Department of Veterans Affairs 

Office of Inspector General 

Healthcare Inspection 

Use and Reprocessing of Flexible 

Fiberoptic Endoscopes at 

VA Medical Facilities 

Report No. 09-01784-146 June 16, 2009
 

VA Office of Inspector General 

Washington, DC 20420 
 

 

 

To Report Suspected Wrongdoing in VA Programs and Operations 

Telephone: 1-800-488-8244 between 8:30AM and 4PM Eastern Time,

 Monday through Friday, excluding Federal holidays

 E-Mail: vaoighotline@va.gov 
Use and Reprocessing of Flexible Fiberoptic Endoscopes at VA Medical Facilities 

Contents 

Page 

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

Introduction ..........................................................................................................1 

Purpose........................................................................................................................... 1
 

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

Endoscopy ................................................................................................................. 1 

Reprocessing of Reusable Medical Equipment......................................................... 2 

Endoscopy-Related Infection .................................................................................... 3 

Endoscopy in VHA.................................................................................................... 4 

Disclosure and the Clinical Risk Assessment Advisory Board................................. 5 

Section I – Recent Events involving Endoscope Use and Reprocessing ......9 

Scope and Methodology ................................................................................................ 9
 

Findings.......................................................................................................................... 9 

A. Colonoscopy .......................................................................................................... 9 

Tennessee Valley Healthcare System – Alvin C. York (Murfreesboro) Campus... 9 

National Center for Patient Safety Alert and Subsequently Reported Problems .. 12 

CRAAB Response to Murfreesboro Event ........................................................... 12 

CRAAB Response to 16 Facilities Reporting Problems After NCPS Alert ......... 13 

Step-Up Week........................................................................................................ 14 

Bruce W. Carter VA Medical Center, Miami, Florida.......................................... 15 

B. ENT Endoscopy................................................................................................... 17 

Charlie Norwood VA Medical Center, Augusta, Georgia .................................... 17 

Section II – National Assessment of Reprocessing Practices in VHA..........18 

Scope and Methodology .............................................................................................. 18
 

Study Populations...................................................................................................... 18 

Sample Design........................................................................................................... 19 

Site Visits for Document Examination...................................................................... 20 

Presence of Endoscope Reprocessing SOPs ............................................................. 21 

VA Office of Inspector General 
Use and Reprocessing of Flexible Fiberoptic Endoscopes at VA Medical Facilities 

Presence of Endoscope Reprocessing Competence Records .................................... 21 

Statistical Analysis .................................................................................................... 21 

Findings........................................................................................................................ 24 

A. Responsibility for Reprocessing Endoscopes in VHA, Based on Facility 

Self-Reported Information Findings.......................................................................... 26 

B. Compliance with VHA Directive 2009-004 Based on Unannounced 

Onsite Inspection ....................................................................................................... 28 

Issue 1. Absence of Colonoscope Model-Specific Reprocessing SOPs 

Issue 2. Absence of ENT Endoscope Model-Specific Reprocessing SOPs 

Appendixes
 

and/or Competence Records.................................................................................. 28 

and/or Competence Records.................................................................................. 29 

Issue 3. Compliance and Responsibility for Reprocessing Endoscopes .............. 30 

Conclusions and Recommendations ...............................................................32 

A. CPT and ICD-9 Codes ........................................................................................... 33
 

B. National Center for Patient Safety Review of Reprocessing Issues ...................... 34
 

C. VA Facilities Sampled ........................................................................................... 39
 

D. Acting Under Secretary for Health Comments...................................................... 41
 

E. OIG Contact and Staff Acknowledgments............................................................. 44
 

F. Report Distribution ................................................................................................. 45
 

VA Office of Inspector General 
Use and Reprocessing of Flexible Fiberoptic Endoscopes at VA Medical Facilities 

Executive Summary 

Introduction 

The VA Office of Inspector General received requests from the Secretary, Chairmen and 

Ranking Members of VA oversight committees, along with individual members of 

Congress, regarding the reprocessing of endoscopic equipment at several specific VA 

medical centers (VAMCs), and to assess the extent of related problems throughout the 

Veterans Health Administration (VHA). The purpose of the review is to describe the 

pertinent events at VAMCs where problems were reported, assess VHA’s response to the 

events, and conduct a system-wide evaluation of current reprocessing practices. 

Results 

We visited the facilities which had been the subject of considerable media attention: the 

Bruce W. Carter VAMC (Miami) in Miami, FL; the Tennessee Valley Healthcare 

System-Murfreesboro campus (Murfreesboro); and the Charlie Norwood VA Medical 

Center (Augusta) in Augusta, GA. We reviewed applicable regulations, policies, 

procedures, and guidelines. Furthermore, 26 inspectors conducted unannounced onsite 

visits for the total of 42 probability-based randomly selected VHA facilities to examine 

pertinent endoscope reprocessing documentation. 

Because of the unannounced nature of the inspections and for cost-efficiency, a stratified 

clustering sample design was employed to maximize the number of facilities that could 

be inspected in a single day. Two probability-based random samples of VHA endoscope 

reprocessing facilities were selected from the study populations for the unannounced 

onsite inspection: one for colonoscope reprocessing and another for ENT endoscope 

reprocessing. With probability sampling, each unit in the study population has a known 

positive probability of selection. This property of probability sampling avoids selection 

bias and allows use of statistical theory to make valid inferences from the sample to the 

study population. 

Conclusions and Recommendations 

Facilities have not complied with management directives to ensure compliance with 

reprocessing of endoscopes, resulting in a risk of infectious disease to veterans. 

Reprocessing of endoscopes requires a standardized, monitored approach to ensure that 

these instruments are safe for use in patient care. 

The failure of medical facilities to comply on such a large scale with repeated alerts and 

directives suggests fundamental defects in organizational structure. 

VA Office of Inspector General i 
Use and Reprocessing of Flexible Fiberoptic Endoscopes at VA Medical Facilities 

The Clinical Risk Assessment Advisory Board has been an effective mechanism for 

providing guidance to VHA leadership on disclosure of adverse events to veterans. 

Recommendation 1: We recommended that the Acting Under Secretary for Health 

ensure compliance with relevant directives regarding endoscope reprocessing. 

Recommendation 2: We recommended that the Acting Under Secretary for Health 

explore possibilities for improving the reliability of endoscope reprocessing with VA and 

non-VA experts. 

Recommendation 3: We recommended that the Acting Under Secretary for Health 

review the VHA organizational structure and make the necessary changes to implement 

quality controls and ensure compliance with directives. 

Comments 

The Acting Under Secretary for Health concurred with the findings and 

recommendations. See Appendix D (pages 41–43) for the full text of his comments. He 

stated his commitment to resolve the urgent management and clinical issues involved. 

VHA will provide its detailed plan of corrective action in July 2009. 

We will follow up on the corrective actions until all recommendations have been fully 

implemented. 

 (original signed by:)

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

Assistant Inspector General for 

Healthcare Inspections 

VA Office of Inspector General ii 
Use and Reprocessing of Flexible Fiberoptic Endoscopes at VA Medical Facilities

VA Office of Inspector General 1 

Introduction 

Purpose 

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

received requests from the Secretary, Chairmen and Ranking Members of our oversight 

committees, along with individual members of Congress, to evaluate concerns regarding 

the reprocessing of endoscopic equipment at several VA medical centers (VAMCs), and 

to assess the extent of related problems throughout the Veterans Health Administration 

(VHA). 

The purpose of this review is to describe the pertinent events at VAMCs where problems 

were reported, assess VHA’s response to the events, and conduct a system-wide 

evaluation of current reprocessing practices. 

We performed the inspection in accordance with Quality Standards for Inspections

published by the President’s Council on Integrity and Efficiency. 

Background 

Endoscopy

Endoscopy is a minimally invasive diagnostic procedure that is used to assess the interior 

surfaces of an organ. Endoscopic instruments have rigid or flexible tubes which allow 

visual inspection and photography; they also enable biopsy of tissue and removal of 

foreign objects. 

Although Hippocrates described endoscopic examinations 2,400 years ago, the modern 

era of endoscopy began less than 60 years ago with the development of flexible 

instruments and adequate light sources.1

 Capability for examination of the entire colon 

was developed in the 1970s and colonoscopy came into widespread use thereafter. 

Today, specialists throughout the range of medical and surgical practice employ both 

rigid and flexible endoscopes for diagnosis and treatment. In addition to upper and lower 

gastrointestinal (GI) applications, flexible fiberoptic endoscopy encompasses laparoscopy 

(for the abdomen and pelvis), bronchoscopy (lower airways), cystoscopy (urinary tract), 

arthroscopy (joints), and rhinolaryngoscopy (upper airways), and others. Endoscopic 

procedures are carried out in specially equipped endoscopy suites, operating rooms 

(ORs), and intensive care units. 

Endoscopes vary substantially in length and complexity. Some rhinolaryngoscopes are 

less than 12 inches long and have no internal channels, while GI endoscopes may be 

more than 6 feet long and have three internal channels for application of suction, delivery 

 

1

 Lau WY, Leow CK, Li, AKJ. History of endoscopic and laparoscopic surgery. World J Surg. 1997;21:444-453. 
 

 

Use and Reprocessing of Flexible Fiberoptic Endoscopes at VA Medical Facilities 

of air or water, and for biopsy and other operative procedures. This review addresses 

issues related to the use and reprocessing of flexible fiberoptic endoscopes (FFEs). Rigid 

endoscopes and FFEs used exclusively in sterile OR environments are not considered. 

Reprocessing of Reusable Medical Equipment 

Reusable medical equipment (RME) is categorized based on the associated risk of and 

the level of cleaning required to prevent infection. Devices that enter normally sterile 

tissue, including joints and the vascular system, require sterilization to eliminate all forms 

of microbial life. Other devices, including many FFEs, examine intact mucous 

membranes and do not ordinarily penetrate sterile tissue. For these devices, which are 

often constructed of materials and mechanisms that are unable to withstand exposure to 

the high temperatures or chemicals required for sterilization, high-level disinfection 

(HLD) is appropriate. HLD eradicates all microorganisms “except for small numbers of 

bacterial spores.”2 

Endoscopes must be decontaminated after each use to remove potential sources of 

infection. Individual manufacturers publish specific reprocessing instructions for each 

endoscope and related accessory items (tubing, pumps, etc.). FFE reprocessing includes 

basic cleaning steps and HLD of the instrument and accessories using manual or 

automated processes. Some facilities use automatic endoscope reprocessors designed to 

wash and disinfect FFEs. Whether manual or automated, reprocessing requires the 

following five steps: 

1. Pre-cleaning to remove body fluids and debris from internal and external surfaces. 

This step is typically completed near where the procedure is performed, typically 

by a nurse or technician who brushes each internal channel and flushes each 

channel with water. 

2. Disinfection by immersion in a disinfecting liquid and perfusion of the disinfectant 

into all accessible channels. 

3. Rinsing of all surfaces and channels with sterile, filtered, or high-quality potable 

water to remove the disinfectant. 

4. Flushing of the channels with alcohol to assist in drying the interior channels, 

followed by forced-air drying. 

5. Storage in a dry and well-ventilated environment in accordance with the 

manufacturer’s instructions and hung vertically with control valves and biopsy 

inlet cap removed to facilitate air movement. 

2

 Rutala WA, Weber DJ, and the Healthcare Infection Control Practices Advisory Committee, Centers for 

Disease Control and Prevention. Guideline for Disinfection ad Sterilization in Healthcare Facilities, 

2008. http://www.cdc.gov/ncidod/dhqp/pdf/guidelines/Disinfection_Nov_2008.pdf. Accessed May 28, 

2009. 

VA Office of Inspector General 2 
 

Use and Reprocessing of Flexible Fiberoptic Endoscopes at VA Medical Facilities 

Leak testing and steps 2–4 can occur in a facility’s Supply, Processing, and Distribution 

(SPD) decontamination area or in a designated and appropriately equipped reprocessing 

site near where endoscopy is performed. While access to SPD decontamination areas is 

limited to SPD staff, either SPD or clinic staff can reprocess FFEs at reprocessing sites in 

clinical areas. 

Manufacturers of endoscopic equipment and accessories publish detailed instructions for 

equipment set-up, pre-cleaning, and reprocessing. When a new endoscope is introduced, 

manufacturer representatives typically provide initial training to staff, and some provide 

annual or on-demand refresher training. For the most commonly used endoscopes, 

manufacturer websites are replete with product information, user manuals, and other 

customer-focused documents. 

FFE reprocessing has been shown to have a narrow margin of safety, and any deviation 

from the recommended reprocessing protocol can lead to the survival of microorganisms 

and an increased risk of infection. Endoscopy-related outbreaks of infectious diseases 

have clearly resulted from failures to comply with reprocessing guidelines. 

Although there is no requirement to reports failures in the reprocessing of reusable 

medical equipment and no compilation of occurrences nationwide, media descriptions 

suggest that incidents at non-government hospitals are not rare. For example, in 2004 a 

California hospital sent letters to more than 2,000 patients who had undergone 

endoscopies after a reprocessing machine was found to have malfunctioned,3

 and in 2005 

a hospital in Pennsylvania notified 200 patients when colonoscopes were discovered to 

have been inadequately disinfected.4 

Endoscopy-Related Infection 

Infections associated with GI endoscopy have been estimated to occur at a rate of 1 in 1.8 

million procedures.5

 Although various types of microorganisms can be implicated, 

viruses have been of concern for the greatest numbers of patients because viral infections 

may take months or years to become manifest. The three viruses most often considered 

after lapses in endoscope disinfection are hepatitis B, hepatitis C, and the human 

immunodeficiency virus (HIV). Each of these viruses is readily killed when 

recommended disinfection practices are followed. Proven cases of transmission through 

endoscopy have occurred for hepatitis B and hepatitis C, and have invariably been 

associated with deficiencies in the use or reprocessing of endoscopes or accessories, or 

3

 Torassa U. Endoscopy hygiene a growing problem. San Francisco Chronicle, September 10, 2004. 4

 Fahy J, Spice B. Monroevile hospital urges 200 colonoscopy patients to get checked for hepatitis, HIV. Pittsburgh
 

Post-Gazette, March 31, 2005. 

5

 Schembre DB. Infectious complications associated with gastrointestinal endoscopy. Gastrointest. Endosc. Clin. N. 

Am. 2000;10:215-32. 

VA Office of Inspector General 3 
 

 

 

 

 

 

 

Use and Reprocessing of Flexible Fiberoptic Endoscopes at VA Medical Facilities 

with other lapses in infection control. There are no reported cases of transmission of HIV 

by endoscopes.6 

Endoscopy in VHA 

Endoscopic procedures are frequently performed in VA medical facilities, usually in 

outpatient settings. Table 1 depicts common outpatient endoscopic procedures, excluding 

those performed only in operating rooms (e.g., laparoscopy, arthroscopy). 

Table 1: Number of selected outpatient endoscopic procedures 

performed at VHA facilities in FY09 through May 23, 2009, by 

type of endoscopy. 

GI Endoscopy

 Colonoscopy 142,472 

191,701 

ENT Endoscopy 48,606 

Cystoscopy 49,453 

Bronchoscopy 5,163 

Data Source: VHA Medical SAS Outpatient data file generated May 24, 

2009, based on CPT-4 codes (See Appendix A). 

Inpatient procedures in fiscal year (FY) 2009 (through May 29, 2009) included 599 

colonoscopies and 167 ear, nose, and throat (ENT) endoscopy procedures. 7 

Responsibility for reprocessing endoscopes is described in the VA Handbook, “Supply, 

Processing, and Distribution (SPD) Operational Requirements.”8

 Part 6 of this document 

addresses decontamination and states, in part, “All reusable medical devices used in the 

medical center should be processed in the SPD decontamination area. If there are other 

areas of the medical center where decontamination must be done, all procedures listed in 

this section of the handbook will apply to that area.” The handbook also states that staff 

reprocessing endoscopes “should consult all manufacturers’ instructions.” 

6

 Nelson DB, Muscarella LF. Current issues in endoscope reprocessing and infection control during
 

gastrointestinal endoscopy. World J Gastroenterol. 2006;12:3953-64. 7

 VHA Medical SAS inpatient data file generated May 30, 2009, based on ICD-9 codes. See Appendix A. 

8 VA Handbook 7176, 2002. 

VA Office of Inspector General 4 
 

 

Use and Reprocessing of Flexible Fiberoptic Endoscopes at VA Medical Facilities 

In recent years, several VHA medical facilities have been found to deviate from 

recommended procedures in the reprocessing of endoscopes, in some cases necessitating 

patient recalls. Pertinent events and actions from 2003 through 2007 are detailed below. 

On February 10, 2003, based on problems identified at non-VA facilities, 

the Olympus Corporation issued a safety alert entitled “Reprocessing of 

Auxiliary Water Channel on Olympus EXERATM 

Gastrointestinal 

Endoscopes.” This notice reminded customers that “the auxiliary water 

channel must be reprocessed each time the endoscope is used.” 

On February 13, 2004, the VA National Center for Patient Safety (NCPS) 

issued an alert related to “an incorrect connector being used to link cleaning 

solution to endoscopes during reprocessing.”9 The alert required VHA 

medical facilities to: (1) provide in-service training consistent with 

manufacturer instructions for reprocessing specific models of GI 

endoscopes, and (2) incorporate knowledge of proper handling and 

reprocessing of GI fiberoptic endoscopes into JCAHO competence 

assessment requirements for individuals tasked with this assignment. 

Based on a January 2006 event involving the reprocessing of prostate 

biopsy devices, VHA conducted a national review in September 2006 to 

assess compliance with reprocessing standards. All VHA facilities 

conducted self-assessments and the aggregated results were published in 

2007. Facilities were directed to create local policies based on 

manufacturers’ instructions, including requirements for demonstration of 

competence in performing reprocessing. VHA also planned a reassessment in FY 2008. 

Disclosure and the Clinical Risk Assessment Advisory Board 

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

clinical care to patients or to their personal representatives.10 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 report “Ethical Leadership: Fostering an Ethical Environment and Culture,”11 

which notes: 

Within the Veterans Health Administration (VHA), 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 

9

 NCPS Alert, Proper Connectors for Sterilization of all Gastrointestinal Fiberoptic Endoscopes, February 13, 

2004. 

10 VHA Directive 2008-002, Disclosure of Adverse Events to Patients, January 18, 2008. 11 2007, p. 34.
 

VA Office of Inspector General 5 
 

 

 

Use and Reprocessing of Flexible Fiberoptic Endoscopes at VA Medical Facilities 

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.12 

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.” 

VHA Directive 2008-002 describes three adverse event scenarios and their corresponding 

notification processes: 

1.	 Clinical Disclosure of Adverse Events. This disclosure category pertains to 

disclosure of an adverse event to a single patient at the local level. Generally, 

such events referred to in this subdivision are of a relatively minor nature. An 

example is a medication error that did not result in harm or injury. 

2.	 Institutional Disclosure of Adverse Events. This type of disclosure focuses on 

“cases resulting in serious injury or death, or those involving reasonably expected 

serious injury, or potential legal liability.” In these instances, the need for 

institutional disclosure is recognized, often with detailed clinical counseling and 

advisement of legal options accompanying patient notification. However, like 

“Clinical Disclosure of Adverse Events,” described above, “Institutional 

Disclosure of Adverse Events” refers to disclosure to a single patient of an adverse 

event and its related issues. 

3.	 Large Scale Disclosure of Adverse Events. This type of disclosure is defined as 

“involving a large number of patients, even if at a single facility.”13 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 Deputy Under 

Secretary for Health for Operations and Management (DUSHOM) convene the 

Clinical Risk Assessment Advisory Board (CRAAB), an ad hoc consultative 

board. 

12 National Center for Ethics Report on Ethical Leadership: Fostering an Ethical Environment and Culture, 2007 13 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. 

VA Office of Inspector General 6 
 

Use and Reprocessing of Flexible Fiberoptic Endoscopes at VA Medical Facilities 

CRAAB members include representatives from the Office of the Deputy Under Secretary 

for Health for Operations and Management, 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. 

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 CRAAB 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. 

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: 

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

veterans, resulting from the disclosure itself? 

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

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

c.	 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 CRAAB 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 long-term 

health effect that would require treatment or cause serious illness if untreated.” 

In 2008 the CRAAB has addressed a variety of issues involving a potential need for large 

scale adverse event disclosures. These are briefly summarized: 

•	 In March the CRAAB convened due to problems with the reprocessing of 

endoscopy biopsy valves at a VAMC. The CRAAB minutes note that 714 patients 

who underwent endoscopic procedures may have been exposed to potential harm 

due to incomplete reprocessing of biopsy valves. The CRAAB recommended to 

the PDUSH that these patients be notified for follow-up and testing. 

•	 In June the CRAAB convened due to problems with prostate brachytherapy at a 

VAMC.14 CRAAB minutes noted that up to 63 patients may have received lower 

radioactive doses than prescribed. The CRAAB recommended that the patients be 

notified of possible radiation therapy under dosage. In October the CRAAB reconvened to further explore the issue of radiation under dosing after problems at 

14 Brachytherapy is a form of radiotherapy in which a radioactive source is placed inside or next to the area requiring 

treatment. 

VA Office of Inspector General 7 
Use and Reprocessing of Flexible Fiberoptic Endoscopes at VA Medical Facilities 

other VA facilities were identified. The CRAAB met to track the issue in 

November and December and again in April 2009. 

•	 The CRAAB convened in July to address the issue of improperly reprocessed ENT 

endoscopes at a VAMC. The CRAAB recommended that the VAMC disclose to 

159 affected patients the possibility that the ENT endoscopes may have been 

improperly disinfected. 

•	 Also in July, the CRAAB examined “the events surrounding an issue with 

apparent reuse of syringes for heparin infusion in the cardiac catheterization lab” 

at a VAMC. In this instance, the CRAAB concluded that “a population-based 

notification is not supported when applying the risk guidelines suggested in 

Directive 2008-002,” and so informed the PDUSH. 

VA Office of Inspector General 8 
Use and Reprocessing of Flexible Fiberoptic Endoscopes at VA Medical Facilities 

Section I – Recent Events Involving Endoscope 

Use and Reprocessing 

Scope and Methodology 

We visited the Bruce W. Carter VAMC (Miami) in Miami, FL, and the Tennessee Valley 

Healthcare System-Murfreesboro campus (Murfreesboro) during the week of April 13-

17, and the Charlie Norwood VA Medical Center (Augusta) in Augusta, GA, on May 5-6, 

2009. We interviewed facility directors; Chiefs of Staff, Chiefs of Surgery, Chiefs of 

Medicine, Chiefs of Supply, Processing, and Distribution (SPD), and the Chiefs of 

Infectious Disease; gastroenterologists and other GI staff; Infection Control nurses; and 

other clinical and administrative personnel knowledgeable about the issues. We also 

interviewed the CRAAB chairman and CRAAB members; the VHA National Director 

for Infectious Diseases; the Director and staff of the VA National Center for Patient 

Safety, Food and Drug Administration (FDA) officials; and representatives of endoscope 

manufacturers. 

We reviewed the Administrative Investigation Board (AIB) from Miami and Root Cause 

Analyses (RCAs) from Murfreesboro and Augusta, VHA Directive 2009-004, Use and 

Reprocessing of Reusable Medical Equipment (RME) in Veterans Health Administration 

Facilities (February 2009), memoranda regarding endoscopy issues from medical 

facilities to VA Central Office, CRAAB minutes and correspondence, internal 

investigation documents from facilities and NCPS, SPD self-assessments, inventory 

reports, standard operating procedures (SOPs), incident reports, and follow-up actions 

after NCPS Alerts and memoranda from PDUSH and DUSHOM. 

Findings 

A. Colonoscopy 

Tennessee Valley Healthcare System – Alvin C. York (Murfreesboro) Campus 

Tennessee Valley Healthcare System comprises two campuses, the Alvin C. York 

VAMC (Murfreesboro) and the Nashville VAMC. On December 1, 2008, a patient 

underwent a colonoscopy at Murfreesboro. His was the third and last procedure of the 

day. During this procedure, clinicians noted blood in the tubing of the auxiliary water 

system, which is used during procedures for irrigation. Concerned about equipment 

failure, staff notified the manufacturer and took the equipment out of service. On 

December 4, the Patient Safety Manager (PSM) initiated an investigation, and on 

December 5, the Veterans Integrated Service Network (VISN) leadership was notified. 

On December 8 facility managers ordered an RCA. 

The PSM determined that there was no equipment failure, but that a required one-way 

valve had been absent during the procedure. The PSM also found that two components 

VA Office of Inspector General 9 
 

Use and Reprocessing of Flexible Fiberoptic Endoscopes at VA Medical Facilities 

of auxiliary water system tubing were not being disinfected or discarded according to the 

manufacturer’s instructions. The first piece of tubing, the auxiliary water tube (AWT), 

connects to the colonoscope, is four feet long, and has a one-way valve which prevents 

backflow of bodily fluids into the tube. The second piece of tubing, the washing tube, is 

less than a foot long and has a connector for use during reprocessing of endoscopes. 

The PSM discovered that the AWT was attached to the connector of the washing tube, 

although it was unclear when the switch occurred. Both the one-way valve and the 

connector are light green in color and are roughly the same size and shape. While the 

one-way valve has two “wings,” the connector has only one wing. See Figure 1. 

Figure 1. Connectors switched at Murfreesboro. 

Proximal 

connector 

(no valve) 

Proximal 

connector 

with oneway valve 

Washing 

Tube 

Auxiliary 

Water Tube 

The manufacturer delivers the AWT with tubing and connector attached. These 

components are not meant to be disconnected for any reason, including reprocessing. We 

were unable to determine when or why the switch occurred, nor could we trace the action 

to a specific location or employee. While colonoscope reprocessing is documented and 

can be tracked through the instruments’ serial numbers to a specific technician or nurse, 

the reprocessing of auxiliary tubing and other accessories is not documented. 

In addition to the problem with switched connectors, it was also found that, while the 

colonoscopes themselves were undergoing appropriate reprocessing, AWTs were 

reprocessed at the end of the day rather than after each patient. Further, irrigation tubes, 

VA Office of Inspector General 10 
 

 

 

 

Use and Reprocessing of Flexible Fiberoptic Endoscopes at VA Medical Facilities 

another component of the auxiliary water system, were not discarded at the end of each 

day in accordance with manufacturer instructions. See Figure 2. 

Figure 2. Auxiliary water system and reprocessing requirements for components. 

SPD staff received training in July 2008 specific to the reprocessing of FFEs; however, 

GI nursing staff (who reprocessed colonoscopes until December 1) did not receive this 

training. Further, we found no evidence that GI nursing staff had demonstrated 

competence to clean and reprocess FFE and related accessories. 

On December 12, the Chief of Infectious Disease and GI physicians were tasked with 

completing a risk assessment; on December 15, the risk assessment, which recommended 

notification of the patients who received colonoscopies on December 1, was submitted to 

VISN and NCPS officials. Murfreesboro managers anticipated that VACO would decide 

about notifying these patients. On January 7, 2009, two patients who received 

colonoscopies on December 1 were notified.15 

15 The first of the three patients who had colonoscopy on December 1 can be excluded because colonoscopes and 

accessories are clean for the first use each day. If colonoscopes and tubing/accessories are not properly cleaned 

between patients, cross contamination is possible for subsequent patients receiving procedures that day. 

VA Office of Inspector General 11 
 

 

Use and Reprocessing of Flexible Fiberoptic Endoscopes at VA Medical Facilities 

Murfreesboro managers could not determine with certainty how long the auxiliary water 

tube which had no one-way valve had been in use. Consequently, they decided to notify 

all patients who had undergone colonoscopy from the date that colonoscopes were 

originally received from the manufacturer (April 23, 2003). On February 9 letters were 

sent to 6,387 patients advising them of the potential exposure and offering testing for 

viral diseases. 

National Center for Patient Safety Alert and Subsequently Reported Problems 

On December 22, in response to events at Murfreesboro, NCPS issued a Patient Safety 

Alert regarding the incorrect tube/valve combination and the frequency of reprocessing 

auxiliary water system accessories.16 The Alert emphasized the importance of following 

manufacturer’s instructions. The Alert also required facilities to have SOPs available to 

all personnel who reprocess endoscopes and accessories and that staff be evaluated for 

reprocessing competence. 

Facilities were directed to certify compliance with these action steps by January 7, 2009. 

Sixteen VHA facilities responded that they had not been compliant with reprocessing 

guidelines. Thirteen facilities were reprocessing the AWT at the end of each day or less 

often rather than after each patient. Ten facilities reported that irrigation tubes were 

being reprocessed weekly or less often instead of being discarded at the end of the day. 

The NCPS conducted an onsite assessment of one of the 16 facilities. Based on findings 

from that evaluation and on issues identified at other sites, the NCPS issued an analysis 

of systemic problems with reprocessing throughout VHA (see Appendix B). 

CRAAB Response to Murfreesboro Event 

The December 1, 2008, incident at Murfreesboro raised concerns about possible patient 

exposure to microbial pathogens via contaminated medical equipment. Several questions 

arose, including which patients, if any, should be notified, what information to convey, 

and what patients should be advised to do. 

On December 15, the DUSHOM requested, “that the CRAAB be convened as soon as 

possible to review issues related to appropriateness of cleaning endoscopes...The group 

should review the appropriateness of cleaning endoscopes and determine the number of 

patients who may have been affected by this process. There also may be a need to 

determine the scope of this problem on a national level.” 

The CRAAB met January 9, 12, and 15, and February 6, 2009. At the first meeting, two 

main issues were identified. The first was that of the incorrect connector which had been 

attached to the AWT at Murfreesboro. The second involved the 16 facilities reporting 

non-compliance in response to the December 22 NCPS Alert. 

16 VHA Patient Safety Alert AL09-07, Improper Set-up and Reprocessing of Flexible Endoscope Tubing and 

Accessories December 22, 2008. 

VA Office of Inspector General 12 
 

Use and Reprocessing of Flexible Fiberoptic Endoscopes at VA Medical Facilities 

The CRAAB established that Murfreesboro was the only VAMC facility with this 

problem. The facility could not immediately determine if other patients had undergone 

colonoscopy with the incorrect connector attached. The type of colonoscope used on 

December 1 had been in use at Murfreesboro campus since approximately May 2003. 

At the time of its first meeting on January 9, the CRAAB felt that the risk to patients was 

“small but not zero.” However, the CRAAB noted that a Murfreesboro RCA which 

began on December 8th was due to be completed on January 16, 2009. It deferred 

further conclusions and requested that the RCA include “an assessment of how likely it 

would be for the wrong connector to go unnoticed or undetected, when was the washing 

tube...first used at the Murfreesboro campus?” and whether it was “possible to date when 

the incorrect connector was added to the [auxiliary water tube]...?” 

CRAAB Response to 16 Facilities Reporting Problems After NCPS Alert 

The CRAAB also discussed in its January 9 meeting the 16 VA facilities (other than 

Murfreesboro) that reported reprocessing problems following the NCPS alert. The 

CRAAB noted that at ten facilities accessories “upstream of the one-way check valve 

were being reprocessed incorrectly,” and that different reprocessing instructions for 

components of the auxiliary water subsystem “creates confusion.” The CRAAB 

concluded that even if components are not properly reprocessed, “when the correct antibackflow valve is used, the risk of cross contamination of patients was so small as to be 

clinically insignificant.” The CRAAB “voted unanimously to not require notification of 

patients involved with the incorrect use or reprocessing of components upstream of the 

one way check valve.” 

The CRAAB also discussed the finding that VAMCs had reported “the AWT was being 

reprocessed at the end of each day, instead of after each patient as required by the 

manufacturer's instructions.” The Board concluded that, “To cause possible cross 

contamination of patients by blood borne viruses, viral particles would have to passively 

diffuse 6–7 feet through the auxiliary water channel of the endoscope” in order to 

contaminate the AWT.17 This was felt to be virtually impossible. Nevertheless, before 

dismissing the issue of patient notification, the CRAAB elected to further consider the 

issue at a subsequent meeting. 

The CRAAB determined that the incorrect connector was probably switched sometime 

after the equipment was delivered in 2003. Furthermore, only one of multiple 

Murfreesboro AWTs had the incorrect connector. With regard to the issue of the AWT 

being reprocessed at the end of each day instead of after each patient, the board 

unanimously recommended that because the risk is “clinically insignificant...disclosure 

would not be beneficial to patients.” 

17 The internal diameter of the AWT is 1 millimeter. 

VA Office of Inspector General 13 
Use and Reprocessing of Flexible Fiberoptic Endoscopes at VA Medical Facilities 

The CRAAB limited its considerations to “viral illnesses that resulted from cross 

contamination,” and even more specifically, hepatitis B, C and HIV. The CRAAB noted 

that it would take a prolonged time period, e.g., months to years for such infection to 

become apparent. In contrast, the CRAAB noted, “bacterial cross contamination would 

result in illness within days of the endoscopy.” 

Other engineering issues were discussed, and the CRAAB received a report about the 

NCPS’s discussions with the colonoscope manufacturer, as well as microbiological 

testing that the manufacturer had performed to assess worst case scenarios of hepatitis B, 

hepatitis C, and HIV infection. 

The CRAAB queried the 13 VAMCs that were not reprocessing the AWT after each 

patient to ascertain their practices with respect to use of the auxiliary water system. The 

CRAAB’s concern was that if the AWT is not changed after each patient and is not 

connected prior to the procedure and water flushed through the endoscope (or becomes 

disconnected anytime during the procedure), it could be contaminated by back flow. 

Also in this CRAAB meeting, bacterial cross contamination was discussed further. The 

CRAAB “decided that we should not deal with this issue because any clinical adverse 

bacterial event would have already occurred within days of the procedure and it would be 

impossible to determine if the bacterial infection resulted from the patient's colonic flora 

or from cross contamination. The risk of bacterial infection would not be expected to 

have serious or long-term consequences for the patient and therefore would not seem 

appropriate to disclose to the patient so far after the event had occurred.” 

On February 6 the CRAAB evaluated data provided by the colonoscope manufacturer 

demonstrating that the AWT one-way valve prevents backflow when used properly. 

In light of continued uncertainty as to precisely when the connectors were switched – 

despite multiple explorations of this issue both at by Murfreesboro and the NCPS – the 

CRAAB “voted unanimously to recommend disclosure to all patients” who had 

colonoscopy at Murfreesboro from April 23, 2003 to December 1, 2008. The CRAAB 

indicated that, “These patients should be offered serologic testing for Hepatitis B & C 

and HIV.” However, the CRAAB noted that, “This recommendation does not apply to 

... patients who had the first colonoscopy of each day.” The CRAAB concluded that 

patient notification was not warranted at the 13 VAMCs performing incorrect 

reprocessing of AWTs because none of these facilities reported connecting the AWT to 

the colonoscope after the procedure had begun. 

Step-Up Week 

On February 4, 2009, the PDUSH and DUSHOM sent a memorandum to all VA medical 

facilities announcing “Endoscopy Step-Up Week” for March 8-14 requiring that facilities 

ensure they have: 

VA Office of Inspector General 14 
Use and Reprocessing of Flexible Fiberoptic Endoscopes at VA Medical Facilities 

•	 Locally-developed device-specific SOPs meeting manufacturers’ requirements for 

set-up and reprocessing of all endoscopes. 

•	 Evaluations of model-specific competence for appropriate personnel who set-up 

and/or reprocess endoscopic equipment. 

•	 Assured accountability for reprocessing procedures in all areas and at all levels of 

the organization. 

The memorandum did not require reporting or certification of compliance to the 

DUSHOM. 

On February 9, 2009, VHA issued Directive 2009-004, Use and Reprocessing of 

Reusable Medical Equipment (RME) in Veterans Health Administration Facilities. This 

Directive formalizes the requirements specified in the February 4 memorandum. 

Bruce W. Carter VA Medical Center, Miami, Florida 

Miami managers responded to NCPS Alert 09-07 on January 5, 2009, indicating no 

problems with endoscopy equipment. At this facility, colonoscope reprocessing was 

done by an SPD technician (tech) assigned to the GI procedure area. The SPD tech 

reported to the Chief of SPD, who in turn reported to the Chief of Acquisition and 

Materiel Management Service (A&MMS). 

The Chief, A&MMS, coordinated the Alert response and asked the Chief of SPD to 

certify compliance. The SPD Chief searched inventory files and concluded that the AWT 

had never been purchased. The SPD tech responsible for reprocessing colonoscopes in 

the GI area reported that he had never seen the AWT. While the Chiefs of A&MMS and 

SPD told us that GI reported they did not use AWT, GI staff told us that they only 

reported they were in compliance with the Alert because their AWTs had the proper oneway valve attached. GI staff told us that they did not realize that the second page of the 

Alert addressed reprocessing issues. 

On February 11, a manufacturer representative visited the GI clinic and recommended 

use of disposable tubing in place of the AWT. Without proper approval, the GI staff put 

the sample tubing into trial use. On March 4, 2009, a GI nurse requested that SPD 

purchase the disposable tubing, and the Chief, A&MMS, thereby learned that the AWT 

was in fact in use at the time of the Alert. 

In preparation for Step-Up Week, a facility team evaluated the equipment used in the GI 

suite and also found that the AWT was being used. The team discovered that procedures 

for set-up, use, and reprocessing of colonoscopes were not in accordance with 

manufacturer’s recommendations. The AWT was not reprocessed after each patient, but 

rather was only flushed or rinsed with sterile water and never sent to SPD for 

sterilization. 

VA Office of Inspector General 15 
Use and Reprocessing of Flexible Fiberoptic Endoscopes at VA Medical Facilities 

On March 5 the VISN was notified and on March 6 a memorandum was forwarded to the 

DUSHOM. Use of disposable tubing was discontinued on March 12, and all auxiliary 

water system pumps were removed. On March 16 the medical director of the Infection 

Control Program conducted a risk assessment and concluded that “while the consequence 

of transmission of disease was clinically significant, the probability of transmission is 

substantially less than 1 in 10,000.” It was estimated that the number of potentially 

affected veterans was somewhere between 5,000 and 10,000. However, it was noted that 

this estimate included all patients who underwent colonoscopy with irrigation capacity, 

even though not every patient had irrigations done or the tubing connected. 

At the request of the DUSHOM, on March 16, 2009, the CRAAB met to review issues at 

Miami; findings included: 

•	 The AWT and other accessories were not sterilized prior to initial use. 

•	 The AWT was not reprocessed between patients. 

•	 None of the irrigation components had been changed or reprocessed since May 

2004 when the equipment arrived onsite. 

Further, it was found that at this facility clinicians connected the auxiliary water system 

to the colonoscope after the procedure was already in progress in approximately half of 

all procedures. The committee believed that this practice, when combined with the 

absence of AWT reprocessing, posed a low but significant risk for cross contamination of 

blood borne pathogens. 

On March 17, the CRAAB unanimously recommended disclosure to all Miami patients 

who had colonoscopy with use of the AWT between May 2004 and February 12, 2009. 

The PDUSH directed disclosure, and the medical center mailed 3,260 letters to veterans 

determined to be at risk, advising them of their potential exposure and offering serologic 

testing for hepatitis B, hepatitis C, and HIV. 

On March 26, 2009, a manufacturer’s representative, in the course of providing training 

on the AWT, found debris in the auxiliary water channel while flushing a colonoscope 

presumed to be clean. Other colonoscopes presumed to be clean were tested with the 

same result. All GI endoscopic procedures were discontinued pending review by the 

VHA Infectious Diseases Program Office (IDPO). On March 27, the IDPO 

recommended that colonoscopy without use of the auxiliary water channel be resumed, 

but that colonoscopes with the auxiliary water channel not be placed back into use until 

the manufacturer validated their safety. 

The VISN 8 Network Director chartered an AIB to review the issues at Miami. The AIB 

found serious problems with inventory control, oversight, supervision, training, 

communication, and competence assessment related to endoscopy equipment. On 

VA Office of Inspector General 16 
Use and Reprocessing of Flexible Fiberoptic Endoscopes at VA Medical Facilities 

April 2, the AIB reported that endoscope reprocessing is “incomplete and not according 

to device-specific manufacturer’s instructions.” 

A team from another VAMC provided training and verified competence of Miami SPD 

staff responsible for colonoscope reprocessing. Manufacturer’s representatives provided 

additional training. The IDPO returned to the MVAMC on April 8 for a follow-up site 

visit and found that SPD technicians were properly cleaning the endoscopes. 

During our site visit April 15-16, we reviewed both SPD and GI staff training records and 

did not find device-specific competencies. We subsequently received copies of 

certification of competence for reprocessing staff. 

B. ENT Endoscopy 

Charlie Norwood VA Medical Center, Augusta, Georgia 

On November 4, 2008, a patient in the ENT clinic at the Augusta VAMC questioned the 

method by which a nurse was cleaning a laryngoscope. The patient, who had already had 

his endoscopic procedure, read instructions on the box of disposable sanitizing cloths 

being used by the nurse. The instructions stated that they should not be used as a means 

to clean equipment that comes in contact with mucous membranes. At the time of the 

event, ENT endoscopes were cleaned in the ENT clinic by nursing staff; they were not 

undergoing HLD. 

An ENT physician reported the patient’s concern to the Chief of Surgery, who then 

notified the medical center’s epidemiologist and Chief of SPD. On November 5 the 

Chief of Surgery closed the ENT clinic pending completion of a preliminary 

investigation. The ENT clinic resumed seeing patients on November 12 following staff 

training. 

The medical center began an investigation into the issue on November 21. Following an 

extensive review and consultation with experts, recommendations and an action plan 

regarding patient notifications were finalized January 20. On January 28, the DUSHOM 

requested that a CRAAB review Augusta’s “failure to follow recommended disinfection 

and sterilization guidelines for cleaning endoscopes...” in the ENT clinic. After 

consideration of the facts, the PDUSH concluded that notification was warranted and 

CRAAB involvement unnecessary. On February 9 notification letters were sent to 1,069 

affected ENT patients. 

The investigation revealed that a nurse assigned to the ENT clinic from 1999 to January 

2008 had been properly cleaning endoscopes per manufacturer’s guidelines. In January 

2008, that nurse transferred to another position in the medical center and a nurse with no 

experience working with endoscopes was assigned to ENT. The new nurse told us that 

she received 2-3 days of orientation from the outgoing nurse, and that she was 

VA Office of Inspector General 17 
Use and Reprocessing of Flexible Fiberoptic Endoscopes at VA Medical Facilities

specifically told to use the sanitizing cloths to clean laryngoscopes. She did not observe a 

laryngoscope being cleaned. This nurse further stated that, after asking staff from the 

Medical College of Georgia how laryngoscopes were cleaned there, expressed concerns 

to the ENT Clinic Chief and Chief of SPD in June or July 2008. 

In addition to an epidemiologist’s investigation, medical center managers also directed 

the Risk Manager and Quality Manager to investigate staff actions, and chartered a Root 

Cause Analysis (RCA) team to evaluate system and process issues that could have 

contributed to the event. Those reports were submitted on February 11 and March 4, 

respectively. 

Prior to the November 4 event, FFE reprocessing SOPs had not been updated since 2001; 

in addition, staff responsible for FFE reprocessing did not have adequate documentation 

of competence assessments. When we visited Augusta in May 2009, the facility still did 

not have documentation of device-specific competence, which was the standard used in 

this national assessment. 

Section II – National Assessment of Reprocessing 

Practices in VHA 

Scope and Methodology 

We reviewed applicable regulations, policies, procedures, and guidelines. Twenty-six 

inspectors conducted unannounced onsite visits for the total of 42 probability-based 

randomly selected VHA facilities to examine pertinent endoscope reprocessing 

documentation. 

To prepare for the unannounced onsite inspection, we emailed a request to the directors 

of VHA facilities for information on colonoscopy and ENT endoscopy on April 27, 2009. 

This request asked for the following information: (1) a list of the manufacturer and model 

number for each colonoscope in active use at each procedure location and reprocessing 

location, including clinics, (2) reprocessing locations for ENT endoscopes, including 

clinics, and (3) the administrative section responsible for completing performance 

evaluations for HLD staff at each reprocessing location. 

Study Populations

The study population for colonoscope (or ENT endoscope) reprocessing consisted of all 

colonoscope (ENT endoscope) HLD reprocessing units in VHA facilities as of April 27, 

2009. A VHA facility may have more than one endoscope reprocessing location, and 

each of the reprocessing units was counted. For example, a facility may reprocess 

colonoscopes both in its GI procedure suite/room and at its OR, and thus two HLD 

reprocessing units would be counted for that facility. In addition, a facility may send its 

VA Office of Inspector General 18 
Use and Reprocessing of Flexible Fiberoptic Endoscopes at VA Medical Facilities 

endoscopes to another facility for HLD reprocessing; no reprocessing unit would be 

counted for the sending facility. 

To identify the study populations, we first ascertained all VHA facilities that performed 

colonoscopy and ENT endoscopy. We extracted two (self-reported) lists of VHA 

facilities from the facility responses to the information request email of April 27: one for 

facilities that reported performing colonoscopy, another for the ENT endoscopy. A 

facility that reported performing both endoscopies would be on both lists. Independently, 

we generated the (workload) lists of facilities from the FY 2009 VHA outpatient medical 

SAS data file where colonoscopy and/or ENT endoscopic procedures were performed, 

based on CPT-4 codes (see Appendix A). The self-reported and the workload facility 

lists for each endoscopy were compared and the discrepancies between the lists were 

resolved to ensure the completeness of ascertainment of VHA colonoscopy and ENT 

endoscopy facilities. 

We established the study populations by including the distinct endoscope HLD 

reprocessing units within colonoscopy and ENT endoscopy facilities. The distinct 

reprocessing locations, separately for colonoscopes and ENT endoscopes within each 

endoscopy facility, were determined by the self-reported information from facility 

responses to the email request. For example, if a facility performed colonoscopy both in 

its GI procedure suites and its OR, and the facility reprocessed all colonoscopes in a 

central SPD location, then the facility would be counted as having only one reprocessing 

location (SPD). 

Sample Design 

Separate, detailed onsite inspections were conducted at Miami, Murfreesboro, and 

Augusta. Therefore, these facilities and their associated hospitals and clinics were 

excluded from our sample selection for the unannounced onsite inspection. We also 

excluded the VA Maryland Healthcare system (Baltimore and Perry Point VAMCs), 

where we conducted exploratory information gathering, and the Alaska VA Healthcare 

System because of its geographic distance. 

Because of the unannounced nature of the inspections and for cost-efficiency, a stratified 

clustering sample design was employed to maximize the number of facilities that could 

be inspected in a single day. Two probability-based random samples of VHA endoscope 

reprocessing facilities were selected from the study populations for the unannounced 

onsite inspection: one for colonoscope reprocessing and another for ENT endoscope 

reprocessing. With probability sampling, each unit in the study population has a known 

positive probability of selection. This property of probability sampling avoids selection 

bias and allows use of statistical theory to make valid inferences from the sample to the 

study population. 

VA Office of Inspector General 19 
Use and Reprocessing of Flexible Fiberoptic Endoscopes at VA Medical Facilities

After identifying endoscope reprocessing facilities, we first combined associated facilities 

into a cluster of facilities that includes the VAMC and associated clinics (if any) where 

endoscopes are reprocessed. In addition to sharing the same administrative leadership, 

facilities within a cluster are generally close geographically, making feasible same-day 

site visits within a cluster. 

We then categorized each cluster of facilities into one of the following three strata: 

• The “colonoscope” stratum of facilities performing only colonoscopy. 

• The “ENT endoscope” stratum of facilities performing only ENT endoscopy. 

• The “both” stratum of facilities performing both colonoscopy and ENT 

endoscopy. 

A facility cluster is classified into the “colonoscope” (or “ENT endoscope”) stratum if all 

facilities within a cluster performed only colonoscopy (or ENT endoscopy), and 

classified into the “both” stratum if otherwise. For example, if a VAMC performs only 

colonoscopy and one of its clinics performs only the ENT endoscopy, the cluster of the 

VAMC and its clinics is classified as “both.” 

Because of the distance from the Fort Harrison VAMC (Montana) to its Billings clinic, 

we grouped Fort Harrison only with its clinic in Missoula as one cluster, and paired the 

Billings clinic with the Sheridan VAMC (Wyoming) as another cluster for sampling. 

This intentional splitting and pairing permitted one inspector to conduct site visits at Fort 

Harrison and Missoula and another inspector to visit Sheridan and Billings all on the 

same day. 

We randomly selected 26 clusters of facilities from the strata, with unequal probability of 

selection. The facility clusters that performed both endoscopic procedures and had more 

than two facilities were over sampled to maximize the number of facilities visited on the 

same day. A total of 42 (28.4 percent) VHA facilities were selected for inspection from 

among 148 VHA facilities engaged in endoscopy. Among the 42 sampled facilities, 9 

facilities performed only colonoscopy, 6 only ENT endoscopy, and 27 both. 

This complex sample design included stratification, clustering, and unequal probabilities 

of selection. 

Site Visits for Document Examination

Twenty-six healthcare inspectors trained for this project conducted unannounced site 

visits on May 13, 2009, at the 42 sample facilities to examine pertinent documentation. 

Up to three facilities were visited by each inspector; six inspectors conducted a third site 

visit on May 14. 

VA Office of Inspector General 20 
Use and Reprocessing of Flexible Fiberoptic Endoscopes at VA Medical Facilities 

At each reprocessing location within a facility, the inspector asked for all model-specific 

SOPs and competence records for colonoscope reprocessing (if the facility performed 

only colonoscopy), for ENT endoscopes (if only ENT), or both if applicable. For the 

colonoscope reprocessing, the inspector checked the located SOPs and competence 

records against each model listed for that reprocessing location. The reprocessing 

location model list was compiled before the site visit based on information provided in 

response to our email request. 

After completing the inspection at each facility, the inspector briefed the facility director 

or designee on whether the inspector found (or did not find) model-specific instructions 

and model-specific competence records for reprocessing endoscopes. 

Presence of Endoscope Reprocessing SOPs 

During the unannounced site inspection, inspectors verified whether SOPs for each model 

of colonoscopes were readily accessible at the colonoscope reprocessing location. At 

ENT endoscope reprocessing location, we verified whether there was at least one model 

specific reprocessing SOP for any ENT endoscope, regardless of the number of model 

types. SOPs in printed or electronic formats were acceptable. SOPs were considered 

absent if they were not in the immediate area or were in a locked space (e.g., someone’s 

room or desk). 

Presence of Endoscope Reprocessing Competence Records 

At each colonoscope reprocessing location, we determined the presence or absence of at 

least one reprocessing competence record dated May 1, 2008, or later for each of the 

specific models of colonoscopes reprocessed there. At each ENT endoscope reprocessing 

location, we verified whether there was at least one model specific reprocessing 

competence record for any ENT endoscope, regardless of the number of ENT endoscope 

model types. If competence records were not accessible during our visit, the facility was 

instructed to fax the records to us within 24 hours. If records were not received, we 

counted the competence records as absent. 

Statistical Analysis 

For manufacturers other than Olympus, we considered the colonoscope reprocessing SOP 

to be present at a reprocessing location if any manufacturer model-specific SOP was 

accessible to reprocessing staff. For example, if a Pentax 70K series colonoscope SOP 

was present at a reprocessing location, we counted the SOP as present for all Pentax 

models. 

The presence or absence of an auxiliary water channel is an additional reprocessing issue 

for many colonoscopes. The 180-series and some 160-series colonoscopes include an 

auxiliary water system. We therefore classified the model-specific SOP as “present” for 

VA Office of Inspector General 21 
 

Use and Reprocessing of Flexible Fiberoptic Endoscopes at VA Medical Facilities 

all Olympus models (with or without the auxiliary water system) reprocessed at a 

reprocessing location if any model-specific SOP for Olympus colonoscopes with 

auxiliary water channel was present. However, the presence of SOPs for colonoscopes 

without auxiliary water counted only for Olympus models that do not use the auxiliary 

water system. 

The following is a list of all 160- and 180-series Olympus colonoscopes with an auxiliary 

water system sold in the U.S.: CF-Q160L, CF-Q160I, CF-Q160AL, CF-Q160AI, CFQ180AL, CF-Q180AI, PCF-Q180AL, PCF-Q180AI, CF-H180AL, CF-H180AI, PCFH180AL, and PCF-H180I.18 We used this list to classify all Olympus colonoscopes as 

with or without auxiliary water. 

Therefore, we categorized each colonoscope into one of the following five types for the 

purpose of this review: 

• Olympus with an auxiliary water system. 

• Olympus without an auxiliary water system. 

• Pentax. 

• Fujinon. 

• Storz. 

For each colonoscope reprocessing location, we classified that reprocessing unit as “SOP 

compliant” if all model-specific reprocessing SOPs were present for applicable 

colonoscopes; as “competence compliant” if at least one demonstrated model-specific 

competence record existed for each applicable endoscope; and as “compliant” if it was 

both “SOP compliant” and “competence compliant.” Note that if the SOP (competence 

record) for an Olympus colonoscope with an auxiliary water system was present at a 

reprocessing location, it was also counted as the SOP (competence record) for Olympus 

colonoscopes without an auxiliary water system, but not vice versa. 

For each ENT endoscope reprocessing location, we classified the reprocessing unit as 

“SOP compliant” if any model-specific reprocessing SOP was present, as “competence 

compliant” if at least one demonstrated model-specific competence record was present, 

and “compliant” if both “SOP compliant” and “competence compliant.” 

We estimated the percentage of “SOP compliance,” “competence compliance,” and 

“compliance” for all reprocessing units in VA medical facilities, separately for 

colonoscope and ENT endoscope reprocessing. Horvitz-Thompson sampling weights, 

which are the reciprocal of sampling probabilities, were used to account for our unequal 

probability sampling. To take into account our complex sample design with stratification 

and clustering, the jackknife replicate-based method was employed to obtain the 

sampling errors for the estimates. 

18 Communication with representative of Olympus America, Inc., May 22, 2009. 

VA Office of Inspector General 22 
Use and Reprocessing of Flexible Fiberoptic Endoscopes at VA Medical Facilities 

We present a 95 percent confidence interval for the true compliance (parameter) of the 

study population. A confidence interval gives an estimated range of compliance values 

(being calculated from a given set of sample data) that is likely to include an unknown 

population parameter. The 95 percent confidence interval indicates that among all 

possible samples we could have selected of the same size and design, 95 percent of the 

time the population parameter would have been included in the computed intervals. 

Percentages can take only positive values from zero to 100, but their logits have an 

unrestricted range; hence, the normal approximation can be used to estimate the 

parameters. We thereby calculated the confidence intervals for percentages on the logit 

scale and then transformed them back to the original scale to ensure that the calculated 

confidence intervals contained only the proper range of zero to 100 percent. 

All data analyses were performed using SAS statistical software (SAS Institute, Inc., 

Cary, NC), version 9.2 (TS1M0). Maps were produced using ArcGIS software 

(Environmental Systems Research Institute, Redlands, CA), version 9.2. 

VA Office of Inspector General 23 
Use and Reprocessing of Flexible Fiberoptic Endoscopes at VA Medical Facilities 

Findings 

As of April 27, 2009, 156 VA medical facilities were performing colonoscopy and/or 

ENT endoscopy. After excluding facilities associated with Miami, Murfreesboro, 

Augusta, and the Alaska and Maryland Healthcare Systems, we randomly selected 42 

(28.4 percent) VHA facilities from among the remaining 148 VHA facilities engaged in 

endoscopy using probability-based stratified clustering sampling for our unannounced 

inspections (Figure 3). Two of the 36 colonoscopy-only facilities each reprocessed their 

colonoscopes at two different locations, and four of the 33 ENT-only endoscopy facilities 

each reprocessed their endoscopes at two different locations. Therefore, 38 HLD 

colonoscope reprocessing units and 37 HLD ENT endoscope reprocessing units were 

subject to our unannounced onsite documentation inspection. 

Figure 3. Sampling pathway for unannounced onsite inspections at 

VHA colonoscopy and ENT endoscopy facilities. 

Appendix C lists the 42 sample VHA facilities where we conducted unannounced 

inspections. Figure 4 depicts geographically the 42 facilities we inspected and the 106 

VHA endoscopy facilities that were included for review but were not selected for 

inspection. It shows that we visited 16 of the 21 Veterans Integrated Service Networks 

VA Office of Inspector General 24 
Use and Reprocessing of Flexible Fiberoptic Endoscopes 

Alaska Hawaii Guam NOTE: Alaska is in VISN 20, Hawaii and Guam are in VISN 21, and Puerto Rico and the Virgin Islands are in VISN 8. 

0 125 250 500 

Miles 

0 250 500 

Miles 

LE

To

Figure 4. VHA Endoscopy facilities included in unannounced onsite inspections. 

Excluded were Miami, the Tennessee Valley Healthcare System, Augusta, and their associated facilities because separate were conducted at Miami, Murfreesboro, and Augusta. Also excluded were the Maryland Healthcare System, where we coinformation gathering, and the Alaska Healthcare System, because of its geographic distance. VA Office of Inspector General 
Use and Reprocessing of Flexible Fiberoptic Endoscopes at VA Medical Facilities 

A. Responsibility for Reprocessing Endoscopes in VHA, Based on Facility SelfReported Information 

We sent an email request to the directors of VHA facilities for information on 

colonoscopy and ENT endoscopy on April 27, 2009, including the administrative section 

responsible for completing performance evaluations for HLD staff at each reprocessing 

location. Analyses included data from facilities excluded from sample inspections. 

Table 1 illustrates the distribution of 159 colonoscope reprocessing locations within the 

145 VA medical facilities engaged in colonoscopy as of April 27, 2009, based on facility 

self-reported information. It shows that 131 (90 percent) of the 145 VHA colonoscopy 

facilities used one colonoscope reprocessing location and about two out of three (68 

percent) were at a GI procedure suite/room. Among the 14 facilities that reprocessed 

their colonoscopes at two different locations, 5 (36 percent) facilities reprocessed at a 

procedure room and at SPD, while 8 (57 percent) facilities processed both at a procedure 

room and at an OR. 

Table 1. Distribution of 159 colonoscope reprocessing 

locations within 145 VHA colonoscopy facilities. 

Procedure Room 90 

SPD 37 131 facilities with a single 

reprocessing location 

OR 4 

Procedure Room + SPD 5 

Procedure Room + OR 8 14 facilities with two 

reprocessing locations 

OR + Mobile 1 

Table 2 tabulates reprocessing supervisory responsibility by colonoscope reprocessing 

location. Overall, SPD staff supervised about 41 percent of VHA reprocessing units 

where colonoscopes were reprocessed. In terms of reprocessing locations, reprocessing 

units located at SPD were more likely to be supervised by SPD staff (81 percent), while 

reprocessing units located at procedure suite/room were more likely to be supervised by 

non-SPD staff (76 percent: 53 percent by nursing staff and 23 percent by GI staff). 

VA Office of Inspector General 26 
 

    

Use and Reprocessing of Flexible Fiberoptic Endoscopes at VA Medical Facilities 

Table 2. Distribution of reprocessing supervisory responsibility by 

colonoscope reprocessing location. 

Reprocessing staff supervision 

SPD Non-SPD 

HLD reprocessing Nursing GI Total 

location 65 (40.9%) 69 (43.4%) 25 (15.7%) 159 (100%) 

Procedure Room 24 (23.3%) 55 (53.4%) 24 (23.3%) 103 

SPD 34 (81.0%) 8 (19.0%) 0 (0.0%) 42 

OR 6 (46.2%) 6 (46.2%) 1 (7.7%) 13 

Mobile 1 (100.0%) 0 (0.0%) 0 (0.0%) 1 

Note: Percentages may not add to exactly 100% due to rounding. 

Table 3 tabulates the distribution of 144 ENT endoscope reprocessing locations within 

the 125 VHA ENT endoscopy facilities. In contrast to colonoscope reprocessing, most of 

the facilities reprocessed ENT endoscopes at SPD locations. Among the 125 facilities, 

106 (85 percent) facilities reprocessed its endoscopes at one location and 69 percent of 

them were at SPD. Among the 19 facilities that reprocessed their endoscopes at two 

different locations, all of them included a procedure room and 16 (84 percent) included 

SPD. 

Table 3. Distribution of 144 ENT endoscope reprocessing 

locations at 125 VHA ENT endoscopy facilities. 

Procedure Room 31 

SPD 73 

Facilities with a 

single reprocessing 

location OR 2 

Procedure Room + SPD 16 

Procedure Room + OR 2 

Facilities with two 

reprocessing 

locations 2 Different Procedure Rooms 1 

Table 4 gives the distribution of reprocessing supervisory responsibility by ENT 

endoscope reprocessing location. In contrast to colonoscope reprocessing, overall, SPD 

staff supervised 60 percent of locations where ENT endoscope were reprocessed. As with 

colonoscope reprocessing, reprocessing units located at SPD were more likely to be 

supervised by SPD staff (85 percent), while reprocessing units located at procedure 

suite/room were more likely to be supervised by non-SPD staff (82 percent: 65 percent by 

nursing staff and 18 percent by GI staff). 

VA Office of Inspector General 27 
 

Use and Reprocessing of Flexible Fiberoptic Endoscopes at VA Medical Facilities 

Table 4. Distribution of reprocessing supervisory responsibility by 

ENT endoscope reprocessing location. 

Reprocessing staff supervision 

SPD Non-SPD 

HLD reprocessing Nursing ENT Total 

location 87 (60.4%) 47 (32.6%) 10 (6.9%) 144 (100%) 

Procedure Room 9 (17.6%) 33 (64.7%) 9 (17.6%) 51 

SPD 76 (85.4%) 12 (13.5%) 1 (1.1%) 89 

OR 2 (50.0%) 2 (50.0%) 0 (0.0%) 4 

Note: Percentages may not add to exactly 100% due to rounding. 

B. Compliance with VHA Directive 2009-004 Based on Unannounced Onsite 

Inspection 

VHA Directive 2009-004 (February 9, 2009), Use and Reprocessing of Reusable Medical 

Equipment (RME) in Veterans Health Administration Facilities, requires (page 3) that 

“device-specific SOPs for set up and reprocessing of RME are posted in any area where 

these devices are reprocessed.” It defines (page 1) 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 (pages 2–3). We checked for the presence of all five applicable modelspecific SOPs and competence records at each colonoscope reprocessing location and any 

model-specific SOPs and any competence records at each ENT endoscope reprocessing 

location that were sampled for unannounced onsite inspection. 

Issue 1. Absence of Colonoscope Model-Specific Reprocessing SOPs and/or 

Competence Records 

Table 5 reports the compliance of the 38 reprocessing locations at the 36 colonoscopy 

facilities we inspected (two of the 36 facilities each had two reprocessing units). It also 

gives the estimated compliance of VHA reprocessing units based on our sampled data. As 

indicated in the Statistical Analysis section, we classified the reprocessing unit as “SOP 

compliant” if all applicable model-specific reprocessing SOPs were present at its 

location; as “competence compliant” if at least one demonstrated model-specific 

competence record existed for each type applicable model-specific endoscopes; and 

“compliant” if both “SOP compliant” and “competence compliant.” 

VA Office of Inspector General 28 
Use and Reprocessing of Flexible Fiberoptic Endoscopes at VA Medical Facilities 

Table 5. Sample and VA estimates of compliance with standard operating 

procedures and competence in accordance with VHA directive 2009-004: 

Colonoscope Reprocessing. 

VA Estimates 

Compliance 

Sample (38 

units) 

Compliance Compliance (95% Confidence 

Interval) 

Standard Operating 

Procedure 81.6% 77.9% (59.5%, 89.4%) 

Competence 52.6% 50.2% (31.6%, 68.8%) 

Compliance With 

Both SOP & 

Competence 

47.4% 42.5% (26.7%, 60.1%) 

Of the sampled colonoscope reprocessing units, 82 percent were in compliance with 

SOPs, 53 percent with competence, and 47 percent were in compliance with both SOPs 

and competence. After taking into account our complex sample design, we estimated that 

78 percent of VHA colonoscope reprocessing units were in compliance with SOPs, and 

we are 95 percent confident that the true compliance value was somewhere from 59.5 

percent to 89.4 percent. We estimated that only about one out of two VHA colonoscope 

reprocessing units (50.2 percent) was in compliance with competence and we are 95 

percent confident that the true compliance value varied somewhere from 31.6 percent to 

68.8 percent. The compliance with both SOPs and competence was estimated at 42.5 

percent with the 95 percent confidence interval from 26.7 to 60.1 percent. 

Issue 2. Absence of ENT Endoscope Model-Specific Reprocessing SOPs and/or 

Competence Records 

Table 6 shows the compliance of the 37 ENT endoscope reprocessing units at the 33 

facilities we inspected (four of the 33 facilities each had two reprocessing units). It also 

gives the estimated compliance of VHA reprocessing units based on our sampled data. 

Note that we classified an ENT endoscope reprocessing unit as “SOP compliant” if any 

model-specific reprocessing SOPs was present at its location; as “competence compliant” 

if at least one demonstrated model-specific competence record existed; and “compliant” 

if both “SOP compliant” and “competence compliant.” 

VA Office of Inspector General 29 
Use and Reprocessing of Flexible Fiberoptic Endoscopes at VA Medical Facilities 

Table 6. Sample and VA estimates of compliance with standard operating 

procedures and competence in accordance with VHA directive 2009-004: 

ENT Endoscope Reprocessing. 

VA Estimates 

Compliance 

Sample (37 

units) 

Compliance Compliance (95% Confidence 

Interval) 

Standard Operating 

Procedure 73.0% 76.9% (58.9%, 88.6%) 

Competence 56.8% 54.7% (34.9%, 73.2%) 

Compliance With Both 

SOP & Competence 48.6% 47.3% (28.9%, 66.5%) 

Of the sampled 37 ENT endoscope reprocessing units, 73 percent were in compliance 

with SOPs, 57 percent with competence, and 49 percent with both SOPs and competence. 

After taking into account our complex sample design, we estimated that 77 percent of 

ENT endoscope reprocessing units were in compliance with SOPs, and we are 95 percent 

confident that the true compliance value was somewhere from 58.9 percent to 88.6 

percent. We estimated that 55 percent of VHA ENT endoscope reprocessing units were 

in compliance with competence and we are 95 percent confident that the true compliance 

value varied somewhere from 34.9 percent to 73.2 percent. The compliance with both 

SOPs and competence was estimated at 47 percent with the 95 percent confidence 

interval from 28.9 to 66.5 percent. 

Issue 3. Compliance and Responsibility for Reprocessing Endoscopes 

Tables 7 and 8 detail the estimated compliance of VHA reprocessing units (based on our 

sample data), separately for colonoscope and ENT endoscope, by the facility selfreported administrative section responsible for completing performance evaluations for 

HLD staff at reprocessing locations. Although not statistically significant, the data 

suggest that VHA colonoscopy reprocessing units supervised by GI were in somewhat 

better compliance than units supervised by SPD or Nursing, and for ENT reprocessing 

units supervised by Nursing and ENT were in somewhat better compliance than units 

supervised by SPD. 

VA Office of Inspector General 30 
 

Use and Reprocessing of Flexible Fiberoptic Endoscopes at VA Medical Facilities 

Table 7. Estimated VA colonoscope reprocessing compliance with standard operating 

procedures and competence in accordance with VHA directive 2009-004 by supervisory 

staff. 

Competence Compliance With Both Supervisory Staff SOP Compliance Compliance SOP & Competence 

(95% Confidence Intervals) (95% Confidence Intervals) (95% Confidence Intervals) 

SPD 

(10 sampled 

reprocessing units) 

56.2% (19.3%, 87.3%) 54.6% (17.2%, 87.4%) 40.0% (10.3%, 79.4%) 

Nursing 

(19 sampled 86.3% (55.8%, 96.9%) 38.2% (16.6%, 65.7%) 38.2% (16.6%, 65.7%)
 

reprocessing units) 

GI 

(9 sampled 

reprocessing units) 

84.6% (29.2%, 98.6%) 69.1% (31.7%, 91.5%) 53.7% (23.5%, 81.3%) 

Table 8. Estimated VA ENT endoscope reprocessing compliance with standard operating 

procedures and competence in accordance with VHA directive 2009-004 by supervisory 

staff. 

Competency Compliance With Both SOP Compliance Compliance SOP & Competence 

(95% Confidence Intervals) (95% Confidence Intervals) (95% Confidence Intervals) 

75.8% (45.0%,92.3%) 64.2% (38.6%,83.7%) 60.0% (33.6%,81.7%) 

Supervisory Staff 

Non-SPD 

(15 sampled 

reprocessing units: 

13 supervised by 

Nursing and 2 by 

ENT staff) 

SPD 

(22 sampled 

reprocessing units) 

77.6% (52.9%,91.5%) 49.1% (24.8%,73.9%) 39.8% (18.8%,65.3%) 

VA Office of Inspector General 31 
Use and Reprocessing of Flexible Fiberoptic Endoscopes at VA Medical Facilities 

Conclusions and Recommendations 

Facilities have not complied with management directives to ensure compliance with 

reprocessing of endoscopes, resulting in a risk of infectious disease to veterans. 

Reprocessing of endoscopes requires a standardized, monitored approach to ensure that 

these instruments are safe for use in patient care. 

The failure of medical facilities to comply on such a large scale with repeated alerts and 

directives suggests fundamental defects in organizational structure. 

The Clinical Risk Assessment Advisory Board has been an effective mechanism for 

providing guidance to VHA leadership on disclosure of adverse events to veterans. 

Recommendation 1. We recommend that the Acting Under Secretary for Health ensure 

compliance with relevant directives regarding endoscope reprocessing. 

Recommendation 2. We recommend that the Acting Under Secretary for Health explore 

possibilities for improving the reliability of endoscope reprocessing with VA and nonVA experts. 

Recommendation 3. We recommend that the Acting Under Secretary for Health review 

the VHA organizational structure and make the necessary changes to implement quality 

controls and ensure compliance with directives. 

VA Office of Inspector General 32 
 

 

Use and Reprocessing of Flexible Fiberoptic Endoscopes at VA Medical Facilities 

Appendix A 

CPT and ICD-9 Codes 

Gastrointestinal Endoscopy: Total
 

CPT: 43200-2, 43204-5, 43215-17, 43219-20, 43226-8, 43231-2, 43234-51, 43255-65,
 

43267-69, 43271-2, 44360-1, 44363-66, 44369-70, 44372-3, 44376-80, 44382-3, 44385-

6, 44388-44394, 44397, 45300, 45303, 45305, 45307-9, 45315, 45317, 45320-1, 45327, 

45330-5, 45337-42, 45345, 45355, 45378-87, 45391-2, 3130F, 3132F, 3140-1F. 

Gastrointestinal Endoscopy: Colonoscopy
 

CPT: 44388-44394, 44397, 45300, 45303, 45305, 45307-9, 45315, 45317, 45320-1,
 

45327, 45330-5, 45337-42, 45345, 45355, 45378-87, 45391-2. 

ICD-9: 45.23, 45.25, 45.41‐3
 

ENT Endoscopy
 

CPT: 31231, 31233, 31235, 31237-40, 31267, 31276, 31287-88, 31290-94, 31505,
 

31510, 31515, 31520, 31525-31, 31535-6, 31540-1, 31545-6, 31560-1, 31570-71, 31575-

9, 92511, S2342, S2344. 

ICD-9: 21.21, 22.11, 22.19, 29.11, 31.41-4. 

Cystoscopy
 

CPT: 52000-1, 52004-5,52007, 52010, 52214, 52224, 52235, 52240, 52250, 52260, 

52265, 52270, 52275-7, 52281-3, 52285, 52290-1, 52301, 52305, 52310, 52315, 52320, 

52325, 52327, 52330, 52332, 52334, 52341-6, 52351-5, 52400, 52402. 

Bronchoscopy
 

CPT: 31615, 31620, 31622-5, 31628-33, 31635-8, 31640-1, 31643, 31645-6, 31656. 

VA Office of Inspector General 33 
 

Use and Reprocessing of Flexible Fiberoptic Endoscopes at VA Medical Facilities 

Appendix B 

National Center for Patient Safety Review of 

Reprocessing Issues 

Endoscope Reprocessing Autopsy 

National Center for Patient Safety 

17 April 2009 

Purpose 

Identify vulnerabilities, especially systems-based vulnerabilities, in our processes related 

to flexible endoscope reprocessing. 

Background 

Organizations with well functioning safety programs are ones where staff are willing to 

report unsafe products and processes that could impact the safety and health of veterans. 

In VHA patient safety issues that are reported, found to be of high enough priority, are 

actionable, and found to have system implications are disseminated using the VHA 

Patient Safety Alert and Patient Safety Advisory process. As vulnerabilities are 

addressed through the Alert and Advisory process they often elicit additional reporting 

from the field on similar topics. It is important to note that more reports do not 

necessarily mean that more events are occurring. 

The first Patient Safety Advisory on reprocessing medical devices was issued March 6, 

2003, reaffirming to the facilities that the auxiliary water channel on Olympus 

EXERATM Gastrointestinal Endoscopes needed to be reprocessed (cleaned and highly 

disinfected, or sterilized) each time the endoscope was used. On February 13, 2004, a 

Patient Safety Alert was issued directing facilities to ensure that the correct connectors 

were being used when reprocessing Gastrointestinal Fiberoptic Endoscopes. Since 

February 13, 2004, there have been eleven additional VHA Patient Safety Alerts and 

Advisories issued on the topic of medical device and equipment reprocessing with the 

most recent issued on December 22, 2008 regarding endoscopes. 

Findings of Systemic Issues 

Based on NCPS site visits, meetings with manufacturers, and review of VHA data 

including over 24 Issue Briefs covering numerous facilities, NCPS has identified a 

variety of causes that underlie the improper reprocessing of flexible endoscopes. 

While any procedure can be improved to reduce ambiguity, the current manufacturers 

reprocessing instructions were not felt to be a significant vulnerability that required 

correction. Similarly, the design of the equipment was not thought to be the pivotal cause 

VA Office of Inspector General 34 
Use and Reprocessing of Flexible Fiberoptic Endoscopes at VA Medical Facilities 

National Center for Patient Safety Review of Reprocessing Issues 

of the problems that were encountered. This was discussed in detail with the FDA. 

However, NCPS is continuing to work with device manufacturers to improve their 

designs and reprocessing instructions as appropriate. 

Common system issues that have been identified across VHA are listed below. Several 

that have particular application to the direct causation of the current Miami situation but 

all are potentially applicable in a more general sense. 

o	 Oversight Issues. There is a lack of routine oversight of the medical 

product and device reprocessing process by Supply, Processing and 

Distribution (SPD), Infection Prevention and Control, and Quality 

Improvement staff. Periodic visits are not being conducted in all areas 

involved in reprocessing outside of the SPD area (i.e. pre-cleaning and post 

clinical procedures) to ensure that the approved SOPs are being followed. 

o	 Incongruous SOPs. Facility developed Standard Operating Procedures 

(SOPs) for endoscope reprocessing lacked device specific information or 

information of sufficient detail to facilitate staff meeting manufacturers 

reprocessing requirements. Departures from manufacturer’s instructions 

had been inappropriately based upon verbal input from sales 

representatives. No process has been established to periodically review and 

update SPD SOPs to confirm that they meet the manufacturer’s current 

instructions. 

o	 New Technologies. There is no mechanism or system in place to capture 

manufacturer equipment reprocessing instructions in the SOPs as new 

devices are introduced or as outdated equipment or expendables are 

replaced. 

o	 Adulteration of Equipment. GI scope auxiliary equipment was found to be 

adulterated at more than one facility. This was not a factor in the Miami 

event. Staff, both clinical and technical, demonstrated a lack of awareness 

that any change to medical equipment should be an exception and only 

undertaken by qualified individuals. 

o	 Facility Equipment Committee. SPD Service is generally not represented 

on the facility Equipment Committee (or its equivalent). This committee 

has a significant role in purchasing new devices and their associated single 

or multi-use expendable products and representation would permit SPD to 

VA Office of Inspector General 35 
Use and Reprocessing of Flexible Fiberoptic Endoscopes at VA Medical Facilities 

National Center for Patient Safety Review of Reprocessing Issues 

learn of new purchases and prepare reprocessing Standard Operating 

Procedures. 

o	 Communication. The lack of a daily dialog between staff in SPD and GI 

Lab staff reconciling the number of consumables (e.g., MAJ-855) to expect 

that day needing reprocessing. While both services may have access to the 

daily schedule, changes may occur due to missed appointments or emergent 

procedures, if SPD knows this information it will permit them to confirm 

that the correct number of MAJ-855s are received from GI and reprocessed. 

Such a process would provide a greater robustness through increased fault 

tolerance. 

o	 Competencies for GI Lab. Competencies for GI Lab (or other services 

involved in any aspect of reprocessing devices and equipment) and SPD 

staff assigned endoscope reprocessing duties do not contain specific 

requirements for the equipment being used. 

o	 Clinical staff knowledge. Clinical staff do not have any requirement to be 

familiar with and comply with manufactures instructions. In the Miami case 

the instructions to prime the flushing circuit prior to starting the procedure 

with the patient were frequently not followed. This failure to prime the 

flushing circuit together with not changing the MAJ-855 tubing for years, 

instead of between each patient, necessitated notifying thousands of 

patients about the potential risk of infection. 

o	 Organizational alignment. Currently the SPD function does not report to 

the same entity when comparing one VHA facility to another. This 

variability (e.g., nursing, surgery, logistics, pharmacy) makes it difficult to 

communicate clearly and consistently throughout the organization and in 

some cases establishes an inherent conflict of interest (working for the 

individuals who may be violating policy and procedure). This variability in 

organizational alignment when combined with inadequate Quality Control 

and Quality Improvement mechanisms virtually guarantees the lack of 

standardization on consistency of performance across VHA. 

o	 Quality Control Issues. Quality control is testing against standards and 

specifications with the objective to block the release of defective products. 

In the case of SPD processes this could include parameters such as time, 

temperature, and sterilant contact, to ensure that processes are operating 

within specified control limits. Quality control activities were found to be 

limited in scope; for example, in SPD quality control involved the number 

VA Office of Inspector General 36 
Use and Reprocessing of Flexible Fiberoptic Endoscopes at VA Medical Facilities 

National Center for Patient Safety Review of Reprocessing Issues 

of processed loads, load biological monitoring, sterilant chemical 

monitoring, and the number of rejects in SPD due to failed biological 

indicators. Of specific applicability with regard to Miami, as well as other 

facilities that have been identified, is the use of additional monitors such as 

the number of MAJ-855s being reprocessed vs. the number of scopes being 

reprocessed and the number of flushing fluid containers (7501352) being 

processed vs. the GI Lab daily schedule. 

o	 Quality Assurance Issues. Quality Assurance is improving and stabilizing 

processes through observation, assessment, and measurement so that 

defects don’t occur in the first place. With the notable exception of the 

clinical laboratories, health care employs minimal quality assurance 

processes. This is certainly the case with respect to the reprocessing and 

use of flexible endoscopes. These activities should include: oversight to 

ensure that appropriate, detailed, current SOPs that follow current 

manufacturer guidelines exist for all medical devices and products that are 

being reused; that SOPs are being implemented in all areas where 

reprocessing activities take place; that staff (both SPD and clinical) 

competencies are current; and monitors (e.g., the number of returns to SPD 

for reprocessing from the using service due to contamination) are in place. 

Summary/Conclusions 

There were numerous reports from facilities that identified failure to comply with 

manufacturers reprocessing instructions. The failure to follow the instructions 

stemmed from many significant factors but ambiguity of the manufacturer 

instruction themselves was not a factor. For example, virtually all facilities with 

identified problems did not change the MAJ-855 auxiliary water tube between 

each patient, a requirement that is mentioned multiple times in multiple places in 

the reprocessing instructions. Failure to comply with this instruction has its roots 

in a culture in medicine that does not always appreciate the need to adhere to the 

details of instruction and routinely tolerates or encourages personal preference 

based actions. When this is combined with a lack of organizational components 

that provide robust quality control and quality assurance mechanisms it is likely 

that less than perfect performance can result. 

Unlike many areas in healthcare where the expectation of 6 sigma performance is 

unrealistic due to the extreme variability among patients this constraint does not 

apply when it comes to the reprocessing of endoscopes. This is because the 

reprocessing of scopes is a hardware related activity that has discrete and well 

VA Office of Inspector General 37 
Use and Reprocessing of Flexible Fiberoptic Endoscopes at VA Medical Facilities 

National Center for Patient Safety Review of Reprocessing Issues 

characterized tasks. The analog for endoscope reliability would be commercial or 

military aviation maintenance. To achieve similar levels as in aviation, health care 

needs to use similar approaches to deal with the issues we have identified. This 

means that the organizational structure and appropriate quality control and 

assurance mechanisms, such as ones to address the vulnerabilities identified 

above, must be created and implemented. 

VA Office of Inspector General 38 
 

Use and Reprocessing of Flexible Fiberoptic Endoscopes at VA Medical Facilities 

Appendix C 

VHA Facilities Sampled for 

Unannounced Inspections* 

OHI did unannounced inspections of the following 42 VHA facilities: 

New Mexico VA Health Care System – Albuquerque, NM 

VA Gulf Coast Veterans Health Care System – Biloxi, MS 

Jesse Brown VA Medical Center – Chicago, IL 

Louis Stokes VA Medical Center – Cleveland, OH 

Wm. Jennings Bryan Dorn VA Medical Center – Columbia, SC 

VA North Texas Health Care System, Dallas VA Medical Center – Dallas, TX 

North Chicago VA Medical Center – North Chicago, IL 

VA New Jersey Health Care System, East Orange Campus – East Orange, NJ 

Fayetteville VA Medical Center – Fayetteville, NC 

Malcom Randall VA Medical Center, North Florida/South Georgia Veterans Health 

System – Gainesville, FL 

G.V. (Sonny) Montgomery VA Medical Center – Montgomery, AL 

Manchester VA Medical Center – Manchester, NH 

Jack C. Montgomery VA Medical Center – Muskogee, OK 

Southeast Louisiana Veterans Health Care System – New Orleans, LA 

VA Nebraska Western Iowa Health Care System – Omaha, NE 

VA Pittsburgh Healthcare System, University Drive Division – Pittsburgh, PA 

Northern Arizona VA Health Care System – Prescott, AZ 

VA Roseburg Healthcare System – Roseburg, OR 

Salem VA Medical Center – Salem, VA 

W.G. (Bill) Hefner VA Medical Center – Salisbury, NC 

San Francisco VA Medical Center – San Francisco, CA 

VA Puget Sound Health Care System – Seattle, WA 

Sheridan VA Medical Center – Sheridan, WY 

Overton Brooks VA Medical Center – Shreveport, LA 

South Texas Veterans Health Care System – San Antonio, TX 

Jonathan M. Wainwright Memorial VA Medical Center – Walla Walla, WA 

VA Greater Los Angeles Healthcare System – Los Angeles, CA 

VA Southern Oregon Rehabilitation Center & Clinics – White City, OR 

Wilkes-Barre VA Medical Center – Wilkes-Barre, PA 

Billings VA Outpatient Clinic – Billings, MT 

VA Gulf Coast Veterans Health Care System, Pensacola Outpatient Clinic – 

Pensacola, FL 

Lyons Campus of the VA New Jersey Health Care System – Lyons, NJ 

VA Office of Inspector General 39 
Use and Reprocessing of Flexible Fiberoptic Endoscopes at VA Medical Facilities 

VHA Facilities Sampled for Unannounced Inspections* 

James J. Howard VA Community Clinic – Brick, NJ 

Lake City VA Medical Center, North Florida/South Georgia Veterans Health System – 

Lake City, FL 

Jacksonville VA Outpatient Clinic – Jacksonville, FL 

VA Central Iowa Health Care System, Des Moines Division – Des Moines, IA 

Iowa City VA Medical Center – Iowa City, IA 

Winston-Salem VA Satellite Outpatient Clinic – Winston-Salem, NC 

Charlotte VA Outpatient Clinic – Charlotte, NC 

VA Puget Sound Health Care System, American Lake Division – Tacoma, WA 

Kerrville VA Medical Center – Kerrville, TX 

Sepulveda VA Ambulatory Care Center – North Hills, CA 

* The following facilities were excluded from selection for the unannounced onsite 

inspection: 

•	 Miami, Murfreesboro, Augusta, and their associated facilities, because separate 

detailed onsite inspections were conducted at there. 

•	 VA Maryland Healthcare System (Baltimore and Perry Point), where we 

conducted exploratory information gathering. 

•	 Alaska VA Healthcare System, because of its geographic distance. 

VA Office of Inspector General 40 
 

Use and Reprocessing of Flexible Fiberoptic Endoscopes at VA Medical Facilities 

Appendix D 

Acting Under Secretary for Health Comments 

Department of 

Veterans Affairs Memorandum 

Date:	 June 11, 2009 

From:	 Acting Under Secretary for Health (10) 

Subject: OIG Draft Report, Healthcare Inspection, Use and 

Reprocessing of Flexible Fiberoptic Endoscopes at VA 

Medical Facilities, Project No. 2009-01784-HI-0106 

(WebCIMS 432508) 

To:	 Assistant Inspector General for Healthcare Inspections (54) 

1. I have reviewed the draft report, and I concur with the recommendations 

and findings. Your report's conclusion that VHA facilities have not complied 

with management directives regarding the reprocessing of endoscopes, 

resulting in a risk of infectious disease to veterans, is an urgent 

management and clinical issue, and I am committed to making the 

necessary changes to correct this lack of compliance. 

2. As your report accurately states, despite repeated attempts to address 

this issue, VHA has had a persistent challenge with ensuring the reliability of 

endoscope reprocessing in our medical facilities. This is partly because 

reprocessing of reusable medical equipment has complex characteristics, as 

described in this report, that present a formidable challenge for all types of 

medical facilities, whether they be in the government or the private sector. 

However, I also realize that there are deficiencies specific to VHA that we 

need to target and address as an organization in order to ensure that 

instruments are safe for use in patient care. 

3. One of these specific requirements is the need for VHA to apply a 

standardized approach to ensure the reliability of endoscope reprocessing in 

all of our applicable facilities, and monitor the system to continuously ensure 

expected performance. In response to this need, VHA issued Directive 

2009-004, Use and Reprocessing of Reusable Medical Equipment (RME) in 

Veterans Health Administration Facilities on February 9, 2009, which 

VA Office of Inspector General 41 
Use and Reprocessing of Flexible Fiberoptic Endoscopes at VA Medical Facilities 

VHA Facilities Sampled for Unannounced Inspections* 

Page 2 

OIG Draft Report, Healthcare Inspection, Use and Reprocessing of Flexible 

Fiberoptic Endoscopes at VA Medical Facilities, Project No. 2009-01784-HI0106 (WebCIMS 432508) 

provides systematic guidance and policy for the set up, proper use, 

reprocessing, and maintenance of all RME used in VHA facilities. To 

ensure that facilities are compliant with and adhering to specific guidelines 

in this Directive, the Deputy Under Secretary for Health for Operations and 

Management (DUSHOM) recently required all VISN and Medical Center 

Directors to certify compliance by June 9, 2009. Furthermore, the DUSHOM 

is requiring that VISN staff conduct random site visits of facilities with the 

goal of visiting every facility that does any type of endoscopic procedure by 

July 31, 2009. The VISN Director must confirm completion of these site 

visits with the DUSHOM, along with any identified issues and a timeframe 

for resolution. 

4. Additional components that VHA will specifically evaluate and address 

include organizational structures and systems in order to ensure reusable 

medical equipment is reprocessed according to manufacturers’ instructions 

with high reliability, and to document facility compliance with recommended 

standard operating procedures as well as with implementation of 

appropriate responses to alerts and directives impacting reprocessing. VHA 

will take several measures to ensure this: 

a.	 VHA will implement systems to ensure that all individuals engaged in 

reprocessing reusable medical equipment will have device-specific 

competencies documented and demonstrated at a minimum on an 

annual basis. 

b. VHA will implement measures to ensure that device and procedure 

specific standard operating procedures (SOPs) are uniformly 

available, are updated as required, and are reviewed at least 

annually. 

c.	 VHA will coordinate the implementation of quality management 

systems and ensure that robust quality control is implemented and 

appropriately documented in all VHA facilities where reprocessing 

occurs. 

d. VHA will standardize equipment at the facility level where ever 

possible to ensure uniformity in the setup, use and reprocessing of 

equipment. 

e.	 VHA will negotiate national contracts to ensure standardization of 

equipment and leverage its ability to maximize added value from the 

vendors, including support of maintenance, repair and training. 

VA Office of Inspector General 42 
Use and Reprocessing of Flexible Fiberoptic Endoscopes at VA Medical Facilities 

VHA Facilities Sampled for Unannounced Inspections* 

Page 3 

OIG Draft Report, Healthcare Inspection, Use and Reprocessing of Flexible 

Fiberoptic Endoscopes at VA Medical Facilities, Project No. 2009-01784-HI0106 (WebCIMS 432508) 

5. Thank you for the opportunity to review the report and provide 

comments. Due to the short time allotted for reviewing this report, VHA will 

prepare its detailed plan of corrective action and present them to you at a 

later time. I would be pleased to discuss any concerns or comments you 

may have about this response. If you have any questions, please have a 

member of your staff contact Margaret Seleski, Director, Management 

Review Service (10B5) at (202) 461-8470. 

(original signed by:) 

Gerald M. Cross, MD, FAAFP 

VA Office of Inspector General 43 
 

Use and Reprocessing of Flexible Fiberoptic Endoscopes at VA Medical Facilities 

Appendix E 

OIG Contact and Staff Acknowledgments 

OIG Contacts Limin X. Clegg, PhD lin.clegg@va.gov 

Jerome E. Herbers, Jr., MD jerome.herbers@va.gov 

George B. Wesley, MD george.wesley@va.gov 

Acknowledgments 

Annette Acosta, FNP 

Daisy Arugay, MT (ASCP) 

Lisa Barnes, LMSW 

Gail Bozzelli, RN 

Verena Briley-Hudson, RN 

Shirley Carlile 

Paula Chapman, CTRS 

Patricia Christ, RN 

Victoria Coates, LICSW 

Melanie Cool, RD 

Sheila Cooley, GNP 

Linda DeLong, RN 

Donna Giroux, RN 

David Griffith, RN 

Deborah Howard, RN 

Cathleen King, RN 

Nathan McClafferty, MS 

Nelson Miranda, LMSW 

Karen Moore, RN 

Rayda Nadal, RN 

Roxanna Osegueda, MBA 

Glen Pickens, RN 

Jennifer Reed, RN 

Wilma Reyes, MD 

Prabu Selvam, MHA 

Kathleen Shimoda, RN 

Christa Sisterhen, 

CCC-SP 

Patrick Smith, MS 

Randall Snow, JD 

Virginia Solana, RN 

Yurong Tan, PhD 

Carol Torczon, ACNP 

Mary Toy, RN 

Toni Woodard 

Susan Zarter, RN 

VA Office of Inspector General 44 
 

Use and Reprocessing of Flexible Fiberoptic Endoscopes at VA Medical Facilities 

Appendix F 

Report Distribution 

VA Distribution 

Office of the Secretary 

Veterans Health Administration 

Assistant Secretaries 

General Counsel 

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. Senators: Bill Nelson, Mel Martinez, Lamar Alexander, Bob Corker, 

Saxby Chambliss, Johnny Isakson 

Representatives: Kendrick Meek, Ileana Ros-Lehtinen, Lincoln Daiz-Balart, 

Mario Daiz-Balart, Bart Gordon, Zach Wamp, Lincoln Davis, Jim Cooper, 

Paul Broun, Jr., John Barrow 

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

VA Office of Inspector General 45