Acute renal failure (ARF) has traditionally been defined as the abrupt loss of kidney function that results in the retention of urea and other nitrogenous waste products and in the dysregulation of extracellular volume and electrolytes. The loss of kidney function is most easily detected by measurement of the serum creatinine which is used to estimate the glomerular filtration rate (GFR).
Three problems are associated with the use of the serum creatinine to quantitatively define ARF:
* Serum creatinine does not accurately reflect the GFR in a patient who is not in steady state. In the early stages of severe acute renal failure, the serum creatinine may be low even though the actual (not estimated) GFR is markedly reduced since there may not have been sufficient time for the creatinine to accumulate. (See "Assessment of kidney function: Serum creatinine; BUN; and GFR".)
* Creatinine is removed by dialysis. As a result, it is usually not possible to assess kidney function by measuring the serum creatinine once dialysis is initiated. One exception is when the serum creatinine continues to fall on days when hemodialysis is not performed, indicating recovery of renal function.
* Numerous epidemiologic studies and clinical trials have used different cut-off values for serum creatinine to quantitatively define ARF [1].
The lack of consensus in the quantitative definition of ARF, in particular, has hindered clinical research since it confounds comparisons between studies. Some definitions employed in clinical studies have been extremely complex with graded increments in serum creatinine for different baseline serum creatinine values [1,2]. As an example, in a classic study of the epidemiology of hospital-acquired acute renal failure, ARF was defined as a 0.5 mg/dL increase in serum creatinine if the baseline serum creatinine was ≤1.9 mg/dL, an 1.0 mg/dL increase in serum creatinine if the baseline serum creatinine was 2.0 to 4.9 mg/dL, and a 1.5 mg/dL increase in serum creatinine if the baseline serum creatinine was ≥5.0 mg/dL [2].
The Acute Dialysis Quality Initiative (ADQI) was created by a group of expert intensivists and nephrologists to develop consensus and evidence based guidelines for the treatment and prevention of acute renal failure [3]. Recognizing the need for a uniform definition for ARF, the ADQI group proposed a consensus graded definition, called the RIFLE criteria [4]. A modification of the RIFLE criteria was subsequently proposed by the Acute Kidney Injury Network, which included the ADQI group as well as representatives from other nephrology and intensive care societies [5-7].
Because of these initiatives, the term acute kidney injury (AKI) was proposed to represent the entire spectrum of acute renal failure. This topic review will address the current definitions of acute renal failure, particularly the RIFLE criteria and the AKIN modifications.
RIFLE CRITERIA — The RIFLE criteria consists of three graded levels of injury (Risk, Injury, and Failure) based upon either the magnitude of elevation in serum creatinine or urine output, and two outcome measures (Loss and End-stage renal disease). The RIFLE strata are as follows [4]:
* Risk — 1.5-fold increase in the serum creatinine or GFR decrease by 25 percent or urine output <0.5 mL/kg per hour for six hours
* Injury — Twofold increase in the serum creatinine or GFR decrease by 50 percent or urine output <0.5 mL/kg per hour for 12 hours
* Failure — Threefold increase in the serum creatinine or GFR decrease by 75 percent or urine output of <0.5 mL/kg per hour for 24 hours, or anuria for 12 hours
* Loss — Complete loss of kidney function (eg, need for renal replacement therapy) for more than four weeks
* ESRD — Complete loss of kidney function (eg, need for renal replacement therapy) for more than three months (figure 1)
The RIFLE criteria correlated with prognosis in a number of studies [8-14]. As an example, a systematic review of 13 studies demonstrated a stepwise increase in the relative risk of death in patients who met the RIFLE criteria for various stages of AKI [14]. Compared to patients who did not have AKI, patients in the RIFLE stages of "risk," "injury," and "failure" had increased relative mortality risks of 2.4 (CI 1.94-2.97), 4.15 (CI 3.14-5.48), and 6.37 (CI 5.14-7.9). Despite significant heterogeneity among studies, results from most individual reports were qualitatively similar.
Limitations — There are several important shortcomings to the RIFLE criteria:
* The "risk," "injury," and "failure" strata are defined by either changes in serum creatinine or urine output. The assignment of the corresponding changes in serum creatinine and changes in urine output to the same strata are NOT based on evidence. In the one assessment of the RIFLE classification that compared the serum creatinine and urine output criteria, the serum creatinine criteria were strong predictors of ICU mortality, whereas the urine output criteria did not independently predict mortality [12]. Thus, if the RIFLE classification is used to stratify risk, it is important that the criteria that result in the least favorable RIFLE strata be used [4].
* As mentioned above, the change in serum creatinine during acute renal failure does not directly correlate with the actual change in glomerular filtration rate, which alters the assignment of that patient to a particular RIFLE level. As an example, in a patient with an abrupt decline in renal function in the setting of severe ARF, the serum creatinine might rise from 1.0 to 1.5 mg/dL (88.4 to 133 micromol/L) on day one, 2.5 mg/dL (221 micromol/L) on day two, and 3.5 mg/dL (309 micromol/L) on day three. According to the RIFLE criteria, the patient would progress from "risk" on day one to "injury" on day two and "failure" on day three, even though the actual GFR has been <10 mL/min over the entire period. This issue is intrinsic to any assessment of acute renal failure based upon the serum creatinine level.
* It is impossible to calculate the change in serum creatinine in patients who present with ARF but without a baseline measurement of serum creatinine. The authors of the RIFLE criteria suggest back-calculating an estimated baseline serum creatinine concentration using the four-variable MDRD equation, assuming a baseline GFR of 75 mL/min per 1.73 m2 [4]. However, this approach has not been prospectively validated.
AKIN CRITERIA — Given these limitations, a modification of the RIFLE criteria has been proposed by the Acute Kidney Injury Network. The AKIN proposed both diagnostic criteria for ARF and a staging system that was based on the RIFLE criteria [5-7]. In addition, the term acute kidney injury (AKI) was proposed to represent the entire spectrum of acute renal failure.
Diagnostic criteria — The proposed diagnostic criteria for ARF are an abrupt (within 48 hours) absolute increase in the serum creatinine concentration of ≥0.3 mg/dL (26.4 micromol/L) from baseline, a percentage increase in the serum creatinine concentration of ≥50 percent, or oliguria of less than 0.5 mL/kg per hour for more than six hours (table 1).
The latter two of these criteria are identical to the RIFLE "risk" criteria. The addition of an absolute change in serum creatinine of ≥0.3 mg/dL is based on epidemiologic data that have demonstrated an 80 percent increase in mortality risk associated with changes in serum creatinine concentration of as little as 0.3 to 0.5 mg/dL [15]. Including a time constraint of 48 hours is based upon data that showed that poorer outcomes were associated with small changes in the creatinine when the rise in creatinine was observed within 24 to 48 hours [16,17].
Two additional caveats were proposed by the AKIN group:
* The diagnostic criteria should be applied only after volume status had been optimized
* Urinary tract obstruction needed to be excluded if oliguria was used as the sole diagnostic criterion.
A flaw with the last caveat is that, according to the current definition, AKI would still be used to describe the patient with acute urinary tract obstruction and an acute increase in serum creatinine. It is not clear whether the AKIN modifications to RIFLE have substantively changed the classification of patients with AKI or improved its ability to predict hospital mortality [18].
Staging system — The classification or staging system for ARF is comprised of three stages of increasing severity, which correspond to risk (stage 1), injury (stage 2), and failure (stage 3) of the RIFLE criteria. Loss and ESRD are removed from the staging system and defined as outcomes.
The clinical applicability of these staging systems is uncertain. However, they will likely have some utility in standardizing the definitions for epidemiologic studies and for establishing inclusion criteria and endpoints for clinical trials.
Ultimately these definitions are likely to be replaced by more sensitive and specific biomarkers of renal injury.
CLINICAL UTILITY — The RIFLE and AKIN criteria have helped to focus attention that decrements in renal function that result in small changes in serum creatinine concentration are associated with significant clinical consequences. However, the precise clinical utility of these criteria is uncertain. There is also an inherent confusion within these criteria as to whether prerenal and obstructive etiologies of ARF are subsumed in or are external to the definition of AKI.
We believe that these criteria have greatest utility in epidemiologic studies and in defining consistent inclusion criteria and/or endpoints for clinical studies. Their utility at the bedside is less clear and it seems likely that they will eventually be replaced at least in part by sensitive and specific biomarkers of renal tubular injury. The use of such biomarkers, analogous to troponin as a marker of myocardial injury, will permit development of a new paradigm for classifying acute kidney injury that is not solely dependent upon serum creatinine or other functional markers.
We do believe that adoption of the term acute kidney injury (AKI) to replace the older terminology of acute renal failure is highly appropriate. Just as acute lung injury is used to describe acute pulmonary injury that has not progressed to overt organ failure, we believe that AKI is more representative of the full spectrum of acute kidney dysfunction.
SUMMARY
* Acute renal failure (ARF) has traditionally been defined as the abrupt loss of kidney function resulting in the retention of urea and other nitrogenous waste products and in the dysregulation of extracellular volume and electrolytes. (See 'Introduction' above.)
* Although the loss of kidney function is most easily detected by measurement of the serum creatinine, several problems are associated with the use of this measure to quantitatively define ARF, particularly the lack of consensus in the quantitative definition. (See 'Introduction' above.)
* The Acute Dialysis Quality Initiative (ADQI) has proposed a graded definition of ARF called the RIFLE criteria. The Acute Kidney Injury Network (AKIN) modified the RIFLE criteria in order to include less severe ARF, to impose a time constraint of 48 hours, and to allow for correction of volume status and obstructive causes of ARF prior to classification. (See 'Rifle criteria' above and 'AKIN criteria' above.) These criteria have their greatest utility in epidemiologic studies.
* The AKIN proposed the term acute kidney injury (AKI) to represent the entire spectrum of acute renal failure. The proposed diagnostic criteria are an abrupt (within 48 hours) absolute increase in the serum creatinine concentration of ≥0.3 mg/dL (26.4 micromol/L) from baseline, a percentage increase in the serum creatinine concentration of ≥50 percent, or oliguria of less than 0.5 mL/kg per hour for more than six hours. These criteria will likely be revised, and possibly replaced, as biomarkers of tubular injury are developed. (See 'Diagnostic criteria' above.)
* We agree that adoption of the term acute kidney injury to replace the older terminology of acute renal failure is highly appropriate. AKI better represents the full spectrum of acute kidney dysfunction. (See 'Clinical utility' above
Wednesday, September 15, 2010
Sunday, September 12, 2010
FLexner Report
The Flexner Report[1] is a book-length study of medical education in the United States and Canada, written by the professional educator Abraham Flexner and published in 1910 under the aegis of the Carnegie Foundation. Many aspects of the present-day American medical profession stem from the Flexner Report and its aftermath.
The Report (also called Carnegie Foundation Bulletin Number Four), called on American medical schools to enact higher admission and graduation standards, and to adhere strictly to the protocols of mainstream science in their teaching and research. Many American medical schools fell short of the standard advocated in the Report, and subsequent to its publication, nearly half of such schools merged or were closed outright. The Report also concluded that there were too many medical schools in the USA, and that too many doctors were being trained. A repercussion of the Flexner Report resulting from the closure or consolidation of university training, was reversion of American universities to male-only admittance programs to accommodate a smaller admission pool. Universities had begun opening and expanding female admissions as part of women's and co-educational facilities only in the mid-to-latter part of the 19th century with the founding of co-educational Oberlin College in 1833 and private colleges such as Vassar College and Pembroke College.
[edit] History
In 1904 the AMA created the Council on Medical Education (CME) whose objective was to restructure American medical education. At its first annual meeting, the CME adopted two standards: one laid down the minimum prior education required for admission to a medical school, the other defined a medical education as consisting of two years training in human anatomy and physiology followed by two years of clinical work in a teaching hospital. In 1908, the CME asked the Carnegie Foundation for the Advancement of Teaching to survey American medical education, so as to promote the CME's reformist agenda and hasten the elimination of medical schools that failed to meet the CME's standards. The president of the Carnegie Foundation, Henry Pritchett, a staunch advocate of medical school reform, chose Flexner to conduct the survey.
At that time, the 155 medical schools in North America differed greatly in their curricula, methods of assessment, and requirements for admission and graduation. Flexner visited all 155 schools and generalized about them as follows: "Each day students were subjected to interminable lectures and recitations. After a long morning of dissection or a series of quiz sections, they might sit wearily in the afternoon through three or four or even five lectures delivered in methodical fashion by part-time teachers. Evenings were given over to reading and preparation for recitations. If fortunate enough to gain entrance to a hospital, they observed more than participated." The Report became notorious for its harsh description of certain establishments, for example describing Chicago's 14 medical schools as "a disgrace to the State whose laws permit its existence... indescribably foul... the plague spot of the nation."
Nevertheless, several schools received praise for excellent performance, including Harvard, Western Reserve, Michigan, Wake Forest University School of Medicine, McGill, University of Toronto, and especially Johns Hopkins - the latter was described as 'model for medical education'. [2]
Wake Forest University School of Medicine was praised for: "The laboratories of this little school are, as far as they go, models in their way. Everything about them indicates intelligence and earnestness. The dissecting room is clean and odorless, the bodies undergoing dissection being cared for in the most approved modern manner. Separate laboratories, properly equipped, are provided for ordinary undergraduate work in bacteriology, pathology, and histology, and the instructor has a private laboratory besides. Chemistry is taught in the well equipped college laboratory; physiology is slight; there is no pharmacology. There is a small museum; animals, charts, and books are provided." [3]
It should be noted that Wake Forest University School of Medicine, formerly Bowman Gray School of Medicine, opened a in a new town as a four-year school in 1941.
[edit] Recommended changes
When Flexner researched his report, many American medical schools were "proprietary", namely small trade schools owned by one or more doctors, unaffiliated with a college or university, and run to make a profit. A degree was typically awarded after only two years of study. Laboratory work and dissection were not necessarily required. Many of the instructors were local doctors teaching part-time, whose own training left something to be desired. The regulation of the medical profession by state government was minimal or nonexistent. American doctors varied enormously in their scientific understanding of human physiology, and the word "quack" flourished. There is no evidence that the mass of Americans were dissatisfied with this situation.
Flexner looked this situation in the face. Using the Johns Hopkins University School of Medicine as the ideal[4], he boldly recommended that:
* Admission to a medical school should require, at minimum, a high school diploma and at least two years of college or university study, primarily devoted to basic science. When Flexner researched his report, only 16 out of 155 medical schools in the United States and Canada required applicants to have completed two or more years of university education (p 28). According to Hiatt and Stockton, by 1920 92% of U.S. medical schools required this of applicants.
* The length of medical education be four years, and its content should be what the CME agreed to in 1905.
* Proprietary medical schools should either close or be incorporated into existing universities. Medical schools should be part of a larger university, because a proper stand-alone medical school would have to charge too much in order to break even.
Less known is Flexner's recommendation that medical schools appoint full-time clinical professors. Holders of these appointments would become "true university teachers, barred from all but charity practice, in the interest of teaching." Flexner pursued this objective for years, despite widespread opposition from existing medical faculty.
Flexner was the child of German immigrants, and had studied and traveled in Europe. He was well aware that one could not practice medicine in continental Europe without having undergone an extensive specialized university education. In effect, Flexner was demanding that American medical education conform to prevailing practice in continental Europe.
By and large, medical schools in Canada and the United States have followed Flexner's recommendations down to the present day. Recently, however, schools have increased their emphasis on public health matters.
[edit] Consequences of the report
To a remarkable extent, the following present-day aspects of the medical profession in North America are consequences of the Flexner Report:
* A physician receives at least six, and preferably eight, years of post-secondary formal instruction, nearly always in a university setting;
* Medical training adheres closely to the scientific method and is thoroughly grounded in human physiology and biochemistry. Medical research adheres fully to the protocols of scientific research;[5]
* Average physician quality has increased significantly;[6]
* No medical school can be created without the permission of the state government. Likewise, the size of existing medical schools is subject to state regulation;
* Each state branch of the American Medical Association has oversight over the conventional medical schools located within the state;
* Medicine in the USA and Canada becomes a highly paid and well-respected profession;
* The annual number of medical school graduates sharply declined, and the resulting reduction in the supply of doctors makes the availability and affordability of medical care problematic. The Report led to the closure of the sort of medical schools that trained doctors willing to charge their patients less. Moreover, before the Report, high quality doctors varied their fees according to what they believed their patients could afford, a practice known as price discrimination. The extent of price discrimination in American medicine declined in the aftermath of the Report;
* Kessel (1958) argued that the Flexner Report in effect began the cartelization of the American medical profession, a cartelization enforced by the American Medical Association and backed by the police power of each American state. This de facto cartel restricted the supply of physicians, and raised the incomes of the remaining practitioners.
The Report is now remembered because it succeeded in creating a single model of medical education, characterized by a philosophy that has largely survived to the present day. "An education in medicine," wrote Flexner, "involves both learning and learning how; the student cannot effectively know, unless he knows how." Although the report is more than 99 years old, many of its recommendations are still relevant—particularly those concerning the physician as a "social instrument... whose function is fast becoming social and preventive, rather than individual and curative."
[edit] Closure of many medical schools
According to Hiatt and Stockton (p. 8), Flexner sought to shrink the number of medical schools in the USA to 31, and to cut the annual number of medical graduates from 4,400 to 2,000. A majority of American institutions granting M.D. or D.O. degrees as of the date of the Report (1910) closed within two to three decades. (No Canadian medical school was deemed inadequate, and none closed or merged subsequent to the Report.) In 1904, there were 160 M.D. granting institutions with more than 28,000 students. By 1920, there were only 85 M.D. granting institution, educating only 13,800 students. By 1935, there were only 66 medical schools operating in the USA.
Between 1910 and 1935, more than half of all American medical schools merged or closed. This dramatic decline was in some part due to the implementation of the Report's recommendation that all "proprietary" schools be closed, and that medical schools should henceforth all be connected to universities. Of the 66 surviving M.D. granting institutions in 1935, 57 were part of a university. An important factor driving the mergers and closures of medical schools was that all state medical boards gradually adopted and enforced the Report's recommendations.
[edit] American medicine becomes a less diverse profession
One of the consequences of Flexner's advocacy of university-based medical education was that medical education became much more expensive, putting such education out of reach of all but upper class white males. The small "proprietary" schools Flexner condemned, which were contended to be have been based in generations-old folk traditions rather than relatively recent western science, did admit African-Americans, women, and students of limited financial means. These students usually could not afford six to eight years of university education, and were often simply denied admission to medical schools affiliated with universities. At the same time, the Report tended to delegitimize existing women doctors and doctors of color. While many such doctors continued to practice, usually within underserviced clienteles, they did so under proscribed circumstances and for less pay. In general, the standardization of medical education advocated in the Report led to the domination of American medicine by well-off white males. It also made it more difficult for people of color, residents of rural areas, and for those of limited means generally to obtain medical care in any form. The Flexner report recommended the closure of several African American medical schools, including the Leonard Medical Center, the oldest four-year medical school in the country, of any persuasion, not just for African-Americans. Ironically one of the schools was located in his own hometown of Louisville, Kentucky, Louisville National Medical College.
[edit] Impact on alternative medicine
When Flexner researched his report, "modern" medicine faced vigorous competition from several quarters, including osteopathic medicine, eclectic medicine, physiomedicalism, naturopathy and homeopathy. Flexner clearly doubted the scientific validity of all forms of medicine other than biomedicine, deeming any approach to medicine that did not advocate the use of treatments such as vaccines to prevent and cure illness as tantamount to quackery and charlatanism. Medical schools that offered training in various disciplines including eclectic medicine, physiomedicalism, naturopathy, and homeopathy, were told either to drop these courses from their curriculum or lose their accreditation and underwriting support. A few schools resisted for a time, but eventually all complied with the Report or shut their doors.[citation needed]
[edit] Impact on osteopathic medicine
Although almost all the alternative medical schools listed in Flexner's report were closed, the American Osteopathic Association (AOA) were able to bring a number of osteopathic medical schools into compliance with Flexner's recommendations. As a result, American osteopathic medical schools today teach from an evidence-based, medicalised, scientific knowledge base. The curricula of DO and MD awarding medical schools differ only minimally, the chief difference being the additional instruction in osteopathic schools of manipulative medicine. This dramatic convergence of osteopathic and biomedical training demonstrates the sweeping effect the Flexner report had, not only in the closure of inadequate schools, but also in the standardization of the curricula of surviving schools.
The Report (also called Carnegie Foundation Bulletin Number Four), called on American medical schools to enact higher admission and graduation standards, and to adhere strictly to the protocols of mainstream science in their teaching and research. Many American medical schools fell short of the standard advocated in the Report, and subsequent to its publication, nearly half of such schools merged or were closed outright. The Report also concluded that there were too many medical schools in the USA, and that too many doctors were being trained. A repercussion of the Flexner Report resulting from the closure or consolidation of university training, was reversion of American universities to male-only admittance programs to accommodate a smaller admission pool. Universities had begun opening and expanding female admissions as part of women's and co-educational facilities only in the mid-to-latter part of the 19th century with the founding of co-educational Oberlin College in 1833 and private colleges such as Vassar College and Pembroke College.
[edit] History
In 1904 the AMA created the Council on Medical Education (CME) whose objective was to restructure American medical education. At its first annual meeting, the CME adopted two standards: one laid down the minimum prior education required for admission to a medical school, the other defined a medical education as consisting of two years training in human anatomy and physiology followed by two years of clinical work in a teaching hospital. In 1908, the CME asked the Carnegie Foundation for the Advancement of Teaching to survey American medical education, so as to promote the CME's reformist agenda and hasten the elimination of medical schools that failed to meet the CME's standards. The president of the Carnegie Foundation, Henry Pritchett, a staunch advocate of medical school reform, chose Flexner to conduct the survey.
At that time, the 155 medical schools in North America differed greatly in their curricula, methods of assessment, and requirements for admission and graduation. Flexner visited all 155 schools and generalized about them as follows: "Each day students were subjected to interminable lectures and recitations. After a long morning of dissection or a series of quiz sections, they might sit wearily in the afternoon through three or four or even five lectures delivered in methodical fashion by part-time teachers. Evenings were given over to reading and preparation for recitations. If fortunate enough to gain entrance to a hospital, they observed more than participated." The Report became notorious for its harsh description of certain establishments, for example describing Chicago's 14 medical schools as "a disgrace to the State whose laws permit its existence... indescribably foul... the plague spot of the nation."
Nevertheless, several schools received praise for excellent performance, including Harvard, Western Reserve, Michigan, Wake Forest University School of Medicine, McGill, University of Toronto, and especially Johns Hopkins - the latter was described as 'model for medical education'. [2]
Wake Forest University School of Medicine was praised for: "The laboratories of this little school are, as far as they go, models in their way. Everything about them indicates intelligence and earnestness. The dissecting room is clean and odorless, the bodies undergoing dissection being cared for in the most approved modern manner. Separate laboratories, properly equipped, are provided for ordinary undergraduate work in bacteriology, pathology, and histology, and the instructor has a private laboratory besides. Chemistry is taught in the well equipped college laboratory; physiology is slight; there is no pharmacology. There is a small museum; animals, charts, and books are provided." [3]
It should be noted that Wake Forest University School of Medicine, formerly Bowman Gray School of Medicine, opened a in a new town as a four-year school in 1941.
[edit] Recommended changes
When Flexner researched his report, many American medical schools were "proprietary", namely small trade schools owned by one or more doctors, unaffiliated with a college or university, and run to make a profit. A degree was typically awarded after only two years of study. Laboratory work and dissection were not necessarily required. Many of the instructors were local doctors teaching part-time, whose own training left something to be desired. The regulation of the medical profession by state government was minimal or nonexistent. American doctors varied enormously in their scientific understanding of human physiology, and the word "quack" flourished. There is no evidence that the mass of Americans were dissatisfied with this situation.
Flexner looked this situation in the face. Using the Johns Hopkins University School of Medicine as the ideal[4], he boldly recommended that:
* Admission to a medical school should require, at minimum, a high school diploma and at least two years of college or university study, primarily devoted to basic science. When Flexner researched his report, only 16 out of 155 medical schools in the United States and Canada required applicants to have completed two or more years of university education (p 28). According to Hiatt and Stockton, by 1920 92% of U.S. medical schools required this of applicants.
* The length of medical education be four years, and its content should be what the CME agreed to in 1905.
* Proprietary medical schools should either close or be incorporated into existing universities. Medical schools should be part of a larger university, because a proper stand-alone medical school would have to charge too much in order to break even.
Less known is Flexner's recommendation that medical schools appoint full-time clinical professors. Holders of these appointments would become "true university teachers, barred from all but charity practice, in the interest of teaching." Flexner pursued this objective for years, despite widespread opposition from existing medical faculty.
Flexner was the child of German immigrants, and had studied and traveled in Europe. He was well aware that one could not practice medicine in continental Europe without having undergone an extensive specialized university education. In effect, Flexner was demanding that American medical education conform to prevailing practice in continental Europe.
By and large, medical schools in Canada and the United States have followed Flexner's recommendations down to the present day. Recently, however, schools have increased their emphasis on public health matters.
[edit] Consequences of the report
To a remarkable extent, the following present-day aspects of the medical profession in North America are consequences of the Flexner Report:
* A physician receives at least six, and preferably eight, years of post-secondary formal instruction, nearly always in a university setting;
* Medical training adheres closely to the scientific method and is thoroughly grounded in human physiology and biochemistry. Medical research adheres fully to the protocols of scientific research;[5]
* Average physician quality has increased significantly;[6]
* No medical school can be created without the permission of the state government. Likewise, the size of existing medical schools is subject to state regulation;
* Each state branch of the American Medical Association has oversight over the conventional medical schools located within the state;
* Medicine in the USA and Canada becomes a highly paid and well-respected profession;
* The annual number of medical school graduates sharply declined, and the resulting reduction in the supply of doctors makes the availability and affordability of medical care problematic. The Report led to the closure of the sort of medical schools that trained doctors willing to charge their patients less. Moreover, before the Report, high quality doctors varied their fees according to what they believed their patients could afford, a practice known as price discrimination. The extent of price discrimination in American medicine declined in the aftermath of the Report;
* Kessel (1958) argued that the Flexner Report in effect began the cartelization of the American medical profession, a cartelization enforced by the American Medical Association and backed by the police power of each American state. This de facto cartel restricted the supply of physicians, and raised the incomes of the remaining practitioners.
The Report is now remembered because it succeeded in creating a single model of medical education, characterized by a philosophy that has largely survived to the present day. "An education in medicine," wrote Flexner, "involves both learning and learning how; the student cannot effectively know, unless he knows how." Although the report is more than 99 years old, many of its recommendations are still relevant—particularly those concerning the physician as a "social instrument... whose function is fast becoming social and preventive, rather than individual and curative."
[edit] Closure of many medical schools
According to Hiatt and Stockton (p. 8), Flexner sought to shrink the number of medical schools in the USA to 31, and to cut the annual number of medical graduates from 4,400 to 2,000. A majority of American institutions granting M.D. or D.O. degrees as of the date of the Report (1910) closed within two to three decades. (No Canadian medical school was deemed inadequate, and none closed or merged subsequent to the Report.) In 1904, there were 160 M.D. granting institutions with more than 28,000 students. By 1920, there were only 85 M.D. granting institution, educating only 13,800 students. By 1935, there were only 66 medical schools operating in the USA.
Between 1910 and 1935, more than half of all American medical schools merged or closed. This dramatic decline was in some part due to the implementation of the Report's recommendation that all "proprietary" schools be closed, and that medical schools should henceforth all be connected to universities. Of the 66 surviving M.D. granting institutions in 1935, 57 were part of a university. An important factor driving the mergers and closures of medical schools was that all state medical boards gradually adopted and enforced the Report's recommendations.
[edit] American medicine becomes a less diverse profession
One of the consequences of Flexner's advocacy of university-based medical education was that medical education became much more expensive, putting such education out of reach of all but upper class white males. The small "proprietary" schools Flexner condemned, which were contended to be have been based in generations-old folk traditions rather than relatively recent western science, did admit African-Americans, women, and students of limited financial means. These students usually could not afford six to eight years of university education, and were often simply denied admission to medical schools affiliated with universities. At the same time, the Report tended to delegitimize existing women doctors and doctors of color. While many such doctors continued to practice, usually within underserviced clienteles, they did so under proscribed circumstances and for less pay. In general, the standardization of medical education advocated in the Report led to the domination of American medicine by well-off white males. It also made it more difficult for people of color, residents of rural areas, and for those of limited means generally to obtain medical care in any form. The Flexner report recommended the closure of several African American medical schools, including the Leonard Medical Center, the oldest four-year medical school in the country, of any persuasion, not just for African-Americans. Ironically one of the schools was located in his own hometown of Louisville, Kentucky, Louisville National Medical College.
[edit] Impact on alternative medicine
When Flexner researched his report, "modern" medicine faced vigorous competition from several quarters, including osteopathic medicine, eclectic medicine, physiomedicalism, naturopathy and homeopathy. Flexner clearly doubted the scientific validity of all forms of medicine other than biomedicine, deeming any approach to medicine that did not advocate the use of treatments such as vaccines to prevent and cure illness as tantamount to quackery and charlatanism. Medical schools that offered training in various disciplines including eclectic medicine, physiomedicalism, naturopathy, and homeopathy, were told either to drop these courses from their curriculum or lose their accreditation and underwriting support. A few schools resisted for a time, but eventually all complied with the Report or shut their doors.[citation needed]
[edit] Impact on osteopathic medicine
Although almost all the alternative medical schools listed in Flexner's report were closed, the American Osteopathic Association (AOA) were able to bring a number of osteopathic medical schools into compliance with Flexner's recommendations. As a result, American osteopathic medical schools today teach from an evidence-based, medicalised, scientific knowledge base. The curricula of DO and MD awarding medical schools differ only minimally, the chief difference being the additional instruction in osteopathic schools of manipulative medicine. This dramatic convergence of osteopathic and biomedical training demonstrates the sweeping effect the Flexner report had, not only in the closure of inadequate schools, but also in the standardization of the curricula of surviving schools.
Thursday, September 2, 2010
yale address
Yale Medical School Graduation Address
Donald M. Berwick, MD, MPP
New Haven, Connecticut: May 24, 2010
Dean Alpern, Faculty, Families, Friends, and Honored Graduates...
I don‟t have words enough to express my gratitude for the chance to speak with you on your special day. It would be a pleasure and honor at any graduation ceremony. But, I have to tell you, to be up here in this role in the presence of my own daughter on the day that she becomes a doctor is a joy I wouldn‟t dare have dreamed up. I hope that each of you will someday have the chance to feel as much gratitude and pride and love as I feel right now, joining you, and, especially, joining Jessica. Thank you very much. I am so proud of you, Jessica.
Now, I have to tell you the truth about Jessica. Jessica was supposed to be a boy. At least that‟s what the ultrasonographer said when we took a look at “him” in utero. “Never been wrong,” said the ultrasound tech as she pointed out the anatomy – there was the “thing.” My wife and I were delighted. We saw the thing, too. Clearly. We had two sons already, and they were fantastic. A third boy – terrific!
But, you know, to be honest, and with no offense intended to Ben and Dan, who are here today, too, we were sort of hoping for a change. I had only brothers, and Ann, my wife, I knew, wanted a chance to raise a daughter. To our friends we said, “Boy… Girl…We don‟t care; just as long as he is healthy.” But… we were lying, just a little.
And then: the surprise. I was right there, in the c-section room – Ann delivered all four of our children by c-section – and, instead of Jonas, whom we were waiting for, out popped, not Jonas, but Jessica. “Oh, my goodness,” the obstetrician exclaimed, “it‟s a girl!” Imagine the joy – Ann and I literally squealed. We screamed. “A daughter,” Ann screamed, “a daughter. We have a daughter!”
The obstetrician said, “Hmmmm…. That never happened before. That „thing‟ on the ultrasound must have been the umbilical cord.” Whatever. No question at all – that was one of the peak moments of my entire life. I will never, ever forget it. I had a daughter.
How do I know that moment of miracle – that surprise and celebration? Well, it‟s obvious. I told you. I was there – I was right there in the c-section room, holding my wife‟s hand. Greeting my new, unexpected daughter. Watching the miracle.
Maybe you know this; maybe you don‟t. But, if that had happened 20 years before Jessica was born, or even 10, I would have missed it. I wouldn‟t have been there. I couldn’t have been there, because fathers weren‟t allowed in c-section rooms. We weren‟t supposed to be there. That was the rule. Then, somebody changed the rule; somebody courageous, I suspect. And, so, I got to see a miracle.
Let me read to you an email I received on Thursday, December 19, 2009. It came from Mrs. Jocelyn Anne Gruzenski – she goes by “Jackie.” I did not know Jackie Gruzenski at the time; she wrote to me out of the blue. But I have since connected with her. And, she gave me permission to read her email to me to you. Here‟s what she wrote:
“Dr. Berwick, …
“My husband was Dr. William Paul Gruzenski, a psychiatrist for 39 years. He was admitted to (a hospital she names in Pennsylvania) after developing a cerebral bleed with a hypertensive crisis. My issue is that I was denied access to my husband except for very strict visiting, four times a day for 30 minutes, and that my husband was hospitalized behind a locked door. My husband and I were rarely separated except for work,” she wrote. “He wanted me present in the ICU, and he challenged the ICU nurse and MD saying, „She is not a visitor, she is my wife.‟ But, it made no difference. My husband was in the ICU for eight days out of his last 16 days alive, and there were a lot of missed opportunities for us.”
Mrs. Gruzenski continued: “I am advocating to the hospital administration that visiting hours have to be open especially for spouses… I do not feel that his care was individualized to meet his needs; he wanted me there more than I was allowed. I feel it was a very cruel thing that was done to us…”
Listen, again, to the words of Dr. Gruzenski: “She is not a visitor; she is my wife.” Hear, again, Mrs. Gruzenski: “I feel that it was a very cruel thing that was done to us.”
“Cruel” is a powerful word for Mrs. Gruzenski to use, isn‟t it? Her email and the emails that followed that first one are without exception dignified, respectful, tempered. Why does she say, “cruel”?
We will have to imagine ourselves there. “My husband and I loved each other very deeply,” she writes to me, “and we wanted to share our last days and moments together. We both knew the gravity of his illness, and my husband wanted quality of life, not quantity.”
What might a husband and wife of 19 years, aware of the short time left together, wish to talk about – wish to do – in the last days? I don‟t know for Dr. and Mrs. Gruzenski. But, I do know for me. I would talk about our children. I would talk about the best trip we ever took together, and even argue, smiling, about whose idea it was. I would remember the black bear we met in a clearing in the Wrangell-St. Elias Range; the cabin at Assiniboine; the Jøtenheim mountains of Norway. I would remember being lost in Kyoto and lost in Prague and lost on Mount Washington, and always found again. Mushroom soup at Café Budapest. And seeing Jessica born, and Ben, and Dan, and Becca. We would have so much to talk about. So much. The nurses would pad in and out of the hospital room, checking i.v.s and measuring pulses and planning their dinners and their weekends. And none of what the nurses and doctors did would matter to us at all; we wouldn‟t even notice them. We would know exactly who the visitors were – they, the doctors and the nurses. They, they would be the visitors in this tiny corner of our whole lives together – they, not us. In the John Denver song it goes this way, “… and all the time that you‟re with me, we will be at home.”
Someone stole all of that from Dr. and Mrs. Gruzenski. A nameless someone. I suspect an unknowing someone. Someone who did not understand who was at home and who was the guest – who was the intruder. Someone who forgot about the black bear and the best mushroom soup we ever had – the jewels of shared experience that glimmer with meaning in our lives. Someone who put the i.v. first, and the soul second.
Of course, it isn‟t really “someone” at all. We don‟t even know who, or what it is. Its voice sounds rational. Its words are these: “It is our policy,” “It‟s against the rule,” “It would be a problem,” and even, incredibly, “It is in your own best interest.” What is irrational is not those phrases; they seem to make sense. What is irrational is what follows those phrases, in ellipsis, unsaid: “It is our policy … that you cannot hold your husband‟s hand.” “It is against the rules … to let you see this or to let you know this.” “It would be a problem … if we treated you on your own terms not ours.” “It is in your own best interest … to miss your daughter‟s moment of birth.” This is the voice of power; and power does not always think the whole thing through.
Berwick Yale Medical School Graduation Address, May 2010 5
Even when it has no name and no locus, power can be, to borrow Mrs. Gruzenski‟s word, “cruel.”
I want you to celebrate this day. I want you to experience all of the pride, all of the joy that it brings you to have reached this milestone. I am not telling you Dr. and Mrs. Gruzenski‟s story to sadden you. I am telling it to inspire you. I want you to remember it, if you can possibly remember anything I am saying to you at this chock-full moment of your lives, because that story gives you a choice.
You see, today you take a big step into power. With your white coat and your Latin, with your anatomy lessons and your stethoscope, you enter today a life of new and vast privilege. You may not notice your power at first. You will not always feel powerful or privileged – not when you are filling out endless billing forms and swallowing requirements and struggling through hard days of too many tasks. But this will be true: In return for your years of learning and your dedication to a life of service and your willingness to take an oath to that duty, society will give you access and rights that it gives to no one else. Society will allow you to hear secrets from frightened human beings that they are too scared to tell anyone else. Society will permit you to use drugs and instruments that can do great harm as well as great good, and that in the hands of others would be weapons. Society will give you special titles and spaces of privilege, as if you were priests. Society will let you build walls and write rules.
And in that role, with that power, you will meet Dr. and Mrs. Gruzenski over, and over, and over again. You will meet them every day – every hour. They will be in disguise. They will be disguised as a new mother afraid to touch her preemie on the ventilator in the incubator. Disguised as the construction worker too embarrassed to admit that he didn‟t hear a word you just said after, “It might be cancer.” Disguised as the busy lawyer who cannot afford for you to keep her waiting, but too polite to say so. Disguised at the alcoholic bottoming out who was the handsome champion of his soccer team and dreamed of being an architect someday. Disguised as the child over whom you tower. Disguised as the 90-year-old grandmother, over whom you tower. Disguised as the professor in the MRI machine who has been told to lie still, but who desperately needs to urinate and is ashamed. Disguised as the man who would prefer to know; and as the man who would prefer not to know. Disguised as the woman who would prefer to sit; and as the woman who would prefer to stand. And as the man who wants you to call him, “Bill,” and as the man who prefers to be called, “Dr. Gruzenski.”
Mrs. Gruzenski wrote, “My husband was a very caring physician and administrator for many years, but during his hospitalization, he was not even afforded the respect of being called, „Doctor.‟” Dr. Gruzenski wanted to be called, “Dr. Gruzenski.” But, they did not do so.
You can. That choice is not in the hands of nameless power, not fated to control by deaf habit. Not “our policy,” “the rule.” Just you. Your choice. Your rule. Your power.
What is at stake here may seem a small thing in the face of the enormous health care world you have joined. It is as a nickel to the $2.6 trillion industry. But that small thing is what matters. I will tell you: it is all that matters. All that matters is the person. The person. The individual. The patient. The poet. The lover. The adventurer. The frightened soul. The wondering mind. The learned mind. The Husband. The Wife. The Son. The Daughter. In the moment.
In the moment, it is all about choice. You have a magical opportunity. You have the opportunity to decide. Yes, you can read the rule book; and someday you can even write the rule book. Decide. Yes, you can hide behind the protocols and the policies. Decide. Yes, you can
say “we,” when you mean, “I.” Yes, you can lock the door. “Sorry, Mrs. Gruzenski, your 30 minutes are up.” You can say that.
But, you can also unlock the door. You can ask, “Shall I call you “Dr. Gruzenski”? “Would you like to be alone?” “Is this a convenient time?” “Is there something else I can do for you?” You can say, “You‟re the boss.” You can say, “Tell me about the best trip you ever took. Tell me about the time you saw your daughter born.”
In my first week of medical school, I was assigned a tutor: Dr. Edward Frank. He was a vascular surgeon, and he was to supervise me in my physical diagnosis course. I read what Harvard Medical School called, “The Red Book.” It was all about the history and physical exam. Hundreds of questions to ask – history, physical, chief complaint, review of systems, and on and on. I stayed up very late, studying all those questions; memorizing the ritual. I knew all the right questions, I thought. I met Dr. Frank the next afternoon, and he took me to see Mrs. Goldberg, who was in the hospital to have her gall bladder taken out. Dr. Frank brought me into Mrs. Goldberg‟s room, into her presence, introduced me, and invited me to begin. My very first history and physical.
“Tell me, Mrs. Goldberg,” I said, “when did your pain begin?” Dr. Frank, the surgeon, interrupted me. He gently put his hand on my shoulder, and he gave me a gift I will never, ever forget. And I will pass his gift to you. His gift was a question that The Red Book left out.
“Oh, Don,” he said. “Before you ask that, let me tell you something very special. Did you know that Mrs. Goldberg has a brand new grandson?”
Decide. You can read the rules. Or, you can say, “Pardon me.” “Pardon this unwelcome interruption in your lives. Thank you for inviting me to help. Thank you for letting me visit. I
Berwick Yale Medical School Graduation Address, May 2010 8
am your guest, and I know it. Now, please, Mrs. Gruzenski, Dr. Gruzenski, what may I do for you?”
Congratulations on your achievement today. Feel proud. You ought to. When you put on your white coat, my dear friends, you become a doctor.
But, now I will tell you a secret – a mystery. Those who suffer need you to be something more than a doctor; they need you to be a healer. And, to become a healer, you must do something even more difficult than putting your white coat on. You must take your white coat off. You must recover, embrace, and treasure the memory of your shared, frail humanity – of the dignity in each and every soul. When you take off that white coat in the sacred presence of those for whom you will care – in the sacred presence of people just like you – when you take off that white coat, and, tower not over them, but join those you serve, you become a healer in a world of fear and fragmentation, an “aching” world, as your Chaplain put it this morning, that has never needed healing more.
Congratulations.
Donald M. Berwick, MD, MPP
New Haven, Connecticut: May 24, 2010
Dean Alpern, Faculty, Families, Friends, and Honored Graduates...
I don‟t have words enough to express my gratitude for the chance to speak with you on your special day. It would be a pleasure and honor at any graduation ceremony. But, I have to tell you, to be up here in this role in the presence of my own daughter on the day that she becomes a doctor is a joy I wouldn‟t dare have dreamed up. I hope that each of you will someday have the chance to feel as much gratitude and pride and love as I feel right now, joining you, and, especially, joining Jessica. Thank you very much. I am so proud of you, Jessica.
Now, I have to tell you the truth about Jessica. Jessica was supposed to be a boy. At least that‟s what the ultrasonographer said when we took a look at “him” in utero. “Never been wrong,” said the ultrasound tech as she pointed out the anatomy – there was the “thing.” My wife and I were delighted. We saw the thing, too. Clearly. We had two sons already, and they were fantastic. A third boy – terrific!
But, you know, to be honest, and with no offense intended to Ben and Dan, who are here today, too, we were sort of hoping for a change. I had only brothers, and Ann, my wife, I knew, wanted a chance to raise a daughter. To our friends we said, “Boy… Girl…We don‟t care; just as long as he is healthy.” But… we were lying, just a little.
And then: the surprise. I was right there, in the c-section room – Ann delivered all four of our children by c-section – and, instead of Jonas, whom we were waiting for, out popped, not Jonas, but Jessica. “Oh, my goodness,” the obstetrician exclaimed, “it‟s a girl!” Imagine the joy – Ann and I literally squealed. We screamed. “A daughter,” Ann screamed, “a daughter. We have a daughter!”
The obstetrician said, “Hmmmm…. That never happened before. That „thing‟ on the ultrasound must have been the umbilical cord.” Whatever. No question at all – that was one of the peak moments of my entire life. I will never, ever forget it. I had a daughter.
How do I know that moment of miracle – that surprise and celebration? Well, it‟s obvious. I told you. I was there – I was right there in the c-section room, holding my wife‟s hand. Greeting my new, unexpected daughter. Watching the miracle.
Maybe you know this; maybe you don‟t. But, if that had happened 20 years before Jessica was born, or even 10, I would have missed it. I wouldn‟t have been there. I couldn’t have been there, because fathers weren‟t allowed in c-section rooms. We weren‟t supposed to be there. That was the rule. Then, somebody changed the rule; somebody courageous, I suspect. And, so, I got to see a miracle.
Let me read to you an email I received on Thursday, December 19, 2009. It came from Mrs. Jocelyn Anne Gruzenski – she goes by “Jackie.” I did not know Jackie Gruzenski at the time; she wrote to me out of the blue. But I have since connected with her. And, she gave me permission to read her email to me to you. Here‟s what she wrote:
“Dr. Berwick, …
“My husband was Dr. William Paul Gruzenski, a psychiatrist for 39 years. He was admitted to (a hospital she names in Pennsylvania) after developing a cerebral bleed with a hypertensive crisis. My issue is that I was denied access to my husband except for very strict visiting, four times a day for 30 minutes, and that my husband was hospitalized behind a locked door. My husband and I were rarely separated except for work,” she wrote. “He wanted me present in the ICU, and he challenged the ICU nurse and MD saying, „She is not a visitor, she is my wife.‟ But, it made no difference. My husband was in the ICU for eight days out of his last 16 days alive, and there were a lot of missed opportunities for us.”
Mrs. Gruzenski continued: “I am advocating to the hospital administration that visiting hours have to be open especially for spouses… I do not feel that his care was individualized to meet his needs; he wanted me there more than I was allowed. I feel it was a very cruel thing that was done to us…”
Listen, again, to the words of Dr. Gruzenski: “She is not a visitor; she is my wife.” Hear, again, Mrs. Gruzenski: “I feel that it was a very cruel thing that was done to us.”
“Cruel” is a powerful word for Mrs. Gruzenski to use, isn‟t it? Her email and the emails that followed that first one are without exception dignified, respectful, tempered. Why does she say, “cruel”?
We will have to imagine ourselves there. “My husband and I loved each other very deeply,” she writes to me, “and we wanted to share our last days and moments together. We both knew the gravity of his illness, and my husband wanted quality of life, not quantity.”
What might a husband and wife of 19 years, aware of the short time left together, wish to talk about – wish to do – in the last days? I don‟t know for Dr. and Mrs. Gruzenski. But, I do know for me. I would talk about our children. I would talk about the best trip we ever took together, and even argue, smiling, about whose idea it was. I would remember the black bear we met in a clearing in the Wrangell-St. Elias Range; the cabin at Assiniboine; the Jøtenheim mountains of Norway. I would remember being lost in Kyoto and lost in Prague and lost on Mount Washington, and always found again. Mushroom soup at Café Budapest. And seeing Jessica born, and Ben, and Dan, and Becca. We would have so much to talk about. So much. The nurses would pad in and out of the hospital room, checking i.v.s and measuring pulses and planning their dinners and their weekends. And none of what the nurses and doctors did would matter to us at all; we wouldn‟t even notice them. We would know exactly who the visitors were – they, the doctors and the nurses. They, they would be the visitors in this tiny corner of our whole lives together – they, not us. In the John Denver song it goes this way, “… and all the time that you‟re with me, we will be at home.”
Someone stole all of that from Dr. and Mrs. Gruzenski. A nameless someone. I suspect an unknowing someone. Someone who did not understand who was at home and who was the guest – who was the intruder. Someone who forgot about the black bear and the best mushroom soup we ever had – the jewels of shared experience that glimmer with meaning in our lives. Someone who put the i.v. first, and the soul second.
Of course, it isn‟t really “someone” at all. We don‟t even know who, or what it is. Its voice sounds rational. Its words are these: “It is our policy,” “It‟s against the rule,” “It would be a problem,” and even, incredibly, “It is in your own best interest.” What is irrational is not those phrases; they seem to make sense. What is irrational is what follows those phrases, in ellipsis, unsaid: “It is our policy … that you cannot hold your husband‟s hand.” “It is against the rules … to let you see this or to let you know this.” “It would be a problem … if we treated you on your own terms not ours.” “It is in your own best interest … to miss your daughter‟s moment of birth.” This is the voice of power; and power does not always think the whole thing through.
Berwick Yale Medical School Graduation Address, May 2010 5
Even when it has no name and no locus, power can be, to borrow Mrs. Gruzenski‟s word, “cruel.”
I want you to celebrate this day. I want you to experience all of the pride, all of the joy that it brings you to have reached this milestone. I am not telling you Dr. and Mrs. Gruzenski‟s story to sadden you. I am telling it to inspire you. I want you to remember it, if you can possibly remember anything I am saying to you at this chock-full moment of your lives, because that story gives you a choice.
You see, today you take a big step into power. With your white coat and your Latin, with your anatomy lessons and your stethoscope, you enter today a life of new and vast privilege. You may not notice your power at first. You will not always feel powerful or privileged – not when you are filling out endless billing forms and swallowing requirements and struggling through hard days of too many tasks. But this will be true: In return for your years of learning and your dedication to a life of service and your willingness to take an oath to that duty, society will give you access and rights that it gives to no one else. Society will allow you to hear secrets from frightened human beings that they are too scared to tell anyone else. Society will permit you to use drugs and instruments that can do great harm as well as great good, and that in the hands of others would be weapons. Society will give you special titles and spaces of privilege, as if you were priests. Society will let you build walls and write rules.
And in that role, with that power, you will meet Dr. and Mrs. Gruzenski over, and over, and over again. You will meet them every day – every hour. They will be in disguise. They will be disguised as a new mother afraid to touch her preemie on the ventilator in the incubator. Disguised as the construction worker too embarrassed to admit that he didn‟t hear a word you just said after, “It might be cancer.” Disguised as the busy lawyer who cannot afford for you to keep her waiting, but too polite to say so. Disguised at the alcoholic bottoming out who was the handsome champion of his soccer team and dreamed of being an architect someday. Disguised as the child over whom you tower. Disguised as the 90-year-old grandmother, over whom you tower. Disguised as the professor in the MRI machine who has been told to lie still, but who desperately needs to urinate and is ashamed. Disguised as the man who would prefer to know; and as the man who would prefer not to know. Disguised as the woman who would prefer to sit; and as the woman who would prefer to stand. And as the man who wants you to call him, “Bill,” and as the man who prefers to be called, “Dr. Gruzenski.”
Mrs. Gruzenski wrote, “My husband was a very caring physician and administrator for many years, but during his hospitalization, he was not even afforded the respect of being called, „Doctor.‟” Dr. Gruzenski wanted to be called, “Dr. Gruzenski.” But, they did not do so.
You can. That choice is not in the hands of nameless power, not fated to control by deaf habit. Not “our policy,” “the rule.” Just you. Your choice. Your rule. Your power.
What is at stake here may seem a small thing in the face of the enormous health care world you have joined. It is as a nickel to the $2.6 trillion industry. But that small thing is what matters. I will tell you: it is all that matters. All that matters is the person. The person. The individual. The patient. The poet. The lover. The adventurer. The frightened soul. The wondering mind. The learned mind. The Husband. The Wife. The Son. The Daughter. In the moment.
In the moment, it is all about choice. You have a magical opportunity. You have the opportunity to decide. Yes, you can read the rule book; and someday you can even write the rule book. Decide. Yes, you can hide behind the protocols and the policies. Decide. Yes, you can
say “we,” when you mean, “I.” Yes, you can lock the door. “Sorry, Mrs. Gruzenski, your 30 minutes are up.” You can say that.
But, you can also unlock the door. You can ask, “Shall I call you “Dr. Gruzenski”? “Would you like to be alone?” “Is this a convenient time?” “Is there something else I can do for you?” You can say, “You‟re the boss.” You can say, “Tell me about the best trip you ever took. Tell me about the time you saw your daughter born.”
In my first week of medical school, I was assigned a tutor: Dr. Edward Frank. He was a vascular surgeon, and he was to supervise me in my physical diagnosis course. I read what Harvard Medical School called, “The Red Book.” It was all about the history and physical exam. Hundreds of questions to ask – history, physical, chief complaint, review of systems, and on and on. I stayed up very late, studying all those questions; memorizing the ritual. I knew all the right questions, I thought. I met Dr. Frank the next afternoon, and he took me to see Mrs. Goldberg, who was in the hospital to have her gall bladder taken out. Dr. Frank brought me into Mrs. Goldberg‟s room, into her presence, introduced me, and invited me to begin. My very first history and physical.
“Tell me, Mrs. Goldberg,” I said, “when did your pain begin?” Dr. Frank, the surgeon, interrupted me. He gently put his hand on my shoulder, and he gave me a gift I will never, ever forget. And I will pass his gift to you. His gift was a question that The Red Book left out.
“Oh, Don,” he said. “Before you ask that, let me tell you something very special. Did you know that Mrs. Goldberg has a brand new grandson?”
Decide. You can read the rules. Or, you can say, “Pardon me.” “Pardon this unwelcome interruption in your lives. Thank you for inviting me to help. Thank you for letting me visit. I
Berwick Yale Medical School Graduation Address, May 2010 8
am your guest, and I know it. Now, please, Mrs. Gruzenski, Dr. Gruzenski, what may I do for you?”
Congratulations on your achievement today. Feel proud. You ought to. When you put on your white coat, my dear friends, you become a doctor.
But, now I will tell you a secret – a mystery. Those who suffer need you to be something more than a doctor; they need you to be a healer. And, to become a healer, you must do something even more difficult than putting your white coat on. You must take your white coat off. You must recover, embrace, and treasure the memory of your shared, frail humanity – of the dignity in each and every soul. When you take off that white coat in the sacred presence of those for whom you will care – in the sacred presence of people just like you – when you take off that white coat, and, tower not over them, but join those you serve, you become a healer in a world of fear and fragmentation, an “aching” world, as your Chaplain put it this morning, that has never needed healing more.
Congratulations.
Wednesday, January 13, 2010
Words used in the Rules shall be read as the masculine or feminine gender, and as the singular or plural, as the context requires. The captions or headings in the Rules are for convenience only and are not intended to limit or define the scope or effect of any provision of the Rules.
I. ADMISSION OF PATIENTS
1.1 Limitations: A Member with appropriate privileges may admit, consult and treat patients suffering from all types of diseases, except where adequate facilities and personnel are not available. The CEO or Medical Director of the Hospital may determine exceptions.
1.2 Admitting Privileges: Patients requiring admission may be admitted only by Members with admitting privileges. Up-to-date lists of the Staff are maintained by Medical Staff Services in the Star and Medical Staff Computer Systems.
1.3 Assignment of Patients to Physicians: Patients requiring admission through the Emergency Department who have no personal physician will be assigned to the “on-call” physician in a particular specialty based upon patient care need. The Emergency Department attending physician will make that determination regarding specialty need.
1.4 Provisional Diagnosis: No patient shall be admitted to the Hospital until a provisional diagnosis has been reported to the Registration Staff.
1.5 Psychiatric Admissions: Any Member with admitting privileges at the Hospital can admit to the Behavioral Services areas. The attending physician or the consulting psychiatrist must attend the scheduled weekly clinical staffing on the Adult Unit. All patients must have a psychiatric consultation within 24 hours of admission to inpatient Behavioral Services.
All patients transferred or admitted to Behavioral Services must be medically stable and have a primary psychiatric diagnosis stated in their medical records.
1.6 Physician Responsibility for Providing Information: Physicians admitting patients will be responsible for providing information for the protection of other patients and staff from those who are a source of danger or for protection of the patient from self-inflicted harm. Isolation or other special precautions will be ordered as appropriate and in accordance with the Hospital Infection Control and Isolation Manual.
1.7 Physician Transfer of Responsibility: The patient’s admitting physician is regarded as being in complete charge of the patient’s overall care until he orders transfer of that responsibility and it is accepted by another physician. Documentation of this transfer and acceptance of responsibility must be apparent in the physician’s orders or progress notes.
1.8 Attending Physician Responsibility: The attending physician, or such physician’s designee, will be required to personally visit a patient admitted to the Hospital within an appropriate time frame based upon the patient’s condition, never to exceed twelve (12) hours after order for admit is written or sooner as dictated by the patient’s medical condition; provided, however, for normal newborns and rehabilitation cases, or if the patient was seen by the admitting doctor within 12 hours before the admission and there is appropriate documentation and orders for the chart, the attending physician’s visit must occur within twenty-four (24) hours of admission. Thereafter, the attending physician, or other designated physician, including a consultant, will visit the patient every day during the remainder of the patient’s hospitalization. Patients admitted to the one of the critical care areas must be seen within two (2) hours of admission.
Summary: Initial admission assessment – 12 hours except:
normal newborns or rehabilitation – 24 hours
ICU – 2 hours
If patient seen by admitting doctor in the office within 12 hours
before
Daily visit by attending or designated physician
Consultations – within 24 hours after notification
1.9 Observation status requires that the patient meet criteria and a written order by the physician. Case Management or the Nursing Staff will contact the physician whose patient is approaching the 24-hour threshold in observation to determine the appropriate patient status and update information and orders. (Refer to Hospital Policy # 3002)
1.10 Transfer to or from the Kaiser Rehabilitation shall be considered a new admission. If the history and physical was dictated within 30 days, the physician shall write an addendum updating the patient’s condition. The acute hospital discharge summary will not suffice because it does not contain the required elements of a history and physical.
II. CONSENTS
2.1 The Hospital will secure a general hospital and medical consent from the patient or the patient’s legal representative or agent at the time of admission, or as soon as reasonably possible thereafter. Each patient’s medical record shall contain evidence of such general consent for treatment during hospitalization. The attending physician is responsible for obtaining informed consent for treatment.
2.2 Informed Consent: A written, signed, informed consent will be obtained prior to surgery or any other invasive procedure, except in emergencies and suitable signatures cannot be obtained due to the condition of the patient. In emergencies involving a minor or unconscious patient, in which consent for surgery cannot be obtained immediately from patients, personal representative or next of kin, those circumstances should be fully documented in the patient’s medical record. A consultation in such instances is advisable, if time permits, before the emergency surgery is undertaken. If more than one procedure is performed and another procedure is done by a different physician, then a separate consent must be obtained for each procedure. Surgeons are required to use language understandable to a patient when obtaining a consent for surgery. No abbreviations may be used in the consent. The practitioner shall document evidence on the informed consent of potential risk and benefits of the procedure(s) and any feasible alternative. A copy of the signed consent must be put in the patient’s medical record before surgery except in emergencies.
2.3 Organized Health Care Agreement: The Hospital and the Members of the Staff constitute an organized health care arrangement (OHCA) to allow the exchange of Protected Health Information for treatment, payment and healthcare operations of the OHCA. The terms “organized health care arrangement” and “Protected Health Information” shall have the meanings set forth in the Health Insurance Portability and Accountability Act (“HIPAA”). The OHCA participants provide services to mutual patients in a clinically integrated care setting and the sharing of such information benefits the common enterprise by allowing the participants to improve their joint operations and further quality patient care. The OCHA participants agree to abide by the terms of the joint Notice of Privacy Practices provided to patients of the Hospital. Each participant remains responsible for individual HIPAA compliance efforts. The OHCA does not mean that any participant is responsible for the violations of another participant.
III. CONSULTATIONS
3.1 If an attending physician determines that a consultation is necessary, he may request it. In any case of serious illness, in which the diagnosis is obscure, or when there is doubt as to the best therapeutic measures to be utilized, consultation should be sought by the attending physician. Request should be written and in addition the
consultant must be notified by direct physician to physician communication. The consultant physician may authorize other licensed personnel under their supervision may be notified. After discussion with the attending physician, the consultant may then order additional consultations.
3.2 The consultant shall have the obligation to see the patient in a timely fashion based upon the patient’s severity of illness, not to exceed 24 hours after notification. Consultants participating in active management of a case must visit the patient and document those visits in the patient’s medical record.
3.3 For surgical procedures, a consultative note will be recorded in the patient’s medical record prior to the operative procedure except in an emergency where unnecessary delay could threaten the life or well-being of the patient.
3.4 All patients admitted to a Critical Care area, except for those patients being actively managed by a Cardiologist or Surgeon, in his area of expertise, must be seen on a consultative basis by a critical care specialist. Consultation with the attending physician will follow. Consultation by the critical care specialist is required on all patients on a ventilator, except those post surgical patients awaiting routine post anesthesia extubation.
IV. DEATHS
4.1 Autopsies: Hospital encourages physicians to secure autopsies whenever appropriate. No autopsy shall be performed without written consent of the deceased’s personal representative, except for medical examiner cases. The policy of the Hospital is to perform post mortem examinations in deaths that meet criteria for autopsy. (Refer to Hospital Policy # 2018)
V. DISCHARGE
5.1 Patients will be discharged only on order of the attending physician or his designee. At the time of discharge, when possible, the attending physician or designee shall determine that the patient’s medical record is complete, state his final diagnosis, a complete list of all medications that the patient will be on upon discharge, and sign the record. Physicians should be aware of Rule 9.12, which requires that records of patients be completed within 30 days following discharge.
5.2 The discharge summary should concisely recapitulate the diagnosis and reason for hospitalization, the significant findings, the procedure performed and the treatment rendered, the condition of the patient on discharge, and all specific instructions given to the patient’s family or personal representative including medications that the patient will be on upon discharge.
5.3 The discharge summary shall be transcribed to insure legibility. Only the attending physician, resident and authorized allied health professional will be allowed to dictate discharge summaries.
5.4 A handwritten discharge summary may be used on stays less than 48 hours. Hospital form # 3806 should be used in these cases. All information in § 5.2 should be included.
5.5 The discharge diagnosis should be written on the progress notes or discharge instruction sheet.
5.6 A final progress note may be written in lieu of the discharge summary in cases of normal newborn infants and uncomplicated obstetrical deliveries, when the patient is hospitalized for less than 48 hours, with minor problems. The final note should include any instructions given to the patient and personal representatives.
5.7 All teaching cases must have a dictated/transcribed discharge summary with the exception of normal newborn and uncomplicated delivery charts and stays less than 48 hours. If dictated by a resident or authorized allied health professional, the discharge summary must be countersigned by the attending physician.
5.8 A death summary must be dictated on all death cases stating the reason for admission, the findings and course in the Hospital, and the events leading to the death.
VI. EMERGENCY COVERAGE/DEPARTMENT
6.1 A medical record will be kept on every patient who presents at the Emergency Department (“ED”). The emergency record will contain, as appropriate, patient identification, history of disease or injury, physical findings, laboratory and radiological reports, if any, diagnosis, determination of whether or not there was an emergency medical condition, record of treatment, disposition of the case, and signature of the physician rendering the service. A copy of the report of treatment will be made available to the patient’s primary care physician, if known.
6.2 The ED attending physician will make the decision regarding which surgical specialty physician to call for trauma patients with significant injuries.
6.3 All Active and Provisional Active Staff Members shall, and Courtesy Staff Members may be required to, provide on-call emergency department coverage for unassigned patients in their area of expertise. On-call physicians will be expected to respond by phone within 20 minutes and to be physically present, if warranted, within 30 minutes of the phone call or sooner if clinically indicated. The Chief of each Department will furnish to the Medical Staff Services Department a roster of physicians who are scheduled to provide emergency call on a monthly basis. If a specific specialty or subspecialty is not available for complete coverage for the ED call schedule, then the
Medical Staff Services Department will schedule ED coverage in those specialties and subspecialties to the extent feasible.
When the on-call physician cannot respond in a timely manner because of a situation beyond his control, or when a specific specialist or subspecialist is not available, the ED will, when appropriate, transfer the patient in accordance with the Hospital’s Emergency Screening, Stabilization and Transfer Policy. If an emergency exists, and the patient’s attending physician or his designated substitute physician is not available, the President of the Staff, the Medical Director or the Chief of the appropriate Department shall assign a qualified Member to assume the care of the patient until the patient’s physician is available.
6.4 If the ED is unable to reach the physician on call, the ED physician may at his discretion contact another Member with the appropriate privileges. The assigned physician shall be notified and shall determine management of the patient. The patient will be directed to the assigned physician for follow-up care. The ED physician determines management of the patient, unless admission or care beyond the usual level provided in the ED is needed.
VII. HOSPITAL POLICIES
All Hospital Policies and Procedures are available in the Medical Staff Services offices, and are available to all Members and allied health professionals. These Policies are also located on each Nursing Unit and within the Hospital Departments.
VIII. INSTITUTIONAL REVIEW BOARD
The Institutional Review Board (“IRB”) shall serve as the review body for all in-patient investigation drugs, devices and procedures. The IRB also reviews outpatient studies submitted for consideration. The primary purpose of the IRB is the protection of human subjects enrolled in research studies and clinical trials. The IRB makes periodic reports to the Clinical Quality, Professional Affairs, Medical Executive, and Board of Trustees committees.
IX. MEDICAL RECORDS
9.1 A medical record shall be maintained for every patient who is evaluated or treated at the Hospital as an inpatient, outpatient or
emergency patient, or who receives patient care services in any Hospital administered program.
9.2 All significant clinical information pertaining to the patient shall be incorporated in the patient’s medical record. The medical record shall contain sufficient information to:
· Identify the patient
· Reflect the diagnosis
· Give results of diagnostic tests
· Inform of therapy rendered, condition, and in-hospital progress of the patient, and condition of the patient at discharge.
9.3 The original medical records are the property of the Hospital and may not be removed from the Hospital, without a court order or subpoena, or as expressly approved by the Hospital CEO in writing. Copies of the medical records cannot be made without the permission of the Director of Medical Records. The medical records are maintained for the benefit of the patient, the Staff and the Hospital. The term medical record applies to any health information concerning a patient which is created, authenticated and retained in any format.
9.4 Access to and Confidentiality of Patient Records: No one, other than authorized Hospital personnel, shall have access to, or information from, the medical record except as described in the Hospital Medical Records Department policies and subject to the next paragraph of this Section 9.4. All requests for medical information shall be handled through the Medical Records Department.
Practitioners shall hold all individually identifiable patient health information (“Protected Health Information”) that may be shared, transferred, transmitted or otherwise obtained from or while at the Hospital strictly confidential, and shall provide all reasonable protection to prevent the unauthorized disclosure of such information, including, without limitation, the protection afforded by applicable federal, state and local laws and regulations regarding the security and the confidentiality of patient health information. For example only, Practitioners will comply with regulations, standards and rules promulgated pursuant to the authority of the Health Insurance Portability and Accountability Act of 1996 with HMC policies concerning Protected Health Information. Practitioners shall (a) maintain safeguards as necessary to ensure that the Protected Health
Information is not used or disclosed except as provided herein, (b) ensure that any subcontracts or agents to whom he provides Protected Health Information received from the Hospital will agree to the same restrictions and conditions that apply with respect to such information, (c) make available his respective internal practices, books and records relating to the use and disclosure of Protected Health Information received from the Hospital to the Department of Health and Human Services or its agents, (d) incorporate any amendments or corrections to Protected Health Information when notified by the Hospital that the information is accurate or incomplete, (e) return or destroy all Protected Health Information received from the Hospital that he still maintains in any form and not to retain ay such Protected Health Information in ay form upon termination of his Staff membership, (f) ensure applicable policies are in place for his providing access to Protected Health Information to
the subject of that information, (g) report to the Hospital’s Medical Director any use or disclosure of Protected Health Information which is not provided for in this Section 9.4.
9.5 Complete Medical Record: A complete medical record addresses the presence, timeliness, legibility and authentication of the following data and information as appropriate to the Hospital’s needs:
· Identification data;
· Medical history, including chief complaint, details of the present illness, relevant past, social, and family histories (appropriate to the patient’s age); and an inventory by body system;
· A summary of the patient’s psychosocial needs, as appropriate to the patient’s age;
· A report of relevant physical examination;
· A statement on the conclusions or impressions drawn from the admission history and physical examination;
· A statement on the course of action planned for the patient for this episode of care and of its periodic review, as appropriate;
· Diagnostic and therapeutic orders;
· Evidence of appropriate informed consent;
· Clinical observations, including the results of therapy;
· Progress notes made by the medical staff and other authorized staff;
· Consultation reports;
· Reports of operative and other invasive procedures, tests, and their results;
· Reports of any diagnostic and therapeutic procedures, such as pathology and clinical laboratory examinations and radiology and nuclear medicine
· Records of donation and receipt of transplants or implants;
· Final diagnosis(es);
· Conclusions at termination of hospitalization;
· Clinical resumes and discharge summaries;
· Discharge instructions to the patient or family; and
· When performed, results of autopsy.
9.6 Closing of Incomplete Medical Records Without Practitioner’s Signature: Every effort will be made to get all medical records completed prior to a practitioner’s departure from the Medical Staff. All records which remain incomplete after 90 days will be retired (a/k/a closed) upon written authorization of the Medical Director of Hillcrest Medical Center.
9.7 Verification: Every medical record entry shall be dated, its author identified and, when necessary, authenticated. Acceptable signatures may be provided in writing, initialing or by computer key. If computer key is used, a signed consent statement by the user that he is the sole user of the computer key must be on file. Stamped signatures are not accepted as authentication in the medical record.
9.8 Authentication: Entries of histories and physicals, operative procedures, consultation, discharge summaries and verbal or telephone orders, must be authenticated. Authentication occurs when the author reviews an entry and verifies that it is complete, accurate and final.
9.9 Operative Note: A handwritten operative note shall be made by the primary surgeon on the Hospital progress sheet immediately postoperatively that contains, at a minimum, name of primary surgeon and assistants, findings, technical procedures, specimens removed, postoperative diagnosis, and estimated loss of blood.
9.10 Progress Notes:
A. Admission progress notes will be on the chart within 24 hours of admission. The admission note will contain the chief complaint, provisional diagnosis and plan of treatment.
B. Progress notes will be completed daily by the attending physician or designee during the patient’s hospital stay. The progress notes should give a pertinent chronological report of the patient’s course in the Hospital. Progress notes must be dated and timed.
C. Progress notes by medical students need not be countersigned. If countersigned by the attending physician or chief resident, it is the official daily progress note, and it signifies approval.
9.11 History & Physical
A. The medical history and physical examination must be completed and documented by a physician, a resident or other licensed practitioner with history and physical privileges. Dentists and Podiatrists are responsible for their portion of the History and Physical. Third and fourth year medical students may not write or dictate histories and physicals.
B. A medical history and physical examination must be completed and documented for each patient no more than 30 days before or 24 hours after admission or registration, but prior to surgery or a procedure requiring anesthesia services.
C. An updated examination of the patient, including any changes in the patient’s condition must be completed and documented within 24 hours after admission or registration, but prior to surgery or a procedure requiring anesthesia services, when the medical history and physical examination are completed within 30 days before admission or registration. The updated examination of the patient, including any changes in the patient’s condition, must be completed and documented by a physician, a resident or other licensed practitioner with history and physical privileges. For patients leaving against medical advice within this 24-hour period, a brief final summary stating the reason for the admission and that the patient departed before the practitioner saw him should be recorded.
1) History and physical examination completed on a normal newborn is recorded on a check-off section of the infant record.
2) The short form history and physical is acceptable in its completed format on patients who are treated in the Same Day Surgery area, treated as an outpatient in other areas, who are admitted as an observation patient or for any stay less than 48 hours. For non-inpatient services, a H&P will
be required for any procedure requiring sedation or anesthesia. All patients admitted for an invasive procedure or a procedure requiring conscious sedation or anesthesia must have a H&P.
3) Except in cases of emergency, no patient shall be permitted to undergo surgery unless a history and physical examination has been completed and recorded on the chart.
4) The history includes the chief complaint, details of the present illness, including when appropriate, assessment of the patient’s emotional behavior and social status, relevant past, social and family histories appropriate to the patient’s age, and an inventory by body systems, plus the results of a relevant physical examination.
5) A durable, legible original or reproduction of the office or clinic prenatal record is acceptable as the history, as long as the last date seen was not over 30 days.
6) When a patient is readmitted within 30 days for the same or a related problem, an interval history and physical reflecting any subsequent changes may be used in the medical record, with a copy of the original information attached.
7) For series procedures, such as ECT, the H&P will be updated to reflect current status prior to each procedure.
D. Obstetrical records should include all prenatal information given in the following manner:
1) The prenatal record and the history and physical section of the labor record may be used in lieu of a dictated history and physical. The history and physical for OB patients must contain all the requirements of an H & P.
· A durable, legible original reproduction of the office or clinical prenatal record must be on the chart and signed by the physician, regardless of whether there is a dictated history and physical.
· Any prenatal record dated within 30 days of admission is acceptable, as long as it is updated to reflect patient’s status at the time of admission.
2) Surgery/anesthesia standards apply for elective C-section.
3. Vacuum and forcep assisted deliveries are considered operative procedures and require physicians to dictate or write an operative note.
9.12 Symbol and Abbreviation Policy: A policy of symbols and abbreviations (one meaning for each) will be approved by the Quality Improvement Council for use in the medical record. (Refer to Hospital Policy #5511).
9.13 Documentation to the Medical Record for Coding Queries: Physicians may authorize both licensed and non-licensed personnel under their supervision to answer written or verbal coding queries from the Health Information Management Department. The purpose to the queries will be documented in the medical record with the expectation that the entry will be co-signed by the Physician.
9.14 Suspension:
A. The medical record of each patient shall be completed within 30 days following date of discharge or date of service. Members will be notified by the Information Management Department of incomplete records at regular intervals. Those physicians responsible for delinquent records over 30 days shall have their admitting privileges automatically suspended. Physicians must complete all medical records before being removed from the suspension list. Procedures, which are to be performed in the Operating Suite, Cath Lab, GI Lab, and Radiology or out patient surgery, will not be scheduled for physicians whose admitting privileges have been suspended for delinquent medical records. A list of those physicians whose admitting privileges have been suspended shall be posted at all appropriate places in the Hospital, and the responsible staff physician shall be given written notice by the Medical Staff Services Department either by personal delivery or by certified mail. Suspension may be waived by the Medical Executive Committee if the Member’s physical incapacity prohibits completion of the records in a timely manner. (See Medical Staff Bylaws § 6.03-4)
B. If a physician fails to complete all available medical records within 30 additional days following the suspension of admitting privileges, in accordance with § 6.03-4 of the Bylaws he will be deemed to have resigned, and his Staff membership and clinical privileges will automatically terminate. The Medical Staff Services Department shall notify the physician in writing of his resignation and termination by personal delivery or by certified mail. When all available medical records are complete, the Member may thereafter apply to reappointment pursuant to the Procedure for Staff Appointment, except that he shall pay the initial application fee.
9.15 Ambulatory Care: The record of a patient treated in an ambulatory setting (i.e., same day surgery or outpatient cath) which includes but is not limited to 24 hour observation, will contain sufficient information to identify the patient, support the diagnosis, justify the treatment and document the course and results accurately.
9.16 Availability of Records from Previous Admissions: Previous medical records will be made available to the attending physician upon patient’s subsequent admission to the hospital.
X. MEDICATION
10.1 Formulary: The Formulary of the Hospital shall include drugs recommended by the Pharmacy and Therapeutic Committee. Generic or Trade names and the metric system will be standard. Request for additions to the Formulary must be presented and approved by the Pharmacy and Therapeutics Committee. (Refer to Hospital Policy #2011)
XI. ORDERS
11.1 Diagnostic and therapeutic orders shall include those written by Members, residents and allied health professionals, only if the orders are written within the scope of their clinical privileges or job descriptions.
11.2 Verbal Orders: All orders originally made verbally must be written in the medical record and dated. A responsible practitioner will sign the order. Verbal orders issued by allied health professionals within the scope of their job descriptions, shall be accepted and transcribed by Hospital employees. The following health care providers can accept and transcribe verbal orders for patients under their care, only within the scope of their professional practice: Registered Nurse, Licensed Practical Nurse, Registered respiratory therapist, certified rehabilitation therapist, registered pharmacist, registered dietitian, medical social worker, radiology technician, lab technician and allied health professional based upon job description.
11.3 All orders, including verbal orders, must be dated, timed and authenticated by the prescribing practitioner. Such orders must be authenticated with signature, date and time within 48 hours (CMS, 1-26-07). Authentication can be signed by another provider in the same group or call covering group. High-risk orders identified as Do Not
Resuscitate or NO Code Blue order will be signed within 24 hours. (Refer to Hospital Policy # 5502). Restraint orders will be dated, timed and signed according to the Restraint Policy and Procedure (Hospital Policy #2013).
11.4 Written orders for all medications must be complete and designate the drug, dosage, route, frequency and indication if PRN.
11.5 Standing orders (preprinted orders and protocols) may be formulated by individual members of the medical staff and must be on the approved form. All standing orders must be approved by appropriate Department and will be reviewed on an as needed basis. These orders shall be placed on the chart. Standing orders shall not replace or cancel those written for a specific patient.
11.6 Transfer Orders: When a patient’s care is assumed by a practitioner other than the admitting physician, an order for transfer of responsibility must be written by the transferring physician and acknowledged by the physician assuming the responsibility for the patient’s care.
11.7 Do Not Resuscitate: In circumstances involving discontinuance of life support systems, or in circumstances involving orders not to resuscitate, refer to the Hospital Policy #1019.
11.8 Medical Students: Orders written by third and fourth year medical students will not be carried out unless they are countersigned at the time they are written. If the orders are not carried out, the attending physician should mark through and initial the orders.
11.9 All orders will be discontinued in cases in which the patient is subject to general or regional anesthesia and shall have all orders rewritten by the appropriate physician. Renewal orders and postoperative orders must specify the name of the drugs or treatments to be received, and shall not be an order to resume previous orders.
11.10 Patient Restraints: Restraint or seclusion may be imposed only upon the time limited by written order of a physician. The order shall specify the duration and circumstances under which the restraint or seclusion is to be used or by the use of restraint guidelines approved by the Staff and available in the Hospital Policy # 2013.
11.11 Second Opinion: The primary responsibility for obtaining a second opinion is with the attending physician. If for any reason a hospitalized patient wishes to independently obtain a second opinion from another physician, the patient or his personal representative shall document, in writing, that he wishes to obtain a second opinion of another physician regarding his diagnosis, course of treatment or recommended procedure.
11.12 Physician Dismissal: If for any reason a patient wishes to release his physician and obtain the services of another physician, the patient shall document, in writing, that he wishes to release the attending physician from the responsibility of providing care. It is the responsibility of the patient to identify a physician who is willing to assume his care. In case of an emergency, when the patient or personal representative is unable to identify a new physician and the patient's health status is at risk, the appropriate Department Chief or the Medical Director will attempt to obtain a physician for the patient. Until a new physician has accepted the care of the patient, the original attending physician shall remain responsible for the patient.
XII. PEER REVIEW
Peer Review: All Members and allied health professionals will be subject to review of their activity in the Hospital as part of the ongoing process of performance improvement activities. Performance improvement activities will include, but not be limited to, measurement, aggregation and analysis of data, and improvement of performance on an organization wide basis. (Refer to Hospital Policy # 6501)
XIII. SURGERY
13.1 The patient’s chart must clearly indicate the preoperative diagnosis, the surgery contemplated and the reason for doing the surgery.
13.2 No patient shall be permitted to undergo surgery unless a history and physical examination, and appropriate laboratory work, have been completed and recorded on the chart, except in cases of emergency. On all inpatients an admission note stating the patient’s general physical status, preoperative diagnosis and contemplated surgery must be made prior to the operation. If the history and physical has been dictated but is not on the chart at the time of surgery, a temporary handwritten short form H & P may be utilized.
13.3 Instruments brought in from Outside: Instruments, devices and equipment may be brought in from outside the Hospital for use in the OR. Instrument sets that have been sterilized via steam from an outside source will be reprocessed according to the Hospital Sterilization policy. (See OR Policies)
Prosthesis provided by surgeons shall be identified as to type, brand, etc., when the procedure is scheduled. (See OR Policies)
13.4 Scheduling: A combination of surgeon block, specialty block and open scheduling is utilized in Hospital OR. The utilization of all blocks is reviewed monthly by the Operating Room Committee. (See OR Policy #B-5)
13.5 Visitors in the OR: There shall be no visitors allowed in the OR with the exception of residents or students enrolled in programs affiliated with HMC, who are involved with the care of the patient, sales representatives when rendering technical advice and with permission of the surgeon, and visiting physicians after proper notification by the Vice-President of Medical Affairs.
13.6 Laterality-OR/SDSC: Whenever any operation involves a question of laterality (i.e., right or left with no obvious lesion), the surgeon will confirm the correct side on which the surgery is to be performed in the operating room prior to prepping of the patient. (Refer to Hospital Policy #B.4.)
13.7 Surgical specimens: Surgical tissue shall be submitted to a Hospital pathologist, who shall examine the tissue and submit a written report. Surgical tissue shall be identified and its removal verified in the operative report. Types of tissue ordinarily not sent to pathology, unless requested by the attending physician, include:
· Cataracts
· Orthopedic appliances
· Foreign bodies
· Portions of rib removed to enhance operative exposure
· Therapeutic radioactive sources
· Teeth
XIV. THERAPEUTIC INTERRUPTION OF PREGNANCY
The therapeutic interruption of pregnancy shall be permissible at the Hospital for medical indications only. The policy (MS III-13) will not allow abortion on demand during any trimester. The policy will allow first and second trimester termination of pregnancy upon presentation of clear medical evidence of significant maternal risk or severe fetal damage.
XV. RESIDENTS IN PROFESSIONAL GRADUATE EDUCATION
PROGRAMS
15.1 Resident Supervision: Teaching faculty and attending physician Members who have responsibility for supervision of Residents at Hillcrest Medical Center must hold clinical privileges that reflect the scope of practice of Residents carrying out their patient care duties.
In order to assure appropriate supervision of Resident’s evaluating, treating and providing appropriate disposition of patients from the Emergency Department, the attending Member or senior resident, with an unrestricted license, has the responsibility to approve all treatment decisions as well as the disposition of the patient prior to the patient being discharged or admitted. All patient treatment options should be reviewed and approved by the senior resident prior to initiation. In all cases, treatment decisions by resident staff are the responsibility of the attending physician and, as such, must be authenticated by the attending Member.
15.2 Surgical Procedures: The teaching faculty physician must be present in the operating room and be able to see the operative field during all critical portions of the surgical procedure, and must be immediately available to furnish services during the rest of the surgical procedure if necessary.
To be “immediately available” means that the teaching faculty physician must be, or must arrange for another qualified physician to be (a) physically present in the Hospital, in close enough proximity to the OR or labor/delivery area to be able to return quickly if notified that there is a problem, and, except in the case of an emergency (b) not to be involved in another surgical procedure.
A teaching faculty physician may be involved in supervising not more than two overlapping procedures if he (a) is physically present in the OR or labor/delivery area during all critical portions of the first procedure before he commences supervision of a key portion of the second procedure, and (b) when he begins supervision of the second procedure, he must designate another qualified surgeon to be immediately available for the first procedure.
The teaching faculty physician must document the extent of his presence in each procedure, describe the critical portions and identify any other surgeon he designated to be immediately available.
15.3 Resident’s Scope of Practice: The scope of practice of a resident will be defined by the appropriate teaching program based upon the resident’s current training, expertise and experience. The recommended scope of practice for each level of residency training shall be submitted to the Hospital on an annual basis by the teaching programs for each resident in the program. In no case, will the scope or practice recommended exceed the type of privileges held by the supervising faculty or attending physicians.
15.4 Medical Record Responsibilities: Residents associated with the Hospital may complete various sections of the patient’s medical record, but portions of that documentation must be countersigned by the supervising attending physician. The supervising physician shall countersign the resident’s documentation:
· Discharge/death summary
· History and Physical
· Operative report
· Emergency report
15.5 Lines of Communication: The Hospital’s Professional Education Committee shall be the official committee to provide a mechanism for effective communication with the Medical Executive Committee and the Board of Trustees of the Hospital. This committee shall be composed of the program directors or selected faculty from each of the teaching programs. Senior residents from each program shall also be members of this committee. The Hospital administration and selected members of the Staff shall also serve on this committee.
15.6 Termination: Termination of a Resident working at the Hospital shall be handled in accordance with the appropriate teaching programs official policies.
XVI. ATTENDANCE REQUIREMENTS
All members of the Active and Provisional Active Staff are required to attend at least 50% of the Department meetings to which they are assigned. Attendance will be calculated and reviewed by the Department Chairman at reappointment time, and those physicians with insufficient attendance for the two year period will be fined $300. The fine must be paid prior to receiving their reappointment for the next two years.
724701.5
Revised: 06/19/09, 09/18/09, 10/23/09, 11/20/09
I. ADMISSION OF PATIENTS
1.1 Limitations: A Member with appropriate privileges may admit, consult and treat patients suffering from all types of diseases, except where adequate facilities and personnel are not available. The CEO or Medical Director of the Hospital may determine exceptions.
1.2 Admitting Privileges: Patients requiring admission may be admitted only by Members with admitting privileges. Up-to-date lists of the Staff are maintained by Medical Staff Services in the Star and Medical Staff Computer Systems.
1.3 Assignment of Patients to Physicians: Patients requiring admission through the Emergency Department who have no personal physician will be assigned to the “on-call” physician in a particular specialty based upon patient care need. The Emergency Department attending physician will make that determination regarding specialty need.
1.4 Provisional Diagnosis: No patient shall be admitted to the Hospital until a provisional diagnosis has been reported to the Registration Staff.
1.5 Psychiatric Admissions: Any Member with admitting privileges at the Hospital can admit to the Behavioral Services areas. The attending physician or the consulting psychiatrist must attend the scheduled weekly clinical staffing on the Adult Unit. All patients must have a psychiatric consultation within 24 hours of admission to inpatient Behavioral Services.
All patients transferred or admitted to Behavioral Services must be medically stable and have a primary psychiatric diagnosis stated in their medical records.
1.6 Physician Responsibility for Providing Information: Physicians admitting patients will be responsible for providing information for the protection of other patients and staff from those who are a source of danger or for protection of the patient from self-inflicted harm. Isolation or other special precautions will be ordered as appropriate and in accordance with the Hospital Infection Control and Isolation Manual.
1.7 Physician Transfer of Responsibility: The patient’s admitting physician is regarded as being in complete charge of the patient’s overall care until he orders transfer of that responsibility and it is accepted by another physician. Documentation of this transfer and acceptance of responsibility must be apparent in the physician’s orders or progress notes.
1.8 Attending Physician Responsibility: The attending physician, or such physician’s designee, will be required to personally visit a patient admitted to the Hospital within an appropriate time frame based upon the patient’s condition, never to exceed twelve (12) hours after order for admit is written or sooner as dictated by the patient’s medical condition; provided, however, for normal newborns and rehabilitation cases, or if the patient was seen by the admitting doctor within 12 hours before the admission and there is appropriate documentation and orders for the chart, the attending physician’s visit must occur within twenty-four (24) hours of admission. Thereafter, the attending physician, or other designated physician, including a consultant, will visit the patient every day during the remainder of the patient’s hospitalization. Patients admitted to the one of the critical care areas must be seen within two (2) hours of admission.
Summary: Initial admission assessment – 12 hours except:
normal newborns or rehabilitation – 24 hours
ICU – 2 hours
If patient seen by admitting doctor in the office within 12 hours
before
Daily visit by attending or designated physician
Consultations – within 24 hours after notification
1.9 Observation status requires that the patient meet criteria and a written order by the physician. Case Management or the Nursing Staff will contact the physician whose patient is approaching the 24-hour threshold in observation to determine the appropriate patient status and update information and orders. (Refer to Hospital Policy # 3002)
1.10 Transfer to or from the Kaiser Rehabilitation shall be considered a new admission. If the history and physical was dictated within 30 days, the physician shall write an addendum updating the patient’s condition. The acute hospital discharge summary will not suffice because it does not contain the required elements of a history and physical.
II. CONSENTS
2.1 The Hospital will secure a general hospital and medical consent from the patient or the patient’s legal representative or agent at the time of admission, or as soon as reasonably possible thereafter. Each patient’s medical record shall contain evidence of such general consent for treatment during hospitalization. The attending physician is responsible for obtaining informed consent for treatment.
2.2 Informed Consent: A written, signed, informed consent will be obtained prior to surgery or any other invasive procedure, except in emergencies and suitable signatures cannot be obtained due to the condition of the patient. In emergencies involving a minor or unconscious patient, in which consent for surgery cannot be obtained immediately from patients, personal representative or next of kin, those circumstances should be fully documented in the patient’s medical record. A consultation in such instances is advisable, if time permits, before the emergency surgery is undertaken. If more than one procedure is performed and another procedure is done by a different physician, then a separate consent must be obtained for each procedure. Surgeons are required to use language understandable to a patient when obtaining a consent for surgery. No abbreviations may be used in the consent. The practitioner shall document evidence on the informed consent of potential risk and benefits of the procedure(s) and any feasible alternative. A copy of the signed consent must be put in the patient’s medical record before surgery except in emergencies.
2.3 Organized Health Care Agreement: The Hospital and the Members of the Staff constitute an organized health care arrangement (OHCA) to allow the exchange of Protected Health Information for treatment, payment and healthcare operations of the OHCA. The terms “organized health care arrangement” and “Protected Health Information” shall have the meanings set forth in the Health Insurance Portability and Accountability Act (“HIPAA”). The OHCA participants provide services to mutual patients in a clinically integrated care setting and the sharing of such information benefits the common enterprise by allowing the participants to improve their joint operations and further quality patient care. The OCHA participants agree to abide by the terms of the joint Notice of Privacy Practices provided to patients of the Hospital. Each participant remains responsible for individual HIPAA compliance efforts. The OHCA does not mean that any participant is responsible for the violations of another participant.
III. CONSULTATIONS
3.1 If an attending physician determines that a consultation is necessary, he may request it. In any case of serious illness, in which the diagnosis is obscure, or when there is doubt as to the best therapeutic measures to be utilized, consultation should be sought by the attending physician. Request should be written and in addition the
consultant must be notified by direct physician to physician communication. The consultant physician may authorize other licensed personnel under their supervision may be notified. After discussion with the attending physician, the consultant may then order additional consultations.
3.2 The consultant shall have the obligation to see the patient in a timely fashion based upon the patient’s severity of illness, not to exceed 24 hours after notification. Consultants participating in active management of a case must visit the patient and document those visits in the patient’s medical record.
3.3 For surgical procedures, a consultative note will be recorded in the patient’s medical record prior to the operative procedure except in an emergency where unnecessary delay could threaten the life or well-being of the patient.
3.4 All patients admitted to a Critical Care area, except for those patients being actively managed by a Cardiologist or Surgeon, in his area of expertise, must be seen on a consultative basis by a critical care specialist. Consultation with the attending physician will follow. Consultation by the critical care specialist is required on all patients on a ventilator, except those post surgical patients awaiting routine post anesthesia extubation.
IV. DEATHS
4.1 Autopsies: Hospital encourages physicians to secure autopsies whenever appropriate. No autopsy shall be performed without written consent of the deceased’s personal representative, except for medical examiner cases. The policy of the Hospital is to perform post mortem examinations in deaths that meet criteria for autopsy. (Refer to Hospital Policy # 2018)
V. DISCHARGE
5.1 Patients will be discharged only on order of the attending physician or his designee. At the time of discharge, when possible, the attending physician or designee shall determine that the patient’s medical record is complete, state his final diagnosis, a complete list of all medications that the patient will be on upon discharge, and sign the record. Physicians should be aware of Rule 9.12, which requires that records of patients be completed within 30 days following discharge.
5.2 The discharge summary should concisely recapitulate the diagnosis and reason for hospitalization, the significant findings, the procedure performed and the treatment rendered, the condition of the patient on discharge, and all specific instructions given to the patient’s family or personal representative including medications that the patient will be on upon discharge.
5.3 The discharge summary shall be transcribed to insure legibility. Only the attending physician, resident and authorized allied health professional will be allowed to dictate discharge summaries.
5.4 A handwritten discharge summary may be used on stays less than 48 hours. Hospital form # 3806 should be used in these cases. All information in § 5.2 should be included.
5.5 The discharge diagnosis should be written on the progress notes or discharge instruction sheet.
5.6 A final progress note may be written in lieu of the discharge summary in cases of normal newborn infants and uncomplicated obstetrical deliveries, when the patient is hospitalized for less than 48 hours, with minor problems. The final note should include any instructions given to the patient and personal representatives.
5.7 All teaching cases must have a dictated/transcribed discharge summary with the exception of normal newborn and uncomplicated delivery charts and stays less than 48 hours. If dictated by a resident or authorized allied health professional, the discharge summary must be countersigned by the attending physician.
5.8 A death summary must be dictated on all death cases stating the reason for admission, the findings and course in the Hospital, and the events leading to the death.
VI. EMERGENCY COVERAGE/DEPARTMENT
6.1 A medical record will be kept on every patient who presents at the Emergency Department (“ED”). The emergency record will contain, as appropriate, patient identification, history of disease or injury, physical findings, laboratory and radiological reports, if any, diagnosis, determination of whether or not there was an emergency medical condition, record of treatment, disposition of the case, and signature of the physician rendering the service. A copy of the report of treatment will be made available to the patient’s primary care physician, if known.
6.2 The ED attending physician will make the decision regarding which surgical specialty physician to call for trauma patients with significant injuries.
6.3 All Active and Provisional Active Staff Members shall, and Courtesy Staff Members may be required to, provide on-call emergency department coverage for unassigned patients in their area of expertise. On-call physicians will be expected to respond by phone within 20 minutes and to be physically present, if warranted, within 30 minutes of the phone call or sooner if clinically indicated. The Chief of each Department will furnish to the Medical Staff Services Department a roster of physicians who are scheduled to provide emergency call on a monthly basis. If a specific specialty or subspecialty is not available for complete coverage for the ED call schedule, then the
Medical Staff Services Department will schedule ED coverage in those specialties and subspecialties to the extent feasible.
When the on-call physician cannot respond in a timely manner because of a situation beyond his control, or when a specific specialist or subspecialist is not available, the ED will, when appropriate, transfer the patient in accordance with the Hospital’s Emergency Screening, Stabilization and Transfer Policy. If an emergency exists, and the patient’s attending physician or his designated substitute physician is not available, the President of the Staff, the Medical Director or the Chief of the appropriate Department shall assign a qualified Member to assume the care of the patient until the patient’s physician is available.
6.4 If the ED is unable to reach the physician on call, the ED physician may at his discretion contact another Member with the appropriate privileges. The assigned physician shall be notified and shall determine management of the patient. The patient will be directed to the assigned physician for follow-up care. The ED physician determines management of the patient, unless admission or care beyond the usual level provided in the ED is needed.
VII. HOSPITAL POLICIES
All Hospital Policies and Procedures are available in the Medical Staff Services offices, and are available to all Members and allied health professionals. These Policies are also located on each Nursing Unit and within the Hospital Departments.
VIII. INSTITUTIONAL REVIEW BOARD
The Institutional Review Board (“IRB”) shall serve as the review body for all in-patient investigation drugs, devices and procedures. The IRB also reviews outpatient studies submitted for consideration. The primary purpose of the IRB is the protection of human subjects enrolled in research studies and clinical trials. The IRB makes periodic reports to the Clinical Quality, Professional Affairs, Medical Executive, and Board of Trustees committees.
IX. MEDICAL RECORDS
9.1 A medical record shall be maintained for every patient who is evaluated or treated at the Hospital as an inpatient, outpatient or
emergency patient, or who receives patient care services in any Hospital administered program.
9.2 All significant clinical information pertaining to the patient shall be incorporated in the patient’s medical record. The medical record shall contain sufficient information to:
· Identify the patient
· Reflect the diagnosis
· Give results of diagnostic tests
· Inform of therapy rendered, condition, and in-hospital progress of the patient, and condition of the patient at discharge.
9.3 The original medical records are the property of the Hospital and may not be removed from the Hospital, without a court order or subpoena, or as expressly approved by the Hospital CEO in writing. Copies of the medical records cannot be made without the permission of the Director of Medical Records. The medical records are maintained for the benefit of the patient, the Staff and the Hospital. The term medical record applies to any health information concerning a patient which is created, authenticated and retained in any format.
9.4 Access to and Confidentiality of Patient Records: No one, other than authorized Hospital personnel, shall have access to, or information from, the medical record except as described in the Hospital Medical Records Department policies and subject to the next paragraph of this Section 9.4. All requests for medical information shall be handled through the Medical Records Department.
Practitioners shall hold all individually identifiable patient health information (“Protected Health Information”) that may be shared, transferred, transmitted or otherwise obtained from or while at the Hospital strictly confidential, and shall provide all reasonable protection to prevent the unauthorized disclosure of such information, including, without limitation, the protection afforded by applicable federal, state and local laws and regulations regarding the security and the confidentiality of patient health information. For example only, Practitioners will comply with regulations, standards and rules promulgated pursuant to the authority of the Health Insurance Portability and Accountability Act of 1996 with HMC policies concerning Protected Health Information. Practitioners shall (a) maintain safeguards as necessary to ensure that the Protected Health
Information is not used or disclosed except as provided herein, (b) ensure that any subcontracts or agents to whom he provides Protected Health Information received from the Hospital will agree to the same restrictions and conditions that apply with respect to such information, (c) make available his respective internal practices, books and records relating to the use and disclosure of Protected Health Information received from the Hospital to the Department of Health and Human Services or its agents, (d) incorporate any amendments or corrections to Protected Health Information when notified by the Hospital that the information is accurate or incomplete, (e) return or destroy all Protected Health Information received from the Hospital that he still maintains in any form and not to retain ay such Protected Health Information in ay form upon termination of his Staff membership, (f) ensure applicable policies are in place for his providing access to Protected Health Information to
the subject of that information, (g) report to the Hospital’s Medical Director any use or disclosure of Protected Health Information which is not provided for in this Section 9.4.
9.5 Complete Medical Record: A complete medical record addresses the presence, timeliness, legibility and authentication of the following data and information as appropriate to the Hospital’s needs:
· Identification data;
· Medical history, including chief complaint, details of the present illness, relevant past, social, and family histories (appropriate to the patient’s age); and an inventory by body system;
· A summary of the patient’s psychosocial needs, as appropriate to the patient’s age;
· A report of relevant physical examination;
· A statement on the conclusions or impressions drawn from the admission history and physical examination;
· A statement on the course of action planned for the patient for this episode of care and of its periodic review, as appropriate;
· Diagnostic and therapeutic orders;
· Evidence of appropriate informed consent;
· Clinical observations, including the results of therapy;
· Progress notes made by the medical staff and other authorized staff;
· Consultation reports;
· Reports of operative and other invasive procedures, tests, and their results;
· Reports of any diagnostic and therapeutic procedures, such as pathology and clinical laboratory examinations and radiology and nuclear medicine
· Records of donation and receipt of transplants or implants;
· Final diagnosis(es);
· Conclusions at termination of hospitalization;
· Clinical resumes and discharge summaries;
· Discharge instructions to the patient or family; and
· When performed, results of autopsy.
9.6 Closing of Incomplete Medical Records Without Practitioner’s Signature: Every effort will be made to get all medical records completed prior to a practitioner’s departure from the Medical Staff. All records which remain incomplete after 90 days will be retired (a/k/a closed) upon written authorization of the Medical Director of Hillcrest Medical Center.
9.7 Verification: Every medical record entry shall be dated, its author identified and, when necessary, authenticated. Acceptable signatures may be provided in writing, initialing or by computer key. If computer key is used, a signed consent statement by the user that he is the sole user of the computer key must be on file. Stamped signatures are not accepted as authentication in the medical record.
9.8 Authentication: Entries of histories and physicals, operative procedures, consultation, discharge summaries and verbal or telephone orders, must be authenticated. Authentication occurs when the author reviews an entry and verifies that it is complete, accurate and final.
9.9 Operative Note: A handwritten operative note shall be made by the primary surgeon on the Hospital progress sheet immediately postoperatively that contains, at a minimum, name of primary surgeon and assistants, findings, technical procedures, specimens removed, postoperative diagnosis, and estimated loss of blood.
9.10 Progress Notes:
A. Admission progress notes will be on the chart within 24 hours of admission. The admission note will contain the chief complaint, provisional diagnosis and plan of treatment.
B. Progress notes will be completed daily by the attending physician or designee during the patient’s hospital stay. The progress notes should give a pertinent chronological report of the patient’s course in the Hospital. Progress notes must be dated and timed.
C. Progress notes by medical students need not be countersigned. If countersigned by the attending physician or chief resident, it is the official daily progress note, and it signifies approval.
9.11 History & Physical
A. The medical history and physical examination must be completed and documented by a physician, a resident or other licensed practitioner with history and physical privileges. Dentists and Podiatrists are responsible for their portion of the History and Physical. Third and fourth year medical students may not write or dictate histories and physicals.
B. A medical history and physical examination must be completed and documented for each patient no more than 30 days before or 24 hours after admission or registration, but prior to surgery or a procedure requiring anesthesia services.
C. An updated examination of the patient, including any changes in the patient’s condition must be completed and documented within 24 hours after admission or registration, but prior to surgery or a procedure requiring anesthesia services, when the medical history and physical examination are completed within 30 days before admission or registration. The updated examination of the patient, including any changes in the patient’s condition, must be completed and documented by a physician, a resident or other licensed practitioner with history and physical privileges. For patients leaving against medical advice within this 24-hour period, a brief final summary stating the reason for the admission and that the patient departed before the practitioner saw him should be recorded.
1) History and physical examination completed on a normal newborn is recorded on a check-off section of the infant record.
2) The short form history and physical is acceptable in its completed format on patients who are treated in the Same Day Surgery area, treated as an outpatient in other areas, who are admitted as an observation patient or for any stay less than 48 hours. For non-inpatient services, a H&P will
be required for any procedure requiring sedation or anesthesia. All patients admitted for an invasive procedure or a procedure requiring conscious sedation or anesthesia must have a H&P.
3) Except in cases of emergency, no patient shall be permitted to undergo surgery unless a history and physical examination has been completed and recorded on the chart.
4) The history includes the chief complaint, details of the present illness, including when appropriate, assessment of the patient’s emotional behavior and social status, relevant past, social and family histories appropriate to the patient’s age, and an inventory by body systems, plus the results of a relevant physical examination.
5) A durable, legible original or reproduction of the office or clinic prenatal record is acceptable as the history, as long as the last date seen was not over 30 days.
6) When a patient is readmitted within 30 days for the same or a related problem, an interval history and physical reflecting any subsequent changes may be used in the medical record, with a copy of the original information attached.
7) For series procedures, such as ECT, the H&P will be updated to reflect current status prior to each procedure.
D. Obstetrical records should include all prenatal information given in the following manner:
1) The prenatal record and the history and physical section of the labor record may be used in lieu of a dictated history and physical. The history and physical for OB patients must contain all the requirements of an H & P.
· A durable, legible original reproduction of the office or clinical prenatal record must be on the chart and signed by the physician, regardless of whether there is a dictated history and physical.
· Any prenatal record dated within 30 days of admission is acceptable, as long as it is updated to reflect patient’s status at the time of admission.
2) Surgery/anesthesia standards apply for elective C-section.
3. Vacuum and forcep assisted deliveries are considered operative procedures and require physicians to dictate or write an operative note.
9.12 Symbol and Abbreviation Policy: A policy of symbols and abbreviations (one meaning for each) will be approved by the Quality Improvement Council for use in the medical record. (Refer to Hospital Policy #5511).
9.13 Documentation to the Medical Record for Coding Queries: Physicians may authorize both licensed and non-licensed personnel under their supervision to answer written or verbal coding queries from the Health Information Management Department. The purpose to the queries will be documented in the medical record with the expectation that the entry will be co-signed by the Physician.
9.14 Suspension:
A. The medical record of each patient shall be completed within 30 days following date of discharge or date of service. Members will be notified by the Information Management Department of incomplete records at regular intervals. Those physicians responsible for delinquent records over 30 days shall have their admitting privileges automatically suspended. Physicians must complete all medical records before being removed from the suspension list. Procedures, which are to be performed in the Operating Suite, Cath Lab, GI Lab, and Radiology or out patient surgery, will not be scheduled for physicians whose admitting privileges have been suspended for delinquent medical records. A list of those physicians whose admitting privileges have been suspended shall be posted at all appropriate places in the Hospital, and the responsible staff physician shall be given written notice by the Medical Staff Services Department either by personal delivery or by certified mail. Suspension may be waived by the Medical Executive Committee if the Member’s physical incapacity prohibits completion of the records in a timely manner. (See Medical Staff Bylaws § 6.03-4)
B. If a physician fails to complete all available medical records within 30 additional days following the suspension of admitting privileges, in accordance with § 6.03-4 of the Bylaws he will be deemed to have resigned, and his Staff membership and clinical privileges will automatically terminate. The Medical Staff Services Department shall notify the physician in writing of his resignation and termination by personal delivery or by certified mail. When all available medical records are complete, the Member may thereafter apply to reappointment pursuant to the Procedure for Staff Appointment, except that he shall pay the initial application fee.
9.15 Ambulatory Care: The record of a patient treated in an ambulatory setting (i.e., same day surgery or outpatient cath) which includes but is not limited to 24 hour observation, will contain sufficient information to identify the patient, support the diagnosis, justify the treatment and document the course and results accurately.
9.16 Availability of Records from Previous Admissions: Previous medical records will be made available to the attending physician upon patient’s subsequent admission to the hospital.
X. MEDICATION
10.1 Formulary: The Formulary of the Hospital shall include drugs recommended by the Pharmacy and Therapeutic Committee. Generic or Trade names and the metric system will be standard. Request for additions to the Formulary must be presented and approved by the Pharmacy and Therapeutics Committee. (Refer to Hospital Policy #2011)
XI. ORDERS
11.1 Diagnostic and therapeutic orders shall include those written by Members, residents and allied health professionals, only if the orders are written within the scope of their clinical privileges or job descriptions.
11.2 Verbal Orders: All orders originally made verbally must be written in the medical record and dated. A responsible practitioner will sign the order. Verbal orders issued by allied health professionals within the scope of their job descriptions, shall be accepted and transcribed by Hospital employees. The following health care providers can accept and transcribe verbal orders for patients under their care, only within the scope of their professional practice: Registered Nurse, Licensed Practical Nurse, Registered respiratory therapist, certified rehabilitation therapist, registered pharmacist, registered dietitian, medical social worker, radiology technician, lab technician and allied health professional based upon job description.
11.3 All orders, including verbal orders, must be dated, timed and authenticated by the prescribing practitioner. Such orders must be authenticated with signature, date and time within 48 hours (CMS, 1-26-07). Authentication can be signed by another provider in the same group or call covering group. High-risk orders identified as Do Not
Resuscitate or NO Code Blue order will be signed within 24 hours. (Refer to Hospital Policy # 5502). Restraint orders will be dated, timed and signed according to the Restraint Policy and Procedure (Hospital Policy #2013).
11.4 Written orders for all medications must be complete and designate the drug, dosage, route, frequency and indication if PRN.
11.5 Standing orders (preprinted orders and protocols) may be formulated by individual members of the medical staff and must be on the approved form. All standing orders must be approved by appropriate Department and will be reviewed on an as needed basis. These orders shall be placed on the chart. Standing orders shall not replace or cancel those written for a specific patient.
11.6 Transfer Orders: When a patient’s care is assumed by a practitioner other than the admitting physician, an order for transfer of responsibility must be written by the transferring physician and acknowledged by the physician assuming the responsibility for the patient’s care.
11.7 Do Not Resuscitate: In circumstances involving discontinuance of life support systems, or in circumstances involving orders not to resuscitate, refer to the Hospital Policy #1019.
11.8 Medical Students: Orders written by third and fourth year medical students will not be carried out unless they are countersigned at the time they are written. If the orders are not carried out, the attending physician should mark through and initial the orders.
11.9 All orders will be discontinued in cases in which the patient is subject to general or regional anesthesia and shall have all orders rewritten by the appropriate physician. Renewal orders and postoperative orders must specify the name of the drugs or treatments to be received, and shall not be an order to resume previous orders.
11.10 Patient Restraints: Restraint or seclusion may be imposed only upon the time limited by written order of a physician. The order shall specify the duration and circumstances under which the restraint or seclusion is to be used or by the use of restraint guidelines approved by the Staff and available in the Hospital Policy # 2013.
11.11 Second Opinion: The primary responsibility for obtaining a second opinion is with the attending physician. If for any reason a hospitalized patient wishes to independently obtain a second opinion from another physician, the patient or his personal representative shall document, in writing, that he wishes to obtain a second opinion of another physician regarding his diagnosis, course of treatment or recommended procedure.
11.12 Physician Dismissal: If for any reason a patient wishes to release his physician and obtain the services of another physician, the patient shall document, in writing, that he wishes to release the attending physician from the responsibility of providing care. It is the responsibility of the patient to identify a physician who is willing to assume his care. In case of an emergency, when the patient or personal representative is unable to identify a new physician and the patient's health status is at risk, the appropriate Department Chief or the Medical Director will attempt to obtain a physician for the patient. Until a new physician has accepted the care of the patient, the original attending physician shall remain responsible for the patient.
XII. PEER REVIEW
Peer Review: All Members and allied health professionals will be subject to review of their activity in the Hospital as part of the ongoing process of performance improvement activities. Performance improvement activities will include, but not be limited to, measurement, aggregation and analysis of data, and improvement of performance on an organization wide basis. (Refer to Hospital Policy # 6501)
XIII. SURGERY
13.1 The patient’s chart must clearly indicate the preoperative diagnosis, the surgery contemplated and the reason for doing the surgery.
13.2 No patient shall be permitted to undergo surgery unless a history and physical examination, and appropriate laboratory work, have been completed and recorded on the chart, except in cases of emergency. On all inpatients an admission note stating the patient’s general physical status, preoperative diagnosis and contemplated surgery must be made prior to the operation. If the history and physical has been dictated but is not on the chart at the time of surgery, a temporary handwritten short form H & P may be utilized.
13.3 Instruments brought in from Outside: Instruments, devices and equipment may be brought in from outside the Hospital for use in the OR. Instrument sets that have been sterilized via steam from an outside source will be reprocessed according to the Hospital Sterilization policy. (See OR Policies)
Prosthesis provided by surgeons shall be identified as to type, brand, etc., when the procedure is scheduled. (See OR Policies)
13.4 Scheduling: A combination of surgeon block, specialty block and open scheduling is utilized in Hospital OR. The utilization of all blocks is reviewed monthly by the Operating Room Committee. (See OR Policy #B-5)
13.5 Visitors in the OR: There shall be no visitors allowed in the OR with the exception of residents or students enrolled in programs affiliated with HMC, who are involved with the care of the patient, sales representatives when rendering technical advice and with permission of the surgeon, and visiting physicians after proper notification by the Vice-President of Medical Affairs.
13.6 Laterality-OR/SDSC: Whenever any operation involves a question of laterality (i.e., right or left with no obvious lesion), the surgeon will confirm the correct side on which the surgery is to be performed in the operating room prior to prepping of the patient. (Refer to Hospital Policy #B.4.)
13.7 Surgical specimens: Surgical tissue shall be submitted to a Hospital pathologist, who shall examine the tissue and submit a written report. Surgical tissue shall be identified and its removal verified in the operative report. Types of tissue ordinarily not sent to pathology, unless requested by the attending physician, include:
· Cataracts
· Orthopedic appliances
· Foreign bodies
· Portions of rib removed to enhance operative exposure
· Therapeutic radioactive sources
· Teeth
XIV. THERAPEUTIC INTERRUPTION OF PREGNANCY
The therapeutic interruption of pregnancy shall be permissible at the Hospital for medical indications only. The policy (MS III-13) will not allow abortion on demand during any trimester. The policy will allow first and second trimester termination of pregnancy upon presentation of clear medical evidence of significant maternal risk or severe fetal damage.
XV. RESIDENTS IN PROFESSIONAL GRADUATE EDUCATION
PROGRAMS
15.1 Resident Supervision: Teaching faculty and attending physician Members who have responsibility for supervision of Residents at Hillcrest Medical Center must hold clinical privileges that reflect the scope of practice of Residents carrying out their patient care duties.
In order to assure appropriate supervision of Resident’s evaluating, treating and providing appropriate disposition of patients from the Emergency Department, the attending Member or senior resident, with an unrestricted license, has the responsibility to approve all treatment decisions as well as the disposition of the patient prior to the patient being discharged or admitted. All patient treatment options should be reviewed and approved by the senior resident prior to initiation. In all cases, treatment decisions by resident staff are the responsibility of the attending physician and, as such, must be authenticated by the attending Member.
15.2 Surgical Procedures: The teaching faculty physician must be present in the operating room and be able to see the operative field during all critical portions of the surgical procedure, and must be immediately available to furnish services during the rest of the surgical procedure if necessary.
To be “immediately available” means that the teaching faculty physician must be, or must arrange for another qualified physician to be (a) physically present in the Hospital, in close enough proximity to the OR or labor/delivery area to be able to return quickly if notified that there is a problem, and, except in the case of an emergency (b) not to be involved in another surgical procedure.
A teaching faculty physician may be involved in supervising not more than two overlapping procedures if he (a) is physically present in the OR or labor/delivery area during all critical portions of the first procedure before he commences supervision of a key portion of the second procedure, and (b) when he begins supervision of the second procedure, he must designate another qualified surgeon to be immediately available for the first procedure.
The teaching faculty physician must document the extent of his presence in each procedure, describe the critical portions and identify any other surgeon he designated to be immediately available.
15.3 Resident’s Scope of Practice: The scope of practice of a resident will be defined by the appropriate teaching program based upon the resident’s current training, expertise and experience. The recommended scope of practice for each level of residency training shall be submitted to the Hospital on an annual basis by the teaching programs for each resident in the program. In no case, will the scope or practice recommended exceed the type of privileges held by the supervising faculty or attending physicians.
15.4 Medical Record Responsibilities: Residents associated with the Hospital may complete various sections of the patient’s medical record, but portions of that documentation must be countersigned by the supervising attending physician. The supervising physician shall countersign the resident’s documentation:
· Discharge/death summary
· History and Physical
· Operative report
· Emergency report
15.5 Lines of Communication: The Hospital’s Professional Education Committee shall be the official committee to provide a mechanism for effective communication with the Medical Executive Committee and the Board of Trustees of the Hospital. This committee shall be composed of the program directors or selected faculty from each of the teaching programs. Senior residents from each program shall also be members of this committee. The Hospital administration and selected members of the Staff shall also serve on this committee.
15.6 Termination: Termination of a Resident working at the Hospital shall be handled in accordance with the appropriate teaching programs official policies.
XVI. ATTENDANCE REQUIREMENTS
All members of the Active and Provisional Active Staff are required to attend at least 50% of the Department meetings to which they are assigned. Attendance will be calculated and reviewed by the Department Chairman at reappointment time, and those physicians with insufficient attendance for the two year period will be fined $300. The fine must be paid prior to receiving their reappointment for the next two years.
724701.5
Revised: 06/19/09, 09/18/09, 10/23/09, 11/20/09
Thursday, January 7, 2010
Meaningful Use
CMS and ONC Issue Regulations Proposing a Definition of ‘Meaningful Use’ and Setting Standards for Electronic Health Record Incentive Program
Public Encouraged to Comment on New Regulations
The Centers for Medicare & Medicare Services (CMS) and the Office of the National Coordinator for Health Information Technology (ONC) encourage public comment on two regulations issued today that lay a foundation for improving quality, efficiency and safety through meaningful use of certified electronic health record (EHR) technology. The regulations will help implement the EHR incentive programs enacted under the American Recovery and Reinvestment Act of 2009 (Recovery Act).
A proposed rule issued by CMS outlines proposed provisions governing the EHR incentive programs, including defining the central concept of “meaningful use” of EHR technology. An interim final regulation (IFR) issued by ONC sets initial standards, implementation specifications, and certification criteria for EHR technology. Both regulations are open to public comment.
“Widespread adoption of electronic health records holds great promise for improving health care quality, efficiency, and patient safety,” said, National Coordinator for Health Information Technology David Blumenthal, M.D., M.P.P. “The Recovery Act’s financial incentives demonstrate Congress’ and the Administration’s commitment to help providers adopt and make meaningful use of EHR technology so they can give better care and their patients’ experience of care will improve. Over time, we believe the EHR incentive program under Medicare and Medicaid will accelerate and facilitate health information technology adoption by more individual providers and organizations throughout the health care system.”
“These regulations are closely linked,” said Charlene Frizzera, CMS acting administrator. “CMS’s proposed regulation would define and specify how to demonstrate ‘meaningful use’ of EHR technology, which is a prerequisite for receiving the Medicare incentive payments. Our rule also outlines the proposed payment methodologies for the Medicare and Medicaid EHR incentive programs. ONC’s regulation sets forth the standards and specifications that will enhance the interoperability, functionality, utility and security of health information technology.”
CMS and ONC worked closely to develop the two rules and received input from hundreds of technical subject matters experts, health care providers, and other key stakeholders. Numerous public meetings to solicit public comment were held by three Federal advisory committees: the National Committee on Vital and Health Statistics (NCVHS), the Health IT Policy Committee (HITPC), and the Health IT Standards Committee (HITSC). HITSC presented its final recommendations to the National Coordinator in August 2009. These recommendations, along with all other input were considered to help inform the development of the regulations announced today.
The IFR issued by ONC describes the standards that must be met by certified EHR technology to exchange healthcare information among providers and between providers and patients. This initial set of standards begins to define a common language to ensure accurate and secure health information exchange across different EHR systems. The IFR describes standard formats for clinical summaries and prescriptions; standard terms to describe clinical problems, procedures, laboratory tests, medications and allergies; and standards for the secure transportation of this information using the Internet.
The IFR calls for the industry to standardize the way in which EHR information is exchanged between organizations, and sets forth criteria required for an EHR technology to be certified. These standards will support meaningful use and data exchange among providers who must use certified EHR technology to qualify for the Medicare and Medicaid incentives.
Under the statute, HHS is required to adopt an initial set of standards for EHR technology by Dec. 31, 2009. The IFR will go into effect 30 days after publication, with an opportunity for public comment and refinement over the next 60 days. A final rule will be issued in 2010. “We strongly encourage stakeholders to provide comments on these standards and specifications,” Dr. Blumenthal said.
The Recovery Act established programs to provide incentive payments to eligible professionals and eligible hospitals participating in Medicare and Medicaid that adopt and make “meaningful use” of certified EHR technology. Incentive payments may begin as soon as October 2010 to eligible hospitals. Incentive payments to other eligible providers may begin in January 2011.
The proposed rule would define the term "meaningful EHR user" as an eligible professional or eligible hospital that, during the specified reporting period, demonstrates meaningful use of certified EHR technology in a form and manner consistent with certain objectives and measures presented in the regulation. These objectives and measures would include use of certified EHR technology in a manner that improves quality, safety, and efficiency of health care delivery, reduces health care disparities, engages patients and families, improves care coordination, improves population and public health, and ensures adequate privacy and security protections for personal health information.
The proposed rule would define meaningful use for the Medicare EHR incentive programs. It proposes one definition that would apply to eligible professionals participating in the Medicare fee-for-service and the Medicare Advantage EHR incentive programs as well as a proposed definition that would apply to eligible hospitals and critical access hospitals. These definitions also would serve as the minimum standard for eligible professionals and eligible hospitals participating in the Medicaid EHR incentive program. The rule proposes that states could request CMS approval to implement additional meaningful use measures, as appropriate, but could not request approval of fewer or less rigorous meaningful use measures than required by the rule.
This rule proposes a phased approach to implement the proposed requirements for demonstrating meaningful use. This approach would initially establish reasonable criteria for meaningful use based on currently available technological capabilities and providers’ practice experience. CMS will establish stricter and more extensive criteria for demonstrating meaningful use over time, as anticipated developments in technology and providers’ capabilities occur.
CMS provides a 60-day comment period on the proposed rule. “The definition and requirements for demonstrating meaningful use of EHR technology are proposals. CMS welcomes and will give serious consideration to comments that improve our proposal while achieving the goals Congress established for the EHR incentive programs,” Frizzera said.
The CMS proposed rule and fact sheets, may be viewed at http://www.cms.hhs.gov/Recovery/11_HealthIT.asp
ONC’s interim final rule may be viewed at http://healthit.hhs.gov/standardsandcertification. In early 2010 ONC intends to issue a notice of proposed rulemaking related to the certification of health information technology.
Public Encouraged to Comment on New Regulations
The Centers for Medicare & Medicare Services (CMS) and the Office of the National Coordinator for Health Information Technology (ONC) encourage public comment on two regulations issued today that lay a foundation for improving quality, efficiency and safety through meaningful use of certified electronic health record (EHR) technology. The regulations will help implement the EHR incentive programs enacted under the American Recovery and Reinvestment Act of 2009 (Recovery Act).
A proposed rule issued by CMS outlines proposed provisions governing the EHR incentive programs, including defining the central concept of “meaningful use” of EHR technology. An interim final regulation (IFR) issued by ONC sets initial standards, implementation specifications, and certification criteria for EHR technology. Both regulations are open to public comment.
“Widespread adoption of electronic health records holds great promise for improving health care quality, efficiency, and patient safety,” said, National Coordinator for Health Information Technology David Blumenthal, M.D., M.P.P. “The Recovery Act’s financial incentives demonstrate Congress’ and the Administration’s commitment to help providers adopt and make meaningful use of EHR technology so they can give better care and their patients’ experience of care will improve. Over time, we believe the EHR incentive program under Medicare and Medicaid will accelerate and facilitate health information technology adoption by more individual providers and organizations throughout the health care system.”
“These regulations are closely linked,” said Charlene Frizzera, CMS acting administrator. “CMS’s proposed regulation would define and specify how to demonstrate ‘meaningful use’ of EHR technology, which is a prerequisite for receiving the Medicare incentive payments. Our rule also outlines the proposed payment methodologies for the Medicare and Medicaid EHR incentive programs. ONC’s regulation sets forth the standards and specifications that will enhance the interoperability, functionality, utility and security of health information technology.”
CMS and ONC worked closely to develop the two rules and received input from hundreds of technical subject matters experts, health care providers, and other key stakeholders. Numerous public meetings to solicit public comment were held by three Federal advisory committees: the National Committee on Vital and Health Statistics (NCVHS), the Health IT Policy Committee (HITPC), and the Health IT Standards Committee (HITSC). HITSC presented its final recommendations to the National Coordinator in August 2009. These recommendations, along with all other input were considered to help inform the development of the regulations announced today.
The IFR issued by ONC describes the standards that must be met by certified EHR technology to exchange healthcare information among providers and between providers and patients. This initial set of standards begins to define a common language to ensure accurate and secure health information exchange across different EHR systems. The IFR describes standard formats for clinical summaries and prescriptions; standard terms to describe clinical problems, procedures, laboratory tests, medications and allergies; and standards for the secure transportation of this information using the Internet.
The IFR calls for the industry to standardize the way in which EHR information is exchanged between organizations, and sets forth criteria required for an EHR technology to be certified. These standards will support meaningful use and data exchange among providers who must use certified EHR technology to qualify for the Medicare and Medicaid incentives.
Under the statute, HHS is required to adopt an initial set of standards for EHR technology by Dec. 31, 2009. The IFR will go into effect 30 days after publication, with an opportunity for public comment and refinement over the next 60 days. A final rule will be issued in 2010. “We strongly encourage stakeholders to provide comments on these standards and specifications,” Dr. Blumenthal said.
The Recovery Act established programs to provide incentive payments to eligible professionals and eligible hospitals participating in Medicare and Medicaid that adopt and make “meaningful use” of certified EHR technology. Incentive payments may begin as soon as October 2010 to eligible hospitals. Incentive payments to other eligible providers may begin in January 2011.
The proposed rule would define the term "meaningful EHR user" as an eligible professional or eligible hospital that, during the specified reporting period, demonstrates meaningful use of certified EHR technology in a form and manner consistent with certain objectives and measures presented in the regulation. These objectives and measures would include use of certified EHR technology in a manner that improves quality, safety, and efficiency of health care delivery, reduces health care disparities, engages patients and families, improves care coordination, improves population and public health, and ensures adequate privacy and security protections for personal health information.
The proposed rule would define meaningful use for the Medicare EHR incentive programs. It proposes one definition that would apply to eligible professionals participating in the Medicare fee-for-service and the Medicare Advantage EHR incentive programs as well as a proposed definition that would apply to eligible hospitals and critical access hospitals. These definitions also would serve as the minimum standard for eligible professionals and eligible hospitals participating in the Medicaid EHR incentive program. The rule proposes that states could request CMS approval to implement additional meaningful use measures, as appropriate, but could not request approval of fewer or less rigorous meaningful use measures than required by the rule.
This rule proposes a phased approach to implement the proposed requirements for demonstrating meaningful use. This approach would initially establish reasonable criteria for meaningful use based on currently available technological capabilities and providers’ practice experience. CMS will establish stricter and more extensive criteria for demonstrating meaningful use over time, as anticipated developments in technology and providers’ capabilities occur.
CMS provides a 60-day comment period on the proposed rule. “The definition and requirements for demonstrating meaningful use of EHR technology are proposals. CMS welcomes and will give serious consideration to comments that improve our proposal while achieving the goals Congress established for the EHR incentive programs,” Frizzera said.
The CMS proposed rule and fact sheets, may be viewed at http://www.cms.hhs.gov/Recovery/11_HealthIT.asp
ONC’s interim final rule may be viewed at http://healthit.hhs.gov/standardsandcertification. In early 2010 ONC intends to issue a notice of proposed rulemaking related to the certification of health information technology.
Saturday, January 2, 2010
New ADA DM stuff
December 29, 2009 — The American Diabetes Association (ADA) revised clinical practice recommendations for diabetes diagnosis promote hemoglobin A1c (A1c) as a faster, easier diagnostic test that could help reduce the number of undiagnosed patients and better identify patients with prediabetes. The new recommendations are published December 29 in the January supplement of Diabetes Care.
"We believe that use of the A1c, because it doesn't require fasting, will encourage more people to get tested for type 2 diabetes and help further reduce the number of people who are undiagnosed but living with this chronic and potentially life-threatening disease," Richard M. Bergenstal, MD, ADA president-elect of medicine & science, said in a news release. "Additionally, early detection can make an enormous difference in a person's quality of life. Unlike many chronic diseases, type 2 diabetes actually can be prevented, as long as lifestyle changes are made while blood glucose levels are still in the pre-diabetes range."
The A1c test, which measures average blood glucose levels for a period of up to 3 months, was previously used only to evaluate diabetic control with time. An A1c level of approximately 5% indicates the absence of diabetes, and according to the revised evidence-based guidelines, an A1c score of 5.7% to 6.4% indicates prediabetes, and an A1c level of 6.5% or higher indicates the presence of diabetes.
For optimal diabetic control, the recommended ADA target for most people with diabetes is an A1c level no greater than 7%. It is hoped that achieving this target would help prevent serious diabetes-related complications including nephropathy, neuropathy, retinopathy, and gum disease.
Unlike fasting plasma glucose testing and the oral glucose tolerance test, A1c testing does not require overnight fasting. Compliance with screening may therefore be improved through use of the A1c test, which can be determined from a single nonfasting blood sample.
Recommendation Changes for 2010
Specific changes in the 2010 Clinical Practice Recommendations are as follows:
* A section on diabetes related to cystic fibrosis has been added to "Standards of Medical Care in Diabetes." New evidence has shown that early diagnosis of cystic fibrosis-related diabetes and aggressive treatment with insulin have narrowed the gap in mortality between patients with cystic fibrosis with and without diabetes and have eliminated the sex difference in mortality rates. New recommendations for the clinical management of cystic fibrosis-related diabetes, based on a 2009 consensus conference, will be published in 2010 in a consensus report.
* Revision of the section "Diagnosis of Diabetes" now includes the use of the A1c level for diabetes diagnosis, with a cutoff point of 6.5%.
* The section formerly named "Diagnosis of Pre-diabetes" is now named "Categories of Increased Risk for Diabetes." Categories suggesting an increased risk for future diabetes now include an A1c range of 5.7% to 6.4%, as well as impaired fasting glucose and impaired glucose tolerance levels.
* Revisions to the section "Detection and Diagnosis of GDM [Gestational Diabetes Mellitus]" now include a discussion of possible future changes in this diagnosis, according to international consensus. Screening recommendations for gestational diabetes are to use risk factor analysis and an oral glucose tolerance test, if appropriate. Women diagnosed with gestational diabetes should be screened for diabetes 6 to 12 weeks postpartum and should have subsequent screening for the development of diabetes or prediabetes.
* Extensive revisions to the section "Diabetes Self-Management Education" are based on new evidence. Goals of diabetes self-management education are to improve adherence to standard of care, to educate patients regarding appropriate glycemic targets, and to increase the percentage of patients achieving target A1c levels.
* Extensive revisions to the section "Antiplatelet Agents" now reflect evidence from recent trials suggesting that in moderate- or low-risk patients, aspirin is of questionable benefit for primary prevention of cardiovascular disease. The revised recommendation is to consider aspirin treatment as a primary prevention strategy in patients with diabetes who are at increased cardiovascular risk, defined as a 10-year risk greater than 10%. Patients at increased cardiovascular risk include men older than 50 years or women older than 60 years with at least 1 additional major risk factor.
* Fundus photography may be used as a screening strategy for retinopathy, as described in the section "Retinopathy Screening and Treatment." However, although high-quality fundus photographs detect most clinically significant diabetic retinopathy, they should not act as a substitute for an initial and dilated comprehensive eye examination. Retinal examinations should be carried out annually or at least every 2 to 3 years among low-risk patients with normal eye examination results in the past.
* Extensive revisions to the section "Diabetes Care in the Hospital" now question the benefit of very tight glycemic control goals in critically ill patients, based on new evidence.
* Extensive revisions to the section "Strategies for Improving Diabetes Care" are based on newer evidence. Successful strategies to improve diabetes care, which have resulted in improved process measures such as measurement of A1c levels, lipid levels, and blood pressure, include the following:
o Delivery of diabetes self-management education.
o Adoption of practice guidelines developed with participation of healthcare professionals and having them readily accessible at the point of service.
o Use of checklists mirroring guidelines, which help improve adherence to standards of care.
o Systems changes, including providing automated reminders to healthcare professionals and patients and audit and feedback of process and outcome data to providers.
o Quality improvement programs, in which continuous quality improvement or other cycles of analysis and intervention are combined with provider performance data.
o Practice changes, which may include access to point-of-care A1c testing, scheduling planned diabetes visits, and clustering dedicated diabetes visits into specific times.
o Tracking systems with either an electronic medical record or patient registry to improve adherence to standards of care.
o Availability of case or (preferably) care management services using nurses, pharmacists, and other nonphysician healthcare professionals following detailed algorithms under physician supervision.
"The most successful practices have an institutional priority for quality of care, involve all of the staff in their initiatives, redesign their delivery system, activate and educate their patients, and use electronic health record tools," the guidelines authors conclude. "It is clear that optimal diabetes management requires an organized, systematic approach and involvement of a coordinated team of dedicated health care professionals working in an environment where quality care is a priority."
"We believe that use of the A1c, because it doesn't require fasting, will encourage more people to get tested for type 2 diabetes and help further reduce the number of people who are undiagnosed but living with this chronic and potentially life-threatening disease," Richard M. Bergenstal, MD, ADA president-elect of medicine & science, said in a news release. "Additionally, early detection can make an enormous difference in a person's quality of life. Unlike many chronic diseases, type 2 diabetes actually can be prevented, as long as lifestyle changes are made while blood glucose levels are still in the pre-diabetes range."
The A1c test, which measures average blood glucose levels for a period of up to 3 months, was previously used only to evaluate diabetic control with time. An A1c level of approximately 5% indicates the absence of diabetes, and according to the revised evidence-based guidelines, an A1c score of 5.7% to 6.4% indicates prediabetes, and an A1c level of 6.5% or higher indicates the presence of diabetes.
For optimal diabetic control, the recommended ADA target for most people with diabetes is an A1c level no greater than 7%. It is hoped that achieving this target would help prevent serious diabetes-related complications including nephropathy, neuropathy, retinopathy, and gum disease.
Unlike fasting plasma glucose testing and the oral glucose tolerance test, A1c testing does not require overnight fasting. Compliance with screening may therefore be improved through use of the A1c test, which can be determined from a single nonfasting blood sample.
Recommendation Changes for 2010
Specific changes in the 2010 Clinical Practice Recommendations are as follows:
* A section on diabetes related to cystic fibrosis has been added to "Standards of Medical Care in Diabetes." New evidence has shown that early diagnosis of cystic fibrosis-related diabetes and aggressive treatment with insulin have narrowed the gap in mortality between patients with cystic fibrosis with and without diabetes and have eliminated the sex difference in mortality rates. New recommendations for the clinical management of cystic fibrosis-related diabetes, based on a 2009 consensus conference, will be published in 2010 in a consensus report.
* Revision of the section "Diagnosis of Diabetes" now includes the use of the A1c level for diabetes diagnosis, with a cutoff point of 6.5%.
* The section formerly named "Diagnosis of Pre-diabetes" is now named "Categories of Increased Risk for Diabetes." Categories suggesting an increased risk for future diabetes now include an A1c range of 5.7% to 6.4%, as well as impaired fasting glucose and impaired glucose tolerance levels.
* Revisions to the section "Detection and Diagnosis of GDM [Gestational Diabetes Mellitus]" now include a discussion of possible future changes in this diagnosis, according to international consensus. Screening recommendations for gestational diabetes are to use risk factor analysis and an oral glucose tolerance test, if appropriate. Women diagnosed with gestational diabetes should be screened for diabetes 6 to 12 weeks postpartum and should have subsequent screening for the development of diabetes or prediabetes.
* Extensive revisions to the section "Diabetes Self-Management Education" are based on new evidence. Goals of diabetes self-management education are to improve adherence to standard of care, to educate patients regarding appropriate glycemic targets, and to increase the percentage of patients achieving target A1c levels.
* Extensive revisions to the section "Antiplatelet Agents" now reflect evidence from recent trials suggesting that in moderate- or low-risk patients, aspirin is of questionable benefit for primary prevention of cardiovascular disease. The revised recommendation is to consider aspirin treatment as a primary prevention strategy in patients with diabetes who are at increased cardiovascular risk, defined as a 10-year risk greater than 10%. Patients at increased cardiovascular risk include men older than 50 years or women older than 60 years with at least 1 additional major risk factor.
* Fundus photography may be used as a screening strategy for retinopathy, as described in the section "Retinopathy Screening and Treatment." However, although high-quality fundus photographs detect most clinically significant diabetic retinopathy, they should not act as a substitute for an initial and dilated comprehensive eye examination. Retinal examinations should be carried out annually or at least every 2 to 3 years among low-risk patients with normal eye examination results in the past.
* Extensive revisions to the section "Diabetes Care in the Hospital" now question the benefit of very tight glycemic control goals in critically ill patients, based on new evidence.
* Extensive revisions to the section "Strategies for Improving Diabetes Care" are based on newer evidence. Successful strategies to improve diabetes care, which have resulted in improved process measures such as measurement of A1c levels, lipid levels, and blood pressure, include the following:
o Delivery of diabetes self-management education.
o Adoption of practice guidelines developed with participation of healthcare professionals and having them readily accessible at the point of service.
o Use of checklists mirroring guidelines, which help improve adherence to standards of care.
o Systems changes, including providing automated reminders to healthcare professionals and patients and audit and feedback of process and outcome data to providers.
o Quality improvement programs, in which continuous quality improvement or other cycles of analysis and intervention are combined with provider performance data.
o Practice changes, which may include access to point-of-care A1c testing, scheduling planned diabetes visits, and clustering dedicated diabetes visits into specific times.
o Tracking systems with either an electronic medical record or patient registry to improve adherence to standards of care.
o Availability of case or (preferably) care management services using nurses, pharmacists, and other nonphysician healthcare professionals following detailed algorithms under physician supervision.
"The most successful practices have an institutional priority for quality of care, involve all of the staff in their initiatives, redesign their delivery system, activate and educate their patients, and use electronic health record tools," the guidelines authors conclude. "It is clear that optimal diabetes management requires an organized, systematic approach and involvement of a coordinated team of dedicated health care professionals working in an environment where quality care is a priority."
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