A report revealing the extent of problems from the VA Office of the Inspector General was discussed during a hearing of the House Veterans Affairs Subcommittee on Oversight and Investigation on July 16, 2009.

Congress member Steven Buyer, Ranking Member of the House Committee on Veterans Affairs, who requested the meeting to review the report said:

I asked for the InspectorGeneral to become involved after the Miami incident, because I suspected the problem was systemic. Now that we know it is, I am deeply concerned that this problem is expansive and it goes well beyond VA. What is happening at HHS and the Department of Defense? What is happening in our greater health system?

On May 13, 2009, VA inspectors made visits to 42 randomly selected VA medical facilities that performed colonoscopies or ear, nose, and throat (ENT) endoscopies. Reporting on the 38 visited facilities that did colonoscopies, the inspectors found:

• 82 percent had locally-developed standard operating procedures based on manufacturers cleaning and maintenance manuals easily accessible for employees to use.
• 53 percent had records of employee training and skills with proper set-up and cleaning procedures
• 47 percent had both SOPs and competence documentation

The Inspector General’s Report said,

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.

Manufacturers provide instructions for maintaining and cleaning equipment, and often they train staff in how to clean endoscopes when they are first purchased. However, as staff turn over, facilities need to have training and supervision in place to be sure that new staff understand the procedures and all staff follow them.

March 8-14, 2009 was a system-wide Endoscopy Set-Up Week for all VA medical facilities that do colonoscopies.  During that week, facilities were required  to make sure that the following were in place:

• locally developed standard operating procedures for setting up and cleaning every device used based on manufacturers recommendations
• evaluations of model-specific competence for employees who set up or clean endoscopy equipment
• assured accountability for set-up and cleaning procedures in all areas and at all levels of the organization

The random inspections were conducted on May 13, 2009, two months after Set-Up Week.

Since endoscopes are reused and not thrown away and since they cannot be sterilized like some other surgical equipment, they must be carefully cleaned and sanitized after every patient use.

The Inspector General’s Report points out five key steps in decontaminating endoscopes:

• Pre-cleaning and scrubbing to remove all debris and body fluids from inside and outside surfaces. This is typically done by a nurse or technician right after the procedure.
• Disinfection by soaking the instruments in a disinfectant solution that is able to reach all areas of the equipment.
• Rinsing all surfaces with sterile, filtered, or high-quality drinking water to remove disinfectant.
• Flushing channels with alcohol to dry them, followed by forced-air drying.
• Storage in well-ventilated dry spaces, hung according to manufacturer’s recommendations.

From October 1, 2008 through May 23, 2009, nearly 200,000 gastrointestinal endoscopies were  performed in VA facilities, 142,500 of them colonoscopies.

According to the Miami VA, this creates a small risk of infection with viruses Hepatitis B, Hepatitis C, or HIV (Human Immunodeficiency Virus).  Therefore, they are:

• Notifying patients who had endoscopies between May 2005 and March 12, 2009 of the risk for infection.
• Establishing a Special Care Call Center at (305) 575-7256 or 1-877-575-7256
  where patients can call with questions or to schedule an appointment for hepatitis or HIV blood testing.
• Opening Special Care Clinics for follow-up care and testing for potentially affected patients Miami VA Medical Center, the Broward County VA Clinic, the Homestead VA Clinic and the Key West VA Clinic.

The Miami VA Healthcare System emphasizes that follow-up testing is only a precaution and that they know of no patients who have acquired an infection after endoscopy performed during the targeted dates.  There is no cost or co-pay for testing, and patients are eligible for transportation assistance.

Tubing is attached to the endoscope to carry water to clean the scope lens so that doctors can see the inside of the colon more clearly.  There is a small risk that infected material might splash back into the tubing and contaminate it.  The manufacturer recommends both rinsing and disinfecting the tubing after each procedure.

Miami VA Healthcare Systems Director Mary D. Berrocal says,

Miami VA emphasizes that screening is strictly precautionary and does not indicate that any patients have contracted a virus.  Although there is minimal risk, we feel that even a slight risk is unacceptable to the Veterans we care for.

If you are a veteran who had a colonoscopy or endoscopy performed in the Miami VA Healthcare System, you can get more answers to your questions online or you can call the Special Care Call Center at (305) 575-7256 or 1-877-575-7256.

Another 6,000 patients in the Tennesee Valley VA Healthcare System were notified of risk of infection due to a colonoscope valve connected incorrectly at a VA facility in Murfreesboro, TN.  Patients who had colonoscopies at the Alvin C. York campus between April 23, 2003 and December 1, 2008 were told to schedule blood testing as a precaution.

The Society of Gastroenterology Nurses and Associates has developed very precise and detailed guidelines for cleaning and disinfecting endoscopy equipment to prevent infection.

The American Society for Gastrointestinal Oncology estimates that there is no more than one infection in every one million, three hundred thousand endoscopy procedures.  Since their guidelines for high-level disinfection (HLD) went into effect in 2003, there have been no reports of infection when the guideline HLD procedures were followed.

Additional coverage of the situations in Miami and Mursfreesboro is available from MedPage Today, March 26, 2009.