Davita Somerset Dialysis Center

“IC-IF TO STATION=DISP/DEDICATE OR DISINFECT CFR(s): 494.30(a)(1)(i) Items taken into the dialysis station should either be disposed of, dedicated for use only on a single patient, or cleaned and disinfected before being taken to a common clean area or used on another patient. -- Nondisposable items that cannot be cleaned and disinfected (e.g., adhesive tape, cloth covered blood pressure cuffs) should be dedicated for use only on a single patient. -- Unused medications (including multiple dose vials containing diluents) or supplies (syringes, alcohol swabs, etc.) taken to the patient’s station should be used only for that patient and should not be returned to a common clean area or used on other patients. This Standard is not met as evidenced by: 37913 Based on observation, interview and policy review, it was determined that the facility failed to ensure that all personal care items used by the facility staff for patient care were stored and disinfected between each patient’s use for one of two observation days. Failure to ensure that personal care items are properly stored has the potential to affect 70 in-center patients receiving dialysis treatments at the facility. Findings include: During observation on 04/22/24 at 8:45 AM of the dialysis treatment floor, blood pressure cuffs that were not in use were stored on a shelf within the splash zone (an area designated around the patient’s chairs that could potentially be contaminated by splashing blood) behind Stations 11, 13, and 18; and oxygen concentrators not in use were being stored within the splash zone next to patient’s chairs at Stations 10 and 17. During an interview on 04/22/24 at 9:00 AM, the Clinical Nurse Manager confirmed blood pressure cuffs used for patient care should not be placed or stored within the splash zone and stated that “oxygen concentrators need to be cleaned after each use and moved to a clean area.” Review of the facility’s policy titled, “Infection Control for Dialysis Facilities” revised 04/2023 revealed, “Cleaning and/or disinfection of equipment and work surfaces will be performed as soon as possible following exposure to blood or other potentially infectious materials (i.e., used or brought into the station) and prior to returning to clean/designated area or removal from treatment area ...” N.J.A.C. 8:43A-24.8(b)”

“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: 37913 Based on observation, interviews and policy review, it was determined that the facility failed to ensure that the door leading to the outside adjacent to the water room was sealed preventing insects and rodents from entering the facility. Failure to ensure that the facility is properly maintained has the potential to affect 70 patients receiving in-center dialysis. Findings include: During observation on 04/22/24 at 9:00 AM, the door leading to the outside adjacent to the water room had a half inch gap between the bottom of the door and the floor. During an interview on 04/22/24 at 9:00 AM, the Clinical Nurse Manager confirmed there was a gap at the bottom of the door and agreed that it was an entry point for insects and rodents to enter the facility. During an interview on 04/22/24 at 2:00 PM, Bio-medical Technician (BMT) 2, confirmed there was a gap at the bottom of the door and stated that “we will call a vendor out to repair it.” Review of the facility’s policy titled, “Physical Environment,” revised 04/2018 revealed, “The building in which dialysis services are furnished will be constructed and maintained for the safety of the patients, the teammates, and the public. ... The dialysis facility will implement and maintain a program to verify that all equipment including emergency equipment, dialysis delivery systems and the water treatment systems are maintained and operated in accordance with the manufacturer’s recommendations.” N.J.A.C. 8:43A-17.3(l)”

“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: 37913 Based on observations, interview, and policy review, it was determined that the facility failed to ensure that the floor in the water room and the wall boxes in the clinical area are thoroughly cleaned. Failure to thoroughly clean the water room floor and wall boxes has the potential to affect 70 in-center patients receiving dialysis treatments at the facility. Findings include: 1. During observation on 04/22/24 at 8:45 AM of the dialysis treatment floor, the wall boxes located behind the dialysis chair at Stations 4, 5, 8, 10, and 17 had a hard thickened crystal coating on the bottom of the boxes. During an interview on 04/22/24 at 8:45 AM, the Clinical Nurse Manager confirmed there was a hard thickened crystal coating on the bottom of the wall boxes at Stations 4, 5, 8, 10, and 17. The Clinical Nurse Manager stated, “the wall boxes are required to be monitored and cleaned when necessary.” 2. During observation on 04/22/24 at 9:15 AM of the water room, a black substance was found in and/or around the drains behind the carbon tanks, the hot water tank, and the booster pump. During an interview on 04/22/24 at 9:15 AM, the Clinical Nurse Manager confirmed there was a black substance in and/or around the drains behind the carbon tanks, the hot water tank, and the booster pump. Review of the facility’s policy titled “Physical Environment” revised 04/2018 indicated, “The building in which dialysis services are furnished will be constructed and maintained for the safety of the patients, the teammates, and the public. ... The dialysis facility will implement and maintain a program to verify that all equipment including emergency equipment, dialysis delivery systems and the water treatment systems are maintained and operated in accordance with the manufacturer’s recommendations ...” 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: 37913 Based on observation, interview, manufacturer’s instructions review and policy review, it was determined that the facility failed to ensure expired medical supplies were disposed of during one of three survey days. Failure to remove expired medical supplies has the potential to affect 70 in-center patients receiving dialysis treatments at the facility. Findings include: During observation on 04/22/24 at 9:50 AM in the Laboratory Room, an open package of Diastix Reagent Strips for urinalysis, lot number 003094, expired on 03/07/23, and a package of glucose FreeStyle Test Strips for blood sugar testing, lot number 45001 82583, expired on 02/28/21 were found. During an interview on 04/22/24 at 9:50 AM, the Clinical Nurse Manager confirmed the Diastix Reagent Strips, and the FreeStyle Test Strips were expired and should have been disposed of. Review of the facility’s policy titled, “Infection Control for Dialysis Facilities,” revised 04/2023 indicated, “Supplies will be stored in manner that maintains their integrity ... expiration date and package date integrity will be verified prior to use and anytime the integrity of a package without an expiration date is in question, i.e.., torn, ripped, wet or contaminated, the package and its contents must be disposed of and not used ...” 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: 28297 Based on interview, medical record review, and review of facility policy, it was determined that: 1) the facility failed to ensure a pre-treatment standing blood pressure was completed for four of eight sampled in-center patients (Patient (P) 2, P3, P4 and P8); and 2) the facility failed to document the reason a patient was not set for the physician ordered dry weight pre-treatment or document post-treatment when the patient was not within 1 kilogram of the prescribed dry weight for one of eight sampled patients (P3). The failure to complete pre-treatment standing blood pressure has the potential for staff to not know the patients baseline standing blood pressure that could impact the patient dialysis treatment and could affect 70 in-center patients. The failure to set the patient for the physician ordered dry weight has the potential for patients to have excess fluid that could result in adverse events or unnecessary hospitalization and could affect 70 in-center patients. Findings include: 1. Review of the medical record for P2 revealed the facility admitted the patient on 03/04/24 with the diagnosis of end stage renal disease (ESRD). Review of the treatment flow sheets from 04/08/24-04/19/24 revealed a pre-treatment standing blood pressure was not taken on 04/08/24, 04/10/24, 04/12/24, 04/17/24 and 04/19/24. There was no documentation of the reason the pre-treatment standing blood pressure was not taken by the staff. Review of the medical record for P3 revealed the facility admitted the patient on 03/04/24 with the diagnosis of ESRD. Review of the treatment flow sheets from 04/08/24-04/19/24 revealed a pre-treatment standing blood pressure was not taken on 04/12/24, 04/17/24 and 04/19/24. There was no documentation of the reason the pre-treatment standing blood pressure was not taken by the staff. Review of the medical record for P4 revealed the facility admitted the patient on 03/08/22 with the diagnosis of ESRD. Review of the treatment flow sheets from 04/08/24-04/19/24 revealed a pre-treatment standing blood pressure was not taken on 04/10/24, 04/12/24 and 04/15/24. There was no documentation of the reason the pre-treatment standing blood pressure was not taken by the staff. Review of the medical record for P8 revealed the facility admitted the patient on 04/13/23 with the diagnosis of ESRD. Review of the treatment flow sheets from 04/11/24-04/23/24 revealed a pre-treatment standing blood pressure was not taken on 04/11/24, 04/13/24, 04/16/24, 04/18/24 and 04/20/24. There was no documentation of the reason the pre-treatment standing blood pressure was not taken by the staff. During an interview on 04/24/24 at 9:30 AM, Patient Care Technician (PCT)13 confirmed that he/she had not taken pre-treatment standing blood pressures on some identified patients flowsheets. PCT13 stated he/she was new and didn’t know he/she had to document if the patient refused a standing blood pressure. PCT13 also stated that some patients just come in and sit down and he/she didn’t know they needed to ask the patient to do a standing blood pressure if able. During an interview on 04/24/24 at 12:0 PM, Licensed Practical Nurse (LPN)10 confirmed that he/she had not taken pre-treatment blood pressures on some identified patients flowsheets. LPN10 stated that some patients refuse a standing blood pressure and he/she should have documented and reported to the Registered Nurse (RN). During an interview on 04/24/24 at 12:10 PM, the Clinical Nurse Manager stated he/she had completed flowsheet audits and identified missed pre-treatment blood pressures and staff had been in-serviced previously but didn’t document the training. He/she confirmed the missing pre-standing blood pressures on all the flowsheets reviewed and stated when patients refuse a standing blood pressure it must be documented and reported to the RN. The Clinical Nurse Manager stated it was important to do a pre-treatment standing blood pressure to get the patients baseline. 2. Review of the medical record for P3 revealed the facility admitted the patient on 03/04/24, with the diagnosis of ESRD. Review of the treatment flow sheets from 04/08/24-04/19/24 revealed the patient was not set to remove fluid to dry weight for the dates as follows: On 04/08/24, the patients’ pre-weight was 65.3 kilograms (kg) and post weight was 64.9 kg with a dry weight of 60.5 kg. 1000 milliliters of fluid was removed and the post-weight was over the dry weight by 4.4 kilograms. On 04/10/24, the patients’ pre-weight was 64.3 kg and post weight was 63.9 kg with a dry weight of 60.5 kg. 1000 milliliters of fluid was removed and the post-weight was over the dry weight by 3.4 kilograms. On 04/12/24, the patients’ pre-weight was 65.1 kg and post weight was 64.6 with a dry weight of 60.5 kg. 1300 milliliters of fluid was removed and the post-weight was over the dry weight by 4.1 kilograms. On 04/17/24, the patients’ pre-weight was 63.5 kg and post weight was 62.5 kg with a dry weight of 60.5 kg. 1000 milliliters of fluid was removed and the post-weight was over the dry weight by 2.0 kilograms. On 04/19/24, the patients’ pre-weight was 65.2 kg and post weight was 64.1 kg with a dry weight of 60.5 kg. 1200 milliliters of fluid was removed and the post-weight was over the dry weight by 3.6 kilograms. LPN10 was the nurse to initiate the treatment on 04/19/24, 04/17/24, and 04/12/24. During an interview on 04/24/24 at 12:00 PM, LPN10 confirmed he/she was the nurse who put P3 on treatment on 04/12/24, 04/17/24 and 04/19/24. LPN10 stated the patient requested to only remove 1000 milliliters because he/she would cramp or feel bad. LPN10 acknowledged he/she did not document the patients request or that the RN was notified. During an interview on 04/24/24 at 12:10 PM, the Clinical Nurse Manager confirmed the flowsheets for P3 where the patient was not set to the dry weight and there was no documentation of the reason on the flow sheets. He/she also confirmed there were no nurses progress notes documented regarding P3’s fluid removal and not meeting dry weight for the past month. The Clinical Nurse Manager stated its import to address the patient dialysis prescription to ensure the patient prescription is followed and if not, then the Physician was to be notified. Review of the facility policy titled, “Pre-Intra-Post Treatment Data Collection, Monitoring, and Nursing Assessment,” revised April 2024 indicated, “ ...Patient Data will be obtained and documented by the patient care technician or licensed nurse. A .Data collection includes but is not necessarily limited to: ...Measurement of Blood Pressure (BP) Sitting and standing BP measurement required pre and post treatment (if patient unable to stand, document reason in the patient electronic record or flow sheet) ...Patient weight ...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. 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. Prescription components include but are not necessarily limited ...Target weight ...If the dialysis prescription is not being met (including dialysis flow rate or change/inability to obtain prescribed blood flow rate) the reason will be documented, and the licensed nurse informed. Abnormal findings or findings outside of any patient specific physician ordered parameters will be reported to the licensed nurse immediately (refer to “Abnormal Findings” section in this policy). The licensed nurse will use his/her clinical judgement based on individual patient needs to determine if any clinical interventions are necessary. The licensed nurse notifies the physician (or NPP if applicable) as needed of changes in patient status ...Post Treatment Data Collection Assessment ...Abnormal Findings ...the following are considered abnormal findings and should be reported to the licensed nurse and documented in the patients’ medical record ...Post-treatment: If patient is above or below 1kg from the target weight ...” N.J.A.C. 8:43A-24.4(a)”

“MR-COMPLETE, ACCURATE, ACCESSIBLE CFR(s): 494.170 The dialysis facility must maintain complete, accurate, and accessible records on all patients, including home patients who elect to receive dialysis supplies and equipment from a supplier that is not a provider of ESRD services and all other home dialysis patients whose care is under the supervision of the facility. This Standard is not met as evidenced by: 37913 Based on observation, record review, interviews, and policy review, it was determined that the facility failed to ensure that blood loss at the end of treatment decannulation (removing of the needle used during the dialysis treatment) of one (Patient (P) 11) of five patients observed for decannulation was documented. Findings include: During observation on 04/22/24 at 9:20 AM, Registered Nurse (RN)6 removed P11’s dialysis needle and then placed a clamp on the access to apply pressure on the wound in the arm that the needle created. P11’s access site continued to bleed, and blood was leaking around the clamp onto the floor. Review of P11’s treatment sheet for 04/24/24, revealed no documentation of P11’s estimated blood loss at the end of treatment. During an interview on 04/24/24 at 8:30 AM, the Facility Administrator confirmed that all bleeding events, even small amounts of blood loss that do not require an adverse occurrence report to be generated are required to be documented. During an interview on 04/24/24 at 9:00 AM, RN6 indicated he/she did not document the bleeding after removing P11’s dialysis needle because it was only 10 or 15 milliliters (ml) of blood and he/she just did not think about documenting the occurrence. RN 6 then stated, “I am aware that facility staff are required to document any blood loss occurrence.” Review of the facility’s policy titled “Pre-intra-post treatment data collection, monitoring and nursing assessment” revised 04/2023, revealed, “Unless other abnormal parameters are established by the facility governing body and documented in the governing body minutes, the following are considered abnormal finding and should be reported to the licensed nurse and documented in the patient’s medical record ... any swelling , pain, redness, warm to touch, pustules, sores, open areas, hematoma, new aneurysm or changes to existing aneurysm, bleeding or reduced or absent thrill or bruit.” N.J.A.C. 8:43A-24.4(a)”