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FBO DAILY - FEDBIZOPPS ISSUE OF AUGUST 04, 2017 FBO #5733
DOCUMENT

99 -- Quality Management Software - Laboratory - Attachment

Notice Date

8/2/2017
 

Notice Type

Attachment
 

NAICS

511210 — Software Publishers
 

Contracting Office

Department of Veterans Affairs;Network Contracting Office (NCO) 15;3450 S 4th Street Trafficway;Leavenworth KS 66048
 

ZIP Code

66048
 

Solicitation Number

VA25517N0866
 

Response Due

8/7/2017
 

Archive Date

10/6/2017
 

Point of Contact

Emilio Ballentos
 

E-Mail Address

.ballentos@va.gov<br
 

Small Business Set-Aside

N/A
 

Description

This is a SOURCES SOUGHT announcement only. It is neither a solicitation announcement nor a request for proposal or quote and does not obligate the Government to award a contract. Responses to this Sources Sought must be in writing. The purpose of this Sources Sought Announcement is for market research, to make appropriate acquisition decisions, and to gain knowledge of potential qualified businesses capable of providing the following: QM Software for Path & Lab Description of Use: The VA St. Louis Health Care System (John Cochran and Jefferson Barracks Divisions) is in need of Quality Management software which is critical and necessary for maintaining compliance with current CAP, AABB, FDA, and A2LA guidelines and industry standards as well as patient safety and quality initiatives. The Quality Management software should encompass the entire laboratory function to ensure quality, accuracy, and timeliness of patient care and drive process improvement initiatives. This document highlights the technical specifications and services being requested by the facility for consideration towards purchase of this software. Generic requirements and functionality for the equipment requested: General Design Simple, menu-driven, customizable portal or user interface. Modular software that components may be added or removed without requiring major upgrades or changing the functionality of the system. Multiple role or group based permission levels that enable different levels of user access. The system should enable easy addition and removal of user and level of access. Total traceability tracks who performed what steps of task or approval. Ability to create customizable reports. Set priority tasks and reminders. Assign to self or other users. Seamless module integration that allows linking of documents, forms, events, training, tasks, CAPA, audits, etc. and minimizes the number of approval steps in the process. (Approval of a CAPA that revised a document and updated an audit form would launch the document approval workflow and training process.) Customizable workflows based on department or level of importance. Ability to generate, track, distribute and utilize wikis, links to other sites or content therein (cap.org, CLSI), web parts, discussion boards, shift hand-off communication tools, lists, surveys, competencies, calendars or shared videos. Generates site usage reports allowing some determination of system effectiveness. Document Control The ability to manage the entire document lifecycle from creation, approval, editing, in use status and retirement. Facilitate the use of standardized reporting for all sections of the lab. Identify documents using a numeric or alphanumeric system and be traceable to associated forms, job aids, derivative documents or policies, etc. Offer customizable design elements for the system or document control log, which may include but not be limited to, document number, name, implementation date, location of copies, last revision date/approval/version number, review date/approval, review due date, and date retired. It must capture the changes made between versions and have a link between the version and approval. Document control log is updated automatically as documents, versions, and approvals are updated. Standard file extension compatibility with backward compatibility (.xls,.xlsx,.pdf,.mht,.htm,.html,.doc,.docx). Multiple options for document list, query, and categorize including keywords, departments, or review status. It must be secure from editing for both the draft and final except for those assigned. The document control system must ensure that only current policies procedures or forms are in use. The ability to show the 'status' of documents - ie 'draft', in approval routing, final, implemented, in review, retired. Automatic routing of new/revised documents to appropriate persons for review at appropriately determined intervals for draft review, approval, and periodic review. Ability of frequent reviewers to retrieve documents from a list of "in review' rather than having to open each email. Accessibility and communication to outside services (non-PLMS) for notification of document availability and accessibility to read document (full network/user accessibility). Examples include the ability to share manuals with distant CBOCs and to inform wards and clinics using point of care instruments about new policies, procedures, form and job aids, etc. Has the ability to audit/query records for timeliness/completion. Maintains document history for length of time required by regulations. Flexible version control to allow for major and minor changes, to enable versioning by dates or numbers and that can be enabled and disabled. Versioning should contain limits, history, restoration, archiving, and deletion. Enables the creation of specific metadata fields for each library. Current and default views of document libraries are customizable. Flexibility of workflows to accommodate fast track needs, vacations or extra approvals. Audit or Accreditation Management Import of accreditation standards from common accreditation agencies (e.g. - CAP, AABB, A2LA, and FDA). Flexible workflow to delegate audits to multiple people with different levels of review. Ability to view or print report on current compliance. Ability to set and assign tasks to personnel, begin CAPA workflow associated with non-compliant standards, or link to document control for revisions. Comparison of previous year to current year standards. Option to transfer or update standards from previous year to current year. Creates links from standard to all appropriate supporting documentation. Reminders sent about upcoming audits and reviews that must be performed before due date. CAPA All users have the ability to enter nonconforming events. Nonconforming event forms may be completed offline and uploaded to the system. Access to edit or review corrective actions and preventive actions based on user role or permissions. Automatically routes nonconformities through CAPA workflow. Ability to customize forms, workflow, and responsibility for documentation and resolution of nonconformities. Searchable relational database of nonconforming events that allows users to build queries, detect trends, and analyze data. Simple to customize and pull reports, statistics, and charts to monitor performance. Personnel Competency / Training Ability to create training documents, links, and videos and assign to staff based on roles. Competency forms created and linked through document control. Ability to schedule competency and performance evaluations with reminders and due dates. Send alerts to employee and supervisor when competency or training is approaching due date or unacceptable. Staff access to their own competency and training files for their review. System Support: Provide initial and ongoing training sufficient for all of the system users at different levels. Customer Service Support 24/7 phone support. Admin support M-F business hours at minimum 2 requests per month. Server Access Minimal maintenance. System access must be password protected and PIV compliant according to VA Standards. Vendor to provide all necessary server hardware to host system. Storage capacity to archives all document types and workflow histories for at least 5 years after removal from use to meet the more stringent transfusion medicine and quality documents requirements is preferred. Alternatively, a minimal storage capacity is needed for archiving transfusion service documents and review/approval histories for 5 years, and other laboratory section records for 2 years. Required Interfaces: This software may be either located on our local server or web-based. It will not be directly interfaced with any other programs. However, if is located outside of our local server it must meet appropriate security requirements to protect potentially sensitive health information. Any vendor selected must undergo One-VA TRM approval. It is also expected that the selected vendor would assist in creating and agree to an MOU-ISA. Optional/Value Added Features: Note additional value added features that would be a benefit for the equipment to have. Asset / Inventory Management Ability to create electronic QC logs Cost of Poor Quality function / report Document Control The ability of multiple users to access and edit documents. Multiple-user edits can be subsequently merged/reviewed for merge. Personnel Competency / Training Ability to monitor and track continuing education credits. Option to create and assign peer performance reviews for co-workers. Creation of on-line exams, grading, and file test results. Pertinent Regulations, Standards and Guidelines: In obtaining a quality management system, the following regulations, standards and guidelines should be met or exceeded. CAP Requirements: GEN.13806 - The laboratory has a written quality management (QM) program. GEN.16902 - For laboratories that have been CAP accredited for more than 12 months, the QM plan is implemented as designed and is reviewed annually for effectiveness. Evidence that the plan has been implemented as designed requires all of the following: quality measurements/assessments specified in the plan are being substantially carried out; there is evidence of active review of quality measurements; if target performance levels are specified in the plan and the targets are not being met, there are records of follow-up action; any interventions/changes to operations that are specified in the plan have been carried out as scheduled, or the reason for delay recorded; AND any communication of information that is required by the plan have taken place GEN.20208 The QM program includes a process to identify and evaluate errors, incidents and other problems that may interfere with patient care services. GEN.20316 - The QM program includes monitoring key indicators of quality in the pre-analytic, analytic, and post-analytic phases. GEN.20325 - The laboratory has a procedure for employees and patients to communicate concerns about quality and safety to management. GEN.55450 - There are records that all staff have satisfactorily completed initial training on all instruments/methods applicable to their designated job. GEN.55500 - The competency of each person performing patient testing to perform his/her assigned duties is assessed. GEN.20375 The laboratory has a document control system to manage policies, procedures and forms for all process and activities subject to CAP accreditation. The system is recommended to maintain a control log listing all current policies, procedures, and forms with the locations of copies (including derivative documents, card files and summary charts). COM.10000-A complete procedure manual is available at the workbench or in the work area. This is a derivative document and is subject to the above control requirement. If card files are used, these cards are subject to document control. COM.10100 There is documentation of review of all technical policies and procedure by the current laboratory director or designee at least every two years. COM.10200 The laboratory director review and approves all new technical policies and procedures, as well as substantial changes to existing documents, before implementation. TLC.11485 Following a change in laboratory directorship, the new laboratory director approves the laboratory polies and procedures over a reasonable period of time. This approval must be documented. The approval should be completed within 3 months. COM.10300 The laboratory has a system documenting that all personnel are knowledgeable about the contents of procedure manuals (including changes) relevant to the scope of their testing activities. COM.10500 When a procedure is discontinued, a paper or electronic copy is maintained for at least 2 years, recording initial date of use, and retirement date. Responses to this notice shall include: Company Name Address Point of Contact Phone, Fax, and Email DUNS number Vendor must be an AUTHORIZED DISTRIBUTOR of the product. Actual quote is not required. Please respond no later than 8/07/2016 at 11:00 EST. to emilio.ballentos@va.gov with SOURCES SOUGHT VA255-17-N-0866 in the subject line.
 

Web Link

FBO.gov Permalink
(https://www.fbo.gov/spg/VA/LeVAMC/VAMCKS/VA25517N0866/listing.html)
 

Document(s)

Attachment
 

File Name: VA255-17-N-0866 VA255-17-N-0866.docx (https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=3707214&FileName=VA255-17-N-0866-000.docx)

Link: https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=3707214&FileName=VA255-17-N-0866-000.docx

 

Note: If links are broken, refer to Point of Contact above or contact the FBO Help Desk at 877-472-3779.
 

Place of Performance

Address: Department of Veterans Affairs;St. Louis VA Medical Center;915-North Grand Blvd.;St. Louis, MO.

Zip Code: 63106-1621
 

Record

SN04608489-W 20170804/170802231732-b77b5277fbe7c2111e71adb80306a426 (fbodaily.com)
 

Source

FedBizOpps Link to This Notice
(may not be valid after Archive Date)

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