HIGHLIGHTS FROM STATE AND LOCAL PROGRAMS
New England Public Health Law Project — Partnering for Specialty Care at a Regional TB Referral UnitBackground
In many parts of the country, some patients might benefit from a specialized TB treatment unit. In such a unit, patients with complex disease or comorbidities can be treated, patient nonadherence issues can be addressed, and contagious patients can be isolated, involuntarily if necessary. Transferring care to a regional referral hospital through a legal agreement with the states is one way to provide comprehensive in-patient TB care where there are insufficient resources available at the local level.
Phase I: Defining the Problem
In 2007, the New England TB Consortium (NETBC) expressed the need for a specialized TB center to care for complicated and/or contagious patients who may require in-patient isolation. This concept evolved into a “National Call to Action on TB Isolation” adopted unanimously at the 2007 Northeast TB Conference which stated,
“This assembly requests that the National TB Controllers Association (NTCA)…bring together a working group of experts and stakeholders to establish the minimum legal standards and best practices for the use of enforcement powers including the isolation of infectious TB patients.”The Call coincided with a national initiative—to which the NETBC contributed through the NTCA—resulting in a TB handbook for public health and legal practitioners .
The conceptual framework for regionalization of TB care consisted of the following:
- Assure equity of care (e.g., using the least restrictive means to ensure TB cure),
- Define contagiousness (variable definitions used in each state),
- Enforce public health protective measures,
- Ensure patient rights and due process, and
- Create an Agreement allowing interstate transfer of patients to the Shattuck Hospital.
At the end of 2008, the NETBC decided to explore the legal basis for TB control in the region. TB program staff formed “The New England Public Health Law Project.” * This committee was championed by the staff and program managers from the Massachusetts, Connecticut, and Vermont TB Programs; the Harvard MPH/JD Program; the TB medical director at Shattuck Hospital; and DTBE.
The principal objectives of this project were to review TB laws in each state and to draft an Agreement to use the Shattuck Hospital as a regional comprehensive inpatient TB treatment facility. The Agreement would include provisions for due process, patient rights, and protection of the general public. During this phase, a law professor at the Western New England College School of Law, Katherine Van Tassel, researched and compiled the legal basis for TB control and isolation laws in the New England states and created a matrix modeled after one created by CDC’s Public Law Office.
Phase III: Reaching an Agreement between States and the Shattuck Hospital
At the end of 2009, a student from the Harvard MPH/JD program, Sarah Sorscher, undertook a review of case law concerning involuntary isolation and began drafting an Agreement. After input from the Massachusetts public health attorney, Steve Chilian, and from staff at the Shattuck Hospital, the document was circulated for comments from attorneys representing the other states. This process required coordination among the programs and the departmental attorneys, and was supported by Lisa Thombley, who until recently served as DTBE’s legal expert.
After review by the state attorneys, useful suggestions regarding services and fees were made by the contracts specialist and by the TB medical director, Lynn Sosa, in the Connecticut Department of Health. At the end of 2010, the Massachusetts TB controller, Sue Etkind, consulted with the state health commissioner, John Auerbach, which led to a call with the New England public health commissioners. On that call, it was proposed that the respective state attorneys be convened to explore a consensus position.
In December 2010, the first call with attorneys identified new concerns. A major point of discussion involved jurisdictional issues and whether the court in the patient’s home state would be willing to issue a final order suspending its jurisdiction while the patient was at the Shattuck Hospital or would require its own continuing judicial review. Similar questions arose regarding the jurisdiction of officials involved in interstate transport. A second phone call with the state attorneys was held in February 2011. On that call it was decided to create two separate Agreements, one for voluntary admissions and one for involuntary admissions.
The Agreements are now with the individual states where review may be required by the attorney general’s office as well as the state health commissioner. In at least one state that does not have statutory power to enter into contracts with another state, legislative action is necessary.
Impact and Lessons Learned
Partner building: One key to success was the partnership formed between the region’s TB programs and other entities. The TB programs were able to provide a clear statement of purpose that allowed for the state health commissioners to support the vision in practical ways. Likewise, building consensus among stakeholders made it easier to engage partners such as the Harvard MPH/JD program.
Consensus building: Stakeholders include several public health departments (i.e., Commissioners, TB programs, department attorneys, and contracts officials), the hospital, patients, and the state legislatures. Consensus was reached by finding common ground among the TB programs, seeking out other stakeholders, engaging partners in a dialogue, and incorporating differing perspectives.
The long haul: Retrospectively, we could have condensed the process and focused on an Agreement with the Shattuck facility thereby completing that goal in less time. However, we would have lost the review of present laws and the deeper understanding of the strengths and gaps found in the existing legal basis for TB control.
—Submitted by Sue Etkind, Director, Massachusetts Division of TB Prevention and Control;* New England Public Health Law Project: Connecticut (Heidi Jenkins, Lynn Sosa), Maine (Kathy Gensheimer, Adriene Rister), Massachusetts (Sue Etkind, Linda Singleton, Steve Chilian), New Hampshire (Jill Fournier), Rhode Island (Michael Gomsciminski), Vermont (Susan Schoenfeld), Shattuck Hospital (Maria Tricarico, Marie Turner), Harvard MPH/JD Program (Katharine Van Tassel, Sarah Sorscher), Public Health Law Network (Dan Stier), and DTBE (Lisa Thombley, Mark Lobato)
Heidi Jenkins, Connecticut TB Control Program Manager;
Susan Schoenfeld, Vermont TB Control Program Manager;
Mark Lobato, New England TB Consultant, DTBE
Heidi Jenkins, Connecticut TB Control Program Manager;
Susan Schoenfeld, Vermont TB Control Program Manager;
Mark Lobato, New England TB Consultant, DTBE
Since March 2009, one of Indiana’s largest counties has been working diligently to control a TB outbreak among the homeless population; this report provides an update as of October 2011. There have been 23 cases (22 males and 1 female) associated with this TB outbreak. Among the 23 cases, 22 were part of the same genotype cluster that is unique to the state of Indiana (except for one case that was counted by another state), while 1 clinical case was epidemiologically linked to the cluster. One of the cases was diagnosed with TB at death; the remaining 22 (96%) started treatment. Eighteen (82%) of the 22 cases who started treatment have successfully completed treatment; two died shortly after TB diagnosis and treatment initiation: two currently remain on treatment (completion completion status of out-of-state case patient is unknown). All of the cases who successfully completed treatment are known to have received directly observed therapy (DOT) for the duration of their treatment.
The county health department’s TB program had to overcome many challenges in order to gain control of the outbreak. Within 1 month of the homeless outbreak, the county realized that the associated cases were not being cooperative in providing real names of close contacts. Many of the cases were only familiar with their close contacts by nicknames or on a first-name basis, which made it difficult to find them. Furthermore, this population is transient, so the community health workers would be unable to locate the few contacts who were identified. The county health department also recognized that some of the contacts with latent TB infection (LTBI) and cases were not motivated to complete treatment despite monthly monetary incentives. Many of the cases have other social risk factors (i.e., excessive alcohol and drug use) and medical conditions (such as HIV, diabetes mellitus, and others) that interfered with their adherence to treatment. With limited resources, the local health department realized the need to collaborate with other local agencies in order to overcome this population’s barriers to treatment adherence and to gain control of the outbreak.
Community Collaboration Activities
Outbreak Response Meetings – In October 2009, the county health department began having biweekly outbreak response team meetings to discuss the status of each TB case as well as identify solutions to the challenges in controlling this outbreak. After the county health department had better control of the outbreak, the outbreak response team changed to meeting on a monthly basis. The participants included the County TB Program Coordinator, the County TB Medical Director, the County Epidemiologists, the County Lab Coordinator, the Outbreak Nurse Case Manager, the County Jail Nurse, the Outbreak Community Health Worker, the directors of the three homeless shelters that had been identified as sites of transmission, the County Social Worker, a non-profit homeless outreach organization, and the Indiana State TB Control Program (CDC Public Health Advisor). During the meetings, the status of each TB case was discussed and solutions were proposed for overcoming the challenges of the outbreak.
Cluster-Buster Meetings – The county health department has four district clinics, thus most of the TB cases were managed by different public health nurses. With the patients not identifying their close contacts, the county health department had to strongly rely on common settings to be able to find and evaluate contacts. With the public health nurses being in various clinics located throughout the county, another challenge was gathering and sharing the necessary information regarding the common locations of the case patients. The county began having biweekly cluster-buster meetings to allow the public health nurses and community health workers to gather and discuss common factors among the frequented locations. Based on new findings in each meeting, the public health nurses and community health workers were given more specific questions to ask their patients before the next meeting. As a result, several new sites of possible transmission were identified and visited for targeted testing and for locating contacts who were lost to follow-up.
Letters of Understanding – In order to overcome the challenge of identifying contacts to infectious cases, the county health department worked with their legal advisors and community agencies to develop letters of understanding. These documents allowed the county health departments to share names of missing or lost infected contacts with agencies that agreed to adhere to confidentiality laws. The county health department was able to establish letters of understanding with three prominent men’s homeless shelters, a well known non-profit agency serving the homeless, social service agencies, community health centers, and a hospital that the homeless population frequented. The health department was able to collaborate with a prominent hospital and all of its health affiliated clinics in order to routinely post a list of lost/missing infected contacts, using their electronic medical system. Therefore, when someone from the list presented to the emergency room or any of the health affiliated clinics, the medical system would alert the hospital staff that the person needed to be evaluated for TB and the county health department needed to be notified immediately.
Large Targeted Testing Events – In summer 2009, the county health department conducted targeted TB testing in three prominent local homeless shelters for men. The health department chose to administer interferon gamma release assays (IGRAs) to avoid the possibility of losing individuals before they returned to have their TB skin test read. However, the health department still faced many challenges with finding those with positive IGRA results in order for them to get chest x-rays and medical examinations and to start treatment.
In early spring 2010, the county health department participated in an annual event popular with the homeless population that provides a series of health, social, and legal services to homeless individuals. During this event, the health department offered free IGRA testing and HIV testing to homeless individuals. In order to avoid losing track of individuals with positive IGRA results, the health department provided the individuals who received an IGRA test with a card printed with instructions to return on the following Saturday to a specific location. The chosen location was popular with the homeless population on Saturdays because other agencies routinely visited there and provided them with free food and services on that day. The individuals who returned for their results received an incentive, and transportation was immediately provided for those with positive results so that they could receive chest x-rays, get medically examined, and start treatment. Those who went to get medically examined also received another incentive. During their medical examination, it was established where each individual would meet the community health worker for DOT. The county health department provided the same testing services at the same event that was held in spring 2011.
Weekly Testing in Homeless Shelters – In order to control the TB outbreak and prevent more cases in the future, in September 2010 the county health department began working with one of the prominent local homeless shelters to provide IGRA testing, twice a week, to new guests. As a result of this effort, the county local health department found the clinical case associated with the cluster. The county health department also provided funding to one of the prominent homeless day shelters for a nurse to provide directly observed preventive therapy (DOPT) to infected contacts and TB testing of new shelter guests.
Targeted Testing on the Streets – In collaboration with a local non-profit homeless outreach organization, the county health also performed targeted testing on the streets in order to screen some of the homeless individuals who did not frequent the local homeless shelters.
Environmental Control Measures – With some CDC funding and collaboration with the Indiana State Department of Health TB/Refugee Health Division, the county health department worked with the largest local homeless shelter to implement and maintain ventilation control measures (e.g., UV lighting, HEPA filters) before the influx of homeless individuals in the winter months of early 2011.
Results of Testing Activities – Since beginning targeted testing in summer 2009, the county health department has done 1,421 TB tests (some individuals may have been tested more than once). There have been 185 (13%) individuals with positive TB test results (+QFN, TSPOT.TB, or TST); 158 (85%) of the 185 individuals with positive TB tests were fully evaluated with chest x-rays; and 132 (71%) individuals started treatment for LTBI. Of those who started LTBI treatment, 84 (64%) have completed and 33 (25%) currently remain on LTBI treatment.
Lessons Learned – It would have been advantageous for the county health department to have had an established TB outbreak response plan. During the outbreak, the county’s TB coordinator changed positions, which left the management of the outbreak to staff members who had other job priorities and staff who normally did not perform TB control duties. A written plan would have assisted the staff in managing the outbreak more effectively while in its early stages. Secondly, the county health department realized the importance of constant community input and collaboration. The local community homeless shelters and agencies offered invaluable resources and knowledge regarding the most effective means of finding, screening, and treating the homeless population. Lastly, the county health department recognized the need to have a TB nurse and community health worker designated to routinely work with the homeless shelters in order to maintain control of this outbreak and prevent any future outbreaks among this vulnerable population.
Future Plans – The health department continues to provide testing services in the prominent local homeless shelters. The health department is also working with different shelters to develop written TB screening policies that incorporate cough logs, routine TB screenings for all new shelter guests, and routine education for staff and guests. The TB homeless outbreak response team continues to meet on a monthly basis and has begun the planning for future shelter health fairs that will offer services beyond TB testing and HIV testing (e.g., flu vaccines).
—Reported by Shanica Alexander
CDC/DTBE PHA, Washington, DC
CDC/DTBE PHA, Washington, DC
New Jersey (NJ) ranked fifth highest in the nation in percentage of foreign-born residents during 1990, 2000, 2007, 2008, and 2009, according to the American Community Survey, an ongoing statistical survey by the U.S. Census Bureau. During the last 10 years, the NJ TB program has consistently reported a higher morbidity among foreign-born residents than among U.S.-born residents. In 2009, 77% of its active TB cases were among foreign-born persons, many of whom originally came from countries with a high incidence of TB.
This report presents an analysis of data on immigrants and refugees referred to the TB Program for medical follow-up through the Electronic Disease Notification (EDN) system by the CDC Division of Global Migration and Quarantine (DGMQ) in 2008 and 2009.
To be admitted to the United States, immigrants and refugees are required to be screened for TB and other diseases that place the public health at risk. Applicants for U.S. immigration are screened in their country of origin by panel physicians. Refugees, persons who have crossed an international border and have a well-founded fear of persecution, are also screened overseas before being admitted to the United States.
Screening for tuberculosis according to the 2007 Tuberculosis Technical Instructions, includes sputum smears and cultures for tuberculosis suspects. It also includes testing for tuberculosis infection (via tuberculin skin testing (TST) or interferon gamma release assay [IGRA]) for applicants 2–14 years of age being examined in a country in which the World Health Organization estimated tuberculosis incidence rate is ≥20 per 100,000. Upon diagnosing a TB condition and assigning a TB classification, the screening physician is required to complete four Department of State (DOS) forms, which applicants must have with them while traveling. At the port of entry, these forms are collected by the Customs and Border Protection (CBP) of the Department of Homeland Security, forwarded to Quarantine Stations, and then sent to the Electronic Disease Notification System (EDN) data entry center in Atlanta, Georgia.
The current TB classifications under the 2007 TB Technical Instructions (TB TIs) assigned to immigrants or refugees identified overseas with a TB condition are as follows:
A – Infectious TB disease: sputum smears and/or cultures are positive; requires waiver to enter the U.S.
B1 – Noninfectious TB disease: includes active, noninfectious pulmonary TB (i.e., abnormal X-ray, but sputum smears and/or cultures negative); inactive pulmonary TB; extrapulmonary TB; previously treated TB; old healed TB.
B2 – Latent TB infection (LTBI), needing evaluation
B3 – Recent contact to a known TB case
The EDN system contains data on all refugees admitted to the United States and immigrants admitted with certain medical conditions of public health importance. CDC personnel scan the forms into EDN. The system generates automatic electronic notifications to state health departments and provides access to scanned overseas medical records, examination forms, and addresses in the United States. In NJ, the TB program immediately updates the MS Excel spreadsheet and prepares a formal TB investigation form with all the documentation received via EDN. It is mailed overnight to the chest clinic that will be providing services to the immigrant or refugee.
Persons with an overseas chest radiograph consistent with TB are required to have a medical evaluation in NJ within 30 days after receiving a referral from the TB chest clinic. The medical evaluation, including disposition, diagnosis, and treatment recommendations, should be completed within 90 days. All immigrants and refugees with TB conditions referred by EDN are located, evaluated, and treated free of charge.
After follow-up efforts at the local chest clinic have been completed, the TB investigation report follow-up form is updated by the nurse case manager and faxed to the TB Program. The MS Excel spreadsheet is updated and the TB follow-up worksheet is sent electronically to EDN.
Summary of data for persons with B1 TB classifications during 2009
- Of 382 B1 notifications received in NJ, 286 or 75% were fully evaluated and 96 or 25% were lost, relocated, or refused.
- Of the 286 persons fully evaluated, 1 was diagnosed with TB disease, 25 had inactive TB, and 105 had LTBI, for a total of 131 or 46% with a TB condition.
- Of the 131 with a diagnosed TB condition, 111 or 85% started treatment and 49 or 46% completed treatment; the patient with TB disease was among those completing treatment.
- Of 413 B2 notifications sent to NJ, 302 or 73% were fully evaluated and 111 or 27% were lost, relocated, refused, or died.
- Of the 302 fully evaluated, 2 were diagnosed with TB disease, 12 had inactive TB and 150 had LTBI, for a total of 164 (54%) with a TB condition.
- Of the 164 with a diagnosed TB condition, 146 or 89% started treatment and 65 or 44% completed treatment. Of the 2 patients diagnosed with TB disease, 1 completed treatment. The other returned to Bangladesh, taking with him a 1-month supply of medication. The patient also took a copy of his medical records to give his doctor. In addition, the NJ TB program sent an official international form notifying the physician of the diagnosis and treatment of the patient.
In 2009, New Jersey had 795 recent immigrants and refugees with B classifications referred to the state by DGMQ for medical follow-up, compared to 420 referrals in 2008, an increase of 89%. Despite the significantly increased burden of referrals, the percentage of those medically evaluated dropped by only 2%, from 76% in 2008 to 74% in 2009.
For these labor intensive and time consuming activities, the percentage yield of persons evaluated who were found to have a TB condition dropped from 57% (181/319) in 2008 to 50% (296/588) in 2009. New Jersey did see a reduction in importation of active disease: in 2008, the TB case yield was 5 cases; in 2009, the yield of these activities was 3 cases.
In 2009, New Jersey experienced an increase in the number of referrals received in 14 of its 21 counties. Hudson County was the most affected with a 215% increase in referrals, from 40 in 2008 to 126 in 2009. The other 7 counties with more than 50 referrals in 2009 were: Middlesex (116), Camden (74), Passaic (66), Essex (65), Atlantic (63), Bergen (61), and Union (58).
Data regarding treatment initiation or completion was not collected for the 2008 cohort, so a comparison to performance with the 2009 cohort could not be made.
It was anticipated that the revised TB TIs would increase the number of referrals for medical follow-up, due to the introduction of screening for LTBI overseas among children in high incidence countries. In fact, such a foreign-based targeted testing program was welcomed by NJ. What was not anticipated was that 46% of Class B2 referrals with a reported positive Mantoux tuberculin skin test (TST) overseas would be TST negative in the United States. If the TST was not required to be repeated for persons with a B2 classification as a standard protocol during the evaluation process in 2009, regardless of existing documentation, many of these patients would have been misdiagnosed with LTBI and prescribed unnecessary treatment. The quality of the overseas screening must be improved so that the revised TB TIs can realize the intended benefit without unnecessarily taxing limited public health resources in the United States. Such improvement is likely since 2009 was the first year screening for LTBI was done as part of the overseas assessment. In addition, 27% of NJ’s Class B2 referrals were from the Dominican Republic and issues had been reported by DGMQ regarding the PPD being used to TST in that country in 2009.
NJ anticipates the percentage of referrals with a B2 classification found to have no TB condition will increase even more significantly in the future due to the implementation of QuantiFERON® TB–Gold (QFT) testing in 2010 in New Jersey. This outcome is highly likely so long as the TST is the predominate test used by panel physicians to screen for LTBI overseas.
The NJ public health community working in TB clinics involved in activities surrounding Class B referrals are commended for stable performance in the proportion of referrals for which an evaluation was completed in 2009 compared to 2008 (76% and 74%, respectively), despite a significant increase in the total number of referrals (89%). This objective was achieved through increased productivity of existing staff, not by adding staff. No detrimental effects of this increased workload were observed in performance towards national and state objectives, despite the fact that the five counties in NJ with the highest number of Class B referrals in 2009 were also the counties reporting the highest TB morbidity that year. The introduction of QFT in 2010 and the resulting decline in the number of contacts and Class B referrals requiring treatment will allow additional productivity gains in the future.
Of the 296 referrals evaluated as having TB conditions in 2009, a total of 257 persons or 87% started treatment, but a 44% completion rate must be improved to have a significant long-term impact on TB incidence in NJ. Improving performance, however, will be difficult in this highly mobile population.
—Reported by Mildred Perez
PHA, New Jersey TB Control Program
PHA, New Jersey TB Control Program