By Cheryl Clark
Lisa McGiffert led Consumer Reports’ Safe Patient Project for 15 years, and after 27 years with the advocacy arm of the organization, she retired last year. But she has not taken off her patient advocacy hat. Not by a long shot.
She’s recently co-founded a nonprofit coalition called the Patient Safety Action Network (PSAN), to continue her work at CR, which she said is no longer focused on patient safety.
Though a young organization, PSAN is growing as a coalition that includes individuals and other organizations focused on medical harm, such as Breast Implant Victim Advocacy and Washington Advocates for Patient Safety. It received its nonprofit status in August.
PSAN’s more than 100 members — all volunteers — monitor licensing agencies and regulatory boards at state and national levels, and serve on FDA advisory boards, Agency for Health Care Research and Quality committees, state health provider licensing boards and National Quality Forum measure development panels. McGiffert hopes the organization can recruit at least one strong patient activist in every state.
PSAN also has taken over the ProPublica Patient Harm Community Facebook group.
She spent several hours talking with me about the trajectory of patient safety as an issue over time, from working on Health Policy during the Clinton administration to today’s pushback on patient protection progress made with the Affordable Care Act. Despite major gains in awareness and prevention policies and practices, there’s still a lot more to be done. She’ll explain, with lots of tips for story topics she hopes we will write.
Q: You’ve now started a new organization to take on some of the role that Consumer Report’s Safe Patient Project had focused on. Why did CR stop that project?
McGiffert: We had a change in leadership. Health was a major issue for our previous president and the organization spent about 15 years really focusing advocacy resources on health with the passage of the ACA and patient safety. I think they wanted to put more resources on other issues. The organization now focuses on food safety and privacy, including internet and health privacy, and are doing more advocacy around cars. Consumer Reports still covers health but doesn’t have a big advocacy staff for policy work.
Q: How did you get started in patient safety? Did you have a personal experience?
McGiffert: I did not. My patient safety radar began when I worked for the Texas Senate Health and Human Services committee for seven years starting in 1984, and was very involved in the oversight of medical boards and hospitals, including the implementation of the law that created the National Practitioner Data Bank, because every state had to implement laws related to that. I saw how the health care system worked, and was involved in many negotiations that led me to understand the imbalance of power. Rarely was there someone representing patients in the room.
I tip my hat to the people in Texas who pushed for rights for people with disabilities. They taught me how to be an activist. People were put in nursing homes who didn’t want to be there, because back then, the standard was that somebody with a serious disability had to live in a nursing home in order to get public support for their care. They wanted to be active partners in deciding where they lived and who cared for them.
Q: Wait, what? If you were disabled in Texas and a Medicaid beneficiary, you could only get supportive care if you were in a nursing home?
McGiffert: Pretty much. That was the way it was back then. The activists stormed the Texas Capitol and took over the governor’s office and got arrested. They were out there. All of that influenced me.
After joining CR, I worked on health access during the Clinton Health Policy push and started my work on healthcare quality. We worked to create an agency to collect hospital billing data, analyze the data and put out reports for the public. This was backed by large self-funded employers who wanted to know which hospitals to contract with, based on their safety record. It was a big expense for them so they wanted the most efficient and safest care. Data revealing why people went into hospitals and their outcomes helped to determine that.
Around 2003, when Jim Guest became the new president of Consumer Reports, he wanted the organization’s advocacy work to be more campaign-like – recruit people from across the country to help support consumer-oriented changes in the laws. Several proposals were put forward and mine was to create a model law for states to require hospitals to report their infection rates. My proposal was among those chosen, and we created a campaign called Stop Hospital Infections, later expanded and renamed as the Safe Patient Project. CR eventually built a list of a million people who might send emails to their legislators asking to support various legislation proposed by CU, including this bill. It was a big success, with more than 30 states adopting infection reporting laws.
Eventually, CMS, the Centers for Medicare & Medicaid Services, included infections in its program that paid hospitals to report, rather, if they didn’t report they wouldn’t get annual increases in their reimbursement. It is not exactly “required” but the incentive is enough that hospitals report this and other quality measures.
And that design is in danger today because CMS could stop that policy any day. Currently, some states with reporting laws require hospitals to report on more infections than CMS requires, and some require less. As an example, CMS only requires surgical site infection reporting for colon surgery and abdominal hysterectomies, but California law requires reporting on virtually all surgical site infections. They provide the most data in the US through a data portal and a web-based map where you can look up the rates.
Recently, numerous states have changed their laws to only report what CMS requires, so if the CMS program goes away, there’s a question in my mind whether the state requirements will go away. Texas just passed a law earlier this year, and I completely missed it. Washington state recently changed its law. They reported on hip and knee replacements, which we felt was very valuable and we fought with local advocates to keep this reporting. We won that, but only temporarily and it is now sunsetted. So it’s a constant battle to keep this information available to the public.
I don’t think there’s a lot of active work at the agency level to educate the public about what types of infections are showing up, but they do actually have the information in their public reports.
I learned early on in my career that secrecy is a major component in making the health care system less accountable to the public. The biggest challenge for patient safety is to stay on top of it. Even when something gets done, it’s never done because the next year the industry, the hospitals, the medical device makers come in and try to erode any kind of progress made on the patients’ behalf. And they have so many more resources than us, with lobbyists and staff people who are watching these issues all over the country, every day.
Q: Sometimes, though, the data doesn’t tell the truth. For example, it may seem like a hospital improved when all it did was do a better job at coding patients who came in with an infection, so that would be subtracted from the number of those who acquired an infection in the hospital. And we’ve heard that some hospitals play games with that.
McGiffert: Unfortunately, some hospitals lie. And some manipulate data in a way that can call it into question. But the big question is, what do we do to create appropriate checks and balances. How do we hold hospitals accountable for the information they provide? We need audits built in. CMS does “audits,” but they are so spotty that it’s difficult to identify problems. There are people who analyze the data who are knowledgeable and can see where the inaccuracies are.
We also need patient input, which I feel is a missing link. For example, if I have an adverse reaction or event with a medical device, I can go online and report that to the FDA (U.S. Food and Drug Administration) and it goes into a system where anyone can see what has been reported on that device. It’s a bit messy to search, not perfect, but we don’t have anything like this for infections or medical errors or surgery complications. Practically nothing. That kind of reporting, from patients and health care providers, could add important information about medical harm.
In California, hospitals are required by law to report certain medical errors, but they don’t always do it. Also, the state can fine hospitals for immediate jeopardies to patients. So, if a patient complains about a medical error that’s on the California list, and the hospital hasn’t reported it, and the state finds out it did happen, they can fine that hospital $100 per day, even years later. We need that kind of accountability system throughout the country.
Another accountability failure happens when a doctor has harmed a patient, gets dismissed from a hospital but gets a job someplace else, or moves to another state, after being disciplined. If the new state or hospital isn’t diligent in researching the doctor’s history, a dangerous doctor could be right back in business. There are systems in place where medical boards can look that kind of thing up, but they don’t. Furthermore, most doctors who are on probation continue practicing and their patients are not informed about it.
Q: There’s something called the Interstate Medical Licensure Compact, which is supposed to share information about doctors so doctors can practice in multiple states.
McGiffert: I think we need to watch it very carefully. It was created by physicians, and did not involve patients, and is a way to make it easier for doctors to get licenses in multiple states. It is supposed to have checks and balances for doctors who are “state shopping” to avoid discipline, but it has not been a public process. It makes sense for smaller states that are close together on the east coast, but could lead to confusing oversight of physician practices. This would be a good thing for a reporter to look at.
Q. Let’s talk about the Supreme Court decision regarding the North Carolina Board of Dental Examiners, the famous “tooth whitening” case, which has now put pressure on licensing boards to include public members lest their decisions be accused of restraint of trade. That decision said that when the majority of decision makers work in the same profession as those they license, i.e. most members of a physician licensing board are physicians, they may not have immunity from litigation from unhappy licensees or others, unless the state government actively supervises those decisions, which most state governments do not.
McGiffert: Every regulatory body should have a majority of people representing the public interest, as opposed to the industry being regulated. A major goal of PSAN, as with the Safe Patient Project, is to make sure patient activists are in the room. And not just patients who have their own stories and experience, but people who are knowledgeable about the system. They’ve learned from their own case what’s wrong with the system and want to help others. These tend to provide more meaningful input that those driven only by their own case or someone from the general public. PSAN members serve on state medical boards, FDA advisory committees and committees of national organizations such as the National Quality Forum.
Sometimes we have to advocate our way onto committees. For example, a national group of public health epidemiologists working to improve responses to infection outbreaks (CORHA – Council for Outbreak Response: Healthcare-Associated Infections and Antimicrobial-Resistant Pathogens) had been meeting for several years when they made a presentation to the Center for Disease Control and Prevention’s HICPAC (Healthcare Infection Control Practices Advisory Committee), for which I was a CR liaison. The project was funded by CDC.
I asked if they had any patient representatives in this group —they did not— and then to consider adding patient advocates. After about a year of discussion, including phone calls with other advocates, I was invited to join a workgroup developing guidelines for notifying patients and public disclosure about outbreaks. I know my participation has shifted their thinking. For example, if a patient got an infection connected with an outbreak, it isn’t standard to inform them. When I suggested that they would never withhold information from a patient diagnosed with cancer, it made them think about how inappropriate the secrecy around this issue is. They are very thoughtful people, but they’re dealing with a new crisis every day, another infection they have to track down. They are so focused on the process, finding the source, that they rarely stop to think about the patients’ need to know. I am very hopeful that this group will come out with clear guidelines that will lead to more transparency around outbreaks.
Q: How about money. Who is funding PSAN? Do you have any big donors?
McGiffert: No. We just got our nonprofit status in July and need to recruit a development expert. We plan to do fundraising for specific activities, such as helping our members attend meetings and maintaining a website. But many large donors typically want consumer and public interest groups to work with industry on projects they fund. There is nothing wrong with that – patients and health care industry reps need to work together, but generally, it becomes a distraction from our goals because patient advocates end up working on their agenda rather than ours.
Q: Health journalists often get calls from patients who want us to write their story of how a doctor or hospital or someone medically harmed them. They often aren’t sophisticated enough to know what records to ask for or have the money to spend to get them copied. They just know a mistake was made. Sometimes their condition prevents them from understanding what happened to them in a way a reporter must necessarily document. They tend to ramble. How would you advise journalists to get those stories without wasting time?
McGiffert: It is tricky. Patients often have trouble getting their records, and when they do, sometimes the information about harm is not even included. I’ve met many people who perseverate on the same thing, and never move beyond that. But I’ve also worked with many who then to go the next step. They dig forever and go to the next level of seeking accountability. It can be years before they put the pieces together. As a patient advocate, a consumer activist, when I make a statement, I better damn well have facts backing me up because some elected official or journalist is going to ask me where that came from. But doctors are rarely asked for evidence to back up their statements. I think verification should be the responsibility on all sides, not just patients.
I also tell patients to file complaints with state and federal regulators, even though most of the time nothing is going to happen. It helps to establish an official record, because everyone they speak to will ask them whether they did so and they will have a report they can provide as evidence. I told this to a group of advocates from an underserved community in Washington D.C. years ago and they looked at me incredulously. They asked, “Why would we recommend that if nothing’s going to happen? Why would we waste our time or risk our reputation with the people we work with?” There’s a widespread feeling among harmed patients that if their complaints just go into a black hole, it is not worth doing. I disagree and think it has value.
Q: We’re approaching the 20th anniversary of the landmark report from the Institute of Medicine, To Err Is Human, which was first published in November 1999. How far have we come? What progress has been made and what more still needs to be done?
McGiffert: We’ve come very far in public awareness and provider awareness of medical harm and its preventability, although there are still skeptics who think these events aren’t preventable. When I first started with the CR campaign for public reporting, that was the thinking: infections aren’t preventable. There’s been a real shift, with many embracing a goal of zero infections. We know many infections have been prevented, but we are still too far from zero. The patient voices around many tables have made a big difference. Many hospitals are creating patient and family councils to give them feedback on policies. Some hospitals really take their input seriously while others may give them kind of perfunctory attention. I always say hospitals should put their biggest critics on these committees and find out what the problems are.
We still lack information and reporting about medical errors. We need more local use of the data, to translate it at a city or state level where consumers are more likely to seek information. And we should be doing something to improve billing data, which keeps track of what happens to patients in hospitals. The hospitals claim the data isn’t accurate. It’s not okay that the record of my encounter at the hospital is so wildly inaccurate that it can’t be used to assess quality. Hospitals should be held accountable for accurate records.
Q: What other stories would you suggest reporters pursue?
McGiffert: The way CDC risk adjusts their infection rates (SIRs or standardized infection ratios) for public reporting unnecessarily skews their reports. For example, the CDC adjusts the MRSA SIR based on the rate of MRSA in the community, which should have no bearing on whether or not you get infected in a hospital.
The impact is that we may not get a clear comparison of hospital infection rates – two similar hospitals may have the same number of infections but if one has a higher rate of community MRSA, its SIR will be lower. Personally, I don’t think there should be adjustments. Health consumers want to know their risk for getting infections while in the hospital. These adjustments are a bigger problem in my opinion than the hospitals possibly lying.
Another problem is that CDC/CMS do not include the denominator with other data. So, you know how many people were infected but you don’t know how many were at risk for a particular infection. For example, we don’t know how many people had colon surgery, we only know the number of infections from that procedure. You need a denominator to figure out a ratio and the only ratio we have is the one CDC calculates with adjustments.
We really need to make accreditation reports for hospitals and other facilities publicly available. CMS has proposed this in the past but pulled back because the law needs to be changed. Keeping these reports secret withholds important information about the safety of hospitals.
Make use of the data available, for example, the FDA’s MAUDE database for medical device adverse events. It’s downloadable and can be searched. Madris Tomes is an activist who runs Device Events that has helped advocates for breast implant safety and the Essure birth control device. She has been able to create a database that reveals more from this FDA data than the FDA MAUDE system does. ICIJ also used it in their series on medical devices and paired it with other information about manufacturing.
A fundamental problem is that our regulatory and oversight systems are not working to keep patients safe. Often it is because they are controlled by those they regulate, for example medical boards, or their relationships with the industries they are supposed to oversee interfere with their role in protecting the public. I’ve seen the cycle of political pressure many times over the years. When an agency takes its oversight role seriously, aggressively applies new rules, and enforces the laws, members of the industry — hospitals, doctors, medical device companies – go to elected officials and complain that they are not being treated fairly or the rules are too burdensome. Elected officials call the agency staff for hearings and rake over the coals for being too strict. Then budgets get cut. That creates an atmosphere of caution and over-collaboration with the industry to the point that the public is not protected. This story has been written over and over by reporters, but things seem to still stay the same. More exposure is the only way to make that happen.
Another issue that PSAN is interested in is getting representatives for the interests of patients in the room when the next FDA User Fee Agreement is being negotiated. Currently, this process that has a significant impact on how medical devices are regulated is negotiated privately between the FDA and the medical device industry. They do not discuss the terms in public and there are no patient representatives or any other stakeholders involved.
Cost of care has attracted a lot of attention, and it’s important that reporters cover it. But quality is just as important, more important really, and it contributes to cost. We need to know enough about the cost of medical harm.
Lisa McGiffert can be reached at:
www.patientsafetyaction.org
https://www.facebook.com/groups/patientharm/
lmcgpsan@gmail.com
512-415-5405
