Assessment of the Quality of HIV/AIDS Services in Malawi

Transcription

1 TECHNICAL REPORT Assessment of the Quality of HIV/AIDS Services in Malawi JUNE 2011 This report was prepared by Family Health International (FHI) and University Research Co., LLC (URC) for review by the United States Agency for International Development (USAID). It was authored by Ilka Rondinelli, Bruno Bouchet, and Nilu Rimal of FHI. The HIV quality assessment in Malawi was funded by the U.S. President s Emergency Plan for AIDS Relief (PEPFAR) and carried out under the USAID Health Care Improvement Project, which is made possible by the generous support of the American people through USAID.

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3 TECHNICAL REPORT Assessment of the Quality of HIV/AIDS Services in Malawi JUNE 2011 Ilka Rondinelli Bruno Bouchet Nilu Rimal DISCLAIMER The views expressed in this publication do not necessarily reflect the views of the United States Agency for International Development (USAID) or the United States Government.

4 Acknowledgements: This report was prepared by Family Health International (FHI) for review by the United States Agency for International Development (USAID) in collaboration with University Research Co., LLC (URC). The assessment was led in Malawi by Ms. Ilka Rondinelli. Dr. Bruno Bouchet, director of FHI s Health Systems Strengthening unit, reviewed and provided inputs to finalize the assessment tools and technical report, and Ms. Nilu Rimal, senior technical officer for health management information systems, conducted the data analysis. The FHI assessment team would like to thank URC for supporting this quality assessment through the USAID Health Care Improvement Project, which is made possible by the support of the American people through USAID. In particular, we are grateful to Dr. Elizabeth Turesson, senior technical advisor for HIV/AIDS and laboratory, for her technical support in reviewing assessment tools and designing the survey. We are also indebted to the Malawi Ministry of Health and the health district directors for helping us identify assessment sites, facilitating field work logistics, and providing overall support throughout the quality assessment process. We would like to extend special thanks to FHI Malawi staff Mr. Nick Ford, country director, and Mr. McPherson Gondwe, senior technical officer, for their invaluable technical assistance on sampling and issues related to assessment design and implementation. We would also like to thank the data collectors, all staff of the Ministry of Health: Eveles Banda, Nurse; Moses Mhango, Clinical Technician; Olive Makuwira, Nurse; Francis Mvula, Clinical Technician; Georga Mphara, Clinical Technician; and Maggie Zgambo, Nurse. Without their efforts, the assessment would not have been possible. Finally, a very special thanks to the health facility directors and providers who took precious time out of their busy days to speak with us about their experiences with the HIV/AIDS services of interest. We hope that their kindness will be sufficiently repaid through improvements both in services and in systems of support at the sites. The USAID Health Care Improvement Project is implemented by URC under the terms of Contract Number GHN-I URC s subcontractors for the HCI Project include EnCompass LLC, Family Health International, Health Research Inc., Initiatives Inc., Institute for Healthcare Improvement, and Johns Hopkins University Center for Communication Programs. For more information on the work of the USAID Health Care Improvement Project, please visit or contact hci-info@urc-chs.com. Recommended citation: Rondinelli I, Bouchet B, and Rimal N Assessment of the Quality of HIV/AIDS Services in Malawi. Technical Report. Published by the USAID Health Care Improvement Project. Bethesda, MD: University Research Co., LLC (URC).

5 TABLE OF CONTENTS LIST OF TABLES AND FIGURES... i ABBREVIATIONS... ii I. BACKGROUND... 1 A. Objectives of the Assessment... 1 II. QUALITY ASSESSMENT DESIGN AND METHODS... 2 A. Site Selection and Sample Size... 2 B. Data Collection... 3 C. Data Entry and Analysis... 4 D. Patient Information System and Data Quality... 4 III. FINDINGS... 4 A. HIV/AIDS Continuum of Care Services... 4 B. Laboratory Services... 7 C. Pre-ART and ART Services... 8 D. PMTCT Services IV. CHALLENGES AND RECOMMENDATIONS A. Issues with Cross-cutting Functions of the Health System for HIV/AIDS Services B. Recommendations to Address Service Quality V. REFERENCES ANNEX: DATA COLLECTION TOOLS Quality Assessment Tool: Continuum of Care Quality Assessment Tool: PMTCT Services Quality Assessment Tool: HIV Laboratory Services Quality Assessment Tool: ART Services LIST OF TABLES AND FIGURES Figure 1: Profile of health facilities assessed... 3 Figure 2: Health facilities assessed by type of setting... 3 Figure 3: Counseling services by cadre of provider... 4 Figure 4: Referral for ART eligibility... 5 Figure 5: Availability of support groups for HIV patients... 5 Figure 6: Availability of PCR for early infant diagnosis... 6 Figure 7: Availability of TB services for HIV patients in assessed sites (n=20)... 6 Figure 8: Compliance with selected lab quality standards... 8 Figure 9: Services recorded at pre-art initial visit... 9 Figure 10: PMTCT services recorded Table 1: Districts represented and number of facilities visited... 3 Table 2: Districts and facilities visited, Malawi HIV/AIDS Services Quality Assessment i

6 ABBREVIATIONS AIDS Acquired immune deficiency syndrome ANC Antenatal care ART Antiretroviral therapy ARV Antiretroviral AZT Zidovudine CBO Community-based organization CH Central hospital CHBC Community home-based care CTP Cotrimoxazole prophylaxis DH District hospital FBO Faith-based organization FHI Family Health International FP Family planning GFATM Global Fund to Fight Aids, Tuberculosis and Malaria HCI USAID Health Care Improvement Project HCT HIV counseling and testing HIV Human immunodeficiency virus HSS Health systems strengthening MOH Ministry of Health MSDS Material Safety Data Sheet NGO n-governmental organization NVP Nevirapine PCR Polymerase Chain Reaction PICT Provider-initiated testing and counseling PLHA Persons living with HIV and AIDS PMTCT Prevention of mother-to-child transmission QA Quality assurance QI Quality improvement sd-nvp Single dose Nevirapine STO Senior Technical Officer TB Tuberculosis UN United Nations UNAIDS Joint United Nations Program on HIV/AIDS UNDP United Nations Development Program UNGASS United Nations General Assembly Special Session URC University Research Co. LLC USG United States Government VCT Voluntary Counseling and Testing WHO World Health Organization ii Malawi HIV/AIDS Services Quality Assessment

7 EXECUTIVE SUMMARY Introduction According to the United Nations (UNGASS Country Progress Report ), Malawi continues to make significant progress in the national response to HIV/AIDS, particularly in the areas of prevention; treatment, care, and support; and impact mitigation. The national HIV prevalence rate has stabilized at 12%, signaling that more work still needs to be done on the prevention front. Malawi has three regions: rth, Central, and South. They have a population distribution of 13%, 42%, and 45%, respectively. The 2007 sentinel survey results show that, over the years, HIV prevalence has consistently been higher in the Southern Region (20.5%) followed by the Central Region (10.7%) and then the rthern Region (10.2%). Although it is believed that the delivery of care has had important positive outcomes in the country s HIV/AIDS response as health sector reforms and supportive national policies, guidelines, and standard operating procedures have been implemented the quality of services had not been formally assessed before Family Health International (FHI), in response to a task order issued by University Research Co., LLC (URC) under the USAID Health Care Improvement Project (HCI) and, in coordination with the Ministry of Health (MOH) of Malawi, conducted an assessment of the quality of selected HIV/AIDS services in 20 health facilities in the Southern Region in April and May Methods The assessment applied a descriptive cross-sectional survey methodology, with qualitative and quantitative data collection by a team of trained local data collectors. Work was coordinated by an FHI senior technical officer for quality improvement/health systems strengthening and FHI/Malawi. Data collection tools were adapted from HCI tools used in earlier assessments in Uganda and Cote d Ivoire to gather information on antiretroviral therapy (ART), the prevention of mother-to-child transmission (PMTCT), the HIV/AIDS continuum of care, and laboratory services. Of the 20 facilities assessed, 80% were in the public sector, including the military services, and 20% were run by faith-based organizations. Eighty-five percent were in rural areas and 15% in urban areas. At each facility, data collectors interviewed facility managers and service providers and reviewed medical records for three patient cohorts: pre-art, ART, and PMTCT. Findings Profile of the Facilities All facilities were open five days a week, with some services available on weekends. Facilities provided comprehensive HIV/AIDS services: HIV counseling and testing (HCT), provider-initiated testing and counseling (PITC), ART, PMTCT, family planning (FP), TB, and pharmacy services. All sites reported having community-based care (CBC), but only 85% were formally linked with community agents that provided basic nursing care, palliative care, infection prevention guidance, and basic drugs and supplies. Assistance for AIDS patients was provided by family members and community volunteers trained and supported by the facilities staff. The referral system to health facilities was very poor, reportedly due to a lack of transportation. All assessed facilities had adopted rapid HIV testing and had integrated HCT with antenatal care. Eighty-five percent of the facilities provided limited support to community-based organizations (CBOs) serving vulnerable children and youth, but communication and systematic support were lacking due to a shortage of staff and limited resources for transportation (many donors supporting CBOs were phasing out). CBOs and volunteers were trained by the district s Social Welfare Department. Visited CBOs were providing basic services: education and one meal a day. Malawi HIV/AIDS Services Quality Assessment iii

8 Only 20% of the facilities had a system to follow up on HIV-positive women who had delivered at home. HIV testing kits were always available in only 35% of the health facilities. All health facilities had adopted World Health Organization (WHO) staging for ART eligibility. Fifty percent offered CD4 testing services within the same facility; the remainder referred out. Availability of national guidelines for HIV/AIDS services was high. Of the 20 facilities, 70% had a copy of the national laboratory protocol, 98% had the national HCT guidelines, 80% had the national FP guidelines, 98% had the national ART guidelines, and 100% had the national TB guidelines. Pre-ART and ART Services The assessment sought to retrieve 100 patient records, five for each facility, for pre-art and ART services. Only 20% of the facilities visited had pre-art registers. Most of data were retrieved from the HIV testing register and the Cotrimoxazole prophylaxis (CTP) register. It was difficult to isolate some information as different patient identification numbers/codes were used for testing and CTP. For pre-art services, some data were found for only 65 patients. Of those, only 21.5% indicated partner counseling, 15.4% indicated the HIV type, 18.5% provided the initial WHO staging, and 12.3% provided the initial CD4 count. Only 3.1% used a WHO standard form for the initial visit. The registers for ART services were more complete: 98 patient records had valid data, and 94% of those indicated a Cotrimoxazole prescription, 93% had the patient s TB status recorded, and 98% had ART adherence assessed and demonstrated that corrective methods had been taken to improve it. Registers reviewed indicated that 58.4% of patients were classified as WHO stage 3, but only 26% indicated the date patients received ART. Patient retention was monitored in only 35% of the facilities and was reported to be high: 90% in 50% of the facilities. For PMTCT the assessment sought 400 patient records, 20 for each facility. FHI collected data and information on what happened to women from the point at which they were counseled until they received their test results. Data collectors reviewed the antenatal registers of 400 women who tested positive for HIV and gathered information on PMTCT services. Data were not complete for all patients. Three-hundred and thirty-four patient registers indicated that 86.5% of mothers and 78.1% of infants received prophylaxis, but only 20.9% of the infants began receiving CTP between six and eight weeks of age. Also, only 13.3% of the infants were tested with a definitive result and given exposed-infant clinical follow-up. Only 25.6% of the HIV-positive mothers and 20.8% of the infants were enrolled in the HIV care program. Fifty-five percent of the infants were reported to have received exclusive breastfeeding. Laboratories Seventy-five percent of the laboratories assessed had a laboratory technician in charge, with 50% reporting they rarely received updates and training. Only 15% of laboratory staff met national competence requirements. In half the laboratories, no one was assigned to lab safety, and 75% didn t have the Material Safety Data Sheet available. Challenges and Recommendations The main challenges faced by data collectors were related to incomplete patient records and the lack of an integrated and effective information system. Some of the data for pre-art were retrieved from the HIV testing register and CTP register. Most of the health facilities did not use newly introduced PMTCT registers. The assessment revealed limited documented referral and cross-referral systems for all services, both internally and externally, and also poor linkages and systematic assistance and support to CBOs that assisted vulnerable children. iv Malawi HIV/AIDS Services Quality Assessment

9 All sites offered an integrated HIV/AIDS continuum of services, including FP, TB-HIV, ART, and PMTCT. All had laboratory capacity for HIV testing, although many (70%) reported that a shortage of HIV tests occured frequently. Also, 50% of the facilities offered CD4 testing on-site, but 50% of the CD4 machines were broken at the time of the visit. Health facilities in general had good infrastructure, equipment, and supplies for HIV/AIDS services, but providers reported staff shortages, mainly for ART and CHBC. Data collection revealed important limitations in the medical records for HIV patients, leading to poor follow-up of pre-art patients and a lack of ART adherence monitoring. Antiretroviral (ARV) distribution to health facilities is not based on an estimate of needs from the facilities/providers. In some facilities, drugs were expiring before consumption. The CHBC program lacks support for the transportation and training of volunteers. At the time of the assessment, 45% of the health facilities assessed had not had male condoms available for the last three to five months, so the facilities were challenged in promoting dual protection. For PMTCT services, health information systems and data quality were very poor. Data collectors were rarely able to link mothers to infants because in many cases the facilities used different identification numbers for different services obtained by the same patient. Medical records showed a low percentage of exposed infants receiving CTP between six and eight weeks of age. Lack of written protocols and a weak supervision system for laboratories led to poor compliance with laboratory safety standards. Recommendations All facilities should devise a pre-art register to assist in tracing clients and reducing the number lost to follow-up. It is important that the HIV program be managed as an integrated part of overall services and that HIV/AIDS providers receive support from facility managers, despite the fact that they are supported by the Ministry of Health and the Global Fund to Fight AIDS, TB and Malaria. All health facilities should use the newly introduced PMTCT registers that can link women to follow-up after maternity discharge and keep data on HIV-exposed infants so that they can be traced for follow-up HIV testing. Health facilities should provide technical support to strengthen CBC and CBO programs through the District Assembly. Patients discharged from maternity wards and vulnerable children should receive continuous follow-up and care. There is a need to guarantee a continuous supply of condoms. The government should adopt a distribution system for ARVs based on health facilities demand and forecasting. The system should have mechanisms for minimizing drug expirations. Regular supervision for laboratories for quality assurance is crucial and should be done either by the Health District Management Team or an infection prevention and control coordinator. Continuing education for laboratory staff, mainly on bio-safety procedures, is also needed. Malawi HIV/AIDS Services Quality Assessment v

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11 I. BACKGROUND In 2004, the Government of Malawi initiated a series of reforms in the health sector aimed at addressing poor health outcomes amid a health human resource crisis. The Program of Work launched the Essential Health Package, which identified nine cost-effective interventions to be provided free to all Malawians, and the Emergency Human Resource Program, which focused on addressing the human resource crisis. The Program of Work has been supported and financed by the government and development partners through a sector-wide approach with a common framework for planning, budgeting, and performance monitoring. According to the United Nations General Assembly Special Session (UNGASS) Malawi HIV and AIDS Monitoring and Evaluation Report: , the number of people living with HIV on antiretroviral therapy (ART) increased from 3000 in 2003 to 312,476 just six years later. This is 73% of the projected ART need for 2010, a higher level than in many other African countries of similar population and HIV burdens. This surge is believed to be a major factor behind the decline in maternal mortality from 1120 deaths per 100,000 live births to 807 by A similar trend in infant and child mortality, also linked to greater access to ART, has Malawi on track to meet its Millennium Development Goal 4 target before In Malawi, health care is primarily provided through the Ministry of Health (MOH), the Ministry of Local Government, and non-governmental organizations (NGOs), such as Christian Mission health facilities. The health infrastructure is a three-tiered system in the public sector with four central hospitals in the main urban centers (Lilongwe, Blantyre, Zomba, and Mzuzu) and district hospitals in the remainder of the districts. Below the formal district level, the health care infrastructure consists of health centers and health posts. Health care in the public sector is free. The private sector provision of care (mostly through religious organizations) provides 40% of beds and care for 16% of the patient load. The private health sector is categorized as either for-profit or not-for-profit. A for-profit facility makes a profit on any user fee charged, while a not-for-profit facility charges a small fee for drugs. The not-for-profit faith-based organization (FBO) hospitals belong to a religious organization known as the Christian Hospital Association of Malawi. The government subsidizes the salaries of hospital personnel and drug costs. There is a dire shortage of doctors in Malawi. Vacancy rates in critical health positions are very high: In 2004, 68% of doctor, 58% of nurse, and 32% of clinician positions were unfilled (UNDP, 2010). A serious lack of skilled health workers has led to an over-reliance on volunteers to support the chronically ill at home. Despite the shortage of health workers and high levels of poverty, the Government of Malawi has introduced a public health model of care for HIV/AIDS that relies on non-physician clinicians to deliver antiretrovirals (ARVs). By December 2009, the number of public and private ART clinics in Malawi was 279 static ART clinics and 98 outreach/mobile ones. The government provides 74% of ART services in the country, according to the ART program report for the first quarter of A. Objectives of the Assessment The specific objectives of the assessment were to assess the HIV-related service quality elements of: 1. ART services including documentation practices provided at health facilities at various levels of the health system, 2. Prevention of mother-to-child transmission of HIV (PMTCT) services including documentation practices provided at selected facilities, Malawi HIV/AIDS Services Quality Assessment 1

12 3. HIV/AIDS continuum of care 1 services including documentation practices provided at health facilities at various levels of the health system, and 4. HIV/AIDS laboratory services, including availability of CD4 machines, bio-safety, and infection prevention. II. QUALITY ASSESSMENT DESIGN AND METHODS The assessment applied a descriptive cross-sectional survey methodology, with qualitative and quantitative data collection by a team of trained local data collectors coordinated by the FHI Senior Technical Officer for Quality Improvement and Health System Strengthening (STO/QI-HSS) and FHI/Malawi. Data collection tools were designed to gather information that relates to MOH guidelines for ART, PMTCT, the HIV/AIDS continuum of care, and laboratory services. Cohort data from medical records and registers were reviewed for PMTCT and ART services. The ART cohort was identified as patients who had a documented ART initiation date in their medical records within the previous 18 months. The pre-art cohort consisted of patients who began HIV care after testing HIV-positive and who had not initiated ART in the first three months of ART care. A third cohort consisted of antenatal care clients who tested HIV-positive with data for at least 18 months and their infants. A final revision of tools was conducted during the training of data collection teams to ensure clarity of the questions, accuracy of the translations, completeness of closed-ended or fixed-response choices, and the flow of the interview. Pre-testing was conducted in two selected health facilities. Data collection methods included interviews with facility managers and providers and review of patients medical records and registers. A. Site Selection and Sample Size FHI, in close collaboration with the MOH, selected 20 service delivery sites that provided integrated services and had laboratory capacity. All 20 facilities were in the Southern Region of Malawi, representing 11 health districts, as shown in Table 1. Sites were selected from various levels of the health system and included mainly (70%) public sector facilities (see Figure 1). Most (85%) of the facilities assessed were located in rural areas (see Figure 2). Table 1: Districts represented and number of facilities visited Districts (11) Facilities (20) Balaka 1 Blantyre 1 Chikwawa 2 Chiradzulu 2 Machinga 1 Mangochi 3 Mulanje 2 Mwanza 1 Nsanje 2 Thyolo 1 Zomba 4 1 A continuum of care includes care in the health facility as well as at home over the course of an illness. It involves health facility care by doctors, nurses, midwives, counselors, social workers, or other staff; community care by people within the community and through non-governmental organizations; and home care by volunteers, family, friends, and health and social service workers. 2 Malawi HIV/AIDS Services Quality Assessment

13 Figure 1: Profile of health facilities assessed Figure 2: Health facilities assessed by type of setting B. Data Collection Data collection tools were adapted from USAID Health Care Improvement Project tools used in earlier HIV/AIDS assessments in Uganda and Cote d Ivoire. They were revised initially to be consistent with Malawi National Guidelines and subsequently revised further after pre-testing. Data collectors were trained over four days (April 20 23, 2010). Training, which involved lectures, group discussions, and role plays, covered: purpose/rationale of the assessment, roles and responsibilities of data collectors and supervisors/team leaders, how to conduct/guide interviews, review of the assessment tools, recording answers, ethical issues, data quality, and survey logistics. Data were collected between April 27 and May 13, Over the two-week period and under the direction of FHI coordinators, data collectors worked in two teams concurrently to visit 20 sites in the 11 health districts. Table 2 lists the sites visited by each team. Data collection involved key informant interviews and review of medical records. For all data collected from medical records and registers, lack of documentation of care was interpreted as a failure to provide it. The supervisor of each team conducted daily meetings with team members to discuss the visits and assure quality of data. Table 2: Districts and facilities visited, 2010 Team 1 Team 2 Facility Distict Date Facility Distict Date Saint Joseph Hospital Chiradzulu April 27 Mulande DH Blantyre April 27 Saint Luke Zomba April 28 Nsanje DH Nsanje April 29 Zomba CH Zomba April 29 Chikwawa Chikwawa April 30 Cobbe Barracks Zomba April 30 Saint Montfort Chikwawa May 4 Matawale CH Zomba May 4 Trinity Mission Hospital Nsanje May 5 Machinga CH Machinga May 5 Chiradzulu Chiradzulu May 6 Balaka DH Balaka May 6 Mulanje Mission Hospital Mulanje May 7 Mangochi DH Mangochi May 7 Mulanje DH Mulanje May 10 Monkey Bay Rural Mangochi May 10 Thyolo DH Thyolo May 11 Saint Martin Mangochi May 11 Mwanza DH Mwanza May 12 te: DH means district hospital; CH means central hospital. Malawi HIV/AIDS Services Quality Assessment 3

14 C. Data Entry and Analysis The sites previously visited during the piloting of the tools were included in the analysis. The FHI STO/QI-HSS entered data into Excel worksheets. Data quality controls were employed at the point of data entry using data validation rules by checking data entry against completed data collection tools. Data identified as inconsistent during data cleaning were rechecked against the completed tools. An analysis plan was developed by the FHI Senior Technical Officer for Health Management Information Systems after data collection instruments were finalized. Data were imported into SPSS for Windows for cleaning and analysis. The SPSS analysis produced the tables, descriptive statistics, and pre-determined topical qualitative analyses used to summarize the data. For qualitative analysis of data provided in interviews, additional qualitative analyses were conducted using data-derived codes. D. Patient Information System and Data Quality Some data for pre-art were retrieved from the HIV testing register and CTP register. It was difficult to extract the information, as different numbers had been used for testing and CTP. Most sites had recorded most of their data on a patient s health passport that the patient kept. Tracking of services delivered to pre-art patients was very difficult since no proper follow-up system existed. For the PMTCT cohort, client records and registers were very poor. In general there was no documentation to show the link between mother and infant for PMTCT follow-up, and in many cases the identification number/code was not the same for antenatal care, maternity care, and PMTCT. III. FINDINGS A. HIV/AIDS Continuum of Care Services The National Guidelines for HIV Counseling and Testing state that provider-initiated HIV counseling and testing (PICT) should be offered as a standard component of comprehensive clinical management of both in-patients and outpatients. All health facilities visited provided PICT five days a week for free, and at the time of the assessment visit, 95% of the facilities had the HCT national guidelines available. Pre-test and post-test counseling is usually provided by HIV counselors (in 16 80% of the facilities) and nurses (14 70% of the facilities), both trained by the HTC coordinator (Figure 3). Figure 3: Counseling services by cadre of provider HIV counselors Nurses Clinical officers Health surveillance assistant Doctors Lab technicians 4 Malawi HIV/AIDS Services Quality Assessment

15 After testing positive, HIV patients were linked to other services within the facility to determine ART eligibility. Fifty-five percent of the facilities first referred patients to a clinician for clinical staging, 35% referred patients directly to ART services, and the remaining 10% referred them to the outpatient department for clinical staging and CD4 count (Figure 4). Figure 4: Referral for ART eligibility OPD- WHO/CD4 10% ART services 35% Clinician-WHO staging 55% Most providers interviewed (in 70% of the facilities) reported that there were linkages with support groups for HIV-positive patients in the communities. These groups comprised volunteers and community leaders. Few facilities (10%) had on-site support groups for HIV patients, and only 10% had a monitoring system to follow up with support groups (Figure 5). Figure 5: Availability of support groups for HIV patients ne 20% On-site 10% Community 70% Other findings include: All assessed facilities provided comprehensive HIV/AIDS services: HCT/PICT, ART, PMTCT, family planning, pharmacy, and tuberculosis diagnosis and treatment. All had adopted rapid HIV testing and had integrated HCT with antenatal care (ANC) services. In 90% of the sites, women with unknown HIV status could have a rapid test when they came to the maternity ward for labor. All facilities offered HIV testing to women attending ANC, but only 75% of the facilities had a feedback system for HIV-positive pregnant women referred to PMTCT, and only 20% had a system for following up with women who delivered at home. (A feedback system would prompt providers to provide PMTCT services to HIV-positive ANC clients attending for delivery care.) Seventy-five percent of the facilities reported frequent shortages of HIV testing kits. Forty-five percent of the facilities offered CD4 testing services on site, 15% collected blood samples on-site and sent them to an off-site lab, and 40% referred patients to central hospitals. CD4 machines were broken in five of the nine facilities that offered CD4 on site. Providers and patients reported that there was no support for transportation to take patients to referral centers for CD4 testing. Malawi HIV/AIDS Services Quality Assessment 5

16 Forty percent of the visited facilities offered infant diagnosis services, and 620% of those facilities (five out of the eight) offered these services five days a week. Polymerase chain reaction (PCR) for early infant diagnosis was available in only 5% of the assessed facilities. Fifty-five percent took blood samples and sent them to an off-site laboratory, and 40% referred for both blood draw and testing (Figure 6). Figure 6: Availability of PCR for early infant diagnosis On-site/blood sample and testing, 5% Referral for blood sample and testing, 40% On-site blood sample, then referral for testing, 55% Only 50% of assessed facilities had a system in place to follow up with HIV-exposed infants, 40% through home visits; the other half of facilities had no system for follow-up. Only 35% of the facilities had a monitoring system for retention of HIV-positive patients not eligible for treatment. Although 100% reported offering pre-art services, only 10% had pre-art registers in use. All facilities offered VCT services for TB patients. In addition, 95% offered TB diagnosis for HIVpositive patients, and 80% of the facilities offered TB treatment on-site (see Figure 7). However, there is only limited screening for household contacts of TB patients (done in only 20% of facilities assessed). Figure 7: Availability of TB services for HIV patients in assessed sites (n=20) 95% 80% 20% TB diagnosis TB diagnosis and treatment Screening for household contacts All facilities had a system for monitoring the quality of TB services and used supervision checklists to assess the integration of these services with HIV/AIDS services. 6 Malawi HIV/AIDS Services Quality Assessment

17 Ninety-five percent had a system for monitoring the quality of HCT services; 85% had a system for monitoring the quality of family planning (FP) services, done quarterly by health district staff. Although 80% of the facilities reported inviting partners of HIV-positive pregnant women for HIV testing, only 20% of the facilities kept partner-testing records. Eighty percent of the facilities offered FP services for HIV-positive patients, a high proportion, considering that 35% of the sites are faith-based organizations and some of these do not offer family planning. At the time of the assessment, nine facilities reported a stock-out of male condoms for the last three to five months. All the facilities had female condoms. The national HCT and TB guidelines were available at all sites, and the national FP guidelines at 80%. Ninety-five percent of the sites offered pharmacy services five days a week, and all pharmacies had Cotrimoxazole in stock. Only 55% of the health facilities had a method for contacting patients, of which 90% had an alert system to remind patients to return before their drugs ran out. Eighty-five percent of the facilities were linked with home-based care (HBC) services. HBC services are provided mainly by community members and health surveillance assistants. Key informants said there was a lack of trained volunteers and poor supervision and guidance/support from health facilities for volunteers. Eighty-five percent of the 20 community-based organizations (CBOs) visited reported providing services to children, but the services were very basic: some education and one meal per day, and most donors supporting these organizations were phasing out. Referral by CBOs to health facilities was very poor: Eight (40%) of the CBOs visited had no referral system, nine (45%) referred but had no documentation of referrals, and three (15%) had documentation of their referrals (Figure 10). Linkages between CBOs and districts hospitals were weak due to a lack of funds for transportation. Sixty-five percent of volunteers interviewed at the CBOs considered the services to be childfriendly, and 45% reported that they addressed gender-related risk factors. B. Laboratory Services As noted above, nine laboratories (45%) offered CD4 testing, but at the time of the assessment, five of nine CD4 machines were broken. The assessment also found the following relative to laboratories (see also Figure 8): Seventy-five percent of the laboratories had a lab technician in charge, but 50% reported that they rarely received updates and training. Only 15% of lab staff met national competence requirements (trained to perform whole blood and rapid HIV testing and supervised quarterly by district supervisors using a quality assurance supervisory checklist). Seventy percent of laboratories had laboratory protocols and standards available, but staff members reported not consulting them regularly. In 95% of the laboratories, staff reported not being aware of protocols for HIV test result disclosure. In 50% of the labs, no one was no assigned to lab safety, and 75% of laboratories had no Material Safety Data Sheet (MSDS) available. Only 65% of the laboratories had signs on storage areas that were consistent with the hazards within. Only 65% of lab staff were trained on safety issues. Malawi HIV/AIDS Services Quality Assessment 7

18 Figure 8: Compliance with selected lab quality standards 75% 70% 70% 65% 55% 50% 40% 20% 20% Lab tech on-site Lab protocols Labeled containers Staff trained/safety Eye protection Lab safety person Spill kits First Aid Fire extinguishers Only 70% of laboratories had primary and secondary chemical containers labeled with the chemical s identity, appropriate hazard warnings, and dates. Although 75% reported that housekeeping staff had been trained on safety issues, informal interviews with these staff indicated that the trainings didn t reach all staff. All labs had protective gloves available but only 55% had protective eyewear. All had lab coats and masks available and in use when required. Only 25% had safety showers and eye wash stations, and spill kits were observed only in 40%. First-aid supplies were not available in 80% of the labs. Fire extinguishers were available in only 40% of labs, and only 20% were checked regularly. Eighty percent of the laboratory services reported that they had staff designated for quality assurance (QA), but no formal QA training had been provided, and no QA protocols were available. C. Pre-ART and ART Services The assessment of pre-art and ART services indicated that: Pre-ART registers were found in only 20% of the health facilities. Some of the data for pre-art were retrieved from the HIV testing register and CTP register. It was difficult to extract the information, as different patient identification numbers were used between testing and CTP services. The assessment reviewed 100 medical records in the pre-art and ART cohorts. The pre-art cohort included patients who had been registered for HIV/AIDS care and did not require ART for at least the first three months thereafter. In 65% of the records, data recorded included gender and age of the patient; only 20% of the records included recording of patient marital status. Pre-ART patients medical records had very limited data on services provided. As see in Figure 9, documentation of HIV counseling was the most frequent service recorded, noted in 45% of the pre- ART records reviewed. After the initial pre-art visit, patients returned to the health facility a median of nine times in 12 months. The documentation of care was much better for ART patients. ART records assessed showed that all ART patients received ART counseling, 96% had CTP prescribed, and 95% were assessed for TB. 8 Malawi HIV/AIDS Services Quality Assessment

19 Figure 9: Services recorded at pre-art initial visit % of pre-art medical records that documented the provision of the service or information HIV counseling Partner counseling Initial WHO staging HIV type Initial CD4 counting The records also indicated that 98% of the sites were using at least one standard form after the initial visit. However, only 26 patients (26%) had a CD4 count recorded in the second six-month period, with a median of 203 cells/mm 3. Seventy-six percent of the records had the patient s most recent WHO stage recorded; 24% of the records did not indicate WHO stage. Eighty percent of the sites visited had Cotrimoxazole available, and 75% had ARVs. All facilities had adopted Triomune 30, a combination of three drugs (Stavudine 30 mg, Lamivudine 150 mg, and Nevirapine 200 mg). Ninety-five percent of the facilities had health personnel trained in ART, and 85% had the ART national guidelines available where ART services were provided. Nevertheless, ART providers complained about ARV shortages; such shortages were challenging for patients when they are referred to central hospitals to get medications, as no transportation is available. In terms of scheduling visits, 95% of the facilities did so for HIV patients not on ART, and 50% did so for monthly ART visits. Only 35% of the facilities had a system to follow up with patients who were not yet eligible for ART. Only 30% of the facilities referred patients who tested positive the same day for ART eligibility. All facilities had ART services available within the facility and had health personnel trained in ART (most were nurses). All facilities had adopted WHO clinical stage 3 or 4 as the threshold for initiation of ART, irrespective of CD4 cell count for ART initiation. Ninety percent of the sites provided post-exposure prophylaxis. Eighty-five percent of all sites reported always having the ARV adult formulation available, and 60% always had the pediatric formulation. At the time of the visit, all pharmacies had ARVs in stock, but 30% revealed that they had had ARV stock-outs during the past year. Malawi HIV/AIDS Services Quality Assessment 9

20 D. PMTCT Services The assessment of PMTCT services found similar results as were found for the other services: Data collectors faced a big challenge with the PMTCT cohort. Information systems and data quality were very poor. In general there was no documentation to link mother-infant pairs for PMTCT follow-up, and in many cases, the identification number/code was not the same for ANC, maternity, and PMTCT. Data were taken from patient registers and case notes, but due to the difficulty matching mothers with their infants, data collectors often had to use surnames, area of residence, and estimated birth dates to complete their data collection tool. They assessed 400 patient medical records. The data collectors reviewed registers and records for evidence that cohort patients received seven PMTCT care services; results are shown in Figure 10. The records showed that 86.5% of the mothers received prophylaxis, as did 78.1% of infants, but only 20.9% of the infants began receiving CTP between six and eight weeks of age. Only 13.3% of infants were tested with definitive results or given exposed-infant clinical follow-up. Only 25.6% of the mothers and 20.8% of the infants were enrolled in the HIV care program. Fifty-five percent of the infants were recorded as receiving exclusive breastfeeding. Figure 10: PMTCT services recorded 100% 90% 80% 70% 60% 50% 40% 30% 20% 10% 0% 86.5% 78.1% 20.9% 13.3% 55.0% 25.6% 20.8% Mother prophylaxis at delivery Infant prophylaxis at delivery Infant prophylaxis at 6-8 weeks Infant tested with definitive results Infant exclusively breastf ed Mother in HIV care Infant in HIV care All the sites provided PMTCT services within the same facility as the ANC services and had health personnel trained in PMTCT. All staff providing PMTCT services were nurses. Only 30% of the facilities reported that HIV testing kits were available all the time. Nevirapine and combined Zidovudine and single-dose Nevirapine (AZT-sdNVP) were always available in 90% of the sites, and CTP was always available in 85% of the sites. 10 Malawi HIV/AIDS Services Quality Assessment

21 IV. CHALLENGES AND RECOMMENDATIONS A. Issues with Cross-cutting Functions of the Health System for HIV/AIDS Services Lack of an integrated and effective information system undermines continuity of patient care. Only 20% of the facilities visited had a pre-art register in place. For PMTCT, there was no documentation to show the mother-infant link for follow-up, and in many cases the identification/code was not the same for ANC-maternity and PMTCT. Another challenge in almost all the sites was the referral system. Very few referrals were documented, and feedback/cross-referral information was rare. The most complete referrals were from TB services to HIV services. Coordination was lacking between service providers within a facility, between CBOs and health facilities; between health facilities and district hospitals; and between district hospitals and central hospitals. Formal referral methods were not used. Lack of transport was reported as the main challenge to referral to a different facility. Providers indicated that they tend not to refer, as they know that patients cannot afford transportation costs. CBOs helping vulnerable children were struggling due to reduced funding. The national program for these children was dependent on the Global Fund. A few CBOs had been supported by international institutions, such as OXFAM and Dignitas, but most of them were phasing out. Although the Social Welfare Program existed to structure and mobilize the community to support vulnerable children, it relied on the goodwill of volunteers. B. Recommendations to Address Service Quality There are many areas to address to improve the quality of HIV/AIDS services. We recommend that Malawian authorities implement a quality improvement initiative aimed at addressing the areas listed below while at the same time focusing on strengthening health systems. 1. Continuum of Care Since linkages between CBOs and health facilities were lacking, facilities should strengthen their community-based care programs for continuous follow-up and care of patients discharged from a hospital. There is a need to ensure a continuous supply of male condoms. The facilities are challenged in promoting dual protection. The failure to screen for TB patients household contacts calls for strengthening of this service. Facilities should screen clients accessing HCT for TB using a screening tool for TB symptoms and signs. Results of a definitive test should be indicated in the infant s health passport to help ensure that every exposed infant is tested. As some ARVs were expiring before consumption, the government should stop using the push system (forecasting ARVs according to a district s population) to dispense them. ARVs should be dispensed according to each facility s forecast. Assessment findings show a great need to strengthen community-based care. The District Assembly along with health facilities should have a program to assist CBOs in ensuring continuity of care for patients in the community. Malawi HIV/AIDS Services Quality Assessment 11

22 2. PMTCT All hospitals should use the new registers, which will facilitate the follow-up of mothers and infants after discharge from maternity wards. Good documentation is needed in both registers and patient case notes. There should be a follow-up system for HIV-positive mother and exposed-child pairs after discharge from the maternity ward. The system should enable following the HIV/AIDS care of the mother and child after discharge. Registers that would capture more vital information are needed. They should be kept in a safe place with restricted access. Personnel should be trained on data-keeping ethics. Clerks should be trained on data management and recording to support decision-making relative to the quality of care. 3. Pre-ART and ART Services Facilities should devise a pre-art register that will contain all the data that are in the client s profile. This will assist clients who lose their passports, make it easier to trace clients who default (since it will contain all personal data for each client), and reduce loss to follow-up). CTP registers need to be used for pre-art patients and should have additional entries to enable the capture of adequate data. Facility management to should provide more support for ART services. It is important that managers consider HIV programs as an integrated part of overall services. A pre-art register is very important for ensuring the quality of care for HIV-positive patients because it provides information on care being rendered. Providers need to follow up with defaulters but lack information for doing so in facility-based records. Patient privacy during consultations and dispensing should be ensured. 4. Laboratory Services Laboratory staff should receive continuing education, mainly on bio-safety procedures. Training should be regular and cover all cadres of staff, including cleaning staff. Equipment (e.g., CD4 machines) needs maintenance; broken machines should be fixed, and the causes of breakdowns addressed. Lab infrastructure should be improved to enable performance according to the recommended standards. Laboratory safety must be strengthened. Most safety items are not in place, and safety equipment should be procured. Communication on hazardous materials is poor and written protocols are lacking. Lab staff should improve their safety practices. Regular supervision should ensure that standard operating procedures are followed. Regular supervision for quality assurance of test results is crucial and should be provided either by the district health management team or an infection prevention coordinator. 12 Malawi HIV/AIDS Services Quality Assessment

23 V. REFERENCES Government of Malawi Guidelines for HIV Testing and Counseling (HTC). Third Edition. Kyayise AM, Kyeyagalire R, Livesley N, Kirunda I, Tumwesigye B, Kinoti S, and Kajungu D Private-for-Profit HIV/AIDS Care in Uganda: An Assessment. Technical Report. Published by the USAID Health Care Improvement Project. Bethesda, MD: University Research Co., LLC (URC). Available at: Lin Y-S, Livesley N, Nicholas D, and Nguessan J Assessment of HIV Quality of Care in Cote d Ivoire. Technical Report. Published by the USAID Health Care Improvement Project. Bethesda, MD: University Research Co., LLC (URC). Available at: Malawi National Prevention of Mother-to-Child Transmission of HIV (PMTCT) Training Package Ministry of Health Malawi Community Home-Based Care Handbook: PMTCT. United Nations Development Programme (UNDP) United Nations General Assembly Special Session (UNGASS) Malawi HIV and AIDS Monitoring and Evaluation Report: Malawi HIV/AIDS Services Quality Assessment 13

24 ANNEX: DATA COLLECTION TOOLS Quality Assessment Tool: Continuum of Care Quality Assessment Tool: PMTCT Services Quality Assessment Tool: HIV Laboratory Services Quality Assessment Tool: ART Services 14 Malawi HIV/AIDS Services Quality Assessment

25 QUALITY ASSESSMENT TOOL: CONTINUUM OF CARE Name of Reviewer Date of Review (Day-Month-Year) Name of Health Facility Location Q1 Type of facility where the observation took place The type of facility refers to the services offered. The types will vary by country, but should reflect the actual structure of health facilities available in the country. (Select one response only) Stand-alone model Integrated health facility Q2 Type of sector Sector type describes the sponsoring agency for the facility. The types will vary by country. (Select one response only) Public sector clinic NGO clinic Private clinic FBO Q3 Locality of facility (Select one response only) Urban Peri-urban Rural r infon Q4 What HIV/AIDS services do you offer at your facility? Circle if available In facility? Q4a Or referred out? Q4b 1. Voluntary Counseling and 1a. 1b. 1c. Testing 2. Provider-initiated testing 2a. 2b. 2c. and counseling 3. CD4 testing on-site 3a. 3b. 3c. 4. ANC 4a. 4b. 4c. 5. PMTCT 5a. 5b. 5c. 6. Under 18 months diagnosis 6a. 6b. 6c. of HIV 7. Pre-ART care 7a. 7b. 7c. Are these services offered 5 days a week? Q4c (Circle yes or no) Malawi HIV/AIDS Services Quality Assessment 15