Fresenius Medical Care Kanawha County

“IC-HANDLING INFECTIOUS WASTE CFR(s): 494.30(a)(4)(i) [The facility must demonstrate that it follows standard infection control precautions by implementing-] (4) And maintaining procedures, in accordance with applicable State and local laws and accepted public health procedures, for the- (i) Handling, storage and disposal of potentially infectious waste; This Standard is not met as evidenced by: 38282 Based on observation, document review, and staff interview, the facility failed to follow their policy for disposal of contaminated sharps for one (1) of one (1) patient observed getting pre-treatment labs drawn from a fistula. This failure has the potential to adversely affect all patients having labs drawn at the facility. Findings are as follows: An observation was conducted on 03/19/24 starting at 10:25 p.m. at station #13 of the treatment area of an access of an arteriovenous fistula (AVF). Employee # 2 had accessed the fistula in preparation for starting dialysis. Employee #2 then accessed the venous port with a vacutainer needle holder and drew a tube of blood for pre-treatment labs. Following the lab draw, Employee #2 was observed dropping the vacutainer needle holder into a plastic bag of trash that was taped on the edge of the patient’s chair tray. The vacutainer holder contained a needle contaminated with blood and was not placed in a sharps container. A review of the policy, titled “Drawing Blood Work Pre-Treatment from an AVF/AVG [arteriovenous fistula/arteriovenous graft] or Catheter” published 05/02/22 stated, in part, “8. After all blood tubes are filled and removed from vacutainer, clamp catheter and remove adapter and needle holder. Discard vacutainer needle holder with the needle intact in a sharps container as soon as feasible.” An interview was conducted on 03/19/24 at 2:00 p.m. with Employee #2, who confirmed that the vacutainer needle holder was discarded in the regular trash but should have been placed in the sharps container. An interview was conducted on 03/19/23 at 3:15 p.m. with Employee #1, who confirmed that all vacutainer needle holders were to be placed in the sharps container following use per the facility policy.”

“PE-EQUIPMENT MAINTENANCE-MANUFACTURER’S DFU CFR(s): 494.60(b) The dialysis facility must implement and maintain a program to ensure that all equipment (including emergency equipment, dialysis machines and equipment, and the water treatment system) are maintained and operated in accordance with the manufacturer’s recommendations. This Standard is not met as evidenced by: 38282 Based on observation, document review, and staff interview, the facility failed to schedule and assign responsible staff to clean the acid room. This failure has the potential to adversely affect all patients receiving treatment at the facility. An observation was conducted on 03/19/23 starting at 1:30 p.m. of the acid room. The room had an acid tank located on the left side of the room and two (2) bio carbon tanks on the right side of the room. The left wall beside the acid tank had splashes of dried white sediment halfway up the wall. There were dried white sediment stains on the tank, and thick clumps of white sediment on the pipes and valves leading to the tank. There was a bucket of liquid rimmed with large clumps of white sediment around the rim. The floor on the right side and behind the two (2) bio carbon tanks had standing liquid, with no discernable leak identified. Outside the door to the acid room above the door, there was a dry erase board calendar with a cleaning schedule for every Thursday; dated August 2022. A review of the policy, titled “General Cleanliness and Infection Control Guidelines” published 02/07/22, stated in part, “All areas must be kept clean and organized, including but not limited to ... water supply room ...” And: “Facility staff are accountable for cleaning rooms/areas not assigned to contract cleaning staff. Such cleaning should be done regularly using a schedule developed by the facility.” An interview was conducted on 03/19/24 at 2:10 p.m. with Employee #2 regarding cleaning the acid room. Employee #2 stated, “We make acid on Tuesday, Thursday, and Saturday. We clean the room with RO [reverse osmosis] water, but it isn’t a scheduled routine duty or documented anywhere.” Regarding the standing liquid behind the bio carbon tanks, Employee #2 stated, “That’s been a problem for months. We mop it up and it comes back. I don’t know where it is coming from. There is no reason to overflow from those tanks.” An interview was conducted on 03/19/24 at 2:22 p.m. with Employee #4 regarding cleaning the acid room. Employee #4 stated, “When we dump the acid into the tank, it is really powdery and flies all over the tank. Sometimes it comes out in clumps and causes a splash. In order to clean it off of everything, it needs to be sprayed down with vinegar, usually at closing. We used to document it, but we no longer do that. There is no specific assignment for it.” Regarding the standing liquid behind the bio carbon tanks, Employee #4 stated, “The water behind the tanks has been a problem for months. We have reported it multiple times to Biomed [Employee #5]. We can’t figure out where it is coming from. [Employee #5] has replaced the pumps and O-rings but can’t figure out where it is coming from. We mop it up and then it reappears.” An interview was conducted on 03/19/24 at 2:40 p.m. with Employee #3 regarding the standing liquid behind the bio carbon tanks. Employee #3 stated, “I don’t think anything is leaking. I think the staff spill water from the tanks and only clean what they see from the front. I think the water flows behind the tanks and builds up over time until they notice it and mop it again.” An interview was conducted on 03/19/24 at 3:05 p.m. with Employee #1 regarding cleaning the acid room. Employee #1 stated, “We do not have an assigned staff scheduled to clean the acid room, but we will, because it needs to be cleaned. I was not aware of the standing water in the room, but it will be looked into for resolution.””