Cardiac Monitors
COMBINED SYNOPSIS SOLICITATION
(i) This is a combined synopsis/solicitation for BRAND NAME, CARDIAC MONITORS, as prepared in accordance with the format in Subpart 12.6, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; quotes are being requested and a written solicitation will not be issued. A firm-fixed price purchase order is anticipated.
(ii) The solicitation number is 36C24419Q0171 and is issued as a request for quotation (RFQ).
(iii) The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular 2005-95
(iv) This solicitation is set aside 100% for Service-Disabled Veteran-Owned Small Businesses and the associated NAICS 339112 code has a small business size standard of 1000.
(v) Contract Line Items (CLIN): ALL CLINS ARE BRAND NAME
B.2 PRICE/COST SCHEDULE
ITEM INFORMATION
ITEM NUMBER
DESCRIPTION OF SUPPLIES/SERVICES
QUANTITY
UNIT
UNIT PRICE
AMOUNT
0001
5.00
EA
__________________
__________________
Invasive Blood Pressure Module
LOCAL STOCK NUMBER: M1006B
0002
9.00
EA
__________________
__________________
IntelliVue Microstream Extension B06 Add dual IBP, Temp
LOCAL STOCK NUMBER: 867041
0003
3.00
EA
__________________
__________________
IntelliVue MX800 patient monitor A06 6-wave capability E08 FMS-8 with MMS mount H12 Intensive Care Software J13 RS232/MIB interface SC1 MSL system cable - 0.75 m EIL 030, CSN: 6515-568325, NXA-5YRPLAN-CRITICAL CARE-PHYSIO. MONITOR
LOCAL STOCK NUMBER: 865240
0004
10.00
EA
__________________
__________________
MX40 1.4 GHz Smart Hopping C01 Enhanced Arrhythmia S01 Continuous ECG
LOCAL STOCK NUMBER: 865350
0005
3.00
EA
__________________
__________________
Cardiac Output Parameter Module C10 PiCCO Continuous C.O. K03 CO Injectate Kit
LOCAL STOCK NUMBER: M1012A/862279
0006
1.00
EA
__________________
__________________
PIC iX Hardware H1U UPS Hardware HS1 PC Hardware with SSD
LOCAL STOCK NUMBER: 866424
0007
2.00
EA
__________________
__________________
M3176C Information Center USB Recorder
LOCAL STOCK NUMBER: 862120
0008
1.00
EA
__________________
__________________
24" Widescreen LCD Display - touch EIL 030, CSN: 6530-440022, NXA-5YRPLAN-CRITICAL CARE-MEDICAL MONITOR
LOCAL STOCK NUMBER: 866126
0009
1.00
EA
__________________
__________________
Installation Site Services
LOCAL STOCK NUMBER: H1028B/890500
GRAND TOTAL
__________________
B.3 DELIVERY SCHEDULE
ITEM NUMBER
QUANTITY
DELIVERY DATE
0001
SHIP TO:
VA MEDICAL CENTER
ATTN: RECEIVING
UNIVERSITY DRIVE C
PITTSBURGH, PA 15240
USA
5.00
12 DAYS ARO
MARK FOR:
JESTON ROBINSON
412-360-3718
JESTON.ROBINSON@VA.GOV
INSTRUCTIONS:
DELIVER ALL CLINS TO ADDRESS ABOVE
0002
9.00
0003
3.00
0004
10.00
0005
3.00
0006
1.00
0007
2.00
0008
1.00
0009
1.00
STATEMENT OF WORK - PRODUCT DESCRIPTION:
Cardiac Monitors
GENERAL INFORMATION
Scope of Work: The contractor shall provide all resources necessary to accomplish the deliverables described in this statement of work (SOW), except as may otherwise be specified. Procurement is for additional equipment and supplies which are needed to install new Philips cardiac and hemodynamic monitoring system (hereafter referred to as cardiac monitoring system or cardiac monitors) in the 3E-ICU at the VA Pittsburgh, University Drive Division Pittsburgh PA 15240.
Background: VA Pittsburgh purchased new Philips Cardiac monitors in FY17. Based on current bed needs, Critical Care Service Line would like to separate the 3E-ICU into two separate units and open four beds which were being used as simulation/storage to increase capacity. This requires additional cardiac monitoring equipment and supplies.
B. Cabling/Network
Turn-Key Installation providing all hardware and accessories for the Philips cardiac monitoring system, services shall include removal of current and older patient monitoring cabling/hardware.
This is a standalone network just for cardiac monitors
All cabling and accessories to provide a complete and functional system
All current network hardware: switches, routers, hubs, etc. must be replaced
Unit to unit connection charge shall include all cable runs, hubs, switches, routers and any other hardware or software required.
All above ceiling cabling runs shall be tie-wrapped and placed in telephone/data trough, in a conduit, or properly routed through interstitial area per hospital facilities requirements and local electric codes. This includes facility approval and post installation inspection when running cable through a fire barrier or fire wall.
Cables shall be bundled neatly, labeled, and in an orderly manner especially when cables converge with facility network hardware.
Cables shall be marked at each end indicating the termination point of the other end.
All new network cabling, terminations, and any patch panels used shall be CAT5E/CAT6 certified.
All cables shall be terminated TIA568B.
Any cable run through plenum space shall be plenum rated according to NEC and applicable fire codes.
All cable runs shall be tested and certified in accordance with TSB-67 and TIA/EIA 568-B or latest TIA/EIA Revisions.
The offeror shall provide a copy of all test results to the COR in electronic format that can be displayed and/or viewed.
Cable length shall be included in this report.
Documentation of the network shall also be provided and include a marked up drawing (as built) showing jacks and room locations.
The system will be configured to view patients throughout the hospital or care areas.
Drawings that indicate the location of the monitoring devices will be provided for the Medical Center.
Interface will be compliant with VA National interface standard.
Any offsite server or network maintenance or support provided by the offeror can only be done through VPN access after the offeror has obtained such access from the VA.
All networking hardware shall be rack mounted in room designated by Facility Project Manager or COR.
All installed monitors and hallway monitors will have supportive backing to improve weight distribution of the monitor and mounting arm.
All installed monitors will have power run through conduit.
Telemetry receivers will adhere to NFPA99 and NFPA101, especially relating to distance from sprinkler heads. Vendor may be required to install.
Offeror will adhere to ICRA Level 2 guidelines during installation.
Offeror agrees to mutually agreed upon timeframes for project completion and go-live.
Offeror will provide, or subcontract, mounting brackets to attach to existing GCX mounting arms.
Cabling and telemetry field will be needed.
Vendor to provide ICRA if applicable which is to be coordinated with biomedical engineering and COR.
C. HL7 Solution (If Applicable)
Offeror shall provide an HL7 interface solution allowing the exchange of data from point-of-care equipment through HL7 messaging to VISN 4 s Clinical Information System (CIS) / Anesthesia Record Keeper (ARK).
Included in the quote the offeror shall have a separate line item for 1 (one) year HL7 software support.
D. Installation and Implementation Services
The offerors shall provide coordinated professional installation and implementation project management services to implement the system specified in the scope of work at the Pittsburgh VA Healthcare System. Installation meetings and related activities shall begin within one week of contract award. This service shall include removal of existing system and turnkey installation. Offerors shall provide a firm estimate of working days required from date of purchase order to go-live based on scope of work.
The price quote shall include cost of installation which consists of assembling, positioning, and mounting of all equipment listed on the delivery order and connections of all cables. The hospital is responsible for furnishing all conduit and raceways unless specified otherwise on the delivery order. The equipment contractor is responsible for furnishing and pulling interconnecting wiring and cabling through conduit and raceways, and for making any connections. Interconnecting wiring and cabling which do not run through conduit and raceways shall be furnished and installed by the equipment contractor. It is the responsibility of the equipment contractor to install junction boxes, wall/ceiling mounts, and support structures supplied by the equipment contractor. The equipment contractor must provide well qualified field engineers or technicians to install and conduct all necessary tests which shall begin within (10) ten days after receipt of notice to proceed from the Contracting Officers Representative (COR) at the affected hospital.
Offeror will negotiate the work schedule with the COR assigned to the project. Compliance with this requirement shall be manifest by the continuous presence of the engineers or technicians on the job site during the daily working period. The contractor must provide the physical movement of the equipment from the storage point at final destination, to the area of installation, and the uncrating of the equipment. Vendor to provide ICRA if applicable which is to be coordinated with Biomed and COR
Rigging and special handling costs, if required, to move the equipment from dock area to the installation site within the consignee's premises, shall be borne by the equipment contractor.
Upon receipt of notice to proceed with installation, it shall be the contractor's responsibility to inform the Contracting Officer of any problems which may be anticipated in connection with installation or which will affect optimum performance once installation is completed. Such matters as inadequacy of power supply, limitations of site or inadequate preparation of site shall be reported prior to start of installation. Installation shall not proceed under such circumstances until authorized by the Contracting Officer.
In the event that progress of the installation is interrupted through no fault of the contractor, the continuous installation referenced in the preceding paragraphs may be terminated until such time as the cause of delay has been eliminated, and then shall be resumed within twenty-four (24) hours after the contractor has been notified that work may again proceed. Such termination of continuous installation shall be made only after two (2) hours notice has been given to the Contracting Officers Representative (COR) or person acting in that capacity at the hospital receiving installation. Contractor must notify the Contracting Officer within 48 hours of termination of installation.
Unless otherwise authorized by the Contracting officer, installation of equipment shall in no event exceed TWELVE (12) days from the date of notice to proceed with installation.60 days for the whole installation seems reasonable
Offers shall include new equipment and infrastructure for all care areas. Existing equipment will not be upgraded or utilized with the new system, with the exception of cabling/antennas.
E. IHE INTEGRATION STATEMENT
Vendor shall provide IHE (Integrating the Healthcare Enterprise) integration statement(s) (IIS) for proposed solution. (See http://www.ihe.net/ for more information)
F. MAINTENANCE REQUIREMENTS
Licensing Software updates: The offeror shall provide, at no charge for the life of the monitoring system, all computer software, access keys or codes, or external devices required for the operation, calibration, or repair of the equipment purchased. Any such items not listed on the price quote and required for maintenance of the system, shall be taken as included with the purchase of the system. Any upgrades or changes to the maintenance software, hardware, or access keys or codes shall be provided at no charge to the medical center during the time the equipment is operational at this facility. All application software licenses are included in the purchase of the equipment and shall not a require renewal charge for the period of time the equipment is in use in the facility.
INSTALLATION - The Contractor shall provide a system Installation Plan (IP) to the Contracting Officer Representative (COR) for approval prior to the start of work. The COR shall approve the IP and return the contractor. The Installation Plan shall include estimated timeline of start and completion and estimate unexpected delays/lead time.
Perform staging, programming, and configuration of all system infrastructures.
Perform all necessary test/audits on all system infrastructures.
TEST AND ACCEPTANCE: Contractor shall test all equipment after installation. The government shall accept equipment once installation and successful testing has been completed and approved.
WARRANTY/SERVICE CONTRACT: All equipment and materials shall come with a standard one year warranty. Warranty shall begin after installation of equipment and completion of tests.
G. CONTRACTOR RESPONSIBILITIES: The contractor shall be responsible for the following:
Contractor shall provide qualified personnel to perform install of the cardiac monitoring system expansion.
Contractor shall be responsible for all system/software testing after installation and prior to government acceptance.
Contractor is responsible for ensuring the proper disposal of all debris generated from installation activities.
Contractor is responsible for securing all materials, equipment and tools while on government property or in government facility. Government is not liable for any lost or stolen items that are not properly secured.
Vendor to provide ICRA class II if applicable which is to be coordinated with Biomed and COR
Provides active means to prevent air-borne dust from dispensing into atmosphere
Water mist work surfaces to control dust while cutting
Seal unused doors with duct tape
Block off and seal air vents
Wipe surfaces with disinfectant
Contain construction waste before transport in lightly covered containers
Wet mop and /or vacuum with HEPA filtered vacuum before leaving the area
Place duct mat at entrance and exit of work area
Remove or isolate HVAC system in areas where work is being performed.
H. GOVERNMENT RESPONSIBILITIES: The Government shall provide the following:
Provide site access and escorts through work areas as needed.
Provide primary electrical power.
Provide adequate space for the system equipment
I. OTHER CONSIDERATIONS:
CONTRACTING OFFICER REPRESENTATIVE (COR): The Contracting Officer Representative shall be the technical point of contact for all work related requirements. The COR does not have authorization to change, alter, or remove any requirements stated in the performance work statement. The Contracting Officer is the only government authorized person to change the performance work statement or any resultant contract.
PLACE OF PERFORMANCE: Installation shall occur at the Emergency Department (ED) and the Surgical Intensive Care Units (SICU) VA Pittsburgh, University Drive Division, Pittsburgh, Pennsylvania 15240.
WORK HOURS: Operational Hours are 0730-1600, Monday-Friday
DELIVERY: All deliveries shall be coordinate with the COR before arrival. Failure to coordinate delivery will be grounds to refuse delivery.
SECURITY REQUIREMENTS:
1. VA INFORMATION CUSTODIAL LANGUAGE
a. Information made available to the contractor or subcontractor by VA for the performance or administration of this contract or information developed by the contractor/subcontractor in performance or administration of the contract shall be used only for those purposes and shall not be used in any other way without the prior written agreement of the VA. This clause expressly limits the contractor/subcontractor's rights to use data as described in Rights in Data - General, FAR 52.227-14(d) (1).
2. INFORMATION SYSTEM HOSTING, OPERATION, MAINTENANCE, OR USE
a. Bio-Medical devices and other equipment or systems containing media (hard drives, optical disks, etc.) with VA sensitive information must not be returned to the vendor at the end of lease, for trade-in, or other purposes. The options are:
(1) Vendor must accept the system without the drive;
(2) VA s initial medical device purchase includes a spare drive which must be installed in place of the original drive at time of turn-in; or
(3) VA must reimburse the company for media at a reasonable open market replacement cost at time of purchase.
(4) Due to the highly specialized and sometimes proprietary hardware and software associated with medical equipment/systems, if it is not possible for the VA to retain the hard drive, then;
(a) The equipment vendor must have an existing BAA if the device being traded in has sensitive information stored on it and hard drive(s) from the system are being returned physically intact; and
(b) Any fixed hard drive on the device must be non-destructively sanitized to the greatest extent possible without negatively impacting system operation. Selective clearing down to patient data folder level is recommended using VA approved and validated overwriting technologies/methods/tools. Applicable media sanitization specifications need to be preapproved and described in the purchase order or contract.
(c) A statement needs to be signed by the Director (System Owner) that states that the drive could not be removed and that (a) and (b) controls above are in place and completed. The ISO needs to maintain the documentation.
3. SECURITY INCIDENT INVESTIGATION
a. The term security incident means an event that has, or could have, resulted in unauthorized access to, loss or damage to VA assets, or sensitive information, or an action that breaches VA security procedures. The contractor/subcontractor shall immediately notify the COTR and simultaneously, the designated ISO and Privacy Officer for the contract of any known or suspected security/privacy incidents, or any unauthorized disclosure of sensitive information, including that contained in system(s) to which the contractor/subcontractor has access.
4. LIQUIDATED DAMAGES FOR DATA BREACH
a. Consistent with the requirements of 38 U.S.C. B'5725, a contract may require access to sensitive personal information. If so, the contractor is liable to VA for liquidated damages in the event of a data breach or privacy incident involving any SPI the contractor/subcontractor processes or maintains under this contract.
b. Based on the determinations of the independent risk analysis, the contractor shall be responsible for paying to the VA liquidated damages in the amount of $37.50 per affected individual to cover the cost of providing credit protection services to affected individuals consisting of the following:
(1) Notification;
(2) One year of credit monitoring services consisting of automatic daily monitoring of at least 3 relevant credit bureau reports;
(3) Data breach analysis;
(4) Fraud resolution services, including writing dispute letters, initiating fraud alerts and credit freezes, to assist affected individuals to bring matters to resolution;
(5) One year of identity theft insurance with $20,000.00 coverage at $0 deductible; and
(6) Necessary legal expenses the subjects may incur to repair falsified or damaged credit records, histories, or financial affairs.
5. TRAINING
a. All contractor employees and subcontractor employees requiring access to VA
information and VA information systems shall complete the following before being granted access to VA information and its systems:
(1) Sign and acknowledge (either manually or electronically) understanding of and responsibilities for compliance with the Contractor Rules of Behavior, Appendix E relating to access to VA information and information systems;
(2) Successfully complete the VA Cyber Security Awareness and Rules of Behavior training and annually complete required security training;
(3) Successfully complete the appropriate VA privacy training and annually complete required privacy training; and
(4) Successfully complete any additional cyber security or privacy training, as required for VA personnel with equivalent information system access [to be defined by the VA program official and provided to the contracting officer for inclusion in the solicitation document e.g., any role-based information security training required in accordance with NIST Special Publication 800-16, Information Technology Security Training Requirements.]
b. The contractor shall provide to the contracting officer and/or the COTR a copy of the training certificates and certification of signing the Contractor Rules of Behavior for each applicable employee within 1 week of the initiation of the contract and annually thereafter, as required.
c. Failure to complete the mandatory annual training and sign the Rules of Behavior annually, within the timeframe required, is grounds for suspension or termination of all physical or electronic access privileges and removal from work on the contract until such time as the training and documents are complete.
6. MISC.
a. Before being granted access to VA information or information systems, all contractor employees and subcontractor employees requiring such access must sign the VA s Contractor Rules of Behavior.
b. Contractor must complete VA Privacy and Information Security Awareness and Rules of Behavior training prior to the performance of the contract and annually thereafter. Training must be completed in VA s TMS system (https://www.tms.va.gov/). Contractors must use the TMS Managed Self Enrollment method to complete the training in TMS. The COR must ensure that all contractors are validated in the PIH domain.
* The mitigating controls listed in OIS RBD 667 must be in place for the implementation of this system.
* Contractor owned computer equipment including laptops are not permitted to be connected to the VA network. They may only be used on the stand-alone network. They must be scanned for malware before connecting to the cardiac monitoring network. Contractor staff must be escorted at all times by authorized VA staff when performing work in sensitive IT areas such as data closets.
The Vendor is required to comply with physical security guidelines by either checking in with the VA Police each time they come on-site to perform contracted services or by obtaining a VA Contractor ID badge from the VA Police.
Contractor may not have access to any VA sensitive information or computer access under this contract. No vendor computer equipment can be connected to the VA Network at any time.
(viii) The provision at 52.212-1, Instructions to Offerors -- Commercial, applies to this acquisition and the following clauses AND instructions are added as addenda:
CLAUSES:
52.214-21 Descriptive Literature (APR 2002)
852-219-10 VA Notice of Total Service-Disabled Veteran-Owned Small Business Set-Aside
(a) Gray market items are Original Equipment Manufacturer s (OEM) goods sold through unauthorized channels in direct competition with authorized distributors. This procurement is for new OEM medical supplies, medical equipment and/or services contracts for maintenance of medical equipment (i.e. replacement parts) for VA Medical Centers.B No remanufactures or gray market items will be acceptable.
B
(b) Vendor shall be an OEM, authorized dealer, authorized distributor or authorized reseller for the proposed medical supplies, medical equipment and/or services contracts for maintenance of medical equipment (i.e. replacement parts), verified by an authorization letter or other documents from the OEM, such that the OEM s warranty and service are provided and maintained by the OEM.B All software licensing, warranty and service associated with the medical supplies, medical equipment and/or services contracts for maintenance of medical equipment shall be in accordance with the OEM terms and conditions.
(c) The delivery of gray market items to the VA in the fulfillment of an order/award constitutes a breach of contract.B Accordingly, the VA reserves the right enforce any of its contractual remedies. This includes termination of the contract or, solely at the VA s election, allowing the Vendor toB replace, at no cost to the Government, any remanufactured or gray market item(s) delivered to a VA medical facility upon discovery of such items.B
(ix) Evaluation of this requirement will be based on PRICE ONLY
(AUTHORIZED DISTRIUBTOR LETTERS FROM THE MFG MUST BE INCLUDED)
(x) Offerors are advised to include a completed copy of the provision at 52.212-3, Offeror Representations and Certifications -- Commercial Items, with its offer if has not been completed on SAM.gov.
(xi) The clause at 52.212-4, Contract Terms and Conditions -- Commercial Items, applies to this acquisition and the following clauses are added as addenda:
(End of Clause)
52.252-2 CLAUSES INCORPORATED BY REFERENCE (FEB 1998)
This contract incorporates one or more clauses by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. Also, the full text of a clause may be accessed electronically at this/these address(es):
http://farsite.hill.af.mil
https://acquisition.gov/far
(End of Clause)
852.203-70 Commercial Advertising (JAN 2008)
852.246-71 Inspection (Jan 2008)
(xii) The clause at 52.212-5, Contract Terms and Conditions Required To Implement Statutes Or Executive Orders -- Commercial Items, applies to this acquisition and the following additional FAR clauses cited in the clause are applicable to the acquisition:
52.204-10 Reporting Executive Compensation & First-Tier Subcontract Awards (OCT 2015)
52.209-6 Protecting the Government s Interest When Subcontracting with Contractors Debarred, Suspended, or Proposed for Debarment (OCT 2015)
52.219-28 Post Award Small Business Program Representation (JUL 2013)
52.222-19 Child Labor--Cooperation with Authorities and Remedies (FEB 2016) (E.O. 13126)
52.222-21 Prohibition of Segregated Facilities (APR 2015)
52.222-26 Equal Opportunity (APR 2015)
52.222-36 Equal Opportunity for Workers with Disabilities (JUL 2014)
52.222-50 Combating Trafficking in Persons (MAR 2015)
52.223-18 Encouraging Contractor Policies to Ban Text Messaging While Driving (AUG 2011)
52.225-3 Buy American--Free Trade Agreements--Israeli Trade Act (MAY 2014)
52.225-13 Restrictions on Certain Foreign Purchases (JUNE 2008)
52.232-34 Payment by Electronic Funds Transfer--Other than System for Award Management (JUL 2013)
(xiii) There are no additional contract requirements, terms or conditions.
(xiv) The Defense Priorities and Allocations System (DPAS) ratings are NOT APPLICABLE.
(xv) Quotes must be emailed to ronald.kline@va.gov and received no later than 12/20/2018 AT 12 NOON EST
Quotes may be submitted on this document (If you use this form, Include your company information name, address, phone number, POC, POC email, and DUNS #) or the vendor s own form.
If you are not the manufacturer then an AUTHORIZED DISTRIBUTOR LETTERS FROM THE MFG needs to be provided with your quote in order to be considered for the award.
NO LATE OFFERS WILL BE ACCEPTED
(xvi) For information regarding the solicitation, please contact Ronald Kline at ronald.kline@va.gov
Ronald.Kline@va.gov
Ronald.Kline@va.gov
