D1 SOW Autoclave 041521.pdf

STATEMENT OF WORK (SOW)

General Information

Title of Project:

Autoclave, Steam Generator, Water Softener and Glassware washer service agreement.

Statement of Need and Purpose:

The National Center for Advancing Translational Sciences (NCATS) Division of Preclinical

Innovation (DPI), previously purchased eight autoclave instruments (Serial Numbers

URA013705, 44079, AG24625, URA013704, 44080, AG24626, 5170536 and 00/074399946).

The DPI will continue to use these instruments for sterilizing tips, tubes and glass bottles used in microbiology as well as sterilizing hazardous waste generated by biology experiments. To maintain these instruments in fully functioning, peak condition, scheduled preventive maintenance and service are required.

Background Information and Objective:

The National Institutes of Health (NIH) is the nation’s leading medical research agency and the primary Federal agency whose mission is to seek fundamental knowledge about the nature and behavior of living systems and the application of that knowledge to enhance health, lengthen life, and reduce illness and disability, conducting, supporting and making medical discoveries that improve people’s health and save lives.

The National Center for Advancing Translational Sciences (NCATS) is a part of the National

Institutes of Health (NIH), which mission it is to catalyze the generation of innovative methods and technologies that will enhance the development, testing and implementation of diagnostics and therapeutics across a wide range of human diseases and conditions.

The Division of Preclinical Innovation (DPI) plans, conducts and uses both internal and contract resources to advance collaborative research projects across the preclinical phases of the translational science spectrum. Specifically, this division:

• Plans, conducts and collaborates on research to develop new methods and technologies to enhance preclinical processes.

• Plans, conducts and collaborates on research to evaluate existing and developing approaches, technologies, and processes in the preclinical spectrum.

• Supports training programs relevant to preclinical phases of translational science.

• Allocates DPI resources to preclinical extramural and intramural investigators.

• Collaborates with other NIH Institutes and Centers and the scientists they support.

• Consults with stakeholders, including patients, industry and regulators.

The DPI requires a service agreement to maintain the autoclave instruments (Serial Numbers

URA013705, 44079, AG24625, URA013704, 44080, AG24626, 5170536 and 00/074399946) in fully functioning order via preventative maintenance and up to six (6) emergency calls and service for one 12-month base year and three 12-month successive option years.

Period of Performance:

The period of performance shall be twelve (12) months for Base Period, with four (4) Option

Period of twelve (12) months :

• Base year - 05/18/2021 to 05/17/2022

• Option year 1 - 05/18/2022 to 05/17/2023

• Option year 2 - 05/18/2023 to 05/17/2024

• Option year 3 - 05/18/2024 to 05/17/2025

• Option year 4 - 05/18/2025 to 05/17/2026.

Place of Performance:

The place of performance shall be 9800 Medical Center Dr, Rockville MD 20850

Scope of Work

General Requirements:

Independently and not as an agent of the Government, the Contractor shall furnish all the necessary services, qualified personnel, material, equipment, and facilities, not otherwise provided by the Government as needed to perform the Statement of Work below:

SERVICE AGREEMENT COVERAGE:

1. Three (3) preventative maintenance (PM) visits per year

2. Up to six (6) emergency call per unit per year

a. Emergency service guaranteed to begin within 12 hours of customer’s call.

EQUIPMENT COVERED:

1. Instrument: Getinge model 533LS sterilizer Serial Number: URA013705 Location: Room 215-W

2. Instrument: Chromalox model GTS30 steam generator Serial Number: 44079

3. Instrument: WB model GXSF30V water softener Serial Number: AG24625

4. Instrument: Getinge model 533LS sterilizer Serial Number: URA013704 Location: Room 320-E

5. Instrument: Chromalox model GTS30 steam generator Serial Number: 44080

6. Instrument: WB model GXSF30V water softener Serial Number: AG24626

7. Instrument: BMT model SP669-1E sterilizer Serial Number: 5170536

Location: Room 2011

8. Instrument: Miele model PG8583 CD glassware washer Serial Number: 00/074399946 Location: Room 2011

Specific Requirements:

The Contractor shall provide service agreement coverage during each 12-month period including three (3) preventative maintenance (PM) visits and up to six (6) emergency calls per equipment covered with emergency service to begin within 12 hours of call for eight autoclave instruments (Serial Numbers URA013705, 44079, AG24625, URA013704, 44080, AG24626, 5170536 and 00/074399946); specifically,

1. Contractor shall provide preventive maintenance, service repairs including emergency service repairs, and technical support between the hours of 8:00 AM and 5:00 PM of Monday through Friday, excluding Federal holidays.

2. On-site service and repairs shall be performed between the hours of 8:00 am and 5:00 pm on Monday through Friday, except Federal holidays.

3. Contractor shall use only OEM-certified parts and components for all preventive maintenance and repairs, except for consumables, at no additional cost to the Government.

4. Contractor shall be responsible for shipping and handling costs of each autoclave instrument’s replacement parts and components.

5. The Contractor shall provide at no additional cost to the Government all necessary documentation, repair parts, spare parts, accessories, maintenance supplies, special tools, test and support equipment, travel and transportation, personnel skill requirements, and other related services required to maintain each instruments in fully functioning condition, except for costs of repairs occasioned by fault or negligence of the Government.

6. The Contractor shall perform three (3) preventive maintenance on-site inspections during each twelve-month period. Each inspection will evaluate each of the eight autoclave instruments to ensure its operation is substantially in accordance with the following:

Preventive Maintenance for STEAM GENERATORS:

• Check the chamber for signs of leaks;

• Check float chamber for blockage & proper operation;

• Check the auto blow down operation;

• Check the main pressure control switch;

• Check the over pressure safety control switch;

• Check the 5 PSI blow down pressure control switch;

• Check the operation of the elements and wiring;

• Check all the fuses for continuity;

• Check the contactors - replace as needed;

• Indicate the last contactor replacement;

• Check the sight glass condition and for leaks;

• Indicate the last sight glass replacement;

• Check the safety relief valve operation;

• Indicate feed water treatment (RO, softener, none);

• Perform hardness test (post treatment);

• Check inlet solenoid seat for signs of etching;

• Check the pump for proper cycling & sound level;

• Pull level probes and clean (every six months); and

• The parts to be replaced in accordance with the Original Equipment Manufacturer (OEM)

Preventive Maintenance Kit (PM Kit) shall be included in the cost.

Preventive Maintenance for AUTOCLAVES (Sterilizers):

• Check door slide for smooth operation;

• Check door limit switches;

• Test 2 PSI chamber safety switch;

• Check and adjust doors to 1/8" clearance;

• Check door seal/unseal valves & operation;

• Check chamber transducer for correct readings;

• Check water ejector for vacuum good pull;

• Check steam regulator (if present);

• Check door gasket for proper retraction;

• Replace door gasket as needed;

• Test the safety relief valves for operation;

• Check all solenoids - rebuild as needed;

• Check all steam traps for proper operation;

• Check air - in filter - Indicate date last replaced;

• Clean all strainers (chamber and pipe);

• Check door safety switch;

• Check and repair all leaks;

• Check effluent quench system;

• Check control for proper button operation;

• Verify program settings;

• Verify abort routine;

• Run test cycles:

o Liquid with load probe o Hard goods at 135ºC o Wrapped goods o Vacuum leak (yearly)

• Check condition of load rack & shelves;

• Check all cable and wire connections;

• Check printer operation;

• Check printer supplies; and

Preventive Maintenance for WATER SOFTNERS:

• Clean the nozzle and venturi assembly;

• Clean salt storage area; and

Preventive Maintenance for GLASSWARE WASHER:

• Check Electrical safety according to national regulations;

• Check Door mechanism and door seal;

• Check Any screw connections and connectors in the wash cabinet;

• Check Water inlet and drainage;

• Check Internal and external dispensing systems;

• Check Spray arms;

• Check Filter combination;

• Check Sump including drain pump and non-return valve;

• Check All mobile units, baskets, modules and inserts;

• Check Steam condenser;

• Check Wash pressure sensor; and

Government Responsibilities:

Government shall provide contractor access to NCATS facilities: 9800 Medical Center Dr, Rockville MD 20850 and to the rooms in which the units are being serviced. Access will be restricted during federal holidays and after business hours.

Delivery or Deliverables:

The vendor shall perform preventative maintenance service and emergency service and suggest further maintenance as needed. Detailed reports of service performed shall be provided.

The parts to be replaced in accordance with the Original Equipment Manufacturer (OEM)

Reporting Requirements:

The Contractor shall provide one (1) validation report at the completion of each maintenance, repair or service visit for the eight autoclave instruments that describes the services performed on the instruments or components and certifies it to be in fully functioning, good condition.

Other Considerations:

Travel:

Travel costs shall be covered by Contractor at no additional cost to the Government.