Fkc North Dover

“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: 47821 Based on observation, facility document review, policy review and staff interview, it was determined that the facility failed to maintain emergency preparedness supplies for all 60 patients at this facility. Findings include: A. The facility policy titled” Emergency Medications, Equipment and Supplies” dated 05/01/23 stated, “... An emergency evacuation box contains supplies primarily needed to emergently remove needles, cap catheters, and provide saline as needed for every licensed station once the patient is in a secure location. Refer to Emergency Evacuation Box Contents...The medications and supplies outlined in this policy must be maintained at the facility for emergency use... An itemized log must be kept indicating the contents...”. B. The facility document titled “North Dover, Emergency Box Contents” dated 01/11/23 stated, “...1 box, 2x2 Gauze Pads (100/box)...25 Each, IV [intravenous] Administration Set...4, Epinephrine (Adrenalin) 1:1000 1mg/ml vial...”. C. During an environmental tour on 2/26/24 between 8:40 AM and 1:20 PM, the following was observed when checking the emergency box/crash cart: - 20 2x2 gauze pads on cart (80 2x2 gauze pads missing). - 13 IV administration sets on cart (12 IV administration sets missing). - 2 vials of 1:1000, 1mg/ml Epinephrine (Adrenalin) on cart (2 vials of 1:1000, 1mg/ml Epinephrine vials missing). These findings were confirmed with Employee #4 on 2/26/24 at 1:12 PM.”

“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: 47821 Based on observation, policy review and staff interview, it was determined that the facility failed to maintain a sanitary environment for all 60 patients at this facility. Findings include: A. The facility policy titled “Storage of Supplies” dated 04/05/21 stated, “... Proper storage conditions are necessary to provide a safe environment and to ensure supplies are not...contaminated...”. B. During an environmental tour on 2/26/24 between 8:40 AM and 1:20 PM the following was observed: - Corrugated cardboard inside of Clean Station #1; a piece of cardboard mixed in with supplies, approximately 10 inches by 4 inches. This finding was confirmed with Employee #14 on 2/26/24 at the time of discovery.”

“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: 47821 Based on observation, policy review, and staff interview, it was determined that for 2 of 8 (Patient #s 3 and 13) patient care observations, staff failed to perform hand hygiene during patient care. Findings include: A. Facility policy titled “Access Assessment and Cannulation” dated 7/5/2022 stated, “...Perform skin antisepsis...allow to dry and them [sic] cannulate. Do not touch cannulation sites after skin disinfection...” Facility policy titled “Changing the Catheter Dressing Procedure” dated 2/5/2024 stated, “...Removal of dressing and inspection of site...3 Perform hand hygiene. 4 Don clean gloves. 5 Inspect and remove the old dressing...8 Discard dressing and remove gloves. Perform hand hygiene. Prepare dressing supplies...Cleaning the site...1 Perform hand hygiene and don clean gloves...” B. Patient #3 On 2/26/2024, between 11:00 and 11:20 AM, Employee #18 was observed assessing the arteriovenous (AV) fistula of Patient #3 by inspecting, palpating, and auscultating the site. He/she then performed hand hygiene and donned gloves, applied skin antiseptic to cannulation sites, palpated the AV fistula again, and inserted and secured the first cannulation needle. Employee #18 then inspected the AV fistula and inserted and secured the second cannulation needle. During an interview on 2/26/2024 at 11:20 AM, Employee #18 confirmed after applying skin antisepsis to Patient #3’s cannulation sites, he/she palpated the AV fistula and did not remove gloves and perform hand hygiene before inserting the cannulation needles. C. Patient #13 On 2/27/2024, between 11:20 and 11:35 AM, Employee #17 was observed performing hand hygiene, removing Patient #13’s catheter dressing, discarding dressing, cleansing the catheter site, removing gloves, performing hand, donning new gloves, and applying sterile dressing to catheter site. During an interview on 2/27/2024 at 11:25 AM, Employee #17 confirmed he/she did not remove gloves, perform hand hygiene, and don new gloves after removing Patient #13’s old catheter dressing and before cleansing Patient #13’s catheter site.”

“IC-SINKS AVAILABLE CFR(s): 494.30(a)(1)(i) A sufficient number of sinks with warm water and soap should be available to facilitate hand washing. This Standard is not met as evidenced by: 47821 Based on observation, policy review and staff interview, it was determined that the facility failed to maintain a safe environment for 60 patients at this facility. Findings include: A. The facility policy titled “Hand Hygiene” dated 11/06/23 stated, “...A sufficient number of sinks with soap and plumbed with both hot and cold water shall be available to facilitate hand washing...”. B. During an environmental tour on 2/26/24 between 8:40 AM and 1:20 PM the following was observed: - A patient was receiving treatment in the isolation room. Hand wash sink in the room was blocked by a patient wheelchair. This finding was confirmed with Employee #6 on 2/26/24 at 9:55 AM.”

“IC-IF TO STATION=DISP/DEDICATE OR DISINFECT CFR(s): 494.30(a)(1)(i) Items taken into the dialysis station should either be disposed of, dedicated for use only on a single patient, or cleaned and disinfected before being taken to a common clean area or used on another patient. -- Nondisposable items that cannot be cleaned and disinfected (e.g., adhesive tape, cloth covered blood pressure cuffs) should be dedicated for use only on a single patient. -- Unused medications (including multiple dose vials containing diluents) or supplies (syringes, alcohol swabs, etc.) taken to the patient’s station should be used only for that patient and should not be returned to a common clean area or used on other patients. This Standard is not met as evidenced by: 47821 Based on observation, policy review, and staff interview, it was determined that for 2 of 8 (Patient #s 10 and 13) in-center hemodialysis patients observed on 2/26/24 and 2/27/24, staff failed to disinfect non-disposable equipment before being removed from the dialysis station. Findings include: A. Facility policy titled “Cleaning and Disinfecting the Dialysis Station” dated 9/5/23 stated, “...After use, any non-disposable equipment and supplies brought into the dialysis station (ex. Stethoscope) must be disinfected...before being removed from the dialysis station...” B. Patient #10 The following was observed on 2/26/24 at 10:55 AM during the patient assessment performed by Employee #13: - Employee #13 entered Station #10 with a stethoscope around his/her neck - Employee #13 used stethoscope to auscultate Patient #10’s lungs - Employee #13 left dialysis Station #10 with the stethoscope in hand and placed the stethoscope on the nurse’s desk across from the medication drawers without disinfecting the stethoscope During an interview on 2/26/24 between 10:55 and 11:10 AM, Employee #13 stated staff uses their personal stethoscope during patient care and confirmed he/she did not disinfect their stethoscope before removing it from dialysis Station #10. C. Patient #13 The following was observed on 2/27/24 at 11:25 AM during the patient assessment performed by Employee #11: - Employee #11 entered dialysis Station #2 with a stethoscope in his/her hands - Employee #11 used stethoscope to auscultate Patient #13’s lungs - Employee #11 placed the stethoscope around their neck, left dialysis Station #2, and went to dialysis Station #11 and spoke with the patient without disinfecting the stethoscope During an interview on 2/27/24 at 11:35 AM, Employee #11 confirmed he/she did not disinfect their stethoscope before removing it from dialysis Station #2.”

“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: 47821 Based on observation, policy review, and staff interview, it was determined that for 1 of 2 (Patient #10) patients observed receiving intravenous (IV) medication, staff failed to adhere to aseptic technique requirements. Findings include: A. Facility policy titled “Medication Preparation and Administration” dated 2/6/2023 stated, “...The following steps must be taken to ensure infection control...Disinfect IV ports prior to accessing...Cleanse each time an IV port is accessed...” B. Patient #10 On 2/26/2024 at 11:10 AM, while administering IV heparin to Patient #10, Employee #13 was observed removing the IV port cap, connecting heparin syringe to the IV port, administering heparin into the access line, disconnecting the heparin syringe from the access line, and capping the IV port. During an interview on 2/26/2024 at 11:10 AM, Employee #13 confirmed he/she did not disinfect the IV port before administering heparin to Patient #10.”

“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: 47821 Based on observation, policy review and staff interview, it was determined that the facility failed to maintain a safe, functional, and comfortable environment for 60 patients and 16 staff at this facility. Findings include: A. The facility policy titled “Housekeeping” dated 03/20/2013 stated, “...Solutions will be stored and labeled appropriately...”. The facility policy titled “General Cleanliness and Infection Control Guidelines” dated 02/07/2022 stated, “...All areas must be kept clean and organized, including but not limited to the treatment area...Walkways must be kept clear of debris and free of clutter...” The facility policy titled “Compressed Gas Storage & handling Program” dated, 8/15/2021 stated, “...All compressed gas cylinders in service or storage at the user location shall be secured from falling...” B. During an environmental tour of the patient treatment area on 2/26/2024 between 8:40 AM and 1:20 PM the following was observed: a. Supply room door partially blocked by Hoyer lift. b. Spray bottle on bleach cart next to nurse station with clear liquid. Bottle not labeled. These findings were confirmed with Employee #6 on 2/26/2024 at 9:25 AM. c. 1 (one) empty spray bottle in isolation room. Bottle not labeled. This finding was confirmed with Employee #6 on 2/26/2024 at 9:55 AM. C. During a flash tour of the treatment area on 2/26/2024 at 8:45 AM, the following was observed immediately outside the clinic manager’s door: a. One (1) oxygen tank that was not in use, not secured in an oxygen tank holder. b. Staff interview with Employee #3 RN, on 2/26/2024 at 10:14 AM revealed that “Sometimes oxygen cylinders come in with patients on stretchers, and there are no holders with them”. This finding was confirmed at the time of discovery on 2/26/2024 at 08:45 AM.”

“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: 47821 Based on observation, policy review and staff interview, it was determined that the facility failed to maintain a functional environment for 60 patients and 16 staff at this facility. Findings include: A. The facility policy titled “Equipment Installation-Operation -Maintenance Repair and Disposal” dated 07/06/21 stated, “... all equipment will be installed, operated, maintained, and repaired in accordance with manufacturer’s instructions...” B. During an environmental tour on 2/26/24 between 8:40 AM and 1:20 PM the following was observed: - Two (2) water fountains identified as out of order in the lobby waiting area. This finding was confirmed by Employee #9 on 2/27/24 at 11:10 AM. -One broken hand wash sink cabinet in the soiled utility room. Cabinet door was not secured to cabinet. This finding was confirmed by Employee #6 on 2/26/24 at 9:25 AM.”

“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: 47821 Based on observation, facility document review, policy review and staff interview, it was determined that the facility failed to maintain, operate and have all equipment readily accessible in order to provide a functional environement for 60 patients and 16 staff at this facility. Findings include: A. The facility policy titled “Hand Hygiene” dated 11/06/23 stated, “...A sufficient number of sinks with soap and plumbed with both hot and cold water shall be available to facilitate hand washing...”. The facility policy titled “Equipment Installation-Operation -Maintenance Repair and Disposal” dated 07/06/21 stated, “... Any equipment or device that is not fully functioning in accordance with IFU [manufacturer’s instructions for use] or company policy, must be repaired or replaced as soon as reasonably possible...Any equipment awaiting repair must be tagged in accordance with Use of Hemodialysis and Ancillary Machine Repair /Return Tag Policy...”. The facility policy titled “General Cleanliness and Infection Control Guidelines” dated 2/07/2022 stated, “...All areas must be kept clean and organized, including but not limited to the treatment area...Walkways must be kept clear of debris and free of clutter...” B. During an environmental tour on 2/26/24 between 8:40 AM and 1:20 PM the following was observed: a. Treatment floor supply room: - Observed hand wash sink blocked by cardboard boxes on floor in front of sink. Hand wash sink was not easily accessible. b. Supply storage room: - Observed 1 (one) patient reclining chair with a 1-inch tear in the upholstery. Tear located in the middle of the back support with foam exposed. Surface is unable to cleaned and sanitized for patient use. - Observed said patient reclining chair not tagged for use, repair or replacement. This finding was confirmed at time of discovery by Employee #9 on 2/26/24. c. Water room: - Observed eye wash station blocked by a pallet. Eye wash not easily accessible by staff. - Observed hand wash station blocked by a pallet. Hand wash station not easily accessible by staff. These findings were confirmed at time of discovery by Employee #9 on 2/26/24.”

“PR-RECEIVE SERVICES OUTLINED IN POC CFR(s): 494.70(a)(12) The patient has the right to- (12) Receive the necessary services outlined in the patient plan of care described in §494.90; This Standard is not met as evidenced by: 47821 Based on review of medical records, review of facility policies and documents, and staff interview, it was determined that the facility failed to complete documentation on AMA (Against Medical Advice/Leaving treatment early) forms for 1 of 12 patients (Patient #1) in the medical record review sample. Findings include: The facility policy titled “Medical Record Documentation Standards” dated 2/2020 stated, “...Responsibility All ...persons who document in the patient’s medical record...must monitor and maintain complete, accurate...records on all patients ...document all facts and pertinent information related to...course of treatment...”. Facility policy titled “Early Termination or Arriving Late for Treatment” dated 11/07/2022, stated “...the RN [Registered Nurse] who evaluates the patient must document the rationale for early termination...reinforce the consequences...complete documentation on Early Termination of Treatment Against Medical Advice Form...” Review of AMA forms in the medical record for Patient #1 revealed: A. Form dated 1/26/2024: no time documented. B. Form dated 8/7/2023: no time or reason for early termination documented. C. Form dated 8/11/2023: no reason for early termination documented. D. Form dated 4/24/2023: no reason for early termination documented. E. Form dated 4/22/2023: no time documented. F. Form dated 4/21/2023: no reason for early termination documented. In an interview conducted with Employee #1 on 2/28/2024 at 1:30 PM, Employee #1 stated that the staff is responsible for documenting the reason for early termination along with the time on the AMA form. These findings were confirmed by Employee # 6 on 2/28/2024 at 1:50 P.M.”

“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: 47821 Based on medical record review, policy review and staff interview, it was determined that for 1 of 12 patients (Patient #2) in the medical record review sample, the dialysis treatment was shortened with no evidence of physician notification or of a signed AMA [Against Medical Advice] form. Findings include: A. Review of facility policy titled “Early Termination or Arriving Late for Treatment” dated 11/07/2022 revealed, “...The RN [Registered Nurse] who evaluated the patient must document the rationale for early termination of treatment and reinforce the consequences of not receiving the entire prescribed treatment. The RN is responsible to notify the physician, and document on the AMA, [Against Medical Advice] form ...Against Medical Advice forms are...Signed with each early termination event and filed in the patient’s medical record...”. B. On 1/23/2024 Patient #2 received 2 hours and 45 minutes of dialysis. -The prescribed treatment time for the patient was 3 hours and 30 minutes. -The patient’s treatment was 45 minutes less than ordered. -Employee #15 entered the following note at 3:43 PM, “UF [ultrafiltration] off, treatment discontinued without problem.” -There was no evidence of the patient having signed an AMA form. This finding was confirmed with Employee #1 on 2/27/2024 at 2:30 PM. C. On 1/25/2024 Patient #2 received 2 hours and 51 minutes of dialysis. -The prescribed treatment time for the patient was 3 hours and 30 minutes. -The patient’s treatment was 39 minutes less than ordered. -Employee #19 entered the following note at 3:45 PM, “Treatment discontinued without problem, access visible.” -There was no evidence of the patient having signed an AMA form. This finding was confirmed with Employee #1 on 2/27/2024 at 2:30 PM. D. On 1/27/2024 Patient #2 received 3 hours of dialysis. -The prescribed treatment time for the patient was 3 hours and 30 minutes. -The patient’s treatment was 30 minutes less than ordered. -Employee #10 entered the following note at 3:47 PM, “Access visible, denies complaints, UF off, patient alert, treatment discontinued without problem, treatment ended.” -There was no evidence of the patient having signed an AMA form. This finding was confirmed with Employee #1 on 2/27/2024 at 2:30 PM. E. On 1/30/2024 Patient #2 received 2 hours and 59 minutes of dialysis. -The prescribed treatment time for the patient was 3 hours and 30 minutes. -The patient’s treatment time was 31 minutes less than ordered. -Employee #15 entered the following note at 3:45 PM, “UF off, treatment discontinued without problem.” -There was no evidence of the patient having signed an AMA form. This finding was confirmed with Employee #1 on 2/27/2024 at 2:30 PM. F. On 2/17/2024 Patient #2 received 2 hours and 55 minutes of dialysis. -The prescribed treatment time for the patient was 3 hours and 30 minutes. -The patient’s treatment time was 35 minutes less than ordered. -Employee #12 entered the following note at 3:40 PM, “Ended.” -There was no evidence of the patient having signed an AMA form. This finding was confirmed with Employee #1 on 2/27/2024 at 2:30 PM.”

“MR-COMPLETE, ACCURATE, ACCESSIBLE CFR(s): 494.170 The dialysis facility must maintain complete, accurate, and accessible records on all patients, including home patients who elect to receive dialysis supplies and equipment from a supplier that is not a provider of ESRD services and all other home dialysis patients whose care is under the supervision of the facility. This Standard is not met as evidenced by: 47821 Based on medical record review, policy review, and staff interview, it was determined that for 1 of 12 (Patient #12) patients in the medical record review sample, staff failed to enter complete and accurate medical record documentation. Findings include: A. Facility policy titled “Medical Record Documentation Standards” dated 2/5/2024 stated, “...All...persons who document in the patient’s medical record...must...maintain complete, accurate...records on all patients...” Facility policy titled “Patient Assessment and Monitoring” dated 5/1/2023 stated, “...The Registered Nurse [RN] will assess/re-assess any findings addressed pre or during treatment as needed...” B. Patient #12 A review of the “Treatment Sheet” dated 2/6/24 for treatment that started at 11:34 AM revealed: - Hemodialysis (HD) orders included an edw (estimated dry weight) of 106.50 kilograms (kg) and scheduled hours of 4:00. - 1:53 PM, the Patient experienced “...cramping...” that required 100mL of fluid administration and UF (ultrafiltration) turned off - 1:56 PM, the Patient experienced “...severe cramping...” with UF still off that required 300mL of fluid administration - 2:12 PM, Patient’s “...cramping has subsided, UF back on...” - 3:11 PM, treatment ended after 3 hours 36 minutes with Patient’s weight 108.6 kg - Employee #13’s post-treatment nursing evaluation dated 2/6/24 at 4:29 PM stated “...Pt [patient] tolerated tx [treatment] without incident...Pt post weight 2.1 kg over edw” During an interview on 2/28/24 between 11:20 and 11:55 AM, Employee #1 confirmed that Employee #13’s post-treatment evaluation did not accurately document findings addressed during the treatment.”