Pointless visit: CMS inspected Las Vegas HCV outbreak clinic but missed unsafe needle practices
Agency now dramatically stepping up efforts in ambulatory care
Joseph Perz, PhD
Conducting an inspection in a Las Vegas endoscopy clinic shortly before it became the epicenter of the largest "look-back" patient testing effort in medical history, inspectors for the Centers for Medicare & Medicaid Services saw nothing amiss with needle practices that ultimately led to a nationally publicized hepatitis C outbreak, Hospital Infection Control & Prevention has learned.
"The clinic that was at the center of the outbreak in Nevada in fact had undergone a CMS certification survey in the summer before the outbreak came to light [in 2007], and around the same time — we realize now — that transmission was occurring," says Joseph Perz, PhD, acting team leader for prevention in the Centers for Disease Control and Prevention's division of health care quality promotion. "One of the things we realized in the context of the outbreak was that injection practices and other basic infection control was not something that was being examined as part of the standard survey process."
However, two senior CMS officials in Washington DC, who spoke to HIC on condition of anonymity, said the survey in June 7, 2007, was conducted in response to a complaint that was not related to infection control, and thus beyond the scope of the visit to the now closed Endoscopy Center of Southern Nevada. HIC subsequently learned there were actually three complaints, addressed in one inspection, but again, none was directly related to infection control. The complaints — which were not substantiated by the inspectors — included post-op bleeding, missed diagnosis, and prolonged waiting, according to CMS records.
In any case — despite a series of outbreaks in ambulatory care in recent years linked to improper injection practices — there still may be a tendency to take such basic infection control measures as a given. "I think it's true — not just for CMS, but other accrediting bodies and many of us across public health — that we tended to take safe injections a bit for granted because it is so basic," Perz says. "Sometimes, you wonder at what point does common sense end and infection control begin?" Still, the CDC and CMS decided to collaborate in an education and pilot survey program in part because the CDC "realized that [CMS surveyors] didn't feel comfortable assessing things like injection safety," he says.
The Las Vegas outbreak resulted in public health officials urging some 50,000 patients (roughly the population of Ames City, IA) to be tested for HCV, HIV, and hepatitis B. The practices under investigation in Nevada include alleged reuse of syringes and re-entry into single-dose vials of pain medication for different patients undergoing colonoscopies. As this issue went to press, nine HCV infections had been linked to the outbreak and another 77 are being investigated as possible cases.
"Improving the safety in outpatient settings is even more challenging than what we are facing in acute care hospitals," says Denise Cardo, MD, director of the CDC's division of health care quality promotion. "What we have seen in the outbreak investigations are things that should never be happening — like the reuse of syringes and using single-dose vials as multidose. We are working with CMS to improve the way these facilities are being inspected. We have been in several states with CMS surveyors to do the surveys and train them."
Indeed, — whether reacting to the survey incident or the Nevada outbreak in general — CMS is making several moves to beef up oversight of outpatient settings. While declining to comment on questions related to the specific incident, a CMS spokeswoman provided information abut the pilot survey program and the agency's expanding interest in ambulatory care.
"CMS worked with state and local authorities in Nevada to ensure that all 50 ambulatory surgical centers [ASC] in NV (which include colonoscopy clinics) had an on-site survey," Ellen B. Griffith, CMS spokeswoman, said in an e-mail. "CMS worked closely with the CDC to refine and apply infection control inspection tools in such surveys. CMS and the state survey agency cited deficiencies in a large proportion of the cases due to ASC lapses in infection control. In 2008, CMS also implemented a pilot program of expanded surveys for ASCs in three states, again working closely with the CDC to test improved protocols for reviewing ASC infection control practices. Results of that pilot will be available in early 2009."
The three states in the pilot study are Maryland, North Carolina, and Oklahoma. According to Griffith, the survey results should be useful in informing CMS action to improve patient safety, particularly in the following three areas:
1. Surveyor guidance: Identify areas where CMS guidance for surveyors ought to be expanded, clarified, or improved.
2. Targeting surveys: Expand methods by which CMS can best identify subsets of ASCs that most need survey attention.
3. Infection control:
a. Data: Assess the extent of infection control issues in ASCs.
b. Tool: Test the CDC infection control review tool and assess the extent to which key elements of the CDC tool might be advantageously used in the survey process;
c. Fiscal Impact: Assess the fiscal impact of using such a tool in an expanded survey.
In addition to the three-state pilot, the CMS has directed all states to do a targeted survey starting in October 2009 to obtain a 10% sample of "those ASCs that the states thought might most need survey & certification attention," Griffith says. Moreover, CMS recently announced that a final rule will appear in the Nov. 18, 2008, Federal Register detailing changes to the agency's outpatient ambulatory surgical center payment system.
"There is a discussion in the final rule of our plans to expand the hospital-acquired conditions concept to other health care settings (as health care-acquired conditions)." Griffith said. "Even before we develop payment policies in ambulatory settings that would deny payment for health care-acquired conditions, we are addressing the Nevada HCV outbreak through our survey and certification process. The hospital- or health care-acquired conditions policies affect Medicare's payment for services to individual patients. The survey and certification process looks at whether the health care facility is complying with licensing or accreditation standards. In most cases, CMS will work with a facility to develop an appropriate plan to correct a violation and bring the facility into compliance with standards; but if the facility is unwilling or unable to come into compliance, Medicare may revoke the facility's billing privileges."
Having certainly gotten the attention of hospitals by slashing reimbursement for certain infections, CMS could be the critical driver that has been lacking in improving infection control in ambulatory care. Indeed, with its control of the purse strings, CMS could exact considerable leverage on both freestanding and hospital-affiliated clinics of all stripes. The final rule includes several infection control requirements for ambulatory settings, but the issue of nonpayment still is under discussion.
"Although CMS is committed to strengthening the tie between payment and quality, we are still in the very early stages of deciding whether to address adverse health care events through our payment or coverage policies, and how to adapt the concept of the hospital-acquired conditions provisions, which are specific to the hospital Inpatient Prospective Payment System, to other types of services that are paid using other methodologies," Griffith said.
Part of the problem is obvious to any infection preventionist — an infection acquired in a clinic could easily go unreported in the absence of an outbreak. However, direct observation and enforcement of process measures via surveys should improve care quality. "The survey process can help but it's not an absolute guarantee of safety practice because there is variation among providers even within a given clinic or other facilities," Perz says. Nevertheless, another good sign is that the CDC and CMS now appear to be on the same page about infection control in ambulatory care.
"We are finding that by working more closely with CMS we can help ensure that infection control recommendations developed through CDC are included in things like 'conditions for coverage' for health care providers that take funding from CMS," Perz says. "Frankly, it's one way to get providers to pay attention — to have the payer point explicitly to those types of requirements. A good example of that is our work with CMS to include specific infection control recommendations for dialysis settings and the conditions for coverage for end-stage renal disease."
Indeed, the CDC recently announced that its 2001 infection control recommendations for dialysis have been codified into CMS regulations. "It is quite specific, and we call special attention to handling of potential medications and, in particular, the use of single-dose vials in dialysis settings," Perz says. "There was a parallel in Nevada where medications that are actually not approved as multidose vials were being used as if they were multidose vials. It's a problem we are becoming more and more aware of."
CDC admits own mistake
However, in doing so, the CDC had to somewhat awkwardly concede that it may have been part of the problem in dialysis, as the agency clarified that a 2002 CDC communication to CMS "suggested that reentry into single-use parenteral medication vials (i.e., to administer medication to more than one patient), when performed on a limited basis and under strict conditions in hemodialysis settings, likely would result in low risk for bacterial infection. However, the 2002 communication did not address risks for bloodborne viral infections (e.g., HCV and hepatitis B virus infection). This report is intended to clarify and restate CDC's recommendation on parenteral medication to include bloodborne viral infections. The recommendations in this report supersede the 2002 CDC communication to CMS."1
In other words, the practice of reusing single-dose vials for multiple draws is officially banned, particularly in the considerable wake of the Vegas outbreak. "There was a [CDC] communication that, in the end, was picked up widely in the dialysis community as offering a recipe for how to use these single-dose vials for multiple draws, so we wanted to be clear that that was off the table," Perz says. "We had seen it misapplied, misinterpreted, and we had seen continued transmission where drugs like erythropoietin were suspected in having a role in infections like HCV. In the time since that original communication, there was accumulating evidence that it was not a safe practice."
In a related development, the CDC is working with industry to see if there are opportunities to improve medical devices and medication packaging to reduce reuse and cross-contamination of injection equipment and vials, he added. "That includes injection equipment and other devices to access, transfer, or administer parenteral medications — as well as labeling improvements and economical 'right-sized' containers," Perz notes.
Despite such progress on varied fronts, broad improvement of infection prevention in ambulatory care remains a work in progress. But the Nevada outbreak and the growing involvement of CMS suggest the inertia is finally giving way to movement. Nevada also is expected to consider a state law next year that will include periodic inspections by infection prevention consultants. Such model legislation and other requirements could create a potential business boom in IP consulting if regulation is widely applied in outpatient settings.
"We are acknowledging the shift in care and trying to make sure that basic safe care practices are understood by providers wherever they are practicing," Perz says. "CDC continues to be [called in] on outbreaks and incidents that involve unsafe injections. Nevada was certainly the most notable example — maybe of all time. But unfortunately, it is just one in a steady stream of such incidents. We are contacted on a regular basis where unsafe handling of injectable medications is either suspected or shown to be the cause of infections. And not just hepatitis by the way, but bacterial infections as well."
In addition to CMS involvement, accreditation, medical licensing and staff training issues all have to be addressed to improve the situation, Cardo says. "The good news is that because of Nevada everyone is paying attention," she says. "We are receiving calls and the involvement of consumers is extremely important. They are pushing for action not just at the local level but also at the federal level. That can help us move forward in a faster way."
- Centers for Disease Control and Prevention. Infection control requirements for dialysis facilities and clarification regarding guidance on parenteral medication vials. MMWR 2008; 57(32):875-876.