Year : 2020 | Volume
: 63 | Issue : 3 | Page : 350--357
Guidelines for various laboratory sections in view of COVID-19: Recommendations from the Indian Association of Pathologists and Microbiologists
Vatsala Misra1, Ranjan Agrawal2, Harendra Kumar3, Asaranti Kar4, Usha Kini5, Aruna Poojary6, Indranil Chakrabarti7, Sharada Rai8, Anika Singhal9, S Vijay Shankar10, Jayaram N Iyengar11,
1 Pathology, MLN Medical College, Prayagraj, Uttar Pradesh, India
2 Pathology, Rohilkhand Medical College and Hospital, Bareilly, Uttar Pradesh, India
3 Pathology, SN Medical College, Agra, Uttar Pradesh, India
4 Pathology, SCB Medical College, Cuttack, Odisha, India
5 Pathology, St.John's Medical College and Oncquest Laboratories, Bengaluru, Karnataka, India
6 Pathology and Microbiology, Breach Candy Hospital Trust, Mumbai, Maharashtra, India
7 Pathology, North Bengal Medical College, West Bengal, India
8 Pathology, Kasturba Medical College, Mangalore Manipal Academy of Higher Education, Manipal, Karnataka, India
9 ESI Hospital, Noida, Uttar Pradesh, India
10 Pathology, Adichunchanagiri Institute of Medical Sciences, B G Nagara, Mandya, Karnataka, India
11 Neuberg Anand Reference Laboratory, Bengaluru, Karnataka, India
Professor, Department of Pathology, Rohilkhand Medical College and Hospital, Pilibhit Bypass Road, Bareilly - 243 006, Uttar Pradesh
Declared as a pandemic by WHO on March 11, 2020, COVID-19 has brought about a dramatic change in the working of different laboratories across the country. Diagnostic laboratories testing different types of samples play a vital role in the treatment management. Irrespective of their size, each laboratory has to follow strict biosafety guidelines. Different sections of the laboratory receive samples that are variably infectious. Each sample needs to undergo a proper and well-designed processing system so that the personnel involved are not infected and also their close contacts. It takes a huge effort so as to limit the risk of exposure of the working staff during the collection, processing, reporting or dispatching of biohazard samples. Guidelines help in preventing the laboratory staff and healthcare workers from contracting the disease which has a known human to human route of transmission and high rate of mortality. A well-knit approach is the need of the hour to combat this fast spreading disease. We anticipate that the guidelines described in this article will be useful for continuing safe work practices by all the laboratories in the country.
|How to cite this article:|
Misra V, Agrawal R, Kumar H, Kar A, Kini U, Poojary A, Chakrabarti I, Rai S, Singhal A, Shankar S V, Iyengar JN. Guidelines for various laboratory sections in view of COVID-19: Recommendations from the Indian Association of Pathologists and Microbiologists.Indian J Pathol Microbiol 2020;63:350-357
|How to cite this URL:|
Misra V, Agrawal R, Kumar H, Kar A, Kini U, Poojary A, Chakrabarti I, Rai S, Singhal A, Shankar S V, Iyengar JN. Guidelines for various laboratory sections in view of COVID-19: Recommendations from the Indian Association of Pathologists and Microbiologists. Indian J Pathol Microbiol [serial online] 2020 [cited 2021 Mar 9 ];63:350-357
Available from: https://www.ijpmonline.org/text.asp?2020/63/3/350/291693
The outbreak of a novel coronavirus disease in Wuhan, China started in November 2019. It was declared a Public Health Emergency of International Concern on 30 January 2020 by the World Health Organization (WHO). In India, the first patient was detected in Kerala on 30 January 2020. COVID-19 is the name given by WHO on 11 February 2020 for the disease caused by the novel corona virus SARS-CoV-2. It was finally declared a pandemic by WHO on March 11, 2020, and since then has suddenly changed the global health scenario due to spread to more than 200 countries worldwide. The spread occurs chiefly via the respiratory route and is transmitted through large droplets or aerosols and less commonly by contact with infected surfaces or fomites. Human-to-human transmission of SARS-Co-V-2 has been described with an incubation span ranging between 2 to 10 days. In view of the repeated exposure to potentially infectious patients and specimens, health care and laboratory personnel are highly susceptible to infection with COVID-19. Rapid spread of the virus and also regular changes in the information and parameters requires guidelines for routine laboratory practices and some for specific laboratory sections that will help in preventing the exposure to others. Safeguarding the healthcare workers in the laboratories should be the top priority. Laboratory workers in resource-limited settings should have some updated information to protect themselves from this deadly virus.
This review paper provides an assessment of the current state of knowledge about the disease, and the potential existence of the virus in different samples. It discusses the measures that laboratories should undertake to function during the pandemic, thus minimizing the risk of exposure of the laboratory personnel, trainees, and the pathologists or microbiologists. Framing of guidelines ensure not only uniformity in the working system but also as a checklist to ensure safe laboratory environment.
The reported detection rate of COVID-19 virus in different clinical samples is variable. Few authors have reported that sputum was 72% infective; bronchoalveolar lavage 93%; nasal swab 63%; pharyngeal swab 32%, fibrobronchoscopic brush sample 46%, stool samples 10.1%, serum 2.8%, conjunctival swab 1.1% and, urine 0.8%.,,,, Chen Y et al. identified SARS-CoV-2 virus in the fecal samples even few days after the pharyngeal sample turned negative, and stressed on the need to consider feco-oral route of transmission for COVID-19. Qiu L et al. have reported the absence of SARS-CoV-2 in the vaginal sample. Peritoneal fluid, even when diluted ten times, gave a positive result equivalent to that of the nasal swab indicating the high level of infectivity. Semen sample has not been found to be infective.
Centers for Disease Control and Prevention (CDC), World Health Organization (WHO), Indian Council of Medical Research (ICMR) and Ministry of Health and Family Welfare (MHFW) have been regularly issuing guidelines for laboratories during the present COVID-19 pandemic.,,,,, Small and medium sized laboratories may include hematology, cytopathology, biochemistry, microbiology and histopathology sections under one roof; whereas in Institutions and corporate labs they may be divided into individual sections. The institutional, corporate, and smaller to medium sized private laboratories vary considerably in terms of facilities and available support. Whether combined or separate, the basic guidelines remain the same and should be adhered to especially considering the known human to human transmission of the virus. When applied to laboratories and sample collection centres the guidance have been majorly sub-divided under the following heads:
- Routine laboratory precautions and biosafety guidance
- Disinfection of offices and work surface
- Cleaning of toilets and washrooms
- Laboratory waste management and sample discarding
- Care of staff and laboratory personnel
- Universal and additional PPE; guidance for use of mask
- Phlebotomy, sample collection and transportation
- Handling of requisition slips
- Hematology section
- Histopathology laboratory; frozen section; autopsy.
- Cytopathology laboratory; sample processing in cytopathology laboratory
- Biochemistry section
- Microbiology laboratory
- Remote reporting/Digital pathology
- Teaching/training in Academic Institutions.
A. Routine Laboratory Precautions& Biosafety Guidance:
- Standard precautions should be used to maintain a barrier between the specimen and personnel during all handling process. All procedures must be performed based on risk assessment and only by trained personnel as per the relevant Standard operating procedures (SOP) at all times. Investigations that are not a priority or those that do not affect the treatment modality should be deferred for the time being
- The initial processing of all specimens should take place in a validated biological safety cabinet (BSC) or primary containment device. Biosafety cabinets (BSC) are closed containment cabinets that provide a clean working environment besides preventing exposure of the laboratory personnel, contamination by aerosol, escape of the pathogenic organisms and, finally help in protecting the environment by preventing cross-contamination. There are 3 classes of BSC varying from I to III. Class I is suitable for low to moderate risk laboratory work; Class II for low to high risk while Class III maintains the maximum safety level against high risk infectious agents. Closed BSC with inflow air flow velocities of 0.45 m/s is ideal to limit the microorganisms. A 25-cm high work opening provides more protection. The exhaust air of the BSC must pass through HEPA filters before being discarded to the atmosphere and preferably never recirculated. The BSC should be turned on at least few minutes before the procedure so that the airflow is established and well-maintained 
- All technical procedures should be performed in a way that minimizes the formation of aerosols and droplets.,, The various aerosol generating procedures in the laboratory have been mentioned in [Table 1]. All aerosol generating procedures should be performed inside the Class II BSC
- To avoid the formation of aerosols, centrifugation should be performed using sealed centrifuge rotors and placing the samples in sealed cups. These rotors or cups should be loaded and unloaded in a BSC. Following centrifugation the machine should be rested for at least 5 minutes, followed by gently unlocking the lid and cautiously opening the sample caps. This allows any droplets formed during centrifugation to settle down 
- Pipetting by mouth suction must be strictly forbidden
- Needles should not be recapped and always be collected in puncture-proof sharps containers fitted with covers ,
- Biohazard containers must be available for appropriate disposal of contaminated materials and should be located in the immediate vicinity of the working area. Separate color coded bins (foot-operated) with bags should be available. All infectious/suspected materials should be discarded in a yellow bag or bin labeled with biomedical hazard sticker and additionally written as COVID-19 so that extra care can be taken while handling. As a precaution, double-layered leak-proof bags should be used for collection of waste from high risk areas
- Eating, drinking, smoking, applying cosmetics and handling of contact lenses should be prohibited while working in the laboratory
- Entire laboratory and the designated work area should be regularly disinfected using proper disinfectants. [Choice of disinfectants is mentioned in Section E below]
- Safe packaging and transport of samples to reference laboratories or to an outsourced center is extremely important to prevent infections among the lab personnel handling these samples. Patient's specimens from suspected or confirmed cases should be transported as UN3373 'Biological Substance Category B'. Viral study samples should be transported as category A, UN2814, Infectious substance, affecting humans, according to WHO Biosafety guidelines GMPP 
- Only one attendant per patient should be allowed during any procedure. In the waiting area the chairs or benches should be at a considerable distance from each other and no crowding should be allowed. The patient and the attendant both should be educated to wear face masks and follow 'physical distancing'. A dedicated hand-wash sink should be available in the laboratory
- The rooms should be well and adequately ventilated by keeping the windows slightly open or switching on any nearby exhaust fan. Use of desert (evaporating) coolers can also be used during summers. The coolers must draw outside air with maintenance of cross – ventilation and humidity should be reduced by opening the windows. Another important point is good air distribution i.e., providing uniform ventilation rate at low air velocity within all points in the room. Constant inward directional airflow in the laboratory should be there
- Air conditioners can be used keeping in mind some important guidelines. The temperature should be regulated between 24°C and 30°C; 24°C for humid and 30°C for dry climate. The recommended humidity should be between 40-70%. In dry climate, where humidity is less, it is recommended to increase the humidity by keeping water in a shallow pan. The filters should be cleaned more frequently than normally. Window air-conditioners are alright. With central air-conditioning proper ventilation with outdoor air is strongly recommended. The amount of fresh air needed per person is directly proportional to the occupancy level. In high occupancy areas, it may be 10 L/S per person while in less occupancy it would be 20 L/S per person. So, it is important to reduce the occupancy density
- For exhaust from high risk areas, the exhaust air should be let off into the atmosphere via an outlet pipe facing upwards at a height of 3 cm above the tallest point of the building. HEPA filter should be installed at the primary point of air extraction. Chemical disinfection of the exhaust air can be done especially from the COVID-19 patient areas by bubbling the exhaust air through a tank filled with 1% sodium hypochlorite solution 
- Care of equipment is important. The external surface of all analyzers should be disinfected regularly especially the frequently touched areas. Shared microscopes should be properly wiped using alcohol solutions.
B. Disinfection of Offices & Work Surface:
- High contact surfaces such as railings, door handles, call buttons, lift buttons, escalator handrails, public counters, intercom systems, chairs, office stationeries, equipment including telephones, printers, scanners, keyboards, mouse, mouse pad, earphones, tea or coffee dispensing machines and other office machines should be cleaned twice daily by mopping with a linen or absorbable cloth soaked in 1% Sodium hypochlorite or Alcohol based solutions. All metallic surfaces like door handles, security locks, keys etc., should be decontaminated using 70% alcohol 
- Hand sanitizing stations should be installed in the office or laboratory premises, especially at the entry gate and exit point of high contact surfaces. Personnel must wash their hands often, especially after handling infectious materials and experimental animals, before leaving the laboratory working areas, and before eating. The dictum to be followed should be “Five Moments of Hand Hygiene” as recommended by WHO. The 'My 5 Moments for Hand Hygiene' approach defines the importance of hand hygiene for the health-care workers. These should be performed – before touching a patient, before clean or aseptic procedures, after body fluid exposure or risk, after touching a patient, and after touching patient surroundings 
- The surfaces of working areas must be decontaminated after any spill of potentially dangerous material and at the end of the batch or entire day's work. The contaminated surfaces should be cleaned using 1% Sodium hypochlorite solution. In case a blood spillage has occurred then the area must immediately be mopped with an absorbent material to reduce the organic load, followed by discard in yellow bag and then disinfected with 1% sodium hypochlorite solution which should be left in place for a longer duration. Later the area should be mopped dry.
C. Cleaning of Toilets & Washrooms/Public utilities:
Toilets are an integral part of the laboratory not only for the working staff but also for the patients.
- Sanitary workers must use different set of cleaning equipment such as mops and nylon scrubber separately for wash basins and commodes. The toilet pot, commode, especially the lid, should be cleaned with soap water using a long handle angular brush and disinfected with 1% Sodium hypochlorite. The personnel should always wear disposable protective gloves while cleaning
- Before flushing care should be taken to close the lid and then flush so as to prevent aerosol formation
- The sink and the toilet floor should be washed using soap powder or detergent. For disinfection 1% Sodium hypochlorite is preferred which should be left undisturbed for at least 20 minutes before reuse
- The taps and fittings should be rinsed with warm water and detergent powder using nylon scrubber and finally to be disinfected with hypochlorite solution. The preferred disinfectant for metallic or coated fittings is 70% alcohol. Care should be taken to clean the underside of taps and fittings. It is always preferable to use liquid soap instead of soap bars.
D. Laboratory Waste Management and sample discarding:
All the laboratory waste generated after testing samples from suspected or confirmed COVID-19 patients must be handled as per the special waste management guidelines for COVID-19.
- There should be dedicated sanitation workers for handling laboratory wastes. These workers should be provided with adequate Personal protective equipment (PPE) including three layer masks, splash proof aprons or gowns, nitrile gloves, gum boots and safety goggles. They should be provided with adequate training for sanitization, collection of biomedical waste and, precautionary measures to handle such waste 
- The biomedical waste and general waste should be segregated at the point of generation and not in the collection or storage area so as to maintain complete safety. The general laboratory wastes should be collected separately as per the existing biomedical waste management (BMW) guidelines. The wet and dry solid waste bags should be tightly tied so as to prevent any leakage and sprayed with sodium-hypochlorite solution before handing over to the sanitary workers. For wet wastes, bags that can be subjected to composting should be used
- The bags used for collection of waste from COVID-19 patients should be double layered ensuring adequate strength and prevention of leakages. Biomedical waste should be collected and stored separately in a temporary storage room and shifted directly into the BMW collection van 
- Dedicated trolleys, collection bins and vehicles labeled as “COVID-19” must be used for the collection, disposal and, priority treatment of all laboratory waste. The vehicles and the inner and outer surface of containers, bins and, trolleys used for storage of COVID-19 waste should be disinfected after each collection using hypochlorite solution.
- The types of disinfectant as well as the contact time both are important during the disinfection process. The dilution amount, technique, shelf-life and the expiry date of the chemical play a vital role. Disinfectants that have been proved to have a definite activity against the enveloped viruses' especially the respiratory types should be preferred. A wide range of chemicals are available that can be used as disinfectants
- For small surfaces 62–71% Ethanol, while for bigger areas 0.5% Hydrogen peroxide, or 0.1-1% Sodium hypochlorite should be used. Only freshly prepared Sodium hypochlorite should be used. The disinfectant solution should be applied for at least 30 minutes. 0.05-0.2% Benzalkonium chloride or 0.02% Chlorhexidine digluconate are also disinfectants but are less effective., Bleach solution should be used for cleaning floors.
F. Care of Staff and Laboratory Personnel:
Staff is the backbone of any laboratory. They need to do phlebotomy, transport the collected samples and, process them for reporting by the concerned Doctor. Care of the staff is more important than any other work. In this regard it is recommended that-
- Staffing should be restricted to a minimum. Only trained staff should be placed on duty so as to avoid any spillages or mishap. Routine wearing of lab apron prevents contamination of the personal clothing. First aid kit should be made available in each section of the laboratory
- Frequent hygiene including hand wash and hand rub should be encouraged 
- Appropriate use of PPE is important for laboratory professionals and should be based on risk assessment (The details are mentioned under section G below). The donning and doffing of PPE should have dedicated space and preferably separate from the workspace. Doffing is the most contaminated process and must be performed in a negative pressure room. Those personnel working with high risk procedures must preferably take a shower after doffing. PPE must be removed only at the time of finally leaving the laboratory and disposed in appropriate biomedical waste bins. All PPE must be changed as per doffing guidelines and hand hygiene should be performed even in between the doffing process 
- Avoid touching of eyes, mouth, and nose or face until the hands are washed
- All laboratory personnel working with samples from suspected or confirmed COVID-19 patients should immediately report development of any symptoms resembling those of COVID-19 patient to their concerned medical authorities. Extra precautions should be taken for staff who are elderly, or have history of cardiovascular disease, diabetes mellitus, chronic respiratory problem, cancer are immunocompromised or on chemo or radiotherapy.,
G. 1. Universal and additional PPE:
- PPE should be worn based on the risk assessment for aerosol generating procedures and not for routine processes in the laboratory. PPE should comprise of laboratory coat, surgical masks, face shields, surgical cap and gloves. For aerosol generating procedures, a fluid impervious gown or coveralls, double gloves, proper masks, head cover, leggings or shoe covers, goggles and face shield should be used. Whole-body suit should be used for high risk works. Alternatively, solid-front or wrap-around waterproof gowns with coveralls having sleeves that fully cover the forearms (typically a surgical gown) may be used
- Double layer of Nitrile or non-porous gloves should ideally be used. Wearing of rubber boots, dedicated shoes or disposable shoe covers are important, especially when collecting samples from the isolation wards.
G. 2. Guidance for use of mask:
- The type of mask would depend on the risk of aerosol generation activities being undertaken. A triple layer surgical mask is sufficient for all non-aerosol generating processes. N95 or FFP2 are usually tight fit masks and must be used when performing aerosol generating procedures
- The mask should not be allowed to hang from the neck. They should be changed after 6 hours or as soon as they become wet or moist. Disposable masks should never to be reused and must be discarded immediately after use in the closed yellow bin considering them as potentially infected medical waste.
H. Phlebotomy, Sample collection and transportation:
- SOP manuals for collection, transportation and processing of samples from suspected or confirmed patients of COVID-19 should be prepared in all the laboratories based on the risk of aerosol generation. The existing SOPs must be modified or supplemented accordingly
- Specific guidance on handling blood and urine samples should be followed as potentially infective, especially when the status of patient is not known
- The phlebotomy area should be separate from the main laboratory or testing area. Ideally, phlebotomy chairs should be sanitized after every use. Since phlebotomy is not an aerosol generating procedure, appropriate PPE may include laboratory coats, recommended masks face shield and gloves. Gloves should be changed after each patient is sampled. All Good Laboratory Practices such as proper hand washing and use of protective measures should be strictly followed 
- It is preferable to use disposable tourniquet with every collection or else the tourniquet should be sanitized after each use
- Only vacutainers must be used for blood collection and opening them must be carried out in the designated biosafety cabinets
- When samples are being transported they should be packed in triple layer: using primary container, secondary container and zip lock pouches. The collected samples should be placed in leak-proof bags followed by secondary containers to minimize any chances of breakage or spillage. The patient's label should be pasted on the primary container. A vaccine or ice box type container should be used for transportation of these samples. The outer container should be disinfected, both at the time of packing as well as before taking them out of the transportation box during testing
- All specimens should be delivered manually whenever possible. Pneumatic-tube systems to transport specimens should not be used in the present scenario. The laboratory should be notified as soon as possible about the specimen being transported to avoid any processing delay
- Laboratories that cannot meet the above biosafety guidelines should transfer or outsource their samples to regional, national or international reference laboratories dealing with testing of COVID-19 samples.
I. Handling of Requisition slips:
- The requisition forms should not be packed or rolled up along with the samples. They should be placed in a separate zip lock pouch to avoid cross-contamination or spillage from any leakage of the sample containers
- In case the hospital has Hospital Information System, then electronic forms or else requisition forms via email can be received. Another alternative is to dedicate a printer cum scanner and get a Xerox copy of the original requisition form for laboratory use. The original form can be disinfected by UV rays or baking in an oven at 60-65°C for 15-30 minutes.
J. Hematology Section:
- Use of hematology analyzers should be encouraged during COVID-19
- It is always advisable to use vacutainers only and opening them should be avoided as much as possible. Manual preparation of blood smears should be discouraged. If EDTA vial needs to be opened for making smears, they should be opened in a BSC and with all safety precautions. The smears should be left to dry naturally without blowing air or drying under the fan thus preventing aerosol formation
- Subsequently, the working surface should be properly disinfected as other surfaces
- Two tubes of 1% Hypochlorite solution should be run before shutting down the hematology analyzer.
K. 1. Histopathology Laboratory:
- Histopathology specimens should be properly fixed in 10% buffered formalin or Glutaraldehyde. Both these are reported to decrease the infectivity of coronavirus in a temperature and time dependent manner. Formalin inactivates the virus in a contact time of 24 hours if specimens are kept at a temperature of 37°C; at temperature of 56 °C for 90 min, 67 °C for 60 min, or 75 °C for 30 min. Glutaraldehyde fixation requires 2 days for inactivating the virus ,
- Larger specimens should be sliced and then dipped in formalin. The level of formalin should be in the formalin: tissue ratio of at least 10:1. The histopathology specimens should be placed in a leak proof container. It is preferred to have double or secondary containers i.e., container within a bigger container. Biohazard label should be pasted on all specimen containers. The outer surface of all specimen containers must be thoroughly decontaminated using alcohol or Hypochlorite solutions before processing them. During grossing, it is preferable to use blunt or round end scissors rather than pointed end ones 
- Paraffin-embedded blocks carry a low risk of infectivity. Filing of paraffin blocks and glass slides should be done with caution
- Remote reporting or use of digital pathology especially in the present situation should be envisaged.
K. 2. Frozen Section:
- The use of fresh-frozen sections should be restricted to a strict necessity basis, as cryostat disinfection takes a long time and many laboratories have only one cryostat machine available. Only single personnel should operate the cryostat and wear protective gears including goggles, N95 mask and face shield
- Immediately after the frozen section is prepared, the remaining tissue should be placed in formalin for fixation and routine processing. The cryostat and the grossing station should be thoroughly disinfected using 70% Alcohol solutions. UV rays may also be used for smaller areas.
K. 3. Autopsy:
Even with the greatest of precautions undertaken the risk of workers coming in direct contact with the infected parts, organs, fluids or secretions remains very high. Death due to COVID-19 is a non-medico-legal case and so no medico-legal autopsy is required. Non-invasive autopsy technique should be adopted., All cases whether confirmed to be COVID-19 positive or not should be labeled as suspected cases and autopsy should be planned accordingly
- The autopsy room should preferably have an exhaust fan to create negative pressure as against the surrounding. The door should always remain closed
- The number of personnel working in the autopsy room or working on the human body at any given time should be limited to the bare minimum. Three personnel including a pathologist, trained technician and an assistant are sufficient enough in the room. Ideally, the same person who shifts the body to the autopsy room should also assist in the autopsy procedure. Only one personnel should work in the body cavity in a given case. Full PPE should be worn by all personnel present in the area. A logbook including names, date and activities of all personnel either performing the autopsy or cleaning the room should be properly maintained
- Use of oscillating bone saw should be avoided or else it should be attached to a vacuum shroud to limit the formation of aerosol. Hand shears as an alternative cutting tool may be preferred
- Embalming should not be done or, if mandatory then should be done using minimal invasive technique
- Use of round or blunt end scissors should be preferred rather than sharp end ones so as to avoid any injury
- Materials or clothing for laundry should be removed from the autopsy room in a sturdy, leak-proof biohazard bag that is tightly closed and not reopened. These materials should then be sent for laundering as per the routine procedure ,
- Cleaning with soap and water followed by disinfection of the transfer trolley, autopsy table, floor and the surroundings should be carried out using 1% Sodium hypochlorite.
L. 1. Cytopathology laboratory:
- The number of fine needle aspiration cytology (FNAC) should be restricted to bare minimum and should be advised only if it truly alters the medical management of the patient. All respiratory specimens such as broncho-alveolar lavages, bronchial brushings, sputum, pleural fluids, EBUS-guided FNAs, touch imprint slides from lung core biopsies, and any specimen from suspected or known COVID-19 patients should be considered as high-risk specimens ,,
- Patients who come for FNA should wear a mask. They should also be counseled to avoid coughing during the entire procedure. The procedure should be deferred if the patient is uncooperative
- After aspiration, the material should be gently expelled and smearing should be made cautiously (preferably in a closed cabinet). While making a smear it is recommended that slides are held as far as possible from the personnel
- Drying of the smears by shaking or blowing of air should not be done as it can lead to generation of aerosol and small droplets. Air-drying of the smears should be ideally performed in class II biosafety cabinets
- The surface top should be cleaned using disinfectant after every smear preparation
- Rapid onsite evaluation (ROSE) is an important measure to ensure the adequacy of specimens. However, in the present scenario it should be deferred. If ROSE is inevitable, it should be performed using appropriate PPE ,
- The used needles should be discarded in sharp-resistant puncture proof covered waste containers
- Remote reporting and use of digital pathology especially in the present situation should be encouraged.
L. 2. Sample processing in the cytopathology laboratory:
- Cytopreparatory steps performed by technicians leading to aerosol or droplet formation such as opening of containers and removing the caps of the tubes, blending, diluting, vigorous shaking or mixing of fluids, centrifugation and, discarding the supernatant should be performed in a class II BSC.,
- The samples should be collected in properly labeled, tightly-capped, sterile tubes or containers and sent to the cytopathology laboratory in a secondary zip-lock bag and finally transported in a leak-proof cryobox. Fresh, unfixed specimens should be transported by hand, and not via the pneumatic-tube system.
- Cytology samples should preferably be fixed in alcohol-based fixatives (with alcohol concentration more than 70%) or formalin. The fixatives used for the high-risk cases should be discarded daily.
M. Biochemistry section:
- It is preferable to use fully automated instruments and Analyzers
- Splashing, agitation or leaking of the samples should be avoided. As mentioned earlier after centrifugation, the sample tubes should be made to rest for at least 5 minutes allowing the droplets to settle down. The tubes should ideally be opened in level 2 biosafety cabinets after taking appropriate precautions.
N. Microbiology laboratory:
Microbiology processing and testing is considered under high risk category. Routine microbiology services should be continued with all work performed inside a biosafety cabinet Class IIA (person and product protection) using appropriate PPE (long sleeved laboratory coats, gloves, recommended masks and face shield). Molecular microbiology (RT PCR) services require a dedicated team and strict use of full PPE. Propagative investigations such as neutralization assays or culture of virus should be carried out in a containment laboratory that has inward flow of air i.e., BSL-3.
O. Remote reporting/Digital pathology:
The risk of contracting infection can be minimized by the use of digital pathology or remote reporting. However, remote reporting may pose challenges with regard to the primary diagnosis or use of immunohistochemistry and other ancillary techniques that may carry problem of accuracy. At times, it is important to clearly mention that the case can be reported digitally or that it needs a glass slide viewing. All urgent cases can thus be taken care of by using digital or remote reporting system.
P. Teaching/Training in Academic Institutions:
Teaching, training or demonstrations in very small groups maintaining adequate physical distancing can be carried out. As mentioned earlier the microscopes after sharing should be sanitized using alcohol solutions. Use of decahead microscopes should be limited to two or three people to maintain an adequate distance. Ideally, self-study should be encouraged. If required, online training or teaching via any app can be conducted for larger groups.
Laboratory tests are a must for diagnosing any disease. Prevention of spread of the disease amongst the health care workers is also important. Safeguarding of the healthcare workers in the laboratories is of top priority. Each laboratory should asses their risk category and then reframe their working methods and the existing SOPs to ensure safety of their personnel. Adopting standard precautions along with maintaining a good personal hygiene, proper physical distancing, safe handling of laboratory samples, appropriate use of personal protective equipment and in the correct method, proper biomedical waste disposal and avoiding all short cuts can reduce the risk of transmitting COVID-19 to the laboratory personnel. Implementation of digital technology can hold important role in teaching, reporting as well as in sharing of knowledge.
Financial support and sponsorship
Conflicts of interest
There are no conflicts of interest.
|1||World Health Organization. Available from: https://www.who.int/dg/speeches/detail/who – director – general – s – opening – remarks – at – the – media – briefing –on – covid-19 ---11-march – 2020. World Health Organization 11 March 2020. Retrieved 2020 Mar 11.|
|2||Henwood A. A Survival Guide for Laboratory Professionals. Scotts Valley, CA, USA: Amazon Create Space Independent Publishing Platform; 2019. Chapter 18 Disinfection. p. 149–55.|
|3||Ahmed SS, Alp E, Ulu-Kilic A, Doganay M. Establishing molecular microbiology facilities in developing countries. J Infect Public Health 2015;8:513-25.|
|4||Wang W, Xu Y, Gao R, Lu R, Han K, Wu G, et al. Detection of COVID-19 in different type of clinical specimens. JAMA 2020;323:1843-4.|
|5||Kim J, Kim H, Lee E, Jo H, Yoon Y, Lee N et al. Detection and isolation of SARS-CoV-2 in serum, urine and stool specimens of COVID-19 patients from the Republic of Korea. Osong Public Health Res Perspect 2020;11:112–7.|
|6||Chen Y, Chen L, Deng Q, Zhang G, Wu K, Ni L, et al. The presence of SARS-CoV-2 RNA in the feces of COVID-19 patients. J Med Virol 2020;92:833–40.|
|7||Pan Y, Zhang D, Yang P, Poon LLM, Wang Q. Viral load of SARS-CoV-2 in clinical samples. Lancet Infect Dis 2020;20:411-2.|
|8||Qiu L, Liu X, Xiao M, Xie J, Cao W, Liu Z, et al. SARS-CoV-2 is not detectable in the vaginal fluid of women with severe COVID-19 infection. Clin Infect Dis 2020;ciaa375. doi: 10.1093/cid/ciaa375.|
|9||Coccolini F, Tartagha D, Puglisi A, Giordano C, Pistello M, Lodato M, et al. SARS CoV-2 is present in peritoneal fluid in COVID-19 patients. Ann Surg 2020 (Accepted for publication).|
|10||Centers for Disease Control and Prevention. Laboratory biosafety guidelines for handling and processing specimens associated with SARSCoV. Available from: https://www.cdc.gov/sars/guidance/f-lab/app5.html. [Last accessed on 2020 Mar 23].|
|11||World Health Organization & WHO Patient Safety. (2009). WHO guidelines on hand hygiene in health care. World Health Organization. Available from: https://apps.who.int/iris/handle/10665/44102. [Last accessed on 2009 Feb 26].|
|12||Ministry of Health and Family Welfare. Government of India. COVID-19 India, as on 14th April 2020. Available from: http://www.mohfw.gov.in.|
|13||World Health Organization. Laboratory biosafety guidance related to the novel coronavirus (2019-nCoV). Interim guidance. Available from: https://www.who.int/docs/default-source/coronaviruse/laboratory-biosafety-novel-coronavirus-version-1-1.pdf. [Last accessed on 2020 Jul 16].|
|14||Indian Council of Medical Research. https://main.icmr.nic.in/content/covid-19. New Delhi: ICMR; 2020.|
|15||Interim Laboratory Biosafety Guidelines for Handling and Processing Specimens Associated with Coronavirus Disease 2019 (COVID-19). Available from: https://www.cdc.gov/coronavirus/2019-nCoV/lab/lab-biosafety-guidelines.html. [Last accessed on 2020 Jul 20].|
|16||Centers for Disease Control and Prevention (CDC). Interim laboratory biosafety guidelines for handling and processing specimens associated with coronavirus disease 2019 (COVID-19). Available from: https://www.cdc.gov/coronavirus/2019-nCoV/lab/lab-biosafety-guidelines.html. [Last accessed on 2020 Mar 20].|
|17||World Health Organization. Laboratory biosafety guidance related to the novel coronavirus (2019-nCoV). Interim guidance 13 May 2020. Available from: https://www.who.int/publications/i/item/laboratory-biosafety-guidance-related-to-coronavirus- disease-(covid-19). [Last accessed on 2020 Jul 01].|
|18||Tan SS, Yan B, Saw S, Lee CK, Chong AT, Jureen R, et al. Practical laboratory considerations amidst the COVID-19 outbreak: Early experience from Singapore. J Clin Pathol 2020. doi: 10.1136/jclinpath-2020-206563.|
|19||Laboratory biosafety manual: Third edition. Geneva: World Health Organization; 2004. Available from: https://www.who.int/csr/resources/publications/biosafety/Biosafety7.pdf?ua=1. [Last accessed on 2020 Apr 06].|
|20||ISHRAE COVID-19 Guidance document for Air conditioning and ventilation. Released 13 April 2020.|
|21||VanDoremalen N, Bushmaker T, Morris DH, Holbrook MG, Gamble A, Williamson BA, et al. Aerosol and surface stability of SARS- CoV-2 as compared with SARS-CoV-1. N Engl J Med 2020;382:1564-7.|
|22||Central Pollution Control Board guidelines. Available from: https://cpcb.nic.in/uploads/Projects/Bio-Medical-Waste/BMW-GUIDELINES-COVID.pdf. Guidelines for Handling, Treatment, and Disposal of Waste Generated during Treatment/Diagnosis/Quarantine of COVID-19 Patients – Rev. 1. [Last accessed on 2020 Mar 24].|
|23||Duan SM, Zhao XS, Wen RF, Huang JJ, Pi GH, Zhang SX, et al. Stability of SARS coronavirus in human specimens and environment and its sensitivity to heating and UV irradiation. Biomed Environ Sci 2003;16:246–55.|
|24||Kampf G, Todt D, Pfaender S, Steinmann E. Persistence of coronaviruses on inanimate surfaces and its inactivation with biocidal agents. J Hosp Infect 2020;104:246-51.|
|25||Personal protective equipment (PPE) needs in healthcare settings for the care of patients with suspected or confirmed novel coronavirus (2019-nCoV). ECDC Technical report. February 2020. Available from: https://www.ecdc.europa.eu/sites/default/files/documents/novel-coronavirus-personal-protective-equipment-needs-healthcare- settings.pdf. [Last accessed on 2020 Jul 03].|
|26||Chen N, Zhou M, Dong X, Qu J, Gong F, Han Y, et al. Epidemiological and clinical characteristics of 99 cases of 2019 novel corona virus pneumonia in Wuhan, China: A descriptive study. Lancet 2020;395:507-13.|
|27||Gupta N, Agrawal S, Ish P, Mishra S, Gaind R, Usha G, et al. Clinical and epidemiological profile of the initial COVID-19 patients at a tertiary care centre in India. Monaldi Arch Chest Dis 2020;90. doi: 10.4081/monaldi. 2020.1294.|
|28||Srinivasan R, Gupta P, Rekhi B, Deb P, Nijhawan VS, Prasoon D, et al. Indian academy of cytologists national guidelines for cytopathology laboratories for handling suspected and positive COVID-19 (SARS-COV-2) patient samples. J Cytol 2020;37:67-71.|
|29||Henwood AF. Corona virus disinfection in histopathology. J Histotechnol 2020;43:102-4.|
|30||Williams BJ, Brettle D, Aslam M, Barrett P, Bryson G, Cross S, et al. Guidance for remote reporting of digital pathology slides during periods of exceptional service pressure: An emergency response from the UK Royal College of Pathologists. J Pathol Inform 2020;11:12.|
|31||Hanley B, Lucas SB, Youd E, Swift B, Osborn M. Autopsy in suspected COVID-19 cases. J Clin Pathol 2020;73:239-42.|
|32||Indian Council of Medical Research. Standard Guidelines for Medico-Legal Autopsy in COVID-19 Deaths in India. 1st ed. New Delhi: ICMR; 2020.|
|33||Pambuccian SE. The COVID-19 pandemic: Implications for the cytology laboratory. J Am Soc Cytopathol 2020;9:202-11.|
|34||Cytopathology Laboratory Considerations during the COVID-19 Pandemic: College of American Pathologists Cytopathology Committee. Available from: https://www.cap.org/laboratory-improvement/news-and-updates. [Last accessed on 2020 Jul 20].|