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SSM HEALTH SAINT LOUIS UNIVERSITY HOSPITAL 3635 VISTA AVE SAINT LOUIS, MO 63110 April 15, 2015
VIOLATION: ADMINISTRATION OF DRUGS Tag No: A0405
Based on observation, interview, record review and policy review, the facility failed to ensure staff took measures to decrease the risks of harm when High-Alert medications (medications that bear a heightened risk of causing significant patient harm, also known as High-Risk medication) to six of six patients reviewed for High-Alert medication administration. The facility failed to ensure:
- Three patients (#3, #4 and #13) intravenous (IV, in the vein) Magnesium Sulfate and/or Potassium Chloride, (High-Alert medications, both affect muscle and nerve function and control fluid balance) medications were verified for accuracy before administration.
- Two current patients (#3 and #13) and three discharged patients (#33, #34, and #35) were administered IV High-Alert medications with the use of an infusion pump (an electronic device programmed to infuse a specific amount of medication/fluids at a set rate/time, has a low risk for unintended pump setting changes) as directed by facility policy.
- Quality audits were conducted to ensure adherence with the High-Alert medication administration policies as directed by facility policy.
These failures to conduct safety precautions to reduce the risk of patient harm from High-Alert medications had the potential to cause serious harm to all patients who received the medications. The facility census was 307.

Findings included:

1. Record review of the facility's policy titled, "Medication Management, High-Risk Medication Standards," dated 05/2014, showed the following direction:
- The purpose of the policy was to increase patient safety by avoiding preventable injuries associated with High-Risk medications and provide standardized drug safety policies for High-Alert medications as identified by the Institute for Safe Medication Practices (ISMP).
- High-Alert medication administration included an Independent Double Check process whereby a second nurse would perform an independent check verification and compare for the medication, the dose, and administration route for accuracy and document in the Medication Administration Record (MAR).
- Listed medication categories and specific medications directly from the ISMP 2014 list that included Magnesium Sulfate and Potassium Chloride.
- The Director of Pharmacy and Chief Nursing Officer were responsible for assuring all staff adhered to the policy requirements.
- The Clinical Quality Department would audit adherence to the policy in the comprehensive clinical audits.

Record review of the facility policy titled, "Medication Management - Intravenous (IV, in the vein) Administration Guidelines," dated 07/2014, showed Magnesium Sulfate, in mixtures of 1 gram (g, unit of measure) in 100 milliliters (mL, unit of measure) of solution, or 2 g in 50 mL of solution, and Potassium Chloride dosages no greater than 0.1 milliequivalent (mEq, unit of measure) in 1 mL of solution (equal to 5 mEq in 50 mL, 10 mEq in 100 mL or 20 mEq in 200 mL) were to be IV infused by infusion pump.

2. Observation on 04/14/15 at 10:20 AM showed Patient #3 with a right upper arm IV connected to IV tubing that had a manual flow regulator (IV tubing, which had a dial that was manually turned by hand to regulate the rate fluids and/or medications administered to patients, the rate could be adjusted 0-250 cubic centimeters [cc, unit of measure] per hour), attached to the tubing used to administer Magnesium Sulfate 2 g in 50 ml of solution (High-Alert medication). The patient received an IV infused High-Alert medication not administered by an infusion pump.

During an interview on 04/14/15 at 10:20 AM, Staff N, Registered Nurse (RN), assigned to provide care to Patient #3. The flow regulator device was on the IV tubing because the facility did not have an IV infusion pump available and staff often used the devices to administer IV medications and fluids. She stated that Magnesium (Sulfate) was not a High-Alert medication and she did not know of any guidelines regarding the use of infusion pumps. She further stated the flow regulator device on the patient's IV tubing was not tamper proof (the dose of medication administered could be adjusted by the patient or changed unintentionally).

Record review of the MAR for Patient #3 showed Magnesium Sulfate 2 g in 50 mL of 5 % dextrose solution administered on 04/14/15 at 8:10 AM and no independent nurse check verification was documented.

3. Observation on 04/14/15 at 10:40 AM and concurrent interview showed Patient #4 had Magnesium Sulfate 2 g in 50 mL 5 % dextrose solution infused through an IV. Staff N stated that the medication was not a High-Alert medication.

Record review of the MAR for Patient #4 showed Magnesium Sulfate 2 g in 50 ml of 5 % dextrose solution administered on 04/14/15 at 9:40 AM and no independent nurse check verification was documented.

During an interview on 04/14/15 at 10:55 AM, Staff O, Charge Nurse, stated that:
- Magnesium Sulfate was not a High-Alert medication and the facility used the flow regulators to administer IV medications because there was a shortage of infusion pumps. The shortage had been ongoing. She was unaware of guidelines for when to use IV pumps or when the use of flow regulators was not recommended. She stated that it probably was "not a good idea" to use devices like the flow regulators, which were not tamper proof, for patients who were confused.
- She was unsure what measures were in place to promote safety and reduce the risk of errors for High-Alert medications.
- The facility had a policy and procedure related to High-Alert medications (she then accessed the current policy and the ISMP 2014 list of medications, which included Magnesium Sulfate and Potassium Chloride).

During an interview on 04/15/15 at 9:20 AM, Staff SS, RN, Staff Nurse, stated that Magnesium (Sulfate) infusions were not considered a High-Alert medication at the facility.

During an interview on 04/15/15 at 10:30 AM, Staff QQ, RN, stated that the facility provided a list of medication categories and medications that were High-Risk for harm to patients. Staff QQ stated that Magnesium Sulfate and Potassium Chloride were both named as High-Alert medications. Staff QQ further stated that she would never infuse any High-Alert medication without a pump or administer without another nurse first checking it.

During an interview on 04/15/15 at 10:34 AM, Staff PP, RN, stated that Magnesium Sulfate and Potassium Chloride infusions were both High-Alert medications and all nurses should know what the High-Alert medications were and what to do before giving them. He stated that High-Alert medication administration included nurse double checks and IV infusion through pumps only. Staff PP stated that he would never administer Magnesium Sulfate intravenously without a pump.

4. Observation on 04/14/15 at 9:50 AM of Patient #13's medication administration, showed Staff V, RN connected Magnesium Sulfate 2 g in 50 mL of solution IV infusion to the IV tube with a flow regulator and failed to have another nurse perform a double check of the High-Alert medication.

During an interview on 04/14/15 at 10:10 AM, Staff V stated that Magnesium Sulfate was not a High-Alert medication here (at this facility) and that it was okay to administer the medication without a controlled IV pump machine and that she did not have to do a double check with another nurse.

During an interview on 04/15/15 at 10:55 AM Staff NN, Pharmacist stated that Magnesium Sulfate was not a High-Alert medication,

5. Record review of "Patient Safety Events" showed the following labeled as medication events (errors, or potential errors, made in the process of medication administration):
- On 12/22/14, Patient #33 received an "overdose" of IV fluids containing 20 mEq of Potassium Chloride, infused through a flow regulator, but "should have hung on pump, because it had potassium in it". The fluids with the Potassium Chloride "ran over 2 hours on accident, instead of setting [flow regulator] to 75" (75 cc's per hour, which indicated that it should have infused over approximately 12 hours). The patient required an Electrocardiogram (EKG, tests the heart's electrical activity for abnormality), laboratory blood tests and was placed on a telemetry monitor (used to continuously monitor the heart's electrical activity for abnormality).
- On 02/04/15, Patient #34 was found with Potassium Chloride running on a flow regulator, so the infusion was stopped and a infusion pump was ordered. The event was labeled as "wrong administration route".
- On 02/12/15, Patient #35 was admitted from the Emergency Department with "Potassium [Chloride] hooked up to a (flow regulator)", so the tubing was clamped, removed, and replaced with tubing compatible to complete the infusion on a infusion pump. Further documentation showed that the nurse who had placed the Potassium [Chloride] on the flow regulator, was "not familiar with this requirement", which indicated that the infusion should have been on an infusion pump. The event was labeled as "wrong administration route".

During an interview on 04/14/15 at 11:15 AM, Staff P, Director of In-Patient Services, stated that Magnesium Sulfate was not a High-Alert medication and the facility did not have guidelines related to the use of administration. Due to an infusion pump shortage, flow regulator devices were used for administering IV medications and fluids.

During an interview on 04/15/15 at 1:40 PM, Staff W, Director of Pharmacy, stated "We did a review of literature to determine whether Magnesium [Sulfate] and Potassium [Chloride] should be infused on a [infusion pump]" and "it is our [Pharmacy and Therapeutics Committee] recommendation to infuse Potassium [Chloride] and Magnesium [Sulfate] on a [infusion pump]".

During an interview on 04/15/15 at 4:02 PM, Staff J, Chief Nursing Officer, stated that:
- He was not aware that Potassium Chloride or Magnesium Sulfate required infusion by infusion pump;
- He was not aware of any education provided to nursing staff related to concentrated electrolyte infusions, such as Magnesium Chloride and Potassium Sulfate;
- He relied upon pharmacy and risk management for trends in medication errors, such as failure to utilize a infusion pump to be brought to his attention.

During an interview on 04/15/15 at 4:15 PM, Staff W, Director of Pharmacy, stated that no compliance audits related to High-Alert medication administration were conducted in the pharmacy department.

During an interview on 04/15/15 at about 3:50 PM, Staff TT, Chief Quality Officer, stated that no quality audits had been conducted to ensure clinical compliance with the safe administration of High-Alert medication.