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Based on observation, interview, and record review, the facility's Governing Body failed to ensure contracted dialysis staff implemented their policy and procedures in that 2 of 6 hemodialysis patients observed:

1) Unlicensed staff were adding potassium powder to hemodialysis concentrate used to dialyze patients.

2) Registered nurse failed to confirm dialysis prescription in that the correct concentrate prescribed by the physician was not calibrated into the dialysis machine to mix the concentrate prescribed by the physician.

3) Dialysate concentrate prescribed and dialysate concentrate selected for use during treatment did not match

4) Dialysate containers were not labeled with the final concentrate, signature of the individual who prepared the concentrate, the date/time and the additive electrolyte.

This practice has the potential for putting all individuals at risk who are receiving hemodialysis for injury or death. Potassium is a major cause of death in dialysis patients. Potassium is needed to keep the nerves, muscles, and heart working well. Low or high potassium can cause irregular heartbeats and may cause the heart to stop beating.


Findings:

Policy and Procedure Reviewed:

Dialysis Additives

Review on 1/6/2020 at 3:00 PM of the dialysis contract company's policy and procedure for ID #M, titled "Additives - Mixing Spikes", Department: Dialysis Services, Reference #2073, Revised July 2016. Definition: Manufacturers provide acid concentrates with a wide range of electrolyte compositions for different proportioning ratios. Most typical dialysate prescriptions can be obtained by using one or more of these commercially available concentrates. If particular formulations are not available, manufactures provide additives that can be used to adjust the level of potassium or calcium in the dialysate. These additives are commonly referred to as "spikes."

Policy: When additives are used to increase concentrations of specific electrolytes in the acid mixing procedures shall be followed as specified by the additive manufacturer. When spikes are used, manufacturer's directions shall be followed.

Additives shall be labeled correctly to include: The added electrolyte, date and time added, name of the licensed person making the addition. Containers shall be labeled to indicate the final concentration of the added electrolyte. Labels should be affixed to the containers when the mixing process begins.

When additives are prescribed for a specific patient, the container holding the prescribed acid concentrate shall be labeled with: The name of the patient, the final concentration of the added electrolyte, the date on which the prescribed concentrate was made, the name of the person who mixed the additive.


Nursing Oversight of Care by the Patient Care Technician

Review on 1/7/2019 at 11:00 a.m. of current policy and procedure from contracted dialysis provider ID #M. Subject: Nursing oversight During Provision of Care by the Patient Care Technician Acute Services, Reference # PC-7118, Revised 06/2019.

Purpose: To provide guidance for direct supervision of services provided in the inpatient acute care setting by the dialysis Patient Care Technician (PCT).

Policy: The Dialysis Registered Nurse (RN) shall be responsible for the direct supervision of the dialysis Patient Care Technicians performing dialysis treatments in the acute setting.

Procedure/Oversight Model: Prior to initiation of dialysis the Dialysis RN shall: Confirm the physician's dialysis orders from the nephrology team and review the patient's lab. Review the machine settings performed by the Patient Care Technician to confirm the setting corresponds to physician's dialysis orders. Administer any prescribed medications to be given during the dialysis as prescribed by the Nephrologist team.


Review of the Manufacturer's Operators Manual 2008 rev. K +, directs users as follows:

"The specific acid and bicarbonate concentrates, including the sodium, bicarbonate, and electrolyte compositions, must be prescribed by a physician. Warning! Many concentrate types are available for use in dialysate delivery machines. Concentrates contain various amounts of dextrose, potassium, calcium, sodium, chloride, magnesium, and other components. Most concentrates are designed as a two-part system of acid and bicarbonate solutions which are mixed in the machine with water. Even within the subgroup of bicarbonate type concentrates, there are at least four methods of compounding the solutions. Each of these methods requires special calibrations or setups. Certain methods are not supported.

It is mandatory that the acid and bicarbonate types be matched to each other. Be sure to use compatible solutions, labeling, and setups. These setups include machine calibration, special adapters for certain concentrate types, correct setting of concentrate option and labeling.

Failure to use the properly matched solutions and machine calibrations may allow improper dialysate to be delivered to the patient, resulting in patient injury or death. Verify composition, conductivity, and pH after converting to a different type of concentrate."


Observation:

Patient ID #1 Fresenius 2000 K Hemodialysis Machine #7KOS115396

On 01/06/2020, at 9:40 AM, along with Chief Clinical Officer, Employee ID #C, Patient #1 was observed in room #309 receiving hemodialysis by dialysis patient care technician (PCT) Employee ID #D.

Review of the physician's orders located in the printed medical record revealed the following: hemodialysis treatment via CVC (central venous catheter) at a blood flow rate 350 mls/minute and dialysate flow rate of 700 ml/minute using an Optiflux 160 dialyzer with a dialysate concentrate of 3.0 potassium and 2.5 calcium.

Observation of the dialysis concentrate container being utilized during the hemodialysis treatment revealed a manufactures label for 2.0 potassium and 2.5 calcium and had the patient's medical record label attached. The dialysis concentrate did not have any additional labeling to indicate potassium additive had been mixed to increase the concentrate to a 3.0 potassium.

During an interview on 1/06/2019, at 9:40 AM, PCT Employee ID #D was asked what concentrate of potassium was in the dialysate container. Employee ID #C stated, the solution was a 3.0 potassium. Employee ID #D was asked who was responsible for mixing the electrolyte additive to the dialysate concentrate. Employee ID #D replied, he was responsible and that he had added 1 gram of potassium additive to the bath to make the dialysate concentrate a 3.0 potassium. Employee ID #D confirmed, he had not properly labeled the solution with the required information and he was unaware that he could not add additives to the dialysis concentrate that only a licensed nurse could.


Observation of the concentrate setting on the machine revealed the hemodialysis dialysate setting was set for a 2.0 potassium and 2.5 calcium solution. Employee ID #C was asked why the concentrate on the machine and the delivered prescribed bath do not match. Employee ID #D replied, there was no selection for a 3.0 potassium bath on the drop-down dialysate selection menu on the hemodialysis machine. Employee ID #D opened the dialysate selection and it was observed that a 3.0 potassium, 2.5 calcium bath was available to be selected.


Patient ID #3 Fresenius 2000 K hemodialysis machine #7KOS113267

On 01/06/2020, at 10:05 AM, along with Chief Clinical Officer, Employee ID #C, Patient #3 was observed in room #319 receiving hemodialysis by dialysis patient care technician (PCT) Employee ID #G.


Review of the physician's orders located in the printed medical record revealed the following: hemodialysis treatment via a CVC (central venous catheter) at a blood flow rate 400 mls/minute and dialysate flow rate of 800 ml/ minute using an Optiflux 160 dialyzer with a dialysate concentrate of 3.0 potassium and 2.5 calcium.

Observation of the dialysis concentrate container being utilized during the hemodialysis treatment revealed a manufactures label for 2.0 potassium and 2.5 calcium and had the patient's medical record label attached. The dialysis concentrate did not have any additional labeling to indicate potassium additive had been mixed to increase the concentrate to a 3.0 potassium.

During an interview on 1/06/2020, at 10:05 AM, Employee ID #G was asked what concentrate of potassium was in the dialysate container. Employee ID #G stated, the solution was a 3.0 potassium. Employee ID #G was asked who was responsible for mixing the electrolyte additive to the dialysate concentrate. Employee ID #G confirmed that the PCT was responsible and she had added 1 gram of potassium additive to the dialysate solution to make the concentrate a 3.0 potassium solution. Employee ID #G confirmed, she had not properly labeled the solution with the required information and that she was unaware that she should not add additives to the dialysis concentration that only a licensed nurse could do that.


Interview on 1/6/2020, at 10:20 AM, with supervising dialysis nurse Employee ID #H confirmed, the dialysis machine used for hemodialysis on Patient ID #1 and Patient ID #3 did not have the correct dialysate concentration selected and the dialysate containers with the potassium additive were not labeled properly.


Employee ID #H confirmed, she did not mix the potassium additive for patient ID#s 1 & 3. Employee ID #H confirmed, the special baths had been mixed by the non-licensed dialysis patient care technicians and was unaware that a patient care technician could not add additives to the dialysis concentrate only a licensed nurse could.

Employee ID #H was asked if she had confirmed the dialysis machines for Patient ID#s 1 & 3 had the correct dialysis prescription and Employee ID #H stated that she had verified the correct dialysis solution, dialyzer, blood pump speed, and dialysis flow rate but did not check the dialysate setting in the machine for the correct concentrate.


Interview on 1/6/2020, at 3:30 PM, with Director of Operations for contract dialysis Company M, Employee ID #F stated that the staff are educated on the dialysate additives and know that only a licensed nurse can mix the additive in the dialysis solution.

Employee ID #F acknowledged that the licensed nurse is responsible for direct supervision of the patient care technicians (PCT) and should have confirmed what was entered into the dialysis machine was what was ordered by the physician. Employee ID #F stated, the nurse should have confirmed the Nephrologist's dialysis orders and the prescription matched what was set on the machine including the dialysate concentration.

Employee ID #F stated that not all the special dialysis baths were available for selection in all the dialysis machines. Employee ID #F stated he would have his machine technicians come out and enter them into the dialysis machines today.