Davita Hamilton Street Dialysis

“Dialysis Emergency Equipment CFR(s): §494.62(b)(9) Condition for Coverage: [(b) Policies and procedures. The dialysis facility must develop and implement emergency preparedness policies and procedures, based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, and the communication plan at paragraph (c) of this section. The policies and procedures must be reviewed and updated at least every 2 years. At a minimum, the policies and procedures must address the following:] (9) A process by which the staff can confirm that emergency equipment, including, but not limited to, oxygen, airways, suction, defibrillator or automated external defibrillator, artificial resuscitator, and emergency drugs, are on the premises at all times and immediately available. This Standard is not met as evidenced by: 49828 Based on observation of one peritoneal dialysis (PD) home training emergency equipment box, staff interview, and review of facility documents, it was determined that the facility failed to ensure that the emergency evacuation box contained all the necessary equipment and information in the event of an emergency in accordance with facility policy. Findings include: On 4/10/24 at 1:43 PM, the contents of the emergency evacuation box were reviewed and compared to the inventory checklist titled, “Emergency Evacuation Kit Checklist.” The following items on the above reviewed documents were not present in the evacuation box: Of an unidentified “Desired Quantity” according to the Checklist for Minicabs or Walnut caps, there were no Minicabs or Walnut caps present in the Evacuation box. Of the expected one 1.5 % (percent) Ultra 2 L (liters). There were no 1.5 % Ultra 2 L present in the Evacuation box. Of the expected six home Peritoneal Dialysis patient treatment orders, and emergency contacts there were no current patient treatment orders, or emergency contacts. A review of the patient treatment orders and emergency contact information present in the box revealed that the information was last printed 4/5/2023. This was not in accordance with facility policy which requires updates and replacement of patient information monthly. On 4/10/24 at 1:50 PM, Staff (S) 9, a Registered Nurse, stated the above missing items were not available for replacement because they must be ordered. S9 stated he/she spoke with the S1, the Facility Administrator (FA), to have the Minicabs, and 1.5% Ultra 2L ordered 4/10/24. The copy of patient’s treatment orders and medications lists were reviewed with S9 who stated that the information was outdated. S9 stated he/she is new to the home PD program and did not know that he/she should be checking the evacuation boxes contents. The “Facilities Emergency Management Plan,” revised April 2024, stated, “ ... 2. The contents of the evacuation kit(s) will include at a minimum, enough supplies to provide care for a full shift of patients, including home patients, likely to be present in the facility at any given time ... c. Refer to Emergency Evacuation Kit Checklist ... 6. Each evacuation kit(s) should contain: a. Copy of each patient’s treatment orders and medication list. FA (Facility Administrator) or designee will verify patient information is updated and replaced at least monthly ...”. N.J.A.C 8:43A-15.1(d)”

“MIXING SYSTEMS-PERM RECORD/VERIF TEST CFR(s): 494.40(a) 5.4.4.1 Mixing systems: perm record/verification testing In addition to container labeling, there should be permanent records of batches produced. These records should include the concentrate formula produced, the volume of the batch, the lot numbers of powdered concentrate packages, the manufacturer of the powdered concentrate, the date and time of mixing, any test results, the person performing the mixing, the person verifying mixing and test results, and the expiration date (if applicable). 6.4.1 Mixing systems Acid and bicarbonate concentrates may be tested by using conductivity or by using a hydrometer. Concentrates should not be used or transferred to holding tanks or distribution systems until all tests are completed. The test results and verification that they meet all applicable criteria should be recorded and signed by the individuals performing the tests. This Standard is not met as evidenced by: 39228 Based on staff interview and a review of facility documents, it was determined that the facility failed to ensure that the catalog number for the Granuflo dry acid that is mixed at the facility, on one of two Granuflo Batch Production Records, is documented in accordance with the manufacturers table specified in the facility policy. Findings include: On 4/10/24, Staff (S) 2, the Biomedical Technician, provided two “Granuflo (132 Gallon) Batch Production Records” forms dated 3/18/24. One form indicated a 2K (potassium) Granuflo batch was mixed and the other form indicated that a 3K Granuflo batch was mixed. Both forms were completed, initialed and signed by S6, a Patient Care Technician. The forms also contained a signature from S4, a Registered Nurse. Review of both records revealed that the section titled “Granuflo Dry Acid Catalog Number” contained the same documented catalog number “OFD2251-3B” for both the 2K batch and for the 3K batch. The catalog number documented on the Granuflo Batch Production Record, dated 3/18/24 for the 3K batch, did not match the catalog number specified in the “Manufacturer’s Table” in the facility policy. S2 reviewed the Batch Production Record and stated that the staff member incorrectly documented the 2K batch catalog number on the form but mixed the batch correctly and in accordance with the 3K specific gravity ranges. Upon interview at 1:50 PM, S2 stated that the binder located on the treatment floor that contained the Granuflo Batch Production Records forms had the following prefilled areas in the Part 1 section: Granuflo Dry Acid Catalog Number, the facility name and number, the Dissolution Tank Serial Number, the batch size and the number of boxes to be used. Upon discovery, S2 stated that he/she spoke with the staff members who completed the form and that the form was prefilled because most of the information in Part 1 is consistent with each batch. Upon discovery of the prefilled forms, S2 removed them from the binder and then replaced them with forms that were not prefilled. S2 stated that he/she then educated the staff members to fully complete the form and not to prefill any areas. Review of S6’s training records with S7, Manager of Clinical Services, indicated that S6 last completed “Mixology-All About Dialysate Mixing Curriculum” training on 11/2/22 and S4 completed it on 11/27/23. Review of facility policy and procedure titled, “Granuflo Concentrate Dissolution Unit,” last revised April 2023, stated, “...Purpose: To verify that the Granuflo Concentrate Dissolution Unit (Granuflo) is operated to produce liquid acid concentrate from commercially packaged dry powder in a safe and fully documented process that is consistent with instructions given by the manufacturer of the device. ... Policy: ... 6. A Granuflo Batch Production Record is fully completed for each batch of liquid concentrate that is produced. ... Specific Gravity Ranges ... Catalog Number ... 3K ... OFD3251-3B ... 22 degrees C [Celsius] to 26 degrees C Low 1.192 High 1.204 ...” N.J.A.C 8:43A-24.10(a)(5)”

“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: 37656 Based on observation and staff interview, it was determined the facility failed to ensure that a defect free physical environment is maintained at all times. Findings include: During a tour conducted on 4/10/24 at 10:30 AM in the presence of Staff (S) 2, Biomedical Technician, the door sweep installed on the exterior doors of the main storage room was damaged and torn, leaving a visible gap. This gap between the door and floor could allow the entrance of insects and vermin to the interior of the building. During an interview at the time of discovery, S2 stated he/she will discuss the issue with management to fix the problem. N.J.A.C 8:43A-17.3(l)”

“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 observations, staff interviews and review of manufacturers instructions for use (MIFU) for Minncare HD Residual Test Strips, it was determined that the facility failed to ensure: 1) the equipment in the water treatment room is maintained, and 2) that expired Minncare HD Residual Test Strips are not available for use in the water room in one of one bottle. Findings include: 1. On 4/10/24 at 10:30 AM, during tour of the Water Treatment Room in the presence of Staff (S) 2, Biomedical Technician, the following was observed: The Dry Acid Dissolution Unit (the equipment use for mixing acid), contained dry white residues and dust on top of the machine and on the lid. The wall containing two valves used for transferring acid to the holding tank contained a large amount of a thick build up of solidified white substances. During an interview on 4/10/24 at 10:35 AM, S2 stated that the staff member who mixes the acid is responsible for cleaning the equipment and that it should be cleaned immediately after mixing to prevent build up of acid residues. 39228 2. On 4/10/24 at 10:31 AM, during a tour of the Water Room, conducted with S2, the Biomedical Technician, an open bottle of Minncare HD Residual Test Strips, that contained multiple testing strips, had a printed expiration date of 3/19/24 on the bottle. Upon interview at the time of discovery, S2 stated that the strips had not been used since they expired and he/she was not sure why the testing strips were available for use in the Water Room. S2 stated that staff members who conducted the Minncare testing use a test strip bottle that is located on the treatment floor. At 3:09 PM, an interview was conducted with S6, a Patient Care Technician (PCT), who confirmed that he/she performs Minncare testing at the facility. S6 provided an open bottle of Minncare HD Residual Test Strips that he/she stated he/she keeps on the treatment floor and verified that the testing strips were not expired. S6 stated that he/she checks the bottle’s expiration date prior to utilizing the testing strips. A review of the RO (reverse osmosis) Unit Chemical Disinfection logs for 3/19/24 through 3/27/24, indicated that testing for chemical residue after disinfection was conducted on 3/21/24, 3/28/24, and 4/4/24. However, it was unable to be determined if the expired testing strips were used to test for residual because there was no expiration date for the Minncare HD testing strips documented on the form. Review of the MIFU for the Minncare HD Residual Test Strips stated, “Caution: Read Important Storage & Use Information. ... Failure to store test strips properly will result in inaccurate readings. When stored and used properly the test strip can indicate residual MINNCARE HD Disinfectant as low as 1 part per million ...” N.J.A.C. 8:43A-24.11(c)”

“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: 37656 Based on review of the medical record of one of two unstable patients (Patient (P)2), review of facility policy, and staff interview, it was determined that the facility failed to ensure that all members of the interdisciplinary team complete a comprehensive assessment of each patient’s individualized needs for the Plan of Care. Findings include: A review of Medical Record (MR) 2 lacked evidence of a physician’s comprehensive assessment for the patient’s needs. The Plan of Care meeting, dated 4/1/24, determined that P2 was unstable due to hospitalizations. A Physician’s comprehensive note was written on 4/11/24, 10 days after the Plan of Care Meeting. In an interview on 4/11/24 at 11:00 AM, Staff (S)4, Clinical Coordinator, stated there was no comprehensive note from the physician because P2 did not go to the doctor’s clinic. S4 also stated that the physician does not see P2 in the dialysis facility, and that he/she sees P2 at his/her clinic only. Upon interview on 4/12/24 at 10:30 AM, P2 stated that he/she only goes to the doctor’s office to see the doctor. P2 stated that the doctor never came to the dialysis unit when he/she was receiving dialysis treatment. P2 last saw the doctor on 4/11/24 at the doctor’s clinic, and prior to April, he/she last saw his/her doctor in December 2023. P2 stated that he/she was dialyzed at the facility when he/she was in the rehabilitation facility for three weeks, and could not go to his/her doctor because of transportation. P2 stated, he/she drives to the facility. A review of the 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 assessment 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 evidence-based professionally- accepted clinical practice standards ... 14. The patient’s plan of care will be completed by facility’s interdisciplinary team, including patient or personal representative and be signed by team members including the patient or the patient’s personal representative. ... 21. Implementation of assessments and plans of care are detailed in table below: Monthly (unstable patients), Assessment - Monthly until patient is determined by interdisciplinary team to be stable. Plan of Care - Complete patient plan of care meeting within 15 days of the completion of the re-assessment and POC (Plan of Care) ...” N.J.A.C. 8:43A-24.13(d)”

“POC-VASCULAR ACCESS-MONITOR/REFERRALS CFR(s): 494.90(a)(5) The interdisciplinary team must provide vascular access monitoring and appropriate, timely referrals to achieve and sustain vascular access. The hemodialysis patient must be evaluated for the appropriate vascular access type, taking into consideration co-morbid conditions, other risk factors, and whether the patient is a potential candidate for arteriovenous fistula placement. This Standard is not met as evidenced by: 48966 Based on observations, staff interview, and a review of facility documents, it was determined that the facility failed to ensure that the staff perform proper skin disinfection of the access site prior to initiating the dialysis treatment per facility policy and procedure in one of two observations of the initiation of dialysis through an arteriovenous graft/fistula (AVG/AVF). Findings include: On 4/10/24 at 11:25 AM, Staff (S)3, a Patient Care Technician (PCT), initiated dialysis through a patient’s AVG (arteriovenous graft) at Station 4. After cleansing each site of the AVG with alcohol pads in a circular motion, S3 applied betadine for 15 seconds in a circular motion to each site and allowed the betadine to dry for one minute twenty-five seconds prior to cannulation (the action of inserting a metal tube into the body to draw off fluid or introduce medication). This was not in accordance with the facility policy and procedure. Upon interview at 11:53 AM on 4/11/24, S3 stated he/she should clean the sites with betadine for 20 seconds and allow to dry for 60 seconds. A review of S3’s personnel record indicated the PCT skills checklist for cleansing cannulation sites were demonstrated on 2/26/24 and satisfactory performance by a new teammate signed off on 3/6/24. A review of the facility policy titled, “AV Fistula Or Graft Cannulation With Nipro Or Medisystems Safety Fistula Needles (SFN) And Administration of Heparin Loading Dose,” revised October 2022, stated, “... Procedure 11. While maintaining aseptic technique, cleanse the site by applying skin antiseptic using a circular motion, moving from the center out and allow to dry. (For contact and dry time refer to the table above) ... Povidone Iodine ... Effective Contact Time 30 seconds, Air Drying Time 2 minutes ...” N.J.A.C. 8:43A-24.8(b)”

“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: 48966 Based on review of one of two medical records (MR) of a patient designated as unstable (Patient (P)1), review of facility documents, and staff interview, it was determined that the facility failed to ensure all patient’s Plans of Care (POC) are completed by the interdisciplinary team (IDT) and signed by the team members and patient/patient’s designee. Findings include: A review of MR 1 was conducted and the following was revealed: P1 was made unstable during the Plan of Care meeting dated 1/24/24. The “Patient Plan of Care” lacked evidence of the Medical Provider’s signature. A February Plan of Care meeting was held on 3/4/24. The Registered Dietician, Master Social Worker, Medical Provider and the signature of P1 were missing on the Plan of Care. P1’s medical record revealed the March 2024 Plan of Care was not completed and present in the chart. Upon interview on 4/11/24 at 11:18 AM, Staff (S)4, Clinical Coordinator, stated that the Plan of Care that was due on 3/29/24 was not completed. S4 stated the new Social Worker started on 2/27/24, and did not complete the Comprehensive Assessment. S4 was not sure why the signatures were missing on the February 2024 Plan of Care. S4 stated the Physician was not present for the Care Plan meeting in January or February of 2024. Upon interview on 4/11/24 at 11:46 AM, S1, the Facility Administrator, stated that the March Plan of Care was not done due to the change in Social Workers. A review of the facility policy titled, “Interdisciplinary Team (IDT) Patient Assessment And Plan Of Care,” revised in July 2023, states, “... 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 assessment 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 evidence-based professionally- accepted clinical practice standards ... 14. The patient’s plan of care will be completed by facility’s interdisciplinary team, including patient or personal representative and be signed by 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. ... 21. Implementation of assessments and plans of care are detailed in table below: Monthly (unstable patients), Assessment- Monthly until patient is determined by interdisciplinary team to be stable. Plan of Care - Complete patient plan of care meeting within 15 days of the completion of the re-assessment and POC (Plan of Care) ...” N.J.A.C 8:43A-24.13(b)”

“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: 37656 Based on medical record review, interviews, and review of facility documents, it was determined that the facility failed to ensure that patients see a medical practitioner at least monthly and notes are completed by the physician for one of one patient (Patient (P)2). Findings include: A review of P2’s medical record lacked documented evidence of a physician monthly progress note for December 2023, January, February, and March 2024. P2 was under the care of Staff (S)11, a Nephrologist. Upon interview on 4/11/24 at 9:45 AM, Staff (S)4, a Registered Nurse, stated that P2 was hospitalized from 1/15/24 to 2/14/24, then hospitalized again from 4/1/24 to 4/3/24. Per S4, P2 goes to see S11 at the physician’s clinic every month, and since he/she was hospitalized, P2 was not able to go to the doctor’s office. S4 stated that S11 does not come to the dialysis unit to see P2. S4 confirmed there were no licensed practitioner notes in the months of January, February, and March, 2024. Upon interview on 4/12/24 at 10:30 AM, P2 stated that he/she will only visit the doctor at his/her office. P2 stated that the doctor never comes to the dialysis unit when he/she has received dialysis treatment. P2 last saw his/her doctor on 4/11/24 at the doctor’s office, and prior to April, P2 last saw his/her doctor in December 2023. P2 stated that he/she was dialyzed at the facility when he/she was in the rehabilitation facility after left foot surgery for three weeks, and could not go to his/her doctor because of transportation. P2 stated, he/she drives to the facility. P2 confirmed that his/her doctor did not see him/her in January, February, and March 2024. A review of the facility policy and procedure titled, “Interdisciplinary Team (IDT) Patient Assessment And Plan Of Care,” revised in July 2023, stated, “... 17. The dialysis facility will verify that all in-center hemodialysis patients are seen by an attending End Stage Kidney Disease (ESKD) physician at the dialysis facility while the dialysis treatment is being provided at least monthly and more often as clinically necessary or as required by local, state, or federal regulations and that the visit is documented in the progress note of the patient’s medical record ...” A review of the Medical Staff Bylaws, approved by Physician Council on May 20, 2021 and confirmed and adopted by Facility Governing Bodies Effective August 1, 2021, stated, “... Rounding and Documentation Requirements ... (a) Ensure patients are rounded on in compliance with ... (company’s name), ESRD Network, state and federal requirements. At minimum, this includes the following requirements (unless state law or a Public Health Emergency dictates otherwise) for: ... i. In-center and/or nocturnal patients: must be evaluated and examined by a nephrologist no less than once per month in-person in the facility while the patient is on dialysis; ... a. In the rare event that a monthly evaluation and examination cannot reasonably be conducted at the Facility, an evaluation and examination may take place at the patient’s home, in the physician’s office, or at another location that complies with ... (company’s name) policies, so long as the record of care is promptly incorporated into the Facility medical record ...” N.J.A.C. 8:43A-24.13(d)”

“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: 49828 Based on observation, staff interview, and a review of facility documents, it was determined that the Medical Director failed to implement the policy and procedure for the labeling of chlorine (bleach) solution for disinfecting. Findings include: On 4/10/24 at 9:48 AM, the following were observed during a tour of the hemodialysis treatment area: Two rectangular plastic boxes that contained a clear, yellow solution were present in the designated clean area located across from Station 9. One plastic box was labeled, “4/8/24 1:100 expired 4/9 @ 6pm” and a second plastic box was labeled, “4/8/24 1:10 expired 4/9 @ 6pm.” A clear, rectangular plastic box that contained a clear, yellow solution with six blue clamps submerged in the solution, was located in the designated dirty area across from Station 10. It did not contain a label indicating the contents of the plastic box. Upon interview at 9:59 AM, Staff (S)6, Patient Care Technician, stated the containers were bleach solutions, the solutions were made this morning, and that the buckets needed to have new labels placed to reflect that. Upon interview at 11:12 AM, S4, Clinical Coordinator, stated the unlabeled container in the dirty area across from Station 10 was a new bleach solution of 1:100 (one to one hundred) concentration that was made this morning. S4 confirmed that a chemical name and strength, date, time, initials, expiration date, and a HazCom label (Hazardous communications) should be present on the container. Facility policy titled, “Preparation of One to Ten 1:10 Bleach Solution,” revised October 2023, stated, “ ... with Indelible marking pen and label, label container with expiration date, time and initials. The solution is good for 24 hours only. ...” Facility policy titled, “Preparation of the One to One Hundred 1:100 Bleach Solution,” revised October 2023, stated, “... with Indelible marking pen and label, label container with expiration date, time and initials. The solution is good for 24 hours only. ... Additionally, the 1:100 bleach solution must also be, labeled with one to one hundred (1:100) bleach solution and permanent HazCom label ...” N.J.A.C. 8:42A-24.4(b)”