidays or weekends unless directed by the CO.

The Government hereby provides notification that Government personnel observe the listed days as holidays:

(1) New Year's Day (7) Labor Day

(2) Martin Luther King's Birthday (8) Columbus Day

(3) President’s Day (9) Veterans' Day

(4) Memorial Day

(5) Juneteenth National Independence Day

(10) Thanksgiving Day

(11) Christmas Day

(6) Independence Day

In addition to the days designated as holidays, the Government observes the following days:

(1) Any other day designated by Federal Statute

(2) Any other day designated by Executive Order

(3) Any other day designated by the President’s Proclamation

Observance of such days by Government personnel shall not be cause for an extension to the delivery schedule or period of performance or adjustment to the price, estimated cost, or fee(s), if any, except as set forth in the contract.

Except for designated around-the-clock or emergency operations, Contractor personnel shall not be able to perform on-site under this contract with FDA on holidays set forth above. The Contractor shall not charge any holiday as direct charge to the contract. In the event Contractor personnel work during a holiday observed by the Contractor other than those above, no form of holiday or other premium compensation will be reimbursed as either a direct or indirect cost. However, this does not preclude reimbursement for authorized overtime work.

In the event the FDA grants administrative leave to its Government employees at the site, on-site Contractor personnel shall also be dismissed if the site is being closed. However, the Contractor shall continue to provide sufficient personnel to perform around-the-clock requirements of critical efforts already in progress or scheduled and shall be guided by the instructions issued by the Contracting Officer or her/his duly appointed representative. In each instance when the site is closed to Contractor personnel as a result of inclement weather, potentially hazardous conditions, explosions, or other special circumstances, the Contractor shall direct its staff as necessary to take actions such as reporting to its own site(s) or taking appropriate leave consistent with its policies.

The cost of salaries and wages to the Contractor for the period of any such site closure shall be a reimbursable item of direct cost under the contract for employees whose regular time is normally a direct charge if they continue to perform on contract work; otherwise, the costs are reimbursable as indirect costs in accordance with the Contractor's established accounting policy.

4.4.1. INCLEMENT WEATHER

In each instance when the site is closed to Contractor personnel as a result of inclement weather, potentially hazardous conditions, explosions, or other special circumstances, the Contractor shall direct its staff as necessary to take actions such as reporting to its own site(s) or taking appropriate leave consistent with its policies. The Contractor shall adhere to guidance from the US Office of Personnel Management (OPM) as posted on www.opm.gov and through their app, OPM Alert, which –provides a real time look at the current operating status for Federal Government offices in the Washington, DC area. After hour will be required regardless of the OPM Alert status.

4.4.2. NOTICE TO THE GOVERNMENT OF DELAYS

In the event the Contractor encounters difficulty in meeting performance requirements, or when the Contractor anticipates difficulty in complying with the contract delivery schedule or completion date, or whenever the Contractor has knowledge that any actual or potential situation is delaying or threatens to delay the performance of this contract, the Contractor shall immediately notify the Contracting Officer and COR in writing, giving pertinent details. This data shall be informational only in character and this provision shall not be construed as a waiver by the Government of any delivery schedule or date, or any rights or remedies provided by law or under this contract.

5. TASKS

Individual Task Orders may encompass more than one functional area listed in Section 5.0.

Additional task details are included to provide greater insight into the potential Task Order http://www.opm.gov/ requirements covered in this PWS. The Program Planning and Management Task Order shall apply across each Task Order awarded under this IDIQ, as the Contractor shall provide program and project management services for all Task Orders.

5.1. PROJECT MANAGEMENT PLAN

The Contractor shall establish and maintain an integrated project management plan. The project management plan shall be the basis for receipt of work, planning, estimating, material acquisition, facility inspection, work assignment, and scheduling. The project management plan shall facilitate accomplishment of all requirements identified herein and shall provide supervision, recording, and evaluation of work performance to ensure timeliness, completeness, and efficiency.

5.1.1. PROGRAM MANAGEMENT REPORTING

The Contractor shall submit MPRs to the FDA Project Manager (PM) and COR no later than the fifth (5th) working day of every month. The MPR shall be submitted in electronic form (i.e. Microsoft Word, Microsoft Project, or Microsoft Excel) as required by the COR.

5.1.2. STATUS MEETINGS

The Contractor shall attend weekly status meetings to discuss the MPR for the given month in detail. The duration of the status meetings shall be no more than 90 minutes in length.

5.1.3. OPERATIONS MANAGEMENT MANUAL

The Contractor shall develop and maintain an operations management manual, which clearly describes how the equipment and life safety systems will be most efficiently operated and maintained. The Contractor shall meet with FDA stakeholders and review the document to capture current FDA equipment service procedures as well as establish the basis for the development of future standard operating procedures. Such meetings are anticipated to take place on a quarterly basis.

5.1.4. TRANSITION ACTIVITIES AND PLANNING

5.1.4.1. Transition-In

The Contractor shall transition and assume the responsibility for activities and duties from the prior Contractor in a manner that does not interrupt or negatively impact FDA’s mission critical operations and activities. The purpose of the transition-in requirement is to provide an orderly transition from the incumbent Contractor. The new Contractor shall work with the incumbent Contractor to affect a smooth and efficient transition of work from one vendor to the other.

5.1.4.2. Transition-Out

The Contractor shall facilitate the transition-out of contracted activities and services to the FDA or, to a follow-on Contractor by the end of the contract period of performance.

The Contractor shall provide transition-out activities, to include, but not be limited to, a transition-out plan, leading technical exchange meetings with the successor to impart knowledge of processes, projects, data, systems, and applications, as well as sustainment activities to meet the task. The Contractor shall ensure the technical exchange meetings shall detail the technology used for their activities. During this period, the Contractor shall ensure no degradation in support provided under the task order. Between the turnover date designated by the COR and the end of the contract period of performance, the outgoing Contractor shall ensure all task order activities are closed out and provide sustainment support to complete the transition.

5.2. OPERATIONS AND MAINTENANCE (O & M)

The Contractor shall conduct operations and maintenance on the following item types:

1. Refrigeration

a. -80° Freezer

b. -30° Freezer

c. -20° Freezer

d. 4° Refrigerator

e. A/C Package Unit

f. A/C Package Unit Parking Booths

g. Liquid Nitrogen System

h. Liquid Nitrogen Generator

i. Reese Monitoring System

j. Constant Temp Room

k. Ice Machine

l. Liquid Nitrogen Freezers

2. Building System

a. Air Compressors

b. CO2 System

c. Vacuum Pump

d. O2 System

3. Air Monitoring

a. Aircuity Sensors

b. Gas Guard

4. Autoclave

a. Autoclave

b. BSL-3 Autoclave

5. Research Safety

a. Bio Safety Cabinet

b. Bio Safety Animal Rack

c. Down Draft Table

d. Fume Hood

6. Animal Care Processing

a. Cage Washer

b. Dumpster Dock Leveler

c. Bedding Machine Waste

d. Glasswasher

e. Tunnel Washer

7. Fire Protection

a. Fire Suppression System

8. Electrical

a. Batteries Flooded -

b. Batteries Gel

c. Battery Monitoring System

d. Uninterrupted Power Supply (UPS)

e. Power Distribution Unit (PDU)

9. Water Processing

a. Water Polisher

b. Water Softener

c. Waste Naturalization System

d. Animal Drinking Water

e. RO/DI water system

10. Other

a. Storage

b. Carpentry

c. Plumbing

d. Cleaning

e. Air Curtains

f. Door Openers

g. Glass Fogging

h. ISO Certifications

i. BSL-3 Certifications

j. AAALAC Certifications

5.2.1. CUSTOMER NOTIFICATION

The Contractor shall notify lab operators and other relevant stakeholders (researchers/doctors) of pending preventative maintenance activities associated with specific lab equipment. The Contractor shall notify all relevant stakeholders in advance of the servicing activity. In addition to the notice to the customer, the Contractor shall notify the COR before work is performed. The Contractor shall schedule the servicing one month prior to the preventative maintenance (PM) due date.

5.2.2. WORK ORDERS

5.2.2.1. PROCESS AND MANAGE WORK ORDER

The Contractor shall maintain a single point of contact continuously during normal working hours on-site. A Contractor Representative shall be physically present on-site during normal hours to receive, process and manage all incoming work requests to include incoming requests from the FDA’s ERIC Call Center.

5.2.2.2. WORK ORDERS

Work order service calls shall be placed through the FDA’s ERIC system, ARHCIBUS system or directly to the Contractor via telephone or email by the COR or a Government Representative. Miscellaneous work orders will be issued to the Contractor by the COR or designated Government Representative.

Although some work orders will be generated by the Employee Resource Information Center (ERIC) and ARCHIBUS, the Contractor is also responsible to identify, on its own, any mechanical or electrical problems to ensure the equipment are operating properly and in acceptable overall condition. The Contractor shall communicate the need for any appropriate work orders to the COR.

The Contractor shall review each work request for completeness, understanding, and clarity. The Contractor shall analyze each work request thoroughly and decompose tasks to identify any deficiencies requiring the initiation of new Work Orders. The Contractor shall schedule this work for completion as directed by the COR.

The Contractor shall inform the CO and COR in writing of any deficiencies requiring the initiation of Work Orders. These deficiencies shall be reviewed and addressed by the COR. The Contractor shall schedule this work for completion as directed by the

CO.

5.2.2.3. SERVICE CALLS

The Contractor shall complete all non-emergency service calls within 48-hours from time of issuance. The Contractor shall remain onsite until the temporary or permanent resolution has been accepted by the COR. Service calls are defined as responses and subsequent maintenance repairs or adjustment of mechanical, or electrical problems reported to the Contractor by FDA Facilities or the ERIC Call Center.

If repairs cannot be made immediately, the Contractor shall notify the COR that further action is required. Upon completion, the Contractor shall return the service ticket to the COR within 24 hours for validation.

5.2.2.4. EMERGENCY WORK ORDERS

Emergency work orders are defined as any type of repair that is urgent in nature as determined by the COR. The Contractor shall respond to emergency work orders initiated during normal work hours within 15 minutes or less. The Contractor shall respond (i.e., be on-site at FDA) to emergency work orders after normal work hours within 1 hour or less and continue diligently working until the emergency has been resolved. The Contractor shall not exceed the cost approved by the CO or COR without approval.

5.2.2.4.1. Emergency Response Procedures

The Contractor shall develop and provide an emergency response procedure in accordance with the Staff Management Guide (SMG) and FDA Safety and Security.

5.2.2.5. 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 for the Contractor’s work. Carpet which is soiled shall be cleaned or replaced as necessary.

The Contractor shall present any pre-existing conditions to the COR with pictures and in writing before work begins.

5.2.3. PREVENTATIVE MAINTENANCE

All local, national codes and regulations shall apply to the particular type(s) of equipment being maintained and repaired including, but not limited to, National Safety Code (NSC), American Society of Heating, Refrigeration and Air Conditioning Engineers (ASRA), Building Officials and Code Administrators (BOCA) and Environmental Protection Agency

(EPA).

The Contractor shall be responsible for following all laws of Section 608 of the Clean Air Act current and future, concerning Hydrofluorocarbons (HFC’s) and Hydrochlorofluorocarbons (HCFC’s) including, but not limited to, recapturing service use, disposal and labeling of HFC’s and HCFC’s. It shall be the responsibility of the Contractor to pay all fines.

Fines: Any fines leveled by State of MD, the Maryland Department of Natural Resources, and the United States Environmental Protection Agency (EPA), etc. that are a result of the Contractor’s negligence will not be reimbursed by FDA.

5.2.3.1. PREVENTATIVE MAINTENANCE (PM) PLAN

The Contractor shall develop and provide a Preventative 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:

1. A description of inspection and maintenance techniques,

2. System shutdown and coordination requirements to include 30 days advance notification prior to shut down, except for emergencies,

3. Preventative maintenance inspections, services and frequencies, with recording methodology, using reliability-centered maintenance (RCM) program,

4. Instructions on how to use the FDA ERIC Call Center and ARCHIBUS system to respond to maintenance related issues.

The Contractor shall adhere to the Preventative Maintenance (PM) Plan to ensure the requirements of the contact contract are provided as specified.

5.2.3.2. PREVENTATIVE MAINTENANCE RECORDS

The Contractor shall manage maintenance records in order to establish maintenance and repair history on each piece of equipment. The maintenance records shall contain all maintenance performed including scheduled and accomplished dates, labor hours, servicing technicians(s) name and initials, materials expenses and other valuable information needed to establish a comprehensive maintenance program.

More specifically, the Contractor shall submit a service ticket prior to departure from FDA to any given service call for preventive maintenance. The service ticket shall include the following, at a minimum:

1. Date and time of arrival and departure from FDA.

2. Description of service performed.

3. Description of equipment ‘as found’ and ‘as left’ in accordance with ISO procedures.

4. Name and quantity of any parts that were repaired/replaced.

5. Diagnostic test results or narrative summary demonstrating that the equipment is operating in accordance with the manufacturer’s specifications.

6. Any comments or recommendations

7. Signature of Contractor’s service personnel (printed/signed).

The Contractor shall maintain any equipment found not to be on the preventative maintenance schedule according to manufactures specifications. The Contractor shall use the most stringent guide for the type of equipment unless otherwise stated.

The Contractor shall migrate to reliability-centered maintenance (RCM) as approved by the COR. The Contractor shall work with the COR to elaborate on all operational procedures associated with RCM in the Operations Management Manual.

The Contractor shall provide copies of the maintenance records as part of the monthly reporting (MPR) to the COR.

5.2.3.3. PREVENTATIVE MAINTENANCE SCHEDULE

A PM schedule shall be provided by the Contractor and subject to Government approval. The first schedule shall be submitted to the Contracting Officer Representative (COR) for approval 120 calendar days after contract award and annual schedules shall be prepared within 90 calendar days thereafter.

The Contractor shall provide a PM schedule formatted with separate sections for the BSL3, AAALAC and ISO 17025 sections or suites.

Because of the nature of the facility and on-going research activities, preventative maintenance and other work performed by the Contractor may require scheduling after normal duty hours. Therefore, no additional overtime will be paid to the Contractor.

5.2.3.4. BSL-3, ISO-17025, & AAALAC MAINTENANCE

The Contractor shall notify the Government in writing five (5) working days before the beginning of the month the service is due of when the service will be provided. The maintenance and certification shall be performed in the first two weeks of the month.

1. BSL-3: The Contractor shall be required to maintain all equipment in accordance with the Standard Operating Procedure outlined in the 6th Edition of the BMBL.

https://www.cdc.gov/labs/BMBL.html.

2. ISO-17025: The Contractor shall be required to maintain all equipment in accordance with ISO 17025 requirements.

3. AAALAC: The Contractor shall be required to maintain all equipment in accordance with the Standard Operating Procedure.

5.2.4. PROACTIVE MAINTENANCE

The Contractor shall conduct building tours to protect the integrity of systems and equipment and to ensure the uninterrupted and continuous work. The Contractor shall ensure the building tours are completed as scheduled and all data recorded in the Contractor logs and in ARCHIBUS. The Contractor shall conduct proactive maintenance to maximize the standard of performance for any FDA laboratory/center. Building tours must be completed twice per day (i.e. one in morning and one in the afternoon).

https://www.cdc.gov/labs/BMBL.html

5.2.5. INVENTORY

The Contractor shall conduct an inventory of all accountable property associated with the Task Orders executed under this IDIQ PWS.

The Contractor shall ensure that all accountable property is controlled in accordance with requirements of FDA Staff Manual Guide FDA 2620.2: Accounting, Inventory Controls, Utilization, and Disposal of Personal Property Assigned to Custodial Areas.

5.2.6. PARTS MANAGEMENT

Parts management involves the staging of parts to execute equipment repairs in the laboratories. Parts management reduces the lead times associated with ordering parts at the time of repair. To satisfy the parts management requirements, the Contractor shall verify the quantities of each replacement part in its inventory per month. The Contractor shall also ensure that all paperwork associated with the parts, including the Order PO, deliverable date, and tracking information, is delivered to both the COR and customer within one (1) week of withdrawal/usage of the parts. The Contractor will be evaluated on ensuring that this information is contained in ARCHIBUS and yield the following:

1. Name of Part

2. Tracking Number

3. Delivery Date

5.3. REPAIRS & EQUIPMENT MANAGEMENT

5.3.1. INCIDENTAL REPAIRS

As part of the services provided under this contract, the Contractor shall perform all incidental repairs necessary to prevent a breakdown or failure of a piece of equipment.

Incidental repairs are defined as unscheduled work required to prevent the breakdown or failure of a piece of equipment or system and return to service after a breakdown or failure where the Contractor’s “cost of labor and parts” does not exceed $2,500.00. This dollar threshold shall be applied to each individual repair job that may be required. An original invoice shall be provided to the COR as requested to confirm the Contractor’s cost.

The Contractor shall immediately perform incidental repairs when they are required to ensure continuity of operations or to return equipment to service as soon as possible. The incidental repairs shall be completed within 24 hours from receipt of notice, or a Mechanical Contract Inspection Report.

The Contractor shall notify the COR by telephone and provide a justification for all incidental repairs that are expected to exceed the twenty-four 24-hour limitation. The COR may waive the twenty-four 24-hour requirement. A written justification may be requested by the COR and a copy forwarded to the CO.

The Contractor shall track all incidental cost and provide a written report monthly to the

COR.

5.3.2. MINOR REPAIRS

As required by the COR, the Contractor shall be responsible for performing all minor repair work up to $25,000.00 in total costs for each repair. The Contractor shall be financially responsible for the first $2,500.00 in costs for each repair. A cost in excess of $2,500.00 costs for the repairs shall be paid by the Government. The responsible cost of the Contractor will increase 3% with each option year.

Prior to proceeding with each minor repair, the Contractor shall submit a cost proposal within twenty-four 24- hours after notification by the COR. Cost proposals submitted by the Contractor shall include all identified cost (i.e., parts, material, labor etc.). The Contractor shall provide additional breakdowns requested by the COR.

The Contractor shall apply the following formula in computing indirect and profit to repairs cost:

Total Labor Cost $ ______________ Total Part Cost $ ______________ (Contractor’s cost includes invoice) $ ______________ Less $2,500.00 Cost $ ______________ Indirect Cost (5%) $ ______________

Each repair shall be invoiced separately.

5.3.3. MAJOR REPAIRS

As directed by the COR, the Contractor shall be responsible for performing all repair work from $25,000.00 to $150,000.00 in total costs for each repair. The Contractor shall be financially responsible for the first $2,500.00 in costs for each repair. A cost in excess of $2,500 costs for the repairs shall be paid by the Government. The responsible cost of the Contractor will increase 3% with each option year.

Prior to proceeding with each major repair, the Contractor shall submit a cost proposal within twenty-four 24- hours after notification by the COR. Cost proposals submitted by the Contractor shall include all identified cost (i.e., parts, material, labor etc.). The Contractor shall provide additional breakdowns requested by the COR.

The Contractor shall apply the following formula in computing indirect and profit to repairs cost:

Total Labor Cost $ ______________ Total Part Cost $ ______________ (Contractor’s cost includes Invoices) $ ______________ Less $2,500.00 Cost $ ______________

Each repair shall be invoiced separately.

5.3.4. BSL-3, ISO-17025, & AAALAC REPAIRS

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 control panel.

5.4. EQUIPMENT CERTIFICATIONS AND WORK CLEARANCES

5.4.1. CERTIFICATIONS

The Contractor shall have all equipment that requires certification completed before the expiration date (e.g. fume hood bio-safety cabinets etc.). The Contractor shall be liable for any loss research or delay of research per day until certification is completed.

The Contractor is responsible for maintaining all FDA certified equipment and shall provide the COR with certification data annually.

5.4.1.1. BIOLOGICAL SAFETY LEVEL 3 (BSL-3)

The BSL-3 is 10 suites totaling 11,711 Sq. Ft, with animal rooms. The Contractor shall be responsible for all equipment from the bubble tight damper through the High Efficiency Particulate Air (HEPA) filters.

The BSL-3 equipment is identified in the “Biosafety in Microbiological and Biomedical Laboratories (BMBL) 6th Edition” manual.

5.4.1.2. INTERNATIONAL ORGANIZATION FOR STANDARD (ISO) 17025

The ISO 17025 equipment is identified in the “International Organization for Standardization (ISO) 17025” manual.

5.4.1.3. ASSOCIATION FOR ASSESSMENT & ACCREDITATION FOR

LABORATORY ANIMAL CARE INTERNATIONAL (AAALAC)

The Vivarium 74,801Sq. Ft., The Contractor will be responsible for all equipment from the bubble tight damper through the High-Efficiency Particulate Air (HEPA) filters.

The AAALAC equipment is identified in the “Association for Assessment and Accreditation for Laboratory Animal Care (AAALAC)” manual.

5.4.1.3.1. WATER TESTING

The Contractor shall be responsible for testing the animal drinking water daily. The Contractor shall provide the test results to the COR and AAALAC team monthly.

5.4.1.4. WARRANTY

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 manufactures’ requirements regarding maintenance services and intervals. The Contractor shall take full advantage of manufacturer warranty obligations.

5.4.2. WORK CLEARANCES

5.4.2.1. MEDICAL SCREENING

The Government shall require medical screening of Contractor personnel at the Contractors expense to comply with the requirements of the Department of Health and Human Services (DHHS) Policy, Health and Human Services (HHS) Occupation Safety, Biological Safety Level 3 (BSL3), Association for Assessment and Accreditation for Laboratory Animal Care International (AAALAC) and Health Manual.

5.4.2.2. UNIFORMS

All Contractor and sub-contract employees shall present a neat appearance and be recognizable via shirting and/or outerwear. All employees shall wear contractor issued distinctive clothing bearing a clearly visible and distinguishable emblem or patch representative of their organization. The clothing shall be approved by the Contracting Officer Representative (COR). The Contractor is expected to have its employees, whether they are Service Contract Act or Davis Bacon Act employees, and as its sub-contractors, in uniform within 30 calendar days of hired date.

5.4.2.3. PROTECTIVE CLOTHING

The Government will furnish protective clothing to Contractor employees required for entry into restricted BSL-3, ISO 17025, and AAALAC areas. Protective clothing includes cloth outer garments such as coveralls, laboratory coats or Tyvek suits, shoe covers, head covering, rubber gloves and Powered Air Purifying Respirator (PAPR).

Other types of respiratory protection, including N95 masks, are the responsibility of the Contractor. The Contractor shall provide respiratory protection including N95 masks and ensure respiratory fit testing. Disposable protective clothing shall be removed and disposed in the waste container as the Contractor exists from aforementioned restricted areas. Soiled cloth clothing shall be returned placed in onsite containers for laundering in onsite containers.

5.4.2.4. TRAINING, CERTIFICATIONS AND LICENSING

The Contractor shall ensure that all employees have received radiation and biological safety training according with DHHS Policy, HHS Occupation Safety and Health Manual. Employees must have all current and valid required professional certifications and engineer’s operation licenses required by FDA and the State of Maryland before starting work.

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

The Contractor shall ensure appropriate staff participation in any training scheduled by the Government during normal working hours at the WOASE.

5.4.2.5. ENVIRONMENT, BUILDING AND SPACE

The Contractor shall protect all adjacent surfaces and the building contents during maintenance 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.

Mechanical rooms or areas around mechanical equipment shall be kept clean and free of dirt and debris. Equipment shall be kept clean and painted as needed per the COR.

The Contractor shall maintain mechanical rooms or areas around mechanical equipment to ensure the rooms and equipment are kept clean and free of dirt and debris.

Equipment shall be kept clean and painted as needed per the COR.

The Contractor shall maintain environmental conditions at all times to ensure the reliable operation of the program equipment in those areas.

6. MANPOWER REQUIREMENTS & LABOR CATEGORY DESCRIPTIONS

The Contractor shall ensure that all Contractor support personnel are adequately trained, possess the credentials specified in the appropriate labor categories, and are otherwise fully qualified to provide the high level of support required by this IDIQ SOW prior to being assigned to task orders awarded:

1. Project Manager

2. Chief Engineer

3. Assistant Chief Engineer

4. Journeymen

5. Electrician

6. Electronic Technician II

7. HVAC Mechanic

8. Instrument Mechanic

9. Laborer

10. Machinery Maintenance Mechanic

11. Maintenance Trades Helper

12. Plumber Maintenance

Each labor category may be utilized in the Task Orders as designated by the FDA.

6.1. KEY PERSONNEL

Pursuant to the Health and Human Service Acquisition Regulation (HHSAR) Clause 352.270-5, “Key Personnel” will be designated in the Task Orders.

The Contractor shall provide the Key Personnel listed below, to demonstrate the technical and management expertise and experience necessary to perform a contract of this magnitude successfully. The CO/COR must approve these positions before and any changes of key personnel during the performance of the contract. The following labor categories shall be considered key personnel for this IDIQ:

1. Project Manager

2. Chief Engineer

3. Assistant Chief Engineer

6.2. LABOR CATEGORY DESCRIPTIONS

Supervisory and technical personnel shall have journeymen level experience in the maintenance of complex industrial facilities and in the operation of utility systems of the type used at WOASE.

Supervisory personnel shall be experienced in the administration, scheduling, and coordination of a work force for the maintenance of facilities such as the WOASE. Employees up to date licenses and certifications as required by the law. Proof of these documents must be presented to the COR upon request.

Labor Category Labor Category Descriptions Project Manager (Key)

Project Manager shall be responsible for the following:

• Successful execution and completion of one or more projects.

• Leads a team of resources to monitor, track, and own the progress of tasks within the project plan.

• Interfaces with the customer concerning technical and operational issues, contractual clarifications and proper supervision and accounting of all project personnel.

• May lead a team of consultants within one or more projects.

• May perform one or more of the following activities: assembling project team, assigning individual responsibilities, identifying appropriate resources needed, developing schedule to ensure timely completion of project, meeting deadlines of project, project scope management, project time management, project cost management, project quality management, project human resource management, project communications management, project risk management, and project procurement management.

• The Project manager shall be the property officer accountable for all accountable property provided by the government. The Project Manager shall adhere to the requirements of the FDA Staff Manual Guide 2620 (Accounting and Inventory Control for Property). The Project Manager may also serve as the Safety Manager.

• The Project Manager can expect to be onsite 2 to 3 days a week.

And be available to be onsite with 1hours for emergencies.

Minimum experience:

• Ten-year minimum experience supporting Federal Government, and managing research laboratories, systems for a Biosafety Level 3 Laboratory, and AAALAC International and ISO 17025 accredited facilities that houses animals for research programs.

• Program Management Certifications:

o Facility Management Professional (FMP), and o Project Management Professional (PMP) certification, and/or o Certified Associate in Project Management

• Bachelor’s Degree in a relevant field; or:

o 10 years relevant experience commensurate with the

Project Manager position; or o Relevant experience in managing large contracts over $50 million dollars

Chief Engineer (Key)

The Chief Engineer selected shall be onsite during normal working hours and be available at all times. The name of the Chief Engineer, the Assistant Chief Engineer and the Journeymen, who shall act on behalf of the Contractor when the Chief Engineer is absent, shall be submitted to the Contracting Officer in writing.

The Chief Engineer acts in leadership role and provides technical expertise to the project management team/project manager. Facilitates communication among technical disciplines and directs activities and policies associated with engineering efforts. Supports complex and/or technically challenging tasks including the leadership in generating the Task Plan and technical approaches. Conducts technology assessments and makes recommendations for technology insertions. Makes trade study assessments, and recommendations, supports major Design Reviews, and reviews deliverables. Provides technical consultation advice to Task Managers regarding design issues, development and test approaches, and test result assessments. Leads teams established by the Program Manager to conduct investigations of programmatic or task-level problems and to make recommendations for recovery plans. Familiar with risk evaluation, tracking, and risk mitigation implementation techniques consistent with continuous risk management processes.

The Chief Engineer serves as the Prime contractor spokesperson on technical capabilities and future directions. The Chief Engineer may also serve as the Safety Manager.

Minimum experience:

• Bachelor’s Degree in a relevant field or equivalent work experience.

• A Maryland Master HVAC License

• Must have QA/QC Certification

• Must have ISO 9000/ISO 17025 Lead Auditor Certification

• Ten-year minimum experience supporting and managing research laboratories, systems for a Biosafety Level 3 Laboratory, and AAALAC International and ISO 17025 accredited facilities that houses animals for research programs.

Assistant Chief Engineer (Key)

The Assistant Chief Engineer acts in leadership role and provides technical expertise to the project management team. Depending upon the complexity of the project may act as Chief Engineer or Deputy Chief Engineer.

Facilitates communication among technical disciplines and directs activities and policies associated with engineering efforts. Supports complex and/or technically challenging tasks including the leadership in generating the Task Plan and technical approaches. Conducts technology assessments and makes recommendations for technology insertions. Makes trade study assessments, and recommendations, supports major Design Reviews, and reviews deliverables. Leads teams established by the Program Manager to conduct investigations of programmatic or task-level problems and to make recommendations for recovery plans.

Minimum Experience:

• Bachelor’s Degree in a relevant field or equivalent work experience.

• A Maryland Journeymen HVAC License

• Ten-year minimum experience supporting and managing research laboratories, systems for a Biosafety Level 3 Laboratory, and AAALAC International and ISO 17025 accredited facilities that houses animals for research programs.

Journeyman (Key)

The Journeyman works independently or with a very small team of one to two junior level employees in their administrative, technical, or functional area of expertise. Capable of independently performing all subfunctions of the functional area of expertise.

In addition, the Journeymen may determine type and costs of materials required for the projects, ensures specifications and drawings are accurate by reviewing projects and plans, determining layouts and testing electrical patterns. Also, Perform upgrades or preventive maintenance to electrical control systems. The Journeymen supervise apprentices and manage other electricians while working on various projects without superior's supervision.

Minimum Experience:

• High School diploma or equivalent

• Ten-year minimum experience supporting and managing research laboratories, systems for a Biosafety Level 3 Laboratory, and AAALAC International and ISO 17025 accredited facilities that houses animals for research programs.

• Certificate of Completion of Apprenticeship Program or Maryland Journeyman license

Electrician An Electrician performs a variety of electrical trade functions such as the installation, maintenance, or repair of equipment for the generation, distribution, or utilization of electric energy. Work involves most of the following: installing or repairing any of a variety of electrical equipment such as generators, transformers, switchboards, controllers, circuit breakers, motors, and heating units. Conduit systems, or other transmission equipment; working from blueprints, drawings, layouts, or other specifications, locating and diagnosing trouble in the electrical system or equipment, working standard computations relating to load requirements of wiring or electrical equipment, and using a variety of electrician's hand tools and measuring and testing instruments. In general, the work of the maintenance electrician requires rounded training and experience usually acquired through a formal apprenticeship or equivalent training and experience.

Minimum Experience:

• Ten (10) year experience as an electrician

• High school diploma or equivalent

• Professional / Trade School Certification

Electronics Technician II

Applies basic and some advanced technical knowledge to solve routine problems by interpreting manufacturers’ manuals or similar documents.

Work requires familiarity with the interrelationships of circuits and judgment in planning work sequence, in selecting tools, testing instruments, and is reviewed for compliance with accepted practices. Inspects tests and repairs complex electronic circuitry and components in accordance with regulations and specifications. Records test data and calibrates equipment.

Analyzes electronic equipment and oversees tests to establish operating data. Develops and fabricates specialized equipment. Provides training and assistance to lower-level technicians.

Minimum Experience:

• Associates Degree or Technical Certification from an accredited training institution and five (5) years’ experience with 1 year of specialized experience. Specialized experience as applied in this context means direct experience working on the type of equipment listed in the Master Equipment List.

• Minimum of five (5) years of practical experience in the maintenance, troubleshooting, or repair of digital computers, computer peripheral/ interface equipment, VME based systems, digital, switches, radio frequency transmitters, receivers, antennas, and modems. Must have at least an Associate Degree in Electronics Technology.

HVAC Mechanic

HVAC mechanics install, operate, maintain, and repair the heating, ventilation, air conditioning, and refrigeration equipment for any structure. HVAC mechanics perform a variety of duties in a large number of capacities, ranging from setting up HVAC systems to installing water-based heating systems. Their most basic duties are centered around the installation and maintenance of complex HVAC systems that are essential to a building’s operation.

The HVAC Mechanic installs, services and repairs environmental-control systems in office buildings and other FDA establishments, utilizing knowledge of refrigeration theory, pipefitting and structural layout. Mounts compressor, and condenser units on platform or floor, using hand tools, following blueprints or engineering specifications. Fabricates, assembles and installs ductwork and chassis parts, using portable metalworking tools and welding equipment. Installs evaporator unit in chassis or in air-duct system, using hand tools. Cuts and bends tubing to correct length and shape, using cutting and bending equipment and tools. Cuts and threads pipe, using machine-threading or hand-threading equipment. Joins tubing or pipes to various refrigerating units by means of sleeves, couplings or unions, and solders joints, using torch, forming complete circuit for refrigerant. Installs expansion and discharge valves in circuit. Connects motors, compressors, temperature controls, humidity controls and circulating ventilation fans to control panels and connects control panels to power source. Installs air and water filters in completed installation. Injects small amount of refrigerant into compressor to test systems and adds Freon gas to build up prescribed operating pressure. Observes pressure and vacuum gauges and adjusts controls to insure proper operation. Tests joints and connections for gas leaks, using gauges or soap-and-water solution. Wraps pipe in insulation batting and secure them in place with cement or wire bands.