Premarital Screening Standard. Premarital Screening and Counseling Program. Version 1.1

Transcription

1 Premarital Screening Standard Premarital Screening and Counseling Program Version 1.1 July 2013

2 Table of Contents Page Table of Contents 1 Table of Appendixes 2 Abbreviation list 3 Introduction 4 PS.1 Roles and Responsibilities 5 PS.2-5 Premarital Screening: Overall Process 5 PS.6 PS.7 PS.8-9 Documents required from Applicants applying for premarital screening edical Contents of the Premarital Screening Registration, Records, Reports & Notifications 6 7 PS. 10 Single report certificate 8 PS.11 Program Package Price, Service Activities 8 PS.12 General Requirements for Clinical Laboratory 9 Services PS.13 Quality Control and Risk Analysis 10 PS.14 Screening to Detect Haemoglobinopathies 10 PS.15 Screening to Identify AB0 and Rh(D) Blood Group 10 PS.16 PS.17 Screening to Detect HIV, Hepatitis B, Hepatitis C, and Syphilis Turnaround Time for Screening to Detect Haemoglobinopathies, Blood group AB0 and Rh(D), HIV, Hepatitis B, Hepatitis C and Syphilis, Rubella

3 immunity and Hepatitis B immunity PS.18 Storage and Forwarding of Specimens for Confirmatory Testing 12 PS.19 Screening for Immunity to Rubella 13 PS.20 Vaccination for Rubella 13 PS Vaccination for Hepatitis B 14 PS.23 Vaccination for Human Papilloma virus 14 References 14 Table of Appendixes Appendix 1 Appendix 2 a Appendix 2 b Appendix 3 Premarital Screening Flowchart Premarital Screening and Counseling Program with Frequently Asked Questions English Premarital Screening and Counseling Program with Frequently Asked Questions Arabic Premarital Screening & Counseling Form Appendix 4 Appendix 5 Appendix 6 Appendix 7 a The Genetic counseling institutions in Emirate of Abu Dhabi Basic Components of premarital activities (edical Examination and Laboratory Testing) Premarital edical Examination Agreement (For Applicant) Premarital Risk Assessment - English Appendix 7 b Premarital Risk Assessment - Arabic Appendix 8 Appendix 9 Appendix 10 Premarital Screening & Counseling Report Agreement delegation form Applicant declaration of informed premarital screening results - 2 -

4 Appendix 11 Appendix 12 Appendix 13 Appendix 14 Single report Certificate Premarital Screening for Carrier Identification of haemoglobinopathies Premarital Screening [antibody; HIV-1 and HIV-2, single assay] or [Hepatitis B surface antigen (HBsAg)] or [Hepatitis C antibody] or [Syphilis test; EIA or qualitative non-treponemal (RPR)] Consent form for Rubella Vaccination Abbreviation list CDS DHA DPSC EIA HAAD HBsAg HBV HCV HIV HPLC HPV IEF IgG LOINC N/A N OH R RPR Communicable Disease Section Dubai Health Authority Government of Dubai Disease Prevention & Screening Center Enzyme Immunoassay Health Authority Abu Dhabi Hepatitis B Surface Antigen Hepatitis B virus Hepatitis C virus Human Immunodeficiency Virus High Pressure Liquid Chromatography Human papilloma virus Isoelectric Focusing Immunoglobulin G Logical Observation Identifiers Names and Codes andatory (when inserted to the left of a easurable Element) et (when inserted to the right of a easurable Element) Not applicable Not met (when inserted to the right of a easurable Element) inistry of Health easles, umps, Rubella Rapid Plasma Reagin - 3 -

5 SEHA TAT Abu Dhabi Health Service Company Turnaround Time - 4 -

6 PREARITAL SCREENING AND COUNSELING PROGRA INTRODUCTION UAE Personal Status Act No. 28, Article 27, issued in June 2005, edicts that a compulsory premarital medical screening report has to be obtained by couples who are planning to marry in UAE. The inistry of Health has issued executive decrees to this Act. Working within this context, Health Authority of Abu Dhabi is setting procedural standards for the premarital health screening required for issuing a Premarital Screening Report in the Emirate of Abu Dhabi similar to those applied elsewhere in the UAE. These standards are extensions to existing HAAD Standards and Policies for Ambulatory Care, Health Facilities licensing and Laboratories in the Emirate of Abu Dhabi. The premarital health screening program serves several purposes: 1. To ensure couples receive effective health counseling and appropriate advice before marriage. 2. To diagnose previously undetected medical, communicable and hereditary conditions in individual cases. 3. To protect the community and the unborn children from the financial, physical and psychological burden associated with several communicable and hereditary conditions. 4. To provide counseling which might alleviates anxiety especially if there is a family history of certain genetic diseases or consanguinity. Reaching these purposes requires a clinical and diagnostic service with high sensitivity, specificity and accuracy, completed within a limited turnaround time and with the highest integrity. These standards emphasize the need for high quality health screening processes which must be met by any health care facility licensed to perform the Premarital Screening and Counseling Program. They will be enforced in all places where the program is implemented in the Emirate of Abu Dhabi. Staff members dealing with couples planning for marriage, as per their function, are primarily responsible for following these standards. The overall accountability for implementation of these standards is the organization and/or the institution s head

7 PREARITAL HEALTH SCREENING (PS) STANDARDS ANUAL # STANDARD AND SCORING REQUIRENTS N N/A Premarital Counseling and Health Screening Roles and Responsibilities PS.1 Roles and responsibilities for Premarital Screening Providers and HAAD CDS are specified and followed 1. HAAD CDS will a. Develop Standards for the Premarital Health Screening of couples planning to marry in the Emirate of Abu Dhabi, following UAE law and OH decrees. b. Provide guidance, recommendations and training for the implementation of the standards. c. Authorize HAAD currently Licensed facilities to perform the Premarital Screening and Counseling Program. d. Supervise the premarital screening process through the information reported from the providers via HAAD web portal and through direct inspections. e. Authorize the release of Premarital Screening Reports. f. Receive notification of all diagnosed conditions. g. Receive notification of reactive communicable disease cases and the results of the subsequent confirmatory tests. 2. Premarital Screening Providers will a. Perform proper counseling, screening investigations, transfer specimens for confirmation as applicable and following HAAD Standards, and perform confirmatory investigations as authorized. b. Inform HAAD CDS of individual observations following format and turnaround times as specified for each activity. c. Follow code standards as specified for HAAD web portal for all data exchange and report to HAAD CDS. Premarital Screening: Overall Process PS.2 The process follows what is outlined in Premarital Screening Flowchart (Appendix 1) and Premarital Screening and Counseling Program with - 6 -

8 # STANDARD AND SCORING REQUIRENTS N N/A Frequently Asked Questions (Appendix 2a, and Appendix 2b) easurable Elements: PS.3 PS.4 PS.5 PS.6 1. The process follows what is outlined in the Premarital Screening Flowchart and the Premarital Screening and Counseling Program with Frequently Asked Questions. The Premarital Screening Program is only performed in facilities licensed for this activity by HAAD, OH or DHA. easurable Elements: 1. Premarital Screening Program is only performed in facilities licensed for this activity by HAAD. All couples planning to marry are included in the health screening easurable Elements: 1. All couples planning to marry are included in the health screening. All individuals are uniquely identified easurable Elements: 1. Unique identifiers based on Nationality and Passport number/unified number or Emirates ID and complying with HAAD protocol are used for all individuals. Documents required from Applicants applying for premarital screening 1. The original emirates I.D card if applicant is resident in U,A.E 2. A copy of passport OR identity card colored standard passport size photos (4.5 cm X 3.5 cm) showing the full face. 4. If applicant is below 18 years old, a parent must be present. PS.7 edical Content of the Premarital Screening Premarital screening comprises medical history and examination, laboratory testing and counseling as outlined below easurable Elements: 1. edical history, physical examination, counseling and laboratory investigations covering the most common haemoglobinopathies, and infectious diseases, as appropriate, is included as outlined in Premarital Screening & Counseling Form (Appendix 3), and Flowchart (Appendix 1). a.couples with a family history of haemoglobinopathy or any other genetic disease are referred to genetic specialist in your region for further evaluation (Appendix 4)

9 # STANDARD AND SCORING REQUIRENTS N N/A a.advice couples on healthy life style and recommend female to take folic acid prior pregnancy. 2. The delivered screening service corresponds to activities as outlined in Appendix Screening to detect haemoglobinopathies is included. PS.8 4. Screening to identify AB0 and Rh (D) blood type is included. 5. Screening to detect HIV is included. 6. Screening to detect hepatitis B is included. 7. Screening to detect hepatitis C is included. 8. Screening to detect syphilis is included. 9. Screening to identify rubella immunity of females is included. 10.Screening to detect sexually transmitted diseases (other than Syphilis; HIV and HBV) is included e.g. Gonorrhea and Chlamydia as indicated by history. 11.Confirmatory testing (as applicable) for above mentioned tests is included. 12.Vaccination of eligible females for rubella is included. 13.Vaccination of eligible partners for hepatitis B is included. 14. Vaccination for eligible females for Human Papilloma Virus included Registration, Records, Reports & Notifications All individual observations (i.e. clinical findings, negative, reactive, repeatedly reactive and confirmed laboratory tests) are sent to HAAD via web portal easurable Elements: 1. All individual observations are sent to HAAD via the web portal as specified for each activity in this standard. PS.9 Registration and record keeping, issuing of reports and notifications apply to the following general instructions easurable Elements: 1. Premarital Screening facilities treat all information of couples with high confidentiality. 2. Individuals below 18 years of age, who plan to marry, are accompanied by their parent(s) to the premarital screening facility. 3. Each individual of the couple signs a Premarital edical Examination Agreement (For Applicant) form (Appendix 6) 4. The signed Premarital Examination Agreement (For Applicant), (Appendix 6), premarital Screening & Counseling Form (Appendix 3), and Laboratory Results are kept in the individual s record at the premarital screening facility. 5. All premarital risk assessment information given to the couple - 8 -

10 # STANDARD AND SCORING REQUIRENTS N N/A follows the guidelines for premarital risk assessment in Appendix 7a & b, the risk assessment information is recorded in Arabic for judicial department in the Premarital Screening & Counseling Report (Appendix 8). 6. A Premarital Screening & Counseling Report (Appendix 8) is issued for each individual of the couple,, if all test results are normal and after the results have been discussed in the presence of both partners or individually ; and the two individuals sign the report as applicable. a. The Premarital Screening & Counseling Report is authorized by HAAD, and issued and signed by physician at the licensed Premarital Screening Facility. b. The signing doctor takes the responsibility of counseling and controlling the release of the certificate. c. The report is only valid for the partners mentioned on the report, and together with the report of the second partner, to complete the marriage process. d. The partner can delegate a relative or the other partner to pick up the medical certificate only if the results of the premarital screening tests are normal and if the Partner signed the agreement delegation form in Appendix 9. e. The delegate who will collect the certificate will sign that he or she received the certificate on the copy of the certificate not the original one. The copy of the certificate is kept with other patient documents for reference. f. The report is valid only for three months from the date of issue. g. If the applicant want to issue another premarital certificate after the end of the three months then only the infectious disease tests should be repeated and there is no need to repeat the blood genetic tests or the blood grouping 7. When a disease or carrier state is diagnosed, and after agreement of the affected individual, both of the couple are informed together/ or individually about the treatment possibilities and risk for transmission to a new generation. This is documented by the couple signing the Premarital Screening and Counseling Report concerned part (Appendix 8). Both Couples must sign the certificate. 8. a. If one of the couple refused to share the information about the disease or refused to sign the certificate then the certificate should not be issued and this must be recorded in the system. b. It is the responsibility of the attending doctor to document that and stop the release of the certificate c. The individual must sign a declaration of informed consent - 9 -

11 # STANDARD AND SCORING REQUIRENTS N N/A when he or she is informed with their test results. See Appendix 10. The responsibility of the physician signing the final certificate to ensure that both couples are aware about the disease and its consequences PS 10 before he issues the certificate. a. One copy of Appendix 8 [Premarital Screening and Counseling Report)] should be taken to the Judicial Department and the 2 nd copy to be kept in the record. b. Web based portal program with defined variables are filled online and sent to HAAD communicable disease section. Individuals marrying outside the country of UAE Single report certificate will be issued for those who are planning to marry outside the country of UAE.( see Appendix 11 Single report is issued only for those whom are planning to marry outside the country of UAE. The Certificate used for issuing is shown in Appendix-11 Program Package Price, Service Activities PS.11 Each partner of the couple applying for the Premarital Screening carries the cost as per Cabinet Decision easurable Elements: 1. Payment for screening services for the premarital screening must be made as follows: a. UAE Nationals must be covered by the Thiqa Health Insurance scheme b. Non-Nationals, unless Premarital Screening is explicitly stated as a covered benefit in an insurance plan, the cost of Premarital Screening must be covered by the individual requiring the service at cash-rates, and in accordance with HAAD requirements in this regard. c. Billing codes for Premarital Screening Services are available through Providers must Report and submit e-claims data in accordance with the Data anagement Policy, Chapter VI, Healthcare Regulator anual Version 1.0 and as set out in the HAAD Data Standards and Procedures. d. Charges for Premarital Screening services will be in accordance with the Standard Provider Contract negotiated rates, and in compliance with andatory Tariff pricelist and HAAD Claims and Adjudication Rules

12 # STANDARD AND SCORING REQUIRENTS N N/A General Requirements for Clinical Laboratory Services PS.12 The laboratory follows General Clinical Laboratory Standards easurable Elements: 1. A laboratory safety program is in place, complied with, and documented. 2. Individuals with adequate training skills, orientation, and experience administer the tests and interpret the results. 3. All equipment used for laboratory testing is regularly inspected, maintained, and calibrated, and appropriate records are maintained for these activities. 4. Essential reagents and other supplies are regularly available and used by the laboratory as appropriate. 5. Procedures for collecting, identifying, handling, safely transporting and disposing of specimens are complied with. 6. Established norms and ranges are used to interpret and report clinical laboratory results. 7. A qualified individual(s) is responsible for managing the clinical laboratory services or pathology service. 8. Quality control processes are in place, complied with, and documented, and a process for proficiency testing is maintained. 9. The laboratory has access to experts in specialized diagnostic areas as required. Quality Control and Risk Analysis PS.13 Quality Control shall cover all areas of the laboratory processes, follow international guidelines and focus on risk prone activities easurable Elements: 1. Risk prone activities have been identified and listed and are monitored regularly. 2. Positive and negative controls are included with each run as applicable for each test and as specified in each individual protocol for each separate analytical platform and reagent. 3. Proficiency testing is implemented for all tested parameters. Screening to Detect Haemoglobinopathies PS.14 Screening is performed with appropriate techniques to detect markers for haemoglobinopathies

13 # STANDARD AND SCORING REQUIRENTS N N/A easurable Elements: PS Premarital Screening for Carrier Identification of Haemoglobinopathies is implemented as outlined in Appendix 12. a. A Complete Blood Count (CBC) with all red cell indices is included. b. An initial screening of haemoglobin using HPLC or IEF is included. i. A confirmatory testing is performed of all results where abnormal haemoglobin is detected, on the original blood sample using a different technique from the screening test. 2. Interpretation and Reporting formats follow those outlined in Appendix 12. Screening to Identify AB0 and Rh(D) Blood Group Screening is performed with appropriate techniques to identify AB0 and Rh(D) blood groups easurable Elements: 1. AB0 and Rh (D) blood grouping is performed following AABB guidelines and as described in AABB Technical anual 15th Edition. a. Both forward and reverse grouping is performed. b. Grouping is performed by micro card technique using monoclonal antibodies (Diamed, Ortho etc). Screening to detect HIV, Hepatitis B, Hepatitis C and Syphilis PS.16 Screening is performed with appropriate techniques to detect markers for HIV, hepatitis B, hepatitis C and syphilis easurable Elements: 1. The process follows that outlined in Appendix 13, Premarital Screening: [Antibody; HIV-1 and HIV-2, single assay] or [Hepatitis B surface antigen (HBsAg)] or [Hepatitis C antibody] or [Syphilis test; EIA or qualitative non-treponemal (RPR)]. 2. The screening technique for HIV detects antibody; HIV-1 and HIV-2 in a single assay. 3. The screening technique for hepatitis B detects Hepatitis B surface antigen (HBsAg). 4. The screening technique for hepatitis C detects Hepatitis C antibody

14 # STANDARD AND SCORING REQUIRENTS N N/A 5. The screening technique for syphilis detects antibodies to Treponema pallidum, or consists of the qualitative nontreponemal rapid plasma reagin test (RPR). 6. The LOINC code and Brand Name for each technique is communicated to HAAD. 7. A new LOINC code and Brand Name is communicated to HAAD if the technique is changed. 8. All Not reactive results are sent as Negative to HAAD via web portal and within 24 hours. 9. When the outcome of the first analysis of a specimen is Reactive, Not reactive, Equivocal (Border line) or Not valid, the further testing follows that outlined in Appendix The testing process starts again from the beginning if an error causing a Not valid result is found and can be corrected; otherwise a new specimen is collected and the process starts from the beginning. 11.All Reactive / Equivocal tests are repeated in duplicate with the same specimen, the same technique and the same equipment as was used for the first analysis. 12.Specimens that are Not repeatedly reactive / Not repeatedly equivocal are reported as Negative to HAAD via web portal and within 24 hours. 13.The applicant is called for a second phlebotomy if the first specimen is Repeatedly reactive / Repeatedly equivocal for a marker of HIV, Hepatitis B, Hepatitis C or Syphilis. a. Both the first Repeatedly reactive / Repeatedly equivocal specimen and the second untested specimen are securely transported to a HAAD advised confirmatory laboratory for confirmatory testing. b. A hard copy of all relevant information and results of the screening tests sent together with the specimens for confirmatory testing. 14.All results of the confirmatory testing are sent to the premarital screening facility and to the HAAD web portal within 24 hours of completion. 15.There is a log identifying details of all specimens with a single Reactive, Equivocal or Not valid outcome. Turnaround Time for Screening to Detect Haemoglobinopathies, Blood group AB0 and Rh (D), HIV, Hepatitis B, Hepatitis C and Syphilis, Rubella immunity and Hepatitis B immunity. PS.17 Forwarding, processing, analyses and reporting of laboratory tests shall be organized for optimal short turnaround time easurable Elements: 1. Laboratory analyses shall start within 24 hours of an applicant s attendance at a clinic for all specimens for Premarital Screening

15 # STANDARD AND SCORING REQUIRENTS N N/A Tests. 2. CBC shall be performed on blood within 24 hours after phlebotomy. 3. Haemoglobinopathy screening and confirmatory testing of abnormal haemoglobin by a second method, interpretation and reporting following that outlined in Appendix 12 shall have a turnaround time within the laboratory of not more than three working days for >90% of cases. 4. Screening and retesting reactive specimens in duplicate shall have a turnaround time within the laboratory of not more than two working days. 5. A new specimen is taken within two working days, when a new specimen is required due to the outcome of a duplicate repeat testing of the first specimen. 6. The first repeatedly reactive specimen and the new specimen are forwarded, together with required specified information, to a confirmatory laboratory within 24 hours. 7. The outcomes of the screening, and repeat testing when needed, are sent to HAAD web portal within 24 hours. 8. The process is coordinated so >90% of all laboratory test results are delivered to the requesting Premarital screening centre not more than 7 working days after phlebotomy. 9. Each Premarital screening centre monitors turnaround times for their laboratory test results. Storage and Forwarding of Specimens for Confirmatory Testing PS.18 Storage and forwarding of specimens for confirmatory testing are optimized for security for fraud, physical and chemical changes and follow international rules for transportation of infectious substances. easurable Elements: 1. Specimens are stored refrigerated or frozen as applicable. 2. All transportation for confirmatory testing planned and the system is secured so only authorized persons can access the specimens. 3. Specimens are transported on ice in a cool box, but not frozen. 4. A triple container is used for specimens with suspected infectious substances as applicable. 5. Transportation schedules are harmonized with the confirmatory laboratory to minimize turnaround time. Screening for Immunity to Rubella

16 # STANDARD AND SCORING REQUIRENTS N N/A PS.19 All female applicants are controlled for immunity to rubella easurable Elements: PS The rubella IgG titer is requested for all female applicants. 2. The rubella IgG level is expressed and documented in IU/mL. a. Rubella IgG levels <10 IU/mL are interpreted as Negative or No protective immunity. b. Rubella IgG levels IU/mL are interpreted as Equivocal. c. Rubella IgG levels >15 IU/ml are interpreted as Protective immunity. 3. Women where the Rubella IgG level is interpreted as No protective immunity or Equivocal are counseled and offered Rubella or R vaccine, and given advice to avoid pregnancy for one month after vaccination. 4. The couple is counseled and asked to sign a consent form that they have been informed and advised to avoid pregnancy for one month following vaccination. Vaccination for Rubella Non-immune female applicants are vaccinated for rubella easurable Elements: 1. No written document indicates Rubella vaccine was given in the past. 2. Women with rubella IgG levels less than 15 IU/mL are offered rubella vaccination. 3. Only women eligible for rubella vaccination, with no contraindications and in line with HAAD vaccine standards are vaccinated. 4. Advice is given, prior to vaccination, to avoid pregnancy for one month. Rubella vaccination consent is signed by the female patient who will receive the vaccination and in the presence of witness, Use the form in Appendix The rubella vaccine is given as one dose of 0.5 ml Rubella or 0.5 ml R vaccine as an intramuscular or subcutaneous injection. 6. Vaccination for Hepatitis B PS.21 PS.22 Individuals are given a full vaccination series of Hepatitis B vaccine if they have been not vaccinated before. Individuals, whose partner is HBsAg positive, are given a booster dose

17 # STANDARD AND SCORING REQUIRENTS N N/A of hepatitis B vaccine if they have been vaccinated before, and a full vaccination series if they have not been vaccinated before. Their immunity is measured after vaccination. Individuals, whose partner is HBsAg positive, are offered a full Hepatitis B vaccine series of three doses if they have not been vaccinated before. 1. Each dose is given with 1.0 ml vaccine as an intramuscular injection. a. The second hepatitis B vaccine dose is given one month after the first dose. b. The third hepatitis B vaccine dose is given six month after the first dose. c. Individuals, whose partner is HBsAg positive, are offered a Hepatitis B vaccine booster dose if they have been vaccinated before. 2. The dose is given with 1.0 ml vaccine as an intramuscular injection. a. Only a partner eligible for hepatitis B vaccination and with no contraindications and in line with HAAD vaccine standards is vaccinated. 3. Anti HBs is controlled four weeks after the third dose of the full vaccine series or four weeks after the booster dose. PS Individuals with anti HBs >10 miu/ml are regarded as immune. 5. Individuals with anti HBs less than 10 miu/ml are given a new full primary vaccination series. 6. Anti HBs is controlled 1 month after the third dose. a. Non-responders with anti HBs less than 10 miu/ml are referred to an infectious diseases specialist for individual advice. Vaccination for Human Papilloma virus UAE national Female individuals, years of age, are given full vaccination series of HPV vaccine if they don t have documented history of receiving HPV vaccine before easurable Elements: 1. No written document indicates HPV vaccine was given in the past or who have not completed the 3-dose series Only women eligible for HPV vaccination, with no contraindications and in line with Thiqa Preventive List and HAAD vaccine standards are vaccinated. HAAD Standard for Childhood and Young adult Immunization Version 0.9 Reference HAAD/CHI/SD/0.9. Available on HAAD website d&tabid=

18 # STANDARD AND SCORING REQUIRENTS N N/A 2. If the women reaches age 26 years before the vaccination series is complete, remaining doses can be administered after age 26 years 3. HPV vaccination is given as three doses. Each dose is 0.5 ml, administered intramuscularly, preferably in a deltoid muscle. 4. Use recommended routine dosing intervals for series catchup (i.e., the second and third doses must be administered at 1 to 2 and 6 months after the first dose). The minimum interval between the first and second doses is 4 weeks. The minimum interval between the second and third doses is 12 weeks, and the third dose must be administered at least 24 weeks after the first dose. 5. If the HPV vaccine schedule is interrupted, the vaccine series does not need to be restarted. If a woman is found to be pregnant after initiating the vaccination series, the remainder of the 3-dose series should be delayed until completion of pregnancy 6. The doctor providing the counseling to the couples need to inform them of the importance of HPV vaccination in helping preventing against cervical cancer. They need to fully explain the aim of this vaccination and provide a leaflet on HPV vaccination to the female who will receive the vaccine Non-national female individuals aged are given advice regarding the importance of HPV vaccination If Non-national female is eligible for the HPV according to the above measurements mentioned in PS 21 she is entitled to receive the HPV vaccination according to her insurance embracement plans and the HAAD standards regulations for the HPV vaccine References 1. Clinical and Laboratory Standards Institute. Laboratory Detection and Quantitation of rubella IgG Antibody: Evaluation and Performance Criteria for ultiple Component Test Products, Specimen Handling, and Use of Test Products in the Clinical Laboratory; CLSI I/LA6-A. 2. WHO. Comparison of rubella seroepidemiology in 17 countries: towards international disease control targets. Available at: