HFMEA Analysis of Chemotherapy in Pediatric Oncology Department

INTRODUCTION

Health care is often not as harmless as it has to be. A considerable body of evidence connects preventable medical errors as a chief cause of injury and mortality. These medical errors are the consequence of multiple inherent errors in the healthcare delivery system. For example, shortage of readily available dispensers for hand hygiene or sinks for hand washing near patient rooms may cause insufficient hand hygiene of the doctors and hospital staff. In addition, medication-associated errors are also one of the most common varieties of error, affecting the large numbers of people and accounting for a substantial raise in health care costs (Johnson, Jeffrey and Bootman, 1995). Similarly, paediatric oncology departments are known for their greater rate of medication errors. The medication errors in oncology are mainly related to chemotherapy and these may occur in any type of cancer treatment programs, with resultant severe effects like drug toxicity or bad influence on disease control. Drug administration is basically a multiprofessional course. The low therapeutic index and high toxicity of chemotherapy medicines make such errors a considerable issue, leading to unnecessary patient morbidity and expenditure (Dhamija, Kapoor and Juneja, 2014). Gandhi et al (2005) noted a 3% medication errors rate in a paediatric department where chemotherapy was infused. On the other hand, it was found that 60% of those blunders had the probability for unfavourable drug events. Good thing was that majority of these errors were stopped from being happening before they affected the patient. A study by Walsh et al (2009) also reported medication related error of about 18.8% in the paediatric oncology. Medication ordering was the most frequent types of errors noted in this study. Likewise, Taylor, Winter, Geyer and Hawkins (2006) demonstrated an error rate of 9.9% in chemotherapy medication administered orally in children with acute lymphoblastic leukaemia. Understanding and restraining chemotherapy errors are very important. In order to check and analysis such errors in health care, a number of methods have been implemented. Healthcare Failure Mode and Effects Analysis (HFMEA) is one of those methods. It is basically a qualitative methodology for identifying and amending such hidden system errors in the health care setting ahead of time such errors may lead to unpleasant outcomes.

The purpose of this study is to assess the safety of chemotherapy administration in cancer patients as well as to analyze potential failure modes in the pediatric oncology ward of a national medical center. It also aims to decrease the likelihood of failure in the administration process, chemotherapy order, and chemotherapy-associated prescribing errors cut off by clinical pharmacists before reaching the patient. HFMEA makes it easy to carry out the recognition of actions intended at decreasing medication errors in a healthcare setting, since the functioning of a number of these have already led to a lessening in errors in the prescription process of drugs, substantiation and dispensing.

METHODOLOGY

 Setting

A retrospectively review of records were carried out from visits to two paediatric oncology departments in the (city, country) for medication related errors by means of Healthcare Failure Mode and Effects Analysis (HFMEA). A multidisciplinary team conducted this review and this team comprised of paediatric oncologists, nurses, patient’s parents, pharmacists and a medical informatics. They mainly assembled to check and evaluate chemotherapy order, monitoring process and administration in all settings i.e. outpatient and inpatient in the paediatric patients. The HFMEA team was led by the head of paediatric oncology department. The team was also included of two nurses’ expert in providing paramedical task during chemotherapy.

The team recognized a variety of ways in which each constituent of the process may fall short. Failure modes were described, and values were assigned for each failure mode, to two attributes of each failure mode: probability and severity. A probability index explains the probability of incidence of the failure mode and can take one of the four values: value = 1(remote) specifies that it is dubious to happen in the next five years; value = 2 (rare) shows it is likely to happen in the next five years; value = 3 (sporadic) designates a likelihood of incidence of once or twice a year and final value of 4 (frequent) shows that it is probable to happen instantly or at a number of times a year (DeRosier, Stalhandske, Bagian, et al., 2002). On the other hand, severity index was given four values. The index value basically defines the failure outcomes. The values assigned include: score = 1(negligible) signifies no harm to the patient, call for high level of care or stay length; score = 2 (moderate) signifies extended period of stay or high level of care for patients; score = 3 (major) demonstrates permanent diminishing of function of the body for a single patient or extended period of stay or a need for high degree of care for 3 or more than 3 patients; and score = 4 (disastrous) shows permanent loss of function or motility for any patient (DeRosier, Stalhandske, Bagian, et al., 2002).

The particular topic of the HFMEA was decided by conversations with the paediatric oncology Department and hospital management group. The administrative group of the hospital then officially commissioned the HFMEA to be executed. A flow diagram of the practice was developed and possible failure modes were recognized and accessed via a hazard scoring matrix.  For each failure mode a hazard score was calculated by multiplying the probability and severity indices producing values varying between one as a smallest value and sixteen as a highest hazard score (DeRosier, Stalhandske, Bagian, et al., 2002). Finally by the help of the decision tree the failure mode requiring further actions were determined. A decision tree was used based on a hazard score equal or above 8. Corrective interventions for failure modes with the maximum hazard scores were made and prioritized. Ethical consideration was not done here because the study mainly involved identification and detection of ongoing safety program without including patients in the study.

Procedure

During the process of the HFMEA, necessary information was gathered by the team from records, meetings, and interviews. The interviews were mainly conducted from doctors responsible for infusion of chemotherapy in the children suffering from cancers to shed light on areas of vagueness in interpreting the important chemotherapy associated guidelines. Members of the paediatric oncology department also attended a meeting for additional conversations with the HFMEA team. The record material mainly comprises the tools for chemotherapy monitoring, administration

RESULTS

HFMEA analysis and flow Process

An overview of the order of chemotherapy and administration process is shown in Fig.1.  The whole process was grouped into seven main steps and these were prescription, confirmation, entry of order, review of order, transmission, administration of drugs and monitoring.

Order received and entered into pharmacy system. Nurses were asked to administered the medication

Yes

Oncologist contacted for revision or justification

No

                                                   

						No
											Pharmacist contacted for revision or elucidation.
		Nurses review the order: Is this fine?
	Patient monitored.

 

               Fig. 1: Flow diagram of chemotherapy process

Hazard Analysis and Failure Modes

The hazard analysis found 15 potential failure modes with altering degree of rate of incidences and intensity of outcomes. A sum of three failure modes had the maximum likely hazard score of 11, demonstrating the collective possibility for recurrent occurrences i.e. expected to take place instantly and temporary and a disastrous result (demise or permanent function loss). Table 1 exhibits the failure modes with the maximum hazard scores and subsequent recommendations by the HFMEA team. A number of steps e.g. order review, prescription of chemotherapy drugs, steps of monitoring and administration were linked to the failure modes of the greatest mutual likelihood and severity.

Handwritten prescriptions and signed by unofficial prescribers, chemo administered and reassessed by un-authorized nurses were linked to the possibility of producing adverse outcomes. Therefore, team suggested implementing a number of guidelines and recommendation for chemotherapy infusion in paediatric oncology with necessary protections, as given below in table 1. These include review of a process of prescription order by authorized nursing staff, tutoring nurses and oncologists regarding the significance of improving safety of chemotherapy and enlightening patients about unfavourable effects of chemotherapy medicines.

Procedure	Failure modes with hazard score = 11	Recommendations by team
chemotherapy prescribed	handwritten prescriptions orders	Practise computerized prescriber for chemotherapy orders entry with proper safeguards
	Prescriptions reassessed by un-authorized nurses
Chemotherapy drugs administered and noted	Barcode detection is avoided	Instruct nurses regarding the significance of barcode recognition to chemotherapy safety
Oral chemotherapy order reviewed by nurse	Prescription written by unofficial prescriber	Implement a procedure to give review to the prescription by a chemotherapy-certified oncologists or nurses
	Mistakes in frequency or dosing not noticed	Guidelines for chemotherapy medication is needed to be developed, comprising of information for dosing, modifications, safety measures and contraindications
Patient monitored for unfavourable outcomes	Patient is not aware of or remember instructions	Make pamphlets containing information for patients

Table 1: HFMEA identified Failure modes linked to the maximum hazard scores and subsequent recommendations by team.

Discussion

The HFMEA methodology was used to address problems not amenable to quantitative methods: the assessment of medication and system errors in the process of administration of chemotherapy in paediatric population. Chemotherapy drug safety practices and understanding is still suboptimal. While a number of guidelines have deal with these issue and ensured safe administration and handling of anticancerous agents (Jacobson, Polovich, McNiff, et al., 2009; Griffin, 2003). Hardly any have recommend standards to decrease chemotherapy prescribing mistakes. This can be explained by the fact that a great number of hospitals did not have particular obligations for prescriptions of chemotherapy (Weingart, Flug, Brouillard, et al., 2007).Quality-enhancement programs are planned to accomplish the axiom ‘above all-do no harm’ (Smith, 2005). In this particular study and hospitals assessed, and in response to better knowledge regarding the safety risks linked to chemotherapy, the chemotherapy process was proactively evaluated with a particular attention on prescribing, ordering and administration by means of HFMEA. HFMEA is a mean that attempts to methodically evaluate. This evaluation may either be retrospectively or prospectively and is a multifaceted process. It distinguishes those factors which have the risk of causing damage and prioritizing corrective interventions. The HFMEA is recommended to be used as a proactive risk evaluation tool. Several studies have reported it successful utilisation of HFMEA in medicine as well in enhancing chemotherapy safety (Bonnabry, Cingria, Ackermann, et al., 2006; Van Tilburg, Leistikow, Rademaker, et al.  2006; Bonfant, Belfanti, Paternoster, et al., 2010). However, it is important to note that HFMEA must not be considered as the mere mean for quality enhancement by healthcare institutions, because the knack to recognize and assess failure modes in any practice considerably relies on the team evaluating the practice (Shebl, Franklin and Barber, 2009).

Conclusion

HFMEA offered valuable analysis of the chemotherapy practice in the paediatric oncology in three hospitals. And thus, interventions were put into practice to lessen risk and enhance patient safety. The recommendations and implementation from this HFMEA analysis are believed to offer an encouraging outcome on a big number of other processes of medication. The findings of this study are in accord with different other published HFMEA analysis taken place in a paediatric oncology department where chemotherapy prescription and administration were found to have greatest hazard scores (Robinson, Heigham, and Clark, 2006).

HFMEA is now actively carried out in numerous healthcare processes and in oncology it serves a great role since chemotherapy is considered to be a high-risk course. Using HFMEA potential risk can easily be identified and corrective measures can be taken to curtail those risk.  In addition, computerized physician order entry (CPOE) is successful in decreasing prescribing errors of antineoplastic agents and should be regarded as a component of a fail-safe practice to enhance safety.

There are some limitations in this study, including the failure to carry out repeat HFMEA analysis.  Furthermore, there is a need for more detailed and thorough research on the effectiveness of HFMEA analysis in the healthcare processes in general and in paediatric oncology department in particular.

References

Bonfant G, Belfanti P, Paternoster G, et al. (2010). Clinical risk analysis with failure mode and effect analysis (FMEA) model in a dialysis unit. J Nephrol 23,111-8.

Bonnabry P, Cingria L, Ackermann M, et al. (2006). Use of a prospective risk analysis method to improve the safety of the cancer chemotherapy process. Int J Qual Health Care 18, 9-16

Dhamija M¹, Kapoor G, Juneja A. (2014). Infusional chemotherapy and medication errors in a tertiary care pediatric cancer unit in a resource-limited setting. J Pediatr Hematol Oncol. 36(7), 412-5.

Gandhi TK, Bartel SB, Shulman LN, et al. (2005). Medication safety in the ambulatory chemotherapy setting. Cancer.  104, 2477–2483.

Griffin E. (2003). Safety considerations and safe handling of oral chemotherapy agents. Clin J Oncol Nurs 7(6 Suppl.), 25-9.

Jacobson JO, Polovich M, McNiff KK, et al. (2009). American society of clinical oncology/oncology nursing society chemotherapy administration safety standards. J Clin Oncol 27, 5469-75.

Johnson, Jeffrey A and Bootman, J. L. (1995). Drug-Related Morbidity and Mortality: A Cost-of-Illness Model. Arch Intern Med. 155(18), 1949–1956. DeRosier J, Stalhandske E, Bagian JP, et al. (2002).Using health care failure mode and effect analysis: the VA national center for patient safety's prospective risk analysis system. Jt Comm J Qual Improv 28, 248-67.

Robinson DL, Heigham M, Clark J. (2006). Using failure mode and effects analysis for safe administration of chemotherapy to hospitalized children with cancer. Jt Comm J Qual Patient Saf.  32,161-6.

Shebl NA, Franklin BD, Barber N. (2009). Is failure mode and effects analysis reliable? J Patient Saf, 5, 86-94.

Smith CM. (2005). Origin and uses of primum non nocere-above all, do no harm. J Clin Pharmacology 45, 371-7

Taylor JA, Winter L, Geyer LJ, et al. (2006).Oral outpatient chemotherapy medication errors in children with acute lymphoblastic leukemia. Cancer.  107, 1400–1406.

Van Tilburg CM, Leistikow IP, Rademaker CMA, et al. (2006). Health care failure mode and effect analysis: useful proactive risk analysis in a pediatric oncology ward. Qual Saf Health Care 15, 58-63.

Walsh KE, Dodd KS, Seetharaman K, et al. (2009). Medication errors among adults and children with cancer in the outpatient setting. J Clin Oncol. 27, 891–896.

Weingart SN, Flug J, Brouillard D, et al. (2007). Oral chemotherapy safety practices at US cancer centers: questionnaire survey. BMJ 334, 407-9.

HFMEA Analysis of Chemotherapy in Pediatric Oncology Department 2

Introduction

Medical errors have been defined as adverse events that can impact the health and well-being of patients in the healthcare environment. The causes of medical errors can be multiple including equipment failures, poor staff training, poor communication processes, flawed healthcare structural processes, and others (Wachter, 2012). Medication errors are found to be prevalent in the pediatric inpatient setting. The potential for medication related patient injury is high in pediatric patients because they are unable to communicate regarding the side effects of improper medication administered. Pediatric patients need to be given dosage based on their weights which is an extensive process that involves calculations (Shekelle et al, 2013). In addition, the stock solutions have to be diluted in order to achieve success. A small dosage error for adult patients can have adverse impact in small children. Specifically, care must be undertaken for children that are undergoing chemotherapy for cancer treatment.  The Health Care Failure Mode and Effect Analysis (HFMEA) tool uses five steps in order to analyze the healthcare process. The use of hazard scoring matrix and flow diagrams helps to achieve the critical objectives. Additionally, the hazards can be identified based on their severity by the tool. The recommend modes of action can be identified through the use of this tool. The aim of this paper is to analyze the prescription process for chemotherapy patients in the pediatric oncology ward of a national medical center.

Setting

The research has been conducted at a medical center that comprises of a university hospital, children’s hospital, and medical facility. The medical center has approximately 9,000 employees with the children’s hospital located in a separate structure. The children’s hospital has a total of 143 beds with the oncology ward having 300 admissions in the year 2014. The age of children admitted was between 0-19 years. There is a separate pharmacy for the children’s hospital that evaluates the ordered medications. This is done in order to identify the interactions and body surface area as well as the uniformity with the chemotherapy schedule for each patient. The practitioners that use the system are provided complete information regarding the medication. The registered pediatric oncologist uses a separate system to approve the chemotherapy medications. After the approval process, the pharmacy department will send the medication for the specific patient.

Composition of HFMEA team

A number of practitioners belonging to multiple disciplines were selected on the basis of HFMEA guidelines. There were nine members while two advisors were included in the multidisciplinary team. Additionally, a parent was involved because her child has been receiving chemotherapy treatment for the past one year. The team was led by the hospital’s patient safety coordinator. The other members were from the pharmacy, pediatric oncology department, nursing department, and medical department.

Process Description

Prescription

This process involves the prescription of medications for the child patient that is admitted in the hospital. The treatment schedule in the chart is selected with proper dose calculation and prescription entry into the system by the resident in the pediatric oncology department. The prescription is printed out with the supportive care orders documented by the resident. The prescription print out is sent to the nursing department. An oncologist must authorize the prescription. After that, the prescription print out is processed and checked by the nurses. 

Processing Pharmacy

The prescription is matched with the treatment schedule for the patient. The preparation protocol mode is initiated which is evaluated by the pharmacist. The authorization from the oncologist is processed while the department strives to ensure that the medication is prepared. The medication is properly labeled and presented in a tube so that it can be checked by the pharmacist before being finally handed over to the nursing department.

Administration

The administration department collects the medication from the pharmacy department and stores it in the refrigerator. The prescription is checked with the print out and handed over to the nurses. The nurses connect the medication tube to the patient while striving to adjust the medication pump in the patient. The pump is started so that the medication can be administered to the patient. When this process is finished than the pump is flushed out while the nurses mark that the medication has been administered to the patient.

Failure Modes

One of the primary hazards that have been identified is related to the chemotherapy treatment schedule that is depicted through charts. This occurs because of the fact that pediatric oncologist did not provide timely updates on the chart.  Another hazard is related to improper dosage by the resident in the pediatric oncology department. The possible causes for this hazard are the increased number of hours for residents. Alternatively, the use of pagers in the department can also distract the resident when they are preparing the dosage for chemotherapy. Other hazards identified in the analysis have been the failure of the nursing staff and pharmacy department to check the changes in prescription of medication that is used for chemotherapy for young patients. The causes can be failure of the department to check out the prescription as well as the resident failing to inform the nurses. Another hazard identified has been old dose delivered by the pharmacy once authorized medication has been changed for the patients. Finally, another hazard that was identified was extravasation of peripheral venous access which is a rare process. This means that residents or nurses are unaware of the risks of peripheral venous access.

Recommended Actions

A standardized chemotherapy chart scheduled has been recommended because the standard procedure for changes can help to implement high levels of uniformity and consistency with respect to provision of care to the oncology patients (Keers et al, 2013). Moreover, standardized processes help to ensure that practitioners can work in an integrated manner in order to respond to problems. The information can be accessed which helps to achieve efficiency and effectiveness. Another important recommendation is to reduce the work hours that can play an instrumental role in mitigating medical errors. New doctors that join a team are at higher risks of making prescription errors.

The recommendation is therefore to place minimum number of residents in the pediatric oncology ward. The use of pagers was prohibited because it can cause distraction in the ward. Additionally, the residents are provided with maximum concentration for prescribing chemotherapy in a separate room in order to reduce the chances of errors.  Another recommendation is to implement an electronically controlled administration system that would help to provide sound information to the healthcare workforce. This is because the changes in prescriptions that have been authorized go disregarded by the nursing staff (Keers et al, 2013).

 The pharmacy department would be notified by telephone about changes in medications. This is because the pharmacy department might deliver the incorrect chemotherapy once change has been implemented in an authorized order. This is done in order to prevent medication errors so that patient safety can be promoted in an efficient and effective manner. Vincristine should be a administered by a peripheral intravenous access by a trained pediatric oncologist in order to ensure efficiency. Nurses and residents do not have knowledge about the risk of extravasation of the heart when peripheral intravenous access is used for the purposes of treating the patients.

Discussion

Prescription errors are a critical issue in the healthcare environment as they can prolong the hospitalization stays for patients. In other cases, prescription errors might be fatal for the patient. Specifically, the prescription errors can increase costs for the patient as well as the hospital. HFMEA is an appropriate tool for diagnosing problems and hazards that are encountered in the healthcare environment (Ghaferi & Dimick, 2015).

In addition, it can be used for analyzing the prescription process in a pediatric oncology ward. The case discusses the administration of chemotherapy which is vincristine. The analysis suggests that there are multiple hazards that can cause medication errors and jeopardize patient safety. Prescription errors can be multifaceted in nature because of the analysis that has been undertaken in this paper. The analysis using the HFMEA tool is important since it helps to identify the multiple hazards and the possible solutions to resolve them. It provides accurate and reliable information to the management so that they can make critical decisions that can lead to high levels of efficiency and effectiveness. The recommendations target the specific failure modes by using proactive and dynamic strategies in order mitigate the chances of errors related to prescription in the oncology ward (Duwe et al, 2005). The HFMEA was conducted through a multidisciplinary team which helps to achieve the critical objectives of analyzing hazards in the healthcare environment. In addition, a parent was part of the team because they can provide valuable feedback about the entire process. Specifically, the success of HFMEA occurs when the hospital management is involved in the entire process. The analysis suggests that administrative and technological processes need to be implemented in order to reduce prescription errors. Moreover, the staff must be appropriately trained so that they can work in providing continuity of care for the patients. The staff must be aware about the implications of prescription errors. Communication processes need to be strengthened so that prescription errors can be mitigated. The flow and exchange of information should be done in a consistent manner in order to reduce the chances of errors. Technology can be used to create quality and efficient healthcare services in the oncology department. It can be used for storing patient information and medication information which is vital for the success of the medical center (Shebl et al, 2012).

Conclusion

HFMEA is an appropriate tool that has been used to study the medication errors that can occur in the pediatric oncology ward of a national medical center. Medication errors need to be combated through the presence of a patient safety culture. The staff must work in a coordinated manner with each other so that they are able to successfully develop proactive and dynamic strategies in responding to problems occurring in the environment. Proper research and analysis is important for the healthcare team so that they can identify the source of medication errors. The HFMEA tool used for the oncology department found that there are several sources of medication errors in the hospital environment. A proactive and integrated strategy is needed in order to combat the problem. This can be done through the use of clear and precise goals. Another recommendation is to implement an electronically controlled administration system that would help to provide sound information to the healthcare workforce. This is because the changes in prescriptions that have been authorized go disregarded by the nursing staff.  The pharmacy department would be notified by telephone about changes in medications. This is because the pharmacy department might deliver the incorrect chemotherapy once change has been implemented in an authorized order. This is done in order to prevent medication errors so that patient safety can be promoted in an efficient and effective manner.

References

Duwe B, Fuchs B D, Hansen‐Flaschen J. (2005). Failure mode and effects analysis application to critical care medicine. Crit Care Clin 2121–30, vii.3

Ghaferi, A. A., & Dimick, J. B. (2015). Understanding Failure to Rescue and Improving Safety Culture. Annals of surgery, 261(5), 839-840.

Keers, R. N., Williams, S. D., Cooke, J., & Ashcroft, D. M. (2013). Prevalence and nature of medication administration errors in health care settings: a systematic review of direct observational evidence. Annals of Pharmacotherapy, 47(2), 237-256.

Keers, R. N., Williams, S. D., Cooke, J., & Ashcroft, D. M. (2013). Causes of medication administration errors in hospitals: a systematic review of quantitative and qualitative evidence. Drug safety, 36(11), 1045-1067.

Shebl, N. A., Franklin, B. D., & Barber, N. (2012). Failure mode and effects analysis outputs: are they valid?. BMC health services research, 12(1), 150.

Shekelle, P. G., Pronovost, P. J., Wachter, R. M., McDonald, K. M., Schoelles, K., Dy, S. M., ... & Bates, D. W. (2013). The top patient safety strategies that can be encouraged for adoption now. Annals of Internal Medicine, 158(5_Part_2), 365-368.

Wachter, R. M. (2012). Understanding patient safety. McGraw Hill Medical.

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