by Rose Rohloff
On July 12, 1974, the National Research Act (Pub. L. 93-348) was signed into law, there-by creating the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. One of the charges to the Commission was to identify the basic ethical principles that should underlie the conduct of biomedical and behavioral research involving human subjects.
The 1974 Research Act was created in entirety from the Belmont report, and put into place to prevent the Government, it agencies or representatives, military and private companies, from violating an individual's freedom: by forcing, tricking or coercing persons for research, testing and administration of unknown injections/materials, and experimental procedures. This law was enacted after a century long track record of precedence including, and not limited to, the following:
Demonstrated lack of Respect for Persons and their protections in violation of 1974 law.
1- Autonomous agents, individuals capable of deliberation about personal goals and of acting under the direction of such deliberation. The Government and companies have to give weight to autonomous persons' considered opinions and choices, and cannot obstruct their actions and judgments, nor deny individual freedom to act on considered judgments, and cannot withhold information necessary to make a considered judgment. Necessary information includes - but not limited to - all medical opinions by established, industry experts, health status, the necessary assessments, labs, with close monitoring of physical lab and test follow ups of each and every autonomous persons as part of clinical research and testing, along with full documentation of testing, efficacy, use of chimera for research and testing, any and all conceivable side effects, and interactions of conditions.
2- persons with diminished autonomy are entitled to added protections.
Violators to the law have been marketing to the most vulnerable, including the immature and the incapacitated who were in need of extra, added protections, even to the point of excluding them from any injections or procedures which may harm them; violating added safety precautions for children, elderly, or those with diminished capacity.
Informed consent - must include full disclosure of ALL contents to be injected, any and ALL possible side effects (which can be several pages long), how those persons are individually to be closely monitored, safety guidelines, and above all the right to say no before or at any time, and full reporting of all individuals regarding their safety monitoring/labs/assessments, and any and all side effects. By promoting COVID shots all still under clinical trial/research, and coercing with careers/jobs, inability to travel, etc. in order to take the shots, this law is being violated through: lack of informed consent, lack of protections of autonomous persons, and/or illegally acting as IRSB board members marketing to those not autonomous and capable of self-determination, with higher standards of protection to be invoked, and assuming the role for their safety.
The maxim "do no harm" has long been a fundamental principle of medical ethics. Claude Bernard extended it to the realm of research, saying that one should not injure one person regardless of the benefits that might come to others.
An agreement to participate in research constitutes a valid consent only if voluntarily given. This element of informed consent requires conditions free of coercion and undue influence.
Undue influence also includes offers of an excessive, unwarranted, inappropriate or improper reward or other overture in order to obtain compliance. Also, inducements that would ordinarily be acceptable may become undue influences if the subject is especially vulnerable as in the case of targeting children, persons with limited capacity, and elderly with elements of mental defect, or instilling fear.
Short term morbidity and mortality cases from the shots are well reported and known, such as death, myocarditis along with spontaneous cardiac arrest with no warning, debilitating neurological conditions, etc. And, there is no means yet to determine mid and long term effects because Phase I trials have not been competed, let alone Phase II and III - which is vital information in order to determine informed consent.
Injustice has been performed with companies and government representatives, by involving vulnerable subjects, including the young, those unable to fully comprehend with all necessary information, and scaring parents with compromised capacity for free consent. In addition to lack of individual, tightly scheduled, continual monitoring and follow ups, autopsies of all persons involved in this trial participation should be conducted for reporting by the pharmaceuticals companies for any and all persons who received the shots, as well as labs determining efficacy and detriments (as examples, antigen creation, D-dimer, Pulse Cardiac and Troponin Tests) for all those who were coerced or unduly influenced to participate in research.
This law was created to protect people from government abuse through experimentation. The government cannot arbitrarily dismiss components, create resolutions or stipulations to supersede the law, as to invalidate its protection of individuals from them, including, but not limited to Health and Human Services (HHS) Center for Disease Control (CDC), Food and Drug Administration (FDA), National Institute for Health (NIH), etc. and pharmaceutical companies, etc.
Persons have been illegally acting as members of, or bypassing, IRSB safety review and monitoring of each and every person receiving injections, with open undue influence and coercion, to participate in Covid injections. Coercion has been especially directed to the diminished autonomous, children and elderly, through TV ads, library recordings, verbal encouragement, schools or other public venues acting as government agents, and/or clinical researcher recruiting participants, and/or illegally as untrained IRSB member who is not following up to ensure safety of the people they recruited, coerced or used undue influence.
Overall lack of informed consent has become too often common practice across the healthcare industry, including people being given consent forms hours or minutes prior to surgery; no alternative treatments or lifestyle-nutrition changes prior to medications begin prescribed, and undue influence to intubate or perform surgery on patients in lieu of alternative treatments.
by Rose Rohloff
Calm intelligence, professionalism, logic and sense. Nine (9) doctors interviewed https://www.bitchute.com/video/2JPy7qZiXvNr/ regarding Covid, Hydroxychloroquine (HCQ) and masks.
The Push For Value-Based Care
by Rose Rohloff
Value is a relative term based upon personal perception, and oftentimes great marketing. True value is based upon insightful knowledge of what entails quality along with the cost of delivering goods and services. Value-based care is the new buzz for basing reimbursement in the healthcare industry. But again, what is value care: personal perception, marketing, cost?
The primary issue with such score deviations is determining if poor marks are isolated instances (one offs); or, if the variance of only highest and lowest reflect the knowledge of reviewers. Are the high ratings from non-healthcare persons based on perception of the veneer friendliness and scheduling, with one star comments based on specific quality requirements, care competency posted by those with healthcare insight/experience?
As a 35+ year healthcare veteran, an answer was determined accompanying a Medicare patient ‘John’, in his mid-80s who experiences early stage dementia, to the office for a post-op visit for a leg stint placement.
Upon arriving, another elderly patient (80s) was sitting outside, unattended in wheelchair, hot sun, 100 degree weather, no water. When asked why he was there, he stated, “I can’t stand the freezing air conditioning inside while waiting for a ride.” After walking John into the lobby, the gentlemen clearly seen through the glass door was pointed out to the receptionist stating that he was left in hot sun, no water, unattended. The receptionist stated, “It is his choice to stay out there.” I then stated, “Get someone to check on him, give him water, put him in the shade and check when his ride is supposed to arrive and monitor him if it is delayed or bring him inside.”
One person escorted us back to exam room. She did not introduce herself or her title. She proceeded to take the blood pressure with no other vital signs (unknown if a secretary, an aide, a nurse or tech).
She then asked the patient, “How much do you weigh?” He gave a number. As patient champion I responded, “He doesn’t know, he has not weighed himself. You need to weigh him yourself.” She responded, “We don’t have a scale.” She then left. I followed her witnessing her documenting the incorrect data.
I reiterated he has dementia with no idea how much he weighs. She replied, “It doesn’t matter anyways, we just need to put something in the record.” She was reflecting an 11 pound weight loss from previous recording. It is unclear if they performed the previous weighing, if it was done just prior to surgery to determine proper anesthesia delivery for his surgery.
Another woman in scrubs entered the exam room without introducing herself or her title, asking John to remove his shoes and socks. (The scheduled appointment was with the PA so the patient assumed her identity.)
She asked him if his wound was healed and he replied, “Yes.” She documented something in the chart without ever assessing his wound for healing or determining if there was infection.
She bent down and felt his feet with her whole hands stating they feel warm, and then asked if he had numbness in his feet. John responded, “Yes.”
Having worked as a registered nurse (RN) in cardiovascular and neuro intensive care units (ICUs), I know she never did pedal (foot) pulse checks x4 comparing both feet. She never assessed location of numbness, or if chronic/intermittent, positional with sitting/, standing, walking, etc.
The family had asked if aspirin could be stopped as the patient has experienced nose bleeds in the past. The staff person responded yes and since there was 90% blockage of the previous stint, it was cleaned out and continue Plavix. There was no establishment of lab work as part of care plan determining effectiveness of the medications, especially since the previous stint occluded.
"1,750 or so stent patients are also prescribed Plavix to prevent clots from forming around the stent, but of that group, approximately 500 (29%) carry a genetic variation that prevents them from converting Plavix into its active form. This gene-related lack of response stands to be "especially severe" in about 50 (3%) of those patients, who won't derive any benefit from Plavix - 2010 Vanderbilt Medical Center
Perceived value based on quality versus true value and cost
The care competency and quality as true value-based care during the visit includes:
- lack of basic cleanliness standards with severe cross contamination practices
- no introduction of name or title of any staff member
- fraudulent documentation in the electronic medical record (EMR)
- no assessment performed during a specific post operative visit (a family member could have taken the BP and said his feet felt warm.)
- lack of care planning and evaluation of medication regime
- unnecessary secondary office visit charging for follow up
- another elderly patient left unattended in the hot sun
If the U.S. healthcare system wants to achieve true value-based care, we need an educated population, higher accountability of staff standards with the ability to send evaluations direct to payers based on specific facts and not emotion, and surveys must include care competency reviews versus only veneer questions of politeness, room appearances, and on time scheduling.
Mayo Clinic Launches $1B Upgrade To Electronic Records System
CBS Minnesota 7/13/2017
Mayo Clinic defends executive raises
Molly Gamble (Twitter), Becker's Hospital Review 12/8/2022
Financial hits brought on by the COVID-19 pandemic in 2020 left many Rochester, Minn.-based Mayo Clinic executives taking small pay cuts. Compensation for CEO Gianrico Farrugia, MD, dropped 1 percent, for instance.
The next year, Mayo returned to raise executive pay, with a total of 26 employees reporting compensation of more than $1 million in 2021. That tally is up from 23 in 2020 and 21 in 2019.
In 2021, Dr. Farrugia's compensation increased by 27 percent to $3.48 million. Then-Chief Administrative Officer Jeff Bolton's compensation increased by 24 percent to $2.11 million. Kent Thielen, MD, CEO of Mayo Clinic in Florida, saw his compensation increase by 20 percent to $1.79 million and Richard Gray, MD, CEO of Mayo Clinic in Arizona, saw his compensation increase 26 percent to $1.78 million in 2021.
As the dark side of IVF slowly comes into focus, even more transparency is needed
by Pamela Mahoney Tsigdinos, July 27, 2018
CEO of health system, "Not every patient needs a primary care physician." A response from patients, the population.
The June 29, 2018 BECKER'S Hospital Review article shares the viewpoint "Froedtert CEO Cathy Jacobson: Not every patient needs a primary care physician" (PCP). The article is the perspective from the viewpoint of a health system CEO. The following is a perspective, counterview from patients, the individuals in the population.
Many people have expressed utter frustration from lack of a good Primary Care Doctor, warranting unnecessary ER visits because a doctor will not call back; the lack of one doctor in charge who would simply LISTEN to them, who knows them - not as personal friends, but with an in-depth professional relationship.
I have been asked several times in various states, "Do you know of any good Primary Care Doctors? I cannot find one." Universally, I am hearing about the lack of comprehensive assessments, getting to know and listen to what is going on, causing the passing through of patients to specialists versus a primary care doctor creating a plan of care and focused tests for getting an actual diagnosis; along with hospital visits with increasing costs that could and should be avoided because of the conditions getting worse or prolonged because the doctor does not take the time to get to know the patient and their symptoms.
Her quote continues, "... insight further into consumer driven wants, we are finding that a substantial sector of the population does not want or need a primary care physician relationship. People need primary care but not necessarily a physician relationship." The issue is the primary care physician practices have been acquired by the hospitals with the biggest complaint from people, of not being able to find a PCP, and those now under health systems, the doctor only giving 15 minutes of time and then passing off with no plan of care, simply writing another prescription. Many in the public just find it faster or are being told to just go to the ER. From the perspective of health system CEOs, it would appear primary care is not wanted or needed. But when actually speaking with individuals across the country, it is the opposite from the lack of care coordination, and "the doctor doesn't know me and is not taking the time to listen to figure out an actual diagnosis."
Population Health: has the focus on big data, populations & large systems caused the loss of individuals?
Kyle Reyes, CEO, The Silent Partner Marketing
The solution is bringing analysis down to the most base level of management with front line analysis, to coincide with first-hand observation, the voice of the patient & their caregivers/champions, and reducing the ever growing administrative overhead. Bigger is not better for addressing health and care of populations, when the focus is shifted upward with large systems where individuals are lost: Especially when the individual issues are indicative of the core problems that need to be addressed for quality care delivery.
The need for P&P Reviews
This week, reports were released in the media that US homes need Narcan to aid in opioid overdose epidemic, surgeon general advises
The general public needs to be aware: Naloxone has been reported to foster increased abuse of drugs by allowing revival of overdosing for continuing to take more drugs. Naloxone is the generic of Narcan. Just as EpiPen is only the delivery system and not the generic drug Epinephrine, It is important to know the difference between the brand name versus the generic drug name.
The danger of advising the untrained public to distribute emergency medicine
Many clinicians, let alone the general public, are not specifically trained in the proper dosage and treatment with Naloxone for the various forms and dosages of opioids and heroin.
FDA Advisory Committee on the Most Appropriate Dose or Doses of Naloxone to Reverse the Effects of Life-threatening Opioid Overdose ... Sept 2016
"The effectiveness of naloxone, and thus the exposure required, will depend on the opioid dose, the potency of the opioid in binding receptors, the lipophilicity of the opioid in crossing into the CNS system and the elimination half-life of the opioid, together with patient factors (7, 26). Appendix  and [2a] includes further information on naloxone pharmacology. The complex pharmacology of appropriate dosing is further compounded as often the fentanyl involved is illicitly manufactured without normal procedures or controls and may be introduced surreptitiously into heroin or prescription painkillers. Reports from the field confirm the need for additional naloxone doses to reverse opioid overdoses including those involving more potent fast onset synthetic opioids."
Narcan (Naloxone HCL) Use in Opiod Overdose: A Perspective
An important point for the general public who is not used to or trained in emergency medicine, this “rescue” drug is only the first step in the opioid crisis ... not the end all and be all of treatment. I would like to respond to this “advisory report” from the Surgeon General as a pharmacist, an Emeritus Professor, Pharmacy Practice from a College of Pharmacy, former President/Chair of the Michigan Pharmacist Association (MPA) and Fellow of this Association; and lastly as a chronic pain patient.
I have used opioids now for chronic pain management after a car accident almost twenty-years ago. I will admit, I was taken aback by my family physician about a month ago being given a prescription for Narcan (generic name Naloxone) as a “precautionary measure” for my chronic opioid use. The form I was prescribed is a nasal formulation vs. the oral/injection form. When I took it to a pharmacy to be filled, I had to undergo “special counseling” by a pharmacist (even with my credentials) which consisted of a video on proper use and a warning that after use, 911 had to be called and I was to be taken to the emergency room for follow-up. This is the proper follow-up when someone is prescribed any rescue medication for a drug reaction. The Naloxone is only to be given when a known opioid (i.e. codeine and it’s derivatives; Fentanyl, Meperidine, etc...) is given or taken in life-threatening incidences. I was instructed, "Were you aware that Naloxone has two elimination half-lives because this drug has an active metabolite; and, were you aware that Naloxone and Naltrexone are different agents, but are easily confused."
I believe giving someone this agent for overdose situations is giving a false sense of security that nothing else needs to be done. Nasal Naloxone is like putting a bandage on a cut artery. You may stop the blood flow at the moment, but the wound will continue to bleed if the wound isn’t sutured properly. Without appropriate emergency room follow up of an opioid overdose the person may die from that overdose.
Many opioids vary in dose, strength, predictability and most of all drug half-life. Knowing the half-life of drugs is essential to know how long the drug is going to last in your body. Drug half-life’s, drug absorption, distribution and elimination is well covered in Colleges of Pharmacy in courses such as pharmacology, pharmacokinetics and pharmacotherapeutics. Pharmacists do not know the pharmacokinetics on every drug substance out there by memory, and we are called the drug experts. Physicians do not have nearly as much education on medications as pharmacists, yet they are the first line of treating drug overdoses in emergency situations along with the nurses, Physician Assistants and Nurse Practitioners.
The general public is being provided a false sense of security by the media to carry this drug in their homes to address the opioid crisis. The public needs to be AWARE there is more to treating an opioid overdose than just squirting this agent up their nose.
Joan M. Rider-Becker, BS, PharmD, FMPA
Retired, Emeritus Professor, Pharmacy Practice Ferris State University College of Pharmacy
B.S. Pharmacy-Ferris State University College of Pharmacy-1987
Pharmacy Practice Residency-Bronson Hospital Kalamazoo, MI-1987-1988
Doctor of Pharmacy (PharmD), University of Michigan-College of Pharmacy Ann Arbor, MI 1990
by Rose Rohloff
Another common practice over the past decade is the prescription of broad spectrum antibiotics for non-life threatening conditions. Broad spectrum antibiotics are for use in life threatening conditions/sepsis when there is no time to wait for a culture, or the inability to do a culture. Broad spectrum antibiotics target the necessary bacteria needed in the adult intestinal tracts; and so, the standard practice has become the second prescribing for probiotics; the requiring of multiple medications to be taken. Additionally, numerous reports over the last 10 years have shown the continued misuse of antibiotics (e.g. CDC Grand Rounds) causing antibiotic resistance, with the need for more and more antibiotics to be created and used.
What has caused the layering of medications
Consumer engagement is needed with all medications being prescribed to be fully empowered, to understand: 1) the need for prescriptions, why and when appropriate, 2) the side effects of medications to determine alternatives versus adding on more medications, and 3) to eliminate the misuse of medications without the continued layering of additional drugs. Antibiotics should only be used when the body, given time, cannot fight a severe bacterial infection. And, antibiotics should only be given out after a culture is performed to eliminate a virus as the cause, or to target the specific bacteria. Broad spectrum antibiotics should only be used with life threatening-septic issues while waiting for a culture, or there is not the ability to perform a culture.
Killing me softly - with kindness
Dr. Lee Beecher and David Racer in their book Passion for Patients wrote, "Dr. Kübler-Ross … called me to her office … “Ach, you’ve got a problem.” She said I needed to more clearly communicate... You have to learn about how to be a good son-of-a-bitch.” Pritzker (medical school at University of Chicago) taught me how to be a problem solver ... No one told me what I had to believe or how I had to think. They taught me how to think and apply what I learned to help my patients." (pages 55-57)
Today I read someone describing the Forbes article by Brent Gleeson, “Apparently, during SEAL training, peer reviews are a weekly event. They have a process called top five, bottom five. Every week you anonymously rank the top five performers in the class as well as the bottom five.”
Unfortunately, with political correctness and mandating diversity in healthcare, leaders and peers cannot or choose not to do ranking and hiring based upon performance. I have seen in the health industry that no one is allowed to hurt a doctor/nurse's feelings because they are being incompetent or under-performing, with patient's lives at stake.
It is a wonderful idea of ranking on performance so everyone pushes each other to excellence. But when a 30 year veteran nurse is told to shut up because she was holding accountable the new doctors and nurses not performing, competency rating (especially by knowledgeable veterans) was a great practice that worked 20-30 years ago - but one that is not tolerated today. The result, medical errors are now the #3 cause of death. The industry is killing people with our focus on kindness versus caring competency.
Personally, I want a well trained, experienced, compassionate son-of-a-bitch taking care of me, as opposed to someone who is being nice while not knowing what they are doing. I want a doctor and nurse who takes care of me so I can go home and I don’t have to see them again because they are my quality clinicians, not my pals.
Elisabeth Kübler-Ross, Passion for Patients, (page 62)
The media writes about the desire for transparency with many in the public demanding posted costs for healthcare; however, the public fails to understand - healthcare is not the same as other businesses. First, in business production & marketing creates increased sales volume. Whereas, in healthcare volume is driven by need, and the primary goal of providers should be getting, keeping people healthy, in effect driving away their business. Second, the highest percent of revenue for hospitals comes from the government agency Health and Human Services (HHS), especially the Medicare division. Below is the formula for calculating inpatient payment. So unlike businesses, utilities, or other services, healthcare costs, prices and payments are not simple amounts to readily comprehend. Healthcare information has been publicly available, now is the time to educate consumers in the population of how to find and understand it to champion their care.
Day’s statements exemplify an important component that has been lost in healthcare training - that of muscle, or specifically, movement memory. Clinicians are supposed to be trained in school regarding the need and proper technique for handwashing. More importantly, clinicians used to have extensive clinical time working in patient areas developing the movement memory for proper hand washing, and automatically keeping in mind what is clean vs. dirty, where established sterile fields are located with maintaining of sterile gloved hands. The training was extensive and repetitive, for clinicians to automatically move appropriately in fast paced, life threatening situations - to not have to think and just act. One common, simple example is the insertion of IVs for fluid administration or needles for drawing blood. The needle or IV cannula (the needle with covered sheath inserted into the vein) is sterile, with clinicians wearing nonsterile gloves. The skin is typically wiped with alcohol to clean, and then all too often clinicians press nonsterile gloved fingers on the cleaned skin to feel for the vein; thus, contaminating the cleaned surface of the patient’s skin where insertion directly into their vein will occur. Even though the nurse/doctor is wearing clean gloves, they are not sterile, and worn to protect the clinician. With repetitive movement training, clinicians would press to find the vein before properly cleaning the skin, and clean their gloved fingers at the same time as the patient’s skin.
Two frequent complaints often heard from patients, "They dug around in my arm and could not find the vein, it was so painful." "They poked me five times because they did not know what they were doing." Blood draws and starting IVs is a skill, just like shooting at a target or in high stress a gun fight, that requires proper training of technique, and more importantly, repetitive practice - especially with the understanding when someone's life depends upon it. Additionally, the conditioned good technique should be second nature to purge ALL air from needles and tubing, including from the side ports of IV tubing, to prevent the potentially fatal embolus as a hospital acquired condition (HAC).
With the great reduction of hands on clinical time in schools (with replacement of online theory, population/global health, writing, and shadowing nurses), this movement memory training has been lost, with the shift of cost to hospitals for training, buying expensive monitoring equipment, or addressing the subsequent HAIs/HACs. Bringing the ingrained, repetitive movement training back to school training would instill within clinicians and CNA/PCT caregivers the instinctual, reactionary awareness of dirty versus clean or sterile, and proper IV/needle insertion, while delivering care; whether normal daily care or imminent life versus death situations – because they just do what they are trained to do without having to stop and think through quality actions.
WatchPAT is an FDA-approved portable diagnostic device that uniquely uses finger based physiology and innovative technology to enable simple and accurate Obstructive Sleep Apnea (OSA) testing while avoiding the complexity and discomfort associated with traditional air-flow based systems.
5 thoughts on healthcare consumerism, interview with Rose Rohloff by Morgan Haefner, Becker's hospital review
Ms. Rohloff, a 35-year healthcare veteran with experience in nursing, business and information systems, spoke with Becker's Hospital Review about providing consumers with more detailed evaluation of quality care delivery. [read more]
One important step healthcare leaders have not done - ask the consumer, those individuals who make up the population - what is the public’s understanding or desire for Population Health. Therefore, I went out to the public to ask, and listen to them. [read more]
Domain experts sharing leading expertise for consumers.
Champion Your Own Care
Clinician Quality Education
Medical Care Coordination
Transitioning Care Coverage