Davita Millville Dialysis

“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: 50912 Based on one of three observations of the hemodialysis station, staff interview, and review of facility policy, it was determined that the facility failed to provide and maintain a sanitary environment to minimize the transmission of infectious agents within and between the hemodialysis stations. Findings include: On 11/20/24 at 12:02 PM, during an observation of the treatment floor, Staff (S) 5, a Registered Nurse, entered Station 1 to start the Central Venous Catheter (CVC) (a type of access used for hemodialysis) exit site care on Patient (P)10, who was in a patient bed. S5 pulled the privacy curtain closed between Station 1 and Station 2. The privacy curtain on Station 1 had multiple splattered reddish brown stained areas scattered throughout in the center area of the curtain, adjacent to the foot section of the patient bed. The largest was approximately 1 inch in diameter. Upon interview at 12:05 PM, S5 confirmed that the privacy curtain between Stations 1 and 2 had visible stained areas present. S2 stated, “We check the privacy curtains routinely, how could I have missed that? We will have it changed immediately.” During an interview at 1:38 PM, S1, the Facility Manager, stated that if something is observed in the privacy curtains that needs attention, then staff should report it to him/her, and a contracted housekeeping vendor would be called to address the issue. The housekeeping vendor is responsible for changing the soiled curtains. Facility policy titled, “Infection Control for Dialysis Facilities,” revised October 2022, stated, “... 45 Cleaning and/or disinfection of equipment or work surfaces will be performed as soon as possible following exposure to blood or other potentially infectious materials ... 69 After each treatment the floor area around chair/bed ... will be evaluated and cleaned if necessary ... 81 Any areas contaminated with visible blood or body fluids are cleaned promptly ... with bleach solution ...” N.J.A.C. 8:43A-24.4(b)”

“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 two observations of the initiation of hemodialysis through a central venous catheter (CVC)(a type of access used for hemodialysis), staff interview, and review of facility policies and procedures, it was determined that the facility failed to ensure that staff perform hand hygiene to prevent possible cross contamination. Findings included: On 11/20/24 at 11:50 AM, in Station 10, Staff (S6), a Registered Nurse (RN) initiated hemodialysis through a CVC. After cleaning the CVC exit site, catheter limbs, and the catheter end caps, S6 placed a new dressing over the exit site. S6 did not remove his/her gloves, perform hand hygiene, and don (put on) a new pair of gloves after cleansing the CVC and before applying the new dressing as per facility policy. After securing the new dressing, S6 placed a Vacutainer holder (a device used to collect blood samples) on the red limb, attached a blood collection tube, and drew blood from the CVC. During this process a small amount of blood transferred onto S6’s glove. S6 scrubbed the blue hub and attached the patient to the hemodialysis machine without the benefit of changing the visibly soiled glove and performing hand hygiene first. During an interview at 11:25 AM, S6 explained that there are three times during the CVC process where gloves are changed and hand hygiene is performed. Those times are after taking off the old dressing, after putting on a new dressing, and when done with the initiation of hemodialysis treatment. Facility procedure titled, “Central Venous Catheter (CVC) with Clearguard HD Antimicrobial End Caps,” revised October 2024, stated, “... 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. ... 11. Apply antibiotic ointment to exit site, if prescribed. ... 12. Place sterile 2x2 [2 inch by 2 inch] gauze over the catheter exit site leaving connections accessible. ...” Facility policy titled, “Infection Control For Dialysis Facilities,” last revised October 2022, stated, “... TEAMMATE HYGIENE: 1. Hand hygiene is to be performed upon entering the patient treatment area, prior to gloving, after removal of gloves, after contamination with blood or other infectious material, after patient and dialysis delivery system contact, between patients even if the contact is casual, before touching clean areas such as supplies and on exiting the patient treatment area. Physicians, Non-Physician Practitioners (NPP), and all teammates are to follow these same requirements for glove use and hand hygiene ... TEAMMATE/PATIENT SAFETY: ... 13. Gloves should be changed when: When soiled with blood, dialysate or other body fluids. When going from a “dirty” area or task to a “clean” area or task. When moving from a contaminated body site to a clean body site of the same patient ...” 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 two observations of the initiation of hemodialysis through a Central Venous Catheter (CVC) (a type of access used for hemodialysis), staff interview, and review of facility policy, it was determined that the facility failed to ensure that staff maintain aseptic technique during CVC care to prevent possible cross contamination. Findings include: On 11/20/24 at 11:50 AM, Staff (S) 6, a Registered Nurse, initiated hemodialysis through a CVC in Station 10. During the procedure the following was observed: S6 removed the red cap from the catheter hub, wiped the end with an alcohol swab, and connected an empty syringe to the catheter hub. S6 then aspirated approximately five milliliters (ml) of blood into the syringe, removed it from the catheter, and placed it onto the clean disposable pad, next to the pile of clean gloves. S6 then connected a Vacutainer holder (used for blood collection) and filled three blood tubes. Following the blood collection, S6 placed the blood tubes and Vacutainer holder onto the disposable pad, next to a pile of clean gloves. The placement of dirty supplies onto the surface containing clean supplies does not follow the procedure for aseptically discarding syringes. S6 then repeated the process described above with the blue capped hub and placed the used supplies, including a syringe filled with approximately 5 ml of blood and Vacutainer holder with visible blood on the tip, onto the chairside table, next to a pile of clean gloves. This was not in accordance with facility policy. S6 connected the patient to the hemodialysis machine and attempted to begin the treatment. The hemodialysis machine then alarmed. S6 disconnected the bloodline attached to the blue hub and the red hubs. S6 then reconnected the blue bloodline to the red hub and the red bloodline to the blue hub. Treatment was then initiated. S6 did not perform a 15 second hub scrub after disconnecting the bloodlines and prior to reattaching the bloodlines. This was not in accordance with facility policy which required the hubs to be scrubbed during a line reversal. Facility policy titled, “Central Venous Catheter (CVC) with Clearguard HD Antimicrobial End Caps Procedure,” last revised October 2024, stated, “ ... Perform 15 second hub scrub of the CVC during the process of connecting or disconnecting from the blood lines, including line reversal ... Aseptically discard syringe containing indwelling solution from arterial limb and attach a saline filled syringe. Repeat step for venous limb ...” N.J.A.C. 8:43A-24.8(b)”

“CARBON ADSORP-MONITOR, TEST FREQUENCY CFR(s): 494.40(a) 6.2.5 Carbon adsorption: monitoring, testing freq Testing for free chlorine, chloramine, or total chlorine should be performed at the beginning of each treatment day prior to patients initiating treatment and again prior to the beginning of each patient shift. If there are no set patient shifts, testing should be performed approximately every 4 hours. Results of monitoring of free chlorine, chloramine, or total chlorine should be recorded in a log sheet. Testing for free chlorine, chloramine, or total chlorine can be accomplished using the N.N-diethyl-p-phenylene-diamine (DPD) based test kits or dip-and-read test strips. On-line monitors can be used to measure chloramine concentrations. Whichever test system is used, it must have sufficient sensitivity and specificity to resolve the maximum levels described in [AAMI] 4.1.1 (Table 1) [which is a maximum level of 0.1 mg/L]. Samples should be drawn when the system has been operating for at least 15 minutes. The analysis should be performed on-site, since chloramine levels will decrease if the sample is not assayed promptly. This Standard is not met as evidenced by: 48966 Based on one of one observation of total chlorine testing, staff interviews, and review of manufacturer’s instructions for use (MIFU), it was determined that the facility failed to ensure chlorine testing is performed in accordance with the MIFU. Findings include: During an observation of total chlorine testing on 11/20/24 at 11:12 AM, Staff (S) 3, a Patient Care Technician (PCT), obtained a sample cup of water and, after filling and dumping the cup with water three times, dipped a RPC E-Z Chek Sensitive Total Chlorine Test Strip (strip use for detecting the chlorine level) into the water sample and gently moved the strip back and forth. After the one minute, S3 removed the RPC test strip and waited five seconds before comparing the test strip to the color chart. This was not in accordance with the MIFU. During an interview at 11:18 AM, S3 explained that the RPC E-Z Test Strip color is read after five seconds. During an interview at 11:30 AM, S2, the Biomedical Technician, confirmed the RPC E-Z Test Strip is to be read after waiting 20 seconds and then compare the test strip to the color chart. S3’s personnel file was reviewed and indicated that the procedural quality water treatment checklist which included total chlorine testing using RPC ultra-low test strips was completed on 3/7/24. A review of the RPC E-Z Chek Sensitive Total Chlorine Test Strip instructions for use stated, “... Test Procedure ... 4) Wait 20 seconds for the test strip to develop. ... 5) After the 20 second wait period, immediately compare the strip color to the K100-0118 or K100-0118F color chart to determine the Total Chlorine level in the sample. ...” N.J.A.C. 8:43A-24.10(a)(3)”

“DIST SYS-CULTURE/LAL/SITES/FREQ(NEW)/LOG CFR(s): 494.40(a) 6.3.3 Water distribution systems: culture/LAL sample sites/frequency (new)/log Water distribution piping systems should be monitored for bacteria and endotoxin levels. Bacteria and endotoxins shall not exceed the levels specified in [AAMI] 4.1.2. [(i.e., bacteria <200 CFU/mL and endotoxin <2 EU/mL] Bacteria and endotoxin testing should be conducted at least monthly. For a newly-installed water distribution piping system, or when a change has been made to an existing system, it is recommended that weekly testing be conducted for 1 month to verify that bacteria or endotoxin levels are consistently within the allowed limits. Monitoring should be accomplished by taking samples from the first and last outlets of the water distribution loop and the outlets supplying reuse equipment and bicarbonate concentrate mixing tanks. If the results of this testing are unsatisfactory, additional testing (e.g., ultrafilter inlet and outlet, RO product water, and storage tank outlet) should be undertaken as a troubleshooting strategy to identify the source of contamination, after which appropriate corrective actions can be taken. Bacteria and endotoxin levels shall be measured as specified in ANSI/AAMI RD62:2001 (see 2.3). All bacteria and endotoxin results should be recorded on a log sheet to identify trends that may indicate the need for corrective action. This Standard is not met as evidenced by: 48966 Based on a review of facility documents and staff interviews, it was determined that the facility failed to ensure that microbiological testing of the Reverse Osmosis (RO) machine and water distribution system are completed monthly for one of six months reviewed. Findings include: The “Water Treatment: Endotoxin/Culture Sampling Schedule” for the RO and water distribution system, and the test results were provided for review for May 2024 through October 2024. The following information was revealed: For the month of October 2024, the RO first out and RO last out, and Acid water out and Bicarbonate water out were to be completed for microbiological testing according to the “Water Treatment: Endotoxin/Culture Sampling Schedule.” There were no documented results of the microbiological tests drawn on 10/3/24. During an interview on 11/21/24 at 9:55 AM, Staff (S) 2, the Biomedical Technician, showed this surveyor the manifest date of 10/3/24, when the water samples were sent to the lab (laboratory), but the lab had canceled the tests. When asked about checking for results, S2 stated, “I usually check for results after four days.” S2 explained that he/she failed to notice the water samples were not processed by the lab. S2 stated, he/she “was occupied with the validation of the new hemodialysis machines and it fell through the cracks.” Facility policy titled, “Water Culture Policy,” revised April 2024 stated, “... Policy: ... 5. Monthly sample sites include: [bullet] Beginning of piping system, i.e., the first outlet downstream of the last purification component; if outlet not available, the first point of use: First Water Outlet- First H2O Out [bullet] Water supply to bicarb [bicarbonate] mixer, central bicarb system or water supply line utilized for preparing individual bicarb containers, as applicable: Bicarb Water Outlet-Bicarb H20 Out [bullet] Water supply to the acid concentrate mixing equipment, if present: Dry Acid Water Outlet- Dry Acid H2O Out [bullet] End of the piping system, i.e., last outlet on the piping system: Last Water Outlet- Last H2O Out ...” Facility policy titled, “Water Endotoxin Testing Policy,” revised April 2024 stated, “... Policy: ... 5. Monthly sample sites include: [bullet] Beginning of piping system, i.e., the first outlet downstream of the last purification component; if outlet not available, the first point of use: First Water Outlet- First H2O Out [bullet] Water supply to bicarb {bicarbonate] mixer, central bicarb system or water supply line utilized for preparing individual bicarb containers, as applicable: Bicarb Water Outlet-Bicarb H2O Out [bullet] Water supply to the acid concentrate mixing equipment, if present: Dry Acid Water Outlet- Dry Acid H2O Out [bullet] End of the piping system, i.e., last outlet on the piping system: Last Water Outlet- Last H2O Out ...” N.J.A.C. 8:43A-24.10(a)(2)”

“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: 51040 Based on observation and staff interview on 11/20/24, it was determined that the facility failed to ensure the dialysis facility is maintained to ensure safety of the patients. Findings include: A tour of the facility was conducted starting at 10:00 AM and the following was revealed: The area under the ‘clean sink’ located across from Station 16 contained a dirty bucket with old rags stored under the sink and the shelf surface that had spill stains. The area under the ‘dirty sink’ located across from Station 3 was dirty and stained with prior leaks from the piping. The area under the ‘dirty sink’ located across from Station 13 contained a drain piping that was leaking. A pipe chase located behind Station 7 had residue build up from a leak. Beside the patient floor scale, damage was noted to the wall corner, measuring approximately 8 inches in vertical length. The damaged area was an uncleanable surface. N.J.A.C 8:43A-17.4(13)”

“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: 49828 Based on one of two Central Venous Catheter (CVC) (a type of access used for hemodialysis) observations, and staff interview, it was determined that the facility failed to ensure each patient’s right to privacy. Findings include: On 11/20/24 at 11:12 AM, an initiation of dialysis via a CVC was performed by staff in Station 4. The curtains were drawn on both sides of Station 4, fully extending to ensure patient privacy on the left and right side of the patient. However, the curtain did not fully extend in the front of the station, leaving a two-foot opening. From the nurse’s station, patient occupied Station 15, and the Isolation Station, the patient’s exposed chest was visible. During an interview at 11:15 AM, Staff (S) 10, a Facility Administrator (FA) from another clinic, confirmed the above findings. S10 stated, the curtain needs to be longer. N.J.A.C. 8:43A-24.15(a)”

“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: 49828 Based on two of two observations of initiation of hemodialysis through an arteriovenous fistula/graft (AVF/G) (a connection that is made between an artery and a vein for dialysis access), staff interview, and a review of facility documentation, it was determined that the facility failed to ensure that skin is disinfected prior to cannulation of the access site. Findings include: On 11/20/24 at 10:29 AM, Staff (S) 7, a Patient Care Technician (PCT), washed his/her hands, donned (put on) gloves, and entered Station 7. S7 cleansed the AVF/G access site with an alcohol preparation (prep) pad in a circular motion for 31 seconds. This was 29 seconds less than required by facility policy. S7 then inserted a needle into the patient’s AVF/G. On 11/20/24 at 10:54 AM, S4, a Patient Care Technician (PCT), washed his/her hands, donned gloves, and entered Station 9. S4 cleansed the site of the AVF/G with ExSept in a circular motion for 39 seconds. This was 21 seconds less than required by policy. S4 then cleansed the site with povidone iodine in a circular motion for 17 seconds. This was 13 seconds less than required per the facility policy. S4 then inserted a needle into the patient’s AVF/G. During an interview at 11:05 AM, S4 stated that according to the facility’s policy, the staff should clean with “ExSept for 15-30 seconds, and Iodine for 15 seconds.” 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 Contact Time ... 30 seconds ... Hypochlorite (ExSept Plus) ... Effective Contact Time ... 60 seconds ... Isopropyl Alcohol 70% ... Effective Contact time ... 60 seconds ...” N.J.A.C. 8:43A-24.4(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 six of seven medical records reviewed, staff interviews, and review of facility documents, it was determined that the facility failed to ensure: 1) patients are assessed for post (after)-treatment pain; and 2) expired supplies are not made available for use. Findings include: 1. A review of Patient (P)4’s “Treatment Nurse Assessment,” on the “Treatment Details Report” dated 10/29/24 through 11/18/24, revealed the following: The post-treatment pain assessment was documented as “N/A [not applicable]” on the following treatment dates: 10/30/24, 11/01/24, 11/04/24, 11/06/24, 11/13/24,11/15/24 and 11/18/24. During an interview at 11:03 AM, Staff (S) 9, the Facility Manager, stated that pain should to be assessed pre (before) and post treatment. During an interview at 12:45 PM, S8, Manager of Clinical Services, stated that there should be a pre and post pain assessment per facility policy. 49828 A review of P2’s hemodialysis “Treatment Nurse Assessment,” on the “Treatment Details Report,” from 10/29/24 through 11/19/24, revealed the following: The post-treatment pain assessment was documented as “N/A” on the following treatment dates: 10/29/24, 11/05/24, 11/09/24, 11/12/24, 11/14/24, and 11/19/24. During an interview at 12:55 PM, S8, Manager of Clinical Services, stated that the staff are required to follow the facility policy for pre and post pain assessments. 51227 A review of P8’s hemodialysis “Treatment Nurse Assessment,” on the Treatment Details Report,” from 10/26/24 through 11/19/24, revealed the following: The post-treatment pain assessment was documented as “N/A” on the following treatment dates: 10/26/24, 10/31/24, 11/05/24, 11/09/24, 11/19/24. During an interview on 11/21/24 at 12:46 PM, Staff (S) 8, the Manager of Clinical Services stated that the staff are required to follow the facility policy for pre and post pain assessments. 50912 A review of P1’s “Treatment Nurse Assessment” on the “Treatment Details Report,” dated 10/28/24 through 11/18/24, revealed the following: The post-treatment pain assessment was documented as “N/A” on the following treatment dates: 10/28,10/30/24, 11/01/24, 11/04/24, 11/06/24, 11/08/24, 11/13/24, 11/15/24, 11/16/24 and 11/18/24. A review of P6’s “Treatment Nurse Assessment,” on the “Treatment Details Report” dated 10/28/24 through 11/15/24, revealed the following: The post-treatment pain assessment was documented as “N/A” on the following treatment dates: 10/28,10/30/24, 11/01/24, 11/04/24, 11/06/24, 11/09/24, 11/11/24, 11/13/24, and 11/15/24. A review of P7’s “Treatment Nurse Assessment,” on the “Treatment Details Report” dated 10/28/24 through 11/18/24, revealed the following: The post-treatment pain assessment was documented as “N/A” on the following treatment dates: 10/28,10/30/24, 11/01/24, 11/04/24, 11/06/24, 11/08/24, 11/11/24, 11/13/24, 11/15/24 and 11/18/24. Facility policy titled, “Patient Pain Assessment” revised June 2018, stated, “... Policy: 1. All patients are assessed for pain each time they dialyzer and post treatment. Documentation will be in the “other” section of the nursing assessment indicating the pain level and the scale maximum rating. Example 2/10 ...” Facility policy titled, “Pre-Intra-Post Treatment Data Collection, Monitoring and Nursing Assessment,” last 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 ... 5. Patient statement of well-being, level of pain or discomfort ...” N.J.A.C 8:43A-16.2(a)(14) 2. On 11/20/24 at 10:46 AM, during a tour of the medication preparation area, inside of the bottom cabinet on the right side of the clean sink was a box containing 37 BD (Becton-Dickinson) Tuberculin 26-gauge syringes in clear packaging with a manufacturer’s expiration date of 08/31/24. In the drawer to the right side of the clean sink, the following needles in individual packaging with manufacturer’s expiration dates were found: 65 packages of 21-gauge, 1-inch needles with expiration dates of 08/31/24 75 packages of 25-gauge, 1-inch needles with expiration dates of 03/31/24 One purple top, 5 ml (milliliter) blood specimen tube with expiration date of 11/30/23. During an interview at 10:52 AM, S5, Charge Nurse, confirmed the expired supplies. When asked who is responsible for checking for expired supplies, S5 stated that staff usually check the supplies for expiration dates and reports it to the charge nurse. At 10:57 AM, interview with S10, Facility Administrator, also confirmed that the supplies were expired and proceeded to discard the expired needles and syringes. Facility policy and procedure titled, “Infection Control for Dialysis Facilities,” revised October 2022, stated, “... 20 The expiration dates will be checked on all disposable supplies before the package is opened and contents are used ... 21 the contents of packages will not be used beyond the expiration date on the package ...” N.J.A.C. 8:43A-24.11(c)”