Webinar

Managing Data Quality in an Environmental Laboratory 12/10/2015

Speaker Kathryn Wangsness, MHA, Chief, Office of Laboratory Services, Arizona State Public Health Laboratory, Phoenix, AZ Kathryn Wangsness is Chief and Quality Assurance Manager for the Office of Laboratory Services at the Arizona Department of Health Services. Since 1997, she held positions as a water chemist, blood alcohol consultant, federal/state laboratory licensure surveyor, and quality assurance manager. Since 2008, Ms. Wangsnesss has served as Chief for the Office of Laboratory Services while also continuing in her role as Quality Assurance Manager. She is an approved EPA certification officer for inspecting inorganics, organics, and microbiology compliance testing in drinking water laboratories. Objectives At the conclusion of this program, participants will be able to:  Discuss the management of data quality in an environmental laboratory  Describe how each staff role is integral to this process Continuing Education Credit CE credit is not available for this program, but you will receive a Certificate of Attendance. Evaluation/Certificate of Attendance Process Continuing education credit is not available for this program. Individuals who successfully complete the program and evaluation by 10/20/2016 will receive a Certificate of Attendance. Go to https://www.surveymonkey.com/r/100-659-15pr to complete the evaluation. 1. After you complete the evaluation, you will automatically receive the Certificate of Attendance. 2. Type or print your name on the certificate. Archived Program The archived streaming video will be available within two days. Anyone from your site can register view the program. URL: http://eventcenter.commpartners.com/se/Meetings/Playback.aspx?meeting.id=816040 Comments, opinions, and evaluations expressed in this program do not constitute endorsement by APHL. The APHL does not authorize any program faculty to express personal opinion or evaluation as the position of APHL. The use of trade names and commercial sources is for identification only and does not imply endorsement by the program sponsors. © This program is copyright protected by the speaker(s) and APHL. The material is to be used for this APHL program only. It is strictly forbidden to record the program or use any part of the material without permission from the author or APHL. Any unauthorized use of the written material or broadcasting, public performance, copying or re-recording constitutes an infringement of copyright laws.

This publication was developed under Assistance Agreement No. 83483301 awarded by the US Environmental Protection Agency. It has not been formally reviewed by EPA. The views expressed in this document are solely those of APHL and EPA does not endorse any products or commercial services mentioned in this publication. This publication was funded 100% with federal funds. $1,200,000 in federal funds supported this program.

The Association of Public Health Laboratories (APHL) sponsors educational programs on critical issues in laboratory science. For more information, visit www.aphl.org/courses

OBJECTIVES Analysis. Answers. Action.

• Know what quality means

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• Understanding how to manage data quality

Managing Data Quality in an Environmental Laboratory

• How you fit into overall quality

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Analysis. Answers. Action.

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Defining Quality • Quality Assurance (QA) • Quality Control (QC) – Encompasses entire program which data evaluation is based – Methods – Regulations – Quality Control – Safety – Good Lab Practices – Proficiency samples

DATA QUALITY Defining it

Analysis. Answers. Action.

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– Validates that work performed – Part of the testing process – Includes • • • • • •

Blanks Controls Spikes Duplicates IDLs/MDLs And more

Analysis. Answers. Action.

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Quality Management System

Quality Management System

• Encompasses not only QA and QC but also areas of management such as:

• As part of the QMS, laboratories create and should use:

– Job descriptions – Purchasing supplies and services – Environmental conditions/building – Sampling plans – Laboratory certifications/accreditations (EPA, States, TNI)

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– Quality Assurance Plan • This provides the foundation of the lab’s quality system • All staff should be aware of the plan

– Information Management Systems • Critical component of tracking samples and serves as a repository for all lab information – E.g. sample info, chemical inventory, reagent/standard tracking, data trends, analyst training

Analysis. Answers. Action.

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Analysis. Answers. Action.

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Data Quality • Final results from data are scientifically valid and defensible and are of known and acceptable precision and accuracy

WHY IS IT IMPORTANT

– Includes all aspects of the QMS (QA and QC)

What does it mean?

– A goal on how to produce the data

Analysis. Answers. Action.

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Analysis. Answers. Action.

Importance

How do we do this?

• Providing the end data user with usable information to perform appropriate actions to protect the environment and the public

• Be involved from the beginning

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– Sampling • Ensure samplers and submitters understand what is needed to provide the data user with usable data • Understand what the end goal of the project is

– pH checked at a treatment facility – Nitrate checked for a well – Pesticides checked in soils

Analysis. Answers. Action.

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– compliance, screening, or something else

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Analysis. Answers. Action.

How do we do this?

Communication

• Be involved from the beginning

• Establish and maintain with clients

– Requirements from the client

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– Questions by laboratory

• What does the client need for the data?

• Sample quality • Test requested

– Chain of custody – Additional quality control checks/tighter criteria – Specific methods

– Questions by client • Lab tours • Understanding the results

Analysis. Answers. Action.

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Analysis. Answers. Action.

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Quality Assurance Program

Quality Assurance Program

• Reducing the overall total data error

• Reducing the overall total data error

– SOPs with proper QA, calibration, and maintenance – Proper method for analyte of interest and detection level needed – Proper storage of samples, reagents, and equipment

Analysis. Answers. Action.

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– Sample identification and security – Data recording, reduction, review and storage

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What does this mean for you?

Analysis. Answers. Action.

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What does this mean for you?

• Ensuring instrumentation/equipment are functioning properly

• Ensuring precision – repeatability of values (duplicates) • Ability to see analyte of interest – spikes • Ensure review of the data

• Documentation and record keeping

– Internal audits – Electronic reviews: data files from instruments

– SOPs, logbooks, CofAs

Analysis. Answers. Action.

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Analysis. Answers. Action.

What does this mean for you?

What does this mean for you?

• Ability to reproduce final results by paper (hard copy) and electronics

• Training/competency/capability

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– Ensure that not only trained on specific tests, but on ethics, quality assurance

• Ensure that all follow good laboratory practice – Ethical considerations – is what you are doing appropriate

Analysis. Answers. Action.

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Analysis. Answers. Action.

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What does this mean for you? • Following regulations/guidelines – EPA • Safe Drinking Water Act • Clean Water Act

RESPONSIBILITY

– States

Who is responsible?

• Specific state requirements

Analysis. Answers. Action.

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Analysis. Answers. Action.

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Everyone is responsible • Throughout the lab everyone participates and contributes to the overall management of the final product (data quality)

You and your actions are responsible for managing data quality

– Analysts – Lab Technicians – QA Manager/Officer – Managers/Supervisors – Laboratory Director – Support staff

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Analysis. Answers. Action.

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Managing Data Quality • Understanding of QA, QC and QMS – How they fit together

• Awareness of client needs • Being aware of the QA Program • Everyone’s involvement impacts the outcome

CONCLUSIONS

Analysis. Answers. Action.

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Analysis. Answers. Action.

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Resources • Additional and expanded learning opportunities: – Webinars (archived and upcoming) • http://www.aphl.org/training/teleconf/Pages/default.aspx

THANK YOU

• Pre-recorded sessions – Environmental has 4 currently including Laboratory Fraud (Ethics)

– The Quality Improvement Forum • http://www.aphl.org/aphlprograms/lss/performance/pages/qualityimprovement.aspx

– The Member Resource Center • http://www.aphl.org/MRC/Pages/default.aspx Analysis. Answers. Action.

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Questions and Contact Information Kathryn Wangsness, MHA Chief, Office of Laboratory Services Quality Assurance Manager Arizona State Public Health Laboratory [email protected] 602-364-0724

Analysis. Answers. Action.

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Comments/concerns about this webinar? Email: [email protected]

Analysis. Answers. Action.

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