Requirement:
Guide the Bureau of Alcohol, Tobacco, Firearms and Explosives Scientific Laboratories through a controlled requirements elicitation process, LIMS procurement and implementation to replace three home-grown LIMS applications used by the forensic and regulatory laboratories. Additionally the ATF requested LAS, Inc. to provide the end-user training and instrument integration activities.

Solution:
LAS, Inc. conducted on-site interviews with laboratory management, scientific staff, administrative staff and major users of ATF laboratory data and forensic examination services to analyze all aspects of laboratory operations. Functions examined included sample and evidence receiving, chain of custody, evidence processing, inventory tracking and management, work scheduling, analytical processes, data reporting, internal monitoring, quality assurance and control, database integration, human resource functions, equipment inventory monitoring, equipment operator certification, and client interfaces.

Using information elicited during the interviews, LAS, Inc. produced the following documents:

• As-Is Review: A description of key laboratory tasks as they currently exist including detailed process flow diagrams that provide a graphical representation of who performs the tasks, the relative order of the tasks, how the tasks are synchronized, how information flows to support the tasks, and how tasks are tracked.
• To-Be Requirements Document: A comprehensive description of all IT requirements and operational functionality required to support current and future laboratory processes and regulatory requirements.
• Requirements Matrix: a comprehensive matrix of prioritized system requirements and LIMS features required by the Office of Laboratory Services to be included as part of the RFP.
• Request for Proposal (RFP) Document based on the ATF format and in compliance with ATF procurement guidelines.
• LIMS Market Evaluation: An analysis matching ATF’s requirements set to the current COTS LIMS product market. The analysis listed the 6-10 LIMS products most closely matching ATF’s requirements and quantitatively ranked the available products.
• Demonstration Script: A script based upon functions routinely performed by ATF laboratory personnel, both forensic and regulatory, to be followed by all vendors when demonstrating their products. Required functional and operational processes
• Various Program Management Documents

LAS, Inc. facilitated the ATF review of the received proposals received which culminated in a unanimously supported identification of the top four proposals which were further evaluated during a live demonstration evaluation.

LAS, Inc. hosted the LIMS Vendor demonstrations where as many as 35 ATF employees quantitatively evaluated the four LIMS products. By requiring all vendors to follow a written script with test data provided by LAS, Inc. , all vendors performed the same functions in the same order resulting in easily comparable evaluations by ATF attendees. LAS, Inc. entered the evaluation scores into a normalized and weighted evaluation tool and led the selection decision process, resulting in the selection of the single product scoring highest by more than 85% of the ATF participants.

LAS, Inc. sub-contracted with the LIMS vendor selected by the ATF and managed the LIMS implementation. The following tasks were completed by LAS, Inc.:

• Authored documents required by ATF system implementation and software development life cycle regulations
• Conducted regular status calls with LIMS vendor
• Submitted weekly status reports to ATF
• Reviewed all updates and patches from the vendor
• Developed LIMS Test Plan and Test Scripts
• Guided and participated in user acceptance testing
• Authored system administrator and end-user training materials
• Conducted 40 hours of end-user train-the-trainer

Requirement:
Assist MWRA in specifying and purchasing a Laboratory Information Management System (LIMS). The Department of Laboratory Services (DLS) is a 60-person, multi-site laboratory that serves the operators of water and waste water systems in the Boston, MA metropolitan area by providing chemical and biological analysis of constituents in potable and non-potable waters, soil and sludge.

Solution:
LAS, Inc. performed a comprehensive needs assessment for MWRA that included interviewing laboratory staff, operational personnel, IT staff and end users of laboratory data. LAS, Inc. reviewed and evaluated all aspects of the laboratory operations and MWRA enterprise needs and requirements. LAS, Inc. delivered MWRA’s needs assessment documents in three separate parts – technical specifications, functional specifications, and enterprise specifications – which were later included as the specifications portion of the MWRA LIMS RFP. The document included information concerning implementation timelines required, data migration requirements from their existing in-house built LIMS, hardware infrastructure and software operating environments, instrument and enterprise integration requirements, support requirements/warranties, reporting, etc.

LAS, Inc. evaluated the LIMS vendor market and compared the MWRA needs documents to the products and vendors available in the industry. LAS, Inc. provided MWRA with a short list of potential vendors to evaluate for further review. The list contained product capabilities, available functionality, operating systems and databases used, and a list of known customers for each vendor.

LAS, Inc. prepared a vendor demonstration script that will be followed by vendors selected for this phase. The script will ensure that the selected vendors demonstrate – in the same order – the functionalities required by MWRA.

Requirement:
Assist the New Mexico Department of Health (NM DOH) Scientific Laboratory Division (SLD) select a fully functional LIMS to facilitate the laboratory’s efforts to meet its regulatory requirements under the Clinical Laboratory Improvement Act (CLIA), Health Insurance Portability and Accountability Act of 1996 (HIPAA), and EPA Regulations as well as its responsibilities to the Centers for Disease Control and Prevention (CDC). In addition to the NM DOH, the 120-person SLD serves the Office of the Medical Investigator, the New Mexico Department of Agriculture Veterinary Diagnostic Services Division, the New Mexico Department of Environment, and local and tribal law enforcement agencies.

Solution:
LAS, Inc. conducted on-site interviews of laboratory management, scientific staff, administrative staff and major users of SLD data in order to analyze all aspects of laboratory operations. Functions examined included sample receiving, processing, tracking and management, work scheduling, analytical processes, data reporting, internal monitoring, control charting, instrument interfacing, chemical inventories, status monitoring, quality assurance and quality control, database integration, human resource functions, equipment inventory monitoring, equipment operator certification, and client interfaces.

Using information solicited during the interviews, LAS, Inc. produced the following documents to be incorporated into a Request for Proposal:

• As-Is Review: A description of key laboratory tasks as they currently exist including detailed process flow diagrams that provide a graphical representation of who performs the tasks, the relative order of the tasks, how the tasks are synchronized, how information flows to support the tasks, and how tasks are tracked.
• To-Be Requirements Document: A comprehensive description of all IT requirements and operational functionality required to support current and future laboratory processes and regulatory requirements.
• Business Process Review: A document that 1) identified inefficiencies and inconsistencies within SLD and 2) recommended changes that could be made before and/or during the implementation of a LIMS to improve laboratory performance in meeting the needs of its clients.

This project is still on-going. Future LAS, Inc. deliverables include:

Request for Proposal (RFP):
Document based on the State of New Mexico RFP template.
Requirements Matrix:
a comprehensive matrix of prioritized system requirements and LIMS features required by SLD to be included as part of the RFP.
Vendor Market Analysis Report:
An analysis matching SLD’s requirements set to the current COTS LIMS product market. The analysis will list the 6-10 LIMS products most closely matching NM DOH’s requirements and quantitatively analyze and rank the available products.
Demonstration Scripts:
A script based upon functions routinely performed by SLD to be followed by all vendors when demonstrating their products. Requiring the vendors to follow a demonstration script allows comparisons equally and fairly based upon a prescribed set of functions specific to the RFP.

In addition, LAS, Inc. will provide assistance and guidance to SLD in evaluating vendor proposals and demonstrations to enable SLD to select the LIMS best suited to its operational and business requirements.

Requirement:
Assist Onondaga County in selecting a single, commercial-off-the-shelf (COTS) laboratory information management/evidence tracking system (LIMS/ETS) that will simultaneously support and provide its law enforcement agencies, District Attorney's Office, Medical Examiner, Probation Department and Forensic Laboratory with state-of-the-art automation and communication capabilities.

Solution:
LAS, Inc. conducted a comprehensive needs assessment of the law enforcement agencies, DA's Office, Medical Examiner's Office, Probation Department and Forensic Laboratory to determine: process flow, structure, function and capabilities, IT infrastructure integration and compatibility issues, the ability and benefit of integrating instruments into a LIMS, and current and planned usage of digital imaging, as well as to evaluate their current and future LIMS/ETS needs. The needs assessment consisted of interviews of key personnel in each agency for information gathering purposes and to determine each agency’s requirements and priorities. The information obtained from this requirements elicitation was reported to OCNY in a Needs Assessment document.

LAS, Inc. provided a detailed project schedule and work plan included milestones, and gave levels of detail, to include internal and external resource requirements, with projected start and finish dates and interdependencies of deliverables. The plan delineated the project critical path tasks. LAS, Inc. also provided recommendations on re-engineering opportunities, qualified and quantified efficiencies potentially gained by the implementation of a comprehensive LIMS/ETS, and produced a comprehensive cost/benefit analysis for the purchase, implementation and maintenance of a LIMS/ETS.

LAS, Inc. used the needs assessment document to prepare a Request for Proposal for a LIMS/ETS vendor. After approval by OCNY, LAS, Inc. surveyed the LIMS/ETS vendor market and identified 12 vendors that most closely met OCNY’s needs. LAS, Inc. served as the Point of Contract for the RFP by distributing the RFP to these vendors and requesting detailed proposals for further evaluation. Based upon the proposal responses, OCNY selected four vendors to present a demonstration of their product to evaluators from each of the OCNY stakeholders. LAS, Inc. prepared a vendor demonstration scripts based upon functions routinely performed by SLD. The script ensured that the selected vendors demonstrated – in the same order – the functionalities required by OCNY. Full day vendor demonstrations were conducted with LAS, Inc. oversight. OCNY evaluated the demonstrated performance of the LIMS/ETS using a scoring tool developed and provided by LAS, Inc.. The use of a script and the associated scoring tools provided for an equal and fair comparison of the demonstrated products. OCNY is currently using the results of the scripted demonstrations with their evaluation of the vendor RFP responses and the cost proposals to select the vendor for their project.

Requirement:
Assist the New York City Department of Health and Mental Hygiene Public Health Laboratories (NYCDOHMH PHL) in selecting and implementing a Laboratory Information Management System (LIMS) as part of an ongoing program to improve efficiency in their laboratories.

Solution:
LAS, Inc. performed initial work for NYCDOHMH PHL on an accelerated schedule at their request. The initial contract with NYCDOHMH PHL involved a full User Requirements Definition / Needs Analysis, Hardware & Software Determination Assistance, Business Process Inconsistency Documentation, Request for Proposal (RFP) development, delivery of Vendor Selection Tools and Documentation (including development, scoring, and oversight of Vendor product demonstrations) and development of the Implementation Plan. The work was successfully completed in less than four months and exceeded NYCDOHMH PHL expectations.

The completion of LAS’ initial task was on time and within budget and resulted in a follow-on contract for full Project Management and installation support of the chosen LIMS implementation over a 22-month period, commencing in May 2004. During this time LAS was on-site every day providing expert advice and hands-on assistance. LAS provided certain key deliverables routinely and other documents on an as-needed basis.

The tasks and deliverables associated with the current contract include those specifically requested by NYCDOHMH PHL and some suggested based upon LAS, Inc.'s experience. The key deliverables included:

• Updated Project Implementation Plan: Specified in the Statement of Work with one delivery to NYCDOHMH PHL Project Management
• Daily working papers / system documentation: Specified in the Statement of Work and delivered to Project Management as they are generated. Examples of working papers and system documentation are:
  • Written, end-user specific standard operating procedures for all disciplines
  • LIMS end-user testing scenarios and results data to include integrated systems (analytical instruments, other hardware) and HL 7 messaging.
• Project Schedule Updates: Specified in the Statement of Work as weekly updates. Verbally changed to monthly updates to NYCDOHMH PHL Project Management
• Project Timecards: Not specified in the Statement of Work but requested formally as part of an internal project audit and delivered weekly to NYCDOHMH PHL Project Management.

The NYCDOHMH PHL was so pleased with the work LAS, Inc. performed that two additional contracts were let during the same timeframe to LAS, Inc. including assistance to Complete Certification Requirements for CLEP using NELAC standards and the Pandemic Flu / Surveillance and Specimen tracking project.

Requirement:
Assist the University of Missouri Veterinary Medical Laboratory (VMDL) in developing a Quality System to meet the requirements of the American Association of Veterinary Laboratory Diagnosticians (AAVLD) Essential Requirements for an Accredited Veterinary Medical Diagnostic Laboratory.

Solution:
LAS, Inc. personnel wrote the AAVLD-required Quality Manual for VMDL at a time when VMDL did not have its own Quality Assurance Officer. LAS, Inc. interviewed supervisory and administrative personnel to obtain information specific to VMDL procedures and used our knowledge of the AAVLD Essential Requirements to write the Quality Manual.
After the University of Missouri VMDL appointed a Quality Assurance Officer, LAS, Inc. trained this person, as well as laboratory and administrative supervisory staff, on the AAVLD Essential Requirements and on how to write compliant Standard Operating Procedures (SOPs). LAS, Inc. continued to provide assistance by writing, reviewing and/or revising 24 system SOPs and associated forms for VMDL.

Requirement:
Plan and manage all tasks associated with writing a Statement of Work (SOW) to be used by VHA for soliciting a formal proposal from vendors for developing an enterprise-level Laboratory Information Management System (LIMS) that will support all disciplines of the laboratory system, as well as comply with all regulatory agencies overseeing laboratory and hospital information systems. The VHA supports approximately 300 clinical laboratories and employs over 220,000 people; approximately 7,000 of those resources are laboratory employees.

Solution:
The project consisted of four major tasks:

For Task 1, LAS, Inc. developed a project charter and a project plan for managing the other three tasks. The project plan included the schedule, deliverables, dependencies, scope management, risk management, communication plan, resource plan, change management and quality assurance plan.

Task 2 required LAS, Inc. to identify and assess gaps in the LSRP project (e.g. the previously developed vision document, stakeholder requests, requirements management plan, and risk management plan), as well as identify additional information required to effectively prepare a SOW that would align with the VHA business practices and mission. The task culminated with LAS, Inc.’ development of a Gap Analysis document that included a Strength, Weakness, Opportunity and Threat (SWOT) analysis with recommendations for maximizing VHA strengths, minimizing VHA weaknesses, taking advantages of opportunities, and addressing threats to ensure successful development of the SOW and RFP.

During Task 3, LAS, Inc. performed marked research and evaluated previous responses to a Request for Information (RFI) issued by VHA. The resulting document produced by LAS, Inc. identified ‘Best of Breed’ LIMS vendors based on their technical expertise and historical adoption of new technologies, software development and implementation practices, company profile, and existing customer base and profiles.

For Task 4, which was the main goal of the project, LAS, Inc. developed the SOW that would support VHA strategic goals for Pathology and Laboratory Medicine Services; comply with government RFP requirements; support VHA LSRP goals standards and guidelines; and contain performance measures that meet LSRP objectives. LAS, Inc. accomplished this task by researching several LSRP documents including: the LSRP vision document, stakeholder requests, requirements management plan, use cases, and risk management plan, as well as several other VHA documents and non-VHA documents such as the Association of Public Health Laboratories (APHL) Requirements for Public Health Laboratory Information Management Systems. LAS, Inc. organized the SOW along the lines of an RFP and included the following sections:

• Project background
• VHA services structure
• Requirements for proposal preparation, delivery and review
• Requirements for installation, training and support
• Software/infrastructure boundaries
• Current operations overview
• Required functional and operational processes

Requirement:
Guide the Bureau of Alcohol, Tobacco, Firearms and Explosives Fire Research Laboratory through a controlled requirements elicitation process, proposal evaluation process, proposal selection process, system configuration process, system implementation process, and system testing process. Fire Testing and Operations System (FireTOSS) is a unique fire research management tool that is able to collect fire-related data and video from multiple research rooms in the ATF Fire Research Laboratory. The largest room can hold a multi-story, multi-room building and collect as many as 2000 measurements each second continuously for multiple days as a fire starts and spreads.

Solution:
LAS, Inc. conducted a modified requirements elicitation and, after an intensive ATF review, released the RFP to a broad set of data acquisition vendors. The final product focused on moving the requirements from "how to create" to "functions." Newly-discovered and developed requirements allowed for the use of COTS-based solutions. The RFP was based on the ATF format and in full compliance with ATF procurement guidelines. Finally, LAS, Inc. hosted a pre-bidders conference to provide additional insight to vendors about the unusual laboratory environment and novel approach to data acquisition.

LAS, Inc. facilitated the ATF review of the proposals received and guided the evaluation committee to a unanimous acceptance of the selected vendor. LAS, Inc. sub-contracted with the data acquisition vendor selected by the ATF and managed the FireTOSS implementation. The following tasks were completed by LAS, Inc.:

• Authored documents required by ATF system implementation regulations
• Conducted regular status calls with data acquisition vendor
• Submitted regular status reports to ATF
• Reviewed all updates and patches from the vendor
• Led problem resolution processes focused on resolving performance and data accuracy problems caused by errors in the Fire Research Laboratory network
• Developed FireTOSS Test Plan and Test Scripts
• Guided and participated in user acceptance testing