Trinitas Medical Arts Building - Dialysis

“IC-SANITARY ENVIRONMENT CFR(s): 494.30 The dialysis facility must provide and monitor a sanitary environment to minimize the transmission of infectious agents within and between the unit and any adjacent hospital or other public areas. This Standard is not met as evidenced by: 48966 Based on one of two observation of cleaning the dialysis station, staff interviews, and review of facility policy, it was determined that the facility failed to provide and maintain a sanitary environment to minimize the transmission of infectious agents within and between the hemodialysis station. Findings include: On 7/24/24 at 10:23 AM, Staff (S) 7, a Registered Nurse, was observed cleaning hemodialysis Station #2. The red sharps container and red medical waste container were touching the privacy curtain between Station #1 and Station #2. The privacy curtain had a reddish brown stained area approximately 3 inches in diameter. During an interview at 10:35 AM, S4, the Hospital Nurse Manager, confirmed the privacy curtain between Station #1 and #2 had a visible stained area present. During an interview at 10:56 AM, S8, the Nurse Manager, stated the Nurse Manager and Charge Nurse do weekly environmental rounds. If something is observed that needs attention housekeeping is called to address the issue. Housekeeping is responsible for changing the soiled curtains. A review of the facility policy titled, “Infection Control for Dialysis Facilities,” reviewed in 2/23, stated, “... Staff/Patient Safety 18. All procedures involving blood or other body fluids will be performed in a manner to minimize splashing, spraying, spattering or generation of droplets ...” N.J.A.C. 8:43A-24.8(d)”

“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: 48966 Based on one of two observations of the pHoenix Meter XL (hand-held meter for measuring conductivity, temperature, and pH of solutions) calibration stations, staff interviews, and review of manufacturers direction for use, it was determined the facility failed to ensure the Reverse Osmosis (RO) water and bleach solution bottle are properly labeled. Findings include: During an observation on 7/22/24 at 12:14 PM, the pHoenix meter calibration station at Clean Sink #2, across from Station #6, lacked a dated, initialed, and timed label on the RO water and bleach solution bottles. The manufacturer’s instructions on the RO water bottle specified “to empty this bottle daily and refill it with fresh RO water. Wash with a disinfectant soap or diluted soap.” The manufacturer’s instructions on the bleach solution bottle specified “mix one part household bleach and 99 parts RO water, empty, rinse, and refill this container daily.” During an interview at 12:16 PM, Staff (S) 6, the Charge Nurse, confirmed the bottles were not labeled and was uncertain when the bottles contents were last changed. During an interview at 12:23 PM, S5, a Patient Care Technician (PCT), confirmed the RO and bleach bottles should be labeled. S5 stated the PCT in the morning is responsible to change the RO water and bleach daily and label the bottles with the date, time, and initials. S5 was unsure when the bottles were last changed. During an interview on 7/24/24 at 10:27 AM, S9, the Biomed Technician, confirmed the RO and bleach bottles should be labeled with the date, time, and initials and the contents changed daily. S9 stated the PCT who opens in the morning is responsible to change the contents and label the bottles. A review of the manufacturer’s instructions for use of the pHoenix Meter XL stated, “... It is recommended that treated water (RO, DI, or Distilled water) be the only choice for rinsing meters. Disinfecting Recommendations - Measurement Module and Syringe. If disinfection of the meter is required (other than those meters in storage), we recommend that you follow these steps daily before the first use of the meter: 1. Draw 1% bleach solution (one-part bleach to ninety-nine parts dialysis quality water) mixed fresh daily, into the meter to the 10 mL [milliliter] line. Seal the Measurement Module with an Air-Tight Luer Cap. 2. Let the solution sit in the meter for approximately ten minutes. After the dwell time expel the bleach solution. 3. Rinse thoroughly by rapidly flushing at least three times with dialysis quality water ...””

“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: 48966 Based on staff interview, medical record reviews, and review of policies and procedures, it was determined that the facility failed to ensure that hemodialysis treatments were provided in accordance with the hemodialysis prescription for seven of seven patient medical records reviewed (Patient (P) 1, 2, 3, 4, 5, 6 and 7). Findings include: A review of P1’s medical record revealed the following: An initial patient plan of care, dated and signed by the patient and the interdisciplinary care team on 4/24/24, indicated there were no concerns with P1 meeting their adequacy goal. The hemodialysis orders dated 7/1, 7/8, 7/10, 7/12, 7/15, 7/17, and 7/19/24, stated, “... Dialysis Flow Rate (DFR): 800 ...” The “Hemodialysis Record” for the corresponding order dates lacked evidence of the DFR utilized throughout the treatment. A review of P3’s medical record revealed the following: A patient plan of care, dated and signed by the patient and the interdisciplinary care team on 2/27/24, indicated there were no concerns with P3 meeting their adequacy goal. The hemodialysis orders dated 7/2, 7/4, 7/6, 7/11, 7/13, 7/16, 7/18, an 7/20/24, stated “...Dialysis Flow Rate (DFR): 800 ...” The “Hemodialysis Record” for the corresponding order dates lacked evidence of the DFR utilized throughout the treatment. 49828 A review of P2’s medical record revealed the following: A patient plan of care, dated and signed by the patient and the interdisciplinary care team on 2/15/24, indicated there were no concerns with P2 meeting their adequacy goal. The hemodialysis orders dated 7/2, 7/9, and 7/16/24, stated, “ ...DFR: 800 ...” The “Hemodialysis Record” for the corresponding dates lacked evidence of the DFR utilized throughout the treatment. A review of P4’s medical record revealed the following: A patient plan of care, dated and signed by the patient and the interdisciplinary care team on 2/21/24, indicated there were no concerns with P4 meeting their adequacy goal. The hemodialysis orders dated 7/1, 7/3, 7/5, 7/8, 7/10, 7/12, 7/15, 7/17, and 7/19/24, stated, “ ...DFR: 800 ...” The “Hemodialysis Record” for the corresponding dates lacked evidence of the DFR utilized throughout the treatment. A review of P5’s medical record revealed the following: A patient plan of care, dated and signed by the patient and the interdisciplinary care team on 2/28/24, indicated there were no concerns with P5 meeting their adequacy goal. The hemodialysis orders dated 7/1, 7/3, 7/5, and 7/8/24, stated, “ ...Dialysis Flow Rate (DFR): 800 ...” The “Hemodialysis Record” for the corresponding dates lacked evidence of the DFR utilized throughout the treatment. 37656 A review of P6’s medical record revealed the following: A patient plan of care, dated and signed by the patient and the interdisciplinary care team on 2/27/24, indicated there were no concerns with P6 meeting their adequacy goal. The hemodialysis orders, dated 7/1, 7/3, 7/5, 7/8, 7/10, 7/12, 7/15, 7/17, and 7/19/24, stated, “...Dialysis Flow Rate (DFR): 800 ...” The “Hemodialysis Record” for the corresponding dates lacked evidence of the DFR utilized throughout the treatment. A review of P7’s medical record revealed the following: An initial patient plan of care, dated and signed by the patient and the interdisciplinary care team on 2/19/24, indicated there were no concerns with P7 meeting their adequacy goal. The hemodialysis orders, dated 7/1, 7/3, 7/5, 7/8, 7/10, 7/12, 7/15, and 7/17/24, stated, “... Dialysis Flow Rate (DFR): 800 ...” The “Hemodialysis Record” for the corresponding dates lacked evidence of the DFR utilized throughout the treatment. During an interview on 7/24/24 at 1:14 PM, Staff (S) 8, the Nurse Manager, stated that all patients are prescribed a standard 800 DFR and the staff is aware of this. S8 stated the staff would put a note if there was a deviation from the prescribed 800 DFR but do not document the DFR on the hemodialysis treatment record. A review of the facility policy titled, “Assessment of Hemodialysis Patient,” reviewed in 2/23, stated, “... Monitoring of the patient during the hemodialysis treatment should include but not be limited to: ... Monitoring of dialysis machine parameters which include venous pressure, ultrafiltration rate, ultrafiltration goal, dialysis time, dialysate temperature, dialysate conductivity, blood flow, and dialysate flow rate ...” N.J.A.C. 8:43A-24.4(a)”

“MD RESP-DEVELOP, REVIEW & APPROVE P&P CFR(s): 494.150(c)(1) The medical director must- (1) Participate in the development, periodic review and approval of a “patient care policies and procedures manual” for the facility; This Standard is not met as evidenced by: 37656 Based on observation, staff interviews, and a review of facility policy and procedure, it was determined that the facility Medical Director failed to develop a policy and procedure for medication preparation and administration. Findings include: On 7/22/24 at 11:08 AM, during tour of the Treatment Floor, Staff (S) 7, a Registered Nurse, was observed attaching patient medication labels onto four syringes containing clear solutions at the nurse’s station on Side A. Upon interview at the time of observation, S7 stated that he/she prepared the four syringes containing Heparin in the medication room located on Side B but he/she forgot to print the patient labels, so he/she printed the labels at the nurse’s station and was labeling the four syringes. S7, when asked how do you know that you have the right patient and the right dose, S7 stated, “I know my patient’s Heparin dosages.” After labeling the syringes, S7 walked to Station #5 and went back to the Nurse’s Station and discarded all the syringes in the sharps container. On 7/22/24 at 1:00 PM, the policy and procedure for medication preparation and administration was requested from S1, Director of Quality. A policy for Medication Management in the Renal Unit and Medication Use Process were provided but did not include a policy and procedure for medication preparation and administration by the Registered Nurse (RN). On 7/24/24, S1, Nurse Manager confirmed there was no policy and procedure for medication preparation and administration by the RN. N.J.A.C. 8:43A-9.3(a)”