Davita St. Joseph’s Wayne Dialysis

“CFC-INFECTION CONTROL CFR(s): 494.30 This Condition is not met as evidenced by: 36420 Based on observation, review of facility documents, medical record review, and staff interviews, it was determined that the facility failed to ensure that: 1) a designated “dirty sink” is not located within a patient station (V Tag 0111); 2) that after use, any non-disposable equipment brought into the dialysis station is disinfected before being removed from the dialysis station (V Tag 0116); 3) the priming bucket is cleaned and disinfected in between patient treatments (V Tag 0122); 4) expired medications are not available for use (V Tag 0143); and, 5) the threads of the catheter are cleaned adequately when initiating hemodialysis (V Tag 0147). Cross Reference: Condition for Coverage (CfC): 494.30 - Infection Control”

“Means of Egress - General CFR(s): NFPA 101 Means of Egress - General Aisles, passageways, corridors, exit discharges, exit locations, and accesses are in accordance with Chapter 7, and the means of egress is continuously maintained free of all obstructions to full instant use in case of emergency, unless modified by 20/21.2.2 through 20/21.2.11. 20.2.1, 21.2.1, 7.1.10.1 This Standard is not met as evidenced by: 33557 Based on observation and staff interview on 8/8/24, it was determined that the facility failed to ensure corridors leading to exits remain free of obstructions. Findings include: At 10:55 AM in the presence Staff (S) 5, Biomedical Technician, the following items were found to be stored in the corridor outside the Patient Treatment Floor: two hospital style rolling patient beds, three rolling patient treatment chairs, and one wheelchair. S5 confirmed the above finding.”

“Fire Alarm System - Installation CFR(s): NFPA 101 Fire Alarm - Installation A fire alarm system is installed with systems and components approved for the purpose in accordance with NFPA 70, National Electric Code, and NFPA 72, National Fire Alarm Code to provide effective warning of fire in any part of the building. In areas not continuously occupied, detection is installed at each fire alarm control unit. In new occupancy, detection is also installed at notification appliance circuit power extenders, and supervising station transmitting equipment. Fire alarm system wiring or other transmission paths are monitored for integrity. 20.3.4.2.1, 21.3.4.1, 9.6 This Standard is not met as evidenced by: 33557 Based on observation and staff interview on 8/8/24, it was determined that the facility failed to ensure rooms with fire alarm control units are protected by fire detection equipment. Findings include: At 11:11 AM in the presence of Staff (S) 5, Biomedical Technician, the Electrical Room contained the Fire Alarm Control Panel and lacked fire detection. During an interview, S5 confirmed the Electrical Room lacked smoke detection.”

“Subdivision of Building Spaces - Smoke Compar CFR(s): NFPA 101 Subdivision of Building Spaces - Smoke Compartments Smoke compartments do not exceed 25,000 square feet in size. Every story shall be divided into not less than 2 smoke compartments unless one of the following conditions occur: Facility is less than 5,000 square feet protected by an approved smoke detection system Facility is less than 10,000 square feet protected by an approved, supervised sprinkler system per 9.7 Adjoining occupancy is used as a smoke compartment if all of the following are met: a. Separating wall is 1 hour fire resistive rated b. Doors in the 1 hour rated wall at 1-3/4 inches thick c. Doors in the 1 hour rated wall are self-closing d. Windows in the 1 hour rated wall are fixed fire window assemblies per 8.3 e. The ambulatory health care facility is less than 22,500 square feet f. Access from the ambulatory health care facility is unrestricted to another occupancy 20.3.7.2, 21.3.7.2 This Standard is not met as evidenced by: 33557 Based on observations and staff interview on 8/8/24, it was determined that the facility failed to ensure doors in smoke barriers are self-closing. Findings include: At 11:07 AM in the presence of Staff (S) 5, Biomedical Technician, a 3/4 hour fire rated door located in the corridor outside the Exam Room was found held open with a rubber wedge. This wedge was placed between the bottom of the door and the floor preventing the door located in the smoke barrier from self-closing. During an interview at 11:07 AM, S5 stated, “this door should be closed.””

“IC-SANITARY ENVIRONMENT CFR(s): 494.30 The dialysis facility must provide and monitor a sanitary environment to minimize the transmission of infectious agents within and between the unit and any adjacent hospital or other public areas. This Standard is not met as evidenced by: 36420 Based on observation, review of facility documents, medical record review, and staff interview, it was determined that the facility failed to ensure that a designated “dirty sink” is not located within a patient station for one of one “dirty sink” observed. Findings include: During a tour of the hemodialysis treatment floor on 8/7/24, the facility had a designated “dirty sink” located within Station 14. There was no other “dirty” or utility sink available on the hemodialysis treatment floor for disposing of waste fluids. Therefore, all waste fluids would need to be disposed of within the patient treatment station. A review of the patient treatment schedule revealed that a total of four patients were scheduled to receive hemodialysis treatments in Station 14 on 8/5 and 8/6/24. A review of the hemodialysis flowsheets for two of four of those patients (Patient (P) 8 and P9) revealed that the patients received their hemodialysis treatment in Station 14, where the dirty sink was located. During an interview on 8/7/24 at 1:38 PM, with Staff (S) 3, Manager Clinical Services, and S2, Facility Administrator, staff were asked about the dirty sink in Station 14 and the construction of a new sink that was to be completed in accordance with the facilities Plan of Correction that was submitted following a survey conducted in 2021. Staff stated that a new sink was constructed across from Station 14, but that it was designated as a “clean” sink for handwashing. S3 stated that he/she had questioned the location of the “dirty” sink in the past. S3 stated that he/she would have to look into what happened with the sink and the relocation of the “dirty” sink in Station 14 that was supposed to have been completed following the 2021 survey. During an interview on 8/8/24 at 12:00 PM, S3 stated that he/she does the infection control audits for the facility and stated that the Certified Infection Control Professionals (ICP) for the facility had not been to the facility within the past year. S3 stated that the new sink was constructed about a year ago. S3 also stated that the “dirty sink” in Station 14 was being completely closed off and the handwashing sink across from it had now been designated as the “dirty sink.” The facility “Infection Control Quick Reference Guide All Modalities” states, “... Facility Hygiene ... Sinks ... Patients may be exposed to organisms in drains when water splashes from the drain. Splashes may occur when water flow hits the contaminated drain cover or when a toilet or hopper is flushed. Splashes can lead to dissemination of MRDO [multi drug resistant organism]-containing droplets, which in turn may contaminate the local environment or the skin of nearby healthcare personnel and patients. ... Used or contaminated items should be handled in designated utility sinks. ...” N.J.A.C. 8:43A-24.8(d)”

“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: 38289 Based on one of one observation of the initiation of dialysis via a central venous catheter (CVC), staff interview, and a review of facility policy, it was determined that the facility failed to ensure that after use, any non-disposable equipment brought into the dialysis station is cleaned and disinfected before being removed from the dialysis station. Findings include: On 8/7/24 at 11:07 AM, Staff (S) 8, Registered Nurse (RN), was preparing for the procedure to initiate dialysis at Station #12. Simultaneously, S9, Dialysis Technician, was cleaning and disinfecting Station 11, which was adjacent to Station 12. A portable computer desk with monitor and keyboard was located in between Stations 11 and 12. S9 stated that the computer is shared between the two stations and has to be cleaned and disinfected after each patient’s dialysis treatment. S9 also stated that he/she had not yet cleaned the computer desk, and a bleach soaked cloth had been placed on the desk to identify that he/she still needed to clean it. At 11:10 AM, S8 took the hand sanitizer that was on top of a cart at the nurse’s station and placed the hand sanitizer on top of a paper towel on the dirty computer desk. S9 asked for S8 to remove the items as the desk was not cleaned, but S8 walked away without removing items. S9 without disinfecting the hand sanitizer bottle, removed the bottle and placed it back on top of a different cart at the nurse’s station next to clean supplies. At 11:30 AM, S8 was observed taking a different hand sanitizer bottle and placing in on the now clean computer desk in between Station 11 and Station 12. At 11:56 AM, after the completion of the initiation of dialysis procedure, S8 took a bleach soaked cloth and wiped down the hand sanitizer bottle. S8 confirmed that since the hand sanitizer was brought into the station, it should be cleaned and disinfected upon removing it from the station and placing it for general use. S8 was unaware that the first hand sanitizer was not cleaned or disinfected prior to placing on the clean cart. Review of facility policy and procedure titled, “Infection Control for Dialysis Facilities,” revised April 2023, stated, “... 14. Non-disposable items are to be disinfected... prior to removal from treatment/training area and if contaminated between uses ...” 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: 38289 Based on one of two observations for the cleaning and disinfection of the hemodialysis treatment station, staff interview, and a review of facility policy, it was determined that the facility failed to ensure that the priming bucket is cleaned and disinfected in between patient treatments. Findings include: On 8/7/24 at 10:28 AM, Staff (S) 11, a Registered Nurse (RN), a was observed completing the cleaning and disinfection of Station 17. At 10:38 AM, S11 stated that the cleaning and disinfection was completed and he/she left the station to get a new filter, tubing, and intravenous fluids (IVF) to hang for the next patient. The prime bucket still contained clear liquid from the previous patient. At 10:40 AM, S11, returned to the station and proceeded to hand the tubing including clamping one of the ends of the priming tubing into the prime bucket with the clear liquid. Upon interview, when questioned when the prime bucket is cleaned during the cleaning and disinfection of the station, S11 stated that it is the first thing that is emptied and wiped in the process. S11 was shown that the prime bucket still contained clear liquid. S11 stated, “I didn’t realize that I did not empty it.” S11 then emptied and wiped the prime bucket, but continued to use the same tubing that was used prior to the prime bucket being disinfected. S11 was then asked whether he/she would consider the tubing clean or dirty. S11 at first stated it was still clean because he/she had not primed the tubing, then he/she stated that it was dirty because it went into the dirty prime bucket. S11 then changed out the tubing. Review of facility policy titled, “Infection Control for Dialysis Facilities,” revised April 2023, stated, “... 13. At the end of each treatment, the dialysis station/training will be cleaned and disinfected ... a. ... ii. Priming containers are to be emptied prior to disinfection ...” N.J.A.C. 8:43A-24.8(b)”

“IC-ASEPTIC TECHNIQUES FOR IV MEDS CFR(s): 494.30(b)(2) [The facility must-] (2) Ensure that clinical staff demonstrate compliance with current aseptic techniques when dispensing and administering intravenous medications from vials and ampules; and This Standard is not met as evidenced by: 37656 Based on observation of 50 of 50 expired medication vials, staff interview, and review of facility policy, it was determined that the facility failed to ensure that expired medications are not available for use. Findings include: On 8/7/24 at 11:55 AM, during inspection of the Medication Room, there were 30 unopened vials of Vancomycin 500 mg (milligram)/vial that contained an expiration date of June 1, 2024, and 20 vials of unopened Vancomycin 1000 mg (one Gram) with an expiration date of August 1, 2024. Upon interview on 8/7/24 at 12:00 PM, Staff (S) 4, Charge Nurse, confirmed the above findings and disposed of the expired medications after interview. A review of the facility policy titled, “Medication Policy,” revised October 2022, states, “... 31. Medications are ordered and replaced prior to expiration. Unless an exact expiration date is specified, medications with an expiration date of month/year are considered expired the last day of the stated month. ... 32. Disposal of expired medications, including all over the counter and nutritional product samples are removed from the treatment and inventory areas and disposed of per state/local regulations. ...” N.J.A.C. 8:43A-9.3(a)”

“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: 38289 Based on one of one observation of the initiation of hemodialysis using a central venous catheter (CVC), review of facility documents, and staff interview, it was determined the facility failed to ensure the threads of the catheter are cleaned adequately when initiating hemodialysis. Findings include: On 8/7/24 at 11:30 AM at Station 12, Staff (S) 8, a Registered Nurse (RN), initiated hemodialysis through a CVC. S8 removed the arterial thread cap, scrubbed the threads and the end for seven seconds with an alcohol prep pad and then attached a syringe to the arterial limb. S8 proceeded to remove the venous thread cap and scrub the threads and end of the venous hub for five seconds and then attached a syringe to the venous limb. S8 did not clean the arterial and venous ends of the hub for 15 seconds as required by facility policy. During an interview at 12:00 PM, S8 was asked about the procedure on how to clean the threads on the ends of the catheter limbs and S8 explained that he/she was not aware of what the facility policy directed. S8 stated that he/she counts to “about 10 swabs back and forth” and can tell its clean by “the feel of it.” S8 stated that he/she was not aware of any other technique. A review of the facility policy titled, “Central Venous Catheter (CVC) with Clearguard HD Antimicrobial End Caps Procedure,” revised October 2023, stated, “... Procedure ... 16. 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 ... Hold the limbs until the antiseptic has dried ...” 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: 48966 Based on review of one of two medical records, staff interviews, and review of facility policy, it was determined that the facility failed to ensure that staff followed the physician’s hemodialysis prescription orders for the blood flow rate (BFR) in three of six hemodialysis treatments reviewed for (Patient (P) 4). Findings include: A review of P4’s hemodialysis treatment flowsheets revealed the following: P4 had a right upper arm fistula placed on 5/2/24. Cannulation of the new fistula began in July with 17 gauge needles. The “Dialysis Prescription” dated 7/16/24 and 7/18/24, indicated, “BFR 200 ml/min (millimeters per minute).” On 7/16/24, the BFR was documented as 350 mL/min from 9:59 AM until 10:27 AM. The BFR was documented as 230 ml/min from 10:52 AM until the end of treatment at 1:30 PM. On 7/18/24, the BFR was documented as 350 mL/min from 9:57 AM until 11:58 AM. The BFR was documented as 220 ml/min from 12:05 PM until the end of treatment at 1:28 PM. The “Dialysis Prescription” dated 7/23/24, indicated, “BFR 250 ml/min.” The BFR was documented as 300 mL/min from 9:49 AM until the end of treatment at 1:20 PM. There was no documentation in the medical record or on the hemodialysis flowsheets indicating the rationale for not adhering to the physician’s BFR order on 7/16/24 ,7/18/24 and 7/23/24. During interview on 8/9/24 at 9:46 AM, Staff (S) 3, Manager Clinical Services, confirmed the above findings and stated that the BFR was not at the prescribed rate on the above reviewed dates. During an interview at 10:46 AM, S4, the Clinical Coordinator, confirmed that Medical Record 4 lacked a documented rationale for why staff did not adhere to the prescribed BFR on the above dates. S4 stated that if the BFR cannot be met then the reason must be documented in the medical record. Review of facility policy titled, “Pre-Intra-Post Treatment Data Collection, Monitoring and Nursing Assessment,” revised April 2021, 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 ...”. N.J.A.C 8:43A-24.4(a)”

“QAPI-INDICATOR-PT SATIS & GRIEVANCES CFR(s): 494.110(a)(2)(viii) The program must include, but not be limited to, the following: (viii) Patient satisfaction and grievances. This Standard is not met as evidenced by: 37656 Based on a review of two (2) of two (2) facility complaints, a review of facility quality assurance performance improvement (QAPI) data, staff interview, and a review of the facility policy, it was determined that the facility failed to ensure that patient complaints and grievances are included in the QAPI program. Findings include: A review of the facility “Patient Grievance Log” revealed that complaints were received from patients on 1/24/24 and 1/31/24, with similar concerns regarding physician rounding. A review of the electronic QAPI data for the month of February to July 2024, lacked evidence that the patient complaints and grievance were tracked and trended for commonalities of issues. Upon interview on 8/9/24 at 1:00 PM, Staff (S) 2, Facility Administrator, stated that they discuss the grievances in their monthly meetings but it is not documented in QAPI data. A review of the facility policy titled, “Continuous Quality Improvement Program,” states, “... 2. Facility Administrators (FAs) conduct periodic Facility Health Meetings (FHM) (also known as QAPI [Quality Assessment and Performance Improvement]...) with the Continuous Quality Improvement (CQI) committee to review issues and indicators regarding facility’s management and performance. FHMs are conducted monthly. ...7. The facility will measure, analyze, and track quality indicators or other aspects of performance. The program must include, but not limited to, the following: ... patient Satisfaction and Grievances, ... 8. Continuous monitoring of the above indicators will be reflected in the meeting minutes. ...” N.J.A.C. 8:43A-24.18(c)”

“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: 38289 Based on observation, staff interviews, and a review of facility documents, it was determined that the Medical Director failed to ensure that pre-drawn heparin syringes are administered in accordance with facility policy and procedure for one of two observations of medication administration. Findings include: On 8/7/24 at 11:15 AM, Staff (S) 8, Registered Nurse was called to Station 5 by S10, Patient Care Technician, for the administration of the medication Heparin. S8 went to a cart located at the nurse’s station and unlocked the top drawer and removed two syringes of a clear liquid. S8 confirmed that the clear liquid was the medication, Heparin. The syringes were affixed together by a label that contained the name of the patient, the medication, dose, time and date the medication was drawn up, and the initials of the staff member that drew the medication up. S8 proceeded to walk over to administer the medication. Prior to entering Station 5, this surveyor inquired what time the medication was drawn up. S8 looked at the time and replied that the medication was drawn up at 9:45 AM, then proceeded to continue to the bedside of the patient at Station 5. Upon entering the Station, S8 looked at the syringes again and looked at the clock, and then stated, “Oh, I can’t use this now. I will have to redraw.” The time on the clock read 11:17 AM. S8 discarded the syringes and left the Station to redraw the medication in the Medication Prep room. During an interview at 11:19 AM with S8, he/she confirmed that there is an RN assigned to each side of the dialysis unit. Each RN is responsible for pre-drawing the medications for each patient prior to the start of each shift. The medications then get labeled and placed in the top drawer of the medication cart until it is ready to be used. S8 confirmed that the pre-drawn medications should be given within an hour. Review of facility policy titled, “Medication Policy,” revised October 2022, stated, “... 18. All syringes prepared from single use vials/ampules (without preservatives) or multidose vials should be prepared an administered within a four (4) hour [within one (1) hour for States of Florida, New Jersey and South Carolina] period ...” N.J.A.C. 8:43A-9.3(a)”