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7 Guidelines On Middle East Respiratory Syndrome Coronavirus (MERS-CoV) Management In Malaysia No. Items Page 1. Flow Chart for Management of Acute Respiratory Infections When MERS-CoV Is 1 Suspected (Annex 1) 2. MERS-CoV: The Case Definitions (Annex 2) 2 3. MERS-CoV: Assessing The Degree Of Severity (Annex 3) 5 4. MERS-CoV: The Notification Form (Annex 4) 6 5. MERS-CoV: The Infection Prevention And Control (IPC) Measures (Annex 5) 7 6. Health Alert Card / Kad Amaran Kesihatan (Annex 6) Home Assessment Tool (Annex 7a) Tatacara Penilaian Kesihatan Kendiri (Annex 7b) Specimens Suitable For Testing MERS-CoV Based On Current Evidence (Annex 8) Laboratory Testing for MERS-COV Diagnosis (Annex 9) Laboratory Testing for MERS-COV Sero-Epidemiological Study (Annex 10) Triple Layer Packaging (Annex 11) Agihan Makmal Yang Mengendalikan Sampel Klinikal Bagi MERS-CoV Mengikut Lokasi Fasiliti Yang Menghantar (Annex 12) 14. Institut Penyelidikan Perubatan (IMR): Senarai Pegawai Untuk Dihubungi Untuk Penghantaran Sampel Bagi Ujian Pengesahan Kedua (Second Confirmatory Test) MERS-CoV Di Luar Waktu Pejabat, Hujung Minggu Dan Cuti Umum (Annex 13) 15. Handling of Patient Under Investigation (PUI) for MERS-CoV That Was Brought-In- Dead (BID) (Annex 14) MERS-CoV: Ringkasan Tatacara Pengurusan Jenazah Islam (Annex 15) A Laboratory-Confirmed MERS-CoV Infection: Flow Chart For Field Response Activities (Annex 16) Senarai Kontak Rapat Kepada Kes Probable / Confirmed MERS-CoV (Annex 17) MERS-CoV: Borang Siasatan Kes (Annex 18) MERS-CoV Infection: Management Of Close Contacts To A Probable / Confirmed Case (Annex 19) 21. Monitoring Form For Personnel Potentially Exposed To Middle East Respiratory Syndrome Coronavirus (MERS-CoV) Infection (Annex 20) 33 34

8 No. Items Page 22. Borang Pemantauan Harian Bagi Kontak Rapat Kepada Kes Yang Berpotensi Dijangkiti 35 Middle East Respiratory Syndrome Coronavirus (MERS-CoV) (Annex 21) 23. Home Assessment Tool (To Be Given To The Contacts) (Annex 22a) Tatacara Penilaian Kesihatan Kendiri (Untuk Diagihkan Kepada Kontak) (Annex 22b) Perintah Pengawasan Dan Pemerhatian Di Rumah Kediaman Bagi Kontak Jangkitan Middle East Respiratory Syndrome Coronavirus (MERS-CoV) Yang Bergejala Di Bawah Seksyen 15(1) Akta Pencegahan Dan Pengawalan Penyakit Berjangkit 1988 (Akta 342) (Annex 23) 26. Pelepasan Dari Menjalani Perintah Pengawasan Dan Pemerhatian Di Rumah Kediaman Bagi Kontak Jangkitan Middle East Respiratory Syndrome Coronavirus (MERS-CoV) Yang Bergejala Di Bawah Seksyen 15(1) Akta Pencegahan Dan Pengawalan Penyakit Berjangkit 1988 (Akta 342) (Annex 24) 27. Flow Chart For Screening Of Visitors And Crews Arriving From Middle East Countries At The International Entry Points (Annex 25) 28. Management of MERS-CoV Related Events by the International Entry Point, Health Office (Annex 26) Public Health Passenger Locator Card (Annex 27) Nasihat Kesihatan Berkaitan Jangkitan Middle East Respiratory Syndrome Coronavirus (MERS-CoV) Untuk Jemaah Haji Atau Umrah Dan Pelawat (Annex 28) 31. Frequently Asked Questions (FAQ) On Middle East Respiratory Syndrome Coronavirus (MERS CoV) (Annex 29) 32. Contact Details of the National Crisis Preparedness & Response Centre (CPRC), Disease Control Division and the State Health Departments (Annex 30)

9 ' Annex 1 ' Flow Chart For Management Of Acute Respiratory Infections When MERS-CoV Is Suspected Patients presenting with acute respiratory infection with history of travelling to the Middle East or other affected countries with active transmission such as Republic of Korea (ROK) within 14 days before onset of illnes Allow to go home with HOME ASSESSMENT TOOL (Refer Annex 7a/7b) MILD Illness (A) The Laboratory: - To inform the following regarding the lab result obtained: The requesting hospital The respective District Health Office (PKD) The respective State Health Department (JKN) The National CPRC (B) The Respective Hospitals: - If patient is HIGHLY SUSPICIOUS for MERS-CoV infection, additional lower respiratory tract specimens (LRTS) should be collected and tested - Maintain appropriate infection prevention and control measures (Annex 5) - Continue treatment - Upon recovery, discharge patient The Outpatient Clinics / Emergency Department of Hospitals (Public / Private): - Screening / Triaging - Initiate and consistently apply infection prevention & control measures (Annex 5) - Availability of HEALTH ALERT CARD (Annex 6)? (If available, to document it within the patient record) - Clinical examination - Chest X-Ray (if available) SEVERITY? (Refer Annex 3) NEGATIVE MODERATE to SEVERE Illness OR also known as the Patient Under Investigation (PUI) for MERS-CoV (Refer Annex 2 for the case definition) LAB RESULT? POSITIVE The Laboratory: - To send for SECOND confirmatory test to IMR (Annex 13) - IMMEDIATE dissemination of the result to the following SIMULTANEOUSLY: The Outpatient Clinics: - Immediate referral to the nearest hospital: Following consultation with the physician To send patient to the hospital using an ambulance - To notify using Annex 4 to the following SIMULTANEOUSLY: The National CPRC The respective State Health Department (JKN) The respective District Health Office (PKD) The Emergency Department of Hospitals: - Admit patient following consultation with the physician - In the event of PUI for MERS-CoV that was brought-in-dead (BID), refer Annex 14 for further management of the body (A) The PKD: To verify, validate and record the information received from the respective facility (B) The JKN: To verify, validate and record the information received from the respective facility with relevant PKD (C) The National CPRC: To verify, validate and record the information received from the respective facility with relevant JKN In The Ward: - Treat accordingly - Maintain appropriate infection prevention and control measures (Refer Annex 5) - To notify using Annex 4 to the following SIMULTANEOUSLY: The National CPRC The respective State Health Department (JKN) The respective District Health Office (PKD) - To send the INDICATED specimen (Annex 8) for MERS-CoV test to the identified laboratory (Annex 12) - If the patient died while in the ward, refer Annex 15 for further management of the body The Treating Hospital: - To inform the following regarding the lab result obtained: The respective PKD and JKN The National CPRC - Continue treatment - Maintain appropriate infection prevention and control measures (Annex 5) - Refer Annex 19 for management of personnel who are in close physical contact to the case or who were handling the specimens. Monitor the symptoms using the format as described in Annex Risk Communication activities. - Before discharge, to repeat the test. Allow discharge ONLY if repeated test is negative The Respective PKD: - To verify and validate the information received - To proceed with INTENSIVE field investigation as described in Annex Maintain appropriate infection prevention and control (Annex5) - To submit reports to the JKN: DAILY report: on daily basis throughout 1 (one) incubation period from the onset of the confirmed case FINAL report: to be submitted after completion of 2 (two) incubation period from the onset of the confirmed case - Risk Communication activities. - Advise (if needed) to Private Clinic/Hospital The Respective State Health Department (JKN): - To verify and validate the information received - To submit reports to the National CPRC: DAILY report: on daily basis throughout 1 (one) incubation period from the onset of the confirmed case FINAL report: to be submitted after completion of 2 (two) incubation period from the onset of the confirmed case - Risk Communication activities. The National CPRC: - To verify and validate the information received - To notify Malaysia National IHR Focal Point (NFP) for further action - If needed, to involve OTHER JKN for contact tracing activity - Risk Communication activities. 1

10 Annex 2 MERS-CoV: THE CASE DEFINITIONS 1. Patient Under Investigation (PUI) for MERS-CoV Infection a) A person with an acute respiratory infection, with history of fever and cough and indications of pulmonary parenchymal disease (e.g. pneumonia or ARDS), based on clinical or radiological evidence, who require admission to hospital, with no other aetiology that fully explains the clinical presentation. 1 In addition, clinicians should be alert to the possibility of atypical presentations in patients who are immunocompromised. AND any of the following: i. the person resides in the Middle East, or other affected countries with active transmission such as Republic of Korea (ROK), in particular where human infections have been reported, and in countries where MERS CoV is known to be circulating in dromedary camels; ii. a member of a cluster 2 of patients with severe acute respiratory illness (e.g. fever, and pneumonia requiring hospitalization) of unknown aetiology in which MERS-COV is being evaluated, in consultation with state and local health departments in Malaysia. b) A person with an acute respiratory infection, with history of fever and cough and indications of pulmonary parenchymal disease (e.g. pneumonia or ARDS), based on clinical or radiological evidence, and who travelled within 14 days before onset of illness, to the Middle East, or other affected countries with active transmission such as Republic of Korea (ROK) or in countries where MERS CoV is known to be circulating in dromedary camels or where human infections have recently occurred. c) Individuals with acute respiratory illness of any degree of severity who, within 14 days before onset of illness, had any of the following exposure: i. close physical contact 3 with a confirmed or probable case of MERS CoV infection, while that patient was ill; ii. a healthcare facility in a country within 2 months of the last laboratory confirmed case of hospital associated MERS CoV infections have been reported; 2

11 iii. direct contact with dromedary camels or consumption or exposure to dromedary camel products (raw meat, unpasteurized milk, urine) in countries where MERS CoV is known to be circulating in dromedary camel populations or where human infections occurred as a result of presumed zoonotic transmission. 1 Testing should be according to local guidance for management of community acquired pneumonia. Examples of other aetiologies include Streptococcus pneumoniae, Haemophilus influenzae type B, Legionella pneumophila, other recognized primary bacterial pneumonias, influenza, and respiratory syncytial virus. 2 A cluster is defined as two or more persons with onset of symptoms within the same 14 day period, and who are associated with a specific setting, such as a classroom, workplace, household, extended family, hospital, other residential institution, military barracks or recreational camp. 3 Close contact is defined as: Health care associated exposure, including providing direct care for MERS CoV patients, working with health care workers infected with MERS CoV, visiting patients or staying in the same close environment of a MERS CoV patient. Working together in close proximity or sharing the same classroom environment with a with MERS CoV patient Traveling together with MERS CoV patient in any kind of conveyance Living in the same household as a MERS CoV patient The epidemiological link may have occurred within a 14 day period before or after the onset of illness in the case under consideration. 2. Probable Case: Three combination of clinical, epidemiological and laboratory criteria can define a probable case: i) A person with a febrile acute respiratory illness with clinical, radiological, or histopathological evidence of pulmonary parenchymal disease (e.g. pneumonia or Acute Respiratory Distress Syndrome); AND Testing for MERS-CoV is unavailable or negative on a single inadequate specimen 4 ; AND The patient has a direct epidemiologic-link with a confirmed MERS-CoV case 5. ii) A person with a febrile acute respiratory illness with clinical, radiological, or histopathological evidence of pulmonary 3

12 parenchymal disease (e.g. pneumonia or Acute Respiratory Distress Syndrome); AND An inconclusive MERS-CoV laboratory test (that is, a positive screening test without confirmation) 6 ; AND A resident of or traveller to Middle Eastern countries, or other affected countries with active transmission such as Republic of Korea (ROK), where MERS-CoV virus is believed to be circulating in the 14 days before onset of illness. iii) A person with an acute febrile respiratory illness of any severity; AND An inconclusive MERS-CoV laboratory test (that is, a positive screening test without confirmation) 6 ; AND The patient has a direct epidemiologic-link with a confirmed MERS-CoV case 5. 4 An inadequate specimen would include a nasopharyngeal swab without an accompanying lower respiratory specimen, a specimen that has had improper handling, is judged to be of poor quality by the testing laboratory or was taken too late in the course of illness. 5 A direct epidemiological link may include: Close physical contact Working together in close proximity or sharing the same classroom environment Travelling together in any kind of conveyance Living in the same household The epidemiological link may have occurred within a 14 day period before or after the onset of illness in the case under consideration 6 Inconclusive tests may include: A positive screening test without further confirmation such as testing positive on a single PCR target Serological assay considered positive by the testing laboratory 3. Confirmed Case: A person with laboratory confirmation of infection with the MERS-CoV. 4

13 MERS-CoV: ASSESSING THE DEGREE OF SEVERITY Annex 3 No. Severity Description 1. MILD Low-grade fever, cough, malaise, rhinorrhea, sore throat without shortness of breath or difficulty in breathing, without increased respiratory secretion, i.e. sputum or hemoptysis, any gastro-intestinal symptoms such as nausea, vomiting and/or diarrhoea. 2. MODERATE SEVERE a) Respiratory impairment: Tachypnoea, respiratory rate > 24/minute Inability to complete sentence in one breath Use of accessory muscles of respiration, supraclavicular recession Oxygen desaturation 92% on pulse oximetry Decreased effort tolerance since onset of the symptoms Respiratory exhaustion Chest pains b) Evidence of clinical dehydration or clinical shock: Systolic blood pressure < 90 mmhg and/or diastolic blood pressure < 60 mmhg Capillary refill time > 2 seconds, reduced skin tugor c) Altered conscious level (especially in extremes of age): New confusion, striking agitation or seizures d) Other clinical concerns: Rapidly progressive (especially high grade fever > 3 days) or serious atypical illness Severe and persistent vomiting and/or diarrhoea 5

14 NOTIFICATION FORM FOR MERS-CoV CASE Annex 4 Disease Control Division Other, specify: Others, please state: [dd/mm/yy] : Date: Date : If patient died: If yes, please state the name and address (please state) 6

15 Annex 5 MERS-CoV: THE INFECTION PREVENTION AND CONTROL (IPC) MEASURES 1. THE INFECTION AND PREVENTION CONTROL GUIDING PRINCIPLES The principles of IPC for acute respiratory infection patient care include: a) Early and rapid recognitions; b) Application of routine IPC precautions (Standard Precautions) for all patients; c) Additional precautions in selected patients (i.e. based on the presumptive diagnosis); d) Establishment of an IPC infrastructure for the healthcare facility, to support IPC activities. IPC strategies in healthcare facilities are commonly based on early recognition and source control, administrative controls, environmental and engineering controls and personal protective equipment (PPE). 2. STANDARD PRECAUTIONS Standards Precautions are routine IPC precautions that should apply to ALL patients, in ALL healthcare settings. The precautions, described in detail within Chapter 3.1 of the Policies And Procedures On Infection Control Ministry of Health Malaysia; 2010 are: a) Hand hygiene; b) Use of personal protective equipment (PPE); c) Respiratory hygiene; d) Environmental control (cleaning and disinfection); e) Waste management; f) Packing and transporting patient-care equipment, linen, laundry and waste from the isolation areas; g) Prevention of needle-stick or sharps injuries; Rationale: Standard Precautions are the basic IPC precautions in health care. They are intended to minimize spread of infection associated with health care and to avoid direct contact with patient s blood, body fluids, secretions and non-intact skin. The SARS outbreak (2003) illustrated the critical importance of basic IPC precautions in health care facilities. Transmission of SARS within health care facilities was often associated with lack of compliance with Standard Precautions. The threat of emerging respiratory infectious diseases makes the promotion of Standard Precautions more important than ever and it should be a priority in all health care facilities. 7

16 3. AIRBORNE PRECAUTIONS Introduction Designed to prevent the transmission of diseases by droplet nuclei (particles < 5 µm) or dust particles containing the infectious agents. These particles can remain suspended in the air and travel long distances, If the particles are inhaled, a susceptible host may develop infection. Transmission of droplet nuclei at short range may also occur during special circumstances, for examples: Performance of aerosol-generating procedures associated with pathogen transmission in rooms that are inadequately ventilated; and Lack of adequate use of PPE e.g. as happened with SARS. Patient Placement In descending order of preference: Negative pressure room en-suite bath; Single room (nursed with door closed) and en-suite bath; Single room; Cohort (not recommended unless absolutely necessary) to consult Infectious Disease Physicians / Microbiologists Respiratory Protection Wear respiratory protection (i.e. particulate respirators) when entering the room of the patient; Whenever possible, use adequately ventilated single rooms when performing aerosol-generating procedures. Face Shield / Eye As per Standard Precautions. Protection (For procedures/activities likely to generate splashes/sprays of blood, body fluids, secretions and excretions). Gloves & Hand Washing As per Standard Precautions. Gown Patient Transport (When touching blood, body fluid secretions, excretions, contaminated items, mucous membranes, non-intact skin). As per Standard Precautions. (For procedures/activities likely to generate splashes/sprays of blood, body fluids, secretions and excretions). Limit the movement and transport of the patient from the room to essential purposes only. If transport or movement is necessary, minimize patient dispersal of droplet nuclei by placing a surgical mask on patient. 8

17 4. DROPLET PRECAUTIONS Introduction Designed to prevent the transmission of diseases by large particle (droplet) (particles >5 µm) or dust particles containing the infectious agent. Unlike droplet nuclei, droplets are larger, do not remain suspended in the air and do not travel long distances. They are produced when the infected patients talks, coughs or sneezes and during some procedures (e.g. suctioning and bronchoscopy). A susceptible host may become infected if the infectious droplets land on mucosal surfaces of the nose, mouth or eye. Patient Placement No special air handling or ventilation required. In descending order of preference: Single room with en-suite bath; Single room; Cohort place the patient in a room with a patient(s) who has active infection with the same microorganisms but with no other infection. In the general ward, but maintain a spatial separation of at least 1 metre between infected patient and other patients and visitors. Place an isolation trolley/tray* at the entrance of the isolation zone. Respiratory Protection Face Shield / Eye Protection Gloves & Hand Washing Gown Patient Transport *Isolation trolley/tray must contain the following items: non-sterile gloves, non-sterile gowns, surgical masks, thermometer, BP set, stethoscope, alcohol hand rub. Wear surgical mask when working within 1 metre of the patient. If placed in a single room, wear surgical mask before entering the room. As per Standard Precautions. (For procedures/activities likely to generate splashes/sprays of blood, body fluids, secretions and excretions). As per Standard Precautions. (When touching blood, body fluid secretions, excretions, contaminated items, mucous membranes, non-intact skin). As per Standard Precautions. (For procedures/activities likely to generate splashes/sprays of blood, body fluids, secretions and excretions). Limit the movement and transport of the patient from the room to essential purposes only. If transport or movement is necessary, minimize patient dispersal of droplet nuclei by placing a surgical mask on patient. 9

18 5. CONTACT PRECAUTIONS Background Used to prevent the transmission of epidemiologically important organisms from an infected or colonized patient through direct (touching the patient) or indirect (touching contaminated objects or surfaces in the patient s environment) contact. Patient Placement Respiratory Protection Face Shield / Eye Protection Gloves & Hand Washing In descending order of preference: Single room with en-suite bath; Single room; Cohort place the patient in a room with a patient(s) who has active infection with the same microorganisms but with no other infection. In the general ward with an isolation trolley/tray* beside the bed. *Isolation trolley/tray must contain the following items: non-sterile gloves, non-sterile gowns, surgical masks, thermometer, BP set, stethoscope, alcohol hand rub. As per Standard Precautions. (For procedures/activities likely to generate splashes/sprays of blood, body fluids, secretions and excretions). As per Standard Precautions. (For procedures/activities likely to generate splashes/sprays of blood, body fluids, secretions and excretions). In addition to Standard Precautions, wear gloves (clean, non-sterile gloves are adequate) when entering the room. During the course of providing care for a patient, change gloves after having contact with infective material that may contain high concentrations of microorganisms (faecal material or wound drainage). Remove gloves before leaving the patient s environment and wash hands immediately with soap or a waterless antiseptic agent. After gloves removal and hand washing, ensure that hands do not touch potentially contaminated environmental surfaces or items in the patient s room to avoid transfer of micro-organisms to other patients or environment. 10

19 Gown In addition to Standard Precautions, wear a gown/apron (a clean, non-sterile gown/apron is adequate) when entering the room if you anticipate that your clothing will have substantial contact with the patient, environmental surfaces or items in the patient s room or if the patient is incontinent or has diarrhoea, an ileostomy, a colostomy or wound drainage not contained by a dressing. Remove the gown before leaving the patient s environment. Patient-Care Equipment Patient Transport After gown removal, ensure that clothing does not contact potentially contaminated environmental surfaces to avoid transfer of micro-organisms to other patients or environments. Dedicate the use of non-critical patient-care equipment such as thermometer, stethoscope, BP set to a single patient (or cohort of patients infected or colonized with the pathogen requiring precautions). If these items must be shared, they should be cleaned and disinfected before re-use. Limit the movement and transport of the patient from the room to essential purposes only. If transport or movement is necessary, use clean linen. Cover all open wounds before transport. NOTE: This annex is a summary of specific WHO and MOH Malaysia guidance on infection prevention and control (IPC) which have already been published. For further information, kindly refer to these documents: i. Infection prevention and control of epidemic- and pandemic-prone acute respiratory diseases in health care WHO Guidelines. Geneva, World Health Organization, Available at ii. Policies and procedures on infection control. Ministry of Health Malaysia, Available at 11

20 KAD AMARAN KESIHATAN BAGI JEMAAH UMRAH / HAJI / PELAWAT DAN ANAK KAPAL YANG BARU PULANG DARI TANAH SUCI ATAU KAWASAN YANG DIJANGKITI MIDDLE EAST RESPIRATORY SYNDROME CORONAVIRUS (MERS-CoV) Simpan kad ini selama 14 hari setelah kembali ke Malaysia. Pantau suhu badan anda dan awasi gejala seperti demam ( 38 C), batuk dan susah bernafas. Jika anda tidak sihat sila berjumpa doktor dengan kadar segera. Begitu juga, jika anda mempunyai gejala tersebut: i. Tutup mulut dan hidung anda menggunakan tisu apabila anda batuk dan bersin. Sejurus selepas itu, buang tisu yang telah digunakan ke dalam tong sampah. Cuci tangan dengan sabun dan air atau bahan pencuci tangan (hand sanitizer) selepas batuk atau bersin; ii. Amalkan adab batuk yang baik; iii. Pakai penutup mulut dan hidung (mask) apabila terpaksa berhubung/ berurusan dengan orang lain; iv. Pastikan anda menjaga kebersihan diri sepanjang masa. Kepada Pengamal Perubatan Yang Merawat Pesakit Ini: Individu yang membawa kad ini adalah merupakan penumpang atau anak kapal yang baru pulang dari negara rantau Timur Tengah (Middle East) atau negara yang mengalami penularan aktif seperti Republik Korea (ROK) baru-baru ini. Jika anda mendapati beliau mengalami gejala seperti demam ( 38 C), batuk dan susah bernafas, sila rujuk ke hospital yang berhampiran dengan kadar segera. Annex 6 HEALTH ALERT CARD Keep this card for the next 14 days after returning to Malaysia. Monitor your body temperature and look out for fever ( 38 0 C) and symptoms of cough and/or breathing difficulty. If these symptoms were to develop and you are not feeling well, seek medical advice immediately. As such, kindly practice the following: i. Cover your mouth and nose using tissue whenever you cough or sneeze. Throw the tissue in the thrash after you use it. Wash your hands with soap and water or use hand sanitizer regularly; ii. Always follow cough etiquette and use face mask whenever being in public or close contact with people. iii. Always maintain good personal hygiene and cleanliness. Attention To The Attending Doctor: The person who is presenting this ALERT CARD to you had recently travelled or returned from Middle East Countries or other affected countries with active transmission such as Republic of Korea (ROK) (within the past 14 days). If the person presents with fever ( 38 0 C), cough and breathing difficulty, please refer him/her immediately to the nearest hospital. 12

21 Annex 7a *HOME ASSESSMENT TOOL Individual with fever and cough and/or sore throat are advised to seek medical care should they develop any of the symptoms and signs listed as below: Respiratory difficulties shortness of breath, rapid breathing or purple/blue discolouration of the lips Coughing out blood or blood streaked sputum Persistent chest pains Persistent diarrhea and/or vomiting Fever persisting beyond 3 days or recurring after 3 days Abnormal behavior, confusion, less responsive and / or convulsion Dizziness when standing and/or reduced urine production Practice these simple steps if you are sick: Use the medical leave provided by your doctor wisely by staying at home and rest While sick, limit contact with others as much as possible to keep from infecting them Cover your mouth and nose using tissue whenever you cough or sneeze. Throw the tissue in the thrash after you use it Always follow cough etiquette Always maintain good personal hygiene and cleanliness. Wash your hands often with soap and water, especially after coughing or sneezing. If soap and water are not available, use hand sanitizer. Use face mask whenever being in public or close contact with people *Note: This is to be given to the patient with mild respiratory illness and to be kept by them within 14 days of receiving it 13

22 Annex 7b *TATACARA PENILAIAN KESIHATAN KENDIRI Individu dengan gejala demam dan batuk dan/atau sakit tekak adalah dinasihatkan untuk mendapatkan rawatan perubatan sekiranya pada bila-bila masa mereka mengalami mana-mana gejala dan tanda seperti berikut: Kesukaran bernafas tercungap cungap, pernafasan menjadi laju atau warna bibir bertukar menjadi kebiruan Batuk berdarah Sakit dada yang berterusan Cirit birit dan/atau muntah yang berterusan Demam yang berpanjangan sehingga melebihi 3 hari atau demam yang berulang semula selepas 3 hari Perubahan tingkah laku, kurang responsif, keliru dan / atau sawan Mudah merasa pening/pusing apabila berdiri Kurang buang air kecil (daripada kebiasaannya) Amalkan langkah-langkah mudah berikut apabila anda jatuh sakit: Bagi yang bekerja / bersekolah, gunakan cuti sakit yang diberikan oleh doktor untuk berehat di rumah Hadkan pergaulan dengan mereka yang sihat di sekeliling anda Tutup mulut dan hidung anda menggunakan tisu apabila anda batuk dan bersin. Sejurus selepas itu, buang tisu yang telah digunakan ke dalam tong sampah Amalkan adab batuk yang baik Sentiasa mengamalkan tahap kebersihan diri yang tinggi seperti kerap mencuci tangan dengan menggunakan air dan sabun atau bahan pencuci tangan (hand sanitizer), terutamanya selepas batuk atau bersin. Pakai penutup mulut dan hidung (mask) apabila terpaksa berhubung/ berurusan dengan orang lain *Nota: Untuk diberikan kepada individu dengan gejala jangkitan respiratori yang ringan dan disimpan oleh mereka dalam tempoh 14 hari selepas menerimanya 14

23 Annex 8 SPECIMENS SUITABLE FOR TESTING MERS-CoV BASED ON CURRENT EVIDENCE Type of Specimen Transport Medium Deep cough sputum No 4 o C* Transport to Laboratory Purpose Diagnostic *Using wet ice or cold packs as appropriate Bronchoalveolar lavage No As for sputum Diagnostic Tracheal aspirate No As for sputum Diagnostic Nasopharyngeal aspirate No As for sputum Diagnostic Combined nasopharyngeal (NP) and oropharyngeal (OP) swab Virus transport medium (VTM) As for sputum Diagnostic Pleural fluid (from biopsy or autopsy) No As for sputum Diagnostic Lung tissue (from biopsy or autopsy) VTM and sterile saline if specimen is also for bacterial culture As for sputum Diagnostic Serum for serological testing: Paired samples are preferable with the initial samples collected in the first week of illness and the second collected 2-3 weeks later. A single serum sample should be collected at least 14 days after onset of symptoms No As for sputum Seroepidemiological study NOTE: Kindly refer to the following annexes for further information: i. Laboratory testing for MERS-COV diagnosis (Annex 9). ii. Laboratory testing for MERS-COV sero-epidemiological study (Annex 10). iii. Triple layer packaging (Annex 11). 15

24 Annex 9 LABORATORY TESTING FOR MERS-COV DIAGNOSIS LOWER RESPIRATORY TRACT SPECIMENS (LRTSs): Deep cough sputum, bronchoalveolar lavage, tracheal aspirate, pleural fluid, lung tissue NOTE: ONLY if LRTS is not possible, upper respiratory tract specimens (URTSs) may be taken: COMBINED nasopharyngeal and oropharyngeal swabs (NP/OP swabs), nasopharyngeal aspirate/wash Bronchoalveolar lavage, Tracheal aspirate, Sputum, Pleural fluid, nasopharyngeal aspirate/wash Combined NP/OP swabs, Lung tissue Plain sterile container Viral transport media (VTM) Send the specimens in ice to the laboratory ASAP Keep specimens at 4 C DO NOT FREEZE Transport specimens in ice (Triple Packaging) For screening and first confirmatory tests by: The identified laboratories (Refer Annex 12 ) Positive Negative Transport specimens in ice (Triple Packaging) For strongly suspected cases: Additional LRTS should be collected and tested For second confirmatory test by: The Virology Unit, IMR, Kuala Lumpur NOTE: Do not use wooden swab 16

25 LABORATORY TESTING FOR MERS-COV SERO-EPIDEMIOLOGICAL STUDY Annex 10 SERUM FOR SEROLOGICAL TESTING: Paired samples are preferable with the initial sample collected in the first week of illness and the second sample collected two to three weeks later. NOTE: If paired samples are not possible, a single serum sample should be collected at least 14 days after onset of symptoms. Serum samples are to be taken from the close physical contacts and the health care personnel caring for probable and confirmed MERS-CoV case PLAIN STERILE CONTAINER Send the specimens in ice to the laboratory ASAP Keep specimens at 4 C DO NOT FREEZE Transport specimens in ice (TRIPLE PACKAGING) For SEROLOGICAL TESTING by: The Virology Unit, IMR, Kuala Lumpur 17

26 Annex 11 MERS-CoV: TRIPLE LAYER PACKAGING NOTE: This annex is a summary of specific MOH Malaysia guidance on transport of biological specimens which has already been published. For further information, kindly refer to this document: i. Standard Operating Procedure for Transport of Biological Specimens in Malaysia. Ministry of Health Malaysia, Available at: idrc-sop-for-transportation-of-biological-specimens.html 18

27 Annex 12 Agihan Makmal Yang Mengendalikan Sampel Klinikal Bagi MERS-CoV Mengikut Lokasi Fasiliti Yang Menghantar Bil. Lokasi Fasiliti Yang Menghantar Sampel Makmal Yang Mengendalikan Sampel (A) FASILITI KESIHATAN KERAJAAN 1. Perlis Hospital Sultanah Bahiyah, Alor Setar, Kedah 2. Kedah Hospital Sultanah Bahiyah, Alor Setar, Kedah 3. Pulau Pinang Hospital Pulau Pinang 4. Perak Hospital Raja Permaisuri Bainun, Ipoh, Perak 5. Selangor Hospital Sungai Buloh, Selangor 6. WP Kuala Lumpur & Putrajaya Hospital Kuala Lumpur 7. Negeri Sembilan Hospital Tuanku Jaafar, Seremban, N. Sembilan 8. Melaka Hospital Melaka 9. Johor Hospital Sultanah Aminah, Johor Bahru, Johor 10. Pahang Hospital Tengku Ampuan Afzan, Kuantan, Pahang 11. Terengganu Hospital Sultanah Nur Zahirah, Kuala Terengganu, Terengganu 12. Kelantan Hospital Raja Perempuan Zainab II, Kota Bharu, Kelantan 13. Sarawak Hospital Umum Kuching, Sarawak 14. Sabah Makmal Kesihatan Awam, Kota Kinabalu, Sabah 15. WP Labuan Makmal Kesihatan Awam, Kota Kinabalu, Sabah (B) FASILITI KESIHATAN SWASTA 16. Seluruh negara Geneflux Diagnostics Sdn. Bhd., Menara KLH, Bandar Puchong Jaya, Selangor No Tel: No Fax: Lablink (M) Sdn. Bhd. Bangunan Lablink, 14 (129) Jalan Pahang Barat Off Jalan Pahang, Kuala Lumpur No Tel: / No Fax: nazri@kpjlablink.com (bermula Julai 2015) (C) SAMPEL DALAM KALANGAN KONTAK RAPAT DENGAN KES YANG DISAHKAN DIJANGKITI MERS-CoV, YANG DIKESAN MELALUI AKTIVITI ACD DI LAPANGAN 17. Semenanjung Malaysia Makmal Kes. Awam Kebangsaan (MKAK) Sg. Buloh,Selangor 18. Sarawak, Sabah dan WP Labuan Makmal Kesihatan Awam Kota Kinabalu, Sabah (D) SAMPEL SERUM DALAM KALANGAN KONTAK RAPAT (TERMASUK ANGGOTA KESIHATAN) DENGAN KES YANG DISAHKAN DIJANGKITI MERS-CoV, YANG DIKESAN MELALUI AKTIVITI ACD DI LAPANGAN 19. Seluruh negara Unit Virologi, Institut Penyelidikan Perubatan (IMR), Kuala Lumpur 19

28 MAKLUMAT TAMBAHAN: Bil. Jenis Ujian Tanggungjawab 1. Ujian saringan dan ujian pengesahan pertama (first confirmatory test) MERS-CoV 2. Ujian saringan dan ujian pengesahan pertama (first confirmatory test) MERS-CoV bagi kontak rapat dengan kes yang disahkan dijangkiti MERS-CoV, yang dikesan melalui aktiviti ACD 3. Ujian pengesahan kedua (second confirmatory test) MERS-CoV 4. Ujian serologi MERS-CoV (bagi menjalankan Kajian Sero-Epid) Makmal (1-16) sebagaimana ketetapan di atas Makmal (17-18) sebagaimana ketetapan di atas Unit Virologi, Institut Penyelidikan Perubatan (IMR), Kuala Lumpur Unit Virologi, Institut Penyelidikan Perubatan (IMR), Kuala Lumpur 20

29 Annex 13 SENARAI PEGAWAI UNTUK DIHUBUNGI UNTUK PENGHANTARAN SAMPEL BAGI UJIAN PENGESAHAN KEDUA (SECOND CONFIRMATORY TEST) MERS-CoV DI LUAR WAKTU PEJABAT, HUJUNG MINGGU DAN CUTI UMUM Pejabat : Faks : UNIT VIROLOGI, IMR No. Nama Pegawai Jawatan Pejabat No. H/P 1. Dr. Zainah Saat Ketua Unit/Pakar Perunding (Virologi) Dr. Rozainanee Mohd Zain Pakar Patologi (Mikrobiologi Perubatan) 3. Dr. Nur Izati Mustapa Pakar Patologi (Mikrobiologi Perubatan) 4. Puan TS Saraswathy Pegawai Penyelidik Kanan 5. Dr. Ravindran Thayan Pegawai Penyelidik Kanan 6. Encik Mohd Apandi Yusof Pegawai Penyelidik Kanan 7. Puan Fauziah Md Kassim Pegawai Penyelidik Kanan

30 Annex 14 Handling of Patient Under Investigation (PUI) for MERS-CoV That Was Brought-In-Dead (BID) 1. Body Transfer From Emergency Ward To Mortuary Notify the mortuary staff regarding BID in the Emergency Ward. Place body in a plastic body bag before sending to mortuary. Staff handling the body must wear appropriate personal protective equipment (PPE) and consistently maintain strict infection prevention and control measures. Body trolley must be immediately disinfected after use. 2. Post-Mortem Examination Forensic Pathologist should perform the autopsy. Staff performing the autopsy must wear appropriate PPE and consistently maintain strict infection prevention and control measures. Post-mortem examination shall be performed on highly suspicious cases for MERS-CoV infection, i.e. comprising of the combination of clinical, epidemiological and laboratory criteria: a) (Clinical) A person with a febrile acute respiratory illness with clinical, radiological or histopathological evidence of pulmonary parenchymal disease (e.g. pneumonia or Acute Respiratory Distress Syndrome); AND b) (Laboratory Criteria) Testing for MERS-CoV is unavailable; AND c) (Epidemiological) A resident of or traveller to Middle Eastern countries, or other affected countries with active transmission such as Republic of Korea (ROK), where MERS-CoV virus is believed to be circulating in the 14 days before onset of illness; OR (Epidemiological)The patient has a direct epidemiologic-link with a confirmed MERS-CoV case 1. 1 A direct epidemiological link may include: Close physical contact Working together in close proximity or sharing the same classroom environment Travelling together in any kind of conveyance Living in the same household The epidemiological link may have occurred within a 14 day period before or after the onset of illness in the case under consideration 22

31 3. Legal Aspect of Post-Mortem Examination Police shall decide the need for forensic post-mortem examination. In accordance to the Criminal Procedure Code (Act 593), the police shall certify the cause of death for cases which do not require forensic postmortem examination. Under Section 16 of the Prevention and Control of Infectious Disease Act 1988 (Act 342) (i.e. order for examination of corpse), it is stated that whenever an authorized officer suspects that a person has died of an infectious disease, he may order the corpse to be conveyed to such place as he may appoint for such examination as he may consider necessary. Under Subsection 22(3) of the Registration of Birth and Death Act 1957 (Act 299), it was stated that any medical practitioner can refuse to sign the death certificate is he suspects that death was from infectious disease and not satisfied with any diagnosis written, unless the problem has been rectified. Written consent from the next-of-kin is required for any post-mortem examination not within the above legal indication. 4. Body Release It is important to ensure that the (Assistant) Environmental Health Officer from the nearby District Health Office (PKD) was informed prior to release of the dead body. The officer shall supervise the whole process of the preparation of the dead body before leaving the mortuary. Bathing rituals by relatives is discouraged. Embalming of the dead body is discouraged as it poses an infectious risk to the handler. If embalming is necessary, it should be carried out by trained personnel adopting standard precautions. Body washing and kafan ritual for Muslim bodies to follow the guidance provided within the document entitled Garispanduan Pengurusan Jenazah Islam Dari Aspek Kesihatan (Ministry of Health Malaysia; 2006), which is available at: engurusanjenazahislam_bm.pdf;or Guidelines For The Management Of Non-Muslim Dead Bodies From Health Aspects (Ministry of Health Malaysia; 2006). Body in plastic bag is placed in a sealed coffin before leaving the mortuary. The body must be taken for burial or cremation directly from the mortuary. The body should be buried / cremated with minimum delay. Release of the dead body involving a police case, a foreigner or an unclaimed dead body is based on the available Circular of the Director General of Health No. 10, Year 2012 entitled Standard Operating Procedures of Forensic Medicine Services. 5. Precautions For Relatives And Undertakers Avoid direct contact with the body as much as possible. Relatives are strongly discouraged from touching or kissing the body. 23

32 Any unavoidable handling of the body by relatives / undertakers should be done with full precautionary measures. They must wear appropriate PPE and must be reminded about practising strict infection prevention and control measures consistently. NOTE: This annex is a summary of specific MOH Malaysia guidance on handling of dead body (particularly suspected of infectious diseases) which have already been published. For further information, kindly refer to these documents: iii. Standard Operating Procedure for Potential Infectious Disease. Ministry of Health Malaysia iv. Surat Pekeliling Ketua Pengarah Kesihatan Bilangan 17 Tahun 2008: Garispanduan Bedah Siasat Mayat Di Hospital-Hospital Kementerian Kesihatan Malaysia; ref. KKM87/P1/34/8 Jld.2 (22) dated 31 October v. Surat Pekeliling Ketua Pengarah Kesihatan Bilangan 10 Tahun 2012: Standard Operating Procedures of Forensic Medicine Services; ref. KKM87/P1/34/8 Jld.4 (76) dated 22 February Available at: 24

33 Annex 15 MERS-CoV: Ringkasan Tatacara Pengurusan Jenazah Islam Bil. Tatacara Mengendalikan Jenazah Jenazah Kes PUI / Kes Yang Disahkan Dijangkiti MERS-CoV 1. Peralatan keperluan untuk mandi jenazah: Sarung tangan getah 2 pasang Apron plastik Pelindung mata Mask But getah Takung mandian Larutan peluntur 1:10 (klorok) Mesti Mesti Digalakkan Mesti Mesti untuk jirusan pertama 2. Mengapan jenazah: Sumbat rongga dengan kapas Lapisan pertama kapas direndam dengan air bancuhan klorok. Lapisan kedua kapas biasa. Lapisan plastik Mesti guna lapisan plastik terang selepas lapisan pertama kain kafan. 3. Mencium jenazah Jenazah yang utuh di bahagian muka Jenazah yang tidak utuh di bahagian muka Tidak digalakkan Tidak boleh 4. Sembahyang jenazah Dimana-mana mengikut hukum syarak 5. Mengkebumikan jenazah Mengikut hukum syarak 6. Penyeliaan pengurusan jenazah Mesti oleh pegawai masjid / mereka yang telah dilatih atau anggota kesihatan 7. Pengendali jenazah: Basuh tangan selepas membuka sarung tangan Merendam pakaian yang tercemar dengan larutan peluntur Mandi selepas mengendalikan jenazah Mesti Mesti Mesti 8. Peralatan yang digunakan: Rendam dan basuh dengan air bancuhan larutan peluntur sebelum dibuang atau dipakai semula Peralatan berasaskan logam perlu direbus 9. Takungan mandian dan lantai dicuci / mop dengan air bancuhan larutan peluntur Mesti Mesti Mesti 25

34 NOTA: Lampiran ini adalah merupakan ringkasan dari garispanduan khusus yang telah diterbitkan oleh pihak Kementerian Kesihatan Malaysia mengenai pengurusan jenazah / mayat dari aspek kesihatan. Untuk maklumat lanjut, sila rujuk kepada dokumen seperti berikut: i. Garispanduan Pengurusan Jenazah Islam Dari Aspek Kesihatan. Kementerian Kesihatan Malaysia Melalui capaian di: nazahislam_bm.pdf ii. Guidelines For The Management Of Non-Muslim Dead Bodies From Health Aspects. Ministry of Health Malaysia

35 ' Annex 16 ' A Laboratory-Confirmed MERS-CoV Infection: Flow Chart For Field Response Activities (A) The Respective District Health Office (PKD): - Activation of the District Operations Room: Establishment of the PHE (Public Health Emergency) Task Force. To compile, update and analyze the data / information received from the field response activities. To input the findings obtained into the database (Annex 17). Risk Communication activities. To submit reports to JKN: a) DAILY report: on daily basis (i.e. by 10:00 am) throughout 1 (one) incubation period from the date of last exposure to the confirmed case. b) FINAL report: to be submitted after completion of 2 (two) incubation period from the date of last exposure to the confirmed case. (B) The Rapid Assessment Team (RAT) & The Rapid Response Team (RRT): - Consistently apply appropriate infection prevention and control measures (Annex 5) - To conduct contact tracing and field investigations using Annex Refer Annex 19 for management of close contacts. Monitor the symptoms using the format as described in Annex To input the findings obtained into the database (Annex 17) - To submit DAILY reports to the PKD (i.e. by 9:00 am) throughout 1 (one) incubation period from the date of last exposure to the confirmed case, mainly reporting on the status of the close contacts to the case. - Any specimen taken from the symptomatic close contacts, to be sent to the NPHL Sg. Buloh, Selangor /PHL Kota Kinabalu. - To trace results and update the database. - Risk Communication activities. The Respective State Health Department (JKN): - To verify and validate the information received - To submit reports to the National CPRC: DAILY report: on daily basis (i.e. by 12:00 noon) throughout 1 (one) incubation period from the date of last exposure to the confirmed case. FINAL report: to be submitted after completion of 2 (two) incubation period from the date of last exposure to the confirmed case. - Risk Communication activities. The National Public Health Laboratory (NPHL) Sg. Buloh, Selangor / The Public Health Laboratory (PHL) Kota Kinabalu, Sabah: - Management of the specimen collected from field investigations. - To inform the following regarding the lab result obtained: The requester (Clinic/hospital) The respective District Health Office (PKD). The respective State Health Department (JKN). The National CPRC. - If POSITIVE result was obtained from any of the samples: To send for SECOND confirmatory test to IMR (Annex 13). IMMEDIATE dissemination of the result to the respective PKD, JKN and the National CPRC. - Input of the result obtained into the database. - Consistently apply appropriate infection prevention and control measures (Annex 5). - Refer Annex 19 for management of the laboratory personnel who were handling the specimens collected from field investigation. Monitor the symptoms using the format as described in Annex To submit DAILY reports to the National CPRC (i.e. by 9:00 am) from the first day of handling specimens related to the event until 14 days after the date of last exposure to similar specimens, mainly reporting on the health status of the personnel involved The Infection Prevention & Control Team / The Public Health Unit (of the Respective Hospital): - Consistently apply appropriate infection prevention and control measures (Annex 5) - Refer Annex 19 for management personnel who are in close physical contact to the case or who were handling the specimens. Monitor the symptoms using the format as described in Annex To input the findings obtained to the database (Annex 17) - To submit DAILY reports to the PKD (i.e. by 9:00 am) throughout 1 (one) incubation period from the date of last exposure to the confirmed case., mainly reporting on the status of the personnel who are in close physical contact to the case or who were handling the relevant specimens. - Any specimen taken from the symptomatic personnel, to be sent to the NPHL Sg. Buloh, Selangor / PHL Kota Kinabalu, Sabah - To trace results and update the database. The National CPRC: - To verify and validate the information received. - To notify Malaysia National IHR Focal Point (NFP) for further action. - If needed, to involve OTHER JKN for contact tracing activity. - To co-ordinate the logistic matters. - To conduct and monitor the prevention and control activities centrally. - Risk Communication activities. NOTE: SEROEPIDEMIOLOGICAL investigation involving the close contacts and the respective health care personnel may be conducted, as and when required following the directive given by the DG of Health or the Deputy DG of Health (Public Health). The protocols to guide data collection for this investigation are readily available at WHO website. For further information, kindly refer to these documents: a) Seroepidemiological Investigation of Contacts of Middle East Respiratory Syndrome (MERS-CoV) Patients. Geneva, World Health Organization, Available at: b) Assessment of potential risk factors of infection of MERS-CoV among health care personnel in a health care setting. Geneva, World Health Organization, Available at: 27

36 No. Telefon Alamat Umur Jantina (L/P) No. Kad Pengenalan Tarikh Pendedahan * Kategori Kontak Nama Bil. Keputusan Tarikh Keputusan Tarikh Diambil Jenis Sampel Tarikh (Hari 14) Tarikh (Hari 13) Tarikh (Hari 12) Tarikh (Hari 11) Tarikh (Hari 10) Tarikh (Hari 9) Tarikh (Hari 8) Tarikh (Hari 7) Tarikh (Hari 6) Tarikh (Hari 5) Tarikh (Hari 4) Tarikh (Hari 3) Tarikh (Hari 2) Tarikh (Hari 1) ' Annex 17 ' NAMA KES PROBABLE / CONFIRMED MERS-CoV:. SENARAI KONTAK RAPAT KEPADA KES PROBABLE / CONFIRMED MERS-CoV # Status Pemantauan Kontak Rapat ( NOTA: Bilangan lajur untuk disediakan hendaklah mengikut bilangan hari pemantauan bagi KESEMUA kontak) Ujian Pengesahan MERS-CoV Catatan # PETUNJUK: S GR GW T Kontak berada dalam keadaan sihat. Kontak mempunyai gejala demam, batuk, selesema atau sakit tekak DAN berada di bawah Perintah Pengawasan & Pemerhatian di rumah kediamannya. Kontak mempunyai gejala jangkitan DAN dimasukkan ke hospital berdekatan bagi menerima rawatan lanjut. Tempoh pemantauan kontak telah tamat. * Kategori kontak boleh dinyatakan sebagai ahli keluarga serumah, rakan kumpulan pakej umrah / pelancongan yang sama, saudara mara, sahabat handai, komuniti, anggota kesihatan yang mempunyai kontak dengan kes berkaitan meliputi anggota kesihatan di wad di mana dia dirawat, anggota kerja di makmal yang mengendalikan spesimennya, juru x-ray yang mengendalikan ujian baginya, anggota sokongan terlibat seperti pemandu ambulans dan sebagainya. 28