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Based on observation, interview and record review, the Facility's Governing Body failed to ensure that contracted hemodialysis staff providing hemodialysis treatment to the facility's patients did so in a safe manner in that they did not confirm dialysate concentrate setting on the hemodialysis machine, arterial chambers were less than 75% of full and patient's dialysis accesses were not visible.

Findings:

Review of the Manufacturer's Operators Manual 2008 rev. K +, directs users as follows: "Check to see if: Alarm Dialysate flow is on. The correct concentrate is selected in the "Dialysate" screen and the concentrate lines are connected to appropriate concentrate. The prescribed concentrate and the correct baseline Na Bicarbonate values are displayed in the "Dialysate" screen. The supply of concentrate is adequate. The concentrate has been mixed properly, (i.e. bicarbonate mixed well with RO water)."

Review of the manufacturer's directions for use directs the user as follows: "General Warnings and Precautions...9. Maintain drip chamber level at ¾ full to help prevent drip chamber evacuation, causing a possible air embolus. Full drip chamber levels can result in stagnation of blood in the upper portion of the drip chamber, resulting in clotting..."

Review of the facility's procedure titled, "Machine Start Up and Priming a Non-ETO Sterilized Single Use Dialyzer Utilizing Fresenius 2008 Series Dialysis Delivery Systems and Nipro or Combiset Blood Lines for First Shift of the Day," dated 6/2017, indicated,"...20. When the arterial drip chamber is approximately ¾ full or at the manufacturer's fill line indicator, tighten the cap and re-clamp the line."

Review of the facility's current Policy and Procedure, #1 Policy:7-05-03, "Titled Intradialytic Treatment Monitoring", reads in part .....
Policy: 4. Patient(s) are to be monitored by a healthcare provider visually and audibly at all times. Patient(s) are not to be left unattended. 5. The patient(s) vascular access site and the blood line connections needs to be continuously visible throughout the dialysis treatment. Allowing patients to cover access sites and line connections provides an opportunity for accidental needle dislodgement or a line disconnection to go undetected. 6. The arterial and venous drip chamber levels should be observed and adjusted as needed.


Patient ID #4 hemodialysis machine #9KOS-142756 (6)

On 08/2/2018 at 10:30 a.m. along with Quality Director, employee ID# 60 revealed Patient #4 was observed in ICU room #240 receiving dialysis. The Patient was utilizing hemodialysis machine Fresenius 2008 K 2, machine ID #9KOS-142756 (6). Patient ID #4 was receiving hemodialysis treatment via a right CVC (central venous catheter) at a blood flow rate 300 mls/ minute and dialysate flow rate of 800 ml/ minute using a Revaclear dialyzer, a dialysate concentrate of 2.5 potassium and 2.5 calcium. Patient's dialysis access site and blood line connection was observed to be covered by a blanket.

Observation of the setting on the dialysate machine, revealed the hemodialysis machine was set for dialysate concentrate 2.0 potassium 2.5 calcium. The Patient was utilizing 2.5 potassium, 2.5 calcium dialysate concentrate.

During an interview on 08/02/2018 at 10:35 a.m. dialysis RN (Registered Nurse) ID #57 was asked why the concentrate on the machine and the delivered prescribed bath do not match. The Dialysis RN ID #replied there was no selection for a 2.5 potassium bath on the drop down selection menu on the machine. She stated we just have a 2.0 potassium and a 3.0 potassium selection. Dialysis RN ID #57 was asked if she knew if additional dialysate concentrates could be added. Employee stated she did not know that and would talk to her manager about adding it. Dialysis RN ID #57 was asked if the patient's dialysis access should be covered, she replied "No, it should not" and she immediately uncovered the access.

Interview with Dialysis Nurse Manager ID #59 on 8/2/18 along with Quality Director, employee ID #60 was asked if it was acceptable if the dialysate used during the treatments did not match what was selected on the hemodialysis machine. Employee ID #60 stated the dialysate used and the machine dialysate concentration should match. Employee ID #59 was asked if she was aware there was no 2.5 Potassium, 2.5 Calcium on the selection screen and staff were selecting the 2.0 Potassium, 2.5 Calcium bath to be used. Employee ID # 60 stated, no she was not aware and she would check with the biomedical department and have them correct it.

During further interview with the Dialysis Nurse Manger ID #59 was asked if it was acceptable to have the access covered during the treatment. Employee ID # 59 replied, "The access should be visible at all times and not covered."

Review of the Patient's treatment sheet revealed the Patient ID #4 began his hemodialysis treatment at 9:30 a.m.


Patient #3 Hemodialysis Machine #9K0S-142895 (05)

Observation on 08/02/2018 at 10:15 a.m. along with employee ID# 60, Quality Coordinator revealed Patient #3 was observed receiving hemodialysis treatment in ICU room #238 by Dialysis RN #58, utilizing hemodialysis machine # OK0S-142895 (05), a Fresenius 2008 K 2 machine with Nipro external blood lines. The Patient was receiving hemodialysis treatment at a blood flow rate of 250 mls/ minute and dialysate flow rate of 0 mls/minute set for PUF (pure ultrafiltration) for 2 liters, via a left CVC (central venous catheter) and using a Revaclear dialyzer. Observation revealed the arterial chamber of the external blood line was 1/3 full with blood running down the side of the chamber.

Interview 08/02/2018 at 10:20 a.m. the Dialysis RN ID #58 was asked if it was acceptable for the arterial drip chamber to be only 1/3 full. Dialysis RN ID #51 replied, "No, it should be higher." Employee ID #58 was then seen raising arterial drip chamber to ¾ level.

Review of Patient's treatment sheet revealed the Patient ID # 3 began her hemodialysis treatment at 7:45 a.m.


Patient ID #7 hemodialysis machine #9K0S-142895 (05)

Observation on 08/20/2018 at 14:00 p.m. along with Quality Coordinator employee ID #60 revealed Patient #7 was observed receiving hemodialysis treatment in ICU room #234 by Dialysis RN ID #58, utilizing hemodialysis
Machine #9K0S-142895 (05) a Fresenius 2008 K 2 machine with Nipro external blood lines. Patient was receiving hemodialysis treatment at a blood flow rate of 250 mls/ minute and dialysate flow rate of 0 mls/minute PUF (pure ultrafiltration) via a left subclavian CVC (central venous catheter). Observation revealed the arterial chamber of the external blood line was 1/2 full with blood running down the side of the chamber.

On 08/2/2018 at 14:05 p.m. Dialysis RN ID #58 was asked if the arterial blood chamber level was OK. Dialysis RN ID #58 replied "No, it needs to be raised, I will raise it."

Review of Patient's treatment sheet revealed the Patient ID #7 began her hemodialysis treatment at 12:35 p.m.


Patient #2 hemodialysis machine #0K05-153524 (07)

Observation on 08/2/2018 at 10:00 a.m. along with Quality Coordinator revealed Patient #2 receiving hemodialysis treatment in ICU room 238 by Dialysis RN ID #51, utilizing hemodialysis machine #0K05-153524 (07), a Fresenius 2008 K 2 machine with Nipro external blood lines. Patient was receiving hemodialysis treatment via a right CVC (central venous catheter) at a blood flow rate of 300 mls/ minute and dialysate flow rate of 600 mls/ minute on a Revaclear dialyzer. CVC was observed to be covered with a sheet and not visible to Dialysis RN ID #51.

On 08/2/2018 at 10:05 a.m. Dialysis RN ID #51 was asked if it was OK to have the patient's dialysis access covered, she replied "No, it should be uncovered so we can see it." Dialysis was then observed immediately pulling removing cover from the patient's access."

Review of the Patient's treatment sheet revealed the Patient ID #2 began his hemodialysis treatment at 9:00 a.m.