D1. SOW.docx

1. CONTRACT TITLE

Automatic Doors Preventative Maintenance & Repair

2. PLACE OF PERFORMANCES

VA San Diego Healthcare System 3350 La Jolla Village Dr.

San Diego, CA 92161

3. PERIOD OF PERFORMANCE

Base Year #0: 07/01/2024 – 06/30/2025 Option Year #1: 07/01/2025 – 06/30/2026 Option Year #2: 07/01/2026 – 06/30/2027 Option Year #3: 07/01/2027 – 06/30/2028 Option Year #4: 07/01/2028 – 06/30/2029

4. CONTRACT TYPE

Firm Fixed Price

5. DESCRIPTION/SPECIFICATION/WORK STATEMENT

The Clinical Documentation Improvement Specialist (CDIS) is responsible for abstracting medical record data and assigning codes using current clinical classification systems appropriate for the care type provided. The facility is requesting a base plus four-option-year contract:

· CDISs are responsible for facilitating improved overall quality, education, completeness, and accuracy of medical record documentation, as well as promoting appropriate clinical documentation through extensive interaction with physicians, other patient caregivers, HIM coding staff, and other associated staff to ensure clinical documentation and services rendered to patients is complete and accurate for appropriate workload capture and resource allocations.

· Develop and update medical center policy memoranda about documentation improvement.

· Serve as a technical expert in health record content and documentation requirements.

· Responsible for performing reviews of the health record documentation; developing criteria; collecting data; graphing and analyzing results; creating reports; and communicating in writing and in-person to appropriate leadership and groups.

· Obtain appropriate corrective action plans from responsible clinical services directors when necessary and recommend improvements or changes in documentation.

· Adhere to established documentation requirements as outlined by accrediting agencies guidelines, regulations, policy, and medical-legal requirements.

· Responsible for developing and implementing active training/education programs (i.e., seminars, workshops, short courses, informational briefings, and conferences) for all providers while ensuring and meeting the CDIS program objectives.

· Certification at this grade is highly recommended. The MRT (Contractor) (CDIS) is a staff position located in the Health Information Management Service (HIMs) at VA San Diego Healthcare System.

Basic Functions

· Applies comprehensive knowledge of medical terminology, anatomy & physiology, disease processes, treatment modalities, diagnostic tests, medications, and procedures, as well as the principles and practices of health services and the organizational structure to ensure proper code selection.

· Selects and assigns codes from the current version of several coding systems, including current versions of the International Classification of Diseases (ICD), Current Procedural Terminology (CPT), or Healthcare Common Procedure Coding System (HCPCS).

· Adheres to accepted coding practices, guidelines, and conventions when choosing the most appropriate diagnosis, operation, procedure, ancillary, or Evaluation and Management code to ensure ethical, accurate, and complete coding; also applies codes based on guidelines specific to certain diagnoses, procedures, and other criteria (in inpatient and outpatient settings) used to classify patients under the Veterans Equitable Resource Allocation (VERA) program that categorizes all VA patients into specific classes representing their clinical conditions and resource needs.

· Monitors ever-changing regulatory and policy requirements affecting coded information for the full spectrum of services provided by the VAMC. Timely compliance with coding changes is crucial to the accuracy of the facility database, and all cost recovery programs.

· Assists facility staff with documentation requirements to entirely and accurately reflect the patient care provided; provides technical support in regulations and policy, coding requirements, resident supervision, reimbursement, workload, accepted terminology, and proper sequencing. Ensures provider documentation is complete and supports the diagnoses and codes of procedures. Directly consults with the professional staff to clarify conflicting or ambiguous clinical data. Reports incorrect documentation or codes in the electronic patient health record.

· Expertly searches the patient health record to find documentation justifying code assignment based on an expanded knowledge of the organization and structure of the patient record.

· Uses a variety of window-based applications in day-to-day activities and duties, such as Outlook, Excel, Word, and Access; competent in the use of the health record applications (Vista and CPRS) as well as the contractor’s product suite. Ensures current versions of all software applications are loaded and functional after any updates or changes.

Specific Functions

· The contractor develops and conducts seminars, workshops, short courses, informational briefings, and conferences concerned with health record documentation and educational and functional training requirements to meet program objectives for clinical and Health Information Management (HIM) staff.

· Ensures that an active intra-departmental training program is in place for the HIM staff. Determines and meets training needs of extra-departmental professional, para-professional, and non-professional personnel by originating training material, providing orientation to newly assigned interns and residents, and participating in in-service programs conducted throughout the hospital.

· Facilitates improved overall quality, completeness, and accuracy of health record documentation and promotes appropriate clinical documentation through extensive interaction with physicians, other patient caregivers, and HIM coding staff to ensure clinical documentation and services rendered to patients are complete and accurate.

· Ensures the accuracy and completeness of clinical information used for measuring and reporting physician and medical center outcomes with continuing education to all members of the patient care team on an ongoing basis.

· Collaboratively works with the professional clinical staff and provides support and education on documentation issues. Assists in developing guidelines for data compatibility, consistency, and compliance monitoring to improve the quality of clinical, financial, and administrative data and ensure that all information is fully documented and supported. Such efforts are conducted to ensure the accuracy of billing denials and prevention against fraud and abuse and to optimize the medical center’s authorized reimbursement for utilization of resources provided.

· As a technical expert in health record documentation, the contractor provides advice and guidance concerning documentation requirements, liability issues, advance directives, informed consent, patient privacy and confidentiality, state reporting, etc.

· Analyzes situations or processes and recommends necessary improvements or changes in documentation. It may assist in writing coding protocols/policies that reflect the required changes to enhance revenue through improved documentation.

· Compiles, reviews, abstracts, analyzes, and interprets medical data incidental to various patient care and treatment activities. Conducts daily reviews of all new admissions to designated clinical services to identify those with potential documentation improvements through periodic evaluation during the patient’s stay. Review the health record and discuss the case with the clinical staff. Performs admission reviews for specific patient populations to facilitate appropriate clinical documentation and ensure the health record accurately reflects the level of services and understanding of care. Reviews the appropriateness of patient working Diagnosis Related Group (DRG) and length of stay information by reviewing all clinical documentation, lab results, diagnostic information, and treatment to ensure documentation reflects the severity of illness, acuity, and resource consumption.

· Participates in clinical rounds and may, where appropriate, offer information on documentation, coding rules, and reimbursement issues. The documentation specialist is a healthcare team member and shall assist all clinical providers with ICD, CPT, and DRG methodologies so that documentation will more accurately reflect the occurrence of the encounter.

· Maintains statistical database(s) to track the results and validate the program for identifying patterns and variations in coding practices with regular reports to the medical staff and management.

· The documentation specialist is expected to strive for the optimal payment to which the facility is legally entitled. Still, maximizing payment by means that contradict regulatory guidelines is deemed unethical and illegal, e.g., upcoding, DRG creep, etc. Selection of the principal diagnosis and principal procedure and other diagnoses and procedures must meet the Uniform Hospital Discharge Data Set (UHDDS) definitions.

*****VA ICD-10: In 2015, implementing to code using ICD-10 is mandatory. The contractor will be required to code using ICD 10. The contractor shall assume the responsibility for the training; the contractor will need to meet the ICD 10 coding competency. The contractor will need to maintain any/all quality and quantity standards. *****

6. GUIDELINES

The contractor shall adhere to all coding guidelines accepted by VA policy, including but not limited to the following:

· Official Guidelines and Reporting as found in the CPT Assistant, a publication of the American Medical Association

· Official Guidelines for Coding Reporting in Coding Clinic for ICD-10-CM, a publication of the American Hospital Association

· VHA guidelines for coding are found in the Handbook for Coding Guidelines (most recent edition), Health Information Management, and Department of Veterans Affairs.

· CMS Ruling – Documentation Requirements for VA Teaching Physicians as signed by Robert H. Roswell, MD, Under Secretary for Health, AND related documents and guidelines.

7. CONFIDENTIALITY AND SECURITY:

The Contractor shall:

· Ensure the confidentiality and security of all patient information and shall be held liable in the event of a breach of confidentiality. The Contractor shall comply with the provisions of the Privacy Act (5 USC 522a), Confidentiality of Drug Abuse, Alcohol Abuse, Sickle Cell Anemia and HIV/AIDs Treatment Records (38 USC 7332 and 38 USC 4132), VA Claims Confidentiality Statute (38 USC 5701) and Confidentiality of Medical Quality Assurance Records (38 USC 5705 and 38 USC 3305).

· The Contractor shall comply with all pertaining confidentiality and security statutes. The Contractor shall be HIPPA compliant (Health Insurance Portability and Accountability Act).

· Failure to comply with laws regarding privacy and security of patient health information/individually identifiable information may result in financial sanctions. The Contractor shall certify that all employees performing services under this contract have received HIPAA training.

· The Contractor shall be responsible for ensuring the confidentiality and security of all patient information and shall be held liable for any breach of privacy. Access requirements to VA information systems by Contractor personnel shall meet or exceed those requirements established for VA employees as promulgated in VA/VHA administrative issues, including directives. Access shall be granted to non-VA users only if the purpose of access is consistent with all privacy and security policies and regulations. Contractor personnel must sign access agreements before starting work under this contract. These agreements required them to abide by VA computer access security and confidentiality policies.

· The Contractor shall sign a Business Associate Agreement (BAA) between itself and the Department of Veterans Affairs.

8. VA INFORMATION AND INFORMATION SYSTEM SECURITY/PRIVACY

The contractor, personnel, and subcontractors shall be subject to federal laws, regulations, standards, VA directives, and handbooks regarding information and information system security as delineated in this contract.

9. 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.

10. ACCESS TO VA INFORMATION AND VA INFORMATION SYSTEMS

The 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, third-party servicers, and associates working with VA information are subject to the exact investigative requirements of VA appointees or employees with access to the same types of information. The level and process of background security investigations for contractors must be by 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. Executive Order 12829 established the National Industrial Security Program (NISP) 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 the 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 in the U.S. to the maximum extent practical. Suppose such services are proposed to be performed abroad and are not disallowed by other VA policies or mandates. In that case, the contractor/subcontractor must state where all non-U.S. services are provided and detail a security plan deemed acceptable by the 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 accessing 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 before an unfriendly termination.

11. 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 the performance or administration of the contract shall be used only for those purposes:

· It 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 to ensure VA requirements related to data protection and media sanitization can be met. Suppose co-mingling must be allowed to meet the business's requirements. In that case, the contractor must ensure that the VA's Information is returned to the VA or destroyed in accordance with the 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 follow VA directive requirements.

· Before termination or completion of this contract, the contractor/subcontractor must only destroy Information received from the VA or gathered/created by the contractor while performing this contract with prior written approval by the VA. Any data destruction done on behalf of VA by a contractor/subcontractor must be done per 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 contract terms 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 under VHA Handbook 1600.01, Business Associate Agreements. There is no business associate relationship without an agreement to use or disclose protected health information.

· 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.

· If applicable, the contractor/subcontractor's firewall and Web services security controls 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 the performance of the agreement, 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 USC 5705, the confidentiality of medical quality assurance records, and Title 38 USC 7332, the confidentiality of certain health records about drug addiction, sickle cell anemia, alcoholism or alcohol abuse, or infection with human immunodeficiency virus. Suppose the contractor/subcontractor has received a court order or other requests for the Information mentioned above. In that case, 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 COTR.

12. INFORMATION SYSTEM DESIGN AND DEVELOPMENT

A. Information systems designed or developed for or on behalf of VA at non-VA facilities shall comply with all VA directives developed per 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 CFR Part 164, Subpart C, information, and designations of system security categorization level under FIPS 199 and FIPS 200 with the 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 (PIAPIA) must be completed, provided to the COTR, and approved by the VA Privacy Service by Directive 6507, VA Privacy Impact Assessment.

B. The contractor/subcontractor shall certify to the COTR that applications are fully functional and operate correctly as intended on systems using the VA Federal Desktop Core Configuration (FDCC) and the standard security configuration guidelines provided by NIST or the VA. This includes Internet Explorer 7, which is configured to operate on Windows XP and Vista (in Protected Mode on Vista) and future versions, as required.

C. The standard installation, operation, maintenance, updating, and patching of the 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.

D. Applications designed for normal end users shall run in the standard user context without elevated system administration privileges.

E. The security controls must be designed, developed, approved by VA, and implemented per the provisions of the 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.

F. The contractor/subcontractor is required to design, develop, or operate a System of Records Notice (SORSOR) on individuals to accomplish an agency function subject to the Privacy Act of 1974 (as amended), Public Law 93-579, December 31, 1974 (5 USCUSC 552a) and applicable agency regulations. Violating the Privacy Act may involve the imposition of criminal and civil penalties. The contractor/subcontractor agrees to:

1. 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 identifies explicitly:

a) The Systems of Records (SORSOR); and the design, development, or operation work that the contractor/subcontractor is to perform.

b) Include the Privacy Act notification contained in this contract in every solicitation and resulting in 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 SORSOR on individuals that is subject to the Privacy Act.

2. 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 SORSOR.

G. 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 SORSOR on individuals to accomplish an agency function. Criminal penalties may be imposed upon the officers or employees of the agency when the violation concerns the operation of a SORSOR on individuals to accomplish an agency function. For purposes of the Act, when the contract is for the operation of a SORSOR on individuals to accomplish an agency function, the contractor/subcontractor is considered an employee of the agency:

1. "Operation of a System of Records" means performing any of the activities associated with maintaining the SORSOR, including collecting, using, maintaining, and disseminating records.

2. "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 assigned to the individual, such as a fingerprint or voiceprint, or a photograph.

3. "System of Records" means a group of any records under the control of any agency from which information is retrieved by the individual's name or by some identifying number, symbol, or other identifying assigned to the individual.

H. The vendor shall ensure the security of all procured or developed systems and technologies, including their subcomponents (from now on 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) that 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 do not negatively impact the Systems.

I. The vendor shall notify VA within 24 hours of the discovery or disclosure of successful exploits of the vulnerability that can compromise the security of the Systems (including the confidentiality or integrity of its data and operations or the system's availability). The contractor shall remediate such issues as quickly or as practicable, but in no event longer than _10___ days.

J. When the security fixes involve installing third-party patches (such as Microsoft OSOS patches or Adobe Acrobat), the vendor will notify the VA that the patch has been validated and will not affect the systems within ten working days. When the vendor is responsible for the operations or maintenance of the Systems, they shall apply the Security Fixes within _10___days.

K. All other vulnerabilities shall be remediated as specified in this paragraph promptly 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 the approval of the contracting officer and the VA Assistant Secretary for the Office of Information and Technology.

13. INFORMATION SYSTEM HOSTING, OPERATION, MAINTENANCE, OR USE

A. For information systems that are hosted, operated, maintained, or used on behalf of VA at non-VA facilities, contractors/subcontractors are fully responsible and accountable for ensuring compliance with all HIPAA, Privacy Act, FISMA, NIST, FIPS, and VA security and privacy directives and handbooks. This includes conducting compliant risk assessments, routine vulnerability scanning, system patching and change management procedures, and the completion of an acceptable contingency plan for each system. The contractor’s security control procedures must be equivalent to those procedures used to secure VA systems. A Privacy Impact Assessment (PIA) must also be provided to the COTR and approved by VA Privacy Service prior to operational approval. All external Internet connections to VA’s network involving VA information must be reviewed and approved by VA prior to implementation.

B. Adequate security controls for collecting, processing, transmitting, and storing of Personally Identifiable Information (PII), as determined by the VA Privacy Service, must be in place, tested, and approved by VA prior to hosting, 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.

C. 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.

D. 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 the documentation (PIA, System Security Plan, Contingency Plan). The Certification Program Office can provide guidance on whether a new C&A would be necessary.

E. 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 COTR. 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.

F. VA prohibits the installation and use of personally owned or contractor or 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 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.

G. 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.

H. Bio-Medical devices and other equipment or systems containing media (hard drives, optical disks, etc.) with VA sensitive information must not be returned to the vendor at the end of lease, for trade-in, or other purposes. The options are:

1. Vendor must accept the system without the drive.

2. VA’s initial medical device purchase includes a spare drive which must be installed in place of the original drive at time of turn-in; or

3. VA must reimburse the company for media at a reasonable open market replacement cost at time of purchase.

4. Due to the highly specialized and sometimes proprietary hardware and software associated with medical equipment/systems, if it is not possible for the VA to retain the hard drive, then:

· 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 preapproved 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.

14. 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 COTR and simultaneously, the designated ISO and Privacy Officer for the contract of any known or suspected security/privacy incidents, or any unauthorized disclosure of sensitive information, including that contained in system(s) to which the contractor/subcontractor has access.

· To the extent known by 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.

15. LIQUIDATED DAMAGES FOR DATA BREACH

A. 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.

B. 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.

C. Each risk analysis shall address all relevant information concerning the data breach, including the following:

1. Nature of the event (loss, theft, unauthorized access)

2. Description of the event, including:

a) date of occurrence

b) data elements involved, including any PII, such as full name, social security number, date of birth, home address, account number, disability code.

3. Number of individuals affected or potentially affected.

4. Names of individuals or groups affected or potentially affected.

5. Ease of logical data access to the lost, stolen or improperly accessed data considering the degree of protection for the data, e.g., unencrypted, plain text.

6. Amount of time the data has been out of VA control.

7. The likelihood that the sensitive personal information will or has been compromised (made accessible to and usable by unauthorized persons).

8. Known misuses of data containing sensitive personal information, if any.

9. Assessment of the potential harm to the affected individuals.

10. Data breach analysis as outlined in 6500.2 Handbook, Management of Security and Privacy Incidents, as appropriate.

11. Whether credit protection services may assist record subjects in avoiding or mitigating the results of identity theft based on the sensitive personal information that may have been compromised.

12. 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 $______ 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 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.

· Necessary legal expenses the subjects may incur to repair falsified or damaged credit records, histories, or financial affairs.

16. SECURITY CONTROLS COMPLIANCE TESTING

On a periodic basis, VA, including the Office of Inspector General, reserves the right to evaluate any or all 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.

17. 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

· 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 COTR a copy of the training certificates and certification of signing the Contractor Rules of Behavior for each applicable employee within 1 week of the initiation of the contract and annually thereafter, as required.

· Failure to complete the mandatory annual training and sign the Rules of Behavior annually, within the timeframe required, is grounds for suspension or termination of all physical or electronic access privileges and removal from work on the contract until such time as the training and documents are complete.

18. GOVERNMENT RESPONSIBILITIES

· The VA Office of Security and Law Enforcement will provide the necessary forms to the contractor or to the contractor’s employees after receiving a list of names and addresses.

· Upon receipt, the VA Office of Security and Law Enforcement will review the completed forms for accuracy and forward the forms to OPM to conduct the background investigation.

· The VA Office of Security and Law Enforcement will notify the contracting officer and contractor after adjudicating the results of the background investigations received from OPM.

19. CONTRACTOR QUALIFICATIONS

Contractors performing work shall:

· Knowledge of coding and documentation concepts, guidelines, and clinical terminology.

· Ability to interpret and analyze all information in a patient’s health record, including laboratory and other test results, to identify opportunities for more precise and/or complete documentation in the heath record.

· Knowledge of anatomy and physiology, pathophysiology, and pharmacology.

· Ability to establish and maintain strong verbal and written communication with providers.

· Knowledge of regulations that define healthcare documentation requirements, including The Joint Commission, CMS, and VA guidelines.

· Knowledge of coding rules and requirements to include clinical classification systems (such as current versions of ICD and CPT), complication or comorbidity/major complication or comorbidity (CC/MCC), Medicare Severity Diagnosis Related group (MS-DRG) structure, and Present on Admission (POA) indicators.

· Knowledge of severity of illness and risk of mortality indicators.

· Knowledge of training methods and teaching skills sufficient to conduct continuing education for staff development. The training sessions may be technical in nature or may focus on teaching techniques for the improvement of clinical documentation issues.

20. QUALITY CONTROL

Contractors performing work shall:

· establish and maintain a written quality assurance and control plan to assure that the requirements of the contract are met, and that coding adheres to all rules and regulations.

· perform on-going quality assessment of not less than 5% of all coding services and provide weekly results to the facilities to ensure that 95% accuracy rate is met. Track results by Contractor to assure appropriate follow-up.

· monitor to ensure that the 95% quality standard is being met on an on-going basis. If monitoring demonstrates that work has fallen below the quality standard, the Contractor shall develop a corrective action plan and include it with the data for that week.

· re-review any coded data found questionable by the VA monitoring processes or when a denial is received. Contractor shall either make changes or substantiate the coding with appropriate coding rules and references. This activity shall be provided by the contractor at no cost to the facilities.

Contractor Internal Compliance Plan

In Accordance with the American Health Information Management Association, (AHIMA), Centers for Medicare and Medicaid Services (CMS), VHA Directive 2003-028 "Compliance and Business Integrity Program", its updates or replacement directives, HHS OIG Compliance Program Guidance for Hospitals, as published 63 FR 8987 (February 23, 1998) and HHS OIG Supplemental Compliance Program Guidance for Hospitals as published at 70 FR 4858 ( January 31, 2005) the contractor is to provide in writing their internal Compliance Program, Training and Monitoring Plans which is to include documentation of training and monitoring procedures.

Annual VHA Training

In accordance with VHA Directive 2003-028 "Compliance and Business Integrity Program", its updates or replacement directives, IG Guidance at 8994, Section II(C); Guidance at 4875, Section III (B)(4) Sentencing Guidelines, Section 8B2.1 (b) (4) (B) annual compliance training is to be provided to all contractors within the scope of their work. The medical center COTR's are to coordinate the annual training with their respective Compliance and Business Integrity Officers. A copy of the documentation of the completed annual training is to be provided to the Compliance and Business Integrity Officers for their files.

21. PROJECT MANAGER/SUPERVISOR

The Contractor shall assign a Project Manager to serve as central point of contact for the contract period. The Project Manager shall be available by telephone during normal business hours for Pacific Time. Contractor shall be responsible for providing telephone numbers and fax numbers.

22. SAFETY REQUIREMENTS

· All personnel employed by the Contractor in the performance of this contract, or any representative of the Contractor entering on VASDHS shall comply with applicable Federal, State, and VA safety and fire regulations and codes, which are in effect during the performance period of the contract.

· Contractor shall perform work in strict accordance with existing relevant, accredited standards and codes to minimize the possibility of injury to personnel, or damage to Government equipment.

· Contractor shall comply with all applicable Federal, State, and local requirements regarding workers’ health and safety. The requirements include, but are not limited to, those found in Federal and State Occupational Safety and Health Act (OSHA) statutes and regulations, such as applicable provisions of Title 29, Code of Federal Regulations (CFR), Parts 1910 and 1926, NFPA 70E, Article 130.7 29 CFR 1910.132(d)(1)(iii), 29CFR1910.137.

· Contractor shall provide all necessary tools, and Personal Protective Equipment (PPE) to perform the work safely, effectively, and timely.

· The VAMC San Diego building 1, main building, contains asbestos. Any worker entering these asbestos containing areas must have an asbestos certification of no less than 16 hours and a valid fit test certification. Certifications must be presented to the VA project manager before any work in an asbestos area may begin.

23. CHANGES

The awarded Contractor is advised that only the Contracting Officer, acting within the scope of the contract has the authority to make changes which affect the contract in terms of quality, quantity, price, or delivery. In the event the Contractor effects any such change at the direction of any person other than the Contracting Officer, the change shall be considered to have been made without authority and no adjustment shall be made in the contract price to cover any increase in costs incurred as a result thereof.

24. VA POLICY

Possession of weapons is prohibited. Enclosed containers, including tool kits, are subject to search. Violations of VA regulations may result in citations answerable in the United States (Federal) District Court.

25. PARKING POLICY

It is the responsibility of Contractor personnel to park only in designated parking areas. Parking information is available from the VA Police. The VA shall not validate or make reimbursement for parking violations of the Contractor’s personnel under any circumstances.

26. IDENTIFICATION BADGES

All Contractor personnel are required to wear identification (I.D.) badges during the entire time they are on the VA…