Inactive Service-Disabled Veteran-Owned Small Business (SDVOSB) Set-Aside (FAR 19.14)

PERFORMANCE WORK STATEMENT Radiology Services The Atlanta Veterans Affairs Health Care System, 1670 Clairmont Road, Decatur, GA 30033, herein called ATL VAHCS is requesting a contractor to provide mob... PERFORMANCE WORK STATEMENT Radiology Services The Atlanta Veterans Affairs Health Care System, 1670 Clairmont Road, Decatur, GA 30033, herein called ATL VAHCS is requesting a contractor to provide mobile Magnetic Resonance Imaging (MRI) equipment / operations to provide exams for the ATL VAHCS Veterans. BASICS B1. Requirements: The contractor will provide a mobile, handicap-accessible, magnetic resonance imager (mobile MRI) for comprehensive services. B2. Authority: This procurement is executed under: The Enhanced Sharing Authority, Public Law 104-262, Title 38 U.S.C. 8153 [The Government, under this authority reserves the right to sell excess capacity.]; The procedures described in FAR Subpart 12.6 and Part 15, as updated through FAC 2001-25 and as supplemented with information included in this solicitation; VHA Handbook 1105.02, Nuclear Medicine Service and Radiation Safety; VHA Handbook 1105.05, Magnetic Resonance Imaging Safety; Title 38 United States Code 7301 (b); and Title 38 Code of Federal Regulations 17.38. STATEMENT OF WORK Specifications (mobile MRI): ATL VAHCS Radiology Service Operational Point of Contact Ken Smith Clinical MRI Supervisor Radiology Service ATL VAHSC Decatur, GA 30033 tel: 404-321-6111 extension; 1184 / 2772 The Contractor shall provide a mobile magnetic resonance imager (mobile MRI) to perform the following examinations: Head (including brain, posterior fossa, temporomandibular Joint (TMJ), pituitary gland, and acoustic nerve) Cervical spine (including spinal cord) Thoracic spine (including spinal cord) Lumbar spine (including spinal cord) Spine Extremities (single coil) Abdomen (single coil) Pelvis General Requirements (mobile MRI): The MRI unit(s) will be available for patient exams five (5) days per week, excluding Federal Holidays, i.e. New Year s Day, Martin Luther King, Jr s. Birthday, Presidents Day, Memorial Day, Independence Day, Labor Day, Columbus Day, Veterans Day, Thanksgiving, Christmas and any other days specifically declared by the President of the United States to be national holidays. The equipment is to be used for federal government contract work only. Contractor will be solely responsible for all driver-staffing issues related to the mobile MRI. Contractor will perform arrival, set-up, take-down, and departure of mobile MRI in a manner that results in limited or no disruption to normal operations of the ATL VA Clinic. Contractor will perform arrival and departure such that the mobile MRI operates full days (7AM-5PM). Contractor will be solely responsible for all technologist and other staffing issues related to operation of the mobile MRI. The Contractor will provide each day a clean mobile MRI and dispose of trash in a responsible manner Mobile Equipment: A state-of-the-art self-shielded big-bore magnet (60cm or larger) shall be provided. Its strength shall be 1.5 Tesla or greater. The Contractor shall provide a detachable table that is rated for scanning patients with weight up to 450lbs or greater. The technology shall be Digital Imaging and Communication (DICOM) compatible and be such that it can and will be integrated with the ATL VAHCS Radiology Service PACS and Vista Rad PACS. The unit shall be such that it has not exceeded the five (5) years manufacturer s original life cycle. The last two (2) years of Preventative Maintenance records of the contracted unit(s) and all corrective action records relevant to operation and repair within the last 2 years shall be provided. All corrective action records relevant to repairs of the unit(s) during the contracted period of performance will be made available to ATL VAHCS Radiology and ATL VAHCS Biomedical Engineering personnel upon request. The equipment shall have the capabilities necessary to perform the following: Dedicated imaging protocols for head and spine applications Optimum water or fat selective excitation imaging, in multi-slice or 3D volume technique Pre-pulses that achieve suppression of blood signal for optimum myocardial and lumen visualization in cardiac and vascular imaging Dedicated imaging protocols for orthopedic applications High quality imaging for assessment of lesions in all anatomical areas Complete clinical studies that are selectable at a single touch Performance of automatic planning method based on flexibility to choose three anatomical landmarks Copying of all examination parameters from any previous scan to a new acquisition Selection of image matrix sizes freely up to 1024 X 1024 Dynamic studies with all imaging methods allowing entire scans to be repeated multiple times Manual start controlled from the gantry or operator s console Various motion and artifact reduction techniques Spin echo Fast field echo Turbo field echo Turbo spin echo Echo planar imaging Inversion recovery Time of flight imaging Phase contrast imaging Quantitative flow studies Imaging using 3D k-space shutter Pre-pulses (pre-saturation, magnetization transfer contrast, fat saturation) Movie for sequential display of up to 24 slices or dynamics/phases Rapid T2 Weighted MR Imaging The MRI shall be capable of performing 1mm thick scan images. The unit(s) will be in compliance with all federal safety and shielding regulations. Except for electricity and telephone, the unit shall have its own utilities to function independently of the ATL VA Clinic. Telephone wiring: See attached page 1 of 2 The Contractor shall be responsible for all maintenance, upgrades, updates, and servicing of Contractor owned equipment during the contract period. All responsibilities in line g will be scheduled and coordinated to be performed after business hours with the COR. The unit(s) will be equipped with a hydraulic lift to accommodate a wheel chair or to accommodate a stretcher and the person transporting the patient. Emergency crash cart with special oxygen tanks and regulators, if needed One MRI safe stretcher and one MRI safe wheelchair Utilities and Government Furnished Materials: Fiber reinforced concrete pad Power outlet located approximately 25 feet from the pad [The contractor must provide the needed power requirements. An example of power requirements would be 480 volts, 3 phase, 150 amps, 112 kVA.] Water for MRI unit, if needed One (1) telephone line located near the power outlet One computer terminal with ATL VAHCS Radiology PACS network access Telephone instruments as needed for the mobile unit(s) Restroom facilities within a reasonable walking distance Provide all supplies, including basic consumables and linens, required to perform the MRI examinations. Supplies: The Contractor will be responsible for providing all necessary cryogen. The Contractor will provide a clean mobile MRI and dispose of trash in a responsible manner. Special Requirements: The Contractor will provide all services listed in BASICS B1. Requirements above, to the Atlanta VAHCS, 1670 Clairmont Road, Decatur, GA 30033; at the ATL VA Clinic, in strict accordance with the terms and conditions of this contract. Resources: The resources specified in this contract may be charged only by written modification by the assigned VISN 7 VA Contracting Officer. The MRI services to be performed by the Contractor will be under the direction of the Chief, Radiology Service, ATL VAHCS. The resulting contract is a non-personnel services contract under which the personnel rendering services are not subject, either by the contract terms or by the manner of its administration, to the supervision and control usually prevailing in relationships between the Government and its employees. Term of Contract: The contract is effective for one (1) year base period and four (4) 12-month option period with an expected award date that is to be TBD. Funds for option period will be subject to the availability of funds. Service will not be performed by the Contractor after the ending date of this contract, until the Contracting Officer authorizes such services in writing. Point of Contact: Sally Vaughn, COR II Radiology Administrative Officer, Radiology Department 1670 Clairmont Road Decatur, GA 30033 404-321-6111;123564 Mobile Unit Staffing: The Contractor will be solely responsible for hiring, training, and compensating the MRI technologists and assistants needed to perform MRI examinations. It is required that staffing levels be such that the mobile units operate competently, professionally, and efficiently. All technologists will have all credentials necessary to work as such within the VA system. All technologists will have current certifications in basic life support procedures. All technologists will maintain all immunizations required of practicing medical professionals. All technologists will adhere to all relevant radiation safety practices and relevant magnetic safety practices. All technologists will work in a professional manner at all times. Study Quality: The Contractor will provide the ATL VAHCS a study-quality standard (a binder and/or CD of data and studies) that reflects the quality of the studies the provider is prepared to insure will be maintained throughout the duration of the contract. Examples of most, if not all, study types to be performed will be included in the study-quality standard. Quality Control: The Contractor will have a documented quality assurance program and provide the ATL VA HCS copies of quality assurance documents. The program will comply with all relevant TJC and HIPPA standards. The Contractor will have readily available several phantoms that can be used to determine MRI parameters. Phantom studies will be conducted as needed to test and insure study quality. Site Maintenance: The ATL VA HCS will be responsible for maintenance of a concrete pad appropriate for support and location of the mobile units. The ATL VA HCS will be responsible for maintenance of connectivity ports appropriate for linking the mobile units to power, computer network, and local-access phone/modem/fax as needed. The telephone technology will include one line dedicated for direct access to the code emergency response line in the ATL VA Clinic. The emergency phone line must be a dedicated sole use line. The ATL VAHCS will be responsible for connectivity from within the ATL VA Clinic to connectivity ports located outside the ATL VA Clinic facility at the site of the pad. The Contractor will be responsible for connectivity from within the mobile units to the connectivity ports of the ATL VA Clinic. Pre-operation Contractor/ATL VA HCS Tests of Mobile Units: The Contractor and ATL VA HCS personnel will conduct tests of the mobile units when they are first located. The tests will be performed to insure the units are working properly, to insure all needed/desired connectivity s are functioning properly, and to insure functionality is such that the conditions of this contract are met prior to the date of award. Service Contracts: The Contractor will have, throughout the period of the contract, a service contract with the vendors of the mobile units. These service contracts will include service on the MRI, and on any peripherals required to insure connectivity to the ATL VAHCS Radiology Service PACS. No routine maintenance will be scheduled or performed such that it conflicts with the imaging schedules of the mobile MRI. No maintenance will be scheduled or performed during scheduled scanning hours except to address emergency failures of the mobile units. Service response time to emergency failures should be within two hours. Medical Records: Clinical and/or other medical records, including images in DICOM form, of VA beneficiaries treated by the Contractor will be forwarded to the ATL VAHCS and shall remain the property of the US Government. The ATL VA HCS will own solely the data/images of the examinations and studies performed on the mobile unit. Insurance: The Contractor will provide proof of liability and workers compensation, a certificate of insurance providing evidence of liability coverage including the name of the insurance carrier, limits of liability and type of coverage (Ref: VAAR 852.237-7, Indemnification and Medical Liability Insurance). Medical Emergencies: The Contractor will provide to the ATL VAHCS written emergency plans addressing emergencies such as patient codes, personal injury, fire, and disruptive behavior. Regulatory Adherence: The Contractor is responsible for adhering to all relevant regulations regarding patient care, medical practice, use of contract agents, use of radiopharmaceuticals, operation of PET technology, CT technology, and MRI technology. Examples of relevant regulations are those of NHPP, OSHA, TJC, NRC, VHA, and various other federal agencies. Quality and Contract Monitoring: The Contractor will be monitored through a variety of mechanisms appropriate to VA regulations and policies. The Contracting Officers Technical Representative (COR) (114) will be responsible for monitoring the quality of services provided under this contract. 4. Payment: The ATL VAHCS agrees to reimburse the Contractor on a unit basis for resources furnished at the price listed in the schedule of this contract. The Contractor will be paid monthly, in arrears, upon receipt of a properly prepared invoice. The invoice shall include at a minimum: invoice number, invoice amount, Contract s name and address, contract number, purchase order number and period of performance. The Contractor will provide backup document to COR for verification of amount invoiced. Backup document shall include invoice number, Contractor s name and address, the contract number, purchase order number, date of exam, type of exam, referring physician s name, invoice amount and any additional cases. Invoices will be reconciled with VA record prior to disbursement of payments. The Contractor shall submit all invoices to the following address: FSC VA (667) PO BOX 149971 Austin, TX 78714-8971 Administration of Contract: The Contractor shall contact the Contracting Officer on all matters pertaining to the administration of this contract. Only the Contracting Officer is authorized to make changes that will affect the price, quantity, quality, or delivery terms of this contract. 6. Conflict of Interest: The Contractor shall not employ any person who is an employee of the United States Government if the employment of that person would create a conflict of interest. The Contractor shall not employ any person who is an employee of the Department of Veterans Affairs. Nor shall the Contractor employ any person who is a member of the immediate family of a VA employee, if the employment of that family member would create a conflict of interest, or the appearance of a conflict of interest, particularly with regard to influencing the contract negotiations, terms of the contract or the work carried out under the contract. In any such case VA must review the matter and give its approval in accordance with agency ethics rules. Contract Monitoring Procedures: At the time of contract award, the Contracting Officer will appoint a Contracting Officer Technical Representative (COR) to assist with the contract monitoring requirements. The COR will monitor such items as quality of service, timeliness of performance, customer service, cost control business relations. In accordance with FAR 1.601 (a) Contracts may be entered into and signed on behalf of the Government only by contracting officers. A COR is not authorized to modify the stated terms of the contract, including extending the length of the contract period. Quality of service will be monitored through a continuous review of requested studies vs. performed studies, the appropriateness of images produced and morbidity and mortality figures. These factors will be rated by a consensus of radiologists interpreting the MRI studies and through a radiologist or resident in the MRI unit setting protocols for scan and observing patients and procedures through the study process. Timeliness of performance will be measured through daily workload counts compared to daily number of studies ordered. Customer service will be monitored through periodic unannounced visits to the MRI unit and through patient satisfaction surveys completed by MRI patients. Cost control will be monitored through a comparison of overtime hours worked and the type and number of studies completed per day. Appropriate regulatory and accrediting standards will apply and all adverse events will be reported in accordance with medical center and other applicable guidelines. The delegated COR will notify the Contracting Officer of any non-compliance immediately upon his/her gaining knowledge of any such situation or incident. Initial communication of such may be communicated by telephone. After such communication, the COR will provide a written statement to the Contracting Officer along with any supporting documentation regarding the performance failure noticed. Upon receipt of a proper invoice, the COR shall certify that the services identified have been performed. Once certification has been made, the invoice will be forward through the proper billing channels and payment shall be made to the Contractor. Both parties shall jointly conduct a review of Contractor s performance to evaluate if services being provided are in accordance with the contract terms and if payments and billings are being properly handled. This review shall include, but is not limited to: analysis of all billings, payments, costs, administrative issues, patient satisfaction, quality of care and other related documentation that identifies that services have been received. Any concerns need to be brought to the Contractor/COR s attention at the time noted rather than an agreement reached prior to the expiration of services provided and consideration being received are satisfactory. Upon conclusion of the initial contract period and all option periods, and in coordination with the Contracting Officer, the using service shall provide a statement to the Contracting Officer providing a summary of Contractor s actions and a statement that all requirements of the contract were fulfilled as agreed. This information shall be forwarded by the COR to the Contracting Officer at least 90 days prior to the end of base period and each option period if option periods are included. Locations: The ATL VAHCS, including the Radiology Service is located at: Atlanta Veterans Affairs Medical Center 1670 Clairmont Road Decatur, GA 30033 The mobile MRI are to be sited at: Atlanta Veterans Affairs Clinic 250 N Arcadia Ave Decatur, GA 30030 INFORMATION SECURITY a. IT access: All Contractor personnel accessing Veterans Health Information and Technology architecture (VISTA, etc.) system will be required to sign and abide by all VA security policies and applicable confidentiality statues and the privacy act. b. Patient confidentiality: Contractor to maintain the confidentiality of patient records in accordance with the Privacy Act. HIPAA and all VHA Privacy regulations. c. Security requirements: Contractor shall insure the confidentiality of all patient and employee information and are subject to the completion of all mandatory training specified by the VHA. d. Employee Background Checks: Contractor(s) are required to have background investigations initiated; to include finger prints, PRIOR to start of contract. Contractor(s) will have completed VA Information Security and Privacy along with Rules of Behavior from the following link https://www.ees-learning.net/librix/loginhtml.asp?v=librix prior to start of contract and will compete on an annual basis, before the expiration of previous training. The contractor, when notified of an unfavorable determination by the Government, shall withdraw the employee from consideration from working under the contract. ACCESS TO VA INFORMATION AND VA INFORMATION SYSTEMS a. A contractor/sub-contractor 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. b. 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. c. 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. d. Custom software development and outsourced operations must be 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. e. 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. f. All contractor employees and subcontractor employees requiring access to VA information and VA information systems shall complete the following before being granted access to VA information and its systems: (01) Sign and acknowledge (either manually or electronically) understanding of and responsibilities for compliance with the Contractor Rules of Behavior, Appendix E relating to access to VA information and information systems; (02) Successfully complete the VA Cyber Security Awareness and Rules of Behavior training and annually complete required security training; (03) Successfully complete the appropriate VA privacy training and annually complete required privacy training; and (04) Successfully complete any additional cyber security or privacy training, as required for VA personnel with equivalent information system access [to be defined by the VA program official and provided to the Contracting Officer for inclusion in the solicitation document e.g., any role-based information security training required in accordance with NIST Special Publication 800-16, Information Technology Security Training Requirements.] g. The contractor shall provide to the Contracting Officer and/or the COR a copy of the training certificates and certification of signing the Contractor Rules of Behavior for each applicable employee within 1 week of the initiation of the contract and annually thereafter, as required. h. Failure to complete the mandatory annual training and sign the Rules of Behavior annually, within the timeframe required, is grounds for suspension or termination of all physical or electronic access privileges and removal from work on the contract until the training and documents are complete. i. Due to the threat of data breach, compromise or loss of information that resides on either VA-owned or contractor-owned systems, and to comply with Federal laws and regulations, VA has developed an Information and Information Technology Security clause to be used when VA sensitive information is accessed, used, stored, generated, transmitted, or exchanged by and between VA and a contractor, subcontractor or a third party in any format (e.g., paper, microfiche, electronic or magnetic portable media). 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 Web site at: http://checklists.nist.gov/. To ensure appropriate security controls are in place, contractors must follow the procedures set forth in VA Information and Information System Security/Privacy Requirements for IT Contracts located at the following Web site: http://www.iprm.oit.va.gov/ (852.273-75, Security Requirements for Unclassified Information Technology Resources). The contractor, their personnel, and their subcontractors shall be subject to the Federal laws, regulations, standards, and VA Directives and Handbooks regarding information and information system security as delineated in this contract. VA INFORMATIONAL CUSTODIAL TERMS a. 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). b. 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. c. 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. d. 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. e. 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. f. 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. g. 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. h. 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. i. 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. j. 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: (i) in response to a qualifying order of a court of competent jurisdiction, or (ii) 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 contracting officer for response. k. 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. INFORMATION SYSTEM HOSTING, OPERATION, MAINTENANCE, OR USE a. 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 HIPAA, 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. b. 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, opera...