Anatomy Standards And Guidance - Human Tissue Authority

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Anatomy Licensing Standards andGuidanceRevision history . 2About the guidance documents . 3About the Standards. 3Consent (C). 4Governance and quality systems (GQ) . 4Traceability (T) . 4Premises, facilities and equipment (PFE) . 4Guidance on the Standards. 5Consent Standards . 5Governance and quality system Standards . 6Traceability. 12Premises, facilities and equipment Standards . 13Classification of the level of shortfall . 16Critical shortfalls. 16Major shortfalls. 16Minor shortfalls. 171

Revision historyVersion1.0Date23/01/2016ChangesFirst version published2

About the guidance documents1.The purpose of these guidance documents is to assist licensed establishmentsto meet the HTA’s licensing standards. The documents contain additionalinformation and examples of how to meet certain Standards.2.These documents will be reviewed regularly to include additional guidance. Inreviewing these documents, we will take into consideration enquiries,inspection findings and additional examples of good practice.3.For further guidance on meeting the HTA’s standards, please contact the HTAeither by:a) Email: Telephone: 020 7269 1900About the Standards1. In order to obtain an HTA licence, the applicant must demonstrate that:a) the premises where the activity will take place are suitable; andb) the proposed Designated Individual is a suitable person to supervise theactivity.2. As part of the application process, the HTA will assess whether the establishmentcan meet a number of licensing Standards. These were developed in consultationwith representatives from the Anatomy sector. These relate to the consentprovisions of the Human Tissue Act 2004 (HT Act), governance and qualitysystems, traceability and premises.3. The Standards reinforce the HT Act’s intention that:a) consent is paramount in relation to activities involving the removal,storage and use of human tissue;b) bodies of the deceased and organs and tissue removed from bodies aretreated with respect;c) the dignity of the person, whether living or deceased, is maintained.4. The HTA works with establishments through its inspection process to help themcomply with these Standards.5. The Standards are grouped under four headings: Consent (C); Governance andquality systems (GQ); Traceability (T); and Premises, facilities and equipment(PFE). Under each of these headings, there are overarching statements, fromwhich the standards flow.3

Consent (C)4. Establishments meeting the consent Standards will be able to demonstrate thattheir processes for seeking and gaining consent comply with the HT Act and theHTA’s Codes of Practice. The Standards also cover the documentation andinformation used to support the establishment’s consent procedures, and ensurethat staff involved in seeking consent are suitably trained and equipped for thetask.Governance and quality systems (GQ)5. Establishments meeting these Standards will be able to demonstrate that theyhave a suitable governance framework, underpinned by clear and controlleddocumentation, effective audit, staff training and organised record-keeping. Inaddition, they will have an effective system of risk management and suitablesystems to deal with adverse events.Traceability (T)6. Establishments meeting these Standards will be able to demonstrate fulltraceability for the human material for which they are responsible, from receipt tofinal disposal/disposition. HTA inspectors will test this through traceability auditscarried out on site and we expect establishments to take a pro-active approach toassuring themselves of effective traceability throughout the lifetime of theirlicence. In addition, as the final traceability step, they will have establisheddisposal arrangements which are in accordance with the HTA’s Codes ofPractice.Premises, facilities and equipment (PFE)7. Establishments meeting these Standards will be able to demonstrate that theirpremises and facilities are appropriate for their licensed activities and are safe,secure and clean. In addition, establishments will have systems for on-goingmonitoring to ensure all key quality specifications are maintained. TheseStandards also cover equipment, ensuring that it is appropriate, and suitablymaintained, and that it does not present an impediment to the staff using it.8. The HTA licensing Standards which will be applicable to the Anatomy sector fromApril 2017 are included at Annex B and on the HTA website. The Standards aresupported by comprehensive guidance notes.4

Guidance on the StandardsConsent StandardsC1 Consent is obtained in accordance with the requirements of the HumanTissue Act 2004 (HT Act) and as set out in the HTA’s Codes of Practicea) Consent procedures are documented and these, along with any associateddocuments, comply with the HT Act and the HTA’s Codes of Practice.b) Consent forms are available to those using or releasing relevant material for ascheduled purpose.c) Where applicable, there are agreements with other parties to ensure that consentis obtained in accordance with the requirements of the HT Act and the HTA’sCodes of Practice.GuidanceWhere establishments receive specimens from other organisations, they musthave agreements in place to ensure that consent is obtained in accordance withthe regulatory requirements. These agreements should be reviewed periodicallyto ensure that material is used, handled, stored, transported, and disposed of inaccordance with the donors’ wishes and the consent given.d) Written information is provided to those from whom consent is sought, whichreflects the requirements of the HT Act and the HTA’s Codes of Practice.GuidanceIt is important that information used to support the seeking of consent coverswhat is needed for potential donors to make informed decisions. This means allanticipated uses for donated material is covered, such as surgical training andthe making of images.Although taking photographs of human material is not covered by the HT Act, ifan establishment intends to allow photographs to be taken of specimens tofacilitate training, it is good practice for this to be included in the consentinformation. A number of establishments include this in their bequeathal, processand strictly control any photography in accordance with the consent obtained.e) Language translations are available when appropriate.f) Information is available in formats appropriate to the situation.GuidanceEstablishments should ensure that the consent process provides full informationto donors in a variety of suitable formats. For example, the fonts used inbequeathal booklets and consent forms should be clear and of an appropriate5

size to be easily read.General guidanceWe have published model consent forms for body donation for anatomicalexamination, which can be found on our website. A number of establishmentsuse these model consent forms as the basis for their own consent forms.C2 Staff involved in seeking consent receive training and support in theessential requirements of taking consenta) There is suitable training and support of staff involved in seeking consent.b) Records demonstrate up-to-date staff training.c) Competency is assessed and maintained.General guidanceIt is important that consent training is not considered a one-off event and thatproficiency in seeking consent is upheld.There is no set requirement for the frequency of consent training. Consentseekers are expected to maintain awareness of current standards throughreference to published guidance and relevant policies. Training may need to beupdated when new policies or practices have been implemented.Governance and quality system StandardsGQ1 All aspects of the establishments work are governed by documentedpolicies and procedures as part of the overall governance processa) Ratified, documented and up-to-date policies and procedures are in place,covering all licensable activities.GuidanceAt a minimum, it is expected that most establishments will have standardoperating procedures (SOPs) covering the following activities: consent;receipt;labelling;specimen preparation / preservation;storage;6

relevant transport arrangements;cleaning and decontamination; disposal.An SOP should be a clear and accurate representation of an existing procedureor process, preferably set out in the format of a stepwise guide. SOPs should beunderstandable to enable new staff to follow a procedure from beginning to end.They should be detailed enough to ensure uniformity between staff in theperformance of a specific function and should be followed to the letter by all staffwho have been appropriately trained.People undertaking the processes should be involved in developing the SOPs toensure that the written procedures reflect actual practices; however, the author ofan SOP should not also be the only person who reviews it. Regular review ofSOPs will help to prevent incremental departure from written processes withpassing time and allow establishments to identify improvements. Establishmentsshould introduce a system to record that staff have read and understood SOPs.b) There is a document control system.GuidanceGovernance documents should include: revision history and version number;effective from’ date;review date (at least every three years);pagination;author and reviewer names.c) There are change control mechanisms for the implementation of new operationalprocedures.GuidanceChange control mechanisms should take into account the risks of any plannedchanges, any validation required, any training required and how implementedchanges will be reviewed.d) Matters relating to HTA-licensable activities are discussed at regular governancemeetings, involving establishment staff.GuidanceAll staff working under the HTA licence should be aware of the governancearrangements in place, and they should be represented at governance meetings.Overall governance processes should be supported by regular meetings withstaff at the establishment who are engaged in licensed activities. Formal7

meetings should be minuted and the actions should be noted and followed up.Documented minutes of meetings should be distributed to all relevant staff to helpto ensure that they are aware of all important information relating to licensedactivities at the establishment. National and local information relevant to activitiesshould also be disseminated.e) There is a system for managing complaints.General guidanceA formal quality management framework helps to establish minimumexpectations for governance and quality systems, and facilitates continuousimprovement.The work of the staff at the establishment must be subject to a system ofgovernance. This means that there should be clear reporting lines andaccountability (particularly with regard to individual staff and the DesignatedIndividuaI), documented roles and responsibilities.Establishments are encouraged to have an over-arching quality document whichprovides an overview of the establishment’s main purpose, organisation andstructure and approach to governance and quality. This document should beaccessible to all staff involved in licensed activities.GQ2 There is a documented system of audita) There is a documented schedule of audits covering licensable activities.b) Audit findings include who is responsible for follow-up actions and the timeframesfor completing these.General guidanceAudits will demonstrate compliance with HTA standards and demonstratewhether establishments are meeting the requirements of their own systems. Adocumented schedule of audits should be in place at each establishment. Verticalaudits of records and specimens will allow the establishment to assure itself thatspecimens and records are fully traceable from consent to disposal. Records,including records of consent, should be audited regularly to ensurecompleteness, accuracy and legibility.Audits should ideally include horizontal audits by staff involved in the processes,to ensure that SOPs accurately reflect actual practices and to identify areas forimprovement. All audit findings and related corrective and preventative actionsshould be recorded to allow the establishment to demonstrate compliance withHTA Standards and follow-up outstanding actions.Audit processes can benefit from being undertaken by a person who is not8

normally involved in the activity at the establishment: a ‘fresh eyes’ view. Internalauditors should not be involved in auditing their own work.Some establishments may be able to make use of existing in-house expertise orservices.GQ3 Staff are appropriately qualified and trained in techniques relevant to theirwork and are continuously updating their skillsa) Qualifications of staff and all training are recorded, records showing attendanceat training.b) There are documented induction training programmes for new staff.c) Training provisions include those for visiting staff.d) Staff have appraisals and personal development plans.General guidanceTraining and induction packages help to ensure that staff are fully trained on allpolicies and procedures relevant to their work. Establishments should ensure thattraining and development plans are in place and that these are reviewedperiodically.Staff should be encouraged to attend professional meetings and training eventsto ensure that they keep abreast of good practices in their areas of expertise.GQ4 There is a systematic and planned approach to the management ofrecordsa) There are suitable systems for the creation, review, amendment, retention anddestruction of records.GuidanceDocumented records are used by establishments to evidence traceability andensure a robust audit trail. In this context, traceability refers to the completenessof auditable information about every step in the pathway for the use of relevantmaterial, from consent through to disposal, or the material has been used upentirely.Documented procedures for the creation, review, amendment, retention anddestruction of records are required to help to ensure that records are maintainedappropriately. SOPs should detail the frequency of document review required toensure that documents are regularly reviewed and updated as necessary.9

b) There are provisions for back-up / recovery in the event of loss of records.GuidanceRecords may be in various formats, including paper based, electronic, or storedon recordable media.A centralised system for the storage of records can help to ensure that recordsare regularly backed-up.c) Systems ensure data protection, confidentiality and public disclosure (whistleblowing).GuidanceConsideration must be given to other relevant legislation, including compliancewith the Data Protection Act 1998 where tissue has been taken from the living,and compliance with professional guidelines where applicable.GQ5 There are systems to ensure that all adverse events are investigatedpromptlya) Staff are instructed in how to use incident reporting systems.b) Effective corrective and preventive actions are taken where necessary andimprovements in practice are made.General guidanceAll establishments licensed by the HTA are required to have an internal systemfor reporting adverse events and, where necessary, instigating an investigation orroot cause analysis.Clearly assigning responsibilities for incident management is important. As the DIis responsible for licensed activities at the establishment, there should be aprocess in place to allow them to be made aware of adverse events so thatproper investigation and reporting can take place. There should be an adverseincident SOP detailing how adverse incidents are logged, reported, addressedand monitored.Although there is currently no requirement for establishments in the anatomysector to report adverse incidents to the HTA, if a DI has concerns about anadverse event, they are encouraged to contact us for further advice.Examples of adverse events include: loss of dignity of the deceased (security breaches, interference with abody,unconsented photography of a body, damage to a body through a lapse incare);10

incorrect disposal;body parts/cadaver/ prosection loss;incomplete records;fridge/freezer warming or breakdown.GQ6 Risk assessments of the establishment’s practices and processes arecompleted regularly, recorded and monitoreda) There are documented risk assessments for all practices and processes requiringcompliance with the HT Act and the HTA’s Codes of Practice.GuidanceAll establishments should identify the risks inherent in the key activities, andprocedures should be developed in consideration of and to mitigate thesepotential risks where appropriate. Establishments may tend to focus riskassessments on health and safety issues which, in themselves, are not sufficientto meet our Standards. DIs should also assess the risks associated with licensedactivities. Documented risk assessments should include an evaluation of the levelof the risk and, where appropriate, the mitigating actions identified and the levelof residual risk remaining.Risk assessments should include the risks relating to the premises, practices andprocedures connected with licensed activities, including: loss of or damage to specimens;loss of traceability;receiving specimens without appropriate consent documentation;storage of anatomical specimens and contingency arrangements;transport of specimens to and from the establishment;security arrangements.b) Risk assessments are reviewed regularly.GuidanceRisk assessments should be reviewed periodically (typically, every 1-3 years)and the actions to mitigate risks updated as necessary.Risk assessments should also be reviewed following an incident.c) Staff can access risk assessments and are made aware of risks during training.GuidanceBy documenting risk assessments, staff are made aware of identified risks, whichhelps to prevent risks materialising and informs the development of proceduresand relevant documentation.11

TraceabilityT1 A coding and records system facilitates the traceability of bodies andhuman tissue, ensuring a robust audit traila) There is an identification system which assigns a unique code to each donationand to each of the products associated with it.b) A register of donated material, and the associated products where relevant, ismaintained.c) An audit trail is maintained, which includes details of when and where the bodiesor tissue were acquired, the consent obtained, the uses to which any materialwas put, when and where the material was transferred, and to whom.d) A system is in place to ensure that traceability of relevant material is maintainedduring transpo

with representatives from the Anatomy sector. These relate to the consent provisions of the Human Tissue Act 2004 (HT Act), governance and quality systems, traceability and premises. 3. The Standards reinforce the HT Act’s intention that: a) consent is paramount in relation to activities involving the removal, storage and use of human tissue; b) bodies of the deceased and organs and tissue .

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