Standards for Specialized Nutrition Support: Home Care Patients

Abstract

The American Society for Parenteral and Enteral Nutrition (A.S.P.E.N.) is a professional society of physicians, nurses, dietitians, pharmacists, allied health professionals, and researchers dedicated to assuring that every patient receives optimal nutrition care. A.S.P.E.N.'s mission is to serve as the preeminent, interdisciplinary nutrition society dedicated to patient-centered, clinical practice worldwide through advocacy, education, and research in the field of specialized nutrition support. These Standards for Specialized Nutrition Support: Home Care Patients are an update of the 1999 standards. These standards present a range of performance of competent care based on expert clinical opinion that should be subscribed to by any home care provider caring for patients receiving home enteral or parenteral nutrition. A separate reference, “Guidelines for the Use of Parenteral and Enteral Nutrition in Adults and Pediatric Patients,”1 provides evidence-based practice guidelines that are coded to reflect the strength of evidence supporting the guideline to assist clinicians in their decision-making process in the development of nutrition care plans (NCP) for patients. Use of the word shall within this document indicates standards to be followed strictly to conform to the standard; use of 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. May is used to indicate a course of action that is permissible within the limits of recommended practice. A list of definitions is included in the last chapter of this standard to assist the reader in understanding terms used in this standard. The standards are presented in the most generic terms possible. The details of specific tests, therapies, and protocols are left to the discretion of individual home care providers. Each home care provider shall strive to provide the best nutrition support structure that is possible, given the resources of the organization. The standards aim to assure sound and efficient nutrition education and care for those patients in need of home enteral or PN. 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, reviewed, and approved by the A.S.P.E.N. Standards Committee and the A.S.P.E.N. Board of Directors. Interdisciplinary nutrition care planning shall be achieved through collaboration of the referring physician, home care provider, and nutrition support practitioner(s). 1.1. The role of each healthcare professional is clearly defined and responsibilities are designated.2–5 1.2. The physician who has expertise in home parenteral nutrition (PN) and enteral nutrition (EN) support or a physician who works with a multidisciplinary team primarily should be responsible for the patient's nutrition care. The physician should act in collaboration with a nurse,* dietitian,* pharmacist,* and other healthcare professionals as needed. Each healthcare professional shall demonstrate competency in nutrition support.2–5 1.3. Home PN and EN support shall be initiated, modified, supervised, evaluated, and coordinated by the referring physician, home care provider, and nutrition support practitioner(s). *Use of the titles nurse, dietitian, and pharmacist refers to registered nurse, registered dietitian, and registered pharmacist. The referring physician, home care provider, 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 PN and EN services, which shall include, but not be limited to the following: 2.2.1. The qualifications, roles, and responsibilities of the referring physician, home care provider, and nutrition support practitioner(s). 2.2.2. Ongoing competency assessment program for staff members. 2.2.3. Individuals authorized to prescribe home PN and EN therapies. 2.2.4. Criteria for patient eligibility and selection, including medical suitability, rehabilitative potential, home environment evaluation, social and economic constraints, educational abilities, and psychosocial factors. 2.2.5. A process for referral to a home care provider for provision of parenteral or enteral formulations, equipment, supplies, and nursing care. 2.2.6. Education, training, and evaluation of patient/caregiver competency. 2.2.7. A process for patient monitoring (eg, frequency of follow-up, nutrition assessment, laboratory studies, response to nutrition therapy, and physical examination). 2.2.8. A process for referral to consultative medical services, psychologists, social workers, community resources, and patient support groups, as appropriate. 2.2.9. Reimbursement processes for payment of services, equipment, and supplies. 2.2.10. Preparation, storage of, and techniques for administering PN or EN therapy in the home. 2.2.11. Equipment and maintenance tracking system. 2.2.12. Disposal of medical equipment and supplies. 2.2.13. Prevention, management, and timely response to complications in the home. 2.2.14. Emergency preparedness plan for the home care provider, and for patients and caregivers. 2.2.15. A process for timely communication and collaboration among the referring physician, home care provider, nutrition support practitioner(s), patient, caregiver, and other healthcare professionals involved. 2.2.16. Discharge-from-service criteria for termination of services. The patient/caregiver and all healthcare professionals involved in the care of the patient shall have access to a home care provider that provides 24-hour on-call services. The home care provider shall initiate and maintain a medical record for every patient receiving home PN or EN. 4.1. Confidentiality, sensitivity, and integrity of data and information will be maintained in compliance with the Health Insurance Portability and Accountability Act. 4.1.1. Names and contact information of caregivers who will assist in care of the patient should be documented. 4.2. Medical records shall include, but not be limited to, documentation of the following: 4.2.1. Consent for care. 4.2.2. A treatment plan signed by the physician including prescriptions for PN or EN therapies, medications, and orders for activity level, access-site care, and oral diet. 4.2.3. Contact information for the physician or other nutrition support practitioners shall be documented. 4.2.4. Functional status of the patient, permitted activities, psychosocial needs, suitability of home environment for nutrition therapy. 4.2.5. All pertinent patient diagnoses, prognosis, and short-term and long-term treatment objectives, and estimated duration of therapy. 4.2.6. Results of nutrition assessment and findings on physical examination. 4.2.7. Education and training of patient and/or caregivers, including competency evaluation. 4.2.8. A current medication profile, including prescription and nonprescription drugs, vitamin/mineral supplements, oral nutrition or herbal supplements, home remedies, known drug allergies or sensitivities, and history of tobacco use, alcohol, and illicit drug use. 4.2.9. Signed and dated progress notes for each contact between the home care provider and the patient, referring physician or nutrition support practitioner(s). Progress notes shall include significant changes to therapy or complications including the goals of therapy, and shall report response to nutrition therapy including but not limited to results of serial monitoring, revisions in the NCP, and patient compliance with procedures and techniques. 4.2.10. Documentation at termination of nutrition therapy should include but not be limited to the following: reason for terminating treatment, attainment of care plan goals, complications, patient outcome, and follow-up. Nutrition support is a high-risk, problem-prone treatment and shall be addressed in the home care provider's performance improvement and outcome measurement activities. 5.1. Data to be collected shall include but not be limited to mortality, hospital readmission, complications, customer satisfaction, and problem-reporting and resolution. 5.2. Outcomes shall be assessed in relation to internal or national benchmarks. 5.3. Sentinel events (rare but serious adverse outcomes) related to treatment shall be appropriately assessed and reported to appropriate regulatory agencies. Criteria shall be established for identification of patients who are nutritionally-at-risk by an initial screening mechanism.6–8 6.1. All patients admitted to the home care provider shall undergo nutrition screening using subjective and/or objective criteria within 72 hours of acceptance or on the initial home visit.9 6.2. The policy, procedure, and content of the nutrition screen shall be formalized and documented. 6.3. The result of the nutrition screen shall be documented. 6.4. Patients identified on initial screen as nutritionally-at-risk shall be referred to the physician for further orders regarding nutrition assessment and intervention. 6.5. Patients identified as not nutritionally-at-risk shall be rescreened at regularly specified intervals or when their clinical or nutrition status changes. All patients identified as nutritionally-at-risk by the patient screening mechanism or requiring home PN or EN shall have a nutrition assessment. The results of the nutrition assessment and recommendations should be shared with all patient care providers. 7.1. The nutrition assessment shall be performed by, or under the supervision of, a registered dietitian or healthcare professional with training and expertise in PN and EN within a time frame specified by organizational policy. 7.2. Subjective and objective assessment of the patient's current nutrition status and requirements shall occur.10 7.2.1. The subjective assessment of nutrition status should include a nutritionally focused history. Elements that should be documented as part of the subjective assessment include the following: recent changes in dietary intake (quantitative and qualitative); mastication, swallowing, gastrointestinal and elimination symptoms (including stomatitis, nausea, vomiting, diarrhea, constipation, and anorexia); functional and anatomic status of gastrointestinal tract, current status and recent changes in functional capacities (eg, ambulation, employment, recreation, endurance, mental status); psychosocial factors (eg, social support; eating disorders; language barriers; family dynamics; personal, ethnic, cultural, or religious dietary prescriptions; substance abuse; psychiatric disorders); socioeconomic factors (eg, personal financial situation); patient preferences and directives with regard to intensity and invasiveness of care; emotional response to current illness; admitting diagnosis; concurrent medical and surgical problems that may affect nutrition requirements; and nutrition support options, including medications, allergies (food, drug, or latex), and home remedies. 7.2.2. The objective assessment of nutrition status should include data obtained from the physical examination, anthropometric measurements, and laboratory data. Elements of the physical examination relevant to nutrition status should include loss of subcutaneous fat, muscle wasting, presence of edema, ascites, mucocutaneous lesions, hair and skin changes, presence of wounds, and patient specific indices as determined from the subjective portion of the nutrition assessment. Anthropometric data that shall be documented include height, length, head circumference (if applicable), altered height and weight relationship, current body weight, ideal body weight, usual body weight; recent change in weight (quantified), and body mass index. Laboratory data9 that should be reviewed and documented may include complete blood count with differential; serum electrolytes (including calcium, phosphorous, and magnesium), blood urea nitrogen, and creatinine; glucose; albumin; aspartate aminotransferase; alkaline phosphatase; total bilirubin; prothrombin time; international normalized ratio; and triglycerides. 7.3. If home PN or EN is indicated, 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. 7.3.1. 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 telephone. 7.3.2. The patient/caregiver shall be willing and able to perform home PN and EN therapy and associated procedures. 7.3.3. The patient/caregiver shall be able to troubleshoot minor problems or call for assistance when complications occur. 7.3.4. The patient/caregiver shall be informed and knowledgeable about the rationale, therapeutic goals and options, risks, benefits, and responsibilities (financial and otherwise) of home PN and EN and agree to participate. 7.4. Initiation of PN in the home setting shall only be considered in patients who are clinically stable, have an appropriate indication for PN, are able to be evaluated in the home, and are capable of being educated in the safe administration of the therapy. Initiating therapy at home shall be considered only when assessment confirms that the benefits greatly outweigh the risks. 7.4.1. Review of patient's medical and social history, age, laboratory data, and indication for PN shall occur. 7.4.2. Laboratory data shall be obtained within 48 hours prior to initiation of home PN.9 More frequent assessment of laboratory data may be required to ensure efficacy and prevent complications of nutrition support when initiated in the home. Laboratory data may need to be modified for pediatric patients. 7.4.3. High-risk patients who may not be candidates for the initiation of PN in the home setting include patients at risk for the refeeding syndrome; infants; IV drug abusers; and patients with diabetes, fluid and electrolyte/acid-base disorders, and major organ dysfunction. Patients with these conditions may need more frequent monitoring and clinical assessment than can be managed at home. 7.4.4. Once therapy is initiated, the patient/caregiver must be able to: recognize vascular access device (VAD) complications, including signs and symptoms of catheter-related infection; recognize signs and symptoms of fluid imbalance; perform fingerstick glucose or urine testing for glycosuria; recognize signs and symptoms of hyperglycemia or hypoglycemia; and troubleshoot pump malfunction or problems. 7.5. The results of the nutrition assessment shall be summarized and documented. 7.5.1. A classification system for nutrition risk according to the findings of the subjective and objective nutrition assessments shall be used. 7.5.2. Patient's nutrition requirements shall be summarized according to the findings of the subjective and objective nutrition assessments. The summary should include appropriate route of administration, fluid, protein and calorie requirements. The summary should also include electrolyte and micronutrient requirements. 7.6. Patients who are not considered candidates for home PN or EN shall be provided with alternative choices/settings for receiving nutrition support. The NCP shall be developed with an interdisciplinary approach involving the patient, the patient's referring physician, home care provider, and other healthcare professionals involved in the care of the patient as appropriate. 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, and patient education. The NCP shall address patient and family caregiver education about nutrition support therapy and involvement in decisions regarding goals of treatment. 10.1. The NCP shall include nutrition goals; route for administration; prescribed nutrients; infusion schedule; drug-nutrient interactions; specialized techniques of preparation and administration in the home setting; care of access device, equipment, solutions, and formulas; monitoring frequency; and a plan to implement if problems related to infusion access devices, equipment, or patient symptoms develop. Implementation should commence after assessment and development of an NCP. 11.1. Implementation of an NCP shall have a defined ordering process. 11.2. Verbal prescriptions/orders for PN or EN therapy shall be accepted only by personnel designated by the home care 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. 11.3. 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. The route selected to provide nutrition support shall be appropriate to the patient's medical problems, safety, efficacy, and patient preference. 12.1. When functional, the gastrointestinal tract is the preferred route for nutrition support and should be used to administer nutrition support. 12.2. PN should be provided only when the gastrointestinal tract is nonfunctional, cannot be accessed, or when oral nutrition or EN would exacerbate gastrointestinal tract dysfunction.1 12.3. Peripheral PN may be given through a peripheral-midline VAD and may be considered to provide nutrition support until central access is obtained. 12.4. 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. 12.5. Confirmation of VAD tip or enteral tube placement is obtained and documented in the patient's medical record prior to administration of therapy. 12.5.1. 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.1,11 12.6. Standard techniques and protocols shall be established for the proper care and management of the vascular and enteral access.11,12 PN formulations shall be prepared as prescribed, appropriate for the patient's disease process and compatible with route of access. 13.1. PN formulations shall be appropriate for the route of access. 13.2. PN formulations shall be adjusted as appropriate in patients with organ dysfunction. 13.3. PN formulations should be adjusted when significant amounts of nutrients are provided through means other than PN (eg, oral intake, IV fluids, medications using a lipid-based vehicle, peritoneal dialysis). 13.4. PN formulations shall be prepared using policies and procedures governing aseptic technique, manufacturing, compatibility, and stability.13,14 13.5. Automated compounding devices are recommended for the compounding of PN formulations. Personnel using automated compounding devices shall be trained and demonstrate competency. Training should 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 assure the quality of the preparation process to minimize the risk of contamination, especially by microorganisms. 13.5.1. PN formulations compounded by an automated compounding device shall be checked against the programmed admixture and weight of components. 13.5.2. The operator shall continuously monitor the automated compounding device during the preparation process to assure proper operation. 13.5.3. Demonstration of competency to safely operate the automated compounding device shall be assessed annually. 13.6. PN formulations shall be compounded under sterile conditions and shall comply with national standards.14,15 13.6.1. Aseptic technique shall be taught, used, and evaluated on a periodic basis. 13.6.2. PN admixtures shall be prepared in a class 100 laminar airflow hood using aseptic technique14,15 and under the direction of a pharmacist.16 13.6.3. The compounding room should be a controlled room with limited access to decrease the potential for contamination of sterile compounded products. 13.7. The final PN formulation shall be checked visually to assure appropriate volume, absence of particulate matter or phase separation in the IV fat emulsion (IVFE).13 13.8. All PN formulations shall be prepared in compatible containers and shall be administered through a filter. A 0.22-μm filter shall be used for 2-in-1 formulations. A 1.2-μm filter shall be used for total nutrient admixtures (TNAs). Alternatively, a 1.2-μm filter may be used for all PN formulations.13 13.9. Methods should be taken to limit the amount of aluminum contamination in PN formulations.17,18 PN formulations shall be visually inspected during preparation, prior to hanging, and during administration to identify potential incompatibilities of the formulation (ie, calcium/phosphate precipitation). PN formulations shall be labeled appropriately, including administration date and time and beyond-use date, in compliance with the A.S.P.E.N. Safe Practices Task Force for Parenteral Nutrition13,14 and any applicable state regulations. Labeling shall also include any special patient instructions (ie, additives, activation of dual chamber bags, and cycling schedule). Additives to PN formulations shall be appropriate and compatible with all ingredients. 15.1. All patients receiving PN should receive daily parenteral multivitamins in quantities established by the US Food and Drug Administration (FDA) Center for Drug Evaluation and Research.19,20 15.2. 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 care provider. Parenteral multivitamins should be added immediately before starting the PN infusion. 15.3. If parenteral iron is clinically indicated, it may be administered as various forms of IV iron. Only iron dextran can be added to a bag that does not contain IVFE. An iron dextran test dose is required before the initial infusion. The other choices for iron replacement require a separate infusion. 15.4. Any additions to a PN formulation by the patient or caregiver shall be approved by the home care provider. 15.5. The addition of concentrated electrolytes to PN formulations in the home setting should be avoided.21 15.6. Addition of electrolytes and medications to a PN formulation after administration has begun shall be avoided. 15.7. Healthcare professionals responsible for the preparation and delivery of PN formulations shall use methods for detection or prevention of formulation incompatibilities. 15.8. All patients receiving PN should receive daily parenteral trace elements. Dosing may need to be adjusted for severe renal and hepatic dysfunction, excessive losses, or in patients receiving long-term PN.1 15.9. The addition of calcium and phosphate to PN formulations should comply with guidelines13 in the literature and manufacturer's guidelines for automated compounding. 15.10. Use of calcium chloride shall be avoided due to greater risk of electrolyte and nutrient incompatibility. Calcium gluconate salt is the preferred choice when compounding PN formulations. 15.10.1. Calcium and phosphate salts should not be added in close sequence or consecutively to the PN formulation. 15.10.2. Phosphate should be added prior to the addition of calcium during the compounding process. 15.10.3. Some amino acid formulations contain phosphorus and must be accounted for in the calculation of calcium/phosphorus solubility. 15.11. Any additive lacking compatibility and stability data in standard reference sources should not be added to PN formulations. EN formulations shall be prepared as prescribed, appropriate for the patient's disease process and compatible with route of access. 16.1. EN formulations shall be prepared to prevent contamination. Commercially available EN formulations shall be used whenever possible. 16.2. EN formulations shall be prepared by the patient/caregiver who has been trained in accordance with policies and procedures and manufacturer's instructions. 16.3. EN formulation preparation equipment shall be routinely sanitized. EN formulations shall be appropriately packaged and labeled. 17.1. EN formulations shall be packaged in containers that can assure cleanliness during preparation, storage, and administration. 17.2. EN formulations shall be packaged in containers that assure cleanliness and accuracy of administration. Additives to EN formulations shall be safe, stable, and compatible with all ingredients. 18.1. Healthcare professionals responsible for the preparation and administration of EN formulations shall have resources available to document compatibility and stability of any additives. 18.1.1. Compatible medications should be administered individually in a manner to avoid tube occlusion and to attain desired therapeutic response. The tube should be flushed after administration of any medication. 18.1.2. Modular nutrition components can be added to EN formulas to increase calories, protein, or fiber as deemed appropriate by the patient's healthcare provider. They should be diluted as necessary to prevent occlusion of feeding apparatus. 18.2. Colorants (food coloring or methylene blue dye) should not be added to EN formulations.22,23 PN and EN formulations shall be stored and administered accurately in accordance with the prescribed therapeutic plan and consistent with the patient's tolerance. 19.1. PN formulations should be stored under refrigerated conditions (35.6°F–46.4°F) and warmed to room temperature prior to infusion.13,14 19.2. Temperature control during transport of sterile products for home use shall be maintained to ensure the stability and integrity of the products in accordance with manufacturer's recommendations or currently accepted standards. 19.3. Unopened and partially used commercially available EN products should be stored at temperatures as recommended by the manufacturer. 19.4. The use of home prepared or blenderized EN formulations requires additional attention to nutrient content and safe food handling and storage practices. They should be stored under refrigeration and discarded after 48 hours.24 19.5. Protocols shall be written regarding techniques used to administer EN and PN formulations. 19.5.1. Protocols shall be written to prevent enteral feeding tube or VAD occlusion. 19.5.2. A protocol shall be written to prevent infection due to the feeding formulation and the equipment used in its administration. 19.5.3. A protocol shall be written regarding the appropriate hang time for PN and EN formulations.25,26 19.5.3.1. Once started, the infusion of a PN formulation shall be completed within 24 hours or the remaining formulation shall be discarded.11 19.5.3.2. Infusion of IVFE as a separate infusion should be completed within 12 hours or discarded.25 19.5.4. A protocol should be written to prevent the inadvertent administration of EN formulation through a VAD.27 an 19.6. The nutrient infusion method and infusion control device selected for administration of PN or EN shall be suitable for home use. 19.7. Selection of the nutrient infusion method or infusion control device should be based on clinical need, safety, accuracy of delivery, and cost-effectiveness. 19.8. 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. 19.9. PN formulations shall be infused using a pump. 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, abilities, and readiness, as appropriate to the care and service provided. This competency and compliance is periodically assessed and documented. 20.1. The patient receiving home PN or caregiver should be instructed on the safe and effective use of PN formulations in accordance with legal requirements, including the following: 20.1.1. Name and telephone numbers of resources available 24-hours-a-day to troubleshoot and answer questions. 20.1.2. The name, composition, intended use, and expected outcome of the formulation. 20.1.3. Medication information and administration, including dosage, route, frequency, and the potential for adverse effects and drug interactions. 20.1.4. Inspection of home PN containers to assure that the PN bag is intact and there are no leaks. 20.1.5. Inspection of the contents before and after any additives are added to assure there are no precipitates, changes in color, or any disruption/destabilization in the TNA. 20.1.6. Instruction on the safe addition of any additives, including mixing and inspection of the final PN