HHS hits pause button — and a few nerves — on injection safety issues in ambulatory care

'We won't get an opportunity to continue to define the scope of the problem.'

By Gary Evans, Executive Editor

Marcia Patrick, RN, MSN, CICThe Department of Health and Human Services (HHS) appears to be taking a step back from its recent emphasis on injection safety issues in ambulatory care and surgical settings (ASCs), though noting that some 3,200 inspections done in fiscal years 2010 and 2011 "found that deficient infection control practices are widespread in ASCs," according to a report by the Government Accountability Office (GAO).

There has been some confusion about whether the HHS is relegating infection control in ambulatory care to a lower priority or has simply gathered enough data for analysis and planned interventions. In any case, the Association for Professionals in Infection Control and Epidemiology (APIC) immediately expressed disappointment in the decision.

"APIC is not happy with it, but the [key] detail is it's not that they are going to stop surveying for injection safety and other infection control things — they are going to stop aggregating the data and publishing it," says Marcia Patrick, RN, MSN, CIC, a member of the APIC board of directors. "That means we won't get an opportunity to continue to define the scope of the problem. One would hope that after the surveys that we should see a decrease in the number of violations for these things, but we are not going to know — other than anecdotally — if the surveyors say it is getting better, it is getting worse, it's not changing. That's not scientific."

U.S. Rep. Frank Pallone, Jr. (D-NJ), requested the GAO report in September 2011 to help Congress identify gaps in current health care practices and improve patient safety while reducing costs. While citing lean budgets of state survey agencies in changing the program, the HHS put something of a positive spin on the action by noting that it had collected several thousand of the survey worksheets and had sufficient data for analysis of infection control practices in ambulatory care.

"[This action] prevents us from continuing to explicate the scope of the problem," Patrick says. "What other things are being identified that could help us devise solutions? How are we going to be able to provide solutions if we don't know what the problems are?"

Deficient practices not described

The deficient practices uncovered thus far were not specifically described in the GAO report. The HHS referred inquiries about them back to its written statement included as an appendix in the GAO report. The HHS stated that the outpatient settings have been "required to correct these deficient practices," which were detected in a survey program that began after the 2008 outbreak of hepatitis C virus in a Las Vegas endoscopy clinic. That highly publicized outbreak — which resulted in nine cases of confirmed HCV transmission to patients and another 100 people that were possibly infected in the now-shuttered clinic — resulted in a partnership between two HHS agencies, the Centers for Disease Control and Prevention (CDC) and the Centers for Medicare and Medicaid Services (CMS). The CDC developed an infection control worksheet that the CMS began using to survey injection safety and other infection control measures in the ambulatory settings, many of which are not accredited by the Joint Commission and have heretofore operated well under the radar.

In the Las Vegas outbreak, improper use of single dose vials on more than one patient and other violations of basic infection control were implicated. While shocking at the time, such practices may remain a temptation given current shortages of certain drugs and the lack of vials small enough to be truly sufficient for one patient only. Even apparently meticulous, good-faith efforts to preserve medication that should be discarded from single dose vials is a high-risk venture. Such practices can still result in outbreaks, as seen most recently in severe bacterial infections with methicillin-resistant Staphylococcus aureus (MRSA) in two pain clinics.

"The CDC has reiterated its position — single-dose vials means single use because we keep seeing these devastating outbreaks," Patrick says. "You give somebody hepatitis B and there is something like a 6% to 10% risk of becoming a lifelong carrier with a huge increase in risk for liver cancer. And for hepatitis C, probably 80% of the people that get infection end up with chronic carriage — they never get rid of the hepatitis. Hepatitis is the leading reason for liver transplants, so this is serious, life-changing stuff. It is all about patient safety. The risk to patients, I believe, is too great to not be doing everything we can to fully define [this problem] and then develop solutions."

As part of implementing the expanded oversight of ambulatory care after the Las Vegas outbreak, CMS collected detailed information from its Infection Control Surveyor Worksheets for fiscal years 2010 and 2011.

"Specifically for these two fiscal years, CMS required state surveyors to submit a completed copy of the worksheet for every ASC that they surveyed, in addition to their routine reporting of citations for lack of compliance with particular standards," the GAO reported. "According to the CMS officials, the agency plans to use the data collected from the surveyor worksheets to determine the differences in the type and level of citations given by state survey agencies to ASCs identified as noncompliant with the agency's health and safety standards. CMS officials said that the agency has provided CDC with the surveyor worksheet data to examine the extent of infection control problems, including unsafe injection practices, in a sample of ASCs nationwide, from which CDC officials expect to create a baseline assessment of unsafe injection practices in these settings. [The CDC expects] that it will be completed at some point in 2012."

The CMS stopped collecting individual worksheets from state survey agencies for each ambulatory care survey conducted after FY 2011, the HHS said in the GAO report.

"With over 3,000 worksheets collected, we believe there is sufficient data to support detailed analysis of ASC infection control practices nationally," the HHS said. "CMS was also interested in relieving the state survey agencies, which are operating in a resource-constrained environment, of the burden associated with preparing a consolidated worksheet and submitting it to our contractor after each ASC survey. In its recommendation, GAO has been sensitive to CMS's concerns about the burden on state survey agencies, suggesting that CMS could limit this data collection to a random sample of ASCs, adjusting the sample size, and collecting the data less frequently than every year. Consistent with these GAO suggestions, CMS plans to resume collection of the Infection Control Surveyor Worksheet beginning in FY 2013 for a state-stratified, randomly selected subset of ASCs surveyed in that year, and will repeat this sampling and data collection approximately every three years thereafter."

Asked whether collecting and analyzing surveys from a randomized subset less frequently would be sufficient to address the continuing problem, Patrick said, "It's more of a sampling size. And how do we know that this sampling size is going to be truly representative of what is really going on? I think we are early enough in this process that we need as much data as we can [collect] over time. Also, we need to see improvement, see where the gaps remain and then address those. Once we have a stable process then I think we look at some sampling."

Are surgery centers getting a bad rap?

The GAO report also did sit well with the Ambulatory Surgery Center Association (ASCA), which felt its facilities were being tarred with the same brush being swept over every strip-mall clinic and medical office in the country.

"The report makes a number of confusing leaps when discussing 'ambulatory care settings' and 'ambulatory surgery centers' that do a disservice to ASCs and merit correction," the ASCA said in a statement posted on its website. "We plan to meet with Representative Pallone's staff to discuss our concerns."

Bill Prentice, JDThe association further clarified that ambulatory surgery centers are not "rural health clinics, urgent care centers or ambulatory care centers that provide diagnostic or primary health care services. ASCs treat only patients who have already seen a health care provider and selected surgery as the appropriate treatment for their condition. ASCs are not physicians' offices either. All ASCs must have at least one dedicated operating room and the equipment needed to perform surgery safely and ensure quality patient care."

Noting that the GAO report seems to repeatedly lump all manner of outpatient settings as ASCs, Bill Prentice JD, CEO of the ASCA says, "We think the report is more than a little confusing in that regard and might mislead policy makers about where they need to devote attention to reduce infections. It seems like they want to keep drawing attention to the ASC setting — maybe because we are regulated by the CMS and these other settings [are not]."

Though the HHS subsequently agreed to the GAOs proposal to reduce the sample size and go to random selection, the GAO originally expressed concern that "without continuing to collect the data from the Infection Control Surveyor Worksheets after fiscal year 2011, CMS will lose its capacity to monitor ASC compliance specifically with respect to safe injection practices, which would be necessary to track the effectiveness of its increased efforts to prevent unsafe practices. CMS officials reported that they do not have access to information that would allow them to identify which citations stem in whole or in part from unsafe injection practices because the citation reports that are routinely submitted by surveyors after an ASC is inspected are based on standards that cover a mix of injection-related and other infection control or medication administration practices. Furthermore, the lack of the worksheet data will reduce CMS's ability to check the accuracy and completeness of surveyor assessments of unsafe injection practices going forward."

ASCs seek clarification on single-dose/single use

Drug shortage, vial sizes put ASCs in a bind

While emphasizing they are following all infection control guidelines, ambulatory surgery centers are lobbying public health officials to reconsider and clarify policies on single-use vials in light of current drug shortages.

"There is a larger issue of the problem that drug shortages are causing," says Bill Prentice, JD, chief executive officer of the Ambulatory Surgery Center Association. "I have heard from centers that have had to turn patients away and say, 'I'm sorry we can't treat you today because we do not have the drugs to safely perform your surgery.'"

Moreover, some of the scarce drugs are shipped in vials labeled single-dose, though they may contain more medication than needed for one patient.

"We are experiencing a lot of drug shortages on some of the major anesthetic drugs in particular that are used in ASCs," he says. "I'm hearing from our members that because of the packaging and size of these vials that they end up using a small amount of the injectable and then throwing the remainder away — which is a complete waste to the health care system."

Prentice and colleagues recently sought clarification on the issue in a meeting with officials from the Centers for Disease Control and Prevention. The question was essentially is there any process "that would allow a center to use a single-use vial on more than one patient in some aseptic way?" Prentice says. "Not reusing the needle — not reusing the syringe. We wanted to ask that question as well as find out what is the science behind their current protocols regarding single use."

The CDC recently reiterated its stance on the issue in light of continuing outbreaks, emphasizing that some centers were using appropriate drug substitutes or having pharmacies that adhere to the strict standards in United States Pharmacopeia General Chapter 797 safely split doses from single dose vials. That is not a practical solution for ASCs, which do not have pharmacists on staff because they use drugs for patient care and are not set up to dispense them, Prentice says.

"The drugs that are used in ASCs are primarily anesthetic pain control and things of that nature that are used while on site," he says. "To use a compounding pharmacy is not a practical solution. For example, there are no compounding pharmacies in Wyoming."

Moreover, even if ASCs incurred the expense of pharmaceutical drug compounding, the vials would have a very short shelf life, Prentice and colleagues told the CDC.

"It was a very productive meeting and the CDC staff pledged to continue to work with us on the issues," he says. "We are telling our members to be in full compliance with current best practices, which include using a single-use vial only once and then discarding the rest. That said, we are hearing a lot of pushback from our members who are really complaining about having to throw away perfectly good drugs."

The next steps are to meet with the Food and Drug Administration and possibly the drug manufacturing companies to seek redress on the issue, he said. "To have something labeled a single dose vial that holds 200 ml and the surgeon only needs 12 ml — then have to throw out the rest — doesn't make a lot of sense," he says.