Fmc Medford Dialysis Center (Bma Medford)

“CFC-INFECTION CONTROL CFR(s): 494.30 This Condition is not met as evidenced by: 10249 Based on observations, record review, staff interviews, and policy reviews, the facility failed to ensure that 7 of 10 facility staff observed (Charge Nurse [CN] #1, Registered Nurse [RN] #6, Certified Clinical Hemodialysis Technician [CCHT] #1, CCHT #5, CCHT #7, and Patient Care Technician [PCT] #1, and PCT #5) implemented adequate infection control measures to ensure the health and safety of all patients. Findings include: 1. The facility failed to ensure a sanitary environment to minimize the transmission of infectious agents within the treatment area. Refer to V111 2. The facility failed to ensure that 1 staff member (CCHT #7) removed their face shield and mask, prior to exiting the isolation room, after caring for a patient known to be hepatitis B positive (HBsAg positive). Refer to V115 3. The facility failed to ensure the separation of clean and dirty items related to the storage of personal protective equipment (PPE), increasing the risk of cross contamination. Refer to V117 4. The facility failed to 1.) ensure that 2 of 3 staff observed (PCT #1, and PCT #5), adequately cleaned and disinfected contaminated surfaces, medical devices and equipment within the dialysis station, on the treatment floor and in the isolation room, therefore increasing the risk for cross contamination of blood borne pathogens; 2.) ensure that 20 of 24 hemodialysis chair tray tables were free of tape residue to allow for proper disinfection; 3.) ensure that 7 of 24 blood pressure (BP) cuffs were free from lint and debris, to allow for proper disinfection and reduce the risk of spread of infection; and 4.) ensure bleach was stored in an opaque, covered container to prevent disintegration of the chemical when exposed to sunlight and air. Refer to V122 5. The facility failed to provide evidence that the isolation room had dedicated equipment for use only with patients who are positive for Hepatitis B. Refer to V130 6. The facility failed to ensure that 1 of 2 staff members observed (CCHT #5) performed adequate infection control practices regarding fistula cannulation for 1 of 2 patients (#11) with fistulas/grafts, out of a total sample of 12 patients. Refer to V142 7. The facility failed to ensure 1 of 2 staff observed (CCHT #1) adhered to appropriate infection control practices to prevent intravascular infection, while performing a Central Venous Catheter (CVC) exit site dressing change. Refer to V147”

“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: 37349 Based on observation, interview, and review of Centers for Disease Control and Prevention guidance CDC, the facility failed to ensure a sanitary environment to minimize the transmission of infectious agents within the treatment area. Findings Include: The Centers for Disease Control and Prevention (CDC) defines a “sanitary environment” as an environment that meets the “Standard Precautions” for an inpatient hospital setting plus the more stringent precautions which are recommended for hemodialysis units because of the increased potential for contamination with blood and pathogenic microorganisms. On 3/19/23 at 9:00 A.M., during the flash tour of the dialysis treatment area, the surveyor observed the laminate on the counter was missing, exposing the plywood. The missing laminate was locate at stations #1, 2, 3, and 4. This would make attempts to disinfect ineffective and create the risk of spreading infection. During an interview on 3/20/24 at 1:45 P.M., the Facility Administrator said she was not sure if the countertops, behind stations 1, 2, 3, and 4, could be properly disinfected due to the missing laminate.”

“IC-GOWNS, SHIELDS/MASKS-NO STAFF EAT/DRINK CFR(s): 494.30(a)(1)(i) Staff members should wear gowns, face shields, eye wear, or masks to protect themselves and prevent soiling of clothing when performing procedures during which spurting or spattering of blood might occur (e.g., during initiation and termination of dialysis, cleaning of dialyzers, and centrifugation of blood). Staff members should not eat, drink, or smoke in the dialysis treatment area or in the laboratory. This Standard is not met as evidenced by: 31240 Based on observation, staff interview, policy review, and Centers for Disease Control and Prevention (CDC) guidance for Isolation Precautions, the facility failed to ensure 1 staff member (Certified Clinical Hemodialysis Technician [CCHT] #7) removed their face shield and mask, prior to exiting the isolation room, after caring for a patient known to be hepatitis B positive (HBsAg positive). Findings include: Review of the facility’s policy entitled, Dialyzing Patients with Positive Hepatitis B (infection of the liver caused by a virus) Antigen (HBsAg+), dated 11/6/23, indicated the following: *Caring for HBsAg positive patients requires adherence to strict guidelines. The Hepatitis B virus is highly infectious because the concentration of the virus particles in the blood is very high and the Hepatitis B virus can live outside the body on surfaces for at least 7 days. Outbreaks of Hepatitis B have been linked directly to poor infection control practices. Outbreaks tend to occur in patients who are antibody negative and who have not been vaccinated for Hepatitis B. *All patients who are HBsAg positive must dialyze under isolation precautions. *PPE must be removed and discarded or left in the isolation room/area if not soiled. Review of the Centers for Disease Control and Prevention (CDC) Guideline for Isolation Precautions: Preventing Transmission of Infectious Agents in Healthcare Settings (2007), indicated the following: *Wear PPE when the nature of the anticipated patient interaction indicates that contact with blood or body fluids may occur. *Before leaving the patient’s room or cubicle, remove and discard PPE. Review of the daily staff/patient assignment sheet, dated 3/19/24, indicated the patient receiving his/her dialysis in the isolation room between 8:00 A.M. and 12:00 P.M., was Hepatitis B positive. During an observation on 3/19/24 at 11:18 A.M., the surveyor observed CCHT #7 enter the isolation room wearing a face shield and mask. She donned a gown and gloves, then adjusted the hemodialysis machine that was alarming. She then removed her gown, hung it up, doffed her gloves, and applied hand gel before exiting the room. She was observed exiting the isolation room wearing her face mask and shield, and then proceeded to care for another patient being dialyzed. During an interview on 3/19/24 at 11:20 A.M., CCHT #7 said she did not remove her shield before exiting the isolation room because she did not have another shield to wear. She said she should have removed both her shield and mask before exiting the isolation room.”

“IC-CLEAN/DIRTY;MED PREP AREA;NO COMMON CARTS CFR(s): 494.30(a)(1)(i) Clean areas should be clearly designated for the preparation, handling and storage of medications and unused supplies and equipment. Clean areas should be clearly separated from contaminated areas where used supplies and equipment are handled. Do not handle and store medications or clean supplies in the same or an adjacent area to that where used equipment or blood samples are handled. When multiple dose medication vials are used (including vials containing diluents), prepare individual patient doses in a clean (centralized) area away from dialysis stations and deliver separately to each patient. Do not carry multiple dose medication vials from station to station. Do not use common medication carts to deliver medications to patients. If trays are used to deliver medications to individual patients, they must be cleaned between patients. This Standard is not met as evidenced by: 31240 The facility failed to ensure the separation of clean and dirty items related to the storage of personal protective equipment (PPE), increasing the risk of cross contamination for 3 of 3 staff members observed (Registered Nurse [RN] #6, Patient Care Technician (PCT) #1 and Charge Nurse (CN) #1. Findings include: Review of the facility’s policy entitled, Dialyzing Patients with Positive Hepatitis B (infection of the liver caused by a virus) Antigen (HBsAg+), dated 11/6/23, indicated the following: *Caring for HBsAg positive patients requires adherence to strict guidelines. The Hepatitis B virus is highly infectious because the concentration of the virus particles in the blood is very high and the Hepatitis B virus can live outside the body on surfaces for at least 7 days. Outbreaks of Hepatitis B have been linked directly to poor infection control practices. Outbreaks tend to occur in patients who are antibody negative and who have not vaccinated for Hepatitis B. *Hand hygiene must be practiced when entering and leaving the isolation room. On 3/19/24 between 10:50 A.M. and 11:32 A.M., the surveyor observed RN #6, PCT #1 and CN #1, exiting the isolation room after caring for a hepatitis B positive patient and/or adjusting the dialysis machine. All three staff members were observed going to a hand sink outside of the isolation room and washing their hands. The surveyor observed 2 boxes of surgical masks (one on top of another) stored on a countertop, directly to the right of the sink, and below the paper towel dispenser. The top box was wet with fluid splashes and the bottom box was wet and damp on the bottom. All three staff (RN #6, PCT #1 and CN #1) then donned a clean surgical mask from a wet box of surgical masks located on the counter of the hand sink. During an interview on 3/20/24 at 1:45 P.M., the Facility Administrator said the clean surgical mask boxes should not have been stored at the side of the sink where staff were washing their hands directly after exiting the isolation room. She said the masks would need to be stored elsewhere to prevent cross contamination of them.”

“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: 31240 Based on observation, staff interview, and policy review, the facility failed to 1.) ensure that 2 of 3 staff observed (Patient Care Technician [PCT] #1, and PCT #5), adequately cleaned and disinfected contaminated surfaces, medical devices, and equipment within the dialysis station, on the treatment floor and in the isolation room, therefore increasing the risk for cross contamination of blood borne pathogens; 2.) ensure that 20 of 24 hemodialysis chair tray tables were free of tape residue to allow for proper disinfection; 3.) ensure that 7 of 24 blood pressure (BP) cuffs were free from lint and debris, to allow for proper disinfection, and reduce the risk of spread of infection; and 4.) ensure bleach was stored in an opaque, covered container to prevent disintegration of the chemical when exposed to sunlight and air. Findings include: 1. The facility failed to ensure that 2 of 3 staff observed (PCT #1, and PCT#5) adequately cleaned and disinfected the dialysis station between patients. Review of the facility’s policy entitled, Cleaning and Disinfecting the Dialysis Station, dated 9/5/23, indicated the following: *Equipment in the dialysis station may include (but not limited to) the following: dialysis machine/cycler and attachments such as intravenous (IV) poles, BP cuff and hand sanitizer holder/organizer. *The dialysis station could become contaminated with blood and other body fluids during treatment. After use, any non-disposable equipment and supplies brought into the dialysis station must be disinfected with 1:100 bleach or Environmental Protection Agency (EPA) registered disinfectant before removed from the dialysis station. *All work surfaces shall be cleaned and disinfected with 1:100 bleach solution after completion of procedures. Make the surface glistening wet and let air dry unless otherwise specified by the manufacturer. *Clean and disinfect any surfaces contaminated with blood or other potentially infectious material immediately or as soon as feasible. a. The facility failed to ensure PCT #1 adequately cleaned and disinfected contaminated surfaces within the isolation dialysis room, between patients, increasing the risk for cross contamination of blood borne pathogens. Review of the facility’s policy entitled, Dialyzing Patients with Positive Hepatitis B (infection of the liver caused by a virus) Antigen (HBsAg+), dated 11/6/23, indicated the following: *Caring for HBsAg positive patients requires adherence to strict guidelines. The Hepatitis B virus is highly infectious because the concentration of the virus particles in the blood is very high and the Hepatitis B virus can live outside the body on surfaces for at least 7 days. Outbreaks of Hepatitis B have been linked directly to poor infection control practices. Outbreaks tend to occur in patients who are antibody negative and who have not vaccinated for Hepatitis B. Review of the daily staff/patient assignment sheet, dated 3/19/24, indicated the patient receiving his/her dialysis in the isolation room, between 8:00 A.M. and 12:00 P.M., was Hepatitis B positive. During an observation on 3/19/24 at 1:05 P.M., the surveyor observed PCT #1 clean and disinfect the station in the isolation room, following the dialysis treatment for a Hepatitis B patient. PCT #1 failed to: *Clean and disinfect the back and right side of the dialysis machine, including the sharps the container attached to the right side of the machine. *Clean and disinfect the surfaces around the clean sink, where she had placed her face shield, while washing her hands. *Clean and disinfect a wheeled cart and cabinet, both of which had supplies stored on them. *Clean and disinfect the area around the dirty sink. *Clean and disinfect the floor underneath the supply cart. *Clean and disinfect the walls and cabinets beside, and behind, the treatment chair. During an interview on 3/19/24 at 1:25 P.M., PCT #1 said that she missed disinfecting those areas, and they all should have been cleaned and disinfected. During an interview on 3/20/24 at 1:00 P.M., the Facility Administrator said all surfaces and equipment in the isolation room should have been disinfected, per the facility policy, to reduce the risk of spreading infection to other staff and patients. 38141 b. The facility failed to ensure PCT #5 adequately cleaned and disinfected contaminated surfaces within the dialysis station between patients, increasing the risk for cross contamination of blood borne pathogens. On 3/19/24 at 10:40 A.M., during observation of the treatment area, the surveyor observed PCT #5 disinfecting the dialysis machine at station 7 for the next patient. She was observed disinfecting the dialysis machine using the 1:100 bleach-soaked pads. PCT #5 failed to disinfect the arms of the intravenous (IV) pole, and the stethoscope that was hanging on the arms of the IV pole. PCT #5 was then observed disinfecting the blood pressure cuff, then placed it on the arms of the dirty IV pole that had not been disinfected. PCT #5 also failed to clean/disinfect the countertops behind the dialysis chair and dialysis machine. During an interview on 3/19/24 at 10:50 A.M., PCT #5 said that she did not realize that she missed areas identified by the surveyor. PCT #5 said that those areas should be cleaned during the disinfection process. 37349 2. The facility failed to ensure the hemodialysis chair tray tables were free of tape debris to allow for proper disinfection, and reduce the risk of spread of infection. On 3/19/24 at 9:00 A.M., during observation of the treatment area, the surveyor observed paper tape debris on 20 of 24 hemodialysis chair tray tables located at stations # 1, 2, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, and 23. During an interview on 3/19/24 at 10:50 A.M., Certified Clinical Hemodialysis Technician (CCHT) # 5 said the tape needs to be removed to be able to properly disinfect the dialysis chair tray tables. During an interview on 3/20/24 at 1:45 P.M., the Facility Administrator said that once a week the tables are scrubbed clean of tape residue, and there should not be tape residue on the dialysis chair side tables. 3. The facility failed to ensure 7 of 24 blood pressure cuffs were not laden with lint to allow for proper disinfection to reduce the risk of spread of infection. On 3/19/24 at 9:00 A.M., during observation of the treatment area, the surveyor observed 7 of 24 blood pressure cuffs laden with lint at station # 3, 6, 9, 10, 19, 21, and the isolation room. During an interview on 3/21/24 at 1:45 P.M., the Facility Administrator said that blood pressure cuffs should be replaced when they become laden with lint, so they can be properly disinfected. 4. The facility failed to ensure bleach was stored in an opaque, covered container to prevent disintegration of the chemical when exposed to sunlight and air. Review of the facility’s policy entitled, Cleaning and Disinfecting the Dialysis Station, published 9/5/23, included the following: * Bleach solution will be stored in labeled, covered, opaque containers to prevent disintegration of the chemical when exposed to sunlight and air. On 3/19/24 from 11:00 A.M. to 12:00 P.M., the surveyor observed the container of 1:100 bleach solution stored in a clear plastic container, located across from station #1, left uncovered. During an interview on 3/20/24 at 1:45 P.M., the Facility Administrator said bleach should be stored in an opaque container, and covered when not in use.”

“IC-HBV-ISOLATION-MACHINES/EQUIP/SUPPLIES CFR(s): 494.30(a)(1)(i) Isolation of HBV+ Patients To isolate HBsAg positive patients, ... dedicate machines, equipment, instruments, supplies, and medications that will not be used by HBV susceptible patients. This Standard is not met as evidenced by: 31240 Based on observation, interview, and policy review, the facility failed to provide evidence that the isolation room had dedicated equipment only for patients who are positive for hepatitis B. Findings include: Review of the facility’s policy entitled, Dialyzing Patients with Positive Hepatitis B (infection of the liver caused by a virus) Antigen (HBsAg+), dated 11/6/23, indicated the following: *Caring for HBsAg positive patients requires adherence to strict guidelines. The Hepatitis B virus is highly infectious because the concentration of the virus particles in the blood is very high and the Hepatitis B virus can live outside the body on surfaces for at least 7 days. Outbreaks of Hepatitis B have been linked directly to poor infection control practices. Outbreaks tend to occur in patients who are antibody negative and who have not vaccinated for Hepatitis B. *Separated dedicated supplies and equipment, including blood glucose monitors, must be used to provide care to the Hepatitis B positive patient. *All supplies used in the isolation room/area such as clamps, blood pressure cuffs, testing reagents, etc., should be labeled “isolation” and not routinely removed. Patient #1 was admitted to the facility in February 2024 with a diagnosis of End Stage Renal Disease and Hepatitis B virus. On 3/19/24 from 10:50 A.M. to 11:30 A.M., the surveyor observed Patient #1 receiving his/her dialysis treatment in the isolation room. On 3/19/24 at 1:00 P.M., the surveyor and the Facility Administrator (FA) observed the following items that were not labeled for isolation room use only: *Centrifuge (machine used to spin a sample of blood). *Oxygen concentrator. *Dialysis chair. During an interview at 3/19/24 at 1:05 P.M., the FA said the equipment should have been labeled with an isolation label.”

“IC-O-SIGHT-MONITOR ACTIVITY/IMPLEMENT P&P CFR(s): 494.30(b)(1) The facility must- (1) Monitor and implement biohazard and infection control policies and activities within the dialysis unit; This Standard is not met as evidenced by: 37349 Based on observation, interview, and policy review, 1 of 2 staff (Certified Clinical Hemodialysis Technician [CCHT] #5) observed, failed to ensure adequate infection control practices regarding fistula cannulation for 1 of 2 patients (#11) observed with fistulas/grafts, out of a total sample of 12 patients. Findings include: Review of the facility’s policy entitled, Access Assessment and Cannulation, published 7/5/22, included the following: *Disinfect cannulation site as follows: 70 % isopropyl alcohol pad: Using gentle friction, clean the access site beginning in the center and continuing outward 2 inches in a concentric circle for 30 seconds and allow to dry before cannulating. For Patient #11, CCHT #5 failed to ensure adequate disinfection to both the upper and lower needle access sites of the fistula, in accordance with facility policy. On 3/19/24 at 11:45 A.M., the surveyor observed CCHT #5 as he prepared to cannulate Patient #11’s fistula access for dialysis. CCHT #5 opened an alcohol pad and using gentle friction, cleaned the lower access site beginning in the center and continuing outward 2 inches in a concentric circle for 10 seconds, not 30 seconds per the policy. He allowed the alcohol to dry and cannulated the lower access site. CCHT #5 then opened another alcohol pad and using gentle friction, cleaned the upper access site beginning in the center and continuing outward 2 inches in a concentric circle for 15 seconds, not 30 seconds per policy. He allowed the alcohol to dry and cannulated the upper access site. During an interview on 3/19/24 at 12:00 P.M., CCHT #5 said the policy was to disinfect each cannulation site for 30 seconds. He said he counted in his head, and did not realize he had not disinfected long enough.”

“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: 38141 Based on observation, interview, and policy review, the facility failed to ensure 1 of 2 staff (Certified Clinical Hemodialysis Technician (CCHT) #1) observed adhered to appropriate infection control practices to prevent intravascular infection, while performing a Central Venous Catheter (CVC) exit site dressing change, for 1 of 2 applicable patients (#12), from a total sample of 12 patients. Findings include: Review of the facility policy entitled, Changing the Catheter Dressing Procedure, dated 5/2/22, indicated the following: *Perform hand hygiene. *Remove swab stick from package by stick end without touching foam applicator. Handle only the stick portion. *2% Chlorhexidine and 70% alcohol: using gentle back and forth friction, clean the exit site beginning in the center and continuing outward 2 inches in a concentric circle for 30 seconds and allow to dry a minimum of 30 seconds. For Patient #12, CCHT #1 failed to ensure adequate disinfection during exit site care, according to facility policy. During an observation on 3/19/24 at 11:15 A.M., the surveyor observed CCHT #1 as she prepared Patient #12 for initiation of his/her dialysis treatment. CCHT #1 obtained supplies which included a swab stick and sterile bordered dressing. CCHT #1 placed a clean barrier under the patient’s CVC limbs and removed the old dressing, which she discarded in the trash. The surveyor observed CCHT #1 cleansing the CVC area with the Chlorhexidine/alcohol swab stick. CCHT #1 started to clean above the exit site moving the swab outward, using gentle back and forth motion for 30 seconds. CCHT #1 failed to clean below the exit site. During an interview on 3/19/24 at 12:15 P.M., CCHT #1 said she thought she cleaned the whole area. She said she didn’t realize that she missed the area under the exit site.”

“PA-FREQUENCY REASSESSMENT-UNSTABLE Q MO CFR(s): 494.80(d)(2) In accordance with the standards specified in paragraphs (a)(1) through (a)(13) of this section, a comprehensive reassessment of each patient and a revision of the plan of care must be conducted- At least monthly for unstable patients including, but not limited to, patients with the following: (i) Extended or frequent hospitalizations; (ii) Marked deterioration in health status; (iii) Significant change in psychosocial needs; or (iv) Concurrent poor nutritional status, unmanaged anemia and inadequate dialysis. This Standard is not met as evidenced by: 10249 Based on record review, interview, and policy review, the facility failed to ensure an unstable comprehensive reassessment and revision of the plan of care was conducted for 1 of 10 applicable patients (#5), out of a total sample of 12 patients, after Patient #5 had an extended hospitalization stay of greater than 15 days. Findings include: Review of the facility policy entitled, Comprehensive Interdisciplinary Assessment and Plan of Care, published 7/3/23, indicated the following, but not limited to: *Unstable patients must be reassessed by the IDT (interdisciplinary team). Monthly reassessment and any POC (plan of care) updates related to the reason the patient is considered “unstable” must be documented until the issues have been resolved, or the IDT (including the patient if possible) determines that the condition is chronic. * The following are unstable criteria: Extended or frequent hospitalizations: a.) Hospitalization of more than 15 days with discharge occurring within the last 30 days, or b.) More than 3 admissions in the last 30 days, or marked deterioration in health status. Patient #5 was admitted to the facility in April 2021 with a diagnosis of End Stage Renal Disease, requiring dialysis. Review of the clinical record indicated that Patient #5 had a comprehensive assessment completed in 8/22/23, with a plan of care developed based on that assessment. Further review of the clinical record indicated that Patient #5 had been hospitalized from 1/9/24 to 1/26/24, for a total of 17 days, for acute/chronic respiratory failure with hypoxia (lack of oxygen). During an interview on 3/20/24 at 10:00 A.M., the Facility Administrator said it got missed and an unstable assessment and care plan should have been completed when Patient #5 returned from the hospital.”

“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: 38141 Based on record review and interview, the facility failed to ensure that the dialysis treatment order was delivered as prescribed, relative to Blood Flow Rate (BFR-speed (measured in milliliters per minute [ml/min]) in which the patient’s blood pushed through the dialyzer and back into the body) and Dialysis Flow Rate (DFR-the measurement of how fast the dialysate solution flows in ml/min) to draw toxins from the patient’s blood during the process of dialysis, for 1 of 9 applicable patients (#4), out of a sample of 12 patients. Findings include: For Patient #4, admitted to the facility in April 2017 with diagnoses which included End Stage Renal Disease (ESRD), the dialysis staff failed to ensure that the BFR and/or DFR were delivered as prescribed. Review of the Physician’s order, dated 2/15/24, indicated the BFR was to be delivered at a rate of 400 ml/min, and DFR was to be delivered at the rate of 800 ml/min. Review of an updated Physician’s order, dated 3/7/24, indicated the BFR was to be delivered at a rate of 250 ml/min, and DFR was to be delivered at the rate of 400 ml/min. Review of the 9 Hemodialysis Flowsheets, dated from 2/29/24 through 3/19/24, indicated that the BFR and DFR had not been delivered as prescribed for 4 of 9 Hemodialysis Flowsheets as follows: *3/2/24 - the BFR was delivered at a rate of 350 ml/min, not 400 ml/min as ordered, and there was no documentation to indicate why the physician’s order was not followed. *3/5/24 - the BFR was delivered at a rate of 250 ml/min, not 400 ml/min, and DFR was delivered at a rate of 400 ml/min, not 800 ml/min as ordered, and there was no documentation to indicate why the physician’s order was not followed. *3/14/24 - the DFR was delivered at a rate of 800 ml/min, not 400 ml/min as ordered, and there was no documentation to indicate why the physician’s order was not followed. *3/16/24 - the DFR was delivered at a rate of 800 ml/min, not 400 ml/min as ordered, and there was no documentation to indicate why the physician’s order was not followed. During an interview on 3/21/24 at 9:45 A.M., the Facility Administrator said that if the staff cannot deliver the rate as ordered, the nurse should document on the flowsheet the reason why the BFR or DFR were not delivered at the ordered rate.”

“POC-COMPLETED/SIGNED BY IDT & PT CFR(s): 494.90(b)(1) The patient’s plan of care must- (i) Be completed by the interdisciplinary team, including the patient if the patient desires; and (ii) Be signed by the team members, including the patient or the patient’s designee; or, if the patient chooses not to sign the plan of care, this choice must be documented on the plan of care, along with the reason the signature was not provided. This Standard is not met as evidenced by: 31240 Based on record review, interview and policy review, the facility failed to 1.) ensure the care plan was signed by the patient, or the patient’s designees; or if the patient chooses not to sign the plan of care, this choice must be documented on the plan of care, along with the reason the signature was not provided, to ensure patient involvement with his/her plan of care; and 2.) ensure the physician signed the care plan, as part of the interdisciplinary team, for 1 of 10 applicable patients (#6), from a total sample of 12 patients. Findings include: Review of the facility’s policy entitled, Comprehensive Interdisciplinary Assessment (CIA) and Plan of Care, dated 7/3/23, indicated the following: *The CIA and plan of care must be developed and implemented by an interdisciplinary team (IDT) consisting of at a minimum, the patient or patient’s designee, a registered nurse, the patient’s attending physician (or physician extender where allowed by state regulations), qualified master’s degree level social worker and qualified registered dietitian. *The plan of care should be signed at the time of the IDT meeting for those in attendance. For Patient #6, the facility failed to ensure the plan of care was signed by the patient during the IDT meeting, and the patient’s physician. Patient #6 was admitted to the facility in December 2021 with a diagnosis of End Stage Renal Dialysis, requiring hemodialysis. The Patient was receiving home hemodialysis at home. Review of the progress note in the clinical record, dated 1/26/24 indicated the patient was in the clinic for a monthly visit with the IDT, and the same day, the patient’s care plan meeting was being held. Review of signature page of the care plan indicated it was not signed by the physician, nor the patient/patient designee. During an interview on 3/20/24 at 10:00 A.M., the Regional Home Therapy Nurse said the care plan was not printed on the day of the IDT meeting with the patient and caregiver, and was not signed by either. She said the physician did not sign it until 1/27/24, the day after the IDT meeting. She said the care plan would need to be signed by the patient/patient designee when he/she came in for the next clinic appointment.”

“QAPI-MONITOR/ACT/TRACK/SUSTAIN IMPROVE CFR(s): 494.110(b) The dialysis facility must continuously monitor its performance, take actions that result in performance improvements, and track performance to ensure that improvements are sustained over time. This Standard is not met as evidenced by: 10249 Based on Quality Assessment Performance Improvement (QAPI) minutes review, Clinic Audit Checklist review, staff interview, and policy review, the facility failed, despite conducting monthly audits, to sustain an effective performance improvement program in regard to the facility’s infection control program and procedures. Findings include: Review of the facility policy entitled, Quality Assessment and Performance Improvement Program, published 5/2/22, included the following: * The QAPI Committee will monitor data/information; prioritize areas for improvement; determine potential root causes; develop, implement, evaluate, and revise action plans that result in sustainable improvements in patient care. * Elements to be reviewed will include: Infection Surveillance. * An effective and successful review of the QAPI meeting and program activities will include: review of the results of required self-audits. Review of 6 months of infection control clinic audits, dated August 24, 2023, through February 2024, indicated that 1 time per month the facility audited patient care provided related to exit site care, initiation and termination of central venous catheter, cleaning and disinfection of the dialysis station, and isolation practices. For 6 of 6 months, audits reflected that staff followed the facility policy with 90-100% accuracy. During this survey, the surveyors observed the following breaches in infection control: *Certified Clinical Hemodialysis Technician (CCHT) #7 failed to remove contaminated face shield and mask when leaving the isolation room, while caring for a patient who was infected with Hepatitis B, and before caring for another patient. *Registered Nurse #6, Patient Care Technician #1, and Charge Nurse #1 utilized PPE (face masks) that were stored on the clean hand sink, and had been exposed to water. *Personal Care Technician [PCT] #5 failed to adequately disinfect the station for the next patient, and PCT #1 failed to adequately clean and disinfect the isolation room after a patient with Hepatitis B virus was treated. *Facility staff failed to ensure the isolation room had dedicated equipment. *CCHT #5 failed to adequately disinfect the upper and lower needle access sites of an arteriovenous fistula (AVF) prior to treatment initiation. *CCHT #1 failed to adequately disinfect the area around a Central Venous Catheter during exit site care. During an interview on 3/21/24 at 10:00 A.M., the Facility Administrator said she does the monthly infection control audits, and the company policy only requires observation of 1 staff member each month, for each area, and observations have been good. The facility Administrator said giving the results of the surveyor observations, we need to increase our observations of staff on the treatment floor.”

“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: 31240 Based on record review, staff interview and policy review, the Medical Director failed to ensure that 1.) home therapy staff monitored and assured that 1 of 1 applicable home dialysis Patients (#6), administered and documented a bolus dose of heparin (blood thinning medication), and 2.) staff followed the facility policy related to reversing the orientation of the bloodlines to the central venous catheter (CVC) hub connections for 1 of 4 patients (#3) observed with a CVC, out of a total sample of 12 patients.. Findings include: 1. Patient #6 was admitted to the facility in December 2021 with a diagnosis of End Stage Renal Dialysis requiring hemodialysis via an Arteriovenous (AVF) Graft, which was being completed at home. Review of the facility’s policy entitled, Heparin Bolus Administration, dated 11/1/21, indicated the following: *The home therapies staff, hemodialysis patients and/or care partner will administer heparin as ordered by the physician. *Administer heparin only after both access needles have been placed and patency verified. Allow heparin to circulate within the blood stream for a minimum of 3-5 minutes before initiating treatment to prevent blood from clotting in the dialysis circuit. *Document the time and amount of heparin administered on the Home Treatment Record. Review of a physician’s order, dated 2/5/24, indicated Heparin Bolus 2000 units intravenous push (IVP) to be administered every treatment. Review of 9 Treatment Flowsheets, dated 3/4/24 through 3/19/24, indicated the following: *No time or administration of the heparin bolus was documented on 9 of 9 Treatment Flowsheets, including 3/4/24, 3/7/24, 3/9/24, 3/10/24, 3/13/24, 3/14/24, 3/15/24, 3/17/24, and 3/19/24. During an interview on 3/20/24 at 11:30 A.M., the Regional Home Therapy Nurse said Patient #6 had not documented if, and/or when the heparin bolus had been administered. She said the patient would need to be re-educated on documentation of the heparin administration in their electronic medical record for each day of dialysis. 37349 2. The Medical Director failed to ensure that staff followed the facility policy related to reversing the orientation of the bloodlines to the central venous catheter (CVC) hub connections for patients #3. Review of the facility policy entitled, Reversal of Central Venous Catheter Lines, published 2/5/24, included the following: * Reversing the orientation of the bloodlines to the catheter hub connections may be necessary to achieve prescribed blood flow. * Reversal of CVC lines requires the following documentation in the patient’s medical record * Provider order with frequency (each shift, x 1, etc.) entered in the patient medical record. * Reason for line reversal. * Action of line reversal in the treatment record. On 3/19/24 at 11:05 A.M., the surveyor observed Registered Nurse (RN) #3 discontinue the dialysis treatment for Patient #3. The dialysis bloodlines had been reversed. During an interview on 3/19/24 at 11:10 A.M., Patient #3 said that his/her lines need to be reversed or the machine will alarm. He/She said this has been for the past few months. During an interview on 3/19/24 at 11:10 A.M., RN #3 said that Patient #3 requires his/her bloodlines to be reversed or the machine will alarm. She said for the past few months they have been starting Patient #3’s dialysis treatment with the lines reversed, they do not try to start the treatment with lines in normal orientation because they know the machine will alarm. Review of a clinical note, dated 1/20/24, indicated that Patient’s lines had to be reversed during treatment today because the machine was constantly alarming for high arterial pressure. Treatment resumed without any issues after the lines were reversed. Doctor notified. Review of Patient #3’s physician orders failed to include a provider order for reversal of the bloodlines. Review of 9 of 9 treatment flowsheets, from 2/29/24 to 3/19/24, failed to indicate that the blood lines had been reversed, including: 2/29/24, 3/2/24, 3/5/24, 3/7/24, 3/9/24, 3/12/24, 3/14/24, 3/16/24, and 3/19/24. During an interview on 3/20/24 at 9:40 A.M., the Director of Operations said that there should be an order to reverse bloodlines and it should be documented on the treatment flowsheets.”

“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: 31240 Based on record review and interview, the facility failed to ensure the dialysis Treatment Flowsheets for 1 Patient (#6), receiving hemodialysis at home, were complete and accurate relative to 1.) documented estimated dry weight (EDW), and 2.) documentation of pre-dialysis weights for 4 of 9 treatment sheets. Findings include: Patient #6 was admitted to the facility in December 2021 with a diagnosis of End Stage Renal Dialysis requiring hemodialysis via an Arteriovenous (AVF) Graft, which was being completed at home. 1. Review of a Physician’s order, dated 12/14/22, indicated EDW 58.5 kilograms (kg). Review of 9 Treatment Flowsheets, dated 3/4/24 through 3/19/24, indicated the documented EDW was 58.0 kg, not 58.5 kg as ordered, on 9 of 9 Flowsheets including 3/4/24, 3/7/24, 3/9/24, 3/10/24, 3/13/24, 3/14/24, 3/15/24, 3/17/24, and 3/19/24. During an interview on 3/20/24 at 10:25 A.M., the Regional Home Therapy Nurse said Patient #6’s Flowsheets had an incorrect EDW documented on them, and it would need to be updated to the physician’s ordered EDW. 2. Review of 9 Treatment Flowsheets, dated 3/4/24 through 3/19/24, indicated that on 4 of 9 Flowsheets there were no documented pre-treatment weight, including 3/13/24, 3/14/24, 3/17/24, and 3/19/24. During an interview on 3/20/24 at 10:25 A.M., the Regional Home Therapy Nurse said Patient #6 had not documented the pre-treatment weight on those 4 Flowsheets and would need to be re-educated to maintain complete documentation on his/her Flowsheets.”