Davita Holmdel Dialysis

“DIALYS PROPORT-MONITOR PH/CONDUCTIVITY CFR(s): 494.40(a) 5.6 Dialysate proportioning: monitor pH/conductivity It is necessary for the operator to follow the manufacturer’s instructions regarding dialysate conductivity and to measure approximate pH with an independent method before starting the treatment of the next patient. This Standard is not met as evidenced by: 39223 Based on observation, staff interview, and review of facility documents, it was determined that the facility failed to ensure that conductivity testing is completed in accordance with facility policy and manufacturer instructions for use (IFU) for one of two dialysate conductivity tests. Findings include: On 5/13/24 at 11:19 AM, Staff (S)5, a Registered Nurse, obtained a sample of dialysate from the hemodialysis machine located in Station 9 and brought it to a designated dirty area counter. S5 then obtained a Myron-L D-1 Meter (The meters are used to check the conductivity to ensure quality and safety of the dialysate before it is use in dialysis treatment of patients) and rinsed out the meter cell cup with Reverse Osmosis (RO) water. S5 then poured the dialysate sample into the meter cell cup, moved the plunger up and down four times and pressed the black button. S5 then opened the bottom of the machine, reached into the machine, and recalibrated the meter. S5 then emptied out the dialysate from the meter cell cup and rinsed it with RO water. S5 filled the Myron-L meter cell cup with dialysate and moved the plunger up and down four times. S5 then opened the bottom of the Myron-L D-1 meter a second time, reached into the machine, and recalibrated the meter. S5 moved the plunger up and down four times, disposed of the dialysate sample and then refilled the cell cup with dialysate. S5 pressed the black button three times and obtained a conductivity result of 13.8. During an interview conducted at 11:28 AM, S5 stated that when he/she removed the bottom of the meter, he/she would then recalibrate the meter. S5 stated that he/she should have used the CalRite 14.0 solution instead of the dialysate when he/she recalibrated the machine. After the interview, S5 recalibrated the Myron-L with the CalRite 14.0 solution, and tested a new dialysate sample obtained from Station 9 according to facility policy. The undated Myron L Company Operating Instructions for the Single Range Dialysate Meter, provided by S1, the Facility Administrator, stated, “... USING YOUR METER ... 1. Fill the cell cup to just above the top electrode with a sample of the dialysate you want to test. The dipper end of the cell plunger will deliver just the right amount. ... 2. Drop the plunger into the cell cup. Lift it about half way out of the cell and drop it back in three or four times. Discard the sample. ... 3. Repeat steps 1 and 2 at least three times. 4. Take another sample, drop in the plunger and press the black button. When the pointer stops, IMMEDIATELY read and release the button. 5. Repeat step 4 twice and record the last reading. ...” Facility policy titled, “Calibration Check and Calibration of Portable Myron L Conductivity Meter (D-1),” revised October 2022, stated, “... NOTES: This procedure is to be performed prior to daily use or whenever inaccurate readings are suspected. ... Procedure ... 3. Collect a sample of the 14 millimhos standard solution and place in the meter cell cup. Next place plunger in the meter cell cup and test the sample. If the D-1 meter indicates the value shown on the standard solution bottle the meter is calibrated. ...””

“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: 37656 Based on a review of facility documents and staff interview, it was determined that the facility failed to ensure that three of three Portable Myron L Conductivity Meters (D-1) are checked and calibrated prior to daily use. The meters are used to check the conductivity to ensure quality and safety of the dialysate before it is use in dialysis treatment of patients. Findings include: On 5/14/24, a review of the Conductivity Calibration log of the Portable Myron L Conductivity Meter (D-1) indicated that all three meters were not checked and calibrated on the following days: 3/9/24 and 4/29/24. In a interview on 5/14/24 at 2:30 PM, Staff (S)11, Biomedical Technician, stated that the meters should be check everyday prior to daily use. A review of the facility policy and procedure titled, “Calibration Check and Calibration of Portable Myron L Conductivity Meter (D-1),” revised October 2022, stated, “... This procedure is to be performed prior to daily use or whenever inaccurate readings are suspected. ...””

“PA-IDT MEMBERS/RESPONSIBILITIES CFR(s): 494.80 The facility’s interdisciplinary team consists of, at a minimum, the patient or the patient’s designee (if the patient chooses), a registered nurse, a physician 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 of his or her needs. The comprehensive assessment must be used to develop the patient’s treatment plan and expectations for care. This Standard is not met as evidenced by: 48966 Based on medical record review, review of facility policy, and staff interviews, it was determined that the facility failed to ensure that the Physician completes a comprehensive assessment prior to developing a patient Plan of Care for five of seven patients (Patient (P)3, P4, P5, P6, and P7). Findings include: Medical Record (MR) 3 was reviewed and revealed a Plan of Care (PoC), dated 5/8/24 signed by the Registered Nurse, the Registered Dietitian, the Social Worker and the Physician. The PoC lacked evidence that the Physician completed a comprehensive assessment and contributed to the PoC prior to the meeting. MR5 was reviewed and revealed a PoC, dated 2/6/24 signed by the Registered Nurse, the Registered Dietitian, the Social Worker, and the Physician. The PoC lacked evidence that the Physician completed a comprehensive assessment and contributed to the PoC prior to the meeting. During an interview on 5/14/24 at 1:31 PM, Staff (S)2, the Manager of Clinical Services, confirmed there was no progress notes or comprehensive assessments completed by the Physician for the P3 and P5. S2 confirmed the Comprehensive Assessments were completed by the Nurse Practitioner for P3 and P5. 39223 On 5/14/24 at 2:23 PM, a review of MR4 was completed with S3, Clinical Coordinator, and revealed a Plan of Care (PoC) dated 4/24/24. A comprehensive note by the Physician, dated 4/29/24. This was after the PoC meeting occurred. S3 confirmed that there was a lack of documented evidence that a comprehensive assessment was completed prior to the PoC meeting on 4/24/24. 49828 A review of MR2, in the presence of Staff (S)2, Manager of Clinical Services, was completed. The Plan of Care (PoC), dated 12/22/23 lacked documented evidence of a physician’s comprehensive assessment prior to the PoC. During an interview with S2, it was confirmed that there was a lack of documented evidence that a comprehensive assessment was done prior to the PoC. A review of MR6, in the presence of S2 was completed. The PoC, dated 12/26/23 lacked documented evidence of a physician’s comprehensive assessment prior to the PoC. During an interview with S2, it was confirmed that there was a lack of documented evidence that a comprehensive assessment was done prior to the PoC. A review of MR7, in the presence of S2 was completed. The PoC, dated 3/15/24 lacked documented evidence of a physician’s comprehensive assessment prior to the PoC. During an interview with S2, it was confirmed that there was a lack of documented evidence that a comprehensive assessment was done prior to the PoC. A review of the facility policy titled, “Interdisciplinary Team (IDT) Patient Assessments And Plan Of Care,” revised in July 2023, stated, “ ... 2. 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 ... Plan of Care: Complete patient plan of care and plan of care meeting within 15 days of the completion of the reassessment ...” N.J.A.C. 8.43A-24.13(c)”

“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: 39223 Based on medical record review, staff interview, and review of facility documents, it was determined that the facility failed to ensure that : 1) Interventions are clearly determined by the IDT (interdisciplinary team) during the Plan of Care (PoC) meeting; and 2) Elevated blood pressures are reported to the physician during treatments for one of two unstable patients. Findings include: A review of Medical Record (MR)1 indicated an order for three hour In-center hemodialysis treatments, three days per week, with a target weight of 75.5 kilograms (kg) starting on 4/26/24. MR1 also contained a Plan of Care, dated 5/2/24, under the heading of “Fluid/BP [Blood Pressure]” which stated, “... Current Goals Meet and maintain a post-weight in relation to ordered target weight to avoid complications related to hyper- or hypo-volemic states. Time frame 3 months Long-Term Intervention(s) Implement fluid management care activities as appropriate ...” Review of the Treatment Details Report revealed the following: On 4/30/24, hemodialysis treatment started at 2:29 PM with a BP of 164/89. Treatment BPs were as follows: 2:32 PM - BP 172/85 3:02 PM - BP 141/82 3:32 PM - BP 161/77 4:02 PM - BP 153/82 4:32 PM - BP 179/90; comment, “... BP elevated by 26 points. Pt [patient] has no c/o [complaints]. Will continue to monitor closely. ...” documented by the RN. 5:02 PM - BP 162/93; comment, “... BP dropped by 17 points. Pt has no c/o. Will continue to monitor closely. ...” documented by the RN. 5:31 PM - BP 184/95; comment, “... Treatment terminated. Patient blood returned without complications ...” documented by the RN. A post-treatment blood pressure from the nurse assessment was documented for 6:00 PM as 171/92. On 5/4/24, hemodialysis treatment started at 2:30 PM with a BP of 162/83. Treatment elevated BPs were as follows: 3:34 PM - BP 172/98 4:04 PM - BP 197/103 4:34 PM - BP 179/90 5:04 PM - BP 169/91 5:32 PM - BP 175/160; comment, “... DBP [diastolic blood pressure] high; will recheck 5:33 PM - BP 179/96; comment, “... Treatment terminated ...” A post-treatment blood pressure from the nurse assessment was documented as 192/87 at 5:45 PM. On 5/9/24, hemodialysis treatment started at 3:17 PM with a BP of 184/96. Elevated BPs during hemodialysis treatment were as follows: 3:34 PM - BP 188/100 4:04 PM - BP 155/92 - comments, “... BP [blood pressure] dropped. Pt has no c/o [complaints]. Will monitor.” 4:34 PM - BP 166/94 5:04 PM - BP 178/92 - 5:34 PM - BP 194/94 - comment, “... BP elevated. Pt has no co [complaints]. Will continue to monitor closely.” 6:04 PM - BP 178/99 - comment, “... BP improved. Pt resting without distress. Will continue to monitor closely.” 6:16 PM - BP 177/105 A post-treatment blood pressure from the nurse assessment was documented as 188/98 at 6:29 PM. The above was reviewed on 5/14/24 at 2:10 PM with Staff (S)2, Manager of Clinical Services. S2 was unable to identify documented fluid management care activities that were implemented from the Plan of Care, dated 5/2/24. S2 confirmed that MR1 did not contain documentation indicating the physician was notified of the elevated blood pressures. During an interview on 5/14/24 at 2:33 PM, S3, the Clinical Coordinator, stated that the above PoC did not document interventions related to the patient’s elevated blood pressures. S3 stated that when the patient’s blood pressure was elevated, the physician should be made aware and it should be documented in the post assessment or in clinical notes. Facility policy titled, “Interdisciplinary Team (IDT) Patient Assessment and Plan of Care,” revised July 2023, stated, “... PLAN OF CARE: 8. 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 ...” Facility policy titled, “Pre-Intra-Post Treatment Data Collection, Monitoring, and Nursing Assessment,” revised April 2024, stated, “... Abnormal Findings ... Blood Pressure: Pre-dialysis: Systolic greater than 180 mm/Hg [millimeters of mercury] or less than 90 mm/Hg. Diastolic greater than or equal to 100 mm/Hg or less than 50 mm/Hg. Blood Pressure: Intradialytic: Systolic greater than 180 mm/Hg or less than 90 mm/Hg. Diastolic greater than or equal to 100 mm/Hg or less than 50 mm/Hg. ... Blood Pressure Post Treatment: ... Sitting systolic BP for patient’s that cannot stand: Sitting systolic BP greater than 140 mm/Hg or less than 90 mm/Hg. Sitting diastolic BP greater than 90 mm/Hg or less than 50 mm/Hg. ...” N.J.A.C. 8:43A-24.13(c)”

“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 observation, staff interviews, and a review of facility documents, it was determined that the Medical Director failed to ensure that: 1) pre-drawn heparin syringes are labeled in accordance with facility policy and procedure for two of two observations of medication administration; and 2) a monthly progress note is entered into the patient’s medical record by the physician for five of seven medical records reviewed (Patient (P)2, P3, P5, P6, and P7) according to facility policy. Findings include: 1. On 5/14/24 at 9:33 AM, during an observation of the discontinuation of hemodialysis via a Central Venous Catheter (CVC) in Station 9, two labeled 3 ml (milliliter) syringes containing a clear liquid were observed being instilled into the catheter lumens of P9 post (after) treatment. The two syringes each contained a white label affixed that indicated they contained Heparin Sodium (an anticoagulant) 1,000 units/ml. Both syringes contained the following documentation: name of the medication, route, dosage, name of the patient and date. The initials of the person who prepared the medication and the time prepared was not indicated on the labeled Heparin syringes. During an interview at 9:44 AM, Staff (S)6, a Registered Nurse, confirmed the Heparin syringes should have the time prepared and initials of the person who prepared the medication on the label. S6’s personnel file was reviewed and indicated that the Annual Skills Checklist was completed on 5/7/24, which included the storage, preparation and administration of medication. On 5/14/24 at 10:58 AM, during an observation of the initiation of hemodialysis, in Station 15, a labeled Heparin bolus syringe was administered to P10. The Heparin bolus syringe contained the following documentation: name of the medication, route, dosage, name of the patient and date. The initials of the person who prepared the medication and the time prepared were not indicated on the Heparin syringe labels. During an interview at 11:27 AM, S7, a Registered Nurse, explained that S6 prepared the medication and was not sure what time he/she drew up the medication. S7 confirmed the Heparin bolus syringe should have the time prepared and initials of the person who prepared it on the label. S7’s personnel file was reviewed and indicated that the Annual Skills Checklist was completed on 5/2/24, which included the storage, preparation and administration of medication. A review of the facility policy titled, “Medication Policy,” revised October 2023, stated, “... Policy: ... 20. If medications are prepared and administered immediately, by the same licensed nurse teammate, the medications do not need to be labeled. If the medication is not immediately administered or is to be administered by another teammate, the medication must be labeled with the patient name, name of medication, date, time prepared, dose and initials of the teammate preparing the medication ...” 2. A review of P3’s medical record for physician monthly progress notes, dated 11/23 through 4/24 was completed. The medical record did not contain a physician monthly note for 11/23, 12/23, 1/24, 3/24, and 4/24. A review of P5’s medical record for physician monthly progress notes dated 11/23 through 4/24 was completed. The medical record did not contain a physician monthly note for 11/23, 12/23, 1/24, 3/24, and 4/24. During an interview on 5/14/24 at 1:31 PM, S2, the Manager of Clinical Services, confirmed that no monthly progress notes by the physician were documented in the electronic medical record for P3 and P5 for 11/23, 12/23, 1/24, 3/24, and 4/24. During an interview on 5/14/24 at 1:35 PM, S1, the Group Facility Manager, stated the physician typically makes rounds on Mondays and relies on the Nurse Practitioner to document information in the progress notes in the computer. 49828 On 5/14/24 at 1:20 PM, Physician Notes dated 11/23 until 4/24 for P2 were reviewed with S2, Manager of Clinical Services. The review revealed a lack of documented evidence that monthly comprehensive assessments or monthly progress notes were entered into the medical record for the following months: 11/23, 12/23, 1/24, 2/24, 3/24, and 4/24. During an interview at the time of review, S2 confirmed there was a lack of documented evidence that a comprehensive assessment or a monthly progress note was entered into the medical record during the above listed months. On 5/14/24 at 1:25 PM, Physician Notes dated 11/23 until 4/24 for P6 were reviewed with S2. The review revealed a lack of evidence that monthly comprehensive assessments or monthly progress notes were entered into the medical record by a physician for the following months: 11/23, 12/23, and 1/24. During an interview at the time of review, S2 confirmed there was a lack of documented evidence that a comprehensive assessment or a monthly progress note was entered into the medical record during the above listed months. On 5/14/24 at 1:30 PM, Physician Notes dated 11/23 until 4/24 for P7 were reviewed with S2. The review revealed a lack of evidence that monthly comprehensive assessments or monthly progress notes were entered into the medical record by S10, P7’s nephrologist, for the following months: 11/23, 1/24, 2/24, and 3/24. During an interview at the time of review, S2 confirmed there was a lack of documented evidence that a comprehensive assessment or a monthly progress note was entered into the medical record during the above listed months. During an interview on 5/15/24 at 12:46 PM, S10, Alternate Medical Director/Nephrologist, stated that he/she was unaware the comprehensives were not being done by a physician monthly. S10 stated, patients are often seen in the nephrologist’s office monthly and patient’s assessments are documented there. S10 confirmed the documentation pertaining to the office visits were not documented in the facility’s medical record. Per S10 some patients were absent for treatments on the days the physicians came to the facility. The “Medical Staff Bylaws,” effective 8/1/21 stated, “... Ensure that there are timed, dated, and signed comprehensive care notes in each of his or her patients medical record at least every 30 days that reflect the monthly face to face evaluation and examination ...” The “Progress Note Policy,” revised October 2023 stated, “... The attending Nephrologist is required to record progress notes at least monthly and for any clinical event, which must be recorded in a timeframe that provides other interdisciplinary team members with an up-to-date picture of the status of the patient at all times...” N.J.A.C. 8:43A-24.4(a) N.J.A.C. 8:43A-24.13(d)”