CS 311294-C 01/15/2020

SPECIMEN SUBMISSION GUIDANCE FOR PATHOLOGIC 

EVALUATION OF AUTOPSY TISSUE SPECIMENS FROM 

DEATHS WITH SUSPECTED E-CIGARETTE, OR VAPING, 

PRODUCT USE-ASSOCIATED LUNG INJURY (EVALI)

Pathologic findings in lung tissue from cases of e-cigarette, or vaping, product-use associated lung injury 

(EVALI) have included patterns of acute lung injury, such as diffuse alveolar damage, organizing pneumonia, and 

acute fibrinous and organizing pneumonia. Acute lung injury can have many different causes, including EVALI, 

but also infectious etiologies. In the setting of deaths in individuals with a history of e-cigarette, or vaping, 

product use, who had antecedent respiratory, gastrointestinal, or constitutional symptoms, or for whom EVALI is 

otherwise suspected, autopsies should be considered. CDC’s Infectious Diseases Pathology Branch can provide 

assistance in the evaluation of fixed autopsy tissue specimens from deaths with suspected EVALI. 

AUTOPSY TISSUE SPECIMENS

CDC can receive formalin-fixed, paraffin-embedded 

(FFPE) tissue blocks or formalin-fixed (wet) tissues 

from autopsy for evaluation. Preferred specimens for 

submission to CDC include:

1. Lung parenchyma, trachea and bronchi.

2. Liver

3. Kidney

4. Heart

5. Other organs showing significant gross or 

microscopic pathology. 

Respiratory tissues should be thoroughly sampled. 

Since influenza and other respiratory viral infections 

may be in the differential diagnosis, submission 

of tissues from the trachea and central lung with 

segmental and primary bronchi in addition to the lung 

parenchyma is encouraged. Viral antigens and nucleic 

acid may be focal or sparsely distributed in patients 

with influenza, and are most frequently detected in 

respiratory epithelium of these larger airways. 

Because the pathology of acute lung injury and 

related death is often systemic, preferred specimens 

for submission to CDC also include tissues from other 

major organs.

LUNG BIOPSY TISSUE SPECIMENS

Fixed lung biopsy tissue specimens may also be submitted on a limited case-by-case basis if there is a specific 

suspicion for a possible infectious disease etiology.

EVALUATION AT CDC

CDC’s Infectious Diseases Pathology Branch will review tissue histopathology and perform additional 

testing, including testing for possible infectious etiologies by special stains, immunohistochemistry (IHC) 

and molecular testing, as indicated. Note that if infectious disease testing is desired, FFPE tissue blocks are 

preferred if formalin-fixation of the wet tissues has exceeded 2 weeks. Prolonged formalin-fixation can lead to 

degradation of antigens and nucleic acids, reducing the sensitivity of infectious disease assays. 
SUBMISSION OF SPECIMENS

Pre-approval is required prior to submission of any tissue specimens. For pre-approval, please contact 

Pathology@cdc.gov (see below for additional guidance).

FORMALIN-FIXED (WET) TISSUE

Place tissue in 10% buffered formalin for three days (72 hours) for biopsies, and a week for thinly-sliced 

autopsy tissues. The volume of formalin used to fix tissues should be 10x the volume of tissue.

FORMALIN-FIXED, PARAFFIN-EMBEDDED (FFPE) TISSUE BLOCKS 

In general, this is the preferred specimen for infectious disease testing, and is especially important to submit 

in cases where tissues have been in formalin for a significant time. Prolonged fixation (>2 weeks) may interfere 

with some immunohistochemical and molecular diagnostic assays.

INFECTIOUS DISEASES PATHOLOGY BRANCH SPECIMEN 

SUBMISSION REQUIREMENTS

A. Healthcare providers, pathologists, medical 

examiners, and coroners—please first report 

any suspected cases of lung injury associated 

with e-cigarette product use to your state, 

tribal, local, or territorial health department 

B. Health departments—contact Pathology@cdc.

gov with

1. A brief clinical history 

2. A listing of available formalin-fixed specimen 

types including tissue source and if formalinfixed (wet) tissue, FFPE tissue blocks, or slides 

are available 

3. Description of histopathologic findings in 

tissues to be submitted 

4. CDC Case ID (used by state epidemiologists 

for submitting case data to CDC) and State 

Case ID numbers. Email correspondence 

should not include patient identifiers such 

as name, date of birth, or medical record 

number. All applicable federal, state, and local 

regulations must be followed to adhere to 

patient confidentiality and privacy protections. 

C. After you receive approval by email to submit 

the case to CDC’s Infectious Diseases Pathology 

Branch (IDPB) 

1. Electronically fill, save, and print both 

pages of the Specimen Submission Form 

CDC 50.34. 

a. The form must be filled electronically to 

generate three bar-codes required for 

accessioning 

b. E-mail addresses of the Original and 

Intermediate submitters (if any) are 

mandatory fields 

2. Select Test Order Code CDC-10365 

(Pathologic Evaluation of Tissues for 

Possible Infectious Etiologies). 

3. Enter “E-cigarette, or Vaping, Product 

Use Associated Lung Injury” and provide 

CDC and State Case ID numbers in the 

Comments section on Page 2 of the CDC 

50.34 form. 

4. In addition to the CDC 50.34 form, enclose 

the following in the specimen submission 

package: 

a. Surgical pathology, autopsy report 

(preliminary is acceptable), or both 

b. Relevant clinical notes, including 

admission History and Physical (H&P), 

discharge summary, if applicable

(continued on page 3)
D. Packaging and container guidance

1. If formalin-fixed (wet) tissues are being submitted, there are restrictions on the amount of formalin 

that can be shipped. Small quantities (inner container less than 30 ml, with a maximum net quantity 

of 1 L for the entire package) are allowable. 

2. For shipping purposes, you may:

a. Drain off almost all the formalin, leaving enough to keep the tissue moist

b. Place leakproof jar(s) in double Ziploc bags prior to shipping, and add absorbent material to the 

outer bag (alternatively, heat-sealable bags can be used)

c. Ship for overnight delivery if possible

E. Guidance for specimen labeling

1. Please ensure that the formalin-fixed (wet) tissue specimen containers/bags and formalin-fixed 

paraffin-embedded tissue blocks are labeled with two primary patient identifiers (i.e., first and last 

name, date of birth, unique patient identifier from time of collection, such as surgical pathology 

number, autopsy number, or medical record number). 

2. The patient identifiers on the specimen containers/bags or specimens should match the patient 

identifiers listed on the CDC 50.34 Form, Surgical Pathology Report, Autopsy Report, and/or other 

medical records submitted with the specimen(s). 

3. Specimens without adequate labeling are subject to delay in accessioning and testing.

F. Mailing contact information

1. Ship to Dr. Sherif Zaki, CDC, IDPB, 1600 Clifton Rd NE, MS: H18-SB, Atlanta, 

GA 30329-4027

2. Mail in suitable packaging for delivery Monday to Friday, excluding Federal holidays

3. Send tracking number to Pathology@cdc.gov

4. Tel: 404-639-3132, Fax: 404-639-3043, Email: Pathology@cdc.gov

For more information on shipping instructions and specimen handling, see: 

https://www.cdc.gov/laboratory/specimen-submission/detail.html?CDCTestCode=CDC-10365

Digital slides or microscopic images can also be submitted for an informal, image-only consultation

(i.e., no patient report will be issued). Contact epathology@cdc.gov and see 

https://www.cdc.gov/ncezid/dhcpp/idpb/epathology/index.html for more information. 

For more information on CDC’s Infectious Diseases Pathology Branch, see: www.cdc.gov/pathology

Updated 1/13/2020