DIAGNOSTIC ANDROLOGY SERVICES USER MANUAL
Contents
1. 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 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 16 of 16 Uncontrolled when photocopied Do not use after review date2. 16 07 2015 Date of review 16 07 2016 Hewitt Fertility Centre Owner K Schnauffer Author S Brooks A routine semen analysis will assess the following seminal 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 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 volume The volume of the ejaculate measured in millilitres ml Sperm concentration Millions sperm per ml of ejaculate millions ml Sperm morphology Pecentage of sperm with normal morphology 96 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 Presence of agglutination A qualitative assessment of the numbers of sperm sticking to each other Re
3. 4 5 HOW TO REQUEST A SEMEN 5 4 5 1 Referrals from within the Knutsford Facility 4 6 INSTRUCTIONS FOR PRODUCTION OF SEMEN SAMPLES 5 7 INSTRUCTIONS FOR TRANSPORTATION OF SEMEN SAMPLES 6 8 ROUTINE TESTS Ua a cin E n 6 10 EXAMINATION OF POST VASECTOMY SAMPLES 7 11 INTERPRETIVE COMMENTS amp 8 12 REPORTING OF HESUETS 8 13 TURNAROUND TIME 9 14 PROVISION OF CLINICAL ADVICE COMPLAINTS 9 15 MEASUREMENT OF UNCERTAINTY nnn n nnn n nnn nn nnns 9 16 PROCEDURE FLOW DIAGRAM WITH APPROXIMATE TIMESCALES 10 Page 2 of 16 Owner K Schnauffer Uncontrolled when photocopied Author s Brooks Do not use after review date The Hewitt Fertility 2 Document Code QMS AND UM 5 Document Title Andrology Laboratory User Manual
4. 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 teaching and or quality assurance purposes Signature of patient Date If some of the sample was lost during collection please inform a member of the laboratory staff Author SB Owner KS Page 15 of 16 Uncontrolled when photocopied Do not use after review date The Hewitt Fertility 2 Document Code QMS AND UM 5 Document Title Andrology Laboratory User Manual Hewitt Fertility Centre Knutsford Version No 2 Date of issue 12 03 2014 Date of review 12 03 2015 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
5. Hewitt Fertility Centre Knutsford 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 at the Hewitt Fertility Centre 2 Knutsford This department is manned part time and is therefore under the direction and facilitated administratively by the Andrology laboratory Hewitt Fertility Centre at the Liverpool Women s Hospital 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 4 The Pavillions Knutsford Business Park Mobberley Road Knutsford WA16 8ZR OR Andrology Laboratory Hewitt Fertility Centre Liverpool Women s Hospital Crown Street Liverpool L8 7SS Tel 0151 702 4214 Fax 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 Andrology Practioners Miss Laurie Wishman Mr Andrew Allan and supported by Biomedical Andrologists Mrs Judith Page 3 of 16 Ow
6. MEN 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 Page 5 of 16 Owner K Schnauffer Uncontrolled when photocopied Author s Brooks Do not use after review date The Hewitt Fertility 2 Document Code QMS AND UM 5 Document Title Andrology Laboratory User Manual Hewitt Fertility Centre Knutsford Version No 3 Date of issue 16 07 2015 Date of review 16 07 2016 Hewitt Fertility Centre Owner K Schnauffer Author S Brooks 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 con
7. 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 time of your appointment Please contact us on 01565 635000 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 Tuesday 8 30 am 12 00 noon Alternative arrangements can be arranged upon request 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 Please note that your appointment is for the Andrology Laboratory 4 The Pavillions Knutsford Business Park Mobberley Road Knutsford WA16 8ZR With kindest regards Yours sincerely Dr Stephen Troup Scientific Director Page 12 of 16 Owner K Schnauffer Uncontrolled when photocopied Author s Brooks Do not use after review date The Hewitt Fertility Centre Document Code QMS AND UM 5 Document Title Andrology Laboratory User Manual Hewitt Fertility Centre Knutsford Vers
8. The Hewitt Fertility Centre Date of review 16 07 2016 Author S Brooks Page 1 of 16 Hewitt Centre Knutsford huy HET AH HHH In 1H AM H 2 Jd i LI UT USER MANUAL Document Code QMS AND UM 5 Document Title Andrology Laboratory User Manual Hewitt Fertility Centre Knutsford Version No 3 Date of issue 16 07 2015 Hewitt Fertility Centre Owner K Schnauffer DIAGNOSTIC ANDROLOGY SERVICES Owner K Schnauffer Author s Brooks The Hewitt Fertility 2 Document Code QMS AND UM 5 Document Title Andrology Laboratory User Manual Hewitt Fertility Centre Knutsford 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 CONTENTS a ss p 2 Ms MINTO TON irc 3 2 CONTACT IDE UAE 5 3 3 LOCATION 4 4 OPENING TIMES meer
9. Vitality 58 96 55 63 only measured when 90 non motile Author SB Owner KS Page 13 of 16 Uncontrolled when photocopied Do not use after review date The Hewitt Fertility 2 Document Code QMS AND UM 5 Document Title Andrology Laboratory User Manual Hewitt Fertility Centre Knutsford Version No 2 Date of issue 12 03 2014 Date of review 12 03 2015 Hewitt Fertility Centre Owner K Schnauffer Author S Brooks Instructions for the production of semen samples Your appointment is at the Andrology Laboratory Date Time at Hewitt Fertility Centre Knutsford at the following Date and time Please read the following instructions carefully before producing your semen sample e 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 Do not expose to extremes of temperature e f you are unable to ejaculate by masturbation then special condoms design
10. dom to collect the sample as condoms can adversely affect sperm vii attempt to collect 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 a Factor are available by prior arrangement with the Andrology Laboratory 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 Laboratory manual for the examination and processing of human semen 5th Edition 2010 the British Andrology Society Association of Biomedical Andrologists and the Association of Clinical Embryologists Page 6 of 16 Owner K Schnauffer Uncontrolled when photocopied Author s Brooks Do not use after review date The Hewitt Fertility 2 Document Code QMS AND UM 5 Document Title Andrology Laboratory User Manual Hewitt Fertility Centre Knutsford Version No 3 Date of issue
11. ed 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 01565 635000 Author SB Owner KS Page 14 of 16 Uncontrolled when photocopied Do not use after review date The Hewitt Fertility 2 Document Code QMS AND UM 5 Document Title Andrology Laboratory User Manual Hewitt Fertility Centre Knutsford Version No 2 Date of issue 12 03 2014 Date of review 12 03 2015 Hewitt Fertility Centre Owner K Schnauffer Author S Brooks SECTION 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 If at home what time was your sample produced How many days is it since you last ejaculated Was any of the sample spilled
12. ion No 2 Date of issue 12 03 2014 Date of review 12 03 2015 Hewitt Fertility Centre Owner K Schnauffer Author S Brooks Date of Lab code NO iur rrr de en Rn Male DOB ete Hospital Femaleiame uci DOB ne Hospital no Please circle appropriate clinic Knutsford GP Vas Referring clinician NHS PP Sample pot Lot No Time of sample production Analysis interval Abstinence period Viscosity Viscous Non viscous Round Cells x 108 ml Motility at C Performed by 0 3 Weight Weight before 0 3 x 10 ml Performed by Grade A progressive Total sperm number M ejaculate Grade B progressive Morphology Performed by Grade C non progressive Grade D non motile Agglutination 2 3 Average speed M sec Vitality Performed by Comments Analyst Analysed IDEAS 9nd 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 4296 Progressive motility A amp B 32 96 31 3496 Sperm Morphology 4 or more
13. ity Centre Knutsford Version No 3 Date of issue 16 07 2015 Date of review 16 07 2016 Hewitt Fertility Centre Owner K Schnauffer Author S Brooks VERBAL RESULTS WILL NOT BE GIVEN 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 Mr Richard Russell 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 7S8 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 whe
14. l Attach Patient Label Male name Female name Date of Birth Date of Birth Mobile Tel no Mobile Tel No Address Address NHS No NHS No Details of referring Clinician Please use Practice Stamp Clinicians Name Practice address Please tick appropriate boxes Hewitt Centre Other This referral 15 NHS PP Date of appointment if known Reason for referral Fertility C Sperm Freeze please tick Vasectomy Vasectomy reversal Date performed Date performed Other Is this patient High risk i e Virus positive C Yes please give details L No Additional information i e History of violence aggression Please post or fax this request form to PLEASE FILL IN ALL DETAILS CORRECTLY Andrology Laboratory AND LEGIBLY AND YOUR PATIENT WILL BE 4 The Pavillions CONTACTED TO ARRANGE THEIR Knutsford Business Park APPOINTMENT Mobberley Road INCOMPLETE OR ILLEGIBLE FORMS Knutsford WILL NOT BE PROCESSED WA16 8ZR Tel No 01565 635000 Fax No 01565 635003 Page 11 of 16 Owner K Schnauffer Uncontrolled when photocopied Author s Brooks Do not use after review date The Hewitt Fertility 2 Document Code QMS AND UM 5 Document Title Andrology Laboratory User Manual Hewitt Fertility Centre Knutsford 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
15. n 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 Page 9 of 16 Owner K Schnauffer Uncontrolled when photocopied Author s Brooks Do not use after review date The Hewitt Fertility 2 Document Code QMS AND UM 5 Document Title Andrology Laboratory User Manual Hewitt Fertility Centre Knutsford Version No 3 Date of issue 16 07 2015 Date of review 16 07 2016 Hewitt Fertility Centre Owner K Schnauffer Author S Brooks the back with bullet points that you are asked that you consider when interpreting the results that we provide 16 Procedure flow diagram with approximate timescales Patient attends Appointment appointment with Sample processed Referral instruction sample without sample as appropriate produced 2 weeks gt 2 weeks gt 2 weeks gt Page 10 of 16 Owner K Schnauffer Uncontrolled when photocopied Author s Brooks Do not use after review date Report back to referrer The Hewitt Fertility 2 Document Code QMS AND UM 5 Document Title Andrology Laboratory User Manual Hewitt Fertility Centre Knutsford Version No 3 Date of issue 16 07 2015 Date of review 16 07 2016 Hewitt Fertility Centre Owner K Schnauffer Author S Brooks Attach Patient Labe
16. ner K Schnauffer Uncontrolled when photocopied Author s Brooks Do not use after review date The Hewitt Fertility 2 Document Code QMS AND UM 5 Document Title Andrology Laboratory User Manual Hewitt Fertility Centre Knutsford Version No 3 Date of issue 16 07 2015 Date of review 16 07 2016 Hewitt Fertility Centre Owner K Schnauffer Author S Brooks Cunningham Mr Paul Mallanaphy and Ms Amanda Hall supported by Mrs Cheryl Thomas Medical Laboratory Assistant and Miss Jennifer Edge Scientific Administrative assistant 3 LOCATION The Andrology Laboratory is situated on the ground floor of the Hewitt Fertility Centre Knutsford Patients are to announce themselves at the reception of the department where they will be directed by staff from there 4 OPENING TIMES ISO 15189 2012 5 4 2 A The Andrology Laboratory at Knutsford is open 08 30 12 30 Tuesdays At the Liverpool Women s Hospital there is a telephone service and answer machine in operation when the laboratory is closed on 01565 635000 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 1 Referrals from within the Knutsford Facility Semen analysis should be booked in using the Knutsford Andrology appointments diary on IDEAS and must include patients consultan
17. ported as 1 2 3 or 4 1 being minimal and 4 being the majority Sperm viability Percentage of viable sperm only measured if sperm motility 9096 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 Owner K Schnauffer Author s Brooks Page 7 of 16 Uncontrolled when photocopied Do not use after review date The Hewitt Fertility 2 Document Code QMS AND UM 5 Document Title Andrology Laboratory User Manual Hewitt Fertility Centre Knutsford Version No 3 Date of issue 16 07 2015 Date of review 16 07 2016 Hewitt Fertility Centre Owner K Schnauffer Author S Brooks 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 Seminology Laboratory will report any observations including the presence of very low numbers of immotile sperm If greater than 50 non motile sperm are seen on 10ul a concentration will be performed to a
18. ssist clinicians in 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 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 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 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 Page 8 of 16 Owner K Schnauffer Uncontrolled when photocopied Author s Brooks Do not use after review date centrifugation concentration and examination of The Hewitt Fertility 2 Document Code QMS AND UM 5 Document Title Andrology Laboratory User Manual Hewitt Fertil
19. t self funding or NHS and where to send the result back to 5 2 Referrals from outside Hewitt Fertility Centre 2 Knutsford 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 01565 635000 Page 4 of 16 Owner K Schnauffer Uncontrolled when photocopied Author s Brooks Do not use after review date The Hewitt Fertility 2 Document Code QMS AND UM 5 Document Title Andrology Laboratory User Manual Hewitt Fertility Centre Knutsford 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 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 SE
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