II. Standards and Suggested Practices
A. Protocol for data QA
A protocol for data QA is a planned, systematic approach to implementing data QA policies and procedures that is documented in writing and clearly communicated to CTR program staff. Clear policies and procedures can also provide a solid foundation from which to train new CTR staff and provide continuing technical assistance to current staff. In addition, a protocol facilitates the retention of health department best practices and institutional knowledge, which is especially important in the context of frequent staff changes and other organizational transitions. The components of a protocol can be used as a stand-alone, self-instructional tool or as part of group trainings. Finally, a written protocol can be a useful resource for setting performance standards and monitoring staff through periodic self-assessments or audits.
An effective protocol integrates each of the steps in the CTR data life cycle, from data collection through utilization, with clear statements concerning health department policies, objectives, timelines, staff requirements, technical references, and other resources that articulate the following:
- What needs to be accomplished?
- Why does it need to get done?
- How will it get done?
- What is the schedule for getting it done?
- Who is responsible for doing it?
The development of a comprehensive protocol is time consuming. Health departments may want to begin by assessing their readiness to develop the components of a protocol and then determine how to prioritize the resources and time that they might invest in developing a protocol. Developing protocols one section at a time, with the involvement of the relevant staff members to contribute ideas and material, may be an effective approach. For example, a health department’s protocol for data collection may include step-by-step instructions for collecting and documenting client data, helpful tips for counselors about establishing rapport with clients, CTR data forms, guidance on specific variables, and a data collection checklist.
As illustrated in Figure 2, health department QA protocols for use in data collection, entry, management, analysis, and utilization should be guided by the principle-based standards in this document. Also, health departments should assist CTR service providers by developing guidance and templates for QA procedures. Service providers can then use the guidance and templates to develop site-specific QA procedures manuals (e.g., AIDS Health Project CTR Data Procedures Manual). Implementing effective practices requires the designation of a point person at both the health department and service provider level to coordinate the development, implementation, and periodic updating of a program’s protocol, even if this task represents only a small percentage of that person’s time
Figure 2. Development of health department QA protocols and site-specific procedures manuals for CTR data
Standard A1: Health departments should develop and maintain a protocol for CTR data QA that is guided by the 2009 QA Standards and provides specific guidance for conducting QA at each point in the CTR data life cycle.
Health departments should develop a protocol to provide CTR staff with current, detailed information about standard operating policies and procedures for data collection, entry, management and cleaning, submission, analysis, utilization, and security/confidentiality. In addition to serving as the primary resource regarding standard operating procedures, a protocol allows health departments to systematically monitor their procedures and identify needs or opportunities for revising or developing procedures. The protocol should be easily accessible and familiar to all CTR staff to assist them with training, implementation, monitoring, and oversight of data QA activities at the health department and service provider levels. Health department staff should review and update the protocol periodically. Health departments should consider designating a point person to monitor the development, dissemination, and maintenance of the protocol.
- 2001 Revised guidelines for HIV counseling, testing, and referral
- 2006 Revised recommendations for HIV testing of adults, adolescents, and pregnant women in health care settings
Recommendations to policymakers and health care providers for implementing HIV testing in health care settings.
- Quality assurance guidelines for testing using rapid HIV antibody tests waived under the Clinical Laboratory Improvement Amendments of 1988
Guidance for sites using or planning to use rapid test kits to detect antibodies to HIV.
Guidance to policymakers and service providers for developing HIV CTR services and policies in traditional and nontraditional settings.
Standard A2: Health departments should provide CTR service providers with standard guidance for developing a site-specific manual of procedures.
Health departments should offer guidance to service providers for developing a manual of procedures that provides current and detailed information about policies and procedures related to data collection, management, entry, analysis, and utilization. Guidance for service providers can facilitate the standardization of procedures used by a jurisdiction’s CTR service providers and thus improve the overall quality of the data used for reporting and planning. Health departments may offer guidance in the form of an electronic “workbook” with templates the service provider can tailor to address their site-specific needs and environment. Service providers may develop the manual of procedures as a stand-alone document or integrate it as a module in their comprehensive CTR training manual. Health departments may encourage their CTR service providers to designate a staff member as their data quality point person. This point person could monitor the efforts to develop sections of a manual of procedures and to update the content and materials as needed.
- CTR Data Policy and Procedures Manual‡
A template, developed by state health department staff, which service providers can tailor in developing their own data policies and procedures.
- Counseling, Testing, and Linkages (CTL) Data Quality Assurance Guidelines (San Francisco)
Detailed guidelines for service providers to help them complete data collection forms correctly; includes pictures, screenshots, and common mistakes.
- CTR Program and Procedures Manual Template (San Francisco)
An excellent example of a protocol template that can be easily tailored and that contains comprehensive information on CTR programs as well as data collection and recordkeeping requirements.
Standard A3: Health departments and service providers should establish mechanisms for monitoring their policies and procedures.
Health departments and CTR service providers should develop standard assessment tools and timelines for the monitoring of data QA activities at each stage of the CTR data life cycle. Monitoring procedures should include routine self-assessments in addition to periodic audits of data forms and procedures. Scanning or manual data entry can be monitored by conducting spot checks on a random sample of data entry forms (e.g., cross-checking forms against the computer data file). Service providers should also be encouraged to perform spot checks. The information learned from these checks can be used to identify the patterns of data errors made during data collection or data entry. The percentage of forms needing monitoring may vary by area, depending on the current levels of data quality and performance achieved (i.e., more frequent errors may initially require the checking of more forms); the percentage can be adjusted over time.
- National Alliance of State and Territorial AIDS Directors (NASTAD) HIV counseling, testing, and referral services self-assessment tool for state and territorial health departments
Comprehensive information developed by NASTAD to help health departments assess their responsiveness to 2001 CDC’s Revised guidelines for HIV counseling, testing, and referral; includes information about collecting and entering data.