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

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.

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.

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)

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

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

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.

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.

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

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

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

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  

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.  

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  

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  

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  

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  

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.  

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

Dr. Martina Q. McGarvey Director PA DEP Bureau of Laboratories (717)346-8618 mmgarvey@pa.gov Aaren S. Alger Chief, Laboratory Accreditation Program (717)346-8212 aaalger@pa.gov