Quality management has been central to the success and integrity of voluntary medical male circumcision (VMMC) programs since the inception of the program. In 2009, U.S. President’s Emergency Plan for AIDS Relief (PEPFAR) implementing agencies began to offer periodic external quality assurance (EQA) of VMMC programs in collaboration with Ministries of Health and Defense in focus countries, and continuous quality improvement (CQI) become more frequent among site managers and clinical supervisors at implementing partner- and government-operated VMMC sites.
PEPFAR has developed and used standard EQA and CQI tools for these purposes. Project IQ recently updated and adapted these standards-based tools to reflect current standards of practice and emerging safety issues in VMMC. Interactive digital versions of these tools will soon be available for use on any tablet or other compatible device through the CommCare platform. The non-interactive versions of the tools, which can also be used to conduct assessments manually, are provided here.
Key updates and developments that have been incorporated into these versions include:
- Release of the second edition of the World Health Organization (WHO) Manual for male circumcision under local anaesthesia and HIV prevention services for adolescent boys and men (2018) (manual available here)
- Revised PEPFAR guidance concerning HIV testing services (HTS) for presexual youth (PEPFAR 2018 Country Operational Plan Guidance for Standard Process Countries available here)
- Enhanced skin preparation protocols to minimize the risk of infection and tetanus (skin preparation resources are available here)
- Additional standards to ensure injection safety
- WHO prequalification of the ShangRing device for adult and adolescent male circumcision (Public report for ShangRing, including manufacturer instructions for use, available here)
- Revised instrument processing standards following determination that disinfection is not necessary or shown to have any additive benefit prior to instrument sterilization and can corrode instruments (2018 Johns Hopkins/Jhpiego Infection Prevention and Control: Reference Manual for Health Care Facilities with Limited Resources (2018) available here)
- CQI tools organized into distinct levels of urgency, to enable teams to focus on addressing the most pertinent safety issues prior to advancing to standards less likely to affect client safety.
- Multiple minor edits from prior versions, based on feedback about clarity, elimination of redundancy, and addition of more precise criteria for some previously subjective judgements.
Background, recommended use, and links to download paper versions of updated EQA and CQI tools are available below.
External quality assurance (EQA) tools
Background: The purpose of EQA is to rapidly gain a comprehensive objective assessment of VMMC program quality. The following tools are updated versions of instruments used by PEPFAR implementing agencies and most content remains similar to previous iterations that are currently in wide circulation. Organized into Tools A through J along with a descriptive site characteristics tool, each instrument focuses on a specific topic in VMMC service delivery or demand creation. Tools are not ranked in order of importance.
Frequency: Quarterly, semi-annually, annually, or as feasible
Assessors: Stakeholders external to a VMMC site or program, which may include Ministries of Health and Defense, a PEPFAR/funding agency, or “above site” VMMC implementing organization leadership (e.g., regional medical officer). The tools can also be used for internal quality control purposes at a site by program staff from outside that site, including the option of using only specific tools covering areas in which there are concerns.
- Typically intended for assessors to complete all tools in a single visit. Multiple tools may be completed concurrently by different assessors at a VMMC site. Assessors may wish to complete each tool as individuals or in small groups.
- Assessors are most likely to provide timely and complete feedback to site management if they summarize key quality gaps in discussion with site management the same day as the assessment.
- Completed tools may also be shared directly with site management or summarized in a subsequent report to ensure quality gaps are documented and progress can be tracked by the site management and assessors as part of ongoing quality management.
Tools for download:
Site Characteristics Tool
Tool A: SOPs, Guidelines, Policies and Job Aids
Tool B: Facilities, Supplies & Equipment
Tool C: Client Record Review
Tool D: Emergency Management
Tool E: Adequacy of Staffing
Tool F: Surgical Equipment and Procedures
Tool G: Communication to Clients
Tool H: PrePex Procedures
Tool J: ShangRing Procedures (Injected Anesthesia and Flip Technique)
Continuous quality improvement (CQI) tools
Background: The purpose of CQI is to enable VMMC implementers to routinely and consistently manage the quality of their own services to minimize client injury and optimize operations and service. The following tools are adapted versions of existing VMMC and other service CQI instruments. Organized into Levels 1 through 3, instruments are organized in order of decreasing emphasis on client safety, to enable teams to focus on the most critical quality gaps before advancing to standards less likely to affect client safety. This hierarchy is also intended to avoid overwhelming teams with lengthy information collection and a long resulting list of quality gaps, and rather enable rapid triage of issues for remediation.
Frequency: Monthly, quarterly, or as feasible
Assessors: Site managers, clinical supervisors, or other senior staff of the VMMC implementing organization with availability to perform assessments with the necessary frequency.
- Intended for assessors to complete each tool or “level” sequentially. For example, if any standards are not met within Level 1, the assessor would not proceed to Level 2 during that assessment visit; rather, they would complete any remaining questions in Level 1, and report out all identified quality gaps for the site team to address.
- As site quality improves, it is expected that the assessor will observe that all standards are met in at least one level and be able to advance to complete a subsequent level(s) within the same visit, until eventually they are able to complete all three levels in a single visit; however, if previously met standards are missed during future visits, the assessor would again conclude their assessment upon completion of the level with quality gaps and would not advance to subsequent levels during that visit.
- Level 1 contains sub-tools with standards for each WHO recommended surgical and device-based male circumcision method. Assessors will complete only one of these tools per procedure observed, based on the method selected by the provider.
- Assessors may wish to complete each tool as individuals or in small groups.
- Assessors are most likely to provide timely and complete feedback to their site team if they summarize key quality gaps in discussion with the site team the same day as the assessment.
- In addition to reporting feedback to the site team, the assessor and site team may develop a detailed gap-by-gap action plan for rapidly addressing identified quality gaps, ideally prior to the next round of CQI.
- Tools may also be shared directly with site team and/or summarized in a subsequent report.