Animal Protocol, Animal Facility Operations and Veterinary Medical Records Management Software for the NIH Animal Health Care Section
Added: Jun 06, 2018 2:36 pm Title: Animal Protocol, Animal Facility Operations and Veterinary Medical Records Management Software for the NIH Animal Health Care Section This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in Subpart 12.6 as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; proposals are being requested and a written solicitation will not be issued. The solicitation number is NIH-NIDA-CSS-18-4895770 and the solicitation is issued as a request for quotation (RFQ). This acquisition is for a commercial item or service and is conducted under the authority of the Federal Acquisition Regulation (FAR) Part 13—Simplified Acquisition Procedures; FAR Subpart 13.5—Simplified Procedures for Certain Commercial Items; and FAR Part 12—Acquisition of Commercial Items, and is expected to exceed the simplified acquisition teshold. The associated NAICS code is 541511, “Custom Computer Programming Services” and the small business size standard is $27,500,000 or less in average annual receipts. This acquisition is pursued as a Total Small Business Set-Aside and is set-aside exclusively for small business concerns in accordance with the NAICS code and associated small business size standard indicated above. For purposes of a Total Small Business Set-Aside, a small business concern, in addition to meeting the small business size standard for the applicable NAICS code, is defined as “any business entity organized for profit with a place of business located in the United States or its outlying areas and that makes a significant contribution to the U.S. economy tough payment of taxes and/or use of American products, material and/or labor, etc.” Contract Type A firm-fixed price type contract for commercial items is anticipated for this acquisition with a Base Requirement inclusive of the final delivery the software package and related implementation support activity inclusive of data migration from extant systems, configuration of the software to function optimally in the ACF facilities, testing of the software and training of NIH staff on use of the software package. Contract Options:The anticipated contract will also contain four successive 12-month Term Options for continued maintenance support. These Term Options for continued maintenance support will also be firm-fixed price. Statement of Need and Purpose: The Animal Health Care Section (AHCS), National Institutes of Health requires replacement software for two separate systems currently in use, one for managing Animal Study Proposals (ASPs), and one for managing animal facility operations. The AHCS needs to acquire and implement a commercial, off-the-shelf (COTS) software system to be used by NINDS and NIDCR to facilitate the tracking and maintenance of animal protocols, animal inventory, breeding, facility operations and health status of research animals. In brief, the system shall:§ Track and maintain specific regulatory requirements (IACUC Tracking).§ Have automated, multi-species animal inventory management and census reporting for animals and cages and for billing and cost accounting.§ Have ability to track and maintain data for animals being imported and quarantine testing (Receiving and Quarantine) and animals being exported.§ Have functionality for animal health monitoring and veterinary assessments.§ Provide online access and reporting to intramural investigators and other stakeholders.§ Comply with Federal, HHS, and NIH Information Security regulations and policies. The Contractor shall facilitate the implementation and integration of a COTS software system, insuring preservation of data in existing software systems currently in use, minimizing downtime and impact to users. Background Information and Objective: Glossary: ACUC- Animal Care and Use CommitteeASP – Animal Study ProposalNCCIH – National Center for Complementary and Integrtive HealthNHLBI – National Heart, Lung and Blood InstituteNIDCD – National Institute on Deafness and Other Communication DisordersNIDCR – National Institute of Dental and Craniofacial ResearchNINDS – National Institute of Neurological Disorders and Stroke The ACUC that that supports investigators of NINDS, NIDCD and NCCIH reviews ASPs uses an ASP management software system that has existed since approximately 2005. It was developed and supported by NHLBI. NHLBI will no longer provide support for this system after December 2018. The computer code underlying this web-based system is antiquated and requires a replacement system. The ACUC supporting investigators of the NIDCR uses a different system developed within NIH that is also due to be retired. The AHCS operates two animal facilities, a small one in Bldg. 10/ACRF and a much larger one in Bldg. 35. Some facility management tasks, such as cage card creation and census tracking, utilize a software program developed in-house by a part-time independent contractor. Despite years of development efforts, the program provides mixed results, at best. The NIDCR animal program operates an animal facility in Bldg. 30. Both animal programs also house animals in other facilities on the NIH Bethesda campus that are operated by other entities. The ASP and animal facility operations systems exist in silos; the information contained in them is not easily shared. Our objective is to acquire a commercially available integrated software package that can replace these systems and extend their capabilities. There are multiple vendors with market-tested software packages that typically are available in several modules. A secondary objective is to acquire a module that will allow us to transition our veterinary medical records from paper to electronic format to gain additional efficiencies. Generic Name of Product: Animal Protocol, Animal Facility Operations, and Veterinary Medical Records Management Software. Salient characteristics The general features of the system are described first. Specific features of the tee functions (ASP management, facility operations and medical record management) are provided following the general attributes. The system should provide one access point for all functions, including ASP management, animal health records, technical requests and facility management functions (including census, animal number monitoring, report generation, user training documentation, etc.), all of which communicate with each other. Overall system requirements:· Web based· Compatible with Apple and Microsoft systems, at a minimum· Full integration between modules· Uses resource pools within the database· Oracle or MS SQL Server database structure· Internal server-based or Cloud-based· Choice to purchase outright or SAAS (software as a service)· Section 508 compliant. Offerors will need to submit a completed Product Accessibility Template https://www.hhs.gov/web/section-508/contracting/technology-products/product-accessiblity-template/index.html. System documentation must also be 508 compliant.· Ability to use wireless devices for data entry and system interface at the animal room/animal cage level· Ability for users to configure most/all features (user configurable)· Should have ability to customize "views" that allow user to only view data fields that they need to utilize· Capability of supporting Active Directory for user authentication. System should support at least two of the following: Native Windows Authentication, LDAP, or SAML.· Web based user dashboards· Audit trails· User based· Support for RFID and barcode input devices· Robust data querying capabilities· Robust reporting capabilities· Full data importing and exporting capabilities· Ability to integrate with existing, currently-used software (identified for each of the tee Functions in the Function descriptions below)· Design includes dropdown lists for data consistency and ease of data entry· User notifications tu email server (MS Outlook), messaging, and system dashboard· Onsite hosting (latest windows server or RedHat Linux, database of MS SQL server or Oracle) or cloud hosting that is FedRamp Certified· If onsite, ability to host on existing VMware Virtual Hosting cluster· If onsite, ability to be patched monthly with Operating system, Database, Vendor and other security updates.· Integration with NIH CA Siteminder SSO (single sign on) to allow AD username, password and also PIV card access· Offeror will setup multiple environments (test, staging, training and production) to support evaluation and implementation of the software. Will configure the COTS software to meet the functional and technical requirements of this Purchase Description.· Offeror will provide training for end-users on application use, systems administrators on administering and managing the COTS product and provide documentation and training manuals.· Additional desirable (not required) features:o GLP compliant/validate-ableo Automatically generates email reminders when signatures or tasks are overdue. Animal Protocol Management Function:Current systems in use for Animal Protocol Management are a web based system at NINDS and FileMaker at NIDCR. The COTS system for this requirement must be able to migrate approximately 3-5 years’ worth of existing data from these systems. · Allows PIs and lab members to easily create new protocols, protocol amendments and annual reviews.· Permits creation of a copy of previous version of a protocol, including all approved amendments, at the time of protocol renewal.· Allows storage and retrieval of descriptions of commonly performed procedures which can be accessed by all users (boilerplate language).· Responses to questions permit unlimited, or very generous, numbers of characters to be entered.· Ability to upload a variety of image types.· Track and alert when required training courses are completed and when refresher training is due.· Permits storage and retrieval of training and experience information of PIs/lab members within the protocol.· Supports queries concerning which personnel are identified on which protocols.· Supports two different animal protocol formats for the two different ACUCs· Allows User-customization of at least some protocol fields to limit uploading of supplemental documents.· Periodically auto-saves documents in progress, including at the times of entry into sleep mode or session time-outs.· Identifies areas of missing information in protocol drafts and submissions.· Automatically notifies ACUC support staff when documents are submitted.· Allows ACUC support staff to easily generate meeting agendas and letters to PIs after ACUC review of documents and after document approval.· Separates language entered in protocol amendments from previously approved language to allow efficient review of amendments by ACUC members and other users. Allow IACUC reviewers to electronically comment on IACUC applications· Route IACUC applications for review and approval, notifying reviewers by email· Permits document approval at multiple levels (administrative, veterinary verification and consultation, designated member review and full ACUC review).· Supports electronic signatures· Automatically generates email reminders to PIs and/or lab members at User-set intervals before annual review and protocol renewals are due.· Automatically imports data from facility operations module and deducts animals ordered or bred in-house from the number of approved animals for each animal protocol. · Allows importation of numbers of animals already used on existing protocols at the time of implementation.· Allows Principal Investigators to view animal usage data.· Permits either uploading or creation of limited-information versions of animal protocols that are approved by other IACUCs under which animals will be housed in our facilities.· Automatically generates email notices to PIs and/or lab members when User-determined levels of approved animal usage is reached.· Allows ACUC support staff to generate lists on animal procedure locations to be visited for semiannual inspections.· Permits tracking of deficiencies identified on semiannual inspections relative to ACUC-established correction dates.· Allows ACUC support staff to retrieve numbers of animals used, by species and USDA pain/distress categories during User-set intervals for reporting purposes.· Facilitates AAALAC program description by supporting queries for specific items such as hazard use, multiple survival surgery, food or fluid restriction, physical restraint, etc. Facility Operations Function:Current systems in use for Animal Protocol Management are an 8.1 GB Microsoft Access Database (cage card creation and census tracking) at NINDS (no software currently in use at NIDCR). The COTS system for this requirement must be able to migrate approximately 3-5 years’ worth of extisting data from these systems. Software must allow for importation of data from the Oracle-based NIH Central Animal Procurement System (CAPS). (The software for this requirement will NOT encompass animal ordering, only the ability to import data from the extant central NIH CAPS Oracle-based system). · Generates cage cards and/or labels to uniquely identify individual cages. Cards or labels can be generated in advance and left in holding rooms for investigator use when separating cages.· Activates/deactivates cage cards easily. · Cage cards deactivated after User-defined interval of absence during census-taking.· Tracks cage cards on expired protocols and permits easy replacement or update when protocols are renewed.· Can generate lists of cages currently assigned to particular protocols.· Supports reconciliation of database information to easily identify discordant or erroneous information.· Generates reports of expected deliveries of animals, feed, bedding, and other supplies by type, date and vendor.· Segregates orders by funding stream.· Imports data from the NIH Central Animal Procurement System (CAPS) and deducts the animals ordered from the number of approved animals available to the PIs/lab members· Imports animal numbers data from in-house breeding and deducts the animals from the number of approved animals available to the PIs/lab members· Supports census-taking of cages currently in use in each facility, by facility, by housing room, by PI and by protocol number.· Allow for the use of hand held device or similar to capture census data· Generates monthly census reports by Institute, PI, location (building and room), cages assigned and the current or average cages used for a period of time.· Generates notifications when a PI’s active cages in the facility exceed their cage allocation.· Maintain & Track room/facility capacity & occupancy levels for both animals & cages· Track census data at various levels and across multiple facilities: Lab, Investigator, Accounts, Animal Study Protocols· Tracks breeding cage data including Building, room number, protocol number, cage card number, species, strain, birth dates and dates on which weaning is due.· Supports queries of rodent weaning information by time period and by protocol.· Tracks inventories of supplies and equipment, and their locations within the facility.· Tracks equipment requiring periodic calibration or preventive maintenance and the due dates of these services.· Tracks equipment requiring periodic sanitization and its location; tracks the due dates of these services.· Accepts census data of cages present within the facility by date and species. Can accept bar codes, RFID and QR/Aztec codes.· Supports electronic versions of various husbandry forms and activity logs and allows data entry via smartphone or tablet interface.· Tracks training of animal facility staff.· Accepts uploads of visual aids used in training of facility staff and PIs/lab members.· Supports links to SOPs and other useful documents which can be read via smartphone or tablet interfaces.· Supports design and execution of an animal health surveillance program. Must have the ability to track sentinel health monitoring, both results and scheduling, by facility, room, rack, cage and animal· Allows recording animal testing data and results· Maintains and tracks facility health status data· Supports tracking of imports and exports of animals to/from other research facilities.· System must have ability to track and maintain data for animals being imported and quarantine testing:· Must allow tracking importation and health status of animals being imported to facilities· Must allow web-based processing of import and export requests· Tracks importation dates and release dates· Generates testing schedule based on type of importation· Generates multiple reports based on quarantine projects· Allows recording/uploading of health status reports from multiple Institutes at NIH· Approval, arrival and export of animals in quarantine· Must have the ability to track animal shipments, including requestor, shipping destination, courier service to be utilized, required health documents, date of request for shipment, date of shipment and shipping costs.· Must have ability to upload health records required for shipping, allow for electronic signature for approvals, and have the ability to identify animals for shipping.· Supports task management with User-generated lists which can be customized for each member of the facility and veterinary staffs. Supports task scheduling.· Tracks the allocations of cages by Building, Institute, PI, room and rack levels. Tracks the locations within the facility of cage allocations.· Tracks utilization of cage allocations and space available to PIs/lab members.· Automatically generates notifications of PIs whose cage census exceeds their cage allocations.· Permits investigators to submit technical service requests.· Additional desirable (not required) features: Supports the ability to track and bill for staff time performing technical or breeding colony support procedures. Allows technical staff to record number of hours worked procedures:o Supports breeding colony management and record keeping.o Cage cards distinguish the origin of the housed animals, for example: ordered from a vendor; weaned from in-house breeding; transferred from another facility; etc. Veterinary Medical Records Management Function:No data migration from existing systems is required for the Veterinary Medical Records Management Function. · Supports User-defined customizable templates, including drop-down menus· Supports multiple species· Supports animal graphical model for describing surgical and disease location· Permits data (observations, treatments, surgical history, etc) entry from multiple sources including computers, tablets and smartphones.· Has the ability to enter data on individual animals or groups of animals in a batch process if the same procedure(s) is performed on animals· Must have individual user ID attached to each entry into the medical record· Generates cage card images or accepts images from ancillary devices.· Accepts uploads of other informational documents.· Supports links to ASPs, SOPs and other system reports.· Supports task templates for User-defined typical treatment plans for common conditions· Can import existing medical records.· Generates email notifications to technicians and veterinarians when examinations and rechecks are due.· Generates email notifications to investigators when new animal health cases are found (including any prior treatments), or treatment plans updated. Permits entry and storage of investigator contact information and maintains distribution lists by lab and animal protocol.· Permits queries of health problem incidence/prevalence by problem type, housing room, facility and/or protocol· Permits queries of animal mortalities by housing room, facility, protocol and/or rodent strains. Implementation, Configuration and TrainingImplementation, configuration of the system and training are part of this requirement. During implementation periodic actual or digital meetings, suggested biweekly, to discuss and monitor the progress and challenges encountered in implementation and optimization of the system to our work sites. It is anticipated that 2-4 on-site visits by a vendor project officer will be needed to become familiar with our operations and assist with implementation, acceptance and transition onto the new system. An implementation test package should be offered for each function listed above; this package should allow validation of the accuracy of the software in the NINDS/NIDCR environments using test cases and scenarios relevant to the animal research environment.WarrantyA 12-month warranty is required for this software package. Quantity: One software package ecompassing all tee Functions contained in the Salient Characteristics section of this Purchase Description (Animal Protocol Management Function, Facility Operations Function and Veterinary Medical Records Function) for an estimated 320-400 users. One implementation test package to allow for validation of the accuracy of the software in the NINDS/NIDCR environments using test cases and scenarios relevant to the animal research environment for each of the tee Functions contained in the Salient Characteristics section of this Purchase Description. Training of on-site users for software package prior to final implementation. A 12-month warranty is required for this software package. Delivery Date/Timeline for Implementation: Implementation to begin upon receipt of order. It is anticipated that configuration of the software to function optimally in our worksites will take 1-2 months; with testing of the software occurring concurrently and informing the optimization. Training on-site users is expected to take approximately one month. Ideally, the date of conversion will take place no later than December 1, 2018, though an earlier date is desirable. A proposed timeline from the date of award should be included in the proposal. The provision at FAR clause 52.212-1, Instructions to Offerors – Commercial Items, applies to this acquisition. The provision at FAR clause 52.212-2, Evaluation – Commercial Items, applies to this acquisition. (a) The Government will award a contract resulting from this solicitation to the responsible offeror whose offer conforming to this solicitation will be most advantageous to the Government in accordance with the stated Evaluation Criteria (see Attachment 1: Technical Evaluation Criteria). (b) Although the technical evaluation of proposals shall be considered paramount in the award selection decision, results from our cost/price and past performance evaluations are also important to the overall contract award decision. All evaluation factors other than cost or price (i.e. technical and past performance), when combined, are significantly more important than cost/price. The Government intends to make an award to that offeror whose proposal provides the best overall value to the Government. (c) A written notice of award or acceptance of an offer, mailed or otherwise furnished to the successful offeror within the time for acceptance specified in the offer, shall result in a binding contract without further action by either party. Before the offer’s specified expiration time, the Government may accept an offer (or part of an offer), whether or not there are negotiations after its receipt, unless a written notice of withdrawal is received before award. Offerors must include a completed Price Quote Template (ATTACHMENT 2), with their response to this Combined Synopsis/Solicitation. (Offer’s may also use their own format/templates as long as all of the requested information contained in the attachment is included). Offerors are instructed to include a completed copy of the provision at FAR clause 52.212-3, Offeror Representations and Certifications—Commercial Items, with its offer, included as Attachment 3. Please note that if your SAM Reps and Certs are current and would not need to be adjusted to fit this particular requirement you will only need to complete paragraph b). Options: The Government will evaluate offers for award purposes by adding the total price for all options to the total price of the basic requirement. The Government may determine that an offer is unacceptable if the option prices are significantly unbalanced. Evaluation of options shall not obligate the Government to exercise the option(s). The FAR clause at 52.212-4, Contract Terms and Conditions – Commercial Items, applies to this acquisition. Addendum to FAR clause 52.212-4, Contract Terms and Conditions – Commercial Items, applies to this acquisition. The additional contract terms and conditions are as follows: FAR 52.217-9 OPTION TO EXTEND THE TERM OF THE CONTRACT (March 2000). a) The Government may unilaterally exercise any of the Term Options provided that the Government gives the Contractor a preliminary written notice of its intent to exercise said option at least 30 days prior to contract expiration. (Should it be the Government’s intent to NOT exercise the next subsequent Term Option, the Government will notify the contractor 60 days prior to contract expiration in order to allow for the preparation of any final contract deliverables). The preliminary notice does not commit the Government to exercise the referenced Option. b) If the Government exercises any of the Term Options, the extended contract shall be considered to include this option clause. c) The total duration of the ordering period of the contract, including the exercise of any Term Options, under this clause, shall not exceed five years. CONTRACTING OFFICER'S REPRESENTATIVE (COR)The following Contracting Officer's Representative (COR) will represent the Government for the purpose of this contract: TBD The COR is responsible for: (1) monitoring the Contractor's technical progress, including the surveillance and assessment of performance and recommending to the Contracting Officer changes in requirements; (2) interpreting the statement of work and any other technical performance requirements; (3) performing technical evaluation as required; (4) performing technical inspections and acceptances required by this contract; and (5) assisting in the resolution of technical problems encountered during performance. The Contracting Officer is the only person with authority to act as agent of the Government under this contract. Only the Contracting Officer has authority to: (1) direct or negotiate any changes in the statement of work; (2) modify or extend the period of performance; (3) change the delivery schedule; (4) authorize reimbursement to the Contractor for any costs incurred during the performance of this contract; (5) otherwise change any terms and conditions of this contract; or (6) sign written licensing agreements. The Government may unilaterally change its COR designation. POST AWARD EVALUATION OF CONTRACTOR PERFORMANCE Contractor Performance Evaluations Interim and Final evaluations of Contractor performance will be prepared on this contract in accordance with FAR Subpart 42.15. The Final performance evaluation will be prepared at the time of completion of work. In addition to the Final evaluation, Interim evaluation(s) will be prepared Annually as follows: on the anniversary date of contract award, covering the prior 12-months of performance. Interim and Final evaluations will be provided to the Contractor as soon as practicable after completion of the evaluation. The Contractor will be permitted thirty days to review the document and to submit additional information or a rebutting statement. If agreement cannot be reached between the parties, the matter will be referred to an individual one level above the Contracting Officer, whose decision will be final. Copies of the evaluations, Contractor responses, and review comments, if any, will be retained as part of the contract file, and may be used to support future award decisions. Electronic Access to Contractor Performance Evaluations Contractors may access evaluations tough a secure Web site for review and comment at the following address: http://www.cpars.gov FAR clause at 52.212-5, Contract Terms and Conditions Required to Implement Statutes or Executive Orders–Commercial Items, applies to this acquisition and is included as Attachment 4, with applicable clauses indicated in said Attachment.. Additionally, please see Attachment 5, “Applicable FISMA Clauses”, which are likely to be contained in any award resulting from this solicitation. These contract clauses relate to Information and/or Physical Access Security. The following additional contract requirement(s) or terms and conditions as determined by the contracting officer are necessary for this acquisition and consistent with customary commercial practices: Not applicable The Defense Priorities and Allocations System (DPAS) are not applicable to this requirement. Responses to this solicitation must include sufficient information to establish the interested parties’ bona-fide capabilities of providing the product or service. The price quote shall include: unit price, list price, shipping and handling costs, delivery days after contract award, delivery terms, prompt payment discount terms, F.O.B. Point (Destination or Origin), product or catalog number(s); product description; and any other information or factors that may be considered in the award decision. Such factors may include: past performance; special features required for effective program performance; trade-in considerations; probable life of the item selected as compared with that of a comparable item; warranty considerations; maintenance availability; and environmental and energy efficiency considerations. This Combined Synopsis/Solicitation does not commit the Government to pay any costs incurred in the submission of quotes/proposals. In addition, the Dun & Bradstreet Number (DUNS), the Taxpayer Identification Number (TIN), and the certification of business size must be included in the response. All offerors must have an active registration in the System for Award Management (SAM) www.sam.gov.” All quotes/offers must be received by 5 PM EST June 21, 2018 and reference number NIH-NIDA-CSS-18-4895770. Quotes/offers shall be submitted electronically to Jason Williams, Contracting Officer at willjas@nida.nih.gov Fax responses will not be accepted. For any questions or further information regarding this solicitation, please contact Jason Willliams, Contracting Officer, NINDS Contracts Management Branch, NIDA, NIH at PH: 301-496-5985; E-mail: willjas@nida.nih.gov
NIH-NIDA-CSS-18-4895770 Department of Health and Human Services National Institutes of Health
6/6/18, 2:36 PM