laboratory information management system (lims) project ... · 11/28/2007 · laboratory...

Laboratory Information Management System (LIMS) PROJECT

New Mexico Department of Health

Independent Verification and Validation

IV&V Periodic Review Report (IM-4)

Revision 1

Submitted June 19, 2007

Submitted by

Bency & Associates

10555 Montgomery Northeast Building 2 Suite 110

Albuquerque, NM 87111

Quality is the Difference

New Mexico Department of Health – LIMS Project LIMS IV&V Seventh Periodic Review IM-4

Bency & Associates, LLC of 23

IV&V Reporting History:

Dates of the contracted reports are set from the date of the Project Kick-Off Meeting, March 27, 2006 and follow the time periods as set in the contract from there. Any other reports requested will be provided as appropriate to the project and review needs, and per contractual terms.

Report/Activity

Date Submitted

Comments

IV&V Management Plan – IM-1 4/7/2006 Delivered Initial Risk Assessment – IM-2 4/7/2006 Delivered IV&V Management Plan – IM-1 and Initial Risk Assessment – IM-2: Revised and Updated

4/14/2006 Delivered

Initial Review – IM-3 4/19/06 Delivered Management Briefing # 1 – IM-5 12/19/06 Delivered First Periodic Review – IM-4 5/8/06 Delivered Second Periodic Review – IM-4 6/7/06 Delivered Third Periodic Review – IM-4 7/10/06 Delivered Fourth Periodic Review – IM-4 (final periodic) 8/7/06 Delivered Fourth Periodic Review – IM-4 REVISED 8/11/06 Delivered Fifth Periodic Review – IM-4 11/6/06 Delivered (Contract #

07.665.0001.0004) Management Briefing # 2 – IM-5 (Best Practices: RFP Evaluation, Contract Development & Contract Execution)

12/19/06 Delivered (Contract # 07.665.0001.0004)

Sixth Periodic Review – IM-4 1/2/06 Delivered (Contract # 07.665.0001.0004)

As-Is, To-Be and BPR Document Reviews 6/23/06 Delivered LIMS Requirements Matrix Document Review 12/1/06 Delivered (Contract #

07.665.0001.0004) LIMS RFP Document Review 12/6/06 Delivered (Contract #

07.665.0001.0004) LIMS Market Research Analysis Report 1/25/2007 Delivered (Contract #

07.665.0001.0004) LIMS Demo Scripts 4/18/2007 Delivered (Contract #

07.665.0001.0004) Seventh Periodic Review – Substituted for the deliverables in blue below

6/15/2007 This Report (Contract # 07.665.0001.0004)

Vendor Short List for RFP LIMS Vendor Selection Will not be provided or

billed. LIMS Implementation Contract (must be completed by June 30, 2007) No submission yet.



Executive Summary:

This Independent Verification and Validation Report (IV&V) report covers the months of March through May, 2007. This report completes the periodic reviews of the LIMS Procurement under this contract. A final report will be provided addressing the LIMS contract /scope of work with the vendor that is ultimately selected from this process. Activities for this periodic review are summarized as follows.

Activities Completed this Period • Attended LIMS Project Steering Committee Meeting on March 14, 2007 • Attended LIMS Project Steering Committee Meeting on April 11, 2007 • Attended LIMS Project Steering Committee Meeting on May 22, 2007 • Completed and Delivered IV&V Review of LIMS Demonstration Scripts on 04/18/2007 • Attended a portion of one Vendor Demo in progress. • Provided this review report.

Final Activities: • Attend LIMS Project Steering Committee Meeting on June 19, 2007. • Review Vendor Contract and provide a final report.

Analysis of Project Status The LIMS procurement process is in the final stages. The proposals were received, evaluated and two vendors out of five were selected to provide demonstrations of their product(s) to meet the functional requirements of the system. The LIMS RFP was posted on March 23, 2007 by State Purchasing, over three months behind the originally planned schedule. However, when the procurement process began to take shape and realistic forecasts and dates could be assigned, Deborah Dickerson submitted a revised project plan at the March 2007 Steering Committee. Since this plan was submitted, all activities from that point have progressed in relation to the revised schedule and the evaluation team is currently deliberating their selection. The plan has held very close to schedule and all tasks have been completed in that order.

The LIMS Project Steering Committee met in March, April, May, and are scheduled for June. The team had to cancel the February meeting because of weather. The steering committee continues to be actively engaged in risk management, key project deliverable approval, budget management, and issue management activities. They have been a strong force in keeping the procurement phase moving and have been most helpful in supporting the procurement manager and project manager when extra effort was necessary. The major accomplishments this period were:

o The RFP was issued.

o Five vendors responded. Two finalists were selected to provide demonstrations of their system.



o The evaluation committee is currently in the process of vendor selection.

The project schedule for the procurement slipped more than three months due to the time required in finalizing the Requirements Matrix which is the cornerstone of the RFP, and the procurement process in general. Once the procurement began with the RFP, the timelines established for the process have held very well! Acknowledgement and gratitude are extended to Mary Houdek, who helped move the document forward to full approval and posting, with excellent communication to stakeholders on the progress. Project expenditures over the period included payment for IV&V deliverables, payment for LAS deliverables, and salary expenses for the LIMS project manager. Overall, project expenditures for the current fiscal year are lower than anticipated due to project schedule slippages. Most procurement activities are completed and the fiscal year is at an end. Hardware purchases for the BT grant must be completed by July 20, 2007, and funds were encumbered to move to FY2008. It was anticipated that the evaluation committee would make its recommendation on June 1, with the EC report to be completed by the end of June for submission of the contract to state purchasing. Negotiations will begin once the selection was made.

The current project manager, Deborah Dickerson, has been promoted to Bureau Chief and will be finding a replacement for her position during the Implementation Phase. Congratulations to Deborah on her new position. She has demonstrated her superior qualifications through the examples of her project management style and organizational skills. She will continue to be an asset to the Department.

Significant Findings & Pertinent Recommendations

New Findings/Recommendations

Each month, findings/issues and recommendations for the current reporting period will be summarized in Table 1: New Findings/Issues and Recommendations. Findings/issues and recommendations from prior reporting periods will be contained in Appendix D: IV&V Issues Log. Summary statistics for previous issues will be presented in Table 2: Statistical Summary of Prior Findings/Issues. Table 1: New Findings/Issues and Recommendations

New Finding/Issue Bency & Associates Recommendation None this reporting period.

Statistics on Prior Findings and Recommendations

Table 2 provides a statistical summary of previous findings/issues (excluding current period findings). Please see the IV&V Issues and Recommendations Log (page 10) for details.

Table 2: Statistical Summary of Prior Findings/Issues

Potential Impact # Open # Closed

# Severe 0 3

# Moderate/Mild 0 6



IV&V Periodic Review:

This Periodic Review is based on the reading of documents available to date and attendance at the LIMS Project Steering Committee meetings, and any other communications with the project manager and sponsor.

Risk Management Plan:

Risks have been updated for the current activities and have been closed. The procurement is in the evaluation stage of vendor selection, and planning for implementation will begin. This will bring additional analysis of project risks other than those that are identified in the current plan and more relevant to the next phase.

Project Schedule:

A revised project work plan was submitted for review in March 2007 to the Project Steering Committee. The process has followed this revised plan and the schedule has held very well with very minor lapses. Additionally, a comprehensive “sequence of events” was provided that has been followed as well. The final task in the plan is to finalize the contract, once vendor selection is made.

Project Status Reports: The DOH IT Project Dashboard Reports for the months of March through May were submitted to the IV&V consultant for review. The reports describe the status of the project in terms of issues, deliverables, schedule and budget.

Schedule: Schedule slippage continued and will until the Contract is signed, thus ending this Phase of the project.

Vendor Deliverables Discussed: The status reports indicate that the vendor has been an excellent asset to the procurement of the system and desire their expertise during the Implementation phase. It is very much agreed they delivered thorough materials and requirement recommendations.

Risks Discussed: Funding may be lost due to RFP delays

Budget: Project spending is lower than expected and reflects the gap in time when LAS was without a contract and was not submitting deliverables and associated invoices. The Project Spending Table below represent figures through May 15, 2006.

Project Spending Table: Project and Current Fiscal Year to Date as of May 2007

Fiscal Year 2007 Budget

Fiscal Year 2007 Expenses

Variance

$149,959

$92,674

(61% of budget)

$57,285

(38% of budget)



Project Steering Committee Meeting Minutes: Minutes were provided for March, April and May 2007. The IV&V specialist attended the March and April meetings. March 2007 Steering Committee Meeting:

• Attendance – 6 out of 10 committee members attended the meeting. • Vendor Deliverables Discussed – • Risks Noted – Funding was discussed and the amount of $70,000 was currently

reserved for servers. There was also concern over loss of funding due to schedule slippage.

• Schedule and Budget Review – Mary Houdek provided a schedule of the RFP process and she indicated that she would keep it moving. Deborah Dickerson provided a revised project plan that reflects realistic dates for the remainder of the Procurement process.

April 2007 Steering Committee Meeting:

• Attendance – Seven (7) out of ten (10) committee members attended the meeting. • Vendor Deliverables Discussed – Vinnie will deliver a report after reviewing the

Vendor Demo Scripts • Risks Noted –The RFP is on track now. Proposals due to be received. • Schedule and Budget Review - The Project Manager noted the milestone dates that

have been pushed out since the last committee meeting. • Discussion – The Demo Script is 8 hours long and will not be revised.

May 2007 Steering Committee Meeting:

• Attendance – Six (6) out of ten (10) committee members attended the meeting. • Vendor Deliverables Discussed – N/A Did discuss LAS’s role on LIMS project after the

current contract ends. LAS is currently under GSA contract. Everyone is very happy with the work performed and would like to continue to have their expertise through implementation.

• Risks Noted –No Risks or Issues • Schedule and Budget Review - The Project Manager noted the BAFO’s were due on

May 22, 2007 from the finalist vendors. Letters were sent letting all vendors know if they were finalists or not. Kelly from LAS flew out for the initial review of the proposals in early May. Vendor demos for the two finalists were scheduled for May 29 and 30. LAS would proctor the demos and provide analysis, post-demo.

• Discussion – The need for internal IT support and what is needed for implementation and on-going support.

• Decisions – SLD will continue to work with LAS through implementation. • Hardware – Server locations – primary in SIMMS, back-up in ABQ. The committee is

very concerned about connectivity and speed based on their current experiences with SHARE. Vicki Gottlieb suggested they wait and see what happens with DOIT. Bency Recommendation: Make this a focus during the pilot phase and specifically stress-test the system from various points and communication methods for system performance.



Conclusion:

Overall, this phase of the project, the Procurement, moves to completion. Thus far the documents, plans, evaluation tools and requirements identification are of high quality and the team, led by the project manager, has managed to get this phase to the final vendor selection process. As indicated above, the original schedule slipped due to the importance in assuring the requirements were complete prior to issuance of the RFP and the overall procurement process in place for the State in general. Since the revision of the plan, this process has proceeded extremely well since the RFP was posted. Overall, the project is on schedule according to the revised project plan. Funding has been encumbered/extended into FY08 so that the project can proceed smoothly. All the best is extended to the Project team and various committees for a successful contract and implementation! The following documents have been attached as reference to the project. Appendix A - IV&V Risk Assessment (Updated) Appendix B1 - LIMS Project Steering Committee Minutes (March - May ) Appendix B2 - LIMS Project Steering Committee Minutes (March - May) Appendix C – LIMS Project OCIO Dashboard Reports (March - May) Appendix D –LIMS Project Schedule (March) Respectfully Submitted By: _______________________ Vinnie Gerecke

Date: June 15, 2007



Documentation Status Summary:

The following list is documentation which can aid in the assessment and review of the LIMS project. As these are available they will be reviewed as part of the IV&V activities.

Requested Documentation Delivered Documentation Date Delivered

• SLD State and Federal Audit Reports

State and Federal audit reports for the past approximately 2 years

3/13/06

• LAS (vendor) Contract LAS Contract 3/20/06• Process flows as-is As-is work flows 5/1/06 thru

6/6/06• Process flows to-be, and final

to-be document To-Be proposed and revised documents 6/26/06

• LIMS Business Process Recommendations

LIMS Business Process Recommendations 6/8/06

• Project Appropriations documents (General Appropriations Act 2005)

Available from the New Mexico Legislature Web Site. http://legis.state.nm.us/Sessions/05%20Regular/final/HB0002.pdf

4/17/06

• Project Sponsorship (PM-1, PM-2) such as a project charter or similar document

see statements above 6/6/06

• PM-6 Project Management Plan

Project Management Plan 3/20/06

• PM-8 Milestones and Dates (Implementation Schedule)

LAS Contract Project Kick-off Schedule MS Project Schedule (original) MS Project Schedule (revised) MS Project Schedule (revised) MS Project Schedule (revised)

3/20/063/27/06

5/1/06 8/8/06

10/25/0612/7/06

• PM-9 Issue Tracking Web-based issue repository 7/31/06• PM-12 and PM-13 Business

Process Reengineering LIMS Business Process Recommendations 6/8/06

• PM-15 Risk Management Plan Risk Management Plans (LIMS001 – LIMS007) 6/6/06• Monthly Status Reports DOH IT Project Dashboard Reports *these are

being delivered regularly • Requirements Matrix LIMS Requirements Matrix 11/27/06• RFP LIMS RFP 11/28/06• Demo Scripts Demo Script Evaluation Report 04/07• Vendor Market Analysis Vendor Market Analysis Report 01/25/07• Vendor Evaluation Tools

(product ranking) Discussed in Demo Script Evaluation Report. Not necessary to present as a separate document, thus saving funds for applicable tasks.

01/25/07

http://legis.state.nm.us/Sessions/05%20Regular/final/HB0002.pdf

http://legis.state.nm.us/Sessions/05%20Regular/final/HB0002.pdf

New Mexico Department of Health – LIMS Project LIMS IV&V Seventh Periodic Review IM-4 IV&V Issues and Recommendations Log:

(Shaded are closed). Also see Appendix A: IV&V Risk Assessment for identified risks.

Finding/Issue #

Date Open

Impact - Severe

- Moderate - Mild

Finding/Issue Bency & Associates Recommendation

Status - Open

- Closed

DOH Response

Rec1 4/7/06 Severe Risk Management Planning

It is recommended that a Risk Management Plan be fully developed now, and that the risks so far identified be managed by that plan.

Closed 6/6/06

Rec2 4/7/06 Moderate Communications and educational information about LIMS for staff

It is recommended that special communications and/or educational efforts about LIMS be developed and continued throughout the duration of both this immediate project (product selection) and the subsequent project (implementation).

Closed This area is being addressed by the steering committee. As formal activity is put into place, this item will be closed.

Rec3 4/19/06 Severe Implementation Schedule It is recommended that an Implementation Schedule be created for tracking and guiding progress in this project. This can be reported against in regular meetings. It should include resources with each task, and, where appropriate, approval and availability of funding necessary for both this selection project and the eventual implementation project.

Closed 5/1/06

DOH has created and provided an Implementation Schedule.




Finding/Issue #

Date Open

Impact - Severe

- Moderate - Mild


Status - Open

- Closed

DOH Response

Rec4 5/8/06 Moderate Schedule changes The LIMS Steering Committee document and accept the schedule change as shown in the project schedule (from the original contract) formally and reflect that acceptance in it’s minutes.

Closed 6/6/06

Most recent steering committee minutes reflect addressing this issue, and acceptance of the revised schedule. The committee is aware that the schedule now in effect is aggressive, and will require close management to meet.

Rec5 6/26/06 Moderate1 Issues Tracking mechanism

Establish an Issues Tracking tool and process, begin using now to help familiarize the steering committee and project team(s). This will address IV&V review item PM-9.

Closed 7/31/06

An Issue tracking method and documents have been developed and provided for IV&V review.

Rec6 8/7/06 Moderate Scripted demos Require finalist vendors to present from scripted demos, as it offers other benefits besides final selection, such as an opportunity to see features and functions and how those will serve the needs of SLD. Without the demos, SLD is making assumptions about how the product will function and fill those needs.

Closed 1/2/07

The Steering Committee has decided to utilize a 1/2 day scripted demonstration process instead of a 1 or more day demo process for finalists. The selected vendor will be required to conduct a full (1-2 day) demo as part of the contract negotiation process.

Rec7 11/6/06 Severe The project schedule has slipped two months and funds that expire on June 20, 2006 may be lost

Bency & Associates supports the decision of the LIMS project to request language in the General Appropriations Bill for 2007 to carry forward funds from the FY07 to the FY08 Department budget for purposes of completing the current phase of the LIMS project.

11/16/06 The Steering Committee has decided to request language in the General Appropriations Bill for 2008 to carry forward funds. (this issue will remain open until the legislative session ends in March 2007)

1 This is Moderate at this time, as the issues during vendor selection are minimal. However, this should be in place and functioning prior to the implementation project starting, when it will become Severe.



Finding/Issue #

Date Open

Impact - Severe

- Moderate - Mild


Status - Open

- Closed

DOH Response

Rec8 8/7/06 Moderate The time periods for external agency review of procurement documents may be too short

Bency & Associates recommends that the time periods allotted for review of project deliverables (e.g. RFP, Contract) by external agencies be examined and revised if necessary to reflect current practice.

12/7/06 The 12/7/06 version of the project schedule allows 11 days for external approval of the RFP and 23 days for external approval of the vendor contract

Rec9 8/7/06 Moderate Costs related to customizations may not be fully captured in responses to the RFP

Bency & Associates recommends that the LIMS RFP require bidders to break out costs for any customizations that are needed to fully satisfy mandatory and highly desirable system requirements.

7/31/06 The RFP’s cost response form requires bidders to break out costs for optional capabilities (e.g. off-site hosting, document management) and to specify hourly rates for additional customizations and reports. Each bidder must specify a fixed base system price to cover all mandatory system requirements.



APPENDIX A

IV&V Risk Assessment

(Updated)



Project Risks Identified by IV&V Initial Risk Assessment:

These tables list project Risks identified as part of the IV&V activity. These are based initially on descriptions of the project and on any documentation delivered to date. Items will remain open until the risk is clearly mitigated, or a response (written or submitted documentation) indicates the item is no longer a risk to the project.

Shaded items are considered closed.

Yellow Highlighted are new comments.

Client identified risks:

# Risk Description

(Client Identified Risks)

Probability High, Medium

or Low

Impact High,

Medium or Low

Closure Date

Delay in approval of Social Services Architecture leading to loss of financial resources High High

C1 DOH Response: Yes, it has been approved. This is no longer an active risk. But we did lose about $100,000 due to the delay in approving the SSA.

4/13/06

CDC Funding not available for Project Low High

DOH Response: We currently have about $400,000 in CDC funds for this project. The critical point with CDC funds will come in the next funding cycle when we will need about $1,000,000 to finish the project (i.e., implementation)

C2

IV&V: The funding status is being addressed, but this should remain an open an active risk until fully resolved. DOH is actively working on this and, along with other risk items, should be regularly reported on to the steering committee. The General Appropriations Act 2005 (HB0002) has included the following funding for the LIMS implementation, under Section 7, Data Processing Appropriations: [Line Item] (23) DEPARTMENT OF HEALTH: $1,900,000: “To implement a single, integrated laboratory information management system. This appropriation is contingent upon an approved social services architecture plan.” Of this amount, $1,000,000 is state funds and $900,000 is federal funds. [Note: The social services architecture plan has been approved.] This item is closed in preference of the new risk items and being consistent with the project teams’ management of risks.

6/6/06

Contingency Plans for Project participations impacted by an external event Medium High

C3 IV&V: External events should be identified individually and mitigation plans created as appropriate for each. This risk is too general to manage or mitigate as a specific item. Identification can be done as a team effort. Steering committee is taking responsibility for this risk as a regular part of its meeting agendas.

5/3/06

Overall place of project in DOH Planning Low Medium C4

DOH Response: This is a general risk for all DOH projects. The Department’s priorities shift over time. Those changes can result in a project losing support and resources. The current specific risk is that DOH’s IT Division has limited resources, other projects could co-opt the resources that we have available today. DOH doesn’t have any documentation that ranks or prioritizes projects.



# Risk Description



or Low

Impact High,

Medium or Low

Closure Date

IV&V: Since this project is driven to a large extent by regulatory audit recommendations, DOH can maintain the priority profile of this project through the project sponsor and regular communications with the steering committee, stakeholders, and state administration. In addition, discussion about adequate resources should begin now. This should remain open and managed along with other risks until such time as mitigation has the project solidly placed and supported in DOH priorities.

Participation and responsiveness of Steering Committee Low High

DOH Response: This is another generalized risk. The Department has had a number of projects that have struggled because of lack of Steering Committee and Project Team participation. At this time the LIMS Steering Committee is highly involved and responsive. I don’t see that changing. I think there is a risk with the project teams. We haven’t pulled those together yet, but we may have some conflicts between there current workload and project responsibilities.

C5

IV&V: Same comments as above (C4). Steering committee is being proactive in managing this project as show by its recent meetings.

5/3/06

Participation and responsiveness of Project Team Low High

C6 IV&V: Same comments as C4. At the start, this is seen to be good, but should be watched over time. Closed with respect to carry-over to new risk list.

6/6/06

Project resource availability for system lifecycle High High

Does this refer to staff turnover? Is this Lab staff, IT staff, or both? Or does this refer to another concern? DOH Response: All of the above [staff turnover, Lab staff, IT staff], but most specifically to DOH IT infrastructure staff (network and data center staff). DOH is thinly staffed in these areas. I’m concerned about having the right number of committed, skilled IT project team members from DOH when we implement. Currently I’m overtasked. In addition to LIMS I’ve got project manager responsibilities on another major project, the Statewide Immunization Information System (SIIS) project, plus a number of other, smaller, projects. SIIS is a temporary assignment but its impacting my work on LIMS.

C7 IV&V: Start planning now for what the team structure and time commitments will look like. LAS may be able to provide some guidance in this area. For an implementation of the size expected, there will most likely need to be a core team of staff with at least 70%-80% of their time dedicated to the implementation. Other staff will be involved to varying degrees and times, depending on the area and aspect of the system involved. This will increase as testing and go-live approach. Document these in writing, use other sources (labs that have implemented, vendor experience, LAS experience) to plan around, and communicate this information regularly to DOH and state sponsors. Apply Organization Change Management practices now, including regular communications. Start delineating needed training for key project team members, and training for new staff that includes an understanding of the project and transitions expected. Closed with respect to this being re-addressed in the new risk list.

6/6/06

C8 Delays in procuring goods and services High High



# Risk Description



or Low

Impact High,

Medium or Low

Closure Date

DOH Response: The State and DOH in particular have problems procuring goods and services in a timely manner. A simple contract from a State-wide price agreement is now taking a minimum of 2 months. An RFP usually takes a minimum of 4 months. Anything unusual can take much longer. So if we need some specialized equipment and/or services for this project the time it takes to procure those items may significantly delay the project. There’s really no fix for this, no way to push the system faster. My strategy is to include as much as possible in the RFP we do for the software and installation services. That way we will have a procurement vehicle in place.

IV&V: This strategy is good, and any additional steps to start procurement, or include, as suggested, as much as possible in the RFP.

PHIN Requirements changing scope of project High High

C9 IV&V: Schedules should be created with slack time in key areas, such that time is available if required to address any such changes. This is always a high risk area, since projects of this nature tend to be long in duration, vendors behind the curve in supporting new requirements. Be alert to signs of changes in requirements, and schedule with the intention of being able to accommodate changes.

Conforming to changing Project Management Reporting Requirements Medium Low

C10 IV&V: This should be a minimal problem, and should have little effect. However, developing good reporting tools and methods now and using them as designed will help to mitigate this.

Competition for management resources Medium Medium

DOH Response: The lab will be building a new building over the next few years. The initiation of that major construction project will probably overlap the last part of the implementation phase. C11 IV&V: Encourage DOH and SLD administration to work together and create a strategy to keep these and any other significant projects “on the radar” at all times, so that they can be managed as a “portfolio” rather than individual items.

No software package available with good fit to SLD needs Medium High

C12 IV&V: This probability rating is more likely “Low” based on observations from the kick-off interviews and statements from LAS, since such products have been developed commercially and are in use around the country. Based on LAS’ statements about the number of products which can fulfill SLD needs and requirements, this risk is being closed. SLD does not consider it a risk at this time.

6/7/06

Timing of Funds High High

The LIMS project is a multiyear project yet its funding is allocated annually with no guarantee of future funding. In addition funds are received from different funding sources with different cycles. If funds are not used in their allotted time they may be lost. LIMS-0012

IV&V Comment: Being actively addressed by the Steering Committee. See notes under “Project Funding” above.

LIMS-002 Adequacy of Funds High High

2 The Risks listed as “LIMS-###” are those being actively shown in and managed by the steering committee Risk Management plan. Those shown as “C#” are from the first pass by the client SLD.



# Risk Description



or Low

Impact High,

Medium or Low

Closure Date

The LIMS project is a multiyear project yet its funding is allocated annually with no guarantee of future funding. The project only has committed funding for less than half of the estimated cost of the project.

IV&V Comment: Being actively addressed by the Steering Committee. See notes under “Project Funding” above.

Organizational Change Management High Medium

The successful implementation of the new LIMS system will require significant changes in laboratory management and operational practices. To successfully design and implement those changes requires the cooperation of all Lab staff members.

LIMS-003

IV&V: See notes from Risk OC-1.

Loss of Customers High

In some cases SLD is only meeting minimal customer expectations for data and information delivery. The LIMS project intends to deliver a product that will improve the current set of customer deliverables and meet their needs and expectations well into the future. However customer expectations and needs may exceed SLD’s current capacities before a new LIMS product is implemented.

LIMS-004

IV&V Comment: Being actively addressed by the Steering Committee.

Availability of Staff High High

The LIMS project will require significant amounts of staff time from supervisors and non-supervisial employees. The time demands of the LIMS project will conflict with the demands of the lab workload.

LIMS-005

IV&V Comment: Being actively addressed by the Steering Committee.

Complexity Medium? Low

SLD operations are more complex than most other public sector laboratories. The complexity of the Lab’s operations may make it difficult to identify a product to meet all of the labs needs within the funds available. If an appropriate product is identified then it may be difficult to implement the system in a timely manner or with the necessary quality.

LIMS-006

VDS Partnership (OPPORTUNITY)

Veterinary Diagnostic Services has a current need for an improved LIMS system and has begun the process of analyzing its options. VDS analyzes its own specimens and sends their specimens to other labs, including SLD for analysis. VDS is located in the same building as SLD. LIMS-007

IV&V Comment: This is seen as an opportunity by SLD, as there is the possibility to partner with VDS in order to share resources to support the project.



IV&V Identified Risks:

Definitions: “Impact” means the likely consequences of this risk occurring; “Probability” means how likely this risk is to occur (low, medium, high); “Level” means the degree of impact this risk will have on the project, should it occur (low, medium, high). Each is followed by a suggested Risk Mitigation Strategy. The client can close each of these by showing documentation and/or evidence that it is complete and resolved, and no longer constitutes a risk to the project. It is recommended that documentation be created, maintained and shared towards actively managing each of these.

Shaded items are considered closed.

Strategic – risks relating to the purpose and outcomes of the project.

Date Risk S1 Risk Description Closure None at this time.

Resources – risks relating to availability and skill sets of the project resources.

Date Risk R1 Risk Description Closure Insufficient team resources. Impact: Project work will suffer and be a lower priority for staff than daily responsibilities. Probability: High Impact: High

As also identified by SLD, this risk will impact more the implementation project than the current product selection project. This risk is having insufficient work time allotted to project work due to daily work overshadowing it.

4/7/06

Risk Mitigation Strategy: Risk R1

Explore possibilities including temporary staffing (and funding to support), which would handle much of the daily work while permanent and experienced staff focus on the implementation work. Consider some project staffing from contract sources (including the funding to support) and develop plans now.

6/6/06



Project Management - risks relating to the project management team’s capacity and experience and project management approach.

Date Risk PM1 Risk Description Closure Building a project team. Impact: Inability of the team to fully staff and manage an implementation project resulting from product selection. Probability: Medium Level: High

It should be understood that this risk is NOT immediate to the current product selection project, but that it is a consideration that can be started now towards building a team foundation for the future implementation project.

Risk Mitigation Strategy: Risk PM1

Begin planning now for what a project team should look like, skills required, and so on, for the implementation project. This will support the Organization Change Management Risk OC1 identified below as well.

4/7/06

IV&V Comments: Steering Committee members are aware of the risk and looking at which staff members will become project team members and their responsibilities. These discussions will need to continue as the project moves forward, and should include looking at how those team members time is covered by other staff and/or contract workers.

Technology – risks relating to the technology platforms involved in the project.

Date Risk T1 Risk Description Closure Older lab instruments incompatible with modern LIMS applications. Impact: Unexpected issues with data management; inability to properly utilize LIMS functions; slowing down lab processes. Probability: Medium Level: High

Older, or non-standard, lab instruments may not interface with the LIMS product as expected in some areas. This will create the need for work-arounds, manual input of data, or need to upgrade. It is not clear at this time what instruments may fall into this category.

4/7/06

Risk Mitigation Strategy: Risk T1

An inventory and assessment of all lab instruments which LIMS applications normally expect to interface for data transfer should be conducted. This can be done with the guidance of LAS and the product selection criteria they are developing. Then, steps should be taken to plan for upgrades where appropriate, including financing, and incorporating those into the implementation project.

IV&V Comments (1/2/06):

The RFP includes an inventory of instrument interfaces and asks each bidder to specify an hourly rate for developing interfaces between the LIMS software and the instruments.



Project Change Management / Operational Risk – risks relating to scope, parameter and other changes to the project structure, requirements or deliverables.

Date Risk CM1 Risk Description Closure None at this time.

Organizational Change Management – risks relating to user involvement with and acceptance of the project.

Date Risk OC1 Risk Description Closure Staff understanding of LIMS applications. Impact: Confusion, possible frustration and conflict between different areas within SLD. Probability: High Level: High

Generally, there is a wide disparity of both technical and business understanding of what a LIMS product involves, can provide and will require, as well as the impact it will have on existing processes and functions. Another aspect to this risk is the length of time an implementation may take (projects of this type can range from 12-24 months). While this time span is not required for initial product selection, it is important that the staff understand the implementation process now and what to expect over that length of time.

Risk Mitigation Strategy: Risk OC1

One possible mitigation of this risk would be developing a series of educational “forums” for the SLD management and staff to begin familiarizing them with all aspects of a full LIMS product. This can be done in synch with the LAS deliverables and tools, so the staff’s knowledge grows along with the current project. Additionally, management discussion about organizational changes to expect can facilitate ownership in the project, and create opportunities for addressing concerns as they arise.

4/7/06

IV&V Comments The Steering Committee has discussed this risk, and is looking at possible ways to start creating this now. This risk will remain open until some activity is being put in place around this area. This is being closed here as it is replaced by LIMS-003

6/26/06

Date Risk OC2 Risk Description Closure Staff understanding of how LIMS applications can benefit the organization and will impact current processes. Impact: Resistance, frustration and conflict over what changes should or should not be made. Probability: High Level: High

This is related to the above risk, but focus is on staff understanding how a LIMS application can truly benefit the organization and work, and their ability to incorporate that into planning. The risk is that there will be resistance to changing current processes, responsibilities or structure and attempting to force the LIMS to support current processes and work. 4/7/06

Risk Mitigation Strategy: Risk OC1

Again, creating plenty of opportunity for discussion and education about LIMS will make a difference. People are more likely to accept and take ownership of the changes in this environment if they are involved in the changes.



Organizational Change Management – risks relating to user involvement with and acceptance of the project.

IV&V Comments (1/2/06):

On December 19, 2006 the Project Steering Committee approved the following events to raise the awareness of SLD staff to the LIMS Project: SLD newsletter article for January 2007, brown bag lunch discussion in January 2007, and LIMS kick-off meeting in February 2007 once a vendor is selected and on board.

Risk Management – risks relating to appropriate and timely identification of project risks and mitigation planning.

Date Risk RM1 Risk Description Closure Inadequate risk management plan. Impact: Risks will not be closely managed, and mitigation will be reactive rather than proactive. Probability: Medium Level: Medium

Risk management plan does not provide tools or processes for 1) identifying risks and 2) specific steps, management and mitigation of those risks. (See discussion in text.)

4/7/06

Risk Mitigation Strategy: Risk RM1

Develop and regularly maintain a risk management strategy to clearly identify and rank risks, then a clear process by which these will be managed and reported on a regular basis. Submit for review.

6/6/06

Documentation Management – risks relating to adequate documentation for all project areas, including both project originating documentation and project managing documentation.

Date Risk D1 Risk Description Closure None at this time.



APPENDIX B

Project Steering Committee Minutes March thru May 2007

Steering Committee Meeting notes 03-14-

Steering Committee Meeting notes 04-11-

Steering Committee Meeting notes 5-22-0

New Mexico Department of Health – LIMS Project LIMS IV&V Sixth Periodic Review IM-4


APPENDIX C

LIMS Project OCIO Dashboard Reports (March thru May 2007)

LIMS Dashboard 2007-03-14.doc



New Mexico Department of Health – LIMS Project LIMS IV&V Sixth Periodic Review IM-4


APPENDIX D

LIMS Project Schedule March 13, 2007

The project schedule provided here reflects the revised dates and tasks once the RFP document/process was beginning to be finalized. The project has remained very close to schedule since the plan was updated.

LIMS.2007-03-14 proj plan.pdf

laboratory information management system (lims) project ... · 11/28/2007 · laboratory...

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