653833

research-article2016
NCPXXX10.1177/0884533616653833Nutrition in Clinical PracticeBoullata et al

Special Report
Nutrition in Clinical Practice
Volume 31 Number 4
Standardized Competencies for Parenteral Nutrition August 2016 548­–555
© 2016 American Society
Order Review and Parenteral Nutrition Preparation, for Parenteral and Enteral Nutrition

Including Compounding: The ASPEN Model DOI: 10.1177/0884533616653833

ncp.sagepub.com
hosted at
online.sagepub.com

Joseph I. Boullata, PharmD, RPh, BCNSP, FASPEN, FACN1;

Beverly Holcombe, PharmD, BCNSP, FASHP2; Gordon Sacks, PharmD, BCNSP3;
Jane Gervasio, PharmD, BCNSP4; Stephen C. Adams, MS, RPh, BCNSP5;
Michael Christensen, PharmD, BCNSP6; Sharon Durfee, RPh, BCNSP7;
Phil Ayers, PharmD, BCNSP, FASHP8; Neil Marshall, RN, BSN, MSAOM, CRNI, CNSC9;
and Peggi Guenter, PhD, RN, FAAN2; for the Parenteral Nutrition Safety Committee,
American Society for Parenteral and Enteral Nutrition

Abstract
Parenteral nutrition (PN) is a high-alert medication with a complex drug use process. Key steps in the process include the review of
each PN prescription followed by the preparation of the formulation. The preparation step includes compounding the PN or activating
a standardized commercially available PN product. The verification and review, as well as preparation of this complex therapy, require
competency that may be determined by using a standardized process for pharmacists and for pharmacy technicians involved with PN. An
American Society for Parenteral and Enteral Nutrition (ASPEN) standardized model for PN order review and PN preparation competencies
is proposed based on a competency framework, the ASPEN-published interdisciplinary core competencies, safe practice recommendations,
and clinical guidelines, and is intended for institutions and agencies to use with their staff. (Nutr Clin Pract. 2016;31:548-555)

Keywords
drug compounding; parenteral solutions; parenteral nutrition; competence; safety

Parenteral nutrition (PN) is a high-alert medication with a
complex drug use process. The practices and the safeguards,
including policies, procedures, and supportive systems that
surround this process, are critical to maintaining patient safety.
In 2013, patients received PN during approximately 302,000
hospital stays, while many others received it in the home or
long-term care settings.1 The expectations are that standardiza-
tion across the process and communication between healthcare
providers support patient safety, especially when each provider
is competent in his or her role. The ultimate goal is to reduce
PN-related medication errors. Compared with most other med-
ications, the order review and the preparation steps for PN are
time and effort intensive. Competence needs to be shown by
pharmacists and pharmacy technicians involved in reviewing
and preparing PN.
Organizations vary in how they verify and the degree to
which they review PN orders. A national survey indicated that
60% of organizations dedicate at least 0.6 full-time equivalents
(FTEs) to verify, review, and clarify PN orders.2 Unfortunately,
23% do not dedicate any pharmacist time to this critical activity.
For those who do review PN orders, 90% of respondents report
that clarifications are required for up to 25% of all PN orders.
These range from illegible orders and missing information to
dosing and compatibility and stability concerns.2 Judicious PN
order review and modification are critical to optimize patient
safety. Therefore, competent pharmacists should identify and
clarify inappropriate PN orders prior to preparation. Interventions
From 1Drexel University and Hospital of the University of Pennsylvania,
Philadelphia, Pennsylvania, USA; 2ASPEN, Silver Spring, Maryland,
USA; 3Auburn University, Auburn, Alabama, USA; 4Butler University,
Indianapolis, Indiana, USA; 5Vitaline Infusion Pharmacy Services,
Geisinger Medical Center, Danville, Danville, Pennsylvania, USA;
6
University of Tennessee, Memphis, Tennessee, USA; 7Poudre Infusion
Therapy, Fort Collins, Colorado, USA; 8Mississippi Baptist Medical Center,
Jackson, Mississippi, USA; and 9Walgreens, Sun Valley, California, USA.
This document has been approved by the ASPEN Board of Directors.
Financial disclosure: None declared.
Conflicts of interest: J. I. Boullata is a consultant for Fresenius Kabi. G.
Sacks has received support from Fresenius Kabi. S. Durfee is an employee
of CAPS/BBraun. N. Marshall is an employee of Option Care. P. Ayers is
a consultant for Fresenius Kabi, Baxter, and B. Braun. M. Christensen-Data
and Safety Monitoring Board Membership-Fresenius Kabi. P. Guenter, B.
Holcombe, S. C. Adams, and J. Gervasio have nothing to disclose.
This article originally appeared online on June 17, 2016.
Corresponding Author:
Joseph I. Boullata, PharmD, RPh, BCNSP, FASPEN, FACN, Clinical
Professor, Drexel University, and Pharmacy Specialist in Nutrition
Support, Hospital of the University of Pennsylvania, Philadelphia, 3400
Spruce St., Philadelphia, PA 19104, USA.
Email: Joe.Boullata@uphs.upenn.edu
Boullata et al 549
pursuant to this significant workload are often considered inher-
ent to the workflow and therefore rarely documented such as a
“near-miss” error. Permanent and easily retrievable documenta-
tion is valuable to further determine appropriate practices. The
review step is often not described or is otherwise subsumed
within the compounding step. This is clearly an independent step
that may occur at a distant site from compounding. This task
requires competence, especially given that 19%–21% of organi-
zations outsource PN preparation to a vendor.2,3
The preparation step can also vary between organizations.
PN preparation includes compounding—whether customized to
a patient’s specific needs or meeting an organization-specific
standard formulation with fixed proportions of macronutrients.
Preparation also includes the activation of a standardized com-
mercially available PN product (often referred to as a multi-
chamber bag) with admixture of additional additives as required.
Automated compounding devices (ACDs) are used to prepare
PN in up to 64% of organizations, especially larger institu-
tions.2,3 Standardized commercially available PN products are
used by 21%–43% according to recent surveys.2,3 These prod-
ucts are used more often in smaller institutions, although it is
not clear whether the use of the commercially available PN
product, let alone PN, is always indicated.2,3 At least 10% of
organizations still use a gravity method to prepare PN.3 The
“gravity” method refers to combining of the major ingredients
from their original source container into the final PN container
through tubing by the force of gravity without automated
means. ACDs infrequently (18%) interface electronically with
the order entry system, requiring manual transcription by a
pharmacist or pharmacy technician. If any transcription steps
remain in place (diverging from recommended best practices),
an independent double-check and documentation of the same
needs to take place. Regardless of method, PN preparation also
requires appropriate labeling, dispensing, and storage. The
beyond-use date (BUD) assigned to PN preparations seems to
vary considerably between organizations.2
Recently published American Society for Parenteral and
Enteral Nutrition (ASPEN) PN clinical guidelines and safety
consensus recommendations addressed the current limitations
in education and training of pharmacists. Until this is reme-
died, it is incumbent upon organizations to provide in-depth
training programs for staff involved in PN order review and
compounding. Regulatory oversight of PN compounding is
extensive,4–7 and best PN practices described in ASPEN guid-
ance documents include order review and compounding.8,9
Regardless of where the order is being reviewed or where the
admixture is being prepared, the individuals directly involved
are expected to meet basic initial competencies and undergo
competency assessments at regularly set intervals.
Although there has been growth of pharmacy specialists
through postdoctoral training programs and board certification,
this growth has not been seen in the nutrition support specialty
in recent years. Given the limited number of board-certified
pharmacists in positions overseeing PN, the lack of widespread
regulatory requirements for pharmacy technician certification,
and the recent publication of the ASPEN PN clinical guidelines
and safety consensus recommendations, the next logical step is
to develop a model for standardized competencies around PN
order review and PN preparation available for organizations to
use.8,9 A model for PN standardized competencies would allow
for consistency between institutions and offer a template for
those involved in PN order review and PN preparation.
General Nutrition Competencies
This section reiterates the introduction to competencies as
described in previous ASPEN documents.10,11 Competency
goes beyond just knowledge and skills to target and validate an
individual’s ability to perform his or her role safely. Established
competencies allow an individual clinician and his or her
supervisor to assess that clinician’s knowledge and skills as
part of his or her performance review. Core competencies in
nutrition support can be supplemented with PN-specific com-
petencies for each step in the PN use process.10,11
Building programs and tools for patient safety and profes-
sional accountability has long been a goal for ASPEN. In his
2002 ASPEN presidential address, Philip Schneider stated,
“The tools that can be used to improve patient safety include
self-assessment of practitioners who routinely use nutrition
support in their practice, curricular-based continuing education
programs, board certification in nutrition support practice, and
the use of clinical guidelines to assist in making clinical deci-
sions. By developing and promoting these tools, ASPEN is
committed to building a safe nutrition system so every patient
receives optimal nutrition care.” Competencies are a strong
evaluation tool to build that safe PN system.12
A competency framework is a collection of competencies
thought to be central to effective performance and includes
guiding principles to optimize patient safety. Developing com-
petencies should help individuals to continually improve their
performance and to work more effectively.13 If acquired and
maintained, the competencies in this framework should also
help those involved to be safe as well as effective.14 This com-
petency framework underpins the pharmacist’s personal
responsibility for PN order review and preparation (Table 1).
Pharmacist and Pharmacy Technician
Competence With PN Order Review and
Preparation
Pharmacists reviewing PN orders need to be knowledgeable in
all aspects of PN, including vascular access devices, clinical
indications, interpretation of physical examination and labora-
tory findings, appropriate dosing, clinical and metabolic com-
plications, physicochemical principles, interpreting stability,
and compatibility data.15 The pharmacists and pharmacy
550 Nutrition in Clinical Practice 31(4)

Table 1.  Selected Competencies Pertinent to Parenteral Nutrition Order Review and Preparation.14

Competency A: Safe
●  Knows the limits of his or her own knowledge and skill and works within them.
●  Knows when to refer to or seek guidance from another member of the team or a specialist.
●  Can accurately calculate doses and routinely checks calculations where relevant, for example, for children.
●  Keeps up to date with advances in practice and emerging safety concerns related to order review and compounding.
●  Knows about common types of medication errors and how to prevent them.
●  Ensures that confidence and competence to review and compound orders are maintained.
●  Makes accurate, legible, and contemporaneous records and clinical notes of order clarifications.
●  Effectively uses the systems necessary to review and prepare medicines (eg, electronic medical record, decision support).
Competency B: Professional
●  Accepts personal responsibility for and understands the legal and ethical implications of doing so.
●  Makes decisions based on the needs of patients and not the healthcare provider’s personal considerations.
●  Knows and applies legal and ethical frameworks affecting practice (eg, compounding regulations, approach to product shortages).
●  Takes responsibility for own learning and continuing professional development.
●  Maintains patient confidentiality in line with best practice and regulatory standards and contractual requirements.
Competency C: Always Improving
●  Learns and changes from reflecting on practice.
●  Shares and debates own and others’ practice and acts upon feedback and discussion.
●  Acts upon colleagues’ inappropriate practice using appropriate mechanisms.
●  Understands and uses tools to improve (eg, review of data, audit, and feedback).
●  Reports errors and near misses, reviews practice to prevent recurrence.

technicians involved in preparing the PN have a significant role
to play in ensuring safe and appropriate use. They make sure
that each dispensed PN is appropriate for the patient and pre-
pared using the best compounding practices. Unfortunately,
there are a multitude of case reports detailing adverse outcomes,
including sentinel events from inappropriate preparation.8,9,16–29
Attention has been given to prescribing errors that are reflected
in the compounded PN without shedding significant light on the
critical review step that in some cases did not exist.
The use of checklists in healthcare has expanded in recent
years to complement reliance on memory and experience in the
complex care of patients. The airline industry has long used
checklists as a safety tool—not just for the infrequent emer-
gency condition but just as importantly for the routine every-
day situation. Free to access checklists is available from
ASPEN to help standardize and streamline the process of PN
order review and PN preparation.30,31
Regardless of whether PN is prepared on site, is outsourced
to a compounding vendor, or makes use of multichamber
fixed-dose products, a standardized process for PN order
review and preparation is an important safety process that can
then be used to train and assist in privileging pharmacists,
pharmacy residents, pharmacy students, pharmacy technicians,
and technician students as appropriate. A secondary gain from
this competency model might be more standardized patterns of
order review and preparation that could help improve patient
safety by decreasing related errors.
The competency recommendations within this document
are intended for discussion and adoption over time by organi-
zations involved in the reviewing and/or preparing of PN.
These recommendations are not intended to supersede the
judgment of the healthcare professional or employing institu-
tion based on the circumstances of the individual patient.
Pharmacists
The pharmacist involved in PN therapy is an integral part of
the multidisciplinary nutrition care team, whether a formal
nutrition support service is in place or not.15 This critical
team member serves as an important resource, and every
attempt should be made to have the pharmacist involved in
full team clinical, patient care rounds. The concept of phar-
macists expanding patient care roles such as disease man-
agement and prescribing is contingent upon the determination
of the pharmacist’s competency. Competency can be
addressed in part by obtaining continuing education credits,
maintaining licensure, and becoming certified in a clinical
specialty.32,33 The Board of Pharmacy Specialties (BPS) has
a nutrition support pharmacy specialty certification program,
and the National Board of Nutrition Support Certification
(NBNSC) identifies the certified as a qualified nutrition sup-
port provider.34,35 Each certifying board has specific pro-
cesses in place for maintaining certification and for
recertification. A BPS task force is also considering whether
sterile compounding may qualify for its own specialty certi-
fication.35 Pharmacists have been heavily involved in the PN
compounding process, and these collaborations have led to
more appropriate PN therapy, earlier transition to enteral
nutrition (EN) therapy, and recognition of pharmacists as a
resource for providers.36
Boullata et al 551

Table 2.  Questions Addressed by the ASPEN Recommendations for PN Order Review.8,9

●  What are the essential components or attributes for safely transmitting PN orders to pharmacists for review and verification?
●  What is the maximum safe osmolarity of PN admixtures intended for peripheral vein administration?
●  What macronutrient dosing limits are expected to provide for the most stable total nutrient admixtures (3-in-1 admixtures)?
● What are the most appropriate recommendations for optimizing calcium (gluconate) and (Na– or K–) phosphate compatibility in PN
admixtures?
●  Is it safe to use the PN admixture as a vehicle for nonnutrient medication delivery?
●  What improvements in the PN review and verification processes will enhance the safety of PN therapy?
●  What processes can healthcare organizations implement to improve the safety of PN therapy during shortages of PN components?

ASPEN, American Society for Parenteral and Enteral Nutrition; K–, potassium; Na–, sodium; PN, parenteral nutrition.

Table 3.  Questions Addressed by the ASPEN Recommendations for PN Compounding.8,9

●  What compounding errors have been caused by deficits in knowledge, lack of training, competency, and proficiency?
● What compounding errors have been caused by a lack of standardized educational curriculum in schools of pharmacy or pharmacy
technician programs?
●  How can organizations avoid PN errors by implementing soft and hard limits on an ACD?
●  What role does United States Pharmacopeia (USP) Chapter <797> play in preventing PN errors?
●  What are the steps healthcare organizations can take to improve the PN label and labeling system?

ACD, automated compounding device; ASPEN, American Society for Parenteral and Enteral Nutrition; PN, parenteral nutrition.

Pharmacy Technicians competencies for colleagues in the organization who

Pharmacy technicians involved in preparing PN should
complete a standardized training program, whose curricu-
lum should include compounding sterile preparations, vali-
dation of sterile compounding techniques, pharmacy
calculations related to PN, training with ACD if used, and
education pertinent to PN. The degree of practical experi-
ence may vary, but certification of pharmacy technicians
should be a minimum requirement for involvement in PN
preparation. The Pharmacy Technician Certification Board
(PTCB) oversees certification of these healthcare profes-
sionals.37 While all states accept PTCB certification, phar-
macy technicians are currently regulated in 45 states. A
PTCB task force is now considering advanced certification
for sterile compounding.
ASPEN Model for PN Order Review and
PN Preparation Competencies
Based on the recommendations from the ASPEN Consensus
Recommendations and Clinical Guidelines that addressed spe-
cific questions (Tables 2 and 3), the following competencies
should be met for the institutions to privilege the pharmacist
and/or pharmacy technician involved with PN:
1. Pharmacist shall have the appropriate licensure or cre-
dential for his or her profession.
2. The pharmacist should be board-certified, preferably
as a nutrition support pharmacy specialist. An alterna-
tive is to have a board-certified nutrition support phar-
macy specialist on staff who develops and oversees
review and/or prepare PN.
3. If not board-certified in nutrition support, the phar-
macist shall complete a didactic/interactive course
such as the ASPEN professional development mate-
rial (eg, Interdisciplinary Review Course, Nutrition
Support Fundamentals & Review Course, the mod-
ule-based Self-Assessment program, or any of a
number of on-demand webinars) in addition to the
American Society of Health-System Pharmacists
(ASHP) resources for sterile compounding.38–40 An
alternative course would be a facility or organiza-
tionally developed program for initial competency.
The course should also include a pretest and posttest
to assess learning. Such a program must include the
following:
•• PN indications
•• PN venous access
•• Macronutrient and micronutrient requirements in
health but also based on age, disease states, clinical
conditions, organ dysfunction, and concurrent
interventions, including pharmacotherapy
•• Fluid, electrolyte, and acid-base balance basic con-
cepts and principles
•• PN ordering
•• Monitoring and complication prevention and
management
•• United States Pharmacopeia (USP) chapter <797>
•• ACD setup and verification
•• Managing PN component shortages and outages
•• Evaluating and selecting an outsource compound-
ing facility
552 Nutrition in Clinical Practice 31(4)

Adult / Pediatric / Neonatal

(Circle applicable patient population)
Case #________
Pharmacist_____________________________________________________
Verified by____________________________________________________

Date Competency Competency Review Evaluator’s

Met Needed Initials
    Verify PN order elements for:
Patient name and other identifiers
Birth date and or age
Allergies and associated manifestations
Height and dosing weight (metric units)
Diagnoses
Indication(s) for PN
Administration route and vascular access device
Prescriber contact information
Date and time the PN order was submitted
Administration date and time
Volume and infusion rate
Infusion schedule (continuous vs cyclic)
Rate of infusion tapered up/down if appropriate
Type of formulation (dextrose/amino acids or total nutrient admixture)
    Verify PN ingredients for:
Amounts per day (adults); Amounts per kg per day (pediatrics, neonates)
Electrolyte ion doses as a salt form
A dose for each macronutrient
A dose for each electrolyte salt
A dose for fixed-dose multi-trace element product
A dose for individual trace element salt
A dose for fixed-dose multivitamin product
A dose for individual vitamins
A dose for insulin (if ordered)
A dose for other non-nutrient medications (if ordered)
    Performs clinical review of the PN order for:
Indication consistent with published guidelines or scientific literature
Appropriate dose of each macronutrient for the patient given indication, body weight, organ
function, and concurrent medications
Appropriate dose of each micronutrient for the patient given indication, body weight, organ
function, and concurrent medications
Appropriate osmolarity for route of administration
Changes from previous PN order
Any prescriber over-ride to alerts generated by clinical decision support within a CPOE system are
addressed
    Performs pharmaceutical review of the PN order for:
Compatibility of all ingredients at ordered doses and volume
Stability of the final PN admixture at ordered doses and volume
    Performs independent double-check for:
Transcription from PN order to pharmacy system
Transcription from PN order or pharmacy system to the ACD
Transcription of PN order to/from a pharmacy vendor
Any calculations or conversion of units-of-measure
Documents all steps as required for record keeping

Figure 1.  Parenteral Nutrition (PN) Order Review Competency Tool. ACD, automated compounding device; CPOE, computerized
physician order entry.
Boullata et al 553

Adult / Pediatric / Neonatal

(Circle applicable patient population)
Case #________
Pharmacist / Pharmacy Technician_____________________________________
Verified by____________________________________________________

Date Competency Competency Review Evaluator’s

Met Needed Initials
    Automated Compounding Device
Uses vendor-validated setup
Includes a second staff member for initial setup
• Uses independent double-check
• Uses printed check
• Verbally affirms all components including name, concentration, container size
Uses barcode technology to verify products during initial setup
Uses barcode technology to verify products during replacement of each ingredient
Traces tubing from the source container to the port attached to the ACD during initial setup
Traces tubing from the source container to the port attached to the ACD during replacement of each
source container
Requests independent pharmacist or supervisor verification when multiple source containers of a
single additive are used
Completely affixes patient-specific and auxiliary labels
Places completed PN in refrigeration prior to delivery
    Multi-chamber PN Product
Identifies the correct product and volume to meet the PN order
Inspects the product for any damage or deterioration prior to removing the overwrap
Completely activates and agitates the product to mix all components together
Able to identify inappropriate additives
Makes manual additives as ordered
Completely affixes patient-specific and auxiliary labels
Places completed PN in refrigeration prior to delivery
   Manual Compounding
Uses manual compounding technique when
• Ingredient volume is too small for ACD to measure accurately
• Interaction potential between ingredient and ACD component
• Chemical reaction potential cannot be mitigated by altering sequence of addition, or
• There is a shortage/outage of a PN component and conservation measures are in place
Requests independent pharmacist or supervisor verification for manually additives prior to adding to
the PN
    All PN Preparations
Environment for PN preparation complies with USP <797>
Verifies PN order
• After initial order entry
• Prior to injecting manual additive
• After compounding
Visually inspects PN prior to dispensing
Reviews and compares PN order, patient-specific PN label, and compounding formulation prior to
dispensing
Documents all steps as required for record keeping

Figure 2.  Parenteral Nutrition (PN) Compounding Competency Tool. ACD, automated compounding device; USP, United States
Pharmacopeia.

•• Pharmaceutical considerations for nutrition support
formulations
•• Nutrition support interventions for various disease
states and clinical conditions/settings, including
therapeutic goals
•• Documenting and tracking adverse drug reactions
and medication (including nutrient products) errors
4. The pharmacy technician should be certified and receive
in-depth training in PN preparation to include the
following:
554 Nutrition in Clinical Practice 31(4)
•• Proper personal hygiene and protective equipment
•• Cleaning of the ACD and compounding environment
•• Setup and verification of the ACD and individual
components
•• Review formulation, label, and select appropriate
bag
•• Scan and check barcodes, pump admixture, or acti-
vate multichamber bag
•• Be familiar with dosing differences between PN
components intended for neonatal, pediatric, and
adult patients, as institutionally appropriate
•• Verify ingredients, including those that require
manual admixture
•• Safely combine components of PN, including the
manual addition of ingredients
•• Affix patient-specific label, auxiliary labels
•• Store properly
•• Inventory management for individual PN components
5. Pharmacist shall review at least 10 PN orders for the
initial competency evaluation (via patient case scenar-
ios and/or actual patients) under the supervision of an
experienced pharmacy preceptor.
6. Pharmacist and pharmacy technician shall prepare at
least 10 PN orders for each patient population man-
aged by the organization (eg, adult, pediatric, or
neonate).
7. During evaluation of competency, the preceptor should
use the PN Order Review Competency Tool (Figure 1)
or the PN Preparation Competency Tool (Figure 2) as
appropriate.
8. For annual competency, completion of ongoing con-
tinuing education requirements on nutrition support
should be combined with the following:
•• PN order assessment of at least 2 cases or patients
reviewed using the PN Order Review Competency
Tool (Figure 1) or
•• PN preparation of at least 2 population-specific PN
orders using the PN Preparation Competency Tool
(Figure 2).
Conclusion
PN is a complex therapeutic modality reflected in complex
prescriptions with dozens of ingredients, each with clinical
rationales, dosing implications, and interaction potential. As
such, the pharmacist reviewing the PN order should demon-
strate competency to optimize the delivery of safe and effective
therapy. Additionally, the pharmacist and/or the pharmacy
technician preparing or directly supervising the preparation of
the PN should demonstrate competency to prepare an appropri-
ate and safe admixture for each patient. Institutions should
implement policies and procedures addressing determination
of competent PN order review and PN preparation. This should
be assessed initially and on an annual basis at a minimum. Any
identified medication errors related to PN order review or PN
preparation will necessitate more frequent competency assess-
ment—in addition to a systematic review of the PN use pro-
cess. The ASPEN model presented in this article can be used to
develop and implement such policies and procedures.
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