Fkc Greentree

“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: 22676 Based on observation, interview, and facility policy review, the facility failed to ensure that staff and patients used hand sanitizer or washed their hands on one of three survey days. This deficient practice had the potential to result in increased infections in all 58 patients receiving care at this incenter hemodialysis unit. Findings include: Review of the policy titled, “Hand Hygiene,” dated 11/06/23, stated, “All staff, patients ... must follow the same requirements for hand hygiene... Hands will be...decontaminated with alcohol-based hand rub or by washing hands...when...Entering and leaving the treatment area, before performing any invasive procedure such as vascular access canulation or administration of medications, immediately after removing gloves, after contact with body fluids ...” 1. Observation on the treatment unit on 02/24/25 at 10:20 AM revealed Patient (P) 4 at Station 13 was observed holding his/her site post dialysis treatment. Certified Clinical Hemodialysis Technician (CCHT) 12 assisted the patient in wheelchair and took him/her to weigh, he/she was then seen taking the patient to the lobby for discharge. CCHT12 did not ensure the patient used hand sanitizer or washed their hand prior to leaving the unit. An interview with CCHT12 on 02/24/25 at 10:25 AM confirmed he/she failed to ensure the patient sanitized hands after the patient held his/her dialysis access site. 2. Observation on 02/24/25 at 10:22 AM revealed P6 sat at Station 6 holding his/her vascular access site with his/her left gloved hand, post hemodialysis treatment. Patient Care Technician (PCT)13 reinforced the dressing to the patient’s vascular access (a vascular access that involves the insertion of a flexible and sterile thin plastic tube, or catheter, into a blood vessel), removed the patient’s contaminated glove, assisted the patient with his/her walker and accompanied the patient to the scale to be weighed. PCT13 did not encourage/ instruct the patient to sanitize his/her hands after removing the contaminated glove. During weighing, P6 held the grab bar at the scale with his/her contaminated hand. The patient left the station without washing or sanitizing his/her hands after holding his/her vascular access site. During an interview on 02/24/25 at 10:45 AM with PCT13, the Surveyor informed him/her that the patient was not encouraged or instructed to wash/sanitize his/her hands after removing contaminated glove used to hold vascular access site. PCT13 stated, “Normally I don ’ t, sometimes they gel but I did not tell [him/her].” 3. Observation on 02/24/25 at 10:24 AM revealed P8 sat at Station 2 holding his/her vascular access site with his/her left gloved hand, post hemodialysis treatment. Observation on 02/24/25 at 10:34 AM revealed that CCHT9 reinforced the dressing to the patient’s vascular access site with tape, removed the patient’s contaminated glove, and assisted him/her to the wheelchair. CCHT9 did not encourage or instruct the patient to wash/sanitize his/her hands after removing the contaminated glove. CCHT9 pushed the patient to the scale. During weighing, P8 held the grab bar at the scale with his/her contaminated hand. The patient left the station without washing or sanitizing his/her hands after holding his/her vascular access site. During an interview on 02/24/25 at 10:40 AM with CCHT9, the Surveyor informed him/her that the patient was not encouraged or instructed to wash/sanitize his/her hands after removing the contaminated glove used to hold his/her vascular access site. CCHT9 stated, “I didn’t, I didn’t, I should.””

“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: 22676 Based on observation, interview and policy review, the facility failed to ensure the hemostats and clamps used in patient care were disinfected on one of three survey days appropriately. These findings have the potential to cause harm to all 58 patients receiving care at the facility. Findings include: Review of the facility’s policy titled “Cleaning and Disinfecting the Dialysis Station” dated 09/05/23 stated, “Place used plastic pressure clamps and plastic hemostat clamps in a labeled opaque plastic container filled with a 1:100 bleach solution per the Mixing Bleach policy. Make sure the items are completely submerged, unclamped, and in the open position when placed in the solution. Allow items to soak in the solution for at least l0 minutes” Observation on the treatment floor on 02/24/25 at 11:30 AM revealed the hemostats used in patient care were observed to be soaking in the disinfectant in the closed position versus the open (unclamped) position to ensure adequate disinfectant of the interior surface of the clamp. In addition, there were numerous clean clamps observed in the strainer in the closed position. In an interview with Certified Clinical Hemodialysis Technician (CCHT) 12 on 02/24/25 at 11:30 AM, CCHT12 confirmed the clamps were soaking in the disinfectant in the closed position and the clean clamps in the strainer were in the closed position. CCHT12 stated he/she did not know they needed to be in the unclamped positions.”

“IC-DISINFECT SURFACES/EQUIP/WRITTEN PROTOCOL CFR(s): 494.30(a)(4)(ii) [The facility must demonstrate that it follows standard infection control precautions by implementing- (4) And maintaining procedures, in accordance with applicable State and local laws and accepted public health procedures, for the-] (ii) Cleaning and disinfection of contaminated surfaces, medical devices, and equipment. This Standard is not met as evidenced by: 52387 Based on observation, interview, and review of facility policy, the facility failed to ensure direct care staff cleaned and/or sanitized the prime buckets, Hansen connectors, blood pressure cuff, water hoses, sharp container attached to the hemodialysis machines, and chase (a space-saving wall chase system configured using the wall box to connect plumbing lines in a dialysis treatment facility to dialysis machines) during terminal cleaning of contaminated hemodialysis units for two of two direct care staff (Patient Care Technician (PCT)13 and Certified Clinical Hemodialysis Technician (CCHT)10) observed terminally cleaning hemodialysis units. Findings include: A review of the facility’s policy titled, “Cleaning and Disinfecting Dialysis Station,” dated 09/05023, indicated, “Purpose: The purpose of this policy is to provide guidelines to prevent the spread of infectious disease in accordance with appropriate regulations, and maintain a clean, safe and aesthetically pleasant environment for patients, staff and visitors...Externally disinfect the dialysis machine with 1:00 bleach solution after each dialysis treatment ...” 1. Observation on 02/24/25 at 10:47 AM revealed PCT13 was observed terminally cleaning contaminated hemodialysis Station 6 post-hemodialysis treatment of a patient. The PCT13 did not clean/disinfect prime buckets (a container used to collect saline solution that is used to flush and prime dialysis machine), Hansen connectors (fitting that connects a dialyzer), blood pressure cuff, water hoses, and sharps container attached to the hemodialysis machines. Subsequent observation on 02/24/25 at 10:52 AM revealed that PCT13 was observed preparing Station 6 for an oncoming patient. While stringing the external bloodlines into the compartment of the hemodialysis machine, a portion of the external bloodline fell to the floor. PCT13 wearing a pair of gloves, retrieved the portion of the external blood lines that fell to the floor and discarded it, then retrieved a new packet containing external blood lines from the stock cart with the contaminated gloves used to retrieve the external blood lines from the floor. Then PCT13, wearing the contaminated gloves, strung the hemodialysis machine and primed the external bloodlines with Normal Saline Solution in preparation for an oncoming patient. Observation on 02/24/25 at 11:05 AM revealed that PCT13 accompanied a patient to Station 6 for hemodialysis treatment. During an interview on 02/24/25 at 11:06 AM with PCT13, when informed he/she did not clean/disinfect the prime bucket, Hansen connectors, blood pressure cuff, water hoses, and the sharps container attached to the hemodialysis machine during terminal cleaning of the contaminated hemodialysis unit, PCT13 stated, “I am sorry.” 2. Observation on 02/24/25 at 10:55 AM revealed CCHT10 was observed terminally cleaning contaminated hemodialysis Station 5, post-hemodialysis treatment of a patient. Observation revealed that CCHT10 did not clean/disinfect Hansen connectors (disconnect fitting that connects a dialyzer), water hoses, and chase during terminal cleaning of the hemodialysis unit. During an interview on 02/24/25 at 11:08 AM with CCHT10, when the Surveyor informed him/her that the observation revealed that he/she did not clean/disinfect Hansen connectors, water hoses, and chase during terminal cleaning of contaminated hemodialysis units, CCHT10 stated, “I forgot.””

“ENVIRONMENT-SECURE & RESTRICTED CFR(s): 494.40(a) 8 Environment: secure & restricted The water purification and storage system should be located in a secure area that is readily accessible to authorized users. The location should be chosen with a view to minimizing the length and complexity of the distribution system. Access to the purification system should be restricted to those individuals responsible for monitoring and maintenance of the system. This Standard is not met as evidenced by: 35426 Based on observation, interview, and review of the facility policy, the facility failed to ensure access to the water room was restricted and secured for authorized users only. This failure has the potential to negatively affect all 58 patients receiving Incenter Hemodialysis at the facility. Findings include: A review of “Physical Security and Facility Access” with an original date of 09/05/23, revealed, “...Water Treatment Area Security: Restricted access must be maintained to prevent unwanted tampering with the water treatment equipment. The facility must be maintained to prevent unwanted entry by outside persons not involved in the daily operation of the clinic. This is accomplished by: Locking all doors that allow access to the water treatment equipment. No exterior building door will be left unlocked unless under the continual supervision of a facility staff member. Non-FKC [Fresenius Kidney Care] employees and third-party personnel who repair/maintain water treatment equipment or deliver supplies in the water treatment area must be monitored at all times by a FKC employee while in the area...” During a tour of the facility on 02/24/25 at 9:30 AM, accompanied by the Facility Administrator, the third door to the water room area was unsecured. The door handle had a key lock mechanism which was in the lock position, however, the door latch was not secure. The doors were not fitting/closing securely, which allowed access into the water room area. The door had signs posted that read “Mechanical Room” and “Authorized Personnel Only.” During an observation and interview with the Facility Administrator on 02/24/25 at 9:30 AM, he/she verified that the water treatment area was not secured. During an interview on 02/24/25 at 9:40 AM with Biomedical Technician (BT-6), he/she was not aware that the door was not secured. He/she further stated that there is not a key for the lock and the door is locked from the inside of the room only. The door entry is where the water room supplies are delivered. He stated the delivery people may have knocked the door accidentally causing it not to latch properly. The authorized staff gives access to the delivery of supplies and remains present during the delivery process. The video monitor in the office shows who is in the water room.”

“MIXING SYSTEMS-LABELING CFR(s): 494.40(a) 5.4.4.1 Mixing systems: labeling Labeling strategies should permit positive identification by anyone using the contents of mixing tanks, bulk storage/dispensing tanks, and small containers intended for use with a single hemodialysis machine. Mixing tanks: Prior to batch preparation, a label should be affixed to the mixing tank that includes the date of preparation and the chemical composition or formulation of the concentrate being prepared. This labeling should remain on the mixing tank until the tank has been emptied. Bulk storage/dispensing tanks: These tanks should be permanently labeled to identify the chemical composition or formulation of their contents. Concentrate jugs: At a minimum, concentrate jugs should be labeled with sufficient information to differentiate the contents from other concentrate formulations used at the facility. This Standard is not met as evidenced by: 35426 Based on observation, interview, and review of the facility’s policies and procedures, the facility failed to ensure that a bicarbonate jug was labeled with date, time and initials of the person preparing the jug when in use for one of 16 dialysis station. This failure prevented the identification of the person who filled the jug of bicarbonate and expiration time. Findings include: Review of the facility’s policy “Bicarbinate Concentrate Mixing” original date 07/01/24, indicated, “Bicarbonate jugs, mixers and SDS [Solution Delivery System] will be labeled in accordance with ‘Concentrate Labeling Requirements.’ “ Review of the facility’s policy “Concentrate Labeling Requirements” dated 9/5/23, indicated, “...Mix tank labeling must include...Date and time of mixing...” During the facility tour on 02/24/25 at 9:45 AM, accompanied by the Facility Administrator, a bicarbonate jug was in use at Station 13. The label did not have a date or time listed. During an interview and observation on 02/24/25 at 9:45 AM with the Facility Administrator and Patient Care Dialysis Technician (PCT)12, both verified the label on the jug of bicarbonate was not labeled with a date, time and initial of the person preparing the Bicarbonate jug for use.”

“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: 52387 Based on observation, medical record review, and interview, the facility’s direct care staff failed to 1. administer patients’ hemodialysis treatment based on the patient’s physician’s orders in two of seven sampled patients (Patient (P) 2 and P7) and 2. the facility’s Registered Nurse (RN) failed to conduct intradisciplinary and post-treatment assessments on a patient who experienced a change in condition during hemodialysis treatment in one of seven sampled patients (P5). Findings include: Review of the facility’s policy and procedure titled, “Nursing Supervision and Delegation,” indicated, “The staff member who collects information pre, post, and during treatment will document their findings. Any observed changes or abnormal findings in the patient’s condition or vascular access, changes reported by the patient, recent hospitalizations, or other medical procedures (ex. Dental procedures) must be reported to the registered nurse who will assess the patient. Registered nurses who are not the nurse in charge must report abnormal findings and interventions to the nurse in charge.” On 02/24/25 at 11:26 AM, P2 was observed at Station 2 in the hemodialysis treatment unit. The Surveyor requested Certified Clinical Hemodialysis Technician (CCHT)10 open the panel on the hemodialysis machine to validate the patient’s hemodialysis prescription. Review of the patient’s prescription located on the computer attached to the hemodialysis machine revealed a prescription for dialysate concentrate of bicarbonate 40 Milliequivalents per liter (mEq a unit used to measure the concentration of a substance in a solution), (Sodium bicarbonate is a white, crystalline powder that is commonly used as a pH buffering agent, an electrolyte replenisher, systemic alkalizer and in topical cleansing solutions.) Observation of the bicarbonate setting on the hemodialysis machine revealed that the hemodialysis machine was set to deliver bicarbonate 33mEq and not the prescribed order of 40 mEq/L. During an interview on 02/24/25 at 11:30 AM with the Facility’s Charge Nurse, after reviewing the patient’s prescription, he/she stated, “You are correct, the bicarbonate is not set at the correct prescription.” During an observation and interview on 02/24/25 at 11:37 AM, Registered Nurse (RN)8, who is assigned to P2, revealed, “Two people checked the prescription, it should be 40, I did not check the prescription.” Observation of the hemodialysis panel opened by RN8 revealed the hemodialysis machine was set to deliver bicarbonate 33mEq/liter and not 40mEq/l as prescribed. 2. On 02/25/25 at 9:10 AM, P7 was observed at Station 12, in the hemodialysis treatment unit. The Surveyor requested CCHT9 open the panel on the hemodialysis machine to validate the patient’s hemodialysis prescription. Review of the patient’s prescription located on the computer attached to the hemodialysis machine, revealed a prescription for dialysate concentrate of Bicarbonate 36 mEq/L and Sodium of 135 mEq/L. Observation of the bicarbonate setting on the hemodialysis machine revealed the hemodialysis machine was set to deliver bicarbonate at 35mEq/L and not the prescribed order of 36 mEq, and the sodium was set to deliver at 136 mEq. An interview on 02/25/25 at 11:37 AM with RN8, who is assigned to P7 revealed, “The prescription for bicarbonate and sodium are set incorrectly.” 3. Review of P5’s hemodialysis treatment sheet, dated 02/24/25, revealed the following documentation: Pre-hemodialysis treatment nursing evaluation conducted by RN8 at 6:40 AM with findings of, “Rales (crackles)” to the patient’s lungs and edema (swelling) to bilateral ankles and lower legs. The record revealed the patient was administered oxygen 2 liters via nasal cannula. The record revealed the following pre-treatment pulse and blood pressure: Blood pressure 116/69 sitting, 121/69 standing, pulse 67. Documentation revealed P5’s hemodialysis treatment was initiated by CCHT9 on 02/24/25 at 6:23 AM. Documented intradialytic (BP) blood pressure and pulse were as follows: 6:26 AM; BP 122/76, pulse 67 7:06 AM; BP 102/57, pulse 66 7:23 AM; BP 92/49, pulse 75 7:42 AM; BP 91/49, pulse 73 8:06 AM; BP 96/53, pulse 69 8:23 AM; BP 97/52, pulse 74. CCHT 9 documented “ SOB; Oxygen (Liters) /min): Nasal. Cannula 1.5.” 8:49 AM; BP 93/55, pulse 75, 9:02 AM; BP 94/44, pulse 72 9:24 AM; BP 91/53, pulse 75 9:42 AM; BP 94/46, pulse 76 10:03AM; BP 90/53, pulse 77 10:22AM; BP 96/56, pulse 75 10:34 AM; BP 94/49 pulse, 75. P5’s hemodialysis treatment was terminated by CCHT8. Review of the P5’s hemodialysis treatment sheet revealed no documentation that CCHT8 notified the RN assigned to the patient of the decrease in blood pressure and that the RN conducted an intradialytic assessment during hemodialysis treatment. Review of a “Multidisciplinary Note” by RN8 revealed the following documentation “Pt [patient] completed Tx [treatment] w/o [without] incident. Pt dc’d [discharged] 0.4 kg [kilogram]over EDW [estimated dry weight].” On 02/25/25 at 11:00 AM P5’s treatment sheet was reviewed with the Facility’s Regional Operational Director. He/She confirmed that the RN should have assessed the patient intradialytic and post-hemodialysis treatment.”

“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: 22676 Based on medical record review, interview, and policy review, the facility failed to follow the individualized dialysis plan (an artificial means of kidney function that removes the waste and excess fluid from the blood by passing through a filter) by following the physician’s prescription as determined by the medical provider for one of seven sampled in-center dialysis patients (Patient (P)1). Failure to follow the medical providers’ dialysis prescription had the potential to negatively impact the effectiveness of the prescribed dialysis treatments for all 58 patients receiving in-center dialysis treatments at this facility. Findings include: Review of the facility’s policy titled, “Patient Assessment and Monitoring” dated 05/01/23 revealed, “Check dialysate flow rate setting is correct, and the correct prescribed flow is being delivered ...” Review of P1’s electronic medical record (EMR) revealed a prescribed Blood Flow Rate (BFR) of 400 milliliters per minute (ml/min) and a Dialysis Flow Rate of Autoflow of 1.5 the BFR, which should be 600 ml/min. Review of two of five “Post Treatment” flowsheets from 02/12/25 through 02/24/25 in the EMR indicated the following: a. On 02/21/25 from 8:08 AM until 9:20 AM, the DFR was documented at 800 ml/min. There was no documentation for the change to the prescribed DFR. b. On 02/24/25, from 8:21 AM until 11:03 AM, the DFR was documented at 800 ml/min. There was no documentation for the change to the prescribed DFR. During an interview on 02/26/25 at 10:15 AM, Regional Operation Director 2, confirmed the above findings that staff did not follow the physician’s order for dialysis treatment.”

“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: 22676 Based on observation, staff interview, and facility policy review, the facility failed to ensure that staff and patients washed their access on arrival to the treatment unit on one of three survey days. This deficient practice has the potential to result in increased infections in all 58 patients receiving care at this incenter hemodialysis unit. Findings include: Review of the policy titled, “Access Assessment and Cannulation” dated 05/06/24 stated, “Prior to treatment, ask patient to wash access area with soap and water, per hand hygiene procedure. If the patient is unable to wash their own access, the staff or care partner should wear gloves to wash the patient’s access with soap and water.” Observation of the treatment unit on 02/24/25 at 11:05 AM: Patient (P) 3 was seen entering the treatment unit and taken to Station 13. Certified Clinical Hemodialysis Technician (CCHT)12 assisted and was then seen cannulating the access without ensuring the patient washed his/her access when entering the unit and prior to cannulation. An interview with CCHT12 on 02/24/25 at 11:15 AM confirmed he/she failed to ensure the patient washed his access prior to cannulation.”