Collection and Submission of Postmortem Specimens from Deceased Persons with Confirmed or Suspected COVID-19

Summary of Recent Changes

Background

Medical examiners, coroners, and pathologists should immediately notify their localexternal icon or state pdf icon[31.6 KB, 2 Pages]external icon health department in the event of the identification of a deceased person with confirmed or suspected COVID-19.

This document provides specific interim recommendations for the collection and submission of postmortem specimens from deceased persons with confirmed or suspected COVID-19 .  This interim guidance is based on what is currently known about coronavirus disease 2019 (COVID-19), including what is known regarding how SARS-CoV-2 spreads.

This document also provides recommendations for biosafety and infection control practices during specimen collection and handling, including during autopsy procedures. The guidance can be used by medical examiners, coroners, pathologists, other workers involved in providing postmortem care, and state, tribal, local, and territorial health departments. In the healthcare setting, the term “aerosol” is used with respect to aerosol-generating procedures (AGP) that produce small droplets and particles and require distinct engineering controls to prevent occupational transmission of infectious pathogens like SARS-CoV-2. Postmortem activities should be conducted with a focus on avoiding AGPs and, if aerosol generation is likely (e.g., when using an oscillating saw), ensuring that appropriate engineering controls and personal protective equipment (PPE) are used. These precautions and the use of Standard Precautions are  appropriate work practices to help prevent direct contact with infectious material, percutaneous injury, and other hazards related to moving human remains and handling embalming chemicals.

Medical examiners, coroners, and other healthcare professionals should use professional judgment to determine if a decedent had signs and symptoms compatible with COVID-19 during life and whether postmortem testing is necessary. Many patients with confirmed COVID-19 have developed fever and/or symptoms of acute respiratory illness (e.g., fever, cough, difficulty breathing). There are epidemiologic factors that may also help guide decisions about testing for SARS-CoV-2, such as documented COVID-19 in a jurisdiction, known community transmission, contact with a known COVID-19 patient, or being a part of a cluster of respiratory illness in a closed setting (e.g., a long-term care facility). Testing for other causes of respiratory illness (e.g., influenza) is strongly encouraged, see Information for Clinicians on Influenza Virus Testing.

Recommended Postmortem Specimens and Testing

Recommendations about the type of postmortem specimens to collect vary based on whether the case of COVID-19 is suspected or confirmed, as well as whether an autopsy is performed. The following factors should be considered when determining if an autopsy will be performed for a deceased person with confirmed or suspected COVID-19:

The following factors should be considered when determining if an autopsy will be performed for a deceased person with confirmed or suspected COVID-19:

• Medicolegal jurisdiction
• Facility environmental controls
• Availability of recommended PPE
• Family and cultural wishes

If an autopsy is performed for a suspected COVID-19 case, collection of the following postmortem specimens and performance of the following testing are recommended:

• Postmortem swab specimens for SARS-CoV-2 testing:
  • Specimens:
    • Upper respiratory tract swab: Nasopharyngeal Swab (NP swab)
    • Lower respiratory tract swab: Lung swab from each lung
  • Testing:
    • Reverse transcription-polymerase chain reaction (RT-PCR) remains the “gold standard” for clinical diagnostic detection of SARS-CoV-2.
• Postmortem swab specimens for testing of influenza viruses and other respiratory pathogens. For more information on influenza testing methods, please refer to Information for Clinicians on Influenza Virus Testing.
  • Collection of separate swabs will be needed if multiplex assays for the simultaneous detection of SARS-CoV-2, influenza viruses, and other respiratory pathogens are not available. Work with public health or clinical laboratories to determine what type of testing is available.
• Other postmortem microbiologic and infectious disease testing, as indicated.
• Formalin-fixed autopsy tissues from lung, upper airway and other major organs (e.g., heart, liver, kidney). Submission of fixed autopsy tissues to CDC for SARS-CoV-2 testing may be indicated in some scenarios.

If an autopsy is NOT performed for a suspected COVID-19 case, collection of the following postmortem specimens and performance of the following testing are recommended:

• Postmortem NP swab specimen for SARS-CoV-2 testing
  • RT-PCR remains the “gold standard” for clinical diagnostic detection of SARS-CoV-2.
• Postmortem swab specimens for testing for influenza viruses and other respiratory pathogens. For more information on influenza testing methods, please refer to Information for Clinicians on Influenza Virus Testing.
  • Collection of separate swabs will be needed if multiplex assays for the simultaneous detection of SARS-CoV-2, influenza viruses, and other respiratory pathogens are not available.

If an autopsy is performed for a confirmed COVID-19 case, collection of the following postmortem specimens should be considered:

• Postmortem swab specimens for testing for influenza viruses and other respiratory pathogens. For more information on influenza testing methods, please refer to Information for Clinicians on Influenza Virus Testing.
• Other postmortem microbiologic and infectious disease testing, as indicated.
• Formalin-fixed autopsy tissues from lung, upper airway and other major organs (e.g., heart, liver, kidney). Submission of fixed autopsy tissues to CDC for SARS-CoV-2 testing may be indicated in some scenarios.

In addition to postmortem specimens, any remaining specimens (e.g., NP swab, sputum, bronchoalveolar lavage) that may have been collected prior to death should be retained. Please refer to Interim Guidelines for Collecting, Handling, and Testing Clinical Specimens for COVID-19 for more information.

Recommended Biosafety and Infection Control Practices

Biosafety is critical for personnel who are in contact with human remains with confirmed or suspected COVID-19, or other infectious diseases. A site-specific risk assessment should be completed before conducting any procedures. Protective measures must be based on personnel’s function-specific responsibilities.

OSHA recommends strict adherence to basic safety procedures used for any autopsy on human remains. Please see OSHA’s Interim Guidance for Workers and Employers at Increased Risk of Occupational Exposureexternal icon.

Collection of Postmortem Nasopharyngeal Swab (NP Swab) Specimens Only

Instructions in this section apply if only postmortem NP swabs are being collected from a deceased person with confirmed or suspected COVID-19.

If a postmortem NP swab is being collected, only those personnel who are obtaining the specimen should be in the room. Personnel should follow Standard Precautions. In addition to Standard Precautions, the following are recommended:

Engineering Control Recommendations for NP Swab Collection

Because collection of NP swab specimens from deceased persons will not induce coughing or sneezing, a negative pressure room is not required. Personnel should always adhere to Standard Precautions as described previously.

PPE Recommendations for NP Swab Collection

If only a NP swab is being collected, a N95 respirator or higher-level respirator is not required because collection of NP swab specimens from deceased persons will not induce coughing or sneezing.

At a minimum, the following PPE should be worn:

• Nonsterile, nitrile, latex, or rubber gloves when handling potentially infectious materials.
• Heavy-duty gloves worn over the nitrile gloves if there is a risk of cuts, puncture wounds, or other injuries that may break the skin.
• Long-sleeved fluid-resistant or impermeable hospital isolation gown to protect skin and clothing.
• Plastic face shield; or a face mask and goggles to protect the face, eyes, nose, and mouth from splashes of potentially infectious bodily fluids.

For more information on PPE, visit Using Personal Protective Equipment (PPE), Personal Protective Equipment: Questions and Answers, and Respirator Fit Testing pdf icon[525 KB, 2 Pages].

Autopsy Precautions and Procedures

Personnel who have contact with human remains, including those performing autopsy and collecting or handling specimens, are at risk for exposure to infectious agents, such as SARS-CoV-2, that may be present in tissues, blood, and other bodily fluids of the deceased person. Additionally, personnel might be exposed to residual surface contamination. Autopsy should be undertaken by using appropriate biosafety measures and procedures. All autopsy facilities should have written biosafety policies, site-specific risk assessments, and procedures, and all participating personnel should receive prior training in policies and procedures.

To prevent or limit exposures, Standard Precautions, Contact Precautions, and Airborne Precautions with eye protection (goggles or a face shield) should be followed during autopsy. Many of the following procedures are consistent with existing guidelines for safe work practices in the autopsy setting; see Guidelines for Safe Work Practices in Human and Animal Medical Diagnostic Laboratories:

• Autopsy room must have a precautionary sign posted on the entry door (e.g., “Autopsy in Progress”, “Authorized Personnel Only”, “SARS-CoV-2 Awareness”, “Proper PPE Required”).
• Personnel must wear appropriate PPE.

• Number of personnel working in the autopsy suite and on the human body should be limited to the minimum number of people necessary to safely conduct the autopsy.
• Use a biosafety cabinet Class II or higher for the handling and examination of specimens and other containment equipment whenever possible.

• AGPs such as use of an oscillating bone saw should be avoided for confirmed or suspected COVID-19 cases. Consider using hand shears as an alternative cutting tool. If an oscillating saw is used, attach a vacuum shroud to contain aerosols.

• Use caution when handling needles or other sharps, (e.g. never recap, bend, or cut needles), and dispose of contaminated sharps in puncture-proof, labeled, closable sharps containers.
• A logbook including names, dates, and activities of all workers participating in the postmortem care and cleaning of the autopsy suite should be kept and available for future follow up, if necessary. The names of custodial staff entering after hours or during the day, should also be included in the logbook.
• Cleaning and disinfection procedures of the autopsy room, surfaces, and equipment must be performed as described in Cleaning and Waste Disposal Recommendation section of this document below.

Engineering Control Recommendations and Facility Design for Autopsies

Autopsies on decedents with confirmed or suspected COVID-19 optimally should  be conducted in Airborne Infection Isolation Rooms (AIIRs). If not available, other autopsy suites with adequate air-handling systems may be used. These rooms must:

• Maintain negative pressure relative to surrounding areas with no air recirculation to adjacent spaces.
• Provide a minimum of 6 air changes per hour (ACH) for existing structures and 12 ACH for renovated or new structures.
• Have air exhausted directly to unoccupied areas outside the building.
• Have local airflow control in place (i.e., laminar flow systems) directing air from around the autopsy table downwards and away from personnel.
• Have a Certified Class II Biosafety Cabinet

Work surfaces should have integral waste containment and drainage features that minimize spills of body fluids and wastewater.

In addition, doors to the room should be kept closed except during entry and egress. Entry and egress should be limited to prevent interruptions in airflow.  A portable high-efficiency particulate air (HEPA) recirculation unit could also be placed in the room to provide further air filtration. If use of an AIIR or HEPA unit is not possible, the procedure should be performed in the most protective environment possible. AIIR room air should never be recirculated in the building, but directly exhausted outdoors, away from windows, doors, areas of human traffic or gathering spaces, and from other building air intake systems.

PPE Recommendations for Autopsies

The following combination of PPE is recommended for autopsy procedures:

• Surgical scrub suit worn under impermeable gown or apron with full sleeve coverage
• Double surgical gloves interposed with a layer of cut-proof synthetic mesh gloves
• At a minimum, a NIOSH-approved disposable N95 respirator should be worn; however, due to the likelihood of generation of contagious aerosols during various autopsy procedures, powered air-purifying respirators (PAPRs) equipped with N95 or HEPA filters are recommended.
  • PAPRs should be considered for personnel who cannot wear N95 respirators because of facial hair or other fit limitations.
  • PAPRs with high efficiency filters may provide increased comfort during extended autopsy procedures.
  • When respirators are necessary to protect workers, employers must implement a comprehensive respiratory protection program in accordance with the OSHA Respiratory Protection standard (29 CFR 1910.134external icon) that includes medical exams, training, and fit testing
• Eye protection such as goggles or face shield that covers the front and sides of the face
  • Proper eye protection must be selected to ensure that the N95 respirator does not interfere with the correct positioning of the eye protection, and the eye protection does not affect the fit or seal of the respirator.
  • Protective eyewear (e.g., safety glasses and the face shield) without gaps between glasses and the face to protect eyes from splashes and sprays.
• Surgical caps
• Shoe covers with non-slip tread

OSHA’s Respiratory Protection Safety and Health Topics page provides additional information about respiratory protection programs, including trainingexternal icon, fit testingexternal icon, and compliance pdf icon[14.9 MB, 124 Pages]external icon resources

PPE should be worn following required don, use, and doff protocols to avoid self-contamination and to mitigate risk of carrying the virus outside the autopsy suite or adjacent anteroom.

After removing PPE, discard the PPE in the appropriate laundry or waste receptacle. Reusable PPE (e.g., goggles, face shields, and PAPRs) must be cleaned and disinfected according to the manufacturer’s recommendations before reuse. Immediately after doffing PPE, wash hands with soap and water for 20 seconds. If soap and water are not available, an alcohol-based hand sanitizer that contains 60-95% alcohol may be used. However, if hands are visibly dirty, always wash hands with soap and water before using alcohol-based hand sanitizer. At all times avoid touching the face with hands Ensure that hand hygiene facilities are readily available at the point of use (e.g., at or adjacent to the PPE doffing area).

Personnel should follow contingency and crisis strategies during PPE shortages. Refer to Strategies for Optimizing the Supply of PPE including:

• Implementing extended and limited reuse of N95 respirators (reserving N95 respirators for aerosol-generating procedures), considering using N95s beyond manufacturer-designated shelf life and considerations for use of elastomeric respirators during surge demand situations.
• On October 15, 2020 U.S. Food and Drug Administration (FDA) reissued the Emergency Use Authorizationexternal icon (EUA) for certain filtering face-piece respirators (FFRs) that are manufactured in China and are not approved by the CDC’s National Institute for Occupational Safety and Health (NIOSH).
• Implementing Strategies for optimizing the supply of isolation gowns including consideration of the use of coveralls and prioritizing the use of gowns.

Once PPE supplies and availability return to normal, autopsy facilities should promptly resume conventional practices.

Additional safety and health guidance is available for workers handling deceased persons with confirmed or suspected COVID-19 at https://www.cdc.gov/coronavirus/2019-ncov/hcp/using-ppe.html and the Occupational Safety and Health Administration (OSHA), COVID-19 websiteexternal icon

Collection of Postmortem Specimens

Implementing proper biosafety and infection control practices is critical when collecting specimens. Please refer to Interim Laboratory Biosafety Guidelines for Handling and Processing Specimens Associated with Coronavirus Disease 2019 (COVID-19) for additional information.

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

For suspected COVID-19 cases, CDC recommends collecting and testing postmortem NP swabs and if an autopsy is performed, lower respiratory specimens (lung swabs). If the diagnosis of COVID-19 was established before death, collection of these specimens for COVID-19 testing may not be necessary. Medical examiners, coroners, and pathologists should work with public health or clinical laboratories to determine capacity for testing postmortem swab specimens.

SARS-CoV-2 RT-PCR testing performed on NP swab specimens is the preferred choice for upper respiratory tract swab-based SARS-CoV-2 testing. When collection of a postmortem NP swab is not possible, collection of each of the following for RT-PCR is an acceptable alternative:

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

Use only synthetic fiber swabs with plastic shafts. Follow manufacturer’s instructions as some require the use of a particular swab for their test. Do not use calcium alginate swabs or swabs with wooden shafts, as they may contain substances that inactivate some viruses and inhibit RT-PCR testing. Place swabs immediately into sterile tubes containing 2-3 ml of viral transport media.

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

If both NP and OP swabs are collected, they should be combined in a single tube to maximize test sensitivity and limit use of testing resources.

Upper Respiratory Tract Specimen Collection: Nasopharyngeal Swab (NP swab)

• Insert flexible wire shaft minitip swab through the nares parallel to the palate (not upwards) until resistance is encountered or the distance is equivalent to that from the ear to the nostril of the patient, indicating contact with the nasopharynx. Swab should reach depth equal to distance from nostrils to outer opening of the ear. Gently rub and roll the swab. Leave swab in place for several seconds to absorb secretions. Slowly remove swab while rotating it.
• For nasal swabs (NS), a single polyester swab with a plastic shaft should be used to sample both anterior nares.
• For additional guidance, see Interim Guidelines for Collecting, Handling, and Testing Clinical Specimens for COVID-19

Lower respiratory tract Specimen Collection: Lung swabs

• Collect one swab from each lung (left and right). Options for lung swab collection include the following; however, the method of collection may depend on the institution’s standard practices or type of autopsy procedure (e.g., full or in-situ autopsy).
  • During the internal exam, after the heart-lung block is removed, insert one swab as far down into the tracheobronchial tree as possible on either side (left and right).
  • First wipe the surface of each lung with an iodine-containing disinfectant clean and dry the surface; then use a sterile scalpel to cut a slit of the lung and insert the swab to collect sample on either side.

No data are currently available on the frequency of detection of SARS-CoV-2 by RT-PCR on postmortem swabs collected at different intervals after death. If SARS-CoV-2 testing on postmortem swab specimens is being considered for a suspected COVID-19 case, SARS-CoV-2 RNA may still be detected up to 3 days postmortem and possibly longer, based on available data from experiences with MERS-CoV and SARS-CoV; however, sensitivity may be reduced with a longer postmortem interval or embalming. Duration of illness prior to death may need to be considered in interpreting a negative result.

Considerations Regarding Postmortem Rapid Antigen Testing

No data are currently available on detection of SARS-CoV-2 by antigen testing on postmortem swabs. Currently, the rapid antigen tests that have received Emergency Use Authorizations (EUAs) from FDAexternal icon are authorized for diagnostic testing on symptomatic persons within the first five to twelve days of symptom onset. The sensitivity of rapid antigen tests is generally lower than RT-PCR. CDC recommends confirming negative antigen test results with an RT-PCR test when the pretest probability is relatively high. Please refer to Interim Guidance for Rapid Antigen Testing for SARS-CoV-2 for more information.

Storage of Postmortem Swab Specimens

Store specimens at 2-8°C for up to 72 hours after collection. If a delay in testing or shipping is expected, store specimens at -70°C or below.

Collection of Postmortem Specimens for Other Routine Testing

If multiplex assays for the simultaneous detection of SARS-CoV-2, influenza viruses and other respiratory pathogens are not available, separate postmortem specimens (e.g., NP or lung swabs) should be collected for routine testing of respiratory pathogens at either clinical or public health labs. Note that laboratories should NOT attempt viral isolation from specimens collected from confirmed or suspected COVID-19 cases unless this is performed in a BSL-3 laboratory.

Other postmortem specimen collection and evaluations should be directed by the decedent’s clinical and exposure history, scene investigation, and gross autopsy findings, and may include routine bacterial cultures, toxicology, and other studies as indicated.

Considerations Regarding Postmortem Serologic Testing

Serologic tests for SARS-CoV-2 look for the presence of antibodies. In general, a positive antibody test is presumed to mean a person was infected with SARS-CoV-2, the virus that causes COVID-19, at some point in the past. It does not mean they are currently infected. It typically takes about one to three weeks after  SARS-CoV-2 infection for antibodies to develop; some people may take longer. Depending on when someone was infected and the timing of the test, the test may not find antibodies in someone with COVID-19 at the time of death. Per FDA guidance, antibody tests have not been validated for diagnosis of COVID-19, and antibody tests by themselves are of limited value in the immediate diagnosis of a patient where COVID-19 is suspected. For more information, see: Interim Guidelines for COVID-19 Antibody Testing.

Collection of Autopsy Tissue Specimens

Formalin-fixed wet tissues, and formalin-fixed, paraffin-embedded (FFPE) tissue specimens, obtained at autopsy, can be used to establish a postmortem diagnosis of COVID-19 by using immunohistochemical and molecular techniques available at the CDC’s Infectious Diseases Pathology Branch (IDPB). Submission of fixed autopsy tissues to CDC’s IDPB for SARS-CoV-2 testing may be indicated in some scenarios.  An important advantage of this approach is that it allows for the preservation and retention of relatively stable specimens that can be tested at a later date to provide a confirmatory diagnosis. The collection of fixed tissues can be particularly important when conventional swab-based testing methods are not available or have provided inconclusive results.

Viral antigens and nucleic acids may be focally distributed in respiratory tissues of patients with COVID-19 and the distribution and quantity of virus can vary among individual patients. For these reasons, we recommend collecting:

1.  A minimum of 3 representative sections of lung parenchyma, preferably from different locations and any areas with lesions.

AND

2.  A minimum of 1 section of airway, to include trachea, bronchi, or both airways.

To minimize potential viral contamination of non-involved tissues, lung and airway specimens should be collected immediately following removal of the chest plate. Then place specimens into a separate sterile specimen cup containing 10% neutral buffered formalin.

Focused sampling of these tissues, collected by autopsies limited to the chest, or by directed collection accomplished by incision, can be used when deemed appropriate.

If involvement of one or more other organs is suggested by clinical history or laboratory findings obtained prior to death, collection of representative samples of these tissues should be considered. Complete autopsies could be warranted in certain circumstances, as determined by the medical examiner, coroner, or community pathologist. Because COVID-19 can clinically and pathologically resemble other infectious disease processes that involve organ systems in addition to the respiratory tract, representative sections of major organs (i.e., heart, liver, spleen, kidney, and brain) could assist with an alternate diagnosis if tests for SARS-CoV-2 are unrevealing. Collection of tissues from other major organs can also facilitate the evaluation of possible extrapulmonary complications of COVID-19.

Collection of tissue samples approximately 5 mm in thickness (i.e., sample would fit in a tissue cassette) is recommended for optimal fixation. Tissues should be placed in 10% buffered formalin, in a volume that is approximately 10 times greater than the volume of tissue. Optimal fixation is three days (72 hours). Specimens should be shipped to CDC as soon as possible following complete fixation. Prolonged immersion in formalin, particularly if for longer than 4 weeks can diminish the sensitivity of virus detection assays.

Alternately, formalin-fixed, paraffin-embedded tissues (original blocks obtained at autopsy) can be submitted for evaluation.

Handling Specimens Collected at Autopsy

Personnel handling collected specimens and preparing them to be taken out of the autopsy suite should follow Standard Precautions. Specimens must be properly secured according to diagnostic laboratory recommendations and placed in an appropriately labeled leakproof primary container.

• Within the autopsy suite, primary containers should be placed into a leakproof secondary container.

• If possible, the secondary container should then be placed into a resealable plastic bag that was not in the autopsy suite when the specimens were collected.
• The primary and secondary containers and resealable plastic bag should be wiped down with appropriate Environmental Protection Agency (EPA)-approved disinfectantsexternal icon before each subsequent step.
• The resealable plastic bag should then be placed into a labeled biological specimen bag with absorbent material; and then can be transferred outside of the autopsy suite.

Workers receiving the biological specimen bag outside the autopsy suite or anteroom should deliver the specimen in a safe manner to a laboratory staff who can proceed with final packing and shipping procedures.

More information about preparation of specimens for shipment may be found at Interim Laboratory Biosafety Guidelines for Handling and Processing Specimens Associated with Coronavirus Disease 2019 (COVID-19).

Submission of Specimens for SARS-CoV-2 Testing

Medical examiners, coroners, and other healthcare professionals should work with their state, tribal, localexternal icon, and territorial health departments to coordinate testing through public health laboratories. In addition, SARS-CoV-2 testing, authorized by the Food and Drug Administration under an Emergency Use Authorization (EUA)external icon, is available in clinical laboratories.

Submission of Postmortem Swab Specimens to CDC

Postmortem swab specimens may be shipped to CDC for SARS-CoV-2 RT-PCR testing if testing is not available at public health or clinical laboratories in a jurisdiction, or if repeated testing results remain inconclusive, or if other unusual results are obtained. State or local health departments should contact CDC at [email protected] prior to submitting samples to receive approval.

If specimens will ship without delay, store specimens at 2-8°C, and ship overnight to CDC on ice pack. If a delay in shipping will result in receipt at CDC more than 72 hours after collection, store specimens at -70°C or below and ship overnight to CDC on dry ice. Additional useful and detailed information on packing, shipping, and transporting specimens can be found at Interim Laboratory Biosafety Guidelines for Handling and Processing Specimens Associated with Coronavirus Disease 2019 (COVID-19). Specimens must be packaged, shipped, and transported according to the current edition of the International Air Transport Association (IATA) Dangerous Goods Regulationsexternal icon.

Label each specimen container with the patient’s ID number (e.g., medical record number), unique CDC or state-generated specimen ID (e.g., laboratory requisition number), specimen type (e.g., NP swab) and the date the sample was collected. Complete a CDC Form 50.34 for each specimen submitted. In the upper left box of the form, 1) for test requested select “Respiratory virus molecular detection (non-influenza) CDC-10401” and 2) for At CDC, bring to the attention of enter “Unit 84 (Non-flu Resp Virus)-Autopsy”.

Please refer to instructions for submitting CDC Form 50.34 found here: Guidelines For Submitting Specimens to CDC. pdf icon[354 KB, 2 Pages]

For additional information, consultation, or the CDC shipping address, contact the CDC Emergency Operations Center (EOC) at 770-488-7100.

Submission of Fixed Autopsy Tissue Specimens to CDC

Criteria for Fixed Autopsy Tissue Specimen Submission

At this time, CDC’s Infectious Diseases Pathology Branch is accepting tissues fixed in 10% neutral buffered formalin, as well as formalin-fixed, paraffin-embedded (FFPE) tissue blocks obtained at autopsy for SARS-CoV-2 testing from decedents when the following three criteria are met:

1. Clinical or pathologic findings, and epidemiologic history indicate need for COVID-19 testing (i.e., meets criteria A OR B below):
   1. Death occurring on or after 12/1/2019 with clinical or pathologic findings and epidemiologic history consistent with possible COVID-19, but no laboratory evidence of SARS-CoV-2 (i.e., meets all of the following four criteria):
      1. Death occurring on or after 12/1/2019,

      AND

      2. Clinical or pathologic findings suggestive of COVID-19 (i.e., meets criteria a OR b below):
         1. History of fever or one or more other signs or symptoms concerning for COVID-19 (e.g., cough, shortness of breath)

         OR

         2. Histopathologic findings in respiratory tissues consistent with a possible infectious process, including diffuse alveolar damage, pulmonary hemorrhage, interstitial pneumonitis, capillaritis, intravascular leukocytosis, fibrin thrombi, bronchopneumonia, tracheitis, or bronchitis

      AND

      3. SARS-CoV-2 testing on respiratory swab specimens has not been performed, or is negative, inconclusive, or invalid

      AND

      4. No fully explanatory alternative etiology
         1. Decedents may have infectious disease testing positive for one or more other pathogens, but review of clinical, pathologic, and epidemiologic information suggests that COVID-19 should also be considered.

   OR

   2. Death with laboratory evidence of SARS-CoV-2 by antemortem or postmortem testing but with questions regarding the relationship of results to reported clinical history, observed gross or histopathologic findings at autopsy, or the cause of death

AND

2. Adequate specimens are available:
   1. Formalin-fixed (wet) tissues or formalin-fixed, paraffin-embedded (FFPE) tissue blocks from lung and upper airway:
      • If > 4 weeks have elapsed since the autopsy, original FFPE tissue blocks from the time of autopsy are available. for submission.
      • If FFPE tissue blocks are submitted, a minimum of two respiratory tissue blocks is required. However, because viral antigens and nucleic acids can be distributed focally, chances of detection are enhanced considerably when a minimum of 3 blocks of lung and 1 block of large airway (trachea or mainstem bronchus) are submitted for evaluation.
   2. Submission of fixed tissues from other major organs, including heart, kidney, liver, spleen, and brain is not required, but is highly recommended to better evaluate extrapulmonary complications of COVID-19 and to optimize assessment for coinfections or alternative infectious etiologies.

AND

3. Approval of appropriate state or local health department for specimen submission to CDC has been obtained.

Fixed Autopsy Tissue Specimen Pre-Approval and Submission Instructions

For cases meeting the above criteria, follow the steps outlined below to obtain pre-approval from CDC’s Infectious Diseases Pathology Branch to submit specimens for evaluation:

1. Reminder–Healthcare providers, pathologists, medical examiners, and coroners—please first contact your state, tribal, local, or territorial health department for approval for specimen submission to CDC.
2. Contact CDC’s Infectious Diseases Pathology Branch at [email protected] for pre-approval. Include the following information in the email:
   1. Brief clinical history
   2. Description of gross or histopathologic findings in the tissues to be submitted
   3. Listing of available formalin-fixed tissues

In your email correspondence, do not include patient identifiers such as name, date of birth, or medical record number. You must follow all applicable federal, state, tribal, local, and territorial regulations to adhere to patient confidentiality and privacy protections.

3. After you receive email approval from CDC:
   1. Electronically fill, save, and print both pages of the CDC Form 50.34.
      1. A prepopulated CDC Form 50.34  should be provided to [email protected] with the preapproval to submit, including state-specific public health laboratory contact information and the following fields.  Do not change or delete this information:
         1. Test Order Name: “Pathologic Evaluation of Tissues for Possible Infectious Etiologies”.
         2. Test Order Code: “CDC-10365”.
         3. Suspected Agent: “Severe Acute Respiratory Syndrome coronavirus 2 (SARS-CoV-2)”
         4. At CDC, bring to the attention of: “Dr. Sherif Zaki (IDPB/Unit 109)”
      2. Please provide any applicable CDC and State NCOV Case ID numbers in the Comments section on Page 2 of the CDC 50.34 form.
   2. In addition to the CDC Form 50.34, enclose the following in the specimen submission package:
      1. Autopsy report (preliminary is acceptable) or block log
      2. Relevant clinical notes, including admission History and Physical (H&P), discharge summary, if applicable
4. Mailing/Contact Info:
   1. Formalin-fixed wet tissues and/or formalin-fixed, paraffin-embedded tissue blocks should be shipped in suitable packaging at ambient temperature. Do not freeze fixed tissues.
   2. Ship to: Dr. Sherif Zaki, CDC, IDPB, 1600 Clifton Rd NE, MS: H18-SB, Atlanta, GA 30329-4027
   3. Send tracking number to [email protected]
   4. Tel: 404-639-3132, Fax: 404-638-5358, Email: [email protected]

Cleaning and Waste Disposal Recommendations

CDC guidance states that the management of regulated medical waste should be performed in accordance with routine procedures as it has not been implicated in the transmission of SARS-CoV-2, the virus that causes COVID-19. However, autopsy facilities should have a plan compliant with the medical waste management policy describing the procedures of transporting waste out of the autopsy room into a designated accumulation area. Waste should then treated by an incineration method onsite or transported in USDOT-approved containers offsite for treatment.

Regulated Medical Waste and Category B infectious substances are listed in the USDOT Hazardous Materials Regulations (HMR) 49 Code of Federal Regulations 173.197external icon. A special permit issued by the USDOT is not required to transport RMW contaminated with SARS-CoV-2.

The following are general guidelines for cleaning and waste disposal following an autopsy of a decedent with confirmed or suspected COVID-19. Current evidence suggests that SARS-CoV-2 may remain viable for hours to days on surfaces made from a variety of materials.

Use Environmental Protection Agency (EPA)-approved disinfectantsexternal icon that meet the criteria for use to inactivate SARS-CoV-2, the virus that causes COVID-19. Current data suggest that survival time of SARS-CoV-2 on surfaces varies and depends on the type of surface material. Determine the most appropriate disinfectant for the surface or object, specifically for use on hard, non-porous surfaces and for the specific application need. Follow the manufacturer’s instructions for all cleaning and disinfection products (e.g., concentration, application method, contact time).

• Apply the disinfectant as instructed on the disinfectant manufacturer’s label. Ensure adequate contact time for effective disinfection.
• Adhere to any safety precautions or other label recommendations as directed (e.g., allowing adequate ventilation in confined areas and proper disposal of unused product or used containers).
• Avoid using product application methods that cause splashing or generate aerosols.

After an autopsy of a decedent with confirmed or suspected COVID-19, the following recommendations apply for cleaning of the autopsy room (and anteroom if applicable):

• Make sure that ventilation systems are active and operating properly, as described in section Engineering Control Recommendations for Autopsies
• Wear appropriate PPE:
  • Wear disposable gloves recommended by the manufacturer of the cleaner and disinfectant being used.
    • Dispose of gloves if they become damaged or soiled and when cleaning is completed, as described below. Never wash or reuse gloves.
  • Use eye protection.
  • Wear a clean, long-sleeved fluid-resistant gown to protect skin and clothing.
• Wear a NIOSH-approved disposable N95 or higher respirator.
  • If NIOSH-approved N95 or higher-level respirators are used, a comprehensive respiratory protection program in accordance with the OSHA Respiratory Protection standard (29 CFR 1910.134external icon) that includes medical exams, fit testing, and training must be implemented.
  • Ensure workers are trained on OSHA’s Hazard Communication standard, 29 CFR 1910.1200external icon, to communicate with workers about the hazardous chemicals used in the workplace.
  • Additional PPE may be required to protect personnel from potential hazards associated with products that might have been used in autopsy procedures. Use the additional PPE in accordance with the label instructions of the specific product. See CDC Guidelines for Safe Work Practices in Human and Animal Diagnostic Laboratories pdf icon[1.38 MB, 105 Pages] for more information.
  • If PPE is in low supply, consider having personnel who performed autopsies conduct the cleaning and sanitizing of the area.
  • Personnel should follow contingency and crisis strategies during PPE shortages. Refer to Strategies for Optimizing the Supply of PPE.
• Gross contamination and liquids should be collected with absorbent materials, such as towels, by staff conducting the autopsy wearing designated PPE. Gross contamination and liquids should then be disposed of as described below:
  • Use of tongs and other utensils can minimize the need for personal contact with soiled absorbent materials.
  • Large areas contaminated with body fluids should be treated with disinfectant following removal of the fluid with absorbent material. The area should then be cleaned and given a final disinfection.
  • Small amounts of liquid waste (e.g., body fluids) can be flushed or washed down ordinary sanitary drains without special procedures. Waste from sanitary drains is directed to a water treatment plant where it is effectively treated. State regulations may dictate the maximum volume allowable for discharge of body fluids to the sanitary sewer.
• Do not use compressed air and/or water under pressure for cleaning, or any other methods that can cause splashing or might form aerosolized infectious material.
• Follow site-specific standard operating procedures for the containment and disposal of used PPE and regulated medical waste.
• Dispose of human tissues according to routine procedures for pathological waste.
• Sharps containers should be incinerated in a medical waste incinerator.
• Clean and disinfect or autoclave non-disposable instruments, taking appropriate precautions with sharp objects.
• Materials or clothing that will be laundered can be removed from the autopsy suite (or anteroom, if applicable) in a sturdy, leak-proof biohazard bag that is tied shut and not reopened. These materials should then be sent for laundering according to routine procedures. used in healthcare settings.
• Keep camera, telephones, computer keyboards, and other items that remain in the autopsy suite (or anteroom, if applicable) as clean as possible, but treat as if they are contaminated and handle with gloves. Wipe the items after use with appropriate Environmental Protection Agency (EPA)-approved disinfectantsexternal icon that meet the criteria for use against SARS-CoV-2, the virus that causes COVID-19. If being removed from the autopsy suite, ensure decontamination to the extent possible with appropriate disinfectant according to the manufacturer’s recommendations prior to removal and reuse.
• When cleaning is complete and PPE has been removed, wash hands immediately following CDC Hand Hygiene Recommendations.  Avoid touching the face with gloved or unwashed hands.

Cleaning activities should be supervised and inspected periodically to ensure correct procedures are followed.

Handling and Transportation of Human Remains

The risk of transmission of SARS-CoV-2 virus from human remains outside of the autopsy setting is low; however, use standard precautions, including additional PPE if splashing of fluids is expected when handling and transporting human remains.

Combination of PPE that should be used:

• Long-sleeved fluid-resistant or impermeable gown
• Plastic face shield or a surgical mask and goggles
• Nonsterile, nitrile gloves
• Heavy duty gloves over nitrile gloves if there is a risk for cuts, puncture, and penetration of the skin
• NIOSH-approved N95 respirator or higher if there is a risk of aerosols generation while handling human remains

Standard body bagging procedures should be followed, consistent with procedures used for deaths when there is no confirmed or suspected COVID-19. Given the varying weights of decedents and variety, construction, and conditions of body bag materials, postmortem care workers should use prudent judgement determining if risks for puncture, tearing, or failure of body bags could occur and whether a second body bag or a body bag of thicker, stronger material (e.g. minimum of 6 mil thickness) is necessary. Risk factors include:

• Presence of sharp objects on the decedent that could cause punctures or tears (e.g. jewelry, piercings, medical instruments)
• Weight of the decedent that could cause the bag or bag handle to fail during transport (if available, verify body bag weight capacities as provided by the manufacturer)
• Bodily fluids posing exposure risks to workers transporting the body should a puncture, tear, or failure occur (e.g. SARS-CoV-2 has been detected in the feces of some patients diagnosed with COVID-19, though whether the virus in stool is infectious is unknown). Standard Precautions for bloodborne pathogens should always be taken.
• Damage or degradation to the body bag that may have occurred in shipment or storage (e.g. the bag is broken or brittle).

After the body has been bagged, disinfect the outside of the bag with Environmental Protection Agency (EPA)-approved disinfectantsexternal icon that meet the criteria for use against SARS-CoV-2, the virus that causes COVID-19, applied according to the manufacturer’s recommendations.