Fresenius Medical Care Camden

“IC-SANITARY ENVIRONMENT CFR(s): 494.30 The dialysis facility must provide and monitor a sanitary environment to minimize the transmission of infectious agents within and between the unit and any adjacent hospital or other public areas. This Standard is not met as evidenced by: 22313 Based on observations, record reviews, and interview, the facility failed to ensure its staff followed accepted principles of infection control in the renal setting for patients performing hand hygiene when arriving and exiting the dialysis treatment room. (3 random patients). Random observations showed staff failed to clean stethoscopes between dialysis stations and one of Patient Care Technician (PCT #5) retrieved trash from the dialysis treatment room floof without removing the soiled glove and performing hand hygience. (PCT #5) The findings include: Upon the initial tour on 1/2/2024 at 9:30 AM, random observations in the dialysis treatment rooms revealed 3 random patients did not perform hand hygiene when arriving and prior to exiting the dialysis treatment room after holding their access sites post dialysis. In an interview on 1/4/2024 at 12:00 PM, the Facility Manager and Charge Nurse reported “The people get so busy”. Facility policy, entitled, “Hand Hygiene”, reads, “Decontaminated using Alcohol based hand rub or by washing hands with antimicrobial soap and water 1) Before and after direct contact with patients 2) Entering and leaving the treatment area 3) before performing any invasive procedure such as vascular access cannulation or administration of medications 4) immediately after removing gloves 5) After contact with body fluids ...or non-intact skin or wound dressings 6) After contact with inanimate objects near the patients (stethoscopes). Patients should perform hand hygiene if able prior to and after each dialysis treatment”. Concerning the hair, Employee Dress Code reads: “To ensure employees maintain a work environment that adheres to safety and infection control the following applies: “Hair must be securely dept away from the face so as not to create an infection control and/or safety risk”. 41743 Observations on 01/03/2024 between 9:12 AM and 11:29 AM revealed Patient Care Technicians (PCT) #5 picked trash off the dialysis treatment room floor with gloved hands at 10:37 AM. Then PCT #5 failed to remove the glove and perform hand hygiene prior to touching the dialysis machine computer screen. Observations showed Registered Nurse (RN) #2 and #3, Patient Care Technicians (PCT) #1 and #2 wearing stethoscopes around their necks and failing to sanitize the stethoscope bell between patients. On 01/04/2024 at 11:00 AM, the Charge Nurse reported “Should be cleaning”. Facility policy, entitled, “Cleaning and disinfecting the Dialysis Station”, revealed, “After use, any non-disposable equipment and supplies brought into the dialysis station (ex. Stethoscope) must be disinfected with 1:100 bleach or EPA registered disinfectant before being removed from the dialysis station” and “The electronic charting device incorporated in the 2008 T dialysis machine is not considered a clean area. Gloves will be required when touching either the screen or keyboard”.”

“IC-TRANSDUCER PROTECTORS-NOT WETTED/CHANGED CFR(s): 494.30(a)(1)(i) Use external venous and arterial pressure transducer filters/protectors for each patient treatment to prevent blood contamination of the dialysis machines’ pressure monitors. If the external transducer protector becomes wet, replace immediately and inspect the protector. If fluid is visible on the side of the transducer protector that faces the machine, have qualified personnel open the machine after the treatment is completed and check for contamination. This includes inspection for possible blood contamination of the internal pressure tubing set and pressure sensing port. If contamination has occurred, the machine must be taken out of service and disinfected using either 1:100 dilution of bleach (300-600 mg/L free chlorine) or a commercially available, EPA-registered tuberculocidal germicide before reuse. Change filters/protectors between each patient treatment, and do not reuse them. Internal transducer filters do not need to be changed routinely between patients. This Standard is not met as evidenced by: 41743 Based on observations, interviews, and facility policy, entitled, “Maintenance of Transducer Protector Procedure”, the dialysis staff failed to change a wet external transducer protector in a timely manner and failed to follow the facility’s policy and procedure for potential dialysis machine contamination. Registered Nurse (RN) #3 and Patient Care Technician (PCT) #1 and #3). The finding includes: Observations on 01/03/2024 between 10:25 AM and 10:58 AM revealed red fluid on the front of the external transducer protector for dialysis station #19. RN #3 observed at the computer at 10:26 AM, but failed to change the wet external transducer protector. PCT #3 was observed at the computer at 10:40 AM, but failed to change the wet external transducer protector. End of treatment at 10:58 AM, PCT #1 removed tubing but failed to observe the external wet transducer protector. When PCT #1 was requested to check the back of the wet external transducer protector and explain the facility’s procedure for checking for potential contamination, PCT #1 reported, “If wet, machine should be not used by another patient till checked.” Observations showed the back of the wet external transducer protector had no wetness or fluid breakthrough. PCT #1 observed later removing the dialysis machine from the dialysis treatment room. Facility policy, entitled, “Maintenance of Transducer Protector Procedure” reveals, “External transducer protectors must be changed immediately when they become wet with blood or other fluid. Wet external transducer protectors must be thoroughly examined to determine if any blood or other fluid contamination is visible on the machine side (back) of the transducer protector prior to replacement. If no evidence of blood or fluid contamination is evident, no further action is required other than replacing the wet transducer.”.”

“IC-ASEPTIC TECHNIQUES FOR IV MEDS CFR(s): 494.30(b)(2) [The facility must-] (2) Ensure that clinical staff demonstrate compliance with current aseptic techniques when dispensing and administering intravenous medications from vials and ampules; and This Standard is not met as evidenced by: 41743 Based on observations, interviews, and review of the facility’s policy, entitled, “Medication Preparation and Administration”, two of two dialysis Registered Nurses (RN) failed to sanitize intravenous ports or multidose vial septums prior to administering medications or needle insertions. (RN # 2 and RN #3). The findings include: Observations on 01/03/2024 at 10:22 AM revealed RN #3 administering medication via intravenous catheter port without first sanitizing the intravenous port with alcohol. Observations on 01/04/2024 at 10:05 AM revealed RN #2 removed medication from a multi-dose vial without sanitizing vial’s septum with alcohol for 3 needle insertions. On 01/04/2024 at 11:00 AM with the Charge Nurse revealed “part of policy”. Dialysis policy, entitled, “Medication Preparation and Administration”, revealed, “Infection Control. Disinfect IV ports prior to accessing, using friction and 70% alcohol, iodophor or chlorhexidine/alcohol agent. Cleanse the diaphragm with a new alcohol wipe each time an IV port is accessed. Cleanse the diaphragm of a vial with alcohol prior to accessing the vial. If the vial is a multidose vial, cleanse the diaphragm with a new alcohol pad each time the vial is accessed with a needle using friction and 70% (percent) alcohol.”

“PA-ASSESS B/P, FLUID MANAGEMENT NEEDS CFR(s): 494.80(a)(2) The patient’s comprehensive assessment must include, but is not limited to, the following: Blood pressure, and fluid management needs. This Standard is not met as evidenced by: 41743 Based on record review, interview, and review of the facility’s policy, entitled, “Intradialytic Hypotension”, the facility staff failed to monitor Blood Pressure (BP) and patient status every 30 minutes for 2 of 7 patient charts. (Patient #2 and #3) The finding includes: On 01/03/2024 at 2:10 PM, chart review for Patient #2 revealed documentation for 12/14/2023 dialysis treatment for vital signs at 2:58 PM: BP 153/61 and at 3:56 PM: BP 144/59. This was 58 minutes between patient assessments. On 01/04/2024 at 11:07 AM, the Charge Nurse verified the finding. On 01/03/2024 at 2:40 PM, chart review for Patient #3 revealed documentation for vital signs on 12/12/2023 dialysis treatment at 11:04 AM: BP 160/80 and at 1:04 PM: BP 143/73. This was 2 hours between patient assessments. the dialysis treatment on 12/16/2023 revealed vital signs at 11:30 AM: BP 123/69 and at 1:30 PM: BP 96/59. This was 60 minutes between patient assessments. Dialysis treatment on 12/23/2023 revealed vital signs at 12:43 PM: BP 100/40 and at 1:38 PM: BP 123/59. This was 55 minutes between patient assessments. On 1/03/2024 at 11:14 AM , the Charge Nurse verified the findings. Dialysis policy, entitled, “Intradialytic Hypotension”, revealed, “Prevention of Intradialytic Hypotension Monitor BP at least every 30 minutes during treatment-recheck potentially aberrant readings”.”