December 11, 2012 (updated 8-5-2014): The Veterans Health Administration’s (VHA) decision in 2009 not to notify patients of the several infection-control breaches confirmed within the VA Caribbean Healthcare System, which includes a VA Medical Center (VAMC) in San Juan (PR), is controversial for a number of reasons.
A front-page newspaper article, dated June 2010, discussing this decision and its surrounding circumstances may be read by clicking here.
First, the medical literature and a guideline by the Centers for Disease Control and Prevention(9) (CDC) suggest that the infection-control breaches confirmed within the VA Caribbean Healthcare System in 2009 pose an increased infection risk(16) — notwithstanding both the VAOIG’s assessment that they pose a “negligible” infection risk or the VHA’s notification of 1069 patients of the similar failure by the Augusta (GA) VAMC to high-level disinfect semi-critical instruments.(13)
These confirmed errors included the failure to high-level disinfect semi-critical instruments(15).
Remember: Click here to read Dr. Muscarella comments in a front-page newspaper article discussing the VHA’s decision not to inform affected patients of these infection-control breaches.
Moreover, on balance, several of these confirmed breaches might pose more of an infection risk than some of those confirmed at the three VAMCs in Murfreesboro, Augusta, and Miami (refer to the more detailed article Dr. Muscarella wrote by clicking here), in 2009, about which the VHA notified more than 10,000 patients. See: Table 1, below.
For example, whereas the Murfreesboro VAMC’s improper use and reprocessing of an auxiliary water tube, to date, has not been linked to patient infections,(20) the failure to leak-test flexible endoscopes (which was one of the VA Caribbean Healthcare System’s confirmed breaches) has been previously associated with patient morbidity and mortality.(16)
Click here to read Dr. Muscarella’s related article “Improper Use and Reprocessing of a Gastrointestinal Endoscope’s Auxiliary Water System,” which discusses, in detail, the Murfreesboro VAMC’s improper use and reprocessing of an auxiliary water tube.
What’s more, this healthcare system’s improper disinfection of transvaginal ultrasound transducers reportedly poses an increased risk of infection of, among other agents, the human papillomavirus (HPV).(16)
Click here to read Dr. Muscarella’s comments about patient notification in the Winston-Salem Journal’s article “Hospitals take different approaches on disclosure” published in March, 2014.
Table 1: Distinctions with, or without, a differences? Assessments of the risk of infection associated with a number of identified infection-control breaches. A “case” refers to the five discussed in the main article.
Risk assessment — No. patients notified — Reference number:
- (Reportedly, no risk) — (No patients notified) — References: 1-4;
- “Extremely low” — 1812 patients — References: 8,12;
- “Small but not zero” — More than 10,000 patients — Reference: 13;
- “Low but significant risk” — More than 10,000 patients — Reference: 13;
- “Substantially < 1 in 10,000” — More than 10,000 patients — Reference: 13;
- “Negligible” — No patients notified — References: 15-17
- Extremely low — More than 500 patients — Reference: 10;
- “Extremely remote” — 9000 patients — Reference: 19;
- “Close to nil”(32) — 150 patients — Reference: 32;
- “Minimal to non-existent”(29) — 360 patients — Reference: 29;
- “Extremely low risk”(31) — 38 patients notified — Reference: 31;
- “Extremely low”(32) — 15 patients notified — Reference: 32; and
- “Very, very low” — 18 patients notified — Reference: click here.
- Disease transmission confirmed — 5 patients’ families notified (5 years after the outbreak) — Reference: click here.
Note: Showing a concerning lack of standardization, whereas infection control breaches assessed to have a “negligible infection risk did not result in patient notification (see list, above), others associated with similar infection risks did result in such patient disclosure. The references to Table 1 are provided here.
Second, whereas it did not notify affected U.S. veterans of the VA Caribbean Healthcare System’s failure to use a detergent to clean flexible laryngoscopes prior to high-level disinfection,(15,16) the VHA notified 1812 patients of the similar failure by the St. Louis VAMC’s dental clinic to use a detergent to clean dental instruments prior to steam sterilization,(8) which is confusing.
Third, the VHA’s failure to notify affected patients of this Caribbean healthcare system’s several confirmed breaches is inconsistent with:
- the VHA’s published “obligation” to notify patients of such potentially adverse medical events;(11)
- the VAOIG’s published commitment to “transparency”;(21)
- the VA’s mission to “protect the interest of veterans”;(22) and
- “duty-based frameworks.”(14)
Like the VHA’s published policy of a “presumptive obligation” (refer to Dr. Muscarella’s related article “Recommendations to Prevent Infections Associated with Improperly Reprocessed Reusable Medical Equipment” for a more detailed discussing this “obligation” by clicking here), Dudzinski et al. (2010) state that:
“health care institutions have a duty to inform patients when the delivery of health care has put them at risk.”(14)
And, fourth, having not notified or monitored for infection those patients who were potentially affected by the VA Caribbean Healthcare System’s several breaches, the VHA cannot be assured that there were no cases of disease transmission.(14)
In closing, it can be respectfully argued that the VAOIG’s (and VHA’s) assessment that this healthcare system’s breaches did not pose a sufficient infection risk to warrant patient disclosure is unsound.
The references to this article may be read by clicking here.
Article by: Lawrence F Muscarella PhD posted on 12-11-2012; updated 8-5-2014.