ORIGINALES

 

Development of the management for parenteral nutrition traceability in a standard hospital

Desarrollo de la gestión de la trazabilidad de la nutrición parenteral en un hospital tipo

 

 

Beatriz Bernabéu Soria¹, Máxima Mateo García², Carmina Wanden-Berghe², Mercedes Cervera Peris³, Guadalupe Piñeiro Corrales⁴ and Javier Sanz-Valero¹

¹Universidad Miguel Hernández, Sant Joan d'Alacant.
²Hospital General Universitario, Alicante.
³Hospital Universitario son Espases, Palma.
⁴Estructura Organizativa Gestión Integrada, Vigo. Spain.

This paper was awarded a grant by the Instituto de Salud Carlos III of Madrid, Spain, through the Health Research Project with reference PI13/00464, and cofunding by the European Fund for Regional Development, "A Way of Shaping Europe".

Correspondence

 

 

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ABSTRACT

Objective: to develop the traceability control and the hazard analysis in the processes of parenteral nutrients (PN).
Method: a standardized graphical notation was generated, describing in detail each of the stages in the overall process. The presence of hazards was analysed by sequencing decisions. The existence of Control Points (CP) or Critical Control Points (CCP) was estimated by Criticality Index (CI) for each hazard taking into account the probability of occurrence and the severity of the damage. The threshold for the IC was set in 6.
Results: a specific flow chart for the management and traceability of PN was obtained, defining each of the stages in CPs (validation and transcription of the prescription and administration) or CCPs (preparation, storage and infusion pump -flow and filter-). Stages regarding the delivery, the recovery and the recycle of the packing material of PNs are not considered CPs and, therefore, they were not included in the dashboard.
Conclusions: PN must be dealt with in the frame of a standardized management system in order to improve patient safety, clinical relevance, maximize resource efficiency and minimize procedural issues. The proposed system provides a global management model whose steps are fully defined, allowing monitoring and verification of PN. It would be convenient to make use of a software application to support the monitoring of the traceability management and to store the historical records in order to evaluate the system.

Key words: Parenteral nutrition; Quality control; Process assessment; Information management.

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RESUMEN

Objetivo: desarrollar el control de la trazabilidad y el análisis de riesgos en el proceso de mezcla de nutrientes parenterales (NP).
Método: se diseñó la notación gráfica normalizada, caracterizando cada una de las etapas dentro del proceso global. Se analizó la presencia de riesgos mediante la secuenciación de decisiones. La existencia de Puntos de Control (PC) o de Puntos Críticos de Control (PCC) se calculó mediante el Índice de Criticidad (IC) para cada uno de los riesgos, teniendo en cuenta la probabilidad del suceso y la gravedad de los daños. El punto de corte del IC se estableció en 6.
Resultados: se obtuvo el diagrama de flujo específico para la gestión y trazabilidad de la NP, caracterizándose cada una de las etapas en PC (validación y transcripción de la prescripción y administración) o PCC (preparación, conservación y bomba de infusión -flujo y filtro-). Las etapas de entrega de la NP y de recuperación y reciclado del material de envasado no se consideraron PC y, en consecuencia, no fueron incluidos en el cuadro de gestión.
Conclusiones: la NP debe integrarse en un sistema normalizado de gestión con el fin de mejorar la seguridad del paciente y la pertinencia clínica, maximizar la eficiencia de los recursos y minimizar los incidentes procesales. El sistema propuesto permite establecer una gestión global cuyas etapas quedan totalmente caracterizadas, permitiendo su control y verificación. Sería deseable disponer de una aplicación informática que facilitara el seguimiento de la gestión de la trazabilidad y tener un histórico de los registros que permita evaluar el sistema.

Palabras clave: Nutrición parenteral; Control de calidad; Evaluación del proceso; Gestión de la información.

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Contribution to Scientific Literature

The high complexity of parenteral nutrition (PN), the wide range of professionals involved, and the likelihood of errors with severe damage to patients have led to the preparation of clinical practice guidelines and recommendations for action targeted to promoting quality and reducing the risk of damage caused by this type of treatment. Therefore, the need to control the PN process and confirm that it is conducted with complete safety leads to the essential need for a traceability plan and a procedure for evaluation of the self-monitoring system, based on the Critical Control Points and Hazard Analysis, in order to fully meet these requirements; but at the same time, for those others which will also be necessary in order to verify the adequate vigilance of the system, to verify its adequate functioning, and to ensure the complete guarantee of patient safety.

This study intends to establish a system to monitor traceability and hazard analysis in the process of preparation, storage, distribution and administration of parenteral nutrition, describing all its stages, and defining those points of control existing in the process.

 

Introduction

Parenteral nutrition (PN) will provide patients those basic nutrients they require through intravenous administration, and it is used when a person must resort to alternative methods that will allow them to receive those nutrients required in order to live, when unable to eat because the gastrointestinal tract function is not functioning. The substances administered must provide the energy required and the complete essential nutrients, and they must be harmless and adequate for their metabolism. They are prepared in adequate facilities, usually in the Hospital Pharmacy Unit; all handling must be conducted within a laminar flow cabinet under strict asepsis techniques to ensure a sterile preparation.

These may contain over 50 components with a high potential for chemical and physical-chemical interactions between their ingredients, the bag, the oxygen, temperature and light. These interactions are potentially iatrogenic, and in some cases might even compromise patients' lives¹. The management of the nutritional support has been classified as one of the five strategies with very high impact regarding pharmacotherapeutical safety in patients².

It is logical to monitor that all operations are conducted as planned, and to have all the documentation required in order to conduct a comprehensive evaluation of the preparation process. But current control systems are retrospective, and it is not possible to prevent certain shortcomings in the process, though this is useful in order to identify points with likelihood of error and, therefore, with room for improvement. The possibility to avoid, or at least to prevent, the potential complications and risks in PN, would represent a significant improvement for patient safety.

PN is administered in different care settings, from Intensive Care Units to patients' own homes. This home PN, as well as any other treatment administered out of hospital, requires a careful planning of the strategy including intervention, monitoring and follow-up³. To this aim, the NADYA - SENPE Group created in 1994 a registry of patients with home PN in Spain, which allows to have an approximate knowledge of this nutrition in real life^4,5. There is no system implemented to control risks during transportation of the PN to patients' homes and its storage.

The healthcare setting has experienced major changes during recent years; current management systems prioritize healthcare directed towards total quality and the elimination or correction of any practices which are not safe for patients. Among these, medication errors must be mentioned as a potential source of damage; therefore, different organizations are devoted to promote a safe use of medications⁶. Regarding nutritional support, any error will be highly important because, even though these are not very frequent, the probability of causing severe damage to the patient is very superior to that of any other type of medication⁷.

Law 29/2006, of July, 26th, about guarantees and rational use of medication and healthcare products, mentions medication traceability in its article 87, with the aim to ensure and reinforce their safety⁸. Likewise, the Guideline for Good Practices regarding the preparation of medications in Hospital Pharmacy Units states the importance of guaranteeing the traceability of the preparation process of a medication⁹. Therefore, it is essential to have a transparent, reliable and dynamic system, which will allow healthcare authorities to react in a fast and adequate manner when any quality or safety risks of medications are detected. Thus, the system to be implemented must be certain to determine which products are part of its composition, and who are its providers (backward traceability), the follow-up of products at the time of preparation (internal or process traceability), regardless of whether they are prepared or not at the Hospital Pharmacy Unit, and the tracking of nutrition once prepared and distributed, both to the different hospital wards and through the home hospitalization units (forward traceability). That is to say, the objective is to link the products used in preparation, the operations or processes followed by these (equipment, lines, chambers, mixing, division...) and the final products obtained, their storage, distribution and administration.

Therefore, a perfect system of traceability must be available, to guarantee at all times the identification of any person involved in any stage of the process, or any substance incorporated into the parenteral nutrition.

According to the Codex Alimentarius Commission, "traceability is the ability to follow the movement of a food through specified stage(s) of production, processing and distribution"¹⁰.

In order to implement traceability procedures, besides the relevant regulations, it must be taken into account that the appropriate documentation must always be attached to products⁹. Both requirements imply the identification of products managed throughout the process^1,11.

It is worth highlighting that a traceability system does not need to be complicated; the best traceability system is the one which fits with the usual working methods and allows to record the information required, which then can be accessed in a fast and dynamic manner.

According to the International Organization for Standardization, standardization or normalization is an activity with the objective to determine, when faced with real or potential problems, those regulations for common and repeated use, with the aim to obtain a system of optimal level. In this setting, professional practice standards represent the procedure considered as reference by experts; though this doesn't make them inflexible rules, and they don't represent enforced practice requirements.

It has been demonstrated that the implementation of systematized procedures for achieving an improvement in the quality of the prescription-preparation-storage-dispensing-administration process (from here on, the Process), is completely associated with a more efficient use of those resources available, therefore achieving the adaptation to current quality demands in our setting, and complying with all current legislation regarding its preparation and control^12,13. Achieving an adequate certification of quality allows to establish a normalized system with processes perfectly described and documented, thus achieving the traceability and supervision of the stages¹⁴. However, it is necessary to be able to assess the system taking into account the accuracy of the information stored and time of response, which must be the minimum possible, because there might be risks for people's health¹⁵.

Consequently, the objective of these studies would be to develop traceability control and hazard risks within the process of preparation, storage, distribution and administration of parenteral nutrition products, describing all stages of traceability for PN (flow charts) and defining those Critical Control Points (CCPs) existing in the Process.

 

Materials and Methodology

Design

Three processes were designed through the standard graphical notation Business Process Modelling Notation (BPMN), to represent the operational management of the different processes in the PN logistical chain (Figure 1):

 

 

- Preparation Process (Pp)

- Process for internal patients (Pip)

- Process for external patients (Pep)

This management model allowed to analyze and describe each one of the steps within the Process, thus facilitating their individual analysis and the determination and control of any potential risks: Critical Control Points (CCPs). Besides, this methodology allows processes to be easily escalated (broadened) if it became necessary at some point, allowing efficiency and efficacy when faced with any change or new requirement.

A complete management of the traceability of each one of the sub-processes was conducted, preparing BPMN diagrams of their different units for each one of them.

All this process was based upon compliance with the 2008 Spanish Consensus for Preparation of Parenteral Nutrients, in the Guidelines for Correct Manufacturing in the European Union: Annex 1, Manufacturing of Sterile Medications by the Spanish Agency for Medicines and Medical Devices, and the Good Practice Guidelines for Preparation of Medications in Hospital Pharmacy Units.

Stages and Control of Traceability

• Development of general and specific flow diagrams that will ensure the stages of prescription validation / transcription, preparation, storage, distribution and administration, allowing its verification at any point (Figure 2). This item was formalized through a consensus by experts including the pharmacists from the Pharmacy Unit in the Hospital General Universitario de Alicante, Hospital Universitario Son Espases de Palma de Mallorca, and Complejo Hospitalario Universitario de Vigo, and by the physician from the Home Hospitalization Unit of the Hospital General Universitario de Alicante.

 

 

• Adoption of controls that will confirm the connection between the flow diagram and all the stages which form the PN Process.

Based on the preparation of the flow diagrams and management charts, documented procedures are established in order to identify the addition of any substance that will be incorporated to a PN (backward traceability), and in all cases, the connection with the clinical prescription that initiates the process.

Additionally, a documented procedure will be established in order to know at all times which PN has been supplied and to whom (forward traceability), linking all products involved in the preparation process with the resulting PN (process traceability).

Hazard Analysis and Critical Control Points

Management Charts were prepared, containing the identification of the significant dangers at each stage, determining the control measures appropriate for each danger, determining the Critical Control Points (CCPs) and the sequencing of decisions for CCP identification (Figure 3).

 

 

Each stage where a control measure can be applied, and which is essential in order to prevent or eliminate any danger associated with the innocuousness of the PN, or to reduce it to an acceptable level, requires the following variables for the definition of each CCP:

• Presence (existence of danger).

• PN incorporation or contamination.

• Danger generation or increase in the PN.

• Survival (persistence of danger).

The variables for the management of the process control are:

• Stage: Each process existing in the final flow diagram in the System of Traceability Management.

• Probability of the event (P): Variable for calculation of the Criticality Index.

• Severity of damage (S): Variable for calculation of the Criticality Index.

• Criticality Index (CI): Result of the P x S calculation.

• Each one of the steps in the decision tree: S1, S2, S3 and S4.

• Control Point (CP): Stage decided to be controlled, even though its Criticality Index is not superior to 6.

• Control Critical Point (CCP): Stage of enforced control, because its Criticality Index is superior to 6.

• Control Measure: Measure in order to control each one of the Critical Points studied.

Calculation of the Criticality Index for each of the CCPs

The criterion to evaluate each danger identified was determined according to the criteria established by the International Featured Standards (IFS). The following were taken into account:

• Probability of the event (P): This was quantified by the historic record of events and non-conformities, according to a consensus by experts. Once this historic record is available, it will be classified into:

- Low: No events or non-conformity during the past 2 years (value equal to 1).

- Medium: 1 or 2 events or non-conformities during the past year (value equal to 3).

- High: More than twice during the past year (value equal to 5).

• Severity of damage (S):

- Low: It causes moderate or low damage, but no adverse effects on health (value equal to 1).

- Medium: It causes severe or chronic damage, as well as mild adverse effects on health and/or it could be severe if there was exposure to danger during long periods of time (value equal to 3).

- High: The existence of danger can cause adverse effects in at least part of the population and/or become a threat to life (value equal to 6).

The Criticality Index is the value obtained from the calculation between the probability of the event and the severity of damage.

CI = P x S

Once applied this equation, any results over 6 indicated that this potential CCP should be submitted to decision sequencing for CCP identification (IFS Decision Tree, figure 3), and it was determined whether the measure of control on the cause of danger was a CCP or a Control Point (CP).

In any case, when danger had a high severity (value equal to 6), it was at least considered as a Control Point.

Those dangers with a control measure not considered as a CCP, but as a CP, were equally identified in the control chart, and must also be submitted to vigilance, indicating the measures to be adopted in order to ensure that the CP is under vigilance.

Variables of Identification

Each PN unit will have the information to identify it unequivocally (identifying at least the variables stated in the Annex II of the R.D. draft, which regulates the traceability of medications for human use). Therefore, the variables for identifying each unit in the traceability process are the national code (if any), PN unit code, expiry date, lot identification code, and free code (for future use).

 

Results

Based on the consensus by experts stated in figure 2 of the System for Traceability Management, the Global System is obtained (Figure 4). In this figure, all stages that form the procedure for traceability management are described, which allows their follow-up and reproducibility.

 

 

After analyzing the different stages of the process of NP preparation/distribution, dangers were identified with their relevant probability and severity, in order to analyze them subsequently through the IFS Decision Tree (Figure 3), and this is shown in the Management Chart (Table 1).

 

 

Through calculating the Criticality Index corresponding to each stage of the System for Traceability Management, it was possible to obtain both Control Points and Critical Control Points (Table 1).

It must be taken into account, according to the methodology applied, that in order to submit stages to the Decision Tree sequencing, the Criticality Index should be superior to 6.

It was not considered appropriate to classify as CCPs the prescription validation and transcription stages, considering that the Pharmacy Units of the three hospitals of reference for this study conduct these stages through a computer program depending on external companies. Even so, it was decided to include them in the Management Chart as CPs:

• Prescription Validation: There is a low probability of error, but the severity of the event would be reckoned as maximum, with a Criticality Index 6 (1 x 6). This stage must be conducted by a pharmacist from the parenteral nutrition area.

• Prescription Transcription: Data for calculating the Criticality Index were equal to those in the Validation Stage (1 x 6 = 6). Anyway, it is advised that a pharmacist other than the one conducting the validation should conduct this control.

The CCPs detected were:

• Preparation: There is a high probability that this stage is not adequately conducted, and the severity of the damages caused if this happened would also be high, with a Criticality Index 30. The Control Measures that should be taken are: process automation, so that human error would be minimal, or conducting a dual verification to ensure that it has been conducted adequately. Besides, gravimetric controls should be conducted to confirm that weight and volume are correct, and microbiological controls to ratify that there is no microbial growth in the PN. It could be interesting to conduct test controls in the final preparation for certain critical ions (for example, potassium), particularly in paediatric PNs (the addition of new controls would mean the process re-evaluation).

• Storage: The probability of any problem in this stage was considered medium, while the severity of damages it could cause was defined as high, obtaining a Criticality Index 18. This is a CCP both in the hospital and in the community settings. The measure of control put forward was the control of parameters of the fridge / refrigerator, because the most important thing in this stage is that the temperature is adequate, because otherwise there could be microbial growth which would turn the PN useless.

• Pump: This stage was sub-divided into two phases:

a. Infusion: There is a high probability of an inadequate setting up of the device, and the severity of damages caused by this would also be high; therefore, this leads to a Criticality Index 30. The measure of control is an adequate selection of the volume and time of infusion, so that the rate will be as indicated, and no problem will be caused to the patient.

b. Filter: Both the probability and the severity were considered within medium values, Criticality Index equal to 9. The measure of control would be the verification of the existence and integrity of the filter.

The stages of NP delivery and recovery and recycling of bags (packaging) obtained a score equal to 3; therefore, these were not considered Control Points, and consequently were not included in the Management Chart.

Summing up, and in order to conduct an adequate vigilance and verification of Control Points, and particularly of Critical Control Points, it is recommended to prepare a verification list in order to record and document all controls to be conducted. It would be highly recommendable to have a software application which not only allowed this control, but also provided a historic record of those actions conducted.

 

Discussion

The procedure recommended won't replace current legislation, though it has been designed in order to improve the control of management and traceability of the PN process to benefit patient care, thus ensuring safety, continuity, and adherence.

The activities for quality management, its measurement and improvement, must be considered as one of the most important strategic lines to be developed in healthcare centres^16,17, including hospital pharmacy units^18,19.

With the implementation of traceability management, a standard system is set up with perfectly described and documented processes, facilitating its follow-up and optimizing the supervision of all its stages. Besides, these are completely compatible with the quality rules derived from ISO-9000²⁰, given that this model promotes management by processes in order to improve the circuits and quality of final products²¹.

In Parenteral Nutrition (PN), the guarantee of quality is based on the fact that all operations will be conducted according to plan, and having all the necessary documentation to allow its evaluation¹; for this aim, it is good to have standards for the stages of preparation, dispensing and control²². Thus, a system of management by processes, applied to parenteral nutrition, will guarantee quality and safety, achieving the traceability and supervision of all stages.

A Pharmacy Unit adequate for manufacturing medications, in this case PN, is achieved through a quality system designed, planned, implemented, sustained and subject to continuous improvement, allowing an uniform release of medications with the appropriate quality attributes²³. Protocols for PN are a wide concept which should be extended to all stages forming the process of the specialized nutritional support²⁴.

Regarding the stages of PN delivery and recovery and recycling of bags (packaging), these were not considered as Control Points in the results; however, this doesn't prevent them from being also integrated within the management system, should it be convenient. This would promote the record of all stages, and at the same time would allow to close the traceability circuit. Moreover, it would allow to know if these processes have been controlled, both from the point of view of the availability of the patient, particularly in home hospitalization, as well as from the healthcare and environmental importance entailed by an adequate disposal of medication rests and packaging.

The validation of the prescription and its transcription are very important in terms of the correct preparation of the PN: however, the probability of errors has been significantly reduced with the use of computer programs. Besides making mathematical calculations, these programs feature warnings that help to verify the stability of the preparation, to detect potential incompatibilities between its components, to watch for potential deviations from clinical recommendations, and to comply with the safety limits that will facilitate the pharmaceutical validation process¹. The assisted electronic prescription integrated with the management systems in the PN area has demonstrated a reduction in the potential errors made, and an increase in the quality of the whole process^25,26. It would be adequate to be able to generate a process for information exchange between the prescription program and the system for traceability management, that would allow to achieve an integrated overall process.

When managing the preparation stage, the addition of different products was estimated as a first measure of control, always taking into account the automation of this stage through computer procedures, which has been previously mentioned. The double checking list (or check control) must be used as long as there is no alternative computer system. However, one of the strategies established for vigilance of the quality of the product prepared is the gravimetric control, which consists in comparing the real weight of the product with that calculated according to the volume and density of each of its components^1,27. Pérez Serrano and cols.²⁸ pointed out that establishing a routine gravimetric control was a useful, easy and fast strategy, which could help to guarantee the quality of PN preparation, not finding any statistically significant relationship between gravimetric error and final volume. In order to manage this measure of control, the only requirements are to have a calibrated or verified scale, and staff trained in weighing. The margins of error in gravimetric control are clearly collected in the Spanish Consensus for Preparation of Parenteral Nutrition¹.

In those cases where PN is not administered immediately after preparation, and for home patients, the storage stage will acquire high importance. In the traceability process, the adequate temperature for storage and transportation must be controlled, and the chamber or fridge parameter should be recorded and documented. It is adequate to determine the place and manner allowed for storing these products^29,30.

In the administration process, the management of the infusion pump stage has been differentiated, because this should ensure an accurate and regular infusion rate during the programmed period. These pumps should meet a series of characteristics; and in home processes, patients and caregivers must be trained to use them and to interpret their warnings³¹. It is obvious that the measures of control should be established upon these two parameters (rate of infusion and time), and verification will be conducted on them.

Regarding the infusion pump, another CCP that must be controlled and should be included in vigilance would be the existence and integrity of a filter, to reduce air embolism and any potential sepsis³².

Of course, the administration itself of PN should be recorded, either by healthcare staff in the hospital process, or by management of the patient or caregiver in the home (community) process.

No specific stage has been determined for the microbiological control of the PN, because, as stated in the Spanish Consensus for Preparation of Parenteral Nutrition¹, this would not be feasible from a logistical and economic point of view. However, this does not mean that no measures should be established to allow to evaluate the process in order to detect deficiencies and apply corrective measures to improve it.

The American Society for Parenteral and Enteral Nutrition (ASPEN) considers that PN should be integrated within a standard system, in order to improve patient safety and clinical relevance, to maximize resource efficiency, and to minimize the incidents during the process²⁹.

We should mention that having a software application for the management of the traceability of the whole PN Process would facilitate to a high extent the follow-up of traceability management, and, particularly, having a historic record of all registries which would allow to evaluate the overall system at any time.

The future mHealth applications for care practice regarding clinical nutrition will be remote and assisted technologies for certain parameters and signs, looking for patient monitoring and, occasionally, patient self-control³³. The use of the QR codes (Quick Response code) offers the possibility of developing simple, cheap and functional systems based on optical recognition of low-cost stickers linked to physical objects. These are systems that, using the interaction with Web platforms, allow to provide advanced services, which are already currently widely used in many daily life settings. This system, based on the automatic recognition of messages embedded in these diagrams with devices of low software capacity, makes them ideal for their integration in the daily life of any type of users. Unfortunately, this potential has not been fully utilised yet in the area of nutrition sciences³⁴.

It is convenient to point out that in order to achieve the efficient operation of a management system, it is essential to create a setting in which all persons are completely involved³⁵. In this sense, Miana Mena and cols.¹⁴ concluded that the basic cornerstones for the implementation of a management system are the commitment of all members and the direction of this task, which should be integrated within the culture of the organization, and accepted as an activity in their daily work³⁶. New ideas will come out of their involvement and experience, which will help to improve the process.

One important limitation at the time of establishing a hazard analysis system is not having support plans adequately implemented (pre-requirements), targeted to controlling overall dangers. The minimal plans to be implemented are: a plan for water quality control, a plan for cleaning and disinfection, a training plan, a plan for preventive maintenance, a plan for plague control and vigilance system, a plan for waste control and, of course, the traceability plan which is essential in order to be adequately aware of all Process stages.

Based on the above, the conclusion could be that PN must be integrated within a standardized management system, with the aim to improve patient safety and clinical relevance, to maximize the efficiency of resources, and to minimize the incidents during the process. With the system suggested, an overall system could be implemented, with stages fully defined, that would allow their control and verification.

It would be desirable to have a software application that facilitated follow-up of the traceability management and, most of all, to have a historic record of all registries (stages) which would allow to evaluate the system at any time.

 

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Correspondence:
Correo electrónico: jsanz@umh.es
(Javier Sanz-Valero).

Recibido: el 27 de julio de 2015;
Aceptado: el 24 de agosto de 2015.