Fmc Mccalla

“Dialysis Emergency Equipment CFR(s): §494.62(b)(9) Condition for Coverage: [(b) Policies and procedures. The dialysis facility must develop and implement emergency preparedness policies and procedures, based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, and the communication plan at paragraph (c) of this section. The policies and procedures must be reviewed and updated at least every 2 years. At a minimum, the policies and procedures must address the following:] (9) A process by which the staff can confirm that emergency equipment, including, but not limited to, oxygen, airways, suction, defibrillator or automated external defibrillator, artificial resuscitator, and emergency drugs, are on the premises at all times and immediately available. This Standard is not met as evidenced by: 49603 Based on observation, and staff interview, it was determined the facility failed to ensure emergency supplies and medications on the Emergency Cart were ready for immediate use and not expired. This deficient practice had the potential to negatively affect all 46 patients dialyzing at this facility. Findings include: Facility Policy: Clinical Services, Storage of Supplies Version: 2 Published: 04/05/2021 Purpose: This policy is to provide guidelines for storage and handling of supplies. ... Background: Proper storage conditions are necessary to provide a safe environment and to ensure supplies are not expired, contaminated or damaged. ... Policy: ...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. Facility Policy: Clinical Services, Sequestering Medications Version: 1 Published: 09/26/2018 ... Background: Medications are expired... may pose a significant health and safety risk to patients and need to be sequestered. ... Sequestering Medications: Upon identifying a medication to be sequestered the following steps will need to be completed. 1. Complete the “Do Not Use Tag”... 2. Visibly affix the completed “Do Not Use” tag to the sequestered medications... 3. Place the sequestered medications in a clear plastic bag with the visibly affixed tag. 4. Place sequestered medication in a secure location as directed. 1. An observation of the Emergency Cart and contents was conducted on 12/4/23 at 10:30 AM. The following supplies and medications were found in the Emergency Cart ready for immediate patient use and expired: Two Adult CPR (Cardiopulmonary Resuscitation) stat padz Defibrillator pads with expiration dates: 10/16/23 and 5/28/23. Nine 10 % (percent) Calcium Chloride Injections 1000 mg/ 10 ml (milligrams/milliliters) with expiration date 10/10/23. An interview was conducted on 12/4/23 at 1:10 PM with Employee Identifier (EI) # 1, Director of Operations, who confirmed staff had failed to ensure all Emergency Cart supplies and medications were ready for immediate patient use and not expired.”

“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: 28327 Based on observations, facility policy and interviews, it was determined the facility failed to ensure staff completed vascular access care according to facility policy. This did affect Patient Identifier (PI) # 6, one of two patients observed for Access of AV (arteriovenous) Fistula or Graft for Initiation of Dialysis. Findings include: Facility Policy: Access Assessment and Cannulation Published: 7/5/22 Version: 3 Purpose: The purpose of this procedure is to provide guidance for ...placement of needles in an AV Fistula or AV Graft... Background: Before each treatment...The access must be prepared properly for needle placement to prevent bacteria from entering the bloodstream through the skin... Assessment of Vascular Access: 1. Prior to treatment, ask patient to wash access area with soap per hand hygiene procedure, Wash access ... if patients unable to clean their access. Skin Disinfection: 1. Disinfect cannulation sites as follows using any of the disinfectants below: 70 % (percent) alcohol pad: Using gentle friction, clean the access site ...and allow to dry before cannulating ... 1. During an observation of care on 12/4/23 at 9:46 AM at station 3, the surveyor observed Employee Identifier (EI) # 3, Patient Care Technician (PCT) assist PI # 6 into the treatment area. PI # 6 did not wash his/her access with soap. EI # 3 failed to clean PI # 6’s access with soap prior to performing antisepsis of the cannulation sites per facility policy. When performing antisepsis to both sites EI # 3 failed to allow the alcohol to dry prior to accessing the cannulation sites per facility policy. An interview was conducted on 12/6/23 at 11:30 AM with EI # 1, Director of Operations, who confirmed the staff failed to follow the facility policy for completion of vascular access care.”

“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: 28327 Based on observations, review of the facility policies, and staff interviews, it was determined the facility failed to ensure: 1. Staff performed hand hygiene after removing gloves per facility policy for an unsampled patient, and one of two observations conducted for Central Venous Catheter (CVC) Exit Site Care, including Patient Identifier (PI) # 12. 2. Staff followed the facility policy for assessment and cannulation of an AVF/AVG (arteriovenous fistula/graft) in one of two observations conducted for access of an AVF/AVG during initiation of dialysis, including PI # 6. 3. Patients performed hand hygiene after holding exit sites prior to exiting the clinic in two of two observations for discontinuation of dialysis and post dialysis access care for AVF/AVG, including PI # 8 and PI # 9. This had the potential to negatively affect all 46 patients who dialyze at the facility, staff, and visitors. Findings include: Facility Policy: Hand Hygiene Published: 11/6/23 Version: 8 Purpose: The purpose of this policy is to prevent transmission of pathogenic microorganisms to patients and staff through cross contamination. Responsibility All staff, patients...must follow the same requirements for hand hygiene. Policy: Hand hygiene includes either washing hands with soap and water or using a waterless alcohol-based antiseptic hand rub with 60-90% alcohol content... ...below identifies when hands should be washed specifically with soap and water or when alcohol-based hand rubs can be used: ...Immediately after removing gloves... Hand Hygiene: Patients Patients should perform hand hygiene if able, prior to and after each dialysis treatment. ...Gloves must be provided to patients when performing procedures which risk exposure to blood or body fluids, such as...holding access sites post treatment to achieve hemostasis. To help ensure the prevention of cross contamination to their family members or other patients, hand hygiene must be performed. Facility Policy: Access Assessment and Cannulation Published: 7/5/22 Version: 3 ...Background...The access must be prepared properly for needle placement to prevent bacteria from entering the bloodstream through the skin... Assessment of Vascular Access Follow the steps below... 5. LOOK... 6. Listen... 7. Feel... 9. Remove gloves and perform hand hygiene. Don new gloves. 1. During the flash tour on 12/4/23 at 8:50 AM Employee Identifier (EI) 2, Registered Nurse (RN) verified the prescription of an unsampled patient at station 6. After touching the dialysis machine, EI # 2 removed his/her gloves without performing hand hygiene. An interview was conducted on 12/6/23 at 11:30 AM with EI # 1, Director of Operations (DOO), who confirmed the staff should have performed hand hygiene after removing gloves. 2. An observation of care was conducted on 12/4/23 at 9:46 AM with EI # 3, Patient Care Technician (PCT), at station 3 for the access of AVF/AVG for the initiation of dialysis on PI # 6. With gloves on, EI # 3 evaluated PI # 6’s AVF/AVG sites with a stethoscope and palpation. EI # 3 applied antiseptic using two alcohol pads to the cannulation sites and inserted the cannulation needles without first changing gloves and performing hand hygiene. An interview was conducted on 12/6/23 at 11:30 AM with EI # 1, who confirmed per policy staff must change gloves and perform hand hygiene after access evaluation. EI # 1 confirmed EI # 3 failed to follow facility policy. 3. An observation of care was conducted on 12/4/23 at 10:05 AM with EI # 3 to discontinue dialysis of an AVF/AVG at station 1 on PI # 8. After holding pressure to both cannulation sites with a gloved hand, PI # 8 removed his/her glove and proceeded to exit the treatment floor at approximately 10:30 AM without performing hand hygiene per facility policy. An interview was conducted on12/6/23 at 11:30 AM with EI # 1 who confirmed staff failed to ensure the patient performed hand hygiene after removing gloves per facility policy. 4. An observation of care was conducted on 12/4/23 at 10:55 AM with EI # 3 to discontinue dialysis of an AVF/AVG at station 2 on PI # 9. After holding pressure to both cannulation sites with a gloved hand, PI # 9 removed his/her glove and proceeded to exit the treatment floor at approximately 11:25 AM without performing hand hygiene per facility policy. An interview was conducted on12/6/23 at 11:30 AM with EI # 1 who confirmed staff failed to ensure the patient performed hand hygiene after removing gloves per facility policy. 5. An observation of care was conducted on 12/4/23 at 12:05 PM with EI # 2 at station 10 for CVC exit site care on PI # 12. EI # 2 entered station 10 and applied gloves. EI # 2 began setting up CVC supplies and removed his/her gloves and re-applied gloves without performing hand hygiene per facility policy. EI # 2 cleansed the CVC exit site, removed his/her gloves and without performing hand hygiene proceeded to the supply cabinet and retrieved cleaned supplies. An interview was conducted on 12/6/23 at 11:30 AM with EI # 1 who confirmed the staff failed to perform hand hygiene per facility policy.”

“IC-GOWNS, SHIELDS/MASKS-NO STAFF EAT/DRINK CFR(s): 494.30(a)(1)(i) Staff members should wear gowns, face shields, eye wear, or masks to protect themselves and prevent soiling of clothing when performing procedures during which spurting or spattering of blood might occur (e.g., during initiation and termination of dialysis, cleaning of dialyzers, and centrifugation of blood). Staff members should not eat, drink, or smoke in the dialysis treatment area or in the laboratory. This Standard is not met as evidenced by: 28327 Based on observation, review of facility policy and interview, it was determined the facility failed to ensure staff removed all PPE (personal protective equipment) when exiting the patient treatment area. This had the potential to affect the 46 patients treated at the facility, staff, and visitors. Findings include: Facility Policy: Personal Protective Equipment Published: 11/06/23 Version: 6 ...All personal protective equipment shall be removed prior to leaving the treatment area... 1. An observation was conducted on 12/4/23 at 9:00 AM with Employee Identifier (EI) # 5 CCHT (Certified Clinical Hemodialysis Technician), who was observed exiting the treatment floor, into the supply/water room to perform a total chlorine water test. EI # 5 failed to remove his/her gown prior to exiting the treatment area per the facility policy. An interview was conducted on 12/6/23 at 11:30 AM with EI # 1, Director of Operations. EI # 1 verified the staff failed to follow the facility policy for PPE.”

“IC-IF TO STATION=DISP/DEDICATE OR DISINFECT CFR(s): 494.30(a)(1)(i) Items taken into the dialysis station should either be disposed of, dedicated for use only on a single patient, or cleaned and disinfected before being taken to a common clean area or used on another patient. -- Nondisposable items that cannot be cleaned and disinfected (e.g., adhesive tape, cloth covered blood pressure cuffs) should be dedicated for use only on a single patient. -- Unused medications (including multiple dose vials containing diluents) or supplies (syringes, alcohol swabs, etc.) taken to the patient’s station should be used only for that patient and should not be returned to a common clean area or used on other patients. This Standard is not met as evidenced by: 28327 Based on observations, review of facility policy and interview, it was determined the facility failed to ensure the staff cleaned and disinfected non-disposable equipment (Myron L D-6 Meter) after use. This did affect one of three observations of preparation of the hemodialysis (HD) machine prior to treatment initiation and had the potential to negatively affect all 46 patients who dialyze at the facility. Findings Include: Facility Policy: Cleaning and Disinfection of the Dialysis Station Published: 09/05/2023 Version: 14 Purpose The purpose of this policy is to provide guidelines to prevent the spread of infectious disease in accordance with appropriate regulations, and to maintain a clean, safe, and aesthetically pleasant environment for patients, staff, and visitors. Responsibility All dialysis facility staff... General Cleaning ... After use, any non-disposable equipment and supplies brought into the dialysis station... must be disinfected with 1:100 bleach or EPA (Environmental Protection Agency) registered disinfectant before being removed from the dialysis station. An observation was conducted on 12/4/23 at 10:02 AM with Employee Identifier (EI) # 3, Patient Care Technician, to observe the preparation of the HD machine for an unsampled patient, at station 6. During the observation, EI # 3 obtained a dialysate sample from the HD machine at station 6 and obtained the conductivity and pH (the acidity or alkalinity of a substance) reading from the Myron L D-6 meter. After the reading was obtained, EI # 3 left station 6 and proceeded to the dirty sink area and emptied the dialysate sample in the sink. EI # 6 failed to clean and disinfect the Myron L D-6 meter prior to leaving the dialysis station per the facility policy. An interview was conducted on 12/6/23 at 11:30 AM with Employee Identifier (EI) # 1, Director of Operations (DOO), who confirmed EI # 3 failed to follow the facility policy for cleaning and disinfecting non-disposable equipment after use.”

“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: 28327 Based on observations, review of facility policy and procedure, and interviews, it was determined the facility failed to ensure staff cleaned and disinfected the dialysis station after patient treatments and prior to setting up clean supplies on the hemodialysis machine for the next patient. This affected two of two observations of the cleaning and disinfection of the dialysis station and had the potential to affect all 46 patients dialyzing at this facility. Findings include: Facility Policy: Facility Policy: Cleaning and Disinfection of the Dialysis Station Published: 09/05/2023 Version: 14 Purpose The purpose of this policy is to provide guidelines to prevent the spread of infectious disease in accordance with appropriate regulations, and to maintain a clean, safe, and aesthetically pleasant environment for patients, staff, and visitors. Responsibility All dialysis facility staff ... Background The Centers for Medicare and Medicaid Services (CMS) has regulations that in order to prevent contamination, a dialysis station must be cleaned and disinfected between dialysis patients. The chair and dialysis equipment are used by multiple patients during a treatment day and it is critical that these items be thoroughly cleaned and disinfected between uses. Definition Dialysis Station: Area including the dialysis machine, chair/bed and other reusable equipment or supplies utilized during dialysis treatment... Equipment in the dialysis station may include... the following: Dialysis machine ... B/P (blood pressure) cuff... Chair/bed Individual television and remote General Cleaning The dialysis station could become contaminated with blood and other body fluids during treatment... Cleaning of the Dialysis Machine Externally disinfect the dialysis machine with 1:100 bleach solutions after each dialysis treatment. Work Surface Cleaning and Disinfection without Visible Blood using Bleach Solutions All work surfaces shall be cleaned and disinfected with 1:100 bleach solution after completion of procedures. Make the surface glistening wet and let air dry unless otherwise specified by the manufacturer. Vacating the Machine For patients dialyzing in a treatment area where multiple patients dialyze ... before the dialysis machine can be... set up for the next treatment. ...Procedure Follow the steps below to disinfect the dialysis station after each dialysis treatment: Step: ...3. Use a cloth wetted with 1:100 bleach solution... to clean and disinfect the dialysis station (chair/bed, tables, machine, television... B/P cuff, hand sanitizer dispenser and holder, chaise wall behind chair... 4. Clean all surfaces... 1. An observation was conducted on 12/4/23 at 9:20 AM to observe Employee Identifier (EI) # 4, Certified Clinical Hemodialysis Technician (CCHT), perform cleaning and disinfection of station 6. EI # 4 first cleaned the dialysis machine and failed to clean and disinfect the wire basket on the side of the machine. EI # 4 then began cleaning and disinfection of the TV (television) remote and B/P cuff and then placed the TV remote and B/P cuff in the dirty wire basket on the side of the dialysis machine. EI # 4 then proceeded to clean and disinfect the dialysis chair and failed to clean and disinfect underneath the chairside tabletops bilaterally. Further observations revealed EI # 4 failed to clean and disinfect the countertop behind the dialysis station. An interview was conducted on 12/6/23 at 11:30 AM with EI # 1, Director of Operations (DOO), who confirmed the staff failed to follow the facility policy for cleaning and disinfection of the dialysis station. 2. An observation was conducted on 12/4/223 at 9:30 AM to observe EI # 3, Patient Care Technician (PCT), perform cleaning and disinfection of station 3. EI # 3 first cleaned and disinfected the top and computer screen of the dialysis machine. EI # 3 then retrieved clean supplies and began preparation of the hemodialysis (HD) machine for the next patient. EI # 3 failed to clean and disinfect the side surfaces, wire basket with TV remote, arterial and venous chambers, Hansen connectors, dialysate hoses, and the bottom of the dialysis machine. EI # 3 failed to clean and disinfect the dialysis station prior to setting the machine up for the next patient. EI # 3 then began cleaning and disinfection of the dialysis chair and failed to clean and disinfect underneath the chairside tabletops bilaterally. Further observations revealed EI # 3 failed to clean and disinfect the countertop behind the dialysis station. An interview was conducted on 12/6/23 at 11:30 AM with EI # 1 who confirmed the staff should not begin preparation of the HD machine until the entire station had been cleaned and disinfected. EI # 1 further confirmed the staff failed to follow the facility policy for cleaning and disinfection of the dialysis station.”

“IC-ASEPTIC TECHNIQUES FOR IV MEDS CFR(s): 494.30(b)(2) [The facility must-] (2) Ensure that clinical staff demonstrate compliance with current aseptic techniques when dispensing and administering intravenous medications from vials and ampules; and This Standard is not met as evidenced by: 28327 Based on observation, review of facility policy, and interview, it was determined the facility failed to ensure staff administered Intravenous (IV) Venofer (Iron Sucrose, which is indicated for the treatment of Iron Deficiency Anemia) per facility policy. This did affect one of one patient observed for the administration of IV Venofer including Patient Identifier (PI) # 10 and had the potential to negatively affect all patients dialyzing and receiving Venofer at this facility. Findings include: Facility Policy: Medication Preparation and Administration Published: 02/06/2023 Version: 6 Purpose: To administer medications with the goals of staff and patient safety, optimal therapeutic response, and infection control. ...Allowable IV Medication Administration Sites: The sites for IV administration listed below are the Allowable IV Medication Administration Sites... Iron: Route of Administration: IV Push: Saline Line Needle Injection Port, Saline Line Luer Lock med (medication) port, and Venous Drip Chamber Med Pigtail Line. An observation of care was conducted on 12/4/23 at 11:40 AM with Employee Identifier (EI) # 2, Registered Nurse (RN) to administer IV Venofer at station 10 to PI # 10. EI # 2 cleansed the Arterial Drip Chamber Med Pigtail Line with an alcohol pad and administered the IV Venofer in the Arterial Drip Chamber Med Pigtail Line. EI # 2 failed to administer the IV Venofer in an allowable IV med administration site per the facility policy. An interview was conducted on 12/6/23 at 11:30 AM with EI # 1, Director of Operations, who confirmed the Arterial Drip Chamber Med Pigtail Line was not an allowable IV med administration site for IV Venofer. EI # 1 confirmed EI # 2 failed to follow the facility policy for IV administration of Venofer.”

“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: 28327 Based on observations, facility procedure, and interview, it was determined the facility failed to ensure staff disinfected the CVC (Central Venous Catheter) threads and hubs according to facility procedure. This affected two of two observations during discontinuation of dialysis with a CVC including Patient Identifier (PI) # 1, PI # 12 and one of one observation during initiation of dialysis with a CVC including PI # 12 and had the potential to negatively affect all patients dialyzing with CVC’s. Facility Procedure: Initiation of Treatment Using a CVC and Optiflux Single Use Ebeam Dialyzer Published: 7/6/21 Version: 7 Purpose: The purpose of this procedure is to provide direction initiating hemodialysis treatment using a CVC... Preparing the Catheter: Disinfection of the Catheter Connections... Follow the steps below to disinfect the catheter connections: Threads and end of the luer lock (hub) must be scrubbed with 70 % (percent) sterile alcohol pad... for 10-15 seconds and any time caps are removed ... (i.e.{that is} end of treatment...) to reduce risk of contamination. 1. During observations of care on 12/4/23 at 10:20 AM, the surveyor observed Employee Identifier (EI) # 2, RN (Registered Nurse) discontinue dialysis with a CVC for PI # 1 at station 9. During the procedure, EI # 2 removed the two exterior caps, used an alcohol pad on each hub to clean the hub sides and threads for 4 to 5 seconds, making 5 to 6 twists around the hub sides and threads with each alcohol pad. EI # 2 failed to scrub the hub sides and threads thoroughly with friction for 10-15 seconds, per facility procedure. 2. During observations of care on 12/4/23 at 12:05 PM, the surveyor observed EI # 2, initiate dialysis with a CVC for PI # 12 at station 10. During the procedure, EI # 2 removed the two exterior caps, used an alcohol pad on each hub to clean the hub sides and threads for 7 to 8 seconds, making 7 to 8 twists around the hub sides and threads. EI # 2 failed to scrub the hub sides and threads thoroughly with friction for 10-15 seconds, per procedure. 3. During observations of care on 12/4/23 at 3:26 PM, the surveyor observed EI # 2, discontinue dialysis with a CVC for PI # 12 at station 10. During the procedure, EI # 2 removed the two exterior caps, used an alcohol pad on each hub to clean the hub sides and threads for 8 seconds, making 6 to 7 twists around the hub sides and threads. EI # 2 failed to scrub the hub sides and threads thoroughly with friction for 10-15 seconds, per procedure. An interview was conducted on 12/6/23 at 11:30 AM with EI # 1, Director of Operations, who confirmed the staff must scrub each hub for 10-15 seconds, per procedure and the staff failed to follow the facility procedure for CVC hub disinfection.”

“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: 28327 Based on observation, facility policy and interview, it was determined the facility failed to secure and restrict access to the water treatment room. This had the potential to negatively affect all 46 patients who dialyzed at the facility. Findings include: Facility Policy: Physical Security and Facility Access Published: 09/05/2023 Version: 3 Purpose: To ensure a secure and safe environment ... Water Treatment Area Security: Restricted access must be maintained to prevent unwanted tampering with the water treatment equipment. The facility must be maintained to prevent unwanted entry by outside persons not involved in the daily operation of the clinic. This is accomplished by: Locking all doors that allow access to the water treatment equipment. During observations of care on 12/4/23 at 9:00 AM the surveyor observed the door to the supply room which lead into the water room was open. Upon further observation, the water room door was also open. At 11:43 AM both the supply room door and water room door remained open. An interview was conducted on 12/4/23 at 12:15 PM with Employee Identifier # 1, Director of Operations, who confirmed the door to the supply room and water room should be closed and locked at all times and EI # 1 proceeded to close the door to the supply room.”

“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: 28327 Based on observations, facility policy and procedure, manufacturer’s instructions for use for the Myron L D-6 Meter, and interviews, it was determined the facility failed to ensure staff: 1. Rinsed the Myron L D-6 Meter with clean water after dialysate testing. 2. Followed the facility policy and tested the dialysate pH (the acidity or alkalinity of a substance) when a bath acid concentration was changed. 3. Followed the facility policy for obtaining a sample of dialysate when performing the conductivity and pH of final dialysate prior to each patient’s treatment. This affected two of three observations of preparation of the hemodialysis (HD) machine prior to treatment initiation and had the potential to negatively affect all 46 patients who dialyze at the facility. Findings include: Facility Policy: Checking Conductivity and pH of Final Dialysate Published: 04/11/2022 Version: 9 Purpose: The purpose of this policy is to provide guidelines to verify final dialysate conductivity and pH prior to initiating hemodialysis treatments and during treatments if required. Policy: The final dialysate conductivity and pH must be tested prior to each patient’s treatment. Dialysate pH must be tested when changing acid concentrate formulations (example 1 K {potassium} to 2K) ... Dialysate sample must be obtained in a cup ... DO NOT connect any meter to the sample ports on the dialysis machine. Facility Policy: Myron L D6 Measuring Procedures Published: 06/14/2017 Version: 7 General Warnings and Precautions: ...Caution: when measuring only Conductivity ... the pH sensor well cap should be sealed. Any crystals or other contamination around the cap must be rinsed to prevent contamination of the sample ... Refill pH sensor well with pH sensor storage solution when not in use. Measuring Dialysate Conductivity and pH ...2. ...Note: Checking machine conductivity and pH with an independent meter prior to each patient treatment is a regulatory requirement and is important for the safety of the dialysis treatment. ...8. ...(Do NOT take the D6 meter to the dialysis machine) ... Myron L Company Digital Dialysate Meter Operation Manual 18 February 16 page 11 ...V1. After Using the Dialysate Meter A. Maintenance of the Conductivity Cell Rinse out the conductivity cell with clean water... 1. An observation was conducted on 12/4/23 at 10:02 AM with Employee Identifier (EI) # 3, Patient Care Technician, to observe the preparation of the HD machine for an unsampled patient, at station 6. During the observation, EI # 3 obtained a dialysate sample from the HD machine at station 6 and obtained the conductivity and pH reading from the Myron L D-6 meter. After the reading was obtained, EI # 3 left station 6 and proceeded to the dirty sink area and emptied the dialysate sample in the sink. EI # 3 failed to rinse the conductivity cell with clean water. EI # 3 failed to follow the facility policy for obtaining the sample in a cup and not taking the Myron L D-6 meter to the dialysis machine. An interview was conducted on 12/6/23 at 11:30 AM with Employee Identifier (EI) # 1, Director of Operations (DOO), who confirmed EI # 3 failed to follow the manufacturer’s instructions for use Myron L D-6 Meter for rinsing the conductivity cell with clean water after use. EI # 1 also confirmed EI # 3 failed to follow the facility policy when obtaining a sample of dialysate when performing the conductivity and pH of final dialysate. 2. An observation was conducted on 12/4/23 at 11:35 AM with EI # 4, CCHT (Certified Clinical Hemodialysis Technician), to observe the preparation of the HD machine for an unsampled patient, at station 9. EI # 4 set the dialysis machine up with a wall bath ( 2.0 K 2.5 Ca {Calcium}) and tested the conductivity and pH. EI # 4 then proceeded to retrieve a jug bath which was 2K 2.0 Ca and connected the jug bath to the dialysis machine. EI # 4 failed to test the dialysate pH after changing the acid concentrate per facility policy. An interview was conducted 12/6/23 at 11:30 AM with EI # 1 who confirmed the staff failed to follow the facility policy for testing the dialysate pH after changing the acid concentrate.”

“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: 28327 Based on review of medical records (MR), facility policies and procedures, and interviews with the staff, it was determined the facility failed to ensure: 1. Normal Saline (NS) used for prime and post treatment rinse was documented. 2. Blood pressure (BP), pulse rate and safety checks were performed and documented every 30 minutes or more as needed but not to exceed 45 minutes. This deficient practice affected two of five hemodialysis records reviewed and did affect Patient Identifier (PI) # 3, PI # 5 and had the potential to negatively affect all 46 patients dialyzing at this facility. Findings include: Facility Policy: Initiation of Treatment Using a Central Venous Catheter (CVC) and Optiflux Single Use Ebeam Dialyzer Published: 7/6/21 Version: 7 Purpose: The purpose of this procedure is to provide direction initiating hemodialysis treatment using a CVC... Prior to Initiation: Assessment and Machine Parameters Step ...6. Add any fluid to be given during the treatment such as saline prime/rinse back... Documentation Document... all required patient and machine data in the patient’s hemodialysis treatment sheet... Facility Policy: Patient Assessment and Monitoring Published: 5/1/23 Version: 4 During Treatment Obtain BP and pulse rate every 30 minutes or more as needed but not to exceed 45 minutes... 1. PI # 3 was admitted to the facility on 9/11/23 with a primary diagnosis of End Stage Renal Disease (ESRD). Review of the MR revealed PI # 3 was dialyzing with a CVC. Review of the Treatment Sheet (TS) dated 11/19/23 revealed a BP, pulse, and safety check documented at 11:44 AM. The next BP, pulse, and safety check was documented at 12:36 PM, which was 51 minutes later. Further review of the TS dated 11/19/23 revealed there was no documentation of the NS used for the rinse back at the end of the treatment. An interview was conducted on 12/6/23 at 11:16 AM with Employee Identifier (EI) # 1, Director of Operations (DOO), who confirmed staff failed to document the amount of NS given as rinse back, and failed to document BP, pulse, and safety checks within the timeframe per policy. 2. PI # 5 was admitted to the facility on 10/12/23 with a primary diagnosis of ESRD. Review of the MR revealed PI # 5 was dialyzing with a CVC. Review of the TS’s dated 11/20/23, 11/28/23 and 11/30/23 revealed there was no documentation of the NS used for the rinse back at the end of the treatments. Review of the TS dated 12/2/23 revealed a BP, pulse, and safety check documented at 6:30 AM. The next BP, pulse, and safety check was documented at 7:30 AM, which was 60 minutes later. An interview was conducted on 12/6/23 at 11:16 AM with EI # 1 who confirmed staff failed to document the amount of NS given as rinse back, and failed to document BP, pulse, and safety checks within the timeframe per policy.”

“POC-ACHIEVE ADEQUATE CLEARANCE CFR(s): 494.90(a)(1) Achieve and sustain the prescribed dose of dialysis to meet a hemodialysis Kt/V of at least 1.2 and a peritoneal dialysis weekly Kt/V of at least 1.7 or meet an alternative equivalent professionally-accepted clinical practice standard for adequacy of dialysis. This Standard is not met as evidenced by: 28327 Based on medical record review, facility policy, and interviews with staff it was determined the facility failed to ensure treatments were administered per physician prescription for Blood Flow Rate (BFR) and Dialysate Flow Rate (DFR). This affected four of five incenter dialysis patients including Patient Identifier (PI) # 1, PI # 3, PI # 4, PI # 5 and had the potential to affect all 46 patients admitted to this facility. Findings include: Facility Policy: Patient Assessment and Monitoring Published: 05/01/2023 Version: 4 ...3. Machine Parameters and Extracorporeal Circuit Check machine settings and measurements: Check prescribed blood flow rate is being achieved or reason is documented in medical record if unable to meet prescribed blood flow rate. Check dialysate flow rate setting is correct, and the prescribed flow is being delivered... 1. PI # 1 was admitted to the facility on 9/4/23 with a primary diagnosis of End Stage Renal Disease (ESRD). Review of the Orders Summary Report (OSR) revealed hemodialysis treatment orders dated 11/27/23 with a BFR of 350 and DFR of 500. Review of the Treatment Sheet (TS) dated 11/27/23 revealed the BFR was initiated at 400 at 6:18 AM then decreased to 375 at 8:32 AM. There was no reason documented why the BFR was 400 and 375 and not at 350 as ordered. Further review of the TS dated 11/27/23 revealed the DFR ran the entire treatment from 6:18 AM to 10:04 AM at 800. There was no reason documented why the DFR was 800 and not at 500 as ordered. Review of the TS dated 11/29/23 revealed the DFR ran the entire treatment from 5:53 AM to 9:43 AM at 800. There was no reason documented why the DFR was 800 and not at 500 as ordered. An interview was conducted on 12/6/23 with Employee Identifier (EI) # 1, Director of Operations (DOO), who confirmed the staff failed to document why the BFR was not at the 350 ordered rate and DFR 500 ordered rate. 2. PI # 3 was admitted to the facility on 9/11/23 with a primary diagnosis of ESRD. Review of the Hemodialysis Orders for 11/19/23, 11/24/23 and 11/27/23 revealed a BFR of 350 and DFR of 500. Review of the TS dated 11/19/23 revealed the BFR was ran at 340 from 11:44 AM to 12:36 PM and the DFR was increased to 800 from 12:36 PM to 3:31 PM. There was no reason documented why the BFR was 340 and not at 350 as ordered and the DFR was 800 and not 500 as ordered. Review of the TS dated 11/24/23 revealed the BFR was decreased to 300 at 12:38 PM and then increased to 325 at 3:34 PM. There was no reason documented why the BFR was 300 and 325 and not at 350 as ordered. Further review of the TS dated 11/24/23 revealed the DFR ran the entire treatment from 11:59 AM to 3:49 PM at 800. There was no reason documented why the DFR was 800 and not at 500 as ordered. Review of the TS dated 11/27/23 revealed the DRF ran at 800 from 3:01 PM to 4:23 PM. There was no reason documented why the DFR was 800 and not at 500 as ordered. An interview was conducted on 12/6/23 at 11:16 AM with EI # 1 who confirmed the staff failed to document why the BFR was not at the 350 ordered rate and DFR 500 ordered rate. 3. PI # 4 was admitted to the facility on 1/10/22 with a primary diagnosis of ESRD. Review of the OSR revealed hemodialysis treatment orders dated 11/14/23 with a DFR of 500. Review of the TS dated 11/20/23 revealed the DFR ran the entire treatment from 6:08 AM to 9:49 AM at 800. There was no reason documented why the DFR was 800 and not at 500 as ordered. Review of the TS dated 11/28/23 revealed the DFR was increased to 800 from 7:36 AM to 9:52 AM. There was no reason documented why the DFR was 800 and not at 500 as ordered. An interview was conducted on 12/6/23 at 11:15 AM with EI # 1 who confirmed the staff failed to document why the DFR was not at the 500 ordered rate. 4. PI # 5 was admitted to the facility on 10/12/23 with a primary diagnosis of ESRD. Review of the OSR revealed hemodialysis treatment orders dated 10/19/23 with a BFR of 350. Review of the TS dated 11/22/23 revealed the BFR initiated at 400 at 12:17 PM then decreased to 300 from 12:35 PM to 4:16 PM. There was no reason documented why the BFR was 400 and 300 and not at 350 as ordered. Review of the TS dated 11/28/23 revealed the BFR ran the entire treatment from 12:05 PM to 3:36 PM at 400. There was no reason documented why the BFR was 400 and not at 350 as ordered. An interview was conducted on 12/6/23 at 11:07 AM with EI # 1 who confirmed the staff failed to document why the BFR was not at the 350 ordered rate.”

“MD RESP-ENSURE ALL ADHERE TO P&P CFR(s): 494.150(c)(2)(i) The medical director must- (2) Ensure that- (i) All policies and procedures relative to patient admissions, patient care, infection control, and safety are adhered to by all individuals who treat patients in the facility, including attending physicians and nonphysician providers; This Standard is not met as evidenced by: 28327 Based on review of medical records (MR), facility policy and interview, it was determined the Medical Director failed to ensure the Registered Nurse (RN) followed the facility policy and performed and documented a nurse assessment evaluation prior to the first dialysis treatment in two of two new patient records reviewed. This affected Patient Identifier (PI) # 1, PI # 3 and had the potential to affect all new patients admitted to this facility. Findings include: Facility Policy: Comprehensive Interdisciplinary Assessment (CIA) and Plan of Care (POC) Published: 07/03/23 Version: 6 Purpose ...to provide guidance on the requirements for the CIA and the patient POC. Prior to Initiation of the Patients Fist Treatment for Patients New to Dialysis: A RN must perform an assessment on patients NEW to dialysis BEFORE initiation of their first treatment to determine immediate needs. The RN must document the assessment...in Chairside or multidisciplinary notes... 1. PI # 1 was admitted to the facility on 9/4/23 with a primary diagnosis of End Stage Renal Disease (ESRD). Review of the 9/4/23 Treatment Sheet documentation revealed the initial facility dialysis treatment was initiated at 11:56 AM and the nurse evaluation was documented at 12:53 PM which was 57 minutes later. An interview was conducted on 12/6/23 at 11:13 AM with Employee Identifier (EI) # 1, Director of Operations, who confirmed staff failed to document initial RN assessment findings prior to the initial dialysis treatment initiation. 2. PI # 3 was admitted to the facility on 9/11/23 with a primary diagnosis of ESRD. Review of the 9/11/23 Treatment Sheet documentation revealed the initial facility dialysis treatment was initiated at 12:04 PM and the nurse evaluation was documented at 12:19 PM which was 15 minutes later. An interview was conducted on 12/6/23 at 11:16 AM, EI # 1 who confirmed staff failed to document initial RN assessment findings prior to the initial dialysis treatment initiation.”