Guyana HIV Case Surveillance System Standard Operating Procedures Manual May 2013

Transcription

1 Guyana HIV Case Surveillance System Standard Operating Procedures Manual May 2013 Surveillance Unit Ministry of Health Lot 1 Brickdam Georgetown, Guyana 1

2 Table of Contents Foreword... 4 Glossary of Terms... 5 I. Mission Statement... 7 II. Introduction... 8 A. Purpose of the Standard Operating Procedures Manual... 8 B. Intended Users... 8 C. Organizational Chart... 8 D. Updated HIV Case Surveillance System and Form E. HIV Case Definitions III. HIV Case Reporting A. Definition of HIV Case Based Surveillance B. HIV Case Surveillance Form (HCSF) C. Testing Procedures and Reportable Events D. Reporting Sources E. Reporting Procedures F. Description of Data Flow Diagram for Guyana s HIV Case Surveillance System G. Program Specific Data Flow Diagrams IV. Security and Confidentiality A. Training B. Standards for Monitoring and Evaluating the HIV Case Surveillance System Appendix A1: WHO clinical staging of HIV infection for adults and adolescents with confirmed HIV infection Appendix A2: WHO clinical staging of HIV infection for children with confirmed HIV infection Appendix B: Guide for Constructing the PUID on the HIV Case Surveillance Form (HCSF) Appendix C: HIV Case Surveillance Form (HCSF)

3 Appendix D: HCSF Completion Procedures Appendix E: HCSF Initial Review Procedures Appendix F: HCSF Secondary Review Procedures Appendix G: Data Entry Procedures Appendix H: Matching Procedures

4 Foreword Epidemiological surveillance is a major public health strategy in prevention and control of HIV in developing and developed countries. The Ministry of Health (MOH), in partnership with the Centers for Disease Control and Prevention (CDC) and the National Alliance of State and Territorial AIDS Directors (NASTAD) has developed the following guidance to provide the necessary procedures to ensure a strong integrated HIV Case Surveillance System at the national level. HIV surveillance cannot be done in isolation. Hence, key stakeholders from both public and private sectors, and the national HIV prevention monitoring and evaluation programmes were involved in the effort to improve the quality and standards of the HIV Case Surveillance System. The strengthening of the HIV Case Surveillance System will serve to efficiently and accurately monitor the HIV epidemic over time by providing information on persons affected by HIV in our society. Additionally, the quality information obtained from the case based HIV Surveillance System is used to organize, plan, and implement programs in response to the HIV pandemic. Hence, the upgraded HIV surveillance information informs resource allocation, and advocacy groups; measures the burden and impact on health services; and provides information for developing broad based strategies to mitigate agents that impact HIV in Guyana. Dr. Shamdeo Persaud Chief Medical Officer 4

5 Glossary of Terms AIDS ANC ART C&T CDC CD4 CMO DOB EDB ELISA HCSF HIV HIV+ HIV MARPS M&E MCH MOH MSM NAPS NASTAD NGO PII PLWH PMTCT PUID RHO Acquired Immunodeficiency Syndrome Antenatal Care or Antenatal Clinic Antiretroviral therapy Care and Treatment Centers for Disease Control and Prevention CD4 T cells Chief Medical Officer Date of Birth Electronic HIV Surveillance Data Base Enzyme Linked Immunosorbent Assay HIV Case Surveillance Form Human Immunodeficiency Virus HIV positive HIV negative Most at Risk Populations Monitoring and Evaluation Maternal Child Health Ministry of Health Men who have Sex with Men National AIDS Programme Secretariat National Alliance of State and Territorial AIDS Directors Non Governmental Organization Personally Identifying Information People or Person Living with HIV Prevention of Mother to Child Transmission (of HIV) Patient Unique Identifier Regional Health Officer 5

6 SOP UNAIDS VCT WHO Standard Operating Procedures Joint United Nations Programme for HIV/AIDS Voluntary Counselling and Testing World Health Organization 6

7 I. Mission Statement The aim of the Ministry of Health is to improve the physical, social and mental health status of all Guyanese by ensuring that health services are accessible, acceptable, affordable, timely and appropriate as possible given available resources and enhancing the effectiveness of health personnel through continuing education, training and management systems. To achieve such goals one of the components of the National Health Sector Strategy is the strengthening of strategic information, developing a capacity to lead relevant data collection, analysis and use in planning, management and evaluation at all levels. 7

8 II. Introduction A. Purpose of the Standard Operating Procedures Manual This procedural manual (referred to as SOP henceforth) is comprehensive in scope, and intended to provide necessary information and guidance for the implementation, management and utilization of the national HIV case surveillance system across voluntary counseling and testing, HIV care and treatment, antenatal care (including prevention of mother to child transmission(pmtct)) programs and laboratories and the Blood Bank. This includes clear and descriptive instructions and roles and responsibilities for the completion of the HIV case surveillance form (HCSF), submission of HCSF forms to the appropriate administrative unit, data entry and reporting. B. Intended Users The SOP should be referenced and utilized by any and all clinical staff participating in HIV testing, care and the completion and transportation of the HCSF. Additionally, this SOP is intended for use by National AIDS Programme Secretariat (NAPS) staff, Ministry of Health (MoH) Statistical Unit staff, MoH Surveillance Unit staff, MoH Maternal Child Health (MCH) staff working in the ANC program and MoH Management Information Systems Unit (MISU). C. Organizational Chart The Ministry of Health comprises seven programmes, each with various numbers of sub programs. Six units are specifically identified to manage HIV surveillance and program data; the Surveillance Unit, Health Statistics Unit, Management Information Systems Unit, Voluntary Counseling and Testing (VCT), Prevention of Mother to Child Transmission (PMTCT) at antenatal clinics, and Care and Treatment (C&T). Together these units work collaboratively to coordinate and support all data collection, management, analysis and dissemination of HIV surveillance and program data. The Surveillance Unit coordinates the procedures for HIV surveillance data and works with the Health Statistics unit to produce high quality and reliable data reports and analyses. The National AIDS Programme Secretariat (NAPS) is located within the Disease Control program and it oversees the HIV prevention and care programs and it is the primary stakeholder to ensure HIV surveillance reports are used for program planning and decision making. Figure 1: Organizational Chart 8

9 Budgeting, Finance, Accounting & Auditing Personnel Department Human Resources Development General Administration Field Auditor Health Sector Development Unit Minister of Health Permanent Secretary Central Procurement Unit Health Planning Health Statistics Management Information System Deputy Permanent Secretary Chief Medical Officer Chief Nursing Officer Government Analyst/ Food & Drug Department Central B Pharmacy Pharmacy Medical Co General Nu Director, Disease Control Director, Primary Health Care Regional Health Services Health Sciences Education Standards & Technical Services R Port Health Vector Control Services TB/Chest Disease Hansens Disease Alexander HIV/AIDS & STDs Epidemiology & Surveillance National Public Health Reference Laboratory Veterinary Public Health Chronic, Non Communicable Diseases Mental Health Unit Maternal & Child Health Food & Nutrition Program Dental Health Environmental Health Health Education & Promotion Adolescent Health Drug Demand Reduction Services Chief MEDEX Coastal Communities Coordinator Indigenous Peoples Communities Training Programs Pre Medex & Medex Rehabilitation Pharmacy Assistant Audiology X Ray Technician Medical Laboratory Environmental Health Community Health Worker Rural & Single Trained Dental Assistant, Dentex, Community Dental Professional Nursing & Nursing Quality Assurance & Management National Blood Transfusion Service Government Pharmacy Service National Support Biomedical National Laboratory Services Radiology Unit C Nation Cent Reha 9

10 D. Updated HIV Case Surveillance System and Form In order to facilitate the scaling up of access to antiretroviral therapy (ART), in 2007 the World Health Organization (WHO) revised HIV case definitions for surveillance of HIV and the clinical and immunological classification of HIV related diseases into a universal four stage system that includes simplified standardized descriptors of clinical staging events 1. The 2007 WHO HIV surveillance recommendations call for revising the case definitions to include all stages of HIV infection and to replace AIDS case reporting with reporting of persons with advanced and severe HIV disease (clinical stages 3 and 4). There are four WHO clinical stages: stage 1 (asymptomatic), stage 2 (mild symptoms), stage 3 (advanced symptoms), and stage 4 (severe symptoms, previously referred to as AIDS). In the light of these revisions, Ministry of Health revised and upgraded the HIV case surveillance reporting form and the current HIV case reporting system to strengthen HIV case surveillance in Guyana. The upgraded MoH HIV Surveillance System: Monitors the HIV epidemic over time by requiring reporting of all HIV infected persons from each site where they present for testing or care & treatment as well as additional reports on persons diagnosed with advanced and/or severe HIV infection or who have died Tracks individual client disease progression from point of diagnosis through stage 3 and 4 Identifies the care and treatment needs of HIV infected individuals Determines the characteristics and exposure categories of persons with HIV infection Determines the region s disease burden that is attributable to HIV by measuring HIV prevalence Informs the burden and impact of HIV on health services Provides data for developing and monitoring HIV prevention programs, to inform advocacy groups, resource allocation, program planning, and monitoring and evaluation of programs. Measures trends in mortality among HIV infected persons E. HIV Case Definitions The HIV case definitions for HIV infection and advanced HIV are in accordance with the 2007 WHO case definitions 1 : 1 World Health Organization WHO case definitions of HIV for surveillance and revised clinical staging and immunological classification of HIV related disease in adults and children. 10

11 Table 1: WHO Case Definition for HIV Infection Adults and children 18 months or older HIV infection is diagnosed based on: Positive HIV antibody testing (rapid or laboratory based enzyme immunoassay). This is confirmed by a second HIV antibody test (rapid or laboratory based enzyme immunoassay) relying on different antigens or of different operating characteristics; and/or; Positive virology test for HIV or its components (HIV RNA or HIV DNA or ultrasensitive HIV p24 antigen) confirmed by a second virological test obtained from a separate determination. Children younger than 18 months HIV infection is diagnosed based on: Positive virological test for HIV or its components (HIV RNA or HIV DNA or ultrasensitive HIV p24 antigen) confirmed by a second virological test obtained from a separate determination taken more than four weeks after birth. Positive HIV antibody testing is not recommended for definitive or confirmatory diagnosis of HIV infection in children until 18 months of age. Table 2: WHO criteria for diagnosis of severe (Stage 3) advanced (Stage 4) HIV (AIDS 2 ) for reporting Clinical and immunological criteria for diagnosis of advanced HIV in adults and children with confirmed HIV infection Presumptive or definitive diagnosis of any stage 3 or stage 4 condition (see Appendix A) and/or; Immunological criteria for diagnosing advanced HIV in adults and children five years or older with confirmed HIV infection: CD4 count less than 350 per mm 3 of blood in an HIV infected adult or child. 2 AIDS in adults and children is defined as; clinical diagnosis (presumptive or definitive ) of any stage 4 condition 1) with confirmed HIV infection: OR immunological diagnosis in adults and children with confirmed HIV infection and >5 years of age; first ever documented CD4 count less than 200 per mm3 or %CD4+ <15: OR among children with confirmed HIV infection aged months first ever documented %CD4 <20: OR among children with confirmed HIV infection and less than 12 months of age first ever documented %CD4 <25. 11

12 and/or; Immunological criteria for diagnosing advanced HIV in a child younger than five years of age with confirmed HIV infection: %CD4+ <30 among those younger than 12 months; %CD4+ <25 among those aged months; %CD4+ <20 among those aged months. III. HIV Case Reporting A. Definition of HIV Case Based Surveillance HIV case based surveillance is the on going, systematic collection, analysis, interpretation, and dissemination of information about persons diagnosed with HIV. It is the method used to capture individual level information on persons with HIV infection to support public health planning. HIV case surveillance monitors the entire spectrum of the disease from the initial HIV diagnosis to advanced and severe HIV infection (AIDS), opportunistic illnesses, and death. At its core, case based surveillance is the use of a HIV case surveillance form (HCSF) containing information that pertains to one person with HIV infection. Each person can be reported multiple times but all corresponding forms are assigned the same Case Number that is unique to each person. The key advantage to case based surveillance is that it is population based. That is, the system is designed so that everyone diagnosed with HIV in the population of the country is captured by the surveillance system. It is designed to include people who test at both public and private sites of care. It collects the information needed to calculate HIV prevalence, i.e., the number of people living with HIV in the country, as well as trends among specific demographic or behavioral groups. This information is, in turn, used to plan and evaluate the effectiveness of prevention programs and plan care programs to reach those most in need. In Guyana public health ordinance No. 15 of 1934 requires that sexually transmitted diseases be reported to the national health authorities. This ordinance applies to all health care providers diagnosing and/or providing medical care and treatment to HIV infected persons. All HIV infected individuals, regardless of their stage at diagnosis, should be reported to the Chief Medical Officer s Office at the Ministry of Health using the HIV case surveillance form (HCSF) found below in Section IIIB. B. HIV Case Surveillance Form (HCSF) The HCSF is completed anytime a person tests positive for HIV, this includes initial diagnosis and individuals with known HIV status. Individuals referred to and presenting at care and treatment sites also complete the HCSF form. 12

13 Mandatory Variables for Case Reporting To count a client as an HIV case, a minimum amount of information must be reported on the HCSF. The following variables must be filled in the case report form for all persons that meet the HIV case definition: First initial of patient s first name; First initial of patient s last name; Sex; Date of birth; Region of patient/client residence at diagnosis; Result of HIV tests; Date of HIV diagnosis i.e., test date of first positive HIV test; and Date of death, if applicable. If any of the above variables are not captured on the HCSF when submitted to the appropriate NAPS and MoH staff, then staff are to follow up with the reporting site to retrieve the missing data. If site that submits the form does not have the information necessary to complete the mandatory variables, case should be checked to see if it has been reported already. If not, enter case in electronic database (EDB) for completion at a later time, should the information become available. Patient Unique Identifier (PUID) Patients are identified in the HIV case surveillance system by a patient unique identifier (PUID) that is constructed using the first initial of the patient s first name, first initial of patient s last name, sex and date of birth (DD/MM/YYYY). Because the PUID is used to differentiate between different people and the integrity of the entire reporting system depends on counting each case only one time it is critical that these four variables and the PUID be constructed as consistently as possible. In order to do that each client is asked to refer to the name, sex and date of birth on his/her birth certificate. If patient does not have a birth certificate and/or does not know what is on it they may use their national ID card. A guide is provided for anyone completing the HCSF, that provides standard language for getting the data elements of the PUID from clients. Using this language will increase consistency and reliability in creating the PUID. The HCSF PUID guide can be found in Appendix B. Case Surveillance Form by Section A copy of the HIV case surveillance report form is presented in the Appendix C. The form is comprised of six sections, with the last section relevant to MOH only. The six sections on the HIV case report form are: I. Patient Information II. Exposure Categories III. HIV test Results IV. Clinical Information on Advanced HIV 13

14 V. Reporting Facility information VI. MOH Use Only I. Patient Information Table 3: Section I Variables 14 Variable First name initial Last name initial Sex Date of birth If female, pregnant Patient unique identifier (PUID) Testing purpose If dead, date of death Street City/ Town/Village Region no. Ethnicity Description of variable First initial of patient s first name (using the name on the birth certificate). If initial is unknown replace with a 9 First initial of patient s last name (using the name on the birth certificate, no married names or nicknames; for women ask for maiden name; if more than one last name use the first last name). If initial is unknown replace with a 9 Sex as it appears on the birth certificate, regardless of how the patient presents him/herself Calendar day (DD), Month (MM), and Year (YYYY), as it appears on the patient s birth certificate (using 9s for any or all portions of the date of birth that are unknown) If patient is female, is she pregnant? PUID with 11 characters: initial of first name, initial of last name, sex (M/ F), and date of birth (DD,MM,YYYY). This includes using the #9 for unknown values as described in the initial, sex and date of birth boxes above. Identify whether this report is an initial HIV diagnosis, an Advanced HIV diagnosis or an AIDS death notification. If the initial diagnosis is made at an advance stage, check both boxes. AIDS death notification includes all deaths among persons with AIDS. Actual cause of death should be written in the right hand margin of the form. Calendar day (DD), Month (MM), and Year (YYYY) when the patient died. Replace an unknown day or month with 9 Name of street where patient resides most of the time at the time of this report Name of city/ town/ village where patient resides most of the time at the time of this report Regional location of the city/ town / village (region 1 10) of residence at the time of this report Patient s self reporting ethnicity: Afro Guyanese, Amerindian, Chinese, Indo Guyanese, Portuguese, Mixed, or Other or Refused. Indicate only one ethnicity. Indicate only one.

15 Employment status Current status of employment: employed, unemployed, student, refused. If employed, state occupation. Employed includes part time as well as full time work. For clients that are both employed and students, check both. II. Exposure Categories All applicable exposure categories are recorded on the HIV case surveillance form. An exposure category is checked if the patient acknowledges that he/she engaged in that activity at least once before the first HIV positive test result. The categories are described in Table 4, below. Table 4: Section II Variables 15 Variable Sex with male Sex with female Sex with commercial sex worker Sex with an HIV infected person Been a commercial sex worker Shared needles when using drugs Sex with multiple partners Received blood transfusion or blood components Received transplant of tissue or organ or artificial insemination Occupational exposure in health care setting or laboratory Perinatal exposure to HIV Been a victim of sexual assault Description of variable Patient had anal, oral, or vaginal sex with a male Patient had anal, oral, or vaginal sex with a female Patient had anal, oral, or vaginal sex with male or female sex worker Patient had anal, oral, or vaginal sex with a person who is infected with HIV. They do not need to have known that the sex partner was HIV infected at the time they had sex only that patient can report that they had sex with an HIV infected person at the time of HCSF completion. Patient has exchanged sex for money or other material goods Patient reported sharing needles when injecting drugs Patient had anal, oral, or vaginal sex with multiple partners in the past year Patient reported being a recipient of a blood transfusion or blood component Patient reported having received transplant of tissue or organ, or had an artificial insemination Patient reported having been exposed to blood/blood components while performing his/her job in a health care setting or laboratory Patient had been exposed to HIV through mother to child transmission (born to a HIV+ mother) Patient reported being a victim of sexual assault

16 Unknown Patient does not report how they were exposed. This option is selected by MoH if all other options are blank. It should not be checked by the person completing the form. III. HIV Test Results Table 5: Section III Variables Name of test Test type Result Test date Name of test kit used. Examples include: HIV rapid tests: Determine, UniGold, Stat Pack HIV DNA PCR ELISA: Murex HIV Western Blot Type of test used for HIV diagnosis, which includes: Antibody test: Rapid test, Enzyme linked immunosorbent assay (ELISA), Western blot Virology test: HIV DNA PCR (for children less than 18 months old) HIV test result: positive (pos), negative (neg), indeterminate (ind) Date of HIV test: calendar day (DD), month (MM), and year (YYYY) IV. Clinical and Immunological Information on Advanced HIV Table 6: Section IV Variables 16 Presenting CD4 Count/percent CD4 count below 350µL ( 5 years old) This variable does not exist on the HCSF. The only CD4 results requested on the form are the two rows below in this table (CD4 count below 350 in persons age 5 and over and CD4% in persons under age 5). However, at clinical sites staff are directed to report the first CD4 count/percent ( presenting CD4 ). They can use the CD4 count below 350µl box for cases age 5 and older or the % CD4 below 30 box for cases below age 5 to record this data. Therefore if patient is age 5 or older place presenting CD4 count in the CD4 count below 350 µl field regardless of the value of the result (i.e., regardless of the actual number). If patient is below age 5 place presenting CD4 percent in the CD4 percent below 30 field regardless of the value of the result (i.e., regardless of the actual number). CD4+ lymphocyte (CD4 cells) count below 350 cells/µl is a marker for determining advanced HIV infection among patients aged 5 years and older. Record the exact CD4 count result if below 350 cells/µl

17 % CD4 below 30 (< 5 years old) Test date Stage of disease (Stage 3 or Stage 4) Date of stage diagnosis Percent CD4 below 30% is a marker for determining advanced HIV infection among patients less than 5 years of age. Record the % of CD4 below 30 Date of test for CD4 count: calendar day (DD), month (MM), year (YYYY) The Stage 3 or Stage 4 box is ticked based on which criteria the patient meets. The staging criteria may be met by either clinical or immunologic criteria. Clinical criteria are listed in Appendices A1 and A2. For immunologic staging criteria see: WHO immunologic criteria for these Stages in the Table WHO immunological classification for established HIV infection found in Section IV of the HCSF. Record date of CD4 percent or count that corresponds to the stage checked above: calendar day (DD), month (MM), year (YYYY). V. Reporting Facility Information Table 7: Section V Variables Facility name Facility type Name of the facility where the case is reported Type of the facility where the case is reported, including: PMTCT clinic, private hospital, public hospital, private health clinic, public health clinic, TB clinic, VCT sites, and other Region Regional location of the reporting facility (regions 1 10) Date form completed Form completed by Date when the case report form is completed at the facility: calendar day (DD), month (MM), year (YYYY) Full name of staff who completes the form should be written in block letters VI. MOH Use Only (Only applicable for MOH staff) Table 8: Section VI Variables Type of report Received date Determine if the case reported is a new case or an update by searching for the PUID in the electronic data base using procedures in Section F below Data Management/Cleaning. If a case is determined to have already been reported in the database, check update. Otherwise, check new Date of the form received at the Surveillance Unit of the MOH: calendar day (DD), month (MM), year (YYYY) 17

18 Entered date Record no. Date of data entry into the electronic data base: calendar day (DD), month (MM), year (YYYY) An automated number generated from the electronic data base C. Testing Procedures and Reportable Events Multiple health facilities, program sites and providers conduct HIV testing in Guyana. These include Voluntary Counseling and Testing (VCT), Antenatal Clinics (ANC) including those that have Prevention of Mother to Child Transmission (PMTCT) programs, TB clinics, public and private clinics, providers and hospitals and private laboratories. As part of the blood safety program, the blood bank also tests all donated blood units for HIV infection and some additional infectious diseases. Both point of care testing (rapid testing) and laboratory testing (venous blood draw) are practiced in Guyana. In both situations, all positive cases are confirmed using a separate test. Indeterminate samples receive a third test as a tie breaker. Only confirmed HIV positive cases are reported. Some facilities provide HIV point of care testing and no CD4 testing is available or conducted. These include VCT sites, ANC sites with PMTCT services, and the blood bank. Clients diagnosed with HIV are referred to Care and Treatment sites for clinical management of the disease. Patients receive clinical diagnosis and immunology testing upon enrollment in care. Coded samples are sent to a laboratory for CD4 and viral load tests. Test results are recorded on the HIV test request form and returned to the requesting facility. Upon receipt of the first CD4 test results, the facility completes a new HIV case surveillance form (HCSF); then submits this form to the appropriate NAPS or MoH staff (as described in Section IIIE). All cases of HIV are reported using the HCSF when: A person is newly diagnosed with HIV at any clinical stage; An HIV infected person (regardless of whether a new diagnosis) is tested or presents for care at a site or facility for the first time; An HIV infected person has progressed to advanced HIV (stage 3); An HIV infected person has progressed to severe HIV (stage 4); and An HIV infected person dies regardless of cause of death. In summary, all HIV infected individuals should be reported when they are new to a testing or care site including VCT, C&T or ANC/PMTCT sites and private hospitals and clinics regardless of whether the client was diagnosed elsewhere. Clients are to be re reported if they are stage 3 or stage 4 or die; cause of death is to be included in reports of clients who die (See Appendix D: HCSF Completion Procedures for details). 18

19 D. Reporting Sources Sources of HIV Case Surveillance Report Forms With the system of HIV services described above, the following are locations where people are tested for HIV and, therefore, are sources of HIV case reports: VCT sites ANC sites with and without PMTCT services TB clinics Care and Treatment Sites Public and private hospitals Private providers and clinics Private laboratories At each of these sites persons who conduct HIV testing are responsible for completing the HIV Case Surveillance Form (HCSF) for all persons diagnosed with HIV. Each site is then required to submit all HCSF to the MoH/NAPS (data flow described in detail in Section IIIE below. In addition to these sources of HIV case reports, the National Public Health Laboratory Conducts CD4 testing and provides the results to requesting clinical staff who include the CD4 results in Section IV of the HCSF. Death Registry Obtaining reports of death on persons previously reported with HIV is essential to accurately measure the number of people living with HIV in Guyana. A match will be conducted annually to obtain vital status of persons reported with HIV to produce the most reliable up to date count of persons living with HIV in Guyana. A match to obtain cause of death using verified ICD 10 codes is conducted every two years. A procedure for this is in Appendix G. Reports on HIV related deaths are also acquired when: 1. Sites call clients in the event they miss an appointment, only to find out the client died; 2. Very ill clients are sent to the Hospice, who then report to the referring site in the event the client dies; 3. Family members inform site when the clients die; and 4. Outreach Officer receives this information when out in the fields checking up on clients. E. Reporting Procedures The program areas at NAPS/MoH responsible for processing HCSFs from various parts of the health sector are as follows: 19

20 VCT sites send reports to VCT staff at NAPS ANC sites with and without PMTCT services send reports to PMTCT staff at MoH TB clinics send reports to VCT staff at NAPS Care and Treatment Sites send reports to C&T staff at NAPS Public and private hospitals send reports to VCT staff at NAPS Private providers, laboratories and clinics send reports to VCT staff at NAPS The data flow for HIV case reporting between the sites listed above and NAPS and MoH through to data cleaning, analysis and dissemination is depicted in the data flow diagram below. This over view of the data flow diagram is followed by three more specific data flow diagrams for: 1) VCT, 2) C&T and 3) antenatal clinics. 20

21 Figure 2: Data Flow Diagram for Guyana s HIV Case Surveillance System 21

22 F. Description of Data Flow Diagram for Guyana s HIV Case Surveillance System The HIV Case Surveillance Process includes the steps described below. 1. Distribution of HIV Case Surveillance Forms (HCSFs) o o NAPS distributes HIV Case Surveillance Forms to all sites conducting HIV testing except ANC sites MoH PMTCT Unit distributes the HIV Case Surveillance Forms to all ANC sites 2. Completion of the HIV Case Surveillance Form (HCSF) o The completion of the HCSF occurs at: VCT sites ANC sites including those with PMTCT Programs C&T sites TB clinics Health care providers (public and private) Laboratories Blood bank o Refer to Section IIIB above for detail description of Sections I to VI of the HCSF o Sites that obtain CD4 count results from the lab are required to complete Sections I V. o PMTCT and VCT are required to complete Sections I III and V. o o After forms are completed they are submitted for HCSF processing as listed in Section 3 below within 4 weeks of patient diagnosis. However, every effort should be made to submit the HCSF as quickly as possible. Questions regarding the completion of the HCSF should be directed to the Surveillance Unit at the Ministry of Health 3. HCSF Submission to Units Conducting HCSF Processing o After completing the HCSF: VCT and C&T sites are responsible for securely transporting forms in a timely and secure manner to NAPS 22

23 o PMTCT sites are responsible for securely transporting forms in a timely and secure manner to MCH Private facilities submit HCSFs to visiting Epi nurses in a timely and secure manner. Epi Nurses are responsible for securely transporting forms in a timely manner to the Surveillance Unit. 4. HCSF Processing o HCSF Processing is completed as follows: NAPS VCT and C&T units and MoH PMTCT are responsible for completing the following tasks as outlined in the HSCF Initial Review Procedures, in Appendix D: Write date of receipt in the left hand margin, and initial Ensure that the mandatory variables are completed Identify missing, questionable, or incomplete variables, and follow up with the person who completed the form onsite to obtain missing variables Epidemiological Nurses return forms with missing, questionable, or incomplete variables, and follow up with personnel at the private facility who completed the form/s. After initial quality checks all HCSFs should be submitted to the Surveillance Unit within a week of receipt by NAPS or MoH staff. If contact needs to be made with person completing the form to clarify information every attempt should be made to submit form to the Surveillance Unit within two weeks of receipt 23 Ministry of Health Surveillance Unit completes the following tasks as outlined in the HCSF Secondary Review Procedures, in Appendix E: Write date of receipt in the left hand margin, and initial De duplication using the electronic database Complete the Report Type variable as New or Update in Section VI Assign each unique person a sequential Case Number Forms should be submitted to Statistical Unit staff for data entry within a week of receipt 5. Data Entry o Ministry of Health Statistical Unit Data Entry Clerk completes the following tasks as outlined in Data Entry Procedures in Appendix F: Complete Date Received and Entry Date in Section VI of HCSF De duplication using the electronic database Forms should be entered and filed within a week of receipt.

24 6. Data Management and Cleaning o The Statistical Unit facilitates data management and cleaning on a quarterly basis. This includes completion of the following tasks: 1. Statistical Unit Officer develops and runs a standard analytic program that produces lists of cases with potential duplicates as well as suspect, inconsistent or incomplete demographic or diagnostic information, or other questionable or discrepant data. 2. Establishes data cleaning schedule and routines (i.e., what computer programs are used and what potential discrepancies are checked for example duplicates). In the initial phase of the HIV case Surveillance System these activities will be conducted monthly to any significant or obvious errors. Once the number of errors decreases a quarterly schedule will then be established. 3. Generates a list of potential duplicates. 4. Submits results to the Surveillance Unit Staff on a monthly basis. o The Surveillance Unit then completes the data management and cleaning process by completing the following tasks: 7. Data Analysis 1. Pull paper HCSFs and compare them with the information in the electronic database to identify any discrepancies and follow up with appropriate staff to rectify. o This section contains a list of commonly used reports. However, it should not be considered a static list. What is contained in the reports and how frequently they are run is adjusted in response to the effective utilization of data for program planning, development and monitoring. Additional reports will be needed as the surveillance system matures and the data are used to plan and evaluate prevention programs and plan for care of people living with HIV AIDS (PLWH). Examples of future reports to consider are: Compare region of facility with region of patient residence to quantify how much testing of PLWH is being done outside of the patient s region of residence. You can use this type of analysis to decide where more testing services may be needed. Analyze occupation by region of residence to assist with the development of targeted prevention programs 24

25 Measure how many people are tested that do not go into care by sex, age, region, occupation, etc. Measure time between testing and entry to C&T o Twice a year the Surveillance Unit runs the following reports: Number of i) newly diagnosed HIV cases, ii) prevalent (living) HIV cases, iii) advanced HIV cases (stage 3), iv) severe HIV cases (Stage 4), v) cumulative cases and vi) deaths, stratified by: o Age group at diagnosis, For example: <1 year 1 4 years 5 12 years years years years years years years years years 50 Unknown o Sex o Region of residence at diagnosis o Race/Ethnicity o Once a year, the Surveillance Unit runs the following reports: Total number and percent of newly diagnosed HIV cases, advanced HIV cases (stage 3), and severe HIV cases (stage 4). All reported HIV cases stratified by: o Age group and sex o Region and sex (may not be applicable for all areas, depending on morbidity) o Ethnicity and sex o Exposure category and sex o Exposure category and ethnicity (may not be applicable for all categories, depending on morbidity) Trends in newly diagnosed HIV cases, advanced HIV cases and deaths, stratified by age group, sex, race and exposure category. In order to minimize the influence of reporting delay on trends such analyses is conducted on cases reported six or more months before the analysis date. This decreases the likelihood that the trends are based on incomplete data. 8. Data Dissemination 25

26 o Data is distributed to the following entities: NAPS VCT and C&T for the purpose of planning and evaluating prevention programs, planning care programs, program management, monitoring and evaluation MoH PMTCT for the purpose of program management, monitoring and evaluation Stakeholders (i.e. MoH, NAPS, funders, partners) for policy and protocol development The NAPS website for public access 26

27 G. Program Specific Data Flow Diagrams Figure 3: Data Flow Diagram for HIV Case Surveillance Forms (HCSF) Originating at Voluntary Counseling and Testing (VCT) Sites Client Presents for Testing at VCT Site: Meets with VCT Counselor Pre Test Counseling: VCT Counselor Completes Intake Form If HIV Negative If HIV Positive VCT Counselor does Post Test Counseling Client returns in 3 6 months for re testing HIV Case Surveillance Form VCT Counselor does Post Test Counseling and completes HIV Case Surveillance Form and Referral Form Client is referred to Care and Treatment Copy 3 Stays at VCT Site HIV Case Surveillance Form Copy 2 goes to Care & Treatment Referral Form goes to Care & Treatment Original Goes to NAPS VCT Unit Bottom half of Referral Form goes to VCT Site Original goes to NAPS C&T Unit Copy 2 stays at C&T Site Care and Treatment completes additional HIV Case Surveillance Form (includes CD4 count) Data Quality Checks Occur C & T Unit National AIDS Programme Secretariat VCT Unit Data Quality Checks Occur Data Quality Checks Occur Ministry of Health Surveillance Unit 27 Data Quality Checks Occur Ministry of Health Statistical Unit Data Entry Clerk

28 Description of Data Flow Diagram for HIV Case Surveillance Forms (HCSF) Originating at Voluntary Counseling and Testing (VCT) Sites Client is tested for HIV at VCT site: 1. Client presents for Testing at a VCT site. 2. VCT counselor conducts pre test counseling and completes an Intake Form. 3. VCT counselor conducts the rapid HIV test algorithm (two parallel tests) : i. If both test results indicate the client is HIV negative, the VCT counselor conducts post test counseling and encourages the client to return in 3 6 months for re testing. ii. If both test results indicate the client is HIV positive, VCT counselor continues with Step 4, described below. If one test is positive and the other is negative another test is immediately conducted at the testing site. If the tie breaker test is positive, the client is referred to care and treatment. If the tie breaker test is negative, the client is counseled and advised to return for additional testing in three months. If client is determined to be HIV positive: 4. VCT counselor conducts post test counseling and completes the following forms: Referral Form Triplicate HIV Case Surveillance Form (HCSF) Original copy (white) of the HCSF is sent to the NAPS VCT Unit so that the most legible copy is available for data entry to minimize data entry errors. Copy #2 (yellow) of the HCSF and the referral form are either given to the patient, who presents it to Care & Treatment or given to the Case Navigator who presents both the client and copy of HCSF to Care and Treatment (C&T). Copy #3 (pink) remains at the VCT reporting site 5. VCT counselor refers the client to a C&T site, and instructs the client to bring Copy #2 (yellow) of the HCSF and the Referral Form (perforated) with them when they enroll in C&T. When client is referred to Care & Treatment: 6. Client presents at C&T site with Copy #2 (yellow) of the HCSF and the Referral Form. 7. C&T staff completes a new duplicate HIV Case Surveillance Form (HCSF) at intake: C&T staff records presenting CD4 count in Section IV of the HCSF at the time client presents and checks Stage 3 or Stage 4, if applicable, based on current immunologic status and/or clinical diagnoses (See WHO immunologic criteria listed in Section IV of the HCSF or the clinical criteria in Appendix A) Original (white) copy of the HCSF is sent to the NAPS C&T Unit Copy #2 (yellow) of the HCSF remains at the C&T site 8. C&T staff presents the bottom half of the perforated referral form and sends it back to the VCT site that referred the patient. This allows the VCT staff to know that the patient enrolled in C&T. National AIDS Programme Secretariat (NAPS) 9. The NAPS VCT Unit receives the original copy (white) of the HCSF that the VCT counselor completed at the VCT site for each HIV positive client. 28

29 i. NAPS VCT Unit staff writes the date received and his/her initials in the left margin of each HCSF that he/she receives ii. NAPS VCT Unit staff does a quality check on each HCSF that he/she receives (See HCSF Initial Review Procedure for details) iii. NAPS VCT Unit staff submits all HCSFs to the Ministry of Health Surveillance Unit 10. The NAPS C&T Unit receives the original copy (white) of the HCSF that the C&T staff completed at the C&T site for each HIV positive client: i. NAPS C&T Unit staff writes the date received and his/her initials in the left margin of each HCSF that he/she receives ii. NAPS C&T Unit staff does a quality check on each HCSF that he/she receives (See HCSF Initial Review Procedure for details) iii. NAPS C&T Unit staff submits all HCSFs to the Ministry of Health Surveillance Unit Ministry of Health (MoH) 11. Ministry of Health Surveillance Unit receives 2 originals of the HCSF for each HIV positive client that enters care, one from the NAPS VCT Unit and one from the NAPS C&T Unit: i. MoH Surveillance Unit staff writes the date received and his/her initials in the left margin of each HCSF that he/she receives ii. MoH Surveillance Unit staff checks all HCSFs against the electronic database to ensure that there are no duplicates (See HCSF Secondary Review Procedure for details) iii. MoH Surveillance Unit staff assigns each unique person a Case Number (See HCSF Secondary Review Procedure for details) iv. MoH Surveillance Unit staff submits all HCSFs to the Ministry of Health Statistical Unit (Data Entry Clerk) 12. Ministry of Health Statistical Unit (Data Entry Clerk): i. The Data Entry Clerk completes Date Received and Entry Date fields in Section VI of each HCSF received ii. The Data Entry clerk checks all HCSFs against the electronic database to ensure that there are no duplicates (see Data Entry Procedure for details) iii. The Data Entry clerk enters the case into the electronic database and records the Record Number generated by the Electronic Database on the HCSF 29

30 Figure 4: Data Flow Diagram for HIV Case Surveillance Forms (HCSF) Originating at Antenatal Care (ANC) Sites Woman tests HIV Positive at Antenatal Clinic (ANC) OR at Labor and Delivery Infant is determined to be HIV Positive (Infected) Health Worker at Clinic does Post Test Counselling and completes Intake Form and HIV Case Surveillance Form HIV Case Surveillance Form Client is referred to Care and Treatment Copy 3 goes to Care & Treatment Original goes to MoH PMTCT Unit Copy 2 stays at clinic HIV Case Surveillance Form Original goes to NAPS C&T Unit Copy 2 stays at C&T Site Care and Treatment completes additional HIV Case Surveillance Form (includes CD4 count) Ministry of Health PMTCT Unit Data Quality Checks Occur C & T Unit National AIDS Programme Secretariat Data Quality Checks Occur Data Quality Checks Occur Ministry of Health Surveillance Unit Data Quality Checks Occur Ministry of Health Statistical Unit Data Entry Clerk 30

31 Description of Data Flow Diagram for HIV Case Surveillance Forms (HCSF) Originating at Antenatal Care (ANC) Sites PREGNANT WOMAN tests positive for HIV at Antenatal Clinic (ANC) 1. ANC nurse conducts post test counseling and completes the following forms: PMTCT Intake Form for Pregnant Women Triplicate HIV Case Surveillance Form Original copy (white) of the completed HCSF is sent to the MoH PMTCT Unit so that the most legible copy is available for data entry to minimize data entry errors. Copy #2 (yellow) of the completed HCSF remains at the ANC reporting site Copy #3 (pink) of the completed HCSF is given to the patient, who brings it to Care & Treatment (C&T) INFANT born to an HIV positive mother is determined to be HIV positive (infected): 1. Health worker conducts post test counseling with mother and completes the following forms: PMTCT Intake Form for Exposed Infants (Post Delivery). Triplicate HIV Case Surveillance Form Original copy (white) of the completed HCSF is sent to the MoH PMTCT Unit so that the most legible copy is available for data entry to minimize data entry errors. Copy #2 (yellow) of the completed HCSF remains at the ANC reporting site Copy #3 (pink) of the completed HCSF is given to the patient, who brings it to Care & Treatment (C&T) When HIV positive pregnant woman AND/OR HIV positive infant is referred to Care & Treatment: 2. Client presents at C&T site with Copy #3 (pink) of the HCSF. 3. C&T staff completes a new duplicate HIV Case Surveillance Form (HCSF) at intake: C&T staff records presenting CD4 count in Section IV of the HCSF at the time every client presents and checks Stage 3 or Stage 4, if applicable, based on current immunologic status and/or clinical diagnoses (See WHO immunologic criteria listed in Section IV of the HCSF or the clinical criteria in Appendix A) Original (white) copy of the HCSF is sent to the NAPS C&T Unit Copy #2 (yellow) of the HCSF remains at the C&T site Ministry of Health PMTCT Unit 4. The Ministry of Health PMTCT Unit staff will receive original copy (white) of the HCSF for every HIV positive pregnant woman and every HIV infected infant: i. MoH PMTCT Unit staff writes the date received and his/her initials in the left margin of each HCSF that he/she receives ii. MoH PMTCT Unit staff does a quality check on each HCSF that he/she receives (See HCSF Initial Review Procedure for details) 31

32 iii. iv. MoH PMTCT Unit staff records the PMTCT codes in the margin of each HCSF that he/she receives PMTCT unit then submits HCSF to the Surveillance Unit. Ministry of Health (MoH) 5. Ministry of Health Surveillance Unit receives two originals of the HCSF for each HIV positive client that enters care, one from the PMTCT Unit and one from the NAPS C&T Unit: i. MoH Surveillance Unit staff writes the date received and his/her initials in the left margin of each HCSF that he/she receives ii. MoH Surveillance Unit staff checks all HCSFs against the electronic database to ensure that there are no duplicates (See HCSF Secondary Review Procedure for details) iii. MoH Surveillance Unit staff assigns each unique person a Case Number (See HCSF Secondary Review Procedure for details) iv. MoH Surveillance Unit staff submits all HCSFs to the Ministry of Health Statistical Unit (Data Entry Clerk) 6. Ministry of Health Statistical Unit (Data Entry Clerk): v. The Data Entry clerk completes Date Received and Entry Date fields in Section VI of each HCSF received vi. The Data Entry clerk checks all HCSFs against the electronic database to ensure that there are no duplicates (see Data Entry Procedure for details) vii. The Data Entry clerk enters case into the electronic database and records the Record Number generated by the Electronic Database on the HCSF 32

33 Figure 5: Data Flow Diagram for HIV Case Surveillance Forms (HCSF) Originating at Care and Treatment (C&T) Sites Health Worker at Care and Treatment completes NEW HIV Case Surveillance Form (INCLUDING CD4 COUNT) when: Patient presents for the first time Patient advances to Stage 3 Patient advances to Stage 4 Patient dies HIV Case Surveillance Form Original goes to NAPS C&T Unit Copy 2 stays at C&T Site Data Quality Checks Occur C & T Unit National AIDS Programme Secretariat Data Quality Checks Occur Ministry of Health Surveillance Unit Data Quality Checks Occur Ministry of Health Statistical Unit Data Entry Clerk 33

34 Description of Data Flow Diagram for HIV Case Surveillance Forms (HCSF) Originating at Care and Treatment (C&T) Sites Care & Treatment staff complete the HIV Case Surveillance Form: 1. A Health Worker at a Care & Treatment (C&T) site completes a new duplicate HIV Case Surveillance Form at each of the following times: i. An HIV positive patient presents for care for the first time ii. A patient advances to Stage 3 iii. A patient advances to Stage 4 iv. A patient dies Every time a health worker at a C&T site completes a HCSF, he/she includes the CD4 count in Section IV of the HCSF and checks Stage 3 or Stage 4, if applicable, based on current immunologic status and/or clinical diagnoses (See WHO immunologic criteria listed in Section IV of the HCSF or the clinical criteria in Appendix A) 2. Health worker at C&T submits the original (white) copy of the completed HCSF to the NAPS C&T Unit so that the most legible copy is available for data entry to minimize data entry errors. Copy #2 (yellow) of the HCSF remains at the C&T reporting site National AIDS Programme Secretariat (NAPS) 3. The NAPS C&T Unit will receive Copy #2 (yellow) of the HCSF that the C&T staff completed at the C&T site for each HIV positive client that enters care: i. NAPS C&T Unit staff writes the date received and his/her initials in the left margin of each HCSF that he/she receives ii. NAPS C&T Unit staff does a quality check on each HCSF that he/she receives (See HCSF Initial Review Procedure for details) iii. NAPS C&T Unit staff submits all HCSFs to the Ministry of Health Surveillance Unit Ministry of Health (MoH) 4. Ministry of Health Surveillance Unit receives 2 originals of the HCSF for each HIV positive client that enters care, one from the NAPS VCT Unit and one from the NAPS C&T Unit: i. MoH Surveillance Unit staff writes the date received and his/her initials in the left margin of each HCSF that he/she receives ii. MoH Surveillance Unit staff checks all HCSFs against the electronic database to ensure that there are no duplicates (See HCSF Secondary Review Procedure for details) iii. MoH Surveillance Unit staff assigns each unique person a Case Number (See HCSF Secondary Review Procedure for details) iv. MoH Surveillance Unit staff submits all HCSFs to the Ministry of Health Statistical Unit (Data Entry Clerk) 5. Ministry of Health Statistical Unit (Data Entry Clerk): i. The Data Entry clerk completes Date Received and Entry Date fields in Section VI of each HCSF received 34

35 ii. iii. The Data Entry clerk checks all HCSFs against the electronic database to ensure that there are no duplicates (see Data Entry Procedure for details) The Data Entry clerk enters case into the electronic database and records the Record Number generated by the Electronic Database on the HCSF IV. Security and Confidentiality HIV continues to be associated with social stigma and any breach of confidentiality poses risks of social, mental, economic and physical harm to HIV infected individuals. To ensure the confidentiality of HIV infected patients, their information must be kept in secured areas and staff must rigorously protect patient confidentiality. HIV case surveillance data collection, storage, transmission and use should follow procedures to protect any personally identifying information (PII). The policies below apply to any location where patient information is kept: clinics, laboratories, hospitals, NAPS and MoH offices. Personally Identifying Information (PII) PII is more than name. It includes any information that could potentially identify an individual. On the HCSF PII includes initials of first and last name, date of birth and all components of the patient address. Therefore any HCSF that has any PII will be protected as if it had the patient name on it. Physical Data Storage All paper HIV case report forms that contain any PII, including those that remain in the reporting facility and at MOH, must be filed and stored in a secure place such as a locked filing cabinet that cannot be accessed by un authorized staff nor patients in the waiting area or any other members of the general public. Forms containing PII must not be left out on desks or in an unsecured file folder or envelope when the person working at the desk leaves. If someone comes over to the desk of an employee working with forms with PII they must be covered. Transporting Confidential Information When transporting completed HCSFs they must be placed in a sealed envelope and placed in the trunk or other covered area of the vehicle. Any stops between the facility completing the forms and the destination should be kept to a minimum. Workers transporting the data should discuss with their supervisor whether the forms are more secure being brought with the employee or kept in the vehicle. Electronic Data Storage 35

36 Electronic data base should be password protected and accessed using a password secured.computer that is backed up on a server and cannot be accessed by un authorized staff Data must be backed up regularly. Oaths of Confidentiality All employees with access to PII should read and sign the confidentiality oath upon obtaining access to PII and annually. Security and Confidentiality Training All HIV healthcare providers and MoH and NAPS staff who have access to or work with HCSFs or other forms with personally identifying information should be trained on confidentiality and security procedures. An annual training should be held, that includes re signing the oath. Breach Procedures A process for identifying and investigating breaches in security and confidentiality includes: o Forms for reporting breaches and procedures for completing them should be developed. o Consequences for violating confidentiality and security should be developed, and staff educated on the ramifications for violating policies and procedures. A. Training Sites that complete HCSF are trained minimally on an annual basis. Such training can be conducted in person or an online training for sites to access directly. Points to be covered in such trainings are outlined in HCSF Completion Procedures in Appendix H and should include adherence to security and confidentiality procedures. B. Standards for Monitoring and Evaluating the HIV Case Surveillance System HIV case reporting data needs to maintain minimum quality standards to ensure the system is responsive and relevant to reflect who is living with and dying from HIV. The quality of the data is regularly monitored, and results used to strengthen the relevant components through training. Periodic evaluation of the HIV case surveillance system includes measures for timeliness, completeness of reporting, and validity. These analyses are run by the MoH Statistical Unit Officer and reviewed by the Surveillance Unit. The purposes of monitoring and evaluating the HIV case surveillance system are to determine: 36

37 Completeness: to measure what proportion of the diagnosed HIV cases are captured; Timeliness: to measure how soon cases are reported after diagnosis; and Validity: to evaluate the accuracy of data reported. Completeness Completeness of reporting refers to the proportion of all true HIV positive cases that are reported to the MoH. In order to monitor completeness, additional case finding methods should be found. Examples would include 1) lists of HIV discharge codes from places where people with HIV receive care and 2) program monitoring data from VCT, C&T and PMTCT to compare to the number of unique HCSFs received monthly by the designated unit (See IIE above). Because patients may not get into care once they are diagnosed, completeness measures are conducted on diagnostic tests not using measures such as CD4 tests that are only conducted on persons in care. NPHRL registries are periodically reviewed to assess the completeness of reporting of persons who present for care. In addition to determining the completeness of the HIV surveillance system, staff who process forms (See IIE above) follow up with the corresponding facility on cases not found in the HIV surveillance databases to have the HCSF completed. Timeliness Timeliness measures the time between diagnose and reported to MoH. Timeliness is measured by two methods: 1. Median time between diagnosis of HIV or advanced/severe HIV and HIV case report form received by the unit designated in IIE above. 2. Proportion of the reported cases that are received by the unit designated in IIE above within three months, six months and twelve months of diagnosis. Standards The standards that the HIV case surveillance system strives to achieve are: 66% of cases reported within six months of diagnosis 85% of cases reported within twelve months of diagnosis Below are the steps needed to calculate timeliness of HIV reporting, which requires the use of date of diagnosis and date case is first received by the unit designated in IIE above. Step 1: Calculate completeness of reporting at 12 months after the diagnosis. If completeness is 85%, then go to Step 2. Step 2: Calculate time (number of months) from diagnosis to report: = (report date) (diagnosis date) 37 = [(year of report)*12) + month] [((year of diagnosis)*12) + month]

38 Validity For example, the report date is May 2004 and the diagnosis date is November The time interval (in months) is: [(2004*12) + 5] [(2003*12) + 11] = 6 months Step 3: Determine the number of cases with a time to report 6 months. Step 4: Calculate timeliness of case reporting: Number of cases diagnosed within a year and reported within six months of diagnosis Number of cases diagnosed and reported for that diagnosis year Validity measures the extent to which the information 1) on the case report form matches information in the patient record at the health care facility as well as 2) in the electronic data base matches what is on the HCSF. I. Case surveillance form/health care facility data validity The validity of the information recorded on the HCSF compared to what is recorded in the patient s VCT or C&T or other medical record can be measured by re abstracting data on previously reported cases and comparing the information contained in the original and reabstracted forms. Step 1: Staff not previously involved with the data or site does the re abstraction check. This person works for the national surveillance program and is familiar with the case report forms and methods for reviewing clinic records, abstracting data and completing the case report form. allow. Step 2: A random sample of cases at a site is chosen 5% chosen randomly if staffing levels Step 3: At the site, go back to patient records or registry for persons chosen as the sample. Complete a new HCSF. Be sure to only review the data that was available at the time of the initial report and to exclude data received since the initial report was completed. Step 4: Compare the information on the original form and the one completed during the reabstraction phase. Step 5: Record the discrepancies and summarize accuracy for each variable. II. Case surveillance form/electronic data base validity The validity of the information entered into the electronic data base compared to what is recorded on the HCSF can be measured by re entering the data on a sample of HCSFs. The specific method for 38

39 doing this depends on how the EDB is structured. Ideally one would be able to re enter it and identify it as re entry so it does not overwrite the original form. Step 1: Select a staff person familiar with the form and data entry to perform this step. One of the staff from the Surveillance Unit involved in the secondary review of the forms would be ideal. Step 2: Randomly select 5% of entered cases (if staffing levels allow) Step 32: Re enter the form methods to be determined after consulting with MISU Alternative to Step 3: Visually compare what is on the HCSF with what has been entered. Step 4: Calculate the proportions of errors for each data field. Separate out errors that will affect how the data are analyzed from those that should be corrected but which have less impact on the data reports. 39

40 Appendix A1: WHO clinical staging of HIV infection for adults and adolescents with confirmed HIV infection Clinical Stage 1 (Asymptomatic) 1. Persistent generalized lymphadenopathy Clinical Stage 2 (Mild) 1. Moderate unexplained weight loss (<10% of presumed or measured body weight) 2. Recurrent respiratory tract infections sinusitis, tonsillitis, otitis media and pharyngitis) 3. Herpes zoster 4. Angular cheilitis 5. Recurrent oral ulceration 6. Papular pruritic eruptions 7. Seborrhoeic dermatitis 8. Fungal nail infections Clinical Stage 3 (Advanced) 1. Unexplained severe weight loss (>10% of presumed or measured body weight) 2. Unexplained chronic diarrhoea for longer than one month 3. Unexplained persistent fever (above 37.6 C intermittent or constant, for longer than one month) 4. Persistent oral candidiasis 5. Oral hairy leukoplakia 6. Pulmonary tuberculosis (current) 7. Severe bacterial infections (such as pneumonia, empyema, pyomyositis, bone or joint infection, meningitis or bacteraemia) 8. Acute necrotizing ulcerative stomatitis, gingivitis or periodontitis 9. Unexplained anaemia (<8 g/dl), neutropaenia (< per litre) or chronic thrombocytopaenia (< per litre) Clinical Stage 4(Severe) (AIDS) 1. HIV wasting syndrome 2. Pneumocystis pneumonia 3. Recurrent severe bacterial pneumonia 4. Chronic herpes simplex infection (orolabial, genital or anorectal of more than one month s duration or visceral at any site) 40

41 5. Oesophageal candidiasis (or candidiasis of trachea, bronchi or lungs) 6. Extrapulmonary tuberculosis 7. Kaposi s sarcoma 8. Cytomegalovirus infection (retinitis or infection of other organs) 9. Central nervous system toxoplasmosis 10. HIV encephalopathy 11. Extrapulmonary cryptococcosis including meningitis 12. Disseminated non tuberculous mycobacterial infection 13. Progressive multifocal leukoencephalopathy 14. Chronic cryptosporidiosis (with diarrhoed) 15. Chronic isosporiasis 16. Disseminated mycosis (coccidiomycosis or histoplasmosis) 17. Recurrent non typhoidal Salmonella bacteraemia 18. Lymphoma (cerebral or B cell non Hodgkin) or other solid HIV associated tumours 19. Invasive cervical carcinoma 20. Atypical disseminated leishmaniasis 21. Symptomatic HIV associated nephropathy or symptomatic HIV associated cardiomyopathy 41

42 Appendix A2: WHO clinical staging of HIV infection for children with confirmed HIV infection Clinical stage 1 Asymptomatic Persistent generalized lymphadenopathy Clinical stage 2 Unexplained persistent hepatosplenomegaly Papular pruritic eruptions Fungal nail infection Angular cheilitis Lineal gingival erythema Extensive wart virus infection Extensive molluscum contagiosum Recurrent oral ulcerations Unexplained persistent parotid enlargement Herpes zoster Recurrent or chronic upper respiratory tract infections (otitis media, otorrhoea, sinusitis or tonsillitis) Clinical stage 3 Unexplainedi moderate malnutrition or wasting not adequately responding to standard therapy Unexplained persistent diarrhoea (14 days or more) Unexplained persistent fever (above 37.5 C intermittent or constant, or longer than one month) Persistent oral candidiasis (after first 6 8 weeks of life) Oral hairy leukoplakia Acute necrotizing ulcerative gingivitis or periodontitis Lymph node tuberculosis Pulmonary tuberculosis Severe recurrent bacterial pneumonia Symptomatic lymphoid interstitial pneumonitis Chronic HIV associated lung disease including brochiectasis Unexplained anaemia (<8 g/dl), neutropaenia (< per litre) and or chronic thrombocytopaenia (< per litre) iunexplained refers to where the condition is not explained by other causes. Clinical stage 4 * Unexplained i severe wasting, stunting or severe malnutrition not responding to standard therapy Pneumocystis pneumonia 42

43 Recurrent severe bacterial infections (such as empyema, pyomyositis, bone or joint infection or meningitis but excluding pneumonia) Chronic herpes simplex infection (orolabial or cutaneous of more than one month s duration or visceral at any site) Oesophageal candidiasis (or candidiasis of trachea, bronchi or lungs) Extrapulmonary tuberculosis Kaposi sarcoma Cytomegalovirus infection: retinitis or cytomegalovirus infection affecting another organ, with onset at age older than one month Central nervous system toxoplasmosis (after one month of life) Extrapulmonary cryptococcosis (including meningitis) HIV encephalopathy Disseminated endemic mycosis (coccidiomycosis or histoplasmosis) Disseminated non tuberculous mycobacterial infection Chronic cryptosporidiosis (with diarrhoed) Chronic isosporiasis Cerebral or B cell non Hodgkin lymphoma Progressive multifocal leukoencephalopathy Symptomatic HIV associated nephropathy or HIV associated cardiomyopathy *Some additional specific conditions can also be included in regional classifications (such as reactivation of American trypanosomiasis [meningoencephalitis and/or myocarditis] in the WHO Region of the Americas, disseminated penicilliosis in Asia and HIV associated rectovaginal fistula in Africa). 43

44 Appendix B: Guide for Constructing the PUID on the HIV Case Surveillance Form (HCSF) Introduction to Users We are requiring the use of a guide to collect both the information to create the PUID as well as to collect all of the information required from the client to complete the HCSF. Text in boxes contains notes to the person reading the guide. The remaining text is what is to be asked of the client/patient. All questions are to be asked of all clients who test positive for HIV, male and female. Begin Here We test for HIV by creating a code, not by using your name. In order to accurately count the number of HIV cases in Guyana we need to make sure that people are not counted more than once. In order to do this we create a code for you that should be unique and be the same any time you come to get tested. I will not be asking your name but need your help in creating an accurate code. I need the first initial of your first name and first initial of your last name. If you think the patient seems confused you can say: For example, my name is [name of tester] Jane Smith so the first initial of my first name is J and the first initial of my last name is S. Thinking of the name you were given at birth and the first and surname (maiden name for women) that are on your birth certificate (no nicknames or married names). If patient is a married woman and seems concerned or offended by not using her married name explain that we are using the name on the birth certificate because it doesn t change and aids in consistency. You can reassure her in whatever way seems appropriate. For example, telling her that you are not telling her not to use her married name; this request is only to aid in constructing a code. If patient does not have a birth certificate and/or does not know what is on it they may use their national ID 1) card. What Let is them the first know initial they are of to your use first it each name? time they are asked the first initials of their first name and surname. 2) What is the first initial of your maiden name or surname? No married names unless using ID card and then can use whatever last name is on it 44 If only one name is known use a 9 to replace the unknown initial (either first or last) If more than one first name use the first name listed If more than one last name use the first last name listed

45 3) What sex is on your birth certificate? Record whatever sex the person says is on their birth certificate even if s/he appears to be a different sex. 4) What is your date of birth? For days less than 10 include 0 before the number (for example, 01 for January) If day is unknown use 99 If month is unknown use 99 If year is unknown use

46 Appendix C: HIV Case Surveillance Form (HCSF) 46