S02 36C25722Q0466 Source Sought Notice - AMA Coagulation CPRR.docx

Sources Sought Notice Sources Sought Notice

GENERAL INFORMATION

SET-ASIDE

Network Contracting Office 17

5441 Babcock Road Ste. 302 San Antonio TX 78240

POINT OF CONTACT*

Contracting Officer Robyn Nussbaum robyn.nussbaum@va.gov

PLACE OF PERFORMANCE

P&LMS Section

6010 Amarillo Blvd West

Amarillo TX

ADDITIONAL INFORMATION

AGENCY’S URL

URL DESCRIPTION

AGENCY CONTACT’S EMAIL ADDRESS

EMAIL DESCRIPTION

DESCRIPTION

The Amarillo VA Health Care System (AVAHCS) in Amarillo, Texas is seeking Service-Disabled Veteran Owned Small Business (SDVOSB), Veteran Owned Small Business (VOSB), or Small Business sources capable of meeting the requirement listed below. The acquisition will be accomplished using commercial item procedures in accordance with FAR Part 12.

NOTE: TO QUALIFY SDVOSB AND VOSB VENDORS MUST BE CERTIFIED IN THE VA VENDOR INFORMATION PAGES (VIP) DATABASE.

The North American Industry Classification System (NAICS) is 334516. Any SDVOSB, VOSB, or Small Business firms who wish to identify their interests and capability to provide this product must provide product specifications, performance and delivery information by notifying the Contract Specialist no later than 4:00 PM Central Time, April 5, 2022. Notification shall be e-mailed to Robyn Nussbaum, at robyn.nussbaum@va.gov.

Any vendor who responds to this Notice must provide credentials to perform the requirement as outlined in the below scope.

DISCLAIMER

This Sources Sought Notice is issued solely for information and planning purposes only and does not constitute a solicitation. All information received in response to this Notice that is marked as proprietary will be handled accordingly. In accordance with the Federal Acquisition Regulation, 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 Notice.

1. SCOPE

The intent of the Amarillo Veterans Affairs Health Care System (AVAHCS) Pathology & Laboratory Medicine Service is to provide continuous, accurate, coagulation testing to providers. The desired proposal requires reagents, quality control materials, and consumables to be provided for approximately 74,000 coagulation tests analyzed over the next 60 months (8-1-2022 through 7-30-2027) on a cost-per-test (CPT) or cost per reportable result (CPRR) basis as an IDIQ for three (3) identical automated analyzers for the following locations:

These three (3) identical automated analyzers have been previously procured as a CPRR to perform the following assays on outpatient and inpatient population (associated annual volumes are estimated):

Quantitative D-Dimer

5 boxes of low control

aPTT

1.3. Background:

1.3.1 The Coagulation Department of the Amarillo VAHCS is a 24/7/365 operation that services the Amarillo area and the 50 surrounding countries in the Texas/Oklahoma Panhandle, New Mexico, and a small portion of Colorado. Amarillo VAHCS has a large outpatient population who visits the Hospital each day, and the four Community Based Outreach Clinics (Lubbock, TX; Childress, TX; Dalhart, TX; and Clovis, NM). Currently, the Amarillo and Lubbock Coagulation Department runs approximately 14,800 coagulation analytes per year and the past several years have seen a decrease in testing due to the SARS- CoV-2 pandemic.

1.3.2 For the past 5 years, the Coagulation Department located in Amarillo, TX has utilized two (2) CS2500 analyzers and one (1) CS2500 analyzer in Lubbock, TX.

1. 4. Performance Period:

1.4.1 See Price/Cost Schedule

1.4.2 Base year + four (4) Option Years

1.5. Type of Contract:

1.5.1 This is a firm fixed price contract for Indefinite Delivery/Indefinite Quantity (IDIQ) to include all reagents, calibrators, consumables, and service to be delivered upon the ordering facility and/or through metering data usage.

1.5.2 The Vendor must provide all equipment, reagents, calibrators, controls, consumable items, parts, accessories, ancillary devices, service plans, shipping costs, installation, validation studies, training, any other item required to establish instrument operation, and should be from the same family of analyzers as applicable and suitable for the facilities listed.

1.6. Amarillo VAHCS Contingency due to remodel of the AMA laboratory

1.6.1 Dependent of the dimensions of the coagulation analyzers, the vendor may be required to come and pick up analyzer(s) that cannot fit into the temporary core laboratory space at no additional charge to the Government due to lack of storage space to house the analyzer. Once remodeled, the analyzer may be re-installed into the laboratory as if there was not disruption of service and/or testing performance.

1.6.2 Suggested timeframe for the laboratory move into the temporary core lab space is projected to be October of 2022 but this time frame can change at any time.

1.6.3 The Lubbock laboratory will not undergo any new remodel during the POP of this contract: therefore, no analyzer(s) pickup will be required.

2. GENERAL REQUIREMENTS FOR COAGULATION EQUIPMENT/ANALYZERS

2.1 Instrumentation shall be from the same family of analyzers as applicable and suitable for the facilities listed.

2.2 The equipment models being offered shall be in current production as of the date this proposal 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 are not acceptable. Consideration of used equipment or current in-house equipment will not be accepted in the proposal.

2.5 All components –instrumentation, middleware, and reagents – shall be Food and Drug Administration (FDA)-approved.

2.7 Sufficient capacity and throughput to meet the volume and service demands as defined.

2.8 To be configurable to perform automatic on-board dilutions of all samples with out of range results or defined limits are exceeded.

2.9 Capability to program a test as a repeat with interfacing of results to overlay initial result.

2.10 The ability to continuously load patient specimens.

2.11 Be an open system which can accommodate at least 5 or more user-defined assays with ability of incorporating other manufacturer’s reagents

2.12 The ability to detect short samples and have clot detection with alert notification prior to the sample entering the probes.

2.13 Capable of primary tube sampling from various manufacturers and sizes of evacuated tubes.

2.16 Proven to have “zero to minimal” patient sample carryover.

2.17 Proven to have “zero to minimal” interfering factors that would affect the test results (such as hemolysis, lipemia, icterus, drug interference, etc.)

2.19 Ability to prioritize STAT testing without compromising existing programmed testing.

2.20 Minimal operator intervention to change a routine specimen to a STAT specimen, as well as introduce STAT specimens during a test run without aborting a run.

2.21 Be able to have calibration testing and quality control testing performed without excess delay to testing currently in progress.

2.22 The instrument systems shall have on-board reagent refrigeration as required.

2.23 The instrument systems shall have on-board, adjustable, color, touchscreen monitors that are easily readable and icon driven and user friendly.

2.26 As required, all required water systems, primary and backup, to supply deionized water for coagulation analyzers (filters, preventative maintenance, and repair) are the responsibility of the Vendor.

2.27 Safety features to avoid unnecessary exposure to biohazardous and chemical material.

2.29. Interface Requirements

2.29.4 If a site does not have a universal interface and one is needed to optimally interface the instrument, then the Vendor is responsible for the acquisition of the universal interface box and everything else needed to connect with VA computerized hospital information system.

2.30 Equipment/Analyzer Software

2.30.1 Trigger automatic repeat testing of critical samples.

2.30.2 Trigger reflex testing based on user-definable rules.

2.30.3 Allow for manual add-on testing of samples already loaded onto the instrument.

2.30.4 Track the processing of individual samples; to estimate the completion time of each analyte and to review any completed results on a patient sample, even if all analytes are not yet completed.

2.30.6 Show real-time on-board reagent inventory.

2.30.7 Alert user of low reagent volumes at user-definable thresholds.

2.30.8 Store calibration curves for at least four different lot numbers per analyte.

2.30.9 Operator may select to run a test on only a specified lot of reagents even though more than one lot has a valid calibration.

2.30.10 Transfer and archive patient results, calibration history, and quality control records onto external media, such as a CD/DVD disk or an external hard drive. Once archived, the on-board memory shall be able to be purged so that the operator can manipulate only the current dataset accumulating since the most recent archive date.

2.30.11 Store and re-transmit patient records, in case of interface downtime up to a minimum of 24 hours or longer.

2.30.12 View Operations Manuals and Troubleshooting Guides on the instrument monitor with pictures, diagrams, and video.

2.30.13 Program sample batch processing.

2.30.15 Ability to monitor instrument performance.

2.30.16 A bi-directional, bar-coded computer interface compatible with the VA laboratory information system. The interface (both hardware and software) shall be immediately available for implementation to the VA computerized hospital information system.

2.30.16.1 INTERFACE

DAWNING / INNOVATION

VISTA

(LIS)

INSTRUMENT

2.30.16.2 The following data fields will be collected:

2.30.16.3 Data is transferred from VISTA to a Dawning Secure Network Interface (SNI) device, which is then sent to the instrument, using the appropriate format. Once testing is complete, the instrument sends the result back to the SNI which then sends the result back to VISTA in the appropriate format.

2.30.16.4 All testing is performed by Pathology & Laboratory Medicine Service staff using appropriate procedures, access and verify codes. VA sensitive information is stored in the VISTA/LIS database and all records are backed up on disk and stored in a secure, location, (disks locked drawers behind locked doors) per regulations. Data will be available to providers using CPRS system.

2.30.17 Barcode reading accuracy must have less than a 1.0 % failure rate. Must have positive patient identification with barcode verification at analyzer

2.30.19 Vendor shall collaborate with lab to write/develop protocols to establish customer configurable rules to enhance workflow management and productivity.

2.31 Quality Control Program

2.31.1 Define multiple lots of the same control for simultaneous testing.

2.31.2 Perform quality control testing on all available lots and containers of a specific reagent when that reagent is selected for quality control analysis.

2.31.3 This should be automatic and not by manual selection.

2.31.4 Allow the operator to select which Westgard rules to apply.

2.31.5 Utilize weighted means and moving averages.

2.31.6 View and print daily, weekly, and monthly quality control results.

2.31.7 Document out-of-range quality control values.

2.31.8 Capability to record, store and print required quality control Levy-Jennings graphs., instrument maintenance information, patient demographic information and specimen results.

2.31.10 Quality control material will automatically be run on all lots of those reagents when the respective test is requested.

2.32 Reagent, Consumable, Quality Control Material & Calibrator Requirements

2.32.1 All reagents, buffers, substrates, controls, and calibrators required to run all assays shall be included in the cost-per-reportable-result proposal and shall not be listed as individually priced line items.

2.32.3 All consumables required to operate the instrument systems for the Amarillo VAHCS and Lubbock CBOC test menu assay-required consumables, shall be included in the cost-per-reportable-result proposal and shall not be priced separately.

2.32.5 Calibration(s) of on-board reagents per lot number should have a minimum stability of two (2) weeks or longer.

2.32.7 All freight charges are the responsibility of the Vendor.

2.32.9 Specific Assay Requirements- INR needs to be able to read greater than (>) 10 or above.

2.32.10 Vendor shall provide peer review and data reduction of quality control results to efficiently process approximately 13,050 coagulation tests per annum for AVAHCS in Amarillo, TX, and approximately 1750 coagulation test per annum for Lubbock CBOC in Lubbock, TX.

2.32.11 The vendor shall ship all the reagents, quality control materials, and consumables to:

To keep the inventory free of deterioration at the CBOC, the AVAHCS will allot the Lubbock VA CBOC reagents, quality control material, and consumables for no more than 2 weeks at a time upon request to re-supply.

3. ENVIRONMENTAL FACTORS AND UTILITIES REQUIREMENTS

3.1 The heat output of the automation and instrument system components, while operating at maximum capacity, and in conjunction with each other, shall be taken into consideration.

3.2 No piece of equipment shall have a noise output of more than 68 decibels when that equipment is performing at maximum operation.

3.6.4 The water filtration system shall make Type II laboratory-grade water, meeting the manufacturer’s requirements for the instrument systems.

3.6.7 The water filtration system shall have leak detection alarms, both audible and visible, and shall have bypass options to isolate individual filtration units.

3.8 System Management

3.8.1 Computer interface compatible with the current VA laboratory information system and existing universal interface.

3.8.2 The fully operational interface (both hardware and software) shall be immediately available for implementation to the VA computerized hospital information system.

3.8.3 The accuracy of the barcode reading must have less than a 1.0 % failure rate.

3.8.3.2 Equipment must accept, at a minimum, 10 characters in specimen identifier that is alpha, numeric, and/or alphanumeric concurrently.

3.8.4 The ability to detect processing errors and provide error notification.

3.9 Middleware System: Generally, a separate component/computer that electronically links the testing instrumentation to manage data, results, and workflow (Not to be confused with Data Innovations)

3.9.2.1 The middleware solution shall have the capability to create user- definable rules.

3.9.2.3 Instrument connection to middleware service shall be provided

3.9.3 The Vendor shall provide on-going middleware support to the Amarillo VAHCS and to the Lubbock CBOC for the life of the contract

3.9.3.1 This support shall include assistance with writing future rules, editing and troubleshooting.

3.9.3.2 The Vendor shall provide specific training to three (3) Amarillo VAHC personnel and two (2) Lubbock CBOC on how to create and edit rules, how to configure and manipulate the middleware program, and how to troubleshoot problems with the middleware solution.

3.9.3.3 Training on-site and/or at an off-site location, all costs associated with the training shall be included in the proposed cost-per-reportable result proposal.

3.9.4 The Vendor’s middleware solution shall have a successful history of interface with the Veteran Affair’s VISTA Laboratory Information System.

3.9.5 The Vendor shall provide software updates to the middleware solution as part of the cost-per-test contract proposal.

4. TRAINING REQIREMENTS

4.3 Utilization of the training slots will be mutually agreed upon between the Amarillo VAHCS and Lubbock CBOC and the Vendor.

4.4 Additionally, the Amarillo VAHCS and Lubbock CBOC is requesting four (4) training slots specific to the middleware solution offered in the proposal either to be on-site or off-site.

5. BILLING AND INVOICING

5.2 VA-FSC shall require the following information in compliance with the Prompt Pay Act and Business Requirements.

5.2.1 Your Taxpayer ID number (TIN)

5.2.2 Your “Remit Address” information

5.2.3 The VA Purchase Order (PO) number

5.2.4 Your contact information: (Personal name, Email, and Phone)

5.2.5 Your VA Point of contact information (Personal name, Email, and Phone)

5.2.6 The Period of Performance dates (POP Beginning and Ending)

5.2.7 All discount information if applicable (Percent and Date Terms)

5.2.8 Reagents used with pricing per unit

5.2.9 No freight charges to be added to the invoice

5.3 Department of Veterans Affairs Financial Service Center:

5.3.1 Phone:1-877-353-9791

5.3.2 Email: vafscched@va.gov

5.4 AVAHCS shall not be responsible for payment of services and or supplies which were not requested Accordance with the contract.

5.7 Invoices will be electronically submitted to the Tungsten website at:

5.7.1 http://ww.tungsten-network.com/uk/en/

5.7.2 Tungsten direct vendor support number is 877-489-6135 for VA contracts.

5.8 All invoices submitted through Tungsten to VA-FSC should mirror your current submission of Invoice.

6. SERVICE /MAINTENANCE REQUIREMENTS

6.2 Equipment repair service shall be provided 24/7 for AVAHCS Laboratory and 5 days/week between 8am – 5pm for Lubbock CBOC laboratory.

6.3 HOURS OF OPERATION

6.3.1 Normal hours of operations at the VAMC are Monday through Friday from 8:00 am to 4:30 pm, excluding holidays.

6.3.3 Federal Holidays observed by the VAMC are:

6.4 Equipment repair response time shall be no more than 24 hours.

6.5 Preventative maintenance will be performed as frequently as published in manufacturer’s operator’s manual and within 2 weeks of the scheduled due date.

6.6 A malfunction incident report shall be furnished upon completion of each repair call. The report shall include, at minimum, the following: date and time notified, date and time of arrival, serial number, type and model number of equipment, time spent for repair, and proof of repair to include documentation of a sample run of quality control verifying acceptable performance.

6.7 Each notification for an emergency repair service call shall be treated as a separate and new service call.

6.8 Support shall include remote management software including diagnostics for equipment. Remote access to equipment is not available at this time.

6.9 Vendor shall not access patient information during service and/or repairs.

7. SUPPPORT FEATRUES

7.2 The Vendor shall perform/assist with all validation studies listed below at no cost to the Government.

7.2.1 Correlation studies for each analyte

7.2.2 Linearity or Analytical Measurement Range (AMR) Validation shall be performed on proposed instrument(s) for each analyte to validate the reportable range.

7.2.5 Sensitivity/Specificity: efficiency, sensitivity, false positive rate, and false negative rate

7.2.6 Carryover Studies.

7.2.7 Reference Range- Reference range assessment must be performed for each lab.

7.2.8 Accuracy/Recovery

7.2.9 Calibration Verification

7.3 Method performance/comparison shall be consistent with current CLSI guidelines, College of American Pathologists (CAP) standards and Federal regulations.

8. OTHER

8.2 The Vendor shall remove all equipment within 90 days after notification of the expiration of the terms of this agreement but not until the completion of new vendor's equipment installation inclusive of completed cross over studies.

8.3 The Vendor shall be responsible for removing the hard drive and turning it over to the VA for destruction prior to removal of any analyzer.

8.4 The Vendor shall reimburse the facility for EXACT costs/supplies related to tests sent to a referral laboratory when testing is not available through no fault of the facility due to reagent problems, other product issues, or other vendor related factors. The assessed damages shall be applied to the invoice in the form of a credit or deduction.

8.7 This order should assist the Department of Veterans Affairs to pursue the goal of being a good steward in our community by eliminating, minimizing, or mitigating adverse environmental impacts.

9. CONFIDENTIALITY AND NONDISCLOSURE

It is agreed that:

9.1 The preliminary and final deliverables, and all associated working papers, application source code, and other material deemed relevant by VA which have been generated by the Vendor in the performance of this task order, are the exclusive property of the U.S. Government and shall be submitted to the CO at the conclusion of the task order.

9.2 The CO will be the sole authorized official to release, verbally or in writing, any data, draft deliverables, final deliverables, or any other written or printed materials pertaining to this task order. No information shall be released by the Vendor. Any request for information relating to this task order, presented to the contractor, shall be submitted to the CO for response.

9.3. Press releases, marketing material, or any other printed or electronic documentation related to this project, shall not be publicized without the written approval of the CO.

10. CONTRACTOR SECURITY REQUIREMENTS

10.1 The Vendor requires no access to AVAHCS or any VA information system. The Vendor’s analyzers will be compatible and interfaced to the AVAHCS information system. There will be supervised access when the Vendor is physically present for technical support, service calls, and scheduled preventative maintenance.

10.2 NO VA DATA OF ANY TYPE SHALL BE TRANSFERRED FROM THE VA.

10.3 The C&A requirements do not apply. A Security Accreditation Package is not required.

11. RECORDS MANAGEMENT

11.1 All records (administrative and program specific for AMA/LUB) created during the period of the contract belongs to AVAHCS and must be returned to AVAHCS at the end of the contract.

VHA Supplemental Contract Requirements for Ensuring Adequate COVID-19 Safety Protocols for Federal Contractors

1. Contractor employees who work in or travel to VHA locations must comply with the following:

3) Documentation cited in this section shall be digitally or physically maintained on each contractor employee while in a VA facility and is subject to inspection prior to entry to VA facilities and after entry for spot inspections by Contracting Officer Representatives (CORs) or other hospital personnel.

4) Documentation will not be collected by the VA; contractors shall, at all times, adhere to and ensure compliance with federal laws designed to protect contractor employee health information and personally identifiable information.

Contractor must immediately notify their COR or Contracting Officer if contract performance is jeopardized due to contractor employees being denied entry into VA Facilities.

Sources Sought Notice