36C25620Q0303-001.doc

PERFORMANCE WORK STATEMENT

Substance Disorders Treatment Program

SOBER LIVING CONTRACT

26 December 2019

1 GENERAL:

1.1. GENERAL: The Contractor shall be responsible for providing “sober living” housing to 10-30 Veterans with substance use disorders who are participating in the Substance Disorders Treatment Program (SDTP) at the Department of Veterans Affairs Medical Center in Houston, TX. The goal of the contract is to facilitate recovery from substance use disorders by providing a safe, supportive place to live while Veterans engages in treatment.

1.2. BACKGROUND. The MEDVAMC provides comprehensive medical and mental health care for Veterans which, along with emergency and acute-medical and mental health inpatient care, provides outpatient care for Substance Use Disorders including case management, a range of levels of care for substance use disorder, and medication management. The contractor shall offer a safe, secure, and recovery-oriented environment and social community. The Contractor will not be required to provide detoxification or other hospital level treatment – those services will be provided by the VA at VA facilities.

1.3. Eligible Veterans served shall include Veterans diagnosed with Substance Use Disorders who are physically and mentally capable of leaving the building, unaided, in the event of an emergency and willing to comply with rules and regulations of the facility.

1.4. The Contractor may provide services and accommodations to either men or women or both as long as those services provide safety and appropriate protection of the individuals. Contractor shall ensure appropriate safety precautions are in place to reduce the risk of harm, especially with regard to women and children.

1.5. PLACE OF PERFORMANCE: All services shall be provided at the Contractor’s facility and shall be located within a 15 mile radius of the Michael E. DeBakey Veteran Affairs Medical Center (VAMC) 2002 Holcombe Boulevard, Houston TX 77030-4298

1.6. AUTHORITY: FAR Parts 12 – Acquisition of Commercial Items, FAR Part 13 Simplified Acquisition Procedures, FAR 13.5 Simplified Procedures for Certain Commercial Items, FAR 16.5 Indefinite Delivery Contracts.

1.7. POLICY AND REGULATIONS: Contractor shall comply with all applicable policy and regulations, including, but not limited to the following:

1.7.1.

Privacy Act of 1974 (5 U.S.C. 552a) as amended http://www.justice.gov/oip/foia_updates/Vol_XVII_4/page2.htm

1.7.2.

VHA Handbook 1605.1, Privacy and Release of Information http://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=1423 1.7.3.

Health Insurance and Accountability Act of 1996 (HIPAA) https://www.cms.gov/Regulations-and-Guidance/Administrative-Simplification/HIPAA-ACA/index.html

1.8. DEFINITIONS/ACRONYMS:

1.8.1.

CO: Contracting Officer

1.8.2.

COR: Contracting Officer’s Representative

1.8.3.

COS: Chief of Staff

1.8.4.

CPARS: Contractor Performance Assessment Reporting System

1.8.5.

ISO: Information Security Officer

1.8.6.

PWS: Performance Work Statement

1.8.7.

QA/QI: Quality Assurance/Quality Improvement

1.8.8.

QM/PI: Quality Management/Performance Improvement

1.8.9.

QASP: Quality Assurance Surveillance Plan 1.8.10.

Length of Stay (LOS) 1.8.11.

VA: Veterans Affairs

1.8.12.

VAMC: Veterans Affairs Medical Center

1.8.13.

VHA: Veterans Health Administration

1.9.

BILLING DEFINITIONS:

1.9.1.

Length of Stay(LOS): The LOS is the period covered by the individual Unit Price. The LOS begins on the date of admission at the Contractor’s facility and will end upon the date of discharge from the Contractor’s facility. Additional days beyond the LOS for each CLIN will be reimbursed at the daily rate prescribed on the Price Schedule for each CLIN.

2. FACILITY

2.1. It is the responsibility of the Contractor to properly maintain its facilities and the VA shall have no responsibility for paying or reimbursing the Contractor for such expenses. The contract facility must:

2.1.1 Have a current occupancy permit issued by the local and/or state governments (as appropriate) in the jurisdiction where the facility is located.

2.1.2 Be in compliance with existing standards of State safety codes and local, and/or State health and sanitation codes.

2.1.3 Certified by the National Association of Recovery Residences (for which VA will pay a premium) or registered with City of Houston as compliant with local ordinance as lodging or boarding facility as appropriate.

2.1.4 Be equipped with operational air conditioning/heating systems

2.1.5 Be kept clean, free of dirt, grime, mold, or other hazardous substances and damaged noticeably detract from the overall appearance.

2.1.6 Be equipped with first aid equipment (to include Naloxone) and posted evacuation plans in case of emergency.

2.1.7 Have windows and doors that can be opened and closed in accordance with manufacturer standards.

2.2. The contractor facility must meet fire safety requirements, as follows:

2.2.1. The building must meet the requirements of the applicable residential occupancy chapters of the current version of NFPA 101, National Fire Protection Association's Life Safety Code. Any equivalencies or variances must be approved by the appropriate Veterans Health Administration Veterans Integrated Service Network (VISN) Director.

2.2.2. All residents in the facility must be mentally and physically capable of performing their own activities of daily living and of leaving the building, unaided, in the event of an emergency.

2.2.3. Fire exit drills must be held at least quarterly. Residents must be instructed in evacuation procedures when the primary and/or secondary exits are blocked. A written fire plan for evacuation in the event of fire shall be developed and reviewed annually. The plan shall outline the duties, responsibilities and actions to be taken by the staff and residents in the event of a fire emergency. This plan shall be implemented during fire exit drills.

2.2.4. Conduct an Emergency Disaster Evacuation Drill and submit corresponding Plan to SDTP Program Director, SDTP Sober Living Contract Liaison, or designee annually.

2.2.5. A written policy regarding tobacco smoking in the facility shall be established and enforced.

2.2.6. Portable fire extinguishers shall be installed at the facility. Use NFPA 10, Portable Fire Extinguishers, as guidance in selection and location requirements of extinguishers.

2.2.7. Requirements for fire protection equipment and systems shall be in accordance with NFPA 101. All fire protection systems and equipment, such as the fire alarm system, smoke detectors, and portable extinguishers, shall be inspected, tested and maintained in accordance with the applicable NFPA fire codes and the results documented.

2.2.8. The annual inspection by a VA team required by paragraph 7 shall include a fire and safety inspection conducted at the facility unless a review of past Department of Veterans Affairs inspections or inspections made by the local authorities indicates that a fire and safety inspection would not be necessary, in which case the fire and safety inspection may be waived by the VA.

2.3. The contractor facility must develop Integrated Pest Management Plan (IPM)

2.3.1. The purpose of an IPM Program is to forestall or prevent infestation, and to control or eliminate existing infestation.

2.3.2. Preventive pest management is considered to be the most economical and effective means of protecting our patients, employees, visitors and Government property.

2.3.3. An optimum program depends on the cooperation of all personnel. A facility memorandum on this subject should be issued stating responsibilities and procedures necessary for a successful program. In addition, a pest management information program should be given to all personnel and it should identify responsible program officials, including their titles, location, phone numbers.

2.3.4. Recording and Reporting. All pest management operations, to include all

2.3.5. chemical and non-chemical work, are to be recorded and reported and such records maintained for the VA inspections. As a minimum, records must show the:

(1) Date of service.

(2) Target pest.

(3) Location of the specific room, area, or building where the work is performed.

(4) Operational activity or function; e.g., baiting, spraying, dusting, trapping, mechanical, structural.

(5) Pesticide used.

(6) EPA registration number of the pesticide.

(7) Percentage of mix used in dilution.

(8) Amount of pesticide used expressed in pounds of active ingredient.

(9) Applicator or operator and the applicator’s certification identity.

2.4. INSPECTION OF FACILITY AND PROGRAM.

2.4.1. Prior to contract award and annually during the contract term, a multidisciplinary VA team consisting of a social worker, dietitian, registered nurse, a representative of the VA Police, and a Facilities Management Safety Officer, and other subject matter experts as determined necessary by the medical center director or SDTP Sober Living Contract Liaison shall conduct a survey of the Contractor’s facilities to assure the facility functions in an effective and safe manner. Inspections may also be carried out at such other times as deemed necessary by the Department of Veterans Affairs.

2.4.2. The contractor will be advised of the findings of the inspection team. If deficiencies are noted during any inspection, the contractor will be given a reasonable time to take corrective action and to notify the Contracting Officer that the corrections have been made. A contract will not be awarded until noted deficiencies have been eliminated. Failure by the Contractor to take corrective action within a reasonable time will be reported to the VA Contracting Officer. If corrections are not made to the satisfaction of the VA, the Contracting Officer will consult with the appropriate officials so that suitable arrangements can be made to discontinue plans to award a contract, or to discharge or transfer patients and to terminate the existing contract, as appropriate

2.4.3. The inspection of the Contractor facilities will include inspection for conformity to the current Life Safety Code and will also include the following:

2.4.3.1 General observation of residents to determine if they maintain an acceptable level of personal hygiene and grooming.

2.4.3.2 Assessment of whether the facility meets applicable fire, safety and sanitation standards.

2.4.3.3 Determining whether the facility is in attractive surroundings conducive to social interaction and the fullest development of the resident's rehabilitative potential.

2.4.3.4 Observation of facility operations to see if appropriate organized activity programs are available during waking hours (including evenings) and degree to which a high level of activity is observed in the facility.

2.4.3.5 Seeking evidence of facility-community interaction, demonstrated by the nature of scheduled activities or by information about resident flow out of the facility, e.g., community activities, volunteers, local consumer services, etc.

2.4.3.6 Observation of staff behavior and interaction with residents to determine if they convey an attitude of genuine concern and caring.

2.4.3.7 Inspecting the meals, types of snacks or other occasional food consumed by residents to see if it is provided in a setting which encourages social interaction and if nutritious snack options between meals and bedtime are available for those requiring or desiring additional food, when it is not medically contraindicated.

2.4.3.8 Making a spot check of veterans’ records to ensure accuracy with respect to veterans’ orientation to facility, individual goal-setting, progress towards goals, length of stay and discharge status/plan.

2.4.3.9 All Department of Veterans Affairs reports of inspection of residential facilities shall, to the extent possible, be made available to all government agencies charged with the responsibility of licensing or otherwise regulating or inspecting such institutions.

2.4.3.10 Quarterly reports identifying the agency’s current performance metrics along with quarterly surveys from veterans enrolled in the program are required to be submitted to the VA SDTP Program Director, SDTP Sober Living Contract Liaison, or designee.

2.5. Hours of Operation:

2.5.1. Services shall be available from the contractor 24 hours per day, seven days per week, including weekends and federal holidays. Contractor must provide coverage for all required shifts, including nights, weekends and holidays. Sunday through Saturday includes federal holidays as outlined in the next paragraph.

2.5.2. Federal Holidays: The following holidays are observed by the Department of Veterans Affairs:

1. New Year’s Day

2. Washington’s Birthday

3. Martin Luther King’s Birthday

4. Memorial Day

5. Independence Day

6. Labor Day

7. Columbus Day

8. Veterans Day

9. Thanksgiving

10. Christmas

11. Any day specifically declared by the President of the United States to be a national holiday.

3. CONTRACTOR RESPONSIBILITIES:

3.1 The Contractor shall furnish each Veteran referred for care under this contract with the following basic services:

3.1.1. HOUSING: Room to include a bed and other furnishings such as a dresser, storage, and personal linens (towels and bed sheets). Veterans shall have access to handicapped accessible rooms as indicated. The facility will provide hands on attention to Veterans needs that are of a social or mental health nature that do not require the skilled care services of a nursing home facility. Veterans must have access to an operable, non-pay telephone in a private location, both to make and receive personal calls.

3.1.2. LAUNDRY FACILITIES: On site Laundry facilities for residents to do their own laundry or to have laundry done.

3.1.3. RECOVERY ORIENTED SUPPORT:

(1) Written structure for recovery housing (house orientation, rules to include resident observation of curfew, expectations around abstinence violation/relapse and consequences of violation of such, grievance policy, and requirement of participation in MEDVAMC Substance Disorders Treatment Program).

(2) Weekly recovery support meetings and life skills building including financial responsibility, cooking (if applicable), volunteering, personal hygiene/grooming, and successfully reintegrating into the job market.

(3) Supervision and recovery support for the residents at recovery homes. Staff cultivate the resident’s sense of belonging and responsibility for community.

(4) Data collection (conditions of discharge, relapse rates, engagement in productive activities including employment/education) with expectation of developing benchmarks and standards for successful performance on relevant dimensions negotiated between contractor and VA.

(5) Weekly individual goal-setting meeting and a peer-to-peer community based structure of recovery.

(6) Coordination with VA program staff which will provide therapeutic and psychosocial services on-site at MEDVAMC.

(7) Residents engage in governance and leadership.

(8) Contractor staff model prosocial behavior and relationship enhancement skills.

3.1.4. NUTRITIONAL SUPPORT

Contractor will either provide meals and/or assure processes are in place such that Veterans have access to groceries, equipment, structure, training and/or oversight (as needed) to enable meal preparation appropriate to satisfy nutritional needs.

3.1.5. MEDICATION STORAGE

Medication will be stored by the Veteran in a locked cabinet, drawer or other locked storage container. Duplicate keys for the Veteran’s Locked storage container and room must be available to the veteran and the administrator, on-site manager or designated staff.

3.1.6. Case records shall be maintained in security and confidence as required by the Health Insurance Portability and Accountability Act (HIPAA). Contractor shall comply with applicable requirements of the Confidentiality of Alcohol and Drug Abuse Patient Records (42 CFR Part II) and the Confidentiality of Certain Medical Records (38 USC 7332).

3.1.7. The contractor shall comply with the principles listed in 38 CFR 17.707(b) to provide housing and supportive services in a manner that is free from religious discrimination.

3.1.8 SUPPLEMENTAL SERVICES. All services shall be provided at no additional charge to the stated daily fixed fee. Contractor may have the capacity to perform point of care testing for substances of misuse to be administered at the discretion of the contractor.

3. ADDITIONAL CONTRACT REQUIREMENTS

4.1. The Contractor will employ sufficient personnel to carry out the policies, responsibilities, and the program for the facility. There must be, as a minimum, at least one administrative staff member, or designee of equivalent professional capability, on duty on the premises or residing at the house and available for emergencies 24 hours a day, 7 days a week.

4.2. The Contractor shall assign to this contract personnel that by education and training (and, when required, certification or licensure) are qualified to provide the Basic Services and Supplemental Services required by this SOW.

4.3. The Contractor must identify each person functioning as “Key Personnel” under this contract, and provide to the VA a description of the duties of such person, together with a resume summarizing that person’s relevant skills and experience.

4.4. During the first ninety (90) calendar days of contract performance, the Contractor shall make NO substitutions of key personnel unless the substitution is necessitated by illness, death, or termination of employment. Within 14 days after substitutions necessitated by situations described above, the Contractor shall provide resumes for the substitute key personnel. For substitutions proposed by the Contractor after the initial 90 calendar day period, the Contractor shall provide resumes for the substitute personnel, together with any other additional information requested by the Contracting Officer, at least 15 days before the substitution is to occur. The Contracting Officer shall notify the Contractor within fifteen (15) calendar days after receipt of all required information if the VA refuses to accept the substitute key personnel. The VA reserves the right to refuse or revoke acceptance of key personnel if personal or professional conduct, or lack of required skills or experience, jeopardizes patient care or interferes with the regular and ordinary operation of the facility.

4.5 Temporary substitutions of key personnel shall be permitted in accordance with the Contractor’s contingency plan. The Contractor’s contingency plan to be utilized if personnel leave Contractor’s employment or are unable to continue performance in accordance with the terms and conditions of the resulting contract must be submitted as part of the Contractor’s offer.

4.6 All Contractor staff providing support to Veterans under this contract must undergo the appropriate background investigation as required by the VA. Before receiving an initial referral of Veterans under the contract, the Contractor shall submit a listing of all Contractor personnel proposed to provide services to Veterans under the contract. The VA will provide the necessary background information forms to the Contractor or to the Contractor’s employees after receiving a list of names and addresses.

4.6.1 The VA Contracting Officer shall forward the completed background investigations to the Office of Security and Law Enforcement for adjudication. The Office of Security and Law Enforcement shall notify the Contracting Officer and Contractor after adjudicating the results of the background investigations received from the investigating office.

4.6.2. The COR shall be responsible for verifying that investigations have been completed or are in the process of being requested before Veterans are referred to the Contractor’s facilities.

4. REFERRALS

5.1. The VA is responsible for determining eligibility of Veterans prior to referral to the Contractor for treatment. A written MEDVAMC SDTP “Sober Living Authorization Voucher” (hard copy, fax or e-mail are acceptable) signed by an authorized VA ordering officer shall be provided to the Contractor for each Veteran referred for services under the contract.

5.2. The Contractor will have the option to conduct additional screening of VA eligible Veterans to maximize appropriate placement based on Contractor’s available services. Any Veteran deemed inappropriate for admission will require a written rationale from Contractor.

5.3. It is understood that the Contractor will not be paid for care provided to a referred Veteran beyond the period authorized in the referral, unless an extension of the authorization is provided in writing by the VA.

5.4. The initial referral period for a Veteran may be up to ninety days, depending upon the needs of the Veteran as mutually determined by the Veteran and the Contracting Officer’s Representative (COR). An extension of the referral period up to a total of 6 months may be authorized by the COR,provided that funding is available. Treatment periods in excess of 6 months for individual Veterans must be authorized by the COR.

6. ABSENCES AND CANCELLATION – (GPD Leave of Absence Rule)

6.1. The Contractor shall notify the VA of unauthorized absences by a referred Veteran from the facility no later than the next business day. A Veteran who is absent without approval from Contractor with no expectation to return may be discharged after 24 hours and the appropriate exit form must be completed. Should a Veteran absent himself/herself from the Contractor’s facility payment for services for that Veteran “can” be continued for a maximum period of ”72-hours,” provided there is an active outreach attempt on the part of the Contractor’s staff to return the Veteran to the facility and there is a reasonable belief that the Veteran will return. The Contractor may authorize Veteran a 72 hour up to 14 day leave of absence for clinically appropriate reasons; however, the Contractor can only bill for the first 72 hours. The Contractor has the option of discharging the Veteran after the first 72 hours if the bed is not being held for the Veteran. Even if the provider holds the bed open for the Veteran, the Contractor must discharge the Veteran after the 14th day of absence. When and if the Veteran returns after the 14th day, it is considered a separate episode of care and the Veteran must reappear on the given months admission list. If the Veteran has an approved absence and returns to the program in less than 14 days, there is no need to readmit the Veteran. However, the Contractor can only bill for 3 of those absent days (first 72 hours). The next consecutive 11 days will be considered no bill. Management of program dropout will be an element of quality assurance review of this program.

6.2. VA reserves the right to remove any or all Veterans from the facility at any time, without additional cost, when it is determined to be in the best interest of the VA or the Veteran.

6.3. The Contractor shall notify the authorizing VA facility immediately when a medical or mental health emergency occurs that requires hospitalization of a referred Veteran. It is agreed that the Veteran will be admitted to the appropriate VA facility. When such admission is not feasible because of the nature of the emergency, it is agreed that hospitalization in a non-federal hospital may be accomplished provided that VA authorization is obtained. If hospitalization of a non-emergency nature is required it is agreed that admission to the appropriate VA facility will be accomplished promptly. Contractor is required to provide a copy of Standard Operating Procedures for handling patients with psychotic/suicidal patients behavior immediately to the (COR.

6.4. The Contractor shall notify the authorizing VA facility immediately of any incidents involving veterans residing in the residential program. The Contractor shall notify the COR and VA case manager by telephone during the hours of 8:00am and 4:30pm. For all incidents that occur after normal business hours, the Contractor should notify the MEDVAMC Administrator on Duty (AOD) @ (713) 791-1414. The Contractor shall provide the SDTP Contract Liaison and the COTR with a copy of the incident report within 24 hours. The contractor shall maintain a copy of the incident report in the Veteran’s case record.

7. CONTRATOR STAFF CONDUCT/COMPLAINTS HANDLING

7.1. Contractor personnel shall be expected to treat referred Veterans with dignity and respect and abide by standards of conduct mirroring those prescribed by current federal personnel regulations. The Contractor shall comply with the VA Patient's Bill of Rights as set forth in 38 CFR 17.34a (copy available upon request).

7.2. The VA reserves the right to exclude Contractor staff members from providing services to Veterans under this contract based on breaches of conduct, including conduct that jeopardizes patient care or interferes with the regular and ordinary operation of the facility. Breaches of conduct include intoxication or debilitation resulting from drug use, theft, patient abuse, dereliction or negligence in performing directed tasks, or other conduct resulting in formal complaints by Veterans or other staff members to designated Government representatives. The Contractor and Contracting Officer’s Technical Representative shall deal with issues raised concerning contractor personnel conduct. The Contracting Officer shall be the final arbiter on questions of acceptability and in validating complaints.

8 TRANSPORTATION

Contractor shall provide Veterans with information regarding public transportation and/or assist with coordination of VA provided transportation services for follow-up appointments at the VA. VA will pay a premium for contractors who provide transportation for Veterans to and from appointments with SDTP for Intensive Outpatient Programming.

9. CONTRACT CHANGES/TECHNICAL DIRECTIONS.

The Contracting Officer is the only person authorized to approve changes or modify any of the requirements of this contract. The Contractor shall communicate with the Contracting Officer on all matters pertaining to contract administration. Only the Contracting Officer is authorized to make commitments or issue changes that shall affect price, quantity or quality of performance of this contract.

In the event the Contractor Affects any such change at the direction of any person other than the Contracting Officer without authority, no adjustment shall be made in the contract price to cover an increase in costs incurred as a result thereof.

The COR will be responsible for the overall technical administration of this contract as outlined in the COR Delegation of Authority, including monitoring of the Contractor’s performance.

1.1. CONTRACTOR Security Requirements (HAndbook 6500.6)

VA information and information system security/privacy

1. 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.

2. Access to VA information and VA information systems

a. 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.

b. All contractors, subcontractors, and third-party servicers and associates working with VA information are subject to the same investigative requirements as those of VA appointees or employees who have access to the same types of information. The level and process of background security investigations for contractors must be in accordance with VA directive and handbook 0710, personnel suitability and security program. The office for operations, security, and preparedness is responsible for these policies and procedures.

c. Contract personnel who require access to national security programs must have a valid security clearance. National industrial security program (NISP) was established by executive order 12829 to ensure that cleared u.s. defense industry contract personnel safeguard the classified information in their possession while performing work on contracts, programs, bids, or research and development efforts. The Department of Veterans Affairs does not have a memorandum of agreement with Defense Security Service (DSS). Verification of a security clearance must be processed through the special security officer located in the planning and national security service within the office of operations, security, and preparedness.

d. Custom software development and outsourced operations must be 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.

e. The contractor or subcontractor must notify the contracting officer immediately when an employee working on a VA system or with access to VA information is reassigned or leaves the contractor or subcontractor's employ. The contracting officer must also be notified immediately by the contractor or subcontractor prior to an unfriendly termination.

3. VA information custodial language

a. Information made available to the contractor or subcontractor by VA for the performance or administration of this contract or information developed by the contractor/subcontractor in performance or administration of the contract shall be used only for those purposes and shall not be used in any other way without the prior written agreement of the VA. This clause expressly limits the contractor/subcontractor's rights to use data as described in rights in data - general, far 52.227-14(d) (1).

b. VA information should not be co-mingled, if possible, with any other data on the contractors/subcontractor's information systems or media storage systems in order to ensure VA requirements related to data protection and media sanitization can be met. If co-mingling must be allowed to meet the requirements of the business need, the contractor must ensure that VA’s information is returned to the VA or destroyed in accordance with VA’s sanitization requirements. VA reserves the right to conduct on site inspections of contractor and subcontractor it resources to ensure data security controls, separation of data and job duties, and destruction/media sanitization procedures are in compliance with VA directive requirements.

c. Prior to termination or completion of this contract, contractor/ subcontractor must not destroy information received from VA, or gathered/ created by the contractor in the course of performing this contract without prior written approval by the VA. Any data destruction done on behalf of VA by a contractor/subcontractor must be done in accordance with national archives and records administration (NARA) requirements as outlined in VA directive 6300, records and information management and its handbook 6300.1 records management procedures, applicable VA records control schedules, and VA handbook 6500.1, electronic media sanitization. Self-certification by the contractor that the data destruction requirements above have been met must be sent to the VA contracting officer within 30 days of termination of the contract.

d. The contractor/subcontractor must receive, gather, store, back up, maintain, use, disclose and dispose of VA information only in compliance with the terms of the contract and applicable federal and VA information confidentiality and security laws, regulations and policies. If federal or VA information confidentiality and security laws, regulations and policies become applicable to the VA information or information systems after execution of the contract, or if NIST issues or updates applicable FIPS or special publications (SP) after execution of this contract, the parties agree to negotiate in good faith to implement the information confidentiality and security laws, regulations and policies in this contract.

e. The contractor/subcontractor shall not make copies of VA information except as authorized and necessary to perform the terms of the agreement or to preserve electronic information stored on contractor/subcontractor electronic storage media for restoration in case any electronic equipment or data used by the contractor/subcontractor needs to be restored to an operating state. If copies are made for restoration purposes, after the restoration is complete, the copies must be appropriately destroyed.

f. If VA determines that the contractor has violated any of the information confidentiality, privacy, and security provisions of the contract, it shall be sufficient grounds for VA to withhold payment to the contractor or third party or terminate the contract for default or terminate for cause under federal acquisition regulation (FAR) part 12.

g. If a VHA contract is terminated for cause, the associated baa must also be terminated and appropriate actions taken in accordance with VHA handbook 1600.01, business associate agreements. Absent an agreement to use or disclose protected health information, there is no business associate relationship.

h. The contractor/subcontractor must store, transport, or transmit VA sensitive information in an encrypted form, using VA-approved encryption tools that are, at a minimum, FIPS 140-2 validated.

i. The contractor/subcontractor's firewall and web services security controls, if applicable, shall meet or exceed VA’s minimum requirements. VA configuration guidelines are available upon request.

j. Except for uses and disclosures of VA information authorized by this contract for performance of the contract, the contractor/subcontractor may use and disclose VA information only in two other situations: (i) in response to a qualifying order of a court of competent jurisdiction, or (ii) with VA’s prior written approval. The contractor/subcontractor must refer all requests for, demands for production of, or inquiries about, VA information and information systems to the VA contracting officer for response.

k. 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.

l. 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.

4. Information system design and development

a. 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 PIA.

b. 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.

c. 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.

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 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.

f. 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.

g. 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 specifically identifies:

(a) the systems of records (SOR); and

(b) the design, development, or operation work that the contractor/ subcontractor is to perform;

(1) 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

(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 SOR.

h. 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.

(1) "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.

(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 particular 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 name of the individual or by some identifying number, symbol, or other identifying particular assigned to the individual.

i. The vendor shall ensure the security of all procured or developed systems and technologies, including their subcomponents (hereinafter referred to as "systems"), throughout the life of this contract and any extension, warranty, or maintenance periods. This includes, but is not limited to workarounds, patches, hotfixes, upgrades, and any physical components (hereafter referred to as security fixes) which may be necessary to fix all security vulnerabilities published or known to the vendor anywhere in the systems, including operating systems and firmware. The vendor shall ensure that security fixes shall not negatively impact the systems.

j. 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 3 days.

k. 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.

l. 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.

5. Information system hosting, operation, maintenance, or use

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

b. Adequate security controls for collecting, processing, transmitting, and storing of personally identifiable information (PII), as determined by the VA privacy service, must be in place, tested, and approved by VA prior to hosting, 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 of the documentation (PIA, system security plan, contingency plan). The certification program office can provide guidance on whether a new C&A would be necessary.

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 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.

f. 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.

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;

(a) The equipment vendor must have an existing baa if the device being traded in has sensitive information stored on it and hard drive(s) from the system are being returned physically intact; and

(b) Any fixed hard drive on the device must be non-destructively sanitized to the greatest extent possible without negatively impacting system operation. Selective clearing down to patient data folder level is recommended using VA approved and validated overwriting technologies/methods/tools. Applicable media sanitization specifications need to be pre-approved and described in the purchase order or contract.

(c) A statement needs to be signed by the director (system owner) that states that the drive could not be removed and that (a) and (b) controls above are in place and completed. The ISO needs to maintain the documentation.

6. Security incident investigation

a. 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.

b. To the…