Process of Care paper: Performance of Hospitals

Process of Care Paper

1) Access the Hospital Compare website (https://www(dot)medicare(dot)gov/hospitalcompare/search.html) and select a local hospital. Look at the hospital's publically reported indicators for Process of Care.
2) Write a paper of 1,000-1,200 words that analyzes how the selected hospital performs on these indicators versus two of its competitors. Include your thoughts on the pros and cons of publically reporting these data sets.
3) Refer to the website and incorporate specific examples and details into your paper.
4) Prepare this assignment according to the APA guidelines found in the APA Style Guide, located in the Student Success Center. An abstract is not required.
5) This assignment uses a grading rubric. Instructors will be using the rubric to grade the assignment; therefore, students should review the rubric prior to beginning the assignment to become familiar with the assignment criteria and expectations for successful completion of the assignment.
You are required to submit this assignment to LopesWrite. Please refer to the directions in the Student Success Center.
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Process of Care Paper - Rubric
No of Criteria: 7 Achievement Levels: 5
Criteria
Achievement Levels
Description Percentage
Unsatisfactory
0.00 %
Less Than Satisfactory
65.00 %
Satisfactory
75.00 %
Good
85.00 %
Excellent
100.00 %
Content
70.0

Access the Hospital Compare Web site (www(dot)Hospitalcompare(dot)hhs(dot)gov) and select a local hospital. Look at the hospitals publically reported indicators for Process of Care. Write a paper that analyzes how the hospital performs on these indicators versus two of its competitors. Include your thoughts on the pros and cons of publically reporting these data sets.
40.0
Does not demonstrate understanding of the process of evaluating hospital quality data against competitors or the issues of public reporting. Does not demonstrate critical thinking and analysis of the material.
Demonstrates only minimal understanding of the process of evaluating hospital quality data against competitors or the issues of public reporting. Demonstrates only minimal abilities for critical thinking and analysis.
Demonstrates knowledge of the process of evaluating hospital quality data against competitors and the issues of public reporting, but has some slight misunderstanding of the data and how to interpret it. Provides basic critical thinking and analysis. Does not include examples or descriptions.
Demonstrates acceptable knowledge of the process of evaluating hospital quality data against competitors and the issues of public reporting (in your own words). Develops an acceptable analysis of the pros and cons. Utilizes some examples.
Demonstrates thorough knowledge of the process of evaluating hospital quality data against competitors and the issues of public reporting. Clearly develops a strong analysis of the pros and cons. Introduces appropriate examples.
Integrates information from outside resources into the body of paper.
30.0
Does not use references, examples, or explanations.
Provides some supporting examples, but minimal explanations and no references.
Supports main points with examples and explanations and includes few references to support claims and ideas.
Supports main points with references, explanations, and examples. Analysis and description are direct, competent, and appropriate of the criteria.
Supports main points with references, examples, and full explanations of how they apply. Thoughtfully analyzes, evaluates and describes major points of the criteria.
Organization and Effectiveness
20.0

Assignment Development and Purpose
7.0
Paper lacks any discernible overall purpose or organizing claim.
Thesis and/or main claim are insufficiently developed and/or vague; purpose is not clear.
Thesis and/or main claim are apparent and appropriate to purpose.
Thesis and/or main claim are clear and forecast the development of the paper. It is descriptive and reflective of the arguments and appropriate to the purpose.
Thesis and/or main claim are comprehensive. The essence of the paper is contained within the thesis. Thesis statement makes the purpose of the paper clear.
Argument Logic and Construction
8.0
Statement of purpose is not justified by the conclusion. The conclusion does not support the claim made. Argument is incoherent and uses noncredible sources.
Sufficient justification of claims is lacking. Argument lacks consistent unity. There are obvious flaws in the logic. Some sources have questionable credibility.
Argument is orderly, but may have a few inconsistencies. The argument presents minimal justification of claims. Argument logically, but not thoroughly, supports the purpose. Sources used are credible. Introduction and conclusion bracket the thesis.
Argument shows logical progression. Techniques of argumentation are evident. There is a smooth progression of claims from introduction to conclusion. Most sources are authoritative.
Clear and convincing argument presents a persuasive claim in a distinctive and compelling manner. All sources are authoritative.
Mechanics of Writing (includes spelling, punctuation, grammar, language use)
5.0
Surface errors are pervasive enough that they impede communication of meaning. Inappropriate word choice and/or sentence construction are used.
Frequent and repetitive mechanical errors distract the reader. Inconsistencies in language choice (register), sentence structure, and/or word choice are present.
Some mechanical errors or typos are present, but are not overly distracting to the reader. Correct sentence structure and audience-appropriate language are used.
Prose is largely free of mechanical errors, although a few may be present. A variety of sentence structures and effective figures of speech are used.
Writer is clearly in command of standard, written, academic English.
Format
10.0

Paper Format (Use of appropriate style for the major and assignment)
5.0
Template is not used appropriately, or documentation format is rarely followed correctly.
Appropriate template is used, but some elements are missing or mistaken. A lack of control with formatting is apparent.
Appropriate template is used. Formatting is correct, although some minor errors may be present.
Appropriate template is fully used. There are virtually no errors in formatting style.
All format elements are correct.
Research Citations (In-text citations for paraphrasing and direct quotes, and reference page listing and formatting, as appropriate to assignment and style)
5.0
No reference page is included. No citations are used.
Reference page is present. Citations are inconsistently used.
Reference page is included and lists sources used in the paper. Sources are appropriately documented, although some errors may be present
Reference page is present and fully inclusive of all cited sources. Documentation is appropriate and citation style is usually correct.
In-text citations and a reference page are complete and correct. The documentation of cited sources is free of error.
Total Percentage 100
Study Materials
1)Tooling up to prevent Never Events
Tooling up to prevent Never Events.
patient connection
OPERATing ROOm
tooling up to prevent never events
by Susan Cantrell, ELS
H ealthcare changed dramatically in October 2008, when the Centers for Medicare & Medicaid Services
(CMS) stopped reimbursing providers for many expenses related to certain preventable medical events, also referred to as Never Events. Private insurers have followed suit.
Never Events are exactly what the name implies: serious, preventable medical mis- takes that should NEVER happen. According to the Agency for Healthcare Research and Quality,1 Never Events include, but are not limited to:
• unintended retention of a foreign object in a patient after surgery or other procedure • patient death or serious injury associated
with a medication error
• surgery or other invasive procedure per-
formed on the wrong body part or on the
wrong patient
• patient or staff death or serious injury
associated with a burn incurred from any source in the course of a patient-care process in a healthcare setting
• catheter-associated urinary tract infection
• vascular catheter-associated infection
• certain surgical-site infections
Furthermore, new research published last month, led by Martin Makery, Professor of Surgery and Health Policy
and Management at Johns
and even post traumatic stress disorder, after being involved in a patient death due to error.”
never events have a
rippling effect
Nicole Wilson, RN, MSN, CPHIMS, Clinical Marketing Manager, Medication Manage- ment Solutions, BD, pointed out the domino effect that nonreimbursement by CMS has when Never Events happen. “The intent is to improve quality and reduce healthcare costs by forcing hospitals to improve practices,” said Wilson. “This has had a positive impact, as hospitals are paying closer attention to quality by making improvements through education, implementation of technology, and changes to policies and procedures.”
Latisha Richardson, MSN, BSN, RN, Clinical Consultant, Ansell, discussed other impacts that Never Events are having on medical facilities and patients. “In essence, hospitals are going to have to absorb these additional costs, affecting the overall operat- ing budget of the facility and the available resources to maintain quality patient care,” said Richardson. “While Never Events are rare, when they do occur, they are often devastating in both clinical and financial terms. From 2004 to 2015, The Joint Commis- sion reported a total of 1,196 wrong-patient, wrong-site, wrong-procedure incidents and 462 medication-error sentinel events.1 Over the past 12 years, 71 percent of Never Events reported to The Joint Commission were fatal.2
“Patients and their families must cope with physical and/or psychological injury, in addition to potential changes to personal financial standing,” Richardson added. “Pub- lic reporting of these events has increased hospital accountability and intensified the pressure to eliminate these occurrences entirely.”
Joe Guido, Vice President, Commercial Marketing and Business Development, Invu- ity Inc., suggested that public reporting of Never Events places additional pressure on medical facilities to raise the bar on quality care for their patients. Guido referred to a let- ter written by CMS and the National Quality Forum (NQF) and addressed to state Medic- aid directors in 2008. According to the letter, which places the responsibility for Never Events squarely on the shoulders of medical
Hopkins University, shows
9.5 percent of all deaths each
year in the U.S. are caused
by medical error — the third
leading cause of death behind
heart disease and cancer, not
respiratory disease as current health statistics indicate.
In an open letter to Dr. Thomas Frieden, Director of the Centers for Disease Control and Prevention (CDC), Makery and his team urged for a change in the way the CDC collects annual vital health statistics, which currently tallies causes of death based only on disease, morbid conditions, and injuries.
“Drawing on reliable data, deaths from care, rather than from the disease that brought the person into care, should be ad- dressed with the same resources and vigor as other scientific endeavors,” the letter said. “We need more honest conversations about the problem. It would also help the many clinicians who cope with the mental trauma,
• hpnonline.com
Martin Makery
Page 16
critical drugs for hospital eRs remain in short supply
At some hospitals, posters on the wall in the emergency department list the drugs that are in short supply or unavailable, along with recom- mended alternatives.
The low-tech visual aid can save time with critically ill patients, allowing doctors to focus on caring for them rather than doing research on the fly, said Dr. Jesse Pines, a professor of emergency medicine and director of the Office for Clinical Practice Innovation at the George Washington University School of Medicine and Health Sciences. He has studied the problems created by shortages.
The need for such workarounds probably won’t end anytime soon. According to a new study, shortages of many drugs that are essen- tial in emergency care have increased in both number and duration in recent years even as shortages for drugs for non-acute or chronic care have eased somewhat. The shortages have persisted despite a federal law enacted in 2012 that gave the Food and Drug Administration regulatory powers to respond to drug short- ages, the study found.
For this report, researchers analyzed drug shortage data between 2001 and 2014 from the University of Utah’s Drug Information Ser- vice, which contains all confirmed national drug shortages, according to the study.
They divided the drugs into acute and non- acute categories. Acute-care drugs were those used in the emergency department for many of the urgent and severe conditions handled there and include remedies such as pain medications, heart drugs, saline solution and electrolyte products.
Overall, the study found that 52 percent of the 1,929 shortages during the time period studied were for acute-care drugs. Follow- ing passage of the federal law in 2012, the number of active shortages of non-acute care drugs began to decline for the first time since 2004, but there was no corresponding dropoff in shortages of drugs that emergency depart- ments and intensive care units rely on, the researchers reported.
Shortages of the drugs for emergency care lasted longer as well, the study found. Half of the shortages of drugs for acute care lasted longer than 242 days, compared with 173 days for non-acute care drugs.
Seventy percent of the drugs that were difficult to get were injectable drugs, which emergency departments rely on to a much greater degree than other types of providers. The most common acute-care drugs affected were those to fight infections, such as anti- biotics; those that affect the central nervous system, including painkillers and sedatives; and the drugs that suppress or stimulate the autonomic nervous system, which controls heart and breathing rates.
14 June 2016 • HEALTHCARE PuRCHAsing nEWs

OPERATing ROOm
facilities, Never Events are “errors in medi- cal care that are of concern to both the public and health care professionals and providers, clearly identifiable and measurable (and thus feasible to include in a reporting system), and of a nature such that the risk of occurrence is significantly influenced by the policies and procedures of the health care organization.”
Tools for preventing
Never Events
The list of Never Events is long and includes errors so awful that one wonders how they could even happen.1 The truth is they can happen too easily, which maybe shouldn’t be so surprising after all when patients are re- ceiving care from multiple healthcare work- ers (HCWs) who are often
extremely busy and stressed
on several fronts. Sometimes miscommunication is the
problem. Distraction can be
a contributor. A slip of the
finger at the wrong time can
result in catastrophe.
Following best practices
and having the right tools for the right time and situation can help prevent these and other mistakes. “It is critical for periopera- tive teams and healthcare facilities to remain aware of the tools and resources available to- day to help prevent the risk of Never Events,” urged Richardson.
Getting the basics correct is critical, and patient admissions is the place to start. One of the first things a patient experiences upon admission is having an identification band applied to his or her wrist. “Wristbands are the first barrier to the occurrence of many Never Events,” said Robert Chadwick, Presi- dent, Endur ID Inc., a company that takes patient identification wristbands to another level. “When you review the list of the NQF’s Never Events, you begin to realize that many of these events can be triggered by the simple misidentification of a patient. Healthcare has come to rely on the seemingly simple patient identification wristband for this function.”
Chadwick explained that, whereas most wristbands display basic identifying factors, Endur ID saw the need for more security. “To the standard bands we added barcodes, for medication management; photos, which assist in making sure the correct band is af- fixed to the correct patient; color-coded alerts for allergies; [risk of
“In addition to providing all the needed information, we developed tough and du- rable products,” continued Chadwick. “If a band was not waterproof or if it fell off the patient, their identity could not be verified. If a bar code did not scan, then barcode-based medication management would fail. With the average cost of a wristband being under 40 cents, the justification for a high-quality wristband is simple when compared with the suffering and cost associated with a Never Event.”
Ansell’s SANDEL line also addresses the potential for medication errors. “The SAND- EL Correct Medication Labeling System helps prevent the risk of costly medication labeling errors and aids in compliance with The Joint
primary goals for all members of the health- care team, not just cost savings.”
Wilson explained how BD addresses prevention of medication errors related to infusion pumps, noting that all it takes is one wrong keystroke when programming an infusion pump to cause a Never Event. “Companies like BD are trying to help through innovative products such as Alaris EMR interoperability,” said Wilson. “The wireless two-way connectivity between the infusion pump and the electronic medical record (EMR) pre-populates the pump with the ordered parameters directly from the EMR, eliminating manual key presses and inherent errors. The connection between Alaris and the EMR is bi-directional; there- fore, time-stamped infusion data is sent from the pump back to the EMR. This includes ac- curate start and stop times, which are neces- sary for complete outpatient reimbursement of infusions.”
BD Alaris EMR interoperability
Peace of mind in preventing medical er- ror can sometimes come with a price, but Wilson advised, “The cost to purchase and implement a solution like Alaris EMR in- teroperability can be offset by the financial benefit it provides. In 2006, the cost to treat a medication error was $8,750.5 By prevent- ing medication errors, the hospital can avoid
these associated costs. These tech- nologies can also drive increased revenue.”
Wilson highlighted how one 286-bed level-II trauma center in Montana implemented Alaris EMR interoperability to stream- line its processes and save money. “The hospital reduced the num-
] falling, and so on. Not only is the staff alerted, but those with these risks can be identified easily without wearing many extra wrist- bands.
Endur ID identification band system
a count is about to begin.” Richardson also addressed cost. “With over 4,000 surgical Never Event malpractice claims occurring annually,4 facilities must weigh the financial impact of a single Never Event versus the minimal cost of a preventative product. [Reducing] Never Events should be one of the
ber of key strokes needed to program each infusion from 15 to two (86 percent), greatly decreasing the opportunities for error,” said Wilson. “Self-reported safety events related to all infusion-pump programming were reduced from three to one. In the first month, the hospital decreased lost charges for infu- sions from $980,000 to $610,000. This equated to roughly $370,000 in incremental revenue.”
Invuity offers surgical instruments with built-in light sources that enable surgeons to see the surgical cavity more clearly, thus making it less likely that a foreign object is missed before closing the surgical site. “Invu- ity’s minimal access surgical devices provide
SANDEL Correct Medication Labeling System
Commission’s Na- tional Patient Safety Goals,”3 said Rich- ardson. “A variety of medication label- ing kits are avail- able and contain everything needed to label medication
on the sterile field. Kits include items such as preprinted labels, colored ID flags with matching syringe strips, a specimen zone, permanent markers, and skin markers.”
To prevent surgery-related Never Events, Richardson said “In compliance with The Joint Commission’s Universal Protocol for preventing wrong-site surgery, SANDEL TIME OUT Skin Markers are used to mark the correct surgical site on a patient’s skin prior to a procedure.
“SANDEL TIME OUT Beacons serve as a prominent reminder for the surgical team to comply with The Joint Commission’s Uni- versal Protocol.
It can be placed
over the surgical
site, mayo stand,
or back table,”
explained Rich-
ardson. “TIME
OUT Beacons
are bright orange
and highly recognizable. The Count In Prog- ress Beacon is designed to help reduce the risk of retained surgical items in the OR by eliminating distractions during the counting process. It is bright orange and highly recog- nizable, helping notify the surgical team that
SANDEL TIME OUT Beacon
16 June 2016 • HEALTHCARE PuRCHAsing nEWs • hpnonline.com
Page 18

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OPERATING ROOM
direct visualization
within the surgical
cavity,” said Guido.
“Products include il-
luminated retractors,
hand-held illuminated
devices, and drop-in il-
luminators. This direct
visualization enables
thorough inspection
of the surgical cavity
to identify and retrieve
foreign objects that
may have otherwise been left behind in the wound.”
An article written by Anderson-Drevs last year underscores the idea with a quote by Ronald Wyatt, MD, Medical Director of The Joint Commission’s Office of Quality and Patient Safety: “Another newer technology to consider is proprietary photonics technol- ogy. This provides thermally cool intracavity illumination, which greatly improves visu- alization of the surgical cavity and allows a thorough visual inspection both
for reconciliation [and can] scan the patient and surgical site, detecting tagged sponges, ensuring nothing is left behind.”
Cross-contamination can be a factor in hospital-acquired infection Never Events, and one proven way to reduce it is to practice proper hand hygiene consistently. Unfortunately, compliance is not where it should be, and the traditional method of tracking compliance, observation, is inher- ently flawed.
Jason Burnham, Associate Director, Marketing, Halyard Health, said automatic monitoring of compliance can save staff hours on audits and reporting so that their time can be “better allocated to solving the Never Events that have an impact on patients and cost of care.”
He said Halyard’s AiRISTA Hand Hy- giene Monitoring technology provides 24/7 monitoring, reporting, alerting, and feedback to individuals automatically with sensor technology, potentially relieving staff of hundreds of hours of labor.
during surgery and before closing.”6 Guido added “Studies show total cost of care related to an unintended retained foreign object is $160,000 to $200,000. Cost includes legal defense, indemnity payments, and surgical costs not reimbursed by CMS.” The Invuity instruments are valuable prevention tools he as-
AiRISTA Hand Hygiene Monitoring technology, from Halyard Health
Referring to an urban hospital on the East Coast, Burnham said the facility achieved a 38 percent improve- ment in hand-hygiene compliance in just three months using the AiRISTA Hand Hygiene Monitoring
serted, referring to The Joint Commission’s “Sentinel Event Alert on Preventing Unin- tended Retained Foreign Objects.”7
Unlike the thermal hazards associated with traditional fiber optics, the Invuity de- vices operate on a proprietary thermally cool illumination technology to help decrease the chance of patient burns and surgical fire. “Surgical burns represent a risk for hospitals, but occur very infrequently,” said Guido. “In the event that the hospital encounters a lawsuit, malpractice insurance covers the claim, but the surgeon’s malprac- tice insurance premium, which is typically paid by the hospital, increases.”
Haldor USA Inc. also of- fers a product to help
prevent retention of
foreign objects, in-
cluding sponges. Pete Koste, Vice President, Strategic Accounts, briefly described howitworks.“Us-
ing RFID technol-
o g y , H a l d o r ’ s
ORLocate can eliminate
the risk and liability associated with retained surgical sponges. ORLocate is capable of identifying and counting individual sponges
system. “In numerous publications of data provided directly from hospitals, hand- hygiene improvement using electronic monitoring correlated to up to a 72 percent reduction in infections and up to $476,000 in direct cost savings.”
Burnham added that, as CMS and private insurers tighten quality expectations on Never Events, the conditions they consider for quality metrics are expanding annually. This leaves many hospitals addressing last year’s metric within the scope of potential penalty, which adds an additional strain on quality and infection-control departments that goes beyond their normal workload.
Eikon LT, the first non-conductive illuminated retractor system, by Invuity Inc.
“Infection-control and qual- ity departments are already constrained with manual monitoring, rounding, and severe gaps in au- tomation to help them with efficient use of time,” said Burnham. “Staff find them- selves spending a majority of time documenting and processing, leaving little time for problem-
solving. ” HPN
Visit www(dot)hpnonline(dot)com/inside/2016-06/1606-OR-NeverEvents. html for references.
Haldor’s ORLocate uses RFID to prevent retention of surgical sponges.

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2)
LB:
BY STEVEN JOFFE AND ALAN WERTHEIMER
Determining Minimal Risk for Comparative Effectiveness Research
ecisions about whether or not a study involves Dminimal risk structure critical procedural and
substantive determinations by institutional re- view boards (IRBs). In particular, minimal risk is a nec- essary—though not a sufficient—condition for decid- ing whether a study may qualify for expedited review and whether a waiver of the requirement for informed consent might be permissible. In addition, the determi- nation that a study involves minimal risk has important implications for how investigators should describe it to prospective research participants in consent documents and during the consent process.
Judgments about minimal risk are particularly challenging in the setting of comparative effectiveness clinical trials, in which the procedures that participants undergo and the risks they face commonly mirror those inherent in ordinary medical care. Depending on how one counts the risks of the ordinary medical care that comparative effectiveness trials incorporate, these trials may be seen as either high- or low-risk endeavors. The recent controversy over the study called the Surfactant, Positive Pressure, and Oxygénation Randomized Trial (SUPPORT)—which randomized extremely premature infants to receive oxygen therapy titrated to achieve blood oxygen saturations at either the low or the high end of the range considered to be standard of care outside the trial—highlights contemporary uncertain- ties about risk assessment in comparative effectiveness trials.^ The ongoing réévaluation of oversight models for research conducted within learning health care sys- tems, with questions raised about whether regulations governing protection of human subjects in research unjustifiably burden lower-risk learning activities,^ further demonstrates the need for clarity regarding risk
Steven Joffe and Alan Wertheimer, "Determining Minimal Risk for Compara- tive Effectiveness Research," IRB: Ethics & Human Research 2014;36(3):16- 18.
assessment in comparative effectiveness trials.
The importance of minimal-risk determinations is
heightened in cluster-randomized trials, a methodologi- cal mainstay of comparative effectiveness research. Such trials, which involve randomization at the group rather than the individual level, pose special challenges for research oversight. 3 Because interventions may be environmental in nature or may be delivered across an entire unit, institution, or community, it may not be possible to seek informed consent from participants
in these studies. In a review of articles describing the results of cluster-randomized trials, Giraudeau and col- leagues found that when the intervention was delivered at the cluster level, participant consent—often encom- passing collection of study data but not delivery of the intervention itself—was obtained in 67% of trials.4 As an example, the recent study. Randomized Evaluation of Decolonization vs. Universal Clearance to Eliminate MRSA (REDUCE MRSA)—which compared three approaches to decontamination of patients in inten- sive care units in order to prevent hospital-acquired methicillin-resistant Staphylococcus aureus infections— necessitated a waiver of the requirement for written informed consent. 5 When a waiver of consent is needed for methodological or logistical reasons, the research cannot proceed unless the relevant IRB first determines that the trial involves minimal risk.
According to federal regulations governing research with humans (the Common Rule), minimal risk means that "the probability and magnitude of harm or dis- comfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests" (for brevity, we will call this the "daily life standard").^ The critical phrase "anticipated in the research" appears to direct
MAY-JUNE 2014
IRB: ETHICS & HUMAN RESEARCH
IRBs to consider all the risks of the study interventions in deciding whether or not a trial involves minimal risk. On this reading, few comparative effectiveness trials of drugs, devices, and other biomédical interventions will qualify as minimal risk. We contend, however, that this reading is mistaken.
Consider the Clinical Antipsychotic Trials of In- tervention Effectiveness (CATIE) study. The trial compared the effectiveness of several antipsychotic medications that are widely used and approved by the Eood and Drug Administration (EDA) for the treat- ment of schizophrenia.7 Common, serious toxicities of these medications include movement disorders (extra- pyramidal signs and tardive dyskinesia), weight gain, and altered glucose and lipid metabolism. The trial included neither a placebo arm nor additional research procedures beyond those required for standard care. How should IRBs reviewing this trial evaluate its risks? Under one approach, an IRB might seek to assess the absolute risks of the study interventions. Using this approach, the IRB would examine the toxicity profile of each drug and then judge whether the identified risks exceeded the daily life standard specified in the Com- mon Rule. It would undoubtedly determine that the trial involves greater than minimal risk.
Alternatively, an IRB might seek to assess the incre- mental risks of the study interventions, as compared with the risks of the treatments that study participants would likely receive as patients in the clinical set-
ting.^ Under this approach, the IRB would then judge whether the incremental risks, if any, exceeded the daily life standard. Because all regimens used within the trial would themselves be standard, the incremental approach might reasonably yield the conclusion that, despite the substantial risks of the individual antipsy- chotic medications, trial participation would never- theless involve minimal risk. This conclusion entails neither that the trial should undergo expedited review nor that it would qualify for a waiver of the require- ment for informed consent. However, it does suggest that investigators presenting the trial to prospective research participants might accurately describe study participation, in both consent forms and discussions, as involving no more than minimal risk.
Two lines of regulatory evidence support the incre- mental approach to determining minimal risk. Eirst, the Common Rule states, "In evaluating risks and benefits, the IRB should consider only those risks and benefits that may result from the research (as distinguished
from risks and benefits of therapies subjects would receive even if not participating in the research)."? Fol- lowing this logic, risks of standard therapies that sub- jects would receive outside the research are the proper baseline against which the risks of the trial intervention should be evaluated. If the IRB determines that the incremental risks of trial participation, over and above receipt of usual therapy outside the trial, do not exceed the daily life standard, then it can justifiably conclude that the trial involves only minimal risk.
Second, consider the process the Office for Human Research Protections (OHRP) in the Department of Health and Human Services (DHHS) outlines for deter- mining which studies are eligible for expedited rather than full-board IRB review. A study must satisfy two conditions to be approved under expedited procedures: it must be judged to involve no more than minimal risk, and all study procedures must fit within one or more of
XRB determinations that many paradigmatic comparative effectiveness trials satisfy the minimal-risk standard can decrease markedly regulatory burdens these trials face and can promote accurate disclosures about risk, without substantively compromising research protections afforded to participants.
the categories on a list published by OHRP/DHHS.i° The purpose of the list is to enumerate classes of re- search that are presumptively minimal risk. Category
1 includes "research on drugs for which an investiga- tional new drug application . . . is not required," which typically holds true when the drug's use in the trial
is consistent with its EDA-approved indication. That the use of drugs (or devices) in accordance with their labeled indications is included on the list of procedures eligible for expedited review suggests that OHRP/ DHHS views such studies as presumptively minimal risk. This presumption can be understood only if one adopts the incremental approach.
Determining that many paradigmatic comparative effectiveness trials satisfy the minimal-risk standard can decrease markedly the regulatory burdens that these trials face and can promote accurate disclosures about risk, without substantively compromising the protec- tions afforded to research participants. In making this determination, IRBs should assess the incremental risks
IRB: ETHICS & HUMAN RESEARCH
MAY-JUNE 2014
m
of the interventions in the study, as compared with the risks of standard treatments that participants would experience if they did not join the trial. IRBs should then consider whether those incremental risks exceed the daily life standard specified in the Common Rule. This approach to determining minimal risk is consistent with the letter and spirit of human subjects regulations while protecting subjects against exposure to excess research-related risk.
• Steven Joffe, MD, MPH, is Emanuel and Robert Hart Associate Professor of Medical Ethics and Health Policy, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA; Alan Wert- heimer, PhD, is professor emeritus of Political Science, University of Vermont, Burlington,VT.
Acknowledgments
Dr. Joffe's work on this project was supported by a grant from the Greenwall Foundation through the Gre- enwall Faculty Scholars Program. The Greenwall Foun- dation had no role in the development of the arguments presented here; the preparation, review, or approval of
the manuscript; or the decision to submit the manuscript for publication. The authors wish to thank Scott Halpern, MD, PhD, for helpful comments on an earlier draft of this manuscript.
Disclosure
Dr. Joffe was a paid member of a Data Monitoring Committee for Genzyme/Sanofi until November 2012. He is currently an expert witness for counsel representing Johns Hopkins University in Fartlow v. Johns Hopkins University. Dr. Wertheimer has no conflicts of interest to declare.
References
1. Drazen JM, Solomon CG, Greene MF. Informed consent and SUPPORT. NEJM 2oi3;368:i929-i93i; Hudson KL, Guttmacher AE, Collins FS. In support of SUPPORT—a view from the NIH. NEJM 2oi3;368:2.349-235i; Network Support Study Group of the Eunice Kennedy Shriver NICHD Neonatal Research Network, Carlo WA, Finer N N , et al. Target ranges of oxygen saturation in extremely preterm infants. NEJM 2Oio;362:i959-i969; Wilfond BS, Mag-
nus D, Antommaria AH, et al. The OHRP and SUPPORT. NEJM
20i3;368(25):e36; and Macklin R, Shepherd L, Dreger A, et al. The OHRP and SUPPORT—another view. NEJM zoiy,^6s{z):ei.
2. Faden RR, Kass NE, Goodman SN, et al. An ethics frame- work for a learning healthcare system: A departure from tradi-
tional research ethics and clinical ethics. Hastings Genter Report 2oi3;43(i):Si6-S27; Kass NE, Faden RR, Goodman SN, et al. The research-treatment distinction: A problematic approach for determin- ing which activities should have ethical oversight. Hastings Genter Report 2oi3;43(i):S4-Si5; Kass NE, Faden RR, Tunis S. Addressing low-risk comparative effectiveness research in proposed changes to US federal regulations governing research. JAMA 20121307:1589- 1590; Largent EA, Joffe S, Miller FG. Can research and care be ethi- cally integrated? Hastings Genter Report 20ii;4i(4):37-46.
3. See Weijer C, Grimshaw JM, Eccles MP, et al. The Ottawa statement on the ethical design and conduct of cluster randomized trials. PLoS Medicine 2oi2;9(ii):eiooi346; Mazor KM, Sabin JE, Goff SL, et al. Cluster randomized trials to study the comparative effectiveness of therapeutics: Stakeholders' concerns and recommen- dations. Pharmacoepidemiology and Drug Safety 2OO9;i8(7):554- 561; McRae AD, Weijer C, Bink A, et al. When is informed consent required in cluster randomized trials in health research? Trials 2oii;i2:2O2; Eldridge SM, Ashby D, Feder GS. Informed patient consent to participation in cluster randomized trials: An empirical exploration of trials in primary care. Glinical Trials 2OO5;2(2):9i-98; Sim J, Dawson A. Informed consent and cluster-randomized trials. American Journal of Public Health 2oi2;io2(3):48o-485; Chaudhry SH, Brehaut JC, Grimshaw JM, et al. Challenges in the research ethics review of cluster randomized trials: International survey of investigators. Glinical Trials 2oi3;io(2):257-268.
4. Giraudeau B, Caille A, Le Gouge A, et al. Participant informed consentinclusterrandomizedtrials.PLoSONE2oi2;7(7):e4O436.
5. Huang SS, Septimus E, Kleinman K, et al. Targeted ver- sus universal decolonization to prevent ICU infection. NEJM 2013:368:2255-2265.
6. U.S. Department of Health and Human Services. Protection of Human Subjects. 45 GFR 46.
7. Lieberman JA, Stroup TS, McEvoy JP, et al. Effectiveness of antipsychotic drugs in patients with chronic schizophrenia. NEJM 2OO5;3 53:1209-1223.
8. Wendler D, Miller FG. Assessing research risks systematically: The net risks test. Journal of Medical Ethics 2oo7;33(8):48i-486; Rid A, Wendler D. A framework for risk-benefit evaluations in biomédi- cal research. Kennedy Institute of Ethics Journal 20ii;2i(2):i4i- 179; Morris MC, Nelson RM. Randomized, controlled trials
as minimal risk: An ethical analysis. Gritical Gare Medicine
9. See ref. 6, U.S. Department of Health and Human Services 4 5 CFR46.iii(a)(2).
10. Office for Human Research Protections. Categories of research that may be reviewed by the Institutional Review Board (IRB) through an expedited review procedure. Federal Register 1998:63(216):6O364-60367. http://vifvirw(dot)hhs(dot)gov/ohrp/policy/expe- dited98.html.
MAY-JUNE 2014
IRB: ETHICS & HUMAN RESEARCH
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3)
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4) SPOTLIGHT ON SAFETY [BY CHRISTINE CASCIO, BSN, RN, OCN®, CONTRIBUTOR]
The Role of Patient Spirituality in a Culture of Safety
WHEN WE THINK OF A CULTURE OF SAFETY, we often think of a patient’s physical needs. But in the process
of performing our everyday tasks, a patient’s psychosocial needs can often be overlooked. Although prioritizing physical elements of safety is critical
to our patients’well-being, it’s also important to remember to view health care with a multidisciplinary approach: as something where all patient concerns are addressed to the best of our ability.
When was the last time you tried to understand the patient’s perspective of his most critical needs? It’s important to be proactive and advocate for our patients’ psychosocial needs, including their faith and spiritual needs, rather than only focusing on their physical ailments.
I learned this lesson firsthand from a patient who was very ill and bedbound but refused all care. He insisted that he needed to leave the hospital and come right back. When I asked him exactly
why he was refusing care and wanted to leave, he told me that he wanted to get married. I knew this patient was scheduled for surgery later that week. I immediately thought of all of the resources we could use to help meet his desire to get married. Working
was very appreciative and told us that it was the happiest day of his life.
Once he experienced this sense of control over his own life, he no longer appeared to be in distress and was more than willing to be compliant with his treatment. This also eased his nerves prior to surgery and he was able to undergo it as scheduled.
Sharing this moment with this patient and his family reminded me why I love my job as an oncology nurse. We can
all truly make a difference in quality of care by addressing our patients’wishes. It’s important to take a step back from medical needs at times to focus on patients’personal needs.
When patients are admitted for
an extended time, they may develop emotional distress. I’m sure we’ve all taken care of patients who have reported feeling imprisoned in the hospital and have a sense of helplessness and a loss
of control of their situation. This can
be detrimental to their psychosocial well-being and decrease their desire
to want to comply with treatment. Distress screening tools are becoming more widely used to assess emotional distress in the oncology population (Vodermaier, Linden, & Siu, 2009).
24 ONS CONNECT AUGUST 2016
in collaboration with the nurses,
doctors, social worker, clergy, and the
patient’s significant other and family
members, we were able to coordinate
his plan of care and provide him with
the opportunity to get married in his
hospitalbed.Thepatient’sfamilywas Togetherwecanproactivelyprevent
able to witness an intimate Catholic ceremony in the privacy of his room. The patient and his new wife held hands and recited their vows as they exchanged rings they had borrowed from other family members.
It may not have been under the most perfect circumstances, but it was perfect for them. I’ll never forget the joy that patient exuded after he was pronounced a married man to the love of his life. He
emotional distress through ongoing psychological assessments of our patients (ONS, 2016). ■
ONS. (2016). Psychoeducation/psychoeducational interventions for anxiety. Retrieved from https:// www(dot)ons(dot)org/intervention/psychoeducation psychoeducational-interventions-3
Vodermaier, A., Linden, W., & Siu, C. (2009). Screening for emotional distress in cancer patients: A systematic review of assessment instruments. Journal of the National Cancer Institute, 101, 1464-1488. doi: 10.1093/jnci/ djp336
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