Attach 01 PWS Getinge Sterilizer Autoclaves Certification and Maint Service.pdf

United States Department of Agriculture Agricultural Research Service

PERFORMANCE WORK STATEMENT

Getinge Sterilizer Autoclaves Annual Certification & Maintenance Support

National Bio and Agro-Defense Facility (NBAF) USDA-ARS, Manhattan, KS

2/10/2023

Project Getinge Sterilizer Autoclaves Annual Certification & Maintenance Support

General Information

1.0 Scope of Work

The contractor shall provide annual certification and maintenance support for 30 sterilizers autoclaves located in the NBAF main lab. Additionally, the contractor shall provide documentation (certification, supporting records, and measurement uncertainties) that the equipment has been annually certified. The sterilizer autoclaves systems are in a containment portion of the facility, so the contractors will have to work in containment. The contractor’s key personnel need to be certified Getinge technicians to perform the certification and maintenance support on Getinge equipment.

2.0 Background

The National Bio and Agro-Defense Facility (NBAF) is seeking a company with extensive knowledge of certification and maintenance support on Getinge sterilizers autoclaves. NBAF is designed to contain bio safety level (BSL) -2 through BSL-4 research studies. Contractors associated with maintenance of the facility should fully understand the construction types and maintenance methods associated with these facilities. The sterilizers autoclaves are located throughout the facility. Three are in BLS-2, 17 are in BLS-3, four are in the BSL-3Ag space, two are in BSL-4, and four are in the biologic development module. Downtime of the sterilizers autoclaves during services shall be kept to a minimum. The facility will be occupied during this work. The NBAF campus address is 1980 Denison Ave., Manhattan, KS.

3.0 Contractor Requirements

3.1 Work Restrictions & Conditions

3.1.1 Site Security Access: Access to the site is controlled by a security fence and visitor/contractor check-in/check-out system. All contractor/subcontractor employees shall sign-in and out at the main entrance gate and always wear a contractor/visitor identification badge while on the site. The ID badges will be turned in at the end of the workday. A current government-issued identification with a picture ID is required for entry. See 8.0 for additional security information.

3.1.2 All persons accessing the site must complete the approximate two hour, NBAF Site Security and Safety Orientation. Site specific bio agent training is currently being developed. If development is completed during the duration of this contract the training may be required for all persons accessing the site.

3.1.3 Limited number of vehicles will be allowed access adjacent to the work; contractor employee’s personal vehicles shall be parked in the facilities main parking lot.

3.1.4 Work shall be confined to the areas identified on the Drawings. Unless accompanied by a USDA employee, the Contractor, subcontractors, and their employees shall not enter buildings or facilities not specifically part of this project. Reasons included, but are not limited to, disease control and health requirements.

3.1.5 Failure to comply with access requirements shall be adequate grounds for removal of the Contractor/subcontractor employees from the site and barring further site access to individuals.

3.1.6 Since this work is in containment it may require the technician’s that enter containment to get Select Agent Registration (SRA) background check.

3.1.7 Badged escorts are a requirement of the contractor to escort their own personal for this contract.

3.1.8 Work Hours: Regular work hours for the site are 6:00 am to 6:00 pm, Monday through Friday, excluding Government holidays.

3.1.9 Federal Holidays are listed below:

New Year’s Day Labor Day Martin Luther King Jr.’s Birthday Columbus Day President’s Day Veteran’s Day Memorial Day Thanksgiving Day Independence Day Christmas Day Juneteenth Independence Day

3.1.10 Work Outside Regular Work Hours: Work scheduled outside regular work hours including late hours, Saturdays, Sundays, and Government holidays requires Security approval in advance. Make application thru the COR at least 5 calendar days prior to such work to allow arrangements to be made by the Government for access to the work area and inspection & monitoring arrangements. Requests shall include the exact dates, hours, location, and purpose of the exception. If approved, the COR will coordinate access with the site security office.

3.2 General Requirements / Tasks

3.2.1 The Contractor shall furnish a detailed cost proposal for base plus four (4) years for an overall five (5) year contract, including all prime and sub pricing showing labor cost, material cost, OH and Profit and estimated service times including crew size, to provide material and services as specified in the scope of work. Proposal shall indicate how many site visits are anticipated to complete the work and any associated travel costs.

Proposal must be in whole dollars, no cents. Otherwise, bids will be rounded to the nearest dollar.

3.2.2 The Contractor is responsible for visiting the site prior to submitting a bid to observe existing conditions. No compensation will be provided for conditions that would be visible during an on-site visit for persons experienced performing this type of work.

3.2.3 Bid or performance bonds may be required per the Contracting Officer’s bid package.

Obtaining and the cost of these bonds is the responsibility of the Contractor. Proof of Insurance will also be required.

3.2.4 Where governing regulations and imposed codes and standards require notices, permits, licenses, inspections, tests, and similar items or actions to lawfully proceed with the required work, the Contractor shall obtain items and take those actions in accordance with the regulations of the governing authority. The costs of such permits, licenses, inspections, etc., are the obligation of the Contractor.

3.2.5 The Contractor’s work shall adhere to the criteria stated within these project requirements, drawings, and specifications. All services shall comply with applicable federal, state, and local code requirements as well as current industry standards, (i.e.:

UBC, NFPA, UL, ACI, ANSI, FCC, ASTM, NEC, NEMA, etc.) and health and safety codes, in effect at the time of Task order award, or as determined by the authority having jurisdiction.

3.2.6 All work must meet ARS 242.1M P&P titled “ARS Facilities Design Standards” found at https://www.afm.ars.usda.gov/ppweb/pdf/242-01m.pdf, in addition to meeting all Local, State and Federal codes, and latest IBC codes.

3.2.7 Prevailing Wage Rates may apply. If applicable employee payroll logs for the project will be required to verify wage rates are being adhered to.

3.2.8 There should be no need for a service trailer at the jobsite. Contractor may store equipment tools, materials onsite as needed for the project in a contractor provided, locked job-box.

3.2.9 The Contractor shall work with Facility personnel to ensure project is accomplished in a timely manner.

3.3 Pre-Service/Repair Requirements / Tasks

3.3.1 Prior to Services Notice to Proceed (NTP) the following submittals must be submitted to the Contracting Officer (CO) for approval, unless otherwise determined by the CO that submittals may be provided after NTP. Documents shall be submitted in PDF that can be easily read when printed on 8-1/2 x 11 or 11 x 17 sheets. Contractor is responsible for any costs incurred for equipment ordered without prior approval:

3.3.1.1 Product Data, Shop Drawings, Installation instructions, and SDS Submittals for all Material used on this project. SDS for all chemicals that will be used shall be provided prior to being brought onsite. Submittals shall be annotated/highlighted to show products’ conformance with SOW requirements. If multiple items are listed on a submittal, the specific items being submitted for use shall be annotated/highlighted for clarity.

3.3.1.2 Service schedule indicating work hours, include the daily starting and stopping time, and days of the week the Contractor proposes to carry out the work. Schedule shall cover the anticipated duration of work to complete the project.

3.3.1.3 Accident Prevention Plan/Site Specific Safety Plan is NOT required on this service.

3.3.1.4 Quality Control Plan is NOT required on this service.

3.3.1.5 Individual Environmental Protection Plan is NOT required on this service.

3.3.1.6 The Contractor shall provide to the CO a list of Task order personnel of the general and subcontractors, who will be emergency contacts, including address, and telephone numbers for use in an emergency. The Contractor shall update and submit the list monthly with invoices.

3.4 Service/Repair Requirements / Tasks

3.4.1 Provide annual certification on all Laboratory Sterilizer Autoclaves Instrumentation, Controls, Software, and all Equipment as required to meet manufacturer's recommendations.

https://www.afm.ars.usda.gov/ppweb/pdf/242-01m.pdf

3.4.2 We need 20 hours remote support via phone and five (5) eight (8) hour days on site support for assistance conducted during normal operating hours and performed by either a service technician or programming engineer per year.

3.4.3 Provide a daily report indicating assets serviced and results. The report shall indicate any issues or components that need to repaired/replaced.

3.4.4 Provide certification reports, including supporting records and measurement uncertainties, for all Laboratory Sterilizer Autoclaves, reflect the work was done in accordance with the appropriate ISO standard.

3.4.5 Update service schedule to reflect current and projected progress, frequent enough to be of timely use for project management and coordination. Submit updates with each invoice.

3.4.6 Existing Installations / Demolition

3.4.6.1 All disturbances of existing systems shall be thoroughly coordinated with the Owner to prevent disconnecting equipment that might jeopardize on-going research.

3.4.6.2 Owner reserves the right to retain any equipment / materials removed as part of the scope of work. Contractor shall coordinate any equipment / materials to be retained with Owner prior to starting demolition operations.

Contractor shall legally dispose all equipment / materials removed that will not be retained.

3.4.7 Building will be occupied while service is ongoing. Contractor shall schedule work with location to allow location to meet current scientific and research needs.

3.4.8 Shutoff of utilities, if required, shall be scheduled no less than five (5) working days in advance.

3.4.9 The Contractor shall protect the work, the site, and all existing property and structures within the limits of the service activities or that may be affected thereby until acceptance of the work. Any damage to property shall be repaired at the Contractor’s expense, to pre-damaged condition to the satisfaction of the COR.

3.4.10 The work performed under this contract shall be subject to continuous audit by the

CO/COR/LM. Quality control is the exclusive responsibility of the Contractor.

3.4.11 Safety and health matters, as they relate to the work, are the exclusive responsibility of the Contractor. The Contractor shall furnish, erect, and maintain barricades, warning lights, signs, guards, or take other precautions as may be required by law or local authorities of the protection and security.

3.4.12 The contractor shall follow the site lock-out/Tag-out policy and coordinate implementation of LOTO with the facility as needed.

3.4.13 The material and equipment to be furnished under project shall be the standard products of manufacturers regularly engaged in the production of such materials and equipment and shall be the manufacturer’s latest standard design.

3.4.14 All materials and equipment to be incorporated in the work shall be handled and stored by the manufacturer, fabricator, supplies, and Contractor before during and after shipment in a manner to prevent warping, twisting, breaking, chipping, rusting and any injury, theft, or damage of any kind to the materials and equipment. All materials and equipment furnished by the Contractor shall be new and subject to inspection and approval by the CO/COR.

3.4.15 Submit to the CO/COR documentation of hazardous materials/waste disposed or recycled.

3.4.16 The work site shall always be kept clean and free of debris. Disposal of the old material or equipment is required. Restore disturbed areas to original like appearance and conditions. Upon completion of the project, and prior to final inspection, the Contractor shall remove from the premises all unused material, trash, and debris resulting from the work to the satisfaction of the COR.

3.4.17 Contractor to provide standard warranty from deficiencies and defects. Warranty information shall include the warranty period (dates), and warranty contacts with names, addresses and telephone numbers.

3.4.18 Prior to submitting final payment, the following documents shall be submitted:

a. General contractors’ warranty on work

b. Certification documentation

c. Release of liens as applicable

d. Employee payroll\time sheets

e. Invoice

4.0 Government Furnished

4.1 The Government shall be afforded 14 calendar days review periods for submittals requiring approval and 7 calendar days for information only submittals.

4.2 The Government will furnish a reasonable amount of electricity and water if requested. Access to a toilet facility will be provided by the Government.

5.0 Deliverables / Schedule

The Contract duration for this project is 365 calendar days from Notice to Proceed issued by Contracting Officer.

Key Deliverables

Item No.

Deliverable / Item Title

Description Frequency Reference Delivery Format

Due By

1 Payrolls Certified payrolls Once per invoice request

Ref. SOW, Page 4, Section 3.2.7

PDF to

CO/COR

Each invoice submission

2 Submittals Product data sheets, shop drawings, installation instructions, SDS

Once per product

Ref. SOW, Page 5, Section 3.3.1.1

PDF to

COR

Prior to Service/Repair NTP

5 Emergency Contact List

Emergency contact info for persons working onsite

Preservice and monthly

Ref. SOW, Page 5, Section 3.3.1.6

PDF to

COR

Prior to Service/Repair NTP & with each invoice

6 Daily Reports Document and photo describing daily activities

Each day of work

Ref. SOW, Page 6, Section 3.4.2

PDF to

COR

Within 24 hrs. after the date(s) covered by the report

8 Service Schedule

Schedule indicating work hours and days planned to work

Preservice & at a minimum with each invoice

Ref. SOW, Section 3.3.1.2, & 3.4.4

PDF to

COR

Prior to Service/Repair NTP & with each invoice

9 Closeout Documents

Warranty, As-builts, O&Ms, Release of liens

Once Ref. SOW, Page 7, Section 3.4.17

PDF to

CO/COR

Prior to final payment

6.0 Travel

There are no anticipated travel requirements. If travel costs, flights and per diem, are needed to get technicians to the facility for services they shall be reflected on a separate cost line.

7.0 Contractor’s Key Personnel

The contractor’s key personnel need to be certified Getinge technicians to perform the certification and maintenance support on Getinge equipment.

8.0 Security Requirements

8.1 Personnel employed by the Contractor or any representative of, or agent of the Contractor, entering this facility shall conform to the facility security regulations. The Contractor shall provide all information required for background checks to meet facility access requirements as performed by the facility security office. Contractor personnel shall comply with all personal identity verification requirements as directed by USDA-ARS Security office. Each person accessing the site will be required to provide personal details, (full name, DOB, SSN, DL#) and will undergo a routine background check, such as a National Agency Check with additional inquiries, which may include a criminal and credit check. Details required for the check should be submitted the security office NLT 5 days prior to the visit. Results of this check may return earlier. However, it should not be planned to have results earlier than 5 days. If, while on site the contractor/vendor will have access to sensitive information, they must complete a National Disclosure Agreement (NDA), along with the required training. This training will most likely be completed by reviewing a series of slides covering the topics of the definition of controlled unclassified information (CUI), access, handling, distribution, storage, and destruction of CUI. Each person will acknowledge receiving and understanding the training on the NDA. The process should not exceed two hours. Acknowledgement and completion of the NDA will be turned in with the form required for the background check. Results will be returned through the Contracting Officer or Contracting Officer Representative. Contractors needs to follow Title 41, Code of Federal Regulations, Part 102- 74, Subpart C Rules and Regulation Governing Conduct on Federal Property.

8.2 Additional security requirements may be imposed when the Federal Government raises the Homeland Security Alert Level. Additional directions will be provided if the situation occurs.

8.3 The Contractor shall safeguard all USDA-ARS equipment, information and property provided for Contractor use. At the close of each work period, USDA-ARS facilities, equipment, and materials shall be secured.

9.0 Data Rights

Not Applicable

10.0 Section 508 – Electronic and Information Technology Standards Not Applicable

Attachment Attachment A – Sterilizer Autoclaves