Attachment IV - Technical Scenario Statement of Work.pdf

Attachment IV- Technical Scenario Statement of Work

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)

Technical Scenario – Repairs & Equipment Management

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

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

4.3.1. NOTICE TO THE GOVERNMENT OF DELAYS

5. DESCRIPTION OF WORK

5.1.1. TASKS AND DELIVERY

5.1.2. INCIDENTAL REPAIRS

5.1.3. MINOR REPAIRS

5.1.4. MAJOR REPAIRS

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

6. TASK ORDER DELIVERABLES

6.1. SCHEDULE OF 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 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

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

3. SCOPE

The Contractor shall provide FDA with all parts and repair and replacement 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.

Once repairs are completed, a report describing the condition and operation shall be provided by the contractor to the Contracting Officer’s Representative (COR).

3.1. APPLICABILITY

This TO effort is within the scope of Section 5.3 “Repairs and Equipment Management” 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

The period of performance shall be two-months from the date of award.

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).

4.3. HOUR OF OPERATIONS

Work at a Government site shall not take place on Federal holidays or weekends unless directed by the CO. There are 10 Federal holidays set by law (USC Title 5 Section 6103) that FDA follows:

Under current definitions, four are set by date:

New Year's Day January 1 Juneteenth National June 19 Independence Day July 4 Veterans Day November 11 Christmas Day December 25

If any of the above falls on a Saturday, then Friday shall be observed as a holiday. Similarly, if one falls on a Sunday, then Monday shall be observed as a holiday.

The other six (6) are set by a day of the week and month:

Martin Luther King's Birthday Third Monday in January Presidents Birthday Third Monday in February Memorial Day Last Monday in May Labor Day First Monday in September Columbus Day Second Monday in October Thanksgiving Fourth Thursday in November

Any other day designated by Federal statute Any other day designated by Executive Order

Any other day designated by the President

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 will not be able to perform on-site under this contract with FDA on holidays set forth above. The Contractor will 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 will 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.

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.

4.3.1. 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. DESCRIPTION OF WORK

The Contractor shall perform all repairs necessary to prevent a breakdown or failure of a piece of equipment. The Contractor shall perform repairs 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. Water Processing

a) Water Polisher

b) Water Softener

c) Waste Naturalization System

d) Animal Drinking Water

e) RO/DI water system

5.1.1. TASKS AND DELIVERY

• Bldg. XXX, Room XXX – Install two (2) Incubator REES Probes o The Contractor shall provide the FDA with all parts and labor for incubator probes, returning the system to proper operation. Once repairs are completed, a report describing the condition and operation shall be provided by the contractor to the Contracting Officer’s Representative (COR). If this unit is listed as an ISO, AAALAC, or BSL-3 unit, the Contractor shall include a full report in accordance with the requirements in the SOW. This work shall be performed by the LES.

o System Specification(s): Rees Scientific Incubator Probes, Model #TBDSerial 1 #TBD and Serial 2 #TBD.

o Task and Delivery: The contractor’s responsibility includes, but is not limited to, installing two (2) incubator probes and recertifying with the same type of incubator probes that were originally in the unit.

• Bldg. XXX, Room XXX – Replace Compressor and Evaporator o The Contractor shall provide the FDA with all parts and labor for replacing the compressor and the evaporator, returning the system to proper operation. Once repairs are completed, a report describing the condition and operation shall be provided by the contractor to the Contracting Officer’s Representative (COR). If this unit is listed as an ISO, AAALAC, or BSL-3 unit, the Contractor shall include a full report in accordance with the requirements in the SOW. This work shall be performed by the LES.

o System Specification(s): Panasonic Ultra Low, Compressor Model #TBD Serial

#TBD (2) Evaporator Model #TBD Serial #TBD.

o Task and Delivery: The contractor’s responsibility includes, but is not limited to, replacing the compressor and evaporator, and returning the system to proper operation.

• Bldg. XXX, Room XXX – Replace Two (2) Compressors o The Contractor shall provide the FDA with all parts and labor for replacing both compressors, returning the system to proper operation. Once repairs are completed, a report describing the condition and operation shall be provided by the contractor to the Contracting Officer’s Representative (COR). If this unit is listed as an ISO, AAALAC, or BSL-3 unit, the Contractor shall include a full report in accordance with the requirements in the SOW. This work shall be performed by the LES.

o System Specification: Thermal Fisher First and Second Stage Compressors, (1) Model #TBDSerial #TBD and (2) Model #TBD Serial #TBD.

o Task and Delivery: The contractor’s responsibility includes, but is not limited to, replacing two (2) compressors, returning the system to proper operation.

• Bldg. XXX, Room XXX – Replace Two (2) Chemical Feed Pumps o The Contractor shall provide the FDA with all parts and labor for two (2) chemical feed pumps, returning the systems to proper operation. Once repairs are completed, a report describing the condition and operation shall be provided by the contractor to the Contracting Officer’s Representative (COR). If this unit is listed as an ISO, AAALAC, or BSL-3 unit, the Contractor shall include a full report in accordance with the requirements in the SOW. This work shall be performed by the LES.

o System Specification: Pulsatron Chemical Feed Pumps, (1) Model #TBD Serial #TBD and (2) Model #TBDSerial #TBD Task and Delivery: The contractor’s responsibility includes, but is not limited to, replacing two (2) chemical feed pumps, returning the systems to proper operation.

5.1.2. INCIDENTAL REPAIRS

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 costs and provide a written report monthly progress report to the COR. The written report shall include the following:

Table 1 - Sample Equipment Repair Cost Table

Equipment Description Model No.

Serial No. FDA Asset No. Cost On-Demand/ Work Order #

Thermo Scientific Compressor

906 813687-2653 435ASE000788 TBD TBD

TBD

Table 2 - Sample Itemized Invoice for Incidental Repairs

Repair Description

Itemized Labor

Category

Labor Rate

Level of Effort (Hours)

Subtotal (Labor)

Itemized Part

Quantity Total

Ice Machine Compressor Replacement

Journeyman $ 2 $ Compressor 1 $ Chief Engineer

$ 1 $ Ancillary Hardware

Deliverables:

A. Monthly Progress Report, including those from ARCHIBUS

5.1.3. MINOR REPAIRS

As directed 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.

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 costs, including all required parts, material, and labor. The Contractor shall provide additional breakdowns requested by the COR.

The Contractor shall itemize all cost elements to include the following:

Table 2 - Sample Equipment Repair Cost Table

No.

Serial No. FDA Asset No. Cost On-Demand/ Work Order #

Thermo Scientific Compressor

Table 2 - Sample Itemized Invoice for Repairs Exceeding $2500

Description

Itemized Labor

Category

Labor Rate

Level of Effort

(Hours)

Subtotal (Labor)

Itemized Part

Quantity Part Cost

Total

Ice Machine Compressor Replacement

Journeyman $ $ Compressor 1 $ $ Chief Engineer

$ $ Ancillary Hardware

1 $

Less $2,500.00 Cost

TOTAL: $

Each repair shall be itemized.

The Contractor shall submit this information within the Monthly Progress Report delivered as part of this TO.

A. Monthly Progress Reports

5.1.4. MAJOR REPAIRS

As directed by the COR, the Contractor shall be responsible for performing all major 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 $2,500.00 costs for the repairs shall be paid by the Government.

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 itemize all cost elements to include the following:

Table 3 - Sample Equipment Repair Cost Table

No.

Serial No. FDA Asset No. Cost On-Demand/ Work Order #

Thermo Scientific Compressor

Table 2 - Sample Itemized Invoice for Repairs Exceeding $2500

Description

Itemized Labor

Category

Labor Rate

Level of Effort

(Hours)

Subtotal (Labor)

Itemized Part

Quantity Part Cost

Total

Ice Machine Compressor Replacement

Journeyman $ 20 $ Compressor 1 $ $ Chief Engineer

$ 10 $ Ancillary Hardware

1 $

Less $2,500.00 Cost

TOTAL: $

Each repair shall be itemized.

The Contractor shall submit this information as updates to the Monthly Progress Report delivered as part of this TO.

A. Monthly Progress Reports

5.1.5. 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 COR and CO in writing of all defects that the Contractor considers it is not responsible for under the terms of the contract.

The Contractor shall submit this information as updates to the Monthly Report delivered as part of this TO.

Deliverables:

A. Monthly Progress Reports

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 Statement of Work (SOW) 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 SOW and satisfy the performance standards developed under the SOW. 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

Task Deliverable ID Deliverable Description

5.1.2 Incidental Repairs

A

Monthly Progress Reports Microsoft Word or Microsoft Excel Due 30 days after receipt of order (ARO) and updated monthly thereafter (last week of each month) Electronic submission via e-mail to: COR and CO.

Inspection: COR Acceptance: COR

5.1.3 Minor Repairs

A Monthly Progress Reports Microsoft Word or Microsoft Excel Due 30 days after receipt of order (ARO) and updated monthly thereafter (last week of each month) Electronic submission via e-mail to: COR and CO.

Inspection: COR Acceptance: COR

5.1.4 Major Repairs

Due 30 days after receipt of order (ARO) and updated monthly thereafter (last week of each month) Electronic submission via e-mail to: COR and CO.

Inspection: COR Acceptance: COR

5.1.5

BSL-3, ISO-

17025, &

AAALAC

REPAIRS

Due 30 days after receipt of order (ARO) and updated monthly thereafter (last week of each month) Electronic submission via e-mail to: COR and CO.

Inspection: COR Acceptance: COR