Annex 6 Investigation Report Forms - WHO
Annex 6Investigation report formsOutline of an outbreak investigation reportCover page Title of reportIndicate whether this is a preliminary or a final report. Keep the title short andmemorable, but include information on the type of problem under investigation, thelocation and date. Date of report Names and affiliations of the main authors and investigatorsAbstractThe abstract should be written after the report has been completed. It should stand alone andcontain the most relevant data and conclusions. All data mentioned in the abstract must alsoappear in the main section of the report. Sentences from the Discussion section can be usedverbatim in the abstract.Report IntroductionStatement of the problem and its public health importance.Details and time frame regarding initial source of information.Reasons for investigating event.Type of investigations conducted and agencies involved. BackgroundGenerally available information to help the reader interpret epidemiology and datapresented in the report (e.g. population size, socioeconomic status of community,ethnicity, etc.).If outbreak occurred in a food premises, description of premises (e.g. size of restaurant,usual practices and operations, etc.).Description of the problem.Sequence of events leading to the study or investigation.Brief statement of the working hypothesis. ObjectivesSpecify targets to be achieved by the investigations.Keep objectives concise and follow a logical, sequential pattern.The objectives may include hypotheses, if any, to be tested.114Foodborne Disease Outbreaks: Guidelines for Investigation and Control
MethodsEpidemiology:––––––description of study populationtype of study conductedcase definitionprocedures for case-ascertainment and selection of controls (if any)methods of data collection, including questionnaire design, administration andcontentsmethods of data analysis.Medical laboratory testing:–––methods of specimen collection and processingname of laboratory carrying out testslaboratory techniques employed and methods of data analysis.Food and food testing:–––– description of inspection processmethods of food and environmental samplingname of laboratory carrying out testslaboratory techniques employed and methods of data analysis.ResultsPresent all pertinent results from clinical, laboratory, epidemiological and environmentalfindings.Present results in same order as described in the methods section.Do not interpret or discuss the data in this section.Epidemiology:–––––number of cases, overall attack rateclinical details of illness (symptoms, duration, hospitalization, outcome, etc.)descriptive epidemiology by time (epidemic curve), place and person (age, sex, race,specific characteristics) expressed as ratesrisk factor exposuresfurther data analysis and data presentation depending on specific studies undertaken(e.g. cohort or case–control study).Laboratory (microbiology, chemical, toxicological):––number of specimens collectedfindings by type of laboratory analysis.Food investigation and food testing:–– findings of food inspectionsresults of laboratory tests performed on food and environmental samples.DiscussionThe discussion is the most important part of the report and should cover:––summary of the major findingslikely accuracy of the resultsFoodborne Disease Outbreaks. Guidelines for Investigation and Control115
––––– conclusions with justification for those conclusion and rejection of alternativeexplanationsrelationship of these results to other studies and the literatureimplications of the findingsan assessment of control measuresneeds for future research.RecommendationsInitial recommendations and those for future prevention and control should be listednumerically. ReferencesSelect appropriate references, including reviews in major scientific journals. Follow astandard style of referencing (e.g. Vancouver style), numbering the references in the orderin which they appear in the text. AppendicesQuestionnaires and/or other survey formsAppropriate field reportsAny other relevant documents, including press releases.116Foodborne Disease Outbreaks: Guidelines for Investigation and Control
Sample report forms from various agenciesExample of an outbreak report form used by the WHO SurveillanceProgramme for Control of Foodborne Infections and Intoxications inEuropeReport of incident1. Country:2. Year:3. Report no.:4. Place of incident:City/Town: Province/District:5. Causative agent/type:Code: F F F F F FPhagetype: F F FConfirmed: FPresumed: F6. Number of persons:at riskillhospitalizeddiedby age groups:from 0 to 4 yearsfrom 4 to 15 earsfrom 15 to 60 yearsover 60 years7. Symptoms:F NauseaF VomitingF DiarrhoeaF Abdominal painF FeverF NeurologicalF Cardiovascular F Other ( )8. Date of onset of illness:first person: / /daymonthlast person: / /yeardaymonthyear9. Incubation time and duration of illness: (in hours): F ?Incubation time:shortestlongestmedianDuration of illness: shortestlongestmedian10. Food/vehicle involved:Code: F F F F F FConfirmation:Laboratory FEpidemiological FCommercial name of product:Producer:11. Methods of marketing, processing, serving:Marketed: code FTreatment before final preparation: code FServed and eaten: code FFoodborne Disease Outbreaks. Guidelines for Investigation and Control117
12. Place where food was contaminated:Place: code FCountry: code F13. Place and date where food was acquired and eaten:Place: code FDate: / /daymonthyearDuring transit:Means of transit: code Ffrom: code Fto: code F14. Factors contributing to incident:(a) Code F F(b) Code F FOtherNote: In case more than one factor contributed, list all that are applicable but code only the two major factors.15. Results of lab. tests:Testing laboratory:Specimens/samplesNo. testedPositiveDetails/commentsIll people*Well people*Food-handlersSuspect foodOther foodsEnvironment* Clinical samples.118Foodborne Disease Outbreaks: Guidelines for Investigation and Control
Example of an outbreak form used in England and Wales forinvestigation of general outbreaks of infectious intestinal diseasesOUTBREAK :1. MODE OF TRANSMISSION (tick one only)Mainly person to person FMainly foodborne FEqual or unknown proportion of foodborne and person to person FOther F Specify water, animal contact, etc.Unknown F2. PLACE WHERE OUTBREAK OCCURRED, or if foodborne where food was preparedor served. Tick one only. If foodborne “PREPARED” takes precedence over “SERVED”,e.g. if food was prepared in a shop but served in a house, tick “Shop/retailer”, if food wasprepared at a house and served elsewhere, tick “Private house”.(a) Private houseF(b) House/guest house/residential pub F Specify(c) Restaurant/caféF Specify ethnicity(d) Pub/barF(e) Mobile retailerF Specify market trader, chip van, etc.(f) Armed services campF Specify army, navy, etc.(g) CanteenF Specify work, college(h) Shop/retailerF Specify baker, butcher, etc.(i) HospitalF Specify general, geriatric, EMI(j) Residential institutionF Specify nursing/residential home(k) SchoolF Specify nursery, junior, etc.(l) OtherF Specify3. NAME AND ADDRESS OF PLACEPostcode (if known)4. WAS THE OUTBREAK AT A FUNCTION? Yes F No F Date of function / /5. WAS PATHOGEN/TOXIN IDENTIFIED?Yes FNo FIf YES give: Organism/toxin Serotype Phage typeIf NO:Specify organism suspected6. LABORATORY where tests performed:microbiology was negativeFFirst labState first and reference labs, even ifFReference labFoodborne Disease Outbreaks. Guidelines for Investigation and Control119
7. TOTAL NUMBER AFFECTED (diarrhoea and/or vomiting /– any other symptom)TOTAL NUMBER AT RISKNumber admitted to hospitalNumber known to have died8. LABORATORY RESULTSAFFECTED PEOPLENUMBER OF PEOPLETESTEDPOSITIVEWELL PEOPLETESTEDPOSITIVE8a. HOSPITAL OR RESIDENTIAL OUTBREAKSONLY categories (i) and (j) in question 2Residential/patientsStaffTotal8b. ALL OTHER OUTBREAKSNon-food-handlersFood handlersTotal9. DATE OF ONSET:First known / /Last known / /10. SUSPECT FOOD VEHICLE ASSOCIATED WITH ILLNESS: only list specific vehicle forwhich there is microbiological, statistical or other convincing association with illness.EVIDENCE (tick)VEHICLEMicrobiologicalStatistical association11. FAULTS THOUGHT TO HAVE CONTRIBUTED TO OUTBREAK:Infected food-handlerF Give detailsInadequate heat treatmentF Give detailsCross contaminationF Give detailsStorage too long/too warmF Give detailsOtherF Give detailsEnvironmental Health Department’s inspection rating of premises (if available) (A–F):120Foodborne Disease Outbreaks: Guidelines for Investigation and Control
Foodborne disease outbreak report form from Centers for Disease Controland Prevention, USAInvestigation of a foodborne This form is used to report foodborne disease outbreak investigations to CDC. It isalso used to report Salmonella enteritidis and E. coli O157:H7 outbreakinvestigations involving any mode of transmission. A foodborne outbreak is definedas the occurrence of two or more cases of a similar illness resulting from theingestion of a common food in the United States. This form has 6 parts. Part 1asks for the minimum or basic information needed and must be completed for theinvestigation to be counted in the CDC annual summary. Part 2 asks for additionalinformation for any foodborne outbreak, while Parts 3–6 ask for informationconcerning specific vehicles or etiologies. Please complete as much of all parts aspossible.CDC Use Only-State Use OnlyPart 1: Basic information1. Report type3. Dates4. Location of exposureA.Please enter as many dates as possibleReporting statePlease check if this is a final reportDate first case became illB./ /Month Day YearPlease check if data does not supporta FOODBORNE outbreakDate last case became ill2. Number of cases/ /Month Day YearLab-confirmed cases (A)Including secondary casesReporting countyDate first known exposure/ /Month Day YearProbable cases (B)Including secondary casesDate last known exposureEstimated total ill(if greater than sum A B)5. Approximate percentage ofcases in each age group 1 year % 20–49 yrs %1–4 yrs % 50 yrs %5–19 yrs % Unknown %If multiple states involved:Exposure occurred in multiple statesExposure occurred in single state, butcases resided in multiple statesOther states:/ /Month Day YearIf multiple counties involved:Exposure occurred in multiple countiesExposure occurred in one county, butcases resided in multiple countiesOther counties:7. Investigation methods (check all that apply)6. Sex(estimated percentage ofthe total cases)Male%Female%Interviews of only casesFood preparation reviewInvestigation at factory orproduction plantInvestigation at original source(farm, marine estuary, etc.)Environment / food sample culturesFood product tracebackCase–control studyCohort study8. Implicated food(s) (please provide known information)Name of foode.g. lasagneMain ingredient(s)e.g. pasta, sauce, eggs, beefContaminated ingredient(s)e.g. eggsReason(s) suspected(see codes just below)e.g. 4Method of preparation(see attached codes)e.g. M11)2)3)Food vehicle undeterminedReason suspected (list above all that apply)1. Statistical evidence from epidemiological investigation2. Laboratory evidence (e.g. identification of agent in food)3. Compelling supportive information4. Other data (e.g. same phage type found on farm that supplied eggs)5. Specific evidence lacking but prior experience makes it likely sourceFoodborne Disease Outbreaks. Guidelines for Investigation and Control121
9. Etiology (Name the bacteria, virus, parasite, or toxin. If available, include the serotype and other characteristics such as phage type, virulencefactors, and metabolic profile. Confirmation criteria available at http//www.cdc.gov/ncidod/dbmd/outbreak/ or MMWR2000/Vol. 49/SS-1/App. B)EtiologyOther characteristics(e.g. phage cted in(see codes just below)Etiology undeterminedDetected in (list above all that apply)1. Patient specimen(s) 2. Food specimen(s)10. Isolate subtype3. Environment specimen(s)State Lab. ID4. Food worker specimen(s)PFGE (PulseNet designation)PFGE (PulseNet designation)1)2)3)11. Contributing factors (check all that apply: see attached codes and explanations)Contributing factors unknownContamination factorC1C2C3C4C5C6C7C8C9C10C11C12C13C14C15 (describe in Comments)P10P11P12 (describe in Comments)N/AProliferation/amplification factor (bacterial outbreaks only)P1P2P3P4P5P6P7P8P9N/ASurvival factor (microbial outbreaks only)S1S2S3S4S5 (describe in Comments)N/AWas food-worker implicated as the source of contamination? Yes NoIf yes, please check only one of following:laboratory and epidemiologic evidenceepidemiologic evidence (w/o lab confirmation)lab evidence (w/o epidemiologic evidence)prior experience makes this the likely source (please explain in Comments)Part 2: Additional information12. Symptoms, signs and outcomesFeatureHealthcare Bloody stoolsFeverAbdominal crampsHUS or TTPAsymptomatic***122Cases withoutcome/featureTotal cases for whomyou have informationavailable13. Incubation period14. Duration of Illness (among(circle appropriate units)those who recovered)(circle appropriate units)Shortest (hours, days)Longest (hours, days)Median (hours, days)UnknownShortest (hours, days)Longest (hours, days)Median (hours, days)Unknown* Use the following terms, if appropriate, to describe other commoncharacteristics of cases:AnaphylaxisHeadacheTachycardiaTemperature ombocytopeniaBullous skin yalgiaDescending re throatFoodborne Disease Outbreaks: Guidelines for Investigation and Control
15. If cohort investigation conducted:Attack rate* / x 100 %Exposed and illTotal number exposed for whom you have illness information* The attack rate is applied to persons in a cohort who were exposed to the implicated vehicle. The numerator is the number of persons who wereexposed and became ill; the denominator is the total number of persons exposed to the implicated vehicle. If the vehicle is unknown, then the attackrate should not be calculated.16. Location where food was prepared17. Location of exposure or where food was eaten(check all that apply)(check all that apply)Restaurant or deliNursing homeDay care centerPrison, jailSchoolPrivate homeOffice settingWorkplace, not cafeteriaWorkplace cafeteriaWedding receptionBanquet facilityChurch, temple, etc.PicnicCampCatererContaminated food imported into U.S.Grocery storeHospitalFair, festival, other temporary/ mobile servicesCommercial product, served without further preparationUnknown or undeterminedOther (describe)Restaurant or deliNursing homeDay care centerPrison, jailSchoolPrivate homeOffice settingWorkplace, not cafeteriaWorkplace cafeteriaWedding receptionBanquet facilityChurch, temple, etc.PicnicCampGrocery storeHospitalFair, festival, temporary/ mobile serviceUnknown or undeterminedOther (describe)18. Trace backPlease check if trace back conducted.Source to which trace back led:Source(e.g. chicken farm, tomato processing plant)StateLocation of sourceCounty19. RecallComments20. Available reports (please attach)Please check if any food product recalled.Recall commentsUnpublished agency reportEpi-Aid reportPublication (please reference if not attached)21. Agency reporting this outbreak22. RemarksBriefly describe important aspects of the outbreak not covered above(e.g. restaurant closure, immunoglobin administration, economic impact,etc.)Contact person:NameTitlePhoneFaxE-mailFoodborne Disease Outbreaks. Guidelines for Investigation and Control123
Part 3: School questions1. Did the outbreak involve a single or multiple schools?SingleMultiple (if yes, number of schools )2. School characteristics (for all involved students in all involved schools)a) Total approximate enrolment(number of students)Unknown or undeterminedb) Grade level(s) (please check all grades affected)PreschoolGrade school (grades K–12)Please check all grades affected: K1stCollege/university/technical schoolUnknown or undetermined2nd3rd4th5th6th7th8th9th10th11th12thc) Primary funding of involved school(s)PublicPrivateUnknown or undetermined3. Describe the preparation of the implicated item:Heat and serve (item mostly prepared or cooked off-site,reheated on-site)Served a-la-carteServe only (preheated or served cold)Cooked on-site using primary ingredientsProvided by a food service management companyProvided by a fast food vendorProvided by a pre-plate companyPart of a club/fundraising eventMade in the classroomBrought by a student/teacher/parentOtherUnknown or undetermined4. How many times has the state, county or local health departmentinspected this school cafeteria or kitchen in the 12 months beforethe outbreak?*OnceTwiceMore than two timesNot inspectedUnknown or undetermined*If there are multiple schools involved, please answer according to the mostaffected school.5. Does the school have a HACCP plan in place for the schoolfeeding program?*YesNoUnknown or undetermined*If there are multiple schools involved, please answer according to the mostaffected school.6. Was implicated food item provided to the school through the National School Lunch/Breakfast Program?YesNoUnknown or undeterminedIf Yes, was the implicated food item donated/purchased by :USDA through the Commodity Distribution ProgramPurchased commercially by the state/school authorityOtherUnknown or undetermined124Foodborne Disease Outbreaks: Guidelines for Investigation and Control
Part 4: Ground beef1. What percentage of ill persons (for whom information is available) ate ground beef raw or undercooked? %2. Was ground beef case-ready? (Ground beef that comes from a manufacturer packaged for sale and not altered or repackaged by the retailer)YesNoUnknown or undetermined3. Was the beef ground or reground by the retailer?YesNoUnknown or undeterminedIf yes, was anything added to the beef during grinding (e.g. shop trim or any product to alter the fat content)?Part 5: Mode of transmission(enterohaemorrhagic E. coli or Salmonella enteritidis only)1. Mode of transmission (for greater than 50% of cases)Select one:FoodPerson to personSwimming or recreational waterDrinking waterContact with animals or their environmentUnknown or undeterminedPart 6: Additional egg questions1. Were eggs (check all that apply):in-shell, un-pasteurized?in-shell, pasteurized?liquid or dry egg product?stored with inadequate refrigeration during or after sale?consumed raw?consumed undercooked?pooled?2. If eggs traced back to farm, was Salmonella enteritidis found on the farm?YesNoUnknown or undeterminedComment:Foodborne Disease Outbreaks. Guidelines for Investigation and Control125
Contamination factors:C1C2C3C4––––C5 –C6 –C7 –C8 –C9 –C10 –C11 –C12 –C13 –C14 –C15 –1Toxic substance part of tissue (e.g. ciguatera)Poisonous substance intentionally added (e.g. cyanide or phenolphthalein added to cause illness)Poisonous or physical substance accidentally/incidentally added (e.g. sanitizer or cleaning compound)Addition of excessive quantities of ingredients that are toxic under these situations (e.g. niacin poisoning inbread)Toxic container or pipelines (e.g. galvanized containers with acid food, copper pipe with carbonatedbeverages)Raw product/ingredient contaminated by pathogens from animal or environment (e.g. Salmonella enteriditis inegg, norovirus in shellfish, E. coli in sprouts)Ingestion of contaminated raw products (e.g. raw shellfish, produce, eggs)Obtaining foods from polluted sources (
– laboratory techniques employed and methods of data analysis. Food and food testing: – description of inspection process – methods of food and environmental sampling . C1 C2 C5 C3 C7 C4 C8 C9 C6 C10 C11 C12 C13 C14 C15 (describe in .
Annex 5: Response ECCO Annex 6: Response Gabor Annex 7: Response M&S Annex 8: Response PUMA Annex 9: Response Van Lier Annex 10: Response Primark Annex 11: Response MVO Nederland (CSR Netherlands) Annex 12: Response Leather Working Group . Child labour in the production of brand name leather shoes. in India." .
ICAO Annex 1 – Amdt.172 Annex 6 – Amdt.38 PANS-TRG – Amdt. 3 Doc 10011 02/2014 ICAO amendments to Annex 1, Annex 6 and PANS-TRG (Doc 9868) to a) Meet the UPRT requirements for an MPL, contained in Annex 1 b) Provide UPRT recommendations for a CPL(A), contained in Annex 1 c) Meet the requirements for type-rating, contained
Bills of Exchange Annex Equities Annex Gilts Annex Italian Annex Japanese Annex ** RITS Annex Abu Dhabi X X X X X X Australia X X X X X X X X Bahamas X X X X X X Bahrain X X X X X X Bermuda X X X X X X British Virgin Islands X X X X X X Cayman Islands X X X X X X . Section 730 of the UK Taxes Act
Annex 6 Operation of Aircraft Annex 7 Aircraft Nationality and Registration Marks Annex 8 Airworthiness of Aircraft Annex 9 Facilitation Annex 10 Aeronautical Telecommunications Annex 11 Air Traffic Services . Therefore, ICAO has implemented the
EU GMP Guide-Annex 15 Qualification & Validation draft released In February 2014, a draft of the revised Annex 15 was released by the European Commission (EC) for public comment. The draft version is based on an EMA Concept Paper, published in November 2012 which outlined various reasons for the revision of Annex 15.File Size: 553KBPage Count: 17Explore furtherEU GMP Annex 15: Qualification and Validation - ECA Acad www.gmp-compliance.orgEU GMP Annex 15 Revisions: Improving Qualification and .www.cleanroomtechnology.c GUIDELINES ON VALIDATION APPENDIX 6 VALIDATION O www.who.intGuideline on Process Validationwww.ema.europa.euEudraLex - Volume 4 - Good Manufacturing Practice (GMP .ec.europa.euRecommended to you b
According to NB-MED/2.2/Rec4. Conformity Assessment Procedures Annex III EC type-examination Annex IV EC verification Annex V production quality assurance Annex VI product quality assurance Annex VII EC declaration of conformity Annex II full quality assurance system xxxx Hardly
How PDF Forms Access Helps With Accessibility 13 Brief Review of PDF Forms 13 Exercise: PDF Form Field Properties 15 Summary 21 Adobe PDF Forms Access: Tagging PDF Forms 22 Introduction to PDF Forms Access 22 Overview of PDF Forms Access 24 Exercise: Initializing a Form Using PDF Forms Access 32 Modifying the PDF Forms Access Structure Tree 36
ANNEX B. PUBLIC CONSULTATION - SYNOPSIS REPORT . 19 ANNEX C. CATEGORISATION OF NATIONAL LEGAL FRAMEWORKS . 46 ANNEX D. OVERVIEW OF ADDITIONAL REQUIREMENTS. 53 ANNEX E. LIST OF REFERENCES . 57 ANNEX F. EVALUATION MATRIX . 60. Study on on the evaluation of the invoicing rules of Directive 2006/112/EC 5 Acronyms and Abbreviations AES Advanced Electronic Signature BCAT Business .
