Preventing the Use of Incorrect Dialysate or Dialyzer

1. Preventing the Use of Incorrect Dialysate or Dialyzer Is Key to Keeping Kidney Patients Safe

2. Incorrect Dialysate or Dialyzer • Setting up the wrong dialyzer or dialysate for a patient can be a dangerous event that can result in harm to patients. • Prevention of these errors requires patient and professional education and procedural safeguards. • Increasing patient involvement in dialysis care and safety issues may provide another approach to preventing errors.

3. Dialysate Background • The first step in dialysate production is rigorous preparation of water. • The product water is then mixed with both an acid concentrate and a bicarbonate solution. • Provider orders control the exact dialysate composition.

4. Dialysate Error Example • 54 year old hemodialysis patient had breathlessness, vomiting, fever and a seizure • Found to have severe acidosis- pH 6.65, serum bicarbonate 3.5 • Root cause- Incorrect mixing of bicarbonate fluids • Patient recovered • Bhosale GP, Shah VR. Successful recovery from iatrogenic severe hypernatremia and severe metabolic acidosis resulting from accidental use of inappropriate bicarbonate concentrate for hemodialysis treatment. Saudi J. Kidney Dis Transpl. 2015 Jan;26(1):107-10

5. Incorrect Dialyzer or Dialysate Solutions • Davenport A. Complications of hemodialysis treatments due to dialysate contamination and composition errors. Hemodial Int. 2015 Oct;19 Suppl 3:S30-3 • Components of the dialysis prescription include treatment duration, model and size of dialyzer, blood flow rate, and dialysate flow rate. • It should also include reference to dialysate composition (e.g., sodium, potassium, calcium, and bicarbonate concentrations). • Deviation from the prescription can result in injury to the patient.

6. Facts about Incorrect Dialyzer or Dialysate Solutions • 6 Dialysis machine safety monitors cannot prevent adverse events. They can only detect adverse events and mitigate the related harm.

7. Errors in Hemodialysis • Approximately 14% of hemodialysis adverse events are related to dialysis prescription including dialysate and filter mistakes • Incorrect diaysate or dialyzer are considered among the most common hemodialysis errors • Arenas Jiménez MD, Ferre G, Álvarez-Ude F. Strategies to increase patient safety in Hemodialysis: Application of the modal analysis system of errors and effects (FEMA system). Nefrologia. 2017 Nov - Dec; 37(6):608-621

8. Factors Contributing to Incorrect Dialyzer or Dialysate • Use of wrong size or type of dialyzer. • Incompatibility - the use of mismatched concentrates in a particular bicarbonate delivery system. • Crossed or improper connections can result in problems ranging from dialysate compositions that differ from the prescribed formulation to dialysates that prove fatal. Delivery of acid concentrate alone can be fatal, depending on the proportioning system used and the alarm limits of the dialysis machine.

9. Mechanical Factors Leading to Dialysis Errors • Ruptured dialyzer • Clotted dialyzer • Air embolism • High conductivity • Low conductivity • Low water pressure • High venous pressure

10. Factors that may Contribute to Use of Incorrect Dialyzer or Dialysate • Inexperienced or undereducated staff • Insufficient staff to handle work load • Lack of counseling when procedures are not followed • Staff discomfort with reporting medical errors • High rate of staff turnover • Lack of effective Performance Improvement program • Lack of patient education about their care

11. Preventing Dialysate Errors • Check the pH and conductivity of the dialysate, as well as the conductivity, pH, and temperature alarm systems, before each dialysis treatment. Checks of proper concentrate, conductivity, and pH should be included in the pretreatment check of all components and alarm systems of the dialysis machine. • Make sure that all staff are aware of the types of dialysate concentrates available, even if you currently use only one type. Be sure that this information is included in the orientation program for new employees. Institute an ongoing educational program to keep employees informed of developments in all areas of dialysis treatment. • Whenever possible, use a system of labeling connectors and containers that prevents or minimizes crossed connections and use of mismatched concentrates. When ordering solutions, request that such systems be incorporated (e.g., color coding, different connectors) in delivered products, not shipped separately.

12. Preventing Dialysate Errors • Store and dispense dialysate concentrates as though they were drugs. Develop a policy, management, and storage system that will effectively control the mixing and dispensing of all concentrates. • Double-check and record concentrate formulas on the patient's record. Consider a procedure for countersigning patient and storage records. • Do not dispense concentrates from large containers into smaller ones without a "keyed" dispensing system. Whenever possible, purchase concentrates in single-treatment (2½-gallon) containers. • Always dispose of concentrates remaining from the previous treatment. Do not pour remaining concentrate into another container or use in the next treatment. Replace empty or partially full containers with full ones.

13. Preventing Dialysate Errors • Measure the delivered dose of HD at regular intervals to ensure adequacy. • Assign patients on re-use their own personal dialyzer with their name and birth date on it. • Verify the dialyzer volume. Dialyzers intended for reuse should have a blood compartment volume not less than 80% of the original measured volume or a urea (or ionic) clearance not less than 90% of the original measured clearance.1 1. KDOQI Clinical Practice Guidelines and Clinical Practice Recommendations. 2006 Updates.

14. Preventing Dialyzer Reuse Errors • Clearly label the dialyzer with the patient’s name. Use the dialyzer only used for the same patient. • Test the dialyzer after each use to make sure it is working properly. • Test the dialyzer after rinsing and before patient is connected to venous and arterial lines for any traces of disinfectant that may remain. • Learn the possible signs and symptoms of reactions due to reuse and monitor patients for those reactions. Monitor patients for any reactions due to reuse.

15. Correcting Incorrect Dialyzer in a Reuse Setting • Turn off blood pump immediately when error is noted. • Clamp both arterial and venous needle lines with hemostats. • Clamp both arterial and venous bloodlines. • Disconnect both bloodlines from needle lines. • Discard all blood lines, and everything but the dialyzer used in association with the incorrect dialyzer. • Flush both arterial and venous needles with 10cc of Normal Saline leaving syringes attached to needles. • Re-set up machine for patient using appropriate dialyzer per proper procedure. • Document incident in CV4. • Complete incident report. • Have patients complete a HIV consent form. • Draw the following lab work: Hepatitis Panel, (both B and C) and a HIV on both patients. NOTE: Return the dialyzer to reprocessing.

16. Best Practices for Preventing Dialyzer or Dialysate Errors • Develop a culture of safety and encourage a safe environment • Implement a system for anonymously reporting “near misses” • Perform root cause analyses on near misses and adverse events, then follow the occurrences of these events in the facility's QAPI safety program. • Review existing policies and procedures • Verify in writing prescribed dialyzer type is used every treatment • Verify in writing prescribed dialysate is used every treatment • Maintain prescribed blood flow rate throughout entire treatment or arrange for adding the time spent at a lower than prescribed blood flow rate to subsequent dialysis treatments • Develop standardized systems • Develop patient safety plan • Establish system for reporting errors See PATIENT SAFETY IMPROVEMENT PLAN BASICS for more info!

17. Checklist for Preventing Use of Incorrect Dialyzer or Dialysate • Two staff members independently check and initial the dialyzer and dialysate. • The patient checks and initials dialyzer and dialysate. Patients, educated on the dialysis procedure, dialysate and labs (connection between their potassium level and dialysate), will be able to identify if the wrong potassium bath is being used. (Staff should provide dialysis prescription updates to patients.) • Staff and patients are educated on the dialysis treatment/procedure, explaining each step in the process, including what each identified area on the panel means, e.g., UFR, BFR, etc. • Staff check the blood flow rate on the machine to make sure it matches what was ordered. • Staff check the dialysate flow rate on the machine. A decrease in dialysate flow decreases toxin removal. • If the facility reuses the dialyzer, staff check the “fill volume.”

18. Developing Policies and Procedures • Review current policies and procedures to ensure they meet current recommendations for preventing errors and adverse events. • Review CMS Conditions for Coverage for ESRD Facilities. • Review examples of Quality Assessment and Performance Improvement (QAPI) projects and develop QAPI projects appropriate for your facility.

19. Value of Standardized Systems • Standardized systems reduce opportunities for error. • Human errors can be caused by multiple factors. • Standardizing processes and systems minimizes the possibility for errors due to the human limitations that even the most vigilant professional can have. • Standardized systems will give staff the strength to decrease variation in patient care and, ultimately, improve safety.

20. Develop System for Reporting Errors/Adverse Events • All staff—clinical, clerical, housekeeping, and maintenance—as well as patients, need specific, written directions on how to report errors or adverse events. • There should be discussions to ensure that all team members clearly know what staff is responsible for responding to errors and near misses immediately. • A reporting form should be created for documentation.

21. Conduct Root Cause Analyses • Every wrong dialysate or dialyzer event should lead to a “huddle” to discuss what went wrong and how to prevent future episodes • For more serious events the facility should conduct a root cause analysis.

22. What are common causes of dialyzer or dialysate errors? • Unlabeled dialyzer • High conductivity • Low conductivity • Insufficient Staff • All of the above

23. What are common causes of dialyzer or dialysate errors? • Unlabeled dialyzer • High conductivity • Low conductivity • Insufficient Staff • All of the above

24. TRUE OR FALSE It’s important to test the dialyzer after each use to make sure it is working properly.

25. TRUE OR FALSE It’s important to test the dialyzer after each use to make sure it is working properly. TRUE

26. Additional Resources • Maintaining safety in the dialysis facility. Kliger AS.Clin J Am SocNephrol. 2015 Apr 7;10(4):688-95. Available at www.ncbi.nlm.nih.gov/pubmed/25376767 • Complications of hemodialysis treatments due to dialysate contamination and composition errors. Davenport A. Hemodial Int. 2015 Oct;19 Suppl 3:S30-3. Available at www.ncbi.nlm.nih.gov/pubmed/26448385 • Dialysis Safety: What Patients Need to Know http://www.renalmd.org/mpage/Patient_safety_tools

27. Additional Resources • CDC Dialysis Safety Checklists www.cdc.gov/dialysis/coalition/resource.html • Cause Analysis Tools, American Society for Quality www.asq.org/learn-about-quality/cause-analysis-tools/overview/fishbone.html • HDCN Quiz:  Basics of dialyzer function: Extraction ratio and clearance www.hdcn.com/quizzer/adeq/er21/doorway.html