Davita New Bedford Dialysis

“CFC-PATIENT ASSESSMENT CFR(s): 494.80 This Condition is not met as evidenced by: 10249 Based on medical record reviews, staff interviews, review of facility documentation, and policy review, the facility failed to be in compliance with the Condition of Patient Assessment (42 CFR 494.80) for 4 of 9 applicable patients (#1, #5, #10, and #11), out of a total sample of 11 patients. Findings include: 1. The facility failed to ensure the interdisciplinary team (IDT) completed an initial Comprehensive Assessment within 30 calendar days or 13 hemodialysis sessions beginning with the first dialysis session for 2 of 9 applicable patients (#1, #10), out of a total sample of 11 patients. Please refer to V-0516. 2. The facility failed to ensure an unstable comprehensive re-assessment and revision of plan of care was conducted for 2 of 9 applicable patients (#5, #11), out of a total sample of 11 patients, after an extended hospitalization stay greater than 15 days and inadequate dialysis. Please refer to V-0520.”

“CFC-PATIENT PLAN OF CARE CFR(s): 494.90 This Condition is not met as evidenced by: 10249 Based on staff interview, clinical record review, and policy review, the facility failed to be in compliance with the Condition of Patient Plan of Care (42 CFR 494.90) for 7 of 9 applicable patients (#1, #3, #4, #5, #7, #10, and #11), out of a total sample of 11 patients. Findings include: 1. The facility failed the ensure the Interdisciplinary Team (IDT) developed and implemented a written, individualized comprehensive plans of care that specified the services necessary to address patient needs, including measurable and expected outcomes with estimated timetables to achieve the outcomes for 4 of 9 applicable patients (#1, #5, #10, and #11), out of a total sample of 11 patients. Please refer to V-0541. 2. The facility failed to ensure that staff delivered the treatment as prescribed relative to the Blood Flow Rate (BFR-speed measured in millimeters per minute {ml/min} in which the patient’s blood is pushed through the dialyzer and back into the body) for 1 of 7 applicable patient (#11), out of a total sample of 11 patients. Please refer to V-0544 3. The facility failed to complete necessary psychosocial status monitoring by failing to complete standardized mental and physical assessment tool (KDQOL-36) chosen by the Social Worker (SW) within four months of initiating treatment (or first reassessment) and at least annually, at regular intervals for 3 of 9 applicable patients (#3, #4, and #7), out of a total sample of 11 patients. Please refer to V-0552 4. The facility failed to 1.) schedule a care plan meeting; and 2.) ensure the care plan was signed by 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, to ensure the patient had involvement with his/her plan of care for 4 of 9 applicable patients (#1, #5, #10, #11), from a total sample of 11 patients. Please refer to V-0556”

“CFC-QAPI CFR(s): 494.110 This Condition is not met as evidenced by: 10249 Based on interview, policy review, review of facility grievance log, and review of the facility’s Quality Assurance and Performance Improvement (QAPI) program, the facility failed to be in compliance with the Condition of Quality Assessment Performance Improvement (42 CFR 494.110) to ensure patient safety and improve care. Findings include: 1. The facility failed to 1.) ensure the facility grievance process was followed with a documented resolution to a patient’s grievance; and 2.) failed to implement an opportunity for improvement for the patient’s grievance process and patient care. Please refer to V-0636 2. The facility failed to ensure that 1.) comprehensive assessments, care plans, and psychosocial assessments (KDQOL-36) were being tracked, trended, and monitored for completeness, and 2.) develop and implement action plans that resulted in performance improvements that were sustained overtime. Please refer to V-0638”

“IC-CLEAN/DIRTY;MED PREP AREA;NO COMMON CARTS CFR(s): 494.30(a)(1)(i) Clean areas should be clearly designated for the preparation, handling and storage of medications and unused supplies and equipment. Clean areas should be clearly separated from contaminated areas where used supplies and equipment are handled. Do not handle and store medications or clean supplies in the same or an adjacent area to that where used equipment or blood samples are handled. When multiple dose medication vials are used (including vials containing diluents), prepare individual patient doses in a clean (centralized) area away from dialysis stations and deliver separately to each patient. Do not carry multiple dose medication vials from station to station. Do not use common medication carts to deliver medications to patients. If trays are used to deliver medications to individual patients, they must be cleaned between patients. This Standard is not met as evidenced by: 44223 Based on observation, staff interview, and review of the Centers for Disease Control (CDC) Infection Control Requirements for Dialysis Facilities, the facility failed to 1.) ensure there was separation of clean and contaminated items on the dialysis unit, and 2.) ensure 2 of 2 staff members (Registered Nurse [RN] #3, and RN #4) observed, removed potentially contaminated personal protective equipment (PPE) before entering the med prep area and preparing patient intravenous medication. Findings Include: 1. The facility failed to ensure that proper infection control practices were followed when personal protective equipment (PPE) came in contact with both “clean” and “dirty” areas. A. On 6/4/24 at 8:50 A.M., during an observation of the treatment area, the surveyor observed two hooks on the wall next to the door leading to the water treatment room. PPE was observed on the hooks including two gowns and two faceshields. The gowns were observed to be overlapping each other on one hook, while the two faceshields were overlapping each other on the other hook, causing potential concern for cross contamination. On 6/4/24 at 10:45 A.M., the surveyor observed one hook on the exit door leading to the facility lobby, and one hook on the entrance door to the treatment floor. Each hook was observed to have a gown hanging from it. The surveyor observed patients entering and exiting the treatment floor from these doors, potentially coming into contact with the gowns that were hung on the doors. On 6/5/24 at 11:30 A.M., the surveyor observed three hooks on the wall next to the door leading onto the treatment floor from the employee area. There were gowns hanging on all three hooks. All the gowns were overlapping each other. On 6/5/24 at 12:29 P.M., the surveyor entered the treatment area and went to retrieve their gown and faceshield. The gown and faceshield were covered by a staff member’s gown. During an interview on 6/5/24 at 12:30 P.M., the Manager of Clinical Services said we need more hooks, and that should not be like that. 10249 B. On 6/4/24 at 9:32 A.M., the surveyor observed Patient #9 as they had just completed their dialysis treatment. Patient #9 was observed leaving the dialysis station, walked over to the clean sink (adjacent to the floor scale), placed his/her personal duffle bag on the counter of the clean sink, then walked over to the floor scale and weighed him/herself. Patient #9 then retrieved the bag from the counter and exited the clinic. *On 6/4/24 at 9:50 A.M., the surveyor observed Patient #10 as they had just completed their dialysis treatment. Patient #10 was observed leaving the dialysis station, walked over to the clean sink (adjacent to the floor scale), placed his/her personal belonging/bag on the counter of the clean sink, then walked over to the floor scale and weighed him/herself. Patient #10 then retrieved their belongings from the counter and exited the clinic. During an interview on 6/5/24 at 12:29 P.M., the Manager of Clinical Services said the patients should not be putting their bags or personal belongings on the counter of the clean sink, before weighing themselves. 2. Review of the Centers for Disease Control (CDC) Infection Control Requirements for Dialysis Facilities and Clarification Regarding Guidance on Parenteral Medication Vials, dated 8/15/08, included the following: *CDC recommends that all parenteral medications should be prepared in a clean area separate from potentially contaminated items and surfaces. In hemodialysis settings where environmental surfaces and medical supplies are subjected to frequent blood contamination, medication preparation should occur in a clean area removed from the patient treatment area. Proper infection control practices must be followed during the preparation and administration of injected medications. This is consistent with official CDC recommendations for infection control precautions in hemodialysis. On 6/5/24 at 8:00 A.M., during observation of the medication preparation and administration task, the surveyor observed RN #3 enter the medication preparation area wearing a gown that had been worn in and out of patient dialysis stations to care for patients. At no time did RN #3 remove their gown prior to entering the medication preparation area. He prepared the medication sodium thiosulfate (for calciphylaxis) 25 milligrams (mg), left the medication area with his gown still on, then entered station #5 wearing the same gown to administer the medication. On 6/5/24 at 8:30 A.M., during observation of medication preparation and administration task, the surveyor observed RN #4 enter the medication preparation area wearing a gown that had been worn in and out of patient dialysis stations to care for patients. At no time did RN #4 remove their gown prior to entering the medication preparation area. She prepared the medication Venofer (treatment for chronic kidney disease patients experiencing iron deficiency), left the medication preparation area with her gown still on, then entered station #15 wearing the same gown to administer the medication. During an interview on 6/5/24 at 9:00 A.M., the Manager of Clinical Services said she considers the medication preparation area as a clean area.”

“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: 38141 Based on observation, interview, and policy review, the facility failed to ensure that 1 of 2 staff members (Certified Clinical Hemodialysis Technician [CCHT] #4) observed, failed to provide adequate infection control measures during initiation of treatment with a Central Venous Catheter (CVC). Findings include: Review of the facility policy, Central Venous Catheter with Clear guard HD Antimicrobial End Caps Procedure, revised October 2023, included 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. * 70% alcohol CVC Hubs 15 second scrub. * Remove syringes and disinfect the CVC hubs with new alcohol prep pad for each CVC hub. Scrub the sides, threads and end of hub thoroughly with friction for 15 seconds, making sure to remove any residue, for example blood. Hold the catheter until the antiseptic has dried. On 11/15/23 at 11:15 A.M., the surveyor observed CCHT #4 initiate treatment for Patient #8 in station 9. The surveyor observed CCHT #4 prepare Patient #8 for treatment initiation by providing him/her with a face mask, and placed all the supplies on the tray table. CCHT #4 provided CVC exit site care and then proceeded to disinfect the CVC hubs. She opened an alcohol prep pad and disinfected the arterial hub of the CVC for 8 seconds. CCHT # 4 then opened another alcohol prep pad and disinfected the venous hub for 8 seconds. She did not disinfect the 2 CVC hubs for 15 seconds each, per facility policy. During an interview on 6/4/24 at 11:40 A.M., CCHT #4 said that she will check the facility policy, but she usually disinfects the CVC hub for 5 to 10 seconds.”

“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: 44223 Based on observation, and staff interview, the facility failed to provide dialysis patients and staff a functional and comfortable treatment environment. Findings Include: On 6/4/24 at 8:00 A.M., during the initial tour of the water treatment room, the surveyor observed the following: *The water treatment room floor was cement and gray in color. In areas the floor was noted to be cracked and broken with missing pieces. These missing pieces caused divots in the flooring causing potential risk for tripping. *In the area where the acid tanks are located, the floor had broken and cracked areas, one area with missing pieces causing a divot in front of a storage cabinet. *To the right of the entrance door to the water treatment room were five intravenous (IV) poles. All the IV poles had rusted areas on them, including large areas of rust on the base of the poles. *Along the wall where extra acid containers are stored, there were four large holes (approximately 6 inches by 6 inches) along the bottom of the wall, with debris on the floor behind the acid containers. *There was broken and cracked flooring causing a small divot in front of the exit/delivery door. *There was broken and cracked flooring in front of the acid containers, that were stored in the middle of the room, and on the right side of the room. During an interview on 6/5/24 at 11:30 A.M., the Regional Biomed Operational Manager said the facility was aware of the broken flooring and holes in the wall and had submitted a work order with the company to have the areas fixed. Review of work order indicated the request was reported on 4/19/24 at 12:26 P.M., with a start date of 4/24/24. The work order had a target date of 5/22/24. As of 6/6/24 there was no estimated date when the flooring or walls would be fixed.”

“PA-FREQUENCY-INITIAL-30 DAYS/13 TX CFR(s): 494.80(b)(1) An initial comprehensive assessment must be conducted on all new patients (that is, all admissions to a dialysis facility), within the latter of 30 calendar days or 13 hemodialysis sessions beginning with the first dialysis session. This Standard is not met as evidenced by: 38141 Based on record review, interview, and policy review, the facility failed to ensure the interdisciplinary team (IDT) of the facility completed an initial comprehensive assessment within 30 calendar days or 13 hemodialysis sessions beginning with the first dialysis session. for 2 of 9 applicable patients (#1, #10), out of a total sample of 11 patients. Findings include: Review of the facility policy titled, Interdisciplinary Team (IDT) Patient and Plan of Care, revised July 2023, included the following: * The facility’s interdisciplinary team (IDT) consists of, at a minimum, the patient or the patient’s personal representative, a registered nurse, a physician or non-physician practitioner (NPP), if allowed by state ESRD licensure regulations, 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 documenting his/her needs. The comprehensive assessment will be used to develop the patient’s treatment plan and expectations for care. * A comprehensive assessment will be conducted on all new patients within 30 calendar days (or 13 outpatient dialysis sessions for hemodialysis) beginning with the first outpatient dialysis treatment or per state guidelines. * Assessment and Plans of Care for patients transferring in: If the comprehensive patient assessment and plan of care for experienced dialysis patient transferring from one facility to another is received with the patient in transfer and was completed by IDT in the last year, the IDT will review the PA/POC to determine that the documents reflect the patient’s status and needs. If the documents are inadequate or if the patient is determined to be unstable, the patient would be assessed within the usual 30 days. If the documents are adequate and the patient is stable, the IDT may conduct a reassessment within 3 months of admission. 1. For Patient #1, the IDT failed to complete an individualized comprehensive assessment as required, within 30 days or 13 treatments. Patient #1 was admitted to the facility in March 2024 with a diagnosis of acute kidney injury, requiring dialysis. Review of the clinical record indicated that Patient #1 was transferred from another facility and the comprehensive assessment was incomplete as of 6/4/24. During an interview on 6/5/24 at 1:10 P.M., the Facility Administrator said Patient #1 is a transfer from another facility. He said that Patient #1 initial comprehensive assessment was not completed because he/she was not assessed by the social worker, who was out on leave. 2. For Patient #10, the IDT failed to complete an individualized comprehensive assessment as required, within 30 days or 13 treatments. Patient #10 was admitted to the facility in February 2024 with a diagnosis of acute kidney injury, requiring dialysis. Review of the clinical record indicated that as of 6/6/24, the comprehensive assessment was incomplete for Patient #10. During an interview on 6/6/24 at 1:30 P.M., the Clinical Coordinator said that Patient #10 should have had an initial assessment since admission. She said that Patient #10 had not been assessed by a social worker and they could not generate a plan of care. She said that the facility social worker is on leave as of the end of January 2024.”

“PA-FREQUENCY REASSESSMENT-UNSTABLE Q MO CFR(s): 494.80(d)(2) In accordance with the standards specified in paragraphs (a)(1) through (a)(13) of this section, a comprehensive reassessment of each patient and a revision of the plan of care must be conducted- At least monthly for unstable patients including, but not limited to, patients with the following: (i) Extended or frequent hospitalizations; (ii) Marked deterioration in health status; (iii) Significant change in psychosocial needs; or (iv) Concurrent poor nutritional status, unmanaged anemia and inadequate dialysis. This Standard is not met as evidenced by: 44223 Based on record review, interview, and policy review, the facility failed to ensure an unstable comprehensive re-assessment and revision of plan of care was conducted for 2 of 9 applicable patients (#5, #11), out of a total sample of 11 patients, after an extended hospitalization stay greater than 15 days and inadequate dialysis. Findings Include: Review of the facility policy titled, Interdisciplinary Team (IDT) Patient Assessment and Plan of Care, dated July 2023, indicated the following: *Purpose: To provide guidance for the development of patient assessment and plan of care for IDT teammates. *A comprehensive re-assessment of each patient and a revision in the plan of care will be conducted: *At least annually for stable patients and semiannually when required by State Regulation. *At least monthly for unstable patients, including, but not limited to, patients with the following: *Extended or frequent hospitalizations. *Marked deterioration in health status. *Significant changes in psychosocial needs. *Concurrent poor nutritional status, unmanaged anemia, and inadequate dialysis. *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, as identified by the comprehensive assessment and changes in the patient’s condition, and will include measurable and expected outcomes and estimated timetables to achieve these outcomes. The outcomes specified in the patient plan of care will be consistent with current evidence-based professionally-accepted clinical practice standards. 1. For Patient #11, the facility failed to ensure an unstable comprehensive re-assessment and revision of plan of care was conducted. Patient #11 was admitted to the facility in May 2023 with a diagnosis of End Stage Renal Disease, requiring dialysis. Review of the clinical record indicated Patient #11 had been hospitalized from 3/12/24-3/24/24 for cardiac surgery, then again on 3/27/24-4/12/24 (totaling 29 days) for ongoing bleeding which required surgery. Further review of the clinical record indicated the IDT failed to identify Patient #11 as an unstable patient, per their facility policy. Review of the facility’s list of unstable patients indicated Patient #11 was not documented as unstable. During an interview on 6/6/24 at 11:30 A.M., the Facility Administrator (FA) and the Clinical Coordinator (CC) both said the Patient probably should of been documented as unstable due to his/her two extended hospitalizations. They said that a comprehensive re-assessment and revision of a plan of care should of been completed. 10249 2. Patient #5 was admitted to the facility in February 2019 with a diagnosis of End Stage Renal Disease, requiring dialysis. Review of the clinical record indicated that Patient #5 had a comprehensive assessment completed in 1/19/24, with a plan of care developed based on that assessment. At that time the IDT meeting determined that Patient #5 was deemed medically unstable and would be re-assessed in 30 days. Further review of the clinical record indicated that the social worker assessment had not been conducted, therefore the patient’s plan of care could not be revised. During an interview on 6/5/24 at 2:45 P.M., the Registered Dietitian (RD) said the patient was determined to be unstable in January 2024, due to frequent hospitalizations and missed treatments. The RD said the unstable assessments were due on 2/18/24, but even though she and the nurse had completed their part of the comprehensive assessment for Patient #5, the care plan could not be developed until after the social worker had completed the comprehensive assessment. The RD said the facility social worker is out on leave and there has been no social service coverage since the end of January 2024.”

“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: 44223 Based on clinical record review, policy review, and staff interview, facility failed the ensure the Interdisciplinary Team (IDT) developed and implemented a written, individualized comprehensive plans of care that specified the services necessary to address patient needs, including measurable and expected outcomes with estimated timetables to achieve the outcomes for 4 of 9 applicable patients (#1, #5, #10, and #11), out of a total sample of 11 patients. Findings include: Review of the facility policy titled, Interdisciplinary Team (IDT) Patient Assessment and Plan of Care, dated July 2023, indicated the following: * To provide guidance for the development of patient assessment and plan of care for IDT teammates. *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, as identified by the comprehensive assessment and changes in the patient’s condition, and will include measurable and expected outcomes and estimated timetables to achieve these outcomes. The outcomes specified in the patient plan of care will be consistent with current evidence-based professionally-accepted clinical practice standards. *An initial Plan of Care, based on the findings from the comprehensive assessment, will be completed on all patients new to dialysis within 30 calendar days (or 13 outpatient dialysis sessions for hemodialysis) beginning within the first outpatient dialysis treatment or per state guidelines. *After completion of the 90 day re-assessment, the Interdisciplinary Team will conduct an IDT meeting to make adjustments to the Plan of Care. This meeting and initiation of the updated Plan of Care must occur within 15 days of completion of re-assessment. *Subsequent interdisciplinary re-assessments should be completed within 30 days following the initiation of the reassessment. The Plan of Care following re-assessments must be completed 15 days of completing the re-assessment. This process would occur monthly for unstable patients and annually for stable patients. 1. For Patient #11, the facility failed to ensure the IDT developed and implemented an individualized plan of care with expected outcomes, interventions, and estimated timetables to achieve the outcomes to address the patient’s needs after an extended hospitalization. Patient #11 was admitted to the facility in May 2023 with a diagnosis of End Stage Renal Disease, requiring dialysis. Review of the clinical record indicated the patient had extended hospitalizations from 3/12/24-3/24/24 for cardiac surgery and from 3/27/24-4/12/24 (for a total of 29 days) for ongoing bleeding requiring surgery. Review of the clinical notes indicated Patient #11 returned to the facility and resumed dialysis treatments on 4/15/24. Further review of the clinical record indicated the IDT did not complete a comprehensive re-assessment and failed to identify the patient as an unstable patient due to extended hospitalizations, therefore not developing and implementing a revision of the plan of care. During an interview on 6/6/24 at 11:30 A.M., the Facility Administrator (FA) and the Clinical Coordinator (CC) both said that the patient was reviewed at the Core Team meeting but the IDT did not complete a comprehensive re-assessment or implement a revision of the plan of care. 38141 2. For Patient #1, the facility failed to ensure the IDT developed and implemented an individualized plan of care with expected outcomes, interventions, and estimated timetables to achieve the outcomes to address the patient’s needs. Patient #1 was admitted to the facility in March 2024 with a diagnosis of acute kidney injury, requiring dialysis. Review of the clinical record indicated that Patient #1 was transferred from another facility and as of 6/4/24, no initial comprehensive assessment and plan of care had been completed by the IDT. During an interview on 6/5/24 at 1:10 P.M., the Facility Administrator said Patient #1 is a transfer from another facility. He said that Patient #1’s initial comprehensive assessment and plan of care was not completed because he/she was not assessed by a social worker, who was out on leave. 3. For Patient #10 the facility failed to ensure the IDT developed and implemented an individualized plan of care with expected outcomes, interventions, and estimated timetables to achieve the outcomes to address the patient’s needs. Patient #10 was admitted to the facility in February 2024 with a diagnosis of acute kidney injury, requiring dialysis. Review of the clinical record indicated that as of 6/6/24, no initial comprehensive assessment and plan of care had been completed by the IDT. During an interview on 6/6/24 at 1:30 P.M., the Clinical Coordinator said that Patient #10 should have an initial assessment and plan of care since admission, but his/her assessment had not been completed because Patient #10 was not assessed by a social worker and they cannot generate a complete assessment and POC if it’s not completed by the entire IDT. She said that the facility social worker is on leave as of end of January 2024. 10249 4. For Patient #5 the facility failed to ensure the IDT developed and implemented an individualized plan of care with expected outcomes, interventions, and estimated timetables to achieve the outcomes to address the patient’s needs after an extended hospitalization. Patient #5 was admitted to the facility in May 2023 with a diagnosis of End Stage Renal Disease, requiring dialysis. Review of Patient #5’s care plan, dated 1/24/24, indicated the IDT deemed the patient’s medical status as unstable and would reassess the patient in 30 days, per facility policy. Further review of the clinical record indicated that the social worker assessment had not been conducted, therefore the patient’s plan of care could not be developed. During an interview on 6/5/24 at 2:45 P.M., the Registered Dietitian (RD) said the patient was determined to be unstable in January 2024, due to frequent hospitalizations and missed treatments. The RD said the unstable assessments were due on 2/18/24, but even though she and the nurse had completed their part of the comprehensive assessment for Patient #5, the care plan could not be developed until after the social worker had completed her part of the comprehensive assessment. The RD said the computer program does not allow us to develop a care plan if there are missing assessments. The RD said the facility social worker is out on leave and there has been no social service coverage since the end of January 2024.”

“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: 44223 Based on record review and interview, the facility failed to ensure that staff delivered the treatment as prescribed relative to the Blood Flow Rate (BFR-speed measured in millimeters per minute {ml/min} in which the patient’s blood is pushed through the dialyzer and back into the body) for 1 of 7 applicable patient (#11), out of a total sample of 11 patients. Findings Include: Patient #11 was admitted to the facility in May 2023 with a diagnosis of End Stage Renal Disease requiring dialysis. Review of the Physician’s order, dated 5/14/24, indicated the BFR was to be delivered at a rate of 400 ml/min. Review of 9 dialysis treatment flowsheets, dated 5/15/24-6/5/24, indicated the BFR had not been delivered as prescribed for 3 of 9 treatments, including the following: *5/15/24-the BFR was delivered at a rate of 200 ml/min not the 400 ml/min as ordered and there was no documentation to indicate why the physician’s order was not followed. *5/22/24-the BFR was delivered at a rate of 350 ml/min not the 400 ml/min as ordered and there was no documentation to indicate why the physician’s order was not followed. *6/5/24-the BFR was delivered at a rate of 340 ml/min not the 400 ml/min as ordered and there was no documentation to indicate why the physician’s order was not followed. During an interview on 6/6/24 at 2:30 P.M., the Manager of Clinical Services said if there is a change in the BFR then the reason should be documented on the treatment sheet, and the nurse should be notified.”

“POC-P/S COUNSELING/REFERRALS/HRQOL TOOL CFR(s): 494.90(a)(6) The interdisciplinary team must provide the necessary monitoring and social work interventions. These include counseling services and referrals for other social services, to assist the patient in achieving and sustaining an appropriate psychosocial status as measured by a standardized mental and physical assessment tool chosen by the social worker, at regular intervals, or more frequently on an as-needed basis. This Standard is not met as evidenced by: 38141 Based on record review, policy review, and staff interview, the facility failed to complete necessary psychosocial status monitoring by failing to complete standardized mental and physical assessment tool (KDQOL-36) chosen by the Social Worker (SW) within four months of initiating treatment (or first reassessment) and at least annually, at regular intervals for 3 of 9 applicable patients (#3, #4, and #7), out of a total sample of 11 patients. Findings include: Review of the facility policy titled “Quality of Life Assessment Survey”, with a revision date of October 2023, indicated the following: * The Quality of Life (QOL) assessment survey is to be administered by the Social Worker to patients within four months of initiating treatment, on an as needed basis, and repeated at least annually. Examples of as needed basis would include repeating use of the survey with patients who have a significant life changing events (e.g. loss of spouse, loss of job, recent move to a nursing home or a change in health status). * If patients refuse to complete the KDQOL-36 at any time, the social worker needs to document the refusal in the KDQOL psychosocial condition in the electronic medical record. * The KDQOL patient results report is to be reviewed by the social worker with the patient within 30 days of completing the survey. The completed survey and results should be maintained in the patient’s medical record. 1. For Patient #7, the facility failed to ensure the KDQOL-36, had been completed at least annually. Patient #7 was admitted to the facility in March 2023 with a diagnosis of acute kidney injury, requiring dialysis. Review of the clinical record and 90 day comprehensive assessment dated 1/17/24, failed to indicate if Patient #7 had completed or refused to complete the KDQOL assessment survey. During an interview on 6/5/24 at 11:40 A.M., Peritoneal Dialysis (PD) Nurse said that the social worker was on extended leave and that she was not sure if she had completed the KDQOL assessment survey for Patient #7. PD Nurse also said that she reviewed Patient #7’s clinical record and she could not locate a KDQOL assessment survey. 44223 2. For Patient #4, the facility failed to ensure the KDQOL-36 had been completed at least annually. Patient #4 was admitted to the facility in December 2021 with a diagnosis of End Stage Renal Disease, requiring dialysis. Review of the clinical record indicated an annual comprehensive assessment was completed in October 2023. The comprehensive assessment indicated that a KDQOL-36 was not completed due to cognitive impairment, dementia, or active psychosis. Further review of the clinical record indicated that Patient #4 did not have an active diagnosis of dementia, psychosis, or cognitive impairment. Documentation in the clinical record indicated the patient is alert and orientated and able to make all needs known. Review of the Care Activities form, which indicates what assessments are due to be completed, indicated that Patient #4’s KDQOL-36 due date was changed to 5/21/24 because the Social Worker was out on leave. Further review of the clinical record failed to indicate if the patient had been asked to complete the KDQOL-36, or if he/she had refused to complete it. During an interview on 6/5/24 at 2:40 P.M., the Clinical Coordinator (CC) said Patient #4 is alert and oriented, but is very hard of hearing, and requires a communication board to communicate with staff. She said that Patient #4 can complete the required paperwork, indicating the patient could complete a KDQOL-36. During an interview on 6/6/24 at 3:00 P.M., the Manager of Clinical Services said all documentation she found in the clinical record indicates the patient is alert and oriented, and can make his/he needs known. 10249 3. For Patient #3, the facility failed to ensure that the KDQOL-36, had been completed at least annually. Patient #3 was admitted to the facility in March 2023 with a diagnosis of End Stage Renal Disease, requiring hemodialysis. Review of the 90 day comprehensive assessment, dated 1/5/24, indicated that the social worker had completed a comprehensive psychosocial assessment on 1/3/24 which indicated that the KDQOL data was not available. Review of the clinical record indicated that a depression screen was completed, however there was no evidence that the patient was given and/or completed the KDQOL-36 survey. During an interview on 6/5/24 at 2:30 P.M., the Facility Administrator said he was unable to locate a KDQOL for Patient #3.”

“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: 10249 Based on record review, interview, and policy review, the facility failed to 1.) schedule a care plan meeting; and 2.) ensure the care plan was signed by 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, to ensure the patient had involvement with his/her plan of care for 4 of 9 applicable patients (#1, #5, #10, #11), from a total sample of 11 patients. Findings include: Review of the facility policy titled, Interdisciplinary Team (IDT) Patient Assessment and Plan of Care, revised July 2023, included the following, but not limited to: *The facility’s IDT consists of, at a minimum, the patient or patient’s personal representative, a registered nurse, a physician or non-physician Practitioner (NPP), if allowed by state ESRD licensed regulations, treating the patient for ESRD, a social worker, and a dietitian. *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, as identified by the comprehensive assessment ad changes in the patient’s condition, and will include measurable and expected outcomes and estimated timetables to achieve these outcomes. The outcomes specified in the patient plan of care will be consistent with current evidence-based professionally-accepted clinical practice standards. *After completion of the 90-day re-assessment, the IDT will conduct an IDT meeting to make adjustments to the plan of care. This meeting and initiation of the updated plan of care must occur within 15 days of the completed reassessment. *60 days external transfer-complete patient’s plan of care meeting within 15 days of the completion of the assessment. *Monthly unstable patients-complete patient’s plan of care meeting within 15 days. *Annual patient review-complete patient’s plan of care meeting within 15 days. *Subsequent IDT re-assessments should be completed within the 30 days following the initiation of the re-assessment. The plan of care following re-assessments must be completed within 15 days of the completed reassessment. The process would occur monthly for unstable patients ad annually for stable patients. *The patient’s plan of care will be completed by the facility’s IDT, including patient or personal representative and be signed by the team members including the patient or the patient’s personal representative. If the patient chooses not to sign the plan of care, this choice will be documented on the plan of care, along with the reason the signature was not provided. 1. For Patient #5, the facility failed to ensure that a care plan meeting was held and the patient had the opportunity to sign the plan of care, based on the discussion with the IDT. Patient #5 was admitted to the facility in May 2023 with a diagnosis of End Stage Renal Disease, requiring dialysis. Review of the clinical record indicated that the patient was deemed medically unstable and a new assessment and care plan was due 2/18/24. Further review of the clinical record indicated that a care plan was not developed, nor was a care plan meeting held within the appropriate time frame for the patient to review and sign the care plan. During an interview on 6/5/24 at 2:45 P.M., the Registered Dietitian (RD) said the patient was determined to be unstable in January 2024, due to frequent hospitalizations and missed treatments. The RD said the unstable assessments was due on 2/18/24, but even though she and the nurse had completed their part of the comprehensive assessment for Patient #5, the care plan could not be developed until after the social worker had completed her part of the comprehensive assessment. The RD said the computer program does not allow us to develop a care plan if there is a missing assessment. The RD said the facility social worker is out on leave and there has been no social service coverage since the end of January 2024. She also said there has been no care plan meeting held since February 2024. During an interview on 6/6/24 at 11:00 A.M., the Medical Director said that his usual practice is to put aside time on Wednesdays for care plan meeting, however since February 2024 there have been no patient care plan meetings. 44223 2. For Patient #11 the facility failed to ensure that a care plan meeting was held and the patient had the opportunity to sign the plan of care, based on the discussion with the IDT. Patient #11 was admitted to the facility in May 2023 with a diagnosis of End Stage Renal Disease requiring dialysis. Review of the clinical record indicated the patient had extended hospitalizations from 3/12/24-3/24/24 for cardiac surgery and 3/27/24-4/12/24 (total of 29 days) for bleeding requiring surgery. Patient #11 returned to the facility on 4/15/24 to resume dialysis treatments. Further review identified the facility failed to identify the patient as unstable and did not complete a comprehensive re-assessment and develop a plan of care, nor was a care plan meeting held within the appropriate time frame for the patient to review and sign the care plan. During an interview on 6/6/24 at 11:30 A.M., the Facility Administrator (FA) and the Clinical Coordinator (CC) said that the patient had been reviewed at the facility Core Meeting but that a care plan was not developed or discussed with the patient. 38141 3. For Patient #1, the facility failed to ensure that a care plan meeting was held, and the patient had the opportunity to sign the plan of care based on the discussion with the IDT. Patient #1 was admitted to the facility in March 2024 with a diagnosis of acute kidney injury requiring dialysis. Review of the clinical record indicated that Patient #1 was transferred from another facility and that as of 6/4/23, no initial comprehensive assessment and plan of care had been completed by the IDT, nor was a care plan meeting held within the appropriate time frame for the patient to review and sign the plan of care. During an interview on 6/6/24 at 11:00 A.M., the Medical Director said that his usual practice is to put aside time on Wednesdays for care plan meeting, however since February 2024 there have been no patient care plan meetings. 4. For Patient #10, the facility failed to ensure that a care plan meeting was held, and the patient had the opportunity to sign the plan of care based on the discussion with the IDT. Patient #10 was admitted to the facility in February 2024 with a diagnosis of acute kidney injury requiring dialysis. Review of the clinical record indicated that as of 6/6/24, no initial comprehensive assessment and plan of care had been completed by the IDT, nor was a care plan meeting held within the appropriate time frame for the patient to review and sign the plan of care. During an interview on 6/6/24 at 11:00 A.M., the Medical Director said that his usual practice is to put aside time on Wednesdays for care plan meeting, however since February 2024 there have been no patient care plan meetings.”

“QAPI-INDICATOR-PT SATIS & GRIEVANCES CFR(s): 494.110(a)(2)(viii) The program must include, but not be limited to, the following: (viii) Patient satisfaction and grievances. This Standard is not met as evidenced by: 10249 Based on interview, policy review, Quality Assessment and Performance Improvement (QAPI) review of Patient Grievance Reports, the facility failed to 1.) ensure the facility grievance process was followed with a documented resolution to a patient’s grievance; and 2.) failed to implement an opportunity for improvement for the patient’s grievance process and patient care. Findings include: Review of the facility policy titled, Addressing Patient Grievances: Davita Teammates, revised October 2021, included the following but not limited to: *Grievances may be verbal or written. They may be submitted directly to a facility teammate or submitted to the DaVita Guest Services department. *All complaints/grievances should be documented on the facility Patient Grievance Log. *All details of the patient grievances and discussion will be documented. This documentation will be maintained in a separate file and kept in a secure and locked location. The Grievance Investigation Document may be used for this purpose. This form is not for patient use. Grievance documentation is not part of the patient medical record and should be provided to the patient. *Based on the nature of the complaint, the appropriate member of the interdisciplinary team (IDT) will discuss the grievance with the patient and take appropriate action towards the resolution, if possible. *If the patient grievance cannot be resolved, The Facility Administrator (FA) will be notified. The FA will meet with the patient to discuss the grievance and take appropriate resolution. If the grievance is not resolved, the patient should be invited to a grievance conference. The grievance conference should be coordinated to occur within 10 days of the receipt of the complaint. *The patient will be invited to participate in a formal Grievance Meeting attended by the FA, Social Worker (SW), Medical Director and the Regional Operations Director (ROD). The grievance meeting should occur within 10 days of initial receipt of the grievance. *Regional Operation Director and Medical Director will discuss the grievance with the patient and take appropriate action towards resolution. Record of the meeting should be documented during the meeting. *If the patient grievance cannot be resolved by the ROD and/or Medical Director, the Divisional Vice President will be notified. The Divisional VP will discuss the grievance with the patient and take appropriate action. *The Divisional VP issues a written, final decision to the patient within 10 days of the grievance conference. Review of the facility policy entitled, Continuous Quality Improvement Program, revised April 2021, indicated the following, but not limited to: *The facility will measure, analyze, and track quality indictors or other aspects of performance. The program must include, but not limited to the following: *Patient satisfaction and Grievances, including KDQOL *Continuous monitoring of the above indicator will be reflected in the meeting minutes. Any area identified as under performing will be reviewed to identify root causes for under performance, will have an action plan identified that will result in performance improvement, and will track this change in performance over time to verify improvements are sustained. Review of the Patient Grievance Log, dated April 3, 2023 through May 15, 2024, included 13 documented patient grievances. The Grievance Log indicated no documented evidence that the grievances were investigated and resolved for 10 of 13 patients. During an interview on 6/6/24 at 12:30 P.M., the Facility Administrator (FA) said he was unable to locate any further documentation pertaining to the identified grievances, other than the grievance log. He also said he could not speak to the grievances, since he became employed at the clinic in February 2024. The FA said he could not locate information in files or in the grievance binder that addressed the patient’s grievances. The FA said that the handwriting on the grievance log belonged to the social worker, who was currently on a leave, and unable to speak to the grievance process. The FA said that since he became the FA, they have not discussed grievances at the monthly QAPI meetings.”

“QAPI-MONITOR/ACT/TRACK/SUSTAIN IMPROVE CFR(s): 494.110(b) The dialysis facility must continuously monitor its performance, take actions that result in performance improvements, and track performance to ensure that improvements are sustained over time. This Standard is not met as evidenced by: 10249 Based on review of the Quality Assurance/Performance Improvement (QAPI) Program, staff interview, and policy review, the facility failed to ensure that 1.) comprehensive assessments, care plans, and psychosocial assessments (KDQOL-36) were being tracked, trended, and monitored for completeness, and 2.) develop and implement action plans that resulted in performance improvements that were sustained overtime. Findings include: Review of the facility policy entitled, Continuous Quality Improvement Program, revised April 2021, indicated the following, but not limited to: *Each Dialysis facility will have a Continuous Quality Improvement (CQI) Committee comprised of at least the following individuals from the interdisciplinary team: Medical Director, Facility Administrator, Registered Nurse, Biomed Technician, Registered Dietitian, and Social Worker. *The facility will measure, analyze, and track quality indictors or other aspects of performance. The program must include, but not limited to the following: *Patient satisfaction and Grievances, including KDQOL *Continuous monitoring of the above indicator will be reflected in the meeting minutes. Any area identified as under performing will be reviewed to identify root causes for under performance, will have an action plan identified that will result in performance improvement, and will track this change in performance over time to verify improvements are sustained. Review of the Facility Health Record (FHR)(QAPI) for assessments (and care plans) past due dated May 1, 2024 indicated an increase in overdue assessments from February 2024 (1%) to April 2024 (23%). *The identified root cause analysis (process deep dive): MSW was on maternity leave causing the assessments and plans of care to be past due. *The identified action plan/interventions: the FA and MSW to work together to gain process and clean up past due assessments and plans of care. *Evaluation plan: Team will look at it weekly in IDT to ensure process is on schedule. During an interview on 6/6/24 at 12:30 P.M., the FA said that although he does not have the May 2024 percentage of overdue assessments and care plans, but they were trending up. The FA said the facility social worker had been expected back in May 2024, but has extender her leave twice since 6/3/24. He said he did not have a new action plan to address the over due assessments. Review of the FHR minutes for KDQOL indicated that the IDT only monitored patient refusal rate. There was no evidence that the facility was monitoring late or incomplete KDQOL-36 patient surveys. During an interview on 6/6/24 at 12:30 P.M., the FA said that they were not monitoring this because the social worker was out on leave. He said they have not been offering the KDQOL-36 surveys to patients since it is the social worker’s responsibility.”

“PQ-STAFF LIC AS REQ/QUAL/DEMO COMPETENCY CFR(s): 494.140 All dialysis facility staff must meet the applicable scope of practice board and licensure requirements in effect in the State in which they are employed. The dialysis facility’s staff (employee or contractor) must meet the personnel qualifications and demonstrated competencies necessary to serve collectively the comprehensive needs of the patients. The dialysis facility’s staff must have the ability to demonstrate and sustain the skills needed to perform the specific duties of their positions. This Standard is not met as evidenced by: 38141 Based on personnel record review, and staff interview, the facility failed to ensure that water, dialysate, and machine training was assessed at least annually for 1 staff member (Certified Clinical Hemodialysis Technician (CCHT) #6), out of a total of 4 personnel records reviewed. Findings include: Review of the personnel record file indicated that CCHT #6 was hired on 5/26/20. Review of the Personal File Review form, submitted to the surveyor by the facility, indicated that CCHT #6 completed her annual water, dialysate, machine training on 5/1/24, but the Facility Administrator was unable to provide the surveyor proof/documentation of the training. During an interview on 6/6/24 at 2:15 P.M., the Facility Administrator said that he was unable to locate CCHT #6’s water, dialysate, machine annual training.”

“PQ-SW-MSW;GRANDFATHER IF HIRED BEFORE 1976 CFR(s): 494.140(d) The facility must have a social worker who- (1) Holds a master’s degree in social work with a specialization in clinical practice from a school of social work accredited by the Council on Social Work Education; or (2) Has served at least 2 years as a social worker, 1 year of which was in a dialysis unit or transplantation program prior to September 1, 1976, and has established a consultative relationship with a social worker who qualifies under §494.140 (d)(1). This Standard is not met as evidenced by: 10249 Based on record review and interview, the facility failed to ensure that social services from a licensed social worker were provided from February 1, 2024 through June 6, 2024. Findings include: During an interview on 6/5/24 at 11:30 A.M., The Regional Operational Manager said he was made aware that the social worker would be going out on leave in January 2024. He said he attempted to reach out to the corporate social worker to request support, but did not receive assistance. During an interview on 6/5/24 at 2:45 P.M., the Registered Dietitian said there were 39 assessments overdue because the social worker is on a leave, and there has been no social service coverage since February 2024. During an interview on 6/6/24 at 12:30 P.M., the Facility Administrator (FA) said that the facility social worker left for a planned leave on January 22, 2024, and a social worker from another clinic covered remotely until the end of January 2024. The FA said there has been no social worker coverage since February 2024. The FA said he was made aware of the social worker’s request for extension of her leave in April 2024, and just most recently 6/3/24. The FA said it was discussed at the Governing Body Meetings in April and June, but could not speak to any discussions prior to February 2024. The FA said there are 39 late patient assessments, and care plans. He also said the patients have not received their KDQOL surveys, nor have there been any care plan meeting since February 2024, due to the absence of a social worker.”

“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: 10249 Based on observation, interview, record review, and policy review, the Medical Director failed to ensure that staff adhered to the heparin administration policy and documented that they waited 3-5 minutes after administration of heparin (blood thinning medication) bolus to initiate the dialysis treatment for 3 of 7 applicable patients (#3, #5, and #11), from a total sample of 11 patients. Findings include: Review of the policy titled, AV{Arterio-Venous} Fistula or Graft Cannulation with Nipro or Medisystems Safety Fistula Needles and Administration of Heparin Loading Doses, revised October 2022, included the following but is not limited to: *Attached heparin loading dose to venous fistula needle, as applicable. Unclamp and gently flush heparin back and forth 3-5 times into fistula or graft. Reclamp. *Do not initiate dialysis for a minimum of three (3) to five (5) minutes after administering heparin loading dose. 1. For Patient #3, the Medical Director failed to ensure the staff adhered to the heparin administration policy and waited 3-5 minutes after administration to initiate treatment. Review of the clinical record indicated Patient #3 had a physician’s order to administer heparin bolus 3000 units intravenously (IV) every dialysis treatment. Review of 9 treatment sheets, dated 5/4/24 through 6/1/24, indicated for 3 of 9 treatments staff failed to wait 3-5 minutes after administration of heparin to initiate treatment including the following: *On 5/4/24 treatment started at 10:52 A.M., heparin was documented as administered at 10:55 A.M., 3 minutes after the initiation of treatment, not the 3-5 minutes prior to the initiation of dialysis per the facility policy. *On 5/9/24 treatment started at 10:56 A.M., heparin was documented as administered at 11:05 A.M., 9 minutes after the initiation of treatment, not the 3-5 minutes prior to the initiation of dialysis per the facility policy. *On 5/16/24 treatment started at 10:50 A.M., heparin was documented as administered at 10:53 A.M., 3 minutes after the initiation of treatment, not the 3-5 minutes prior to the initiation of dialysis per the facility policy. During an interview on 6/6/24 at 10:15 A.M., the Manager of Clinical Services said that it is probably a documentation issue which we will review, however the staff did not follow the policy. 2. For Patient #5 the Medical Director failed to ensure the staff adhered to the heparin administration policy and waited 3-5 minutes after administration to initiate treatment. Review of the clinical record indicated Patient #5 had a physician’s order to administer heparin bolus 6000 units intravenously (IV) every dialysis treatment. Review of 9 treatment sheets, dated 5/6/24 through 6/3/24, indicated for 3 of 9 treatments staff failed to wait 3-5 minutes after administration of heparin to initiate treatment including the following: *On 5/4/24 treatment started at 6:10 A.M., heparin was documented as administered at 6:12 A.M., 2 minutes after the initiation of treatment, not the 3-5 minutes prior to the initiation of dialysis per the facility policy. *On 5/8/24 treatment started at 6:08 A.M., heparin was documented as administered at 6:14 A.M., 6 minutes after the initiation of treatment, not the 3-5 minutes prior to the initiation of dialysis per the facility policy. *On 5/13/24 treatment started at 6:25 A.M., heparin was documented as administered at 6:31 A.M., 6 minutes after the initiation of treatment, not the 3-5 minutes prior to the initiation of dialysis per the facility policy. During an interview on 6/6/24 at 10:15 A.M., the Manager of Clinical Services said that it is probably a documentation issue which we will review, however the staff did not follow the policy. 44223 3. For Patient #11 the Medical Director failed to ensure the staff adhered to the heparin administration policy and waited 3-5 minutes after administration to initiate treatment. Review of the clinical record indicated Patient #11 had a physician’s order to administer heparin bolus 2000 units intravenously (IV) every dialysis treatment. Review of 9 treatment sheets, dated 5/15/24-6/5/24, indicated for 3 of 9 treatments staff failed to wait 3-5 minutes after administration of heparin to initiate treatment, including the following: *On 5/24/24 treatment started at 11:44 A.M., heparin was documented as administered at 11:56 A.M., 12 minutes after the initiation of treatment, not the 3-5 minutes prior to initiation of dialysis per the facility policy. *On 5/27/24 treatment started at 11:00 A.M., heparin was documented as administered at 10:58 A.M., 2 minutes prior to initiation, not the 3-5 minutes prior to initiation of dialysis per the facility policy. *On 6/3/24 treatment started at 11:38 A.M., heparin was documented as administered at 11:39 A.M., 1 minute after initiation, not the 3-5 minutes prior to initiation of dialysis per the facility policy. During an interview on 6/6/24 at 10:15 A.M., the Manager of Clinical Services said that it is probably a documentation issue which we will review, however the staff did not follow the policy.”

“GOV-RN, MSW, & RD AVAIL TO MEET PT NEEDS CFR(s): 494.180(b)(1) The governing body or designated person responsible must ensure that- The registered nurse, social worker and dietitian members of the interdisciplinary team are available to meet patient clinical needs; This Standard is not met as evidenced by: 10249 Based on record review, staff interviews, review of Governing Body Meeting minutes, and policy review, the Governing Body failed to ensure that a Social Worker would be available to meet the clinical needs of the Dialysis patients when the facility social worker had a planned leave of absence. Findings include: Review of the facility policy entitled, Governing Body Bylaws, confirmed and adopted by Facility Governing Body October 4, 2019, indicated the following, but not limited to: PURPOSE *The primary purpose of the facility is to provide outpatient dialysis and support services to patients with End Stage Renal Disease (ESRD) and Acute Kidney Injury (AKI). The facility is part of a national network of ESRD facilities owned and operated nationwide by DaVita, and is committed to providing appropriate, safe and efficient quality of care to its patients in accordance with the DaVita standards of quality, efficiency ad patient safety. SERVICES *The Governing Body shall ensure that the Facility provides dialysis services, as well as adequate laboratory, social and dietetic services to meet the patient needs. *Ensure that the Facility is in compliance with all applicable state, federal, and local rules and requirements related to all the service provided. PERSONNEL *The Governing Body shall maintain and implement written personnel polices and procedures that support sound patient care and promote good personnel practices. *All members of the Facility’s staff are qualified to perform the duties and responsibilities assigned to the and meet such federal, state, and local professional requirements as may apply. ADMINISTRATION *The Administrator shall at a minimum, in collaboration with the other GB (Governing Body) members ensure that the facility employs the number of qualified personnel needed to safely and effectively operate the facility. During an interview on 6/5/24 at 11:30 A.M., the Regional Operations Director said he was made aware of the facility Social Worker going out on leave in January 2024. He said that he was hoping to receive assistance from the corporate Social Worker, but she was not licensed in the state of Massachusetts and no longer worked for the company. He said they did have coverage until the end of January 2024. During an interview on 6/5/24 at 2:45 P.M., the Registered Dietitian said that there were 39 assessments incomplete due to not having a social worker available to complete the comprehensive assessments. She also said that all interdisciplinary team members must complete their assessment in order for the computer program to generate a plan of care. During an interview on 6/6/24 at 12:30 P.M., the Facility Administrator (FA) said that the social worker left January 22, 2024 for a planned leave, and a second social worker filled in until the end of January 2024. There has been no coverage from a social worker since then. The FA said he was made aware of the social worker’s request for an extension of her leave in April 2024, and just most recently 6/3/24. The FA said it was discussed at the Governing Body Meetings in April and June, but was not employed at the clinic until February 2024. Review of the Governing Body Meeting minutes, dated January 2, 2024 through June 3, 2024 indicated the following documentation: *January 2, 2024 through April 2, 2024 there was no documented discussion of social worker coverage during the time the facility social worker would be going on a planned leave of absence. *April 29, 2024-New business-Discussion of assessments/POC/notes. As of 4/29/24 we have 32 overdue assessments, 30 overdue plans of care, and 88 overdue monthly notes. Our MSW (medical social worker) is out on leave. Below is the action plan to complete: *upon retuning from leave the MSW will work to complete the above items. Plans of care completed July 1st, Assessments completed by 6/15/24, Notes to be completely weekly for each month. FA to work with MSW around the scheduling process to complete and communicate daily to help drive completion ad ensure patients are getting timely follow up from the MSW. *June 3, 2024-MSW was scheduled to return from leave on 5/28/24. MSW was not able to return at this time. As of 6/3/24 have 39 assessments overdue and 39 plans of care overdue. Progress notes from the MSW have not been completed since January. Leadership team to work together on a coverage plan to address gap coverage. Lead social worker emailed on 6/3/24 to address coverage concerns. The Governing Body failed to have an effective, documented plan to ensure there was social worker coverage at the dialysis center. The Governing Body failed to implement a plan to address documentation including: conducting assessments, care plan development, and quarterly progress notes, to ensure that the patient’s psychosocial needs were being met while the facility’s social worker was on a planned leave of absence. As of 6/6/24, there was no plan in place to ensure that social worker assessments and care plans would be completed timely.”