Davita Middletown Dialysis Center

“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: 50912 Based on two of five staff members observed for hand hygiene, staff interview, and review of facility policy, it was determined that the facility failed to ensure that hand hygiene is performed to prevent cross contamination in accordance with facility policy. Findings include: On 11/19/25 at 10:50 AM, in Station 3, Staff (S)8, while wearing gloves, was observed cleaning and disinfecting the hemodialysis machine by wiping it with a bleached soaked cloth. At this time, an audible alarm was alerting in patient occupied Station 1. After S8 removed his/her gloves, he/she exited Station 3 and entered Station 1. S8 put on new gloves and talked with the patient. S8 then typed on the hemodialysis machine’s keyboard to silence the alarm. S8 did not perform hand hygiene when he/she exited Station 3 or before he/she entered Station 1. S8 then returned to Station 3, performed hand hygiene, put on new gloves and resumed cleaning the hemodialysis machine. At 11:00 AM, S8, with gloved hands, was observed cleaning the dialysis machine in Station 3, with bleached soaked cloth. After taking off his/her gloves, S8 then exited the station and entered the patient occupied Station 9. S8 put on new gloves and proceeded to reinforce and change the dressing on the patient’s right Arteriovenous Graft/Fistula (AVG/F, a type of hemodialysis access). S8 did not perform hand hygiene when he/she exited Station 3 or before he/she entered Station 9. At 11:06 AM, after cleaning and disinfecting Station 3, S8 removed his/her gloves, exited the station, and entered the patient occupied Station 4. S8 then put on new gloves, spoke to and assisted the patient from the treatment floor. S8 did not perform hand hygiene when he/she exited Station 3 and prior to entering Station 4. During an interview at 11:18 AM, S8 stated he/she should have performed hand hygiene with sanitizer between clean glove changes and prior to entering another occupied patient station. A review of S8’s education file revealed that he/she successfully completed the “New Jersey Specific Education Attestation” on 3/14/25 and the “Annual Procedural Skills Verification Checklist” on 7/3/25 which included topics on Hand Hygiene. 37656 On 11/19/25 at 10:45 AM, a patient completed hemodialysis treatment and left Station 12. S6, with gloves on, was observed typing on the chairside computer’s keyboard. S6, with the same gloves on, moved to Station 13’s chairside computer where another patient was dialyzing. S6 did not remove gloves and did not perform hand hygiene after leaving Station 12. During an interview at 10:50 AM, S6 stated that he/she should have removed his/her gloves and performed hand hygiene prior to leaving the dialysis station. A review of S6’s annual education file revealed that he/she successfully completed the “Annual Procedural Skills Checklist” on 02/24/25, which included policies and procedures on infection control and Hand Hygiene. 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 a. upon entering and exiting the patient treatment area, b. prior to gloving and immediately after removal of gloves, c. after contamination with blood or other infectious material, d. after patient and dialysis delivery system contact. ... f. between patients even if contact is casual, g. before touching clean areas such as supplies, supply cart and chairside keyboard/mouse. ...” 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: 50912 Based on two of two observations of the cleaning and disinfection of hemodialysis stations, staff interview, and a review of facility documents, it was determined that the facility failed to ensure that all equipment and surfaces are cleaned and disinfected after each patient use. Findings include: On 11/19/25 at 10:30 AM in Station 12, the patient completed hemodialysis treatment and was disconnected from the hemodialysis machine. Staff (S)6 and S9 utilized a Hoyer lift (a mechanical device used to lift patients) to transfer the patient from the dialysis chair into a wheelchair. S6 removed the Hoyer lift from the station and placed it into a hallway next to the wall, located across from Station 12. To the right of the Hoyer lift was an emergency evacuation box and a clean utility cart containing dialysis supplies on the left side. S6 did not clean and disinfect the Hoyer lift after patient use or before he/she returned it to the hallway. During an interview at 10:50 AM, S6 stated, “Oh I should have cleaned it right away, I will clean and disinfect the Hoyer lift as soon as possible.” 37656 On 11/19/25 at 10:53 AM, S6 was observed during the cleaning and disinfecting of Station 13. S6, after removing the bloodlines from the machine, put on a clean set of gloves and removed the prime bucket from the uncleaned dialysis machine before he/she emptied the liquid into the dirty sink. S6 then cleaned the prime bucket with cloth saturated with 1:100 bleach solution (one part bleach to 100 parts water), and placed it back on the side of the unclean machine. This caused potential cross contamination onto the clean prime bucket. S6 then proceeded to clean the dialysis machine, the surfaces around the prime bucket, and the rest of the station. S6 did not clean the stethoscope and the blue bag (containing blue clamps) that were hanging on the pole and the blue arm rest on the chase wall. S6 did not clean the prime bucket again. During an interview at 11:00 AM, S6 stated that the blue arm rest was not used by the patient and did not know why it was there. S6 cleaned the blue arm rest, the stethoscope and the blue bag after interview and when asked about the prime bucket, he/she re-cleaned the prime bucket with 1:100 bleach wipes. A review of S6’s training file indicated that S6 received “Certificate of Completion on Infection Control for Dialysis Facilities,” dated 3/15/25, which included education regarding cleaning and disinfection procedures of dialysis equipment and environmental surfaces. Facility policy titled, “Infection Control for Dialysis Facilities,” revision date April 2023, stated, “... Disinfection 12. Cleaning and/or disinfection of equipment and work surfaces will be performed as soon as possible ... and prior to returning to clean/designated area or removal from treatment area. 13. At the end of each treatment, the dialysis station will be cleaned and disinfected. a. Surfaces to disinfect include but are not necessarily limited to: all surfaces in contact with the patient or their belongings (e.g., dialysis chair, tray tables, blood pressure duffs) and frequently contacted by healthcare personnel (e.g., control panel; top, front and sides of dialysis machine; touchscreens; countertops) ...” N.J.A.C. 8:43A-24.8(b)”

“POC-ACHIEVE ADEQUATE CLEARANCE CFR(s): 494.90(a)(1) Achieve and sustain the prescribed dose of dialysis to meet a hemodialysis Kt/V of at least 1.2 and a peritoneal dialysis weekly Kt/V of at least 1.7 or meet an alternative equivalent professionally-accepted clinical practice standard for adequacy of dialysis. This Standard is not met as evidenced by: 50912 Based on medical record review, staff interview, and review of facility documents, it was determined that the facility failed to ensure that patients receive the prescribed BFR (blood flow rate, the speed at which blood is pumped through the dialyzer during hemodialysis) as ordered by the physician for three of nine hemodialysis treatment sheets. Findings include: A review of Patient (P)6’s Plan of Care, dated 11/06/25, stated, “... Adequacy, Maintain adequacy goal. ...” A review of P6’s Treatment Details Report from 10/15/25 to 11/17/25 revealed the prescribed BFR for this patient was 400 milliliters per minute (400 mL/min). Further review revealed the following: On 10/24/25, hemodialysis treatment was initiated at 6:45 AM with a BFR at 350 mL/min until 8:39 AM. The BFR was changed to 300 mL/min at 9:09 AM for the remainder of the treatment until 9:55 AM. There was no documentation in the medical record of a reason for the low BFR, that the Patient Care Technician (PCT) notified the Registered Nurse (RN) of the change in BFR, or that the RN notified the physician that the BFR was set lower than the prescribed rate. On 10/27/25, hemodialysis treatment was initiated at 6:23 AM with a BFR at 360 mL/min. At 6:48 AM, the BFR was changed to 340 mL/min until 8:48 AM. At 9:18 AM, the BFR was changed to 320 mL/min for the remainder of the treatment until 9:48 AM. There was no documentation in the medical record of a reason for the low BFR, that the PCT notified the RN of the change in BFR, or that the RN notified the physician that the BFR was set lower than the prescribed rate. On 11/14/25, hemodialysis treatment was initiated at 6:32 AM with a BFR at 400 mL/min. At 6:57 AM, the BFR was changed to 350 mL/min until 8:29 AM. At 8:57 AM the BFR was changed to 300 mL/min for the remainder of the treatment until 10:04 AM. There was no documentation in the medical record of a reason for the low BFR, that the Licensed Practical Nurse (LPN) notified the RN of the change in BFR, or that the RN notified the physician that the BFR was set lower than the prescribed rate. On 11/20/25 at 1:02 PM, above findings were reviewed and confirmed with Staff (S)10. Upon interview at 1:06 PM, S10 stated that there should be documentation by the PCT explaining why the BFR was set at a rate lower than prescribed by the Nephrologist. S10 stated that the PCT should have notified the RN why the BFR was set at a lower rate and documented that the RN was notified. S10 stated that the RN should then assess the patient, document the findings, make the physician aware, and obtain an order to run the BFR at a lower rate. Facility policy titled, “Pre-Intra-Post Treatment Data Collection, Monitoring and Nursing Assessment,” revised April 2024, stated, “... Intradialytic Data Collection/Assessment ... 10. If the dialysis prescription is not being met (including dialysis flow rate or change to/inability to obtain prescribed blood flow rate) the reason will be documented and the licensed nurse informed ... 11. Abnormal findings or findings outside of any patient specific physician ordered parameters will be reported to the licensed nurse immediately. ...” N.J.A.C. 8:43A-24.4(a)”

“POC-PTS SEEN BY MED STAFF 1X/MO CFR(s): 494.90(b)(4) The dialysis facility must ensure that all dialysis patients are seen by a physician, nurse practitioner, clinical nurse specialist or physician’s assistant providing ESRD care at least monthly, as evidenced by a monthly progress note placed in the medical record, and periodically while the hemodialysis patient is receiving in-facility dialysis. This Standard is not met as evidenced by: 39223 Based on medical record review (Patient (P)8) and review of facility documents, it was determined that the facility failed to ensure that monthly provider notes are documented for one of six months reviewed. Findings include: A review of P8’s medical record did not reveal monthly provider notes for September of 2025. This was reviewed with Staff (S)10 on 11/20/25 at 1:10 PM who confirmed that the monthly notes were not in the medical record. Facility policy titled, “Progress Note Policy,” originated September 2007, stated, “... 7. ... Physician: The attending Nephrologist is required to record progress notes at least monthly and for any clinical event, which must be recorded in a timeframe that provides other interdisciplinary team members with an up-to-date picture of the status of the patient at all times. ...” N.J.A.C. 8:43A-24.13(d)”

“MD RESP-ENSURE ALL ADHERE TO P&P CFR(s): 494.150(c)(2)(i) The medical director must- (2) Ensure that- (i) All policies and procedures relative to patient admissions, patient care, infection control, and safety are adhered to by all individuals who treat patients in the facility, including attending physicians and nonphysician providers; This Standard is not met as evidenced by: 37656 Based on a review of two of two medical records (Patient [P]5 and P7), staff interviews, and a review of facility documents, it was determined that the Medical Director failed to ensure that the Registered Nurse (RN) verifies the patient’s dialysis prescription within one hour of initiation of treatment in accordance with facility policy and procedure. Findings include: A review of P5’s hemodialysis treatment flow sheets revealed the following: On 11/04/25, P5’s dialysis prescription was verified by a Patient Care Technician (PCT) at 10:01 AM and hemodialysis was started at 11:30 AM. The prescription was verified by a registered nurse (RN) at 1:02 PM, one hour and 30 minutes after dialysis was started. On 11/06/25, P5’s dialysis prescription was verified by a PCT at 10:02 AM and hemodialysis was started at 10:20 AM. The prescription was verified by a RN at 12:57 PM, two hours and 37 minutes after dialysis was started. On 11/08/25, P5’s dialysis prescription was verified by a PCT at 9:52 AM and hemodialysis was started at 11:00 AM. The prescription was verified by a RN at 12:18 PM, one hour and 18 minutes after dialysis was started. A review of P7’s hemodialysis treatment flow sheets revealed the following: On 10/29/25, P7’s dialysis prescription was verified by a PCT at 5:21 AM and hemodialysis was started at 5:41 AM. The prescription was verified by a RN at 7:17 AM, one hour and 36 minutes after dialysis was started. On 10/31/25, P7’s dialysis prescription was verified by a PCT at 5:02 AM and hemodialysis was started at 5:47 AM. The prescription was verified by a RN at 7:17 AM, one hour and 30 minutes after dialysis was started. On 11/12/25, P7’s dialysis prescription was verified by a PCT at 5:09 AM and hemodialysis was started at 5:28 AM. The prescription was verified by a RN at 7:35 AM, one hour and 51 minutes after dialysis was started. On 11/17/25, P7’s dialysis prescription was verified by a PCT at 5:08 AM and hemodialysis was started at 5:47 AM. The prescription was verified by a RN at 7:06 AM, one hour and 19 minutes after dialysis was started. On 11/20/25 at 2:38 PM, the above flow sheets were reviewed with Staff (S)1 who confirmed that the RN should review the dialysis prescription within one hour of treatment in accordance with policy. Facility policy titled, “PRE-INTRA-POST TREATMENT DATA COLLECTION, MONITORING AND NURSING ASSESSMENT,” stated, “... 3. Patient identity, prescription and machine settings are verified by teammate prior to initiation of treatment with the exception of blood flow rate ... . The prescription components are confirmed by a licensed nurse within one (1) hour of treatment initiation along with the nursing assessment or as allowable by state law. N.J.A.C. 8:43A-24.4(a)”