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APPENDIX C

Site Visit Summaries

ATLANTA SITE VISIT
JULY 19–20, 1999

Committee members Donald Hopkins and Audrey Gotsch, accompanied by Larry Geiter and Donna Almario, visited with CDC staff in Atlanta on July 19, 1999. The focus of the visit was the activities the Field Services Branch of the Division of Tuberculosis Elimination. There were additional presentations on the Public Health Prevention Service and TB laboratory activities.

Field Services Branch

The Field Services Branch provides medical and programmatic consultation to State and local health departments in tuberculosis control activities and is a focal point linking the CDC with TB controllers. One current priority of the branch is enhancing program evaluation activities. Medical officers in the branch have been teamed with the public health advisor consultants to work with the State and local programs on evaluation activities. Evaluation indexes have been revised and new report forms (replacing the “Rainbow Reports”) have been submitted to OMB for clearance. The purpose of these changes is to increase accountability in the use of cooperative agreement funds (see below). Don Hopkins commented on the evaluation indexes advising that a few of these, preferably only two or even one, if possible, should be chosen as milestones toward elimination.

The cooperative agreements are up for renewal this year and are



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Page 182 APPENDIX C Site Visit Summaries ATLANTA SITE VISIT JULY 19–20, 1999 Committee members Donald Hopkins and Audrey Gotsch, accompanied by Larry Geiter and Donna Almario, visited with CDC staff in Atlanta on July 19, 1999. The focus of the visit was the activities the Field Services Branch of the Division of Tuberculosis Elimination. There were additional presentations on the Public Health Prevention Service and TB laboratory activities. Field Services Branch The Field Services Branch provides medical and programmatic consultation to State and local health departments in tuberculosis control activities and is a focal point linking the CDC with TB controllers. One current priority of the branch is enhancing program evaluation activities. Medical officers in the branch have been teamed with the public health advisor consultants to work with the State and local programs on evaluation activities. Evaluation indexes have been revised and new report forms (replacing the “Rainbow Reports”) have been submitted to OMB for clearance. The purpose of these changes is to increase accountability in the use of cooperative agreement funds (see below). Don Hopkins commented on the evaluation indexes advising that a few of these, preferably only two or even one, if possible, should be chosen as milestones toward elimination. The cooperative agreements are up for renewal this year and are

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Page 183 based on level funding. This is actually an effective reduction in funding, due to inflation, and a real reduction in funding, since many of the program areas have relied on carry-over funds from previous years to maintain their level of funding. The cooperative agreement funding has been divided into funding for core activities (surveillance, laboratory, completion of therapy for active cases, and contact investigation) and funding for elimination activities (e.g., targeted tuberculin testing and treatment of latent infection). Five percent of the funding is reserved for the elimination activities and is dependent on the performance in the core activities. The branch has 48 field staff positions assigned to State and local tuberculosis programs. Currently there are 33 public health advisors and 5 medical officers assigned and 12 vacancies. The medical officer assignments are considered a priority to provide additional public health physicians in the future with training and experience in tuberculosis. The large number of vacancies is a result of a CDC decision in 1994 to suspend hiring of new public health advisors through the STD and TB programs. The tuberculosis division has received approval to hire entry level public health advisors and plans to bring on 8–10 new hires. Addressing elimination issues, the branch staff commented that level funding will clearly be inadequate. Regionalization of services and expertise will also be in important issue. Public Health Prevention Service The decision to suspend hiring in the public health advisor series was followed by the creation of a training program called the Public Health Prevention Service. This is three-year program consisting of one year of three-month rotations through different programs in Atlanta and two years of working in a State and local program with a CDC and local mentor advising them. Candidates for the program all have Master's degrees in a field related to public health, the third class of 25 has recently begun training, and the first class will graduate next year. This program will provide a program designed in consultation with the State and local programs for highly trained staff to assist with program planning, implementation, and evaluation. Laboratory Laboratory issues were addressed by staff from the Division of Laboratory Services in PHPPO and from the Tuberculosis and Mycobacterial Laboratory Branch in the Division of HIV/AIDS, STD and Tuberculosis Laboratories. The Division of Laboratory Services is involved in a variety of training and laboratory assessment activities. A major issue is main

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Page 184 taining training levels and competence as tuberculosis laboratory services are more often provided in the private sector. One challenge for working with the private laboratories has been developing reimbursement models so that rapid smear results can be provided on site before referring the specimen to a full service laboratory. The division is also providing assistance internationally through the development of training materials and providing consultation to selected national laboratories (Mexico) through WHO and PAHO. The laboratory provides reference laboratory services and a national genotyping surveillance network through seven laboratories. The surveillance project currently covers about 15% of isolates in 15 states. The laboratory also provides consultation in the evaluation of new laboratory technology for operational use. The site visit on July 20 continued with a review of the tuberculosis program in Atlanta and the State of Georgia by Don Hopkins and the IOM staff. Fulton County Health Department of Health and Wellness serves the largest county in the state of Georgia, covering a 535 contiguous square mile area and encompassing approximately 88 percent of the city of Atlanta. 187 cases were reported 1998. The vast majority were U.S.-born African-Americans with a smaller proportion of foreign-born cases than the average of the United States. Public services are provided through a central tuberculosis clinic staffed by clinic and outreach staff. Major challenges to the program include a reorganization of staffing and cost-recovery efforts. The county HIV/AIDS, STD, and TB programs are being merged in an attempt to reduce costs and enhance service delivery. The merger has just begun and management staff expressed optimism that outreach workers would be able to provide multiple services to the patients and families they work with. Outreach staff expressed some concern about cross training. No one is denied services due to an inability to pay but, after receiving services, everyone must complete an interview about their ability to pay and receive a bill. Third-parties are billed when there is insurance. Outreach and clinic staff expressed concern that, even though patients will not be required to pay, charging for services and the eligibility interview will serve as a barrier for the patients. Grady Hospital Grady Hospital is a large public hospital located across the street from the health department. The tuberculosis services are provided by staff from Emory University. During our meeting it was pointed out that about 25% of all cases in the State are first encountered and treated at Grady Hospital. While Grady Hospital receives about $350,000 annually in combined state and federal funding for tuberculosis activities, staff

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Page 185 expressed concern that the public hospital, locally and nationally, is rarely considered part of the tuberculosis program or considered for tuberculosis funding. Nosocomial transmission was identified as a major problem at Grady Hospital in the past and a state-of-the-art isolation facility was constructed on one floor. One of the advantages of having the single isolation unit was that staff were better able to keep patients in their rooms and daily sputum collection could be more easily managed. Georgia State Program Georgia has the second highest rate among states in the southeast and 631 cases were reported in 1998, a decline from a peak of 909 cases in 1991. Two special issues discussed were management of contact and outbreak investigations and obtaining Medicaid reimbursement for tuberculosis. A report was recently published on an outbreak in Georgia associated with a floating card game. The cases occurred over a considerable period of time before it was recognized as a cluster since contact interviews were focused on households. It was only after a significant increase in cases in the area resulted in an outbreak investigation that the association was uncovered. The State staff are considering ways to train local staff who only occasionally deal with tuberculosis on ways to conduct more complete contact interviews and investigations. Several attempts to obtain Medicaid reimbursement for tuberculosis have been made and the State Medicaid program has declined the request each time. The apparent reasons are a concern that once Medicaid eligibility is improved that the number of cases will suddenly increase dramatically (not totally incorrect if treatment of latent infection is included) and that the Medicaid budget will increase dramatically, a politically sensitive issue. WASHINGTON, D.C., SITE VISIT SEPTEMBER 29, 1999 On September 29, 1999, Philip Hopewell, Patrick Chaulk, and Fran DuMelle represented the IOM's Committee on Tuberculosis Elimination, and IOM staffer, Donna Almario, visited D.C.'s Tuberculosis Clinic located on the grounds of D.C. General Hospital. The site visit provided a closer look at the effects of the lack of political will. D.C. had 107 tuberculosis cases in 1998, and it is projected that D.C. will have only 70-75 cases in 1999, approximately a 30% decrease. Officials were speculating if this decrease is true.

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Page 186 Funding There has been some concern raised in the proportional decrease in funding as cases decrease. As cases decrease, there will be less DOT and fewer case investigations; however, the program cannot afford to lose 25% of their funding because of a decrease in cases. The local government funds about 50% of the TB programs whereas the federal government provides the other half (covering staff, x-rays, and reagents). A majority of the federal funding comes from CDC's cooperative agreement, and other support comes from Public Health Block Grants. Federal funds are limited, though, in that they do not cover funds for building maintenance or medications. The Effects of an Organization in Disarray Several problems plague the D.C.'s TB control program: program disorganization, dilapidated facilities, outdated computer programs, and an insufficient number of staff. Most of these problems reflect the disarray and the lack of political will in the D.C. government, including frequent turnover of top officials, political officials unfamiliar with tuberculosis, restructuring within the Department of Health, and budget difficulties. In light of these problems, steps have been taken to reorganize the tuberculosis program. Margaret Tipple, a CDC advisor, joined the program six months ago and has taken the initiative to improve the program by assuming the director's role. Unlike most CDC advisors who assist local TB programs, Tipple has taken the lead role in the TB program. Although a benefit to the D.C. program on a short-term bias, her role may not be beneficial in the long term since there may be an overreliance on the local program on CDC. Laboratory The impact of the political structure in D.C. has contributed to an incomplete public health laboratory renovation. In 1997, the Centers for Disease Control and Prevention granted $400,000 to renovate D.C.'s public health laboratory. After 3 years the laboratory is now 90% complete, with a new incubator and refrigerator, stocked with now expired reagents, and designed as a level 3 laboratory. However, due to the lack of trained personnel, the laboratory will remain inoperable for the next few months. Participants at the site visit commented that it would be beneficial to have a full service TB laboratory in the District, especially given that ten hospitals and several medical schools are in the area. Tuberculosis specimens were previously sent to a Virginia laboratory, but D.C. preferred to

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Page 187 retain the specimens. Thereafter, the TB clinic arranged an informal agreement with D.C. General to test specimens, including AFB smears, cultures, and rapid testing. Drug sensitivity tests are sent to an outside laboratory. Housing Two apartment buildings with four units each were available for MDR-TB cases and potentially noncompliant patients. The landlord breached the contract, and the tuberculosis program does not have housing for these individuals. The program is in the process of looking for replacement housing. Outreach Workers There are seven outreach workers and one manager who oversee the DOT program at the TB clinic. On average, each outreach worker supervises eight patients and visits each patient three times a week. In addition to administering DOT, each outreach worker conducts case investigations, screening, educational activities, TB skin testing, contact investigations, and brings positive skin tester in for X-rays. The staff is overworked and had problems reaching these patients until six months ago when the program acquired a car. Since many of these cases deal with multi socioeconomic issues, including being in and out of correctional facilities, comorbidity of STDs and HIV, using drugs, and/or being homeless, having a social worker on staff would be beneficial to caring for the patients. Foreign Born In 1998, there were 107 reported active cases of tuberculosis. Of these cases, 33% were in the foreign born. Country of origin for these cases include the Philippines, Mexico, Haiti, India, and Vietnam. The length of stay in the U.S. was the following: 24% were here 1 to 9 years, 6% were here less than one year, and for 67% of them, the length of stay was unknown. In addition, 12% were homeless and 27% were HIV-positive. Given the increase in the foreign born, it has been difficult treating them given the cultural and language barriers. There is no interpreter on staff to assist providers in caring for these individuals. Registry The registry for tuberculosis cases has several problems: no computer specialist, shortness of staff, numerous vacancies, and dated operating

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Page 188 systems and hardware programs. To date, the programs were not Y2K compliant. Partnership with TB Task Force In response to a 1994 CDC review, the D.C. Medical Society, along with the D.C. American Lung Association established the TB Task Force to oversee the D.C. tuberculosis program. The task force meets yearly to discuss accomplishments and goals and have taken issues, such as the laboratory, under their responsibility. However, even with this organization, it has been difficult to build political will. For example, a half-day conference was recently organized to discuss goals for D.C.'s TB control program. Goals created during the meeting were produced only in an internal document and were not disseminated outside the Task Force. Michael Richardson, head of the TB Task Force, started to establish a good control program; there should be ongoing communication between the CDC and local officials to ensure the longevity of such a program. D.C. needs continuity of leadership to promote the message about TB. Conclusions D.C. has problems typical of many urban centers. But because of the political disorganization of the city government, this has augmented the quality of care to tuberculosis patients in the city. These is seen in the examples cited above: the lack of staff, an incomplete public health laboratory, lack of housing for highly infectious individuals, and difficulties in communicating to a growing TB population in the foreign-born. MASSACHUSETTS SITE VISIT AUGUST 16, 1999 On August 16, 1999, Ronald Bayer, Sue Etkind, and Morton Swartz from the IOM Committee, along with Lawrence Geiter and Donna Almario, IOM staff, visited Boston, Massachusetts to learn from the TB control programs on both the city and state level. Boston Tuberculosis Control Program John Bernardo, Denise O'Connor, and Claire Murphy presented an overview of Boston's Tuberculosis Control Program. The program is located at the Boston Medical Center and is the largest tuberculosis clinic in the state with more than 10,000 visits per year. It provides resources for

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Page 189 diagnosis and management of tuberculosis and offers free services including free medication. In 1998 there were 89 tuberculosis cases in the Boston area. Seventy-two percent of these cases were in the foreign born, representing 52 countries. In terms of preventive therapy, language and cultural issues are seen as a barrier to administering therapy. Because of these and other issues, all tuberculosis cases in Boston are cared for under a nursing case management system. Nursing Case Management System In this case management model, public health nurses are utilized to assist in managing patients with various cultural and ethnic backgrounds. These issues can been seen as barriers, but the nurses work with the patients to coordinate administration of TB therapy. The main mission of the management is to promote the coordination of necessary medical, nursing, outreach, and social services to assure that all suspected and confirmed cases of tuberculosis are appropriately and effectively treated. The model attempts to maintain trust between the patient and the provider, acknowledges patients' rights in their own treatment, and assure treatment completion. The public health nurses have the following responsibilities as case manager: Clinician. The public health nurse collaborates with the primary physician, follows patients from diagnosis to discharge, continually assesses the clinical response and treatment adherence, conducts contact investigation, and medical evaluation of contacts. Coordinator of Care. Develops and adjusts individualized management plan, Facilitates necessary collaborations to implement treatment, coordinates discharge planning from inpatient facilities, and enforces involuntary hospitalization (last resort). Educator. Assesses education needs, designs education plan sensitive to health beliefs, provides TB information to families, colleagues, and community. Patient Advocate. Recognizes societal factors that impact on treatment completion, becomes a liaison between patient and social services, develops responses to address non-clinical issues, and helps patient accommodate TB treatment as a personal priority. From 1993 to 1997, there were 469 tuberculosis cases in Boston who were alive at diagnosis and whose data were complete. A total of 401 completed therapy. The other 67 had either moved, were lost, refused/

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Page 190 other, or died. About 266 (67%) had self-administered therapy, 120 (25%) had total DOT, and 83 (18%) had either self-administered or DOT. In addition the TB clinic coordinates with other satellite specialty clinics including East Boston's Neighborhood Health Center, St. Elizabeth's Hospital in Brighton, Suffolk County House of Correction, Pine Street Inn (homeless shelter), and Boston Methadone Treatment Clinics. The committee and staff visited Pine Street Inn. In 1996, there was an outbreak of tuberculosis in the homeless shelter. Since then, skin tests have been done biannually, there is a cough log, and HEPA filters have been installed. Transmission since than has decreased. Community Based Approach Towards Prevention Along with the case management model, the tuberculosis program utilizes a community-based approach toward TB prevention. This includes collaboration with neighborhood health centers and education of providers at neighborhood health centers. Unlike community based organizations which are federally funded, neighborhood health centers are non-profit and privately funded, with some funding from the federal government. Numbers show completion rates for preventive therapy differ between Boston Medical Center's TB Clinic and neighborhood health clinics. Neighborhood clinics had a completion rate of 80% for preventive therapy where Boston Medical Center had a completion rate of 30%. Massachusetts Department of Health, Division of TB Control State and local resource allocations to the cities and towns in Massachusetts vary depending on the tuberculosis morbidity rates. Instead of a county health department, each of the 351 cities and towns has their own autonomous health department. The state TB Division and the locality share responsibility for tuberculosis control. Smaller towns or areas may have variable resources to control tuberculosis. For example, Cambridge has several public health nurses, whereas in nearby Somerville, there is only one part-time public health nurse. A county health department system would help equalize resource distribution. The Commonwealth of Massachusetts and the Centers for Disease Control and Prevention (through the Cooperative Agreement) provide a similar proportion of funds for tuberculosis control. Funds from the Cooperative Agreement cover many employees, such as central office staff, a regional nurse and outreach capacity. State funds cover the balance of the staffing, the provision of free TB medications, as well as data collection and education and training. In addition, the state provides funding for TB

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Page 191 diagnostic and therapeutic services at no charge to all Massachusetts residents through 26 clinics statewide. Participants in the site visit commented that the future of TB service delivery may entail integrating part or all of these services with managed care organizations. The State Mycobacteriology Laboratory conducts drug susceptibility testing on all submitted specimens free of charge. A computer system links the TB case managers with the TB Laboratory database, centrally and regionally, allowing immediate access to the most recent patient lab results. About 70% of all specimens are sent to the State Lab as either primary or reference cultures. The rest of the specimens are from managed care organizations who contract out to private laboratories within and outside of the state. This is a potential problem—specifically for quality control and cross-contamination issues. Lemuel Shattuck Hospital, Tuberculosis Treatment Unit The site visit participants also visited the Lemuel Shattuck Hospital which has a treatment unit used for both voluntary and involuntary hospitalization. The hospital is funded by the Department of Public Health and has a collaborative relationship with the TB Division. SAN DIEGO SITE VISIT AUGUST 2–3, 1999 Peter Small and Lester Wright, members of the committee, and Larry Geiter and Donna Almario, IOM staff, visited with staff of the San Diego County Tuberculosis Program in California on August 2–3, 1999 and also visited tuberculosis control facilities in Tijuana, Mexico on August 3. During the course of the visit the committee members and staff met with Dr. Kathleen Moser, Director of the San Diego County Tuberculosis Program, Dr. Sarah Royce, Director of the California State Tuberculosis Control Program, a public health nurse with the tuberculosis program in San Diego, a disease investigator/outreach worker, director of the San Diego County Public Health laboratory, a pediatrician at the University of California, San Diego, who also works with the county tuberculosis program, staff of the San Diego County ALA and the advisory committee on the elimination of tuberculosis, staff of the Cure TB bi-national tuberculosis program, and staff of the Central Health Center in Tijuana, Baja, Mexico. San Diego is the second largest county in California and the city is the sixth largest metropolitan area in the United States. Although cases occur throughout this large city, the highest case rates are found in the downtown area and close to the Mexican border. Issues surrounding TB control

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Page 192 in San Diego County include geographic distances, cultural and language barriers, and proximity to Mexico. Program Structure The San Diego County Tuberculosis Control Program is part of the San Diego Health and Human Services Agency. The program is categorical within the agency with funding from the county and categorical funding from the state. Services are rendered through a network of primary health care centers throughout the county. Health centers are located in six regions, and each region has public health nurses who provide field management services for patients in their region. Once an individual is identified as a TB suspect, the PHN case manager provides oversight until the individual until the person completes therapy, dies, etc. A disease investigator assists the PHN case managers with the most non-adherent patients. Together, they are very successful in assisting patients in completing their therapy. About 70% are on DOT. Each outreach worker has a caseload of about 10–22 patients. Foreign Born In 1999, there were 297 cases in San Diego. The majority of these cases are foreign-born (67%). Immigrants from Mexico and the Philippines comprise 81% of these cases. Participants remarked on the difficulties in collaborating with the civil surgeons used by the Immigration and Naturalization Service for health examinations of individuals adjusting status within the United States. A recent study revealed that screening by civil surgeons varies in quality. A training program for civil surgeons was successful, but there is a great need for ongoing monitoring and education. It was suggested that there should be a national standardized training and certification process for civil surgeons regarding tuberculosis. Housing Programs The committee visited The Bissell House, a state funded housing sponsored by the San Diego County Tuberculosis Control Program and the American Lung Association of the San Diego and Imperial Counties. Non-adherent infectious patients are placed under legal orders to complete therapy. The Bissell House is used when stable housing is an issue for these individuals. Patients remain at The Bissell House until they are noninfectious, which averages between one to several months. The first infectious individual was admitted in April, 1996.

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Page 194 with multiple clinics necessitating screening and enrollment at numerous sites. Santa Clara County (SCC), through a partnership of its TB Program and Ambulatory Care TB Clinic, has been the most successful of the 49 California TB programs that meet eligibility requirements. In 1998, SCC reported 251 cases of TB; 87.6% were foreign-born Asians. SCC evaluates approximately 400 new immigrants per year suspected of having TB overseas (B notification). About 25% of the TB clinic patients qualify for full-scope Medi-Cal benefits. An additional approximately 14% are enrolled in the MCTB program. The annual budget for the TB clinic is $1.4 million. For FY99–2000 SCC is estimating $300,000 in revenue to the TB clinic from Medi-Cal reimbursements for outpatient TB services, including DOT/DOPT. Significant additional savings are gained through direct billing of Medi-Cal for medications and laboratory services. Approximately $100,000 additional income is projected through the Health Care Finance Administration's (HCFA) Medi-Cal Administrative Services reimbursement. SCC's success is due to several factors: two full-time TB clinic “financial counselors,” a dedicated TB clinic; good marketing skills resulting in a win–win approach benefiting both patients and clinical services; development of a strong relationship with DSS; and perseverance. The financial counselors play a key role. At the first visit each patient is interviewed regarding his/her financial status. While some credibility is gained because they are immigrants themselves, the counselors' effectiveness results largely from their knowledgeable, culturally sensitive approach. Patients are told they may be eligible for a variety of programs that will cover the cost of their care. It is clearly explained why enrollment will not prevent the granting of citizenship, and the benefits of coverage, even for non-TB conditions, are emphasized. Patients are assisted with their applications and are told to bring any bills received while waiting for approval to the counselors. It is also emphasized that no one will be denied services based on inability to pay, whether or not they qualify for Medi-Cal. The patients appreciate the concern and assistance with their financial problems. In the face of state and federal categorical TB funding, the MCTB program has enabled SCC to expand and improve TB services. MCTB revenues are paying for the financial counselors and have helped the TB program up-grade several positions. Relationship with Mexico With its close proximity to the Mexican border, the San Diego County Health Department has several programs dealing with border issues.

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Page 195 Cure TB Given the constant movement of individuals between Mexico and the United States, CURE TB was developed to improve continuity care for active tuberculosis patients and contacts whose care spanned the border. The program links health providers in Mexico and the U.S; informing providers of a patient's arrival to the community and by transferring patient medical information. Operated by the San Diego County TB Control Program and funded by the State of California Department of Health Services, the Centers for Disease Control and Prevention, and private funds, CURE TB also provides assistance directly to TB patients via a toll free 1-800 number accessible from both countries. CURE TB works closely with the Mexican Ministry of Health and other U.S. TB programs. As of January 2000, tuberculosis referrals were made between 24 U.S. states and 30 Mexican states. These 24 U.S. states report 90% of all Mexican-born TB patients in the U.S. Baja California-California Binational Tuberculosis Committee The committee provides a forum for regional collaboration between U.S. and Mexican health departments, medical professionals, and community-based organizations. The committee meets regularly and has sub-committees addressing issues of education, epidemiology, binational referrals, and laboratories. Future emphasis will be on contact investigation and binational medical case conferences. Ten Against Tuberculosis This initiative has been sponsored since 1996 by the U.S. Health Resources and Services Administration. Participants include health officials and CBOs from the four U.S. states and six Mexican border states, as well as federal authorities from both countries. The goals of TATB are to raise awareness of border TB issues and to mobilize strategies and resources. Visit to Tijuana, Mexico At the Tijuana Centro de Salud (SSA) we visited the microscopy laboratory which had a modern 2-headed light microscope in excellent working condition (provided Nov 1998 by 10 against TB), a small but clean laboratory and staff well trained in conducting un-concentrated sputum exams. Their meticulous records showing about 20 AFB exams each day. There was no ongoing laboratory quality assurance. The center was also well equipped to perform X-rays (provided in 1995 by San Diego County)

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Page 196 and was performing 10–15 per day. A visit with the treating physician showed ample first line antibiotics being provided by the SSA, well maintained patient records including treatment cards, and a nominal registry provided by the government. A sputum induction room had been provided by a prior study and was not currently being used as it was not felt to improve the yield of un-concentrated smears. A visit to the General Hospital (SSA) demonstrated capacity to perform concentrated smears and inoculate cultures using a Jouan centrifuge and Class II biosafety cabinet (provided by INDRE), and both a regular and fluorescent microscope (provided by “Ten Against TB”). These studies are performed on every hospitalized patient (about 15/day) and when requested by SSA clinics (5/day). Identification and susceptibility were sent to INDRE in Mexico City, but the staff shared data supporting their contention that the turnaround time was commonly too long for appropriate patient care. There was no ongoing laboratory quality assurance. WASHINGTON STATE SITE VISIT AUGUST 5–6, 1999 On August 5–6, the Committee on Tuberculosis Elimination visited Seattle-King County and Tacoma-Pierce County Health Departments to review the successes and concerns in controlling tuberculosis in Washington State. Patrick Chaulk, David Fleming, and John Sbarbaro represented the committee; staffers Lawrence Geiter and Donna Almario also attended. The site visit included an overview of the care provided for tuberculosis cases in Seattle-King County's TB program at Harborview Medical Center, including the DOT program, contact program, and programs targeted towards the foreign born. The committee members also visited Tacoma-Pierce County Health Department, where the public health department has been restructured to now contract TB services to a private practice, Infections Limited. In addition, the site visit group met with State Health Department TB program officers to gain an understanding of the various issues of TB control in Washington State. In the State of Washington, the case rate is 4.7/100,000 while the case rate in Seattle is 7.0/100,000. The majority of tuberculosis cases are foreign born (67%) with most of the patients originating from Asia and Africa. Washington State Funding The state motor vehicle tax may decrease in Washington State. About

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Page 197 $27 million from this tax went towards public health funding, $17 million of which goes to King County. During 1999 and in Seattle, the total budget of the TB program was $1.55 million: 46% was from public (via taxes), 31% was from CDC, and 23% was patient generated. Since 1993, funding from CDC has been level, and funds from taxes have decreased by about 2–3% each year (not taking into account inflation). Seattle-King County Overview In 1998, 116 tuberculosis cases were reported in Seattle-King County. About 58% of the total tuberculosis cases are managed by the Tuberculosis Clinic in Harborview Medical Center. This nurse-oriented clinic has 30 people on staff. Programs DOT Program In Harborview, 80% of the patients are on directly observed therapy (DOT). Each patient receives information on DOT, and Harborview Medical Center provides about half of the medication for those treated in the private sector. Patient No. 1 A homeless patient and outreach worker provided insight into the DOT program managed by Harborview Medical Center. The patient, who is a heroin addict, was first tuberculin skin tested while in jail in 1997. His test was positive, and the jail provided him with one week of INH medication. However upon release, he was not given information on how to obtain additional INH to complete his therapy. He, therefore, discontinued therapy. In 1999, he was coughing up blood, and after a work-up, found to have a positive smear. Given that he was both infectious and homeless, he is being provided housing until he becomes smear and culture negative. Because of the patient's drug addiction, the outreach worker provides medication daily which ensures adherence to therapy. Housing also facilitates dispensing of medication. The patient's outreach worker commented that in terms of ensuring therapy completion and adherence there needs to be more incentives, more case management, more referrals to social services, obtaining results sooner, decreasing the size of pills, and better culture-appropriate educational material for both the patient and outreach worker.

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Page 198 Contact Program Increase in funding for contact programs and cuts in prevention programs reflect that the TB population has changed from that of middle-aged homeless men, to a disease that now affects the foreign born. In Seattle-King County, one public health nurse oversees contact investigation. Thousands of contacts are reviewed, and hours devoted to contact investigation have been increased from 16 hours to 40 hours. In the recent cooperative agreement, an additional outreach worker to assist in contact investigation has been requested. Homeless Program One of 24 sites in the country, Healthcare for the Homeless Network is a shelter-based nursing program that refers individuals to clinical services. More than 50% are families. An outreach worker who works with the homeless individuals with tuberculosis said that trust and confidence encourage therapy completion. He notifies others in the homeless community if he is searching for someone. There is, though, a need for more outreach workers and testing of targeted populations, including injection drug-users. Diverse Populations Since 67% of the tuberculosis cases are foreign born, many of the TB prevention programs in Seattle-King County have focused on the immigrant and refugee population. This programming includes a partnership with community health clinics and initiating programs targeted to diverse populations. For example, Harborview Medical Center works with the International Medical Clinic, a community health clinic that offers a range of services including obstetrics, psychiatric, and acupuncture. Most of the patients are either East African or Asian. The staff is bicultural and bilingual, and physicians are trained in anthropology and public health. Suspect TB individuals are then referred to Harborview Medical Center. In addition, one outreach initiative that is designed to encourage compliance to prophylaxis treatment, specifically targets four of the largest refugee groups expected to enter the region: Bosnians, Russians, Ukranians, and Somalians. Another program, Community House Calls, targets Cambodians, Lao, Latino, Mien, Vietnamese, and Ethiopians. They serve as a mediation between Western medicine and cultural beliefs to assist adherence to therapy. For example, in the Somalian culture, sharing plates and cups during dinner symbolizes the unity of the family and community. TB-infected individuals are unable to dine in this way, and it contributes

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Page 199 to the stigma and the ostracization of the individual from the community. Having tuberculosis is worse than having HIV. However, there have been cutbacks in the refugee screening program. Cuts have been moved towards contact investigation. Other Successes Other successes in Seattle-King County include the following: no report of MDR cases in 1998, higher DOT and completion rates, and finally, number of suspect cases has increased which is being attributed to an increase in provider education. Tacoma-Pierce County Health Department Committee and staff members met with providers and administrators from both the Tacoma-Pierce County Health Department, the County Medical Board, and Infections Ltd., to understand the restructuring of the health department and its effect on tuberculosis services. In 1996, TacomaPierce County Health Department reorganized their health department. This restructuring included privatizing the tuberculosis control program through a contract with an infectious disease specialty group called Infections Limited. Tuberculosis services, then, became part of a clinic network system instead of a categorical system. Under the categorical system, the following were steps in caring for suspect or active tuberculosis cases (Sharma et al., draft): 1) Suspect or active tuberculosis cases are referred to the Health Department TB clinic by community providers. 2) A registered nurse would then examine the patient and a case management plan would be developed. 3) The county tuberculosis control officer, also a pulmonologist, would review all charts, order tests, examine chest radiographs, and prescribe medical treatment. 4) Public health workers would administer DOT. 5) Health department staff would report cases to the state TB control program. With services contracted out the Infections Limited, the steps in taking care of suspect or active tuberculosis cases have been streamlined. 1. Primary care contractors notify the Health Department of tuberculosis cases. 2. The Health Department nurse epidemiologist refers suspect or active cases to Infections Limited. 3. At Infections Limited, specialty doctors would evaluate the case at the initial appointment. The health department pays a capitated rate for the care of each patient with active tuberculosis. Rates include physician and clinic visits, medications, and diagnostic tests. 4. The nurse case manager would provide services to patients through home visits. 5. The public health outreach staff would still provide DOT.

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Page 200 Please refer to the page image for an unflawed representation of this content. TABLE C-1 Cost and Personnel Savings by Contracting TB Clinic Services Description Expended Amount 1996 Expended Amount 1997 Percent Change Personnel including fringe $384,500 232,900 39.4 General and medical supplies $32,600 $3435 89.5 Contractual services $60,000 $124,059 106.8 Other direct program costs $59,300 $18,817 68.3 TOTAL DIRECT COST $536,400 $379,211 29.3 Staffing Levels 1996 FTEs 1997 FTEs Percent Change Nurse 4.3 2.0 DOT/outreach 3.2 1.8 Clerical 1.5 0.95 Medical office assistant 0.4 0.0 TOTAL FTEs 9.4 4.75 49.5 SOURCE: Table provided from document prepared by Tacoma-Pierce County Health Department handout for site visit participants. Under the categorical system, the health department had four providers, only one site, and opened only on certain hours. Conversely, the present clinic network system now has 31 providers, 11 sites, and offers a full scope of services, 24 hours/day. Savings under the present clinic network system are in Table C-1 . In 1998, Tacoma-Pierce County Health Department reported 36 tuberculosis cases. A majority of these cases were born in the U.S. and white. Funding for Tacoma-Pierce County Health Department Tuberculosis program is $821,480 with 12% from state funds and 88% from Pierce County Special. Spending of this is as follows: 40% for TB control, 26% for TB surveillance, 7% for TB assessment, 12% for TB network, and 15% for Infections Limited. Summary The site visit to Washington State provided essential information to the committee. The visit highlighted the importance of culture-sensitive

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Page 201 programs in dealing with an increasing number of tuberculosis cases in the foreign-born population, concern of maintaining funding for tuberculosis programs with potential cuts on state funding, and a new approach in dealing with tuberculosis care in low-incidence areas. STATE OF MAINE SITE VISIT DECEMBER 14, 1999 On December 14, 1999 Sue Etkind represented the IOM's Committee on Tuberculosis Elimination and visited tuberculosis program staff in the State of Maine, accompanied by IOM staff Lawrence Geiter and Elizabeth Epstein. The visit provided an opportunity to discuss tuberculosis services in a rural, low-incidence state. Maine has a low and steadily declining incidence of tuberculosis, but experienced an outbreak of tuberculosis at a local shipyard that involved 21 cases diagnosed between 1989 and 1992 and traced back to a single source case who went untreated for at least eight months. This outbreak generated media attention given that it occurred at a time of a national resurgence of tuberculosis. Over the last five years tuberculosis has declined from 35 cases and a case-rate of 2.8/ 100,000 population in 1994 to 13 cases and a rate of 1/100,000 in 1998 and then back up to 29 cases in 1999. These case-rates are well below the year 2000 interim targets for tuberculosis elimination in the United States and places Maine within striking distance of the goal of elimination, defined as less than one case per million, by the year 2010. Organization of the Visit The visit began with a meeting at the Maine Bureau of Health, where the site visit team received an overview of the Maine public health program and the tuberculosis program from: Joan Blossom, R.N. BSN, Director, Tuberculosis Control Program; Ellen Bridge, Consultant, Public Health Nursing; Kathleen Gensheimer, M.D., M.P.H., TB Program Medical Director; Paul Kuehnert, M.S., R.N., Director Division of Disease Control; Beth Patterson, Consultant, Public Health Nursing; Valerie Ricker, R.N., Community and Family Health; Steve Shapiro, Tuberculosis Control Program; Kim Ware, R.N., BSN, Public Health Nursing, Augusta. The primary objective of this meeting was to get an overview of tuberculosis services in the State of Maine. Tuberculosis services are provided through the Bureau of Health, Division of Disease Control. Clinical services are provided at six clinics throughout the state and staffed by TB consultants contracted by the State (there are no county health departments). One of the clinics has a sufficient caseload to operate weekly, the others are run as needed, but no more than once a month. Support for field services and

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Page 202 patient management comes from Public Health Nursing and one-eighth of the Public Health Nursing budget is spent on tuberculosis even though only about 1% of their client population has tuberculosis. Maine provides for tuberculosis services with a combination of federal and state funds but there is a constant struggle to maintain funding. An example given by the staff of a deficiency in funding is that despite the size of the state, public health nurses are not reimbursed for costs associated with visiting patients. This is a special problem when trying to manage homeless patients, who do not congregate in one area but who are spread throughout the state and can be very mobile. There has been a particular effort to provide training for tuberculin skin testing so that case contacts, foreign-born individuals, seasonal farm workers, and others at risk for infection can be properly tested. This training is also provided by public health nursing staff. This type of training will be vital to support an expanded program of targeted testing and treatment of latent infection. The second meeting was at the Health and Environmental Testing Laboratory, with the following in attendance: Osborne Coates, M.D., Chair Tuberculosis Program Consultants; Steve Shapiro, Tuberculosis Control Program; Julie Crosby, Health and Environmental Testing Laboratory; Joan Blossom, R.N., B.S.N., Director, Tuberculosis Control Program; Kathleen Gensheimer, M.D., M.P.H. Despite the low case-rates and the relatively small caseload, Maine retains an independent mycobacteriology laboratory. There are four full-time staff in the TB lab and in 1999 2500 specimens were processed for tuberculosis and 34 were positive. The laboratory uses genetic probes to identify TB. Federal funding supports one microbiologist and some laboratory supplies but the state laboratory budget pays for the remainder of expenses, with a charge back to the TB clinical program for TB tests. The laboratory has the objective to meet all CDC criteria for rapid turn around on microscopy, culture, and sensitivity tests. The vast majority of AFB microscopy test results are reported within 24 to 48 hours but the laboratory is not open weekends. A continuing problem is that many hospitals use out of state labs, probably due to contracts, and this delays reporting of the results to the clinicians and to the TB program. One way to improve turn-around time for samples processed within the state would be for funding to be made available for a courier service to transport specimens within the state. While travelling to the next meeting, the IOM staff had the opportunity to talk with Steve Shapiro, a Public Health Advisor assigned to the State of Maine by the CDC. Steve works across programs, covering HIV, STDs, and TB. His background has been in STDs and his primary supervision comes from that program. His position, working across programs, is new and presents challenges in training. His focus has been on consultation in program evaluation, using CDC models. He feels that he has been

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Page 203 able to contribute to all of the programs, that there are definitely similarities that run across all of the programs and that his ability to contribute will increase over time. The final meeting was held back at the Bureau of Health with Kim Ware, Public Health Nursing, Augusta; Kathleen Gensheimer, M.D., M.P.H.; Osborne Coates, M.D., Chair, Tuberculosis Consultants; and Steven Sears, M.D., Vice President Medical Affairs, Maine General Medical Center. The focus of this discussion was on the role of the TB consultants. There are nine TB consultants retained by the state and paid $225 per month, plus an extra fee for each clinic session. The consultants meet four times per year and this usually provides adequate time to review all cases under care at that time. The consultants are a mixture of infectious disease and pulmonary specialists and in general feel that they have few problems managing the treatment of cases. The greatest problem was in maintaining adherence with preventive therapy. The largest group on preventive therapy are Bosnian refugees and adherence dropped as soon as they obtained jobs. DOPT has been tried in selective cases but proved not to be cost effective for their program since the number of patients in any single language/ethnic group was so small. Another difficult group to maintain adherence is seasonal agricultural workers. In general, the greatest need seemed to be to identify new strategies to deal with preventive therapy. Before leaving Augusta, the site visit team had the opportunity to attend a portion of a meeting with the state society of the Association of Practitioners of Infection Control (APIC). There was a presentation of a complicated case that highlighted issues about skin testing, timing of discharge from isolation rooms, maintenance of negative pressure rooms, and other infection control issues. The discussion highlighted the problems faced in adhering to the proposed OSHA regulations for TB infection control. The outcome of an inappropriate patient discharge also highlighted the amount of resources consumed through skin testing and other follow-up when infection control guidelines are not followed. The site visit team then went to Portland and met first with management of a local food processing plant and Kathleen Gensheimer, M.D., M.P.H. Two patients with active tuberculosis were identified among the workforce at this company located in Portland. The company management was very cooperative with public health in conducting screening, and later in offering work-site preventive therapy. However, company managers still felt they lacked a great deal of knowledge about tuberculosis and needed outside help to deal with the problem. Despite company cooperation with work-site preventive therapy, completion of therapy rates were very low. The major barriers included language (the employees speak a variety of languages) and the stigma the employees perceived in association with a diagnosis of tuberculosis or tuberculosis infection.

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Page 204 Very few of the employees understood that individuals on preventive therapy only were not a source of infection for others and education was needed in this area to make work-site preventive therapy feasible. The final meeting took place at the Maine Medical Center in Portland with Kathleen Gensheimer, M.D., M.P.H., William Williams, M.D.; Maryann Weston, P.H.N.; and Diane Fanning, R.N. This is the largest TB clinic in Maine and is open weekly. Besides treating active cases the TB clinic works with the international clinic to conduct TB screening for refugees. About 50% of the refugees are tuberculin skin-test positive but completion of therapy rates is difficult and public health nurses make frequent home visits. Again, the problem of maintaining adherence with treatment for latent infection was a major concern. Where the medical consultants we met with in Augusta felt that community knowledge of TB was very low, Dr. Williams felt that it was very high in Portland and that he encountered few problems with poor diagnosis, treatment, or referral in Portland. This may be a residual effect of the outbreak at the ironworks and all of the attention it brought. Summary and Conclusions In general, the tuberculosis program seemed to be functioning extremely well and the system of contact consultants seemed well designed to provide quality care for a widely dispersed population. With the treatment of cases progressing well, there have been a number of efforts to focus on tuberculin testing and treatment of latent infection but adherence and completion of therapy are major problems. The problems the program faces are not medical but rather deal with resources. A large portion of the public health budget is going to tuberculosis and the support for this spending probably is a legacy of the outbreak at the iron works. As the memory of that outbreak recedes, the funding for the program may begin to suffer. Also, resources to expand the program from treatment to prevention of the disease are not available now and will likely be very difficult to come by.