Male Circumcision Quality Assurance Guidance Expert Review Meeting

WHO Meeting ReportMale Circumcision Quality Assurance Guidance Expert Review Meeting 12-13 November 2007 Montreux, Switzerland... Overview of the Draft Male Circumcision Quality Assuranc

WHO Meeting Report

Male Circumcision Quality Assurance Guidance Expert

Review Meeting

12-13 November 2007 Montreux, Switzerland

Table of Contents

Table of Contents 2

Executive Summary 3

Background 6

Day 1 8

Session 1 8

1.1 Overview of Quality Assurance 8

1.2 Overview of the Draft Male Circumcision Quality Assurance Guide 8

1.3 Country Experiences with Quality Improvement Programmes and Standards Setting 8

1.3.1 Standards-based Management and Recognition: An Innovative Approach to Improving Performance and Quality of Health Services in Limited Resource Settings 8

1.3.2 National Adolescent Friendly Clinic Initiative (NAFCI), South Africa 9

1.3.3 A Standards-driven National Initiative to Improve the Quality and Expand the Coverage of Health Service Provision to Adolescents in United Republic of Tanzania 10

1.4 Process to Develop HIV Care Standards 10

Session 2 11

2.1 Overview of Male Circumcision Standards 11

2.2 Group Discussions and General Comments: 12

Male Circumcision Standards 12

Day 2 13

Session 3 13

3.1 Provider Certification Experiences: JHPIEGO 13

3.2 Discussion on Male Circumcision Provider Certification 13

Session 4 14

4.1 Overview of Accreditation 14

4.2 Male Circumcision Accreditation Discussion 14

4.3 Summary of Recommendations and Next Steps 14

Appendix 1: Agenda 17

Appendix 2: List of Participants 19

This meeting was convened by the World Health Organization Departments ofHIV and Reproductive Health and Research The financial support of the Billand Melinda Gates Foundation as part of the Second UN Work Plan on MaleCircumcision and HIV is gratefully acknowledged

Executive Summary

A World Health Organization (WHO) Male Circumcision (MC) QualityAssurance Guidance Expert Review Meeting was held in Montreux,Switzerland on the 12th and 13th of November 2007 Approximately 30 expertsrepresenting the governments, programme implementers, private sector,surgeons, and international organizations from the USA, Africa, and Europeattended the consultative meeting The majority of the experts were from thefields of HIV and AIDS prevention and quality of health care

The goal of the expert consultative meeting was to review the draftinternational guidance on quality assurance of male circumcision services,guidance on standards and certification of providers

The objectives of the meeting are to:

1 Review and discuss the draft Male Circumcision Quality Assurance Guide;

2 Agree on standards for male circumcision services;

The expected outcomes were:

1 Draft guidance document reviewed and notes for revision detailed; and

2 Consensus on standards for male circumcision services obtained

The background to the meeting was that on March 28 2007 WHO andUNAIDS released policy and programmatic recommendations that malecircumcision should be recognized as an efficient intervention for HIVprevention and that promoting male circumcision should be recognized as anadditional, important strategy for the prevention of heterosexually-acquiredHIV infection in men It is anticipated that demand for male circumcision willincrease and action is therefore required to improve current male circumcisionpractices and ensure that safe services are available to the men and boys thatrequire them If safe male circumcision services are to be scaled up, then it isimperative that appropriate systems are put in place to regulate the delivery ofthe services It is important to define, among other things, who can providethe services, and the minimum standards required in the health facilitiesproviding services

Key Recommendations:

Presentations and discussions were held over the two days andrecommendations were made for the revision of the draft guidance There wasgeneral agreement that the document should be revised to focus and givemore attention to quality improvement and quality assurance of services andless on accreditation The section on providers should also focus more on

assessing and improving provider competencies rather than on certification.Other key recommendations made included the following:

 Introduce a new section outlining national and district level guidance,which will include information on:

 Focus of this section to be on assessing and improving competenciesrather than certification

 Re-order the providers section to include the following key components

in the certification: competency assessment, competency-basedtraining, tasks and providers, certification process and level of healthcare provider

 Involve the in-country certifying bodies in decision making to train physician service providers

non- Include operationalization of certification (certification process) withillustrative approaches added in the manual

 Create a competency table to ensure coverage of all activities (basictraining on minimum package for all and competencies of managers)and re-order to the following headings: counselling, assessment,surgery, record keeping, quality assurance and safety

The next key steps agreed upon were the following:

 Revise the Quality Assurance Guidance and send a revised draft toparticipants by end December 2007

 Pilot the Quality Assurance document in 2 or 3 countries by early 2008.Swaziland, Zambia and Kenya agreed to be pilot countries.

 Convene a regional meeting on the Quality Assurance document by 2ndquarter of 2008

 Develop a male circumcision services quality assessment tool

Three randomized controlled trials in Orange Farm, South Africa; Rakai,Uganda; and Kisumu, Kenya1,2,3 have demonstrated that circumcised menhave about 60% reduced risk of HIV infection from heterosexual intercourse

On the 28th of March 2007 WHO and UNAIDS released policy andprogrammatic recommendations that male circumcision should be recognized

as an efficacious intervention for HIV prevention and promoting malecircumcision should be recognized as an additional, important strategy for theprevention of heterosexually acquired HIV infection in men It is anticipatedthat demand for male circumcision will increase Consequently, action isrequired to improve current male circumcision practices to ensure safe qualityservices are available to men and boys that require these services It isimperative then that appropriate systems are put in place to regulate thedelivery of services It is important to outline among other things, which healthcare workers can provide the services, what are their competencies, and whatare the minimum standards that are needed in health facilities that provide theservices

The male circumcision Quality Assurance Guide under review was beingdeveloped to assist policy makers and programme managers to set up andprovide safe quality male circumcision services The initial draft of the Guidefocused on standards, accreditation and certification of service providers.Transparent and controlled certification procedures help to establish anddemonstrate that the facility is committed to providing safe and effective careand quality services An expert review was convened in Montreux,Switzerland on the 12th and 13th November 2007 to review the draft MaleCircumcision Quality Assurance Guidance

Approximately 30 experts attended the meeting including representatives fromthe governments of Kenya, Uganda, Namibia, Swaziland Lesotho; theCentres for Disease Control, USA; International Council of Nurses; JHPIEGO;Family Health International (FHI); Joint Commission International (JCI);UNICEF; and WHO

Background documents available at the meeting included: a WHO/UNAIDSbackground paper on Male Circumcision: global determinants of prevalence,safety and acceptability, a UNAIDS document on safe male circumcision andcomprehensive HIV prevention programming: Guidance for decision makers

on human rights, ethical and legal considerations, a draft report onEngenderHealth’s experience entitled “Implementing facility-based familyplanning & other reproductive health services; lessons applicable tointroduction of male circumcision for HIV prevention” and UNAIDS Best

1 Auvert B, Taljaard D, Lagarde E, et al Randomized, controlled intervention trial of male circumcision

for reduction of HIV infection risk: the ANRS 1265 Trial PLoS Med 2005;2(11):e298

2 Bailey C, Moses S, Parker CB, et al Male circumcision for HIV prevention in young men in Kisumu,

Kenya: a randomized controlled trial Lancet 2007;369: 643-56

3 Gray H, Kigozi G, Serwadda D, et al Male circumcision for HIV prevention in young men in Rakai,

Uganda: a randomized trial Lancet 2007;369:657-66.

Practice publication on collaboration with Traditional Healers for HIVPrevention and Care in sub-Saharan Africa: suggestions for ProgrammeManagers and Field Workers.

The meeting opening highlighted the goal, objectives and expected outcomes

Goal

The goal of the expert consultative meeting was to review the draftinternational guidance guidelines on standards and certification of malecircumcision services The framework includes sections on the development

of an accreditation programme, certification of providers and standards

The objectives of the WHO Expert review meeting were:

 To review and discuss the draft male circumcision quality assuranceguidance document;

 To agree on standards for male circumcision services; and

 To agree on standards for male circumcision providers

The expected outcomes included:

 Draft document reviewed and notes for revision detailed;

 Consensus on standards for male circumcision services obtained; and

 Consensus on standards for male circumcision providers obtained

Day 1

Session 1

1.1 Overview of Quality Assurance

Joanne Ashton (JCI)

The overall concept of quality assurance was presented Three elements ofquality assurance were outlined for the group: defining, measuring andimproving quality The concept outline highlighted that quality is defined by thestandards Compliance to the standards can then be measured, and qualityimprovement methods used to make improvements where standards are notmet Quality improvement activities need to be undertaken once a gapbetween real and expected performance is identified A definition of qualityassurance was provided: "a set of activities that are carried out to setstandards and to monitor and improve performance so that the care provided

is as effective and as safe as possible" Different approaches of measuringquality were mentioned including: peer assessment; self-assessment;supervisor; certification and accreditation She also touched upon the basicframework on organizing for quality assurance and concluded that qualityassurance is not a vertical program working independently within anorganization but should be integrated with other programmes

1.2 Overview of the Draft Male Circumcision Quality Assurance Guide

Julie Samuelson (WHO)

An overview of the draft guidance was presented She reviewed the key

sections of the draft guidance manual which included:

 Aims, objectives and quality assurance guiding principles

 Ten proposed male circumcision standards that had been developedbased on the minimum service package for male circumcision,programme experience and a literature review

 Guidance on certification of male circumcision practitioners

 Guidance on accreditation of a male circumcision programme

She also shared some comments received from the experts who were unable

to attend the meeting for consideration Ms Samuelson pointed out that eachsection should be reviewed and considered to its appropriateness in thedocument under review

1.3 Country Experiences with Quality Improvement Programmes and

Standards Setting

1.3.1 Standards-based Management and Recognition: An

Innovative Approach to Improving Performance and Quality of Health Services in Limited Resource Settings

Edgar Necochea (JHPIEGO)

Dr Necochea highlighted key challenges for quality improvement in many lowresource settings He mentioned that JHPIEGO has worked in many variedlow resource countries, e.g Brazil, Malawi and Afghanistan and has beenfocusing on finding solutions to problems rather than problem analysis.

Four steps in standards-based management and recognition were describedincluding 1) setting standards, 2) implementing standards, 3) measuringprogress and 4) rewarding achievements The need for developing standardsthat not only tells providers what to do but how to do it was emphasized A tool

is used to measure the standards, which list the performance standard alongwith the verification criteria; a "yes" and "no" format is used Performancefactors that were identified included capability (knowledge, skills andinformation), opportunity (resources, tools and capacity) and motivation (innerdrive and incentives) An important change management strategy is to startwith the easiest task and move on to more difficult ones A multidimensionalsupervision and support system is an important aspect of the approach Avariety of ways to monitor and support change included continuous self andpeer assessments, internal and external assessments, supportive supervision

as well as client involvement and community participation Experience hasshown that repetition is an effective method of transfer of information, thisredundancy ensures compliance Recognition has been found to be aneffective incentive, such as feedback, social and material recognition

1.3.2 National Adolescent Friendly Clinic Initiative (NAFCI), South Africa

Kim Dickson (WHO)

The National Adolescent Friendly Clinic Initiative is a youth friendly serviceprogramme that was implemented in South Africa in response to the HIVcrisis The goal of the programme was to bring a positive behaviour changeamong young South Africans to reduce teenage pregnancy, sexuallytransmitted infections and HIV/AIDS The key aim was to improve the quality

of adolescent health care services at the primary care level

Standards were developed based on various barriers to health care services

as identified by youth, e.g unfriendly providers, lack of privacy andconfidentiality; also taking into consideration the systems for which theservices were provided, e.g the environment, staff competency, availability ofequipment and supplies, and management Quality principles of defining,measuring and improving quality were a foundation of the NAFCI programme.The accreditation process involved a clinic self appraisal followed by animprovement process An external assessment was conducted when the clinicfelt that they had met the standards Recognition was provided forachievement at different levels Clinics achieving 30 - 59% of the standardsreceived a bronze star, those achieving 60-90% received a silver star andclinics that met 90% or greater received a gold star Various tools weredeveloped to support the clinics to implement the standards, including a clinicguide to NAFCI accreditation, a resource directory of available technicalassistance within the provinces, a values clarification manual and areproductive health clinical practice handbook NAFCI also worked in close

collaboration with district health management teams including the nationaland clinic levels Lessons learned from the NAFCI experience included theimportance of the willingness to embrace change at all levels of health careservice management; strong leadership at all levels, full staff involvement andbuy in to the process, and involving youth and the community in all aspects ofservice improvement Additional success factors included development ofclinic quality improvement teams; use of an external facilitator to support theimplementation of the programme and finding innovative means to addresslack of resources.

1.3.3 A Standards-driven National Initiative to Improve the Quality and Expand the Coverage of Health Service Provision to

Adolescents in United Republic of Tanzania

Venkatraman Chandra-Mouli (WHO)The objective of this national initiative was to improve the quality and expandthe coverage of an evidence-based package of health interventions in order toachieve clearly defined health outcomes in Tanzania The Ministry of Healthhad five objectives within the National Adolescent Health and DevelopmentStrategy 2004 - 2008 that aimed at improving the quality and expand thecoverage by building on experiences gained within the country and establishthe policy based on the national standards The first step when developingthe national standards on adolescent friendly reproductive health serviceswas to organize a working group, with a wide consultation of stakeholders, todraft the national standards A draft set of standards was developed, revised,finalized and approved Input and process indicators were developed forobtaining information and advice relevant to adolescent needs, circumstancesand stage of development A handout and facilitator’s guide were developed

to build a positive attitude and clinical / interpersonal competencies A lessonlearned was that all levels of key stakeholders could either help or hinder theinitiative, and thus, it is important to involve them

In concluding remarks, Dr Chandra-Mouli indicated that the followingquestions need to be addressed during the expert review meeting: Whystandards? Should they be internal or external? Who owns and who willtranslate standards into action?

1.4 Process to Develop HIV Care Standards

Paul vanOstenberg (JCI)

Dr van Ostenberg cautioned that standards will always be imperfect, thus it isbest to reach consensus at a particular point in time, so that standards can beused and then, reviewed and revised regularly The basic guiding principlesshould always be acceptable, knowledgeable and evidence-based Thestandards developed should not re-state or duplicate what is in otherdocuments and should state the target audience He pointed out thatstandardization is an on-going process He raised questions such as, how canone show an external evaluator that you have met standards? How do youpackage the standards - is it in accreditation or other related programmes?