JACIE and Quality Management in HSCT: Implications for Nursing

Laboratory medicine, along with the airline industry, has a long history of utilising quality management systems. It took until 1999 for The Joint Accreditation Committee of the International Society for Cellular Therapy (ISCT) and the European Group for Blood and Marrow Transplantation (EBMT), known as JACIE, to be established as an accreditation system in the field of haematopoietic stem cell transplantation (HSCT). The aim was to create a standardised system of accreditation to be officially recognised across Europe and was based on the accreditation standards established by the US-based Foundation for the Accreditation of Cellular Therapy (FACT).

Peripheral Stem Cell/Bone Marrow/Cord Blood Bone Marrow Res. (2012):Article ID 834040 (online)). However, there is a lack of published evidence demonstrating that this improvement directly results from better nursing care. Therefore, the authors conducted a survey of nursing members of the European Blood and Marrow Transplantation Nurses Group (EBMT (NG)) to identify how nurses working in the area of HSCT felt that JACIE impacted in the care they delivered and the general implications of JACIE for nurses.

Background to JACIE
The 1990s saw an increase in the number of transplant teams performing haematopoietic stem cell transplantation (HSCT) (Passweg et al. 2012). The procedure that was initially considered experimental during the 1960s/1970s was becoming an established treatment for many blood cancers, solid tumours and acquired or congenital disorders of the haematopoietic system within adult and paediatric populations. Towards the end of the 1990s, the source of haematopoietic stem cells was collectable from the marrow, peripheral blood and cord blood and from autologous, sibling and unrelated donations (Demiriz et al. 2012).
In 1998 two leading European scientific organisations, The International Society for Cellular Therapy (ISCT) Europe and the European Group for Blood and Marrow Transplantation (EBMT), formed a joint committee to be known as the Joint Accreditation Committee for ISCT and EBMT (JACIE) (JACIE n.d.;Cornish 2008). The purpose of this new committee was to establish a system to allow transplant teams to self-assess against a group of standards (Cornish 2008), provide an inspection process and recognise compliance with the standards by awarding accreditation to those teams who worked within the field of HSCT. A pilot study of the JACIE inspection and accreditation process was carried out in Spain 2000Spain -2002 This enabled JACIE to assess sections of the stan-dards that gave rise to common difficulty experienced by the transplant teams and to assess what assistance, if any, would be required by the centres for them to obtain accreditation. The results of this pilot study underlined the need to implement national and international regulations (Pamphilon et al. 2008) within each European country. In January 2004, with the support from the European Union under the Public Health Programme (2003)(2004)(2005)(2006)(2007)(2008), the JACIE accreditation process was launched (Pamphilon et al. 2008).
To enable a set of international standards for the provision of quality medical, nursing and laboratory practice in HSCT transplantation to be developed and recognised, JACIE collaborated with their American counterparts, the Foundation for the Accreditation of Cellular Therapy (FACT) (JACIE). The "FACT-JACIE International Standards for Hematopoietic Cellular Therapy Product Collection, Processing, and Administration" are revised on a regular basis.
JACIE remains a non-profit organisation with all members being an expert within their specialty: clinical, collection or processing procedures of HSCT. Clinicians, nurses and quality managers who are experts in their field can volunteer to become JACIE inspectors, if they meet the criteria set. Potential inspectors must attend a training programme, pass the inspector's exam and act as an observer within the inspection team as a trainee before their first official JACIE inspection. As the JACIE accreditation process has evolved, the inspection team membership has extended to include apheresis nurses and more recently experienced quality managers recognising the multi-professional components of our HSCT programmes. The accreditation process is continuous reflecting an established quality management system (QMS); therefore accredited centres are required to apply for reaccreditation every 4 years. In 2016, many transplant teams were achieving reaccreditation for the 2nd or 3rd time, whilst other centres are applying for their initial application. At the beginning of December 2016, the JACIE website (www.jacie.org) (2016) cited 334 successful initial accreditations; 197 successful reaccreditations from 26 countries had been granted since 2000. Although the initial aim of the accreditation scheme was a voluntary process, in many countries, health-care systems/ commissioners or health insurance providers and tissue banking authorities increasingly view JACIE accreditation as important and demand accreditation to allow the procedure of HSCT to be performed.
Accreditation is the means by which a centre can demonstrate that it is performing to a required level of practice in accordance with agreed standards of excellence. Essentially it allows a centre to certify that it operates an effective QMS. Furthermore, due to the increased use of unrelated donors from different countries, interaction and collaboration between units are key elements for the success of stem cell transplantation. JACIE accreditation is a guarantee that the donor and the cellular product have been handled according to specific safety criteria.
A QMS is a mechanism to: • Ensure that procedures are being performed in line with agreed standards, with full participation by all staff members. In a HSCT programme, this ensures that the clinical, collection and laboratory facilities are all working together to achieve excellent communication, effective common work practices, shared policies where appropriate and increases guarantees for improved patient outcomes and the use of international donor criteria for related donors (Gratwohl et al. 2014;Anthias et al. 2015Anthias et al. , 2016. Nurses have successfully taking on the role of improving communications for donor mobilisation, collections and liaising with the staff of the processing facility. • Track and monitor collected cell products for safety and viability from the time of donation to the administration procedure. Patients' medical records must include not only the information of date and time of the collection but should include volume of collected product, type and volume of citrate and the product identification. A transport log will be required to ensure traceability of all products from collection to processing and then to clinical for administration. • Identify errors and incidents that can be reviewed and corrective actions be implemented and allow a plan of action to be put into place to minimise the error reoccurring. • Formalise training and competencies. • Clearly identify the roles and responsibilities of all staff working within the transplant team or with outside agencies (clinical, collection, processing and support services; intensive care, radiotherapy, cleaning and transport services, laboratories and donor panels). • Review documentation for evidence that standards have achieved compliance on a regular basis.

Considerations
In the early stages of preparing for accreditation, extra resources may be required: a dedicated quality manager, data collection manager and support staff (pharmacist, dietician, social worker) to fulfil the standards and prepare for the inspection. Formalisation of the QMS and accreditation will depend on structures already in place.
There will be many processing facilities that are independent from the clinical transplant teams and may also be responsible for collections of apheresis products. In this situation, the processing facility and clinical facility have a choice of accreditation. They may decide to apply for separate or combined accreditation. However, in order to obtain JACIE accreditation, it is important that the QMS describes the communication processes between all facilities involved and provides the evidence that communications exist, e.g. minutes of weekly, monthly and annual meetings must include the names of the attendees, sharing evidence of engraftment and adverse events. It is important to remember a clinical facility must use an apheresis and processing facility that are JACIE accredited. Similarly, an apheresis facility must use a processing facility that is accredited before clinical and apheresis facilities can be awarded JACIE accreditation.

Implementing a Quality Management System
HSCT is a procedure with a high technological content, which requires extensive attention towards patients/donors who might introduce important problematic clinical factors and also towards sophisticated laboratory procedures related to the collection, manipulation, cryopreservation and transplantation of haematopoietic stem cells (HSCs). The continuous improvement of stem cell technology requires that all procedures regarding HSCT be guaranteed through the definition of qualitative standards recognised by scientific associations and international organisations. For the collection, processing and transplantation of HSCs, there are standardised procedures, which require specific clinical, haematological and laboratory knowledge and strict quality controls concerning all processes from cellular collection and manipulation to the administration of the collected product. Stem cell collection, processing, storage and transplantation must be carried out in a highly regulated manner to guarantee both safety and clinical efficacy. Therefore, quality assurance is a very important topic at all levels of HSCT, including robust nursing procedures, e.g. chemotherapy administration, use of stem cell mobilisation agents and collection of cellular material. The implementation of a QMS arises from the need to develop an appropriate system to optimise the quality of the service offered by a stem cell transplantation unit, in a general context of health-care quality improvement. A QMS is a tool that can be used to rapidly identify errors or accidents and resolve them to minimise the risk of repetition. A QMS assists in training and clearly identifies the roles and responsibilities of all staff (Cornish 2008;Caunday et al. 2009).
In 1966, Avedis Donabedian wrote a paper entitled "Evaluating the Quality of Medical Care", where the concepts of structure, process and outcome in health care were introduced. The structure includes not only the physical aspects in which care is given but also the resources and tools available to the health-care team, the leadership and the staff. The process is how the health-care system and the patient interact. The outcome includes the effect of care on diseases and their prevention, such as the mortality rate, the error rate and the quality of life (Samson et al. 2007).
During the 1950s, Edwards Deming introduced the plan-do-check-act (PDCA) cycle, an iterative four-step management method used for the implementation and improvements of processes and products, also known as plan-dostudy-act (PDSA). He also stressed the importance of viewing problems in the context of a system and that most mistakes were not the fault of the worker (Samson et al. 2007).
The major objective of the JACIE Standards is to promote quality medical and laboratory practice in HSCT and other therapies using cellular products; therefore dedicated quality management standards are found within the FACT-JACIE manual (clinical facility B04, marrow collection facility CM04, apheresis collection facility C04, processing facility D04).
Quality management is the management of activities involved in quality assessment, assurance and control that try to improve the quality of patient care, products and services in cellular therapy activities.
A QMS could be implemented applying the PDCA cycle for the management and continuous improvement of processes and products.
• PLAN means to establish the objectives and processes necessary to the centre. This means define the scope of the QMS and identify which processes within the scope are most important, those staff who are involved in the important processes and involve them in defining the targets to be used to measure the quality of the process. Ensure all staff knows how they can contribute to achieve the performance required.
One important aspect to consider when implementing a QMS is the organisation and interaction between the different facilities (clinical, collection and processing). The plan shall include an organisational chart of functions, considering clinical, collection and processing staff, in particular for those tasks that are critical to assuring product or service quality. Training plans should be defined and put in place. Documentation may be displayed in a variety of formats (job descriptions, training records, qualifications certificates, retraining).
A document system should be implemented serving multiple purposes for the QM programme. They provide instructions on: • Activities, policies and processes controlling various steps within the activities • Quality control and traceability of products, donor and patients The Quality Management Plan (QMP) (or Quality Management Manual) should be one of the first documents developed when preparing for JACIE accreditation. The centre must have a standard operating procedure (SOP) outlining the method by which to create, approve, implement and update SOPs (known as the "SOP for SOPs"). Clinical and collection protocols or laboratory methods must be translated into written procedures, in paper form or an electronic version, and readily available to staff. The purpose of document control is to ensure the correct approved documents are in use.
In the 6th edition of the FACT-JACIE Standards, more specific requirements for validation and qualification studies have been delineated, and the concept of risk assessment has been implemented.
• Validation is documented evidence that the performance of a specific process meets the requirements for the intended application. For example, the procedure for thawing frozen cells should be evaluated, as there is a risk of contamination and loss of cells during the thawing process. A thawing control, on three procedures, could be performed to assess these criteria would validate the process. • Qualification is documented evidence that the equipment/facility/utility is meeting the user requirement specification, working correctly and leading to the expected results. For example, "the dry shipper used for the transportation of frozen haematopoietic stem cells should be validated for temperature control".
During the implementation phase, risk management should be an ongoing part of the quality management process, to minimise hazards for processes, patients and staff. There are several methods for the assessment of the risk, such as Failure Mode and Effects Analysis (FMEA) or Failure Modes, Effects and Criticality Analysis (FMECA), methods of assessing potential failure mechanisms and their impact on system, identifying single failure points.
• DO means to implement the plan, execute the process and carry on the activities. Once the programme has been established and staff trained, the activities and the quality plan should be maintained, through the document system and the available resources. Policies and procedures could be revised, training programmes implemented and the outcome analysis of cellular therapy product efficacy reviewed to verify that the processes in use provide a safe and effective product. • CHECK is to measure the results and compare them against the expected results or goals defined by the plan. Audits represent one of the principal activities in this step and should be documented, independent inspection and retrospective review of activities to determine if they are performed according to written procedure and specified endpoints. They should be conducted to ensure that the QMS is operating effectively and to identify trends and recurring problems in all aspects of the programme. Moreover, the transplant programme should manage errors, accidents, deviations, adverse reactions and complaints and monitor activities, processes and products using measurable indicators (Harolds 2015). • Finally, ACT is to improve the QMS based on the results of the previous steps. Investigation of errors and indicators and the implementation of corrective or improvement strategies are undertaken and monitored with follow-up assessment to determine the effectiveness of the change.
Data shown by Gratwohl and colleagues (Gratwohl et al. 2014) demonstrates the use of a clinical quality management system is associated with improved survival of patients undergoing allogeneic HSCT.

1.3
The JACIE Accreditation Process

Start Working with the Standards
The JACIE accreditation process begins when the transplant centre, with the support of the hospital management team (a key element in order to assure the required resources to successfully implement the JACIE accreditation process), agrees to start working according to the JACIE Standards.
It is important to gather all the necessary information before commencing the JACIE accreditation pathway. First read the JACIE Standards, access the guides, manuals and supporting documentation from the JACIE website (www.jacie. org). Then utilise the JACIE Inspection Checklist as a self-evaluation tool. This document contains all the JACIE Standards and will help the centre establish their level of compliance against each standard and identify further work required to achieve accreditation. Furthermore, the checklist is the pivotal tool used continually throughout the JACIE accreditation process, until JACIE accreditation has been awarded.

Application for JACIE Accreditation
When the applicant has established a mature QMS, i.e. has been in place and operational for at least a year, a self-assessment of the standards has been performed and shows a high percentage of compliance the centre can formally apply for JACIE accreditation. The completed application form and inspection checklist should be submitted to the JACIE Office where the JACIE team will review and approve the application form, finalising this part of the process by signing the accreditation agreement with the centre. Within 30 days of the application being approved, the applicant will be required to provide the preaudit documentation to the JACIE Office. The JACIE team and the inspectors will determine that all required documentation has been correctly submitted. The documents can be provided in the language of the centre/applicant; however in some exceptional cases, a translation in English of some key documents can be requested. The preaudit documentation should be submitted using the predefined folder structure described on the JACIE website, which includes relevant documentation for all areas of the Stem Cell Transplant Programme such as personnel documentation, donor consent information, labels and summary of QMS activities (Quality Management Plan, audit report, policies).

Arranging the Inspection Date
The JACIE Office will begin the process to assign an inspection date and the inspection team. However, this part of the process can take approximately 6 months from the approval of the application. The inspection team will consist of one inspector per facility to be inspected. For example, if the applicant has applied for adult clinical and bone marrow, apheresis and processing accreditation, the inspection team will consist of the following: clinical, apheresis and a processing inspector (The clinical inspector will be responsible for clinical and marrow collection facilities). The inspectors are selected according to their area of expertise: clinical, apheresis and processing. For instance, a clinician will inspect the clinical facility. If a paediatric unit is part of the inspection, a paediatrician will be assigned. When there is more than one facility per area, for instance, two apheresis units, an extra collection inspector will be included in the inspection team.
The applicant will be invited to view the list of JACIE inspectors, found on the JACIE website, and inform the JACIE Office if there are any inspectors that they prefer not to participate in their inspection, due to conflict of interest. The inspection will be performed in the language of the centre unless there are no JACIE inspectors that speak the language of the applicant centre; in these cases, the inspection will be performed in English with language support.

The Inspection
The inspection will take place over a period of 1-2 days and is a thorough examination of all aspects of the programme. The inspector will use the inspection checklist previously completed by the applicant to evaluate the centre's compliance with the standards.
The inspection is usually divided in the following parts: • Introductory meeting by the programme director and the inspection team with all the programme personnel • MEDA/B data audit and review of documentation • Interviews with personnel • Closing meeting with programme director • Closing meeting summarising the inspection results with the transplant team

The Inspection Report
Following inspection, the inspectors submit their completed written report and inspection checklist to the JACIE Office. The inspection report is a fundamental part of the accreditation process. The report will be prepared and presented to the JACIE Accreditation Committee by the JACIE Report Assessors after their review and confirmation with the inspectors over any issues, if necessary. The Accreditation Committee is a group of experts from all areas of Stem Cell Transplantation (Clinical, Collection and Processing) that discusses each individual report and determines corrective actions the centre is required to implement in order to achieve the JACIE accreditation. Please bear in mind that although the inspectors identify areas of non-compliance, it is the JACIE Accreditation Committee who decide the corrective actions, not the inspectors.

Corrections and Accreditation Award
A high percentage of all inspections reveal deficiencies and the degree of deficiency identified will vary in seriousness. In most cases, evidence of corrections can be submitted electronically. However, if the deficiencies are considered a risk for patients, donors or personnel, a focussed reinspection will be required before JACIE accreditation can be finalised. Centres are allowed a period between 6 and 9 months to implement and submit the corrections to the JACIE Office. The same team of inspectors will review and assess the adequacy of the corrections provided by the centre. Once the inspectors are satisfied that all points have been resolved and with the approval of the JACIE Accreditation Committee, the applicant will be awarded the JACIE accreditation for a 4-year period, subject to an interim audit at the end of the second year.

Post JACIE Accreditation
The inspection is the most visible part of the JACIE accreditation process. The most challenging part, once the JACIE accreditation has been awarded, is maintaining accreditation. At the second year of accreditation, the interim audit will be due, and if the system has not been maintained, the hard work invested in achieving accreditation will become void and centres return to the beginning of the process when applying for reaccreditation.
The JACIE Committee warns against failing to uphold standards or maintain the QMS between inspections. Those centres that fail to maintain their QMS due to lack of commitment or allow their system to devolve may discover standards that were compliant at the initial inspection may become partially or noncompliant during the inspection required for reaccreditation. Inspectors will identify failures to review documentation, perform audits and maintain competencies due to the lack of available evidence during the accreditation cycle.

JACIE Standards that Affect Nursing: Clinical and Collection
The JACIE Standards are divided into sections: clinical and donor (B), collection of marrow (CM), apheresis products(C) and laboratory (D). Many of these standards are shared across each facility as appropriate ( There shall be a nurse/patient ratio satisfactory to manage the severity of the patients' clinical status.
Administration of cellular therapy products.
Care of immunocompromised patients.
There shall be written policies for all relevant nursing procedures, including, but not limited to: Palliative and end of life care.
Administration of blood products, growth factors, cellular therapy products, and other supportive therapies.
Training and competency shall include: Clinical Programs treating pediatric patients shall have nurses formally trained and experienced in the management of pediatric patients receiving cellular therapy. A current job description for all staff.
A system to document the following for all staff: Initial training and retraining when appropriate for all procedures performed.
Annual audit of verification of chemotherapy drug and dose against the prescription ordering system and the protocol. The Clinical Program shall establish and maintain policies and/or procedures addressing critical aspects of operations and management in addition to those required in B4. These documents shall include all elements required by these Standards and shall address at a minimum: Administration of HPC and other cellular therapy products, including products under exceptional release Labeling (including associated forms and samples) Equipment operation, maintenance, and monitoring including corrective actions in the event of failure.
Prior to administration of the preparative regimen, one (1) qualified person using a validated process or two (2) qualified people shall verify and document the drug and dose in the bag or pill against the orders and the protocol, and the identity of the patient to receive the therapy.
There shall be a policy addressing safe administration of cellular therapy products.
Two (2) qualified persons shall verify the identity of the recipient and the product and the order for administration prior to the administration of the cellular therapy product.
There shall be documentation in the recipient's medical record of the administered cellular therapy product unique identifier, initiation and completion times of administration, and any adverse events related to administration.  (Table 1.

2)
Senior staff should be aware that the patient's pathway, during the transplant process, can be unpredictable. There are episodes when the patient will experience complications of the treatment required for HSCT that will require a higher intensity of nursing care. During such episodes, the nursing management should have an established contingency plan to provide adequate nursing care for these patients. Possible options could be: • Nursing staff within the team allowed to work extra shifts • The employment of additional nursing staff with relevant experience from the hospital pool of nurses or from nursing agencies • Transfer of the patient to a high dependency or intensive care setting Whatever the contingency plan, there should be evidence in place, such as a written policy for staffing. This policy should describe the plan of action to be taken for small teams, apheresis, quality management and data collection teams, in case of planned or unplanned long-term absence from work, therefore allowing the patient's or donor's pathway to continue without affecting the nursing or medical care given.
Not only should there be adequate nursing staff, the nurses should be qualified, trained and competent in the roles they perform. JACIE can be a challenge and an opportunity for nurses in: • Reviewing existing procedures -Especially those that have been performed automatically in the same way despite being inefficient • In adopting measures for clinical risk management -Paying more attention to long-term planning for continuing education of personnel, procedures and tools for monitoring, verifying and in achieving competence maintenance • Development and implementation of internal audits and quality indicators Methods for collection shall include a process for controlling and monitoring the collection of cellular therapy products to confirm products meet predetermined release specifications.
Adequacy of central line placement shall be verified by the Apheresis Collection Facility prior to initiating the collection procedure.
Administration of mobilization agents shall be under the supervision of a licensed health care professional experienced in their administration and management of complications in persons receiving these agents. Furthermore, JACIE is an opportunity for nurse recognition within the organisation they work, in terms of contribution to the overall results achieved.

Training and Competencies
(Tables 1.2 and 1.3) All hospitals should have their own programme for training, annual review/appraisal and competencies. The structure already in place for recording the individual staff members training can also be used to record the JACIE Standards' requirements. A new system for training records for JACIE is not required if the following is undertaken.
• Basic training: -A route that leads to the skills acquisition in order to obtain new or improved "performance" • Educational training: -The set of activities, including basic training, aimed to develop and enrich the staff on the technical, special, managerial and cultural side aspects of their role • Competence: -The proven ability to use knowledge and skills • Competency maintenance: -The minimum activity that is required to be performed by each operator in order to retain the assessments defined in the specific job description. • Competency matrix: -The activities performed must be recorded in order to perform an annual assessment (quantitative and qualitative) for the activities that can be recognised.
It is important that training and competency programmes are structured and ongoing, with documented evidence of training topics and dates. Most importantly, an attendance register for training and competency sessions is required. Whilst initial supervised training is more easily documented, annual competency maintenance can be difficult to show ( Training needs to be flexible to reflect staff requirements and should be performed in a timely manner to demonstrate annual updating.
When staff cannot attend a particular training session due to staffing issues, holidays or sickness, a self-teaching system, e.g. an electronic system that includes the presentation and selfassessment tool, may be an option to consider.
For those centres that apply for a combined adult and paediatric JACIE accreditation, it is important that training sessions should include relevant age-specific issues for each topic, especially if the two age group populations are nursed within the same ward environment. Where adult and paediatric patients are nursed on separate wards, training sessions may be separate for certain topics, but it is also important to share sessions, where appropriate, to provide evidence that both population groups are an integrated part of a combined transplant facility.
The FACT-JACIE International Standards Accreditation requires that the clinical programme have access to personnel who are formally trained, experienced and competent in the management of patients receiving cellular therapy. Core competencies are specified within the standards, and evidence of training in these competencies must be documented. This may be achieved by evidence of in-service training, attendance at conferences, etc.
During September 2016, the EBMT (NG) in collaboration with JACIE and the EOC (Ente Ospedaliero Cantonale -multicentre Swiss hospital name, www.eoc.ch) launched the first video recorded course, aimed at physicians, nurses and technicians working within JACIE-accredited centres. The course focused on competency maintenance and could be accessed in person, on the day, or through online conferencing and is now a source of video recorded e-sessions, lectures and questionnaires, available online free of charge. Upon correct answering of questionnaires on every topic, participants to the in-site or online conference are able to obtain a Certificate of Competence that is validated by EBMT and JACIE that can be used as evidence towards the JACIE inspection. In addition, the activities were granted a CME certification by EBMT/EBAH and Swiss CME credits (The course is available at http://www.dsit.it/prj/ebmt2016/inex2.php). This initiative was based on an online test system using a SharePoint internal hospital standard operating procedures compliant with FACT-JACIE standards, developed by the Bellinzona transplant centre (Babic et. al. 2015).

Benefits of Quality
Management (Table 1.3) The key aim of the JACIE process is to implement a QMS into clinical practice. Despite the difficulties that maybe encountered, the process can be useful for integration of staff from all disciplines and professional collaboration. Staff education plays a key role in the implementation of the whole system and in particular for the quality management system (Piras and Aresi 2015). The majority of the quality standards are aimed at providing evidence that there are systematic processes in place. Furthermore, several of the standards relate to having systems in place to record initial qualification, training and competencies and minimal qualifications for the trainer.
The hospital system can be utilised for these standards, and this evidence can be shown to the inspectors. However, not all hospital record systems register the training qualification required by a member of staff who has a training role. (Table 1.

3)
Some nurses may be unfamiliar with this area. One approach is to view audits as assessing the care you give, reviewing the evidence and making changes to improve the patient's or donor's experience and/or nursing care given. After a predeter-mined period of time, it is necessary to reassess the changes made to measure any improvements resulting from those changes. This is referred to as "closing the audit loop". A nursing audit schedule works best when the nursing teams initiate the audit topics. It is important to include the audits required by JACIE, e.g.
(1) the verification of the chemotherapy drug and dose against the prescription and the protocol and (2) the verification of the haematopoietic stem cell infusion. It is important that the audit is performed by personnel that are not directly involved within the activity to be audited. (Table 1.

3)
To enable adverse events to be fully reported, it is important that a culture of "no blame" is present. The hospital should have an established reporting system in place, and it is important that the adverse events for transplantation and collection of cellular products including apheresis and marrow can be coded separately to other departmental adverse events. This allows for clarity and a true record of the number of events recorded for the transplant programme. Each episode is reviewed and changes made if required. This is then followed by an audit of the changes made to minimise a reoccurrence. Nurses working with patients and donors have a very important role in reporting adverse events. It is important that all adverse events are recorded in the quality meeting minutes, quarterly and annual reports and most importantly shared with all the sections involved in delivery of the transplant programme (clinical, collection and processing), as appropriate. For example, if a recipient has a reaction to a stem cell infusion or there is a deviation from the time specified for each infusion of thawed cells, these events should be reported and shared with the processing facility.
Where adverse events have been shared across departments, the inspector will require evidence that the events were discussed, and if any changes were made to practice that this was recorded, policies were updated and the episode monitored.

Tracking of Collected
Products (Table 1.3) To enable the safe collection, storage and distribution of collected products, it is important that each stage of the process is recorded. Therefore, collection, laboratory, transport and clinical staff should be involved in signing a transport log to accept the product and in some cases recording the temperature of the product. Policies should be in place to include what to do if there is a deviation in practice, e.g. temperature of the product falls outside the range of temperature agreed within the transport policy. It is important that policies and standard operating procedures that include responsibilities of more than one facility are shared and members of staff have ready access.
The donor and recipient's medical notes must be completed, as part of the tracking system, to record the collection or transfusion of the collected product. The cellular product identification, time and date should also be included in the medical notes

Common Deficiencies: 5th Edition of the JACIE Standards
During the annual meeting of the EBMT (2015), the results of a review of JACIE inspection reports against the 5th ed. of the JACIE Standards were presented (JACIE Quality Management 2015). The aim of the review was to identify common deficiencies within the standards. Of reports issued against the 5th ed. of the JACIE Standards, 95% (145/152) had been reviewed. Standards relating to clinical personnel were rated as the group of standards with the highest number of deficiencies. This was due to the lack of evidence: • In training and competencies for physicians • Relating to donor and recipient informed consent • Of diagnosis and management of graft versus host disease, both acute and chronic Other clinical standards that highlighted lack of evidence were related to the administration of the preparative chemotherapy regimen and the administration of the transplanted product. The inspectors could not find evidence that two personnel had checked the identity of the recipient against the dose of the material to be infused.
There were issues with quality management standards for clinical, collection and processing. Third-party agreements/service-level agreements failed to state the responsibilities of each facility involved within the process, e.g. who was responsible for transportation of the collected cellular product either from the collection facility to processing or transportation from processing to the clinical facility. For those clinical facilities that provide shared care for donors prior to collection of cellular material, it is important that third-party agreements/servicelevel agreements also include the responsibilities for the administration of mobilisation products. These responsibilities should be described within the appropriate standard operating procedure/policy (SOP), and it is important that all parties involved with the shared care have access to the SOP.
Labelling of collected products was a common issue, either non-compliance with the International Society of Blood Transfusion (ISBT128) standards for labelling or personnel failed to complete all the data fields on the label. Often the volume and name of the citrate used and start and completion time of the collection were missing.

JACIE: Implications on Nursing -The Nurse's Perspective
Research demonstrates that patient outcomes and donor care are improved (Anthias et al. 2016;Gratwohl et al. 2011) when treatment is delivered within a JACIE-accredited centre. Therefore, it could be assumed that the JACIE accreditation process has had implications on nursing practice. A literature search was performed (using PubMed and Google search engine with the following parameters: quality management, standard operating procedures, nurse education, JACIE accreditation and audit), but no results were found reflecting the dearth of nursing research on implications of JACIE for nursing. Therefore, a simple survey was sent to the members of the European Group for Blood and Marrow Transplantation Nurses Group (EBMT (NG)) via email. The aim of the survey was to establish what implications the JACIE process had for nurses in their daily practice.

Results of the Survey
The survey (in the form of a word document) was distributed via email to 322 nurse members of the EBMT nurses group (EBMT (NG). 135/322 (41%) nurses opened the email received and the response rate was 31/322 (9.62%). One reply was rejected due to the transplant centre not working towards JACIE accreditation; therefore 30/322 (9.3%) replies from 11 countries were evaluated: Nurses who responded to the survey performed a variety of roles within the area of HSCT, worked in 11 different countries, and their replies varied from "no implications on daily routine" to "nurses obtaining new skills in areas such as developing standard operating procedures and risk management".

Results
A total of 322 EBMT (NG) members were contacted via email with a response rate of 9.62% (31 replies) from 12 countries. One reply was rejected due to the transplant centre not working towards JACIE accreditation therefore 30 replies from 11 countries were evaluated: The role, seniority and the involvement of the nurse, in the JACIE process, could have an influence on how each respondent responded.
97% (29/30) of respondents were classified as senior nurses: Seven ward managers Fourteen* clinical nurse specialists (CNS) Five quality managers Three nurse coordinators One nurse consultant responsible for SOPs in clinical and processing facility 3% (1/30) of respondents were classified as a staff nurse/junior nurse. *One CNS role includes data manager and one CNS is responsible for JACIE The majority of nurses, 93.3% (28/30), worked within the clinical area**, 3.3% (1/30) worked in the apheresis facility and 3.3% (1/30) within the processing facility. **Two clinical nurses worked in a second area (one in apheresis and one in processing)

Implications: Staff Nurse's/ Junior Nurse's Point of View
The only staff nurse/junior nurse to respond to the questionnaire described their role, instead of describing any implications that had occurred in working towards their first JACIE accreditation: "Nurses were involved in checking procedures, therefore providing documented evidence in education and patient care". This is a good demonstration that all staff within the transplant programme should be involved in the accreditation process.

Implications: Ward Manager's Point of View Can Be Summarised as Follows
JACIE has provided an improved structure to produce written procedures, which are reviewed regularly. This uniform working allows procedures to be described precisely, enabling all staff performing the procedure to perform the task in the same way and can be used an educational tool especially for new members of staff. The experience of JACIE has improved patient care, improved communication between all members of the team and has allowed for a closer working relationship. Nurses were able to learn new skills especially in understanding risk management.

Implications: Clinical Nurse Specialist's Point of View Can Be Summarised as Follows
Initially the documentation and developing the JACIE programme took many years and was hard work. Extra work had to be incorporated into a busy schedule, and time had to be allocated to attend the many meetings relating to JACIE. Now accreditation has been achieved, and the team works within an established programme. All the effort was worthwhile because everyone feels confident with the quality standards and programme. Quality is always a priority. Additional management hours were required to administer/manage the increased numbers of protocols and procedures. New presentation skills were learnt in presenting audit results to the transplant team, and new opportunities arose to develop a donor care programme to conform to the JACIE Standards.
There was only one negative feedback: "Unfortunately no impact on daily practice".

Implications: Quality Manager's Point of View Can Be Summarised as Follows
The transplant team now has a greater awareness and importance of standard operating procedures (SOPs) by working within a document controlled system and being included in the multidisciplinary team meetings. Within the paediatric setting, there has been an improvement in medical SOPs for the care of the HSCT paediatric patients as well as an improvement in collaboration with the adult clinic, apheresis and stem cell laboratory teams. Patient outcome reviews have been valuable in improving care. The JACIE audit programme has encouraged the transplant team to perform internal audits, which has led to improvements in quality assurance.

Implications: Nurse
Coordinator's Point of View Can Be Summarised as Follows JACIE has highlighted more attention is required for nurse training, evaluation of competencies, document control and the registration process. The standards relating to donors has emphasised to the team the importance of the role of a "donor advocate", to prevent a conflict of interest of the transplant physician, and JACIE is a very useful working tool, especially for new colleagues.

Conclusion of the Survey
Although there was a very low response to the survey (9.62%), the results represent the views of senior nurses (97% of respondents). After reviewing the 45* comments from the 30 respondents, the authors of this survey would like to suggest that the JACIE accreditation process has had a positive impact on nurses. Only 9% of comments could be classified as having a negative impact on the nurse due to extra workload. * See Appendix 1.1 for a full list of citations written by the respondents to the survey.
A further study is required within the BMT nursing community to fully understand the implications for nurses during the initial JACIE accreditation phase and post JACIE accreditation whilst maintaining and improving the quality system that is now embedded into daily practice. The study could be based on the Donabedian model looking at structure, process and outcomes.
The JACIE Standards are reviewed every 3 years, allowing them to be adapted to the rapidly developing field of HSCT. Nurses are required to maintain compliance with the QMS and JACIE Standards and must familiarise themselves with the changes that occur in each edition of the JACIE Standards. Each edition will present fresh challenges to achieve the standards especially given the present day competing pressures on resource and finance. It is noteworthy that none of the surveyed nurses mentioned this aspect as a concern for nurses in their practice. As nurses working within JACIEaccredited centres, it is important to provide evidence of our continued monitoring of practice and processes through the QMS and not regard the JACIE accreditation process as a tick box exercise.

Discussion Points
Since the introduction of JACIE accreditation, nurses have submitted oral and poster presentations at the annual EBMT (NG) conference on the topic "Preparing for JACIE". The small response to our EBMT (NG) survey and a literature search that could not identify published articles on the topic of "JACIE and implications for nurses" could suggest the JACIE accreditation process has not impacted greatly on nurses.
One of the five Deming principles (Health Catalyst 2014) that help health-care process improvements: "Quality improvement is a science of process management. If you cannot measure it you cannot prove it, therefore quality improvement must be data driven".
As specialised nurses, working in the field of HSCT, we should be asking ourselves why are we not publishing our data or audit findings. Using the development of the apheresis collection services across Europe as an example, many teams will be nurse led. When the collection of HSCs became an established practice, the number of nursing teams increased, training became more formalised and apheresis nurse forums were established to try and reinforce policies and procedures. A QMS was introduced in the form of JACIE accreditation with risk management and audit became integral to the apheresis nurse role.
Deming also states:" If nurses are going to manage care, they require the right data delivered in the right format at the right time and in the right place". Therefore, nurses with the HSCT programme should take ownership, perform audits, assess the results, make changes to patient care and reassess. These experiences and findings should be shared and published.
If the reluctance to publish is a lack of ownership of quality management, or nurses perceive quality management as the responsibility of the quality manager, then they must be reminded that JACIE has a significant impact upon each and every role and that they must be aware and fully participate in the process. Audit, review of policies and procedures, competencies and risk assessment will become a key part of the nursing routine for the QMS to be maintained and to evolve. • Patient safety is highlighted.
• All nurses are working in a more quality assured way, by only using adequate and current documents and working procedures. • The internal audits, which we have performed for several years, whilst working with JACIE, have led to improvements in quality assurance. • Before JACIE accreditation, we actually did not have strict medical SOPs for treatment of our paediatric transplant patients. • Since first accreditation as a separate paediatric centre, we have broadened our corporation with the adult clinic, apheresis and stem cell lab. Since then SOPs are more in common. "Nurses are now involved and appreciate being involved in the review meeting for patient outcome". Citations classed as neither negative nor positive: • More SOPs to write • Increased audits • Working with documents and internal audits • Updating SOPS, ensuring staff, including the multidisciplinary team, understand the importance of following the SOP

Nurse coordinator's and nurse consultant citations
Citations classed as positive: • Separate donor and recipient management.
• JACIE is a good working tool, especially for new colleagues. Citations classed as neither negative nor positive: • More attention in the control of the working activities. • More attention in the registration of processes. • More attention in the nurse training and evaluation of competency. • My mission is to work for the HSCT programme of quality programme improvement process as required by the accreditation body JACIE.
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