Tool to Assess Site Readiness for Initiating

Tool to Assess Site Readiness for Initiating Antiretroviral Therapy (ART) or Capacity for Existing ART Sites

© 2007 by John Snow, Inc. All rights reserved. Any use or adaptation of these materials must acknowledge John Snow, Inc. Any commercial use of these materials is prohibited.


Version 1.3 May 2007



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JSI Established in 1978, JSI has successfully managed more than 500 projects in 102 countries in Africa, Asia, the Caribbean, Central Asia, Eastern Europe, Latin America, the Middle East, and North America. JSI and its affiliate, JSI Research & Training Institute, operate form 47 offices located around the world.

JSI's staff is dedicated to improving the health of individuals and communities through public health projects in the United States and around the world. Our broad-based approach combines the expertise and innovative talents of JSI's more than 2000 staff with local partners to allow countries, communities, families and individuals to develop their own skills and identify solutions that address their public health needs.

Recommended Citation

Hirschhorn, Lisa, Andrew Fullem, Michael Farabaugh, and Marilyn Noguera. 2007. Tool to Assess Site Readiness for Initiating Antiretroviral Therapy (ART) or Capacity for Existing ART Sites, Version 1.3. Boston, Ma.: John Snow, Inc.

Version 1.3 John Snow, Inc. Boston, Ma. © 2007 by John Snow, Inc. All rights reserved. Published 2007. Version 1.2 © 2004 by John Snow, Inc. Developed by Hirschhorn, Lisa, Andrew Fullem, Christopher Shaw, Wendy Prosser, Michael Farabaugh, and Marilyn Noguera. 2007. John Snow, Inc., and JSI/DELIVER Project for the U.S. Agency for International Development. DELIVER, a five-year worldwide technical assistance support contract, implemented by John Snow, Inc. (JSI), is funded by the U.S. Agency for International Develop-ment (USAID). DELIVER strengthens the supply chains of health and family planning programs in developing countries to ensure the availability of critical health products for customers. Any use or adaptation of these materials must acknowledge John Snow, Inc. Any commercial use of these materials is prohibited.

John Snow, Inc. 44 Farnsworth St. Boston, MA USA Phone: 617-482-9485, Fax: 617-482-0617 Email: HIV and [email protected], Internet: www.jsi.com



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Introduction Rapid scale-up of antiretroviral therapy (ART) has been widely recognized as a global need and efforts have been increasing dramatically over the last few years. While scale-up needs to be rapid, it is also critical to ensure that ART programs are able to deliver safe, effective, and uninterrupted care and treatment. This tool was designed to provide sites and programs with a set of criteria to assess a site's readiness to implement ART or the current capacity and needs of an existing program, and to identify key areas that need strengthening. This tool can provide a rapid baseline assessment for sites planning implementation of an HIV treatment program, or be used to assess needs for programs which have already started ART. The tool can also be used by programs to continually reassess site capacity and ongoing strengthening needs over time. Identifying critical gaps that may present barriers to safe and effective ART provision will allow programs to develop plans or make changes to current activities and scopes of services. Areas that need attention are considered at three potential program phases on : if they present a barrier to (1) initiation of the program or (2) providing qual-ity of HIV care within an existing effort or (3) to achieving the longer term goals of the treatment program such as capacity, expansion, and sustainabil-ity. The goals of this tool are to assist sites and programs in rapidly assessing the critical elements for effective care system and delivery, and identifying those elements that need implementing or further strengthening or develop-ment. Site needs will change over time as programs move from ART pro-gram implementation and strengthening to maintenance and expansion. Some sites may be able to or have already started treatment while, simulta-neously, working on critical areas to ensure that they are able to place and maintain the planned number of people on safe and effective ART. The tool can also be used to identify areas in which sites can serve as resources for other local, national or regional efforts.

Finally, the tool can help programs select sites to start or expand ART based, not on site type, but on capacity, vision, and activities needed for ra-tional introduction and expansion of ART. The current version of this tool has also been modified from earlier versions to allow for reassessment of sites after program implementation or strength-ening. This tool can also be found on the JSI website. The tool can be used for site self-assessment or by external reviewers or program directors to as-sist sites, programs, and donors to identify areas that need technical assis-tance and to assist programs in selecting sites for ART introduction and scale-up. In some countries, the tool has been used for monitoring, accredi-tation and/or quality improvement of sites already providing ART. It is not meant to present a barrier to sites but rather to offer an opportunity to work towards start-up or scale-up. The assessment results should be used to de-velop work plans to start ART-related preparedness activities or improve existing services for sites based on the belief that every care site has the ca-pacity to contribute to increasing access to safe and effective ART for all those in need. In many settings, initial ART provision focused primarily on adults. As ac-cess to ART expands and new sites are initiated, increased efforts are being made to treat children living with HIV and AIDS. If a site plans to treat chil-dren, capacity may need to be assessed separately for some aspects of adult and for pediatric care. A supplemental tool specifically addressing the needs of pediatric HIV treatment programs can also be accessed from the JSI website (www.jsi.com). For a site planning on providing integrated family-centered HIV care, it is recommended that both tools be utilized to-gether.



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How to Use this Tool An organization can be considered a system of related components that work together to achieve an agreed-upon mission. The domains defined in this tool represent areas that most organizations involved in development work, particu-larly in relevance to HIV and AIDS related care, are familiar. However, there may be some variation according to the type of organization, the staff, and the context in which it operates. It is strongly suggested that the questions be adapted to suit the local context. The tool reviews program readiness/organizational capacity under six domains: 1) Site Leadership and Model; 2) Services and Clinical Care; 3) Health Infor-mation Management, Monitoring, Evaluation, and Quality; 4) Human Re-source Capacity; 5) Lab Capacity; and 6) Drug Management and Procure-ment. Each domain has specific areas that help define capacity within the domain. Information can be extracted through group discussion between rep-resentatives of community organizations and external evaluators. The evalua-tion of these areas within the domains and the overall score determines which of the five stages a program falls into. The stages rating system can be used to identify steps needed to advance a site along different stages, from the Begin-ning Site (Stage 1) to the ultimate stage of Expansion and Resource Site (Stage 5). The tool begins with the organization profile, which can be completed with the help of key staff members from the organization. In each capacity area a set of probable questions has been provided which can assist in extracting the relevant information to score the area. For organizations with very low or very high capacity the answers to certain questions may be obvious. These questions could be completed without asking participants, to avoid repetition or the risk of discouraging groups with low capacity. The judgment of the evaluation team is critical to the assessment.

Each area in a given domain should be scored in light of the collected informa-tion and through discussion between the evaluators. The rating scale for each area goes from 1-10, depending on the stage of development of the organization in that particular area. Each area should be rated based on a review of the site and interviews with key staff and other stakeholders. The information needed to complete the tool can be found in page 34, Deter-mining a Site’s Readiness. Scores in an area are cumulative—higher scores in an area assume that all criteria for a lower score have been met. At the end of the tool, examples of technical assistance, training, and resources that may be needed to advance a site to a higher stage are suggested for each rating. We would like to hear from you— We hope this tool will be useful. If you have any comments, feedback, or sug-gestions for improvement based on use in the field, we want to hear from you. We will continue to make changes to future versions, and would like to incor-porate your ideas. Please send any comments to the attention of the HIV and AIDS Center at HIV and [email protected].



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Domain 1: Site Leadership and Model Area

1.1 Leadership Has no identified leader that has the authority, responsibility, or ac-countability at site or in community.

Has a leader that has some authority, responsibility, or accountability for ART service provision at some level at the site.

Has leader with vision and some experience managing health care-related services, but needs some assistance with designing and setting up a number of services and protocols.

Has leader with vision and experience managing HIV- related health care programs, and is engaged in establish-ing or running an ART site.

Has strong leader who is spearheading ART services. Able to focus on training leaders for satellite sites or other sites

1 2 3 4 5 6 7 8 9 10

1. Is there an identified leader or leadership team at the site/program and/or in the community who has the authority, responsibility and accountability for the clinical and program management HIV care and treatment program including ART? (may change as program gets underway)

[1] Yes → Proceed to Question 2

[2] No → Proceed to Area 1.2 Model of Care - [Domain 1. Area 1 - Score 1-2] 2. Does the identified leader(s) have experience managing health care-related programs/services?


[2] No → Proceed to Area 1.2 Model of Care - [Domain 1. Area 1 - Score 3-4] 3. Does the management level need assistance designing and setting up protocols, and/or finalizing services and starting to implement the ART program?

[1] Yes → Proceed to Area 1.2 Model of Care - [Domain 1. Area 1 - Score 5-6]

[2] No, no assistance is required → Proceed to Question 4 Is the identified leader or leadership team actively involved in establishing or running an ART site?


[2] No → Proceed to Area 1.2 Model of Care - [Domain 1. Area 1 - Score 7] Does the site have a spearheading ART services?

[1] Yes → Proceed Question 6

[2] No → Proceed to Area 1.2 Model of Care - [Domain 1. Area 1 - Score 8]

6. Is the leader engaged in training for satellites or other sites?

[1] Yes → Proceed to Area 1.2 Model of Care - [Domain 1. Area 1 - Score 10]

[2] No → Proceed to Area 1.2 Model of Care - [Domain 1. Area 1 - Score 9]

Domain 1.1 Score: ________



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1 Model of care includes (1) what will constitute the spectrum of care; (2) target population; (3) adult care protocols; (4) vertical or integrated service provision; (5) SOPs for non-ART HIV services that will be provided on-site, including VCT, PMTCT, OI prophylaxis, TB, STI, management of patients not on ART. Is there an identified potential or actual model of HIV care and treatment for the ART program?


[2] No → Proceed to Area 1.3 ART-Specific Protocols [Domain 1. Area 2 - Score 1-2]

2. Is assistance needed in adapting model of care to the site? [1] Yes → Proceed to Area 1.3 ART-Specific Protocols [Domain 1. Area 2 - Score 3-4]

[2] No, no assistance is required → Proceed to Question 3

3. Please select the option that best reflects the site’s Standard Operating Procedures (SOPs) condition:

[1] Details lacking for most or all SOPs or task assignments in practice or in writing → [Domain 1. Area 2 - Score 5]

[2] Some SOPs exist in practice, but most have not been drafted → [Domain 1. Area 2 - Score 6]

[3] Some operating procedures around HIV care to be provided are still being drafted or finalized → [Domain 1. Area 2 - Score 7-8]

[4] Standard Operating Procedures are both formalized and approved; can serve as a model for other sites [Domain 1. Area 2 - Score 9-10]

Domain 1.2 Score: _______

1.2 Model of HIV Care1

Has not identified any potential models of HIV care and treatment for the ART program.

Has identified some poten-tial models of HIV care that could be adapted to include ART but needs assistance in adapting or implementing to reflect realities of current site ca-pacity.

Has chosen or adapted a Model of HIV care but lacks details for some/all standard operating proce-dures (SOPs) or task as-signments; some SOPs ex-ist in practice, but most have not been drafted.

A detailed model exists, but may need modification based on current or expand-ing needs some operating procedures around HIV care to be provided are still being drafted or finalized.

Detailed model of HIV care other than ART and operat-ing procedures both formal-ized and approved; has been able to be adapted to ex-panding demands; can serve as a model for other sites.

1 2 3 4 5 6 7 8 9 10

Domain 1: Site Leadership and Model, continued

Area



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Domain 1: Site Leadership and Model, continued

Area 1.3 ART-specific Protocols2

May have experience with non-HIV medical care protocols, but no knowledge of or access to any national or other HIV Protocols for most areas.

Has experience with some HIV-related care protocols but limited experience with ARV protocols. Access to protocols for many aspects of care still not available. Some services and proto-cols may have been estab-lished, but the majority still need strengthening.

Has access to national or other ART protocols but have not been fully adapted to the site in all areas.

Has working protocols for all areas in HIV services but may need modification to better reflect site and patient needs and capacities and/or some have not been finalized.

Has approved protocols for ART and HIV care which reflect capacity of site and needs of patient population. These can serve as resources for other sites establishing programs

1 2 3 4 5 6 7 8 9 10

2 These include eligibility and exclusion criteria and procedures, screening and enrollment, regimens, adherence promotion, prescribing and dispensing, monitoring and evaluation, treatment failure, and when to change.

1. Does the site have experience using HIV medical protocols (i.e. CTX, VCT, PMTCT, etc.)? [1] Yes → Proceed to Question 2

[2] No → Proceed to Domain 2: Services and Clinical Care - [Domain 1. Area 3 - Score 1] 2. Does the site have access to national or other HIV protocols for most areas?


[2] No → Proceed to Domain 2: Services and Clinical Care – [Domain 1. Area 3 – Score 2] 3. Does the site have some limited experience with ARV protocols?


[2] No → Proceed to Domain 2: Services and Clinical Care - [Domain 1. Area 3 – Score 3]

4. Does the site have access to protocols for most aspects of care?





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5. Does the site have working ART protocols? [1] No, not at all → Proceed to Domain 2: Services and Clinical Care - [Domain 1. Area 3 – Score 5] [2] Partially → Proceed to Domain 2: Services and Clinical Care - [Domain 1. Area 3 – Score 6] [3] Almost all or fully → Proceed to Question 6

6. Have protocols been approved?



7. Have protocols been modified in the past year?



8. Can they serve as models?

[1] Yes → Proceed to Domain 2: Services and Clinical Care - [Domain 1. Area 3 - Score 10]

[2] No → Proceed to Domain 2: Services and Clinical Care [Domain 1. Area 3 - Score 9]


Total Leadership Points: ______

Leadership: Domain Score (Total Leadership Points / 3): ________



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Domain 2: Services and Clinical Care Area 2.1 Comprehensive HIV Care Ser-vices Other Than ART3

Has very limited HIV primary care or other important services either on-site or through link-ages.

Has access to VCT on-site or by referral; provides HIV primary care or other outpatient HIV-related medi-cal services on-site; inadequate capacity to ex-pand services to meet current site HIV model of care with-out technical assistance.

Has most HIV services as defined by site model of care either on-site or though link-ages and developing linkages to other key services where gaps still exist; able to meet most current needs.

Has all HIV services as de-fined by site's model of care either on-site or through link-ages; needs resources and technical assistance to meet future needs.

Has on-site essential services for ART program in-cluding supportive counseling, patient education, monitoring, screening, OI prevention, and treatment; has full scope of other services on-site or has coordinated linkages to these services4; able to serve as model for other sites and plan-ning for future.

1 2 3 4 5 6 7 8 9 10 3 Comprehensive services important or recommended for ART programs include many aspects of comprehensive HIV care: VCT, HIV primary care, ability to screen for eligibility for ART (VCT, clinical, lab), monitoring and management of toxicities and treatment failures, adherence support, prevention and management of OIs including TB (on-site or by referral), linkage with inpatient care, STI management, PMTCT, supportive counsel-ing, home-based care patient education, adherence support and monitoring, and linkages to other needed services (food/nutrition, transportation, etc.). All services should be provided on-site through close linkages with other programs. Other services that should be available through linkages or on-site include family planning, prevention counseling, and home-based care. Pediatric services should be linked to essential primary care including immunizations, growth monitoring, access to supplemental nutrition, etc. 4 VCT, HIV primary care, pediatric HIV care, OI prevention and treatment, STI management, PMTCT, TB management, counseling, nutrition counseling, linkage with inpatient care, access to assistance with concrete support, (food, transport, housing), home-based care, family planning, and positive prevention.

1. HIV primary care or other important services are either non-existent or very limited. [1] HIV primary care and other services are very limited→ Proceed to Area 2.2: Delivery of ART - [Domain 2.1 Score 1-2]

[2] HIV primary care or other important services either on-site or through linkages are very limited → Proceed to Question 2

Does the site provide HIV primary care and other HIV medical care services on-site? [1] Yes → Proceed to Question 3

[2] No → Proceed to Area 2.2: Delivery of ART - [Domain 2. Area 1 - Score 3]

3. Does the site have capacity to meet the current model of care without technical assistance? [1] Yes → Proceed to Question 4


Continued...



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4. Does the site have most of its HIV and ART scope of services, as defined by the site’s model of care, available either on-site or through linkages? [1] Yes, all services → Proceed to Question 5

[2] Most services → Proceed to Area 2.2: Delivery of ART - [Domain 2. Area 1 - Score 6]


5. Is the site developing linkages to other key services where gaps still exist? [1] Yes → Proceed to Question 6


6. Is the site able to meet future needs without additional external needs and resources? [1] Yes → Proceed to Question 7


7. Are there on-site essential services for ART program including support counseling, patient education, monitoring, and management of toxicities, and treatment failure?

[1] Yes → Proceed to Area 2.2 Delivery of ART - [Domain 2. Area 1 - Score 10]





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Domain 2: Services and Clinical Care (continued)

Area 2.2 ART Delivery 5

Has no services in place to provide ART and no work has begun to develop capac-ity.

Has developed or begun to develop services required for ART in areas such as adher-ence support, patient follow-up, patient education, clinic and patient readiness pro-grams; if developed or under-way, needs significant work/strengthening.

Has developed many services and may already started in critical areas for ART includ-ing patient education, adher-ence support, initiation and follow-up; still require some strengthening in these and other areas.

Has most/all components of ART program, but areas need strengthening and/or expansion for sustainability; limited capacity for future needs/expansion.

Has all components of ART program and working to con-tinue to expand; modify, and improve to meet growing and changing demands of patients in care and population being targeted. Able to serve as re-source for other sites.

1 2 3 4 5 6 7 8 9 10 5 These include prescribing, dispensing, evaluation, and management of side effects and treatment failure; adherence assessment and support; process for identifying and outreach for missed visits; and manage-ment of TB while on ART for adults and pediatrics, as appropriate.

1. Has the site begun to develop required services? [1] Yes → Proceed to Question 2

[2] No → Proceed to Area 2.3: Physical Space - [Domain 2. Area 2 - Score 1-2]

2. The site has begun to develop the services required for ART (adherence support, patient follow-up, patient education, OI prophylaxis clinic, and pa-tient readiness programs) but these services still need significant strengthening.



3. Has the site developed services and is ready to start in critical areas for ART including patient education, adherence support, initiation and follow-up? [1] Yes → Proceed to Question 4


4. Does the site have most/all components of the ART program? [1] Yes → Proceed to Question 5


5. Does the site have all components of the ART program and is working to continue to expand, modify, and improve to meet growing and changing demands of patients in care and in the population being targeted?

[1] Yes → Proceed to Area 2.3: Physical Space - [Domain 2. Area 2 - Score 9-10]

[2] No → Proceed to Area 2.3: Physical Space - [Domain 2. Area 2 - Score 8]




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Domain 2: Services and Clinical Care (continued) Area 2.3 Physical Space6

Has no space for expan-sion of HIV services to include ART, no confiden-tial space, and no plan for location or expansion.

Extremely limited space in use or identified for use by HIV program, limited or no confidential space. Working to iden-tify space for program.

Has limited space available for ART program including at least one confidential area, but space constraints will or does limit enrollment over the coming year.

Has space for ART and confi-dential space (adequate for years 1 -2), but overall space will re-quire expansion in next few years. Some expansion plans may be under discussion.

Has defined and adequate clinic space for ART program includ-ing access to confidential space. Plans are in place to accommo-date patients as program contin-ues to expand.

1 2 3 4 5 6 7 8 9 10 6 Physical space includes confidential space for examinations and counseling. Other important space needs as program develops includes space for staff (work, office, meeting) and space to accommodate integrated services.

1. Does the site have space for expansion of HIV services to include ART?

[1] Yes → Proceed to Question 1a

[2] No → Proceed to Area 2.4: Community Involvement - [Domain 2. Area 3 - Score 1] 1a. Does the site have a plan for location or expansion?


[2] No → Proceed to Area 2.4: Community Involvement - [Domain 2. Area 3 - Score 2] 2. If limited space is identified or available, is the site working to identify additional space for the ART program?


[2] No → Proceed to Area 2.4: Community Involvement - [Domain 2. Area 3 - Score 3-4] 3. Does the site have at least one confidential area to see patients?


[2] No → Proceed to Area 2.4: Community Involvement - [Domain 2. Area 3 - Score 5] 3a. Will the site’s space constraints limit initial enrollment into the ART program?

[1] No → Proceed to Question 3

[2] Yes → Proceed to Area 2.4: Community Involvement - [Domain 2. Area 3 - Score 6]

Continued...



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4. Is the overall and confidential space adequate for years 1 and 2? [1] Yes → Proceed to Question 4a

[2] No → Proceed to Area 2.4: Community Involvement - [Domain 2. Area 3 - Score 7] 4a. Will the overall space require an expansion in the next few years?

[1] No → Proceed to Question 4b [2] Yes → Proceed to Area 2.4: Community Involvement - [Domain 2. Area 3 - Score 7.5]

4b. Are some expansion plans under discussion?


[2] No → Proceed to Area 2.4: Community Involvement - [Domain 2. Area 3 - Score 8] 5. Does the site have a defined and adequate clinic space for the ART program, including access to confidential space?


[2] No → Proceed to Area 2.4: Community Involvement - [Domain 2. Area 3 - Score 9] 5a. Are plans in place as program continues to expand?

[1] Yes → Proceed to Question 6 - [Domain 2. Area 3 - Score 10]

[2] No → Proceed to Question 6 - [Domain 2. Area 3 - Score 9.5]




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Domain 2: Services and Clinical Care (continued) Area 2.4 Community Involvement

No community network, involvement, or support established and limited or no efforts underway.

Efforts underway and initial linkages with community organizations established.

Linkages with community organizations and NGOs un-derway; community leaders contacted; needs assessment underway; PLWHAs en-gaged in care system formally or informally and plans for more community outreach.

Community networking established between stakeholders in areas of health admin., government, commu-nity activists, faith-based or-ganizations, etc.; active involve-ment of PLWHA groups.; lim-ited referral system.

Networking has developed into formal referral or commu-nity collaboration; has full buy-in of stakeholders including PLWHAs, traditional healers, govt. admin., other service organizations, and community leaders.

1 2 3 4 5 6 7 8 9 10

1. Has the site established or initiated a community network, community involvement, or community support?


[2] No → Proceed to Domain 3: Management and Evaluation - [Domain 2. Area 4 - Score 1-2] 2. Has the community clearly demonstrated interest in the site?


[2] No → Proceed to Domain 3: Management and Evaluation - [Domain 2. Area 4 - Score 3] 2a. Has the site initiated networking with the community, including plans to involve PLWHAs?


[2] No → Proceed to Domain 3: Management and Evaluation - [Domain 2. Area 4 - Score 4] 3. Are community meetings underway?


[2] No → Proceed to Domain 3: Management and Evaluation - [Domain 2. Area 4 - Score 5]

3a. Have community leaders been contacted? [1] Yes → Proceed to Question 3b

[2] No → Proceed to Domain 3: Management and Evaluation - [Domain 2. Area 4 - Score 5.5]

3b. Have linkages with the community been established? [1] Yes → Proceed to Question 3c

[2] No → Proceed to Domain 3: Management and Evaluation - [Domain 2. Area 4 - Score 6] Continued...



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3c. Is there a needs assessment underway? [1] Yes → Proceed to Question 3d

[2] No → Proceed to Domain 3: Management and Evaluation - [Domain 2. Area 4 - Score 6.5] 3d. Has the site received formal or informal input from PLWHAs?


[2] No → Proceed to Domain 3: Management and Evaluation - [Domain 2. Area 4 - Score 6.8] 4. Have community networking efforts been established between stakeholders in areas of health administration, government, community-activists, faith-based organizations, etc.?


[2] No → Proceed to Domain 3: Management and Evaluation - [Domain 2. Area 4 - Score 7] 4a. Has a community needs assessment been completed?

[1] Yes → Proceed to Question 4b

[2] No → Proceed to Domain 3: Management and Evaluation - [Domain 2. Area 4 – Score 7.5] 4b. Is there an active involvement of PLWHA groups in the site and the ART program?


[2] No → Proceed to Domain 3: Management and Evaluation - [Domain 2. Area 4 - Score 8] 5. Has community networking been developed into formal referral and/or community collaboration?


[2] No → Proceed to Domain 3: Management and Evaluation - [Domain 2. Area 4 - Score 9]

5a. Does the site have full buy-in of stakeholders, including PLWHAs, traditional healers, government administration, other services organizations, and community leaders?

[1] Yes → Proceed to Domain 3: Management and Evaluation - [Domain 2. Area 3 - Score 10]

[2] No → Proceed to Domain 3: Management and Evaluation - [Domain 2. Area 3 - Score 9.5]

Domain 2.4 Score: _________ Total Services Points: __________ Services Domain Score (Total Services Points / 4) :_________



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Domain 3: Health Information Management, Monitoring, Evaluation, and Quality Area 3.1 Health Management Information Systems (HMIS)

Has site-based medical record system; no or lim-ited ability to track patients longitudinally.

Has basic HMIS to track patients but no specific HIV treatment informa-tion included; some ele-ments of site-based medi-cal record system limited or no capacity for expan-sion to meet ART program needs; limited capacity to track care long-term but inadequate for HIV ser-vices; may have some HIV specific forms.

Has some elements of HMIS including limited capacity to begin monitor-ing of ART patients, but needs to increase capacity for expansion to meet full ART program needs; re-quires improvement in medical record-keeping capacity or management.

Has system to follow patients including some/all specific forms/flow sheets for ART, but may have gaps in tracking patients and medical charting ca-pacity.

Has system in place for tracking patients, medical records, and charting for clinical care and labs in-cluding specific forms/flow sheets or other proc-esses for ART.

1 2 3 4 5 6 7 8 9 10

1. Does the site have any elements of an HMIS in place to track patients? [1] Yes → Proceed to Question 1a

[2] No → Proceed to Area 3.2: ART Program M&E - [Domain 3. Area 1 - Score 1]

1a. Does the site have the ability to track patients longitudinally? [1] Yes → Proceed to Question 2


2. Does the site have an HIV-specific medical record? [1] Yes → Proceed to Question 2a


2a. Does the site have an HIV-specific medical record to monitor ART? [1] Yes → Proceed to Question 3


3. Does the site have some ability to capture elements of a system to begin monitoring of ART patients? [1] Yes → Proceed to Question 3a

[2] No → Proceed to Area 3.2: ART Program M&E - [Domain 3. Area 1 - Score 5] Continued...



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3a. Does the site have most elements in place to monitor patients, though there may be gaps to track over time? [1] Yes → Proceed to Area 3.2: ART Program M&E - [Domain 3. Area 1 - Score 6]


4. Does the site have a system to follow patients including specific forms/flow sheets for ART though some forms may need improvement? [1] Yes → Proceed to Question 4a


4a. Can the site track patients though improvements are needed? [1] Yes → Proceed to Area 3.2: ART Program M&E - [Domain 3. Area 1 - Score 8]


5. Does the site have a system in place for tracking patients, medical records, and charting for clinical care and labs, including specific forms/flow sheets, or other processes for ART?

[1] Yes → Proceed to Area 3.2: ART Program M&E - [Domain 3. Area 1 - Score 10]





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Domain 3: Health Information Management, Monitoring, Evaluation, and Quality (continued) Area 3.2 ART Program Monitoring and Evaluation

Has no procedures or plans for HIV program at neither site level nor M&E for any program.

Has some procedures/ plans for HIV program level M&E for other pro-grams, but inadequate for M&E of ART.

Has HIV-related M&E, some training, or access to other M&E resources, but only draft procedures for M&E of ART in place; done irregularly.

Has some procedures or plans for program level M&E for ART program but plans need improvement or expansion for tracking and analysis.

Program level M&E in-cludes process and outcome measures of HIV care pro-gram including ART.

1 2 3 4 5 6 7 8 9 10

1. Does the site have procedures or plans for the HIV program? [1] Yes → Proceed to Question 1a

[2] No → Proceed to Area 3.3 Quality Management - [Domain 3. Area 2 - Score 1]

1a. Does the site have M&E for any program in place? [1] Yes → Proceed to Question 2


2. Does the site have some M&E procedures for HIV program? [1] Yes → Proceed to Question 3

[2] No → Proceed to Area 3.3 Quality Management - [Domain 3. Area 2 - Score 3-4]

3. Does the site have some M&E related HIV trainings and other resources? [1] Yes → Proceed to Question 4


4. Does the site have more than draft procedures for M&E of ART in place and is M&E done regularly? [1] Yes → Proceed to Question 5


5. Does the site have procedures for program level M&E of ART programs? [1] Yes → Proceed to Question 6

[2] No → Proceed to Area 3.3 Quality Management - [Domain 3. Area 1 - Score 7-8]

6. Does the site have program level M&E that includes process and outcome measures of the HIV care program including ART? [1] Yes → Proceed to Area 3.3 Quality Management - [Domain 3. Area 1 - Score 10]





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Domain 3: Health Information Management, Monitoring, Evaluation, and Quality (continued) Area 3.3 Quality Management

No efforts to assess or strengthen quality of care.

Site has identified a few areas in HIV care and treatment which are chal-lenges, but no clear QM program on how to ad-dress or reevaluate.

Site identifies problems as they arise, but limited abil-ity for routine assessment (ex. chart reviews, review of data etc); some changes have been made but impact was not measured; starting work on QM program.

Established system to rou-tinely assess quality in a lim-ited number of critical areas of HIV care including ART; interventions are planned by a team and some reassess-ment is done; overall quality management program needs strengthening and develop-ment; some elements of pro-gram for assessment exist but needs help.

Established quality manage-ment program including HIV care and ART treatment which includes identification of rou-tine indicators for assessment, team process to develop inter-ventions and plans for assess-ment of impact; can serve as a model or training arena for other sites.

1 2 3 4 5 6 7 8 9 10

1. Has the site undertaken any efforts to assess or strengthen quality of care? [1] Yes → Proceed to Question 2

[2] No → Proceed to Area 4.1 Human Resources Staffing Needs - [Domain 3. Area 3 - Score 1-2] 2. Has the site identified areas in HIV care and treatment which are challenges?


[2] No → Proceed to Area 4.1 Human Resources Staffing Needs - [Domain 3. Area 1 - Score 3] 2a. Is there a Quality Management program in place to address or reevaluate these challenges?


[2] No → Proceed to Area 4.1 Human Resources Staffing Needs - [Domain 3. Area 3 - Score 4] 3. Does the site have the ability for routine assessment of identified problems?


[2] No → Proceed to Area 4.1 Human Resources Staffing Needs - [Domain 3. Area 3 - Score 5] 3a. Has the impact of changes made been measured?


[2] No → Proceed to Area 4.1 Human Resources Staffing Needs [Domain 3. Area 3 - Score 6]

Continued...



20

4. Has the site established systems to routinely assess quality in a limited number of critical areas of HIV care, including ART? [1] Yes → Proceed to Question 5 [2] No → Proceed to Area 4.1 Human Resources Staffing Needs - [Domain 3. Area 3 - Score 7]

5. Are interventions planned by a team and are reassessments done?

[1] Yes → Proceed to Question 6 [2] No → Proceed to Area 4.1 Human Resources Staffing Needs - [Domain 3. Area 3 - Score 8]

6. Does the site have an established quality management program including HIV care and ART treatment which includes identification of routine indicators for assessment, team process to develop interventions and plans for assessment of impact ?

[1] Yes → Proceed to Area 4.1 Human Resources Staffing Needs - [Domain 3. Area 3 - Score 10] [2] No → Proceed to Area 4.1 Human Resources Staffing Needs - [Domain 3. Area 3 - Score 9]

Domain 3.3 Score: _______ Total Health Information Management, Monitoring, Evaluation and Quality Points: _______ Domain Score (Total Health Information Management, Monitoring, Evaluation and Quality Points / 3): _______



21

Domain 4: Human Resource Capacity Area 4.1 Staffing Needs Has multiple vacancies or

positions, including key posts in clinical and sup-port staff and no clear capacity to fill.

Has core clinical and support staff but inadequate capacity to ini-tiate or maintain program or to fill additional vacan-cies; no resources to fill current vacancies or create new posts.

Has core staff and some sup-port staff. Has adequate staff to implement or main-tain current program but not expand ART program. Has begun to clearly outline needs and has plan or pro-posals to fill them.

Still lacking in some clinical or support staffing positions; able to implement but not sustain long-term ART program. Has clearly outlined staff needs and plan or proposal to fill them.

Fully staffed according to model of care and capacity to implement, sustain, and ex-pand ART program and plan to fill future gaps in staffing needs.

1 2 3 4 5 6 7 8 9 10

1. Please select the option that best describes the site’s staffing situation: [1] Site has multiple vacancies, including key positions in clinical and support staff, and no clear capacity to fill in → Proceed to Area 4.2: Training - [Domain 4. Area 1 - Score 1-2] [2] Site has core clinical and support staff → Proceed to Question 2

2. Does the site have the adequate capacity to initiate the ART program or to fill any additional vacancies? [1] Yes → Proceed to Question 3 [2] No → Proceed to Area 4.2: Training and Skills Development - [Domain 4. Area 1 - Score 3-4]

3. Does the site have the adequate capacity to sustain long-term or expand the ART program? [1] Yes → Proceed to Question 4 [2] No → Proceed to Area 4.2: Training and Skills Development - [Domain 4. Area 1 - Score 5-6]

4. Please select the option that best describes the site’s outline for staffing needs: [1] Site has not begun to clearly outline its staffing needs nor has any plans or proposals to fill them → Proceed to Area 4.2: Training -[Domain 4. Area 1 - Score 7] [2] Site has begun clearly outline its staffing needs and has plans or proposals to fill them → Proceed to Area 4.2: Training - [Domain 4. Area 1 – Score 8] [3] Site has clearly outlined staff needs and has a plan or proposal to fill them → Proceed to Question 5

5. Is the site fully staffed according to its model of care, and does it have the capacity to implement, sustain, and expand its ART program? [1] Yes → Proceed to Question 5a [2] No → Proceed to Domain 4 Area 2: Training and Skills Development - [Domain 4. Area 1 - Score 9]

5a. Does the site have the capacity to implement, sustain, and expand its ART program? [1] Yes → Proceed to Domain 4 Area 2: Training and Skills Development - [Domain 4. Area 1 - Score 10] [2] No → Proceed to Domain 4 Area 2: Training and Skills Development - [Domain 4. Area 1 - Score 9.5]




22

Domain 4: Human Resource Capacity (continued)

Area 4.2 Training and Skills Development

Existing staff have little to no training or experience in HIV outpatient care and none have training in ART; no plans for staff training or skills development. Lim-ited or no on-site access to educational and resource materials.

Existing core ART staff have some training or some experience in HIV outpa-tient care but little/no ART training or experi-ence. May have access to training program in other HIV areas but no program for ART. Limited or no on-site access to edu-cational and resource materials.

Minimum key staff at critical levels have been trained in core components of ART but additional train-ing needed for core and sup-port staff. Site staff has some training with ART at all lev-els. Experience with ART is limited to few staff or lim-ited scope. Other staff will require additional training as program expands. Has plan in place for further training staff. On-site resources and educational materials present but inadequate.

Some key staff have some ART training with limited/no experience in practice. Other critical staff have re-ceived limited training. At least one prescribing and evaluating clinician has been trained and rest of other key staff will be trained as program gets un-derway. Has established or planning to access training program in ART. Limited on-site access to educational and resource materials. Some staff w/limited ART experience but not sufficient; needs strengthening.

Has adequately trained staff in most/all positions with experience in HIV primary care and ART including pre-scribing. follow-up, adher-ence support, and counseling. Active training and skills development plan for all staff members. On-site resources and educational materials presently adequate for current needs.

1 2 3 4 5 6 7 8 9 10

1. Please select the option that best describes the site’s staff overall training and experience in HIV outpatient care:

[1] None of the existing staff have training or experience in HIV outpatient care, and none have training in ART → Proceed to Area 4.3: Management, Supervision, and Staff Retention - [Domain 4. Area 2 - Score 1] [2] Few existing staff have training or experience in HIV outpatient care, and none have training in ART → Proceed to Question 1a

1a. Does the site have plans for staff training or skills development?


[2] No → Proceed to Area 4.3: Management, Supervision and Staff Retention - [Domain 4. Area 2 – Score 2]

2. Does the site have access to training in areas other than ART? [1] Yes → Proceed to Question 3

[2] No → Proceed to Area 4.3: Management, Supervision and Staff Retention - [Domain 4. Area 2 – Score 3]

3. Does the site have at least one prescribing and evaluating clinician who has been trained in ART? [1]Yes → Proceed to Question 3a

[2] No → Proceed to Area 4.3: Management, Supervision and Staff Retention - [Domain 4. Area 2 – Score 4] Continued...



23

3a. Does the site plan to train the rest of its key staff in ART as the program gets underway? [1] Yes → Proceed to Question 3b [2] No → Proceed to Area 4.3: Management, Supervision and Staff Retention - [Domain 4. Area 2 – Score 5]

3b. Has the site established or planned to access a training program in ART? [1] Yes → Proceed to Question 4 [2] No → Proceed to Area 4.3: Management, Supervision and Staff Retention - [Domain 4. Area 2 – Score 6]

4. Have the site’s minimum key staff at critical levels been fully trained in prescribing, follow-up, and adherence with ARVs in treatment? [1] Yes → Proceed to Question 4a [2] No → Proceed to Area 4.3: Management, Supervision and Staff Retention - [Domain 4. Area 2 – Score 7]

4a. Have site’s staff had some training with ART at all levels? [1] Yes → Proceed to Question 4b [2] [2] No → Proceed to Area 4.3: Management, Supervision and Staff Retention - [Domain 4. Area 2 – Score 7.5]

4b. Are all staff experienced with ART? [1] Yes → Proceed to Question 4c [2] No, experience with ART is limited to a few staff, and other staff will require additional training as the program expands? → Proceed to Area 4.3: Management, Supervision and Staff Retention - [Domain 4. Area 2 – Score 8]

4c. Does the site have a plan in place for further training staff? [1] Yes → Proceed to Question 4d [2] No → Proceed to Area 4.3: Management, Supervision and Staff Retention - [Domain 4. Area 2 – Score 8.2]

4d. Is the site developing on-site resources and educational materials? [1] Yes → Proceed to Question 5 [2] [2] No → Proceed to Area 4.3: Management, Supervision and Staff Retention - [Domain 4. Area 2 – Score 8.5]

5. Has the site adequately trained staff in most/all positions with experience in HIV primary care and ART, including prescribing, follow-up, adherence support, and counseling?

[1] Yes → Proceed to Question 5a [2] [2] No → Proceed to Area 4.3: Management, Supervision and Staff Retention - [Domain 4. Area 2 – Score 8.8]

5a. Does the site have an active training and skills development plan for all staff members? [1] Yes → Proceed to Question 5b [2] No → Proceed to Area 4.3: Management, Supervision and Staff Retention - [Domain 4. Area 2 – Score 9]

5b. Does the site have on-site resources and educational materials? [1] Yes → Proceed to Area 4.3: Management, Supervision and Staff Retention - [Domain 4. Area 2 – Score 10] [2] No → Proceed to Area 4.3: Management, Supervision and Staff Retention - [Domain 4. Area 2 – Score 9.5]

Domain 4.2 Score: ______



24

Domain 4: Human Resource Capacity (continued) Area 4.3 Management, Supervision, and Staff Retention

Has no plan for staffing needs, supervision, management, or retention; will require extensive support and strengthening.

Developing staffing plan but needs additional assistance in multiple areas in expansion of system for hiring, supervi-sion, and management. As-sistance needed in developing.

Has reactive supervision and management system with informal plan for proactive hiring process, staff supervi-sion, and/or management system.

Has most of staffing. management, and supervision plan in place and operational; may require additional proactive management.

Implementing proactive supervision and management system including identified staffing responsibilities and task assignments, on-going retention plan, and knowledge of staffing needs.

1 2 3 4 5 6 7 8 9 10

1. Please select the option that best describes the site’s plan for staffing needs: [1] Has no plan for staffing needs, supervision, management or retention. Will require extensive planning → Proceed to Domain 5: Lab Capacity - [Domain 4. Area 3 – Score 1-2] [2] Site is developing a staffing plan, but needs additional expansion of system for hiring, supervision, and management→ Proceed to Question 2

2. Does the site have a supervision and management system with informal plan for hiring, staff supervision, and/or management system in place? [1] Yes → Proceed to Question 3 [2] No → Proceed to Domain 5: Lab Capacity- [Domain 4. Area 3 – Score 3-4]

3. Does the site have most of its staffing, management and supervision plan in place? [1] Yes → Proceed to Question 3a [2] No → Proceed to Domain 5: Lab Capacity- [Domain 4. Area 3 – Score 5-6]

3a. Does the site require additional proactive management? [1] Yes → Proceed to Domain 5: Lab Capacity- [Domain 4. Area 3 – Score 7-8] [2] No → Proceed to Question 4

4. Has the site implemented a supervision and management system, including identification of staffing responsibilities and task assignments, ongoing retention plans, and knowledge of staffing needs? [1] Yes → Proceed to Domain 5: Lab Capacity- [Domain 4. Area 3 – Score 10] [2] No → Proceed to Domain 5: Lab Capacity- [Domain 4. Area 3 – Score 9] Domain 4.3 Score: _______ Total Human Resource Points: ________ Human Resource Domain Score (Total Human Resource Points / 3): ________



25

Domain 5: Lab Capacity Area 5.1 Laboratory Procedures Capability

Has limited or no access to required labs as defined in Minimum WHO or na-tional protocols.

Has access to required labs as defined in na-tional protocols but not reliable.

Has reliable access to required labs for screening and moni-toring as defined in WHO/national protocols. Has no or unreliable access to timely labs for evaluation of toxici-ties (liver function tests, Hb) or treatment failure (CD4 count).

Has more extensive lab capa-bility to reliably conduct all required labs procedures as dictated by site protocol for screening. initiating, moni-toring and toxicity manage-ment either on-site or through referral, however turnaround time and result management needs improve-ment.

Has full spectrum of tests as required by site ARV proto-col as well as CD4 count; reliable and timely results available. Can serve as referral center for viral load and/or resistance testing

1 2 3 4 5 6 7 8 9 10

1. Does the site have access to required labs as defined in the minimum WHO protocols? [1] Yes → Proceed to Question 2

[2] No, access is nonexistent→ Proceed to Area 5.2: Quality Standards- [Domain 5. Area 1 – Score 1]

[3] Limited access to WHO protocols→ Proceed to Area 5.2: Quality Standards- [Domain 5. Area 1 – Score 2] 2. Is the access to the minimum labs reliable? [1] Yes → Proceed to Question 3

[2] No → Proceed to Area 5.2: Quality Standards - [Domain 5. Area 1 – Score 3-4] 3. Does the site have access to labs for screening and monitoring as defined in national or site protocols? [1] Yes → Proceed to Question 3a

[2] No → Proceed to Area 5.2: Quality Standards - [Domain 5. Area 1 – Score 5] 3a. Does the site have access to labs for evaluation of toxicities (liver function test, amylase) or treatment failure (CD4 count)? [1] Yes → Proceed to Question 4

[2] No → Proceed to Area 5.2: Quality Standards - [Domain 5. Area 1 – Score 6]

Continued...



26

4. Does the site have an extensive lab capacity to reliably conduct all required lab procedures as directed by site protocol for screening, initiating, monitoring and toxicity management, either on-site or through referral? [1] Yes → Proceed to Question 4a

[2] No → Proceed to Area 5.2: Quality Standards - [Domain 5. Area 1 – Score 7] 4a. Is the lab able to return lab results within specified turn around times according to site protocol? [1] Yes → Proceed to Question 5

[2] No → Proceed to Area 5.2: Quality Standards - [Domain 5. Area 1 – Score 8] 5. Does the lab have the full spectrum of tests, as required by the site ARV protocol, as well as CD4 count and can it also serve as a resource center? [1] Yes → Proceed to Area 5.2: Quality Standards - [Domain 5. Area 1 – Score 10]

[2] No → Proceed to Area 5.2: Quality Standards - [Domain 5. Area 1 – Score 9] Domain 5.1 Score: ________



27

Domain 5: Lab Capacity (continued) Area 5.2 Quality Standards

Has no lab quality standards; no program or budget for equipment maintenance; frequent in-terruptions in availability of lab supplies.

Has limited lab quality standards in place but unre-liable equipment mainte-nance program and quality control process; no supply protocol with frequent ser-vice interruptions.

Has somewhat reliable equipment with some functioning maintenance program; lab has some quality standards but com-pliance is irregular; supply protocol needs strengthen-ing.

Has relatively reliable equipment with back-up plan and equipment main-tenance program in place; lab does some internal and external quality control; may have occasional breaks in service or supply; reli-able supply protocol.

Has internal and external quality control program, reli-able equipment maintenance program, and continuous availability of reagents and other lab supplies; breaks in service and supply uncom-mon.

1 2 3 4 5 6 7 8 9 10

1. Does the lab have any quality standards? [1] Yes → Proceed to Question 2

[2] No → Proceed to Area 6.1: Drug Management - [Domain 5. Area 2 – Score 1] 2. Does the lab have a program or budget for equipment? [1] Yes → Proceed to Question 3

[2] No → Proceed to Area 6.1: Drug Management - [Domain 5. Area 2 – Score 2] 3. Does the lab have a quality control process in place? [1] Yes → Proceed to Question 3a

[2] No → Proceed to Area 6.1: Drug Management - [Domain 5. Area 2 – Score 3-4] 3a. Does the lab have reliable equipment with a functioning maintenance plan? [1] Yes → Proceed to Question 4

[2] No → Proceed to Area 6.1: Drug Management - [Domain 5. Area 2 – Score5- 6] 4. Does the lab have a back-up plan and equipment maintenance program in place? [1] Yes → Proceed to Question 4a

[2] No → Proceed to Area 6.1: Drug Management - [Domain 5. Area 2 – Score 7]

Continued...



28

4a. Does the lab have some internal and external quality controls? [1] Yes → Proceed to Question 5

[2] No → Proceed to Area 5.2: Quality Standards - [Domain 5. Area 2 – Score 8] 5. Does the lab have continuous availability of reagents and other lab supplies with little to no breaks in service or supply? [1] Yes → Proceed to Area 6.1: Drug Management - [Domain 5. Area 2 – Score 10]

[2] No → Proceed to Area 6.1: Drug Management - [Domain 5. Area 2 – Score 9] Domain 5.2 Score: _______ Total Lab Points: ________ Lab Domain Score (Total Lab Points / 2): ________



29

Domain 6: Drug Management and Procurement Area 6.1 Drug Management

Has extremely limited sup-ply chain in place; stock outs have occurred in ARV supply (if already in use) and other essential drugs; needs improvement in multi-ple areas including procure-ment and management of ARVs and creating a QA process7for product avail-ability.

Has somewhat reliable sup-ply chain in place though stock outs occur but not com-mon; needs to improve in more than area and needs significant adaptation to ac-commodate specific require-ments of ARVs; very limited QA process for product availability.

Has supply chain in place but security of supply still a concern.; may needs adapta-tion to accommodate spe-cific requirements of ARVs; has quality assurance process for product availability but needs strengthening.

Has secure supply chain8 no stock outs, but may need technical assistance in in-ventory management proce-dures for ARVs; has quality assurance process for prod-uct availability.

Has secure supply chain from supplier to service site in-cluding appropriate and se-cure local storage and dis-pensing and QA system for monitoring product availabil-ity to prevent stock outs of ARVs; can serve as resource/training site.

1 2 3 4 5 6 7 8 9 10 7. QA process for supply chain includes a functioning logistics management information system and adequate logistics supervision. 8. Secure supply chain implies safe transport and storage, clear source of resupply of drugs, established inventory control and resupply system, and capacity and plans for drug forecasting

1. Does the site have a supply chain? [1] Yes → Proceed to Question 2

[2] No → Proceed to Area 6.2: Pharmacy Management - [Domain 6. Area 1 – Score 1-2] 2. Does the site have a reliable system for procurement and management of ARVs? [1] Yes → Proceed to Question 3

[2] No → Proceed to Area 6.2: Pharmacy Management - [Domain 6. Area 1 – Score 3] 3. Does the site have a quality assurance process for product availability? [1] Yes → Proceed to Question 3a

[2] No → Proceed to Area 6.2: Pharmacy Management - [Domain 6. Area 1 – Score 4] 3a. Does the site have a supply chain in place that accommodates the specific requirements of ARVs? [1] Yes → Proceed to Question 4

[2] No → Proceed to Area 6.2: Pharmacy Management - [Domain 6. Area 1 – Score 5-6]

Continued...



30

4. Does the site have inventory management procedures? [1] Yes → Proceed to Question 4a

[2] No → Proceed to Area 6.2: Pharmacy Management - [Domain 6. Area 1 – Score 7] 4a. Does the site have a quality assurance process for product availability? [1] Yes → Proceed to Question 5

[2] No → Proceed to Area 6.2: Pharmacy Management - [Domain 6. Area 1 – Score 8] 5. Does the site have the ability to serve as a resource/training site? [1] Yes → Proceed to Area 6.2: Pharmacy Management - [Domain 6. Area 1 – Score 10]

[2] No → Proceed to Area 5.2: Pharmacy Management - [Domain 6. Area 1 – Score 9] Domain 6.1 Score: ________



31

Domain 6: Drug Management and Procurement (continued) Area

6.2 Pharmacy Management

Has no established procedures for ARVs; does not follow inventory man-agement procedures for other essential drugs.

Has limited management pro-cedures for ARVs and limited, unreliable inventory manage-ment procedures for other es-sential drugs; procedures for other HIV-specific commoditi-es9 are present but either unre-liable or incomplete.

Has limited inventory man-agement procedures for ARVs in place but has established inventory management proce-dures for other essential drugs and at least some HIV-specific commodities; signifi-cant gaps exist in procedures and practice.

Has implemented inventory management procedures for ARVs but some gaps in either procedures or practice; has established inventory manage-ment procedures for other es-sential drugs including HIV- specific commodities, if avail-able, but limited gaps.

Has established ARV inventory management tools and procedures including forecasting/ calculating resupply orders; routine stock status report-ing, dispensing, and ordering emergency supplies. Has same for other essential drugs.

1 2 3 4 5 6 7 8 9 10

9 HIV-specific commodities include products such as HIV tests, fluconazole, and nevirapine for PMTCT which may be distributed through separate supply chains.

1. Does the site follow inventory management procedures for essential drugs? [1] Yes → Proceed to Question 2

[2] No → Proceed to Determining a Site’s Program Readiness Stage - [Domain 6. Area 2 – Score 1] 2. Does the site have established management procedures for dispensing ARVs? [1] Yes → Proceed to Question 3

[2] No → Proceed to Determining a Site’s Program Readiness Stage - [Domain 6. Area 2 – Score 2] 3. Does the site have reliable procedures for dispensing other HIV-specific commodities? [1] Yes → Proceed to Question 4

[2] No → Proceed to Determining a Site’s Program Readiness Stage - [Domain 6. Area 2 – Score 3-4] 4. Does the site have significant gaps in procedures and practice for dispensing ARVs and other essential drugs? [1] Yes → Proceed to Determining a Site’s Program Readiness Stage - [Domain 6. Area 2 – Score 5-6]

[2] No → Proceed to Question 5 5. Does the site have limited gaps in either procedures or practice for dispensing ARV inventory management? [1] Yes → Proceed to Determining a Site’s Program Readiness Stage - [Domain 6. Area 2 – Score 7]

[2] No → Proceed to Question 5a

Continued...



32

5a. Does the site have limited gaps in established inventory management procedures for other essential drugs including HIV- specific commodities? [1] Yes → Proceed to Determining a Site’s Program Readiness Stage - [Domain 6. Area 2 – Score 8]

[2] No → Proceed to Question 6 6. Does the site have established inventory management tools and procedures including forecasting/calculating resupply orders; routine stock status reporting, dispensing, and ordering emergency supplies for ARVs and other essential drugs? [1] Yes → Proceed to Determining a Site’s Program Readiness Stage - [Domain 6. Area 1 – Score 10]

[2] No → Proceed to Determining a Site’s Program Readiness Stage - [Domain 6. Area 1 – Score 9] Domain 6.2 Score: ________ Total Drug Management Points: ________ Drug Management Domain Score (Total Drug Management Points / 2): _________



33

Determining a Site’s Program Readiness Stage

Scoring Summary What Does the Score Mean?

Bring forward the score from each domain and add them together to get an Overall Program To-tal. Your program stage is based on both the domain score and the lowest score in an area. This qualitative tool can indicate, generally, where an

organization falls along the Readiness Scale (1 to 10) to initiate an ART program as well as capacity for existing ART sites. This tool presents a general assessment with-out emphasizing the importance of one domain over another. An overall score that places a site at Stage 4 or 5 indicates a program is the most prepared to initiate ART or is strong in the delivery of ART if already un-derway, and a score that places a site at Stage 1 indi-cates that the program needs significant work and plan-ning to start and manage an ART program.

It is recommended that a site have at least a score of “5”or “6” in each domain to begin ART. If any area scores < 5, the maximum a site can be is a stage 3 and technical assistance should be provided to bring this area up to at least a 3 ideally prior to initiation of ART program if not already underway, or prioritized for a site which is already started.

Each stage is described below with specific activities and recommendations that will move an organization closer to Stage 5—Expansion and Resource Site.

Domain Score Within Domain Leadership and Program Model __________ ___________ Services and Clinical Care __________ ___________ Health Information Management, Monitoring, Evaluation, and Quality __________ ___________ Human Resource Capacity __________ ___________ Lab Capacity __________ ___________ Drug Management and Procurement __________ ___________

Overall Program Total __________

Scoring Range: Overall Program Total Stage 1–16 1 Stage Score ___________ 17–26 2 25-36 3 37-48 4 49–60 5

Stage 1:

Beginning Site

Stage 2:

Emerging Site

Stage 3:

Maturing Site

Stage 4:

Consolidation Site

Stage 5:

Expansion and Resource Site



34

Stage 1: Beginning Site These sites are doing limited to no HIV outpatient or inpatient care or they may have started providing ARVs on a limited basis. There may be no leader willing to champion the ART program. If ART is being offered this site may have started providing ARVs on a limited basis with a minimum of leadership for ART service provision.

Sites at this stage need training and education to expand capacity and knowledge, move to Stage 2, and identify a leader. Other assistance is needed to begin several components including program design and planning, assessment of current capacity, and projecting for staff and other resources required as ARVs are further introduced. These sites might be considered for follow-up of patients on ARVs as a first step, with capacity to continue initiation of ARVs in the future.

Stage 1:

Beginning Site

Some areas where additional resources are needed include—

Leadership Identify or recruit a leader and implement training to develop a

vision and a will to embark on an ARV program. Design a program, including identification of space and model of

care. Create links with other sites in-country or the region already pro-

viding ARV treatment, if possible, for local technical assistance and learning about successful models.

Protocols and Management Begin to identify and adopt protocols for basic HIV care and OI

prophylaxis and treatment. Receive technical assistance in development or improvement in

HMIS system including patient tracking, medical records, and charting.

Access assistance in developing program indicators and appropri-ate system for M&E of HIV care, which can be expanded in the future for the ART program.

Services Identify critical areas that need immediate expansion to reach the

next level (i.e., VCT, OI treatment, etc.). Coordinate programs with referral system to ensure follow-up and

continuum of care.

Human Resource Capacity

Identify resources/mechanisms to recruit new staff or change task assignments to reflect personnel types that are available.

Expand and/or train staff resources in one or more areas to meet at least minimum essential staff for prescribing, follow-up, and adher-ence.

Lab Receive assistance in developing reliable access to lab services,

whether on-site or referral, training, supplies, and expansion, as required by minimum standards from site protocols.

Drug Management and Procurement Improve policies and procedures for supply chain management and

address identified gaps or areas for improvement including training, systems, and pharmacy staff.

Secure a regular supply of essential drugs for HIV care including OI management and prevention.

Start to identify and access funding sources after leadership is identi-fied and the site model of care has started to be developed.

Receive assistance in development or expansion of logistics QA.



35

Stage 2: Emerging Site These sites have a leader with some vision and interest in ARVs, but with HIV and AIDS capacity and experience limited perhaps to only HIV primary care and possibly PMTCT. Likewise, these sites may have started providing ARVs but need assistance in multiple areas. They are making efforts to expand services through linkages and staff training.

Sites at this stage need assistance in program design and implementation in a number of areas. These are ideal sites to replicate models proven to be effec-tive in similar settings. These sites might be considered for follow-up of patients on ARVs as a first step with capacity to initiate ART in the future.

Stage 2:

Emerging Site

Sites may need— Leadership

Design of program, including defining vision and goals, manage-ment plans, identification of space, definition of model, staffing plan, and site spectrum of care.

Develop linkages with other in-country or regional sites already providing ART, if possible.

Protocols and Management Begin to identify and adopt protocols for eligibility, regimens, ini-

tiation, clinical and lab monitoring and follow-up, adherence, man-agement of side effects, treatment interruption, and treatment fail-ure.

Request technical assistance in development or improvement in HMIS system including patient tracking, medical records, and charting.

Seek assistance in developing program indicators and appropriate system for M&E of HIV care including ARV treatment that reflects the site’s resources and capacity.

Services Begin to identify and adopt operational procedures for HIV care,

ARV use, and selection of ARV drug products. Coordinate programs with referral system to ensure follow-up and

continuum of care. Identify critical areas need immediate expansion to reach the next

level (i.e., VCT, OI treatment, etc.).


Expand and/or train staff resources in one or more areas to meet at least minimum essential staff for prescribing, follow-up, and adherence.

Lab Develop experience in maintaining reliable access to lab services,

whether on-site or referral, training, supplies, and expansion, as re-quired by adopted site protocols.

Drug Management and Procurement Obtain assistance with improving policies and procedures for supply

chain management and addressing identified gaps or areas for improve-ment, including training, systems, and pharmacy staff.

Seek assistance in starting to identify and access funding sources for ARVs.

Obtain technical expertise in securing essential drugs for HIV care in-cluding OI management and prevention.

Request assistance in developing or expanding QI for monitoring ART and other product availability.



36

Stage 3: Maturing Site Sites with this score have a vision and a leader committed to the introduction of ART and are beginning to prepare for introducing ART. They have demonstrated initiative or quality performance in some areas of HIV care (OI, PMTCT), but are missing some com-

ponents. These sites still require more capacity building and funding, but they have potential to start at a small scale ARV soon or at a fuller scale if re-sources are available to address needs. Resources and capacity will need strengthening simultaneously or prior to ART start even to complete first 6-12 months of treatment or to achieve even modest year 1 goals. Sites already underway will need technical assistance to areas of challenge (score 4 or below).

Stage 3: Maturing Site

Longer-term strengthening may be needed in 5-6 key areas and may in-clude—

Leadership Better defined goals and vision which are incorporated into day-to-

day activities and future plans. Seek assistance with design of program, including definition of

model, staffing plan, and site spectrum of care.

Protocols and Management Identify and adopt protocols for eligibility, regimens, initiation,

clinical and lab monitoring and follow-up, adherence, management of side effects, treatment interruption, and treatment failure.

Seek technical assistance in development or improvement in MIS system including patient tracking, medical records, and charting.

Develop program indicators and appropriate system for M&E of HIV care including ARV treatment that reflects the site’s resources and capacity.

Services Seek assistance with identification of space. Expand scope of services to meet requirements as defined by cho-

sen model of care and linkages to other organizations to meet other needs.


Expand and/or train staff in one or more areas to meet at least mini-mum essential staff for prescribing, follow-up, and adherence.

Lab Request expertise in maintaining reliable access to lab services,

training and supplies, and expansion, as required by adopted site protocols.

Drug Management and Procurement Improve policies and procedures for supply chain management and

addressing identified gaps or areas for improvement. Identify and secure resources and ART procurement sources. Seek assistance in procuring ART and ensuring access to other essential

drugs for HIV care. Develop or expand QI for monitoring ART and other product avail-

ability.



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Stage 4: Consolidation Site Sites in this stage are nearly or have already started ART but may still need assistance in one or more critical areas or a number of supportive areas. Efforts are aimed at improving/ensuring rational and safe use of ART and associated services while starting or continuing introduction of ART. These sites can also begin to plan for expansion to serve larger numbers of patients or support

peripheral sites. While some sites will aim to progress beyond this point to Stage 5, for many sites remaining at Stage 4 will be appropriate as they have a very valuable role within the context of a national program. Some sites can work to move to Stage 5 if access to a Stage 5 facility for consultation and referral is possible.

Stage 4: Consolidation

Site

Sites may need—

Leadership Better defined goals and vision and be more incorporated into day-to-

day activities and future plans. Seek assistance in estimating needs, problem solving, and planning. Search for technical expertise in long-term planning.

Protocols and Management Seek assistance in developing or formalizing written protocols for

eligibility, regimens, initiation, clinical and lab monitoring and fol-low-up, adherence, management of side effects, treatment in-terruption, and treatment failure.

Establish appropriate operational procedures that reflect site resources and capacity.

Develop indicators and appropriate system for M&E that reflect the site's resources and capacity.

Services May need a formal plan for initiation or expansion of ARVs at the

site. Identify confidential space or other areas, as needed, to reflect in-

creased services. Expand scope or capacity of limited number of services through addi-

tional resources, hiring or cross-training, or creation of linkages with other organizations to fill gaps.


Further training for additional staff may be required; plans for addi-tional hiring, or assistance with linkages to other organizations to sup-ply other needed services needed.

Lab Maintain reliable access to lab services, training, and supplies. Seek assistance in identifying additional monitoring as determined by

protocol (ex., CD4 cell counts).

Drug Management and Procurement Address gaps in practices or procedures relating to establishing a se-

cure, reliable supply chain for ARV drugs, HIV specialty commodities, and other essential drugs.

Identify and secure additional resources to buffer against uncertainties in funding for ARV procurement, and to ensure funding for more than year one.

Implement procedures to enhance procurement of quality ARVs and additional essential drugs for HIV care including OI prevention and treatment.

Enhance QI procedures and practices for monitoring ARV and other product availability to ensure a reliable, secure supply of commodities.



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Stage 5: Expansion and Resource Site These sites are already operational and work well, but they may require assistance in maintaining or expanding current efforts (scale-up and out), especially if commodity supply relies on a larger system beyond the site's control. They may also serve as training sites for other organizations in other stages, or may serve as models, or may provide technical assistance for replication at other sites locally

or elsewhere (scale-out). Sites at this stage may need help to improve in some of the critical areas, but most efforts will be towards maintaining or expanding capacity, on-going education (patients and providers), training of site staff to serve as resources for other sites and disseminate lessons learned, and work to identify additional resources for expansion. In addition, efforts need to be made to evaluate programs and protocols through continuous quality improvement (CQI). Finally, training and assistance in long-term planning for programs may be needed.

Stage 5: Expansion and Resource Site

Specifically, sites may need to:

Leadership and Model Support and training for leading program maintenance and expansion Ongoing assistance for estimating future needs and long term plan-

ning. Ongoing support to refine model based on feedback from site and

advances in the field of ART and HIV care Support to review and update protocols to reflect evaluation and ad-

vances in field of ART Services Assistance in identifying additional space required for program ex-

pansion and to meet previously unidentified needs. Expand scope or capacity of services through additional resources,

hiring or cross-training, or creation of linkages with other organiza-tions to fill gaps or meet growing demands

Continue to work with community to increase participation and sup-port of program and its patients, including addressing stigma, com-munity education and mobilization.

Consider community needs assessment as expansion is planned Management and Evaluation Further refine and expand evaluation program and utilize data col-

lected to improve current program and planned expansion Continue to strengthen MIS system to accommodate growing de-

mands and/or improve efficiency and effectiveness

Human Resource Capacity Require ongoing training for staff in areas of need identified through

monitoring and evaluation to ensure continuous quality improvement Continue to fill human resource gaps; obtain resources and hire for pro-

gram expansion Increase staff support services and monitor and address job fatigue and

stress Lab Continue to seek assistance in maintaining reliable access to lab

services, training, and supplies. Continue to identify additional monitoring as determined by expan-

sion plans, budget and available and appropriate technology (e.g., viral load testing, resistance testing).

Develop alternative sources of lab reagents and supplies if the site is reliant on a national system and the system is not able to provide un-interrupted lab supplies

Drug Management and Procurement Ensure alternate funding sources to buffer against uncertainties in sup-

ply of ARV drugs and other key essential drugs for HIV care, includ-ing HIV testing and OI prevention and treatment



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John Snow, Inc. 44 Farnsworth St.

Boston, MA, 02210 USA

Phone: 617-482-9485 Fax: 617-482-0617

www.jsi.com

Email: HIV and [email protected]

Documents

Tool to Assess Site Readiness for Initiating