Mobile Pharmacy Cleanroom IV Preparation Trailer, for preparing pharmaceutical compounded sterile preparations

Active

Contract Opportunity

1. Purpose: The Mobile Pharmacy Cleanroom will allow Department of Veterans

Affairs (VA) Pharmacy employees to prepare pharmaceutical compounded sterile

preparations (CSPs) that meet the standards of the United States Pharmacopoeia

(USP) Chapter797 (USP ) Pharmaceutical Compounding-Sterile

Preparations and Chapter (USP ). This request is for continuation of the

current service being provided while the Pharmacy is being renovated.

2. Scope of Work: The Contractor shall provide all labor, equipment, materials,

supervision, test equipment, repair/replacement parts, travel and transportation,

necessary for the initial installation and to provide emergency response to service calls and perform preventive maintenance, repairs and upgrades for the Lease of a USP 797/800 compliant

mobile IV preparation self-contained trailer.

3. Background: The sterile preparation of intravenous medications is vital

component of inpatient pharmacy services. The existing pharmacy is under

renovation. In the meantime, a mobile IV preparation trailer will be temporarily

installed to fulfill the requirements of the hospital.

4. Performance Period: This contract is effective from the effective for a Base Period of one (1) year and four (4) one-year renewal option periods.

5. Type of Contract: Firm-Fixed-Price.

6. Place of Performance: Kansas City VA Medical Center, 4801 East Linwood Boulevard, Kansas City, Missouri 64128

7. Hours of Operation: 24-Hour per Day, 7 Days per Week. Emergency Response shall be provided 24 hours a day, 7 days a week, and 365 days a year.

B. GENERAL REQUIREMENTS

1. Contractor Responsibilities: In addition to the other requirements contained herein

or in other areas of the solicitation and/or resultant contract, the contractor shall be

responsible for the following:

a. The contractor shall make an on-site visit prior to delivery to work with KCVA

engineering staff for any pre-delivery issues (power, plumbing, water waster, remote

monitoring, etc.) at no cost to KCVA. The contractor will also be responsible for

transporting the IV Preparation Trailer to the site location at the KCVA.

b. Exterior dimensions of the IV Preparation Trailer size shall be between 8’ and 12’ wide

and 50’ and 57’ long.

c. Trailer shall contain:

(1) A workroom for up to 2 workstations

(2) Non-hazardous anteroom

(3) Non-Hazardous IV preparation/buffer room

(4) Hazardous anteroom

(5) Hazardous IV preparation/buffer room

(6) Two laminar airflow hoods for non-hazardous compounding

(7) Two biological safety cabinets for hazardous compounding

(8) Two refrigerators

d. All out of warranty maintenance and service of the Trailer and Equipment to include all

preventative maintenance, service calls, transportation, parts, and labor provided via a

maintenance agreement with the KCVA.

e. All Preventative Maintenance, licensures, inspection, adjustments, calibrations, shall

be current with no lapses or pending discrepancies. Note: The VA reserves the right to

request copies of all documentation relating to the equipment. Evidence of performance

of recommended maintenance shall be provided by the contractor upon request from the

VA. All certifications required initially, and every six months will be provided by the

vendor.

f. Mobile IV Preparation Trailer and Equipment shall remain in place during the duration

of the contract.

g. IV Preparation Trailer shall maintain proper temperature, humidity and pressure to ensure maximum operation, calibration, and care of equipment and to ensure staff comfort and medication viability. Provide logs daily showing these ranges are being maintained.

h. HVAC System to maintain IV Preparation Trailer environmental systems.

1. Temperature range 60° to 66° Fahrenheit


2. Humidity 30% to 60%


3. Pressures:

Hazardous Drug Buffer Room -0.01 to-0.03

Non-Hazardous Drug Buffer Room. 0.02-0.05

Contractor will allow KCVA to install Temp Trak sensors inside the trailer which monitor temp, humidity and pressure inside the trailer. The sensors will be installed using an adhesive that can be removed at the end of the trailer use.

i. 24-Hour per Day, 7 Days per Week, telephone technical support (telephone technical

support shall be provided within 1 hour of the phone call being made).

j. On-site emergency repair service within 4 hours of notification24-Hour per Day, 7 Days per Week.

The contractors’ repair personnel should maintain constant communication with the COR

concerning the status of the repairs so that the COR can notify other medical personnel of potential

downtime affecting patient care. All repairs shall be conducted ASAP unless otherwise coordinated

with the COR. These services (to include all travel, labor, per diem, parts, and equipment) shall be provided via a maintenance agreement.

k. On-site non-emergency service within 24 hours of notification during normal business

operations (Monday through Friday, 8am-5pm). The contractors repair personnel

shall maintain constant communication with the COR concerning the status of the

repairs so that the COR can notify other medical personnel of potential downtime

affecting patient care. All repairs shall be conducted during normal business hours (8am

to 5pm) unless otherwise coordinated with the COR. These services (to include all

travel, labor, per diem, parts, and equipment) shall be provided via maintenance

agreement.

l. Fire alarm

(1) Provide connections to allow fire alarm to be connected to current KCVA fire system. The contractor is responsible for making the connections and testing the system per NFPA.

m. Water Connections

(1) Contractor will be responsible for making domestic water connections to the current water line that is on site at the trailer location.

(2) Contractor will be responsible for making connections to local sewer at current trailer locations.

n. Power requirement

(1) KCVA currently has emergency power 480 Volt 3PH 250 amp disconnect within 100 feet of the trailers location. The contractor shall provide cables and conduct to the trailer for all the services needed. Also provide a step-down transformer if needed to meet this requirement. Contractor will also need to supply/install new breaker and electrical wire from the disconnect to the main breaker panel inside the electrical room in the basement of valor building.

o. IV Preparation Trailer and Equipment Uptime (in-service) Rate of 98% during hours of operations.

p. Contractor will perform CETA certifications every 6 months and provide documentation.

q. Contractor will perform monthly terminal cleans to trailer.

r. Decommissioning trailer

(1) Contractor is responsible for uninstalling all utilities and putting site to the same condition before trailer was installed.

2. IV Preparation Trailer Capabilities/Requirements:

a. The IV Preparation trailer shall meet all USP 797/USP 800 requirements and must be

certified by an outside vendor, other than the manufacturer of the unit.

b. There shall be pass throughs equipped with a HEPA filtration air purge between the

workroom and the hazardous and non-hazardous buffer rooms.

c. Provided shelving, casework and work surfaces shall be 300 series stainless steel.

b. Pharmacy staff will deactivate, decontaminate, and clean all areas were hazardous

drugs are handled and disinfect all sterile compounding areas daily. The ceiling, interior

walls and floors of the interior spaces and the pass throughs may be affected. These surfaces shall

have minimal seams and crevices and be able to withstand appropriate

deactivation, decontamination, disinfecting and cleaning agents.

c. Plumbing

(1) A stainless-steel sink shall be available in each anteroom (2). Each station will

also include an emergency eyewash and emergency shower or drench hose

(2) The trailer shall have a utility tap to receive water from a provided source. This

tap shall receive water from a garden hose type connection.

(3) The trailer shall have a minimum 80 gallon on board freshwater tank

(4) The trailer shall have a minimum of 100 gallons on board the grey water tank that will

provide storage for batch dumping and will support gravity draining.

d. Electrical Specifications

(1) Single point connection

(2) Shore power inputs are prov

e. Data: The trailer shall be equipped with a patch panel with connections to the

workroom and buffer rooms.

f. Workroom Capabilities/Requirements

(1) Filtration: ISO Class 8

(2) Pressurization: Minimum 30 ACPH

(3) Minimum size/space

(4) Accommodate a minimum of 2 PC workstations/phone with min 2 (CAT5 min) data

jacks and 2 power receptacles

(5) Be centralized as to be able to access the anterooms for the hazardous and nonhazardous

anterooms and IV preparation rooms.

g. Non-Hazardous and Hazardous Anteroom Capabilities/Requirements

(1) Filtration: ISO Class 7

(2) Pressurization: Positive pressure with minimum 30 ACPH

(3) Minimum size/space: 4’ x 4’ x 7’ H (ceiling)

(4) Contain casework for personal protective equipment (PPE) that must be donned

by staff prior to entering the respective hazardous and non-hazardous IV preparation

rooms

(5) Contain a bench for staff to sit while donning/doffing PPE

h. Non-Hazardous IV Preparation/Buffer Room Capabilities/Requirements

(1) Filtration: ISO Class 7

(2) Pressurization: Positive pressure with minimum 30 ACPH

(3) Minimum size/space: 13’ x 8’ x 7’ H (ceiling)

(4) The room shall have 2 laminar or vertical flow hoods with a minimum workspace

dimension of 33” Wide x 22” Deep x 29” High for each cabinet. The hoods shall be

ISO Class 5 and be positive pressure.

(5) Refrigerator: minimum 20 cubic foot capacity

(6) Contain rolling shelving for working stock. Shelving shall have lockable casters

and have a minimum of 4 shelves.

i. Hazardous IV Preparation/Buffer Room Capabilities/Requirements

(1) Filtration: ISO Class 7

(2) Pressurization: Negative pressure with minimum 30 ACPH

(3) Minimum size/space: 13’ x 8’ x 7’ H (ceiling)

(4) The room shall have two Class 2 Biological Safety Cabinets with a minimum

workspace dimension of 33” Wide x 22” Deep x 29” High for each cabinet. The

hoods shall meet USP 800 requirements for the preparation of hazardous sterile IV

preparations. They should be ISO Class 5 and be under negative pressure.

(5) Refrigerator: minimum 20 cubic foot capacity

(6) Contain rolling shelving for working stock. Shelving shall have lockable casters

and have a minimum of 4 shelves.

j. KCVA will have an option to upgrade/replace hoods and software as new technology becomes available. Vendor will provide quotes to the VA at COR request.

3. Deliverables: Operations and Technical Support Manuals:

a. Performance Monitoring - The contractor shall comply with the following:

(1) Provide Service Reports to the Contracting Officer Representative upon request.

(2) The VA reserves the right to request copies of all documentation relating to the

equipment.

(3) Evidence of performance of recommended maintenance shall be provided by the

contractor upon request from the VA.

b. Security Requirements: CCTV with DVR capability to record 30 days of video to

provide perimeter/interior security. Any hard drives that may or may not contain Patient

Privacy Information (PII) remains the property of VA.

c. Risk Control

(1) IV Preparation Trailer and Equipment shall meet all Federal, State, and Local Fire

and Safety requirements.

(2) Safety and Warning Systems with Visual and Audible Alarms.

(3) Smoke Detectors and Fire Extinguishers.

(4) Emergency Lighting.

4. Delivery Schedule: Within 1 week of contractor awarded.

a. CHANGES TO STATEMENT OF WORK

Any changes to this SOW shall be authorized and approved only through written

correspondence from the CO. A copy of each change will be kept in a project folder

along with all other products of the project. Costs incurred by the contractor through the

actions of parties other than the CO shall be borne by the contractor.

b. GOVERNMENT RESPONSIBILITIES

1. Government shall determine and identify the location the trailers will be set up.

2. Government shall provide power connection, water source, and CAT VI data ports

adjacent to the parking space.

3. Government reserves the right to request copies of all documentation relating to the

equipment. Evidence of performance of recommended maintenance shall be provided

by the contractor upon request from the VA.

4. Government staff shall deactivate, decontaminate, and clean all areas

where hazardous drugs are handled and disinfect all sterile compounding areas daily.

5. Government shall conduct required and as needed inspections.

c. MONITORING PROCEDURES

The COR shall be responsible for monitoring the Contractor's performance. Performance

deficiencies or poor performance identified during the term of the contract shall be reported

to the Contractor. Upon notification of deficiencies or poor performance, the Contractor shall

be given 48 hours to take corrective action. If determined appropriate, the Contracting

Officer, COR and/or designated VA staff members shall meet with representatives of the

Contractor to review performance and resolve issues. All deficiencies or poor performance

will be documented and MUST be corrected within the timeframe specified by the

Contracting Officer. The Contractor shall send a written notice to the Contracting Officer and

the COR when correction(s) has been made.

E. INVOICES

1. Payment will be made upon receipt of a properly prepared detailed invoice, prepared

by the Contractor, validated by the Contracting Officers Representative (COR), and

submitted electronically through OB-10 (https://portal.tungsten-network.com/).

2. A properly prepared invoice will contain:

a) Invoice Number and Date

b) Contractors’ Name and Address

b) Accurate Purchase Order Number

c) Supply or Service provided

d) Total Amount Due

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