Davita Perth Amboy Dialysis

“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: 51227 Based on one of one observation of the initiation of hemodialysis through a central venous catheter (CVC)(a type of access used for hemodialysis), staff interview, and a review of facility policy, it was determined that the facility failed to ensure the staff perform hand hygiene in accordance with facility policy. Findings include: On 11/12/24 at 10:35 AM, in Station 10, Staff (S) 7, a Registered Nurse (RN) was observed initiating hemodialysis through a CVC. After cleaning the exit site, catheter limbs, and the catheter end caps, S7 proceeded to place a new dressing over the exit site. S7 did not remove his/her gloves, perform hand hygiene, and don (put on) a new pair of gloves before applying the new dressing as per facility policy. S7, with the same gloves on, proceeded to scrub each CVC hub and attach a sterile 10 milliliter (ml) syringe to each of the limbs. S7 did not remove his /her gloves and perform hand hygiene after applying a new dressing, and before proceeding to the next step of scrubbing of the catheter hub per facility policy. During an interview at 10:45 AM, S7 was asked about the use of gloves, performing hand hygiene and donning new gloves during the CVC cleaning procedure. S7 stated, he/she only needs to remove gloves and perform hand hygiene after the removal of the dirty dressing and if he/she touches the dialysis machine. A review of the facility policy titled, “Central Venous Catheter (CVC) with Clearguard HD Antimicrobial End Caps Procedure,” revised October 2024, stated, “... Procedure: ... 9. Clean each CVC limb/cap with a new LARGE alcohol prep pad, starting close to the exit site and finishing with the cap. 10. Remove gloves and discard, perform hand hygiene per procedure and re-glove... 12. Place sterile 2x2 [2 inch by 2 inch] gauze over the catheter exit site leaving connections accessible. Minimize contact with the 2x2 gauze by holding only a corner. Seal edges of gauze with tape; limiting the amount of tape on the limbs ... 14. Remove gloves and discard, perform hand hygiene per procedure and re-glove ... 16. Verify both catheter clamps are closed. 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, for example blood. Hold the limbs until the antiseptic has dried ...’’ N.J.A.C. 8:43A-24.8(b)”

“IC-SINKS AVAILABLE CFR(s): 494.30(a)(1)(i) A sufficient number of sinks with warm water and soap should be available to facilitate hand washing. This Standard is not met as evidenced by: 37656 Based on observation, staff interviews, and a review of facility policy, it was determined that the facility failed to ensure that the staff and patients use clean sinks dedicated to hand washing. Findings include: On 11/12/24 at 10:48 AM, a patient entered the Isolation Room (Station 15). Staff (S) 6, the Patient Care Technician (PCT), instructed the patient to wash his/her hands and pointed to the dirty sink. S5, the Clinical Coordinator saw the patient washing his/her hands at the dirty sink and told S6 to let the patient wash his/her hands in the clean sink. S6 told the patient to wash his/her hands again at the clean sink. Upon interview at 11:10 AM, S6 stated that he/she made a mistake of directing the patient to wash his/her hands at the dirty sink and it should always be the clean sink. Reference: Facility policy titled, “Infection Control for Dialysis Facilities,” revised April 2023, stated, “... FACILITY HYGIENE ... 19. ... Clean sinks should be easily accessible in the treatment area and in other appropriate areas such as ... isolation room. ...” N.J.A.C 8:43A-24.4(b)”

“IC-HBV-ISOLATION-MACHINES/EQUIP/SUPPLIES CFR(s): 494.30(a)(1)(i) Isolation of HBV+ Patients To isolate HBsAg positive patients, ... dedicate machines, equipment, instruments, supplies, and medications that will not be used by HBV susceptible patients. This Standard is not met as evidenced by: 37656 Based on one of one observation of the Hepatitis B Isolation Room, staff interview, and facility policy review, it was determined the facility failed to ensure all supplies in the Isolation Room are labeled for “isolation.” Findings include: During the entrance conference on 11/12/24, Staff (S) 1, Facility Administrator, stated that they have three Hepatitis B surface Antigen positive (HBsAg +) patients dialyzing in the Isolation Room (Station 15). At 10:30 AM, during tour of the Isolation Room, the following was observed: the dialysis chair was not labeled as dedicated to the Isolation Room and there was no glucometer in the room. Upon interview at 10:35 AM, S5, Clinical Coordinator, stated that the chair locks are in red and it indicates the chair was for the Isolation Room only. When asked what their policy was, S5 stated that they should be labeled with the word “isolation.” At the time of interview, S5 took a permanent marker and wrote the word “isolation” on the top portion of the chair. S5 also stated that he/she did not know what happened to the glucometer in there and will get a new one. A review of the facility policy titled, “Hepatitis B Surveillance, Vaccination, Infection Control Measures and Isolation Guidance,” revised April 2024, stated, “... INFECTION CONTROL MEASURES FOR CONFIRMED POSITIVE OR SUSPECTED/UNKNOWN STATUS 17. PPE a. When entering the isolation room/area or station for any reason, physicians, NPPS, Social Workers, dietitians and all other teammates will wear long-sleeved fluid resistant/fluid impervious gowns in addition to gloves, face shield, or mask and eye protection. b. The long-sleeved gown will be tied in the back and gloves will be pulled over the cuffs of the sleeves. ... 19. EQUIPMENT/SUPPLIES ... a. Dedicated ancillary supplies such as blood pressure cuffs, clamps, tourniquets, stethoscope, blood glucose meter ... and nondisposable items. ... b. Such supplies will be labeled “isolation” and will remain in the isolation room/area or station and be disinfected after every patient use with a 1:100 (one to one hundred) bleach solution ...” N.J.A.C 8:43A-24.4(b)”

“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: 51227 Based on observation, staff interviews, and a review of facility policy, it was determined that the facility failed to ensure that: 1) infection control practices for cleaning the central venous catheter (CVC)(a type of access used for hemodialysis) exit site and limbs prior to initiating hemodialysis using a CVC in one of one observation is implemented; 2) the patient uses a surgical face mask covering the nose and the mouth when discontinuing hemodialysis to decrease the risk for infection in one of three observations. Findings include: 1. On 11/12/24 at 10:35 AM, in Station 10, Staff (S) 7, a Registered Nurse (RN), was observed initiating hemodialysis through a CVC. S7 cleaned the CVC exit site using a 2% Chlorhexidine Gluconate prepackaged swab for eight seconds, this was 22 seconds less than indicated by facility policy. S7 then used one alcohol preparation (prep) pad to clean both limbs of the CVC. S7 did not obtain a new alcohol prep pad when cleaning each limb of the CVC. During an interview at 10:45 AM, S7 explained the procedure for cleaning of the exit site and limbs. He/she stated the procedure is to clean the exit site for 28-30 seconds with the chlorhexidine swab and then clean the limbs with a alcohol prep pad for 15 seconds. A review of the facility policy titled, “Central Venous Catheter (CVC) with Clearguard HD Antimicrobial End Caps Procedure,” revised October 2024, stated, “... Procedure: ... 8. Holding catheter with non-dominant hand and using aseptic technique, clean exit site with 2% Chlorhexidine Gluconate/70 % Isopropyl Alcohol swap for a minimum of 30 seconds ... 9. Clean each CVC limb/cap with a new LARGE alcohol prep pad, starting close to the exit site and finishing with the cap ...” 50912 2. During observation on the Treatment Floor on 11/12/24 at 1:20 PM, S7, a Registered Nurse, was observed during discontinuation of Patient (P) 8’s hemodialysis treatment via a CVC access site located on the right upper chest wall. It was observed that P8 had a face mask that was not covering his/her nose and mouth throughout the duration of the discontinuation of hemodialysis via the CVC. At 1:25 PM, this finding was confirmed with S7. S7 immediately asked P8 to pull up the mask to cover his/her nose and mouth. Upon interview at 1:28 PM, S7 stated, “The patient should have worn the mask while the CVC care is going on.” Upon an interview at 1:31 PM, with S5, Clinical Coordinator confirmed that P8 should have his face mask on during the entire duration of CVC care. Upon review of S7’s education and training, he/she received a certificate of completion of the “New Jersey State Specific Education” dated 2/27/24, that included training on “Access Care and Management.” A review of facility policy titled, “Central Venous Catheter (CVC) With Clearguard HD Antimicrobial End Caps Procedure,” revised 10/24, stated,”... Procedure 26 ...Upon Completion of Dialysis ... Put on PPE (Personal Protective Equipment) and provide a mask to the patient. Teammate and patient will wear mask covering the nose and mouth during this procedure ...” N.J.A.C. 8:43A-24.8(b)”

“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: 37656 Based on observation, staff interviews, and a review of facility policy, it was determined that the facility failed to ensure the water treatment room door is kept locked at all times. Findings include: On 11/12/24 at 9:43 AM, the six surveyors entered the facility and observed that the door to the water treatment room was propped open with a door stopper. There was no one in the Water Room. Upon interview at the time of discovery, Staff (S) 1, the Facility Administrator, stated he/she did not know why the door was kept open. S1 closed the door at the time of interview. Upon interview on 11/12/24 at 11:15 AM, S8, Biomedical Technician, he/she stated that the Water Treatment Room should be locked at all times. S8 stated that only the authorized clinical staff were allowed to have access to the Water Room and it should be kept locked at all times. A review of the facility policy titled, “Water Treatment Systems Minimum Component Requirement,” revised October 2021, stated, “... 2. ... 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: 51040 Based on observation and staff interview on 11/12/24, it was determined that the facility failed to ensure the dialysis facility is maintained to ensure the safety of the patients. Findings include: During a tour of the facility, in the presence of Staff (S) 8, the Biomedical Technician, the following was observed: At 10:25 AM, the louvers on the ceiling heating and air conditioning vents in the Unisex Staff Bathroom, Conference Room, back hall near breaker panels, Infectious Waste Room, and Housekeeping Closet were covered with dust. At 10:32 AM, the chase wall under water box was delaminating exposing the porous, uncleanable surface between patient Stations 3 and 4. At 10:37 AM, the dirty sink across from Station 13 has an unknown residue buildup on top of the sink counter. At 10:47 AM, the paper towel dispenser located in the Staff Unisex Bathroom in the back hallway was coming off the wall. At 10:49 AM, the shelf located in the Housekeeping Closet had a reddish-brown residue. At 10:50 AM, the wall in the Conference Room was damaged, exposing porous gypsum board, approximately two (2) linear feet behind the chairs, which cannot be properly cleaned. N.J.A.C. 8:43A-17.3(a) N.J.A.C. 8:43A-17.3(e) 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: 48966 Based on one of one observation of Embrace Pro test strips (strips use in blood glucose meters for testing blood sugar), staff interviews and review of manufacturers instructions for use (MIFU), it was determined the facility failed to ensure the Embrace Pro test strips are maintained in accordance with the MIFU. Findings include: During a tour of the Dialysis Unit on 11/12/24 at 11:03 AM, in the “Soiled Utility/Lab” room, a small white plastic container holding the glucometer, testing solutions, and “Embrace Pro” test strips were found on the countertop. The “Embrace Pro” test strips lacked a label with the date the glucose test strip bottle was opened. During an interview on 11/12/24 at 11:07 AM, Staff (S) 5, Clinical Coordinator, confirmed the “Embrace Pro” test strips should be labeled upon opening but was unsure of the shelf life. S5 explained he/she would verify with the Manager of Clinical Services on how long the test strips are good for once opened. S5 discarded the bottle of undated opened “Embrace Pro” test strips. During an interview on 11/12/24 at 11:19 AM, S9, Manager of Clinical Services (MCS), confirmed the “Embrace Pro” test strips must be labeled when opened and are valid for four months. A review of the manufacturer’s instructions of Embrace Pro Test Strips, stated, “... Storage and Handling ... Use all the strips within 4 months after the first opening ...” N.J.A.C. 8:43A-24.4(a)”

“PR-PRIVACY & CONFIDENTIALITY-TREATMENT CFR(s): 494.70(a)(3) The patient has the right to- (3) Privacy and confidentiality in all aspects of treatment; This Standard is not met as evidenced by: 50912 Based on one of two observations of discontinuation of dialysis via a central venous catheter (CVC)(a type of access used for hemodialysis), review of facility policy, and staff interview, it was determined that the facility failed to ensure each patient’s right to privacy during a procedure that exposes a body part during dialysis. Findings include: On 11/12/24 at 1:20 PM, during observation on the Treatment Floor, Staff (S) 7, a Registered Nurse, entered Station 9 and pulled the privacy curtains located on each side of the station to ensure patient privacy on the left and right side of the patient. S7 did not pull a privacy curtain in front of Station 9 which allowed for staff, and patients in Stations 18, 17, and 16 on the treatment floor to have a direct view of P8’s care. S7 then proceeded to perform discontinuation care of P8’s hemodialysis treatment via a right upper chest wall CVC access site. The privacy curtain in front of the station was not pulled fully closed throughout the duration of the discontinuation of hemodialysis via the CVC. Upon interview at 1:28 PM, this finding was confirmed with S7, who stated “Oh, I forgot to close the front curtains.” Upon review of S7’s education and training, he/she received a certificate of completion of the “New Jersey State Specific Education” dated 2/27/24, that included training on “Access Care and Management.” During an interview on 11/12/24 at 1:31 PM, Staff (S) 5, the Clinical Coordinator, confirmed that all the privacy curtains located in the station should be fully closed during CVC care. Review of facility policy titled, “Patient Rights,” last revised October 2021, stated, “Your Rights As A Patient: ... 4. The right to privacy and confidentiality in all aspects of treatment. The dialysis facility will make accommodations for ...privacy when patients are examined or body exposure ...with privacy screens or curtains ...” N.J.A.C. 8:43A-16.2(a)10”

“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: 37656 Based on observation, staff interview, and review of facility procedures, it was determined the facility failed to ensure that staff perform proper skin disinfection of the access site prior to initiating dialysis treatment in one of one observation of the initiation of dialysis through an Arteriovenous Fistula/Graft (AVF/G) access. Findings include: On 11/12/24 at 10:55 AM, Staff (S) 6, a Patient Care Technician, was observed during initiation of dialysis through Arteriovenous Fistula/Graft (AVF/G) on the patient at Station 15 (Isolation Room). S6 used three alcohol swabs for 10 seconds each to clean the arterial and venous sites, then used a betadine swab to swab the sites for five seconds. Without allowing it to air dry, immediately cannulated the sites. This was not in accordance with facility procedure. Upon interview at 11:10 AM, S6 stated that they have to wait for two minutes to allow the betadine to air dry. S6 confirmed he/she did not wait for two minutes. On 11/14/24, S6 personnel file was reviewed and revealed that S6 received education on AVF/AVG Cannulation on 2/2/24, which includes the policy and procedure to properly prepare cannulation sites per policy and procedure. Review of facility procedure 1-04-01E, 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 ... Povidone Iodine ... Effective contact Time ... 30 seconds ... Air drying time ... 2 minutes ... Skin Antiseptic ... Isopropyl Alcohol 70% ... 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 center out and allow to dry. ...” N.J.A.C. 8:43A-24.8(b)”

“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: 50912 Based on two of seven medical record reviews (Patient (P) 1 and P2), staff interviews, and review of facility documents, it was determined that the facility failed to ensure that monthly progress notes are completed by the physician. Findings include: A review of P1’s medical record lacked documented evidence of a physician’s monthly progress note for May and August 2024. A review of P2’s medical record lacked documented evidence of a physician’s monthly progress note for August 2024. Staff (S) 9, the Manager of Clinical Services, was unable to find documented evidence of a physician monthly progress notes by Staff (S) 12, a Physician, for the above-mentioned months. During an interview on 11/13/24 at 1:30 PM S9 stated, “This has been an issue with this doctor [S12] before. He/she has been spoken to by the Medical Director and facility leadership to be more engaged in seeing patients and in documenting his/her monthly progress notes.” A review of facility policy titled, “Progress Note Policy,” revision date of 10/24, stated, “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 observations, staff interviews, and review of facility documents, it was determined the facility Medical Director failed to implement the facility policy to ensure that open acid jugs are properly labeled and stored for two of two opened acid jugs observed. Findings include: On 11/12/24 at 10:05 AM, during tour of the Dialysis Treatment Floor, an opened jug, approximately two third (2/3) full of Naturalyte 1.0 K (Potassium), 2.5 Ca (Calcium) acid solution, was stored at the Nurse’s Station with 26 additional unopened acid jugs. The container was not labeled with a date of opening and was available for use. Upon interview at the time of discovery, Staff (S) 5, Clinical Coordinator, stated that he/she did not know why it was there and did not know when it was opened. S1, Facility Administrator then removed the jug and stated he/she will neutralize it with bicarbonate and discard. At 10:10 AM, an opened jug, approximately one third (1/3) full of Naturalyte 1.0 K, 2.5 Ca acid solution, was stored at Clean Sink 8 across from Station 3. The container was not labeled with a date of opening and was available for use. Upon interview at 10:15 AM, Staff (S) 3, Registered Nurse, moved the acid jug to the dirty sink counter across from Station 2. S3 stated that he/she will neutralize the acid with bicarbonate and discard later. S5 removed the jug from the dirty sink. A review of the facility policy titled, “Acid Concentrate System, Incoming Acid Concentrate and Use of Acid Concentrate Containers,” revision date October 2024, stated, “... ACID CONCENTRATE CONTAINERS ... 19. Acid concentrate is to be stored at room temperature in a secure designated area. 20. Upon opening an acid concentrate container, label container with date opened, and initials of the teammate. ...” N.J.A.C. 8:43A-24.4(a)”