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research-article2014

NCPXXX10.1177/0884533614539017Nutrition in Clinical PracticeDurfee et al

Standards of Practice

A.S.P.E.N. Standards for Nutrition Support: Home and Alternate Site Care

Nutrition in Clinical Practice Volume XX Number X Month 201X 1­–14 © 2014 American Society for Parenteral and Enteral Nutrition DOI: 10.1177/0884533614539017 ncp.sagepub.com hosted at online.sagepub.com

Sharon M. Durfee, RPh, BCNSP; Stephen C. Adams, MS, RPh, BCNSP; Elaine Arthur, RD, LD, LDN; Mandy L. Corrigan, MPH, RD, LD, CNSC; Kathleen Hammond, MS, RN, RD, LD; Debra S. Kovacevich, RN, MPH; Kevn McNamara, PharmD, CNSC; Jack A. Pasquale, MD; Home and Alternate Site Care Standards Task Force; American Society for Parenteral and Enteral Nutrition

Abstract The American Society for Parenteral and Enteral Nutrition (A.S.P.E.N.) is a professional society of physicians, nurses, dietitians, pharmacists, nurse practitioners, physician assistants, other allied health professionals, and researchers. A.S.P.E.N. envisions an environment in which every patient receives safe, efficacious, and high-quality nutrition care. A.S.P.E.N.’s mission is to improve patient care by advancing the science and practice of clinical nutrition and metabolism. These combined Standards for Nutrition Support: Home Care and Alternate Site Care are an update of the 2005 and 2006 standards. (Nutr Clin Pract. XXXX;xx:xx-xx)

Keywords nutritional support; standards of care; evidence-based practice; enteral nutrition; parenteral nutrition; home parenteral nutrition; nutritional assessment; long-term care

Introduction The American Society for Parenteral and Enteral Nutrition (A.S.P.E.N.) is a professional society of physicians, nurses, dietitians, pharmacists, nurse practitioners, physician assistants, other allied health professionals, and researchers. A.S.P.E.N. envisions an environment in which every patient receives safe, efficacious, and high-quality nutrition care. A.S.P.E.N.’s mission is to improve patient care by advancing the science and practice of clinical nutrition and metabolism. These combined Standards for Nutrition Support: Home Care and Alternate Site Care are an update of the 2005 and 2006 standards.1,2 A.S.P.E.N. defines standards as “benchmarks representing a range of performance of competent care that should be provided to assure safe and efficacious nutrition care.”3 Standards are documents that define the structure needed to provide competent care. Standards usually address professional responsibilities as they relate to patient assessment, diagnosis, education, care plan development, implementation, clinical monitoring, evaluation, and professional issues. A.S.P.E.N. publishes discipline-based (eg, dietitian, nurse, pharmacist, or physician) and practice-based (eg, adult hospitalized patients, pediatric hospitalized patients, home care, long-term care) standards. Standards are presented in the most generic terms possible. The details of specific tests, therapies, and protocols are left to the discretion of individual healthcare facilities. The standards aim to ensure sound and efficient nutrition care by homecare providers and in alternate site care facilities. The application of standards is always subject to the judgment of the professional as applied to the individual case.

Home care can be provided in the traditional home as well as a group home, intermediate care facility, or assisted living facility. Alternate site care facilities can include skilled nursing facilities (SNF), long-term acute care hospitals (LTACHs), or rehabilitation hospitals. Patients in these care settings include adult and pediatric age groups. Throughout this document, those receiving care will be referred to as patients, but they are also known as consumers or residents in this variety of care settings. Care may be provided by the patient themselves or by a nonprofessional caregiver in the home. This entity will be designated in this document as patient/caregiver.

1. Audience for Standards These practice-based standards are intended for use by healthcare professionals charged with the care of patients receiving nutrition support therapies in the home or alternate site care settings.

2. Level of Care These Standards of Practice present a range of performance of competent care that should be provided by healthcare Financial disclosure: None declared. Corresponding Author: Peggi Guenter, A.S.P.E.N., 8630 Fenton St. Suite 412 Silver Spring, MD 20910, USA. Email: [email protected]

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professionals caring for patients receiving nutrition support therapy in home and alternate site care settings. Terminologies included in each standard are specified as follows: a. Shall: Indicates standards to be followed strictly. b. Should: Indicates that among several possibilities, one is particularly suitable, without mentioning or excluding others, or that a certain course of action is preferred but not necessarily required. c. May: Indicates a course of action that is permissible within the limits of recommended practice. These standards do not constitute medical or other professional advice and should not be taken as such. To the extent that the information published herein may be used to assist in the care of patients, this is the result of the sole professional judgment of the attending healthcare professional whose judgment is the primary component of quality medical care. The information presented in these standards is not a substitute for the exercise of such judgment by the healthcare professional. These standards have been developed by the A.S.P.E.N. Home and Alternate Site Care Standards Task Force, reviewed by the A.S.P.E.N. Clinical Practice Committee, and approved by the A.S.P.E.N. Board of Directors. These Standards of Practice should be used in conjunction with the previously published A.S.P.E.N. Clinical Guidelines, Standards, Position Papers, and other Board-Approved documents, which can be accessed at the A.S.P.E.N. Documents Library, http://www .nutritioncare.org/Library.aspx.

CHAPTER I: Organization Standard 1. Interdisciplinary Nutrition Support Model of Care Interdisciplinary nutrition care planning shall be achieved through collaboration of the referring physician, home or alternate site care provider, care team members, and nutrition support practitioner(s). 1.1. The role of each healthcare professional is clearly defined and responsibilities are designated.4-7 1.2. The physician who has expertise in home parenteral nutrition (PN) and enteral nutrition (EN) support or a physician who works with an interdisciplinary team should be primarily responsible for the patient’s nutrition care. The physician should act in collaboration with a nurse*, dietitian*, pharmacist*, nurse practitioner, physician assistant, and/or other healthcare *Use of the titles of nurse, dietitians, and pharmacists refers to registered nurse, registered dietitian/registered dietitian nutritionist, and registered pharmacist.

professionals as needed. Each healthcare professional shall demonstrate competency in nutrition support as per his or her institutional site policy.4-7 1.3. Home and alternate site PN and EN support shall be initiated, modified, supervised, evaluated, and coordinated by the referring physician, home or alternate site provider, and nutrition support practitioner(s).

Standard 2. Policies and Procedures The referring physician, homecare or alternate site care providers, and nutrition support practitioner(s) managing care for a patient receiving home PN and EN shall be guided by policies, procedures, and other written processes. 2.1. Policies and procedures shall be appropriately developed, reviewed, revised, and dated to reflect optimal standards of care. 2.2. There shall be written policies and procedures concerning the scope and provision of home or alternate site care PN and EN services as per their institutional or agency policy, which shall include, but not be limited to: •• The qualifications, roles, and responsibilities of the referring physician, homecare provider, and nutrition support practitioner(s) •• Issues around informed consent •• Ongoing competency assessment program for staff members •• Individuals authorized to prescribe PN and EN therapies •• Criteria for patient eligibility and selection, including medical suitability, rehabilitative potential, home environment evaluation, social and economic constraints, educational abilities, and psychosocial factors •• A process for referral to a home care provider or alternate site to provide parenteral or enteral formulations, equipment, supplies, and nursing care •• Education, training, and evaluation of patient/caregiver competency •• A process for patient monitoring (eg, frequency of follow-up, nutrition assessment, laboratory studies, response to nutrition therapy, and physical examination) •• A process for referral to consultative medical services, psychologists, social workers, community resources, and patient support groups, as appropriate •• Reimbursement processes for payment of services, equipment, and supplies •• Preparation, storage of, and techniques for administering PN or EN therapy •• Equipment and maintenance tracking system

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•• Disposal of medical equipment and supplies •• Prevention, management, and timely response to complications •• Emergency preparedness plan for the home or alternate site care provider and for patients and caregivers •• A process for timely communication and collaboration among the referring physician, home or alternate site care provider, nutrition support practitioner(s), patient, caregiver, and other healthcare professionals involved •• Discharge criteria for discontinuation of services

Standard 3. Access to Care The patient/caregiver and all healthcare professionals involved in the care of the patient should have access to a home or alternate site care provider that provides 24-hour on-call services.

home remedies, known drug and nondrug allergies or sensitivities, and history of tobacco, alcohol, and illicit drug use •• Signed and dated progress notes for each contact between the home care provider and the patient, referring prescribers, and/or nutrition support practitioner(s) 4.3. Progress notes should include changes to therapy, complications, and goals of therapy and shall report response to nutrition therapy, including but not be limited to results of serial monitoring, revisions in the nutrition care plan, and patient adherence to procedures and techniques. 4.4. Documentation at completion of nutrition therapy should include but not be limited to the reason for discontinuation of treatment, status of care plan goals, complications, patient outcome, and follow-up.

CHAPTER II: Nutrition Care Process

Standard 4. Medical Record The home or alternate site care provider shall initiate and maintain a medical record for every patient receiving PN or EN in accordance with state and federal regulations. 4.1. Confidentiality, sensitivity, and integrity of data and information shall be maintained in compliance with the Health Insurance Portability and Accountability Act. 4.1.1. Names and contact information of patients, caregivers, and emergency contacts who will assist in care of the patient shall be documented. 4.2. Medical records should include but not be limited to documentation of: •• Consent for care •• A treatment plan signed by the appropriate prescriber, including prescriptions for PN or EN therapies, medications, orders for activity level, access-site care, laboratory tests, and oral diet, if appropriate •• Contact information for the prescriber or other nutrition support practitioners, home health agencies, and other care providers •• Functional status of the patient, permitted activities, psychosocial needs, and suitability of home environment for nutrition therapy •• All pertinent patient diagnoses, prognosis, shortterm and long-term treatment objectives, and estimated duration of therapy •• Results of nutrition assessment and findings on physical examination •• Education and training of patient and/or caregivers, including competency evaluation •• A current medication profile, including prescription and nonprescription drugs, vitamin/mineral supplements, oral nutrition or herbal supplements,

Standard 5. Nutrition Evaluation It is essential that clinicians increase their recognition of malnutrition through the use of appropriate screening and assessment methods.8-10 Nutrition evaluation includes the processes of nutrition screening and assessment, and in the alternate care setting, these two processes are often combined. Nutrition screening is most often completed upon admission, and for the patient at nutrition risk, a full nutrition assessment and development of the nutrition care plan is completed (see Figure 1). 5.1. Criteria shall be established for identification of patients who are nutritionally-at-risk by an initial screening mechanism, when appropriate.11-13 5.2. All patients admitted to a homecare provider or alternate site care facility should undergo nutrition evaluation using a standardized tool within a time frame specified by an organizational or regulatory body policy. 5.3. The policy, procedure, and content of the nutrition evaluation shall be formalized and documented. 5.4. The result of the nutrition evaluation should be documented in the medical record and communicated to the interdisciplinary team and appropriate interventions initiated within a time frame specified by an organizational or regulatory body policy. 5.5. Patients identified as nutritionally-at-risk shall be referred for further orders regarding nutrition assessment and intervention. 5.6. Homecare patients identified as not nutritionally-atrisk should be reevaluated at regularly specified intervals or when their clinical or nutrition status changes. 5.7. Alternate site care patients should be reevaluated within a time frame specified by an organizational or regulatory agency policy or earlier if a change in clinical status occurs.

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Nutrition in Clinical Practice XX(X) Not At Risk Admission

Yes Not At Risk

Paent Screening

Connued Care?

Discharge

Periodic Rescreening Paent Monitoring

Goals Achieved

At Risk

Paent Assessment

Development of Nutrion Care Plan

Implementaon of Nutrion Care Plan

Status

Paent Reassessment and Updang the Nutrion Care Plan

Terminaon of Therapy

Figure 1.  Nutrition care algorithm.12

Standard 6. Nutrition Assessment Nutrition assessment is defined as a comprehensive approach to diagnosing nutrition problems that uses a combination of the following: medical, nutrition, and medication histories; physical examination; anthropometric measurements; and laboratory data.1 Malnutrition shall be diagnosed using standardized criteria and an etiology-based nomenclature system.8-10 6.1. All patients identified as nutritionally-at-risk or requiring PN or EN shall have a nutrition assessment. The nutrition assessment shall be performed using a standardized tool by or under the supervision of a healthcare professional with training and expertise in PN and EN within a time frame specified by organizational or regulatory body policy. 6.2. Subjective and objective assessment of the patient’s current nutrition status and requirements shall occur.14 6.2.1.  The subjective assessment of nutrition status should include a nutritionally focused history. Elements that should be documented as part of the subjective assessment include: •• Recent changes in oral/enteral nutrition intake (quantitative and qualitative) •• Mastication, swallowing, gastrointestinal (GI), and elimination symptoms, including stomatitis, nausea, vomiting, diarrhea, constipation, and anorexia •• Cultural/ethnic food preferences •• Food and drug allergies/sensitivities/intolerances •• Current medication profile, including prescription and nonprescription drugs, vitamin/mineral supplements, oral nutrition or herbal supplements, home remedies, and history of tobacco, alcohol, and illicit drug use



•• Current status and recent changes in functional capacities (eg, ambulation, employment, recreation, energy, endurance, mental status, activities of daily living) •• Psychosocial factors (eg, social support, eating disorders; language barriers, family dynamics) •• Personal, ethnic, cultural, or religious dietary preferences or restrictions •• Socioeconomic factors (eg, personal financial situation, living environment) •• Patient preferences and directives with regard to intensity and invasiveness of care •• Emotional response to current illness or admitting diagnosis; pain; concurrent medical and surgical problems that may affect nutrition requirements and nutrition support options, including medications, allergies (food, drug, or latex), and home remedies 6.2.2.  The objective assessment of nutrition status should include data obtained from the medical records, physical examination (including nutrition-focused physical examination), anthropometric measurements, radiographic imaging studies, laboratory data, and intake and output records. Elements of the physical examination relevant to nutrition status should include: •• Oral and dental status •• Difficulty swallowing •• Loss of subcutaneous fat, muscle wasting •• Presence of edema, ascites •• Mucocutaneous lesions, hair and skin changes •• Altered skin integrity, including risk or presence of decubitus ulcers or wounds, grip strength, and patient-specific indices as determined from the subjective portion of the nutrition assessment

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•• Other factors, including function and anatomic configuration of the GI tract and admitting diagnosis or diagnoses •• Comorbidities and other medical/surgical history that may affect the absorption/digestion or requirements for nutrition support therapy or anatomic availability for enteral or vascular access •• Allergies and/or intolerances (food, medication, latex) and patient-specific indices determined from the subjective portion of the nutrition assessment 6.2.3. Anthropometric data that should be documented include measured height/length, head circumference (if applicable), altered height and weight relationship, current body weight, ideal body weight, and usual body weight; recent change in weight (quantified: measures in the past 30 days, 5% weight change in the past 30 days, weight change of 10% or more in the past 6 months); and body mass index.15 6.2.4. Laboratory data that should be reviewed and documented may include but are not limited to complete blood count with differential; serum electrolytes, (calcium, phosphorus, potassium, sodium, and magnesium), serum urea nitrogen, and creatinine; acid-base balance (serum chloride and carbon dioxide concentrations); glucose; alanine aminotransferase and aspartate transaminase; alkaline phosphatase; total bilirubin; and triglycerides.16,17 Micronutrient and trace element laboratory assays should be recommended if a deficiency or excess is suspected or requires monitoring with nutrition support therapy. 6.2.5. Patient preferences and advance directives with regard to intensity and invasiveness of care should be assessed as they may influence administration of nutrition support therapy. 6.3. For patients who are receiving nutrition support therapy in an alternate care facility, the nutrition assessment shall include indication of medical necessity for nutrition support therapy, any energy range requirements, medical necessity for disease-specific formulas/modulars, or medical necessity for delivery of enteral formulation via a pump.18 6.4. If PN or EN is to be administered in the patient’s home environment, medical suitability, rehabilitative potential, educational level or learning ability, and reimbursement sources shall be assessed by the physician, case manager, and/or other designated healthcare professionals to determine the availability of appropriate resources prior to initiation. Therapy should be clinically appropriate and include any medical/nutrition justification for disease-specific EN formula/modulars, justification for EN and/or PN energy provisions, or

medical necessity for delivery of EN or PN via a pump may be required by the payers. 6.4.1. The patient’s home shall be determined appropriate for the administration of home PN or EN support (eg, the patient should have a clean environment, sanitary water supply, electricity, refrigeration, adequate storage space for supplies, and access to a working telephone). 6.4.2. The patient/caregiver shall be willing and able to perform home PN and EN therapy and associated procedures. 6.4.2.1. For home PN and EN, patient/caregiver must be able to recognize access device complications, including signs and symptoms of catheter-related infection and occlusion, hyperglycemia, hypoglycemia, or fluid imbalance; perform fingerstick glucose or urine testing for glucosuria; and troubleshoot pump for malfunctions or problems. 6.4.2.2.  If the patient is not considered an appropriate candidate or patient/caregiver is not willing or able to manage PN or EN, the patient may require alternative therapy or care settings. 6.4.3. The patient/caregiver shall be able to troubleshoot minor problems or call for assistance when complications occur. 6.4.4. The patient/caregiver shall be informed and knowledgeable about the rationale, therapeutic goals and options, risks, benefits, and responsibilities (care, financial, and other) of home PN and EN and agree to participate. 6.4.5.  The patient/caregiver shall have the right to communicate with the managing provider, physician, or the physician’s designee on the management of the PN or EN. 6.5. Initiation of EN or PN in the home setting may be considered in patients who are clinically stable, have an appropriate indication for EN or PN, are able to be evaluated in the home, have home nursing care available, and be capable of being educated in the safe administration of the therapy. Initiating therapy at home shall be considered only when assessment confirms the benefits greatly outweigh the risks. 6.5.1. Review of patient’s medical and social history, age, laboratory data, and indication for EN/PN shall occur. 6.5.2. Laboratory data should be obtained prior to initiating home EN or PN. More frequent assessment of laboratory data may be required to promote efficacy and prevent complications of nutrition support when initiated in the home. Laboratory data may need to be modified for pediatric patients.

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6.5.3. High-risk patients who may not be candidates for initiating EN or PN in the home setting include patients at risk for refeeding syndrome, infants, patients with diabetes mellitus, fluid and electrolyte/acid-base disorders, or major organ dysfunction. Patients with these conditions may need more frequent monitoring and clinical assessment than can be managed at home. 6.6. The results of the nutrition assessment shall be summarized and documented. 6.6.1. A classification system for nutrition risk based on the findings of the subjective and objective nutrition assessments should be used. Etiologybased diagnosis of malnutrition should be used and documented.8-10 6.6.2. Patient’s nutrition requirements shall be summarized based on the findings of the subjective and objective nutrition assessments. The summary should include appropriate route of administration and fluid, protein, energy, electrolyte, mineral, and micronutrient requirements. 6.6.3. Frequent reassessment should occur per institution policies or sooner with a change in clinical condition. 6.6.4.  The nutrition assessment for both long-term care or homecare patients receiving nutrition support therapy shall include the indication of medical necessity for nutrition support therapy.

CHAPTER III: Development of a Nutrition Care Plan Standard 7. Interdisciplinary Approach The nutrition care plan shall be developed with an interdisciplinary approach involving the patient, caregivers and/or family, the patient’s referring physician, healthcare providers, and other healthcare professionals involved in the care of the patient, as appropriate. For long-term care: the nutrition care plan is developed based on information from the nutrition assessment and the Resident Assessment Instrument (RAI). The nutrition care plan should be completed within 7 days of admission or per institutional policy, after the completion of the RAI, and incorporated into the resident’s plan of care.

Standard 8. Goals and Expectations The nutrition care plan shall address patient/caregiver (or appropriate decision maker as designated by the law of the state) education about nutrition support therapy and involvement in decisions regarding goals of treatment. 8.1. The nutrition care plan shall include nutrition goals, route for administration, nutrient prescription, infusion

schedule, drug-nutrient interactions, and specialized techniques of preparation and administration in the homecare or alternate site setting. It should also address the care of access device, infusion equipment and formulations, the monitoring frequency, and a plan to implement if problems related to infusion access device, equipment, or adverse patient events develop. 8.2. A procedure for regular reevaluation of the care plan and patient/caregiver’s education goals should be implemented by the homecare or long-term care provider no later than intervals of every 3 months or as needed due to changes in patient status.

Standard 9. Objectives The objective(s) of nutrition care shall be determined and documented. This should include immediate and long-term goals of nutrition therapy, anticipated duration of therapy, patient education and the possible/potential end point of therapy (transition to oral/enteral diet with subsequent discontinuation of EN/PN), surgery alleviating the need for nutrition support therapy, resolution of medical problem resolving the need for that therapy, or lifelong nutrition support therapy.

CHAPTER IV: Implementation and Education Standard 10. Ordering Process Implementation should commence following assessment and development of the nutrition care plan. 10.1. Implementation of the nutrition care plan shall have a defined ordering process. 10.2. In specific circumstances when the clinician needs to clarify an order, verbal prescriptions/orders for PN or EN therapy shall be accepted only by personnel designated by the home or alternate care site provider and authenticated by the prescribing/ordering practitioner within a defined time period or as required under applicable law and/or regulations. All verbal prescriptions or orders should be read back to the prescribing/ordering practitioner. 10.3. Prescriptions/orders for PN or EN therapy shall be maintained in the patient’s medical record or received as required by law and regulation before any therapy is administered.

Standard 11. Nutrition Support Access The route selected to provide nutrition support therapy shall be appropriate to the patient’s medical problems, safety, efficacy, and patient preference.

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11.1. When functional, the GI tract is the preferred route for nutrition support therapy and should be used to administer nutrition support therapy. 11.2. PN should be provided only when the GI tract is nonfunctional, cannot be accessed, or when oral or EN would exacerbate GI tract dysfunction.19 11.3. Appropriate access shall be established by a healthcare professional who is skilled and competent with the insertion of the device in accordance with state law and regulation. 11.4. Confirmation of the proper placement of the vascular access device (VAD) or enteral access device is obtained and documented in the patient’s medical record prior to administration of nutrition support therapy. 11.4.1.  Central venous access shall be used for administration of central PN. The catheter tip should be positioned in the superior vena cava or adjacent to the right atrium.20 11.5. Standard techniques and protocols shall be established for the proper care and management of the vascular and enteral access device and site.20,21 11.6.  The Institute for Healthcare Improvement (IHI) Central Line Bundle should be used for central vascular access devices in the home and alternate care setting. This bundle is a group of evidence-based interventions for patients with intravascular central catheters that, when implemented together, result in better outcomes than when implemented individually. The key components of the IHI Central Line Bundle are: •• Hand hygiene •• Maximal barrier precautions upon insertion •• Chlorhexidine skin antisepsis •• Optimal catheter site selection, with avoidance of the femoral vein for central venous access in adult patients •• Daily review of line necessity with prompt removal of unnecessary lines22-24 11.7. Complications related to an access device and outcome of actions to manage the complication shall be clearly documented in the medical record.4 11.8. Patients who develop access complications shall be reassessed for appropriate device care technique. 11.9. Home PN patients with recurrent catheter-related bloodstream infection (CRBSI) despite adherence to aseptic technique should be considered for the use of prophylactic antimicrobial or ethanol lock solutions.25 11.10. Vascular access devices and enteral access devices that are occluded, malpositioned, leaking, or deteriorated should be evaluated and treated appropriately using care protocols.

Standard 12. PN Formulation Selection and Preparation PN formulations shall be prepared as prescribed, appropriate for the patient’s disease process and compatible with route of access. Organizations preparing PN solutions shall comply with USP General Chapter Pharmaceutical Compounding-Sterile Preparations. Outsourcing should be considered as an alternative to in-house compounding when the healthcare organization does not possess the technological resources or staffing to prepare PN admixtures according to USP Chapter .26,27 Standardized, commercially available PN products may be viable options to manually compounded sterile PN products when compliance with USP Chapter and accepted guidelines from patient safety organizations is not feasible.26,28 12.1. Organizations should develop a drug conservation policy that addresses the handling and disposition of PN components (while maintaining their integrity and sterility) that may be in short supply due to market conditions. 12.1.1. Organizations should access the A.S.P.E.N. website for recommendations for management of shortages of PN components (www. nutritioncare.org/drugshortages). 12.2. PN formulations shall be adjusted as appropriate in patients with organ dysfunction. 12.3. PN formulations should be adjusted when significant amounts of nutrients are provided through means other than the PN (eg, oral intake, enteral nutrition, intravenous [IV] fluids, and medications using a lipid-based vehicle, peritoneal dialysis). 12.4. PN formulations shall be prepared using policies and procedures governing aseptic technique, manufacturing, compatibility, and stability.26,29,30 12.5. Automated compounding devices (ACDs) should be used for the compounding of PN formulations. Personnel using ACDs shall be trained and demonstrate competency. Training shall include education on operation, aseptic technique, appropriate sequencing of additives, periodic calibration, troubleshooting, and maintenance of the device. Procedures shall be developed and followed to promote the quality of the preparation process to minimize the risk of contamination, especially by microorganisms.31 12.5.1.  PN formulations compounded by an ACD shall be checked against the programmed admixture and weight of components. 12.5.2. The operator shall continuously monitor the ACD during the preparation process to optimize proper operation. 12.5.3. Demonstration of competency to safely operate the ACD shall be assessed at least annually.

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12.5.4.  Organizations should allow manual-only additions of low-volume ingredients (eg, trace elements) or as part of conservation efforts during shortages of PN components. 12.5.5.  Verification of manual additives should include inspection of the actual vials and syringes that contain the additives. Proxy methods of verification (eg, syringe pullback) should not be used.28 12.6. PN formulations shall be compounded under sterile conditions and shall comply with national standards.26,30 12.6.1. Aseptic technique shall be taught, used, and evaluated on a routine basis. 12.6.2. PN admixtures shall be prepared in an ISO 5 clean area (either bench or laminar air flow hood) per USP Chapter using aseptic technique and under the direction of a registered pharmacist.26,30,31 12.6.3.  Compounding shall occur in a controlled environment to decrease the potential for contamination of compounded sterile products. 12.7. All patients receiving PN should receive daily parenteral trace elements unless receiving adequate trace element doses from other sources and the patient has adequate GI absorptive capacity. Dosing may require adjustment in renal and hepatic dysfunction, significant losses, or in patients receiving long-term PN.19 12.8. The addition of calcium and phosphate to PN formulations should comply with guidelines in the scientific literature as well as manufacturers’ guidelines for automated compounding.26,29 12.9. Calcium gluconate is the preferred source of calcium when compounding PN formulations. Use of calcium chloride should be avoided due to greater risk of electrolyte and nutrient incompatibility. 12.9.1. Calcium and phosphate shall not be added in close sequence or consecutively to the PN formulation. 12.9.2. Some amino acid products contain phosphate, which shall be accounted for in the calculation of calcium phosphate solubility. 12.10. PN formulations shall be visually inspected during preparation, prior to hanging, and during administration to identify potential incompatibilities of the formulation (eg, calcium phosphate precipitation).26 12.11. All PN formulations shall be prepared in compatible containers and shall be administered through a filter. A 0.22-micron filter should be used for dextrose– amino acids formulations. A 1.2-micron filter shall be used for total nutrient admixtures (TNAs). Alternatively, a 1.2-micron filter may be used for all PN formulations.26

12.12. Safeguards should be taken to limit the amount of aluminum contamination in PN formulations.32 12.13. The IV administration set should only be attached to the PN bag just prior to use.

Standard 13. Packaging and Labeling PN Formulations 13.1. PN admixtures shall be labeled appropriately, including rate and duration of infusion, components of the formulation, and beyond-use date in compliance with the USP , A.S.P.E.N. PN safe practice documents, and any applicable state regulations.26,29,30 13.2. Labels for home PN formulations should be consistent with USP General Chapter .33 13.2.1. Prescription labels should be organized in a patient-centered manner, organized in a manner that best reflects how most patients seek out and understand medical information and includes only the most important patient information needed for safe and effective understanding. 13.2.2. The labels should emphasize instructions and other information important to the patient by prominently displaying information that is critical for the patient’s safe and effective use of therapy, at the top of the label, specifying the patient’s name, drug name (spelling out full generic and brand name), and strength/ dose. Include explicitly clear directions for use in simple language, and directions should follow a standard format so the patient can expect that each element will be in the same regimented order each time the medication is received. 13.2.3.  Labels should use simple language and explicit instructions. Language on the label should be clear, simplified, concise, and familiar and should be used in a standardized manner. Only simplified common terms and standardized sentences developed to promote ease of understanding should be used. 13.2.4. The label should give explicit instructions, not using alphabetic characters for numbers. It should use standardized directions, listing which PN ingredients must be added by the patient/caregiver. Ambiguous directions such as “take as directed” should be avoided unless clear and unambiguous supplemental instructions and counseling are provided. 13.2.5. The label should include purpose for use of PN using clear, simple terms such as “for nutrition supplementation” or “to provide nutrition.”

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13.2.6. The labels should limit auxiliary information. Auxiliary information should be evidence based in simple, explicit language that is minimized to avoid distracting patients with nonessential information. Information should be presented in a standardized manner and critical for patient understanding and safe medication use. Use only icons for which adequate evidence suggests improved patient understanding about correct use of the medication. 13.2.7.  Labels should address limited English proficiency. •• Whenever possible, the directions for use should be provided in the patient’s preferred language to help prevent medication errors. •• Whenever possible, the directions for use should also appear in English to facilitate counseling. •• Medication names shall be in English so that emergency personnel and other intermediaries can have quick access to the information. •• Translations of prescription labels should be produced using a high-quality translation process. 13.2.8. Labels should be designed and formatted so that they improve readability and optimize typography using: •• High-contrast print •• Simple uncondensed familiar fonts with space within letters and between letters •• Sentence case with initial capital followed by lowercase words •• Large font size for critical information •• Adequate white space between lines of text •• White space to distinguish sections on the label such as directions for use vs pharmacy information •• Horizontal text only •• Never truncate or abbreviate critical information •• Highlighting, bolding, and other typographical cues should preserve readability and should emphasize patient-centric information or information that facilitates adherence •• Limit the number of colors used for highlighting •• Address visual impairment

Standard 14. Additives to PN Formulations Additives to PN formulations shall be appropriate and compatible with all ingredients. For management of additives in shortage, refer to standard 12.1. 14.1. All patients receiving PN should receive daily parenteral multivitamins in quantities established by the Food and Drug Administration (FDA) Center for Drug Evaluation and Research unless receiving adequate doses via another route.34,35

14.2. All additions to a PN formulation, such as multivitamins, shall be made by the patient or caregiver in a designated clean area as instructed by the home/alternate site care provider. Parenteral multivitamins shall be added immediately before starting the PN infusion. 14.3. If parenteral iron is clinically indicated, it may be administered as various forms of IV iron. Alternate forms of IV iron are available and shall be administered as a separate infusion. Only iron dextran can be added to a container of PN that does not contain an intravenous fat emulsion (IVFE). An iron dextran test dose is required before the initial infusion. 14.4. Only limited additions to a PN formulation should be made outside of the compounding pharmacy. Those components should be added by trained clinicians or patient/caregivers. Additions should be made just prior to administration. 14.5. The addition of concentrated electrolytes to PN formulations in the home and alternate care site setting shall be avoided.36 14.6. Addition of electrolytes and medications to a PN formulation after administration has begun shall be avoided. 14.7. Healthcare professionals responsible for the preparation and delivery of PN formulations shall employ methods for the detection or prevention of formulation incompatibilities. 14.8. Any additive lacking compatibility and stability data in standard reference sources should not be added to PN formulations.

Standard 15. EN Formulation Selection and Preparation EN formulations shall be prepared as prescribed, appropriate for the patient’s age, disease process, and compatible with route of access. 15.1. EN formulations shall be prepared to prevent contamination. Commercially available EN formulations shall be used whenever possible.21 15.2. For home EN, formulas shall be prepared by the patient/caregiver who has been trained in accordance with policies and procedures and the manufacturer’s instructions.21 15.3.  EN formulation preparation equipment, such as blenders, shall be routinely sanitized.

Standard 16. EN Formulation Packaging and Labeling EN formulations shall be appropriately packaged and labeled.

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16.1. EN formulations shall be packaged in containers, which can optimize maintenance of cleanliness during preparation, storage, and administration. 16.2. EN formulations shall be packaged in containers that promote accuracy of administration.

Standard 17. Additives to EN Formulations Additives to EN formulations shall be safe, stable, and compatible with all ingredients. 17.1. Healthcare professionals responsible for the preparation and administration of EN formulations shall have resources available to document compatibility and stability of any additives. 17.1.1. Compatible medications should be administered individually in a manner to avoid tube occlusion and to attain desired therapeutic response. 17.1.2.  Tubes should be flushed before and after administration of any medication with 15 mL of water unless the patient requires fluid restriction.21 17.1.3. Modular nutrition components may be prescribed in addition to EN formulas to increase energy, protein, or fiber as deemed appropriate by the patient’s healthcare provider. They should be dissolved and given separately to prevent occlusion of the enteral access device. 17.2.  Colorants (food coloring or methylene blue dye) shall not be added to EN formulations.21

Standard 18. Storage and Administration of PN and EN Formulations PN and EN formulations shall be stored and administered accurately in accordance with the prescribed therapeutic plan and consistent with the patient’s tolerance.21,37 18.1. PN formulations should be stored under refrigerated conditions (35.6–46.4°F) and warmed to room temperature prior to infusion.20 18.2. Temperature control during transport of sterile products for home and alternate care use shall be maintained to enhance the stability and integrity of the products in accordance with th manufacturer’s recommendations or currently accepted standards. 18.3. Unopened and partially used commercially available EN products should be stored at temperatures as recommended by the manufacturer. 18.4. The use of home blenderized or reconstituted powdered EN formulas requires additional attention to safe food handling and storage practices. They should be stored under refrigeration and discarded after 24 hours or per the manufacturer’s guidelines.21

18.5. Protocols shall be written regarding techniques used to administer EN and PN formulations. 18.5.1. Protocols shall be written to prevent enteral feeding tube or VAD occlusion. 18.5.2. A protocol shall be written to prevent infection due to the feeding formulation and the equipment used in its administration. 18.5.3.  A protocol shall be written regarding the appropriate hang time for PN and EN formulations.21,38 18.5.3.1. Once started, the infusion of a PN formulation shall be completed within 24 hours or the remaining formulation shall be discarded.26 18.5.3.2.  Infusion of IVFE as a separate infusion should be completed within 12 hours or discarded.26 18.5.4. A protocol should be written and safe equipment purchased to prevent the inadvertent administration of an EN formulation through a VAD.39 18.6. The nutrient infusion method and infusion control device selected for administration of PN or EN shall be suitable for home use. 18.7. Selection of the nutrient infusion method or infusion control device should be based on clinical need, safety, accuracy of delivery, and cost-effectiveness. An interdisciplinary process should be employed for selecting and evaluating equipment and technologic aids, such as smart pumps and barcoding, to reduce errors in PN administration. 18.8. Consideration should be given to patient preference, volume to be infused, type of regimen (cyclic, continuous, or intermittent), activity level of the patient, reimbursement issues, and ability/education level of patient and caregiver. 18.9. PN formulations shall be infused using a pump.

Standard 19. Patient/Caregiver Education on Home PN Administration There should be active communication with all member of the healthcare team to transition from one setting to another. The patient/caregiver shall receive education by qualified members of the healthcare team and demonstrate competence in the preparation and administration of home PN. The education and training are specific to the patient’s assessed needs, best methods of learning, abilities, and readiness, as appropriate to the care and service provided. This competency and compliance is periodically assessed and documented. 19.1. The patient or his or her caregiver should be instructed on the safe and effective administration of PN formulations in accordance with legal and regulatory requirements, including the following:

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•• Name and phone numbers of resources available 24 hours a day to troubleshoot and answer questions •• The name, composition, intended use, and expected outcome of the formulation •• Medication information and administration, including dosage, route, frequency, duration, and the potential for adverse effects and drug interactions •• Inspection of label prior to administration to ensure the prescribed PN formulation is given to the appropriate patient •• Inspection of home PN containers to check that the PN bag is intact and there are no leaks •• Inspection of the contents before and after any additives are added to assess that there are no precipitates, changes in color, or any disruption/ destabilization in the TNA •• Instruction on the safe addition of any additives, including mixing and inspection of the final PN formulations. Only specifically prescribed medications should be added to the PN to prevent nutrient-drug interactions. •• Connecting and disconnecting the IV administration tubing to the VAD by tracing the tubing back to the VAD •• Pre and/or postinfusion flushing to maintain VAD patency and prevent drug-nutrient incompatibility •• Proper VAD and site care •• Infection control and prevention, including aseptic technique required for any admixture procedures and administration via VAD, appropriate hand-washing techniques, and standard infection control practices •• Verification of proper pump programming each time a new volume and/or infusion time is ordered for the PN. A new PN pump and program instructions should be sent to the patient with each change in volume and/or cycle. If urgent changes are needed, and if the patient/caregiver is capable, reprogramming may be done in the home with professional instruction. •• Compatibility and stability of PN and coadministered fluids or medications under refrigeration or at room temperature •• Techniques for self-monitoring and identification of potential complications of therapy •• Proper storage of the PN container and identification of the “do not use after” or “beyond use date” on the label of the PN container •• Use and storage of infusion pump and supplies, including cleaning, disinfecting, emergency backup, safety, and troubleshooting •• Proper disposal of used containers, tubing, needles, and unused or outdated PN and/or medications

•• Action to be taken in the event of late or missed administration of PN •• Process to order additional PN, patient additives, or supplies •• Basic home safety (fire, electrical, environment, mobility, bathroom) •• Information on emergency preparedness to assist patients and caregivers if an emergency interrupts service •• Patients and caregivers shall be educated based on the teach-back method.40 •• Patients and caregivers shall display competency in the understanding and performance of techniques.

Standard 20. Patient/Caregiver Education on Home EN Administration The inpatient or homecare clinician shall instruct the patient receiving home EN or caregiver on the safe and effective use of EN in accordance with legal requirements and patient needs. The educational materials should include the following: •• Name and phone numbers of resources available 24 hours a day to troubleshoot and answer questions •• The name, composition, intended use, and expected outcome from the formulation •• Medication information and administration, including dosage, route, frequency, and the potential for adverse effects and drug interactions •• Timing, method of administration, and feeding schedule •• The route of administration and duration of nutrition therapy •• Care of the enteral access device and site •• Product hang time and stability at room temperature •• Inspection of enteral products for contents and expiration date •• Clean technique for preparation of EN, administration, and reuse of supplies and equipment •• Techniques for self-monitoring of therapy and identification of potential complications •• Proper storage of ready-to-use products and EN formulas that require mixing •• Use and storage of enteral feeding equipment, supplies, and pump (including safety, cleaning, disinfecting, emergency backup, and troubleshooting) •• Proper disposal of used containers, tubing, and unused or expired feeding formulations and/or medications •• Action to be taken in the event of late or missed administration of EN •• Process to order additional feeding formulation and supplies •• Infection prevention and control (ie, standard precautions)

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•• Basic home safety (fire, electrical, environment, mobility, bathroom) •• Information on emergency preparedness to assist patients and caregivers if an emergency should interrupt service •• Patients and caregivers shall be educated based on the teach-back method.37 •• Patients and caregivers shall display competency in the understanding and performance of techniques.

CHAPTER V: Patient Monitoring Standard 21. Parameters and Frequency Patient monitoring shall be designed to determine the effectiveness and appropriateness of nutrition support therapy. The process of patient monitoring must ensure that the nutrition goals are achieved. The monitoring process is also intended to reduce the risk of complications due to nutrition support therapy. Each patient’s nutrition status is monitored and documented on a regular basis. 21.1. The referring physician, care provider, and nutrition support practitioner(s) should monitor the clinical status and response to nutrition therapy. This shall include but not be limited to the following: •• Observation for signs and symptoms of intolerance to therapy •• Evaluation of weight changes and/or growth rates as appropriate •• Evaluation of hydration status •• Review of systems and/or physical examination •• Periodic review of biochemical, vitamin, mineral, or other pertinent laboratory data •• Assessment for clinical signs of nutrient deficiencies or excesses •• Assessment of other disease states or conditions that may affect the nutrition therapy •• Review for evidence of an interaction between the nutrition therapy and medications or other disease states •• Evaluation of functional status and performance •• Psychosocial status •• Evaluation of access device and site •• Patient compliance with techniques and procedures of the nutrition therapy and inventory of formulations 21.2. Review the appropriateness of the nutrition therapy, therapeutic regimen, and route of administration. This shall include but not be limited to: •• Assessment of the impact of the current medication regimen on the nutrition support therapy •• Assessment of the need for continued nutrition support therapy

•• Periodic review of the psychosocial status (patient and/or caregiver) and patient’s home environment •• Monitoring of fluid, nutrient, and oral intake •• Monitoring of urine, stool, and other GI losses or output •• Review appropriateness of the route of administration 21.3. PN or EN should be modified or discontinued when indicated based on the severity or magnitude of associated complications. 21.3.1.  Protocols shall be developed to identify mechanical, metabolic, and infectious complications necessitating interruption of nutrition support. 21.4. Results of the patient monitoring process should be documented and communicated to the physician and other healthcare professionals involved in the patient’s care.

CHAPTER VI: Review and Revision of Nutrition Care Plan Standard 22. Evaluation of Nutrition Care Plan The nutrition care plan is reviewed and revised as necessary. 22.1. The PN and EN treatment and care plan shall be reviewed, evaluated, and updated by the referring physician, homecare provider/alternate site provider, and other healthcare professionals to determine overall appropriateness, effectiveness, and safety of the treatment. 22.2. Patients shall be reassessed to determine the effectiveness of care in meeting therapeutic goals. Revision of the nutrition care plan may be required when changes occur in a patient’s clinical condition, response to therapy, environment or psychosocial status, drugs/ therapy, or when nutrition goals are not met. 22.3. All revisions of the nutrition care plan shall be documented in the patient’s medical record. 22.4. The route of nutrition support shall be periodically reassessed for adequacy, appropriateness, efficacy, and safety.

CHAPTER VII: Transition and Termination of Therapy Standard 23. Transition Feeding 23.1. During the transition from PN to EN, or PN to oral intake, or EN to oral intake, the patient shall demonstrate tolerance to the final nutrition support therapy.

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23.2. Adequate nutrients from oral intake should be demonstrated prior to discontinuing PN and/or EN. 23.2.1. Oral nutrient intake should be documented. 23.2.2. When appropriate, PN or EN should be gradually decreased as oral intake increases so that overall adequate nutrient intake is sustained. 23.2.3. If oral nutrient intake is suboptimal, PN or EN should not be discontinued. 23.2.4. Use of a speech therapist should be considered to assist as appropriate. 23.3. Written and/or verbal information should be given to the patient/caregiver if follow-up nutrition care is indicated.

Standard 24. Termination of Therapy 24.1. PN or EN should be terminated when the patient no longer benefits from therapy or the risks outweigh the benefits.41 24.2.  Patients and/or their designated representative, according to patients’ decisional capacity, shall be involved in decisions regarding the withdrawal of nutrition support. 24.3. Protocols shall exist to permit the discontinuation of PN and EN in accordance with patient advance directives, medical ethics, local practice standards, and current local, state, and federal law. To the extent possible, decisions regarding artificial nutrition and hydration should be based on evidence-based medicine, best practices, and clinical experience and judgment in discussion with the patient, family, or significant others.

Standard 25. Reimbursement 25.1. A process shall be in place to verify insurance benefits for medically ordered enteral or parenteral formulations, supplies, and services. 25.2. The medical record shall be complete to meet the criteria for insurance carriers, including both government payer and private pay companies. Appropriate authorization where required by payer shall be obtained prior to provision of services. 25.3. A communication process shall be in place to explain benefits and cost of services to the patient and caregiver. 25.4. A system shall be in place to procure payment for out-of-pocket expenses for medically ordered enteral and parenteral formulations, supplies, and services.

Standard 26. Performance Improvement Nutrition support is a complex therapy and shall be addressed in the homecare or alternate care provider’s performance

improvement and outcome measurement activities with the goal to improve the quality of nutrition support therapy. 26.1. Data to be collected should include but not be limited to mortality, all hospital readmissions, complications, customer satisfaction, and problem-reporting and resolution. 26.2. Outcomes should be assessed in relation to internal or national benchmarks. A.S.P.E.N.’s National Patient Registry for Nutrition Care, Sustain, is one example of a national registry tracking clinical outcomes in patients receiving PN in the homecare setting. This registry allows for institutional benchmarking by comparison to aggregate data and to measure outcomes nationally.42 26.3.  Adverse outcomes related to treatment shall be appropriately assessed and reported to regulatory agencies. 26.4. Home and alternate site care providers shall routinely assess data, communicate, and develop improvement programs with key stakeholders (clinicians, administrators, payers, quality improvement and safety officers, equipment vendors, education staff, outsourced pharmacies, patient advocates, delivery personnel, etc) that may influence outcomes. The data should be used to initiate new policies, procedures, and education to improve the delivery, safety, and efficacy of nutrition support therapy.

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C, Durfee SM, Holcombe BJ, Kochevar M, Nyffeler MS, Mirtallo J. Standards of practice for nutrition support pharmacists. Nutr Clin Pract. 2008;23:189-194. 7. Mascarenhas MR, August DA, DeLegge MH, et al. Standards of practice for nutrition support physicians. Nutr Clin Pract. 2012;27:295-299. 8. White JV, Guenter P, Jensen GL, Malone A, Schofield M. Consensus statement: Academy of Nutrition and Dietetics and the American Society for Parenteral and Enteral Nutrition: characteristics recommended for the identification and documentation of adult malnutrition (undernutrition). JPEN J Parenter Enteral Nutr. 2012;36:275-283. 9. Jensen GL, Hsiao PY, Wheeler D. Adult nutrition assessment tutorial. JPEN J Parenter Enteral Nutr. 2012;36:267-274. 10. Mehta NM, Corkins MR, Lyman B, et al. Defining pediatric malnutrition: a paradigm shift toward etiology-related definitions. JPEN J Parenter Enteral Nutr. 2013;37:460-481. 11. Kovacevich DS, Boney AR, Braunschweig CL, et al. Nutrition risk classification: a reproducible and valid tool for nurses. Nutr Clin Pract. 1997;12:20-25. 12. Mueller C, Compher C, Druyan ME; A.S.P.E.N. Board of Directors. A.S.P.E.N. clinical guidelines—nutrition screening, assessment and intervention in adults. JPEN J Parenter Enteral Nutr. 2011;35:16-24. 13. Arrowsmith H. A critical evaluation of the use of nutrition screening tools by nurses. Br J Nurs. 1999;12:1483-1490. 14. Detsky AS, McLaughlin JR, Baker JP, et al. What is subjective global assessment of nutritional status? JPEN J Parenter Enteral Nutr. 1987;11:8-13. 15. Centers for Medicare & Medicaid Services. National care determination (NCD) for enteral and parenteral nutrition therapy. http://www.cms. gov/medicare-coverage-database/details/ncd-details.aspx?NCDId=242& ncdver=1&DocID=180.2&SearchType=Advanced&bc=IAAAABAAA AAA& 1984. Accessed March 8, 2014. 16. Mirtallo J. Overview of parenteral nutrition. In Mueller CM, ed. The A.S.P.E.N. Adult Nutrition Support Core Curriculum. 2nd ed. Silver Spring, MD: A.S.P.E.N.; 2012. 17. Boullata J, Nieman Carney L, Guenter P. Administration and monitoring of enteral nutrition. In: A.S.P.E.N. Enteral Nutrition Handbook. Silver Spring, MD: A.S.P.E.N.; 2010. 18. DMERC Supplier Manual. Baltimore, MD: Centers for Medicare and Medicaid Services; 2004. 19. A.S.P.E.N. Board of Directors and the Clinical Guidelines Task Force. Guidelines for the use of parenteral and enteral nutrition in adult and pediatric patients [published correction appears in JPEN J Parenter Enteral Nutr. 2002;26:144]. JPEN J Parenter Enteral Nutr. 2002;26(suppl 1): 1SA-138SA. 20. Infusion Nurses Society. Infusion nursing: standards of practice. J Infus Nurs. 2011;34:S1-S110. 21. Enteral Nutrition Practice Recommendations Task Force: Bankhead R, Boullata J, Brantley S, et al. Enteral nutrition practice recommendations. JPEN J Parenter Enteral Nutr. 2009;33:122-167. 22. Pronovost P, Needham D, Berenholtz S, et al. An intervention to decrease catheter-related bloodstream infections in the ICU. N Emgl J Med. 2006;355(26):2725-2732. 23. Institute for Healthcare Improvement. Implement the IHI central line bundle. 2014. http://www.ihi.org/resources/Pages/Changes/Implement theCentralLineBundle.aspx. Accessed April 16, 2014. 24. Rinke ML, Bundy DG, Milstone AM, et al. Bringing central line–associated bloodstream infection prevention home: CLABSI definitions and prevention policies in home health care agencies. Jt Comm J Qual Patient Saf. 2013;39(8):361-370.

25. Oliveira C, Nasr A, Brindle M, Wales PW. Ethanol locks to prevent catheter-related bloodstream infections in parenteral nutrition: a meta-analysis. Pediatrics. 2012;129(2):318-329. 26. Ayers P, Adams, Boullata J, et al. A.S.P.E.N. parenteral nutrition safety consensus recommendations. JPEN J Parenter Enteral Nutr. 2014;38: 296-333. 27. American Society of Health-System Pharmacists. ASHP guidelines on outsourcing pharmaceutical services. Am J Health Syst Pharm. 1998;55:1611-1617. 28. Rich DS, Fricker MP, Cohen MR, Levine SR. Guidelines for the safe preparation of sterile compounds: results of the ISMP sterile preparation compounding safety summit of October 2011. Hosp Pharm. 2013;48: 282-294, 301. 29. Boullata JI, Gilbert K, Sacks G, et al. A.S.P.E.N. clinical guidelines: parenteral nutrition ordering, order review, compounding, labeling, and dispensing. JPEN J Parenter Enteral Nutr. 2014;38:334-377. 30. United States Pharmacopeia. USP Chapter ; Pharmaceutical Compounding—Sterile Preparations. Rockville, MD: United States Pharmacopeial Convention; 2006. 31. American Society of Health-System Pharmacists. ASHP guidelines on the safe use of automated compounding devices for the preparation of parenteral nutrition admixtures. Am J Health Syst Pharm. 2000;57: 1343-1348. 32. A.S.P.E.N. Aluminum Task Force and A.S.P.E.N. Board of Directors. A.S.P.E.N. statement on aluminum in parenteral nutrition solutions. Nutr Clin Pract. 2004;19:416-417. 33. United States Pharmacopeia. USP General Chapter Prescription Container Labeling. Rockville, MD: United States Pharmacopeial Convention; 2012. 34. Parenteral multivitamin products; drugs for human use; drug efficacy study implementation; amendment (21CFR 5.70). Fed Regist. 2001;65: 21200-21201. 35. Greene HL, Hambidge KM, Schanler R, Tsang RC. Guidelines for the use of vitamins, trace elements, calcium, magnesium, and phosphorous in infants and children receiving total parenteral nutrition: report of the Subcommittee on Pediatric Parenteral Nutrient Requirements from the Committee on Clinical Practice Issues of the American Society for Clinical Nutrition. Am J Clin Nutr. 1988;48:1324-1342. 36. Fatal potassium errors linked to pharmacy processes. ISMP Medication Safety Alert. 2004;9:2-4. 37. American Society of Health-System Pharmacists (ASHP). Best Practices for Hospital & Health-System Pharmacy 2013-2014. Bethesda, MD: ASHP; 2013:443-457. 38. O’Grady NP, Alexander M, Burns LA, et al. Guidelines for the prevention of intravascular catheter-related infections. Am J Infect Control. 2011;9(4) (suppl):S1-S34. 39. Simmons D, Symes L, Guenter P, Graves K. Tubing misconnections: normalization of deviance. Nutr Clin Pract. 2011;26:286-293. 40. Kornburger C, Gibson C, Sadowski S, Maletta K, Klingbeil C. Using “teach-back” to promote a safe transition from hospital to home: an evidence-based approach to improving the discharge process. J Pediatr Nurs. 2013;28:282-291. 41. A.S.P.E.N. Ethics Position Paper Task Force: Barrocas A, Geppert C, Durfee SM, et al. A.S.P.E.N. ethics position paper. Nutr Clin Pract. 2010;25:672-679. 42. Guenter P, Robinson L, DiMaria-Ghalili RA, Lyman B, Steiger E, Winkler MF. Development of Sustain: A.S.P.E.N.’s national patient registry for nutrition care. JPEN J Parenter Enteral Nutr. 2012;36: 399-406.

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