OELA/ORELAP Annual Environmental Laboratory Conference ORELAP 2017 UPDATE Stephanie B Ringsage, BS, MT (ASCP) Laboratory Compliance Section Manager April 17, 2018 OSPHL Laboratory Compliance Section ORELAP

ORELAP OSPHL Laboratory Compliance Section

ORELAP OSPHL Laboratory Compliance Section

General Overview of the Laboratory Compliance Section Clinical and Environmental Clinical Laboratory Regulations Oversee a total of 3,109 laboratories in the state of Oregon. 261 Certificate of Compliance 628 Certificate of PPMP 1,794 Certificate of Waiver 173 Certificate of Accreditation 99 Health Screen Testing Permit (HST) 154 Substance of Abuse Registry (SOA) Personnel- 1 full time CLIA inspector 1 part time CLIA inspector ORELAP OSPHL Laboratory Compliance Section

General Overview of the Laboratory Compliance Section Environmental Laboratories ORELAP 151 ORELAP accredited labs 66 Oregon In State labs 22 Drinking water labs that accept public samples 11 Drinking water labs that do not accept public samples 25 Cannabis labs 8 environmental labs 62 Out of state labs 52 Drinking water labs that accept public samples 6 Drinking water labs that do not accept public samples 4 Environmental labs 23 Secondary ORELAP accredited ORELAP OSPHL Laboratory Compliance Section

Brief overview of the OHA and the Oregon Public Health Division The Oregon State Public Health Laboratory (OSPHL) of the Oregon Health Authority (OHA), Public Health Division (PHD) in concurrence with Oregon Department of Environmental Quality(DEQ) and Oregon Department of Agriculture was granted authority by the Oregon State Legislature to implement an laboratory accreditation program. Established by 1999 Oregon Legislature. Approved by the National Environmental Laboratory Accreditation Program (NELAP) to act as an accrediting authority on February 9, 2000. Oregon Environmental Laboratory Accreditation Program (ORELAP) ORELAP OSPHL Laboratory Compliance Section

The National Environmental Laboratory Accreditation Program Institute (TNI) ORELAP is committed to following the current TNI standards adopted at the Annual conference in July 2009. Accreditation of environmental laboratories by ORELAP is based on the 2009 TNI standard (and any amendments) as described in OAR 333-064-0005 to 333-064-0110 ORELAP must meet all requirements to maintain its status as a NELAP accrediting body. This includes having ORELAP approved assessors and certifying laboratories that comply with the TNI standards as specified in the OAR rules. ORELAP OSPHL Laboratory Compliance Section

Mandated laboratories to be ORELAP accredited ORELAP accredits qualified laboratories for testing under the Clean Air Act (CAA), Clean Water Act (CWA), Resource Conservation and Recovery Act (RCRA) and the Safe Drinking Water Act (SDWA) ORELAP accredits Cannabis testing laboratories under ORS 475B.550 to 475B.590 Drinking water and cannabis testing laboratories are mandated to be ORELAP accredited. ORELAP goal is to have all assessors to be certified for microbiology and chemistry (organic/inorganic) as EPA DW CO. These rules are for the purpose of implementing Oregon Revised Statutes (ORS) 438.605 to 438.620, 448.280 and the Oregon Drinking Water Quality Act of 1981 ORELAP OSPHL Laboratory Compliance Section

ORELAP OSPHL Laboratory Compliance Section

ORELAP Organizational Chart Personnel Consist of the following: Executive Team: Dr. John Fontana, OSPHL Lab Director Brian Boling, DEQ Administrator and Kathleen Wickman, Depart. Of Agriculture Traditionally the Executive Team have played a limited role in the direct operations of the program. However, they have been actively involved in the overall management of the program since 2016, especially Dr. John Fontana ORELAP staff anticipates a continual active support from the ORELAP Executive Team. ORELAP OSPHL Laboratory Compliance Section

ORELAP Assessors: Liz Garcia-Lead ORELAP Assessor (hired date October 13, 2015) Liz was a DEQ chemist and assisted ORELAP with on site assessment prior to being hired on full time with ORELAP Liz has worked so very hard and has been a great asset to the program . Certifications: TNI refresher course for assessors March 6,2017 EPA Drinking Water Certification Officer for microbiology June 2017 crypto and giardia October 2017 RadChem February 2018. ORELAP OSPHL Laboratory Compliance Section

ORELAP Assessors Alia Servin ORELAP Assessor. Hired March 6,2017 . Alia earned her B.Sc. and Ph.D. in Chemistry at the University of Texas at El Paso with a focus on environmental and analytical chemistry. She is a former agricultural post-doctoral research scientist form the Connecticut Agricultural Experiment Station. Certifications: TNI assessor certification March 27, 2017, EPA Drinking Water Certification Officer for inorganic chemistry in June 2017 crypto and giardia October 2017 RadChem February 2018 ORELAP OSPHL Laboratory Compliance Section

ORELAP Assessors cont. Ryan Pangelinan ORELAP assessor -Hired date March 20,2017 Earned his B.Sc. degree in Biology/Chemistry at the Eastern Oregon University. Ryan comes with over nine years of laboratory experience working in an ORELAP accredited environmental laboratory and more recent working as a Chemist 2 from DEQ. Certifications: TNI assessor certification March 27, 2017 EPA Drinking Water Certification Officer for organic chemistry in June 2017 ORELAP OSPHL Laboratory Compliance Section

ORELAP Assessors RaeAnn Haynes came out of Retirement to help ORELAP as a temporary part time ORELAP assessor. Her hired date was July 16, 2016 and her position ended June 8, 2017. She will be coming back June 2018 to help out with onsite assessments RaeAnn had retired from DEQ in 2014 as a DEQ Chemistry 2 and Chemistry 3 and Drinking Water assessor. Her last positions she held while working at DEQ were Inorganic Section Manager for 12 years and concurrently had served as a Technical Service Manager for the last 3 years prior to her retirement. ORELAP OSPHL Laboratory Compliance Section

Interagency Agreement with DEQ DEQ staff: Scott Hoatson, DEQ QA Officer/ORELAP QA Officer Heather Cayton, DEQ/ORELAP assessor Sophia Cain (Caggiano), DEQ/ORELAP assessor Scott has been a resource of support and has stepped up to be apart of the RAC meetings for Oregon Medical Marijuana Program (OMMP) in 2017. Scott will continue to provide technical guidance to ORELAP Heather had completed the TNI assessor refresher course March 2017 Sophia had earned her TNI basic training certification March 27, 2017 ORELAP OSPHL Laboratory Compliance Section

ORELAP staff in summary ORELAP is in a transitional phase as we go through the process to post the position for ORELAP Program Manager. At this time the program manager’s technical and administrative responsibilities have been delegated to the three assessors and LC manager in the interim. Liz Garcia, Alia Servin and Ryan Pangelinan continue to conduct on site assessments therefore their immediate availability to answer technical questions will be limited The LC manager will be the primary contact at this time to assure timely responses to your inquiries, with the intent to forward the technical inquires to the next available ORELAP staff ORELAP OSPHL Laboratory Compliance Section

Average number of days from assessment to initial ORELAP report AB's-30 day requirement for final report according to the TNI Standard: V2M3-ISO-2009: 6.12.2. Review of 2017: Jan to Dec- ORELAP assessors conducted 58 on-site assessments Average number of days from assessment to initial ORELAP report 23 days Moving forward in our transition phase- we will be bringing back RaeAnn Haynes, and using DEQ Assessors ORELAP OSPHL Laboratory Compliance Section

ORELAP goals We are striving to provide all resources and training opportunities to ensure each assessor will be cross trained in all fields of accreditation. As our staff collaborate, cooperate and become consistent in data review and onsite assessments the ORELAP program will improve. Ultimately, our program is trying to be more proactive rather than reactive to the constant challenges of regulating laboratories. We strive to assure the quality testing in environmental laboratories keep Oregonians healthy. Our program has an impact on not just the laboratories seeking ORELAP accreditation, but has direct impact on other agencies that are within and outside the Public Health Division (PHD) centers. ORELAP OSPHL Laboratory Compliance Section

Goals to develop program relationships Working closely with the OMMP OLCC and ODA regarding cannabis issues Lead testing for Child Care facilities-New rules require child care facilities to test for lead in drinking water. Early Learning Division (ELD) from Oregon Department of Education will be sending out letters to child care providers by April 30, 2018. OHA will have a letter prepared for the ORELAP Drinking Water laboratories Working with Drinking Water program and assuring ORELAP accredited labs are submitting accurate, timely complete results for drinking water facilities. Seeking expertise and guidance from DEQ/ORELAP QA officer and from the Executive Team representing OHA, DEQ and ODA ORELAP OSPHL Laboratory Compliance Section

Contact ORELAP Liz Garcia lizbeth.garcia@state.or.us 503-693-4115 Alia Servin alia.d.servin@state.or.us 503-693-4130 Ryan Pangelinan ryan.pangelinan@state.or.us 503-693-4129 Stephanie Ringsage stephanie.b.ringsage@state.or.us 503-693-4126 ORELAP OSPHL Laboratory Compliance Section