Knowledge Checklist -- Implant Checklist to assess provider’s knowledge level relative to performance expectations for Implant service delivery Key to type of service for which checklist criteria apply A = Implant Counseling Type of Service B= Implant Insertion Knowledge Expectations1 C = Implant Follow-up D = Implant Removal Is provider able to sufficiently and correctly describe at time of assessment? Yes () No2 () Comments A*,B,C,D A*,B,C,D Mechanism of action (how the Implant works) Efficacy (how effective the Implant is in preventing pregnancy and for how long it remains effective) A*,B Method benefits to client A*,B* Medical eligibility criteria (who can safely use the Implant and who should not use it) A*,B* When a woman can start using the Implant A*,B,C*,D Side effects (what they are, how common they are, how they may subside with time, how to manage them) A,B*,C*,D Potential complications and risks (what they are, how likely/or not they are to occur, and warning signs of their occurrence) C* What steps to take if warning signs are present A,B* When a woman should seek out follow up care (routine follow-up and if experiences problems) Next Steps: Record all “no” responses in training recommendations section of PPA Form Part 2 Note: All providers delivering any aspect of Implant services should have general and accurate knowledge about the Implant and for whom it is an appropriate method. It is particularly important that providers performing counseling services are capable of accurately informing clients about all aspects of the Implant so that clients can make an informed choice about using the method. Providers who will be involved in delivering follow-up services should be particularly knowledgeable about issues concerning Implant side effects and complications. *indicates that it is especially important for this type of provider to be knowledgeable in this aspect of the Implant. 1 Refer to Annex 1(Technical Information about the Implant) of the Implant Service Delivery Protocols for what “correct and sufficient” responses to knowledge expectations listed in checklist would be. 2 Wherever the answer is “no”, the provider should be educated according to information contained in Annex 1(Technical Information about the Implant) of the Implant Service Delivery Protocols. PSI Global Quality Assurance Manual – Implant checklists adapted from JHPIEGO and manufacturer materials. Initial Skills Assessment Guide -- Implant (To be used for initial assessment of training needs only. Not required for post-training or supervisory assessment.) Key to type of service for which checklist criteria apply A = Implant Counseling B= Implant Insertion C = Implant Follow-up Type of Service Question to ask provider D = Implant Removal Action3 (circle one for each question) If Yes, evaluate according to: If No, train on this information Do you have training and/or experience in counseling clients about family planning in general? Do you have training and/or experience in counseling clients about implants specifically? Skill Level Checklist – section on counseling 2 Skill Level Checklist -section on counseling 2 B Do you have training and/or experience in assessing client’s medical eligibility for implant? 4 B Do you have training and/or experience in performing an implant insertion? Do you have training and/or experience in practicing infection prevention procedures related to implant service provision? Do you have training and/or experience in assessing and/or managing side effects or complications associated with implant? Do you have training and/or experience in performing an implant removal? Skill Level Checklist -section on preinsertion screening Skill Level Checklist – section on insertion Skill Level Checklist – section on infection prevention Skill Level Checklist – section on follow-up Skill Level Checklist – section on removal 8 Conduct assessment using relevant section(s) of tool(s) circled Record all circled sections in training recommendations section of Provider Performance Report A A B,C,D C D Next Steps 5 3 7 3 Where answers are “yes”, providers skills should be evaluated in terms of how well they perform each and where their skills need improvement using relevant sections of the Skill Level Checklist for Implants. Where answers are “no”, do not attempt to evaluate skill level. Make sure that the indicated sections of the Implant Service Delivery Protocols are emphasized in their training course. PSI Global Quality Assurance Manual – Implant checklists adapted from JHPIEGO and manufacturer materials. Skill Level Checklist -- Implant Checklist to assess provider’s skill level relative to performance expectations for Implant service delivery Name of Provider Assessed _______________________________________ Name of person who performed this assessment __________________________ date __________________ Key to type of service for which checklist criteria apply A = Implant Counseling B= Implant Insertion C = Implant Follow-up D = Implant Removal Scoring Key P C NA Proficient -- Provider demonstrates ability to perform procedure, executing all indicated tasks without guidance; does not require further training Competent -- Provider acceptably demonstrates ability to perform procedure, executing most of the indicated tasks with little or no guidance; while sufficiently competent to provide services, the provider would benefit from continued intermittent oversight to improve confidence and overall ability. Not Acceptable -- Provider does not acceptably demonstrate ability to perform procedure and does not execute the necessary indicated tasks; provider must continue with training or supervised practice before beginning Implant service delivery Service Skills Expectations ( COUNSELLING A Performs pre- insertion counseling according to protocol (P, C, or NA) a) Interacts with client in a respectful manner b) Asks the client questions to help clarify her reproductive health needs c) Explains what the Implant (and other methods if client has not already decided to use Implant) how it works, and how it might meet her Reproductive health needs. d) Explains possible Implant side effects and reassures client that they are not harmful and that they may subside over time. e) Explains potential complications involved with Implant use and reassures client that she is unlikely to experience any serious problems, especially if she has the Implant inserted by a skilled provider who knows how to minimize risks. f) Explains eligibility criteria and procedures for assessing client eligibility g) Explains insertion procedures h) Checks to make sure that the client understands key messages conveyed i) Answers any question the client has. j) Assists client in making a decision about using the Implant (or another method if appropriate) k) Respects client's choice of family planning method and does not try to coerce/pressure her to use one method over another. Overall Score for Demonstrated Ability in Counseling (P, C, or NA) CLIENT SCREENING A, B Performs pre-insertion screening according to protocol (P, C, or NA) a) Determines that client is not pregnant (acts accordingly if she is) b) Takes client's medical history c) Screens client carefully to make sure there is no medical condition that would be contraindicated for implant insertion Overall Score for Demonstrated Ability in Client Screening (P, C, or NA) INSERTION OF IMPLANT CAPSULES B If YES Takes appropriate steps to get ready for procedure according to protocol (P, C, or NA) a) Checks to be sure client has thoroughly washed and rinsed her entire arm. b) Tells client what is going to be done and encourages her to ask questions. PSI Global Quality Assurance Manual – Implant checklists adapted from JHPIEGO and manufacturer materials. c) Positions woman's arm and places clean, dry cloth under her arm d) Determines optimal insertion area according to type of implant being used e)Prepares instrument tray and opens the sterile instrument pack or HLD container w/o touching the instruments f) Opens implant packaging according to instructions B Conducts pre-insertion preparations according to protocol (P, C, or NA) a) Washes hands thoroughly and dries them. b) Puts sterile or high level disinfected gloves on both hands c) Arranges instruments and supplies so that they are easily accessible d) Preps insertion site with antiseptic solution e) Places sterile or high level disinfected drape over arm. f) Checks with client to be sure that she has never had an allergic reaction to a local anesthetic g) Injects local anesthetic (1% without epinephrine) just under skin; raises a small wheal. h) Advances needle about 4 cm and injects 1mls or local anesthetic in each of one (Implanon) or two (Jadelle/Sino-Implant) subdermal tracks. i) Checks for anesthetic effects before making skin incision. B Inserts the implant according to protocol (P, C, or NA) 1. Jadelle a) Makes shallow 2 mm incision with scalpel just through skin (alternatively, inserts trocar directly subdermally). b) Inserts the trocar and plunger through the incision at a shallow angle with the beveled tip of the trocar facing up and moves the trocar forward, stopping as soon as the tip is completely beneath the dermis. c) While tenting the skin, advances trocar and plunger to mark (1) nearest hub of trocar d) Removes plunger e) Inserts first rod into Trocar sleeve f) Reinserts plunger and advances it until resistance agains the rod is felt. g) Holds plunger firmly in place with one hand and slides trocar out of incision until it reaches plunger handle. h) Withdraws trocar and plunger together until mark (2)nearest trocar tip just clears incision (does not remove trocar from skin) i) Moves tip of trocar away from end of first rod and holds rod out of the path of the trocar. j) Redirect trocar about 15 degrees and advances trocar and plunger to mark (1) k) Inserts remaining rod using same technique. l) Palpates ends of rods to be sure the rods are placed correctly ("V" shape) and palpates incision to check that ends of rods are about 5mm away from incision. m) Carefully withdraws the trocar and presses down on the incision with a gauzed finger for a minute or so to stop any bleeding. n) Removes the drape and cleans the area around the insertion site with sterile disinfectant and cotton or gauze o) Brings edges of incision together and closes it with band aids or surgical tape with sterile cotton. p) Applies pressure dressing snugly. 2) Implanon a) While keeping the shield on the needle, visually verifies the presence of the implant b) Stretches skin around the insertion site with thumb and index finger c) Inserts tip of the needle at a slight angle until the tip of the bevel just barely goes under the skin d) Releases the skin and lowers the applicator to a horizontal position e) Lifts the skin with the tip of the needle PSI Global Quality Assurance Manual – Implant checklists adapted from JHPIEGO and manufacturer materials. f) While tenting the skin, gently inserts the needle to its full length (keeping the cannula parallel to the surface of the skin). g) Breaks the seal of the applicator by pressing the obturator support. h) Turns the obturator 90 degrees with respect to the canulla. i) Fixes the obturator firmly against the arm j) With the free hand, slowly pulls the cannula out of the arm k) Checks the needle for absence of the implant l) Verifies presence of implant by palpitation m) Removes the drape and cleans the area around the insertion site with sterile disinfectant and cotton or gauze n) Brings edges of incision together and closes it with band aids or surgical tape with sterile cotton. o) Applies pressure dressing snugly. B Performs post-insertion tasks according to protocol (P, C, or NA) a) Before removing gloves, places instruments into a container filled with .5% chlorine solution b) Places drape in a dry covered container and moves to designated washing area c) While still wearing gloves, places all contaminated objects in a properly marked leak proof container with tight fitting lid and properly disposes d) Immerses both gloved hands in .5% chlorine solution, then removes and properly disposes of gloves e) Washes hands thoroughly with soap and water f) Completes client record, including drawing position of capsule. g) Instructs client regarding wound care and makes return visit appointment, if necessary. h) Observes client for at least 15-20 minutes before sending home. B Performs post-insertion counseling to protocol (P, C, or NA) a) Reviews key messages for women who have just had an IUD inserted b) Discusses what to do if client experiences any problems following insertions or side effects. c) Assures client that she can have rod(s) removed at any time if she desires. d) Asks client to repeat instructions and answers client's questions. Overall Score for Demonstrated Ability in Inserting Implant (P, C, or NA) FOLLOW-UP C Conducts client assessment according to protocol (P, C, or NA) a)Assesses clients satisfaction with Implant b) Assesses for common side effects. c) Screens for warning signs d) Addresses any questions or concerns the client may have e) Reviews key Implant messages with client Overall Score for Demonstrated Ability in Follow-up (P, C, or NA) REMOVAL D Conducts pre-removal counseling according to protocol (P, C, or NA) a) Asks client her reason for removal and answers any questions b) Reviews client's present reproductive goals and asks if she wants another implant c) Describes the removal procedure and what to expect. D Follows pre-removal procedures according to protocol (P, C, or NA) a) Checks to be sure that all removal equipment is present, in good condition, and has been properly sterilized. b) Checks to be sure client has thoroughly washed and rinsed her entire arm. c) Positions woman's arm over a clean, dry cloth and palpates rod(s) to determine point for incision. PSI Global Quality Assurance Manual – Implant checklists adapted from JHPIEGO and manufacturer materials. d) Confirms the position of each rod by making a mark at both ends of the rod(s). e) Prepares an instrument tray. f) Washes hands thoroughly and dries them. g) Puts sterile or high level disinfected gloves on both hands h) Prepares removal site with antiseptic solution. i) Places high level disinfected drape over arm. j) Injects small amount of anesthetic (1% without epinephrine) at the incision site and under the end of the capsules. k) Checks for anesthetic effect before make skin incision. D Removes implant rod(s) according to protocol (P, C, or NA) 1) Forceps Technique for Implanon a) Pushes down the proximal tip to fix the implant b) Makes a longitudinal incision of 2 mm from below the distal tip of the implant toward the distal tip of the implant c) Gently pushes the implant towards the incision with fingertip until the tip of the implant is visible d) Grasps the implant with forceps and removes it by gently pulling it toward the incision e) Closes the incision with butterfly closure 2) "U" Technique for Jadelle/Sinoplant Rods a) Chooses a point for incision between the rods, about 5 mm from the ends of the rods nearest the elbow b) Makes a small (4 mm) vertical incision with a scalpel to (and between) the long axis of the rods. c) Gently inserts the holding forceps through the incision at a right angle to the long axis of the nearest rod. d) Stabilizes the rod that is closest to the incision by placing the index finger parallel to the rod. e) Advances the forceps until the tip touches the rod. Then opens the forceps and grasps the rod at a right angle to its long axis about 5 mm above the distal end. f) Cleans off and opens the fibrous tissue sheath surrounding the rod by gently rubbing with sterile gauze to expose the rod for easy removal. g) Uses the curved forceps (mosquito or Crile) to grasp the exposed part of the rod. Releases the holding forceps and slowly and gently removes the rod. h) Places the rod in a small bowl containing 0.5% chlorine solution for 10 minutes for decontamination prior to disposal. i) Removes the remaining rod using the same technique (repeats steps c - h) Overall Score for Demonstrated Ability in Removing Implant (P, C, or NA) INFECTION PREVENTION B,D Performs Infection prevention tasks throughout the procedure according to protocol (P, C, or NA) a) Before removing gloves, fills or flushes needle and syringe with 0.5 % chlorine solution and places all instruments in 0.5% chlorine solution for 10 minutes for decontamination. b) Disposes of waste materials by placing in leak proof container or plastic bag. c) Immerses both gloved hands in 0.5% Chlorine solution. Removing gloves by turning inside out. - If disposing gloves, places in leak proof container or plastic bag. - If reusing gloves, submerges in 0.5% chlorine solution for 10 minutes for decontamination d) Washes hands thoroughly and dries them. e) Instruments, gloves and other items are processed and stored according to protocol Overall Score for Demonstrated Ability in Infection Prevention (P, C, or NA) PSI Global Quality Assurance Manual – Implant checklists adapted from JHPIEGO and manufacturer materials. Facility Audit Checklist – Implant Infrastructure/Equipment/Supplies needed to meet performance expectations for Implant service delivery Name of Provider/Facility Audited _________________Name of person who performed this audit ____________ date ________ Key to type of service for which checklist criteria apply A = Implant Counseling Type of Service B= Implant Insertion C = Implant Follow-up D = Implant Removal Infrastructure/Equipment/Supplies In place at time of assessment? Y N Comments () () Facility Infrastructure and Conditions A,B,C,D Space within the facility that offers acceptable privacy B,C,D Clinic environment is acceptably clean B,C,D Hand washing facilities are in working order B,D Adequate Light source Equipment and Supplies A Counseling aid A IEC materials B,D Examination table or similar equipment where the client can lie comfortably B,D Arm support or adjoining side table if exam table is not available B,D Sterile [or High-Level Disinfection (HLD)] surgical drapes B,D Three sterile or HLD bowls (one for the antiseptic solution, one for cotton balls soaked with boiled or sterile water to remove talc from gloves and one to hold rods) B,D Clean Instrument tray B,D Scalpel with #11 blade (for Jadelle® and Sino-Implant (II)® only) B #10 trocar with plunger designed for use with either Jadelle® or Sino-Implant (II)® (for Jadelle® and Sino-Implant (II)® only); B,D Straight tissue/artery forceps (optional B Plastic template for marking position of rods in “V” shape (for Jadelle® and Sino-Implant (II)® only). D 1 curved mosquito or Crile forceps D 1 Norplant®-holding forceps, sometimes referred to as “U” or “modified vasectomy” forceps (for Jadelle® and Sino-Implant (II)® only) Consumables B Implants in unopened, undamaged, sterile packages that are not beyond their expiration dates B,D Surgical Gloves (sterile or HLD) B,D Antiseptic (Lodine/Iodine etc) solution and soap B,D Sterile gauze and compresses B,D Syringe (5 or 10 ml) and long needle (22 gauge; preferably 2 inch, but 1.5 inch is suitable) — this is a longer needle than that used for Norplant® insertion. Single-use syringes are strongly encouraged. B,D Local anesthetic (Lidocaine/lignocaine/xylocaine 1% concentration without epinephrine) B,D Ballpoint pens or markers B,D Ordinary plaster or butterfly bandage, or gauze with surgical tape B,D Epinephrine for anaphylactic shock (readily available for emergency use) Supplies needed for processing instruments to prevent infection B,D Bleach or similar suitable decontaminant B,D Bucket or other container for soaking instruments B,D Scrub brush and soap B,D Heavy utility gloves B,D Waste disposal container B,D Sterilization equipment (working autoclave or oven); or Solution for HLD (Glutaraldehyde or chlorine); or equipment for steaming or boiling instruments PSI Global Quality Assurance Manual – Implant checklists adapted from JHPIEGO and manufacturer materials. B,D Water Record keeping and reporting B,C,D Systematic and confidential record keeping system that enable PSI to collect data B,C,D Provider/facility has procedures for handling and reporting adverse events Next Steps: Record all “no” responses in infrastructure/procurement recommendations section of PPA Form Part 2 Summary of Results Key Indicators of Quality Equipment and consumables needed to perform procedure safely are present at facility Yes No Comments Provider/facility has procedures for handling and reporting adverse events Service-related IEC materials are available at the facility for clients Facility is set up to offer client privacy Accurate and organized client records are kept at facility Client records are stored safely and confidentially If provider is not available for follow-up care, list of PSI-approved referral sites is available PSI Global Quality Assurance Manual – Implant checklists adapted from JHPIEGO and manufacturer materials.