Lessons Learned

Learning from experience is an essential component of public health. The Four Corners States Biomonitoring program is collecting 'lessons learned' during all stages of the program. The purpose of this page is to share these experiences so other programs may learn from our experiences and inform similar efforts.

Implementation

Colorado's Pediatric Biomonitoring in the San Luis Valley

Successes in the Colorado's Pediatric Biomonitoring Project in the San Luis Valley

Over the course of the 3 year consortium, we have recruited 200 children from all over the San Luis Valley with plans to recruit another 200 over the rest of Year 3. We have successfully, recruited and interviewed 200 sets of parents and children aged 3 to 13 years of both genders and multiple racial and ethnic backgrounds. We have completed analysis on 160 urine and water samples and have mailed these results back to parents (in English or Spanish). Lastly, we have identified all elevated urine and water results and engaged with the parent of each child and discussed ways in which they can reduce exposure in their children. We have only had 5 circumstances of actionable levels (lead, arsenic in urine and arsenic and manganese in water). We have also set up a follow-up protocol for all children with elevated levels (> 95% of NHANES) and have started recontacting and scheduling children for this. The success in the study protocol is grounded in the established collaboration among local Colorado experts, researchers, and health care providers and the basis of the study being rooted in a regional consortium.

Support from Local Collaborations

  1. Expert Advisory Panel: Composed of 2 medical toxicologists, 2 emergency clinicians with expertise on environmental events and children, 1 local environmental health official, and 1 expert in exposure assessment. When elevated levels have occurred especially the action level results, the EAP has been quick to provide expert advice on how to engage with parents regarding potential clinical implications for exposure levels and at what point should there be an official public health intervention or notice.
  2. Local health care providers: We are currently recruiting all children through the two medical practices in the San Luis Valley that sees children (SLVHealth and Valley Wide Health). The SLVHealth clinic is a pediatric clinic that sees 75% of the children in the SLV and the chief medical officer fully supports the project. Additionally, the three pediatricians at the clinic are engaged with the study, actively reviewing results, and supporting the recruitment. They are also interested in continuing this work long term through their clinic in the form of a biomonitoring study linked to health effects and a concurrently run intervention for reduction in exposure.
  3. Laboratory and University collaboration: By establishing a working relationship between the state laboratory and researchers at the University, we have laid a solid foundation for continued collaborative work in relevant research areas including metals and health outcomes.
  4. Regional collaboration with other state laboratories and health departments: The collaboration between the four regional states has provided a strong support network that is desperately needed in research settings, but not always present. Examples of this include:
    • A larger knowledge base available to support both epidemiologist and chemists.
    • Shared resources for more efficient completion of necessary research components.
    • Coverage when laboratory instruments are being repaired or ordered (sending samples to another state for analysis when local state lab has a down instrument).
    • Shared experiences (successes and failures) among epidemiologists to prevent re-inventing the wheel and avoiding error replication.

Role of CLIA

The Role of the Clinical Labratory Improvement Act (CLIA) Regulations

Background: The Clinical Laboratory Improvement Amendments (CLIA) of 1988 establishes regulatory performance standards for laboratories performing tests for diagnosis, preventive screening, or treatment management of diseases and impairments. One CLIA standard (493.1291(f)) states that test results can only be released to an authorized person. An “authorized person” is typically defined as the patient’s health care provider.

When the 4CSBC organized, except for the Colorado program, the state projects did not involve a health care provider. Although the four state laboratories decided to adhere to CLIA quality improvement standards, because the purpose of the project was to conduct population surveillance and not individual diagnosis, the tests results were not considered subject to CLIA regulations. The 4CSBC participant consent form included language that indicated that the tests were not diagnostic. The 4CSBC state project staffs were conscientious to ensure that participants understood this limitation to the results as the samples were collected.

The 4CSBC projects returned testing results directly to the participant along with NHANES comparison levels and a number of fact sheets that described the results and ways to reduce exposure. Within the return package was a recommendation that participants seek follow-up testing if they had concerns regarding their individual results. A survey of other state biomonitoring projects found that this methodology was typical.

The project states decided to use the NHANES 95th percentile as a comparison value and to identify participants with high values. Occasionally, a participant would have a result above the NHANES 95th percentile value. In those cases, the project epidemiologist would make a personal phone call to the participant to provide an “early warning” of the result, describe what it might mean, discuss ways of reducing exposure and answer questions.

Problem: A concern over this logic was raised by one of the state laboratory’s in-house CLIA inspectors. While the regional CLIA inspector agreed with the overall logic of the projects approach, two concerns were raised by some that needed to be addressed:

  • The act of encouraging a participant seek follow-up testing could be construed as a treatment management action covered by CLIA.
  • It is conceivable that a health care provider could initiate a treatment based on the results and the NHANES comparison value without fully understanding the nature of the project, the test results or the NHANES comparison value.

Remedy: To solve these concerns, the project:

  • Incorporated specific language in the cover letter of the results that specifically stated that the results were not diagnostic and “should not be used for clinical purposes.”
  • Provided the participants with a detailed description of the NHANES comparison values.
  • Worked with state poison control centers to provide medical consultation to clinicians who may be approached by participants.

 

Developing Laboratory Capacity

Reorganizing Laboratory Resources

Reorganization of Laboratory Resources and Increased Communication to Meet Grant Deliverables

In the spring of 2016 the Colorado Department of Public Health and Environment was falling behind on completion of method validations for methods needed for the analysis of anticipated biomonitoring urine samples. The single chemist funded by the biomonitoring grant was unable to keep up due to other ICP-MS metals analysis, other responsibilities and validations associated with the Public Health Emergency Preparedness (PHEP - CDC) LRN-C and Food Emergency Response Network (FERN – FDA) grants also in place at the laboratory. Additionally, the program was in the process of filling a vacancy for a chemist designated as a Mass Spectrometry Specialist.

To aid in the organization and prioritization of project goals a specific 4CSBC weekly meeting was established to monitor progress, determine schedules and resources needed. Increased communication with the field epidemiologist was also initiated to keep up to date on laboratory status. It was determined early on in these discussions that significant in kind support was going to be required to be successful. The newly hired chemist, management and an additional 3 technical FTE were assigned to assist with the project “in kind” in order to allow for the completion of the urine metals, urine mercury and urine 2,4-DCP and 2,5-DCP method validations. In kind staff track work time on the 4CSBC project on a spreadsheet, to date 579 hours and $28,587.87 of support has been provided to the 4CSBC project from 5 FTEs.

The use of additional staff greatly increased the pace of method validations. The workload for the urine and water metals testing was distributed between 3 ICP-MS instruments and 1 ICP. The ICP and one ICP-MS were dedicated to water metals analysis, the urine metals and urine mercury were each conducted on dedicated ICP-MS systems. ELISA and LC-MS/MS were also in use for creatinine and 2,4-DCP and 2,5-DCP analyses respectively. Once samples started to arrive in April a tracking spreadsheet was created as a visual aid to the status of each sample. The sheet, accessible to all staff, included the laboratory number and columns for the status of Metals, Mercury, Creatinine, As Speciation, 2,4/2,5-DCP, Pthalate and Pyrethroid shipment and reporting dates. Sample status was indicated by a date and color corresponding to Red: incomplete, Yellow: in progress, Blue: re-analysis/confirmation needed and Green: completed.

The validations for creatinine, urine metals, urine mercury and 2,4-DCP and 2,5-DCP are complete, the CDPHE laboratory has also completed the analysis of more than half of the 151 urine samples collected this year and is ready to accept DCP samples from the other participating states. The weekly meetings have now turned into a short monthly gathering to discuss project needs and status. The in kind staff support continues on an as needed basis and the need is anticipated to decrease as routine sample analysis falls into place.

The implementation and validation of new methodology on difficult matrices is time consuming. Staff needs to be dedicated to complete these tasks in a timely manner. It may be necessary to assign tasks to other staff so the grant funded chemist can complete the work required. Frequent communication with all project staff is critical to maintain momentum and address resources needed for success.

A Culture of Collaboration

A Culture of Collaboration - The Value of a Strong Laboratory Network

Background: Over the three years of working together through monthly conference calls, face to face meetings, shipping samples to each other and trouble- shooting common laboratory problems, the Four Corners States Biomonitoring Consortium members have developed a culture of cooperation, openness, and flexibility which has helped the consortium overcome barriers. In addition, since all biomonitoring programs of the consortium states have built biomonitoring capacity upon the existing resources of their Public Health Emergency Preparedness (PHEP) Laboratory Response Network (LRN) Chemical Threat (CT) laboratories, a strong collaboration among chemists in the biomonitoring and CT laboratories have developed.

Problem and solution: On Nov 23, 2016 Utah’s CT laboratory received an unknown sample from their local emergency response coordinator. The sample was of potential threat to public and needed immediate attention. Utah’s chemists in the CT laboratory reached out to New Mexico’s chemist for guidance. New Mexico is Level 1 CT laboratory and had more experience with analyzing unknown samples, compared with Utah which has a Level 2 CT laboratory capacity. The guidance from New Mexico’s chemists allowed Utah’s chemists to correctly and timely identify the sample and respond to the emergency situation.

In another situation: May 1, 2017, Utah stepped in to help Colorado’s CT laboratory when Colorado’s laboratory had an unexpected problem with instrument used during an exercise conducted by the Center for Disease Control and Prevention (CDC) to assess laboratory readiness to respond to emergencies. The exercise is called Laboratory Response Network (LRN) Surge Capacity exercise. Colorado was picked as one of the states for the exercise. With instrument malfunctioning, Colorado reached out to Utah for assistance. Utah’s CT laboratory performed the LRN Surge Capacity exercise on behalf of Colorado, exhibiting a prompt collaboration and response from the states of the four corners states biomonitoring consortium (4CSBC).

The fact that most CT programs use the same equipment, instrumentation, and analytical methods, has helped in finding solutions to problems relating to analytical method performance. Examples being:

  1. The New Mexico Lab having a problem with selenium in urine detection and so shipped samples to Utah so as to maintain timely laboratory analysis.
  2. The Utah Lab having a problem with cadmium and manganese in urine detection and so shipped samples to New Mexico so as to maintain timely laboratory analysis.
  3. The Arizona Lab having difficulty in bringing online mercury in urine worked with the New Mexico and Utah chemists to troubleshoot a workable solution.
  4. Given the estimated low number of potential Arsenic samples above 50 ppb it was decided two laboratories with the capacity for Arsenic Speciation in Urine was redundant. Arizona took responsibility to provide the speciation testing for the consortium, this gave Colorado the opportunity to focus on both metals and 2.4-DCP and 2,5-DCP testing for their program and the other consortium states.

Conclusion: Chemists from Arizona, Colorado, New Mexico, and Utah have all been instrumental in each other’s day to day trouble shooting and method development. With the rapport states built over the past years, states have in turn become stronger CT laboratories.

 

Developing Epidemiology Capacity

Partnering with Existing Programs

Partnering with Existing Programs to Build Epidemiology Capacity

In order to develop epidemiology capacity, Arizona and New Mexico have paired with existing programs to expand their reach for biomonitoring. Both states have private well programs which host well water fairs in rural communities in which residents can bring samples of their water for free field testing. The residents also fill out brief surveys and can indicate whether they would like to be contacted for further testing. The biomonitoring program is able to use this information to contact potential participants. Because the people that are contacted have shown an interest in water quality and metals exposure, they have been very likely to volunteer to participate in the study.

In Colorado, the biomonitoring team has paired with children’s health clinics to recruit participants. Through the clinics, they are able to spread the word about having children tested for exposure to chemicals and to sign participants up to be tested. This has been a primary method of recruitment for the program.

In the face to face meetings the epi team has been able to discuss and develop deliverables for the program, including results return packets to send out to participants. While what works in one state does not always work in the other states, being able to discuss verbiage and necessary components for materials has been instrumental in product development.

In addition to the face to face meetings, the consortium uses a secure document repository to share documents. Included in this repository are standard operating procedures, templates, marketing materials, results returns, etc., used by each state. Also included in this repository are documents needed for reports and for IRB’s to simplify the process of reporting back and updating the IRB approvals. The existence of the repository has provided the consortium a document storage location for quick reference, as well as a place to go to get ideas for product development in the individual state.

Gold King Mine spill, 2015

Support and Actions during the Gold King Mine spill in 2015

On August 5, 2015, an attempt to alleviate water seepage from the entrance of the Gold King Mine in Colorado resulted in a blowout that released three million gallons of mine waste water and mobilized nearby tailings into the Animas River. The waste water and tailings contained high levels of heavy metals including arsenic, beryllium , cadmium, copper, iron, lead, and zinc. The Animus River connects with the San Juan River in northwestern New Mexico. From New Mexico, the San Juan River flows west through southern Utah until it drains into Lake Powell. Both the Animus and San Juan rivers have relatively elevated levels of these metals that are naturally occurring from the geology of the area. The Animus River, San Juan River, and Lake Powell are used for recreation during August. In addition, a number of municipalities and communities are located along San Juan River, the largest of which is Farmington in New Mexico. Some of these communities use river water as source water for domestic and agricultural needs.

Shortly after the breach , state health departments and state emergency management were made of aware of the event. Recreational use of the Animus and San Juan rivers was suspended for several weeks until the level of pollution had returned to pre-incident levels.

The emerging event of the Gold King Mine spill into the San Juan River was instrumental in stirring public interest in the biomonitoring program. In New Mexico, for example, the biomonitoring staff was able to leverage the public interest in the event to schedule a sampling collection in a community located near the river. This community had not previously been identified as a community of interest for testing. The Utah biomonitoring staff observed that participants were more interested in the quality of their ground water after the news of the spill had dispersed.

In addition to surveillance and targeted studies, one of biomonitoring’s primary goals is to respond to emerging events that could involve potential environmental exposures. This was a natural opportunity for the New Mexico and Utah programs to offer exposure assessment and private well water testing to the community. Beyond learning about their well water quality, residents also would have the chance to learn about their potential exposure to metals. It was emphasized to residents that the contribution of exposure (if any) from the event could not be determined.

Some states were able to leverage the use of media to engage with communities and identify potential participants. In Arizona, a representative from the department of health was interviewed on the local public radio station. As a result, the biomonitoring staff was contacted by 35 additional participants.

New Mexico’s program was featured in a local paper and as a result, they significantly increased their sample size. In Utah, sending out water results was helpful in developing community interest in biomonitoring and water quality. Through community websites and Facebook pages they were able to discuss their concerns and were able to contact us for further testing in their areas.

Some of the states are working with tribal leaders to expand testing capacity in rural reservation areas. In Utah, while recruiting participants in the southeast part of the state, the teams were made aware of a concern about heavy metal exposure in the Mountain Ute Tribe. By working with tribal leaders and the state Indian health specialist, they were able to establish a sampling event in the community. The event was well attended, the teams were able to discuss with participants their concerns for exposure to toxins, and were able to provide peace of mind to the residents about their level of exposure to heavy metals.

 

Participant Recruiting and Sampling

Private Well-Water Sampling Events as a Recruitment Method for Biomonitoring

Private well-water sampling events as a recruitment method for biomonitoring

Biomonitoring participant recruitment can be labor-intensive and time-consuming. With limited staff and funding we are always trying to explore and develop methods to help this process be as efficient and successful as possible.

The New Mexico Department of Health (NMDOH) Private Wells Program collaborates with the New Mexico Environment Department (NMED) Groundwater Water Quality Bureau to offer up to 10 water fairs per year in various communities throughout the state. During a water fair local residents can bring in a water sample from their private well for free field testing. The sample is tested for specific conductance, pH, fluoride, sulfate, iron, and nitrate, and screened for arsenic levels. To learn more about water fairs, visit https://nmtracking.org/water.

When residents bring in their water sample they provide basic information regarding their well construction (depth, casing material, age, etc.), and complete a pre-test survey. The survey asks questions such as participants’ previous testing practices, concerns, how they learned of the event, and if they would be interested in being contacted about future well-water-related studies in the area.

During the first two years of the Four Corners States Biomonitoring Consortium Program (4CSBC), New Mexico conducted studies to better understand potential exposures to metals associated with private well drinking water consumption, among other potential exposure sources in two separate communities (Year 1 – Community A, and Year 2 – Community B). In both cases the communities had hosted a previous water fair. The NMDOH Private Wells Program was able to provide a list of households who expressed interest in being contacted for future studies through the pre-test survey, 70 and 32 households, respectively for communities A and B.

We attempted to contact all individuals on these lists. Of the 70 households that we contacted with a phone call and mailing in Community A, 31 (44%) agreed to participate. Of the total Community A participants, 50% were from a household which was contacted through the water fair list. In Community B, of the 32 households that we contacted with a phone call and email, 11 (34%) agreed to participate. Thirteen percent (13%) of the total Community B participants were from a household contacted through the water fair list.

Participant recruitment substantially benefitted from collaboration with the NMED Groundwater Water Quality Bureau and the NMDOH Private Wells Program. Getting a list from these programs’ water testing events offers an opportunity to contact individuals who are generally interested in their water quality and health. Not all households wanted to participate. Many of those who refused to participate were not concerned about potential exposures based on their previous water testing results, and/or expressed lack of desire to provide a urine sample for laboratory analysis. However, we had a strong response rate from participants on these lists in both communities. Furthermore, these households and individuals offer the potential to spread the word about the study, and perhaps contribute to recruiting others.

Coordinating with Tribes

Interagency Coordination Between the White Mesa Mountain Ute Tribe

The Utah biomonitoring team was contacted by several women from the White Mesa Ute Reservation indicating interest in participating in studies conducted by the program because of health and water quality concerns in their area. After doing some research, it was discovered that White Mesa is a tribal reservation, which is located adjacent to an active uranium mill and that there has been water quality concerns for quite some time in the community. The Utah biomonitoring team took appropriate actions to establish a working relationship with the tribe to include tribal members in the study.

Biomonitoring team members consulted with the state Indian Health Liaison and health consultant, who was able to guide the team on how to include the White Mesa Utes tribe members in the study. She provided direction on how to create a cohort, to contact tribal members and leaders and necessary steps to ensure the Utah IRB was sufficient for working with the tribe. The tribal liaison facilitated conversations with tribal leaders who gave the Utah biomonitoring team permission to take urine samples from interested participants to test for heavy metals and phthalate exposure. Certain regulations within the Natural Resources program within the Tribes governing body prohibit the removal of water from the land for testing. In order to comply with this regulation, the 4CSBC collaborated with the director of the Environmental Programs Department of the Ute Mountain Ute Tribe. The director provided the biomonitoring team with information about recently performed water tests to assist with exposure assessment in this region. He was also able to use his relationships within the community to inform tribal members about the sample collection. He secured the community center to use as a central place for collection, as well as placed recruitment flyers in the community prior to the collection date.

In addition to providing a venue, the director assisted the biomonitoring team during the sample collection event and went door to door reminding community members about the study. His efforts recruited a number of participants including families and children. The sample collection was successful in part, because of the outreach conducted by a trusted community member of the Ute Mountain Ute Tribe.

Coordination between the 4CSBC and the Ute Mountain Ute tribe offers benefit to both agencies, including members of the White Mesa Utes contributing to a more robust biomonitoring study. Coordination also provides availability of the biomonitoring program resources to Ute Mountain Ute Tribe members, which empowers community members with information about exposure to environmental concerns.

 

Safety

Dry Ice

Using Dry Ice in a Vehicle

Dry ice is used in outreach to bring collected urine down to long term storage temperature and, given the high temperatures typical in Arizona; we often travel with 2 coolers – 1 filled with specimens on dry ice and the second with extra dry ice. One lesson AZ Biomonitoring learned was that during overnight outreach (very common in AZ) when the coolers are kept in the locked car (rather than the hotel room) that the solid carbon dioxide will sublime to gaseous carbon dioxide and escape the cooler and fill the vehicle with bad air. We learned to start the day by opening the vehicle windows and turning off the air return so as to replace gaseous carbon dioxide with fresh air.

Using a Buddy System

Team Safety, Know the Area, Use a Buddy System, & Communications

The communities in the four corners region are typically small, isolated, and self-sustaining. Residents of these communities have had historical conflicts with certain actions of the federal government (for example BLM grazing restrictions). As a result, the level of trust for government activities varies in these kinds rural and frontier communities. Residents of these communities may not distinguish between levels of government (federal or state) or between agencies of government (law enforcement versus health). This fact raises the need to consider establishing several safety protocols before conducting biomonitoring activities in areas where there may be historic antagonism between local residents and “the government.”

It is important to know the area and sentiment before conducting biomonitoring activities in a community. One way to do this is to reach out to local community leaders to explain the biomonitoring project and its objectives. In this conversation, it is possible to get a sense of the community’s feelings towards the government and what could be trigger topics to avoid. We have found that using local community leaders to help introduce the survey team to the community helps alleviate many of the trust concerns.

It is important to follow the buddy system when visiting a participant on their own property. Working in pairs can mitigate dangerous situations (i.e., hazards on the property, dangerous animals, anger concerns, ill-intent, etc.) that, unfortunately, may occasionally arise when one deals with strangers – such as entering an individual’s home to perform the epidemiological interview or collect specimens/samples for analysis. And, since people sense danger differently, safe interview practice should also include an agreed upon word or phrase that can be used to let one’s partner know that it is time to leave without notifying the interviewee that a discomfort level has been reached. Safety first and it starts by working in pairs.

Every member of the survey team should have a cellphone on with them and should have the cellphone numbers of all other members of the team. Before visiting a participant, the team members should ensure that they have adequate cellular coverage to contact help if needed.

 

Reporting Results

Using the Web to Communicate

Utilizing a Study-Specific Website to Help Communicate with Biomonitoring Participants

Education and health communication is delivered in various formats throughout the biomonitoring process. For example, during enrollment and sample collection project staff explain the study to participants and answer any questions they may have. Later, results and recommendations are sent through the mail, and staff are available to answer questions over the phone and email. Between sample collection and results return there is limited communication with study participants. Participants may contact project staff with questions and updates, but with limited funding and staffing it is difficult for project staff to contact them individually.

To improve communication with participants the New Mexico Department of Health (NMDOH) utilized the NM Environmental Public Health Tracking (EPHT) portal to house a study-specific webpage. Participants were provided the web address URL at time of sign-up, and again at sample collection. This site was not accessible through ‘general browsing’ on the NM EPHT website. Individuals had to know the URL.

The site contained information about:

  • Why the project was occurring.
  • Participation requirements.
  • Participation instructions.
  • Sampling times/locations.
  • Timeline/updates for results.
  • Information about metals in drinking water, and treatment options.
  • Health information about excessive exposure to metals.
  • Links to the NM EPHT website (which offers links to the CDC EPHT website).
  • Contact information for project coordinators, and the NMDOH Environmental Health Epidemiology Bureau (EHEB) on-call service.

This model was first utilized during a biomonitoring study conducted in 2012. After sample collection, project staff tried to provide consistent updates on the website about sample analysis progress. Statistics are not available about website visits during this time period. Eventually, participants were mailed paper copies of their water and urine laboratory analyses, via certified mail. The packets included the NMDOH EHEB on-call number and the study-specific URL.

These results prompted most participants to further their knowledge by visiting the project-dedicated webpage that lead them to resources relevant to their interests and concerns. Web-user statistics show about 230 visits in a 2-month period with the majority seeking water treatment information. Also, 5 participants furthered their knowledge via the NMDOH EHEB on-call hotline to learn how to reduce their arsenic exposure inclusive of water treatment. Based on preliminary information, some participants appeared to change their behavior and/or sought to learn more about reducing exposures.

Had time/staffing permitted, we would have liked to conduct a comprehensive follow-up with participants to better understand if they found the webpage useful, recommendations for improvements, and the extent of health behavior change among all participants. This is a lesson learned, and will be implemented in future biomonitoring results communication work.

 

 

 

This page is in development. Come back often to see what we have added.

Last update: May 9, 2017