Inactive

Statement of Work Compounding Sterile Products USP 797/800 Documentation Software Jesse Brown VA Medical Center Pharmacy Services (JBVAMC) PURPOSE The purpose is to provide access to a web-based softw... Statement of Work Compounding Sterile Products USP 797/800 Documentation Software Jesse Brown VA Medical Center Pharmacy Services (JBVAMC) PURPOSE The purpose is to provide access to a web-based software program for sterile compounding within JBVAMC Pharmacy Services. Users encompass those who perform duties and tasks related to compounding, and USP Chapter 797 and 800 quality assurance monitoring within JBVAMC. SCOPE OF WORK The contractor shall provide access to a customizable web-based software program that will offer JBVAMC Pharmacy Services all they need to perform and document CSP primary and secondary engineering controls certifications, personnel competency training, risk management, and quality assurance (QA) practices necessary for a USP 797/800 compliant, safe, and efficient sterile compounding environment. All products must meet all salient characteristics, training, and system requirements, as defined in this section. SALIENT CHARACTERISTICS/REQUIRED FEATURES Access by all JBVAMC users, including pharmacists, pharmacy technicians, designated housekeeping and other staff involved in maintaining CSP program. Ability for facility staff to access their documentation and run facility level monitoring and trend reports Pre-built USP 797 and 800 required tasks, including, but not limited to, environmental documentation, sampling, and cleaning Alert notifications for overdue tasks or out-of-range results/readings and ability to document corrective actions for these findings. Ability to transmit alerts via email to individual users and/or specified groups. Pre-built observational competency assessments (i.e. donning, doffing, aseptic technique, etc.) and USP 797 and 800 Pharmacy competency exams, with the ability to custom build and add additional assessments and exams. Pre-built CSP Standard Operating Procedures and Policy templates customizable by the client System provides online, comprehensive, multimedia compounding training resources and assessment resources and offers continuing education credits for staff who complete the training. Includes pre-built hazardous drug risk assessments, customizable by the customer Ability to create form to document ward inspection, including CSP medication storage areas within the pharmacy as required by VHA Directive 1108.06. Canned and customizable reporting capabilities for all aspects of the compounding program Ability to attach files to documentation forms in the system, allowing for review by other system users, and a document repository to upload and organize training materials, SOPs, primary and secondary engineering controls certification reports, environmental and surface sampling results, gloved fingertip testing and media fill testing results, and various other materials for user access System is regularly maintained and up to date with all USP standards; provides continual support in all pre-built tasks, risk assessments, training, etc. even when revisions to USP standards are published Vendor must demonstrate successful system implementation with a similar size health system and provide three references of existing customers. TRAINING The contractor shall provide full-service setup and ongoing support, including guidance on how to properly setup the accounts for JBVAMC Pharmacy Services. This guidance will include either group or one-on-one web sessions so the end-user knows how to properly access, document, build, and customize features within the software program. An online tutorial will also be embedded in the software for ease of access by the user. The contractor will be responsible for coordinating training with pharmacy and other designated staff involved in maintaining CSP program and management in order to ensure a successful implementation by including extensive product training and ongoing support. The contractor will provide training and support for Pharmacy staff on risk management and quality assurance practices necessary to establish and maintain a safe and efficient IV compounding environment. SYSTEM REQUIREMENTS The program shall allow pharmacy staff to keep real-time QA data on environmental testing programs revolving around USP Chapter 797/800 rules and regulations related to clean room maintenance. The program shall provide reporting capability to identify and mitigate ongoing risks that may occur within our customized QA programs and respond quickly to day-to-day deviations from our programs with real-time alerts on facility and system-level compliance risks. The program shall provide easy access to reports on compliance trends and issues for hassle-free inspections by auditing agencies, in addition to a unit inspection product for managing JCAHO required ward inspections as required for all pharmacy medication storage areas per VHA Directive 1108.06 Inpatient Pharmacy Services . Reports on environmental testing compliance shall be readily retrievable for management oversight purposes. All reporting will need to include timely data that includes trending and analysis reporting by person, site, location, activity, and compounding area. The program must be an online application that does not require any hardware investment or IT resources to maintain software functionality. Implementation of the software application must be straightforward and user friendly. The program shall require passwords to be at least eight characters long and include alphabetic letters, numeric characters, and at least one punctuation mark or symbol. Any installation services will be scheduled with a contact person as assigned by the Contracting Officer s Representative (COR), Point of Contact (POC), or designee for performance on site. Contractor will assign an account representative to receive trouble reports and coordinate timely resolution, same day if possible. SPECIFIC MANDATORY TASKS AND ASSOCIATED DELIVERABLES USP 797/800 documentation software access for JBVAMC Software training and manuals PERIOD OF PERFORMANCE 12 months from subscription start date GENERAL REQUIREMENTS The contractor shall furnish all necessary materials, supplies, equipment, personnel, and supervision to provide site license services via web-based software applications. Contract Type: firm-fixed-price SECURITY REQUIREMENTS GENERAL Contractors, contractor personnel, subcontractors, and subcontractor personnel shall be subject the same federal laws, regulations, standards, and VA directives and handbooks as VA and VA personnel, regarding information and information system security The COTR and the Contractor will assure that: No other information except what is in this contract will be shared with the contractor in any follow-up communication None of the information in this contract includes entry or documentation of Protected Health Information (PHI) or Individually Identifiable Information (III) into the USP 797/800 documentation system. Contract performance does not require access to VA systems. NOTE Based on market research information obtained, there are vendors that can individually provide one or more components of the statement of work/statement of need. Bundling means consolidating two or more requirements for supplies or services previously provided or performed under separate smaller contracts, into a solicitation for a single contract that is likely to be unsuitable for award to a small business concern. Provide supporting documentation, if your market research indicates that a bundled contract is in the best interest of the Government and the contract is not likely to be awarded to a small business concern. Acquisition strategies that include bundling require extensive approvals and should be coordinated with the Contracting Officer as soon as possible: We believe that there likely are vendors that can provide all-inclusive services and bundling will not be required. PLEASE RESPONSE TO THIS SOURCES SOUGHT NOTICE IF YOU CAN PROVIDE ALL-INCLUSIVE SERVICES IN ACCORDANCE WITH THE STATEMENT OF WORK.

Inactive

Statement of Work Compounding Sterile Products USP 797/800 Documentation Software Jesse Brown VA Medical Center Pharmacy Services (JBVAMC) PURPOSE The purpose is to provide access to a web-based softw... Statement of Work Compounding Sterile Products USP 797/800 Documentation Software Jesse Brown VA Medical Center Pharmacy Services (JBVAMC) PURPOSE The purpose is to provide access to a web-based software program for sterile compounding within JBVAMC Pharmacy Services. Users encompass those who perform duties and tasks related to compounding, and USP Chapter 797 and 800 quality assurance monitoring within JBVAMC. SCOPE OF WORK The contractor shall provide access to a customizable web-based software program that will offer JBVAMC Pharmacy Services all they need to perform and document CSP primary and secondary engineering controls certifications, personnel competency training, risk management, and quality assurance (QA) practices necessary for a USP 797/800 compliant, safe, and efficient sterile compounding environment. All products must meet all salient characteristics, training, and system requirements, as defined in this section. SALIENT CHARACTERISTICS/REQUIRED FEATURES Access by all JBVAMC users, including pharmacists, pharmacy technicians, designated housekeeping and other staff involved in maintaining CSP program. Ability for facility staff to access their documentation and run facility level monitoring and trend reports Pre-built USP 797 and 800 required tasks, including, but not limited to, environmental documentation, sampling, and cleaning Alert notifications for overdue tasks or out-of-range results/readings and ability to document corrective actions for these findings. Ability to transmit alerts via email to individual users and/or specified groups. Pre-built observational competency assessments (i.e. donning, doffing, aseptic technique, etc.) and USP 797 and 800 Pharmacy competency exams, with the ability to custom build and add additional assessments and exams. Pre-built CSP Standard Operating Procedures and Policy templates customizable by the client System provides online, comprehensive, multimedia compounding training resources and assessment resources and offers continuing education credits for staff who complete the training. Includes pre-built hazardous drug risk assessments, customizable by the customer Ability to create form to document ward inspection, including CSP medication storage areas within the pharmacy as required by VHA Directive 1108.06. Canned and customizable reporting capabilities for all aspects of the compounding program Ability to attach files to documentation forms in the system, allowing for review by other system users, and a document repository to upload and organize training materials, SOPs, primary and secondary engineering controls certification reports, environmental and surface sampling results, gloved fingertip testing and media fill testing results, and various other materials for user access System is regularly maintained and up to date with all USP standards; provides continual support in all pre-built tasks, risk assessments, training, etc. even when revisions to USP standards are published Vendor must demonstrate successful system implementation with a similar size health system and provide three references of existing customers. TRAINING The contractor shall provide full-service setup and ongoing support, including guidance on how to properly setup the accounts for JBVAMC Pharmacy Services. This guidance will include either group or one-on-one web sessions so the end-user knows how to properly access, document, build, and customize features within the software program. An online tutorial will also be embedded in the software for ease of access by the user. The contractor will be responsible for coordinating training with pharmacy and other designated staff involved in maintaining CSP program and management in order to ensure a successful implementation by including extensive product training and ongoing support. The contractor will provide training and support for Pharmacy staff on risk management and quality assurance practices necessary to establish and maintain a safe and efficient IV compounding environment. SYSTEM REQUIREMENTS The program shall allow pharmacy staff to keep real-time QA data on environmental testing programs revolving around USP Chapter 797/800 rules and regulations related to clean room maintenance. The program shall provide reporting capability to identify and mitigate ongoing risks that may occur within our customized QA programs and respond quickly to day-to-day deviations from our programs with real-time alerts on facility and system-level compliance risks. The program shall provide easy access to reports on compliance trends and issues for hassle-free inspections by auditing agencies, in addition to a unit inspection product for managing JCAHO required ward inspections as required for all pharmacy medication storage areas per VHA Directive 1108.06 Inpatient Pharmacy Services . Reports on environmental testing compliance shall be readily retrievable for management oversight purposes. All reporting will need to include timely data that includes trending and analysis reporting by person, site, location, activity, and compounding area. The program must be an online application that does not require any hardware investment or IT resources to maintain software functionality. Implementation of the software application must be straightforward and user friendly. The program shall require passwords to be at least eight characters long and include alphabetic letters, numeric characters, and at least one punctuation mark or symbol. Any installation services will be scheduled with a contact person as assigned by the Contracting Officer s Representative (COR), Point of Contact (POC), or designee for performance on site. Contractor will assign an account representative to receive trouble reports and coordinate timely resolution, same day if possible. SPECIFIC MANDATORY TASKS AND ASSOCIATED DELIVERABLES USP 797/800 documentation software access for JBVAMC Software training and manuals PERIOD OF PERFORMANCE 12 months from subscription start date GENERAL REQUIREMENTS The contractor shall furnish all necessary materials, supplies, equipment, personnel, and supervision to provide site license services via web-based software applications. Contract Type: firm-fixed-price SECURITY REQUIREMENTS GENERAL Contractors, contractor personnel, subcontractors, and subcontractor personnel shall be subject the same federal laws, regulations, standards, and VA directives and handbooks as VA and VA personnel, regarding information and information system security The COTR and the Contractor will assure that: No other information except what is in this contract will be shared with the contractor in any follow-up communication None of the information in this contract includes entry or documentation of Protected Health Information (PHI) or Individually Identifiable Information (III) into the USP 797/800 documentation system. Contract performance does not require access to VA systems. NOTE Based on market research information obtained, there are vendors that can individually provide one or more components of the statement of work/statement of need. Bundling means consolidating two or more requirements for supplies or services previously provided or performed under separate smaller contracts, into a solicitation for a single contract that is likely to be unsuitable for award to a small business concern. Provide supporting documentation, if your market research indicates that a bundled contract is in the best interest of the Government and the contract is not likely to be awarded to a small business concern. Acquisition strategies that include bundling require extensive approvals and should be coordinated with the Contracting Officer as soon as possible: We believe that there likely are vendors that can provide all-inclusive services and bundling will not be required. PLEASE RESPONSE TO THIS SOURCES SOUGHT NOTICE IF YOU CAN PROVIDE ALL-INCLUSIVE SERVICES IN ACCORDANCE WITH THE STATEMENT OF WORK.