1. National Environmental Monitoring Conference
Government Public Health and Private Environmental Laboratory Partnerships
National Environmental Monitoring Conference
New Orleans, LA
August 9, 2018

2. Laboratory Improvement Through Accreditation
Martina McGarvey, DM
Laboratory Director
Aaren Alger, BS
Laboratory Accreditation Program Chief
Pennsylvania Department of Environmental Protection Bureau of Laboratories
The PA DEP perspective: The Bureau of Laboratories is a full service environmental laboratory with a Laboratory Accreditation Program that accredits to state and TNI standards. The state standards are very similar to the TNI standard but more prescriptive. The PA lab became accredited in 2009 by the NJ NELAP AB.

3. Overview
Why PA implemented the TNI Standard and Quality (Management) System Approach? Similar to other states?
Getting started to implement the TNI Standard
What happens when we have FINDINGS in the audit process?
How do we afford accreditation fees?
Why did we make the decision to be NELAP accredited and how did we make it happen. Prior to 2009 we were accredited for DW only by US EPA Region III. In 2007 our laboratory director and two division chiefs retired. Prior to 2007 the previous leadership embraced the notion of NELAP accreditation but it did not happen, “We are not ready”. The time had come that the PA BOL had lost connection and the confidence of its clients the environmental programs, we needed laboratory improvement. The transition team for new management at the agency Executive level evaluated the state of the lab. As the acting director of the PA lab I understood that without NELAP (we were not going to accredit ourselves to PA state standards) accreditation we were not sustainable. We could not provide quality data and gain the confidence of our agency. Our data was good, valid and we had a terrific team of chemists, microbiologist, and assessors. We needed NELAP accreditation to prove we could not only improve our quality but document it, defend it, and continue laboratory improvement to meet our clients.

4. The Why - Purpose of Laboratory Accreditation
The laboratory accreditation program (LAP) was established to protect the public health, safety, welfare, and the environment by ensuring the accuracy, precision, and reliability of data generated by environmental laboratories.
An accredited laboratory will more likely generate data of appropriate quality for a particular analysis because of its quality system.
Why PA Implemented the TNI Standard. Quality System or Management System (ISO 17025)

5. Guiding Principles of TNI Standard-Getting Started
Flexible: Allow labs freedom to use experience and expertise in performing work and allow for new and novel approaches. Specify the What and avoid where possible the How To.
Auditable: Sufficient detail so that the assessors can evaluate laboratories consistently.
Practical and Essential: Necessary policies and procedures that should not place an unreasonable burden upon laboratories.
Widely Applicable: Applicable to laboratories regardless of size, complexity and scope of services.
Appropriate: Ensure that data is of known quality and that the quality is adequate for the intended use.
Not prescriptive, we are all different, different sizes, different disciplines, chemistry and/or microbiology

6. TNI Standard TNI Standard Requirements
Management
Technical
Records
QA Manual
Personnel QC
Analyze 2 PT samples per year and pass 2 out of 3
Assessment every 2 years

7. TNI Quality System Module
Section 4: Management Requirements
Implementation of a quality system
Management requirements
Documents and records
Internal assessments
System controls and improvements
Comparable to ISO 9000, these requirements are good management practices to ensure analyses are performed in an orderly and structured way.

8. TNI Quality System Module
Section 5: Technical Requirements
Technical competence of staff
Validity and appropriateness of test methods
Traceability of measurements
Instrument calibration
Testing environment
Sampling, handling and transportation of samples
Quality assurance of test data
Reporting
These requirements focus on ensuring reliable and accurate data.

9. Continued Compliance - Improvements
Corrective Action Report
Root Cause Determinations
Corrective Actions
Follow-up on Effectiveness of Corrective Actions
Self-Monitoring
Re-training of Analysts
Upgrade/Purchase New Instrumentation
Manage staff, objectives, train, follow up
Train, Manage Staff, Clear Corporate Quality Stds embedded in culture. You can’t afford bad data. ROI

10. Tips from PA BOL for Lab Improvements
Leadership
Practice On-sites – Lab Improvement
Findings for one section may be applicable to lab
Recommendations – may be simplified
Auditors are not the enemy
There is no such thing as a perfect score

11. Process for Lab Improvement
Proactive Improvement Measures
Laboratory Initiated
Preventive
Reactive Improvement Measures
Response to Assessment/Deficiency Report
Customer Complaints
Mandated by Accreditation Body

12. Proactive Improvement Measures
Management Commitment to Quality –
beyond compliance
corporate culture
Defined Chain of Command and Reporting Responsibilities
Ethics Training
Continual Re-Assessment of Analytical Capability/Laboratory Capacity
Management Reviews
Continuous Monitoring and Training
External Audits/Consultants
Preventive Instrument Maintenance
Standard Operating Procedures

13. Assessment/Audit Process for Lab Improvement
Assessment of Laboratory Operations
Interviews and thorough data review
SOPs, PT performance, training, recordkeeping, sample receipt and handling procedures, equipment, etc.
Assessment of Laboratory Personnel
Laboratory Supervisor qualifications and capability, analyst training and competence
Complaint Investigations
Complaints from other laboratories, customers, employees, DEP Programs, NELAP accreditation bodies, etc.

14. Identify Areas of Improvement
Absentee/Ineffective Laboratory Management
Failure to Report Accurate Results
Data Approval by Untrained/Unqualified Analysts
Improper Manual Integrations
Improper Sample Analysis
Use of Malfunctioning Equipment
Analyst Failures
Improper Handling of PT Samples
Drinking Water Reporting Problems
Dry-Labbing/Falsification of Data Records

15. Return to Compliance and Lab Improvement
Corrective Action Report
Root Cause Determinations
Corrective Actions
Follow-up on Effectiveness of Corrective Actions
Self-Reporting/Notification to DEP
Re-training of Analysts
Upgrade/Purchase New Instrumentation
Hire New Staff
Termination of Staff
Notice to Clients

16. Return to Compliance and Lab Improvement
Consider contracting with a third party auditor for training, practice audits or consulting to assist with corrective actions
Internal Audits of some or all of past data, reissue amended test reports
Rotate Analysts/Cross-Training Opportunities
Participate in training offerings from instrument manufacturers
Attend TNI Meetings, participate in standard development

17. Lab Improvements Limit Resolution of Liability
Lab Accreditation Act provides for remedies available by law
DEP can order corrective actions
Designed to stop harm caused by violations
Administratively or in court
Unilaterally or with consent
Civil Penalties
Deter; remove economic benefits of noncompliance
Unilateral or with consent
Criminal enforcement – PA Attorney General, EPA

18. Potential Consequences of Non-Compliance Not Addressed
Consent Order and Agreement
Consent Assessment of Penalties
Disqualification of a Lab Supervisor
Denial, Suspension, Revocation of Accreditation
Civil Enforcement in courts
Criminal Investigation, Prosecution, etc.

19. In Summary Accreditation reflects capability
Accountability and compliance is the laboratory’s responsibility
Management is the first line of defense
Focus on Preventive Action and Root Cause Investigations
Findings are for laboratory improvement
Reliable and defensible data means safer and healthier environments and citizens

20. Dr. Martina Q. McGarvey Director PA DEP Bureau of Laboratories (717) Aaren S. Alger Chief, Laboratory Accreditation Program (717)