Attachment B_SOW Salient Characteristics Doc.docx

SECTION A

SOLICITATION/CONTRACT FORM CONTINUED

1. BPA Administration: All BPA administration matters shall be handled by the following individuals:

1. OFFEROR:

1. GOVERNMENT: Carlos Magana, Contracting Officer Carlos.Magana@va.gov

1. OFFEROR REMITTANCE ADDRESS: All payments by the Government to the Offeror will be made in accordance with:

[X] 52.232-34, Payment by Electronic Funds Transfer - Other than Central Offeror Registration, or

[ ] 52.232-36, Payment by Third Party

1. INVOICES: Invoices shall be submitted in arrears:

1. GOVERNMENT INVOICE ADDRESS: All invoices from the Offeror shall be submitted electronically to: www.fsc.va.gov/einvoice.asp.

1. ACKNOWLEDGMENT OF AMENDMENTS: The offeror acknowledges receipt of amendments to the Solicitation numbered and dated as follows:

s

The above amendment section must be filled-out in the event that an Amendment(s) is sent to the offeror or posted to www.ebuy.gov and must be returned with the RFQ package. Failure to acknowledge amendment(s) may constitute the rejection of the offer.

SECTION B

1. DESCRIPTION OF CONTRACT

1.1 This is a Blanket Purchase Agreement (BPA) contract for a USP 797/800 Mobile Pharmaceutical Trailer and related equipment with service maintenance pursuant to Federal Acquisition Regulation (FAR) parts 12, 13.5 and 16 for the Department of Veterans Affairs (VA), Veterans Integrated Service Network (VISN) 22. This BPA shall entail a USP 797/800 Mobile Pharmaceutical Lease with service maintenance agreements as listed in the schedule under Attachment A. Contractor agrees to the following terms of the BPA exclusively with the Long Beach Hospital Facility listed in 1.6. However, as requirements change, facilities within VISN 22 may be added or deleted by supplemental agreement between the Government and the Contractor.

1.2 This BPA does not obligate any funds. All products ordered under any delivery orders shall be subject to the terms and conditions of this BPA. The Government is obligated only to the extent of authorized delivery orders issued under the BPA by contracting officers for VISN 22.

1.3 VISN 22 has provided estimated requirements in Attachment A. Additional items may be added to this BPA that are related to the use of USP 797/800 Mobile Pharmaceutical Trailer and related services. All attachments identified in section D are hereby incorporated into this document as an attachment of the document itself, however this document shall supersede any conflicts of terms and conditions present in Section D.

1.4 The BPA base period shall be for a period of three years (3).

1.4.1 Base Period: (TBD upon award, target date of 3/1/2021 – 2/28/2024)

1.4.2 Period of Performance:

Option Year 2: 03/01/2023 -- 02/28/2024 Maintenance: 03/01/2023 – 02/28/2024

1.5 Delivery Orders issued shall be identified by BPA Number (To Be Determined upon award).

1.6 Participating Facilities: (Additional Facilities within VISN 22 may be added to this agreement with an exercise of a supplemental agreement between the CO and Contractor. A Contracting Officer Representative (Hereafter referenced as COR) shall be assigned from each facility as a primary point of contact. Overall pricing should reflect the overall volume of all sites below and should be taken into consideration for any addition of future facilities within VISN 22.

1.6.1 VA Long Beach Healthcare System | 5901 E. 7th Street, Long Beach, CA 90822 (LB)

2. SCHEDULE OF SUPPLIES AND SERVICES

2.1 Attachment A: This section shall comprise the BPA Schedule. Delivery Orders may be placed/obligated against items within the BPA Schedule. All items not specifically listed within Attachment A may still be provided under this BPA from the Contractor’s catalog at the following set discounted % of or shall provide a catalog with identified discounts on all items within the catalog. On annual basis, contractor shall provide an updated catalog of available items (An online catalog is acceptable).

(NOTE: SECTION 2 IS BEST ARTICULATED WITH ATTACHMENT “A” READILY ACCESSIBLE)

2.1.1 Tab 1 of Attachment A shall provide pricing for the following:

· Upon award, additional items may be added to this section via supplemental agreement between Contractor and the Government.

· Tab 1 shall provide information concerning Part Numbers, Nomenclature, Market Purchase Price, Discounted BPA Purchase Price, Monthly Lease Price, and Monthly Service Maintenance Price.

· Leases term lengths shall be for 36 months; however, each lease shall be created as a 12-month delivery order with two one-year options subject to the availability of funds.

· All leases are to be considered operating leases, not capital leases.

· Service Agreement pricing shall provide the following:

· Full repair coverage with no cap for all contracted equipment coverage at no extra charge and any associated diagnosis required to repair contracted equipment

· Prioritized repairs, typically with 24-48 hours turnaround

· Next day shipping in both directions included at no extra charge

· 24/7 technical support

· Repair tracking and history as well as reports of service usage

· Full access to preventative maintenance and educational courses

· Provision of loaner equipment at no extra charge during repair

· Only utilize OEM parts for any repairs by manufacturer certified technicians

· Provide all preventative maintenance as required by the provided equipment guidelines

· All repairs shall preserve the contracted equipment’s warranty

· All equipment, tools, etc, must be properly maintained while on the project and must be adequate, in quality and capacity, for proper execution of work.

· It is the contractors responsibility to ensure all personnel are qualified to conduct work in accordance with the statement of work.

· At the end of a 36-month lease, an extension may be provided upon supplemental agreement based upon pricing provided in column M of this tab. This pricing shall consider the amortization of the leased equipment and should result in a substantially reduced price from column N. This price should also be all inclusive of all taxes and fees. Service prices shall also be provided and not to exceed to 12 months after the end of the 36-month lease. Any additional extensions will require a supplemental agreement between Contractor and the Government. In the event a supplemental agreement is not reached timely, the contractor shall not charge any more than the amounts listed in columns M and N for a 12-month period after the end of a 36-month lease.

2.1.2 Other Pricing Considerations

· Items may be added to a 36-month lease for this USP 797/800 Pharmacy Trailer after commencement via supplemental agreement, but pricing shall be subject to the amortization of the equipment across the remaining term of the lease.

3. STATEMENT OF WORK

3.1 Introduction to Required Specifications

3.1.1 Purpose: The desired instrumentation shall have the capability of performing or reporting the clinical parameters as defined in the statement of work. The government requires a Pharmacy Sterile Compounding Trailer that meets current USP 797 and USP 800 specifications, as well as any additional specifications indicated below. The manufacturer must provide the certificate of compliance with USP 797 and USP 800 standards prior to use. The Pharmacy Sterile Compounding Trailer must also be in compliance with VHA Directives, VA HVAC Design Manual, VA Pharmacy Guidelines, applicable state and federal laws and guidelines.

3.1.2 Primary Goals: The Contractor is required to provide an USP 797/800 Mobile Pharmaceutical Trailer identified within individual delivery orders relating to Attachment A. Each option year awarded shall act as a lease for the Pharmaceutical Trailer. Each option year shall be subject to the terms and conditions of the BPA. Provided items shall be of the highest quality, sensitivity, specificity and tested to assure precision and accuracy. Alert/Notification of any delays in shipment as well as any or all technical advisory/recalls/alerts, prior to or simultaneously with field alerts should be forwarded to the designated individuals, Contracting Officer or designated VA Personnel and the VA Long Beach Medical program office. These individuals shall be identified upon award of the BPA.

3.1.3 Equipment: All equipment shall be new, state of the art, and not recertified nor refurbished. Equipment shall be acquired for the Long Beach Medical Facility: See section 1.6 and Attachment A.

· The layout of this pharmacy compounding trailer will include a mechanical space, a hazardous buffer room, a non-hazardous buffer room, an anteroom, and other critical components stated in the salient characteristic’s documentation. 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, certification, supervision and necessary transportation to provide a fully functional and compliant USP 797 and 800 mobile compounding pharmacy with hazardous drugs storage space.

3.1.4 Special Requirements: The vendor must make sure that the mobile unit complies with the utilities provisions and specs provided by the VA (view attachments). The vendor shall make sure that the mobile unit must comply with site preparation requirements provided by the VA. The VA will provide site preparation including the concrete pad surrounded by the fence and bollards and utilities provisions for the mobile unit.

· Contractor shall submit valid TB test results within 90 calendar days prior to start of work for all workers who will be working inside building 164.

· The vendor must ensure that the mobile unit will be able to connect to and use such utilities provisions per engineer plans.

· The vendor must make sure that the mobile unit is configured to the site prep drawings and specs provided by the VA.

· The contractor will be responsible for utility connections and provide service and corrective maintenance on all supplied equipment during the rental period (base year plus the additional option years).

· Moreover, as part of the site preparation provided by the VA, there will be a concrete pad surrounded by a fence and bollards to protect the trailer from vehicular traffic collision. The vendor is required to ensure that the mobile unit will fit within the fence on the concrete pad including the separate emergency exit staircase and the ADA accessible ramp and staircase for the mobile unit. In addition, the contractor is required to tie and secure the mobile unit to the anchored points on the concrete pad.

· Contractor must be responsible for testing/certifying the mobile unit prior to use by VA personnel

· The mobile unit provided must be able to function in harsh, ambient temperature conditions during the winter, and so shell insulation in its roof, walls and floors is strongly encouraged, preferably expanded foam type.

· Thermal glass should also be incorporated into windows, and well insulated doors should be installed.

· If the mobile unit is ready before the starting date indicated under Period of Performance listed above, the vendor will be responsible for storage of the trailer until that date, unless otherwise specified and agreed upon by the VA and contractor.

· Unless otherwise stated, all equipment shall be held to current industry standards for such equipment as present within the current market for a USP 797/800 Pharmacy Compounding Trailer.

3.2 Engineering Requirements

· Mechanical equipment will include variable capacity HVAC system; fan filter units to provide the required negative pressure interstitial space; and fan filter units for individual room temperatures as stated in the salient characteristics. Scopes shall offer several modes of zoom capability to enhance the size of images with minimal picture loss.

· Implemented HVAC system must allow for ductwork to be led upwards alongside a multistory building for rooftop exhaust.

· Electrical equipment will include single point connections for utility power as stated in the salient characteristics and Engineering plans.

· A gray water tank will also be on-board and will be either gravity drained or used for batch dumping.

· All rooms within the mobile pharmacy will arrive completely plumbed, and thus ready for connection to water supply and drain lines.

· Dedicated digital controls systems will be installed for each area in the trailer and will be used to maintain specific temperature and humidity set points per USP 797 and USP 800 requirements.

· Must be equipped with digital scroll compressors, or variable speed compressors in the unit’s air conditioning systems to assist in maintaining the required low temperatures and relative humidity ranges, as stated in the salient characteristics.

3.2.2 Services

· Contractor is responsible for Installation and set-up of the Pharmacy Sterile Compounding Trailer, including connections for electrical, water, sewer, cameras, key card system, and IT data.

· The data cables must be pulled through the utility pedestal conduit and connected to the appropriate switches in the IT closet in Building 164, Room 140, per Data Run Options attachment.

· Contractor must install security camera and badge reader data cables through the utility pedestal conduit and connected to the appropriate switches in the security closet in Building 164, Room 137.

· The contractor must perform on-site utility connections.

· Contractor must provide product support at no cost to the VA.

4. ANNUAL MAINTENANCE SERVICE STATEMENT OF WORK:

4.1 Full maintenance and repair services shall be required for a period of one (1) year after the Pharmacy Sterile Compounding Trailer is fully certified and in operation with two (2) additional option years.

· For emergency calls, contractor is required to respond on-site within 3 hours, and by the next business day for non-emergency calls.

· All repairs and maintenance services must be performed after hours or during weekends so that the impact to the Medical Center operations is minimized, unless emergency repairs are needed.

· All work must be certified VA point of contact (POC) as completed prior to invoicing.

· Monthly services:

· Must change HVAC pre-filters.

· Must exercise and test emergency generators in accordance with SCAQMD requirements and federal and state requirements.

· Refuel generators and fuel tank as necessary

· Contractor must add water treatment to grey water tank. Grey water tank must be emptied on regular basis or when it's 80% full.

· Quarterly services:

· Must lubricate direct drive motors on exhaust fans

· Must check pressure on all tires of the pharmacy trailer and add air as necessary.

· Semi-Annually services

· Must maintain CETA certification in compliance with USP 797/USP 800 and provide documentation to VA personnel.

· Must change HEPA filters in ceiling diffusers for both supply and exhaust and/or return

· Must Change filters in BSCs as needed.

· Change HEPA filters in pass-thru windows

· Airborne particle count for all three rooms (anteroom, non-HD buffer room, and HD buffer room)

4.2 Support Features

Installation/Site Preparation: Site preparation specifications shall be furnished in writing by the Contractor as a Site Preparation Report after award of the delivery/task order. The Contractor shall provide coordinated professional installation and implementation project management services to implement the system specified in the SOW. The Contractor must provide a firm estimate of working days required from date of delivery order to go-live based upon the SOW. The initial installation site report shall be provided to the VA Personnel, COR and CO no later than one week after the initial post award conference and all other site reports shall be provided at least forty-five (45) days before installation of all those sites. Contractor must visit the site and propose the location of equipment and determine specific site prep requirements including but not limited to:

4.2.1 Warranty: The Contractor shall provide a minimum warranty of no less than the length of the overall lease. Any lease extensions must include an inclusive warranty for all equipment.

4.2.2 User and Service Manuals: The Contractor shall provide to each station at no charge, two (2) complete and unabridged printed copies and one (1) electronic version (CD) of operator manuals, service manuals, electronic schematics, troubleshooting guides, diagnostic software and tools, and parts lists for each piece of equipment purchased to the POC with delivery of equipment upon request. Additionally, any upgrades to these documents shall be provided by the Contractor free of charge. These manuals shall include all components and subassemblies, including those not manufactured by the Contractor. These manuals and documentation shall be identical to the ones supplied to the manufacturer’s service representatives and shall contain the diagnostic codes, commands, and passwords utilized in maintenance, repair and calibration of the equipment and provided for the life of the system at no additional cost.

4.2.3 Training: The Contractor must provide a training program that is coordinated with and timely to the equipment installation. Training shall include initial setup and user training; onsite training for go-live support pertaining to the Mobile Pharmaceutical Trailer.

4.2.4 Service/Maintenance: Contractor shall provide a full service/maintenance program for The Pharmaceutical Trailer identified in Attachment A.

4.2.5 The vendor must perform on-site utility connections

· Complete repair of a covered item with Original Equipment Manufacturer (OEM) parts. Covered items will be shipped at the Contractor’s expense and no additional charge shall be made to the facility.

· Contractor is responsible for maintaining the installation and set-up of the Pharmacy Sterile Compounding Trailer, including connections for electrical, water, sewer, cameras, key card system, and data.

· Contractor must maintain and provide reports of repair usage of covered items upon facility request.

· Pricing for this program shall be included in Attachment A.

4.2.6 Upgrade/Updates: The Contractor shall provide updates to both the equipment hardware and software in order to maintain the integrity of the system and the state-of –the art technology, at no additional charge to the Government. These shall be provided as they become commercially available and at the same time as they are being provided to commercial customers. This requirement only applies to “system updates” that enhance the model of equipment being offered, i.e. new version of software, correction of hardware defect, update offered to commercial customers at no additional charge, upgrade to replace model of equipment no longer Contractor supported, etc. This does not refer to replacing the original piece of equipment provided under the BPA; however, it does refer to significant changes in the hardware operational capability. Should the VA Long Beach decide to upgrade their current equipment i.e. - replacement of existing equipment with newer models, the CO and Contractor may do so under a signed supplemental agreement.

5. PACKAGING & MARKING

5.1 Packaging

5.1.1 All equipment and supplies shall be adequately packaged to prevent damage during shipping, handling and storage. Bags or packages shall be whole, intact, and not otherwise torn or damaged. Upon delivery, the Government shall examine all packages. The Contractor shall be required to replace unacceptable or damaged products at the Contractor’s expense.

5.2 Marking

5.2.1 All items shall be marked clearly with the BPA Number, Delivery Order Number, Obligation number and delivery location within the hospital i.e. Emergency Room. For major Equipment, the Obligation number shall begin with an A after the station number i.e. 600A20000. All other service items shall be marked with a C number i.e. 600C20001. The Delivery Order number shall have a format similar to this example: 36C26221Q0249.

5.2.2 A list of all serialized equipment shall be provided with equipment delivery and also sent electronically to the contracting officer and specific using clinic.

6. DELIVERIES & PERFORMANCE

6.1 Installation/Implementation

6.1.1 The installation described in this BPA for an USP 797/800 Mobile Pharmaceutical Trailer must be completed no later than thirty (30) days after the award of the BPA. An extension may be allowed based on market conditions and reasonable lead times. Contractor must provide a USP 797/800 Mobile Pharmaceutical Trailer and be able to be installed with the current conditions in accordance with Attachment A and B. Contractor is responsible for delivery and installation of the Pharmaceutical Trailer. In addition, the contractor is responsible for properly removing the Pharmaceutical trailer from premises coordinating with VA personnel and returning site to its original configuration upon completion. To maximize a successful installation the following attachments have been provided to potential offerors to gain a further understanding of the requirement.

· Engineer plans are included to this requirement to present current conditions and technical information. Contractors must review to the Engineer plans to fully comprehend the requirement. Any changes or suggestions must be first be approved by VA Engineering personnel prior to that work being performed.

· All items must show a flow design in accordance with the Pharmacy Trailer Connections Design attachment and adhere to USP 797/800 guidelines.

· Contractors must run cables in accordance with the Data Run Options attachment to connect to the Main Telecom Room 189 (blue) and Electrical Room 137 (red). Upon award Engineering will coordinate with the contractor for running cables.

· Contractor must adhere to the IT-SOP 07-13 Cable installation Attachment, Labeling and testing guidelines when installing, but not limited to: cables, ports, faceplate walls, wall phone, panel, wall phone patch pane, and IT communications.

6.1.2 The timeline is based upon a reasonable attempt of the Contractor to complete all necessary installation/implementation requirements within the stated timeframe. Contractors shall not be penalized for implementation timelines that extend beyond the thirty (30) day timeframe, if the extension is through no fault of the Contractor and is a result of delays due to the Government (i.e. construction/remodeling of facilities). Upon award, the transition period for the awarded Contractor to have all equipment and peripherals installed and operational must be thirty (30) days from the date of award. During this same period all initial training of VA personnel in the operation and maintenance of said award shall also be completed with exceptions due to delays at the fault of the Government.

6.2 Acceptance and Performance: This paragraph establishes a standard of quality performance that shall be met before any equipment listed on the delivery order/BPA is accepted by the Government. This also includes replacement, substitute items and items that are added or field modified after a system has demonstrated successful performance. The acceptance period shall begin on the completion of installation and completed Certificate of Acceptance. A modification is required after lease commencement to reflect actual lease start and end dates if different from the delivery order due to delays in shipping or otherwise.

6.2.1 Certificate of Acceptance and Lease Commencement – The delivery order shall have a Lease Commencement Date of thirty (30) days from issuance unless otherwise accepted by the contractor. Lease will commence upon completion of a Certificate of Acceptance provided by the contractor to the VA Personnel and CO signifying that all equipment has been provided to the facility, training has been completed and equipment is primed for use. If all equipment is not received due to issues such as backorders, partial acceptance is allowable in order to commence the lease however invoicing shall be prorated both with service and equipment until all equipment is received.

6.2.2 During the term of the BPA, should the repair record of any individual piece of equipment reflect a downtime of 10% or greater of the normal working days in one calendar month, a determination shall be made by the designated representative of the Government to replace the malfunctioning equipment with new equipment at no charge to the VISN. Each instrument provided by the Contractor shall maintain an uptime of 90% in each month of the term of the agreement. Fault of failure attributable to Government misuse or handling shall void this requirement for each specific failure.

6.3 Delivery: The Contractor shall deliver all supplies and services identified in the schedule to the locations identified in section 1.6.

6.3.1 The delivery location is subject to change as required by the designated authority or authorized personnel at the receiving facility. The Contracting Officer Representative (Hereafter referenced as COR) shall be required to notify the Contractor when delivery locations have been changed.

6.3.2 All deliveries shall be made during normal working hours from 8:00 a.m. to 4:00 p.m. and a copy of the packing list/slip shall be provided at time of delivery. The packages packing list/slip shall contain the complete purchase order number, BPA number, shipping address, delivery location, items/quantity ordered, and items/quantity shipped. Standard orders shall be delivered within no more than 30 working days after receipt or placement of order.

6.4 Government’s Responsibility: The user will perform routine cleaning of instruments.

7. SALIENT CHARACTERISTICS

7.1 Rooms & Areas

· Unclassified area separating the main entrance from the anteroom.

· Anteroom

· Sterile Hazardous-Drug (HD) Buffer Room

· Sterile Non-Hazardous Drug (Non-HD) Buffer Room

· Sterile Hazardous Drug Storage Area

· Self-Supporting Modular Design inclusive of walls, roof ceiling, flooring, lighting, electrical & filtering equipment

· Modular clean room must fit in a 57’ L x 8’6” W x 13’6” H DOT approved semi-trailer Modular Clean

· Room seismic integrity provisions where necessary

· Finishes - Non-porous and cleanable surfaces, ceilings, walls, and floors with minimal seams and crevices, able to withstand appropriate deactivation, decontamination, disinfecting and cleaning agents.

7.2 Equipment Required

7.2.1 Unclassified Area

· Soiled PPE Waste Bin

· Stainless Steel Workstation

· One (1) data drop with 4 ports (RJ 45)

· Two (2) 120V power outlets with 2 sockets each

7.2.2 Anteroom

· Scrub sink with eyewash station and anti-scald device positioned at least 1 meter from the Sterile HD buffer room door

· Clean Personal Protective Equipment (PPE) Storage Bin

· Soiled PPE Waste Bin

· Staff Changing Bench

· Environmental Services Cabinet

· Two (2) ceiling mounted surveillance cameras: AXIS M3045-V Network Camera or equivalent

· 3M™ Avagard™ Hands Free Wall Dispenser (Government furnished; contractor installed)

7.2.3 Sterilize Hazardous Drug (HD) Buffer Room

· Two (2) ISO 5 Class II Type A2 Biological Safety Cabinets (BSC) spaced 1 meter apart from each other with 100% Outside Air Supply and Exhaust

· Interlocking HEPA filtered Pass-Thru Chamber from Anteroom

· Stainless Steel Workstation

· Thermo Scientific Refrigerator model TSX3005GA or equivalent

· Soiled PPE Waste Bin

· Storage Cabinet for compounded sterile hazardous drugs

· Mobile Solid stainless-steel shelving with lockable casters and a minimum of 4 shelves

· One (1) data drop with 4 ports (RJ 45)

· Three (3) 120V power outlets with two sockets each

· A wall mounted Clean Phone® or similar (GAI-Tronics 295-001W)

· Two (2) ceiling mounted surveillance cameras: AXIS M3045-V Network Camera or equivalent

· 3M™ Avagard™ Hands Free Wall Dispenser (Government furnished, contractor installed)

7.2.4 Sterile Non-Hazardous Drug (NON-HD) Buffer Room

· Two (2) ISO 5 Class II Type A2 Biological Safety Cabinets (BSC)

· Interlocking HEPA Filtered Pass-Thru Chamber from Anteroom or Unclassified Area

· Stainless Steel Workstation

· Thermo Scientific Refrigerator model TSX3005GA or equivalent

· Non-Hazardous Drug Storage Cabinet

· Mobile Solid stainless-steel shelving with lockable casters and a minimum of 4 shelves

· One (1) data drop with 4 ports (RJ 45)

· Three (3) 120V power outlets with two sockets each

· A wall mounted Clean Phone® or similar (GAI-Tronics 295-001W)

· Two (2) ceiling mounted surveillance cameras: AXIS M3045-V Network Camera or equivalent

· 3M™ Avagard™ Hands Free Wall Dispenser (Government furnished, contractor installed)

7.3 Environmental Controls

7.3.1 All facility & engineering controls compliant with USP 797/800 standards. Trailer must be able to maintain appropriate internal temperature, humidity and pressure requirements while located in Long Beach, CA, which has a Mediterranean-type, coastal climate. Temperature extremes may range from 20°F – 112°F with a relative humidity up to 100%.

7.3.2 The trailer must have fire alarm system that is completely independent and compliant with the NFPA requirement and has the capability to alert and automatically dial out when the fire alarm system is activated.

7.3.3 Physically separated Anteroom and Sterile Hazardous Drug Buffer Room and Sterile Non-Hazardous Drug Buffer Room.

7.3.4 C-PEC Containment Primary Engineering Controls:

· Two (2) ISO 5 Class II Type A2 Biological Safety Cabinets (BSC) in Sterile HD Buffer Room with

· 100% Outside Air Supply and Exhaust

· Two (2) ISO 5 Class II Type A2 Biological Safety Cabinets (BSC) in Sterile Non-Hazardous Buffer Room

7.3.5 C-SEC Containment Secondary Engineering Controls:

· ISO 7 Anteroom Environmental Controls:

· Positive pressure with greater than or equal to 0.02-inch Water Column

· Minimum of 35 Air Exchanges Per Hour (ACPH) compliant with USP 797 and USP 800 and VA HVAC Design Manual

· High Efficiency Particulate Air (HEPA) filtered supply air

· High Efficiency Particulate Air (HEPA) filtered exhaust air

· Room temperature shall be between 15 degrees Celsius and 20 degrees Celsius

· Humidity level shall be between 30% and 60%

· 24/7 Real-time Environmental Room Monitor providing: Room Temperature, Humidity, Differential Pressure (Positive pressure with greater than or equal to 0.02-inch Water Column)

· ISO 7 Sterile HD Buffer Room Environmental Controls:

· Negative pressure between 0.01-inch Water Column to 0.03-inch Water Column

· Minimum of 35 Air Exchanges Per Hour (ACPH) compliant with USP 797 and USP 800 and VA HVAC Design Manual

· 100% Outside Supply Air (into room)

· High Efficiency Particulate Air (HEPA) filtered supply air

· Zero recirculation of HD Buffer Room air

· Each compounding hood has a dedicated external exhaust that is HEPA-filtered directly to outside

· Buffer room has a dedicated and HEPA-filtered external exhaust that is 100% of air exhausted directly to outside

· Room temperature shall be between 15 degrees Celsius and 20 degrees Celsius

· Humidity level shall be between 30% and 60%

· 24/7 Real-time Monitoring Refrigerator interior temperature to ensure drug safety. The interior temperature for the refrigerator shall be between 2 degrees Celsius and 8 degrees Celsius.

· 24/7 Real-time Environmental Room Monitor providing:

· Room temperature

· Humidity

· Differential pressure (Negative pressure between 0.01-inch Water Column to 0.03-inch Water Column)

· ISO 7 Sterile Non-HD Buffer Room Environmental Controls:

· Positive pressure with greater than or equal to 0.02-inch Water Column

· Minimum of 35 Air Exchanges Per Hour (ACPH) compliant with USP 797 and USP 800 and VA HVAC Design Manual

· 100% Outside Supply Air (into room)

· High Efficiency Particulate Air (HEPA) filtered supply air

· Buffer room has High Efficiency Particulate Air (HEPA) filtered exhaust/return air

· Each compounding hood has built-in HEPA filter.

· Room temperature shall be between 15 degrees Celsius and 20 degrees Celsius

· Humidity level shall be between 30% and 60%

· 24/7 Real-time Monitoring of refrigerator interior temperature to ensure drug safety. The interior temperature for the refrigerator shall be between 2 degrees Celsius and 8 degrees Celsius.

· 24/7 Real-time Environmental Room Monitor providing:

· Room temperature

· Humidity

· Differential pressure (Positive pressure with greater than or equal to 0.02-inch Water Column)

7.3.6 Mechanical Room

· Back-up Emergency Generator(s) with Automatic Transfer Switch

· On-board freshwater tank and an on-demand electric water pump to provide running water for a sink and eyewash

· Gray water holding tank

· The pharmacy cleanroom will arrive completely plumbed, ready for use via holding tanks

· HVAC system to utilize R410A refrigerant

· All cameras, card readers and data ports will be prewired with 400 ft of CAT6a cable. Excess cable will be bundled and exit the trailer on the front-right side of the trailer closest to the utility pedestal as shown on the site-prep design.

7.3.7 Utility Requirements

· Mobile unit must comply with the drawings and specs of the site preparation provided by the VA. The mobile unit must be able to connect to the utility requirements and site preparation provided by the VA.

· Cables and conductors must be in conduits that are built for outside uses. All connections must be waterproof and tightly sealed.

7.3.8 Services: Contractor is responsible for Installation and set-up of the Pharmacy Sterile Compounding Trailer, including connections for electrical, water, sewer, cameras, key card system, and data.

· The data cables shall be pulled through the utility pedestal conduit and connected to the appropriate switches in the IT closet in Building 164, Room 140.

· The security camera and badge reader data cables shall be pulled through the utility pedestal conduit and connected to the appropriate switches in the security closet in Building 164, Room 137.

· Contractor must perform on -site connections.

7.4 Additional Requirements

7.4.1 CETA Certification is required prior to transferring Pharmaceutical Trailer to VA Long Beach.

7.4.2 Contractor must guarantee that product will meet and maintain USP 797 and USP 800 standards, and VHA Directives 1108.06 and 1108.12.

7.4.3 Installation of aluminum access ramp and emergency exit stairs. Access ramp to pharmacy sterile compounding trailer must have a configurable orientation to meet installation site needs and must have an alternative stairs pathway to the main entry door of the pharmacy sterile compounding trailer. One (1) set of emergency exit stairs shall be provided in case of emergency.

7.4.4 Four (4) security cameras (Model AXIS Q3515-LVE Network Camera or similar) to be mounted on the external walls of the trailer at each corner, all capable of viewing the main entrance to the trailer or the emergency exit.

· As mentioned above, cameras to be wired with 400 ft of CAT6a cable. Upon installation, contractor to pull wires through the conduit provided at the site prep to the security closet in building 164.

7.4.5 Trailer main entrance to be secured via Hirsch ScrambleSmartProx Reader. Reader to be wired with 400 ft CAT6a cable. Upon installation, contractor to pull wire through the conduit provided at the site prep to the security closet in building 164.

7.4.6 Contractor must be able to deliver and install pharmacy sterile compounding trailer within 6 months of awarding of contract.

7.4.7 The pharmacy sterile compounding trailer shall have back-up emergency power with Automatic Transfer Switch. The emergency generator(s) shall provide 100% coverage for the entire trailer and have the capacity to fully power the entire trailer for at least 72 continuous hours in case of normal power outage.

7.4.8 The trailer shall have fully functional, complete, and independent fire alarm compliant with NFPA 72 requirements respectively.

7.4.9 If required by South Coast Air Quality Management District (SCAQMD) and applicable federal, state and local regulations, obtain permit to construct and permit to operate from SCAQMD for emergency generators for the pharmacy sterile compounding trailer.

7.5 Definitions

· Air Exchanges Per Hour (ACPH)

· Biological Safety Cabinet (BSC): A ventilated cabinet for CSPs, personnel, product, and environmental protection having an open front with inward airflow for personnel protection, downward high-efficiency particulate air (HEPA)-filtered laminar airflow for product protection, and HEPA-filtered exhausted air for environmental protection.

· Compounding Aseptic Containment Isolator (CACI): A compounding aseptic isolator (CAI) designed to provide worker protection from exposure to undesirable levels of airborne drug throughout the compounding and material transfer processes and to provide an aseptic environment for compounding sterile preparations. Air exchange with the surrounding environment should not occur unless the air is first passed through a microbial retentive filter (HEPA minimum) system capable of containing airborne concentrations of the physical size and state of the drug being compounded. Where volatile hazardous drugs are prepared the exhaust air from the isolator should be appropriately removed by properly designed building ventilation.

· Compounded Sterile Preparations (CSPs)

· Containment Primary Engineering Control (C-PEC): A ventilated device designed to minimize worker and environmental HD exposure when directly handling HDs.

· Containment Secondary Engineering Controls (C-SEC): The room in which the C-PEC is placed.

· High Efficiency Particulate Air (HEPA)

· International Organization for Standardization (ISO) levels are cleanliness standards. There is also an air exchange minimum requirement as well as allowable particulate contaminate by size and per square meter.um concentration limits (particles/m3 of air)

· Personal Protective Equipment (PPE)

· Primary Engineering Control (PEC): A device or room that provides an ISO Class 5 environment for the exposure of critical sites when compounding CSPs. Such devices include, but may not be limited to, laminar airflow workbenches (LAFWs), biological safety cabinets (BSCs), compounding aseptic isolators (CAIs), and compounding aseptic containment isolators (CACIs).

· The United States Pharmocopeial Convention, Chapters 797 and 800 (USP 797/800)

· South Coast Air Quality Management District (SCAQMD)

8. CONTRACT ADMINISTRATION DATA

8.1 Ordering, Invoice and Payment

8.1.1 The Contractor shall list in the spaces below the name(s) and address(es) of customer service departments with whom the Government facilities shall place orders:

Name:

Address:

Phone No:

Fax No:

Contact:

Email:

Name:

Address:

Phone No:

Fax No:

Contact:

Email:

8.1.2 Payment Address: The Contractor shall submit in arrears a completed individual itemized invoice in accordance with the address below.

VA Finance Center PO Box 149971 Austin, TX 78714

8.1.3 Invoice Information: The following information shall be listed on all invoices (Failure to comply may result in refusal of an invoice resulting in delayed payment at the fault of the Contractor).

· Facility’s Name and address where service was provided

· BPA Number (For Example: VA262-BP-0001)

· Delivery Order Number (For Example: VA262-12-J-0001)

· Obligation Number (For Example: VA600-C27001)

· A Line Item break down of usage for example:

· Line item 1 URO Scope Lease: 1 MO at $400.00

· Line item 4 URO Service Maintenance: 1 MO at $10.00

· Identify the period of time by month/year charged in the invoice.

· BPA Holder’s Internal Contract number (if applicable)

· Include point of contact for concerns and questions. Contractor must name a specific person, phone number and email.

8.2 BPA Program Manager

8.2.1 The Contractor shall provide a BPA program manager who shall be responsible for the performance of the work under the BPA. In addition, the program manager shall act as the main focal point of communication between the Contracting Officer and the Contractor. The name of this person shall be designated in writing to the Contracting Officer. The program manager shall have full authority to act on behalf of the Contractor on all contractual/BPA matters relating to daily operation of the BPA.

Company Name:

Address:

Phone No:

Fax No:

Contact Name:

Email:

8.3 Hours of work

8.3.1 The BPA shall include five day a week, 9 hours a day full-service agreement to include all necessary service calls. After hours and weekends service are chargeable as per Supplies or Service and Prices/Costs section herein, Schedule of Labor Charges and Replacement Parts. Contractor may offer differing times for the service agreement but may not reduce the availability of time by no more than two hours from the above stated times.

8.3.2 Any service performed during other than normal work hours must be approved in advance by the facility, VA Representative, COR or CO.

8.3.3 Delivery of the trailer should be coordinated with the VA and occur at a time when traffic and congestion is lessened. Prefer weekend deliver.

8.3.4 Work shall be scheduled for proper execution to completion of this contract.

8.3.5 Holidays: Only emergency service shall be provided on National Holidays and only if authorized by the COR in advance as approved in the delegation of authority. The rates shall be chargeable as per Supplies or Service and Prices/Costs section herein, Schedule of Labor Charges and Replacement Parts.

8.3.6 When a National Holiday falls on a Sunday, the following Monday shall be observed as a National Holiday. When a National Holiday falls on a Saturday, the proceeding Friday is observed as a National Holiday by U.S. Government agencies. Also included, would be any other day, specifically declared by the President of the United States of America to be a National Holiday.

8.3.7 Safety Regulations:

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

· The VA Safety Officer shall have full authority to see that the contractor obeys all safety rules and regulations relative to the fulfillment of this contract.

· Vendor shall be responsible for providing the necessary barricades/signage where required.

8.3.8

9. SPECIAL BPA REQUIREMENTS

9.1 Physical Security and Facility Considerations

9.1.1 Identification, Parking, Smoking and VA Regulations (For any onsite services):

· The Contractor employees and/or Subcontractors approved by the VA personnel shall wear visible identification at all times while on the premises of the facilities within the VISN. Identification shall include but not be limited to a company identification card, which shall include the company name, employee name, title, and a photograph of the employee. Contractor Employees shall maintain a professional appearance commensurate to their industry.

· It is the responsibility of the Contractor to park in the appropriate designated parking areas. Information on parking is available from the VA Police Section. It will not invalidate or make reimbursement for parking violations of the Contractor under any conditions.

· Any interior or exterior doors that shall be unlocked to gain access shall be kept locked during the performance of work unless it results in the creation of a safety hazard. In those instances, the Contractor is responsible to take necessary actions to maintain the same level of security prior to gaining access/performing work. Should any other devices need to be unlocked like an entry gate, those devices shall be locked immediately upon entry or exit. At no time shall the Contractor allow any person into a locked area or loan keys/access cards to another person. Contractor may be held in default for failure to comply with this requirement and subject the Contractor and its employees to contractual and other legal remedies.

· Contractor personnel are required to check into the facility Police & Security office at each visit to pick up a “contractor” badge prior to contacting the COR. The Contractor’s staff shall also be required to sign in and out each day at a designated location determined by the COR.

· The Contractor agrees that none of its officers or employees shall use or reveal any research, statistical, medical, or security information which may be obtained during the performance of the work or as a result their presence on Government premises without the written consent of the Government

· Smoking is prohibited inside any buildings at facilities within VISN 22.

· Possession of weapons is prohibited. Enclosed containers, including tool kits, shall be subject to search. Violations of VA regulations may result in citation answerable in the United States (Federal) District Court, not a local district, state, or municipal court.

· The Contractor shall not allow his/her employees, including Subcontractors’ employees, to open desk drawers, cabinets, or to use office equipment, including the use of non-pay telephones for any purpose other than a local emergency call. The Contractor shall be responsible to provide all necessary equipment, tools, parts, and materials to perform the work. The Government shall not be obligated to provide any equipment, tools, parts, and materials to assist the Contractor in performing the work.

9.1.2 Background Checks:

· The Office of Security and Law Enforcement provides Department-wide policy on the assignment of appropriate position sensitivity designations associated with Department of Veterans Affairs (VA) positions involving national security and public trust responsibilities, and on the level of background investigations required for applicants for, and incumbents of, those positions.

· IAW VA 0710 Handbook, appointees and contract personnel appointed to Low/Moderate/High Risk positions must be subjects of a background investigation conducted by OPM and receive a favorable adjudication from the VA Office of Security and Law Enforcement to ensure compliance with such policy. If such investigation has not been completed prior to contract commencement, the Contractor shall be responsible for the actions of those individuals performing under the contract.

· Should the contract require Contractor’s personnel to maintain U.S. citizenship, the Contractor shall be responsible for compliance. Regardless of U.S. citizenship requirements, Contractor’s personnel are required to read, write, speak, and understand the English language, unless otherwise specified in this contract or agreed to by the Government.

· The cost for such investigations shall be borne by the Contractor, either in advance or as reimbursement to the Government. The level of sensitivity shall be determined by the Government on the basis of the type of access required. The level of sensitivity will determine the depth of the investigation and the cost thereof. At this time, the current estimated costs for such investigations are as follows:

LEVEL OF

SENSITIVITY

BACKGROUND

INVESTIGATION LEVEL

APPROXIMATE COST

· The Contractor shall be required to furnish all applicable employee information required to conduct the investigation, such as, but not limited to, the name, address, and social security number of the Contractor’s personnel. The VA will provide all the necessary instructions and guidance for submission of the documents required to conduct the background investigation. Background investigations shall not be required for contract personnel assigned to Low Risk/Non-sensitive positions for 180 days or less under a single contract or series of contracts. However, a Security Access Clearance (SAC) background screening will be required for appropriate preliminary checks IAW VA Directive 0710.

9.2 Information Technology Security Considerations

9.2.1 Prior to termination or completion of this Contract, Contractor/subcontractor must not destroy information received from VA, or gathered/created by the Contractor in the course of performing this Contract without prior written approval by the VA. Any data destruction done on behalf of VA by a Contractor/subcontractor must be done in accordance with National Archives and Records Administration (NARA) requirements as outlined in VA Directive 6300, Records and Information Management and its Handbook 6300.1 Records Management Procedures, applicable VA Records Control Schedules, and VA Handbook 6500.1, Electronic Media Sanitization. Self-certification by the Contractor that the data destruction requirements above have been met must be sent to the VA Contracting Officer within 30 days of termination of the Contract.

9.2.2 All electronic storage media used on non-VA leased or non-VA owned IT equipment that is used to store, process, or access VA information must be handled in adherence with VA Handbook 6500.1, Electronic Media Sanitization upon: (i) completion or termination of the Contract or (ii) disposal or return of the IT equipment by the Contractor/subcontractor or any person acting on behalf of the Contractor/subcontractor, whichever is earlier. Media (hard drives, optical disks, CDs, back-up tapes, etc.) used by the Contractors/subcontractors that contain VA information must be returned to the VA for sanitization or destruction or the Contractor/subcontractor must self-certify that the media has been disposed of per 6500.1 requirements.