Davita Renal Center of Succasunna

“IC-CDC MMWR 2001 CFR(s): 494.30(a) The facility must demonstrate that it follows standard infection control precautions by implementing- (1)(i) The recommendations (with the exception of screening for hepatitis C), found in “Recommendations for Preventing Transmission of Infections Among Chronic Hemodialysis Patients,” developed by the Centers for Disease Control and Prevention, Morbidity and Mortality Weekly Report, volume 50, number RR05, April 27, 2001, pages 18 to 28. The Director of the Federal Register approves this incorporation by reference in accordance with 5 U.S.C. 552(a) and 1 CFR Part 51. This publication is available for inspection at the CMS Information Resource Center, 7500 Security Boulevard, Central Building, Baltimore, MD or at the National Archives and Records Administration (NARA). Copies may be obtained at the CMS Information Resource Center. For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal_register/code_of_regulations/ibr_locations.html. The recommendation found under section header “HBV-Infected Patients”, found on pages 27 and 28 of RR05 (“Recommendations for Preventing Transmission of Infections Among Chronic Hemodialysis Patients”), concerning isolation rooms, must be complied with by February 9, 2009. This Standard is not met as evidenced by: 49828 Based on one observation of the cleaning and disinfection following a blood spill, staff interviews, and review of facility documents, it was determined that the facility failed to implement facility policy that blood is cleaned and disinfected from all surfaces on the dialysis treatment floor. Findings include: On 07/21/25 at 10:45 AM, at the patient scale, a patient was observed bleeding from his/her hemodialysis access site. Staff (S)4 escorted the patient to the hemodialysis treatment station for assessment of his/her vascular access. S4 then inspected the scale where half dollar size drop of blood were observed on the floor near the scale. S4 then used a squeezable dispenser containing 1:10 (one part bleach to 10 parts water) bleach solution and soaked the visible blood, then used a clean towel to wipe it from the floor. S4 did not wipe the area a second time with 1:10 bleach solution as required by facility policy and procedure. During an interview at 10:52 AM, S4 stated that for any amount of blood they are required to use a 1:10 bleach solution to clean it. S4 confirmed he/she did not wipe the affected area a second time and stated they did not think they were required to go over the area a second time. Facility policy titled, “Infection Control for Dialysis Facilities,” revised April 2023, stated “... Disinfection ... 12. Cleaning and/or Disinfection of equipment and work surfaces will be performed as soon as possible following exposure to blood or other potentially infectious materials (i.e. used or brought into the station) and prior to returning to clean/designated area or removal from treatment area. A. Prior to routine disinfection, remove all visible blood, i. for visible blood or gross blood spills, a 1:10 (one to ten) bleach solution must be utilized. ii. After all visible blood is cleaned with 1:10 (one to ten) bleach solution, teammates are to use a new disposable towel soaked with 1:10 (one to ten) bleach solution and clean area a second time ...” N.J.A.C. 8:43A-24.4(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: 52927 Based on one of two observations of cleaning and disinfection of a hemodialysis station, staff interview and review of facility documents, it was determined that the facility failed to ensure that all surfaces of the hemodialysis station are cleaned and disinfected after patient use. Findings include: On 07/21/25 at 10:36 AM in Station 7, Staff (S)3 was observed cleaning and disinfecting the hemodialysis station after the patient was discharged. S3 used a bleach-soaked cloth to clean and disinfect the top, right side, back, prime bucket and tubing of the hemodialysis machine. S3 did not wipe the left side of the machine, which included the blood pressure (BP) cuff holder and a BP cuff in the holder. During an interview at 11:01 AM, a review of the findings was discussed with S3. S3 stated the BP cuff located in the holder is there for the next patient coming into the station because the patient needs a smaller BP cuff. S3 confirmed it should also be cleaned in between each patient. S3 then confirmed he/she did not clean the left side of the machine and the BP cuff holder. Facility policy titled, “Infection Control for Dialysis Facilities” revised 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-24.4(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: 39223 Based on one of one observation of total chlorine testing, staff interview, and review of facility documents, it was determined that the facility failed to ensure accurate testing of the water treatment system for chlorine/chloramine removal. Findings include: 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. ...” On 07/22/25 at 1:44 PM, Staff (S)9 and S10 performed a test for total chlorine levels in the Water Treatment Room. S9 obtained a sample of water and, after filling and dumping the cup with water three times, S9 dipped a RPC E-Z Chek Sensitive Total Chlorine Test Strip into the water sample. S9 then removed the strip from the water and together with S10, compared the test strip color to the color chart to determine the level of chlorine after 10 seconds. S9 and S10 did not wait 20 seconds to compare the strip to the color chart. This was not in accordance with manufacturer’s instructions for use. During an interview immediately after the observation, S9 stated that the wait time was only 10 or 15 seconds. A review of S9’s personnel file revealed that he/she was last evaluated on the chlorine testing procedure and determined to have a “Satisfactory performance of skill by teammate” on 12/16/24. N.J.A.C. 8:43A-24.10(a)(3)”

“PA-IDT MEMBERS/RESPONSIBILITIES CFR(s): 494.80 The facility’s interdisciplinary team consists of, at a minimum, the patient or the patient’s designee (if the patient chooses), a registered nurse, a physician treating the patient for ESRD, a social worker, and a dietitian. The interdisciplinary team is responsible for providing each patient with an individualized and comprehensive assessment of his or her needs. The comprehensive assessment must be used to develop the patient’s treatment plan and expectations for care. This Standard is not met as evidenced by: 49828 Based on two of five medical records reviewed (Patient [P]3 and P5), staff interviews, and review of facility policy and procedure, it was determined that the facility failed to ensure that the Physician completes a comprehensive assessment prior to developing a patient Plan of Care. Findings include: A review of P3’s medical record revealed two unstable Plans of Care (POC), dated 04/28/25, and 05/26/25 which lacked documented evidence that a physician’s comprehensive assessment was completed prior to the POC meeting. During an interview with Staff (S)2, it was confirmed that there was a lack of documented evidence that a comprehensive assessment was done prior to the POC. During an interview on 07/23/25 at 10:00 AM, S1 stated there was no evidence that comprehensive assessments were completed by P3’s physician during April and May of 2025. During an interview on 7/23/25 at 12:07 PM, S12 stated that P3 was in the hospital often during those months and he/she was unable to see P3 to complete a comprehensive assessment. S12 continued that he/she rounds “a couple times a month” at the facility and the patient was not present on the days he/she rounded for April and May. A review of P3’s hospitalizations revealed that the patient was hospitalized in April from 04/27/25 to 05/03/25. This left 26 days available for a comprehensive assessment to be completed. P3 was hospitalized in May from 05/01 to 05/03/25; 05/19/25 to 05/22/25, and 05/28 to 05/29/25. This left 22 days in May for a comprehensive assessment to be completed. 39223 A review of P5’s medical record revealed a POC meeting was held on 06/11/25. The physician’s comprehensive assessment for the meeting was dated 06/12/25, one day after the POC meeting was held. On 07/23/25 at 10:20 AM, the above was reviewed with S1, who confirmed that the physician’s assessment was documented one day after the meeting was completed. Facility policy titled, “Interdisciplinary Team (IDT) Patient Assessments and Plan Of Care,” revised October 2024, stated, “... Assessment: ... 7. A comprehensive re-assessment of each patient and revision in the plan of care will be conducted: ... At least monthly for unstable patients ...” N.J.A.C. 8.43A-24.13(c)”

“POC-GOALS=COMMUNITY-BASED STANDARDS CFR(s): 494.90 The interdisciplinary team as defined at §494.80 must develop and implement a written, individualized comprehensive plan of care that specifies the services necessary to address the patient’s needs, as identified by the comprehensive assessment and changes in the patient’s condition, and must include measurable and expected outcomes and estimated timetables to achieve these outcomes. The outcomes specified in the patient plan of care must be consistent with current evidence-based professionally-accepted clinical practice standards. This Standard is not met as evidenced by: 49828 Based on three of five medical records reviewed (Patient [P]1, P3, and P4), staff interview, and review of facility policy and procedure, it was determined that the facility failed to ensure implementation of hemodialysis prescription orders for dialysate temperature. Findings include: A review of P3’s medical record revealed the following: The “Treatment Orders” portion of the “IDT [Interdisciplinary Team] Patient Profile Worksheet” section of the medical record stated the hemodialysis prescription: “... In-Center Hemodialysis Treatment - [facility name] ... Start Date - 05/30/2025 ... Dialysate Temperature - 37 [degrees] C [Celsius] ...” A review of hemodialysis treatment sheets from 06/30/25 to 07/18/25 indicated that the prescribed temperature (temp) of 37 degrees C was not administered in accordance with the physician order above on the following treatment dates: On 07/02/25, the machine temperature was documented as 35.2 degrees C. On 07/04/25, the machine temperature was documented as 36.5 degrees C. On 07/09/25, the machine temperature was documented as 36.5 degrees C. On 07/11/25, the machine temperature was documented as 36.5 degrees C. On 07/16/25, the machine temperature was documented as 35.2 degrees C. During an interview on 07/23/25 at 10:28 AM, Staff (S)10 stated the staff member should adjust the temperature of the dialysate to match the patient’s ordered prescription. S10 confirmed that on 07/02, 07/04, 07/09, 07/11, and 07/16, there was no documented evidence that staff followed P3’s prescribed dialysate temperature order. The medical record did not contain documented evidence that the physician was aware of the change in temperatures on the above dates. 51227 A review of P1’s medical record revealed the following: The “Active Treatment Orders” portion of the “Patient Summary Report” section of the medical record stated the hemodialysis prescription: “ ... In-Center Hemodialysis Treatment - [facility name] ... Dialysate Temperature - 36 [degrees] C ... Start Date - 06/25/2025 ... “ A review of hemodialysis treatment sheets from 06/30/25 to 07/18/25 indicated that the prescribed temperature of 36 degrees C was not administered in accordance with the physician order above on the following treatment dates: On 06/30/25, the machine temperature was documented as 36.8 degrees C. On 07/04/25, the machine temperature was documented as 36.6 degrees C. On 07/04/25, the machine temperature was documented as 36.6 degrees C. A review of P4’s medical record revealed the following: The “Active Treatment Orders” portion of the “Patient Summary Report” section of the medical record stated the hemodialysis prescription: “ ... In-Center Hemodialysis Treatment - [facility name] ... Dialysate Temperature - 36.5 [degrees] C ... Start Date - 07/01/2025 ... “ On 07/01/25, the machine temperature was documented as 35.2 degrees C. On 07/05/25, the machine temperature was documented as 35.7 degrees C. On 07/12/25, the machine temperature was documented as 36.0 degrees C. During an interview on 07/23/25 at 10:28 AM, Staff (S)10 stated the staff member should adjust the temperature of the dialysate to match the patient’s ordered prescription. S10 confirmed that on the dates listed above, there was no documented evidence that staff followed P1’s and P4’s prescribed dialysate temperature order. The medical record did not contain documented evidence that the physician was aware of the change in temperatures on the above dates. Facility policy titled, “Pre-Intra-Post Treatment Data Collection, Monitoring, and Nursing Assessment,” revised April 2025 stated, “... Policy: ... 3. Patient identity, prescription and machine settings are verified by teammate prior to initiation of treatment ... The prescription components are confirmed by a licensed nurse within one (1) hour of treatment initiation along with the nursing assessment or as allowable by state law ...” N.J.A.C. 8:43A-24.4(a) N.J.A.C. 8:43A-24.6(d)(4)”

“POC-MANAGE VOLUME STATUS CFR(s): 494.90(a)(1) The plan of care must address, but not be limited to, the following: (1) Dose of dialysis. The interdisciplinary team must provide the necessary care and services to manage the patient’s volume status; This Standard is not met as evidenced by: 52927 Based on medical record review, staff interview and review of facility documents, it was determined that the facility failed to develop and implement a plan of care to manage each patient’s volume status in six of nine hemodialysis treatments for Patient (P)2. Findings include: A review of P2’s medical record revealed the following: A Plan of Care, dated 06/25/25, stated, “Fluid/BP ... Blood pressure within range.” The IDT [Interdisciplinary Team] Patient Profile Worksheet, stated, “MEDICATION(S) ... IN-CENTER MEDICATION ... Normal Saline Solution 0.9% NaCl [sodium chloride]... DOSE/ROUTE/FREQUENCY ... 100 Milliliter [ml], Intravenous, As needed.” The medication record lacked evidence of an indication for the as needed administration of the intravenous normal saline solution. A review of P2’s Treatment Details Report were reviewed from 06/30/25 through 07/18/25 and revealed the following: On 07/02/25 at 11:11 AM, P2’s hemodialysis treatment was initiated with a BP of “96/53.” At 11:41 AM, P2’s BP was “85/54” and a corresponding comment by the RN stated “bp trending down; recheck.” The flowsheet lacked evidence that the BP was rechecked until 12:10 PM. The flowsheet lacked evidence that any interventions were performed in response to P2’s decreased BP. On 07/04/25 at 11:03 AM, P2’s hemodialysis treatment was initiated with a BP of “92/50.” At 11:33 AM, P2’s BP was “95/45” and a corresponding RN note stated, “Patient monitored; watching tv no complications.” P2’s BP was not rechecked until one hour later at 12:33 PM and was “89/40.” An RN comment stated, “hypotensive [low blood pressure] but asymptomatic [without symptoms]; NS 100ml given.” At 12:43 PM, P2’s BP was “88/41” and an RN note stated, “bp dropped again; pt [patient]denies dizziness; NS 100ml given since pt is below target weight; will continue to monitor pt.” At 13:03 (1:03 PM), P2’s BP was 90/45 and an RN note stated, “hypotensive but asymptomatic; will continue to monitor.” The medical record lacked evidence of any additional interventions related to P2’s hypotension or that the RN communicated the decreased BP’s to the patients physician. On 07/07/25 at 11:09 AM, P2’s hemodialysis treatment was initiated with a BP of “107/69.” At 11:11 AM, P2’s BP was “95/45” and an RN note stated, “BP/HR [heart rate] stable.” At 11:40 AM, P2’s BP was “93/40” and an RN note stated, “Patient monitored; watching tv no complications.” At 12:09 PM, P2’s BP was “96/47” and an RN note stated, “Patient awake; alert; and states no complaints at this time.” The medical record lacked evidence of any interventions related to P2’s hypotension. The medical record lacked evidence that the physician was notified of P2’s hypotension. On 07/14/25 at 11:24 AM, P2’s hemodialysis treatment was initiated with a BP of “129/109” by the PCT. There was no evidence that the BP was rechecked until 11:54 AM, when the BP was documented as “95/51.” At 13:02 (1:02 PM), P2’s BP was “100/48” and a comment by the PCT stated, “Patient awake; alert; and states no complaints at this time.” The flowsheet lacked evidence that the PCT made the RN aware of the decreased diastolic BP. At 13:32 (1:32 PM), P2’s BP was “77/51” and an RN note stated, “Patient awake; alert; and states no complaints at this time; BP low; rechecking BP.” The recheck at 13:49 (1:49 PM) was “96/47” and the same RN commented, “BP improved.” At 14:04 (2:04 PM), P2’s BP was “94/35” and an RN note stated, “Patient awake; alert; and states no complaints at this time.” The BP was rechecked one minute later at 14:05 (2:05 PM) and was “70/52” with an RN comment that stated, “Rechecking V/S [vital signs].” At 14:06 (2:06 PM), P2’s BP was “97/47” and an RN note stated, “Patient appears to be tolerating treatment well at this time; BP improved but still low.” Treatment was terminated at 14:20 (2:20 PM) with P2’s BP documented as “99/50.” The medical record lacked evidence of any interventions related to P2’s hypotension. The medical record lacked evidence that the physician was notified of P2’s hypotension. On 07/16/25 at 11:03 AM, P2’s hemodialysis treatment was initiated with a BP of “96/54.” At 11:39 AM, P2’s BP was “94/45” and an RN note stated, “hypotensive but asymptomatic; will continue to monitor pt.” P2’s BP was not rechecked until 49 minutes later at 12:28 PM. On 07/18/25 at 11:11 AM, P2’s hemodialysis treatment was initiated by the RN with a BP of “77/48.” A comment by the RN stated, “rechecking V/S.” Upon recheck at 11:14 AM, P2’s BP was “87/38” and an RN note stated, “Treatment started without complications; Patient access cannulated without difficulty; Patient blood pressure low; asymptomatic; will monitor.” At 11:38 PM, P2’s BP was “94/42” and at 12:32 PM, the BP was “97/38.” Both BP’s were acknowledged by an RN. The medical record lacked evidence of any interventions related to P2’s hypotension. The medical record lacked evidence that the physician was notified of P2’s hypotension. During an interview with Staff (S)10 on 07/23/25 at 10:25 AM, he/she confirmed the above treatment sheets lacked documentation that the MD was informed of P2’s abnormal BP’s during hemodialysis treatment. S10 confirmed there were no orders or notes by an MD documented in P2’s medical record addressing abnormal BPs. During a phone interview with P2’s physician on 07/23/25 at 12:00 PM, S12 confirmed there was no order or note documented by an MD in P2’s medical record addressing abnormal BP’s. S12 confirmed he/she was aware of P2’s low BP and stated “a note or order should be present in the patient’s medical record related to addressing P2’s BP. As long as the patient is awake, alert and not tachycardic (a fast heart rate), the BP is not important.” S12 stated that the facility might not be using the correct size BP cuff on this patient. Facility policy titled, “PRE-INTRA-POST TREATMENT DATE COLLECTION, MONITORING AND NURSING ASSESSMENT,” revised April 2024, stated “... INTRADIALYTIC DATA COLLECTION/ASSESSMENT ... 9. ... A. Vital signs and treatment monitoring ... iii. Non-nocturnal treatments are completed at least every thirty (30) minutes. ... ABNORMAL FINDINGS ... Unless other abnormal parameters are established by the facility Governing Body and documented in the Governing Body Meeting minutes, the following are considered abnormal findings and should be reported to the licensed nurse and documented in the patient ’ s medical record ... Members of the patient care team should report ANY changes in patient conditions or concerns of patient well- being immediately to the licensed nurse at any time ... Blood Pressure: Pre [before]- dialysis: Systolic: great than 180 mm/Hg [millimeters of mercury] or less than 90 mm/Hg, Diastolic greater than or equal to 100 mm/Hg or less than 50 mm/Hg ... Blood Pressure- Intradialytic [occurring during hemodialysis]: Systolic greater than 190 mm/Hg or less than 90 mm/Hg, Diastolic greater than or equal to 100 mm/Hg or less than 50 mm/Hg.” Facility policy titled, “HYPOTENSION,” revised October 2023, stated “... Procedure ... 1. Take vital signs. Place patient in a flat supine position. 2. Decrease ultrafiltration rate (UFR) or turn off UFR depending on patient’s condition. 3. Administer normal saline bolus of 100-200 ml for severe hypotensive symptoms. Patient care technicians may give up to 200 mL and will inform licensed nurse of intervention ... For less severe signs of hypotension give oral fluids (i.e. water). 4. Administer oxygen per physician’s order. 5. Continue monitoring blood pressure. If blood pressure stabilizes, evaluate Target Weight and adjust UF [ultrafiltration] as determined by patient’s condition. 6. If patient continues to show signs and symptoms of hypotension, the licensed nurse will notify physician and follow physician’s orders. 7. Document event, orders, treatment and patient response in the patient’s electronic health record.” N.J.A.C. 8:43A-24.13(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: 51227 Based on observations, staff interview, and review of facility policy, it was determined that the facility failed to ensure: 1) Implementation of the policy for medication administration on one of two observations; and 2) supplies are monitored and discarded according to the manufacturer’s expiration dates. Findings include: 1. On 07/21/25 at 12:15 PM, in Station 5, Staff (S)3 initiated hemodialysis through a Central Venous Catheter (CVC, a type of vascular access used for hemodialysis). The following was observed: S3 attached a prefilled Benadryl syringe to the blue (venous) luer-loc line and slowly injected the Benadryl. S3 then proceeded to attach a pre-filled heparin syringe to the blue (venous) access luer-loc and slowly injected the heparin with a back-and-forth motion. S3 did not flush the CVC venous line with saline before administering a new medication in accordance with facility policy. During an interview at 12:35 PM, S3 stated he/she was unsure if the CVC line needed to be flushed between medications. During an interview on 07/23/25 at 10:35 AM, S10 stated the CVC venous line should be flushed with saline before giving another medication. Facility policy titled, “Preparation and Administration of Parenteral Medications (Non-ESA, Non-PARSABIV),” revised April 2024, stated, “... Administration of Parenteral Medications ... 8. If more than one (1) medication is being administered, flush injection luer lock line in between medication administration with saline ...” N.J.A.C. 8:43A-9.3(a) 49828 2. On 07/21/25 at 11:04 AM, at the Nurse’s Station, in the third bottom drawer labeled, “blood collection tubes,” to the left of the computer, were green top blood sample tubes. Upon inspection of the expiration dates it was revealed that 10 green tubes were expired. Four had expired on 04/30/25, another four on 05/31/25, and two had expired on 06/30/25. During an interview at 11:11 AM, S2 confirmed that the 10 tubes were expired and stated they should not be available for use. 52927 On 07/21/25 at 9:59 AM, in a storage container across from Station 2, there were 28 expired reusable packaging container (RPC) caps in a drawer. Four had expired on 03/31/25 and 24 had expired on 05/26/24. At 10:10 AM, in a storage container located across from Station 6, there were 23 expired RPC caps in the drawer with an expiration date of 05/26/24. During an interview at 10:02 AM, S2 confirmed the supplies were expired and stated, “we should have looked at the expiration date before using.” S2 discarded the expired supplies. Facility policy titled, “Infection Control for Dialysis Facilities,” revised April 2023, stated “ SUPPLIES ... b. expiration date and package integrity will be verified prior to use.” N.J.A.C. 8:43A-24.4(a)”