Fmc Colonia

“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, staff interview, and review of facility documents, it was determined that the facility failed to ensure that all necessary supplies are available in two of two emergency evacuation boxes and that no expired items are available for use in the evacuation box. Findings include: On 1/13/25 at 11:25 AM, two emergency evacuation boxes (Box 1 and Box 2) for the In-center Hemodialysis Unit were opened and contained a the list of contents titled, “Emergency Mobile Kit Checklist.” Staff (S) 2, the Charge Nurse, also provided the electronic evacuation box checklist for Box 1 and Box 2 which indicated the boxes were last checked for contents and expired items on 12/10/24. A review of the contents with the lists revealed the following: A sharps container was documented as present on the electronic list but was not present in either of the two evacuation boxes. Box 1 contained five intravenous (IV) priming kits which expired on 11/24. A document that stated, “Staff Phone Numbers” with a date of “4/19/10” printed at the top was present in the evacuation box but did not contain contact information for all of the current staff. The patient’s emergency contact information present in the box was last printed on 5/23/24. During an interview at 11:52 AM, S2 confirmed there was no sharps container in either evacuation box and the IV priming kits were expired. S2 removed the expired kits, disposed of them, and replaced them with unexpired IV priming kits. S2 stated the patient emergency contacts is supposed to be updated quarterly. The patient information present in the evacuation box did not reflect that it was updated quarterly. S2 printed current patient demographic information inclusive of emergency contacts and placed it into the evacuation box. S2 also confirmed the “Staff Phone Numbers” list that was present in the box was not an updated version and there was no updated version available inside of the evacuation box. S2 stated that there is an updated staff contact list in a drawer at the nurse’s station. Facility policy titled, “Emergency Medications, Equipment, and Supplies,” revised on published 05/01/23 stated, “... Emergency Evacuation Box: An emergency evacuation box contains supplies primarily needed to emergently remove needles ... Emergency Evacuation Box: An emergency evacuations box must: ... Contain all patient and staff emergency contact information. ... An itemized log must be kept indicating the contents and expiration dates of contents. Items approaching expiration must be reordered and replaced prior to the actual expiration date. ...” N.J.A.C 8:43A-15.1(a)”

“IC-WEAR GLOVES/HAND HYGIENE CFR(s): 494.30(a)(1) Wear disposable gloves when caring for the patient or touching the patient’s equipment at the dialysis station. Staff must remove gloves and wash hands between each patient or station. This Standard is not met as evidenced by: 37656 Based on one of two observations of hand hygiene, staff interview, and a review of facility documents, it was determined that the facility failed to ensure that staff performs hand hygiene to prevent cross contamination in accordance with the facility policy. Findings include: On 1/13/25 at 10:10 AM, Staff (S) 5, a Registered Nurse, was observed retrieving gloves from a clean cart located next to the medication cart in Pod B on the treatment floor. S5 donned (put on) the gloves without the benefit of hand hygiene and then entered Station 5 and touched the dialysis machine. After touching the machine, S5 removed his/her gloves then exited the station, did not perform hand hygiene, and went to the medication preparation area on the medication cart in Pod B. S5, without first performing hand hygiene removed a Heparin (an intravenous (IV) medication) vial from a drawer in the cart, wiped the top of the heparin vial with an alcohol swab and withdrew two doses of Heparin into two syringes. In an interview at 10:15 AM, S5 stated that he/she performed hand hygiene earlier when he/she prepared medication for another patient, but did not perform hand hygiene this time. Facility policy titled, “Hand Hygiene,” published 11/06/2023, stated, “... Hands will be decontaminated using alcohol-based hand rub or washing hands with antimicrobial soap and water, When ... entering and leaving the treatment area ... Immediately after removing gloves. ...” Facility policy titled, “Medication Preparation and Administration,” published 02/06/2023, stated, “... Infection Control ... The following steps must be taken to ensure infection control: Perform hand hygiene prior to accessing supplies, handling vials ... and preparing ... medications. Aseptic technique will be used to prepare ... IV medications. ...” N.J.A.C 8:43A-24.8(b)”

“IC-STAFF EDUCATION-CATHETERS/CATHETER CARE CFR(s): 494.30(a)(2) Recommendations for Placement of Intravascular Catheters in Adults and Children I. Health care worker education and training A. Educate health-care workers regarding the ... appropriate infection control measures to prevent intravascular catheter-related infections. B. Assess knowledge of and adherence to guidelines periodically for all persons who manage intravascular catheters. II. Surveillance A. Monitor the catheter sites visually of individual patients. If patients have tenderness at the insertion site, fever without obvious source, or other manifestations suggesting local or BSI [blood stream infection], the dressing should be removed to allow thorough examination of the site. Central Venous Catheters, Including PICCs, Hemodialysis, and Pulmonary Artery Catheters in Adult and Pediatric Patients. VI. Catheter and catheter-site care B. Antibiotic lock solutions: Do not routinely use antibiotic lock solutions to prevent CRBSI [catheter related blood stream infections]. This Standard is not met as evidenced by: 49828 Based on observation, staff interviews, and a review of facility policies, it was determined that the facility failed to ensure that infection control practices for cleaning the central venous catheter (CVC, a type of access used for hemodialysis) exit site and limbs prior to initiating hemodialysis using a CVC in two of two observations is implemented. Findings include: On 1/13/25 at 9:25 AM in Station 1, Staff (S) 5, a Registered Nurse (RN), was observed initiating hemodialysis through a CVC located on Patient (P) 11’s right chest wall. S5 placed a blue pad under the catheter limbs then removed the dressing exposing P11’s exit site. S5 then used one chlorhexidine (antiseptic and disinfectant) swab and used gentle friction in circular motions starting at the insertion site and moving outward, then back to the insertion site with the same swab, repeating the action four times with the same swab for 25 seconds. This was five seconds less than required by facility policy. Moving from the dirty area of the exit site back to the cleaned area with the same swab causes potential for cross contamination. Following the dressing change, S5 removed the red (arterial) end cap of the catheter limb and with an alcohol pad, cleaned the end of the hub and the threads for 15 seconds. S5 then attached a 10 ml (milliliter) syringe, aspirated five ml of blood, attached a prefilled normal saline syringe and flushed the limb. S5 did not clean from the hub at least several centimeters toward the body of the catheter. S5 then removed the blue (venous) end cap of the catheter limb and then with a new alcohol pad, cleaned the end of the hub and the threads for 10 seconds. S5 then attached a 10 ml syringe, aspirated five ml of blood, attached a prefilled normal saline syringe and flushed the limb. S5 did not clean from the hub at least several centimeters toward the body of the catheter in accordance with facility policy. During an interview at 10:00 AM, S5 stated that the facility policy requires scrubbing the threads for 15 seconds with the alcohol pad. S5 confirmed he/she did not move up the catheter limb and stated he/she is not required to move up the catheter limb while cleaning the threads or clean any part of the catheter limb during the initiation of a CVC. At 10:35 AM in Station 5, S5 was observed initiating hemodialysis through a CVC located on P3’s right chest wall. S5 placed a blue pad under the catheter limbs then removed the dressing exposing P11’s exit site. S5 then used one chlorhexidine swab and used gentle friction in circular motions starting at the insertion site and moving outward, then back to the insertion site with the same swab, repeating the action four times with the same swab for 20 seconds. This was 10 seconds less than required by facility policy. Moving from the dirty area of the exit site back to the cleaned area with the same swab causes potential for cross contamination. Following the dressing change, S5 removed the red (arterial) end cap of the catheter limb and with an alcohol pad, cleaned the end of the hub and the threads for seven seconds (this was three seconds less than required by facility policy). S5 then attached a 10 ml syringe, aspirated five ml of blood, and attached a prefilled normal saline syringe to flush the limb. S5 did not clean from the hub at least several centimeters toward the body of the catheter. S5 then removed the blue (venous) end cap of the catheter limb and with a new alcohol pad, cleaned the hub and threads for 13 seconds. S5 then attached an empty 10 ml syringe, aspirated five ml of blood, and attached a prefilled normal saline syringe to flush the limb. S5 did not clean from the hub at least several centimeters toward the body of the catheter in accordance with facility policy. The personnel file of S5 was reviewed and indicated an annual skills assessment for in-center RNs was completed on 12/31/2024, which included: initiation of dialysis through a CVC, CVC exit site care, and “Scrub the hub.” Facility policy titled, “Changing the Catheter Dressing Procedure,” revised 02/05/24, stated, “... Cleaning the Site Follow the steps below to clean the catheter site: ... Step 2 ... 2% Chlorhexidine and 70% alcohol: Using gentle back and forth friction, clean the exit site beginning in the center and continuing outward the area of the size of the dressing to be applied [2 inches] in a concentric circle for 30 seconds and allow to dry a minimum of 30 seconds. ...” Facility policy titled, “Initiation of Treatment Using a Central Venous Catheter [CVC] and Optiflux Single Use Ebeam Dialyzer,” published 05/06/24 stated, “Preparing the Catheter: Disinfection of the Catheter Connections, ... Step 3. Using a sterile alcohol pad ... scrub the sides (threads) and end of the hub thoroughly with friction, making sure to remove any residue ... Step 4. Using the same sterile alcohol pad ... applying friction to remove any blood or residue, move from the hub at least several centimeters toward the body of the catheter. [Steps 3 and 4 should take 10-15 seconds.] ...” N.J.A.C. 8:43A-24.8(b)”

“PE-BUILDING-CONSTRUCT/MAINTAIN FOR SAFETY CFR(s): 494.60(a) The building in which dialysis services are furnished must be constructed and maintained to ensure the safety of the patients, the staff and the public. This Standard is not met as evidenced by: 51040 Based on observation and staff interview, it was determined that the facility failed to ensure the dialysis facility is maintained to ensure safety of the patients, the staff and the public. Findings include: Reference: NFPA (National Fire Protection Association) 101, 2012 Edition, “18.7.8 Portable Space-Heating Devices. Portable space-heating devices shall be prohibited in all health care occupancies.” On 1/14/25 at 11:30 AM, during a tour of the facility with Staff (S) 7, the Bio-Medical Technician, the following was observed: Three portable electric space heaters were observed to be in use in the Patient Waiting Room. There was a missing electrical outlet cover on the patient floor area to the left of the filing cabinet behind the nurse’s station. The cabinet laminate was coming apart near Station 7 at the level just above the floor surface, which can not be properly cleaned and maintained. On 1/14/25 at 11:50 AM, S7 confirmed the above findings. N.J.A.C. 8:43A-17.3(j)”

“PR-PRIVACY & CONFIDENTIALITY-TREATMENT CFR(s): 494.70(a)(3) The patient has the right to- (3) Privacy and confidentiality in all aspects of treatment; This Standard is not met as evidenced by: 49828 Based on four of four observations of the initiation and termination of hemodialysis through a Central Venous Catheter (CVC, a type of access used for hemodialysis) for Patient (P) 1, P3, and P11, staff interview, and review of facility policy, it was determined that the facility failed to ensure the privacy of each patient. Findings include: On 1/13/25 at 9:25 AM in Station 1, the initiation of hemodialysis through a CVC located on P11’s right chest wall was observed. P11 was wearing a T-shirt which was fully opened in the middle during the procedure exposing his/her chest. The curtains were fully extended on the right and left sides of the station, however, the curtain was not fully extended in the front of the station leaving a two-foot opening. This opening allowed for P11’s exposed chest to be visible to other staff members who were observed walking past the station during the procedure. At 10:15 AM, in Station 4, the termination of hemodialysis through a CVC located on P1’s left chest wall was observed. Staff (S) 5, a Registered Nurse, fully extended the privacy curtain located on the right side of the station to ensure P1’s privacy. S5 then drew the curtain on the left side a little more than halfway, leaving a four foot opening, which allowed for P1’s exposed chest to be visible. S5 also did not draw the privacy curtain located in the back of the station. This allowed for staff members and patients in Stations 5, 10, and 11 on the treatment floor to have a view of P1’s care. At 10:35 AM in Station 5, the initiation of hemodialysis through a CVC located on P3’s right chest wall was observed. The curtains were fully extended on the right and left sides, and the front of the station, however, the curtain in the back of the station remained open during the procedure which allowed for the patient to be visible to other staff members not involved in the care of P3, that were observed walking past the station during the procedure. At 1:45 PM in Station 5, the termination of hemodialysis through a CVC was observed for P3. The curtains were fully extended on the right and left sides, and the front of the station, however, the curtain in the back of the station remained open during the procedure which allowed the patient to be visible to other staff members not involved in the care of P3, that were observed walking past the station during the procedure. During an interview at 10:38 AM, S5 stated, “I only close the curtain as needed. I need to see the clock hanging on the wall on the other side of the station too, so I did not close the curtains on the half back wall.” At 11:45 AM, an interview was conducted with S3, the Charge Nurse, who confirmed that all the privacy curtains located in the station should be fully closed during initiation and termination of hemodialysis treatments and CVC care. Facility policy titled, “Patient Rights and Responsibilities,” published 04/04/2012, stated, “... Policy: Privacy Rights ... Patients have the right to privacy during activities that may require the exposure of private body parts while in the dialysis facility. Privacy screens or curtains may be used to provide privacy. ...” N.J.A.C. 8:43A-16.2(a)10”

“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: 37656 Based on one of seven medical records reviewed (Patient (P) 4), staff interviews, and review of facility documents, it was determined that the facility failed to ensure that post hemodialysis nursing assessments are completed according to facility policy. Findings include: A review of the annual Plan of Care dated, 10/30/24, stated, “... Area of Focus ... BP [blood pressure] and Fluid Management ... Achieve BP control as specified by the patient’s physician ... Intervention ... Educate patient/family/caregiver on fluid control ...” A review of P4’s Treatment Flow Sheets revealed the following: Treatment Flow Sheet dated, 12/25/24, the pre-treatment assessment stated, “... Physical Exam ... Ankle - Severity ... 1+: 2 mm (millimeter) or less, disappears rapidly ... Lower leg - Severity ... 1+: 2 mm (millimeter) or less, disappears rapidly ... Pulse rhythm ... Irregular ...” The post treatment assessment stated, “... General Assessment -Cardiovascular ... No associated Symptoms ... Physical Exam ... No unusual finding...” The post treatment assessment did not contain a re-assessment of the ankle and lower leg edema and the irregular pulse. Treatment Flow Sheet dated, 01/03/25, the pre-treatment assessment stated, “... Fluid Assessment ... Lungs ...Decrease breath sounds ... Ankle - Severity ... 2+: 2-4 mm (millimeter) indent, disappears in 10-15 seconds ... Lower leg - Severity ... 2+: 2-4 mm (millimeter) indent, disappears in 10-15 seconds ... Pulse rhythm ... Irregular ...” The post treatment assessment stated, “... Nursing Evaluation ... No unusual findings noted ...” The post treatment assessment did not contain a re-assessment of the ankle and lower leg edema, the irregular pulse, and did not document a re-assessment of the lungs. Treatment Flow Sheet dated, 01/06/25, the pre-treatment assessment stated, “... Fluid Assessment ... Lungs ...Decrease breath sounds ... Ankle - Severity ... 2+: 2-4 mm (millimeter) indent, disappears in 10-15 seconds ... Lower leg - Severity ... 2+: 2-4 mm (millimeter) indent, disappears in 10-15 seconds ...” The post treatment assessment stated, “... Nursing Evaluation ... No unusual findings noted ...” The post treatment assessment did not contain a re-assessment of the ankle and lower leg edema and did not document a re-assessment of the lungs. Treatment Flow Sheet dated, 01/08/25, the pre-treatment assessment stated, “... Fluid Assessment ... Lungs ...Decrease breath sounds ... Ankle - Severity ... 2+: 2-4 mm (millimeter) indent, disappears in 10-15 seconds ... Lower leg - Severity ... 2+: 2-4 mm (millimeter) indent, disappears in 10-15 seconds ... “ The post treatment assessment stated, “... Nursing Evaluation ... No unusual findings noted ...” The post treatment assessment did not contain a re-assessment of the ankle and lower leg edema and did not document a re-assessment of the lungs. Treatment Flow Sheet dated, 01/10/25, the pre-treatment assessment stated, “... Fluid Assessment ... Lungs ...Decrease breath sounds ... Ankle - Severity ... 1+: 2 mm (millimeter) indent, disappears rapidly ... Lower leg - Severity ... 1+: 2 mm (millimeter) indent, disappears rapidly ...” The post treatment assessment stated, “... Nursing Evaluation ... No unusual findings noted ...” The post treatment assessment did not contain a re-assessment of the ankle and lower leg edema and did not document a re-assessment of the lungs. On 1/15/25 at 9:25 AM, the Treatment Flow Sheets were reviewed with Staff (S) 1, the Clinical Manager. S1 confirmed that the staff were not doing a proper post treatment assessment of the patient post dialysis. Facility policy titled, “Patient Assessment and Monitoring,” published 5/1/2023, stated, “... Post Treatment ... Follow the steps below for obtaining post-treatment assessment data: ... Pulse ... Ensure vital signs and overall condition are stable for discharge ... Lung sounds ... Edema ...The registered nurse will assess/re-assess post treatment as indicated. Document findings in the patient’s record. ...” N.J.A.C. 8:43A-24.4(a)”

“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: 50912 Based on one of three observations of the initiation of hemodialysis through an arteriovenous graft/fistula (AVG/F, a type of vascular access used for hemodialysis), staff interview, and a review of facility documents, it was determined that the facility failed to ensure that staff perform skin disinfection of the access site prior to initiating the dialysis treatment in accordance with facility policy. Findings include: On 1/13/25 at 11:20 AM in Station 15, Staff (S) 4, a Patient Care Technician (PCT), initiated dialysis through Patient (P) 10’s right upper arm AVG. S4 cleansed the first site of the AVG with a 70% isopropyl alcohol pad in a circular motion for 12 seconds then cannulated (the act of inserting a needle into the vascular access). This is 18 seconds less than required by facility policy. S4 then cleansed the second site of the AVG with an alcohol pad in a circular motion for 20 seconds then cannulated. This is 10 seconds less than required by facility policy. During an interview at 11:27 AM, S4 stated he/she should clean each site of the access for at least 30 seconds with alcohol. Facility policy titled, “Access Assessment and Cannulation,” published 5/06/2024 stated, “ ... Skin Disinfection Step 1. Disinfect cannulation site as follows using any of these disinfectants ... 70 % isopropyl alcohol pad: using gentle friction, clean the access site beginning in the center and continuing ... for 30 seconds and allow to dry before cannulating. ...” N.J.A.C. 8:43A-24.8(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: 51990 Based on one of seven medical records reviewed (Patient (P) 3), staff interviews, and review of facility documents, it was determined that the facility failed to ensure that the physician sees patients in person while receiving in-center hemodialysis (ICHD) at least quarterly. Findings include: On 1/14/25, a review of P3’s medical record for the months of July, August, September, October, November, and December 2024, revealed that the physician had seen the patient via telehealth visits monthly. The “Provider Rounding Note Basic HD” document for the above months stated, “Method of Interaction: Via Telephone.” During an interview at 11:50 AM, Staff (S) 1, the Clinical Manager stated that the physician for P3 sees them via telehealth monthly and confirmed the medical record lacked documented evidence that P3 was seen in the facility while receiving hemodialysis in the above months reviewed. On 1/15/25, during an interview at 12:50 PM, S13, the Medical Director, indicated that a face- to-face visit should have occurred and that he/she planned on re-educating all of the physicians. Facility policy titled, “Comprehensive Interdisciplinary Assessment and Plan of Care,” published 07/03/2023 stated, “... Frequency of Patient Visits by the Physician or Physician Extender ... The dialysis facility must ensure that all in center patients are seen by a medical practitioner (i.e. physician, advance practice registered nurse, or physician’s assistant) providing ESRD care at least monthly ... At least quarterly, one medical practitioner visit must be in the dialysis facility while the hemodialysis patient is receiving in facility dialysis ...” N.J.A.C. 8:43A-24.4(a)”

“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 review of facility documents, it was determined the medical director failed to ensure that: 1) multidose medications are prepared in accordance with the facility policy in one of one observation; and 2) electrically powered items brought into the facility by a patient are not utilized by the patient on the clinic floor in one of one observation. Findings include: 1. On 1/13/24 at 9:24 AM, Staff (S) 5, a Registered Nurse, was observed in the medication preparation area. S5 acquired a multidose vial of Heparin (intravenous medication), swiped the top of the vial briskly once with an alcohol pad, and then immediately accessed the vial with a needle attached to a syringe. S5 then withdrew the medication from the vial for administration. S5 did not use friction when cleaning the diaphragm of the vial and did not allow it dry before inserting the needle. Facility policy titled, “Medication Preparation and Administration,” published 02/06/23 stated, “... Infection Control The following steps must be taken to ensure infection control. ... Cleanse the diaphragm of the 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% alcohol. Allow to dry before inserting a device into the vial. ...” 2. On 1/13/24 at 10:44 AM in Station 5, following the initiation of dialysis, S5 reached into Patient (P) 3’s personal belonging bag, removed an electrically powered heated blanket and placed the blanket over top of P3’s arms and legs while the patient was seated in the dialysis chair. S5 then plugged the power cord of the heated blanket into the electrical outlet located in the station behind the treatment chair. During an interview at 10:56 AM, S3, the Charge Nurse, stated patients have been complaining that they were cold, so the facility has been allowing them to bring heated blankets for use during treatment. A request for a policy was made at this time. At 1:51 PM in Station 5, three hours and seven minutes after the heated blanket was plugged in, the patient’s dialysis treatment was terminated. S5 was then observed unplugging the blanket from the outlet, placing the blanket back into the patients personal belonging bag and the patient was discharged from the facility. Facility policy titled, “Electrically Powered Equipment Usage,” published 11/06/23 stated, “... Policy: No electrically powered items can be brought into the clinic by a patient and used on the clinical floor. ...” N.J.A.C. 8:43A-24.4(a)”