Countess of Chester Seminology User Manual
Contents
1. 1 INTRODUCTION This manual describes the policies procedures and repertoire of the Seminology Laboratory Countess of Chester Fertility and Assisted of Conception Unit This department is manned part time and is therefore under the direction and facilitated administratively by the 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 Seminology Laboratory is Seminology Laboratory Countess of Chester Fertility and Assisted Conception Unit Countess of Chester Hospital NHS Foundation Trust Countess of Chester Health Park Liverpool Road Chester CH2 1UL The Seminology 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 Seminology Laboratory at Unit is staffed by Embryology Trainees Mrs Grace Haresnape and Miss Lauren Wallace and Miss Kyriaki Andreou this is with the support of Clinical Scientists Miss Hannah Marsden Miss Rebecca Lunt Mrs Natalie Scott and Mrs Lorraine Smullen who are all based at the Hewitt Fertility Centre We are under the supervision in regards to Quality management by Mrs Sharon Fensome Rimmer who directs the service with regards to maintenance of2. 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 Uncontrolled when photocopied Do not use after review date Page 9 of 12 The Hewitt Fertility cae Document Code QMS AND UM 2 Document Title Countess of Chester Seminology Laboratory User Manual Version No 3 Date of issue 16 07 2015 Date of review 16 07 2016 Hewitt Fertility Centre Owner K Schnauffer Author S Brooks Instructions for the production of semen samples Your appointment is at Date Time the Andrology Laboratory at the Assisted conception Unit Countess of Chester Hosptial 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 e
3. Document Code QMS AND UM 2 Document Title Countess of Chester Seminology Laboratory User Manual 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 following instructions are contained within this leaflet The patient should i not ejaculate 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 collect ALL of the sample into the pot and advise a member of the Seminology 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 Male Factor Pack are available by prior arrangement with the Seminology 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
4. 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 01244 366401 Author SB Owner KS Page 10 of 12 Uncontrolled when photocopied Do not use after review date The Hewitt Fertility cae Document Code QMS AND UM 2 Document Title Countess of Chester Seminology Laboratory User Manual 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 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 Assisted Conception Unit Please delete as appropriate If at home wha
5. 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 Author SB Owner KS Page 3 of 12 Uncontrolled when photocopied Do not use after review date The Hewitt Fertility cae Document Code QMS AND UM 2 Document Title Countess of Chester Seminology Laboratory User Manual Version No 3 Date of issue 16 07 2015 Date of review 16 07 2016 Hewitt Fertility Centre Owner K Schnauffer Author S Brooks 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 3 LOCATION ISO 15189 2012 5 4 2 A The Seminology Laboratory is situated on the 1 floor of Countess of Chester Hospital From the Ante natal Clinic entrance take the
6. the Seminology Laboratory WITHIN ONE HOUR of production 8 ROUTINE TESTS PROVIDED ISO 15189 2012 5 4 2 D The Seminology Laboratory provides a range of diagnostic seminology 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 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 Author SB Owner KS Page 5 of 12 Uncontrolled when photocopied Do not use after review date The Hewitt Fertility cae Document Code QMS AND UM 2 Document Title Countess of Chester Seminology Laboratory User Manual Version No 3 Date of issue 16 07 2015 Date of review 16 07 2016 Hewitt Fertility Centre Owner K Schnauffer Author S Brooks pH The pH of the ejaculate Measured at least 30 minutes post ejaculation Appearance A qualitative assessment of the visual appearance of the ejaculate E g 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 ce
7. The Hewitt Fertility Centre Document Code QMS AND UM 2 Document Title Countess of Chester Seminology Laboratory User Manual Version No 3 Date of issue 16 07 2015 Date of review 16 07 2016 Hewitt Fertility Centre Owner K Schnauffer Author S Brooks Countess of Chester Fertility Centre Author SB Owner KS Page 1 of 12 The Hewitt Fertility cae Document Code QMS AND UM 2 Document Title Countess of Chester Seminology Laboratory User Manual Version No 3 Date of issue 16 07 2015 Date of review 16 07 2016 Hewitt Fertility Centre Owner K Schnauffer Author S Brooks DIAGNOSTIC SEMINOLOGY SERVICES USER MANUAL CONTENTS GONTENTS scrieri eine a a E R EE EE a EEEa eiii aA 2 2 CONTAC I DETAILS ciiis 3 9 LOCA MON ctrectan sede a estar oeeepiaeiee eneianeenaeae ine ainsiagitie nel 4 4 OPENING TIMES ws ssieccareiiiatarsiaiciaraihiesansnicanaistonataiaabreaseaatssomcanisouatiamanineaaniawaaniae 4 5 HOW TO REQUEST A SEMEN ANALYSIS cece eeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeees 4 6 INSTRUCTIONS FOR PRODUCTION OF SEMEN SAMPLES ceeeeeeeeeeeeeeeeeeeeeees 4 7 INSTRUCTIONS FOR TRANSPORTATION OF SEMEN SAMPLES onnan 5 8 ROUTINE TESTS PROVIDED iacustieneionen aeneae a eaa ae 5 9 ADDITIONAL TESTS PROVIDED ccceeeeeeeeeeeeees Error Bookmark not defined 9 1 MOTILITY INDEX siistsincactssintare
8. f 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 Where greater than 50 non motile sperm have been identified a concentration will be performed to assist the clinician 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 Author SB Owner KS Page 6 of 12 Uncontrolled when photocopied Do not use after review date The Hewitt Fertility cae Document Code QMS AND UM 2 Document Title Countess of Chester Seminology Laboratory User Manual Version No 3 Date of issue 16 07 2015 Date of review 16 07 2016 Hewitt Fertility Centre Owner K Schnauffer Author S Brooks 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 lt 15 million sperm per ml of ejacula
9. lls 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 sperm A qualitative assessment of the numbers of sperm sticking to each other Reported as 1 2 3 or 4 1 being least agglutination 4 majority of soerm stuck together 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 9812 816 Presence of agglutination Sperm viability 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 o
10. onsultant Clinical Andrologist 0151 702 4215 Andrology Laboratory 0151 702 4214 Or by e mail enquiry to stephen troup Iwh nhs uk Complaints should be directed to the Quality Manager or Scientific Director at the Hewitt Fertility Centre Liverpool Women s 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 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 and report Rapant beek t pot sent out appropriate produced referrer 2 weeks gt 2 weeks gt 2 weeks gt Author SB Owner KS Page 8 of 12 Uncontrolled when
11. photocopied Do not use after review date The Hewitt Fertility Centre Document Code QMS AND UM 2 Document Title Countess of Chester Seminology Laboratory User Manual Version No 3 Date of issue 16 07 2015 Date of review 16 07 2016 Hewitt Fertility Centre Owner K Schnauffer Author S Brooks Female name Please circle appropriate clinic Chester HFC GP Sample pot Lot No Time of sample production Abstinence period 0 3 ree DOB ccceeeeeeeee HOSPITAL NO oo cece eeeeeeeeeeeeeees A E DOB ccecesssseeeeeeeeeees HOSPITAL NO onnan ceceeee eee eeeeerenes Vas Clinic NHS PP Analysis interval Viscosity Viscous Non viscous Round Cells x 10 ml Motility at C Performed by Weight Weight before 0 3 Total sperm number x 10 ml Morphology sss Performed by Grade A progressive Performed by Grade B progressive M ejaculate Grade C non progressive Grade D non motile Agglutination 1 2 Vitality Performed by 3 4 Average speed Comments Analyst Analysed IDEAS ona person verified Reference ranges WHO 2010 Returned 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
12. 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 Assisted conception 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 If 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 Author SB Owner KS Page 12 of 12 Uncontrolled when photocopied Do not use after review date
13. stairs or lift to the 1 floor Follow signs to the Fertility and Assisted Conception Unit 4 OPENING TIMES ISO 15189 2012 5 4 2 C The Seminology Laboratory at Chester Fertility Unit is open 0900 1300 Monday to Friday 5 HOW TO REQUEST A SEMEN ANALYSIS ISO 15189 2012 5 4 3 Appointments are made following referral from a GP by and contacting the Fertility Unit Secretary on 01244 336401 Appendix 1 Appointments are also made following a request from the Fertility Clinic at the Chester Fertility and Assisted Conception Unit directly with the Fertility Unit Secretary This telephone number is also used to cancel or change existing appointments There is no out of hours service unless exceptional circumstances prevail 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 3 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 Author SB Owner KS Page 4 of 12 Uncontrolled when photocopied Do not use after review date The Hewitt Fertility cae
14. t 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 Assisted conception unit 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 11 of 12 Uncontrolled when photocopied Do not use after review date The Hewitt Fertility cae Document Code QMS AND UM 2 Document Title Countess of Chester Seminology Laboratory User Manual 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
15. te Asthenozoospermia lt 32 grade A motility or lt 40 grade A grade B motility within 60 mins of production 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 VERBAL RESULTS WILL NOT BE GIVEN OUT UNDER ANY CIRCUMSTANCES The Seminology Laboratory endeavours to return results within 2 weeks of patient attendance 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 Author SB Owner KS Page 7 of 12 Uncontrolled when photocopied Do not use after review date The Hewitt Fertility gt Document Code QMS AND UM 2 Document Title Countess of Chester Seminology Laboratory User Manual Version No 3 Date of issue 16 07 2015 Date of review 16 07 2016 Hewitt Fertility Centre Owner K Schnauffer Author S Brooks Dr Stephen Troup Scientific Director 0151 702 4173 Mr Richard Russell C
16. tsnitssenai ee ariatien Error Bookmark not defined 9 2 SPERM MIGRATION TEST SMT Error Bookmark not defined 10 EXAMINATION OF POST VASECTOMY SAMPLES cccccccccceeeeeeeeeeeeeeeeeeeeeeeeeeeeeeess 6 11 INTERPRETIVE COMMENTS amp TERMINOLOGY cccccccccceeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeess 7 12 REPORTING OF RESULTS vcscntiscehcottenciiecnieseenteiuobbeiedysdeetadnibeeieiwibdnutinbendednidenladsibiacednins 7 13 TURNAROUND TIME v ereccion aaa ra EEEa EEEE aimee 7 14 PROVISION OF CLINICAL ADVICE COMPLAINTS ccccccccccceceeeeeeeeeeeeeeeeeeeeeeeeeeeeeess 7 15 MEASUREMENT OF UNCERTAINTY iscvcscvistsescnsaentacsiataanvntacsenrnencntanmesentacniacatadererntniniars 8 16 PROCEDURE FLOW DIAGRAM WITH APPROXIMATE TIMESCALES 008 8 17 REQUEST FORM YOU TO FAX TO US TO REQUEST A SEMEN ANALYSIS 10 18 SEMEN ANALYSIS FORM WE SEND TO PATIENT WITH APPOINTMENT 11 19 PATIENT INSTRUCTIONS WE SEND TO PATIENT WITH APPOINTMENT 12 20 OFF SITE PRODUCTION FORM WE SEND TO PATIENT WITH APPOINTMENT 13 Author SB Owner KS Page 2 of 12 Uncontrolled when photocopied Do not use after review date The Hewitt Fertility cae Document Code QMS AND UM 2 Document Title Countess of Chester Seminology Laboratory User Manual Version No 3 Date of issue 16 07 2015 Date of review 16 07 2016 Hewitt Fertility Centre Owner K Schnauffer Author S Brooks
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