Presentation on theme: "Overview of Syphilis Rapid Syphilis Testing:"— Presentation transcript:
1Overview of Syphilis Rapid Syphilis Testing: Workshop for the Training of HCW[Enter date, location of workshop]
2Learning Objectives By the end of this module, participants should: Understand of the global epidemiology of syphilis and congenital syphilisDescribe the stages of syphilis infectionClinically identify the signs of infectionUnderstand syphilis transmission and the risk during pregnancy
3Overview of Syphilis Syphilis is a sexually transmitted infection Caused by a bacteria, Treponema pallidumInitial infection causes a genital ulcerationRaised painless lesionGenital ulcer disease can be caused by other organisms as wellHerpes simplex, Haemophilis ducreyi (chancroid)
4Epidemiology Syphilis is a major public health problem An estimated 12 million new cases of syphilis occur worldwide each yearThe majority of infections occur in the developing world including Latin-America, sub-Saharan Africa and Southeast AsiaUntreated syphilis in pregnancy is associated with spontaneous abortion, stillbirth, perinatal death, premature delivery, low birth weight, or congenital syphilis
5WHO estimates 12 million new cases of syphilis occur worldwide each year 100,000140,000100,000240,000370,0004 M3 M4 M10,000
6Syphilis PrevalenceIn [Sub-Saharan Africa/ Latin America/ South-East Asia], the prevalence of syphilis infection ranges from [lowest estimate]-[highest estimate]%In [Enter name of country], the prevalence of syphilis is [enter national prevalence]%
7Modes of Transmission Syphilis is transmitted through Contact with the genital ulcerMother to child (vertical transmission) during pregnancyBlood transfusion
8Clinical Presentation Syphilis presents in multiple stagesPrimary, secondary, early latent, late latent and tertiaryPrimary syphilis presents as a painless ulcerMainly on external genitals, vagina, anus, or rectumIn women, the ulcer may be deep in the vagina and go unnoticedCan also be on fingers, lips, or mouth
9Primary SyphilisPrimary syphilis occurs 3 weeks after infection (9-90 days)Primary syphilis is characterized by a painless, indurated ulcer (or chancre)After 1-5 weeks, the ulcer spontaneously resolves without treatmentThis stage is highly infectious
10Secondary syphilisThe bacteria have spread to all organs and body fluidsSymptoms develop 1-5 weeks after the ulcerCharacterized by a generalized rashSymptoms spontaneously resolve after 2-6 weeksThis stage is also highly infectious
11Early Latent Syphilis Asymptomatic Occurs <1 after infection Less infectious than primary and secondary syphilisVertical transmission can still occur
12Late latent syphilisOccurs 2 years after initial infection and may last the patient’s lifetimeAsymptomaticLower risk of transmission during this stage than earlier stages of infection
13Tertiary SyphilisOccurs anytime after secondary syphilis and may not occur at allResult of widespread infection during secondary syphilisSymptoms include gumma (lesions) of the skin, muscles, eyes, bonesAlso includes cardiovascular syphilis and neurosyphilis
14Congenital Syphilis Causes stillbith, miscarriage, and preterm labour Babies born to syphilis positive mothers may have low-birthweight, abnormal liver or spleen development, anemia, jaundice, lesions on the palms and soles, or neurological problemsOnly half of newborns infected with syphilis can be clinically identified at birth
15Infectivity of Syphilis 1° > 2° > Early Latent > Late Latent & 3°Primary UlcerRash on palms & solesAsymptomatic, <2 yearsAsymptomatic, >2 yearsGumma, Neurosyphilis, Cardiovascular syphilis
17ConclusionsSyphilis is a major health concern and causes stillbirth, low-birthweight babies and congenital syphilisSyphilis is transmitted through contact with a genital ulcer, through sexual intercourse, vertically from mother to baby during pregnancy or through blood transfusionsSyphilis has multiple stages
18Questions for Participants Have you ever seen a case of syphilis?Was it primary, secondary or tertiary syphilis?Have you ever seen a baby with congenital syphilis?
19ReferencesWHO. The elimination of congenital syphilis: Rationale and strategy for action Accessed January 24, 2008Aiken CG. The causes of perinatal mortality in Bulawayo, Zimbabwe. Central African Journal of Medicine 1992; 38:
20Syphilis Testing Technologies Rapid Syphilis Testing:Workshop for the Training of HCW[Enter date, location of workshop]
21Learning ObjectivesBy the end of this module, participants should be able to:Describe the difference between a test that detects bacteria and a test that detects antibodies.Understand the definitions of antigen and antibody.Describe the main characteristics of treponemal and non-treponemal tests.Describe the characteristics and benefits of rapid diagnostic tests.
22Syphilis diagnosticsDiagnosis of syphilis infection is based on detection of:Treponema pallidum bacteriaAntibodies
23Detection of Bacteria The following diagnostic tests diagnose syphilis infection based on the detection of theTreponema pallidum bacteria:MicroscopyDark fieldFluorescent
24The Immune Response Antigen (Ag) Antibody (Ab) Is a substance recognized by the body or immune system as foreignIt may be the whole organism or part of it (protein, lipids, ect.)An antibody is produced by the immune system in response to the detection of an antigenAntibody (Ab)A protein produced in response to an AgThe antibody will attack the Ag as part of the immune response
25Syphilis Antibody Response Two types of antibodies are produced during asyphilis infectionTreponemal AntibodiesThese are produced against an Ag specific to syphilisNon-treponemal AntibodiesThese are produced against a non-specific Ag, reagin/ cardiolipinReagin/ Cardiolipin is also produced when tissue is damaged during infection (Tb, malaria), auto-immune conditions (rheumatoid arthritis) or pregnancy
26Syphilis Antibody Response Clinicalstages ofsyphilisprimarylesionsecondarylatenttertiary*IgM – ELISA or FTA-ABS 19S or immunoblot100%80%60%40%20%FTA-AbsIgM*treatedTPHAuntreatedVDRL /RPRTime (weeks)time (years)
27Detection of the Antibody Serological tests for syphilis diagnosis detect either the treponemal or non-treponemal AbTreponemal tests detect the antibody specific to syphilisNon-treponemal tests detect the reagin/ cardiolipin antibody that is produced during syphilis infection but is not specific to syphilis
29Treponemal Tests Detect antibodies specific to T. pallidum antigens They become positive early in infectionCan be used to:Confirm a clinical diagnosis, ORConfirm positive result for non-treponemal testRemain positive for many years, even after successful treatmentDetect life-time syphilis exposure
30This image shows the reactivity (positivity) of Treponemal Serological tests by stage of syphilis infection and the influence of successful treatment. Note that once positive, most individuals will remain positive for their lifetime despite successful treatment. This is important for HCW because it means that a positive rapid test may mean that an individual has a current active infection, a past infection that was not-treated or a past infection that was successfully treated. It is also possible that if the past infection was correctly treated, the person has become infected again. Because the risk of harm to a baby is so great and 50% of women infected with syphilis will have a stillbirth, miscarriage, lowbirthweight baby, or baby born with congenital syphilis, it is important to treat all pregnant women with a positive test result.
31Treponemal Tests Most are limited to research laboratories POC tests are the exceptionSamples have to be transported to established labsResults are not available for several days or weeksIndividuals may not return for resultsResources are wastedPositive may not be treated leading to adverse pregnancy outcomes or onward transmission
32How to Perform TPPA/ TPHA Add sample diluent to wells 1-4Add serum sample to well number 1Mix and transfer to well number 2Repeat this process to well number 4Mix and discard same volume transferred from well 3Add unsensitized RBCs/ Gelatin particles to well number 3Add sensitized particles/ RBs to well 4Read results in a light box after incubationIt is not necessary for participants to have a strong understanding of the process for performing TPPA/ TPHA. The important point to convey is that these tests are complicated, required highly skilled and well trained laboratory technicians and expensive equipment. They must be performed in a laboratory and are not suitable for district health care facilities.
33This is an image of the plate on which TPPA/TPHA would be performed and the wells to which sample and reagents would be added
35Simple Treponemal Tests Rapid Syphilis Tests (RST):Are simple to performCan be used at primary health centres, at the point of careGive results in less than 30 minutesUse whole blood, collected from a finger prickEnable treatment to be give the same day as testingPoint of Care means that a test can be brought to the patient and used during a consultation at a HCW’s desk, a lab testing bench or even a patient’s bedside.
36Simple Treponemal Tests Like all treponemal tests, RSTs:Detect antibodies specific to T. pallidumCan be used early to detect infectionRemain positive even after successful treatment
37Simple Treponemal Tests Important for control programmesUse whole blood, serum or plasmaCan be integrated into other programmes (VCT, PMTCT, STD, ANC)Have high sensitivity (85-98%)This is a measure of the ability of a test to detect infectionHave high specificity (93-98%)This is a measure of the ability of a test to exclude infectionSensitivity is the proportion of people with syphilis infection that are correctly diagnosed as being positive by the test.Specificity is the proportion of people without syphilis infection that are correctly diagnosed as being negative by the test.
39Performing RSTFollow the manufacturer’s instructions or a national SOPSOP or Standard Operating Procedure provides detailed instructions on how to perform the testNOTE: Written SOPs should always be available at each testing site, and must always be followed when performing testingAfter HCW have performed a test several times, often they stop referring to the SOP. This can lead to bad habits forming which may effect the quality of testing leading to incorrect results. Reinforce that it is very important to always refer to the SOP when performing testing. This will help prevent bad habits from developing and help the HCW to be confident in the result they are providing to the client/ patient.
40RST ProcedurePrepare the testing area and put on gloves and gown/ apronRemove the test cassette from the foil pouchPlace it on a flat surface and label it with the client/ patient numberAdd patient specimen (serum/ whole blood/ plasma) to sample well SAdd diluent buffer to sample well SRead the results after the specified timeEnter results on record form/ registerDispose of all materials in biohazard waste/ sharps containerRemind participants that this is a brief overview of the testing procedure. The SOP will be read and reviewed before testing and will be present during the practical sessions when participants will practice performing the test. The SOP will contain the details regarding the volume of patient specimen and buffer and the specified time.
41Advantages of Rapid Tests Do not require equipmentSimple and rapidUse whole blood, serum or plasmaRequire minimal technical skillsCan be performed at the Point of Care (POC)Increase access to testingIncrease coverage of testing and treatmentResults are easy to interpret
42RPR (non-treponemal test) Rapid Syphilis Test (treponemal test) RPR vs. Rapid TestsRPR (non-treponemal test)Rapid Syphilis Test (treponemal test)Can be used to distinguish active from past treated infectionCannot distinguish active infection from past treated infectionTest of cureMeasures lifetime exposure to syphilisSerum/ plasmaWhole blood/ serum/ plasmaNeeds laboratory facility & trained personnelCan be done in primary health care settingsTest only takes 8 minutes but patients often need to return for results and treatmentResults in less than 30 minutes and treatment can be given at the same visitInterpretation of results requires a high degree of training and experienceResults are simple to interpretReagent needs refrigerationTest and reagents can be transported and stored at room temperatureFalse negative results due to prozone effect and biological false positivesNo prozone effect or biological false positivesNon-treponemal antibodies decline after successful treatment. This means that RPR can be used to determine if a person with a treponemal positive test (eg. RST, TPPA, TPHA) has an active infection or a past treated infection. There are some people, called sero-fast, whose non-treponemal (reagin/ cardiolipin) antibodies do not decline after successful treatment. This occurs in approximately 15% of people.RPR only takes 8 minutes to perform but often times a facility does not have a centrifuge to separate blood and will have to wait for it to separate. Also, in low-volume facilities, HCW or laboratory technicians may wait until they have several samples to test (one RPR test can be used for several samples). If a facility does not have a shaker, HCW or laboratory technicians may have to shake the card by hand for 8 minutes. This is time consuming and if done incorrectly, or if the results are not interpreted by a well-trained and experienced individual, there may be incorrect results given to patients.Biological false positives are individuals who have the cardiolipin/ reagin antibody in their blood and so have a positive RPR result. They are biological false positives because even though the antibody was present, it is not because of syphilis infection but because of another infection/ autimmune condition that causes tissue damage. Treponemal antibodies are only produced in response to syphilis infection so rapid syphilis tests (like all treponemal tests) do not have biological false positives.
43Interpretation of RST Results Unable to distinguish between active infection and past treated infectionA positive RST result indicates the client/ patient has been exposed to syphilis during their lifetime[REFER TO NATIONAL GUIDELINES FOR FURTHER GUIDANCE ON CONFIRMATORY TESTING, TESTING ALGORITHMS, AND TREATMENT STRATEGIES]The inability of rapid tests, or any treponemal test, to distinguish between current active and past treated infection may lead to overtreatment. It is important to remind HCW that with only a RST, it is impossible to know if past treatment was successful or if re-infection has occured. Even if RPR was available as a confirmatory test, it would be difficult to know if treatment was successful because 15% of people are serofast which means that their non-treponemal (reagin/ cardiolipin) antibody levels do not fall. Remind HCW and workshop participants that because the risk of transmission to the baby and adverse outcome (stillbirth, miscarriage, lowbirthweight, congenital syphilis) are so severe, it is better to treat all RST positive pregnant women than to risk a baby’s life.REFER TO NATIONAL GUIDELINES FOR INFORMATION ON TESTING ALGORITHMS, CONFIRMATORY TESTS, AND TREATMENT
44Syphilis: Proposed Testing Algorithms No RPR testing available:RPR testing available:positivenegativetreatBloodRDT+-/-BloodRDT+-negativeRPRpositiveRe-test in 6 wkstreatTHIS IS ONLY INTENDED AS AN EXAMPLE.REFER TO NATIONAL GUIDELINES FOR COUNTRY-SPECIFIC TESTING ALGORITHMS.
45Non-Treponemal TestsT.pallidum infection produces non-specific antibodies (non-treponemal antibodies)These are detected by non-treponemal tests (RPR, VDRL)Non-treponemal (reagin/ cardiolipin) antibodies arise from:Lipoidal antigens that are the same on bacterial cells and host cells
46Types of Non-treponemal Tests FlocculationAntigen-antibody complexAg-Ab complex remains suspended (visible)Ex. RPR, VDRL, TRUSTComplement Fixation TestWasserman reaction test
47Rapid Plasma Reagin (RPR) Relatively simpleRequires equipment and skill to perform and interpret resultsResults are subjectiveLess sensitive than Treponemal tests in early syphilis infectionTend to be negative during late syphilisAfter successful treatment, becomes negative (Test of Cure)Prozone effect causes false negativesOther infections cause biological false positivesRPR does not give a definitive yes/ no answer. The results have to be interpreted which requires a high level of skill and training.RPR can be used as a test of cure but 15% of people are “sero-fast” which means that their antibody levels do not decline despite successful rounds of treatment.The prozone effect occurs when an individual is positive and has very high levels of antibody circulating in the bloodstream. The high level of antibodies interfere with the proper formation of the antigen:antibody lattice network which is necessary to visualize a positive flocculation test.Other infections that cause the body to produce reagin/ cardiolipin antibody include Tb and malaria. Autoimmune reactions like rheumatoid arthritis, and pregnancy may also cause the production of reagin/ cardiolipin antibodies. These antibodies are the same as those produced during a syphilis infection and result in a positive RPR result. It is called a biological false positive because the test is truly positive but it is positive for a reason that is not a syphilis infection which is what RPR is designed to diagnose.
50Non-treponemal TestsDetect non-specific antibodies formed during syphilis infectionExamples:Rapid Plasma Reagin (RPR)Venereal Disease Research Laboratory (VDRL)
51Use of Diagnostic Tools for the Prevention and Control of Syphilis RPR Rapid TPHA EIADiagnosis *Screening * /Tx efficacyRe-infection?Surveillance* can be used with whole blood
52Non-treponemal TestsDetect non-specific antibodies formed during syphilis infectioncardio-lipin antigeneg. Rapid Plasma Reagin (RPR)eg. Venereal Disease Research Laboratory (VDRL)
53Questions for Participants Have you ever performed a syphilis test and if so, which one?Was it a treponemal or non-treponemal test?How user-friendly do you think it was?
54Treatment of Syphilis Rapid Syphilis Testing: Workshop for the Training of HCW[Enter date, location of workshop]
55Learning Objectives By the end of this module, participants should be able to:Describe the recommended and alternative treatment and dosage for an adult with syphilis infectionDescribe how to manage an infant born to a mother who tested positive for syphilis during pregnancyDescribe how to manage the partner of a syphilis positive individualDescribe the potential reactions to the recommended and alternative treatment for syphilisDescribe the potential risks and adverse outcomes if treatment is not administered
56When Do You Treat A Patient? If a pregnant woman tests positive for syphilisIf a patient at the STI clinic tests positive for syphilisIf a patient at the delivery ward tests positive for syphilisNOTE THIS IS AN EXAMPLE. THE ALGORITHM WILL NEED TO BE ADJUSTED TO CONFORM WITH NATIONAL GUIDELINES FOR THE MANAGEMENT OF SYPHILIS
57When Do You Treat A patient NOTE THIS IS AN EXAMPLE. THE ALGORITHM WILL NEED TO BE ADJUSTED TO CONFORM WITH NATIONAL GUIDELINES FOR THE MANAGEMENT OF SYPHILIS
58How To Treat SyphilisBefore treating a patient, it is important to provide them with counselingExplain what a positive result means and the risk of transmission to a partner or babyExplain the treatment options available and that syphilis is a curable diseaseObtain consent from the patient
59Counseling REVIEW Pre-test information HELP the patient understand the meaning of the resultA positive result means you are infected with syphilisSyphilis can be cured with antibioticsSyphilis infection can harm your unborn babyDISCUSS any immediate concerns and ANSWER any questionsHaving syphilis once does not mean you will not get it againYou can still be re-infected after successful treatmentYou should not have sex until the syphilis sores are completely healed
60CounselingENCOURAGE safer sex practices in preventing reinfection and/or transmissionUse condomsHave long-term relationships where neither of you have other partnersLimit your sex partnersADVISE on telling partnersYou should tell all your sexual partners that your are positive for syphilis and that they should go to a health clinic to be tested and treated [REFER TO NATIONAL GUIDELINES]FOLLOW-UP ServicesYou should be tested for HIV infectionYou should come in to be tested again in XXX weeks [REFER TO NATIONAL GUIDELINES]You should have regular STI check-upsRefer to National Guidelines for country-specific information on partner management.Refer to National Guidelines for country-specific information on re-testing or confirmatory testing in syphilis infection
63How To Treat SyphilisThe National Guidelines recommended treatment for an adult testing positive for syphilis is:[All patients with a positive test result should be treated regardless of treatment history in a previous pregnancy]IMPORTANT: Treatment should be given on the SAME DAY as TestingREFER TO NATIONAL GUIDELINES FOR RECOCMENDED TREATMENT FOR ADULTS AND PREGNANT WOMEN.REFER TO NATIONAL GUIDELINES FOR RECOMMENDED ACTION FOR TREATING PREGNANT WOMEN WITH A POSITIVE TEST RESULT AND HISTORY OF PAST INFECTION
64How to Manage Partners[REFER TO NATIONAL GUIDELINES FOR PARTNER MANAGEMENT]DETAIL IF THE PARTNER IS TO BE TESTED AND TREATED ONLY IF POSITIVE, OR PRESUMPTIVELY TREATED AS A CONTACT WITHOUT TESTINGRefer to National Guidelines and Up-date this slide to reflect the country-specific policy for partner management.
65How To Treat SyphilisREFER TO NATIONAL GUIDELINES FOR ALTERNATIVE TREATMENT REGIMENS IF A PATIENT IS ALLERGIC TO PENICILLINDETAIL THE MEDICATION, DOSAGE, AND DURATION OF THE ALTERNATIVE TREATMENT REGIMEN AND METHOD OF ADMINISTRATION (ORAL, IV, INJECTION)Refer to National Guidelines and Up-date this slide to reflect the country-specific policy for treating patients allergic to penicillin.
66How To Treat SyphilisInfants born to mothers who tested positive for syphilis during pregnancy need to be treated according to the National GuidelinesREFER TO NATIONAL GUIDELINESDESCRIBE THE MEDICATION, DOSAGE, DURATION OF REGIMEN, AND ADMINISTRATION (ORAL, IV, INJECTION)DESCRIBE THE ALTERNATIVE MEDICATION, DOSAGE, DURATION OF REGIMEN, AND ADMINISTRATION (ORAL, IV, INJECTION)Refer to National Guidelines and Up-date this slide to reflect the country-specific policy for how to manage infants born to women who tested positive for syphilis during pregnancy.
67Infants with Congenital Syphilis Infants born with the signs and symptoms of Congenital Syphilis need to be treated according to the National GuidelinesDESCRIBE THE MEDICATION, DOSAGE, DURATION OF REGIMEN, AND ADMINISTRATION (ORAL, IV, INJECTION)DESCRIBE THE ALTERNATIVE MEDICATION, DOSAGE, DURATION OF REGIMEN, AND ADMINISTRATION (ORAL, IV, INJECTION)Refer to National Guidelines and Up-date this slide to reflect the country-specific policy for managing infants born with congenital syphilis.
68Syphilis Treatment Age Group Recommended regimen Alternative regimen RemarksAdult syphilisAdults (including pregnant women)Congenital syphilisInfants born to mothers who tested positive for syphilisInfants with signs and symptoms of congenital syphilisThis table needs to be completed in accordance with National Guidelines.
69Penicillin Allergy: Anaphylactic Shock All patients must be asked for a history of allergy to penicillinClinical Features: sudden collapse, hypotension, excessive sweating, thin pulseDifferential Diagnosis: other causes of shock, including bleeding and severe dehydration
70Management of Anaphylactic Shock Determine and remove the causeKeep the patient warmSecure the airwayRestore the BPlay the patient flat and raise his/her feetREFER TO NATIONAL GUIDELINES FOR FURTHER INFORMATIONRefer to National Guidelines and Up-date this slide to reflect the country-specific policy for managing anaphylactic shock.
71Management of Anaphylactic Shock REFER TO NATIONAL GUIDELINESDESCRIBE THE MEDICATION, DOSAGE, DURATION OF REGIMEN, AND ADMINISTRATION (ORAL, IV, INJECTION)DESCRIBE THE ALTERNATIVE MEDICATION, DOSAGE, DURATION OF REGIMEN, AND ADMINISTRATION (ORAL, IV, INJECTION)Refer to National Guidelines and Up-date this slide to reflect the country-specific policy for managing patient’s with anaphylactic shock.
72Questions for Participants Have you ever had to treat anaphylactic shock? Can you describe how you identified it? How did you manage it? What was the outcome?In your experience, how do people react to hearing that they have syphilis?
73Integration of Services Rapid Syphilis Testing:Workshop for the Training of HCW[Enter date, location of workshop]
74Learning Objectives At the end of this module, participants should be able to:Describe the current patient flow at their clinicDescribe when and where rapid syphilis testing would take placeProvide three examples of how syphilis testing could be integrated with other services
75IntegrationRapid syphilis testing will be introduced to facilities already offering several testing servicesIntegrating services can reduce the work load of HCW and make it easier to perform multiple testsOther rapid testing services are ideal for RST integration
76Integration & Patient Flow Patient Flow describe how patients move throughout the facility to receive servicesEach Facility will have it’s own unique patient flowIntegration of services will differ at each facility according to its patient flow
77ANC Clinic: Patient Flow Patient flow at an ANC clinic offering HIV rapid testing services and no syphilis testing servicesThe diagram highlights the steps a client will take during the HIV rapid testing service beginning with registration. It is a basic overview of patient flow in an ANC clinic using the example of a pre-existing HIV-PMTCT service
78ANC Clinic: Patient Flow Patient flow at an ANC clinic offering HIV and syphilis rapid testing services without integration
79ANC Patient Flow: Integrated Approach Patient flow at an ANC clinic offering integrated HIV rapid testing services and syphilis testing services
80Possibilities for Service Integration HIV PMTCTHIV PICT or VCTRapid Malaria TestingHb TestingOther diagnostic tests requiring a finger-prick of blood drawHIV PMTCT: Prevention of Mother to Child Transmission of HIV, offered in ANC clinics, usually to first time attendersHIV PICT: Provider Initiated Counseling and Testing, offered to outpatients, the health care provider initiates a conversation on HIV counseling and testing. Testing is only provided if the patient consents.HIV VCT: Voluntary Counseling and Testing, offered to outpatients, patients seek out counseling and testing for HIV at their own initiative
81Integrated Patient Flow DESCRIBE WHAT INTEGRATION OF SERVICES WILL OCCUR IN YOUR PROGRAMMEDESCRIBE HOW SERVICES WILL BE INTEGRATED IN YOUR PROGRAMMEThe information for creating this slide will depend on where rapid syphilis testing is going to be introduced and what services are already being offered at the site. This slide will be unique to your program and should be created in accordance with the program overview. For more information on service integration within your program, consult the program manager.
82Integrated Patient Flow CREATE A DIAGRAM SHOWING PATIENT FLOW FOR THE SERVICES THAT WILL BE INTEGRATED WITH RAPID SYPHILIS TESTINGTHIS SHOULD BE DONE IN THE SAME STYLE AS ABOVETHE DIAGRAM SHOULD HIGHLIGHT WHERE INTEGRATION IS GOING TO OCCUR IN THE CLINICINSERT DIAGRAM ON THIS SLIDEThe information for creating this slide will depend on where rapid syphilis testing is going to be introduced and what services are already being offered at the site. This slide will be unique to your program and should be created in accordance with the program overview. For more information on service integration within your program, consult the program manager.
83Health Care Worker Responsibilities Continue to provide clients/ patients with a high degree of careContinue to follow the SOPs for each test procedureContinue to provide clients/ patients withADD any additional responsibilities the HCW
84Possible ChallengesMixing up tests (forgetting which is which during testing)Mixing up buffer reagentsIncorrect entering of results in registerTiming
85Solutions Be well prepared for testing Have each SOP present on the testing benchIf the test cassettes have a similar appearance, label them (ex. “HIV” and “syph”)Keep the buffer reagents next to the test kit during testHave the register near the testing bench and carefully transfer resultsPrepare both tests simultaneously and start the timer when the buffer reagent is added to the first test
86Questions for Participants What services does your facility currently integrate?What opportunities are there for further integration?In your experience, has integrating services been beneficial for the health care provider? For the client/ patient? Why?
87Safety at the Testing Site Rapid Syphilis Testing:Workshop for the Training of HCW[Enter date, location of workshop]
88Learning Objectives By the end of this module, participants should be able to:Define safetyIdentify potential hazards associated with rapid syphilis testingDescribe how to dispose of biohazardous materialsDescribe the safety precautions which need to be observed when testing for syphilis
89Performance Objectives By the end of this module, participants will beable to:Adhere to personal health and safety practicesMaintain a clean and organized workspaceDisinfect and dispose of infectious materialsTake appropriate actions following accidental exposure to potentially infectious specimenFollow written safety procedures and keep proper safety records
90What Is Safety?Safety is the state of being safe and protected from danger, harm, or infection
91Why Is Safety Important? Coming in contact with human blood or blood products is potentially hazardousSafety involves taking precautions to protect yourself and the client against infectionAll specimens should be treated as potentially hazardous
92What Else Needs Protection? Other people who may come in contact with testing by-productsThe testing materialsThe environment (from hazardous material)
93Universal Precautions Every specimen should be treated as though it is infectious
94Apply Safety Practices Throughout the Testing Process Before Testing (Pre-analytical)Specimen collectionSpecimen preparationSpecimen transportTesting (Analytical)TestingAfter Testing (Post-analytical)Disposal
95Develop Personal Safe Work Habits Wash hands before and after testing specimensWear a fresh pair of gloves at a lab coat or apronDispose of contaminatedsharps and waste immediatelyafter use
96Develop Personal Safe Work Habits Pipetting by mouth is strictly forbiddenNever eat, drink or smoke at the testDo not keep food in the laboratory refrigeratorDo not leak anything in the lab (ex. pen, pencil)
97Maintain Clean & Orderly Work Space Keep work areas clean and organizedDisinfectant work surfaces dailyRestrict or limit access to test area when workingKeep supplies locked in a safe and secure areaKeep emergency eye wash units in working order and within expiry date
98Take Precautions to Avoid Needle Stick Injury What can cause needle stick injury?Lack of concentrationInexperienceLack of concern for othersImproper disposal of sharps
100Do’s and Don’t of Waste Disposal DO NOT: break, bend, re-sheath or re-use lancets, syringes or needlesDO NOT: shake sharps containers to create space
101Do’s and Don’ts: Sharps and Waste Containers What’s wrong with this picture?
102Never Place Needles or Sharps in Office Waste Containers
103Sharps Containers Must Be Placed near workspaceClosed when not in useSealed when ¾ full
104Do’s and Don’t of Waste Disposal DO NOT EVER place needles or sharps in office waste containersDO: place sharps containers near workspaceDO: close sharps containers when not in useDO: seal sharps containers when ¾ full
105Policy for Handling Sharps The user is responsible for disposal of sharpsMust dispose of sharps after each useMust place sharps in sharps containersDo not drop sharps on the floor or in the office waste binPlace sharps container near your workspaceSeal and remove when container is ¾ fullDispose of all waste appropriately
106Incineration of WasteIncineration is burning of contaminated waste to destroy and kill micro-organismsIncineration is:Effective against potential re-useProtects the environment and nearby communitiesMust be supervised
107Disinfect Work Areas Use an approved disinfectant (ex. JIK) Kills germs and pathogensKeeps work surface cleanPrevents cross-contaminationReduces risks of infection
108In Case of a Spill or Splash Wear clean disposable glovesImmediately and thoroughly wash any skin splashed with bloodLarge spills: Cover with paper towels and soak with 0.5% Jik and allow to stand for at least 5 minutesSmall spill: Wipe with paper towel soaked in 0.5% JikDiscard contaminated towels in infectious waste containers
109In Case of an Accident What types of accidents can happen? Potential Injury (needle sticks, falls)Environmental (splashes, spills)Equipment damageWhat should you do?Report to your supervisor immediatelyAssess and take actionRecord using formMonitor situation
110Action Plan for Implementing Safety Practices Identify hazardsEstablish and implement safety policies and proceduresConduct safety specific trainingMust be a priorityCommunication is keyPerform regular audits or assessments
111All procedures should be posted or visible in the workspace Safety DocumentationFull safety requirements for testing blood/ serum specimens are very detailedAny site performing testing should have a complete set of country guidelinesEvery staff member should read and understand the safety manual before being allowed to workEveryone is responsible for personal safety and the safety of their co-workersAll procedures should be posted or visible in the workspace
112Questions for Participants What is safety and why is it important?What is the universal precaution you must take when dealing with specimens? Is this something that you observe at your job?What safety procedures do you have in place at your clinic or laboratory?Have you ever encountered a spill? How did you manage it?
113Preparation for Testing Rapid Syphilis Testing:Workshop for the Training of HCW[Enter date, location of workshop]
114Learning Objectives By the end of this module, participants should be able to:List and identify all the supplies required to perform rapid syphilis testingList and identify all the components of a test kit for rapid syphilis testing
115Guidelines For The Use of RSTs Do NOT:Use kits beyond the expiry dateUse damaged kits, materials or suppliesRe-use tests, materials or suppliesExpose kits to direct sunlightMix lot numbersUse Reagents from one kit with those of another
116Guidelines For The Use of RDTs Do:Use old kits firstUse a test immediately once opened
117Preparing for TestingBefore performing a syphilis test, staff should review the following checklist:Do you know what test you are going to perform?Are all supplies and materials needed to perform the test arranged on your workspace?Have you read the SOP?Have you counter-checked the sample against the working list?
132Examine Test Kits Display test kits used in-country Examine the different components found in each of the Rapid Test kits, for exampleDesiccant packet – This is not used when performing the test. It only serves to keep the packet contents dry before use. It should be discarded when the test kit packet is opened.Buffer solution – Required by some kits
134Questions for Participants What is each of these items used for:GlovesAlcohol swabsCotton balls or gauzeSterile lancetsPipetteTimerStandard operating proceduresMarking pensSharps disposal binsDisinfectant jarJik
135Questions for Participants List the components of a Rapid Syphilis Test Kit:
136Orientation to Rapid Syphilis Testing Workshop for the Training of HCW[Enter date, location of workshop]
137Learning ObjectivesAt the end of this module, participants should be able to:Describe how to perform a finger prickDescribe how to perform a rapid syphilis testInterpret the result of a rapid syphilis testThis module with introduce participants to two SOPs: performing a finger prick and performing rapid syphilis testing. The SOPs will be unique to each program so this presentation has been left blank. It is the responsibility of the program manager and trainer to update the presentation slides with the content from the SOPs. Limit the information presented on each slide to three bullet points (or three steps from the SOP) and at the end of the presentation, review the SOP again in its entirety.
138Performing a Finger-Prick ENTER THE STEPS FROM THE PROGRAM-SPECIFIC SOP FOR PERFORMING A FINGER PRICK
139Performing a Finger-Prick INSERT THE STEPS FROM THE PROGRAM-SPECIFIC SOP FOR PERFORMING A FINGER PRICK
140Rapid Syphilis Testing INSERT THE STEPS FROM THE PROGRAM-SPECIFIC SOP FOR PERFORMING A RAPID SYPHILIS TESTING
141Rapid Syphilis Testing INSERT THE STEPS FROM THE PROGRAM-SPECIFIC SOP FOR PERFORMING A RAPID SYPHILIS TESTING
142Rapid Syphilis Testing INSERT THE STEPS FROM THE PROGRAM-SPECIFIC SOP FOR PERFORMING A RAPID SYPHILIS TESTING
143Rapid Syphilis Testing INSERT THE STEPS FROM THE PROGRAM-SPECIFIC SOP FOR PERFORMING A RAPID SYPHILIS TESTING
144Interpreting the Results INSERT THE INFORMATION FROM THE SOP ON HOW TO INTERPRET THE RESULTS OF A RAPID SYPHILIS TEST (POSITIVE, NEGATIVE, INVALID) DETAIL WHEN TO REPEAT THE TEST (INVALID RESULT ONLY)
145Documents and Records Rapid Syphilis Testing: Workshop for the Training of HCW[Enter date, location of workshop]
146Learning Objectives By the end of this module, participants should be able to:Tell the difference between a document and a recordExplain the rationale for maintaining documents and recordsProvide examples of documents and records kept at the test siteDescribe how to properly keep and maintain test site documents and records
147What are Documents and Records? Information captured on worksheets, forms, charts and computer databasesDocumentsWRITTEN policies, process descriptions, procedures, and blank formsUsed to communicate informationRECORDS
148Documents Are the Backbone of the Quality System Verbal instructions are often:Not heardMisunderstood/ MisinterpretedQuickly forgottenIgnoredPolicies, standards, processes, and procedures must be written down, approved, and communicated to all concerned.
149Record-Keeping Proper record-keeping makes quality management possible Record-keeping allows a test site to:Communicate accurately and effectivelyMinimize errorMonitor quality systemAssist management in:Developing plans & policyMonitoring and evaluating programsStock managementEnhance Operational Research
150On-site Records Records that should be kept on-site include: Specimen transfer logsSyphilis request/ client test resultLab/ Test registerAccident recordsPersonnel recordsWorksheetsTemperature logsEquipment maintenance logsInventory recordsQuality assessment:Monitoring reportsRetesting reportsCorrective action
151Good Record-Keeping Understand the information to be collected Record the information every time; at the right timeRecord all the informationRecord the information in the same, standard way every time
152Records: Permanent, Secure, Traceable Keep books boundNumber pagesUse permanent inkControl (limit) storageTraceable:Date and sign every recordSecure:Maintain confidentialityLimit accessProtect from environmental hazards
153Logbooks Are Cumulative Records of Test Site Operations Should be indexed to allow for easy retrieval of dataShould be stored to minimize deteriorationLogbook may refer to a client or patient register or a syphilis testing register.This is one example of a record which should be kept up to date at a facility.Question: What is missing from the red circles on the photo on the left?Answer: The end-date. Log books and registers should be clearly labeled with a start and end date. This way, if anyone needs to check back on an entry, it will be easy to locate the correct register.
154Client/ Patient Records Should be completed when the client/ patient is presentWriting should be legibleAll records should be signed and dated by the responsible HCWShould be stored in a secure location for patient confidentialityThe “responsible HCW or laboratory staff” refers to the individual who was responsible for caring for the client/ patient and providing services. If two HCW are present for the consultation, only one needs to sign and date the record.
155Retaining RecordsThe length of time records should be stored at a facility depends on:National policiesSecure storage space at a test facilityREFER TO NATIONAL GUIDELINES FOR MORE INFORMATION ON STORING RECORDS.It is important that records are stored in a secure location so that patient confidentiality is not compromised.
156Key MessagesWritten policies and procedures are the backbone of the quality systemComplete quality assurance records make quality management possibleKeeping records facilitates meeting program reporting requirements
157Exercise! Which of the following are documents and which are records? Country testing algorithmSafety manualClinical test resultsSOPsManufacturer test kit insertsSummary form of findings from monitoring reportDocuments: Country testing algorithm, Safety manual, SOPs, Manufacturer test kit insertsRecords: Clinical test results, Summary form of findings from monitoring report
158Exercise! Which of the following are documents and which are records? Report of corrective actionsTemperature log (blank form)Daily maintenance log (completed)Stock cards and stock book (completed)EQA specimen transfer log (completed)Documents: Temperature log (blank form), Quality control record (blank form)Records: Report of corrective actions, Daily maintenance log (completed), Stock cards and stock book (completed), EQA specimen transfer log (completed)
159Questions for Participants What are some examples of documents and records maintained at your facility?How long are records kept at your facility?Does your facility have enough secure storage space to store records?Why do you think all records should be signed and dated?Records should be signed and dated to ensure traceability. In case there is ever a problem with a test result this will allow a supervisor/ monitor to refer to the HCW who performed the test and consulted with the patient.
160Standard Operating Procedures Rapid Syphilis Testing:Workshop for the Training of HCW[Enter date, location of workshop]
161Learning Objectives By the end of this module, participants should be able to:Describe the importance of an SOPDescribe when an SOP should be used and where it should be storedGive five examples of SOPs
162Standard Operating Procedure SOPs are written procedures which describe how to perform an activitySOPs should be located directly at the working placeOnly the current version should be presentSOPs should describe how procedures work and not how they are supposed to workSOPs should be written or thoroughly reviewed by instrument’s operators
163Standard Operating Procedures Describe how to perform various tasks in a testing siteProvide step-by-step instructionsAssure:ConsistencyAccuracyQualityStandardization
164Importance SOPs define how to carry out protocol specified activities Standardizing techniques facilitates comparison of resultsEssential component of a quality system
165Content of SOPs Unique SOP number and version number Page number and total number of pagesObjectives/ purpose of the SOPScopeResponsibilityPrincipleProcedures/ instructionsReference
166Content of SOPs Safety Storage Specimen collection Specimen storage Test requirements (pre-test)Validity of testInterpretation of results
167Content of SOPs For equipment testing an SOP should contain: Performance acceptance criteriaRecommended corrective actionsTemplate for continuous entries of test results and corrective actions
168Example of the first page of an SOP. Note key features.
169Controlled Documents SOPs are controlled documents SOPs must be approved for use in-countrySOPs must have document control featuresSOPs must be kept up-to-date
170Manufacturer Product Insterts Do not rely solely on manufacturer product insertsProduct inserts do not provide specific information for test sitesExamples additional material include:Materials required, but not in the kitMaterials in the kit that may not be used in some settingsSpecific safety requirementsExternal quality control requirements
171Examples of SOPs SOP: Performing a Finger Prick SOP: Performing a Rapid Syphilis TestSOP: Re-constituting Dried Tube SpecimenSOP: Testing with a Dried Tube SpecimenSOP: Routine Quality Control TestingSOP: Proficiency Panel TestingSOP: Monitoring
172SOPs At the Test Site Daily routine schedule/ duty roster Country testing algorithmSafety manualsSafety precautionsBlood collection:Fingerprick, venipuncture, DBSTest proceduresQuality Control and Quality Assurance ProceduresInternal assessmentsReordering of supplies and test kitsEquipment use and maintenance
173SOPs Must Be Followed Why is it important to follow SOPs? What are the consequences if you don’t?
174Questions for Participants In your setting, who writes the SOPs?What is your opinion on this arrangement in your setting?Peter photocopied an SOP and gave the copy to a friend who is not working in his office. Is there anything wrong here?
175Supply & Stock Management Rapid Syphilis Testing:Workshop for the Training of HCW[Enter date, location of workshop]
176Learning ObjectivesBy the end of this module, participants should be able to:Identify and describe the different supply management toolsUnderstand and appreciate the importance of these tools in commodity management and reporting and ordering supplies in a timely mannerDescribe the procedures in completing the tools
177Stock Keeping Records Track stock on hand Useful for determining consumption in the absence of dispensed-to-user dataTrack losses and adjustmentsTrack expiry datesUseful tools for accountability problems
178Physical CountProcess of counting by hand the actual usable quantities of a given commodity available at a given timeRecommended at the end of the report period before placing an order
179Importance of Physical Count To check that recorded stock card balances match actual quantities on the shelvesTo verify product qualityIdentify any losses/adjustmentsTo identify and correct errors in the stock cardAccountability
181Stock RecordsTrack quantities of goods/ medicines/ test kits dispensed to clients or used in a given period of timeConsumption information vital guide for facility re-supply quantities or needs
182Stock CardsShould be completed every time a stock is consumed or moved between locationsRecords:Balance at the beginning of the dayQuantity consumed, moved or added (if delivery was received)Balance at the end of the dayStock cards should be signed and dated by the HCW responsible for stock management
183Types of Consumption Data Dispensed-to-user data:Information about the quantity of goods actually put in the hands of end usersIssues data:Information about the quantity of goods moved from one level of the system to anothereg. Store room to facility or pharmacy
184How to Order On-time Sufficient quantity Correct forms According to local scheduleSufficient quantityThe quantity of any supply will depend on how often deliveries are received, the turnaround time, and the quantity consumed during one monthCorrect formsIt is important to submit requisitions for equipment and supplies using national forms and to keep a record at the facility*Turnaround time is how long it takes for an order to be received from the time the request is submitted
185Order QuantityOrder a sufficient quantity of supplies to cover the period until the next order plus a buffer stockBuffer stockQuantity of a supply, in addition to that needed for routine patient flow, to prevent stock outsShould reflect the maximum turnaround timeDoes not need to be replaced every monthBuffer Stock: If a facility has a two week buffer supply (maximum turnaround time= two weeks) and supplies are delivered on time, there is no need to order any more than what is required by the consumption at the facility. If supplies are delivered one week late, that means that half of the buffer stock will have been used to prevent a stock out. The next order should be placed for the quantity required by the facility plus an additional amount to replenish the buffer.
186Example! Schedule: Every 3 months Maximum turnaround time: 2 weeks Remaining buffer stock: 1 weekMonthly consumption: 100 tests (25/ week)What quantity of tests should be ordered?
187Answer!Facility Consumption= (tests consumed/ month) x (number of months until next order) Buffer Stock= (tests consumed/ week) x (maximum turnaround time) – (remaining buffer stock) Order Quantity = Facility Consumption + Buffer StockBuffer stock should be replenished so that it is sufficient to cover the maximum turnaround time, at a very minimum. If orders have been unpredictable, it should be increased.
189Receiving Supplies When receiving supplies it is important to: Record the date of delivery and quantity of supplies deliveryThe record should be signed by the individuals who received and delivered the suppliesCheck the supplies for damageStore supplies off the floor in the storage roomUpdate the stock card with the quantity of supplies delivered
190Storage Room A storage room should have: A lock A window To prevent theftA windowFor ventilationA window coverTo prevent rain from entering the roomShelvingAll supplies should be stored off the floorA thermometerTo monitor temperatureStock cardsAll stock cards should be kept with the item
191Questions for Participants How often does your facility order supplies?How much buffer stock does your facility maintain?What is the maximum turnaround time at your facility?How much buffer stock should your facility maintain given the maximum turnaround time?
192Monitoring & Evaluation Rapid Syphilis Testing:Workshop for the Training of HCW[Enter date, location of workshop]
193Learning ObjectivesBy the end of this module, participants should be able to:Define “monitoring” and describe its purposeDefine “evaluation” and describe its purposeDescribe the key differences between monitoring and evaluationDescribe the roles of a HCW and supervisor/ monitor during a monitoring visitIt may also be useful to include a slide on what type of data will be collected during the monitoring visits. This will differ from program to program and will depend on the goals and objectives of the program. Some examples include: number of pregnant women tested for syphilis, number of syphilis positive pregnant women treated for syphilis, number of partners of syphilis positive pregnant women treated for syphilis, number of days of stock outs of key supplies ect.
194Monitoring Ongoing, routine activity Purpose: Observe progress Identify challengesCome up with local solutionsProvide support to health care facility staff
195What to Monitor Personnel & Training Biosafety Facility Documents and RecordsQuality SystemStock and Supply Chain ManagementEach of the fields listed in this slide should be investigated by the monitor during the visit. The intention is to determine the progress the facility has made towards the program goals, to identify possible challenges or barriers to offering testing services and to assist HCW in devising solutions to those challenges.
196Personnel & TrainingEvery individual responsible for performing rapid syphilis testing should:Have a certificate or evidence of training at the facilityBe able to describe the goals of the program and quality system
197BiosafetyEvery facility offering rapid syphilis testing services should have in the testing area:A sharps disposal binA lined biohazard waste disposal binA protocol for disposal/ incineration of facility waste
198Biosafety All staff involved in the testing process should: Be wearing closed toe shoesBe wearing scrubs or an apronHave his/ her hair tied backHave access to soap and water for hand washingHave access to glovesClosed toe shoes are standard in laboratories to protect the feet from spills or sharps
199FacilityEvery facility offering rapid syphilis testing services should have:A table, counter or lab bench with adequate space for performing testingWindows or electrical lighting to light the testing areaAccess to waterAbility to communicate with referral centers (personal cell phone, facility cell phone, landline, / internet, two-way radio)
200Documents & RecordsEvery facility offering rapid syphilis testing services should:Have a patient or testing register (or both) to record test result and treatment outcomeStore the patient or testing register (or both) in the testing areaRecord if partners were treatedRegularly update the register(s) and sign next to test resultsEnsure the register (s) are organized and the writing is legible
201Quality System Every facility offering rapid syphilis testing should: Have a dedicated folder for quality system records and SOPsHave an up-to-date record of proficiency panel testing and routine quality testing resultsDocument all actions taken in the event of a out-of-specification result (Routine Quality Testing)Have documentation of the results of the proficiency panel testing and any corrective actions takenHave quality records signed by a facility in-charge or supervisorThe records and documentation a facility will have as part of its quality system will depend on the components of the quality system implemented alongside the rapid syphilis testing program. This slide will need to be adapted to reflect the program’s quality system.
202Stock & Supply Chain Management Every facility offering rapid syphilis testing should have:Locked store room/ cupboardComplete and up-to-date stock cards for all testing materialsRequisition and delivery records stored in a bound folderA schedule/ knowledge of order frequencyKnowledge of facility’s buffer stockCurrent stock of essential supplies for RSTStore Room: No supplies should be stored on the floor to protect again damage. They should be stored on shelving or on empty boxes, off the floor. The room/ cupboard should be locked to prevent theft. The room or room the cupboard is in should have a window for ventilation and a window cover to protect again rainfall damage supplies.Stock Cards should be stored with the item in the store room or in a bound folder and should contain up to date information on dispensed to user data, issues data and wastage data. Deliveries should also be recorded on the stock card. All completed stock cards should be bound and stored in a folder with stock and supply management records.
203How to Monitor Routinely By trained monitor or trained supervisor Bi-weekly, monthly, quarterlyBy trained monitor or trained supervisorUsing a program specific checklist and interviews with facility staff
204How Often to Monitor More intensive after initial test introduction Decreased frequency after 3 monthsIn-line with national and district supervisory visitsDepends on available resources and accessibility of facilitiesIf monitoring visits align with supervisory visits, the two can be conducted at the same time. Eventually the supervisor may be able to incorporate monitoring rapid syphilis testing into routine supervision which would benefit the sustainability of the program.
205Responsibilities of Facility Staff To record client/ patient information in the national registerTo record syphilis test result, treatment and partner treatment (if any) in the client/ patient or syphilis testing registerTo maintain daily stock card and complete requisition and delivery supply recordsTo perform routine quality control testing/ proficiency panel testing as per program guidelines and record results appropriately
206Responsibilities of Monitor To routinely visit health care facilitiesTo conduct a monitoring visit in a professional manner, using the checklist as a guideTo interview facility staff (experiences with test, supply chain, quality system)To identify any potential barriers/ challenges to testing based on the results of the visit and interviewsTo work with facility staff to come up with workable solutions to the challengesTo provide facility staff with support throughout program implementation
207Evaluation Summative process Takes place at the end of a program Purpose is to summarize program project towards meeting objectives and achieving goalsReflects on overall success or failure of a programDoes not generate problem solving initiativesSummative: Evaluation occurs at the end of a program or at pre-defined reporting periods such as every 3 or 5 years. It is performed to evaluate the progress a program made towards fulfilling its objectives and achieving its goals.
208Questions for Participants What support have you received from supervisors or monitors in the past?How has this been helpful?How often is monitoring/ supervising carried out in your district/ region?What is the current role of the HCW and supervisor during the visits?
209Quality Control Rapid Syphilis Testing: Workshop for the Training of HCW[Enter date, location of workshop]
210Learning objectivesBy the end of this module, participants should be able toDefine Quality ControlDescribe trouble shootingList the benefits of QC in rapid testingDifferentiate between internal Quality Control and External quality controlDescribe the process of maintaining QC records
211What is Quality Control (QC)? Comprises those measures that must be included during each test run to verify that the test is working properly.These are activities performed to detect and correct errors that may occur during testingIf an error occurs, do not release or report results until you have corrected the error.
212Quality Control Internal Control: External Control: Included in the testing device or as part of the kitTo determine if adequate quantity of specimen has been added to the wellExternal Control:Not included in the test device or kitSpecimens labeled with expected result are used to validate the reliability of the test cassetteCTSControl Band
213External Quality Control Involve the use of known positive and negative or control materialsThese may be purchased from a manufacturer or made locally ( usually by reference lab)These positive and negative specimens are used to evaluate the accuracy of the test cassetteUsually tested periodically in order to ensure the kits are accurately detecting treponemal antibodies
214External Quality Control Samples Manufactured at Central Laboratory or/ purchased from commercial retailersStore according to SOP or local instructionsRecord date when openedUse before expiry dateDo not contaminateQuality Control Samples are potentially infectious and should be treated with appropriate safety precautions and disposed as biohazardous waste
215Sources of External Quality Control Samples Store according to instructionsRecord date when openedUse before expiry dateDo not contaminateCommercially preparedPrepared by Reference Laboratory
216Frequency of Use: When Should You Test External Control Samples? Once a week, beginning of the weekNew shipment of test kitsBeginning a new lot number of test kitsWhen environmental conditions exceed range needed for stability of kitsThe frequency of testing will depend on the programme requirements. Refer to programme manual for more information.
217Invalid Results – What Do You Do? Repeat test using a new test cassette from same kitRepeat test using new test cassette from a new test kitRepeat test using a new test cassette and a new control sample
218Invalid Results – What Do You Do? If repeatedly invalid:assume problem with test kit or procedureInform supervisorTake corrective actionsDocument testing, invalid result, any repeat testing or corrective action taken, sign and date record, have supervisor sign record
219Troubleshooting Invalid Results ProblemPotential CauseActionNo control line or band presentDamaged test device or controlsRepeat the test using new device and blood sampleProper procedure not followedFollow each step of testing according to SOPRe-check buffer and/or specimen volumesWait for the specified time before reading the testExpired or improperly stored test kits or controlsCheck expiration date of kits or controls. Do not use beyond stated expiration dateCheck temperature records for storage and testing area
220Troubleshooting Invalid Results – Cont’d ProblemPotential CauseActionPositive reaction with negative external control, i.e. false positiveIncubation time exceeded recommended time (SOP)Re-test negative control using a new device and read results within specified time limitExtremely faint control lineThe control linecan vary in intensityNo action required. Any visible line validates the results.
221Exercise #1: Interpreting Syphilis Rapid Test Results Refer to the handout in your participant manualRead the test results and write your interpretation in the space provided.Time: 2 minutes
222Quality Control Records Testing Sites Information should include:A standard worksheet that includes spaces for recording QC resultsA separate register for QC results to which Information will be transferred from the worksheet.A flow chart for Corrective action showing steps followed when the QC results do not read as expected and how to refer problems back to the reference laboratory.The qualified Officer should regularly review all QC data with responsibility for testing site.
223Maintaining Quality Control Records HOW? Use standard worksheetsWHY? Trouble-shooting Part of routine inventory – proof of reliable test resultsWHEN?Each time QC materials are testedRecord all invalid results and inform supervisor
225Periodic Review of Records Review of internal control results before accepting test resultsReview of external control results by test performerWeekly or monthly review of external quality control results by testing site supervisorPeriodic audits or assessments
226Questions for Participants What would you do if your external control tested invalid.Give examples of problems encountered with QC results, how they occurred and how to correct themWhy is it important to maintain records of QC results
227External Quality Assurance & Dried Tube Specimens Rapid Syphilis Testing:Workshop for the Training of HCW[Enter date, location of workshop]
228Learning ObjectivesBy the end of this module, participants should be able to:Describe the benefit of DTSDescribe the purpose of Routine Quality Control Testing and Proficiency Panel Testing, and the differences between the two proceduresCorrectly complete all forms required by the quality system
229Dried Tube SpecimensDried Tube Specimens (DTS) are vials containing dried out plasma samplesSpecimens can be syphilis positive or negative, HIV positive or negative, or any combination of syphilis and HIV positive or negativeCan be transported and stored at room temperature
230Preparation of DTS Manufactured by central laboratory Use syphilis (or HIV) confirmed positive and negative plasma samplesBlue dye is added to sample20ul of sample with dye is distributed into the vialVial is left under biosafety hood for 24 hours to dry
231Preparation of DTSOnce dry, vials are labeled, capped, and frozen for long-term storageVials can be distributed to facilities as part of quality systemFor transport and short-term storage (2 weeks), DTS can be stored at room temperature
232How to Use DTS First need to Re-Constitute: Gently tap the tube to ensure colored pellet is at the bottom of the tubeAdd buffer using pasteur pipetteCover the tube (close cap) and tap gently to mixLeave overnight at room temperature
233How to Use DTS The next day: Mix the specimen by gently tapping the tubeThe specimen can be now be used for testingFollow the SOP for Performing Rapid Syphilis TestingRecord results using appropriate forms
234Caution!Gloves and appropriate bio-safety precautions should be taken when handling DTS (re-constitution and testing) The specimen should be treated as potentially infectious
235DTS and Quality Systems DTS is a valuable tool in quality systemsIt can be used for routine quality testing, proficiency panel testing or incoming inspections of test kitsDTS can be sent to peripheral labs and facilities because it can be stored at room temperature
236Routine Quality Control Uses DTS which are labeled either positive or negativeThe label also contains lot number and expiry dateVials are called ‘known’ because the expected test result is know (written on label) before the test is performed
237Routine Quality Control: Purpose Purpose: to assess the ability of the test cassette to correctly identify positive and negative samplesAnswer the question “Is the test working?”Ensure tests were not damaged during transport to the facility or during storage at the facility
238Routine Quality Control: Results If the known positive gives a positive result and the known negative DTS gives a negative result, the tests are said to be “in specification”If the known positive DTS gives a negative result or the known negative DTS gives a positive result, the tests are said to be “out of specification”
239Routine Quality Testing: Results The lot number, expiry date, expected result and actual results should be recorded on the appropriate form along with the date, and name of tester and signature of testerIf the result is out of specification, the tester should follow the corrective actions steps to determine the problemThe actions should be recorded an signed off by a facility supervisor/ in-charge
240Corrective ActionsIf there is an out of specification result, it may be because the test was invalid, the test kit was damaged or the DTS sample was damaged during transport and storageTo determine if the problem was with the test cassette, repeat quality testing using a new test cassette from the same test kit
241Corrective ActionsIf the test result is still out of specification, repeat the test using a new test cassette from a different test kitIf the test result is still out of specification, re-constitute a new vial of DTS and repeat using a test from the first kitIf the test result is still out of specification, do not use either test kit in the clinic and contact the monitor/ supervisor for further instructionsIf the test result is in specification, this means the problem was with the vial of DTS and not the tests, continue using the tests in the clinicIf a
242Routine Quality Testing: Frequency May be performed every week, every two weeks, every month, or for every new kitFrequency will depend on the volume of patients being testing and the rate of test consumption at a facilityInsert information on the frequency of routine quality testing as per program protocol. This will be highly program specific and may even differ between facilities depending on the level of patient flow.
243Proficiency Panel Testing Also uses DTSDTS labels contain an identification code and expiry date but not the expected test resultPurpose: to determine if the facility/laboratory staff member is correctly performing and interpreting the results of a rapid syphilis test
244Proficiency Panel May contain up to six DTS May include strong and weak positive samples and negative samplesDTS are reconstituted a day before testingTests should be performed and interpreted according to the SOP
245Proficiency Panel: Documentation Date of testing, DTS identification code and expiry date, test result, name of tester and signature of tester are recorded on the correct formResults are submitted to central laboratoryMonitor will provide facility with written copy of results and overall scoreAny corrective actions will be documented in the facility’s quality systems folder
246Who Should Perform the Proficiency Panel? Should be performed by all facility staff who perform rapid syphilis testing as part of routine careEach person should conduct testing using the panel independently and should not share resultThe panel is to identify individuals in need of support and is intended as a tool to improve the quality of testing services for the benefit of the client/ patient
247Proficiency Panel: Results Facility score can identify individuals or groups of individuals having trouble performing the test or interpreting resultsHighlights where monitor should focus attentionCan be used to identify when and where on-the-job retraining or large re-fresher training workshops are required
248Questions for Participants What question is proficiency panel testing trying to answer?What are the key differences between routine quality testing and proficiency panel testing?Do any other programs at your facility have a quality system in place?