Support Line Volume 38 No.

5 13
7. Beecher HK. Ethics and clinical research. N Engl J
Med. 1966;274(24):13541360.
8. Krugman S. The Willowbrook hepatitis studies
revisited: ethical aspects. Rev Infect Dis. 1986;
8(1):157162.
9. United States Congress House of the Committee
on Energy and Commerce. Subcommittee on
Energy Conservation and Power. American Nuclear
Guinea Pigs: Three Decades of Radiation Experiments
on U.S. Citizens. Washington, DC: U.S. Government
Printing Office, 1986.
10. Milgram S. Behavioral study of obedience.
J Abnorm Psychol. 1963;67:371378.
11. Katz RV, Kegeles SS, Kressin NR, et al. Awareness
of the Tuskegee Syphilis Study and the US
presidential apology and their influence on
minority participation in biomedical research.
Am J Public Health. 2008;98(6):11371142.
12. The National Commission for the Protection of
Human Subjects of Biomedical and Behavioral
Research. The Belmont Report: Ethical Principles
and Guidelines for the Protection of Human
Subjects of Research. 1979. http://www.hhs.gov/
ohrp/humansubjects/guidance/belmont.html.
Accessed March 2016.
13. C
 ode of Federal Regulations Title 45 Public Welfare,
Department of Health and Human Services, Part 46
Protections of Human Subjects. 2009. http://
www.hhs.gov/ohrp/regulations-and-policy/
regulations/45-cfr-46/index.html Accessed
May 18, 2016.
14. U
 S Code of Federal Regulations. Title 21Food and
Drugs, Chapter IFood and Drug Administration,
Department of Health and Human Services,
Subchapter AGeneral, Part 56 Institutional
Review Boards. 2015. http://www.accessdata.fda.
gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.
cfm?CFRPart=56. Accessed May 18, 2016.
15. Sims JM. A brief review of the Belmont Report.
Dimens Crit Care Nurs. 2010;29(4):173174.
16. IRB considerations after initial approval; Informed
consent requirements; Privacy, confidentiality
and HIPAA. In: Office for the Protection of
Research Subjects (OPRS), Health Sciences
Institutional Review Board (HSIRB), University
Park Institutional Review Board (UPIRB). University
of Southern California Human Subjects Protection
Program (HSPP) Policies and Procedures. 2014:
134197. https://oprs.usc.edu/files/2012/11/
Policies-and-Procedures-Jan-2015.pdf.
Accessed May 18, 2016.
17. USC Institutional review boards (IRBS), Types of
IRB submissions. In: Office for the Protection of
Research Subjects (OPRS), Health Sciences
Institutional Review Board (HSIRB), University
Park Institutional Review Board (UPIRB). University
of Southern California Human Subjects Protection
Program (HSPP) Policies and Procedures. 2014:72
109. https://oprs.usc.edu/files/2012/11/Policiesand-Procedures-Jan-2015.pdf. Accessed February
2016.
18. Byerly WG. Working with institutional review
board. Am J Health Syst Pharm. 2009;66(2):
176184.
19. Casarett D, Karlawish JH, Sugarman J.
Determining when quality improvement
initiatives should be considered research:
proposed criteria and potential implications.
JAMA. 2000;283(17):22752280.
20. OPRS Office for the Protection of Research
Subjects. Types of IRB Review. Los Angeles, CA:
University of Southern California; 2016. http://
oprs.usc.edu/review/typesofirb/. Accessed
May 18, 2016.

Collecting Data to Support

Clinical Nutrition Staffing
Wendy Phillips, MS, RD, CNSC, CLE, FAND
Abstract
Accurate, up-to-date data are essential to support
efforts to maintain or increase registered dietitian
nutritionist (RDN) staffing in inpatient and
ambulatory settings. Subjective pleas for
additional support because of heavy workloads no
longer are effective in todays health care climate.
Important data that can aid in maintaining or
increasing staffing may include benchmarking
of staffing, patient satisfaction, employee
engagement, productivity, and patient outcomes
as well as new site-specific outcomes data. Such
data must be analyzed and presented in a manner
that resonates with the facilitys key decision
makers to gain the support of the health system
administrators who hold the purse strings.

Introduction
The goal of all health care institutions and
clinicians is to make sick people healthier. In 2001,
the Institute of Medicine (IOM) released a pivotal
report, Crossing the Quality Chasm. According
to the report, the American healthcare delivery
system is in need of fundamental change and
quality problems are everywhere affecting many
patients (1). A 2004 publication cosponsored by
the Office of the Inspector General of the U.S.
Department of Health and Human Services and
the American Health Lawyers Association (2)
discusses the 2001 IOM report, stating that the
oversight of quality and patient safety is a core
financial responsibility of all health care
organizations and that promoting quality care
and patient safety are at the center of the health
care industry. In other words, the goal for all in
health care is to improve patient outcomes.
Improving patient outcomes requires research at
several levels to determine which interventions
are effective for specific patient populations.
Although clinicians must understand molecular
and cellular processes to cure or delay the
progression of disease, they also must determine
whether practical application of that research
results in actual improvement in patient
outcomes. Health care institutions also are vitally
interested in financial management outcomes.
Administrators want to know how to provide the
best care to ensure good patient outcomes
within accepted economic parameters.
Primarily for economic reasons, acute-care
hospitals in the United States focus many of their
institutional goals on areas that are deemed
important by The Centers for Medicare &

Kate Willcutts, DCN, RD, CNSC

Medicaid Services (CMS), The Joint Commission,
and other accrediting agencies. The Affordable
Care Act has allowed Medicare to adjust
reimbursement to acute-care hospitals based on
performance (3). Specifically, Medicare can: 1)
reduce reimbursement for excessive unplanned
readmissions or deaths within 30 days of hospital
discharge; 2) adjust payments via the Value-Based
Purchasing program, using the criteria of how
well a given hospital performs compared to
other hospitals (benchmarking) and how much a
hospital improves over its previous performance;
and 3) reduce reimbursement based on the
number of hospital-acquired conditions occurring
in an institution. Medicare also offers a website for
consumers to compare various parameters (4). In
addition, The Joint Commission publishes a list of
National Patient Safety Goals each year (5).
RDNs can use these information sources to guide
efforts at maintaining or increasing staffing by
focusing on hospital goals on which the RDN has
an impact. For example, the RDN could gather
data from performance improvement projects on
patient satisfaction, postoperative complications,
hospital-acquired pressure ulcers, unplanned
30-day readmissions, or glucose control in heart
surgery patients.
After gathering the data, the RDN must analyze
it. The first step in analysis is to establish a
benchmark against which to measure the need for
improvement. The benchmark is the measurement
that defines success or the needed goal and is the
standard against which other measurements are
compared. A benchmarking program evaluates
individual performance against the benchmark
and determines where improvement is needed (6).
Many health care benchmarks have been
established, including several that are relevant to the
nutrition support practitioner. The American Society
for Parenteral and Enteral Nutrition systematically
reviews research conducted at the molecular,
clinical, and societal levels, using those data to create
clinical practice guidelines with benchmarks for
making treatment recommendations (7). One
example of this process is the clinical practice
guideline recommending a target blood glucose
range of 140 to 180 mg/dL in the adult hospitalized
patient receiving enteral or parenteral nutrition
support, which is based on patient outcomes
research (8). A financial health care management
benchmark example is the standard ratio of patients
assigned to each registered nurse per shift, which
(Continued on next page)

14 Support Line October 2016

is established by studying patient outcomes for
quality and safety compared to the assigned ratio.
Of note, once these benchmarks are established,
they must be periodically reevaluated for
effectiveness and changed if needed.
This article addresses how data, in the form of
benchmark comparisons, productivity statistics,
and outcomes measurements, can help justify
appropriate RDN staffing. The step-by-step guide
to conducting an outcomes measurement
process is presented using examples of: 1) a
patient outcome study of patients receiving
home enteral nutrition (EN) and 2) a financial
management example of establishing RDN-topatient ratios for inpatient acute-care facilities
to ensure the best patient outcomes.

Patient Outcome Scenario

Oftentimes an experiential observation creates
the impetus for conducting outcomes research.
Consider the example of a nutrition support RDN
who believes that she frequently sees home EN
patients readmitted to the hospital for nutritionrelated complications. She has pursued funding
for additional outpatient nutrition support
dietitian hours to help troubleshoot and prevent
complications, but hospital administration has
repeatedly denied the requests. Her previous
efforts centered on comparing patient-to-RDN
ratios. She now decides to focus on a patient
outcome that she believes would resonate more
with hospital administration. Accordingly, she
designs a project to establish the 30-day
readmission rate, as well as the reason for
readmission, for patients discharged home on
tube feeding.

Financial Management Scenario

No standardized RDN-to-patient ratios exist for
acute care facilities (9,10), although recently
published studies have helped to establish

baseline benchmarks for the number of patients

seen per day and the amount of time spent with
patients (11,12). The members of an inpatient
clinical nutrition team believe that they are seeing
too many patients each day to comply with the
facilitys policies, complete thorough nutrition
assessments, and establish effective nutrition care
plans. Due to the lack of both a standardized
RDN-to-patient ratio and outcomes data, hospital
administration is unwilling to fund additional
RDN positions. Therefore, the clinical nutrition
management team decides to collect and analyze
data from various sources, such as productivity
reports and characteristics of patients who receive
RDN interventions, to develop a stronger proposal
for increased staffing.

Evaluation Steps
The first step in the evaluations cited in the
previous scenarios and others like them is to
recognize a process that needs improvement and
establish the baseline. Before evaluating patient
outcomes after a change in process or nutrition
intervention, clinicians must describe the current
state of affairs, that is, establish the benchmark.
The current patient population should be
evaluated and described quantifiably to establish
baseline benchmarks against which future
improvements can be measured.
In the first scenario, a descriptive study showing the
number of patients discharged on tube feedings
and the percent of these who are readmitted to the
hospital or emergency department (ED) within a
given time frame can help to determine if the
problem is as substantial as the perception based on
experiential observation. For other scenarios,
clinicians can establish benchmarks by participating
in mandatory health care benchmark programs such
as a patient satisfaction program or comparing
conditions such as hospital-acquired pressure ulcer
prevalence against the national benchmark

established by tracking the prevalence of the

condition at multiple hospitals. In the patient
outcome measurement example of reducing
readmission rates for home EN patients, the RDN
ideally would design an outcomes study to evaluate
if nutrition intervention by an RDN makes a
difference in readmission rates and then pursue
funding or staffing reallocation to pursue a pilot
project.
For the second scenario on financial
management, the baseline benchmark should
accurately describe the current average RDN time
spent with patients and the average number of
patients per day. The next step is to measure
patient outcomes based on RDN time spent per
patient or number of patients assigned to the
RDN each day. If these data support the need for
increased staffing, RDNs can track outcomes to
justify and maintain staffing.
After establishing the baseline or benchmark,
clinicians should determine the ideal goal state.
Often, this means reaching an already established
benchmark. For example, in financial
management outcomes research, the goal would
be revenue growth projections for a company.
Historical financial data are used to generate
projected goals for the upcoming defined time
period. In health care, benchmark data on
national safety goal metrics, such as central
line-associated bloodstream infections, falls, or
catheter-associated urinary tract infections, are
used by institutions as they set goals for the
upcoming time periods. In other instances, a goal
must be created. In the home EN scenario, the
ideal state has not been set as a national goal.
However, clinicians and administrators at an
institution may agree on a goal of 0% to 2%
of patients readmitted with nutrition-related
complications. Similarly, no current ideal state or
(Continued on page 16)

Table. Evaluation Factors for Establishing Health Care Benchmarks

Factor to Consider

Example Metrics for Patient Outcome Scenario Example Metrics for Financial Management Scenario

Describe the
current situation

How many patients were discharged on home tube feeding

compared to the overall number of patients discharged?
How many of these home EN patients were readmitted
or visited an ED within 30 days?
How many of these readmissions were due to
nutrition-related complications?

On average, how many patients per day are RDNs seeing?

What percent of time is spent in direct patient care activities?

Determine indications
Readmission rates or ED visits in home EN patients
of the need
compared to all patients discharged to home
for improvement
Costs associated with readmissions and ED visits

Reports of RDN dissatisfaction with clinical workload

Poor patient nutrition-related outcomes
Patients who need nutrition intervention are not assessed
by an RDN

Determine indications
of success

High employee engagement for RDNs

Fewer nutrition-related adverse health care events for patients
Improved outcomes such as shorter length of stay, fewer
hospital readmissions, fewer ED visits, and more discharges
to home rather than to skilled nursing/rehabilitation facilities

Decreased readmissions or ED visits within 30 days

Improved quality of life for patients
Fewer long-term complications for home EN patients

ED=emergency department, EN= enteral nutrition, RDN=registered dietitian nutritionist

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recommended benchmark exists in the RDN
staffing example (9,10). When seeking to
establish a new benchmark or to revise an
existing one, clinicians must examine several
factors, including the current state, indications
that improvement is needed, and indicators of
success (Table).

Establishing the Benchmark

The first question for the patient outcome
scenario is whether a large percentage of
patients who are discharged home with EN are
readmitted to the hospital or visit the ED within
30 days of discharge. Collaboration with the
institutions information technology, quality, or
clinical data repository departments is essential
to obtain these data. This required information
includes a list of patients discharged home within
a given time period on EN and ideally information
on which of those patients were readmitted or
visited the ED within 30 days. Once that data set
is generated, the RDN can review the charts of
the readmitted patients to determine if the
readmissions were related to a predetermined list
of nutrition complications such as dehydration,
failure to thrive, malabsorption, feeding tube
problems, or other reasons. A tolerance threshold
needs to be established, usually in collaboration
with hospital administration, the finance
department, and physician leadership, for when
the readmission rate is too high. Given the CMS
penalties for readmissions (13), expected
readmission rates for preventable complications
is likely to be near to 0%. Because many nutrition
complications in home EN patients could be
prevented, resulting in fewer admissions, RDNs
citing these statistics are sure to gain attention
from hospital administrators.
Of note, these are observational data describing
the current situation, not patient outcomes
research, but this type of information can help
establish the need for further study and secure
dedicated financial resources to identify
improvement opportunities and fund the
outcomes-based research. For example, the RDN
may identify that 100 patients were discharged
home on EN over a 1-year period. Of these, 10
patients (10% of the population) were readmitted
within 30 days with dehydration and/or failure
to thrive due to inadequate outpatient follow-up
for troubleshooting of complications. These
10 readmissions may have cost the hospital an
average of $9,000 per patient or a total of
$90,000. In addition, although some of the
90 other patients were not readmitted to the
hospital within 30 days, their medical outcomes
could be theorized to be worse due to less-thanoptimal nutrition management at home.
Accordingly, justification could be made to fund
a part-time RDN to help manage home EN
and avoid nutrition complications that lead to
readmission because the RDN salary plus benefits

over 1 year would likely be less than the $90,000

cost for readmitting 10% of the patients
discharged on EN. Funding for the position
should include time dedicated for patient
outcome measurement in addition to direct
patient care management time.

Developing the Data Collection Tool

Designing the data collection tool is arguably the
most important step in conducting outcomes
research. The data must be collected so as to
facilitate data analysis as well as answer the
question(s) being asked. Consulting a statistician
or research expert in the initial design phase can
be invaluable because he/she can help design a
tool that allows use of appropriate statistical tests
after data collection is complete. In addition, such
experts can provide recommendations for the
necessary sample size to show a significant
difference (statistical power), help with
randomization of patients in clinical outcomes
research, and clarify the metrics being evaluated.
Internal and external stakeholders should provide
input early in the overall process to help establish
meaningful outcomes to measure and metrics that
should be used in benchmarking. The stakeholders
who will be evaluating the end result and financial
implications of the recommended changes need
to be fully invested and approving of the system
used to establish the new benchmarks. A sample
size of 30 hospitals collecting productivity data
over a 2-month period to establish benchmarks for
average time spent per patient and number of
patients seen per day may be sufficient to show
statistical significance, but stakeholders are
unlikely to think that the results from a 30-bed
hospital would be applicable to a large, universityaffiliated hospital. Thus, their involvement early in
the design and implementation process is vital to
eventual success.
Similarly, hospital administrators, physicians,
and others who read outcome studies that are
conducted in settings or with patient populations
that differ from theirs may respect the work, but
they may not believe that the results are
applicable in their own hospital or with their own
patient population. Therefore, conducting the
same or a similar study in ones own hospital may
be necessary to determine whether the same
interventions produce the same results. If the
initial study is carefully designed and the methods
are adequately described in the literature,
clinicians should be able to replicate it to see if
the results are generalizable to other hospital(s).

the data, they must communicate frequently to

ensure that data are being collected using
standardized, reproducible methods. As in the
case of productivity monitoring data, where
multiple RDNs are contributing data to a
centralized location, contributors require
repeated education in a variety of formats
to ensure consistency of data reporting.

Analyzing the Data

If data collection has been properly planned
and executed, analysis should be relatively
straightforward. A description of appropriate
statistical tests is beyond the scope of this article;
RDNs should consult a statistician or research
expert to be sure the test applied is appropriate
for the question(s) being analyzed. Thresholds for
significance should be determined to evaluate
if a statistical significance is reached (in other
words, to be sure that the difference is not due
to random chance). Further, researchers should
determine whether the difference is also clinically
significant.

Presenting the Data to Key Stakeholders

Accumulated data must be represented in a
manner that is meaningful to the intended
audience. The RDN should create a relatively
lengthy summary of the project, including
background, methods, raw data, analysis, and
multiple charts and graphs. This written piece is
important to document the required work that
went into the project and to have available for
those who are interested in the finer details.
However, this document usually is pared down
to the primary message that can be presented
succinctly to the key stakeholders. Graphic
representation of the results is particularly
effective. Finally, an elevator speech (~30-60
seconds long) works best to summarize the
project.

Conclusion

Collecting the Data

In the current health care climate, documenting

benefits of nutrition interventions to patient
safety, patient satisfaction, patient outcome, cost
savings, and employee engagement is essential
to maintaining and increasing RDN staffing.
Requests for additional staffing that are not
supported by data are likely to be rejected. The
RDN can work to maintain and increase RDN
staffing by tracking productivity and outcomes,
comparing to benchmark data, and conducting
outcome studies. This information must be
analyzed and presented within the parameters of
an individual institutions goals and mission and
presented effectively to the institutions key
decision makers.

After the data collection tool is created, the focus

turns to consistency and accuracy in collecting
data. Limiting the number of researchers and/or
the number of people collecting the data may be
appropriate. If more than one person is collecting

Wendy Phillips, MS, RD, CNSC, CLE, FAND, is

Corporate Director, Clinical Support Morrison
Healthcare, Saint George, UT, and Kate Willcutts,
DCN, RD, CNSC, is Co-Director Clinical Nutrition,

Support Line Volume 38 No. 5 17

University of Virginia Health System, Charlottesville,
VA.

References

1. Institute of Medicine. Crossing the Quality Chasm:

A New Health System for the 21st Century.
Washington, DC: National Academy of Sciences;
2000. http://www.iom.edu/Reports/2001/
Crossing-the-Quality-Chasm-A-New-HealthSystem-for-the-21st-Century.aspx. Accessed
May 17, 2016.
2. Callender AN, Hasings DA, Hemsley MC, Morris L,
Peregrine MW. Corporate Responsibility and Health
Care Quality: A Resource for Health Care Boards of
Directors. Washington, DC: U.S. Department of
Health and Human Services Office of Inspector
General; American Health Lawyers Association;
2004. https://oig.hhs.gov/fraud/docs/compliance
guidance/CorporateResponsibilityFinal%20
9-4-07.pdf. Accessed May 17, 2016.
3. C
 ode of Federal Regulations: Medicare Program;
Hospital Inpatient Value-Based Purchasing
Program. 42 CFR Parts 422 and 480; 2011.
4. Hospital Compare. Linking quality to payment.
Medicare.gov. https://www.medicare.gov/
hospitalcompare/linking-quality-to-payment.
html. Accessed March 21, 2016.
5. The Joint Commission. 2016 National Patient
Safety Goals. 2016. http://www.jointcommission.
org/standards_information/npsgs.aspx. Accessed
March 21, 2016.
6. Phillips W. The value of benchmarking. Todays
Dietitian. 2015;17(2):4449. http://www.
todaysdietitian.com/newarchives/021115p44.
shtml. Accessed May 17, 2016.
7. American Society for Enteral and Parenteral
Nutrition. Clinical Guidelines. http://www.
nutritioncare.org/Guidelines_and_Clinical_
Resources/Clinical_Guidelines/. Accessed
January 5, 2016.
8. McMahon MM, Nystrom E, Braunschweig C, Miles
J, Compher C; American Society for Parenteral
and Enteral Nutrition (A.S.P.E.N.) Board of
Directors; American Society for Parenteral and
Enteral Nutrition. A.S.P.E.N. clinical guidelines:
nutrition support of adult patients with
hyperglycemia. JPEN J Parenter Enteral Nutr.
2013;37(1):2336.
9. Biesemeier C. Achieving Excellence: Clinical Staffing
for Today and Tomorrow. Chicago, IL: American
Dietetic Association; 2004.
10. Marcason W. What is ADAs staffing ratio for
clinical dietitians? J Am Diet Assoc. 2006;
106(11):1916.
11. Phillips W. Clinical nutrition staffing benchmarks
for acute care hospitals. J Acad Nutr Diet. 2015;
115(7):10541056.
12. Hand RK, Jordan B, DeHoog S, Pavlinac J, Abram
JK, Parrott JS. Inpatient staffing needs for
registered dietitian nutritionists in 21st century
acute care facilities. J Acad Nutr Diet. 2015;
115(6):9851000.
13. Department of Health and Human Services,
Centers for Medicare & Medicaid Services. Acute
Care Hospital Inpatient Prospective Payment
System. 2016. http://www.cms.gov/Outreachand-Education/Medicare-Learning-NetworkMLN/MLNProducts/downloads/Acute
PaymtSysfctsht.pdf. Accessed January 21, 2016.

Nontraditional Roles for the

Nutrition Support Professional:
Expanding Roles as Nutrition Experts
Maya M. Morrison, MSRD, CSP

Elizabeth Pash, MS, RD, LDN

Abstract
Health care reform and changes in policy have
brought about an increased focus on costs,
quality, and transparency of care (1). In 2013, the
Alliance to Advance Patient Nutrition proposed
a model that redefined clinical roles of the
nutritional professional and proposed an
interdisciplinary approach to better diagnose and
treat malnutrition in hospitalized patients. Both
enteral and parenteral industry partners have
begun to develop programs and partnerships
with health care professionals and national
organizations to support this effort. This has
led to greater demand within the industry for
nutrition professionals who have experience
in clinical, academic, and research settings to
fill positions beyond traditional sales and
commercial roles. The Accreditation Council for
Continuing Medical Education (ACCME) has
released specific standards for collaboration with
for-profit organizations that support continuing
medical education activities. The ACCME also
developed standards for clinicians who work in
for-profit organizations (2). This article reviews
the experiences of two nutrition support
professionals who work in industry and provides
a general overview of the areas in which clinical
nutrition expertise can be of significant value
outside of clinical venues.

The Role of Medical Affairs in the

Medical Device/Pharmaceutical
and Nutrition Industry
Enhanced medical care not only requires a deep
comprehension of product knowledge but
also a robust, informed view of the needs,
requirements, expectations, and perspectives
of various health care stakeholders. Substantial
research, resources, and time go toward the
development of new products or drugs.
Corporate organizations must make a long-term
commitment to each new product before launch.
The Medical Affairs operations within a
pharmaceutical, nutrition, or medical device
company essentially encompass exchange of
scientific information with internal and external
stakeholders, with the ultimate goal of translating
medical science into value for the business and,
most importantly, for the patient via adequate
and safe use of commercial products. This
division or department interacts with physicians
and other clinicians who use or are involved with

research related to the companys products.

Such departments are responsible for medical
communications with prescribers, provision of
grants to fund investigator studies, and other
research. In addition, the Medical Affairs
department usually handles off-label usage,
publications, safety information, and
independent medical and/or clinical education.
Generally, these departments are staffed by
individuals with advanced clinical and scientific
degrees that enable them to communicate the
science behind a device or product to end users.
The U.S. Food and Drug Administration (FDA) and
the U.S. Department of Health and Human
Services Office of Inspector General (OIG)
encourage and support Medical Affairs to
facilitate effective and legally compliant
communications between life science companies
and health care professionals. The creation and
maintenance of a Medical Affairs department
is clearly endorsed by the OIG and FDA, as
evidenced in agency guidance and various
corporate integrity agreements (3). According to
the OIG, separation of sales and Medical Affairs is
critical with respect to research, consulting, and
grant funding (3). Medical Affairs departments
should report to an organizations c-suite (Chief
Executive Officer, Chief Financial Officer, and
Chief Operating Officer among other key
administrative leaders), compliance officer, or
research and development rather than to a
commercial department, thus separating the
two functions in the organization.
The Figure depicts the general structure of
Medical Affairs within pharmaceutical and
medical device industries, with some variances
noted within particular organizations.
The Table provides a glossary of common
terminology used in the medical and
pharmaceutical industry.

Medical Science Information

One of the positions within a Medical Affairs
department for which nutrition professionals
might be qualified is medical science liaison
(MSL). These individuals have advanced degrees
that enable them to interact with physicians and
other clinicians on a clinical peer-to-peer level.
MSLs are often part of the medical information
team and work with other scientific members of
(Continued on next page)