Sexually Transmitted Diseases  >  Program Guidelines  >  Surveillance and Data Management

Program Operations Guidelines for STD Prevention
Surveillance and Data Management

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Sections on this page:

• Case Reporting
• Provider-based case reporting
• Laboratory-Based case reporting
• Electronic reporting of laboratory data
• Reporting by out-of-state laboratories
• Coordination
• Laboratory Visitation
• Laboratory Compliance
• Prevalence Monitoring

Case Reporting

Incidence is defined as the number of newly developed cases of disease in a specified time period. The incidence rate is the number of new cases of disease divided by the number of persons at risk during a specified time period. Case-reporting is the process of reporting cases of notifiable STDs by providers and/ or laboratories to local and state health departments and from state health departments to CDC. Case reports remain the most common source of STD surveillance data for state and local health departments.

In addition, the reporting areas share data from case reports with the Centers for Disease Control and Prevention (CDC) via the National Electronic Telecommunications System for Surveillance (NETSS). NETSS collects information on a number of notifiable diseases and injuries that are nationally reportable in the United States for control of these conditions. The Council of State and Territorial Epidemiologists (CSTE) determines which conditions should be nationally reportable to the CDC. Reporting from states and other reporting areas to the CDC is voluntary (except for reports of quarantinable disease, which are required by international regulation). For more information, including record layouts and the NETSS implementation plan, contact CDC's Division of STD Prevention, Statistics and Data Management Branch.

Although most jurisdictions accept a gonorrhea or chlamydia case report from either a clinician or a laboratory, some require that each case be reported from both sources, and reject case reports from a single source. While laboratory-based reporting is essential and more complete, reporting by clinicians should continue to be encouraged to obtain office-based, point-of-care tests for gonorrhea and chlamydia used by providers. Reporting by providers also affords local health departments an opportunity to establish ongoing relationships with community medical providers who serve at- isk populations. These relationships can result in better reporting, expanded demographic and treatment information, identification of problems with the current laboratory reporting systems, and identification of opportunities for additional STD prevention. These data can be used to better define and then target at-risk populations.

All cases of disease should be reported regardless of treatment status. If a program only reports cases of disease that have been treated, they will be under reporting the true number of cases and the incidence rate will be lower.

Provider-based case reporting

All states require that certain STDs be reported by physicians and other health care providers when they suspect that a case has occurred or they have laboratory confirmation. Physicians can use confidential morbidity report systems that allow them to enter basic demographic information which is sent to the local or state health department by mail, dedicated FAX, or electronically. In some areas, use of FAX to report may pose a confidentiality issue. To provide adequate provider reporting and to improve reporting, routine contact with providers and feedback on disease trends in  their area can help them to better understand the uses of data and to be more timely and complete in their case reporting.

The relationship between STD prevention program staff and health care providers should focus on communicating useful information on screening, treatment, and partner management for STDs. The provision of information on case-reporting requirements should be viewed as only one aspect of STD prevention program provider relations. Routine contact with providers and the provision of feedback to providers on reporting may improve the timeliness, completeness, and validity of case reports and may also result in improvements in the quality of STD care. Programs should work with providers to identify systems that may make reporting easier and less time consuming since provider based reporting is more difficult in common diseases like STDs.

Program staff should survey, regularly interact via phone, set up monitoring systems, and visit new providers to introduce themselves and the services available through the local health department in general, and the programs they represent in particular. In some areas it may be necessary to prioritize such provider visits based on morbidity levels and patient populations. Visits should also be used to inform providers of current disease trends within the community; program priorities; their responsibility to report promptly and completely; and to provide copies of treatment guidelines, report forms, pertinent laws and regulations, names of local contact persons; and to answer any questions. Particular attention should be given to the importance of and various methods or systems available for meeting their reporting responsibilities.

Programs should have systems in place to monitor which providers are reporting and at what frequency. If for some reason a provider stops reporting, the program would then be able to detect the deficiency. A computerized provider reporting list can be established that includes the provider, date of diagnosis, and date of report so that accounts can be kept and patterns monitored. This can be used to detect a change in the pattern of reporting and allow the program to rapidly contact the provider to discuss reasons why reporting patterns have changed.

Close working relationships should be established with individual and large medical care providers serving high-risk patients or reporting significant morbidity (delivery hospitals, juvenile detention centers, etc.). Protocols developed with delivery hospitals serving highrisk women might require that all mothers of newborns receive a stat serologic test for syphilis (STS) and that mothers and infants not be released before the results are known. Efforts should be made to obtain "blanket" permission from selected providers to follow up and to interview their patients identified as possibly having early syphilis or other program established priority infections. Programs should offer to provide "feedback" to those medical care providers treating these early syphilis infections and other priority STDs.

Laboratory-Based Case Reporting

Laboratory-based surveillance to support STD case reporting should be conducted by all state and local STD prevention programs. Provider-based reporting should be performed in addition to laboratory-based reporting to capture the growing usage of point of care tests; that is, tests that are rapid, on-site tests for gonorrhea and chlamydia.

Surveillance information can be used to trigger laboratory visits to inform laboratories of their reporting responsibilities, to provide copies of appropriate laws and regulations, to discuss reporting procedures including appropriate mailing address, and to answer any questions the laboratories may wish to raise. Information to be included on laboratory reports slips and timeliness of reporting should be discussed. Laboratories must understand their statutory responsibilities to report all results for which reporting is mandated (e.g., reactive syphilis serologies, treponemal and non- treponemal).

Visits can also be used to identify a contact person, both in the laboratory and in the local health jurisdiction. Local public health laboratory staff should be aware of—and afforded—the opportunity to participate in such visits. Programs are further encouraged to provide information on alternative reporting mechanisms —telephone, dedicated FAX, or electronic—as available and deemed appropriate.

One method of gathering information is to survey laboratories. Laboratory survey formats should be consistent from year to year to allow programs to monitor levels of testing within the community. The information provided will help programs identify high-volume, high-priority laboratories and may help compare reports received throughout the year. Programs using surveys to obtain information from clinical laboratories should establish a mechanism for providing "feedback" to the laboratories. For example, a yearly report could be developed and included with each survey packet that presents and analyzes information obtained from previous surveys. The ability to provide information that spans multiple years would be dependant on the uniformity of the data being collected over time. Such a format does not preclude questions being added or dropped.

Laboratories that report large numbers of positives or serve providers who see high-risk patient populations or practice in high-morbidity communities should be closely monitored and targeted for close working relationships. Such relationships can be particularly useful in identifying and then solving problems. Programs should have a computerized laboratory check list that allows the ongoing tabulation of reports from laboratories with the number of cases of disease reported, date of laboratory receipt, and date reported. This can be used to detect a change in the pattern of reporting and allow the program to rapidly contact the laboratory to discuss reasons why reporting patterns have changed.

STD prevention programs should work with laboratories to routinely collect gonorrhea and chlamydia testing data from both public and private laboratories. The number of gonorrhea and chlamydia tests performed, type of test, and the number positive by sex, age, race, ethnicity, zip code, and provider type, along with the number of laboratories providing data during the reporting period, should be recorded and maintained by STD prevention programs.

Electronic reporting of laboratory data

In general, laboratories are more likely than providers to report STD positive test results. Many clinical laboratories maintain computerized data systems, and many of those include the minimum data elements needed for STD case reporting. Once STD prevention programs define variables and data formats for case reporting, they should make these data formats available to laboratories and begin to ensure complete and timely reporting. STD prevention programs and clinical laboratories should also be working collaboratively to develop or expand their abilities to transmit and to receive electronic line-listed data on all persons with positive tests for case reporting purposes. STD prevention programs need to collaborate with other disease control programs such as TB and HIV/AIDS to maximize the impact on disease control surveillance operations and avoid duplication.

Reporting by out-of-state laboratories

Large commercial laboratories often receive specimens from many states. Many state STD prevention programs have reported that it is difficult to obtain data from out-of-jurisdiction laboratories. With increasing regionalization of commercial laboratories and the centralization of lab services within managed care organizations, out-of-jurisdiction testing may become more common. All of these laboratories should be notified of their legal responsibilities to report notifiable diseases to the appropriate state STD prevention program. State programs can assist this process by providing out- of-state laboratories with information regarding their reporting responsibilities, including  accurate mailing addresses and methods to transmit data. When problems continue, programs should request the assistance of the STD prevention program in the laboratory's home state to resolve the matter.

The Council of State and Territorial Epidemiologists (CSTE) recommends that the following algorithm be used by notifiable disease reporting sources when reporting to public health authorities in multiple jurisdictions (in order of preference):

1. the state where the patient resides;
2. the state where the provider who ordered the test is located if information on a) is missing;
3. the state where the laboratory that received the original specimen is located if information on a) and b) is missing; or
4. the state where the laboratory that performed the test is located if information on a), b), and c) is missing.

In states where laws require reporting to counties, the state and county health departments need to work with laboratories to establish an algorithm.

Coordination

Many laboratories are required to report data to multiple public health programs within the same health department. These public health programs may also request that data be reported in different formats and for different time periods. Collaboration and coordination between the health department programs that receive data from laboratories would improve efficiency of laboratory-based surveillance data and simplify the laboratories' reporting procedures.

Laboratory Visitation

Laboratory reporting that is timely and complete is fundamental to effective STD control efforts. STD prevention programs should develop and maintain close, professional relationships with all laboratories providing STD testing services. Laboratory visits, ongoing dialogue, and surveys performed by STD prevention program staff can be an effective method for informing laboratories of and gaining their support for program objectives. Program size, established priorities, and available resources must all be carefully considered when determining how best to interact with private clinical and public health laboratories.

Public health and private clinical laboratories should be visited at least once yearly and more often if necessary to solve problems or as resources allow. The following suggestions should be carefully considered when undertaking a laboratory visitation program:

• The STD prevention program must develop a visitation protocol that is consistent with established objectives, policies, project area regulatory structure, and available resources. Building support for the visitation program with the appropriate state and local health officials is most important and can  nsure the effective use of protocols.
• The STD prevention program should identify an individual who is responsible for ensuring that all forms of laboratory visitation are performed in accordance with program policy. That person should have experience and knowledge in program policy and laboratory procedures. He or she must be able to work effectively with program managers, laboratory managers, laboratory regulation workers, and DIS.
• The coordinator should work with the laboratory regulatory agency within the state to develop a list of laboratories licensed to perform STD testing and to determine how the programs can be mutually supportive.
• The coordinator should develop a visitation schedule that accounts for competing program priorities, available staff, training needs, priority laboratories, and those with a history of problems. Local public health laboratory staff should be approached and afforded the opportunity to participate in all or in selected visits as their schedules and interest allow.
• When preparing for visits, responsible staff should review the type and level of testing performed, timeliness of recent reporting, and completeness of information reported. The purpose of such a review is to examine enough records to achieve a representative sample of reporting practices. Timeliness of reporting can be determined by calculating the average length of time (number of days) from the date a laboratory receives a specimen until the date the health department is notified of the results. The reviewer should examine the system currently used by the laboratory to report positive findings to the local health jurisdiction. When evaluating the completeness of information provided, the reviewer should carefully examine the information reported and calculate the percent missing on laboratory slips received from the laboratory.
• Laboratory visits should be carefully planned and should be conducted in a professional manner, one that solicits the support of individual laboratories in efforts to control STD. Instead of simply requesting the information necessary to complete a visitation record and reminding laboratory staff of their reporting responsibilities, program staff should be prepared to discuss recent morbidity trends, program priorities and objectives, and the important role played by laboratories in achieving those objectives. Laboratory staff should also be given the opportunity to ask questions.
• Selection of staff to visit laboratories should be done in cooperation with appropriate supervisors. Those selected must be appropriately trained. Training should include information on arranging visits, how to conduct a visit, how to address laboratory noncompliance issues, how to arrange follow-up visits, materials that should be left with the laboratory, and how to respond to questions where the health department representative does not immediately have the answer. Responsible staff should be well versed in the various methods available for the laboratory to report findings, and provide suggestions or alternatives (given resource availability) to comply with reporting timeliness, i.e., priority mail, FAX, or electronic reporting.
• STD representatives should be responsible for scheduling appointments to visit assigned laboratories. If this is the first time the health department representative has visited laboratories, he or she should be accompanied by an experienced employee on the first few visits. The coordinator or supervisor should monitor the health department representative to ensure that visits are conducted completely, promptly, and tactfully.
• The approach used during the visit should be at all times tactful. Data on the number or percentage of reactive serologies and other STDs identified for a recent reporting period by laboratory reporting in general or by the visited laboratory specifically and recent data for the specific laboratory on the timeliness and completeness of recent reports received should be presented. Tact should be a prominent aspect of the discussion at all times, both in discussing past reporting and in requesting information to be collected.
• The STD prevention program should determine the information to be collected and develop a visitation record to ensure that said information is uniformly collected. Data to be collected is at the discretion of the STD prevention program but should, at a minimum, include: the date of the visit, the different STD tests performed, the total number of tests performed, and the number of positives for a specific time period. Other information that might be collected includes information on the number of tests sent out of state, on those performed for out-of-state providers, on quality assurance measures, and on the names of high volume or high case reporting providers. Programs are encouraged to enter information obtained from laboratory visits into computers so that information can be easily followed and updated over time. For this reason, the information collected from laboratories should remain uniform from year to year to simplify analysis.
• The coordinator should review all completed laboratory visitation records for completeness and accuracy before data entry. All questions, missing information, or identified training needs will be directed back to the appropriate supervisor.
• The coordinator should maintain a file of licensed laboratories that perform STD testing and copies of all visitation records. These records can be updated as necessary and used to identify appropriate laboratory staff when problems arise. The coordinator should work in concert with appropriate state laboratory licensing bodies and with local program officials to address reporting problems.

The results of laboratory evaluations should be routinely reviewed by the lab visitation coordinator and by the STD prevention program manager (See Appendix S-C for a sample Serology Laboratory Site Visit Report and Appendix S-D for a sample Clinical Laboratory Survey).

The intent of a laboratory survey is to identify those laboratories processing tests for STDs, to reinforce laboratory disease reporting requirements, to validate general testing volume including positive tests, and to determine specific high-volume laboratories. Designed in conjunction with staff from the public health laboratories, the survey may provide valuable quality assurance information about laboratory implementation of improved technology. The state laboratory licensing agency usually can provide a list of laboratories, often in electronic format. A survey of laboratories conducted by mail may be relatively inexpensive and may provide data for program evaluation. For example, it is important to determine if a downward trend for a specific disease reflects a true decrease in morbidity or whether it actually represents a decrease in testing.

Laboratory Compliance

The following steps should be implemented in an effort to ensure proper laboratory compliance with existing reporting requirements.

• Develop a response that is consistent with program policy, local health department protocol, and the existing regulatory structure. Involve program staff, the STD prevention program director, other appropriate local health officials, and the laboratory regulation office. Local health officials and the regulatory office can be very helpful, particularly with regard to information they require before they can take official action.
• Ensure that appropriate health officials are kept fully informed of and involved in all efforts to gain laboratory compliance.
• Once an appropriate protocol has been developed for laboratory visitations, assure appropriate personnel review and approve it prior to initiating laboratory visitations.
• The approved protocol should include a method of notifying the laboratory of any failures to meet mandatory requirements. The laboratory should be notified in writing, and a timeline for corrections and follow-up visits should be included. The timelines and specifics as to how the follow-up visits are conducted are local decisions.
• If the laboratory is unresponsive or continues not to meet mandated requirements, the laboratory regulation office should be informed. There should be a policy with the regulatory office and a defined set of procedures to follow after notification.
• Reports from the laboratory should be closely monitored during the next several months to ensure that they are now in compliance and to ensure that they do not regress.

Prevalence Monitoring

Prevalence of a disease or infection is defined as the proportion of persons in a population who have that disease or infection at a defined point in time. Prevalence monitoring is the observation of trends in prevalence in defined populations over time.

In contrast to case-reporting, which is intended to cover all health care providers and laboratories, prevalence- monitoring is most commonly performed using data obtained on selected populations. These prevalence data are usually systematically collected from routine screening rather than case-based surveillance activities performed for the primary purpose of assessing overall disease burden.

This activity is performed by state and local health departments in collaboration with providers and laboratories; in many instances these data are also reported to CDC. Prevalence monitoring has been used in the Regional Infertility Prevention Program for the surveillance of gonococcal and chlamydial infections as well as in GISP for the surveillance of resistant gonorrhea.

Because prevalence-monitoring demands more resources than case-reporting, the participation of providers needs to be actively sought by the health department, often in collaboration with Regional Infertility Prevention Projects. For percentage of positive test results to be a valid estimate of prevalence, providers must routinely screen the target population. If diagnostic testing is included, the estimate will be biased and not reflect the true prevalence of disease in the target population.

Laboratories can be the primary source of prevalence monitoring data if the laboratory routinely receives data on sex, age, and provider type on persons testing positive and negative for chlamydia or gonorrhea. State and local STD prevention programs should work closely with their surveillance staff to collect these data. The purposes of prevalence monitoring, e.g., monitoring the effectiveness of chlamydia and gonorrhea prevention programs, must be communicated to laboratories. The state and local statutes that provide the authority for public health surveillance, including in some cases the authority for obtaining data on both positive and negative test results, should be provided and discussed with laboratories, and written procedures for data security and confidentiality should be provided and discussed. As the morbidity of a particular disease begins to decrease, negative test information will provide programs an additional indicator to determine if the decrease is real.

Unlike chlamydia and gonorrhea, positivity or prevalence of reactive serology for syphilis is not a measure of active disease in the community. Serologic tests for syphilis remain positive for long periods after infection is treated. Clinical information in combination with the patient's past serologic and treatment history need to be evaluated to determine if infection is present. In addition, it is sometimes necessary to determine the infection status of sex partners.

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