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a LANGE medical book
CURRENT
Diagnosis & Treatment
Pediatrics
TWENTY-FOURTH EDITION
Edited by
William W. Hay, Jr., MD Robin R. Deterding, MD
Professor, Department of Pediatrics Professor, Department of Pediatrics
Section of Neonatology and Chief, Section of Pediatric Pulmonary Medicine
Division of Perinatal Medicine University of Colorado School of Medicine and
University of Colorado School of Medicine Children’s Hospital Colorado
and Children’s Hospital Colorado Medical Director, Breathing Institute Children’s
Hospital Colorado
Myron J. Levin, MD
Professor, Departments of Pediatrics and Medicine Mark J. Abzug, MD
Section of Pediatric Infectious Diseases Professor, Department of Pediatrics
University of Colorado School of Medicine Section of Pediatric Infectious Diseases
and Children’s Hospital Colorado Associate Vice Chair for Academic Affairs,
Department of Pediatrics
University of Colorado School of Medicine and
Children’s Hospital Colorado
New York Chicago San Francisco Athens London Madrid Mexico City Milan
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Contents
Authors xix Esophageal Atresia & Tracheoesophageal
Preface xxix Fistula 48
Selected Highlighted Topics in the Intestinal Obstruction 49
24th Edition of CDT-P xxxi Abdominal Wall Defects 50
Diaphragmatic Hernia 51
1. Advancing the Quality Gastrointestinal Bleeding 51
& Safety of Care 1 Gastroesophageal Reflux 51
Infections in the Newborn Infant 52
Daniel Hyman, MD Bacterial Infections 52
Introduction 1 Fungal Sepsis 55
Current Context 1 Congenital Infections 56
Strategies & Models for Perinatally Acquired Infections 58
Quality Improvement (QI) 4 Hematologic Disorders in the Newborn Infant 59
Principles of Patient Safety Bleeding Disorders 59
(Incident Reporting, Just Culture, Anemia 60
Disclosure, FMEA, RCA, Polycythemia 61
Reliability, Checklists) 7 Renal Disorders in the Newborn Infant 62
Renal Failure 62
2. The Newborn Infant 10 Urinary Tract Anomalies 62
Renal Vein Thrombosis 63
Danielle Smith, MD Neurologic Problems in the Newborn Infant 63
Theresa Grover, MD Seizures 63
Introduction 10 Intracranial Hemorrhage 64
The Neonatal History 10 Metabolic Disorders in the Newborn Infant 65
Assessment of Growth & Gestational Age 10 Hyperglycemia 65
Examination at Birth 12 Hypocalcemia 65
Examination in the Nursery 13 Inborn Errors of Metabolism 66
Care of the Well Neonate 15 Quality Assessment & Improvement
Feeding the Well Neonate 15 in the Newborn Nursery & NICU 66
Early Discharge of the Newborn Infant 17
Hearing Screening 18 3. Child Development & Behavior 67
Common Problems in the Term Newborn 18
Neonatal Jaundice 18 Edward Goldson, MD
Hypoglycemia 25 Ann Reynolds, MD
Respiratory Distress in the Term Introduction 67
Newborn Infant 26 Normal Development 67
Heart Murmurs 28 The First 2 Years 67
Birth Trauma 28 Ages 2–4 Years 73
Infants of Mothers Who Abuse Drugs 29 Early School Years: Ages 5–7 Years 74
Multiple Births 31 Middle Childhood: Ages 7–11 Years 74
Neonatal Intensive Care 32 Behavioral & Developmental Variations 74
Perinatal Resuscitation 32 Normality & Temperament 74
The Preterm Infant 36 Enuresis & Encopresis 75
The Late Preterm Infant 45 Enuresis 75
Cardiac Problems in the Newborn Infant 46 Encopresis 76
Structural Heart Disease 46 Common Developmental Concerns 77
Persistent Pulmonary Hypertension 47 Colic 77
Arrhythmias 48 Feeding Disorders in Infants &
Gastrointestinal & Abdominal Surgical Young Children 79
Conditions in the Newborn Infant 48 Sleep Disorders 80
iii
Disorders of the Nasolacrimal System 437 17. Oral Medicine & Dentistry 466
Nasolacrimal Duct Obstruction 437
Congenital Dacryocystocele 438 Ulrich Klein, DMD, DDS, MS
Dacryocystitis 438 Roopa P. Gandhi, BDS, MSD
Diseases of the Conjunctiva 439 Camille V. Gannam, DMD, MS
Ophthalmia Neonatorum 439 Issues in Pediatric Oral Health 466
Bacterial Conjunctivitis 440 Oral Examination of Children 467
Viral Conjunctivitis 440 Eruption of the Teeth 469
Allergic Conjunctivitis 441 Dental Caries 471
Mucocutaneous Diseases 442 Periodontal Disease 473
Disorders of the Iris 443 Dental Emergencies 474
Iris Coloboma 443 Special Patient Populations 475
Aniridia 444 Orthodontic Referral 477
Albinism 444
Miscellaneous Iris Conditions 445 18. Ear, Nose, & Throat 478
Glaucoma 445
Patricia J. Yoon, MD
Uveitis 445
Melissa A. Scholes, MD
Anterior Uveitis/Iridocyclitis/Iritis 446
Norman R. Friedman, MD
Posterior Uveitis 446
Intermediate Uveitis 447 The Ear 478
Disorders of the Cornea 448 Infections of the Ear 478
Cloudy Cornea 448 Acute Trauma to the Middle Ear 488
Viral Keratitis 448 Ear Canal Foreign Body &
Corneal Ulcers 449 Cerumen Impaction 488
Disorders of the Lens 450 Auricular Hematoma 489
Cataracts 450 Congenital Ear Malformations 489
Dislocated Lenses/Ectopia Lentis 450 Identification & Management of
Disorders of the Retina 451 Hearing Loss 489
Retinal Hemorrhages in the Newborn 451 The Nose & Paranasal Sinuses 492
Retinopathy of Prematurity 451 Acute Viral Rhinitis 492
Retinoblastoma 452 Rhinosinusitis 493
Retinal Detachment 453 Choanal Atresia 495
Diabetic Retinopathy 454 Recurrent Rhinitis 495
Diseases of the Optic Nerve 454 Epistaxis 496
Optic Neuropathy 454 Nasal Infection 497
Optic Nerve Hypoplasia 455 Nasal Trauma 497
Papilledema 456 Foreign Bodies in the Nose 497
Optic Neuritis 457 The Throat & Oral Cavity 497
Optic Atrophy 458 Acute Stomatitis 497
Diseases of the Orbit 458 Pharyngitis 498
Periorbital & Orbital Cellulitis 458 Peritonsillar Cellulitis or Abscess (Quinsy) 501
Craniofacial Anomalies 459 Retropharyngeal Abscess 501
Orbital Tumors 459 Ludwig Angina 501
Nystagmus 460 Acute Cervical Adenitis 502
Amblyopia 461 Snoring, Mouth Breathing, & Upper Airway
Strabismus 462 Obstruction 503
Unexplained Decreased Vision Tonsillectomy & Adenoidectomy 505
in Infants & Children 464 Disorders of the Lips 506
Learning Disabilities & Dyslexia 464 Disorders of the Tongue 506
Halitosis 506
Salivary Gland Disorders 507
Congenital Oral Malformations 507
xix
Shikha S. Sundaram, MD, MSCI Johan L. K. Van Hove, MD, PhD, MBA
Associate Professor, Department of Pediatrics, Section of Professor, Department of Pediatrics, Head, Section of Clinical
Pediatric Gastroenterology, Hepatology and Nutrition, Genetics and Metabolism, University of Colorado School of
University of Colorado School of Medicine and Children’s Medicine and Children’s Hospital Colorado
Hospital Colorado Chapter 36: Inborn Errors of Metabolism
Chapter 22: Liver & Pancreas
Armando Vidal, MD
Alex Tagawa, BS Associate Professor, Department of Orthopedics—Sports
Research Assistant, Center for Gait and Movement Analysis, Medicine Program, University of Colorado School of
Department of Pediatric Orthopedics, University Medicine and Children’s Hospital Colorado
of Colorado School of Medicine and Children’s Hospital Chapter 27: Sports Medicine
Colorado
Chapter 26: Orthopedics
INTENDED AUDIENCE
Like all Lange medical books, CDTP provides a concise yet comprehensive source of current information. Students will find
CDTP an authoritative introduction to pediatrics and an excellent source for reference and review. CDTP provides excellent
coverage of The Council on Medical Student Education in Pediatrics (COMSEP) curriculum used in pediatric clerkships.
Residents in pediatrics (and other specialties) will appreciate the detailed descriptions of diseases as well as diagnostic and
therapeutic procedures. Pediatricians, family practitioners, nurses, nurse practitioners, physician assistants, and other health
care providers who work with infants, children, and adolescents will find CDTP a useful reference on management aspects of
pediatric medicine.
COVERAGE
Forty-six chapters cover a wide range of topics, including neonatal medicine, child development and behavior, emergency and
critical care medicine, and diagnosis and treatment of specific disorders according to major problems, etiologies, and organ
systems. A wealth of tables and figures provides quick access to important information, such as acute and critical care pro-
cedures in the delivery room, the office, the emergency room, and the critical care unit; anti-infective agents; drug dosages;
immunization schedules; differential diagnosis; and developmental disorders.
xxix
CHAPTER REVISIONS
The 19 chapters that have been extensively revised, with new authors added in several cases, reflect the substantially updated
material in each of their areas of pediatric medicine. Especially important are updates to the chapters on immunizations, endo-
crinology, neurologic and muscular disorders, and adolescence. The chapter on HIV includes current guidelines for prevention
and treatment of HIV and updates information on the new antiretroviral therapies that have become available. The chapter on
immunizations contains the most recently published recommendations, discusses the contraindications and precautions rel-
evant to special populations, and includes the new vaccines licensed since the last edition of this book. Chapters on adolescence,
skin, immunodeficiency, inborn errors of metabolism, and neoplastic disease are markedly updated with the latest information.
All laboratory tables in Chapter 46 Pediatric Laboratory Medicine and Reference Ranges that includes reference ranges and
reference intervals have been updated. All other chapters are substantially revised and references have been updated. Twenty-
six new authors have contributed to these revisions.
ACKNOWLEDGMENTS
The editors would like to thank Bonnie Savone for her expert assistance in managing the flow of manuscripts and materials
among the chapter authors, editors, and publishers. Her attention to detail was enormously helpful. The editors also would like
to thank Tia Brayman at Children’s Hospital Colorado who produced the cover photographs.
xxxi
1
Advancing the Quality &
Safety of Care
Daniel Hyman, MD
INTRODUCTION and, indeed throughout the world, have accelerated their indi-
vidual and collective involvement in analyzing and improving
Hippocrates’ famous dictum primum non nocere 2500 years care. In the United States, numerous governmental agencies,
ago may have been the earliest reflection of the importance large employer groups, health insurance plans, consumers/
of patient safety, but the Institute of Medicine’s (IOM) 1999 patients, health care providers, and delivery systems are
landmark report To Err Is Human truly galvanized the cur- among the key constituencies calling for and working toward
rent focus on eliminating preventable harm from health better and safer care at lower cost. Similar efforts are occur-
care. Its most quoted statistic, that between 44,000 and ring internationally. Indeed, the concept of the Triple Aim
98,000 Americans die every year because of medical error, has been widely accepted as an organizing framework for con-
was based upon studies of hospital mortality in Colorado, sidering the country’s overall health care improvement goals.
Utah, and New York and extrapolated to an annual estimate
for the country. The IOM followed up this report with a Committee on Quality Health Care in America, Institute of Medi-
second publication, Crossing the Quality Chasm, in which cine: Crossing the Quality Chasm: a New Health System for the
they said, “Health care today harms too frequently, and 21st Century. Washington, DC: National Academy Press, 2001.
routinely fails to deliver its potential benefits…. Between the Kohn L, Corrigan JM: To Err Is Human: Building a Safer Health
health care we have and the care we could have lies not just a System. Washington, DC: National Academy Press, 2000.
gap, but a chasm.” These two reports have served as central
elements in an advocacy movement that has engaged stake-
holders across the continuum of our health care delivery
CURRENT CONTEXT
system and changed the nature of how we think about the The health care industry is in a period of transformation
quality and safety of the care we provide, and receive. being driven by at least four converging factors: (1) the rec-
In Crossing the Quality Chasm, the IOM included a ognition of serious gaps in the safety and quality of care we
simple but elegant definition of the word “Quality” as it provide (and receive), (2) the unsustainable increases in the
applies to health care. They defined six domains of health cost of care as a percent of the national economy, (3) the
care quality: (1) SAFE—free from preventable harm, (2) aging of the population, and (4) the emerging role of health
EFFECTIVE—optimal clinical outcomes; doing what we care information technology as a potential tool to improve
should do, not what we should not do according to the care. These are impacting health care organizations as well as
evidence, (3) EFFICIENT—without waste of resources— individual practitioners in numerous ways that can also be
human, financial, supplies/equipment, (4) TIMELY—without traced to expectations regarding transparency and increas-
unnecessary delay, (5) PATIENT/FAMILY CENTERED— ing accountability for results. As depicted in Figure 1–1,
according to the wishes and values of patients and their the Quadruple Aim (advancing the original concept of the
families, and (6) EQUITABLE—eliminating disparities in Triple Aim) includes the simultaneous goals of achieving
outcomes between patients of different race, gender, and better care (outcomes/experience) for individual patients and
socioeconomic status. families, better health status for the population, lower overall
In the years since these two reports were published, the cost of care, and enhancing the experience of the health care
multiple stakeholders have been concerned about the effec- workforce. Practitioners and trainees (and health care workers
tiveness, safety, and cost of health care in the United States in general) must adapt to a new set of priorities that focus
*IHI Quadruple Aim population. The agency has also enabled and advocated
for greater transparency of results and makes available
on its website comparative measures of performance for
its Medicare population. CMS is also increasingly utiliz-
ing its standards under which hospitals and other health
Improved care provider organizations are licensed to provide care
*Better clinician as tools to ensure greater compliance with these regula-
outcomes experience tions. It has instituted a Hospital-Acquired Condition
Reduction program (https://www.cms.gov/medicare/
medicare-fee-for-service-payment/acuteinpatientpps/
HAC-reduction-program.html) which targets a range
of conditions, with payment reductions from Medicare
*Improved based upon rates of occurrence. It is worth noting that
*Lower
costs
patient CMS is able to generate comparative national data only
experience for its Medicare population because it, unlike Medicaid,
is a single federal program with a single financial data-
base. Because the Medicaid program functions as 51
state/federal partnership arrangements, patient expe-
▲▲Figure 1–1.
rience and costs are captured in 51 separate state-based
Quadruple aim. program databases. This segmentation has limited the
development of national measures for pediatric care
attention on new goals to extend our historic focus on the in both inpatient and ambulatory settings. Similarly,
doctor/patient relationship and autonophysician decision while the reporting of HACs is uniform across the
making. Instead, our system’s new imperatives are evidence- United States for Medicare patients, in the Medicaid
based medicine, advancing safety, and reducing unnecessary population it varies by individual state and payment
expense. There is recognition that we need to care for our implications are both limited and state based.
workforce and understand their challenges if we are to achieve 2. National Quality Forum—www.qualityforum.org/Home
our patient oriented goals. Staff must be safe, both physically National Quality Forum (NQF) is a private, not-for-
and psychologically, and their resiliency and stress is increas- profit organization whose members include consumer
ingly a focus of health care systems around the country. advocacy groups, health care providers, accrediting
The impact of health care quality improvement will bodies, employers and other purchasers of care, and
increasingly influence clinical practice and the delivery of research organizations. Its mission is to promote
pediatric care in the future. This chapter provides a sum- improvement in the quality of American health care
mary of some of the central elements of health care quality primarily through defining priorities for improvement,
improvement and patient safety, and offers resources for the approving consensus standards and metrics for perfor-
reader to obtain additional information and understanding mance reporting, and through educational efforts. The
about these topics. NQF, for example, has endorsed a list of 29 “serious
To understand the external influences driving many of reportable events” in health care that include events
these changes, there are at least six key national organiza- related to surgical or invasive procedures, products or
tions central to the transitions occurring: device failures, patient protection, care management,
1. Center for Medicare and Medicaid Services (Depart- environmental issues, radiologic events, and potential
ment of Health and Human Services)—www.cms.gov criminal events. This list and the CMS list of HACs
Center for Medicare and Medicaid Services (CMS) are both being used by insurers to reduce payment to
oversees federally funded health care programs of the hospitals/providers as well as to require reporting to
United States, including Medicare, Medicaid, and other state agencies for public review. In 2012, NQF released
related programs. CMS and the Veterans Affairs a set of 44 measures for the quality of pediatric care,
Divisions together now provide funding for more than largely representing outpatient preventive services and
1 trillion of the total $3.2 trillion the United States management of chronic conditions, and population-
spends annually on health care expense. CMS is increas- based measures applicable to health plans, for example,
ingly promoting payment mechanisms that withhold immunization rates and frequency of well-child care.
payment for the costs of preventable complications of 3. Leapfrog—www.leapfroggroup.org
care and giving incentives to providers for achieving bet- Leapfrog is a group of large employers who seek to
ter outcomes for their patients, primarily in its Medicare use their purchasing power to influence the health
care community to achieve big “leaps” in health care organizations, including hospitals, nursing homes, and
safety and quality. It promotes transparency and issues other health care provider entities in the United States
public reports of how well individual hospitals meet as well as internationally. Its mission is to continuously
their recommended standards, including computerized improve the quality of care through evaluation, educa-
physician-order entry, ICU staffing models, and rates tion, and enforcement of regulatory standards. Since
of hospital-acquired infections. There is some evi- 2003, JC has annually adopted a set of National Patient
dence that meeting these standards is associated with Safety Goals designed to help advance the safety of care
improved hospital quality and/or mortality outcomes. provided in all health care settings. Examples include
4. Agency for Healthcare Research and Quality—www. the use of two patient identifiers to reduce the risk of
ahrq.gov care being provided to an unintended patient; the use
Agency for Healthcare Research and Quality (AHRQ) of time-outs and a universal protocol to improve surgi-
is currently one of 11 agencies within the US Department cal safety and reduce the risk of wrong site procedures;
of Health and Human Services, although this is one adherence to hand hygiene recommendations to reduce
of many things subject to change with the Trump the risk of spreading hospital-acquired infections, to
administration’s 2018 budget proposal. AHRQ’s primary name just a few. These goals often become regulatory
mission has been to support health services research standards with time and widespread adoption. Failure
initiatives that seek to improve the quality of health care to meet these standards can result in actions against
in the United States. Its activities extend well beyond the licensure of the health care provider, or more com-
the support of research and now include the develop- monly, requires corrective action plans, measurement
ment of measurements of quality and patient safety, to demonstrate improvement, and resurveying depend-
reports on disparities in performance, measures of ing upon the severity of findings. The JC publishes
patient safety culture in organizations, and promotion a monthly journal on quality and safety, available at
of tools to improve care among others. AHRQ also con- http://store.jcrinc.com/the-joint-commission-journal-
venes expert panels to assess national efforts to advance on-quality-and-patient-safety/.
quality and patient safety and to recommend strategies
Finally, ongoing governmental impacts on quality and
to accelerate progress.
safety will be subject to modifications in the US government’s
5. Specialty Society Boards anticipated repeal, replacement or changes in the Patient
Specialty Society Boards, for example, American Board Protection and Affordable Care Act (PPACA) enacted by
of Pediatrics (ABP). The ABP, along with other spe- the US government in 2010. This federal health care leg-
cialty certification organizations, has responded to the islation sought to provide near-universal access to health
call for greater accountability to consumers by enhanc- care through discounted health care exchanges that sup-
ing its maintenance of certification programs (MOC). plemented the existing, largely employer-based system.
All trainees, and an increasing proportion of active Changes in payment mechanisms for health care will con-
practitioners, are now subject to the requirements of tinue irrespective of what happens to the PPACA, and cur-
the MOC program, including participation in qual- rent and future providers’ practices will be economically,
ity improvement activities in the diplomate’s clinical structurally, and functionally impacted by these emerging
practice. The Board’s mission is focused on assuring trends. Furthermore, changes in the funding and structure
the public that certificate holders have been trained of the US health care system may ultimately also result in
according to their standards and also meet continuous changes in other countries. Many countries have single-
evaluation requirements in six areas of core compe- payer systems for providing health care to their citizens and
tency: patient care, medical knowledge, practice-based often are leaders in defining new strategies for health care
learning and improvement, interpersonal and com- improvement.
munication skills, professionalism, and systems-based
practice. These are the same competencies as required
Agency for Healthcare Research and Quality. www.ahrq.gov.
of residents in training programs as certified by the Accessed March 23, 2017.
Accreditation Council on Graduate Medical Educa- American Board of Pediatrics. https://www.abp.org. Accessed
tion. Providers need not only to be familiar with the March 23, 2017.
principles of quality improvement and patient safety, Berwick D, Nolan T, Whittington J: The triple aim: care,
but also must demonstrate having implemented qual- health, and cost. Health Aff (Millwood) 2008;27(3):759–769.
ity improvement efforts within their practice settings. doi:10.1377/hlthaff.27.3.759 [PMID: 18474969].
Center for Medicare and Medicaid Services: Triple Aim.
6. The Joint Commission—www.jointcommission.org Center for Medicare and Medicaid Services. www.cms.gov.
The Joint Commission (JC) is a private, nonprofit Accessed March 23, 2017.
agency that is licensed to accredit health care provider
for patients with asthma seen at E Street Pediatrics by 25% the treatment plan into action as a part of the process of
by December 31, 2017,” whereas this next statement does care, and that the health status or outcome measure will be
not, “We will improve the care for patients with asthma by improved by fully improving the measured processes of care,
appropriately prescribing indicated medications and better including patient adherence to the treatment plan.
educating families in their use.” Measures are essential elements of any improvement
The first example provides a specific measurable goal, a work. It is a good idea to choose a manageable (4–6) number
time frame, and clarity with respect to who the patients are. of measures, all of which can be obtained with limited or no
A 25% reduction in ED/inpatient asthma visits will require a extra effort, and with a mix of outcome, process, and balanc-
change in the system for asthma care delivery for the entire ing measures. Ideally, the best process measures are those
population of children with asthma; that extent of level of that are directly linked to the outcome goal. The hypoth-
improvement is a stretch, but it is much more achievable esis in this specific example would be that assessing asthma
than a goal would be if it was set to “eliminate” such encoun- severity and appropriately using controller medications and
ters. The second example is unclear in terms of the measure action plans would all contribute to reducing the number
for improvement, the time frame for the goal to be met, and or frequency of missed school days and the need for ED/
even the population in question. The statement provides hospital utilization.
some sense of processes that could be utilized to improve It is important to note that measurement in the setting
asthma care but is missing needed specificity. of an improvement project is different from measurement in
a research study. Improvement projects require “just enough”
MEASURES data to guide the team’s continuing efforts. Often, the result
seen in a sequence of 10 patients is enough to tell you whether a
Specific measures provide a means to assess whether or not particular system is functioning consistently or not. For exam-
the improvement effort is on track. Three types of measures ple, considering the first process measure in Table 1–1, if in the
are useful. Outcome measures answer questions concerning last 10 patients seen with asthma, only two had their asthma
the health care impact for the patients, such as how has their severity documented, how many more charts need be checked
health status changed? Process measures are related to the to conclude that the system is not functioning as intended and
health care delivery system itself. They answer questions that changes are needed? Other measures may require larger
about how the system is performing. Balancing measures sample sizes, especially when assessing the impact of care
seek to identify potential unintended consequences that are changes on a population of patients with a particular condi-
related to the improvement effort being undertaken. Exam- tion. See Randolph’s excellent summary for a fuller description
ples are helpful to contextualize these conceptual definitions. of measurement for improvement.
Table 1–1 reflects some examples of types of measures
that might be employed in an asthma QI initiative.
One might argue that adherence to a treatment plan
CHANGES & IDEAS
(third process measure) is an outcome of the work of Once the team’s aim is established and the measures are
the practice/practitioner prescribing the medication. It is selected, the third component of the MFI draws from indus-
more consistent, however, to consider the translation of trial engineering and focuses on what changes in the system
Percent of children with asthma in the Proportion of children with an asthma Average difference in the time between
practice seen in the ED or hospitalized severity assessment in their medical record the last office patient’s scheduled
for asthma in the past 6 months in the past year appointment time and the actual office
close time
Percent of children with persistent asthma Percent of children with persistent asthma, of any Staff satisfaction with their job
in the practice with fewer than five missed severity, prescribed a controller medication at their
school days due to asthma in the past year most recent visit
Percent of children prescribed a controller
medication who report taking their medicine
Percent of children in a practice asthma registry
provided with a complete asthma action plan in the
past 12 months
“SIX SIGMA” way things are done now, and then implementing planned
changes to see how they impact the outputs or outcomes.
A third quality-improvement methodology also arose in the For additional information on Lean and Six Sigma, see
manufacturing industry. Motorola is generally credited with www.isixsigma.com or www.asq.org/sixsigma.
promoting Six Sigma as a management strategy designed
to reduce the variability in its processes and thereby reduc-
ing the number of defects in its outputs. Organizations Pande P, Holpp L: What Is Six Sigma? New York, NY: McGraw-
adopting Six Sigma as an improvement strategy utilize mea- Hill; 2002.
surement-based strategies that focus on process improve-
ment and variation reduction to eliminate defects in their
work and to reduce cycle times, thereby increasing profit-
PRINCIPLES OF PATIENT SAFETY (INCIDENT
ability and enhancing customer satisfaction. Sigma is the sta-
REPORTING, JUST CULTURE, DISCLOSURE,
tistical measure of standard deviation and Motorola adopted
FMEA, RCA, RELIABILITY, CHECKLISTS)
Six Sigma as a performance indicator, promoting consistency Safe patient care avoids preventable harm; it is care that
of processes in order to have fewer than 3.4 defects per million does not cause harm as it seeks to cure. The list of adverse
opportunities. This performance goal has since become the events that are considered to be preventable is evolving. As
common descriptor for this approach to improvement both mentioned earlier, both CMS and NQF have endorsed lists
in manufacturing and in service industries, including health of various complications of care as being “never events” or
care. Similar to Lean, the translation of business manufac- “serious reportable events” for which providers are often
turing strategies into health care has various challenges, but now not reimbursed, and which are increasingly reportable
there are many processes that repeatedly occur in health to the public through various state transparency programs.
care that can be routinized and made more consistent. Many A national network of Children’s Hospitals has been
health care processes fail far more frequently than 3.4 times active since 2012, collaborating on a shared aim of eliminat-
per million opportunities. Consider pharmacy dispensing ing serious harm in their now more than 110 organizations.
errors, medication ordering or administration errors, and Initially funded as a Hospital Engagement Network by the
patient-scheduling errors, just to name a few. These are a Center for Medicare and Medicaid Innovation program,
few of many examples of processes that could potentially Children’s Hospitals Solutions for Patient Safety merges
benefit from the kind of rigorous analysis that is integral to approaches to achieving reliability in evidence-based pre-
the Six-Sigma approach. vention practices (“bundles”) with safety practices at both
In a typical Six-Sigma structured improvement project, staff and leadership levels to reducing serious safety events
there are five phases generally referred to as DMAIC: (1) (SSEs) and HACs in general. Numerous hospitals have
Define (what is the problem, what is the goal?), (2) Measure demonstrated dramatic reductions in the occurrence rates
(quantify the problem and improvement opportunity), (3) of both HACs and SSEs with the following interventions:
Analyze (use of observations and data to identify causes), (4) (1) implementation of structured processes to improve
Improve (implementation of solutions based on data analy- consistency of prevention processes, (2) education and rein-
sis), and finally, (5) Control (sustainable change). forcement of principles of patient safety culture designed to
One of the central aspects of Six Sigma as an improve- improve communication and reduce error, and (3) effective,
ment strategy is its defined focus on understanding the structured cause analyses after SSEs.
reasons for defects in any process. By understanding these Irrespective of one’s views about whether various compli-
drivers, it is then possible to revise the approach to either cations are entirely preventable at the current state of science
the manufacturing process or the service functions in order or not, these approaches reflect a changing paradigm that is
to reduce these errors and failures. impacting many aspects of health care delivery. Transpar-
“Lean-Six Sigma” is a newer entity that draws from both ency of results is increasingly expected. Perspectives and
methodologies in order to simplify the improvement work data on how these kinds of efforts are impacting actual
where possible, but retain the rigorous statistical method improvement in outcomes are mixed.
that is a hallmark of Six-Sigma projects. Lean focuses on Given these trends, health care providers need to have
where time is lost in any process and can identify opportu- robust systems for measuring and improving the safety of
nities to eliminate steps or reduce time. Six Sigma aims to care provided to patients. The methods for improving qual-
reduce or eliminate defects in the process, thereby resulting ity reviewed earlier are frequently used to reduce harm, just
in a higher quality product through a more efficient and as they can be used to improve effectiveness or efficiency.
lower cost process. For example, hospitals attempting to reduce infections
Regardless of the method used, improvement happens have successfully used these types of process improvement
because an organization, team, or individual sets a goal to approaches to improve antibiotic use prior to surgical pro-
improve a current process through systematic analysis of the cedures or to improve hand hygiene practices.
Common patient safety tools are summarized here. Failure modes and effects analyses (FMEA): An FMEA is a
Incident-reporting systems: Efforts to advance safety in any systematic methodology used to proactively identify ways
organization require a clear understanding of the kinds of in which any process might fail, and then to prioritize
harm occurring within that organization, as well as the among strategies for reducing the risk or impact of identi-
kinds of “near-misses” that are occurring. These reporting fied potential failures. In conducting an FMEA, which all
systems can range from a simple paper reporting form to hospitals are required to do annually, a team will carefully
a “telephone hot-line” to a computerized database that describe and analyze each step in a particular process,
is available to staff (and potentially patients) within the consider what and how anything might go wrong, why
organization. Events are traditionally graded according to it would happen and what the impact would be of such
the severity of harm that resulted from the incident. One failures. Like Lean and Six Sigma, the FMEA has been
example is the NCC MERP Index, which grades events adopted into health care from its origins in military and
from A (potential to cause harm) to I (resulting in patient industrial settings. The FMEA is an effective method for
death). Errors that are recognized represent only a frac- identifying strategies to reduce risks in health care set-
tion of the actual errors and near-misses that are present tings, thereby protecting patients if interventions are put
in the system. Incident-reporting systems depend upon into place as a result of the analysis. A tool to use in con-
people recognizing the error or near-miss, being comfort- ducting an FMEA is available from the IHI (http://www.
able reporting it, knowing how and when to report, and ihi.org/knowledge/Pages/Tools/FailureModesandEffects-
then actually doing so. It is no surprise therefore that esti- AnalysisTool.aspx). Their site includes additional infor-
mates for how frequently incidents that could or should mation and resources about the FMEA process.
be reported into incident-reporting systems range from Root-cause analyses (RCA) (postevent reviews): As con-
1.5% to 30% depending on the type of adverse or near- trasted with the proactive FMEA process, an RCA is
miss event. “Trigger tools” (either manual chart reviews a retrospective analysis of an adverse occurrence (or
for indications of adverse events, or automated reports near-miss) that has already happened. It too is a sys-
from electronic medical records) are increasingly being tematic process that in this case allows a team to reach
used to increase the recognition of episodes of harm in an understanding of why certain things occurred, what
health care settings. systems factors and human factors contributed to the
“Just culture”: The effectiveness of incident-reporting occurrence, and what defects in the system might be
systems is highly dependent upon the culture of the orga- changed in order to reduce the likelihood of recurrence.
nization within which the reporting is occurring. Aviation Key to an effective RCA process, and similar to the prin-
industry safety-reporting systems are often highlighted ciples discussed above related to “just culture,” RCAs are
for their successes over the past few decades in promot- designed not to ask who was at fault, but rather what sys-
ing reporting of aviation events that might have led to tem reasons contributed to the event. “Why,” not “who,”
accidents. The Aviation Safety Reporting System (ASRS) is the essential question to be asked. The answer to the
prioritizes confidentiality in order to encourage reporting question “why did this occur” almost invariably results
and protects reporters from punishment, with certain in a combination of factors, often illustrated by a series of
limitations when they report incidents, even if related pieces of Swiss cheese where the holes all line up. Taken
to non-adherence to aviation regulations. Although the from the writings of James Reason, the “Swiss Cheese
system is voluntary, more than 880,000 reports have been Model” illustrates the many possible system failures that
submitted and used by the Federal Aviation Administra- can contribute to an error, and contributes to identifying
tion to improve air travel safety. potential system changes that reduce the risk of error
In health care, the variable recognition of adverse recurrence. Strategies for approaching retrospective RCA
events as well as any fear about reprisal for reporting and the causes of human and system error are available at
events both work to reduce the consistent reporting http://www.ncbi.nlm.nih.gov/pmc/articles/pmc1117770.
of events. The concept of “just culture” has been The use of retrospective review processes to learn from
promoted as a strategy to increase the comfort of staff adverse events is frequently now referred to as “Safety 1”
members to report the occurrence of errors or near- approach to health care improvement. Increasingly, safety
misses, even if they may have done something incorrectly. experts are focusing on “Safety 2,” which is complemen-
See the work of David Marx and the “Just Culture tary strategy oriented to learning “when things go right,”
Community” for more information on how to evaluate and designing systems for reliability using approaches
error so as to support reporting and safer practices in common in the field of human factors engineering. A few
organizations. A great deal more information about “just selected reading materials for the interested learner are
culture” principles is available at http://www.justculture.org. listed later.
2
The Newborn Infant
Danielle Smith, MD
Theresa Grover, MD
Table 2–1. New Ballard score for assessment of fetal maturation of newly born infants.a
Neuromuscular Maturity
Score
Neuromuscular Record Score
Maturity Sign –1 0 1 2 3 4 5 Here
Posture
Square window
(wrist)
Arm recoil
Popliteal angle
Scarf sign
Heel to ear
gestational age (AGA), small for gestational age (SGA, also congenital anomalies, cardiomyopathy, hyperbilirubinemia,
known as intrauterine growth restriction [IUGR]), or large and hypocalcemia. SGA infants are at risk for fetal distress
for gestational age (LGA). Birth weight for gestational age in during labor and delivery, polycythemia, hypoglycemia, and
normal neonates varies with gender, race, maternal nutri- hypocalcemia.
tion, access to obstetric care, and environmental factors such
as altitude, smoking, and drug and alcohol use. Whenever ººEXAMINATION AT BIRTH
possible, standards for newborn weight and gestational age
based on local or regional data should be used. Birth weight The extent of the newborn physical examination depends
related to gestational age is a screening tool that should be on the condition of the infant and the setting. Examina-
supplemented by clinical data when entertaining a diagno- tion in the delivery room consists largely of observation
sis of IUGR or excessive fetal growth. These data include plus auscultation of the chest and inspection for congenital
the infant’s physical examination and other factors such as anomalies and birth trauma. Major congenital anomalies
parental size and the birth weight–gestational age of siblings. occur in 1.5% of live births and account for 20%–25% of
An important distinction, particularly in SGA infants, is perinatal and neonatal deaths. Because infants are physically
whether a growth disorder is symmetrical (weight, length, stressed during parturition, the delivery room examination
and occipitofrontal circumference [OFC] all ≤ 10%) or should not be extensive. The Apgar score (Table 2–2) should
asymmetrical (only weight ≤ 10%). Asymmetrical growth be recorded at 1 and 5 minutes of age. In severely depressed
restriction implies a problem late in pregnancy, such as infants, scores can be recorded out to 20 minutes. Although
pregnancy-induced hypertension or placental insufficiency. the 1- and 5-minute Apgar scores have almost no predictive
Symmetrical growth restriction implies an event of early value for long-term outcome, serial scores provide a useful
pregnancy: chromosomal abnormality, drug or alcohol use, description of the severity of perinatal depression and the
or congenital viral infections. In general, the outlook for response to resuscitative efforts.
normal growth and development is better in asymmetrically Skin color is an indicator of cardiac output because of
growth-restricted infants whose intrauterine brain growth the normal high blood flow to the skin. Stress that triggers a
has been spared. catecholamine response redirects cardiac output away from
The fact that SGA infants have fewer problems (such the skin to preserve oxygen delivery to more critical organs.
as respiratory distress syndrome) than AGA infants of the Cyanosis and pallor are thus two useful signs suggestive of
same birth weight, but a lower gestational age has led to the inadequate cardiac output.
misconception that SGA infants have accelerated matura- Skeletal examination at delivery serves to detect obvious
tion. SGA infants, when compared with AGA infants of the congenital anomalies and to identify birth trauma, particu-
same gestational age, actually have increased morbidity and larly in LGA infants or those born after a protracted second
mortality rates. stage of labor where a fractured clavicle or humerus might
Knowledge of birth weight in relation to gestational be found.
age allows anticipation of some neonatal problems. LGA The placenta and umbilical cord should be examined at
infants are at risk for birth trauma. LGA infants of diabetic delivery. The number of umbilical cord vessels should be
mothers are also at risk for hypoglycemia, polycythemia, determined. Normally, there are two arteries and one vein.
0 1 2
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