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FBO DAILY - FEDBIZOPPS ISSUE OF JULY 25, 2018 FBO #6088
DOCUMENT

Q -- 678-19-1-047-0006 Holter Monitoring (VA-18-00085602) (VA-18-00095680) - Attachment

Notice Date

7/23/2018
 

Notice Type

Attachment
 

NAICS

621511 — Medical Laboratories
 

Contracting Office

Department of Veterans Affairs;NCO22-Gilbert Network Contracting;3601 S. 6th Avenue;Tucson AZ 85723
 

ZIP Code

85723
 

Solicitation Number

36C25818Q9662
 

Response Due

7/31/2018
 

Archive Date

10/29/2018
 

Point of Contact

Anne Miller
 

E-Mail Address

iller@va.gov<br
 

Small Business Set-Aside

N/A
 

Description

This is a SOURCES SOUGHT ANNOUNCEMENT ONLY. It is neither a solicitation announcement nor a request for proposals or quotes and does not obligate the Government to award a contract. Requests for a solicitation will not receive a response. Responses to this sources sought must be in writing. The purpose of this sources sought announcement is for market research to make appropriate acquisition decisions and to gain knowledge of potential qualified Service Disabled Veteran Owned Small Businesses, Veteran Owned Small Businesses, 8(a), HubZone, other Small and Large Businesses interested and capable of providing the services described below. Documentation of technical expertise must be presented in sufficient detail for the Government to determine that your company possesses the necessary functional area expertise and experience to compete for this acquisition. Responses to this notice shall include the following: (a) company name (b) address (c) point of contact (d) phone, fax, and email of point of contact (e) DUNS number (f) Cage Code (g) Tax ID Number (h) If respondent is VOSB or SDVOSB, respondent is to provide proof of www.vetbiz.gov certification. In addition, SDVOSB/VOSB Contractors are asked to acknowledge that they understand the limitations on sub-contracting pursuant to FAR 52.219-14, Limitations on Sub-Contracting, which will be included in the impending solicitation. Furthermore SDVOSB/VOSB contractors are asked to respond that they are capable of providing the requested services keeping within the parameters of this clause. (i)If an Offeror proposes to use any subcontractors, joint ventures, or teaming arrangements the Offeror shall include the percentage and type of work the subcontractor will accomplish to include their certifications. (Any subcontractors, joint ventures, or teaming partners shall have the required certifications as described in the sources sought notice) and (j) must provide a capability statement that addresses the organizations qualifications and ability to perform as a contractor for the work described below. DRAFT STATEMENT OF WORK Ambulatory Cardiac Monitoring Services for the Southern Arizona VA Health Care System (SAVAHCS) Part 1 General Information GENERAL: This is a non-personnel services contract to provide ambulatory cardiac monitoring services. The Government shall not exercise any supervision or control over the contract service providers performing the services herein. Such contract service providers shall be accountable solely to the Contractor who, in turn is responsible to the Government. Description of Services/Introduction: The contractor shall provide all personnel, equipment, supplies, facilities, transportation, tools, materials, supervision, and other items and non-personal services necessary to perform ambulatory cardiac monitoring services as defined in this Performance Work Statement except for those items specified as government furnished property and services. The contractor shall perform to the standards in this contract. Background: Due to a lack of internal resources, SAVAHCS will continue to contract out its requirements for ambulatory cardiac monitoring services in order to serve the veteran patients. Ambulatory cardiac monitoring services are a necessary component of a full service cardiology program and necessary to the provision of quality care to veterans. This service allows the ability to make timely diagnosis of disorders related to cardiac rhythms. While patients are performing routine daily activities, the chances of documenting arrhythmias causing transient problems are greatly enhanced through the use of monitoring. At the onset of a symptom (flutters, dizziness, presyncopal episodes, etc.), monitoring allows for the detection of symptomatic and asymptomatic cardiac rhythm disturbances. Objectives: The objective of this contract is to provide three levels of ambulatory cardiac monitoring services for patients of SAVAHCS so that appropriate treatment may be provided to veteran patients who are determined to need an analysis of their heart. The three levels of service are: cardiac ambulatory telemetry, holter monitoring and cardiac event monitoring. Each of these levels of service are further described in the Part 5, Specific Tasks, of this PWS. Scope: Services include ambulatory cardiac monitoring services, to include providing instruction and guidance to patients and results reporting to SAVAHCS staff so that appropriate treatment of the patient may be pursued. Period of Performance: The period of performance shall be for one (1) Base Period of approximately 12 months and four (4) 12-month option years. The Period of Performance reads as follows: Base Period - November 1, 2018 through October 31, 2019 Option Year I - November 1, 2019 through October 31, 2020 Option Year II - November 1, 2020 through October 31, 2021 Option Year III - November 1, 2021 through October 31, 2022 Option Year IV - November 1, 2022 through October 31, 2023 General Information Quality Control: The contractor shall develop and maintain an effective quality control program to ensure services are performed in accordance with this PWS. The contractor shall develop and implement procedures to identify, prevent, and ensure non-recurrence of defective services. The contractor s quality control program is the means by which he assures himself that his work complies with the requirement of the contract. The contractor shall deliver a Quality Control Plan as part of its proposal submission. After acceptance of the quality control plan the contractor shall receive the contracting officer s acceptance in writing of any proposed change to his QC system. Quality Assurance: The government shall evaluate the contractor s performance under this contract in accordance with the Quality Assurance Surveillance Plan. This plan is primarily focused on what the Government must do to ensure that the contractor has performed in accordance with the performance standards. It defines how the performance standards will be applied, the frequency of surveillance, and the minimum acceptable defect rate(s). Recognized Holidays: The contractor shall provide services under this contract 365 days/year, 24 hours/day. There is no recognition of Federal holidays under this contract; however, the Government facility recognizes the Federal holidays listed below. During non-business hours and holidays the contractor may experience a delay in reaching physicians and nurses at the facility; however, Government physicians/nurses will be on call during these times. New Year s Day Labor Day Martin Luther King Jr. s Birthday Columbus Day President s Day Veteran s Day Memorial Day Thanksgiving Day Independence Day Christmas Day Hours of Operation: The contractor is responsible for conducting business, 365 days/year, 24 hours/day. The main business hours of the Government s facility are 8:00AM to 4:30PM Monday thru Friday except Federal holidays or when the Government facility is closed due to local or national emergencies, administrative closings, or similar Government directed facility closings. For other than firm fixed price contracts, the contractor will not be reimbursed when the government facility is closed for the above reasons. The Contractor must at all times maintain an adequate workforce for the uninterrupted performance of all tasks defined within this PWS when the Government facility is not closed for the above reasons. When hiring personnel, the Contractor shall keep in mind that the stability and continuity of the workforce are essential. Place of Performance: The work to be performed under this contract will be performed at the contractor s facility(ies). Type of Contract: The government will award a Indefinite Delivery Indefinite Quantity (IDIQ) firm fixed price line item contract. Security Requirements: The contractor shall maintain the security and integrity of patient information in accordance with all applicable Federal, State, Local and VA regulations, guides and directives. Violation of patient confidentiality may result in contract termination. HIPPA training is required for all contractor employees supporting this contract. 1.6.7.1 PHYSICAL Security: The contractor shall be responsible for safeguarding all government equipment, information and property provided for contractor use. Special Qualifications: All technicians performing services under this contract shall be certified by Cardiovascular Credentialing International as Certified Cardiac Technicians. Post Award Conference/Periodic Progress Meetings: The Contractor agrees to attend any post award conference convened by the contracting activity or contract administration office in accordance with Federal Acquisition Regulation Subpart 42.5. The contracting officer, Contracting Officers Representative (COR), and other Government personnel, as appropriate, may meet periodically with the contractor to review the contractor's performance. At these meetings the contracting officer will apprise the contractor of how the government views the contractor's performance and the contractor will apprise the Government of problems, if any, being experienced. Appropriate action shall be taken to resolve outstanding issues. These meetings shall be at no additional cost to the government. Contracting Officer Representative (COR): The (COR) will be identified by separate letter. The COR monitors all technical aspects of the contract and assists in contract administration The COR is authorized to perform the following functions: assure that the Contractor performs the technical requirements of the contract: perform inspections necessary in connection with contract performance: maintain written and oral communications with the Contractor concerning technical aspects of the contract: issue written interpretations of technical requirements, including Government drawings, designs, specifications: monitor Contractor's performance and notifies both the Contracting Officer and Contractor of any deficiencies; coordinate availability of government furnished property, and provide site entry of Contractor personnel. A letter of designation issued to the COR, a copy of which is sent to the Contractor, states the responsibilities and limitations of the COR, especially with regard to changes in cost or price, estimates or changes in delivery dates. The COR is not authorized to change any of the terms and conditions of the resulting order. Identification of Contractor Employees: All contract personnel attending meetings, answering Government telephones, and working in other situations where their contractor status is not obvious to third parties are required to identify themselves as such to avoid creating an impression in the minds of members of the public that they are Government officials. They must also ensure that all documents or reports produced by contractors are suitably marked as contractor products or that contractor participation is appropriately disclosed. Data Rights: The Government has unlimited rights to all documents/material produced under this contract. All documents and materials, to include the source codes of any software, produced under this contract shall be Government owned and are the property of the Government with all rights and privileges of ownership/copyright belonging exclusively to the Government. These documents and materials may not be used or sold by the contractor without written permission from the Contracting Officer. All materials supplied to the Government shall be the sole property of the Government and may not be used for any other purpose. This right does not abrogate any other Government rights. PART 2 DEFINITIONS & ACRONYMS DEFINITIONS AND ACRONYMS: DEFINITIONS: CONTRACTOR. A supplier or vendor awarded a contract to provide specific supplies or service to the government. The term used in this contract refers to the prime. CONTRACTING OFFICER. A person with authority to enter into, administer, and or terminate contracts, and make related determinations and findings on behalf of the government. Note: The only individual who can legally bind the government. CONTRACTING OFFICER'S REPRESENTATIVE (COR). An employee of the U.S. Government appointed by the contracting officer to administer the contract. Such appointment shall be in writing and shall state the scope of authority and limitations. This individual has authority to provide technical direction to the Contractor as long as that direction is within the scope of the contract, does not constitute a change, and has no funding implications. This individual does NOT have authority to change the terms and conditions of the contract. DEFECTIVE SERVICE. A service output that does not meet the standard of performance associated with the Performance Work Statement. DELIVERABLE. Anything that can be physically delivered, but may include non-manufactured things such as meeting minutes or reports. KEY PERSONNEL. Contractor personnel that are evaluated in a source selection process and that may be required to be used in the performance of a contract by the Key Personnel listed in the PWS. When key personnel are used as an evaluation factor in best value procurement, an offer can be rejected if it does not have a firm commitment from the persons that are listed in the proposal. PHYSICAL SECURITY. Actions that prevent the loss or damage of Government property. QUALITY ASSURANCE. The government procedures to verify that services being performed by the Contractor are performed according to acceptable standards. QUALITY ASSURANCE Surveillance Plan (QASP). An organized written document specifying the surveillance methodology to be used for surveillance of contractor performance. QUALITY CONTROL. All necessary measures taken by the Contractor to assure that the quality of an end product or service shall meet contract requirements. SUBCONTRACTOR. One that enters into a contract with a prime contractor. The Government does not have privity of contract with the subcontractor. WORK DAY. The number of hours per day the Contractor provides services in accordance with the contract. 2.1.12. WORK WEEK. Monday through Friday, unless specified otherwise. 2.2. ACRONYMS: CFR Code of Federal Regulations COR Contracting Officer Representative COTS Commercial-Off-the-Shelf FAR Federal Acquisition Regulation HIPAA Health Insurance Portability and Accountability Act of 1996 KO Contracting Officer OCI Organizational Conflict of Interest POC Point of Contact PRS Performance Requirements Summary PWS Performance Work Statement QA Quality Assurance QAP Quality Assurance Program QASP Quality Assurance Surveillance Plan QC Quality Control QCP Quality Control Program TE Technical Exhibit PART 3 GOVERNMENT FURNISHED PROPERTY, EQUIPMENT, AND SERVICES GOVERNMENT FURNISHED ITEMS AND SERVICES: Services: The Government will provide the following relative to the 3 types of service under this contract: Cardiac Event Monitoring: The Government will provide the patient s name and address to the contractor so that equipment may be shipped to the patient. No sensitive patient information, such as social security number or birth date, will be provided. Holter Monitoring: The Government will affix the contractor provided equipment to the patient and will remove the equipment from the patient. Also, the Government will upload the data from the contractor provided equipment to the contractor s website. Pseudonyms will be used to identify patients. No sensitive patient information will be provided. Ambulatory Cardiac Monitoring: Depending on the solution offered by the contractor, the Government will either provide services similar to the ones described for cardiac event monitoring above or holter monitoring as described above. PART 4 CONTRACTOR FURNISHED ITEMS AND SERVICES CONTRACTOR FURNISHED ITEMS AND RESPONSIBILITIES: General: The Contractor shall furnish all supplies, equipment, facilities and services required to perform work under this contract that are not listed under Section 3 of this PWS. The contractor shall be responsible for establishment, maintenance and all costs associated with toll-free lines, computer related operations, and all necessary shipping fees required for performance of this service. Materials. The Contractor shall provide all materials, e.g., batteries, required to support monitoring devices. Equipment.. The Contractor shall provide all monitoring devices required to perform the services under this contract. PART 5 SPECIFIC TASKS Specific Tasks: Basic Services. The contractor shall provide ambulatory cardiac monitoring services for the Southern Arizona VA Health Care System, to include a principal facility in Tucson, AZ and seven (7) community based outreach clinics (CBOCs) with Southern Arizona. There are three levels of service required: cardiac event monitoring, holter monitoring and ambulatory cardiac telemetry. The contractor shall provide all devices required for monitoring to include shipping of the monitoring device to the patient and providing a postage paid envelope in which to return the device to the contractor. The contractor shall provide analysis of transmissions to include an overread by a physician. SAVAHCS has a preference for a monitoring device that wirelessly transmits data in real time to the contractor. If a wireless device is not offered, the contractor s proposed solution shall be compatible with cellular devices for transmission of data. The contractor shall also provide a secure web based interface for uploading and downloading patient data. The web based interface shall include a reporting tool which provides patient results data within 1 business day for non-emergent data and within 1 hour for emergent situations of the transmission from the device. Thresholds for emergent situation will be determined at the kick off meeting following contract award. The reporting tool shall provide canned reports as well as the ability for Government users to develop customized reports in real time. Both canned and custom reports must be downloadable into a format such as.xls,.csv,.txt, etc. At a minimum, the reporting tool shall offer the following fields that may be used to create a customized report: patient name, date of service, date and time of event, status (e.g., active, pending, enrolled), and shall present a high quality signal transmission. Patient data transmissions shall remain available on the website for a period of twelve months (either actively or via archive) following the completion of the patient s monitoring. The contractor shall provide a backup, e.g., facsimile, to its web based interface. The contractor shall have an adequate backup system in place to maintain satisfactory coverage in the event of a primary system failure. In the case of scheduled downtime, the contractor shall notify the COR or the COR s designee at least 72 hours in advance of the date and estimated period of downtime. The contractor shall perform the functions required in this statement of work in accordance with the rules of medical ethics, Federal, State and local laws, rules and regulations. The contractor will not participate in, nor be a party to, any activities which are in conflict with Federal and/or State guidelines. In the event the contractor encounters conflicting situations, the contractor shall notify the COR, the COR s designee, or the Contracting Officer to resolve such issues. The Contracting Officer will document the file and refer the matter to the local Privacy Officer for resolution of any such situations. If the patient or Government loses or destroys a device, the contractor shall replace the device at no charge for up to 2% of the total device usage per contract year. For example, if the Government uses a cumulative of 500 instances of the service CLINs for the 3 varieties of monitoring during a contract year, losses/damage of up to 10 devices is permitted at no cost to the Government. If the losses exceed 2% per contract year, the contractor shall be reimbursed for its replacement cost of the device as defined in the Price Schedule. Normal wear and tear that leads to destruction of the device shall not be counted as a loss or destruction for the purpose of the 2% losses permitted per contract year. Cardiac Event Monitoring Cardiac event monitoring is a continuous loop, digital memory recorder worn for extended periods of time (up to 30 days or more) that can record transient events felt by the patient at any time. Because of the transient and infrequent nature of these symptoms, this is the acceptable tool for documenting arrhythmias that are missed on a 24-hour holter monitor. Event monitoring services include a 14-30 day period and require the contractor to monitor services by a team of certified cardiology technicians staffing their respective laboratory 24 hours/day, 365 days/year. Upon enrollment of a patient for cardiac event monitoring services, the contractor shall ship a cardiac event recorder directly to the patient s home address. Each recorder shall come complete with enough electrodes, batteries, and other consumable items to allow the patient to use the device for up to 30 days. A pre-paid shipping envelope shall be included so that the patient can return the event recorder directly to the contractor at the conclusion of the monitoring period. Contractor staff shall instruct the patient via the telephone on how to wear the monitor and record their ECG when they experience symptoms such as palpitations or dizzy spells. During the monitoring period patients shall be able to call the contractor on a toll-free number after they have felt a symptom and recorded an ECG. The contractor s cardiac technicians shall ask the patient to describe their symptoms, what they were doing when the experienced the symptoms, and then ask them to transmit the ECG from the event recorder (if it has not already been transmitted wirelessly without action by the patient). Contractor personnel shall be sufficiently familiar with the operation of their specific event recorders, and help patients on how to make the transmission. Once the transmission has been received, technicians will prepare a report to be delivered to the referring physician via the web based reporting tool. If the transmitted ECG demonstrates an abnormal rhythm that fits pre-established notification criteria (the parameters will be defined and agreed upon at the kick off meeting following contract award), a SAVAHCS physician shall be contacted immediately by contractor personnel. These notification criteria may be established individually per customer or per physician preference. Holter Monitoring Holter monitoring is sometimes called continuous EKGs (electrocardiograms) and is based on a 24 or 48 hour time period used for monitoring a patient s heart rhythm. The holter monitor is a small device patch style device that is affixed to the patient s chest with a water resistant, self-adhesive patch. These sensors detect and record the heart s electrical signals. The data recorded on the holter monitor shall be transmitted to the contractor provided system so that data is available for display via the web based reporting tool. Company to supply to the patient a prepaid postage stamped envelope or box to send the monitor back to the company when monitoring is completed. The contractor s laboratory technicians shall analyze each recording using its tools and present the data via the web based reporting tool within 24 hours of receipt of the data at the contractor s facility. The contractor shall provide 15 holter monitoring devices along with consumable supplies to SAVAHCS within 5 business days following contract award. If a of the holter monitoring devices is lost or damaged, the contractor shall replace the device within 5 business days of being notified by SAVAHCS of the need for a replacement. The Government will return any damaged devices to the contractor. Ambulatory Cardiac Telemetry Ambulatory cardiac telemetry (ACT) is an automatically activated system that requires no patient intervention to either capture or transmit arrhythmia when it occurs. Upon detection, the system automatically wirelessly transmits the ECG waveform to the contractor for analysis. This type of service will be used for patients who are symptomatic and require continuous monitoring for a period of approximately 2 weeks to 30 days. For patients that live in rural areas and out of the country, the patch type monitor will be provided. Company to supply to the patient a prepaid postage stamped envelope or box to send the monitor back to the company when monitoring is completed. The contractor s proposed solution for this type of service will determine how it is administered, either similar to the cardiac event monitoring or holter monitoring. If the devices are of one use/patient variety, the contractor shall provide an initial quantity of 30 devices to SAVAHCS within 5 business days following contract award. QUALITY ASSURANCE SURVEILLANCE PLAN The contractor service requirements are summarized into performance objectives that relate directly to mission essential items. The performance threshold briefly describes the minimum acceptable levels of service required for each requirement. These thresholds are critical to mission success. Performance Objective (The Service required usually a shall statement) Standard PERFORMANCE THRESHOLD (THIS IS THE MAXIMUM ERROR RATE. IT COULD POSSIBLY BE ZERO DEVIATION FROM STANDARD ) Method of Surveillance PRS # 1. The contractor shall provide timely delivery of monitoring devices to patients. The contractor provided monitoring devices shall be delivered to patients within 5 business days of notification by SAVAHCS. 100% Random sampling PRS # 2 The contractor shall provide timely posting of monitoring results to the web based reporting tool. Monitoring results shall be posted to the web based reporting tool within 1 business day of collection of the information from the device. 98% Random sampling PRS # 3 The contractor shall provide a stable web based reporting tool. The contractor s web based reporting tool shall be available 365 days/year, 24 hours/day. 99% up time each month Documentation of outages PRS # 4 The contractor shall provide certified cardiac technologists. The contractor shall provide copies of certifications for cardiac technologists as may be requested by the COR. 99% Random sampling/inspe ction. PRS # 5 The contractor shall provide prompt notification of a life threatening event related to a SAVAHCS patient. The contractor shall immediately call 911 in the event of a life threatening event. The contractor shall also contact SAVAHCS on call Fellow within 1 hour of the life threatening event. 100% Random sampling/revie w of reports monthly PRS # 6 The contractor shall provide timely and accurate invoices. Invoices shall be accurate and delivered by the 15th calendar day of the month following the month that is being invoiced (e.g., for services provided March 1-31, 2013, an invoice shall be delivered by April 15, 2013. 95% 100% inspection DELIVERABLES SCHEDULE DELIVERABLE FREQUENCY # OF COPIES MEDIUM/FORMAT SUBMIT TO Monitoring Results for Individual Patients As required, by patient 1 Web based reporting tool that allows for download of data (or fax backup when web based tool is unavailable) Web based reporting tool Monitoring Devices As required, by patient 1 Mail appropriate device for type of monitoring required Patient Certifications for Certified Cardiac Technologists A requested as part or random inspection (not to exceed 2/month) 1 Email COR Invoices Monthly 2 Email/Fax COR VAS FSC Austin Quality Control Plan With proposal and updated as changes are made 2 Email Contracting Officer COR ESTIMATED WORKLOAD DATA ITEM NAME ANNUAL QUANTITY 1 Cardiac Event 54 Monitoring instances/patient s 2 Holter Monitoring 207 Monitoring instances/patient s 2 Ambulatory Cardiac Monitoring 200 Monitoring instances/patient s Note: There is no historical information for cardiac ambulatory telemetry as this service is not offered under the current contract. DELIVERABLE SPECIFICATIONS Web Based Reporting Tool At a minimum, the required web based reporting tool shall offer the following fields of data: Patient name, date of service, date and time of event, status (e.g., active, pending, enrolled), and shall present a high quality signal transmission. Invoices At a minimum, invoices shall contain the following information: Contractor Name Contractor Contact Information Contract Number Date of Order Name of Government personnel that placed order Date and Time of Delivery Price Schedule Item Number Description Quantity Unit Price Extended Price (Quantity x Unit Price) IT CONTRACT SECURITY VA INFORMATION AND INFORMATION SYSTEM SECURITY/PRIVACY 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 thesepolicies 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. 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. VA INFORMATION CUSTODIAL LANGUAGE 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). 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 the VA Contracting Officer within 30 days of termination of the contract. 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. 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. \ 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. 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. The contractor/subcontractor must store, transport, or transmit VA sensitive information in an encrypted form, using VA-approved encryption tools that are, at a minimum, FIPS 140-2 validated. The contractor/subcontractor's firewall and Web services security controls, if applicable, shall meet or exceed VA's minimum requirements. VA Configuration Guidelines are available upon request. 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. Notwithstanding the provision above, the contractor/subcontractor shall not release VA records protected by Title 38 U.S.C. 5705, confidentiality of medical quality assurance records and/or Title 38 U.S.C. 7332, confidentiality of certain health records pertaining to drug addiction, sickle cell anemia, alcoholism or alcohol abuse, or infection with human immunodeficiency virus. If the contractor/subcontractor is in receipt of a court order or other requests for the above mentioned information, that contractor/subcontractor shall immediately refer such court orders or other requests to the VA contracting officer for response. 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 DESIGN AND DEVELOPMENT Information systems that are designed or developed for or on behalf of VA at non-VA facilities shall comply with all VA directives developed in accordance with FISMA, HIPAA, NIST, and related VA security and privacy control requirements for Federal information systems. This includes standards for the protection of electronic PHI, outlined in 45 C.F.R. Part 164, Subpart C, information and system security categorization level designations in accordance with FIPS 199 and FIPS 200 with implementation of all baseline security controls commensurate with the FIPS 199 system security categorization (reference Appendix D of VA Handbook 6500, VA Information Security Program). During the development cycle a Privacy Impact Assessment (PIA) must be completed, provided to the COR, and approved by the VA Privacy Service in accordance with Directive 6507, VA Privacy Impact Assessment. The contractor/subcontractor shall certify to the COR that applications are fully functional and operate correctly as intended on systems using the VA Federal Desktop Core Configuration (FDCC), and the common security configuration guidelines provided by NIST or the VA. This includes Internet Explorer 7 configured to operate on Windows XP and Vista (in Protected Mode on Vista) and future versions, as required. The standard installation, operation, maintenance, updating, and patching of software shall not alter the configuration settings from the VA approved and FDCC configuration. Information technology staff must also use the Windows Installer Service for installation to the default "program files" directory and silently install and uninstall. Applications designed for normal end users shall run in the standard user context without elevated system administration privileges. The security controls must be designed, developed, approved by VA, and implemented in accordance with the provisions of VA security system development life cycle as outlined in NIST Special Publication 800-37, Guide for Applying the Risk Management Framework to Federal Information Systems, VA Handbook 6500, Information Security Program and VA Handbook 6500.5, Incorporating Security and Privacy in System Development Lifecycle. The contractor/subcontractor is required to design, develop, or operate a System of Records Notice (SOR) on individuals to accomplish an agency function subject to the Privacy Act of 1974, (as amended), Public Law 93-579, December 31, 1974 (5 U.S.C. 552a) and applicable agency regulations. Violation of the Privacy Act may involve the imposition of criminal and civil penalties. The contractor/subcontractor agrees to: Comply with the Privacy Act of 1974 (the Act) and the agency rules and regulations issued under the Act in the design, development, or operation of any system of records on individuals to accomplish an agency function when the contract specifically identifies: The Systems of Records (SOR); and The design, development, or operation work that the contractor/ subcontractor is to perform; Include the Privacy Act notification contained in this contract in every solicitation and resulting subcontract and in every subcontract awarded without a solicitation, when the work statement in the proposed subcontract requires the redesign, development, or operation of a SOR on individuals that is subject to the Privacy Act; and Include this Privacy Act clause, including this subparagraph (3), in all subcontracts awarded under this contract which requires the design, development, or operation of such a SOR. In the event of violations of the Act, a civil action may be brought against the agency involved when the violation concerns the design, development, or operation of a SOR on individuals to accomplish an agency function, and criminal penalties may be imposed upon the officers or employees of the agency when the violation concerns the operation of a SOR on individuals to accomplish an agency function. For purposes of the Act, when the contract is for the operation of a SOR on individuals to accomplish an agency function, the contractor/subcontractor is considered to be an employee of the agency. "Operation of a System of Records" means performance of any of the activities associated with maintaining the SOR, including the collection, use, maintenance, and dissemination of records. "Record" means any item, collection, or grouping of information about an individual that is maintained by an agency, including, but not limited to, education, financial transactions, medical history, and criminal or employment history and contains the person's name, or identifying number, symbol, or any other identifying particular assigned to the individual, such as a fingerprint or voiceprint, or a photograph. "System of Records" means a group of any records under the control of any agency from which information is retrieved by the name of the individual or by some identifying number, symbol, or other identifying particular assigned to the individual. The vendor shall ensure the security of all procured or developed systems and technologies, including their subcomponents (hereinafter referred to as "Systems"), throughout the life of this contract and any extension, warranty, or maintenance periods. This includes, but is not limited to workarounds, patches, hotfixes, upgrades, and any physical components (hereafter referred to as Security Fixes) which may be necessary to fix all security vulnerabilities published or known to the vendor anywhere in the Systems, including Operating Systems and firmware. The vendor shall ensure that Security Fixes shall not negatively impact the Systems. The vendor shall notify VA within 24 hours of the discovery or disclosure of successful exploits of the vulnerability which can compromise the security of the Systems (including the confidentiality or integrity of its data and operations, or the availability of the system). Such issues shall be remediated as quickly as is practical, but in no event longer than 5 days. When the Security Fixes involve installing third party patches (such as Microsoft OS patches or Adobe Acrobat), the vendor will provide written notice to the VA that the patch has been validated as not affecting the Systems within 10 working days. When the vendor is responsible for operations or maintenance of the Systems, they shall apply the Security Fixes within 10 days. All other vulnerabilities shall be remediated as specified in this paragraph in a timely manner based on risk, but within 60 days of discovery or disclosure. Exceptions to this paragraph (e.g. for the convenience of VA) shall only be granted with approval of the contracting officer and the VA Assistant Secretary for Office of Information and Technology. 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 vulnerablity 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. 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. The 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. The 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. The 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 the COR. The government reserves the right to conduct such an assessment using government personnel or another contractor/subcontractor. The 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 the 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 the contractors/ subcontractors that contain VA information must be returned to the VA for sanitization or destruction or the 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: Vendor must accept the system without the drive; 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 VA must reimburse the company for media at a reasonable open market replacement cost at time of purchase. 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; 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 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. 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 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. The contractor/ subcontractor shall immediately notify the COR 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 the contractor/subcontractor, the contractor/ subcontractor's notice to VA shall identify the information involved, the circumstances surrounding the incident (including to whom, how, when, and where the VA information or assets were placed at risk or compromised), and any other information that the 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, the contractor/subcontractor must concurrently report the incident to the appropriate law enforcement entity (or entities) of jurisdiction, including the VA OIG and Security and Law Enforcement. The 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. The contractor/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 the contractor/subcontractor processes or maintains under this contract. The 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 the 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: Nature of the event (loss, theft, unauthorized access); Description of the event, including: date of occurrence; data elements involved, including any PII, such as full name, social security number, date of birth, home address, account number, disability code; Number of individuals affected or potentially affected; Names of individuals or groups affected or potentially affected; 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; Amount of time the data has been out of VA control; The likelihood that the sensitive personal information will or has been compromised (made accessible to and usable by unauthorized persons); Known misuses of data containing sensitive personal information, if any; Assessment of the potential harm to the affected individuals; Data breach analysis as outlined in 6500.2 Handbook, Management of Security and Privacy Incidents, as appropriate; and 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. 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 $37.50 per affected individual to cover the cost of providing credit protection services to affected individuals consisting of the following: Notification; One year of credit monitoring services consisting of automatic daily monitoring of at least 3 relevant credit bureau reports; Data breach analysis; Fraud resolution services, including writing dispute letters, initiating fraud alerts and credit freezes, to assist affected individuals to bring matters to resolution; One year of identity theft insurance with $20,000.00 coverage at $0 deductible; and Necessary legal expenses the subjects may incur to repair falsified or damaged credit records, histories, or financial affairs. 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 the 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 the 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: 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; Successfully complete the VA Cyber Security Awareness and Rules of Behavior training and annually complete required security training; Successfully complete the appropriate VA privacy training and annually complete required privacy training; and 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.] 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. 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. END OF PWS. Important information: The Government is not obligated to nor will it pay for or reimburse any costs associated with responding to this sources sought synopsis request. This notice shall not be construed as a commitment by the Government to issue a solicitation or ultimately award a contract, nor does it restrict the Government to a particular acquisition approach. The Government will in no way be bound to this information if any solicitation is issued. If response by Service Disabled Veteran Owned Small Business firms proves inadequate, an alternate set-aside or full and open competition may be determined. The North American Classification System (NAICS) code for this acquisition is 621511 Medical Laboratories ($32.5 Million). Notice to potential offerors: All offerors who provide goods or services to the United States Federal Government must be registered in the System for Award Management (SAM) at www.sam.gov and complete your Representations and Certifications (Reps and Certs). All interested Offerors should submit information by e-mail, mail or ground carrier to: Southern AZ VA HealthCare System, 3601 S. 6th Avenue, Tucson, AZ 85743 or by e-mail to Anne.Miller@va.gov. All information submissions to be marked Attn: Anne Miller, Contracting Officer (9-90C) and should be received no later than 4:00 pm Mountain Standard Time on July 31, 2018. After review of the responses to this announcement, the Government intends to proceed with the acquisition and a subsequent solicitation will be published.
 

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Document(s)

Attachment
 

File Name: 36C25818Q9662 36C25818Q9662.docx (https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=4501202&FileName=36C25818Q9662-000.docx)

Link: https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=4501202&FileName=36C25818Q9662-000.docx

 

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Place of Performance

Address: Southern Arizona VA Health Care System;3601 S. 6th Ave;Tucson, AZ

Zip Code: 85723
 

Record

SN05002190-W 20180725/180723230714-5c37ef4164b5a846ffaed30d4799d21d (fbodaily.com)
 

Source

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