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HEALTHCARE IN THE USA:
WHAT CLINICIANS NEED TO KNOW!
Russ Nassof, Esq
Russell Nassof is a paid consultant of Ethicon US, LLC.
This promotional educational activity is brought to you by Ethicon US, LLC.
Healthcare Wheel of Fortune
Program
• The Business of Medicine
• Background
• Solution
• Affordable Care Act (ACA)
• Problems
• Why Should We Care?
• The Legal Stuff
• Importance of Product Selection
• Liability Minimization
The Business of Medicine
The Business of Medicine
• DO NO HARM (Clinician) versus
• MAKE $$$$ (Lawyers)
The Business of Medicine
All too often… Brings the Bad News!
The Business of Medicine
All too often… Never Invited to Lunch!
The Business of Medicine
All too often… Invited AFTER the Adverse Event
The Business of Medicine
All too often… How We Feel At the End of the Day!
The Business of Medicine
The Solution:
The Business of Medicine
Creating an Accountable Care Org. (ACO)
Personnel Shortages
Technology
Population Health Management
Physician-Hospital Relations
PATIENT SATISFACTION
Care for the uninsured
PATIENT SAFETY AND QUALITY
GOVERNMENT MANDATES
HEALTHCARE REFORM IMPLEMENTATION
FINANCIAL CHALLENGES*
*http://www.ache.org/pubs/research/ceoissues.cfm. Accessed 2/18/16
Where did This Come From???
Pronovost and Prevention
The Problem with Zero
• Umschied – ”As many as 33% of all cases of CLABSI and almost 50% of SSI and VAP were not preventable.”*
What is Preventable = Moving Target
• When Nothing was Preventable there was No Liability• *Umscheid CA, Mitchell MD, Doshi JA, Agarwal R, Williams K, Brennan PJ. Estimating
the proportion of healthcare-associated infections that are reasonably preventable and the related mortality and costs. Infect Control Hosp Epidemiol. 2011 Feb;32(2):101-14.
• *Umac
Preventability and Liability
Why?
The Background
The More That is
Preventable…
The more we have to report to
regulators;
The more potential liability
may be imposed.
The more insurance
companies do not have to pay; and,
And Today- even adverse
events such as falls are
deemed to be preventable
and the list grows every
year…
The Problem
• Regulating Healthcare vs Clinical Practice?
The Solution?
• Fee for Service vs. Pay for Performance
• 2001- NQF and the “Never Events”-29 events
• Terminology is problematic but caught on with payors, regulators, PSOs,
state health organizations, etc.
• Serious, largely preventable patient safety incidents that should not occur
with appropriate preventive measures (includes contaminated device
injury/illness/death)
• List has grown slowly from inception
The Solution?
• Fee for Service vs. Pay for Performance
• 2008- Center for Medicare/Medicaid Services (CMS)- “To encourage
hospitals to prevent certain HACs not POA.”*
• Deficit Reduction Act (DRA)- Hospitals will no longer receive the
differential (enhanced payment) when the sole reason for the
differential was REASONABLY PREVENTABLE through adherence to
evidence based guidelines.*
• POA conditions become critical
• 11 conditions included (some overlap with NQF “Never Events” list)
• Includes Vascular Catheter-associated Infections, catheter-associated
urinary tract infections, falls, and pressure ulcers (stages III and IV)**
*https://www.fojp.com/sites/default/files/infocusFall10.pdf. Accessed 2/20/16
**https://www.cms.gov/medicare/medicare-fee-for-service-payment/hospitalacqcond/hospital-acquired_conditions.html. Accessed
2/20/16
The Solution?
The ACA• Fee for Service vs. Pay for Performance
• 2010- Patient Protection and Affordable Care Act(ACA)-ObamaCare
• 16.4 million newly insured with 8 million enrolled in a marketplace plan*
• Uninsured fell from 18% to 9.2% as of 8/15**
• Financial rewards/penalties based on quality measure attainment
established by CMS (including HAIs)
• New Goal- 30% of direct payments to doctors, hospitals, and other
providers will be through alternative payment models
*http://www.hhs.gov/healthcare/fact-and-features/fact-sheets/aca-is-working/index.html. Accessed 2/20/16
**http://www.dailykos.com/story/2015/11/5/1445323/-CDC-Uninsured-rate-lowest-ever. Accessed 2/20/16
The ACA
• Fee for Service vs. Pay for Performance
More changes to CMS payments
I. Hospital Readmissions Reduction Program
II. Hospital Acquired Conditions (HACs)
III. Hospital Value Based Purchasing
IV. Hospital Inpatient Quality Reporting Program
ALL 4 PROGRAMS WORK IN TANDEM TO INCENTIVIZE
IMPROVED PATIENT OUTCOMES/SATISFACTION WITH
LOWER COST
The ACA
• Why Should We Care about the ACA?
• Focus on improving patient outcomes
• Improved outcomes will result from reduction in vascular catheter
related adverse events
• Reduction in vascular catheter adverse events will result from
selection of the right product for the right patient at the right time
• Government will penalize those failing to achieve improved
outcomes and will reward those that are successful
• Bottom Line- INCREASED SCRUTINY OF VASCULAR CLINICIAN
PRACTICE
The ACA
• Changes to CMS
I. Hospital Readmission Reduction Program
• Penalties (3% in 2015) on hospitals that have excess readmissions
(above the national average) for
• Cardiac- AMI/Heart Failure
• Pulmonary-Pneumonia/COPD
• Orthopedic-Total Hip/Knee Arthroplasty
• Potential for more to be added-CABG/percutaneous coronary intervention
• Some allowances now made for demographics, comorbidities, patient
frailties (risk adjustment)*
* The Advisory Board Company, Healthcare Industry Committee, Hospital Readmissions Reduction Program, C-Suite Cheat Sheet Series, August 2013.
Accessed 2/21/16
The ACA
• Changes to CMS
II. Hospital Acquired Conditions
• Penalties (1%) on hospitals in the top 25% for the following HACs
(among others)
• CENTRAL VENOUS CATHETER BLOODSTREAM INFECTIONS
• Pressure ulcer rate
• Postop. hip fracture rate
• Postop. sepsis rate
• Postop. pulmonary embolism or DVT
• Catheter-associated urinary tract infection (CAUTI)
• C.difficile/MRSA/SSIs of colon, abdomen coming in ‘16/’17*
*The Advisory Board Company, Healthcare Industry Committee. Hospital-Acquired Condition Reduction Program. C-Suite Cheat Series. August 2013. Accessed 2/21/16.
The Affordable Care Act
Hospital Acquired Condition (HAC) Program
Domain 1(AHRQ Measure)
AHRQ Patient Safety
Indicators PSI-90 Composite
This measure consists of:PSI-3: pressure ulcer
PSI-6: iatrogenic pneumothorax
PSI-7: central venous catheter-related
blood stream infection rate
PSI-8: hip fracture rate
PSI-12: postoperative PE/DVT rate
PSI-13: sepsis rate
PSI-14: wound dehiscence rate
PSI-15: accidental puncture
Weighted 25%
Domain 2(CDC Measure)
Weighted 75%
2015 (measures):CLABSI
CAUTI
2016Surgical Site Infection (Colon Surgery
and Abdominal Hysterectomy)
2017 (2 additional measures):MRSA
C Diff
Performance Period July 1, 2012 – June 30, 2014 Performance Period January 1, 2013 – December 31, 2014
100%
Association of American Medical Colleges presentation. https://s3.amazonnaws.com/public-inspection, federalregister.gov/2013-18956. Accessed 2/20/16.
www.stratishealth.org/documents/HAC_fact_sheet.pdf. Accessed 2/20/16
The ACA
• Changes to CMS
III. Value Based Purchasing (VBP)
• The Name…DOES NOT SAY IT ALL
• Penalties- Up to 2%
• Incentives- Up to 2%
• Budget Neutral for CMS- Hospitals pay on the front end and then
either receive the $$ back, lose the $$, or receive a bonus $$
based upon a Total Performance Score (TPS)*
* http://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/hospital-value-based-
purchasing/index.html?redirect=/hospital-value-based-purchasing/. Accessed 2/20/16
The ACA• Value Based Purchasing
Improvement (self)
Hospitals will be assessed on how much their current
performance changes from their own baseline period
performance
Achievement (others)
Hospitals measured based on how much their current
performance differs from all other hospitals’ baseline
period performance
Total
Performance
Score (TPS)vs
vs
*http://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/hospital-value-based-purchasing/index.html?redirect=/hospital-value-based-
purchasing/. Accessed 2/21/16
The ACA
• Changes to CMS
IV. Value Based Purchasing (VBP)
• Domains/Scoring (‘13) 2017
• Clinical Process- 70% 5%
• Patient Satisfaction- 30% 25%
• Outcomes -0% 25%
• Safety-CLABSI- 0% 20%
• Efficiency-0% 25%*
*http://www.stratishealth.org/documents/FY2017-VBP-fact-sheet.pdf. Accessed 2/19/16
*https://www.cms.gov/Newsroom/MediaReleaseDatabase/Fact-sheets-items/2015-10-26.html Accessed 2/19/16
Percent of CMS Dollars at Stake by FY
2017
Value Based
Purchasing+/
-2%
Readmission
Reduction
Program
3%
Healthcare Acquired
Condition Program
1%plus any
deductions
under the
deficit
reduction act
and other
regulations*
*The Advisory Board Company, Healthcare Industry Committee, Hospital Value-Based Purchasing. C-Suite Cheat Sheet Series. August 2013.-accessed 2/20/16
**The Advisory Board Company, Healthcare Industry Committee, Hospital Readmissions Reduction Program. C- Suite Cheat Sheet Series. August 2013.- accessed 2/20/16
***The Advisory Board Company, Healthcare Industry Committee, Hospital-Acquired Condition Reduction Program. C-Suite Cheat Sheet Series. August 2013. Accessed
2/20/16
The ACA
• So what does 6% amount to anyway???
• Readmissions- $161,240 (average penalty ‘15)
• VBP- $91,873 (average penalty ‘15)
• HACs- $541,896 (average penalty ’15)
• Total = $795,009 (average penalty ‘15)
• But if you were a poor performer the total could be as high as
$8,570,333 !!!!!!!!!!(2015)*
*https://www.ahd.com/state.html. Accessed 2/21/16
The Advisory Board Pay for Performance File-https://www.advisory.com/research/health-care-industry-committee/members/resources/2014/p4p-impact-file.
Accessed 2/21/16
The ACA• More Changes to CMS
• Hospital Inpatient Quality Reporting Program
• Financial incentive (up to 2%) for reporting quality of services so as to provide consumers with data to make more informed decisions re care (Hospital Compare)*
• HAC Reduction Program results available on Hospital Compare
• Includes HAIs- CLABSI, CAUTI, SSIs, MRSA, C.diff as well as other adverse events**
• Uses CDC NHSN definitions and provides hospitals with tools to perform self-assessments
• As of 1/1/15 CLABSI/CAUTI reporting includes ALL medical and surgical beds-not JUST ICUs.
*https://www/cms/gov/medicare/quality-initiatives-patient-assessment-instruments/hospitalqualityinits/hospitalrhqdapu.html. Accessed 2/18/16
** http://www.qualityreportingcenter.com/wp-content/uploads/2015/01/IQR_FY-2016-Reference-Checklist.pdf. Accessed 2/18/16
The ACA
• Health Information Technology for Economic and Clinical
Health (HITECH)-2009
• HITECH is a separate act with funding to enhance the widespread
adoption of electronic health record (EHR) usage*
• Adoption will assist in facilitating compliance with regulatory/data
reporting requirements for adverse events
• Advantages but many risks…
*https://www.healthit.gov/policy-researchers-implementers/health-it-legislation. Accessed 2.22.16
• CMS readmission
penalties3
• Non payment of
Healthcare Acquired
Conditions (HACs)1
• Value-based
purchasing2
• Reportable quality
metrics 2,3,4
• Measured patient
outcomes 2,4
• Patient satisfaction
reporting 2,4
Affordable Care
Act
Regulatory
Requirements
Provider Opportunities
in Changing Landscape
• Reduce Readmissions
• Reduce HAIs
• Improve Patient Satisfaction
• Improve Patient Outcomes
• Use Evidence Based Medicine/Practice
1 – Medicare Program: Changes to the Hospital Inpatient Prospective Payment Systems and Fiscal Year 2009 Rates; Payments for Graduate Medical Education in Certain Emergency Situations; Changes to Disclosure of Physician Ownership
in Hospitals and Physician Self-Referral Rules; Updates to the Long-Term Care Prospective Payment System; Updates to Prospective Payment System; Updates to Certain IPPS-Excluded Hospitals; and Collection of Information Regarding
Financial Relationship Between Hospitals; Final Rule, Federal Register, Volume 73, Number 161, Tuesday, August, 19, 2008. Accessed October 7, 2014
2 – Medicare Program: Hospital Inpatient Value-Based Purchasing Program, Federal Register, Volume 76, Number 88, Friday, May 6, 2011. Accessed October 7, 2014
3 - Medicare Program; Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals and the Long-Term Care Hospital Prospective Payment System and FY2012 Rates; Hospitals’ FTE Resident Caps for Graduate Medical
Education Payment, Federal Register, Volume 76, Number 160, Thursday, August 18, 2011. Accessed October 7, 2014
4 – Medicare Program; Medicare Shared Savings Program: Accountable Care Organizations, Federal Register, Volume 76, Number 212, Wednesday, November, 2, 2011. Accessed October 7, 2014
5 - https://innovation.cms.gov/initiatives/bundled-payments/ Accessed 11/5/15
Goals
More Problems…
Non-clinicians who
know nothing about
infection prevention
have assumed that
all infections must be
preventable and are
somehow the result
of a lapse in patient
care.
“The patient in the next bed is highly
infectious. Thank God for these curtains.”
More Problems…
• Are these preventable HAI sources?
• Overpopulation of hospitals
• Multi-drug resistance
• Visitor hygiene/illnesses
• Patients own immune system condition
• Physical proximity of patients
• Increasingly invasive procedures
• Use of antibiotics
• Endogenous infections
• Multiplicity of HAI origins today often makes it difficult to identify precise HAI source!
More Problems…
Contaminated environment –source of many pathogens “facilities
are dirty” BUT
Evidence lacking – difficult to precisely link infection with exact
environmental source and transmission event ..however
Data on Outbreaks – Successful interruption after interventions
eliminating potential environmental sources
The Problem of
HAI Sources
More Problems…
NHSN HAI Definitions
More Problems…
Healthcare-associated Infection
(HAI)
Must be contracted in healthcare
setting*
Must not be present on admission
(POA)*
POA-2 days prior/2 days
after…*OR REBUTTABLE
PRESUMPTION?
*http://www.cdc.gov/nhsn/pdf/pscmanual/protocol-clarification.pdf. Accessed 2/22/16
More Problems…
BUT…
Many infections are asymptomatic after onset for some time*
Colonization/inflammation are not infections*
Extensions of infections which are POA are not HAI unless there is a
change of pathogens but this is not applicable to SSIs, VAEs*
What about device removal/reinsertion?
No consensus on optimal time point for PVC change or if required at all
CLABSI- just need a central line and the NHSN definition- no need to
prove a source of infection*
PVC infection rate- likely vastly underreported
*http://leg5.state.va.us/reg_agent/frmView.aspx?Viewid=32b11002109~3&typ=40&actno=002109&mime=application/pdf. Accessed 2/20/16
More Problems…
• Does anyone other than Chellie DeVries care about
Peripheral Lines?
• 300 million sold/year
• Up to 90% of patients have a PIV
• Up to 50% failure rate
• PVC infection rate-incidence (up to 2.2%) is low but the numbers
are HUGE
• Are PVC infections less problematic than CLABSIs?
The catheter may be different but the pathogens and pathways are the
SAME*
*Helm R. Klausner K. Klemperer,J. Flint L, Huang E. Accepted but Unacceptable: Peripheral IV Catheter
Failure, The Art and Science of Infusion Nursing;2015:189-203.
Why Should We Care?
• Vascular Clinicians
• Focus of ACA on vascular issues without regard to type/location of
catheter
• Penalties/Incentives for vascular catheter-related events
• Increased scrutiny on reporting, adverse event occurrence,
improvement, patient satisfaction and outcome
• Product selection could have great impact on outcomes
Why Should We Care?
• Vascular Clinicians
• More patients… but not more staff
• More responsibility…but not more $$$
• More documentation…but no more time
• More liability…
• Failure to protect patient from avoidable injury
• Failure to prevent infection
• Failure to monitor and assess clinical status
• Failure to use equipment properly*
*Diehl-Svrjcek B. Dawson B., Duncan L. Infusion Nursing-Aspects of Practice Liability. Journal of Infusion
Nursing, 2007: vol. 30, no 5;274-79.
Why Should We Care?
Providers/Physicians/Nurses
Can always be sued- regardless of merit- and will need to
defend and under strict liability can be liable without fault
and without negligence
Consider having your own Professional Legal Liability
(PLL) insurance:
“Free Nursing Input”- can lead to lawsuits
Good Samaritan Law immunity does not prevent lawsuit filing
Some states permit hospital indemnification for nurse
acts/omissions
Inexpensive
Why Should We Care?
And the big news is that nurses are STRESSED
OUT-Nursing Times
46% worked longer hours than last year
80% reported short staffing at least weekly
73% suffered work related stress-physical, mental problems
37% took more sick leave
74% felt pressure to come to work sick
2x the depression rate of general population
http://www/fiercehealthcare.com/story/survey-nurses-overworked-understaffed-and-stressed/2013-10-01. Accessed 5/5/15
The Legal Stuff
Medical Malpractice occurs when…
http://www.pintas.com/medical-malpractice.html. Accessed 2/2016
The Legal Stuff
Negligence:
Duty- legal duty to exercise
reasonable care
Breach- failure to exercise
reasonable care
Causation- physical harm caused
by the conduct
Damage- physical harm/actual
damages
The Legal Stuff
The Standard of Care…
YOU ARE ALLOWED TO BE WRONG!
YOU ARE ALLOWED TO MAKE MISTAKES!
YOU ARE NOT ALLOWED TO BE NEGLIGENT!!!http://www.west.net/~smith/negligence.htm.
Accessed 2/20/16
The Legal Stuff
• Standard of Care (SOC)
• Experts frequently have different opinions as what constitutes the
SOC
• Nursing has always been based on some sort of evidence
• SOC IS RARELY 100% EVIDENCED BASED but the more
evidence based the stronger the standard
The Legal Stuff
• What is Evidence Based Medicine (EBM) or Evidence
Based Practice (EBP)?
• Problem solving approach to clinical decision making within a
healthcare organization integrating best available scientific and
experiential evidence. (Science & Experience)*
*http://www.hopkinsmedicine.org/gim/research/method/ebm.html. Accessed 2/20/16
The Legal Stuff
• What is the importance of EBM and EBP?
• Will NOT prevent you from getting sued… BUT
• Should improve the quality of care provided and
• Should decrease your chances of litigation*
*http://www.ampirrg.com/articles/Evidence-based_medicine.pdf.
Accessed 2/20/16
The Legal Stuff
• How does PRODUCT SELECTION fit in with EBM and
EBP?
• Utilizing products that are Evidenced Based:
• Proven and tested;
• Should reduce adverse events and improve patient outcomes;
• Should reduce variation across the continuum of care
• Should reduce medical malpractice because using EBM/EBP should
validate meeting the SOC;
• Supported by industry standards; and
• Should improve patient outcomes which WILL REDUCE
COSTS/IMPROVE REIMBURSEMENTS UNDER THE ACA !!!!
The Issue
Are products the
solution to
healthcare
associated
bloodstream
infections?
Joint Commission
National Patient Safety Goal #7
Hospitals implement policies and
practices aimed at reducing the risk
of central line-associated bloodstream
infections and surgical site infections
that meet regulatory requirements
and are aligned with evidence-based
standards
http://www.jointcommission.org/assets/1/6/2015_NPSG_HAP.pdf. Accessed 2/22/16
2011 CRBSI CDC GuidelinesIntended to provide evidence-based
recommendations for preventing
intravascular catheter-related
infections
5 major areas of emphasis:
1. Education of healthcare professionals
2. Use maximal sterile precautions (MSP)
3. Use of > 0.5% CHG skin prep
4. Avoiding routine replacement of CV
catheters
as a strategy to prevent infections
5. Use antiseptic/antibiotic impregnated
catheters and CHG impregnated
sponge dressing
(If rate of infection not decreasing
despite adherence to above 4 strategies)
Targets elimination of CRBSI
from all patient-care areas
• “strongly recommended for
implementation and supported by
some experimental, clinical, or
epidemiologic studies and a strong
theoretical rationale”
• CHG impregnated sponge dressings
are the only form of CHG dressing
recommended in new CDC guidelines
• “No recommendation is made for other
types of chlorhexidine dressings
(Unresolved Issue)”
CHG impregnated sponge
dressings received a Category 1B
recommendation for reducing
the risk of CLABSIs
O’Grady NP, Alexander M, et al. Guidelines for the prevention of intravascular catheter-related infections. Centers for Disease Control and Prevention. MMWR
Recomm Rep 2011 April 1. Accessed 2/20/16
Product Selection“Oh…
They’ve
changed
our product
again”
“We’ve always
used this…”
“…it’s how we’ve
always done it.”
Liability Mitigation
To Make EBP/EBM the SOC- the next time
someone tells you that we’ve changed the product-
tell them- “SHOW ME THE DATA”…
Liability Mitigation
• Products may look alike but BE CAREFUL….
Liability Mitigation
• Vascular Product Selection to meet EBM STANDARD (HACs, VBP):
• Clinical evidence (level I,II,III evidence)-DOES IT WORK???
• Compliance with standards (which ones?)
• Active ingredient (CHG- how much?) and delivery
• Product duration/durability (does it last over time and will it crumble?)
• Infection prevention capability?
• Product Design?
• Cleared indication (for what?)
• Years on the market?/Product success (market share)?
• READ THE LABEL- what does it do and how does it do it (how does it work) and does it meet best practice requirements?
• Patient issues-impact/satisfaction
• Device issues- stability/securement/removal/application
• DOES IT PAY FOR ITSELF (supporting studies)???
Liability Mitigation
• Vascular Product Selection to meet PATIENT STANDARD
(patient satisfaction):
• Which one of these things do I want in my body and why????
Liability Mitigation
• Product Selection-Patient Standard
• Best product
• Least intrusive/pain/adverse effects
• Shortest duration
• Product history/market share
• Economical
Program Summary
• Standard of Care (SOC)- the caution that a reasonable
person in similar circumstances would exercise in
providing care
• To meet the SOC- practice EBM- problem solving
approach integrating both scientific and experiential
evidence
• Practicing EBM is a goal of the ACA because it will
improve patient outcomes which will:
• Reduce Readmissions
• Reduce HACs
• Improve patient satisfaction and
• Improve the bottom line ($$$)
Goals For All Lines
1. Medicare Program: Changes to the Hospital Inpatient Prospective Payment Systems and Fiscal Year 2009 Rates; Payments for Graduate Medical Education in Certain Emergency Situations; Changes to Disclosure of
Physician Ownership in Hospitals and Physician Self-Referral Rules; Updates to the Long-Term Care Prospective Payment System; Updates to Prospective Payment System; Updates to Certain IPPS-Excluded Hospitals;
and Collection of Information Regarding Financial Relationship Between Hospitals; Final Rule, Federal Register, Volume 73, Number 161, Tuesday, August, 19, 2008. Accessed October 7, 2014
2. Medicare Program: Hospital Inpatient Value-Based Purchasing Program, Federal Register, Volume 76, Number 88, Friday, May 6, 2011. Accessed October 7, 2014
3. Medicare Program; Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals and the Long-Term Care Hospital Prospective Payment System and FY2012 Rates; Hospitals’ FTE Resident Caps for Graduate
Medical Education Payment, Federal Register, Volume 76, Number 160, Thursday, August 18, 2011. Accessed October 7, 2014
4. Medicare Program; Medicare Shared Savings Program: Accountable Care Organizations, Federal Register, Volume 76, Number 212, Wednesday, November, 2, 2011. Accessed October 7, 2014
Readmission
Rates
Peripheral IV
Lines
Surgical
Drains
Home
Infusion
Arterial
Lines
Staff Compliance= Kits
CVC Lines &
PICC Lines
Dialysis
Patients
LVADs
SSIs
Provider Opportunities
in Changing Landscape/Goals
• Significantly Reduce Readmissions
• Significantly Reduce HAIs
• Increase Patient Satisfaction
• Improve Patient Outcomes
• Use Evidence-based Medicine/Practice/Protocols
Questions
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