Fmc Salem Dialysis

“Roles Under a Waiver Declared by Secretary CFR(s): §403.748(b)(8), §416.54(b)(6), §418.113(b)(6)(C)(iv), §441.184(b)(8), §460.84(b)(9), §482.15(b)(8), §483.73(b)(8), §483.475(b)(8), §485.542(b)(7), §485.625(b)(8), §485.920(b)(7), §494.62(b)(7). [(b) Policies and procedures. The [facilities] 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 [annually for LTC facilities]. At a minimum, the policies and procedures must address the following:] (8) [(6), (6)(C)(iv), (7), or (9)] The role of the [facility] under a waiver declared by the Secretary, in accordance with section 1135 of the Act, in the provision of care and treatment at an alternate care site identified by emergency management officials. *[For RNHCIs at §403.748(b):] Policies and procedures. (8) The role of the RNHCI under a waiver declared by the Secretary, in accordance with section 1135 of Act, in the provision of care at an alternative care site identified by emergency management officials. This Standard is not met as evidenced by: 35949 Based on facility policy review, document review, and interview, it was determined that the facility failed to develop policies and procedures to include the role of the facility under a waiver declared by the Secretary, in accordance with section 1135 of the Social Security Act, in the provision of care and treatment at an alternate care site as part of the emergency preparedness plan. Findings include: A review of a facility policy titled, “Guidelines for Emergency Preparedness,” dated 07/03/2023, revealed, “The Centers for Medicare and Medicaid Services (CMS), the Department of Labor Occupational Safety and Health Act (OSHA) and other Federal and State agencies each have requirements intended to ensure that staff and patients are provided safe and sanitary environments as well as training in emergency preparedness to assist with ongoing safety.” Review of the facility’s undated emergency preparedness plan revealed no evidence of the development of a policy or procedure that included the facility’s role, under the declaration of an 1135 waiver, in providing care at an alternative care site. During an interview on 01/19/2024 at 2:42 PM, the Director of Operations confirmed the information in question was not included in the facility’s emergency preparedness plan and stated the required information must have fallen “through the cracks” during the most recent revision.”

“IC-ASEPTIC TECHNIQUES FOR IV MEDS CFR(s): 494.30(b)(2) [The facility must-] (2) Ensure that clinical staff demonstrate compliance with current aseptic techniques when dispensing and administering intravenous medications from vials and ampules; and This Standard is not met as evidenced by: 35949 Based on observation, interview, and facility policy review, it was determined that the facility failed to utilize an aseptic technique while preparing intravenous (IV) medications during 2 of 2 observations. Findings include: During an observation on 01/19/2024 at 9:08 AM of the medication preparation area at the nurses’ station with the Clinical Manager (CM), Registered Nurse (RN) #3 used a needle attached to a syringe to puncture the diaphragm of a medication vial. RN #3 failed to disinfect the diaphragm of the medication vial before puncturing the septum with the needle. The CM stated staff were trained to disinfect the diaphragm of the medication vial before puncturing it with a needle attached to a syringe while preparing medications for administration. During an observation on 01/19/2024 at 9:22 AM, RN #3 used a needle attached to a syringe to puncture the diaphragm of a medication vial. RN #3 failed to disinfect the diaphragm of the medication vial before puncturing the septum with the needle. RN #3 confirmed she did not disinfect the diaphragm of the medication vial before puncturing it with a needle attached to a syringe. She stated that she had been trained to use an alcohol pad to disinfect the diaphragm. Review of a facility policy titled, “Medication Preparation and Administration,” dated 02/06/2023, revealed, “Infection Control” included “Cleanse the diaphragm of a vial with alcohol prior to accessing the vial. If the vial is a multidose vial, cleanse the diaphragm with a new alcohol pad each time the vial is accessed with a needle using friction and 70% [percent] alcohol. Allow to dry before inserting a device into the vial.” 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: 35949 Based on observation, interview, manufacturer’s directions for use (DFU) review, and facility procedure review, it was determined that the facility failed to adhere to the bloodline manufacturer’s DFU during dialysis treatments by not maintaining the arterial drip chamber fluid levels at 85 percent (%) to 95% full and by not maintaining the venous drip chamber fluid levels at 65% to 75% full during 3 of 3 observations. Findings include: Observation of the hemodialysis treatment area on 01/16/2024 from 10:45 AM to 11:30 AM, revealed the arterial drip chamber fluid levels were less than (<) 85% full in Stations 2, 3, 4, 5, 6, 10, 13, and 14, and the venous drip chamber fluid levels were greater than (>) 75% full in Stations 2, 3, 4, 5, 6, 10, and 14. Observation of the hemodialysis treatment area on 01/19/2024 at 8:55 AM, revealed the arterial drip chamber fluid levels were < 85% full and the venous drip chamber fluid levels were > 75% full in Stations 2, 3, 7, 14, 15, and 18. Observation of the hemodialysis treatment area on 01/19/2024 at 9:35 AM with the Clinical Manager (CM), revealed the arterial drip chamber fluid levels were < 85% full in Stations 2, 3, 4, 5, 7, 8, 14, 15, 16, 18, and 19, and the venous drip chamber fluid levels were > 75% full in Stations 2, 3, 5, 7, 14, 15, 16, and 18. During an interview on 01/19/2024 at 9:35 AM in the treatment area, the Clinical Manager acknowledged the arterial and venous drip chamber fluid levels were not maintained according to the manufacturer’s DFU. During an interview on 01/19/2024 at 9:45 AM, Registered Nurse (RN) #3 stated the chamber levels should be maintained three quarters full during dialysis treatments. RN #3 did not recall what levels were taught during training. Review of a facility procedure titled, “Initiation of Treatment Using an Arteriovenous Graft or Fistula and Optiflux Single Use Ebeam Dialyzer,” dated 07/06/2021, revealed that a “Final Machine Verification” section included, “Prior to starting the blood pump, verify the following: 1. All connections are secure. 2. Dialysate lines are attached properly to the dialyzer. 3. There is at least 300 ml [milliliters] of saline in the saline bag and the saline line is double clamped. 4. Any unused administration lines are clamped. 5. The arterial chamber is 85-95% full, and venous chamber is 65-75% full. 6. Arterial and venous monitoring transducers are securely connected, not wet with saline, and the transducer clamps are open. 7. Blood pump segment is threaded through the pump properly. 8. Venous drip chamber is correctly positioned in its housing and venous bloodline is threaded through venous occluding clamp. 9. No kinks or bends are evident in any of the tubing. 10. No air is noted in the dialyzer or bloodlines.” Review of a manufacturer’s DFU titled “Hemodialysis Blood Tubing Set with Priming Set and Transducer Protectors” revealed, “2. During Treatment” section that staff should “a. Periodically check the extracorporeal circuit for any evidence of possible Separation [sic] or leaks. b. Maintain fluid level in pre-pump arterial chamber at 85 to 95% full, post-pump arterial and venous chambers at 65 to 75% full. Levels may rise or drop during the treatment due to changes in pressure or flow rate. Readjust levels as needed. Air Leaks [sic] will also cause the chamber levels to fluctuate.” 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: 35949 Based on record review, interview, and facility policy review, it was determined that the facility failed to ensure staff documented the monitoring of patients during dialysis treatments according to policy for 2 (Patient #2 and Patient #3) of 4 sampled in-center patients. Findings include: 1. Review of Patient #2’s electronic “Treatment Sheet for Facility: [Name of facility]” from 01/01/2024 through 01/17/2024, revealed the following: - 01/10/2024 - There was no blood flow rate (BFR) or dialysate flow rate (DFR) documented between 9:39 AM and 11:01 AM (a duration of 82 minutes); and - 01/17/2024 - There was no BFR or DFR documented between 12:02 PM and 1:45 PM (a duration of 103 minutes). During an interview on 01/19/2024 at 12:49 PM, Registered Nurse (RN) #3 stated she was trained to document every 30 minutes during a patient’s dialysis treatment. During an interview on 01/19/2024 at 1:10 PM, Patient Care Technician (PCT) #9 stated she was trained to document every 30 minutes during a patient’s dialysis treatment. During an interview on 01/18/2024 at 2:25 PM, the Clinical Manager (CM) confirmed the patient’s treatment sheets lacked the required documented monitoring every 30 to 45 minutes per the facility policy. The CM stated staff were trained to document according to the facility’s policy. 2. Review of Patient #3’s electronic “Treatment Sheet for Facility: [Name of facility]” from 01/01/2024 through 01/17/2024 revealed that, on 01/06/2024, there was no blood pressure, blood flow rate (BFR), or dialysate flow rate (DFR) documented between 9:59 AM and 11:02 AM (duration of 63 minutes). During an interview on 01/19/2024 at 12:49 PM, Registered Nurse (RN) #3 stated she was trained to document every 30 minutes during a patient’s dialysis treatment. During an interview on 01/19/2024 at 1:10 PM, Patient Care Technician (PCT) #9 stated she was trained to document every 30 minutes during a patient’s dialysis treatment. During an interview on 01/18/2024 at 2:25 PM, the Clinical Manager (CM) confirmed the patient’s treatment sheet lacked the required documented monitoring every 30 to 45 minutes per the facility policy. The CM stated staff were trained to document according to the facility’s policy. Review of a facility policy titled, “Patient Monitoring and Safety Checks During Hemodialysis Treatment,” dated 09/05/2023, revealed “Monitor and document every 30 minutes or more frequently as needed but not to exceed 45 minutes or per state regulations in [Name of facility] Treatment Record.” N.J.A.C. 8:43A-24.4(a)”

“POC-ACHIEVE ADEQUATE CLEARANCE CFR(s): 494.90(a)(1) Achieve and sustain the prescribed dose of dialysis to meet a hemodialysis Kt/V of at least 1.2 and a peritoneal dialysis weekly Kt/V of at least 1.7 or meet an alternative equivalent professionally-accepted clinical practice standard for adequacy of dialysis. This Standard is not met as evidenced by: 35949 Based on record review, interview, and policy review, it was determined that the facility failed to follow individualized dialysis prescriptions as determined by a medical provider for 4 (Patients #1, #2, #3, and #4) of 7 sampled patients. Findings include: 1. Review of Patient #1’s “Patient Transfer” report revealed a prescribed blood flow rate (BFR) of 400 milliliters per minute (mL/min). Review of Patient #1’s electronic “Treatment Sheet for Facility: [Name of facility]” records from 01/01/2024 through 01/17/2024 indicated the following: - 01/04/2024 - The BFR was documented at 450 mL/min from 10:32 AM until 11:00 AM; - 01/06/2024 - The BFR was documented at 300 mL/min from 12:00 PM until 1:34 PM; - 01/13/2024 - The BFR was documented at 450 mL/min from 10:40 AM until 12:06 PM; and - 01/16/2024 - The BFR was documented at 450 mL/min from 11:02 AM until 12:32 PM. The record did not reveal a documented objective rationale for the change to the prescribed BFR. 2. Review of Patient #2’s “Patient Transfer” report and “Current Orders Report” revealed a prescribed blood flow rate (BFR) of 600 milliliters per minute (mL/min) and a prescribed dialysate flow rate (DFR) of 800 mL/min. Review of Patient #2’s electronic “Treatment Sheet for Facility: [Name of facility]” records from 01/01/2024 through 01/17/2024 indicated the following: - 01/05/2024 - The BFR was documented at 300 mL/min and the DFR was documented at 500 mL/min from 9:29 AM until 10:31 AM, and the BFR was documented at 350 mL/min and the DFR was documented at 600 mL/min from 10:31 AM until 12:02 PM; and - 01/10/2024 - The BFR was documented at 500 mL/min from 1:01 PM until the treatment was terminated at 2:00 PM. The record did not reveal a documented objective rationale for the change to the prescribed BFR or DFR. 3. Review of Patient #3’s “Patient Transfer” revealed a revealed a prescribed blood flow rate (BFR) of 450 milliliters per minute (mL/min). A review of Patient #3’s electronic “Treatment Sheet for Facility: [Name of facility]” records from 01/01/2024 through 01/17/2024 revealed the following: - 01/04/2024 - The BFR was documented at 400 mL/min from 10:31 AM until the treatment was terminated at 1:39 PM; - 01/09/2024 - The BFR was documented at 400 mL/min from 11:31 AM until the treatment was terminated at 1:24 PM; and - 01/13/2024 - The BFR was documented at 500 mL/min during the entire treatment, from 9:52 AM until 1:10 PM. The record did not reveal a documented objective rationale for the change to the prescribed BFR. 4. Review of Patient #4’s “Patient Transfer” report revealed a prescribed blood flow rate (BFR) of 450 milliliters per minute (mL/min). Review of Patient #4’s electronic “Treatment Sheet for Facility: [Name of facility]” from 01/01/2024 through 01/17/2024 indicated the following: - 01/04/2024 - The BFR was documented at 455 mL/min from 4:54 AM until 5:43 AM, and 400 mL/min from 5:43 AM until 6:32 AM; - 01/11/2024 - The BFR was documented at 400 mL/min from 6:00 AM until 9:05 AM; - 01/13/2024 - The BFR was documented at 400 mL/min from 6:30 AM until the treatment was terminated at 8:30 AM; and - 01/16/2024 - The BFR was documented at 425 mL/min from 5:31 AM until the treatment was terminated at 8:48 AM. The record did not reveal a documented objective rationale for the change to the prescribed BFR. During an interview on 01/19/2024 at 12:49 PM, Registered Nurse (RN) #3 stated staff were trained to document a rationale for changes to a patient’s prescribed BFR and dialysis flow rate (DFR). During an interview on 01/18/2024 at 2:25 PM, the Clinical Manager (CM) confirmed the treatment sheets lacked documentation regarding why changes occurred to the patient’s prescribed BFR. The CM stated staff were trained to document rationales when the BFR was not achieved. During an interview on 01/19/2024 at 12:35 PM, the Medical Director stated staff were expected to include rationales for changes to a patient’s prescribed BFR and DFR. Review of a facility policy titled, “Physician Order Documentation,” dated 07/03/2023, revealed “Nurse practice acts require nurses to carry out treatment care, medication administration, lab tests, procedures, and other treatments, based on physician orders.” N.J.A.C. 8:43A-24.4(a)”