Department of Veterans Affairs
	

Office of Inspector General
	

Healthcare Inspection
 

Reprocessing of Dental Instruments
 

John Cochran Division of the
 

St. Louis VA Medical Center
 

St. Louis, Missouri
 

Report No. 10-03346-112 March 7, 2011
	 VA Office of Inspector General
	

Washington, DC 20420
	
To Report Suspected Wrongdoing in VA Programs and Operations: 

Telephone: 1-800-488-8244 

E-Mail: vaoighotline@va.gov
	

(Hotline Information: http://www.va.gov/oig/contacts/hotline.asp) 
Reprocessing of Dental Instruments, John Cochran Division of the St. Louis VAMC, St. Louis, Missouri

Contents
	

Page
	

Executive Summary ..............................................................................................i
 

Purpose 

Appendixes
	

.................................................................................................................1
 

Background ..........................................................................................................1
 

Scope and Methodology......................................................................................8
 

Inspection Results ...............................................................................................9
 

Pre-treatment and Cleaning of Dental Reusable Medical Equipment............................. 9
 

Standard Operating Procedures ....................................................................................... 9
 

Staff Training and Competencies .................................................................................... 9
 

Oversight of Supply, Processing, and Distribution Functions....................................... 10
 

Patient Notification Processes ...................................................................................... 10
 

Conclusions........................................................................................................11
 

Recommendations .............................................................................................12
 

Comments...........................................................................................................12
 

A. VISN Director Comments ....................................................................................... 13
 

B. Medical Center Director Comments ........................................................................ 14
 

C. OIG Contact and Staff Acknowledgments............................................................... 17
 

D. Report Distribution .................................................................................................. 18
 

VA Office of Inspector General
Reprocessing of Dental Instruments, John Cochran Division of the St. Louis VAMC, St. Louis, Missouri

Executive Summary
	

The VA Office of Inspector General Office of Healthcare Inspections received a request 

from Congressman Bob Filner, the then Chairman of the House Committee on Veterans’ 

Affairs, Congressman Jeff Miller, current Chairman of the House Committee on 

Veterans’ Affairs, and seven other members of Congress, calling for an inspection into 

reports that veterans in several states including Missouri could have been exposed to 

blood borne pathogens such as hepatitis B (HBV), hepatitis C (HCV), and human 

immunodeficiency virus (HIV) while receiving dental care at the John Cochran Division 

(JCD) of the St. Louis VA Medical Center (STLVAMC), St Louis, MO. 

The purpose of this review was to determine the sequence of events involving alleged 

improperly cleaned and sterilized dental reusable medical equipment (RME); errors in 

reprocessing or sterilization; actions taken to correct deficiencies; and decisions related to 

patient notification of breaches in dental equipment reprocessing or sterilization at the 

STLVAMC. 

The dental RME reprocessing issues at the JCD were a long-standing problem that went 

unrecognized and unaddressed by Veterans Integrated Service Network (VISN) and 

STLVAMC managers. The Veterans Health Administration (VHA) self-identified the 

deficiencies and took actions to correct them; however, those actions did not always 

resolve the issues. Responsible managers did not verify the adequacy of RME 

reprocessing practices, nor did they assure that corrective actions were consistently 

implemented in response to VHA guidance and the Infectious Disease Program Office 

(IDPO) report. As a result, standard operating procedures (SOPs) were not developed in 

a timely manner for the reprocessing of dental RME, SOPs did not always match 

manufacturers’ instructions, and Dental Clinic staff had not received training on dental 

RME pre-treatment or reprocessing. 

We concluded that the occurrence of a patient-to-patient transmission of a blood-borne 

infectious disease at the JCD was unlikely. Nevertheless, the Clinical Risk Board 

adhered to the process outlined in VHA Directive 2008-002 when it recommended 

disclosure to 1,812 patients potentially affected by breaches in the cleaning and 

sterilization processes. We concluded that the STLVAMC promptly set-up and staffed 

its Dental Review Clinic, made appropriate efforts to contact identified patients, and 

provided adequate support and follow-up to patients. 

We recommended that the VISN Director require the STLVAMC Director to monitor the 

facility’s compliance with all appropriate elements of RME reprocessing, SOPs, staff 

training, and staff competencies as defined in relevant VHA guidance; ensure that the 

VISN Supply, Processing, and Distribution Management Board provides monitoring to 

ensure that SOPs based on manufacturer’s instructions are in place and that staff training 

and competencies are current; and take appropriate administrative actions based on the 

findings of the Administrative Board of Investigation and IDPO report. 

VA Office of Inspector General i
DEPARTMENT OF VETERANS AFFAIRS
	

Office of Inspector General
	

Washington, DC 20420
	

TO: Director, VA Heartland Network (10N15) 

SUBJECT: Healthcare Inspection—Reprocessing of 

Cochran Division of the St. Louis VA 

Missouri 

Dental 

Medical 

Instruments, 

Center, St. Louis, 

John 

Purpose 

The VA Office of Inspector General Office (OIG) of Healthcare Inspections (OHI) 

received a request from Congressman Bob Filner, the then Chairman of the House 

Committee on Veterans’ Affairs, Congressman Jeff Miller, current Chairman of the 

House Committee on Veterans’ Affairs, and seven other members of Congress, calling 

for an inspection into reports that veterans in several states including Missouri could have 

been exposed to blood borne pathogens such as hepatitis B (HBV), hepatitis C (HCV), 

and human immunodeficiency virus (HIV) while receiving dental care at the John 

Cochran Division (JCD) of the St. Louis VA Medical Center (STLVAMC), St Louis, 

MO. The same letter also noted that a JCD employee allegedly raised concerns and 

warned management of unsanitary cleaning practices of dental instruments, and 2 months 

later, was retaliated against and fired for unprofessional conduct. 

The purpose of this review was to determine the sequence of events involving alleged 

improperly cleaned and sterilized dental reusable medical equipment (RME); errors in 

reprocessing or sterilization; actions taken to correct deficiencies; and decisions related to 

patient notification of breaches in dental equipment reprocessing or sterilization at 

STLVAMC. 

Background 

The STLVAMC is a two-division tertiary care facility in Veterans Integrated Service 

Network (VISN) 15. The JCD of the STLVAMC is located in downtown St. Louis. It 

has 136 acute care beds and provides acute medical and surgical services as well as a 

wide range of specialty care. The Jefferson Barracks Division of the STLVAMC is 

located in south St. Louis County. This Division provides primary care and has 

102 acute beds, 50 domiciliary beds, and 71 community living center beds. 

VA Office of Inspector General 1
Reprocessing of Dental Instruments, John Cochran Division of the St. Louis VAMC, St. Louis, Missouri

The STLVAMC Dental Service workload and procedure codes indicate that the Service 

performs a full spectrum of dental and surgical procedures. In fiscal year 2009, it had 

6 dentists and oral surgeons, 2 dental hygienists, and 11 dental assistants and dental lab 

technicians. Workload equaled 6,283 patient encounters. The Chief of Dental Service 

reports to the STLVAMC’s Associate Chief of Staff for Primary Care. 

In recent years, several Veterans Health Administration (VHA) medical facilities were 

found to deviate from recommended procedures for the reprocessing (cleaning and 

sterilization) of RME, resulting in patient recalls and/or temporary suspension of 

procedures. These events prompted Congress to ask OHI to conduct a national review, 

and on June 16, 2009, we reported that several VHA medical facilities had not complied 

with management directives to ensure compliance with reprocessing of endoscopes. We 

noted that, “Reprocessing of endoscopes requires a standardized, monitored approach to 

ensure that these instruments are safe for use in patient care.”1 We found apparent 

improvement in reprocessing operations during a follow-up review 3 months later.2 

Over the past 2 years, VHA has published new guidance on RME reprocessing; directed 

numerous field-level activities such as an intensive “deep-dive” exercise in March 2009;3 

realigned Supply, Processing, and Distribution (SPD) under the Nursing Service; 

mandated annual VISN-level site visits that review RME issues; and instituted numerous 

quality control and improvement processes that address RME reprocessing. 

In spite of these efforts, some VHA medical facilities have not sustained the 

improvements recognized in September 2009 and are not consistently complying with all 

requirements. The STLVAMC was cited in an April 2010 OHI report regarding 

reprocessing of endoscopes.4 We reviewed selected aspects of RME reprocessing during 

OIG Combined Assessment Program reviews conducted in calendar year 2010 and found 

endoscope-related reprocessing deficiencies in several of the facilities visited. We cited 

five VHA medical facilities specifically for non-compliance with dental RME 

reprocessing guidelines. The aggregated results of that review will be published under 

separate cover. 

Dental RME 

Because the mouth is highly vascular, routine dental procedures such as fillings, 

extractions, dentures, bridges, and gum care may be associated with bleeding. Even 

1 Healthcare Inspection—Use and Reprocessing of Flexible Fiberoptic Endoscopes at VA Medical Facilities, June
 

16, 2009, Report Number 09-01784-146.

2 Healthcare Inspection—Follow-Up Colonoscope Reprocessing at VA Medical Facilities, September 17, 2009,
 

Report Number 09-02848-218.

3 On February 4, 2009, VHA announced an “Endoscopy Step Up Week” for March 8-14. This activity, frequently
 

referred to as the RME “deep-dive” exercise, focused on the intensive review of set-up and reprocessing procedures
 

for all endoscopes, tubing, and other accessories throughout VHA medical facilities.

4 Alleged Endoscope Reprocessing Issues St. Louis VA Medical Center, St. Louis, Missouri, April 21, 2010, Report
 

No. 10-01141-133.
 

VA Office of Inspector General 2
Reprocessing of Dental Instruments, John Cochran Division of the St. Louis VAMC, St. Louis, Missouri

without bleeding, the oral cavity is lined by a mucosal surface that presents only a thin 

protective barrier to outside agents. If instruments or equipment are used with multiple 

patients, there must be proper cleaning, sterilization, and other preparations between 

patient uses. 

RME refers to items which are manufactured for reuse or for which the manufacturer has 

provided specific written re-sterilization instructions. Dental RME includes “dental 

hand-pieces,” referring to the high-speed dental drills used to remove tooth material prior 

to filling, and dental instruments such as stainless steel dental mirrors, probes, and 

retractors. 

Reprocessing is the term used to encompass cleaning, disinfection, sterilization, and 

preparation of equipment to full readiness for use. VA Handbook 7176, Supply, 

Processing, and Distribution (SPD) Operational Requirements, states that RME should 

be reprocessed in the SPD decontamination area. If decontamination occurs in other 

areas of a medical center, all procedures listed in the handbook will apply to that area. 

For a time, dental RME was reprocessed in the Dental Clinic. 

An important infection control practice to prevent RME cross-contamination is the 

removal of all visible debris as soon after use as possible. Manufacturers of dental 

instruments publish detailed instructions on how to clean and sterilize these items. While 

instructions may differ slightly, the general procedures involve: 

1. Wiping instruments down with an appropriate cloth immediately after use 

2.	 Pre-treating instruments with enzymatic foams or gels to keep residual blood and 

debris moist during transport 

3. Cleaning instruments with specified detergents	 and a nylon brush to remove 

bioburden and debris, or using an ultrasonic machine 

4. Thorough rinsing 

5. Thorough drying with a lint-free cloth 

6. Packaging of dried instruments for sterilization 

7. Sterilization according to manufacturer’s instructions 

Steps 1–2 are considered pre-treatment activities. Step 1 should occur in the treatment 

area and Step 2 should occur in a designated processing area in or near the Dental Clinic. 

If items are to be transported to the medical center’s SPD area for Steps 3–7, then Dental 

Clinic staff should “package” items for transport using cassettes or utility bins. Prior to a 

July 1, 2010, memorandum from VHA’s Deputy Undersecretary for Health for 

Operations and Management (DUSHOM) to the VISN Directors, Steps 3–6 may occur in 

either the Dental Clinic or the SPD decontamination area. Step 7 has always been 

delegated to SPD. 

VA Office of Inspector General 3
Reprocessing of Dental Instruments, John Cochran Division of the St. Louis VAMC, St. Louis, Missouri

Dental Instrument-related Infection 

Infections may be transmitted through dental procedures by several routes, including 

transmission of infection from patient to dental health care worker (DHCW), from 

DHCW to patient, from patient-to-patient, and secondary transmission to an individual 

outside of the health care setting such as from patient or DHCW to a family member. 

Direct transmission of infection from patient to DHCW, and from DHCW to patient, are 

the most prevalent. However, indirect transmission of blood-borne infection from 

patient-to-patient is an uncommon, but real, risk. A 2010 article in the Journal of Viral 

Hepatitis notes, “HBV transmission can occur in dentistry if there is any lapse in 

sterilization procedures or if there is transmission of infected body fluids to patients.”5 

Disclosure of Adverse Events 

VHA Directive 2008-002 provides guidance for disclosure of adverse events related to 

clinical care to patients or to their personal representatives.6 The directive includes 

instances “where the adverse event may not be obvious or severe, or where the harm may 

only be evident in the future.” It was developed based on VHA’s National Center for 

Ethics in Health Care report “Ethical Leadership: Fostering an Ethical Environment and 

Culture,”7 which notes: 

Within the Veterans Health Administration, there is a presumptive 

obligation to disclose adverse events that cause harm to patients. However, 

in the case of an adverse event that has the potential to affect dozens or 

even thousands of patients, a public health response also requires a 

determination of the probability and magnitude of harm resulting from the 

adverse event as well as a weighing of additional factors, including, but not 

limited to salient ethical principles; risk of harm to veterans and identifiable 

third parties; benefit and burden of disclosure to veterans including 

medical, psychological, social or economic, impact on the institution's 

perceived integrity and its capacity to provide care and treatment for all 

veterans; as well as applicable policy and relevant precedent.8 

Adverse events are defined as “untoward incidents, therapeutic misadventures, iatrogenic 

injuries, or other adverse occurrences directly associated with care or services provided 

within the jurisdiction of a medical center, outpatient clinic, or other VHA facility.” 

5 Mahboobi N., et al., “Hepatitis B virus infection in dentistry: a forgotten topic.”J Vir Hep, 17, 307-316 (2010)
 6 VHA Directive 2008-002, Disclosure of Adverse Events to Patients, January 18, 2008.
 7 2007, p. 34.
 8 National Center for Ethics Report on Ethical Leadership: Fostering an Ethical Environment and Culture, 2007
 

VA Office of Inspector General 4
Reprocessing of Dental Instruments, John Cochran Division of the St. Louis VAMC, St. Louis, Missouri

VHA Directive 2008-002 defines large scale disclosure of adverse events as “involving a 

large number of patients, even if at a single facility.”9 Authority and responsibility for 

large scale disclosures resides with VHA’s Principal Deputy Under Secretary for Health 

(PDUSH). Often the issues will be clear and the PDUSH will proceed according to the 

facts and available medical science. However, if the issues are unclear, the PDUSH can 

request that the DUSHOM convene the Clinical Risk Board (CRB),10 an ad-hoc 

consultative board. 

CRB members include representatives from the Office of the DUSHOM, Office of the 

National Center for Ethics in Health Care, Office of Quality and Performance, National 

Center for Patient Safety, Office of Patient Care Services, and Office of Public Health 

and Environmental Hazards (OPHEH). Additionally, individuals knowledgeable about 

the case at hand, subject matter experts, and stakeholders affected by the decision may be 

asked to participate. 

Key issues that the CRB is expected to address include the number of veterans exposed 

or potentially exposed; the probability that the adverse event will cause harm; the nature, 

magnitude, and duration of the potential harm; and the availability of treatment to prevent 

or ameliorate harm. To estimate the number of veterans potentially exposed, the CRB 

must consider the risk period when conditions were non-compliant or deficient. The risk 

period dates are referred to as “lookback” dates in the remainder of this report. 

VHA Directive 2008-002 recognizes that although it is difficult to weigh all benefits and 

harms, situations prompting a decision whether to conduct large-scale disclosure of 

adverse events likely involve the following considerations: 

	 Are there medical, social, psychological, or economic benefits or burdens to the 

veterans, resulting from the disclosure itself? 

	 What is the burden of disclosure to the institution, focusing principally on the 

institution's capacity to provide health care to other veterans? 

	 What is the potential harm to the institution of both disclosure and non-disclosure 

in the level of trust that veterans and Congress would have in VHA? 

The CRB may choose to recommend notification if “one patient or more in 

10,000 patients subject to the event or exposure is expected to have a short-term or longterm health effect that would require treatment or cause serious illness if untreated.” 

9 Attachment A of VHA Directive 2008-002 recognizes that adverse events with a known risk of serious future
 

health consequences may be associated with an “extremely small” risk.

10 The CRB was formerly known as the Clinical Risk Assessment Advisory Board (CRAAB).
 

VA Office of Inspector General 5
Reprocessing of Dental Instruments, John Cochran Division of the St. Louis VAMC, St. Louis, Missouri

STLVAMC Dental Clinic Problems 

From March 9–12, 2010, VHA’s National Infectious Diseases Program Office (IDPO) 

conducted a routine, facility-wide inspection of both STLVAMC Divisions. The purpose 

of this facility-wide inspection was “to evaluate the performance of the SPD operations 

and related areas performing decontamination, sterilization, high-level disinfection and 

storage of clean/sterile medical and surgical items.” 

The IDPO team inspected multiple areas of the JCD where RME reprocessing occurs and 

found that Dental Clinic employees were not always cleaning dental instruments 

according to manufacturers’ instructions. 

The IDPO team identified 21 unacceptable infection control-related conditions or 

practices in the JCD Dental Clinic. These problems included: 

	 Soiled items were observed being packaged and heat-sealed for sterilization 

without proper cleaning. 

	 Items were visibly dirty post-sterilization. 

	 Items sealed for sterilization were visibly wet. 

	 A basin was observed to be incorrectly wrapped prior to sterilization. 

	 Items were being packaged for the incorrect sterilization method. 

	 Standard operating procedures (SOPs), manufacturers’ instructions, and staff 

competencies were not available for review. 

	 Staff was not familiar with relevant VHA guidance regarding RME. 

STLVAMC managers closed the JCD Dental Clinic on March 12 pending completion of 

an investigation into the issues. The same day, STLVAMC’s senior management 

provided an “Issue Brief” to the VISN which delineated a variety of corrective actions 

being taken or planned, including SOP updates, staff training, environmental inspections, 

and re-sterilization of all affected dental instruments. 

Between March 12 and April 20, STLVAMC corrective actions included sterilizing all 

instruments removed from the Dental Clinic, training staff on the content of all VHA 

Handbooks and Directives related to RME, and initiation of infection control training. 

On March 18, the Oral Surgery and Dental Hygiene Clinics reopened and on March 26, 

General Dentistry reopened. STLVAMC’s Chief, Infectious Diseases Service reviewed 

laboratory tests for patients seen in the Dental Clinic between February 1, 2009, and 

March 11, 2010, and provided the results to STLVAMC leaders. 

On April 21, members of VHA’s CRB convened a preliminary meeting with 

STLVAMC’s leadership, Dental Service and Processing and Decontamination (P&D) 

managers, IDPO staff, and the facility’s Infectious Diseases Service Chief. This preVA Office of Inspector General 6
Reprocessing of Dental Instruments, John Cochran Division of the St. Louis VAMC, St. Louis, Missouri

CRB meeting was a basic fact-finding exercise to determine whether the reprocessing 

breaches appeared to meet criteria for disclosure to potentially affected patients. If so, a 

formal CRB would be convened. The IDPO’s position was that the risk to patients was 

“low but was not negligible or non-existent,” and the pre-CRB attendees unanimously 

agreed. 

According to the April 21 pre-CRB minutes, a facility quality manager visited the Dental 

Clinic as part of the deep-dive exercise sometime in the first week of February 2009. The 

quality manager observed a JCD Dental Clinic employee complete the necessary steps to 

place a dental cassette into a dirty bin for transport to P&D. This was the most recent 

acceptable assessment of reprocessing procedures in the Dental Clinic. 

The DUSHOM formally chartered the CRB on April 26, and on May 6, the CRB met to 

review the IDPO site visit findings and other relevant facts. The CRB noted that: 

	 Dental instruments with visible bioburden (tissue, blood) were packaged for 

sterilization. 

	 Visibly wet instruments were packaged for sterilization. 

	 Different colored peel-packs were used to denote the type of sterilization needed. 

Dental RME requires steam sterilization; however, dental instruments were, at 

times, sealed in peel-packs for gas sterilization. 

The equipment manufacturer would not verify the sterility of instruments that were not 

sterilized according to manufacturer’s instructions. As such, the CRB concluded that 

“under these circumstances, the risk for blood borne pathogens, although low, was not 

negligible.” 

In selecting the lookback dates, the CRB considered the STLVAMC Acting Medical 

Center Director’s statement, as noted in the April 21 pre-CRB minutes, that P&D 

workload had increased in 2009 due to a higher volume of endoscopies and surgeries. 

P&D staff were overwhelmed, and in an effort to “help,” Dental Clinic staff began 

cleaning and packaging instruments for sterilization sometime after February 2009. The 

STLVAMC Infectious Diseases Service Chief’s statement, which was also noted in the 

April 21 pre-CRB minutes, indicated that February 1, 2009, was the last time the Dental 

Clinic processes were deemed adequate. It was the quality manager’s observation of 

correct practices in February 2009 that was the basis for the selection of that time as the 

outer limit of the lookback period. 

On May 7, the CRB formally recommended disclosure to patients possibly affected by 

dental RME sterilization lapses occurring from February 1, 2009, to March 12, 2010. 

The CRB further recommended that each patient be offered serologic testing for HBV, 

HCV, and HIV, according to a protocol developed by the OPHEH. Disclosure letters 

were sent to the affected patients on or about June 28. 

VA Office of Inspector General 7
Reprocessing of Dental Instruments, John Cochran Division of the St. Louis VAMC, St. Louis, Missouri

In a July 1, 2010, memorandum, the DUSHOM directed all VHA facilities to discontinue 

dental instrument pre-cleaning and sterilization outside of SPD. This change was to be 

completed by July 9 and VISNs were to confirm implementation. On July 23, the 

DUSHOM issued additional guidance clarifying that pre-treatment (wiping and using 

enzymatic foams) could continue to occur in the Dental Clinic. The 

July 23 memorandum reiterated that reprocessing activities (cleaning, decontamination, 

wrapping, and sterilization) shall only occur in SPD. 

On July 7, VHA’s DUSHOM called for an Administrative Board of Investigation (ABI) 

to “investigate any and all circumstances surrounding the alleged failure of the St. Louis 

VAMC to detect deficiencies in the pre-cleaning of dental instruments.” 

Scope and Methodology 

We visited the JCD of the STLVAMC from August 31–September 2 and 

September 27–30, 2010. We interviewed relevant clinical and administrative staff, 

including STLVAMC’s Acting Director; Quality Manager; both the former and Acting 

Chiefs of the Dental Service; Chief, P&D; Chief, Infectious Diseases Service; and 

infection control nurses. We also interviewed the CRB Chairperson, medical consultants 

from the Prevention and Response Branch of the Center for Disease Control, and OPHEH 

staff. 

We reviewed the ABI and its testimony; VHA Directives 2009-004, 2009-031, and 

2008-002; and VA Handbook 7176, Supply, Processing, and Distribution (SPD) 

Operational Requirements, August 16, 2002. We reviewed VISN Issue Briefs; the IDPO 

report; CRB charters, memoranda, and related minutes; relevant medical literature; 

facility-level SOPs and manufacturer instructions for cleaning and sterilization of 

equipment; incident reports; Dental and P&D Service training records and competencies; 

documents related to the Dental Review Clinic (DRC);11 and corrective action plans. 

The issue of alleged whistleblower retaliation is not addressed herein as the Office of 

Special Counsel (OSC), an independent federal investigative and prosecutorial agency 

charged with evaluating alleged reprisal for whistleblower disclosure, has jurisdiction in 

these matters.12,13 

We performed the inspection in accordance with Quality Standards for Inspections 

published by the Council of the Inspectors General on Integrity and Efficiency. 

11 The “Dental Review Clinic” (DRC) was implemented to notify patients about the possible exposure and testing 

instructions. It included a location for patients to obtain information, receive counseling, and undergo testing related 

to the possible exposure. It also included a call center for appointment scheduling as well as address patient 

concerns related to the possible exposures.

12 http://www.osc.gov/wbdiscOverview.htm, accessed November, 20, 2010 

13 5 U.S.C. Section (§) 1213 

VA Office of Inspector General 8
Reprocessing of Dental Instruments, John Cochran Division of the St. Louis VAMC, St. Louis, Missouri

Inspection Results 

Issue 1. Inconsistent Pre-treatment and Cleaning of Dental RME 

We found inconsistency in the performance of instrument pre-treatment (Steps 1–2) prior 

to cleaning. Because Dental Clinic staff did not document their activities, we could not 

confirm whether enzymatic foams were consistently used. 

We found inconsistency in the performance of cleaning instruments (Steps 3–6). 

Because Dental Clinic staff did not document their reprocessing activities, we could not 

confirm that the appropriate detergents were used, that instruments were brushed to 

remove bioburden, or that the ultrasonic machine contained the correct concentration of 

detergent to ensure adequate pre-cleaning. 

Issue 2. Problematic and Absent SOPs 

SOPs were not developed in a timely manner for the reprocessing of dental RME, and the 

SOPs did not always match the manufacturers’ instructions as required by Directive 

2009-004. We found that dental RME SOPs were generally not published until July and 

September 2010, a year after the Directive was issued. Of the dental instrumentation 

used at the STLVAMC that we reviewed, the majority still did not have a corresponding 

published SOP at the time of our September 27–30, site visit. Additionally, we found 

discrepancies between the SOPs and the manufacturers’ instructions in all five cases 

where manufacturers’ instructions were available. 

We also found that SOPs were not posted or otherwise readily available to staff with 

responsibility for pre-treatment and reprocessing of dental RME, either in the Dental 

Clinic or in P&D. 

Issue 3. Inadequate Staff Training and Competencies 

Managers were not able to produce documentation to support staff training on dental 

RME pretreatment or reprocessing. Directive 2009-004 requires staff to be trained on the 

reprocessing of RME prior to initial use. However, staff reported that they did not 

receive dental RME training; rather, they followed procedures they learned in school, 

practiced in previous private-sector jobs, or observed others doing. 

Directive 2009-004 defines competence as “the assurance that an individual has received 

the appropriate training and has demonstrated an achieved skill level required to 

independently and appropriately perform an assigned reprocessing task or responsibility” 

and calls for “documented” initial and continued staff competence at least annually. 

Neither P&D nor Dental Clinic staff had current documented competencies for the 

12 pieces of dental instrumentation used at the STLVAMC. 

VA Office of Inspector General 9
Reprocessing of Dental Instruments, John Cochran Division of the St. Louis VAMC, St. Louis, Missouri

We noted that multiple managers referred to a procedural change in early February 2009 

when Dental Clinic employees began to “help” P&D by assuming responsibility for pretreatment, but also cleaning of instruments using detergents and brushes. We found no 

evidence that responsible managers took action to assure that Dental Clinic staff received 

training on these “new” responsibilities or verified staff competencies to perform these 

added duties. 

Issue 4. Inadequate Oversight of SPD Functions 

As noted, there were ongoing deficiencies related to dental RME reprocessing, SOPs, and 

staff training and competencies. 

We also found that the VISN 15 SPD Management Board did not provide the necessary 

level of oversight as required by VHA Directive 2009-031. VISN 15 chartered a Board 

to provide “oversight of all reprocessing of RME occurring within the VISN. The Board 

has the accountability and authority for ensuring reprocessing (and other SPD functions) 

occurs to exacting standards.” We reviewed meeting minutes for September 14, 2009, 

through July 26, 2010, and found that the Board held quarterly meetings to discuss 

implementation of a facility SPD query review tool and quality assurance report and also 

addressed plans for unannounced facility SPD site visits. However, we did not find 

evidence that the Board monitored that SOPs based on manufacturer’s instructions were 

in place and that the staff training and competencies were current. 

Issue 5. Well-structured Patient Notification Processes 

We found that VHA acted promptly to evaluate the nature of the apparent exposure, 

determine the potential rate of infection, and make recommendations for disclosure. The 

CRB recommended disclosure on May 7, about 8 weeks after identification of the dental 

RME problems. The STLVAMC then created and staffed its DRC and Call Center for 

potentially affected patients to schedule blood tests and receive counseling, if desired. 

Patient notification letters were sent around June 28. Overall, the STLVAMC’s recall 

effort was well-structured and organized, and staff appropriately followed up with 

potentially affected patients. 

When the lookback period came under scrutiny in late August due to preliminary OHI 

findings that the February 2009 demarcation may not have been accurate, VHA’s 

PDUSH re-chartered the CRB on September 14 to reassess the dates (and the possible 

need to expand the pool of notified patients.) On October 8, the CRB made the following 

recommendations: 

Based on our deliberations at the September 16th, 2010 CRB meeting and 

the responses to our questions, the CRB unanimously recommends that the 

current lookback for the period February 2009 to March 2010 should be 

completed and the testing results analyzed. If clustering (or grouping) of 

cases of blood borne viral infections are documented (indicating patient to 

VA Office of Inspector General 10
Reprocessing of Dental Instruments, John Cochran Division of the St. Louis VAMC, St. Louis, Missouri

patient transmission of viral disease within the Dental Clinic), then the 

CRB should be re-convened to recommend if further look back is required 

prior to February 2009. The Office of Public Health and Environmental 

Hazards will propose a definition for clustering of cases. 

The CRB concluded that a total of 1,812 patients were potentially affected by the dental 

instrument cleaning and sterilization issues. Forty-three patients were since deceased, 

and thus, disclosure notices were sent to 1,769 patients (1,812–43). Of these 

1,769 patients to whom disclosure was attempted, 1,763 made contact with or otherwise 

were contacted by the STLVAMC. There were 105 patients who refused testing. 

OPHEH informed us that as of November 16, 2010, four patients who had either not been 

tested before or had previously tested negative, now tested positive—two were newly 

diagnosed with HBV, and two with HCV. However, the OPHEH did not find evidence 

of clustering, and concluded that additional disclosures were not indicated. 

We found that this case caused the CRB role and processes to undergo re-evaluation. We 

were informed that the release of a new VHA handbook that further delineates the CRB 

roles and processes and will serve to replace VHA Directive 2008-002 is pending. 

Conclusions 

The dental RME reprocessing issues at the JCD were a long-standing problem that went 

unrecognized and unaddressed by VISN and STLVAMC managers. In this instance, 

VHA self-identified the deficiencies and took actions to correct them; however, some 

conditions still existed at the time of our site visits. 

Responsible managers did not verify the adequacy of RME reprocessing practices nor did 

they assure that corrective actions were consistently implemented in response to VHA 

guidance and the IDPO report. As a result, SOPs were not developed in a timely manner 

for the reprocessing of dental RME, SOPs did not always match manufacturers’ 

instructions, and Dental Clinic staff had not received training and did not have 

documented competencies on dental RME pre-treatment or reprocessing. 

We concluded that the occurrence of a patient-to-patient transmission of a blood-borne 

infectious disease at the JCD was unlikely. Nevertheless, the CRB adhered to the process 

outlined in VHA Directive 2008-002 when it recommended disclosure to 1,812 patients 

potentially affected by breaches in the cleaning and sterilization processes. We 

concluded that the STLVAMC promptly set-up and staffed its DRC, made appropriate 

efforts to contact identified patients, and provided adequate support and follow-up to 

patients. 

VA Office of Inspector General 11
Reprocessing of Dental Instruments, John Cochran Division of the St. Louis VAMC, St. Louis, Missouri

Recommendations 

Recommendation 1. We recommended that the VISN Director requires the STLVAMC 

Director to monitor the facility’s compliance with all appropriate elements of RME 

reprocessing, SOPs, staff training, and staff competencies as defined in relevant VHA 

guidance. 

Recommendation 2. We recommended that the VISN Director ensure that the VISN 

SPD Management Board performs monitoring to ensure that SOPs are in place and that 

staff training and competencies are current. 

Recommendation 3. We recommended that the VISN Director take appropriate 

administrative actions based on the findings of the ABI and IDPO report. 

Comments 

The VISN and Medical Center Directors agreed with the findings and recommendations 

(see Appendixes A and B, pages 13–16, for the Directors’ comments). The 

implementation plans are acceptable, and we will follow up on the planned actions until 

they are completed. 

 (original signed by:)

JOHN D. DAIGH, JR., M.D.
 

Assistant Inspector General for
 

Healthcare Inspections
 

VA Office of Inspector General 12
Reprocessing of Dental Instruments, John Cochran Division of the St. Louis VAMC, St. Louis, Missouri

Appendix A 

VISN Director Comments
	

Department of 

Veterans Affairs Memorandum 

Date: February 15, 2011
 

From: Director, VA Heartland Network (10N15)
 

Subject: Healthcare Inspection – Reprocessing of Dental Instruments,
 

John Cochran Division of the STLVAMC, St. Louis, Missouri 

To: Director, Atlanta Office of Healthcare Inspections (54AT) 

Thru: Director, Management Review Service (10B5) 

I have reviewed the recommendations and concur with the St. Louis 

Medical Center’s response and action plans. If you have any 

questions, please contact VISN office at (816)-701-3000. 

(original signed by:) 

JAMES R. FLOYD, FACHE 

VA Office of Inspector General 13
Reprocessing of Dental Instruments, John Cochran Division of the St. Louis VAMC, St. Louis, Missouri

Appendix B 

Medical Center Director Comments
	

Department of 

Veterans Affairs Memorandum 

Date: February 15, 2011
 

From: Director, St. Louis VA Medical Center, John Cochran Division (657/00)
 

Subject:	 Healthcare Inspection – Reprocessing of Dental Instruments, 

John Cochran Division of the STLVAMC, St. Louis, Missouri 

To:	 Director, VA Heartland Network (10N15) 

1. Our comments and action plans have been entered directly 

into this report as requested. 

2. Should you need additional information, please contact 

Patricia Hendrickson, RN, MSN, CPHQ, Director of Quality 

Management at (314)-289-7020. 

(original signed by:) 

RIMAANN O. NELSON, RN, MPH/HSA
 

St Louis VA Medical Center Director
 

VA Office of Inspector General 14
Reprocessing of Dental Instruments, John Cochran Division of the St. Louis VAMC, St. Louis, Missouri

Director’s Comments
	

to Office of Inspector General’s Report
	

The following Director’s comments are submitted in response to the 

recommendations in the Office of Inspector General’s report: 

OIG Recommendations 

Recommendation 1. We recommended that the VISN Director requires 

the STLVAMC Director to monitor the facility’s compliance with all 

appropriate elements of RME reprocessing, SOPs, staff training, and staff 

competencies as defined in relevant VHA guidance. 

Concur Target Completion Date: February 28, 2011 

STLVAMC Director will continue to monitor compliance with all 

appropriate elements of RME processing. The STLVAMC RME 

Committee, co-chaired by Associate Director Patient and Nursing Service 

and Deputy Chief of Staff will enhance oversight by reviewing, monitoring, 

and implementing of all necessary action plans to maintain compliance with 

relevant VHA RME guidance through standing agenda items in the RME 

Committee. These agenda items include: 1) Staff Competencies, 

2) Standard Operating Procedures, 3) Staff Education and Training, 

4) Workload Level Evaluation, 5) Quality Indicators such as Early 

Releases, Environmental Monitoring, and Biological Testing. 

STLVAMC will complete a minimum of six self inspections using 

standardized review tools with a multi-disciplinary team including nursing 

leadership, chief P&D, infection prevention, patient safety, quality 

management, two members of the RME committee, and area staff. Action 

plans will be developed, reported, and tracked in STLVAMC RME 

Committee and VISN SPD Management Board. 

The RME meeting minutes, containing the oversight information from 

items 1–5 listed above, will be reviewed by the Executive Management 

Team on a monthly basis in the Executive Committee Meeting chaired by 

the Medical Center Director. 

VA Office of Inspector General 15
Recommendation 2. We recommended that the VISN Director ensure that 

the VISN SPD Management Board monitors to ensure that SOPs are in 

place and that staff training and competencies are current. 

Concur Target Completion Date: March 28, 2011 

The VISN SPD Board is using the tool developed by Central Office in 

FY11 for the VISN oversight reviews. This tool provides detailed 

information on SOPs, competency completion and training documentation. 

The VISN SPD Board is also adding two sections to its SPD query tool. 

Those two sections are: 

1. The Medical Center process for maintaining SOPs. 

2. The Medical Center processes for maintaining competencies. 

In addition, SOPs, competencies and training are being added as a standing 

agenda item to each Board meeting. 

Recommendation 3. We recommended that the VISN Director take 

appropriate administrative actions based on the findings of the ABI and 

IDPO report. 

Concur Target Completion Date: January 24, 2011 

The VISN Director and STLVAMC Directors have taken the recommended 

administrative actions based on the findings of the ABI and IDPO report. 

VA Office of Inspector General 16
Reprocessing of Dental Instruments, John Cochran Division of the St. Louis VAMC, St. Louis, Missouri

Appendix C 

OIG Contact and Staff Acknowledgments
	

OIG Contact	 George Wesley, MD 

Office of Healthcare Inspections 

Acknowledgments	 Toni Woodard, Team Leader 

Victoria Coates 

Kathleen Shimoda 

VA Office of Inspector General 17
Reprocessing of Dental Instruments, John Cochran Division of the St. Louis VAMC, St. Louis, Missouri

Appendix D 

Report Distribution
	

VA Distribution 

Office of the Secretary 

Veterans Health Administration 

Assistant Secretaries 

General Counsel 

Director, VA Heartland Network (10N15) 

Director, St. Louis VA Medical Center, John Cochran Division (657/00) 

Non-VA Distribution 

House Committee on Veterans’ Affairs 

House Appropriations Subcommittee on Military Construction, Veterans Affairs, and 

Related Agencies 

House Committee on Oversight and Government Reform 

Senate Committee on Veterans’ Affairs 

Senate Appropriations Subcommittee on Military Construction, Veterans Affairs, and 

Related Agencies 

Senate Committee on Homeland Security and Governmental Affairs 

National Veterans Service Organizations 

Government Accountability Office 

Office of Management and Budget 

U. S. Senate: Roy Blunt, Claire McCaskill 

U.S. House of Representatives: Todd Akin, Russ Carnahan, William Lacy Clay, Jr. 

This report is available at http://www.va.gov/oig/publications/reports-list.asp. 

VA Office of Inspector General 18