CCE STATEMENT of WORK REES_11_18_2021 (1).docx

STATEMENT of WORK (SOW)

1.0 TITLE

Validation, calibration and preventative maintenance service for a Government owned Rees Scientific Environmental Monitoring/Alarm (Centron Presidio) System.

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 therapies for patients enrolled on Clinical Trials at the NIH. In order 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 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. A 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 responsibilities of the Contractor (Rees Scientific) 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 (Rees Scientific) shall provide all the labor, material, equipment and reference standards necessary to maintain the Rees Scientific monitoring/alarm system, as follows

The sensors/probes are monitoring laboratory equipment, including freezers, refrigerators and incubators which contain clinical material, media components, and biologics that are critical to the manufacturing of cell-based 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 installation qualification (IQ), operational qualification (OQ) and validation per GAMP 4 that meets industry and regulatory agency standards for GAMP-4 computerized systems. Approximately 408 points shall be verified and calibrated using a National Institute of Standards and Technology (NIST)-traceable standard/instrumentation, or existing customer calibration instrumentation that is NIST traceable 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 approval by the customer. Qualification/Validation protocols will not be executed prior to approval of protocols. 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 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 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 (IO/OQ and GAMP 4 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 any 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;

· 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 in use shall be tested to ensure proper function;

· All inputs inhibited by Rees Technicians during testing are reset to active status;

· All backup batteries are tested and if needed replaced.

· Risk Based GAMP 4 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 of saved under a different file name for modification.

j. Audit Trial/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. Training

n. 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 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 each 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 OEM parts that are new or remanufactured to OEM specifications. Parts shall be delivered and installed with 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 CCE 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 TYPE OF ORDER

This is a firm fixed price purchase order.

6.0 SEVERABLE SERVICED

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

7.0 PERIOD OF PERFORMANCE

The period of performance shall consist of one (1) 12- month

8.0 PLACE OF PERFORMANCE

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

NIH/CC/DTM/CCE

10 Center Drive Bethesda MD 20892

9.0 PAYMENT

Payment shall be made monthly 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 (Jan 2017) FAR 52.232-25. Highlights of this clause and NIH implementation requirements follow:

I. Invoice Requirements A. An invoice is the Contractor's bill or written request for payment under the contract for supplies delivered or services performed. A proper invoice is an "Original" which must include the items listed in subdivisions 1 through 12, below, in addition to the requirements of FAR 32.9. If the invoice does not comply with these requirements, the Contractor will be notified of the defect within 7 days after the date the designated billing office received the invoice (3 days for meat, meat food products, or fish, and 5 days for perishable agricultural commodities, dairy products, edible fats or oils) with a statement of the reasons why it is not a proper invoice. (See exceptions under II., below.) Untimely notification will be taken into account in the computation of any interest penalty owed the Contractor.

1. Vendor/Contractor: Name, Address, Point of Contact for the invoice (Name, title, telephone number, e-mail and mailing address of point of contact).

2. Remit-to address (Name and complete mailing address to send payment).

3. Remittance name must match exactly with name on original order/contract. If the Remittance name differs from the Legal Business Name, then both names must appear on the invoice.

4. Invoice date.

5. Unique invoice #s for all invoices per vendor regardless of site.

6. NBS document number formats must be included for awards created in the NBS: Contract Number; Purchase Order Number; Task or Delivery Order Number and Source Award Number (e.g., Indefinite Delivery Contract number; General Services Administration number); or, BPA Call Number and BPA Parent Award Number.

7. Data Universal Numbering System (DUNS) or DUNS + 4 as registered in the Central Contractor Registration (CCR).

8. Federal Taxpayer Identification Number (TIN). In those exceptional cases where a contractor does not have a DUNS number or TIN, a Vendor Identification Number (VIN) must be referenced on the invoice. The VIN is the number that appears after the contractor’s name on the face page of the award document.

9. Identify that payment is to be made using a three-way match.

10. Description of supplies/services that match the description on the award, by line billed.*

11. Freight or delivery charge must be billed as shown on the award. If it is included in the item price do not bill it separately. If identified in the award as a separate line item, it must be billed separately.

12. Quantity, Unit of Measure, Unit Price, Extended Price of supplies delivered or services performed, as applicable, and that match the line items specified in the award.*

NOTE: If your invoice must differ from the line items on the award, please contact the Contracting Officer before submitting the invoice. A modification to the order or contract may be needed before the invoice can be submitted and paid.

B. Shipping costs will be reimbursed only if authorized by the Contract/Purchase Order. If authorized, shipping costs must be itemized. Where shipping costs exceed $100, the invoice must be supported by a bill of lading or a paid carrier's receipt.

C. The Contractor shall submit invoice to the National Institutes of Health (NIH)/Office of Financial Management (OFM) via email at invoicing@nih.gov with a copy to the approving official, as directed below. The Contractor must follow step-by-step instructions as stated in the NIH/OFM Electronic Invoicing Instructions for NIH Contractors/Vendors, which is included as an attachment on the website at https://oamp.od.nih.gov/DGS/DGS-workform-information/attachment-files. The invoice shall be transmitted as an attachment via email to the address listed above in one of the following formats: Word, or Adobe Portable Document Format (PDF). The Contractor must submit only one invoice per email. Do not submit supporting documentation (e.g., receipts, time sheets, vendor invoices, etc.) with your invoice unless specified elsewhere in the contract or requested by the Contracting Officer.

The Contractor shall submit a copy of the electronic invoice to the following Technical Point of Contact:

Technical Point of Contact Name- ___TBD at award________________Email Address-

For inquiries regarding the status of invoices, contact OFM Customer Service via email at ofm_customer_service@incontactemail.com or via phone at 301-496-6088. To send your inquiries via other available communication methods refer to the OFM Customer Service website at https://ofm.od.nih.gov/Pages/Customer-Service.aspx.

Note: The OFM Customer Service is open Eastern Standard Time Monday – Friday from 8:30 a.m. to 5:00 p.m. and is closed between 12:00 p.m. to 1:00 p.m.

II. Invoice Payment A. Except as indicated in paragraph B., below, the due date for making invoice payments by the designated payment office shall be the later of the following two events:

1. The 30th day after the designated billing office has received a proper invoice.

2. The 30th day after Government acceptance of supplies delivered or services performed.

B. The due date for making invoice payments for meat and meat food products, perishable agricultural commodities, dairy products, and edible fats or oils, shall be in accordance with the Prompt Payment Act, as amended.

III. Interest Penalties A. An interest penalty shall be paid automatically, if payment is not made by the due date and the conditions listed below are met, if applicable.

1. A proper invoice was received by the designated billing office.

2. A receiving report or other Government documentation authorizing payment was processed and there was no disagreement over quantity, quality, or contractor compliance with a term or condition.

3. In the case of a final invoice for any balance of funds due the contractor for supplies delivered or services performed, the amount was not subject to further settlement actions between the Government and the Contractor.

B. Determination of interest and penalties due will be made in accordance with the provisions of the Prompt Payment Act, as amended, the Contract Disputes Act, and regulations issued by the Office of Management and Budget.

IV. PROVIDING ACCELERATED PAYMENT TO SMALL BUSINESS SUBCONTRACTORS, FAR 52.232-40 (December 2013)

1. Upon receipt of accelerated payments from the Government, the Contractor shall make accelerated payments to its small business subcontractors under this contract, to the maximum extent practicable and prior to when such payment is otherwise required under the applicable contract or subcontract, after receipt of a proper invoice and all other required documentation from the small business subcontractor.

1. The acceleration of payments under this clause does not provide any new rights under the prompt Payment Act.

1. Include the substance of this clause, include this paragraph c, in all subcontracts with small business concerns, including subcontracts with small business concerns for the acquisition of commercial items.