Document title: fill in the title of your SOP
Contents
1. Regular tasks in the management of the POCT service are carried out Persistent problems are notified to senior departmental staff Clinical Biochemistry Staff on call On call staff should not leave the laboratory to trouble shoot POCT as this compromises the on call service there is no back up laboratory service for measurement of fibronectin Users ensure Their annual training is kept up to date and they are competent to practice C Documents and Settings nasmith Local Settings Temp LI BIO POCTFFNUs_4FEBCCEC doc Author N A Vaughan Authorised by N A Vaughan Luton and Dunstable Hospital NHS Foundation Trust CONTROLLED LI BIO POCTFFNUs Clinical Biochemistry Edition Number 1 0 Page 6 of 17 PRINTED COPIES UNCONTROLLED UNLESS MARKED CONTROLLED IN RED The correct specimen is obtained from the correct patient under the correct circumstances and the correct specimen is tested The specimen is collected with minimal discomfort to the patient The test is carried out according to the manufacturer s instructions The test is correctly recorded in the device or record book and in the patient s notes The specimen is disposed of according to the Trust Waste Management Policy Clinical biochemistry POCT staff are informed in the event of problems with the device If issued with a log on code or barcode this is kept secure and used only be themselves Sharing or photocopying barcodes log on details is a disciplinary offence ac2. 1 2 The Specimen The specimen should be obtained from the posterior fornix of the vagina during a speculum examination The polyester tipped applicator provided in the Rapid fFN Specimen collection kit should be inserted into the vagina and lightly rotated across the posterior fornix for approximately 10 seconds to absorb the cervicovaginal secretions Please note no lubricants soaps or creams etc can be used in collecting this specimen as they will prevent absorption of fibronectin onto the applicator water may be used if required Once the specimen is obtained carefully remove the applicator from the vagina and immerse the tip in the tube of buffer provided in the collection kit Break the shaft at the scored area this should be almost level with the top of the tube Align the shaft with the hole inside the tube cap and push down lightly over the shaft sealing the tube Label the tube with the patient s details The patient s first name surname and hospital number must be included along with date and time of collection Specimens will normally be tested straight away but are stable for 8 hours at room temperature 1 4 Spillage of Clinical and Non Clinical Waste Spillage of Clinical and Non clinical waste must be dealt with according to the Trust Health and Safety policy C Documents and Settings nasmith Local Settings Temp LI BIO POCTFFNUs_4FEBCCEC doc Author N A Vaughan Authorised by N A Vaughan Luton and Dunstable Hospital NHS
3. SYTEM PASS if the analyser is OK to use for patient testing 7 Stick the printed label into the fibronectin record book If a result of FAIL or INVALID occurs this should be repeated in the first instance Contact the POCT team if you are not able to rectify this on Ext 7991 No patient testing can be carried out until a PASS is obtained 2 6 2 Liquid Internal Quality Control Liquid IQC both positive and negative controls must be run on every new delivery of cassettes received by delivery suite and with each new lot number In addition the POCT team will carry out Liquid IQC on a monthly basis alternating between the negative and positive control When opening a new bottle of QC write the date of first use on the bottle 1 Allow the controls to warm to room temperature before testing and invert to mix 2 Select LIQUID CONTROLS from the main menu of the analyser 3 Enter your User ID and press ENTER 4 Enter the cassette lot number printed on the foil pouch of the cassettes The first three characters should be displayed on the screen ensure they match the first three of the cassette lot number If they do not refer to Section 2 5 Calibration Enter the remaining numbers of the lot number and press ENTER 5 Enter the control lot number and press enter DE Ge E C Documents and Settings nasmith Local Settings Temp LI BIO POCTFFNUs_4FEBCCEC doc Author N A Vaughan Authorised by N A Vaughan Luton and Dunstable Hospital NHS Found
4. Procedute sierici erra N E S 11 2 9 RESUS scassotiaianastoxvexsicnsivaandciteaxsusiaashdcoearsdelasnesdiaeckriamssariaceenaniciaessddanumlaashidiasnicaees 12 2 9 MaNtenaNCE inosine a e a ae E PEE ASEE E OE ERE S EETA PE iR EnS 12 FN ESE EET aE e EE E E E E E E A 12 292 Weekly e a nace ea a e a a eases 12 2 9 3 Changing the printer labels cssctssexsixensecsncensanvartstinsa wibverssecindasneventenceetceousieusienentenors 12 2 10 Troubleshogti e sarisini rnnr eii REE E EEE EER 13 3 POST EXAMINATION PROCESS sj sccsisnaceastceseeacetavsstesnsunwon edenesceansnoauens qunensteysend sonasearaneons 13 3 1 IRC TOPS CSV AUIS oscars cielo gerd riar ina E A lebanese EER TERRY 13 3 2 R portmg the RESINS ipress inene a R A EE STEA 13 SA Reviewing Previous IR GSUILS i csscss vss cxxsausnadieanqonusnueeonueeierrianasadknedesaventionedentacsimeousiuelenuianees 14 3 5 Performance Criteria Umer aint y osivicicesiesdcwsaesdeoeiaideroniindiaasiatiannabakoviaieniaraandes 14 3 6 Documentation erases os Sepieasechivensenuencenieoansnsasetavsass lavecamt canteage Geum eoanveasaiGanenumsabieahiuencataeeeet 14 3 7 Audit of Results and IMAI AMON cients oxscesnecesedentassaseendevacties mawsetani sesei iiis 15 3 8 Comparability isise sesa erns e E EA REET REA E S EEEE SNE SEOSER 15 4 SELF ASSESSMENT COMPETENCY FORM ssssssseessssssssisressesesresresessessissesessesresrese 16 C Documents and Settings nasmith Local Settings Temp LI BIO POCTFFNUs_4FEBCCEC doc Author N A
5. Vaughan Authorised by N A Vaughan Luton and Dunstable Hospital NHS Foundation Trust CONTROLLED LI BIO POCTFFNUs Clinical Biochemistry Edition Number 1 0 Page 5 of 17 PRINTED COPIES UNCONTROLLED UNLESS MARKED CONTROLLED IN RED 0 INTRODUCTION 0 1 Purpose and Scope This document describes the procedure for measuring fetal fibronectin using the Rapid fFN 10Q system in delivery suite to ensure the provision of accurate and reliable patient results for the Clinician to act upon The system measures fetal fibronectin in cervicovaginal secretions which is associated with increased risk of preterm delivery in symptomatic pregnant women between 24 weeks and 34 weeks 6 days gestation 0 2 Clinical Indication The test is used as an aid in assessing the risk of preterm delivery in the next 7 14 days in pregnant women with signs and symptoms of early preterm labour intact amniotic membranes and minimal cervical dilatation lt 3cm It can only be used in women who are between 24 weeks and 34 weeks 6 days gestation Signs and symptoms of preterm labour include uterine contractions change of vaginal discharge vaginal bleeding backache abdominal discomfort pelvic pressure and cramping Fetal fibronectin is a major component of the extracellular matrix of the amniotic sac membranes Fetal fibronectin can be detected in cervicovaginal secretions of women in the first 24 weeks of pregnancy but diminishes between 24 and 34 weeks in normal pregnancies It
6. and evaluation of other risk factors 3 4 Reviewing Previous Results Previous results can only routinely be reviewed in the patient s notes or from the Record book Results can be reprinted if necessary please contact the POCT Team on Ext 7991 if you have specific requirements and we will endeavour to assist you 3 5 Performance Criteria Precision has been assessed over 180 specimens at a level of 53ng mL and 156 ng mL The Standard Deviation was 3 2 and 12 5 respectively CVs were 5 9 and 7 5 respectively 3 6 Documentation Patient results are documented as in Section 2 8 A record of attendance at training sessions is kept by the POCT team along with self assessment of competency forms Quality Control tests are recorded in the record book also along with any maintenance errors and logs of corrective actions C Documents and Settings nasmith Local Settings Temp LI BIO POCTFFNUs_4FEBCCEC doc Author N A Vaughan Authorised by N A Vaughan Luton and Dunstable Hospital NHS Foundation Trust CONTROLLED LI BIO POCTFFNUs Clinical Biochemistry Edition Number 1 0 Page 15 of 17 PRINTED COPIES UNCONTROLLED UNLESS MARKED CONTROLLED IN RED 3 7 Audit of Results and Indication All POCT is subjected to periodic horizontal and vertical audits and spot checks 3 8 Comparability There is no laboratory method for this test The results have therefore not been compared to any other test and there is no laboratory back up in the event of analyser fai
7. electronic version are updated simultaneously Any minor amendment must be handwritten without obscuring the previous text An asterisk is written in the adjacent margin to highlight the alteration and is signed and dated by the POCT Manager Amendments requiring immediate action must be handwritten without obscuring the previous text An asterisk is written in the adjacent margin to highlight the alteration and is signed and dated by the POCT Manager Ten or less minor amendments may be recorded before a new edition is issued Major changes must result in the immediate review of the procedure Document amendment does not replace the review process C Documents and Settings nasmith Local Settings Temp LI BIO POCTFFNUs_4FEBCCEC doc Author N A Vaughan Authorised by N A Vaughan Luton and Dunstable Hospital NHS Foundation Trust CONTROLLED LI BIO POCTFFNUs Clinical Biochemistry Edition Number 1 0 Page 3 of 17 PRINTED COPIES UNCONTROLLED UNLESS MARKED CONTROLLED IN RED HAZARDS AND PRECAUTIONS For appropriate use of protective clothing please refer to LDH Infection Control Manual Substance Hazards Precaution First aid Code Cervicovaginal Danger of infection Follow standard precautions Al B C D secretions See above Dispose of in orange clinical waste bags Extraction Buffer May cause skin and Avoid contact with skin and Al B C D eye irritation eyes IQC Danger of
8. Ask yourself the following general questions Response 1 Have I attended a training session about the device in the last year Yes No 2 Have I performed a patient test under supervision by a competent Ai Yes No practitioner 3 Have I read the Standard Operating Procedure SOP for the device These can be found on the Intranet under Departments Pathology Yes No Point of Care Services 4 Do I know what infection control precautions to take when using the Yes No device 5 Do I know the circumstances when the device should not be used a f E Yes No including test interferences and limitations 6 Do I know what action to take based on the results including if the ai Yes No result is unexpected or suspicious 7 Do I know when and where to seek help or how to report an error or ae Yes No incident Ask yourself the following device specific questions 8 Do Iknow when a fetal fibronectin test is indicated Yes No 9 Do I know how to calibrate a new lot of cassettes and the importance of Yes No this being done correctly 10 Do I know how to perform the daily QC and the liquid controls and es NG what to do if the results are INVALID or FAIL i 11 Do I know how to safely dispense 200uL of the buffer on to the sample well Yes No 12 Do I know what should be recorded in the record book for every test Yes No performed C Documents and Settings nasmith Local Settings Temp LI BIO POCTFFNUs_4FEBCCEC doc A
9. Foundation Trust CONTROLLED LI BIO POCTFFNUs Clinical Biochemistry Edition Number 1 0 Page 8 of 17 PRINTED COPIES UNCONTROLLED UNLESS MARKED CONTROLLED IN RED 1 5 Retention of Clinical Material and Records The patient s results must be immediately transcribed into their notes and recorded in the record book for the analyser When the record book is full they should be kept in a secure place on Delivery Suite for the lifetime of the analyser or if required by other guidelines for the longest time period necessary 1 6 Disposal of Clinical and Non Clinical Waste Clinical and Non clinical waste must be disposed of according to the Trust Health and Safety policy Used test kits and sample collection kits must be disposed of in clinical waste 2 EXAMINATION PROCESS 2 0 Analytical Principle The test is an immunoassay for the detection of fetal fibronectin in cervicovaginal secretions It utilizes a combination of monoclonal and polyclonal antibody reagents to selectively detect fetal fibronectin The specimen is collected and then immersed into a buffer solution 0 2mL from a syringe of this solution is then dispensed onto the sample application well of the cassette The sample flows from an absorbent pad across a membrane by capillary action and interacts with the reagent antibodies some of which have coloured dye attached The analyser detects the formation of coloured lines in the result area of the cassette Specimens containing fetal f
10. Luton and Dunstable Hospital NHS Foundation Trust CONTROLLED Clinical Biochemistry LI BIO POCTFFNUs Edition Number 1 0 Page 1 of 17 PRINTED COPIES UNCONTROLLED UNLESS MARKED CONTROLLED IN RED STANDARD OPERATING PROCEDURE FOR FETAL FIBRONECTIN USING THE RAPID Ffn 10Q SYSTEM Q PULSE FILE NAME LI BIO POCFFNUs EDITION No 1 0 DATE OF ISSUE 19th April 2013 REVIEW INTERVAL 2 Years AUTHORISED BY N Vaughan SIGNATURE AUTHOR N Vaughan COPY 1 of 3 LOCATION OF COPIES 1 Master file Quality Officer Shelves 2 Point of Care Testing Shelves 3 Intranet Point of Care Services Electronic archives Document review history Review date Reviewed by Signature C Documents and Settings nasmith Local Settings Temp LI BIO POCTFFNUs_4FEBCCEC doc Author N A Vaughan Authorised by N A Vaughan Luton and Dunstable Hospital NHS Foundation Trust CONTROLLED Clinical Biochemistry LI BIO POCTFFNUs Edition Number 1 0 Page 2 of 17 PRINTED COPIES UNCONTROLLED UNLESS MARKED CONTROLLED IN RED DOCUMENT AMENDMENT FORM FOR STANDARD OPERATING PROCEDURE FOR FETAL FIBRONECTIN USING THE RAPID Ffn 10Q SYSTEM Record Filename LP BIO POCFFN Number Date Page Amendment Number Authorised by 10 The amendment must be authorised by the POCT Manager to ensure all copies including the
11. at the code be re entered This calibration code will be used for all cassettes of that lot number 5 When calibration is complete the result will be displayed on the analyser screen and a printed label stating SYSTEM CALIBRATED will be produced Press ESC to return to the main menu 6 Stick the calibration label in the fibronectin record book and document on the side of the box of cassettes that the calibration is complete 2 6 Quality Assurance Programme 2 6 1 Daily QC QCette Quality Control Device The QCette is a replica fetal fibronectin cassette containing a membrane with printed test and control lines which is read by the analyser as a method of checking the performance of the analyser It analyses a high low and negative response The QCette test aka Daily QC must be performed on every day that a fetal fibronectin test is performed It must be performed before any patients are tested on that day The test Daily QC will flash in the main menu if it is more than 24 hours since QC was last performed Additionally the record book can be interrogated to check if QC has been performed on that day Select option 3 DAILY QC from the main menu on the analyser Enter your User ID and press ENTER Enter the Qcette serial number and press ENTER Insert the QCette and press ENTER Results will be displayed in 3 minutes When analysis is complete the result will be displayed on the analyser screen and the printed label will display
12. ation Trust CONTROLLED LI BIO POCTFFNUs Clinical Biochemistry Edition Number 1 0 Page 11 of 17 PRINTED COPIES UNCONTROLLED UNLESS MARKED CONTROLLED IN RED 6 Remove one cassette from its foil pouch being careful not to touch the sample well or the reaction area When prompted insert the cassette into the analyser Push it in until it clicks and press ENTER 7 Using a1 mL syringe add carefully 0 2 mL of the QC from the transport tube to the sample well ensure there are no air bubbles and IMMEDIATELY press ENTER 8 The analyser times the 7 minute incubation of the cassette and starts the analysis When the analysis is complete the result will be displayed on the analyser screen and the printed label 9 Press ESC to return to the Main Menu 10 Remove the cassette from the analyser Results will be printed as PASS if they are successful Results of FAIL or INVALID should be repeated Contact the POCT team on Ext 7991 if you are not able to rectify this No patient testing can be carried out until a PASS is obtained The printouts from the analyser printer must be stuck into the record book and document on the cassette kit box that this has been completed Do not use control material that is cloudy or discoloured Take care to ensure the correct cap is replaced on the correct QC bottle to prevent contamination they are colour coded 2 6 3 External Quality Assessment A pilot EQA scheme is available from WEQAS for pre term labour marker
13. becuneaasaedesadesdoeasansenesaedossabyauentadsscuentadnanadahacmarteoniales 8 2 1 Limitations of Analytical Procedure vacescncsiectsiessdeensiaiatesusancerdeiveismeoiaaitsemunsraneniss 8 Dl A TS USVICE s nesin aen E E sens EE E E E A E E E 8 2 1 2 Cross reactivity sess ccuvsvavsnaavceunsivareonssinseceauns auneadennansevieeusnige touneasd aveeapioermieae aumeie tenses 8 2 1 3 WASTE Te NCES seieren icon nein anon eo eS 8 2 1 4 Specimens unsuitable for analysis ccsccssscsseccseccssscccsssseccssccsssccsensssecsseceseaceess 9 2 1 5 Safety Notices 125 22 seccienpraaysnuatenunseta men eanteacnansreabteassanensanieesaluiaicaviese ta iebteadh aenanniGauneinorasesel 9 2 2 Central Database and Connectivity ssssssessssseseeesresetsesesrtsrtssresessrssresressessresressessresees 9 2 3 EGUMEN si xs ra ees KEE E E E AR E EE AE E 9 2 5 AUP AION sssr n ioa p eai EEA EE EEEa RE Eaa IEEE RR rE 9 2 6 Quality Assurance Programme sssssseseesesseeseesseesrtsstsstesressesstesressessteseesstesesreeseesees 10 2 6 1 Daily QC QCette Quality Control Device ssssssseseessesseesresseseeseeessseessessseseese 10 2 6 2 Liquid Internal Quality Control s seseseseessesseeseessesseseessessresressessreseesseesessesseeseese 10 2 6 3 External Quality Assessment so cassadawinwasdindnakunduwsunndanwnnwwcnans 11 2 6 4 Internal ControlS sss sserssesscrssrssersessenssessenseressssorsesssesrassandrnsiasosssessnessensinseurei sses reS 11 2 1 Th Test
14. bel spool from the printer Press the form feed button on the printer s front panel to eject the remaining label stock from the printer Slide off the right side of the spool and remove the corrugated core Remove the whole spool from the printer Slide the roll of labels over the spool from right to left as illustrated below Reattach the right side of the spool and push it firmly against the label roll Make sure there is no gap between the roll and the spool The labels will feed from the bottom of the roll C Documents and Settings nasmith Local Settings Temp LI BIO POCTFFNUs_4FEBCCEC doc Author N A Vaughan Authorised by N A Vaughan Le DL a Luton and Dunstable Hospital NHS Foundation Trust CONTROLLED LI BIO POCTFFNUs Clinical Biochemistry Edition Number 1 0 Page 13 of 17 PRINTED COPIES UNCONTROLLED UNLESS MARKED CONTROLLED IN RED 7 Hold the spool of labels in one hand and use the other to feed the free end of the roll into the feed slot on the inside of the printer 8 Push the end into the slot until a slight resistance is felt Continue pushing gently The label feed motor will feed the end and carry the labels through the printer and out the exit slot The printer will stop feeding automatically at the end of the first label press the form feed button to start this again if required 9 Insert the label spool into the printer 10 Close the cover and the printer is ready to print labels 2 10 Troubleshooting Con
15. cording to Trust Information Technology Security policy The results are reported as appropriate Ward department Manager ensures Users of the equipment keep their training up to date and maintain their competency Adequate supplies of consumables are maintained Appropriate resources are available Proper records of training and competency are maintained Ensures that faulty equipment is taken out of use Notifies the POCT team if equipment is obsolete or no longer required Infection Control Nurse Safety representative ensures Performs a risk assessment for handling biological material Advises on precautions to be taken when handling biological material including spillages and safe disposal Advises on safety of products before purchase Updates COSHH details and advises on precautions to be taken when handling all material including spillage breakage and disposal Manufacturers ensure The user is kept up to date with information regarding the device and the associated products that they provide Provide training sessions for the user in order to provide competent use of the instrument Provide regular audits of the equipment Fulfil the criteria agreed in the purchasing contract or tender 0 4 References Management of In Vitro Diagnostic Medical Devices MDA Bulletin DB2002 02 PD GEN MDAIVDMg Management and Use of Point of Care Devices MDA Bulletin DB2010 02 PD GEN MDAPOCTMg LDH Point of Care Testing Po
16. ction buffer Printer labels 400 labels Catalogue no 52660 001 stored in delivery suite s clinical room 1 mL syringes stored in delivery suite s clinical room All stock must be logged on record sheets by delivery suite staff including the date of receipt lot number first use and expiry 2 5 Calibration Calibration takes the form of entering a code into the analyser for every new box of cassettes that is opened Whenever a new box of cassettes is opened the process below must be carried out Failure to do so may result in the wrong results being produced by the analyser 1 Select Option 2 SET CALIBRATION from the Main menu 2 Enter your user ID and press ENTER C Documents and Settings nasmith Local Settings Temp LI BIO POCTFFNUs_4FEBCCEC doc Author N A Vaughan Authorised by N A Vaughan Luton and Dunstable Hospital NHS Foundation Trust CONTROLLED LI BIO POCTFFNUs Clinical Biochemistry Edition Number 1 0 Page 10 of 17 PRINTED COPIES UNCONTROLLED UNLESS MARKED CONTROLLED IN RED 3 Enter the cassette lot number including all the letters and numbers When entering letters select the corresponding number and use the up or down arrows until the letter required is displayed Press ENTER when complete 4 Enter the calibration code provided on each box of cassettes This consists of 10 alpha numeric characters If the code is not entered correctly or does not match the cassette lot number entered the analyser will request th
17. d dust amp moisture free 2 1 2 Cross reactivity There are no known cross reacting interferences 2 1 3 Interferences Assay interference from the following components has NOT been excluded Semen Lubricants soaps disinfectants or creams as these may interfere with the absorption of the specimen onto the applicator or the antibody reactions Douches White and red blood cells C Documents and Settings nasmith Local Settings Temp LI BIO POCTFFNUs_4FEBCCEC doc Author N A Vaughan Authorised by N A Vaughan Luton and Dunstable Hospital NHS Foundation Trust CONTROLLED LI BIO POCTFFNUs Clinical Biochemistry Edition Number 1 0 Page 9 of 17 PRINTED COPIES UNCONTROLLED UNLESS MARKED CONTROLLED IN RED Bacteria Bilirubin 2 1 4 Specimens unsuitable for analysis Specimens will be unsuitable for analysis if They are not collected by the specimen collection kits provided There is insufficient volume for testing lt 200uL The specimen is unlabelled The specimen has not been tested within 8 hours of collection when kept at room temperature Specimens exposed to temperatures gt 25 C Bloody specimens can cause false positive or invalid results 2 1 5 Safety Notices There are no known safety notices about this equipment 2 2 Central Database and Connectivity There is no central database or connectivity for this device 2 3 Equipment The manufacturer is Hologic and the analyser is a Rapid fFN 10Q analyser The analyser
18. er 1 0 Page 4 of 17 PRINTED COPIES UNCONTROLLED UNLESS MARKED CONTROLLED IN RED TABLE OF CONTENTS 0 INTRODUCTION cresian eens pasture sx ousaedse SE E essanaince ono aencsassanedenwonesesaniin EEE 5 0 1 Purpose and SCONE cesacenh aces vwsd denen ctussousiecan canes uexonsaeddcaucnstaxseiannsenenecuaaveediteednasausxgounnesst 5 0 2 Ca Indication ositaciccesacsusesliwen ante uaxscrendaesscaneasuucesticeyenaennsloventasiatentenuntetienweasudetoneten 5 0 3 Responsibilitie S sssri aE EE E EE EE AEA EAEEREN E ATENa 5 OE RI T A E E E A E 6 0 5 Definit ONS es hteceetu noes aus eign eE ER R EE EE cea usb EE Utes EER NTER watt 6 0 0 DocumentatiON seco aidoy conc enw ipad ieeea tea sisan sees uerepveen bes vcnseanseus sai oei EEn EEE EAS Rne RaRa Ei an apies 7 I PRE EXAMINATION PROCESS srosssantersrer nresnani Eln EEEE E REEERE EK OEE 7 1 1 Patient Prepar tiOns sesiis EO E E TR 7 1 2 The Se CUNT a scseitasisnac naerercauheaae sa wnee vane suitenGiaa ex Tataren narine asnast tarna Tae asaan aaaea ressens sERsS 7 1 4 Spillage of Clinical and Non Clinical Waste 0 cccccccssccesseeeeeeeeeeseeceseeeeeeeeesseeenseenes 7 1 5 Retention of Clinical Material and Records is ccssscssicerss cosaseetssssevecseorassenvcenss toocasetis cotaca ens 8 1 6 Disposal of Clinical and Non Clinical Waste 0 cccccccecceesseeeeeeeseeeseeeeseeeseeeeseeneeeeaeenes 8 2 EXAMINATION PROCES S hppa cca aece dees man E 8 20 A alytic l Principle jscxsisdiccsavzavudsssat
19. etent users Training is the responsibility of the POCT team Ext 7991 in conjunction with the manufacturers Self competency assessment forms are available as an Appendix to this document Records of those attending training sessions and completed competency documents are kept by the POCT team 1 1 Patient Preparation Cervical disruption due to such events as sexual intercourse digital cervical examination or vaginal probe ultrasound may cause a positive fetal fibronectin result Therefore do not perform the test until 24 hours after any of these events have occurred If you are unsure whether the test is required or whether cervical disruption has occurred then collect the specimen and subsequently carry out an examination If any cervical disruption has occurred a repeat test must wait for 24 hours after this has taken place this should be determined in consultation with the patient and clinician Please note if the patient reports having had intercourse in the previous 24 hours a negative test result is valid Patients with known or suspected placental abruption placenta previa or moderate or gross vaginal bleeding should not be tested for fetal fibronectin Ruptured membranes cervical dilatation gt 3cm or cervical cerclage are also contraindications for the test The sample is collected from the cervicovaginal secretions during speculum examination The patient should therefore be prepared appropriately and a speculum inserted into the vagina
20. ibronectin react with the specific antibody fibronectin coloured conjugate and form a coloured line in one portion of the cassette membrane Absence of this coloured line suggests a negative result To serve as a positive procedural control a second coloured control line will always appear on the cassette membrane regardless of the presence or absence of fibronectin If the second line does not appear here the test is invalid The Rapid fFN 10Q analyser interprets the intensities of the test and control lines at the end of the 7 minute reaction time and produces the results 2 1 Limitations of Analytical Procedure Refer to Section 1 1 Patient Preparation Under no circumstances should glass tubes or pipettes be used in association with fetal fibronectin as fetal fibronectin binds to glass Polypropylene or polyethylene are acceptable Under no circumstances can results be read visually Do not mix materials from different kit lots or use devices beyond their expiry dates Only samples collected from the posterior fornix are suitable 2 1 1 The device The Cassette must be stored at room temperature between 15 30 C Handle cassettes with care do not touch scratch or compress membrane materials in the cassette The Analyser amp Printer must be operated at room temperature 15 30 C and between 20 80 non condensing humidity The QCette should be stored at room temperature 15 30 C and also stored in the container provided as it must be kept clean an
21. infection Follow standard precautions Al B C D May cause skin and See above Dispose of in eye irritation orange clinical waste bags Avoid contact with skin and eyes EQA Danger of infection Follow standard precautions Al B C D See above Dispose of in orange clinical waste bags PDI Sanicloth 70 Irritating to eyes Keep away from sources of A B C R36 Highly ignition No smoking flammable R11 IF IN ANY DOUBT CONSULT A SENIOR MEMBER OF STAFF OR YOUR SAFETY REPRESENTATIVE Key Al Ingestion wash mouth thoroughly with water and give plenty to drink In severe cases obtain medical attention B Eye contact irrigate thoroughly with water Seek medical help C Skin contact wash off skin thoroughly with water D Inhalation remove to fresh air If severe call a physician If First Aid treatment has to be given contact the nearest first aider but do not delay treatment to the casualty If necessary call the crash team 2222 Treat all body tissue and waste as potential infective In all cases an Incident form must be filled in and report to Occupational Health or Accident Service if out of hours See Also Risk Assessments Blood or Body Fluid Analysis 47 C Documents and Settings nasmith Local Settings Temp LI BIO POCTFFNUs_4FEBCCEC doc Author N A Vaughan Authorised by N A Vaughan Luton and Dunstable Hospital NHS Foundation Trust CONTROLLED LI BIO POCTFFNUs Clinical Biochemistry Edition Numb
22. is located in the Delivery Suite clinical room 2 4 Reagents Consumables All supplies are from Hologic UK Limited and are ordered by delivery suite staff as required Fetal Fibronectin Cassettes Box of 26 Catalogue no PRD 01018 stored in delivery suite clinical room the shelf life is 18 months from manufacture Unopened cassettes may be used until the expiration date printed on the foil pouch and the box containing the pouched cassettes Once the foil pouch is opened the cassette should be used immediately Store at room temperature 15 30 C Fetal Fibronectin Control Kit Catalogue no PRD 01019 stored in delivery suite s unlocked fridge the shelf life is one year from manufacture Unopened controls may be used until the expiration date printed on the bottle Once opened they should be used within 6 months However controls should not be used if they are cloudy or discoloured Store in a refrigerator from 2 8 C Avoid cross contamination of reagents recap controls tightly with the correct colour coded caps Handle controls as if potentially infectious Allow to come to room temperature and invert to mix before testing Rapid fFN 10Q QCette Catalogue no PRD 01021 stored in delivery suite s locked drug cupboard store at room temperature 15 30 C in the container provided Rapid fFN Specimen Collection kit Catalogue no PRD 01020 stored in delivery suite s clinical room Contains 25 sterile swabs and 25 tubes containing the extra
23. licy MP GEN LDHPOCTPo LDH Infection Control Policy MI GEN LDHInfCrl LDH Health and Safety Policy MP GEN LDHH amp SPol LDH Waste Management Policy MP GEN LDHWsMgP LDH Information Technology Security Policy MP GEN LDHIM amp TPO 0 5 Definitions User Any person who handles the device whether it is used directly to produce results or indirectly for maintenance and Quality Assurance Procedures This includes Clinicians Nursing Staff Healthcare Scientists and Medical Equipment Technicians as necessary EQAS External Quality Assessment Scheme C Documents and Settings nasmith Local Settings Temp LI BIO POCTFFNUs_4FEBCCEC doc Author N A Vaughan Authorised by N A Vaughan Luton and Dunstable Hospital NHS Foundation Trust CONTROLLED LI BIO POCTFFNUs Clinical Biochemistry Edition Number 1 0 Page 7 of 17 PRINTED COPIES UNCONTROLLED UNLESS MARKED CONTROLLED IN RED POCT Point of Care Testing SOP Standard Operating Procedure IQC Internal Quality Control MHRA Medicines and Healthcare Products Regulatory Agency 0 6 Related Documents e In House Health and Safety Policy MP GEN H amp SMan Spillage Decontamination and Waste Disposal Procedures MI GEN SpIDcenWst LDH Use of Fetal Fibronectin Test for Preterm Labour CG321 Rapid fFN 10Q System Quick Reference Guide Fetal Fibronectin Record Book 1 PRE EXAMINATION PROCESS 1 0 Training amp Competency Fetal fibronectin testing should only be carried out by trained and comp
24. lure C Documents and Settings nasmith Local Settings Temp LI BIO POCTFFNUs_4FEBCCEC doc Author N A Vaughan Authorised by N A Vaughan Luton and Dunstable Hospital NHS Foundation Trust CONTROLLED LI BIO POCTFFNUs Clinical Biochemistry Edition Number 1 0 Page 16 of 17 PRINTED COPIES UNCONTROLLED UNLESS MARKED CONTROLLED IN RED 4 SELF ASSESSMENT COMPETENCY FORM POCT Annual Self Assessment Competency Statement for Fetal Fibronectin Testing using Rapid fFN 10Q Analyser Do not use this device unless you are competent to do so DPUMIAMISS oi viebvessuduisetdveaienddheadces PORCH AME S Soupeauniaes exes siaukevaceeswed Dept Ward dsisspanksasexgssicauetecesiatens Job Title sisstccaxtesseaeseusaseieranzucases Self verification of competence is undertaken by assessment against the statements below These statements are designed to help you assess your competency to use this POCT Point of Care testing equipment Responsibility for safe use remains with you so if you are in any doubt regarding your competence to use the device you should seek guidance You must be able to answer yes to all the questions before considering yourself competent and completing the competency statement in section B overleaf If you are in any doubt or feel that you are not competent please complete section A over leaf and contact the POCT team Ext 7991 or your manager to instigate further learning or training
25. ng sample in the transport tube if possible If INVALID is still obtained contact the POCT team on Ext 7991 for advice 3 3 Interpretative Comments Among symptomatic women elevated levels gt 50ng mL or POSITIVE of fibronectin between 24 weeks 0 days and 34 weeks 6 days indicate increased risk of delivery in lt 7 days or lt 14 days from sample collection Negative results 124 out of 125 women will not deliver within the next 14 days i e negative predictive value of 99 2 C Documents and Settings nasmith Local Settings Temp LI BIO POCTFFNUs_4FEBCCEC doc Author N A Vaughan Authorised by N A Vaughan Luton and Dunstable Hospital NHS Foundation Trust CONTROLLED LI BIO POCTFFNUs Clinical Biochemistry Edition Number 1 0 Page 14 of 17 PRINTED COPIES UNCONTROLLED UNLESS MARKED CONTROLLED IN RED The patient can be discharged unless there are other reasons for admission apart from preterm labour There is no need for tocolysis There is no need for steroids Provide reassurance Educate the patient on signs and symptoms of preterm labour and advise the patient to return if the situation becomes worse Clinical judgement must always be part of the assessment in the presence of a negative test when there is still a high index of suspicion discuss the case with the consultant on call Ifthe patient is symptomatic with negative fibronectin test the test can be repeated after 24 hours if the symptoms change Positive res
26. rst three characters should be displayed on the screen ensure they match the first three of the cassette lot number If they do not refer to Section 2 5 Calibration Enter the remaining 2 numbers of the lot number and press ENTER 8 Enter the patient ID and press ENTER 9 Remove one cassette from the foil pouch being careful not to touch the sample well or the reaction area When prompted insert the cassette into the analyser Push it in until it clicks and press ENTER C Documents and Settings nasmith Local Settings Temp LI BIO POCTFFNUs_4FEBCCEC doc Author N A Vaughan Authorised by N A Vaughan 0S uN rE Luton and Dunstable Hospital NHS Foundation Trust CONTROLLED LI BIO POCTFFNUs Clinical Biochemistry Edition Number 1 0 Page 12 of 17 PRINTED COPIES UNCONTROLLED UNLESS MARKED CONTROLLED IN RED 10 Using a 1 mL syringe add 0 2 mL of patient sample from the transport tube to the sample well being careful that there are no air bubbles and IMMEDIATELY press ENTER 11 The analyser times the 7 minute incubation of the cassette and starts the analysis When the analysis is complete the result will be displayed on the analyser screen and the printed label 12 Press ESC to return to the Main Menu 13 Remove the cassette from the analyser and dispose in orange clinical waste bins 2 8 Results A result is available after 7 minutes The results must be recorded with the following information A Details that are on the print o
27. s 2 specimens are sent on a monthly basis and must be analysed within 24 hours of receipt They must be stored in the fridge until they are ready to be analysed and then warmed to room temperature before they are tested Take care over the two samples and ensure you correctly identify specimen 1 and specimen 2 and enter this clearly into the analyser e g PTL1 1 and PTL1 2 Print two copies of the results one for the record book and one to stick on the paperwork received with the specimens Return the paperwork to the POCT team in Clinical Biochemistry after the tests are completed 2 6 4 Internal Controls Internal controls are performed automatically with every test These check for 1 A threshold level of signal at the procedural control position 2 Proper sample flow across the Rapid fFN 10Q cassette 3 Absence of conjugate aggregation Cassette QC Pass Fail 4 Proper function of analyser hardware Analyser QC Pass Fail 2 7 The Test Procedure 1 Ensure the daily IQC QCette test has been successfully completed 2 Gently mix the specimen transport tube specimen should be at room temperature Open the tube and express as much liquid as possible from the applicator by rolling the tip against the inside of the tube Dispose of the applicator as hazardous waste in a orange clinical waste Select TEST PATIENT from the Main menu Enter User ID and Press ENTER Enter the cassette lot number printed on the foil pouch of the cassettes The fi
28. s detection between 24 and 34 weeks gestation is associated with preterm delivery Testing for fetal fibronectin should reduce unnecessary admissions use of steroids and tocolytics among women with negative test results 0 3 Responsibilities POCT Management group ensure The responsibilities authority and interrelationships of all personnel involved in POCT are specified and communicated within the organisation Staff performing POCT receive appropriate training supervision and competence testing The selection of POCT devices and systems includes their practicability and the comparability of their results with those obtained in the laboratory The reports of the POCT quality assurance programme s are reviewed by the group and advice on improvement is provided and implemented Senior Clinical Biochemistry Management Staff ensure Departmental policies and procedures are in accord with the requirements of the MHRA bulletins Trust Medical Device Management Policy and Pathology Accreditation CPA UK Ltd standards and any other quality standards to which the organisation subscribes The needs and requirements of the users are reviewed regularly Persistent problems are escalated to the relevant manufacturer and actioned Determining and documenting back up plans if equipment is out of action however please note that there is no back up service for measurement of fibronectin Clinical Biochemistry Staff with POCT responsibilities ensure
29. tact the POCT team on Ext 7991 should you need further support There is no laboratory back up for this test as the laboratory does not perform this test in house The POCT Team have access to the user manual and can provide troubleshooting advice In the event of a problem that can not be solved the POCT team or Senior Midwife if necessary can contact the manufacturer on 0800 032 3318 for specialist technical advice This number is on a sticker on the analyser The technical advice line will try to fix any problems over the phone if this is not possible our local representative will be asked to attend the site and can swap out the analyser with a replacement if it can not be fixed As there is no formal service contract with the manufacturer they cannot guarantee a fixed response time 3 POST EXAMINATION PROCESS 3 1 Reference Values Results will be POSITIVE NEGATIVE or INVALID A normal result is NEGATIVE A quantitative result in ng mL is also displayed Results gt 50ng mL are positive and lt 50ng mL are negative 3 2 Reporting the Results The clinical team looking after the patient are responsible for the results obtained by POCT and any therapeutic decision based on a POCT result They person performing the test should immediately inform the requesting doctor of any unexpected or clinically significant abnormal results and ensure the results are documented as above If an INVALID result is obtained repeat the test using the remaini
30. ults 1 in 6 women will deliver within 14 days positive predictive value 16 7 Manage according to the preterm labour protocol consider Hospitalisation Corticosteroids Tocolytics Antibiotics if documented infection Consider need for in utero transfer if NICU closed or no beds available The neonatal registrar or consultant should counsel the woman and partner about consequences of pre term birth Ifthe woman remains undelivered but the clinical situation still indicates a risk of preterm delivery after 7 days the obstetric consultant may decide to repeat a fibronectin test to guide further management Multiple pregnancies Fibronectin testing can be used in assessment of multiple pregnancies with threatened pre term labour management will be individualised by the consultant Further information The fibronectin result should not be interpreted as absolute evidence for the presence or absence of a process that will result in delivery in less than 7 14days in symptomatic women A positive result may be observed for patients who have experience cervical disruption This may be caused by but not limited to sexual intercourse digital cervical examination or vaginal probe ultrasound The fibronectin result should always be used in conjunction with information available from the clinical evaluation of the patient and other diagnostic procedures such as cervical examination cervical microbiological culture assessment of uterine activity
31. ut from the analyser Date Time Calibration code Lot number of cassettes Quality control result where appropriate Patient s hospital number or NHS number Patient s result B Details that are NOT on the printout and must be written into the record book Patient s first and last names in full Comments action taken User s signature Printed name of user This record book must be kept beside the analyser Details of maintenance faults and corrective action should also be noted in this record book 2 9 Maintenance 2 9 1 As required Clean up any small spills or splashes immediately using a PDI sanicloth 70 If the analyser needs to cleaned it must be turned off first Never use cleaning agents in a spray to clean the analyser 2 9 2 Weekly The analyser and surrounding area must be kept clean from spillages and should be cleaned on a weekly basis This should be noted in the record book Turn the analyser off prior to cleaning Use a PDI sanicloth 70 to clean the device and surrounding area Never use cleaning agents in a spray to clean the analyser 2 9 3 Changing the printer labels When the printer is out of labels the power light will flash 1 Leave the printer turned on and open the cover The last label on the roll may be connected to the corrugated core by a piece of tape If it is use scissors to cut the label between the roll and the label between the roll and the label feed slot Remove the la
32. uthor N A Vaughan Authorised by N A Vaughan Luton and Dunstable Hospital NHS Foundation Trust CONTROLLED LI BIO POCTFFNUs Clinical Biochemistry Edition Number 1 0 Page 17 of 17 PRINTED COPIES UNCONTROLLED UNLESS MARKED CONTROLLED IN RED POCT Annual Self Assessment Competency Statement for Fetal Fibronectin Testing using Rapid fFN 10Q Analyser U lt Rapid IFN for the TLIIQ System D Do not use this device unless you are competent to do so Surname oss vecin da veve cebnewse seen teeeins Forename s 445422 caistinsadscosacsevsadens Dept Ward c xcitacacesensaaiecsderiesn Job Title sciciecpavtatig igs pywacsaenecsuesiins Complete either Section A or B whichever is appropriate to you Section A I require further training before I can use the Rapid fFN 10Q analyser for fetal fibronectin in a competent manner Section B I certify that I am aware of my responsibility for continuing professional development and I understand that I am accountable for my actions With this in mind I make the following statement I am competent to use the Rapid fFN 10Q POCT analyser for fetal fibronectin analysis Please return this form to the POCT team Clinical Biochemistry L amp D Telephone Ext 7991 We suggest you also keep a copy for your personal records C Documents and Settings nasmith Local Settings Temp LI BIO POCTFFNUs_4FEBCCEC doc Author N A Vaughan Authorised by N A Vaughan
Download Pdf Manuals
Related Search