062575 Pavilion Dialysis (Fmc)

“CFC-INFECTION CONTROL CFR(s): 494.30 This Condition is not met as evidenced by: 45020 Based on the manner and degree of the standard level deficiencies referenced to the Condition, it was determined the Condition of Participation §494.30 Infection Control, was out of compliance. V113 - 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. Based on observations, interviews, and document review, the facility failed to ensure standard procedures for infection control were followed in observations conducted during two of three days for patients who presented to the facility for hemodialysis (filtering the blood using a machine and a filter). V121 - Maintaining procedures, in accordance with applicable State and local laws and accepted public health procedures, for the- (i) Handling, storage and disposal of potentially infectious waste. Based on observations and interviews, the facility failed to ensure potentially infectious waste was properly disposed of per facility policy in one of five observations of dialysis stations. V122 - [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. Based on observations and interviews, the facility failed to ensure patient care staff cleaned and disinfected the patient treatment station chair and dialysis machine per facility policy in two of five observations of dialysis station cleaning. V146 - The facility must demonstrate that it follows standard infection control precautions by implementing-] (2) The “Guidelines for the Prevention of Intravascular Catheter-Related Infections” entitled “Recommendations for Placement of Intravascular Catheters in Adults and Children” parts I - IV; and “Central Venous Catheters, Including PICCs, Hemodialysis, and Pulmonary Artery Catheters in Adult and Pediatric Patients,” Based on observations, interviews, and document review, the facility failed to ensure arteriovenous fistula (AVF) (the connection of an artery to a vein) and central venous catheter (CVC) (tubing that allows access to a major vein) exit sites and access threads and hubs were disinfected for the time prescribed by national standards and facility policy in two of three observations of staff accessing AVFs and CVCs. Additionally, the facility failed to ensure that an area designated for clean supplies was clearly separated from the dirty area where there is a potential for contamination with blood or body fluids and areas where contaminated or used supplies are stored for three of three survey days. The failure to separate clean areas from dirty areas had the potential for contamination of clean supplies and could affect 93 in-center patients.”

“CFC-PHYSICAL ENVIRONMENT CFR(s): 494.60 This Condition is not met as evidenced by: 45020 Based on the manner and degree of the standard level deficiencies referenced to the Condition, it was determined the Condition of Participation §494.60 Physical environment, was out of compliance. V401 - The dialysis facility must be designed, constructed, equipped, and maintained to provide dialysis patients, staff, and the public a safe, functional, and comfortable treatment environment. Based on observations, interviews, and document reviews, the facility failed to ensure a safe and functional treatment environment. Specifically, the facility failed to ensure peritoneal dialysis (blood cleaned inside the body using the lining of a person’s abdomen as a filter) (PD) fluids were stored in such a manner as to ensure their integrity and promote safe patient care. Also, the facility failed to ensure medical supplies had not expired and were unavailable for patient use in one of one storage cabinets for dialyzers (used to filter waste and fluid from the blood). V403 - 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. Based on observations, interviews, and document review, the facility failed to ensure expired medications were removed and not available for patient use in one of one patient evacuation supply kits.”

“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: 47962 Based on observations, interviews, and document review, the facility failed to ensure standard procedures for infection control were followed in observations conducted during two of three days for patients who presented to the facility for hemodialysis (filtering the blood using a machine and a filter). Findings include: Facility Policy: According to the Dialysis Precautions policy, dialysis precautions will be followed by all employees with potential exposure to blood-borne pathogens and other potentially infectious material in the dialysis setting. All employees will be educated regarding dialysis precautions, standard precautions, and blood-borne pathogens transmissions as recommended by the Centers for Disease Control (CDC). Dialysis precautions apply during care of all dialysis patients at all times or while performing related activities to prevent disease transmission from exposure to the following: blood, body fluids with visible blood, body tissues, feces, nasal secretions, sputum, sweat, urine, vomit, etc. Reference: According to the CDC Recommendations for Preventing Transmission of Infections Among Chronic Hemodialysis Patients, Infection Control Precautions for all patients, retrieved from https://www.cdc.gov/mmwr/preview/mmwrhtml/rr5005a1.htm, during the process of hemodialysis, exposure to blood and potentially contaminated items can be routinely anticipated; thus, gloves are required whenever caring for a patient or touching the patient’s equipment. Hands always should be washed after gloves are removed and between patient contacts, as well as after touching blood, body fluids, secretions, excretions, and contaminated items. If hands are not visibly soiled, use of a waterless antiseptic hand rub can be substituted for hand washing. The infection control practices recommended for hemodialysis units will reduce opportunities for patient-to-patient transmission of infectious agents, directly or indirectly via contaminated devices, equipment and supplies, environmental surfaces, or hands of personnel. These practices should be carried out routinely for all patients in the chronic hemodialysis setting because of the increased potential for blood contamination during hemodialysis and because many patients are colonized or infected with pathogenic bacteria. 1. The facility failed to ensure patients and staff changed gloves and performed hand hygiene according to facility policy and national guidelines. A. Observations i. On 4/15/24 at 2:55 p.m., an observation was conducted of an arteriovenous fistula (AVF) (artery to vein connection) discontinuation at Station #12. This observation revealed the patient applied pressure to their AVF post-dialysis treatment using their ungloved hand. During this time, patient care technician (PCT) #17 stated the patient needed to hold the access site longer as the patient was still bleeding. Once finished, the patient left the facility without using hand sanitizer or washing their hands. ii. On 4/16/24 at 9:41 a.m., an observation was conducted of an AVF discontinuation at Station #11. This observation revealed the patient applied pressure to their AVF post-dialysis treatment using a gloved hand. Once finished, the patient discarded the glove and left the facility without using hand sanitizer or washing their hands. iii. On 4/16/24 at 9:29 a.m., an observation was conducted of an AVF discontinuation at Station #10. This observation revealed the patient applied pressure to their AVF post-dialysis treatment using a gloved hand. Once finished, the patient discarded the glove and left the facility without using hand sanitizer or washing their hands. iv. On 4/16/24 at 9:33 a.m., an observation was conducted of a central venous catheter (CVC) discontinuation at Station #5. While assisting the patient out of the chair, registered nurse (RN) #14 bent over and the glasses they were wearing as part of their personal protective equipment (PPE) fell onto the floor. RN #14 picked the glasses up using gloved hands and placed them back on their head. They then wheeled the patient off the treatment floor. This observation did not reveal a change of gloves, hand hygiene, or glasses cleaning. At 9:45 a.m., 12 minutes later, RN #14 dropped their glasses onto the floor a second time and they were observed washing the glasses with soap and water at the sink. At this time, RN #14 stated they were cleaning the glasses now as they had fallen onto the floor. They stated they had not paid attention to their glasses falling the first time so had not cleaned them earlier. These observations of patients and staff were in contrast to the Dialysis Precautions policy and CDC Recommendations for Preventing Transmission of Infections Among Chronic Hemodialysis Patients which read, hands were always washed or antiseptic hand rub used after gloves were removed, as well as after touching blood, body fluids, secretions, excretions, and contaminated items. These practices were carried out routinely in the hemodialysis setting because of the increased potential for blood contamination during hemodialysis and because many patients were colonized or infected with pathogenic bacteria. B. Interviews i. On 4/17/24 at 8:16 a.m., an interview was conducted with RN #13. RN #13 stated hand hygiene consisted of removing gloves and applying hand sanitizer. In contrast to observations made on the treatment floor on 4/15/24 and 4/16/24, RN #13 stated hand hygiene was expected of patients after applying pressure to their dialysis access sites. They also stated moving from dirty to clean areas required the removal of gloves and sanitizing hands which was in contrast to observations made of RN #14 on 4/16/24. RN #13 stated hand hygiene was important for staff and patients to prevent the transfer of bacteria which could lead to infections and hospitalizations for dialysis patients. ii. On 4/17/24 at 10:53 a.m., an interview was conducted with charge RN (Charge RN) #3. Charge RN #3 stated staff encouraged patients to perform hand hygiene after applying pressure to their access sites, which was in contrast to observations of the treatment floor on 4/15/24 and 4/16/24. Charge RN #3 stated this process was important as patients may have touched their own blood or had other infectious agents on their hands which could lead to the transfer of pathogens (disease-causing microorganisms) to other patients. Charge RN #3 stated there was a risk of spreading Hepatitis B, influenza, or COVID-19 if hands were not sanitized. iii. On 4/17/24 at 10:01 a.m., an interview was conducted with medical director (Medical Director) #1. Medical Director #1 stated patients were educated on dialysis care. They stated gaps in infection control by patients and staff created a risk of infection, specifically endocarditis (inflammation of the heart) and brain and spine abscesses (pockets of pus), amongst others.”

“IC-SUPPLY CART DISTANT/NO SUPPLIES IN POCKETS CFR(s): 494.30(a)(1)(i) If a common supply cart is used to store clean supplies in the patient treatment area, this cart should remain in a designated area at a sufficient distance from patient stations to avoid contamination with blood. Such carts should not be moved between stations to distribute supplies. Do not carry medication vials, syringes, alcohol swabs or supplies in pockets. This Standard is not met as evidenced by: 28297 Based on observation, interview, and policy review, the facility failed to ensure that an area designated for clean supplies was clearly separated from the dirty area where there is a potential for contamination with blood or body fluids and areas where contaminated or used supplies are stored for three of three survey days. The failure to separate clean areas from dirty areas had the potential for contamination of clean supplies and could affect 93 in-center patients. Findings include: Observation on 04/15/24 at from 10:20 AM until 1:30 PM revealed the red biohazard container used to dispose of used dialyzers and hemodialysis lines, was sitting across from Station 6, 18, and 19 were right next to an area where multiple clean supplies including dialyzers, dialysis lines and initiation packs for the next patient were stored. Observation on 04/16/24 from 8:50AM until 10:15AM revealed the red biohazard container was stored next to the area that clean supplies for the next patient were stored across from Station 6, 18, and 19. Observation on 04/17/24 from 10:05 AM until 10:30 AM revealed the red biohazard containers were stored next to the area that clean supplies for the next patient including dialyzers, lines, and initiation packs across from Station 2, 6, 18 and 18. Observation on 04/17/24 at 10:25 AM revealed Patient Care Technician (PCT) 17 removed the dirty lines and dialyzer from Station 20 and carried them across the treatment floor to the biohazard container across from Station 18. During an interview on 04/17/24 at 10:25 AM PCT17 stated no one had ever said anything about the biohazard containers being stored next to the clean supplies, but confirmed they were too close together and should be moved away from the clean supplies. During an interview on 04/17/24 at 10:30 AM Registered Nurse (RN) 13 and the Charge Nurse confirmed the biohazard containers were stored to close to the clean supplies across from Station, 2, 6, 18 and 19 that there was a risk of contamination of clean supplies when soiled items were thrown in the biohazard containers. Review of the facility policy’s titled, “Dialysis Precautions,” revised 01/04/12, indicated, “Clean areas should be clearly separated from dirty areas where used supplies, equipment or blood samples are handled or stored.””

“IC-HANDLING INFECTIOUS WASTE CFR(s): 494.30(a)(4)(i) [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- (i) Handling, storage and disposal of potentially infectious waste; This Standard is not met as evidenced by: 47962 Based on observations and interviews, the facility failed to ensure potentially infectious waste was properly disposed of per facility policy in one of five observations of dialysis stations. Findings include: Facility policies: According to the General Cleanliness and Infection Control Guidelines policy, contaminated sharps shall be discarded immediately or as soon as possible in containers designed to close, are puncture-resistant, and leak-proof on the sides and bottom. According to the Cleaning and Disinfecting the Dialysis Station policy, the purpose is to prevent the spread of infectious diseases and to maintain a clean and safe environment for patients. Pick up all trash or visible medical debris from around the station chair. 1. The facility failed to ensure a dirty needle was disposed of per facility policy. A. Observations i. On 4/15/24 at 2:29 p.m., an observation was conducted of patient care technician (PCT) #10 at Station #1 during the set-up for a new patient treatment. Observations revealed an uncapped needle lying on the floor under the base of the dialysis chair and several feet away, an accessible sharps container mounted to the dialysis station. This observation of the uncapped needle lying on the floor was in contrast to the General Cleanliness and Infection Control Guidelines and Cleaning and Disinfecting the Dialysis Station policies which read, contaminated sharps were discarded immediately in containers that were puncture-resistant and leak-proof. This was done to prevent the spread of infectious diseases and to maintain a safe environment for patients. An interview with PCT #10 on 4/15/24 at 2:45 p.m. revealed PCT #10 was unaware of the needle. Another interview with registered nurse (RN) manager (RN Manager) #11 on 4/15/24 at 2:45 p.m. revealed staff were expected to clean the entire station, including the base of the chair, after each patient treatment which was in contrast to the observation of the uncapped needle lying underneath the chair. B. Interviews i. On 4/16/24 at 10:30 a.m., an interview was conducted with PCT #15. PCT #15 stated chairs were cleaned between patient treatments which was in contrast to the observation made of Station #1 on 4/15/24. They stated contact with someone else’s blood posed a risk to patients and proper station cleaning decreased the risk of contamination and transfer of infectious agents. ii. On 4/17/24 at 8:16 a.m. an interview was conducted with RN #13. RN #13 stated all areas of the chairs and station were cleaned between patient treatments. They stated used needles were disposed of in the sharps container which was in contrast to the observation made of Station #1 on 4/15/24. RN #13 stated the uncapped needle found on the floor was considered dirty. They stated a needlestick with a dirty needle created a risk for an infection or disease, for instance, Hepatitis B (infection of the liver).”

“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: 47962 Based on observations and interviews, the facility failed to ensure patient care staff cleaned and disinfected the patient treatment station chair and dialysis machine per facility policy in two of five observations of dialysis station cleaning. Findings include: Facility policy: According to the Cleaning and Disinfecting the Dialysis Station policy, the purpose is to prevent the spread of infectious diseases and to maintain a clean and safe environment for patients. The chair and dialysis equipment are used by multiple patients during a treatment day and it is critical that the chair and equipment be thoroughly cleaned and disinfected between uses. The dialysis station could become contaminated with blood and other body fluids during treatment. All work surfaces shall be cleaned and disinfected with 1:100 bleach solution after completion of procedures. Make the surface glistening wet and let air dry before setting up for the next treatment. Use a cloth wetted with 1:100 bleach solution to clean and disinfect the dialysis station (chair/bed, machine, etc). Place the chair in the Trendelenburg position and open side panels so all surfaces are accessible. Clean all surfaces. Make the surfaces glistening wet and allow to air dry. Pick up all trash or visible medical debris from around the station chair. Reference: The manufacturer’s instructions for use (IFU) for the Pure Bright Bleach read, for sanitizing work surfaces: cover the surface with the bleach solution for at least two minutes and let air dry. 1. The facility failed to clean and disinfect the dialysis station between patient treatments according to facility policy. Direct patient care staff did not thoroughly wipe all visible surfaces of the chair or place the dialysis chair into the fully reclined position to clean all surfaces. Also, direct patient care staff did not allow all surfaces of the dialysis chair to completely air dry after surfaces were wiped with a bleach solution before closing the chair. Additionally, the station was set up for the next treatment before all surfaces were allowed to air dry per facility policy. A. Observations i. On 4/15/24 at 1:50 p.m., patient care technician (PCT) #10 was observed as they disinfected the dialysis chair at Station #2. PCT #10 wiped the chair with a bleach solution, however, they did not place the chair into a fully reclined position to wipe the crevices of the chair seat. PCT #10 then folded the chair back into a sitting position while the chair remained visibly wet and did not allow time for the surfaces to air dry. This observation was in contrast to the Cleaning and Disinfecting the Dialysis Station policy which read, all surfaces of the treatment station were wiped with a bleach solution until glistening wet and left to air dry before setting up for the next treatment, and the chair was opened so all surfaces were accessible. This was also in contrast to the IFU for the Pure Bright Bleach which read, the surfaces were covered with a bleach solution for at least two minutes and left to air dry. ii. On 4/15/24 at 2:29 p.m., PCT #10 was observed as they disinfected the dialysis chair and machine at Station #1. PCT #10 wiped the chair and machine with a bleach solution, however, they did not place the chair into a fully reclined position to wipe the crevices of the chair seat. PCT #10 then folded the chair back into a sitting position while the chair remained visibly wet and did not allow time for the surfaces to air dry. Additionally, PCT #10 set up the dialysis machine for the next treatment while the machine remained visibly wet. This observation was in contrast to the Cleaning and Disinfecting the Dialysis Station policy which read, all surfaces of the treatment station were wiped with a bleach solution until glistening wet and left to air dry before setting up for the next treatment, and the chair was opened so all surfaces were accessible. This was also in contrast to the IFU for the Pure Bright Bleach which read, the surfaces were covered with a bleach solution for at least two minutes and left to air dry. B. Interviews i. On 4/16/24 at 10:30 a.m., an interview was conducted with PCT #15. PCT #15 stated stations were cleaned with a bleach solution to disinfect surfaces between patient treatments. They stated accessing patients’ blood during dialysis treatment created a risk of contamination if surfaces were not properly cleaned. PCT #15 stated there was a risk pathogens (disease-causing microorganisms) could be transferred from patient to patient due to improper cleaning of dialysis stations. ii. On 4/16/24 at 9:53 a.m., an interview was conducted with registered nurse (RN) #14. RN #14 stated the dialysis chair was laid flat while cleaning the station to clean the entire chair. They stated blood could form invisible droplets which traveled everywhere and it was important for patient safety to ensure all treatment surfaces were cleaned. iii. On 4/17/24 at 8:16 a.m., an interview was conducted with RN #13. RN #13 stated all areas of the chairs were cleaned during station cleaning as blood could hide in a nook or cranny. They stated chairs and machines were supposed to be glistening wet to ensure thorough cleaning and then left to air dry. RN #13 stated treatment surfaces cleaned with bleach and not allowed to air dry, for example, the observations made of PCT #10 on 4/15/24 which revealed treatment chairs folded into place while still wet and a station set up for the next treatment while still wet, were considered dirty. They also stated PCT #10 was one of the preceptors at the facility. RN #13 stated this cleaning process was important as it would not be safe for patients to have contact with another patient’s blood due to the risk of infection, for instance, Hepatitis B (liver infection).”

“IC-CATHETERS:GENERAL CFR(s): 494.30(c)(2) (2) The “Guidelines for the Prevention of Intravascular Catheter-Related Infections” entitled “Recommendations for Placement of Intravascular Catheters in Adults and Children” parts I - IV; and “Central Venous Catheters, Including PICCs, Hemodialysis, and Pulmonary Artery Catheters in Adult and Pediatric Patients,” Morbidity and Mortality Weekly Report, volume 51 number RR-10, pages 16 through 18, August 9, 2002. The Director of the Federal Register approves this incorporation by reference in accordance with 5 U.S.C. 552(a) and 1 CFR Part 51. This publication is available for inspection as the CMS Information Resource Center, 7500 Security Boulevard, Central Building, Baltimore, MD or at the National Archives and Records Administration (NARA). Copies may be obtained at the CMS Information Resource Center. For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal_register/code_of_regulations/ibr_locations.html This Standard is not met as evidenced by: 45020 Based on observations, interviews, and document review, the facility failed to ensure arteriovenous fistula (AVF) (the connection of an artery to a vein) and central venous catheter (CVC) (tubing that allows access to a major vein) exit sites and access threads and hubs were disinfected for the time prescribed by national standards and facility policy in two of three observations of staff accessing AVFs and CVCs. Findings include: Facility policies: The Termination of Treatment Using a Central Venous Catheter and Optiflux Single Use Ebeam Dialyzer policy read, disconnect the arterial bloodline line from the catheter limb. Using a sterile alcohol pad scrub the sides (threads) and end of the hub thoroughly with friction, making sure to remove any residue (e.g., blood) (This step should take 10-15 seconds). Hold the limb while allowing the antiseptic to dry. Immediately attach a prefilled saline syringe to the catheter limb. Repeat these steps for the venous end of the catheter limb. The Access Assessment and Cannulation policy read, the access must be prepared properly for needle placement to prevent bacteria from entering the bloodstream through the skin. Disinfect cannulation site as follows using any of the disinfectants below: 2% Chlorhexidine and 70% Alcohol work outward 2 inches in a concentric circle using gentle back and forth friction to clean for a minimum 30 seconds and allow to dry before cannulating. 1. The facility failed to ensure direct care staff disinfected arteriovenous fistula and central venous catheter exit sites, limbs, and hubs according to national standards and facility policy. A. Observations i. On 4/15/24 at 1:24 p.m., an observation was conducted of a CVC discontinuation at station #2. Patient care technician (PCT) #10 scrubbed the venous hub with an alcohol swab for 30 seconds, no dry time was observed, PCT #10 then immediately flushed the line with normal saline. PCT #10 scrubbed the arterial hub with an alcohol swab for 20 seconds, no dry time was observed, PCT #10 immediately flushed the line with normal saline. PCT #10 then inserted Heparin (a medication used to prevent clots) into each line and screwed on the caps. This observation was in contrast to the The Termination of Treatment Using a Central Venous Catheter and Optiflux Single Use Ebeam Dialyzer policy, which read, hold the limb while allowing the antiseptic to dry. ii. On 4/15/24 at 2:01 p.m., an observation was conducted of a AVF initiation of treatment at station #4. PCT #10 cleansed the distal access site with chlorhexidine for 5 seconds, allowed the area to air dry, applied the tourniquet, cannulated the distal site and secured the needles with tape. This observation was in contrast to the Access Assessment and Cannulation policy which read, disinfect cannulation site as follows using any of the disinfectants below: 2% Chlorhexidine and 70% Alcohol work outward 2 inches in a concentric circle using gentle back and forth friction to clean for a minimum 30 seconds and allow to dry before cannulating. B. Interviews i. On 4/17/24 at 10:01 a.m., an interview was conducted with medical director (Director) #1. Director #1 stated catheters were the biggest risk for bloodstream infections and frequent audits, which included watching staff were performed. Director #1 stated patients are asked to wash their access site upon entrance to the treatment floor to minimize infection risk. Director #1 stated infection could cause endocarditis (a life-threatening inflammation of the inner lining of the heart’s chambers and valves), abscesses (an area of tissue becomes infected), and was a huge cause of morbidity (the condition of suffering from a disease or medical condition). ii. On 4/17/24 at 8:16 a.m., an interview was conducted with registered nurse (RN) #13. RN #13 stated CVC and AVF audits were performed to ensure safe patient care and treatment and to reduce the risk of infections. iii. On 4/16/24 at 10:00 a.m., an interview was conducted with PCT #16. PCT #16 stated CVC hubs were to be scrubbed for 15 seconds and allowed to air dry. PCT #16 stated this was important because the CVC was a pathway of infection to the patient’s heart. iv. On 4/16/24 at 10:46 a.m., an interview was conducted with PCT #14. PCT #14 stated it was important to follow facility policies to decrease the risk of infection. PCT #14 stated the policies and procedures were designed to protect the patients.”

“PE-SAFE/FUNCTIONAL/COMFORTABLE ENVIRONMENT CFR(s): 494.60 The dialysis facility must be designed, constructed, equipped, and maintained to provide dialysis patients, staff, and the public a safe, functional, and comfortable treatment environment. This Standard is not met as evidenced by: 48269 Based on observations, interviews, and document reviews, the facility failed to ensure a safe and functional treatment environment. Specifically, the facility failed to ensure peritoneal dialysis (blood cleaned inside the body using the lining of a person’s abdomen as a filter) (PD) fluids were stored in such a manner as to ensure their integrity and promote safe patient care. Also, the facility failed to ensure medical supplies had not expired and were unavailable for patient use in one of one storage cabinets for dialyzers (used to filter waste and fluid from the blood). Findings include: Facility policies: According to the Guidelines for Warming Peritoneal Dialysis Solutions, the purpose is to establish safe standards for warming peritoneal dialysis (PD) solutions. To reduce possible discomfort during administration, PD solutions may be warmed to 98° Fahrenheit (F) prior to use. Follow the guidelines below to ensure PD solutions are warmed safely. General handling: PD solutions should be warmed shortly before use. Heating options: PD solutions may be warmed with dry heat using a heating pad, cycler warming tray, fluid warmer, warming cabinet, body heat, or natural sunlight. Heating pads should be used on the lowest setting for up to three hours at a time. Wrapped solutions may be warmed on the cycler warmer tray and fluid warmer or in the warming cabinet for up to 45 days. Label the solution package with the date placed in/on the warmer. Frequent rotation of solution stock is recommended. The Expiration Dates Sterile Supplies policy read, its purpose was to provide guidance on checking expiration dates to ensure that sterile supplies were taken out of circulation by the expiration date. Sterile items will be checked before use to ensure that they have not expired. Appropriately dispose of sterile items that have reached the expiration date. The Storage of Supplies policy read, supplies must be rotated first in-first out (FIFO) to ensure products maintain quality and do not expire. Appropriately dispose of items that have reached the expiration date. References: According to the Baxter Dianeal Peritoneal Dialysis Solution package insert, exposure of pharmaceutical products to heat should be minimized. It is recommended the product be stored at room temperature (77°F), although brief exposure up to 104°F does not adversely affect the product. According to the Delflex Dextrose Peritoneal Dialysis Solution for Intraperitoneal Dialysis package insert, the solution is to be stored at 68°F to 77°F; excursions permitted between 59°F and 86°F. Brief exposure to temperatures up to 104°F may be tolerated provided the mean temperature does not exceed 77°F; however, such exposure should be minimized. According to the Core Curriculum for Nephrology Nursing Volume II, Seventh edition, provided by the facility, PD fluids should be warmed only to body temperature and shortly before use. When PD fluid is exposed to high temperatures during storage, the concentration of cytotoxic (cell-killing) glucose degradation products (GDP) increases rapidly and doubles within a few hours. This can also occur with prolonged warming of dialysis solutions and can happen regardless of the warming method used. The concentration levels and cytotoxicity of GPDs gradually decrease when the PD temperature is lowered to room temperature but the process is slow and takes up to 40 days. 1. The facility failed to ensure peritoneal dialysis fluids were stored in accordance with the manufacturer’s instruction for use (IFU) and in such a manner as to ensure their integrity and promote safe patient care. A. Observations i. Observations of the home training area on 4/15/24 at 10:13 a.m. revealed three bags of Baxter Dianeal Low Calcium Peritoneal Dialysis Solution with 2.5% Dextrose on a fluid warmer. One of the bags had a handwritten date of 3/29/24 (17 days prior to the date of observation) and the other two bags had a handwritten date of 4/12/24 (three days prior to the date of observation). An interview on 4/16/24 at 8:37 a.m. with the registered nurse (RN) manager of home therapies (RN Manager) #6 revealed the handwritten date on the bags of PD solutions was the date the bags were placed on the warmer. This observation of the PD solutions stored on the fluid warmer for three to 17 days was in contrast to the Baxter Dianeal Peritoneal Dialysis Solution package insert which read, exposure to heat was to be minimized and the product was to be stored at room temperature (77°F). This was also in contrast to the Core Curriculum for Nephrology Nursing book which read, PD fluids were warmed only to body temperature and shortly before use as high temperatures or prolonged warming of PD fluids during storage increased the concentration of cytotoxic (cell-killing) GDPs. B. Document review i. Upon request, the facility provided documents which revealed two letters written by the facility’s corporate group supporting the 45-day timeframe for their brand of PD fluids. a. A letter dated 4/17/18, written by the facility’s Medical Information and Communication group, read that the corporate group manufactured Delflex PD solutions. The letter also read Delflex PD solutions could be pre-warmed as high as 104°F for up to 45 days without affecting product stability. b. A letter dated 8/29/06, written by the facility’s corporate PD Product Manager, read that Deflex solutions could be placed on a warmer for up to 45 days. This documentation provided by the facility’s corporate group which supported the 45-day timeframe for Delflex PD solutions was in contrast to the observations of the home therapy room which revealed three bags of Baxter PD solutions stored on the fluid warmer. Also, this review was in contrast to the package insert for Baxter Dianeal Peritoneal Dialysis Solutions which read, the product was to be stored at room temperature (77°F) with minimal exposure to heat. This review was additionally in contrast to the package insert for Delflex Dextrose Peritoneal Dialysis Solution for Intraperitoneal Dialysis which read, the solution was to be stored at 68°F to 77°F with brief and minimal exposure up to 104°F, provided the mean temperature did not exceed 77°F. C. Interviews i. On 4/16/24 at 8:37 a.m., an interview was conducted with the RN manager of home therapies (RN Manager) #6. RN Manager #6 stated peritoneal dialysis fluids were kept on the warmer for up to 45 days by home therapy staff per facility policy. They stated they were unaware of the origins of this timeframe but felt this guidance was acceptable. RN Manager #6 stated this practice of continuously warming PD fluids for up to 45 days was safe for patient use when the fluids were kept in a temperature-controlled environment. This statement was in contrast to the Core Curriculum for Nephrology Nursing which read, PD fluids were warmed to body temperature shortly before use as PD fluids exposed to high temperatures or prolonged warming during storage rapidly increased the concentration of cytotoxic GDPs. RN Manager #6 stated staff discarded the PD fluids after 45 days on the warmer as any additional time created a risk comparable to using expired supplies on a patient. ii. On 4/17/24 at 10:08 a.m. an interview was conducted with medical director (Medical Director) #1. Medical Director #1 stated PD fluids were warmed before patient use as this practice made peritoneal dialysis more comfortable. They stated PD fluids were not normally kept on the warmer, which was in contrast to observations made in the home therapy room. Medical Director #1 stated they were not aware of the 45-day timeframe for warmed fluids as directed in the facility policy although they also stated they reviewed and updated PD policies annually. Medical Director #1 stated warmed PD fluids caused a slight increase in glucose degradation products (GDPs), however, this practice posed only a small risk to the patients as the patients received only one bag of these pre-warmed fluids during their PD training. They stated they did not know of any data showing harm to the patient due to this facility practice. However, Medical Director #1 stated the best practice was to store PD fluids at room temperature. 2. The facility failed to ensure expired medical supplies were discarded and not available for patient use. A. Observations i. On 4/15/24 at 2:15 p.m., observations of a white cabinet labeled “lines and dialyzers only”, located on the patient treatment floor, revealed four F250NR Optiflux dialyzers, expired on 11/30/23. ii. On 4/16/24 at 11:25 a.m., additional observations of the same white cabinet on the treatment floor revealed the expired dialyzers were still located in the cabinet. Furthermore, additional unexpired F200NR Optiflux dialyzers had been added to the supply cabinet adjacent to the expired F250NR dialyzers. The observations were in contrast to the Storage of Supplies policy and the Expiration Dates Sterile Supplies policy which read, staff were to dispose of items that had reached their expiration date. B. Interviews i. On 4/15/24 at 1:45 p.m., an interview was conducted with patient care technician (PCT) #12. PCT #12 stated the supplies stored in the white cabinet located on the patient treatment floor labeled “lines and dialyzers only” were used for patient treatments. PCT #12 said the F250NR dialyzers were not to be used anymore and pointed to a yellow sticky note in the cabinet which read, do not open dialyzer 250 anymore. PCT #12 stated they were unaware the dialyzers had expired 11/30/23. Further, PCT #12 said they were unsure why the F250NR dialyzers were located in that storage cabinet on the treatment floor adjacent to other dialyzers available for patient use. ii. On 4/17/24 at 8:15 a.m., an interview was conducted with registered nurse (RN) #13. RN #13 stated there were risks associated with using an expired dialyzer. They said the fibers could become fragile over time and create a risk of a blood leak which could get to the patient and cause harm. Further, RN #13 stated the harm could have included ruptured red blood vessels which could have caused the patient to die. Additionally, RN #13 said the facility no longer used the F250NR dialyzers and was not sure why they were located on the patient treatment floor. Furthermore, they said the F250NR dialyzers should not have been located on the patient treatment 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: 45020 Based on observations, interviews, and document review, the facility failed to ensure expired medications were removed and not available for patient use in one of one patient evacuation supply kits. Findings include: Facility policy: The Expiration Dates Sterile Supplies policy read, this policy provides guidance on checking expiration dates to assure the sterile supplies are taken out of circulation by the expiration date. Sterile items will be checked before use to ensure that they have not expired. Appropriately dispose of sterile items that have reached the expiration date. Documentation of expiration dates of sterile supplies contained in emergency boxes or code carts should be noted and logged as per facility protocol. The Storage of Supplies policy read, proper storage conditions are necessary to provide a safe environment and to ensure supplies are not expired, contaminated or damaged. Supplies must be rotated to ensure products maintain quality and do not expire. Dispose of items that have reached the expiration date. 1. The facility failed to ensure expired medical supplies were discarded and not available for patient use. a. On 4/16/24 at 10:10 a.m., an observation of the patient evacuation supply kit located on the patient treatment floor revealed one of six vials of heparin (a medication used to prevent blood clots) expired on 1/1/24. b. On 4/17/24 at 8:15 a.m., an interview was conducted with registered nurse (RN) #13. RN #13 stated the evacuation kit was checked once a month, which included checking the expiration dates of supplies and medications. RN #13 stated heparin was kept in the evacuation kit to be used for patients who had catheters (tubing that allows access to a major vein) to keep blood from clotting. RN #13 stated the risk of using expired heparin was the medication could lose potency. c. On 4/17/24 at 10:53 a.m., an interview was conducted with RN #3. RN #3 stated they checked the evacuation kit monthly, which included checking the supplies and medications for expiration dates and ensured all items were in place. RN #3 stated heparin was in the evacuation kit to be used for patients with a catheter in place. RN #3 stated if the heparin was expired it was not to be used on a patient because it might not be as effective.”

“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: 27438 Based on record reviews, interview, and policy review, the facility failed to follow the individualized dialysis (an artificial means of kidney function that removes the waste and excess fluid from the blood by passing through a filter) prescription as determined by the medical provider for four of eight in-center patients (Patient (P)1, P2, P4, and P5). Failure to follow the medical providers’ dialysis prescription had the potential to negatively impact the effectiveness of the prescribed dialysis treatments for all 93 patients receiving in-center dialysis treatments at this facility. Findings include: 1. Review of P1’s “Treatment Summary” forms, found in the electronic medical record (EMR), revealed two of six printed “Treatment Data” forms from 04/03/24 through 04/15/24, indicated the following: a. On 04/10/24, the staff failed to follow the dialysis prescription Dialysis Flow Rate (DFR) of 800 milliliters per minute (ml/min) when during the 4.0-hour treatment the DFR remained at 600 ml/min. There was no documented rationale for the change to the prescribed DFR. b. On 04/15/24, the staff failed to follow the dialysis prescription (ordered 04/12/24) DFR of 800 ml/min when during the 4-hour treatment the DFR remained at 600 ml/min. There was no documented rationale for the change to the prescribed DFR. 2. Review of P2’s “Treatment Summary” forms, found in the EMR, revealed one of six printed “Treatment Data” forms from 04/03/24 through 04/15/24, indicated the following: a. On 04/08/24, the staff failed to follow the dialysis prescription DFR of 600 ml/min when during the 4-hour treatment the DFR remained at 500 ml/min. There was no documented rationale for the change to the prescribed DFR. 3. Review of P4’s “Treatment Summary” forms, found in the EMR, revealed four of six printed “Treatment Data” forms from 03/26/24 through 04/13/24, indicated the following: a. On 03/26/24, the staff failed to follow the dialysis prescription DFR of 800 ml/min when during the 4.0-hour treatment the DFR remained at 600 ml/min. There was no documented rationale for the change to the prescribed DFR. b. On 04/02/24, the staff failed to follow the dialysis prescription DFR of 800 ml/min when during the 4-hour treatment the DFR remained at 600 ml/min. There was no documented rationale for the change to the prescribed DFR. c. On 04/04/24, the staff failed to follow the dialysis prescription DFR of 800 ml/min when during the 4-hour treatment the DFR remained at 600 ml/min. There was no documented rationale for the change to the prescribed DFR. d. On 04/06/24, the staff failed to follow the dialysis prescription DFR of 800 ml/min when during the 4-hour treatment the DFR remained at 600 ml/min. There was no documented rationale for the change to the prescribed DFR. 4. Review of P5’s “Treatment Details Report” forms, found in the EMR, revealed one of six printed “Treatment Data” forms from 03/22/24 through 04/12/24, indicated the following: a. On 04/01/24, the staff failed to follow the dialysis prescription DFR of 600 ml/min when during the 3.5-hour treatment the DFR remained at 500 ml/min for 2.5 hrs. There was no documented rationale for the change to the prescribed DFR. During an interview on 04/16/24 at 3:30 PM, Charge Nurse reviewed the DFR findings for P1, P2, P4, and P5 and verified the discrepancy between the prescription and the machine generated DFR documentation. The Charge Nurse verified staff are required to monitor observations of the machine settings every 30 minutes. During an interview on 04/17/24 at 8:30 AM, the Registered Nurse (RN)13 reviewed his/her observations for P4 on 04/02/24 at 2:04 PM. RN13 verified the DFR documented on the “Treatment Data” form as different than the prescription during the observation, however he/she failed to change or document during the patient treatment on why the DFR is different than the prescription. During an interview on 04/17/24 at 10:00 AM, the Medical Director revealed that he/she expects all treatment prescriptions for patients to be followed or have documentation on why the prescription was not followed. Review of the facility’s policy titled, “Patient Assessment and Monitoring,” revised 05/01/23, indicated, “Document machine parameters and safety checks every 30 minutes or more often as needed...check dialysis flow rate setting is correct, and the prescribed flow is being delivered.””