STANDARD OPERATING PROCEDURE: CYSVIEW RECONSTITUTION AND INSTILLATION

Transcription

1 STANDARD OPERATING PROCEDURE: CYSVIEW RECONSTITUTION AND INSTILLATION Version: 1 Purpose: Cysview Reconstitution and Instillation Guidelines Service: OCL Status: Owner Service: Final OCL Nurse Executive: Approval Date: Document Number: Chief of Urology: Approval Date: Page 1 of 4 OCL Executive: ADPCS: Approval Date: Approval Date: Cysview Reconstitution and Instillation Guidelines Cysview is an optical imaging agent indicated for the use in the cystoscopic detection of non-muscle invasive papillary cancer of the bladder among patients suspected or known to have lesion(s) on the basis of a prior cystoscopy. It is used with the KARL STORZ D Light C Photodynamic Diagnosis (PDD) system to perform cystoscopy with the blue light settings (Mode 2) as an adjunct to the white light setting (Mode 1). Important limitations of use: A. Not used as a replacement for random bladder biopsies or other procedures used in the detection of bladder cancer, but to augment the detection of lesions suspicious for carcinoma COMPETENCY A. Competency in the reconstitution and instillation of Cysview will be validated by a Nursing Educator/Nurse Manager/Unit Preceptor and will be documented. GENERAL INFORMATION B. RNs will function within the established Medical Center and Infection Control policies and procedures C. A physician s order is required to instill Cysview. The order should be clear, concise, and complete. The Physician s order should include, but is not limited to: solution/medication, dosage, volume, rate, frequency, and route. The nurse should not initiate therapy and should contact physician or the staff charge nurse for clarification of orders if the order is not clear, legible, or complete. Order should be written in Delayed SACC orders. D. RN will: 1. Review, as per usual standard, the patient history and physical assessment for allergies to imaging agents, medication, antiseptic agents, or tape. 2. Contraindications: porphyria, gross hematuria, BCG immunotherapy or intravesical therapy within 90 days, known hypersensitivity to hexaminolevulinate or any derivative of aminolevulinic acid. 3. Select and use straight, or intermittent, urethral catheters with a proximal funnel opening that will accommodate the Luer Lock adapter. Use only catheters made of vinyl (uncoated or coated with hydrogel), latex (amber or red), and silicone to instill the reconstituted Cysview. Note: Do not use catheters coated or embedded with silver or antibiotics. Indwelling bladder catheters (Foley catheters) may be used if the catheters are inserted shortly prior to Cysview administration and are removed following Cysview instillation. 4. Two attempts for both male and female are allowed before staff will notify Urology. a. First attempt standard urinary catheter b. Second attempt Coude catheter

2 5. Explain the purpose of the instillation and the potential adverse reactions. Bladder spasm (most common 2.2%), dysuria, hematuria, and bladder pain. (The study drug group and control group had similar rates of adverse reactions) 6. Educate the patient/caregiver about signs and symptoms of complications that should be reported to the nurse. CLINICAL GUIDELINES E. Infection Control Measures 1. RNs must follow the infection control guidelines relating to the insertion of a straight, or intermittent, or urethral catheter 2. Proper hand washing techniques will be practiced before and after instillation of imaging agent. 3. Universal precautions must be observed with every patient. Gloves must be worn during reconstitution and instillation of imaging agent. 4. Aseptic technique will be strictly adhered to when reconstituting imaging agent, inserting or discontinuing straight, or intermittent, or urethral catheters. 5. Signs and symptoms of complications will be brought to the physician s attention and documented in CPRS 6. Isolation guidelines will be followed when caring for patients in isolation. F. Reconstitution of Cysview 1. For appropriate reconstitution, Cysview is supplied as a kit containing two vials: a clear glass vial labeled as Cysview (100 mg hexaminolevulinate hydrochloride powder) for Intravesical Solution and a vial labeled as DILUENT for Cysview, containing 50 ml of the diluent in a polypropylene vial. a. Remove the cap from the sterile 50 ml syringe and carefully retain it for subsequent reattachment to the syringe. Attach a needle to the syringe and withdraw 50 ml of the diluent. b. Penetrate the stopper of the Cysview powder vial with the needle and inject 10 ml of the diluent from the syringe into the powder vial c. Without withdrawing the needle from the vial, hold the powder vial and the Luer Lock syringe in a firm grip and gently shake to dissolve the powder in the diluent. (The powder normally dissolves almost immediately) d. Withdraw all of the dissolved solution from the powder vial (10 ml) into the 50 ml syringe e. Remove the needle from the powder vial, disconnect the needle from the syringe tip and discard it. Plug the syringe with the syringe cap f.. Gently mix the contents of the syringe. The reconstitution solution of Cysview is colorless to pale yellow and clear to slightly opalescent, and free from visible particles. 2. Peel off the detachable portion of the label (starting at the corner marked with a black triangle) from the Cysview powder vial and affix it to the syringe containing the solution of Cysview. Add two hours to the present time and write the resulting expiration time and date on the syringe label. 3. If unable to administer the solution shortly after reconstitution, the solution may be stored for up to 2 hours in a refrigerator at 2 degrees 8 degrees C (36 degrees 46 degrees F) in the labeled syringe. If not used within 2 hours, discard the solution.

3 G. Cysview Instillaton Insert the urethral catheter into the bladder of the patient using a standard sterile technique, to drain the bladder prior to administration of Cysview. Administer Cysview appropriately into the bladder at least one hour before the procedure. a. Attach Luer Lock syringe to urethral catheter to administer Cysview into the bladder. b. Slowly instill Cysview into the bladder through the urethral cather. Ensure complete volume of the Luer Lock syringe contents (50 ml) is administered with minimal discomfort to the patient. c. Plug urethral catheter immediately after instillation. Ensure that there is no leakage. d. Educate the patient on retaining the Cysview solution within the bladder for at least one hour prior to the procedure. e. Notify MD of any issues on instillation process prior to the procedure for proper compliance. Note: Patient education brochure from Photocure is available for patient instructions. H. Documentation of Reconstitution and Instillation of Cysview 1. The Pre-operative Preparation of patient/checklist in CPRS or other appropriate nursing assessment note specific to a nursing unit. 2. Documentation in CPRS must include: a. Time of the reconstitution of Cysview b. The expiration time of Cysview (two hours from the time reconstituted) c. Catheter size d. Amount of color of urine prior to Cysview instillation e. Patient s tolerance of urethral catheter placement f. Time of Cysview instillation g. Plugged 3. Ensure that the syringe with the imaging agent has been labeled with expiration time and date (see III, B-2) I. Ordering and Storage of Cysview 1. Maintain a par level of 5 boxes of Cysview. 2. Cysview will be ordered when par level is two (2) from OCL procurement officer. 3. Cysview will be stored in SACC medication room.

4 REFERENCES: J. (Mosby s Skills, 2014) K. 118CPO-001 Medication Administration pdf 1. P:\VAMC Policies\PDFs L. (See What You Have Been Missing In Bladder Cancer, Cysview, 2013) REVISION DATE CHANGES

5 Urinary Catheter Insertion with Lidocaine 2% Jelly Adult Attachment A PURPOSE To provide instruction to patient care providers to use Lidocaine 2% jelly to insert male and female urinary catheters, reduce discomfort and/or risk of injury to the patient s urethra and/or prostate. GENERAL INFORMATION The application of Lidocaine 2% jelly prior to the insertion of a urinary catheter: Assists with the dilation of the posterior urethra Lubricates the urethra to facilitate catheterization Desensitizes the urethra during and after the procedure Provides psychological benefit by validating that the procedure is attempting to reduce discomfort. A physician s order is required for Lidocaine 2% Jelly prior to the insertion of a urinary catheter. Before inserting a urethral catheter, the nurse is responsible to ensure that they have the competency on catheter insertion. Two attempts for both male and female are allowed before staff must seek assistance from an experienced health care professional. After two unsuccessful attempts, notify Urology. NOTE: If the patient has an allergy to lidocaine 2% jelly, a water-based lubricant should be used. No patient care order is required when using water-based lubricant.

6 URINARY CATHETER INSERTION WITH LIDOCAINE 2% JELLY - ADULT Attachment A EQUIPMENT FOR MALE URINARY CATHETER INSERTION EQUIPMENT Lidocaine 2% jelly 20 ml prefilled syringe Commercial single use urethral catheterization tray. Should contain: Sterile drapes Sterile providine iodine solution for cleansing Sterile water soluble lubricant gel Sterile water in a 10 ml syringe Sterile gloves Urethral catheter Consider appropriate catheter size and type for the patient RATIONALE To decrease patient sensation during urinary catheter insertion To maintain aseptic technique Purpose is to drain urine. Male: size French urinary catheter Note: If a patient has never had a catheter inserted, use a size 14 French urinary catheter Coude-tipped catheter Coude catheters are inserted with the tip pointed upward (toward the patient s umbilicus) in the 12 o clock position, throughout insertion. An arrow or raised bump on the catheter shaft indicates the position of the tip during insertion. Coude catheter is passed through the urethra using steady gentle pressure. Note: Do NOT force if firm resistance is met. If a Coude catheter cannot be inserted in accordance with these guidelines after 1 attempt, the patient should be referred to senior staff or a urologist (if available at site) Silicone catheters are made of pure silicone. Preferred urinary catheter for patients with a latex allergy. Note: Silicone catheters the balloon should be checked every 2 weeks and sterile water added as needed Use the urine collection tray. Catheter stabilizing device is required (e.g. StatLock for catheter) Garbage receptacle within easy reach To measure and collect urine output. To minimize trauma to urethra. Commercial prepared devices i.e. StatLock are preferred when available.

7 Attachment A NURSING ACTION AND RATIONALE FOR URINARY CATHETER INSERTION ACTION RATIONALE Check physician orders. A physician order is required. Identify patient per policy (2 patient identifiers) Review the medical history before attempting to insert catheter To identify patients who may have difficulty with insertion. The patient s history helps guide choice of catheter type and size. Patient history, and identifying complicating factors include: Asking patient if they have had a urinary catheter inserted previously Lidocaine/Lidocaine allergy: use water soluble lubricant. Latex allergy: use silicone catheter History of: o Urethral trauma / strictures? o Prostatic enlargement o Prostate surgery If catheter cannot be inserted notify Urology. To identify patients who may have difficulty with Urinary catheter insertion. Latex allergy Assess other catheter options, such as a silicone catheter. Note: Individuals with a history of allergies to bananas, avocado, kiwi, or chestnuts may cross-react to latex. Strict latex precautions, including use of latex-free catheter kits should be followed. Latex reactions from indwelling catheters can range from: Severe anaphylaxis with respiratory distress and generalized urticaria Redness and swelling of the urinary meatus Meatal discharge Complaints of bladder pain Localized urticaria involving the skin in contact with the catheter Explain procedure to patient. Gather supplies Ensure bed or stretcher is positioned at comfortable working height. Position patient in supine position and adjust the bed linen. Before beginning sterile preparation, ensure peri-care is completed. Leave patient genitalia covered until the supplies have been set up. Promotes cooperation. Before beginning the procedure, ensure sterile packaging is intact and expiry dates are checked. Correct ergonomics To ease access to the urethra. To minimize bacterial contamination into the urethra during catheter insertion. Respect and maintain patient dignity.

8 PROCEDURE FOR MALE URINARY CATHETER INSERTION using Lidocaine 2% Jelly Wash hands ACTION Expose patient s genitalia, identify urethra, ensure positioning is appropriate and lighting is adequate RATIONALE To minimize risk of bacterial contamination during catheter insertion. Attachment A Wash hands Note: For uncircumcised patients, the foreskin is retracted for iodine cleansing and for catheter insertion. Failure to return the foreskin back to its original position can cause paraphimosis Particular caution should be used when inserting a catheter into an uncircumcised patient with severe penile and / or scrotal edema because it may be very difficult to reposition the foreskin once the catheter has been inserted Patients with severe edema are also at greater risk for penile erosion. Place the catheter tray on a clean, dry, firm surface i.e. bedside table Maintaining the sterile field: 1. Open catheter tray 2. Open and place the urinary catheter on the sterile field 3. Don sterile gloves maintaining aseptic technique 4. Open the iodine preparatory solution / swab sticks 5. Open sterile lubricant and place package on sterile field 6. Open Lidocaine 2% jelly according to manufacturer s instructions. Prime the Lidocaine 2% jelly to expel air, making sure that jelly is on the tip of the syringe. 7. Place small amount of Lidocaine 2% jelly on sterile field Position sterile drapes over patient, creating a sterile field Place the urine collection tray holding the urinary catheter, iodine swab sticks, package of lubricant on the sterile field, between the patient s legs Ensure no plastic particles from breaking the syringe seal remains. Use to lubricate catheter when ready for insertion. To minimize risk of bacterial contamination during catheter insertion. For ease of insertion and collection of urine.

9 Attachment A Use your non-dominant hand to hold the penis at a 90º angle This hand is now considered to be non-sterile and is used to hold the penis throughout the procedure. Use your dominant sterile hand and sterile iodine swab sticks, or sterile forceps with cotton gauze in iodine solution to cleanse the urethra and the surrounding glans. Use a circular motion with at least three different applications. Slowly instill ml of the Lidocaine 2% jelly prefilled syringe directly into the urethra Inadequate lubrication can cause urethral trauma and pain; this can also result in an inability to pass the catheter through the prostatic urethra. Note: Needles are never used for administration of Lidocaine 2% Jelly This distends and places the lubricant high in the urethra; reducing discomfort and preventing urethral spasm. Hold the penis at a 90º angle. Instilling too fast may cause gel to over flow. Allow approximately 3 to 5 minutes (for the anesthetic to take effect before proceeding with the urethral catheterization. Sterile gauze maybe placed over the meatus post instillation and the urethral opening should be held closed. Lubricate the tip of the catheter into the Lidocaine 2% jelly placed on the sterile field before insertion. Pre-testing the catheter balloon is NOT recommended If a sterile urine samples is to be collected, ensure that the sterile specimen container is open positioned for ease of access Assists with opening passage for Lidocaine 2% jelly to pass. NOTE: When jelly is cold, this may lead to spasm and the viscosity of the drug may make it difficult to flow. Instillation and dwell of the Lidocaine 2% jelly directly into the urethra allows anesthesia and dilation of the urethra before catheter insertion. Inadequate lubrication can cause urethral trauma, pain and may also result in inability to pass the catheter through the prostatic urethra. Pre-testing catheter balloon is not required. For the silicone catheter, the balloon does not return to its original shape after inflation, and the enlarged balloon area can form a cuff or crease that 'can traumatize the urethra during catheter insertion. To minimize risk of bacterial contamination during catheter insertion. At this time urine for routine microscopy, culture and sensitivity should be obtained as required per unit specific practice

10 Attachment A ACTION Hold the penis with the non-dominant hand at approximately 90 degrees to the bed; gently If mild resistance is noted while advancing the catheter, instruct the patient to cough, or bear down as if to void or perform deep breathing exercises. Then slightly rotate the catheter very gently. If this troubleshooting does not allow the catheter to pass through the urethra, do NOT continue to force the catheter. Stop Remove catheter Notify Urology Note: Do NOT force if firm resistance is met. If a urinary catheter cannot be inserted in accordance with these guidelines after 2 attempts, notify Urology. Wait for urine to drain from the end of the catheter. The lubricant gel filled distal catheter openings may delay urine return. If no spontaneous return of urine occurs within a minute of catheter insertion. 1. Ensure catheter is inserted to bifurcation 2. Ensure there is minimal catheter recoil 3. The bladder scanner may be used at this point to verify the presence of urine If urine return is still not visible after all the techniques outlined above have been utilized, withdraw the catheter and reattempt the procedure. RATIONALE To ease insertion and prevent urethral trauma. To relax the urethral sphincter, at which point the catheter is passed. Traumatic insertion can lead to the formation of a false passage, when the catheter is pushed into tissues alongside the urethra. This is a serious condition that can lead to urethral strictures, bleeding, and infection. This may require surgical intervention. Trauma to the urethra is considered a serious complication to be avoided. To ensure that the distal end of the catheter is in the bladder. Catheter irrigation is not recommended unless obstruction with clots or mucus is anticipated. Catheter irrigation solution should be instilled with gentle pressure. Vigorous irrigation and aspiration should be avoided as this can result in damage to the bladder mucosa.

11 Attachment A ACTION If the patient's foreskin has been retracted return to the normal position over the glans penis. After visualization of urine return, inflate the distal balloon by injecting sterile water through the inflation port of the catheter Insert the exact volume of sterile water indicated. Check the manufacturer's instructions on the urinary catheter package. RATIONALE Failure to reduce the foreskin can cause paraphimosis. Inflation of the balloon inside of the urethra will result in severe pain, gross hematuria and possible urethral tear. The balloon should inflate with little resistance when in the correct location. An improperly filled balloon expands asymmetrically which increases the potential for erosion of the bladder mucosa. Secure the catheter to the patient's upper thigh using a catheter stabilization device. Ensure there is no tension on the catheter. Placement of the catheter stabilizing device on the upper thigh decreases the potential for pressure necrosis, urethral erosion at the penile-scrotal junction and pistoning. Pistoning increases the risk. of bacteria transferring into the bladder as areas of catheter previously outside the b9dy travel into the urethra. Unsecured catheters can lead to bleeding, traumas, pressure sores, penile erosion, and bladder spasms from pressure and inadvertent tractions. Securement devices stabilize the catheter. Preventing tension and drag, thus reducing trauma within the urethra and bladder. Following completion of procedure ensure peri-care is completed Cover and reposition patient for comfort Dispose of used supplies Label/send any urine specimens to laboratory Proceed with Cysview reconstitution and instillation (see Cysview Reconstitution and Instillation Guidelines.

12 Attachment A Insertion of Urinary Male Catheter Criteria Checklist Critical Practice Elements Met Not Met 1. Confirms order for catheter insertion and application of Lidocaine 2% Jelly via the urethra prior to insertion of a urinary catheter. Reviews policy and procedure Two patient identifier Hand hygiene, identifies urethra and provides peri-care 2. Gathers necessary equipment. Is able to verbalize the procedure before entering the patient room. Identifies risks of insertion procedure and when to abort the procedure (i.e. unable to advance the catheter to proximal "y" shaped ports (bifurcation) and/or resistance is met. Explains procedure to patient and verifies understanding and cooperation as appropriate. Washes hands. Wears appropriate PPE. 3. Provides peri-care prior to performing procedure 4. Positions the patient for comfort and ease of access to urethral meatus. Positions bed at level comfortable working height. 5. Apply Lidocaine Jelly 2% as outlined and allow 5 minutes for anesthetizing agent to take effect. 6. Aseptic technique is maintained throughout catheter insertion procedure. Cleanses insertion site and lubricate catheter as outlined. Mound of jelly applied to meatus for insertion. 7. Discontinues procedure if resistance is met when attempting to advance urinary catheter. 8. Inserts catheter to bifurication, absence of recoil. Waits for urine to return. 9. Inflates urinary balloon with amount of sterile water specified on the urinary catheter package. 10. Peri-care completed following procedure and patient s genitalia is covered appropriately. If patient is uncircumcised, the foreskin is returned to its original position 11. Apply stabilization device to upper thigh 12. Disposes of used equipment appropriately 13. Provides patient instruction as outlined. 14. Documents in patient care record. Passed (completed / verbalized all elements above) Needs to Repeat under Direct Supervision N/A Staff Name: Validated by (print name): Unit: Unit: Signature: **Staff person to keep a copy for their own records**

13 Attachment A PROCEDURE FOR FEMALE URINARY CATHETER INSERTION using Lidocaine 2% Jelly Application of Lidocaine 2% Jelly on Females: 1. After cleansing the labia majora. Place nozzle of Lidocaine 2% jelly near the urethral orifice and apply some gel. Gently place nozzle approximating the entrance of the urethra and slowly squeeze gel onto the urethra, expel at least 5-10 ml. 2. Allow the gel to dwell for approximately 3 5 minutes, before starting catheter insertion. A sterile gauze pad may be placed over the meatus to help prevent spillage of anesthetic jelly. 3. Lubricate the tip of the catheter with Lidocaine 2% jelly and then gently slide the catheter through urethra. REFERENCES: Kasa, C., & Le, A. (2015, July 8). Retrieved December 8, 2015, from extcontent. covenanthealth. ca/policies/vii-b-1 00 _showing_ markups. pdf