Davita Manahawkin

“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: 51227 Based on two of two observations of the cleaning and disinfection of a dialysis station, staff interview, and review of facility documents, it was determined that the facility failed to ensure that all surfaces, including the chaise wall and television, within the dialysis station are cleaned and disinfected after patient use to prevent cross contamination. Findings include: On 10/16/24 at 10:07 AM, Staff (S) 4, a Patient Care Technician (PCT), entered Station 4 and used a bleach-soaked cloth to clean the patient recliner chair, hemodialysis machine, and the blood pressure (BP) cuff. S4 did not clean the chaise wall and television located within Station 4. At 10:28 AM, S4, entered Station 1 and used a bleach-soaked cloth to clean the patient recliner chair, hemodialysis machine, and BP cuff. S4 did not clean the chaise wall and television located within Station 1. During an interview on 10/16/24 at 11:16 AM, S1, the Facility Administrator, stated per the facility’s policy, the chaise wall and television should be cleaned with a bleach soak cloth in between each patient. A review of the policy titled, “Infection Control For Dialysis Facilities,” revision date April 2023, stated, “ ... Disinfection: ... 13. At the end of each treatment, the dialysis station will be cleaned and disinfected. A: Surfaces to disinfect include but are not necessarily limited to: all surfaces in contact with the patient or their belongings (e.g., dialysis chair, tray tables, blood pressure cuffs) and frequently contacted by healthcare personnel (e.g., control panel; top, front and sides of dialysis machine; touchscreens; countertops). ...” N.J.A.C. 8:43A-24.8(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 one of one observation of the initiation of dialysis using a central venous catheter (CVC), staff interview, and review of facility documents, it was determined that the facility failed to implement infection control practices for cleansing the CVC access site and limbs prior to initiating hemodialysis. Findings include: On 10/16/24 at 11:29 AM, in Station 2, Staff (S) 3, a Registered Nurse (RN), was observed initiating hemodialysis through a CVC. S3 cleaned the CVC exit site for 13 seconds with a 2% Chlorhexidine Gluconate swab. This is 17 seconds less than required per facility policy. S3 then used one alcohol preparation (prep) pad to clean both limbs of the CVC with the same pad. S3 did not clean the exit site for 30 seconds and did not acquire a new alcohol prep pad when cleaning each limb of the CVC. During an interview on 10/16/24 at 12:35 PM, S3 explained that the procedure for cleaning the exit site and limbs is to clean the access site for thirty seconds and to clean the limbs with an alcohol prep pad. 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 the non- dominant hand and using aseptic technique, clean exit site with 2% Chlorhexidine Gluconate/70% Isopropyl Alcohol swab 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 ... “ N.J.A.C. 8:43A-24.8(b)”

“PE-ACCOMMODATE PT PRIVACY CFR(s): 494.60(c)(3) The dialysis facility must make accommodations to provide for patient privacy when patients are examined or treated and body exposure is required. This Standard is not met as evidenced by: 33556 Based on one of one observation and staff interview, it was determined that the facility failed to ensure that patient privacy is maintained at all times. Findings include: On 10/16/24 at 12:40 PM, during a review of the facility’s evacuation carts, located in front of a half wall that was behind Station 1 and Station 2, with Staff (S)1, the Facility Administrator, and S3, the Charge Nurse, a staff member was observed to close the privacy curtains on each side of a patient occupied in Station 1. There was no privacy curtain in the back of the station. This allowed this surveyor to see directly over the half wall and into the station. This finding was confirmed by S6, a Biomedical Technician, upon discovery. N.J.A.C. 8:43A-24.15(a)”

“PA-ASSESS CURRENT HEALTH STATUS/COMORBIDS CFR(s): 494.80(a)(1) The patient’s comprehensive assessment must include, but is not limited to, the following: (1) Evaluation of current health status and medical condition, including co-morbid conditions. This Standard is not met as evidenced by: 39228 Based on observations, staff interview, medical record review (Patient [P] 3), and review of facility documents, it was determined the facility medical director failed to ensure that the RN (Registered Nurse) documents a physical assessment of the patients lung sounds in four of nine treatments reviewed for P3. Findings include: A review of the “Treatment Details Reports” in P3’s medical record revealed the following: On 10/02/24, the “Treatment Nurse Assessment” section stated, “ ... Respiratory Observations Pre - Clear Post - Oxygen in Use: O2 [oxygen] L [liters]/min [minute]. The post treatment nursing assessment did not contain documentation by the RN of the auscultation (listening to the sounds of the body during physical examination) of P3’s lung sounds. On 10/04/24, the “History” section stated “Pre-Treatment - Respiratory ... Clear ...” and the “Treatment Nurse Assessment” section stated, “ ... Respiratory Observations Pre - Oxygen in Use: O2 L/min Post - N/A (not applicable).” The post treatment nursing assessment did not contain documentation by the RN of the auscultation of P3’s lung sounds. On 10/07/24, the “Treatment Nurse Assessment” section stated, “ ... Respiratory Observations Pre - Diminished (Lower Left); Diminished (Lower Right); Oxygen in Use: O2 L/min Post - Oxygen in Use: O2 L/min.” The post treatment nursing assessment did not contain documentation by the RN of the auscultation of P3’s lung sounds. On 10/09/24, the “Treatment Nurse Assessment” section stated, “ ... Respiratory Observations Pre - Diminished (Lower Right); Diminished (Upper Right); Oxygen in Use: O2 L/min Post - N/A.” The post treatment nursing assessment did not contain documentation of the auscultation of P3’s lung sounds. On 10/17/24 at 1:30 PM, the above findings were reviewed with Staff (S) 1, Facility Administrator, and S2, Manager of Clinical Services. S1 and S2 explained that the nurses conduct a post treatment assessment of the lung sounds, however, they are unsure why the documentation of the assessment is not reflected on the flowsheets. A review of facility policy titled, “Pre-Intra-Post Treatment Data Collection, Monitoring, and Nursing Assessment,” revised April 2024, stated, “... Policy: ... 2. The Nursing Assessment will be performed and documented by a licensed nurse; ... a. The assessment includes the following components: ... vi: A physical assessment of the patient which includes ... 2. Auscultation of the lungs ...” N.J.A.C. 8:43A-24.6(d)(3)”

“PA-APPROPRIATENESS OF DIALYSIS RX CFR(s): 494.80(a)(2) The patient’s comprehensive assessment must include, but is not limited to, the following: (2) Evaluation of the appropriateness of the dialysis prescription, This Standard is not met as evidenced by: 50912 Based on medical record review, staff interview, and review of facility policy and procedure, it was determined that the facility failed to ensure that staff followed the physician’s hemodialysis prescription orders for the dialysis machine temperature in four of 12 hemodialysis treatments reviewed. Findings include: On 10/17/24, a review of Patient (P) 2’s medical record revealed the following: The “Dialysis Prescription” portion of the “Treatment Details Report” section of the medical record stated, “... In-Center Hemodialysis treatment, three times a week [Monday, Wednesday, Friday], 3 hrs [hours] and ... Dialysate Temperature: 37.0 degrees C [Celsius]...”. A review of the hemodialysis treatment sheets from 09/16/24 to 10/11/24 indicated that the physician prescribed temperature was not followed on the following treatment dates: On 09/20/24, the machine temperature was documented as 38.0 degrees C. On 09/30//24, the machine temperature was documented as 38.0 degrees C. On 10/09//24, the machine temperature was documented as 38.0 degrees C. On 10/11/24, the machine temperature was documented as 38.0 degrees C. On 10/17/24 at 1:30 PM, the above findings were confirmed with Staff (S) 1, Facility Administrator. The medical record did not contain documented evidence that the physician was made aware of the changes in temperatures on the above dates. Facility policy titled, “Physician Order for Patient Care,” revised October 2024, stated, “... Purpose: To verify that orders are properly documented, transcribed, verified and implemented in a timely manner for patient care in DaVita facilities ... which meets all DaVita, federal and applicable state regulations ...”.”

“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: 39228 Based on medical record review, staff interview, and a review of facility documents, it was determined the facility failed to ensure that: 1) patients receive hemodialysis treatments at the prescribed BFR (blood flow rate) for three of the nine treatments reviewed for Patient (P) 3; and 2) patient treatments that are terminated early are documented per facility policy and the physician is notified for two of two treatments terminated early. Findings include: 1. A review of P3’s medical record revealed the following: A Plan of Care meeting with the interdisciplinary team for P3 occurred on 05/01/24. The “Orders” section dated 09/13/24, included a physician order for a BFR of “400 mL/min (milliliters/minute).” A review of hemodialysis treatment sheets, “Treatment Details Report,” from 09/16/24 to 10/11/24 indicated that the prescribed BFR was not followed on the following treatment dates: On 09/25/24, P3 was dialyzed with a BFR of 350 from the initiation of the treatment at 11:41 AM until the end of the treatment at 03:49 PM (four hours and eight minutes). On 10/04/24, P3 was dialyzed with a BFR of 350 from 12:02 PM until the end of the treatment at 03:32 PM (three hours and 30 minutes). On 10/09/24, P3 was dialyzed with a BFR of 350 from 11:58 AM until the end of the treatment at 03:24 PM (three hours and 22 minutes). The medical record lacked documented evidence of a rationale for a lower BFR rate of 350 instead of the prescribed BFR of 400 on the above dates. On 10/17/24 at 1:20 PM, the above findings were reviewed with Staff (S) 1, the Facility Administrator. S1 stated that staff members should write a comment about why they cannot achieve the prescribed BFR. A review of facility policy titled, “Pre-Intra-Post Treatment Data Collection, Monitoring, and Nursing Assessment,” revised April 2024, stated, “... Intradialytic Data Collection/Assessment ... 10. If the dialysis prescription is not being met (including ... change to/inability to obtain prescribed blood flow rate) the reason will be documented ...” 2. A review of P3’s medical record revealed the following: The “Orders” section stated, “In-Center Hemodialysis Treatment Start Date 09/13/2024 ... Frequency/TX [treatment] time Three times a week, 240 mins [minutes] ... “ On 10/02/24, the “Treatment Details Report” indicated that P3’s initiation of hemodialysis began at 06:42 AM and that treatment was terminated at 09:43 AM, 1 hour and 35 minutes earlier than the prescribed treatment time. The medical record lacked documented evidence that P1’s attending nephrologist was notified that the prescribed treatment time was not met. On 10/11/24, the “Treatment Details Report” indicated that P3’s initiation of hemodialysis began at 11:23 AM and that treatment was terminated at 01:47 PM, 1 hour and 2 minutes earlier than the prescribed treatment time. The medical record lacked documented evidence of a completed Early Termination of Treatment Against Medical Advice form and that P3’s attending nephrologist was notified that the prescribed treatment time was not met. On 10/17/24 at 01:20 PM, S1 confirmed that there was no physician notification documented by the RN for the above treatments and stated that the nurses should have written a note indicating that they notified the doctor that the treatment ended early. Upon request, S1 was unable to locate a signed Early Termination of Treatment Against Medical Advice form for the treatment dated 10/11/24. Review of 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. ... 4. A RN must countersign all ... forms. ... B. Prescribed Treatment Time Not Met 1. If shortened/early termination of treatment time exceeds 30 or more minutes, the 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-24.13(b)”

“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: 48966 Based on two of two observations of the initiation of hemodialysis through an arteriovenous graft/fistula (AVG/F), staff interview, and a review of facility documents, it was determined that the facility failed to ensure that staff perform skin disinfection of the access site prior to initiating the dialysis treatment in accordance with facility policy. Findings include: On 10/16/24 at 10:02 AM, Staff (S) 4, a Patient Care Technician (PCT), initiated dialysis through a patient’s AVG in Station 10. After cleansing each site of the AVG with alcohol pads in a circular motion, S6 applied betadine for 30 seconds in a circular motion to each site and allowed the betadine to dry for one minute and 25 seconds prior to cannulation (the action of inserting a metal tube into the body to draw fluid or introduce medication). The betadine dry time was 35 seconds less than required by facility policy. During an interview at 10:58 AM on 10/16/24, when asked about the dry time of the betadine, S4 stated, “... two minutes. Didn’t I do that? ...” 51227 At 10:45 AM, S3, a Registered Nurse (RN), was observed in Station 6 for the initiation of hemodialysis through an AVF. S3 cleansed the site of the AVF with an alcohol preparation (prep) pad in a circular motion, S3 then cleansed the first site of the AVF with povidone iodine in a circular motion for eight seconds. This was 22 seconds less than required by facility policy. S3 then proceeded to clean the second site with povidone iodine in a circular motion for six seconds, this is 24 seconds less than required by facility policy. During an interview at 12:35 PM, S3 was asked about the procedure for performing skin disinfection of the AVF access site. S3 explained that the procedure should be to clean the sites with an alcohol prep pad for 30 seconds, then clean the site with iodine for 15 seconds, and have a dry time of 2 minutes after the iodine. A review of the 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 Povidone Iodine ... Effective Volume At least 1 prep pad per site or 1 saturated sterile gauze pad per site ... Effective Contact Time 30 seconds ... Air Drying Time 2 minutes ... 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) ...” 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: 48966 Based on one of one observation of chlorine (bleach) solution bottles, staff interview, and review of facility documents, it was determined the Medical Director failed to ensure that staff adhere to the policy and procedure for labeling of chlorine (bleach) solution for disinfecting. Findings include: On 10/16/24 at 9:46 AM, the following was observed during a tour of the Hemodialysis Treatment Area: A white bottle with a yellow goose neck top was present on the countertop next to Clean Sink 6 across from Station 7. The bottle was labeled 1:10 bleach solution with a date of 10/15/24. The labeled 1:10 bleach solution bottle lacked the preparation time and the initials of the person who prepared it, to ensure the bleach solution did not exceed the 24 hour maximum allowable usage time to be used. During an interview at 9:54 AM, Staff (S) 3, the Charge Nurse, confirmed the bottle of 1:10 bleach solution was used to clean blood spills. S3 verified that the 1:10 bleach solution had not been changed that day, 10/16/24. S3 explained the Patient Care Technicians (PCTs) are responsible for changing the bleach solutions daily. At 10:19 AM, S5, a Registered Nurse (RN), was observed placing the 1:10 bleach bottle dated 10/15/24 on the countertop at Clean Sink 6. During an interview at 10:20 AM, S5 explained he/she used the 1:10 bleach solution to clean a small blood splatter at Station 6. When questioned, S5 acknowledged the bottle had expired and explained the bleach solution should be changed every morning by the PCT. A review of the facility policy and procedure titled, “Preparation Of One To Ten (1:10) Bleach Solution,” revised in October 2023, states, “... Procedure ... 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(b)”