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TOXICOLOGY INSTRUMENTATION INTEGRATION WITH LIMS

PROJECT MANAGEMENT PLAN (PMP)

EXECUTIVE SPONSOR – TWILA R. KUNDE

BUSINESS OWNER - TWILA R. KUNDE

PROJECT MANAGER – ROSANNA DILL

ORIGINAL PLAN DATE: JANUARY 23RD, 2020REVISION DATE: JANUARY 23RD, 2020

REVISION: 1

PROJECT MANAGEMENT PLAN FOR TOXICOLOGY INSTRUMENT INTEGRATION WITH LIMS

REVISION HISTORY............................................................................................................................................. III

PREPARING THE PROJECT MANAGEMENT PLAN................................................................................................. IV

ABOUT THIS DOCUMENT................................................................................................................................... IV

PROJECT OVERSIGHT PROCESS MEMORANDUM – DOIT, JULY 2007.................................................................................... IV

1.0 PROJECT OVERVIEW...................................................................................................................................... 1

1.1 EXECUTIVE SUMMARY- RATIONALE FOR THE PROJECT....................................................................................................11.2 FUNDING AND SOURCES...........................................................................................................................................11.3 CONSTRAINTS........................................................................................................................................................11.4 DEPENDENCIES.......................................................................................................................................................21.5 ASSUMPTIONS...................................................................................................................................................21.6 INITIAL PROJECT RISKS IDENTIFIED...........................................................................................................................2

2.0 PROJECT AUTHORITY AND ORGANIZATIONAL STRUCTURE.............................................................................3

2.1 STAKEHOLDERS......................................................................................................................................................32.2 PROJECT GOVERNANCE STRUCTURE...........................................................................................................................4

2.2.1 Describe the organizational structure – Org Chart....................................................................................42.2.2 Describe the role and members of the project steering committee...........................................................42.2.3 Organizational Boundaries, interfaces and responsibilities.......................................................................4

2.3 EXECUTIVE REPORTING............................................................................................................................................4

3.0 SCOPE........................................................................................................................................................... 4

3.1 PROJECT OBJECTIVES..............................................................................................................................................43.1.1 Business Objectives...................................................................................................................................43.1.2 Technical Objectives..................................................................................................................................5

3.2 PROJECT EXCLUSIONS..............................................................................................................................................53.3 CRITICAL SUCCESS FACTORS.....................................................................................................................................5

4.0 PROJECT DELIVERABLES AND METHODOLOGY...............................................................................................6

4.1 PROJECT MANAGEMENT LIFE CYCLE..........................................................................................................................64.1.1 Project Management Deliverables............................................................................................................64.1.2 Deliverable Approval Authority Designations............................................................................................64.1.3 Deliverable Acceptance Procedure............................................................................................................7

4.2 PRODUCT LIFE CYCLE.........................................................................................................................................74.2.1 Technical Strategy.....................................................................................................................................84.2.2 Product and Product Development Deliverables.......................................................................................84.2.3 Deliverable Approval Authority Designations..........................................................................................134.2.4 Deliverable Acceptance Procedure..........................................................................................................14

5.0 PROJECT WORK........................................................................................................................................... 14

5.1 WORK BREAKDOWN STRUCTURE (WBS)..................................................................................................................145.2 SCHEDULE ALLOCATION -PROJECT TIMELINE..............................................................................................................145.3 PROJECT BUDGET.................................................................................................................................................145.4 PROJECT TEAM....................................................................................................................................................15

5.4.1 Project Team Organizational Structure...................................................................................................155.4.2 Project Team Roles and Responsibilities..................................................................................................15

5.5 STAFF PLANNING AND RESOURCE ACQUISITION................................................................................................165.5.1 Project Staff.............................................................................................................................................165.5.2 Non-Personnel resources.........................................................................................................................17

5.6 PROJECT LOGISTICS.........................................................................................................................................175.6.1 Project Team Training.............................................................................................................................17

REVISION: 1.0 i OF vi


6.0 PROJECT MANAGEMENT AND CONTROLS....................................................................................................17

6.1 RISK AND ISSUE MANAGEMENT..............................................................................................................................176.1.1 Risk Management Strategy.....................................................................................................................176.1.2 Project Risk Identification........................................................................................................................176.1.3 Project Risk Mitigation Approach............................................................................................................186.1.4 Risk Reporting and Escalation Strategy...................................................................................................186.1.5 Project Risk Tracking Approach...............................................................................................................186.1.6 ISSUE MANAGEMENT..............................................................................................................................18

6.2 INDEPENDENT VERIFICATION AND VALIDATION - IV&V...........................................................................................186.3 SCOPE MANAGEMENT PLAN..................................................................................................................................18

6.3.1 Change Control........................................................................................................................................186.4 PROJECT BUDGET MANAGEMENT............................................................................................................................19

6.4.1 Budget Tracking......................................................................................................................................196.5 COMMUNICATION PLAN........................................................................................................................................19

6.5.1 Communication Matrix............................................................................................................................196.5.2 Status Meetings.......................................................................................................................................196.5.3 Project Status Reports.............................................................................................................................19

6.6 PERFORMANCE MEASUREMENT (PROJECT METRICS).....................................................................................196.6.1 Baselines.................................................................................................................................................19

6.7 QUALITY OBJECTIVES AND CONTROL..............................................................................................................196.7.1 quality Standards....................................................................................................................................206.7.2 Project and Product Review AND ASSESSMENTS.....................................................................................206.7.3 Agency/Customer Satisfaction................................................................................................................206.7.4 PRODUCT DELIVERABLE ACCEPTANCE PROCESS......................................................................................20

6.8 CONFIGURATION MANAGEMENT...................................................................................................................206.8.1 Version Control........................................................................................................................................206.8.2 Project Repository (Project Library).........................................................................................................20

6.9 PROCUREMENT MANAGEMENT PLAN............................................................................................................20

7. 0 PROJECT CLOSE........................................................................................................................................... 20

7.1 Administrative Close...................................................................................................................................207.1.1 Close activities for phases and the project...............................................................................................217.1.2 Additional activities for project close......................................................................................................217.2 Contract Close............................................................................................................................................21

ATTACHMENTS................................................................................................................................................. 21

REVISION: 1.0 ii OF vi


REVISION HISTORY

REVISION NUMBER DATE COMMENT

1.0 January 23rd 2020 DOH 1st draft for planning purposes

2.0

2.1

2.2

REVISION: 1.0 iii OF vi


PREPARING THE PROJECT MANAGEMENT PLAN

The workbook for preparation of the Project Management Plan is built around helping the project manager and the project team to use the Project Management Plan in support of successful projects. Please refer to it while developing this PMP for your project.

REVISION: 1.0 iv OF vi


1.0 PROJECT OVERVIEW

1.1 EXECUTIVE SUMMARY- RATIONALE FOR THE PROJECT 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 FUNDING AND SOURCES

SOURCE AMOUNT ASSOCIATED RESTRICTIONS

APPROVERS

Laws of 2019, Chapter 271 Section 7 (26)

$440,000 NA PCC Committee, Lab Director or designee

1.3 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.

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1.4 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

1.5 ASSUMPTIONS

NUMBER DESCRIPTION

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

2 Instruments can be integrated as is.

1.6 INITIAL PROJECT RISKS IDENTIFIEDRisk 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

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.

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responsibilities/staff availability

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.

2.0 PROJECT AUTHORITY AND ORGANIZATIONAL STRUCTURE

2.1 STAKEHOLDERS

NAME STAKE IN PROJECT ORGANIZATION TITLE

TWILA KUNDE Provide Strategic Direction, and Steering within DOH

DOH/SLD DEPUTY DIRECTOR

LAB ANALYSTS

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

DOH/SLD VARIES

SAM KLEINMAN Bureau chief responsible for managing the analysts

DOH/SLDTOXICOLOGY BUREAU CHIEF

SARA LUCERO LIMS Manager, DOH/ITSD APP DEV

ELIZABETH VELASQUEZ

Manager for DoH facilities software

DOH/ITSD APP DEV MGR

LAW ENFORCEMENT Test requesters MULTIPLE VARIES

OFFICE OF MEDICAL INVESTIGATOR Test requesters MULTIPLE VARIES

PUBLIC- Crime victims, Others affected by test results

MULTIPLE VARIES

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2.2 PROJECT GOVERNANCE STRUCTURE2.2.1 DESCRIBE THE ORGANIZATIONAL STRUCTURE – ORG CHART

2.2.2 DESCRIBE THE ROLE AND MEMBERS OF THE PROJECT STEERING COMMITTEE

A steering committee consisting of SLD and ITSD leadership will provide oversight and guidance to the project in addition to the oversight provided by DoIT. The project manager will report to the committee on a regular basis

2.2.3 ORGANIZATIONAL BOUNDARIES, INTERFACES AND RESPONSIBILITIES.

The project manager will provide overall coordination and management to the project team which will consist of SLD, ITSD and a vendor representative. The vendor will be responsible for coordination within their own staff.

Communication with external stakeholders will be coordinated by the project manager and delivered through existing SLD channels.

2.3 EXECUTIVE REPORTINGGood, 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 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.

3.0 SCOPE

3.1 PROJECT OBJECTIVES3.1.1 BUSINESS OBJECTIVES

NUMBER DESCRIPTION

BUSINESS OBJECTIVE 1

Accelerate the turnaround time for chemical analysis and toxicological reporting


Improve lab testing capacity


Free Analyst to support law enforcement in court and elsewhere


Reduce the need for Cause of Death outsourcing

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3.1.2 TECHNICAL OBJECTIVES

NUMBER DESCRIPTION

TECHNICAL OBJECTIVE 1

Successfully import test batches from LIMS to Instruments


Reduce clerical errors.


Successfully import test results from instruments into LIMS


Streamline testing processes

3.2 PROJECT EXCLUSIONS

3.3 CRITICAL SUCCESS FACTORS

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

QUALITY 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

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4.0 PROJECT DELIVERABLES AND METHODOLOGY

4.1 PROJECT MANAGEMENT LIFE CYCLE

Phase Key Deliverables

Initiation PCC initiation docs, Project Charter, Waiver requests

Planning Project management plan, & related plan documents. Finalized RACI, task plan/Work Breakdown Structure (WBS

Execution Product deliverables from contractor and others, test results

Monitoring and controlling Status reports, Risk and issues logs, change requests

Closeout Acceptance docs, lessons learned

4.1.1 PROJECT MANAGEMENT DELIVERABLES

4.1.1.1 [Deliverable 1 Name]Description - Deliverable Acceptance Criteria

Standards for Content and Format -

Quality Review -.

4.1.1.2 [Deliverable 2 Name]

Description - Deliverable Acceptance Criteria -

Standards for Content and Format -

Quality Review -

4.1.2 DELIVERABLE APPROVAL AUTHORITY DESIGNATIONS

.

DELIVERABLE NUMBER

DELIVERABLE APPROVERS (WHO CAN APPROVE)

DATE APPROVED

PRJ-DEL-001 Draft Project Charter DoIT EPMO, business owner

Oct 24 2019

PRJ-DEL-002 PCC initiation presentation DoIT EPMO, business owner

Oct 24 2019

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DELIVERABLE NUMBER


DATE APPROVED

PRJ-DEL-003 PCC initiation request DoIT EPMO, business owner

Oct 24 2019

PRJ-DEL-004 Finalized Project Charter DoIT EPMO, business owner

Jan 23 2020

PRJ-DEL-005 PCC Planning presentation DoIT EPMO, business owner

Jan 23 2020

PRJ-DEL-006 PCC Planning request DoIT EPMO, business owner

Jan 23 2020

PRJ-DEL-007 Draft PMP DoIT EPMO, business owner

Jan 23 2020

PRJ-DEL-008 Waiver requests DoIT EPMO, business owner, CIO

Jan 9 2020

PRJ-DEL-009 Vendor contract Vendor, DOH, DoIT TBD

PRJ-DEL-0010 Updated PMP

4.1.3 DELIVERABLE ACCEPTANCE PROCEDURE

Project deliverables will be reviewed and accepted by the business owner after review by the team and the PMO. Additional approvals from the Project certification committee where applicable.

4.2 PRODUCT LIFE CYCLE

Phase Key Deliverables

Initiation Draft Sole Source determination,

Planning Final Sole Source determination submitted to SPD, LIMS Vendor Contract, Other procurements as needed

Execution Product deliverables from contractor and others, test plans, test results, training docs

Monitoring and controlling Test reports, vendor status reports

Closeout transition to operations plan, operations documenation

PAGE | 7

BERNADETTE JARAMILLO, 01/15/20, RESOLVED

You may want to include the current date for updating this document

Rosanna Dill, 01/16/20,

Updated PMP will be supplied at Implementation Certification request


4.2.1 TECHNICAL STRATEGY

Once the vendor contract is executed, the Project team will finalize a task plan with schedule agreed to by SLD staff, program management, ITSD and the vendor. Design and development for 4 instrument groups may happen iteratively for each group, culminating in a demonstration of the integration in development environment. Once the demonstrations are successful, all instrument configurations will be promoted to a test environment for User Acceptance Testing and subsequent promotion to Production once issues are resolved.

4.2.2 PRODUCT AND PRODUCT DEVELOPMENT DELIVERABLES

Product Deliverables are work products or artifacts that are driven by the product management methodology requirements and standard project management practices regardless of the product requirements of the project.

4.2.2.1 Interface 2 GC FID Instruments to the LIMS DEV

Interface 2 GC FID Instruments to the LIMS DEV

Due Date:49 Days after Project

KickoffCompensation:

$23,000.00 including GRT.

Task Item Sub Tasks Description

1. GC-FID interface

requirements and design

1.1 The Contractor shall perform Requirements gathering and documentation for integration of 2 Agilent Headspace Gas Chromatographs with Flame Ionization Detectors in to the existing SLD LIMS.

1.2 Contractor shall perform configuration of the LIMS system for analysis related to the 2 GC FID instruments

1.3 Contractor shall provide LIMS instrument configuration for the instruments including the RSF file and results in parsing.

1.4 Contractor shall provide installation documentation and a software package for deployment to TEST environment.

1.5 Contractor shall provide RSF files for the two (2) instruments to the SLD for testing in DEV environment.

1.6 Contractor shall demonstrate the parsing of instrument files for the two (2) instruments in DEV environment.

1.7 Contractor shall adjust the LIMS analysis configuration and or the LIMS instrument configuration/RSF file based on SLD Lab feedback from the demonstration. Contractor shall update the requirements and other documentation to reflect design changes as applicable.

2. SLD 2.1 Contractor shall provide the RSF files and other documentation for the

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Approval GC-FID instrument interface design to the SLD/Procuring Agency for review and approval

4.2.2.2 10 Gas Chromatography/ Mass Spectrometry (GCMS) instruments interfaced in DEV: Kiska, Usha, Shush Yazhi, Ixtab, Princess, Maryjane, Morpheus, Stephanie, Baba, Kairi

Interface 10 GCMS Instruments to the LIMS DEV





1. GCMS interface


1.1 The Contractor shall perform Requirements gathering and documentation for integration of 10 Agilent Gas Chromatography/Mass Spectrometry instruments in to the existing SLD LIMS.

1.2 Contractor shall perform configuration of the LIMS system for analysis related to the 10 GC/MS instruments



1.5 Contractor shall provide RSF files for each of the ten (10) instruments to the SLD for testing in DEV environment.

1.6 Contractor shall demonstrate the parsing of instrument files for the ten (10) instruments in DEV environment.


2. SLD Approval

2.1 Contractor shall provide the RSF files and other documentation for the GC/MS instrument interface design to the SLD/Procuring Agency for review and approval

4.2.2.3 Liquid Chromatography/ Mass Spectrometry (LCMS) instrument interfaced in DEV: Astraea

Interface LCMS Instrument Astraea to the LIMS DEV


Compensation:$12,000.00 including GRT.

PAGE | 9


Kickoff


1. LCMS interface


1.1 The Contractor shall perform Requirements gathering and documentation for integration of Agilent Liquid Chromatography/Mass Spectrometry instrument Astraea in to the existing SLD LIMS.

1.2 Contractor shall perform configuration of the LIMS system for analysis related to the LCMS instrument.



1.5 Contractor shall provide RSF files for the LCMS instrument to the SLD for testing in DEV environment.

1.6 Contractor shall demonstrate the parsing of instrument files for the LCMS instrument Astraea in DEV environment.


2. SLD Approval

2.1 Contractor shall provide the RSF files and other documentation for the LC/MS instrument interface design to the SLD/Procuring Agency for review and approval

4.2.2.4 One Q Exactive™ Mass Spectrometry instrument interfaced in DEV: Obitrap

Interface LCMS Instrument Astraea to the LIMS DEV





1. Q Exactive Mass

Spectrometry interface

1.1 The Contractor shall perform Requirements gathering and documentation for integration of the Q Exactive™ Mass Spectrometry instrument Obitrap in to the existing SLD LIMS.

1.2 Contractor shall perform configuration of the LIMS system for analysis

PAGE | 10



related to the Q Exactive™ Mass Spectrometry instrument.,

1.3 Contractor shall provide LIMS instrument configuration for the instrument including the RSF file and results in parsing.


1.5 Contractor shall provide RSF files for the Q Exactive™ Mass Spectrometry instrument to the SLD for testing in DEV environment.

1.6 Contractor shall demonstrate the parsing of instrument files for the Q Exactive™ Mass Spectrometry instrument Obitrap in DEV environment.


2. SLD Approval

2.1 Contractor shall provide the RSF files and other documentation for the Q Exactive™ Mass Spectrometry instrument interface design to the SLD/Procuring Agency for review and approval

4.2.2.5 Promotion of configuration of Instrument Interfaces to TEST environment

Promotion of configuration of Instrument Interfaces to TEST

environment





1. Promotion of

configuration of Instrument Interfaces to

TEST environment

1.1 The Contractor shall collaborate with SLD staff to develop, document and plan user acceptance testing (UAT).

1.2 Contractor shall promote approved instrument interfaces to TEST environment, after first collaborating with SLD to gain approval for the promotion from the DOH ITSD Change Management Review Board.

1.3 Contractor shall provide support to SLD staff during UAT.

1.4 Contractor shall track all issues found in testing in a numbered format.

1.5 Contractor shall resolve issues found during UAT, documenting the resolution in the issue tracking system.

1.6 Contractor shall provide RSF files for the 14 instruments to SLD for

PAGE | 11


testing in TEST environment.

1.7 Contractor shall Demonstrate parsing of files for the 14 instruments to SLD in TEST environment.

1.8 Contractor shall adjust RSF files based on SLD Lab feedback from the demonstration.

2. Training2.1 Contractor shall provide training and training documentation to SLD

staff on the instrument integration based on template samples.

3. SLD Approval

3.1 Contractor shall provide UAT test results and training documentation to SLD/Procuring Agency for review and approval

4.2.2.6 Automatic Processing of Instrument Files

Automatic Processing of Instrument Files





1. Automatic Processing of

Instrument Files

1.1 The Contractor shall setup background scheduled process for automatic processing of instrument files, documenting the setup.

1.2 Contractor shall demo the scheduled process for automation of file processing for the 14 instruments and resolve any issues with the background scheduling process, documenting them in the issue tracking system.

1.3 Contractor shall create a package for deployment to PROD environment. Contractor shall develop and provide installation documentation for the package to the SLD.

2. SLD Approval

2.1 Contractor shall provide all documentation, artifacts associated with this deliverable to SLD/Procuring Agency for review and approval.

4.2.2.7 Promotion to Production

Promotion to Production





1. Promotion to Production

1.1 The Contractor shall provide the configuration package to NM for promotion to Production

PAGE | 12


1.2 Contractor shall provide installation documentation to NM for promotion to Production

1.3 Contractor shall promote the instrument interfaces to production after first collaborating with SLD to gain approval for the promotion from the DOH ITSD Change Management Review Board.

2. SLD Approval


4.2.2.8 Post Go Live support

Post Go-Live Support

Due Date:168

Days after Project Kickoff

Compensation:$7,200.00 including GRT.


1. Post go Live Support

1.1 The Contractor shall support the SLD post GO-LIVE for 5 days, documenting and resolving any issues arising with the instrument integration in Production environment.

2. SLD Approval


4.2.3 DELIVERABLE APPROVAL AUTHORITY DESIGNATIONS

Complete the following table to identify the deliverables this project is to produce, and to name the person or persons who have authority to approve each deliverable.

DELIVERABLE NUMBER


DATE APPROVED

1 Two GC-FID instruments interfaced in DEV: Ethyl, Fred

Twila/Sam

2 10 Gas Chromatography/ Mass Spectrometry (GCMS) instruments interfaced in DEV: Kiska, Usha,

Twila/Sam

PAGE | 13


DELIVERABLE NUMBER


DATE APPROVED

Shush Yazhi, Ixtab, Princess, Maryjane, Morpheus, Stephanie, Baba, Kairi

3 Liquid Chromatography/ Mass Spectrometry (LCMS) instrument interfaced in Dev: Astrea

Twila/Sam

4 One Q Exactive™ Mass Spectrometry instrument interfaced in DEV: Obitrap

Twila/Sam

5 Promotion of configuration of Instrument Interfaces to TEST environment

Twila/Sam

6 Automatic Processing of Instrument Files

Twila/Sam

7 Promotion to Production Twila/Sam

8 Post Go Live support Twila/Sam

4.2.4 DELIVERABLE ACCEPTANCE PROCEDURE

The Vendor will submit documentation for the deliverable and a request for approval to the Project manager. The PM and the team will review the completed work for completion, quality and suitability and make an approval recommendation to the business owner. Business owner will approve or return for additional work. On approval, vendor can submit an invoice for payment

5.0 PROJECT WORK

5.1 WORK BREAKDOWN STRUCTURE (WBS)The WBS will be based on the Contract Deliverables derived from the Sole Source Scope of work. A detailed task plan will be developed with the contractor based on the deliverables as listed in 4.2.2

5.2 SCHEDULE ALLOCATION -PROJECT TIMELINE

Initiation phase – Oct 2019- Jan 2019

Planning phase –Jan 2020 – Mar 2020

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Implementation- April 2020 – Nov 2020

Closeout – Nov 2020 – Dec 2020

5.3 PROJECT BUDGET

ITEM COST ESTIMATE

LIMS VENDOR FOR INTEGRATION WORK

$230,000

STAFF BACKFILL $32,000

HARDWARE $136,000

IV&V INITIAL ASSESSMENT (IF REQUIRED)

$6,000

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

TOTAL $440,000

5.4 PROJECT TEAM5.4.1 PROJECT TEAM ORGANIZATIONAL STRUCTURE

The detailed team structure will be finalized once the vendor is on board. The PM will coordinate the overall project effort and provide guidance, reporting to the business owner and the program. The team will consist of SLD Toxicology bureau staff, the LIMS manager and Vendor staff.

5.4.2 PROJECT TEAM ROLES AND RESPONSIBILITIES

ROLE RESPONSIBILITY NAME FUNCTIONAL AREA

Business owner Provide Strategic Direction, and Steering within DOH

TWILA KUNDE SLD

PAGE | 15


ROLE RESPONSIBILITY NAME FUNCTIONAL AREA

Instrument users End users of LIMS and the instruments, people who set up and run the tests. Will perform UAT, and confirm requirements and design meet business need

LAB ANALYSTS

SLD

Staff Manager Bureau chief responsible for managing the analysts SAM KLEINMAN SLD

Lims Manager Manages the LIMS system from IT perspective. Will be responsible for presenting change requests to CMR

SARA LUCERO

DOH IT

Project Manager Overall Project coordination and management

ROSANNA DILL DOH ITSD PMO

Vendor Team Lead

Coordinates and helps plan vendor activities for the team

LABWARE Vendor

Vendor Staff Perform work for the project from vendor

LABWARE Vendor

5.5 STAFF PLANNING AND RESOURCE ACQUISITIONWe will complete this with the detailed task plan once contract is finalized

5.5.1 PROJECT STAFF

Resource Cost Estimate

Estimated Hours Availability Skill Set Work Product/Deliverable

PAGE | 16


5.5.2 NON-PERSONNEL RESOURCES

Project may choose to add backfill staff to free up lab analysts to work on project. The extent to which they may be needed is not yet determined

Resource Cost Estimate

Estimated units/hours Availability Source Work Product/Deliverable

ITSD Admin Internal ITSD Staff

Manage vendor payments

Staff aug Lab Analyst TBD SWPA Vendor

Perform day to day SLD analyst work while analyst works on project

Lab Supplies- Reagents and test samples

Current lab suppliers

For testing.

Compute hardware SWPA Vendor

Upgraded Instrument computers if needed

Instrument Software Vendor Instrument upgrade if needed and budget available

5.6 PROJECT LOGISTICSThe NM Scientific Laboratory is in Albuquerque. Work requiring instrument access will occur there. The Vendor will be on site for key activities such as kickoff and go live. Some of their work will be done remotely. Weekly meetings for the project team will be virtual.

5.6.1 PROJECT TEAM TRAINING

Training for instrument staff based on new functionality will be part of transition to operations planning, Other training is not anticipated for this project

6.0 PROJECT MANAGEMENT AND CONTROLS

6.1 RISK AND ISSUE MANAGEMENT

6.1.1 RISK MANAGEMENT STRATEGY

In general, for this project, risks will be tracked by the Project Manager on behalf of the team. Risks will be part of the regular reporting from the PM to the business owner and steering. Risk treatment strategies will be developed within the team and proposed to the business owner/steering committee for action approval.

PAGE | 17


6.1.2 PROJECT RISK IDENTIFICATION

Some project risks have already been identified. See Charter. Any on the project team can identify a new risk for recording by the PM. Additionally, anyone on the team can report an issue around a risk materializing.

6.1.3 PROJECT RISK MITIGATION APPROACH

Risks can be managed by acceptance, avoidance, sharing or reduction. The project team will perform an initial assessment of each risk and recommend an approach for managing it to the business owner for approval. Materialized Risks will be reviewed as needed to confirm the management approach is working or recommend a direction change.

6.1.4 RISK REPORTING AND ESCALATION STRATEGY

Risks will be reported to the Business owner and steering committee as part of regular reporting, or sooner via direct if risk management requires it

6.1.5 PROJECT RISK TRACKING APPROACH

Risks will be tracked by the Project Manager in a log available to the team in the Project Library.

6.1.6 ISSUE MANAGEMENT

6.1.6.1 Internal Issue Escalation and Resolution Process

Like Risks, anyone on the team can report an issue to the PM for tracking. Team members should try to resolve issues within the team first. Issues can be escalated through the PM to the business owner/project sponsor or to the vendor team as appropriate,

6.1.6.2 External Issue Escalation and Resolution ProcessIssues needing external escalation will be escalated by the PM to the business owner for further management escalation as needed,

6.2 INDEPENDENT VERIFICATION AND VALIDATION - IV&VThe 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.

6.3 SCOPE MANAGEMENT PLANScope will be defined and controlled by what is in the final Sole Source Determination document submitted to GSD.

6.3.1 CHANGE CONTROL

6.3.1.1 Change Control Process

This project Scope is reasonably well defined. Changes to task schedule/task content will be resolved at the project team level unless escalation to management/business owner is needed

PAGE | 18


6.3.1.2 Change Control Board (CCB)

DOH IT has developed a change control board and Change Management Review process for technical IT changes to DOH systems. Promotion of completed instrument configurations to Test and Production environments will be submitted to the board for approval per existing process. The LIMS Manager is tasked with doing this.

6.4 PROJECT BUDGET MANAGEMENT6.4.1 BUDGET TRACKING

For this project, budget will be tracked based on contract deliverables

6.5 COMMUNICATION PLAN

6.5.1 COMMUNICATION MATRIX

Will provide a completed matrix once team is fully assembled including vendor staff

6.5.2 STATUS MEETINGS

The project team will hold regular status meetings on a weekly basis. Timing may be adjusted based on project need. Additionally, the PM will hold status update meetings with the steering committee on a regular basis approximately monthly

6.5.3 PROJECT STATUS REPORTS

The PM will provide regular status reports to the Business owner and management.

6.6 PERFORMANCE MEASUREMENT (PROJECT METRICS)

6.6.1 BASELINES

Project Area Category Measure

Schedule schedule Will we finish on time?

Budget/Resource fiscal Have we overspent?

human Are people available to contribute as needed without being over committed?

Suitability/Quality Functionality Are all tests and results for each instrument automated correctly?

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Defects How many defects has testing revealed?

6.7 QUALITY OBJECTIVES AND CONTROLQuality will monitored as part of contract deliverable acceptance and testing, .

6.7.1 QUALITY STANDARDS

Standards and regulatory requirements for instrument test accuracy will be confirmed as part of the test process.

6.7.2 PROJECT AND PRODUCT REVIEW AND ASSESSMENTS

Overall the project will be reviewed by the SLD Lab Director, Toxicology bureau chief and Lab Analysts to determine if the automation succeeds in freeing up personnel and increasing Toxicoloy Lab testing throughput while maintaining test quality and without adding workload on the LIMS management side.

6.7.3 AGENCY/CUSTOMER SATISFACTION

The project manager will assess client satisfaction as part of regular reporting to the steering committee.

6.7.4 PRODUCT DELIVERABLE ACCEPTANCE PROCESSSLD expects LABWARE to supply all configuration files and LIMS system work electronically for appropriate storage in case the work has to be re-installed. Other documentation shall also be provided to SLD electronically, and in paper copies as needed for training, meetings etc.

6.8 CONFIGURATION MANAGEMENTArtifacts directly related to the LIMS software will be managed and maintained by the LIMS Vendor. Contract deliverable documents will be provided by the LIMS Vendor for placement in the project repository

6.8.1 VERSION CONTROL

The project team will agree on what will constitute major/ minor document revisions based on best practice and fit for the document type.

6.8.2 PROJECT REPOSITORY (PROJECT LIBRARY)

The primary project library is a Sharepoint site specific to this Project.

6.9 PROCUREMENT MANAGEMENT PLANThe primary procurement for this project is a contract based on a sole source with the existing LIMS vendor. The contract will be managed by ITSD. Additional procurements if needed will be sought through statewide price agreements. It is possible additional sole source procurements may be needed from instrument vendors.

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7. 0 PROJECT CLOSE

7.1 ADMINISTRATIVE CLOSE

7.1.1 CLOSE ACTIVITIES FOR PHASES AND THE PROJECT

7.1.1.1 Deliverable and activity completion

Team will confirm deliverables and activities appropriate to the timespan are complete and have been approved.

7.1.1.2 Documentation storage

Team will confirm documentation for deliverables and activities appropriate to the timespan are complete and stored appropriately for users who will need to access them later.

7.1.2 ADDITIONAL ACTIVITIES FOR PROJECT CLOSE.

7.2.1.1 Transition to operations

The team will ensure all transition to operations activities are completed and the Maintenance and Operations team are ready to take over and have the documentation they need to be able to add the project work to the standard maintenance and operational support processes already in place for this existing system.

7.2.1.2 Lessons Learned

The team will compile and document lessons learned from the project, and work to ensure relevant items are incorporated into processes for future projects.

7.2.1.3 Archive

The team will ensure project artifacts not needed for continuing work are archived appropriately and retained per state records policy

7.2 CONTRACT CLOSE

Once all contract deliverables are complete, approved and signed off on by the program, contractors will submit final invoices to DOH for processing. Once all invoices are paid, the Purchase order is administratively closed, and the contract and PO. are filed.

ATTACHMENTS

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Documents

NM DoIT€¦ · Web view23.01.2020 · Good, clear, timely communication is key to any project’s success. The project team, including the vendor will meet with each other on