Davita Monroe Township Dialysis

“Dialysis Emergency Equipment CFR(s): §494.62(b)(9) Condition for Coverage: [(b) Policies and procedures. The dialysis facility must develop and implement emergency preparedness policies and procedures, based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, and the communication plan at paragraph (c) of this section. The policies and procedures must be reviewed and updated at least every 2 years. At a minimum, the policies and procedures must address the following:] (9) A process by which the staff can confirm that emergency equipment, including, but not limited to, oxygen, airways, suction, defibrillator or automated external defibrillator, artificial resuscitator, and emergency drugs, are on the premises at all times and immediately available. This Standard is not met as evidenced by: 49828 Based on observation of one of two emergency evacuation boxes, staff interviews, and review of facility documents, it was determined that the facility failed to ensure that medications are kept in a locked storage area when not in use. Findings include: During a tour of the Hemodialysis Treatment Floor on 06/09/25 at 11:20 AM, two emergency evacuation boxes were observed under the Nurse’s Station across from to Station 6. Both boxes were not secured with a lock. One of the two boxes contained supplies for In-Center Hemodialysis (ICHD) which included two unopened vials of heparin (blood thinning medication). During an interview at 11:20 AM with Staff (S)3 (Clinic Coordinator and Charge Nurse), he/she stated that they were never instructed that the evacuation boxes should be locked when not in use. S3 then stated that he/she believed medications should be kept in a locked area. Facility policy titled, “Emergency Equipment Checks” revised October 2024 stated, “Purpose: Verify that emergency equipment is maintained in a ready-to-use condition ... 3. The following equipment checks will be performed by a license nurse teammate to verify the designated equipment is available and functional: ... Break away lock is intact ... 9. The part of the cart containing medications and other supplies will be sealed with a break away lock and is only to be opened in the event of an emergency situation or the replacement of an outdated item. ...” N.J.A.C 8:43A-9.5(a)”

“IC-WEAR GLOVES/HAND HYGIENE CFR(s): 494.30(a)(1) Wear disposable gloves when caring for the patient or touching the patient’s equipment at the dialysis station. Staff must remove gloves and wash hands between each patient or station. This Standard is not met as evidenced by: 48966 Based on one of one observation of Central Venous Catheter (CVC, a type of access used for hemodialysis) exit site cleaning, staff interview, and review of facility documents, it was determined that the facility failed to ensure that hand hygiene is performed during exit site cleaning of a CVC to prevent cross contamination in accordance with facility policy. Findings include: On 06/09/25 at 9:56 AM in Station 4, Staff (S)10 (Registered Nurse [RN]) was observed cleaning the CVC exit site of Patient (P)8. S10 removed the old, existing dressing of the CVC and then removed his/her gloves. S10 donned (put on) a new pair of gloves, without the benefit of performing hand hygiene, and cleaned the CVC exit site in a back and forth motion for 21 seconds with a 2% Chlorhexidine swab. S10 then removed his/her gloves and without the benefit of performing hand hygiene first, donned a new pair of gloves before he/she applied a new dressing onto the exit site. S10 proceeded to remove his/her gloves and without the benefit of performing hand hygiene first, donned a new pair of gloves before he/she removed the old gauze around the CVC limbs. During an interview on 06/09/25 at 10:15 AM, S10 confirmed he/she did not hand sanitize between glove changes. S10 stated, “I should hand sanitize between glove changes.” Facility policy titled, “Infection Control For Dialysis Facilities,” revised April 2023, stated, “ ... Hand Hygiene 1. All teammates, Physicians, and Non-Physician (NPP) will perform hand hygiene ... b. prior to gloving and immediately after removal of gloves, ... “ N.J.A.C. 8:43A-24.8(b)”

“IC-DISINFECT SURFACES/EQUIP/WRITTEN PROTOCOL CFR(s): 494.30(a)(4)(ii) [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-] (ii) Cleaning and disinfection of contaminated surfaces, medical devices, and equipment. This Standard is not met as evidenced by: 51227 Based on two of two observations of the disinfection of hemostats, staff interview, and a review of facility documents, it was determined that the facility failed to ensure that hemostats are disinfected after use in accordance with facility policy. Findings include: On 06/09/25 at 10:44 AM, a 1:100 bleach solution (one part bleach to 100 parts water) container located on the dirty sink counter across from Station 2 was observed to contain four plastic hemostats. One hemostat was in the closed position and another was not fully submerged in the bleach solution. This prevented the bleach solution from making contact with and disinfecting all surfaces of the hemostats. At 10:46 AM, a 1:100 bleach solution container located on the dirty sink counter across from Station 8 was observed to contain six plastic hemostats. Two of the hemostat were in the closed position and one was not fully submerged in the bleach solution. This prevented the bleach solution from making contact with and disinfecting all surfaces of the hemostat clamps. During an interview at 10:50 AM, Staff (S)3 (Clinical Coordinator [CC]), confirmed that the hemostat clamps were in a closed position and that some were not fully submerged in the bleach solution. S3 also stated that the clamps should be in an open position and fully submerged while soaking in the bleach solution. Facility policy titled, “Infection Control for Dialysis Facilities,” revised April 2023, stated, “... Disinfection ... 14. ... b. Hemostats (blood line clamps) should be in the open position and fully submerged in an appropriate disinfectant solution ...” N.J.A.C. 8:43A-24.8(b)”

“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: 48966 Based on two of the two observations of the care of a Central Venous Catheter (CVC, a type of access used for hemodialysis), staff interviews, and review of facility documents, it was determined that the facility failed to ensure that catheter exit site care is performed in accordance with facility policy and procedure. Findings include: On 06/09/25 at 9:56 AM, in Station 4, Staff (S)10 (Registered Nurse [RN]), was observed cleaning the CVC exit site of Patient (P)8. S10 cleaned the catheter exit site in a back and forth motion for 21 seconds with a 2% Chlorhexidine Gluconate prepackaged swab and allowed it to dry for one minute. This was nine seconds less than the 30 second cleanse time required by facility policy and procedure. During an interview at 10:15 AM, S10 stated the exit site should be cleaned with Chlorhexidine for one minute. During an interview at 10:17 AM, S3 (Clinical Coordinator [CC]), stated the exit site should be cleaned for 30 seconds with Chlorhexidine . 51227 On 06/09/25 at 12:35 PM, in Station 10, S10 initiated hemodialysis through a CVC. S10 cleansed the CVC exit site using a 2% Chlorhexidine Gluconate prepackaged swab for 20 seconds, this was 10 seconds less than required by facility policy. S10 then removed the arterial cap and used one alcohol preparation (prep) pad to clean the hub for seven seconds, this is eight seconds less than required per facility policy. With another alcohol prep pad, S10 proceeded to remove the cap from the venous limb and scrubbed the hub for six seconds. This is nine seconds less than required per facility policy. S10 did not clean and disinfect the limbs of the catheter and the arterial and venous cap prior to removal before cleaning the catheter hubs in accordance to facility policy and procedure. During an interview at 12:55 PM, S10 stated that he/she should clean the exit site for 30 seconds and scrub the catheter hub for 15 seconds with alcohol. When asked about cleaning the limbs of the CVC, S10 stated, “I don’t think I have to do that.” A review of S10’s personnel file indicated the “NJ Specific Education Required for New Hire Teammates and Annually For All Teammates” which included Access Care and Management was completed on 09/02/24. Facility Policy titled, “Central Venous Catheter (CVC) With Clearguard HD Antimicrobial End Caps Procedure,” revised April 2025, stated, “... Procedure Holding catheter with non-dominant hand and using aseptic technique, clean exit site with 2 Chlorhexidine Gluconate/70% Isopropyl Alcohol swab for a minimum of 30 seconds, apply to the CVC exit site in a back and forth pattern, using gentle friction progressing from the insertion site to the periphery using both sides of the swab ...” Facility policy titled, “Central Venous Catheter (CVC) With Clearguard HD Antimicrobial End Caps Procedure,” revised April 2025, stated, “... Device Disinfectant and Skin Antiseptic ... 2 % Cholorhexidine Gluconate ... Effective Contact Time ... 30 seconds back and forth motion ... Procedure ... 9. Clean each CVC limb/cap with a new LARGE alcohol prep pad, starting close to the exit site and finishing with the cap ... 16. Verify both catheter clamps are closed. Using aseptic technique remove each cap. One at a time, disinfect each CVC hub with a new alcohol prep pad. Scrub each CVC hub for 15 seconds including the sides, threads, and end of hub thoroughly with friction making sure to remove any residue, for example blood hold the limbs until the antiseptic has dried ...” N.J.A.C. 8:43A-24.8(b)”

“DIALYS PROPORT-MONITOR PH/CONDUCTIVITY CFR(s): 494.40(a) 5.6 Dialysate proportioning: monitor pH/conductivity It is necessary for the operator to follow the manufacturer’s instructions regarding dialysate conductivity and to measure approximate pH with an independent method before starting the treatment of the next patient. This Standard is not met as evidenced by: 51227 Based on two of three observations of machine dialysate pH (potential of Hydrogen) testing, staff interview, and review of facility documents, it was determined that the facility failed to ensure that pH testing is completed in accordance with facility policy. Findings include: On 06/09/25 at 11:45 AM, S9 (Patient Care Technician [PCT]) obtained a sample of the machine dialysate in a syringe from the hemodialysis (HD) machine in Station 6. S9 had an RPC E-Z Check pH test strip in his/her hand and proceeded to allow the fluid to flow over the pad of the strip. S9 then walked to the dirty sink across from Station 8 and looked through the splash guard at the back of the sink to the pH strip bottle located on the ledge on other side of the splash guard and stated, “It’s 7.2.” S9 did not match the strip alongside the color chart on the bottle. At 12:30 PM, S9 obtained a sample of the machine dialysate in a syringe from the HD machine in Station 7. S9 had an RPC E-Z Check pH test strip in his/her hand and proceeded to allow the fluid to flow over the pad of the strip. S9 then walked to the dirty sink across from Station 8 and looked through the splash guard at the back of the sink to the pH strip bottle located on the ledge on other side of the splash guard and stated, “It’s 7.2.” S9 did not match the strip alongside the color chart on the bottle. During an interview at 11:50 AM, S9 stated that he/she could see the color chart from across the countertop and stated the number was 7.2. During an interview at 11:55 AM, S3 (Clinical Coordinator [CC]) was asked how the test strip should be compared to the bottle for a pH reading. S3 stated, “the test strip should be compared next to the pH bottle not from afar.” During an interview on 06/10/25 at 12:05 PM, S8 (biomedical technician) stated, test strips should be matched using a side by side comparison to the bottle for an accurate reading of pH. Facility policy titled, “Testing pH For Acetate Based Dialysate Using RPC E-Z Chek K100-0117 6.8-8.5 Test Strips,” revised February 2024, stated, “... Procedure ... 4. Match the strip as closely as possible to one of the color scales on the bottle and read the pH range listed above the matched color. ...” N.J.A.C. 8:43A-24.4(a)”

“PE-SAFE/FUNCTIONAL/COMFORTABLE ENVIRONMENT CFR(s): 494.60 The dialysis facility must be designed, constructed, equipped, and maintained to provide dialysis patients, staff, and the public a safe, functional, and comfortable treatment environment. This Standard is not met as evidenced by: 48966 Based on observation of the Water Treatment Room, it was determined the facility failed to ensure that a defect free environment is maintained at all times. Findings include: During a tour of the Water Treatment Room conducted on 06/09/25 at 10:39 AM, with Staff (S)7 (covering Bio-Medical Technician), the following was observed: Between the two acid storage tanks, approximately 48 inches of a brown substance was observed on the walls and floor. A white precipitate was present on the two electrical outlets and on the floor. To the left of the “2K (potassium) 2.5 Ca (calcium)” acid tank, an additional 12 inches of a brown substance was observed on the wall. The floors throughout the Water Treatment Room were soiled with brown and black substances across various sections. S7 confirmed the above findings upon discovery. During an interview on 06/09/25 at 11:20 AM, S1 (Facility Administrator [FA] ), stated the Patient Care Technicians (PCTs) are responsible to maintain the cleanliness in the water room, and that S14 (Bio-Medical Technician) will inform S1 if the water room was dirty and would proceed to clean it, when needed. N.J.A.C. 8:43A-17.3(j)”

“PE-BUILDING-CONSTRUCT/MAINTAIN FOR SAFETY CFR(s): 494.60(a) The building in which dialysis services are furnished must be constructed and maintained to ensure the safety of the patients, the staff and the public. This Standard is not met as evidenced by: 51040 Based on observations and staff interview, it was determined that the facility failed to ensure that cabinet surfaces are maintained to ensure the surfaces can be properly cleaned. Findings include: On 06/10/25 at 11:11 AM, during a tour with Staff (S) 8 (covering Bio-Medical Technician), the Home Training Rooms 1, 3, and 4 were observed with the top laminate of the upper cabinets loose, and coming off of the cabinet surface. This exposed an uncleanable surface. This finding was confirmed at the time of discovery by S8. N.J.A.C. 8:43A-17.3(a)”

“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: 51040 Based on observation and staff interview, it was determined that the facility failed to ensure that the Reverse Osmosis (RO) Water Room is properly maintained. Findings include: On 06/10/25 at 11:19 AM, during a tour with Staff (S)8 (covering Bio-Medical Technician), the following was observed in the RO Water Room: The utility sink was leaking from underneath, where the “P” trap met the floor drain, and there was a leak on the tubing fitting where the red tubing met the gray tubing adapter, which caused liquid to leak onto the pump control box and the electrical outlet. This finding was confirmed at the time of discovery by S8. N.J.A.C. 8:43A-17.3(a)”

“POC-VASCULAR ACCESS-MONITOR/REFERRALS CFR(s): 494.90(a)(5) The interdisciplinary team must provide vascular access monitoring and appropriate, timely referrals to achieve and sustain vascular access. The hemodialysis patient must be evaluated for the appropriate vascular access type, taking into consideration co-morbid conditions, other risk factors, and whether the patient is a potential candidate for arteriovenous fistula placement. This Standard is not met as evidenced by: 51227 Based on one of two observations of the initiation of hemodialysis through an arteriovenous fistula (AVF, a type of vascular access used for hemodialysis), staff interview, and a review of facility documents, it was determined that the facility failed to ensure that the staff perform skin disinfection of the access site prior to initiating the dialysis treatment in accordance with facility policy. Findings include: On 06/09/25 at 12:05 PM, in Station 6, Staff (S)9 (Patient Care Technician [PCT]), was observed initiating hemodialysis through an AVF. S9 cleansed both sites of the AVF with one povidone iodine preparation (prep) pad in a circular motion for 20 seconds. This was 10 seconds less than required by facility policy. S9 did not clean the second site with a new povidone iodine prep pad in accordance with facility policy. During an interview at 12:15 PM, S9 stated, he/she should cleanse the AVF site for 30 seconds using one iodine prep pad for each site. When asked if he/she used a second iodine prep pad to cleanse the second site S9 stated, “the patient’s sites are close together, so I used only one.” Facility policy titled, “AV Fistula or Graft Cannulation With Nipro Or Medisystems Safety Fistula Needles (SFN) and Administration of Heparin Loading Dose,” revised April 2025, stated, “ ... Skin Antiseptic ... Povidone Iodine ... Effective Volume ... At least 1 prep pad per site or 1 saturated sterile gauze pad per site ... Effective Contact Time ... 30 seconds ... Procedure: ...11. While maintaining aseptic technique, cleanse the site by applying skin antiseptic using a circular rubbing motion, moving from the center out and allow to dry. (For contact and dry time refer to table above) ... “ N.J.A.C. 8:43A-24.8(b)”