Statement of Work (SOW).docx

Statement of Work

Preventative Maintenance Service for Sartorius Arium Laboratory Water Purification Units

1. Background As part of a 2023 laboratory renovation at Seattle Human and Animal Food Laboratory (SEAHAF), the U.S. Food and Drug Administration (FDA) purchased and installed seven Sartorius Arium laboratory water purification units. These units purify and polish city tap water and/or processed water to American Society for Testing and Materials (ASTM) grade water for laboratory use. SEAHAF requires the use of high-grade laboratory water for regulatory sample testing and research work to accomplish the agency’s mission of protecting the public health. A preventative maintenance (PM) service contract is required to maintain these units to consistently produce laboratory grade water.

2. Objective The objective of this requirement is to procure a preventative maintenance service contract to service and maintain seven Sartorius Arium laboratory water purification units.

3. Scope Sartorius Arium water purification units PM service shall include providing a Sartorius original equipment manufacturer (OEM) qualified maintenance technician that is familiar with Sartorius Arium Comfort I, II, and Pro water purification units. The technician shall provide quarterly preventative maintenance (PM) to clean and sanitize each unit, replace components, replace filters, and ensure operational parameters in accordance with the OEM specifications of each water purification unit and the detailed guidance listed below.

Arium Comfort I BT Combined H20 w/UV lamp and TOC Monitor w/ Smart Station

H2O-I-1-TOC-T

H2O-ARST-UP-T

Arium Comfort I BT Combined H20 w/UV lamp and TOC Monitor w/ Smart Station

H2O-I-1-TOC-T

H2O-ARST-UP-T

Arium Comfort I TOC w/1 RO Module w/ Smart Station

H2O-I-1-TOC-B

H2O-ARST-UP-T

Arium Comfort I TOC w/1 RO Module w/ Smart Station

H2O-I-1-TOC-B

H2O-ARST-UP-T

Arium Comfort II EDI w/2 RO Modules w/ Smart Station

H2O-II-2-TOC-B

H2O-ARST-UP-T

H2O-ARST-UP-T

H2O-ARST-UP-T

3.1 The contractor shall inform the government ahead of time should any recommended work interrupt lab operations.

Contracting Officer Representative (COR) or government representative prior to exiting the building.

3.8 The contractor shall provide a field service report to the COR or government representative within 5 days of the completion of the PM service outlining the work performed, the identification of the units serviced, any applicable test and/or measurements assessed to verify that the performance of the units meet or exceed OEM specifications.

4. Additional Requirements

4.1 The contractor shall provide a recommended quarterly maintenance schedule to the COR for review and approval within 10 days of contract award.

4.2 The contractor shall procure all necessary parts & supplies required for routine PM per manufactured recommendations. All consumables, components, and filters used to service the listed units shall not be expired or past the USE BY date.

4.3 The contractor shall perform all work during FDA’s regular business hours on regular business days. Current regular business hours include Monday through Friday, except for established government holidays, 7:00 A.M. to 4:00 P.M. local standard time. These business hours may be subject to change. The contractor shall also schedule PM service at least seven (7) business days prior to PM due date with the COR.

5. Deliveries and Performance

Satisfactory performance of this contract shall be established upon successful delivery of the services and supplies described in this Statement of Work (SOW) and upon acceptance by the COR.

Services shall be performed upon the commencement of the contract award period of performance in accordance with the following schedule:

PM Quarterly Service Visit

Arium Pro PM Service Tasks Arium Pro Consumables Part Number Arium Comfort I & II PM Service Tasks Arium Comfort I & II Consumables Part Number

2. Replace pre-treatment cartridge

3. Replace sterile final filter

H20-CCS

H2O-CPFCO-1

5441307H4-CE

2. Replace sterile final filter

611CDS1

5441307H4-CE

1. System cleaning*

2. Replace water storage bag

3. Replace pre-treatment cartridge

4. Replace softener cartridge (Comfort II)

5. Replace sterile final filter

H20-CCS

H2O-CBS-20 (Comfort I) H2O-CBS-50 (Comfort II)

H2O-CPFCO-1

H2O-CSO-1 (Comfort II)

5441307H4-CE

2. Replace pre-treatment cartridge

3. Replace sterile final filter

H20-CCS

H2O-CPFCO-1

5441307H4-CE

2. Change cartridge analytical kit

3. Replace ultrafilter cartridge

4. Replace ultra-violet lamp

5. Recalibrate total organic carbon sensor

6. Replace sterile final filter

611CDS1

H2O-A-PACK

611CDU5

611CEL1

84MAB69

5441307H4-CE

1. System cleaning*

2. Replace water storage bag

3. Replace pre-treatment cartridge

4. Replace reverse-osmosis module

5. Replace softener cartridge (Comfort II)

6. Replace ultra-violet lamp

7. Recalibrate total organic carbon sensor (TOC)

8. Replace comfort kit

9. Replace sterile final filter

H20-CCS

H2O-CBS-20 (Comfort I) H2O-CBS-50 (Comfort II)

H2O-CPFCO-1

613CPM4 (Comfort I) H2O-CRO-H-2 (Comfort II) H2O-CSO-1 (Comfort II)

611CEL1

84MAB69

H2O-C-PACK 5441307H4-CE

*See Attachment Below

6. Deliverables

7. Government Holidays

a) The government hereby provides notification that government personnel observe the listed days as holidays:

(6) Independence Day

b) 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

c) When any such day falls on a Saturday, the following Monday is observed. The 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 award.

d) It is understood and agreed between the government and the contractor that observance of such days by government personnel shall not otherwise be a reason for an additional period of performance, or entitlement of compensation except as set forth within the award.

e) Nothing in this clause abrogates the rights and responsibilities of the parties relating to stop work provisions as cited in other sections of this contract.

9. Existing Conditions All government property or systems displaced, altered, or damaged during the performance of this contract other than stated in this SOW shall be restored to its original condition at no cost to the government. These repairs, if needed, shall be executed immediately when the contractor is notified by the CO that such repairs are required due to actions by the contractor or his/her subcontractors.

8. Place of Performance

U.S. Food & Drug Administration Seattle Human and Animal Food Laboratory (SEAHAF) 22201 23rd Drive Southeast Bothell, WA 98021

9. Period of Performance

The period of performance shall include one (1) base year and four (4) option periods of twelve (12) months each. The vendor shall perform the PM on-site at the location of the water purification units. The work shall not be performed remotely.

*Attachments:

Appendix A: Field Service Report Template