CRRT Complications and Troubleshooting

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CRRT Complications and Troubleshooting

• Sheldon Tobe,
• Sunnybrook Health Sciences Centre

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Objectives

• At the end of this presentation, the health care
  provider will be able to
• List the potential errors associated with
  pharmacy prepared solutions
• Review actual errors associated with CRRT
  solutions that have occurred in different
  institutions
• Apply the information to a case study

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CAN YOU IDENTIFY POTENTIAL FOR ERROR?
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Potential for Errors in CRRT

• Physician errors when using non standard orders
  for dialysate or replacement solutions
• Nursing administration errors in choice of
  solutions
• Pharmacy transcription errors in dialysate orders
• Pharmacy calculation errors in compounding
• Pharmacy product selection errors in compounding

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NEED FOR STANDARD ORDERS
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Administration Errors

• Confusion of calcium chloride infusion bags for
  sodium bicarbonate replacement solution bags
• Labeling of calcium chloride infusion bags with
  bright fluorescent stickers by pharmacy
• Separation of replacement fluids from calcium
  chloride bags in separate bins

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Administration Errors

• Nursing mixed concentrated Normocarb dialysate
  with normal saline instead of sterile water
• Pharmacy mixing of Normocarb?

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Dialysate Compounding Errors

• Foothills Medical Centre, Calgary Health Region
• 83 yo female in CV ICU died suddenly in the
  presence of family and physicians
• ICU physician suspected dialysate used for CRRT
• An analysis of dialysate solutions revealed
  potassium chloride was used in place of sodium
  chloride
• Attributed to another death that occurred one
  week prior

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Foothills Medical Centre, CHR

• 3 liter bags prepared in batches of 36 bags
• Dialysate concn Na 110 mEq/L, Mg 0.7 mEq/L
• Prepared by 4 pharmacy technicians involved in
  setup and documentation, checking of setup,
  product transfer, final check
• No empty bottle verification against worksheet
• No pharmacist check of final product

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Foothills Medical Centre, CHR

• At FMC, 34 of the pharmacy staff were
  pharmacists
• National averages are 44 pharmacists
• Tech check tech delegation endorsed by CSHP
• Over delegation of pharmacist responsibilities?

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CHR Recommendations

• The feasibility of using commercially prepared
  dialysate solutions be explored.
• When patient care issues necessitate that
  in-house manufacturing of complex preparations be
  undertaken, process mapping be used to simplify
  the processes as much as possible.

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FDA Labeling Changes

• Death due to the accidental misadministration of
  concentrated KCl Injection led to
• Changing the official USP name to Potassium
  Chloride for Injection Concentrate (emphasis
  added)
• Labels must now bear a boxed warning
  "Concentrate Must be Diluted Before Use"
• The cap must be black in color (the use of black
  caps is restricted to this drug product only)
• The cap must be imprinted in a contrasting color
  with the words, "Must be Diluted."

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Different Perspectives

• According to ISMP survey, 91 nurses vs 98
  pharmacists consider IV KCL to be a high alert
  medication
• 73 nurses vs 94 pharmacists consider hypertonic
  sodium chloride inj to be a high alert medication

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Time Requirements

• Pharmacy needs advanced notice to prepare
  dialysate, replacement fluids, calcium chloride,
  citrate infusions
• Often the same patient requires pressors that
  need to be mixed by pharmacy
• Daily rounding and ordering of solutions by ICU
  pharmacist to determine need

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USP 797

• Immediate Use Exemption from ISO Class 5 (Class
  100)
• Three or fewer sterile products may be prepared
  in worse than ISO Class 5 air when there is no
  direct contact contamination, and administration
  begins within 1 hour and is completed within 12
  hours of preparation.

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USP 797

• Need for aseptic preparation?
• IHD data on bicarbonate dialysate
• Bacterial growth and endotoxin production
• Sterile versus non sterile dialysate
• IL 1 production
• Interleukin hypothesis

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Water and Dialysate Quality
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Case Study

• What happened?
• Analysis of the replacement fluid revealed that
  the NaHCO3 was never placed in the solution and
  the total Na was 105 mEq/L

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Case Study

• Root Cause Analysis
• Why was sodium bicarbonate not added to the
  solution?
• Are the replacement solutions prepared in batches
  or on a patient by patient basis?
• What is the process for pharmacy set-up,
  preparation, final check and documentation?
• Are the products and syringes made available for
  final check?
• Is the pharmacist involved in checking the final
  product?

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Extemporaneous Compounded Solutions
mEq/L unless otherwise stated
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Comparison of Commercial Dialysate
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Recommendations

• Use commercially available products whenever
  feasible
• Standard physicians orders for CRRT solutions
• Separate look alike drugs in the pharmacy
• Ensure process for pharmacy prepared solutions is
  mapped out
• Ensure pharmacist is the final check!
• Training, training, training!
• Label and separate solutions at the bedside in
  appropriate bins