Commission Implementing Decision of 8 August 2012 amending Decision 2002/253/EC laying down case definitions for reporting communicable diseases to the Community network under Decision No 2119/98/EC of the European Parliament and of the Council (notified under document C(2012) 5538) (Text with EEA relevance) (2012/506/EU) (c. 506)

1. Introductory Text

2. Article 1. The Annex to Decision 2002/253/EC is replaced by the Annex...

3. Article 2. This Decision is addressed to the Member States.

4. Signature

5. 1. ANNEX

      1. 1. EXPLANATION OF THE SECTIONS USED IN THE DEFINITION AND CLASSIFICATION...

         1. Clinical criteria

         2. Laboratory criteria

         3. Epidemiological criteria and epidemiological link

         4. Case classification

         5. Possible case

         6. Probable case

         7. Confirmed case

         8. Laboratory-confirmed case with clinical criteria

         9. Laboratory-confirmed case with unknown clinical criteria

         10. Laboratory-confirmed case without clinical criteria

      2. 2. CASE DEFINITIONS OF COMMUNICABLE DISEASES

         1. 2.1. ACQUIRED IMMUNODEFICIENCY SYNDROME (AIDS) AND HUMAN IMMUNODEFICIENCY VIRUS (HIV) INFECTION...

            1. Clinical Criteria (AIDS)

            2. Laboratory Criteria (HIV)

            3. Epidemiological Criteria NA

            4. Case Classification

               1. A. Possible case NA

               2. B. Probable case NA

               3. C. Confirmed case

         2. 2.2. ANTHRAX (Bacillus anthracis)

            1. Clinical Criteria

               1. Cutaneous anthrax

               2. Gastrointestinal anthrax

               3. Inhalational anthrax

               4. Meningeal/meningoencephalitic anthrax

               5. Anthrax septicaemia

            2. Laboratory Criteria

            3. Epidemiological Criteria

            4. Case Classification

               1. A. Possible case NA

               2. B. Probable case

               3. C. Confirmed case

         3. 2.3. AVIAN INFLUENZA A/H5 OR A/H5N1 IN HUMANS

            1. Clinical Criteria

            2. Laboratory Criteria

            3. Epidemiological Criteria

            4. Case Classification

               1. A. Possible case

               2. B. Probable case

               3. C. Nationally confirmed case

               4. D. WHO confirmed case

         4. 2.4. BOTULISM (Clostridium botulinum)

            1. Clinical Criteria

               1. Food-borne and wound botulism

               2. Infant botulism

            2. Laboratory Criteria

            3. Epidemiological Criteria

            4. Case Classification

               1. A. Possible case NA

               2. B. Probable case

               3. C. Confirmed case

         5. 2.5. BRUCELLOSIS (Brucella spp.)

            1. Clinical Criteria

            2. Laboratory Criteria

            3. Epidemiological Criteria

            4. Case Classification

               1. A. Possible case NA

               2. B. Probable case

               3. C. Confirmed case

         6. 2.6. CAMPYLOBACTERIOSIS (Campylobacter spp.)

            1. Clinical Criteria

            2. Laboratory Criteria

            3. Epidemiological Criteria

            4. Case Classification

               1. A. Possible case NA

               2. B. Probable case

               3. C. Confirmed case

         7. 2.7. CHLAMYDIAL INFECTION (Chlamydia trachomatis), INCLUDING LYMPHOGRANULOMA VENEREUM (LGV)

            1. Clinical Criteria

               1. Chlamydial infection non-LGV

               2. LGV

            2. Laboratory Criteria

               1. Chlamydial infection non-LGV

               2. LGV

            3. Epidemiological Criteria

            4. Case Classification

               1. A. Possible case NA

               2. B. Probable case

               3. C. Confirmed case

         8. 2.8. CHOLERA (Vibrio cholerae)

            1. Clinical Criteria

            2. Laboratory Criteria

            3. Epidemiological Criteria

            4. Case Classification

               1. A. Possible case NA

               2. B. Probable case

               3. C. Confirmed case

         9. 2.9. CREUTZFELDT-JAKOB DISEASE, VARIANT (vCJD)

            1. Preconditions

            2. Clinical Criteria

            3. Diagnostic Criteria

               1. Diagnostic criteria for case confirmation:

               2. Diagnostic criteria for a probable or a possible case:

            4. Epidemiological Criteria

            5. Case Classification

               1. A. Possible case

               2. B. Probable case

               3. C. Confirmed case

         10. 2.10. CRYPTOSPORIDIOSIS (Cryptosporidium spp.)

             1. Clinical Criteria

             2. Laboratory Criteria

             3. Epidemiological Criteria

             4. Case Classification

                1. A. Possible case NA

                2. B. Probable case

                3. C. Confirmed case

         11. 2.11. DIPHTHERIA (Corynebacterium diphtheriae, Corynebacterium ulcerans and Corynebacterium pseudotuberculosis)

             1. Clinical Criteria

                1. Classic Respiratory Diphtheria:

                2. Mild Respiratory Diphtheria:

                3. Cutaneous Diphtheria:

                4. Diphtheria of other sites:

             2. Laboratory Criteria

             3. Epidemiological Criteria

             4. Case Classification

                1. A. Possible case

                2. B. Probable case

                3. C. Confirmed case

         12. 2.12. ECHINOCOCCOSIS (Echinococcus spp.)

             1. Clinical Criteria

             2. Diagnostic Criteria

             3. Epidemiological Criteria NA

             4. Case Classification

                1. A. Possible case NA

                2. B. Probable case NA

                3. C. Confirmed case

         13. 2.13. GIARDIASIS (Giardia lamblia)

             1. Clinical Criteria

             2. Laboratory Criteria

             3. Epidemiological Criteria

             4. Case Classification

                1. A. Possible case NA

                2. B. Probable case

                3. C. Confirmed case

         14. 2.14. GONORRHOEA (Neisseria gonorrhoeae)

             1. Clinical Criteria

             2. Laboratory Criteria

             3. Epidemiological Criteria

             4. Case Classification

                1. A. Possible case NA

                2. B. Probable case

                3. C. Confirmed case

         15. 2.15. HAEMOPHILUS INFLUENZAE, INVASIVE DISEASE (Haemophilus influenzae)

             1. Clinical Criteria

             2. Laboratory Criteria

             3. Epidemiological Criteria NA

             4. Case Classification

                1. A. Possible case NA

                2. B. Probable case NA

                3. C. Confirmed case

         16. 2.16. HEPATITIS A (Hepatitis A virus)

             1. Clinical Criteria

             2. Laboratory Criteria

             3. Epidemiological Criteria

             4. Case Classification

                1. A. Possible case NA

                2. B. Probable case

                3. C. Confirmed case

         17. 2.17. HEPATITIS B (Hepatitis B virus)

             1. Clinical Criteria

             2. Laboratory Criteria

             3. Epidemiological Criteria

             4. Case Classification

                1. A. Possible case NA

                2. B. Probable case NA

                3. C. Confirmed case

         18. 2.18. HEPATITIS C (Hepatitis C virus)

             1. Clinical Criteria

             2. Laboratory Criteria

             3. Epidemiological Criteria NA

             4. Case Classification

                1. A. Possible case NA

                2. B. Probable case NA

                3. C. Confirmed case

         19. 2.19. INFLUENZA (Influenza virus)

             1. Clinical Criteria

                1. Influenza-like illness (ILI)

                2. Acute respiratory infection (ARI)

             2. Laboratory Criteria

             3. Epidemiological Criteria

             4. Case Classification

                1. A. Possible case

                2. B. Probable case

                3. C. Confirmed case

         20. 2.20. INFLUENZA A(H1N1)

             1. Clinical criteria

             2. Laboratory criteria

             3. Epidemiological criteria

             4. Case classification

                1. A. Case under investigation

                2. B. Probable case

                3. C. Confirmed case

         21. 2.21. LEGIONNAIRES’ DISEASE (Legionella spp.)

             1. Clinical Criteria

             2. Laboratory Criteria

             3. Epidemiological Criteria NA

             4. Case Classification

                1. A. Possible case NA

                2. B. Probable case

                3. C. Confirmed case

         22. 2.22. LEPTOSPIROSIS (Leptospira spp.)

             1. Clinical Criteria

             2. Laboratory Criteria

             3. Epidemiological Criteria

             4. Case Classification

                1. A. Possible case NA

                2. B. Probable case

                3. C. Confirmed case

         23. 2.23. LISTERIOSIS (Listeria monocytogenes)

             1. Clinical Criteria

             2. Laboratory Criteria

             3. Epidemiological Criteria

             4. Additional information

             5. Case Classification

                1. A. Possible case NA

                2. B. Probable case

                3. C. Confirmed case

         24. 2.24. MALARIA (Plasmodium spp.)

             1. Clinical Criteria

             2. Laboratory Criteria

             3. Epidemiological Criteria NA

             4. Case Classification

                1. A. Possible case NA

                2. B. Probable case NA

                3. C. Confirmed case

         25. 2.25. MEASLES (Measles virus)

             1. Clinical Criteria

             2. Laboratory Criteria

             3. Epidemiological criteria

             4. Case Classification

                1. A. Possible case

                2. B. Probable case

                3. C. Confirmed case

         26. 2.26. MENINGOCCOCAL DISEASE, INVASIVE (Neisseria meningitidis)

             1. Clinical Criteria

             2. Laboratory Criteria

             3. Epidemiological Criteria

             4. Case Classification

                1. A. Possible case

                2. B. Probable case

                3. C. Confirmed case

         27. 2.27. MUMPS (Mumps virus)

             1. Clinical Criteria

             2. Laboratory Criteria

             3. Epidemiological Criteria

             4. Case Classification

                1. A. Possible case

                2. B. Probable case

                3. C. Confirmed case

         28. 2.28. PERTUSSIS (Bordetella pertussis)

             1. Clinical Criteria

             2. Laboratory Criteria

             3. Epidemiological Criteria

             4. Case Classification

                1. A. Possible case

                2. B. Probable case

                3. C. Confirmed case

         29. 2.29. PLAGUE (Yersinia pestis)

             1. Clinical Criteria

                1. Bubonic plague:

                2. Septicaemic plague:

                3. Pneumonic plague:

             2. Laboratory Criteria

             3. Epidemiological Criteria

             4. Case Classification

                1. A. Possible case NA

                2. B. Probable case

                3. C. Confirmed case

         30. 2.30. PNEUMOCOCCAL INVASIVE DISEASE(S) (Streptococcus pneumoniae)

             1. Clinical Criteria

             2. Laboratory Criteria

             3. Epidemiological Criteria NA

             4. Case Classification

                1. A. Possible case NA

                2. B. Probable case NA

                3. C. Confirmed case

         31. 2.31. POLIOMYELITIS (Polio virus)

             1. Clinical Criteria

             2. Laboratory Criteria

             3. Epidemiological Criteria

             4. Case Classification

                1. A. Possible case

                2. B. Probable case

                3. C. Confirmed case

         32. 2.32. Q FEVER (Coxiella burnetii)

             1. Clinical Criteria

             2. Laboratory Criteria

             3. Epidemiological Criteria

             4. Case Classification

                1. A. Possible case NA

                2. B. Probable case

                3. C. Confirmed case

         33. 2.33. RABIES (Lyssa virus)

             1. Clinical Criteria

             2. Laboratory Criteria

             3. Epidemiological Criteria

             4. Case Classification

                1. A. Possible case

                2. B. Probable case

                3. C. Confirmed case

         34. 2.34. RUBELLA (Rubella virus)

             1. Clinical Criteria

             2. Laboratory Criteria

             3. Epidemiological Criteria

             4. Case Classification

                1. A. Possible case

                2. B. Probable case

                3. C. Confirmed case

         35. 2.35. RUBELLA, CONGENITAL (Including Congenital Rubella Syndrome)

             1. Clinical Criteria

                1. Congenital rubella infection (CRI)

                2. Congenital rubella syndrome (CRS)

                   1. (A)

                   2. (B)

             2. Laboratory Criteria

             3. Epidemiological Criteria

             4. Case Classification Congenital Rubella

                1. A. Possible case NA

                2. B. Probable case

                3. C. Confirmed case

         36. 2.36. SALMONELLOSIS (Salmonella spp. other than Salmonella typhi and Salmonella paratyphi)...

             1. Clinical Criteria

             2. Laboratory Criteria

             3. Epidemiological Criteria

             4. Case Classification

                1. A. Possible case NA

                2. B. Probable case

                3. C. Confirmed case

         37. 2.37. SEVERE ACUTE RESPIRATORY SYNDROME — SARS (SARS-coronavirus, SARS-CoV)

             1. Clinical Criteria

             2. Laboratory Criteria

             3. Epidemiological Criteria

             4. Case Classification for the inter-epidemic period

                1. A. Possible case

                2. B. Probable case

                3. C. Nationally confirmed case

                4. D. Confirmed case

             5. Case Classification during an outbreak

                1. A. Possible case

                2. B. Probable case

                3. C. Nationally confirmed case

                4. D. Confirmed case

         38. 2.38. SHIGA TOXIN/VEROCYTO-TOXIN PRODUCING ESCHERICHIA COLI INFECTION (STEC/VTEC)

             1. Clinical Criteria

                1. STEC/VTEC diarrhoea

                2. HUS

             2. Laboratory Criteria

             3. Epidemiological Criteria

             4. Case Classification

                1. A. Possible case of STEC-associated HUS

                2. B. Probable case of STEC/VTEC

                3. C. Confirmed case of STEC/VTEC

         39. 2.39. SHIGELLOSIS (Shigella spp.)

             1. Clinical Criteria

             2. Laboratory Criteria

             3. Epidemiological Criteria

             4. Case Classification

                1. A. Possible case NA

                2. B. Probable case

                3. C. Confirmed case

         40. 2.40. SMALLPOX (Variola virus)

             1. Clinical Criteria

             2. Laboratory Criteria

             3. Epidemiological Criteria

             4. Case Classification

                1. A. Possible case

                2. B. Probable case

                3. C. Confirmed case

         41. 2.41. SYPHILIS (Treponema pallidum)

             1. Clinical Criteria

             2. Laboratory Criteria

             3. Epidemiological Criteria

             4. Case Classification

                1. A. Possible case NA

                2. B. Probable case

                3. C. Confirmed case

         42. 2.42. SYPHILIS, CONGENITAL AND NEONATAL (Treponema pallidum)

             1. Clinical Criteria

             2. Laboratory Criteria

             3. Epidemiological Criteria

             4. Case Classification

                1. A. Possible case NA

                2. B. Probable case

                3. C. Confirmed case

         43. 2.43. TETANUS (Clostridium tetani)

             1. Clinical Criteria

             2. Laboratory Criteria

             3. Epidemiological Criteria NA

             4. Case Classification

                1. A. Possible case NA

                2. B. Probable case

                3. C. Confirmed case

         44. 2.44. TICK-BORNE ENCEPHALITIS (TBE virus)

             1. Clinical Criteria

             2. Laboratory Criteria

             3. Epidemiological Criteria

             4. Case Classification

                1. A. Possible case NA

                2. B. Probable case

                3. C. Confirmed case

         45. 2.45. TOXOPLASMOSIS, CONGENITAL (Toxoplasma gondii)

             1. Clinical Criteria

             2. Laboratory Criteria

             3. Epidemiological Criteria NA

             4. Case Classification

                1. A. Possible case NA

                2. B. Probable case NA

                3. C. Confirmed case

         46. 2.46. TRICHINELLOSIS (Trichinella spp.)

             1. Clinical Criteria

             2. Laboratory Criteria

             3. Epidemiological Criteria

             4. Case Classification

                1. A. Possible case NA

                2. B. Probable case

                3. C. Confirmed case

         47. 2.47. TUBERCULOSIS (Mycobacterium tuberculosis complex)

             1. Clinical Criteria

             2. Laboratory Criteria

             3. Epidemiological Criteria NA

             4. Case Classification

                1. A. Possible case

                2. B. Probable case

                3. C. Confirmed case

         48. 2.48. TULARAEMIA (Francisella tularensis)

             1. Clinical Criteria

             2. Laboratory Criteria

             3. Epidemiological Criteria

             4. Case Classification

                1. A. Possible case NA

                2. B. Probable case

                3. C. Confirmed case

         49. 2.49. TYPHOID/PARATYPHOID FEVER (Salmonella typhi/paratyphi)

             1. Clinical Criteria

             2. Laboratory Criteria

             3. Epidemiological Criteria

             4. Case Classification

                1. A. Possible case NA

                2. B. Probable case

                3. C. Confirmed case

         50. 2.50. VIRAL HAEMORRHAGIC FEVERS (VHF)

             1. Clinical Criteria

             2. Laboratory Criteria

             3. Epidemiological Criteria

             4. Case Classification

                1. A. Possible case NA

                2. B. Probable case

                3. C. Confirmed case

         51. 2.51. WEST NILE FEVER (West Nile virus infection, WNV)

             1. Clinical Criteria

             2. Laboratory Criteria

             3. Epidemiological Criteria

             4. Case Classification

                1. A. Possible case NA

                2. B. Probable case

                3. C. Confirmed case

         52. 2.52. YELLOW FEVER (Yellow fever virus)

             1. Clinical Criteria

             2. Laboratory Criteria

             3. Epidemiological Criteria

             4. Case Classification

                1. A. Possible case NA

                2. B. Probable case

                3. C. Confirmed case

         53. 2.53. YERSINIOSIS (Yersinia enterocolitica, Yersinia pseudotuberculosis)

             1. Clinical Criteria

             2. Laboratory Criteria

             3. Epidemiological Criteria

             4. Case Classification

                1. A. Possible case NA

                2. B. Probable case

                3. C. Confirmed case

      3. 3. CASE DEFINITIONS OF SPECIAL HEALTH ISSUES

         1. 3.1. GENERAL CASE DEFINITION OF NOSOCOMIAL INFECTION (OR ‘HEALTHCARE-ASSOCIATED INFECTION’)

            1. 3.1.1. BJ: BONE AND JOINT INFECTION

               1. BJ-BONE: Osteomyelitis

                  1. Note reporting instruction:

               2. BJ-JNT: Joint or bursa

               3. BJ-DISC: Disc space infection

            2. 3.1.2. BSI: BLOODSTREAM INFECTION

               1. BSI: Laboratory-confirmed bloodstream infection

            3. 3.1.3. CNS: CENTRAL NERVOUS SYSTEM INFECTION

               1. CNS-IC: Intracranial infection (brain abscess, subdural or epidural infection, encephalitis)...

                  1. Note reporting instruction:

               2. CNS-MEN: Meningitis or ventriculitis

                  1. Note reporting instructions:

               3. CNS-SA: Spinal abscess without meningitis

                  1. Note reporting instruction:

            4. 3.1.4. CRI: CATHETER-RELATED INFECTION

               1. CRI1-CVC: Local CVC-related infection (no positive blood culture)

               2. CRI1-PVC: Local PVC-related infection (no positive blood culture)

               3. CRI2-CVC: General CVC-related infection (no positive blood culture)

               4. CRI2-PVC: General PVC-related infection (no positive blood culture)

               5. CRI3-CVC: microbiologically confirmed CVC-related bloodstream infection

               6. CRI3-PVC: microbiologically confirmed PVC-related bloodstream infection

            5. 3.1.5. CVS: CARDIOVASCULAR SYSTEM INFECTION

               1. CVS-VASC: Arterial or venous infection

                  1. Note reporting instructions:

               2. CVS-ENDO: Endocarditis

               3. CVS-CARD: Myocarditis or pericarditis

               4. CVS-MED: Mediastinitis

                  1. Note reporting instruction:

            6. 3.1.6. EENT: EYE, EAR, NOSE, THROAT, OR MOUTH INFECTION

               1. EENT-CONJ: Conjunctivitis

                  1. Note reporting instructions:

               2. EENT-EYE: Eye, other than conjunctivitis

               3. EENT-EAR: Ear mastoid

               4. EENT-ORAL: Oral cavity (mouth, tongue, or gums)

                  1. Note reporting instruction:

               5. EENT-SINU: Sinusitis

               6. EENT-UR: Upper respiratory tract, pharyngitis, laryngitis, epiglottitis

            7. 3.1.7. GI: GASTROINTESTINAL SYSTEM INFECTION

               1. GI-CDI: Clostridium difficile infection

               2. GI-GE: Gastroenteritis (excl. CDI)

               3. GI-GIT: Gastrointestinal tract (oesophagus, stomach, small and large bowel, and...

               4. GI-HEP: Hepatitis

                  1. Note reporting instructions:

               5. GI-IAB: Intraabdominal, not specified elsewhere including gallbladder, bile ducts, liver...

                  1. Note reporting instruction:

            8. 3.1.8. LRI: LOWER RESPIRATORY TRACT INFECTION, OTHER THAN PNEUMONIA

               1. LRI-BRON: Bronchitis, tracheobronchitis, bronchiolitis, tracheitis, without evidence of pneumonia

                  1. Note reporting instruction:

               2. LRI-LUNG: Other infections of the lower respiratory tract

                  1. Note reporting instruction:

            9. 3.1.9. NEO: SPECIFIC NEONATAL CASE DEFINITIONS

               1. NEO-CSEP: Clinical Sepsis

               2. NEO-LCBI: Laboratory-confirmed BSI

                  1. Note reporting instructions:

               3. NEO-CNSB: Laboratory-confirmed BSI with coagulase-negative staphylococci (CNS)

                  1. Note reporting instructions:

               4. NEO-PNEU: Pneumonia

               5. NEO-NEC: Necrotising enterocolitis

            10. 3.1.10. PN: PNEUMONIA

                1. (a) Bacteriologic diagnostic performed by:

                2. (b) Alternative microbiology methods (PN 3)

                3. (c) Others

                   1. Note: PN 1 and PN 2 criteria were validated without previous...

                4. Intubation-associated pneumonia (IAP)

                   1. Note: Pneumonia for which intubation was started on the day of...

            11. 3.1.11. REPR: REPRODUCTIVE TRACT INFECTION

                1. REPR-EMET: Endometritis

                   1. Note reporting instruction:

                2. REPR-EPIS: Episiotomy

                3. REPR-VCUF: Vaginal cuff

                   1. Note reporting instruction:

                4. REPR-OREP: Other infections of the male or female reproductive tract...

                   1. Note reporting instructions:

            12. 3.1.12. SSI: SURGICAL SITE INFECTION

                1. Note: All definitions are to be assumed to be confirmed for...

                2. Superficial incisional (SSI-S)

                3. Deep incisional (SSI-D)

                4. Organ/Space (SSI-O)

            13. 3.1.13. SST: SKIN AND SOFT TISSUE INFECTION

                1. SST-SKIN: Skin infection

                   1. Note reporting instructions:

                2. SST-ST: Soft tissue (necrotising fascitis, infectious gangrene, necrotising cellulitis, infectious...

                   1. Note reporting instructions:

                3. SST-DECU: Decubitus ulcer, including both superficial and deep infections

                4. SST-BURN: Burn

                5. SST-BRST: Breast abscess or mastitis

            14. 3.1.14. SYS: SYSTEMIC INFECTION

                1. SYS-DI: Disseminated infection

                   1. Note reporting instructions:

                2. SYS-CSEP: Clinical sepsis in adults and children

                   1. Note reporting instructions:

            15. 3.1.15. UTI: URINARY TRACT INFECTION

                1. UTI-A: microbiologically confirmed symptomatic UTI

                2. UTI-B: not microbiologically confirmed symptomatic UTI

         2. 3.2. GENERIC CASE DEFINITION OF ANTIMICROBIAL RESISTANCE

            1. Definition

            2. Clinically Susceptible (S)

            3. Clinically Intermediate (I)

            4. Clinically Resistant (R)

            5. Clinical breakpoints are presented as S≤x mg/L; I>x, ≤y mg/L;...