VISN 12 Medical Transcription Contract This contract will be an IDIQ contract with a five year ordering period. The period of performance for this contract will begin on 01/01/2018-12/31/2022
Added: Jul 15, 2017 9:00 pm SOURCES SOUGHT SYNOPSIS The Department of Veterans Affairs is issuing this sources sought synopsis as a means of conducting market research to identify parties having an interest in and the resources to support a requirement for medical transcription toughout VISN 12. The result of this market research will contribute to determining the method of procurement and any relevant set-asides. The applicable North American Industry Classification System (NAICS) code assigned to this procurement is 561410 Medical Transcription. THERE IS NO SOLICITATION AT THIS TIME. This request for capability information does not constitute a request for quotes; submission of any information in response to this market survey is purely voluntary; the government assumes no financial responsibility for any costs incurred. The tentative requirements for this procurement are on pages, and the contracting officer welcomes input from vendors on the Statement of Work. Any input given by vendors will be evaluated by the contracting officer and may or may not be taken into consideration. If your organization has the potential capacity to perform these contract services, please provide the following information: Provide a brief description of your particular product/service that would satisfy the government s requirement. Marketing material is acceptable, please limit this to under 20 pages of material. BASED ON THE RESPONSES TO THIS SOURCES SOUGHT NOTICE/MARKET RESEARCH, THIS REQUIREMENT MAY BE SET-ASIDE FOR SDVOSBs, VOSBs, or SMALL BUSINESSES OR PROCURED THROUGH FULL AND OPEN COMPETITION. The government will evaluate market information to ascertain potential market capacity to provide services consistent in scope and scale with those described in this notice and otherwise anticipated. Telephone inquiries will not be accepted or acknowledged, and no feedback or evaluations will be provided to companies regarding their submissions. Submission Instructions: Interested parties who consider themselves qualified to perform the above-listed services are invited to submit a response to this Sources Sought Notice by 1800 CDT on 5 August, 2017. All responses under this Sources Sought Notice must be emailed to ryan.mcmillin@va.gov. PERFORMANCE BASED STATEMENT OF WORK: MEDICAL TRANSCRIPTION SERVICES FOR VISN 12 SCOPE OF WORK: All current facilities in VISN 12 have a requirement for digital dictation, traditional and correction editing medical transcription services using contractor supplied dictation equipment. VA Illiana Health Care System (VAIHCS) has a requirement for medical transcription services of progress note and limited consultation voice files dictated on VAIHCS dictation equipment. * VAIHCS utilizes their own dictation system and will share voice files for transcription. In accordance with FAR 4.703, contract files must be maintained for 3 years after final payment. The contractor must destroy the files on the anniversary of the third year after final payment using the 35-pass Gutmann-level deep scrub method or other equivalent methods. The method proposed by the contractor must have prior approval from the CO. All transcription and verification services must be performed in the United States of America, including US territories. Reports to be transcribed include: discharge summaries, operation reports, non-operative procedure reports, radiology and imaging reports, , progress notes, consultations, investigation and miscellaneous reports and letters. Material to be transcribed includes technical and medical terminology including a wide variety of specialized vocabulary. Material is dictated by many different physicians and allied health personnel with a wide range of dialects, vocal delivery, tone, pitch, volume, pronunciation and enunciation. All documents are dictated and transcribed in the English language. Contractor is responsible for accurate spelling, appropriate format per samples to be provided by the COR, and minor grammatical and punctuation changes to assure appropriate sentence structure as necessary. Contractor shall be responsible for checking medical dictionaries and reference sources when required to distinguish between similar sounding medical terms. VA will allow the contractor s staff to work off-site (i.e., at the employee s primary residence). However, the contractor s project manager is responsible for ensuring that their employees maintain the records in a safe and secure environment. Any examples for content, reference, or formatting must be de-identified. ORDERING PROCEDURES: Each VA location on this contract which orders services will submit to the Contracting Officer and the contractor a list of individuals with ordering authority. The placement of a record to be transcribed into the queue to be transcribed shall be considered an order for this contract. Only the Contracting Officer may obligate funds for task orders, but those with ordering official authority may place orders. EQUIPMENT REQUIREMENTS: The dictation system will be available for use twenty-four (24) hours a day. Contractor and VA can monitor the status of dictation and/or transcription of all reports at all times. VA will provide contractor with CAG access in addition to network and VistA accounts. Dedicated telephone lines for access to this dictation equipment will be provided by all sites in VISN 12 (Danville excluded, Danville s requirements are below). The transcribed data that will be batch uploaded (if possible) into VistA must be transcribed in ASCII format with data elements separated by delimiters. Delimiters will be specified by the appropriate VA personnel. EQUIPMENT REQUIREMENTS FOR VAIHCS: Contractor shall provide transcription services using voice files from the VA-owned dictation system, currently DAC digital dictation system VS-550. Contractor shall not have direct access to the digital dictation system but will retrieve voice files from a folder set up by VA Office of Information and Technology, Information Resources Management, specifically for this purpose. Contractor shall work with the current dictation system contractor, IRM, facility Information Security Officer (ISO) and Lead Transcriptionist, as necessary to facilitate set up for this action. Contractor will electronically transmit all transcribed reports into VISTA TIU via secure VPN network transmission. The protocol required for transmission of ASCII text files into VISTA is Kermit. Contractor is responsible to assure all documents uploaded into VISTA are accepted. EQUIPMENT DOWNTIME: The VA will notify contractor in the event that VistA is experiencing downtime. The Contractor will notify the VA within 30 minutes of any downtime that they are experiencing. In the event of a planned downtime, the contractor will provide 24 hour notice to the VA. WORKLOAD: Workload fluctuations shall not relieve the contractor from contract required turnaround times. During all peak transcription times contractor shall have adequate coverage to meet contract turnaround times. VA has no control over when the physician will dictate and the contractor shall be flexible in meeting the transcription needs of VA. Contractor shall provide transcription services 24-hours per day, seven days a week, including Federal Holidays, for beneficiaries of the VA. REPORT FORMAT AND INFORMATION: Reports to be transcribed include: discharge summaries, operation reports, non-operative procedure reports, radiology and imaging reports, , progress notes, consultations, investigation and miscellaneous reports and letters. Each transcribed report shall contain the following: 1. Patient s Last Name, and First Name (at the beginning of the report) 2. Date Dictated/Transcribed 3. Initials of Dictator and Initials or ID Number of Transcriptionist. VAIHCS requires only the name of the Dictator and Initials or ID Number of Transcriptionist. Returned documentation shall also include indication of cutoffs, problems and continuations. All information shall be verified by the contractor. The contractor shall record all required report information for all transcribed work. It is imperative this information be verified and accurate to assure proper processing of all work and verification of work performed to reconcile bills. The contractor shall transcribe reports utilizing headers and footers and appropriate formats. The contractor shall transmit, and/or upload completed reports to VA using transmission protocols provided by the VA. It is the contractor s responsibility to assure that all header required information complies with the dictation. Contractor is responsible for uploading and correction of upload errors under this contract. The contractor must confirm that the upload is complete and the report is available. Any upload errors by the contractor that must be corrected by the contractor and shall be at no cost to the VA. Upload errors include, but are not limited to: wrong note titles assigned during upload, uploading to incorrect patient name, SSN, or appointments/admission date (or date of admission or procedure), or deviations from VA location list provided by VA, and errors in the name of dictating provider and attending physician (if applicable). Upload errors caused by errors or omission on the part of the VA author do not count against the contractor s turn-around time performance, provided that the contractor notified the COR or designee in a manner mutually agreed upon between the transcription project manager and the COR. VAIHCS will correct all VA alerts generated at VAIHCS for work uploaded by the contractor. The length of each report will vary according to the type of medical report required. The text is single spaced with double space between paragraphs, with the exception of investigation reports. Investigation reports have special formatting including double spacing. No report shall include any text other than what was dictated. Instructions to the transcriptionist shall not be included in the body of the report. Comments or questions shall be sent as separate correspondence referencing the dictation system job number. Typed comments or questions are not counted as billable. Specific reports formats provided by VA shall be followed. Revised formats will be provided to the contractor as necessary. When revised formats are provided, the contractor shall make revisions to format within 24 hours. Contractor shall confine abbreviations to those that have been approved by the VA. Symbols and abbreviations shall not be used when documenting final diagnoses and procedures on discharge summaries. The contractor shall provide the VA with either a toll free long distance or local phone number for contacting the contractor. The contractor shall ensure that a designated responsible individual is available to provide telephone support, service and error correction between the hours of 8:00 am and 4:30 pm, central time, Monday tough Friday. Partial dictation is any incomplete report. Dictation may be interrupted if there is an equipment malfunction or if the dictator terminates the dictation prior to the end of the report. Contractor will combine segments of the same report prior to final preparation, delivery and billing to VA. TURN-AROUND TIME REQUIREMENTS: Emergency reports are expedited summaries. All other dictation shall be considered routine unless VA notifies contractor by telephone, e-mail, or fax that it is an emergency . Reports shall be completed and returned to VA after receipt of dictation by the physician. The contractor shall provide all transcribed reports in accordance with the following deadlines: 1. Routine Requirements Delivery completed to VistA within twenty-four (24) hours from completion of dictation. 2. Emergency Requirements Delivery completed to VistA within four (4) hours from completion of dictation. With the exception of emergency reports, all other reports shall be transcribed in date order by the report date. Example: Reports dated the 3rd or 4th shall be transcribed prior to the reports dated the 5th or 6th unless the latter reports are from a prior month, in which case they are considered older and should be transcribed first (first in first out). Table 1. Turnaround Times (TAT) a. Discharge Summary 24 hours b. Operation Report 24 hours c. Compensation and Pension Report 24 hours d. Consultation 24 hours e. Progress Note 24 hours f. *History and Physical Exam 24 hours g. Stat Reports all work types .5 hours h. Miscellaneous Reports 24 hours i. **Radiology/Nuclear Medicine 24 hours ERRORS, CORRECTIONS, AND LOST REPORTS: The VA will notify the contractor, by telephone or in writing, of any errors found. The acceptable error rate is up to two percent (2%) per report. At the government s option, reports within the acceptable error rate may be returned to the contractor for correction at no additional charge to the VA and returned within twenty-four (24) hours (if emergency , four (4) hours) or corrected locally by VA personnel. Errors over two percent (2%) per report, at the government s option, may be returned to the contractor for correction at no charge to the VA and returned within twenty-four (24) hours (if emergency , four (4) hours) or corrected locally by VA personnel with a deduction of $.50 will be taken from the amount otherwise to be paid to the contractor for each error in typing data which is verifiable. The contractor shall be responsible for ensuring that all transcription is prepared using correct grammar, punctuation, tense, spelling, and medical terminology. Contractor shall refer to English and medical dictionaries when necessary to distinguish between similar sounding medical terms. The contractor shall exercise judgment when making corrections that shall not change the intent or sentence structure. Errors or omissions in material that are technical in nature shall be referred back to the author for correction or clarification. Only authorized abbreviations by the VA shall be incorporated into the medical reports. A list of approved abbreviations shall be provided to the contractor by the COR upon award of the contract and upon each subsequent revision. A sample listing is provided herein. The contractor shall also ensure that the patient names, social security numbers, and dictating physician s name are accurately transcribed and in the correct format. A list comprising the names of staff members will be provided to the contractor and will be updated as needed. The contractor shall maintain a quality standard of 98% accuracy based on a monthly random sampling report. The random sampling report will include the total number lines of all reports included in the sample. Percentage is based on ratio of errors to lines. (Example: 1000 lines produced, 20 errors: 20/1000=0.02 or 2% errors. Accuracy is therefore at 98 %.) Examples of errors are (list is not exhaustive): (1) Omitted material that is legible or intelligible (2) Misspelled words (3) Transposed letters (4) Information located in the wrong category or field (5) Typing other than what is dictated (6) Punctuation if it changes the context of the sentence (7) Use of unapproved abbreviations (8) Blanks A 1% deduction from payment due to the contractor may be applied for each percentage point below 98%. If the random sampling reports fall to 98% or below, then a 20% deduction from payment due to the contractor will be applied to the entire month s invoice. The COR will submit the report to the contracting officer for approval of deductions. If the random sampling report shows a quality standard below 98% for two consecutive months, work performance may be deemed unacceptable and may be cause for termination of the contract. Contractor shall be accountable for any lost reports. Any transcription redone due to a lost report by the contractor shall be transcribed and returned within four (4) hours after receipt at no charge to VA. UNIT OF PRICING (SEE CLINS ALSO): A visible black character (VBC) is defined as strike-able and visible characters and includes any printed letter, number, symbol, and/or punctuation mark excluding any or all formatting (e.g. bold, underline, italics, table structure, formatting codes, spaces or returns). All visible black characters can be seen regardless of whether it is viewed electronically or on a printed page. A B C D E F G H I J K L M N O P Q R S T U V W X Y Z a b c d e f g h i j K l m n o p q r s t u v w x y z ~ ! @ # $ % ^ & * ( ) _ + { } | : ? ÷ ± ` 1 2 3 4 5 6 7 8 9 0 - = [ ] \ ; , . / The VBC Line or the American Standard Code for Information Interchange (ASCll) no Spaces Line: A VBC line is defined as the total number of characters, printed or visible, that s part of the final transcribed document. This includes any character contained in a header or footer. Spaces between words or sentences, carriage returns, hidden format instructions, such as bold, underline, text boxes, printer configurations, spell check, etc., are not included in the total character count. A VBC line is calculated by counting all visual characters and dividing the total number of characters by 65 to arrive at the number of defined lines. RECORD KEEPING/CONFIDENTIALITY: VA will provide the contractor with access to pertinent patient medical information for the purposes of providing a service to VA. The contractor shall ensure the confidentiality of all patient information and shall be held liable in the event of breach of confidentiality. The contractor shall comply with the provisions of the Privacy Act of 1974 (5 U.S.C. 522a), Confidentiality of Drug Abuse, Alcohol Abuse, Sickle Cell Anemia and HIV/AIDS Treatment Records (38 U.S.C. 7332 and 38 U.S.C. 4132), and Confidentiality of Medical Quality Assurance Records (38 U.S.C. 5705 and 38 U.S.C. 3305) as well as any other statutes that pertain to confidentiality. Any person who knowingly and willfully discloses confidential information from health services, review organizations, or medical records may be subject to criminal penalties and/or fines up to $20,000.00. The medical records described in this solicitation and the ensuing contract are irreplaceable medical information that must be safeguarded at all times. Contractor shall develop and maintain a method of tracking all dictated and transcribed documents. The contractor is not authorized to release any medical record information. The VA is the sole entity authorized to release any information upon written authorization from the patient. Clinical or other medical records of VA beneficiaries transcribed by contractor under this contract are VA records and will be forwarded to the VA. Contractor shall keep copies or recording of each report for tee (3) months after transcription is complete. VA reports must be maintained in a safe, secure manner. Contractor will purge all document types prepared 90 days after transcribing the document(s). Contractor employees accessing the VA VistA computer system shall be required to sign and abide by VA Computer Access Security Agreement. Contractor employees are required to complete security training and sign a computer security agreement prior to accessing the VistA computer system. In addition, Contractor employees much complete annually privacy, cyber security and compliance training. Confidentiality agreements do not need to be completed and submitted with proposal. Agreements shall be required from all contractor personnel prior to contract performance and submitted to the COR. HHS/OIG: To ensure that the individuals providing services under the contract have not engaged in fraud or abuse regarding Sections 1128 and 1128A of the Social Security Act regarding federal health care programs, the contractor is required to check the Health and Human Services - Office of Inspector General (HHS/OIG), List of Excluded Individuals/Entities on the OIG Website (www.hhs.gov/oig) for each person providing services under this contract. Further the Contractor is required to certify in its proposal that all persons listed in the contractor s proposal have been compared against the OIG list and are NOT listed. During the performance of this contract the contractor is prohibited from using any individual or business listed on the List of Excluded Individuals/Entities. QUALITY ASSURANCE SURVEILLANCE PLAN (QASP) INTRODUCTION: This quality assurance surveillance plan (QASP) is pursuant to the requirements listed in the performance work statement (PWS). This plan sets forth the procedures and guidelines the VA will use in ensuring the required performance standards or services levels are achieved by the contractor. PURPOSE: The purpose of the QASP is to describe the systematic methods used to monitor performance and to identify the required documentation and the resources to be employed. The QASP provides a means for evaluating whether the contractor is meeting the performance standards and quality levels identified in the PWS. This QASP defines the roles and responsibilities of all members of the integrated project team (IPT), identifies the performance objectives, defines the methodologies used to monitor and evaluate the contractor s performance, describes quality assurance documentation requirements, and describes the analysis of quality assurance monitoring results. ROLES AND RESPONSIBILITIES: The Contracting Officer: The contracting officer (CO) is responsible for monitoring contract compliance, contract administration, and cost control and for resolving any differences between the observations documented by the Contracting Officer's Representative (COR) and the contractor. The CO will designate one full-time COR as the government authority for performance management. The number of additional representatives serving as technical inspectors depends on the complexity of the services measured, as well as the contractor s performance, and must be identified and designated by the CO. The Contracting Officer s Representative: The contracting officer s representative (COR) is designated in writing by the CO to act as his or her authorized representative to assist in administering a contract. COR limitations are contained in the written appointment letter. The COR is responsible for technical administration of the project and ensures proper government surveillance of the contractor s performance. The COR is not empowered to make any contractual commitments or to authorize any contractual changes on the government s behalf. Any changes that the contractor deems may affect contract price, terms, or conditions shall be referred to the CO for action. The COR will have the responsibility for completing QA monitoring forms used to document the inspection and evaluation of the contractor s work performance. Government surveillance may occur under the inspection of services clause for any service relating to the contract. ANALYSIS OF QUALITY ASSURANCE ASSESSMENT: Determining Performance: Government shall use the monitoring methods cited to determine whether the performance standards/service levels/AQLs have been met. If the contractor has not met the minimum requirements, it may be asked to develop a corrective action plan to show how and by what date it intends to bring performance up to the required levels. Performance Management Approach: The PWS structures the acquisition around what service or quality level is required, as opposed to how the contractor should perform the work (i.e., results, not compliance). This QASP will define the performance management approach taken by VAMC Health Information Management System (HIMS) Office to monitor and manage the contractor s performance to ensure the expected outcomes or performance objectives communicated in the PWS are achieved. Performance management rests on developing a capability to review and analyze information generated tough performance assessment. The ability to make decisions based on the analysis of performance data is the cornerstone of performance management; this analysis yields information that indicates whether expected outcomes for the project are being achieved by the contractor. Performance management represents a significant shift from the more traditional quality assurance (QA) concepts in several ways. Performance management focuses on assessing whether outcomes are being achieved and to what extent. This approach migrates away from scrutiny of compliance with the processes and practices used to achieve the outcome. A performance-based approach enables the contractor to play a large role in how the work is performed, as long as the proposed processes are within the stated constraints. The only exceptions to process reviews are those required by law (federal, state, and local) and compelling business situations, such as safety and health. A results focus provides the contractor flexibility to continuously improve and innovate over the course of the contract as long as the critical outcomes expected are being achieved and/or the desired performance levels are being met. METHODOLOGIES TO MONITOR PERFORMANCE: Surveillance Techniques: Contractor shall submit a monthly quality control report to the COR, of any documents returned for correction. This report shall address corrective action taken and follow-up measures. In an effort to minimize the performance management burden, simplified surveillance methods shall be used by the government to evaluate contractor performance when appropriate. The contractor shall implement and maintain a Quality Control System that results in correction of potential and actual problems toughout the scope of contract performance. The Quality Control System shall contain processes for corrective actions without dependence upon Government direction and shall maintain records of all contractor quality control inspections and corrective actions. The primary methods of surveillance are: Contractor shall submit a monthly quality control report to the COR, of any documents returned for correction. This report shall address corrective action taken and follow-up measures. Random monitoring, which shall be performed by the COR or COR designated inspector. Periodic Inspection COR or designated inspector typically performs the periodic inspection on a monthly basis. QUALITY ASSURANCE DOCUMENTATION: Monitoring Forms The government s QA surveillance, accomplished by the COR, will be reported using the monitoring form in Attachment 2. The form, when completed, will document the government s assessment of the contractor s performance under the contract to ensure that the required results are being achieved. The COR will retain a copy of all completed QA surveillance forms. ATTACHMENT 1: PERFORMANCE REQUIREMENTS SUMMARY Task Indicator Standard Acceptable Quality Level Turnaround Times (TAT) All dictation shall be transcribed and uploaded into VISTA See Table 1 Below 99% Contractor Availability The Contractor shall be available to perform all transcription services to include electronic transmission of transcription to the VA. Contractor shall perform timely completion and transmittal of transcriptions on a daily basis twenty-four (24) hours per day, seven (7) days per week including weekends and holidays. 98% Report Accuracy Maintain timely completion and transmittal of transcription and provide a primary contact within Contractor Company to expedite resolution of issues that may arise Contractor shall maintain an overall 98% accuracy rate 98% STAT Reports TAT Any requested (all work types). Response time of not more than thirty (30) minutes is required. 98% Report Correction Any reports returned to the Contractor for correction for reasons stated in SOW, or reports that are otherwise unacceptable to the VA will be returned to the Contractor. Reports shall be corrected within four (4) hours for routine reports and within one (1) hour for STAT reports. 98% ATTACHMENT 2: SAMPLE QUALITY ASSURANCE MONITORING FORM SERVICE: SURVEY PERIOD: SURVEILLANCE METHOD (Check): r Random Sampling r 100% Inspection r Periodic Inspection r Customer Complaint LEVEL OF SURVEILLANCE (Check): r Monthly r Quarterly r As needed PERCENTAGE OF ITEMS SAMPLED DURING SURVEY PERIOD: ______ % ANALYSIS OF RESULTS: Observed Service Provider Performance Measurement Rate: ______% Service Provider s Performance (Check): r Meets Standards r Does Not Meet Standards Narrative of Performance During Survey Period: PREPARED BY: ___________________________________ DATE: _________________ BACKGROUND INVESTIGATIONS: Failure to comply with the contractor personnel security requirements may result in termination of the contract for default. All contractor employees who require access to the Department of Veterans Affairs' computer systems or have access to sensitive information shall be the subject of a background investigation. The VA obtains the Background Investigation tough the Electronic Questionnaires for Investigations Process (e-QIP). Upon receiving a request for the investigation from the Contracting Officer, the contractor s employee will be initiated into e-QIP for the Background Investigation followed by an e-mail with instructions to log into e-QIP. A contractor s employee shall not commence working at VA under contract until the Contracting Officer receives notification from the VA Office of Security and Law Enforcement that the contract employee s application was received complete. A favorable adjudication from the VA Office of Security and Law Enforcement must be received in order for a contractor employee to continue contract performance. This requirement is applicable to all subcontractor personnel. Upon award, the Contracting Officer shall provide the contractor with a Notice of Award letter, which includes the Contractor Security Procedure Flowchart and Guide 6500.6 Appendix. The Notice of Award letter instructs the contractor to go to the VHA Service Center website to obtain the VHA Service Center (VSC) Security Request Packet, which contains all the forms that the contractor must fill out. After award, contractors can contact the Contracting Officer s Representative for assistance in scheduling an appointment for fingerprinting to start the process. 1. Position Sensitivity - The position sensitivity has been designated as: LOW 2. Background Investigation - The level of background investigation commensurate with the required level of access is National Agency Check with Written Inquiries CONTRACTOR RESPONSIBLITIES: The contractor shall bear the expense of obtaining background investigations. If the Office of Personnel Management (OPM) conducts the investigation, the contractor shall reimburse VA within 30 days. If timely payment is not made within 30 days from date of bill for collection, then VA shall deduct the cost incurred from the contractors 1st month s invoice(s) for services rendered. It is imperative for the contractor to provide, at the request of VA, a listing of contractor personnel performing services under the contract in order for the background investigation process to commence. This list will include name (first, middle, last) social security number; date of birth; city, state, and country of birth. The contractor or their employees shall submit a complete background investigation packet tough the Electronic Questionnaires for Investigations Process (e-QIP). Additional guidance and information will be provided tough e-mail from the VA Office of Security and Law Enforcement. The following required forms must be submitted tough the e-QIP system to the VA Office of Security and Law Enforcement before contract performance begins: (i) e-QIP Signature Pages (two) (print, sign and submit) (ii) Optional Form 306, Declaration for Federal Employment Electronic Fingerprint Form (FD 258) or electronic fingerprints Fingerprinting is required with the background investigation. Fingerprinting can be done at the local VA Facility. The Electronic Fingerprint Verification Form must be submitted with the above required forms. The Contractor shall inform the contract employee that when filling out the application, that there should be no gaps in employment history. Any gaps in employment history may result in OPM rejecting the documentation for investigation and delay contract performance. The contractor, when notified of an unfavorable determination by the Government, shall withdraw the employee from consideration from working under the contract, and at the request of the VA, submit another employee for consideration. The contractor may utilize a private investigating agency if such agency possesses an OPM and Defense Security Service certification. A Cage Code number must be provided to the VA Office of Security and Law Enforcement. VA Office of Security and Law Enforcement will verify the information and advise the contracting officer whether contractor s access to the computer systems can be authorized. All contractor employees and subcontractors are required to complete VA s Privacy training annually. All Contractor employees and subcontractors requiring access to VA computer network are required to complete Cyber Security training courses annually either on-line or hard copy. Documented proof must be provided to the Contracting Officer. The contractor will notify the COR immediately when their employee(s) no longer require access to VA computer systems. GOVERNMENT RESPONSIBILITIES: The contracting officer will request the contractor employee s background investigation by the Office of Security and Law Enforcement. The Office of Security and Law Enforcement will notify the contractor with instructions for the contractor's employees, coordinate the background investigations, and notify the contracting officer and contractor of the results of the investigations. The VA facility will pay for requested investigations in advance. A bill for collection will be sent to the contractor to reimburse the VA facility. The contractor will reimburse the VA facility within 30 days. If timely payment is not made within 30 days from date of bill for collection, then VA shall deduct the cost incurred from the contractors 1st month s invoice(s) for services rendered. 2017 FEES: The current fees associated with background investigations are $392.00 each for low level investigation, $1,388.00 each for medium level investigation, and $4,476.00 each for high level investigation. VA INFORMATION AND INFORMATION SYSTEM SECURITY/PRIVACY LANGUAGE 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 tough 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 onsite 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 ), toughout 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 2 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 3 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 vulnerability scanning, system patching and change management procedures, and the completion of an acceptable contingency plan for each system. The contractor s security control procedures must be equivalent, to those procedures used to secure VA systems. A Privacy Impact Assessment (PIA) must also be provided to the COR and approved by VA Privacy Service prior to operational approval. All external Internet connections to VA s network involving VA information must be reviewed and approved by VA prior to implementation. 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, and 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-days 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 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.
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