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PRODUCT DESCRIPTION (PD) TEMPLATEDEPARTMENT OF VETERANS AFFAIRSInfection Prevention and Control, Office of Quality, Safety and ValueClinical Software Surveillance and Database Management SystemDate: 8/15/2019TAC-19-51539PD Version Number: 2.1Contents TOC \o "1-4" \h \z \u 1.0PRODUCT REQUIREMENTS PAGEREF _Toc16672284 \h 31.1MINIMUM SALIENT CHARACTERISTICS FOR COMMERCIAL OFF-THE-SHELF (COTS) SOFTWARE: PAGEREF _Toc16672285 \h 31.2VA CLOUD REQUIREMENT PAGEREF _Toc16672286 \h 201.2.1VAEC HOSTING PAGEREF _Toc16672287 \h 201.2.2CONTRACTOR HOST CLOUD ENVIRONMENT PAGEREF _Toc16672288 \h 211.2.2.1ASSESSMENT, AUTHORIZATION, and CONTINUOUS MONITORING PAGEREF _Toc16672289 \h 211.2.2.2FEDRAMP REQUIREMENT PAGEREF _Toc16672290 \h 221.3GRAY MARKET GOODS PAGEREF _Toc16672291 \h 222.0NOTICE OF THE FEDERAL ACCESSIBILITY LAW AFFECTING ALL INFORMATION AND COMMUNICATION TECHNOLOGY (ICT) PROCUREMENTS?(SECTION 508) PAGEREF _Toc16672292 \h 232.1SECTION 508 – INFORMATION AND COMMUNICATION TECHNOLOGY (ICT) STANDARDS PAGEREF _Toc16672293 \h 232.2COMPATABILITY WITH ASSISTIVE TECHNOLOGY PAGEREF _Toc16672294 \h 242.3ACCEPTANCE AND ACCEPTANCE TESTING PAGEREF _Toc16672295 \h 243.0INFORMATION TECHNOLOGY USING ENERGY-EFFICIENT PRODUCTS PAGEREF _Toc16672296 \h 244.0SHIPMENT OF HARDWARE OR EQUIPMENT PAGEREF _Toc16672297 \h 254.1SPECIAL SHIPPING INSTRUCTIONS PAGEREF _Toc16672298 \h 265.0GENERAL REQUIREMENTS PAGEREF _Toc16672299 \h 265.1VA TECHNICAL REFERENCE MODEL PAGEREF _Toc16672300 \h 265.2POSITION/TASK RISK DESIGNATION LEVEL(S) PAGEREF _Toc16672301 \h 265.3TRAVEL PAGEREF _Toc16672302 \h 27APPENDIX A – REQUIRED DATA ELEMENTS PAGEREF _Toc16672303 \h 27INFORMATION SECURITY CONSIDERATIONS: PAGEREF _Toc16672304 \h 41PRODUCT REQUIREMENTSThe requirement is for a comprehensive clinical surveillance technology and data management system/products that interfaces with existing data resources, for example, Veterans Health Information Systems and Technology Architecture (VistA), Computerized Patient Record System (CPRS), PICIS, Bed Management, and Bar Code Medication Administration (BCMA) and has the flexibility/scalability to interface with systems not yet established (e.g., Cerner) to provide real time data and predictive analytics to enhance clinical decision making. The system/products shall allow multiple users (at least 25 users) to simultaneously access and utilize multiple data resources to filter real-time data to create alerts, determine appropriate treatment or care algorithms, conduct queries, and pull a variety of information related to the following: on-going clinical surveillance and monitoring of healthcare associated infections, influenza, emerging infectious diseases and antibiotic resistance trends, daily alerts, trending, analysis, documenting, and reporting to support mission critical activities within the Infection Prevention and Control (IPC), Pharmacy, Antimicrobial Stewardship Program (ASP) and Quality and Safety programs (QS) at VA Palo Alto Health Care System (VAPAHCS).The Contractor shall provide product whose technologies support clinical surveillance, provides data management, optimizes a decision support system utilizing real time data, and streamlines multidisciplinary, multilevel, facility wide efforts for infection prevention and control and antimicrobial stewardship.MINIMUM SALIENT CHARACTERISTICS FOR COMMERCIAL OFF-THE-SHELF (COTS) SOFTWARE:ParameterAttribute1License/subscription shall provide real-time clinical surveillance, decision support, for documenting, alerting, querying, and reporting of critical lab values, diagnostic results, healthcare associated infections, influenza, emerging infectious diseases, antibiotic usage, antibiotic resistance, drug bug mismatches, pharmacological therapies. Solution shall be available at VA Palo Alto Health Care System, which includes: Palo Alto Division, Livermore Division, Menlo Park Division, andCommunity Based Outpatient Clinics (CBOCs) at San Jose, Capitola, Monterey, Fremont, Modesto, Stockton and Sonora.Product delivery, installation and functional user capabilities (active use) to occur within 90 days of purchase. (Please see Appendix A: Required Data Elements)The Period of Performance shall be 12 months with four 12-month option periods.2User friendly product shall interface with multiple data sources, to access Health Level 7 (HL7) data and data elements not available via HL7 to include: VistA and non-VistA domains:(See Appendix A: Required Data Elements)(CPRS and Cerner-electronic medical/health records, Patient demographicsIntensive care unit real-time database (PICIS Critical Care Suite)BCMA (Bar Coded Medication Administration)Pharmacy all data sources for inpatient and outpatient, medication administration and prescribing, prescribing providersAdmission/Discharge/Transfer data,Scanned documents from outside laboratories, diagnostic reports and imaging, procedural reportsBed management system, VAPAHCS locations,Laboratory, pathology, microbiology, non-microbiology infection-related labs, PCR -based labs, serology, cytology, chemistry, virology, epidemiology, PCR-based labs, immunology, positive cultures. Outpatient laboratories/ Anesthesiology data in VistA and PICISAntimicrobial cost dataER notes, vital signs, procedural/imaging reports/results, VistA imagesData from all locations in the VA Palo Alto Health Care System and outside healthcare facilitiesVA and VHA data in the Corporate Data WarehouseVISN 21 data sourcesCustom alerts/queries/reports/lists shall be shared with other team members with similar/shared roles and appropriate access. (See Appendix A for the roles and access requirements) Examples of reports would include: Lists of patients on isolation precautions, identified diagnosis/disease for management, (and bed location), patient demographic information, medications of interest, with positive lab/microbiology cultures, critical lab results, HAI, anticoagulation therapy, diseases reportable to public health department, Catheter Associated Urinary Tract Infections (CAUTI), Central line Associated Blood Stream Infections (CLABSI), Blood Stream Infections (BSI), Carbapenem-resistant Enterobacteriaceae (CRE), Dialysis Access and Infections, Vascular Access Device Infections, Ventilator Associate Events (VAE), Methicillin-resistant Staphylococcus Aureus (MRSA), Multi-drug Resistant Organisms (MDRO), Clostridium difficile (C. difficile or C. diff), Legionella, Tuberculosis (TB), Surgical Site Infections (SSI) based on current ICD coding, Influenza, unusual organisms, and emerging pathogens; high risk medications, non-formulary medications, medication usage for inpatient and outpatient, medication adherence, non-microbiology infection -related labs, antibiograms, antimicrobial utilization, compliance reports for hand hygiene, precautions surveillance.Contractor shall provide VA Data Mapping attributes for the application (i.e. mapping which data domains/elements are being imported/utilized from which VHA sources), as a reference for future trouble-shooting and creation of additional reports/queries. The intent of this deliverable is to create:A VA Data Mapping Guide, in a binder and/or electronic book format that describes how and where the product accesses the required data elements to create the various queries/reports.A User Guide, in a binder and/or electronic format that will serve as a user resource manual, such that the “Super-Users would access to train new users post the Go-Live date.*Note: These 2 resource guides may be completed within 120 days from product purchase.Deliverables:VA Data Mapping GuideUser GuideFunctionalityFlexibilityScalabilityCorrectnessReliabilitySecurityEfficiencySafetyIntegrityTestabilityMaintainabilityInteroperabilityExtensibility3Contractor shall provide professional services for the completion of the following tasks: Activities necessary to establish a Project Management team who shall manage, oversee, and support software implementation/set-up/deployment, training, end-user trainings, “Go-Live”, train the trainer, including installation, configuring, mapping and integration, interface establishment, testing, data validation, mentoring, ongoing data extractions, creating user-friendly quick reference guide for data mapping, data flow, and created reports and various custom dashboards. Go-Live date should be within 90 days of award.Contractor shall provide professional services to ensure full function and sustainability of product for each option year.FunctionalityFlexibilityScalabilityCorrectnessReliabilitySecurityEfficiencySafetyIntegrityTestabilityMaintainabilityInteroperabilityExtensibility4Contractor shall provide 24/7 maintenance (including testing, trouble shooting, equipment repair/fix/patches, new equipment, new product/software versions, services and contractor enhancements (not VA directed enhancements).Contractor shall provide training to “Super-users” of any changes or product enhancements (i.e., new versions or features) that impact product use. These trainings or updates may be in the form of an electronic message, on-line meeting, Skype, or webinar.If enhancements are significant to constitute major changes (e.g., changes in functionality; user interface/navigation; customized features) then a new user guide will need to be provided.ReliabilitySecuritySafetySustainability5Contractor shall provide professional services to ensure the completion of training for new users. Contractor shall train the first group of new users. This group of approximately 25-30 individuals will receive face-to face, hands on computer, “train the trainer” type training onsite at the VA Palo Alto Health Care System location (3801 Miranda Avenue, Palo Alto, CA), prior to the 90 days “Go-Live” targeted date. VA will provide computers for the training participants for the hands-on training. These users will, then, be able to provide trainings as needed to other users who require training beyond the “Go-Live” date. Contractor to work with identified point of contact or designated Contracting Officer Representative (COR) for this requirement to coordinate trainings. Base year new user Train-the-Trainer trainings shall be conducted by the Contractor, on site, face-to-face for new user specialty/job function (for example, Infection Prevention and Control, Antimicrobial Stewardship Program and Pharmacy).The Contractor may organize trainings by service/group/specialty, use, or function.Contractor hosted trainings, other than this initial training, (for example, product new features or enhancements, see item #4) may be via online capabilities with live presenter. (i.e Skype, or Webinar). Contractor shall provide all training materials and presentations to the COR.Deliverable:Training Materials and Presentations, to include PowerPoint presentations and other materials (media) are due upon training.6Product shall support the ability for onsite VA Palo Alto Health Care System (VAPAHCS) identified point of contacts to have administrative rights for adding/removing users and establishing users’ roles and permissions. (See Appendix A: User Characteristics and Role-Based Access)FunctionalityInteroperability FlexibilitySecurity 7Product shall be integrated with VA-based security/PIV card access to facilitate log-in. (Due 90 days post award). FunctionalityInteroperability FlexibilitySecurity8Product shall interface and be accessed via VA-issued mobile devices (e.g. iPads, laptops, iPhones/other smart phones) as well as on desktop computers. (Due 90 days post award).FunctionalityInteroperability FlexibilitySecurity9Product shall include functions/tools to build custom alerts, rounding/audit/survey instruments, lists, queries, data dashboards, other custom dashboards and reports for Infection Prevention and Control team’s clinical surveillance, tracking, trending, query, and analysis needs. All reports shall be exportable. Parameters or algorithms for reports shall be easily customized by user and have ability to drill down for greater detail/specificity (See Appendix A: Required Data Elements) (Due 90 days post award)The functions/tools shall provide the capabilities to build the following reports:Catheter Associated Urinary Tract Infections (CAUTI), Central line Associated Blood Stream Infections (CLABSI), Blood Stream Infections (BSI), Carbapenem-resistant Enterobacteriaceae (CRE), Dialysis Access and Infections, Vascular Access Device Infections, Ventilator Associate Events (VAE), Methicillin-resistant Staphylococcus Aureus (MRSA), Multi-drug Resistant Organisms (MDRO), Clostridium difficile (C. difficile or C. diff), Legionella, Tuberculosis (TB), Surgical Site Infections (SSI) based on current ICD coding, Influenza, unusual organisms, and emerging pathogens. Hospital Acquired/Associated Infections (HAI)Positive cultures and critical lab results Notifiable and reportable diseases/public health reporting Isolation orders/patient identification and location as indicated in CPRS orders, compared to PCR or culture-based data (e.g. presence/absence of appropriate isolation order in a patient who has tested positive for MRSA in nasal swab PCR; identification of patients without appropriate screening rectal PCR for CRE, e.g. in a patient who has been on CRE precautions/had a CRE isolation order in the past year and is now readmitted).Patient demographics and bed status/locationsAbility to identify, track clusters/outbreaks, patients and patient transfers within and out of VAPAHCS.FunctionalityExtensibilityInteroperability FlexibilitySecurity Scalability10Product shall leverage technology to transform current paper-based rounding/audit/survey instruments, lists, education/training provided and attendance sheets to electronic format (for example, a database) for documentation, querying, tracking for corrections/remedy and aggregating program operational activities for dashboard (See Appendix A: Required Data Elements) (Due 120 days post award)Rounding areas included:Sterile Processing Supplies (SPS) – Canteen Rounds – document location, findings, time spent and track action plans for remedyPublic Health Reporting - MDRO template auditsConstruction and Infection Control Risk Assessment (ICRA) Matrix – document and record construction auditsEducation – document education topic, date, time, training length in minutes, and by whom provided by Infection Prevention and Control (IPC) staff. 11Shall include functions/tools to build custom alerts, rounding/audit/survey/surveillance instruments, lists, queries, custom dashboards, and reports for the Antimicrobial Stewardship Program. (See Appendix A: Required Data Elements) (Due 90 days post award)Product shall interface with VistA and non-VistA domains. VistA domains required include the following packages: CPRS’ text/note dataMicrobiology lab and all laboratory data including, but not limited to, non-microbiology infection-related labs (e.g. lab-chem items like procalcitonin, PCR-based labs, serologic labs), outpatient laboratoriesPharmacy and BCMA data, ADT (admission/discharge/transfer data),Vital signsProcedures/imaging performed, ER data, Data from non-Palo Alto VAPAHCS stations (e.g. community living/long-term care units at Menlo Park, Livermore VAs). Data from interface with non-Vista domains required includes, but, is not limited to: intensive care unit real-time database (PICIS Critical Care Suite), anesthesiology data in VistA/PICIS. This includes the capability of scanning/accessing documents/data (e.g. VistA images, linked PDFs from CPRS) such as those scanned in by the microbiology laboratory to record outside microbiology test results (e.g. coccidioides serologies from University of California at Davis, fungal susceptibilities) or OR/PACU records. Inpatient prospective auditing of antimicrobial utilization with immediate up-to-date reporting on patients on targeted, pre-specified individual and sets of antimicrobials and antimicrobials identified based on algorithm queries. This will include but not be limited to:Pre-specified broad-spectrum, costly, ‘high-risk’, or ‘salvage’ antimicrobials of interestPre-specified antimicrobials eligible for “de-escalation,” Pre-specified antimicrobials eligible for intravenous to oral conversions based on not only the antimicrobial name/class but also culture parameters, Antimicrobials ordered for certain pre-specified indications in ‘indications’ field of prescription, Antimicrobials currently being prescribed that have potential interactions with other concurrently-prescribed drugs, and Antimicrobials prescribed in the setting of drug-bug mismatch.Antimicrobial Stewardship Intervention logging, tracking and monitoring within the product interface, with line item data as well as easy-to-export graphics/charts/tables, including cost avoidance savings (e.g. creating analysis/output on cost avoidance savings when various interventions are linked with specific cost savings). Tracking of Antimicrobial Stewardship Intervention performed within the electronic medical record (optional): This would optimally involve, in order to retrospectively capture and report on interventions logged into the chart, the ability to query/search patient CPRS chart note titles for audit of interventions and workload capture, i.e. to search for notes specifically titled “Antimicrobial Approval Request Review”.Detailed reports on diseases of interest, such as a C difficile report incorporating patient classification (hospital-acquired, community-onset, microbiology/chemistry laboratory data, ward, and date of admission/days since admission) using NHSN definitions, epidemiologic patient characteristics (age, gender, comorbidities, ward, service, attending physician), and important clinical data/test result, preceding antibiotics in the prior 30-90 days, prior episode of identified disease onset and prior same disease test results, concurrent antibiotics, concurrent proton-pump inhibitors or probiotic prescriptions, and ID involvement as marked by Infectious Diseases note and/or consult order within a given timeframe. For catheter-associated urinary tract infections (CAUTI) information, data would include ward, date of admission, attending provider/service (ADT data), ordering provider for positive urine culture, patient demographics, microbiology and urinalysis data, and optimally CPRS note/note title data (“Foley Catheter removal/placement note” title extraction), specific ICD10/problem list codes (paraplegia/tetraplegia/spinal cord injury) and antibiotics prescribed in a discrete period (e.g. 7 days) prior to and after the culture. For catheter/line-associated bloodstream infections (CLABSI), data would include ward, date of admission, attending provider/service (ADT data), ordering provider for positive blood culture, patient demographics, microbiology data including blood cultures and other concurrent (urine within 3 days, respiratory cultures), and optimally CPRS note/note title data (“Central Line” removal/placement notes). Exportable tables and charts/graphs representing data in reports. Antimicrobial utilization, measured in days of therapy (DOT) per 1000 patient days or days present, for all locations, including nursing home areas. This must include the ability to narrow, trend, filter accurately based on service, ward, and provider, identifying totals and individual utilization trends for location/personnel/service groups. Must include long-term and custom-date retrospective data on antimicrobial use (>3 years) to evaluate antimicrobial utilization trends over time, and to evaluate the impact of various policy, formulary, personnel/staffing, service changes and interventions on antimicrobial trends, cost, and utilization. Prospective analysis of such trends allows for analysis of the impact of new CPRS order set/algorithm or intervention implementation. Active real-time audit and alerting of multiple providers to both inpatient and outpatient infections of interest; Provide real-time identification and alerts of patients:Microbiology alerts: This includes, but is not limited to: positive blood cultures, Clostridium difficile PCR and BioFire GI Panel results for C difficile, Legionella culture and urine antigen for Legionellosis, procalcitonin (chemistry), carbepenemase-resistant Enterobacteriaceae (CRE), other resistant organisms of interest (customizable/mutable over time), Vancomycin-resistant enterococcus (VRE), panels of infections related to bioterrorism, and infections that are highly transmissible. Non-microbiology alerts (e.g. serology like positive coccidioidomycosis serology titer or syphilis test). Create an accurate and consistent antibiogram using 1st isolate methodology (as defined by the Clinical and Laboratory Standards Institute (CLSI)) for VAPAHCS, required at least annually but recommended more frequently. Create location specific antibiograms: Ability to create facility-wide cumulative antibiograms and inpatient-ward-wide antibiograms, unit-specific antibiograms, and antibiograms for grouped units, including but not limited to: separate and combined acute care/intensive care/surgical units, spinal cord injury (SCI) units, long term care areas including long-term care units at Palo Alto (Bldg. 100, 4C) and non-Palo Alto community living centers (CLCs) at Livermore Division and Menlo Park Division, outpatient antibiogram, emergency department.Specimen type/site-specific antibiogram, for example antibiogram that separates respiratory from non-respiratory organisms in the ICU, separates urinary and non-urinary isolates of E. coli, or has overall urinary vs. non-urinary isolate antibiogram. Combination antibiograms (e.g. all non-enteric gram negatives, such as Pseudomonas aeruginosa and Acineter baumannii combined; or carbapenem-resistant enterobacteraciae (CRE) combined)Analysis of vancomycin MIC over current year and prior 3 years for Staphylococcus aureus (recorded in susceptibility section of microbiology results) to evaluate for MIC trends, including reviewing all S. aureus isolates, as well as MRSA and non-MRSA separately. Potential to capture/include susceptibilities for antimicrobial agents listed in “comments” under microbiology culture results entered manually, in addition to those entered electronically/via Vitek, including daptomycin, aztreonam, penicillin and ceftriaxone meningitis/non-meningitis MICs for Streptococcus pneumoniae, and any other susceptibilities entered manually (e.g. results of VAPAHCS laboratory Kirby-Bauer testing for specially-requested antimicrobials by searching on key terms, e.g. “ceftaroline” for methicillin-resistant Staphylococcus aureus). Some newer antibiotics, especially, are not yet included in automated Vitek testing/results and the lab techs add susceptibility testing for these on by request or by protocol. Ability to exclude data from “test” patients (mock patients). Monitoring and analysis of antimicrobial resistance trends over time, with the ability to trend historically at least 3 years. Historical data is needed to create/compare antibiograms.Historical data to perform medication use evaluations (MUEs) to assess our use of antimicrobials at VAPAHCS over time. 11. Monitoring and analysis of negative effects of antibiotics, including mortality trends by service/ward, C. difficile rates by service/ward, and antimicrobial adverse events. The latter will require search/audit of entries in the medical record notes on adverse events reporting (e.g. ADR note) as well as allergy field entries. In order to capture potentially unreported adverse reactions, the tool should have the potential capability to grow to allow for query of specific laboratory results or key words in combination with administration of various antibiotics (e.g. search for increase in transaminase labs or serum creatinine beyond a certain level/threshold in patients on trimethoprim/sulfamethoxazole). 12. Perform customized queries to address/analyze specific questions to optimize antimicrobial prescribing practices and assess the impact of interventions, policies, and/or implementation of order menus. Examples of this may be: evaluation of impact on prescribing, laboratory, and infection trends after discontinuation of a policy of routine testing/treatment of asymptomatic bacteruria that occurred within a surgical clinic last year; or impact on C difficile rates after change in perioperative antibiotic protocols or changes in formulary; or 3-month mortality rates, antibiotic duration, C difficile and perioperative infection rates after change in an antibiotic-prescribing algorithm is made. This would require integration of data components that are:diagnosis-specific by ICD-10 population-specific by various epidemiologic factors (comorbidities, gender, age group)location-specific (e.g. outpatient, emergency department, intensive care unit, acute inpatient wards, nursing home areas, operating room) or primary service-specific. This should include intensive care unit parameters and data included in the PICIS system, as well as optimally anesthesia data and ER data. lab result or culture-specificorganism-specific or resistance-pattern-specificPotential to generate individual patient-level ID summary reports, e.g. for rounding or for follow-up of all inpatient individual patients on antimicrobials or with certain antimicrobial-related adverse effect (e.g. patients diagnosed today with C difficile), for example comprised of a patient profile and summary, including patient name and demographic/ward information, current vital signs, today’s labs, recent microbiology data and recent antimicrobials or cumulative (e.g. prior 6 months) antimicrobials doses/dates summary. Ideally could create this “ID summary” page/report on a patient ad hoc (e.g. by typing in their name/identifiers, generating report) but also by adding name to a list (e.g. a rounding list for providers, pharmacists with a known list of patients to round on each day). Functionality, Flexibility, and Scalability, Extensibility,InteroperabilityTransferability12Shall include functions/tools to build custom alerts, auditing/surveillance tools, queries, custom dashboards, and reports for the Pharmacy Services. Parameters or algorithms for reports shall be easily customized by user and have ability to drill down for greater detail/specificity. (See Appendix A: Required Data Elements) (Due 90 days post award)Reports to include various data: disease of interest, co-morbidities, high risk medications, medications of interest, non-formulary medications, inpatient and outpatient utilization of medications (especially antimicrobials, HIV antiretrovirals, higher than recommended doses of statin, and anticoagulants), laboratory and pathology results patient demographics, ICD coding, and medication adherence/refill patterns.13Shall include functions/tools to build custom reports and data dashboards for Intervention documentation with automated cost and savings data for all programs/services utilizing the product.Reports to include: intervention, cost, savings, return on investment (ROI), productivity reporting by clinician of type and number of interventions.Clinicians/users shall be able to get data and format desired by individual, clinician, or departments/services.14Rounding/surveillance/audit tools shall provide single view access to multiple data sources of patient demographics integrated with alerts, calculated values and trending. Access to detailed information shall be able to be drilled down from summary.Note sections for treatment directions, care or other follow up type messages shall be included.15Shall provide the ability to access (e.g. de-identified) data from VISN21, in addition to Palo Alto Health Care System data, in order to compare/analyze utilization and resistance patterns of our facility compared to regional facilities, for trend analysis, and for pathogen/outbreak identification. (See Appendix A: Required Data Elements) (Due within120 days post award)And ability to aggregate and transmit reports and data electronically to required health agencies, such as the Centers for Disease Control and Prevention (CDC), and/or National Healthcare Safety Network (NHSN). Tables, charts and graphs shall be exportable using common standard formats (e.g., CVS, Excel, or PDF).Functionality, Flexibility, Scalability, Extensibility,InteroperabilityTransferability16Product shall be able to analyze a minimum historical data of >3 years in order to obtain trends, evaluate effects of prior interventions/policies/changes in practice, query long-term data for analysis (e.g. C difficile rates, analyze unusual pathogens that may not occur frequently and thus require long-term look-back) and monitor long-term susceptibility patterns. See Appendix A: Required Data Elements) (Due within 90 days post award) Functionality, Scalability,Extensibility,Interoperability17The software will support installation/loading within a virtual environment and/or hosted on the VA Cloud and operate within the Veterans Health Administration Enterprise Architecture, Veterans Health Information Systems and Technology Architecture (VistA), and other existing Veterans Affairs (VA) IT components and equipment.FunctionalityCorrectnessReliabilitySecurityEfficiencySafetyIntegrityFlexibilityScalabilityTestabilityMaintainability18Contractor to define and provide a 3-tiered level of customer service responsiveness Help Desk, such that customer needs are prioritized and met.ReliabilityEfficiencySustainabilityVA CLOUD REQUIREMENTThe Contractor may provide the Clinical Software Surveillance and Database Management System hosting through the VA Enterprise Cloud (VAEC) environment or as a Software-as-a-Service (Saas). The requirements for VAEC and SaaS are identified below:VAEC HOSTINGIn November 2018, VA issued the Cloud First Policy mandating that all new and existing IT solutions be assessed to determine suitability to be offered as an enterprise cloud computing service. The VA Enterprise Cloud (VAEC) was established by the Enterprise Cloud Solutions Office (ECSO) in 2017, to host cloud computing solutions. The Clinical Software Surveillance and Database Management system shall be implemented and hosted in the VA Enterprise Cloud and adhere to the VA Enterprise Cloud Technical Reference Guide, Version 1.3 July 2018.The Contractor’s Clinical Surveillance & Data Management System solution shall be hosted in the VAEC environment and be fully functional no later than 90 days after contract award. The Contractor shall not be responsible for providing or acquiring cloud capacity or server hosting infrastructure for this contract. VA will furnish VAEC capacity as Government Furnished Equipment (GFE). The Government will provide the following GFE:Cloud capacity in and connectivity to the VA Enterprise Cloud (VAEC) environments.VA Enterprise Cloud Operational Tools (VAECOT) comprised of a suite of COTS cloud management tools as identified in the VAEC Technical Reference GuideEnterprise Development Environment (EDE) and Tools as identified in the VAEC Technical Reference GuideThe Contractor shall:Support setup, configuration, and provisioning of the solution in the VAEC environments.Work with VA to provide inputs for establishing VAEC capacity, accounts and privileges. This includes monitoring and tracking the creation, update, and deletion of application user (e.g., developer, systems administrator) accounts, and ensuring cloud capacity requirements are satisfied.Develop necessary artifacts to obtain a VA authority to operate (ATO) for the solution and complete VA Assessment and Authorization (A&A) process. After ATO is achieved, the Contractor shall update and maintain the A&A documentation as required to ensure continued compliance. The Contractor shall monitor, track, and respond to Plan of Action and Milestones (POAM). The Contractor shall provide input to update the VAEC ATO, as needed.Provide for the backup and recovery of information stored by the solution to meet the application and VAEC SLA using native tools and capabilities of the VAEC environmentProvide a Quarterly Solution Performance Report that summarizes solution availability, usage, events and incidents, improvement opportunities, risks and issues, status, action plans, and planned and actual resolution timelines.Review all usage of cloud computing services provided by VAEC. The Contractor shall submit and implement Quarterly Resource Utilization Optimization Plans on how to best optimize the environment to reduce the costs associated with resource utilization.Provide a breakdown of all costs by solution, environment, and utilization. The Contractor shall report on utilization of each class of resource as a percentage of provisioned capacity in a Monthly Utilization Report. The Contractor shall, as part of its Monthly Utilization Report, include the total infrastructure expenditure and total number of request services for Cloud Resource Optimization.Deliverables: Due within the 180 days (6 months) from Receipt of Order (ARO)Quarterly Solution Performance ReportQuarterly Resource Utilization Optimization PlanMonthly Utilization ReportCONTRACTOR HOST CLOUD ENVIRONMENTThe Contractor shall meet the following requirements for a Contractor hosed cloud environment solution:ASSESSMENT, AUTHORIZATION, and CONTINUOUS MONITORINGThe information system solution selected by the Contractor shall comply with the Federal Information Security Management Act (FISMA).The Contractor shall comply with FedRAMP requirements as mandated by Federal laws and policies, including making available any documentation, physical access, and logical access needed to support this requirement. Following guidance from the Federal CIO, VA will utilize existing JAB ATO or agency ATO issued by another agency as a starting point for FedRAMP requirements. If neither of those exist, VA will sponsor FedRAMP ATO. VA will be using the FedRAMP baselines as a starting point, since they are specifically tailored for cloud services. The Contractor solution shall meet the requirements outlined in Office of Management and Budget Memorandum M08-05 mandating Trusted Internet Connections (TIC) (), M08-23 mandating Domain Name System Security (NSSEC) (), and shall comply with the Trusted Internet Connections (TIC) Reference Architecture Document, Version 2.0 HYPERLINK "" \o "Link to TIC Reference Architecture Document" Contractor shall, where applicable, assist with the VA Authority to Operate (ATO) Process to help achieve agency authorization of the cloud service or migrated application including delivering Assessment & Authorization (A&A) ATO Package Artifacts and Plan of Action and Milestones (POAM).The Contractor shall afford VA access to the Contractor’s and Cloud Service Provider’s facilities, installations, technical capabilities, operations, documentation, records, and databases. If new or unanticipated threats or hazards are discovered by either VA or the Contractor, or if existing safeguards have ceased to function, the discoverer shall immediately bring the situation to the attention of the other party in accordance with the security Addendum B.The Contractor shall not release any data without the consent of VA in writing. All requests for release must be submitted in writing to the COR/CO.Deliverables: Due within 7 days from Receipt of Order (ARO)A&A ATO Package ArtifactsPlan of Action and Milestones FEDRAMP REQUIREMENTThe Clinical Software Surveillance and Database Management System shall be hosted on a FedRAMP-{Impact (Confidentiality - High, Integrity- High, Availability-Moderate) certified cloud solution. The Contractor shall provide a copy of the certificate issued granting Authority to Operate the cloud provider that is hosting the Clinical Software Surveillance and Database Management System. The Contractor shall maintain its security authorization throughout the contract period of performance. Deliverable: Due within 7 days from Receipt of Order (ARO)A.FEDRAMP {FedRamp Security Impact Level} Certification GRAY MARKET GOODSThe Contractor must provide only new equipment and new parts for the required products described herein; no used, refurbished, or remanufactured equipment or parts shall be provided under any circumstances. Absolutely no “Gray Market Goods” or “Counterfeit Electronic Parts” shall be provided. Gray Market Goods are defined as genuine branded goods intentionally or unintentionally sold outside of an authorized sales-territory or by non-authorized dealers in an authorized territory. All equipment shall be accompanied by the Original Equipment Manufacturer’s (OEM’s) warranty. Counterfeit Electronic Parts are defined as unlawful or unauthorized reproduction, substitution, or alteration that has been knowingly mismarked, misidentified, or otherwise misrepresented to be an authentic, unmodified electronic part from the original manufacturer, or a source with the express written authority of the original manufacturer or current design activity, including an authorized aftermarket manufacturer. Unlawful or unauthorized substitution includes used electronic parts represented as new, or the false identification of grade, serial number, lot number, date code, or performance characteristics.NOTICE OF THE FEDERAL ACCESSIBILITY LAW AFFECTING ALL INFORMATION AND COMMUNICATION TECHNOLOGY (ICT) PROCUREMENTS?(SECTION 508)On January 18, 2017, the Architectural and Transportation Barriers Compliance Board (Access Board) revised and updated, in a single rulemaking, standards for electronic and information technology developed, procured, maintained, or used by Federal agencies covered by Section 508 of the Rehabilitation Act of 1973, as well as our guidelines for telecommunications equipment and customer premises equipment covered by Section 255 of the Communications Act of 1934. The revisions and updates to the Section 508-based standards and Section 255-based guidelines are intended to ensure that information and communication technology (ICT) covered by the respective statutes is accessible to and usable by individuals with disabilities.SECTION 508 – INFORMATION AND COMMUNICATION TECHNOLOGY (ICT) STANDARDSThe Section 508 standards established by the Access Board are incorporated into, and made part of all VA orders, solicitations and purchase orders developed to procure ICT. These standards are found in their entirety at: . A printed copy of the standards will be supplied upon request.?Federal agencies must comply with the updated Section 508 Standards beginning on January 18, 2018. The Final Rule as published in the Federal Register is available from the Access Board: . The Contractor shall comply with “508 Chapter 2: Scoping Requirements” for all electronic ICT and content delivered under this contract. Specifically, as appropriate for the technology and its functionality, the Contractor shall comply with the technical standards marked here: FORMCHECKBOX E205 Electronic Content – (Accessibility Standard -WCAG 2.0 Level A and AA Guidelines) FORMCHECKBOX E204 Functional Performance Criteria FORMCHECKBOX E206 Hardware Requirements FORMCHECKBOX E207 Software Requirements FORMCHECKBOX E208 Support Documentation and Services RequirementsCOMPATABILITY WITH ASSISTIVE TECHNOLOGYThe standards do not require installation of specific accessibility-related software or attachment of an assistive technology device. Section 508 requires that ICT be compatible with such software and devices so that ICT can be accessible to and usable by individuals using assistive technology, including but not limited to screen readers, screen magnifiers, and speech recognition software.ACCEPTANCE AND ACCEPTANCE TESTINGDeliverables resulting from this solicitation will be accepted based in part on satisfaction of the Section 508 Chapter 2: Scoping Requirements standards identified above.The Government reserves the right to test for Section 508 Compliance before delivery. The Contractor shall be able to demonstrate Section 508 Compliance upon Deliverables resulting from this solicitation will be accepted based in part on satisfaction of the Section 508 Chapter 2: Scoping Requirements standards identified above.The Government reserves the right to test for Section 508 Compliance before delivery. The Contractor shall be able to demonstrate Section 508 Compliance upon RMATION TECHNOLOGY USING ENERGY-EFFICIENT PRODUCTSThe Contractor shall comply with Sections 524 and Sections 525 of the Energy Independence and Security Act of 2007; Section 104 of the Energy Policy Act of 2005; Executive Order 13834, “Efficient Federal Operations”, dated May 17, 2018; Executive Order 13221, “Energy-Efficient Standby Power Devices,” dated August 2, 2001; and the Federal Acquisition Regulation (FAR) to provide ENERGY STAR?, Federal Energy Management Program (FEMP) designated, low standby power, and Electronic Product Environmental Assessment Tool (EPEAT) registered products in providing information technology products and/or services. The Contractor shall ensure that information technology products are procured and/or services are performed with products that meet and/or exceed ENERGY STAR, FEMP designated, low standby power, and EPEAT guidelines. The Contractor shall provide/use products that earn the ENERGY STAR label and meet the ENERGY STAR specifications for energy efficiency. Specifically, the Contractor shall:Provide/use ENERGY STAR products, as specified at products (contains complete product specifications and updated lists of qualifying products). Provide/use the purchasing specifications listed for FEMP designated products at . The Contractor shall use the low standby power products specified at . Provide/use EPEAT registered products as specified at . At a minimum, the Contractor shall acquire EPEAT? Bronze registered products. EPEAT registered products are required to meet the technical specifications of ENERGY STAR, but are not automatically on the ENERGY STAR qualified product lists. The Contractor shall ensure that applicable products are on both the EPEAT Registry and ENERGY STAR Qualified Product Lists.The Contractor shall use these products to the maximum extent possible without jeopardizing the intended end use or detracting from the overall quality delivered to the end user. The following is a list of information technology products for which ENERGY STAR, FEMP designated, low standby power, and EPEAT registered products are available: Computer Desktops, Laptops, Notebooks, Displays, Monitors, Integrated Desktop Computers, Workstation Desktops, Thin Clients, Disk DrivesImaging Equipment (Printers, Copiers, Multi-Function Devices, Scanners, Fax Machines, Digital Duplicators, Mailing Machines)Televisions, Multimedia ProjectorsThis list is continually evolving, and as a result is not all-inclusive.SHIPMENT OF HARDWARE OR EQUIPMENTInspection: DestinationAcceptance: DestinationFree on Board (FOB): DestinationShip To and Mark For:PrimaryAlternateName:Name:Address:Address:Voice:Voice:Email:Email:SPECIAL SHIPPING INSTRUCTIONSPrior to shipping, Contractor shall notify Site POCs, by phone followed by email, of all incoming deliveries including line-by-line details for review of requirements.? The Contractor shall not make any changes to the delivery schedule at the request of Site POC.Contractors shall coordinate deliveries with Site POCs before shipment of <hardware> hardware to ensure sites have adequate storage space.All shipments, either single or multiple container deliveries, shall bear the VA IFCAP Purchase Order number on external shipping labels and associated manifests or packing lists.? In the case of multiple container deliveries, a statement readable near the VA IFCAP PO number shall indicate total number of containers for the complete shipment (e.g. “Package 1 of 2”), clearly readable on manifests and external shipping labels.Packing Slips/Labels and Lists shall also include the following:IFCAP PO #: ____________ (e.g., 166-E11234 (the IFCAP PO number is located in block #20 of the SF 1449))Project Description: (e.g. Tier I Lifecycle Refresh)Total number of Containers:? Package ___ of ___.? (e.g., Package 1 of 3)GENERAL REQUIREMENTSVA TECHNICAL REFERENCE MODELThe Contractor shall support the VA enterprise management framework. In association with the framework, the Contractor shall comply with OI&T Technical Reference Model (VA TRM). The VA TRM is one component within the overall Enterprise Architecture (EA) that establishes a common vocabulary and structure for describing the information technology used to develop, operate, and maintain enterprise applications. Moreover, the VA TRM, which includes the Standards Profile and Product List, serves as a technology roadmap and tool for supporting OI&T. Architecture & Engineering Services (AES) has overall responsibility for the VA TRM.POSITION/TASK RISK DESIGNATION LEVEL(S)In accordance with VA Handbook 0710, Personnel Security and Suitability Program, the position sensitivity and the level of background investigation commensurate with the required level of access for the following tasks within the PWS are:Position Sensitivity and Background Investigation Requirements by Service Task/Item NumberService Task/Item NumberTier1 / Low RiskTier 2 / Moderate RiskTier 4 / High Risk1.1 FORMCHECKBOX FORMCHECKBOX FORMCHECKBOX 1.2 FORMCHECKBOX FORMCHECKBOX FORMCHECKBOX TRAVELThe government anticipates travel expenses for planned site visits. Justification for travel is to be provided to COR for approval. Travel expenses to not exceed $20,000 for base year and $7000 for option years.Travel shall be in accordance with the Federal Travel Regulations (FTR) and requires advanced concurrence by the COR.? Contractor travel within the local commuting area will not be reimbursed.APPENDIX A – REQUIRED DATA ELEMENTSRequired Data Elements for Surveillance: (Required elements noted here shall be implemented within the 90 days from Receipt of Order (ARO)Table 1 – Required Data Elements for InfectionsInfection typeRequired Data Elements CLABSICentral Line-Associated Bloodstream InfectionData required to determine if CLABSI present:Date of positive blood culture(s)Date patient admitted to unitOrganism(s) isolated from bloodOrganism antimicrobial sensitivity patternNumber of sets organism(s) isolated from (within specific time period)Other cultures taken during same time frame which are positive for same organism.Presence of central line in patient with positive blood culture (Y/N)Modified option eliminates subjective data: Only count “common skin contaminants” if they are isolated from 2 or more sets obtained within 5 days (removes subjectivity/possible site-specific bias of “MD order of appropriate antimicrobial therapy”). This modified method was validated in one study (Yokoe, et al, ICHE, September 1998) but may not be entirely comparable to NHSN. A comparable methodology is presented in Trick, et al, Emerging Infectious Diseases, September 2004.Note: need to develop a mechanism for identifying BSI that might be secondary to infection at another site. For example, if blood and urine are both positive with the same organism, need to jump to the CAUTI algorithm to determine if the BSI is secondary to UTI. Denominator/Risk stratification data:# Central line days for specific unit per month (via electronic data extraction)CAUTICatheter-Associated Urinary Tract InfectionData needed to determine if CAUTI present:Date of positive urine culture(s) (HAI UTI algorithm or BA report Date patient admitted to unitOrganism isolated from urine > 100,000 cfu/mlOrganism antimicrobial sensitivity patternNumber of organisms/species isolated from urine sampleTemp >38CPresence of Foley catheter (present within 7 days of culture)Denominator/Risk stratification data:# Foley catheter days for specific unit per month (via electronic data extraction)C.diff or C. difficileClostridium difficileData needed to determine if C. difficile present:Date of positive stool culture(s)Date patient admitted to unitHospital Onset (HO), culture taken more than 48 hours after admission (not duplicate or recurrent case)Duplicate: a case where the number of days from a previous positive CDI LabID Event to the current positive CDI LabID Event is ≤14 days. Recurrent case: a case where the number of days from a previous positive CDI LabID Event to the current positive CDI LabID Event is >14 and ≤56. Meet AlgorithmContact Precautions Infection Control AlertsIndividuals notifiedCRECarbapenem-resistant EnterobacteriaceaeData needed to detect/determine if CRE present:Date of orderDate patient admitted to unitDates of collectionsHistory of infectionHistory of colonizationContact Precautions orderHAI or Community acquired caseInfection Control AlertDialysisDialysis Access and InfectionData needed to detect/determine if Dialysis infection present:Date of orderDate patient admitted to unitDates of collectionsCDC dialysis event protocolIPEC GuidelinesLegionellaSurgical Site InfectionData needed to detect/determine if Legionella present:Date of orderDate of positive cultureMRSAMethicillin-resistant Staphylococcus AureusData needed to determine if MRSA present:Date patient admitted to unitDates specimen collectedSpecimen typesDate of positive MRSA culture (not nares)HAI -CDC/NHSN protocolsDate of order for Contact PrecautionsInfection Control AlertsSSISurgical Site InfectionData needed to detect/determine if SSI present:Date of surgeryType of surgery (CPT code)Total Hip Arthroplasty/Total Knee Amputations (THA/TKA)Wound Classification reportClean, Clean and ContaminatedAntimicrobials started >48 hours after surgery (trigger to begin review for possible infection—indicator for likely infection)Surgical site (drainage, tissue, abscess, organ/space) culture positive within 30 days after surgery (or 1 year if implant in place)Organism isolatedOrganism antimicrobial sensitivity patternPresence of purulent drainage from surgical site (text extraction from progress note)Denominator/Risk stratification data: (from OR database)Total # of specific surgeries of same type (same NHSN code) performed during one month.9) For each surgery: Type of surgery Discharge dateDate of birthSexDuration of surgery (hours/minutes)ASA class (1-5)Wound class (C CC CO D)Endoscope used?Note: collection of only the denominator data which is readily obtained via electronic extraction, in order to determine risk stratification.VAPVentilator-Associated Pneumonia(PNEU 1, PNEU 2, PNEU 3)Data needed to determine if VAP present:Date patient admitted to unitDate of first CXR with presence of “consolidation”, “cavitation”, “infiltrate”, etc. (utilizing text extraction/natural language processing).Presence of at least 2 or more sequential CXR with similar findings as 1st one anism isolated from sputum, bronchial washing or other respiratory specimenOrganism antimicrobial sensitivity patternAccess PICIS Remote ApplicationAccess Critical care manager/CareSuiteTemp > 38WBC < 4,000 or > 12,000Purulent sputum (> 25 neutrophils and < 10 squamous epithelial cells per low power field on Gram stain) on more than one occasionAutopsy (pathology) report positive for pneumonia (text extraction)Positive blood culturePositive pleural fluid culturePaO2/FIO2 < 240Oxygen desaturation (pulse oximetry <94%)Quantitative marker for “immunocompromised” (for PNEU 3) (see NHSN Surveillance Definitions)Denominator/Risk stratification data:# Ventilator days for specific unit per month (via electronic data extraction)Influenza Surveillance:Data needed to determine if Influenza present:Date patient admitted to unitConfirmed influenza case finding:Date of positive influenza culture or rapid testResult (influenza A or B)Location of patient when culture/test obtainedPatient demographic data (zip code, facility, visit type)Admission/visit dateSyndromic surveillance/possible influenza case finding:Specific ICD9 codes (e.g., 487)Vital signs data (temp > 38) combined with triage note/telephone care note chief complaint; cough, SOB, etc. (ILI)Physician order for influenza culture/testPhysician order for amantidine (capsule), rimantidine, oseltamivir, zanamivir)Syndromic surveillance: Seven syndromes potentially caused by Category A bioterrorist agents:Respiratory – cough, pneumonia, ILI, URIGastrointestinal – vomiting, diarrheaNeurological – meningitis, botulism-likeDermatologic – hemorrhagicDermatologic – vesicular (smallpox-like)Fever, Malaise, SepsisComa/Sudden deathCoded ICD-9-CM dataTriage note/telephone care note text extraction for chief complaint consistent with any of the seven syndromesLaboratory orders and results (positive cultures, serology, etc.)Vital signsEvent datesPatient demographic data (zip code, facility, visit type)Outpatient pharmacy ordersRadiology orders and results interpretation --MDRO (MRSA, VRE, resistant Gram-negative rods such as MDR-Acinetobacter baumannii, etc.)Date/source of positive culture for specific MDRO (list TBD)Organism identifiedResistance pattern of organismLocation of patient when culture obtainedAdmission datePrevious positive cultures within xx months/yearsPatient demographics: Date of birth, age, sex, facility, date of admission, date of dischargeOrganisms of epidemiologic significance:Clostridium difficileGroup A streptococcusLegionellaM. tuberculosisAny organisms with unusual spatial/temporal clusteringDate/source of positive culture or organism-specific testOrganism identifiedResistance pattern of organism, if applicableLocation of patient when culture obtainedAdmission dateProcedures within 48 hours (CPT code)Procedure datePatient demographics: Date of birth, age, sex, facility, date of admission, date of dischargeM. tuberculosisData needed to determine if present:Coded ICD-CM dataTriage note/telephone care note text extraction for chief complaint consistent with any of the symptomsLaboratory orders and results (positive cultures, serology, etc.)Vital signsEvent datesPatient demographic data (zip code, facility, visit type)Outpatient pharmacy ordersRadiology orders and results interpretationNon-ICU BSIDate of positive blood cultureNumber of sets positiveOrganisms identifiedResistance pattern of organismLocation of patient when culture obtainedAdmission dateProcedures within 48-72 hours (CPT codes: dialysis, surgery, endoscopy, etc.)Procedure datePatient demographics: Date of birth, age, sex, facility, date of admission, date of dischargeNotifiable infectious diseases/conditionsListing of notifiable diseases for each facility, based upon local public health department requirements (modifiable by local facility)Date of positive testPatient demographics needed for health department reportingTable 2 – Required Data Elements for Antimicrobial Stewardship Program and PharmacyTool/SurveillanceData Elements/Decision Support Mechanisms NeededAntimicrobial usage and resistance trendsOrganism resistance patterns by location, culture sourceAntimicrobial usage in grams for specified drugs, by locationAntimicrobial cost dataDrug/bug mismatch alerting (BSI)Organisms isolated from blood cultureResistance pattern of organisms isolatedPhysician order of antimicrobial around time of positive blood cultureLocal alerts when drug/bug mismatch identifiedAlternative drug recommendation alertAlternative antimicrobial recommendations for targeted drugs, IV to PO alerting, etc.Physician orders for targeted antimicrobialsAlternative drug/route recommendation alerts Required Demographic Data for all NHSN InfectionsDate of birthSexFacilityLocation CodeDate of Admission to FacilityDischarge DateDied (y/n)Date of DeathTable 3 – Required Data Elements for Hand Hygiene, Secret Shopper, and Contact Precautions SurveillanceTool/SurveillanceData Elements/Decision Support Mechanisms NeededHand HygieneDate/Month/Quarter/Year of observationUnit observedJob TitlesGoal: 85% compliance Compliance: Yes or No inputNumber of observations (Capitola minimum of 16)Comment or note sectionRolling 12- month report presentation, spreadsheet format and graphs for facility overall compliance, individual units, sections (Acute care, Ambulatory Care/Outpatient, Community Living Center (CLC), Mental Health, Western Blind Rehabilitation Center (WBRC), Central Venous Catheter (CVC) BundleAbility to designate at least 2 champions per areaFuture ability to integrate with electronic hand hygiene monitoring systemHand Hygiene- Secret ShopperDate/Month/Quarter/Year of observationUnit observedJob TitlesGoal: 85% complianceCompliance: Yes or No inputNumber of observations Comment or note sectionRolling 12- month report presentation, spreadsheet format and graphs for facility overall compliance, individual units, sections (Acute care, Ambulatory Care/Outpatient, Community Living Center (CLC), Mental Health, Western Blind Rehabilitation Center (WBRC), Central Venous Catheter (CVC) BundleAbility to designate 2 champions per areaFuture ability to integrate with electronic hand hygiene monitoring systemContact Precautions- Secret ShopperDate/Month/Quarter/Year of observationUnit observedJob TitlesGoal: 90% complianceNumber of observations Rolling 12-month report presentation spreadsheet format and graphs for facility overall compliance, individual units and sections (Acute care/Inpatient care units)Ability to designate champions/secret shoppersUser CharacteristicsThe primary users of this application are the IP&Cs, Hospital Epidemiologists, Infectious Disease providers, hand hygiene champions, individuals participating in the secret shopper program for hand hygiene and contact precautions surveillance, and hospital management/leadership who will require reports based on information collected from this application. Permissions and roles will be defined for each individual. Role-Based AccessThe system will support three types of role-based access (permission) to the application: Administrator, Regular user and ExecFeature Set/RolesAdministratorRegular UserExecutiveNotesWRITE OPERATIONSCreate/update variables/parameters XCreate/update variable/parameters listsXUpdate organism antibiogramsXAssign users to facilitiesXCreate variable lists when specifying report criteriaXSave integration designation from microbiology line listingXXSave/update/delete microbiology reportXXSave/update/delete microbiology report monitorXXSave/update/delete recent results reportXXSave/update/delete pharmacy reportsXXSave/update/delete pharmacy report monitorsXXSave new institutional antibiogramsXXUpdate existing institutional antibiogramsXXCreate/update action plan and milestonesXXUpdate user profileXXXUpdate user preferences for action items, alerts, microbiology reports, pharmacy reports, microbiology monitors, pharmacy monitors, recent results/reportsXXXUpdate sets of favorite microbiology reports, favorite pharmacy reports, favorite recent results reports, and favorite monitorsXXXCreate/Save/update/modify/delete HAI/CLABSI/CAUTI/MDRO/MRSA/C.Diff/VAE/BSI/CRE/Public Health reports/VAD/Legionella/ Tuberculosis/Surgical Site Infections/Disease of interest/emerging pathogens/influenza/device days/unusual pathogens reports and surveillance toolsXXCreate/Save/update/modify/delete surveillance tools/lists for isolation notes/patient location and patient trackingXXCreate/Save/update/modify/delete any documentation that will support Quality Improvement interventions and cost saving reportsXXCreate/Save/update/modify/delete IPC/Hand Hygiene/Secret Shopper/Precaution/Device Days/Patient Days reports, results, report monitors, dashboardsXXCreate/Save/update/ edit/delete education/training/attendance rosters/surveillance, ICRA, SPS/Canteen roundsXXREAD OPERATIONSCreate new microbiology reportXXXView saved microbiology reportXXXCreate new recent results reportXXXView saved recent results reportXXXView saved recent results reportXXXView microbiology report monitorsXXXQuick searchXXXCreate new pharmacy reportXXXView saved microbiology reportXXXCreate new institutional antibiogramXXXView saved institutional antibiogramXXXDashboardsXXXExecutive dashboardXXView action plans and action plans calendarXXXView saved HAI, CLABSI, CAUTI, MRSA, MDRO, VAE, C. Diff, Legionella, Influenza, Dialysis, Hand Hygiene, Secret Shopper and Precautions monthly reports XXXView saved HAI, CLABSI, CAUTI, MRSA, MDRO, VAE, C. diff, Legionella, Influenza, Dialysis, Hand Hygiene, Secret Shopper and Precautions monthly reports placed on dashboardXXXPOINTS OF CONTACTVA Program Manager:Name: Valeria RobinsonAddress: 3801 Miranda Avenue, Palo Alto, CA 94304Voice:(650) 493-5000, ext. 69146Email:Valeria.Robinson3@Contracting Officer’s Representative:Name: Valeria RobinsonAddress: 3801 Miranda Avenue, Palo Alto, CA 94304Voice:3801 Miranda Avenue, Palo Alto, CA 94304Email:Valeria.Robinson3@Contracting Officer:Name: Joshua CohenAddress: 23 Christopher Way, Eatontown, NJ 07724Voice: (732) 440-9696Email: Joshua.Cohen2@Contract Specialist:Name: Mary Beth Hall Address: 23 Christopher Way, Eatontown, NJ 07724Voice:(732) 440-9635Email:Mary.Hall3@ADDITIONAL ITEMSSPECIAL INSTRUCTIONS/REMARKSResponse Instructions: Offerors shall provide with its quote/proposal a letter from the OEM for any and all proposed products certifying that the Offeror or the Offeror’s teaming partner, if acquiring the product through a teaming partner, is authorized to sell and provide the proposed product(s) as of the date of the submission of the quote/proposal. The OEM letter shall be provided on the OEM’s letterhead and signed by an authorized representative of the OEM. Additionally, the Offeror’s quote/proposal shall explicitly self-certify that that it will not provide Gray Market Goods and/or Counterfeit Electronic Parts, and that it has the level of certification/specialization, as required by the OEM(s), to support authorized product sale and pricing for the products proposed. Failure to include the requisite OEM letter(s) and Offeror self-certification may render the Offeror’s quote Unacceptable and thus, ineligible for RMATION SECURITY CONSIDERATIONS:The Assessment and Authorization (A&A) requirements do not apply and a Security Accreditation Package is not requiredAll VA sensitive information shall be protected at all times in accordance with local security field office System Security Plans (SSP’s) and Authority to Operate (ATO)’s for all systems/LAN’s accessed while performing the tasks detailed in this Product Description.A prohibition on unauthorized disclosure: “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).A requirement for data breach notification: Upon discovery 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, the Contractor/Subcontractor shall immediately notify the COR and simultaneously, the designated ISO, and Privacy Officer for the contract. 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. See VA Handbook 6500.6, Appendix C, paragraph 6.a.A requirement to pay liquidated damages in the event of a data breach: “In the event of a data breach or privacy incident involving SPI the contractor processes or maintains under this contract, the contractor shall be liable to VA for liquidated damages for a specified amount per affected individual to cover the cost of providing credit protection services to those individuals.” However, it is the policy of VA to forgo collection of liquidated damages in the event the Contractor provides payment of actual damages in an amount determined to be adequate by the agency. Based on the determinations of the independent risk analysis, the Contractor shall be responsible for paying to VA liquidated damages in the amount of $37.50 per affected individual to cover the cost of providing credit protection services to affected individuals consisting of the following:Notification;One year of credit monitoring services consisting of automatic daily monitoring of at least 3 relevant credit bureau reports;Data breach analysis;Fraud resolution services, including writing dispute letters, initiating fraud alerts and credit freezes, to assist affected individuals to bring matters to resolution;One year of identity theft insurance with $20,000.00 coverage at $0 deductible; and Necessary legal expenses the subjects may incur to repair falsified or damaged credit records, histories, or financial affairsA requirement for annual security/privacy awareness training: “Before being granted access to VA information or information systems, all Contractor employees and Subcontractor employees requiring such access shall complete on an annual basis either: (i) the VA security/privacy awareness training (contains VA security/privacy requirements) within 1 week of the initiation of the contract, or (ii) security awareness training provided or arranged by the contractor that conforms to VA’s security/privacy requirements as delineated in the hard copy of the VA security awareness training provided to the Contractor. If the Contractor provides their own training that conforms to VA’s requirements, they will provide the COR or CO, a yearly report (due annually on the date of the contract initiation) stating that all applicable employees involved in VA’s contract have received their annual security/privacy training that meets VA’s requirements and the total number of employees trained. See VA Handbook 6500.6, Appendix C, paragraph 9.A requirement to sign VA’s Rules of Behavior: “Before being granted access to VA information or information systems, all Contractor employees and Subcontractor employees requiring such access shall sign on annual basis an acknowledgement that they have read, understand, and agree to abide by VA’s Contractor Rules of Behavior which is attached to this contract.” See VA Handbook 6500.6, Appendix C, paragraph 9, and Appendix D. Note: If a medical device vendor anticipates that the services under the contract will be performed by 10 or more individuals, the Contractor Rules of Behavior may be signed by the vendor’s designated representative. The contract must reflect by signing the Rules of Behavior on behalf of the vendor that the designated representative agrees to ensure that all such individuals review and understand the Contractor Rules of Behavior when accessing VA’s information and information systems. ................
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