United States - 66--Glucose Point of Care for VISN 2 South

Description

Added: Jun 10, 2019 11:13 am

This is a Sources Sought Notice only. This is not a Request for Quote. The purpose of this notice is to conduct market research and obtain information from qualified Contractors who are able to meet the requirements listed. This is not a solicitation. A solicitation will be issued at a later date. This notice does not restrict the Government to a particular acquisition approach. All information submitted in response to this announcement is voluntary. The Government will not pay for information requested nor will it compensate any Contractor for any cost incurred in developing information provided to the Government. The U.S. Department of Veterans Affairs, Network Contracting Office 2, and the VA Medical Centers in New York and New Jersey require a Point of Care Glucose Monitoring System. The Contractor shall provide approximately 240 Glucose Point-of Care glucose testing meters, reagents, standards, controls, supplies, parts accessories and any other item required for the proper operation of its contractor owned testing meters and peripherals if necessary for the generation of fingerstick cost per test (CPT) services. The glucose testing system MUST have FDA clearance for use on patients defined as critiacally ill and all other patients in each medical center.

Bronx VAMC

New Jersey VAMC

New York Harbor Healthcare System

Northport VAMC

Hudson Valley VAMC

Please See the list of requirements.

The NAICS Code is 334516 Analytical Laboratory Instrument Manufacturing

Interested Contractors are reminded that in accordance with FAR 4.12, prospective Contractors shall complete electronic annual representations and certifications in conjunction with FAR 4.11 required registration in the System for Award Management (SAM) database prior to award of a contract.

Your response needs to address how you will meet the Government's requirements. All Contractors that are

interested, regardless of their business type, and qualified to meet these requirements are asked to submit the

following information:

1) Company Name:

2) Company Address:

3) DUNS Number:

4) Company POC Name:

5) Company POC Phone Number:

6) Company POC Email Address:

7) Company Website:

8) Business type: (Large, Small, Woman-Owned, VOSB/SDVOSB, etc.):

9) You MUST be able to provide proof of FDA approval in critically ill patients and be able to confirm how and using what equipment. If you cannot provide proof of FDA approval you will be deemed non responsive at the time of your response to this sources sought.

Please identify your company's small business size standard and applicable NAICS code. For more information refer to http://www.sba.gov/content/table-small-business-size-standards.

Note: If claiming SDVOSB or VOSB, the firm must be registered and CVE verified in VetBiz Registry

http://www.vetbiz.gov/; also include VetBiz certification.

Please send your responses by email (no phone calls) no later than 3PM on Wednesday June 19, 2019 to Tina Cavalieri, Contract Specialist, at Tina.Cavalieri@va.gov, referencing the following 36C24219Q0796-Point-of care Glucose testing.

DO NOT SEND QUOTES AT THIS TIME

VISN 2 SOUTH

STATEMENT OF WORK

POINT OF CARE GLUCOSE TESTING

Scope

The Contractor shall provide approximately 240 glucose point-of-care glucose testing meters (glucometeres), reagents, standards, controls, supplies, parts, accessories and any other item required for the proper operation of its contractor owned testing meters and peripherals necessary for the generation of fingerstick glucose cost per test (CPT) services. The glucose testing system shall have FDA clearance for use on patients defined as critically ill and all other patients in each medical center, clinic and CBOC. The glucose testing system shall be defined by the 1988 Clinical Laboratory Improvement Act (CLIA) to ensure the broadest range of users throughout each Medical Center. VISN 2 SOUTH consists of the following Veterans Administration (VA) medical facilities: Bronx, Hudson Valley (Montrose and Castle Point), New Jersey (East Orange and Lyons), New York Harbor (Manhattan and Brooklyn), Northport, as well as their respective Community Based Outreach Clinics (CBOC).

Definitions

CBOC: Community Based Outreach Clinics

CPT: Cost Per Test

FS: Finger Stick, capillary method

POC: Point-of-Care

VA: Veterans Administration

WBG: Whole Blood Glucose

General Requirements

The methodology must be a rapid, reliable, and state of the art. Currently, Point-Of-Care (POC) Whole Blood Glucose (WBG) testing by capillary finger-stick method is performed on all in-patients and out-patients seen at participating CBOCS. The glucose testing system consists largely of POC glucose meters, computer (workstations and server) hardware and software platforms.

All of the VISN 2 South medical centers treat critically ill patients, defined as:

Mean arterial pressure of <60 or Systolic <90 mm Hg

On vasopressors

With hypothermia (Temperature < 95 F or 35 C)

With lactic acid over 4.0

With ejection fraction less than 15%

With mottling

Anaphylaxis

Patients with impaired peripheral circulation example include but not limited to patients with severe dehydration as a result of diabetic ketoacidosis, hyperosmolar non-ketotic syndrome, hypotension, shock, decompensated heart failure NYHA Class IV or peripheral arterial occlusive disease.

The glucose testing system shall have FDA clearance for use on patients defined as critically ill and all other patients in each medical center, clinic and CBOC. The glucose testing system shall be defined by the 1988 Clinical Laboratory Improvement Act (CLIA) to ensure the broadest range of users throughout each Medical Center.

Glucose Testing System (meter)

Glucose testing system (meter) shall provide accurate test assay result for sample specimens up to the manufacturer's defined maximum test per hour without excessive malfunctions, breakdowns, or service calls.

The glucose testing system (meter) shall be FDA approved for use on patient s meeting the definition of critically ill as define in the Scope above and all other patients in each medical center, clinic and CBOC.

The glucose meter shall be CLIA waived to ensure a broad range of users.

All models of glucose testing systems (meters) shall be capable of producing accurate and reproducible assays on capillary blood samples by finger-stick method utilizing established in vitro diagnostic methods. Sample size shall be within industry standards. The meter shall have the capability of utilizing both capillary and venous samples.

The application of sufficient sample, the strip must have the ability to detect an adequate sample, must be acknowledged by the meter.

Test time from application of sample to result must be within a reasonable and acceptable timeframe (seconds) and no longer than 60 seconds.

The meter shall be portable in a carrying case shall be supplied for each meter.

A meter with a rechargeable battery supply is preferred. Battery life shall be visible to the user on the operating screen.

The meter shall have lock out capability to prevent access by unauthorized and/or uncertified users.

The meter should have the option of user override to continue testing in case of emergency (i.e. HL-7 interface failure or any related downtime).

Contractors shall provide a minimum six-month supply of glucose testing strips with the same lot number sequestered for each site.

The glucose testing strip package and/or vials shall indicate the lot number, expiration date (unopened), expiration date (opened), and a bar code to facilitate the user in identifying the strip in use.

The user shall be locked out from use of the meter if quality control performance has exceeded 24 hours, one or both levels of quality control fail, and if calibration is past due and/or the strip lot number is unrecognized by the meter.

Contractor shall provide a written clear and concise, minimal and effective calibration procedure(s) and daily maintenance routine during implementation.

Performance

Meter shall have the capability to read a barcode (specifically those in use and produced by VA and within VISN 2 SOUTH) in order to accurately match the identification of the patient with the glucose result. For example, read an in-patient wrist band and an out-patient VA VIC (VA Identification Card) card.

The meter shall provide critical alerts to the user at both the low (hypoglycemic) and high (hyperglycemic) levels. The critical level shall be determined by each facility and the meter shall have the capability of a user alert when a critical level is resulted by the meter. This notification shall be designed to alert the user to take appropriate action for patient care.

The acceptable hematocrit range shall be 20% to 65% with no limitations over the full glucose measurement range (10 to 600 mg/dL).

The contractor shall provide six-point linearity materials twice annually included in the cost per test. Linearity will determine the Analytical Measurement Range (AMR) and shall be within the range stated by the contractor.

The linear range shall be from 10 mg/dL to 600 mg/dL.

The meter to meter validation shall meet the Correlation Coefficient (r ) of less than 1.0 during initial installation.

The meter to glucose analyzer validation shall meet Correlation Coefficient of less than 1.0 during initial installation.

Contractors shall provide an inter-laboratory Quality Assurance (QA) program for Quality Control.

Contractor shall state all medications and/or other substances that may interfere with the accuracy and specificity of the result obtained from their meter.

Service

The contractor shall provide customer support via telephone, available 24/7 for troubleshooting defective meters and defective docking stations.

When a defective meter cannot be repaired with customer support, a new meter shall be sent to the site within 5 working days.

The defective meter shall be returned to the contractor only if identifiable patient information can be deleted from the meter, as verified by the sites Information Security Officer (ISO). If this cannot be verified, the meter shall be turned over to the ISO for destruction.

The contractor shall provide customer support via telephone, available 24/7 for troubleshooting middleware failures. For example, failure to upload patient result, failure to recognize new lot number, failure to receive patient results in middleware, and others.

All replacements and customer support service shall be included in the cost per test.

All replacements of meters and docking stations shall be new and not refurbished.

Return shipping at the expense of the contractor shall be included in cost per test.

Data Management

Glucose results shall be viewed and printed (if necessary) in a VA compatible data management system. We require a data management system currently compatible with our current VistA laboratory information system.

The data management system shall provide a reliable interface in compliance with VA regulations and shall be provided by the contractor. The interface shall include any middle-ware and software required to send the glucose result to the patient s automated medical record in a timely manner.

The HL-7 interface shall be bi-directional.

Prior to upload, the operator should be able to scroll back to access a patient s result.

The middleware and/or operating system shall have capability of generating error logs and reports.

The meter shall have a docking station to allow the upload of the patient glucose result in less than 2 minutes.

If the system is wireless, the wireless data transmission, the instrument must be FIPS compliant.

Future Upgrade: Contractor shall provide all future system, or other technology upgrades at no additional charges to VISN 2 SOUTH. If the original instruments provided under the awarded contract become unsupported and/or obsolete, the contractor will provide instrument upgrades at no additional charges to VISN 2 SOUTH. The offer shall include the potential to include a wireless connection mirroring the original standard hard-wired connection. If the original instruments provided under the awarded contract are still supported or not obsolete but an upgraded instrument is developed, the Contractor will provide this new instrument upon request at the same discounted rate percentage as the original instrument.

The contractor shall provide all equipment including, but not limited to:

Meters

Docking Stations

All cables and connections

Computer hardware (servers and workstations).

Contractor shall provide a diagram of proposed hardware, its data flow and how their system operates)

Software and all software update for the life of the contract.

Connectivity

Data is downloaded from the POC glucose meter through docks and workstations installed throughout each facility in VISN 2 SOUTH and/or wireless interfaces to a VISN POC Glucose system central stand-alone server. A Health Level 7 ( HL7) interface must exist between the POC Glucose system that is bi-directional. This interface must be real-time for the transferring data to VistA and Computerized Patient Record System (CPRS) into the electronic VA patient record.

All computer workstations are physically connected to each other and to a file server with management capabilities by twisted-pair, coaxial, or fiber optic cables to form a local area network (LAN). MDIA VLAN (Medical Device Isolation Architecture Virtual Local Area Network) communication is governed by a managing protocol and a network operating system. The file server processes and stores data in a database, stores applications programs, and by running the network operating system program, allows multi-user data access. Since the file server supports the whole network, failure of an individual workstation does not disable the entire system. All of the data gathered at any workstation can be sent to the file server through the network. File servers have access to long-term data storage.

Middleware and/or Operating System

If the Glucose Testing System (meter) requires middleware and/or an operating system, the middleware and/or operating system shall be provided by the contractor and included

in the cost per test.

The maintenance and/or upgrade of the middleware and/or operating system shall be included in the cost per test for the life of the contract.

The license for middleware (if required) shall be included in the cost per test, and the annual renewal of the licenses, if required.

The middleware and or/operating system shall be compatible with the current HL-7 system in place at each site (VistA and CPRS).

The glucose testing system shall be validated and comply with all applicable FDA and UL (Underwriters Laboratories) regulations pertaining to medical devices and VA Medical Device Isolation Architecture.

The Contractor shall maintain the equipment in accordance with the Conformance Standards Section, by furnishing all necessary labor, management, equipment, tools, materials, repair service, tools, instruments, software and hardware updates and parts for service in accordance with the terms, conditions and schedule of this Statement of Work. The contractor shall provide repair service such as adjusting, replacing parts, and maintaining the equipment, including all intervening calls necessary between regular services and calibrations.

Infection Control

The meter shall be easy to clean, with readily available disinfectant wipes without leakage inside the meter. The contractor shall state the minimal cleaning requirements and the allowable disinfectant products for the meter. The contractor shall state if different cleaning procedures are required to disinfect for potential C. difficile or other bacteria.

Training

Contractors shall provide a user training plan detailing the level and extent of training offered.

We require a vendor supported training plan that includes in-dept training for the point-of-contact Ancillary testing Coordinator and the Nurse Educators.

We require a vendor supported training plan that includes user training to all three shifts and weekends, approximately 90% of all users identified at each site.

We require vendor support on go-live date, with sufficient representation at emergency department, intensive care units, and other areas where critical patient testing may be performed.

We require a detailed operating procedure manual in WORD format.

We require the inclusion of all test strips and supplies necessary for initial validation and all required regulatory validations (for example, linearity, meter to meter correlation, meter to analyzer correlation, precision, accuracy, etc.) in the cost per test.

We require the lot number of strips used for the initial validation to be the same lot number as the first six-month supplied.

Travel expenses incurred by the contractor to accomplish any part of installation shall be the responsibility of the contractor.

Opportunity closing date

19 June 2019

Value of contract

to be confirmed