Fmc East Orange

“CFC-PATIENT ASSESSMENT CFR(s): 494.80 This Condition is not met as evidenced by: 39223 Based on observation, staff interview, and review of facility documentation, it was determined that members of the interdisciplinary team failed to appropriately assess each patient’s individual needs by: 1) Failing to report patients who experience abnormally low heart rates pre-treatment and during hemodialysis treatment to the charge nurse and nephrologist (V-502), 2) Failing to complete a comprehensive assessment for patients under the care of the same physician (Staff 10) (V-502), 3) Failing to implement patient dialysis treatment prescriptions as ordered by the physician for five of nine hemodialysis treatment flowsheets reviewed. (V-503), and 4) Failing to ensure that an initial comprehensive assessment was conducted by all members of the interdisciplinary team (IDT). (V-516)”

“PR-RECEIVE UNDERSTANDABLE INFORMATION CFR(s): 494.70(a)(2) The patient has the right to- (2) Receive all information in a way that he or she can understand; This Standard is not met as evidenced by: 37656 Based on review of one of two medical records of a newly admitted patient (Medical Record 4), review of facility policy, and staff interview, it was determined that the facility failed to ensure that each patient receives all information in a way that he or she can understand. Findings include: A review of Patient (P) 4’s medical record revealed that P4’s primary language was Spanish. Documentation dated 11/15/23 on the psychosocial assessment by Staff (S) 10, a Social Worker (SW), indicated, “... SW will get an interpreter to speak to pt [patient] as [he/she] does not speak English. ...” On 11/3/23, P4 signed the following forms which were written in English: “ACKNOWLEDGEMENT OF RECEIPT OF FMCNA PATIENT’S RIGHTS”; “Confirmation of Consent for In-center Hemodialysis Treatment”; “Acknowledgement of Patient Responsibilities”; “Acknowledgement of Receipt of FMCNA Notice of Do Not Resuscitate (DNR) Practices”; and “Acknowledgment of FMCNA Patient Grievance Procedure.” The above forms lacked documented evidence that a language interpreter was utilized or the forms were translated from English to Spanish. During an interview on 1/5/24 at 11:25 AM, S1, Clinical Manager, stated that P4 understood some English but spoke very little English. S1 stated that they have the above listed forms in Spanish. During an interview on 1/5/24 at 1:30 PM, S10, Social Worker, stated that P4 speaks very little English and could benefit from a language interpreter to explain admission documents or use forms written in Spanish language. S10 also stated that a language translation line was available in the facility. S10 stated he/she had used a staff member who speaks Spanish to interpret for the patient. A review of the facility policy titled, “Languages and Communication Barriers,” published 9/05/2023, states, “... Patients have the right to receive information regarding their care in a manner they can understand. Facilities should assess patient communication needs, including what methods of communication or resources they use and are comfortable with, and make reasonable accommodations to ensure that patients can understand verbal and/or written information given to them by staff. ... Staff must document in the medical record how information was explained to a patient ... with limited English proficiency and whether a qualified interpreter or other method was used to communicate with the patient. ...” N.J.A.C. 8:43A-16.2(a)(4)”

“PA-ASSESS CURRENT HEALTH STATUS/COMORBIDS CFR(s): 494.80(a)(1) The patient’s comprehensive assessment must include, but is not limited to, the following: (1) Evaluation of current health status and medical condition, including co-morbid conditions. This Standard is not met as evidenced by: 48966 Based on one of one observation of a patient with low blood pressure (Patient (P) 1), medical record reviews, staff interviews, and review of facility documents, it was determined that the facility failed to ensure that: 1) Patients who experience abnormally low heart rates pre-treatment and during hemodialysis treatment are reported to the charge nurse and nephrologist for one of one patient (P1) with a low heart rate, and 2) A comprehensive assessment is completed for one of two patients (P2) under the care of Staff (S)10. Findings include: 1. On 1/3/24 at 10:50 AM, Staff (S) 12, a Registered Nurse (RN), initiated hemodialysis on P1 through a Central Venous Catheter (CVC) in Station 15. On the hemodialysis machine, the heart rate (HR) displayed 38 beats per minute (bpm) at 10:44 AM, 52 bpm at 10:49 AM and 43 bpm at 10:58 AM. A review of P1’s medical record indicated a physician order, “chronic bradycardia [slow heart rate], okay to treat patient if HR < [less than] 60 BPM. Notify the MD [medical doctor] if HR < 45 BPM for further orders.” A review of the hemodialysis flowsheets from 12/15/23 through 1/3/24 was conducted and revealed the following: On 12/22/23 at 11:15 AM, the HR was 43 bpm as documented by the RN. There was no documented evidence that the pulse was verified manually, or the Nephrologist was notified as ordered. On 12/29/23 at 2:31 PM, the HR was 42 bpm as documented by the Patient Care Technician (PCT). There was no documented evidence that the pulse was verified manually, or the Nephrologist was notified as ordered. On 1/3/24 at 11:24 AM, a note documented by the RN stated, “... HR low, patient asymptomatic, chronic bradycardic episodes noted during treatment, will monitor. ...” There was no documented evidence that the Nephrologist was notified as ordered. On 1/3/24 at 11:33 AM, the HR was 40 bpm as documented by the PCT. There was no documented evidence that the pulse was verified manually, the Nephrologist was notified as ordered, or that the RN was notified. On 1/3/24 at 12:03 PM, the HR was 44 bpm as documented by the PCT. There was no documented evidence that the pulse was verified manually, that the Nephrologist was notified as ordered, or that the was RN notified. During an interview on 1/3/24 at 10:59 AM with S12, he/she was asked about the low heart rates that displayed on the hemodialysis machine. S12 stated the patient has chronic low heart rates and I will make a note if asymptomatic. S12 stated he/she was not aware of any special orders for P1 regarding low heart rates. During an interview on 1/3/24 at 11:22 AM, S2, the Charge Nurse, stated there is no special heart rate orders for P1. P1’s low HR was normal for him/her and if he/she had no symptoms, a note would be written. P1 takes anxiety medication which can affect his/her HR. S2 stated that if the HR is below 45, then the Nephrologist needed to be called. S2 also stated, if needed, the RN would lower the blood flow rate or give normal saline if the pulse is low. A review of the facility policy titled, “Determination of Pulse Rate,” published on 2/7/22, stated, “ ... Policy ... Incenter patients: obtain pulse readings pre-and-post-treatment and every 30 minutes or more during hemodialysis as needed ... Verify pulses manually if aberrant readings are noted on the digital display. Consider verifying a pulse manually if a digital pulse reads below 60 or greater than 100 beats per minute ... Establishing and Setting Upper and Lower Pulse Parameters ... The Medical Director in conjunction with the Clinical Manager will determine what the pulse upper and lower range will be for the facility. The parameters can also be modified by the nephrologist for individual patients that may require modifications based on their comorbid conditions ...” N.J.A.C. 8:43A-24.6(d)(3); 24.6(d)(4) 39223 2. On 1/3/24 at 11:14 AM, Patient (P) 2 stated that he/she did not visit the Nephrologist at the office and did not see the Nephrologist in the facility. P2 stated that he/she had no idea who his/her Nephrologist was, Staff (S) 10. When asked if he/she ever had an appointment or would make an appointment with S10, P1 stated, “I don’t know who that is. ... What’s he going to do for me?” A review of P1’s medical record revealed a Plan of Care dated 10/25/23. The medical record lacked documented evidence of a physician’s comprehensive assessment for the Plan of Care. During an interview on 1/4/24 at 12:20 PM, S1, the Clinical Manager, stated that she and the Medical Director have spoken with S10 about monthly rounding and completing assessments on his patients, but there has not been improvement. S1 stated that physicians should complete a comprehensive assessment on their patients for the Plan of Care meeting.”

“PA-APPROPRIATENESS OF DIALYSIS RX CFR(s): 494.80(a)(2) The patient’s comprehensive assessment must include, but is not limited to, the following: (2) Evaluation of the appropriateness of the dialysis prescription, This Standard is not met as evidenced by: 37656 Based on review of Medical Record 3, staff interview, and a review of facility documents, it was determined that the facility failed to implement patient dialysis treatment prescriptions as ordered by the physician for five of nine hemodialysis treatment flowsheets reviewed. Findings include: A review of Patient (P) 3’s medical record revealed the following: The hemodialysis orders dated 12/18/23 stated, “... EDW (estimated dry weight) 55.5 (kg) [kilograms]...” The treatment flow sheets revealed that P3’s EDW was documented as 54.80 kg on the following dates: 12/20/23, 12/22/23, 12/24/23, 12/27/23, and 12/29/23. On 1/4/24 at 2:00 PM, the treatment flow sheets were reviewed with Staff (S)1, Clinical Manager, and confirmed that the change in the order for the EDW on 12/18/23 was not carried out by the registered nurse (RN) and it should have been changed. A review of the facility policy titled, “Nursing Supervision and Delegation,” published 11/06/2023, states, “The registered nurse must evaluate each patient preferably within an hour or according to state requirements ... to: ... Review accuracy and completeness of treatment and patient data ... Review patient treatment prescription and equipment parameters to verify correct settings, and if dialysis prescription is being followed. ... Verify machine safety checks have been completed. ...” N.J.A.C. 8:43A-24.6(d)(4)”

“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: 37656 Based on a review of one of two medical records of new patients (Patient 3), staff interview, and a review of facility documents, it was determined that the facility failed to ensure that an initial comprehensive assessment is conducted by all members of the interdisciplinary team (IDT) on a newly transferred patient. Findings include: A review of Patient (P) 3’s medical record revealed the following: P3 was transferred to the facility on 11/8/23. The Plan of Care meeting was on 12/29/23. The medical record did not contain documented evidence of an initial comprehensive assessment by the physician. On 1/5/23 at 2:30 PM, Staff (S) 5, Director of Operations, stated there was no initial comprehensive assessment from the physician in the medical record. A review of the facility policy titled, “Comprehensive Interdisciplinary Assessment (CIA) and Plan of Care (POC),” published 7/03/2023, states, “... CIA and POC for Transfers ... If a patient transferring dialysis facility and the transferring facility has NOT provided a current CIA and POC, the receiving facility must complete a CIA and POC within 30 days of admission. ...” N.J.A.C. 8:43A-24.13(b)”

“POC-VA MONITOR/PREVENT FAILURE/STENOSIS CFR(s): 494.90(a)(5) The patient’s vascular access must be monitored to prevent access failure, including monitoring of arteriovenous grafts and fistulae for symptoms of stenosis. This Standard is not met as evidenced by: 48966 Based on one of two observations of the removal of fistula needles post treatment, staff interview, and a review of facility policy, it was determined that the facility failed to ensure that vascular accesses are monitored to prevent access failure when using venipuncture clamps after termination of hemodialysis. Findings include: On 1/3/24 at 10:23 AM in Station 13, Staff (S) 7, a Patient Care Technician (PCT), removed the arterial needle from Patient (P) 8’s right upper arm graft and placed gauze over the needle site. S7 then applied a white venipuncture site clamp on the access site at 10:23 AM. Staff did not monitor or assess the vascular access site from the time the clamp was placed on P8 until 51 minutes later, at 11:14 AM, when S7 removed the clamp. During an interview at 11:15 AM, S7 explained clamps should not be kept on longer than 20 minutes once the clamp is placed on the needle site after removing the needles. S7 stated the patient has a tendency to have prolonged bleeding but usually stops in 15 minutes. A review of S7’s personnel record indicated that S7 successfully completed annual Clinical Skills Validation for PCTs on 4/19/23. During an interview on 1/5/24 at 1:25 PM, S1, the Clinical Manager, stated the Annual Clinical Skills Validation for PCTs includes access care and clamps procedure. A review of P8’s medical record contained documented evidence of a physician’s order for venipuncture clamps to the patient’s right upper arm graft needle sites post treatment. A review of the facility policy titled, “Venipuncture Site Clamps Procedure,” published 7/6/21, stated, ...”Policy ...use only one clamp at a time to prevent excessive pressure which can cause thrombosis. While the clamp remains on the access, check for thrill every 10 minutes. Do not leave clamp in place longer than 20 minutes ...Venipuncture Clamp Procedure ...10. Leave clamp on until bleeding has stopped. Do not leave clamp in place longer than 20 minutes without removing it to check that bleeding has stopped. 11. Check access for thrill every 10 minutes ...” N.J.A.C. 8:43A-24.6(f)(1)(iii)”

“POC-PTS SEEN BY MED STAFF 1X/MO CFR(s): 494.90(b)(4) The dialysis facility must ensure that all dialysis patients are seen by a physician, nurse practitioner, clinical nurse specialist or physician’s assistant providing ESRD care at least monthly, as evidenced by a monthly progress note placed in the medical record, and periodically while the hemodialysis patient is receiving in-facility dialysis. This Standard is not met as evidenced by: 39223 Based on medical record review, interviews, and review of facility documents, it was determined that the facility failed to ensure monthly notes are completed by the physician for two of two patients (Patient 2 and Patient 7) under the care of Staff (S)10. Findings include: On 1/3/24 at 11:14 AM, Patient (P) 2 stated that he/she did not visit the Nephrologist at the office and did not see the Nephrologist in the facility. P2 stated that he/she had no idea who his/her Nephrologist was, Staff (S) 10. When asked if he/she ever had an appointment or would make an appointment with S10, P2 stated, “I don’t know who that is. ... What’s he going to do for me?” On 1/3/24 at 11:30 AM, S6, a Registered Nurse (RN), stated that while it is possible that S10 comes to the facility to round on patients on the days that she is not working, she has not seen S10 at the facility. A review of P2’s medical record lacked documented evidence of a physician’s monthly progress note for July, August, September, October, November, and December 2023. A review of P7’s medical record lacked documented evidence of a physician’s monthly progress note for July, September, October, and December 2023. S1, the Clinical Manager, was unable to find the physician monthly progress notes in either P2 and P7’s medical records at the facility. Upon request, S1 was able to receive a faxed copy of the handwritten missing physician monthly progress notes from S10 on 1/4/24 at 12:28 PM. S1 confirmed that until the surveyor requested the progress notes on 1/4/24, the physician monthly progress notes were not available in P2 and P7’s medical records. During an interview on 1/4/24 at 12:20 PM, S1, the Clinical Manager, stated that S10 does not come to the facility to round on his patients as he is supposed to. S1 stated that when S10 was informed of the need to round on his patients, he would continuously say that he would come in to the facility, but then failed to actually do so. During an interview on 1/4/24 at 1:42 PM, S11, the Medical Director, stated that he did speak with S10 “two or three times” about rounding on his patients at the facility. A request to speak with S10 was unable to be accommodated. N.J.A.C. 8:43A-24.13(d) 48966”

“MD RESP-STAFF ED, TRAINING & PERFORM CFR(s): 494.150(b) Medical director responsibilities include, but are not limited to, the following: (b) Staff education, training, and performance. This Standard is not met as evidenced by: 39223 Based on medical record review, interviews, and review of facility documents, it was determined that the medical director failed to ensure that all physicians complete expected duties on their patients for one of two patients (Patient 1) reviewed, who were under the care of S10. Findings include: A review of Patient (P) 1’s medical record lacked documented evidence of a physician’s monthly progress note for July, August, September, October, November, and December 2023. Upon request for the monthly progress notes, Staff (S) 1, the Clinical Manager, was able to provide faxed copies of handwritten monthly progress notes from the above listed dates. S1 confirmed that the provided notes were not present in the facility until this surveyor requested them after reviewing P1’s medical record and S1 had to reach out to S10’s office to obtain them. During an interview on 1/4/24 at 12:20 PM, S1, the Clinical Manager, stated that S10 does not come to the facility to round on his patients as he is supposed to. S1 stated that when S10 was informed of the need to round on his patients, he would continuously say that he would come in to the facility, but then failed to actually do so. A review of Governing Body Meeting Minutes revealed the following: A Governing Body meeting held on 6/15/23 stated that S10 had not been compliant with his physician rounds at the facility and the Governing Body had not been successful with attempts to reach S10 by telephone. The meeting minutes stated, “... Medical Director aware. Medical Director will communicate with [S10] personally. ...” A Governing Body meeting held on 9/21/23 stated that S10 had not been compliant with his physician rounds at the facility and stated, “... The Governing Body has attempted to connect with [S10] via telephone multiple times with no success. Medical Director aware. Medical Director will communicate with [S10] personally. ...” A Governing Body meeting held on 11/16/23 stated, “... The Governing Body has attempted to connect with [S10] via telephone multiple times with no success. Medical Director aware. Medical Director will communicate with [S10] personally. ...” In addition, a copy of a letter sent to S10 by the Governing Body, dated 11/17/23, stated, “... The Governing Body of [facility name] is sending you this Delinquent Progress Notes Entry Warning, as you have no provider notes documentation for your patient [initials], for October and November 2023. This is in violation of the FMC Medical Staff By-laws and as of this date you have 15 days to comply. If there are no progress notes entries and/or office visit notes after the 15 days of receipt of this letter, you will receive written notice of suspension of admitting Privileges. If the delinquent progress notes are not submitted 45 days of receipt of the suspension, you will receive notice that the Medical Staff clinical privileges have been suspended. This suspension will remain in effect until all delinquent progress notes are entered. ... Please ensure compliance with the Medical Staff Bylaws by arranging to come to the facility and enter submit progress notes, as quickly as possible, by December 31, 2023. If the progress note entries are not signed by then you will receive written notice of suspension of admitting privileges. ...” During an interview on 1/4/24 at 1:42 PM, S11, the Medical Director, stated that he did speak with S10 “two or three times” about rounding on his patients at the facility. S11 stated that this was about two or three months ago. S11 stated that he should not have to tell someone else what to do and that he would have to speak to his boss about what to do next. When asked to clarify who S11’s boss is, S11 was unable to state who his boss was. S11 later clarified that he was the medical director of this facility and that he is in charge of the physicians at this facility. A review of S11’s personnel file revealed that S11 signed a confirmation of training on 11/30/17 for Medical Director Compliance Training. A copy of the Medical Director Duties and Responsibilities, version 11/4/08, was provided by S1 and stated, “... Medical Director Duties & Responsibilities include, but are not limited to, those set forth below. ... A. On-call Availability ... 2. If an attending physician cannot be located or contacted and no coverage is available or responding, provide guidance, as Medical Director, to Facility staff on how to address patient issues (e.g., refer patient to hospital, etc.) until the attending or covering physician can be contacted. The Medical Director is to follow-up with unresponsive attending physicians and take appropriate actions, in conjunction with the Governing Body as necessary, to prevent future occurrences.” During an interview on 1/4/24 at 1:10 PM, S5, the Director of Operations, stated that S10 completes what she asks him to do, but he does not sustain it. S5 confirmed that no suspensions have been implemented. S10 stated that she did not get a chance to review any updates until the day of survey so no further actions had been taken. A request to speak with S10 was unable to be accommodated.”