Q999--Peritoneal Home Care Program


Subject: Q999--Peritoneal Home Care Program
Solicitation Number: 36C24721Q0842
Notice Type: SRCSGT
NAICS: 621610
Notice Published: 06-10-21
Response Due: 06-15-21

Agency: Department of Veterans Affairs
Office: VETERANS AFFAIRS, DEPARTMENT OF
Contact: Benford C Brundage, Same as above This email address is being protected from spambots. You need JavaScript enabled to view it. Ph: (334) 727-0550
Office Address: AUGUSTA, GA 30904
Place of Performance: Birmingham VA Medical Center 700 19th St S., Birmingham, AL 35233


Click for official SAM (FBO) notice, additional information, and accompanying attachments

REQUEST FOR INFORMATION (RFI) Peritoneal Dialysis Home Care Services THIS IS NOT A REQUEST FOR PROPOSALS, NOR A REQUEST FOR QUOTATIONS; IT IS STRICTLY A REQUEST FOR INFORMATION (RFI). NO CONTRACT WILL BE AWARDED PERSUANT TO THIS ANNOUNCEMENT. SUBJECT: The Birmingham VA Medical Center, (Birmingham, AL), is conducting market research for Peritoneal Dialysis Home Care Services to be utilized by the imaging department. Any vendor questions regarding this RFI are requested by 8:00 am EST on Jun 14, 2021 to allow sufficient time for the Government to respond. Vendor responses to this RFI are due by 1:00 pm EST on June 15, 2021. DISCLAIMER: This RFI is issued solely for informational and planning purposes and does not constitute a solicitation. Responses to this notice are not offers and will not be accepted by the Government to form a binding contract. Any information provided in response to this RFI will be considered and treated as unrestricted information which can be used by the Government in any future planning or acquisitions. The Government does not anticipate awarding or modifying a contract in response to this RFI. All information comments and suggestions determined to be beneficial to the Government may be incorporated into future acquisition documents or contracts, without identifying the source or obtaining prior approval from the source. The Government shall not be responsible or liable for any costs incurred by any party in the preparation and submission of any response to this RFI. All information received in response to this RFI marked as "proprietary" will be handled accordingly. Information provided in response to this RFI will not be returned. The Government does not guarantee that any resultant acquisition action will result from this RFI. BACKGROUND: The Department of Veterans Affairs requires a contractor shall furnish all necessary supplies and equipment for Peritoneal Dialysis (PD) as prescribed for medical center use and direct delivery to beneficiaries of the Birmingham VA Medical Center, Birmingham, Alabama. The contractor is responsible for delivering all supplies under this contract directly to the beneficiary's location, as requested. This service will be for a base year plus four one-year options. This RFI is an invitation to submit to the Acute & Subspeciality Care Department the following: Technical information and all related supporting documentation. Please provide detailed submitted responses. These responses will be directly related to the current, and subject to change, salient characteristics/statement of work/performance work statement as specified below along with any supporting technical literature. Responses must be straightforward, clear, concise, and specific to the information requested. Response to this RFI must be submitted via email to Benford Cortez Brundage at This email address is being protected from spambots. You need JavaScript enabled to view it.. E-mail responses should be no larger than 5 megabytes (MB) in size. Please include a point of contact, phone number, e-mail address, and website information. STATEMENT OF WORK & REQUIREMENTS Description of Services/Supplies: Contractor shall furnish all necessary supplies and equipment for Peritoneal Dialysis (PD) as prescribed for medical center use and direct delivery to beneficiaries of the Birmingham VA Medical Center, Birmingham, Alabama. The contractor is responsible for delivering all supplies under this contract directly to the beneficiary's location, as requested. Contractor shall: Coordinate with the Home Peritoneal Dialysis Service at the Birmingham VAMC to obtain required forms Provide delivery of all supplies to patients wherever they are physically located in the United States, including when patient is traveling Safeguard any patient information received as listed specifically in general section below. Contact each patient to ensure patient has received supplies Contact each patient to ensure supplies are adequate for the month or until next shipment arrives Guarantee on time delivery of all ordered supplies Price per patient monthly bundle/kit which will be one blanket price per kit regardless of contents. Supply quality products free from defects or recall. Provide bundle/kit tailored to specific patient s needs. It may include all or any combination of the products listed below as ordered by the Home Peritoneal Dialysis Service clinical staff. Note: As new products become available, list of products may change if discussed with Home Peritoneal Dialysis Service and Contracting Officer (CO). VA Clinical Staff shall: Notify contractor for new patient starts or need to put supplies on hold for patient condition/situation. Request sheet (Patient name, address, phone number, social security number, DOB, dialysis start date and provider NPI#), patient prescription and patient demographics sheet is faxed to contractor at time of request. Educate patients on peritoneal dialysis and determine follow-up schedule for patients per local/national guidelines. Communicate with contractor if supplies are missing or defective. Communicate with Maria Small with any negative trends in performance or quality of supplies. Point of Contact (POC) The Point of Contact (POC) will be determined at time of award. POC will provide Home Peritoneal Dialysis Service/Contractor the yearly obligation number for direct delivery beneficiaries. The contractor shall use the appropriate assigned obligation number for the months on all correspondence and invoices until new obligation number is assigned for the next option year is exercised IAW the contract. Direct Deliveries: Home Peritoneal Dialysis Service will contact the contractor by telephone and give a yearly obligation number for direct delivery beneficiaries. The contractor shall use the appropriate assigned obligation number for the year on all correspondence and invoices. When a VA beneficiary is accepted into the program to receive direct delivery of PD supplies, the patient s prescription is faxed to the contractor with product name and quantities along with the patient s clinical intake form/demographic sheet. Information requested from the contractor must be limited to only the information essential to perform the service/delivery of supplies. It shall be the contractor's responsibility to coordinate with Home Peritoneal Dialysis Service (205) 933-8101 ext. 6515 regarding the patient's authorized prescribed inventory levels and establish delivery schedules. The contractor shall contact the patient monthly (or as needed) to verify patient's requirements and set up delivery order. In the event a patient needs additional supplies after the monthly order is placed, the patient may contact the contractor via telephone and the contractor may use the mailing system to get supplies to the patient. The contractor is responsible for adhering to all mailing requirements in this matter. (Supply List Attached). Packing and Marking: All containers are to be marked with the expiration date. All products must provide not less than an eighteen Month expiration date. Cases are to be clearly marked, specifying content and handling methods. Qualifications: Offeror shall be the manufacturer or authorized dealer for the manufacturer of the product for which a quote will be provided. Shipping: All orders shall be shipped F.O.B. Destination, by common carrier, standard delivery within 3 to 5 days ARO (After Receipt of Order). The cost of any other designated shipping options (i.e., overnight, 2nd day, etc.) by the Birmingham VAMC payment of such shall be the responsibility of the Birmingham V. Contractor shall prepay and add to invoice. Note: The POC will assess the charges and coordinate with the COR for additional payment. Performance Monitoring: Clinical staff from Birmingham VA will follow-up with patient to ensure they have received necessary supplies. Clinical staff will notify Lisa Pollock, Contracting Officer Representative (COR) of patient s receipt of items, missing supplies, delays in shipment or any performance issues of the contractor or supplies. 8. Period of Performance: The period of performance is a base plus four years contract beginning on the date the contract is initiated. 9. Type of Contract: Firm fixed price for all materials are noted in the attachment with the exception of prescription medications. Quantity of materials used or ordered will vary by patient according to their needs. Supply List Description Unit Estimated Annual Usage 1 PERSONAL CYCLER CARRYING CASE EA 1 EA 2 AMIA CYCLER LEASE EA 1 EA 3 AMIA APD CASSETTE 30/CS 13 CS (390 EA) 4 APD DRAIN MANIFOLD 30/CS 13 CS (390 EA) 5 12 FOOT DRAIN EXTENSION SET 30/CS 13 CS (390 EA) 6 CYCLER DRAINAGE SET (CS 15 PR) 30/CS 26 CS (780 EA) 7 MINI-CAP, DISCONNECT W/PVP-1 S SOLUTION 60/CS 7 CS (420 EA) 8 EFFLUENT SAMPLE BAG 6/CS 1 CS (6 EA) 9 ULTRA CLAMP 12/CS 1 CS (12 EA) 10 PERM EQUIPMENT - VALKITCL EA 1 EA 11 STAY SAFE/LUER LOCK ADAPTER 12 DIANEAL LOW CA 1.5% DEX 3L/3L 4/CS 24 CS (96 EA) 13 DIANEAL LOW CA 1.5% DEX 6L/6L 2/CS 183 CS (366 EA) 14 DIANEAL LOW CAL 1.5% DEX 2L/2L UB 6/CS 1 CS (6 EA) 15 DIANEAL LOW CAL 2.5% DEX 2L/2L UB 6/CS 2 CS (12 EA) 16 DIANEAL LOW CAL 2.5% DEX 3L/3L 4/CS 24 CS (96 EA) 17 DIANEAL LOW CAL 2.5% DEX 6L/6L 2/CS 183 CS (366 EA) 18 DIANEAL LOW CAL 4.25% DEX 2L/2L UB 6/CS 1 CS (6 EA) 19 DIANEAL LOW CAL 4.25% DEX 3L/3L 4/CS 1 CS (4 EA) 20 DIANEAL LOW CAL 4.25% DEX 6L/6L 2/CS 1 CS (2 EA) 21 DIANEAL PD2 1.5% DEX 2L/2L UB 6/CS 22 DIANEAL PD2 1.5% DEX 3L/3L 4/CS 23 DIANEAL PD2 1.5% DEX 6L/6L 2/CS 24 DIANEAL PD2 2.5% DEX 2L/2L UB 6/CS 25 DIANEAL PD2 2.5% DEX 3L/3L 4/CS 26 DIANEAL PD2 2.5% DEX 6L/6L 2/CS 27 DIANEAL PD2 4.25% DEX 2L/2L UB 6/CS 28 DIANEAL PD2 4.25% DEX 3L/3L 4/CS 29 DIANEAL PD2 4.25% DEX 6L/6L 2/CS 30 ANTIBACTERIAL HAND SOAP EA 10 EA 31 FACE MASKS ISOLATION EAR LOOP 50/BX 15 BX (750 EA) 32 GAUZE SPONGE 4X4 25/TR 30 TR (750 EA) 33 HAND SANITIZER GEL ANIOSGEL EA 10 EA 34 PD BELT 3/CS 12 CS (36 EA) 35 SPONGE,IV,2X2,6PLY,STERILE, NON-WOVEN 20/TR 19 TR (380 EA) 36 VANCOMYCIN 1 GM VIAL EA 10 EA 37 CEFAZOLIN 1 GM VIAL EA 10 EA 38 CEFTAZIDIME 1 GM VIAL EA 5 EA 39 STERILE WATER 10 ML VIAL EA 15 EA 40 NEEDLES 21G X 1" 100/BX 1 BX 41 3 CC SYRINGES 100/BX 1 BX 42 10CC SYRINGES 100/BX 1 BX 43 HEPARIN (1000 UNITS/ML) 10 ML VIAL EA 36 EA 44 PAPER TAPE 1 INCH 12/BX 6 BX (72 EA) 45 ALCOHOL PREP PADS 200/BX 1 BX (200 EA) Extraneal (icodextran) PD solutions 7.5% Fill volume 2000ml Container size 2000ml 6/case 1 case Extraneal (icodextran) PD solution, Ultrabag System 7.5% Icodextran: Fill volume 2500ml Container size 3000ml 5/case 1 case Extraneal (icodextran) PD solution, Luer Single bag (Ambu- FlexII 7.5% Fill Volume 2000ml, Container size 2000ml 6/case 1 case Extraneal (icodextran) PD solution, Luer Single bag (Ambu- FlexII 7.5% Fill Volume 2500ml, Container size 3000ml 5/case 1 case Security Appendix B and C MARCH 12, 2010 VA HANDBOOK 6500.6 APPENDIX B VA Handbook 6500.6 Appendix Clause: VA Acquisition Regulation Solicitation Provision and Contract Clause (October 2008) SUBPART 839.2 Information and Information Technology Security Requirements 839.201 Contract clause for Information and Information Technology Security Due to the threat of data breach or loss of information that resides on either VA-owned or contractor-owned systems, and to comply with federal laws and regulations, VA has developed an Information and Information Technology Security clause. To be used when VA information is used, stored, generated, transmitted, or exchanged by and between VA and a contractor, subcontractor or a third party in any format (e.g., paper, microfiche, electronic or magnetic portable media). In solicitations and contracts where VA Information and/or Information Technology will be accessed or utilized, the contracting officer shall insert the clause found at 852.273-75, Security Requirements for Unclassified Information Technology Resources 852.273-75 - Security Requirements for Unclassified Information Technology Resources (interim- October 2008) As prescribed in 839.201, insert the following clause: The contractor and their personnel shall be subject to the same Federal laws, regulations, standards and VA policies as VA personnel, regarding information and information system security. These include, but are not limited to Federal Information Security Management Act (FISMA), Appendix III of OMB Circular A-130, and guidance and standards, available from the Department of Commerce s National Institute of Standards and Technology (NIST). This also includes the use of common security configurations available from NIST s Web site at: http://checklists.nist.gov To ensure that appropriate security controls are in place, Contractors must follow the procedures set forth in VA Information and Information System Security/Privacy Requirements for IT Contracts located at the following Web site : http://www.iprm.oit.va.gov/Security_and_Privacy_Requirements_for_Contractors.asp MARCH 12, 2010 VA HANDBOOK 6500.6 APPENDIX C VA INFORMATION AND INFORMATION SYSTEMS SECURITY/PRIVACY LANGUAGE 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 Privacy Impact Assessment. 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; (2) 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 (3) 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, hot-fixes, 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 twenty (20) 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 than twenty (20) 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 pro...