Fkc Kennedy Voorhees

“PA-IMMUNIZATION/MEDICATION HISTORY CFR(s): 494.80(a)(3) The patient’s comprehensive assessment must include, but is not limited to, the following: Immunization history, and medication history. This Standard is not met as evidenced by: 37656 Based on a review of two of three medical records (Patient [P]1 and P2), staff interviews, and a review of facility documents, it was determined that the facility failed to review and verify all patient’s current medication allergies with the Nursing Home facilities where the patients reside. Findings include: A review of P1’s Hemodialysis Orders, dated 04/24/25, stated, “Dialyzer: 160NRe Optiplux, Treatment time: 03:00 [3 hours]. 04/26/25 “Dialyzer: Nipro Cellentia 17H, Treatment time: 03:00.” Treatment Medications “... Diphenhydramine (allergy medication) [generic name for Benadryl] 50 mg [milligrams] ORAL PRN [as needed] Anaphylaxis, start date 11/14/24 ...” A review of P1’s treatment flow sheet, dated 04/24/25, stated, “early termination due to itchiness per NP [Nurse Practitioner] order; pt [patient] had red patches all over arms and back; ... oral Benadryl was given” documented by a Registered Nurse (RN). On 04/26/25, P1’s treatment flow sheet indicated that the dialyzer was changed to Nipro Cellentia 17H. RN note stated, “pt complained of itchiness. pt given benadryl 50 mg po. tx [treatment] ended one hour into tx. ...” The treatment was shortened to 57 minutes and P1 was administered 50 mg of oral Benadryl. Upon interview on 05/28/25 at 12:10 PM, Staff (S)1 (Clinic Manager) stated that P1 told the staff that he/she was given new medication at the Nursing Home but did not know the name. S1 stated the medication was discontinued and P1 stopped complaining of itching during dialysis. S1, when asked if they communicated with the Nursing Home regarding the allergy, he/she stated that patients from the Nursing Home come with a binder which is supposed to have the information about the patient, but the new meds (medications) were not written there. S1 also stated that it is hard to communicate with the Nursing Home. The medical record did not contain documentation of the medication that was administered at the Nursing Home that caused the allergic reaction. 51990 A review of P2’s Treatment Sheets, dated 04/25/25 and 04/28/25 revealed the following: The Hemodialysis Orders documented the patient’s listed allergies included “Penicillins [sic],” and it was noted that there were no known food allergies. The treatment data section of the treatment flowsheets on 04/25/25 and 04/28/25 did not contain documentation that P2 complained of itching during the hemodialysis treatment. The Nursing Evaluation Note on 04/25/25 documented at 7:19 PM, stated: “pt with generalized priorities (itching), ... tx terminated early.” The treatment ended at 6:32 PM. On 5/28/25 at 10:00 AM, during an interview, S2 (Charge Nurse) stated that on 04/25/25, P2 experienced itching during hemodialysis, which was suspected to be a dialyzer reaction. In a follow-up interview at 1:30 PM, S1 (Clinic Manager), stated that the patient’s itching was a reaction to an antibiotic prescribed at the nursing home, not the dialyzer. However, S1 could not identify the antibiotic. S1 added that P2 had informed staff of the reaction. When asked if the information was verified with the nursing home, S1 responded, “There was nothing written in the patient’s communication binder from [Name of Nursing Home].” S4 added, “We don’t get a response or a call back when we call.” As of the survey date, the antibiotic remained unidentified, and the allergy was not documented. This was 33 days after the incident. Facility policy titled, Management and Prevention of Anaphylaxis or Allergic Reaction (Adult), published 07/01/24, stated, “... Prevention of Allergic Reaction and Anaphylaxis ... Review patient’s allergy per policy: ... At least monthly. In order to accomplish this requirement, it is recommended that allergy status be reviewed along with the monthly reconciliation/review of home medications. ...””

“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: 50912 Based on staff interviews, medical record reviews and review of facility documents, it was determined the Medical Director failed to ensure that: 1) orders for shortened hemodialysis treatment time are documented in 17 of 55 patients’ medical records and; 2) medication administered to the patient during dialysis is recorded in the medical record in one of one medical record reviewed (Patient (P)1). Findings include: 1. From 04/24/25 to 04/26/25, four adverse events related to patients developing rashes and itching during hemodialysis treatments were reported by the facility. An Ad Hoc (a spontaneous meeting held to address an urgent issue) Governing Body meeting was held on 04/28/25 presided by Staff (S)4 (Director of Operations) and attended by S1 (Clinic Manager), and the Medical Director. A review of the approved Ad Hoc Governing Body meeting minutes, dated 4/28/25, stated, “per Medical Director, ordered three-hour treatments on 04/26/25” on all in-center patients receiving hemodialysis on the first, second, and third shifts. Upon interview on 05/28/25 at 1:00 PM, S4 stated that the Medical Director decided to shorten the treatment hours for all 55 patients scheduled for hemodialysis on 04/26/25 to give the facility more time to investigate the root cause of the adverse reaction and to make sure that no other patients have the same reaction for that day. S4 stated that all 55 hemodialysis patients received shortened treatments of three hours on 04/26/25. At 1:18 PM, a review of the printed physician orders from the electronic medical records dated 04/26/25 revealed that 22 patients on the second shift and 16 patients on the third shift had received shortened treatments with the corresponding documented physicians orders that stated “Special attention: per ___ [doctor’s name], 3 [three] hours treatment time for all patients on 04/26/25, clinic ___ [clinic number] - entered by ___ [Nurses’ name].” A review of the medical records for P5, P6, P7, P8, P9, P10, P11, P12, P13, P14, P15, P16, P17, P18, P19, P20, and P21, all from the first shift indicated that all 17 patients had a shortened hemodialysis treatment time of three hours. The medical records lacked evidence of a physician order for the shortened treatments on 04/26/25 for the above listed patients. This finding was reviewed and confirmed with S4 on 05/28/22 at 1:30 PM, who stated that the above listed patients had shortened treatments on 4/26/25. When asked, S4 was unable to provide any documentation of a physician’s order for the shortened treatments. S4 stated staff should have notified the nephrologist and obtained orders for the shortened treatment time for the patients on the first shift. Facility policy titled “Early termination or Arriving Late for Treatment,” published 11/07/22, stated, “... Treatment duration and frequency is prescribed by a patient’s physician and the facility expects that all patients will adhere to their prescribed treatment time schedule ... any discussion with the physician, must be documented in the patient’s medical record. ...” 37656 2. A review of P1’s Hemodialysis Orders, dated 04/24/25, stated, “Dialyzer: 160NRe Optiplux, Treatment time: 03:00 [3 hours]. 04/26/25 “Dialyzer: Nipro Cellentia 17H, Treatment time: 03:00.” Treatment Medications “... Diphenhydramine [allergy medication] [generic name for Benadryl] 50 mg [milligram] ORAL PRN [as needed] Anaphylaxis, start date 11/14/24 ...” A review of P1’s treatment flow sheet dated 04/24/25, stated, “early termination due to itchiness per NP [Nurse Practitioner] order; pt [patient] had red patches all over arms and back; ... oral Benadryl was given.” The Benadryl dose and route was not documented by the Registered Nurse on the “Medications” section of the flow sheet. Upon interview on 05/28/25 at 12:10 PM, S2 (Charge Nurse), stated that all medications given during dialysis should be documented in the medical record. Facility policy titled, “Medication Preparation Administration, published 02/06/23, stated, “... Documentation ... Medication Administration must be documented in the patient’s medical record. ...””

“MR-COMPLETE, ACCURATE, ACCESSIBLE CFR(s): 494.170 The dialysis facility must maintain complete, accurate, and accessible records on all patients, including home patients who elect to receive dialysis supplies and equipment from a supplier that is not a provider of ESRD services and all other home dialysis patients whose care is under the supervision of the facility. This Standard is not met as evidenced by: 51990 Based on a review of one of three medical records (Patient [P]2) regarding a suspected dialyzer (a device used for hemodialysis) reaction, staff interviews, and a review of facility documents, it was determined that the facility failed to ensure that the patient’s medical record is complete and accurate. Findings include: On 05/28/25 at 10:00 AM, during an interview, Staff S2 (Charge Nurse) stated that on 04/25/25, P2 experienced itching during hemodialysis, leading to a suspected dialyzer reaction. A review of P2’s medical record revealed the following: The Treatment Sheets dated 04/25/25 and 04/28/25 included: The Hemodialysis Orders dated, 04/25/25 and 04/28/25, documented the use of an Optiflux 180NRe dialyzer and listed the patient’s allergies as “Penicillins [sic]” with “No Known Food Allergies.” The prescribed duration for hemodialysis was four hours. The Treatment Sheet, dated 04/25/25, contained no documentation of itching complaints in the treatment data during hemodialysis from 3:36 PM to 6:32 PM, an approximately three-hour session. The Nursing Evaluation Note, documented at 7:19 PM, stated: “pt [patient] with generalized pruritus [itching], ... tx [treatment] terminated early.” The documentation of itching occurred 47 minutes after the dialysis session ended. During an interview on 05/28/25 at 11:53 AM, S1 (Clinic Manager), confirmed there was no documentation of itching during the hemodialysis treatment on the flowsheet. S1 stated that P2 complained of itching and requested early termination of the treatment. S1 also stated that the physician had ordered a change to a Nipro dialyzer for the next treatment due to the suspected reaction. However, the Hemodialysis Orders, dated 04/28/25, continued to list the Optiflux dialyzer. The Treatment Sheet dated 04/28/25, confirmed that an Optiflux dialyzer was still in use. The treatment data documented no complaints of itching during the session from 3:58 PM to 7:38 PM. In a follow-up interview on 05/28/25 at 1:15 PM, S4 (Director of Operations) stated that no physician had ordered a change to the Nipro dialyzer, contradicting S1’s earlier statement. S4 confirmed that the Optiflux dialyzer remained in use on 04/28/25. At 1:30 PM, S1 stated that the patient’s itching was a reaction to an antibiotic prescribed at the nursing home, not to the dialyzer. However, S1 was unable to name the antibiotic. S1 mentioned that P2 had informed staff of the reaction. As of the survey date, the antibiotic remained unidentified, and the allergy was not documented, 33 days after the incident. Further review of P2’s medical record revealed that the Monthly Nursing Progress Note for April 2025 contained no documentation of a suspected dialyzer reaction, and the Provider Basic Note documented by the Advance Practice Nurse dated 05/07/25 stated: “Overview: ... Patient is stable. Patient has no complaints ...” There was no mention of a suspected dialyzer reaction. At 1:40 PM on 05/28/25, S1 confirmed that neither the Registered Nurse nor the Advanced Practice Nurse had documented the suspected dialyzer reaction in the medical record. Facility policy titled, “Dialyzer Reaction,” published 07/01/24, stated, “... Signs and Symptoms ... Anaphylactic Reaction- Severe: Type A ... Occurs within 5-30 minutes of HD initiation: ... Pruritus, Urticaria ... 4. Obtain order to change dialyzer ... Treating Dialyzer Membrane Reaction while on Hemodialysis ... 11. Document the event in the patient’s treatment record. Document allergy in the in the treatment record ... Guidance on Converting to an Alternate Dialyzer ... If the patient’s documented reaction to Optiflux was not severe, such as headache or itching: Convert to the FX CorAL ...””