New premises inspection report The Peninsular Centre for ... · Peninsular Centre for Reproductive Medicine Page 2 of 15 New Premises Report 2009-04-09 About the Inspection: This

Peninsular Centre for Reproductive Medicine Page 1 of 15 New Premises Report 2009-04-09

New premises inspection report

The Peninsular Centre for Reproductive Medicine

0005

Date of Inspection: 8th April 2009 Date of Licence Committee: 20th April 2009


About the Inspection: This inspection visit was carried out on Wednesday 8th of April 2009. The purpose of the inspection is to ensure that the Peninsular Centre for Reproductive Medicine (PCRM) has premises and facilities in which a quality service for patients in compliance with the HF&E Act 1990, Code of Practice and EU Tissue and Cells Directive 2004/23/EC can be provided The report summarises the findings of the premises and facilities inspection highlighting areas of good practice, as well as areas where further improvement is required in order to meet regulatory requirements. It is primarily written for the Licence Committee who makes the decision about the centre’s application. The report is also available to patients and the public following the Licence Committee meeting. Where recommendations are made the HFEA will provide details of what needs to be addressed but not how they should be carried out as this is the responsibility of the Person Responsible. The report includes a response from for the Person Responsible to complete following the inspection. The HFEA welcomes comments from patients and donors, past and present, on the quality of the service received. A questionnaire for patients can be found on the HFEA website www.hfea.gov.uk .


Centre Details Person Responsible

Jonathan West

Nominal Licensee PCRM Ltd

Centre name The Peninsular Centre for Reproductive Medicine

Centre address

Peninsular Centre for Reproductive Medicine, Royal Devon & Exeter Hospital (Heavitree), Gladstone Road Exeter Devon, EX1 2ED United Kingdom

Centre number

0005

Type of inspection

New premises

Inspector(s) Ellie Suthers Stephanie Gadd

Fee paid N/A

Licence expiry date

28/02/2014

NHS/ Private/ Both

Private


Index About the Inspection: ..........................................................................................2

Centre Details .....................................................................................................3

Index ...................................................................................................................4

Brief Description of the Centre............................................................................5

Activities of the Centre for the time period 2007 .................................................5

Summary for Licence Committee 6

Premies and Equimpment...................................................................................7

Photographs of the facilities 10

Floor Plans........................................................................................................12

Appendix C: Response of Person Responsible to the inspection report ..........15


Brief description of the Centre and background to inspection The Peninsular Centre for Reproductive Medicine (PCRM) is a medium sized assisted conception unit providing approximately 300 licensed treatment cycles per year. The centre has been licensed by the HFEA since 1992. There is a satellite link with a fertility centre Wheal Unity Clinic, Truro, Cornwall. This inspection and report focussed on the new premises and facilities only. The onsite inspection demonstrated regulatory compliance with premises and facilities’ requirements. Subsequently the PR has provided documented evidence of environmental and critical equipment regulatory compliance. The clinic’s laboratory, theatre and recovery facilities have been relocated from the main hospital theatre complex into refurbished facilities in the main clinic area: clinic facilities have been extended to accommodate expansion in cycle numbers. All other parts of the premises remain unchanged and appropriate for licensed activity. (Licence renewal inspection November 2008) The extension and refurbishment of the new facilities has been delayed and this led to the centre being moved out of the existing laboratory, operating theatre and recovery area at short notice. At the time of inspection Trust facilities were no longer available to PCRM and all activity has ceased. At the time of inspection the proposed new laboratory premises had been refurbished, deep cleaned and handed over to the centre staff but no equipment had been moved over or installed. Following the handover of premises on 8th of April 2009 and subsequent to the inspection, the staff moved all equipment and materials into the new facilities between 9th and 17th of April 2009. The PR has ensured that the centre has the resources needed for licensed activity in terms of personnel, facilities, equipment and material, and data and information systems. (CoP S.6.1.1) There has been no change to treatments, standard operating procedures, training or staffing requirements as a result of the refurbishment and relocation.

Activities of the Centre1 for the time period 2007 In vitro fertilisation (IVF) & Intra cytoplasmic sperm injection (ICSI)

274

Frozen embryo transfer (FET) 31 Donor insemination 19 Storage gametes/embryos ��

1This data is supplied to the HFEA by individual clinics who are responsible for its accuracy and for verifying it.

The data published by the HFEA is a snapshot of the state of the Register at a particular time. The data in the Register may be subject to change as errors are notified to us by clinics, or picked up through our quality management system


Summary for Licence Committee Following the onsite inspection the PR provided documented evidence of successful re commissioning and recalibration of critical equipment and regulatory compliance with air quality requirements. An emailed copy (from the PR’s email address) of the Appendix C PR Response is added as part of this report. A signed copy has been mailed to the HFEA. 1) The inspectorate recommends that the Peninsular Centre for Reproductive Medicine’s licence is varied to include the new premises and facilities. 2) The executive requests that the Licence Committee expedites the approval of the minutes for this agenda item and communicates its decision to the executive and the PR as soon as possible.


1. Premises and Equipment Desired outcome: The premises and equipment are safe, secure and suitable for their purpose. Summary of the findings from the inspection of the following areas of practice: • Premises • Clinical facilities • Counselling facilities • Laboratory facilities • Air quality • Management of equipment and materials • Storage facilities for gametes and embryos • Staff facilities • Storage of records

Areas of firm compliance Premises refurbishment: The following additions have been made to the main centre facilities: � IVF laboratory; � seminology laboratory area annexed to the main cryo store; the existing cryo store has

been enlarged to encompass the adjacent room � theatre for egg collections; � four bed recovery bay; � sperm production room; � consulting room; � patient changing area. The new facilities have a new air conditioning/filtration plant, and wall, floor and ceiling coverings specifically designed for use in IVF laboratories. Security of premises: The premises retain the existing security measures. Gametes and embryos are stored in a designated security area with controlled access. Access to the security area is by authorised personnel and a monitoring system is in place to ensure high standards of security. (CoP S. 6.3.8) All access to laboratories, clinical and treatment areas are via lockable doors with swipe card access. Management of equipment and materials: Equipment and materials were moved from the existing licensed location in the Trust operating theatres and laboratories into the new facilities subsequent to the inspection. Documented evidence of re commissioning and recalibration of critical equipment has been provided to the inspectorate. The results demonstrate for regulatory compliance. The centre has an existing policy and procedure in place to facilitate this process.


Additional equipment: The following additional equipment has been purchased: � 1 incubator � 1 centrifuge � 1 laminar flow hood with integral stereomicroscope and heated stage � 1 seminology microscope � air conditioning plant with supplementary IVF air filtration units � additional alarm circuitry, including incubator alarms � medical gas pipe work The following evidence of suitability of the new premises was provided at the time of inspection: � Compliance with building regulations certification (Building Act 1984) signed 7th April 2009 � Certificate of compliance Water regulations Advisory Scheme signed March 31st 2009 � Completed deep clean of fertility areas and adjoining rooms signed 5th of April 2009 � Health and Safety assessment: Carried out by the Royal Devon and Exeter Foundation

Trust. Signed 7th April 2009 � Infection control sign off by the Royal Devon and Exeter NHS Foundation Trust infection

control services; � Fire and Safety certification by the Royal Devon and Exeter NHS Foundation Trust health

and safety services. Risk assessment of refurbished premises: The following areas were risk assessed following refurbishment: main access corridor, cryo store and seminology laboratory, senior scientists’ office, main scientists’ office, semen sample production room, disabled toilet, staff changing room, procedures theatre, sluice area, laboratory area, nurse station, patient recovery area. Each area generated no more than minor and unlikely risk scores according to the centres risk tool. Clinical treatment and patient recovery areas have equipment and emergency equipment as required for licensable activity. The centre staff have carried out a “dry run” of a patient journey/egg collection in order to anticipate any possible difficulties either in the clinical or laboratory areas. The PR has carried out a risk assessment and has provided documented evidence that no significant hazards have been identified. Air Quality: Air quality is monitored continuously and the embryologist provided documentation that demonstrated compliance with air quality requirements in the laboratory environment before and after all equipment had been moved in and the laboratory prepared for use. (CoP A.10.19) Clinical facilities: The new clinical facilities consist of a new consulting room and a four bay recovery area that appeared to be appropriate for the activities for which the centre is licensed. Patient treatment will be delivered using existing compliant policies and protocols. Staff do not require extra or further training as a result of the move in premises. Clinical facilities including sperm production rooms ensure patient/donor privacy and dignity is maintained and are appropriate for centre activities. (CoP S 6.3.4&3)


Storage facilities for gametes and embryos: The facilities for the storage of gametes and embryos have not changed since the last inspection and remain appropriately sized, secure and with restricted access. (CoP S.6.3.8 (a):S.6.3.8) Laboratory facilities: The new laboratories provide for seminology and IVF activities and are located next to the theatre/treatment room via a “barn door” arrangement. There is a hatch from the sperm production room through to the laboratory. The arrangements appear to be suitable for licensed activity. (CoP S.6.3.6) Areas for improvement Areas for consideration Executive recommendations for Licence Committee Following the onsite inspection the PR has provided all requested documented evidence regarding the following:

� Re commissioning and recalibration of critical equipment moved from the existing licensed location in the Trust operating theatres and laboratories into the new facilities was to be carried out subsequent to the inspection. Following the onsite inspection the PR provided documented evidence of successful re commissioning and recalibration of critical equipment.

� At the time of the inspection, air quality had been monitored and was compliant with

HFEA requirements but the facilities were not equipped. Subsequently the PR has provided documented evidence of air quality compliant with regulatory requirements. (CoP A.10.19)


Photographs of the new facilities �

Laboratory: �

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Laboratory:

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Recovery area: �

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Treatment room: �



Appendix B: Licence history for previous 3 years 2008 05/11/09 Renewal inspection – New Licence issued with no conditions (28/02/2014) 2008 17/01/08 Interim Inspection – continuation of licence with no conditions 2007 16/10/07 Interim Inspection – continuation of licence with no conditions 26/04/07 Licence Committee approved an application to vary the centres licence in accordance with the requirements of the EU Tissue and Cell Directive 2006 15/08/06 Interim inspection – continuation of licence with no conditions


Appendix C: Response of Person Responsible to the inspection report Centre Number………0005……………………………………………………… Name of PR…………Mr Jonathan West ………………………………………… Date of Inspection…8th April 2009……………………………… Date of Response…17th April 2009 ……………………………………………… I have read the inspection report and agree to meet the requirements of the report. Signed………………………………………………………………………………… Name…………………………………………………………………………………… Date……………………………………………………………………………………… 1. Correction of factual inaccuracies Please let us know of any factual corrections that you believe need to be made. We will make alterations to the report where there are factual inaccuracies. As can be seen from the photos the positioning of some of the laboratory equipment differs slightly from the original design schematic. 2. Please use the space below to document any comments or additional information that you would like to be considered by a Licence Committee.

The refurbishment is a consequence of a need to expand and an urgent need for the Trust to use the space occupied by our existing facilities. Building problems (principally previously undiscovered asbestos) led to delays in the programme as a consequence of which we have had to reschedule some patients. They have been very understanding but further rescheduling would cause some distress and disruption and an early communication of the Licensing Panel’s decision and approval to use the premises (if approval is granted) would be very much appreciated.


3. Please state any actions you have taken or are planning to take following the inspection with time scales

Documents

New premises inspection report The Peninsular Centre for ... · Peninsular Centre for Reproductive Medicine Page 2 of 15 New Premises Report 2009-04-09 About the Inspection: This