Environmental Monitoring Plan Browns Island Landfill Marion County Prepared for Marion County Department of Public Works Environmental Services 5155 Silverton Road NE Salem, Oregon 97305 Prepared by Parametrix 700 NE Multnomah, Suite 1000 Portland, OR 97232-4110 T. 503.233.2400 T. 360.694.5020 F. 503.233.4825 www.parametrix.com March 18, 2013 │ 275-2063-007 CITATION Parametrix. 2013. Environmental Monitoring Plan Browns Island Landfill Marion County. Prepared by Parametrix, Portland, Oregon. March 18, 2013. Environmental Monitoring Plan Browns Island Landfill Marion County Marion County Department of Public Works TABLE OF CONTENTS 1. INTRODUCTION ................................................................................................ 1-1 1.1 EMP HISTORY ..................................................................................................... 1-1 1.2 PLAN ORGANIZATION ...................................................................................... 1-2 1.3 SITE LOCATION AND OPERATING BACKGROUND .................................... 1-2 1.3.1 Site Location ................................................................................................. 1-3 1.3.2 Site Description ............................................................................................ 1-3 1.3.3 Site Developments ........................................................................................ 1-3 1.3.4 Composting Facility ..................................................................................... 1-3 1.3.5 On-Site Water Supply................................................................................... 1-4 1.3.6 Adjacent Properties ...................................................................................... 1-4 1.3.7 Site Monitoring ............................................................................................. 1-5 1.4 GEOLOGIC AND HYDROGEOLOGIC CONDITIONS ..................................... 1-5 1.4.1 Geologic Conditions ..................................................................................... 1-6 1.4.2 Hydrogeologic Conditions............................................................................ 1-6 2. SITE MONITORING BACKGROUND ................................................................ 2-1 2.1 MONITORING WELL NETWORK ..................................................................... 2-1 2.1.1 Network Development.................................................................................. 2-1 2.1.2 Completion Depths ....................................................................................... 2-2 2.1.3 Background Monitoring ............................................................................... 2-2 2.1.4 Network Adjustments ................................................................................... 2-2 2.1.5 Well Survey .................................................................................................. 2-3 2.2 GROUNDWATER QUALITY .............................................................................. 2-3 2.2.1 GQAR Findings ............................................................................................ 2-4 2.2.2 GQAR Update Findings ............................................................................... 2-4 2.2.3 Annual Monitoring Report Findings ............................................................ 2-5 2.2.4 Organic Constituent Detections .................................................................... 2-5 2.2.5 River Water Quality ..................................................................................... 2-7 3. GROUNDWATER MONITORING PLAN ........................................................... 3-1 3.1 GROUNDWATER QUALITY MONITORING POINTS .................................... 3-1 3.2 MONITORING SCHEDULE ................................................................................ 3-2 3.3 COMPLIANCE BOUNDARY AND CONCENTRATION LIMITS .................... 3-2 3.4 REVIEW OF GROUNDWATER QUALITY RESULTS ..................................... 3-2 3.4.1 Routine Event Data Review Action Criteria ................................................ 3-3 3.4.2 Resampling Event Data Review Action Criteria .......................................... 3-3 3.5 DATA ANALYSIS AND EVALUATION ............................................................ 3-4 3.5.1 Data QA/QC ................................................................................................. 3-4 3.5.2 Data Presentation and Analysis .................................................................... 3-4 March 18, 2013 │ 275-2063-007 i Environmental Monitoring Plan Browns Island Landfill Marion County Marion County Department of Public Works TABLE OF CONTENTS (CONTINUED) 3.6 REPORTING.......................................................................................................... 3-5 3.6.1 Annual Water Quality Monitoring Report .................................................... 3-5 3.6.2 DEQ Laboratory Split Sampling Report ...................................................... 3-6 3.7 REDUCTION IN MONITORING ......................................................................... 3-7 4. REFERENCES ................................................................................................... 4-1 APPENDICES A Solid Waste Disposal Site Closure Permit Number 255 B Monitoring Well Logs, 1997 Well Evaluation & Upgrade Report C Well Logs on Record - Sections 29 thru 32 D Property Owners and Zoning within ½-mile of the Site E Nitrate Investigation – 2007/2008 ATTACHMENT A Sampling and Analysis Plan LIST OF FIGURES 1 Site Location 2 Facility Map 3 Aerial Site Map 4 North/South Cross-Section 5 Well Cross-Section A-A’ LIST OF TABLES ii 1 Monitoring Well Summary Data 2 Sample Location Summary – 1974 through 2000 3 Water Quality Sample Locations, Frequency, and Schedule 4 Water Quality Monitoring Parameters March 18, 2013 │ 275-2063-007 Environmental Monitoring Plan Browns Island Landfill Marion County Marion County Department of Public Works 1. INTRODUCTION This March 18, 2013 Environmental Monitoring Plan (EMP) for the Browns Island Landfill (BI) is an update completed to reflect changes to the site’s groundwater monitoring program that have occurred since development of the April 26, 2001 EMP. Select elements of the April 26, 2001 EMP were updated on September 22, 2005. This EMP for BI address environmental monitoring requirements set forth in Section 14 of Solid Waste Disposal Site Closure Permit Number 255, issued on May 4, 2006, for BI. A copy of the BI Solid Waste Disposal Site Closure Permit (the closure permit) is presented in Appendix A for reference purposes. Environmental monitoring is required at solid waste disposal facilities to evaluate the performance of engineered control and containment systems and the magnitude and significance of any leachate or gas release impacts from the landfill on human health, welfare and safety, and the environment (DEQ 1996). Environmental monitoring at the BI consists of groundwater quality monitoring. This EMP update considers site-specific conditions to provide a monitoring program that address closure permit requirements while being protective of human health, welfare and safety, and the environment. The Browns Island Landfill operated as a municipal solid waste disposal facility for the City of Salem and surrounding Marion County area from April 1967 until September 1986 with final closure approval granted in September 1987. The total area of the landfill complex is approximately 87 acres. An unfilled approximately 8 acre area located near the north central portion of the landfill is currently being filled with construction and demolition debris under Solid Waste Disposal Site Permit Number 399. A 4.5-acre composting facility located on the east central portion of the landfill was constructed in September 1999. 1.1 EMP HISTORY Groundwater quality conditions at the site have been monitored through a network of monitoring wells since 1974. The wells were originally sampled by the DEQ Laboratory on a semi-annual frequency until March 1995 when Marion County assumed site monitoring. Following county assumption of site monitoring in 1995, the April 19, 1996 EMP was completed as required by the closure permit issued on October 11, 1995. The EMP was updated on April 26, 2001 to reflect monitoring modifications and adjustments that had occurred since completion of the April 19, 1996 EMP. These modification and adjustments were based on additional site characterization and data analysis that resulted in the recommendation and approval for several adjustments and modifications to the facility’s groundwater monitoring program. Site activities completed between the April 19, 1996 and the April 26, 2001 EMPs included: • Monitoring Well Evaluation – An evaluation of the monitoring well network was completed in 1997 to assess the characteristics and integrity of the existing monitoring wells at the site. This evaluation effort and findings are presented in the Monitoring Well Evaluation Plan (Parametrix 1997a) and the Monitoring Well Upgrade Report (Parametrix 1997b). Appendix B includes the 1997 monitoring well evaluation plan and upgrade report along with associated correspondence. • Groundwater Quality Assessment – A Groundwater Quality Assessment Update Report (GQAR) (Parametrix 1998) was completed to further evaluate groundwater quality conditions at the site, evaluate facility impacts to the Willamette River, and to modify the monitoring well network based on the report findings. The 1996 BI March 18, 2013 │ 275-2063-007 1-1 Environmental Monitoring Plan Browns Island Landfill Marion County Marion County Department of Public Works Groundwater Quality Assessment Report (Parametrix 1996) compiled and evaluated available groundwater quality data collected at the site since April 1985. Select portions of the April 26, 2001 EMP were updated on September 22, 2005 to reflect modifications and adjustments that had occurred to the site’s groundwater monitoring program. Specifically, the September 22, 2005 EMP update incorpoarated permit-specific concentration limits approved by the DEQ in a letter dated May 5, 2005. This March 18, 2013 EMP update incorporates modification and adjustments that had occurred to the site’s groundwater monitoring program since the September 22, 2005 EMP update. Monitoring modifications and adjustments since 2005 include use of dedicated sampling pumps, low-flow sampling methodology, and adjustments to the site’s sample analysis schedule. This 2013 EMP update also identifies changes that have occurred in land use of properties adjacent to the landfill complex and results of a nitrate investigation completed in 2007 and 2008. 1.2 PLAN ORGANIZATION The DEQ’s Solid Waste Permit Guidance (DEQ 1996) was referenced in the development of this plan. This EMP update maintains the structure originally presented in the April 26, 2011 and is organized in the following manner: • Section 1 - Introduction. This section presents site location and operations background, site characterization activities, geologic and hydrogeologic conditions, and area climate. Current and proposed uses of properties adjacent to the site are also described. • Section 2 – Site Monitoring. This section presents background information on the site’s monitoring history. The groundwater monitoring network established at the site is described. Historical groundwater quality conditions are presented. • Section 3 – Groundwater Quality Monitoring Plan. This section describes groundwater quality monitoring program for the site and monitoring elements such as schedule, analysis, data review, evaluation, and reporting. • Attachment A contains a site-specific Sampling and Analysis Plan (SAP). The BI SAP describes the procedures recommended for obtaining and documenting water quality samples collected at the site. EMP appendices contain the following supporting information: 1-2 • On-site well logs with installation details and recorded upgrades (Appendix B). Documentation associated with a well evaluation and upgrades completed during 1997 are also presented. • Well logs on recorded at the Oregon Water Resource Department for Township 7 south, Range 3 west, Sections 29 through 32 (Appendix C). As indicated on a map contained in Appendix C, portions of BI are situated in four sections. The Marion/ Polk County line is located in the middle of the Willamette River • Landowners and property zoning within a half-mile radius of the site (Appendix D). This listing includes landowners located in both Marion and Polk Counties. • Activities and findings associated with a nitrate investigation completed during 2007 and 2008 (Appendix E). The material was presented in the 2007 and 2008 BI Annual Water Quality Monitoring Reports. March 18, 2013 │ 275-2063-007 Environmental Monitoring Plan Browns Island Landfill Marion County Marion County Department of Public Works References cited are presented in Section 4. Attachment A to the EMP contains the SAP. There are two attachments associated with the SAP. Attachment 1 presents sampling field data sheets. Attachment 2 contains an electronic file of the current designated laboratories quality assurance program (QAP). This QAP is contained on a compact disc. It is expected that elements of this EMP will continue to be revised from time to time as site conditions and monitoring objectives change. Consequently, this EMP is presented in threering binder format to allow for portions of the document to be updated or amended without full plan revision. 1.3 SITE LOCATION AND OPERATING BACKGROUND Background information regarding the site’s location, setting, and operation is presented along with an overview of geologic and hydrogeologic conditions based on findings presented in the GQAR Update. 1.3.1 Site Location The Browns Island Landfill is located in Marion County approximately 1.5 miles west of Salem, Oregon (Figure 1). The site is located in the northeast ¼ of the northeast ¼ of Section 31 and the northwest ¼ of Section 32, Township 7 South, Range 3 West and situated on Browns Island, a Quaternary (Holocene) river alluvium deposit. Browns Island is bordered by the Willamette River on its north and west sides, and by unnamed interconnecting sloughs on its south and east sides. The landfill complex (total area of approximately 87 acres) is enclosed within a flood protection berm that is elevated approximately two feet higher than the 100-year flood level. The site is located in and bounded by an area zoned as urban transition. The area around the site was historically used for agricultural purposes but has more recently transitioned over to conservation reserve enhancement use in an effort to protect environmentally sensitive land, decrease erosion, restore wildlife habitat, and enhance water quality in the floodplain area adjacent to the Willamette River. Figure 2 presents a facility site map based on a May 8, 2012, aerial photograph of the site. 1.3.2 Site Description BI operated as a municipal solid waste disposal facility for the City of Salem and the surrounding Marion County area from April 1967 until September 1986. The Department of Environmental Quality (DEQ) granted final closure approval in a letter dated September 8, 1987. Landfilling began in the central portion of the site in 1967 and expanded onto City and County land in the mid to late 1970s. From 1979 through 1986, landfill expansion was toward the west onto adjacent private (former Trussell) property. The approximate fill thickness is 35 feet in the older eastern portion of the site and 40 feet in the western area of the landfill. The County secured water rights appurtenant to the former Trussell property and a major portion of the adjoining City of Salem property and purchased the Trussell property in 1997. In 2003, surface water irrigation rights were leased back to the State of Oregon as part of the Conservation Reserved Enhancement Project completed at the site. When the use of the site as a municipal landfill was terminated, there remained an unfilled area (a former gravel pit) of approximately eight acres located near the north central portion of the landfill (Figure 2). This unfilled area, originally bordered on the north by the protection March 18, 2013 │ 275-2063-007 1-3 Environmental Monitoring Plan Browns Island Landfill Marion County Marion County Department of Public Works berm and by completed areas on all other sides, is currently being filled with construction and demolition debris under Solid Waste Disposal Site Permit Number 399. 1.3.3 Site Developments Several site developments have occurred since completion of the 1996 EMP. These developments include construction of a composting facility over a portion of the eastern fill area; conversion of the former Trussell domestic water well to an operations water supply well; and conversion of land north and east/southeast of the landfill from cropland through conservation reserved enhancement program to become part of the Minto-Browns Island Park complex. Aggregate mining is occurring east of the site with a plan to ultimately create a lake that would be integrated into the park complex. 1.3.4 Composting Facility Construction of the BI composting facility was completed in September 1999. The facility consists of an approximately four-acre asphalt composting pad. A stormwater collection and management system and a water supply system were developed for the facility. The location of the composting pad is shown on Figure 2. The BI composting facility (BICF) is scheduled to receive and process up to 5,000 tons of Type 1 feedstocks (primarily source-separated yard and garden wastes) material per year. Yard debris is received from various County and City sponsored yard cleanup events held within Marion County. Yard debris is delivered to the BICF by county, city, public, and franchise waste haulers during specific collection events. The volume of incoming yard debris is recorded and unloaded on a portion of the asphalt pad and shredded using an on-site tub grinder. The shredded yard debris is formed into windrows, watered and turned as required for the composting process. All composting activities occur on the asphalt pad. The BICF Operations Plan further describes composting operations. 1.3.5 On-Site Water Supply In 1998 the former Trussell domestic water supply well was upgraded and converted to an on-site nonpotable limited use water supply source primarily for dust control on landfill access roads, routine equipment wash down and cleaning, watering of compost to maintain optimal moisture content, and fire suppression. As part of the BICF development, an underground pipe was constructed from the well pump house to the compost facility. The pipeline is designed to provide water to hydrants at the BICF. Water from the hydrants is used to wet and cool the compost. This well draws from the marine sediments bedrock unit that underlies the site as described in Section 1.4. Water in this deeper rock unit is commonly high in dissolved solids and iron (Sweet 1987). A flow meter and totalizer is installed on the well. The water supply well is sampled on the same frequency for the same parameters as the BI monitoring wells. Samples from the on-site water supply well are designated MW-5, consistent with the historic DEQ site groundwater sample location designation. 1.3.6 Adjacent Properties In 1997, the County purchased 58.3 acres of cropland adjacent to the Willamette River, which was part of the Brown’s Island Demolition Landfill Property acquired from Robert Trussell. The eastern portion of this area is shown on Figure 2 as the area with topographic contours between the landfill and the river. The land had been farmed for many years without cause for concern. Seasonal flooding of the Willamette River resulted in severe erosion of the 1-4 March 18, 2013 │ 275-2063-007 Environmental Monitoring Plan Browns Island Landfill Marion County Marion County Department of Public Works riverbank and farmland that raised several concerns including the loss of topsoil, sediment and nutrient pollution from agricultural operations adjacent to the river, stability of the river bank, and potential impact to the closed municipal solid waste landfill. Investigation into these concerns led the Marion County to the Conservation Reserve Enhancement Program (CREP). The U.S. Department of Agriculture’s Farm Service Agency Commodity Credit Corporation (CCC) and the State of Oregon agreed to implement a voluntary CREP at the site to improve water quality of streams providing habitat for nine salmon and two trout species listed under the Federal Endangered Species Act. CREP is designed to encourage and assist landowners to voluntarily plant long lasting areas of ground cover (trees and shrubs – riparian buffer) on environmentally sensitive cropland. In return for participation in the program, landowners receive annual rental payments and cost-share assistance for the planting. Under CREP, Marion County entered into a 15-year contract with the CCC and the State of Oregon. The CREP project initiated by Marion County in 2000 occurred on county land located between the western portion of BI and the Willamette River. This area has become part of the county park system known as Eola Bend Park. This approximately 60 acre area was planted with over 45,000 native plants that serve to control erosion, reduce flood damage, and provide wildlife habitat along the river. On City of Salem property adjacent to the eastern portion of BI is the western portion of the Minto-Brown Island Park. In recent years the City through CREP planted over 5,000 native trees to create a 200-foot buffer along the sloughs and river banks within the Minto-Brown Island Park. Year around footpaths have been established in both parks. The locations of both parks are shown on Figure 3. The Minto-Browns Island Park includes approximately 286 acres of cropland; approximately 107 acres borders the eastern portion of BI (Figure 3). In 2010, the City entered into a floodplain easement agreement with the U.S. Department of Agriculture Resources Conservation Services to remove approximately 166 acres of cropland. The easement areas are to be restored to a more natural native condition. Initial restoration work began in 2010 with planting of various types of native trees and shrubs. The cropland (farm field) located southwest of the western portion of BI is located outside the park complex and is still used an active agriculture field. In 2012, a backflow channel or initial expansion cell associated with the aggregate operation located west of BI facility was excavated along the south side of the farm field that is adjacent to the western corner of BI. Commercial Redimix Aggregate, Inc. operates an aggregate quarry west of BI in the area shown on Figure 3. High quality sand and gravel deposits are extracted by surface mining to produce material for various aggregate-related construction needs. Present operation consists of extracting gravel, sizing the crushed rock, and cleaning sand and gravel for concrete. The facility is permitted by the Department of Geology and Mineral Industries under operating permit aggregate identification number 24-0010. The current disturbed area of the facility is identified to be 115 acres with a total permitted area of 287 acres. As described in a 1997 aggregate expansion plan for the facility, the proposed long term plan for the facility is to continue extraction, processing, and distribution of aggregate products ultimately creating a lake which will be up to 150 surface acres in size. According to the facility’s 1997 Eola Point Project description, the lake and a portion of the surrounding property will be incrementally dedicated to the public as an undeveloped regional park and recreation site. 1.3.7 Site Monitoring Groundwater quality conditions at the BI site have been monitored through a network of monitoring wells since 1974. The location of these wells is shown on Figures 2 and 3. The March 18, 2013 │ 275-2063-007 1-5 Environmental Monitoring Plan Browns Island Landfill Marion County Marion County Department of Public Works wells are sampled on a semi-annual basis. Site monitoring activities and findings are discussed in Section 2. 1.4 GEOLOGIC AND HYDROGEOLOGIC CONDITIONS Geologic and hydrogeologic conditions at the site are described in the BI GQAR Update (Parametrix 1998). The geology at the site can be characterized as young river terrace deposits consisting of stratified sands with well-rounded pebbles, gravels, and cobbles. Underlying the young alluvium deposits is an older marine sedimentary rock unit consisting of tuffaceous siltstone and sandstone. Groundwater flow at the site is primarily toward the northeast with the Willamette River functioning as a discharge or a recharge boundary dependent upon river stage. The base of the uppermost aquifer at the site is at the top of the older marine sedimentary rock unit. 1.4.1 Geologic Conditions There are two distinct geologic units that underlie the site. These units are the recent river alluvium deposits and Eocene-Oligocene sedimentary rock. The recent river alluvium consists of Quaternary (Holocene) age deposits from the Willamette River. The unit consists of stratified sands with well-rounded pebbles, gravel, and cobbles. The upper 15 feet of the unit generally consists of light brown sand and silt overburden material. The lower terrace deposits, which may be present in the lower portion of the alluvium unit, consist of unconsolidated to semi-consolidated cobbles and gravel with sand, silt, and clay. Underlying the river alluvium deposit is an Eocene-Oligocene sedimentary rock unit consisting of tuffaceous siltstone and sandstone of marine depositional origin. On-site well logs describe the unit as consisting of sandstone, silty sand, sandy clay, or blue clayey silt and clay. At the site, the unit has been encountered at depths ranging from 27 to 55 feet below ground surface (bgs). The Columbia River Basalt Group (CRBG) flows that are present northwest and southeast of the site overlie this sedimentary rock unit. However, at the site, the CRBG flows have been eroded away by the Willamette River. No known CRBG flow remnants are present at the site. Based on well logs, the elevation of the top of the sedimentary rock unit appears to be highest in the central area of the landfill and slopes downward toward the Willamette River. Since the surface elevation is fairly consistent in the unfilled area of the site, the thickness of the recent alluvium appears to increase from the landfill to the river. 1.4.2 Hydrogeologic Conditions There are two hydrogeologic units present at the site corresponding with the two geologic units. The uppermost aquifer is present in the river alluvium deposit. Water-bearing zones are also present in the deeper marine sedimentary rock unit. The hydrogeologic conditions of these two units are described below. Figure 4 presents a north/south oriented cross-section of the site showing the two hydrogeologic units at the site. 1.4.2.1 Alluvium The uppermost aquifer is present in the river alluvium with groundwater depths generally ranging from 8 to 18 feet bgs with an average depth of approximately 14 feet bgs. The uppermost aquifer is bounded on all sides by hydraulic boundaries in the form of surface water bodies. The Willamette River forms a boundary on the north and west sides of the site 1-6 March 18, 2013 │ 275-2063-007 Environmental Monitoring Plan Browns Island Landfill Marion County Marion County Department of Public Works and the slough system forms boundaries on the south and east sides of the site (Figure 1). The water elevation of slough system has been observed to be predominantly higher than the Willamette River (Parametrix 1998). A small spill dam located at the east slough’s confluence with the Willamette River helps to maintain a higher slough stage. The direction of groundwater flow in the uppermost aquifer is predominantly toward the Willamette River. Groundwater flow direction reversals (i.e., flow away from the river) have been observed to occur during periods of high river stage conditions (Parametrix 1998). The Willamette River functions as a losing or gaining stream in the site area dependent upon river stage conditions. In general, changes in river stage level correlate with changes in groundwater elevations measured at the site. Changes in river stage influence the gradient of the alluvial groundwater system (i.e., a rising river stage will decrease the groundwater flux to the river causing a flatter groundwater gradient). Slug tests were performed on wells MW-8b/c, MW-12a/b, MW-16, and MW-17 on June 16, 1999. Both falling and rising head tests were completed on each well. Well response was recorded using a pressure transducer and data logger. In general, well response to the inclusion or removal of the slug was quick. The average horizontal hydraulic conductivity for rising head was 3.3E-02 cm/sec (93.4 ft/day). The average horizontal hydraulic conductivity for falling head was 3.9E-02 cm/sec (110.4 ft/day). Slug test activities and analysis were presented in an August 23, 1999, memorandum to the DEQ. As depicted in Figure 4, the saturated thickness of the alluvium aquifer generally increases from the landfill toward the river. As mentioned in Section 1.4.1, this is due to the apparent decreasing elevation of the top of the sedimentary bedrock unit. The area of greatest saturated thickness appears to be in the area of wells MW-12a/b. An increase in saturated thickness represents an increase in the transmissivity of the aquifer. Given the understood hydrogeologic conditions of the site, it appears that the greatest volume of groundwater flowing away from the landfill is moving in the area between wells MW-12a/b and MW-8a/b/c (Parametrix 1998). 1.4.2.2 Marine Bedrock There are water-bearing zones present in the underlying Tertiary marine sedimentary bedrock unit. Regionally, water-bearing zones present in this bedrock unit have been observed to be confined with vertical upward gradients (Woodward 1998). Tertiary sedimentary units in the Willamette Valley commonly produce saline waters (Woodward 1998) that yield only small quantities of water that may be highly mineralized (Foxworthy 1970). The direction of groundwater flow in this unit is not known but the Willamette River in the site area would appear to function as a local area discharge point. March 18, 2013 │ 275-2063-007 1-7 Environmental Monitoring Plan Browns Island Landfill Marion County Marion County Department of Public Works 2. SITE MONITORING BACKGROUND This section presents background information on the environmental monitoring network established at the site. The network consists of groundwater quality monitoring wells and groundwater level measurement points. Groundwater quality monitoring at the site has been conducted on a semi-annual basis since May 1974. This section describes the existing site groundwater quality monitoring well network and water quality conditions. 2.1 MONITORING WELL NETWORK Figure 2 shows the locations of active, nonactive, and decomissioned wells at the site. Summary data for both active and nonactive wells are presented in Table 1. Table 1 also identifies abandoned wells. Appendix B contains copies of the monitoring well logs. Based on the current understanding of site hydrogeologic conditions, the functionality and integrity of the BI monitoring well network is considered good for monitoring groundwater quality conditions at the site. An evaluation of the monitoring well network was completed in 1997 (Parametrix 1997a). The evaluation led to an upgrade effort on several of the older wells (Parametrix 1997b). Documents and correspondence associated with the 1997 monitoring well evaluation and upgrades can be found in Appendix B. All wells at the site are secure, protected, and surveyed. The SAP (Attachment A) describes the procedure that will be used to routinely evaluate and maintain the integrity of all monitoring points at the site. Section 3 describes in further detail how groundwater quality conditions at the BI will be monitored using the existing monitoring well network. 2.1.1 Network Development The first monitoring wells at the site were installed in 1973 and additional wells have been installed over time as the site’s groundwater monitoring program has been modified and adjusted. There have been five phases of well installations at the site. These well installation phases are: • Phase I (May 1973) wells: MW-1a/b/c, MW-2a/b, MW-4a/b/c, and MW-6a/b/c. Wells MW-3 and MW-5 were existing water supply wells. Wells MW-2a/b and MW-6a/b/c were installed in existing supply wells. • Phase II (October 1975) wells: MW-7a/b and MW-8a/b/c. • Phase III (May/June 1979) wells: MW-9a/b, MW-10a/b/c, MW-11a/b, and MW-12a/b. • Phase IV (October 1986) wells: MW-13, MW-14, and MW-15. • Phase V (November 1998) wells MW-16 and MW-17. Wells installed prior to 1980 were completed as single, double, or triple installations. The 1997 Monitoring Well Evaluation Plan (Parametrix 1997a) presents additional monitoring well network information in association with a plan that was used to address well suitability issues. The 1997 Monitoring Well Upgrade Report (Parametrix 1997b) describes the upgrades completed to the site monitoring well network. 2- March 18, 2013 │ 275-2063-007 Environmental Monitoring Plan Browns Island Landfill Marion County Marion County Department of Public Works 2.1.2 Completion Depths Monitoring wells at the site have generally been completed at three different depths or zones in the uppermost aquifer as identified below: • Shallow wells: MW-9b, MW-10a*, MW-6a*, MW-2a*, MW-8a, and MW-7a*. The screen intervals for these wells are above elevation 110 feet. • Intermediate wells: MW-10c, MW-15, MW-6b*, MW-12a, MW-1a*, MW-8b, MW-7b*, MW-13*, and MW-14*. The screen intervals for these wells are generally located between elevations 100 feet and 110 feet. • Deep wells: MW-9a, MW-10b, MW-6c*, MW-12b, MW-1b*, MW-1c*, MW-2b*, MW-8c, MW-16, and MW-17. The screen intervals for these wells are generally below elevation 100 feet. Several monitoring wells have also been completed in the underlying marine sedimentary rock unit. Wells included in this group are: • Sedimentary rock wells: MW-6c*, MW-5, MW-1b*, and MW-1c*. Wells with an asterisk indicate that the well is an inactive water quality monitoring point. All inactive wells are used as piezometers to provide additional information on groundwater flow characteristics at the site. Figure 5 presents a cross-section showing well depths across the site with respect to elevation. Well MW-5 is the on-site water supply well and formerly known as the Trussell well and briefly identified as well W-1. The DEQ Laboratory identified this well as MW-5 in their site monitoring program. 2.1.3 Background Monitoring Well MW-15 functions as the up-gradient background well for the site. However, during temporary groundwater flow reversals that can occur during high river stage events, MW-15 become a down-gradient well. Wells MW-9a/b are located cross-gradient (with respect to groundwater flow) of the landfill and historically have similar water quality concentrations as well MW-15. The 1998 GQAR Update included a limited parameter statistical comparison of wells MW-15 and MW-9a/b. This analysis found that use of wells MW-9a/b as supplemental background water quality monitoring locations was not statistically supported. Given the occurrence of groundwater flow reversals at the site, use of wells MW-9a/b as supplemental background monitoring points may still be justified. However, recent aggregate mining activities occurring just south of MW-9a/b, as discussed in Section 1.3.6, will likely cause geochemical changes to occur at this well pair. 2.1.4 Network Adjustments Since completion of the 1996 BI EMP, inactive monitoring wells MW-11a/b were abandoned during September 1997 due to erosion of the river bank where they were located. Well group MW-4a/b/c was discovered during construction of the new compost facility during 1999. The MW-4 well nest was abandoned shortly afterward in August 1999. As recommended in the 1998 GQAR Update, cross-gradient monitoring wells MW-13 and MW-14 became inactive monitoring points following the spring 1998 event and two new deep replacement monitoring wells MW-16 and MW-17 were installed in November 1998. Inactive wells MW-13 and MW-14 are used as piezometers. March 18, 2013 │ 275-2063-007 2- Environmental Monitoring Plan Browns Island Landfill Marion County Marion County Department of Public Works The 1999 AWQMR presented a request to switch shallow well MW-10a with adjacent inactive intermediate well MW-10c. The switch was requested due to shallow well MW-10a not being able to provide water samples year around and yielding turbid samples when water was available. The DEQ approved this request in a letter dated April 27, 2000. 2.1.5 Well Survey All wells at the site were surveyed during February 2008 by the county. This survey updated the 1998 completed by David Evans and Associates. The 2008 survey included determining the vertical elevations of the water level measurement point (i.e., top of the well PVC) and the top of the aluminum monument caps. Aluminum cap survey monuments were installed next to each well location as part of the 1998 well survey. Elevations are in NAVD88 units and northing/easting coordinates are NAD83 units. The 2008 survey top of the PVC water level measurement point elevations are presented on Table 1. 2.2 GROUNDWATER QUALITY This section presents a review of historic and recent groundwater quality data from the site. Review of historical water quality data has indicated that groundwater quality conditions at the site are seasonally variable. The concentrations of water quality parameters are typically higher during the fall event and lower during the spring event. This seasonal variation of groundwater quality is understood to be caused by Willamette River interaction with the uppermost aquifer at the site. During the spring, the river stage is typically high as a result of the wet winter season and spring runoff events, which effectively recharge the aquifer to some extent. During the fall a low river stage has been established for several months in response to dry summer conditions and as a result discharge to the river from the uppermost aquifer has been established. Due to these conditions, groundwater quality conditions at the site can vary substantially between spring and fall events, especially in wells located closest to the river. Groundwater quality samples at the site have been collected and analyzed on a semi-annual basis since 1974. Table 2 identifies which wells at the site have been sampled 1974 to 2000. Wells indicated as sampled in 2000 are the same wells sampled from 2001 thru 2012. The following water quality standards are typically exceeded in groundwater samples collected from the site monitoring well network: • OAR 340-80 Table 3 Guidance Levels or the EPA secondary drinking water standards associated with manganese, iron, and total dissolved solids (TDS). These aesthetic based standards have been exceeded at the site the past four years (2009 through 2013) typically occurring at the following locations: TDS (wells MW-8a/b/c and MW-12a/b), manganese (all wells except MW-9b and MW-15), and iron (all wells except MW-8a/c, MW-9a/b, and MW-15). • Nitrate has been detected several times in shallow well MW-9b and almost consistently in fall event samples from MW-8s above the OAR 340-80 Table 1 Reference Level, EPA primary drinking water standard associated with nitrate. The PSCL for nitrate, equal to the Primary Drinking Water Standard for nitrate, is also exceeded. The exceedance of manganese, iron, and TDS Guidance Levels has been reported in past annual environmental monitoring reports. 2- March 18, 2013 │ 275-2063-007 Environmental Monitoring Plan Browns Island Landfill Marion County Marion County Department of Public Works The exceedance of nitrate Reference Level and PSCL at well MW-8a has been previously reported. The source of nitrate being detected at MW-8a was investigated as reported in the 2007 and 2008 BI AWQMR. Appendix E contains activities and findings presented in these two reports. As noted in the 2012 AWQMR, nitrate is regularly detected above its primary standard at well MW-8a in fall event samples (14 times in the past 16 years). Elevated nitrate concentrations have also been observed in up-gradient well MW-15 and in cross-gradient wells MW-9a/b. In a July 17, 2009 letter, the DEQ concluded that nitrogen compounds do not appear to be adversely affecting the beneficial uses of groundwater. 2.2.1 GQAR Findings The March 28, 1996, GQAR presented an analysis of groundwater quality data collected from the monitoring well network for the period of April 1985 to March 1995. This time period was selected to evaluate the change in groundwater quality characteristics at the site since closure occurred in 1986. The 1996 GQAR noted that some landfill indicator parameters are higher in wells downgradient (north and northeast) of the landfill than in background well MW-15, including: specific conductance, alkalinity, hardness, dissolved iron, dissolved manganese, sulfate, chemical oxygen demand (COD), and total organic carbon (TOC). Wells that were identified as having elevated indicator parameters were MW-8a/b/c, MW-10a/b/c, and MW-12a/b. The GQAR noted that some downward trends are apparent on the time-series plots for some of the parameters in these down-gradient wells, suggesting that closure activities are beginning to reduce leachate generation and subsequent groundwater quality impacts. In the DEQ's letter review of the GQAR, the current and/or past exceedances of water quality standards were identified as; TDS, iron, manganese, sulfate, total coliform, total cadmium, and total lead at the compliance boundary. 2.2.2 GQAR Update Findings The GQAR Update presented a non-parametric trend analysis (Sen’s slope estimator) used to determine whether the concentrations of six indicator parameters (alkalinity, specific conductance, COD, manganese, chloride, and sulfate) were increasing, decreasing, or remaining the same at both active and inactive well locations. Analysis completed on the active wells found that: 1. Upward trends were occurring primarily at down-gradient well MW-12b, to a lesser extent at shallow well MW-12a; and at background well MW-15 with the exception of chemical oxygen demand (COD) (no change) and manganese (down-ward). 2. Downward trends were occurring primarily in down-gradient wells MW-8a/b/c with the exception of sulfate and at well MW-5 (former Trussell supply well) also with the exception of sulfate. An explanation for the observed upward trends at wells MW-12a/b and downward trends at wells MW-8a/b/c was that: 1. The more westerly wells MW-12a/b are detecting impacts from the more recent use of the western landfill area; 2. The more easterly wells MW-8a/b/c are detecting impacts from the older eastern landfill area. March 18, 2013 │ 275-2063-007 2- Environmental Monitoring Plan Browns Island Landfill Marion County Marion County Department of Public Works 2.2.3 Annual Monitoring Report Findings Recent annual water quality monitoring reports for BI have noted the following groundwater quality conditions at the site. • Examination of recent trends generally indicates site-wide stable or declining concentrations. Wells MW-12b, and to a lesser extent MW-10c, appear to be showing an overall upward trend while wells MW-8b, MW-12a, MW-16, and MW-17 appear to be showing an overall downward trend. The remaining wells are showing either an overall stable trend or no clear overall upward or downward trend. • Wells MW-8c, MW-10b/c, MW-12a/b, and MW-17 show the greatest indications of water quality impact. These wells are located between the landfill and the river. Some of the highest parameter concentrations are being detected at wells MW-12a/b followed by wells MW-17 and MW-8c. A sustained decreasing concentration trend is occurring at well MW-8c. In general, the greatest impacts are observed in wells completed near the base of the uppermost aquifer down-gradient of the landfill. • Observed groundwater quality impacts at the site are primary in the form of ions; specifically calcium, magnesium, bicarbonate, and to a lesser extent chloride, sulfate, iron, and manganese. The highest trace metal concentrations are generally observed at locations where high ion concentrations are also observed (wells MW-8a/b/c, MW-10c, and MW-12a/b). • Recent trace metals results indicate that four (barium, cobalt, nickel, and arsenic) of the nine metals analyzed were detected above the reporting limit in more than 50 percent of the monitoring wells sampled. Selenium and silver were not detected and cadmium was detected in one sample at the reporting limit. The detection frequency of chromium and lead was less than 40 percent. Trace metals were most commonly detected in well MW-9a and MW-10b followed by wells MW-8c, MW-12a/b, and MW-17. The highest concentrations were detected at wells MW-12a/b followed by wells MW-8b and MW-10b. Examination of trends for the four higher frequency detected trace metals found an overall declining concentration trend. Notable concentration increases recently observed in well MW-9a may be related to the recent excavation associated with aggregate mining occurring up-gradient of the well. • The deep wells (MW-8c, MW-10b, MW-12b, and MW-17) are showing the greatest water quality impacts. The shallower portion of the uppermost aquifer has the greatest water quality changes due to apparent river recharge/discharge interaction. Groundwater quality impacts at the BI site are being observed primarily at down-gradient well groups MW-12, MW-10, and MW-8. More limited data is available for newer wells MW-16 and MW-17. Concentrations at well MW-16 are generally lower than at well MW-17. These two newer wells were installed to further delineate and characterize the groundwater quality impacts occurring north of the landfill. 2.2.4 Organic Constituent Detections A review of historical data indicates that volatile organic constituents (VOCs) have been detected at several wells at the site. VOCs have historically been detected at the following well locations: 2- March 18, 2013 │ 275-2063-007 Environmental Monitoring Plan Browns Island Landfill Marion County Marion County Department of Public Works Location Historic Volatile Organic Compound Detections MW-8a Toluene 0.0018 mg/l (10/20/93), 0.00561 mg/l (9/2/98). MW-8b Toluene 0.0010 mg/l (10/20/93), xylenes 0.0015 mg/l (10/20/93). MW-10a Chlorobenzene 0.0026 mg/l (10/20/93) MW-12a Chlorobenzene 0.001 mg/l (10/4/89), 0.0015 mg/l (10/20/93), 0.008 mg/l (10/13/96); 1,4-dichlorobenzene 0.001 mg/l (10/4/89), 0.0025 mg/l (10/20/93), 0.00138 mg/l (9/2/98); 1,3-dichlorobenzene 0.008 mg/l (9/6/90); metyhlene methylene chloride 0.011 (10/13/96) MW-12b Chlorobenzene 0.001 mg/l (10/4/89), 0.0009 (10/20/93), 0.0009 mg/l (10/13/96), 0.00211 mg/l (9/13/00); 1,4-dichlorobenzene 0.001 mg/l (10/4/89), 0.0007 mg/l (10/20/93), 0.0006 mg/l (10/13/96), 0.00149; 1,3dichlorobenzene 0.001 mg/l (9/6/90) MW-13 Methylene Chloride 0.017 mg/l (10/13/96) MW-17 1,4-dichlorobenzene 0.00073 mg/l (9/13/00) Methylene chloride detected in the fall 1996 samples from wells MW-12a and MW-13 was noted in the laboratory analytical report as a possible laboratory contaminant. The tentatively identified compound (TIC) tetrahydrofuran has been detected in well MW-12b in samples collected on 9/2/98 (0.00388 mg/l) and on 9/6/00 (0.0024 mg/l). VOCs have historically been detected in wells MW-12a/b and MW-8a/b. More recent sampling found that the 1,4-dichlorobenzene detected in wells MW-12a/b is also present in well MW-17. More recent analysis for VOCs was completed during the fall 2010 and fall 2012 monitoring events. The results of these analyses are presented in the BI 2010 and 2012 Annual Water Quality Monitoring Reports. Chlorobenzene is typically detected at low concentrations at wells MW-8b and MW-12a/b. Toluene is typically detected at a low concentration at well MW-8a. The compound 1,4-dichlorobenze, which historically was being detected at a decreasing number of locations over time, was not detected in during the fall 2012 event. The greatest number of VOCs (including tentatively identified compounds [TICs]) tends to be detected in the samples from wells MW-12a/b. Analysis of semi-volatile organic compounds (semi-vols), by EPA Method 8270, was completed on a bi-annual basis from 1996 to 2004. During this period, semi-vols had historically been detected at the following well locations. Location Historic Semi-Volatile Organic Compound Detections MW-8a Di-n-octylphthalate 0.006 mg/l (10/13/96); bis(2-ethylhexyl)phthalate 0.0152 mg/l (9/2/98) MW-8b Di-n-octylphthalate 0.006 mg/l (10/13/96) MW-8c Di-n-octylphthalate 0.0091 mg/l (10/13/96) MW-9a Di-n-octylphthalate 0.007 mg/l (10/13/96) MW-9b Bis(2-ethylhexyl)phthalate 0.0162 mg/l (9/6/00) MW-12a Chlorobenzene 0.008 mg/l (10/13/96); di-n-octylphthalate 0.007 mg/l (10/13/96) MW-12b Bis(2-ethylhexyl)phthalate 0.0257 mg/l (9/2/98) MW-14 Bis(2-ethylhexyl)adipate 0.011 mg/l (10/13/96), di-n-octylphthalate 0.012 mg/l (10/13/96), MW-15 bis(2-ethylhexyl)adipate 0.003 mg/l (10/13/96), di-n-octylphthalate 0.006 mg/l (10/13/96) March 18, 2013 │ 275-2063-007 2- Environmental Monitoring Plan Browns Island Landfill Marion County Marion County Department of Public Works During the fall 1998 sampling event, bis(2-ethylhexyl)phthalate was detected at wells MW-8a and MW-12b. Bis(2-ethylhexyl)phthalate is a synonym for dioctyl phthalate (and chemically similar to di-n-octylphthalate), which is used as a plasticizer and may represent possible laboratory contamination (i.e., tubing) or degradation of the PVC well casing. Bis(2ethylhexyl)phthalate was also detected by the DEQ Laboratory in every sample that they collected from the site during the fall 1998 split sampling event including their transfer and transport blanks. The DEQ did not collect a sample from well MW-9b during that event. During the fall 2000 sampling event, several unknown compounds were detected primarily in well MW-12a. The laboratory reported the TICs as unknown compounds because poor correlation existed with associating them to any specific compound names. Further examination of the above unknown TICs by the laboratory identified them as long-chain hydrocarbons from a non-petroleum source. There were also several more peaks present but at levels below the mrl. In essence the semi-vol TIC detections may represent breakdown products of potentially naturally occurring long-chain hydrocarbon compounds. None of the VOCs or semi-vols detected at the site has exceeded a DEQ Numerical Groundwater Standard or an EPA Primary Drinking Water Quality Standard. 2.2.5 River Water Quality The 1998 GQAR Update included an analysis of groundwater discharge into the Willamette River. Groundwater discharge rates into the river were found to be negligible (less than one gallon per day) due to equilibrium conditions that exist between the surface water and the river alluvium deposit groundwater system. The results of the June 1999 slug test further supported the 1998 analysis conclusions. An estimate of chemical loading to the river was also examined in the GQAR Update using the principle of mass balance. This analysis indicated that when considering worst-case conditions (low river stage, high groundwater discharge rate), no measurable increase in the water quality parameters is observed down river of the landfill. This is due to the high river flow volume compared with the rate of groundwater discharged from the site. In an attempt to confirm the chemical loading analysis findings, samples of the river up and down-stream of the site were collected during the fall 2000 event river when river stage conditions are lowest and groundwater discharge to the river is greatest. Examination of the results of fall 2000 river samples indicate that the concentration of the various parameters analyzed are similar at the two locations sampled. The most notable difference were bacteria results where the up-stream river sample location had higher reported enterococcus and total coliform concentrations. Fecal coliform concentrations were similar. The detected concentrations of site-specific parameters such a bicarbonate, chloride, iron, magnesium, and sulfate at the two river sample locations were either the same or very similar. The calcium concentration at the up-stream location was slightly higher than the down-stream sample location. However, the up-stream sample concentration was qualified as an estimated value. The detected total alkalinity concentration was slightly higher in the down-river sample compared with the up-river sample. The field conductivity readings were slightly higher at the down river location whereas the laboratory conductivity reading was slightly higher in the up-stream sample. The results of the fall event sampling of the Willamette River are consistent with the results of the groundwater discharge analysis presented in the BI GQAR Update. In a letter dated March 30, 2001, the DEQ indicated that while the up-stream and down-stream concentrations of inorganic parameter tends to support the no notable difference observation, the estimated values for the bacteria results (their hold times were exceeded) cannot be used as conclusive 2- March 18, 2013 │ 275-2063-007 Environmental Monitoring Plan Browns Island Landfill Marion County Marion County Department of Public Works evidence that groundwater discharge from the site has resulted in no notable impact to the river. March 18, 2013 │ 275-2063-007 2- Environmental Monitoring Plan Browns Island Landfill Marion County Marion County Department of Public Works 3. GROUNDWATER MONITORING PLAN The existing groundwater quality monitoring network at the site consists of 13 groundwater monitoring wells as described in Section 2.1. Historic and recent groundwater conditions at the site were presented in Section 2.2. Based on the information presented in Section 2, a plan for the continued use of these monitoring wells for groundwater quality compliance sampling is presented in this section. The existing site groundwater quality database is described along with procedures that will be used to analyze, review, and report water quality results. Attachment A presents a Sampling and Analysis Plan (SAP) which provides information to guide the collection and analysis of groundwater quality samples at the BI site. The SAP describes the procedures recommended for preparing, obtaining, documenting, preserving, and shipping water quality samples collected at the BI. The SAP establishes Quality Assurance/Quality Control (QA/QC) requirements for sample acquisition and handling at the site. 3.1 GROUNDWATER QUALITY MONITORING POINTS Table 1 identifies the 13 active monitoring wells that will serve as the groundwater quality monitoring network for the site. As shown on Figure 2, wells MW-8a/b/c, MW-12a/b, MW16, and MW-17 are down-gradient compliance boundary wells. Wells MW-9a/b and inactive wells MW-13 and MW-14 are also located on the compliance boundary shown on Figure 2. Potentiometric maps and water quality data indicate that wells MW-9a/b are cross-gradient wells. Potentiometric maps have indicated that wells MW-13 and MW-14 appear to be recharged from the adjacent east slough. The 13 inactive wells will be used as piezometers. Water levels are collected from all 26 wells and used to develop potentiometric maps for the site. All 13 active wells are capable of yielding representative groundwater quality samples from the uppermost aquifer beneath the site. The wells were evaluated for suitability and upgraded in 1997 (see Appendix E). The security casing of each well consists of steel casing with a lock protected access cap. Each well is equipped with a dedicated bladder sampling pump that has been in uses since the fall 2008 event. Dedicated sampling pumps were installed in the 12 active monitoring wells to limit the potential for cross-contamination while increasing sample collection efficiency and representativeness. Prior to the fall 2008 event, the monitoring wells were purged and sampled using a dedicated PVC bailer stored (suspended) in each active well. An exception is sample point MW-5, which is a supply well that is sampled from a tap. All well locations are currently accessible by vehicles using gravel and dirt roads or trails. Section 13.2 of the closure permit indicates that the County shall protect and maintain each groundwater or surface water monitoring well or device so that sample representative of actual conditions can be collected. Any damage discovered shall be reported to the DEQ in writing within 14 days of the discovery, along with a description of the proposed repair or replacement measures and time schedule for completion of repair work. All monitoring well repairs, abandonments, replacements and installations must be documented in a report prepared by an Oregon registered geologist and must be submitted to the DEQ within 30 days of the action and included in the next annual environmental monitoring report. 3-1 March 18, 2013 │ 275-2063-007 Environmental Monitoring Plan Browns Island Landfill Marion County Marion County Department of Public Works 3.2 MONITORING SCHEDULE Section 10.4 of the BI closure permit identifies a semi-annual sampling schedule for environmental monitoring at the site in accordance with the approved EMP. The following compliance sample event periods are identified in the closure permit: • Spring – March 1st through May 31st. • Fall – September 1st through October 31st. During the spring and fall compliance periods, groundwater quality sampling will be completed on the 13 active monitoring wells as identified on Table 3. Table 3 identifies the analytes to be sampled, the sampling frequency and schedule. Table 4 identifies the analytes or parameter included in each parameter group listed in Table 3. As indicated on Table 3, analysis of BI Permit Parameters is completed every two years on even years during fall events (i.e., fall 2014, fall 2016). With the exception of the even year fall events, analysis of BI Indicator Parameters is completed. Table 4 identifies the analytes and parameters associated BI Permit Parameters and BI Indicator Parameters. BI Indicator Parameters were applied beginning with the fall 2011 event. Water level measurement events from all monitoring wells at the site will also be completed during a semi-annual monitoring. 3.3 COMPLIANCE BOUNDARY AND CONCENTRATION LIMITS Permit-specific concentration limits (PSCLs) proposed on October 24, 2003 were approved by the DEQ in a letter dated May 5, 2005. The following PSCLs have been established for the BI site. Contaminant Concentration Limit Arsenic 0.05 mg/l Barium 1.0 mg/l Cadmium 0.0163 mg/l Chromium 0.0469 mg/l Lead 0.05 mg/l Nitrate-N 10.0 mg/l Selenium 0.01 mg/l Silver 0.0140 mg/l The above PSCLs are based on Groundwater Quality Protection Reference Levels (OAR 34040 Table 1) or a site-specific derived concentration. The 1996 BI EMP identified compliance boundary for the site is shown on Figure 2. The GQAR Update indicated that trend analysis using time series plots and Sen’s slope estimator (Gilbert 1987) would be used to periodically to assess the trends in compliance well concentrations. 3.4 REVIEW OF GROUNDWATER QUALITY RESULTS The existing BI groundwater quality database is in Microsoft Access format and includes groundwater quality data, dating back to April 1985. As new site water quality data is obtained, electronic data deliverables (EDDs) from the laboratory are directly uploaded into the database. This database update methodology increases data transfer efficiency and March 18, 2013 │ 275-2063-007 3- Environmental Monitoring Plan Browns Island Landfill Marion County Marion County Department of Public Works reduces data entry errors. Templates and queries have been developed that can provide various types of data reports and formats. The analysis and evaluation of water quality data collected from BI is completed in the following manner. A review of field and laboratory data is initially completed, upon receipt of the data from the laboratory, to identify and address data that: 1) did not meet QA/QC control objectives, 2) represents a significant change in water quality, or 3) exceeds a primary groundwater, drinking water quality standard, or a PSCL. 3.4.1 Routine Event Data Review Action Criteria Section 11.4 of the closure permit indicates that if there is a significant change in water quality, then the County shall notify the DEQ within 10 days of the receipt of the laboratory data. Dependent upon the data review findings, a resampling event may be required as described in this section. The following actions shall be taken based on this data review: • Data indicates there is no significant change (below primary numerical groundwater reference levels, primary drinking water quality standards, or PSCLs: → continue groundwater monitoring with next scheduled event. • Data indicates a significant change in water quality at any monitoring point: → notify the DEQ within 10 days of receipt of laboratory results and perform resampling within 15 days. • Data is above a PSCL: → notify the DEQ within 10 days of receipt of laboratory results and perform resampling within 15 days. Note if this is a known release previously confirmed to the DEQ in writing, then resampling is not required. Examples of a significant change in water quality include: • Detection of a volatile organic constituent (VOC) or other hazardous constituent not detected in the background monitoring point (well MW-15) and previously not reported. • Exceedance of a Table 1 value listed in OAR 340-40-020 unless the background monitoring point (well MW-15) is above these numerical limits and the exceedance has previously been reported. • Exceedance of a primary EPA Primary Drinking Water Standard that has previously not been reported. Note that established permit specific concentration limits and compliance points are listed in Section 3.3. 3.4.2 Resampling Event Data Review Action Criteria As indicated in Section 11.5 of the closure permit, in the case where a routine data review indicates that a resampling event needs to be completed, the data from the resampling event shall be reviewed upon receipt and responded to in the following manner: • If the resampling results do not confirm the routine results, then: 1. Continue with routine monitoring. 3- March 18, 2013 │ 275-2063-007 Environmental Monitoring Plan Browns Island Landfill Marion County Marion County Department of Public Works 2. Discuss the data from the routine sampling event and the resampling event in the next Annual Water Quality Monitoring Report. • If the resampling results confirm that a significant change in water quality has occurred, as noted in the routine results: 1. Notify the DEQ within 10 days of receipt of the laboratory data or within 60 days of the sample date (whichever occurs first). 2. Submit a plan within 30 days (unless another time period is authorized) for developing an assessment program with the DEQ. 3.5 DATA ANALYSIS AND EVALUATION This section describes procedures that will be used to evaluate data quality (data QA/QC) and data analysis using statistical methods. 3.5.1 Data QA/QC A QA/QC review will be completed for each sampling event and will be summarized in a QA/QC summary report that will accompany all data presentation reports. The QA/QC summary report will present the following information: project and sample information; a quality assurance summary; a review of analytical methods and holding times; and a review of laboratory and field quality control samples. Data exclusions from statistical consideration and/or analysis will be identified based on the QA/QC review. Data presentation reports (i.e., Annual Water Quality Monitoring Reports) will also include a review of field activities or observations that may have had an influence on the representativeness of water quality data collected from the site. 3.5.2 Data Presentation and Analysis Water quality data from the site will be tabulated by sample location and parameter. The summary data tables will be organized in a manner consistent with the parameter groups listed on Table 4. Each table will present chemical data for that parameter for each monitoring point in chronological order (i.e., for each sample point the most recent data is presented on the bottom row). Tables organized in this manner facilitate the review and statistical analysis of data. The following formats will be used to present data collected from the BI site, including: potentiometric contour maps, time series plots, trilinear plots, and Stiff diagrams. Note that analysis of BI Indicator Parameters does not allow for development of trilinear plots or Stiff diagrams. The Sen’s slope estimator has been used in the past to evaluate trends in the compliance well data as noted in Section 2.2.2 and represents an accepted DEQ statistics method. EPA’s March 2009 Statistical analysis of Groundwater Monitoring Data at RCRA Facilities Unified Guidance is now considered to provide current recommended and approved statistical analysis methodologies. For trend tests, the Unified Guidance identifies three primary methods: (1) linear regression be used to identify a linear trend and estimate its maganitude; (2) Mann-Kendall test provides a method for identifying trends; and (3) the Theil-Sen trend line method can be used to gauge trend of magnitude. As noted in Section 2.2, groundwater concentrations at BI vary notably over time due seasonal variability and in response to other geochemical changes. As a consequence, time series plots for BI show a lot of variability in groundwater quality data over time. Some of March 18, 2013 │ 275-2063-007 3- Environmental Monitoring Plan Browns Island Landfill Marion County Marion County Department of Public Works this variability is seasonal while some variability does not appear to be seasonally related. The variability at a given well is not necessarily consistent for all parameters or locations or at similar locations but different depths. For example, a well could show a notable concentration increase of ammonia and total dissolved solids while showing, at the same time, a notable decrease in sodium and potassium. An adjacent well screened slightly deeper may show different conditions. The extent of data variability at the site can make it difficult to characterize whether a given parameter is actually increasing or decreasing over time. In response to the presence of notably variable groundwater concentration conditions, review of BI time series plots has consisted of examining short-term plots, consisting of 5 years of most recent data [10 sample data sets], along with review of long-term plots (consisting up to more than 25 years of data) to provide context for the short-term plots. A best fit line using linear regression is applied to the 10 sample data set and used to assist in examining the overall recent linear trend of the data. As needed, summary statistics can also be completed including: sample size, average, median, standard deviation, interquartile range, standardized skewness, standardized kurtosis, and interquartile range of parameter detections. All nondetects will be replaced with a value that is 1/2 of the reported method detection limit (MDL). The summary statistics will be computed using either Microsoft Excel, an Excel statistics add-on package such as Analyzsit, Statgraphics, or a comparable statistical software package. Data evaluation will also include a comprehensive comparison of groundwater quality sample results to the following applicable water quality standard and site-specific concentration limits: • State of Oregon Numerical Groundwater Quality Reference and Guidance Levels (OAR 340-40-020 Tables 1 through 3). • EPA National Primary Drinking Water Regulations. • Permit Specific Concentration Limits listed in Section 3.3. These water quality standards are presented on Table 4. 3.6 REPORTING Reporting of environmental data includes the submittal of Annual Water Quality Monitoring Reports and the results of split-sampling events. These reporting requirements are addressed in this section. 3.6.1 Annual Water Quality Monitoring Report As indicated in Section 12.2 of the closure permit, an Annual Water Quality Monitoring Report (AWQMR) is to be submitted prior to March 15th of each calendar year for the duration of the closure permit. The AWQMR will address environmental monitoring activities, results, and findings from the previous year. Whenever possible, the report needs to be completed as a two-sided document. To reduce physical size of the report and reduce paper usage, report appendices can be presented as electronic files contained on a compact disc attached to the report’s back inside cover page. Two copies of the report, stamped by an Oregon registered geologist or engineering geologist, are to be submitted to the DEQ. The AWQMR is to include a statement of compliance, a one-page cover letter that presents a concise comparison of the analytical results with the monitoring standards identified above in Section 3.5.2. Specifically, the statement of compliance letter will: 3- March 18, 2013 │ 275-2063-007 Environmental Monitoring Plan Browns Island Landfill Marion County Marion County Department of Public Works • Compare the analytical results with the relevant monitoring standards (PSCLs). • State whether or not federal or state standards were exceeded for the relevant media. • State whether or not a significant change in water quality has occurred. Examples of significant change in water quality are provided in Section 3.4.1. As indicated in Section 12.4 of the closure permit, the AWQMR needs to include the following information: • An executive summary. • Site background and recent site activity information. • A summary presentation of all environmental monitoring performed during the past year. • A summary presentation of data validity (i.e., review of holding times, comparison of blanks and duplicates, major cation/anion balance for each groundwater sample collected, identification of data problems or discrepancies, field QA/QC issues, and laboratory compliance with QA/QC standards) and identification of data problems. • Summary tables of all analytical results by sampling location organized by the parameter groups as described in Section 3.5.2. • Itemization of any activities resulting from the exceedance of a relevant standard or significant change in water quality. Examples include resampling events, submittal of a Preliminary Assessment or an Assessment Monitoring Report. • Presentation of water level data and groundwater flow direction using contour maps, tables, and graphs. • Updated time-series plots and other completed statistical analysis as described in Section 3.5.2. • Copies of all field data sheets, laboratory analytical reports, and chain-of-custody documents completed for the year being reported. • Copies of all monitoring well repairs, abandonments, replacements, and installations that occurred at the site during the reported year. • A summary of new or proposed activities at the site. Note that application of the BI Indicator Parameters does not allow for completion of cation/anion balances or the generation of Stiff and Piper diagrams. Copies of the AWQMR are to be submitted to the following address: Oregon Department of Environmental Quality Manager – Western Region Solid Waste Program 750 Front Street NE, Suite 120 Salem, Oregon 97301-1039 3.6.2 DEQ Laboratory Split Sampling Report The BI closure permit does not contain specifies split sampling event dates but indicates in Section 10.3 that spit sampling with DEQ shall occur when requested. If requested, scheduling the event with the DEQ Lab must occur at least 45 days prior to the sampling event. March 18, 2013 │ 275-2063-007 3- Environmental Monitoring Plan Browns Island Landfill Marion County Marion County Department of Public Works In the event of a DEQ split sampling event, the following information will be submitted to the DEQ laboratory, located in Portland, Oregon, within 90 days of the split-sampling event: • Copy of all information pertinent to the sample collection, handling, transport and storage, including field notes. • Site map showing groundwater flow directions and contours. • Copies of all laboratory analytical data, QA/QC reports, and any additional data specifically requested by the DEQ laboratory. The address for the DEQ laboratory is: Oregon Department of Environmental Quality Laboratory Division, Groundwater Monitoring Section 3150 NE 229th Avenue, Suite 150 Hillsboro, Oregon 97124 (503) 693-5700 3.7 REDUCTION IN MONITORING The County may petition for a reduction in the sampling frequency, a reduction in the number of locations to be sampled, or the elimination of selected monitoring parameters for the site environment monitoring program. A demonstration would need to be presented to the DEQ’s satisfaction that, for each monitoring point or parameter in consideration, sufficient samples have been analyzed to allow for adequate assessment of the data. Adequate justification for all proposed reductions in sampling frequency and parameters will need to be provided to the DEQ. 3- March 18, 2013 │ 275-2063-007 Environmental Monitoring Plan Browns Island Landfill Marion County Marion County Department of Public Works 4. REFERENCES American Society for Testing and Materials (ASTM) 1996, Provisional Standard Guide for Developing Appropriate Statistical Approaches for Ground-Water Detection Monitoring Programs. ASTM PS 64-96. Bela, James L. 1981. Geology of the Rickreall, Salem West, Monmouth, and Sidney 7½’ Quadrangles, Marion, Polk, and Linn Counties, Oregon. Issue by State of Oregon Department of Geology and Mineral Industries, Geological Map Series GMS-18. Foxworthy, B.L. 1970. Hydrologic Conditions and Artificial Recharge through a well in the Salem Heights Area of Salem, Oregon: U.S. Geological Survey Water-Supply Paper 1594-F. Oregon Department of Environmental Quality (DEQ). 1996. Solid Waste Guidance Municipal Solid Waste Landfills; September 1, 1996. Updated versions of the guidance document is presented on the DEQ’s homepage (www.deq.state.or.us/wmc/solwaste/swguide/) can also be referenced. Parametrix, Inc. 1996. Environmental Monitoring Plan, Brown’s Island Landfill; prepared for Marion County Department of Solid Waste Management, April 19, 1996. Parametrix, Inc. 1996. Groundwater Quality Assessment Report, Brown’s Island Landfill; prepared for Marion County Department of Solid Waste Management, March 28, 1996. Parametrix, Inc. 1997a. Monitoring Well Evaluation Plan, Brown’s Island Landfill; prepared for Marion County Department of Solid Waste Management, June 16, 1997. Parametrix, Inc. 1997b. Monitoring Well Upgrade Report, Brown’s Island Landfill; prepared for Marion County Department of Solid Waste Management, December 8, 1997. Parametrix, Inc. 1998. Groundwater Quality Assessment Report Update, Brown’s Island Landfill; prepared for Marion County Department of Solid Waste Management, April 13, 1998. Parametrix, Inc. 2001. Environmental Monitoring Plan, Brown’s Island Landfill; prepared for Marion County Department of Solid Waste Management, April 26, 2001 update. Sweet, Edwards & Associates, Inc. 1987. Brown’s Island Landfill, Proposed Waste Boundary Adjustment and Post-Closure Monitoring. Unpublished report prepared for Marion County. U.S Environmental Protection Agency (EPA). 2009. Statistical Analysis of Groundwater Monitoring Data at RCRA Facilities, Unified Guidance, Office of Resource Conservation and Recovery. EPA 530-R-09-007. March 2009. U.S. Environmental Protection Agency, Washington D.C. March 18, 2013 │ 275-2063-007 4- Environmental Monitoring Plan Browns Island Landfill Marion County Marion County Department of Public Works U.S Environmental Protection Agency (EPA). 1993. Solid Waste Disposal Facility Criteria, Technical Manual. EPA 530-R-93-017. U.S. Environmental Protection Agency, Washington D.C. U.S. Environmental Protection Agency (EPA). 1992. Statistical Analysis of Ground-Water Monitoring Data at RCRA Facilities. Addendum to Interim Final Guidance. Office of Solid Waste, Permits and State Programs Division, U.S. EPA, Washington, D.C. U.S Environmental Protection Agency (EPA). 1989. Statistical Analysis of Ground-Water Monitoring Data at RCRA Facilities. Interim Final Guidance. Office of Solid Waste, Waste Management Division, U.S. EPA, Washington, D.C. EPA/530-SW-89-026. U.S Environmental Protection Agency (EPA). 1986. Test methods for evaluating solid waste, 3rd edition, update III. U.S. Environmental Protection Agency. Washington, D.C. Woodward, D.G, Gannett, M. W., and Vaccaro, J.J. 1998. Hydrogeologic Framework of the Willamette Lowland Aquifer System, Oregon and Washington. Regional Aquifer-System Analysis – Puget-Willamette Lowland. U.S. Geological Survey Professional Paper 1424-B. 4-2 March 18, 2013 │ 275-2063-007 Site Location DATE: March 1, 2011 FILE: BrownIsland_SiteLocation.mxd 0 ´ 0.5 Miles Figure 1 Site Location 1 Annual Water Quality Monitoring Report Brown's Island Landfill DATE: Oct 19, 2012 0 400' SCALE IN FEET FILE: PO2063007F-91 Figure 2 Facility Map Annual Water Quality Monitoring Report BROWN'S ISLAND LANFILL MARION COUNTY, OREGON Fa rm Fi eld MW-16 W IL . ! E E oo ll aa B B ee nn dd C C oo uu nn tt yy P P aa rr kk . MW-9a/b ! . MW-12a/b ! L A M E T T E ! MW-10a/b/c . . MW-17 ! Ag gre g at e Q u arry Future Aggregate Extraction Area RI VE R ! . MW-8a/b/c . MW-13 ! MW-6a/b/c ! . Fa rm Fi eld Fa rm Fi eld . ! Fa rm Fi eld MW-5 ! . MW-7a/b Fa rm Fi eld . MW-2a/b ! . MW-1a/b/c ! MW-14 . MW-15 ! . ! . ! East Slough Fa rm Fi eld M M ii nn tt oo -- B B rr oo w w nn II ss ll aa nn dd C C ii tt yy P P aa rr kk Fa rm Fi eld . ! South Slough (Entrance Slough) Sale m Go l f Clu b Fa rm Fi eld Ho me st ead R o ad Br o w n' s Is lan d R .D . 5 Fa rm Fi eld Go lf C o urs e DATE: March 3, 2011 FILE: BrownIsland_AerialSiteMap.mxd 0 ´ 0.25 Miles 0.5 Site Location . ! Monitoring Well Future Aggregate Extraction Area . ! Surface Water Elevation Monitoring Point Recent Excavated Area Park Boundary Figure 3 Aerial Site Map Annual Water Quality Monitoring Report Browns Island Landfill SOUTH NORTH Figure 4 North/South Cross-Section A A' Figure 5 Well Cross-Section A-A' Environmental Monitoring Plan Update Table 1: Monitoring Well Summary Data Sampling and Analysis Plan Browns Island Landfill Active Monitoring Wells Well ID MW-5 MW-8a MW-8b/c MW-9a/b MW-10b/c MW-12a/b MW-15 MW-16 MW-17 Date Installed Well Log 1/5/1969 10/16/1975 10/15/1975 3/76-7/79 3/76-7/79 3/76-7/79 10/31/1986 11/11/1998 11/10/1998 yes yes yes no no no yes yes yes Construction Well Depth (from top Type of PVC - ft) Top of PVC Casing Elevation (ft) Screen Length (ft) Screen interval (ft below top of PVC) supply single double double double double single single single 105 20.47 23.90/37.72 37.08/23.78 33.42/24.70 26.90/43.51 44.36 48.77 42.38 153.84 136.72 136.88/136.62 136.98/137.02 134.78/134.94 136.17/135.83 140.24 141.92 137.81 none 5 3/3 4.0/4.9 1.1/4.8 4.6/4.4 20 10 10 61-105 15.3 - 20.3 23-26/32-35 32.9-36.9/18.8-23.9 32.2-33.3/19.8-24.6 22.2-26.8/39.0-43.4 20-40 36/46 30/40 Construction Type Well Depth (ft) Top of PVC Casing Elevation (ft) Screen Length (ft) Screen interval (ft below top of PVC triple double triple single single single single single 40.67/47.17/51.33 41.75/57.5 33.3/43.33/54.3 22.0 34.3 14.32 43.55 28.25 151.75/152.01/152.16 158.63/158.68 151.89/151.89/151.90 141.36 141.90 134.78 135.31 128.85 2.5/2.5/2.5 2.5/2.5 5/5/4 5 5 4.8 20 5 38.2-40.6/44.7-47.1/48.8-51.3 39.2-41.7/55.0-57.5 28.3-33.3/38.3-43.3/50.3-54.3 15-20 30-35 9.4-14.2 21/41 21/26 Construction Type Well Depth (ft) Date Abandoned triple double 40/48/62 15.08/21.31 7/29/99-8/2/99 9/8/1997 Inactive Monitoring Wells Well ID MW-1a/b/c MW-2a/b MW-6a/b/c MW-7a MW-7b MW-10a MW-13 MW-14 Date Installed Well Log 5/8-5/21/73 5/22-23/73 5/23-5/31/73 10/13/1973 10/8/1973 3/76-7/79 10/29/1986 10/30/1986 yes yes yes yes yes no yes yes Abandoned Monitoring Wells Well ID MW-4a/b/c MW-11a/b 3/20/2013 Date Installed Well Log 4/16-5/7/73 3/76-7/79 yes no Table01_well data sum_2013.xlsx X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X 4/13/1976 X X X 5/24/1976 X X X X X X X X X X X X X X X X X 6/23/1976 X X X X X X X X X X X X X X X X X 7/27/1976 X X X X X X X X X X X X X X X 9/23/1976 X X X X X X X X X 7/11/1977 X X 3/6/1978 X X X 9/18/1978 X X X X 5/21/1979 X X X X 9/10/1979 X X X X 10/7/1980 X X X 5/27/1981 X X X 7/7/1982 X X X 9/22/1982 X X 5/11/1983 X X 9/8/1983 X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X 5/2/1984 X X X X X 10/31/1984 X X X 4/17/1985 X X X X X 11/7/1985 X X X X X 6/3/1986 X X X X X 10/29/1986 12/30/1986 4/22/1987 X X X X X 11/12/1987 X X X X 4/6/1988 9/7/1988 5/2/1989 10/4/1989 X 4/11/1990 4/12/1990 X 9/5/1990 X 9/6/1990 4/18/1991 X 10/8/1991 X 10/9/1991 5/13/1992 5/14/1992 X 6/4/1992 10/5/1992 10/6/1992 X 4/7/1993 4/8/1993 X 10/20/1993 X 4/11/1994 4/12/1994 X 9/13/1994 X 3/7/1995 X 3/27/1996 10/3/1996 X 5/22/1997 X X 9/3/1997 5/28/1998 X 9/2/1998 X 5/26/1999 X 9/21/1999 X 5/31/2000 X 9/13/2000 X NOTES: 9/13/94 data indentified as 9/12/94 data in Storet. Former Trussel water supply well and Well 5 are the same well. - Indicates related events 3/20/2013 X X X X X X X X X X X X X X QA Sample X X X River Down X X X X Well 17 X X X X River Up X X X X Well 16 X X X X Well 15 Well 12B X X X X Well 14 Well 12A X X X X Well 13 Well 11B X X X X Well 11A Well 10B Well 10C X X X X Well 9B X X Well 10A X X X Well 9A X X Well 8B X X Well 8C X X Well 8A X X X Well 7B X 7/9/1975 9/9/1975 X Well 7A 3/10/1975 X Well 6B X X Well 6C X X Well 5 X X Well 6A 12/30/1974 X Well 4B X X Well 4C X X X Well 3 X X X Well 4A X 3/9/1976 Well 2B Well 1B Well 1C 5/2/1974 9/11/1974 WELL ID Well 2A Well 1A TABLE 2: SAMPLE LOCATION SUMMARY - 1994 thru 2000 ENVIRONMENTAL MONITORING PLAN UPDATE BROWNS ISLAND LANDFILL X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X Well 12A Well 12B Well 9B Well 10C X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X SEA Data/No Dup. Well 13A Well 13A Well 15A Well 8B Well 8A Well 5 Well 15C Well 5 Well 5 X X Well 5 & 15 Well 5 Well10B Well 8B Well 5 X X X X X X X X X X X X X X X X X X X X X Well 9B X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X Well 14B Well 10B Well 8A Well 5 Well 5 Well 8C Well 5 Well 15 Well 13A Well 10B Well 12A Well 8C &10B Well 9A &12A Well 5 & 8C Well 12A Well 16 Well 5 X Well 10C X Well 15 Table02_Well Sampling Location Summary.xlsx TABLE 3: WATER QUALITY SAMPLE LOCATIONS, FREQUENCY, AND SCHEDULE ENVIRONMENTAL MONITORING PLAN BROWNS ISLAND LANDFILL Locations Analytes * Alluvium wells: Group 1a Group 1b Group 2a Shallow: MW-8a. Frequency Schedule Semi-annual Spring and Fall Bi-annual Every two years in Fall beginning in 2006 Semi-annual Spring and Fall Bi-annual Every two years in Fall beginning in 2006 Intermediate: MW-8b, MW-9b, MW-10c, MW-12a, and MW-15. Deep: MW-8c, MW-9a, MW-10b, MW-12b, MW-16, and MW-17. Group 2b Group 3 Marine Sedimentary Rock wells: Group 1a Group 1b Group 2a MW-5 (on-site supply well) Group 2b Group 3 Piezometers: Water levels MW-1a/b/c, MW-2a/b, MW-6a/b/c, MW-7a/b, MW-10a, MW-13, and MW-14. Semi-annual: all monitoring wells Spring and Fall NOTES: * See Table 2, Water Quality Monitoring Parameters, for analytes/parameters included in each parameter group. BI Indicator Parameter list is applied except during even year Fall events (i.e., Fall 2012, Fall 2014, etc.) when the BI Permit Parameter list is applied. The semi-annual compliance monitoring periods are: Spring: March 1st through May 31st. Fall: September 1st through October 31st. TABLE 4: WATER QUALITY MONITORING PARAMETERS ENVIRONMENTAL MONITORING PLAN BROWNS ISLAND LANDFILL BI INDICATOR PARAMETERS BI PERMIT PARAMETERS GROUP 1a: FIELD INDICATOR PARAMETERS ELEVATION OF WATER LEVEL ELEVATION OF WATER LEVEL pH pH TEMPERATURE TEMPERATURE SPECIFIC CONDUCTANCE SPECIFIC CONDUCTANCE DISSOLVED OXYGEN DISSOLVED OXYGEN REDOX POTENTIAL (Eh) REDOX POTENTIAL (Eh) GROUP 1b: LABORATORY INDICATOR PARAMETERS HARDNESS (as CaCO3) TOTAL ALKALINITY (as CaCO3) TOTAL ALKALINITY (as CaCO3) TOTAL DISSOLVED SOLIDS (TDS) TOTAL SUSPENDED SOLIDS (TSS) TOTAL DISSOLVED SOLIDS (TDS) TOTAL SUSPENDED SOLIDS (TSS) CHEMICAL OXYGEN DEMAND (COD) TOTAL ORGANIC CARBON (TOC) GROUP 2a: COMMON ANIONS AND CATIONS# CALCIUM (Ca) CALCIUM (Ca) MAGNESIUM (Mg) SODIUM (Na) POTASSIUM (K) IRON (Fe) IRON (Fe) MANGANESE (Mn) MANGANESE (Mn) AMMONIA-NITROGEN (NH3-N) AMMONIA-NITROGEN (NH3-N) BICARBONATE ALKALINITY (HCO3) SULFATE (SO4) SULFATE (SO4) CHLORIDE (Cl) NITRATE (NO3-N) CHLORIDE (Cl) NITRATE (NO3-N) SILICA (Si) GROUP 2b: TRACE METALS ARSENIC (As) BARIUM (Ba) CADMIUM (Cd) CHROMIUM (Cr) COBALT (Co) LEAD (Pb) NICKEL (Ni) SELENIUM (Se) SILVER (Ag) GROUP 3: VOLATILE ORGANIC CONSTITUENTS VOLATILE ORGANIC CONSTITUENTS METHOD REPORTING DEQ REFERENCE LEVEL LEVELSd (mg/L) (mg/L) METHOD METHOD DESCRIPTION FIELD FIELD FIELD FIELD FIELD FIELD Electric Probe Reference Electrode Probe Temperature Probe Conductivity Probe Metal Cathode Probe Platinum Band Sensor Probe 6020a ICP-MS Titrimetric Gravimetric Gravimetric Spectrophotometric UV, Persulfate Oxidation-IR 2.00 10.0 10.0 10.0 5.00 1.00 ICP-MS ICP-MS ICP-MS ICP-MS ICP-MS ICP-MS Electrode Titrimetric Ion Chromotography 0.050 0.002 1.00 1.00 0.0250 0.00200 0.100 10.0 1.00 b 310.1 b 160.1 160.1b 410.4b b 415.1 200.7b 200.7b 200.7b 200.7b 200.7b 200.7b b 350.3 310.1b b Ion Chromotography Ion Chromotography 0.500 0.100 Spectrophotometric Reduction 0.250 6020a 6020a 6020a 6020a 6020a 6020a 6020a 6020a 6020a ICP-MS ICP-MS ICP-MS ICP-MS ICP-MS ICP-MS ICP-MS ICP-MS ICP-MS 0.00100 0.00100 0.00100 0.00200 0.00100 0.00100 0.00200 0.00100 0.00100 8260a Gas Chromotography/Mass Spect 0.50-1.0 ug/L DISSOLVED CONCENTRATIONS. SAMPLES MUST BE FIELD-FILTERED. a TEST METHODS FOR EVALUATING SOLID WASTE - PHYSICAL/CHEMICAL METHODS. 3rd edition. EPA SW-846 (November 1990). b METHODS FOR CHEMICAL ANALYSIS OF WATER AND WASTES. EPA-600/4-79-020 (revised March 1983). d DEQ NUMERICAL GROUNDWATER QUALITY REFERENCE LEVELS (HEALTH BASED). OAR 340-040-080 (January 1990). e DEQ NUMERICAL GROUNDWATER QUALITY GUIDANCE LEVELS (NONHEALTH BASED). OAR 340-040-080 (January 1990). f EPA NATIONAL PRIMARY DRINKING WATER STANDARDS. EPA 816-F-02-013 July 2002. EPA DRINKING WATER f STD (mg/L) 6.5 to 8.5 su 300.0 325.3b b 353.3 370.1b # DEQ GUIDANCE LEVELSe (mg/L) 500 0.3 0.05 250 250 10.0 10 0.05 1.0 0.01 0.05 0.05 2 0.005 0.1 0.05 0.015*** 0.01 0.05 0.05 0.1 *** EPA ACTION LEVELS. ICP-MS: Inductively Coupled Plasma-Mass Spectrometry TRACE METALS - TOTAL CONCENTRATIONS IF TSS <100 mg/L; BOTH TOTAL AND DISSOLVED CONCENTRATIONS IF TSS >100 mg/L. 3/20/2013 Table04_WQ Parameters_indicators.xlsx ATTACHMENT 2 Designated Analytical Laboratory Quality Assurance Program (Please see attached CD) Clarifications & Definitions This document is footnoted to reference applicable sections of the 2003 National Environmental Laboratory Accreditation Conference (NELAC) Standard and the corresponding items on the NELAC 2003 Quality Systems checklist. Element: refers to Apex's laboratory information management system. Element is the brand name of the software marketed by Prōmium. This is an uncontrolled copy of a controlled document. Please check with Apex Labs to ensure that this is the most recent revision of this document. Page 2 of 55 Table of Contents Title Section Page Quality Assurance Policy Statement 1.0 6 2.0 7 3.0 8 4.0 9 5.0 11 6.0 12 7.0 12 8.0 13 Objectives Protocols Responsibilities Laboratory Ethics and Data Integrity Ethics Training Documentation and Tracking Client Services Acceptance of Work Statement of Qualifications Client Communication Complaints Organization & Responsibility Conflict of interest & Employee Roles Organizational Structure Job Descriptions of Key Positions Sample storage, tracking and handling Training Training Protocol New Employee Orientation Ongoing Training Training Files Laboratory Responsibilities Lines of Authority Approved Signatories Independence of QA Facilities, Equipment & Supplies Facilities Equipment Procurement of Supplies Sample Management Page 3 of 55 Analysis Requests Sample Receipt Cooler Receipt Form COC Inconsistencies / Sample Problems Subcontracting of Samples 8.3 14 8.4 15 Environmental Test Method Selection, Validation & Documentation 9.0 15 Policy Reporting Sample Handling Storage Tracking Disposal Method Sources Standard Operating Procedures Method Detection Limits Method Reporting Limits Calibration & Maintenance 10.0 16 11.0 19 Calculations 12.0 24 Data Reduction, Validation, & Reporting 13.0 25 Naming conventions used by Element 14.0 27 Control of Nonconformances and Corrective Action 15.0 27 Instrument Calibration Instrument Maintenance Reference Standards Support Equipment Data Quality Objectives Definitions Criteria Instrument QC Extraction Batch QC Data Reduction & Primary analytical review Secondary data review Tertiary data review and reporting Definitions and Explanation Laboratory & Sample Quality Control Nonconformance Procedural Nonconformance Expected Nonconformance Page 4 of 55 Technical Operations or Quality System Nonconformance Responsibilities & Authority for Nonconforming Work Response Time Assessment of Impact Corrective Actions, Preventative Measures and Follow up Documentation 16.0 32 17.0 35 18.0 36 19.0 37 Analytical Data Analytical Data Storage Supporting Data Storage Quality System Documentation Accessibility Document Control Definitions and Explanation Authorization and Revision Laboratory Policy Process Computer Hardware and Software Validation Backup Performance and System Audits Performance Audits Proficiency Testing Quality System Audits Figures Organizational Chart Floor Plan Chain of Custody Cooler Receipt Form Sample Report Nonconformance Report Form Page 5 of 55 Apex Laboratories, LLC Quality Assurance Manual Rev No 3, 06/30/11 1. Quality Assurance Policy Statement This Quality Assurance (QA) Manual summarizes the overall quality system in place at Apex Laboratories, LLC. The signatures on the front cover serve to document laboratory management's commitment to upholding the tenets of this QA Manual and the related documents that support the quality system.1 The objectives and policies laid out in this manual are issued under the authority of the Laboratory Director, and Apex assumes legal responsibility for compliance with them.2 1.1. The objectives of Apex's quality system are summarized as follows:3 a) Produce data that are scientifically valid, defensible, reproducible, accurate and timely. b) Report data of known quality, representative of the submitted sample and most appropriate to the end-use of the data. c) Provide a framework for effective communication of, and adherence to, all applicable method and regulatory guidelines and client requirements. 4 d) Provide a mechanism for continuous improvement and minimize departures from the quality system. e) Document the means by which the laboratory's quality objectives (items a-d above) are achieved. f) Ensure that personnel uphold the laboratory's quality objectives and are fully empowered to do so.5 1.2. 6The protocols of the laboratory's quality system fall into two categories: (1) those specific to the analytical method sources referenced in section 9.1, and (2) those applicable to the laboratory's operations in general as regulated by the standards of accrediting bodies, including Washington Department of Ecology (WA DOE) and Oregon Environmental Laboratory Accreditation Program (ORLAP). Whichever format presents the most stringent QA/Quality Control (QC) requirements takes precedence, unless specifically excluded.7 a) Analytical procedure and QA/QC requirements specific to an analytical method are included in the laboratory's standard operating procedure (SOP) for the method. An SOP may cover more than one analytical method. b) QA protocols applicable to the laboratory's operations in general are documented as one or more of the following: i The QA Manual - references further detailed documentation when applicable and copies may be footnoted to reference the 2003 National Environmental Laboratory Accreditation Conference (NELAC) Standard. ii Apex SOPs - categorized by department, including QA administrative SOPs. iii Laboratory Policies – address issues applicable to multiple SOPs, usually short enough to not warrant being a full SOP. 1.3. 8It is the QA Department's duty, with the support of the rest of the management team, to integrate the quality system into the daily operations of the laboratory. Requirements of the quality systems are informally communicated through the normal day-to-day interactions of laboratory status and department meetings, data review, training, addressing analytical problems, etc. For Apex, it is imperative that the quality system is the framework of the laboratory's function, not a separate aspect of it. Formal periodic Page 6 of 55 Apex Laboratories, LLC Quality Assurance Manual Rev No 3, 06/30/11 documentation of each employee's knowledge of the aspects of the quality system relevant to their job and their agreement to implement them is achieved by the following: a) Each employee reads the QA Manual as part of their initial orientation, and each new revision of it thereafter. b) A training session on the QA Manual and relevant QA SOPs and policies is given by a member of the QA department at least once a year. c) New policies are communicated via email and are made available electronically. d) Analysts review their method SOPs against current published methods annually. 2. Laboratory Ethics and Data Integrity9 Apex Laboratories, LLC, has an internal program in place to create an ethically sound culture and ensure data integrity. Apex’s ethics program is described in detail in Apex SOP Q-101 Code of Ethics. 2.1. Ethics Training Apex's ethics program is supported by many components of the quality system and includes annual ethics training for all employees that covers: a) Detection, evaluation and remediation of any improper, unethical or illegal actions. b) Management's responsibility to provide personnel with the resources and authority to carry out their work in accordance with the quality system and ethics program. c) Prevention of any undue pressures or influences (internal or external) that may adversely affect the quality of work. 10 d) The agreement of personnel, and the laboratory as a whole, to not participate in any business or activity that could:11 i Pose a conflict of interest, ii Compromise the integrity of the data generated by the laboratory or client confidentiality, or iii Undermine the laboratory's compliance with safety and/or hazardous waste disposal regulations. e) Each new employee receives ethics training as part of their orientation. A signed ethics agreement is kept in each employees training file. Lab-wide refresher training for the ethics program is given annually by the QA department. This training is documented by dated signatures of those attending the training session. Training signature sheets are kept on file in the QA department. 2.2. Documentation and Tracking Data integrity issues are documented in order to track any further investigation or follow-up that may be required and to provide a historical record in case of further incidents. a) Documentation may include: i Data review or internal audit findings and subsequent corrective action, Page 7 of 55 Apex Laboratories, LLC Quality Assurance Manual Rev No 3, 06/30/11 ii A non-conformance report with subsequent corrective action, or iii In cases where confidentiality is an issue, and/or the ethical concern is not directly associated with any specific data, documentation as a Code of Ethics Non-Conformance Report may be kept by human resources in the appropriate personnel file. b) In order to track the occurrence of data integrity and/or ethical concern issues for periodic assessment of the Quality System, (the annual QA Report to Management, etc), the QA department keeps a record of all Code of Ethics Non-Conformance Reports kept in personnel files. c) Apex maintains that the greatest deterrent for inappropriate action is a corporate climate of personal accountability and commitment to the highest degree of integrity in all actions of the laboratory and its staff members. 3. Client Services 3.1. Acceptance of Work12 - The Project Manager is responsible for reviewing the technical and service requirements of any request to provide analytical testing prior to accepting the work. This includes a review of the capacity and capability of each department involved, taking into consideration factors such as laboratory accreditation, instrumentation, methodology, staffing, turn around times, reporting levels and specialized project requirements. The laboratory will not accept samples for in-house analysis where capability or capacity is exceeded. a) A client's request for work is documented, at a minimum, by a submitted chain of custody (COC) and may be include further documentation such as a Quality Assurance Project Plan (QAPP) or Sampling and Analysis Plan (SAP) from the client. b) Apex makes every effort to clarify and document project requirements and provide the most appropriate analytical support: i If impropriety of sample handling or sample containers is significant enough to potentially compromise data integrity, the client is notified for the option of re-sampling or qualification of the data. ii If samples are of an atypical matrix, Apex has a protocol in place to ensure appropriate sample preparation and analytical methods are applied and thoroughly documented. iii Any incongruities between a client's request for work and the laboratory's ability to perform the analyses are resolved prior to commencing work. c) Review of any request for work is documented in the project file, at a minimum as review of the COC and sample receipt confirmation sent to the client. More extensive requests that include a contact or QAPP, etc., entail further documentation and approval signatures. 3.2. Apex's Statement of Qualifications includes a list all test methods the laboratory is able to perform and the extent of accreditation for each test method and applicable matrix.13 The laboratory's protocol for development and validation of alternative methodologies is documented as Apex SOP Q-108. 3.3. Amendments, Deviations & Complaints – Pertinent client communications during routine samples analyses may be documented as notes in the project file or retained electronically as emails or entries in Element.14 a) Amendments to a client's request for work (whether a COC or QAPP, etc.) are reviewed as above Page 8 of 55 Apex Laboratories, LLC Quality Assurance Manual Rev No 3, 06/30/11 b) and are communicated to the appropriate personnel and documented accordingly.15 If there are changes in Apex's accreditation status relevant to a client's work or the laboratory deviates from the agreed upon protocols during performance of the work, such changes are communicated to the client for timely resolution and are documented accordingly.16 3.4. Apex is amenable to client's request to monitor laboratory performance through project specific QC, split samples, performance test samples, and/or client audits.17 3.5. Any complaint a client has against the laboratory's service or reported data will be handled by the appropriate management or QA personnel. The extent of corrective action and documentation warranted will be determined by the nature of the compliant and may include an amended Analytical Report, a nonconformance report and/or inclusion in the annual QA report to management.18 4. Organization & Responsibility 4.1. Apex is an independently owned and operated laboratory and is not part of a larger organization. The laboratory does not perform business activities other than those associated with environmental testing, therefore the potential for conflict of interest in the roles of key personnel is minimal.19 The laboratory's management team consists of the Laboratory Director, the Technical Manager, the Business Director and the QA Manager. The laboratory management and quality systems cover all work conducted by Apex personnel at the laboratory facility or on behalf of the laboratory at a client location.20 Employees may fill multiple roles in the laboratory in order to provide coverage in all areas at all times. Each employee is fully trained in any new tasks they are assigned, and must demonstrate proficiency before being allowed to work independently on client samples. Where applicable, the organizational chart (Figure 1.) shows an employee's secondary responsibilities in parentheses under the appropriate department. 4.2. Organizational Structure The organizational chart (Figure 1.) depicts the structure of the laboratory organized per department and the independent relationship of quality assurance, technical operations and business development.21 Personnel responsible for supervising the work of a department are bolded on the organizational chart. No name bolded for a department indicates that all personnel are at an equivalent experience level sufficient that supervision other than by the Technical Manager is not required.22 The organizational chart and position descriptions below, in conjunction with the Code of Ethics (Apex SOP Q-101), define the responsibility, authority and interrelationship of personnel responsible for data integrity.23 4.3. Job descriptions of key positions24 A brief job description for key positions within the laboratory are given below. The names of personnel filling these positions are given in the organizational chart (Figure 1.) and Apex’s Statement of Qualifications (SOQ) contains detailed descriptions of their relevant experience. Deputies assigned in the absence of the key positions (Laboratory Director, Technical Manager, Business Development Manager and QA Manager) are indicated on the organizational chart (Figure 1.)25 a) Laboratory Director - Responsible for the overall laboratory functions, including daily laboratory operations and adherence to technical standards. The Laboratory Director works in conjunction with Page 9 of 55 Apex Laboratories, LLC Quality Assurance Manual Rev No 3, 06/30/11 the Technical Manager and Quality Assurance Manager to ensure that adequate technical and staffing resources are available for the work being performed. Responsibilities also include project management and reporting, as well as purchasing, facilities management and supervision of laboratory employees. b) Quality Assurance (QA) Manager - The Quality Assurance Manager role will be filled by someone who meets the minimum requirements of the 2003 NELAC standard Section 5.4.1.5.i, including general knowledge of analytical methods performed by the laboratory and documented quality assurance training. Responsible for developing, implementing and maintaining the laboratory's Quality System. Ensures that the Quality System is relevant to laboratory operations and complies with analytical methods and applicable standards.26 Duties: 27 i Oversees the auditing of laboratory and system operations, and any necessary corrective actions. ii Oversight of QA/QC data review & assessment of compliance with laboratory quality objectives, independent of any outside influences. iii Works in conjunction with the Technical Manager to determine the minimum qualifications for all technical positions. iv Ensures that personnel are appropriately trained and that training is documented. Maintains training records. v Maintains laboratory accreditations, including proficiency testing22, 32and communicates with state and federal agencies regarding all accreditation matters. vi Communicates the ongoing status of Quality System compliance to management, including the Annual Quality Report to Management referenced in Section 19.3 of this manual. vii Maintains current revisions of controlled documents including the Quality Assurance Manual and SOPs.28 viii Maintains method development and validation documentation, including MDL studies. c) Technical Manager - The Technical Manager role will be filled by someone who meets the minimum requirements of the 2003 NELAC standard Section 4.1.1.129 Responsible for managing the technical functions of laboratory operations, including monitoring analytical capabilities, ensuring adequate resources, performing technical project assessments and monitoring the validity of analyses performed and data generated to assure reliable data. The Technical Manager oversees method development and manages laboratory data systems, including the LIMS system and electronic infrastructure, along with report and deliverable design. The Technical Manager works in conjunction with the Quality Assurance Manger to determine the minimum qualifications for all technical positions and ensure adequate training.30 The Technical Manager also works closely with the Quality Assurance team to implement and maintain the quality system, and ensure adherence to it.31 d) Business Development Manager - Responsible for business development and client relations, including determination of the laboratory’s ability to meet project specifications. In conjunction with the Laboratory Director, the Business Development Manager performs client project management and reporting activities. Other responsibilities include overseeing sample receipt and courier operations. Page 10 of 55 Apex Laboratories, LLC Quality Assurance Manual Rev No 3, 06/30/11 e) Project Manager (PM) – Responsible for primary contact with the client. The PM is responsible for clarifying client requests and monitoring the laboratory's performance in relation to the work performed. The PM advises clients of any subcontracting of work whether because of unforeseen reasons or on a continuing basis and gain approval from the client for such work, preferably in writing. Produces and reviews final reports for completeness and accuracy. The PM must also ensure client confidentiality. f) Sample Receiving Supervisor - Reports to the Business Development Manager. Supervises sample control technicians who are responsible for sample receipt and login, including the completeness of all sample receipt documentation for incoming samples and projects. Sample Control Technicians also prepare sample bottles, fill client bottle requests and coordinate delivery of sample containers for client sampling and subsequent sample pick-up. g) Laboratory Analyst - Responsible for preparation and/or analysis of samples in accordance with the relevant SOP and published method(s). Depending on their documented level of experience, analysts may also be responsible for training other analysts, data entry and review, instrument maintenance, preparation of analytical standards, and initiation of non-confromance reports. Analysts may be assigned additional secondary roles, such as serving on the safety committee, coordinating waste disposal activities, or working in a different department in the laboratory. In all aspects of work conducted, analysts are responsible for compliance with Apex's quality system, including the Code of Ethics' right of refusal and full disclosure (SOP Q-101 4.2.4 and 4.2.7) Personnel in key positions and lines of authority are depicted on the organizational chart in Figure 1 at the end of this document. 5. Training32 The selection of well-qualified personnel, based upon education and experience, is critical to the success and quality of the laboratory. In order to maintain a qualified staff and provide for personnel advancement within the laboratory, Apex follows a thorough program of orientation and training as detailed in Apex SOP Q-103. 5.1. Apex's training protocol is designed to provide a mechanism to document the competence of personnel and set appropriate goals for individual training. 5.2. Each new employee receives an orientation that includes familiarization with the Apex Orientation & Training SOP Q-103 and Training Record, the Quality Assurance Manual, the Safety Manual & Chemical Hygiene Plan (SOP SMO-001) and the Code of Ethics (SOP Q-101). 5.3. The level of experience upon hire, and the continuous training of each employee, is documented in an individual's Training Record by both the trainer and trainee initialing and dating the appropriate methods and level of training. a) Training is conducted as one-on one instruction by an experienced analyst on the specific analytical procedure to be performed. Employees are provided with the appropriate SOPs and reference methods, and are fully trained in all aspects appropriate to the training level of the procedure, including quality control and safety. b) Prior to preparing or analyzing any client samples without direct supervision, an analyst must demonstrate proficiency in the task through successful completion of a Demonstration of Capability Page 11 of 55 Apex Laboratories, LLC Quality Assurance Manual Rev No 3, 06/30/11 (DOC) (Refer to Apex SOP Q-107). c) Original Training Records are retained in each department for ease of access. 5.4. An individual training file is kept for each employee in the QA department. Each employee training file contains: a) A completed Initial Training Signature Sheet to document initial orientation and certify understanding and agreement to comply with Apex's QA Manual. b) A completed Training Record Documentation Agreement to certify understanding and agreement to comply with Apex's training protocol. c) A completed Apex Laboratories Safety & Environmental Orientation form to document initial safety training. d) A completed Ethics Agreement and Training Form to document initial ethics training and agreement to comply with Apex's Code of Ethics. e) A copy of the individual's Training Record. f) A signed hard copy of the individual's annual Demonstration of Capability of Certification Statement. g) Certificates of any training obtained from external sources. 6. Laboratory Responsibilities 6.1. Lines of Authority - The Laboratory Director is responsible for nominating deputies in the case of the absence of personnel in management or supervisory positions. The Business Development Manager assumes this responsibility in the absence of the Laboratory Director. 6.2. Approved Signatories - Apex Laboratories, LLC, provides environmental data for a variety of clientele. Management level positions are approved signatories for all reported data and controlled laboratory documents. Alternate signatories may be assigned in the case of an extended absence or leave to ensure normal work flow. 6.3. Independence of QA - The QA Department has a high degree of independence and authority in the laboratory’s organization. The QA Department reports directly to the Laboratory Director to review the work of groups and individuals, and is independent of production pressures that associated with generating or compiling data. 7. Facilities, Equipment & Supplies33 7.1. Facility Apex Laboratories, LLC is a 7800 square foot main facility, with a 6000 square foot secondary facility dedicated to environmental analytical services and divided into separate areas for sample receipt and laboratory departments. The floor plan is organized in such a manner as to minimize cross contamination between analytical procedures and maximize work flow efficiency. The laboratory’s floor plan is depicted Page 12 of 55 Apex Laboratories, LLC Quality Assurance Manual Rev No 3, 06/30/11 in Figure 2 at the end of this document. Apex does not have mobile laboratory facilities. 34 7.2. Equipment35 Apex analysts operate and maintain a wide variety of state-of-the-art analytical instrumentation and equipment for the performance of a variety of chemical analysis. All instruments and analytical equipment are subject to service and preventative maintenance procedures per manufacturer instruction to minimize the occurrence of failure or malfunction. Each instrument used for testing is uniquely identified and has it's own instrument logbook which is kept near the instrument. All maintenance is documented in the appropriate instrument logbooks. A detailed list of instrumentation is maintained in Apex’s Statement of Qualifications for accurate assessment of the laboratory’s capabilities. 7.3. Procurement of supplies Apex purchases all supplies associated with samples analyses, such as gases, chemicals and sample containers, from reputable suppliers and maintains records of lot numbers when applicable. Chemicals, bottles and standards are tested prior to use in the laboratory. Volumetric dispensing devices, such as glass microliter syringes, must be procured from vendors with ISO 9001 certification, or otherwise be certified to meet the requirements for Class A glassware. 8. Sample Management Most samples submitted to Apex Laboratories are sampled by our clients, either directly or through the use of third party sampling services. Apex provides limited sampling services for storm water monitoring and other projects. Prior to sampling, clients receive appropriate sampling containers with preservatives from the laboratory. This service is extended to our clients to ensure that the proper containers are used for the requested analyses, and that the containers used are clean and contain the appropriate preservative. At login, sample container information is recorded and Apex may qualify results from samples received in containers that were not provided by the lab or were sampled in improper containers. 8.1. Analysis Requests Analytical methods used by Apex are those specified by regulatory agencies such as the U.S. Environmental Protection Agency (USEPA), including SW-846 methodologies and the Code of Federal Register Guidelines, ASTM, Standard Methods or state agencies. Any deviations from these methods are documented in the related Standard Operating Procedures. Ideally, clients coordinate with the Laboratory Director, Business Development Manager and/or designated Project Manager prior to sampling to ensure that correct sampling procedures, containers and preservatives are employed for the analytical method best suited to the matrix and end use of the analytical data. Chain of Custody (COC) forms accompany all bottle orders to be completed at the time of sampling, and are provided to clients in bulk for unscheduled projects. If prior planning is not possible, analysis requests may be made by the client and documented at the time of sample receipt. Figure 3 at the end of this document is an example of an Apex COC. Page 13 of 55 Apex Laboratories, LLC Quality Assurance Manual Rev No 3, 06/30/11 8.2. Sample receipt 36 a) The Sample Control department is responsible for receiving samples from the clients or their designees. Samples are routinely delivered to the laboratory by the client or sampler, commercial courier or delivery service (UPS/Fed Ex/DHL), or may be picked up by Apex courier. The COC is signed by both the client and the sample control personnel or Apex courier upon receipt, documenting transfer of custody to the laboratory. Commercial delivery services are not required to sign COCs as long as the cooler has remained sealed while in custody. b) When samples arrive at the laboratory, the COC accompanying the samples is reviewed to confirm that all pertinent information is filled out, including client name and address, project name and number, sample name and matrix, number of containers, required turnaround time and date /time sampled. Sample control personnel verify the following parameters: i Sample containers received correspond to those on the COC, and containers are intact. ii Sample volume, container, preservation and temperature are correct for requested analyses. iii Adequate time is allowed to meet holding time requirements for the requested analyses. iv Samples are not visibly damaged or compromised. c) Sample conditions as received are documented using the Apex Cooler Receipt Form form during cooler receipt and inspection. Once custody is taken, cooler and sample conditions are recorded on the Cooler Receipt Form, the COC information is checked and entered into Element, Apex sample labels are printed. Samples are labeled with their unique container identifiers (labels) and placed into the appropriate storage location prior to analysis. When sample control personnel enter all pertinent sample information into Element, a work order number is assigned to the sample delivery group, unique individual sample and container identifiers are created, and the samples are placed into extraction and analysis queues. Project specific information pertaining to the samples and requested analyses is also entered into Element when applicable. d) If there are any inconsistencies in the chain of custody or problems with sample receipt or login, they are noted on the Cooler Receipt Form and the Apex project manager is notified immediately and the client contacted. Detailed descriptions of protocols for all aspects of sample control, including handling, tracking, acceptance, and storage are contained in Apex SOP L-001 R0 Sample Receipt, Login, Subsampling, and Subcontracting, and L-003 – Sample Management Tracking and Storage. Figure 4 at the end of this document is an example of an Apex Cooler Receipt Form. 8.3. Subcontracting of samples37 a) When clients request an analysis not performed in-house by Apex employees or exceeds laboratory capacity, sample control personnel will arrange for the samples to be delivered to and analyzed by a laboratory with the appropriate certification. b) Client notification and approval is required prior to subcontracting of any samples. The certifications and Quality Assurance Manuals of all subcontract laboratories utilized by Apex should be maintained by the QA Department. A subcontract COC is prepared to accompany the samples and document transfer of custody to the subcontract laboratory. Subcontract custody documentation is retained with the project folder. Apex assumes responsibility for coordinating all reporting and QC requirements between the client and subcontracting laboratory, along with the release of final data. Page 14 of 55 Apex Laboratories, LLC Quality Assurance Manual Rev No 3, 06/30/11 c) Subcontracted data is received either electronically or in hardcopy form. The full subcontractor's report is included with our Apex report to the client. When possible, the subcontracted data is included in the text of the Apex report and identified as subcontracted data. See also Apex SOP L-001 - Sample Receipt, Login, Subsampling and Subcontracting, Section 6.1. 8.4. Sample Handling a) Storage Samples are stored in accordance with conditions listed in the individual methods. All soil samples and all water samples, except acid preserved samples for metals analysis only, are refrigerated and maintained at less than 6°C, but not frozen. Acid preserved polyethylene bottles for metals analyses only are stored at ambient temperature in a designated storage location. Samples stored away from all standards, reagents, food and other potentially contaminating sources. Client sample storage location is documented in Element. b) Tracking Prior to commencing work on a set of samples, the extractionist or analyst will create a bench sheet in Element and add the desired samples to the batch by selecting the bottle to be used. The bench sheet is used to track information relating to all aspects of extraction including sample amount, date and time of extraction, person performing the work, spike standard IDs and amounts, along with any comments relevant to the sample or samples in the batch. Sample analysis may be tracked by creating an analytical sequence in Element for organics analyses including GC and GC/MS techniques. Analytical batches and sequences are assigned unique identification numbers by Element. c) Disposal Refrigerated samples are kept at 6oC for the remainder of the month in which they are received and the following month. Samples are retained for at least two full months after receipt. Samples are then disposed of according to laboratory determined disposal procedures which meet DEQ guidelines. Samples deemed hazardous may be returned to the client. 9. Environmental Test Method Selection, Validation & Documentation Apex Selects methods for environmental testing which meet the needs of the client and which are appropriate for the environmental tests it undertakes. 9.1. Method Sources Most of the analytical methods used by Apex are those specified by regulatory agencies such as the U.S. Environmental Protection Agency (USEPA), or the Code of Federal Register (CFR) Guidelines. The following is a partial list of method references used by Apex: a) Test Methods for Evaluating Solid Waste, Physical/Chemical Methods, U.S. Environmental Protection Agency, SW-846, 3rd Edition, September 1986, Update l, July 1992 and Update ll, September 1994. b) Methods for Chemical Analysis of Water and Wastes, EPA-600/4-79-020, Revised 1983. Page 15 of 55 Apex Laboratories, LLC Quality Assurance Manual Rev No 3, 06/30/11 c) Standard Methods for the Examination of Water and Wastewater, American Public Health Association, American Water Works Association, and Water Pollution Control Federation, 20th Edition (1999). d) Guidelines Establishing Procedures for the Analysis of Pollutants Under the Clean Water Act , 40 CFR, Part 136. e) Oregon Department Of Environmental Quality, test methods as contained in OAR 340-122. f) Washington Department of Ecology, test methods as defined in WAC 173-300 – 173-340 g) ASTM Standards 9.2. Standard Operating Procedures38 Apex Laboratory maintains SOPs that accurately reflect all phases of current laboratory activities including Quality Assurance, General Laboratory Procedures, and Test Methods. All SOPs are internally written documents with adequate detail to allow someone (with similar qualifications to the analyst), other than the analyst, to reproduce the procedures used to generate the test result. 9.3. Method detection limits (MDL) Method Detection Limit studies are performed in accordance with 40CFR part 136 Appendix B, MDL Study specifications, upon introduction of any new analyte, matrix type, instrument, technique or following significant changes to any one of these. The MDL is verified annually for each matrix, method and analyte. MDL studies are not performed for some methods where spiking standards are not available or the reporting scale is not determined by low-level sensitivity or precision, such as pH, Solids, Temperature, or Turbidity. 9.4. Method reporting limits Method reporting limits are usually set at two to five times the method detection limit (MDL) above. Documentation of an acceptable MDL study and demonstrated method reporting limit capability for each analytical instrument must be in place prior to analysis of client samples. When applicable, MRL values are adjusted for sample dilution and percent dry weight of solid samples. 10. Calibration & Maintenance 10.1. Instrument calibration39 a) Apex calibrates all instrumentation using certified traceable reference materials. Calibration procedures for routine analyses are performed in accordance with approved appropriate analytical methods and documented in the relevant analytical SOPs. No points may be deleted between the high and low points of an initial calibration curve in order to meet QC criteria, however points at the high or low ranges of the curve may be deleted to improve the curve fit as long as the minimum number of points is retained and the limitation in analytical range and/or reporting limit are not detrimental to the data quality objectives. Method specific guidelines for calibrations are followed when available, and Apex specifies preferred calibration criteria when they are not. At a minimum, Apex analysts prepare calibration curves in accordance with the following criteria: Page 16 of 55 Apex Laboratories, LLC Quality Assurance Manual Rev No 3, 06/30/11 i ii iii iv Calibration is comprised of at least three points. Calibration is verified by a second source, if available. Lowest point of the calibration curve must be at or below the MRL. Internal calibration point or level cannot be deleted. b) All calibration standard preparations are entered in to the Element data system. Information such as concentration of the standard used, dilution volumes, solvent, date prepared, manufacturer's lot number, and the name of the analyst is recorded to ensure the calibration may be reconstructed if necessary. To assure that calibration standards are prepared correctly, an external quality control standard from a secondary source is analyzed each time a new calibration is prepared. c) Initial calibration curves are verified by continuing calibration standards every twelve hours for organic methods or every ten samples for inorganic methods. Sample analysis is not performed until the calibration has been verified. If the continuing instrument calibration verification results obtained are outside established acceptance criteria, corrective actions are performed. If routine corrective action procedures fail to produce a second consecutive calibration verification within acceptable limits, then the analyst must demonstrate acceptable performance after corrective action with two consecutive calibration verifications or a new initial instrument calibration must be performed. d) If samples are analyzed with an unacceptable calibration, all associated samples will be reanalyzed. If reanalysis is not possible, data associated with an unacceptable initial instrument calibration shall be reported with appropriate data qualifiers.40 Data associated with an unacceptable continuing calibration verification (CCV) may be fully useable under the following special conditions: i When the acceptance criteria for the CCV are exceeded high, and there are associated samples that are non-detects, then those non-detects may be reported. ii When the acceptance criteria for the CCV are exceeded low, those sample results may be reported if they exceed the applicable maximum regulatory limit level. e) Sample data is traceable to the calibration source through unique method (calibration) names recorded on all hard copy data. Instrument calibration curves can be entered into Element for most analyses utilizing analytical sequences. 10.2. Instrument Maintenance41,42 a) Apex’s instrument preventive maintenance program complies with instrument manufacturer recommendations and is designed to maximize instrument performance and minimize downtime. Maintenance schedules for instrumentation are included in the related analytical SOPs. All maintenance carried out on an instrument is documented in the instrument logbook kept with the instrument, and is followed by the appropriate calibration and/or calibration verification procedures. b) Instrument logbooks must include the following information: i The identity of the item of equipment and it's software. ii The manufacturer's name, type identification, and and serial number or other unique identification. iii Current location. iv The manufacturer's instructions, or reference to their location. v All maintenance carried out to date (documentation on all routine and non-routine maintenance activities). Page 17 of 55 Apex Laboratories, LLC Quality Assurance Manual Rev No 3, 06/30/11 vi Any damage, malfunction, modification or repair to the equipment. vii Date received and date placed in service (if available). viii Condition when received if available (used, new, reconditioned). c) In the event a problem arises which cannot be corrected in-house, manufacturer trained service technicians are contracted and brought on-site (service calls are also documented in the instrument logbooks. 10.3. Reference standards43 In general, unless a higher grade is required per method or instrument sensitivity, all chemicals used are reagent grade or higher, and all standards traceable to ACS or NIST reference standards. Whenever possible, Apex maintains independent source standards for each analysis to allow for verification of calibration standards. All reference materials are assigned a unique identification number upon receipt that is retained with the traceability certification and entered into Element. Records of all stock and intermediate standard solutions prepared, including information on reagent and solvent purity, lot numbers, analyst’s initials and preparation dates are maintained in Element. All standard solutions are validated prior to use. The validation procedure is typically verification of concentration using a standard prepared at a different time or obtained from a second source. All standards are labeled with an expiration date. 10.4. Support equipment44 Support equipment includes any devices for weighing, measuring, heating or cooling standards or samples. Support equipment includes, but is not limited to the following: analytical balances, ovens, refrigerators, freezers, water baths, thermometers, rotary extractors, water purifying systems, and volumetric dispensing devices. a) Quantitative results of analyses are highly dependent on the accuracy and reliability of support equipment, therefore, all support equipment is maintained in proper working order and calibration verified on a regular basis. The results of such calibration or verification shall be within the specifications required of the application for which this equipment is used or it shall be removed from service until repaired. Equipment which has been removed from service must be clearly labeled as such, or physically removed from the laboratory. b) Apex maintains ASTM class I certified reference weights for all analytical balances bracketing their range of use for analysis. Partial immersion and total immersion NIST traceable thermometers are maintained for thermometer calibration. Prior to use on a daily basis the calibration of each balance, oven, refrigerator, freezer and water bath is verified and documented. On a quarterly basis the calibrations of rotary extractors, and volumetric dispensing devices are verified. All other support equipment either has the calibration verified or is recalibrated at least on an annual basis. If operational conditions change or the instrument is moved, calibration verification must be performed before use. c) Glass microliter syringes are purchased from an ISO 9001-2000 certified vendor, such as Hamilton Company. Such syringes are manufactured to be accurate withing +/- 1% of nominal volume, with precision within 1% when measured at 80% of total scale volume. d) The Laboratory uses type 1 Deionized (ASTM (D1193-91)) water for all extractions and solutions. The system is checked weekly and preventative maintenance is performed bi-monthly. Page 18 of 55 Apex Laboratories, LLC Quality Assurance Manual Rev No 3, 06/30/11 11. Data Quality Objectives 11.1. Definitions The quality of data generated is always the top priority at Apex. The quality of the data generated is confirmed by assuring the data is accurate, precise, representative, complete, comparable and defensible as defined below. a) Accurate- The degree of accuracy is determined by the agreement between an observed value and an accepted reference or true value. Accuracy is ensured by adherence to analytical quality protocols and use of dual source certified reference materials for all possible methodologies. Accuracy is monitored through the performance of quality control check samples, matrix spikes, laboratory quality control spikes, and surrogate/internal standard spikes b) Precise - The degree of precision is determined by the difference in resultant value of two identically prepared items. Precision is ensured by adherence to protocols for replicate analyses. Precision is monitored by the performance of sample and/or field duplicates, matrix spike and control spike duplicates, and the subsequent calculation of relative standard deviation (RSD) or relative percent difference (RPD). c) Representative - The degree of representation is expressed by how accurately and precisely a point defines the mean characteristics of a population, parameter variations at a specific sampling point, or an environmental condition within a defined boundary. Proper representation is ensured by adherence to proper sample treatment protocol including appropriate analytical approved methodologies, adherence to holding times and analysis of field duplicate samples. d) Complete - The degree of completion is determined by the amount of valid data returned from any sampling set compared to the expected amount under normal conditions. Completeness is ensured by adherence to all quality protocols for every sample received. Apex makes a concerted effort to provide the most complete resultant data possible for every sampling set by minimizing laboratory error and instrument or electronic failure. e) Comparable - The degree of comparability is determined by the precision of one data set to another. Comparability is ensured by adherence to appropriate analytical methods and SOPs and consistent detection levels for each method routinely performed by Apex. Detection levels are evaluated annually to provide documented proof of limit appropriateness. External comparability is ensured by the use of common reporting units and general reporting protocols. f) Defensible - The degree of defensibility of a specific data set is measured by the completeness of documentation and traceability to certified standards for comparison. Apex will provide expert witness testimony regarding environmental analyses performed at Apex, if required. In order to provide the best quality for our clients, Apex maintains laboratory operating conditions such that all data associated with sample analysis can withstand scrutiny for legal purposes. The following definitions are found in the TNI Standard, Volume 1, Management and Technical Requirements for Laboratories Performing Environmental Analysis. They are included here for easy reference. Changes or additions to the TNI definition are included in italics. For further definitions, see the appropriate TNI section. Page 19 of 55 Apex Laboratories, LLC Quality Assurance Manual Rev No 3, 06/30/11 g) Analyst: The designated individual who performs the “hands-on” analytical methods and associated techniques and who is the one responsible for applying required laboratory practices and other pertinent quality controls to meet the required level of quality. h) Audit: A systematic and independent examination of facilities, equipment, personnel, training, procedures, record-keeping, data validation, data management, and reporting aspects of a system to determine whether QA/QC and technical activities are being conducted as planned and whether these activities will effectively achieve quality objectives. i) Batch: Environmental samples that are prepared and/or analyzed together with the same process and personnel, using the same lot(s) of reagents. A preparation batch is composed of one (1) to twenty (20) environmental samples of the same quality systems matrix, meeting the above mentioned criteria and with a maximum time between the start of processing of the first and last sample in the batch to be twenty-four (24) hours. An analytical batch is composed of prepared environmental samples (extracts, digestates or concentrates) which are analyzed together as a group. An analytical batch can include prepared samples originating from various quality system matrices and can exceed twenty (20) samples. j) Bias: The systematic or persistent distortion of a measurement process, which causes errors in one direction (i.e., the expected sample measurement is different from the sample’s true value). k) Blank: A sample that has not been exposed to the analyzed sample stream in order to monitor contamination during sampling, transport, storage or analysis. The blank is subjected to the usual analytical and measurement process to establish a zero baseline or background value and is sometimes used to adjust or correct routine analytical results. Blanks include: Method Blank: A sample of a matrix similar to the batch of associated samples (when available) that is free from the analytes of interest and is processed simultaneously with and under the same conditions as samples through all steps of the analytical procedures, and in which no target analytes or interferences are present at concentrations that impact the analytical results for sample analyses. l) Certified Reference Material (CRM): Reference material, accompanied by a certificate, having a value, measurement uncertainty, and stated metrological traceability chain to a national metrology institute. Also includes Standard Reference Material (SRM) m) Chain of Custody Form: Record that documents the possession of the samples from the time of collection to receipt in the laboratory. This record generally includes: the number and types of containers; the mode of collection; the collector; time of collection; preservation; and requested analyses. n) Holding Times: The maximum time that can elapse between two (2) specified activities. o) Internal Standard: A known amount of standard added to a test portion of a sample as a reference for evaluating and controlling the precision and bias of the applied analytical method. p) Limit(s) of Detection (LOD): A laboratory's estimate of the minimum amount of an analyte in a given matrix that an analytical process can reliably detect in their facility. Page 20 of 55 Apex Laboratories, LLC Quality Assurance Manual Rev No 3, 06/30/11 q) Limit(s) of Quantitation (LOQ): The minimum levels, concentrations, or quantities of a target variable (e.g., target analyte) that can be reported with a specified degree of confidence. r) Matrix: The substrate of a test sample. s) Matrix Duplicate: A replicate matrix prepared in the laboratory and analyzed to obtain a measure of precision. t) Matrix Spike (spiked sample or fortified sample): A sample prepared, taken through all sample preparation and analytical steps of the procedure unless otherwise noted in a referenced method, by adding a known amount of target analyte to a specified amount of sample for which an independent test result of target analyte concentration is available. Matrix spikes are used, for example, to determine the effect of the matrix on a method's recovery efficiency. u) Matrix Spike Duplicate (spiked sample or fortified sample duplicate): A replicate matrix spike prepared in the laboratory and analyzed to obtain a measure of the precision of the recovery for each analyte. v) Quality System: A structured and documented management system describing the policies, objectives, principles, organizational authority, responsibilities, accountability, and implementation plan of an organization for ensuring quality in its work processes, products (items), and services. The quality system provides the framework for planning, implementing, and assessing work performed by the organization and for carrying out required quality assurance (QA) and quality control (QC) activities. w) Quality System Matrix: These matrix definitions are to be used for purposes of batch and quality control requirements: Aqueous: Any aqueous sample excluded from the definition of Drinking Water or Saline/Estuarine. Includes surface water, ground water effluents, and TCLP or other extracts. Chemical Waste: A product or by-product of an industrial process that results in a matrix not previously defined. Drinking Water: Any aqueous sample that has been designated a potable or potential potable water source. Non-Aqueous Liquid: Any organic liquid with <15% settleable solids. Solids: Includes soils, sediments, sludges and other matrices with >15% settleable solids. The options available in the Element LIMS for matrix types tested at Apex are: Cartridge, Digest, Liquid, Oil, Paint Chip, Pore Water, Sediment, Soil, Solid, Transformer Oil, Water, and Wipe. Liquid may refer to aqueous or non-aqueous liquid that does not meet the definition of Water. Some of these Apex matrices may be combined for the purposes of an extraction batch. The above TNI definitions are generally used to establish extraction batches. x) Reference Standard: Standard used for the calibration of working measurement standards in a given organization or at a given location. Page 21 of 55 Apex Laboratories, LLC Quality Assurance Manual Rev No 3, 06/30/11 11.2. Criteria45 Data Quality Objectives (DQOs) are defined as the goals of accuracy and precision established for a data set to demonstrate freedom from bias. Apex’s data quality objectives are assigned from one of three sources: 1) EPA method specified criteria or published guidance such as Contract Laboratory Program (CLP), Functional Guidelines or the Department of Defense QSM; 2) internally derived criteria from control charts of analytical data; and 3) client mandated project specific criteria. EPA method specified criteria are included in Apex’s analytical SOPs when available and serve as the minimum requirements. All data quality objectives are maintained in Element and included in analytical reports. Client specific DQOs are coordinated between Apex and the client prior to commencement of work and are documented as a Quality Assurance Project Plan (QAPP) provided by the client. Data quality objectives are comprised of the internal and reportable quality control checks described below. 11.3. Instrument QC a) Calibration Verification Standards - At the start of each analytical sequence, a Calibration Verification Standard (CCV) is run to verify the continued applicability of the initial calibration. The standard or set of standards contains all of the analytes to be measured along with any internal standards or surrogates used. In most cases the calibration verification standard is from the same source as the initial calibration standard. Calibration verification standard acceptance criteria are established by the related analytical methods, or determined by Apex based on instrument and method limitations. These criteria are stated in the relevant analytical SOP. In general, if a calibration check standard does not pass the acceptance criteria, reanalysis of the standard is permitted if there is a reasonable cause for the initial failure. Potential reasons for failure of a CCV include: need for instrument maintenance, tuning, or conditioning; incorrect or degraded standard analyzed; sample introduction error; or instrument performance drift requiring recalibration. Corrections can be made for any of these conditions (except instrument drift) and a second CCV analyzed if the instrument operating parameters are not modified. For example, if a dirty GC injection liner causes a CCV failure, the liner can be replaced with an identical liner, conditioned as necessary, and a second CCV analyzed. If standards analyzed after corrections are made fail to match the current calibration, a new calibration curve must be run. i Conditioning runs and response checks are standard solutions analyzed to condition and test the system during and after maintenance. Conditioning runs/response checks and CCVs cannot be used interchangeably, and the intended use of any standards analyzed should be clear from the information contained in the analytical data. ii It is not acceptable to analyze repeated CCVs with the intention of accepting data based on a passing CCV without a reasonable cause for the initial failure. Repeated runs of any standard are only acceptable if instrument conditions have been corrected to match those of the current calibration curve. iii Calibration must be re-verified again every 20 samples for organic methods (except GC/MS) and every 10 samples for inorganic methods. Samples should be run using the same conditions as CCVs. For example, if a sequence of dirty samples requires repeated instrument blanks to be run prior to the CCV, then instrument blanks should be run between each sample as well. If sequences with multiple CCVs are used to analyze samples, failing CCVs will mean that data not bracketed by acceptable QC is not reportable. However, the failure of subsequent CCVs in a sequence (e.g. when a sequence runs overnight) will not automatically force recalibration, and the rules stated above for determining and correcting CCV failure still apply. Page 22 of 55 Apex Laboratories, LLC Quality Assurance Manual Rev No 3, 06/30/11 b) Instrument Performance Standards - Instrument performance criteria must be demonstrated when running GC/MS, GC/ECD, ICP or ICP/MS methods, and may include mass spectral tunes, analyte breakdown and tailing check standards, and interference check standards. At the beginning of every twelve-hour period, the instrument must pass the performance criteria defined in the respective analytical method and related Apex analytical SOP. c) Instrument Blanks - Prior to sample analysis, an instrument or extraction blank must be analyzed to assure that the analytical system is free of contamination. Analytes should not be detected above one-half the Method Reporting Limit (MRL) in the instrument or extraction blank for some analyses. See Apex Laboratory Policy #091016A, “Data assessment and qualification for blank detections” for further clarification. If it is determined that the blank is not free of contamination, corrective action must be taken to eliminate the source of contamination. Affected samples may be either reextracted and reanalyzed or the data appropriately qualified as specified below for method blanks, depending on the end use of the data. d) Internal Standards - A known concentration of Internal Standard is added to every standard, blank and sample being analyzed for organic parameters by GC/MS or metals by ICP/MS. Internal Standard calibrations compensate for minor fluctuations in instrument response by adjusting target analyte results based on Internal Standard responses. If fluctuations in the Internal Standard are more than the acceptance criteria, corrective action must be taken to solve the problem. Effected samples must be reanalyzed or the data reported as Estimated. 11.4. Extraction Batch QC a) Batch QC Source Selection – Matrix Spikes and Sample Duplicates that are performed on client samples should be analyzed on a systematic random basis, such as selecting the first and tenth sample assigned to the batch. Alternately, client samples that are known from historical analysis to be likely to provide useful information may be selected as the QC source. (e.g. Selecting a sample as the duplicate source that is suspected to have detections above the reporting level, or deliberately not selecting a sample that is suspected to have such severe matrix effects or high native analyte concentration as to preclude calculation of spike recovery.) b) Laboratory Control and Matrix Spikes - Laboratory Control Samples (LCS) and Matrix Spikes and Spike Duplicates (MS/MSD) are performed by spiking laboratory blanks or client samples, respectively, with a spiking solution containing some or all of the analytes of interest for the analysis. Laboratory control spikes are performed on matrix specific, analyte free media, while matrix spikes are performed on sample media. These analyses are a measure of method performance and accuracy and are done at a frequency of one out of every twenty samples, or one per extraction batch for all applicable methods. Accuracy data are expressed as percent recovery and acceptance criteria for laboratory spike recovery are derived from the appropriate analytical methods or listed sources, from internal control charts, or from client specified DQOs. If recoveries for the Laboratory Control Sample fall outside of acceptance limits, corrective action and reanalysis must be performed if possible. If reextraction and reanalysis are not possible, data will be qualified appropriately, or not reported at all. Out of control matrix spike recoveries, from batches with incontrol LCSs, are usually indicative of some form of matrix interference. Apex will qualify the reported data accordingly and inform the client of the sample matrix interference. c) Sample Duplicate Analyses – A percentage of all samples are analyzed in duplicate as a measure of analytical precision, expressed as relative percent difference (RPD). Sample Matrix Duplicates are performed on replicate (separately extracted) aliquots of actual samples. Sample Matrix Page 23 of 55 Apex Laboratories, LLC Quality Assurance Manual Rev No 3, 06/30/11 Duplicates are run at minimum rate of one per batch of twenty samples or less for all methods. Duplicate Matrix and/or Laboratory Control Spikes may also be run to demonstrate method precision. If RPD values for an LCS/LCS Duplicate pair do not fall within acceptance limits, corrective action and reanalysis must be performed, if possible. If reextraction and reanalysis are not possible, data will be qualified appropriately, or not reported at all. The rules for allowing marginal exceedences of LCS compounds is not used and all results are qualified when LCS componds are outside of control limits. Out- of- control Sample Duplicate or Matrix Spike RPD values, associated with in-control LCS RPDs, are usually indicative of interference with the specific sample matrix. Apex will qualify the reported data accordingly and inform the client of the suspected sample matrix interference. d) Method Blanks – One method blank is processed with each batch of samples to assure that the equipment and reagents being used are free of contamination. Analytes should not be detected above one half the Method Reporting Limit (MRL) in the method blank. If it is determined that the blank is not free of contamination, corrective action must be taken to determine the source of contamination. The affected samples must either be reanalyzed, or the data appropriately qualified. If an analyte is detected in a method blank at a concentration greater than one half of the MRL, the associated data is flagged in Element. Final qualification of the data is determined by analyst review and end use of the data; non-detected sample results are not qualified, sample concentrations less than five to 10 times the concentration detected in the method blank are qualified based on the client's end use of the data. See Apex Laboratory Policy #091016A - “Data assessment and qualification for blank detections” for further clarification. e) Surrogate Standards - Surrogates are compounds closely related to the compounds of interest, but not expected to be found in real world samples. All samples and QC are spiked with a known concentration of the surrogates before extraction for all GC and GC/MS methods. Surrogate recovery limits for each matrix are established in the same way as Lab Control Sample limits. For methods with multiple surrogates, only a certain number of surrogate recoveries may need to meet QC criteria, as reflected in the SOP. Samples should be reanalyzed if surrogate recoveries do not meet acceptance criteria and no interferences or matrix effects are suspected. Data with failing surrogates will be qualified based on the client's end use of the data. 12. Calculations Accuracy Measurements (Percent Recovery = P) Method Standards: P = 100 x observed recovery true concentration Matrix Spikes: P = 100 x ( observed - background ) spike concentration Average Recovery (P): P= Standard Deviation of Recovery: ∑ P n SD = ∑ 2 (P - P ) (n - 1) Page 24 of 55 Apex Laboratories, LLC Quality Assurance Manual Rev No 3, 06/30/11 Upper and Lower Control Limits (Recovery): UCL p = P + 3SD LCL p = P - 3SD Precision Measurements Relative Percent Difference: RPD = 100 x Mean RPD: R = UCL for Mean RPD: X1- X2 ( X 1 + X 2 )/2 ∑ RPD n R c = 3.27xR 13. Data Reduction, Validation and Reporting 13.1. Data reduction and primary analytical review a) An extractionist or analyst initiates the sample preparation process by querying Element for samples requiring the analysis to be performed. A bench sheet is created with a unique batch identification number for the samples to be extracted or digested. The bench sheet is printed out and used to document the sample preparation procedure, including the extractionist, date and time, sample amounts used, standards IDs and amounts and any comments relevant to the samples. Bench sheets are considered raw data and are retained in each department. b) Following analysis, instrument raw data is reviewed using the instrument software and all relevant reports are generated. Each analyst is responsible for the primary data review, including checking instrument performance criteria such as mass spectral tunes, blank evaluation and initial/continuing calibration checks prior to sample analysis. c) Whenever possible, instrument data is automatically acquired by commercially available software designed by the instrument manufacturers specifically for this purpose. Hard copy printouts of all instrument QC and sample data are generated at the time of acquisition or prior to any manual integrations or edits. For GC and GC/MS methods, each data file of an analytical sequence is reviewed electronically by the analyst for correct analyte identification and integrations and acceptable QC results. During this process, chromatograms for any necessary manual integrations are printed and added to the raw data packet for that sample. Following review, edited quantitation reports are reprinted, if necessary, and the sample raw data packet is initialed and dated by the analyst. The analyst then uploads the electronic data for the samples into Element using the companion DataTool instrument interface software, which allows for direct data uploads without the Page 25 of 55 Apex Laboratories, LLC Quality Assurance Manual Rev No 3, 06/30/11 need for manual entry. d) Metals data generated by ICP or ICP/MS and Wet Chem data generated by IC is also captured by manufacturer designed software specific direct acquisition software and printed out at the time of acquisition. Following the primary analyst's electronic review, the raw data for the sequence is similarly uploaded into Element. e) Wet chemistry data that is not electronically captured is manually entered into Element following primary review. f) Sample data is then queried from Element and undergoes the first level of review in Element. The analyst adds appropriate qualifiers, initiates reextraction or reanalysis if necessary, and updates the sample analysis status to “needs review”. 13.2. Secondary data review a) All hard copy sequence data is secondarily reviewed by a person qualified to perform the analysis, or who is trained in the specifics of data review of the particular analysis. Instrument data is reviewed against the electronic data in Element, and the package is evaluated against stated Data Quality Objectives. The appropriate corrective action is implemented and documented if a problem is found at any stage in the review process. b) The analyst and secondary reviewer similarly review GC and GC/MS calibration sequence data. Metals and wet chemistry calibrations are reviewed with the associated sample data. 13.3. Tertiary data review and reporting a) Tertiary review of all data for a given project is performed when the report is generated through the Element data system by project management. The report format includes sample and batch QC results (blanks, blank spikes, duplicates and matrix spikes) and analysis information such as analysis date and batch identification. Project narration, calibration data, instrument QC data, or client-specified component data packages are also available upon request. Once the project manager approves the data, a final report is generated electronically in Adobe .pdf format with the project manager’s electronic signature attached. Safeguards against unauthorized use of the electronic signature include password authentication and user specific privileges. The original Chain of Custody, Cooler Receipt Form, documentation of vital client correspondence and/or nonconformance issues are retained in the project file. Electronic Final Report and a snapshot of the table data used in the report is archived at the time of reporting so subsequent requests for EDDs or other report variations will come from the same subset of data, and include any modifications done in the original report. Figure 5 at the end of this document is an example of an Apex Analytical Report. Page 26 of 55 Apex Laboratories, LLC Quality Assurance Manual Rev No 3, 06/30/11 14. Naming conventions used by Element Element Naming Schemes (auto-assigned): Work Orders: LYYMNNN A10A001 Samples: AN -01 Container: A-Z A Standards: LYYMNNN A10H001 Batch Numbers: YYMNNNN 10H0001 Sequence Numbers: YMDDNNN 0H01001 Calibration IDs: LYMDDNN A0H0101 Batch QC/Instrument QC/Sample Naming: L Y YY MM M Lab Code Year Year Month (Num) Month (Alpha) N Sequential Number Day DD A 0 10 08 (Aug) A– L (JanDec) 0-9 01-31 Batch QC: (Batch Number - QC Type - Number) 10A80001-BLK1 Batch QC Blank 10A80001-BS1 Batch QC Lab Control Sample 10A80001-Dup1 Batch Duplicate 10A80001-MS1 Batch QC Matrix Spike 10A80001-MSD1 Batch QC Matrix Spike Dup 10A80001-PS1 Batch QC Post Spike (ICPMS) Instrument QC: 0H01001-TUN1 0H01001-CCV1 0H01001-CCB1 0H01001-ICV1 0H01001-CAL1 0H01001-IBL1 0H01001- etc… Samples: A10A001-01 (Sequence Number - QC Type - Number) MS Tune Sample Continuing Cal Std Continuing Cal Blank Initial Cal Verification Calibration Standard Instrument Blank Work Order A10A001, Sample -01 15. Control of Nonconformance and Corrective Action 46 15.1. Any aspect of the environmental testing work conducted by the laboratory that fails to comply with the standards of the laboratory's quality system, agreed upon client requirements, and/or accepted regulatory guidelines constitutes a nonconformance event. Appropriate documentation and corrective action steps must be taken in a timely manner for all noncomformances as detailed below. Documentation and corrective action steps, as well as the level of responsibility at which they are dealt with, are dependent upon the type of noncomformance, the extent of deviation and its impact on data. a) Types of nonconformance documentation and guidelines for timely resolution in ascending order of severity are listed below and explained in detail in Section 15.8. More than one type of documentation may be applied to a nonconformance event. i Documentation in the data and qualification of results – immediately upon data entry. ii Case Narrative on the Analytical Report – before final report issued. iii Nonconformance Form retained by the QA department – completed/finalized within 2 weeks of nonconformance event. iv Amended Analytical Report – issued within 1 week after the nonconformance form finalized. Page 27 of 55 Apex Laboratories, LLC Quality Assurance Manual Rev No 3, 06/30/11 v Client notification/data recall – completed within 2 weeks after the nonconformance form finalized. b) Apex's system to accurately and consistently assess the impact of any nonconformance event on data quality and useability is based on potential known bias and the type of nonconformance. Types of deviations and the corresponding appropriate documentation and corrective action are characterized in Sections 15.2 through 15.5 below.47 Criteria for assessment of impact on data is covered in Section 15.8 c) Lines of authority and responsibilities for implementing corrective action, tracking nonconformance events, follow-up, and preventative measures are outlined in Section 15.6. and 15.8. 15.2. Laboratory & Sample Quality Control Nonconformance Problems related to QC data commonly identified by an analyst at the time of analysis, or during data review, are categorized below as pertaining to either laboratory QC issues or sample QC issues. Such issues are usually recognized prior to reporting results and are dealt with at the analyst level by either reanalysis or qualification of the data. Apex analytical SOPs and QC policies address specific QA for each noncoformance. a) Laboratory QC Nonconformance i Initial Calibration - Corrective action is initiated if the initial calibration criteria specified in the analytical method and related Apex SOP are not met. Identification of the cause of failure is essential. Routine corrective actions are to verify standard concentrations, perform instrument maintenance, and reanalyze the calibration curve. The cause of failure is identified and corrected prior to proceeding with curve reanalysis. ii Continuing Calibration - Corrective action is initiated if continuing calibration criteria are not met. Routine corrective actions are to reanalyze the continuing calibration standard, perform instrument maintenance, or run a new calibration curve if necessary. All samples analyzed with a continuing calibration standard outside acceptance limits are reanalyzed or adequately qualified. iii Laboratory Control Sample (LCS) Recoveries – Laboratory policy Spike Policy 091112A describes in detail the protocol followed when an LCS recovery falls outside acceptance limits. Corrective action is initiated if LCS recoveries are found to be outside acceptance limits. Poor recoveries could be due to extraction inefficiency, analyst error or instrument problems. The LCS may be reanalyzed to verify an out-of control situation. Corrective action requires reextraction and re-analysis of the associated samples, or appropriate qualification of the sample data if reanalysis is not possible. iv Method or Instrument Blanks - Laboratory policy Blank Policy 091016A describes in detail the protocol followed when analyte is detected in a blank. Method and instrument blanks should have analyte concentrations less than one-half of the Method Reporting Limit in order to avoid bias of sample results near the MRL. The source of any significant blank contamination is determined and eliminated. If the contamination is related to instrument contamination or carryover, maintenance can be performed and the blank and any samples reanalyzed. If the source is determined to be from the sample preparation steps or from the reagents, the samples should be reextracted or the data qualified appropriately. v Instrument Performance Standards - Corrective action is initiated when a GC/ECD, GC/MS, ICP or ICP/MS does not pass the method instrument performance criteria such as tune, breakdown and response factors. Normal corrective actions include cleaning or retuning the mass spectrometer, cleaning the GC inlet, or changing the cones on the ICP/MS. Page 28 of 55 Apex Laboratories, LLC Quality Assurance Manual Rev No 3, 06/30/11 b) Sample QC nonconformance When laboratory QC data are within acceptance limits, sample QC exceedances such as Sample Duplicate RPD, Matrix Spike recovery, Internal Standard response, Surrogate recovery and Postdigestion Spike recoveries are usually indicative of some form of sample matrix interference with the chosen methodology. i Corrective action for a sample QC exceedance may include reextraction and/or reanalysis of the sample to eliminate the possibility of analytical or preparation error. If the results of reanalysis are consistent with the initial results, the data is qualified accordingly. ii Significant sample QC deviations may warrant a Case Narrative on the Analytical Report written by the Technical Manager or QA Department. c) Issuance of a Nonconformance Form for laboratory and sample QC nonconfromances is not usually warranted, unless a laboratory QC deviation begins to occur frequently or the QC deviation is discovered after the data has been issued without qualification. i If a QC deviation is discovered after the data has been issued as a final report without qualification, documentation should include an amended Analytical Report and a Nonconformance Form noting the root cause and corrective action for the QC deviation and for reporting the data unqualified. ii Continued occurrence of a laboratory QC nonconformance requires documentation on a Nonconformance Form so that the root cause of the deviation can be investigated and resolved with the appropriate corrective action. 15.3. Procedural Nonconformance Unexpected occurrences of procedural errors during sample preparation or analysis, such as a sample going to dryness during concentration, should be documented in the raw data and the results qualified accordingly by the analyst. Qualification of results may also extend to a Case Narrative on the Analytical Report written by the Technical Manager or QA Department. Frequently occurring procedural errors warrant the use of a nonconformance form and a corrective action plan as described in section 15.2. 15.4. Expected Nonconformance48 The laboratory has protocols in place for accepting and performing work that does not fall within the usual scope of normal sample preparation and analytical methods. Apex's Weird Sample Plan and New Method Development and Validation SOP Q-108, provide the frame work to ensure that permitted deviations from and/or modifications of standard policies and procedures are thoroughly documented and data are accurately qualified and reported. 15.5. Technical Operations or Quality System Nonconformance49 Noncompliance issues that are not directly associated with analytical QC data may also arise; such deviations are considered operational noncompliances. When it is discovered that an aspect of the laboratory's normal operation deviates from laboratory policy and/or regulatory requirements, the QA department assumes responsibility for initiating corrective action. Examples of such a deviation might be: a refrigerator temperature exceedance during sample storage, or a balance used past its certification date. a) Operational deviations, including root cause and corrective action, are documented initially on a Page 29 of 55 Apex Laboratories, LLC Quality Assurance Manual Rev No 3, 06/30/11 Nonconformance Form and followed through to a level commensurate with the seriousness of the nonconformance. Technical and QA management assess the potential impact of a noncompliance on all associated reported results. b) Response to operational nonconformance issues that are recognized as a result of a client or regulatory agency audit are the responsibility of the QA department. Corrective action in such cases is documented as a formal audit response. 15.6. Responsibilities & Authority for Nonconforming Work50 The level of authority required to resolve a nonconformance issue is dependent upon the extent of the nonconformance as noted in the descriptions in Sections 15.2 through 15.5. a) Procedural, laboratory QC, and sample QC nonconformances are generally addressed at the analyst level by data qualification during data entry or data review. b) Extenuating procedural nonconformances, expected nonconformances for atypical samples, technical operations and quality system nonconformances need to be addressed at the management level (by the Technical Manager, QA Department and/or Laboratory Director) and require more extensive documentation than qualification of affected results. This usually involves a case narrative added at the beginning of the analytical report. c) Apex's nonconformance policy is to empower analysts to be directly responsible for any noncompliance of data they generate. In accordance with Apex's Code of Ethics SOP Q-101- “All analysts have the right to, and are expected to, initiate a stop work investigation in the event that work fails to comply with the standards of the laboratory's quality system and/or accepted regulatory guidelines. Each analyst is responsible for collaborating with QA and the Technical Manager to investigate any situation that could potentially compromise data integrity and take the corrective actions necessary to resolve the nonconformance.” d) Resolution of extenuating nonconformances is considered a collaborative effort between the analyst, Technical Manager, QA, project management and the Laboratory Director. However, because the Laboratory Director is ultimately responsible for all reported test results, corrective action steps that involve stopping and/or resuming production or withholding or amending results are enacted under the final authority of the Laboratory Director.51 If the analyst, Technical Manager and/or QA Manager disagree with the Laboratory Director's corrective action decision, dissent is documented. 15.7. Response Time a) Corrective action is initiated as soon as possible after a nonconformance is discovered. If the corrective action involves more than documentation in the data and qualification of results, the entire corrective action process, including root cause analysis and data assessment, may take several weeks to complete. In such cases: i An electronic Nonconformance Form is initiated and management notified immediately to begin the corrective action and assessment of impact on data process.52 The QA department controls the amount of time a nonconformance case is open by monitoring each electronic Nonconformance Form on the X:\ drive to closure, as indicated by the signed Nonconformance Form in pdf format in the same location. ii If data submitted to a client could potentially be significantly affected by the nonconformance, Page 30 of 55 Apex Laboratories, LLC Quality Assurance Manual Rev No 3, 06/30/11 the client is promptly notified via email that their data is under review and that further information will be forthcoming.53 The QA department is responsible for ensuring that resolution of the nonconformance is completed with the client. 15.8. Assessment of Impact a) For laboratory and sample QC nonconformances, assessment of the impact of the nonconformance on data is done at the analyst level. The assessment, and corresponding data qualification, is then incorporated into the data review process. b) Impact is usually limited to an analytical batch or sequence. c) For nonconformance events that are deviations from the quality system or technical operations policies (section 15.5), the impact on data is initially assessed by the analyst in conjunction with the Technical Manager to determine the amount of data affected and to what extent data integrity has been compromised. After the initial assessment by the analyst and Technical Manager, QA and the Laboratory Director are consulted to discuss possible courses of corrective action and compliance requirements.54 Element is used to determine all data potentially effected by a non conformance event. The following points outline criteria for assessment of impact on data quality for potential data recall. d) if the nonconformance event is a correctable error, such as a quantitation, transposition or transcription error, the data are corrected and reissued as an amended report with appropriate documentation. e) If the nonconformance event causes results to change from nondetect to detected, or vice versa, an amended Analytical Report with Case Narrative is issued. f) If the nonconformance event causes a specific known bias in the data and the amount of error introduced to the final results is significant in comparison to the level of the reported result and/or the error inherent in the analysis, results may be reissued as estimated and qualified for the potential bias. g) If there is no known bias associated with the nonconformance event, and/or the amount of error introduced to the final results is not significant in comparison to the level of the reported result or error inherent in the analysis, corrective action will entail internal documentation rather than reissuing data. 15.9. Corrective Actions, Preventative Measures and Follow up55 a) Corrective actions applicable to various types of nonconformances are given in Section 15.2. In general, the criteria for an acceptable corrective action are as follows: 56 i The investigation must start with a determination of the root cause of the nonconformance and identification of potential corrective actions. ii The corrective action chosen must be the most likely to eliminate the noncompliance and prevent recurrence. iii The extent of the corrective action must be appropriate to the magnitude and associated risk of the nonconformance. iv If the nonconformance casts doubt on the lab's compliance with it's own policies, the lab must ensure that the appropriate areas of activity are audited as soon as possible. Page 31 of 55 Apex Laboratories, LLC Quality Assurance Manual Rev No 3, 06/30/11 v b) Changes implemented as a result of corrective action should be documented and measurable for appropriate follow up. Documentation of corrective action is critical to ensuring that the changes implemented as a result of corrective actions are maintained and that nonconformance events are able to be tracked to assess laboratory performance.57 i Corrective actions for nonconformances that have minimal data impact, and are able to be executed to completion immediately, do not need to be documented further. For example, a blank spike recovery outside control limits may be resolved with re-extraction/reanalysis of the samples, documentation in the raw data and\or qualification of results, and does not require a nonconformance Form. ii A Nonconformance Form is used to document any nonconformance event that cannot be remedied immediately and fully documented as such in the data. iii Nonconformance forms should include: • The responsible analyst and an explanation of the nonconformance and root cause • data effected. • Initial and subsequent corrective actions, target completion dates and date of reissued reports. • QA, Technical Manager and Laboratory Director comments and approval. iv Documentation of changes implemented as a result of corrective action may include a laboratory policy or an SOP revision. v Nonconformance events and subsequent corrective actions are summarized and documented annually in the QA Report to Management for overall assessment of laboratory performance. Figure 6 at the end of this document is an example of an Apex Nonconformance form. c) The laboratory has the following measures in place in order to prevent the occurrence of nonconformances and to be able to readily identify them when they do occur:58 i The Apex Code of Ethics sets a standard for continuous improvement. ii There is an established policy for review of SOPs and most current methods. iii Regularly scheduled laboratory-wide and department specific status meetings provide a forum for identifying potential problems and preventing nonconformance. d) The effectiveness of corrective actions taken for nonconformance issues pertaining to the Quality System, technical operations and/or regulatory compliance is assessed by incorporating the issues into the next scheduled internal audit for the appropriate department(s).59 16. Documentation60 The laboratory maintains record keeping systems applicable to the scope of work conducted and sufficient to meet the regulatory requirements under which the work is conducted.61 Records are organized and stored to ensure easy retrieval and prevent loss or damage during retention.62 After the allotted retention time, hard copy records and data are disposed of in such a way that maintains client confidentiality.63 Types of records retained fall into two main categories; analytical data, and documentation supporting the quality system (including health & safety and hazardous waste disposal). 16.1. Analytical Data64 All laboratory activities that contribute to generating analytical results are documented promptly, legibly, Page 32 of 55 Apex Laboratories, LLC Quality Assurance Manual Rev No 3, 06/30/11 and in ink, in the appropriate place to indicate the task with the person's initials and the date the task was performed.65 Any corrections to raw data are made in such a manner that the original data are still legible. The correction is initialed and dated by the person making the correction.66 A note must be added if necessary to clarify the reason for the correction. Electronic documentation, including an audit trail of changes, is maintained in Element as the initials/date of the analyst responsible for the data.67 All analytical data necessary to reconstruct sample results and ensure traceability of all measurements are retained by the laboratory for a minimum of two years in hard copy and five years in electronic format68. Such data include, but are not limited to69: a) Chain of custody forms and sample receipt and tracking documentation.70 b) Standard preparation records, including reference material certificates of purity. c) Handwritten bench sheets completed with relevant information pertaining to sample preparation/ analysis, including standard/reagent IDs and any analyst notes. d) Support equipment data such as balance checks and refrigerator temperature logs. e) Instrument calibration data. f) Instrument data from the analysis of all samples, and instrument and batch QC samples, including: i Sample ID. ii Instrument & calibration ID. iii Any manual manipulations such as calculations or integrations. iv Documentation of data review. g) Analysis sequence logs. h) Instrument maintenance logs. i) Analytical reports (including sample results, sample preparation and analysis methods, QC results and acceptance criteria) & project specific client correspondence. 16.2. Analytical Data Storage Sample analyses are organized by preparation batch and analytical sequence. Each batch and analytical sequence is assigned a unique identification number in Element. (Please refer to Section 14 of this manual for Element naming conventions.71) Data are organized for storage by sequence number, except conventional chemistry parameter tests that do not involve an analytical sequence run on an instrument. Data for such tests are organized per batch. a) Data Storage by Sequence - For each successful analytical sequence run on an instrument, the laboratory prints out a hard copy packet of data and the electronic data is uploaded from the instrument software into Element. Upon completion and review, the sequence data packet, including the Element sequence log, is scanned into the data warehouse on the laboratory's network. Hard copy sequence data packets are stored chronologically in each department and periodically boxed and placed in the laboratory's main storage area. b) Data Storage by Batch - Benchsheets for batches are scanned into the data warehouse on the Page 33 of 55 Apex Laboratories, LLC Quality Assurance Manual Rev No 3, 06/30/11 laboratory's network. Analytical data organized by batch only are retained as hard copies per department. 16.3. Supporting Data Storage72 Data that is not stored by either sequence or batch is organized for retention and retrieval as outlined below. a) Traceability records for standards and reagents are kept in a binder by the department using the material. Standard preparation records are maintained in Element. b) Instrument maintenance logs are assigned a unique identification number entered into the log book of log books for tracking purposes. Completed log books are stored chronologically with other support data in the laboratory's main storage area. c) Loose leaf data such as balance checks and temperature logs are kept in a binder by the equipment. A full binder is transferred to a labeled folder and archived chronologically with other support data in the laboratory's main storage area. d) Infrequent support data, such as pipet and thermometer calibration records are kept in the QA department or in the department responsible for maintaining the calibration. 16.4. Quality System Documentation73 All records and data important in documenting the Quality System are retained by the laboratory in either electronic or hard copy format for a minimum of five years. The QA department maintains the following records including all previous and current versions: a) Analyst training records, including qualifications, education and experience including Demonstration of Capability (DOC) records for each analyst. b) Log of names and initials of all personnel who make logbook entries. c) Proficiency Testing results. d) Audit findings and corrective actions reports. e) Information & correspondence pertaining to accreditations. f) Method Detection Limit (MDL) studies. g) Annual Reports to Management. h) Nonconformance Reports, and all other documentation of data integrity. i) Standard operating procedures. j) Lab policies. k) Quality assurance manual and Statement of Qualifications. Page 34 of 55 Apex Laboratories, LLC Quality Assurance Manual Rev No 3, 06/30/11 16.5. Accessibility74 a) Access to active and archived data and records is controlled for hard copy data by limited access to the laboratory facility, and through computer log-in restrictions for electronic records. Retrieval of archived information is documented as the end product of the reason for the retrieval, for example as a data package or nonconformance report, etc.75 b) All data and records are made available for audits by regulatory agencies. To maintain client confidentiality76, audits by clients are limited to data and reports for the client's samples, and general data and records pertaining to Apex's QA system, such as SOPs and MDL, DOC and PT sample data. c) If ownership of the laboratory is transferred, all data and records, and the obligation to retain them, would be included in the transfer. In the event of business closure or bankruptcy, the applicable regulatory and state legal requirements will be met.77 17. Document Control78 17.1. Description and Explanation Documents that are fundamental to the laboratory’s quality system are issued as either controlled or regulated documents, according to Apex Policy 100928A Document Control79. Documents considered fundamental to the quality system include: the Quality Assurance Manual, standard operating procedures, laboratory policies, non-conformance reports, Analytical Reports, audit finding reports, audit response reports, Apex Change Memos, QA Reports to Management, etc. a) For a controlled document, the generation, distribution and period of use is controlled. This process is applicable to documents where periodic revision is mandated to ensure continuing suitability and compliance with applicable requirements.80 i Controlled documents are assigned a unique controlled document number, revision number, and effective date to clearly identify the time period a document is in force. Each page of a controlled document contains the document number, page number and total number of pages.81 ii The QA department maintains distribution records of all controlled documents and current revision status to ensure that a document is retracted at the end of the enforcement period.82 iii The original of each non-current revision is marked as obsolete and archived to document changes per revision.83 iv Apex's QA Manual and SOPs are maintained as controlled documents. Binders of hard copies of the current QA Manual and relevant SOPs are maintained in the QA department only; the most recent revisions of all SOPs are accessible to the laboratory electronically in read-only format.84 b) The generation of regulated documents is controlled, but distribution is not controlled to the extent that the number copies distributed is known. With the exception of laboratory policies (see Section 17.3 below), regulated documents are not expected to be revised. c) Controlled and regulated documents are assigned unique identification numbers for tracking. Page 35 of 55 Apex Laboratories, LLC Quality Assurance Manual Rev No 3, 06/30/11 17.2. Approval and Revision Controlled and regulated documents require the dated signature(s) of authorized personnel necessary to review and approve the document prior to use.85 A regulated document such as an Analytical Report only requires the signature of the project manager, where as a technical standard operating procedure requires the approval of the Technical Manager, QA Management and/or an appropriate representative from the analytical department. a) Review for an approval signature on a controlled document includes pertinent background information such as the applicable analytical method and/or changes made to the previous revision of the document being reviewed.86 b) Revisions of a controlled document require the same level of approval signatures as the original version and are re-issued as soon as practicable to incorporate necessary changes.87 17.3. Laboratory Policy Process The laboratory policy process was created as a means to document aspects of laboratory operation that are applicable to multiple SOPs or brief enough to not warrant an entire SOP. a) In order to keep the policy process efficient and flexible, policies are issued and maintained electronically. b) A hard copy of approval signatures for each policy is kept separately from the electronic format to allow for flexibility. Modifications that do not alter the intent of the policy do not require further approval signatures. Modifications that do alter the intent of the policy require the signature of one of the original signatories. Policy modifications are tracked by the date noted in the document footer.88 18. Computer Hardware, Software, Validation and Back-up Apex uses only commercially available computer hardware from reputable sources and software designed specially for analytical instrumentation such as Agilent Technologies ChemStation Software. The Laboratory Information Management System, Element, is developed by Promium, LLC and maintained internally by the Technical Manager and externally by a service contract with the manufacturer. The integrity of Element and instrumentation software is tracked in the related audit trails which document changes made in the system; and is verified by review of the raw data against the uploaded data, and review of the final report. 18.1. Back-up89 The laboratory's electronic data and documents are organized to facilitate easy retrieval by authorized personnel. To guard against potential loss, electronic records are stored in multiple locations, including an external hard drive kept off site. The Technical Manager assumes responsibility for ensuring that electronic records are kept in a format supported by the hardware/software necessary for retrieval. 90 Page 36 of 55 Apex Laboratories, LLC Quality Assurance Manual Rev No 3, 06/30/11 The diagram below illustrates the extensive electronic backup systems in place.91 automatic nightly back-up raw data on Instruments manually moved to active raw data folders folders on Server archived instrument folders on Server manually uploaded via Data Tool Backup Server auto back-up M/W/F Second hard drive on backup server manual back-up weekly External hard drive off-site Element SQL server data base + Data warehouse automatic storage of scanned data nightly back-up 19. Performance and System Audits92 In order to maintain accreditation and meet contractual qualifications Apex is subject to audits conducted by regulatory agencies and private clients. In addition to these external audits, Apex performs internal audits to support the Quality System and continuous improvement. The three types of audits outlined below are conducted according to a predetermined schedule by the QA department.93 The QA Manager may also delegate auditing tasks to qualified personnel independent of the activity to be audited.94 19.1. Performance audits are qualitative evaluations to assure that the Quality System requirements are being followed in the day-to-day analytical operations of the laboratory. a) Performance audits may include: Determining whether the current SOP meets the most up to date regulatory requirements and whether the SOP is being followed in the laboratory. ii Assessing analyst training and documentation of training. iii Evaluation of record keeping systems. iv Ensuring that adequate equipment, supplies and personnel are available for the audited analysis. v Auditing data as instrument data, in Element and as the final analytical report. vi Ensuring that corrective actions implemented for previous audit findings are in place.95 i b) Performance audit reports include the department, method(s) and analyst(s) audited, any findings and subsequent corrective actions and date of implementation. Performance audit reports are retained by the QA department.96 c) Corrective action for audit findings should be implemented as soon as possible. The time frame for completion of such corrective action will be determined by the QA Manager and included in the Page 37 of 55 Apex Laboratories, LLC Quality Assurance Manual Rev No 3, 06/30/11 audit report (usually 30 days).97 In the event that audit findings warrant data recall, effected clients will be notified in writing within 45 days of the audit report.98 d) Internal performance audits should be performed at least annually per department, or more often as needed at the discretion of the Laboratory Director or QA Manager.45 19.2. Proficiency Testing99 Proficiency tests (PT) are quantitative evaluations of laboratory performance to assure the accuracy of data being generated. PT samples are an integral part of maintaining the laboratory's accreditations.100 PT samples are purchased and analyzed by the laboratory for all analytes and matrices for which the laboratory reports results, except in cases where a PT is not available for a particular analysis. PT samples are prepared according to the manufacturers instructions and analyzed using the same procedures and QC requirements as normal samples including the following:101 a) PT samples are logged in to Element and assigned a work order number. The project manager role is assigned to a QA department representative. b) PT samples are prepared (extracted/ digested) and analyzed by the same analyst that usually performs the analysis, using the same methodology. c) The organization (per batch /sequence) and extent of analysis of the PT sample and associated batch QC and instrument QC are the same as for routine environmental samples. The PT sample should not be singled out as the source for batch QC. Batch QC for PT batches should be selected using the same criteria as non-PT batches. 102 d) PT sample results are entered into Element and the analytical data are retained the same as for routine environmental samples103. An Analytical Report is generated and retained with the electronic report sent from the PT provider. e) PT results are reported according to the PT provider's instructions, by either transcribing the results from Apex's Analytical Report onto the PT provider's reporting sheets and manually submitting them via fax or mail, or entering the results on the PT provider's web site.104 f) PT sample results submitted to maintain Apex's accreditation status will be generated from analyses performed only by the laboratory; the analyses cannot be subcontracted. Apex may send specifically designated PT samples to subcontract laboratories in order to assess their analytical capability. Such results may be submitted to the PT provider for assessment criteria, but not to maintain Apex's accreditation status.105 g) Apex may receive PT samples from a client as part of the client's QA protocol, but Apex will not knowingly analyze PT samples to support a client's own accreditation for an analysis.106 h) Prior to submission of PT results, Apex will not make any attempt to obtain PT result information from the PT provider or other laboratories participating in the PT study. If circumstances arise that compromise the integrity of Apex's participation in a PT study, Apex will withdraw from the study. 107 i) Once PT results are submitted by the laboratory, the PT provider reports results and acceptance or failure to the laboratory and any listed accrediting agencies.22 If a parameter does not pass, corrective action is taken to find the source of the problem. Analysis of a remedial PT may be part of Page 38 of 55 Apex Laboratories, LLC Quality Assurance Manual Rev No 3, 06/30/11 the corrective action. Generally, accreditation is based on successful completion of two out of three PT studies for each matrix and analyte. Certification is generally downgraded to “Provisional” for an analyte/matrix upon failure of that analyte in a single PT sample. Subsequent failure will likely result in suspension of certification until corrective action has been sufficiently completed and two successful PT sample analyses are completed. PTs are analyzed at least 2 times per year for each method and matrix analyzed in the laboratory. PT sample results and supporting data are readily available for review by any client or regulatory agency upon request. 19.3. Quality System Audits108 At least once per year the QA department conducts a review of the Quality System as a whole to determine any necessary revisions or additions to ensure the maintenance of a properly functioning and adapting system. a) The Quality System review should incorporate: i An assessment of the Quality Assurance Manual and any necessary revisions. ii New policies implemented. iii Examination of non-conformance issues and corrective actions, including any issues pertaining to non-compliance with Apex Code of Ethics SOP Q-101. iv Results of PT studies for the year and any remedial action. v Findings of performance audits and corrective actions. vi Client feedback and/or complaints. vii Changes in workload volume, instrumentation and analyses. viii Any external assessments/ audits, findings and responses. b) Quality System audit findings and proposed corrective actions are formally documented and submitted to the Laboratory Director and management team as an annual QA Report to Management. i The report is initiated as an open document and is finalized with documentation of the corrective action, usually within 90 days. (Substantial actions that require system changes may take longer, in which case the QA Report to Management is finalized with a proposed completion date for the corrective action.) ii The QA Report to Management is dated with the initiation date and is finalized by the management team signing and dating the final hard copy report. iii Signed final QA management reports are retained in hard copy or electronic format by the QA department for a minimum of 5 years. Page 39 of 55 Figure 1 – Organization Chart Page 40 of 55 Figure 2 – Floor Plan Apex Labs - Fire/Safety Hazards . Semivolatile GC-MS Semi-vol ECD Analysis Waste Room Metals Analysis Break Room Metals Prep DI Room Safety Fuels Extra ctions Shower/ eye wash Non-Flam Haz Waste Area Ext. Annex Ext. Restrooms Dishes office Walk in fridge office Sample Receiving KEY Confe rence room Fire Extinguisher office Chemical Spill Kits Page 41 of 55 Figure 3 – Chain of Custody The next page is an example of an Apex Laboratories Chain of Custody. Page 42 of 55 Page 43 of 55 Figure 4 – Cooler Receipt Form APEX LABS COOLER RECEIPT FORM Client: _______________________________________Element WO#: A11_________ Project/Project #: ________________________________________________________ Delivery info: Date/Time Received: [email protected]____________ By: _________________________ Delivered by: Apex Courier___Client___FedEx___UPS___Senvoy ___SDS___Other Cooler Inspection Inspected by: [email protected] Chain of Custody: Included? Yes ___ No ___ Signed/Dated by Client? Yes ___ No ___ Signed/Dated by Apex Personnel? Yes ___ No ___ Coolers: No. of Coolers: ________ Cooler #1 Cooler #2 Cooler #3 Cooler #4 Temperature (deg. C) ________ ________ ________ ________ Received on Ice? (Y/N) ________ ________ ________ ________ Temp. Blanks? (Y/N) ________ ________ ________ ________ Ice Type: (Gel/Real/Other) ________ ________ ________ ________ Condition: ________ ________ ________ ________ Cooler out of temp? (Y/N) Possible reason why: Samples Inspection: Inspected by: [email protected] All Samples Intact? Yes ___ No ___ Comments:______________________________ _______________________________________________________________________ Bottle Labels/COCs agree? Yes ___ No ___ Comments: _______________________ _______________________________________________________________________Containers Appropriate for Analysis? Yes ___ No ___ Comments: _______________ _______________________________________________________________________ Do VOA Vials have Visible Headspace? Yes ___ No ___ NA ____ Comments_______________________________________________________________ Water Samples: pH Checked and Appropriate (except VOAs): Yes___No___NA______ Comments: Additional Information: Labeled by: See Client Contact Form: Y Page 44 of 55 Figure 5 – Sample Report The next six pages are an example of a report generated out of Element by Apex Laboratories. Page 45 of 55 12232 S.W. Garden Place Tigard, OR 97223 503-718-2323 Phone 503-718-0333 Fax Apex Labs Wednesday, August 4, 2010 Philip Nerenberg Apex Labs 12232 S.W. Garden Place Tigard, OR 97223 RE: Performance Evaluation / Spring 2010 Water Remedial PT Enclosed are the results of analyses for work order A10F200, which was received by the laboratory on 6/17/2010 at 3:51:00PM. Thank you for using Apex Labs. We appreciate your business and strive to provide the highest quality services to the environmental industry. If you have any questions concerning this report or the services we offer, please feel free to contact me by email at: [email protected], or by phone at 503-718-2323. Apex Laboratories The results in this report apply to the samples analyzed in accordance with the chain of custody document. This analytical report must be reproduced in its entirety. Page 1 of 6 Evan Holloway, Quality Assurance Manager Page 46 of 55 12232 S.W. Garden Place Tigard, OR 97223 503-718-2323 Phone 503-718-0333 Fax Apex Labs Apex Labs 12232 S.W. Garden Place Tigard, OR 97223 Project: Performance Evaluation Project Number: Spring 2010 Water Remedial PT Project Manager: Philip Nerenberg Reported: 08/04/10 16:16 ANALYTICAL REPORT FOR SAMPLES SAMPLE INFORMATION Sample ID Laboratory ID Matrix Date Sampled Date Received Trace Metals 1 A10F200-01 Water 06/17/10 00:00 06/17/10 15:51 Apex Laboratories The results in this report apply to the samples analyzed in accordance with the chain of custody document. This analytical report must be reproduced in its entirety. Page 2 of 6 Evan Holloway, Quality Assurance Manager Page 47 of 55 12232 S.W. Garden Place Tigard, OR 97223 503-718-2323 Phone 503-718-0333 Fax Apex Labs Apex Labs Project: Performance Evaluation 12232 S.W. Garden Place Project Number: Spring 2010 Water Remedial PT Project Manager: Philip Nerenberg Tigard, OR 97223 Reported: 08/04/10 16:16 ANALYTICAL SAMPLE RESULTS Total Metals by EPA 6010C (ICP-AES) Analyte Result MDL Trace Metals 1 (A10F200-01) Copper Reporting Limit Units Matrix: Water 0.363 Apex Laboratories --- 0.0100 Dilution Date Analyzed Method 06/23/10 17:24 EPA 6010C Notes Batch: 1006383 mg/L 1 The results in this report apply to the samples analyzed in accordance with the chain of custody document. This analytical report must be reproduced in its entirety. Page 3 of 6 Evan Holloway, Quality Assurance Manager Page 48 of 55 12232 S.W. Garden Place Tigard, OR 97223 503-718-2323 Phone 503-718-0333 Fax Apex Labs Apex Labs Project: Performance Evaluation 12232 S.W. Garden Place Project Number: Spring 2010 Water Remedial PT Project Manager: Philip Nerenberg Tigard, OR 97223 Reported: 08/04/10 16:16 QUALITY CONTROL (QC) SAMPLE RESULTS Total Metals by EPA 6010C (ICP-AES) Analyte Result MDL Reporting Limit Units Dil. Spike Amount Source Result %REC %REC Limits RPD RPD Limit Notes Water Batch 1006383 - EPA 3015A Blank (1006383-BLK2) Prepared: 06/23/10 14:07 Analyzed: 06/23/10 17:18 EPA 6010C Copper ND --- 0.0100 mg/L LCS (1006383-BS2) 1 --- --- --- --- --- --- --- --- Prepared: 06/23/10 14:07 Analyzed: 06/23/10 17:21 EPA 6010C Copper 0.0543 --- Apex Laboratories 0.0100 mg/L 1 0.0556 --- 98 80-120% The results in this report apply to the samples analyzed in accordance with the chain of custody document. This analytical report must be reproduced in its entirety. Page 4 of 6 Evan Holloway, Quality Assurance Manager Page 49 of 55 12232 S.W. Garden Place Tigard, OR 97223 503-718-2323 Phone 503-718-0333 Fax Apex Labs Apex Labs Project: Performance Evaluation 12232 S.W. Garden Place Project Number: Spring 2010 Water Remedial PT Project Manager: Philip Nerenberg Tigard, OR 97223 Reported: 08/04/10 16:16 SAMPLE PREPARATION INFORMATION Total Metals by EPA 6010C (ICP-AES) Prep: EPA 3015A Lab Number Matrix Method Sampled Prepared 06/17/10 00:00 06/23/10 14:07 Sample Default RL Prep Initial/Final Initial/Final Factor 45mL/50mL 45mL/50mL 1.00 Batch: 1006383 A10F200-01 Water EPA 6010C Apex Laboratories The results in this report apply to the samples analyzed in accordance with the chain of custody document. This analytical report must be reproduced in its entirety. Page 5 of 6 Evan Holloway, Quality Assurance Manager Page 50 of 55 12232 S.W. Garden Place Tigard, OR 97223 503-718-2323 Phone 503-718-0333 Fax Apex Labs Apex Labs Project: Performance Evaluation 12232 S.W. Garden Place Tigard, OR 97223 Project Number: Spring 2010 Water Remedial PT Project Manager: Philip Nerenberg Reported: 08/04/10 16:16 Notes and Definitions Qualifiers: Notes and Conventions: DET Analyte DETECTED ND Analyte NOT DETECTED at or above the reporting limit NR Not Reported dry Sample results reported on a dry weight basis. Results listed as 'wet' or without 'dry'designation are not dry weight corrected. RPD Relative Percent Difference MDL If MDL is not listed, data has been evaluated to the Method Reporting Limit only. WMSC Water Miscible Solvent Correction has been applied to Results and MRLs for volatiles soil samples per EPA 8000C. Batch QC Unless specifically requested, this report contains only results for Batch QC derived from client samples included in this report. All analyses were performed with the appropriate Batch QC (including Sample Duplicates, Matrix Spikes and/or Matrix Spike Duplicates) in order to meet or exceed method and regulatory requirements. Any exceptions to this will be qualified in this report. Complete Batch QC results are available upon request. In cases where there is insufficient sample provided for Sample Duplicates and/or Matrix Spikes, a Lab Control Sample Duplicate (LCS Dup) is analyzed to demonstrate accuracy and precision of the extraction and analysis. Blank Policy Apex assesses blank data for potential high bias down to a level equal to ½ the method reporting limit (MRL), except for conventional chemistry and HCID analyses which are assessed only to the MRL. Sample results flagged with a B or B-02 qualifier are potentially biased high if they are less than ten times the level found in the blank for inorganic analyses or less than five times the level found in the blank for organic analyses. For accurate comparison of volatile results to the level found in the blank; water sample results should be divided by the dilution factor, and soil sample results should be divided by 1/50 of the sample dilution to account for the sample prep factor. Results qualified as reported below the MRL may include a potential high bias if associated with a B or B-02 qualified blank. B and B-02 qualifications are not applied to J qualified results reported below the MRL. Apex Laboratories The results in this report apply to the samples analyzed in accordance with the chain of custody document. This analytical report must be reproduced in its entirety. Page 6 of 6 Evan Holloway, Quality Assurance Manager Page 51 of 55 Figure 6 – Nonconformance Report Form APEX LABORATORIES NONCONFORMANCE FORM Severity (circle one): 1 2 3 - 1 2 3 Needs signatures of analyst and one QA/QC/TD person w/ documentation of decision. Needs QA/QC review (discussion among QA/QC/TD) w/ initials of all involved, documentation of decision and possible system modifications. Needs actions indicated in level 2 with signature of laboratory manager and follow-up to verify that system changes have been implemented. Levels 1 & 2 need only 1st page, level 3 needs 2 pages. Notification of Nonconformance: Date: Analyst/Department: Nonconformance: Root Cause: Initial Corrective Action: Samples Affected: QC Affected: Reviewed By / Date: Comments: (List Client(s), Work Order(s) and Sample(s) Affected) (List Batch and Instrument QC Affected) (Quality Assurance Department or Technical Manager / Date of review) (Comments from QA Department or Technical Manager) Page 52 of 55 Figure 6 – Nonconformance Report Form Follow-up to Corrective (List further steps to be completed to remedy Nonconformance, only if a Action: level 3 nonconformance) Target Completion Date: Project Management Notification: Project Manager Comments: (Comments from Project Manager, including documentation of client notification, if applicable) Subsequent Actions to be (if applicable) Taken: Date of Reissued Report (Date Amended Report sent to Client, if applicable) Quality Assurance Approval: QA Comments: (Comments from Quality Assurance Department) Subsequent Actions to be (if applicable) Taken: Corrective Action Completed? QA Approval: Date: Laboratory Manager Approval: Laboratory Manager: Date: Additional Comments: Page 53 of 55 Footnote#: 2003 NELAC Standard Section # : NELAC Checklist # 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 5.4.2.2.a, .b & .e 5.4.1.1 & 5.4.2.2 5.4.2.2 & 5.4.2.2c 5.1.1, 5.4.1.2 5.4.1.5.a 5.4.2.1 & 5.4.2.3 5.1.1 5.4.2.1 & 5.4.2.2d 5.4.2.6, 5.4.2.6.1-2 5.4.1.4.b 5.4.1.4.b, 5.4.1.5.c & d 5.4.2.3.i, 5.4.4.1 & 5.4.4.2 5.4.2.3.h 5.4.4.2 5.4.4.5 5.4.4.4 & 5.4.4.5 5.4.7 5.4.2.3.q & 5.4.8 5.4.1.4 5.4.1.3 5.4.1.5.e, .i.2 5.4.1.5.f. & g 5.4.1.5.f. 5.4.2.3.e. 5.4.1.5.j 5.4.1.5.i., 5.4.2.4 5.4.1.5.i.1-.6 5.4.2.5 5.4.1.5.h 5.4.1.5.h 5.4.1.5.h, 5.4.2.4 5.4.2.3.t 5.4.2.3.l 5.4.1.3 5.4.2.3.m 5.4.2.3.k 5.5.10.5 5.5.4.1.1a 5.4.2.3.j 5.5.5.2.2.1.i 5.4.2.3.m 5.5.5.2.1.a 5.4.2.3.l 5.5.5.2.1.a 5.4.2.3.n 5.4.2.3.o,p, 5.4.9.1 5.4.9.1.b 5.4.2.3.p 5.4.10.1 5.4.9.1. & 5.4.9.1.a 5.4.9.1.e 5.4.9.1.c 5.4.9.1.d 5.4.10.3 5.4.9.1., 5.4.9.1.a, 5.4.9.2, 5.4.10.2 & 5.4.10.6.a 1-3 5.4.10.3 5.4.10.4 51, 52, 55 17, 50 49, 53 2, 18 23 46, 47, 56, 57, 59 2 48, 54 82-88 22, 25 24, 26, 27 66, 105-112 65 113 116 & 117 115 & 119 134 74, 135 & 136 20, 21 19 28, 38, 60 30, 31 30 62 44 36, 80 37-42 81 35 33 32, 80 77, 234-250 69 19 70 68 521-523 288 67, 70 380 70 356 69, 71 356 71 72, 73, 137-139 140 73 145 138, 139 143 141 142 147 138, 139, 144, 146, 154 148-150 151 Page 54 of 55 Footnote#: 2003 NELAC Standard Section # : NELAC Checklist # 58 59 60 61 62 63 64 65 66 67 68 5.4.10.6.a 5.4.10.5 5.4.12.2.5.2.a-h 5.4.12 5.4.12.1.1, 5.4.12.1.2, 5.4.12.2.4.e 5.4.12.1.1 5.4.12.2.5.3.a-n 5.4.12.1.2, 5.4.12.1.5.a, d & e, 5.4.12.2.1, 5.4.12.2.2 5.4.12.1.5.d & f, 5.4.12.2.3 5.4.12.1.5.f, 5.4.12.2.3 5.4.2.3.g, 5.4.12, 5.4.12.1.2, 5.4.12.1.5, 5.4.12.2.4.b & 5.4.12.2.1 69 5.4.12.1.5.b & 5.4.12.2.1 70 5.4.12.1.5 71 5.4.12.1.5.c 72 5.4.12.2.4.d 73 5.4.12.1.1 & 5.4.12.2.5.4.a-c 74 5.4.12.3 75 5.4.12.2.4.e 76 5.4.12.2.4.a 77 5.4.12.2.4.f 78 5.4.2.3.d 79 5.4.3.1 80 5.4.3.2.2.b 81 5.4.3.2.3 82 5.4.3.2.1, 5.4.3.2.2.c 83 5.4.3.2.2.d 84 5.4.3.2.1 85 5.4.3.2.1 86 5.4.3.3.1 87 5.4.3.3.1 88 5.4.3.3.4 89 5.4.12.1.4 90 5.4.12.2.4.b 91 5.4.12.2.4.c 92 5.4.13.1, 5.4.2.3.s 93 5.4.13.1 94 5.4.13.1 95 5.4.13.4 96 5.4.13.3 97 5.4.13.3 98 5.4.13.2 99 5.4.2.3.n 71 1005.4.1.5.k 1012.5 1022.5 1032.5.2 1042.5 1052.5.1a 1062.5.1b 1072.5.1c 1085.4.1.5.i.7, 5.4.14.1, a-j, 5.4.14.2 153 152 208 161 164, 167, 168, 202 164 209 166, 174, 178, 179, 187-189 177, 180, 181, 183, 190, 192, 193 182, 184, 191 64, 160, 162, 169, 172, 185-188, 196-197 175, 185, 187 173 176 200 165, 210 170, 171 201 194 203 61 89 94 97 91, 95 96 92-93 90 98, 100 99, 103 104 171 198 199 76, 211, 212 217 215, 216 221 219 220 213, 214, 218 45 3, 4, 5, 7 8, 9, 10 16 11 12 13 14, 15 43, 222 - 231 Page 55 of 55
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