632-19-106 SOW_USP 800 Trailer Project_REVISED_11-07-22.docx

11/04/22 USP 800 Pharmaceutical Mobile Unit (Trailer) Rental 632-19-106 Statement of Work A. General Requirements and Background This project entails the rental of an approximately 55 ft. long by 9 ft. wide, USP-800 compliant Mobile Pharmaceutical Unit (Trailer) with hazardous drugs storage space by the Northport VA Medical Center (Northport VAMC). The layout of this mobile unit will include a USP 800 Buffer Room (HD Compounding Room), an USP 800 Ante Room to the Buffer Room, and a Hazardous Drug Storage Room. There may also be an Entry Room so as to help ensure that the environmental conditions are maintained in the rooms listed above. The unit is to have a mechanical/electrical/utility space accessible from outside of the trailer. Appropriate workstations, casework, walls, ceilings, and flooring will be integrated into this unit. The work covered under this contract consists of furnishing all labor, materials, tools, equipment, training, CETA certification, supervision and necessary transportation to provide a fully functional and complaint USP 800 Pharmaceutical Mobile Unit with hazardous drug storage space. The mobile unit will be installed at a location adjacent to the rear entrance of Building 11.

This procurement is part of a larger rehabilitation effort to reconstruct existing medical space to comply with USP 800 requirements. As such, the need for this mobile unit will be temporary. A base year and two option years are to be included. Therefore, this procurement is stipulated for the rental of a mobile unit in tandem with a maintenance service contract, and not for its purchase.

Northport VAMC requires the Pharmaceutical Mobile Unit (Trailer) to be delivered and mobilized, having obtained CETA Certification and fully and completely operational no later than 5/12/23. All recertification is the responsibility of the vendor/contractor.

B. Special Requirements Prior to delivery and installation of this mobile unit, the vendor/contractor shall visit the site and familiarize themselves with the existing conditions. The contractor shall perform all utility connections during mobilization and provide service and corrective maintenance on all supplied equipment during the rental period. Northport Engineering will provide necessary assistance for MEP (mechanical, electrical, plumbing) connections. Contractor shall be responsible for providing repairs of faulty equipment within 24 hours, and shall also be responsible for contacting local certifier(s) for repairs, testing, or issues with faulty equipment at no additional cost to the Northport VAMC. Contractor will be responsible for arranging and obtaining CETA certification of the mobile unit (and Bio Safety cabinets) as USP 800-compliant prior to use. Contractor will also be responsible for the demobilization and removal of the mobile unit upon contract completion.

C. Engineering Requirements

1. HVAC Design Requirements: HVAC equipment shall include a redundant (N + 1), HVAC system, fan filter (HEPA) units to provide the required level of filtration and reheat coils for individual room temperature control. The HVAC system shall be equipped with a humidifier in order to comply with the following space design requirements:

2. Heating, Ventilation and Air Conditioning (HVAC) shall be required in the trailer to maintain a required temperature, relative humidity, air change quantities and relative room pressure relationships, as called out in USP 800 and the VA HVAC Design Manual (the more stringent of the two will apply) while operating at the Northport, NY ambient design conditions as indicated in the HVAC Design Manual (https://www.cfm.va.gov/til/dManual/dmHVAC.pdf), 88.5 deg. F dB/ 73.4 deg. F wB summer and 11.5 deg. F dB winter. The temperatures stated above are based on data indicated in the current edition of the Manual, which is dated March 1, 2022, as of the writing of this document.

3. USP800 Buffer Room (HD Compounding Room): The HVAC design criteria shall be as follows: 35 ACH, 68°F room temperature, 30-55% Relative Humidity (RH), and negative pressure with respect to the Ante Room.

4. USP800 Anteroom to the Buffer Room: The HVAC Design Criteria shall be as follows: 35 ACH, 68 °F room temperature, 30-55% RH, positive pressure with respect the Buffer Room (HD Compounding Room) and the entry room.

5. Hazardous Drug Storage Room: The design criteria shall be as follows: 12 ACH, 68 °F room temperature, 30-55% RH, Negative pressure with respect to the Anteroom and the Entry Room into the trailer. There are no specific design requirements for the Entry Room, however the space must be conditioned so as not to be detrimental to the ability to maintain the adjacent spaces at the environmental and other conditions listed above.

6. Trend Log Data Reports: The contractor shall provide via an Adobe Acrobat (pdf-format) and Excel spread sheet format trend log data reports in graphical and tabular form in an auto generated email to be received by 12:30am the following day. The trend log data reports are to use the room names stated above and they are to match the room names on the Architectural and HVAC drawing to be submitted with the package as part of the submittal prior to award. The trend log data reports are to include the following for each of the three rooms listed above taken in 5 minute (adjustable) intervals: Temperature (dB), (deg F), Relative Humidity (%), Refrigerator temp (deg F and deg C), Room Relative Pressure relationship. The graphical representation shall include a horizontal line (or two in the case of RH upper and lower limit) to indicate the design setpoints.

7. Exhaust System:

Vendor/Contractor shall provide all stainless steel (316L, welded seam, 18 gauge) ductwork to existing EF inlet located at ground level. Verify that the existing EF can meet the pressure drop requirements imposed by the system. The Vendor/Contractor shall have their HVAC design engineer come out to the facility to perform a site survey. Integrate the existing EF into the HVAC system. The existing EF is Greenheck, model number USF-08-3-B5-00-01-01, 800 CFM at 1.75 in. w.g. S.P.

Upon loss of airflow as detected by an air flow switch (sail switch), an audible alarm shall sound in the Pharmaceutical Unit (Trailer) and notify all trailer occupants to evacuate the mobile Pharmaceutical Unit (trailer) immediately evacuate the unit. Alarm for lack of airflow or EF fan operation shall be reported back to the vendor via an onboard control module. The vendor shall have a locally based technician out to our facility within 24 hours of such condition.

8. The HVAC system is to comply with NFPA 90a requirements when it comes to duct smoke detectors. The location of the duct smoke detectors shall be shown on the design drawings and should be tested in the presence of the COR and VAFD prior to acceptance of the Mobile Unit (Trailer). Connection to existing VAFD system with the front end located at the Fire House is the responsibility of this contractor.

9. Vendor/Contractor shall maintain a log of each service visit and submit it to the COR following every visit. Along with the log, the vendor shall submit a field service report summarizing the activities which took place on that day within 24 hours of the visit.

10. Where possible, the contractor is strongly encouraged to make use of digital scroll compressors or variable speed compressors in the HVAC unit.

11. Vendor shall have all sensors (temperature, relative humidity, combination temperature/relative humidity, room differential pressure sensors, etc.,) recalibrated annually and provide documentation to the VA demonstrating compliance with this requirement.

B. Electrical equipment will include single point connections for utility power (65kVA @ 208V, 3PH, 60Hz, 200A), and will necessitate the use of a fused disconnect switch at the power source, as well as the installation of a standard, rain-tight disconnect switch within sight of the mobile unit. The unit is to include a UPS so as to maintain continuous power to critical components such as the PC and save any data during interruption of power and before the emergency generator is up and running at full load.

C. Plumbing equipment will include the following: Instantaneous domestic HW heaters at each fixture. An insulated and heated gray water tank will also be on-board and will be either gravity drained or used for periodic dumping. All rooms within the mobile pharmacy will arrive completely plumbed, and thus ready for connection to domestic CW supply and drain lines. Vendor/Contractor shall include a maximum of 100 ft., ¾ in., type K, seamless, annealed, hard drawn piping domestic CW line. Along with that include 3” thick insulation and heat tracing back to the existing building 11 exterior wall penetration – approx. linear feet assumed to be 100. Alarms for the gray water level tank and a potential pipe freeze condition shall be reported back to the vendor via an onboard control module without delay. The Mobile Unit shall be equipped with an Eye Wash as required by USP800.

D. All biological safety cabinets in the USP 800 Buffer (HD compounding Room) shall be Class II or as required by USP800.

F. A Pharmacy-Grade refrigerator capable of maintaining the USP800 required temperature will be provided and placed in close proximity to an exhaust/return grille, and material airlocks to any adjoining spaces with 60 second HEPA purge and interlocking doors will be provided.

G. Prior to delivery to the site and mobilization, the contractor is to visit the site and conduct a site survey and develop a set of design drawings consisting of Architectural (including elevations and sections as necessary), HVAC, Plumbing, Fire Protection/Fire Alarm, IT/Communications at a minimum. The design documents are to be submitted to the VA for review and comments. Following a design review meeting, the final set of documents are to be submitted to the VA for our files.

H. The contractor shall be qualified and have the required levels of professional (PE license strongly preferred) and technical experience to perform the work (including design experience and qualifications for the HVAC and other trades) required by this statement of work.

I. All equipment, tools, etc., shall be properly maintained while contractors are on-site and shall be adequate, in quality and capacity, for proper execution of the work.

J. All OSHA applicable safety regulations shall be observed during all work of this contract.

K. All construction workers who will be on site during mobilization/site prep shall have at minimum a 10-hour OSHA Construction Certificate and one of them, designates as the “Competent Person” shall have a 30-hour OSHA Safety Training Construction Certificate.

L. Northport VAMC requires the Pharmaceutical Mobile Unit (Trailer) to be delivered, obtain CETA Certification and fully and completely operational no later than 5/12/22. The contract shall include two option years. The Options will be executed by the Government (one at a time) if deemed necessary.

M. All work in areas involved shall be coordinated with the VA Engineering Service representative.

N. All work shall be inspected during installation and at final completion jointly by the contractor and VA technical representatives.

O. The VA Safety Officer shall have the authority to see that the contractor follows all safety procedures and regulations relative to the fulfillment of this contract. Vendor/Contractor shall submit a Safety Plan.

P. At the completion of the contract, the Vendor/Contractor shall demobilize and disconnect all services back to the points of connection. The Vendor/Contractor shall completely remove all debris generated by the demobilization from the site.

Q. Vendor/Contractor will be asked to complete and submit a form (to be supplied by the COR) for ID badging of any employees who will be on site during the course of the contract.

R. All thermostats and humidistats shall have a digital display with the setpoint and actual temperature clearly indicated on the display.

S. Contract does not involve VA sensitive information/data.

T. National Archives and records and Records Administration (NARA) Records Management - attached

National Archives and Records Administration (NARA) Records Management

1. Contractor shall comply with all applicable records management laws and regulations, as well as National Archives and Records Administration (NARA) records policies, including but not limited to the Federal Records Act (44 U.S.C. chs. 21, 29, 31, 33), NARA regulations at 36 CFR Chapter XII Subchapter B, and those policies associated with the safeguarding of records covered by the Privacy Act of 1974 (5 U.S.C. 552a). These policies include the preservation of all records, regardless of form or characteristics, mode of transmission, or state of completion.

2. In accordance with 36 CFR 1222.32, all data created for Government use and delivered to, or falling under the legal control of, the Government are Federal records subject to the provisions of 44 U.S.C. chapters 21, 29, 31, and 33, the Freedom of Information Act (FOIA) (5 U.S.C. 552), as amended, and the Privacy Act of 1974 (5 U.S.C. 552a), as amended and must be managed and scheduled for disposition only as permitted by statute or regulation.

3. In accordance with 36 CFR 1222.32, Contractor shall maintain all records created for Government use or created in the course of performing the contract and/or delivered to, or under the legal control of the Government and must be managed in accordance with Federal law. Electronic records and associated metadata must be accompanied by sufficient technical documentation to permit understanding and use of the records and data.

4. The Department of Veterans Affairs Northport Medical Center and its contractors are responsible for preventing the alienation or unauthorized destruction of records, including all forms of mutilation. Records may not be removed from the legal custody of The Department of Veterans Affairs Northport Medical Center or destroyed except for in accordance with the provisions of the agency records schedules and with the written concurrence of the Head of the Contracting Activity. Willful and unlawful destruction, damage or alienation of Federal records is subject to the fines and penalties imposed by 18 U.S.C. 2701.

In the event of any unlawful or accidental removal, defacing, alteration, or destruction of records, Contractor must report to [FACILITY]. The agency must report promptly to NARA in accordance with 36 CFR 1230.

5. The Contractor shall immediately notify the appropriate Contracting Officer upon discovery of any inadvertent or unauthorized disclosures of information, data, documentary materials, records or equipment. Disclosure of non-public information is limited to authorized personnel with a need-to-know as described in the [contract vehicle]. The Contractor shall ensure that the appropriate personnel, administrative, technical, and physical safeguards are established to ensure the security and confidentiality of this information, data, documentary material, records and/or equipment is properly protected. The Contractor shall not remove material from Government facilities or systems, or facilities or systems operated or maintained on the Government’s behalf, without the express written permission of the Head of the Contracting Activity. When information, data, documentary material, records and/or equipment is no longer required, it shall be returned to The Department of Veterans Affairs Northport Medical Center control or the Contractor must hold it until otherwise directed. Items returned to the Government shall be hand carried, mailed, emailed, or securely electronically transmitted to the Contracting Officer or address prescribed in the [contract vehicle]. Destruction of records is EXPRESSLY PROHIBITED unless in accordance with Paragraph (4).

6. The Contractor is required to obtain the Contracting Officer's approval prior to engaging in any contractual relationship (sub-contractor) in support of this contract requiring the disclosure of information, documentary material and/or records generated under, or relating to, contracts. The Contractor (and any sub-contractor) is required to abide by Government and The Department of Veterans Affairs Northport Medical Center guidance for protecting sensitive, proprietary information, classified, and controlled unclassified information.

7. The Contractor shall only use Government IT equipment for purposes specifically tied to or authorized by the contract and in accordance with The Department of Veterans Affairs Northport Medical Center policy.

8. The Contractor shall not create or maintain any records containing any non-public The Department of Veterans Affairs Northport Medical Center information that are not specifically tied to or authorized by the contract.

9. The Contractor shall not retain, use, sell, or disseminate copies of any deliverable that contains information covered by the Privacy Act of 1974 or that which is generally protected from public disclosure by an exemption to the Freedom of Information Act.

10. The Department of Veterans Affairs Northport Medical Center owns the rights to all data and records produced as part of this contract. All deliverables under the contract are the property of the U.S. Government for which The Department of Veterans Affairs Northport Medical Center shall have unlimited rights to use, dispose of, or disclose such data contained therein as it determines to be in the public interest. Any Contractor rights in the data or deliverables must be identified as required by FAR 52.227-11 through FAR 52.227-20.

11. Training. All Contractor employees assigned to this contract who create, work with, or otherwise handle records are required to take VHA-provided records management training. The Contractor is responsible for confirming training has been completed according to agency policies, including initial training and any annual or refresher training.