Dear Doctor: Infection Control Lapse at Life Care Dialysis Center

September 15, 2008

Dear Doctor:

An investigation of hepatitis C virus (HCV) infections conducted by the New York State Department of Health (NYSDOH) suggests that transmission of HCV occurred as a result of receiving dialysis treatments at the Life Care Dialysis Center at 221 West 61st Street, New York, New York. Certain lapses in infection control practices at this facility may have placed patients who received hemodialysis or peritoneal dialysis either in-center or at-home after January 23, 2004, at risk for transmission of hepatitis C virus (HCV), and of other bloodborne infections, including hepatitis B virus (HBV) and human immunodeficiency virus (HIV).

Your patient has been contacted because records indicate that he or she received dialysis through this facility during the period of concern. Each individual's actual risk of infection is impossible to determine. Even though we are not aware of any patients who became infected with HBV or HIV, NYSDOH recommends screening for all three viral infections because of the possibility of their transmission.

Your patient was likely screened for HBV and HCV as a routine part of dialysis treatment, but HIV testing is not routinely performed. Therefore, the NYSDOH recommends your patient be tested now for HIV; if it is within three months of his or her last dialysis treatment at Life Care Dialysis Center, nucleic acid testing (NAT) should be used for the initial test. All serologic testing records for your patient should be reviewed and discussed with your patient. Regardless of previous testing, your patient should be tested for HBV and HCV six months after his/her last dialysis treatment at Life Care Dialysis Center. If not tested within the previous month for HBV and HCV, your patient should also be tested now for HBV and HCV.

The following tests are recommended:

Initial Visit:

  • If not tested within the previous month:
    • Hepatitis B Virus (HBV): Hepatitis B surface antigen (HBsAg), total hepatitis B core antibody (total HBcAb), and hepatitis B surface antibody (HBsAb).
    • Hepatitis C Virus (HCV): Hepatitis C virus enzyme-linked immunosorbent assay (HCV EIA) and, if positive, a confirmatory HCV recombinant immunoblot assay (RIBA) or nucleic acid testing (NAT), such as polymerase chain reaction (PCR).
  • HIV: HIV screening test (standard blood test or rapid testing where available) and, if positive, a confirmatory Western Blot following pre- and post-test counseling and informed consent. NYSDOH Form 2556, the informed consent document, is available for download at http://www.nyhealth.gov/diseases/aids/forms/informedconsent.htm.
    • If it is within three months of the patient's last dialysis treatment at Life Care Dialysis Center, NAAT testing should be used. If only serology is ordered at the initial visit, serology should be repeated at a follow-up visit three months after the patient's last dialysis treatment at Life Care Dialysis Center.

Follow-up Visit (6 months after last treatment at Life Care Dialysis Center):

  • Hepatitis B Virus (HBV): Hepatitis B surface antigen (HBsAg), total hepatitis B core antibody (total HBcAb), and hepatitis B surface antibody (HBsAb).
  • Hepatitis C Virus (HCV): Hepatitis C virus enzyme-linked immunosorbent assay (HCV EIA) and, if positive, a confirmatory HCV recombinant immunoblot assay (RIBA) or nucleic acid testing (NAT), such as polymerase chain reaction (PCR).
  • HIV: No retesting is necessary unless other risk factors dictate the need for testing.

If your patient has previously been diagnosed with HBV, HCV, or HIV, then he or she does not need to be retested for that particular infection. However, he or she should be tested for the other infections.

Any positive result for HBV and/or HCV is reportable to the local health department in which the patient resides, pursuant to the New York State Sanitary Code (10NYCRR 2.10). Any positive result for HIV is reportable to NYSDOH pursuant to Public Health Law 2130. Reporting of positive test results for patients residing outside of New York State will be in accordance with that state's laws regarding reporting of communicable diseases.

Physicians within New York State are required to report using the following procedures:

HBV and HCV:

For residents of New York City (NYC) contact the New York City Department of Health and Mental Hygiene (NYCDOHMH) at 212-788-4390 during business hours. Mention that your patient was tested as part of the Life Care Dialysis Center investigation.

For NYS residents outside of NYC, complete NYSDOH Form 389 and mail to the local health department in the county where the patient resides within 24 hours of receipt of a positive test result. NYSDOH Form 389 is a triplicate form and therefore cannot be downloaded for use. A sample is available for viewing at http://www.health.state.ny.us/forms/doh-389.pdf . To obtain copies of the form, call 518-474-0548. Positive reports for patients residing outside New York State should be reported to the appropriate state or local health jurisdiction where the patient resides.

HIV:

For New York State residents, complete NYSDOH Form 4189 and mail Page 2 (the YELLOW carbon copy) to the NYSDOH Division of Epidemiology at PO Box 2073, ESP Station, Albany, NY 12220-2073 upon receipt of a positive test result. NYSDOH Form 4189 may be obtained by calling 518-474-4284. For newly diagnosed HIV infection related to this investigation, please indicate "dialysis treatment at Life Care Dialysis Center" under "Other risk" in the risk ascertainment section (Box e) of the form. Positive reports for patients residing outside New York State should be reported to the appropriate state or local health jurisdiction where the patient resides.

Reimbursement for all costs associated with testing for these three infections, including office co-pays, is available for patients notified as a result of this investigation. For questions pertaining to scheduling testing or reimbursement, patients should call Life Care's administrative consultant at 866-926-1987, Monday to Friday, between the hours of 9am - 8pm, and Saturday and Sunday, between the hours of 9am – 5pm. No-cost anonymous HIV testing is also available to all individuals through NYSDOH. Phone numbers for these anonymous HIV testing centers are available online at http://www.health.state.ny.us/diseases/aids/testing/sites.htm or by calling 1-800-541-AIDS.

If you have any questions, please call the New York State Department of Health at 1-800-278-2965.

Sincerely,

Richard F. Daines, M.D.
Commissioner of Health

Enclosures: