Davita Vineland

“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: 48966 Based on observations, staff interviews, and a review of facility policy, it was determined that the facility failed to ensure that the wall box is cleaned and disinfected in one of two observations of the cleaning and disinfection of the patient stations. Findings include: On 1/7/25 at 10:47 AM, Staff (S) 13, a Registered Nurse (RN), was observed in Station 14 cleaning and disinfecting the machine and chair with bleach-soaked cloths. S13 wiped down the chase wall but did not wipe down the wall box behind the station with a bleach-soaked cloth. During an interview at 10:59 AM, S13 stated wall boxes are to be clean only if visible blood is present and at the end of the day. Facility policy titled, “Infection Control For Dialysis Facilities” revised October 2022, stated, “... Wall Box and Drain/Water Line Care And Maintenance 59. The Wall box, Drain and Water supply lines are considered part of the dialysis delivery system and should be cleaned with 1:100 (one to one hundred) bleach as part of routine station disinfection between each patient treatment ...” 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: 48966 Based one of one observation 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 and manufacturer instructions for use (MIFU) for the RPC E-Z Chek 6.8-8.5 pH test strips. Findings include: On 1/7/25 at 10:13 AM, Staff (S) 11, a Patient Care Technician (PCT), obtained a sample of the machine dialysate in a disposable cup from the machine in Station 7. S11 removed a RPC E-Z Check pH test strip out of the bottle and proceeded to dip the pH test strip in the sample for ten seconds. S11 removed the strip and waited 30 seconds to compare the test strip to the color chart on the bottle. During an interview at 10:15 AM, S11 stated that the pH test strip is dipped for ten seconds and then compared to the color chart on the bottle after 30 seconds. A review of the RPC E-Z Chek 6.8-8.5 Ph Total Chlorine Test Strips instructions for use stated, “... Directions for Bicarbonate/Acetate Dialysate or Bicarbonate Concentrate: ... 2) Dip the strip into fresh solution to be tested. 3) Start the timer as the strip is being pulled from the solution ... 4) Remove the strip and shake off excess liquid. After 10 seconds, compare the strip to the color chart on the bottle ...” Facility policy titled, “Testing pH For Acetate Based Dialysate Using RPC E-Z Check K100-0117 6.8-8.5 Test Strips,” revised February 2024, stated, “... Procedure ... 2. Obtain dialysate sample using a disposable collection cup, then dip the strip into the solution for one (1) second ... 3. Remove the strip from the fluid and shake off excess dialysate. Within 5-10 seconds, compare the strip to the color chart on the bottle. 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. 5. pH test results should be between 6.9-7.6. ...” N.J.A.C. 8:43A-24.4(a)”

“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 observation and staff interview on 1/7/25, it was determined that the facility failed to ensure the dialysis facility is maintained to ensure the safety of the patients and the public. Findings include: During a tour of the facility, beginning at 9:53 AM, with Staff (S) 5, the Biomedical Technician, the following was observed: At 9:53 AM, the ceiling tile near Station 11 was stained and damaged, which could not be cleaned. At 9:55 AM, there was sheetrock cracked above the Isolation Station door. At 10:25 AM, the Water Treatment Room ventilation grill was dirty and packed with airborne debris that would not provide the proper air flow from the room. At 10:45 AM, all floor drains (three of three) in the Treatment Room were blocked with dirt and debris which would not allow water to properly drain from the floor. At 10:48 AM, the ceiling area between Stations 13 and Station 14, in front of the HVAC (heating, ventilation and air-conditioning) vent was cracked and peeling and in need of repair. At 11:15 AM, there was lower area wall surface damage next to clean sink #10 that could not be properly cleaned. At 11:32 AM, the wall surface was damaged to the right of the rear entrance to the treatment room, which could not be properly cleaned. At 11:33 AM, a deadbolt lock was found in the open position on the fire separation doors near the Soiled Utility Room. Positive locking devices are not permitted on smoke/fire separation doors. S5 confirmed the above findings at 11:35 AM 1/7/25. N.J.A.C. 8:43A-17.3(j)”

“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: 39223 Based on observation, staff interview, review of facility documents, and review of manufacturer’s instructions for use (MIFU), it was determined that the facility failed to ensure that bleach used for cleaning and disinfection of the Home Hemodialysis Training room is not beyond the expiration date. Findings include: On 1/7/25 starting at 11:35 AM, a tour of the Home Hemodialysis Training Room was conducted in the presence of Staff (S) 7, the Home Hemodialysis Nurse. A container of 1:100 bleach solution (one part bleach with 100 parts water) was observed and a further observation revealed a bottle of Pure Bright Germicidal Ultra Bleach concentrate with a ‘Best By date of 03/25/24.’ During an interview at the time of discovery, S7 stated that the Pure Bright Germicidal Ultra Bleach bottle was used to make the 1:100 bleach solution. S7 stated that this solution was used to clean and disinfect all surfaces of the room, including the NxStage hemodialysis machine that patients utilized during training sessions. S7 was unable to confirm how long the bottle of bleach concentrate had been used in this area. S7 confirmed that the bleach was beyond the best by date and stated that it should not be used. S7 immediately disposed of the contents of the Pure Bright Germicidal Ultra Bleach bottle and disposed of the bottle. S7 replaced it with a new bottle that was within the best by date. A review of the schedule for Home Hemodialysis Patient Training was reviewed for October, November, and December 2024 and revealed that Patient (P) 2 trained on Home Hemodialysis Treatments in the facility from 10/14/24 through 10/25/24. P8 trained on Home Hemodialysis Treatments from 10/29/24 through 11/25/24. Facility procedure 12-07-08A, titled “Preparation of One to One Hundred (1:100) Bleach Solution,” revised October 2023, stated, “... Procedure ... Obtain a container of 5.25 - 6.25% unscented household bleach concentrate and verify it has not expired. ... Rationale ... Bleach concentrate used after the expiration date may be ineffective. Refer to manufacturer expiration date of the household bleach. ..” N.J.A.C. 8:43A-24.4(a)”

“POC-MANAGE VOLUME STATUS CFR(s): 494.90(a)(1) The plan of care must address, but not be limited to, the following: (1) Dose of dialysis. The interdisciplinary team must provide the necessary care and services to manage the patient’s volume status; This Standard is not met as evidenced by: 49828 Based on staff interview and review of facility documents, it was determined that the facility medical director failed to ensure that patient reassessments and vital signs, inclusive of pulse rate and blood pressure, are documented every 30 minutes during hemodialysis treatment in accordance with facility policy in two of nine treatments reviewed for Patient (P) 6. Findings include: A review of P6’s medical record revealed the following: P6’s last Plan of Care Meeting was held on 9/14/24, and indicated that the patient was meeting his/her goal of fluid and blood pressure management. On 12/16/24, the “Treatment Details Report” indicated that P6’s initiation of hemodialysis began at 10:40 AM and that treatment was terminated at 2:15 PM. From 11:14 AM to 12:11 AM (53 minutes), the medical record lacked documented evidence of patient assessment (inclusive of visible access, line connections intact, and patients’ overall health status or complaints) and vital signs that were completed every 30 minutes in accordance with facility policy. On 12/29/24, the “Treatment Details Report” indicated that P6’s initiation of hemodialysis began at 10:33 AM and that treatment was terminated at 2:00 PM. From 12:03 PM to 2:00 PM (one hour and 57 minutes), the medical record lacked documented evidence a patient assessment and vital signs that were completed every 30 minutes in accordance with facility policy. During an interview on 1/8/25 at 1:05 PM, Staff (S)1, the Clinical Coordinator stated, “vital signs and patient assessments should be documented every 30 minutes.” S1 confirmed on 12/16/24, and 12/29/24, patient assessments and vital signs were not documented every 30 minutes. Facility policy and procedure titled, “Pre-Intra-Post Treatment Data Collection, Monitoring, and Nursing Assessment,” Revised April 2024, stated, “... Intradialytic Data Collection/Assessment 9. Intradialytic treatment monitoring and data collection which may be performed by the PCT [patient care technician] or licensed nurse includes: ... iii. Non-nocturnal treatments are completed at least every thirty (30) minutes. b. At a minimum, obtain and document the following: i. Blood pressure ii. Heart or pulse rate ... v. Vascular access visible and line connections intact vi. Patient subjection statement(s) i.e., patient report on overall health, any complaints ...” N.J.A.C. 8:43A-24.4(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 two of two observations of the initiation of hemodialysis through an Arteriovenous Fistula (AVF) (a type of vascular access used for hemodialysis), staff interview, and review of facility policy, 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 1/7/25 at 10:04 AM, in Station 4, Staff (S) 9, a Patient Care Technician (PCT), initiated hemodialysis through an AVF. S9 cleansed the first site of the AVF with one alcohol preparation (prep) pad in a circular motion for ten seconds. S9 did not clean the access site for 60 seconds and did not use a total of four alcohol prep pads to cleanse the site per facility policy. S9 cleansed the second site with one alcohol prep pad in a circular motion for five seconds and waved his/her hand back and forth over the access site before inserting the fistula needle. S9 did not clean the access site for 60 seconds and did not use a total of four alcohol prep pads to cleanse the site. S9 also did not let the access site air dry after cleansing the site. During an interview at 10:25 AM, S9 stated that each site should be cleansed with alcohol for 60 seconds. When asked about the dry time for the access site after cleansing S9 said, “I should have waited for the site to air dry. I should not have fan dried the site with my hands.” S9 also confirmed the patient did not have an allergy to iodine or ExSept. A review of S9’s personnel record indicated the Nurse Skills Checklist for cleansing cannulation sites were demonstrated on 6/10/24 and satisfactory performance by a new teammate signed off on 6/10/24. On 01/7/25 at 10:35 AM, in Station 7, S11, a PCT, initiated hemodialysis through an AVF. S11 cleansed the first site of the AVF with one alcohol preparation (prep) pad in a circular motion for 30 seconds. S11 did not clean the access site for 60 seconds and did not use three alcohol prep pads to cleanse the site per facility policy. S11 cleansed the second site with one alcohol prep pad in a circular motion for 30 seconds. S11 did not clean the access site for 60 seconds and did not use a total of four alcohol prep pads to cleanse the site per facility policy. During an interview at 11:00 AM, S11 stated the access site only needed to be cleaned for 30 seconds and only needs one alcohol prep pad per site. When asked about the use of iodine S11 said, “the patient did not have an allergy to iodine but there is no order for iodine to be used.” A review of S11’s personnel record indicated the Nurse Skills Checklist for cleansing cannulation sites were demonstrated on 9/6/24, and satisfactory performance by a new teammate signed off on 9/6/24. During an interview at 11:15 AM, S10 a Registered Nurse (RN), was asked about the process of cleaning a site for an AVF and the use of alcohol or iodine. S10 stated the process should be to use alcohol first to clean the site and then use iodine or ExSept for sensitivity. Facility policy titled, “AV Fistula or Graft Cannulation With Nipro Or Medisystems Safety Fistula Needles (SFN) and Administration of Heparin Loading Dose,” revised October 2022, stated, “Skin Antiseptic ...Isopropyl Alcohol 70 %... Effective Volume ... At least 4 prep pads per site ...Effective Contact Time ... 60 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) 12. For patients who have a documented allergy to povidone iodine or ExSept Plus, necessitating alcohol alone, apply alcohol using a circular rubbing motion, center out for 60 seconds and allow to dry for 15 seconds prior to cannulation ...” N.J.A.C. 8:43A-24.8(b)”

“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: 39223 Based on observations, medical record review, staff interviews, and review of facility documents, it was determined that the Medical Director failed to ensure that: 1) staff label three of five containers of bleach disinfectant solution in accordance with facility policy; 2) the protocol for patients ending treatment early is followed for five of nine treatments reviewed (Patient (P) 6); and 3) all staff administer heparin in accordance with the facility policy on two of two observations of heparin administration. Findings include: 1. On 1/7/25, during a tour of the Hemodialysis Treatment Floor starting at 9:55 AM, the following was observed: At 10:00 AM, a plastic container located on the Dirty Sink countertop across from Station 16, contained a clear liquid. The label on the container identified the liquid as 1:100 bleach (one part bleach to 100 parts water) that was mixed on 1/4/25 at 5:45 AM. At 10:02 AM, a plastic container located on the countertop across from Station 4, contained a clear liquid. The label on the container identified the liquid as 1:100 bleach that was mixed on 1/4/25 at 5:45 AM. At 10:03 AM, a plastic bottle was identified by Staff (S) 5, the Biomedical Technician, as 1:10 bleach. The bottle was labeled with a date of 01/02/25. During interview at the time of discovery, S5 stated that 1:10 bleach is good for one week. S5 confirmed that the 1:100 bleach solution containers should be changed every 24 hours. At 12:15 AM, during an interview with S11, a Patient Care Technician (PCT), he/she stated that he/she had mixed the bleach in both containers that morning. Facility procedure titled, “Preparation of One to One Hundred (1:100) Bleach Solution,” revised October 2023, stated, “... Procedure ... 5. Remove previously applied mixing label, including expiration date, tine and initials, but do not remove the HazCom label. ... 12. With indelible marking pen and label, label container with expiration date, time and initials. The solution is good for 24 hours only. ...” Facility procedure titled, “Preparation of One to Ten (1:10) Bleach Solution,” revised October 2023, stated, “... Procedure ... 5. Remove previously applied mixing label, including expiration date, time and initials, but do not remove HazCom label. ... 12. With indelible marking pen and label, label container with expiration date, time, and initials. The solution is good for 24 hours only. ...” N.J.A.C. 8:43A-24.4(a) 49828 2. A review of P6’s medical record revealed the following: The “In-Center Hemodialysis Treatment” orders stated, “... Frequency/TX [treatment]time Three times a week, [240 mins (minutes)] ... Ordered Activated 11/21/2024 ...” On 12/18/24, the “Treatment Details Report” indicated that P6’s initiation of hemodialysis began at 10:05 AM, and that treatment was terminated at 1:19 PM, 49 minutes earlier than the prescribed treatment time. The “Close Treatment Reason” section revealed, “Patient Choice [AMA (against medical advice), feels unwell/cramping, patient behavior issues].” The medical record lacked documented evidence of a completed Early Termination of Treatment Against Medical Advice form and that P6’s attending nephrologist was notified that the prescribed treatment time was not met. On 12/20/24, the “Treatment Details Report” indicated that P6’s initiation of hemodialysis began at 10:59 AM, and that treatment was terminated at 2:30 PM, 26 minutes earlier than the prescribed treatment time. The “Events and Comments” section revealed, “... treatment ended early as per pt’s [patients] request.” The medical record lacked documented evidence of a completed Early Termination of Treatment Against Medical Advice form. On 12/27/24, the “Treatment Details Report” indicated that P6’s initiation of hemodialysis began at 10:33 AM, and that treatment was terminated at 2:02 PM, 31 minutes earlier than the prescribed treatment time. The medical record lacked documented evidence that P6’s attending nephrologist was notified that the prescribed treatment time was not met. On 12/31/24, the “Treatment Details Report” indicated that P6’s initiation of hemodialysis began at 10:48 AM and that treatment was terminated at 1:17 PM, one hour and 28 minutes earlier than the prescribed treatment time. The medical record lacked documented evidence that P6’s attending nephrologist was notified that the prescribed treatment time was not met. On 1/3/25, the “Treatment Details Report” indicated that P6’s initiation of hemodialysis began at 10:31 AM, and that treatment was terminated at 1:25 PM, one hour and five minutes earlier than the prescribed treatment time. The “Close Treatment Reason” section revealed, “Patient Choice [AMA, feels unwell/cramping, patient behavior issues].” The medical record lacked documented evidence of a completed Early Termination of Treatment Against Medical Advice form and that P6’s attending nephrologist was notified that the prescribed treatment time was not met. On 1/8/25 at 1:00 PM, S1, the Clinical Coordinator stated, “if a patient is shortening treatments the AMA form needs to be completed.” S1 confirmed that there were no completed Early Termination of Treatment Against Medical Advice forms on 12/18/24, 12/20/24, and 1/3/25. Upon request, S1 was unable to provide documented evidence the patients physician was notified of an early termination of treatment exceeding 30 minutes on 12/18/24, 12/27/24, 12/31/24, and 1/3/24. Facility policy and procedure titled, “Prescribed Treatment Time Not Met,” Revised April 2024, stated, “... Policy: A. Completion Of The Early Termination of Treatment Against Medical Advice Form 1. The Registered Nurse [RN] will verify that a patient signs the Early Termination of Treatment Against Medical Advice form any time the patient requests to terminate their treatment earlier than the prescribed run time. ... B. Prescribed Treatment Time Not Met 1. If shortened/early termination of treatment time exceeds 30 or more minutes, the RN will notify the patient’s attending nephrologist ... 3. If a patient’s treatment is shortened/early terminated, the RN will document the event in the patient’s electronic health record. Documentation will include, as appropriate: ... Whether the patient’s nephrologist was notified, A description of the follow-up medical orders provided by the patient’s attending nephrologist [if any] ...” N.J.A.C. 8:43A-24.4(a) 51227 3. On 1/7/25 at 10:04 AM, in Station 4, S9, a Patient Care Technician (PCT), was observed initiating hemodialysis treatment through an arteriovenous fistula (AVF- a type of vascular access used for hemodialysis). S10, a Registered Nurse (RN), attached a heparin filled syringe to the venous needle and slowly injected the heparin with a back-and-forth motion. After waiting 30 seconds, S9 proceeded to attach the dialysis lines to the fistula needles and initiated treatment. This was two minutes and 30 seconds less then the required wait time per facility policy. During an interview at 10:30 AM, S9 stated the wait time after Heparin is given is three to five minutes and confirmed he/she did not wait three minutes before initiating treatment. Facility policy titled, “AV Fistula Or Graft Cannulation with Nipro or Medisystems Safety Fistula Needles (SFN) And Administration Of Heparin Loading Dose,” revised in October 2022, stated, “... 28. Attach heparin loading dose to venous fistula needle, as applicable. Unclamp and gently flush heparin back and forth 3-5 times into fistula or graft. Re-clamp ... 29. Do not initiate dialysis for a minimum of three (3) to five (5) minutes after administering heparin loading dose. ...” On 1/8/25 at 9:30 AM, in Station 1, S8, a RN, was observed initiating hemodialysis treatment through a central venous catheter (CVC). S8 attached a heparin filled syringe to the venous port and slowly injected the heparin with a back-and-forth motion. After waiting one minute, S8 proceeded to attach the dialysis lines to the CVC and initiated treatment. This is two minutes less than the required wait time per facility policy. During an interview at 9:45 AM, S8 stated the wait time after Heparin is given is three to five minutes. Facility policy titled, “Central Venous Catheter (CVC) with Clearguard HD Antimicrobial End Caps Procedure,” revised October 2024, stated, “ ... Procedure: ... 26. Attach heparin loading dose to venous limb, as applicable. Unclamp and gently flush heparin back and forth 3-5 times into catheter. Re-clamp. 27. After a minimum of 3-5 minutes, remove syringe from each access port one at a time, then attach each blood line carefully, as not to contaminate blood line tips or catheter limbs ...” N.J.A.C. 8:43A-24.4(a)”