Fmc Ewing

“MD RESP-ENSURE ALL ADHERE TO P&P CFR(s): 494.150(c)(2)(i) The medical director must- (2) Ensure that- (i) All policies and procedures relative to patient admissions, patient care, infection control, and safety are adhered to by all individuals who treat patients in the facility, including attending physicians and nonphysician providers; This Standard is not met as evidenced by: 48966 Based on a review of facility documents, and staff interview, it was determined that the facility failed to ensure that adverse events are documented in the Patient Safety Data Entry Site. Findings include: A review of the “Adverse Events Report” lacked documented evidence that the serious safety event involving the Involuntary Discharge (IVD) of Patient (P) 1 on 1/28/25 was recorded in the Patient Safety Data Entry site. During an interview at 12:51 PM, Staff (S) 2, the Clinical Manager, confirmed the IVD event was not documented in the Patient Safety Data Entry site as an adverse event. S2 stated the IVD was documented in the ‘Clinical Notes Report,’ Social Worker progress note, the Governing Body Meeting Minutes and Quality Assurance and Performance Improvement (QAPI). S2 stated, “It must have gotten lost in the shuffle.” Facility policy titled, “Patient Safety Event Reporting and Documentation,” published 2/6/2023, stated, “ ... Policy When a Near Miss, Safety Event or Serious Safety Event occurs, staff are required to report, document, and review the event as noted in the policy. Staff are responsible for timely completion of these policy requirements. ... Serious Safety Event Results in severe to life threatening patient clinical harm, not due to an underlying disease or condition ... Step 1 ... Documentation Clinical staff will perform documentation in the patient medical record, Patient Safety Data Entry Site ...Categories, Event Description & Definitions Below is a table ... Category Behavior Event Description Abusive/Violent Behavior Definitions Verbal or written threats, physical harm, or threat of harm to the individual patient and/or others that impacts the safety of their wellbeing ...””

“IC-WEAR GLOVES/HAND HYGIENE CFR(s): 494.30(a)(1) Wear disposable gloves when caring for the patient or touching the patient’s equipment at the dialysis station. Staff must remove gloves and wash hands between each patient or station. This Standard is not met as evidenced by: 28297 Based on observation, interview, and policy review, it was determined that the facility failed to ensure patients washed or sanitized their hands after holding their access sites (A vascular access is created so that blood can be drawn from the body and run through a dialysis machine, where excess fluid and toxins are removed from the blood. The filtered blood then flows back through the access into the body) for one of three survey days. The failure for patients to wash or sanitize hands after holding access sites has the potential for cross contamination and could affect 87 in-center patients. Findings include: During an observation on 06/06/24 at 10:20 AM, Patient (P)10 at Station 6 applied pressure to their right upper arm access site until bleeding had stopped. When finished, the patient removed his/her glove and Patient Care Technician (PCT) 4 assisted the patient to the scale to retrieve his/her weight. The patient did not wash or sanitize their hands and PCT4 did not instruct or encourage the patient to wash or sanitize their hands. During an interview on 06/06/24 at 10:30 AM, PCT4 acknowledged the patient at Station 6 did not wash or sanitize hands after holding access sites but should have to prevent cross contamination. During an interview on 06/07/24 at 1:35 PM, the Clinic Manager stated patients should wash or sanitize hands after holding access sites at the end of treatment to prevent cross contamination of blood borne pathogens. Review of the facility policy titled, “Hand Hygiene,” revised 11/06/23 indicated, “...Hand Hygiene: Patients Patient should perform hand hygiene if able, prior to and after each dialysis treatment ...Gloves must be provided to patients when performing procedures which exposure to blood or body fluids, such as when self-cannulating or holding access sites post treatment to achieve homeostasis. To help ensure the prevention of cross contamination to their family members or other patients, hand hygiene must be performed.” N.J.A.C 8:43A-24.4(b)”

“IC-IF TO STATION=DISP/DEDICATE OR DISINFECT CFR(s): 494.30(a)(1)(i) Items taken into the dialysis station should either be disposed of, dedicated for use only on a single patient, or cleaned and disinfected before being taken to a common clean area or used on another patient. -- Nondisposable items that cannot be cleaned and disinfected (e.g., adhesive tape, cloth covered blood pressure cuffs) should be dedicated for use only on a single patient. -- Unused medications (including multiple dose vials containing diluents) or supplies (syringes, alcohol swabs, etc.) taken to the patient’s station should be used only for that patient and should not be returned to a common clean area or used on other patients. This Standard is not met as evidenced by: 28297 Based on observation, interview and policy review, it was determined that the facility failed to ensure non-disposable items taken into a patient station is disinfected prior to use at another patient station for one of three survey days. This failure has the potential for cross contamination and could affect 87 in-center patients. Findings include: During observation on 06/05/24 at 2:45 PM, Patient Care Technician (PCT)1 was at Station 12 using a “styles pen” to enter data into the dialysis machine at the patient station. PCT1 then went to Station 4 and used the same “styles pen” to enter data into the dialysis machine without disinfecting it in between. During an interview on 06/05/24 at 2:45 PM, PCT1 confirmed he/she was using a pen with an eraser on the end (referred to as a styles) to enter information at multiple stations. PCT1 stated it saved his/her fingers from having to enter data. PCT1 acknowledged that it was cross contamination to go from one station to another with the device and not disinfecting in between patient stations. During an interview on 06/07/24 at 1:35 PM, the Clinic Manager confirmed it was not ok for staff to use a “styles pen device” from station to station as it was considered cross contamination. Review of the facility’s policy titled, “Cleaning and Disinfection the Dialysis Station,” revised 09/05/23, indicated, “ ...General Cleaning. The dialysis station could become contaminated with blood and other body fluids during treatment. After use- any non-disposable equipment and supplies brought into the station ...must be disinfected with 1:100 bleach ...before being removed from the dialysis station ...” N.J.A.C 8:43A-24.4(b)”

“IC-STAFF EDUCATION-CATHETERS/CATHETER CARE CFR(s): 494.30(a)(2) Recommendations for Placement of Intravascular Catheters in Adults and Children I. Health care worker education and training A. Educate health-care workers regarding the ... appropriate infection control measures to prevent intravascular catheter-related infections. B. Assess knowledge of and adherence to guidelines periodically for all persons who manage intravascular catheters. II. Surveillance A. Monitor the catheter sites visually of individual patients. If patients have tenderness at the insertion site, fever without obvious source, or other manifestations suggesting local or BSI [blood stream infection], the dressing should be removed to allow thorough examination of the site. Central Venous Catheters, Including PICCs, Hemodialysis, and Pulmonary Artery Catheters in Adult and Pediatric Patients. VI. Catheter and catheter-site care B. Antibiotic lock solutions: Do not routinely use antibiotic lock solutions to prevent CRBSI [catheter related blood stream infections]. This Standard is not met as evidenced by: 28297 Based on observation, interview, and policy review, it was determined that the facility failed to ensure staff change gloves and sanitize hands during a Central Venous Catheter (CVC-plastic tube inserted into the vein used for hemodialysis) dressing change as required for one of two observations. The failure to change gloves and sanitize hands has the potential for cross contamination of the CVC and could affect 24 patients with CVC’s in the unit. Findings include: During an observation on 06/05/24 at 3:48 PM, Registered Nurse (RN)2 was initiating the treatment for Patient (P)11 at Station 4 via a CVC. RN2 removed the old, soiled dressing and proceeded to clean and dress the access site without removing gloves and sanitizing hands as required. During an interview on 06/05/24 at 4:00 PM, RN 2 confirmed he/she failed to remove gloves and sanitize hands after removing the old dressing from the CVC site for P11 as required to prevent cross contamination. During an interview on 06/07/24 at 1:35 PM, the Clinic Manager confirmed staff were required to remove gloves and sanitize hands after removing the old dressing form the CVC during the dressing change to prevent contamination of the CVC. Review of the facility’s policy titled, “Central Venous Catheter (CVC) Dressing Change,” revised 05/06/24, indicated, “...Removal of Dressing and Inspection of Site ...Follow the steps below to remove dressing and inspect the exit site before the initiation of treatment ...Inspect and remove the old dressing. Check to see if the dressing looks visible soiled with exudate or blood. Visually inspect the exit site ...Discard dressing and remove gloves. Perform hand hygiene ...” N.J.A.C. 8:43A-24.8(b)”

“PE-EQUIPMENT MAINTENANCE-MANUFACTURER’S DFU CFR(s): 494.60(b) The dialysis facility must implement and maintain a program to ensure that all equipment (including emergency equipment, dialysis machines and equipment, and the water treatment system) are maintained and operated in accordance with the manufacturer’s recommendations. This Standard is not met as evidenced by: 28297 Based on observations, interview, policy review, and document review, it was determined that the facility failed to follow the policy for dialysis (an artificial means of kidney function that removes the waste and excess fluid from the blood by passing it through a filter) treatments by not maintaining the arterial drip chambers (a pressure and air monitoring component of the dialysis bloodline tubing) fluid levels at 85-95% full for one of three survey days. Failure to follow the facility policy has the potential to result in equipment malfunction and/or failure and negatively impact the safety and well-being of the 87 patients receiving dialysis treatments in this facility. Findings include: Observation of the hemodialysis treatment area on 06/05/24, revealed the following: At 2:15 PM, the arterial drip chamber fluid levels were less than 10% full at Station 6. At 3:10 PM, Registered Nurse (RN)1 acknowledged and confirmed the arterial drip chamber at Station 6 was less than 10% and should be three-quarters (3/4) full to prevent air from getting into the system. At 3:45 PM, RN2 initiated the treatment at Station 5 for Patient (P)9. RN2 confirmed he/she was finished with initiation of the treatment and had walked away from the machine. During an interview with RN 2 at 3:55 PM, he/she confirmed the arterial drip chamber was less than 25% full at Station 5 and should have been at least 80% full to prevent air from getting into the system. During an interview on 06/07/24 at 1:35 PM, the Clinic Manager confirmed that the facility policy stated the arterial drip chambers should be checked during initiation of treatment and throughout the treatment to be maintained at 3/4 full to prevent air from getting into the dialysis system. Review of the facility’s policy titled, “Initiation of Treatment Using a Central Venous Catheter and Optiflux Single Use Ebeam Dialyzer,” revised 05/06/24, indicated, “Final Machine Verification: ...The arterial chamber is 85-95% full ...” Review of the undated Manufacture Directions for Use for “Combi Set True Flow Series, Hemodialysis Blood Tubing Set with Priming Set and Transducer Protector,” indicated, “ ...Priming Precautions ...Prime pre-pump arterial chamber 85-95% full ...During treatment ...maintain fluid level in pre-pump arterial chamber at 85-95% full ...” N.J.A.C. 8:43A-24.4(a)”

“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: 28297 Based on interview, medical record review, facility document review, and review of the facility’s policy, it was determined that the facility failed to ensure an unstable assessment and Plan of Care (POC) was completed for one of seven sampled patients (Patient (P)3). The failure to complete an unstable assessment and POC has the potential for missed opportunities for improved care and could affect 87 in-center patients. Findings include: Review of the “Hospital Readmit Form” from June 2023 until May 2024, provided by the facility, revealed P3 was hospitalized from 06/16/23 until 07/03/23 with a diagnosis of anemia. Review of the “ESRD Comprehensive Social Worker Assessment,” completed on 11/24/23, provided by the facility, for P3 revealed the Social Worker documented the reason for the assessment was for the annual Comprehensive Interdisciplinary Assessment. The Social Worker documented, “ ...Returned home 2[sic] months ago after being in sub-acute rehab [rehabilitation] and hospital for 2+ months ...” Review of the “Hemodialysis Treatment” summary for P3 revealed the patient did not receive treatment at the facility from 06/13/23- 07/04/23 due to hospitalization however did return for treatment on 07/04/23. Review of the Plan of Care for P3 revealed a Plan of Care was not developed until 11/24/23 that was documented as an annual Plan of Care. The facility did not complete an unstable Plan of Care for the extended hospitalization and change of condition in July 2023. During an interview on 06/07/24 at 1:35 PM, the Clinic Manager stated there was a different Social Worker here at the time P3 care plan should have been made unstable due to extended hospitalization however it was missed by the entire Interdisciplinary Team. Review of the facility policy titled, “Comprehensive Interdisciplinary Assessment and Plan of Care,” revised 07/03/23, indicated, “ ...The following are unstable criteria: Extended or Frequent Hospitalization: Hospitalization of more than 15 days ...Marked deterioration in health status-IDT to identify and document the specific reasons, such as: Change in ambulation sever enough to interfere with the patient’s ability to follow aspects of the treatment plan ...” N.J.A.C. 8:43A-24.4(a)”

“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: 28297 Based on interview, record review, and review of facility policy, it was determined that the facility failed to ensure two of nine sampled patients (Patient (P)5, and P6) were monitored every 30 minutes in accordance with policy. The failure to monitor patients every 30 minutes has the potential to not capture a potential adverse event in a timely manner and could affect all 87 in-center hemodialysis patients. Findings include: 1. Review of the medical record for P5 revealed the facility admitted the patient on 12/18/23, with a diagnosis including End Stage Renal Disease (ESRD). Review of six dialysis flow records provided by the facility for P5 from 05/22/24- 06/03/24, revealed the following: On 05/22/24, the patients’ blood pressure was checked at 10:33 AM with a reading of 159/91, and was not checked again until 11:39 AM, with a reading of 179/92. This was 1 hour and 6 minutes later. Continued review of the flow sheet for 05/22/24 revealed the blood pressure was checked at 1:05 PM with a reading of 166/91, and not again until 2:09 PM with a reading of 177/85. This was 1 hour and 4 minutes later. On 05/27/24, P5’s blood pressure was checked at 11:09 AM with a reading of 174/93, and not again until 12:32 PM, reading 153/87. This was 1 hour 23 minutes later. 2. Review of the medical record for P6 revealed the facility admitted the patient on 04/05/23, with diagnosis including ESRD. Review of six dialysis flow records provided by the facility for P6 from 05/22/24- 06/03/24, revealed the following: On 05/29/24, the patients’ blood pressure was checked at 10:57 AM with a reading of 167/100, and was not checked again until 12:08 PM with a reading of 154/83. This was 1 hour and 11 minutes later. On 05/29/24, revealed the blood pressure was checked at 1:03 PM with a reading of 122/64 and not checked again until 2:07 PM with a reading of 112/72, one hour and 4 minutes later. On 05/31/24 revealed P6’s blood pressure was taken at 1:04 PM with a reading of 149/79 then at 2:00 PM with a reading of 139/75, 56 minutes later, then at 3:03 PM with a reading of 157/74, one hour and three minutes later. During an interview on 06/07/24 at 12:35 PM, Registered Nurse (RN)1 confirmed there were missing blood pressure and monitoring checks for P5 and P6. RN1 stated it was important for patients to be monitored every 30 minutes to ensure they are safe and stable. During an interview on 06/07/24 at 1:35 PM, the Clinic Manager confirmed the missing blood pressures and safety checks on the flow sheets provided and stated staff should be checking the patients’ blood pressure every 30 minutes to ensure the patient was safe. He/she acknowledged that no one was auditing the dialysis treatment flow sheets on a regular basis. Review of the facility’s policy titled, “Patient Assessment and Monitoring,” revised 05/01/23 indicated, “ ...During treatment: Obtain blood pressure and pulse rate every 30 minutes or more often as needed but not to exceed 45 minutes or per state regulations. Document machine parameters and safety checks every 30 minutes or more often but not to exceed 45 minutes or per state regulations ...” N.J.A.C. 8:43A-24.4(a)”

“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: 28297 Based on interview, record review, and review of facility policy, it was determined that the facility failed to ensure two of seven (Patients (P)4 and P5) were given the opportunity to attend and participate in their Plan of Care (POC). The failure to give patients opportunities to be involved in their POC has the potential for missed opportunities for improved care. Findings include: 1. Review of P4’s “Face Sheet,” located in the hard chart, revealed the facility admitted the patient on 07/22/22 with a diagnosis of end stage renal disease (ESRD). Review of P4’s six month “POC,” provided by the facility, dated 04/29/24, revealed the patient did not sign off on the “POC” to indicate the patient participated in the “POC.” 2. Review of the “Face Sheet,” located in the hard chart, revealed P5 was admitted to the facility on 12/18/23 with a diagnosis of ESRD. Review of P5’s “POC,” provided by the facility, dated 04/29/24, revealed the patient did not sign off on the “POC” that would indicate the patient participated in the “POC.” During an interview on 06/07/24 at 11:40 AM, the Social Worker stated he/she had only been back for two months and didn’t realize he/she was responsible to print off the POC’s and get the patient to sign off that they had been educated and informed of the Plan of Care. The Social Worker confirmed P4 and P5 POC’s were not signed off by the patients as required. Review of the facility’s policy titled, “Comprehensive Interdisciplinary Assessment and Plan of Care,” revised 07/03/23, indicated, “... Patient Participation in Plan of Care. The following are recommendations for involving the patient in the development and review of the plan of care: ... Encourage both patient and family to participate In the Plan of care discussions in whatever format the facility and attending physician develop. Notify the patient in writing of the time and date of the Plan of care review ... If the patient and or designee is unable or unwilling to attend the Plan of Care meeting ... the Registered Nurse may review the Plan of care as developed by the IDT at the meeting with the patient and obtain the patients’ signature and any comments. The patients’ level of participation is determined by the patients ...” N.J.A.C. 8:43A-24.4(a)”