Core Requirements draft 5th Edition
Contents
1. National Chlamydia Screening Programme NHS Data Description Field Response categories and coding Format Justify Field Record item name structure length position C13 Type of laboratory test initial test TESTTYP 1 PCR4 Numeric Left 1 71 used by laboratory to detect E 2 SDA chlamydia 3 TMA C14 Chlamydia test result test result RESULT 1 Positive Numeric Left 1 72 from the laboratory 2 Negative 3 Equivocal 4 Insufficient specimen 5 Inhibitory result Important notes on the data file e Items C1 C2 or C3 C4 C5 C8 and C14 must be completed for each test record submitted or else the record will be rejected and sent back to the source for correction e All other items should be completed in full however records will not be rejected if some fields are left blank e Additionally for C7 C11 and C12 areas are encouraged to use the unknown response categories as appropriate rather than leave the field blank 19 National Chlamydia Screening Programme Appendix 2 National chlamydia test request form uonsanb yeu 28 MSU o UE LUOD 45u0U Zi 188 ag Ui saed jugo gp BIOU 20 Z UIM X98 peu NOK SABH uoqsanb PEUL JaSus a UBM LLOP woun oN 99A 49qjuoU c ye eu wi Jue mau Uy Kes peu no AEH cisiH emxos paves oN dno onago sago Ku uibuo auna uogarduoo aye uogas Sr jo a esee NOLULO3S Ajjenuepyuoo pjay aq II Eep Iv J9 AOA pq VOD ABW a2. There is limited evidence to support screening for gonorrhoea in unselected populations Where individual programme areas are providing dual testing for chlamydia and gonorrhoea then information on both infections and consent for both tests must be obtained prior to screening Where a sample is tested for gonorrhoea as part of a dual test for chlamydia and gonorrhoea the gonorrhoea result must be reported and acted upon It is important that any additional activities do not negatively impact on the implementation and monitoring of the NCSP The NCSP highlights the following implications of dual testing which should be considered by PCTs prior to the introduction of dual testing o Evidence There is no evidence to support widespread unselected screening for gonorrhoea and evidence for selective community screening in UK settings is sparse BASHH Guidance for Gonorrhoea Testing Commissioners are advised to consider the cost implications and localised prevalence rates before commencing a widespread screening programme o Patient consent to use of data for monitoring the NCSP Additional testing is not covered by the permissions sought and agreements made nationally for chlamydia testing o Patient information leaflet The NCSP patient information leaflet does not cover any other test Separate information will be required o Staff training Knowledge of gonorrhoea its treatment and implications for the young person must be disseminated to staff at app
3. NCSPN Treatment location for all partners NCSPN1 Total number of partners known believed treated at Genito urinary Medicine N1 GUM NCSPN2 Total number of partners known believed treated at Chlamydia Screening N2 Office CSO NCSPNS3 Total number of partners known believed treated at family N3 planning contraception clinics FP NCSPN4 Total number of partners known believed treated at general practice GP N4 NCSPN5 Total number of partners known believed treated at pharmacy N5 NCSPN6 Total number of partners known believed treated at other unknown N6 locations 22 National Chlamydia Screening Programme NHS Appendix 4 Patient and Partner Notification and Management pro forma Centre for Infections Health Protection Agency 61 Colindale Avenue London NW9 5EQ www hpa org uk www chlamydiascreening nhs uk NCSP Core Data questionnaire Programme Area Name PCTs Covered Data Year Data Quarter Date of data submission Contact name Contact Number Contact Email Please read and answer these questions carefully It is the responsibility of the local chlamydia screening programmes to ensure the quality of the datasets sent to HPA and that the datasets adher to the standards set by the HPA Have you experienced any serious IT related problems which in turn has affected your data YES NO Comments quality in any way in Nm Are you aware
4. categorised in three Prescription only medicines POMs which require a prescription to be written usually by a doctor dentist nurse or other approved prescriber Pharmacy P medicines which can only be sold through a registered pharmacy under the personal supervision of a pharmacist and General Sales List GSL medicines which are deemed even safer than P medicines and can be sold in general shops as well as through pharmacies albeit often in small quantities Both GSL and P medicines can be known as Over the counter OTC medicines For more information on the mechanisms available for the prescribing supply and administration of medicines to support the development of new roles or service redesign see e Department of Health Medicines Matter 2006 e the PGD website www pgd nhs uk which contains and signposts to a wide selection of resources including examples of PGDs such as national templates for emergency care and which is supported by the National Knowledge Service Patient specific directions and patient group directions PGDs Patient specific directions A patient specific direction is the traditional written instruction from a doctor dentist or independent prescriber for medicines to be supplied or administered to a named patient for example an instruction on a ward drug chart or an instruction by a GP in medical notes for a practice nurse to administer an injection The majority of medicines are still prescribed supp
5. of any problems with your data entry at either the CSO or the laboratory O LIC gorannn aiias Have you used either the patients NHS number if available or assigned each patient a unique patient ID number as a unique identifier TS eect eet dde ces Have you either used your CSO or clinic s postcode as the patient postcode for any of your test records If Yes please remove and leave the postcode field blank L iu eer ree Have you double checked patients dates of birth particularly obvious outliers i e people aged O i c under 15 years or those over 25 years to ensure the accuracy of this information Have you identified and correctly followed up patients who are under 13 years and have been tested for chlamydia L inr 23 National Chlamydia NHS Screening Programme 7 When re importing files are you satisfied YES NO Comments that the mandatory fields have remained UNCHANGED Particularly fields such as programme area clinic ID code patient ID number or NHS number date O PT PER of birth sex date of specimen and specimen type 8 Have you kept the patients NHS number or patient ID Number UNCHANGED L ae eer es when re importing files as this is crucial for de duplication purposes 9 Have you locally double checked your O 5 EE T doi data for discrepancies inaccuracies and incompleteness 10 If you have found any problems with your L v ND data have you taken all the relevant steps to ensure t
6. on costs for fully specified contracts between the lead purchaser and all local providers e Work collaboratively with the Regional Facilitator e Be aware of the financial position of the local programme and have a secure dedicated budget line e Assist the Programme Lead in identifying a base and staffing for the local chlamydia screening office National Chlamydia Screening Programme NHS Core Requirements Sections 2 4 and 2 5 Roles of the Programme Lead and Coordinator Programme lead Key roles and responsibilities of the Programme Lead include e Chair the LCSSG e Guide delivery of the local programme its constituent PCTs and the LCSSG in compliance with the NCSP Core Requirements e Manage the allocated budget and arrange SLAs with participating PCTs e Ensure appropriate education and training for all NHS staff involved in the local programme e Act as the main point of contact for all media related enquiries on the local programme e Oversee the QA arrangements and monitor performance indicators e Ensure that there are local protocols care pathways and a testing plan e Ensure that any serious incidents related to the chlamydia screening programme are reported to the NCSP within the agreed timescale Local Programme Coordination Local coordination of the screening programme can be allocated to one individual or to a team responsible for the management of sexual health Key roles and responsibilities include e Wor
7. period What advice should be given on the use of tampons A tampon may absorb chlamydia organisms and reduce the effectiveness of a lower vaginal swab Clinicians are advised to use a urine test or an endocervical swab in this instance 10 National Chlamydia Screening Programme NHS Core Requirements Section 4 1 Laboratory requirements and checklist for contracting labs All specimens must be tested by commercially available NAATs which comply with the In vitro Diagnostics Directive From December 2003 all in vitro diagnostic devices are required to carry a CE mark In addition e Only appropriately trained staff in laboratories with suitable accreditation should carry out testing e g Clinical Pathology Accreditation UK Ltd www cpa uk co uk e Laboratories must be enrolled in a nationally recognised quality assurance scheme e Samples should be stored at 20 C or below by the laboratory following initial testing e Data regarding specimen type test platform used and test result must be collected e For positive results tests will be repeated on the same sample to exclude false positives arising from laboratory administrative errors or from contamination during specimen processing The table below shows how results should be coded Test result Code to be Description Other possible reported in HPA descriptions used quarterly file Positive 1 Initially reactive sample which is confirmed Negative
8. positives with unknown unspecified sex A4 NCSPB Positive patients 25 years with clinician confirmed treatment NCSPB1 Total number of positives treated B1 NCSPB2 Total number of positive women treated B2 NCSPB3 Total number of positive men treated B3 NCSPB4 Total number of positives with unknown unspecified sex treated B4 NCSPC Positive patients lt 25 years with patient confirmed treatment NCSPC1 Total number of positives treated C1 NCSPC2 Total number of positive women treated C2 NCSPC3 Total number of positive men treated C3 NCSPC4 Total number of positives with unknown unspecified sex treated C4 NCSPD Treatment location for all positives NCSPD1 Total number of positives treated at Genitourinary Medicine GUM D1 NCSPD2 Total number of positives treated at Chlamydia Screening Office CSO D2 NCSPDS3 Total number of positives treated at family planning contraception clinics D3 FP NCSPDA Total number of positives treated at general practice GP D4 NCSPD5 Total number of positives treated at pharmacy D5 NCSPD6 Total number of positives treated at other locations unknown locations D6 CONTACT MANAGEMENT INFORMATION ONLY OF POSITIVES FROM ABOVE NCSPE Partners reported by the positive patients reported above including untraceables NCSPE1 Total number of partners reported by the positive patients from line A1 E1 including untraceables NCSPE2 Total number of male partners reported by the positive pati
9. their results and treatment and that a log is maintained of positives partners and their management Ensure provision of relevant patient group directions PGDs Coordinators with clinical registration for prescription or operation within PGDs may be involved with patient treatment and follow up for those testing positive for infection where this can not be provided elsewhere Identify unit costs and establish value for money solutions Look for opportunities for joint procurement with other PCTs Regularly evaluate screening initiatives in order to improve local performance and provide the outcome of evaluations to the NCSP Oversee quality assurance of the local programme ensuring that regular audits are carried out and that mechanisms are in place to ensure adequate management of results treatment and partner notification Use incident reports to improve the quality of care working with providers to ensure that incidents are investigated and agreed actions taken and share best practice where appropriate possible National Chlamydia Screening Programme NHS Core requirements Section 3 2 Consent from young people under 16 The test initiator is responsible for ensuring that any young person under 16 being offered a test is competent to make an informed decision Test venues must adhere to national and local guidance and ensure Fraser competency is assessed and documented Fraser Guidelines establish that young people under 16 can gi
10. 2 Negative sample Equivocal 3 Unconfirmed initially Invalid test unconfirmed reactive sample reactive unconfirmed positive Insufficient 4 Not enough sample Unknown leaked present to test Inhibitory 5 Indeterminate Virology Standard Operating Procedure VSOP 37 is available at www hpa standardmethods org uk documents vsop pdf vsop37 pdf de Checklist for choosing a nucleic acid amplification test platform removed Laboratory requirements removed Please see Amendments on p 26 11 National Chlamydia Screening Programme NHS Core Requirements Section 5 4 Legal framework for supply and administration of medicines used by NCSP and Patient Group Directions PGDs Treatment must be administered by either medical practitioners or other clinical staff legally covered to work under PGDs Regardless of the treatment delivery method that local programme areas elect to use they must comply with clinical governance standards If PGDs are in use there must be clear documentation of who is the authorising medical consultant Special considerations will need to be put in place for practices that can prescribe but not administer therapy An template of a PGD for the administration of azithromycin is available on the NCSP website http www chlamydiascreening nhs uk ps core index html Types of licensed medicines The Medicines Act 1968 regulates the sale supply and administration of all medicines Medicines are
11. National Chlamydia Screening Programme NHS NCSP Core Requirements 5 Edition Accompanying information The following text is referred to throughout the NCSP Core Requirements 5 Edition document and provides further detail background information August 2010 amendments are in red text and detailed on p 26 Core Requirements Section 2 3 LCSSG membership and key responsibilities Local Chlamydia Screening Steering Group LCSSG The LCSSG should include representation from Commissioning General practice Community pharmacy Sexual and Reproductive Health SRH services Laboratories The Regional Facilitator Programmes are also advised to include representation from PCT IT support or Information Management Public health Health promotion Communications Key roles and responsibilities of the LCSSG include e Have a named Programme Lead with overall responsibility for the programme locally and a named chair who could be the Programme Lead or other appropriate senior representative e Hold minuted meetings at least quarterly e Develop and agree the local chlamydia testing plan e Monitor the performance of the local programme under the existing performance management framework of PCTs and SHAs and using the NCSP targets standards and guidelines e Monitor and implement solutions to QA problems highlighted by national or local QA procedures e Work collaboratively across the PCT s in the programme area to develop and agree
12. an alternative sample type Information regarding manufacturers recommendation including specimen type first void quantity and time since last passed urine should be adhered to Additional information is needed for samples requiring the insertion of preservation pouches Urine sample should be stabilised by refrigeration or by other means prior to transport to the lab refer to manufacturers recommendations for sample stability National Chlamydia Screening Programme NHS Vulvovaginal swabs e A private area with hand washing facilities will need to be made available for on site swabbing Alternatively after receiving instructions specimens can be obtained off site and returned at a later stage e An appropriate sterile swab and instructions should be provided Example instructions Ila First wash and dry your hands and then take the cotton wool swab out of the packing by twisting the cap g Rub the soft cotton bud ends not the plastic sticks gently just inside the opening to your vagina Rotate the cotton buds pressing firmly on the moist part inside Please make sure they touch the skin inside your vagina Place the swab back into the small plastic tube Press the cap on tightly Ensure your name and number are on the tube Place the tube into the plastic specimen bag and hand it back to the clinic staff Cervical specimens If a planned cervical examination is being undertaken the opportunity should be taken for a c
13. ay be stored and processed within 30 days after expression if kept at 2 30 C or within 180 days after the date of expression if kept frozen at 20 C Endocervical urethral swabs must be stored and transported to the laboratory at 2 27 C within 4 6 days URINE Urine should be collected in sterile plastic preservative free containers and can be transported either neat or using the BD Urine Preservative Transport UPT Qx see table below for further details Urine should be collected in sterile plastic preservative free containers and can be transported either neat or using the BD Urine Preservative Transport UPT see table below for further details URINE SAMPLES FOR BD Probetec ONLY Urine Specimen Type to be NEAT UPT Processed Urine stored at 2 Urine stored at 2 8 C 30C transfer to UPT within 24 transferred to hours UPT within 8 hours Temperature EonciBiah sor 230C 28C 20C 2 30 C 2 30 C 20C Transport to Test Site and Storage Process Up to 30 Up to7 Up to 2 Up to 30 days Up to 30 Upto2 Specimen hours of days from months after transfer to days months after according to collection date of from date UPT from collection Instructions collection of date of collection collection National Chlamydia Screening Programme URINE Samples for BD Viper XTR ONLY Urine Specimen Q UPT NEAT Type to be Processed Ur
14. ccess To Health Records Requests 2010 e Data Protection Act 1998 e NHS Trusts and Primary Care Trusts Sexually Transmitted Diseases Directions 2000 e SSHA The Manual for Sexual Health Advisers London SSHA 20046 15 National Chlamydia Screening Programme NHS Core Requirements Section 9 1 NCSP data application and user manual The NCSP database currently runs as a Windows based application in the HPA A need arose for enhancements to the system which included the creation of a new web based system The web application was developed and launched in 2008 and provides the following core functionalities e Security authentication of authorized users e User account management e Automatic generation of clinic codes e Search view and submit functions for Core data and Patient and Partner Notification and Management data The link to the web based application and user manual are available at http www chlamydiascreening nhs uk ps data it html Core Requirements Section 9 1 Future Datasets The NCSP is moving towards comprehensive reporting of all chlamydia testing data in England in 2011 to evaluate the impact that NCSP is having on the infection and to better understand the epidemiology Reporting of data will be through a disaggregate lab data return on all chlamydia tests and all dual chlamydia and gonorrhoea tests in all settings including GUM NCSP is in the process of putting forward a Data Set Change Notice applicati
15. e for which they were specifically collected unless the consent of the providers of that information has been confirmed e Enquires relating to confidential data should only be accepted by those people mentioned above 17 National Chlamydia Screening Programme NHS Appendix 1 Technical specifications for the NCSP Core data in CSV MS Access comma delimited export format s Data Description Field Response categories and coding Format Justify Field Record item name structure length position C1 Clinic ID code unique ID number CLINICID A unique ID code for the setting String Right 5 10 1 10 for each participating setting assigned by HPA NB A web based facility for CSOs to acquire setting codes is under development C2 Unique patient ID number unique PATID Any String Right 10 11 20 ID code assigned to each patient orC3 NHS number unique ID code NHSID Any String Right 10 21 30 assigned by the NHS for all registered patients C4 Sex the anatomic sex of the SEX 1 Male Numeric Left 1 31 patient not their gender identity 2 Female 0 Not known 9 Not specified C5 Date of birth date of birth as DOB DD MM YYYY Date Left 10 32 41 reported by the patient C6 Postal code of residence POST Any String Left 8 42 49 C7 Ethnicity ethnic group based on ETHNIC 1 White Numeric Left 2 50 51 ONS classification system as 11 White British reported by the patient 12 White Irish 13 A
16. e immediately at any time Capsules according to the manufacturing SPC are affected by the intake of food and carry the recommendation to take on an empty stomach i e avoid food 1 hour before taking or for 2 hours after taking A literal interpretation could prevent some individuals from taking the treatment on site This has multiple implications Inability to verify treatment has been taken risk of failure to take treatment issued under PGD would become chargeable if taken away by person This problem arises from the relatively low bioavailability of the drug in the plasma Some clinicians have taken a pragmatic approach of giving the treatment immediately and requesting patients to avoid food for 2 hours after Further information is available at http www tevauk com webroot files products 49 files Azithromycin 20250mg amp 500mg 20tablets 200028 9 0584 5 pdf http www tevauk com webroot files products 81 8 files Azithromycin 20250mg 20capsules 2010622 04 74 pdf 14 National Chlamydia Screening Programme NHS Core Requirements Section 5 5 Information sharing between GUM and the NCSP The following statement issued in September 2006 is a joint position statement by BASHH SSHA and the NCSP It clarifies the position regarding sharing of information between GUM and the different healthcare professionals within the NCSP Purpose of statement To establish communication pathways between GUM and chlamydia screening programmes CSPs t
17. ents from line A1 E2 NCSPES3 Total number of female partners reported by the positive patients from line E3 A1 NCSPEA4 Total number of partners with unknown sex reported by positive patients E4 from line A1 NCSPF Number of partners reported by positive patients in A1 NCSPF1 Total number of positives reporting only one partner F1x1 NCSPF2 Total number of positives reporting just two partners F2x2 NCSPF3 Total number of positives reporting just three partners F3x3 NCSPF4 Total number of positives reporting more than three partners F4 see guidance notes 21 National Chlamydia Screening Programme NCSPH Contactable partners follow up NCSPH1 Total number of contactable partners known believed informed H1 NCSPH2 Total number of partners known believed informed by positives H2 NCSPHS3 Total number of partners known believed informed by clinical staff H3 NCSPH4 Total number of partners that attended on their own volition or contacted via H4 other route NCSPH6 Total number of partners that were not contacted including untraceable H6 partners NCSPJ Partners known believed tested NCSPJ1 Total number of partners known believed tested J1 NCSPM Treatment of partners NCSPM 1 Total number of partners with clinician confirmed treatment M1 NCSPMe Total number of partners with treatment confirmed by index patient M2
18. ervical swab to be collected according to the manufacturer s recommendations If a cervical examination is not being performed participants should be offered the choice of a urine sample or self taken vulvovaginal swab Cervical examination should not be carried out for the sole purpose of obtaining a specimen sample for testing Specimen collection and transport These notes are for general guidance only and intend to set out what is in the test manufacturer s instructions For further information please consult your local laboratory However please bear in mind e Several studies have shown that posted samples are suitable for testing even if transport time is up to one week e Similarly there is a great deal of evidence to suggest that vulvovaginal swabs are suitable samples although they are not validated by test manufacturers with the exception of Gen Probe APTIMA and Abbott RealTime Note also the following e itis good practice to store all samples at 449C i e to refrigerate them between collection and transport to the laboratory e Ambient room temperature is 15 27 C e Urine should be a first catch sample The appropriate sample collection kits approved by test manufacturers should always be used National Chlamydia Screening Programme The tables below give further information Gen Probe Roche Abbott SWABS Transport swab For cobas 4800 see below Collections process identical for specimens
19. hat the error is corrected and data quality is maintained 11 Locally are you satisfied with all the steps O E E E ei ieroo imus taken to ensure the integrity accuracy and completeness of your data 12 If you have had major issues with integrity accuracy and completeness of your data i Who did you report these problems essem to at NCSP Datateam 1 226m ii What action was agreed eesss IRI iii Has this action been taken General Comments Data check carried out with National Chlamydia Screening Programme References Department of Health Best practice guidance for doctors and other health professionals on the provision of advice and treatment to young people under 16 on contraception sexual and reproductive health 2004 General Medical Council 0 18 Years guidance for all doctors 2007 3 BASHH Clinical Effectiveness Group UK National Guideline for the Management of Genital Tract Infection with Chlamydia trachomatis 2006 BASHH Chlamydia Trachomatis Screening and Testing Draft Guidelines 2010 Annan N T et al Rectal chlamydia a reservoir of undiagnosed infection in men who have sex with men Sex Transm Infect 2009 85 176 179 Morr SA et al Mailed home obtained urine specimens a reliable screening approach for detecting asymptomatic Chlamydia trachomatis infections Journal of Clinical Microbiology 1999 37 4 976 980 Skidmore S Horner P Herring A Sell J Paul Tho
20. ine Handling Store urine specimen at 2 30 c and Options Prior To transfer to q upt within 8 h of collection Transfer To Q or UPT store urine specimen at 2 8 c and transfer to q upt within 24 h of collection or Transfer to Q UPT immediately Temperature Condition for Storage and 2 8 C 2 30 C 20 C 2 8 C 2 30 C 20 C Transport to Test Site Process and Within 30 days after Within 180 Within 7 Within 30 h Within 180 Test Specimen transfer to Q UPT days after days of of collection days of According to transfer to collection collection Instructions Q UPT National Chlamydia Screening Programme NHS Core Requirements Section 3 6 Clinical FAQs on the timing of tests How many days should pass after unprotected sex before a chlamydia test is undertaken The NCSP recommends e Test immediately e Repeat the test in 3 5 weeks If the first test is positive it may be because the index person already has chlamydia or in the case of the female that the test is picking up chlamydia in the partner s semen In the latter case the test may revert to negative after a few days and then if the woman develops chlamydia it will change back to being positive hence the recommendation to repeat the test in 3 5 weeks How often can a test be repeated It is advised not to repeat a test within five weeks after treatment of a positive result or within six weeks if treated with azithromycin NAATs are very sensitive and
21. k with the Programme Lead and Regional Facilitator to ensure implementation and delivery of the local programme in alignment with PCT accountability structures and as agreed by the LCSSG in compliance with the NCSP Core Requirements e Compile agree and monitor progress against the local testing plan e Performance manage all providers giving regular feedback on screening rates against local and national targets Embed the programme within local core services and identify where there is most potential to increase screening rates Identify and work with local GP and pharmacy champions to increase screening and improve quality of services Co ordinate education and training for individuals involved in the local programme Set up and liaise with screening sites devolving treatment and PN and other work such as making up screening packs to other providers where feasible Provide strong leadership and local championing of the screening programme at local PCT regional and SHA meetings as needed Keep up to date with national and regional health policy and plans Develop together with providers local protocols care pathways and a testing plan Agree pathways for the collation and submission of data Ensure that core data and patient management and partner follow up data are sent promptly to HPA Ensure that data is collected for audits where required Provide other activity reports as requested Ensure that all screened people receive
22. ke local and national advice from sexual health service providers before considering dual testing Further information on gonorrhoea testing is available from BASSH Guidance for Gonorrhoea Testing in England and Wales 2010 Please see Amendments on p 26 National Chlamydia Screening Programme NHS Core Requirements p12 section 3 6 Detailed advice concerning specimen collection Testing may be undertaken using first void urine samples for men and women self taken vulvovaginal swabs or cervical swabs if a speculum examination is being carried out as part of routine clinical care The decision regarding which of these specimens to use will be made by the LCSSG in collaboration with the local clinicians and microbiologists participating in the programme The following should be noted e First void urine is the sample of choice for men and for women who decline other sampling e MSM should be offered the option of attending a venue competent to offer rectal chlamydia and gonorrhoea swabbing since there is a high rate of asymptomatic rectal infection in those practicing ano receptive sex Care must be taken with all samples to avoid cross contamination After collection samples including self taken samples obtained off site should be placed in an individual specimen bag along with a completed request form Information on collection transport storage and handling of specimens for both young people and staff should be provided Informati
23. lied or administered through this process As a patient specific direction is individually tailored to the needs of a single patient it should be used in preference to a PGD wherever appropriate Patient group directions A PGD is a written instruction for the supply or administration of a medicine or medicines to groups of patients who may not be individually identified before presenting for treatment The supply and administration of medicines under PGDs should be reserved for the limited number of situations where this offers an advantage for patient care without compromising patient safety Use of PGDs is appropriate when e the medicines to be given and the circumstances under which they should be given can be clearly defined in the written direction and there is a robust evidence base e there are high volume groups of patients who present for treatment e medicines are to be supplied and or administered by one of the registered health professionals who are allowed to use PGDs Where clear criteria are included within the PGD the PGD can include a flexible dose range so that the healthcare professional can select the most appropriate dose for each patient The majority of clinical care should be provided on an individual patient specific basis A PGD should be drawn up locally by doctors pharmacists or other health professionals and must meet certain legal criteria Each PGD must be signed by a senior doctor or dentist as appr
24. lity questionnaire that each programme area should complete and send in with their core data on a quarterly basis The aims of this questionnaire are to flag up to local programmes any issues that might compromise their data quality and significantly reduce the risk of areas submitting incorrect figures A sample of this questionnaire can be found in Appendix 4 Core requirements Section 9 5 Confidentiality Confidential data i e clinic or NHS number date of birth and postcode must not be disclosed to anyone other than the provider of the data local programme staff handling the data and the NCSP No data may be disclosed to any other parties unless in aggregate form and with the agreement of those responsible for their provision Additional confidentiality measures include but are not limited to the following e The full postcode will only be used to allocate tests into geographic areas by SHA PCT local authority and ward after which it will be stripped from the file and kept in a separate password secured database A unique identifier generated by the HPA will be used to link tests from the original database to the postcode specific one e While data are held locally access to records should be restricted to the Programme Coordinator and colleagues who help with administration under supervision Restriction of access to such users must form part of the system security e At no time should data be used for any purposes other than thos
25. m xor sappy AQ nof ipejuoo LL Om Je SPOUPSL URIIBH OM UI HH 656614 SABO si UNSA ANA ji NOK PEIO Uto ar yeu puituodiui sit Siejop 123005 M3 Wao Agunog 90 spoasodeuon 2 ajo ea S Iv13ad INAY d wu Cle we 19 i59 o3e20gei jo odiy L p A1NO asn avi z NOILLOaS 11w90v MO L1 VVOV LivEOV 0 papaooo eq zenuw SP00 BOR PEIO 20 2450 Jo VIDS uie papoda eq ueo suoydufe aou assaja LS yo swords spodss ih SHEEP ou S7130 JLS 9NU SAL ATNO 44W19 t NOLLIS ji oui 1e dis yo seo uou ones ojdind ay y pue suogaes ayjduoo o siuoped t pue suones ejejduioo o1 WEIS SNOLLOFIM ISNI 20 National Chlamydia Screening Programme Appendix 3 Patient and Partner Notification and Management pro forma LINE Description Data ITEM PATIENT MANAGEMENT INFORMATION ONLY OPPORTUNISTIC SCREENING OF UNDER 25 YEAR OLDS outside GUM settings NOT CONTACTS NCSPA Positive patients lt 25 years opportunistically screened outside GUM settings through the NCSP NCSPA1 Total number of positives A1 NCSPA2 Total number of positive women A2 NCSPAS Total number of positive men A3 NCSPA4 Total number of
26. management of under 16s The signatories of the PGD will have ultimate responsibility for its use in this age group Staff using the PGD in the under 16s must have received the appropriate training and be aware of local care pathways and the nominated person s responsible for child protection issues Off label use in PGDs A PGD can include an off label use using a licensed product for an unlicensed use provided that there is appropriate and robust ideally national evidence As with any off label use adequate information needs to be made available the patient Such off label use occurs in chlamydia screening with the use of azithromycin in children and pregnant women e Azithromycin in children The summary of product characteristics SPC for the Pfizer product Zithromax does not specify as of March 2007 what a child is but there is discussion regarding weight needing to be gt 45kg Pfizer considers that persons aged 12 years or over have a sufficiently mature metabolic mechanism to deal with the stat dose even if their weight is marginally under 45kg Guidance from the US Centers for Disease Control and Prevention states that children over the age of 8 years regardless of weight can receive the adult stat dose At present there is no definitive guidance from the National Chlamydia Screening Programme NCSP on this topic and individual PCTs will need to agree locally what stance they wish to take on this and to document an
27. mas J et al Vulvovaginal swab or first catch urine specimen to detect Chlamydia trachomatis in women in a community setting J Clin Microbiol 2006 44 4389 94 Wiggins R Graf S Low N Horner PJ Real time quantitative PCR to determine chlamydial load in men and women in a community setting J Clin Microbiol 2009 47 1824 9 Gaydos CA Crotchfelt et al Molecular amplification assays to detect chlamydial infections in urine specimens from high school female students and to monitor the persistence of chlamydial DNA after therapy J Infect Dis 1998 177 417 24 Morre SA et al Monitoring of Chlamydia trachomatis infections after antibiotic treatment using RNA detection by nucleic acid sequence based amplification J Clin Pathol Mol Pathol 1998 51 149 154 Health Protection Agency Chlamydia trachomatis Infection Testing by Nucleic Acid Amplification Tests NAATs 2008 12 Department of Health Medicines Matters 2006 13 Department of Health Guidance for Access To Health Records Requests London Department of Health 2010 14 Data Protection Act 1998 Available at http www opsi gov uk acts acts1998 ukpga 19980029 en 1 15 NHS Trusts and Primary Care Trusts Sexually Transmitted Diseases Directions 2000 Department of Health 2000 Society of Sexual Health Advisors The SSHA manual for sexual health advisors 2004 25 National Chlamydia Screening Programme Amendments August 2010 o The NCSP updated its guidance o
28. may pick up chlamydial nucleic acids from non viable organisms If a patient requesting a chlamydia test is currently taking antibiotics for an unrelated infection how many days should pass before a chlamydia test should be undertaken so that false negatives would not be a problem e f the antibiotic being used could also be used to treat chlamydia then it is important to consider whether this index patient may have therefore been indirectly treated for chlamydia However the partner may still have the infection and as they have not been treated and so may re infect the index case Clinicians should consider discussing partner notification if appropriate e If the antibiotic is one that has no effect on chlamydia then timing of the test does not matter What advice should be given to a woman who requests a chlamydia test but indicates that her period started today How many days if any should elapse before swabs are undertaken When using NAATSs this does not matter there is no interference seen with blood Gen Probe Optima Combo 2 Assay 2009 available at http www gen probe com pdfs pi 501798RevA pdf BD guidance available at http www bd com ds technicalCenter inserts pkglnserts aspzPF8 However if a woman felt uncomfortable providing a lower vaginal or endocervical swab at this time or if she was using a tampon see below a urine test could be used instead Alternatively she could be advised to wait until after her
29. men Collection Kit After collection transport and store transport tube at 2 C to 30 C for up to 14 days or if longer storage is needed store at 10 C or below for up to 90 days Cobas 4800 Swab and urine specimens collected with the cobas amp PCR Female Swab Sample Kit and cobas PCR Urine Sample Kit respectively can be transported at room temperature 15 30 C Swab and urine specimens collected with the cobas amp PCR Female Swab Sample Kit and cobas PCR Urine Sample Kit respectively may be stored at 2 30 C for up to 90 days once the specimen has been stabilized in the cobas PCR Media Urine specimens must be transferred into the cobas amp PCR Media tube stabilized immediately If specimens cannot be transferred immediately they can be stored at 2 to 30 C for up to 24 hours National Chlamydia Screening Programme NHS BD Viper XTR BD Probetec SWAB The endocervical and the male urethral swab specimens must be stored and transported to the laboratory and or test site within 30 days after collection if kept at 2 30 C or within 180 days after collection if kept frozen at 20 C Patient collected vaginal swab specimens must be stored and transported to the laboratory and or test site within 14 days after collection if kept at 2 30 C or within 180 days after collection if kept frozen at 20 C Patient collected vaginal swab specimens that are expressed in CT GC Qx Swab Diluent m
30. n dual testing and published a position statement This is now reproduced on p4 o Removal of Checklist for choosing a nucleic acid amplification test platform since all labs use NAATs o Removal of Laboratory requirements for NAATs since all labs use NAATs 26
31. ny other white background 8 Mixed 81 White and black Caribbean 82 White and black African 83 White and Asian 84 Any other mixed background 4 Black or black British 2 Black Caribbean 3 Black African 4 Any other black background C7 Ethnicity ethnic group based on 5 Asian or Asian British cont ONS classification system as 51 Indian reported by the patient 52 Pakistani 53 Bangladeshi 54 Any other Asian background 7 Other ethnic group 6 Chinese 7 Any other ethnic group 99 Unknown not specified C8 Date of attendance date DOA DD MM YYYY Date Left 10 52 61 specimen was collected from the patient C9 Reason s for test why the REASTES A03 Chlamydia screening String Left 6 62 67 patient is receiving a chlamydia T A04 Diagnostic testing test A08 Contact of chlamydia positive A11 Symptoms A11 can be reported with either A03 A04 or A08 C10 Specimen type type of sample SPECTYP 1 Urine sample Numeric Left 1 68 sent to the laboratory for testing E 2 Cervical swab 3 Vulvovaginal swab 4 Urethral swab 5 Other C11 New sex partner last 3 months NEWSP 1 Yes Numeric Left 1 69 did the patient report a new 2 No sexual partner in the last 3 3 Unknown months 9 Patient declined to answer C12 Two or more sexual partners in MULTSP 1 Yes Numeric Left 1 70 last 12 months did the patient 2 No report two or more sexual 3 Unknown partners in the last 9 Patient declined to answer 12 months 18
32. o enhance the care of people with chlamydia and their partners within a framework of confidentiality Primarily this will be for the purpose of confirming index patient or partner treatment Discussions for advice on clinical management or for referral of complicated cases to GUM may also be covered by this statement e The information shared would be for the purpose of the treatment of the patient and or the prevention of the spread of the disease and therefore complies with NHS and PCTs STD directions 2000 Information may also be shared for surveillance and agreed audit purposes Statement Information that allows individuals to be managed effectively for genital chlamydial infections may be exchanged between health care teams working in GUM and chlamydia screening programmes operating within the NCSP e Information may include confirmation of tests taken results treatment given and follow up arrangements for a named individual Information will be exchanged verbally where possible Staff identities will be verified before information is exchanged Information exchanged will be documented in the relevant patient record Clinical staff and administrative staff working under their direction working in GUM the chlamydia screening office or other clinical screening venues operating within the NCSP This statement does not cover communication with non clinical screening sites Refer also to e Department of Health Guidance for A
33. on to allow women to make an informed choice regarding which type of sample should also be provided Disposable equipment should be handled according to local infection control policy Requirements for specimen collection Urine specimens for men and women e Participants should be supplied with a labelled collection pot or kit and instructions e A Suitable toilet and hand washing facilities will need to be available and instructions given to allow participants to provide the urine sample Example instructions for collecting a sample 1 You should not have passed urine in the last hour Some platforms may require two hours If you have please tell the person asking you to do this specimen BEFORE you do anything else Wash and dry your hands As soon as you start pass the first part of your urine into the bottle about half full Pass the rest of your urine into the toilet If you have been given a grey teabag shaped pouch insert it into the urine now Screw the cap back on tightly Ensure your name and number are on the specimen 7 Place the specimen into the plastic specimen bag and hand it back to the clinic staff If the young person is unable to pass urine or has voided urine outside the manufacturers recommendations they should be given specimen collection equipment and instructions and asked to return another fresh sample as soon as possible Women may also be offered a self taken vulvovaginal swab or offered
34. on to the ISB for the Chlamydia Testing Activity Dataset CTAD Core Requirements Section 9 2 Further information on the NCSP dataset The NCSP Core Dataset has Review of Central Returns ROCR and National Information Governance Board for Health and Social Care NIGB approval All core data should be reported via the NCSP web based application in a comma delimited file format CSV A sample template of the NCSP test request form can be found in Appendix 2 Core Requirements Section 9 3 Non NCSP non GUM data All non NCSP non GUM data submitted should be accompanied by a completed questionnaire Labs should report data on tests allocated to all PCTs and not restrict reporting to tests relating to PCTs who commission their services Non NCSP non GUM data should not include tests reported on the NCSP form or tests done in GUM clinics All non NCSP non GUM data should be reported via email to the NCSP Information Management team in the pre specified format in an Excel file Core Requirements Section 9 4 Patient Management and Partner follow up required data A sample of the Patient and Partner Notification and Management pro forma can be found in Appendix 3 16 National Chlamydia Screening Programme NHS Core requirements Section 9 5 Data management Maintaining high data quality integrity completeness and accuracy are all responsibilities of each local programme area To help local programmes we have developed a data qua
35. opriate and by a senior pharmacist both of whom should have been involved in developing the PGD Additionally the PGD must be authorised by an appropriate body usually a primary care trust PCT or NHS hospital trust for NHS services Accountability for any PGD lies with the signatories to that PGD 12 National Chlamydia Screening Boats NHS The employing organisations have a legal duty of care and are responsible for ensuring that the staff they employ are properly trained and competent and that they undertake only those responsibilities specified in agreed job descriptions e A list must be kept within each organisation detailing the individuals who approved the PGD and the individuals named as competent to use specific PGDs A designated senior person in each profession locally should be responsible for ensuring that only fully competent qualified and trained professionals operate within PGDs For a PGD to be implemented the signatures of all professionals who will be working within the PGD must be obtained as well as the signatures of those giving organisational approval e Professionals work under patient group directions PGDs as named individuals and no delegation of the supply or administration of medicines is permissible Non registered staff cannot administer medicines using a PGD and cannot train others to prescribe medicines PGDs can only be used by the following registered healthcare professionals acting as named individual
36. ropriate levels of complexity o Lab Accreditation and standards Labs providing dual testing should be CPA accredited Laboratories should not test for conditions that have not been specifically requested o Treatment regimes and follow up recommendations will vary Pathways should be reviewed to ensure that they are appropriate o Partner notification recommendations will vary and should be reviewed in the light of dual testing o Interpretation of results may be needed E g in an area of low overall prevalence of gonorrhoea positive results will require formal confirmation since the positive predictive value of a positive test could be low Supplementary testing with a second NAAT using a different target is recommended for confirmation Repeat testing of the residual NAAT is performed by many laboratories and is a reproducibility check for the testing process but not a confirmation Test initiators should be prepared to explain test results and should have robust recall and re test protocols Those with positive results should be referred to a level 2 or 3 service in accordance with the BASHH STI management guidance for culture for antibiotic sensitivity testing treatment and partner notification o Websites where postal kits are sent out it should be made clear on the website that the test will also be for gonorrhoea o Clinical risk for fail safe for other infections needs to be delineated These are not exhaustive The LCSSG is advised to ta
37. s nurses midwives health visitors ambulance paramedics optometrists orthoptists chiropodists podiatrists radiographers physiotherapists pharmacists dieticians occupational therapists prosthetists and orthotists and speech and language therapists All professionals must act within their appropriate professional code of practice and their own level of expertise and competence The use of PGDs must also be consistent with appropriate professional relationships and accountability Supply Treatments should only be supplied pre packaged patient ready in appropriately labelled packs Pre packaged treatments should be obtained from a licensed hospital or PCT pharmacy pre packing unit The packs must either be supplied against a valid individual prescription or PGD or be supplied by a practitioner who is accredited to work with under a PGD The exception to this is pharmacists who will dispense treatment from bulk stock This should be done in accordance with dispensing and labelling regulations guidance is available from the Royal Pharmaceutical Society of Great Britain www rpsgb org uk Medicines Act 1968 and Medicines and Healthcare Products Advisory Agency www mhra gove uk PGDs and the under 16s There is no specific legislation regarding use of PGDs in those aged under 16 years It is up to the individual PCT or host PCT if covering several PCTs to ensure that the document includes the locally agreed policy for the
38. to the all swabs and urines with single laboratory in the swab collection device specimen transport Endocervical swabs_must be medium and tube Must collected and transported in be transported at 2 to MART medium Remel 30 and tested within Samples may be transported at Transport swab specimen using 60 days room temperature ie 15 30 C the multi Collect Specimen for testing within 14 days of Collection Kit After collection collection transport and store transport tube at 2 C to 30 C for up to 14 days or if longer storage is needed store at 10 C or below for up to 90 days Urine specimens can Urine specimens must be Collections process identical for URINE be transported to the collected in clean polypropylene all swabs and urines with single laboratory at 2 to 30 in either the collection device or in the APTIMA urine specimen transport tube NB Urine specimens must be transferred into the APTIMA urine specimen transport tube within 24 hours of collection and before testing Once in the transport tube urine specimens can be stored at 2 to 30 for 30 days containers which have no added preservatives Samples can be transported at 15 30 C but must arrive in the laboratory within 24 hours of collection Refrigerate until shipment to ensure that the time at 15 30 C does not exceed 24 hours and ship as soon as possible collection device Transport swab specimen using the multi Collect Speci
39. ve consent provided that the health professional is convinced that e The young person understands the health professional s advice including risks e The young person is aware that the health professional cannot inform the parents that s he is seeking sexual health advice without consent nor persuade the young person to inform the parents e The young person is very likely to begin or continue having intercourse with or without contraceptive sexual health treatment e Unless s he receives contraceptive advice or treatment the young person s physical or mental health or both are likely to suffer e The young person s best interests require the health professional to give contraceptive advice treatment or both without parental consent The Department of Health s Best practice guidance for doctors and other health professionals on the provision of advice and treatment to young people under 16 on contraception sexual and reproductive health is available at http www dh gov uk prod_consum_dh groups dh_digitalassets dh en documents digitalasset dh 081830 pdf See also GMC 0 18 Years guidance for all doctors http www gmc uk org guidance ethical guidance children guidance index asp National Chlamydia Screening Programme NHS Core requirements Section 3 4 Dual screening for Chlamydia and Gonorrhoea The National Chlamydia Screening Programmes formal position statement on dual testing for chlamydia and gonorrhoea August 2010
40. y associated decisions 13 National Chlamydia Screening Programme NHS e Azithromycin in pregnancy The safety of azithromycin in pregnancy and lactating mothers has not yet been fully assessed although available data indicate that it is safe The British National Formulary BNF recommends its use only if no alternative is available WHO guidelines recommend a 1g stat dose in pregnancy The alternative is erythromycin 500mg bd for 14 days This drug has a significant side effect profile and some individuals may find it unacceptable or be unable to tolerate the regime The NCSP advises that clinicians follow the recommendations made by the British National Formulary www bnf org uk bnf and the British Association for Sexual Health and HIV BASHH Note The generic azithromycin produced by TEVA UK Ltd has a similar SPC to that of Pfizer s product regarding age weight and pregnancy Presentation of Azithromycin PCTs should be aware that azithromycin is available generically in both capsule and tablet presentations When choosing the presentation PCTs should take into account o Market availability o Drug tariff price o Ease of administration o The fact that manufacturing Summary of Product Characteristics SPCs vary between tablets and capsules and consideration may need to be given to this during the patient consultation Tablets are film coated and unaffected by the in take of food allowing individuals to take the treatment dos
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