Attachment III - Task Order 2 Statement of Work - Operations and Maintenance (1).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)

Task Order 2 – Operations and Maintenance

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

Date: 3 April 2020 Version Number: 0.1

Contents

1. BACKGROUND

2. APPLICABLE DOCUMENTS

3. SCOPE

3.1. APPLICABILITY

3.2. ORDER TYPE

4. PERFORMANCE DETAILS

4.1. PERIOD OF PERFORMANCE

4.2. PLACE OF PERFORMANCE

4.3. HOUR OF OPERATIONS ............................................................ Error! Bookmark not defined.

4.3.1. NOTICE TO THE GOVERNMENT OF DELAYS .................. Error! Bookmark not defined.

5. OPERATIONS AND MAINTENANCE (O & M)

5.1. CUSTOMER NOTIFICATION

5.2. WORK ORDERS

5.2.1. PROCESS AND MANAGE WORK ORDER

5.2.2. WORK ORDERS

5.2.3. SERVICE CALLS

5.2.4. EMERGENCY WORK ORDERS

5.2.4.1. Emergency Response Procedures

5.2.5. CLEANING

5.3. PREVENTATIVE MAINTENANCE

5.3.1. PREVENTATIVE MAINTENANCE (PM) PLAN

5.3.2. PREVENTATIVE MAINTENANCE RECORDS

5.3.3. PREVENTATIVE MAINTENANCE SCHEDULE

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

5.4. PROACTIVE MAINTENANCE

5.5. INVENTORY

5.6. PARTS MANAGEMENT

6. TASK ORDER DELIVERABLES

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. The Food and Drug Administration’s (FDA) White Oak Above Standard Equipment Contract provides specialty equipment maintenance and repair services to the FDA White Oak Campus and supports FDA’s mission to protect public health by ensuring lab specialty equipment located at the White Oak Campus, are maintained and repaired according to local, state, federal and industry standards and regulations including BSL3, ISO and AAALAC standards. This Statement of Work (SOW) seeks to establish a new IDIQ Task Order (TO) to provide equipment service/support to over 3,400 pieces of specialty equipment to include additional locations contained in the Site List.

2. APPLICABLE DOCUMENTS

1. The Contractor shall comply with all applicable documents listed in the Basic IDIQ PWS.

2. Master Equipment List

3. FDA-ASE Preventive Maintenance (PM) Procedures

4. PM Schedule

5. Daily Route Sheet

3. SCOPE

The Contractor shall provide FDA with operations and maintenance services for the following:

1. Refrigeration

2. Building System

3. Air Monitoring

4. Autoclave

5. Research Safety

6. Animal Care Processing

7. Fire Protection

8. Electrical

9. Water Processing

Specific items for each category are listed in Section 5.

3.1. APPLICABILITY

This (TO) effort SOWis within the scope of Section 5.2 “Operations and Maintenance” of the Preventative Maintenance of Above Standard Equipment at the FDA White Oak Campus IDIQ

SOW.

3.2. ORDER TYPE

The effort shall be proposed on Fixed Price (FP) basis.

4. PERFORMANCE DETAILS

4.1. PERIOD OF PERFORMANCE

Base Period: 09/30/2022 – 03/28/2023 Option Period 1: 03/29/2023 – 03/28/2024 Option Period 2: 03/29/2024 – 03/28/2025 Option Period 3: 03/29/2025 – 03/28/2026 Option Period 4: 03/29/2026 – 03/28/2027

4.2. PLACE OF PERFORMANCE

The place of performance for this Task Order shall be the White Oak Campus (WO), located at:

10903 New Hampshire Ave, Silver Spring, Maryland 20993

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

(OCONUS).

5. OPERATIONS AND MAINTENANCE (O & M)

The Contractor shall conduct operations and maintenance on the following equipment:

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. CO2 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

5.1. 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.

Customer notifications shall occur as follows:

1. Two (2) month notice via e-mail to the customer and the COR

2. One (1) month reminder notice via e-mail to the customer and the COR

3. One (1) week prior post PM notice on the door of the targeted lab. The Contractor shall notify the COR of the posting of the PM notice via e-mail.

Deliverable:

A. Email notifications

5.2. WORK ORDERS

5.2.1. 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. 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.

A. Work Order requests via e-mail

5.2.3. SERVICE CALLS

Non-Emergency 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.

The Contractor shall submit a service ticket prior to departure from FDA to any given service call for repair services. 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; and

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

A. Service Ticket (via e-mail or ARCHIBUS notification)

5.2.4. 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.

5.2.4.1. 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.

Deliverable:

A. Service Ticket (via e-mail or ARCHIBUS notification) B. Emergency Response Procedures

5.2.5. CLEANING

The Contractor shall be responsible for cleaning all areas immediately after the work has been performed and return it to its original condition. Cleaning shall include broom cleaning, removal of all smudges, grease, stains, dirt, paint drips, and refuse resulting for the Contractor’s work. The

Contractor shall be responsible for cleaning and/or replacing carpet which is damaged or soiled by the Contractor. The Contractor shall present any pre-existing conditions to the COR with pictures and in writing before work begins.

Deliverable:

A. Carpet B. Pictures of pre-existing conditions and/or damages

5.3. 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 (HFCs) and Hydrochlorofluorocarbons (HCFCs) including, but not limited to, recapturing service use, disposal and labeling of HFCs and HCFCs. 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.

5.3.1. PREVENTATIVE MAINTENANCE (PM) PLAN

The Contractor shall develop and provide a PM 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 PM Plan to ensure the requirements of the contract are provided as specified.

Deliverables:

A. Preventative Maintenance (PM) Plan

5.3.2. 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; and

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.

A. Monthly Progress Report Maintenance Records in MPRs

5.3.3. PREVENTATIVE MAINTENANCE SCHEDULE

A PM schedule will 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.

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.

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

A. Preventative Maintenance Schedule

5.3.4. 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.

A. Maintenance Notification via e-mail and/or ARCHIBUS

5.4. 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).

Deliverables:

A. Contractor Logs and ARCHIBUS updates

5.5. INVENTORY

The Contractor shall conduct an inventory of all accountable property associated with this Task Order.

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.

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

A. Inventory of Equipment

5.6. 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 the COR 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:

a. Name of Part

b. Tracking Number

c. Delivery Date

The Contractor shall ensure that all information is contained in ARCHIBUS.

A. Inventory of Parts B. ARCHIBUS updates

6. TASK ORDER DELIVERABLES

The COR will review contractor deliverables in accordance with specifications and standards stated in the criteria established and any directives issued during the term of this contract. The COR has the authority to accept or reject deliverables.

The acceptance of deliverables and satisfactory work performance required herein shall be based upon the timeliness, accuracy, craftsmanship, and suitability of the deliverable. The specific deliverables and schedule for delivery shall be as agreed upon and documented.

Deliverables shall be submitted to the COR.

A final inspection and acceptance of all work performed, reports and other deliverables will be performed by the COR to ensure the services/products provided meet the requirements of the Performance Work Statement (PWS) at the time of delivery, and the Contractor shall make changes as requested during the inspection and acceptance process.

Inspection and acceptance will occur at the place of performance and take place within ten (10) days of task being completed. The FDA will reject non-conforming products and services. The FDA will provide written notification of acceptance or rejection within ten (10) business days.

Inspection will include review of the deliverables to ensure adequacy. The FDA will accept goods, reports and services only if they conform to all terms and conditions of the PWS and satisfy the performance standards developed under the PWS. The Contractor shall incorporate all FDA feedback and submit revised deliverables within five (5) business days of receipt. If the Contractor cannot correct the deficiencies within the five (5) day cycle, the Contractor shall immediately notify the COR of the reason for the delay and provide a proposed corrective action plan within five (5) business days.

6.1. SCHEDULE OF DELIVERABLES

Deliverable Title Deliverable ID Deliverable Description

5.1 Customer Notification

A

Email Notifications to the COR and the customer Due date:

At least two (2) month notice via e-mail At least one (1) month reminder notice via e-mail At least one (1) week prior post PM notice on the door of the targeted lab.

5.2.2 Work Orders

A Electronic submission of Work Order Requests

Due Date: Ad Hoc and as agreed to by the COR

5.2.3 Service Calls

Service Ticket (via e-mail or ARCHIBUS notification)

Due Date: Ad Hoc and as agreed to by the COR

5.2.4 Emergency Work

Orders

Service Ticket (via e-mail or ARCHIBUS notification)

B Emergency Response Procedures

Due Date: Ad Hoc and as agreed to by the COR

5.2.5 Cleaning

A Carpet Due Date: Ad Hoc and as agreed to by the COR

B Pictures of pre-existing conditions and/or damages

Due Date: Ad Hoc and as agreed to by the COR

5.3.1 PM Plan

A Preventative Maintenance (PM) Plan

Due Date: 90-days after award; Ad Hoc and as agreed to by the COR

5.3.2 PM Records

A Maintenance Records in MPRs

Due Date: Ad Hoc and as agreed to by the COR

5.3.3 PM Schedule

A Preventative Maintenance (PM) Schedule

Due Date: Ad Hoc and as agreed to by the COR

5.3.4

BSL-3, ISO-17025, &

AAALAC Maintenance

A Maintenance Notification via e-mail and/or

ARCHIBUS

5.4 Proactive Maintenance

A Contractor Logs and ARCHIBUS updates

5.5 Inventory

A Inventory of Equipment Due Date: Quarterly and as required by the COR

5.6 Parts Management

A Inventory of Parts Due Date: Ad Hoc and as agreed to by the COR

B ARCHIBUS Updates