PRESOL | Q | MOBILE PET/CT SERVICES

FBO DAILY ISSUE OF SEPTEMBER 19, 2010 FBO #3221
SOLICITATION NOTICE

Q -- MOBILE PET/CT SERVICES

Notice Date: 9/17/2010
Notice Type: Combined Synopsis/Solicitation
NAICS: 621512 — Diagnostic Imaging Centers
Contracting Office: Department of Veterans Affair;VA Ann Arbor Healthcare System;Contracting Office (506/54C);2215 Fuller Road;Ann Arbor MI 48105
ZIP Code: 48105
Solicitation Number: VA25110RQ0355
Response Due: 9/24/2010
Archive Date: 10/24/2010
Point of Contact: Clara Baisden
E-Mail Address: ct
Small Business Set-Aside: N/A
Description: This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in Subpart 12.6, 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. Solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular 05-43. Small business size standard is $11.5 million average annual receipts for the past three years. This procurement is unrestricted. Offerors are encouraged to submit quotes based on the work requirements specified herein for one (1) year from date of award. Proposed rates should include all costs associated with Request For Quote (RFQ) VA-251-10-RQ-0355 and should include the following: Price per scan: includes qualified PET/CT Technologist(s), mobile trailer, all associated equipment, all associated supplies, including but not limited to radioisotopes, and support staff as defined in the specifications. PET/CT scans will be performed during normal working hours (7:00AM-5:30PM). Estimated usage is 500 scans/year. Statement of Work: Contractor will provide all specialized staff, training, supplies, radiopharmaceuticals, and mobile trailer/unit necessary to perform Positron Emission Tomography/Computerized Tomography (PET/CT) services at Veterans Affairs Ann Arbor Healthcare System (VA) in accordance with the Statement of Work. Contractor shall meet all local, state, federal, industry, Joint Commission (JC), Nuclear Regulatory Commission (NRC), National Health Physics Program (NHPP) VA, OSHA, and other regulatory standards. Services shall be provided one day/week. The number of required days/week shall be at the sole discretion of VA. Contractor will be given at least a 14 day notice prior to increasing the number of days the contractor will be on site. Hours of Operation: Contractor personnel shall be performing exams 8 hours/scheduled day, excluding federal holidays, with the first radio-pharmaceutical injection at 7:00 am and the last patient being injected so that the exam is completed NLT 5:30 pm. Contractor and Contracting Officer's Technical Representative (COTR) will mutually agree upon an established schedule (dates and times) for mobile unit and technician to be on station. National Holidays: New Year's Day, Martin Luther King's Birthday, Presidents Day, Memorial Day, Independence Day, Labor Day, Columbus Day, Veterans Day, Thanksgiving, and Christmas, or any day declared by the President to be a national holiday. Off-Duty Hours: 5:31 PM to 6:59 AM. Contractor shall allow adequate time for daily setup as defined in this SOW to assure delivery without delay of services scheduled. Contractor shall contact VA Police at time of arrival in order to access the building and data port connections. Contractor shall contact VA Police at the closing of each day to ensure that both the building and the data port connections are secured. The location and contact numbers for the VA Police will be provided to the contractor by COTR at the post award orientation meeting. Supplies: Contractor shall be solely responsible for the procurement, receipt, dispensing, administration, and safekeeping, of all supplies and medications/drugs required in the performance of the services. Supplies include but are not limited to radioisotopes; to be handled in accordance with contractor's licensing and NRC Regulations. Contractor shall be responsible for proper disposal/removal of all radioactive waste materials from VA site and shall be included in the contract rate. System Capability Requirements: Mobile PET/CT scanner system shall be a full body PET/CT scanner system. Exams to be performed, but are not limited to the following: Oncology related PET/CT exams, Brain imaging with F-18 FDG. Mobile Unit Capabilities shall be maintained with the latest updates/and upgrades for hardware and software necessary for 1) Maintaining compatibility with VA Hospital network 2) Reading PET/CT images at one-site, and 3) Creating, storing, and exporting JPEG and MPEG files for presentations and conference. Mobile unit shall be 1) equipped with a hot lab to receive and store the radioisotope and radioactive waste, 2) able to create, store and export DICOM, JPEG and MPEG file formats, 3) capable of DICOM 3.0 network connection to existing STENTOR iVault PACS system, 4) equipped with CD-R burning capabilities as a backup to network transfer of data, and 5) equipped with an Image Analysis Station. PET/CT trailer shall provide sufficient space and be designed to 1) include a 'quiet room' where the radiopharmaceutical is administered and the patient can rest comfortably with no physical activity and minimum possible external stimuli such as noise and light during the uptake period of the radiopharmaceutical, 2) provide sufficient space for conducting CPR and emergency resuscitation. Mobile Unit Accessories: Accessory equipment to be provided by the contractor: 1) handicap accessible trailer. 2) intercom system between the control room and scanning room. Mobile Unit Equipment Specifications: At a minimum: Contractor will be required to make all necessary adaptations to assure that the contractor's equipment is compatible with the VA Systems. PET/CT 1) images will be of a high resolution diagnostic image quality, 2) must be capable of acquiring images in multiple modes including but not limited to static emission scans and whole body scans, 3) will have a PET detector crystal that has a high light output and short decay constant Lutetium oxyortho-silicate (LSO) in order to shorten PET data acquisition time to the minimum possible (minimum possible what?-define), 4) will be capable of acquiring 2-dimensional and/or 3-dimensional PET images and/or true 3-dimensional images, 5) CT component will have a minimum of a 6-slice detector and will be capable of acquiring the transmission images within one breath hold, 6) CT component will be capable of acquiring data for anatomic localization and attenuation correction, 7) will have attenuation correction algorithm(s) that are designed to use non-contrast enhanced CT data, 8) will have attenuation correction algorithm(s) that are designed to use CT data with oral contrast enhancement, 9) will have attenuation correction algorithm(s) that are designed to use CT data with oral contrast enhancement with negative contrast (water), 10) will be ready for use regardless of outside environmental conditions, 11) will maintain a temperature to assure proper operation of the scanner without frequent calibration and provide for patient comfort. Telecommunications: Mobile PET/CT unit will be equipped with an outlet connection capable of transmitting data and voice through a VA provided CAT five cable. VA will provide the connection required for the transmission of images, data and voice. Contractor's mobile unit must be able to connect to VA VISTA Imaging Network and transmit all images to VISTA Imaging, including compatibility to Dicom 3 imaging standards. A PACS interface contact person will be provided to the successful contractor during the post-award orientation. Mobile unit shall support Dicom Modality Worklist (DMWL) which will allow the technologist to select scheduled patients from a work list generated and displayed on the operational console. At a minimum, study demographics will display facility name, patient name, patient SSN, accession number, procedure, and referring physician. Mobile unit will be able to export DICOM images to multiple destinations concurrently and will be selectable by the operator from a destination list. A PACS interface contact person will be provided by the VA to the successful contractor during the post-award orientation. The system shall conform to all applicable requirements of "Vista DICOM Conformance Requirements for Image Acquisition Modalities in Radiology, Dental, Ophthalmology, and Other Specialties". VA shall provide the following utilities services if necessary for the operation of the mobile unit: water, electricity, telephone line(s), and data port. Telephone access will be provided for calls within VA only. Equipment Maintenance/Repairs: Contractor shall be responsible for all preventive maintenance, emergency repairs, general repairs, safety, cleaning, and upkeep of all equipment furnished by contractor. If the equipment should fail while performing services at VA the contractor will reimburse the VA for all costs incurred by the VA. The contractor's personnel must be present at all times while equipment is on VA premises.VA will not be held responsible for any loss or damage to contractor's property including mobile trailer, while on site. Contractor will maintain property insurance on all equipment throughout the duration of the contract and shall provide proof of insurance prior to award. Contractor Qualifications: Employees proposed to perform services under this contract, shall be licensed or registered in a state, territory or commonwealth of the United States or the District of Columbia. Technologists shall be certified Nuclear Medicine Technologists (ARRT and/or NMTCB). Contractor will provide documentation of training and proof of competency for all technologists in the following areas: PET imaging, Operation of a PET/CT scanner, Intravenous administration of radioisotopes, and administration of intravenous and oral contrast. VA reserves the right to add additional technologists. VA CO will request a written quote from the Contractor. Changes must be executed by a CO prior to commencement of any additional services. Contractor is required to develop and maintain the following documents for each employee: Credentials and qualifications for the job, Current competence assessment checklist to include: 1) An assessment of knowledge, skills, abilities, and behaviors required to perform a job correctly and skillfully 2) An assessment of knowledge and skills required to provide care for certain patient populations as appropriate, 3) A current performance evaluation supporting the ability of the employee to successfully perform the work required, 4) documentation of relevant continuing education for the past two years. Contractor will provide current copies of all records for each contractor employee at the time of contract award and annually on the anniversary date of contract award to the COTR. All personnel assigned to perform the services under this contract will be proficient in written and spoken English and shall be computer literate in the type of software and/or hardware used at VA and shall be required to input documentation directly into the patient's electronic medical record. Mobile unit driver shall be licensed as applicable to operate and drive the mobile vehicle in which unit is housed. Contractor shall provide training for VA technical staff on the full operation of PET/CT unit at no additional cost to VA. Training will include but not be limited to: Study Acquisition Processing and Display, Patient Preparation, Patient Injections, and Technical principles of PET/CT. Contractor will be responsible for providing quality review in order to ensure quality diagnostic images at all sites. The contractor will be responsible for maintaining a daily log of scans performed under contract which will include at a minimum the patient name. The contractor shall continuously meet or exceed all Joint Commission hospital standards. All applicable VA and VHA policies, procedures, and directives shall be followed by the contractor. The patient population treated at the VA, located in Ann Arbor, MI consists of veterans with varying physical, psychiatric, and psychological needs. Their conditions are, in many cases, directly related to the individual's service to this country. Contract personnel shall provide compassionate care with respect for the special needs of the veteran population served. Care delivered will reflect the VA Medical Center's mission, vision and values described as: Mission: Honor America's veterans by providing exceptional health care that improves their health and well-being. Vision: To be a patient centered integrated health care organization for veterans providing excellence in health care, research, and education; an organization where people choose to work; an active community partner and back-up for National emergencies. Patient Rights: All eligible veterans with assessed needs shall be provided primary medical and preventive health care, to include assessment, diagnosis, and treatment. Care provided will respect and integrate the patient's beliefs, values and cultural influences. Contractor shall involve the patient in care decisions by keeping him/her fully informed about the diagnosis, plan of care and treatment goals, risks and benefits of proposed treatment, and prognosis; shared-decision making shall be pursued. Protection of all patients' rights is of highest priority. Patient privacy and confidentiality shall be maintained at all times. Computer access will be granted on a need-to-know basis, and security of computerized information will be maintained at all times. All patient complaints which cannot be resolved by the contractor shall be referred to the VAMC Patient Representative. VA-Contractor and patient care services provided shall be included in VAMC data collection activities related to patient compliments, complaints and satisfaction. Contractor shall fully complete all signed and informed consent documentation within VAMC required timeframes for all invasive procedures, and any non-invasive procedure requiring patient consent. Planned procedures shall not be performed without appropriate pre-procedure consent documentation. No patients shall be subject to any research activity without his fully informed consent, subject to study approval by the Investigational Research Board (IRB). Contractor shall abide by the VAMC Code of Ethics, which addresses marketing, Admission, transfer, referral, discharge processes, and billing issues. Patient Safety: Patient Safety shall be a primary focus of Contractor. This will include compliance with all applicable patient safety goals. Every effort shall be made by the contractor to prevent medication errors, falls, and patient injury caused by acts of commission or omission in the delivery of care. VAMC shall inform contractor of all applicable sentinel event or other patient safety alerts received by VAMC. For every applicable alert, the contractor shall take the necessary steps to redesign processes to prevent occurrence, and provide written feedback to COTR describing prevention actions taken. All events related to patient injury, medication errors, and other breeches of patient safety will be documented utilizing the contractor's format, and reported to COTR verbally and in writing and will be reported to COTR utilizing VAMC Incident Report. VAMC shall provide contractor with VAMC Sentinel Event definitions in the start-up phase. Contractor shall verbally notify VAMC COTR immediately when a Sentinel Event has occurred, which is to be followed by written notification within one business day or sooner if requested by the medical center. VAMC shall determine when a Root Cause Analysis (RCA) is required of contractor. Contractor shall conduct all RCAs according to VAMC policy and within established timeframes (45 days). Completed RCAs shall be provided to VAMC COTR. Patient Assessment: Patient medical history and physical exams appropriate to the care setting shall be performed by the contract staff and documented in accordance with VAMC Bylaws, Rules, Regulations, guiding Medical Center policies, and as clinically indicated by patient signs and symptoms. Assessment for invasive procedures will include all elements as explicitly outlined in VAMC Bylaws and applicable policies. All required documentation shall be fully completed within VAMC required timeframes. Care of Patients: All care shall be provided by licensed, qualified, competent, and appropriately privileged individuals. Competency will be assessed on an annual basis by COTR. VA Credentialing and privileging will be conducted by VAMC. Operative and invasive workload will be reported on a monthly basis to COTR, include confirmation of privileges for procedures performed, complications and adverse outcomes. Medication control, security and safety shall be maintained at all times. No samples shall be provided to any patient. Medications shall only be dispensed, prepared, and administered to patients by appropriately licensed and competent individuals. All findings from patient assessment, reassessment, and treatment provided shall be documented in the medical record, and integrated into the overall plan of care in all care settings across the continuum. Verbal, written or electronic communication between any VAMC/VISN staff and contracted staff shall not be restricted by contractor. Patient Education: Patients will receive interactive education and patient education materials appropriate to the care, treatment or service provided and be documented in the medical record in accordance with VAMC policies and procedures. Performance Improvement: Contractor shall fully participate in the VAMC Performance Improvement (PI) program. Contractor shall maintain a Quality Management Plan consistent with Joint Commission standards. This will entail monitoring of clinic processes, patient outcomes and satisfaction, data analysis and collaborative design and implementation of improvement opportunities. Contractor shall evaluate the quality of PET/CT services and document the findings, conclusions, recommendations, and actions taken. Contractor shall provide a written report to COTR that addresses meeting all Joint Commission standards for improving organizational performance. All quarterly reports will be complied with 3 months of data. The quarters will be based on calendar year (Q1-Jan, Feb, Mar/12-April, May, June/Q3-July, August, September/Q4-October, November, December). The quarterly reporting will include the Performance Improvement Matrix (PIM), and Patient Perception of Care (PCC). Contractor shall collect and aggregate the customer service satisfaction data on service satisfaction from Veterans and their families. Copies of the aggregated data should be forwarded to COTR. Contractor PI activities may be directed by the VAMC, VISN or VHA, as well as accreditation or licensing bodies. Contractor shall abstract, compile and report PI data as requested by the VAMC. VA - Data collection methodology, report format, and reporting deadlines will be defined by the VAMC. In all cases, the contractor shall continually assess for, and act upon, clinical and administrative improvement opportunities. VA - Monitoring for continuous compliance with JOINT COMMISSION standards shall be directed by VAMC staff, and communicated to the contractor through the COTR. VA-Aggregate and/or practitioner-specific data collected by VAMC will be provided to contractor in accordance with established reporting schedules. VA-Measures related to contract compliance will be identified by COTR. Leadership: The provision of contracted services will be described in writing the nature and scope of services provided through contractual agreement. Leaders monitor contracted services by establishing expectations for the performance of the contracted services. Leaders take steps to improve contracted services that do not meet expectations. Environment of Care: Contractor shall maintain a safe environment at all times. Contractor shall successfully pass VAMC Safety and Infection Control inspections prior to the provision of patient care. Routine and recurrent preventive maintenance inspections shall be the responsibility of the contractor. All significant problems identified shall be reported verbally to COTR within 24 hours. A written corrective plan of action shall be submitted to COTR within 5working days. VA - Timeframes and priorities for completion of action plan items will be mutually agreed upon by contractor and VAMC Safety Officer. An annual compliance report addressing preventive maintenance inspections, as well as Safety/Environmental/Infection Control inspections, shall be reported to COTR yearly in March. Human Resources: All contract provided employees such as technologists must be BLS certified. All related documentation, such as completed competency checklists of educational training records, shall be maintained by contractor and available for VAMC review upon request. Contractor shall maintain a culture that promotes self-development and learning, which is designed to maintain or enhance required competencies. Information Management: 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. Access to VA Information and VA Information Systems: 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. 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. 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. Contractor or subcontractor must notify 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. Contracting Officer must also be notified immediately by the contractor or subcontractor prior to an unfriendly termination. VA Information Custodial Language: Information made available to 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 contractor/subcontractor's rights to use data as described in Rights in Data General, FAR 52.227-14(d) (1). 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. 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 VA Contracting Officer within 30 days of termination of the contract. 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. 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 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. If VA determines that 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 contractor or third party or terminate the contract for default or terminate for cause under Federal Acquisition Regulation (FAR) part 12. 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. 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. 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. Except for uses and disclosures of VA information authorized by this contract for performance of the contract, 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. Contractor and 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. 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 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 VA contracting officer for response. 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, contractor/subcontractor must complete a Contractor Security Control Assessment (CSCA) on a yearly basis and provide it to COTR. Information System Hosting Operation, Maintenance, or use: 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. 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 COTR and approvedby 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. 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. Outsourcing (contractor facility, contractor equipment or contractor staff) of systems or network operations, telecommunications services, or other managed services requires certification and accreditation (authorization) (C&A) of the contractor's systems in accordance with VA Handbook 6500.3, Certification and Accreditation and/or the VA OCS Certification Program Office. Government-owned (government facility or government equipment) contractor-operated systems, third party or business partner networks require memorandums of understanding and interconnection agreements (MOU-ISA) which detail what data types are shared, who has access, and the appropriate level of security controls for all systems connected to VA networks. Contractor/subcontractor's system must adhere to all FISMA, FIPS, and NIST standards related to the annual FISMA security controls assessment and review and update the PIA. Any deficiencies noted during this assessment must be provided to the VA contracting officer and the ISO for entry into VA's POA&M management process. Contractor/subcontractor must use VA's POA&M process to document planned remedial actions to address any deficiencies in information security policies, procedures, and practices, and the completion of those activities. Security deficiencies must be corrected within the timeframes approved by the government. Contractor/subcontractor procedures are subject to periodic, unannounced assessments by VA officials, including the VA Office of Inspector General. The physical security aspects associated with contractor/subcontractor activities must also be subject to such assessments. If major changes to the system occur that may affect the privacy or security of the data or the system, the C&A of the system may need to be reviewed, retested and re-authorized per VA Handbook 6500.3. This may require reviewing and updating all of the documentation (PIA, System Security Plan, Contingency Plan). The Certification Program Office can provide guidance on whether a new C&A would be necessary. Contractor/subcontractor must conduct an annual self assessment on all systems and outsourced services as required. Both hard copy and electronic copies of the assessment must be provided to COTR. The government reserves the right to conduct such an assessment using government personnel or another contractor/subcontractor. Contractor/subcontractor must take appropriate and timely action (this can be specified in the contract) to correct or mitigate any weaknesses discovered during such testing, generally at no additional cost. VA prohibits the installation and use of personally-owned or contractor/subcontractor owned equipment or software on VA's network. If non-VA owned equipment must be used to fulfill the requirements of a contract, it must be stated in the service agreement, SOW or contract. All of the security controls required for government furnished equipment (GFE) must be utilized in approved other equipment (OE) and must be funded by the owner of the equipment. All remote systems must be equipped with, and use, a VA-approved antivirus (AV) software and a personal (host-based or enclave based) firewall that is configured with a VA-approved configuration. Software must be kept current, including all critical updates and patches. Owners of approved OE are responsible for providing and maintaining the anti-viral software and the firewall on the non-VA owned OE. All electronic storage media used on non-VA leased or non-VA owned IT equipment that is used to store, process, or access VA information must be handled in adherence with VA Handbook 6500.1, Electronic Media Sanitization upon: (i) completion or termination of the contract or (ii) disposal or return of the IT equipment by contractor/subcontractor or any person acting on behalf of the contractor/ subcontractor, whichever is earlier. Media (hard drives, optical disks, CDs, back-up tapes, etc.) used by contractors/subcontractors that contain VA information must be returned to the VA for sanitization or destruction or contractor/subcontractor must self-certify that the media has been disposed of per 6500.1 requirements. This must be completed within 30 days of termination of the contract. Bio-Medical devices and other equipment or systems containing media (hard drives, optical disks, etc.) with VA sensitive information must not be returned to the vendor at the end of lease, for trade-in, or other purposes. The options are: (1) Vendor must accept the system without the drive; (2) VA's initial medical device purchase includes a spare drive which must be installed in place of the original drive at time of turn-in; or (3) VA must reimburse the company for media at a reasonable open market replacement cost at time of purchase. (4) Due to the highly specialized and sometimes proprietary hardware and software associated with medical equipment/systems, if it is not possible for the VA to retain the hard drive, then; (a) The equipment vendor must have an existing BAA if the device being traded in has sensitive information stored on it and hard drive(s) from the system are being returned physically intact; and (b) Any fixed hard drive on the device must be non-destructively sanitized to the greatest extent possible without negatively impacting system operation. Selective clearing down to patient data folder level is recommended using VA approved and validated overwriting technologies/methods/tools. Applicable media sanitization specifications need to be pre-approved and described in the purchase order or contract. (c) A statement needs to be signed by the Director (System Owner) that states that the drive could not be removed and that (a) and (b) controls above are in place and completed. The ISO needs to maintain the documentation. Security Incident and Investigation: The term "security incident" means an event that has, or could have, resulted in unauthorized access to, loss or damage to VA assets, or sensitive information, or an action that breaches VA security procedures. Contractor/subcontractor shall immediately notify the COTR and simultaneously, the designated ISO and Privacy Officer for the contract of any known or suspected security/privacy incidents, or any unauthorized disclosure of sensitive information, including that contained in system(s) to which the contractor/subcontractor has access. To the extent known by contractor/subcontractor, contractor/subcontractor's notice to VA shall identify the information involved, the circumstances surrounding the incident (including to whom, how, when, and where VA information or assets were placed at risk or compromised), and any other information that contractor/subcontractor considers relevant. With respect to unsecured protected health information, the business associate is deemed to have discovered a data breach when the business associate knew or should have known of a breach of such information. Upon discovery, the business associate must notify the covered entity of the breach. Notifications need to be made in accordance with the executed business associate agreement. In instances of theft or break-in or other criminal activity, contractor/subcontractor must concurrently report the incident to the appropriate law enforcement entity (or entities) of jurisdiction, including VA OIG and Security and Law Enforcement. Contractor, its employees, and its subcontractors and their employees shall cooperate with VA and any law enforcement authority responsible for the investigation and prosecution of any possible criminal law violation(s) associated with any incident. Contractor and subcontractor shall cooperate with VA in any civil litigation to recover VA information, obtain monetary or other compensation from a third party for damages arising from any incident, or obtain injunctive relief against any third party arising from, or related to, the incident. Liquidated Damages For Data Breach: Consistent with the requirements of 38 U.S.C. �5725, a contract may require access to sensitive personal information. If so, the contractor is liable to VA for liquidated damages in the event of a data breach or privacy incident involving any SPI contractor and subcontractor processes or maintains under this contract. Contractor/subcontractor shall provide notice to VA of a "security incident" as set forth in the Security Incident Investigation section above. Upon such notification, VA must secure from a non-Department entity or VA Office of Inspector General an independent risk analysis of the data breach to determine the level of risk associated with the data breach for the potential misuse of any sensitive personal information involved in the data breach. The term 'data breach' means the loss, theft, or other unauthorized access, or any access other than that incidental to the scope of employment, to data containing sensitive personal information, in electronic or printed form, that results in the potential compromise of the confidentiality or integrity of the data. Contractor shall fully cooperate with the entity performing the risk analysis. Failure to cooperate may be deemed a material breach and grounds for contract termination. Each risk analysis shall address all relevant information concerning the data breach, including the following: (1) Nature of the event (loss, theft, unauthorized access); (2) Description of the event, including: (a) date of occurrence ;(b) data elements involved, including any PII, such as full name, social security number, date of birth, home address, account number, disability code; (3) Number of individuals affected or potentially affected; (4) Names of individuals or groups affected or potentially affected; (5) Ease of logical data access to the lost, stolen or improperly accessed data in light of the degree of protection for the data, e.g., unencrypted, plain text; (6) Amount of time the data has been out of VA control; (7) The likelihood that the sensitive personal information will or has been compromised (made accessible to and usable by unauthorized persons); (8) Known misuses of data containing sensitive personal information, if any; (9) Assessment of the potential harm to the affected individuals; (10) Data breach analysis as outlined in 6500.2 Handbook, Management of Security and Privacy Incidents, as appropriate; and (11) Whether credit protection services may assist record subjects in avoiding or mitigating the results of identity theft based on the sensitive personal information that may have been compromised. d. Based on the determinations of the independent risk analysis, the contractor shall be responsible for paying to the VA liquidated damages in the amount of $100, 000 per affected individual to cover the cost of providing credit protection services to affected individuals consisting of the following: (1) Notification; (2) One year of credit monitoring services consisting of automatic daily monitoring of at least 3 relevant credit bureau reports; (3) Data breach analysis; (4) Fraud resolution services, including writing dispute letters, initiating fraud alerts and credit freezes, to assist affected individuals to bring matters to resolution; (5) One year of identity theft insurance with $20,000.00 coverage at $0 deductible; and (6) Necessary legal expenses the subjects may incur to repair falsified or damaged credit records, histories, or financial affairs. 7 Security Controls Compliance Testing on a periodic basis,VA, including the Office of Inspector General, reserves the right to evaluate any or all of the security controls and privacy practices implemented by contractor under the clauses contained within the contract. With 10 working-day's notice, at the request of the government, the contractor must fully cooperate and assist in a government-sponsored security controls assessment at each location wherein VA information is processed or stored, or information systems are developed, operated, maintained, or used on behalf of `VA, including those initiated by Office of Inspector General. The government may conduct a security control assessment on shorter notice (to include unannounced assessments) as determined by VA in the event of a security incident or at any other time. TRAINING: 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: (1) 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; (2) Successfully complete the VA Cyber Security Awareness and Rules of Behavior training and annually complete required security training; (3) Successfully complete the appropriate VA privacy training and annually complete required privacy training; and (4) Successfully complete any additional cyber security or privacy training, as required for VA personnel with equivalent information system access [to be defined by 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.]Contractor shall provide to CO and/or COTR 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. 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 such time as the training and documents are complete. Infection Control: Contracted patient care activities shall be integrated into VAMC Infection Control program, and contract staff shall adhere to VAMC Infection Control policies and procedures. VAMC Infection Control Plan shall identify for the contractor how risks will be identified, methods to be used to reduce risk, identification and reporting of community-acquired and nosocomial infections, and data collection and reporting requirements. Reports of surveillance, control, prevention and monitoring activities performed by the VAMC will be provided, on a routine basis, to contractor. Conflict of Interest: Conflict of Interest acknowledgement document(s) must be signed by all procurement officials and copies filed in the OPF in accordance with VHA Handbook 1660.3. Contracting Officials, COTRs, selection officials, and others involved in the contracting processes are free from any actual or perceived conflicts of interest. CO will monitor compliance and will review the selection board for conflicts. Scheduling of Patient Services: Services shall be scheduled for not less than one daily period of eight (8) hours on every Thursday each week. Scheduling conflicts that cannot be resolved will be decided by CO. The decision of CO will be final in accordance with the disputes provisions of this contract. It is anticipated that the contractor shall be required to confirm the scheduled examinations, including additional visits, by contacting COTR or designee two (2) working days prior to the date of services. Failure to verify scheduled services will not obligate VA for payment if services were not required. Contractor shall establish a firm cut off time for add on exams that will guarantee delivery of the 18-FDG doses if required. Procedures will be established and will be mutually agreed upon between COTR, CO and the successful contractor during the post-award orientation. Cancellations No Charge Services: Contractor will not charge the VA for exams or supplies including unused 18-FDG doses or other radioactive agents when: Exam is cancelled due to patient no show, non-cooperation, or claustrophobia. In the event that the above no-show should occur, the contractor shall not include the cost of the cancelled scan(s) in the monthly invoice. Cancellation of the exam is due to new contraindications for the patient's safety determined on the day of the exam. The quality of the exam is unacceptable as determined by VA physician interpreting the exam Factors include but are not limited to poor positioning and fusion. Contractor will be notified by COTR if any factors contributing to the unacceptability of the exam are found and the contract price shall be adjusted accordingly. Radioactive Materials Handling Requirements: Contractor will procure all radioactive materials (including but not limited to 18F-FDG) under their NRC (Nuclear Regulatory Commission) agreement/state license and shall be ordered directly by contractor. Contractor agrees that if any additional medications/drugs approved by the FDA are required during the performance of services, that VA would have the right to purchase such drugs either from the contractor or from another source and have all medications delivered directly to contractor's trailer during the duration of this contract. Contractor will accept the drugs on behalf of VA under the contractor's current NRC license at no additional cost to VA. If the purchase of additional drugs should occur, the contract will be modified accordingly and an acceptance procedure will be established between VA and the successful contractor regarding delivery, acceptance, and payment. Regardless of the source of purchase the radioactive material will be received by qualified and authorized contractor personnel at contractor's PET/CT trailer. Radioactive waste management will be provided on the Contractor's property, which is PET/CT trailer. E. Unless otherwise defined herein, radioactive administration to patients will be provided on the Contractor's property, which is PET/CT trailer. Radioactive decontamination will be provided by contractor personnel. Storage of such contaminated items will be provided by the contractor. All record keeping requirements regarding the receipt, use, storage and disposition of radioactive material is the responsibility of contractor under contractor's appropriate license. Contractor agrees to ensure that compliance/acceptance testing of PET/CT equipment is performed on at least an annual basis or if major components of the machine is serviced or replaced. The compliance/acceptance tests will be done in accordance with nationally recognized standards (NCRP, AAPM) and JCAHO requirements. Contractor is responsible for ensuring the compliance testing of PET/CT machine will be performed by a qualified medical physicist. A qualified medical physicist as defined is an individual who is certified by the American Board of Radiology in the appropriate disciplines of radiologic physics such as diagnostic radiology for the CT portion of the machine and nuclear medicine for the PET portion of the machine. Contractor is responsible for maintaining all appropriate records and documentation relevant to compliance and performance of the equipment. Contractor's Equipment: Contractor will be responsible for the timely removal of PET/CT trailer from VA premises as agreed upon with the COTR. Removal shall not exceed 24 hours after the completion of the last procedure. Contractor will also be responsible for the following daily exit functions: Ensuring that all of the day's exam data is completely transferred to VA computer system(s) on VA side of the firewall, ensuring that all patient information required for the contractor's records is secured according to HIPPA/VA guidelines, ensuring that all connections from the trailer to VA property are properly disconnected, ensuring that any temporary site preparations are removed upon completion of services on a daily basis, Ensuring that unit, devices, and all necessary accessories, are removed from VA premises, ensuring that the opening from VA trailer access is closed and secured by VA Police. Contractor's vehicle shall be parked and leveled no more than 12" from the existing hospital building. Contractor shall be responsible for leveling of the vehicle at a location designed by the VA. The contractor shall be held responsible for any damages, which may be done to the VA property during hookup and/or removal of equipment at the site. Any damages caused by contractor shall be performed at contractor's expense and to the satisfaction of VA COTR. Proper installation/staging of contractor's furnished equipment including the mobile trailer must be completed in accordance with industry standards, OLSHA regulations and applicable manufacturer recommendations. The installation must be completed prior to commencement of services. The dates and time for completion of the installation shall be mutually agreed upon between the VA and the contractor. ONTRACTOR STAFF QUALIFICATIONS/RESPONSIBILITIES: Contractor will provide the services of two experienced PET/CT technologist(s) to operate the mobile trailer. PET/CT technologists shall be fully trained and qualified according to the qualification standards that have been previously defined in this document. The technologists must be certified by the American Heart Association (AHA) as BCLS, Health Care Provider. Certification must be maintained. The qualifications of such personnel shall also be subject to review by VA Chief of Staff and approval by VA facility Director. VA reserves the right to approve the assignment of individual personnel furnished by contractor to perform the functions specified in the contract. Additional technologists or support staff must be provided if required by workload or by design of the operation. The technologists shall be trained and qualified to perform venipuncture, assess IV patency, and administer the radioisotope according to VA provided procedures and protocols. PET/CT scanning technologists shall be trained and qualified to screen patients using VA questionnaire for potential contraindications to PET/CT imaging, based on VA imaging procedure/protocols. PET/CT scanning technologists shall maintain a log of all VA patients receiving PET/CT scans. Such logs shall be available for inspection by duly authorized representatives of VA upon reasonable notice to the mobile unit's personnel. Inspection shall be during normal working hours of the mobile unit while at VA. Format of log will be in accordance with VA operational practices. PET/CT scanning technologists shall ensure that patient informed consent is obtained and presented prior to performing examinations. PET/CT scanning technologists shall be responsible for screening patients prior to performing PET/CT exams to verify patient identification, pregnancy status, breast-feeding status, and to confirm the procedure to be performed prior to commencement of any services. Disqualification of a patient from the exam must be documented and provided to the designated VA nuclear medicine staff at each visit before the patient leaves PET/CT trailer. Any examination that is unsafe to perform shall be immediately reported to the patient's physician and the VA designated nuclear medicine staff member before the patient leaves PET/CT site. Any side effects that may develop from injection of the radiopharmaceutical or from patient preparation must be reported to the designated nuclear medicine physician immediately upon discovery of the incident. PET/CT technologists is responsible for the initial assessment and identification of medical emergencies and for initiating VA procedure for patients on the mobile unit and for patients in their care. Training for initiating VA procedure for patients on mobile unit will be provided by VA during the initial orientation to the facility and prior to performing exams on patients. PET/CT scanning technologists shall ensure that all PET/CT exams shall be acquired and processed per procedures and protocols provided by the VA Nuclear Medicine physicians. Raw and processed data remain the property of the government. PET/CT scanning technologists shall present each completed PET/CT examination to the designated VA staff physician to review for diagnostic quality. VA nuclear medicine physicians will perform interpretations of the examination(s). Unsatisfactory/non-diagnostic PET/CT examinations shall be re-performed at the discretion of designated nuclear medicine physician at no additional cost to the VA. PET images shall be reconstructed by PET/CT technologists with and without attenuation correction and be available at the time of interpretation. ADDITIONAL REQUIREMENTS FOR CONTRACTOR PERSONNEL AND CONTRACTOR OPERATION; Contractor shall provide VA seven days per week telephone access to mobile PET/CT company used in performance of this contract. Services provided by the contractor shall be performed within the policies, procedures and regulations of VA. Neither contractor nor contract personnel shall in any way undertake the practice of medicine, render medical opinions or services other than those services required to support the well-being of the patient, or in any way with the patient other than to provide all ancillary and technical services required for the operation of PET/CT mobile unit. Contractor shall remove mobile unit from VA premises after the scheduled cases have been completed for each visit unless otherwise agreed upon by the medical center. Contractor shall be JC accredited and shall follow established JC guidelines as they pertain to mobile PET/CT operations. Quality assurance survey reports shall be provided to COTR consistent with Joint Commission recommendations. Contractor shall meet the safety requirements of posting radiation hazardous signs around the mobile unit and make certain the electrical power cable is under a metal cover if it crosses the sidewalk. VA RESPONSIBLITIES: VA shall provide all patient services, with exception of the services provided by Contractor's PET/CT scan technologist as described as the following. (1) Retain full medical responsibility for its patients and their attendance prior to services being performed by the contractor. Contractor shall be responsible for the patient upon pickup at VA designated waiting area, while on the Mobile unit and during the entire scanning procedure, until patient is returned to the designated waiting area. (2) Scheduling of patients for PET/CT exams will be provided by VA. VA will fax a patient list of exams and exam times to contractor in a fashion that is timely and convenient to contractor. Contractor will follow up with phone verification to VA of receipt and acknowledgement of the patient list. (3) Pre-test screening will be provided by VA. Screened patients will be made available to contractor at the specified appointment injection time. (4) VA will be responsible for transporting patients to and from mobile unit. (5) VA shall be responsible for scheduling and handling patient issues that would prevent the patient from being available for the scheduled injection. Scheduling and handling issues will be communicated by VA to the contractor. (6) VA shall ensure each patient arriving for PET/CT scan has a written physician order to receive services and all other forms or information as required. (7) VA will designate in writing one or more VA qualified physicians who will interpret report and take such other steps as may be medically necessary. (8) VA will not be involved in the procurement, management or administration to patients of radioactive material on VA property or under the VA NRC license. PLACE OF INSPECTION AND ACCEPTANCE: Delivery location of PET/CT mobile trailer site shall be coordinated with COTR. Inspection and acceptance of all work performance, reports and other deliverables under this contract shall be performed at the place of delivery. SCOPE OF INSPECTION: Deliverables will be inspected for content, completeness, and accuracy and conformance to contract requirements by COTR or his/her designee. Inspection will include validation of information or software through the use of automated tools and/or testing of the deliverables, as specified in the contract order. The scope and nature of this testing must be negotiated prior to the contract award and will be sufficiently comprehensive to ensure the completeness, quality and adequacy of all deliverables. Reports, documents and narrative type deliverables will only be accepted when all discrepancies, errors or other deficiencies identified in writing by VA have been corrected. Maintenance logs will be available to VA upon request. EMERGENCY REPAIRS: Contractor shall provide at no cost to VA all emergency repairs to include all required personnel, parts and labor, and preventive maintenance/repairs of positron emission tomography (PET/CT) structure and equipment in which to maintain a safe environment as recommended by the original equipment manufacturer (OEM) and the recommendations and specifications in accordance with the agreed upon schedule with COTR. RESPONSE TIME: In the event of an equipment failure during normal working hours while in the performance of contractor's services, contractor shall notify COTR or designee immediately within (define time) after the discovery of equipment failure while on site. Contractor's Field Service Engineer (FSE) must then respond via telephone to the technician within one hour after receipt of telephone notification to the assigned individual. If the problem cannot be corrected by phone or by remote diagnostics within the first hour, the FSE will begin on-site work within two Hours; after it is determined it cannot be resolved via phone. Repairs will proceed progressively to completion. If services are required to be performed on site after the normal working hours the contractor must notify the VA Police that services will be performed on-site. Contractor must also log out with COTR, alternate VA Designee or VA Police upon completion of all services. All emergency repairs are the responsibility of contractor. COTR shall determine if previously scheduled appointments should be cancelled and rescheduled as a result of the equipment failure. In the event that the equipment fails and the failed equipment is un-repairable, contractor must obtain an alternate unit which will be available on the next scheduled Thursday and which meets all of the requirements of the resulting contract to ensure that schedule services will be performed as agreed upon under this agreement. In the event of an equipment failure during the period of time when services were scheduled, the contractor shall be held responsible for all costs associated with the cancellation and/or rescheduling of the patient services. The amount for which contractor is responsible for shall be deducted from contractor's monthly invoice. The provision at 52.212-1, Instructions to Offerors-Commercial (JUN 2008), applies to this acquisition. The provision at 52.212-2, Evaluation - Commercial Items (JAN 1999), applies to this procurement. Offerors are required to submit the following documentation with proposals: Minimum Requirements: Offerors shall submit copy of (1) All licenses and registrations and certifications required by the specifications stated above. (2) Copy of competency assessments for each employee proposed to work on this contract, and (3) Copies of AHA and BCLS certifications. Failure to submit these minimum requirements may result in elimination from consideration for award. The following evaluation factors are listed in descending order of importance, (1) past Performance, (2) Price. Pricing proposals will be ranked in relationship to all other proposals received. Offerors are required to include a completed copy of the provision at 52.212-3, Offeror Representations and Certifications - Commercial Items, (AUG 2009). The clause at 52.212-4, Contract Terms and Conditions - Commercial Items (JUN 2010), applies to this acquisition with the following clauses added as addenda to the clause: 52.204-4 Printing/Copying Double Sided on Recycled Paper (AUG 2000), 52.204-7 Central Contractor Registration (APR 2008), 52.224-1 Privacy Act Notification (APR 1984), 52.224-2 Privacy Act (APR 1984), 852.270-4 Commercial Advertising (NOV 1984), 852.237-70 Contractors Responsibilities (APR 1984), 852.270-1 Representatives of Contracting Officers (JAN 2008), 852.273-75 Security Requirements for Unclassified Information Technology Resources (Oct 2008), 52.217-8 Option to Extend Services (NOV 1999), 52.217-9 Option to Extend Term of Contract (MAR 2000). The clause at 52.212-5, Contract Terms and Conditions Required To Implement Statutes or Executive Orders - Commercial Items (JUL 2010), applies to this acquisition and the additional FAR clauses cited in the clause are: 52.219-8, Utilization of Small Business Concerns (MAY 2004) (15 U.S.C. 637 (d)(2) and (3)), 52.222-21, Prohibition of Segregated Facilities (FEB 1999), 52.222-26, Equal Opportunity (MAR 2007)(E.O. 11246), 52.222-35, Affirmative Action for Disabled Veterans and Veterans of the Vietnam Era (SEP 2006)(29 U.S.C. 793), 52.222-36, Affirmative Action for Workers with Disabilities (JUN 1998) (29 U.S.C. 793), 52.222-37, Employment Reports on Disabled Veterans and Veterans of the Vietnam Era (SEP 2006)(38 U.S.C. 4212), 52.216-18, Ordering Limitation (OCT 1995), 52.216-19, Order Limitations (OCT 1995), 52.228-5, Insurance - Work on a Government Installation (JAN 1997), 52.232-19, Availability of Funds for the Next Fiscal Year (APR 1984), 852.237-7, Indemnification and Medical Liability Insurance (JAN 2008), 852.203-70, Commercial Advertising (JAN 2008), 852.273-75, Security Requirements for Unclassified Information Technology Resources (Interim - October 2008), 852.273-76, Electronic Invoice Submission (Interim - October 2008). Offerors may submit proposals on offerors letterhead. Successful offeror shall be required to sign a SF1449 prior to award.
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Place of Performance: Address: VA Ann Arbor Healthcare System;2215 Fuller Road;Ann Arbor, MI; Zip Code: 48105
Record: SN02286489-W 20100919/100917235253-d106d2074e3e51288ee587dd3de45460 (fbodaily.com)
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Q -- MOBILE PET/CT SERVICES