EVALUATION OF INJECTION SAFETY AND HEALTH CARE WASTE MANAGEMENT IN SOUTH AFRICA

EVALUATION OF INJECTION SAFETY AND HEALTH CARE WASTE MANAGEMENT IN SOUTH AFRICA 2006 BASELINE REPORT AUGUST 2008 v

ACKNOWLEDGEMENTS The researchers and writers of this report would like to express their gratitude to the National Department of Health (NDOH) of South Africa and, more specifically, Dr. Louis Classens in his capacity as the Director of Quality Assurance; the Heads of Health Departments of all the Provinces in South Africa; and the senior staff and management of the hospitals where these injection safety and health care waste management surveys took place. We would like to thank Professor Adriano Duse, Chief Specialist and Academic Head: Division of Clinical Microbiology and Infectious Diseases for the National Health Laboratory Service and the University of the Witwatersrand School of Pathology, for his expertise and input into this report. We are grateful also to Professor Shaheen Mehtar of the Academic Unit for Infection Prevention and Control, Centre for Infectious Diseases of Tygerberg Academic Hospital and Stellenbosch University, for her insights. We are grateful to members of the Council for Health Service Accreditation of South Africa (COHSASA) staff and of the Making Medical Injections Safer (MMIS) team who collaborated on this project, as well as members of staff of the Medical Research Council of South Africa (MRC). These individuals include: From JSI: Dr. Rose Mulumba Ms. Quail Rogers-Bloch Ms. Amanda Dean Ms. Martha Mosiane Mr. Dirk van Wyk Ms. Adele Barkhuizen Ms. Sibongile Mogale Ms. Karen Van Roekel From MRC: Dr. Carl Lombard Dr. Zuzumuzi Maponya From the NDOH: Dr. Louis Classens Dr. Lindiwe Makubalo From COHSASA: Prof. Stuart Whittaker Ms. Saskia Blakeway Ms. Marilyn Keegan Ms. Monique McCusker Ms. Audrey Mack Ms. Roselyne October Part-time Fieldworkers: Ms. Keitumetse Baloyi Ms. Suzette Du Rand Ms. Anne McDermott Ms. Thandi Mngadi Ms. Mantjie Modula Ms. Beryl Mthembu Ms. Lorna Papo Ms. Cathrine Seakamela Ms. Nokuzola Siyongwana Ms. Mazta Solomons Ms. Noreen Udemans Ms. Bonita Williams Team Leaders: Dr. Chris Bloem Ms. Petro de Beer Dr. Fikile Sithole Dr. Albie van Zyl Ms. Bea Hattingh Ms. Ingrid Oerson Ms. Damaria Molepo Project Manager: Ms. Saskia Blakeway

MAKING MEDICAL INJECTIONS SAFER PROJECT IN SOUTH AFRICA MID-TERM REVIEW REPORT The authors' views expressed in this publication do not necessarily reflect the views of the OGAC, CDC or the United States Government.

Abstract: The United States President s Emergency Plan for AIDS Relief (PEPFAR), through the U.S. Centers for Disease Control and Prevention (CDC), has funded JSI Research & Training Institute, Inc. to implement the Making Medical Injections Safer (MMIS) project on injection safety in South Africa. JSI and its partners are responsible for implementing other similar projects in 10 other countries in Africa and the Caribbean. This report describes the results of the baseline evaluation on the status of injection safety and health care waste management, conducted in June 2006 by the Council for Health Accreditation in Southern Africa (COHSASA) across all nine provinces of South Africa. Recommended citation: Whittaker, S., Mulumba, R., Lombard, C., Rogers-Bloch, Q., Keegan, M., Evaluation of Injection Safety and Health Care Waste Management in South Africa: 2006 Baseline Report, August 2008 edition. Pretoria, South Africa: MMIS for the Office of the Global AIDS Coordinator, and the Department of Health and Human Services/Centers for Disease Control and Prevention. The Making Medical Injections Safer (MMIS) project is a five-year initiative funded by the President s Emergency Plan for AIDS Relief through the HHS Centers for Disease Control and Prevention (CDC), cooperative agreement # U62/CCU124534-01, contract # GSA-GS-10F-0453. Making Medical Injections Safer is implemented by JSI Research & Training Institute, Inc. in collaboration with the Program for Appropriate Technology in Health (PATH), the Academy for Educational Development (AED), and the Manoff Group. Development of this publication was supported by the CDC; National Center for HIV, STD, and TB Prevention; Global AIDS Program; and CDC under cooperative agreement #U62/CCU124534-01. Its contents are solely the responsibility of the authors and do not necessarily represent the official views of the U.S. Office of the Global AIDS Coordinator or the CDC. Making Medical Injections Safer / South Africa PO Box 53588 Menlo Park 0102, South Africa Tel: +2712-346-6940 Fax: +2712-346-2048 Email: rmulumba@jsimmis.org.za Office of the Global AIDS Coordinator SA-29, 2nd floor 2201 C. Street NW Washington, DC 20522-2920 USA Tel: 1 (202) 663-2708 www.pepfar.gov MMIS Headquarters John Snow, Inc. 1616 N. Fort Myer Drive, 11th Floor Arlington, VA 22209 USA Tel: 1 (703) 528-7474 Email: info@mmis.jsi.com www.mmis.jsi.com HHS Centers for Disease Control and Prevention National Center for HIV, STD, and TB Prevention Global AIDS Program 1600 Clifton Road, N.E. Atlanta, GA 30333 USA Tel: 1 (404) 639-3311 / 1 (800) 311-3435 www.cdc.gov/nchstp/od/gap/default.htm

CONTENTS Acronyms...7 Executive Summary...9 1. Introduction...13 2. Methodology...15 2.1 Objectives of the study...15 2.2 Sampling...15 2.3 Data collection tool...16 2.4 Data collection...17 2.5 Organization and coordination of data entry and analysis...18 2.6 Limitations...18 3. Description of the attained sample...19 4. Results of the Inventory of Injection Equipment and Products in the Main Stock Rooms of the Health Care Facilities...21 4.1 Analysis of the inventory sheets: Availability, update and evidence of stockouts by product...21 4.2 Inventory of sharps containers compared to physical inventory...22 4.3 Presence of oral formulations of common medicines...23 4.4 Interview of stock room supervisors...24 5. Observations on Materials, Equipment, and Waste Management...27 5.1 Presence and use of sharps containers in locations where injections are administered...27 5.2 Individual indicators of the disposal of used, sharp objects...27 5.3 Storage of full sharps containers...28 5.4 Tightly sealed sharps containers...29 5.5 Waste segregation...29 5.6 Biological waste lying around...29 5.7 Evidence of reuse...29 5.8 Observations on waste management...29 5.9 Waste disposal methods...30 5.10 Observations on job aids...31 6. Observations on Injection Administration Practices...33 6.1 Preparation of injections on a clean work table or tray...33 6.2 Hand hygiene...34 6.3 Cleaning the patient s skin before the injection...35 6.4 Use of new needles and syringes for injections and to reconstitute medications...36 6.5 Removing needles from the cap of multi-dose vials...38 6.6 Use of clean barriers to protect fingers when breaking glass ampoules...38 6.7 Re-capping needles after administering injections...39 6.8 Use of a sharps container for immediate disposal of used sharps...40 6.9 Information given to the patients...41 7. Interviews With Injection Providers...43 7.1 Sources of new, disposable needles and syringes...43 7.2 Recall of stockoutages of sharps containers and syringes...43 7.3 Reuse of a needle or syringe...44 7.4 Use of needle removal devices...44 7.5 Accidental needlestick injuries...44 7.6 Providers knowledge of diseases transmitted by reuse of non sterile needles...45 7.7 Injection providers vaccinated against hepatitis B...45 7.8 Injection providers who received IS training...45 7.9 Providers sources of IS information...46 7.10 Extent providers feel at risk...46 8. Interviews With Supervisors of Injection Providers...47 8.1 Availability of policies and guidelines...47 8.2 Stockouts of syringes and sharps containers...48 8.3 Supervisors perception of the quantities of syringes and sharps containers for curative services...48 8.4 Supervisors reminding subordinates about IS...48 Evaluation of Injection Safety and Health Care Waste Management in South Africa 5

8.5 Reports of accidental needlestick injuries and availability of PEP...49 9. Interviews With Waste Handlers...51 9.1 Main methods of waste disposal used...51 9.2 Disposal of ashes from incineration...52 9.3 Common problems with medical waste disposal...52 9.4 PPE availability...53 9,5 Accidental needlestick injuries...54 9.6 Waste handlers knowledge of diseases transmitted by needle stick injuries...54 9.7 Hepatitis B vaccination of waste handlers...54 9.8 Training of waste handlers...55 9.9 Waste handlers sources of information on safe disposal practices...56 9.10 Extent waste handlers feel at risk...56 10. Exit Interviews With Patients or Parents of Patients...57 10.1 Socio-demographic characteristics of the patients...57 10.2 Patients knowledge of the availability of new needles and syringes in the community...58 10.3 Patients recall of injections received in the health facility surveyed...58 10.4 Patients recall of injections received outside the health facility surveyed...58 10.5 Patients attitudes on injections...59 10.6 Recall of the most recent prescription...60 11. summary of risk factors...61 12. Recommendations...65 Appendix 1: Survey Form...71 Appendix 2: Calculation of Sample Size...103 Appendix 3: Sources of Information on Injection Safety...105 Evaluation of Injection Safety and Health Care Waste Management in South Africa 6

ACRONYMS AD BCC CDC COHSASA EC FS GP HCWM IEC IPC IV JSI R&T KZN LP MMIS MP MRC NC NDOH NW PEPFAR PEP PPE SIGN SOPs UNICEF WC WHO Auto-disable syringe Behaviour change communication U.S. Centers for Disease Control and Prevention Council for Health Service Accreditation of Southern Africa Eastern Cape Province Free State Province Gauteng Province Health care waste management Information, education, and communication Infection prevention and control Intravenous John Snow Research and Training Institute, Inc. KwaZulu Natal Province Limpopo Province Making Medical Injections Safer project Mpumalanga Province Medical Research Council of South Africa Northern Cape Province National Department of Health North West Province President s Emergency Plan for AIDS Relief Post-exposure prophylaxis Personal protective equipment Safe Injection Global Network Standard operating procedures United Nations Children s Fund Western Cape Province World Health Organization Evaluation of Injection Safety and Health Care Waste Management in South Africa 7

Evaluation of Injection Safety and Health Care Waste Management in South Africa 8

EXECUTIVE SUMMARY A key objective of the National Department of Health (NDOH) in South Africa is to improve the quality of care provided in all levels of the health care system. In the framework of implementing the U.S. government s President s Emergency Plan for AIDS Relief (PEPFAR), JSI Research & Training Institute, Inc. received technical and financial support to improve injection safety (IS) and health care waste management (HCWM) in South Africa through the support of the U.S. Centers for Disease Control and Prevention. The project, better known as Making Medical Injections Safer (MMIS), implements IS and HCWM activities in collaboration with its partners. With the goal of preparing a broad evaluation of IS, the Department of Health organized, with the support of the Council for Health Service Accreditation of Southern Africa and MMIS, this global evaluation of IS and HCWM at the project intervention sites. The IS Survey was prompted by growing concerns about poor infection control practices in health institutions, with anecdotal reports suggesting a higher order of magnitude of the problem in South Africa. This concern required that the NDOH urgently develop a response that articulated not only how to control but also how to prevent these infections. The survey is therefore built on strong evidence around the occurrence and burden of bloodborne diseases and should be seen as a contribution to improving the safety of patients, workers, communities, commodities, and health facilities in places where interventions are set. The survey comes at a time when local and global reports have alerted the international public health community to the growing threat of hospital infections in general. This report presents a descriptive baseline of the status of IS and HCWM. It was carried out through interviews, observations, and an inventory of materials in a sample of public hospitals. Data were collected from May 2 through June 30, 2006, in all nine provinces in South Africa. The target populations and survey units of this evaluation on IS and HCWM are the medicine, pediatrics, gynecologyobstetrics, surgery, central pharmacy, and laboratory departments of the 159 public hospitals included in the survey. The survey s target populations included central stock rooms, injection providers, supervisors of the staff responsible for administering injections, waste handlers, and health care recipients (patients or parents of children who just received one or more injections in the facilities covered by this evaluation). The results obtained through observations in each health facility surveyed and interviews of the target populations are presented below, accompanied by their main recommendations, in the following areas: 1. Availability of reference documents and management tools 2. Stock management in the main stock rooms of the health facilities 3. Availability of injection equipment and material for managing waste 4. Material and equipment for managing waste from accidental needlestick injuries 5. Injection administration practices for accidental needlestick injuries 6. Training in and knowledge of bloodborne diseases 7. Health care worker protection 1. AVAILABILITY OF REFERENCE DOCUMENTS AND MANAGEMENT TOOLS One of the MMIS strategies to improve injection practices is to provide support to the NDOH in establishing and providing reference documents to all stakeholders as essential support for the pre-service and in-service training of health care professionals. A lack of reference documents was noted across the hospitals surveyed. Most supervisors (an average of 80 percent) claimed to have policies and copies of guidelines from their health services on infection control, postexposure prophylaxis (PEP), and waste handling, but when researchers asked to be shown copies of these documents, less than half of the supervisors could produce them. Evaluation of Injection Safety and Health Care Waste Management in South Africa 9

2. STOCK MANAGEMENT IN THE MAIN STOCK ROOMS OF THE HEALTH FACILITIES The results obtained through observations of the main stock room at each health facility surveyed highlighted that stock cards were less commonly available for monitoring the stock of sharps containers than those that monitored standard disposable syringes. The availability of tools for managing injection equipment was noted in about 80 percent of health facilities surveyed, while only 50 percent or less of facilities had stock cards available to manage sharps containers. When data collectors examined whether those stock cards were updated or not, they found that only around 50 percent to 60 percent of stock cards for sharps containers and around 60 percent of stock cards for standard disposable syringes were up to date. Findings were similarly low when comparing the balance on the stock cards and the physical products in stock when data collectors did an inventory. For sharps containers, the data from the cards corresponded to the physical inventory in only 35 percent to 45 percent of cases. For standard disposable syringes, only about 35 percent of the stock cards were the same as the physical stock. Disposable syringes equipped with features that prevent reuse (i.e. auto-disable (AD) and retractable syringes with features that prevent reuse and accidental needlestick injuries) were essentially nonexistent in the hospitals visited for this survey. The availability and proper maintenance of management tools facilitate better monitoring of consumption patterns and regular supply of the health facilities with materials. Therefore, overall, it is recognized that the lack of a stock management system updated regularly with each change in inventory is a factor that not only limits knowing whether there were stockouts, but also avoiding them. A strategy for improving injection practices is to reduce injections to only those that are necessary. However, this strategy assumes that the health care workers who write the prescriptions for medications have a choice between injectable and non-injectable formulations. When the data collectors looked for the oral forms of Ampicillin, vitamin B12, and ibuprofen, they found that almost all facilities had the oral medications included in the list, and 97 percent had stock of all three oral medications that were on the list. 3. AVAILABILITY OF INJECTION EQUIPMENT AND MATERIAL FOR WASTE MANAGEMENT Almost all (99 percent) of injection providers reported having a stock of sharps containers in their unit. Among this group, only 8 percent had had a stockout in the six months before this survey. A higher proportion of providers (27 percent) reported stockouts for needles and syringes, with 20 percent having had a stockout for four weeks or less. Despite reports of ready availability of sharps containers, data collectors observed that 25 percent of the locations where injections were administered had no sharps containers. Supervisor interviews highlighted the fact that the number of sharps containers was generally adequate to ensure safe disposal of the used injection equipment. Of those interviewed, 87 percent confirmed having a sufficient number of sharps containers for the curative services provided to their target population. This is consistent with the 88 percent of supervisors who said that they had never had a stockout of sharps containers in the six months preceding the survey. When sharps containers were not available, the use of inappropriate receptacles increases the exposure of providers and others to accidental needlestick injuries. Of the supervisors interviewed, 86 percent thought that the quantities of needles and syringes provided to them were adequate for the curative services provided in their health care facilities. However, 25 percent of supervisors experienced stockouts of single-use disposable syringes in the six months before this survey. 4. MATERIAL AND EQUIPMENT FOR MANAGING WASTE FROM ACCIDENTAL NEEDLESTICK INJURIES Results obtained through observations of the hospitals surveyed showed that 75 percent of facilities had sharps containers in each place where injections are administered. About one-third of the health care facilities surveyed showed evidence of all three good practices for sharps object disposal (i.e. there were no overflowing or punctured safety boxes and no used sharps lying around inside any facilities or outside on their grounds). In about 40 percent of health care facilities surveyed, full sharps containers were neither tightly sealed nor stored in a location inaccessible to the public. All these variables show that current HCWM practices present factors that put the health care staff and general public at risk of accidental needlestick injuries. Also, the lack of waste segregation in many of the hospitals (48 percent) contributed to a situation in which waste that contains used injection equipment poses a risk of accidental needlestick injuries to the waste handlers. Evaluation of Injection Safety and Health Care Waste Management in South Africa 10

Chapter 9 presents the details of the specific methods of sharps waste disposal, which were obtained through interviews of waste handlers. Transportation for off-site treatment was by far the most common method, followed by low-temperature incineration. The results obtained through observations were consistent with the data obtained in the interviews. 5. INJECTION ADMINISTRATION PRACTICES FOR ACCIDENTAL NEEDLESTICK INJURIES Results obtained on general hygiene as it relates to injections showed that 24 percent of injections are not prepared in a clean space and even if the administering parties clean the patients skin, only 23 percent wash their hands before administering injections. The results on injection equipment and injection administration practices showed that the needle and syringe were removed from a sterile package in nearly all injections (97 percent), but the injection providers were not always as careful to take the needle and syringe for reconstitution from a sealed package or to remove the needle from a multi-dose bottle. Nearly 20 percent of the injection providers re-capped the needle after having finished one or more injections, and only 73 percent disposed of the used needle and syringe immediately after administering each injection by using a sharps container or a needle remover device. All these practices place providers, waste handlers, and/or patients at risk of a bloodborne disease such as HIV or hepatitis. In fact, 8 percent of injection providers interviewed in this survey and 10 percent of waste handlers had had one or more accidental needlestick injuries in the six months before the survey. 6. TRAINING IN AND KNOWLEDGE OF BLOODBORNE DISEASES Survey results showed that 61 percent of the injection providers surveyed and about half of waste handlers had received training in IS and HCWM. Almost all of the injection providers interviewed mentioned HIV spontaneously when the data collectors asked them if they knew of diseases that could be transmitted by reuse of a nonsterile needle or by an accidental injury from a contaminated needle. Hepatitis B, on the other hand, was mentioned by 64 percent of injection providers interviewed, while hepatitis C was mentioned by about 13 percent. Among the waste handlers interviewed, 90 percent said that they knew of diseases that could be transmitted by accidental injuries with a contaminated or by reuse of a needle. HIV was mentioned by 91 percent of the waste handlers interviewed. 7. HEALTH CARE WORKER PROTECTION Three quarters of the injection providers said that they had received the hepatitis B vaccine, but of those who had received it, only 60 percent had had all three doses. Among the waste handlers interviewed, the hepatitis B vaccine was not common, and only 42 percent reported having received one or more doses of the vaccine. Over 90 percent of the waste handlers interviewed mentioned at least one type of personal protection equipment that was available in their health care facility and that could protect them against accidental injuries with sharp objects. Overalls were most available, with over half of the waste handlers mentioning them; the next most-mentioned personal protective equipment (PPE) were boots or closed-toe shoes and heavy-duty gloves, which were both mentioned about 50 percent of the time. This report is organized into 12 chapters. Following the introduction in Chapter 1, the methodology is presented in Chapter 2, and a summary of the attained samples is provided in Chapter 3. Specific results drawn from the observations and interviews are detailed in Chapters 4 through 10. Chapter 11 s conclusions are focused on analyzing results in relation to their contribution to the risks of transmitting a bloodborne pathogen such as HIV and the hepatitis B or C virus. Finally, Chapter 12 summarizes recommendations. Evaluation of Injection Safety and Health Care Waste Management in South Africa 11

Evaluation of Injection Safety and Health Care Waste Management in South Africa 12

1. INTRODUCTION One of the objectives of the National Department of Health (NDOH) is to improve the quality of care provided at all levels of the health care system. In the framework of implementing the U.S. government s President s Emergency Plan for AIDS Relief (PEPFAR), JSI Research & Training Institute, Inc. (JSI) received technical and financial support to improve injection safety (IS) and health care waste management (HCWM) in South Africa through the support of the U.S. Centers for Disease Control and Prevention. The resulting project, better known as Making Medical Injections Safer (MMIS), implements IS and HCWM activities in collaboration with other partners. With the goal of preparing a broad evaluation of IS, the NDOH organized, with the support of the Council for Health Service Accreditation of Southern Africa (COHSASA) and MMIS, this global evaluation of IS and HCWM in 159 public hospitals across all nine provinces of South Africa. The protocol (ID EC06-001) was approved by the Ethics Committee of the Medical Research Council of South Africa (MRC) on March 24, 2006. According to the World Health Organization (WHO), every year, unsafe medical injections are responsible for around 8 to 16 million cases of infection with the hepatitis B virus, 2.3 to 4.7 million cases of hepatitis C, and 80,000 to 160,000 cases of HIV infection globally. Certain high-risk practices, in particular, reusing non-sterile needles and syringes, increase the risk of transmitting disease. Given the prevalence and consequences of unsafe injection practices, the WHO, in collaboration with partners through the Safe Injection Global Network (SIGN) developed and provided to countries an intervention strategy for reducing overuse of injections and promoting the administration of safe injections. The SIGN strategy is based on three objectives, to: 1. Change the behaviour of health care workers and patients to ensure safe injection practices and reduce unnecessary injections. 2. Ensure the availability of equipment and supplies needed for IS. 3. Manage waste safely and appropriately. In most developing countries, the WHO strategy is justified by the fact that beyond vaccination programs, the issue of IS and HCWM is not given appropriate attention by the governments or community of development partners. In South Africa, the burden is not well known, but a 2002 study from the Human Sciences Research Council Study of HIV and AIDS found unexpectedly high levels of HIV infection among children whose parents were not seropositive. 1 The findings of this study were further explored in a paper published in the British Journal of Obstetrics and Gynaecology. 2 The authors suggested that there was mounting evidence that rapid HIV transmission is fuelled by parenteral 3 exposures in health care settings, especially medical injections but also including transfusion of untested blood and others. 4 5 In July 2005, reports emerged that 22 babies died in one of South Africa s hospitals from a Klebsiella outbreak. An inquiry commissioned by the Minister of Health revealed that the outbreak was caused by poor IS and infection control 1 Shisana O, Simbayi L, Bezuidenhout F. Nelson Mandela/Human Sciences Research Council Study of HIV/AIDS: South African National HIV Prevalence, Behavioural Risks and Mass Media: Household Survey. Cape Town: Human Sciences Research Council Publishers, 2002 (Available at: http://www.cadre.org.za/pdf/hiv%20report.pdf. Accessed October 26, 2006) 2 Brody S, Gisselquist D, Potterat JJ, Drucker E. Evidence of iatrogenic HIV transmission in children in South Africa. Br J Obstet Gynaecol 2003;110:450 2. 3 According to AIDS info Glossary at http://www.aidsinfo.nih.gov/glossary/glossarydatacenterpage.aspx?fromletter=search&searchtext=parenteral this is Any route into the body other than through the digestive system. For example, through the veins (intravenous), into the muscles (intramuscular), or through the skin (subcutaneous). 4 Gisselquist D, Rothenberg R, Potterat J, Drucker EM. HIV infections in sub-saharan Africa not explained by sexual or vertical transmission. Int J STD AIDS 2002; 13:657 666. 5 Gisselquist D, Potterat JJ, Brody S, Vachon F. Let it be sexual: how health care transmission of AIDS in Africa was ignored. Int J STD AIDS 2003; 14:148 161. Evaluation of Injection Safety and Health Care Waste Management in South Africa 13

practices resulting in a contaminated intravenous solution being administered to several infants. 6 Intravenous equipment was also found to be the source of a similar outbreak in which six babies died at Bloemfontein's Pelonomi Hospital in the Free State Province in 2004. 7 The NDOH, together with its partners, has since been engaged in new and revived efforts to improve standards for IS and infection control in health facilities. Part of these efforts entails drafting a national policy on infection prevention and control, disseminating information, education and communication (IEC) material as well as increasing the country s capacity to prevent and control infections in health care settings. Critical to the success of such efforts is measuring improvement. MMIS, with support from the National Quality Assurance Directorate in the NDOH, has partnered with COHSASA and the MRC to conduct the first national baseline assessment of IS in public hospitals. This study was possible because of the co-operation of the Heads of Health of all nine provinces in South Africa as the first phase in implementing the MMIS project. 6 Intravenous Equipment Caused Outbreak, Health Systems Trust news report, available at http://www.hst.org.za/news/20040875. Available at www.doh.gov.za/docs/news/2005/nz0707.html 7 Ibid. Evaluation of Injection Safety and Health Care Waste Management in South Africa 14

2. METHODOLOGY This evaluation of the status of IS and HCWM is a descriptive cross-sectional baseline study. It includes interviews, observations, and stock assessments in a sample of public hospitals in all nine provinces of South Africa consisting of Eastern Cape (EC), Free State, Gauteng, KwaZulu-Natal, Limpopo, Mpumalanga, Northern Cape (NC), North West (NW), and Western Cape (WC). The town of George in WC was excluded from the sample because it recently completed a HCWM study conducted by local health authorities. The results of the HCWM study were used as a baseline for George, and the city may be included in future follow-up assessments. Public primary health clinics were not included in this assessment. The survey aimed to assess: Patterns of behaviours of health care workers and patients with a view to ensure safe injection practices through capacity building, behaviour change communication (BCC), and policy interventions. The availability of safe injection equipment and supplies through procurement and logistics interventions. The safety and appropriateness of HCWM. 2.1 OBJECTIVES OF THE STUDY The overall objective is to evaluate the general status of IS and HCWM in the health care facilities of the project s five expansion area health districts. Specific objectives are to: Evaluate the availability of the injection equipment/materials/products and stock management methods. Evaluate the availability of the collection equipment/materials, transportation and removal of waste, as well as the HCWM practices. Describe the conditions and steps for administering injections in the treatment rooms. Evaluate the existence of reference documents (national policy, norms, guidelines) with the health care staff and managers of health care facilities. Evaluate the adequacy of the quantities of injectable products ordered (vaccines, medications), injection equipment (syringes/needles), and HCWM equipment. Describe the experiences related to injections in the health care facilities and community of patients (or parents/families of patients) who received injections on the day of the survey. 2.2 SAMPLING The survey units and target populations of the IS and HCWM evaluation are the general medicine, general outpatient department, pediatrics, gynecology-obstetrics, and surgery wards as well as central stores, pharmacies, and laboratories of 159 public hospitals, including 124 district, 26 regional, and 9 tertiary facilities. A fixed total of six departments and 24 injection observations were planned for each hospital; however, not all hospitals had all six departments. Also, in South Africa, it is common to have separate departments for males and females. These wards are often in separate locations, so that a random selection of male or female departments was made before the data collection visits. Data collectors visited either the male or the female department in each facility, but not both. The sampling of health facilities assessed was obtained through stratified random sampling proportionally allocated to the regions and hospital types. To make the assumption that the other levels of sampling were random, one had to assume that the health care worker, the time of the day, and the patients present were random events that could have been observed at any other day or time of the day. It was considered that in some hospitals it would not be possible to observe four Evaluation of Injection Safety and Health Care Waste Management in South Africa 15

injections being given during the two-hour sampling interval because the hospital s injection schedule did not correspond with the timelines of the research project or because less than four injections were given in the two-hour period. No estimate of the expected under-sampling fraction was available at the department or patient level. For details on calculations of the sample size, see Appendix 2. Target populations that were planned for this survey included stock rooms (for equipment/ medications/vaccines, etc.), stock room supervisors, injection providers, supervisors of the staff responsible for administering injections, waste handlers, health care recipients (patients or parent of children who had just received an injection(s) in the study facilities), according to the following distribution: One central stock room in each health care facility, or a total of 159 stock rooms. One stock room supervisor in each facility, or a total of 159 stock room supervisors. A single person performing injections within each of the departments in the hospital, or 954 injection providers. 954 supervisors of the staff responsible for administering injections. 159 waste handlers, with 1 participant per health care facility. 3,816 recipients of health care services coming for an injection(s) in the hospitals. In addition to the people interviewed, 3,816 injection observations were planned with up to four injections observed by ward in each hospital. Observations were sought in the following areas: vaccinations, curative injections, diagnostic injections including phlebotomy, and family planning. Only direct injections were observed, and any medications administered through intravenous (IV) lines were excluded. Table 1. Table summarizing the planned sample of the target population by section of the form Section Target population Hospitals 1 Stock rooms 159 1B Stock room supervisor 159 2 Health care facilities 159 3 Injections observed 3,816 4 Injection providers 954 5 Supervisors of the staff responsible for administering injections 954 6 Waste handlers 159 7 Patients or parents of patients coming for an injection(s) at the centers 3,816 2.3 DATA COLLECTION TOOL Data were collected in the field with the aid of an MMIS questionnaire adapted to the context of the health care system in South Africa (see Appendix 1). The MMIS questionnaire includes seven components or sections related to the specific intervention areas of IS and HCWM. These sections apply to the different stakeholders, which are: Stock rooms (equipment/medications/vaccines, etc.): Section 1 Interviews with stock room supervisor: Section 1B Observations on the structure of care and the waste in each health care facility: Section 2 Observations on the practices of the injection providers: Section 3 Interviews with injection providers: Section 4 Supervisors of the staff responsible for administering injections: Section 5 Waste handlers: Section 6 Evaluation of Injection Safety and Health Care Waste Management in South Africa 16

Recipients of health care services who had just received one or more injections at the health care facilities surveyed: Section 7 2.4 DATA COLLECTION As the timeframe for project completion was restricted to eight weeks (from May 2 to June 30, 2006), COHSASA had to employ additional staff to undertake the study. An advertisement was placed in one of the most widely read newspapers in South Africa, the Sunday Times. In total, 36 applications were received and, from these, a short list of 16 candidates from various provinces (WC, Gauteng, KwaZulu-Natal, and EC) was compiled, based on relevant qualifications and experience in the field of research. To ensure objectivity, all applicants on the short list were interviewed by two members of the COHSASA staff (the Program Manager and the Legal & Corporate Affairs Manager) and evaluated according to set criteria. Successful candidates were given an official letter of appointment and were required to sign a declaration of confidentiality All of the data collectors recruited as fieldworkers were either doctors or professional nurses with practical experience in IS and data collection. The team leaders were all COHSASA employees who had been with the company for a minimum of two years and had extensive practical experience in facilitating and conducting surveys in health care facilities. COHSASA s Program Manager, who has five years of experience in this field, coordinated the project. MMIS presented a three-day training session for COHSASA staff and recruited fieldworkers. A practical session was carried out in a selected hospital in the vicinity. To clarify any areas of uncertainty, team leaders underwent a second training and feedback session after two weeks of fieldwork. Once the sample of hospitals had been selected by the MRC, a visit schedule was drawn up and fieldworkers were allocated to the various teams. EC Province was the first to be surveyed, as training had already begun there. Each team consisted of three fieldworkers, one of whom was the team leader. Nineteen fieldworkers were rotated between three to six teams per week, taking into account the province visited, the home base of fieldworkers, and the team leaders other commitments. EC, KwaZulu-Natal, and WC had two teams each because of the large number of facilities; all other provinces had one team. Fieldworkers drove or were flown to a collection point at the beginning of the week and travelled the rest of the week in one vehicle to the various hospitals. Where possible, teams stayed in bed-and-breakfast accommodations, as this proved to be more cost-effective and such establishments are more readily available. In very remote areas, field staff were accommodated in hotels in nearby towns, which were often up to a two- hour drive away from the hospital being surveyed. Four to five hospitals per week were grouped together according to location and, as much as possible, province. Only one hospital could be visited each day due to the vast distances between facilities and the fact that injection rounds at hospitals take place, for the most part, in the mornings only. In all the health facilities surveyed, the informed consent of the staff facilitated data collection. A letter was faxed to each hospital a week in advance to inform them of the intended visit without giving an exact date and time. Each province gave written approval for the research to be conducted in the selected hospitals, as did the NDOH. This was shown to the hospital management at the initial meeting. The letters and hospital contact details were given to each team leader beforehand. Team leaders collated and verified the data at the end of each visit. Data were posted to COHSASA at the end of each week and arrived on or before the Wednesday of the following week. As much as possible, all data received were taken to the MRC for entry and analysis the week after the visit. The data were disaggregated by province for certain sections. A pre-test of the data collection tool was conducted in three hospitals with the same characteristics as those surveyed in October 2005. These three hospitals were not included in the survey proper or the results presented in this report. Evaluation of Injection Safety and Health Care Waste Management in South Africa 17

2.5 ORGANIZATION AND COORDINATION OF DATA ENTRY AND ANALYSIS Data recorded on the MMIS questionnaire were entered into the Key Entry III data entry program. The data were codified before data entry, except for open-ended questions, and were analyzed using SAS Version 9.1.3. For data relating to results at the national level, sampling weights were added to the data set. The population total, strata, and clusters were specified according to the sampling plan. Weighted estimates were obtained where appropriate, along with standard errors, which reflected the sampling design. For the sections where the realization differed from the planned sample size, equal weight analyses were done and the stratification and clustering were taken into account. Provincial level estimates were done where the size of the sample realized was appropriate. 2.6 LIMITATIONS The estimate of the number of injection observations was quite different from what was planned for. Data collectors struggled to find observable injections in the two-hour time period. The survey did not include private sector or at lower-level facilities (clinics and community health centers). Evaluation of Injection Safety and Health Care Waste Management in South Africa 18

3. DESCRIPTION OF THE ATTAINED SAMPLE A total of 159 hospitals were included in the baseline study. Section 2.2 above presents the sampling plan. The sample of hospitals at the national level was completed with a 100 percent success rate. Table 2 presents the attained sample Observations of hospitals, stock rooms, stock room supervisors, and waste handlers: All of the 159 randomly sampled hospitals were surveyed. Sampling weights proportional to the number of beds in the hospital were calculated within provinces and linked to each hospital. Interviews with injection providers and supervisors: The number of departments sampled per hospital was less than the projected six per hospital. In all facilities, the number of existing prescribed units was included in the sample. No sampling or realization weights were calculated for this level, since the total number of units per facility was unknown. The realization of the sample was consistent with the distribution of the hospitals across provinces. Thus the under realization was consistent across the provincial strata. In some hospitals the same manager/nurse supervised more than one unit, thus leading to the smaller number of these subjects. Injection observations: In total, 1,680 injections were observed. This was 44 percent of the planned number of injections. Factors contributing to the realization were the smaller number of units in some hospitals and the intensity of injections use during the periods of direct observation. No sampling weight was calculated, since the potential number of injections was unknown. The realization was consistent across provinces. Patient interviews: A total 1,411 patients were interviewed about their injection experience. This is 37 percent of the planned sample size. No sampling weight was calculated, since the potential number of patients was unknown. The realization was consistent across provinces. Table 2. Attained sample Hospitals Observations Hospital 159 Stock rooms 159 Injections observed 1,680 Interviews Injection providers 624 Supervisors of the staff responsible for administering injections 578 Stock room supervisors 159 Waste handlers 159 Patients or parents of patients coming for an injection(s) at the centers 1,411 For the following analysis, results will be presented across the sample at the national level. Full provincial level results can be found under separate cover. Evaluation of Injection Safety and Health Care Waste Management in South Africa 19

Evaluation of Injection Safety and Health Care Waste Management in South Africa 20

4. RESULTS OF THE INVENTORY OF INJECTION EQUIPMENT AND PRODUCTS IN THE MAIN STOCK ROOMS OF THE HEALTH CARE FACILITIES In the health care facilities participating in this survey, data collectors evaluated the stock cards for various products such as sharps containers and injection equipment. They noted the availability of a stock card for each product, whether it had been updated in the 30 days before the survey, stockouts, and the balance indicated on the card. After collecting card data, data collectors took a physical inventory by counting all products in the stock room to compare the data from the updated stock cards to the physical stock in the stock rooms. Finally, the stocks of some common oral medications were examined. This section contains these results on products available in the main stock room of each health care facility surveyed. 4.1 ANALYSIS OF THE INVENTORY SHEETS: AVAILABILITY, UPDATE AND EVIDENCE OF STOCKOUTS BY PRODUCT 4.1.1 SHARPS CONTAINERS Of the 104 hospitals surveyed, data collectors found stock cards, registers, or computer records available for 5 L sharps containers in 50 percent of hospitals. For each stock card found, the data collector evaluated whether the card had been updated during the 30 days before this survey. In this sense, 57 percent of stock cards were up-to-date. There were only two updated cards with information on stockouts, and both of them showed a stockout during the six months before the survey. For both, the stockout lasted for one day (Tables 3 and 4). For 10 L sharps containers, there were data from 94 hospitals, of which 49 percent had stock cards, registers, or computers available; of those records available, 51 percent were updated. There were three updated records with information on stockouts, all of which showed that there had been stockouts in the last six months (Tables 3 and 4). Findings were similar for 25 L sharps containers. Of the 75 hospitals with data, 37 percent had a stock card, register, or computer record available, of which 52 percent were updated. There was one record with updated stockout information, and that hospital had experienced one stockout lasting one day (Tables 3 and 4). 4.1.2 STANDARD DISPOSABLE SYRINGES Stock cards were more common for standard single-use (disposable) syringes than for sharps containers. Of the 157 health care facilities surveyed, 82 percent had stock cards, registers, or computer records for the standard 10 ml disposable syringes. Of these 124 records, 61 percent had been updated in the 30 days before this survey. For the standard 10 ml disposable syringes, 17 updated records had data on stockouts, all of which showed a stockout in the last six months. The stockouts ranged from 1 to 84 days (Tables 3 and 4). For the standard 5 ml disposable syringes, 157 health care facilities surveyed (82 percent) had a card, register, or computer record available on the day of the survey. Of the 122 cards available, 61 percent had been updated. There were 15 cards with updated data on stockouts, all of which showed stockouts. These stockouts lasted a total of 1 to 106 days (Tables 3 and 4). Continuing with the standard 2 ml disposable syringes, of the 155 health care facilities surveyed, 83 percent had a card, register, or computer record available on the day of the survey, and 59 percent had been updated. There were 18 facilities with updated data on stockouts, all of which had experienced a stockout during the last six months. The duration of the stockouts ranged from 1 to 70 days (Tables 3 and 4). For standard 1 ml disposable syringes, 85 percent of the 126 health care facilities surveyed had a stock card, register, or computer available; 58 percent of the available records had been updated. Seven hospitals had updated data on stockouts, all of which had experienced a stockout ranging from 1 to 11 days (Tables 3 and 4). Evaluation of Injection Safety and Health Care Waste Management in South Africa 21

4.1.3 DISPOSABLE SYRINGES WITH FEATURES THAT PREVENT REUSE AND DISPOSABLE SYRINGES WITH FEATURES THAT PREVENT REUSE AND ACCIDENTAL NEEDLE STICK INJURIES Disposable syringes equipped with features that prevent reuse (for example, AD syringes) and disposable syringes with features that prevent reuse and accidental needlestick injuries (for example, retractable syringes) were essentially nonexistent in the hospitals visited for this survey. The number of records was too low to permit any analysis. Table 3. Summary of the availability of inventory cards, by product Products Card/register available Hospitals surveyed with data New, unused sharps containers 5 L 52 104 50.0 10 L 46 94 48.9 25 L 28 75 37.3 Other size 21 45 46.7 Standard disposable syringes 10 ml 129 157 82.2 5 ml 128 157 81.5 2 ml 128 155 82.6 1 ml 107 126 84.9 Percentage Table 4. Summary of the maintenance of inventory sheets for hospitals that have them, by product Products Card/register updated Card/register Available New, unused sharps containers 5 L 28 49 57.1 10 L 22 43 51.2 25 L 13 25 52.0 Other size 7 19 36.8 Standard disposable syringes 10 ml 76 124 61.3 5 ml 74 122 60.7 2 ml 72 123 58.5 1 ml 60 103 58.3 Percentage 4.2 INVENTORY OF SHARPS CONTAINERS COMPARED TO PHYSICAL INVENTORY After collecting the data presented previously on the stock cards, the data collectors performed a physical inventory, counting all the injection equipment and sharps containers in the stock room. These results were compared with the updated stock cards. There should have been the same balance on the updated stock card and in the stock room s physical stock if the stock room employees maintained them as required. For the disposable syringes equipped with features that prevent reuse (for example, AD syringes), the number of updated cards is too low to permit this analysis. Evaluation of Injection Safety and Health Care Waste Management in South Africa 22

Table 5. Inventory of sharps containers compared with the physical stock, by product Products Updated cards Data from the cards corresponds to the physical stock Percentage New, unused safety boxes 5 L 28 10 35.7 10 L 20 9 45.0 25 L 12 4 [33.3] Other size 6 4 [66.7] Standard disposable syringes 10 ml 72 26 36.1 5 ml 72 26 36.1 2 ml 69 23 33.3 1 ml 55 20 36.4 Note: Percentages are not calculated for cases with less than 15 cards. 4.3 PRESENCE OF ORAL FORMULATIONS OF COMMON MEDICINES One strategy for improving IS is to reduce the number of injections to the minimum needed to treat patients diseases appropriately. However, this strategy assumes that the health care personnel who prepare the medication prescriptions and the injection providers have a choice. To evaluate the presence or absence of this choice, the data collectors took notes on the availability of oral forms of four medicines commonly used in the health care facilities surveyed. For each medication, they evaluated whether there was a stock (of any amount) in the facility at the time of their visit. The results are similar for the three medications chosen for this analysis: Ampicilin, vitamin B12, and Ibuprofen. The oral forms of commonly used medicines are available in the hospitals surveyed in 100 percent of cases for Ampicilin, 99 percent for vitamin B12, and 99 percent for Ibuprofen. Of the facilities surveyed, 99 percent had a stock of at least one medication on this list, and 97 percent had a stock of all three medications. Only one hospital had none of the oral medications available at the time of the survey (Table 6). Table 6. Stock of oral medications Ampicillin 1 100 Percentage Number of hospitals Vitamin B12 2 98.6 Ibuprofen 3 99.5 159 Stock of at least one oral medication on this list 98.8 Stock of all oral medications on this list 96.6 1 No response was recorded in one case. 2 No response was recorded in two cases. 3 No response was recorded in one case. Evaluation of Injection Safety and Health Care Waste Management in South Africa 23