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Coronavirus Illness 2019 (COVID-19)


Background

Health workers, coroners, and pathologists ought to instantly notify their nativeexterior icon or stateexterior icon well being division within the occasion of the identification of a deceased particular person with confirmed or suspected COVID-19.

This doc supplies particular interim suggestions for the gathering and submission of postmortem specimens from deceased individuals with confirmed or suspected COVID-19 .  This interim steerage relies on what’s at present identified about coronavirus illness 2019 (COVID-19), together with what is understood concerning how SARS-CoV-2 spreads.

This doc additionally supplies suggestions for biosafety and an infection management practices throughout specimen assortment and dealing with, together with throughout post-mortem procedures. The steerage can be utilized by health workers, coroners, pathologists, different employees concerned in offering postmortem care, and state, tribal, native, and territorial well being departments. Within the healthcare setting, the time period “aerosol” is used with respect to aerosol-generating procedures (AGP) that produce small droplets and particles and require distinct engineering controls to stop occupational transmission of infectious pathogens like SARS-CoV-2. Postmortem actions must be carried out with a concentrate on avoiding AGPs and, if aerosol era is probably going (e.g., when utilizing an oscillating noticed), making certain that applicable engineering controls and private protecting tools (PPE) are used. These precautions and using Commonplace Precautions are  applicable work practices to assist stop direct contact with infectious materials, percutaneous damage, and different hazards associated to shifting human stays and dealing with embalming chemical substances.

Health workers, coroners, and different healthcare professionals ought to use skilled judgment to find out if a decedent had indicators and signs suitable with COVID-19 throughout life and whether or not postmortem testing is important. Many sufferers with confirmed COVID-19 have developed fever and/or signs of acute respiratory sickness (e.g., fever, cough, problem respiratory). There are epidemiologic elements which will additionally assist information choices about testing for SARS-CoV-2, comparable to documented COVID-19 in a jurisdiction, identified group transmission, contact with a identified COVID-19 affected person, or being part of a cluster of respiratory sickness in a closed setting (e.g., a long-term care facility). Testing for different causes of respiratory sickness (e.g., influenza) is strongly inspired, see Data for Clinicians on Influenza Virus Testing.

Really useful Postmortem Specimens and Testing

Suggestions about the kind of postmortem specimens to gather range primarily based on whether or not the case of COVID-19 is suspected or confirmed, in addition to whether or not an post-mortem is carried out. The next elements must be thought-about when figuring out if an post-mortem might be carried out for a deceased particular person with confirmed or suspected COVID-19:

The next elements must be thought-about when figuring out if an post-mortem might be carried out for a deceased particular person with confirmed or suspected COVID-19:

  • Medicolegal jurisdiction
  • Facility environmental controls
  • Availability of beneficial PPE
  • Household and cultural needs

If an post-mortem is carried out for a suspected COVID-19 case, assortment of the next postmortem specimens and efficiency of the next testing are beneficial:

  • Postmortem swab specimens for SARS-CoV-2 testing:
    • Specimens:
      • Higher respiratory tract swab: Nasopharyngeal Swab (NP swab)
      • Decrease respiratory tract swab: Lung swab from every lung
    • Testing:
      • Reverse transcription-polymerase chain response (RT-PCR) stays the “gold normal” for medical diagnostic detection of SARS-CoV-2.
  • Postmortem swab specimens for testing of influenza viruses and different respiratory pathogens. For extra info on influenza testing strategies, please discuss with Data for Clinicians on Influenza Virus Testing.
    • Assortment of separate swabs might be wanted if multiplex assays for the simultaneous detection of SARS-CoV-2, influenza viruses, and different respiratory pathogens aren’t accessible. Work with public well being or medical laboratories to find out what sort of testing is offered.
  • Different postmortem microbiologic and infectious illness testing, as indicated.
  • Formalin-fixed post-mortem tissues from lung, higher airway and different main organs (e.g., coronary heart, liver, kidney). Submission of mounted post-mortem tissues to CDC for SARS-CoV-2 testing could also be indicated in some eventualities.

If an post-mortem is NOT carried out for a suspected COVID-19 case, assortment of the next postmortem specimens and efficiency of the next testing are beneficial:

  • Postmortem NP swab specimen for SARS-CoV-2 testing
    • RT-PCR stays the “gold normal” for medical diagnostic detection of SARS-CoV-2.
  • Postmortem swab specimens for testing for influenza viruses and different respiratory pathogens. For extra info on influenza testing strategies, please discuss with Data for Clinicians on Influenza Virus Testing.
    • Assortment of separate swabs might be wanted if multiplex assays for the simultaneous detection of SARS-CoV-2, influenza viruses, and different respiratory pathogens aren’t accessible.

If an post-mortem is carried out for a confirmed COVID-19 case, assortment of the next postmortem specimens must be thought-about:

  • Postmortem swab specimens for testing for influenza viruses and different respiratory pathogens. For extra info on influenza testing strategies, please discuss with Data for Clinicians on Influenza Virus Testing.
  • Different postmortem microbiologic and infectious illness testing, as indicated.
  • Formalin-fixed post-mortem tissues from lung, higher airway and different main organs (e.g., coronary heart, liver, kidney). Submission of mounted post-mortem tissues to CDC for SARS-CoV-2 testing could also be indicated in some eventualities.

Along with postmortem specimens, any remaining specimens (e.g., NP swab, sputum, bronchoalveolar lavage) which will have been collected previous to loss of life must be retained. Please discuss with Interim Tips for Amassing, Dealing with, and Testing Scientific Specimens for COVID-19 for extra info.

Really useful Biosafety and An infection Management Practices

Biosafety is vital for personnel who’re involved with human stays with confirmed or suspected COVID-19, or different infectious ailments. A site-specific threat evaluation must be accomplished earlier than conducting any procedures. Protecting measures have to be primarily based on personnel’s function-specific duties.

OSHA recommends strict adherence to fundamental security procedures used for any post-mortem on human stays. Please see OSHA’s Interim Steering for Staff and Employers at Elevated Danger of Occupational Publicityexterior icon.

Assortment of Postmortem Nasopharyngeal Swab (NP Swab) Specimens Solely

Directions on this part apply if solely postmortem NP swabs are being collected from a deceased particular person with confirmed or suspected COVID-19.

If a postmortem NP swab is being collected, solely these personnel who’re acquiring the specimen must be within the room. Personnel ought to observe Commonplace Precautions. Along with Commonplace Precautions, the next are beneficial:

Engineering Management Suggestions for NP Swab Assortment

As a result of assortment of NP swab specimens from deceased individuals is not going to induce coughing or sneezing, a destructive strain room is not required. Personnel ought to at all times adhere to Commonplace Precautions as described beforehand.

PPE Suggestions for NP Swab Assortment

If solely a NP swab is being collected, a N95 respirator or higher-level respirator is not required as a result of assortment of NP swab specimens from deceased individuals is not going to induce coughing or sneezing.

At a minimal, the next PPE must be worn:

  • Nonsterile, nitrile, latex, or rubber gloves when dealing with probably infectious supplies.
  • Heavy-duty gloves worn over the nitrile gloves if there’s a threat of cuts, puncture wounds, or different accidents which will break the pores and skin.
  • Lengthy-sleeved fluid-resistant or impermeable hospital isolation robe to guard pores and skin and clothes.
  • Plastic face protect; or a face masks and goggles to guard the face, eyes, nostril, and mouth from splashes of probably infectious bodily fluids.

For extra info on PPE, go to Utilizing Private Protecting Gear (PPE), Private Protecting Gear: Questions and Solutions, and Respirator Match Testingpdf icon.

Post-mortem Precautions and Procedures

Personnel who’ve contact with human stays, together with these performing post-mortem and amassing or dealing with specimens, are in danger for publicity to infectious brokers, comparable to SARS-CoV-2, that could be current in tissues, blood, and different bodily fluids of the deceased particular person. Moreover, personnel may be uncovered to residual floor contamination. Post-mortem must be undertaken by utilizing applicable biosafety measures and procedures. All post-mortem services ought to have written biosafety insurance policies, site-specific threat assessments, and procedures, and all collaborating personnel ought to obtain prior coaching in insurance policies and procedures.

To stop or restrict exposures, Commonplace Precautions, Contact Precautions, and Airborne Precautions with eye safety (goggles or a face protect) must be adopted throughout post-mortem. Most of the following procedures are in keeping with current tips for protected work practices within the post-mortem setting; see Tips for Secure Work Practices in Human and Animal Medical Diagnostic Laboratories:

  • Post-mortem room should have a precautionary signal posted on the entry door (e.g., “Post-mortem in Progress”, “Approved Personnel Solely”, “SARS-CoV-2 Consciousness”, “Correct PPE Required”).
  • Personnel should put on applicable PPE.
  • Variety of personnel working within the post-mortem suite and on the human physique must be restricted to the minimal variety of folks mandatory to soundly conduct the post-mortem.
  • Use a biosafety cupboard Class II or greater for the dealing with and examination of specimens and different containment tools at any time when doable.
  • AGPs comparable to use of an oscillating bone noticed must be prevented for confirmed or suspected COVID-19 instances. Think about using hand shears instead slicing instrument. If an oscillating noticed is used, connect a vacuum shroud to comprise aerosols.
  • Use warning when dealing with needles or different sharps, (e.g. by no means recap, bend, or reduce needles), and get rid of contaminated sharps in puncture-proof, labeled, closable sharps containers.
  • A logbook together with names, dates, and actions of all employees collaborating within the postmortem care and cleansing of the post-mortem suite must be stored and accessible for future observe up, if mandatory. The names of custodial workers coming into after hours or in the course of the day, also needs to be included within the logbook.
  • Cleansing and disinfection procedures of the post-mortem room, surfaces, and tools have to be carried out as described in Cleansing and Waste Disposal Advice part of this doc beneath.

Engineering Management Suggestions and Facility Design for Autopsies

Autopsies on decedents with confirmed or suspected COVID-19 optimally ought to  be carried out in Airborne An infection Isolation Rooms (AIIRs). If not accessible, different post-mortem suites with satisfactory air-handling techniques could also be used. These rooms should:

  • Keep destructive strain relative to surrounding areas with no air recirculation to adjoining areas.
  • Present a minimal of 6 air adjustments per hour (ACH) for current constructions and 12 ACH for renovated or new constructions.
  • Have air exhausted on to unoccupied areas outdoors the constructing.
  • Have native airflow management in place (i.e., laminar movement techniques) directing air from across the post-mortem desk downwards and away from personnel.
  • Have a Licensed Class II Biosafety Cupboard

Work surfaces ought to have integral waste containment and drainage options that decrease spills of physique fluids and wastewater.

As well as, doorways to the room must be stored closed besides throughout entry and egress. Entry and egress must be restricted to stop interruptions in airflow.  A transportable high-efficiency particulate air (HEPA) recirculation unit is also positioned within the room to supply additional air filtration. If use of an AIIR or HEPA unit shouldn’t be doable, the process must be carried out in probably the most protecting setting doable. AIIR room air ought to by no means be recirculated within the constructing, however instantly exhausted outside, away from home windows, doorways, areas of human visitors or gathering areas, and from different constructing air consumption techniques.

PPE Suggestions for Autopsies

The next mixture of PPE is beneficial for post-mortem procedures:

  • Surgical scrub go well with worn beneath impermeable robe or apron with full sleeve protection
  • Double surgical gloves interposed with a layer of cut-proof artificial mesh gloves
  • At a minimal, a NIOSH-approved disposable N95 respirator must be worn; nonetheless, as a result of probability of era of contagious aerosols throughout varied post-mortem procedures, powered air-purifying respirators (PAPRs) geared up with N95 or HEPA filters are beneficial.
    • PAPRs must be thought-about for personnel who can’t put on N95 respirators due to facial hair or different match limitations.
    • PAPRs with excessive effectivity filters might present elevated consolation throughout prolonged post-mortem procedures.
    • When respirators are mandatory to guard employees, employers should implement a complete respiratory safety program in accordance with the OSHA Respiratory Safety normal (29 CFR 1910.134exterior icon) that features medical exams, coaching, and match testing
  • Eye safety comparable to goggles or face protect that covers the entrance and sides of the face
    • Correct eye safety have to be chosen to make sure that the N95 respirator doesn’t intervene with the proper positioning of the attention safety, and the attention safety doesn’t have an effect on the match or seal of the respirator.
    • Protecting eyewear (e.g., security glasses and the face protect) with out gaps between glasses and the face to guard eyes from splashes and sprays.
  • Surgical caps
  • Shoe covers with non-slip tread

OSHA’s Respiratory Safety Security and Well being Subjects web page supplies extra details about respiratory safety packages, together with coachingexterior icon, match testingexterior icon, and compliancepdf icon assets

PPE must be worn following required don, use, and doff protocols to keep away from self-contamination and to mitigate threat of carrying the virus outdoors the post-mortem suite or adjoining anteroom.

After eradicating PPE, discard the PPE within the applicable laundry or waste receptacle. Reusable PPE (e.g., goggles, face shields, and PAPRs) have to be cleaned and disinfected in line with the producer’s suggestions earlier than reuse. Instantly after doffing PPE, wash palms with cleaning soap and water for 20 seconds. If cleaning soap and water aren’t accessible, an alcohol-based hand sanitizer that accommodates 60-95% alcohol could also be used. Nevertheless, if palms are visibly soiled, at all times wash palms with cleaning soap and water earlier than utilizing alcohol-based hand sanitizer. Always keep away from touching the face with palms Be sure that hand hygiene services are available on the level of use (e.g., at or adjoining to the PPE doffing space).

Personnel ought to observe contingency and disaster methods throughout PPE shortages. Seek advice from Methods for Optimizing the Provide of PPE together with:

As soon as PPE provides and availability return to regular, post-mortem services ought to promptly resume standard practices.

Further security and well being steerage is offered for employees dealing with deceased individuals with confirmed or suspected COVID-19 at https://www.cdc.gov/coronavirus/2019-ncov/hcp/using-ppe.html and the Occupational Security and Well being Administration (OSHA), COVID-19 web siteexterior icon

Assortment of Postmortem Specimens

Implementing correct biosafety and an infection management practices is vital when amassing specimens. Please discuss with Interim Laboratory Biosafety Tips for Dealing with and Processing Specimens Related to Coronavirus Illness 2019 (COVID-19) for extra info.

Assortment of Postmortem Swab Specimens for SARS-CoV-2 Testing

For suspected COVID-19 instances, CDC recommends amassing and testing postmortem NP swabs and if an post-mortem is carried out, decrease respiratory specimens (lung swabs). If the prognosis of COVID-19 was established earlier than loss of life, assortment of those specimens for COVID-19 testing is probably not mandatory. Health workers, coroners, and pathologists ought to work with public well being or medical laboratories to find out capability for testing postmortem swab specimens.

SARS-CoV-2 RT-PCR testing carried out on NP swab specimens is the popular selection for higher respiratory tract swab-based SARS-CoV-2 testing. When assortment of a postmortem NP swab shouldn’t be doable, assortment of every of the next for RT-PCR is a suitable various:

  • Oropharyngeal (OP) specimen
  • Nasal mid-turbinate (NMT) swab
  • Anterior nares (nasal swab; NS) specimen
  • Nasopharyngeal wash/aspirate or nasal aspirate (NA) specimen

Use solely artificial fiber swabs with plastic shafts. Comply with producer’s directions as some require using a selected swab for his or her take a look at. Don’t use calcium alginate swabs or swabs with wood shafts, as they might comprise substances that inactivate some viruses and inhibit RT-PCR testing. Place swabs instantly into sterile tubes containing 2-3 ml of viral transport media.

Nasal swabs (NS) or nasal mid-turbinate (NMT) swabs must be positioned in a transport tube containing both viral transport medium, Amies transport medium, or sterile saline.

If each NP and OP swabs are collected, they need to be mixed in a single tube to maximise take a look at sensitivity and restrict use of testing assets.

Higher Respiratory Tract Specimen Assortment: Nasopharyngeal Swab (NP swab)

  • Insert versatile wire shaft minitip swab by means of the nares parallel to the palate (not upwards) till resistance is encountered or the gap is equal to that from the ear to the nostril of the affected person, indicating contact with the nasopharynx. Swab ought to attain depth equal to distance from nostrils to outer opening of the ear. Gently rub and roll the swab. Depart swab in place for a number of seconds to soak up secretions. Slowly take away swab whereas rotating it.
  • For nasal swabs (NS), a single polyester swab with a plastic shaft must be used to pattern each anterior nares.
  • For extra steerage, see Interim Tips for Amassing, Dealing with, and Testing Scientific Specimens for COVID-19

Decrease respiratory tract Specimen Assortment: Lung swabs

  • Accumulate one swab from every lung (left and proper). Choices for lung swab assortment embody the next; nonetheless, the strategy of assortment might depend upon the establishment’s normal practices or sort of post-mortem process (e.g., full or in-situ post-mortem).
    • In the course of the inside examination, after the heart-lung block is eliminated, insert one swab as far down into the tracheobronchial tree as doable on both facet (left and proper).
    • First wipe the floor of every lung with an iodine-containing disinfectant clear and dry the floor; then use a sterile scalpel to chop a slit of the lung and insert the swab to gather pattern on both facet.

No information are at present accessible on the frequency of detection of SARS-CoV-2 by RT-PCR on postmortem swabs collected at completely different intervals after loss of life. If SARS-CoV-2 testing on postmortem swab specimens is being thought-about for a suspected COVID-19 case, SARS-CoV-2 RNA should still be detected as much as 3 days postmortem and probably longer, primarily based on accessible information from experiences with MERS-CoV and SARS-CoV; nonetheless, sensitivity could also be diminished with an extended postmortem interval or embalming. Length of sickness previous to loss of life might should be thought-about in deciphering a destructive consequence.

Issues Concerning Postmortem Speedy Antigen Testing

No information are at present accessible on detection of SARS-CoV-2 by antigen testing on postmortem swabs. Presently, the fast antigen checks which have acquired Emergency Use Authorizations (EUAs) from FDAexterior icon are approved for diagnostic testing on symptomatic individuals throughout the first 5 to 12 days of symptom onset. The sensitivity of fast antigen checks is mostly decrease than RT-PCR. CDC recommends confirming destructive antigen take a look at outcomes with an RT-PCR take a look at when the pretest chance is comparatively excessive. Please discuss with Interim Steering for Speedy Antigen Testing for SARS-CoV-2 for extra info.

Storage of Postmortem Swab Specimens

Retailer specimens at 2-8°C for as much as 72 hours after assortment. If a delay in testing or delivery is predicted, retailer specimens at -70°C or beneath.

Assortment of Postmortem Specimens for Different Routine Testing

If multiplex assays for the simultaneous detection of SARS-CoV-2, influenza viruses and different respiratory pathogens aren’t accessible, separate postmortem specimens (e.g., NP or lung swabs) must be collected for routine testing of respiratory pathogens at both medical or public well being labs. Word that laboratories ought to NOT try viral isolation from specimens collected from confirmed or suspected COVID-19 instances until that is carried out in a BSL-3 laboratory.

Different postmortem specimen assortment and evaluations must be directed by the decedent’s medical and publicity historical past, scene investigation, and gross post-mortem findings, and will embody routine bacterial cultures, toxicology, and different research as indicated.

Issues Concerning Postmortem Serologic Testing

Serologic checks for SARS-CoV-2 search for the presence of antibodies. Normally, a optimistic antibody take a look at is presumed to imply an individual was contaminated with SARS-CoV-2, the virus that causes COVID-19, sooner or later previously. It doesn’t imply they’re at present contaminated. It usually takes about one to a few weeks after  SARS-CoV-2 an infection for antibodies to develop; some folks might take longer. Relying on when somebody was contaminated and the timing of the take a look at, the take a look at might not discover antibodies in somebody with COVID-19 on the time of loss of life. Per FDA steerage, antibody checks haven’t been validated for prognosis of COVID-19, and antibody checks by themselves are of restricted worth within the rapid prognosis of a affected person the place COVID-19 is suspected. For extra info, see: Interim Tips for COVID-19 Antibody Testing.

Assortment of Post-mortem Tissue Specimens

Formalin-fixed moist tissues, and formalin-fixed, paraffin-embedded (FFPE) tissue specimens, obtained at post-mortem, can be utilized to determine a postmortem prognosis of COVID-19 by utilizing immunohistochemical and molecular methods accessible on the CDC’s Infectious Illnesses Pathology Department (IDPB). Submission of mounted post-mortem tissues to CDC’s IDPB for SARS-CoV-2 testing could also be indicated in some eventualities.  An essential benefit of this method is that it permits for the preservation and retention of comparatively steady specimens that may be examined at a later date to supply a confirmatory prognosis. The gathering of mounted tissues could be significantly essential when standard swab-based testing strategies aren’t accessible or have offered inconclusive outcomes.

Viral antigens and nucleic acids could also be focally distributed in respiratory tissues of sufferers with COVID-19 and the distribution and amount of virus can range amongst particular person sufferers. For these causes, we suggest amassing:

  1.  A minimal of three consultant sections of lung parenchyma, ideally from completely different places and any areas with lesions.

AND

  1.  A minimal of 1 part of airway, to incorporate trachea, bronchi, or each airways.

To reduce potential viral contamination of non-involved tissues, lung and airway specimens must be collected instantly following elimination of the chest plate. Then place specimens right into a separate sterile specimen cup containing 10% impartial buffered formalin.

Centered sampling of those tissues, collected by autopsies restricted to the chest, or by directed assortment achieved by incision, can be utilized when deemed applicable.

If involvement of a number of different organs is usually recommended by medical historical past or laboratory findings obtained previous to loss of life, assortment of consultant samples of those tissues must be thought-about. Full autopsies could possibly be warranted in sure circumstances, as decided by the medical expert, coroner, or group pathologist. As a result of COVID-19 can clinically and pathologically resemble different infectious illness processes that contain organ techniques along with the respiratory tract, consultant sections of main organs (i.e., coronary heart, liver, spleen, kidney, and mind) may help with an alternate prognosis if checks for SARS-CoV-2 are unrevealing. Assortment of tissues from different main organs may also facilitate the analysis of doable extrapulmonary problems of COVID-19.

Assortment of tissue samples roughly 5 mm in thickness (i.e., pattern would slot in a tissue cassette) is beneficial for optimum fixation. Tissues must be positioned in 10% buffered formalin, in a quantity that’s roughly 10 occasions better than the amount of tissue. Optimum fixation is three days (72 hours). Specimens must be shipped to CDC as quickly as doable following full fixation. Extended immersion in formalin, significantly if for longer than 4 weeks can diminish the sensitivity of virus detection assays.

Alternately, formalin-fixed, paraffin-embedded tissues (unique blocks obtained at post-mortem) could be submitted for analysis.

Dealing with Specimens Collected at Post-mortem

Personnel dealing with collected specimens and getting ready them to be taken out of the post-mortem suite ought to observe Commonplace Precautions. Specimens have to be correctly secured in line with diagnostic laboratory suggestions and positioned in an appropriately labeled leakproof major container.

  • Inside the post-mortem suite, major containers must be positioned right into a leakproof secondary container.
  • If doable, the secondary container ought to then be positioned right into a resealable plastic bag that was not within the post-mortem suite when the specimens have been collected.
  • The first and secondary containers and resealable plastic bag must be wiped down with applicable Environmental Safety Company (EPA)-approved disinfectantsexterior icon earlier than every subsequent step.
  • The resealable plastic bag ought to then be positioned right into a labeled organic specimen bag with absorbent materials; after which could be transferred outdoors of the post-mortem suite.

Staff receiving the organic specimen bag outdoors the post-mortem suite or anteroom ought to ship the specimen in a protected method to a laboratory workers who can proceed with ultimate packing and delivery procedures.

Extra details about preparation of specimens for cargo could also be discovered at Interim Laboratory Biosafety Tips for Dealing with and Processing Specimens Related to Coronavirus Illness 2019 (COVID-19).

Submission of Specimens for SARS-CoV-2 Testing

Health workers, coroners, and different healthcare professionals ought to work with their state, tribal, nativeexterior icon, and territorial well being departments to coordinate testing by means of public well being laboratories. As well as, SARS-CoV-2 testing, approved by the Meals and Drug Administration beneath an Emergency Use Authorization (EUA)exterior icon, is offered in medical laboratories.

Submission of Postmortem Swab Specimens to CDC

Postmortem swab specimens could also be shipped to CDC for SARS-CoV-2 RT-PCR testing if testing shouldn’t be accessible at public well being or medical laboratories in a jurisdiction, or if repeated testing outcomes stay inconclusive, or if different uncommon outcomes are obtained. State or native well being departments ought to contact CDC at respvirus@cdc.gov previous to submitting samples to obtain approval.

If specimens will ship immediately, retailer specimens at 2-8°C, and ship in a single day to CDC on ice pack. If a delay in delivery will lead to receipt at CDC greater than 72 hours after assortment, retailer specimens at -70°C or beneath and ship in a single day to CDC on dry ice. Further helpful and detailed info on packing, delivery, and transporting specimens could be discovered at Interim Laboratory Biosafety Tips for Dealing with and Processing Specimens Related to Coronavirus Illness 2019 (COVID-19). Specimens have to be packaged, shipped, and transported in line with the present version of the Worldwide Air Transport Affiliation (IATA) Harmful Items Lawsexterior icon.

Label every specimen container with the affected person’s ID quantity (e.g., medical report quantity), distinctive CDC or state-generated specimen ID (e.g., laboratory requisition quantity), specimen sort (e.g., NP swab) and the date the pattern was collected. Full a CDC Type 50.34 for every specimen submitted. Within the higher left field of the shape, 1) for take a look at requested choose “Respiratory virus molecular detection (non-influenza) CDC-10401” and a couple of) for At CDC, convey to the eye of enter “Unit 84 (Non-flu Resp Virus)-Post-mortem”.

Please discuss with directions for submitting CDC Type 50.34 discovered right here: Tips For Submitting Specimens to CDC. pdf icon

For extra info, session, or the CDC delivery tackle, contact the CDC Emergency Operations Heart (EOC) at 770-488-7100.

Submission of Mounted Post-mortem Tissue Specimens to CDC

Standards for Mounted Post-mortem Tissue Specimen Submission

Right now, CDC’s Infectious Illnesses Pathology Department is accepting tissues mounted in 10% impartial buffered formalin, in addition to formalin-fixed, paraffin-embedded (FFPE) tissue blocks obtained at post-mortem for SARS-CoV-2 testing from decedents when the following three standards are met:

  1. Scientific or pathologic findings, and epidemiologic historical past point out want for COVID-19 testing (i.e., meets standards A OR B beneath):
    1. Demise occurring on or after 12/1/2019 with medical or pathologic findings and epidemiologic historical past in keeping with doable COVID-19, however no laboratory proof of SARS-CoV-2 (i.e., meets the entire following 4 standards):
      1. Demise occurring on or after 12/1/2019,

      AND

      1. Scientific or pathologic findings suggestive of COVID-19 (i.e., meets standards a OR b beneath):
        1. Historical past of fever or a number of different indicators or signs regarding for COVID-19 (e.g., cough, shortness of breath)

        OR

        1. Histopathologic findings in respiratory tissues in keeping with a doable infectious course of, together with diffuse alveolar harm, pulmonary hemorrhage, interstitial pneumonitis, capillaritis, intravascular leukocytosis, fibrin thrombi, bronchopneumonia, tracheitis, or bronchitis

      AND

      1. SARS-CoV-2 testing on respiratory swab specimens has not been carried out, or is destructive, inconclusive, or invalid

      AND

      1. No absolutely explanatory various etiology
        1. Decedents might have infectious illness testing optimistic for a number of different pathogens, however evaluate of medical, pathologic, and epidemiologic info means that COVID-19 also needs to be thought-about.

    OR

    1. Demise with laboratory proof of SARS-CoV-2 by antemortem or postmortem testing however with questions concerning the connection of outcomes to reported medical historical past, noticed gross or histopathologic findings at post-mortem, or the reason for loss of life

AND

  1. Enough specimens can be found:
    1. Formalin-fixed (moist) tissues or formalin-fixed, paraffin-embedded (FFPE) tissue blocks from lung and higher airway:
      • If > 4 weeks have elapsed for the reason that post-mortem, unique FFPE tissue blocks from the time of post-mortem can be found. for submission.
      • If FFPE tissue blocks are submitted, a minimal of two respiratory tissue blocks is required. Nevertheless, as a result of viral antigens and nucleic acids could be distributed focally, possibilities of detection are enhanced significantly when a minimal of three blocks of lung and 1 block of enormous airway (trachea or mainstem bronchus) are submitted for analysis.
    2. Submission of mounted tissues from different main organs, together with coronary heart, kidney, liver, spleen, and mind shouldn’t be required, however is very beneficial to raised consider extrapulmonary problems of COVID-19 and to optimize evaluation for coinfections or various infectious etiologies.

AND

  1. Approval of applicable state or native well being division for specimen submission to CDC has been obtained.

Mounted Post-mortem Tissue Specimen Pre-Approval and Submission Directions

For instances assembly the above standards, observe the steps outlined beneath to acquire pre-approval from CDC’s Infectious Illnesses Pathology Department to submit specimens for analysis:

  1. Reminder–Healthcare suppliers, pathologists, health workers, and coroners—please first contact your state, tribal, native, or territorial well being division for approval for specimen submission to CDC.
  2. Contact CDC’s Infectious Illnesses Pathology Department at pathology@cdc.gov for pre-approval. Embrace the next info within the e mail:
    1. Temporary medical historical past
    2. Description of gross or histopathologic findings within the tissues to be submitted
    3. Itemizing of accessible formalin-fixed tissues

In your e mail correspondence, don’t embody affected person identifiers comparable to title, date of beginning, or medical report quantity. You need to observe all relevant federal, state, tribal, native, and territorial rules to stick to affected person confidentiality and privateness protections.

  1. After you obtain e mail approval from CDC:
    1. Electronically fill, save, and print each pages of the CDC Type 50.34.
      1. A prepopulated CDC Type 50.34  must be offered to pathology@cdc.gov with the preapproval to submit, together with state-specific public well being laboratory contact info and the next fields.  Don’t change or delete this info:
        1. Check Order Identify: “Pathologic Analysis of Tissues for Attainable Infectious Etiologies”.
        2. Check Order Code: “CDC-10365”.
        3. Suspected Agent: “Extreme Acute Respiratory Syndrome coronavirus 2 (SARS-CoV-2)”
        4. At CDC, convey to the eye of: “Dr. Sherif Zaki (IDPB/Unit 109)”
      2. Please present any relevant CDC and State NCOV Case ID numbers within the Feedback part on Web page 2 of the CDC 50.34 kind.
    2. Along with the CDC Type 50.34, enclose the next within the specimen submission bundle:
      1. Post-mortem report (preliminary is suitable) or block log
      2. Related medical notes, together with admission Historical past and Bodily (H&P), discharge abstract, if relevant
  2. Mailing/Contact Information:
    1. Formalin-fixed moist tissues and/or formalin-fixed, paraffin-embedded tissue blocks must be shipped in appropriate packaging at ambient temperature. Don’t freeze mounted tissues.
    2. Ship to: Dr. Sherif Zaki, CDC, IDPB, 1600 Clifton Rd NE, MS: H18-SB, Atlanta, GA 30329-4027
    3. Ship monitoring quantity to pathology@cdc.gov
    4. Tel: 404-639-3132, Fax: 404-638-5358, E mail: pathology@cdc.gov

Cleansing and Waste Disposal Suggestions

CDC steerage states that the administration of regulated medical waste must be carried out in accordance with routine procedures because it has not been implicated within the transmission of SARS-CoV-2, the virus that causes COVID-19. Nevertheless, post-mortem services ought to have a plan compliant with the medical waste administration coverage describing the procedures of transporting waste out of the post-mortem room into a chosen accumulation space. Waste ought to then handled by an incineration methodology onsite or transported in USDOT-approved containers offsite for therapy.

Regulated Medical Waste and Class B infectious substances are listed within the USDOT Hazardous Supplies Laws (HMR) 49 Code of Federal Laws 173.197exterior icon. A particular allow issued by the USDOT is not required to move RMW contaminated with SARS-CoV-2.

The next are common tips for cleansing and waste disposal following an post-mortem of a decedent with confirmed or suspected COVID-19. Present proof means that SARS-CoV-2 might stay viable for hours to days on surfaces produced from a wide range of supplies.

Use Environmental Safety Company (EPA)-approved disinfectantsexterior icon that meet the standards to be used to inactivate SARS-CoV-2, the virus that causes COVID-19. Present information counsel that survival time of SARS-CoV-2 on surfaces varies and is determined by the kind of floor materials. Decide probably the most applicable disinfectant for the floor or object, particularly to be used on arduous, non-porous surfaces and for the precise utility want. Comply with the producer’s directions for all cleansing and disinfection merchandise (e.g., focus, utility methodology, contact time).

  • Apply the disinfectant as instructed on the disinfectant producer’s label. Guarantee satisfactory contact time for efficient disinfection.
  • Adhere to any security precautions or different label suggestions as directed (e.g., permitting satisfactory air flow in confined areas and correct disposal of unused product or used containers).
  • Keep away from utilizing product utility strategies that trigger splashing or generate aerosols.

After an post-mortem of a decedent with confirmed or suspected COVID-19, the next suggestions apply for cleansing of the post-mortem room (and anteroom if relevant):

  • Ensure that air flow techniques are energetic and working correctly, as described in part Engineering Management Suggestions for Autopsies
  • Put on applicable PPE:
    • Put on disposable gloves beneficial by the producer of the cleaner and disinfectant getting used.
      • Get rid of gloves in the event that they grow to be broken or dirty and when cleansing is accomplished, as described beneath. By no means wash or reuse gloves.
    • Use eye safety.
    • Put on a clear, long-sleeved fluid-resistant robe to guard pores and skin and clothes.
  • Put on a NIOSH-approved disposable N95 or greater respirator.
    • If NIOSH-approved N95 or higher-level respirators are used, a complete respiratory safety program in accordance with the OSHA Respiratory Safety normal (29 CFR 1910.134exterior icon) that features medical exams, match testing, and coaching have to be applied.
    • Guarantee employees are skilled on OSHA’s Hazard Communication normal, 29 CFR 1910.1200exterior icon, to speak with employees in regards to the hazardous chemical substances used within the office.
    • Further PPE could also be required to guard personnel from potential hazards related to merchandise that may have been utilized in post-mortem procedures. Use the extra PPE in accordance with the label directions of the precise product. See CDC Tips for Secure Work Practices in Human and Animal Diagnostic Laboratoriespdf icon for extra info.
    • If PPE is in low provide, contemplate having personnel who carried out autopsies conduct the cleansing and sanitizing of the realm.
    • Personnel ought to observe contingency and disaster methods throughout PPE shortages. Seek advice from Methods for Optimizing the Provide of PPE.
  • Gross contamination and liquids must be collected with absorbent supplies, comparable to towels, by workers conducting the post-mortem carrying designated PPE. Gross contamination and liquids ought to then be disposed of as described beneath:
    • Use of tongs and different utensils can decrease the necessity for private contact with dirty absorbent supplies.
    • Massive areas contaminated with physique fluids must be handled with disinfectant following elimination of the fluid with absorbent materials. The realm ought to then be cleaned and given a ultimate disinfection.
    • Small quantities of liquid waste (e.g., physique fluids) could be flushed or washed down bizarre sanitary drains with out particular procedures. Waste from sanitary drains is directed to a water therapy plant the place it’s successfully handled. State rules might dictate the utmost quantity allowable for discharge of physique fluids to the sanitary sewer.
  • Don’t use compressed air and/or water beneath strain for cleansing, or some other strategies that may trigger splashing or may kind aerosolized infectious materials.
  • Comply with site-specific normal working procedures for the containment and disposal of used PPE and controlled medical waste.
  • Get rid of human tissues in line with routine procedures for pathological waste.
  • Sharps containers must be incinerated in a medical waste incinerator.
  • Clear and disinfect or autoclave non-disposable devices, taking applicable precautions with sharp objects.
  • Supplies or clothes that might be laundered could be faraway from the post-mortem suite (or anteroom, if relevant) in a sturdy, leak-proof biohazard bag that’s tied shut and never reopened. These supplies ought to then be despatched for laundering in line with routine procedures. utilized in healthcare settings.
  • Preserve digital camera, telephones, pc keyboards, and different gadgets that stay within the post-mortem suite (or anteroom, if relevant) as clear as doable, however deal with as if they’re contaminated and deal with with gloves. Wipe the gadgets after use with applicable Environmental Safety Company (EPA)-approved disinfectantsexterior icon that meet the standards to be used in opposition to SARS-CoV-2, the virus that causes COVID-19. If being faraway from the post-mortem suite, guarantee decontamination to the extent doable with applicable disinfectant in line with the producer’s suggestions previous to elimination and reuse.
  • When cleansing is full and PPE has been eliminated, wash palms instantly following CDC Hand Hygiene Suggestions.  Keep away from touching the face with gloved or unwashed palms.

Cleansing actions must be supervised and inspected periodically to make sure appropriate procedures are adopted.

Dealing with and Transportation of Human Stays

The danger of transmission of SARS-CoV-2 virus from human stays outdoors of the post-mortem setting is low; nonetheless, use normal precautions, together with extra PPE if splashing of fluids is predicted when dealing with and transporting human stays.

Mixture of PPE that must be used:

  • Lengthy-sleeved fluid-resistant or impermeable robe
  • Plastic face protect or a surgical masks and goggles
  • Nonsterile, nitrile gloves
  • Heavy obligation gloves over nitrile gloves if there’s a threat for cuts, puncture, and penetration of the pores and skin
  • NIOSH-approved N95 respirator or greater if there’s a threat of aerosols era whereas dealing with human stays

Commonplace physique bagging procedures must be adopted, in keeping with procedures used for deaths when there isn’t any confirmed or suspected COVID-19. Given the various weights of decedents and selection, building, and situations of physique bag supplies, postmortem care employees ought to use prudent judgement figuring out if dangers for puncture, tearing, or failure of physique baggage may happen and whether or not a second physique bag or a physique bag of thicker, stronger materials (e.g. minimal of 6 mil thickness) is important. Danger elements embody:

  • Presence of sharp objects on the decedent that might trigger punctures or tears (e.g. jewellery, piercings, medical devices)
  • Weight of the decedent that might trigger the bag or bag deal with to fail throughout transport (if accessible, confirm physique bag weight capacities as offered by the producer)
  • Bodily fluids posing publicity dangers to employees transporting the physique ought to a puncture, tear, or failure happen (e.g. SARS-CoV-2 has been detected within the feces of some sufferers identified with COVID-19, although whether or not the virus in stool is infectious is unknown). Commonplace Precautions for bloodborne pathogens ought to at all times be taken.
  • Harm or degradation to the physique bag which will have occurred in cargo or storage (e.g. the bag is damaged or brittle).

After the physique has been bagged, disinfect the skin of the bag with Environmental Safety Company (EPA)-approved disinfectantsexterior icon that meet the standards to be used in opposition to SARS-CoV-2, the virus that causes COVID-19, utilized in line with the producer’s suggestions.



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