DATE - New Mexico Department of Information Technology

Change Request for Certification and Release of Funds Form

A L L C E R T I I F I I E D P R O J E C T S M U S T F O L L O W N M S T A T E P O L I I C I I E S A N D P R O C U R E M E N T C O D E

C H A N G E T Y P E : :

Scope Budget X Schedule X

P R O J E C T G O V E R N A N C E

P R O J E C T N A M E

P R O J E C T P H A S E

D A T E

L E A D A G E N C Y

O T H E R A G E N C I I E S

E X E C U T I I V E S P O N S O R

A G E N C Y H E A D

A G E N C Y C I I O / I I T L E A D

P R O J E C T M A N A G E R

Laboratory Information Management System (LIMS)

Implementation

9/22/2010

DOH

N/A

Dr. Dave Mills, State Laboratory Division Director

Dr. Alfredo Vigil, DOH Secretary

Sean Pearson, DOH Acting CIO

Tim Elsbrock

P R O J E C T A B S T R A C T ( ( P R O V I D E A B R I E F D E S C R I I P T I O N A N D P U R P O S E F O R T H I S P R O J E C T ) )

The New Mexico Department of Health’s Scientific Laboratory Division (SLD) receives more than 150,000 samples a year that result in over 700,000 unique test results. SLD was receiving increasing demands from its regulatory agencies, clients and key partners to modernize its information systems. Necessary functionality such as; required electronic reporting formats, privacy controls, electronic data exchange with clients and regulatory agencies (Centers for

Disease Control, Environmental Protection Agency), internal tracking of specimens, and the ability to collect and analyze required quality assurance data, were not in place. The ability to manage the entire SLD operation from one computer screen, in a holistic manner was impossible under the old IT infrastructure as it was a collection of more than 20 disparate databases that were based upon a section-specific ledger system. It was merely an electronic version of the paper-based recording system used by the laboratory more than 20 years ago.

Since the project was originally certified, the LIMS project has reviewed the COTS products currently on the market, performed extensive analysis of current and desired business processes, generated detailed system requirements, issued an RFP, and in October of 2008 started implementation.

The 20 month LIMS implementation to date has resulted in the installation and configuration

Revision: 9/1/10 Page 13


A L L C E R T I I F I I E D P R O J E C T S M U S T F O L L O W N M S T A T E P O L I I C I I E S A N D P R O C U R E M E N T C O D E of a barcode system and workflow tool whereby samples are traceable through the entire lab

(excluding the sections noted below). The system has increased database management capabilities by consolidating more than 20 disparate databases into one system. It has also increased security and data integrity through simplifying backup procedures and managing user access via role-based authentication as well as network level authentication.

Start Date 12/19/2005 Planned End Date 7/30/2011

J U S T I F I I C A T I I O N F O R C H A N G E I I N C E R T I I F I C A T I O N ( ( I I N C L U D E B U D G E T A D J U S T M E N T R E Q U E S T ; ; B U S I I N E S S V A L U E A N D / / O R

P R O G R A M R E S U L T S ) )

SLD is organized into four Bureaus: Sample Receiving, Biology, Toxicology/Implied Consent, and Chemistry. The LIMS project has been successfully rolled out across three of these four bureaus including: Sample Receiving, Biology, Toxicology and Implied Consent.

Additionally, the LIMS has been successfully implemented in half of the Chemistry Bureau.

The remaining half of the Chemistry Bureau consisting of the; Heavy Metals section, Water

Chemistry section, and Organic Chemistry section, has yet to be completed. These sections will be completed by adding a Phase 5. Adding this additional phase was required for the following reasons:



During the original contract negotiations and in an effort to reduce the overall cost of the system, the SLD removed some requirements that at time were thought to be satisfied by a workaround. Specifically, these requirements had to do with the use of spreadsheets used to perform extensive analytical and quality control-related calculations. As we moved through the lab with the LIMS implementation, and attained a grasp of how efficiencies can be gained through the use of such a unified system, it became apparent that we would need to integrate the functions performed by these spreadsheets into the LIMS.



To further complicate matters, the SLD move to the recently completed New Mexico

Scientific Laboratories Building was pending. To achieve the objectives of the project and still be able to fully utilize the available funding while the SLD moved to the new

180,000 square foot facility, half of the Chemistry section was removed from the Phase

4 scope of work and a LIMS upgrade to Version 6 was substituted. This upgrade was applied to all bureaus that went live in Phase 1, Phase 2, and Phase 3. Phase 4 was configured in LabWare LIMS Version 6 (all future configuration work will be in

Version 6).

The LIMS project has been successful in attaining the required funding for Phase 5. We have




$75,000 of support from Epidemiology and Response Division Lab Capacity grant, and have also received a $120,000 grant award from the Environmental Protection Agency. With this money the contract will be amended to reflect the Phase 5 deliverables that will enable the

SLD to complete the LIMS. Phase 5 implementation will start once the lab has completed the move into the new building. A move date has been set for September 16 th

. It is expected that the move will cause considerable disruption to lab operations for at least one month after this date. Phase 5 is currently slated to start in November.

Amount Requested this Certification

Amount Previously Certified

$ 195,000

$ 1,879,986

Remaining Appropriation not Certified

Total Appropriated Amount (include any new funds)

$

$ 2,074,986

C E R T I F I I C A T I I O N H I I S T O R Y ( I I N C L U D E A N Y P R E V I I O U S P R O J E C T O R P H A S E C E R T I I F I I C A T I O N S ) )

Date

Amount

12/19/2005

$155,000

7/21/2006 $845,000

Funding Source(s) (use specific citations to laws, grants, etc.)

$1,000,000 - Laws 2005, Chapter 33, Section 7, Subsection 23

12/14/2007 $879,986

$1,000,000 (extended from FY06) – Laws 2006, Chapter 109,

Section 7, Subsection 20

$ 554,000 Preparedness and Response to Bioterrorism Grant

(CDC Cooperative AgreementU90/CCU616999-05)

$ 217,436 Scientific Laboratory Division Operating Budget –

Laws 2007, Chapter 28, Section 4, Subsection F, DOH,

Paragraph 3

$108,550 – Preparedness and Response to Bioterrorism Grant

(CDC Cooperative Agreement U90/CCU616999-05)

A P P R O P R I A T I O N H I I S T O R Y

( ( I I N C L U D E A L L F U N D I I N G S O U R C E S , ,

E .

.

G .

.

F E D E R A L , , S T A T E , , C O U N T Y , ,

M U N I C I I P A L L A W S O R G R A N T S

) )

Fiscal Year

FY06

Amount

$1,000,000

Funding Source(s)

$1,000,000 - Laws 2005, Chapter 33, Section 7,




Subsection 23

FY07

$108,550

$108,550 – Preparedness and Response to Bioterrorism

Grant (CDC Cooperative Agreement U90/CCU616999-

05)

FY08

FY10

FY11

$446,436

$325,000

$195,000

$217,436 – Scientific Laboratory Division Operating

Budget – Laws 2007, Chapter 28, Section 4, Subsection

F, DOH, Paragraph 3

$229,000 Preparedness and Response to Bioterrorism

Grant (CDC Cooperative AgreementU90/CCU616999-

05)

$325,000 – Scientific Laboratory Division Operating

Budget – Laws 2007, Chapter 28, Section 4, Subsection

F, DOH, Paragraph 3

$120K from EPA Information Network Grant (EPA FY

2010 Exchange Network -OEI-10-01)

$75K from Lab Capacity Grant (CDC Cooperative

Agreement CDC- 5U50/CI623779)

M A J O R D E L I V E R A B L E S C H E D U L E A N D P E R F O R M A N C E M E A S U R E S

Major Project Deliverable and

Performance Measure

Budget Due Date Project Phase

Phase 5 requirements documentation and

Functional Gaps Specification (FGS).

$40,000 January

15 th

, 2011

Implementation

June 15th,

2011

Implementation Phase 5 pilot stage through User Acceptance

Testing (UAT) sign-off by bench level supervisors.

$70,000

Phase 5 Go-Live consists of two week parallel testing period and the configuration build being moved into production. Performance measure will be attaining 100% of samples being tracked by the LIMS with an audit trail archiving all changes made to all records.

$85,000 July 30 th ,

2011

Implementation




B U D G E T

Comments:

Staff -

Internal

Consulting

Services

Description FY07 & prior

PM Salary

Primary

Vendor and

IV&V

Hardware Consolidation

HW, Primary

Stack HW,

$45,000

$106,909

$74,580

FY08

$45,000

$72,600

$154,986

FY09

$90,000

$325,648

$109,088

FY10

$90,000

$642,400

$9,303

FY11

45,000

150,000

All

Peripherals across the lab

Software Middle ware and LabWare licensing

$18,256 $96,216

$226,489 $272,586 $542,992 $837,919 $195,000

T O T A L

I I N D E P E N D E N T V E R I I F I C A T I O N & V A L I D A T I I O N ( I I N C L U D E S U M M A R Y O F T H E L A T E S T I V & V R E P O R T ) )

Below is the summary from the most recent IV&V report dated July 8, 2010

This Independent Verification and Validation (IV&V) report for the LIMS project provides an update through Phase 4 of this daunting and very special project. The project has successfully made it through this phase in part due to the extended laboratory move schedule enabling the work to continue without interruption in the middle of script development and testing.

Chemistry was divided into two phases to accommodate the move and the fact that it is the largest lab section. Chemistry was originally to be one of the first phases but the width and breadth, including laboratory move, caused a change in the implementation schedule that ended up being a very sound decision. It was easier to ‘split’ this section for the move and have all of the experience from previous phases to alleviate problems in the more complex areas.




The LIMS system is functioning well and there is approximately 15% of the Chemistry area left in this final and most challenging phase of all. Factors include the complexity of the sections (or benches), instrumentation interfacing and a more challenging set of configuration criteria than has been previously encountered. The addition of Phase 5 to complete the last parts of Chemistry is fully funded and will be recertified via the Department of Information

Technology (DoIT) certification and release of funds process. This is a formality as the project has specific funding earmarked for the LIMS in the amounts of $75K (EPI) and $120K (EPA), for a total of $195K. This process is moving simultaneously as preparations get underway for the move scheduled in September, 2010. The final phase will begin in earnest as soon as setup is established in the new building.

All deliverables and deadlines for LabWare’s contract amendment dated March 2, 2010, were met and have completed the approval process for payment. The deliverables are discussed in detail in the next section. Meanwhile, tasks that can be done during the short hiatus will be done, but it is very important to note that the LIMS project team has not had a break in almost two years and it is recommended that some type of down time is encouraged for several of the team members who do not appear to have ever stopped. Acknowledgements to team members are provided herein by State Laboratory Division (SLD) management in the lessons learned section that was so eloquently stated.

Completion of Phases three and four were further exacerbated by the release of LIMS Version

6. All elements in every section previously implemented were checked for impact by the new software release. This was accomplished by rerunning every script and test for the LIMS system that were tested and approved on the previous version of the LIMS. There were some very minor ‘bugs’ such as the required rounding parameters for certain test results, but were remarkably minimal. This means that the LIMS up to Phase 4 has been thoroughly tested twice and it doesn’t get any better than that.

New Mexico Department of Health

LIMS Project

IV&V Closeout Report thru Phase 4

Bency & Associates 3 7/8/2010

Verification of Phases three and four were conducted section by section, bench by bench and based on personal interviews with the section leads responsible for each area, as well as technicians. Demonstrations were provided in some cases and all configuration and script information are maintained in each area as well as a master set electronically. All tests



A L L C E R T I I F I I E D P R O J E C T S M U S T F O L L O W N M S T A T E P O L I I C I I E S A N D P R O C U R E M E N T C O D E followed the same process for script development and logging of pass/fail criteria, with the exception of one bench where the template was not adequate for the type of testing and result output necessary, so they created their own. LabWare was consistent in making the proper changes virtually ‘on the fly’ as testing was conducted. Considering some of the previous section implementations, chemistry, to this point, has been referred to as ‘a breeze’. Chemistry had fewer types of testing, but alternatively, several were much more complex with numerous sub-processes involved.

This report will provide a summation of what should be considered a successful implementation to this point. The project has endured lowering of expectations but with the confidence they have planned and executed a fully functional and compliant system where several categories of enhancements will be added as time and funding permits in the future.

The following summation of relevant criteria for closeout at the end of Phase 4 is as follows:



Project Funding (FY10) – Funds appropriated $913K – expended $909,350 – Final

Balance $3,650



Project Funding (FY11) – Funds available $195K – Source – EPA - $120K; EPI -

$75K Current status is recertification for release of funds from DoIT.



Project Schedule – The project through Phase 4 completed exactly on time according to the schedule. All deliverables were provided by the deadlines. All areas are in production.



Deliverable Verification – All deliverables were approved, element by element.

Approval forms are kept on file in the Deputy Director’s office and maintained by

Twila Kunde.



Testing & Training – All sections were trained in the order of implementation. The training materials are tailored for each scientific discipline and have received positive results. The testing is based on the steps for individual configuration and the associated standard office procedure modifications that accommodate the new system and the associated scripts that were developed.



Implementation – Go-live for the project through Phase 4 was during the week prior to

June 30, 2010 and all project team members and management had good reason to celebrate! Implementation is a very involved process for all of the minute details required in each section.

The ability to concentrate without a major move in the middle of it was instrumental in this

Phase completion. It was an aggressive schedule and as will be divulged in the lessons learned



A L L C E R T I I F I I E D P R O J E C T S M U S T F O L L O W N M S T A T E P O L I I C I I E S A N D P R O C U R E M E N T C O D E section, it was stated that no matter how long you give a section for testing, they will go to the last day, so they made the timelines shorter and everyone stepped up to the challenge of thorough testing while trying to ‘break the system’ at the same time. It simply all went very well.

Conclusion:

This project continues to utilize best practices for executive management and planning, project management, risk management, requirements definition, business process analysis/reengineering, testing, training and implementation. Documentation for the final days leading up to this report was still being updated as the team has had way too much to complete, but the paperwork is catching up now for closeout to this Phase. The documentation retention practices surpassed expectations. The project team members are experienced, highly motivated task masters who are self-taught when necessary and helpful wherever and whenever the need arises. Scientists are an exacting group and it is refreshing to see the fierce ownership and pride they express and conduct in their work, though it is necessary with the LIMS to ‘let go’ a bit and let the system do what was done manually before. Remarkably, that has been a more difficult shift than setting up the system properly. A most pleasant dichotomy to observe.

Planning is never ending, the move is impending and the last complex areas will be addressed in the same knowledgeable, thoughtful and methodical way that has been successfully utilized to this point. The management team is busily preparing closeout documentation in order to recertify the project for the $195K that is available to complete Phase 5. Considering the positive nature and impact the new system already demonstrates, this process should be relatively easy. It has been a privilege to continue to be involved with this most incredible project.

Respectfully Submitted By:

Vinnie Gerecke, Sr. IV&V Specialist

Bency & Associates

July 8, 2010

I I M P A C T O F C H A N G E ( ( M A Y I I N C L U D E S I I G N I I F I I C A N T R I I S K S & M I I T I G A T I O N S T R A T E G Y ; ; S E C U R I I T Y , , C O N S O L I I D A T I O N & M A I N T E N A N C E

S T R A T E G I I E S ; ; R E C O R D S R E T E N T I I O N ; ; & B U S I N E S S P E R F O R M A N C E M E A S U R E S ) )

The major impact of this change is to complete the implementation of the LIMS throughout the entire chemistry bureau. This means that that the entire SLD will be implemented on the




LIMS.

The schedule risk to this phase is when SLD has completed their move to the new building.

This project will not kick off until that is completed as SLD staff will not be available until after the move is completed. The moved is expected to be completed in early October and

Phase 5 is expected to start in November.


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