6550--Point of Care Coagulation Testing (PT/INR) - Brand Name Only 36C24520Q0571 Huntington VAMC

This is a COMBINED SYNOPSIS/SOLICITATION for commercial items prepared in accordance with the format in Subpart 12.6 and is being conducted under FAR Subpart 13; simplified acquisition procedures apply. VA will conduct the procurement according to a combination of FAR Part 12, Acquisition of Commercial Items and Part 13, Simplified Acquisition Procedures as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; proposals are being requested and a written solicitation will not be issued. (ii) The solicitation number is 36C24520Q0571 and is issued as a Request for Quotation (RFQ). (iii) The provisions and clauses incorporated into this solicitation document are those in effect through Federal Acquisition Circular 2020-03, fiscal year 2020. Provisions and clauses incorporated by reference have the same force and effect as if they were given in full text. The full text of the Federal Acquisition Regulations (FAR) and Veterans Affairs Acquisition Regulations supplement (VAAR) can be accessed on the Internet at http://www.arnet.gov/far (FAR) and http://vaww.appc1.va.gov/oamm/vaar (VAAR) (iv) This requirement will use the cascading set-aside strategy, compliant with 38 U.S.C. 8127 (AKA Kingdom ware). The evaluation of offers received in response to this solicitation will use a tiered or cascading order of precedence. "Tiered evaluation of offers." also known as "cascading evaluation of offers," is a procedure used in negotiated acquisitions when market research is inconclusive for justifying limiting competition to small business concerns or sub-categories of small business concerns. Offers from both small and other than small business concerns will be evaluated in the following tier order: Service-Disabled Veteran-owned Small Business (SDVOSB), Veteran-owned Small Business (VOSB), all other small business concerns, other than small business. The North American Industry Classification System (NAICS) code is 325413, and the size standard is 1250 Employees. (v) This requirement consists of one (01) line item: DESCRIPTION QUANTITY PRICE T. COST Point of Care Coagulation Testing (PT/INR) YR $ Coagulation Test Strips - Yes Number of Boxes or Cases (Annual Commitment). 5500/Yearly Length of Agreement Base Plus 4 Options POP: 10-01-2020-09-30-2021 TOTAL COST $ (vi) To be acceptable, the proposal shall meet all requirements listed below in the SOW & the price must be reasonable. Statement of Work (SOW) for Hershel Woody William VAMC Point of Care INR Testing Introduction - This acquisition will secure a vendor to purchase point of care coagulation testing at the HERSHEL WOODY WILLIAMS VAMC in response to a Veterans Health Administration (VHA) Directive outlining the policies and procedures for the proper management of patients receiving therapeutic anticoagulation therapy. The information contained in this document will outline the minimum requirements necessary to provide a continuing level of patient care throughout the HERSHEL WOODY WILLIAMS VAMC health care systems. Background - Anticoagulants are commonly used for both treatment and prevention of cardiac disease, cerebral vascular accident, and thromboembolism in both the inpatient and outpatient setting. Their use and misuse carry a significant potential for patient harm. Subtherapeutic levels can increase the risk of thromboembolic complications while supratherapeutic levels can increase the risk of bleeding complications. Laboratory monitoring is a key component of safe anticoagulant therapy management. As of May 2009, it is the VHA policy that there must be a defined anticoagulant management program at each facility to individualize patient care provided and reduce the likelihood of patient harm associated with the use of anticoagulants. The frequency at which the patient must have testing to determine proper dosage and monitoring is set by the American College of Chest Physicians (CHEST) evidence- based guidelines. CHEST recommends that INRs be checked at no more than 4-week intervals for stable patients and for unstable patients the testing should occur more frequently. Due to the amount of testing and visits by the anticoagulant patient population the testing is being performed at several off-site locations to reduce the number of patients being seen at the main hospitals. Scope - To maintain the level of patient care already set, HERSHEL WOODY WILLIAMS VAMC must secure a vendor with specific requirements pertaining to the testing methodology, interface capability (Cerner Millennium, RALS and VistA), usability for operators, and feasibility of general oversight by the Ancillary Testing Department. To have testing available at the off-site locations, the testing must be FDA cleared as a CLIA waived analyte. The vendor must be able to interface their system with the current VA utilized VISTA system and pass all security measures to comply with VHA regulations. All software utilized by the vendor for the coagulation testing including middleware shall be on the TRM schedule as approved. Each healthcare system has individual needs that will need to be evaluated upon award. Those needs will be outlined as general needs in this document and will be further individualized once the award is granted. An adequate number of downloaders, meters, and supplies will be identified as well as the need for vendor services to include repair or replacement of meters and downloaders as they become inoperable. Objectives The overarching goal of this initiative is to continue the highest level of patient care and maximize cost effectiveness to the government. Increased levels of quality and accuracy are essential. Tasks General Requirements: The contractor shall provide an FDA cleared CLIA waived device capable of performing the PT/INR test. The vendor must comply with all state and federal agency requirements as mandated by the federal and state statutes. In addition, the contractor must be certified as meeting the requirements of the Department of Health and Human Services Clinical Laboratory Improvement Act of 1988. The Contractor shall be responsible for providing the necessary testing materials for the pre-analytical, analytical, and post-analytical phases of testing. The Contractor is responsible for providing the written evidence of all legally required licenses, certifications, and accreditation in accordance with Federal statutes to sell or distribute the necessary supplies to fulfill this award. Any proposed changes during the contract performance period must have prior approval by the Contracting Officer (CO). Changes to the requirements will be executed by a bilateral modification to the Contract. The Contractor shall only conduct business with designated Government personnel listed as points of contact (POC). Names of authorized personnel will be provided to the Contractor by the Government, in writing, and updated as necessary throughout the contract period. The Contractor must designate and submit in writing the names and telephone number of a full-time contract manager and alternate to the Contracting Officer. The Contract Manager will be responsible for the satisfactory performance of the required services. They will meet, as necessary, with HERSHEL WOODY WILLIAMS VAMC representatives or designees to discuss immediate administrative, technical issues, or problem areas involving the testing devices. Basic requirements for minimal government requirements: CLIA waived complexity Bidirectional Interface with VISTA and Cerner Millennium Connectivity with RALS web or UniPOC middleware programs (pre-existing in facilities) Meter weighs less than 16 ounces Direct sample dosing using capillary whole blood of less than 10 micro liters Test process time of less than 60 seconds. Reagent shelf life with greater than or equal to 12 months stability at room temperature Two levels of on-board quality control performed with every patient test Operator and patient identification tracking Rechargeable batteries A storage capacity of patient results of greater than 500 tests and a storage capacity of control results of greater than 25 tests. Service and Maintenance: The Contractor agrees to maintain the minimum acceptable service for technical situations by providing a working telephone number to speak with a service representative with knowledge of the device and technical ability to troubleshoot the device. The Contractor will also provide the necessary information to replace an inoperable device. A minimum acceptable service shall also include replacement and delivery of supplies with overnight service, but no longer than one (1) business day from the time of order. The Contractor policies and procedures shall comply with Health Insurance Portability and Accountability Act (HIPPA). If patient information is maintained on the devices the VA will not return the device for repair or replacement purposes. The device will be destroyed within the VA system with oversight from the departments of Biomedical Engineering, Logistics, and the Information Security Office. The Contractor will be responsible for replacing the destroyed meter with a working device of the same model and style currently utilized at the facility. Supplies: The Contractor shall provide all required hardware, software, and related consumables supplies to support the transmission of electronic data for each ordering facility at no additional cost. Any necessary additional required connections shall be the responsibility of the Contractor. All equipment, software, and hardware remain the property of the Government. All risks of loss remain the responsibility of the Contractor. The Contractor is not responsible for loss due to negligence, fire, water, or other natural disaster or damage from terrorism or war, and any other resultant damage to equipment, software, hardware and connections. Supplies necessary for continued service within HERSHEL WOODY WILLIAMS VAMC are as follows: Downloading (base unit) -cannot be wireless connectivity Meter with capability to hold operator, patient, and control information Rechargeable battery packs Quality Control solutions Patient test strips Interfacing with RALS Adequate number of download sites per facility Training at each facility Security Any security requirements of the Contracting personnel will be specified by the ordering facilities Information Security Officer (ISO). The requirements may apply to personnel, contractor property and/or information technology. The Contractor shall abide by the VAAR-852.273-75 SECURITY REQUIREMENTS FOR UNCLASSIFIED INFORMATION TECHNOLOGY RESOURCES (Interim Oct 2008), as stated in VA Handbook 6500.6. The contractor and their personnel shall be subject to the same Federal laws, regulations, standards and VA policies as VA personnel regarding information and information system security. These include, but are not limited to, Federal Information Security Management Act (FISMA), Appendix III of OMB Circular A-130, and guidance and standards, available from the Department of Commerce s National Institute of Standards and Technology (NIST). This also includes the use of common security configurations available from NIST s website at: http://checklists.nist.gov 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. 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. Prior to termination or completion of this contract, contractor/subcontractor must not destroy information received from VA, or gathered/created by the contractor while 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. 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 disclose protected health information, there is no business associate relationship. 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. To ensure that appropriate security controls are in place, contractors must follow the procedures set forth in VA Information and Information Security/Privacy Requirements for IT Contracts located at the following website: http://www.iprm.oit.va.gov 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. 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. The standard installation, operation, maintenance, updating, and patching of software shall not alter the configuration settings from the VA approved and FDCC configuration. Information technology staff must also use the Windows Installer Service for installation to the default program files directory and silently install and uninstall. 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 COTR. These provisions shall apply to all contracts in which VA sensitive information is stored, generated, transmitted, or exchanged by VA, a contractor, subcontractor or a third-party, or on behalf of any of these entities regardless of format or whether it resides on a VA system or contractor/subcontractor s electronic information system(s) operating for on the VA s behalf. Clauses (a) and (b) shall apply to current and future contracts and acquisition vehicles including, but not limited to, job orders, task orders, letter contracts, purchase orders, and modifications. Contracts do not include grants and cooperative agreements covered by 31 U.S.C. §6301et seq. These are found in VHA Directive 6210. Basically, computer system processing is sensitive, but unclassified information, and must have the appropriate security features. The following security requirements are in addition to the VHA Directive 6210 policy of initial and periodic security training and the need for physical controls to protect hardware. This computer system will be processing and transferring data that is classified as Sensitive but Unclassified (SBU) and must have the appropriate security features. Electronic transmission of identifiable patient information shall follow requirements of the Health Insurance Portability and Accountability Act (HIPAA). The following security requirements are in addition to the VAs basic policy of initial and periodic security training, and the need for physical controls to protect hardware. For example: Discretionary Access Control; (access control lists). Object Reuse; (hard drives/diskettes will be wiped clean of information before turned in to Acquisition/Logistics for transfer back to the Contractor). Identification and Authentication (user ID and passwords to use the system). Audit (the system must have audit trail capability). Operational Assurance (protection from external interference or tampering). Accreditation (signed by a designated accreditation authority). Period of Performance 1 base year Plus 4 option years General Definitions Contracting Officer (CO) Individual(s) at the VA National Acquisition Center (NAC) authorized to enter, administer, and/or terminate contracts and make related determinations and findings. The term includes certain authorized representatives of the contracting officer acting within the limits of their authority as delegated by the contracting officer. Contracting Officer s Technical Representative A Federal employee who assists the ordering/issuing agency contracting officer in the administration of task orders issued under this contract. The COTR is primarily responsible for the day-to-day program management of the ordering facility s task or task order. Ordering agencies may have different designators for this category. (e.g. GTR Government Technical Representative, COR Contracting Officer s Representative, etc.) Anticoagulant Therapy the therapeutic use of anticoagulants to discourage the formation of blood clots. Its main purpose is preventive; however, the thrombolytic action of an anticoagulant can destroy a clot and thereby improve the condition of the ischemic tissue supplied by the affected vessel. (vii) All material shall be delivered to Huntington VA Medical Center listed above. (viii) 52.212-1 Instructions to Offerors - commercial Items, applies to this acquisition. There are no addenda to the provision. (ix) 52.212-2, Evaluation - Commercial Items: FAR provision 52.212-2 does not apply to this solicitation. Award will be based on lowest price and meeting or exceeding Statement of Work requirements. (x) 52.212-3 Offeror Representations and Certifications - Commercial Items- the offeror shall complete only paragraph (b) of this provision if the offeror has completed the annual representations and certifications electronically via the System for Award Management (SAM) Website through http://www.sam.gov/portal. If the offeror has not completed the annual representations and certifications electronically, the offeror shall complete only paragraphs (c) through (p) of this provision. (xi) 52.212-4 Contract Terms and Conditions - Commercial Items: applies to this acquisition. (xii) 52.212-5 Contracts Terms and Conditions Required To Implement Statutes or Executive Orders - Commercial Items; the following FAR clauses identified at paragraph b of FAR 52,204-10; 52.212.5 are considered checked and are applicable to this acquisition: 52.204-10, 52.209-6, 52.219-13, 52.219-27, 52.219-28, 52.222-3, 52.222-19, 52.222-21; 52.222-26; 52.222-35, 52.222-36, 52.222-50, 52.223-18, 52.225-1, 52.225-3; 52.225-13, 52.232-34, 52.233-3, 52.233-4. (xiii) Any additional contract requirement(s) or terms and conditions determined by the Contracting Officer to be necessary for this acquisition and consistent with customary commercial practices will be addressed as necessary. (xiv) Proposals shall be submitted in writing to Mohsin Abbas at contact@example.gov on Friday, July 31, 2020 by 3:00 p.m.(EST) to the email addresses identified above. No quotes will be accepted through phone, fax. No late submissions of quotation(s) will be accepted. Quotes shall be submitted on company letterhead. Commercial format is encouraged. All quoters shall include the following information printed on each quote: Legal Business/Company Name (as it is indicated in www.sam.gov) DUNS Number. Contract Number. Warranty Information (Can be a separate attachment) Point of Contact Name Telephone number E-mail Address (xvi) Point of contact for this solicitation is Mohsin Abbas e-mail: contact@example.gov. All Inquires must be in writing.