65– RapidPoint Lab

Notice Type: Combine Solicitation

Posted Date: 28-AUG-18

Office Address: Department of Veterans Affairs;Columbus;Chalmers P. Wylie Ambulatory Care Center;420 North James Road;Columbus OH 43219-1834

Subject: 65-- RapidPoint Lab

Classification Code: 65 - Medical, dental & veterinary equipment & supplies

Solicitation Number: 36C25018Q9436

Contact: Kenyon E. Dulaney614-388-7827 mailto:[email protected] [Contract Specialist]

Setaside: Service-Disabled Veteran-Owned Small BusinessService-Disabled Veteran-Owned Small Business

Place of Performance (address): Chalmers P. Wylie VA Ambulatory Care Center;Columbus;420 N James Rd;Columbus, Ohio

Place of Performance (zipcode): 43219

Place of Performance Country: USA

Description: Department of Veterans Affairs

Columbus VAOPC

Department of Veterans Affairs Outpatient Clinic

This is a combined synopsis/solicitation for commercial items 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; proposals are being requested and a written solicitation will not be issued. The solicitation number is 36C25018Q9436 and is issued as a request for quotation (RFQ). The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular 2005-100. This is a Service Disabled Veteran Owned Small Business set-aside and the associated NAICS code is 334516 and small business size standard is 1000 employees. The requirement is for a Blood Gas Analyzer. This is a brand name or equal requirement. See below the statement of work for description and requirements. Delivery location is Chalmers P. Wylie VA Ambulatory Care Center, Columbus, Ohio 43219 and shall be FOB destination.

Statement of Work (SOW)

Currently Chalmers P. Wylie VA ACC uses Abbott iSTAT analyzers for Blood Gas testing. The current instruments are about 10 years old and due for an upgrade. The Abbott iSTAT are designed to work with PWEB database which is currently in the process of moving to UniPOC. This would incur a considerable costly data management system upgrade which the VA would be required to acquire to continue using instruments. In acquiring the RapidPoint 500 from Siemens the Chalmers P, Wylie VA would be supplied with new and updated instrument along with a data system upgrade at a more reasonable cost. The RapidPoint 500 offers a full test menu results from a single sample in approximately 60 seconds. It is an easy-to-use, maintenance-free cartridge-based system. Speed and flexibility to increase productivity without increasing staff workload.

Scope.

VAACC Columbus Pathology & Laboratory Medicine Service desires to acquire a point of care testing system for Blood Gas testing that is non-waived complexity with data management capability and connectivity compatible with VISTA. The acquisition will be a full equipment purchase along with purchase of consumables. Manufacturer will provide the appropriate number of test systems based on volume along with reagents for validation studies.

GENERAL REQUIREMENTS:

a. Offered Blood Gas RapidPoint 500 analyzer model shall be considered non-waived complexity by Clinical Laboratory Improvement Act (CLIA) approved for point of care testing and capable of producing accurate and reproducible assays on biological specimens by established in vitro diagnostic methods. The analyzers shall provide accurate results for sample specimens without excessive malfunctions, breakdowns, or service calls.

1. Offered testing equipment shall be new state-of-the-art equipment. Remanufactured and discontinued models will not be accepted.

2. The awarded contractor shall provide all upgrades to the equipment hardware and operating system software, at no additional cost to the Government during the lifetime of the instrument. These enhancements shall be delivered and installed at the Chalmers P. Wylie VA Ambulatory Center within 30 days of issuance to the commercial market.

3. The model being offered is in current production as of the date this offer is submitted. For purposes of this solicitation, "current production" shall mean that the clinical laboratory analyzer model is being manufactured as new equipment. Discontinued models that are only being made available as remanufactured equipment are not acceptable.

4. Contractor offered equipment shall perform satisfactorily at any laboratory temperature between and degrees Fahrenheit (15 and 30 Celsius) and relative humidity between 5 and 85 percent non-condensing and barometric pressure between 523 to 800 mmHg.

5. An operator s manual for each analyzer shall be supplied to the Chalmers P. Wylie VA Ambulatory Center.

b. Estimated yearly volume: 3,250 for Chalmers P. Wylie VA Ambulatory Center within the main facility. Estimated yearly quantities provided under this agreement are estimates based upon prior history of actual volumes and are not a guaranteed minimum.

c. Offerors shall provide pricing shall include all costs for:

1. equipment uses;

2. when additional equipment is needed throughout the contract,

3. all consumables, reagents, standards, controls and supplies

4. all necessary maintenance to keep equipment in manufacturer's operating conditions, both preventive maintenance, and emergency repairs

5. exchange program for malfunctioning units and guarantee of a replacement unit to be sent within 24 hours of notification

6. training for the all personnel operating the equipment

7. contractors are required to provide delivery, installation and removal of equipment at no additional charge

d. In the event that the consumables are found to be defective and unsuitable for use with the contractor's equipment, or the contractor has failed to comply with the requirements for routine supply delivery, the contractor shall deliver the consumable supplies within a period of twenty-four hours after receipt of the verbal order for priority delivery from the Government activity. If either circumstance has occurred, the contractor shall deliver to the requesting Chalmers P. Wylie VA Ambulatory Center facility site in the most expeditious manner possible, without additional cost to the Government, the necessary consumables in sufficient quantity as required to allow operation of the contractor's equipment for one week (under normal Government test load volume). If additional requests for emergency supply delivery are required by the Government, they will be honored by the contractor until the arrival at the Government site of the monthly standing order/routine supplies delivery. Failure to reserve adequate inventory may result in default.

Specific Tasks.

Provide instruments in working order, that have been validated, and according to type and quantity based on test volume.

Performance Monitoring

The RapidPoint 500 will have continuous quality control monitoring through internal and external checks that will be stored and analyzed by data management system with continuous oversight by lab personnel.

Security Requirements

Service & Maintenance will follow the security requirements as per VA s Medical Device Protection Program (MDPP) which protects VA s medical devices through a comprehensive security initiative that encompasses pre-procurement assessments, medical device isolation architecture (MDIA), communication, validation, scanning, access control list remediation, patching, and secure remote connectivity.

7.1 General Security

Contractors, contractor personnel, subcontractors, and subcontractor personnel shall be subject to the same Federal laws, regulations, standards, and VA Directives and Handbooks as VA and VA personnel regarding information and information system security.

7.2 Access to VA Information and VA Information Systems

a. A contractor/subcontractor shall request logical (technical) or physical access to VA information and VA information systems for their employees, subcontractors, and affiliates only to the extent necessary to perform the services specified in the contract, agreement, or task order.

b. All contractors, subcontractors, and third-party servicers and associates working with VA information are subject to the same investigative requirements as those of VA appointees or employees who have access to the same types of information. The level and process of background security investigations for contractors must be in accordance with VA Directive and Handbook 0710, Personnel Suitability and Security Program. The Office for Operations, Security, and Preparedness is responsible for these policies and procedures.

A BI is not required per VA Information and Information System Security/Privacy Requirements for IT Contracts dated August 2008 if the following exception applies:

Contract Personnel with limited and intermittent access to equipment connected to facility networks on which limited VA sensitive information may reside, including medical equipment contractors who install, maintain, and repair networked medical equipment such as CT scanners, EKG systems, ICU monitoring, etc. In this case, Veterans Health Administration facilities must have a duly executed VA Business Associate Agreement (BAA) in place with the vendor in accordance with VHA Handbook 1600.1, Business Associates, to assure compliance with the Health Insurance Portability and Accountability Act of 1996 (HIPAA) in addition to the contract. Contract personnel, if on site, should be escorted by VA IT Staff.

7.3 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.

7.4 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).

b. The contractor/subcontractor must store, transport, or transmit VA sensitive information in an encrypted form, using VA-approved encryption tools that are, at a minimum, FIPS 140-2 validated.

7.5 Information Systems Hosting, Operations, 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.

7.6 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.

b. To the extent known by the contractor/subcontractor, the contractor/subcontractor s notice to VA shall identify the information involved, the circumstances surrounding the incident (including to whom, how, when, and where the VA information or assets were placed at risk or compromised), and any other information that the contractor/subcontractor considers relevant.

7.7 LIQUIDATED DAMAGES FOR DATA BREACH

a. Consistent with the requirements of 38 U.S.C. --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. However, it is the policy of VA to forgo collection of liquidated damages in the event the contractor provides payment of actual damages in an amount determined to be adequate by the agency.

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.

REQUIREMENTS:

MFG: SIEMEN S (or Equal )

ITEM INFORMATION

ITEM NUMBERR

DESCRIPTION OF SUPPLIES/SERVICES

QUANTITY

UNITT

UNIT PRICE

AMOUNT

0001

1.00

EA

__________________

__________________

RAPIDPOINT 500

Contract Period: Base

POP Begin: 09-10-2018

POP End: 09-09-2019

LOCAL STOCK NUMBER: 10492730

0002

1.00

EA

__________________

__________________

UPS STANDARD 120V

Contract Period: Base

POP Begin: 09-10-2018

POP End: 09-09-2019

LOCAL STOCK NUMBER: 10324789

0003

1.00

EA

__________________

__________________

WARRANTY SERVICE RAPIDPOIN 500 PLUS QTY 1 START YR 1 NUMBER OF YEARS 2 INCLUDED EXTENDED SERVICE RAPIDPOINT 500 PLUS QUANTITY 1 START YEAR 3 NUMBER OF YEARS 3 INCLUDED

Contract Period: Base

POP Begin: 09-10-2018

POP End: 09-09-2019

0004

13.00

KT

__________________

__________________

RP405 MCART FULL+COOx 250 PART NUMBER 10283222 TOTAL KITS/ YR 13 COSTS/KIT 694.42 TEST / KIT 250 TOTAL TESTS/ YR 3250 COST/TEST 2.78

Contract Period: Base

POP Begin: 09-10-2018

POP End: 09-09-2019

0005

13.00

KT

__________________

__________________

AQC CTL

Contract Period: Base

POP Begin: 09-10-2018

POP End: 09-09-2019

LOCAL STOCK NUMBER: 10310323

0006

2.00

EA

__________________

__________________

CVM CTL

Contract Period: Base

POP Begin: 09-10-2018

POP End: 09-09-2019

LOCAL STOCK NUMBER: 10316535

0007

1.00

EA

__________________

__________________

HI FLOW AIR FILTER

Contract Period: Base

POP Begin: 09-10-2018

POP End: 09-09-2019

LOCAL STOCK NUMBER: 10322638

0008

1.00

EA

__________________

__________________

LUER CAPILLARY

Contract Period: Base

POP Begin: 09-10-2018

POP End: 09-09-2019

LOCAL STOCK NUMBER: 10309073

0009

5.00

EA

__________________

__________________

PAPER PRINTER THERMAL

Contract Period: Base

POP Begin: 09-10-2018

POP End: 09-09-2019

LOCAL STOCK NUMBER: 10315772

0010

1.00

EA

__________________

__________________

PROFIC SURVEY ADAPTOR KIT

Contract Period: Base

POP Begin: 09-10-2018

POP End: 09-09-2019

LOCAL STOCK NUMBER: 10492250

0011

1.00

EA

__________________

__________________

QUICK ADAPTER

Contract Period: Base

POP Begin: 09-10-2018

POP End: 09-09-2019

LOCAL STOCK NUMBER: 10329817

0012

2.00

EA

__________________

__________________

RAPIDQC 1 CTL

Contract Period: Base

POP Begin: 09-10-2018

POP End: 09-09-2019

LOCAL STOCK NUMBER: 10309925

0013

2.00

EA

__________________

__________________

RAPIDQC 2 CTL

Contract Period: Base

POP Begin: 09-10-2018

POP End: 09-09-2019

LOCAL STOCK NUMBER: 10309926

0014

2.00

EA

__________________

__________________

RAPIDQC 3 CTL

Contract Period: Base

POP Begin: 09-10-2018

POP End: 09-09-2019

LOCAL STOCK NUMBER: 10309927

0015

10.00

EA

__________________

__________________

WASH/WASTE CART 4PK

Contract Period: Base

POP Begin: 09-10-2018

POP End: 09-09-2019

LOCAL STOCK NUMBER: 10329097

0016

1 PKG

__________________

__________________

1)RP405 MCART FULL+COOx 250 PART NUMBER 10283222 TOTAL KITS/ YR 13 COSTS/KIT 694.42 TEST / KIT 250 TOTAL TESTS/ YR 3250 COST/TEST 2.78

2) AQC CTL

3) CVM CTL

4) HI FLOW AIR FILTER

5) LUER CAPILLARY

6) PAPER PRINTER THERMAL

7) PROFIC SURVEY ADAPTOR KIT

8) QUICK ADAPTER

9) RAPIDQC 1 CTL

10) RAPIDQC 2 CTL

11) RAPIDQC 3 CTL

12) WASH/WASTE CART 4PK

Contract Period: Option 1

POP Begin: 09-10-2019

POP End: 09-09-2020

0017

1 PKG

__________________

__________________

1) RP405 MCART FULL+COOx 250 PART NUMBER 10283222 TOTAL KITS/ YR 13 COSTS/KIT 694.42 TEST / KIT 250 TOTAL TESTS/ YR 3250 COST/TEST 2.78

2) AQC CTL

3) CVM CTL

4) HI FLOW AIR FILTER

5) LUER CAPILLARY

6) PAPER PRINTER THERMAL

7) PROFIC SURVEY ADAPTOR KIT

8) QUICK ADAPTER

9) RAPIDQC 1 CTL

10) RAPIDQC 2 CTL

11) RAPIDQC 3 CTL

12) WASH/WASTE CART 4PK

Contract Period: Option 2

POP Begin: 09-10-2020

POP End: 09-09-2021

0018

1 PKG

__________________

__________________

1) RP405 MCART FULL+COOx 250 PART NUMBER 10283222 TOTAL KITS/ YR 13 COSTS/KIT 694.42 TEST / KIT 250 TOTAL TESTS/ YR 3250 COST/TEST 2.78

2) AQC CTL

3) CVM CTL

4) HI FLOW AIR FILTER

5) LUER CAPILLARY

6) PAPER PRINTER THERMAL

7) PROFIC SURVEY ADAPTOR KIT

8) QUICK ADAPTER

9) RAPIDQC 1 CTL

10) RAPIDQC 2 CTL

11) RAPIDQC 3 CTL

12) WASH/WASTE CART 4PK

Contract Period: Option 3

POP Begin: 09-10-2021

POP End: 09-09-2022

0019

1 PKG

__________________

__________________

1) RP405 MCART FULL+COOx 250 PART NUMBER 10283222 TOTAL KITS/ YR 13 COSTS/KIT 694.42 TEST / KIT 250 TOTAL TESTS/ YR 3250 COST/TEST 2.78

2) AQC CTL

3) CVM CTL

4) HI FLOW AIR FILTER

5) LUER CAPILLARY

6) PAPER PRINTER THERMAL

7) PROFIC SURVEY ADAPTOR KIT

8) QUICK ADAPTER

9) RAPIDQC 1 CTL

10) RAPIDQC 2 CTL

11) RAPIDQC 3 CTL

12) WASH/WASTE CART 4PK

Contract Period: Option 4

POP Begin: 09-10-2022

POP End: 09-09-2023

GRAND TOTAL

__________________

SALIENT CHARACTERISTICS:

RAPIDPoint 500 Blood Gas Analyzer

The Chalmers P. Wylie VA ACC requires Blood Gas Analyzer that is easy-to-use, proven technology to advance our blood gas testing.

The following are the required characteristics:

Point-of-care blood gas analyzer

Ph, PCO2, Po2, Na+, K+, Ca++, CL- Testing

Multiple sample types: Heparinized whole blood, syringe and capillary

Small Sample Size

Quick turn-around-time

Small mobile footprint

Windows7 or greater

One Pathway Quality Control for multiple levels

Interfacing capability with 10BAE-T Ethernet and bar-code scanner

LIS and Dual-port transmission via Ethernet and serial port

Data Management System

Maintenance-free

NOTE: OFFERORS MUST PROVIDE DESCRIPTIVE LITERATURE, TO INCLUDE CURRENT WARRANTY PROVISIONS TO SUPPORT THE GOVERNMENT S EVALUATION OF THE OFFERED PRODUCT(S). (See Clause VAAR 852.211-73 Brand Name or Equal)

The Contractor shall delivery items FOB Destination (30 Days ARO):

Chalmers P. Wylie VA Ambulatory Care Center

420 N James Rd

Columbus, OH 43219-1834

This announcement constitutes the only solicitation; a formal, written solicitation will not be issued. PAPER COPIES OF THIS SOLICITATION WILL NOT BE AVAILABLE. This solicitation documents and incorporates provisions and clauses in effect through FAC 2005-100. It is the responsibility of the contractor to be familiar with the applicable clauses and provisions. The clauses may be accessed in full text at these addresses: https://www.acquisition.gov/Far/ The selected Offeror must comply with the following commercial item terms and conditions, which are incorporated herein by reference: FAR 52.212-1, Instructions to Offerors -Commercial Items, FAR 52.212-3, Offeror Representations and Certifications-Commercial Items - the selected offeror must submit a completed copy of the listed representations and certifications or confirm that the annual representations and certifications was completed electronically via the SAM website accessed through http://www.acquisition.gov; FAR 52.212-4, Contract Terms and Conditions-Commercial Items; FAR 52.212-5, Contract Terms and Conditions Required To Implement Statutes or Executive Orders-Commercial Items, paragraph (a) and the following clauses in paragraph (b): 52.204-10, 52.209-6, 52.219-28, 52.222-3, 52.222-19, 52.222-21, 52.222-26, 52.222-36, 52.222-50, 52.223-18, (ii) Alternate I 52.225-3, 52.225-13, 52.232-33. The full text of the referenced FAR clauses may be accessed electronically at https://www.acquisition.gov/far/.

The following VAAR Clauses apply

852.203-70 Commercial Advertising

852.211-70 Service Data Manuals

852.211-73 Brand Name or Equal

852.219-10 VA Notice of Total Service -Disabled Veteran-Owned Small Business Set-Aside

852.232-72 Electronic submission of payment requests

852.246-70 Guarantee (At least one-year)

852.246-71 Inspection

852.252-70 Solicitation Provisions or Clauses incorporated by reference

The following VAAR Provisions apply: N/A

Evaluation: will be made using the procedures under FAR 13. Offers will be evaluated Lowest price technically Acceptable. Offers should also include best expected delivery date

Set-Aside Requirement: Only verified SDVOSB and VOSB firms are eligible to submit an offer or receive an award of a VA contract that is set-aside for SDVOSBs or VOSBs in accordance with VAAR Part 819. A non-verified vendor that submits a bid or proposal should be rejected as non-responsive or technically unacceptable as listing in VIP is not self-correctable as a minor informality as, for example, a listing in SAM. All other purported SDVOSBs and VOSBs must apply for and receive verified status in accordance with 38 CFR Part 74 and be listed in VIP prior to submitting a bid or offer on an acquisition conducted in accordance with VAAR Part 819. The VIP database will be checked both upon receipt of an offer and prior to award.

New Equipment ONLY; NO remanufactured or "GRAY MARKET" items. All items must be covered by the manufacturer's warranty. No telephone requests for information will be accepted. Only emailed requests received directly from the Offeror are acceptable. It is the Offeror s responsibility to ensure the quote is received.

If an equal item is offered, the offeror must submit descriptive literature that conclusively establishes product equivalency and technical acceptability and compatibility at time of quote submission. IF THE OFFEROR IS NOT THE MANUFACTURER OF THE QUOTED ITEMS, THE OFFEROR SHALL SUBMIT WRITTEN EVIDENCE AT THE TIME OF QUOTE SUBMISSION THAT CLEARLY VERIFIES THEY ARE AN AUTHORIZED DISTRIBUTOR AND/OR RESELLER OF THE QUOTED PRODUCTS and will provide the items on or before the specified delivery date.

Quotes are to be emailed to Kenyon E. Dulaney at [email protected], no later than Tuesday, September 4, 2018 COB.

Link/URL: https://www.fbo.gov/spg/VA/CoVAOPC757/CoVAOPC757/36C25018Q9436/listing.html