P09-25-000074 Draft Rees Environmental Monitoring SOW.pdf

STATEMENT of WORK

1.0 TITLE

Rees Scientific Environmental Monitoring/Alarm (Centron Presidio) System validation, calibration, and preventative maintenance services.

2.0 BACKGROUND

The U.S. Department of Health and Human Services, National Institutes of Health (NIH), Clinical Center (CC), Department of Transfusion Medicine (DTM), Center for Cellular Engineering (CCE) operates several current Good Manufacturing Practices (cGMP) facilities which are utilized to manufacture cellular and gene therapies for patients enrolled on Clinical Trials at the NIH. To be compliant with 21CFR 211.67 (Current Good Manufacturing Practice for Finished Pharmaceuticals, Subpart Equipment Maintenance and Cleaning), a service contract is required for the Rees Scientific Environmental Monitoring System that monitors the environmental conditions within facilities used to manufacture cell therapies, as well as the performance of all critical equipment used in manufacturing and storage of cell therapies. The Rees Scientific environmental monitoring system is installed in the 3T, 2J and T10B facilities operated by the CCE to meet this requirement. This Statement of Work details the tasks and contractor responsibilities in providing support services including annual validation, calibration and preventative maintenance required to maintain the monitoring system used by the CCE in its manufacturing facilities.

3.0 SCOPE

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

Item Item/Service Description Quantity 1 Validation Kit for New Systems and existing systems with Rees Software Ver.

3.0 Build 1020.0.24 or 1021.0.9 or higher

2 ISO 17025 Certified replacement sensor for Z3 TH transmitters. Includes 3 Pt.

ISO17025 Traceable Certificate for humidity at a single temperature. To add on 3 point temperature calibration see CAL-CERT-PLUS part number.

3 ISO 17025 Certified replacement sensor for HUM-RT1 and HUM-RT1-REM transmitters. Range -40 to 85 C and 0-100% RH Accuracy +/- 1%. Uncertainty of calibration .95%. Includes ISO17025 Traceable Certificate for 3 points of humidity and 3 points for temperature.

4 Three point Temperature add-on to calibration of certified Z3-T/H series combination temperature/ humidity sensors. Includes 3 point ISO17025 traceable certificate for temperature to supplement the humidity certificate already included with the purchase or replacement of a certified humidity sensor.

5 Three Point IS0-17025 field calibration of differential pressure sensors.

Includes calibration certificate. (Excludes Z3-DP sensors).

6 Three Point Calibration of CO2-MON-RM3 Sensor using customer provided equipment. Customer must be available to set equipment at various environmental calibration levels.

7 Calibrated trade-out Oxygen-Room Sensor. Includes new O2 sensor head.

Requires customer to return existing sensor for reconditioning.

8 Replacement sensor head for OXYGEN-TOXGARD. Range 0-25%. Requires on-site calibration; see part numbers CAL-O2-3PT, CAL-OXYGEN-LRG, or CAL-

OXYGEN-SML.

9 Three point onsite calibration of Oxygen sensors. Calibration kit. Maximum of 3 sensors can be calibrated using provided equipment. Calibration bottles used during the calibration will be left onsite for customer disposal.

10 3-Point Onsite Calibration per input. Includes 3-point traceable calibration certificate. Calibration are performed using a calibrator to simulate calibration points, followed by a single operating point verification.

11 Field calibration of the 4-20 mA loop at 3 Points to Ensure Overall System Accuracy Using a Certified 4 to 20 mA Sensor.

12 Documentation of As-Found value prior to calibration or change/removal of existing probe. The probe data form will include both the current probe’s Rees system reading and the reading from an independent reference instrument

13 6 Volt 1.4 AMP battery 15 14 12 Volt 4.5 AMP battery 30 15 Battery for Micro Units & MPX-RMT Remote Panels 15 16 3.6-volt Lithium Battery for Z3-RTD wireless transmitters. 16 17 3.6-volt Lithium Battery for Z3 wireless transmitters. 23 18 Batteries for Z3 Wi-Fi wireless transmitters. 248 19 Comprehensive Once Yearly OQ of system with full documentation provided to satisfy regulatory authorities. Comprehensive system test verifies, calibrates, and documents all system functions including readings, databases, alarms, dial-outs, outputs, reports, and user programming. Includes One Year Onsite Service Plan with 24/7 Technical Support. Includes approximately 100-page GMP/GLP OQ validation report, 1000-page software validation test report, calibration of temperature and humidity with traceable equipment, copies of reference equipment calibration certificates and onsite refresher training at PM visit. Payment due in full upon receipt of order. Customer Responsible to Approve and Review all Validation Documentation prior to Technicians Departure. Any Subsequent Corrections Could Involve Additional Charges.

The sensors/probes are monitoring environmental conditions, including temperature, humidity, and pressure; and laboratory equipment, including freezers, refrigerators and incubators which contain clinical material, media components, and biologics that are critical to the manufacturing of cell-based and gene therapies by the CCE for NIH sponsored clinical trials. The primary parameters that are monitored are Temperature, Humidity, Differential Air Pressures, CO2 and O2 Levels. Service shall include operational qualification (OQ) and validation per GAMP-5 that meets industry and regulatory agency standards for GAMP-5 computerized systems. Approximately 399 points shall be verified and calibrated using a National Institute of Standards and Technology (NIST)-traceable standard/instrumentation that meets industry standards and the US Food and Drug Administration mandates. All calibrations will include “as-found” and “as-left” measurements for any calibrations performed. All qualification/validation protocols will be reviewed and agreed upon prior to execution. Qualification/Validation protocols will not be executed prior to approval of protocols by CCE Quality Assurance. The Contractor shall provide full documentation to complete validation that meets the needs of regulatory authorities. The Government shall provide access to the required facilities and equipment as required to perform the outlined work. All routine onsite service shall be provided during standard business hours, defined as 7:00am-5:00pm EST, Monday through Friday, excluding Federal Holidays found at: https://www.opm.gov/policy-data-oversight/pay-leave/federal-holidays/. Service shall be performed in accordance with the original equipment manufacturer’s (OEM) most current commercial maintenance procedures by OEM-authorized and trained service personnel. All travel, labor and related charges shall be included.

The Contractor shall provide unlimited clinical technical toll-free telephone support (24 hours/day, 7 days a week) for troubleshooting the system and clinical application support (Monday-Friday 8:00am to 9:00p, EST), excluding Federal Holidays. Technical support shall be provided OEM authorized and trained service personnel.

4.0 TASKS

4.1. PREVENTATIVE MAINTENACE

The Contractor shall perform at least one (1) validation, which includes preventative maintenance inspection (PMI) for the entire system (Nodes 3, 4, 5 and 6), during the 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 operating cycle at the end of preventative maintenance inspection to ensure optimum and efficient performance.

The contractor shall supply copies of all protocols for preapproval by CCE quality assurance prior to execution.

The Contractor shall supply at the completion of testing a complete (OQ and GAMP-5 re-validation) validation report that satisfies FDA, cGMP, GLP and other applicable regulatory requirements. As part of the validation, the Contractor shall complete a testing protocol to include the following.

• Provide documents for Technical and Quality review/approval two weeks in advance of execution.

• Execute and document work in a contemporaneous and complete manner and shall indicate to the end user of any errors/gaps in the event work cannot be continued or completed.

• All Sensors (inputs) are working correctly.

• All sensors, hardwired or wireless, are installed in the correct places as indicated by their unique IDs and locations listed for users of the monitored equipment in the complete Rees node program printout and online.

• All sensors are reading correctly.

• All sensors are fully calibrated.

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

Writing on the certificate shall be protected in a manner that maintains legibility following cleaning of the rooms and equipment with cleaning and disinfection agents.

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• The system is able to properly identify an alert and alarm situation for each probe.

• The local alarm system is operational.

• The remote alarm contacts are functional.

• The proper voice and data telephone calls are made upon alarm, and e-mails are sent upon alert.

• The system accepts the proper alarm acknowledgments over the phone.

• The processor, RAM and PROM shall be tested to ensure that the program is as originally installed.

• The A/D converter, voice chip, phone interface, display interface, and remote panels communications shall be tested.

• All output relays that are in use shall be tested to ensure proper function.

• All inputs inhibited by Service Technicians during testing are reset to active status.

• All backup batteries are tested and replaced if battery life is determined to be less than 12 months.

• Risk Based GAMP-5 Methodology/Validation as follows:

• Use of GAMP Methodology: Risk Based Approach to deploy and maintain GxP compliance for computerized systems (This methodology is outlined by ISPE for Good Automated Manufacturing Practice (GAMP)

a. Verification of risk that notifications such as alarms and alerts are electronically routing to the appropriate location and risk if path is blocked (backup path for notification based on simulation of blocked path).

b. Disaster Recovery: Risk based on disaster and Continued Business Strategy

c. Verification for true Electronic Records and eSignatures (ERES) and verification of change with reason

d. Storage of electronic data used in GMP mandated records

e. Verification of change with required change control and authorization

f. 2nd Verification of changes

g. Check of invalid or altered data (Audit Trail)

h. Verification of Administrative privileges/User Roles.

i. Verification that recorded data cannot be modified/deleted or saved under a different file name for modification.

j. Audit Trail/Backup of datalogger. (Usually EEPROM)

k. Disaster Recovery

i. Loss of communications (backup system)

l. Closed System in compliance with NIH security requirements and requirements for a secure system.

m. Validation of creation of accurate records as these records are used to generate reports for tracking and trending.

i. Ensure accuracy, reliability, consistent performance and discerning of invalid or altered records.

• Project Phase Validation

a. Review and approval of calibration, validation, and other technical documents/general reports prior to submission to NIH.

b. Delivery of Validation Documentation

c. Change Control records throughout lifecycle of the system.

d. Deviation Reports

e. Risk Assessments

f. IT infrastructure support as needed based on changes.

For all test results, the Contractor shall complete the test system configuration information, and the test setup information. The results provided shall show all backup data documenting printouts and appropriate signatures and approvals as required by the Food and Drug Administration (FDA) and other regulatory agencies. The FDA and other regulatory agencies consider simple pass/fail signoffs as insufficient.

4.2. EMERGENCY SERVICE

On-site emergency repair service visits shall be provided during the 12-month performance period at no additional cost to the Government. 24-hour Emergency Service shall be provided. Upon receipt of notice that any part of the system is not functioning properly the Contractor shall, within one (1) hour, provide an initial response via phone/e-mail; and within four (4) hours, provide onsite service personnel 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 of planned preventative maintenance.

4.3. REPLACEMENT PARTS

The Contractor shall furnish all required replacement parts at no additional cost to the Government, with the exception of consumables. Parts shall be genuine original equipment manufacturer (OEM) parts that are new or remanufactured to OEM specifications. Parts shall be delivered and installed within 24 business hours, or the next business days should the request fall on a Friday or a day preceding a Federal Holiday. All scheduling necessary for servicing and or installation of replacement parts shall be communicated with the CCE technical point of contact.

4.4. SOFTWARE UPDATES/SERVICE

The Contractor shall notify the POC assigned to this project of any changes and/or updates to the software with details of changes/updates and provide Software Service and updates in accordance with the manufacturer’s latest established service procedures, to include telephone and onsite 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. Defective software shall be replaced at no additional cost to the Government.

The Contractor shall provide unlimited clinical technical toll-free support for troubleshooting for the system and clinical application support, in accordance with the section 3.0.

4.5. Service Exclusions

The Contractor shall not be responsible for any repairs necessitated by abuse, neglect, vandalism, natural disasters, fire, or water. These repairs shall be the subject of a separate purchase order and shall not be performed under this purchase order.

5.0 PERIOD OF PERFORMANCE

The anticipated period of performance shall consist of a twelve-month period of performance.

PLACE OF PERFORMANCE

National Institutes of Health Clinical Center Department of Transfusion Medicine Center for Cellular Engineering 10 Center Drive Building 10, Room TBD Bethesda MD 20892

Rooms: Onsite services include the following facilities locations. 3T, 2J and T10B cGMP facilities located at the Clinical Center

6.0 PAYMENT

The contractor shall provide a copy of the monthly invoice by email to the technical point of contact assigned to this project.

Technical Point of Contact:

Name- TBD Email: TBD T-(301)