January 3, 2013 — This article by Lawrence F Muscarella, PhD, discusses a number of infection-control breaches identified at several medical facilities within the past few years.
This article acknowledges that no medical facility is perfect and, like humans, each manifestly commits inadvertent errors and mistakes. The purpose of this article is not to single-out, castigate, or admonish a facility for a having improperly reprocessed reusable medical equipment.
Rather, its intent is purely educational and to discuss five instances of reprocessing breaches, identify their causes (when possible), and provide recommendations — or corrective or preventive actions (CAPAs) — to prevent the breach’s recurrence.
Further, this article features a box article — Box A (below)— that lists a number of recent infection-control breaches; the breach’s assessed risk of infection; and the number of notified patients. This box article indicates that whereas one facility may notified patients due to an infection control lapse it assessed to be associated with an “extremely remote” risk of infection, another facility may not notify patients affected by an infection control lapse assessed to be associated with a seemingly identical “negligible” risk of infection. One facility listed in Box A notified patients of an infection control lapse in 2014 nearly 5 years after its identification in 2008 (click here).
1. CASE 1: St. Louis, Missouri – OPERATING ROOM
Introduction: In early February, 2011, the John Cochran Division of the Veterans Affairs Medical Center (VAMC), located in St. Louis (MO), reportedly identified during a regular inspection “spots” on surgical instrument trays, as well as “water stains” on at least one surgical instrument.1,2
Amid concerns that these anomalies might indicate faulty cleaning and sterilization practices, officials closed this VAMC’s operating suite of 10 procedure rooms. Indeed, improper reprocessing of surgical instruments and trays can pose a significant risk of infection.1-3
Root cause analysis: The specific cause of these visual indicators of apparent instrument contamination has not been determined.1,2,4 Nevertheless, hospital officials have reportedly concluded that these spots and stains were not of blood or another potentially infectious body fluid or material, but were more likely metallic etchings, rust, or corrosive pits on the instruments’ surfaces.2
A root-cause analysis’s determination of all of the factors that might have contributed to, or caused, the spotting and staining of these instruments, however, is crucial. Such an analysis would establish the mitigations—or corrective or preventative actions (CAPAs)—necessary to minimize the likelihood of, if not prevent, this breach’s recurrence.
The determination of each of a breach’s contributing factors is additionally important to evaluate the number of affected patients on whom suspect surgical instruments might have been used.
Patients not at risk: According to hospital officials, the spotting and staining of these surgical trays and (at least one) instrument were this breach’s only instance and did not result in the clinical use of any potentially contaminated instruments.1,2
Consequently, concluding that no cases of disease transmission would have been associated with this breach, patients were not notified of it.2,3 The rationale for the resolute conclusion by officials that this breach did not expose any patients to infectious agents or non-infectious materials—such as HIV, the hepatitis B (HBV) or C (HCV) viruses, or metallic debris, such as rust—however, is unclear.
Table 1 (embedded below, to the right) highlights a number of recommendations that are provided to reduce the risk of infection.
“Great heart and soul”: Nevertheless, because of the potential risk of patient injury, hospital officials cancelled more than 70 surgeries and did not reopen this VAMC’s operating suite until 5 weeks later, in mid-March (2011), once its cleaning and sterilization processes were verified to be functioning properly (see: Table 2, embedded below).4
Raising the rhetoric, a St. Louis newspaper editorialized that there is “no excuse” for such “sloppy sterilization practices,”5 and whereas some have referred to it as a “national disgrace,” others have characterized this VAMC as having “a great heart and soul.”6
The rationale for the resolute conclusion by officials that this breach in St. Louis (MO) did not expose patients to infectious (or non-infectious) materials is unclear.
2. CASE 2: St. Louis, Missouri – DENTAL CLINIC
Faulty cleaning: To many (but not all7), reports of this St. Louis VAMC’s apparent instrument-reprocessing breach would have been a surprise. Less than a year earlier, in March (2010), a similar routine inspection found that for the previous 13 months the dental clinic of this same VAMC (in St. Louis, MO) had been improperly reprocessing dental instruments.8
In response, this VAMC claimed to be “doing everything possible” to prevent such a breach from recurring.8
According to officials, this clinic had failed to use a detergent (as manufacturer instructions require) to clean its dental instruments prior to steam sterilization (see: Table 2, embedded below).8 Improper cleaning of soiled dental (and surgical) instruments poses an increased risk of ineffective sterilization and healthcare-acquired infections.9 (Note: In the summer of 2010, the dental clinic of a different VAMC in the Midwest was closed for three weeks because of similar concerns that infection-control standards may have been breached; see: case 5, below.10)
Although it concluded that the risk of infection was “extremely low,” the VA, nonetheless, notified (via mailed letters) 1812 patients in June, 2010, of this VAMC dental clinic’s breach,8 in accordance with the Veterans Health Administration’s (VHA) patient-disclosure policies.11,12
3. CASE 3: Murfreesboro (TN), Augusta (GA), Miami (FL) – FLEXIBLE ENDOSCOPY:
Fundamental defects: The breaches identified in this St. Louis VAMC’s operating suite (“case 1,” above), like in its dental clinic (“case 2,” above), would not appear to be isolated or necessarily unique. In June, 2009, the VA’s Office of Inspector General (VAOIG) issued a report confirming several instrument-reprocessing and infection-control breaches at a number of VAMCs in other regions of the country.
The VAOIG concluded in this report that these breaches resulted from the failure of medical facilities to comply with alerts and directives, which displayed “fundamental defects” within the VHA that posed “a risk of infectious disease to veterans.”13
This case’s breaches are discussed in a number of other blogs that accompany and complement this blog, and their review is recommended:
- “Improper Set-up and Inadvertent Misuse of a GI Endoscope’s Auxiliary Water System” (click here)
- “Infection Control Breaches Unveiled in Puerto Rico” (click here)
- “Reprocessing the MAJ-855 Auxiliary Water Tube and the GI Endoscope’s Auxiliary Water Channel” (click here)
Improper reprocessing of reusable instruments: The VAOIG confirmed in this report (published in June, 2009) that for as many as 5 years three VAMCs13—located in Murfreesboro (TN), Augusta (GA), and Miami (FL)—had been improperly reprocessing colonoscopes, flexible laryngoscopes and other types of reusable equipment.
Receiving more media focus than any other of these breaches were the Murfreesboro VAMC’s improper use and reprocessing of the Olympus MAJ-855 auxiliary water tube—read the blog by Dr. Muscarella entitled “Reprocessing the MAJ-855 Auxiliary Water Tube and the GI Endoscope’s Auxiliary Water Channel,” which is available by clicking here).
“Presumptive obligation”: As it did for the 1812 patients of the St. Louis VAMC’s dental clinic,8 the VHA disclosed to more than 10,000 patients of these three VAMCs† (located in Murfreesboro, Augusta, and Miami) that these breaches posed an increased risk of infection.13 (These breaches and their associated increased risk of infection are detailed in another article’s Table 2, which can be viewed by clicking here.)
Demonstrating “respect for the patient, professionalism, and a commitment to improving care,” the VHA notified these patients in accordance with its patient-disclosure policies and Directive 2008-002—which emphasize the “ethical,” “legal” and “presumptive obligation” to inform patients of “harmful or potentially harmful” events, even those that “may not be obvious or severe, or where the harm may only be evident in the future.11
The New England Journal of Medicine: This policy of transparency is consistent with the conclusions of a article by Dudzinski et al. (2010).14
Recently published in the New England Journal of Medicine, this article establishes that the notification of patients of an infection-control breach (or another potentially harmful medical error or event) “should be the norm, even when the probability of harm is extremely low.”14
Although such disclosure can incur averse publicity for the healthcare facility, Dudzinski et al. (2010) add that any consequential difficulties to the healthcare facility “are outweighed by (its) obligation to be transparent and to rectify unanticipated patient harm.”14
CASE 4: San Juan, Puerto Rico – FLEXIBLE ENDOSCOPY, TRANS-VAGINAL ULTRASOUND:
Confirmed breaches: The VAOIG published a similar report (click here) in March, 2010, confirming that several medical facilities within the VA Caribbean Healthcare System—like the four aforementioned VAMCs in St. Louis, Murfreesboro, Augusta, and Miami8,13—had been improperly reprocessing reusable medical instruments and equipment.15-17
Specifically, during inspections in the summer of 2009 of a number of medical facilities within this Caribbean healthcare system, which includes a VAMC in San Juan (Puerto Rico), the VAOIG confirmed the:
- failure to high-level disinfect transvaginal ultrasound transducers, or probes;
- improper cleaning of flexible laryngoscopes;
- failure to leak-test colonoscopes and flexible laryngoscopes; and
- use of both damaged and misbranded flexible laryngoscopes.15-17
These breaches and their associated increased increased risk of infection are detailed in another article’s Table 1, which can be viewed by clicking here.)
Negligible” risk? This report by the VAOIG concluded that each of these breaches confirmed within the VA Caribbean Healthcare System posed a “negligible”15-17 risk of infection, and, as a result, affected U.S. veterans were not notified of them. The reader is referred to both the April-May-June, 2010, issue of this newsletter and to a front-page article in the June 24-30, 2010, issue of The San Juan Weekly (click here to read this newspaper article).16,17
The reader is additionally referred to the comparison of several different risk assessments in Box A—which is embedded below, to the right, and which suggests that such assessments of the risk of infection may, in some instances, be more arbitrary than scientific).
CASE 5: Dayton, Ohio – DENTAL CLINIC:
Introduction: Last summer the dental clinic of the VAMC in the Dayton (OH) was closed for three weeks following concerns that infection-control standards may have been breached, posing an increased risk of patient-to-patient disease transmission. Reports indicate that a dentist failed to change gloves between clinical cases and reused dental instruments that had not been sterilized.10 Table 1 (above) provides recommendations to reduce the risk of infection associated with using improperly reprocessed dental instruments.
Box A: 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 — “Case” or reference:
- (reportedly, no risk [1-4]) — (No patients notified) — (“Case 1”);
- “extremely low” (8,12) — 1812 patients — “Case 2”;
- “small but not zero” (13) — More than 10,000 patients — “Case 3”;
- “low but significant risk” (13) — More than 10,000 patients — “Case 3”;
- “substantially < 1 in 10,000” (13) — More than 10,000 patients — “Case 3”;
- “negligible” (15-17) — No patients notified — “Case 4”;
- extremely low (10) — More than 500 patients — “Case 5”;
- “extremely remote”(19) — 9000 patients — Reference No. 19;
- “close to nil”(32) — 150 patients — Reference No. #32;
- “minimal to non-existent”(29) — 360 patients — Reference No. 29;
- “extremely low risk”(31) — 38 patients — Reference No. 31;
- “extremely low”(32) — 15 patients — Reference No. 32; and
- “very, very low” — 18 patients — Reference: click here.
- disease transmission confirmed — 5 patients’ families notified (5 years later) — Reference: click here.
- “highly unlikely” — 3,149 patients —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.
Officials notified more than 500 patients (who had been treated at this VAMC’s dental clinic for more than 18 years), and, although none have tested positive for HIV, seven of these 500 patients have tested positive for HCV and two for HBV.10
Whether these nine cases are a result of patient-to-patient disease transmission caused by this dental clinic’s breaches (or an un-related event) is unclear.10 In addition to Table 1 (above), the reader is referred to the discussion provided in Table 2 (above).
COMMENTARY: A distinction without a difference? The VHA’s decision not to notify patients of the VA Caribbean Healthcare System’s several confirmed breaches is understandably controversial and confusing for a number of reasons, several of which are discussed in another, accompanying blog that can be read by clicking here.
One reason not discussed in this other, accompanying blog is the contrast between, on the one hand, the VHA’s (and VAOIG’s) conclusion that these breaches within the VA Caribbean Healthcare System posed a negligible15 infection risk not warranting patient notification (see: “case 4,” above), and, on the other, the VHA’s conclusion that the breach confirmed at the St. Louis VAMC’s dental clinic (see: “case 2,” above)—like a Canadian hospital’s recent breach*—posed an “extremely low”8 infection risk (and a “phenomenally remote”18 chance of ineffective sterilization) warranting the notification of 1812 patients.
* A hospital’s failure to disinfect a colonoscope’s auxiliary water channel was assessed by Canada’s Interior Health Authority (IHA) to pose an “extremely remote”(19) infection risk, causing the HAI to notify 9000 patients of this breach, in December, 2010, “in the interest of transparency” (see: Box A).(19)
Listed in Box A (above), negligible, extremely low, extremely remote,* and minimal to non-existent** risks of infection are ordinarily assessments without differences, and to distinguish between them might be to split hairs. If for no other reason than consistency and as a precaution, the notification of patients of a breach associated with one of these risk assessments would seemingly warrant the notification, too, of patients of a breach associated with any of the others.
In short, Box A‘s risk assessments — including the notification of 15 patients in New England in September, 2013, of the extremely remote risk of Creutzfeldt-Jakob Disease due to the reuse of potentially contaminated instruments — argue for the notification of patients of any confirmed infection control breach, no matter the risk of patient harm.(32)
** A medical center in Louisiana (USA) notified 360 patients in January, 2011, of the improper disinfection of bronchoscopes and GI endoscopes that, according to this center, posed a “minimal to non-existent” infection risk (see: Box A, above).28,29
Respectfully, however, it appears that the VHA would disagree, having distinguished between these risk assessments and concluded that a breach associated with an extremely low risk of infection—for example, case 2, above, about which 1812 patients were notified—is different from and apparently poses a significantly greater risk of patient harm8 than a breach associated with a negligible infection risk—for example, case 4, above, about which no patients were notified.15
In short, it is confusing, if not incongruous and unsound, that affected patients were not notified of the VA Caribbean Healthcare System’s several confirmed breaches. As a precaution and in accordance with the VHA’s other published risk assessments, patient-disclosure policies, and directives, notification of these affected patients is recommended.11,15
RECOMMENDATIONS: Several highlighted recommendations are provided in Table 1 (embedded above) to reduce the risk of healthcare-acquired infections associated with the specific types of breaches recently identified at a number of medical facilities within the U.S. (and Caribbean) and which are discussed herein. This table’s listing of these recommendations complements, and is neither all inclusive nor a replacement for, manufacturers’ instructions.
This article’s references are available by clicking here.
Article by: Lawrence F Muscarella, PhD, posted on 1-3-2013; updated 5/17/2014.