Infections occur frequently in transplant patients. Questions 428-440 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.

Questions 428-436: Did the recipient develop a clinically significant infection since the date of 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 428 and skip to question 437.

Do not report the following scenarios:

  • Culture-negative neutropenic fever without clear source;
  • Suspected (unconfirmed) viral or bacterial infections;
  • Upper respiratory infections which are presumed viral, but no virus has been identified;
  • Candida detected in oral or stool samples (includes oral thrush);
  • Toe nail 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.

Systemic inflammatory response syndrome and septic shock may be diagnosed with or without an organism identified by relevant testing. In either case, a clinical diagnosis of these complications will be reported in questions 437- 440. If an organism is identified by molecular report, laboratory report, or other physician documentation, the infection should be reported in questions 428-436. 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 questions 428-436.
  • If a bacterial or viral infection is suspected, but not confirmed, do not report an infection in questions 428-436.
  • If no particular organism group is identified or suspected, do not report an infection in questions 428-436.

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

Definitions for Same Infection

Organism:

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. If a fungal infection is suspected, but not identified, report using code “503 – Suspected fungal infection.” As noted above, only report infections which are clinically significant.

Reporting the following infections, will cause a Fungal Infection Post-HCT Data Form (Form 2146) to come due:

  • 211 Aspergillus flavus
  • 212 Aspergillus fumigatus
  • 213 Aspergillus niger
  • 210 Aspergillus, NOS
  • 215 Aspergillus terreus
  • 214 Aspergillus ustus
  • 270 Blastomyces (dermatitidis)
  • 201 Candida albicans
  • 208 Candida non-albicans
  • 222 Cryptococcus gattii
  • 221 Cryptococcus neoformans
  • 230 Fusarium (all species)
  • 261 Histoplamsa (capsulatum)
  • 241 Mucorales (all species)
  • 242 Rhizopus (all species)
  • 272 Scedosporium (all species)
  • 240 Zygomycetes, NOS
  • 503 Suspected fungal infection

Reporting the following infections will cause a Hepatitis Serology Post-HSCT Data Form (Form 2147) to come due:

  • 307 Hepatitis B Virus
  • 308 Hepatitis C Virus

Reporting the following infections will cause a Human Immunodeficiency Virus Post-HSCT Data Form (Form 2148) to come due:

  • 309 Human Immunodeficiency Virus 1 or 2

Site:
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 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 or serum 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.

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

Infection Reporting Scenarios:

A. A recipient’s post-HCT CMV testing was consistently negative until 1/10/2015 when CMV PCR testing found 15,000 copies of the virus in the recipient’s peripheral blood. On 1/20/2015, the CMV PCR detects 2000 copies. The CMV PCR is still positive on 1/30/2015, but is documented as “detected but not quantifiable”. From 2/7/15, all subsequent CMV PCRs are negative until 6/3/2015 when the CMV PCR demonstrates 1300 copies.

The center should report one instance of questions 429-436 to capture the CMV infection first documented on 1/10/2015. A second instance of questions 429-436 should also be reported to capture a recurrent CMV infection documented on 6/3/2015. This is >60 days after PCR testing reverts to negative and is therefore considered a recurrence and not the same infection per the guidelines in the Definitions for the Same Infection table above. The recurrent infection would be reported on a subsequent Post-Infusion Data Form if it is diagnosed after the date of contact for the form being completed.

B. A recipient with concerning respiratory symptoms undergoes a bronchiolar lavage on 10/1/2014. A culture performed on the sample collected from the procedure revealed a Streptococcus, Group B infection. The recipient received systemic antibacterial antibiotics, but the infection progressed to their blood as demonstrated by a culture performed on sample collected 11/1/2014. The recipient did not have any repeat cultures performed between their initial diagnosis and testing performed on 11/1/2014.

The center should report one instance of questions 429-436 to capture the Streptococcus, Group B infection. The diagnosis date is the date of the first positive culture performed on the sample collected 10/1/2014.

  • If the positive culture from 11/1/2014 was collected during the same reporting period, “lung” and “blood” should both be reported as sites of infection.
  • If the positive culture from 11/1/2014 was collected after the date of contact for the current reporting period, do not report “blood” as a second site of infection.

C. A recipient is empirically diagnosed with septic shock on 8/15/2013, though cultures and viral tests are consistently negative. The recipient is treated with multiple antimicrobial agents which eventually leads to a resolution of all symptoms / complications. The organism responsible for the suspected infection is never identified.

As no organism was identified, the only scenario in which the center should report this as an infection in questions 428-436 is if there is documentation confirming a suspected fungal infection. In any case, the clinical diagnosis of septic shock will be reported in questions 439-440.

Question 437-438: Did the recipient develop Systemic Inflammatory Response Syndrome (SIRS) since the date of last report?

Systemic inflammatory response syndrome refers to unregulated inflammation which may or may not be related to an infection. If SIRS was clinically diagnosed during the reporting period, report “yes” for question 437 and indicate the diagnosis date in question 438.

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

Question 439-440: Did the recipient develop septic shock since the date of last report?

Septic shock refers to the failure to maintain sufficient mean arterial pressure without intervention with vasopressors. It results from vasodilation associated with infection. If septic shock was clinically diagnosed during the reporting period, report “yes” for question 439 and indicate the diagnosis date in question 438.

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

Last modified: 2018/10/01

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