Ara - Milwaukee

“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: 28297 Based on observation, interview, and policy review, the facility failed to ensure the transducer protector was changed immediately after being wetted for one of three survey days. The failure to change the transducer protector immediately had potential for contamination of the internal transducer and this could impact 65 in-center patients. Findings include: Observation of Patient (P)6 at Station 1 on 10/02/24 at 12:37 PM revealed the venous transducer protector contained pale red fluid. Observation of P6 at Station 1 on 10/02/24 at 1:15 PM revealed the venous transducer protector still contained pale red fluid. During an interview on 10/02/24 at 1:15 PM, Patient Care Technician (PCT) 6 confirmed there was fluid up to the venous transducer protector. PCT6 stated he/she did not need to change the transducer protector unless the machine was alarming that indicated a problem with the venous transducer. During an interview on 10/04/24 at 12:15 PM the Charge Nurse stated that if the transducer protector was wet it should have been changed immediately to ensure the machine and pressures were reading correctly. Review of the facility’s policy “Changing Wet Transducer Protectors,” effective 06/12/24 revealed the following: “ ...Remove the wet transducer protector from the machine and check the back of the transducer protector for any signs of blood ...””

“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: 28297 Based on observation, interview, and policy review, the facility failed to ensure expired medications were disposed of appropriately. Failure to remove expired medical supplies had the potential to affect 65 in-center patients receiving dialysis treatments at the facility. In addition, the facility failed to ensure multi-dose vials opened were dated and labeled as required for one of three survey days. The failure to label vials upon opening had the potential for staff to use expired medications and this could affect 65 in-center patients. Findings include: During an observation of the medication refrigerator on 10/04/24 at 9:00 AM, one vial of Purified Protein Derivative (PPD) testing solution (used to test patients for Tuberculosis, a highly contagious respiratory disease) was opened and dated 08/27/24, nine days past the expiration date. During an interview on 10/04/24 at 9:00 AM, Licensed Practical Nurse (LPN) 2 confirmed the medication was expired. LPN 2 stated there were no monthly audits on vaccinations and they were only checked when they were used. Observation on 10/04/24 at 9:10 AM revealed in the heparin preparation area, a multidose vial of Heparin 30,000 units per 30 milliliters was opened and undated. During an interview on 10/04/24 at 9:10 AM, LPN 2 confirmed the vial of open heparin was undated as to when opened. He/she confirmed staff were required to date and label all medications upon opening to ensure they were not expired. During an interview on 10/04/24 at 12:15 PM, the Charge Nurse stated the PPD testing solution should have been removed since it was expired past 30 days and that there needed to be a better process to capture expired vaccinations. The Charge Nurse also stated that staff were expected to date and label all multidose medications upon opening to ensure they were not expired. Review of the facility policy “Medications: Handling, Administration, Storage and Disposal,” revised 06/2023, revealed the following: “ ...Multi-dose medication vials can be used up to 28 days after initial entry, as long as the vial is handled aseptically ...After 28 days the vial and any remaining medication in the vial must be discarded. Multi-dose medication vials shall be labeled with the date the vial was first entered and the initials of the person who first entered the vial ...””

“IC-STAFF EDUCATION-CATHETERS/CATHETER CARE CFR(s): 494.30(a)(2) Recommendations for Placement of Intravascular Catheters in Adults and Children I. Health care worker education and training A. Educate health-care workers regarding the ... appropriate infection control measures to prevent intravascular catheter-related infections. B. Assess knowledge of and adherence to guidelines periodically for all persons who manage intravascular catheters. II. Surveillance A. Monitor the catheter sites visually of individual patients. If patients have tenderness at the insertion site, fever without obvious source, or other manifestations suggesting local or BSI [blood stream infection], the dressing should be removed to allow thorough examination of the site. Central Venous Catheters, Including PICCs, Hemodialysis, and Pulmonary Artery Catheters in Adult and Pediatric Patients. VI. Catheter and catheter-site care B. Antibiotic lock solutions: Do not routinely use antibiotic lock solutions to prevent CRBSI [catheter related blood stream infections]. This Standard is not met as evidenced by: 28297 Based on observation, interview and policy review, the facility failed to ensure the patients’ mask was covering his/her nose during the discontinuation of dialysis via a Central Venous Catheter (CVC) (A hemodialysis central venous catheter is a type of access used for hemodialysis. CVCs are placed under the skin and into a large central vein, preferably the internal jugular veins. CVCs are meant to be used for a short period of time until a more permanent type of dialysis access has been established) for one of three observations. The failure to ensure the mask covered the nose had the potential for contamination of the CVC and increased the risk of infections. This deficient practice could affect 11 of 65 in-patients that have CVCs in the facility. Findings include: Observation on 10/04/24 at 8:55 AM Patient Care Technician (PCT) 9 was at Station 5 discontinuing the treatment for Patient (P) 1 via a CVC. PCT9 completed CVC discontinuation, however P1’s mask remained below his/her nose during the entire discontinuation process. During an interview on 10/04/24 at 8:55 AM PCT9 confirmed P1’s mask was not covering the nose but should have been to prevent cross contamination. During an interview on 10/04/24 at 12:15 PM the Charge Nurse confirmed it was part of the facility policy for staff and patients to wear a mask covering the mouth and nose during CVC discontinuation of dialysis via a CVC to prevent contamination of the CVC. Review of the facility’s policy titled, “CVC-Initiation and Discontinuation of Treatment (TEGO),” revised 04/2023 indicated the following: “ ...At the end of the treatment, wash hands and don PPE [Personal Protective Equipment]. Mask self, patient and anyone assisting or observing ...””

“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: 28297 Based on observations, interview, and facility’s policy, the facility failed to follow the facility’s policy for dialysis (an artificial means of kidney function that removes the waste and excess fluid from the blood by passing it through a filter) treatments by not maintaining the arterial drip chambers (a pressure and air monitoring component of the dialysis bloodline tubing) fluid levels at 85-95% full for one of three survey days. Failure to follow the facility policy had the potential to result in equipment malfunction and/or failure and negatively impact the safety and wellbeing of the 65 in-center patients receiving dialysis treatments in this facility. Findings include: 1. Observation of the hemodialysis treatment area on 10/03/24 at 9:45 AM revealed the arterial drip chamber level was less than 25% full at Stations 10, 11 and 19. 2. Observation on 10/03/24 at 10:15 AM revealed the arterial drip chamber level was less than 25 % full at Station 10 and 11. During an interview on 10/03/24 at 10:15 AM the Charge Nurse confirmed the arterial drip chambers were less than 25 % full at Stations 10 and 11 and should be 75 % full to ensure no air get into the extracorporeal system. 3. On 10/03/24 at 10:20 AM the arterial drip chamber level was less than 25% at Station 19. During an interview on 10/03/24 at 10:20 AM Patient Care Technician (PCT) 6 confirmed he/she was responsible for Station 19. PCT 6 confirmed the arterial drip chamber was less than 25 % full at Station 19 and should have been 75% full to ensure no air gets into the extracorporeal system. Review of the facility’s policy titled, “IC30 Bloodline Setup with Dry Pack Dialyzer” effective 06/12/2024 indicated the following: “ ...Open the clamp on the arterial drip chamber access port. Open the end cap to fill the arterial chamber to the suggested fill level ...Blood chamber fill volume: Combisets:65% to 75%...””

“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: 18750 Based on interview, record review, and policy review, the facility failed to ensure four of seven sampled patients (Patient (P) 2, P4, P5, and P6) were monitored every 30 minutes as required. The failure to monitor patients every 30 minutes had the potential not to capture a potential adverse event in a timely manner and could affect all 65 in-center hemodialysis patients. Findings include: 1. Review of P2’s “medical record” revealed admission date of 02/26/07 with a diagnosis of End Stage Renal Disease (ESRD). Review of P2’s six “dialysis flow records” provided by the facility from 09/16/24-09/27/24 revealed on 09/16/24, P2’s blood pressure was checked at 7:49 AM with a reading of 124/40 and was not checked again until 8:48 AM, with a reading of 40/25, 59 minutes later. Continued review of the “flow record” for 09/20/24 revealed the blood pressure was checked at 8:46 AM with a reading of 87/48 and not again until 9:31 AM with a reading of 86/24, 45 minutes later. Further review revealed on 09/23/24, P2’s blood pressure reading was 111/88 at 6:47 AM and not checked again until 7:34 AM with a reading of 150/23, 47 minutes later. On 09/25/24, P2’s blood pressure was checked at 5:42 AM with a reading was 142/81 and not again until 6:56 AM, reading 120/56, 1 hour 14 minutes later. Continued review of the flow records for 09/27/24 revealed the blood pressure was checked at 6:05 AM with a reading of 116/45 and not again until 7:16 AM with a reading of 130/83, 1 hour 11 minutes later. The next check was at 8:08 AM, with a blood pressure reading of 108/47, 52 minutes later. After 58 minutes, the blood pressure reading was 100/50 at 10:06 AM. 2. Review of P4’s “medical record” revealed admission date of 08/22/24 with diagnoses of ESRD, diabetes mellitus, and congestive heart failure. Review of P4’s six “dialysis flow records” provided by the facility from 09/17/24-09/28/24 revealed on 09/24/24 the patients’ blood pressure was checked at 11:43 AM with a reading of 146/56 and was not checked until 12:43 PM, with a reading of 121/54, 60 minutes later. Continued review of the flow records for 09/28/24 revealed the blood pressure was checked at 10:37 AM with a reading of 127/103 and not again until 11:37 AM with a reading of 146/68, 60 minutes later. 3. Review of P5’s “medical record” revealed admission date of 04/19/17 with diagnoses including ESRD, diabetes mellitus, and congestive heart failure. Review of P5’s six “dialysis flow records” provided by the facility from 09/17/24-09/28/24 revealed on 09/28/24 the patients’ blood pressure was checked at 9:59 AM with a reading of 231/63 and was not checked until 10:49 AM, with a reading of 216/108, 50 minutes later. 4. Review of P6’s “medical record” revealed admission date of 08/22/24 with diagnoses including ESRD, diabetes mellitus, and congestive heart failure. Review of P6’s six “dialysis flow records” provided by the facility for P6 from 09/16/24-09/27/24 revealed on 09/16/24 the patients’ blood pressure was checked at 10:50 AM with a reading of 143/82 and was not checked until 11:50 AM, with a reading of 153/88, 60 minutes later. During an interview on 10/04/24 at 12:15 PM, the Charge Nurse (CN) confirmed that P2 had missing blood pressure and monitoring checks and stated that P2 has poor vascular system and should be monitored often. The CN confirmed that P4, P5 and P6 had missing blood pressure checks and monitoring. CN stated it was the expectation to monitor the patients at least every 30 minutes to ensure they are safe and stable. During an interview on 10/04/24 at 12:39 PM, Patient Care Technician (PCT)6 confirmed checks should occur every 30 minutes unless there are issues with the blood pressure in which the checks should occur more often. Review of the facility’s policy titled, “Monitoring & Documentation of Patient Care During Treatment,” revised 11/29/22 indicated the following: “Purpose: To ensure: that patients are monitored to ensure safety during the hemodialysis treatment ...Policy. . . 10. Data that must be documented (by direct entry and/or by data feed from the dialysis machine) at least every 30 minutes and PRN [as needed] depending on the patient’s condition. . .””