Laboratory Andrology

Laboratory Andrology
Guidelines for Good Practice

Version 1.0 March 2004
ABA guidelines for good practice 1 edition 3/04
st
Association of Biomedical Andrologists (http://www.aba.uk.net) Guidelines for good practice
Index
INDEX ..............................................................................................................2 INTRODUCTION..............................................................................................3
A 1 2 3 4 5 B C D 1 2 3 E 1 2 3 4 F 1 2 3 G 1 2 H 1 2 3 4 5 Organisation and Quality Management............................................................................................ 4 Total Quality Management (TQM) ....................................................................................... 4 Laboratory Documentation................................................................................................... 4 Regulation in Laboratory Andrology .................................................................................... 6 Record Keeping .................................................................................................................... 6 Management Review............................................................................................................ 7 Personnel ................................................................................................................................................ 9 Premises and Environment ............................................................................................................... 10 Equipment, information systems and reagents .............................................................................. 12 General................................................................................................................................ 12 Semen Analysis .................................................................................................................. 12 Sperm Cryopreservation .................................................................................................... 13 Pre- Examination Processes .............................................................................................................. 15 Information for Service Users ............................................................................................ 15 Request Forms ................................................................................................................... 16 Specimen Collection........................................................................................................... 16 Specimen Reception .......................................................................................................... 17 Examination Processes ....................................................................................................................... 18 Laboratory Processes ........................................................................................................ 18 Management Processes .................................................................................................... 22 Risk Management Procedures .......................................................................................... 23 The post examination phase.............................................................................................................. 26 Reporting Results ............................................................................................................... 26 Clinical Interpretation.......................................................................................................... 27 Evaluation and Quality Assurance .................................................................................................. 28 Audit..................................................................................................................................... 28 Assessment of user satisfaction and complaints ............................................................. 29 Performance Indicators ...................................................................................................... 29 Internal Quality Control....................................................................................................... 29 External Quality Assurance (EQA) Schemes ................................................................... 30
REFERENCES...............................................................................................31 GLOSSARY OF TERMS................................................................................34 APPENDICES ................................................................................................41

1 2 3 4 5 6 Example of a Laboratory Policy ......................................................................................... 41 Subheadings for SOPs....................................................................................................... 42 SOP management .............................................................................................................. 42 Guidelines for the retention of specimens and records of specimens ............................ 43 Management Review Subheadings................................................................................... 44 Examples of vertical audits in andrology........................................................................... 45
Page 2 of 48 March 2004 Version 1.0
Introduction
The following guidelines have been developed by the ABA to be used in andrology laboratories in the British Isles. They are aimed at providing guidance on current best practice for both diagnostic and treatment-associated andrology and should be seen as supplementary to the CPA (Clinical Pathology Accreditation UK) accreditation standards for medical laboratories or the HFEA accreditation standards for licensed fertility centres (HFEA, 2004). All laboratories are obliged to comply with other statutory legislation such as the Health and Safety at Work act (1974), Control of Substances Hazardous to Health (COSHH) regulations (1999) and the Human Fertilisation and Embryology act (1990), where applicable. The overarching accreditation standards for medical laboratories produced by Clinical Pathology Accreditation (CPA) UK Ltd and those for Fertility clinics produced by the Human Fertilisation and Embryology Authority (HFEA) are similarly presented in the following eight sections: A Organisation and quality management system; B Personnel; C Premises and environment; D Equipment, information systems and reagents; E Pre- examination process; F Examination process; G The post examination phase; and H Evaluation and quality assurance. As such the ABA guidelines for good practice are subdivided along the same lines. Guidelines for current best practice have been drawn together from current legislation, from experts in the field of clinical andrology and the ABA as their representative professional body. Evidence for best practice is provided where relevant and where possible, otherwise a consensus opinion of the ABA is provided.
A
1
Organisation and Quality Management
Total Quality Management (TQM)
The implementation of a management system based on setting objectives and implementing policies and procedures, which will achieve those objectives, will undoubtedly lead to dramatic improvements on quality of service delivery. The quality system and its implementation is described in detail in standards for ART (HFEA, 2004), by CPAs standards for the Medical Laboratory and extensively covered by Burnett (2002). As such the purpose of this section is to provide a brief overview and a focus for some of the fundamental quality management issues in andrology, giving examples where possible. Andrology laboratories should aim to build a service with quality as its focus, incorporating resources (facilities, personnel, equipment), document management and control, risk management and the evaluation of service quality as key elements. 1.1 Quality Manual The quality manual is an all-encompassing active document, which is used to describe the entire TQM system, how the different elements of it fit and work together to carry out the laboratory objectives. The document should contain information on: a. Policy. These may be subdivided e.g. laboratory, personnel, quality etc and should describe the intention of the laboratory with regard to ensuring quality. b. Description of the TQM system c. The laboratory structure (personnel and personnel relationships), function, its repertoire and position within the parent organisation. The use of organisational charts is often helpful in demonstrating staffing structure and relationships between the laboratory, its users and associated organisations. d. A description of the documentation and document control system used in the laboratory (see appendix A3). e. Documented evidence which shows how policies and procedures described in d. above comply with the standards laid down by relevant regulatory bodies such as the HFEA, CPA, MHRA and HSE. 2 Laboratory Documentation
The documentation of any organisation is extremely important and the laboratory is no exception. A hierarchical structure to documentation similar to that shown below should exist and be described within the quality manual: Policy Procedures (SOPs) Protocol (or working instructions) Forms (or reports/std letters)
2.1 Policy Policy should simply define the laboratorys intentions or plan of action for the delivery of its service. A typical example of a laboratory policy in andrology is shown in appendix A1. There may be other policies either within the department or parent organisation, which may need to be referred to also (e.g. Trust risk management policy, personnel policy). 2.2 Standard Operating Procedures (SOPs) SOPs are Controlled documents describing methodology for all technical or management activities within and relating to the laboratory. All SOPs should be written to an agreed format and this itself will require an SOP. An SOP for writing SOPs should describe exactly what information is to be included and how all documents including SOPs will be managed. SOPs may be managed by a manual system in a similar fashion to that described in A2 and A3. Centres may prefer to use document management software such as Q-Pulse (www.procadgroup.com) or Lab Passport (www.genialgenetics.com). The following principles relating to SOPs should be adhered to: a. Laboratory activities must be carried out according to written standard operating procedures in line with the centres quality system b. All standard operating procedures must be dated and signed by the author and approved by the senior scientist or head of department. c. Standard operating procedures should include the scope and purpose, the equipment/reagents required, as well as the protocol to be followed. d. Standard operating procedures should be identifiable by version number. e. Standard operating procedures should be reviewed at least annually, and obsolete versions removed from circulation and archived. f. A regular systems audit should be carried out and documented to validate staff compliance with standard operating procedure. An example of SOP sub-headings and content is shown in Appendix A2. 2.3 Protocol Protocol or working instructions are often numbered lists describing how to carry out a particular task. One or more may be incorporated into an SOP. 2.4 Forms (reports) Standard forms or reports are used to record a particular procedure. More than one form may relate to a single procedure and these should be cross-referenced within the SOP. Any standard letters also used could be classed as a form, and should be similarly coded and cross-reference within the SOP.
Regulation in Laboratory Andrology
3.1 The Human Fertilisation and Embryology Authority (HFEA) a. All controlled activities (treatment, storage, donation, research) relating to human sperm (or testicular tissue) should be conducted according to the conditions of any licence granted by the Human Fertilisation and Embryology Authority. b. Activities must not be carried out except under the terms of such a licence. c. Persons must not carry out any clinical procedure, controlled or otherwise, involving sperm (or testicular tissue) without having clear and direct evidence of relevant patient consent. d. All procedures involving the processing, combination or movement of sperm (or testicular tissue) from one culture vessel to another or in or out of cryo storage must be witnessed by an appropriate person in accordance with current guidelines from the HFEA. 3.2 Other Regulation Account must be taken of guidance and regulations issued by all relevant bodies including the Health and Safety Executive (HSE) and the Medicines and Healthcare Products Regulatory Agency (MHRA). 4 Record Keeping
4.1 General Laboratory management shall establish a procedure(s) for controlling records that relate to the identification, collection, indexing, access, filing, storage and disposal all records. Retention of records must be in line with current legislation, regulations and guidelines.
a. All written records including: Patient log books (day books), telephone logs, laboratory report copies, should be in the laboratory but must be stored in a secure place. b. Reporting of all procedures should be in standard format to include unique patient identifiers and the identity of the operator, as well as witnesses where relevant, and should be signed and dated. c. Reports or daybooks should identify batches of media or reagents used. reporting forms should be available in the laboratory. e. Records associated with sperm donation must be strictly controlled in line with current HFEA guidance. Donor codes and corresponding names must be kept in a secure area. f. All computer programs containing clinical information should be password protected and access to computer records should be strictly controlled.
d. The laboratory manual, containing all written procedures and all standard
Computer records should be backed-up on a regular basis. All records should be securely stored with a copy of the data being kept in fireproof container or approved remote location. 4.2 Retention and storage of samples, records and archives Minimum recommendation for the retention of patient records and specimens must adhere to current legislation and guidelines from the Royal College of Pathologists (RCPath). These are defined both for specimens and records in Appendix A4. 4.3 Traceability Documented procedures should be established for identifying any sample through all of its processes including: Collection Processing Storage Transport Receipt
There must be an effective system that enables traceability of donor tissues/cells back to the recipient and vice versa. Similarly centres should maintain internal records, which enables two-way traceability from sample collection to disposal or treatment, including an audit trail between donor and recipient. 5 Management Review
5.1 Quality Review (annual performance review) All centres should review the quality of all activities on a regular basis. As part of the evaluation cycle, it is sensible for laboratories to identify several easily measurable performance criteria or indicators and include these in annual quality review. Centres should provide evidence of the assessment of the entire management system, including: a. Resources: Staffing levels (changes in personnel, attendance records), staff satisfaction, training, finance, equipment, facilities, activity b. Delivery of service to users (user satisfaction, complaints) c. Audit of processes d. Reports by external bodies e.g. HFEA, CHI e. External quality assurance schemes, internal quality control f. Cryostorage review Measurement of performance is discussed in more detail in section H (Evaluation and Quality Assurance).
References
Burnett D. (2002). ACB venture publications. ISO 9001:2000 Quality management systems Requirements ISO/IEC 15189:2002 ISO 10013:1995 (E). Guidelines for developing quality manuals
Association of Biomedical Andrologists (http://www.aba.uk.net) Guidelines for good practice RCPath (1999). RCPath and IBMS Clinical Pathology Accreditation (CPA) UK Ltd. Standards for the Medical Laboratory (2002)
Personnel
1. Laboratory Management and Professional direction should be carried out by a scientist from a relevant discipline with delegated authority. The scientist may be either a Consultant Clinical or Biomedical Scientist or other scientist with a minimum of 8 years of relevant experience. 2. If such an individual is not available, then centres should seek the direction from a scientist at another centre. This should be carried out by formal arrangement with an appropriate contract and take account of the need to be named on the centres HFEA license to permit access to confidential information, where appropriate. 3. There should be adequate numbers of staff for the laboratory workload (approximately 1.0WTE per 1000 specimens). Centres providing a storage service for oncology patients should be able to provide cover for out of hours emergencies. 4. One member of each laboratory should have received formal training in semen analysis e.g. through the ACE certificate and/or ABA or ESHRE basic semen analysis courses. This should be passed to other staff members in a structured way. 5. Centres providing sperm storage should be fully trained in the safe use of cryogenic equipment, including pressurised nitrogen delivery vessels, nitrogen dewars and if necessary nitrogen vapour storage systems. 6. All new staff should undergo a comprehensive orientation and induction programme. 7. All staff should undergo regular appraisal/joint review and keep and maintain a personal development folder, documenting all relevant training, whether it is in-house or external. 8. There should be sufficient support staff (e.g. secretarial and administrative) to meet the needs of the service. 9. There must be adequate cover for staff holiday/sickness and by fully trained personnel. 10. There should be an ongoing relevant and funded training program for scientific staff including the opportunity to attend relevant clinical and scientific meetings.
References
Burnett D. (2002).. ACB venture publications Employment Handbook, the A-Z of work, ACAS (www.acas.org.uk) Bjorndahl L et al (2002). Hum Reprod. 17, 1299-305. http://ace.ivf.net/ace/training.php
Premises and Environment
Generally, the premises and environment should be designed and constructed to a specification, which suits its intended purpose. The main considerations for the facility are the well-being of staff and patients, the maintenance of quality of cells or tissues being processed and its general suitability for the activities required of it. 1. The andrology laboratory should provide adequate space for the levels of equipment and activity within it. 2. The laboratory should be secure and should be designed to minimise traffic in work areas. 3. Laboratory security must take account of the need for environmental control, safety and confidentiality. 4. Back up power supplies should be provided for all critical items of equipment, including incubators, freezers and monitoring equipment. 5. Equipment should be used within sufficient and safe operating space. 6. Floors, walls and ceilings must have non porous surfaces that can be cleaned easily. 7. There should be clear separation between disciplines and between laboratory and office areas. 8. Attention should be paid to general working conditions, such as bench and seating height, air conditioning and lighting. Workstations must comply with Health and Safety Executive (HSE) regulations for Display screen Equipment (DSE). 9. Specimen production/collection areas should be designed and equipped with careful consideration to the following: a. The clutter free and safe decontamination b. The safe delivery of samples c. The comfort, privacy, security and safety of patients d. The security and safety of staff e. Access for disabled persons f. Requirements for couples g. The need for adult stimulation 10. There must be secure designated areas for the storage of laboratory records 11. All areas used for the delivery and processing of samples must provide for clutter-free and safe decontamination. 12. Processing of sperm for cryopreservation must take place in a separate designated clean area and in a class II or laminar flow cabinet. 13. Storage of frozen cells and tissues should be carried out in a separate designated secure and safe facility. Risk assessments should be carried out with respect to the following: a. The location which must allow the safe delivery of liquid nitrogen, with respect to staff and members of the public.
b. There must be low level extraction and air flow through the room which is adequate for the volume of nitrogen stored. c. In the event of significant spillage, emergency procedures must be in place to deal with nitrogen hazards e.g. burns and asphyxiation and allow the increased volume of gas generated to escape. d. The storage room must have an oxygen depletion monitor, linked to an external warning system. The oxygen detection cell must be regularly replaced in accordance with manufacturers instruction.
References
The workplace (Health, Safety and Welfare) regulations 1992 ISO/DIS 159190 - Medical laboratories requirements for safety management Health and Safety (Display Screen Equipment) Regulations 1992: guidance on regulations ISBN 07176-0410-1 Biological agents Managing the risks (2003). HSE books Cryoservice data sheets www.cryoservice.co.uk
Equipment, information systems and reagents
Documented procedures must be in place to manage any piece of equipment or reagents, which have a direct impact on the quality of the laboratory output. 1 General
a. Any equipment or reagent, which comes into contact with patients or patients stored
gametes or embryos, must comply with EC Medical Devices directives (Medical Devices Regulations 2002). b. Media to be used for the preparation and culture of gametes must be manufactured under conditions observing good manufacturing practice (GMP). Any additional reagents or media should be of purity appropriate for the purpose. c. Any laboratory using equipment or reagents, which have been modified in any way and used not in accordance with manufacturer recommendation, must have documented evidence of compliance with regulation for in vitro manufacture. Examples of this would include home made cryoprotectant or sperm preparation media. 1.1 Equipment a. All equipment should be regularly serviced and calibrated and this must be supported by relevant documentation. b. Laboratory equipment must be fit for its purpose and easy to clean and disinfect. c. There should be a procedure in place for the decontamination of all items of equipment prior to service and maintenance. d. Critical pieces of equipment such as incubators, refrigerators and monitoring equipment must be on emergency power supplies. e. Laboratories using any alternatives to those recommended below must provide full clinical validation. 1.2 Media and Reagents a. Media must be stored according to manufacturers instructions b. All seals and packaging on commercial products should be checked on arrival. c. Certificates of analysis and details of quality control measures should be supplied by manufacturers and checked for correspondence with the batch delivered. d. Culture medium or cryoprotectant should not contain any material of animal origin. e. Where it is necessary to add components to commercially supplied media in the laboratory, it must be understood that this invalidates QC testing carried out by the manufacturer. 2 Semen Analysis
All semen analyses should be carried out according to the World Health Organisation (WHO, 1999). In that: a. Phase contrast microscopes should be used for all examinations of live sperm. b. Heated microscope stage should be used for all examinations of sperm motility.
c.
Multichannel counters. Should be used for performing differential counts such as those for motility or morphology.
d. Bright field microscopy should be available for the examination of sperm morphology. Slides should be stained using WHO recommended methods (e.g. Papanicoloau). e. Positive displacement pipettes should be used for accurate dispensing of semen. f. Haemocytometer should be used for assessing sperm concentration. should be used for the assessment of sperm motility. h. Mar or Immunobead tests should be available for the assessment of antisperm antibodies. Daily Temperature logging is required for the following items of equipment: a. Heated microscope stages b. Incubators c. Heating blocks d. Refrigerators and freezers Laboratories using any alternatives to those recommended above should provide full justification/validation. 3 Sperm Cryopreservation validated and batch numbers recorded. Home-made media should not be used unless there is documentary evidence supporting its manufacture according to GMP. b. Marker pens, printed adhesive labels used to mark frozen stored samples must be able to withstand ultralow temperatures (-196C) and long term storage. Markings must not be affected by immersion in liquid nitrogen (see F5). c. Freezing equipment There should be full validation of the sperm cooling rate for cryopreservation whether using the nitrogen vapour method (Sherman, 1963) or using a controlled rate freezer. Technical failures of controlled rate freezers should be reported to the Medicines and Healthcare products Regulatory Agency (MHRA). d. Containment or plastics for the cryopreservation of sperm must be used according to manufacturers instruction. The integrity of plastic-ware should withstand long-term storage at ultralow (liquid nitrogen) temperatures. Plasticware should be sterile and have an effective sealing method, to prevent contact between liquid nitrogen and the frozen contents. e. Vacuum lined storage vessels (dewars) should be used for storing sperm in liquid nitrogen or the vapour phase of nitrogen. These should be carried out in suitable vessels purchased from reputable manufacturers. They should be regularly inspected and tied into a suitable equipment replacement cycle. Any catastrophic vessel failure should be reported to the MHRA.
g. Slides with 22x22 mm coverslip or a specialised chambers with a fixed 20m depth
a. Cryoprotectants and other media used in sperm processing and freezing must be
f.
Alarms must be in place for storage dewars, vapour refrigerators and for room oxygen level. These should be linked to a suitable external warning system such as an autodialler or hospital fire alarm panel.
Laboratories using any alternatives to those recommended above should provide full justification/validation.
References
EC Medical Devices Directives In Vitro Diagnostic Medical Devices (IVD) Directive (2003). World Health Organisation (1999). ISO/DIS 159190 Medical laboratories requirements for safety management HSE (2003) Biological agents Managing the risks www.mhra.gov.uk
E
1
Pre- Examination Processes
Information for Service Users
1.1 Referring clinicians All andrology laboratories storing centres must provide comprehensive information for clinicians. This should include: Introduction to the service Location and useful contacts Key personnel Normal working hours Services provided (repertoire) Overview of procedures used for semen analysis and sperm storage Where relevant, how to refer a patients for: - Diagnostic Semen Analysis - Post Vasectomy Semen Analysis - Post Chemotherapy Semen Analysis - Sperm storage (normal and emergency) - Assisted Conception Selection/referral criteria Consent and the HFEA (where appropriate) Provision of information for the patient (see below) Instruction for delivery of the specimen Procedures for repeating semen analysis (where applicable) Results and interpretation of diagnostic tests Funding (where applicable) Storage specific procedures: - patients who are unwell/dying - Notification of patients death/change of address
1.2 Patient Information (a) Patient information for semen analysis should cover the following: A brief outline of the tests carried out and why they are necessary How the samples are collected and delivered both for samples produced on and off site, including: - The required period of sexual abstinence - The need for personal hygiene - The need to use the specimen container provided - Transportation to the lab - The need for accurate labelling. Where the andrology laboratory is located How the patient obtains an appointment Why repeat tests are sometimes requested How the result is obtained Contact details Separate information should be available for patients with retrograde ejaculation Account should also be taken of patients with special needs e.g. disabled, visually impaired, hard of hearing, non-English speaking
(b) Patient information for sperm storage (sperm banking) should cover the following: A brief outline explaining exactly what sperm storage is and who it is appropriate for How the samples are collected and delivered, both those samples produced on and off site Where the andrology laboratory is located How the patient obtains an appointment Payment details if relevant The process of sperm storage, consent, sample production, processing and storage
Duration and conditions of storage Registration of fathers in posthumous treatment Special information for adolescents (oncology patients) How frozen sperm are used in ART to achieve a pregnancy Family planning, during and immediately after chemotherapy (oncology patients) Counselling Follow-up semen analysis (oncology patients) Contact details
(c) Information for prospective sperm donors should cover the following: 2 Why sperm donors are required and what the donations are used for How sperm donors are selected What screening tests are performed before becoming a donor What is involved in the donation process Sperm donation and legal requirements How to become a donor, contact details and where to find the laboratory Request Forms
Should be explicit and unambiguous (a) Request forms for semen analysis should include the following: Contact details for the patient, referring clinician and GP Address of the laboratory NHS number (if available) Details of investigations required Details of previous investigations/tests including screening for infectious diseases Relevant clinical details and history Notification if patient constitutes an infection risk
(b) Request forms for sperm storage should include the following: Contact details for the referring clinician and GP Contact details for the patient NHS number (if available) Address of the laboratory Reason for storage Diagnosis (if relevant) Therapy details (if relevant) Relevant clinical details and history Results of screening for HIV and hepatitis B and C (if available)
Note: Referring oncology centres should be aware that any patient with extremely poor prognosis would require legal consent if he intends his partner to use his gametes posthumously. In addition, any patient who wishes to register as the legal father of any child born posthumously must complete the relevant consent form.
Specimen Collection
a. Standard specimen containers should be wide mouthed and tested for toxicity on sperm (WHO, 1999). b. Alternative methods of sample collection should be available, in particular non-toxic condoms. c. Samples should not be collected using the withdrawal method (coitus interruptus). d. Centres providing a treatment or storage services must have facilities for sample production. These should be private, comfortable and provide basic washing facilities. These should not be a staff or public toilet.
e. Where there is then need to establish a chain of custody e.g. legal/forensic cases, samples must be produced on-site. f. Patients producing samples off-site should follow the instructions to patients and attend the andrology centre within one hour of its production. g. Sample pots must be labelled with at least 3 unique identifiers. 4 Specimen Reception
There should be adequate facilities and procedures for specimen reception. For each patient, centres must obtain information on: a. Whether the sample was complete. b. Whether the sample was produced on or off site. c. Whether instructions to patient for specimen production were carefully followed . d. The duration since previous sexual activity resulting in ejaculation. e. Any recent illness or relevant medication. f. Centres should have procedures in place for decontamination of the specimen production room between patients. g. Staff must ensure that sample pots are labelled with at least 3 identifiers. h. There should be a witnessing procedure in place in order to verify that the details on the specimen pot, request and report forms all correspond. i. Unlabelled samples arriving at the laboratory should be discarded. j. All samples should be given a unique accession number. ___________________________________________________________________ References
Burnett D. (2002). A practical guide to Accreditation in laboratory medicine. ACB venture publications World Health Organisation (1999). Press syndicate of the University of Cambridge
F
1 Laboratory Processes
Examination Processes
1.1 Diagnostic Semen Analysis Semen analysis should be carried out according to the World Health Organisation (WHO, 1999). In that: a. All semen analysis should be carried out using phase contrast microscopy. b. Macroscopic measures including pH, volume, liquefaction and viscosity are routinely recorded. c. Sperm motility analyses should always be performed at a standardised temperature, preferably using a heated microscope stage at 37C. d. Four motility grades should be reported (a=rapid progressive, b=medium progressive, c=non-progressive, d=static). e. Vitality testing using either Eosin/Nigrosin or the Hypo-osmotic swelling (HOS) test should be available for samples with low motility. f. Sperm morphology should be performed using bright field microscopy at x1000 magnification (under oil) and preparations stained using the Papanicoloau stain or similar recommended stain. g. Sperm concentration should be assessed using the Haemocytometer method. Any alternative to this must be validated against the Haemocytometer for samples at both high and low concentration. h. Antisperm antibodies should be assessed using the Mar or Immunobead tests. Clinics who do not perform this test routinely should have referral arrangements with another laboratory in place, should the test be requested. i. If diagnostic sperm preparation is performed, batch numbers of media must be routinely recorded. Results should be validated against clinical data. 1.2 Post Vasectomy Semen analysis (PVSA) Post vasectomy semen analysis should be carried out according to the guidelines published by the British Andrology Society (BAS, 2002). Briefly: a. Patients should wait at least 16 weeks before attending for PVSA. b. Semen samples should be collected and received as described in E3 and E4 c. Unlabelled specimens must be discarded. compliance. Postal regulations for pathological specimens must be adhered to (see F6.1). End users must be notified of the limitations of the test in this instance. e. A wet preparation should be examined using phase-contrast optics. f. Confirmatory centrifugation and examination of the entire cell pellet should take place if the wet preparation is found to be sperm-negative. d. Postal samples are only permitted if there is significant risk of patient non-
g. All end-users must be notified and be in agreement with any centre which performs PVSA to a lesser standard.
1.3 Aseptic techniques for sperm processing a. Protective measures should be in place to ensure aseptic conditions for gametes during processing for treatment or cryopreservation. b. Processing of gametes and embryos for clinical use must be carried out under conditions of suitable air quality, (i.e. in Class II cabinets or equivalent as a minimum). c. Material from only one patient must occupy the processing area at any one time. processing area and of the background air. e. Care should be taken when transferring gametes or embryos to cryo straws or other cryo-containers, to minimise the risk of contaminating the outside of the container. d. Particle counts must be carried out regularly to verify the quality of air in the
1.4 Sperm Preparation Sperm preparation methods are designed to take sperm from the seminal fluid and place them in an artificial media which will support sperm function. The aim of sperm preparation is that the resulting suspension is enriched by sperm with improved motility, morphology, DNA integrity and is free from seminal plasma, non-sperm cells and contaminating microorganisms. a. All media used for sperm preparation (density gradient media, sperm buffer) must be validated and batch numbers recorded. Home-made media should not be used unless there is documentary evidence supporting its manufacture according to GMP. b. The sperm preparation method, whether density gradient centrifugation or swim-up should be validated in terms of effectiveness. Effectiveness should be measured by post-preparation sperm motility and outcome of ART (assisted reproductive techniques) procedures. c. All semen parameters pre- and post sperm preparation should be recorded using the methods described above (WHO, 1999). d. Diagnostic sperm preparation should be clinically validated in that thresholds for sperm yields should be related to clinical outcomes in ART procedures. Reports should state starting volume and resuspension of sperm should be in a standardised volume. Sperm concentration should be reported as millions/ml. e. Sperm preparation for assisted reproduction must use sterile media and consumables. Operators must be trained in and use suitable aseptic techniques and preparation should take place in an appropriate standard of air quality (see F3b). f. Density gradient media used assisted reproduction procedures must be licensed for used in ART and should be based on the silane-coated silica particles. PVP based media (Percoll) must only be used for diagnostic purposes.
g. There should be suitable decontamination procedures between patients.
h. Sperm preparation for treatment must involve verification or witnessing of patient

identifiers at every stage where the gametes are transferred from one container to another e.g. from specimen pot to centrifuge tube, to a further centrifuge tube and into either insemination catheter or dish (HFEA, 2004).
1.5 Sperm cryopreservation and storage for patients and sperm donors 1.5.1 General Centres must be able to demonstrate to service users that methods used for sample processing, freezing and storage are optimised and validated. Reduction in post thaw semen quality should not be attributable to technical limitations. a. All samples for cryopreservation should have their quality assessed using WHO methodology (outlined in F1). b. Methods of sperm processing and freezing must be validated. c. All issues surrounding the processing of patients, the provision of information and consent must be carried out in accordance with current HFEA guidance. d. There should be adequate decontamination procedures for controlled rate freezers, nitrogen vapour freezers and liquid nitrogen dewars. e. There should be adequate separation between diagnostic and sample processing areas. f. Centres must avoid processing more than one patient sample at any one time. manufacturers instruction. The integrity of plastic-ware must withstand long-term storage at ultralow (liquid nitrogen) temperatures. h. Plastics must be sterile and have an effective sealing method, to prevent contact between liquid nitrogen and the frozen contents. i. Frozen samples must be labelled with at least 3 identifiers. Transfer of processed sample from specimen pot to cryovials or straws must be witnessed/verified by another member of staff (HFEA, 2004). j. k. Cryopreserved sperm and embryos should not be placed in the same storage vessel. Patients who have tested positive for HIV and/or Hepatitis B and/or C must have their sperm stored separately from those who have tested negative. Where screening results are unavailable due to delay, samples must be kept in separate holding tanks until the result is obtained. No more than 1 patients samples should be held in this holding tank at any one time. Centres must ensure they provide sufficient holding tanks in line with the likely workload. l. Plastic straws, which have become broken during storage in liquid nitrogen should be recorded and reported as an incident. m. Long-term sperm storage must take place at temperatures lower than -140C. Centres should provide documentary evidence that samples have been maintained at suitable storage temperatures for the duration of the storage period.
g. Sperm must be frozen in suitable containment or plastics and according to
n. Sperm storage in liquid nitrogen must be carried out in suitable vacuum lined storage vessel (dewars). o. Vessels should be purchased from reputable manufacturers and tied into a suitable equipment replacement cycle. p. Centres storing in the liquid phase should demonstrate that the risk of exposure of frozen contents to the liquid nitrogen is negligible. q. Centres storing in the vapour phase of nitrogen should ideally do so in specialised vapour vessels with autofilling. However, adaptation of existing liquid dewars may be used providing that rigorous procedures must be implemented to maintain an appropriate liquid level. r. Centres should perform regular audit to demonstrate an effective inventory control system. 1.5.2 Storage patients (oncology) a. Storing centres should have open and continuous dialogue with service users regarding the quality and level of service provided. There should be a formal agreement between the two, setting out contractual obligations of the service providers and of the users. b. As part of the evaluation cycle, storage providers should provide an annual report to service users, as part of its management review. c. All centres should provide comprehensive storage information for end-users (patients and clinicians). d. There should be a strict referral procedure for sperm storage and this should include the emergency referral for oncology patients. e. Patients must receive the opportunity to read and digest relevant information. f. Information should be re-emphasised in an information counselling session. produce a specimen. h. Clinics should offer routine follow-up once treatment is completed which may include include: Semen analysis Counselling Consultation with clinical staff Clinics should plan ahead and ensure that the service copes with user demand. g. Clinics should offer alternative sample collection method should the patient fail to
i.
1.6 Sperm Donors a. All centres should provide comprehensive information for potential sperm donors. b. As a minimum standard, all sperm donors must be screened according to the guidelines laid down by the British Andrology Society (BAS, 1999). c. All semen analyses performed on potential or existing donors should be carried out according to those outlined in F(1). d. All record keeping, consent for use and storage of donor sperm must adhere to the HF & E Act 1990 and the current HFEA code of practice.
e. The entire donor stock in a sample dewar should be discarded in the event that any donor seroconverts for HIV or Hepatitis B or C during the quarantine period. f. Sperm donor samples should be processed according to good manufacturing practice (GMP). g. Cryopreservation should follow the guidance outlined above. h. Supplying centres should supply post thaw information with every ejaculate. i. j. Recruiting/supplying centres must only compensate donors according to HFEA guidelines. Centres must have suitable procedures in place for recording pregnancies, and pregnancy outcome from each cycle of treatment with donor sperm. This should be demonstrated through a regular audit cycle.
1.7 Cryostorage Emergency a. There should be emergency procedures which respond to: Liquid nitrogen leak or spillage Freezer failure or malfunction Loss of liquid nitrogen supply b. There must be suitable early warning systems, procedures and staff cover to deal with out of hours emergencies. c. All centres must have spare storage capacity in the event of a vessel failure. have alarms linked to an external warning system. e. Centres storing in automated vessels should be aware of the potential pitfalls of automation, including the failure of liquid nitrogen supply. Procedures should be in place for dealing with these. 2 Management Processes d. All vessels should be monitored for either temperature or liquid nitrogen level and
2.1 Packaging, labelling and transport of specimens Packaging and marking materials must be robust and suited to the process they are used for. Samples should be labelled with a minimum of 3 identifiers, one of which should be the unique sample accession number. 2.2 Postal samples It is extremely likely that the quality of any sample, which is placed in the postal or internal transport system, will be compromised. For example any delay between sample production and eventual analysis and the exposure to extremes of temperature would reduce the clinical value of any testing procedure. Therefore, in general, postal samples should not be accepted unless specifically requested by the clinical user of the service. In this case: a. Postal or transported samples should only be accepted if accompanied by documentation verifying a chain of custody.
b. Postal samples should only be sent 1st class and should comply with IATA 602 regulations. c. Samples sent through hospital transport should have labels or package inserts which include a full description of the contents, the full postal address (of the sender and receiver), the date and time of sample collection and advice on handling or the presence of any hazards. d. Postal samples must follow current guidelines for the consignment of infectious material by post (HSE, 1992, 1995) which can be obtained by the Post Office and the WHO guidelines for the safe transport of infectious substances and diagnostic specimens (WHO, 1997). e. Containers used for postal or transported samples must be designed specifically for the purpose. They must be secure and prevent leakage or spillage. They must not compromise sample quality, allow contamination or pose a health and safety hazard to staff and public. f. Centres should specify its acceptance criteria for such specimens and document those, which are rejected or not analysed. g. Postal samples may only be used for diagnostic purposes and to establish the presence or absence of sperm (e.g. PVSA). Users of such a service must be informed of the limitations of the information obtained from postal specimens. 2.3 Transport of Frozen Samples a. Frozen donor or patient samples should be transported using a dry shipper which has been designed specifically for this purpose, holding samples at temperatures as cold as 180C. Transport on dry ice (-78.5C) should be avoided as this may compromise the quality of the frozen material. b. Centres must ensure that any materials used to mark frozen stored samples (marker pens, printed adhesive labels) must be able to withstand ultralow temperatures (196C) and long term storage. Markings must not be affected by immersion in liquid nitrogen. c. Documented procedures must be in place for the carriage of frozen specimens, ensuring that samples are accompanied by relevant paperwork. Documentation should also be available to allow patients to take responsibility for the transport of their own specimens. d. When transporting a patients stored material, centres should be mindful (and inform patients) of the risks associated with dry shipper failure and should avoid the transfer of all of their samples at any one time.
Risk Management Procedures
3.1 General a. All centres should have risk management policy and procedures to cover all potential hazards in andrology.
b. All centres should have risk assessments for each procedure and working area. c. Centres should take advice on infection control when dealing with biohazards. d. All centres must have COSHH assessments for chemical hazards. e. Risk and COSHH assessment should be tied in to appropriate controls (i.e. Standard Operating Procedures) to deal with associated hazards. 3.2 Health and Safety a. Laboratory coats should be worn at all time in the laboratory. Disposable aprons may be worn in addition to permit the wearing of laboratory coats in other areas (e.g. waiting room, specimen production). Aprons must be removed on leaving the laboratory. b. Laboratory coats must not be worn in area of food preparation or consumption. c. Powder free gloves should be worn at all time during the examination of semen. Attention should be paid to staff with latex allergies so that alternatives may be found (e.g. nitrile gloves). d. All personnel should follow a prescribed hand washing procedure when leaving the laboratory. e. Personnel should not use strong smelling cosmetics or perfumes. f. There must be no eating, drinking, chewing, smoking, and no storage of food, drink, smoking materials or personal medication in the laboratory area.
g. All biological material should be treated as a potential source of infection. h. All centrifugation of biological material should be carried out in sealed vessels, within
closed centrifuge buckets. i. All disposable material must be disposed of immediately after use in suitable containers. Needles and other sharp materials should be disposed of in appropriate containers with suitable precautions. j. Where patients who are known to carry HIV, hepatitis B or C are to be treated, attention must be paid to the guidance from the Advisory Committee on Dangerous Pathogens with regard to containment, and a local risk assessment must be carried out to establish safe and suitable procedures. k. Material from patients who present an infection risk should either be processed in a separate area, dedicated to the purpose, with separate, dedicated equipment, or, at a time when no other procedures are to be carried out. Sufficient time must be allowed for thorough decontamination before further procedures are allowed to continue. l. Where material from patients who represent an infection risk is to be cryopreserved, attention must be paid to any possible risk of transmission in processing and storage areas. m. Material from patients who have screened negative in testing for infectious agents must be stored separately from those who present known risk of infection, or whose status is unknown.
n. There should be a strict procedure for disposal of waste material from high risk cases.
References
British Andrology Society (1999). Hum Reprod 14, 1823-1826. Clarke G (1999) Human Reproduction, 14, 2941-2943. Cryoservice data sheets www.cryoservice.co.uk Hancock P and McLaughlin E. (2002). J Clin Pathol. Nov 55, 812-816. Health and Safety Executive (1992). Health and Safety Executive (1995). Advisory Committee on Dangerous Pathogens. HSE books. Health and Safety Executive (1998). UK 5 steps to risk assessment. (www.hse.gov.uk) Health and Safety Executive (2003) Biological agents Managing the risks. Henry MA, Noiles EE, Gao D et al (1993). Fertility and Sterility 60, 911-918. HFEA (2002). Letter from the chair regarding witnessing. HFEA (2004) Sixth code of Practice Howell S & Shalet S (1998) Endocrinol. Metab. Clin. North. Am. 27: 927-943. http://www.asymptote.co.uk/ IATA 602 (2001). IATA Packing Instruction 602 -2001 ISO/DIS 159190 Medical laboratories requirements for safety management Joint Council for Clinical Oncology (1998). Keel,B.A., Quinn,P., Schmidt,C.F. et al (2000). Hum. Reprod., 15, 680-686. Kim LU, Johnson MR, Barton S et al. (1999). AIDS, 16, 645-651. McLaughlin EA, Ford WCL & Hull MGR (1990). Human Reproduction 5, 734-738. Mortimer D (1994). Practical laboratory Andrology. Oxford University Press. Mortimer D (2000). J Androl.2, 357-66. NHS Executive (1997). Department of Health. United Kingdom. Ord T, Patrizio P, Marello E et al R (1990). Human Reproduction 5, 987-989. Parinaud J, Richoilley G, Moutaffian H et al R (1996). Int J Androl 19, 103-108. Sakkas D, Manicardi GC, Tomlinson MJ et al (2000). Human Reproduction 15, 1112-6. Saritha KR and Bongso A (2001). J Androl 22, 857-862. Seaman, E.K., Goluboff, E., BarChama, N. et al (1996). Fertil. Steril., 66, 662-665 Sherman JK (1963). Fertility & Sterility 14, 49-64. Tomlinson MJ and Pacey AA (2003). Hum Fertil (Camb).6:100-5. Tomlinson MJ, Moffatt O, Manicardi G et al (2001). Human Reproduction, 10, 2160-2165. Tomlinson MJ, Powell G, Turner J et al (2001). Human Reproduction. 16 1, 121-124. TUC guide to health and safety (1997). Hazards at work, The working environment and welfare. Workplace, Health, Safety and Welfare, a short guide for managers. HSE, UK. World Health Organisation (1997). WHO/EMC/97.3 World Health Organisation (1999). Press syndicate of the University of Cambridge
G
1 Reporting Results
The post examination phase
Most centres will issue a number of report types. Reporting of results must be sympathetic to the category of patient under examination and indeed the needs of the clinical user who will receive the report. For example, a semen analysis result, which falls below the accepted normal threshold may be a concern to infertility patients but may be more than satisfactory if the patient just happens to have received chemotherapy. Insightful interpretative comment and summary is extremely important in such cases, not withstanding sufficient clinical history being available. Expert fertility clinicians may require a low level of comment, summary and interpretation of the report, yet a much higher level may be required by others (e.g. general practitioner, oncologist, urologist). Any reporting from licensed procedures must not take place without the written consent from the patient concerned. Report types will include: Diagnostic Semen Analysis reports for infertility patients Diagnostic Semen Analysis reports post vasectomy Diagnostic Semen Analysis reports post chemo or radio therapy Sperm storage report - Pre-freeze (summary of sperm quality and quantity frozen and stored) Sperm storage report - Post thaw analysis prior to treatment
1.1 The Written Report a. All centres must have a standard reporting format for all examinations. b. Report format must be clear and concise and contain results on all of the tests performed. c. A clear and concise comment using World Health Organisation terminology should be used to summarise the findings. All unusual findings must be reported. d. WHO terminology should be interpreted for those service-users who are unfamiliar with it e. WHO Reference ranges should be provided on the report. Centres should provide validation for any reference range which is not published by the WHO (WHO, 1999). f. End users must be made of aware of the clinical value of the test and of its limitations. They must also be informed of any changes in laboratory methodology and/or output. g. There should be a written procedure for verifying results and checking prior to despatch. h. End users must be made aware of the limitations of the test and the report should include contact details for obtaining further advice. 1.2 The Telephoned report a. Telephoned results will only be given to the appropriate Medical Practitioner
(usually whoever is responsible for the care of the patient) and only in exceptional circumstances (see below). b. Exceptional circumstances should be defined and documented by operating procedures and should be authorised by the Medical Director of the appropriate referring service. c. Clinical staff requesting telephoned results should provide 3 patient identifiers and their hospital extension number/location. d. All telephone communications, especially related to clinical matters should be recorded in a telephone log book. 2 Clinical Interpretation delegated authority from the person responsible (Licensed centres) and/or the Clinical Director. Centres should distinguish between clinical interpretation to clinical users of the service and patients receiving test results. Appropriate scientist in this case may be either a Consultant Clinical or Biomedical Scientist or other scientist with a minimum of 8 years of relevant experience. b. If such advice is not available, then centres may seek the advice from a consultant scientist at another centre. This must be carried out by formal arrangement and/or contract. c. If interpretation is required prior to infertility treatment, then this should be carried out in conjunction with an experienced state registered embryologist.
a. Clinical interpretation should be carried out by an appropriately trained scientist with
Evaluation and Quality Assurance
Evaluation equates to measurement and analysis of performance and is synonymous with quality assurance. In general, the requirements of evaluation are to ensure that centres are able to assess quality and can continue to provide a service, which meets the needs and expectations of service users. 1 Audit
Audit is central to the evaluation process and is defined as the systematic, independent and documented process for obtaining and evaluating evidence and objectively evaluating it to determine the extent to which the pre-defined criteria are fulfilled (ISO 9000:2000). Documented procedures must be established for conducting internal audit of all applicable laboratory processes. These audits should be scheduled in advance and include 3 categories of analysis: i. Vertical Audit - Examination of all elements associated with a testing or treatment
procedure to check that these elements conform to the pre-exam, exam and post exam procedures. These should be carried out for: Diagnostic semen analysis (infertility or PVSA) Sperm storage for patients (HFEA licensed centres) Sperm donor processing and storage through to DI treatment (if relevant)
Examples of vertical audits are given in appendix H1. ii. Horizontal Audit - Examinations of documentation, aspects of the TQM system or any
process to determine whether the elements are actually in place or indeed comply with predetermined standards at any specified moment in time (i.e. snapshot). An example may be to take the vertical audit one step further and determine whether on a given day, all pieces of equipment used for in a procedure had been temperature checked, calibrated and properly serviced. iii. Examination Audit - Examination/witnessing of an individual performing a test/treatment procedure e.g. semen analysis. Ensuring that the procedure is followed correctly and that the individual appears to understand the requirements of that procedure. For each audit there should be: A description of each step of the audit process A record of any deficiencies identified A suggestion of possible corrective action
The results of audits should be discussed within the management review.
Assessment of user satisfaction and complaints
The purpose of assessing user satisfaction and monitoring complaints is to establish that the service provided by the laboratory meets the needs and requirements of users. This may included the use of patient and referring clinician questionnaires as part of the evaluation process (user satisfaction surveys). Centres must ensure that any review is fully inclusive and involves General Practitioners, Obstetrician/ Gynaecologists, and those referring for sperm storage such as Oncologists, Haematologists, Urologists and General Surgeons. 3 Performance Indicators
Centres must have procedures in place for the continuous evaluation of service quality. Key quality indicators should be identified, monitored and any deficiencies acted upon as part of the improvement cycle. Service users should be kept informed of performance via the annual management review (see A5). Chosen performance indicators should be easily measurable and give an overall view of the quality of both the laboratory management and the laboratory product. The quality manager would be responsible for collating performance indicators on a regular basis and presenting them to management of the parent organisation. a. Management indicators could include: Staff absences Staff satisfaction/Staff turnover Training and appraisal targets Waiting times Turnaround of reports Referral rates Activity b. Laboratory performance indicators Review of data logs from laboratory equipment Internal quality control External Quality Assessment c. Clinical performance indicators (if applicable) Quality of donor sperm supplied by the centre Quality of donor sperm purchased from other centres Quality of sperm prepared for insemination 4 Internal Quality Control
Internal quality control procedures are regular exercise undertaken by staff to continuously assess the laboratory work and emergent results to determine whether they are reliable. a. There should be a program of internal quality control (QC) for the laboratory to cover the assessment of sperm concentration, motility and morphology. b. The laboratory should have a procedure for the review of QC with both staff and management. Any decisions taken for corrective action should be recorded, monitored and acted upon. c. IQC records should be kept permanently.
External Quality Assurance (EQA) Schemes
EQA is a system of objectively checking laboratory results by an external agency. The main objective of this is to bring about lab to lab comparability. If EQA results are not consistent with targets a retrospective investigation should be carried out. a. The laboratory should be a member of the UKNEQAS scheme for sperm concentration, motility, morphology and if appropriate antisperm antibodies. b. The laboratory should have been a scheme member for at least one year and made regular returns. All results should be available for inspection. c. The laboratory should have a procedure for the review of EQA with both staff and management. Any decisions taken for corrective action should be recorded, monitored and acted upon. Evidence of EQA review should be available for inspection. d. EQA records should be kept for a minimum of 2 years.
References
1. Association of Clinical Embryologists http://ace.ivf.net/ace/training.php. 2. Asymptote Ltd (2001) http://www.asymptote.co.uk. 3. Biological agents Managing the risks (2003). Health and Safety commission, Advisory committee on Dangerous Pathogens, HSE books. 4. Bjorndahl L, Barratt CL, Fraser LR, Kvist U, Mortimer D (2002). ESHRE basic semen analysis courses 1995-1999: immediate beneficial effects of standardised training. Human Reproduction 17, 1299-305. 5. British Andrology Society (1999). Guidelines for the screening of semen donors for donor insemination. Human Reproduction 14, 1823-1826. 6. Burnett D. (2002). A practical guide to Accreditation in laboratory medicine. ACB venture publications 7. Clarke G (1999) Sperm cryopreservation: is there a significant risk of crosscontamination? Human Reproduction 14, 2941-2943. 8. Clinical Pathology Accreditation UL Ltd. Standards for the Medical Laboratory (2002) 9. Cryoservices www.cryoservice.co.uk 10. EC Medical Devices Directives (1998). www.fxtrans.com/medical/IVD98-79-EC.pdf 11. Employment Handbook (2003). The A-Z of work, ACAS (www.acas.org.uk) 12. Gingell C,Crosby D, Carroll R (2001). Review of the complications & medicolegal implications of vasectomy. Postgrad Med J 77, 656-9. 13. Hancock P and McLaughlin E. British Andrology Society guidelines for the assessment of post vasectomy semen samples (2002). J Clin Pathol 5, 812-816. 14. Henry MA, Noiles EE, Gao D, Mazur P and Critser JK (1993). Cryopreservation of human spermatozoa. IV. The effects of cooling rate and warming rate on the maintenance of motility, plasma membrane integrity, and mitochondrial function, Fertil Steril 60, 911-918. 15. Health and Safety Executive (1992). Safe working and the prevention of infection in clinical laboratories. Health and Safety Commission. Health and Safety Advisory Committee. HSE books. 16. Health and Safety Executive (1995). Categorisation of biological agents according to hazard and categories of containment. Advisory Committee on Dangerous Pathogens. HSE books (www.hse.gov.uk) 17. Health and Safety Executive (1997). Workplace, Health, Safety and Welfare, a short guide for managers. HSE, UK (www.hse.gov.uk) 18. Health and Safety Executive (1998). 5 steps to risk assessment. HSE, UK (www.hse.gov.uk) 19. Health and Safety Executive (2003) Biological agents Managing the risks. Health and Safety commission, Advisory committee on Dangerous Pathogens. HSE books (www.hse.gov.uk). 20. Howell S & Shalet S (1998) Gonadal damage from chemotherapy and radiotherapy. Endocrinol. Metab. Clin. North. Am. 27, 927-943.
21. http://www.asymptote.co.uk/ 22. Human Fertilisation and Embryology Authority (2004) Sixth code of Practice 23. Human Fertilisation and Embryology Authority (2002). Letter from the chair regarding witnessing procedures in ART. 24. In Vitro Diagnostic Medical Devices (IVD) Directive (2003): In House Manufacture 25. ISO 10013:1995 (E). Guidelines for developing quality manuals 26. ISO 9001:2000 Quality management systems Requirements 27. ISO/DIS 159190 competence 29. Joint Council for Clinical Oncology (1998). Royal College of Physicians and Royal colleage of radiologists of London ISBN 1 86016 071 9. 30. Keel,B.A., Quinn,P., Schmidt,C.F. et al (2000) Results of the American Association of Bioanalysts national proficiency testing programme in andrology. Hum. Reprod., 15, 680686. 31. Kim LU, Johnson MR, Barton S et al. (1999) Evaluation of sperm washing as a potential method of reducing HIV transmission in HIV-discordant couples wishing to have children. AIDS, 16, 645-651. 32. McLaughlin EA, Ford WCL & Hull MGR (1990) A comparison of the freezing of human semen in the uncirculated vapor above liquid nitrogen and in a commercial semiprogrammable freezer. Hum. Reprod. 5, 734-738. 33. Medical Medicines and Healthcare products Regulatory Agency (MHRA). www.mhra.gov.uk 34. Mortimer D (1994). Practical laboratory Andrology. Oxford University Press. 35. Mortimer D (2000). Sperm preparation methods. J Androl 2, 357-66. 36. NHS Executive (1997) Guidance notes on the processing, storage and issue of bone marrow and blood stem cells. Department of Health. United Kingdom. 37. Ord T, Patrizio P, Marello E, Balmaceda JP and Asch R (1990). Mini-Percoll: a new method of semen preparation for IVF in severe male factor infertility. Human Reproduction 5, 987-989. 38. Parinaud J, Richoilley G, Moutaffian H, Vieitez G and Mieusset R (1996). Are the characteristics of spermatozoa in the insemination medium useful for predicting in-vitro fertilitisation results. Int J Androl 19, 103-108. 39. Petersen PM, Skakkebaek NE, Vistisen K, Rorth M & Giwercman A (1999) Semen quality and reproductive hormones before orchiectomy in men with testicular cancer. J. Clin. Oncol. 17, 941-947 40. Ragni G, Caccamo AM, Dalla Serra et al (1990) Computerized slow-stage freezing of semen from men with testicular tumours or Hodgkins disease preserves sperm better than standard vapor freezing. Fertil. Steril. 53, 1072-1075. 41. RCOG (1999) Male & female sterilisation,. London: Royal College of Obstetricians & Gynaecologists
Medical laboratories requirements for safety management
28. ISO/IEC 15189:2002 Medical laboratories particular requirements for quality and
42. RCPath (1999). The retention and storage of pathological records and archives. Report of the working party of the Royal College of Pathologists and Institute of Biomedical Science. 2nd Edition 43. Sakkas D, Manicardi GC, Tomlinson M, Mandrioli M, Bizzaro D, Bianchi PG, Bianchi U (2000). The use of two density gradient centrifugation techniques and the swim-up method to separate spermatozoa with chromatin and nuclear DNA anomalies. Human Reproduction 15, 1112-6. 44. Saritha KR and Bongso A (2001). Compative evaluation of fresh and washed human sperm cryopreserved in vapour and liquid phases of liquid nitrogen. J Androl 22, 857-862. 45. Seaman E.K., Goluboff E., BarChama N. and Fisch H (1996). Accuracy of semen counting chambers as determined by the use of latex beads. Fertil. Steril., 66, 662-665 46. Sherman JK (1963). Improved methods of preservation of human spermatozoa by freezing and freeze-drying. Fertility & Sterility 14, 49-64. 47. Tomlinson MJ and Pacey AA (2003). Practical aspects of sperm banking for cancer patients. Hum Fertil (Camb).6:100-5. 48. Tomlinson MJ and Sakkas D (2001). Debate Article: Safe and effective cryopreservation: Should sperm banks and fertility centres move toward storage in nitrogen vapour? Human Reproduction 15, 2460-2463. 49. Tomlinson MJ, Kessopoulou E & Barratt CLR (1999). The diagnostic and prognostic value of traditional semen parameters. Review. J Androl 20, 588-93 50. Tomlinson MJ, Moffatt O, Manicardi G, Bizarro D, Afnan M and Sakkas D (2001). Interrelationships between seminal parameters and sperm nuclear DNA damage before and after density gradient centrifugation: Implications for assisted conception. Hum Reprod 10, 2160-2165. 51. Tomlinson MJ, Powell G, Turner J and Sakkas D (2001). One step disposable chambers for sperm concentration and motility assessment: How do they compare with the World Health Organisations recommended methods? Hum Reprod 16, 121-124. 52. TUC guide to health and safety. Hazards at work, The working environment and welfare. 53. World Health Organisation (1997). Guidelines for the safe transport of infectious substances and diagnostic specimens WHO/EMC/97.3 54. World Health Organisation (1999) WHO laboratory Manual for the Examination of Human Semen and Semen-cervical Mucus Interaction, 4 ed. Press syndicate of the University of Cambridge.
th
Glossary of Terms
ACROSOME REACTION: Calcium dependent event and the endpoint of capacitation. Can be induced artificially in sperm function tests using calcium ionophore, progesterone and solubilised zona-pellucida. ACROSOME: Vesicular structure surrounding the anterior part of the sperm head releasing egg-penetrating enzymes after the biding to the zona pellucida in the acrosome reaction. AGGLUTINATION: Adherence of motile sperm to other motile sperm which is often associated with antisperm antibodies. Reduces the observed sperm count and motility. AGGREGATION. Adherence of non-motile sperm to other non-motile sperm, other cells or cell debris. Not to be confused with agglutination. AID: Artificial Insemination by Donor. A procedure where donor sperm is deposited inside the uterus, cervix, or vagina. May be referred to as DI. ALPHA () GLUCOCIDASE: Enzyme measured in order to assess epididymal function. ANDROGEN BINDING PROTEIN (ABP): Protein secreted by sertoli cells which acts as a carrier for androgens including testosterone. ANDROGENS: Male hormones (chiefly testosterone and its derivatives) produced by the Leydig cells of the testes in the male and the ovaries and adrenal glands in the female. ANDROLOGY: The study of man. Usually relates to male reproduction or male specific disorders e.g. prostate cancer, testicular cancer. ANEUPLOIDY: A condition in which cells have excessive or insufficient chromosomal material. Affected sperm, oocytes or embryos may either fail to thrive or give rise to abnormalities in offspring. ANOVULATION: Not producing eggs, or the inability to ovulate. ANTISPERM ANTIBODY: Usually an auto-antibody directed towards a mans own sperm but occaisionally produced by the female to her partners sperm. Men with high levels of usually of the IgG or IgA class often have sperm agglutination, reduced motility or even inability to bind and penetrate an egg. ART: Assisted Reproduction Technology. Procedures to bring about conception without sexual intercourse. ART procedures include IUI, DI, GIFT, ZIFT,ICSI, IVF. ASA: Antisperm antibodies see above. ASPERMIA: Absence of an ejaculate. ASSISTED HATCHING: A micromanipulation procedure that chemically dissolves a small opening in the zona pellucida of the embryo to assist in implantation to the uterine lining. ASTHENOZOOSPERMIA: Poor motility in sperm. World Health Organisation (WHO) definition is defined as <25% rapid motility or <50% progression in a semen sample. AUDIT: the systematic, independent and documented process for obtaining and evaluating evidence and objectively evaluating it to determine the extent to which certain pre-defined criteria are fulfilled. AZOOSPERMIA: Complete absence of sperm, demonstrated by post-centrifugation semen analysis.
BETA hCG TEST: A blood (or urine) test used to detect very early pregnancies and to evaluate embryonic development. A positive test is often referred to as a biochemical pregnancy. BLASTOCYST: An advanced embryo, which when hatched, forms the trophectoderm which eventually forms the placenta and inner cell mass which forms the fetus. BLIGHTED OVUM: A pregnancy in which no fetus has developed in the pregnancy sac. CAPACITATION: A change which sperm undergo in order to have the capacity to fertilize and culminates in the acrosome reaction. Characterised by loss of cholesterol and calcium in the presence of albumin. Capacitation requires sperm to be free from seminal plasma. CASA: Computer Aided Sperm analysis. Principally a research tool using image analysis to track individual sperm and measure their swimming speeds. CASA can also be used to give objective assessment of sperm size and shape. CONTROLLED DOCUMENT: SOPs which has undergone full verification and has been signed off by the head of department. CONTROLLED RATE FREEZER: Equipment used to cool cells or tissues at a chosen rate using nitrogen vapour. Cooling rates can usually be re-programmed to suit a particular cell type e.g. sperm, embryos, testicular and ovarian tissue. CRYOPRESERVATION: A dehydration and freezing process used to preserve embryos, sperm, and other types of tissue. CRYOPROTECTANT: Media added to cells or tissues during cryopreservation which increases survival by reducing ice intracellular and/or solute concentration. CRYPTOZOOSPERMIA: Hidden sperm found in semen samples during analysis only after centrifugation. DENSITY GRADIENT CENTRIFUGATION (DGC): Method used for selecting and preparing sperm by virtue of their density. Sperm with the highest density tend to have improved motility, morphology and DNA integrity. DONOR INSEMINATION (DI or AID): Artificial insemination with donor sperm. DONOR IVF (DIVF): In vitro fertilisation using donor sperm. EJACULATE: The seminal fluid released at orgasm containing secretions from the epididymis, prostate, seminal vesicles and bulbourethral glands. ELECTROEJACULATION: Electrical stimulation to induce ejaculation in a man who may be paralysed below the waist. Usually performed under general anaesthetic. EMBRYO TRANSFER: Placement of an embryo into the uterus of a woman after it has been created in a laboratory. EMBRYO: The early stage of foetal life starting at the fertilised egg or zygote through to blastocyst and eventually the foetus. EOSIN/NIGROSIN TEST: A test of sperm viability which measures the integrity of the sperm membrane and its ability to exclude dye. EPIDIDYMIS: Region of the testes where sperm are stored and mature.
EPIDIDYMITIS: Inflammation of the epididymis. May be a cause of male infertility.

EXTERNAL QUALITY ASSURANCE (EQA): System of objectively checking laboratory results by an external agency. Main of objective is not to bring about day to day consistency but establish between lab comparability. FECUNDABILITY: The ability to become pregnant. FERTILIZATION: The successful union of the sperm and egg. FRUCTOSE: Sugar produced in abundance by the seminal vesicles and sometimes measured to assess the function of the male reproductive tract. FSH: Follicle Stimulating Hormone. The pituitary hormone that stimulates follicle growth in women and sperm production in men. GIFT: Gamete Intra Fallopian Transfer. The combining of eggs and sperm outside of the body for fertilization and their immediate placement into the fallopian tubes to achieve fertilization and pregnancy. GLOBOZOOSPERMIA: Often referred to as round-head defect. Sperm morphological defect where the acrosome is absent and sperm usually have small round heads. GnRH: Gonadotropin Releasing Hormone. The hormone produced and released by the hypothalamus that controls the pituitary gland's production and release of gonadotropins. GONADOTROPINS: Gonadotropins are the follicle stimulating hormones (FSH) and lutenizing hormones (LH). In women, they stimulate the ovaries; in men, they regulate spermatogenesis. HAEMOCYTOMETER: Glass chamber used to assess sperm concentration. HCG: Human Chorionic Gonadotropin. The hormone naturally released in early pregnancy. HCG may be injected to trigger ovulation and progesterone production. It may also be given to some infertile men to stimulate the production of testosterone. HFEA: Human Fertilisation and Embryology Authority. Regulatory body responsible for the accreditation and licensing of infertility treatment centres. HMG: Human Menopausal Gonadotropin. The lutenizing (LH) and follicle-stimulating hormones (FSH) from the urine of post-menopausal women. It is used for superovulation in some fertility treatments. HOS TEST: hypo-osmotic swelling test. A measure of sperm viability which measures the ability of the sperm to regulate water movement across its membrane. HOSTILE MUCUS: Cervical mucus that hinders the natural movement of sperm through the cervical canal. HSG: Hysterosalpingogram. An X-ray examination of the uterus and fallopian tubes using a radio-opaque dye. HYPERSTIMULATION: An adverse reaction to the more powerful fertility medications (usually FSH) caused by excessive stimulation of the ovaries. ICI: Intracervical Insemination. Artificial insemination of sperm into the cervical canal. ICSI: Intracytoplasmic Sperm Injection. Procedure injecting a single sperm into a single egg and used mainly to treat male infertility. IMMUNOBEAD TEST (IBT): Antisperm antibody test using immunobeads coated with antiIgG or anti-IgA.
IMPLANTATION: Implantation of a pre-embryo happens the moment it attaches itself to the uterine wall, resulting in a pregnancy. Implantation may occur between five to ten days after ovulation or embryo transfer (IVF). INFERTILITY: Inability of a couple to achieve a pregnancy or to carry a pregnancy to term after one year of unprotected intercourse. INHIBIN: Hormone produced by sertoli cells lining the testes and is involved in the regulation of spermatogenesis. INVENTORY CONTROL: The system implemented to record the transfer of frozen specimens in and out of storage. INTERNAL QUALITY CONTROL (IQC) procedures undertaken by staff to continuously assess the laboratory work and emergent results to determine whether they are reliable. IUI: Intrauterine Insemination. Artificial insemination of prepared sperm into the uterine cavity. IVF: In Vitro Fertilization. The procedure where eggs are removed from the ovaries and mixed with sperm. Eggs that fertilize become embryos and are transferred to the uterus in the hopes that a pregnancy will result. Spare embryos are often cryopreserved and placed in storage. KALLMANS SYNDROME: A heterogeneous genetic disorder affecting 1 in 10.000 to 60.000 individuals and is characterised by a failure in GnRH secretion secondary to failure of gonadotropin-releasing hormone(GnRH)-producing neurons to migrate from the olfactory placode to the brain. A form of hypogonadotropic hypogonadism. KARTAGENERS SYNDROME: Sometimes referred to as immotile cilia syndrome Genetic defect with an incidence of 1 case per 32,000 live births (USA) in which the problem is with cilial structures e.g. inner and outer dynein arms (most common), radial spokes, central sheaths, nexin links, and ciliary transposition and orientation. Chronic upper and lower respiratory tract disease resulting from ineffective mucociliary clearance are common and immotile spermatozoa result in male sterility. KLINEFELTER'S SYNDROME: A genetic abnormality that may cause infertility. It is characterized by having two X chromosomes and one Y chromosome (XXY). LEUKOCYTOSPERMIA: Defined when the concentration of seminal leukocytes exceeds 6 1x10 /ml. Not thought to be of great clinical significance but may be indicative of infection. LEYDIG CELLS: Androgen (testosterone) producing cells lying outside the seminiferous tubules within the testes. LH SURGE: Lutenizing Hormone Surge. Surge of LH immediately prior to ovulation which. It enables the mature egg to be released from the follicle. LH: Luteinizing Hormone. The hormone that is released by the pituitary prior to ovulation. LIQUEFACTION: Breakdown of the semen coagulum by prostatic secretions, usually within 30 minutes of the sample being produced. LUTEAL PHASE: The portion of a menstrual cycle before menstruation, but after ovulation. A normal luteal phase lasts approximately ten to 16 days. This is the part of the cycle that releases progesterone and enables implantation of the pre-embryo, which may result in pregnancy. MAR TEST: Antisperm antibody test using the Mixed Agglutination Reaction. MEIOSIS: The reduction division process resulting in the number of chromosomes in reproductive cells being reduced from 46 to 23.
MORPHOLOGY: Shape and size of sperm. Samples containing sperm with poor morphology have a reduced chance of achieving a pregnancy. MOTILITY: Refers to the swimming ability of the sperm. World Health Organisation motility grades a,b,c,d refer to rapid progressive, slow progressive, non-progressive and static sperm respectively. NECROSPERMIA: Samples with only dead sperm. NORMOZOOSPERMIA: used to describe a normal semen sample. OLIGOZOOSPERMIA: Used to describe semen samples with a sperm concentration of 6 >20x10 /ml (see severe oligozoospermia). PERCOLL: Colloidal suspension of PVP coated silica used in density gradient centrifugation. PESA: Percutaneous epididymal sperm aspiration.
POLICY: Plan of action adopted. Based on evidence, shrewdness, wisdom etc.

POST-COITAL TEST: Test timed to ovulation where cervical mucus is harvested usually 8-12 hours after coitus and examined for the presence of motile sperm. Tests whether a mans sperm will penetrate the cervical mucus of his partner and whether the female partner is producing suitable mucus at the time of ovulation. PROCESS: Path or system linking procedures together. For example the IVF process is constituted of consultation, clinical and laboratory procedures. PROGESTERONE: The hormone produced during the second half (luteal phase) of a woman's cycle. It helps to thicken the lining of the uterus in preparation for implantation of a fertilized egg. PROTOCOL: Set of instructions relating to a procedure.These could be numbered instructions in a methodology and there may be several protocols for a procedure . QUALITY ASSURANCE (QA): Part of quality management focused on providing confidence that quality requirements will be fulfilled. QUALITY CONTROL (QC): How the service fulfils quality requirements - relates to gathering and analysing process data to determine whether the process exhibits non-random (systematic) variation. QUALITY: Meeting or exceeding service user expectations. Service meets a stated (or implied) need, conforms to requirement, is fit for purpose. RETROGRADE EJACULATION: Semen that flows backwards into the bladder instead of forward through the urethra. It is caused by damage to the nerves closing the bladder neck and is often associated with conditions such as diabetes and spinal injuries. ROS: Reactive Oxygen Species or free oxygen radicals, which can damage sperm membranes by a process of lipid peroxidation or induce DNA damage. SCROTUM: Sac of skin and thin muscle that holds the testicles. SECONDARY INFERTILITY: Infertility of six months or more in a couple that has previously had a child. SEMEN ANALYSIS: Examination of semen for quality. The World Health Organisation (1999) provide guidelines for best practice and this includes the routine measurement of sperm concentration, motility, morphology and vitality. Optional tests include antisperm antibodies.
SEMINAL VESICLES: The two glands found below the bladder which produces seminal fluid. SEMINIFEROUS TUBULES: The tubes found in the testicles that produce sperm. Sertoli cells line the tubules and provide support for the developing sperm. SERTOLI CELL: The cells found in the testes that support developing sperm and importantly secrete androgen binding protein and inhibin. SEVERE OLIGOZOOSPERMIA: Used to describe semen samples with a sperm 6 concentration of <5x10 /ml (see oligozoospermia). SOP (STANDARD OPERATING PROCEDURE): Controlled document which describes a defined way of progressing a course of action or policy. Usually incorporates a protocol, narrative, cross references, risk and COSHH assessments etc. SPERM BANK: A place where sperm is collected and frozen to be used at a later time or donated for use in Assisted Reproductive Technologies (ARTs). SPERM CONCENTRATION: Often referred to as sperm count or density and is the number of sperm per millilitre of semen. SPERM MIGRATION TEST (SMT): Diagnostic sperm preparation using a swim-up (see below). Concentration of motile sperm harvested is used as a threshold for deciding treatment using ART. SPERM WASHING: Technique used to separate the seminal fluid from the sperm. Involves the addition of culture media (sperm buffer) and centrifugation. SPERM: The male reproductive cell or gamete. SPERMATIDS: 1 Round and then Elongate spermatids undergo a prolonged phase of differentiation (spermiogenesis). SPERMATOCYTE: An immature sperm cell. Diploid primary spermatocytes (2N) undergo the 1st meiotic division (M1) to form diploid secondary spermatocytes (2N). Secondary spermatocytes (2N) divide meiotically (M2) to form haploid round spermatids (N). SPERMATOGENESIS: Production of sperm within the seminiferous tubules. SPERMATOGONIA - Diploid cells (2N) which line the seminferous tubules and are the earliset stage of sperm development. They divide mitotically after puberty. Type A self replicate or differentiate to type B. Type B divide to form primary spermatocytes which migrate through Sertoli cell tight junctions. SPERMATOZOA: The male reproductive cell or gamete. Also called sperm. SPERMIOGENESIS: End point of spermatogenesis in which round spermatids differentiate into elongate spermatids and eventually spermatozoa. SPINNBARKEIT: Used in a Post-Coital Test to test the stretchability of cervical mucus. SPLIT EJACULATE: The method of collecting a semen specimen so that the first half of the ejaculate (sperm rich fraction) is caught in one container and the rest in a second container. SUPEROVULATION: Ovulation induction usually using the gonadotrophin FSH, usually as part of an IVF, ICSI or IUI treatment cycle. SURGICAL SPERM RETRIEVAL (SSR): therapeutic sperm retrieval for use in ART procedures. Usually a PESA, TESA or TESE.
ST
SWIM-UP: Method for preparing sperm by virtue of their motility. Culture media (sperm buffer) is layered over semen or sperm pellet for sperm to swim into. Often used diagnostically and referred to as the Sperm Migration Test (SMT). TESA: Testicular sperm aspiration. TESE: Testicular sperm extraction. TESTICULAR BIOPSY: The surgical removal of testicular tissue to determine if the cells have the ability to produce normal sperm or to diagnose possible neoplasms. TESTICULAR FAILURE: Indicated by raised FSH and azoospermia. TESTICULAR TORSION: A disorder where the testicle twists on itself, cutting off its own blood supply. TESTOSTERONE: Major male hormone produced by the Leydig cells of the testes, involved in the development of secondary sex characteristics and the production of sperm. TETERATOZOOSPERMIA: Used to describe a semen sample with a high percentage of abnormally shaped or sized sperm. TOTAL QUALITY MANAGEMENT (TQM): Management philosophy based on setting objectives and implementing policies and procedures which will achieve those objectives with an overall emphasis on quality. TRANSVAGINAL ULTRASOUND ASPIRATION: The technique used in in vitro fertilization to retrieve or aspirate the eggs. UKNEQAS: UK National External Quality Assurance Scheme for semen analysis.
UNCONTROLLED DOCUMENTS: SOPs still at the editing and verification stage.

USERS: Patients using a diagnostic or patients to that service. treatment service or those clinicians referring
VAS DEFERENS: The tubes that connect the epididymis, where the sperm is stored, to the urethra. Contractions of the vas occur during ejaculation. VASECTOMY: Male surgical sterilization by tying the vas deferens. VASOVASOSTOMY: Vasectomy reversal operation or re-joining of the vas-deferens. VISCOSITY: Semen sample which forms long strands instead of droplets. Can make dilution, analysis and preparation difficult. WITNESSING: The process of verification of a patients identifiers by a second staff member, usually prior to transfer of patient material from one vessel to another. ZIFT: Zygote Intra Fallopian Transfer. A form of in vitro fertilization where the fertilized egg is placed into the fallopian tube. ZONA PELLUCIDA: The glycoprotein coating surrounding the egg. Sperm binding to this area induces the acrosome reaction. ZYGOTE: A fertilized egg.
Appendices
1 Example of a Laboratory Policy
The laboratorys commitment to providing and maintaining a high quality diagnostic and treatment laboratory service. This commitment is demonstrated by: Providing appropriate numbers of staff for each laboratory activity. The implementation of appropriate personnel procedures in order to ensure that staff are carefully selected and trained to high standards. The implementation of appropriate personnel procedures in order to ensure that staff engage in continuing professional development activities which are relevant to their specific role within the laboratory. Providing high standards with regard to laboratory facilities and equipment and that these are regularly maintained and inspected. The implementation of standard operating procedures, which take into account recent developments from regulatory bodies, in laboratory medicine, assisted conception and cryogenics as appropriate. The implementation of standard operating procedures, which describe the best available validated methodologies. The implementation of an appropriate risk management policy in order to maintain high standards and minimise risk to the health and welfare of staff and service users. Implementation of quality assurance procedures which include participation in appropriate EQA (external quality assurance) schemes. A commitment to responding to the needs of our service users, including patients and referring clinicians e.g. Consultants in Ob/Gyn, Oncology, General Practitioners A commitment to reviewing all of the above on a regular basis.
Subheadings for SOPs Unique identification code, issue no., no. of pages and copy number Location within the Department Authorisation and Date of issue History and circulation lists Table of contents Purpose and scope Staff Grade/Qualifications Introduction, methods and instruction Equipment and Consumables Required References, cross references Staff signature
SOPs should follow a set format and include the following information:
SOP management
An SOP for writing SOPs should also describe how SOPs are managed including: Writers and editors Usually the most senior member of a particular discipline leads in document preparation and editing, is assisted by his or her team. Uncontrolled and Controlled Documents Uncontrolled documents are SOPs at the editing and verification stage. Controlled Documents has undergone full verification, in that all copies are: Marked with an edition number; printed on paper of a distinct colour; authorised by the Responsibility and Authorisation Head of Department and Signed by the relevant members of the team - The head of department is usually responsible for authorising the quality manual and the management procedures. Senior section heads are able to authorise those procedures pertaining to their own departments, providing that person has not been the sole author of the document. Copies - each SOP will have at least 2 authorised copies, one for the document library and one in the relevant work area. The number of copies will depend on the content and to how many sections it has relevance for. For example management documents will be kept in a number of sections from the clinic through to laboratories and the R&D office. Issue - the relevant section head is responsible for ensuring that all staff are briefed and trained in either new or revised SOPs. Relevant members of staff must read and understand the SOP or changes and sign and date the staff signature list to verify this. Document Removal - any redundant documents are removed from circulation and replaced with revised ones by the authorising signatory. Copies of redundant documents are kept as a record in the document archive and their date of withdrawal noted in a master document index. Document Amendment - any amendment that does not materially affect a procedures operation e.g. typographical errors, change of supplier can be made but any minor amendment should be recorded as a procedure amendment. Documentation Audit - Audit of all documentation should be designed to check that: documents are signed and authorised; documents are valid and contain no major hand written changes; documents are located in the correct areas
Guidelines for the retention of specimens and records of specimens
Permanent storage is without limit but refers to no longer than 30 years. In general stored records and specimens should be appropriately organised and so that retrieval is straightforward. a. Stained slides (e.g. sperm morphology) should be kept for 1 year after the final checked report has been despatched. b. Samples should be kept until a report is issued. c. Request forms should be kept for at least as long as it takes for the user to receive the authorised report. Ordinarily this period does not need to be longer than 1 month after the final checked report has been sent. Where the request contains clinical information not readily accessible in the patients notes, it should be kept permanently. d. Log books (Day books) and other specimen records: at least 2 calendar years. e. Protocols (of Standard Operating Procedures): Current and outdated protocols should be dated and kept permanently on file. f. Worksheets: Should be kept for the same length of time as the related permanent (or semi permanent) specimens or preparations. g. Records of telephoned reports: should be logged on the patients file or other working records. h. Report copies: at least 6 months for operational purposes. i. j. k. l. Treatment related reports for 30 years. Internal Quality Control records: Permanently. External Quality Assurance records: 2 calendar years for subscribing laboratories. Accreditation documentation/Records of inspection: Ten years or until superseded. m. Equipment maintenance logs Lifetime of the instrument (minimum of 10 years).
Management Review Subheadings
a. Laboratory resources: Changes in personnel Staff levels Staff satisfaction Training Equipment Finance
b. Overall review of performance indicators (for detail see H 1.1): c. Overall review of user satisfaction and complaints: User surveys (Ob/Gyn and Oncology Consultant/GP and patients) Staff Survey
d. Internal Audit: - Internal audit of semen analysis and sperm storage processes - Storage inventory audit (frozen stored material) - Equipment audit (maintenance, performance, data logging) e. External quality assessment f. Reports on any EQA schemes Reports of assessments by outside bodies (if applicable): Human Fertilisation and Embryology authority (HFEA) Commission for Health Improvement (CHI) Clinical Pathology Accreditation UK (CPA UK LTD) Other e.g. Medicines and Healthcare products Regulatory Agency (MHRA), Health and Safety Executive (HSE)
Finance Report: - Business plan review - Performance against contracts
g. HFEA compliance issues - Legal disputes
Examples of vertical audits in andrology
DIAGNOSTIC SEMEN ANALYSIS B VERTICAL AUDIT REPORT

Signature:
A6.1.1.1.1.1
D Name of assessor: a t e YES
Accession (SFA No.)
NO
Deficiencies
Does the entry in the andrology logbook show the patients full name, date of birth, unit no., testing procedure?
Is there a corresponding request form for the above test? Do the demographic details on that request match the above? Do the demographic details on the report form match those on the request? Do the details on the report form correspond to those in the logbook? Has the testing procedure been carried out in accordance with the request? Have the demographic details been entered correctly on the computer? Have the sample test details been entered correctly on the computer? Does the overall diagnosis/comment correspond to the test details? Has the typed report been generated and filed in the patient notes?
Corrective action to be taken:
C SPERM STORAGE PROCESS

A6.1.1.1.1.2 D Name of assessor: a t e
VERTICAL AUDIT REPORT
Signature:
Storage No. Does the entry in the storage patient register show the patients full name, date of birth, reason for storage and referring centre? Is there a corresponding entry in the andrology logbook showing the accession (SFA No.) and testing procedure? Is there a corresponding set of notes in the andrology office? In the set of notes is there: A request form from the referring centre? A signed in-date consent form 96/00(6) or 00(9)? A laboratory report form showing the results of the storage procedure? A completed ACU/BWH contract?
YES
NO
Deficiencies
Do the demographic and sample details on that report correspond with those : On the request form? In the storage patient register and andrology logbooks? Has the testing procedure been carried out in accordance with the request? Comments and Corrective Action
YES Is the location of the stored material clear from the patient notes? Does the storage location in the notes correspond with that of the T card? Do the sample details written on the T card correspond to those in the patient notes? Is the T card in the correct location and does it correspond to the correct freezer location Is there a corresponding patient record on the MSAccess storage database? Are the following computer details correct? Demographic details including referring centre? Sample quality and no.s of vials/straws stored? Storage location(s)? Date of consent? Has the referring Dr been notified of the outcome of the storage? Comments and Corrective Action
NO
Deficiencies
E DONOR SPERM STORAGE PROCESS

F
A6.1.1.1.1.3
VERTICAL AUDIT REPORT

Signature:
D Name of assessor: a t e YES
DI cycle No: Donor Used:
NO
Deficiencies
Does the entry in the DI red book show the Donor code, patients, date of birth, date of treatment and treatment details?
Is there a corresponding entry for this DI cycle in the embryology lab book/folder?
Are there clear records in the cryoroom showing: The date this donor was used? The date it was allocated to this recipient? The date the sample was obtained from the supplying centre? The date the donor was frozen and stored? If the donor is a BWH donor, the date of release, freeze date and consent? Has the treatment record been entered on the DI treats.xls spreadsheet? If the treatment cycle resulted in pregnancy Is there a corresponding HFEA pink DI treatment form ? If applicable is there a blue outcome form? Has DI treats.xls been updated?
Comments and Corrective Action

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Guidelines for Good Practice

ABA guidelines for good practice 1 edition 3/04

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Organisation and Quality Management

Total Quality Management (TQM)

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Regulation in Laboratory Andrology

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Premises and Environment

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Equipment, information systems and reagents

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Pre- Examination Processes

Information for Service Users

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g. There should be suitable decontamination procedures between patients.

h. Sperm preparation for treatment must involve verification or witnessing of patient

g. Sperm must be frozen in suitable containment or plastics and according to

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Risk Management Procedures

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The post examination phase

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a. Clinical interpretation should be carried out by an appropriately trained scientist with

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Evaluation and Quality Assurance

The results of audits should be discussed within the management review.

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Assessment of user satisfaction and complaints

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External Quality Assurance (EQA) Schemes

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