Table 1: Guidance* for developing a written protocol for quality assurance for tuberculosis surveillance data, United States, 2011.
(a) Case detection: Case detection is the discovery of the existence of a single instance of a specific disease or exposure, for example, tuberculosis (TB). This is a front-line surveillance activity and typically accomplished as a by-product of routine medical or veterinary care, laboratory work, or via an astute observer. The primary purpose is to find all patients with TB diagnosis to treat and prevent TB transmission and are reported to the TB surveillance system

ActivitiesDescriptionData sources

Maintain a registry of TB cases.Contains at a minimum the elements to produce data for the national TB case report, the revised Report of Verified Case of Tuberculosis (RVCT).
All local jurisdictions should also have at least a log, if not a registry, that contains key demographic and clinical information on each reported TB suspect.
Data on TB cases receiving diagnostic, treatment, or contact investigation services in the local jurisdiction, although not included in the annual morbidity total, should be included in the TB registry.
(i) TB suspect registries from all local jurisdictions.

Establish liaisons with appropriate reporting sources to enhance quality assurance (QA) of TB surveillance data.Enhance identification, reporting, and followup of TB cases and suspects by establishing liaisons with appropriate reporting sources.
Jurisdictions should provide a plan for case finding and how they will or have established appropriate liaisons.
Thereafter, TB programs should provide periodic feedback and at minimum, an annual written report summarizing surveillance data to reporting sources.
(i) Hospitals.
(ii) Clinics (e.g., TB and HIV/AIDS clinics).
(iii) Laboratories performing tests for mycobacteria.
(iv) Selected physicians (e.g., pulmonary and infectious disease subspecialists).
(v) Correctional facilities.
(vi) Community and migrant health centers.
(vii) Pharmacies.
(viii) Other public and private facilities providing care to populations with or at risk for TB.

Develop and implement active case detection activities.At a minimum, ongoing active laboratory surveillance should be conducted by on-site visits in all areas to ensure complete reporting of all TB cases and suspects with positive acid-fast bacilli (AFB) smears and cultures for M. tuberculosis.(i) Laboratory reports.

Evaluate the completeness of reporting of TB cases to the surveillance system.Periodically (e.g., at least every two years) evaluate the completeness of reporting of TB cases to the surveillance system by identifying and investigating at least one population-based secondary data source to find potentially unreported TB cases.Secondary data source, for example
(i) statewide laboratory record review,
(ii) pharmacy review,
(iii) hospital discharge data review,
Potential TB cases identified during the evaluation must be verified.(i) medical records,
(ii) physician, interviews,
(iii) patient interviews.
Reasons for nonreporting of TB cases should be determined and a plan for improvement developed and implemented.

(b) Data accuracy: Data accuracy means that the data recorded match exactly what happens in a clinical encounter, whether or not it is clinically appropriate. The primary purpose is to identify and correct errors in the surveillance data

ActivitiesDescriptionData sources

Evaluate accuracy/validity of RVCT data.At least annually evaluate the accuracy/validity of RVCT data by comparing RVCT data and the jurisdiction’s TB registry data to original data sources.(i) RVCT data collection form.
(ii) Patients’ medical records.
(iii) TB registry database.

Assess knowledge, skills, and abilities of staff and provide training if needed.Assess the knowledge, skills, and abilities of all existing personnel and new hires whose duties involve the collection and reporting of registry and RVCT data.(i) Personnel files.
(ii) Staff interviews.
(iii) Observations and evaluations of staff skills.
Provide training and evaluation. Training will focus on accurate and timely completion of the revised RVCT. All existing staff will be trained on the revised RVCT data collection, and new staff should be trained within 2 months of hire date.

(c) Data completeness: Data completeness means that the information submitted contains the mandatory set of data items. The primary purpose is to capture all the relevant data on TB patients on the RVCT to support and improve the function of the TB surveillance system

ActivitiesDescriptionData sources

Maintain completeness for all RVCT variables.TB case data will be reported to CDC using the revised RVCT form via an electronic format that conforms to Public Health Information Network (PHIN) and/or National Electronic Disease Surveillance System (NEDSS) messaging standards.
(i) RVCT form via an electronic format.
HIV status will be reported for at least 95 percent of all newly reported TB cases, age 25–44 years.
(i) HIV reports.
A valid genotype accession number (generated by the CDC-sponsored genotyping laboratory) will be reported for at least 85 percent of all reported culture-positive cases.
(i) Genotyping reports.
TB programs will maintain at least 95 percent reporting completeness for all variables existing on the pre-2009 RVCT.
(i) Pre-2009 RVCT form.
By 2013, TB programs will achieve 95% completeness of all variables in the revised RVCT.(i) Post-2009 RVCT form.

Match TB and AIDS registries.Collaborate with the HIV/AIDS program to conduct at least annual TB and AIDS registry matches to ensure completeness of reporting of HIV and TB coinfected patients to both surveillance systems.
Investigate and verify all TB cases reported to the HIV/AIDS program and not reported to the TB program. Update the TB registry and report to CDC as needed.
At least annually assess reasons for incomplete HIV results on the RVCT for each verified case of TB.
(i) TB registries.
(ii) HIV/AIDS registries.
Determine if patients were not tested for HIV or were tested but results not reported to the TB program.
Develop and implement plans for improvement in increasing HIV testing and reporting to patients and TB programs.

(d) Data timeliness: Data timeliness is the speed between steps in the surveillance system. Data are current and available on time. The primary purpose is to ensure that data are available for TB program planning and for appropriate distribution of resources

ActivitiesDescriptionData source

Report all newly diagnosed cases of TB to the CDC according to schedule.Report all newly diagnosed cases of TB to the CDC according to a schedule agreed upon each year, generally monthly, and at least quarterly.(i) RVCT reports.

Submit complete RVCT reports according to schedule.The initial case reports should be submitted generally monthly and at least quarterly.(i) RVCT report.
(ii) Initial case report.
Followup 1 report, which is only for TB cases with positive culture results, should be completed and submitted within 2 months after the initial RVCT was submitted, or when drug susceptibility results are available, whichever is later.(i) RVCT reports.
(ii) Followup 1 (Initial Drug Susceptibility Report).
The followup 2 report, which should be submitted for all cases in which the patient was alive at diagnosis, should have data entered as it becomes available, and it should be complete when the case is closed to supervision. All followup 2 reports should be completed within two years of initial case reporting.(i) RVCT reports.
(ii) Followup 2 (Case Completion Report).

Analyze TB surveillance data at least quarterly.At least quarterly, analyze TB surveillance data to monitor trends, detect potential outbreaks, and define high-risk groups. Produce and disseminate at least an annual report summarizing current data and trends.(i) Surveillance data base.

Evaluate programmatic performance by using TB surveillance data at least annually.At least annually, evaluate programmatic performance by using TB surveillance data to assist in compiling supporting evidence to determine the extent to which program objectives are being met and also to assist in developing strategies for improvement.(i) National TB Indicators Project reports.

(e) Data security and confidentiality: Data security is the protection of public health data and information systems against unauthorized access. Data confidentiality is the protection of personal information collected by public health organizations. The primary purpose of security is to prevent unauthorized release of identifying information and accidental data loss or damage to the systems, while confidentiality is to ensure that personal information is not released without the consent of the person involved, except as necessary to protect public health

ActivitiesDescriptionData sources

Ensure that TB surveillance data are kept confidentially and that all data files are secure.Policies and procedures must be in place to protect the confidentiality of all surveillance case reports and files.(i) Data security and confidentiality policies and procedures of the TB program.
(ii) Surveillance case reports and files.
Policies and procedures to protect HIV test results must conform to the confidentiality requirements of the state and local HIV/AIDS programs.(i) Confidentiality requirements of the state and local HIV/AIDS programs.
(ii) Observation of staff.
Provide training on security and confidentiality of data.

*Adopted from the 2011 cooperative agreement between the Division of Tuberculosis Elimination, Centers for Disease Control and Prevention and all 60 reporting jurisdictions of the National Tuberculosis Surveillance System.