Andrology User Manual Liverpool Women`s Hospital
Contents
1. f some of the sample was lost during collection please inform a member of the laboratory staff SECTION 4 TO BE COMPLETED BY STAFF RECEIVING SAMPLE confirm that the paperwork belonging to the patient named above was handed to me at the time specified below and the patient s details have been verbally confirmed Signature of staff member receiving paperwork Time sample received Date confirm that have received the sample from the patient named above and that the sample was appropriately labelled Signature of staff member receiving sample Time sample received Author SB Owner KS Page 15 of 15 Uncontrolled when photocopied Do not use after review date2. OUT UNDER ANY CIRCUMSTANCES 13 TURNAROUND TIME The Andrology Laboratory endeavours to return results within 2 weeks of patient attendance 14 PROVISION OF CLINICAL ADVICE COMPLAINTS Clinical advice on any aspect of the diagnostic or therapeutic services provided by the Andrology Laboratory can be obtained from Dr Stephen Troup Scientific Director 0151 702 4173 Dr Iwan Lewis Jones Consultant Clinical Andrologist 0151 702 4215 Andrology Laboratory 0151 702 4214 Or by e mail enquiry to stephen troup Iwh nhs uk Karen schnauffer glwh nhs uk Complaints should be directed to the Quality Manager or Scientific Director at the Hewitt Fertility Centre Liverpool Womens Hospital Crown Street Liverpool L8 7SS ISO 15189 2012 4 8 15 MEASUREMENT OF UNCERTAINTY ISO 15189 2012 5 5 1 3 5 5 1 4 5 5 3 Clinicians and scientists are generally comfortable with the concept of uncertainty in relation to a blood test to determine for example a hormone level but of course a semen analysis comprises a combination of different test results As such it is important to consider the measurement of uncertainty in relation to semen analysis testing and the mechanisms that are in place to attempt to minimise uncertainty of measurement when assessing semen samples Therefore we have produced a document SCI POL 1 Measurement of uncertainty in Semen analysis that we ask that you read It includes a section at the back with bullet points that you are asked
3. Owner K Schnauffer Author S Brooks Presence of agglutination A qualitative assessment of the numbers of sperm sticking to each other Reported as 1 2 3 or 4 1 being minimal agglutination and 4 being the majority of sperm are agglutinated Sperm viability Percentage of viable sperm only measured if sperm motility lt 90 10 EXAMINATION OF POST VASECTOMY SAMPLES The guidelines issued by the British Andrology Society for the examination of post vasectomy semen samples are followed throughout P Hancock amp E McLaughlin for the British Andrology Society 2002 J Clin Path p812 816 All samples in which very low numbers of sperm are observed or samples in which no sperm are observed on initial microscopic examination will be subjected to centrifugation concentration and further examination By concentrating the sample the sensitivity of the analysis in terms of the ability to observe sperm is increased 10 50 fold It is also then possible to examine the entire ejaculate The Andrology Laboratory will report any observations including the presence of very low numbers of immotile sperm When greater than 50 non motile sperm seen on wet prep a concentration will be performed to assist the clinician on giving special clearance It is left to the clinical judgement of the referring clinician to deem patients fertile or infertile on the basis of semen analysis results although clinical advice will
4. Tel Fax The Hewitt Fertility E Document Code QMS AND UM 4 Document Title Andrology Diagnostic User Manual Livepool Womens Hospital Version No 3 Date of issue 16 07 2015 Date of review 16 07 2016 Hewitt Fertility Centre Owner K Schnauffer Author S Brooks 1 INTRODUCTION This manual describes the policies procedures and repertoire of the Andrology Laboratory The Hewitt Fertility Centre at Liverpool Women s Hospital This department is manned by dedicated staff on a full time basis We work towards the standards outlined by WHO 2010 Examination and processing of human semen and ISO 15189 2012 Medical laboratories Requirements for quality and competence 2 CONTACT DETAILS The postal address of the Andrology Laboratory is Andrology Laboratory Hewitt Fertility Centre Liverpool Women s Hospital Crown Street Liverpool L8 7SS 0151 702 4214 0151 702 4152 The Andrology Laboratory is under the direction and management of Dr Stephen Troup Scientific Director ISO 15189 2012 4 1 14 and Ms Karen Schnauffer Consultant Embryologist respectively The Andrology Laboratory is supervised by Mrs Stephanie Brooks Andrology Supervisor and staffed by trained Andrologists Mrs Judith Cunningham Mr Paul Mallanaphy and Ms Amanda Hall Andrology Practioners Miss Laurie Wishman Mr Andrew Allan and supported by Mrs Cheryl Thomas Medical Laboratory Assistant and Miss Jennifer Edge Scientific Administrative Assistant We
5. gladly be provided on request see Provision of Clinical Advice below 11 INTERPRETIVE COMMENTS amp TERMINOLOGY Term Definition Aspermia No sample produced on ejaculation Azoospermia No sperm present in ejaculate Cryptozoospermia No sperm observed on initial examination but very low numbers observed following centrifugation concentration and examination of entire ejaculate Oligozoospermia 15 million sperm per ml of ejaculate Asthenozoospermia 3296 grade A motility or 4096 grade A grade B motility Teratozoospermia lt 4 normal forms Haemospermia Presence of blood in the ejaculate Incomplete sample collection Patient has failed to collect entire ejaculate In addition other self explanatory interpretative comments may be added Author SB Owner KS Page 7 of 15 Uncontrolled when photocopied Do not use after review date The Hewitt Fertility E Document Code QMS AND UM 4 Document Title Andrology Diagnostic User Manual Livepool Womens Hospital Version No 3 Date of issue 16 07 2015 Date of review 16 07 2016 Hewitt Fertility Centre Owner K Schnauffer Author S Brooks 12 REPORTING OF RESULTS ISO 15189 2012 5 8 A Semen Analysis Report Form is generated by the Hewitt Centre IDEAS database and returned by post to the referring clinician There are normal reference ranges stated on the bottom of this report VERBAL RESULTS WILL NOT BE GIVEN
6. IONS FOR PRODUCTION OF SEMEN SAMPLES eene 5 7 INSTRUCTIONS FOR TRANSPORTATION OF SEMEN 6 S ROUTINE TESTS PROVIDED icc a sanae ex EHE cece een 6 10 EXAMINATION OF POST VASECTOMY SAMPLES 7 11 INTERPRETIVE COMMENTS amp TERMINOLOGY 7 12 REPORTING OF RESULTS ecco ees eect estas nce peacoat 8 13 TURNAROUND TIME Me 8 14 PROVISION OF CLINICAL ADVICE COMPLAINTS e eeeeeeeeeeeeeee nennen nnne nennen 8 15 MEASUREMENT OF UNCERTAINTY nennt nina nnns sene nnnn nnn 8 16 PROCEDURE FLOW DIAGRAWM WITH APPROXIMATE 9 17 REQUEST FORM YOU TO FAX TO US TO REQUEST A SEMEN ANALYSIS 11 18 PATIENT LETTER WE SEND TO PATIENT WITH APPOINTMENT 12 19 SEMEN ANALYSIS FORM WE SEND TO PATIENT WITH APPOINTMENT 13 20 PATIENT INSTRUCTIONS WE SEND TO PATIENT WITH 14 21 OFF SITE PRODUCTION FORM WE SEND TO PATIENT WITH APPOINTMENT 15 16 Author SB Owner KS Page 2 of 15 Uncontrolled when photocopied Do not use after review date
7. The Hewitt Fertility Centre Document Code QMS AND UM 4 Document Title Andrology Diagnostic User Manual Livepool Womens Hospital Version No 3 Date of issue 16 07 2015 Date of review 16 07 2016 Hewitt Fertility Centre Owner K Schnauffer Author S Brooks Liverpool Women s Hospital mz xs sf n DIAGNOSTIC ANDROLOGY SERVICES USER MANUAL Author SB Owner KS Page 1 of 15 Uncontrolled when photocopied Do not use after review date The Hewitt Fertility E Document Code QMS AND UM 4 Document Title Andrology Diagnostic User Manual Livepool Womens Hospital Version No 3 Date of issue 16 07 2015 Date of review 16 07 2016 Hewitt Fertility Centre Owner K Schnauffer Author S Brooks CONTENTS 1 eT 3 2 CONTACT DETAILS c 3 lt OG ups 4 lm n H 4 5 HOW TO REQUEST A SEMEN ANALYSIS iri e thiet uu ran puni einen 4 5 1Referrals from clinics at the Hewitt Fertility Centre Liverpool Women s Hospital 4 5 2 Referrals from GOPD Liverpool Women s 4 5 3 Referrals from outside Liverpool Women s 4 6 INSTRUCT
8. aching and or quality assurance purposes Signature of patient Date f some of the sample was lost during collection please inform a member of the laboratory staff Author SB Owner KS Page 14 of 15 Uncontrolled when photocopied Do not use after review date The Hewitt Fertility E Document Code QMS AND UM 4 Document Title Andrology Diagnostic User Manual Livepool Womens Hospital Version No 3 Date of issue 16 07 2015 Date of review 16 07 2016 Hewitt Fertility Centre Owner K Schnauffer Author S Brooks Section 3 Please complete this section if you are delivering the sample on behalf of your partner Your name Date of birth Your partner s name Date of birth Your partners address What time did your partner produce the sample How many days is it since your partner last ejaculated Did your partner spill any of the sample during collection Yes No Has your partner been ill during last 3 months please describe e g flu Does your partner have or have they ever been told that they have HIV Hepatits B or Hepatitis C Yes No Please confirm the following with regard to the semen sample that you have handed to staff at the Hewitt Fertility centre today V The sample was produced by my partner named above vi The sample has not been tampered with since its production vii That the sample was produced at the time specified above Signature of person delivering sample Date
9. are under the supervision in regards to Quality management by Mrs Sharon Fensome Rimmer who directs the service with regards to maintenance of our Quality management system ISO 15189 2012 4 12 7 4 2 This in conjunction with the team above includes meeting the needs of our users ISO 15189 2012 4 1 2 2 4 4 4 14 3 Service level agreements amp third party agreements ISO 15189 2012 4 4 complaints ISO 15189 2012 4 8 assessment of user feedback ISO 15189 2012 4 14 3 review input ISO 15189 2012 4 15 training of staff and competency assessment ISO 15189 2012 5 1 5 5 1 6 maintenance of facilities ISO 15189 2012 5 2 Equipment maintenance ISO 15189 2012 5 3 reagents and consumables ISO 15189 2012 5 3 2 pre examination processes ISO 15189 2012 5 4 examination processes ISO 15189 2012 5 5 ensuring quality of examination of results ISO 15189 2012 5 6 post examination processes ISO 15189 2012 5 7 reporting of results ISO 15189 2012 5 8 This list is not exhaustive and may include additional items Author SB Owner KS Page 3 of 15 Uncontrolled when photocopied Do not use after review date The Hewitt Fertility E Document Code QMS AND UM 4 Document Title Andrology Diagnostic User Manual Livepool Womens Hospital Version No 3 Date of issue 16 07 2015 Date of review 16 07 2016 Hewitt Fertility Centre Owner K Schnauffer Author S Brooks 3 LOCATION ISO 15189 2012 5 4 2 A The Andrology Labora
10. ctions for the production of semen samples Your appointment is at the Andrology Laboratory on the 2 floor of Liverpool Womens Hospital at the following date and time Date Time Please read the following instructions carefully before producing your semen sample Do not ejaculate for 2 7 days before your appointment e Produce your sample by masturbating into the pot provided e Samples can be produced at home or at the facilities available in the Andrology Laboratory If producing at home the sample must be delivered to the laboratory within one hour and at the date and time given above e Please complete the Record of Sperm Production Form e Results will be given by the referring clinician at your follow up appointment e Do not produce your sample using a condom lubricant the withdrawal method or by any other means other than masturbation e Do not expose to extremes of temperature e f you are unable to ejaculate by masturbation then special condoms designed specifically for the collection of semen samples are available please ask If you do not attend your appointment there may be a 6 8 week wait for a further appointment which may delay your attendance at clinic If you are unsure about any of the above points or are unable to attend this appointment then please contact the Andrology laboratory on 0151 702 4214 Author SB Owner KS Page 13 of 15 Uncontrolled when photocopied Do not use af
11. labelled Record of Semen Production form Appendix 5 v Patient Information Leaflet Appendix 6 When the patient makes contact with the Andrology Laboratory a convenient appointment should be made NB Non routine appointments must be arranged by contacting the Andrology Laboratory 6 INSTRUCTIONS FOR PRODUCTION OF SEMEN SAMPLES ISO 15189 2012 5 4 4 2 Instructions for the production of semen samples are detailed in leaflet entitled Instructions for the production of semen samples see Appendix 2 The date of the appointment should also be entered on this form Patients should be advised to follow the instructions in this leaflet in order to optimise the semen sample that they produce Patients should be provided with a suitable sample collection vessel and plastic transportation bag Patients should be advised to only use the collection vessel provided The following instructions are contained within this leaflet The patient should i notejaculate for between 2 and 7 days prior to their appointment ii only use the pot provided to collect their sample iii clearly label the pot with their name date and time of sample production and the number of days since they last ejaculated iv empty their bladder before producing the semen sample v produce the sample by masturbation and not by withdrawing after intercourse vi not use a condom to collect the sample as condoms can adversely affect sperm vii attempt to c
12. me of your appointment Please contact us on 0151 702 4214 to confirm this appointment or rearrange if not convenient If you fail to confirm this appointment you risk losing your appointment slot If telephoning us to confirm your appointment please feel free to leave a message on the answer machine We may contact you by telephone if you do not want us to do that please inform us of that when you call Please note that all appointments are Monday to Friday 8 30am 2pm Please also find enclosed some instructions It is important that you read these instructions and complete the paperwork Your results will be available from your doctor within 14 days or from your Consultant at your next clinic appointment With kindest regards Yours sincerely Dr Stephen Troup Scientific Director Author SB Owner KS Page 11 of 15 Uncontrolled when photocopied Do not use after review date Document Code QMS AND UM 4 The Hewitt Fertility E Document Title Andrology Diagnostic User Manual Livepool Womens Hospital Version No 3 Date of issue 16 07 2015 Hewitt Fertility Centre Owner K Schnauffer Please circle appropriate clinic HFC OSI GOPD ACWH Sample pot Lot No Time of sample production Abstinence period Date of review 16 07 2016 Author S Brooks Lab code 55 DOB HoSspital DOB H
13. nal parameters SEMINAL PARAMETER COMMENTS Liquefaction A qualitative assessment of how liquefied the ejaculate has become Measured at least 30 minutes post ejaculation pH The pH of the ejaculate Measured at least 30 minutes post ejaculation Appearance A qualitative assessment of the visual appearance of the ejaculate Eg Normal opaque etc Presence of round cells A quantitative assessment of the number of non sperm cells in the ejaculate NB no differentiation is made between non sperm round cells and leucocytes Reported as millions round cells per ml of ejaculate Presence of acellular debris A qualitative assessment of the amount of acelluar debris present in the ejaculate Reported as 0 or Ejaculate volume The volume of the ejaculate measured in millilitres ml Sperm concentration Millions sperm per ml of ejaculate millions ml Sperm morphology Percentage of sperm with normal morphology Sperm motility The motility of at least 200 sperm is assessed at 37 C and expressed as the percentage showing progressive non progressive or immotile Author SB Owner KS Page 6 of 15 Uncontrolled when photocopied Do not use after review date The Hewitt Fertility E Document Code QMS AND UM 4 Document Title Andrology Diagnostic User Manual Livepool Womens Hospital Version No 3 Date of issue 16 07 2015 Date of review 16 07 2016 Hewitt Fertility Centre
14. oSpital no GP Vas Referring clinician NHS PP Analysis interval Viscosity Viscous Non viscous Round Cells 0 3 Weight Weight before 0 3 Total sperm number 10 ml Performed M ejaculate Morphology Performed by Motility at C Performed by Grade A 96 progressive Grade B progressive Grade C non progressive Grade D 96 non motile Agglutination 2 3 Vitality Performed by 4 Average speed Comments Analyst Date Analysed IDEAS 2 person verified Returned Reference ranges WHO 2010 Volume 1 5 mls or more pH 7 2 or more Concentration 15 million sperm per ml or more Total sperm number 39 Million sperm per ejaculate Total motility A B amp C 40 38 42 Progressive motility A amp B 32 31 34 Sperm Morphology 4 or more Vitality 58 55 63 only measured when 90 non motile Author SB Owner KS Page 12 of 15 Uncontrolled when photocopied Do not use after review date The Hewitt Fertility E Document Code QMS AND UM 4 Document Title Andrology Diagnostic User Manual Livepool Womens Hospital Version No 3 Date of issue 16 07 2015 Date of review 16 07 2016 Hewitt Fertility Centre Owner K Schnauffer Author S Brooks Instru
15. ollect ALL of the sample into the pot and advise a member of the Andrology staff if any of the sample is not collected viii If the patient is unable to produce a semen sample by masturbation then special condoms Male Factor Pack are available by prior arrangement with the Andrology Laboratory Author SB Owner KS Page 5 of 15 Uncontrolled when photocopied Do not use after review date The Hewitt Fertility E Document Code QMS AND UM 4 Document Title Andrology Diagnostic User Manual Livepool Womens Hospital Version No 3 Date of issue 16 07 2015 Date of review 16 07 2016 Hewitt Fertility Centre Owner K Schnauffer Author S Brooks 7 INSTRUCTIONS FOR TRANSPORTATION OF SEMEN SAMPLES ISO 15189 2012 5 4 2 H If the patient is producing the sample off site he should be instructed to not expose the sample to extremes of temperature by carrying it in an inside pocket if possible The patient should be instructed to deliver the sample to the Andrology Laboratory WITHIN ONE HOUR of production 8 ROUTINE TESTS PROVIDED ISO 15189 2012 5 4 2 D The Andrology Laboratory provides a range of diagnostic andrology tests and follows recommendations made by the World Health Organisation WHO 2010 Examination and processing of human semen 2010 the British Andrology Society Association of Biomedical Andrologists and the Association of Clinical Embryologists A routine semen analysis will assess the following semi
16. opriate boxes GOPD Hewitt Centre GPL Aintree Ormskirk This referral is NHS PP Date of appointment if known Reason for referral Fertility L_ Sperm Freeze please tick Vasectomy Date performed Date performed Other Vasectomy reversal Is this patient High risk i e Virus positive 1 L Yes please give details Additional information i e History of violence aggression PLEASE FILL IN ALL DETAILS CORRECTLY AND LEGIBLY AND YOUR PATIENT WILL BE CONTACTED TO ARRANGE THEIR APPOINTMENT INCOMPLETE OR ILLEGIBLE FORMS WILL NOT BE PROCESSED Please post or fax this request form to Andrology Laboratory Hewitt Fertility Centre Liverpool Women s Hospital Crown Street Liverpool L8 7SS Tel No 0151 702 4214 Fax No 0151 702 4152 Author SB Owner KS Page 10 of 15 Uncontrolled when photocopied Do not use after review date The Hewitt Fertility E Document Code QMS AND UM 4 Document Title Andrology Diagnostic User Manual Livepool Womens Hospital Version No 3 Date of issue 16 07 2015 Date of review 16 07 2016 Hewitt Fertility Centre Owner K Schnauffer Author S Brooks Dear Sir Re Semen Analysis Your doctor has asked us to contact you in order to arrange an appointment to attend for a semen analysis test Please find enclosed a pack containing your sample pot s and paperwork On one of these forms it indicates the date and ti
17. ormation leaflet 5 2 Referrals from GOPD Liverpool Women s Hospital Using the green folder next available slot is located and the patients ID label and partners are firmly fixed onto the appropriate location The patients Consultant is recorded also This date and time are agreed with the patient and written in the appropriate slot on the patient information leaflet This is then taken periodically by Andrology staff to update IDEAS and Meditech 5 3 Referrals from outside Liverpool Women s Hospital Clinicians wishing to arrange an appointment for a semen analysis should complete a Semen Analysis Request Form See Appendix 1 It is essential that this form is completed in full and is legible The Semen Analysis Request Form should be faxed to 0151 702 4152 Author SB Owner KS Page 4 of 15 Uncontrolled when photocopied Do not use after review date The Hewitt Fertility E Document Code QMS AND UM 4 Document Title Andrology Diagnostic User Manual Livepool Womens Hospital Version No 3 Date of issue 16 07 2015 Date of review 16 07 2016 Hewitt Fertility Centre Owner K Schnauffer Author S Brooks On receipt of this form the Andrology Laboratory will arrange an appointment by sending the patient a pack containing the following i covering letter see Appendix 2 ii labelled semen collection pot s iii labelled Semen Analysis form Appendix 3 amp 4 including a date and time of their appointment iv
18. ter review date The Hewitt Fertility E Document Code QMS AND UM 4 Document Title Andrology Diagnostic User Manual Livepool Womens Hospital Version No 3 Date of issue 16 07 2015 Date of review 16 07 2016 Hewitt Fertility Centre Owner K Schnauffer Author S Brooks SECTION I TO BE COMPLETED BY MALE OR FEMALE PARTNER confirm that the sample container is correctly labelled with my my partners correct details including name D O B and address if applicable Signature of patient partner confirming details on sample pot Date Section 2 Please complete this section if you are the man who has produced the sample Your name Date of birth Partner s name Date of birth Your address Where was your sample produced At home At the Hewitt Fertility Centre Please delete as appropriate What time was your sample produced How many days is it since you last ejaculated Was any of the sample spilled during collection Yes No Have you been ill during last 3 months eg Flu Do you have or have you ever been told that you have HIV Hepatits B or Hepatitis C Yes No confirm the following with regard to the semen sample that have handed to staff at the Hewitt Fertility centre today That the sample was produced by me That the sample has not been tampered with since its production That the sample was produced at the time specified above am happy for any surplus specimen to be used for te
19. that you consider when interpreting the results that we provide Author SB Owner KS Page 8 of 15 Uncontrolled when photocopied Do not use after review date The Hewitt Fertility Centre Document Code QMS AND UM 4 Document Title Andrology Diagnostic User Manual Livepool Womens Hospital Version No 3 Date of issue 16 07 2015 Date of review 16 07 2016 Hewitt Fertility Centre Owner K Schnauffer Author S Brooks 16 PROCEDURE FLOW DIAGRAM WITH APPROXIMATE TIMESCALES Patient attends i appointment with R Appointment pp _ Sample processed Report back to referrer Referral IE instruction sample without sample as and report pot sent out appropriate produced lt 2 weeks gt 2 weeks gt lt 2 weeks gt Author SB Owner KS Page 9 of 15 Uncontrolled when photocopied Do not use after review date Document Code QMS AND UM 4 The Hewitt Fertility E Document Title Andrology Diagnostic User Manual Livepool Womens Hospital Version No 3 Date of issue 16 07 2015 Hewitt Fertility Centre Owner K Schnauffer Date of review 16 07 2016 Author S Brooks Attach Patient Label Male name Date of Birth Mobile Tel no Address NHS No Attach Patient Label Female name Date of Birth Mobile Tel No Address NHS No Details of referring Clinician Clinicians Name Practice address Please use Practice Stamp Please tick appr
20. tory is situated on the 2 floor of the Liverpool Womens Hospital From the main entrance of the hospital proceed to the left and using lifts 3 amp 4 go to the 2 floor On exiting the lift turn to the right and the Andrology Laboratory entrance is located on the left 4 OPENING TIMES ISO 15189 2012 5 4 2 C The Andrology Laboratory at Liverpool Womens hospital is open 0830 1630 Monday to Friday although usually closed on Bank Holidays There is a telephone service and answer machine in operation when the laboratory is closed on 0151 702 4214 This service can be used regarding appointments which need to be cancelled or changed There is no out of hours service unless exceptional circumstances prevail 5 HOW TO REQUEST A SEMEN ANALYSIS ISO 15189 2012 5 4 3 5 1Referrals from clinics at the Hewitt Fertility Centre Liverpool Women s Hospital Appointments can be made for patients already on the IDEAS system immediately by any staff member on the Hewitt centre who has been trained to give patients the correct labelled sample pots and paperwork Using the IDEAS system locate the next available on the Seminology diary Green list then insert the patients details into the available slot In the details section it must be indicated where the results are to go back to the patients Consultant and if the patient is NHS or self funding PP This date and time are agreed with the patient and written in the appropriate slot on the patient inf
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