Infections occur frequently in recipients of cellular therapy or transplant. Questions 171-175 are intended to capture detailed information on clinically significant infections diagnosed during the reporting period. A single infection may be found on multiple cultures or at multiple sites. Infections may recur following resolution of symptoms and negative testing. Use the instructions provided in this section to determine when an infection should be considered clinically significant, and therefore reported, as well as when to report new and / or recurrent infections.

Question 171-175: Did the recipient develop a clinically significant infection since the date of the last report?

Indicate whether the recipient developed a clinically significant bacterial, viral, or fungal infection during the reporting period. For the purpose of this manual, the term “clinically significant” refers to any infection requiring treatment. Surveillance cultures in which normal flora is present and the recipient is asymptomatic do not need to be reported. If no clinically significant infections occurred during the reporting period, report “no” for question 171 and skip to question 176.

Do not report the following scenarios:

  • Culture-negative neutropenic fever without clear source;
  • Upper respiratory infections which are presumed viral, but no virus has been identified;
  • Candida detected in oral or stool samples (includes oral thrush);
  • Toenail fungus;
  • Yeast infection in the groin, vagina, or under the breasts;
  • Surveillance cultures in which normal flora is present and the recipient is asymptomatic;
  • Infections persisting from a prior reporting period (including infections which have progressed to new sites since the last report); or
  • Infections recurring within the time frames specified in the Definitions for Same Infection table below.

If an organism is identified by molecular report, laboratory report, or other physician documentation, the infection should be reported in questions 172-175. If no organism is identified, the center should use the following guidelines to determine whether to report an infection:

  • If a fungal infection is suspected (per radiology assessments), but no organism is isolated during the reporting period, report the suspected infection in question 172 – 175.
  • If no particular organism group is identified or suspected, do not report an infection in question 172 – 175.

For each infection, report the organism, site, and date of diagnosis.

Select the identified or suspected organism as reported on the microbiology report, laboratory report, or other physician documentation.

If the specific organism is not listed, use the code 777 – Other organism and report the name of the organism in the space provided.

In some cases, an infection may be suspected but significant enough to be treated. If a fungal, bacterial, or viral infection is suspected, but not identified, report using code 502 – Suspected bacterial infection, 503 – Suspected fungal infection or 504 – Suspected viral infection. As noted above, only report infections which are clinically significant.

Infections can occur virtually anywhere. In order to capture sufficient detail without excess burden, there is a list for the potential sites. An infection may occur in more than one site at the same time or at different times.

  • If the infection is identified at multiple sites with the same organism and within the recurrence interval to be considered the same infection (Definitions for Same Infection table), please report all sites the organism was identified.
  • If the infection is identified at multiple sites with an organism already reported but is outside of the recurrence interval to be considered the same infection, please report as a new infection.

Select the site(s) of the infection from the options provided on the form. Report all sites of infection which were confirmed by microbiology, laboratory report, or other physician documentation during the reporting period. This includes any new sites identified after the date of diagnosis as well as after treatment has been initiated.

For clarification, the following site definitions are provided:

Blood: includes blood obtained from a central IV line, catheter tip, or from a direct needle stick (Peripheral draw). Blood should be the reported site for infections identified in the bone marrow.

Bone: an infection in the bone itself (Osteomyelitis)

CNS: includes CSF (cerebrospinal fluid) specimens as well as abscesses and/or inflammation noted on brain imaging (encephalitis, meningitis)

Eyes: includes infection in any part of the eye (i.e. retinitis)

Genital: includes vagina, penis, perineum, ovaries, scrotum, testes, uterus

GI tract, lower: includes jejunum, ileum, colon, rectum, and stool

GI tract, upper: includes mouth, dentition, esophagus, stomach, and duodenum

Joints: includes fibrous connective tissue and cartilage at any site of bone articulation, typically isolated to a single area (i.e., not a diffuse infection) such as the knee, elbow, or shoulder

Liver/Spleen: includes the gallbladder and biliary tract

Lung: also known as the lower respiratory tract

Skin, cellulitis: a spreading bacterial or viral infection of the skin and tissues beneath the skin

Skin, necrotizing fasciitis: a severe bacterial infection of the fascia, the tissues that line and separate muscles, that causes extensive tissue death including damage to skin and overlying tissues
Sinus and/or upper respiratory tract: all areas from the nose to the throat and sinuses, does not include lungs (report as “Lung”), mouth, or dental infections (report mouth and dental as “GI tract, upper”).

Urinary tract, lower: includes urinary tract infections and cystitis (bladder inflammation)

Urinary tract, upper: includes the kidneys and ureters

Date of Diagnosis:
Report the date of diagnosis of the infection as the collection date for the positive microbiology culture or laboratory report. For suspected fungal infections, enter the date of a radiological test or the date treatment was started as the date of diagnosis. If multiple sites of infection are identified during the reporting period, report the collection date of the first positive microbiology culture or laboratory report.

Copy and complete questions 172-175 to report more than one infection during this reporting period.

For more information regarding reporting partial or unknown dates, see General Instructions, General Guidelines for Completing Forms.

Question 176: Was a vaccine for COVID-19 (SARS-CoV-2) received since the date of last report?

Indicate if the recipient received a vaccine for COVID-19 (one dose without a planned second dose, first dose with planned second dose, and/or second dose) since the date of last report.

If the recipient did not receive a vaccine for COVID-19 or it is not known if the recipient received a vaccine, select No or Unknown, respectively, and continue with question 183.

Questions 177-180: Select dose(s) received (check all that apply)

Select the vaccine dose(s) the recipient received during the current reporting period (check all that apply) and report the date when the vaccine was received. If the exact date is not known, use the process described in the General Instructions, General Guidelines for Completing Forms and select Date Estimated.

Questions 181-182: Specify vaccine type

Specify the type of vaccine the recipient received. If the vaccine type is not listed, select Other type and specify in question 182.

Section Updates:

Question Number Date of Change Add/Remove/Modify Description Reasoning (If applicable)
. . . . .
Last modified: Jul 23, 2021

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