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Case Definition and Surveillance Guidance for MERS-CoV Testing in Saudi Arabia - 13 May 2014

Suspect Case (patients who should be tested for MERS-CoV)1

I. A person with fever and community-acquired pneumonia or acute respiratory distress syndrome based on clinical or radiological evidence.2 OR

II. A hospitalized patient with healthcare associated pneumonia based on clinical and radiological evidence.2 OR

III. A person with 1) acute febrile (≥38°C) illness, AND 2) body aches, headache, diarrhea, or nausea/vomiting, with or without respiratory symptoms, AND 3) unexplained leucopenia (WBC<3.5x109/L) and thrombocytopenia (platelets<150x109/L)3. OR

IV. A person (including health care workers) who had protected or unprotected exposure4 to a confirmed or probable case of MERS-CoV infection and who presents with upper5 or lower6 respiratory illness within 2 weeks after exposure.7

Probable Case

A probable case is a patient in category I or II above with absent or inconclusive laboratory results for MERS-CoV and other possible pathogens who is a close contact8 of a laboratory-confirmed MERS-CoV case or who works in a hospital where MERS-CoV cases are cared for.

Confirmed Case

A confirmed case is a suspect case with laboratory confirmation9 of MERS-CoV infection.

1All suspected cases should have nasopharyngeal swabs, and, when intubated, lower respiratory secretions samples collected for MERS-CoV testing. 2Patients who meet the criteria for category I or II above should also be evaluated for common causes of community-acquired pneumonia (such as influenza A and B, respiratory syncytial virus, Streptococcus pneumoniae, Hemophilus influenzae, Staphylococcus aureus, and Legionella pneumophila). This evaluation should be based on clinical presentation and epidemiologic and surveillance information. Testing for MERS-CoV and other respiratory pathogens can be done simultaneously. Positive results for another

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respiratory pathogen (e.g H1N1 influenza) should not necessarily preclude testing for MERS-CoV because co-infection can occur. 3Laboratory tests to exclude other causes of this clinical presentation (e.g., dengue, Alkhumra hemorrhagic fever virus, CMV, EBV, typhoid fever, and malaria) should be simultaneously performed if clinically and epidemiologically indicated. 4Protected exposure is defined as contact within 1.5 meters with a patient with confirmed or probable MERS-CoV infection while wearing all personal protective equipment (surgical mask, gloves, and gowns, and, when indicated, goggles, or N95 mask). Unprotected exposure is defined as contact within 1.5 meters with a patient with confirmed or probable MERS-CoV infection without wearing all personal protective equipment (surgical mask, gloves, and gowns, and, when indicated, goggles, or N95 mask). 5Rhinorrhea, sore throat, and/or cough 6Shortness of breath, hypoxemia, or pneumonic infiltration evident on chest x-ray. 7Testing asymptomatic contacts is generally not recommended. Under certain circumstances, such testing may be considered in consultation with an Infectious Diseases/Infection Control consultant. 8Close contact is defined as a) any person who provided care for the patient, including a healthcare worker or family member, or had similarly close physical contact; or b) any person who stayed at the same place (e.g. lived with, visited) as the patient while the patient was ill. 9Confirmatory laboratory testing requires a positive PCR on at least two specific genomic targets (upE and ORF1a) OR a single positive target (upE) with sequencing of a second target (RdRpSeq or NSeq). It is strongly advised that lower respiratory specimens such as sputum, endotracheal aspirate, or bronchoalveolar lavage should be used when possible. If patients do not have signs or symptoms of lower respiratory tract infection or lower tract specimens are not possible or clinically indicated, both nasopharyngeal and oropharyngeal specimens should be collected and combined in a single collection container and tested together. If initial testing of a nasopharyngeal swab is negative in a patient who is strongly suspected to have MERS-CoV infection, patients should be retested using a lower respiratory specimen or, if not possible, a repeat nasopharyngeal and oropharyngeal specimen. For patients in whom adequate lower respiratory samples are not possible, investigators may also want to consider other types of auxiliary testing such as nasopharyngeal wash and paired acute and convalescent sera. Virus has also been demonstrated in other body fluids such as blood, urine, and stool but the usefulness of those body fluids in diagnosing MERS-CoV infection is uncertain.

Infection prevention and control precautions when caring for patients with suspected, probable or confirmed Middle East Respiratory Syndrome

CoronaVirus (MERS-CoV) infection

May 2014

This document is an updated version of the previous Ministry of Health guidelines

released on May, 20131 and February 20142. It is based on the World health organization

infection control guidelines on MERS-CoV infections3 and intended to guide healthcare

providers, administrators in health care facilities within the Kingdom of Saudi Arabia on the

infection prevention and control when caring for patients with suspected, probable or

confirmed Middle East Respiratory Syndrome CoronaVirus (MERS-CoV) infection.

I. Algorithm for managing patients with suspected and confirmed MERS-CoV4

II. Infection Prevention and Control (IP&C) principles:

Effective IP&C relies on the application of the following principles “controls” (in order of importance): A. Administrative principles:

These constitute a core of actions to prevent, detect and control infections. They include: ■ Establish a sustainable IP&C infrastructure and activities including education of

all healthcare providers, surveillance, monitoring of compliance, provision of supplies and supporting improvement as needed.

■ Adopt and implement unified IP&C policies and procedures ■ Organization of health services in order to apply source control by identifying

patients with acute respiratory infections (ARI) (including suspected MERS-CoV infections), and allowing appropriate placement and prompt application of required precautions. Recognition of ARI relies on evaluation of epidemiological, clinical and laboratory aspects of cases.

■ Apply measure to prevent overcrowding in healthcare especially in waiting areas and emergency rooms.

■ Family members and visitors in contact with ARI patients should be limited to those essential for support and who can be trained and able to comply with infection control precautions.

B. Environmental and engineering controls: ■ Insure adequate environmental ventilation in all areas within healthcare facilities ■ Insure adequate environmental cleaning ■ Maintain spatial separation of at least 1m between ARI patients and others

C. Personal Protective Equipment (PPE): ■ Apply rational and consistent use of available PPE with appropriate hand hygiene

III. Infection prevention and control when caring for patients with ARI:

The early identification, isolation and reporting of ARIs of potential concern are central to effective containment and treatment. Current evidence indicates that the primary mode of transmission of most acute respiratory diseases is through droplets, but transmission through contact (including hand contamination followed by self-inoculation) or infectious respiratory aerosols at short range can also happen for some pathogens in particular circumstances 4. In general, the principles of infection prevention and control when caring for patients with ARI are: A. Standard precautions should always be applied when caring for any patient. These include hand hygiene; use of PPE when contact with patients’ blood, body fluids, secretions (including respiratory secretions) and non-intact skin is anticipated. Standard precautions also include prevention of needle stick or sharp injuries; safe waste management; and cleaning and disinfection and when applicable sterilization of patient care equipment and linen, and cleaning and disinfection of the environment. The use of respiratory hygiene is encouraged in anyone with respiratory symptoms.

B. Additional IP&C precautions when caring for ARI: All individual including visitors and healthcare workers in contact with patients with ARI should:

● Wear a medical mask when in close contact (within 1m) or upon entering the room or cubicle of the patient. If traditional veils are used, wear the mask behind the veil.

● Perform hand hygiene before and after contact with a patient and his/her surroundings and immediately after removal of medical mask.

C. Infection prevention and control precautions for aerosol-generating procedures (AGP): Additional precautions should be observed when performing aerosol-generating procedures, which may be associated with an increased risk of infection transmission, in particular, tracheal intubation, tracheotomy, non-invasive ventilation and manual ventilation before intubation. These include:

● Wearing a disposable particulate respirator, i.e. N 95 or higher respirator (always check the seal when putting on a particulate respirator).

● Wearing eye protection (i.e. goggles or a face shield); ● Wear a clean, non-sterile, long-sleeved gown and gloves (some of these

procedures require sterile gloves); ● Wearing an impermeable apron for some procedures with expected splashes

of high fluid volumes that might penetrate the gown; ● Performing procedures in an adequately ventilated area; i.e. minimum of 6 to

12 air changes/hour in facilities with a mechanically ventilated room and at least 60 liters/second/patient in facilities with natural ventilation.

● Limiting the number of persons present in the room to the absolute minimum required for the patient’s care and support;

● Performing hand hygiene before and after contact with the patient and his or her surroundings and after PPE removal.

IV. Infection prevention and control precautions when caring for patients with suspected, probable or confirmed MERS-CoV infections:

In addition to the ARI precautions above:

■ Limit the number of visitor and family members to those essential for patient support.

■ To the extent possible, assign only skilled healthcare care providers to take care for suspected, probable or confirmed MERS-CoV patients

■ Patient placement: ● Place patients with suspected, probable or confirmed MERS-CoV infection in

adequately ventilated single rooms or Airborne Precaution rooms if available. ● The rooms used for isolation (i.e. single rooms) should be situated in an area

that is clearly segregated from other patient-care areas. ● When single rooms are not available, put patients with the same lab

confirmed diagnosis together. ● If this is not possible, place patient beds at least 1 m apart.

■ When in close contact (within 1 m) or upon entering the room of patients with probable or confirmed MERS-CoV infection, all individuals including visitors and healthcare providers should always:

○ Wear a medical mask. ○ Wear eye protection (i.e. goggles or a face shield). ○ Wear a clean, non-sterile, long-sleeved gown; and gloves (some

procedures may require sterile gloves). ○ Perform hand hygiene before and after contact with the patient and his or

her surroundings and immediately after removal of PPE. ○ Healthcare providers should refrain from touching their eyes, nose or

mouth with potentially contaminated gloved or ungloved hands. ■ Patient movement and transport:

● Avoid the movement and transport of patients out of the isolation room or area unless medically necessary. The use of portable X-ray equipment and other important diagnostic devices may make this easier. If transport is required, use routes of transport that minimize exposures of staff, other patients and visitors.

● Notify the receiving area of the patient's diagnosis and necessary precautions as soon as possible before the patient’s arrival.

● Clean and disinfect patient-contact surfaces (e.g. bed) using hospital approved disinfectant after use.

● Ensure that HCWs who are transporting patients wear appropriate PPE and perform hand hygiene afterwards.

■ Duration of isolation precautions for MERS-CoV infection: The duration of infectivity for MERS-CoV infection is unknown. Little information is currently available on viral shedding and the potential for transmission of MERS-CoV. ● While Standard Precautions should continue to be applied always, additional

isolation precautions should be used during the duration of symptomatic illness and continued for 24 hours after the resolution of symptoms.

● Patient information (e.g. age, immune status and medication, presence of parenchymal lung disease 6) should also be considered in situations where there is concern that a patient may be shedding the virus for a prolonged period. In these situations, discontinuation of isolation precautions may be

guided by laboratory testing. Isolation precautions can be discontinued if at least one respiratory sample is negative for MERS-CoV RNA.

● Discontinuation of isolation precautions should be made in conjunction with the IP&C professional or delegate.

■ Home care for patients with MERS-CoV infection: Symptomatic cases of suspected, probable or confirmed cases are better managed in a healthcare setting. If this is not possible for any reason, alternative settings for healthcare provision may need to be considered. The same principle of care in the home environment applies to symptomatic patients not requiring or no longer requiring hospitalization. The patients and the household members should be educated on personal hygiene and basic infection prevention and control measures. ● Limit contact with the ill person as much as possible ● Ensure that anyone who is at increased risk of severe disease does not care for

the ill person or come into close contact with the ill person. ● Perform hand hygiene following all contact with the ill person or his/her

immediate environment ● Respiratory hygiene should be practiced by all, especially the ill person. ● Discard materials used to cover the mouth or nose after use ● The caregiver should wear a medical mask fitted tightly to the face when in

the same room with the ill person ● Clean frequently touched surfaces such as bedside tables, bed frame, and other

bedroom furniture daily with regular household cleaners or a diluted bleach solution (1 part bleach to 99 parts water). Clean bathroom and toilet surfaces daily with regular household cleaners or a diluted bleach solution (1 part bleach to 9 parts water).

● The symptomatic person should remain at home until satisfactory resolution of the symptoms. The decision to remove the ill person from home observation should be made based on either clinical or laboratory findings or both.

● All household members should be considered contacts and their health should be monitored as described below

For details, consult the WHO Rapid advice note on home care for patients with Middle East respiratory syndrome coronavirus (MERS-CoV) infection presenting with mild symptoms and management of contacts 7.

■ Medical waste management: No special precautions are recommended; routine practices are sufficient.

■ Cleaning, Disinfection, and/or Sterilization of patient-care equipment & linen: ● If possible, use either disposable equipment or dedicated equipment (e.g.

stethoscopes, blood pressure cuffs and thermometers). If equipment needs to be shared among patients, clean and disinfect it between each patient use.

● Reusable non-critical equipment (e.g., blood pressure cuffs, stethoscopes, pulse oximeters, commodes, bedpans, walkers, etc.) should be dedicated to the use of the patient, and should be cleaned and disinfected before reuse with another patient. Single-use devices should be discarded in a hands-free waste receptacle after use.

● Ensure that cleaning, disinfection and/or sterilization procedures are followed consistently and correctly.

● Manage laundry, food service utensils in accordance with routine procedures. ■ Cleaning and disinfection of the environment:

● Hospital-grade cleaning and disinfecting agents are sufficient for environmental cleaning for the MERS-CoV virus. All horizontal and frequently touched surfaces should be cleaned at least twice daily and when soiled.

● The healthcare organization’s terminal cleaning protocol for cleaning of the patient’s room following discharge, transfer, or discontinuation of contact and droplet precautions should be followed.

● Housekeeping staff to wear protective equipment as indicated above and must be trained and made aware on the need of additional precautions

● Isolation areas should be cleaned after the rest of the ward areas and cleaning equipment should be disinfected after use.

■ Collection and handling of laboratory specimens: ● All specimens should be regarded as potentially infectious, and HCWs who

collect or transport clinical specimens should adhere strictly to Standard Precautions to minimize the possibility of exposure to pathogens.

● Ensure that HCWs who collect specimens wear appropriate PPE (gloves, gowns, particulate respirator, and eye protection). The specimen collection should be done in a well-ventilated single room.

● Ensure that personnel who transport specimens are trained in safe handling practices and spill decontamination procedures.

● Place specimens for transport in leak-proof specimen bags (secondary container) that have a separate sealable pocket for the specimen (i.e. a plastic biohazard specimen bag), with the patient’s label on the specimen container (primary container), and a clearly written request form

● Ensure that health-care facility laboratories adhere to appropriate biosafety practices and transport requirements according to the type of organism being handled.

● Notify the laboratory as soon as possible that the specimen is being transported.

■ Managing bodies in Mortuary: Deceased bodies may pose a potential infectious to those who handle them, either family members or body washers. Apply the following precautions 8: ● Place the body in appropriately sized body bag ● Body washing should be performed at the hospital morgue ● Morgue staff should apply Hand hygiene, gloves, particulate respirator

(e.g.N95), water resistant gown, boots/shoe cover8 (GCC-ICM-08-10) ● If family members wish to perform the body washing, they must adhere to the

same precautions above ● Ensure that the body bags (which are plastic) are appropriately disposed of

when the body is removed.

V. Admission criteria

■ Not all suspected MERS-CoV patients should be admitted to healthcare facilities. ■ Patients suspected to have MERS-CoV infection who have shortness of breath,

hypoxemia, and/or clinical or radiological evidence of pneumonia should be hospitalized.

■ Patients with suspected MERS-CoV who have no shortness of breath, hypoxemia, or evidence of pneumonia may be cared for and isolated in their home.

References:

1. MoH guidelines on MERS CoV infection control in healthcare facilities 1st edition, May 2013. ( momerodom 344378 dated 7/10/1434)

2. MoH guidelines on MERS CoV infection control in healthcare facilities 2nd edition, Feb 2014. http://www.gdipc.org/mers-cov.html

3. Infection prevention and control during health care for probable or confirmed cases of novel coronavirus (nCoV) infection, Interim guidance, 6 May 2013, http://www.who.int/csr/disease/coronavirus_infections/IPCnCoVguidance_06May13.pdf?ua=1

4. MERS-CoV infection case definition, 12 May 2014, http://www.moh.gov.sa/en/Search/Pages/Default.aspx?k=MERS

5. Infection prevention and control of epidemic- and pandemic-prone acute respiratory infections in health care, April 2014, http://www.who.int/csr/bioriskreduction/infection_control/publication/en/

6. Drosten, Christian, MERS virus kinetic data (presented during the 2rd board meeting of Mass gathering center-Riyadh April 2014, unpublished)

7. Rapid advice note on home care for patients with Middle East respiratory syndrome coronavirus (MERS-CoV) infection presenting with mild symptoms and management of contacts 8 August 2013, http://www.who.int/csr/disease/coronavirus_infections/MERS_home_care.pdf

8. Gulf Cooperation council infection control manual, 2013, GCC-ICM-08-10: http://www.gdipc.org/ic-manual.htmlhttp://www.who.int/csr/disease/coronavirus_infections/MERS_home_care.pdf

Guidelines for home isolation related to MERS Corona Virus infections

May 2014

■ Isolation is defined as the separation or restriction of activities of an ill person with a contagious disease from those who are well.

■ Before the ill person is isolated at home a healthcare professional should:

– Assess whether the home is suitable and appropriate for isolating the ill person. You can conduct this assessment by phone or direct observation.

□ The home should have a functioning bathroom. If there are multiple bathrooms, one should be designated solely for the ill person.

□ The ill person should have his or her own bed and preferably a private room for sleeping.

□ Basic amenities, such as heat, electricity, potable and hot water, sewer, and telephone access, should be available.

□ There should be a primary caregiver who can follow the healthcare provider’s instructions for medications and care. The caregiver should help the ill person with basic needs in the home and help with obtaining groceries, prescriptions, and other personal needs.

■ If the home is suitable and appropriate for home care and isolation you should give the patient, the caregiver, and household members the following instructions:

For the patient

Separate yourself from other people in your home As much as possible, you should stay in a different room from other people in your home. Also, you should use a separate bathroom, if available.

Call ahead before visiting your doctor Before your medical appointment, call the healthcare provider and tell him or her that you may have MERS-CoV infection. This will help the healthcare provider’s office take steps to keep other people from getting infected.

Wear a medical mask You should wear a medical mask when you are in the same room with other people and when you visit a healthcare provider. If you cannot wear a medical mask, the people who live with you should wear one while they are in the same room with you.

Cover your coughs and sneezes Cover your mouth and nose with a tissue when you cough or sneeze, or you can cough or sneeze into your sleeve. Throw used tissues in a lined trash can, and immediately wash your hands with soap and water or disinfect it with waterless alcohol-based hand sanitizer.

Wash your hands Wash your hands often and thoroughly with antiseptic soap and water. You can use an alcohol-based hand sanitizer if antiseptic soap and water are not available and if your hands are not visibly dirty. Avoid touching your eyes, nose, and mouth with unwashed hands.

Avoid sharing household items You should not share dishes, drinking glasses, cups, eating utensils, towels, bedding, or other items with other people in your home. After using these items, you should wash them thoroughly with soap and warm water.

For caregivers and household members

If you live with or care for someone at home who is ill and being evaluated for MERS-CoV infection, you should:

■ Make sure that you understand and can help the ill person follow the healthcare provider's instructions for medication and care. You should help the ill person with basic needs in the home and provide support for getting groceries, prescriptions, and other personal needs.

■ Have only people in the home who are essential for providing care for the ill person.

– Other household members should stay in another home or place of residence. If this is not possible, they should stay in another room, or be separated from the ill person as much as possible. Use a separate bathroom, if available.

– Restrict visitors who do not have an essential need to be in the home.

– Keep elderly people and those who have compromised immune systems or specific health conditions away from the ill person. This includes people with chronic heart, lung or kidney diseases, and diabetes.

■ Make sure that shared spaces in the home have good air flow, such as by air-conditioner or an opened window.

■ Wear a disposable medical mask, gown, and gloves when you touch or have contact with the ill person’s blood, body fluids and/or secretions, such as sweat, saliva, sputum, nasal mucous, vomit, urine, or diarrhea.

– Throw out disposable medical masks, gowns, and gloves after using them. Do not reuse.

– Wash your hands immediately after removing your medical mask, gown, and gloves.

■ Wash your hands often and thoroughly with soap and water. You can use an alcohol-based hand sanitizer if soap and water are not available and if your hands are not visibly dirty. Avoid touching your eyes, nose, and mouth with unwashed hands.

■ Avoid sharing household items. You should not share dishes, drinking glasses, cups, eating utensils, towels, bedding, or other items with an ill person who is being evaluated for MERS-CoV infection. After the ill person uses these items, you should wash them thoroughly with soap and warm water.

■ Clean all “high-touch” surfaces every day. Also, clean any surfaces that may have blood, body fluids and/or secretions on them.

– Wear disposable gloves and gown while cleaning surfaces.

– Clean frequently touched surfaces such as bedside tables, bed frame, and other bedroom furniture daily with regular household cleaners or a diluted bleach solution (1 part bleach to 99 parts water). Clean bathroom and toilet surfaces daily with regular household cleaners or a diluted bleach solution (1 part bleach to 9 parts water).

■ Wash laundry thoroughly.

– Immediately remove and wash clothes or bedding that have blood, body fluids and/or secretions on them.

– Wear disposable gloves while handling soiled items. Wash your hands immediately after removing your gloves.

– Wash the items with detergent and warm water at the maximum available cycle length then machine dry them.

■ Place all used gloves, gowns, medical masks, and other contaminated items in a lined container before disposing them with other household waste. Wash your hands immediately after handling these items.

■ Follow the guidance for close contacts below.

For close contacts including healthcare workers

If you have had close contact with someone who is ill and being evaluated for MERS-CoV infection, you should:

■ Monitor your health for 14 days, starting from the day you were last exposed to the ill person. Watch for these symptoms:

– Fever (38° C, or higher). Take your temperature twice a day.

– Coughing.

– Shortness of breath.

– Other early symptoms to watch for are chills, body aches, sore throat, headache, diarrhea, nausea/vomiting, and runny nose.

■ If you develop symptoms, follow the prevention steps described above, and call your healthcare provider as soon as possible. Before your medical appointment, call the healthcare provider and tell him or her about your possible exposure to MERS-CoV. This will help the healthcare provider’s office take steps to keep other people from getting infected. Ask your healthcare provider to call the MOH.

■ If you do not have any of the symptoms, you can continue with your daily activities, such as going to work, school, or other public areas.