TOXICOLOGY INSTRUMENTATION INTEGRATION WITH LIMS

PROJECT CHARTER

EXECUTIVE SPONSOR – TWILA R. KUNDE

BUSINESS OWNER – TWILA R. KUNDE

PROJECT MANAGER – ROSANNA DILL

ORIGINAL PLAN DATE: OCTOBER 24TH 2019

REVISION DATE: OCTOBER 24TH, 2019

VERSION: 1.0

TABLE OF CONTENTS1. PROJECT BACKGROUND.................................................................................................................................. 1

1.1 EXECUTIVE SUMMARY -RATIONALE FOR THE PROJECT 11.2 SUMMARY OF THE FOUNDATION PLANNING AND DOCUMENTATION FOR THE PROJECT 11.3 PROJECT CERTIFICATION REQUIREMENTS 1

2.0 JUSTIFICATION, OBJECTIVES AND IMPACTS....................................................................................................2

2.1 AGENCY JUSTIFICATION 22.2 BUSINESS OBJECTIVES 32.3 TECHNICAL OBJECTIVES 32.4 IMPACT ON ORGANIZATION 32.5 TRANSITION TO OPERATIONS4

3.0 PROJECT/PRODUCT SCOPE OF WORK............................................................................................................ 4

3.1 DELIVERABLES 43.1.1 Project Deliverables...................................................................................................................................43.1.2 Product Deliverables..................................................................................................................................5

3.2 SUCCESS AND QUALITY METRICS 5

4.0 SCHEDULE ESTIMATE..................................................................................................................................... 6

5.0 BUDGET ESTIMATE........................................................................................................................................ 7

5.1 FUNDING SOURCE(S) 75.2. BUDGET BY MAJOR DELIVERABLE OR TYPE OF EXPENSE - 75.3 BUDGET BY PROJECT PHASE OR CERTIFICATION PHASE 8

6.0 PROJECT AUTHORITY AND ORGANIZATIONAL STRUCTURE.............................................................................8

6.1 STAKEHOLDERS 86.2 PROJECT GOVERNANCE PLAN 96.3 PROJECT MANAGER9

6.3.1 PROJECT MANAGER CONTACT INFORMATION..........................................................................................96.3.2 PROJECT MANAGER BACKGROUND ..........................................................................................................9

6.4 PROJECT TEAM ROLES AND RESPONSIBILITIES 96.5 PROJECT MANAGEMENT METHODOLOGY 9

7.0 CONSTRAINTS............................................................................................................................................... 9

8.0 DEPENDENCIES............................................................................................................................................ 11

9.0 ASSUMPTIONS............................................................................................................................................ 11

10.0 SIGNIFICANT RISKS AND MITIGATION STRATEGY........................................................................................12

11.0 COMMUNICATION PLAN FOR EXECUTIVE REPORTING................................................................................12

i

12.0 INDEPENDENT VERIFICATION AND VALIDATION - IV&V..............................................................................12

13.0 PROJECT CHARTER AGENCY APPROVAL SIGNATURES.................................................................................15

14.0 PROJECT CHARTER CERTIFICATION APPROVAL SIGNATURE........................................................................15

Revision History

REVISION NUMBER DATE COMMENT

1.0 October 24 2019

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PROJECT CHARTER ALL PAYER CLAIMS DATABASE 1

1.0 PROJECT BACKGROUND

1.1 EXECUTIVE SUMMARY

The New Mexico Department of Health Scientific Laboratory Division (SLD) is the official public health, environmental and forensic toxicology laboratory for New Mexico. SLD’s key objectives are to provide quality analytical services in infectious diseases, environmental monitoring and forensic toxicology to public programs serving the citizens of New Mexico.

The SLD uses an integrated Laboratory Information Management System (LIMS) that tracks samples as they come to the SLD, compiles quality controls, audit trails, and ultimately, generates the final report which can either be mailed or sent electronically via email.

The SLD’s Toxicology bureau does New Mexico’s impaired driving samples for drug impairment, cause of death samples from the Office of Medical Investigator, chemical testing of blood and/or urine of the alleged victims of sexual assault and drug tests and drug screenings. The Bureau has 15 instruments for the testing. Currently, test batches are manually entered into the instruments, and results are manually entered into the LIMS to generate the final report.

This Project will integrate 14 Toxicology Bureau instruments into the LIMS to automate test batches and result entry, improving efficiency, reducing turn-around times, reducing data entry errors, and streamlining reports.

1.2 SUMMARY OF THE FOUNDATION PLANNING AND DOCUMENTATION FOR THE PROJECT

A preliminary scope of work and timeline including testing, promotion to production and go live support has been developed in collaboration with the existing LIMS vendor. Documentation for the instruments has been gathered. The procurement method for the vendor is established

1.3 PROJECT CERTIFICATION REQUIREMENTS

CRITERIA YES/NO EXPLANATION

Project is mission critical to the agency Yes This will help the SLD be more efficient, freeing up resources to be expert witnesses, allowing more testing to be done locally and

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PROJECT CHARTER ALL PAYER CLAIMS DATABASE 2

improving turnaround time

Project cost is equal to or in excess of $100,000.00

Yes

Project impacts customer on-line access No

Project is one deemed appropriate by the Secretary of the DoIT

Yes

Will an IT Architecture Review be required? No Instruments are being integrated with an existing LIMS system via files. Few infrastructure changes are anticipated.

2.0 JUSTIFICATION, OBJECTIVES AND IMPACTS

2.1 AGENCY JUSTIFICATION

NUMBER DESCRIPTION

DOH 1 Instrument integration will enable SLD to meet legal deadlines for testing

DOH 2 Instrument integration will reduce test errors due to transcription issues, improve test turnaround time

DOH 3 Instrument integration will enable SLD to provide better support for law enforcement with timely results and by freeing up analysts to be SME’s in court

DOH 4 Instrument integration will enable SLD to process Cause of Death Samples inhouse

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2.2 BUSINESS OBJECTIVES

NUMBER DESCRIPTION

BUSINESS OBJECTIVE 1

Accelerate the turnaround time for chemical analysis and toxicological reporting 

BUSINESS OBJECTIVE 2

Improve lab testing capacity

BUSINESS OBJECTIVE 3

Free Analyst to support law enforcement in court and elsewhere

BUSINESS OBJECTIVE 4

Reduce the need for Cause of Death outsourcing

2.3 TECHNICAL OBJECTIVES

NUMBER DESCRIPTION

TECHNICAL OBJECTIVE 1

Successfully import test batches from LIMS to Instruments

TECHNICAL OBJECTIVE 2

Reduce clerical errors.

TECHNICAL OBJECTIVE 3

Successfully import test results from instruments into LIMS

TECHNICAL OBJECTIVE 4

Streamline testing processes

2.4 IMPACT ON ORGANIZATION

AREA DESCRIPTION

END USERS Lab Analysts will need to learn how to send batches to instruments and send results to the LIMS, adapting to the new processes

BUSINESS SLD may change business processes to provide additional testing

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AREA DESCRIPTION

PROCESSES based on increased capacity

IT OPERATIONS AND STAFFING

The Instrument Integration project may need additional staff temporarily during the project while key staff are testing and learning

OTHER

2.5 TRANSITION TO OPERATIONS

AREA DESCRIPTION

PRELIMINARY OPERATIONS LOCATION AND STAFFING PLANS

The Toxicology Instrumentation Integration with LIMS project once operational, should enable analysts to perform other work based on efficiencies gained

DATA SECURITY, BUSINESS CONTINUITY

The Toxicology Instrumentation Integration with LIMS will work via file parsing/transfer between the LIMS and the instruments. Protocols for ensuring the files transfer securely and be replicated against loss may be needed

MAINTENANCE STRATEGY

The LIMS will continue to be maintained by the existing vendor.

INTEROPERABILITY Project may foster the integration of additional instruments in other parts of SLD with the LIMS

RECORD RETENTION The Toxicology Instrumentation Integration with LIMS project will comply with applicable state and federal standards for data retention

CONSOLIDATION STRATEGY

The Toxicology Instrumentation Integration with LIMS project is not a consolidation, but rather the elimination of manual work

3.0 PROJECT/PRODUCT SCOPE OF WORK

3.1 DELIVERABLES

3.1.1 PROJECT DELIVERABLES

PCC Certification Forms

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Project Plan and Schedule Project Closeout Report Sole Source Filing and Contract for LIMS Vendor IV&V and TARC waiver request submissions IV&V Reports (if required)- Initiation Phase IV&V Contract (if required)

3.1.2 PRODUCT DELIVERABLES

Technical/Architectural Documentation

Test plans

Disaster recovery plan

Change management plan-including external (customer) communications

Deployment Plans

Training

Tox 1 - Two instruments interfaced in DEV: Ethyl, Fred

Tox 2 - Ten instruments interfaced in DEV: Kiska, Usha, Shush Yazhi, Ixtab, Princess, Maryjane, Morpheus, Stephanie, Baba, Kairi

Tox 3 - One instrument (1) interfaced in DEV: Astraea

Tox 4 - One instrument (1) interfaced in DEV: Obitrap

Tox 5 - Promotion of configuration for instrument interfacing to TEST

Tox 6 - Background scheduler set up for automatic processing of instrument files in TEST

Tox 7 - Promotion of configuration for instruments to Production

Tox 8 - Five days post move to Production

3.2 SUCCESS AND QUALITY METRICS

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NUMBER DESCRIPTION

QUALITY METRIC 1 Percentage reduction in processing times 

QUALITY METRIC 2 Percentage reduction in clerical errors

QUALITY METRIC 3 Percentage reduction in turn-around time for reporting 

UALITY METRIC 4 Percentage increase in cause of death tests

QUALITY METRIC 5 Percentage increase in meeting deadlines for testing

QUALITY METRIC 6 Percentage increase in law enforcement requests completed

4.0 PRELIMINARY SCHEDULE ESTIMATE

Initiation phase – Oct 2019- Dec 2019

Planning phase – Jan 2020 – Feb 2020

Implementation- March 2020 – Oct 2020

Closeout – Oct 2020 – Nov 2020

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5.0 BUDGET ESTIMATE

5.1 FUNDING SOURCE(S)

SOURCE AMOUNT ASSOCIATED RESTRICTIONS

Laws of 2019, Chapter 271 Section 7 (26) $440,000 NA

5.2. BUDGET BY MAJOR DELIVERABLE OR TYPE OF EXPENSE

ITEM COST ESTIMATE

LIMS VENDOR FOR INTEGRATION WORK

$190,000

HARDWARE TBD

SOFTWARE TBD

IV&V INITIAL ASSESSMENT (IF REQUIRED)

$6,000

REMAINING IV&V (IF REQUIRED) $36,000

TOTAL $232,000

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5.3 BUDGET BY PROJECT PHASE OR CERTIFICATION PHASE

PHASE COST ESTIMATE

INITIATION $196,000

PLANNING $15,000

IMPLEMENTATION $15,000

CLOSEOUT $6,000

TOTAL $232,000

6.0 PROJECT AUTHORITY AND ORGANIZATIONAL STRUCTURE

6.1 STAKEHOLDERS

NAME STAKE IN PROJECT ORGANIZATION TITLE

TWILA KUNDE Provide Strategic Direction, and Steering within DOH

DOH/SLD ACTING DIRECTOR

LAB ANALYSTS

End users of LIMS and the instruments, people who set up and run the tests

DOH/SLD VARIES

SARA LUCERO LIMS Manager, DOH/ITSD APP DEV

LAW ENFORCEMENT Test requesters MULTIPLE VARIES

OFFICE OF MEDICAL INVESTIGATOR

Test requestersMULTIPLE VARIES

PUBLIC- Crime victims, Others MULTIPLE VARIES

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NAME STAKE IN PROJECT ORGANIZATION TITLE

affected by test results

6.2 PROJECT GOVERNANCE PLAN

TBD

6.3 PROJECT MANAGER

6.3.1 PROJECT MANAGER CONTACT INFORMATION

NAME ORGANIZATION PHONE #(S) EMAIL

ROSANNA DILL DOH ITSD PMO 699-1582 ROSANNA.DILL2@STATE.NM.US

PM HIRE DOH ITSD PMO TBD TBD

6.3.2 PROJECT MANAGER BACKGROUND

Rosanna Dill has been an IT project manager for about five years, receiving her Project Management Professional (PMP)® certification in 2013. She worked for HP and Applied Biosystems as a project manager. Before becoming a project manager for healthcare clients, she did high-end server hardware support, as well as software support, installation, and training as part of a professional services consulting team for a laboratory information management system. Ms. Dill also worked in architecture and construction and has a BA in architecture from Rice University. She began working for the State of New Mexico’s Department of Information Technology’s Enterprise Project Management Office in 2016 and currently works for the state of New Mexico as an IT project manager with the Department of Health's PMO

6.4 PROJECT TEAM ROLES AND RESPONSIBILITIES

TBD. The project team expects to be able to escalate issues through the steering committee to the executive sponsor if needed.

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PROJECT CHARTER ALL PAYER CLAIMS DATABASE 10

6.5 PROJECT MANAGEMENT METHODOLOGY

The plan for The Toxicology Instrumentation Integration with LIMS project is it will be a primarily waterfall project, perhaps with some iterative portions of execution for the integration of groups of instruments.

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7.0 CONSTRAINTS

NUMBER DESCRIPTION

1 Analyst availability for participation. Toxicology analysts will be needed for planning and testing. They are already not able to meet demand for their expertise.

2 Availability of samples for testing

3 Availability of key expertise from vendor.

8.0 DEPENDENCIES

Mandatory dependencies are dependencies that are inherent to the work being done. D- Discretionary dependencies are dependencies defined by the project management team. This may also

encompass particular approaches because a specific sequence of activities is preferred, but not mandatory in the project life cycle.

E-External dependencies are dependencies that involve a relationship between project activities and non-project activities such as purchasing/procurement

NUMBER DESCRIPTION TYPE M, D, E

1 LIMS: Must be functioning properly M

2 Project: Project needs initiation certification to be able to fund contracts

E

3 Instruments: Must also be working properly M

9.0 ASSUMPTIONS

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PROJECT CHARTER ALL PAYER CLAIMS DATABASE 12

NUMBER DESCRIPTION

1 Vendor quote does not drastically change in next few months.

2 Instruments can be integrated as is.

10.0 SIGNIFICANT RISKS AND MITIGATION STRATEGY

Additional risks will be identified as the project progresses.

Risk 1

Challenges due to the age of the instruments. SLD does not have the budget available to update all the instruments

Probability: High Impact MEDIUM

Mitigation Strategy: Work closely with the vendor during the requirements gathering phase to ensure the correct parsing scripts are developedContingency Plan: Find additional budget to upgrade or leave instrument in “manual mode”

Risk 2

Delays in change testing because of real-world demands on staff time (sample load/court responsibilities/staff availability

Probability: High Impact HIGH

Mitigation Strategy: Work with the vendor to have a reasonable schedule and have the ‘ideal’ target date but have time to a ‘real’ target date.Contingency Plan: Add contract Staff Augmentation analysts if possible

Risk 3

Continual updates in drugs of choice requires testing flexibility.

Probability: High Impact MEDIUM

Mitigation Strategy: Work with the vendor to develop parsing scripts that can be easily modified to adjust for new drugs of choiceContingency Plan: Contract with vendor to help provide scripts as new drugs show up.

11.0 COMMUNICATION PLAN FOR EXECUTIVE REPORTING

Good, clear, timely communication is key to any project’s success. The project team, including the vendor will meet with each other on a regular basis to coordinate and track progress as well as address issues. The project manager will also report in person to the steering committee prior

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to key milestone events in addition to providing regular email status reports. Any urgent issue requiring support/advice/attention from the executive team will be reported as soon as possible by the PM, based on observation by phone or in person.

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12.0 INDEPENDENT VERIFICATION AND VALIDATION - IV&V

The work of the project is well defined, involving changes to an existing system. Hardware infrastructure changes are not anticipated. We therefore plan to request both TARC and IV&V waivers as we believe the negative risks to successful outcome are low.

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13.0 PROJECT CHARTER AGENCY APPROVAL SIGNATURES

SIGNATURE DATE

EXECUTIVE SPONSOR

BUSINESS OWNER

PROJECT MANAGER

14.0 PROJECT CHARTER CERTIFICATION APPROVAL SIGNATURE

SIGNATURE DATE

DOIT / PCC APPROVAL

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