Fmc North Haven Dialysis Center

“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: 44675 Based on observations, review of clinical records, interview, and policy review for one (1) of six (6) hemodialysis patients reviewed for hand hygiene (Patient #10), the facility failed to perform hand hygiene and encourage hand hygiene post treatment in accordance with facility policy, and staff failed to change gloves when appropriate and perform hand hygiene in between glove changes. The findings include the following: 1. Patient #10 had diagnoses that included end stage renal disease (ESRD). Review of the physician’s orders directed hemodialysis three (3) times weekly for four (4) hours with a Right Arteriovenous Fistula (AVF). Observation conducted on 2/26/25 at 11:31 AM of Station #10 identified Patient #10 holding his/her access site post treatment with gloves. Patient #10’s gloves were removed, and Staff Person #1 did not offer hand hygiene to Patient #10. Patient #10 then proceeded to the scale, with Staff Person #1, to weigh and touched the scale without the benefit of hand hygiene. 2. Patient #12 had diagnoses that included ESRD. Review of the physician’s orders directed hemodialysis treatments three times weekly for three (3) hours and thirty (30) minutes utilizing a left upper arm AVF. Observation conducted on 2/26/25 at 9:21 AM of Station #6 identified Staff Person #1 discontinuing Patient #12’s hemodialysis treatment. Staff Person #1 was observed removing the blood pressure cuff from Patient #12’s lower left extremity, moving it to the patient’s right arm, folding Patient #12’s blankets, and removing the blood pressure cuff from the patient’s right arm. Staff Person #1 then proceeded to disconnect the dialysis tubing from the needles, remove the bandages and needles from the patient’s access, apply new bandages, tape, and a clamp to the arterial cannulation site without changing his/her gloves, performing hand hygiene, and applying new gloves. 3. Observation conducted on 2/26/25 at 10:05 AM identified Staff Person #4 removing his/her gloves and walking into Dialysis Station #1 to apply new gloves, however, Staff Person #4 failed to perform hand hygiene prior to applying the new gloves. Staff Person #4 then proceeded to change the bicarb bag on Station #1’s dialysis machine and entered data into the computer located in Station #1 prior to removing his/her gloves and performing hand hygiene. Interview with the Clinical Coordinator on 2/26/25 at 3:01 PM identified staff should perform hand hygiene following glove removal and prior to putting on new gloves. The Clinical Coordinator further indicated that gloves should be changed and hand hygiene performed prior to removing needles, when staff’s hand come into contact with the patient’s personal items and the blood pressure cuff. Review of the Hand Hygiene policy directs hands will be decontaminated using alcohol-based hand rub or by washing hands with antimicrobial soap and water before and after direct contact with patients, immediately after removing gloves, after contact with body fluids or excretions, and after contact with inaminate objects near the patient. The policy further direcxts patients should perform hand hygiene if able, prior to and after each dialysis treatment.”

“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: 47491 Based on observations and policy review, the facility failed to ensure adequate disinfection of the dialysis station in between patient use. The findings included: a) Observation on 2/26/25 at 9:28 AM of the disinfection of Station # 9 failed to identify that the prime bucket, the tubing in front of the machine, and the Hansen tubing on the side of the machine were disinfected following Patient #11’s treatment. b) Observation on 2/26/25 at 11:55 AM of the disinfection of Station # 12 by Staff Person #3 failed to identify that the tubing in front of the dialysis machine, the Hansen tubing on the side of the machine, television, and television arm were disinfected following Patient #13’s treatment. c)Observations conducted on 2/25/25 at 11:31 AM identified Staff Person #15 disinfecting dialysis Station #1 after a patient hemodialysis treatment. Staff Person #15 failed to clean and disinfect the sharps container attached to the machine on the right side. d) Observations conducted on 2/26/25 at 11:34 AM identified Staff Person #1 disinfecting dialysis Station #10 after a patient hemodialysis treatment. Staff Person #1 failed to clean and disinfect the top of the IV pole, the stethoscope hanging on the IV pole, the sharps container attached to the machine on the right side, the drain lines connecting from the machine to the wallbox and the back counter. Review of the Cleaning and Disinfection the Dialysis Station policy directed the dialysis station includes the dialysis machine, attachments such as IV pole, BP cuff, hand sanitizer, organizer, bed, individual television, and remote. It directed after use, any non-disposable equipment and supplies brought into the dialysis station must be disinfected with 1:100 bleach or EPA registered disinfectant.”

“IC-CATHETERS:GENERAL CFR(s): 494.30(c)(2) (2) The “Guidelines for the Prevention of Intravascular Catheter-Related Infections” entitled “Recommendations for Placement of Intravascular Catheters in Adults and Children” parts I - IV; and “Central Venous Catheters, Including PICCs, Hemodialysis, and Pulmonary Artery Catheters in Adult and Pediatric Patients,” Morbidity and Mortality Weekly Report, volume 51 number RR-10, pages 16 through 18, August 9, 2002. The Director of the Federal Register approves this incorporation by reference in accordance with 5 U.S.C. 552(a) and 1 CFR Part 51. This publication is available for inspection as the CMS Information Resource Center, 7500 Security Boulevard, Central Building, Baltimore, MD or at the National Archives and Records Administration (NARA). Copies may be obtained at the CMS Information Resource Center. For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal_register/code_of_regulations/ibr_locations.html This Standard is not met as evidenced by: 47491 Based on observations, interview, and review of facility policy for one (1) of two (2) patients (Patient #11), the facility failed to ensure a patient’s mask was donned properly when disconnecting treatment lines from a patient’s central venous catheter (CVC). The findings included: Patient #11 had diagnoses that included end stage renal disease. Review of the physician’s orders directed hemodialysis three times weekly for three (3) hours utilizing a central venous catheter (CVC). Observation conducted on 2/26/25 at 9:13 AM identified Staff Person #2 disconnecting Patient #11’s CVC from both the arterial and venous blood lines at the end of his/her hemodialysis treatment. Although Patient #11 had his/her mask applied properly during disconnection of the arterial line from his/her CVC, his/her mask was only covering his/her mouth during the disconnection of the venous line from his/her CVC and when inserting heparin solution into each limb of the CVC. Patient #11 properly reapplied his/her mask during the capping of the arterial CVC limb, however his/her mask and had again slid off his/her nose during the capping of the venous limb. Interview with the Clinical Coordinator on 2/26/25 at 3:01 PM identified patients should have their mask properly applied, covering both their mouth and nose completely, throughout the CVC connection and disconnection procedure.”

“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: 41746 Based upon observation and subsequent staff interview on 02/24/25 at approximately 1:30 PM, the facility failed to ensure that 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. The findings include: The required fire/smoke barrier between the admin hallway and the treatment floor had large voids and penetrations from the water treatment system above the lay in ceiling that were not sealed and/or repaired as required by the 2012 NFPA 101 “Life Safety Code” 8.5.6., subsequent to this observation at approximately 1:45 PM interview of the Regional Biomedical Tech identified this had occurred during a upgrade of the water system & treatment loop.”

“PA-APPROPRIATENESS OF DIALYSIS RX CFR(s): 494.80(a)(2) The patient’s comprehensive assessment must include, but is not limited to, the following: (2) Evaluation of the appropriateness of the dialysis prescription, This Standard is not met as evidenced by: 44675 Based on a review of clinical records, interview, and policy review for three (3) of eight (8) hemodialysis patients reviewed for prescriptions (Patient #2, #5, and #6), the facility failed to ensure the patient’s hemodialysis treatment was delivered in accordance with the physician orders. The findings include the following: 1. Patient #2 had diagnoses which included end stage renal disease. A physician’s order for hemodialysis treatment three (3) times weekly utilizing a tunneled central venous catheter in the chest for three (3) hours and thirty (30) minutes, a 2.0 potassium/2.5 calcium dialysate bath, blood flow rate (BFR) of 400, and an autoflow 1.5 dialysate flow rate (DFR). A review of Patient #2’s treatment flowsheets identified the following: a. On 2/18/25, treatment was initiated at the prescribed BFR of 400, however was decreased to a BFR of 350 for one (1) hour and twenty -three (23) minutes without documenting the reason for the decreased BFR. b. On 2/11/25, treatment was initiated at the prescribed BFR of 400, however was decreased to a BFR of 300 for thirty-one (31) minutes, and then to a BFR of 250 for fifty-nine (59) minutes without documenting the reason for the decreased BFR. c. On 2/7/25, treatment was initiated at a BFR of 350, was lowered to a BFR of 250 twenty-seven (27) minutes later, then increased to a BFR of 350 sixty-seven (67) minutes later and remained at a BFR of 350 for the remainder of the treatment without documenting the reason for the adjustments made to Patient #2’s BFR. 2. Patient #4 had diagnoses which included end stage renal disease. A physician’s order for hemodialysis treatment three (3) times weekly utilizing a left upper arm arteriovenous graft in the left upper arm for four (4) hours and fifteen (15) minutes, a 3.0 potassium/2.5 calcium dialysate bath, blood flow rate (BFR) of 450, and an autoflow 1.5 dialysate flow rate (DFR). A review of Patient #4’s treatment flowsheets identified the following: a. On 1/25/25, treatment was initiated at a BFR of 200, increased to a BFR of 300 fifteen (15) minutes later, increased to a BFR of 450 fifty-nine(59) minutes later, then decreased to a BFR of 400 two (2) hours and three (3) minutes later, and again increased to a BFR of 450 twenty-seven (27) minutes later without documenting the reason for the changes made to the BFR. b. On 1/28/25, treatment was initiated at a BFR of 400 and maintained at a BFR of 400 throughout the treatment without documenting the reason why the BFR could not be maintained at the prescribed rate. c. On 1/30/25, treatment was initiated at a BFR of 450 and was decreased to a BFR of 400 two (2) hours and fifty-nine (59) minutes later for the remainder of the treatment without documenting the reason the BFR could not be maintained at the prescribed rate. d. On 2/6/25, treatment was initiated and maintained at a BFR of 400 throughout treatment without documenting the reason the BFR could not be maintained at the prescribed rate. e. On 2/15/25, treatment was initiated and maintained at a BFR of 400 throughout treatment without documenting the reason the BFR could not be maintained at the prescribed rate. 3. Patient #5 had diagnoses that included end stage renal disease. Review of the physician’s orders directed hemodialysis three (3) times weekly for three (3) hours and thirty (30) minutes with a left upper arteriovenous fistula (AVF), and a blood flow rate (BFR) of 400. A review of Patient #5’s treatment flowsheets identified the following: a. On 2/5/24 Patient #4’s treatment was initiated at 5:50 AM with a BFR of 400. At 7:01 AM the BFR was decreased to 350 with no rationale as to why the prescribed BFR of 400 was not met. b. On 2/7/24 Patient #4’s treatment was initiated at 5:58 AM with a BFR of 300 with no rationale as to why the prescribed BFR of 400 was not met. At 7:35 AM the BFR increased to 350 with no rationale as to why the prescribed BFR of 400 was not met. c. On 2/10/24 Patient #4’s treatment was initiated at 5:57 AM with a BFR of 400. At 7:04 AM the BFR decreased to 350 with no rationale as to why the prescribed BFR of 450 was not met. e. On 2/12/24 Patient #4’s treatment was initiated at 6:09 AM with a BFR of 400. At 7:37 AM the BFR decreased to 350 with no rationale as to why the prescribed BFR of 450 was not met. f. On 2/17/24 Patient #4’s treatment was initiated at 6:04 AM with a BFR of 400. At 8:31 AM the BFR was decreased to 350 with no rationale as to why the prescribed BFR of 450 was not met. Interview with the Clinical Coordinator on 2/26/25 at 2:55 PM identified that staff should be noting the reason the BFR is not attainable in the vitals comment line of the treatment record and notify the charge nurse so that he/she could inform the physician and receive a temporary order for a new BFR and/or have the access assessed if needed. Review of the Patient Assessment and Monitoring policy directed during treatment to check the machine settings, measurements, and that the prescribed blood flow rate (BFR) is being achieved or to document the reason in the medical record if unable to meet the prescribed BFR.”

“PA-ASSESS B/P, FLUID MANAGEMENT NEEDS CFR(s): 494.80(a)(2) The patient’s comprehensive assessment must include, but is not limited to, the following: Blood pressure, and fluid management needs. This Standard is not met as evidenced by: 47491 Based on a review of clinical records, interview, and policy review for one (1) out of four (4) hemodialysis patients (Patient #2) reviewed for prescription adherence, the facility failed to ensure the registered nurse was notified/patient was assessed for blood pressures that were out of range (less than 100 systolic, and greater than 100 diastolic). The findings included the following: 1. Patient #6 had diagnoses which included end stage renal disease. A physician’s orderdirected for hemodialysis treatment three (3) times weekly utilizing a central venous catheter in the upper chest for four (4) hours, a 2.0 potassium/2.5 calcium dialysate bath, blood flow rate (BFR) of 400, and an autoflow 1.5 dialysate flow rate (DFR). Review of Patient #6’s treatment records identified the following: a. On 2/3/25, an intradialytic blood pressure of 149/116 was obtained at 10:10 AM and failed to indicate staff had rechecked the blood pressure and/or that a registered nurse was notified of the elevated diastolic blood pressure reading. b. On 2/5/25, an intradialytic blood pressure of 95/73 was obtained at 9:31 AM and failed to indicted staff had rechecked the blood pressure and/or that a registered nurse was notified of the reduced systolic blood pressure reading. Interview with the Clinical Coordinator on 2/26/25 at 2:57 PM identified staff should be notifying the registered nurse and/or charge nurse of an abnormal blood pressure so that the patient could be assessed to determine if a further intervention is needed, with the physician making that determination. Review of the Patient Assessment and Monitoring policy directed staff to recheck blood pressures after a drop that required interventions and to report to the nurse systolic blood pressures less than 100 and diastolic blood pressures greater than 100.”

“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: 44675 Based on clinical record review, facility documentation, and interviews for one (1) of four (4) hemodialysis patients reviewed for adequacy, (Patient #3), the facility failed to ensure the patient’s hemodialysis treatment was in accordance with the physician orders. The findings include: Patient #3 had diagnoses that included end stage renal disease. Review of the physician’s orders directed hemodialysis three (3) times weekly for three (3) hours and thirty (30) minutes with a central venous catheter (CVC), a blood flow rate (BFR) of 400 and a dialysate flow rate (DFR) of 800. The annual care plan dated 1/7/25 identified that Patient #3’s adequacy (Kt/v) goal was greater than or equal to 1.4 with interventions that included to refer to the social worker for issues related to treatment adherence, educate the patient on adequacy principles and treatment adherence. Review of Patient #’3 Kt/v (a measurement of the efficacy of hemodialysis) on 1/16/25 was .79 (the acceptable range is greater than or equal to 1.2). A sample review of Patient #3’s treatment flowsheets identified on 1/16/25, 1/25/25 and 2/4/25 Patient #3’s treatment DFR was set to 600 with no rationale as to why the prescribed DFR of 800 was not met. Review of Patient #’3 Kt/v (a measurement of the efficacy of hemodialysis) on 2/6/25 was .62 (the acceptable range is greater than or equal to 1.2). A sample review of Patient #3’s treatment flowsheets identified on 2/6/25, 2/18/25, 2/20/25 and 2/22/25 Patient #3’s treatment DFR was set to 600 with no rationale as to why the prescribed DFR of 800 was not met. Interview with the Clinical Manager on 2/26/25 at 2:30 PM identified if a patient is not recieving the prescribed DFR, it needs to be documented in the medical record. Review of the patient assessment and monitoring policy directed during treatment to check the machine settings and measurements. It identified to check that the dialysate flow rate setting is correct, and the prescribed flow is being delivered. It further identified to document any findings and interventions in the medical record.”

“PQ-STAFF LIC AS REQ/QUAL/DEMO COMPETENCY CFR(s): 494.140 All dialysis facility staff must meet the applicable scope of practice board and licensure requirements in effect in the State in which they are employed. The dialysis facility’s staff (employee or contractor) must meet the personnel qualifications and demonstrated competencies necessary to serve collectively the comprehensive needs of the patients. The dialysis facility’s staff must have the ability to demonstrate and sustain the skills needed to perform the specific duties of their positions. This Standard is not met as evidenced by: 47491 Based on review of facility documents and interviews, the facility failed to ensure staff competencies were completed on an annual basis in accordance with facility policy. The findings included: Review of staff competencies identified the following: 1. Staff Person #7 last completed his/her annual competencies 8/7/23, one (1) year, six (6) months and nineteen (19) days ago. 2. Staff Person #1 last completed his/her annual competencies 10/12/22, two (2) years, four (4) months and fourteen (14) days ago. 3. The Clinical Coordinator last completed his/her annual competencies 9/5/23, one (1) year, five (5) months and twenty-one (21) days ago. Interview with the Clinical Coordinator on 2/26/25 at 2:56 PM identified facility practice is to complete competencies annually by the due date and was unable to state why Staff Person #7, #1, and the Clinical Coordinator were past their annual competencies due date. Interview with the Director of Operations on 2/26/25 at 3:00 PM identified all staff with past due annual competencies would have them completed by the following week or they would not be permitted to perform patient care. Review of the Knowledge, Skills, and Competency Evaluation for Clinical Staff policy directed employees were required to pass all exams as identified by Fresenius Kidney Care training and state requirements, were required to successfully complete all skills requirements, including all initial and annual skills validation, within the given timeframe, and that employees without current documented competency within the past 365 days may be removed from performing independent direct patient care until competency was demonstrated and documented.”

“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: 47491 Based on observations, facility documentation, facility policy and interviews the facility failed to ensure a patient (Patient #9) receiving hemodialysis treatment always had their hemodialysis access visible at all times during hemodialysis treatment. The findings included: Patient # 9 had diagnoses that included end stage renal disease, a left upper arm arteriovenous fistula (AVF), a physician’s order for hemodialysis three (3) times weekly for four (4) hours per treatment, utilizing a 2.0 potassium/ 2.5 calcium dialysate bath, at a blood flow rate of 450, and dialysate flow rate of 800. Observation of Patient #9 while receiving treatment on 2/24/25 identified the following: a. At 9:48 AM, surveyor identified Patient #9’s AVF (left upper arm) was covered completely by a blanket. b. At 9:49 AM, surveyor observed Staff Person #5 attending to Patient #9’s dialysis machine alarm without uncovering the patient’s covered access. c. At 9:50 AM, surveyor observed Staff Person #5 entering Patient #9’s dialysis station to replace the bicarbonate bag and failed to uncover the patient’s covered access. d. At 9:51 AM, surveyor observed Staff Person #5 entering Patient #9’s dialysis station to address a machine alarm and resetting the machine, however failed to uncover the covered access. e. At 9:53 AM, surveyor observed Staff Person #6 entering Patient #9’s dialysis station to address a machine alarm, reset the machine, speaking with the patient while entering data into the electronic medical record, and leaving the dialysis station at 9:55 AM without addressing the covered access. Interview with Staff Person #5 on 2/24/25 at 10:00 AM identified he/she failed to check the patient’s access upon entering his/her dialysis station and that the access should always be visible to ensure patient safety and prevent blood loss as the patient could exsanguinate (excessive bleeding). Staff Person #5 further identified staff should check the patient’s access each time their dialysis station is entered to ensure the access was visible. Interview with Staff Person #6 on 2/24/25 at 9:56 AM identified Patient #8’s access site was still covered as Staff Person #6 had to uncover the site to identify the location of the patient’s vascular access. Staff Person #6 identified he/she was unable to see the access site as it was covered by the patient’s blanket. Staff Person #6 further identified the access should always remain visible as the needle could dislodge, and the patient could exsanguinate without staff knowledge. Interview with the Medical Director on 2/24/25 at 3:26 PM identified a hemodialysis access should always be visible throughout a patient’s treatment to prevent the patient from exsanguination. Interview with the Clinical Coordinator on 2/25/25 at 8:39 AM identified staff was to ensure a patient’s access remained visible throughout their dialysis treatment, when performing thirty (30) minute vital checks, when checking on a patient’s status, and anytime a patient’s dialysis station was entered. Review of the Patient Assessment and Monitoring policy directed staff to ensure the access remains uncovered throughout the patient’s treatment.”