Participants’ Manual UK NEQAS for Feto-Maternal Haemorrhage Version 5 December 2013 Contents FREQUENTLY ASKED QUESTIONS 1 ORGANISATION OF THE SCHEME 2 Location 2 Key Scheme Personnel 2 Oversight of EQA 2-3 Confidentiality 3 Accreditation 3 Data Security 3 Helpline 4 Complaints and appeals 4 AIMS OF AND PARTICIPATION IN THE SCHEME 4 SCOPE AND FREQUENCY OF TESTS OFFERED 5 COST OF PARTICIPATION 5 SURVEY FORMAT 5 PARTICIPANT REFERENCE NUMBER (PRN) 6 COMPLETING THE REGISTRATION FORM 6 SOURCE AND MANIPLUATION OF SURVEY MATERIALS 7 DESPATCH OF SURVEY MATERIALS 7 UNDERTAKING THE SURVEY 8 QUESTIONNAIRES 8 LATE RESULTS 9 ASSIGNED VALUES 9 PENALTY SCORING SYSTEM 9-10 PERFORMANCE MONITORING 10-11 REPORTS 11 RELATED SCHEMES 12-13 APPENDIX 1 - INSTRUCTIONS FOR WEB RETURN OF RESULTS 14-18 APPENDIX 2 - EXAMPLE OF RESULT SHEET (Acid Elution Quantification) 19 APPENDIX 3 - EXAMPLE OF RESULT SHEET (Flow Cytometry Quantification) 20 APPENDIX 4 - EXAMPLE OF RESULT SHEET (Acid Elution Screen only) 21 APPENDIX 5 - EXAMPLES OF REPORT (Acid Elution Quantification) 22-23 APPENDIX 6 - EXAMPLES OF REPORT (Flow Cytometry Quantification) 24-25 APPENDIX 5 - EXAMPLES OF REPORT (Acid Elution Screen only) 26-27 UK NEQAS (FMH) Participants’ Manual FREQUENTLY ASKED QUESTIONS Q: How do I know when to expect the survey material? A: An annual schedule is sent at registration or re-registration. A schedule can also be found on the website: http://www.ukneqasfmh.org Q: What do I do if my specimens don’t arrive when expected? A: If they haven’t arrived by three days after the published distribution date, you should phone the Scheme for advice on +44 (0) 1923 217878. Q: Why is there only a one week closing date? A: Neither the adult red cells nor the cord cells are stable enough to allow us to extend the closing date further. The adult cells become crenated and make interpreting the film more difficult and the cord cells appear to become fragile and may be selectively destroyed by the preparation process for testing by flow cytometry. The steering Committee feels that it is entirely appropriate that the EQA samples are dealt within the usual turnaround times for clinical samples. Q: What do I do if I miss the closing date? A: Results can still be analysed until the reports have been published. However, late results do attract 50 penalty points and the films must have been made, and/or the flow cytometry testing undertaken, on or before the closing date, as the Scheme cannot guarantee the integrity of the samples after the closing date. If in doubt, you should contact the Scheme for advice. Q: What do I do if the sample quality is unsatisfactory or if I break the samples? A: Phone the Scheme on +44 (0) 1923 217878 to request a repeat sample. You will be asked for your PRN and the reason for your request. Q: How do I register for web entry? A: Send an email request to the scheme at [email protected]. Valid email addresses will also be required for the consultant contacts and any other contact who requires a report. Q: What do I do if I cannot find or have forgotten my ID or password? A: Email the Scheme at [email protected] or phone +44 (0)1923 217878. If you are not the main contact, your email request will need to be copied to the main contact, in order for us to release an ID or password. Q: Can I change my password details? A: You are supplied with a randomly generated password. Although you may change this on request, there are some restrictions, e.g. the password must be at least 7 characters long and contain a mixture of alpha and numeric characters. Q: Can I register for acid elution and flow cytometry A: Yes you can. You will be given a second registration number (usually the same as your original number but with a letter as a suffix, e.g. 12345A) for the second method. If you screen by acid elution and quantify by flow cytometry, you will also need two registrations, which will need to be managed separately by the laboratory to avoid the flow cytometry results inadvertently influencing the screening results. Page 1 of 27 FMH Particpants’ Manual CD F30 V5 December 2013 UK NEQAS (FMH) Participants’ Manual ORGANISATION OF THE SCHEME Location The Scheme is hosted by the West Hertfordshire Hospitals NHS Trust and is based at Watford General Hospital, in a Unit shared with UK NEQAS (H) and (BTLP). Postal address: PO Box 1000, Watford, WD18 0RJ Telephone: +44 (0) 1923 217878 Fax: +44 (0) 1923 217934 Email: [email protected] Key Scheme Personnel The Scheme is jointly managed by UK NEQAS (BTLP) and UK NEQAS (H). All staff have shared posts: Co-Directors: Professor Keith Hyde and Dr Megan Rowley Co-Managers: Mrs Clare Milkins and Mrs Barbara De la Salle Deputy Managers: Ms Jenny White, Mr Paul McTaggart EQA scientists: Ms Nikki Emodi, Mr Arnold Mavurayi Executive Assistant: Ms Isabella De-Rosa Operations Supervisor: Mr Steve Herbert Office Manager (job-share): Ms Jen Rigg/Vacancy Oversight of EQA There is an advisory and regulatory framework that governs EQA schemes in the UK. Steering Committee and Specialist Advisory Group The UK NEQAS Steering Committee for Blood Transfusion Laboratory Practice (BTLP) advises and supports the Scheme Directors on the scientific content of the Scheme; the Steering Committee is supported in this task by the Specialist Advisory Group (SAG) for FMH. The Committee and SAG both comprise scientific and clinical members, and the SAG includes experts in both acid elution and flow cytometry techniques. Membership of the Steering Committee and SAG is ratified by and accountable to the UK NEQAS Executive Committee. The Chairman of the Steering Committee is Dr Peter Baker, Transfusion Department, Royal Liverpool University Hospital, Liverpool, L7 8XP National Quality Assurance Advisory Panel (NQAAP) and Joint Working Group (JWG) NQAAPs are professional groups which are responsible to the pathology professions and the Health Departments for monitoring the maintenance of satisfactory standards of laboratory performance in the United Kingdom, whether in the private or public sector. Their members are nominated by the Royal College of Pathologists, the Association of Clinical Pathologists and the Institute of Biomedical Science, as well as by specialist professional bodies. The Panels are discipline specific and the Chair of each Panel reports to the Joint Working Group (JWG) on Quality Assurance. UK NEQAS (FMH) makes an annual report on scheme activities and performance of UK laboratories to the Panel for Haematology, and makes quarterly reports of Persistent Unsatisfactory Performance to the Chair of the Panel, using defined criteria which have been approved by the Panel. The Joint Working Group (JWG) for Quality Assurance is a multidisciplinary group accountable to the Royal College of Pathologists for the oversight of performance in external quality assessment schemes Page 2 of 27 FMH Particpants’ Manual CD F30 V5 December 2013 UK NEQAS (FMH) Participants’ Manual (EQA) in the UK. Membership consists of the Chairmen of the NQAAPs, and representatives from the Institute of Biomedical Sciences, the Independent Healthcare Sector, the Department of Health and UKAS. The JWG has defined Conditions of EQA Scheme Participation, which can be found on the RCPath website*. By signing the registration form, new UK participants agree to abide by these conditions, and existing participants indicate their continued acceptance of the Conditions at reregistration. *http://www.rcpath.org/committees/intercollegiate-and-joint-committees/joint-working-group-forquality-assessment-in-pathology – ‘Conditions of EQA Scheme Participation’ accessed as a pdf from this page. Confidentiality Details of performance in the Scheme are confidential between the participating laboratory and the Scheme Director (and designated senior UK NEQAS staff). However persistent unsatisfactory performance is reported to the NQAAP, and the identity of the laboratory may be revealed to the Panel, through secure means. The fact and level of participation may be disclosed to management within the participant’s institution. Accreditation The Scheme has held accreditation with CPA (UK) Ltd since 1999 and is working towards ISO Standards:17043:2010, Conformity assessment – General requirements for proficiency testing, with inspection due in 2014. Data Security The Data Protection Act (1988) prevents the misuse of personal data held electronically and ensures that organisations holding such data conform to certain standards. The West Hertfordshire Hospitals NHS trust is registered as a ‘data user’ under the terms of the Act. Information provided by participants in the registration forms is held in a database in order to identify those participants registered for a given activity and to generate address labels for the despatch of material, reports or letters. In addition, the results from surveys are held (as non-personal data) in a database for analysis. The scheme uses participants’ e-mail addresses to inform them of survey distribution and report availability; in addition they are used to inform participants of meetings and other activities, and to invite participation in on-line surveys specifically relevant to the scheme. They may also be used to contact or survey participants on wider aspects of anti-D prophylaxis and FMH; however, during the registration or re-registration process, the terms and conditions for participation allow participants to opt-out of the use of e-mail addresses for this purpose. Page 3 of 27 FMH Particpants’ Manual CD F30 V5 December 2013 UK NEQAS (FMH) Participants’ Manual Helpline Advice on any aspect of the scheme or other related matters on performance may be sought from the Scheme Managers or senior scientific staff by telephone or in writing. Problems or enquiries relating to a specific survey or survey material may be directed to one of the senior scientific staff. Invoicing or registration enquiries may be directed to a member of the administration team. Names and contact numbers can be found on page 2. Complaints and appeals The Scheme has a written complaints procedure. In the first instance, complaints regarding the service provided by the Scheme should be directed in writing to the Scheme Director or the Scheme Manager as appropriate to the nature of the complaint. All written complaints will receive an acknowledgement within one week of receipt and a written response within four weeks of receipt. Any unresolved complaints can be directed to the Chair of the Steering Committee, the Chair of the National Quality Assurance Advisory Panel (Haematology) or the Joint Working Group. Appeals relating to performance issues should be made in the first instance to the Scheme Managers or Directors. In the event of an unsatisfactory response, the appeal should be escalated to the Chair of the Steering Committee or the Chair of the National Quality Assurance Advisory Panel. AIMS OF AND PARTICIPATION IN THE SCHEME The aims of all UK NEQAS Schemes are primarily educational. Provision of identical samples to all participating laboratories allows inter laboratory comparability and also identifies the overall level of performance within the UK. Corrective action taken as a result of unsatisfactory performance can lead to an improvement in proficiency within an individual laboratory. Learning from others through reports of surveys leads to an improvement within the UK as a whole. By linking results with techniques and procedures, specific strengths and weaknesses can be identified, driving change. National guidelines are reinforced and the need for new guidelines identified. EQA forms an essential part of quality assurance within a laboratory and provides evidence of individual laboratory performance. However, it gives only a snapshot of a laboratory’s performance at any given time and the information reported back is inevitably a retrospective view of the quality of results. It should be undertaken in addition to, not in place of, other quality assurance measures. Participation in an appropriate, accredited EQA Scheme is a requirement of accreditation to CPA (UK) Ltd and ISO1589 standards. Page 4 of 27 FMH Particpants’ Manual CD F30 V5 December 2013 UK NEQAS (FMH) Participants’ Manual SCOPE AND FREQUENCY OF TESTS OFFERED Tests Screening for FMH by acid elution (fetal cells seen and quantification triggered) Quantification of FMH in mL a) by acid elution b) by flow cytometry Additional Information collected for performance monitoring for laboratories registered for acid elution Initial dose of anti-D suggested Referral for flow cytometry The additional information is used to determine whether the participant would place a woman at risk of sensitisation to the D antigen in a similar clinical situation. The Scheme distributes 12 samples per year, currently two samples six times per year. Participants receive a schedule of the survey despatch dates at registration or annual reregistration. The schedule is also published on the website. Any changes to the schedule are highlighted on the website and participants informed by email. COST OF PARTICIPATION A fee sheet is sent to prospective participants on enquiry, and to existing participants at reregistration time. Early in the calendar year, participants receive details of how to re-register online. Re-registration requires an official purchase order number to cover membership for the following fiscal year (April to March), against which an invoice will be raised and issued during the first quarter of the new fiscal year. Different arrangements are in place for participants from outside of the UK, and are detailed in the registration or re-registration documentation; costs are likely to include courier service to ensure prompt delivery. Individual quotes are given on request. Payment may be made directly to the Scheme or through an agent. EQA services are subject to VAT at the standard rate. This does not apply to NHS establishments within England, since the Scheme is hosted by an English NHS Trust. Details of how payment may be made are included on the invoice. Non-payment within the period stated on the invoice may result in suspension from the Scheme. Re-instatement will incur an additional administrative fee of £50.00. SURVEY FORMAT Each survey includes two whole blood samples coded to denote the year, survey and ‘patient’ identity. Other forms of material, e.g. unfixed films, may be distributed on a trial basis during the year. Page 5 of 27 FMH Particpants’ Manual CD F30 V5 December 2013 UK NEQAS (FMH) Participants’ Manual PARTICIPANT REFERENCE NUMBER (PRN) At registration, each participant is assigned a PRN that is used on performance reports and for internal data handling, in order to preserve confidentiality. This number is unique to a participating organisation; however, the same number may be assigned to several departments or sub-departments within the same organisation. Currently, participation in UK NEQAS (BTLP), (H), and (FMH) by a single organisation, results in a single PRN, whilst performance data remains confidential within each scheme. Where more than one method is registered (acid elution and flow cytometry), the second method will be uniquely identified by the addition of a suffix to the main PRN, e.g. PRNs 12345 and 12345A. The option of having one PRN for participation in all UK NEQAS Schemes is now available if required. Please contact the Scheme Managers for details. It is essential that the PRN be correctly quoted with all communications, including telephone enquiries. COMPLETING THE REGISTRATION FORM Master address details: New participants are required to provide addresses (postal and email) and contact numbers for the following: the consultant clinically responsible for FMH; the technologist/scientist to whom the survey material will be directly addressed; Return of results is via web-entry and accurate e-mail addresses are essential for all contacts. Additional contacts can be registered for notification that the survey is open on the web, or that the reports are ready to be downloaded from the web. Letters concerning unsatisfactory performance are addressed to the consultant and copied to the main technologist/scientist contact. Participation details: This section requires participants to register for all sections covering the work routinely undertaken (by ticking the appropriate boxes) in their laboratory as follows: Screen only Quantification only Screen and quantification (this will be the most common option registered). Method and Techniques: Participants should register for the technique(s) in use in their laboratory for quantification of FMH: acid elution, flow cytometry or both. Standard Dose: Participants should register the standard post-natal dose of anti-D given in their institution. This may not be applicable in reference laboratories. Finance details: Participants are requested to provide details of the invoice address along with a purchase order number. Within the UK, invoices cannot be raised without an order number. It is important to indicate the type of laboratory, since this may impact on VAT or postal requirements, and may also used for performance analysis and monitoring. Page 6 of 27 FMH Particpants’ Manual CD F30 V5 December 2013 UK NEQAS (FMH) Participants’ Manual Terms and conditions By signing the registration form, new participants agree to abide by the UK NEQAS Terms and Conditions, which in the case of UK laboratories, includes the JWG Conditions of EQA Scheme Participation (see page 3 for details). Existing participants indicate their continued acceptance of the Terms and Conditions at re-registration. SOURCE AND MANIPULATION OF SURVEY MATERIALS The survey material is prepared using adult blood obtained from the NHS Blood and Transplant (NHSBT) and cord blood from the NHSBT Cord Bank. All materials are tested at source for HBsAg, HIV 1, HIV 2, HCV and HTLV antibodies, and found to be negative. However, such testing does not ensure that exercise materials are free from infectious agents and a Control of Substances Hazardous to Health (COSHH) information sheet is included with each exercise. The containers and contents must be handled and discarded in line with laboratory policy for clinical material. D positive cord cells are mixed with one or more donations from group AB D negative (or ABO matched), adult donors (tested for abnormal haemoglobins) in calculated proportions for each sample. Broad spectrum antibiotics are added to ensure sterility. The material is dispensed using a validated technique to ensure consistency throughout the dispensing process. DESPATCH OF SURVEY MATERIAL Survey materials are despatched within the UK by first class mail, addressed to the main laboratory contact as defined in the registration form. Different arrangements are in place for participants outside of the UK, and vary from country to country. All packaging complies with current IATA regulations. The nature of the contents of the package (‘Exempt human specimens’), the temperature of storage on receipt, and the address of the sender are indicated on the package. UNDERTAKING THE SURVEY General considerations In keeping with the JWG Conditions of Participation, the EQA samples should be handled, as far as possible, in the same way as routine clinical samples, so that the survey is representative of routine laboratory performance, as highlighted in the following examples: The most expert member of staff should not always perform the survey, unless there are no other staff members are available. There should be no collaboration between different staff members unless the results indicate that this would be the case with a similar clinical sample (this may indeed be the case with a positive acid elution test). The same specimen should not be tested multiple times unless the results indicate that this would be the case with a similar clinical specimen. There should be no collusion with other institutions. Spare material may be used to test additional techniques or staff members, but only after the results have been submitted. Some spare material should also be kept until the report is Page 7 of 27 FMH Particpants’ Manual CD F30 V5 December 2013 UK NEQAS (FMH) Participants’ Manual received in case repeat testing is necessary. It is also advisable to keep the blood films until after the closing date, for in-house re-assessment or submission to the Scheme if required. Survey Paperwork The samples for each distribution are accompanied by Control of Substances Hazardous to Health (COSHH) instructions, general information and survey specific instructions; result sheets are provided for the small minority not registered for web-entry. Completion and Submission of Result Sheets Web-entry On registration for web-entry, an ID code and password are supplied by e-mail, with a link to instructions for completion of the web-forms. Hard copy result sheets are not supplied, although a pdf template is downloadable from the website, for internal use only. Results can be partially entered and saved at any time before the closing date. Once the ‘complete’ button is selected, the results are submitted to the web-server and cannot be edited by the participant. Faxed or posted copies of results will only be accepted in exceptional circumstances, and must be discussed first with a senior member of the Scheme staff. All web results are collected automatically as part of the closing of data entry on the web, including those ‘saved’ but not ‘submitted’. These will automatically be submitted by the Scheme on the participants’ behalf. Web data entry instructions can be found in Appendix 1. Paper results The minority of participants not registered for web-entry are required to document their results on the sheets provided. These may be returned by fax or post, but must be received by the closing date. Results The stated method details should be checked to ensure that they are correct, and these should be updated if necessary. Actual Bleed Volume results are to be recorded as mL packed cells to one decimal place, and the Reported FMH Result as a whole number. Percentage fetal cells should be recorded if calculated routinely. The calculated and prescribed anti-D doses should be given in international units (IU). Follow-up procedures should be completed as if the EQA sample were a post delivery clinical sample. Examples of the result sheet can be found in Appendices 2, 3 and 4. QUESTIONNAIRES Questionnaires regarding FMH related procedures may be issued periodically. It is extremely important that these are completed and returned so that significant associations between performance and procedures can be established and the analysis returned to participants. Page 8 of 27 FMH Particpants’ Manual CD F30 V5 December 2013 UK NEQAS (FMH) Participants’ Manual LATE RESULTS The Scheme tests the survey material on the closing date to provide evidence that it has remained stable throughout the course of the distribution. Therefore, the films for acid elution must have been made, and flow cytometry testing must have been undertaken, on or before the closing date for late results to be accepted. Late results are analysed shortly after reports have been posted to the web but incur a late penalty (see next section). Results received after the results have been posted to the website will not be analysed. Participants are advised to contact the Scheme if they are planning to submit late results. Participants first receive a ‘non-return’ report, which includes the overall data, and any additional attachments, e.g. supplementary reports. This is followed by a replacement report, which includes the individual participant’s data analysed against, but not included in the overall data. ASSIGNED VALUES Target bleed volume ranges are planned for the year and samples are made by adding the calculated volume of cord cells to adult cells, taking the PCV of each into account. However, there are other variables in both the adult and cord cells, and there is no means of validating the absolute value of the simulated FMH. The method median is therefore used to calculate the penalty scores as described in the next section. In-house testing is undertaken on the day of distribution, and again on the closing date on samples which have been subjected to the postal system. Red cell morphology and staining are assessed by acid elution, and stability is assessed by flow cytometry. In addition, the acid elution median results are plotted by date tested to give an additional assurance of stability. Samples which have not remained stable are withdrawn from scoring. Flow cytometry is the accepted reference method, and the flow cytometry median is used as the assigned value for calculating the amount of anti-D required when identifying acid elution users making ‘clinical significance errors’ (see next section on performance monitoring). PENALTY SCORING SYSTEM Analytical Performance Score The median for each method, and the SD derived from the method inter-quartile range, are used to produce a Deviation Index (DI). The DI from the results of the six most recent specimens for which results have been returned is used to calculate the Analytical Performance Score. Scoring is not applicable for acid elution where the bleed is <4mL (based on the flow cytometry median), and is not applicable for either method where the bleed is 0mL. There are three steps involved in the calculation of the score: 1. The method DI is calculated using the formula DI= (R-M) SD Where: R=Laboratory Result M=Method Median SD=Standard Deviation 2. The absolute value of the Method DI is taken (ignoring the sign) and any DI values greater than 3.5 are rounded down to 3.5, to avoid very high values having an excessive effect on the calculation. Page 9 of 27 FMH Particpants’ Manual CD F30 V5 December 2013 UK NEQAS (FMH) Participants’ Manual 3. The resulting DI values for the six most recent specimens for which results have been returned are added together and then multiplied by a constant to give the Analytical Performance Score. The constant is currently set at 8 for acid elution and 7 for flow cytometry. Examples are given in tables 1 and 2 below for two laboratories at the end of 1304F: Table 1: The following DIs were obtained for a participant using acid elution (AE) Survey Patient 1 Patient 2 1301F -0.71 +1.65 1302F +0.05 -1.31 1303F +1.92 Not scored for AE 1304F Not scored +2.10 Score = (2.1+1.92+1.31+0.05+1.65+0.71) x8 = 61.9 Table 2: The following DIs were obtained for a participant using Flow Cytometry (FC) Survey Patient 1 Patient 2 1301F Not included in most +2.7 recent 6 1302F +4.87 +4.87 1303F +5.17 Not scored 1304F -2.97 +3.07 Score = (3.07+2.97+3.5+3.5+3.5+2.7) x7 = 134.7 PERFORMANCE MONITORING Participants’ performance is monitored in four areas: 1. The numerical score for accuracy of quantification, described in the previous section. 2. Grossly outlying acid elution results. 3. The clinical significance of decision-making by participants registered for acid elution, relating to anti-D dosing and follow-up. This is designed to identify episodes where women would be put at risk of sensitization in a similar clinical situation. 4. Return of results. Definition of unsatisfactory performance (UP) 1. An initial analytical score of 100 or an existing score of >100 but falling (see Table 3) 2. A single grossly outlying result, where the DI is <-2 or >3.5. These values are subject to review. 3. An insufficient dose of anti-D (to cover the flow cytometry method median) combined with no recommendation for follow-up. 4. An insufficient dose of anti-D (to cover the flow cytometry method median) where the screen does not trigger quantification (in-house or referral). 5. Late or non-return of results in two of three consecutive surveys. Page 10 of 27 FMH Particpants’ Manual CD F30 V5 December 2013 UK NEQAS (FMH) Participants’ Manual Definition of persistent unsatisfactory performance (PUP) 1. An analytical score of 100 where this is rising (see Table 3). 2. One episode or more of unsatisfactory performance in 2 of 3 consecutive surveys. 3. Two episode of UP due to late or non-return of results in a 12 month period. Table 3 - Definition of Borderline, UP and PUP for analytical penalty scoring Performance Performance status Score of 80-99 Borderline Score of 100+ UP Score of 100+ and falling UP Score of 100+ and rising or not falling (inc non-return) PUP Score of 100+ on two occasions in one 12 month period PUP UK laboratories identified as PUPs are contacted by the Scheme in writing. Letters are accompanied by a ‘Corrective and Preventive Action’ (CAPA) form, for the participants to document their investigation, implications for clinical practice and corrective actions. These should be returned to the Scheme to aid effective performance monitoring. PUPs are also reported to the National Quality Assurance Advisory Panel for Haematology on a quarterly basis. UK laboratories identified as UPs are contacted in writing at the discretion of the Scheme Director. Standard letters are sent to UK laboratories reaching a score of 80, suggesting a review of procedures, and offering assistance with any problems. REPORTS Individual and overall reports Each participant receives an individual, confidential report showing the overall results for the current survey within their method group, plus their own current and cumulative results to demonstrate the trends in performance. These are posted to the web within four working days of the closing date. Supplementary reports may also be distributed containing further analysis and discussion. An example of each type of report is shown in Appendices 5, 6 and 7. An anonymised copy of the acid elution and flow cytometry quantification reports are also made available on the web server. Use of reports Reports are subject to copyright and may not be distributed, published or used for publicity in any form without the written consent of the Scheme Director on each and every occasion, though the participant may share their performance data with individual clients (eg GPs, clinicians) without consultation. Page 11 of 27 FMH Particpants’ Manual CD F30 V5 December 2013 UK NEQAS (FMH) Participants’ Manual RELATED SCHEMES UK NEQAS for General Haematology Mrs Barbara De la Salle Scheme Manager, UK NEQAS (H) PO Box 14 Watford WD18 0FJ Telephone: Fax: E-mail: Website: INT + 44 (0)1923 217878 INT + 44 (0)1923 217879 [email protected] www.ukneqash.org UK NEQAS for Blood Transfusion Laboratory Practice Mrs Clare Milkins Scheme Manager, UK NEQAS (BTLP) PO Box 133 Watford WD18 0WP Telephone: INT + 44 (0)1923 217933 Fax: INT + 44 (0)1923 217934 E-mail: [email protected] Website: www.ukneqasbtlp.org UK NEQAS for Blood Coagulation Mr Tim Woods Scheme Manager, UK NEQAS (BC) Pegasus House, 463A Glossop Road Sheffield S10 2QD Telephone: Fax: E-mail: Website: 0114 267 3300 0114 267 3309 [email protected] www.ukneqasbc.org UK NEQAS for Haematinics Assays Ms Sheena Blackmore Scheme Manager, UK NEQAS (Haematinic Assays) Haematology Department Good Hope Hospital Rectory Road Sutton Coldfield B75 7RR Telephone: Fax: E-mail: Website: 0121 378 2211, xtn 2201/2 0121 311 1141 [email protected] www.ukneqas-haematinics.org.uk Page 12 of 27 FMH Particpants’ Manual CD F30 V5 December 2013 UK NEQAS (FMH) Participants’ Manual UK NEQAS for Leucocyte Immunophenotyping Dr David Barnett Scheme Manager, UK NEQAS (LI) Pegasus House, 463A Glossop Road Sheffield S10 2QD Telephone: Fax: E-mail: Website: 0114 267 3609 0114 267 3601 [email protected] www.ukneqasli.org Page 13 of 27 FMH Particpants’ Manual CD F30 V5 December 2013 UK NEQAS (FMH) Participants’ Manual Appendix 1 Instructions for web return of results and accessing reports Web return of FMH results 1. Accessing web data entry Go to www.ukneqasfmh.org and click on ‘Survey Data Entry System’ (circled) on the left hand side of the homepage. 2. Logging into the data entry pages Enter your lab's PRN in the Lab Code box. Enter the Web ID from the email we sent to you in the Identity box Enter the Web Password from the email we sent you in the Password box. Click Log in Page 14 of 27 FMH Particpants’ Manual CD F30 V5 December 2013 UK NEQAS (FMH) Participants’ Manual 3. Selecting the FMH Scheme Once you login you will be presented with this screen: Click the drop down “-- Select a programme --” Click on “Feto Maternal Haemorrhage”. The page will now list all your FMH exercises: This screen gives you details regarding each exercise: Dist. No: The unique number for the exercise. Date Issued: The date which we created the exercise. Closing Date: The date on which we will collect your submitted results. Completed: A tick under this column means you have submitted your data. It is important that after you submit your results you check that this column has a tick next to the exercise you have just completed. If it does not, we will not receive your results. Data Collected: A tick under this column means that we have collected your results. Dist. Closed: A tick under this column means the exercise is now closed and results cannot be entered or altered. Report: A tick under this column means that your online report is available to view. Questionniare: A tick in this column means that there is a questionnniare associated with the exercise that is accessible from the data entry screen. Click on the exercise for which you want to enter results to open the data entry page. Page 15 of 27 FMH Particpants’ Manual CD F30 V5 December 2013 UK NEQAS (FMH) Participants’ Manual 4. Entering, saving and submitting results To enter results, type in the date received and analysed, select the appropriate radio buttons for Sample Quality, select the appropriate methods, and type in the FMH values into the boxes displayed (these will vary according to FMH method and level of registration). Click the ‘Save’ button to save entered results without submitting them. This allows you to navigate away from the results page and when you come back everything you entered will still be there for you to view or edit. Click on the ‘Submit’ button to save and submit your results to us, after which time you will be able to view the results but not edit them. When you save or submit your results you will be redirected to the web page with all the exercises listed. If you have clicked Submit make sure that there is a tick next to the exercise you have just completed under the Completed column like this: N.B. All results that have been saved but not submitted will be collected on the closing date and assessed. Page 16 of 27 FMH Particpants’ Manual CD F30 V5 December 2013 UK NEQAS (FMH) Participants’ Manual Accessing FMH reports on the web 1. Follow steps 1 to 3 of instructions for web return of results to access the data entry pages. Exercises for which the report is ready will have a tick in the ‘Report’ column. 2. Highlight the distribution that you want the report for and click on it. This will open the Sample entry details window. Click on the ‘Reports’ button (circled below), and a new window will open listing the reports available for this exercise. 3. Click on the ‘Your Report’ folder to see your individual report. Other reports of general interest may also be available, and can be accessed by clicking on the appropriate line. Additional information that would have been circulated with paper reports will also be available here, e.g. report supplements, meeting flyers etc. Page 17 of 27 FMH Particpants’ Manual CD F30 V5 December 2013 UK NEQAS (FMH) Participants’ Manual 4. You can now view the reports, save a copy or print the reports using the appropriate buttons on the Adobe Reader menu bar. If you wish to view reports from another Survey you should go back to the list of distributions. You need to wait for around one minute between opening different PDF Reports on the Web Results Service. This is because the system caches the details of the report and another report cannot be opened until the cache is cleared. The cache is cleared after one minute (the minimum value that can be set). 5. To Log off the web server, click on the ‘Back to List’ button and then click on the ‘Logout’ button or exit from your browser in the usual way. Note: PDF copies of reports will remain on the website for six months after which they may be archived to off-line storage. If you have any problems with the website please contact us on 01923 217878 Page 18 of 27 FMH Particpants’ Manual CD F30 V5 December 2013 UK NEQAS (FMH) Participants’ Manual Appendix 2: Example result sheet (Acid elution quantification) Page 19 of 27 FMH Particpants’ Manual CD F30 V5 December 2013 UK NEQAS (FMH) Participants’ Manual Appendix 3: Example result sheet (Flow cytometry quantification) Page 20 of 27 FMH Particpants’ Manual CD F30 V5 December 2013 UK NEQAS (FMH) Participants’ Manual Appendix 4: Example result sheet (Acid elution screening only) Page 21 of 27 FMH Particpants’ Manual CD F30 V5 December 2013 UK NEQAS (FMH) Participants’ Manual Appendix 5 An example of a report for quantification by acid elution, showing the summary page and one of the three pages with details relating to each specimen. Page 22 of 27 FMH Particpants’ Manual CD F30 V5 December 2013 UK NEQAS (FMH) Participants’ Manual Page 23 of 27 FMH Particpants’ Manual CD F30 V5 December 2013 UK NEQAS (FMH) Participants’ Manual Appendix 6 An example of a report for quantification by flow cytometry, showing the summary page and one of the three pages with details relating to each specimen. Page 24 of 27 FMH Particpants’ Manual CD F30 V5 December 2013 UK NEQAS (FMH) Participants’ Manual Page 25 of 27 FMH Particpants’ Manual CD F30 V5 December 2013 UK NEQAS (FMH) Participants’ Manual Appendix 7 An example of a report for screening by acid elution Page 26 of 27 FMH Particpants’ Manual CD F30 V5 December 2013 UK NEQAS (FMH) Participants’ Manual Page 27 of 27 FMH Particpants’ Manual CD F30 V5 December 2013
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