Inactive

This is a Sources Sought announcement only. All responses will be used for market analysis in determining the availability of potential qualified businesses that may be used to determine appropriate a... This is a Sources Sought announcement only. All responses will be used for market analysis in determining the availability of potential qualified businesses that may be used to determine appropriate acquisition strategy. No solicitation is being issued at this time but may be issued later. The W.J.B. Dorn VA Medical Center in Columbia, SC is seeking a Contractor to provide analyzers, reagents, and peripherals necessary for the generation of a combination of the following test results: Troponin, Ionized Calcium, Creatinine, Activated Clotting Time (Kaolin), and other possible tests for cost per test (CPT). A single Analyzer is mandated to be able to perform all the above required tests and without any pretreatment of any type. The system must be redundant with respect to the POC Analyzer, having multiple identical Analyzers each capable of operating independent of the others. The testing performed must correlate with the laboratory instrumentation and testing to meet accreditation requirements. This requirement is needed for one (1) base year with four (4) one-year option periods. Period of Performance is estimated to begin 28 April 2022. Interested businesses are encouraged to respond to this notice via e-mail and provide their company name, associated DUNS number, and whether the items are available on an existing Federal Contract or the open market. This notice will be posted for a period of 4 business days, closing on Friday, 04 March 2022 at 2pm ET. All questions and responses pertaining to this notice should be forwarded to Lasonja Harvey via email at lasonja.harvey@va.gov. Statement of Work Point of Care Cost Per Test System GENERAL DESCRIPTION/OBJECTIVE: Contractor shall provide Contractor owned Analyzers and peripherals necessary for the generation of a combination of the following test results: Troponin, Ionized Calcium, Creatinine, Activated Clotting Time (Kaolin), and other possible tests under a cost-per-test agreement. A single Analyzer is mandated to be able to perform all the above required tests and without any pretreatment of any type. The system is required to be redundant with respect to the POC Analyzer, having multiple identical Analyzers each capable of operating independent of the others. The testing performed must correlate well with the laboratory instrumentation and testing to meet accreditation requirements. The Analyzer is a specialized instrument for the testing of specific parameters for whole blood for therapeutic monitoring and routine screening. The Analyzer offered by the Contractor shall be portable, bedside units for use primarily in the clinical areas of the hospital and outpatient clinics. Services shall be provided to the Laboratories as list under 1.1. DEFINITION/ACRONYMS: Glossary - Acronyms used in this Performance Work Statement are listed below for easy reference: CAP College of American Pathologists CO Contracting Officer COR Contracting Officer s Representative CPT Cost Per Test (CPT)is an all-inclusive price and includes: All Analyzer(s), printers, and necessary equipment. All reagents, consumables, standards, controls, parts, and any other item required for the proper operation of the Contractor s equipment (shipped at the instructions of each facility, at a mutually agreeable schedule at no extra charge to the Government). Equipment service through the swap out program including emergency repair, parts, and preventive maintenance Training for Government personnel on all three shifts. Contractors are required to provide delivery, installation, and removal of equipment at no additional charge. CVAHCS Columbia VA Health Care System EST Eastern Standard Time POC Point of Care PWS Performance Work Statement QASP Quality Assurance Surveillance Plan TJC The Joint Commission QC Quality Control VA Veterans Affairs VAMC VA Medical Center VISTA Veterans Information System and Technology Architecture PERIOD OF PERFORMANCE: Period of performance is for one base year with the possibility of four (4) 1-year option periods. Base Year: April 28, 2022 April 27, 2023 Option Year One April 28, 2023 April 27, 2024 Option Year Two April 28, 2024 April 27, 2025 Option Year Three April 28, 2025 April 27, 2026 Option Year Four April 28, 2026 April 27, 2027 HOURS OF OPERATION: Contractor to provide services from Monday through Friday, during the hours of 7:30 a.m. through 4:00 p.m. The following holidays are observed by the Federal Government and may include any other day specifically declared by the President of the United States to be a National Holiday. Services shall not be performed on these days. New Year s Day Martin Luther King s Birthday Presidents Day Memorial Day Juneteenth Independence Day Labor Day Columbus Day Veterans Day Thanksgiving Day Christmas Day LOCATION OF WORK: Columbia VA Healthcare System, WJB Dorn VA Medical Center, 6439 Garners Ferry Road, Columbia, SC 29209 GENERAL REQUIREMENTS: Contractor shall provide all equipment, reagents, standards, controls, printers, and any other item required for the proper operation of its Contractor owned Analyzers and peripherals necessary for the generation of a combination of the following test results: Troponin, Ionized Calcium, Creatinine, Activated Clotting Time (Kaolin), and other possible tests for cost per test (CPT). A single Analyzer is required to be able to perform all the above required tests and without any pretreatment of any type. The system must be redundant with respect to the POC Analyzer, having multiple identical Analyzers each capable of operating independent of the others. The testing performed is required to correlate with the laboratory instrumentation and testing to meet accreditation requirements. Offered models of clinical laboratory Analyzers shall be capable of producing accurate and reproducible assays on blood by established in vitro diagnostic methods. Models 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. Offered equipment shall be current state-of-the art equipment. Discontinued models will not be accepted. The Contractor shall provide all upgrades to the equipment hardware provided at no additional cost to the Government. These enhancements shall be delivered and installed at Columbia VA Healthcare System within sixty (60) calendar days of issuance to the commercial market. Only instruments, reagent cartridges, and supplies, which are FDA approved, shall be provided. Instruments must operate and interface with the UniPOC and WRX software at the time of award. The Middleware System utilized by the Analyzer must have a current TRM url and a current Acquisition Review Module (ARM) number. The Middleware System utilized by the Analyzer must be compliant with all Office of Information and Technology regulations. An operator s manual shall be furnished with each instrument supplied to the VA and updates to the manual shall be provided within sixty (60) calendar days of issuance to the commercial market. Contractor offered Analyzer shall conform to all facilities existing space constraints. The system must be a hand-held portable point of care unit, capable of being used at the bedside, and fit within an approximate 12 x 12 x 12 space. System is required to have positive sample identification to reduce possible sources of error/delay and to improve laboratory efficiency. The facility estimates that a quantity of 10-15 POC instruments will be required Annual Test Volume Estimates Troponin 7200 Creatinine 1500 Ionized Calcium 450 Activated Clotting Time (Kaolin) 350 Reagents, Supplies and Disposable: In the event that the consumables for the system are found to be defective and/or unsuitable for use with the Contractor s equipment, or the Contractor has failed to comply with the requirements for routing delivery of supplies, the Contractor is required to make commercially reasonable efforts to deliver the consumable supplies with twenty-four (24) hours of receipt of a verbal order for priority delivery from the Government activity. If either circumstance has occurred, the Contractor shall deliver to the Government site, in the most sufficient quantity as required to allow operation of the Contractor s equipment for one (1) week (under normal Government test lead 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 quarterly standing order/routine supplies delivery. These items shall be of the highest quality ensuring sensitivity, specificity and tested to assure precision and accuracy. The quality of the products shall be high enough to satisfy proficiency testing standards of the College of American Pathologists (CAP) and The Joint Commission (TJC) requirements. Maintenance and Repairs: Any instrument that malfunctions will be replaced by the Contractor at no additional cost to the Government. The Ancillary Testing Coordinator (ATC) or designee shall call the hotline and request instrument replacement. A new instrument is required to be immediately mailed to the site. A return postage shall be included with the new instrument to mail the malfunctioning instrument back to the Contractor. Emergency repairs of other components to the system shall be performed after notification that the equipment is inoperative. The Contractor shall provide the Government with a designated point of contact and shall make arrangements to enable this maintenance representative to receive such notification. The Contractor is required to perform emergency repair service within twenty-four (24) hours of time of notification of the malfunction except when an ordering facility elects reduced service at contract agreed reduction. The Contractor shall provide all parts and labor needed to repair the malfunction. Travel, per diem and other expenses associated with the repair shall be borne by the Contractor. The Contractor shall furnish a malfunction incident report to the installation upon completion of each maintenance call. The report shall include, as a minimum, the following: (a) Date and time of notification. (b) Date and time of arrival. (c) Serial number type and model numbers(s) of equipment. (d) Time spent for repair. (e) Description of malfunction. (f) Proof of repair. Parts (e) and (f) shall be written verification of quality control of the sample run. Training and Technical Service Training: The Contractor, without additional charge to the Government, shall provide in depth, on station technical training for key operator technologists (Ancillary Testing Coordinator and designee). Standardized on-site technical training for all ancillary testing personnel with regard to routine operations and maintenance of instrumentation will be provided at no extra cost to the Government. The Contractor shall 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. Training must be provided by the Contractor for all tours of duty and conducted in small groups to provide hands-on experience. The Contractor shall provide competency assessment protocols for use at each site and be consistent with federal regulations and current TJC standards. On-site technical training must be provided during the first two (2) months of installation, provided interface is operational and participating facilities are prepared for training. Contractor shall provide supplemental operating training to Government personnel, without additional charge to the Government, upon installation of the upgrade in equipment hardware with the operation of an instrument already furnished. SPECIAL REQUIREMENTS: The Contractor s unit shall have software/middleware that is fully VISTA and Cerner compatible, capable of simultaneous data transfer from the unit to the VISTA and Cerner System (without upgrade or other software modification to VISTA). System shall provide appropriate quality control analysis and all components necessary to interface with VISTA and Cerner. Shall have auto quality control to meet TJC standards (minimum 1 level per 8-hour shift). Provide QC lock out and operator lock out. QC shall be available in Levey Jennings format, or statistical reporting available. Shall provide a <5-minute turnaround time for tests other than immunoassay and coagulation tests which shall be <20-minutes. Shall have the ability of data management of patient and QC results with remote access. Shall provide calibrations per TJC requirements. Requires minimal maintenance. Shall provide ease of use. Shall be easy to troubleshoot. All controls and calibrators shall be included in the CPT. Instruments shall be moveable for transport to bedside without recalibration. Shall have the ability to test immunoassay troponin I with <11-minute turnaround time. TRANSITION PERIOD: The transition period for the Contractor to have all required Analyzer s, peripherals, consumables, training, correlation studies, reagents, controls, etc., installed and shall be fully operational shall be thirty (30) calendar days after award. Failure of the Contractor to conform to the transition period shall be considered as sufficient cause to terminate contract terms under the Termination for Cause clause of the contract. RECORD MANAGEMENT: Citations to pertinent laws, codes, and regulations such as 44 U.S.C. chapters 21, 29, 31 and 33; Freedom of Information Act (5 U.S.C. 552); Privacy Act (5 U.S.C. 552a); 36 CFR Part 1222 and Part 1228. Contractor shall treat all deliverables under the contract as the property of the U.S. Government for which the Government Agency shall have unlimited rights to use, dispose of, or disclose such data contained therein as it determines to be in the public interest. Contractor shall not create or maintain any records that are not specifically tied to or authorized by the contract using Government IT equipment and/or Government records. Contractor shall not retain, use, sell, or disseminate copies of any deliverable that contains information covered by the Privacy Act of 1974 or that which is generally protected by the Freedom of Information Act. Contractor shall not create or maintain any records containing any Government Agency records that are not specifically tied to or authorized by the contract. The Government Agency owns the rights to all data/records produced as part of this contract. The Government Agency owns the rights to all electronic information (electronic data, electronic information systems, electronic databases, etc.) and all supporting documentation created as part of this contract. Contractor must deliver sufficient technical documentation with all data deliverables to permit the agency to use the data. Contractor agrees to comply with Federal and Agency records management policies, including those policies associated with the safeguarding of records covered by the Privacy Act of 1974. These policies include the preservation of all records created or received regardless of format [paper, electronic, etc.) or mode of transmission [e-mail, fax, etc.] or state of completion [draft, final, etc.] No disposition of documents will be allowed without the prior written consent of the Contracting Officer. The Agency and its Contractors are responsible for preventing the alienation or unauthorized destruction of records, including all forms of mutilation. Willful and unlawful destruction, damage or alienation of Federal records is subject to the fines and penalties imposed by 18 U.S.C. 2701. Records may not be removed from the legal custody of the Agency or destroyed without regard to the provisions of the agency records schedules. Contractor is required to obtain the Contracting Officer s approval prior to engaging in any contractual relationship (sub-Contractor) in support of this contract requiring the disclosure of information, documentary material and/or records generated under, or relating to, this contract. The Contractor (and any sub-Contractor) is required to abide by Government and Agency guidance for protecting sensitive and proprietary information. CHARACTERIZATION OF WASTE: 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 make a determination if the waste is a hazardous waste or otherwise regulated. The determination and description shall address the following: Waste toxicity (Reference 40 CFR §261.11 and 40 CFR § 261.24) Waste ignitability (Reference 40 CFR §261.21) Waste corrosivity (Reference 40 CFR § 261.22) Waste reactivity (Reference 40 CFR § 261.23 Hazardous waste from non-specific sources (F-listed) (Reference 40 CFR § 261.31) Discarded commercial products (acutely toxic or P-listed and toxic or U-listed) (Reference 40 CFR § 261.33) Solid Waste (Reference 40 CFR § 261.2) Exclusions (Reference 40 CFR § 261.4) 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 Publicity 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, thimersol 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/measures of the elements and parameters listed below and must be included with Contractor 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 be higher than 200 F) BOD: Biochemical Oxygen Demand) The documentation the Contractor provides shall be used to work with the VAMC and the public and/or private organization (e.g., POTW) to determine whether or not the waste form each device can legally be disposed of via the sewerage system. Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule: Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule. The HIPAA Privacy Rule promulgates rules governing the security, use and disclosure of Protected Health Information (PHI) by covered entities, including Federal agencies such as the Department of Veterans Affairs (VA). A covered agency must obtain satisfactory written assurances from its business associates that they will appropriately safeguard PHI that is received from or created on behalf of the agency. The VA contracting officer has determined that HIPAA is applicable to an offer that is submitted under this schedule, the offeror will be required to enter into a Business Associate Agreement (BAA) with the agency prior to the effective date of the contract. The BAA will describe the permitted and required uses of PHI by the offeror; provide that the offeror will not use or further disclose the PHI other than as permitted or required by the contract or by law; and require the offeror to use appropriate safeguards to prevent unauthorized disclosure of the PHI. VA INFORMATION AND INFORMATION SYSTEM SECURITY AND PRIVACY: All Contractor employees working on VA property must wear badges that are issued by the Police and Security Department. Contractor employees are required to wear the badges at all times while on VA property and must turn them into the Police and Security Department prior to leaving VA property. When Contractor employees are working in an area where there is highly sensitive information, there must be a VA employee present at all times during this period. The Contractor must have remote monitoring of Analyzers. The Contractor must have a fully functional VPN (Virtual Private Network) based bi-directional interface account established with the federal Government. Contractor shall provide VISTA/LEDI (Laboratory Electronic Data Exchange) laboratory interface system as approved by the VA National Security Operation Center. A copy of the VPN must be included in your response. A. GENERAL 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. B. ACCESS TO VA INFORMATION AND VA INFORMATION SYSTEMS 1. 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. 2. 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. 3. Contract personnel who require access to national security programs must have a valid security clearance. National Industrial Security Program (NISP) was established by Executive Order 12829 to ensure that cleared U.S. defense industry contract personnel safeguard the classified information in their possession while performing work on contracts, programs, bids, or research and development efforts. The Department of Veterans Affairs does not have a Memorandum of Agreement with Defense Security Service (DSS). Verification of a Security Clearance must be processed through the Special Security Officer located in the Planning and National Security Service within the Office of Operations, Security, and Preparedness. 4. Custom software development and outsourced operations must be located in the U.S. to the maximum extent practical. If such services are proposed to be performed abroad and are not disallowed by other VA policy or mandates, the Contractor/subcontractor must state where all non-U.S. services are provided and detail a security plan, deemed to be acceptable by VA, specifically to address mitigation of the resulting problems of communication, control, data protection, and so forth. Location within the U.S. may be an evaluation factor. 5. The Contractor or subcontractor must notify the Contracting Officer immediately when an employee working on a VA system or with access to VA information is reassigned or leaves the Contractor or subcontractor s employ. The Contracting Officer must also be notified immediately by the Contractor or subcontractor prior to an unfriendly termination. C. VA INFORMATION CUSTODIAL LANGUAGE 1. Information made available to the Contractor or subcontractor by VA for the performance or administration of this contract or information developed by the Contractor/subcontractor in performance or administration of the contract shall be used only for those purposes and shall not be used in any other way without the prior written agreement of the VA. This clause expressly limits the Contractor/subcontractor s rights to use data as described in Rights in Data General, FAR 52.227-14(d) (1). 2. VA information should not be co-mingled, if possible, with any other data on the Contractors/subcontractor s information systems or media storage systems in order to ensure VA requirements related to data protection and media sanitization can be met. If co-mingling must be allowed to meet the requirements of the business need, the Contractor must ensure that VA s information is returned to the VA or destroyed in accordance with VA s sanitization requirements. VA reserves the right to conduct on-site inspections of Contractor and subcontractor IT resources to ensure data security controls, separation of data and job duties, and destruction/media sanitization procedures are in compliance with VA directive requirements. 3. Prior to termination or completion of this contract, Contractor/subcontractor must not destroy information received from VA, or gathered/created by the Contractor in the course of performing this contract without prior written approval by the VA. Any data destruction done on behalf of VA by a Contractor/subcontractor must be done in accordance with National Archives and Records Administration (NARA) requirements as outlined in VA Directive 6300, Records and Information Management and its Handbook 6300.1 Records Management Procedures, applicable VA Records Control Schedules, and VA Handbook 6500.1, Electronic Media Sanitization. Self-certification by the Contractor that the data destruction requirements above have been met must be sent to the VA Contracting Officer within 30 days of termination of the contract. 4. The Contractor/subcontractor must receive, gather, store, back up, maintain, use, disclose and dispose of VA information only in compliance with the terms of the contract and applicable Federal and VA information confidentiality and security laws, regulations, and policies. If Federal or VA information confidentiality and security laws, regulations and policies become applicable to the VA information or information systems after execution of the contract, or if NIST issues or updates applicable FIPS or Special Publications (SP) after execution of this contract, the parties agree to negotiate in good faith to implement the information confidentiality and security laws, regulations, and policies in this contract. 5. The Contractor/subcontractor shall not make copies of VA information except as authorized and necessary to perform the terms of the agreement or to preserve electronic information stored on Contractor/subcontractor electronic storage media for restoration in case any electronic equipment or data used by the Contractor/subcontractor needs to be restored to an operating state. If copies are made for restoration purposes, after the restoration is complete, the copies must be appropriately destroyed. 6. If VA determines that the Contractor has violated any of the information confidentiality, privacy, and security provisions of the contract, it shall be sufficient grounds for VA to withhold payment to the Contractor or third party or terminate the contract for default or terminate for cause under Federal Acquisition Regulation (FAR) part 12. 7. If a VHA contract is terminated for cause, the associated BAA must also be terminated and appropriate actions taken in accordance with VHA Handbook 1600.01, Business Associate Agreements. Absent an agreement to use or disclosure protected health information, there is no business associate relationship. 8. 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. 9. The Contractor/subcontractor s firewall and Web services security controls, if applicable, shall meet or exceed VA s minimum requirements. VA Configuration Guidelines are available upon request. 10. Except for uses and disclosures of VA information authorized by this contract for performance of the contract, the Contractor/subcontractor may use and disclose VA information only in two other situations: (a) in response to a qualifying order of a court of competent jurisdiction, or (b) with VA s prior written approval. The Contractor/subcontractor must refer all requests for, demands for production of, or inquiries about, VA information and information systems to the VA contacting officer for response. 11. Notwithstanding the provision above, the Contractor/subcontractor shall not release VA records protected by Title 38 U.S.C. 5705, confidentiality of medical quality assurance records and/or Title 38 U.S.C. 7332, confidentiality of certain health records pertaining to drug addiction, sickle cell anemia, alcoholism or alcohol abuse, or infection with human immunodeficiency virus. If the Contractor/subcontractor is in receipt of a court order or other requests for the above-mentioned information, that Contractor/subcontractor shall immediately refer such court orders or other requests to the VA contracting officer for response. 12. For service that involves the storage, generating, transmitting, or exchanging of VA sensitive information but does not require C&A or an MOU-ISA for system interconnection, the Contractor/subcontractor must complete a Contractor Security Control Assessment (CSCA) on a yearly basis and provide it to the COR. D. INFORMATION SYSTEM HOSTING, OPERATION, MAINTENANCE, OR USE 1. For information systems that are hosted, operated, maintained, or used on behalf of VA at non-VA facilities, Contractors/subcontractors are fully responsible and accountable for ensuring compliance with all HIPPA, Privacy Act, FISMA, NIST, FIPS, and VA security and privacy directives and handbooks. This includes conducting compliant risk assessments, routine vulnerability scanning, system patching and change management procedures, and the completion of an acceptable contingency plan for each system. The Contractor s security control procedures must be equivalent, to those procedures used to secure VA systems. A Privacy Impact Assessment (PIA) must also be provided to the COR and approved by VA Privacy Service prior to operational approval. All external Internet connections to VA s network involving VA information must be reviewed and approved by VA prior to implementation. 2. Adequate security controls for collecting, processing, transmitting, and storing of Personally Identifiable Information (PII), as determined by the VA Privacy Service, must be in place, tested, and approved by VA prior to hosting, operation, maintenance, or use of the information system, or systems by or on behalf of VA. These security controls are to be assessed and stated within the PIA and if these controls are determined not to be in place, or inadequate, a Plan of Action and Milestones (POA&M) must be submitted and approved prior to the collection of PII. 3. Outsourcing (Contractor facility, Contractor equipment or Contractor staff) of systems or network operations, telecommunications services, or oth...