Sunday, September 13, 2009

Open Letter to Centers for Medicare and Medicaid Services Chief Medical Officer, Dr. Barry Straube

Advocates4QualitySafeCare wrote an 'open-letter' to Dr. Barry Straube, CMS Chief Medical Officer. To date, we have not received a response back.

Open Letter to Dr. Barry M. Straube, M.D.

CMS Chief Medical Officer

Director, Office of Clinical Standards and Quality

Centers for Medicare and Medicaid Services

Open Letter to Barry M. Straube, M.D.,
Centers for Medicare & Medicaid Services

September 1, 2009

Barry M. Straube, M.D.
CMS Chief Medical Officer
Director, Office of Clinical Standards and Quality
Centers for Medicare & Medicaid Services

Dear Dr. Straube:

I felt compelled to write after reading your response letter to Dr. Thomas' letter, regarding the summary and recommendations from the April 2009 conference, State of the Art and Charting the Challenges for the Future. Your statement, “Furthermore, there are many improvements that ESRD providers, patients and suppliers, as well as pharmaceutical and device manufacturers, might be able to achieve independent of statutory, regulatory, or administrative changes at the federal level, and are simply part of expected, “good” healthcare by providers and “responsibility” that patients should take.” made me stop and realize, even more, that this is what I, and other advocates, patients and families, have been trying to bring to the attention of providers for several years --Providers must deliver that care which patients expect - quality safe care, as well as demonstrating more accountability and responsibility for the care that is delivered and admitting when a mistake occurs regardless of the outcome. Patients can only be responsible when they have adequate information, at hand, in order to make informed, educated decisions about their care and treatment. Providers play a major role in educating patients and directing them to where they can obtain information about their disease process. Patients need to be included in all aspects of their care as well as to have whoever they want involved. Patients, and their loved ones, should be able to ask questions and question that which is being done without being negatively viewed by health care providers. It is about advocating for oneself or a loved one, not about being a 'problem' or being 'difficult'.

My candor, often met with resistance, is now supported by your (aforementioned) statement. Such things as not adhering to physician orders, not adhering to facility policies and procedures, not implementing correct practices, not including the patient in their treatment plan and allowing the patient and/or family to actively participate to the degree they desire, not fully educating patients and their families in all areas, including modalities, not encouraging patients and/or their families to bring forth observable concerns related to their delivery of care and not including patients (who else knows better about the care they receive, than the patient and/or family) and/or family members in ’advisory councils’ (or unit-based committees) as some hospitals do in order to improve care, enables a system to continue to provide unsafe care. If the aforementioned areas of care were put into practice, then perhaps these ‘improvements’ as you mentioned would support a system that delivers quality safe care. These areas that I have mentioned are a result of my review of hundreds of survey findings, speaking with patients and families from throughout the United States, as well as communicating with health care professional. I want to make it clear that I believe there are facilities that provide quality safe care and I, also, believe that there are those that do not. It is these facilities that I address.

It must be a team working together, patient/loved ones and providers. Otherwise, we will not see change. We must call upon providers to be open and honest when mistakes occur and to tell patients and their loved ones. This has proved to have positive outcomes for both the providers and those who have experienced (and their loved ones) a negative outcome. If hospitals can adopt this thinking and action, then why can't dialysis providers? As a member of a hospital advisory council, as well as a member of the World Patient Safety Day committee my goals are to strive for safe care to be delivered to all patients in all health care settings.

As you are aware, I have been attempting to bring forth, for many years, during open-door forums and through other communications, concerns related to patient safety. As a patient advocate, being involved with patient advocacy groups (non-supported by the health care industry---- dialysis and non-dialysis patient safety groups), as a family member of a dialysis patient, and retired Registered Nurse, it is my opinion that without an effective oversight and enforcement program, there will be continued practices that place patients in situations of potential or actual harm, including death. Even though there are CPMs in place that certainly concentrate on quality, there are critical aspects of delivery of care that are missing that should be concentrated on to ensure safe delivery of care - This is about ’patient safety’. It is these areas (mentioned in first paragraph) that are not included in the CPMs that need to be along side of the CPMs to truly ensure quality SAFE care. What difference does it make if a patient's anemia is being managed, or their blood is being adequately cleaned, if they end up in the hospital with a preventable infection that takes weeks or months to recover from? What difference does it make if a patient, again, has his/her anemia managed adequately, and has their blood cleaned adequately, if they end up in the hospital with a negative outcome because symptoms were not reported to the Registered Nurse for appropriate assessment and evaluation. The lack of reporting symptoms, to the Registered Nurse, for appropriate assessment has been identified in many surveys.

The Survey

It is well known that many states, for many years, have not been able to comply with CMS’ request for timely surveys in order to ensure compliance with Conditions. Then, the first question is why does CMS continue to use the state if many states are not meeting the timeframe for surveys? Why has this gone on for so many years? It is understood that CMS is responsible to ensure that beneficiaries receive quality safe care. Again, how can this be accomplished if facilities are not surveyed timely? CMS has often blamed the state, and the state has often blamed CMS, thereby, placing the patient in the middle. If this system is not working, then get rid of the state who acts as CMS’ agent. We are not doing justice to the patient when their facility is not timely inspected. Is that placing the patient as the priority? No. Beneficiaries must have some type of assurance that they are receiving quality care and safe care. The CPMs, by themselves, will not accomplish the goal of delivery of quality safe care. More is needed. It is evident that the conducted survey process identifies that which is unobserved by facility staff, e.g. the lack of implementation of effective infection controls, the lack of adherence to facility policies and procedures, and Condition compliance, etc. It is our group’s opinion, that in spite of having QI mandated, we will continue to have the same problems related to patient safety. Many believe that because facility staff do not identify (often, as evidenced in survey findings) that which causes a potential (or actual) negative outcome, that an existing problem within a facility will not be brought to the QI committee timely. It will only be addressed after a negative outcome, e.g. infection, wrong dialysate, etc. We urge CMS to address the fact that there is more to delivery of care than the CPMs when it comes to safe care and this translates into having an effective oversight and enforcement program that takes action when there are negative outcomes that patients experience, including death. Action that will translate into telling those delivering care that this is NOT acceptable delivery of care and it will not be tolerated. In fact, when I reviewed surveys I noted that some facilities that had a QI program in place, were cited for not implementing an effective process. We see providers reaching out to CMS to have their new facilities inspected timely, however, do we see providers telling CMS and/or the state that they want their facilities recertified timely? I don’t think so. Perhaps, the millions of dollars that go to lobbying could support an effective oversight and enforcement program. Perhaps, as hospitals pay JCAHO, dialysis providers should pay for recertification surveys. Something must be done. Afterall, providers want, (as do advocates, as myself), for their patients to receive quality safe care. It is not a ‘we against them’ situation, but one that all must work together. If the oversight and enforcement program (CMS) has no plans of changing, our suggestion would be to revisit the entire process of surveying and look at other avenues that will ensure there is compliance. The existing system is not working for many patients, especially those who are in facilities that have not been inspected timely. And, of course, we are all aware that without adequate sanctions, there will be continued deficiencies as noted in some surveys. I urge CMS and Congress to look at other possibilities to ensure the implementation of an effective oversight program. Again, do we really need the state, especially if some states are not able to comply with CMS’ request? Certainly, this needs to be revisited.

Infection Prevention

One must stop and ask why CMS, Congress, and others, have not taken more of a stance when it comes to infection prevention, knowing that infection continues to be the number two killer of this vulnerable population? Those who worked on the Conditions, did a great job, however, in all due respect, even though the Conditions now have a different mandated direction for infection prevention, without timely surveys being conducted, we can not be assured that facilities are implementing effective infection controls. In fact, in many surveys that I reviewed, prior to the revised Conditions, clearly stated was that some facilities had policies and procedures in line with CDC guidelines, but these practices were not being implemented. And, again, often staff do not identify incorrect practices, but the surveyor does. This is a matter of ‘prevention versus preventable negative outcome’.
We need to do more to prevent infections. Do we publicly report infection rates, type of infections, etc.? Do we mandate all facilities post their infection rates in public view in their facilities? Do we ask CMS to include infection data on the 'dialysis facility compare website'? Does Medicare withhold reimbursement for hospitalizations that are the result of a preventable acquired infection? Something needs to be done to hold providers more accountable.

Again, there is something drastically wrong when we see infection continuing to be the number two cause of death among this population. Is there effective unit-level supervision to ensure correct implementation of practices? Are new staff being adequately trained in infection prevention? Are staff being inserviced periodically? Is there a true understanding of the seriousness of not implementing correct practices? Are patients being educated on how staff will prevent an acquired infection? Are patients being educated on self-prevention of infection? Are patients encouraged to bring forth concerns related to their observations of staff, without fear of retaliation? Are patients included in unit committees focused on patient safety? And, finally, why do the CPMs not address this area of infection prevention?

If there were more effective oversight of this area we would, perhaps, see a decrease in the numbers of acquired infections, a decrease in costs related to hospitalizations, rehabilitation and medications. We could decrease costs if we only would seriously address these preventable errors that result in acquired infections. Again, should dialysis facilities be held to the same accountability standards as hospitals e.g. no reimbursement for certain preventable errors that result in negative outcomes? That is the question to be considered. But, the bottom line is 'the patient'. It is the patient who will have more quality in their life, it is the patient who will not have months of recovery and it is the patient's life we are talking about.

Optimal Dialysis

Our group supports Dr. Peter Laird’s statement, "Optimal Dialysis Deserves a Trial of Life in America. It is a matter of life and death.”

We urge CMS, congress and others to read that which Bill Peckham, Dr. Peter Laird, and others, have written about optimal dialysis ( and remember … this IS about life, quality of life and possibly premature death. Lives are at stake.
Posting of Surveys

When the proposed language was posted in the Federal Register, we recommended that surveys be posted in public view in dialysis facilities, as they are in nursing homes. This was not included in the final rule and we are wondering why? If providers are delivering quality safe care, as they profess, then one would expect the posting of surveys to be supported. Patients, and their loved ones, are not aware, for the most part, that they can obtain a copy of the survey from the state survey agency. Additionally, they are charged in many states by the page, which many can not afford. These are taxpayer dollars that support the surveys, therefore, patients should be able to obtain without cost. Patients have a right to know if their facility is providing quality safe care, or when selecting a facility, patients, and their loved ones, should have the right to visit and read, at the time of the visit, the facility's survey and ask any questions pertaining to such. Perhaps CMS' 'dialysis facility compare' website should include more information about the survey, similar to other health care facilities e.g. nursing homes, hospitals. Would this encourage providers to ensure quality safe care is being delivered. True transparency is needed to give the real picture of delivery of care. That which the 'dialysis facility compare' site provides, does not give the complete picture of care.

Dr. Straube, I would welcome the opportunity to be included in the stakeholder meetings representing the following: those who are not connected to an advocacy group that is supported by the industry or similar, those who have experienced a negative outcome, including death, as the result of a preventable error, those who have experienced retaliation, overt or covert, as a result of speaking out in order to receive safe care, those who have observed incorrect practices and behaviors, and those who are afraid to speak out.

Thank you for taking time to read the above. If you have questions, feel free to contact me.


Roberta Mikles, RN, Director
uncompensated advocates striving for quality safe care for all patients
San Diego, CA

World Patient Safety Day
annually - July 25th
Member - Legislative Action Committee


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