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HomeMy WebLinkAboutSmuggler Superfund - Blood Lead Surveillance Quality Assurance Plan, Univ of Cincinnati 1996V11,1110=1111 "M Prepared by the University of Cincinnati September 24, 1996 Pue Introduction I Overview I Interior Environmental Sampling 2 Exterior Environmental Sampling 2 Blood Lead Screening 3 Preparation For An Environmental Visit 4 Interior Dust Sampling Protocol 6 Equipment Calibration and Maintenance 7 Quality Control Procedures 7 Sample Custody 8 Analytical Procedures 9 Water 15 Sampling Protocol 10 Quality Control Procedures 10 Sample Custody 12 Analytical Procedures 12 Handwipe Sampling Protocol 13 Equipment Calibration and Maintenance 13 Quality Control Procedures 14 Sample Custody 14 Analytical Procedures 15 Soil Sampling Protocol 16 Equipment Calibration and Maintenance 17 Quality Control Procedures 17 Sample Custody 18 Analytical Procedures 18 Exterior Dust Sampling Protocol 19 Equipment Calibration and Maintenance 20 Quality Control Procedures 21 Sample Custody 21 Analytical Procedures 22 Sampling Protocol 23 Equipment Calibration and Maintenance 25 Quality Control Procedures 25 Sample Custody 26 Analytical Procedures 27 Data Processing and Management Procedures 28 IN Nk-11 M, I The objective of The Blood Lead Surveillance and Exposure of Young Children to Elevated Soil Lead at the Smuggler Superfund Site, Aspen, CO. Survey is to quantitatively characterize and assess the impacts of lead on human health. Well-designed, community- based blood lead screenings, in conjunction with a comprehensive environmental survey, provide the best means of identifying the health risks associated with lead. In order to verify that the data are accurate, certain quality indicators need to be developed and evaluated. The purpose of this quality assurance plan is to identify the quality indicators to be evaluated for each measurement, describe how the quality assurance data will be collected, and specify how each quality assurance measurement will be evaluated. Refer to The Blood Lead Surveillance and Exposure of Young Children to Elevated Soil Lead at the Smuggler Superfund Site, Aspen, CO. Survey Workplan for information regarding the study design and the corresponding sampling strategy. Much controversy exists regarding the risk to human health from metals in soil. In particular, there is uncertainty regarding the bioavailability of metals present in mining waste, and therefore, uncertainty regarding the potential risks of human exposure. In several studies conducted in mining and milling communities, weak indirect correlations between soil lead and the blood lead of young children have been seen, where soil lead is correlated with house dust lead and house dust lead is correlated with blood lead. In order to evaluate the health risk associated with exposures to lead, environmental and biological samples are collected. Information relative to the date and time of sample collection, responsible staff, and locations where samples were collected is recorded on the forms. Socio -demographic data as well as information about work, child's play, and recreational and occupational activities are recorded on data collection forms. (For examples of data collection forms, refer to the Survey Workplan. 1 OVERVIEW: Interior Environmental Sampling The environmental sample collection visit begins when the environmental team introduces themselves, and outlines for the resident the range of activities to be completed as part of the environmental visit. The consent form is reviewed with the study participant and the individual is asked to sign the form. Then, the environmental technician questions the resident to determine the location of each child's bedroom, the entrances most commonly used, and the rooms most utilized by the child/children. Dust samples are collected from these locations. Handwipe samples are obtained from the eligible children. A drawing of the interior floor plan is prepared and the sampling sites marked on the sketch. As part of the interior environmental visit, the following forms are completed: Consent Form Form 01 - Housing Survey Form 03 - Family Questionnaire Form 04 - Recruitment Form 05 - Interior Dust Sample Collection Form 10 - Environmental Questionnaire Form I I - Blood Sample Form 13 - Child Interview Form 12 - Adult Interview Form 19 - Handwipe Sample Collection OVERVIEW: Exterior Environmental Sampling Concurrent with the interior sample collection, a technician is collecting environmental samples outside the residence. Twelve (12) soil cores from the perimeter of the house are collected. Photographs of each sampling area are taken to document the location of each sample. A street dust sample and an exterior entry dust sample are collected. An evaluation of the exterior painted surfaces of the house performed. A drawing of the lot is prepared, siting the location of the house, entrances, driveway, gardens, play areas, bare sections of yard, and areas of sample collection. N As part of the exterior environmental visit, the following form is completed: Form 08 - Exterior Dust & Soil Sample Collection Once these samples are collected, as well as the interior environmental samples, closing comments are made to the family and the samples are returned to the field office. The blood lead sampling occurs in the home. Each family with a child less than 84 months of age is asked to participate in this screening. A pediatric phlebotomist collects the blood samples using pediatric collection supplies; sterile techniques are maintained at all times. Appropriate handling, storage, and shipping procedures are followed. The parent or responsible adult at the home is asked to sign a consent form. Information about where- the child spends his/her daytime hours and what daytime activities he/she performs is recorded on the child interview form. As part of the blood lead screening, the following form is completed: Consent Form Form 1I - Blood Sample Form Form 13 - Child Interview 3 PREPARATION FOR AN ENVIRONMENTAL VISIT: Environmental Sampling Bag: In preparation of an environmental visit, sampling bags are prepared that are specific to each household. Each sampling bag is labeled with a unique identification number, Two (2) sampling bags are prepared for each household: one bag is for interior sampling and the other bag is for exterior sampling. The contents of the sampling bags include all forms to be used for sample collection, as well as all of the sample collection containers. The interior environmental sampling bag contains materials necessary to complete the interior sampling. Custody seals are included to secure the interior sample and the the bag once sample and forms have been collected and returned to the sampling bag. The forms included in the bag consist of: Consent Form Form 01 - Housing Survey Form 03 - Family Questionnaire Form 04 - Recruitment Form 05 - Interior Dust Sample Collection Form 8 - Exterior Dust & Soil Sample Collection Form 10 - Environmental Questionnaire Form I I - Blood Sample Form 12 - Adult Interview Form 13 - Child Interview Form 19 - Handwipe Sample Collection An extra interior plot plan is also included in the sampling bag for revisions that may be necessary to the original plot plan. The date and time of the environmental sampling appointment are written in the allocated fields of each form. The interior sampling bag also contains the necessary sample collection supplies. These supplies include an interior dust cassette and a 125 ml Nalgene bottle in the event water collection is requested . Labels are IV affixed with scotch tape to the appropriate sample container. Plastic ziploc bags are also included for the handwipe samples. A handwipe sample collection bag is included for each child in the household, as well as one bag for the collection of the field blank associated with that residence. The child's name is written on the ziploc bag with a permanent -ink pen. The last item placed in the interior sampling bag is the collection nozzle that is utilized for the collection of the interior dust sample. The exterior environmental sampling bag consists of the, necessary forms and supplies for the exterior sample collection. Custody seals are included to secure the samples and the bag once all of the exterior samples and forms have been collected and returned to the sampling bag. There are only two (2) forms included in the exterior bag; the Exterior Dust and Soil Sample Collection Form 08 and the Exterior Plot Plan. The date and time of the environmental sampling appointment are written in the allocated fields of Form 08. A blank Exterior Plot Plan is included in the sampling bag. This second plot plan is available for use when mistakes are made to the first plot plan and a new plot plan needs to be sketched. A total of seven (5) mid-size ziploc bags are included in the exterior sampling bag. These are used to contain the various samples types that are to be collected at the residence plus several extra bags. The Dwelling I.D. and sample type are written on the outside of the ziploc bags with a permanent -ink pen for identification. 5 The interior surface dust sample consists of a composite of at least three sub -samples taken from the following areas in the residence: 1. a floor area near the most frequently used entrance; 2. a floor area in the room most utilized by the subject child; and 3. a floor area in the subject child's bedroom. Additional sub -samples may be added to the composite sample. These, sub -samples are taken from bedrooms occupied by additional subject children. If carpeting is not present in this area, the most likely place to find an adequate surface dust is the area immediately adjacent to the main entry door. The identification of sample sites from the most frequently occupied room and the child's bedroom is determined partly by the floor covering present in those rooms. If the floor is carpeted, an adequate sample can be collected readily from almost any pathway in the room. A pathway might consist of an area immediately inside of a doorway' into the room or an obvious pathway from one side of the room to the other. In rooms where there is no carpeting, the most likely place to find an adequate supply of surface dust is an area immediately adjacent to a wall. Very often on floors with smooth surfaces, dust migrates to the edges; therefore, this, generally, is the most likely place to collect the dust. Interior surface dust is collected by using a personal monitoring pump (2 L/min) connected by Nalgene tubing to a Gelman Sciences three-piece air monitoring cassette with a 0.8 micron poly cellulose acetate filter. A collection nozzle is connected to the air monitoring cassette by means of a short piece of Nalgene tubing. The collection nozzle is a piece of acrylic plastic tubing crimped on one end to form an opening of approximately 1.3 by 0. 1 cm. To facilitate the collection of the interior dust sample, a template is used. The inside of the template measures 25 cm by 25 cm. The dust sample I is collected by placing the template on the identified sampling area. The pump is then turned on and a visual check of the flow meter is made to, verify that the flow rate is 2.5 liters per minute. The collection apparatus is held at a 45' angle to the floor, surface and moved from one side of the template to the other. This sweeping motion is repeated in the same direction until the entire area has been "vacuumed" with the collection attachment. The procedure is repeated in a direction 6 900 from the, initial direction. A third coverage of the area is then completed in the same direction as the initial coverage. The rate of movement from one side of the template to the other should be approximately 11/2 - 2 seconds per stroke. Tile vacuuming process is timed, allowing one minute for each directional vacuuming, for a total of three minutes of vacuuming for each sub -sample. Once the sample is collected, the interior of the dust cassette is visually examined for sample content while the pump is still running. If there is only a very small amount of loose material, select another adjacent floor surface that has not been sampled and repeat the process using the same filter. This process is intended to double the surface area sampled to ensure that an adequate quantity of dust has been collected. As each sub -sample is collected, its location is indicated on the floor plan which is completed at the beginning of the visit. Care should be taken to record on the collection form the total number of areas sampled. After tile. sample is collected, the dust cassette is removed from the collection device and the end plugs are replaced. The dust cassette is then placed in its interior environmental sampling bag. The Interior Dust Sample Collection Form 05 is completed at the time the dust sample is collected. INTERIOR DUST: Equipment Calibration and Maintenance The sampling pump is calibrated to a flow of 2.5 liters per minute. The pump is equipped with a rotameter which is calibrated utilizing a bubble meter to ascertain the necessary flow rate by simply adjusting the set screw. The pump flow rate is checked and adjusted as part of the equipment check at the beginning of each day and at the time of the actual collection of each sample in a residence. The sampling pump is battery operated. The batteries are recharged on an overnight basis every third day. INTERIOR DUST: Quality Control Procedures Various measures are utilized to assess the reproducibility of the sample collection method. Field duplicates and field blanks are collected at 1.0% of the residences which are im randomly selected, The QC samples are collected at the time of the environmental visit. Field Blank: To collect the field blank, a dust cassette is attached to the sample pump and the pump is left to run for approximately three minutes. The collection nozzle should be pointed upward so that floor dust is not accidentally collected as part of the field blank sample. The field blanks are used to detect possible contamination of the collection equipment, collection media, and/or collection process. Field Duplicate: To collect the field duplicate, a template is placed on the surface adjacent to where the initial sample was taken; thus, it is a collocated sample. Utilizing the same collection protocol, a sample is taken. This sample is used as a measure of the reproducibility of the, sample collection process. The precision of the field duplicates is calculated as a relative percent difference (RPD). It is anticipated that the average RPD for the field duplicates should be within 20%. Field duplicates are also evaluated by their concentration difference. Since the samples are analyzed after completion of the sample collection phase of the study, it is virtually impossible to return to the site and re -sample when the RPD exceeds the prescribed standard (20%). Reference Standard (Field QQ: A third field-based, quality control measure is the insertion of reference standards into the sample stream. A NIST standard placed into an empty casette is inserted into the sample stream by the Project Coordinator at a rate of 10% of the total samples collected. These reference standards are provided by the University of Cincinnati Department of Environmental Health Hematology and Environmental Laboratory. The standards are labeled in the same way as, the samples collected from the residences and are blind to the laboratory. The accuracy of the quality control samples is calculated as percent recovery. The predetermined percent recovery standard is 80 - 120%. If the reference standards are not within the predetermined percent recovery standard, action is taken to discover possible sources of error. INTERIOR DUST: Sample Custody Once the interior dust sample is collected, a custody label is affixed to the dust cassette and placed in the environmental sampling bag which is sealed with another adhesive .1 custody label, and returned to the office. At this point, the sample is inspected by the custody officer and custody is transferred from the responsible environmental technician to the custody officer. This process involves signing over custody on the Interior Dust Sample Collection Form 05 and signing the release and receipt fields in the appropriate custody log book. Custody transfer occurs immediately upon arrival at the office. After the custody officer has accepted custody of the sample, it is prepared for shipment to the University of Cincinnati Department of Environmental Health Hematology and Environmental Laboratory. Custody sheets for shipping are completed. When the samples are ready for shipment, custody is transferred from the University of Cincinnati custody officer to the shipper (e.g. UPS). Upon its arrival at the University of Cincinnati, custody is transferred from the shipper to the University's receiving office personnel. The University's receiving office personnel then delivers the shipment to the analytical laboratory, where the laboratory custody officer assumes custody from the receiving office personnel. Please refer to the University of Cincinnati Department of Environmental Health Hematology and Environmental Laboratory QA/QC plan. This manual is available upon request. Vt WATER: Sampling Ptotocol The kitchen cold water tap is used to fill the 125 ml Nalgene collection bottle. When there is a problem collecting the sample from the kitchen tap, e.g. faucet drips, another main water source is chosen. The cold water tap is turned on for three (3) minutes and then shut off. The family is then asked to refrain from water usage and a "Do Not Use Water" sign is attached to the water source in the residence. In exactly thirty (30) minutes, a water sample is collected by opening the tap, collecting the sample without wasting any water, and then immediately shutting the tap off. When collecting the sample, contact between the mouth of the sample container and the faucet should not be made so as to avoid possible contamination. If for some unforeseen reason, a family member turns the water on before the test is complete, it is necessary to begin the process again. If the collection of the water sample is interrupted a second time, the sample collection form is completed and the actual time elapsed before the sample collection is recorded. The Water Sample Collection Form 06 is completed at the time the water sample is collected. Water samples are only collected upon request. Bottles contain 0.65 ml of ultra-pure concentrated nitric acid acidified to a pH less than 2. This minimizes, precipitation and preserves the sample for analysis. Once the sample is collected, it is agitated, sealed with a custody seal, and stored in a secure location. The Water Sample Collection Form 06 is completed by the laboratory technician and then filed with the other environmental forms for that residence. Various measures are utilized to assess the reproducibility of the sample collection method. Field duplicates and field blanks are collected at 10% of the residences which request water to be sampled. The QC samples are collected at the time of the environmental visit. Field Blank: To collect the field blank, the water collection bottle is set adjacent to the sink from which the sample is being taken. The field blank sample is left open to the environment during the collection of the water sample; the lid is placed top down on a 10 counter top to avoid possible contamination from dust particles. Once the water sample is collected, the field blank sample is capped and put in the bag with the remaining samples. Upon return to Cincinnati, the field blank bottle is filled with deionized water and 0.65 ml of ultra -pure concentrated nitric acid. The field blanks are used to detect possible contamination in field sampling due to the collection equipment or process. Field Duplicate: The field duplicate is collected according to the protocol previously described. Once the first sample is collected, the cold water tap is opened for three (3) minutes. Then, it is shut off and the family is again instructed to not utilize any water source in the house. After thirty (30) minutes, the sample is collected by opening the tap, collecting 125 ml of water without wasting any sample, and then immediately shutting off the tap. This sample is used as a measure of the reproducibility of the sample collection process., The precision of the field duplicates is calculated as relative percent difference (RPD) and the difference between duplicates. The average RPD for the field duplicates should be within 20%. If the field duplicates are not within the predetermined RPD standard of 20%, action is taken to discover possible sources of error. Since the samples are analyzed after completion of the sample collection phase of the study, it is virtually impossible to return to the site and re -sample when the RPD exceeds the prescribed standard. Reference Standard (Field Q.C.): A third field-based, quality control measure is the insertion of reference standards into the sample stream. Double distilled water spiked with a NIST standard is inserted into the sample stream by the Project Coordinator at a rate of 10% of the total samples collected. Reference standards are provided by the University of Cincinnati Department of Environmental Health Hematology and Environmental Laboratory. The standards are labeled in the same way as the samples collected from the residences and are blind to the laboratory. The accuracy of the quality control samples is calculated as percent recovery. The predetermined percent recovery standard is 80 - 120%. If the reference standards are not within this predetermined standard, action is taken to discover possible sources of error. 11 Once the water sample is collected, it is affixed with a custody sea] and placed in the environmental sampling bag, which is sealed with an adhesive custody label and returned to the office. At this point, the sample is inspected by the custody officer and custody is transferred from the, responsible environmental technician to the custody officer. This process involves signing over custody on the Water Sample Collection Form 06 along with signing the release and receipt fields in the appropriate custody log book. Custody transfer occurs immediately upon arrival at the office. The sample is prepared for shipment to the University of Cincinnati Department of Environmental Health Hematology and Environmental Laboratory. Custody sheets for shipping are completed. When the samples are ready for shipment, custody is transferred from the University of Cincinnati custody officer to the shipper (e.g. UPS). Upon its arrival at the University of Cincinnati, custody is transferred from the shipper to the University's receiving office personnel. The University's receiving office personnel then delivers the shipment to the analytical laboratory, where the laboratory custody officer assumes custody from the, receiving office personnel. WATER: Analytical h-ocedures Please refer to the University of Cincinnati Department of Environmental Health Hematology and Environmental Laboratory QA/QC plan. This manual is available upon request. 12 HANDWIPE'. Sampling Protocol Collection of the hand dust samples is done at the conclusion of each home visit. Preliminary data indicate that hand dust equilibrates with a given environment within two (2) hours. The environmental technician is to prevent, if possible, the washing of the child's hands during the visit prior to the collection of the handwipe sample. The environmental technician collecting the hand dust samples, first, cleans his/her own hands with a disposable wipe from a separate container of wipes kept for this purpose before touching the gloves or other equipment. Next, gloves are donned and the work surface area cleaned well using clean disposable wipes. At each residence, a field blank is collected first. To accomplish this task, six (6) wipes are removed from the container, handled to simulate wiping a child's hands, and then placed in a pre -labeled bag. Both hands of the subject/participant are wiped according to a standard procedure. The dust on the child's hands is sampled by wiping each hand of the child with three separate disposable wipes. All surfaces of the hand, front and back and up to the wrists, are wiped thoroughly with each of the three wipes. The wipes, totaling six (6) from each child, are deposited in a pre -labeled, sealable bag for transport back to the office. The lot number from the bottle of handwipes, used for sample collection is written in permanent -ink pen on the outside of the ziploc bag. The brand of disposable wipes used is Walgreen's Brand Wet - Wipes. HANDWIPE: Equipment Calibration and Maintenance The University of Cincinnati Department of Environmental Health Hematology and Environmental Laboratory supplies the study with handwipes. It is best to utilize handwipes from the same lot number throughout the entire sample- collection phase of the study. For this reason, the lot number of the wipes used during the sample collection is recorded on the Handwipe Sample Collection Form 19. The laboratory retains bottles of handwipes from the same lot number and prepares their standards and blanks utilizing the same lot number as was used to collect the samples being analyzed. The analytical laboratory is aware of the appropriate lot numbers because it is on the outside of each handwipc sample bag written in 13 permanent -ink pen. I-IANDWI PE: Quality Control Procedures Field Blank: A field blank is collected at each residence where a handwipe sample is collected. The field blanks are used to detect possible contamination of the collection equipment or process that occurred during the field sampling. Field Duplicate: No field duplicates are collected since both hands of the subject participant are, sampled at the time of the environmental visit. Reference Standard (Field QQ: Wipes are spiked with a known amount of NIST standard and are inserted into the sample stream by the Project Coordinator at a rate of 10% of the total samples collected. Once the hand dust samples are collected, the sample bags are affixed with a custody seal placed in the environmental sampling bag, which is sealed with an adhesive custody label and returned to the office. Upon returning to the office, the responsible environmental technician matches each handwipe sample with its corresponding Handwipe Sample Collection Form 19,. Then, he/she initials and dates the custody seal specific to the sample and staples it to the bag. At this point, the sample is inspected by the custody officer and custody is transferred from the responsible environmental technician to the custody officer. This process involves signing over custody on the handwipe Sample Collection Form 19 along with signing the release and receipt fields in the appropriate custody log book. After the custody officer has accepted custody of the sample, it is prepared for shipment to the University of Cincinnati Department of Environmental Health Hematology and Environmental Laboratory. Custody sheets for shipping are completed. When the samples are ready for shipment, custody is transferred by the University of Cincinnati custody officer to the shipper (e.g. UPS). Upon its arrival at the analytical laboratory, custody is accepted from the shipper to the University's receiving office personnel. The 14 University's receiving office personnel then delivers the shipment to the analytical laboratory, where the laboratory custody officer assumes custody from the receiving office personnel. Please refer to the University of Cincinnati Department of Environmental Health Hematology and Environmental Laboratory QA/QC plan, This manual is available upon request. 15 SOIL: Sampling Protocol One soil type is collected at each residence. This is a composite perimeter sample. Soil samples are collected with a coring device. The device is used in either of two ways. There is a "T" handle which can be attached to the top of the coring device allowing the operator to twist the coring tool, pushing it into the ground; in this way, the cutting edge of the soil corer cuts through roots and packed earth. The other method involves attaching a hammer device to the top of the coring tool. To utilize the coring tool in this manner, the hammer device is first attached to the top of the coring tool and the tool is placed on the ground where the sample is collected. The hammer is then raised and allowed to fall while it is guided by the operator's hands. This method is the most appropriate if the soils are of a compacted nature. At each residence occupied by a participating family, a composite perimeter soil sample is collected from the four sides of the residence. Three sub -samples are collected from each side where soil is present. The samples are collected at a distance of three feet from the exterior wall of the residence. Spacing along a side depends upon the position of sidewalks, vegetation, or other obstacles, If there is a sidewalk along an entire side of a house, the sample is collected along the edge of the sidewalk allowing for the least deviation from the designated three-foot line. These perimeter samples are collected by driving or pushing the coring tool into the ground approximately 2 to 21/2 inches. The tool is then moved gently from side to side, loosening the plug of earth, and the coring device is pulled from the ground. The soil sample is pushed by means of a pencil or finger so that the upper part of the soil plug lies between the 2 cm marks present on the coring device. The top 2 cm, of the soil sample are cut from the core with a spatula and transferred to a pre -labeled sample bag. All twelve (12) perimeter sub -samples are collected in this manner. The soil is placed in bag that is pre -labeled with the Dwelling ID and soil type using a waterproof, permanent -ink pen. Upon completion of the soil collection, the samples are brought back to the field office. 16 SOIL: Equipment Calibration and Maintenance None of the soil sampling equipment requires calibration. Between samples, and at the end of the day, the soil corers are thoroughly cleansed with wet wipes and then dried with clean paper towels. 1� 1, � T I I Various measures are utilized to assess the reproducibility of the sample collection method. Field duplicates are collected at 10% of the residences which are randomly selected. The QC samples are collected at the time of the environmental visit. Field Duplicate: A field duplicate soil sample is collected adjacent to the previously collected soil sample; therefore, it is a collocated sample. The same collection protocol is utilized. These samples are used as a measure of the reproducibility of the sample collection process. The precision of the field duplicates will be calculated as relative percent difference (RPD) and concentration differences. It is anticipated that the average RPD for the field duplicates should be within 20%. If the field duplicates are not within the RPD of 20%, action is taken to discover possible sources of error. Since the samples are analyzed after completion of the sample collection phase of the study, it is virtually impossible to return to the site when the RPD exceeds the prescribed standard. Reference Standard (Field QC) : A second field-based, quality control measure is the insertion of reference standards into the sample stream. Standards (quantified by a number of labs and methods) are inserted into the sample stream by the Project Coordinator at a rate of'10% of the total samples collected. These reference standards are provided by the University of Cincinnati Department of Environmental Health Hematology and Environmental Laboratory. The accuracy of the quality control samples is calculated as percent recovery. The predetermined percent recovery standard is 80 - 120%. If the percent recovery is not within this predetermined standard, action is taken to discover possible sources of error. 17 SOIL: Sample Custody Once the soil samples are collected the bag is affixed with a custody seal and placed in the environmental sampling bag, which is sealed with an adhesive custody label and returned to the office. Upon their arrival to the office, the responsible environmental technician verifies the sample identity against its corresponding Exterior Dust and Soil Collection Form 08. At this point, the samples are inspected by the custody officer and custody is transferred from the responsible environmental technician to the custody officer. This process involves signing over custody on the Soil and Exterior Dust Sample Collection Form 08, along with signing the release and receipt fields, in the appropriate custody log book. Custody transfer occurs immediately upon arrival at the office. Once the custody officer has accepted custody of the sample, it is prepared for shipment to the University of Cincinnati Department of Environmental Health Hematology and Environmental Laboratory. The soil samples specific to a residence are kept together as a residential packet. Custody sheets for shipping are completed. When the samples are ready for shipment, custody is transferred from the University of Cincinnati custody officer to the shipper (e.g.. UPS). Upon its arrival at the University of Cincinnati, custody is transferred from the shipper to the University's receiving office personnel. The University's receiving office personnel then delivers the shipment to the analytical laboratory, where the laboratory custody officer assumes custody from the receiving office personnel. SOIL: Analytical Procedures Please refer to the University of Cincinnati Department of Environmental Health Hematology and Environmental Laboratory QA/QC plan. This manual is available upon request. 18 F 1": U 0, If Two composite exterior dust samples are collected: an entry sample and a street curb sample. The entry sample is a composite sample from two or three of the most used entrances; generally, the front and side or rear entrances to the residence. In the case of apartment buildings, the study participants are asked which entrances are most commonly used; samples are collected atthose designated entrances. The entry dust sample is collected by first selecting an area with the heaviest loading of dust within six (6) feet of the door, Once the area of heaviest loading closest to the entry has been identified, the template, measuring 6" by 24", is placed over the area and the perimeter of the template is drawn on the surface with carpenter's chalk. The template is removed and the dust is loosened, if necessary, by means of a stiff bristled brush. Once the material is loosened, it is brushed into a pile within the defined area with a paint brush. This pile is then scooped up with a paint brush and scoop, and deposited in the pre -labeled sample bag. After the bulk of the material is collected in this fashion, the portable vacuum cleaner is used to vacuum the area defined by the chalk lines. The first step in using the vacuum is to place a piece of filter material in the collection cassette. With the filter in the cassette, the hose is connected to the cassette, the collection attachment is connected to the hose, and the vacuum is turned on. The sample is collected by passing the collection nozzle across the designated surface area from one side to the other along the long axis of the sample area at the rate of three to four seconds per pass. Repeated passes are made at the same rate until the entire area is vacuumed one time. The collection process is then repeated in a direction 90' to the initial direction. A final pass is made in the same direction as the initial collection. The rate of movement of the collection nozzle across the sampling area is constant throughout the process of sample collection. When the sampling area contains a large amount of dust, the filter can become clogged prior to completion of sample collection. Visual checks of the filter are made occasionally during the collection process and, if it appears the filter is covered with dust, the collection cassette should be emptied. The vacuum is turned off and the hose and the M collection cassette are removed from the vacuum cleaner. The contents of the cassette are deposited into the sample bag without taking the cassette apart; tapping on a hard surface dislodges most of the material from the filter surface. The sample collection process is continued beginning at the point where the process was previously interrupted. The remaining sample collected is transferred to the same sample bag. Once the composite entry dust sample is collected, the hose is cleaned in the following manner. The vacuum cleaner is allowed to remain running and the hose is lifted into a vertical position above the vacuum. With the vacuum running, the operator taps the side of the hose with the paint brush, tapping from the highest extension point of the hose to the lowest, three separate times. This process dislodges most of the dust from the sides of the hose. Upon completion of this process, the filter cassette contents are deposited carefully so as to not lose any sample into the pre -labeled sample bag. The dust remaining in the collection device is brushed into the sample collection bag. The filter cassette is cleaned using wet -wipes and then allowed to air dry before the collection of the composite street dust sample. The paint brush and the collection nozzle are used only once; a clean brush and nozzle are used to complete the collection of the street dust sample. The street curb composite sample consists of a sub -sample collected from the intersection of the driveway and the street curb and a sub -sample from the curb area closest to the sidewalk leading to the front door. The street dust sample is collected utilizing the exterior entry dust collection protocol previously described. As the final step in the collection of the exterior dust sample, the responsible environmental technician verifies that all the data are recorded on the Exterior Dust & Soil Sample Collection Form 08. The vacuum and other equipment are then packed to be transported to the office for cleaning. EXTERIOR DUST: Equipment Calibration and Maintenanc_-i None of the exterior dust sampling equipment requires calibration. The brush and collection nozzle are used only once per household. At the end of the day, the equipment is washed thoroughly and left to dry overnight. ME EXTERIOR DUST: Quality Control Procedures Various measures are utilized to assess the reproducibility of the sample collection method. Field duplicates and reference standards are collected at 10% of the residences which are randomly selected. The QC samples are collected at the time of the environmental visit. Field Duplicate: Duplicate exterior entry dust and street dust samples are collected according to the standard exterior dust sample collection protocol; the samples are collected adjacent to the areas where the initial samples are taken. The duplicate samples are used as a measure of the reproducibility of the sample collection process. The precision of the field duplicates is calculated as relative percent difference (RPD) and concentration difference. It is assumed that the average RPD for the field duplicates should be within 20%. Since the samples are analyzed after completion of the sample collection phase of the study, it is virtually impossible to return to the site and re -sample when the RPD exceeds the prescribed standard. Reference Standard (Field QQ: The insertion of reference standards into the sample stream is another quality control measure. Standards (quantified by a number of tabs and methods) are inserted into the sample stream by the Project Coordinator at a rate of 10% of the total samples collected. These reference standards are provided by the University of Cincinnati Department of Environmental Health Hematology and Environmental Laboratory. The standards are labeled in the same way as the samples collected from the residences and are blind to the laboratory. The accuracy of the quality control samples is calculated as percent recovery. The predetermined percent recovery standard is 80 - 120%. if the reference standards are not within the predetermined percent recovery standard of 80 - 120%, action is taken to discover possible sources of error. EXTERIOR DUST: Sample Custody Once the exterior dust samples are collected, they are affixed with a custody label and placed in the environmental sampling bag, which is scaled with another adhesive custody label and returned to the office. Upon their arrival to the office, the responsible 21 environmental technician verifies each sample log number against the corresponding identifiers on the Exterior Dust and Soil Collection Form 08. At this point, the sample is inspected by the custody officer and custody is transferred from the environmental technician to the custody officer. This process involves signing over custody on the Exterior Dust and Soil Collection Form 08 along with signing the release and receipt fields in the appropriate custody log book. Once the custody officer has accepted custody of the sample, it is prepared for shipment to the University of Cincinnati Department of Environmental Health Hematology ,and Environmental Laboratory. The dust samples specific to a residence are kept together as a residential packet. Custody sheets for shipping are completed. When the samples are ready for shipment, custody is transferred from the University of Cincinnati custody officer to the shipper (e.g. UPS). Upon its arrival at the University of Cincinnati, custody is transferred from the shipper to the University's receiving office personnel. The University's receiving office personnel then delivers the shipment to the analytical laboratory, where the laboratory custody officer assumes custody from the receiving office personnel. Please refer to the University of Cincinnati Department of Environmental Health Hematology and Environmental Laboratory QA/QC plan. This manual is available upon request. 22 BLOOD: Sampling Protocol Proper blood collection techniques are critical to ensure that the sample is not contaminated. This begins with proper preparation of the subject for sample drawing. The skin is thoroughly cleansed before sampling. Blood collection equipment and supplies are stored and set up in a manner that will keep them free of dust and airborne contaminants. Furthermore, blood tube (vacutainer) stoppers are never removed except by trained laboratory staff. Samples are clearly labeled with the subject's name, date, and laboratory sample number. EDTA is used as the anticoagulant in the vacutainer tubes. These tubes come in boxes and are covered with Kirnwipes once the box is opened, in order to protect the tops from becoming contaminated. Kimwipes, a lint free cloth, are used to cover tubes, place blood collection supplies on, or used whenever there is a need to protect equipment from contamination. Venipuncture samples are drawn using a 23 gauge butterfly, needle, and syringe. The butterfly apparatus is the safest collection method with children, giving the phlebotomist much greater flexibility to deal with their movements. The procedure begins by setting out all of the blood collection supplies that are needed such as alcohol pads, gauze sponges, vacutainer tube, butterfly, and syringe. The phlebotomist places the subject's name, dwelling ID and the sample date on the label with a permanent -ink pen. The phlebotomist's hands are washed well with soap and water and gloves donned. A tourniquet is placed around the child's arm and the puncture area prepared by briskly scrubbing the area twice with the alcohol pads, and wiping the area with a gauze sponge after each scrub. Once the needle is in the vein and blood is seen in the butterfly tubing, the syringe is aspirated gently so as to prevent the cells from lysing. The tourniquet is removed during this process and the needle extracted from the vein. The phlebotomist or parent holds a clean gauze sponge on the puncture wound. The vacutainer tube is then filled by puncturing the top and gently releasing the blood into the tube. Immediately, the tube is inverted several times and either the sample is placed covered on an orbital mixer for about five (5) minutes, or inverted very gently about twenty (20) times by hand. The puncture area is covered by a band-aid. M The disposable gloves, along with all of the other blood collection and processing equipment, are removed and disposed of in the biohazard container. A fingerstick sample is collected when the parent or child refuses a venipuncture sample or when the parent approves a fingerstick after the failure of a venipuncture attempt. The procedure begins by setting out all of the blood collection supplies that are needed such as alcohol pads, gauze sponges, capillary tubes, and a lancet. The phlebotomist places the subject's name, dwelling ID and the sample date on the label with a permanent -ink pen. The phlebotomist's hands are washed well with soap and water and gloves are donned. Then, she/he grasps the child's hand so that her/his thumb is across the top of the child's fingers. The child's hand is held so that his/her palm faces himself/herself. The fingerstick should be completed on either the child's middle or ring finger. To cleanse the finger, an alcohol sponge is briskly rubbed across the child's, fingertip for approximately twenty (20) seconds; the scrubbed area is then dried with a gauze sponge. The finger is pricked with a lancet slightly to the left of center; a dry gauze pad is used to wipe off the first drop of blood. While the phlebotomist holds a 100 jul lead-free capillary tube at the double black band, the child's finger is gently squeezed towards the fingertip, allowing the blood to fill the capillary tube just to the black line. If air bubbles appear in the sample, it is possible to eliminate them by pointing the capillary tube slightly downward. Once the capillary tube is filled to the black line, it is tipped slightly back and forth to completely mix the sample with the EDTA in the capillary tube. EDTA is present within the entire capillary tube but the proper dilution of 100 Itl of blood with EDTA occurs between the black filling lines present on the capillary tube. For this reason, it is important that the blood sample not collect past the black filling line. If this occurs, the blood sample will not be properly diluted. When the sample has been properly mixed with the EDTA, the tube is tipped slightly upward to allow air to enter the collection end; then, the ends are capped. To verify that the blood sample is contained within the capillary tube in an airtight manner, the tube can be held upward. This procedure is repeated with a second capillary tube. Once both samples are collected, they are placed in their ESA "shock tube" to prevent breakage and contamination. A Kimwipe is placed inside the ESA "shock tube" to keep the capillary tubes separate and secure. A label 24 is placed on the outside of the ESA "shock tube" and the sample is placed in the refrigerator until shipment to the analytical laboratory. BLOOD: Equipment Calibration and Maintenance None of the blood collection equipment requires calibration. It is important that all equipment be maintained in a sterile manner, All sampling equipment are covered with Kimwipes to protect the equipment from dust and other airborne contaminants. Twice daily, once in the morning and at the end of each clinic day, the refrigerator temperature is verified and recorded. Depending upon the results, any necessary adjustments are made to maintain the refrigerator at 38° F. At any time when the clinic staff is not present, security labels are placed on the refrigerator. The labels are strategically placed to ensure the security of all of the blood samples collected since the last shipment,. The refrigerator log documents all security and temperature checks and is maintained by the clinic staff. BLOOD: Quality Control Procedures Various measures are used to assess the reproducibility of the sample collection method. Field duplicates are collected and reference standards are inserted at a rate of 10% of the total number of blood samples collected. A previously determined number of syringes, vacutainer tubes and butterflies are set aside by the analytical laboratory to be lot tested. This involves analyzing the supplies by lot numbers to verify that contamination cannot be attributed to the supplies being utilized in the sample collection phase of the study. Field Duplicate: Field duplicates are collected from every other subject. Two 2 ml blood samples are drawn from the subject. One vacutainer is labeled with the actual subject information; the duplicate sample is assigned a fictitious name, date of birth, and Dwelling ID, ensuring the laboratory is blind to the source of the sample. The precision of the field duplicates is calculated as a relative percent difference (RPD) and concentration difference. Since the samples are analyzed after completion of the sample collection phase of the study, it is virtually impossible to re -sample when the RPD exceeds the prescribed standard. P& Reference Standard (Field QQ: QC samples from the Centers for Disease Control (CDC) are inserted into the sample stream every fifth sample. A fictitious name, date of birth, and Dwelling ID are assigned to each CDC reference sample. The accuracy of the quality control samples is calculated as percent recovery. The predetermined percent recovery is, 80 - 1201. If the reference standards are not within this standard range, action is taken to discover possible sources of error. Interlaboratory Comparison - A portion of at least 10% of the samples will be sent to CDC (Atlanta, GA) for comparison. Precision will be calculated as the concentration difference. An entry is recorded in the laboratory custody book for, each blood sample collected. The custody book contains pertinent information, such as sample log number, Dwelling ID, the responsible phlebotomist's initials, custody signatures, sample collection date, and shipment dates. The blood samples are stored in a designated refrigerator maintained at 38' F. A refrigerator log is maintained which documents the refrigerator temperature during the clinic operation as well as the total number of samples collected each day. Also, the total number of samples being stored in the refrigerator is maintained on this form. Each day the refrigerator is locked and adhesive custody seals are placed on the door to ensure sample security. A laboratory custody sheet is also completed that contains the information regarding the laboratory sample number and subject's name. This laboratory custody sheet is maintained for the University of Cincinnati's Hematology and Environmental Laboratory and, upon sample shipment, it will accompany the samples. Two copies are made of this custody sheet and maintained as a record of the sample shipment. The blood samples are placed in cardboard racks; wipe -ails are wrapped around the box of blood samples to prevent the blood samples from freezing during shipment. Frozen blue -ice packs are packed in the mailing coolers; custody seals and "biohazard" stickers are placed on the outside of the coolers. The cooler is placed inside a shipping box which is addressed for overnight shipment to the 26 analytical laboratory. BLOOD: Analytical Procedures Please refer to the University of Cincinnati Department of Environmental Health Hematology and Environmental Laboratory QA/QC plan. This manual is available upon request. 27 DATA PROCESSING AND MANAGEMENT PROCEDURES Numerous review and data processing procedures are used to ensure the accuracy and validity of the data recorded on data collection forms. All study personnel, including clinic, laboratory, and field staff, are trained to complete data collection forms according to, standardized procedures. Accuracy, legibility, and completeness, critical characteristics of good data collection, are stressed and continually assessed throughout the study. Once the forms have been completed, they are reviewed for legibility and completeness. Any discrepancies that are discovered are returned to the person responsible for data collection for correction. Checks for internal consistency are developed for each form. A local computer database of study participants is developed and maintained. Once the forms are reviewed and determined to be accurate, they are entered into a Macintosh - compatible data management system for storage and retrieval. The data are entered twice and the two entries are compared for discrepancies. When the comparison between the two entries match, an error report consisting of all of the information present on the form is prepared. The error checking process requires two (2) people, One person reads the information on the actual form and the other listens, verifying the information on the error check report. Any discrepancies are marked in red ink and flagged so that the Project Coordinator can make the necessary changes to the database. This process continues until the error check report correctly matches the form. In addition, error checking routines using software logic are developed for each form to check for such problems as out of range entries. In time, data files are merged to develop working data sets for analysis. Test merges of the data are conducted to identify problems which prevent successful merging of the data files. Error corrections to the data collection forms are made and then the necessary corrections are made to the database. Test merges of the data are continued until successful merging of the data files occurs. Univariate analyses of the frequency distributions of exposure and outcome variables are reviewed before any statistical analyses are performed. This process also aids in the discovery of possible spurious outliers or errors that are not identified by one of the M