Patient Safety

Requiring quarterly reporting of vaccination status of staff for COVID 19 is burdensome and futile given the end of the Public Health Emergency. COVID has been mutating and although the manufacturers have attempted to keep up with these mutations, there is no available vaccine at this time for the current mutation that is causing most infections. There is no longer a mandate for vaccination of healthcare workers and most hospitals have dropped their policies requiring the vaccination. The definition of "up to date" is itself outdated and therefore, collection of this data is redundant and futile. This measure should be removed.

I am in support of the AVOID H.A.R.M. measure

Here to support the Avoid HARM measure. Would help so many people.

I would like information about the NLP algorithm and its training.

That, however, is just a minor issue.  I support Dr. Sood's comments about this measure, which is highly flawed.

I agree that evaluating 30-day risk of stroke after presentation to the ED with dizziness is important, and that many strokes - or warning signs of strokes - are not detected at first ED visit. As a general principle, more timely diagnosis of conditions with high morbidity and mortality is an important goal. However, this measure suffers from lack of wider data that the required steps will and have altered outcomes in all who undergo the testing outside of very select settings.  Simply put, narrow observations guide the underpinning. The impact in broader use - that is, effectiveness instead of efficacy - is unclear despite assertions of "easily trained to do" - that is, will care and outcomes improve by supporting this measure? I do not see good evidence of such.

For a measure to be impactful, performance measures need to be meaningful, have specific modifiable processes that are linked to the outcome being measured, and make clinical sense. This proposed measure has gaps.

The specific processes mentioned - the eye exam, or even MRI - are not clearly shown to improve the 30-day risk of stroke (outcome) or functioning (the real outcome). There was some evidence shared by the developers during the meeting that these specific processes may improve immediate diagnosis, however the outcome specified is 30-day stroke prognosis, not immediate diagnosis. 

There was also no evidence provided that these specific measures demonstrate clinical utility. There were no data on the evaluation of the benefit of overuse of diagnostic tests being greater than the clinical and financial costs of more aggressive screening processes (up to 500 MRI/case). Clinical guidelines are developed after rigorous and expert scientific review of clinical benefits versus potential adverse outcomes. Routine MRI or specific eye exams are not part of any clinical guidelines for evaluation of dizziness. 

Creating new practice guidelines with nascent data proffered by few from a select setting has real potential harm and may not achieve a benefit. Perhaps the measure needs a better look from emergency medicine and neurologic experts and also a later evaluation once better data exist.  

I became ill one November. I felt dizzy, nauseous, and my vision was slightly blurry. I went to my family doctor who said I had an ear infection in my left ear & sinus infection (had no pain or discomfort at all in that ear). Went on antibiotics and after a few weeks back to the doctor. Felt like I was on the verge of vertigo but it never came on. Family doctor said I had a virus, go home and rest and drink plenty of water. A few weeks later I was still feeling very ill with severe motion sickness feelings. I went to my ENT who cleaned out my sinuses with a suction tube and camera and my sinuses felt better but I still felt extremely ill. So a few weeks later I went back to my ENT who promptly sent me to the Emergency Room. Spent 10 hours there being tortured with tests and was feeling 1,000 times worse. No help what-so-ever. The very next day, March 1st, I saw my vestibular and balance specialist. I have had vertigo twice in the past so I know what that feels like and this wasn't vertigo but I felt dizzy so thought he might help. He did. He performed the Frenzel Goggle test. He said I had gotten a virus that I never knew I had and it attacked my left inner ear. He diagnosed me as having a left inner ear dysfunction/weakness. I was diagnosed with a Vestibular Dysfunction. I started eye balance gazing exercises at home immediately 3 times per day without fail even though they made me feel so sick and went to PT once per week for eye balance exercises. 9 weeks later I woke up and felt normal. I spent the next 2 weeks doing my exercises and then was 100% recovered. The thought of walking around sick to my stomach and still having to work, drive and function like a ‘well person’ was one of the HARDEST things I have ever had to do. You CANNOT take any medication to make you feel better because it tricks your brain into thinking you are healed and it sets you back! I know that most people think to themselves, ‘I feel so awful, something really bad must be wrong with me...how will I ever get better?’ And because I say, 'please see a vestibular and balance specialist' 'I can help you find one'...people think because these specialists aren't DOCTORS that they can't help. But they can, and they DO cure. Feeling so badly that you can't get out of bed, well...I have been there but I fought hard to keep moving. I share my story so I can help others. Here is to believing in one another. I am always here to help and can find you a balance and vestibular specialist in your area. I am also a moderator in the VeDA forums.

As the Sr. VPMA/CMO of the Johns Hopkins Health System, I am opposed to the proposed stroke measure. Given the measure is set in the Emergency Department, has this measure been endorsed by Chairs of  Emergency Medicine in the various EDs of our state, or by any state level EM society?  I question the accuracy of the method used to obtain a baseline rate of stroke in a population.  Dr. Yealy nicely outlined further issues with the proposal.  There have been many failed attempts at imposing narrow, disease specific measures - the most notable being the 4 hour then 6 hour door to antibiotic treatment for pneumonia.  While well intentioned, these measures neglect the larger issue of safety in the emergency department setting.  the largest issue impacting patient safety in the ED is ED overcrowding caused by hospital overcrowding.  Focusing on the systems issues driving this problem will have a broader, more wide ranging impact on patient safety in the ED setting. 

The Federation of American Hospitals (FAH) appreciates the opportunity to comment on this measure. While the FAH supports the intent of this measure, we remain concerned that the current specifications are flawed given the lack of a stable definition of “up to date” and the numerator, which refers the end user to a document with varying definitions of “up to date,” could negatively impact the reliability and validity of the measure. We do not believe that the new testing addresses this concern and a standardized way to collect this information must be incorporated into the measure specifications.

The FAH continues to believe that it is too soon to include a measure on COVID-19 vaccinations since the underlying evidence for this measure is still emerging and methods to address measure collection challenges related to anticipated “booster” shots will likely be required. This measure should also not only allow medical contraindications but also capture when individuals decline vaccination. We also recommend CMS revise the measure specifications to require data to be submitted in monthly or quarterly periods instead of one week a month for each quarter, in line with other Quality Reporting Program measures.

As a result, we do not believe that this measure should have endorsement continued until these concerns are adequality addressed. Thank you for the opportunity to comment. 
 

See Attached

As a spouse of a misdiagnosed patient, I feel that this is a very important measure.  Fortunately my husband has had the opportunity to help with being a advocate for misdiagnosed patients,  however without the further help more will not benefit.  

The Leapfrog Group strongly supports the Patient Safety committee’s recommendation to endorse measure #3746 – Avoid Hospitalization After Release with a Misdiagnosis—ED Stroke/Dizziness (Avoid H.A.R.M.—ED Stroke/Dizziness). This measure is important to patients and purchasers, as we continue to seek improvements in the quality and safety of care that is delivered in the US health care system, particuluary in the area of reducing harm to patients from diangostic errors. Until we can understand current diagnostic performance in this area, it will be difficult for the US health care system to prioritize interventions for improvement. This measure would be the first performance measure of stroke misdiagnosis in US hospital emergency departments and would be transformational to patients and purchasers. 

I was a patient that was harmed by a diagnostic error, and despite that harm I moved forward to help other patients. I have talked with many that have had a diagnostic error and I have worked hard to try to bring professionals and patients together to work together to improve patient outcomes. I urge this committee to continue this measure on a path towards passage for the good of all patients. Thank you for your consideration.

• I am writing in strong support of the Patient Safety committee’s recommendation to endorse measure #3746 – Avoid Hospitalization After Release with a Misdiagnosis—ED Stroke/Dizziness (Avoid H.A.R.M.—ED Stroke/Dizziness).
• My family has experienced 2 major diagnostic errors in healthcare, one resulting in the death of my husband and one resulting in the permanent brain damage of my  newborn son. The diagnostic errors that effected them and my family has repeatedly happened to many more  patients over the years due to the failure to measure , evaluate and implement actions to prevent  such diagnostic errors. 
  
  We are moving into an era where the  commitment  is to design the healthcare system around the needs and expectations of the patient. This measure is important to patients, as we continue to seek improvements in the quality and safety of care that is delivered in the US health care system.
  
  It is time to embrace the measures that matter to patients to ensure the care that patients and families deserve.

The dizzy-stroke measure based on SPADE is a critical step to our reducing misdiagnoses of stroke. It is well-known amongst emergency physicians that the complaint that vexes us the most is dizziness. There is a plethora of pathologies that can cause dizziness, from those that are fairly benign to many that are extremely dangerous. As it stands, we over-image dizzy patients and under-diagnose stroke patients - a double-whammy that not only harms patients but also inflates costs and ED crowding (which leads to yet more patient harm). We have highly sensitive and specific maneuvers that can be performed to guide diagnosis - which would both reduce imaging as well as lead to appropriate treatment. However, simply 'educating' clinicians can only go so far; in order to effect actual change, we need tools to help understand how often physicians err when working up dizziness and how we can make neurological care better for everyone. This measure is one of those important tools.

As a practicing emergency physician in a rural health system and neurologic emergencies educator who has been working to improve diagnostic accuracy in stroke for the past decade, I would like to voice my support of the dizziness/stroke evaluation measure. I would also like to respond to concerns expressed by those in opposition to this measure. 

We now have accurate, reliable and logistically feasible bedside tests to discern posterior stroke from benign causes of dizziness (Tarnutzer AA, et al. 2023 and Gerlier C, et al. 2021). The assertion that there is no evidence to demonstrate effectiveness of this approach is false. 

The appropriate selective use of MRI in cases of suspected stroke among dizzy patients has also been shown to improve the 30-day risk of stroke. The key is appropriately selecting patients, as the health care system will not sustain indiscriminate use of MRI for all causes of dizziness, particularly in rural systems-of-care such as mine. Overall utilization of MRI in nonspecific dizziness will be an important balancing measure. Prompt and accurate diagnosis at the bedside could substantially reduce MRI utilization and hospitalization, with potential savings of $500 million annually (Newman-Toker DE, et al. 2013).

The recently published GRACE-3 guideline from the Society for Academic Emergency Medicine (SAEM) endorses a standardized approach to the bedside diagnosis of dizziness in the Emergency Department (ED). The proposed measure will help provider organizations implement a clinical practice guideline developed and endorsed by EM organizations by providing a marker of improved care quality specifically related to the outcomes of interest (Edlow JA, et al. 2023).

By way of disclosure, I am a proud co-author of GRACE-3 and would like it known that its purpose was to provide supporting evidence and clarity around the appropriate diagnostic and management to undifferentiated dizziness presentations in the ED. As other comments have stated more eloquently, this is something both our patients and providers want and deserve. Quality reporting measures such as this represent a much-needed next step to towards meaningful practice improvement.

While there are certainly systems issues such as ED overcrowding that serve as key drivers to diagnostic error, opposing disease-specific quality measures that clearly stand to benefit the clinical practice of EM would also be an unfortunate error. I would encourage everyone in EM to stand behind this measure in the spirit of delivering the best possible care to our patients.    

I am Sue Sheridan, Co- founder Patients for Patient Safety US (www.pfps.us), a network of patient safety advocates committed to preventing avoidable harm in healthcare, notably missed or delayed diagnosis.  We are writing in strong support of the Patient Safety Committee’s recommendation to endorse measure #3746 – Avoid Hospitalization After Release with a Misdiagnosis—ED Stroke/Dizziness (Avoid H.A.R.M.—ED Stroke/Dizziness).

My family experienced two diagnostic errors that resulted in the death of my late husband, Pat, and the brain damage of my newborn son, Cal. Diagnostic errors result in patient death and long-term harms that are unacceptable. It devastates families, emotionally, financially, and spiritually. We live with the “what ifs” and are haunted by the preventability and lack of action by our healthcare system. Patients expect that our healthcare leaders know when patients are harmed by a missed or delayed diagnosis so they can take urgent action to prevent future harms to others. However, there is no systematic way to know when diagnostic error occurs or to know if healthcare systems are taking action to prevent them.

Stroke is a serious harm event that, in many cases, can be mitigated if diagnosed early. Accordingly, there is a pressing need for a performance measure of misdiagnosis of strokes in patients that come to the emergency department with dizziness. The greatest risk of missed stroke is in patients whose symptoms are dizziness or vertigo. In US emergency departments each year, an estimated 45,000-75,000 patients with strokes that manifest with dizziness or vertigo are misdiagnosed and may miss treatment opportunities.

As advocates, we are concerned that the scope of diagnostic error in the United States is poorly understood because it is not yet well measured.  Until we can understand current diagnostic performance in this area, it will be difficult for the US health care system to prioritize interventions that reduce harm and improve outcomes. Accordingly, this measure is important to patients, as we continue to seek improvements in improving timely diagnosis and the safety of care overall.  This measure would be the first performance measure of stroke misdiagnosis in US hospital emergency departments and would be transformational for the field.

Sue Sheridan

The structure of health care in the US is struggling with financial, insurance and other concerns, to deliver the best health care to patients while focusing on other issues overshadows it. The Avoiding HARM measure is a move to help focus the field on accuracy of diagnosis and patient care. I support this measure, in order to help clinicians move toward better diagnostic strategies for patients with critical and life changing issues such as posterior circulation stroke. It's one of many important ways that we can help to ensure patient safety in the field of medicine. 

We are Founding Members of Patients for Patient Safety US (www.pfps.us), a network of patient safety advocates committed to preventing avoidable harm in healthcare, notably missed or delayed diagnosis.  We are writing in strong support of the Patient Safety Committee’s recommendation to endorse measure #3746 – Avoid Hospitalization After Release with a Misdiagnosis—ED Stroke/Dizziness (Avoid H.A.R.M.—ED Stroke/Dizziness).

Stroke is a serious harm event that, in many cases, can be mitigated if diagnosed early. Accordingly, there is a pressing need for a performance measure of misdiagnosis of strokes in patients that come to the emergency department with dizziness. The greatest risk of missed stroke is in patients whose symptoms are dizziness or vertigo. In US emergency departments each year, an estimated 45,000-75,000 patients with strokes that manifest with dizziness or vertigo are misdiagnosed and may miss treatment opportunities.

As advocates, we are concerned that the scope of diagnostic error in the United States is poorly understood because it is not yet well measured.  Until we can understand current diagnostic performance in this area, it will be difficult for the US health care system to prioritize interventions that reduce harm and improve outcomes. Accordingly, this measure is important to patients, as we continue to seek improvements in improving timely diagnosis and the safety of care overall.  This measure would be the first performance measure of stroke misdiagnosis in US hospital emergency departments and would be transformational for the field.

Susan Sheridan & Martin Hatlie

Founding Members, Patients for Patient Safety US