Davita Watertown Dialysis

“EP Training and Testing CFR(s): §403.748(d), §416.54(d), §418.113(d), §441.184(d), §460.84(d), §482.15(d), §483.73(d), §483.475(d), §484.102(d), §485.68(d), §485.542(d), §485.625(d), §485.727(d), §485.920(d), §486.360(d), §491.12(d), §494.62(d). *[For RNCHIs at §403.748, ASCs at §416.54, Hospice at §418.113, PRTFs at §441.184, PACE at §460.84, Hospitals at §482.15, HHAs at §484.102, CORFs at §485.68, REHs at §485.542, CAHs at §486.625, “Organizations” under 485.727, CMHCs at §485.920, OPOs at §486.360, and RHC/FHQs at §491.12:] (d) Training and testing. The [facility] must develop and maintain an emergency preparedness training and testing program that is based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, policies and procedures at paragraph (b) of this section, and the communication plan at paragraph (c) of this section. The training and testing program must be reviewed and updated at least every 2 years. *[For LTC facilities at §483.73(d):] (d) Training and testing. The LTC facility must develop and maintain an emergency preparedness training and testing program that is based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, policies and procedures at paragraph (b) of this section, and the communication plan at paragraph (c) of this section. The training and testing program must be reviewed and updated at least annually. *[For ICF/IIDs at §483.475(d):] Training and testing. The ICF/IID must develop and maintain an emergency preparedness training and testing program that is based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, policies and procedures at paragraph (b) of this section, and the communication plan at paragraph (c) of this section. The training and testing program must be reviewed and updated at least every 2 years. The ICF/IID must meet the requirements for evacuation drills and training at §483.470(i). *[For ESRD Facilities at §494.62(d):] Training, testing, and orientation. The dialysis facility must develop and maintain an emergency preparedness training, testing and patient orientation program that is based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, policies and procedures at paragraph (b) of this section, and the communication plan at paragraph (c) of this section. The training, testing and orientation program must be evaluated and updated at every 2 years. This Standard is not met as evidenced by: 29972 Based on record review and interview the facility staff failed to ensure all staff are trained in the Emergency Preparedness plan in 1 of 5 personnel files reviewed (Social Worker (SW) D), in a total sample of 5 personnel files reviewed. Findings Include: Review of policy and procedure #4-07-01 titled, “Facility Emergency Management Plan” last reviewed April 2024 revealed that teammates will be trained annually and upon hire on the following: “1. Policy facility Emergency Management Plan...2. Appropriate hazard policies...3. Clinical emergency policies...4. Facility specific emergency response procedures.” Per policy, the training will be documented in the teammate file. Per interview with SW D on 05/07/2024 beginning at 8:53 AM, SW D was not aware of the shelter in place location or the evacuation meeting point outside the facility. SW D stated that she/he transferred to this facility from another location approximately 3 months ago and has not been educated on the Emergency Preparedness plan at this location. Per interview with Clinical Service Manager (CSM) B on 05/07/2024 at 11:05 AM, CSM B stated that staff should receive education on the Emergency Preparedness plan within the first 2 days of working at the facility.”

“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: 29972 Based on observations and interview, staff failed to maintain a sanitary environment free from potential infection control risk in 1 of 3 areas observed (Water room), in a total sample of 3 areas observed. Findings Include: On 05/06/2024 beginning at 12:15 PM, while interviewing Patient Care Technician (PCT) G in the Water Room, observed the following: - Large amount of white powder/residue on the floor around the Backflow Preventer, Water Heaters, and Brine Tank. - Large amount of white powder/residue on the top of the Dry Acid Equipment. During interview with PCT G at the time of the observation, PCT G confirmed the findings and stated that the floor and the Dry Acid equipment should be cleaned daily. PCT G stated that the closing PCT is responsible for cleaning the floor and the PCT who makes the Acid should be ensuring the equipment is cleaned after use.”

“IC-GOWNS, SHIELDS/MASKS-NO STAFF EAT/DRINK CFR(s): 494.30(a)(1)(i) Staff members should wear gowns, face shields, eye wear, or masks to protect themselves and prevent soiling of clothing when performing procedures during which spurting or spattering of blood might occur (e.g., during initiation and termination of dialysis, cleaning of dialyzers, and centrifugation of blood). Staff members should not eat, drink, or smoke in the dialysis treatment area or in the laboratory. This Standard is not met as evidenced by: 29972 Based on observation, record review, and interview facility staff failed to wear personal protective equipment (PPE) when administering intravenous (IV) medications in 1 of 2 observations of medication administration (Patient (Pt) #6), in a total sample of 11 patient observations of care. Findings Include: Review of policy and procedure #1-05-01 titled, “Infection Control for Dialysis Facilities” last reviewed April 2023 revealed the following: - “Appropriate PPE (gown, gloves, eye protection, face shield) will be worn whenever there is the potential for contact with body fluid...” On 05/06/2024 at 12:00 PM, observed Registered Nurse (RN) E administering IV medications via Pt #6’s blood lines while on dialysis treatment; RN E did not don a faceshield to protect eyes, nose, and mouth from potential blood splatter. During interview with Facility Administrator (FA) A and Clinical Services Manager (CSM) B on 05/07/2024 beginning at 12:30 PM, while discussing observations, FA A and CSM B stated that staff should don a face shield when administering IV medications.”

“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: 29972 Based on observation, record review, and interview staff failed to clean and disinfect all the equipment at the dialysis station between patients to prevent cross contamination in 2 of 2 observations of dialysis station cleaning (Station (St) #3, 1); and failed to disinfect equipment used for patient transfers in 1 of 1 observations of patient transfers (Pt #7), in a total sample of 3 observations of equipment cleaning. Findings Include: Review of policy and procedure #1-05-01 titled, “Infection Control for Dialysis Facilities” last reviewed April 2023 revealed the following: -“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).” On 05/06/2024 at 9:48 AM, observed Registered Nurse (RN) E clean and disinfect the dialysis machine at St #3. RN E did not clean the dialysate hoses and Hansen connectors and hoses attached to the dialysis machine. On 05/06/2024 at 10:00 AM, observed Patient Care Technician (PCT) G clean and disinfect the dialysis chair at St #3. PCT G did not clean the following: -Basket attached to the dialysis machine -Blood Pressure cuff in the basket -Emergency disconnect bag hanging from TV -TV and TV arm -Crevices between the seat cushions connecting the back of the chair to the seat of the chair -Counter tops at the dialysis station On 05/06/2024 at 9:55 AM, observed Patient Care Technician (PCT) G clean and disinfect dialysis St #1. PCT G did not clean the following: -Dialysate hoses -Hansen connectors and hoses -Primewaste container--inside and outside -Basket attached to the dialysis machine -Blood Pressure cuff in the basket -Emergency disconnect bag hanging from TV -TV and TV arm -Crevices between the seat cushions connecting the back of the chair to the seat of the chair -Counter tops at the dialysis station On 05/06/2024 at 11:50 AM, observed RN E and RN F transferring Pt #7 from the dialysis chair to a wheel chair using a Hoyer lift post dialysis treatment at St #6. RN E and RN F did not clean and disinfect the Hoyer lift after use and before returning to the “clean” common storage area. During interview with Facility Administrator (FA) A and Clinical Services Manager (CSM) B on 05/07/2024 beginning at 12:30 PM, while discussing observations, FA A and CSM B stated that the above areas of the station should be cleaned between patients as per policy. CSM B and FA A stated that the Hoyer lift should be cleaned after each use.”

“IC-ASEPTIC TECHNIQUES FOR IV MEDS CFR(s): 494.30(b)(2) [The facility must-] (2) Ensure that clinical staff demonstrate compliance with current aseptic techniques when dispensing and administering intravenous medications from vials and ampules; and This Standard is not met as evidenced by: 29972 Based on observation, record review, and interview the facility staff failed to administer medications using aseptic technique in 1 of 2 observations of medication administration (Patient (Pt) #4), in a total sample of 11 observations of patient care. Findings Include: Review of policy and procedure #1-06-01 titled, “Medication Policy” reviewed October 2023 revealed, “All teammates administering medications must utilize aseptic technique.” On 05/06/2024 at 11:40 AM, observed Registered Nurse (RN) E drawing up intravenous (IV) medications to administer to Pt #4. RN E did not wipe the rubber stopper of the medication vial prior to inserting the needle and drawing up Pt #4’s IV medications. During interview with Facility Administrator (FA) A and Clinical Services Manager (CSM) B on 05/07/2024 beginning at 12:30 PM, while discussing observations, FA A and CSM B confirmed that staff should use an alcohol wipe to clean the rubber stopper of the medication vial prior to drawing up IV medication.”

“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: 29972 Based on record review, observation and interview, staff failed to ensure Central Venous Catheters (CVCs) are accessed in a manner to prevent potential cross contamination in 2 of 4 patients observed with a CVC (Patient (Pt) #1, 6) in a total sample of 4 patients observed with a CVC. Findings include: Review of policy and procedures #1-04-02B titled, “Central Venous Catheter....” last reviewed October 2023 revealed the following: -“Perform a 15 second hub scrub of the CVC during the process of connecting or disconnecting from the blood lines, including line reversal, or if the patient is disconnected during treatment for any reason.” Review of the CVC procedure “Upon completion of dialysis” revealed to, “...Aseptically disconnect arterial blood line from arterial CVC limb. Attach a 10 milliter (ml) syringe filled with normal saline to arterial catheter limb and push normal saline into arterial port...” Per review, the procedure in the policy did not include to perform a 15 second hub scrub after disconnecting the blood lines and before attaching normal saline syringe, to ensure potential contaminates are not pushed into the blood stream. Review of CDC (Centers for Disease Control) “Hemodialysis Central Venous Catheter Scrub the Hub Protocol” last reviewed September 26, 2016 revealed, “Catheter hubs should be disinfected again after disconnecting from bloodlines and before replacing a new cap at the end of a treatment. This should be done in a manner similar to that used when disinfecting the hub prior to accessing. On 05/06/2024 beginning at 2:50 PM, observed Patient Care Technician (PCT) G discontinuing Pt #6’s dialysis treatment using a CVC. PCT G disconnected the blood lines from the CVC hubs, attached a 10 ml normal saline syringe and flushed the CVC ports; PCT G did not perform the CVC hub scrub immediately after disconnection of the blood lines as per CDC guidelines and facility policy. On 05/07/2024 beginning at 9:45 AM, observed PCT G discontinuing Pt #1’s dialysis treatment using a CVC. PCT G disconnected the blood lines from the CVC hubs, attached a 10 ml normal saline syringe and flushed the CVC ports; PCT G did not perform the CVC hub scrub immediately after disconnection of the blood lines as per CDC guidelines and facility policy. During interview with Facility Administrator (FA) A and Clinical Services Manager (CSM) B on 05/07/2024 beginning at 12:30 PM, while discussing observations, FA A and CSM B stated that the facility follows CDC guidelines for CVC Scrub the Hub. CSM B confirmed that the CVC procedure in the policy was inconsistent with the CDC guidelines.”

“PR-RIGHTS POSTED,STATE/NW ONTACT INFO CFR(s): 494.70(c) The dialysis facility must prominently display a copy of the patient’s rights in the facility, including the current State agency and ESRD network mailing addresses and telephone complaint numbers, where it can be easily seen and read by patients. This Standard is not met as evidenced by: 29972 Based on observation and interview staff failed to post the State agency and Network 11 patient rights contact info in the dialysis facility easily seen by patients in 1 of 1 observations (in-center dialysis), in a total sample of 1 observation. Findings Include: Per observations of the dialysis treatment area and waiting room beginning on 05/07/2024 at 12:30 PM, there was no evidence of the State agency and Network 11’s contact info (mailing address and complaint telephone number) being posted in a place easily seen by patients. During interview with Facility Administrator (FA) A and Clinical Services Manager (CSM) B on 05/07/2024 beginning at 12:30 PM, while discussing observations, FA A and CSM B confirmed that the information was not posted in the facility at the time of the observation.”

“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: 29972 43264 Based on record review and interview, the facility staff failed to develop measurable and individualized Interdisciplinary Team (IDT) Plan of Care (POC) goals for Vascular Access and Fluid Management needs in 3 of 5 patient records reviewed (Patient (Pt) #3, 4, 5) in a total sample of 5 medical records reviewed. Findings include: Review of the policy #1-14-01 titled, Interdisciplinary Team (IDT) Patient Assessment and Plan of Care” last reviewed July 2023 revealed the following: - “The facility’s interdisciplinary team will develop and implement a written, individualized comprehensive plan of care that specifies the services necessary to address the patient’s needs...and will include measurable and expected outcomes and estimated timetables to achieve these outcomes...” Vascular Access: Review of Pt # 3’s medical record, revealed: -03/19/2024: Treatment Order for In-Center Hemodialysis 3 times per/week via Central Venous Catheter (CVC) access in right chest (placed 06/01/2023). -03/20/2024: Arteriovenous Fistula (AVF) access site placed in Upper Arm (left). -IDT POC meeting dated 03/20/2024 revealed the Vascular Access POC goal was to “Support maintenance and functioning of permanent dialysis access”; this goal was not measurable or individualized. Review of Pt #4’s medical record, revealed: -04/09/2024: Treatment Order for In-Center Hemodialysis 3 times per/week via CVC access in right chest (placed 04/01/2024). -IDT POC meeting dated 05/02/2024 revealed the Vascular Access POC goal was to “Support maintenance and functioning of permanent dialysis access”; this goal was not measurable or individualized. Review of Pt #5’s medical record revealed the following: -CVC “Start Use date” was 03/15/2023 and “Last Used date” was 05/06/2024; -Arteriovenous Fistula was placed on 04/30/2024 and the “Start Use Date” was blank; -Active Treatment Orders dated 05/06/2024 revealed that Pt #5 was using the CVC access site for dialysis treatment. -IDT POC meeting dated 02/21/2024 revealed the Vascular Access POC goal was to “Support maintenance and functioning of permanent dialysis access”; this goal was not measurable or individualized. Fluid Management: Review of Pt #5’s Comprehensive Assessment Report dated 02/16/2024 revealed Pt #5’s ordered Ultrafiltration Rate (UFR) was < 13 ml (milliters) per kilogram (kg) per Hour (hr) (13ml/kg/hr) of fluid to be removed during dialysis treatment. Review of Pt #5’s UFR from 01/22/2024 to 02/16/2024 revealed the UFR ranged between 9.7 to 24.9 and was out of the ordered parameters 10 of 11 of Pt #5’s dialysis treatments. Review of Pt #5’s Comprehensive Fluid IDT POC dated 02/21/2024 revealed there no documentation of an individualized and measurable POC addressing Pt #5 not meeting the ordered UFR. During interview with Facility Administrator (FA) A and Clinical Services Manager (CSM) B on 05/08/2024 beginning at 12:20 PM, while discussing medical record findings, FA A and CSM B confirmed the findings and CSM B stated that the POC should be measurable and individualized.”

“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: 29972 Based on record review and interview, staff failed to ensure that nursing assessments and evaluations address Fluid management needs in 5 of 5 patient records reviewed (Patients (Pt) #1, 2, 3, 4, 5); and failed to ensure that the Registered Nurse (RN) performs an assessment when blood pressure (BP) and/or heart rate are out of parameters as per policy in 4 of 5 patient records reviewed (Pt #1, 2, 4, 5), in a total sample of 5 medical records reviewed. Findings Include: Review of policy and procedure #1-03-08 titled, “Pre-Intra-Post Treatment Data Collection, Monitoring and Nursing Assessment” last reviewed April 2024 revealed the following: - “If abnormal finding is reported to the licensed nurse pre-treatment, the nurse will assess the patient prior to the initiation of dialysis.” -Vital signs and treatment monitoring...Non-nocturnal treatments are completed at least every 30 minutes. - “Abnormal findings or findings outside of any patient specific physician ordered parameters will be reported to the licensed nurse immediately. The licensed nurse will use his/her clinical judgement based on individual patient needs to determine if any clinical interventions are necessary.” - “If an abnormal finding or concern is identified post treatment, this needs to be reported to the licensed nurse. The licensed nurse will assess the patient prior to discharge.” - “All findings, interventions and patient response will be documented in the patient’s medical record.” - Abnormal findings include: Fluid Status Pre-Treatment...”Removal goal not to exceed maximum ordered by physician...Post-treatment: If patient is above or below 1 kilogram from the target weight (TW);” - Abnormal Findings include: Blood Pressure-Intradialytic (during treatment)...”Systolic (blood pressure) greater than 180...or less than 90...Diastolic (blood pressure) greater than or equal to 100 or less than 50...” - Abnormal Findings include: Blood Pressure Post Treatment... “Standing systolic BP greater than 140...Standing diastolic BP greater than 90...If patient is not able to stand, document the reason...” -Abnormal findings include: Heart or pulse rate of “Less than 60 beats per minute or greater that 100 beats per minute...” Fluid Assessment and Evaluations: Review of Pt #1’s treatment sheets revealed the following: -On 04/24/2024: Pt #1’s TW (target weight) was 135.2 kg, pre-treatment weight was 135.8 kg and post-treatment weight was 133.2 kg; 2.0 kg below TW. There was no documentation of nursing interventions addressing Pt #1’s post weight being >1 kg below the TW as per policy. Review of Pt #2’s treatment sheets revealed the following: - On 05/04/2024: Pt #2’s ordered Maximum Ultrafiltration rate (UFR) was 13 Milliliter per kilogram per hour (13 ml/kg/hr); Pt #2’s Actual UFR during treatment was 15.4 ml/kg/hour (more than maximum ordered UFR). There was no documentation recognizing and addressing Pt #2’s UFR exceeding the prescribed rate. Review of Pt #3’s treatment sheets revealed the following: -On 04/23/2024: Pt #3’s dialysis treatment ended at 10:35 AM and the nurse did not document a post-treatment assessment until 3:43 PM; 5 hours and 8 minutes later. -On 05/02/2024: Pt #3’s dialysis treatment ended at 10:30 AM and the nurse did not document a post-treatment assessment until 1:48 PM; 3 hours and 18 minutes later. -On 05/04/2024: Pt #3’s dialysis treatment ended at 10:29 AM and the nurse did not document a post-treatment assessment until 12:02 PM; 1 hours and 33 minutes later. Review of Pt #4’s treatment sheets revealed the following: -On 04/26/2024: Pt #4’s ordered Maximum UFR was <13 ml/kg/hour; Pt #4’s Actual UFR during treatment was 17.7 ml/kg/hour (more than maximum ordered UFR). There was no documentation recognizing and addressing Pt #4’s UFR exceeding the prescribed rate. Review of Pt #5’s Treatment Sheet revealed the following: -On 05/03/2024: Pt #5’s ordered Maximum Ultrafiltration rate (UFR) was 13 ml/kg/hr; Pt #5’s Actual UFR during treatment was 22.7 ml/kg/hour (more than maximum ordered UFR). There was no documentation recognizing and addressing Pt #5’s UFR exceeding the prescribed rate. -On 05/01/2024: Pt #5’s ordered Maximum UFR is 13 ml/kg/hr; Pt #5’s Actual UFR during treatment was 26.8 ml/kg/hour (more than maximum ordered UFR). There was no documentation recognizing and addressing Pt #5’s UFR exceeding the prescribed rate. -On 04/29/2024: Pt #5’s ordered Maximum UFR is 13 ml/kg/hr; Pt #5’s Actual UFR during treatment was 25.5 ml/kg/hour (more than maximum ordered UFR). There was no documentation recognizing and addressing Pt #5’s UFR exceeding the prescribed rate. -On 04/29/2024 Pt #5’s TW was 57.0 kg; Pt #5’s post weight was 58.8 kg (1.8 kg over TW). There was no documentation of nursing interventions addressing Pt #5’s post weight being >1 kg over the TW as per policy. Blood Pressure/Heart Rate nursing assessments and monitoring: Review of Pt #1’s treatment sheets revealed the following: -On 05/02/2024: Intradialytic vital signs (including Blood Pressure (BP) and heart rate) were documented at 8:34 AM and then not again until 9:43 AM; 1 hour 9 minutes later (should be every 30 minutes per policy). Review of Pt #2’s treatment sheets revealed the following: -On 04/25/2024: Intradialytic vital signs (including BP and heart rate) were documented at 6:33 AM and then not again until 7:33 AM; 1 hour later (should be every 30 minutes as per policy). -On 05/02/2024: At 8:33 AM, Pt #2’s Intradialytic BP was 97/35 (Diastolic <50), there was no documented evidence of a RN assessment addressing Pt #2’s low BP as per policy. -On 04/25/2024: At 8:58 AM, Pt #2’s Intradialytic BP was 88/70 (Systolic < 90), there was no documented evidence of a RN assessment addressing Pt #2’s low BP as per policy. Review of Pt #4’s treatment sheets revealed the following: -On 05/03/2024: Intradialytic vital signs (including BP and heart rate) were documented at 1:02 PM and then not again until 2:02 PM; 1 hour later (should be every 30 minutes per policy). Review of Pt #5’s Treatment Sheets revealed the following: -On 05/01/2024 beginning at 09:02 AM Pt #5’s sitting heart rate post dialysis was 107 beats per minute and the standing heart rate was 118 (normal 60-100). There was no documented evidence of the RN recognizing and addressing Pt #5’s heart rate being out of parameters as per policy. -On 04/29/2024 beginning at 9:05 AM Pt #5’s sitting blood pressure (BP) was 197/121 (systolic >180; diastolic >100) and a heart rate of 118 (normal 60-100); standing BP was 197/128 and heart rate 128. There was no documented evidence of the RN assessing Pt #5 for signs and symptoms of hypertension and increased heart rate as per policy. -On 04/29/2024 at 06:02 AM, Pt #5’s BP was 180/116 (Systolic >180; Diastolic >100); there was no RN assessment addressing Pt #5’s BP out of parameters until 6:43 AM (41 minutes later). Pt #5’s BP was 183/119 at 7:02 AM and 185/108 at 7:32 AM, there was no documented evidence of the RN assessing for signs and symptoms of hypertension. During interview with Facility Administrator (FA) A and Clinical Services Manager (CSM) B on 05/08/2024 beginning at 12:20 PM, while discussing medical record findings, FA A and CSM B confirmed the findings and stated the RN should assess patients when their vital signs (BP and Heart rate) are out of parameters before, during, and after treatment as per policy. Per CSM B staff should be following Provider orders related to Maximum UFR during treatment. CSM B stated that RNs should be documenting interventions and contacting the Provider when a patient is >1.0 kg over or under TW post treatment as per policy. 43264”

“POC-COMPLETED/SIGNED BY IDT & PT CFR(s): 494.90(b)(1) The patient’s plan of care must- (i) Be completed by the interdisciplinary team, including the patient if the patient desires; and (ii) Be signed by the team members, including the patient or the patient’s designee; or, if the patient chooses not to sign the plan of care, this choice must be documented on the plan of care, along with the reason the signature was not provided. This Standard is not met as evidenced by: 43264 Based on record review and interview, the facility failed to ensure that all members of the interdisciplinary team (IDT) participate in the plan of care (POC) meetings as evidence by signing the plan of care in 1 of 5 patient records reviewed (Patient (Pt) #4), in a total sample of 5 medical records reviewed. Findings Include: Review of the policy #1-14-01 titled, Interdisciplinary Team (IDT) Patient Assessment and Plan of Care” last reviewed July 2023 revealed the following: - “The facility’s interdisciplinary team consists of, at a minimum, the patient..., a registered nurse, a physician or non-physician practitioner..., a social worker, and a dietician.” - “The facility’s interdisciplinary team will develop and implement a written, individualized comprehensive plan of care that specifies the services necessary to address the patient’s needs...” - “The patient’s plan of care will be completed by facility’s interdisciplinary team, including the patient...and be signed by team members including the patient...” Review of Pt #4’s IDT POC meeting dated 05/02/2024 revealed that Pt #4 signed the POC on 05/08/2024 (6 days later) and Registered Nurse (RN) F signed the POC on 05/06/2024 (4 days later). There was no documented evidence that Pt #4 and RN F participated in the POC meeting on 05/02/2024. During an interview with Facility Administrator (FA) A on 05/08/2024 at 3:59 PM, while discussing medical record findings, FA A confirmed the findings and stated that the IDT should sign the POC at the time of the meeting as evidence of attendance. FA A did not know why RN F signed the POC 4 days later and was unable to confirm if RN F attended the meeting on 05/02/2024.”

“QAPI-MEASURE/ANALYZE/TRACK QUAL INDICATORS CFR(s): 494.110(a)(2) The dialysis facility must measure, analyze, and track quality indicators or other aspects of performance that the facility adopts or develops that reflect processes of care and facility operations. These performance components must influence or relate to the desired outcomes or be the outcomes themselves. This Standard is not met as evidenced by: 29972 Based on record review and interview facility staff failed to ensure that quality data is tracked and analyzed to address issues with Blood Pressure management, Mortality, Physical Plant safety, and Modality choice for 1 of 1 dialysis program quality data reviewed ( In-Center Hemodialysis), in a total sample of 1 dialysis program reviewed. Findings include: Review of policy #1-14-06 titled, “Continuous Quality Improvement Program” last revised 4/2021 revealed the following: -Written documentation and plans of action will be documented within the FHM (Facility Health Meeting) application known as Facility Health Record (FHR)...Copies of the QI (Quality Improvement) meeting minutes will be provided upon request to CMS (Centers for Medicare and Medicaid). -The facility will measure, analyze, and track quality indicators or other aspects of performance. Blood Pressure Management: Review of FHR Fluid management dashboard from February 2024, March 2024, and April 2024, revealed there was no documented evidence of the interdisciplinary team (IDT) tracking, analyzing, and addressing issues with Blood Pressure management in FHM. Mortality Review: Review of facility Mortality Review Forms revealed the following: Pt #10: Date of Death 03/22/2024; Primary Cause of Death is Cardiac Arrest. Pt #11: Date of Death 03/17/2024; Primary Cause of Death is Cardiac Arrest. Pt #12: Date of Death 01/05/2024: Primary Cause of Death is Cardiac Arrest. Pt #13: Date of Death 01/10/2024: Primary Cause of Death is Cardiac Arrest. Review of FHR Mortality dashboard, revealed there was no documented evidence of the IDT analyzing for trends and addressing commonalities related to patient deaths in the FHM conducted in February 2024 (2 deaths in January) and April 2024 (2 deaths in March). Physical Plant safety audits: Review of FHR dashboard from March 2024 and April 2023, revealed there was no documented evidence of the IDT tracking, analyzing, and addressing issues with the Physical Plant safety audits. Review of the Occupational Safety and Health Administration (OSHA) audits conducted monthly revealed there were no audits completed for the month of February 2024 and March 2024. Modality Choice: Review of FHR dashboard from February 2024, March 2024, and April 2023, revealed there was no documented evidence of the IDT tracking, analyzing, and addressing issues in Modality choice/referrals in FHM. Per interview with Manager of Clinical Services (MCS) B and Facility Administrator (FA) A on 05/08/2024 during FHR review between 1:45 PM and 3:45 PM, MCS B confirmed the above findings and stated that staff should be addressing the above indicators in monthly FHM and documenting in the FHR. Per interview, MCS B confirmed that OSHA audits (Physical Plant audits) should be conducted monthly and discussed in FHM.”

“QAPI-INDICATOR-MEDICAL INJURIES/ERRORS CFR(s): 494.110(a)(2)(vi) The program must include, but not be limited to, the following: (vi) Medical injuries and medical errors identification. This Standard is not met as evidenced by: 29972 Based on record review and interview facility staff failed to recognize and address trends related to adverse events in 1 of 1 dialysis quality program reviewed (In-Center Hemodialysis), in a total of quality program reviewed. Findings include: Review of policy #1-14-06 titled, “Continuous Quality Improvement Program” last revised 4/2021 revealed the following: -Written documentation and plans of action will be documented within the FHM (Facility Health Meeting) application known as Facility Health Record (FHR)...Copies of the QI (Quality Improvement) meeting minutes will be provided upon request to CMS (Centers for Medicare and Medicaid). -The facility will measure, analyze, and track quality indicators or other aspects of performance. The program must include, but not limited to...Review of trends of adverse patient occurrences...Other indicators as reflected in the FHR application. -Continuous monitoring of the above indicators will be reflected in the meeting minutes. Review of FHR documentation for March 2024 revealed, “3 general dialysis access issues filed for the month of March 2024...infiltration x 2 (needle has been dislodged from inside the fistula or graft during needle insertion or during dialysis treatment) (able to dialyze) and...infiltration (unable to dialyze-rescheduled for the next day).” Review of FHR revealed there was no documented evidence that the Interdisciplinary team (IDT) analyzed and discussed trends in access infiltrations to mitigate potential reoccurrence. Per interview with Manager of Clinical Services (MCS) B and Facility Administrator (FA) A on 05/08/2024 during FHR review between 1:45 PM and 3:45 PM, MCS B confirmed the above findings and stated that there was no documented evidence that staff analyzed and addressed trends in adverse events in FHM.”

“QAPI-INDICATOR-INF CONT-TREND/PLAN/ACT CFR(s): 494.110(a)(2)(ix) The program must include, but not be limited to, the following: (ix) Infection control; with respect to this component the facility must- (A) Analyze and document the incidence of infection to identify trends and establish baseline information on infection incidence; (B) Develop recommendations and action plans to minimize infection transmission, promote immunization; and (C) Take actions to reduce future incidents. This Standard is not met as evidenced by: 29972 Based on record review and interview facility staff failed to ensure that quality data is tracked and analyzed to address issues with Infection Control for 1 of 1 dialysis program quality data reviewed (In-Center Hemodialysis), in a total sample of 1 dialysis program reviewed. Findings include: Review of policy #1-14-06 titled, “Continuous Quality Improvement Program” last revised 4/2021 revealed the following: - “Written documentation and plans of action will be documented within the FHM (Facility Health Meeting) application known as Facility Health Record (FHR)...Copies of the QI (Quality Improvement) meeting minutes will be provided upon request to CMS (Centers for Medicare and Medicaid).” - “The facility will measure, analyze, and track quality indicators or other aspects of performance. The program must include...Infection Control, including...Incidence of infections...” Review of Infection Control log from February 2024 revealed the following infections: -On 02/08/2024 Central Venous Catheter (CVC) infection -On 02/14/2024 Pneumonia infection Per review of the Infection Control log, the categories for “Antibiotic/Intervention”; “Culture results...”; and “Resolution Date” were blank for the both infections. Review of FHR dashboard from February 2024, March 2024, and April 2023, revealed there was no documented evidence of the Interdisciplinary Team (IDT) analyzing and trending issues related to Infection Control, including the Infection Control log and the Infection Control Audits. Per interview with Manager of Clinical Services (MCS) B and Facility Administrator (FA) A on 05/08/2024 during FHR review between 1:45 PM and 3:45 PM, MCS B and FA A confirmed the above findings. FA A stated that she/he was unable to provide documented evidence of the Infection Control Audits being completed for February 2024, March 2024, and April 2024. FA A stated that the Infection Control Audits should be completed monthly. MCS B stated that staff should complete all categories on the Infection Control Log, including; Antibiotic/Intervention, Culture results, and Resolution date.”