36C26024Q0794_1.docx

THIS IS NOT A REQUEST FOR QUOTE:

THIS REQUEST FOR INFORMATION (RFI) IS ISSUED SOLELY FOR INFORMATION AND PLANNING PURPOSES ONLY AND DOES NOT CONSTITUTE A SOLICITATION. THE SUBMISSION OF PRICING, CAPABILITIES FOR PLANNING PURPOSES, AND OTHER MARKET INFORMATION IS HIGHLY ENCOURAGED AND ALLOWED UNDER THIS RFI IN ACCORDANCE WITH (IAW) FAR 15.201(e). DISCLAIMER This RFI is issued solely for information and planning purposes only and does not constitute a solicitation. All information received in response to this RFI that is marked as proprietary will be handled accordingly. IAW FAR 15.201(e), responses to this notice are not offers and cannot be accepted by the Government to form a binding contract. Responders are solely responsible for all expenses associated with responding to this RFI. SOURCES SOUGHT DESCRIPTION This is NOT a solicitation announcement. This is a sources sought synopsis only. The purpose of this synopsis is to gain knowledge of potential qualified sources and their size classification relative to NAICS 325413 (size standard of 1250 employees). Responses to this synopsis will be used by the Government to make appropriate acquisition decisions. After review of the responses to this sources sought synopsis, a solicitation announcement may be published. Responses to this sources sought synopsis are not considered adequate responses for a solicitation.

DISCLAIMER

This RFI is issued solely for information and planning purposes only and does not constitute a solicitation. All information received in response to this RFI that is marked as proprietary will be handled accordingly. In accordance with FAR 15.201(e), responses to this notice are not offers and cannot be accepted by the Government to form a binding contract. Responders are solely responsible for all expenses associated with responding to this RFI.

Point of Care Whole Blood Glucose Testing Background The VA Northwest Health Network, Veterans Integrated Service Network (VISN) 20, is responsible for providing health care to Veterans in the states of Alaska, Washington, Oregon, most of the state of Idaho, and one county in Montana. The VISN 20 sites listed under the Places of Performance require Point of Care Whole Blood Glucose monitoring for inpatient setting at the patient bedside and outpatient clinic locations.

Scope This BPA will provide VISN 20 with Point of Care Whole Blood Glucose Testing devices, interfaceable middleware (as applicable), supplies, reagents, and consumables required to properly perform required testing.

1.Description and Specifications

1.1. Specifications

1.1.1. The instruments shall have capability to perform testing as described below and meet the performance characteristics for accuracy and precision as defined by the 1988 Clinical Laboratory Improvement Act (CLIA) and the Clinical and Laboratory Standards Institute (CLSI).

1.1.2. If Contractor offers a family of analyzers, VISN technical evaluation panel will determine if instrumentation proposed meets needs of using facility.

1.1.3. Equipment shall be acquired for each of the clinical laboratories located at the VISN facilities listed in 1.5 Places of Performance.

1.1.4. The Contractor is required to provide a continuously stocked inventory of reagents, standards, controls, supplies, disposables, and any other materials required to properly perform tests on the equipment such that equipment operations are not interrupted. These items shall be of the highest quality, sensitivity, specificity and tested to assure precision and accuracy. Expiration date must be clearly marked on reagent, standards, and control containers. Unexpected changes in methodology shall be at the expense of the Contractor. Notification of any delays in shipment as well as any or all technical advisory, recalls and alerts, prior to or simultaneously with field alerts should be forwarded to the designated individuals determined at contract award. Estimated volumes of testing can be found in Price Cost Schedule.

1.1.5. Special handling for emergency orders of supplies: If the supplies 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 is required to deliver the supplies within 24 hours of receipt of a verbal order for emergency delivery. If either circumstance has occurred, the Contractor shall deliver to the Government 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 shall be honored by the Contractor until the arrival at the laboratory of the monthly standing order and routine supplies delivery.

1.2. Definitions

1.2.1. Cost per Test (CPT)- As defined in the Federal Supply Schedule FSC Group 66, Part III, Cost-Per-Test Clinical Laboratory Analyzers – Contractors are required to provide a price for each test that can be performed on its equipment. The per test price shall include costs covering (1) 5-year equipment use; (2) all reagents, standards, quality controls, supplies, consumable items, disposable items, parts, accessories and any other item required for the proper operation of the Contractor’s equipment and necessary for the generation and reporting of a test result: (3) all necessary maintenance to keep the equipment in good operating condition (This element includes both preventive maintenance and emergency repairs); and (4) training for Government personnel. Contractors are required to provide delivery, installation, and removal of equipment at no additional charge.

1.2.2. ISA -Technical details on how the interconnection is established or maintained are included within the Interconnection Security Agreement (ISA). A system interconnection is a direct connection between two or more information technology (IT) systems for the purpose of sharing data and other information resources. The VA uses the ISA to formally document the reasons, methodology, and approvals for interconnecting IT systems, to identify the basic components of an interconnection; to identify methods and levels of interconnectivity; and to discuss potential security risks associated with the interconnections.

1.2.3. Parameter definitions-

1.2.3.1. Point of Care Whole Blood Glucose – Blood glucose monitoring in inpatient setting at the patient bedside and at outpatient clinic locations.

1.3. General Requirements: CPT pricing will include reagents, service and maintenance of analyzers and data manager systems necessary to allow for release of a test result into the electronic medical record computer system. VISN20 is in the middle of converting to a new electronic medical record system. The vendor will need to be able to provide an interfaceable middleware for both VISTA and CERNER.

1.3.1. Technical Features – The instrumentation must be approved by the Food and Drug Administration (FDA) and shall have the following:

1.3.1.1. Ability to perform testing at locations that are remote from the laboratory. This may include hospital inpatient ward, hospital clinic, emergency department, operating room, or Community Based Outpatient Clinic locations.

1.3.1.2. Testing must be Waived Complexity by CLIA 88’ definitions

1.3.1.3. Strip Requirements:

1.3.1.3.1. Capillary and venous sample options.

1.3.1.3.2. No requirement for micropipette for application of blood for capillary test option.

1.3.1.3.3. Ability to detect poor reagent or strip integrity.

1.3.1.3.4. Interfering substances must be minimal. (Vendor should supply documentation detailing interfering substances).

1.3.1.3.5. Measurement range should span range of 10 – 600 mg/dl

1.3.1.3.6. Vendor should supply studies that show that data across an entire reportable range meets acceptance criteria of greater than or equal to 95% of individual values within ±12 mg/dL of the reference values at glucose concentrations below 100 mg/dl and within ±12.5% of the reference values of glucose concentrations at or above 100 mg/dL. (Reference: CLSI POCT 12-A3:2013 Point of Care Blood Glucose Testing in Acute or Chronic Care Facilities)

1.3.1.3.7. Testing strips should be stable until expiration date on container without adjustment of expiration date after opening.

1.3.1.3.8. Supplies (strips, controls, and linearity material) must have a shelf life sufficient to provide system stability for 12 months.

1.3.1.3.9. Quantities of a single lot number should be available to allow sites to maintain the same lot number per minimum shipment of one year of workload.

1.3.1.4. Instrument Requirements:

1.3.1.4.1. Downloader and rechargers must be provided if required as part of the testing system.

1.3.1.4.2. Sturdy design with ergonomic features to afford ease of use (singlehanded used by operators with various sized hands).

1.3.1.4.3. Scanning capability for patient armbands, controls, and test strips, operator ID barcodes with capability of manual entry as a backup system.

1.3.1.4.4. Ability to easily read on a horizontal surface.

1.3.1.4.5. Meter and software must be capable of displaying at least five user’s configurable comments for use with critical results.

1.3.1.4.6. Ability must exist to clear patient data from the meter prior to returning meter to the vendor for replacement.

1.3.1.4.7. Meter must be easy to disinfect and have a simple procedure to avoid contamination when testing patients. They should be able to withstand commercially available cleaning and disinfecting wipes. Vendor should provide documentation of cleaning procedure for the meter.

1.3.1.4.8. Meter must include a sturdy carrying case. Replacement carrying cases will be provided free of charge.

1.3.1.4.9. Maintenance must be simple and easily documented by the end user.

1.3.1.4.10. Replacement meters must be free of charge and readily available.

1.3.1.4.11. Rechargeable batteries should be included.

1.3.1.5. Data Manager Requirements:

1.3.1.5.1. Data Manager will be provided to monitor and evaluate test and quality control results.

1.3.1.5.2. Data Manager will assist with transmission of results to electronic medical record (using either Cerner or VISTA – specific to each site) for posting in patient records.

1.3.1.5.3. The Data Manager system should allow for tracking of competency assessment and notification of end users and supervisors when competency is expiring.

1.3.1.5.4. The Data Manager will allow coordinators to manage reagent lot numbers as applicable to the system.

1.3.1.5.5. The Data Manager System should have the ability to lock out users for any of the following scenarios:

1.3.1.5.5.1. Expired operator training and competency

1.3.1.5.5.2. Invalid operator

1.3.1.5.5.3. Failed quality control

1.3.1.5.5.4. Expired reagents

1.3.1.5.5.5. Invalid lot number of reagents

1.3.1.5.6. Capability must exist to add user configurable comments.

1.3.1.5.7. The Data Manager must have the ability to handle ADT feeds for positive patient identification.

1.3.1.5.8. Vendor must supply the following documentation for all analyzers and data management systems proposed to VISN 20:

1.3.1.5.8.1. MDS2 - Manufacturer Disclosure Statement for Medical Device Security.

1.3.1.5.8.2. VA Directive 6550 Appendix A- Pre-Procurement Assessment

1.3.1.5.8.3. FIPS-140-2 Certification for Wireless technology

1.3.1.5.8.4. MOU or ISA for Data Management systems that will require vendor access.

1.3.1.5.9. Vendor must have the ability to supply servers for all VISN 20. Costs for these servers and connectivity must be included in the quote.

1.3.1.5.10. The Data Manager must have the ability to handle data for other point of care analyzers. Vendor should supply a list of point of care analyzers that can be connected to the system.

1.3.1.5.11. Vendor must supply the servers that are required for the project.

1.3.1.6. Method Performance & Validation Requirements:

1.3.1.6.1. Method performance and comparison shall be at the expense of the Contractor, shall include linearity material and reagents, and be consistent with current CLSI guidelines and related documents, College of American Pathologists (CAP) standards and Federal regulations.

1.3.1.6.2. Correlation studies for each analyte. A minimum of 40 samples spanning the reportable range shall be run by the present and the proposed method. In systems where multiple sampling modes exist, mode to mode correlation studies must also be performed. Contractor shall provide technical support specialist to assist with studies and to analyze results and provide statistical data to support acceptance of the new method for above studies. Statistics shall consist of at least mean, bias, slope, y-intercept, correlation coefficient, and meet current standards defined by CLSI.

1.3.1.6.3. Analytical Measurement Range (AMR) Validation shall be performed on proposed instrument(s) for each analyte to validate the reportable range. The material must have values, which are near the low, mid, and high values of the AMR and be of appropriate matrix for the clinical specimens assayed by that method

1.3.1.6.4. Precision study using normal and abnormal control material. This shall consist of a within run precision study of 10 normal and 10 abnormal controls and a day-to-day precision study of normal controls and abnormal controls for 10 days (may be run twice a day) for a total of 20 values per level of control. Intra-VISN facility variations should be kept at an absolute minimum.

1.3.1.6.5. Sensitivity. Sensitivity may be validated concurrently with correlation studies. Mathematical calculations to determine efficiency, sensitivity, false positive rate, and false negative rate are applied.

1.3.1.6.6. Specificity Studies. A review of product literature and assay inserts to determine any adverse effects for increased bilirubin, hemolysis, lipemia, or other interfering substances.

1.3.1.6.7. Testing will not be implemented at the individual facilities for the selected system if the validation fails statistical studies as determined by the facility Pathology & Laboratory Service Chief.

1.3.1.7. Reference Range - A reference range must be determined for each test following CLSI guidelines. Samples used for the reference range study must be representative of the patient population being tested. Reference range assessment must be performed for each lab. One of the following protocols shall be used:

1.3.1.7.1. A verification of the manufacturer’s suggested reference range may be performed if the suggested range is based on a comparable population of test subjects. The manufacturer shall provide specific information defining how the suggested range was determined. A minimum of 20 reference individuals shall be used to verify the manufacturer’s range. Any apparent outliers should be discarded and new specimens obtained to provide a statistically valid verification.

1.3.1.7.2. If the suggested manufacturer’s range is not appropriate for the patient population, a reference range shall be established. Establishing a reference must follow CLSI guidelines. This requires a minimum of 120 reference individuals to be used to establish a reference range. The reference interval should be determined using the nonparametric method.

1.3.1.7.3. If a laboratory is currently using the proposed instrument and reagent system, the “in-use” reference range can be transferred to the “new” system if a method comparison study between the two systems prove to be acceptable. If comparison studies are not acceptable, one of the two above items must be performed.

1.3.2. Added Value:

1.3.2.1. The following would be of added value to the award:

1.3.2.1.1. The meters should have performance evaluation for use in critically ill patients.

1.3.2.1.1.1. This factor will be evaluated after the technical factors defined in the General Requirements section.

1.3.2.1.1.2. Vendor should supply documentation of performance evaluation for all FDA approved blood sample types. (i.e., venous, capillary, and arterial.)

1.3.3. Support Features-

1.3.3.1. The equipment models being offered shall be 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 offered as new equipment. Discontinued models that are only being made available as remanufactured equipment is not acceptable.

1.3.3.2. Start-Up Reagents. The Contractor shall provide all reagents, calibrators, controls, consumable items, disposable items, parts, accessories, and any other item included on the list of supplies defined in the Federal Supply Schedule contract and required to establish instruments for operation for performance of acceptance testing. The Contractor shall perform, to the satisfaction of the Government, all validation studies including precision, method comparison with current analyzer, accuracy (recovery), calibration verification, verification of reference interval, and determination of sensitivity and specificity at no cost to the Government. The Contractor shall perform all the statistical analysis as stated in the Method Performance and Validation section above and report data in an organized, clearly comprehensible format.

1.3.3.3. Training. The Contractor shall provide an instrument training program that is coordinated with and timely to the equipment installation, sufficient to the size and scope of the facility’s being supported. This shall include training on the operation of the system, maintenance, quality control, limitations of the test, data manipulation, and basic trouble shooting and repair, as applicable, to nursing, pharmacy, and laboratory personnel, to include Community Based Outpatient Clinic staff at their work locations.

1.3.3.4. Equipment Maintenance and Repair Service. The Contractor shall be able to provide replacements on all instrumentation and any incremental support equipment, e.g., charging bases, and rechargeable batteries, offered according to the following terms:

1.3.3.4.1. Service Requirements

1.3.3.4.2. A technical assistance center shall be available by telephone 24 hours per day, 7 days per week with maximum call back response time of 1 hour.

1.3.3.4.3. The contractor shall provide the necessary information to replace an inoperable device.

1.3.3.4.4. This replacement shall include meters, charging bases, and rechargeable batteries at no additional cost.

1.3.3.4.5. A minimum acceptable service shall also include replacement delivery of items to be replaced with overnight service, but no longer than one (1) business day from the time-of-service ticket confirmation.

1.3.3.5. Upgrades - The Contractor shall provide upgrades to the equipment hardware 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 upgrades” that enhance the model of equipment being offered, i.e., new version of software, correction of hardware defect, upgrade 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 contract: however, it does refer to significant changes in the hardware operational capability.

1.3.3.6. Ancillary support equipment - The Contractor shall provide, install, and maintain through the life of the contract, as indicated, all ancillary support equipment to fully operate the analyzer as defined in these specifications, e.g., rechargeable batteries. In addition, the Contractor shall include all ancillary components that are customarily sold or provided with the model of equipment proposed, e.g., starter kits, etc.

1.4. Characterization of waste

1.4.1. The Contractor shall provide documentation that it has characterized the hazardous nature of all wastes produced by all equipment, devices, reagents, and discharges in accordance with the requirements of the Code of Federal Regulations Title 40 “Protection of the Environment” Part 261 et seq. and applicable state and local requirements. Documentation shall include a description of the characteristics of the hazardous waste produced as a byproduct of the instrument operations, Safety Data Sheets (SDS) meeting the requirements of the Occupational Safety and Health Administration (OSHA) and Environmental Protection Agency (EPA), the analytical process used to determine the hazardous nature and characteristics of the waste, and the analytical test results. Testing of hazardous waste is to be done in accordance with testing protocol specified for each individual waste as described in the Code of Federal Regulations Title 40 to decide if the waste is hazardous waste or otherwise regulated.

1.4.2 The determination and description shall address the following:

1.4.2.1. Waste toxicity (Reference 40 CFR §261.11 and 40 CFR §261.24)

1.4.2.2. Waste ignitability (Reference 40 CFR §261.21)

1.4.2.3. Waste corrosivity (Reference 40 CFR §261.22)

1.4.2.4. Waste reactivity (Reference 40 CFR §261.23)

1.4.2.5. Hazardous waste from non-specific sources (F-listed) (Reference 40 CFR §261.31)

1.4.2.6. Discarded commercial products (acutely toxic or P-listed and toxic or U-listed) (Reference 40 CFR §261.33)

1.4.2.7. Solid Waste (Reference 40 CFR §261.2)

1.4.2.8. Exclusions (Reference 40 CFR §261.4)

1.4.3. The contractor will provide written instructions and training material to ensure VHA laboratory staff are trained as needed to properly operate devices with special emphasis to managing and disposing of hazardous waste in accordance with EPA and state requirements. Additionally, the training provided by the contractor must fulfill Resource Conservation and Recovery Act (RCRA) requirements for training as applicable to devices.

1.4.4. Contractor shall provide a description of all wastes the process or equipment may discharge so that the facility can determine whether the discharge meets Local Publicly Owned Treatment Works (POTW), State and Federal discharge requirements. At a minimum, the characteristics of ignitability, corrosivity, reactivity and toxicity as defined in 40 CFR §261 must be determined and documented. Any mercury containing reagents must be identified in any concentrations. All test results shall be provided. All listed chemicals (F, U, K and P) found in 40 CFR §261 shall be provided in product information and their concentrations documented. For those materials with a positive hazardous waste determination, a mechanism for the laboratory to meet local discharge requirements (i.e. mercury, thimerosal and formaldehyde) must be developed and SDS sheets must be provided in advance for review. At a minimum, documentation shall include, but not be limited to the concentration and measures of the elements and parameters listed below and must be included with vendor response:

· Barium (Total)

· Cadmium (Total)

· Chromium (Total)

· Copper (Total)

· Cyanide (Total)

· Lead (Total)

· Mercury (Total)

· Nickel (Total)

· Silver (Total)

· Zinc (Total)

· Arsenic (Total)

· Selenium (Total)

· Tin (Total)

· pH

· Flash point (to higher than 200°F)

· BOD; biochemical oxygen demand

1.4.5. The documentation the contractor provides will be used to work with the Medical Center and the public to determine whether the waste from each device can legally be disposed of via the sewerage system.

1.5 Places of Performance

· Alaska VA Healthcare System

· Colonel Mary Louise Rasmuson Campus 1201 North Muldoon Road Anchorage, AK 99504

· Fairbanks CBOC 2555 Phillips Field Road Fairbanks, AK 99709-3933

· Soldotna CBOC 237 West Rockwell Avenue Soldotna, AK 99669-7412

· Matanuska-Susitna (MAT-SU) CBOC 865 N. Seward Meridian Parkway Wasilla, AK 99654-7241

· Juneau CBOC 709 West 9th Street, Federal Building, Suite 150 Juneau, AK 99801-1807

· Alaska Domiciliary Care for Homeless Veterans 3001 C. Street Anchorage, AK 99503

· Boise VA Medical Center

· Boise VA Medical Center 500 West Fort Street Boise, ID 83702

· Eastern Oregon VA Clinic 635 Highway 20 North Hines, OR 97738

· Mountain Home CBOC 815 North 6th Street East Mountain Home, ID 83647

· Caldwell CBOC 713 Haystack Way Caldwell, ID 83605

· Twin Falls VA Clinic 260 2nd Ave. East Twin Falls, ID 83301

· Salmon CBOC 705 Lena St.Salmon, ID 83467

· Portland VA Health Care System

· Portland VA Medical Center 3710 SW US Veterans Hospital Rd Portland, OR 97239

· Vancouver VA Medical Center 1601 East 4th Plain Blvd. Vancouver, WA 98661

· Portland VA Clinic 308 Southwest 1st Ave, Community Resource & Referral Center (CRRC), Lawrence Bldg., Suite 155 Portland, OR 97204

· Fairview VA Clinic 1800 Northeast Market Drive Fairview, OR 97024

· Hillsboro VA Clinic 1925 Northeast Stucki Ave, Suite 300 Hillsboro, OR 97006

· Loren R. Kaufman VA Clinic 704 Veterans Drive The Dalles, OR 97058

· North Coast VA Clinic 91400 Neacoxie Street, Bldg. 7315 Warrenton, OR 97146

· Robert D. Maxwell VA Clinic 2650 Northeast Courtney Drive Bend, OR 97701

· Salem VA Clinic 1750 McGilchrist Street Southeast, Suite 130 Salem, OR 97302

· West Linn VA Clinic 1750 Southwest Blankenship Rd., Suite 300 West Linn, OR 97068

· VA Puget Sound Health Care System

· Edmonds VA Clinic 21616 76th Avenue West, Professional Center, Suite 112 Edmonds, WA 98026-7512

· Mount Vernon VA Clinic 307 South 13th Street, Suite 200 Mount Vernon, WA 98274-4100

· Olympia VA Clinic 500 Lilly Road Northeast, Suites 201 and 202 Olympia, WA 98506-5197

· North Olympic Peninsula VA Clinic 1114 Georgiana Street Port Angeles, WA 98362-4212

· Puyallup VA Clinic 11216 Sunrise Boulevard East, Suite 209, Building 3 Puyallup, WA 98374-8848

· Silverdale VA Clinic 9177 Ridgetop Boulevard NW Silverdale, WA 98383-8519

· Seattle VA Medical Center 1660 South Columbian Way Seattle, WA 98108-1532

· American Lake VA Medical Center 9600 Veterans Drive Southwest Tacoma, WA 98493-0003

· Mann-Grandstaff VA Medical Center

· Coeur d’Alene VA Clinic 915 West Emma Avenue Coeur d'Alene, ID 83814-2531

· East Front Avenue VA Clinic 624 East Front Avenue, Suite 201 Spokane, WA 99202-2139

· Mann-Grandstaff VA Medical Center 4815 North Assembly Street Spokane, WA 99205-6185

· Spokane VA Homeless Veterans Health 504 East 2nd Avenue Spokane, WA 99202-1406

· Spokane Valley CBOC 12509 E Mirabeau PKWY Spokane, WA 99216

· Elwood “Bud” Link VA Clinic 2530 Chester Kimm Road Wenatchee, WA 98801-8130

· Jonathan M. Wainwright Memorial VA Medical Center

· Jonathan M. Wainwright Memorial VA Medical Center 77 Wainwright Drive Walla Walla, WA 99362

· Yakima CBOC - 1211 Ahtanum Ridge Drive, Union Gap, WA, 98903

· Richland CBOC - 825 Jadwin Ave Ste 250 2nd Floor, Richland, WA, 99352-3589

· Morrow County PTCOC - 2 Marine Dr Suite 103, Boardman, OR, 97818

· Lewiston CBOC - 1630 23rd Avenue Building 2, Lewiston, Suite 301 and 401, ID, 83501-6350

· La Grande CBOC - 202 12th ST, LaGrande, OR, 97850-1186

· Wallowa County PTCOC - 401 Northeast 1st Street Suite A, Enterprise, OR, 97828-1186

· VA Southern Oregon Healthcare System

· White City VA Medical Center8495 Crater Lake Highway White City, OR 97503-3011

· Grants Pass VA Clinic 1877 Williams Highway Grants Pass, OR 97527

· Klamath Falls VA Clinic 2225 North Eldorado Boulevard Klamath Falls, OR 97601-6417

Point of Care Whole Blood Glucose Testing for VA Northwest Health Network, VISN 20.