Usrc Quincy

“POC-VA MONITOR/PREVENT FAILURE/STENOSIS CFR(s): 494.90(a)(5) The patient’s vascular access must be monitored to prevent access failure, including monitoring of arteriovenous grafts and fistulae for symptoms of stenosis. This Standard is not met as evidenced by: 44223 Based on observation, policy review, and staff interview, the facility failed to ensure that 1 of 3 staff members (Certified Clinical Hemodialysis Technician [CCHT] #4) observed, evaluated a vascular access to ensure functionality by listening for the bruit the length of the access(swooshing sound heard with the stethoscope placed over the access) for 1 of 3 applicable patients (#16) with a Arteriovenous Fistula/Graft (AVF/G) access site out of a total sample of 18 patients. Review of the facility policy, titled Assessment and Cannulation for AV Fistula/Graft and Patient Self Cannulation, effective 1/2020 and revised 10/2023, indicated the following; *Purpose: to provide guidelines for successful cannulation of new and existing arteriovenous fistulas and grafts. Procedure: *Palpate access for thrill.. Use a stethoscope to listen for bruit. i. If thrill and /or bruit are absent: DO NOT cannulate access and notify charge nurse. Charge nurse will asses the AVF/AVG and notify physician if indicated. Absence of the bruit and thrill may indicate a thrombosed access requiring intervention. Document findings and intervention in Electronic Medical Record (EMR). ii. If bruit and thrill are present: inspect access for ecchymotic (bruised) areas, signs of infection (swelling, redness, tenderness, drainage, warmth, etc.). Notify charge nurse if abnormal findings are observed. Document findings and intervention in EMR. During an observation on 12/26/24 at 9:25 A.M., the surveyor observed CCHT #4 as she was preparing Patient #16 for his/her dialysis treatment via an AVF. CCHT #4 palpated the vascular access with her fingertips, disinfected the site, applied the tourniquet, and then inserted the needle into the lower access. She then proceeded to repeat this and insert the second needle into the upper access. CCHT #4 failed to assess for the presence of a bruit with use of the stethoscope. During an interview on 12/26/24 at 9:35 A.M., CCHT #4 said she should have used the stethoscope and listened for a bruit.”

“CFC-INFECTION CONTROL CFR(s): 494.30 This Condition is not met as evidenced by: 38141 Based on observations, record reviews, staff interviews, document review, and policy reviews, the facility failed to ensure that the condition of infection control was met. Eight (8) of 9 facility staff observed, (Registered Nurse [RN] #1 and RN #2, Certified Clinical Hemodialysis Technician [CCHT] #2, CCHT #4, CCHT #6, CCHT #8, CCHT #9, and Patient Care Technician [PCT] #1) failed to perform adequate infection control measures to ensure the health and safety of all patients. Findings include: 1. The facility staff failed to ensure a sanitary environment, related to pest control, to minimize the transmission of infectious agents within and between the Unit. Refer to V111 2. The facility failed to ensure that 1 staff member (CCHT #4) implemented adequate infection control practices, related to glove use and hand hygiene, to reduce the risk of spread of infection while caring for patients. Refer to V113 3. The facility failed to ensure that 3 staff members (RN #1, CCHT #4 and CCHT #6), wore appropriate personal protective equipment (PPE) when there was a potential for contact with body fluids. Refer to V115 4. The facility failed to ensure there was a separation of clean and contaminated items on the dialysis unit. Specifically, the facility failed to 1.) ensure 2 of 2 staff (RN #1 and RN #2) observed, removed potentially contaminated personal protective equipment (PPE) (gowns) before preparing intravenous medication; and 2.) ensure that potentially contaminated personal protective equipment did not come in contact with clean items. Refer to V117 5. The facility failed to 1.) ensure that 2 of 3 staff members (CCHT #2, and PCT #1) observed, adequately cleaned and disinfected contaminated surfaces, medical devices, and equipment within the hemodialysis station, increasing the risk of cross contamination with blood borne pathogens; and 2.) ensure that bleach containers remained covered to prevent weakening of the bleach solution; and 3.) ensure that 8 of 24 dialysis chairs were maintained to enable adequate disinfection. Refer to V122 6. The facility failed to ensure timely administration of the hepatitis B vaccine series for 1 of 2 applicable susceptible patients (#8), out of 10 patient records reviewed, of a total sample of 12 patients. Refer to V126 7. The facility failed to ensure that 1 of 2 staff members observed (CCHT #9) implemented adequate infection control practices during initiation of dialysis treatment for patients with an arteriovenous fistula or graft (AVF/G). Refer to V142 8. The facility failed to ensure that 1 of 2 staff observed (RN #1) utilized aseptic technique when preparing intravenous (IV) medications. Refer to V143 9. The facility failed to ensure that 1 of 2 staff observed (CCHT] #8) performed adequate infection control practices to minimize the risk of infection during exit site care for patients with a Central Venous Catheter (CVC). 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 document review, the facility staff failed to ensure a sanitary environment, related to pest control, to minimize the transmission of infectious agents within and between the Unit. 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. During the flash tour of the storage room on 11/12/24 at 7:55 A.M., the surveyor observed a space under the bottom of the exterior door that may allow pests to enter. The storage room contained sterile items to be used for patient care including, but not limited to dialyzers, blood tubing sets with priming set and transducer protectors, dressing supplies, and syringes. In addition, the storage room led to a hallway, without a barrier to entry, directly to the water room. Review of the facility Pest Control Open Conditions Report, dated 10/30/24, indicated the following: Water/Storage/Utility Areas/Warehouse/Storage/Rodent Glue Board Created 10/23/23: Last inspection 10/30/24. Condition: Space under bottom of exterior door may allow pests to enter. Recommendations: Repair or install Door Sweep. During an interview on 11/13/24 at 2:20 P.M., the Biomedical Technician said there has been a space under the bottom of the exterior door for about a year and although he has tried to make repairs, it has been getting worse. He said pests could get into the storage room which contains sterile supplies and has a hallway, without a door, leading to open access to the water room. He said he has not brought this concern forward to the quality assurance team or governing body.”

“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: 37349 Based on observation, interview, and policy review, the facility failed to ensure that 1 staff member (Certified Clinical Hemodialysis Technician [CCHT] #4) implemented adequate infection control practices, related to glove use and hand hygiene, to reduce the risk of spread of infection while caring for patients. Findings include: Review of the facility policy titled, Hand Hygiene, revised 8/2020, included the following: * Hand hygiene will be performed after gloves are removed. On 11/12/24 at 9:55 A.M., the surveyor observed CCHT #4 disconnect Patient #8 from dialysis treatment. During the discontinuation, CCHT #4 removed her gloves and donned new gloves 3 times without performing hand hygiene. Specifically, after she removed the arterial line from the patient, after she administered heparin through the arterial line, and after she administered heparin through the venous line. During an interview on 11/12/24 at 10:05 A.M., CCHT #4 said she should perform hand hygiene when she changes her gloves.”

“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: 37349 Based on observation, interview, and policy review, the facility failed to ensure that 3 staff members (Registered Nurse [RN] #1, Certified Clinical Hemodialysis Technician [CCHT] #4 and CCHT #6), wore appropriate personal protective equipment (PPE) when there was a potential for contact with body fluids. Findings include: Review of the facility policy titled, Personal Protective Equipment, revised 7/2023, included the following: * It is sometimes necessary for Health Care Personnel (HCP) to wear full PPE to protect their eyes, nose, mouth, face, and body from infectious biohazards or chemical splashes while providing direct patient care and during the performance of other procedures. * Gowns: Sleeves will cover entire arm to wrist area. 1. a. On 11/12/24 at 9:55 A.M., the surveyor observed RN #1 administer intravenous medication to Patient #8. While he administered the medication, the sleeves of his gown did not cover his entire arm and his wrists were exposed. b. On 11/12/24 at 9:55 A.M., the surveyor observed CCHT #4 discontinue dialysis treatment for Patient #8. During the discontinuation, the sleeves of her gown did not cover her entire arm and wrists, and her watch was exposed. During an interview on 11/12/24 at 10:05 A.M., CCHT #4 said the gown should cover her entire arm, her wrist, and her watch should not have been exposed. 10249 c. On 11/12/24 at 8:43 A.M., the surveyor observed CCHT #6 removing dialysis lines from the dialysis machine in station 14. CCHT #6 then discarded the lines in a biohazard container which was located just outside station 14. During this process, CCHT #6 was wearing a mask, however she was wearing her goggles on top of her head. During an interview on 11/12/24 at 9:03 A.M., CCHT #6 said when she was removing the lines on the dialysis machine she realized she had her goggles on top of her head, but did not stop to put the goggles over her eyes.”

“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: 37349 Based on observation, interview, and policy review, the facility failed to ensure there was a separation of clean and contaminated items on the dialysis unit. Specifically, the facility failed to 1.) ensure 2 of 2 staff (Registered Nurse [RN] #1 and RN #2) observed, removed potentially contaminated personal protective equipment (PPE) (gowns) before preparing intravenous medication; and 2.) ensure that potentially contaminated personal protective equipment did not come in contact with clean items. Findings include: Review of the Centers for Disease Control (CDC) Infection Control Requirements for Dialysis Facilities and Clarification Regarding Guidance on Parenteral Medication Vials, dated 8/15/08, included the following: CDC recommends that all parenteral medications should be prepared in a clean area separate from potentially contaminated items and surfaces. In hemodialysis settings where environmental surfaces and medical supplies are subjected to frequent blood contamination, medication preparation should occur in a clean area removed from the patient treatment area. Proper infection control practices must be followed during the preparation and administration of injected medications. This is consistent with official CDC recommendations for infection control precautions in hemodialysis. Review of the facility policy titled, Guidelines for Administration of Medication, Revised 4/2024, included the following: * Medications will be prepared and distributed from a designated clean area. 1. The facility failed to ensure 2 of 2 staff (Registered Nurse [RN] #1, and RN #2) observed, removed potentially contaminated personal protective equipment (PPE) (gowns) before preparing intravenous medication. a. On 11/12/24 at 9:35 A.M., during observation of medication preparation and administration, the surveyor observed RN #1 enter the medication preparation area, labeled clean, wearing a gown that had been worn in and out of dialysis stations to care for patients. At no time did RN #1 remove their gown prior to entering the medication preparation area. He prepared intravenous medication and proceeded to administer the medication to a patient in station 12. During an interview on 11/13/24 at 7:30 A.M., the Facility Administrator said that gowns should not be worn in the clean medication preparation area. b. On 11/13/24 at 10:40 A.M., during observation of medication preparation and administration, the surveyor observed RN #2 enter the medication preparation area, labeled clean, wearing a gown that had been worn in and out of dialysis stations to care for patients. At no time did RN #2 remove their gown prior to entering the medication preparation area. He prepared the intravenous medication and proceeded to administer the medication to a patient in station 17. During an interview on 11/13/24 at 10:45 A.M., RN #2 said that gowns should not be worn in the clean medication preparation area. 2. The facility failed to ensure that potentially contaminated personal protective equipment did not come in contact with clean items. During a flash tour of the treatment area on 11/12/24 at 8:25 A.M., the surveyor observed a PPE gown hanging from an IV pole, with an IV pump attached to the pole, and a PPE gown hanging on a hook on a pillar, in the center of the room, across from station 17. The gown wrapped around the pillar and partially covered the paper towel holder, that was located in a clean sink area. 10249 On 11/13/24 at 11:30 A.M., the surveyor observed PPE (gowns and face shields) hanging from 5 hooks on the wall, located by the entrance/exit of the treatment floor. The PPE observed on the hooks included 7 gowns, 3 face shields, and a stethoscope. The gowns overlapped each other and partially covered the 3 face shields and stethoscope, causing potential concerns for cross contamination. During an interview on 11/14/24 at 8:55 A.M., the Facility Administrator said they need more hooks to hang the gowns. She also said she was not told of this problem by staff.”

“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: 37349 Based on observation, interview, and policy review, the facility failed to 1.) ensure that 2 of 3 staff members (Certified Clinical Hemodialysis Technician [CCHT] #2, and Patient Care Technician [PCT] #1) observed, adequately cleaned and disinfected contaminated surfaces, medical devices, and equipment within the hemodialysis station, increasing the risk of cross contamination with blood borne pathogens; 2.) ensure that bleach containers remained covered to prevent weakening of the bleach solution; and 3.) ensure that 8 of 24 dialysis chairs were maintained to enable adequate disinfection. Findings Include: Review of the facility policy titled, Disinfection and Cleaning of Dialysis Machine Equipment, revised 7/2023, included the following: *Purpose: To provide guidance on proper disinfection of the dialysis station, machine, equipment and surrounding surfaces with the appropriate method prevents the transmission of disease/infection to the dialysis population. *Policy: Label bleach container with concentration, date, time, and initials of individual mixing the bleach solution. Both container and lid must be opaque to prevent weakening of the bleach solution. Container will remain covered at all times. *Procedure: -Clean all external surfaces of the dialysis machine to include top, sides, front and back, blood pressure cuffs and basket; dialysate connectors and lines; hand sanitizer and holder; IV pole, items hanging on pole, attached computer monitors and keyboard/mouse. -Disinfect all surfaces of the prime waste container, inside and out, with a moistened 1:100 bleach cloth. -Clean countertops behind patient station. -Clean ancillary equipment including, but not limited to: oxygen concentrator, acid/bicarb jugs (if applicable), IV pole/pump (if applicable), emergency cart, AED, and suction machine. 1. The facility failed to ensure that CCHT #2 and PCT #1 adequately cleaned and disinfected contaminated surfaces, medical devices, and equipment within the hemodialysis station, increasing the risk of cross contamination with blood borne pathogens a. On 11/12/24 at 8:45 A.M., the surveyor observed CCHT #2 cleaning and disinfecting the dialysis machine/treatment area at station 20 for the next patient. She was observed disinfecting the dialysis machine using 1:100 bleach soaked pads. CCHT #2 failed to disinfect the stethoscope that was hanging from the IV pole. She removed the prime waste container from the right side of the machine, poured the contents of the prime waste container into a dirty sink, and reattached it to the right side of the machine without disinfecting the right side of the machine and all surfaces of the prime waste container, inside and out. She also failed to clean the countertops behind the patient’s station. During an interview on 11/12/24 at 9:20 A.M., CCHT #2 said she did not know she needed to disinfect the prime waste container, but she should have cleaned the stethoscope and the back countertop. b. On 11/12/24 at 8:43 A.M., the surveyor observed PCT #1 as she discontinued treatment for a patient with an AVF, in station 14. PCT #1 was observed to leave the station and retrieve a small hazardous waste container on wheels, and bring it into the station. She discarded the patient’s blood lines into the container, then returned the hazardous waste container back to the center of the room without disinfecting it. PCT #1 was then observed to return to station 14 to complete the termination of the treatment on the patient. During an interview on 11/12/24 at 9:00 A.M., PCT #1 said she does not like to clean while the patient is still at the station. 2. The facility failed to ensure that bleach containers remained covered to prevent weakening of the bleach solution. During observations of the treatment floor, the surveyor observed the following: * On 11/12/24 at 8:25 A.M., the bleach containers from station 17 and 20 were open, allowing for evaporation and weakening of the bleach solution. * On 11/12/24 at 9:32 A.M., the bleach container across from station 17 was open, allowing for evaporation and weakening of the bleach solution. * On 11/12/24 at 10:10 A.M., the bleach container across from station 3 was open, allowing for evaporation and weakening of the bleach solution. * On 11/13/24 at 8:55 A.M., the bleach containers across from stations 3, station 17, station 18, and station 23 were open, allowing for evaporation and weakening of the bleach solution. During an interview on 11/13/24 at 8:55 A.M., Certified Clinical Hemodialysis Technician (CCHT) #1 said that bleach containers should be closed, or it may evaporate, and then you don’t know if its strong enough to disinfect. 3. The facility failed to ensure that dialysis chairs were maintained to enable adequate disinfection in 8 of 24 stations. Observation of the treatment floor indicated the following dialysis chairs had surfaces that were not intact, therefore preventing adequate disinfection of surfaces between patients: * Station 5 - cracks in the seat area with cloth-like material exposed. * Station 8 - cracks in the seat and headrest area with cloth-like material exposed. * Station 9 - cracks in the seat and headrest area with cloth-like material exposed. * Station 10 - cracks in the seat and headrest area with cloth-like material exposed. * Station 12 - cracks in the seat and headrest area with cloth-like material exposed. * Station 13 - cracks in the seat area with cloth-like material exposed. * Station 19 - cracks in the headrest area with cloth-like material exposed. * Station 20 - cracks in seat area with cloth-like material exposed. On 11/12/24 at 8:46 A.M., the surveyor observed CCHT#1 disinfect the dialysis chair in station 20 for the next patient. He used 1:100 bleach soaked cloths over cracks with exposed cloth-like material on the seat of the chair. During an interview on 11/12/24 at 8:50 A.M., CCHT #1 said he does the best he can, but to adequately disinfect the dialysis chair the surface should be intact. 10249”

“IC-HBV-VACCINATE PTS/STAFF CFR(s): 494.30(a)(1)(i) Hepatitis B Vaccination Vaccinate all susceptible patients and staff members against hepatitis B. This Standard is not met as evidenced by: 37349 Based on record review, interview, and policy review, the facility failed to ensure timely administration of the hepatitis B vaccine series for 1 of 2 applicable patients (#8), who were susceptible to the hepatitis B virus, of 10 patient records reviewed, out of a total sample of 12 patients. Findings include: Review of the facility policy titled, Hepatitis B Testing/Vaccination/Seroconversion, revised 11/2022, included the following: *Obtain physician order and offer vaccine to all susceptible patients within 3 days of receiving lab result. First dose should be given within 30 days of admission. Patient #8, admitted to the facility in June 2024 with a diagnosis of End Stage Renal Disease requiring dialysis, and was susceptible to the hepatitis B virus. Review of the medical record indicated that Patient #8 had consented to the administration of the hepatitis B vaccine on 6/25/24. Review of lab reports indicated that Patient #8 was susceptible to the hepatitis B virus with an antibody of less than 4 on 6/27/24 (less than 10 indicates patient is susceptible). Further review indicated that Hepatitis B antigen labs were obtained and was negative on 6/27/24, 7/23/24, 8/27/24, 10/24/24, and 11/5/24. Review of the medical record failed to indicate that the first dose of the hepatitis B vaccine had been administered. During an interview on 11/13/24 at 10:15 A.M., the Facility Administrator said Patient #8 is susceptible to hepatitis B, has consented to the vaccine, and should have received his/her first dose by now.”

“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: 10249 Based on observation, interview, and policy review, the facility failed to ensure that 1 of 2 staff members observed (Certified Clinical Hemodialysis Technician [CCHT] #9) implemented adequate infection control practices during initiation of dialysis treatment for 1 of 2 patients (#11) with an arteriovenous fistula or graft (AVF/G), out of a total sample of 12 patients. Findings include: Review of the facility policy titled, Assessment and Cannulation of AV Fistula/Graft and Patient Self Cannulation, revised 10/2023, included the following: *Disinfect each access site separately with one of the below options: Alcohol prep pad-utilize a rubbing motion for at least 30 seconds. For Patient #11, staff failed to ensure adequate disinfection to both the upper and lower needle access sites of the AVG, per facility policy. On 11/12/24 at 9:30 A.M., the surveyor observed CCHT #9 as she prepared to cannulate Patient #11’s fistula access for dialysis. CCHT #9 was observed to open an alcohol prep pad and disinfected the lower access site for 6 seconds, inserted the needle, then taped the needle in place. CCHT #9 then took a second alcohol prep pad and disinfected the upper access site for 5 seconds, inserted the needle, then taped the needle in place. CCHT #9 failed to disinfect each access site for 30 seconds, per facility policy. During an interview on 11/12/24 at 9:40 A.M., CCHT #9 said she should have rubbed the areas for 30 seconds each.”

“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: 37349 Based on observation, interview, and policy review, the facility failed to ensure that 1 of 2 staff observed (Registered Nurse [RN] #1) utilized aseptic technique when preparing intravenous (IV) medications. Findings include: Review of the facility policy titled, Preparation and Administration of IV/SubQ/IM Medications, revised 2/2023, included the following: Preparation of Medications: Vial * Remove cap protecting the rubber stopper of vial for an unopened vial. * Wipe rubber top of vial with alcohol pad and allow to dry. Preparation of Medication: Mixing Powdered medication: * Inspect the diluent vial for any sediment or floating debris. * Remove cap protecting the rubber stopper of vial for an unopened vial. * Remove cap protecting the rubber stopper of powdered medication vial. * Wipe rubber top of vial with alcohol pad and allow to dry. * Remove correct volume of diluents from the vial. * Remove needle from the diluent vial, insert needle through the rubber stopper of the powdered medication and instill diluent. On 11/12/24 at 9:35 A.M., the surveyor observed RN #1 while preparing medications at the medication counter. Nurse #1 removed the protective cap from a vial of sterile saline (diluent) and removed the protective cap from a vial of Cefazolin powder(an antibiotic). RN #1 used an alcohol pad and disinfected the top of the diluent, inserted a needle and removed diluent from the vial. He removed the needle from the diluent vial and using the same alcohol pad he used on the first vial, he use it a second time on the top of the Cefazolin vial, and proceeded to insert the needle through the rubber stopper to instill the diluent into the vial. He finished the preparation and proceeded to administer the medication to Patient #8. During interview on 11/12/24 at 10:10 A.M., RN #1 said he should not reuse alcohol pads. He said he should use a new alcohol pad for each vial.”

“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: 10249 Based on observation, interview, and policy review, the facility failed to ensure that 1 of 2 staff observed (Certified Clinical Hemodialysis Technician [CCHT] #8) performed adequate infection control practices to minimize the risk of infection during exit site care for 1 of 2 applicable patients (#12), with a Central Venous Catheter (CVC). Findings include: Review of the facility policy titled, Accessing and De-Accessing the Dialysis Catheter, revised 6/2024, indicated the following: * Initiate dialysis per procedure, incrementally increasing BFR to the prescribed rate monitoring arterial and venous pressure. Remove Patient’s mask. Replace underpad if soiled. During an observation on 11/13/24 at 11:30 A.M., the surveyor observed CCHT #8 as she prepared Patient #12 for initiation of his/her dialysis treatment via a CVC. CCHT #8 used a clean barrier (underpad) that she had previously prepared by making a hole in the top portion of the barrier pad. The surveyor observed CCHT #8 thread the 2 lumens through the hole, she opened the clean barrier and laid the 2 lumens onto the barrier, therefore contaminating the barrier. CCHT #8 completed the disinfection process on the lumens and started the dialysis treatment. Without changing the contaminated barrier, CCHT #8 then began the dressing change on the Patient’s exit site. During an interview on 11/13/24 at 11:55 A.M., CCHT #8 said depending on the patient, she likes to get the dialysis treatment started before doing the dressing change. CCHT #8 said she did not think that the underpad needed to be changed before starting the dressing change, and that she always makes a hole in the barrier before using it. During an interview on 11/14/24 at 9:30 A.M., the Facility Administrator said staff should never make a hole in the barrier prior to use.”

“DIALYS PROPORT-MONITOR PH/CONDUCTIVITY CFR(s): 494.40(a) 5.6 Dialysate proportioning: monitor pH/conductivity It is necessary for the operator to follow the manufacturer’s instructions regarding dialysate conductivity and to measure approximate pH with an independent method before starting the treatment of the next patient. This Standard is not met as evidenced by: 37349 Based on observation, record review, interview and document review, the facility failed to 1.) ensure that 2 of 2 staff observed (Certified Clinical Hemodialysis Technician [CCHT] #8 and CCHT #7) followed the facility policy for use of an independent meter to verify final dialysate conductivity and pH; and 2.) ensure conductivity parameters met required ranges prior to initiating each dialysis treatment for 4 of 8 applicable patient (#1, #8, #6, and #7) records reviewed, out of a total sample of 12 patients. Findings include: Review of the facility policy titled, Verification of Final Dialysate-Conductivity and pH, revised 7/2024, included the following: * Prior to dialysis treatment initiation, two direct patient care staff members will observe the conductivity and pH tests being performed and observe the results. NOTE: If the verifications are not performed and the results not observed by both staff members, the second staff member must perform the conductivity and pH a second time to verify the initial results. Both staff members will verify that both the independent meter reading and the actual conductivity value on the machine are within +/- 0.4 milliSiemens/centimeter (mS/cm) of TCD value. * Rinse the meter with Reverse Osmosis (RO) water after each use. 1. The facility failed to ensure that CCHT #8 and CCHT #7 followed the facility policy for use of an independent meter to verify final dialysate conductivity and pH. a. On 11/12/24 at 8:40 A.M., the surveyor observed CCHT #8 use an independent meter to verify the final dialysate conductivity and pH. CCHT #8 obtained a dialysate sample from station 22 and brought it to the testing station. Along with a second staff member, she used the meter to obtain a reading, and without rinsing the meter with RO water, she placed the meter back in the storage stand and went to document the results of the testing. During an interview on 11/12/24 at 9:00 A.M., CCHT #8 said that she should have rinsed the meter with RO water before putting it back. b. On 11/13/24 at 9:00 A.M., the surveyor observed CCHT #7 use an independent meter to verify the final dialysate conductivity and pH. CCHT #7 obtained a dialysate sample from station 7 and brought it to the testing station. Without a second direct care staff member, she used the meter to obtain a reading. She rinsed the meter and documented the results. During an interview on 11/13/24 at 9:05 A.M., CCHT #7 said she can do the test herself. She said another staff member will verify the results she obtained from the meter and that they are within range with the results from the machine, but they don’t have to do another test. During an interview on 11/14/24 at 7:30 A.M., the Facility Administrator said two staff should verify meter conductivity values. She said that the policy to have two staff verify meter results is new, and they are still working on educating all staff. 2. For Patient #1, #8, #6, and #7, the facility failed to ensure conductivity parameters met required ranges prior to initiating each dialysis treatment. a. Patient #1 was admitted to the facility in August 2024 with a diagnosis of End Stage Renal Disease, requiring hemodialysis treatments 3 times a week. Review of 9 treatment sheets, dated 10/22/24 through 11/9/24, indicated that 2 of 9 treatments had variances in conductivity readings that were greater than 0.4 mS/cm, including the following: *10/29/24 - Machine Conductivity 14.0; Meter Conductivity 13.5; Theoretical Conductivity 13.4; the variance was greater than 0.4 mS/cm. *11/5/24 - Machine Conductivity 14.1; Meter Conductivity 14.1; Theoretical Conductivity 13.5; the variance was greater than 0.4 mS/cm. b. Patient #8 was admitted to the facility in June 2024 with a diagnosis of End Stage Renal Disease, requiring hemodialysis treatments 3 times a week. Review of 9 treatment sheets, dated 10/22/24 through 11/9/24, indicated that 2 of 9 treatments had variances in conductivity readings that were greater than 0.4 mS/cm, including the following: *11/2/24 - Machine Conductivity 14.4; Theoretical Conductivity 13.9; the variance was greater than 0.4 mS/cm. *11/9/24 - Machine Conductivity 14.1; Theoretical Conductivity 13.6; the variance was greater than 0.4 mS/cm. 10249 c. Patient #6 was admitted to the facility in July 2024 with a diagnosis of End Stage Renal Disease, requiring hemodialysis treatments 3 times a week. Review of 9 treatment sheets, dated 10/5/24 through 11/9/24, indicated that 3 of 9 treatments had variances in conductivity readings that were greater than 0.4 mS/cm including the following: *10/8/24 - Machine Conductivity 14.2; Theoretical Conductivity 13.6; greater than 0.4 mS/cm. *10/29/24 - Machine Conductivity 13.4; Meter Conductivity 13.9; greater than 0.4 mS/cm. *11/2/24 - Machine Conductivity 13.7; Meter Conductivity 13.0; Theoretical Conductivity 13.5; greater than 0.4 mS/cm. d. Patient #7 was admitted to the facility in October 2024 with a diagnosis of End Stage Renal Disease, requiring hemodialysis treatments 3 times a week. Review of 9 treatment sheets, dated 10/12/24 through 11/7/24, indicated that 2 of 9 treatments had variances in conductivity readings that were greater than 0.4 mS/cm including: *10/12/24 - Machine Conductivity 14.0; Theoretical Conductivity 13.4; greater than 0.4 mS/cm. *10/24/24 - Machine Conductivity 14.5; Meter Conductivity 14.0; Theoretical Conductivity 13.4; greater than 0.4 mS/cm Further review of the documentation For Patient #1, #8, #6 and #7 indicated that no repeat testing of the dialysis machine’s conductivity was performed prior to initiation of treatment for the patients, as required. During an interview on 11/14/24 at 9:30 A.M., the Facility Administrator said if there is a difference of greater than 0.4, staff should repeat the conductivity test.”

“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: 37349 Based on observation, interview, and manufacturer’s recommendations on the label, the facility failed to ensure that staff labeled solutions used to test the independent meter which is used to verify dialysate conductivity and pH, after opening, to be able to determine an expiration date. Findings include: On 11/12/24 at 8:40 A.M., during the flash tour of the treatment floor, the surveyor observed the following at the independent meter testing station: * A plastic bottle, labeled Reverse Osmosis (RO) water, with no date when it was filled. * An open container of Calrite 7.0 pH, with no date it was opened; the manufacturer’s label stated to discard 90 days after opening. * An open container of Calrite 14.0 conductivity solution, with no date when it was opened; the manufacturers label stated to discard 90 days after opening. During an interview on 11/12/24 at 9:00 A.M., CCHT #8 said that RO water should be changed every day, and the Calrite 7.0 solution and Calrite 14.0 solution should be dated to determine when they should be discarded. During an interview on 11/14/24 at 7:30 A.M., the Facility Administrator said that they do not have a facility policy on items in the meter testing station, but RO should be changed daily and the solutions expire per the manufacturer’s recommendations on the label. She said without a date, they are unable to determine when to discard them.”

“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: 10249 Based on record review, and interview, the facility failed to ensure 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 is pushed through the dialyzer and back into the body), and Dialysate 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 2 of 9 applicable patients (Patient #6, and #8) reviewed, out of total sample of 12 patients. Findings include: 1. Patient #6 was admitted to the facility in July 2024 with a diagnosis of End Stage Renal Disease (ESRD), requiring hemodialysis treatments 3 times a week. Review of the physician orders, dated 8/2/24, indicated the dialysis order included a BFR to be delivered at a rate of 400 ml/min, and a DFR to be delivered at a rate of 800 ml/min. Review of the 9 Hemodialysis Flowsheets, dated 10/5/24 through 11/9/24, indicated the BFR and/or DFR had not been delivered as prescribed for 3 of 9 treatments, including the following: *10/5/24 - 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. *11/2/24 - 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. *11/7/24 - The BFR was delivered at a rate of 350 ml/min, not the 400 ml/min as ordered, and the DFR was delivered at a rate of 500 ml/min and not the 800 as ordered, and there was no documentation to indicate why the physician’s order was not followed. During an interview on 11/14/24 at 9:30 A.M., the Facility Administrator said she could not find any documentation as to why the BFR and/or the DFR was not run as prescribed. She also said staff should document why there is a change. 37349 2. Patient #8 was admitted to the facility in June 2024 with a diagnosis of End Stage Renal Disease (ESRD), requiring hemodialysis treatments 3 times a week. Review of the physician orders, dated 6/25/24, indicated the dialysis order included a BFR to be delivered at a rate of 350 ml/min, and a DFR to be delivered at a rate of 600 ml/min. Review of the 9 Hemodialysis Flowsheets, dated 10/22/24 through 11/9/24, indicated the DFR had not been delivered as prescribed for 3 of 9 treatments, including the following: *10/26/24 - The DFR was delivered at a rate of 500 ml/min, not 600 ml/min as ordered, and there was no documentation to indicate why the physician’s order was not followed. *10/31/24 - The DFR was delivered at a rate of 500 ml/min, not 600 ml/min as ordered, and there was no documentation to indicate why the physician’s order was not followed. *11/9/24 - The DFR was delivered at a rate of 500 ml/min, not 600 ml/min as ordered, and there was no documentation to indicate why the physician’s order was not followed. During an interview on 11/14/24 at 9:30 A.M., the Facility Administrator said staff should document why there is a change.”

“POC-OUTCOME NOT ACHIEVED-ADJUST POC CFR(s): 494.90(b)(3) If the expected outcome is not achieved, the interdisciplinary team must adjust the patient’s plan of care to achieve the specified goals. When a patient is unable to achieve the desired outcomes, the team must- (i) Adjust the plan of care to reflect the patient’s current condition; (ii) Document in the record the reasons why the patient was unable to achieve the goals; and (iii) Implement plan of care changes to address the issues identified in paragraph (b)(3)(ii) of this section. This Standard is not met as evidenced by: 10249 Based on record review, interview, and policy review, the facility failed to ensure the Interdisciplinary Team (IDT) periodically reviewed and revised the written, individualized Plan of Care (POC) that includes services to address the patient’s needs and changes in the patient’s condition for 1 of 10 patient’s (#6) records reviewed, out of a total sample of 12 patients. Findings include: Review of the facility policy titled, Comprehensive Interdisciplinary Patient Assessment/Plan of Care (CIPA/POC), last revised 4/2024, indicated the following: *Ongoing evaluation of the patient’s CIPA/POC. *Review and adjust patient’s POC to reflect patient’s current condition and implement POC changes to address the issues identified to achieve the specified goals. For Patient #6, the facility failed to ensure the plan of care was revised when Patient #6’s condition and needs changed regarding missed treatments. Patient #6 was admitted to the facility in July 2024 with diagnoses including End Stage Renal Disease (ESRD), requiring dialysis treatments 3 times a week. Review of the psychosocial assessment, completed on 8/28/24, indicated that the patient requested assistance with housing and transportation. Review of Patient #6’s Plan of Care, dated 9/5/24, indicated the following problem list: *Anemia in chronic Kidney disease *Dependence on renal dialysis *End Stage Renal Disease *Moderate Protein Calorie malnutrition *Other complications of vascular dialysis catheter Review of missed treatment report, dated 11/14/24, indicated that Patient #6 had several missed treatments including: *1 of 14 treatments in August 2024 - 8/29/24. *5 of 12 treatments in September 2024 - 9/7/24, 9/17/24, 9/19/24, 9/24/24, 9/28/24. *7 of 14 treatments in October-10/3/24, 10/10/24, 10/15/24, 10/19/24, 10/22/24, 10/26/24, 10/31/24. *1 of 5 treatments in November to date - 11/5/24. Review of the IDT progress notes in the clinical record indicated the following: -On 10/29/24 the social worker documented that Patient #6 was struggling with loss of independence, stress related to his/her relationship with family and issues with housing. Patient declined mental health support. He/she misses multiple treatments per week, impacting his/her health. MD aware. Social Worker will support patient weekly and recommend weekly mental health supports to help patient’s mood as well as his/her treatment compliance. -On 10/31/24 the dietitian documented that the patient’s phosphorous was very high likely related to missing treatments and not taking binders. The dietitian further documented the patient was struggling with fluid control and following the renal diet. The dietitian documented that the patient has been missing treatments due to social issues (staying with friends); and needs ongoing support and education was provided. During an interview on 11/14/24 at 10:30 A.M., the Social Worker said the patient was having housing issues and was currently living with a friend in another town. He said the move was contributing to the patient not getting to his/her dialysis treatments. The Social Worker said he had not made any changes to the plan of care. During an interview on 11/14/24 at 11:00 A.M., the Facility Administrator said that she was aware of the missed treatments due to housing, but had not made any changes to the plan of care.”

“QAPI-INDICATOR-INF CONT-TREND/PLAN/ACT CFR(s): 494.110(a)(2)(ix) The program must include, but not be limited to, the following: (ix) Infection control; with respect to this component the facility must- (A) Analyze and document the incidence of infection to identify trends and establish baseline information on infection incidence; (B) Develop recommendations and action plans to minimize infection transmission, promote immunization; and (C) Take actions to reduce future incidents. This Standard is not met as evidenced by: 38141 Based on review of the facility Quality Assessment and Performance Improvement (QAPI) meeting minutes, Infection Control Audits, observations, staff interviews, and policy review, the facility failed to ensure monthly Infection Control Audits were completed to ensure they could be consistently measured, analyzed, and a plan developed based on the results of monthly infection control audits. Findings include: Review of the facility policy entitled, “Introduction to Quality Assessment and Performance Improvement [QAPI], with a revision date of 1/2020, included the following, but not limited to: *A Quality Assessment and Performance Improvement program (QAPI) is a well-defined organized program which monitors standards of patient care. The process includes systematically examining patient care, identifying deficiencies, establishing priorities, searching for a probable cause, generating and choosing solutions, implementing the solution, and then re-examining the case. *The purpose of the program is to establish effective problem-focused review and evaluation of quality, safety, and appropriateness of patient care. * Key Program Characteristics of an effective QAPI program: -A central committee for quality assessment and performance Improvement. -The QAPI committee is accountable to the Governing Body of the facility via written documentation. -There are multiple inputs for problem identification. -There are structured procedures for problem analysis (i.e. formal audits and reviews). -The facility develops a database for meaningful analysis. -The QAPI committee develops appropriate recommendations. -The Medical Director of the facility is responsible for the implementation of changes recommended by the QAPI committee. -The QAPI committee conducts regular, periodic re-audits to assess action results. -The Governing Body of the facility periodically evaluates the QAPI program. Review of the Monthly Infection Control Audits, from May 2024 through October 2024, indicated that audits were not completed for 3 of 6 months (June, September, and October 2024), therefore the QAPI committee could not track, trend, or analyze the data. During the survey, the surveyors observed several infection control breaches which included: * Staff failed to ensure a sanitary environment, related to pest control, to minimize the transmission of infectious agents within and between the Unit. * Staff failed to consistently perform hand hygiene. * Staff failed to don appropriate personal protective equipment (PPE). * Staff failed to remove potentially contaminated personal protective equipment (PPE) (gowns), before preparing intravenous medications, and failed to ensure that potentially contaminated PPE did not come in contact with clean items. * Staff failed to adequately clean and disinfected contaminated surfaces, medical devices, and equipment within the hemodialysis station, increasing the risk of cross contamination with blood borne pathogens; and staff failed to ensure that bleach containers remained covered to prevent weakening of the bleach solution; and staff failed to ensure that 8 of 24 dialysis chairs were maintained to enable adequate disinfection. * Staff failed to ensure timely administration of hepatitis B vaccine series for 1 of 2 applicable susceptible patients. * Staff failed to implement adequate infection control practices during initiation of dialysis treatment for patients with an arteriovenous fistula or graft (AVF/G). * Staff failed to utilize aseptic techniques when preparing intravenous (IV) medications. * Staff failed to implement adequate infection control practices during exit site care for patients with a Central Venous Catheter (CVC). Review of the infection control audits indicated the following: *May 21, 2024, the infection control audit had a score of 83.5%. *June 2024, no infection control audits were conducted. *July 30, 2024, the infection control audit had a score of 93.9%. *August 7, 2024, the infection control audit had a score of 72.3%. *September 2024, no infection control audits were conducted. *October 2024, no infection control audits were conducted. During an interview on 11/13/24 at 8:50 A.M., the Facility Administrator said the facility does not have a specific policy for infection control audits. She said the facility utilized the quality manager workbook tool for infection control audits quarterly, at a threshold of 95% (positive rate). She said if the infection control audit score is below 95%, the audit will be repeated monthly until the 95% minimum is reached. During a follow-up interview on 11/14/24 at 11:50 A.M., the Facility Administrator said the results of the infection control audit in May 2024 was below the 95% threshold in which it is triggered to complete a monthly infection control audit. She said this was brought up and reviewed by the Governing Body and an internal survey was conducted in June 2024, but she said she did not have the results of that audit to provide to the surveyor. She said the infection control audit results were not brought forward to the QAPI committee to track and develop a plan of action. She said she is behind and has not done the infection control audit for the months of September and October 2024.”

“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: 37349 Based on observation, interview, document review, review of QAPI meeting minutes, and policy review, the facility failed to ensure that staff brought concerns related to the physical plant forward to Quality Assessment Performance Improvement Committee in order to address issues that hindered a sanitary environment, related to pest control, to minimize the transmission of infectious agents, within and between the Unit. Findings include: Review of the facility policy titled, Introduction to Quality Assessment and Performance Improvement [QAPI]), revised 1/2020, included the following: * A quality assessment and performance improvement program (QAPI) is a well-defined organized program which monitors standards of patient care. The process includes systematically examining patient care, identifying deficiencies, establishing priorities, searching for a probable cause, generating and choosing solutions, implementing the solution and then re-examining the case. Review of QAPI meeting minutes, dated from May 2024 through October 2024, indicated that the Biomed attended the QAPI meetings in May 2024, June 2024, July 2024, September 2024 and October 2024. Further review of the meeting minutes failed to indicate that physical plant concerns related to pest control had been identified and addressed by the QAPI Committee. During the flash tour of the storage room on 11/12/24 at 7:55 A.M., the surveyor observed a space under the bottom of the exterior door that may allow pests to enter. The storage room contained sterile items to be used in patient care including, but not limited to dialyzers, blood tubing sets with priming set and transducer protectors, dressing supplies, and syringes. In addition, the storage room led to a hallway, without a barrier to entry, directly to the water room. Review of the facility Pest Control Open Conditions Report, dated 10/30/24, indicated the following: Water/Storage/Utility Areas/Warehouse/Storage/Rodent Glue Board Created 10/23/23: Last inspection 10/30/24. Condition: Space under bottom of exterior door may allow pests to enter. Recommendations: Repair or install Door Sweep. During an interview on 11/13/24 at 2:20 P.M., the Biomed said there has been a space under the bottom of the exterior door for about a year, and although he has tried to make repairs, it has been getting worse. He said pests could get into the storage room which contains sterile supplies and has a hallway, without a door, leading to open access to the water room. He said he has not brought this concern forward to the quality assurance team or governing body. During an interview on 11/14/24 at 7:30 A.M., the Facility Administrator said she was unaware that there was a space under the bottom of the exterior door, in the storage room. She said best practice would have been to bring that information to Governing Body.”

“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: 10249 Based on observation, record review, staff interview, and policy review, the Medical Director failed to ensure that staff adhered to the heparin administration policy and documented that they waited 3-5 minutes after administration of heparin (blood thinning medication) bolus to initiate dialysis treatment for 2 of 4 applicable patients (#6, and #7), out of a total sample of 12 patients. Findings Include: Review of the facility’s policy titled, Heparinization/Heparin-Free Protocol, last revised 2/2023, indicated the following: *Administer into the second inserted access needle or catheter 3-5 minutes prior to hemodialysis treatment initiation. For Patient #6 and #7, the Medical Director failed to ensure the staff adhered to the heparin administration policy and waited 3-5 minutes after administration to initiate treatment. a. Review of the clinical record indicated Patient #6 had a physician’s order to administer heparin bolus 2000 units intravenously (IV) push, every dialysis treatment. Review of 9 treatment sheets, dated 10/5/24 through 11/9/24, indicated for 5 of 9 treatments staff failed to wait 3-5 minutes after administration of heparin to initiate treatment including the following: *On 10/8/24 treatment started at 2:49 P.M., heparin was documented as administered at 7:25 P.M., after treatment had been completed, not the 3-5 minutes prior to the initiation of dialysis, per the facility policy. *On 10/29/24 treatment started at 2:31 P.M., heparin was documented as administered at 2:31 P.M., at the same time as initiation of treatment, not the 3-5 minutes prior to the initiation of dialysis, per the facility policy. *On 11/2/24 treatment started at 2:57 P.M., heparin was documented as administered at 2:59 P.M., 2 minutes after the initiation of treatment, not the 3-5 minutes prior to the initiation of dialysis, per the facility policy. *On 11/7/24 treatment started at 2:40 P.M., heparin was documented as administered at 5:17 P.M., at the end of treatment, not the 3-5 minutes prior to the initiation of dialysis, per the facility policy. *On 11/9/24 treatment started at 2:37 P.M., heparin was documented as administered at 2:35 P.M., not the 3-5 minutes prior to the initiation of dialysis, per the facility policy. b. Review of the clinical record indicated Patient #7 had a physician’s order to administer heparin bolus 2000 units intravenously (IV) push every dialysis treatment. Review of 9 treatment sheets, dated 10/12/24 through 11/7/24, indicated for 4 of 9 treatments staff failed to wait 3-5 minutes after administration of heparin to initiate treatment including the following: *On 10/24/24 treatment started at 3:42 P.M., heparin was documented as administered at 3:41 P.M., not the 3-5 minutes prior to the initiation of dialysis, per the facility policy. *On 10/29/24 treatment started at 3:31 P.M., heparin was documented as administered at 3:29 P.M., not the 3-5 minutes prior to the initiation of dialysis, per the facility policy. *On 10/31/24 treatment started at 3:35 P.M., heparin was documented as administered at 3:34 P.M., not the 3-5 minutes prior to the initiation of dialysis, per the facility policy. *On 11/2/24 treatment started at 3:53 P.M., heparin was documented as administered at 3:52 P.M., not the 3-5 minutes prior to the initiation of dialysis, per the facility policy. During an interview on 11/14/24 at 9:30 A.M., the Facility Administrator said staff should wait the 3-5 minutes to start treatment after they administer the heparin bolus.”

“GOV-ADM RESP FOR RESOURCES FOR QAPI CFR(s): 494.180(a)(4) The governing body or designated person responsible must appoint an individual who serves as the dialysis facility’s chief executive officer or administrator who exercises responsibility for the management of the facility and the provision of all dialysis services, including, but not limited to- (4) Allocation of necessary staff and other resources for the facility’s quality assessment and performance improvement program as described in §494.110. This Standard is not met as evidenced by: 38141 Based on staff interviews, review of Infection Control Audits, facility document, and policy review, the Governing Body failed to ensure that the Dialysis Unit allocated adequate resources to implement and maintain an effective Quality Assessment Performance Improvement (QAPI) program. Findings include: The Facility failed to consistently monitor, trend and evaluate an effective performance improvement program to identify opportunities for improvement including action plans for in-center hemodialysis patients regarding the facility’s infection control program and procedures. Review of the facility policy titled “Governing Body”, with revision date 1/2020 indicated the following: *The governing body is responsible for: -Assure the healthcare and safety of patients through established ongoing quality management that continually monitors operations and delivery of quality care to ESRD patients. Review of the infection control audits indicated the following: *May 21, 2024, the infection control audit had a score of 83.5%. *June 2024, no infection control audits were conducted. *July 30, 2024, the infection control audit had a score of 93.9%. *August 7, 2024, the infection control audit had a score of 72.3%. *September 2024, no infection control audits were conducted. *October 2024, no infection control audits were conducted. During an interview on 11/14/24 at 8:50 A.M., the Facility Administrator said they do not have a specific policy for infection control audits. She said the facility utilized the quality manager workbook tool for infection control to audit quarterly at a threshold of 95% (positive rate). She said if the infection control audit score is below 95%, the audit will be repeated monthly until the 95% minimum compliance is reached. During a follow-up interview on 11/15/24 at 11:50 A.M., she said she is a member of the governing body and she brought the result of May 2024 infection control audit that were below 95% to the governing body. She said the governing body approved the plan for an internal survey, which was conducted on June 17, 2024 through June 20, 2024, but said she did not have the data of the audit to share with the surveyor. She said that they were to continue with the monthly infection control audits due to continued results below the 95% compliance rate. She said she is behind and has not done the infection control audits for the months of September and October 2024. She said that the governing body resolved/closed the issue despite poor performance of facility staff with infection control audits.”