Davita Gilmer Dialysis

“CFC-INFECTION CONTROL CFR(s): 494.30 This Condition is not met as evidenced by: 48749 Based on observation, record review, and staff interview, the facility’s staff failed to: A. monitor and provide a sanitary environment to minimize the transmission of infectious agents within 3 of 3 areas in the dialysis center. Also, the facility staff failed to follow the facility policy, “Infection Control For Dialysis Facilities”. (Cross Refer to Tag V 0111) B. to ensure medications maintained in the facility were properly safeguarded and not accessible to unauthorized persons. Also, the facility staff failed to ensure that patient nutritional supplies were not stored in the same refrigerator as medications. The facility staff failed to follow the “Medication Policy and Medication Requiring Refrigeration” policies. (Cross Refer to Tag V 0117) C. to follow the correct procedure for cleaning and disinfecting contaminated dialysis equipment and surfaces in the in-center treatment area. The facility staff failed to follow the “Infection Control for Dialysis Facilities” policy. (Cross Refer to Tag V 0122) D. to ensure 1 (Staff # 11) of 1 Licensed Vocational Nurse provided CVC (central venous catheter; a catheter that is inserted into a central vein that leads directly to the heart) care following the facility’s policy and procedure for CVC care. The staff failed to follow the facility’s “Central Venous Clearguard HD Procedure Catheter (CVC)Antimicrobial End With Caps” policy. (Cross Refer to Tag V 0147)”

“CFC-WATER & DIALYSATE QUALITY CFR(s): 494.40 This Condition is not met as evidenced by: 29191 Based on observation, record review, and interview: A. the facility failed to ensure that access to the water purification system was restricted to those individuals responsible for the monitoring and maintenance of the purification system. (Cross Refer to TAG V 0184) B. the facility’s staff failed to review and identify inconsistencies in documentation on the facility’s water treatment log and failed to document action taken to address the time of day that chemical disinfection was initiated. Also, the Bio-Medical technician failed to follow the manufacturer’s instructions for feed water treatment and monitoring to ensure that the RO was operated within its design parameters. (Cross Refer to Tag V 0199) C. the facility staff failed to ensure acid jugs were labeled with date, time, and concentration. Also, the facility failed to follow the policy on “ACID CONCENTRATE SYSTEM, INCOMING ACID CONCENTRATE AND SUPPLY LOG AND USE OF ACID GALLON CONCENTRATE CONTAINERS.” (Cross Refer to Tag V 0228) D. a record review of the bicarbonate system disinfection record, policy review, and staff interview, the staff did not document rinsing the bicarbonate delivery loop and tank daily. Also, the facility staff had 2 different “Daily Bicarb System Acid/Vinegar Clean Logs” that the dialysis technicians were documenting results. (Cross Refer to Tag V 0230) E. the facility’s biomedical staff failed to ensure concentrate outlets were labeled to indicate the type of concentrate in use in 12 of the 12 dialysis stations that were observed. (Cross Refer to Tag V 0245) F. the facility’s Bio-medical staff failed to program hemodialysis machines to the prescribed dialysate concentrate ratio, utilized on patients for 14 of 14 hemodialysis machines. (Cross Refer to Tag V 0248) G. the facility staff failed to ensure the Reverse Osmosis (RO) bottle and the bleach water bottle in the treatment area by the hydrometers had a cap to prevent contamination of the solution. (Cross Refer to Tag V 0250)”

“CFC-PATIENT ASSESSMENT CFR(s): 494.80 This Condition is not met as evidenced by: 48749 Based on record review and interview, A. the Registered Nurse failed to complete the pre-treatment and post-treatment nursing assessments within one hour of treatment on 4 (# 2, # 3, # 4, # 5) of 4 patient medical records reviewed. Also, the facility staff failed to notify the physician of abnormal vital signs on 2 (#3, #4) of 4 patients’ medical records reviewed. The facility staff failed to follow the “Pre-Intra-Post Treatment Data Collection, Monitoring, and Nursing Assessment” policy. (Cross Refer to Tag V 0502) B. the facility staff failed to follow the physician’s prescribed orders for blood flow rate (BFR) and dialysate flow rate (DFR) in 2 (#2, #3) of 4 medical records reviewed. The facility staff failed to follow the “Pre-Intra-Post Treatment Data Collection, Monitoring, and Nursing Assessment” policy. (Cross Refer to Tag V 0503) C. the facility failed to ensure that staff members were not removing greater than 13 milliliters (ml)/ kilograms (kg)/ hour (hr) of fluid on 1 (#2) of 4 patients’ treatment sheets reviewed. Also, the staff failed to follow the facility’s “Pre-Intra- Post Treatment Data Collection, Monitoring, and Nursing Assessment” policy. (Cross Refer to Tag V 0543)”

“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: 48749 Based on observation, record review, and staff interview, the facility staff failed to monitor and provide a sanitary environment to minimize the transmission of infectious agents within 3 of 3 areas in the dialysis center. Also, the facility staff failed to follow the facility policy, “Infection Control For Dialysis Facilities”. This deficient practice had the likelihood to cause harm to patients, staff members, and the public by increasing the risk of transmission of infectious agents within the facility. During a tour of the facility on 09/16/2024 at 9:30 AM, the surveyor observed the following infection control issues in the in-center treatment area, storage room, and laboratory. Findings Include: IN-CENTER TREATMENT AREA: * Observed on entrance to the treatment floor unidentified patient blankets and pillows on the shelf next to the clean gowns for staff and visitors. * Observed a broken light cover above the door to the in-center treatment area. * Observed dead bugs in multiple light covers in the in-center treatment area. * Observed a build-up of dust on the patient privacy screen. Also, rust was observed on the leg of the patient privacy screen. * Observed a build-up of dust and an unknown dried black liquid on the base of the patient Hoyer lift (equipment that allows a person to be lifted and transferred with a minimum of physical effort). * Observed a build-up of dust on the base of the potable blood pressure machine. * Observed paper tape that was peeling off and leaving a sticky residue on the portable oxygen concentrators. The portable oxygen concentrators had an unclean appearance. * Observed two containers of sterile access needles. the plastic containers had an expiration dates of 12/24/21 and 1/21/22 written on the labels. * Observed a drawer at the nurse’s station that was broken. There were pieces of the rolling latch, along with dust and debris particles inside the drawer. * Observed a clutter of papers, a patient’s medication bottle, a phone case, syringes, and a blood tube with an expiration date of 2022 at the nurse’s station. The cabinets underneath the counter at the nurse’s station were cluttered with deodorant spray cans, personal items, papers, and books. *Observed a cardboard box of syringes sitting on the counter of the nurse’s station at the in-center treatment area. “External shipping containers have been exposed to unknown and potentially high microbial contamination. Also, shipping cartons, especially those made of corrugated material; serve as generators of and reservoirs for dust.” (AAM1 ST46-Section 5.2 Receiving items).” *Observed a clutter of sterile needles, sterile syringes, and patient medication cups sitting on the counter in the medication prep area. There was a used bag of hand sanitizer and an open bottle of Welch’s juice sitting on the counter next to the sterile supplies. The staff keys for the medication cabinets and medication refrigerator were stored in the drawer with sterile syringes and were accessible to unauthorized personnel. * Observed an open bottle of antacids with no date of opening, staff initials, or date of discard written on the label. There was a second bottle of antacids with an illegible date written on the label. There were no staff initials or a date of discard found written on the label of the second bottle of antacids. * Observed unknown loose medication capsules on the shelf and an open cardboard box of syringes stored in the cabinet below the medication counter. * Observed tools, an open syringe, and chlorine strips stored together in a dirty discolored tray next to clean and sterile supplies in a cabinet by the clean sink. * Observed open vinegar jugs with the rinse wands attached in a cabinet. The jugs were too tall for the cabinet and tops of the rinse wands were touching the top of the cabinet. There was a rinse wand laying on the shelf. The surveyor was unable to determined if the wand was clean. Also, there was an unknown brown substance around the edge of the rinse wands. * Observed used acid jugs under the cabinet. There was no date of opening, patient information, and staff initials written on the labels. There was an unknown dried brown liquid substance on the back of the shelf. * Observed an accumulation of lint and debris on the Velcro portion of the blood pressure cuffs at the 12 dialysis stations. *Observed dead bugs and a build-up of dust on the wall chases. *Observed an open package of bleed stop sitting on the counter at the nurse’s station. There was no date of opening or initials written on the label. The surveyor was unable to determine if the package had been used. *Observed an open bottle of skin and wound cleanser with an expiration date of 08/24/2024 in a cabinet at the nurse’s station. *Observed an accumulation of an unknown black substance around the faucet of the clean sink at the nurse’s station. * Observed an unknown green substance around the base of the eye wash station faucet. * Observed an accumulation of rust on the cabinet hinges by the clean sink in the nurse’s station. The rust was flaking off the hinges onto the shelf that held clean supplies. * Observed an unknown dried brown substance on the cabinet shelf by the sink in the nurse’s station. * Observed multiple acid and Bicarb wands that were discolored or faded. There was a dead bug and soiled blue pad at the bottom of the plastic bin holding the clean acid and Bicarb wands. *Observed an unknown dried brown liquid running down the front of the dialysis machines of #9 and #11. *Observed a build-up of dust on the backs and bases of multiple dialysis machines being used in the treatment area. * Observed in the corners and the floor of the in-center treatment area was a build-up of dust and dirt particles. STORAGE ROOM: * Observed several plastic containers of clean and sterile supplies on the wire rack shelves with unsecured lids which allowed dust and debris to enter the containers. Also, there was a build-up of dust and debris on the lids of the containers. * Observed a wire rack with clean and sterile supplies in front of the air conditioner intake vent. The air conditioner intake vent had a large amount of dirt and dust build-up. * Observed an unknown dried brown liquid stain on a ceiling tiles in the hallway in front of the storage room. Laboratory: *Observed a build-up of dust on the door and bottom shelf of the laboratory refrigerator. There was an unknown dark substance dried on the top glass shelf holding the patient’s blood tubes. *Observed an unknown dried brown liquid stain on the ceiling tiles above the laboratory sink. * Observed a cup of unknown brown liquid underneath the cabinet. A review of the facility’s “Infection Control For Dialysis Facilities” policy dated April 2023 revealed the following: “PURPOSE: To minimize the spread of infections or bloodborne pathogens in the dialysis facility environment. POLICY: The Centers for Disease Control (CDC) Recommendations for Preventing Transmission of Infections among Chronic Hemodialysis Patients (Dialysis Precautions) will be followed when caring for all patients. Additional precautions recommended by the CDC are to be observed for patients with infectious hepatitis B and are included in the policy: Infection Control and Isolation Measures for Known or Suspected Hepatitis B Antigen Positive Patients. SUPPLIES 8. Supplies will be stored in a manner that maintains their integrity. a. Patient and visitors should not access the supplies. b. Expiration date and package integrity will be verified prior to use. c. Supplies will not be opened until the time of use. d. Anytime the integrity of a package with or without an expiration date is in question, i.e., torn, ripped, wet, or contaminated, the package and its contents must be disposed of and not used. 10. Unused supplies (syringes, alcohol swabs, tape, etc.) or medications (including multiple dose vials containing diluents) taken into the station should be used only for that patient and should not be returned to a common clean area or used on other patients. 11. Measures will be taken to prevent cross-contamination between patients. a. Medication vials, syringes, tape, alcohol swabs, gloves, or other supplies will not be carried in pockets. b. Electronic thermometers and/or blood glucose meters should not be placed on potentially contaminated equipment such as the dialysis delivery system. DISINFECTION 12. Cleaning and/or disinfection of equipment and work surfaces will be performed as soon as possible following exposure to blood or other potentially infectious materials (i.e., used or brought into the station) and prior to returning to clean/designated area or removal from treatment area. a. Prior to routine disinfection, remove all visible blood. * For visible blood or gross blood spills, a 1:10 (one to ten) bleach solution must be utilized. * After all visible blood is cleaned with the 1:10 (one to ten) bleach solution, teammates are to use a new disposable towel soaked with 1:10 (one to ten) bleach solution and clean area a second time. * Cleaning of visible blood should be performed when first observed. b. Use an appropriate disinfectant such as 1:100 (one to one hundred) bleach solution for routine disinfection of environmental surfaces. * Disinfection should be completed by using a wiping motion with friction. * Sufficient disinfectant should be applied so that surfaces are visibly wet. * Surfaces should be allowed to air dry in order to provide sufficient disinfectant contact time. * Items disinfected via submersion will be fully submerged. 13. At the end of each treatment, the dialysis station will be cleaned and disinfected. a. Surfaces to disinfect include but are not necessarily limited to: all surfaces in contact with the patient or their belongings (e.g., dialysis chair, tray tables, blood pressure cuffs) and frequently contacted by healthcare personnel (e.g., control panel; top, front and sides of dialysis machine; touchscreens; countertops). b. Dialysis station must be completely vacated by the previous patient before teammates can begin to bring disinfection supplies to the station, clean or disinfect the station and set up for the next patient. ii. If a patient is not sufficiently stable to be moved from the dialysis station, cleaning, and disinfection of the equipment at the station and preparations for the next patient must be delayed until the patient is able to be safely moved outside the station. c. Dialysis delivery systems with computers/keyboards mounted on top, the computer and keyboard are considered ‘dirty’ equipment 14. Non-disposable items are to be disinfected after each patient use, prior to removal from treatment area/station and if contaminated between uses. If item cannot be cleaned and disinfected it will be dedicated for use on a single patient. a. Stethoscopes will be disinfected with alcohol prep pad and/or 1:100 (one to one hundred) bleach solution and if they are visibly contaminated with blood or body fluids should be disinfected with a 1:10 (one to ten) bleach solution. b. Hemostats (blood line clamps) should be in the open position and fully submerged in an appropriate disinfectant solution. For disinfection of vascular access clamps, please refer to policy: Utilizing Vascular Access Clamps c. Containers used to soak clamps, or other non-disposable equipment will be cleaned and disinfected at the conclusion of the day, or immediately after visible contamination 15. The chair side cart, terminals mounted on the counter, monitor and keyboard are considered clean areas. a. Wipe-able keyboard covers or medical grade keyboards are to be utilized. b. The chair side cart components will be cleaned at the end of each treatment day. c. Sharps containers are not stored on the chair side cart. d. Disposable gloves and alcohol-basehand rub containers may be stored on the chair side cart shelves but not stored on counters where terminals are mounted. e. The monitor screen is cleaned as needed and daily at end of each treatment day using a disposable wipe moistened with 65 - 70% isopropyl alcohol solution. FACILITY HYGIENE 16. 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. 17. Food and drinks in the treatment area will be limited to patients. Sharing and storage in the treatment area are not allowed. a. Sinks must be plumbed with both hot and cold water. b. Clean supplies or equipment will not be placed adjacent to a sink unless a splash guard is in place. c. Soap and a supply of paper towels protected from contamination must be available at each clean sink. An interview with Staff #1 and Staff #3 on 09/17/2024 at 10:00 AM confirmed the infection control and safety issues found in the in-center treatment area, storage room, and laboratory.”

“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: 48749 Based on observation, record review, and interview the facility staff failed to ensure medications maintained in the facility were properly safeguarded and not accessible to unauthorized persons. Also, the facility staff failed to ensure that patient nutritional supplies were not stored in the same refrigerator as medications. The facility staff failed to follow the “Medication Policy and Medication Requiring Refrigeration” policies. Findings include: During a tour of the facility on 09/16/2024 at 9:50 AM with Staff # 9, the surveyor observed: 1. There were six syringes of Venofer 50 milligrams (mg), located on a shelf in an unsecured cabinet in the medication prep area. Also, the keys for the cabinets and medication refrigerator were located in an unsecured clear bin on the counter. 2. Inside the medication refrigerator, there was a bottle of Welch’s juice on the bottom shelf. 3. There were two syringes of Heparin 1,000 units unsecured in a lock box on the counter. The drawer was unlocked with the keys inserted into the lock on the drawer. 4. There was a patient’s prescription bottle of Midodrine 10 mg sitting on the counter, unsecured at the nurse’s station. A review of the facility’s policy “Medication Requiring Refrigeration” dated 04/2017 revealed the following: “PURPOSE: To provide guidance for the storage of medications requiring refrigeration. POLICY: 1. Medications that require refrigeration are stored in the facility refrigerator designated for medications only. 2. The refrigerator is checked twice daily, during facility normal operating hours, for cleanliness and to verify that the temperature remains between 36° F and 46° F. The refrigerator temperature is to be checked by a licensed nurse teammate or designee at the beginning and end of the day. 3. The temperature is documented on the Refrigerator Temperature Log. 4. A separate temperature log is maintained for each medication refrigerator present in the facility. 5. Refrigerators that do not maintain temperatures in the stated range will be repaired or replaced as soon as possible. 6. Per Centers for Disease Control (CDC). place vaccines in center refrigerator space, contained in original packaging, inside designated storage trays positioned 2 - 3 inches from refrigerator walls.” A review of the facility’s policy “Medication Policy” dated 11/2023 revealed the following: “PURPOSE: To provide guidance for medication management in the facility and to provide guidance for the safe and aseptic preparation of all medications. 11. All refrigerated medications, for example, erythropoietin stimulating agents (ESA) and vaccines are to be locked at the close of each business day or if not under supervision by the licensed teammate or per state regulations. Non-refrigerated medications are to be stored in cabinet(s) and locked at the close of each business day or if not under supervision by the licensed teammate or per state regulations. 12. Controlled medications require completion of the medication formulary management process. If approved, daily accounting and disposition of these medications are documented in a log specifically for this purpose. Controlled medications, if administered in the facility, are stored in a safe, locked location that is not accessible to persons other than licensed nurse teammates and the Facility Administrator/designee. 13. All open or unopened medication packages (i.e., vials, ampules, etc.) are stored according to the manufacturer’s directions. Do not use any medication that has been stored improperly or has expired.” According to CDC guidelines for the storage of immunizations: www.cdc.gov/vaccines “Store between 35 and 46 degrees. Place the vaccine in bins with open airflow or leave the top off. Make sure the door is shut. Remove crisper bins and place water bottles labeled ‘Do Not Drink in the bottom.’ Leave 2-3 inches between all vaccine containers and refrigerator walls. Post do not unplug on the refrigerator. Don’t use a dormitory-style refrigerator. Don’t store vaccines on top shelf Don’t put food and beverages in the refrigerator. Don’t put vaccines or diluents in the door or floor of the refrigerator. Don’t drink or remove water bottles.” An interview was conducted on 09/16/2024 with Staff #9 at 9:50 AM. Staff #9 confirmed that medication was left unsecured, the cabinet keys were unsecured, and that patient nutrition was stored in the refrigerator with medications. An interview was conducted on 09/17/2024 with Staff #1 at 10:00 AM. Staff #1 confirmed that a patient’s medication was sitting unsecured on the counter at the nurse’s station.”

“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: 29191 Based on observation and staff interviews the facility staff failed to follow the correct procedure for cleaning and disinfecting contaminated dialysis equipment and surfaces in the in-center treatment area. The facility staff failed to follow the “Infection Control for Dialysis Facilities” policy. These findings had the likelihood to cause harm by increasing the risk of infection to all patients receiving care at the facility by allowing supplies and equipment to be used that had been exposed to microbial contamination and unclean surfaces. Findings include: During a tour of the facility’s in-center treatment area on 09/16/2024 at 2:30 PM the surveyor observed: Staff # 11 was observed cleaning dialysis Stations # 9 and # 12 after the completion of patient treatments. Staff #11 was performing cleaning and disinfection of the dialysis Station following a patient’s hemodialysis treatment. The surveyor observed Staff # 11 open the wings of the dialysis chair, clean them, and promptly close them. The staff member did not allow for adequate drying time of the disinfectant before closing the wings on the chair. During a tour of the facility’s in-center treatment area on 09/16/2024 at 3:00 PM, the surveyor observed: Four dialysis patients complete dialysis treatment and walk to the scale for post-treatment weight. All 4 of the patients touched the handrail and scale buttons without a staff member disinfecting the contaminated surfaces between each patient contact. Also, there were no disinfecting wipes located near the weight station for the patients or staff members to use. A review of the facility’s policy titled, “Infection Control For Dialysis Facilities” with a revision date of April 2023, revealed the following: “PURPOSE: To minimize the spread of infections or bloodborne pathogens in the dialysis facility environment. POLICY: The Centers for Disease Control (CDC) Recommendations for Preventing Transmission of Infections among Chronic Hemodialysis Patients (Dialysis Precautions) will be followed when caring for all patients. Additional precautions recommended by the CDC are to be observed for patients with infectious hepatitis B and are included in the policy: Infection Control and Isolation Measures for Known or Suspected Hepatitis B Antigen Positive Patients... DISINFECTION: 12. Cleaning and/or disinfection of equipment and work surfaces will be performed as soon as possible following exposure to blood or other potentially infectious materials (i.e. used or brought into the station) and prior to returning to clean/designated area or removal from treatment area. b. Use an appropriate disinfectant such as 1:100 (one to one hundred) bleach solution for routine disinfection of environmental surfaces. i. Disinfection should be completed by using a wiping motion with friction. ii. Sufficient disinfectant should be applied so that surfaces are visibly wet. iii. Surfaces should be allowed to air dry in order to provide sufficient disinfectant contact time. iv. Items disinfected via submersion will be fully submerged.” In an interview with Staff #1 on 09/16/2024 at 3:35 PM, Staff #1 confirmed the facility staff were not disinfecting the surfaces at the patient scale and there were no disinfecting wipes in the vicinity of the scale to be utilized by facility staff. Also, Staff #1 confirmed the staff were not allowing appropriate drying time of disinfectant solution on the dialysis chairs.”

“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: 48749 Based on observation, record review, and staff interview, the facility staff failed to ensure 1 (Staff # 11) of 1 Licensed Vocational Nurse provided CVC (central venous catheter; a catheter that is inserted into a central vein that leads directly to the heart) care following the facility’s policy and procedure for CVC care. The staff failed to follow the facility’s “Central Venous Clearguard HD Procedure Catheter (CVC)Antimicrobial End With Caps” policy. This deficient practice had the likelihood to put all patients with a CVC at increased risk for infection. Failure to provide a clean field, perform hand hygiene, and change gloves at the appropriate intervals during procedures with the central venous catheter can lead to cross-contamination (infection) of the catheter. Findings include: During a tour of the facility’s in-center treatment area on 09/16/2024 at 2:45 PM, the surveyor observed Staff #11 performing CVC care. The surveyor observed Staff #11 change gloves 3 times during the CVC access and dressing change. Staff #11 performed hand hygiene twice. There should have been a 5 glove exchange with hand hygiene each time. Also, observed Staff #11 move the swab in a upwards and downward strokes when cleaning the site, which causes cross contamination of the insertion site of the central catheter. In addition, Staff #11 was observed touching the dialysis machine and then touching the CVC site without hand hygiene and changing gloves. The facility’s policy, “Central Venous Cleargaurd HD Procedure Catheter (CVC) Antimicrobial End With Caps” instructs the staff to change gloves a total of 5 times and perform hand hygiene in between glove changes. A review of the facility’s “Central Venous Clearguard HD Procedure Catheter (CVC) Antimicrobial End With Caps” policy dated April 2019 revealed: “Procedure: *Perform hand hygiene per procedure. *Put on PPE and provide a mask to the patient. *Teammate and patient will wear masks covering the nose and mouth during this procedure. If teammate performing this procedure assisted the patient to put on their face mask, re-perform hand hygiene per procedure, and put on clean gloves. *Set up clean field with all appropriate supplies on a clean, moisture-proof barrier. Place patient in a comfortable supine position, as tolerated. *Verify patient’s clothing is secured away from the exit site/work area. *Place the second moisture-proof barrier under catheter limbs. *Instruct patient to turn head to the opposite side of the CVC site. *Remove old dressing and discard. *Observe site for signs and symptoms of infection such as redness, drainage, swelling, or tenderness. If present, report to RN/physician. If drainage is present, obtain an order for exit site culture. *Observe CVC at exit site for evidence of cuff migration, cracks, or leaks in the catheter limbs. If present, do not initiate dialysis. Report to RN/physician for further follow-up. *Verify that both arterial and venous catheter limbs are clamped. *Remove gloves and discard. *Perform hand hygiene per procedure and re-glove. *Holding catheter with the non-dominant hand and using aseptic technique, clean exit site with 2% Chlorhexidine Gluconate/70% Isopropyl Alcohol swab for a minimum of 30 seconds, apply to the CVC exit site in a “back and forth” pattern, using gentle friction progressing from the insertion site to the periphery using both sides of the swab. If site is not free of exudates, repeat this step with new 2% Chlorhexidine Gluconate/70% Isopropyl Alcohol swab. Then wait 60 seconds for air dry time. *Clean each CVC limb/cap with a new LARGE alcohol prep pad starting close to the exit site and finishing with the cap. *Remove gloves and discard, perform hand hygiene per procedure, and re-glove. *Apply antibiotic ointment to exit site, if prescribed. *Place sterile 2 x 2 gauze over the catheter exit site leaving connections accessible. Minimize contact with the 2 x 2 gauze by holding only a comer. Seal edges of gauze with tape; limiting the amount of tape on the limbs. *Apply label to the dressing indicating: * Date dressing change was performed. * Initials of TM performing procedure. *Remove gloves and discard, perform hand hygiene per procedure and re-glove. *Holding catheter with non-dominant hand, use other hand to place sterile 4 x 4 under catheter limbs. Minimize contact with the 4 x 4 gauze by holding only a corner. *Using aseptic technique, remove each cap. One at a time, disinfect each CVC hub with a new alcohol prep pad. Scrub each CVC hub for 15 seconds including the sides, threads, and end of hub thoroughly with friction making sure to remove any residue, for example blood. Hold the limbs until the antiseptic has dried. *Attach sterile 10 ml syringes to the arterial and venous limbs. *Aspirate an amount greater than the catheter limb lumen, generally about 5 ml from each limb. Proceed to step 20 if both limbs are patent. If they are not patent, proceed with step 19. *If unable to aspirate from either arterial or venous limb, attach a 10 ml saline filled syringe to affected limb and gently infuse saline. Reattempt to aspirate. *If able to infuse saline into arterial limb but unable to aspirate, check venous limb for patency. If venous limb is patent, use venous limb for arterial source for this one (1) treatment only. Notify the RN/physician of access insufficiency. If unable to infuse or aspirate from arterial limb, check venous limb for patency, DO NOT use catheter. Notify RN/physician. Refer to procedure: Administration of Cathflo Activase. Draw lab specimens if applicable. Refer to procedure: Obtaining Lab Specimens from Central Venous Catheter (CVC). *All pre-treatment labs should be drawn prior to administrating heparin. Aseptically discard syringe containing indwelling solution from arterial limb and attach a saline-filled syringe. *Repeat step for venous limb. Unclamp and flush each limb with saline and re-clamp. *Attach heparin loading dose to venous limb, as applicable. *Unclamp and gently flush back and forth 3-5 times into catheter. Reclamp. *After a minimum of 3 - 5 minutes, remove syringe from each access port one at a time, then attach each blood line carefully, as not to contaminate blood line tips or catheter limbs. *Secure connections and initiate dialysis per procedure.” During an interview with Staff #11 on 09/16/2024 at 3:00 PM, Staff # 11 stated, “I changed my gloves 3 times during that dressing change.” Staff #11 confirmed that changing gloves and hand hygiene was not completed per the facility’s policy.”

“ENVIRONMENT-SECURE & RESTRICTED CFR(s): 494.40(a) 8 Environment: secure & restricted The water purification and storage system should be located in a secure area that is readily accessible to authorized users. The location should be chosen with a view to minimizing the length and complexity of the distribution system. Access to the purification system should be restricted to those individuals responsible for monitoring and maintenance of the system. This Standard is not met as evidenced by: 29191 Based on observation and interview, the facility failed to ensure that access to the water purification system was restricted to those individuals responsible for the monitoring and maintenance of the purification system. This deficient practice finding had the likelihood to cause harm to all dialysis patients by allowing unauthorized individuals access to the water purification room. Findings include: During a tour of the water room on 09/16/2024 at 11:00 AM, the surveyor observed the water room unsecured. The area was a large room that contained patient supplies and the janitorial staff’s storeroom that contained the cleaning equipment and supplies. This large room allowed unauthorized staff to access the water purification system area. The water room area was not walled off with a separate entry. The key code to the water room was the same for the janitorial staff to enter. All the facility staff including the janitorial staff had access to the water room. An interview with Staff #1 and #2 on 09/16/2024 at 11:00 AM confirmed the water room was unsecured allowing unauthorized access to numerous staff and contract services.”

“RO-MEETS AAMI/MONITORED, RECORDED ON LOG CFR(s): 494.40(a) 5.2.7 Reverse osmosis: meets AAMI/monitored/recorded on log Refer to RD62:2001, 4.3.7 Reverse osmosis: When used to prepare water for hemodialysis applications, either alone or as the last stage in a purification cascade, reverse osmosis systems shall be shown to be capable, at installation, of meeting the requirements of Table 1, when tested with the typical feed water of the user, in accordance with the methods of [AAMI] 5.2.2. 5.2.7 Reverse osmosis Users should carefully follow the manufacturer’s instructions for feed water treatment and monitoring to ensure that the RO is operated within its design parameters. 6.2.7 Reverse osmosis All results of measurements of RO performance should be recorded daily in an operating log that permits trending and historical review. This Standard is not met as evidenced by: 29191 Based on observation, record review, and interview: A. the facility’s staff failed to review and identify inconsistencies in documentation on the facility’s water treatment log and failed to document action taken to address the time of day that chemical disinfection was initiated. B. The Bio-Medical technician failed to follow the manufacturer’s instructions for feed water treatment and monitoring to ensure that the RO was operated within its design parameters. This deficient practice has the likelihood of exposing dialysis patients to chemical disinfection by not documenting when the chemical disinfection was initiated and that the reverse osmosis water system was working properly. Findings include: A. A review of the waterlog titled, “CWP Daily Water Log” on 09/17/2024 with Staff # 16 revealed a reverse osmosis system in place used for the purification of water utilized for hemodialysis patients. A review of the waterlogs for July and August of 2024 revealed the following: Waterlog dated 8/5/2024 “Line #36 Chemical disinfection initiated” there was no time documented to know when the chemical disinfection was initiated. This lack of documentation had the likelihood of exposing dialysis patients to chemical disinfection because it was unknown what time the chemical disinfection was initiated and if patients were being treated at that time. A review of the facility’s water treatment log revealed no documentation that the facility’s staff identified the missing time on the log and/or addressed the issue with the facility’s staff. On 09/17/2024 at 11:00 AM, the surveyor reviewed the facility’s water treatment log with the Facility’s Bio-Medical Technician #16 who concurred with the findings. B. During a tour of the water room on 09/16/2024 at 1:30 PM surveyor was observing the chlorine check with CCHT dialysis technician #12. The CWP (Cold working pressure) water system was making a very loud noise. The surveyor asked what is that noise. Staff #12 stated, “Oh it’s been making that noise for a long time that’s the way it is.” Surveyor reported that was not a normal sound for the CWP. During an interview with the Bio-Medical technician #16 on 09/16/2024 at 2:00 PM was asked what was causing the loud noise with the CWP. Staff #16 reported it is the pressure outlet valve sticking. The surveyor asked can it be fixed. Staff #16 stated, “Yes, I think I have the part.” On the following day 09/17/2024, the CWP water system ran quietly with no loud noise. In an interview with Bio-Medical technician #16 on 09/17/2024 at 9:00 AM confirmed the CWP pressure release valve should have been fixed before the surveyor pointed out the loud noise.”

“MIXING SYSTEMS-LABELING CFR(s): 494.40(a) 5.4.4.1 Mixing systems: labeling Labeling strategies should permit positive identification by anyone using the contents of mixing tanks, bulk storage/dispensing tanks, and small containers intended for use with a single hemodialysis machine. Mixing tanks: Prior to batch preparation, a label should be affixed to the mixing tank that includes the date of preparation and the chemical composition or formulation of the concentrate being prepared. This labeling should remain on the mixing tank until the tank has been emptied. Bulk storage/dispensing tanks: These tanks should be permanently labeled to identify the chemical composition or formulation of their contents. Concentrate jugs: At a minimum, concentrate jugs should be labeled with sufficient information to differentiate the contents from other concentrate formulations used at the facility. This Standard is not met as evidenced by: 29191 Based on observation, record review, and interview, the facility staff failed to ensure acid jugs were labeled with date, time, and concentration. Also, the facility failed to follow the policy on “ACID CONCENTRATE SYSTEM, INCOMING ACID CONCENTRATE AND SUPPLY LOG AND USE OF ACID GALLON CONCENTRATE CONTAINERS.” Findings include: During the tour of the in-center treatment area on 09/16/2024 at 9:30 AM the following issues were observed: * An acid jug of 1 K (potassium) 2.5 Ca (calcium) was sitting directly on the floor without the “date opened” label or staff member’s initials. The acid jug had been removed from station #1 after being used on the patient. * At station #2 an acid jug of 1 K 2.5 Ca was sitting on the ledge of machine #12 without the “date opened” label or staff member’s initials. * At station #4 an acid jug of 1 K 2.5 Ca was sitting on the ledge of machine #10 without the “date opened label” or staff member’s initials. A review of the facility’s policy titled, “ACID CONCENTRATE SYSTEM, INCOMING ACID CONCENTRATE AND SUPPLY LOG AND USE OF ACID GALLON CONCENTRATE CONTAINERS” dated April 2019 revealed the following: “PURPOSE: To provide guidance for acid concentrate distribution and documenting receipt and pump off, where applicable, of acid concentrates. To provide guidance for the use and disposal of acid concentrate containers. ACID GALLON CONCENTRATE CONTAINERS 17. Acid concentrate is to be stored at room temperature in a secure designated area. 18. Upon opening an acid gallon concentrate container, label container with date opened, and initials of teammate. 19. The entire solution volume in the acid gallon concentrate containers should be used prior to opening another acid gallon container of the same concentrate. NOTE: Open, unused acid concentrate solutions remain in the original container, are not to be combined, and should be capped when not in use. 20. Unopened and opened standardized acid concentrate containers must be used prior to the manufacturer’s expiration date on the label, if applicable.” An interview with Staff #12 on 09/17/2024 at 10:00 AM confirmed the acid jugs were not labeled with the date opened and initials of the teammate and that the facility failed to follow the policy.”

“MIXING SYSTEMS-CLEANING CFR(s): 494.40(a) 6.4.1 Mixing systems: cleaning Concentrate mixing equipment should be either: (1) completely emptied, cleaned, and disinfected according to the manufacturer’s instructions; or (2) cleaned and disinfected using a procedure demonstrated by the facility to be effective in routinely producing concentrate meeting [these regulations related to allowable bacterial and endotoxin levels]. The disinfection data should be recorded for each ...disinfection cycle using a dedicated log. This Standard is not met as evidenced by: 29191 Based on a record review of the bicarbonate system disinfection record, policy review, and staff interview, the staff did not document rinsing the bicarbonate delivery loop and tank daily. Also, the facility staff had 2 different “Daily Bicarb System Acid/Vinegar Clean Logs” that the dialysis technicians were documenting results. Findings include: A review of the form titled, “Bicarb System Daily Rinse Log” for July 2024 revealed there was no documentation for daily rinsing of the bicarbonate delivery system per manufacturer recommendations on 07/24/2024. A review of the facility’s policy titled, “BETTER WATER DUAL TANK BICARB MIXING AND DELIVERY SYSTEM NIGHTLY RINSING’ dated 2/28/2013 revealed the following: “NOTE: DO NOT ATTEMPT TO DISINFECT OR CLEAN THE DISTRIBUTION LOOP WHILE PATIENTS ARE CONNECTED TO CENTRAL BICARB LOOP. Validate that all patients are off central loop, prior to cleaning and/or disinfecting. NOTE: This procedure must be performed at the end of each treatment day.” A review of the “Daily Bicarb System Acid/Vinegar Clean Logs” for July and August was a different form and staff were using both forms. The July 2024 form had a pre-clean pH reading, Final Citric Acid/Vinegar level (pH reading), and post-rinse pH reading. The August 2024 form had a pre-rinse water pH reading (RO water in the bicarb mixer prior to Citric Acid/Vinegar clean) and a post-rinse water pH reading (RO water in the bicarb mixer post to Citric Acid/Vinegar clean). In an interview with Staff #1 and #3 on 09/17/2024 at 11:00 AM, Staff # 1 and # 3 acknowledged they did not know that the dialysis technicians were documenting on 2 different “Daily Bicarb System Acid/Vinegar Clean Logs” An interview with Bio-medical technician #16 on 09/17/2024 at 11:00 AM confirmed the staff missed documenting the daily rinse of the bicarbonate delivery loop and tank. Staff #16 acknowledged that he had missed the daily rinse on 07/24/2024 when auditing the Bicarb System Daily Rinse Log and that the dialysis technicians were using 2 different “Daily Bicarb System Acid/Vinegar Clean Logs”.”

“ACID CONC DIST-CONC LABELED & COLOR-CODED RED CFR(s): 494.40(a) 5.5.3 Acid concentrate distribution systems: labeled & color-coded red Acid concentrate delivery piping should be labeled and color-coded red at the point of use (at the jug filling station or the dialysis machine connection). All joints should be sealed to prevent leakage of concentrate. If the acid system remains intact, no rinsing or disinfection is necessary. More than one type of acid concentrate may be delivered, and each line should clearly indicate the type of acid concentrate it contains. This Standard is not met as evidenced by: 29191 Based on observation and interview, the facility’s biomedical staff failed to ensure concentrate outlets were labeled to indicate the type of concentrate in use in 12 of the 12 dialysis stations observed. Findings include: On 09/16/2024 at 9:30 AM during an environmental tour of the facility’s treatment floor, 12 concentrate outlets were observed in use in the facility. The outlets were color-coded red indicating acid in use, but the line did not indicate the type of acid concentrate that was being used through the loop. A review of the policy titled, “ACID CONCENTRATE SYSTEM, INCOMING ACID CONCENTRATE AND SUPPLY LOG AND USE OF ACID GALLON CONCENTRATE CONTAINERS’ dated April revealed the following: “11. All distribution loops, connections and wall boxes will be labeled with correct acid concentrate formulation (such as 1K 2CA...). When distribution loops are installed or repaired a BART ticket will be completed on the verification: * Appropriate connections of the acid concentrate formulations * Distribution loop pressures meet the manufacturer of the dialysis delivery Systems.” In an interview with Staff #12 on 09/16/2024 at 10:30 AM acknowledged the concentrate outlets were not labeled to the type of acid that ran through the loop.”

“DIALYS PROPORT-MATCH RATIO-ALL CONC/MACHINE CFR(s): 494.40(a) 5.6 Dialysate proportioning: match ratio all conc/machine The acid and bicarbonate concentrates [must] be matched with respect to the proportioning ratio and with the model and setup configuration of the dialysis machine. Several types of three-stream concentrates are available, with different ratios of acid concentrate to bicarbonate concentrate to water (see Table 3). The different proportioning types are not compatible with one another. This Standard is not met as evidenced by: 29191 Based on observation and interview, the facility’s Bio-medical staff failed to program hemodialysis machines to the prescribed dialysate concentrate ratio, utilized on patients for 14 of 14 hemodialysis machines. Findings include: Patient #5 On 09/16/2024 at 10:00 Am Patient #5 was observed on the treatment floor of the facility at station #12 hemodialysis machine 2008K2. The Patient was utilizing dialysate concentrate of 2 K (potassium), 3.0 Ca (calcium) from the jug observed connected to the machine. At the request of the Surveyor, the Patient Care Technician (#12) opened the panel on the hemodialysis machine which displayed the dialysate concentrate setting. It was programmed to mix the dialysate concentrate of 2.0 K potassium 2.5 calcium. A review of the Patient’s clinical record, located in the chairside computer revealed a physician’s order for dialysate concentrate of 2.0 potassium and 3.0 calcium. The Surveyor immediately notified the Facility Administrator #1 who also observed the setting of the hemodialysis machine. During an interview on 09/16/2024 at 10:00 AM with Licensed Vocational Nurse #11 who was assigned to patient #5. The Surveyor notified Staff #1, Staff #12, and Staff 11 that the setting for dialysate composition on the patients’ hemodialysis machines was incorrect. Staff #12 stated, “I set the machine for the setting that is closest to the special bath of 2.0 potassium and 2.5 calcium.” The surveyor asked, do you see that the setting for the machine was set incorrectly? Staff #12 stated, “I see it is wrong it is set at 2.5 potassium and 2.5 calcium which is incorrect.” Surveyor and Biomedical technician #16 observed every machine in the facility which consisted of 14 machines. All the machine concentrates were set with the settings of: CT 1K 2.5 45X CT 2K 2.5 45X CT 3K 2.5 45X CT 2K 3.0 45X--- The setting of concentration should have been set at 2.0 K, 3.0 Ca. The nephrologist had ordered 2.0 potassium and 3.0 calcium for Patient #5. Review of the Manufacture’s Direction for Use Manual directs uses as follows: “It is mandatory that acid and bicarb types be matched. These set-ups included machine calibration, special adapters for concentrate type, correct settings of concentrate option, and labeling.” An interview with Bio-medical technician #16 on 09/16/2024 at 11:00 AM acknowledged that he had not programmed the setting of the concentration on all 14 dialysis machines located in the facility, because staff had not informed him of the concentration that the nephrologist had ordered.”

“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: 48749 Based on observation and interview, the facility staff failed to ensure the Reverse Osmosis (RO) bottle and the bleach water bottle in the treatment area by the hydrometers had a cap to prevent contamination of the solution. These findings had the likelihood to cause harm and risk of infection to all in-center patients. An unsecured RO bottle would allow contaminants and microorganisms to enter the water. An unsecured bottle of bleach solution would allow the solutions to deteriorate or break down. This causes the solution to lose its ability to disinfect and eventually become salt and water. Findings include: A tour conducted of the treatment floor on 09/16/2024 at 9:30 AM revealed: A bottle of RO water in the treatment area by the hydrometers was labeled with an opening date of 09/16/2024. There was no cap on the RO bottle. An unsecured RO bottle would allow contaminants and microorganisms to enter the RO water. A bottle of bleach solution in the treatment area by the hydrometers was labeled with an opening date of 09/16/2024. There was no cap on the bleach bottle. This causes the solution to lose its effectiveness to disinfect and eventually become salt and water. An interview with Staff #1 on 09/16/2024 at 10:00 AM acknowledged that the RO bottle and the bleach solution bottle located in the treatment area did not have a cap to prevent contamination and bleach water to become less effective.”

“PE-BUILDING-CONSTRUCT/MAINTAIN FOR SAFETY CFR(s): 494.60(a) The building in which dialysis services are furnished must be constructed and maintained to ensure the safety of the patients, the staff and the public. This Standard is not met as evidenced by: 29191 Based on observation and staff interviews, the facility failed to ensure the emergency pull cord was accessible for a patient in the event they fell on the floor in the lobby. The emergency pull cord should be within 6 inches of the floor. This deficient practice has the likelihood of causing harm to patients in an emergency. Findings include: Upon entering the facility’s lobby on 09/16/2024 at 9:00 AM, the emergency pull cord was blocked by a Hand sanitizer equipment pole. The emergency cord was blocked and not accessible for a patient to call for help in the event the patient fell on the floor. The Hand sanitizer equipment pole remained in front of the call cord for two days until the surveyor informed the Facility Administrator the emergency cord was blocked from the patients. An interview with Staff # 1 on 09/17/2024 at 3:00 PM confirmed the pull cord was blocked by a Hand sanitizer equipment pole and was not accessible for a patient to call for help in the event the patient fell on the floor.”

“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: 29191 Based on record review, observation, and interview, the facility failed to ensure that 8 (#2, #4, #5,#7, #10, #11, #12 and the dialysis chair stored in the supply room) of 13 patient dialysis treatment chairs were maintained in a clean and comfortable manner for patients. This deficient practice had the likelihood to cause harm by increasing the risk of infection to all patients receiving care at the facility by allowing equipment to be used that had been exposed to microbial contamination and unclean surfaces. Findings include: During observation in the patient treatment area on 09/17/2024 at 10:00 AM the following was observed: * Treatment chairs at stations (#2, #4, #5,#7, #10, #11, #12 and the chair stored in the supply room) had torn vinyl back and seat cushions. The foam cushions were cracked and exposed. There was no way to clean the cracked vinyl. An interview with Staff #1 on 09/17//2024 at 10:00 AM reported that the tore vinyl in chairs has been discussed and reported in the Governing body meetings since January 2024. A review of the Governing Body Meetings from January 2024 through July 2024 revealed that the Facility Admistrator had reported the torn vinyl dialysis chairs on each monthly meeting. An interview with Staff #1 on 09/17/2024 at 3:30 PM, confirmed that the dialysis chairs have had cracked vinyl for 9 months and this issue had been reported to upper management.”

“PA-ASSESS CURRENT HEALTH STATUS/COMORBIDS CFR(s): 494.80(a)(1) The patient’s comprehensive assessment must include, but is not limited to, the following: (1) Evaluation of current health status and medical condition, including co-morbid conditions. This Standard is not met as evidenced by: 48749 Based on record review and interview, the Registered Nurse failed to complete the pre-treatment and post-treatment nursing assessments within one hour of treatment on 4 (# 2, # 3, # 4, # 5) of 4 patient medical records reviewed. Also, the facility staff failed to notify the physician of abnormal vital signs on 2 (#3, #4) of 4 patients’ medical records reviewed. The facility staff failed to follow the “Pre-Intra-Post Treatment Data Collection, Monitoring, and Nursing Assessment” policy. Findings Include: Patient #2 A review of 2 of 6 treatment sheets for Patient #2 revealed that pre-treatment and post-treatment nursing assessments were not completed within 1 hour of the patient’s treatment initiation and termination. *A review of the treatment sheet dated 09/04/2024 revealed Staff #7 did not complete the pre-treatment nursing assessment (documented on 09/04/2024 at 4:01 PM) within 1 hour of the initiation of treatment. Treatment was initiated on 09/04/2024 at 12:07 PM. Also, Staff #7 did not complete the post-assessment nursing assessment (documented on 09/04/2024 at 7:44 PM) within 1 hour of treatment termination. Treatment was completed on 09/04/2024 at 4:07 PM. * A review of the treatment sheet dated 09/09/2024 revealed Staff #9 did not complete the pre-treatment nursing assessment (documented on 09/09/2024 at 1:55 PM) within 1 hour of the initiation of treatment. Treatment was initiated on 09/09/2024 at 11:38 AM. Also, Staff #2 did not complete the post-assessment nursing assessment (documented on 09/09/2024 at 6:01 PM) within 1 hour of treatment termination. Treatment was completed on 09/09/2024 at 3:42 PM. Patient #3 A review of 4 of 6 treatment sheets for Patient #3 revealed that a post-treatment nursing assessment was not completed within 1 hour of terminating the patient’s treatment. Also, abnormal vital signs were not reported. *A review of the treatment sheet dated 09/06/2024 revealed Staff #7 did not complete the post-treatment nursing assessment (documented on 09/06/2024 at 6:21 PM) within 1 hour of treatment termination. Treatment was completed on 09/06/2024 at 2:20 PM. *A review of the treatment sheet dated 09/09/2024 revealed Staff #9 did not complete the post-treatment nursing assessment (documented on 09/09/2024 at 6:11 PM) within 1 hour of treatment termination. Treatment was completed on 09/09/2024 at 2:33 PM. Further review of the treatment sheet dated 09/09/2024 revealed Staff #9 and Staff #13 charted the following vital signs: “10:28 AM: BP- 192/85 11:03 AM: BP- 200/100 11:18 AM: BP- 206/95 11:33 AM: BP- 188/89 12:03 PM: BP-184/93” There was no documentation to support Staff #13 reporting the abnormal vital signs to Staff #9(Charge Nurse) or that the Physician was made aware of the abnormal findings. In addition, Patient #3 was discharged at 3:08 PM with a sitting BP of 187/91 and a standing BP of 91/84. There was no documentation to support intervention for the patient’s abnormal vital signs by the facility staff. *A review of the treatment sheet dated 09/11/2024 revealed Staff #9 did not complete the post-assessment nursing assessment (documented on 09/11/2024 at 4:30 PM) within 1 hour of treatment termination. Treatment was completed on 09/11/2024 at 2:10 PM. Further review of the treatment sheet dated 09/11/2024 revealed Staff #13 charted the following vital signs: “10:23 AM: Blood Pressure (BP)- 215/91 11:01 AM: BP- 198/77 11:34 AM: BP- 215/84 2:00 PM: BP- 182/71” There was no documentation to support that Staff #13 reported the abnormal vital signs to Staff #9(Charge Nurse) or that the Physician was made aware of the abnormal findings. There was no documentation to support intervention for the patient’s abnormal vital signs by the facility staff. *A review of the treatment sheet dated 09/13/2024 revealed Staff #7 did not complete the post-assessment nursing assessment (documented on 09/13/2024 at 6:47 PM) within 1 hour of treatment termination. Treatment was completed on 09/13/2024 at 1:45 PM. Patient #4 A review of 6 of 6 treatment sheets for Patient #4 revealed that pre-treatment and post-treatment nursing assessments were not completed within 1 hour of the patient’s treatment initiation and termination. Also, abnormal vital signs were not reported. *A review of the treatment sheet dated 08/14/2024 revealed Staff #7 did not complete the pre-treatment nursing assessment (documented on 08/14/2024 at 6:07 PM) within 1 hour of the initiation of treatment. Treatment was initiated on 08/14/2024 at 3:57 PM. Also, Staff #7 did not verify the patient’s prescription (documented on 09/14/2024 at 5:22 PM) within 1 hour of the initiation of treatment. Treatment was initiated on 08/14/2024 at 3:57 PM. *A review of the treatment sheet dated 08/19/2024 revealed Staff #9 did not complete the pre-treatment nursing assessment (documented on 08/19/2024 at 6:00 PM) within 1 hour of the initiation of treatment. Treatment was initiated on 08/19/2024 at 4:15 PM. *A review of the treatment sheet dated 08/23/2024 revealed Staff #7 did not complete the pre-treatment nursing assessment (documented on 08/23/2024 at 6:53 PM) within 1 hour of the initiation of treatment. Treatment was initiated on 08/23/2024 at 4:30 PM. Also, Staff #7 did not complete the post-assessment nursing assessment (documented on 08/23/2024 at 10:23 PM) within 1 hour of treatment termination. Treatment was completed on 08/23/2024 at 6:27 PM. *A review of the treatment sheet dated 08/28/2024 revealed Staff #7 did not complete the pre-treatment nursing assessment (documented on 08/28/2024 at 9:55 PM) within 1 hour of the initiation of treatment. Treatment was initiated on 08/28/2024 at 4:20 PM. Also, Staff #7 did not complete the post-assessment nursing assessment (documented on 08/28/2024 at 9:56 PM) within 1 hour of treatment termination. Treatment was completed on 08/28/2024 at 6:42 PM. *A review of the treatment sheet dated 09/04/2024 revealed that the patient had a pre-treatment BP of 193/96 and a heart rate (HR) of 115 while standing. Staff #13 charted the following vital signs: “5:58 PM: BP- 210/152 6:28 PM: BP- 182/85 6:58 PM: BP- 185/80 7:28 PM: BP-197/83 7:58 PM: BP-192/86 8:10 PM: BP-197/85 8:21 PM: BP-189/74” There was no documentation to support that Staff #13 reported the abnormal vital signs to Staff #7(Charge Nurse) or that the Physician was made aware of the abnormal findings. There was no documentation to support intervention for the patient’s abnormal vital signs by the facility staff. Staff #7 documented the patient was discharged home at 8:40 PM with a sitting BP of 189/70, a 96 HR, and a standing BP of 202/93 with a HR of 104. *A review of the treatment sheet dated 09/11/2024 revealed Staff #9 did not complete the pre-treatment nursing assessment (documented on 09/11/2024 at 6:23 PM) within 1 hour of the initiation of treatment. Treatment was initiated on 09/11/2024 at 4:38 PM. Further review of the treatment sheet dated 09/11/2024 revealed Staff #12 charted the following vital signs: “4:38 PM: BP- 189/88 5:02 PM: BP- 186/77 5:31 PM: BP- 184/92” There was no documentation to support that Staff #12 reported the abnormal vital signs to Staff #9(Charge Nurse) or that the Physician was made aware of the abnormal findings. There was no documentation to support intervention for the patient’s abnormal vital signs by the facility staff. Patient #5 A review of 3 of 6 treatment sheets for Patient #5 revealed that pre-treatment and post-treatment nursing assessments were not completed within 1 hour of the patient’s treatment initiation and termination. *A review of the treatment sheet dated 09/04/2024 revealed Staff #7 did not complete the post-treatment nursing assessment (documented on 09/04/2024 at 2:14 PM) within 1 hour of treatment termination. Treatment was completed on 09/04/2024 at 10:04 AM. *A review of the treatment sheet dated 09/06/2024 revealed Staff #7 did not complete the post-treatment nursing assessment (documented on 09/06/2024 at 9:30 PM) within 1 hour of treatment termination. Treatment was completed on 09/06/2024 at 10:39 AM. *A review of the treatment sheet dated 09/13/2024 revealed Staff #7 did not complete the pre-treatment nursing assessment (documented on 09/13/2024 at 8:03 AM) within 1 hour of the initiation of treatment. Treatment was initiated on 09/13/2024 at 6:03 AM. Also, Staff #7 did not complete the post-assessment nursing assessment (documented on 09/13/2024 at 12:30 PM) within 1 hour of treatment termination. Treatment was completed on 09/13/2024 at 10:07 PM. A review of the facility policy titled, “Pre-Intra-Post Treatment Data Collection, Monitoring, and Nursing Assessment” dated 04/2024 revealed the following: “PURPOSE: To obtain and document baseline and ongoing information about the patient before, during, and after the dialysis treatment through data collection and nursing assessment. This information will be used in planning and documenting the patient’s dialysis treatment, monitoring during treatment, and for reviewing the patient’s response to the treatment and status prior to discharge. 8. The licensed nurse will round on those patients without reported abnormal findings and complete the nursing assessment within one (1) hour of dialysis treatment initiation or sooner as required by state law. 11. Abnormal findings or findings outside of any patient-specific physician-ordered parameters will be reported to the licensed nurse immediately (refer to the “Abnormal Findings” section in this policy). The licensed nurse will use his/her clinical judgment based on individual patient needs to determine if any clinical interventions are necessary. 12. The licensed nurse notifies the physician (or NPP if applicable) as needed of changes in patient status. 13. All findings, interventions, and patient responses will be documented in the patient’s medical record. ABNORMAL FINDINGS: Unless other abnormal parameters are established by the facility’s Governing Body and documented in the Governing Body Meeting minutes, the following are considered abnormal findings and should be reported to the licensed nurse and documented in the patient’s medical record. Within each category, definitions may be adjusted by a patient-specific physician order. In addition, the teammate who is observing or collecting information should report to the licensed nurse whenever there is concern for the patient’s condition or the potential safety of initiating dialysis, even in the absence of specific abnormal findings. Members of the patient care team should report ANY changes in patient conditions or concerns of patient well-being immediately to the licensed nurse at any time. Fluid Status: Pre-treatment: * Any weight loss from last post-weight * If unable to obtain patient weight, the nurse is to contact physician for orders * Removal goal not to exceed maximum ordered by physician Post-treatment: *If patient is above or below 1 kg from the target weight Blood pressure: Pre-dialysis: * Systolic greater than 180 mm/Hg or less than 90 mm/Hg * Diastolic greater than or equal to 100 mm/Hg or less than 50 mm/Hg Blood Pressure-Intradialytic: * Systolic greater than 180 mm/Hg or less than 90 mm/Hg * Diastolic greater than or equal to 100 mm/Hg or less than 50 mm/Hg * Signs/symptoms of hypotension may include: * Nausea and vomiting * Cold and clammy skin * Restlessness * Rapid, shallow respirations * Excessive yawning * Diaphoretic Blood Pressure Post Treatment: * If the patient can stand: * Standing systolic BP greater than 140 mm/Hg or less than 90 mm/Hg * Standing diastolic BP greater than 90 mm/Hg or less than 50 mm/Hg * If patient is not able to stand, document reason and sitting BP * Sitting BP for patient’s that cannot stand: * Sitting systolic BP greater than 140 mm/Hg or less than 90 mm/Hg * Sitting diastolic BP greater than 90 mm/Hg or less than 50 mm/Hg * Signs/symptoms of hypotension may include: * Nausea and vomiting * Cold and clammy skin * Restlessness * Rapid, shallow respirations * Excessive yawning * Diaphoretic * Dizziness * Feeling faint” An interview was conducted with Staff #1 and Staff #3 on 09/17/2024 at 3:24 PM. Staff #1 stated “The facility staff have been conducting monthly audits on the treatment sheets. I have them do this so they can see the areas that need to be worked on. One of the areas identified was RN assessments.” Staff #3 stated, “I have been reviewing the treatment sheets every 6 months.” Staff #1 and Staff #3 confirmed the facility staff had not documented pre-nursing and post-nursing assessment times within the required time, and that the facility staff did not notify the Physician for a patient with abnormal vital signs.”

“PA-APPROPRIATENESS OF DIALYSIS RX CFR(s): 494.80(a)(2) The patient’s comprehensive assessment must include, but is not limited to, the following: (2) Evaluation of the appropriateness of the dialysis prescription, This Standard is not met as evidenced by: 48749 Based on record review and staff interview, the facility staff failed to follow the physician’s prescribed orders for blood flow rate (BFR) and dialysate flow rate (DFR) in 2 (#2, #3) of 4 medical records reviewed. The facility staff failed to follow the “Pre-Intra-Post Treatment Data Collection, Monitoring, and Nursing Assessment” policy. This deficient practice had the likelihood to harm patients by not following the physician’s dialysis orders which could negatively impact the effectiveness and adequacy of the dialysis treatment for all 35 in-center hemodialysis patients receiving care at this facility. Findings Include: Patient #2 A review of 6 of 6 treatment sheets revealed facility staff did not follow the physician’s prescribed orders for BFR on treatment dates 09/02, 09/04, 09/06, 09/09, 09/11, and 09/13/2024. In addition, the prescription was missing a DFR order that was not identified by the facility staff. *A review of the treatment sheet dated 09/02/2024 revealed the following, “Dialysis Prescription: Blood Flow Rate: 350 ml/min (milliliters per minute) Dialysate Flow Rate: 0.00 ml/min” Staff #6, Staff #9, and Staff #11 documented the following BFR/ DFR throughout the patient’s treatment, “11:29 AM: BFR-400/DFR- 500 11:59 AM: BFR-400/DFR- 500 12:29 PM: BFR-400/DFR- 500 12:59 PM: BFR-400/DFR-500 1:29 PM: BFR-400/DFR-500 1:59 PM: BFR-400/DFR-500 2:30 PM: BFR-400/DFR-500 3:00 PM: BFR-400/DFR-500 3:22 PM: BFR-400/DFR-500” There was no documented order from the physician to adjust the BFR and DFR for this treatment date. *A review of the treatment sheet dated 09/04/2024 revealed the following, “Dialysis Prescription: Blood Flow Rate: 350 ml/min (milliliters per minute) Dialysate Flow Rate: 0.00 ml/min” Staff #11 documented the following BFR/ DFR throughout the patient’s treatment, “12:08 PM: BFR-400/DFR- 500 12:31 PM: BFR-400/DFR- 500 1:01 PM: BFR-400/DFR- 500 1:31 PM: BFR-400/DFR-500 2:01 PM: BFR-400/DFR-500 2:31 PM: BFR-400/DFR-500 3:01 PM: BFR-400/DFR-500 3:31 PM: BFR-400/DFR-500 4:01 PM: BFR-400/DFR-500 4:07 PM: BFR-400/DFR-500” There was no documented order from the physician to adjust the BFR and DFR for this treatment date. *A review of the treatment sheet dated 09/06/2024 revealed the following, “Dialysis Prescription: Blood Flow Rate: 350 ml/min (milliliters per minute) Dialysate Flow Rate: 0.00 ml/min” Staff #11, Staff #13, Staff #14, and Staff #22 documented the following BFR/ DFR throughout the patient’s treatment, “12:32 PM: BFR-400/DFR- 500 1:01 PM: BFR-400/DFR- 500 1:12 PM: BFR-400/DFR-500 1:31 PM: BFR-400/DFR-500 2:01 PM: BFR-400/DFR-500 2:31 PM: BFR-400/DFR-500 3:01 PM: BFR-400/DFR-500 3:31 PM: BFR-400/DFR-500 4:01 PM: BFR-400/DFR-500 4:21 PM: BFR-400/DFR-500” There was no documented order from the physician to adjust the BFR and DFR for this treatment date. *A review of the treatment sheet dated 09/09/2024 revealed the following, “Dialysis Prescription: Blood Flow Rate: 350 ml/min (milliliters per minute) Dialysate Flow Rate: 0.00 ml/min” Staff #11 documented the following BFR/ DFR throughout the patient’s treatment, “ 11:41 AM: BFR-400/DFR- 500 12:05 PM: BFR-400/DFR- 500 12:34 PM: BFR-400/DFR- 500 1:00 PM: BFR-400/DFR-500 1:30 PM: BFR-400/DFR-500 2:02 PM: BFR-400/DFR-500 2:30 PM: BFR-400/DFR-500 3:01 PM: BFR-400/DFR-500 3:35 PM: BFR-400/DFR-500 3:42 PM: BFR-400/DFR-500” There was no documented order from the physician to adjust the BFR and DFR for this treatment date. *A review of the treatment sheet dated 09/11/2024 revealed the following, “Dialysis Prescription: Blood Flow Rate: 400 ml/min (milliliters per minute) Dialysate Flow Rate: 0.00 ml/min” Staff #11, and Staff #13 documented the following DFR throughout the patient’s treatment, “ 11:36 AM: DFR- 500 12:02 PM: DFR- 500 12:32 PM: DFR- 500 1:02 PM: DFR-500 1:33 PM: DFR-500 2:03 PM: DFR-500 2:32 PM: DFR-500 3:02 PM: DFR-500 3:31 PM: DFR-500 3:58 PM: DFR-500” There was no documented order from the physician to adjust the DFR for this treatment date. *A review of the treatment sheet dated 09/13/2024 revealed the following, “Dialysis Prescription: Blood Flow Rate: 400 ml/min (milliliters per minute) Dialysate Flow Rate: 0.00 ml/min” Staff #11, Staff #22, and Staff #7 documented the following DFR throughout the patient’s treatment, “ 11:49 AM: DFR- 500 12:01 PM: DFR- 500 12:31 PM: DFR- 500 1:01 PM: DFR-500 1:31 PM: DFR-500 2:02 PM: DFR-500 2:31 PM: DFR-500 3:02 PM: DFR-500 3:31 PM: DFR-500 3:56 PM: DFR-500” There was no documented order from the physician to adjust the DFR for this treatment date. Patient #3 A review of 1 of 6 treatment sheets revealed facility staff did not follow the physician’s prescribed orders for BFR on treatment date 09/02/2024. *A review of the treatment sheet dated 09/2/2024 revealed the following, “Dialysis Prescription: Blood Flow Rate: 400 ml/min (milliliters per minute) Dialysate Flow Rate: 500 ml/min” Staff #9, Staff #12, and Staff #13 documented the following BFR throughout the patient’s treatment, “10:42 AM: BFR-350 10:58 AM: BFR-350 11:31 AM: BFR-350 11:59 AM: BFR-350 12:03 PM: BFR-350 12:28 PM: BFR-350 12:34 PM: BFR-350” There was no documented order from the physician to adjust the BFR for this treatment date. A review of the facility policy titled, “Pre-Intra-Post Treatment Data Collection, Monitoring, and Nursing Assessment” dated 04/2024 revealed the following: “PURPOSE: To obtain and document baseline and ongoing information about the patient before, during, and after the dialysis treatment through data collection and nursing assessment. This information will be used in planning and documenting the patient’s dialysis treatment, monitoring during treatment, and for reviewing the patient’s response to the treatment and status prior to discharge. 3. Patient identity, prescription, and machine settings are verified by teammate prior to initiation of treatment with the exception of blood flow rate which is verified and documented when the ordered rate is obtained after onset of treatment. The prescription components are confirmed by a licensed nurse within one (1) hour of treatment initiation along with the nursing assessment or as allowable by state law. Prescription components include but are not necessarily limited to: a. Dialyzer make and model b. Treatment time c. Target weight d. UFR and Max UFR e. UF Profiling f. Blood flow rate g. Dialysate flow rate h. All accesses evaluated i. Correct dialysate composition (potassium, calcium, base sodium, and bicarb) and settings j. Heparinization (intradialytic infusion setting” An interview with Staff #1 and Staff #3 on 09/17/2024 at 3:24 PM confirmed the facility staff did not follow the physician’s prescription orders for BFR/DFR on the identified treatment sheets.”

“POC-MANAGE VOLUME STATUS CFR(s): 494.90(a)(1) The plan of care must address, but not be limited to, the following: (1) Dose of dialysis. The interdisciplinary team must provide the necessary care and services to manage the patient’s volume status; This Standard is not met as evidenced by: 48749 Based on record review and interview, the facility failed to ensure that staff members were not removing greater than 13 milliliters (ml)/ kilograms (kg)/ hour (hr) of fluid on 1 (#2) of 4 patients’ treatment sheets reviewed. Also, the staff failed to follow the facility’s “Pre-Intra- Post Treatment Data Collection, Monitoring, and Nursing Assessment” policy. These deficient practices had the likelihood to cause weakness, cramping, and nausea to all patients receiving care at the facility. Findings included: A review of Patient #2’s treatment sheets revealed the facility staff was pulling greater than 13 ml/kg/hr. A review of the treatment sheet for Patient #2 dated 09/13/2024, facility staff removed 16.5 ml/kg/hr of fluid. Upon further review, there was no documentation found in the patient’s medical record to support an order was obtained from the Physician to remove more than 13ml/kg/hr of fluid on 09/13/2024. A review of the facility’s “Pre-Intra- Post Treatment Data Collection, Monitoring, and Nursing Assessment” policy dated October 2015 revealed: “3. Patient identity, prescription and machine settings are verified by teammate prior to initiation of treatment with the exception of blood flow rate which is verified and documented when the ordered rate is obtained after onset of treatment. The prescription components are confirmed by a licensed nurse within one (1) hour of treatment initiation along with the nursing assessment or as allowable by state law. Prescription components include but are not necessarily limited to: a. Dialyzer make and model b. Treatment time c. Target weight d. UFR and Max UFR e. UF Profiling f. Blood flow rate g. Dialysate flow rate h. All accesses evaluated i. Correct dialysate composition (potassium, calcium, base sodium and bicarb) and settings j. Heparinization (intradialytic infusion setting) Fluid Status: Pre-treatment: *Any weight loss from last post-weight. *If unable to obtain patient weight, the nurse is to contact physician for orders. *Removal goal not to exceed maximum ordered by physician. Post-treatment: *If patient is above or below 1 kg from the target weight.” An interview was conducted with Staff #1 and Staff # 3 on 09/17/2024 at 3:24 PM. Staff #1 stated “The staff were doing monthly audits on the treatment sheets to help them identify areas that needed correction. I don’t know how this patient was pulled heavily.” Staff #3 stated “I will check treatment sheets every 6 months. I don’t know what happened with this patient.” During the visit, Staff #1 and Staff # 13 confirmed that there was not an order from the Physician in the patient’s medical record to pull fluid over the standard 13ml/kg/hr.”

“QAPI-MEASURE/ANALYZE/TRACK QUAL INDICATORS CFR(s): 494.110(a)(2) The dialysis facility must measure, analyze, and track quality indicators or other aspects of performance that the facility adopts or develops that reflect processes of care and facility operations. These performance components must influence or relate to the desired outcomes or be the outcomes themselves. This Standard is not met as evidenced by: 29191 Based on record review and interview, the facility staff and governing body failed to address the “Dialysis Facility Report for Fiscal Year 2023” in the Quality Improvement meetings. Findings include: A review of the Quality Improvement meeting minutes from April 19, 2023 revealed the facility had failed to acknowledge the findings reported in the “Dialysis Facility Report for Fiscal Year 2023. An interview with the Facility Manager on 09/17/2024 at 4:00 PM confirmed that she knew about the “Dialysis Facility Report” for 2023 and was mentioned in a Governing Body meeting dated April 19, 2023. There was no way that the facility administrator had addressed the Dialysis Facility Report for 2023 because the report does not get reported to the facility until summer around July 2023. The other issue would be if the Governing Body meeting “date” was transposed wrong. If that was the issue all the governing body meetings were dated 2023 and should have been dated 2024. A review of the Governing Body dated April 19, 2023 mentioned the “DFR reviewed for areas of opportunity. If needed POC will be put into place.” There was no documentation found in the facility quality report that improvements for the outcome indicators had been discussed. A review of the Quality Improvement meeting minutes from August 2023 through August 2024 revealed the Governing Body had no improvement plans implemented or discussed for identified indicators from the “Dialysis Facility Report”. An interview with Staff #1 and #3 on 09/17/2024 at 4:30 PM confirmed the facility had failed to analyze the “Dialysis Facility Report for Fiscal Year 2023” report and failed to implement improvement plans for identified indicators.”