Davita Woodbridge Dialysis Center

“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: 27438 Based on observation, interview, and review of the facility’s policy, it was determined that the facility failed to ensure that eight of 19 dialysis chairs were disinfected for the next patient’s use. This deficient practice has the potential to cause harm by transmission of bloodborne pathogens (infectious microorganisms in human blood that can cause disease in humans) which could negatively impact the 99 patients receiving in-center dialysis treatments in this facility. Findings include: During an observation on 02/28/24 between 9:20 AM and 10:00 AM, the dialysis station chair armrest at Station’s 1, 5, 6, 10, 12, 16, and 17, were worn exposing the absorbent material. Station 11 was observed to have an 11-centimeter (cm) (unit of measurement) rip in the center of the back cushion exposing absorbent material. Observation revealed all worn areas and tears exposed the absorbent materials. During an interview on 02/28/24 at 9:35 AM, Patient (P) 11 confirmed the material at Station 6 on the right armrest was worn, he/she stated, “The arms are chewed up and the seats hurt to sit in.” During an interview on 02/28/24 at 10:15 AM, the Facility Administrator confirmed the facility was aware that the dialysis station treatment chairs were worn and exposed absorbent material which could not be disinfected. During an interview on 02/28/24 at 11:55 AM, the Medical Director confirmed the facility was aware that the dialysis station treatment chairs were worn and exposed absorbent material, however he/she was not aware of the extent of dialysis chairs involved. Review of the facility’s policy titled, “Infection Control for Dialysis Facilities,” revision date October 2021, indicated, “Equipment including. . .the dialysis chair and side tables including opening the chair to reach crevices. . .will be wiped clean with a bleach solution of the appropriate strength after completion of procedures, before being used on another patient, after spills of blood, throughout the workday, and after each treatment.” N.J.A.C. 8:43A-24.4(a)”

“ENVIRONMENT-SECURE & RESTRICTED CFR(s): 494.40(a) 8 Environment: secure & restricted The water purification and storage system should be located in a secure area that is readily accessible to authorized users. The location should be chosen with a view to minimizing the length and complexity of the distribution system. Access to the purification system should be restricted to those individuals responsible for monitoring and maintenance of the system. This Standard is not met as evidenced by: 27438 Based on observation, interview, and review of the facility’s policy, it was determined that the facility failed to restrict access to the water purification room to only authorized users. Failure to restrict access to the water purification room to only authorized users who were responsible for monitoring and maintaining the water purification, has the potential to negatively impact the safety and well-being of the 99 in-center dialysis patients receiving treatments at this facility. Findings include: During the flash tour observation on 02/26/24 at 8:30 AM, the Clinical Nurse Manager used a three-digit keyless security code to unlock the door to enter the patient treatment area. Upon completing a tour of the patient treatment area, the Clinical Nurse Manager used the same three-digit keyless security code to enter the designated water purification system room. The Clinical Nurse Manager confirmed at that time that the same three-digit keyless security code opened both the patient treatment door and the water purification system room door. During an interview on 02/26/24 at 9:15 AM, the Facility Administrator confirmed the three-digit keyless security code used for patient treatment room door and the water purification system room door had been programmed with the same three numbers. The Facility Administrator stated he/she was aware the codes needed to be different. However, the Facility Administrator stated he/she was not aware that both security doors had been programmed with the same code. During an interview on 02/26/24 at 10:00 AM, the Biomedical Technician confirmed not all facility staff are trained and/or authorized to operate facility water purification system and the security door to the water purification system should be programmed differently. Review of the facility’s policy titled, “Water Treatment Systems Minimum Component Requirement,” revised October 2021, indicated, “Access to the water treatment system should be restricted to those personnel/trained teammates responsible for monitoring, maintenance of the system and supply ordering.” N.J.A.C. 8:43A-24.10(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: 27438 Based on observation, interview, and review of the facility’s documents and policy, it was determined that the facility failed to maintain the patient dialysis treatment chairs in good working order. Failure to maintain 12 of 19 treatment chairs has the potential to negatively impact the safety and wellbeing of all 99 in-center hemodialysis patients. Findings include: During an observation on 02/28/24 between 9:20 AM and 10:00 AM, revealed 19 dialysis stations with a reclining treatment chair for patient use. Observation of Station’s 1, 5, 6, 10, 11, 12, 16, and 17, revealed the dialysis station chair armrest or back materials were worn or torn. Observation of Station’s 5, 6, 7, 8, and 14 revealed the seat cushion was sunken and not supportive for patient use. Dialysis chairs at Station’s 14 and 16 had mechanical issues with the reclining mechanism. During an interview on 02/28/24 at 9:20 AM, Patient (P) 14 reported the dialysis chair at Station 13 could not be reclined unless leaning against the center partition, stating, “The chair back is broken and has to lean back on the wall, or it will fall back flat.” During an interview on 02/28/24 at 9:20 AM, P16 reported the dialysis chair at Station 7 could not be reclined unless with caution, stating, “When reclining the chair, it will fall back if you’re not careful.” During an interview on 02/28/24 at 9:35 AM, P11 confirmed the worn chair material at Station 6 on the right arm rest under the area he/she was resting his/her hand, stating, “The arms are chewed up and the seats hurt to sit in. I have to bring in my own pillow to sit on to keep my backside from hurting.” During an interview on 02/28/24 at 10:20 AM, the Facility Administrator confirmed he/she was aware of the dialysis chair issues and verified the dialysis chairs are to be in good working order. During an interview on 02/28/24 at 11:55 AM, the Medical Director confirmed the facility was aware of the dialysis station treatment chairs had worn, however he/she was not aware of the of the mechanical issues of the and the extent of dialysis chairs involved. The Medical Director confirmed the expectation of the facility was all dialysis chairs should be in good working order. Review of the facility document titled, “Monthly OSHA [Occupational Safety and Health Administration] & Safety Checklist,” dated 02/15/24, indicated, “. . .Question 43 Are all patient treatment chairs in good working condition? No, some chairs have ripped leather or are not fully opening/closing.” Review of the facility’s policy titled, “Physical Environment,” revision date April 2018, indicated, “The dialysis facility will be designed, constructed, equipped, and maintained to provide dialysis patients, teammates, and the public a safe, functional, and comfortable treatment environment. 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: 27438 Based on record review, interview, and facility policy review, it was determined that the facility staff failed to monitor and/or document patient intradialytic (blood pressure, pulse, patient reported symptoms, or interventions) findings during treatments as required for six of nine in-center patients (Patient (P)1, P3, P4, P5, P7, and P9) treatment records reviewed. Failure to monitor and/or document treatment findings has the potential to negatively impact the effectiveness of the dialysis treatment for the six patients. Findings include: 1. Review of P1’s “Treatment Details Report” forms, found in the electronic medical record (EMR), revealed one of six printed “Treatment Details Reports” from 02/12/24 through 02/23/24, indicated the following: a. On 02/21/24 from 7:55 AM until 8:55 AM (60 minutes), facility staff failed to document intradialytic findings during dialysis treatment. 2. Review of P3’s “Treatment Details Report” forms, found in the EMR, revealed four of six printed “Treatment Details Reports” from 02/03/24 through 02/22/24, indicated the following: a. On 02/22/24 from 2:54 PM until 5:54 PM (180 minutes), facility staff failed to document intradialytic findings during hemodialysis. b. On 02/19/24 from 3:34 PM until 6:34 PM (180 minutes), facility staff failed to document intradialytic findings during hemodialysis. c. On 02/10/24 from 2:56 PM until 5:12 PM (138 minutes), facility staff failed to document intradialytic findings during hemodialysis. 3. Review of P4’s “Treatment Details Report” forms, found in the EMR, revealed one of six printed “Treatment Details Reports” from 02/10/24 through 02/24/24, indicated the following: a. On 02/22/24 from 3:07 PM until 6:07 PM (180 minutes), facility staff failed to document intradialytic findings during hemodialysis. 4. Review of P5’s “Treatment Details Report” forms, found in the EMR, revealed one of six printed “Treatment Details Reports” from 02/13/24 through 02/24/24, indicated the following: a. On 02/22/24 from 3:07 PM until 6:07 PM (180 minutes), facility staff failed to document intradialytic findings during hemodialysis. 5. Review of P7’s “Treatment Details Report” forms, found in the EMR, revealed one of six printed “Treatment Details Reports” from 02/12/24 through 02/23/24, indicated the following: a. On 02/21/24 from 8:07 AM until 9:36 AM (89 minutes), facility staff failed to document intradialytic findings during hemodialysis. 6. Review of P9’s “Treatment Details Report” forms, found in the EMR, revealed one of six printed “Treatment Details Reports” from 02/10/24 through 02/24/24, indicated the following: a. On 02/22/24 from 11:45 AM until 3:06 PM (180 minutes), facility staff failed to document intradialytic findings during hemodialysis. During an interview on 02/27/24 at 3:40 PM, Manager of Clinical Services reviewed the intradialytic findings for P1, P3, P4, P5, P7, and P9 and verified the missing intradialytic documentation. The Manager of Clinical Services verified staff are required to monitor and document patient observations every 30 minutes. During an interview on 02/28/24 at 11:05 AM, the Medical Director revealed that he/she expects all vital signs and other data to be monitored and documented during 30-minute observations of the patients. During an interview on 02/28/24 at 12:10 PM, Registered Nurse (RN)5 revealed the staff are required to document intradialytic monitoring and data collection every 30 minutes per the facility policy. During an interview on 02/28/24 at 12:45 PM, Certified Clinical Dialysis Technician (CCHT)10 revealed the staff are required to document monitor intradialytic monitoring and data collection every 30 minutes per the facility policy. Review of the facility’s policy titled, “CWOW [Center With Out Walls] -Pre-Intra-Post Treatment Data Collection, monitoring, and Nursing Assessment,” revised April 2021, indicated, “Intradialytic treatment monitoring and data collection which may be performed by the Patient Care Technician (PCT) or licensed nurse includes vital signs and treatment monitoring, for non-nocturnal treatments is completed at least every thirty (30) minutes.” N.J.A.C. 8:43A-24.4(a)”

“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: 27438 Based on record reviews, interview, and policy review, it was determined that the facility failed to follow the individualized dialysis (an artificial means of kidney function that removes the waste and excess fluid from the blood by passing through a filter) prescription as determined by the medical provider for four of nine sampled in-center patients (Patient (P) 3, P4, P5, and P9). Failure to follow the medical providers’ dialysis prescription has the potential to negatively impact the effectiveness of the prescribed dialysis treatments for the all 99 patients receiving in-center dialysis treatments at this facility. Findings include: 1. Review of P3’s “Treatment Details Report” forms, found in the electronic medical record (EMR), revealed two of six printed “Treatment Details Reports” from 02/03/24 through 02/22/24, indicated the following: a. On 02/22/24, the staff failed to follow the dialysis prescription Blood Flow Rate (BFR) of 400 milliliters per minute (ml/min) when during treatment the BFR remained at 350 ml/min. b. On 02/19/24, the staff failed to follow the dialysis prescription BFR of 400 ml/min when during treatment the BFR remained at 350 ml/min. There was no documented rationale for the change to the prescribed BFR. 2. Review of P4’s “Treatment Details Report” forms, found in the EMR, revealed one of six printed “Treatment Details Reports” from 02/10/24 through 02/24/24, indicated the following: a. On 02/22/24, the staff failed to follow the dialysis prescription Dialysis Flow Rate (DFR) of 800 ml/min when during treatment the DFR remained at 500 ml/min. There was no documented rationale for the change to the prescribed DFR. 3. Review of P5’s “Treatment Details Report” forms, found in the EMR, revealed one of six printed “Treatment Details Reports” from 02/13/24 through 02/24/24, indicated the following: a. On 02/22/24, the staff failed to follow the dialysis prescription DFR of 600 ml/min when during treatment the DFR remained at 600 ml/min. There was no documented rationale for the change to the prescribed DFR. 4. Review of P9’s “Treatment Details Report” forms, found in the EMR, revealed one of six printed “Treatment Details Reports” from 02/10/24 through 02/24/24, indicated the following: a. On 02/22/24 the staff failed to follow the dialysis prescription BFR of 350 ml/min when during treatment the BFR remained at 300 ml/min. There was no documented rationale for the change to the prescribed BFR. During an interview on 02/27/24 at 3:40 PM, Manager of Clinical Services reviewed the BFR and DFR findings for P3, P4, P5, and P9 and verified the discrepancy between the prescription and the machine generated BFR and DFR documentation. The Manager of Clinical Services verified staff are required to monitor observations of the machine settings every 30 minutes. During an interview on 02/28/24 at 11:05 AM, the Medical Director revealed that he/she expects all treatment prescriptions for patients to be followed. During an interview on 02/28/24 at 12:10 PM, Registered Nurse (RN)5 revealed the staff are required to observe and change the DFR or BFR when different than the prescription during the observations. Review of the facility’s policy titled, “CWOW [Center With Out Walls] -Pre-Intra-Post Treatment Data Collection, monitoring, and Nursing Assessment,” revised April 2021, indicated, “Patient identity, prescription and machine settings are verified by teammate prior to initiation of treatment with the exception of blood flow rate which is verified and documented when the ordered rate is obtained after onset of treatment.” N.J.A.C. 8:43A-24.4(a)”

“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: 27438 Based on observation, interview, and review of the facility’s policy, it was determined that the facility failed to ensure that staff followed the medication labeling policy for one of three survey dates. This deficient practice has the potential to affect the potency of the medication and could affect all 99 in-center hemodialysis patients receiving treatment at this facility. Findings include: Observation of the facility’s Medication Preparation Room on 02/26/24 at 3:10 PM showed the following open injectable medication without the date and time: Epogen (injectable medication used to treat anemia) 20,000 units (amount of medication) 2 milliliter (ml)measurement of volume) vial. During an interview on 02/26/24 at 3:15 PM, Registered Nurse (RN) 10 stated the nursing staff using medications in the medication room are required to date and initial all multi dose medications when opened. A review of the facility’s policy titled, “Medication Policy,” revised October 2023, indicated, “Each vial is labeled with the initials of the person opening the vial and the expiration date.” N.J.A.C. 8:43A-9.3(a)”