Anaplasmosis, a tick-borne illness that can be fatal, is not screened for in blood transfusions.

“There is no FDA-licensed test to screen blood donors for Anaplasma,” according to the New York State Department of Health. The state licenses and regulates blood banks.

The federal Food and Drug Administration currently requires testing for: Hepatitis B and C viruses; Human Immunodeficiency Viruses, Types 1 and 2; Human T-Lymphotropic Virus, Types I and II; Treponema pallidum (Syphilis); West Nile Virus; Trypanosoma cruzi (Chagas disease); and most recently Zika virus, according to an emailed response from the FDA handled by spokeswoman Lyndsay Meyer.

Anaplasmosis, the second-most common tick-borne illness in New York State, behind Lyme, infects about 500 New Yorkers annually, according to Bryon Backenson, with the New York State Department of Health. In 2010, anaplasmosis was made reportable as its own unique disease, according to the state’s health department. The health department shows those numbers more than doubling, from 335 cases of anaplasmosis in 2012, to 783 cases in 2015.

The national Centers for disease Control says the highest proportion of fatal cases of anaplasmosis were reported in 2003 when more than 3 percent of those with the disease died. In other years, the fatality rate was around half a percent — one person out of 200 with anaplasmosis died.

Backenson said “a few” people with anaplasmosis in New York State had died.

Next most frequent is babesiosis, which affects about 400 New Yorkers a year, Backenson said.

Most of the screening that the FDA does for donated blood is conducted the same way across the country, but the administration can screen for certain regional diseases — like anaplasmosis — in only the areas where they occur.

“For example,” The FDA said in a written response to questions, “FDA has proposed that regional testing for Babesia microti  parasites (the pathogens that cause babesiosis – a disease with malaria-like symptoms) may be acceptable when an appropriate screening test is available.

“Since 2008, FDA has addressed in public settings the issue of transfusion-transmitted babesiosis, including at a 2010 Blood Products Advisory Committee meeting.  Based on the information available at that time, the Committee recommended the concept of selective, regional testing of blood donors for Babesia. The Committee did not provide advice on the question of most suitable technologies for donor screening for Babesia. However, donor screening policies for B. microti are under current consideration at FDA.”

According to the state’s health department, “Because New York State is an endemic area, donors are also being tested for babesiosis, which is not required by the state or by the federal Food and Drug Administration but is recommended. Zika testing is in the process of being set up now; it is currently strongly recommended but not required.”

Safeguards

Asked how it is decided what diseases to screen for, the FDA responded, “The Department of Health and Human Services (HHS) and the Public Health Service (PHS) agencies (National Institutes of Health (NIH),  FDA, Centers for Disease Control and Prevention (CDC)) routinely monitor for potential threats to blood safety from new and re-emerging infectious agents. These government agencies cooperate closely to ensure that there is awareness of emerging infectious threats, that relevant research is performed as needed, and that appropriate interventions are put in place.

“While there is overlap, CDC has a primary responsibility for surveillance and risk assessment; NIH is charged with basic research; and FDA is responsible for regulating blood products, including establishing policies that reduce the risk of transfusion-transmitted infection.”

To require testing, the FDA must first show that the transfusion-transmitted infection may have sufficient incidence or prevalence to affect blood donors. The FDA would then require testing if certain criteria are met, including the “availability of an appropriate screening test that has been licensed, approved, or cleared for such use by FDA and testing is necessary to reduce the risk of transmission of the infection by transfusion of the blood component,” the FDA said.

The FDA says it has “established overlapping safeguards designed to protect the blood supply — including requirements to determine that the donor is in good health and free from transfusion-transmitted diseases before collection; testing blood donations for certain relevant transfusion-transmitted infections; maintaining a list of deferred donors; and keeping blood in quarantine until the testing is complete.”

Also patients can donate their own blood — called an “autologous donation” — ahead of a procedure “provided the donor meet certain eligibility criteria and the donor has a prescription for the donation from their physician,” the FDA said.

Blood establishments and transfusion services are required to “maintain records of complaints of adverse reactions regarding each unit of blood or blood product arising as a result of blood collection or transfusion reaction,” the FDA said. The facilities are also required to investigate each reported adverse reaction and document the investigation.  If a complication of the blood collection or transfusion is confirmed to be fatal, it must be reported to FDA within seven days after the fatality by the collection facility in the event of a donor reaction, or by the facility that performed the compatibility tests in the event of a transfusion reaction.

The American Association of Blood Banks, American Red Cross, and America’s Blood Centers are blood bank industry associations.

The FDA concluded, “Over a period of years, FDA has progressively strengthened the overlapping safeguards that protect patients from unsuitable blood and blood products.”