75N91024Q00095_Statement of Work.pdf

STATEMENT OF WORK

Reference# 75N91024Q00095 1

1.0 TITLE

Validation and Calibration Services for a Government-owned Rees Scientific Environmental Monitoring-Alarm System

2.0 BACKGROUND

The U.S. Department of Health and Human Services, National Institutes of Health (NIH), National Cancer Institute (NCI), Center for Cancer Research (CCR), Surgery Branch (SB) has several current Good Manufacturing Practices (cGMP) manufacturing facilities involved in the production of cellular therapies for infusion into patients enrolled in clinical trials at the NIH for which a monitoring system is required. A Rees Scientific T30 environmental monitoring-alarm system is currently installed at NIH. To ensure the safety and integrity of the products and to meet cGMP requirements, equipment used in manufacturing processes must be monitored for performance to ensure the processes have not been compromised. The facilities and equipment in all aseptic processing and cGMP facilities use the REES monitoring system to achieve compliance.

3.0 SCOPE

The Contractor shall provide all labor, material and equipment necessary to maintain the Rees Scientific environmental monitoring-alarm system, as follows:

Item Item/Service Description Quantity 1 Three-point (3PT) calibration of CO2 sensors (CO2-MON-RM3) 125 2 Fire and Ice 3PT calibration (CAL-DIFF-3PT) 110 3 Certified replacement sensor for HUM-RT1 and HUM-RT1-REM transmitters (SNAP-CERT-RT1)

4 3PT onsite-calibration per temperature input, standard sensors

(CAL-3POINT-STD)

5 3PT onsite-calibration per temperature input, ultra-low sensor

(CAL-3POINT-UL)

6 Oxygen 3 sensor head replacement (OXYGEN-3SH) 15 7 3PT onsite-calibration of oxygen sensors (CAL-O2-3PT) 15 8 3PT field calibration of 4-20 mA loops (CAL-LOOP) 420 9 Validation kit, incl. Rees software vers. 3.0 (VAL-KITPRE985) 10 10 Battery module (BATT1720) 1 11 Batteries for wireless transmitters (Z3-BATT-WIFI) 335 12 6 Volt 1.4 Amp batteries (BATT1001) 8 13 12 Volt 4.5 Amp batteries (BATT1709) 16 14 Batteries for micro-units and remote panels (MICRO-BAT) 8

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The sensors are monitoring laboratory equipment, including freezers, refrigerators, incubators, which contain clinical and research material critical to programs in NCI/CCR/SB. The primary monitored parameters are temperature, CO2 levels, and cleanroom air pressures and humidity.

Service shall include installation qualification (IQ) and operational qualification (OQ) that meets industry and regulatory agency standards. Approximately 169 clean room environment points shall be verified and calibrated with National Institute of Standards and Technology (NIST)-traceable equipment, or existing customer calibrations certified in a fashion that meets industry standards and the U.S. food and Drug Administration requirements. The Contractor shall provide full documentation to complete the validation and to meet the needs of regulatory authorities.

The Government shall provide access to the required facilities and equipment as required to perform the outlined work.

All maintenance services shall be performed on-site in accordance with the Original Equipment Manufacturer’s (OEM) most current standard commercial maintenance practices. Onsite and emergency services shall be provided during standard business hours (defined as 8:00 am – 5:00 pm EST, Monday through Friday, excluding Federal Holidays found at www.opm.gov/policy-data-oversight/pay-leave/federal-holidays. Software updates/services may be provided remotely as applicable. All travel, labor, materials, and related charges shall be included in the purchase order price.

4.0 SPECIAL ORDER REQUIREMENTS

The Contractor shall provide all labor, materials, and equipment required to perform the following tasks:

4.1 PREVENTIVE MAINTENANCE

The Contractor shall perform one (1) planned preventive maintenance inspection (PMI) for the entire system (10A, 10B, T30 Node 1 and T30 Node 2) during each 12-month performance period. Service shall consist of a thorough cleaning, calibration, adjusting, inspection, and testing of all equipment in accordance with the manufacturer’s latest established service procedures. All equipment shall be operationally tested through at least one (1) complete operating cycle at the end of the preventive maintenance inspection to assure optimum and efficient performance.

The Contractor shall supply at the completion of the testing, a complete IQ/OQ validation report necessary to satisfy FDA, GMP, GLP, AALAS, AALAC, and other regulatory requirements. As part of the validation, the Contractor shall complete a testing protocol to include the following:

1. All sensors (inputs) are working properly;

2. All sensors, hardwired or wireless, are installed in the correct places as indicated by their

IDs and locations listed for users of their monitored equipment, in the complete Rees node program printout and online;

3. All sensors are reading correctly;

4. All sensors are properly calibrated;

http://www.opm.gov/policy-data-oversight/pay-leave/federal-holidays http://www.opm.gov/policy-data-oversight/pay-leave/federal-holidays

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5. Each piece of monitored equipment shall display a certification label for each sensor.

Writing on the certificate shall be protected against loss of readability following treatment of a room and equipment with cleaning and antiseptic solutions;

6. The system properly identifies an alarm situation;

7. The local alarm system is operational;

8. The remote alarm contacts are functional;

9. The proper voice and data telephone calls are made and emails sent;

10. The system accepts the proper acknowledging signal over the phone;

11. Optional Touch-Screen shall be tested for proper function of the buttons;

12. The Processor, RAM, and PROM shall be tested to ensure that the program is as originally installed;

13. The A/D converter, voice chip, phone interface, display interface, and remote panel communications shall be tested;

14. All output relays that are in use shall be tested to ensure proper function; and

15. Lighting over ride controls (timers) shall be tested to ensure proper function.

For all test results, the Contractor shall complete the test system configuration information and test setup information. The results provided shall show all backup data documenting printouts and appropriate signatures and approvals as required by the FDA and other regulatory agencies.

The FDA and other regulatory agencies consider simple pass/fail signoffs insufficient.

4.2 EMERGENCY SERVICE

On-site, emergency repair service visit shall be provided during each 12-month performance period at no additional cost to the Government. Emergency service shall be provided during normal working hours, Monday through Friday excluding Federal Holidays (see Section 3.0).

Upon receipt of notice that any part of the equipment is not functioning properly, the Contractor shall provide an initial response within one (1) hour, and an on-site response within four (4) hours a qualified service representative to inspect the equipment and perform all repairs and adjustments necessary to restore the equipment to normal and efficient operating condition.

Emergency service calls shall not replace the necessity for planned preventative maintenance.

All labor, travel, and OEM parts shall be included.

4.3 REPLACEMENT PARTS

The Contractor shall furnish all required replacement parts at no additional cost to the Government, with the exception of consumables. All parts shall meet original equipment manufacturer (OEM) specifications. Upon identification of required parts, they shall be delivered within 24 hours, or the following business day should the request fall on a Friday, or preceding a Federal Holiday. If parts will take longer than 24 hours to be delivered for any reason, the Contractor must provide the TPOC with a notification stating the reason and estimated delivery

Reference# 75N91024Q00095 4 timeframe immediately upon identification of delivery delay. All scheduling necessary for servicing and installation of replacement parts shall be communicated with the TPOC.

4.4 SOFTWARE UPDATES/SERVICE

The Contractor shall provide Software Service and updates in accordance with the manufacturer’s latest established service procedures, to include telephone access to technical support for use of program software and troubleshooting of the operating systems, at no additional cost to the Government. The Contractor shall receive advance approval for the installation of all software updates and revisions from the Government. Software service shall include all major software versions, upgrades, updates and Mandatory Safety Releases, installing the most recent version of the covered software. Software service shall include all maintenance release/service pack updates. Defective software shall be replaced at no additional cost to the Government.

4.5 TECHNICAL PHONE SUPPORT

The Contractor shall provide at no additional cost to the Government unlimited clinical technical telephone support during standard business hours for troubleshooting for the instrument and clinical application support (8am – 9pm Monday through Friday), excluding Federal holidays.

4.6 FIELD SERVICE REPORTS

The Contractor shall capture all services provided in a Calibration and Maintenance Protocol, and provide a Field Service Report by email to the TPOS within three (3) business days of any services performed on equipment or software covered under this requirement. The FSR shall include at a minimum the following information:

1. Contractor’s Name;

2. Equipment Model and Serial Number;

3. Technician’s name, telephone number, and signature;

4. Date and Time at which services were performed;

5. Summary of work performed;

6. As applicable: summary of malfunction/issue; malfunction that occurred, the repair efforts, and the duration that was required to restore the equipment to operation;

7. As applicable: reason for software updates, and any effect it may have on equipment operation;

8. Certification that the equipment is fully operational.

The FSR shall be delivered in Microsoft Office Word or Adobe PDF format, unless prior approval for another format has been obtained from the TPOC.

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4.7 SERVICE EXCLUSIONS

The Contractor shall not be responsible for any repairs necessitated by abuse, neglect, vandalism, Acts of God, fire or water. Should damage occur as a result of the aforementioned events, the Government reserves the right to obtain repairs needed as a result of such events via a modification to the purchase order, under a separate purchase order, or any other method deemed appropriate and in accordance with Federal Acquisition Regulations.

4.8 PERSONNEL QUALIFICATIONS

Only fully authorized, trained and certified by Rees Scientific, Good Manufacturing Practice (GMP) trained personnel, shall perform service on the Rees Scientific environmental monitoring system at the NIH, as covered by this purchase order. All primary service personnel shall have at least one backup support person with at least the same level of expertise on the Rees Scientific environmental monitoring system covered under this purchase order.

4.9 USER TRAINING

The Contractor shall provide refresher training to SB staff during onsite maintenance visits.

5.0 TYPE OF ORDER

This shall be a firm fixed-price purchase order.

5.1 SEVERABLE SERVICES

The services acquired under this purchase order are severable services. Funds are only available for use for the line item to which they are obligated. Unused funds from one period (line item) may not roll over for use in other periods.

6.0 PERIOD OF PERFORMANCE

The Period of Performance shall consist of one (1) 12-month base period and four (4) 12-month option periods as follows:

Base Period September 7, 2024 – September 6, 2025 Option Period 1 September 7, 2025 – September 6, 2026 Option Period 2 September 7, 2026 – September 6, 2027 Option Period 3 September 7, 2027 – September 6, 2028 Option Period 4 September 7, 2028 – September 6, 2029

7.0 PLACE OF PERFORMANCE

Onsite services shall be performed at the following location:

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NIH/NCI Surgery Branch 9000 Rockville Pike Bethesda, MD 20892

Note that access to the NIH campus is restricted. As such all contractor personnel will be required to access campus via designated entrances where they are subject to security screening.

Also, due to the current COVI-19 Pandemic there maybe additional access restrictions. Please refer to the NIH Security and Access site for more details: (www.nih.gov/about-nih/visitor-information/campus-access-security).

8.0 INSPECTION AND ACCEPTANCE

Pursuant to FAR clause 52.212-4, all work described in the SOW to be delivered under this purchase order is subject to final inspection and acceptance by an authorized representative of the Government. The authorized representative of the Government is the NCI Technical Point of Contact (POC) who is responsible for inspection and acceptance of all services, materials, or supplies to be provided by the Contractor.

Regardless of format, all digital content or communications materials produced as a deliverable under this purchase order, shall conform to applicable Section 508 Standards to allow Federal employees and members of the public with disabilities to have access to and use of information and data that is comparable to the access to and use of information and data by Federal employees or by members of the public who are not individuals with disabilities. Remediation of any materials that do not comply with the applicable Section 508 requirements as set forth below, shall be the responsibility of the Contractor.

HHS guidance regarding accessibility of documents can be found at:

https://www.hhs.gov/web/section-508/making-files-accessible/create-accessiblepdfs/index.html.

Federal Government-wide guidance regarding accessibility of documents can be found at https://www.section508.gov/, including the documents describing the preferred method of authoring and testing documents produced in Microsoft Word 2013 or later, Microsoft Excel, and files formatted as PDF.

9.0 TECHNICAL POINT OF CONTACT

The Technical Point of Contact (TPOC) is responsible for inspection and acceptance of all work in relation to this requirement, and will serve as the Governments primary point of contact throughout the duration of the requirement. All efforts must be coordinated with this individual.

The TPOC for this requirement is:

Name: [TBD UPON AWARD] Email:

Phone:

https://www.nih.gov/about-nih/visitor-information/campus-access-security https://www.nih.gov/about-nih/visitor-information/campus-access-security

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Note: The TPOC has limited authority as defined within this Statement of Work. They do not have the authority to commit or obligate Government funds, or make changes to the terms and conditions of the purchase order. As such, any changes to the purchase order must be performed by a warranted Government Contracting Officer with appropriate delegated authority to do so.

10.0 PAYMENT

Payment shall be made quarterly in arrears. Payment authorization requires submission and approval of invoices to the COR and NIH OFM, in accordance with the payment provisions listed below:

The following clause is applicable to all Purchase Orders, Task or Delivery Orders, and Blanket Purchase Agreement (BPA) Calls: PROMPT PAYMENT (JUL 2013) FAR 52.232-25.