062538 Grand Junction Dialysis (Dci)

“CFC-MEDICAL RECORDS CFR(s): 494.170 This Condition is not met as evidenced by: 50313 Based on the manner and degree of the standard level deficiencies referenced to the Condition, it was determined the Condition of Participation §494.170 Medical Records, was out of compliance. V727 - Standard: Protection of the patient’s record. The dialysis facility must- (1) Safeguard patient records against loss, destruction, or unauthorized use; and (2) Keep confidential all information contained in the patient’s record, except when release is authorized pursuant to one of the following: (i) The transfer of the patient to another facility. (ii) Certain exceptions provided for in the law. (iii) Provisions allowed under third party payment contracts. (iv) Approval by the patient. (v) Inspection by authorized agents of the Secretary, as required for the administration of the dialysis program. Based on observations, interviews, and document review, the facility failed to ensure medical records in the medical record room were stored securely to prevent unauthorized access.”

“MR-PROTECT PT RECORDS FM LOSS/CONFIDENTIAL CFR(s): 494.170(a) The dialysis facility must- (1)Safeguard patient records against loss, destruction, or unauthorized use; and (2) Keep confidential all information contained in the patient’s record, except when release is authorized pursuant to one of the following: (i) The transfer of the patient to another facility. (ii) Certain exceptions provided for in the law. (iii) Provisions allowed under third party payment contracts. (iv) Approval by the patient. (v) Inspection by authorized agents of the Secretary, as required for the administration of the dialysis program. This Standard is not met as evidenced by: 50313 Based on observations, interviews, and document review, the facility failed to ensure medical records in the medical record room were stored securely to prevent unauthorized access. Findings include: Facility policies: According to the Filing of Active and Closed Records policy, the medical record is a legal document and by law must be protected. The contents of medical records shall remain confidential and records should be secured and not accessible to casual viewing. According to the Patient Rights & Responsibilities policy, patients have the right to privacy and confidentiality regarding their treatment and medical information. 1. The facility failed to ensure the medical records of patients receiving dialysis (the process of filtering the blood using a machine) were stored in such a manner as to prevent unauthorized access. A. Observations i. Observations conducted of the medical record room on 2/5/24 from 1:58 p.m. to 3:03 p.m. revealed the door to the medical room door was open and unmonitored. Observations revealed the filing cabinets in the medical record room were also open and unmonitored and patient names were clearly visible on the outside of the binders containing the medical records. This was in contrast to the Filing of Active and Closed Records policy which read, the medical record was to be protected. The contents of medical records remained confidential and records were secured and not accessible to casual viewing. This was also in contrast to the Patient Rights & Responsibilities policy which read, patients had the right to privacy and confidentiality regarding their treatment and medical information. B. Medical record review i. A review of the medical records stored in the medical record room revealed patient names, demographic information, insurance information, social security numbers, medical diagnoses, and medical treatments. C. Interviews i. An interview was conducted on 2/5/24 at 2:13 p.m. with administrative assistant (Assistant) #1. Assistant #1 stated they were working in the medical record room and the door was left open for easier access. They stated they would be aware if patients attempted to gain access to the medical record room. Assistant #1 stated the risk of not securing medical records was unauthorized access to health information. This interview was in contrast to observations which revealed the door to the administrative area, where Assistant #1 was located at times during the observation, was closed with no visibility to the hallway or the medical record room. In addition, the observation revealed the medical record room could not be directly visualized from where Assistant #1 was sitting in the administrative area. ii. An interview was conducted on 2/5/24 at 2:30 p.m. with nurse manager (Manager) #2. Manager #2 stated medical records were always secured in a locked cabinet inside of a locked room. They stated the risk of unsecured medical records was a Health Insurance Portability and Accountability Act (HIPAA) (a federal law to protect sensitive patient health information from being disclosed without consent) violation. This was in contrast to the observation of the medical record room door being open. iii. An interview was conducted on 2/5/24 at 3:29 p.m. with operations director (Director) #3. Director #3 stated the medical record room contained the medical records of dialysis patients. They stated that the door to the medical record room was open while Assistant #1 was assisting the providers. Director #3 stated the door to the medical room was always locked at the end of the day. They stated there was a risk when medical records were unsecured.”

“CFC-INFECTION CONTROL CFR(s): 494.30 This Condition is not met as evidenced by: 47962 Based on the manner and degree of the standard level deficiency referenced to the Condition, it was determined the Condition §494.30 Infection Control, was out of compliance. V113 - The dialysis facility must demonstrate that it follows standard infection control precautions by ensuring staff wear disposable gloves when caring for the patient or touching the patient ’ s equipment at the dialysis station. Based on observations, interviews, and document review, the facility failed to ensure standard procedures for infection control were followed in observations conducted during one of three days for patients who presented to the facility for hemodialysis (filtering the blood using a machine and a filter). V122 - The facility must ensure cleaning and disinfection of contaminated surfaces, medical devices, and equipment. Based on observations, interviews, and document review, the facility failed to ensure standard procedures for infection control were followed in one of one observation of patient medical equipment and supplies stored in cabinets around the nursing station. Specifically, the facility failed to ensure single-use medical equipment, nasal cannulas (tubing used to deliver supplemental oxygen), was not reused for subsequent patient care. Additionally, the facility failed to ensure patient care staff cleaned and disinfected patient treatment chairs per national guidelines and manufacturer’s instructions for use (IFU) in five of five observations of dialysis station cleaning. V146 - The facility must demonstrate that it follows the “Guidelines for the Prevention of Intravascular Catheter-Related Infections.” 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 four of ten observations of staff accessing AVFs and CVCs.Additionally, the facility failed to ensure standard procedures for infection control were followed in observations conducted during one of three days for patients who presented to the facility for hemodialysis (filtering the blood using a machine and a filter).”

“CFC-PHYSICAL ENVIRONMENT CFR(s): 494.60 This Condition is not met as evidenced by: 47962 Based on the manner and degree of the standard level deficiency referenced to the Condition, it was determined the Condition §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, document reviews, and interviews, the facility failed to ensure expired medications were removed and not available for patient use in one of one patient treatment rooms. V403 Standard: Equipment maintenance. 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 reviews, the facility failed to ensure the emergency code cart (cart containing emergency supplies and medications) was kept secure to prevent unauthorized access. Also, the facility failed to ensure the glucometer test strips were labeled with the opened date, and glucose control solutions were discarded after the manufacturer’s expiration date. Additionally, the facility failed to ensure medical supplies had not expired and were unavailable for patient use in four (medication administration area, lab area, patient treatment floor, and evacuation cart) of the five supply storage areas observed. V407 Patients must be in view of staff during hemodialysis treatment to ensure patient safety, (video surveillance will not meet this requirement). Based on observations, interviews, and document reviews, the facility failed to ensure patient safety during hemodialysis (filtering of the blood using a machine and a filter) treatment. Specifically, the facility failed to ensure patient access sites for dialysis treatments remained visible for 1 of 12 patients observed receiving treatments (Station #12).”

“CFC-PATIENT ASSESSMENT CFR(s): 494.80 This Condition is not met as evidenced by: 47962 Based on the manner and degree of the standard level deficiencies referenced to the Condition, it was determined the Condition of Participation §494.80 Patient Assessment, was out of compliance. V504-Blood pressure and fluid management needs. Based on interviews and document review, the facility failed to ensure staff monitored and reported changes in patients’ blood pressure, heart rate, and overall condition and documented communication to nursing staff and providers before, during, and after dialysis (the process of filtering a patient’s blood using a machine and filter) treatment based on facility policy. This failure was observed in one of twelve patients receiving dialysis and in two of six medical records reviewed (Patient #3 and Patient #4).”

“CFC-QAPI CFR(s): 494.110 This Condition is not met as evidenced by: 47962 Based on the manner and degree of the standard level deficiency referenced to the Condition, it was determined the Condition §494.110 Quality Assessment and Performance Improvement was out of compliance. V639 Standard: Prioritizing improvement activities. The dialysis facility must set priorities for performance improvement, considering prevalence and severity of identified problems and giving priority to improvement activities that affect clinical outcomes or patient safety. Based on interviews and document review, the facility failed to ensure quality assessment and performance improvement (QAPI) identified problems, considered the prevalence and severity of identified problems, and gave priority to improvement activities that affected patient safety.”

“CFC-GOVERNANCE CFR(s): 494.180 This Condition is not met as evidenced by: 48269 Based on the manner and degree of the standard level deficiency referenced to the Condition, it was determined the Condition §494.180 Governance, was out of compliance. V763 - Ensures that all medical staff who provide care in the facility are informed of all facility policies and procedures, including the facility’s quality assessment and performance improvement program. Communicate expectations to the medical staff regarding staff participation in improving the quality of medical care provided to facility patients. Based on observations, interviews, and document reviews, the facility failed to ensure policies were comprehensive, updated, and easily accessible to staff. Also, the facility failed to ensure the medical staff met regularly and maintained written records of their meetings. Additionally, the facility failed to ensure the medical staff bylaws were current.”

“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 one 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 Universal Precautions in the Dialysis Setting policy, the purpose is to provide a standardized approach to infection control as recommended by the Centers for Disease Control (CDC) to decrease the transmission of bloodborne pathogens through parenteral, mucous membrane, and non-intact skin exposures. Gloves are required when performing invasive procedures on the patient or the extracorporeal system during the hemodialysis treatment. Required when touching blood, body fluids, mucous membranes, non-intact skin, items soiled with blood or other body fluid, and blood or body fluid specimen containers. Are to be used only once, changed between patients, and discarded as biohazard waste. Are to be changed after contamination. Hand sanitizing is required after glove removal. According to the Central Venous Catheter (CVC) (tubing that allows access to a major vein) Preparation for Dialysis policy, issued 7/11/17, the disconnection from dialysis with catheter process is as follows. Scrub the extension tubes, Y connector, and exterior of catheter connections with an Exsept soaked 4x4 for 15 seconds. Discard this gauze and drop the connection onto a second 4x4 soaked with antimicrobial. Remove gloves, hand sanitize, and put on clean gloves. Discontinue dialysis and attach sterile NS flushes to both lumens. Flush blood out of both ports and clamp immediately. Apply sterile caps. Tape for security. Reference: According to the CDC Recommendations for Preventing Transmission of Infections Among Chronic Hemodialysis Patients, Infection Control Precautions for all patients, published 4/27/01, 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. To facilitate glove use, a supply of clean nonsterile gloves and a glove discard container should be placed near each dialysis station. 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. 1. The facility failed to ensure staff changed gloves and performed hand hygiene according to facility policy and national guidelines when they engaged in patient care. A. Observations i. On 12/4/23 at 3:07 p.m., an observation was conducted of a central venous catheter (CVC) (tubing that allows access to a major vein) discontinuation at station #3. Patient care technician (PCT) #5 scrubbed the arterial hub for 13 seconds with an alcohol pad then flushed the lumen with a syringe containing normal saline. PCT #5 scrubbed the venous hub for 10 seconds with an alcohol pad then flushed the lumen with a syringe of normal saline. This observation did not reveal glove changes or hand hygiene performed during the CVC discontinuation after the PCT scrubbed the tubing, connector, and catheter connections with an antimicrobial agent. This observation was in contrast to the CVC Preparation for Dialysis which read, the process for disconnection from dialysis with a catheter was as follows. The extension tubes, Y connector, and exterior of catheter connections were scrubbed for 15 seconds with a 4x4 soaked in Exsept. This gauze was discarded and the connection was placed onto a second 4x4 soaked with antimicrobial. Gloves were removed, hands were sanitized, and new clean gloves were worn. ii. On 12/6/23 at 10:59 a.m., PCT #5 was observed touching the patient’s blankets with gloved hands during the dialysis treatment, then the footrest of the chair upon which the patient rested visibly dirty shoes. PCT #5 then immediately touched the bloodlines and the dialysis machine without removing the soiled gloves and performing hand hygiene. iii. On 12/6/23 at 11:01 a.m., PCT #6 was observed touching the footrest of the chair with gloved hands during the dialysis treatment, after which she touched the dialysis machine and then the bloodlines without removing the soiled gloves and performing hand hygiene. iv. On 12/6/23 at 10:23 a.m., PCT #4 was observed touching a patient’s blankets with gloved hands, then immediately afterward touching the dialysis machine without removing the soiled gloves and performing hand hygiene. These observations were in contrast to the Universal Precautions in the Dialysis Setting policy, which read gloves were to be used only once and changed after contamination. Hand sanitizing was required after glove removal. These observations were also in contrast to the CDC Recommendations for Preventing Transmission of Infections Among Chronic Hemodialysis Patients which read, during the process of hemodialysis, hands were always washed after gloves were removed, as well as after touching blood, body fluids, secretions, excretions, and contaminated items. If hands were not visibly soiled, the use of a waterless antiseptic hand rub could be substituted for hand washing. B. Interviews i. On 12/6/23 at 2:34 p.m., an interview was conducted with PCT #2. PCT #2 stated following proper hand hygiene practices was important as all surfaces were assumed to be dirty. She stated not following policy created an infection risk to the patient, which could progress to the patient’s death. ii. On 12/6/23 at 3:13 p.m., an interview was conducted with registered nurse (RN) #9. RN #9 stated hand hygiene was important to prevent the spread of infectious organisms which could cause infections in the patients. iii. On 12/7/23 at 8:54 a.m., an interview was conducted with RN Manager #8. RN Manager #8 stated the facility followed CDC guidelines for hand hygiene. She stated when moving from dirty to clean areas, staff were to remove their gloves, sanitize their hands, and then put on new gloves before resuming patient care. iv. On 12/7/23 at 8:02 a.m., an interview was conducted with operations director (Director) #3. Director #3 stated it was important to follow facility policy for hand hygiene as there was otherwise a risk of cross-contamination which could negatively impact the patients. v. On 12/05/2023 at 2:52 p.m., an interview was conducted with medical director (Director) #7. Director #7 stated staff were expected to follow infection control policies to prevent patient infections.”

“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, interviews, and document review, the facility failed to ensure standard procedures for infection control were followed in one of one observation of patient medical equipment and supplies stored in cabinets around the nursing station. Specifically, the facility failed to ensure single-use medical equipment, nasal cannulas (tubing used to deliver supplemental oxygen), was not reused for subsequent patient care. Additionally, the facility failed to ensure patient care staff cleaned and disinfected patient treatment chairs per national guidelines and manufacturer’s instructions for use (IFU) in five of five observations of dialysis station cleaning. Findings include: Facility Policies: According to the Universal Precautions in the Dialysis Setting policy, the purpose is to provide a standardized approach to infection control as recommended by Centers for Disease Control (CDC) to decrease the transmission of bloodborne pathogens through parenteral, mucous membrane, and non-intact skin exposures. According to the Surface Disinfection Dilution of Bleach policy, its purpose is to provide the correct steps for mixing bleach solutions at acceptable dilution ratios to meet CDC recommendations for surface disinfection, infection control, and prevent damage to sensitive medical equipment. The 1:100 bleach solution will be used for normal surface disinfection of all medical equipment, chairs, countertops, blood pressure cuffs, remotes, TV controls, and other surfaces that the patient and/or the staff might come in contact with during normal use. According to the Surface Cleaning in the Dialysis Setting policy, its purpose is to establish a standardized procedure for cleaning the outside of the dialysis machine, chair, and ancillary equipment after the completion of dialysis to prevent the transmission of organisms between patients and personnel. The chair cleaning procedure read, wipe the chair thoroughly with 1:100 bleach solution. Place the chair in Trendelenburg. Wipe off the arms, footrest, and chair lever used to raise the footrest thoroughly. These areas have increased patient contact. References: According to the instructions for use (IFU) for the Hudson RCI Adult Nasal Cannula with seven-foot star lumen tubing, do not reuse. According to the Pure Bright Germicidal Ultra Bleach instructions for use, for sanitizing work surfaces: cover the surface with bleach solution for at least two minutes, and let air dry. According to the Centers for Disease Control (CDC) Recommendations for Preventing Transmission of Infections Among Chronic Hemodialysis Patients, Cleaning and Disinfection, retrieved from https://www.cdc.gov/mmwr/preview/mmwrhtml/rr5005a1.htm, if the manufacturer has provided instructions on sterilization or disinfection of the item, these instructions should be followed. After each patient treatment, clean environmental surfaces at the dialysis station, including the dialysis bed or chair, countertops, and external surfaces of the dialysis machine, including containers associated with the prime waste. Use any soap, detergent, or detergent germicide. For each chemical sterilant and disinfectant, follow the manufacturer’s instructions regarding use, including appropriate dilution and contact time. The Infection Control Precautions for All Patients read, any item taken to a patient’s dialysis station could become contaminated with blood and other body fluids and serve as a vehicle of transmission to other patients either directly or by contamination of the hands of personnel. Additional measures to prevent contamination of clean or sterile items include not handling or storing contaminated (i.e., used) supplies or equipment, in areas where clean (i.e., unused) equipment and supplies are handled. 1. The facility failed to ensure single-use medical equipment, specifically nasal cannulas, were not reused according to IFU and national guidelines. A. Observations i. On 12/4/23 at 2:55 p.m. an observation conducted of the cabinets around the nursing station revealed three nasal cannulas taken out of their original packaging, each repackaged individually in a plastic bag, labeled only with a patient name. This observation was in contrast to the IFU for the Hudson RCI Adult Nasal Cannula with seven-foot star lumen tubing which read, the nasal cannula was not to be reused. This observation was also in contrast to the CDC Recommendations for Preventing Transmission of Infections Among Chronic Hemodialysis Patients, Cleaning and Disinfection which read, if the manufacturer provided instructions on sterilization or disinfection of the item, these instructions were to be followed. Additionally, Infection Control Precautions for All Patients read, any item taken to a patient’s dialysis station could become contaminated with blood and other body fluids and serve as a vehicle of transmission to other patients either directly or by contamination of the hands of personnel. Additional measures to prevent contamination of clean or sterile items included not handling or storing contaminated (i.e., used) supplies or equipment in areas where clean (i.e., unused) equipment and supplies were handled. B. Interviews i. On 12/4/23 at 3:59 p.m., an interview was conducted with patient care technician (PCT) #2. PCT #2 stated the facility reused nasal cannulas to save money. She stated the nasal cannulas were labeled with patients’ names to ensure they were used for the same patient in the future. PCT #2 stated nasal cannulas functioned the same when re-used but there was a risk of infections when the nasal cannulas were moved. ii. On 12/5/23 at 11:22 a.m., an interview was conducted with infection control and registered nurse manager (RN Manager) #1. RN Manager #1 stated the facility did reuse nasal cannulas. She stated the risk of reusing nasal cannulas included bacterial infections, possibly leading to pneumonia. iii. On 12/4/23 at 4:15 p.m., an interview was conducted with operations director (Director) #3. Director #3 stated nasal cannulas were reused. She stated the bags containing the nasal cannulas were dated and the cannulas were changed out once per week. This interview was in contrast to the observation which did not reveal dates written on the packaging of any previously used nasal cannulas. iv. On 12/5/23 at 2:52 p.m., an interview was conducted with medical director (Director) #7. Director #7 stated nasal cannulas were reused to save money. He stated he did not see an issue with reusing nasal cannulas as long as they were used on the same patient. 2. The facility failed to ensure staff fully cleaned and allowed chairs to remain open until fully dry after cleaning. A. Observations of chair cleanings revealed staff did not clean all areas of the chair and did not allow the chairs to dry before the chairs were closed. Examples included: i. On 12/4/23 at 12:07 p.m., an observation revealed staff did not open both sides of the chair or recline the chair while cleaning the chair. Also, the one side of the chair that was opened to clean was closed while visibly wet. ii. On 12/4/23 at 2:59 p.m., an observation revealed staff wiped down the chair in station #4 and closed the chair while visibly wet. iii. On 12/4/23 at 3:04 p.m., an observation revealed staff wiped down the chair in station #12 and closed the chair while visibly wet. iv. On 12/4/23 at 3:45 p.m., an observation revealed staff wiped down the chair in station #3. Staff scrubbed the left wing two times and never opened or scrubbed the inside of the right wing. The chair was then closed while visibly wet. v. On 12/4/23 at 3:56 p.m., an observation revealed staff wiped down the chair in station #8 and closed the chair while visibly wet. These observations were in contrast to the Pure Bright Germicidal Ultra Bleach IFU which read, surfaces should have been covered with bleach solution for at least two minutes and allowed to air dry. These observations were also in contrast to the CDC Recommendations for Preventing Transmission of Infections Among Chronic Hemodialysis Patients, Cleaning and Disinfection which read, manufacturer’s instructions regarding use should have been followed when dialysis chairs were cleaned, which included the appropriate dilution and contact time. B. Interviews i. On 12/6/23 at 2:34 p.m., an interview was conducted with patient care technician (PCT) #2. PCT #2 stated that the bleach 1:100 solution was used to clean all surfaces of the chairs. They said it was important to disinfect the dialysis chairs following facility policy between patients because a patient might have something contagious that could spread to other patients. ii. On 12/5/23 at 11:22 a.m., an interview was conducted with registered nurse manager (RN Manager) #1. RN Manager #1 stated they were the designated infection control nurse. They said chair cleaning was performed by staff with the 1:100 bleach solution. They described the chair cleaning process to include laying the chair out flat with the sides opened. RN Manager #1 said staff should wipe down the entire surface of the chair. They said the dry time for the bleach solution was available at the nurse’s station for reference. Further, RN Manager #1 stated the risk to the patient of not following the disinfection process could be severe infection and possibly even sepsis and death. iii. On 12/5/23 at 2:51 p.m., an interview was conducted with the facility medical director (Director) #7. Director #7 stated chair cleaning included cleaning all surfaces of the chair and allowing the cleaning solution to dry. They said the importance of disinfecting the dialysis chairs was to prevent infections in patients. These interviews were in contrast to observations which revealed the chairs were not consistently cleaned on all surfaces and were closed when visibly wet.”

“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: 47962 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 four of ten observations of staff accessing AVFs and CVCs. Findings include: Facility policies: According to the Central Venous Catheter Preparation for Dialysis policy, issued 7/11/17, the procedure to initiate hemodialysis is as follows. Remove dirty dressing to assess the catheter site for any signs of infection. Change gloves. Place an open sterile ExSept saturated 4x4 under the catheter. Scrub the clamps and extension tubes and Y connector with ExSept thoroughly, approximately 15 seconds. Discard the 4x4 while keeping a second 4x4 to drop catheter ends on. Allow adequate exposure time and friction to remove microbial agents and ensure disinfection. Use only antimicrobial agents approved as exposing the catheter extension tubes to alcohol can damage the catheter. Change gloves. Remove and discard the arterial port cap. Scrub the hub. Aseptically attach the empty syringe to the arterial port. Unclamp and aspirate the contents of the arterial lumen. Reclamp. Check for clots in the syringe. Discard the syringe. Repeat these steps with the venous extension. Attach the pre-filled normal saline (NS) syringe and irrigate. Initiate dialysis using standard procedure. Dress the CVC site after cleaning with sterile gauze or other material. To disconnect the patient from dialysis with a catheter, scrub the extension tubes, Y connector, and exterior of catheter connections with ExSept soaked 4x4 for 15 seconds. Discard this gauze and drop the connection onto a second 4x4 soaked with antimicrobial. Remove gloves, hand sanitize, and put on clean gloves. Discontinue dialysis and attach sterile NS flushes to both lumens. Flush blood out of both ports and clamp immediately. Apply sterile caps. Tape for security. According to the Utilizing the CVC Catheter for Hemodialysis Treatment Initiation policy issued 3/10/15, positive patient outcomes are dependent on complication-free vascular access. Aseptic technique, prevention, and early treatment of CVC-related complications may greatly reduce associated morbidity, hospitalizations, and mortality in the hemodialysis patient. Procedure: Perform catheter disinfection per policy (see policy: Pre-Treatment Care and Disinfection of the CVC). Infection is the most common cause of complications, hospitalizations, and morbidity in a catheter patient. Disinfection of the CVC and exit sites prior to treatment initiation significantly reduces contaminants that may exist on the exit site and catheter itself, therefore reducing the possibility of infection for the patient. Ensure clamp on the arterial port is closed. Remove the cap from the arterial port of CVC, and attach a sterile 10 milliliter (mL) syringe to the port. Repeat on the venous port. Open clamp on the arterial port. Gently pull back on the arterial port syringe and aspirate five mL from the arterial port. Close clamp. Removes all indwelling lock solutions from prior treatment. Discard the syringe into the sharps container. Attach a saline-filled 10 mL syringe and gently flush the port with normal saline. Close clamp. Repeat on the venous port. Administer heparin loading dose if prescribed. Remove the syringe from the port. Attach bloodlines to ports. According to the Preparation and Cannulation (insertion of tubing into a vein) of the Fistula and Graft, last reviewed 3/5/23, use universal precautions as appropriate. Prepare the area for venipuncture (puncturing the skin with a needle) using a Prevantics swab. Use one Prevantics swab per site using back and forth motion for 15 seconds of contact and 30 seconds of dry time. Choose sites for needle insertion. For an AVF, place a tourniquet. Insert arterial needle. Tape in place. Aspirate for blood return. Release tourniquet. Repeat steps for venous needle insertion. According to the Vascular Access Disinfectant Policy, issued 2/14/23, the purpose is to provide a list of acceptable disinfectants for all vascular access care. Aseptic (free from contamination by bacteria and viruses) technique should be used when preparing a vascular access for cannulation. Bloodstream infections are a very dangerous and costly issue for hemodialysis patients. AVFs will be disinfected with one of the approved disinfectant regimens. All staff will adhere to contact and drying time per antiseptic. Staff will follow the recommended scrubbing motion, either a concentric circle or back and forth. Staff will use aseptic technique when cleansing a patient’s vascular access. Disinfectants used for vascular access (AVF and CVC). The primary disinfectant used by the facility is 70% Isopropyl Alcohol. If the patient is not tolerant, Chlorhexidine gluconate >2% with 70% Isopropyl Alcohol can be used as a second option. For the 70% Isopropyl Alcohol, three prep pads are used per site with a contact time of 60 seconds. There is no drying time. The pads are applied in an inner-to-outer circular motion. For the Chlorhexidine gluconate >2% solution with 70% isopropyl alcohol, one swab stick is used per site with a contact time of 30 seconds. The dry time is one minute or until completely dry. The swab stick is applied in a back-and-forth motion while applying gentle friction. Using alcohol pads: with clean, gloved hands, cleanse the cannulation site with a 70% alcohol pad. Start in the center of the cannulation site working from the inside outwards in a circular pattern. Repeat these steps with a minimum of three alcohol prep pads per site, for a total contact time of one minute. Repeat steps for the second cannulation site. Proceed with cannulation while the alcohol is wet. Using Chlorhexidine swabs: with clean gloved hands, disinfect cannulation sites. Apply disinfectant by using a gentle back-and-forth scrubbing motion for a total of 30 seconds. This back-and-forth motion creates friction and helps drive solution into crevices and lower layers, reaching more bacteria. Allow the area to dry completely. According to the Subclavian Catheter: Routine Care and Dressing Change policy issued 4/10/18, the purpose is to establish a standardized procedure for exit site care to prevent infection. Remove any crusts with ExSept. See policy “Venous Catheter Dressing and Care.” References: According to the Centers for Disease Control (CDC) Recommendations for Preventing Transmission of Infections Among Chronic Hemodialysis Patients, Cleaning and Disinfection, retrieved from https://www.cdc.gov/mmwr/preview/mmwrhtml/rr5005a1.htm, published 4/27/01, for each chemical sterilant and disinfectant, follow the manufacturer’s instructions regarding use, including appropriate dilution and contact time. According to the Disinfectant Solution guidelines posted at the nursing station, the contact time for Alcohol 70% is one minute in duration, using three pads per needle insertion site (for a total of 6 pads). There is not a dry time for Alcohol 70%. The contact time for Chloraprep (Chlorhexidine) is 30 seconds using one swabstick per site and the dry time is one minute. The contact time for ExSept Plus (Hypochlorite) is one minute using gauze pads and the dry time is two minutes. 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 12/6/23 at 11:43 a.m., an observation was conducted of a CVC initiation at station #10. Patient care technician (PCT) #5 cleaned the catheter limbs (tubing) and caps for 18 seconds with an alcohol pad. She scrubbed the venous hub for 10 seconds with an alcohol pad and connected a syringe. PCT #5 detached this syringe and then scrubbed the venous hub with alcohol for 12 seconds. She connected a syringe containing normal saline and flushed the lumen. PCT #5 detached this syringe and scrubbed the hub for 10 seconds with an alcohol pad. She connected a new syringe and aspirated blood from the catheter limbs. PCT #5 removed the arterial cap and scrubbed the arterial hub for 12 seconds. She attached a syringe containing normal saline and flushed the catheter limbs. PCT #5 then lightly wiped around the exit site (access) with a Chlorhexidine swab for seven seconds after which she immediately laid down a square of gauze and then three bandages to cover the exit site. PCT #5 did not allow for drying time before covering the exit site. This observation was in contrast to the CVC Preparation for Dialysis policy which read, the clamps, extension tubes (limbs) and Y connector were scrubbed with ExSept for approximately 15 seconds. The 4x4 was discarded while a second 4x4 was placed under the catheter ends. The gloves were changed. The arterial port cap was removed and discarded. The hub was scrubbed. An empty syringe was aseptically attached to the arterial port. The tubing was unclamped and the contents of the arterial lumen were aspirated. The tubing was reclamped. The syringe was discarded. These steps were repeated for the venous extension. A pre-filled normal saline syringe was attached and the lumen was irrigated. This observation was also in contrast to the Utilizing the CVC Catheter for Hemodialysis Treatment Initiation policy which read, the arterial cap was removed and a sterile 10 mL syringe was attached to the port. This was repeated on the venous port. The arterial clamp was opened. The syringe was pulled back and five mL was aspirated from the arterial port. The clamps were closed. The syringe was discarded. A saline-filled 10 mL syringe was attached and the port was flushed with normal saline. The clamp was closed. This process was repeated for the venous port. Heparin was administered if prescribed. This was additionally in contrast to the Vascular Access Disinfectant Policy which read, all staff adhered to contact and drying time per antiseptic. Staff followed the recommended scrubbing motion, either a concentric circle or back and forth. For the Chlorhexidine gluconate >2% solution with 70% isopropyl alcohol, one swab stick was used per site with a contact time of 30 seconds. The dry time was one minute or until completely dry. Further, this observation was in contrast to the CDC Recommendations for Preventing Transmission of Infections Among Chronic Hemodialysis Patients, Cleaning and Disinfection which read, for each chemical sterilant and disinfectant, the manufacturer’s instructions were followed regarding use, including appropriate dilution and contact time. ii. On 12/4/23 at 3:07 p.m., an observation was conducted of a CVC discontinuation at station #3. PCT #5 scrubbed the arterial hub for 13 seconds with an alcohol pad then flushed the lumen with a syringe containing normal saline. She detached the syringe and then scrubbed the hub for 10 seconds with an alcohol pad. PCT #5 then injected heparin into the lumen with a second syringe and detached the syringe. PCT #5 unscrewed the venous bloodline and scrubbed the venous hub for 10 seconds with an alcohol pad. She flushed the lumen with a syringe of normal saline then detached the syringe and scrubbed the hub for 12 seconds with an alcohol pad. PCT #5 injected heparin into the lumen then removed the syringe and scrubbed the hub for 13 seconds with an alcohol pad. During an interview conducted during this observation, PCT #5 stated the hubs were scrubbed with an alcohol pad for 25 seconds, which was in contrast with the observation of PCT #5 scrubbing the hubs for 10-12 seconds. Also, this observation did not reveal any glove changes or hand hygiene performed during the CVC discontinuation This observation and interview were in contrast to the CVC Preparation for Dialysis which read, disconnecting a patient from dialysis with a catheter involved the extension tubes (limbs), Y connector, and the exterior of the catheter connections were scrubbed for 15 seconds with a 4x4 soaked in ExSept. This gauze was discarded and the connection was placed onto a second 4x4 soaked with antimicrobial. Gloves were removed, hands were sanitized, and new clean gloves were worn. Dialysis was stopped and sterile NS flushes were performed to both lumens (inside the catheter limbs). This observation was also in contrast to the CDC Recommendations for Preventing Transmission of Infections Among Chronic Hemodialysis Patients, Cleaning and Disinfection which read, for each chemical sterilant and disinfectant, the manufacturer’s instructions were followed regarding use, including appropriate dilution and contact time. iii. On 12/6/23 at 11:33 a.m., an observation was conducted of an AVF initiation at station #12. PCT #6 scrubbed the AVF access site with one alcohol pad over both needle insertion sites for 26 seconds, then scrubbed with a second alcohol pad to the entire area for 26 seconds, and lastly, scrubbed with a third alcohol pad over the entire area for 16 seconds. PCT #6 used a total of three alcohol pads during this process. During an interview conducted during the time of the observation, PCT #6 stated alcohol swabs were used for 15 to 30 seconds over the AVF access. This observation and interview were in contrast to the Vascular Access Disinfectant Policy which read, all staff adhered to contact and drying time per antiseptic. Staff followed the recommended scrubbing motion, either a concentric circle or back and forth. With the 70% Isopropyl Alcohol, three prep pads were used per site with a contact time of 60 seconds. There was no drying time. With clean, gloved hands, the cannulation site was cleansed with a 70% alcohol pad starting in the center of the cannulation site and working from the inside outwards in a circular pattern. These steps were repeated with a minimum of three alcohol prep pads per site, for a total contact time of one minute. These steps were repeated for the second cannulation site. This observation was also in contrast to the CDC Recommendations for Preventing Transmission of Infections Among Chronic Hemodialysis Patients, Cleaning and Disinfection which read, for each chemical sterilant and disinfectant, the manufacturer’s instructions were followed regarding use, including appropriate dilution and contact time. iv. On 12/6/23 at 11:57 a.m., an observation was conducted of an AVF initiation at station #14. PCT #6 scrubbed the distal (further from the heart) AVF access site with one alcohol pad for 27 seconds then scrubbed the proximal (closer to the heart) AVF access site with a second alcohol pad for 33 seconds. PCT #6 used a total of two alcohol pads during this process. This observation was in contrast to the Vascular Access Disinfectant Policy which read, all staff adhered to contact and drying time per antiseptic. Staff followed the recommended scrubbing motion, either a concentric circle or back and forth. With the 70% Isopropyl Alcohol, three prep pads were used per site with a contact time of 60 seconds. There was no drying time. With clean, gloved hands, the cannulation site was cleansed with a 70% alcohol pad starting in the center of the cannulation site and working from the inside outwards in a circular pattern. These steps were repeated with a minimum of three alcohol prep pads per site, for a total contact time of one minute. These steps were repeated for the second cannulation site. This observation was also in contrast to the CDC Recommendations for Preventing Transmission of Infections Among Chronic Hemodialysis Patients, Cleaning and Disinfection which read, for each chemical sterilant and disinfectant, the manufacturer’s instructions were followed regarding use, including appropriate dilution and contact time. B. Interviews i. On 12/6/23 at 6:20 a.m., an interview was conducted with PCT #6. PCT #6 stated the AVF access was swabbed with an alcohol pad for 15-30 seconds. This interview was in contrast to the Vascular Access Disinfectant Policy which read, with the 70% Isopropyl Alcohol, three prep pads were used per site with a contact time of 60 seconds. The cannulation site was cleansed with a 70% alcohol pad starting in the center of the cannulation site and working from the inside outwards in a circular pattern. These steps were repeated with a minimum of three alcohol prep pads per site, for a total contact time of one minute. These steps were repeated for the second cannulation site. ii. On 12/6/23 at 2:34 p.m., an interview was conducted with PCT #2. PCT #2 stated her responsibilities included training the other PCTs in hemodialysis. She stated CVC caps and hubs were each scrubbed for 15 seconds with an alcohol pad. PCT #2 stated if policies and procedures for AVF and CVC initiations and discontinuations were not followed, patients were at risk of infection and if the patient had a CVC, an infection could quickly travel to their heart. PCT #2 also stated an infection could limit patients’ dialysis options as patients may not be able to obtain new accesses if their first access was impacted. This interview was in contrast to the Central Venous Catheter Preparation for Dialysis policy which read, only approved antimicrobial agents were used as exposing the catheter extension tubes to alcohol could damage the catheter. iii. On 12/6/23 at 3:13 p.m., an interview was conducted with registered nurse (RN) #9. RN #9 stated it was important to follow policy for AVF and CVC initiations and discontinuations for patient safety. She stated bloodborne pathogens (bacteria or viruses that can cause disease) could lead to infections in patients if staff did not follow facility policy. iv. On 12/5/23 at 11:22 a.m., an interview was conducted with the infection control and RN manager (RN Manager) #1. RN Manager #1 stated disinfecting the accesses, caps, and hubs according to policy was important or patients were at risk of bloodstream infections, sepsis (bloodstream infection), and potentially death.”

“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, document reviews, and interviews, the facility failed to ensure expired medications were removed and not available for patient use in one of one patient treatment rooms. Findings include: Facility policies: The Supply Management policy read, supplies are no longer safe to use once they have exceeded their manufacturer’s listed expiration date. Staff will check and discard any expired supplies in the appropriate receptacle monthly or as needed. Reference: The manufacturer’s instructions for use (IFU) for Fresenius Medical Care 0.9% sodium chloride injection (solution containing sodium chloride in water for injection intended for intravenous administration), USP 1000 ml, read, do not use after the expiration date on the package. 1. The facility failed to ensure expired medications were removed from the facility’s inventory and not available for use according to facility policy and manufacturer IFUs. A. On 12/5/23 at 11:05 a.m., an observation of the patient treatment area revealed four bags of 0.9% sodium chloride injection, USP 1000mL, were expired. Three bags expired on 11/30/21 and one bag expired on 5/31/22. This was in contrast to the Supply Management policy which read, supplies are no longer safe to use once they have exceeded their manufacturer’s listed expiration date. Further, it stated staff were to discard any expired supplies. This was also in contrast to the Fresenius Medical Care IFU for 0.9% sodium chloride injection USP 1000 ml which read, do not use after the expiration date on the package. B. Interviews i. On 12/6/23 at 2:34 p.m., an interview was conducted with patient care technician (PCT) #2. PCT #2 described the facility process for checking for outdated medications and medical supplies. They stated a PCT was assigned monthly to check medical supplies for inventory and expiration dates. They said the nurses checked the medications for inventory and expiration dates. PCT #2 stated the receptionist and biomedical technician inventoried and checked for monthly expiration dates in the back storage room. ii. On 12/5/23 at 11:22 a.m., an interview was conducted with RN Manager #1. RN Manager #1 stated it was the PCT’s responsibility to check for expired medical supplies throughout the facility and in the lab. They said if a medication or medical supply was expired it should not have been used. RN Manager #1 explained if an expired medication was used on a patient, it could have harmed the patient. Additionally, they stated medications that were expired were not good for patients. iii. On 12/5/23 at 2:51 p.m., an interview was conducted with medical director (Director) #7. Director #7 stated in general, expired medications and medical supplies should not have been used on patients. They said staff were supposed to complete routine checks, identify expired medications, and remove them to ensure they were not available for patient use. Director #7 stated the importance of ensuring expired medications and medical supplies were not available for patient use was to prevent infections in patients.”

“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: 48269 Based on observations, interviews, and document reviews, the facility failed to ensure the emergency code cart (cart containing emergency supplies and medications) was kept secure to prevent unauthorized access. Also, the facility failed to ensure the glucometer test strips were labeled with the opened date, and glucose control solutions were discarded after the manufacturer’s expiration date. Additionally, the facility failed to ensure medical supplies had not expired and were unavailable for patient use in four (medication administration area, lab area, patient treatment floor, and evacuation cart) of the five supply storage areas observed. Findings include: Facility policies: The General Administration of Medication policy read, all medications will be secured by lock and key and accessed only by applicable staff. The Glucose Testing Quality Control Program policy read, reagent strips and quality control materials will be dated when opened and discarded after a specified period of time. The Supply Management policy read, rotating supplies as they come into a facility is considered best practice to mitigate waste. Also, supplies are no longer safe to use once they have exceeded their manufacturer’s listed expiration date. Staff will check and discard any expired supplies in the appropriate receptacle monthly or as needed. References: The manufacturer’s instructions for use (IFU) for Assure Platinum Blood Glucose Monitoring System read, when you first open the vial of test strips, write the date on the vial label. Use the test strips within three months of first opening the vial. Do not use test strips beyond the expiration date on the label. The manufacturer’s instructions for use for Assure Dose Control Solutions read, use before the expiration date printed on the bottle. 1. The facility failed to ensure medications and supplies in the code cart were kept secure from unauthorized access to prevent serious harm or risk including tampering or stealing medications, diversion (illegal distribution or abuse of prescription drugs or their use for unintended purposes), or unauthorized use of medications and supplies stored in the cart. A. Observations i. On 12/5/23 at 8:55 a.m., an observation of the code cart located on the patient treatment floor revealed the facility did not keep the code cart locked. The code cart had a locking mechanism but it was not locked. Staff, patients, and visitors were observed in the area where the code cart was located. The cart contained medications for use in a medical emergency. The medications observed were epinephrine (known as adrenaline and used to treat many life-threatening conditions), bicarbonate (a crucial biochemical in the body’s pH buffering system), Solu-Medrol (a steroid used to treat inflammation and severe allergies), and Heparin (medication used to prevent blood clots). This was in contrast to the general administration of medication policy which read, all medications would be secured by lock and key and accessed only by applicable staff. B. Interviews i. On 12/5/23 at 11:22 a.m., an interview was conducted with registered nurse manager (RN Manager) #1. They stated the facility did not keep the code cart locked. They stated the medications in the cart included epinephrine, bicarb, Narcan, Benadryl, and Solu-medrol. RN Manager #1 explained it was important to ensure that emergency equipment and medications were available for use in an emergency. They said staff could not be searching around for supplies needed in an emergency. They said the time spent searching for supplies needed in a medical emergency could be harmful to patients. Further, they stated patients could die if all emergency medications and equipment were not immediately available. ii. On 12/5/23 at 12:44 p.m., an interview was conducted with the facility operations director (Director) #3. Director #3 stated they were not aware that the code cart was unlocked or that it needed to be locked. iii. On 12/6/23 at 11:00 a.m., an interview was conducted with Director #3. They explained that a staff of three housekeepers came six days a week in the evenings between 6:00 p.m. and 7:00 p.m. and cleaned the facility. They stated housekeeping staff were in the facility alone sometimes and used an access code to enter the facility. Director #3 said the risk of unauthorized individuals, such as housekeeping staff, accessing medications from an unlocked code cart could potentially cause harm to the individual or others. iv. On 12/5/23 at 2:51 p.m., an interview was conducted with the medical director (Director) #7. Director #7 stated they preferred the code cart remained unlocked so staff were not required to unlock the code cart when an emergency occurred. This was in contrast to the general administration of medication policy which read, all medications will be secured by lock and key and accessed only by applicable staff. 2. The facility failed to ensure glucometer test strips and glucose control solutions were not expired and available for use. A. Observations i. On 12/5/23 at 8:10 a.m., an observation of the blood glucose point of care testing (POCT) supplies revealed open glucose test strips which were not labeled with the date they were opened. Therefore, it could not be determined if the glucose supplies were expired and stable for use. This was in contrast to the manufacturer’s instructions for use which read, when the vial of test strips was first opened, the user should have written the date on the vial label. The test strips should have been used within three months of first opening the vial. ii. On 12/5/23 at 8:10 a.m., an observation of the blood glucose point of care testing (POCT) supplies revealed two bottles of glucose control solutions (a glucose solution used to test the function of the glucose meter and test strips) were past the manufacturer’s expiration date of 10/7/22. Each bottle of glucose control solution was marked with the opened date however, the opened date was past the manufacturer’s expiration date. This was in contrast with the manufacturer’s instructions for use which read, the solution should be used before the expiration date printed on the bottle. B. Interviews i. On 12/6/23 at 2:34 p.m., an interview was conducted with patient care technician (PCT) #2. PCT #2 stated the PCT who opened in the morning was responsible for completing the blood glucose control quality control (QC) tests and logging them in the binder. They said the PCT should have checked the bottles, and written down the date, the lot number, and the range. PCT #2 explained the control solutions were good for 30 days and when new bottles were opened, all the information was written in the log again. They said the same process was followed for the test strips. ii. On 12/5/23 at 11:22 a.m., an interview was conducted with registered nurse manager (RN Manager) #1. RN Manager #1 stated the blood glucose test strips should have been dated when the bottle was opened and expired 90 days after it was opened. They said they were shocked that the manufacturer’s expiration date on the bottles of glucose control solutions was from 2022. RN Manager #1 stated the risk to the patient would be an incorrect blood sugar reading and treatment based on the incorrect result. iii. On 12/5/23 at 2:51 p.m., an interview was conducted with medical director (Director) #7. Director #7 stated in general, expired medical supplies should not be used on patients. They said the staff should have done routine checks for expired supplies. They explained staff should have identified expired items and removed them. Specifically, Director #7 said expired glucose control solutions could have caused incorrect readings. 3. The facility failed to ensure expired medical supplies were discarded and not available for patient use. A. Observations i. On 12/4/23 at 2:56 p.m., observations of the treatment floor revealed two BD luer-lok tip 30 ml syringes, expired on 12/31/21. ii. On 12/5/23 at 8:15 a.m., an observation of the medication preparation area revealed the following expired supplies: a. One container of Minncare HD residual test strips (used to test chlorine in water), expired 5/19/22. b. One BD luer-lok tip 30 ml syringe, expired on 8/31/21. c. Ten ProAdvantage cotton-tipped applicators, expired on 9/30/19. d. One bottle of GelRite hand sanitizer, 16 ounces, expired on 10/31/22. e. Two tubes of Covidien Vaseline jelly, 3.25 ounces, expired on 3/31/21. f. One container RPC E-Z Chek Blood Leak Test Strips (used to test for blood in dialysate solution during hemodialysis), expired on 5/31/23. iii. On 12/5/23 at 8:35 a.m., an observation of the laboratory area revealed one Flow-flex Covid-19 Antigen home test, expired on 2/2/23. iv. On 12/5/23 at 9:10 a.m., an observation of the evacuation kit revealed 23 BD gold top vacutainers (tubes used for collecting a blood sample), expired on 11/30/23. This was in contrast to the Supply Management policy that read, supplies were no longer safe to use once they had exceeded their manufacturer’s listed expiration date. Additionally, it stated that staff would discard any expired supplies. B. Interviews i. On 12/6/23 at 2:34 p.m., an interview was conducted with patient care technician (PCT) #2. PCT #2 described the facility process for checking for outdated medical supplies. They stated a PCT was assigned monthly to check medical supplies for inventory and expiration dates. They said the nurses checked the medications for inventory and expiration dates. PCT #2 stated the receptionist and biomedical technician inventoried and checked for expiration dates monthly in the back storage room. They said the boxes of supplies in the back storage area were dated and the stock was rotated every month by the receptionist and biomedical technician. ii. On 12/5/23 at 10:55 a.m., an interview was conducted with registered nurse (RN) #9. RN #9 stated they checked for outdated medical supplies monthly. They said medical supplies expire for a reason and it was important to check for expired supplies to protect the patients. RN #9 stated there was an increased infection risk to patients if expired medical supplies were used on them. iii. On 12/5/23 at 11:22 a.m., an interview was conducted with RN Manager #1. RN Manager #1 stated it was the PCT’s responsibility to check for expired medical supplies throughout the facility and in the lab. They said if a medical supply was expired it should not have been used. RN Manager #1 explained if an expired medical supply was used on a patient, it could have harmed the patient or given the wrong lab results. Additionally, they said it was a risk to patients who could have been treated based on the incorrect lab results. They stated medical supplies that were expired may not have been durable anymore and were not good for patients. iv. On 12/5/23 at 2:51 p.m., an interview was conducted with medical director (Director) #7. Director #7 stated in general, expired medical supplies should not have been used on patients. They said staff were supposed to complete routine checks, identify expired medical supplies, and remove them to ensure they were not available for patient use. Director #7 stated the importance of ensuring expired medical supplies were not available for patient use was to prevent infections in patients.”

“PE-HD PTS IN VIEW DURING TREATMENTS CFR(s): 494.60(c)(4) Patients must be in view of staff during hemodialysis treatment to ensure patient safety, (video surveillance will not meet this requirement). This Standard is not met as evidenced by: 47962 Based on observations, interviews, and document reviews, the facility failed to ensure patient safety during hemodialysis (filtering of the blood using a machine and a filter) treatment. Specifically, the facility failed to ensure patient access sites for dialysis treatments remained visible for 1 of 12 patients observed receiving treatments (Station #12). Findings include: Facility policy: According to the Intradialytic Patient Assessment and Monitoring policy, the purpose is to provide guidelines for intradialytic monitoring of a patient on hemodialysis. Vascular access will be kept uncovered and monitored for infiltration and needle dislodgment. According to the Utilizing the Central Venous Catheter (CVC) for Hemodialysis Treatment Initiation, the purpose is to provide guidelines for safe and effective use of a CVC (tubing inserted into a major vein) for the initiation of hemodialysis. The catheter, catheter site, and all connections must be visible at all times throughout the treatment. A covered access may result in the delay of recognition or treatment of accidental line connection. Accidental line disconnections can result in air embolus, infection, blood loss, or complete exsanguination (death from a complete loss of blood) of the patient. 1. The facility failed to ensure staff visualized and monitored patients’ hemodialysis access sites during treatment according to facility policy. A. Observation i. An observation of the treatment area revealed a patient with a covered access site. On 12/4/23 at 12:10 p.m., a male patient was observed in station #12 receiving treatment with covered access on his left arm. Registered nurse (RN) #1 was present at the next station #13, but did not observe the covered access. RN #1 then walked away. This was in contrast to the Intradialytic Patient Assessment and Monitoring policy which read, vascular accesses were kept uncovered and monitored for infiltration and needle dislodgment. This was also in contrast to the Utilizing the CVC for Hemodialysis Treatment Initiation which read, the catheter, catheter site, and all connections must be visible at all times throughout the treatment. A covered access could delay recognition or treatment of an accidental line connection resulting in an air embolus, infection, blood loss, or complete exsanguination of the patient. B. Interviews i. On 12/4/23 at 12:27 p.m., an interview was conducted with patient care technician (PCT) #2. PCT #2 stated access sites were to remain uncovered at all times. PCT #2 stated patients were at risk for blood loss if access sites were covered and needle dislodgement occurred. ii. On 12/4/23 at 12:31 p.m., an interview was conducted with RN #1. RN #1 stated access sites were to remain uncovered at all times. She stated PCTs monitored the visibility of access sites at 30-minute intervals. RN #1 stated patients were at risk of needle dislodgement resulting in blood loss and potential death of the patient if access sites were covered. These interviews were in contrast to the observation which revealed a patient with a covered access site. iii. On 12/7/23 at 8:02 a.m., an interview was conducted with the operations director (Director) #3. Director #3 stated patients were at risk of dying from blood loss if access sites were covered and needle dislodgement occurred.”

“PA-ASSESS B/P, FLUID MANAGEMENT NEEDS CFR(s): 494.80(a)(2) The patient’s comprehensive assessment must include, but is not limited to, the following: Blood pressure, and fluid management needs. This Standard is not met as evidenced by: 47962 Based on interviews and document review, the facility failed to ensure staff monitored and reported changes in patients’ blood pressure, heart rate, and overall condition and documented communication to nursing staff and providers before, during, and after dialysis (the process of filtering a patient’s blood using a machine and filter) treatment based on facility policy. This failure was observed in one of twelve patients receiving dialysis and in two of six medical records reviewed (Patient #3 and Patient #4). Findings include: Facility policies: According to the Intradialytic Monitoring and Assessment policy, issued 9/26/18, blood pressures will be assessed every 30 minutes or more frequently if the condition warrants. The registered nurse (RN) should notify the physician if blood pressure is out of the facility’s established parameters. Vascular access will be kept uncovered and monitored for infiltration and needle dislodgement. The vascular access status will be documented every 30 minutes. Heart rate will be documented every 30 minutes. RN should notify the physician if the heart rate is out of facility established parameters. The level of consciousness will be monitored continuously and documented at least every 30 minutes. Subjective response to treatment will be evaluated at least every 30 minutes and documented. (e.g., asking the patient about dizziness, leg cramping, or other symptoms). Patients will never be left out of view by at least one staff member. According to the Patient Evaluation: Post Dialysis policy, issued 6/30/98, the purpose is to evaluate the patient and determine if the patient’s condition post-treatment is stable for safe discharge from the facility. Each patient will be assessed after the treatment is discontinued but before discharge from the facility. Documentation will be completed on the hemodialysis flow sheet. The nephrologist will be notified before discharging patients if the nurse deems the patient unstable. The nurse is responsible for the discharge condition of each patient. Assess the patient for vital signs, blood pressure (BP) sitting and standing, pulse rate (heart rate) and rhythm, temperature, respiration rate and quality, weight, vascular access condition, change in mental status, and ambulatory status. According to the Documentation of Medical Care policy, issued 1/31/12, the medical record is a legal document and can be used in a court of law to provide evidence of care that was or was not received. If it was not documented, it did not happen. Reference: The guidelines posted at the nursing station “Please Make the Charge Nurse Aware,” included blood pressure dropping more than 20 points from previous pressure, systolic blood pressure under 90 or above 200, diastolic blood pressure above 100, and pulse (heart rate) above 100 beats per minute (bpm). 1. The facility failed to ensure patient care technicians (PCT) and RNs monitored and reported changes in patients’ statuses and documented communication to nursing staff and medical providers before, during, and after intradialytic treatment based on facility policy and guidelines. A. Observation i. On 12/4/23 at 12:22 p.m., an observation was conducted on the treatment floor. A female patient at station #13 was observed with her left hand raised, attempting to obtain assistance from staff. After being unable to gain the attention of the floor staff, the patient verbally requested the surveyor’s assistance. At this point, the patient stated she felt dizzy and weak. While waiting for staff to arrive, the patient stated she “was going under.” At 12:24 p.m., patient care technician (PCT) #2 arrived at station #13 after the surveyor requested immediate assistance. This observation was in contrast to the Intradialytic Monitoring and Assessment policy which read, the level of consciousness was monitored continuously. Patients were never left out of view by at least one staff member. B. Medical Record Review i. A review of Patient #3’s medical record revealed a lack of monitoring and assessment by care staff during and after dialysis treatment, including documentation that the provider was notified of changes in condition. a. The treatment flow sheet for Patient #3 on 11/18/23 revealed the patient was not assessed post-dialysis treatment by any care staff. The review revealed the Post-Treatment Vital Signs section contained the patient’s post-dialysis weight but the columns with sitting blood pressure (BP), pulse, and temperature were blank and were also not initialed by staff. The Post-Treatment Assessment section was blank and was also not initialed by staff. Additionally, the Pre-Treatment Vital Signs section was completed but was not initialed by the responsible staff member. This medical record review was in contrast to the Patient Evaluation: Post Dialysis policy which read, each patient was assessed after the treatment was discontinued but before discharge from the facility. Documentation was completed on the hemodialysis flow sheet. The nurse was responsible for the discharge condition of each patient. The patient assessment included vital signs, respiration rate and quality, and changes in mental status. b. The treatment flow sheet for Patient #3 revealed on 12/2/23 at 7:11 a.m. before treatment started, the patient complained of feeling tired. At 10:30 a.m., the patient’s heart rate (HR) was 102 (normal heart rate was between 60 - 100). Between 10:41 a.m. and 11:11 a.m., Patient #3’s HR stayed above 100. At 11:11 a.m., his HR had increased to 124. The Procedures, Complications and Notes section time-stamped at 5:16 p.m. by the nurse, revealed the patient was sent to the emergency room due to shaking, increased heart rate, low oxygen saturation (did not have enough oxygen), and shortness of breath. A review of the medical record did not reveal evidence the physician was notified of the HR readings which exceeded facility parameters. This medical record review was in contrast to the Intradialytic Monitoring and Assessment policy which read, the RN notified the physician if the heart rate was out of facility-established parameters. Subjective response to treatment was evaluated at least every 30 minutes and documented, for example asking patients about dizziness, leg cramping, or other symptoms. This was also in contrast to the guidelines posted at the nursing station titled “Please Make the Charge Nurse Aware” which included HR over 100. ii. A review of Patient #4’s medical records revealed he experienced elevations in his blood pressure before dialysis treatment as well as elevations of his diastolic BP (the lower number of a blood pressure reading) and fluctuations in his BP during treatment. a. The treatment flow sheet for Patient #4 revealed on 11/23/23, in the Pre-Treatment Vitals Signs section, Patient #4’s sitting BP at 8:49 a.m. was 174/114 and his standing BP at 8:50 a.m. was 174/114. The Pre-Treatment Assessment by the RN did not reveal any comments or interventions made by the RN for Patient #4. At 9:21 a.m., dialysis was started by the RN with a BP of 159/98. At 9:31 a.m., his diastolic BP had increased to 103, and at 10:31 a.m., had increased to 108. A review of the medical record did not reveal evidence the physician was notified of the BP readings which exceeded facility parameters or any documentation of interventions made at this time. b. The treatment flow sheet for Patient #4 on 11/25/23 at 11:49 a.m. revealed Patient #4 was started on dialysis with a BP of 189/116. Patient #4’s Vitals Signs Pre-Treatment revealed his standing BP was 156/116 and his sitting BP was 153/114. The Pre-Treatment Assessment by the RN was not time stamped nor revealed any comments or interventions made by the RN for Patient #4. At 12:00 p.m., Patient #4’s diastolic BP decreased to 103 and remained at 103 until 1:30 p.m., at which point, his diastolic (bottom number) BP increased to 105. At 2:00 p.m., his diastolic BP had increased again to 110. At 1:30 p.m., the flow sheet comment section revealed PCT #6 wrote, “decreased UFG (ultrafiltration) (pulling water out of the blood) 4600.” At 3:00 p.m., Patient #4’s BP was 113/82 but his HR had increased to 103. At this time, PCT #6 wrote “Turned UF off.” The record review did not reveal other comments by care staff. Further review of Patient #4’s treatment on 11/25/23 revealed the patient’s overall blood pressure fluctuated throughout the treatment. At 11:49 a.m., Patient #4 was started on dialysis with a BP of 189/116. At 12:00 p.m., Patient #4’s BP had decreased to 158/103, a 31-point systolic (top number) decrease over 11 minutes. At 2:30 p.m., Patient #4’s BP was 143/89, and at 3:00 p.m., had decreased to 113/82, a 30-point systolic decrease over 30 minutes. The comments at 3:00 p.m. by PCT #6 revealed she had “turned ultrafiltration (UF) off” with no other detail given. A review of the medical record did not reveal evidence the nurse or physician was notified of these blood pressure or heart rate readings that exceeded facility parameters or any documentation of interventions made at this time. c. The treatment flow sheet revealed on 11/30/23 at 11:39 a.m., Patient #4’s standing BP was 173/101 before the onset of dialysis treatment. His sitting BP at 11:40 a.m. was 171/103. Dialysis was started at 11:45 a.m. The Pre-Treatment Physical Assessment entered by the RN on 11/30/23 at 11:57 a.m. did not reveal that the RN was aware of the increased blood pressure or of any interventions made by the RN at this time. The flow sheet revealed on 11/30/23 at 12:39 p.m., Patient #4’s BP was 187/110 and at 1:09 p.m., 30 minutes later, his BP had decreased to 156/104, a 31-point decrease over 30 minutes. A review of the medical record did not reveal evidence the nurse or physician was notified of the blood pressure readings that exceeded facility parameters or any documentation of interventions made at this time. d. The treatment flow sheet revealed on 12/2/23 at 11:55 a.m., Patient #4’s pre-treatment sitting BP was 173/102 and at 11:57 a.m., his pre-treatment standing BP was 185/109. Dialysis was started at 12:03 p.m. The Pre-Treatment Physical Assessment by the RN on 12/2/23 entered at 5:00 p.m. as a late entry, did not contain any comments or interventions made for Patient #4. At 12:09 p.m., Patient #4’s BP was 207/108 and at 12:30 p.m., had decreased to 186/88, a 21-point drop over 21 minutes. A review of the medical record did not reveal evidence the nurse or physician was notified of these blood pressure readings that exceeded facility parameters or any documentation of interventions made at this time. This medical record review was in contrast to the Intradialytic Monitoring and Assessment policy which read, the RN notified the physician if blood pressure and heart rate were out of the facility’s established parameters. This was also in contrast to the guidelines posted at the nursing station titled “Please Make the Charge Nurse Aware” which included blood pressure dropping more than 20 points from previous pressure, systolic blood pressure under 90 or above 200, and diastolic blood pressure above 100. C. Interviews i. On 12/6/23 at 2:34 p.m., an interview was conducted with PCT #2. PCT #2 stated facility parameters for vital signs were posted at the nurses’ station. She stated if a patient’s vitals were outside facility parameters before or during treatment, she would let the nurses know and document this communication. PCT #2 stated even for patients with a history of high blood pressure, such as Patient #4, she still notified the RN if his blood pressure exceeded facility parameters. She stated the nurses called the physician if vitals were outside facility parameters so the physician could determine if the patient was safe on dialysis. PCT #2 stated it was important for PCTs to inform the nurse of changes in patient condition to ensure patients would not pass out, have issues with cramping during treatment, or even code (a code used to indicate a patient requiring resuscitation) ii. On 12/6/23 at 3:13 p.m., an interview was conducted with registered nurse (RN) #9. RN #9 stated if a patient’s vitals were outside facility parameters, the PCT should have notified the RN and requested an assessment as this could have changed the patient’s treatment goals. RN #9 stated nurses performed a treatment assessment of every patient to ensure patient safety. She stated the risks of vitals exceeding facility parameters included the patient becoming unresponsive, an impact on the patient’s heart, or a stroke (lack of blood flow to the brain). iii. On 12/7/23 at 8:54 a.m., an interview was conducted with RN Manager #8. RN Manager #8 stated she documented changes in the patient’s condition or any concerns the patient had during treatment on the treatment flowsheet. She also stated if a patient was chronically hypertensive (elevated blood pressure), she instructed her nurses to write a note stating the patient was chronically hypertensive and the physician was aware. RN Manager #8 stated if a patient’s BP was elevated and did not decrease during treatment, she gave the patient a physician-approved medication to lower their blood pressure and then contacted the physician if the patient’s condition did not improve from there. RN Manager #8 stated she would document this interaction in the flow sheet, including any orders given by the physician. RN Manager #8 stated the risk of not being monitored by care staff included harm to the patient and potentially the patient’s death. iv. On 12/7/23 at 8:02 a.m. an interview was conducted with operations director (Director) #3. Director #3 stated her background was in social work so she could not speak to clinical risks but knew that if staff did not monitor, assess, or notify the RN or provider of changes in BP, HR, or patient condition, there was a risk to the patient. These interviews were in contrast to the review of medical records for Patient #3 and Patient #4, which revealed multiple instances of abnormal BP, HR, or a change in condition without the RN or provider being notified.”

“QAPI-PRIORITIZING IMPROVEMENT ACTIVITIES CFR(s): 494.110(c) The dialysis facility must set priorities for performance improvement, considering prevalence and severity of identified problems and giving priority to improvement activities that affect clinical outcomes or patient safety. This Standard is not met as evidenced by: 47962 Based on interviews and document review, the facility failed to ensure quality assessment and performance improvement (QAPI) identified problems, considered the prevalence and severity of identified problems, and gave priority to improvement activities that affected patient safety. (Cross reference V504, V763). Findings include: Facility policies: According to the Quality Assessment Performance Improvement (QAPI) policy, published without an issue date, the purpose is to provide guidance on the development and maintenance of an effective QAPI program. The facility must develop, implement, maintain, and evaluate an effective, data-driven, QAPI program with participation by the professional members of the interdisciplinary team. The 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. The dialysis facility must set priorities for performance improvement, considering the prevalence and severity of identified problems and giving priority to improvement activities that affect clinical outcomes or patient safety. The facility must immediately correct any identified problems that threaten the health and safety of patients. According to the Creation, Revision, and Review of Clinic Policies policy, issued 12/7/23, the purpose is to ensure policies are current, relevant, and available in an organized sequence. Having a written policy and procedures will give clear instructions and provide documentation of changes, updates, and dates of implementation. All policies and procedures will be reviewed each January and edited as needed. The implementation of policies will be reviewed and adopted by the facility’s governing body before being implemented at the clinics. When a policy needs to be updated or retired, the request will be added to the governing body meeting minutes and will be discussed and documented. When the policies and procedures are distributed, the policy will have an issued date. All retired or altered policies will be archived. According to the Intradialytic Monitoring and Assessment policy, blood pressures will be assessed every 30 minutes or more frequently if the condition warrants. The registered nurse (RN) should notify the physician if blood pressure is out of the facility’s established parameters. Vascular access will be kept uncovered and monitored for infiltration and needle dislodgement. The vascular access status will be documented every 30 minutes. Heart rate will be documented every 30 minutes. RN should notify the physician if the heart rate is out of the facility’s established parameters. The level of consciousness will be monitored continuously and documented at least every 30 minutes. Subjective response to treatment will be evaluated at least every 30 minutes and documented. (e.g., asking the patient about dizziness, leg cramping, or other symptoms). 1. The facility failed to ensure QAPI identified a problem, specifically monitoring patients before, during, and after dialysis, and considered the prevalence and severity of an identified problem, the lack of timely and comprehensive review of policies, and gave priority to improvement activities that affected patient safety. A. Document review i. A review of Patient #3 and #4’s medical records revealed blood pressure (BP) and heart rate (HR) readings which exceeded facility parameters during the time the patient presented for dialysis (the process of filtering the blood using a machine and a filter) treatment were not reported to nursing staff and providers and interventions were not implemented in response. Upon request, the facility was not able to provide documentation of quality improvement activities identifying and taking action to improve monitoring and assessment of vital signs. This record review was in contrast to the QAPI policy which read, the dialysis facility measured, analyzed, and tracked quality indicators or other aspects of performance which reflected processes of care. The dialysis facility gave priority to improvement activities which affected patient safety. ii. A review of facility policies provided by operations director (Director) #3 between 12/4/23 to 12/7/23 revealed policies were inconsistently reviewed and updated and outdated policies were accessible to staff. Examples included: a. Between the dates 12/4/23 to 12/7/23, operations director (Director) #3 provided a policy issued in 1996, then later provided this same policy, updated in 2018. She also provided two policies issued in 1998, then later provided updated policies, one in 2017 and the other in 2023. b. On 12/4/23 and 12/5/23, upon requesting the facility’s infection control policy for more information on the facility’s policy and procedure regarding single-use medical equipment, Director #3 provided the following policies: Universal Precautions, issued 7/11/17, Surface Disinfection - Dilution of 1:100 Bleach Solution, issued 1/16/19, and Surface Cleaning in the Dialysis Setting, issued 7/11/17 and Cleaning Reusable Supplies, issued 7/11/17. This document review was in contrast to the Creation, Revision, and Review of Clinic Policies policy which read, the purpose was to ensure policies were current, relevant, and available. All policies and procedures were reviewed each January and edited as needed. c. Upon request on 12/6/23 and 12/7/23, Director #3 was unable to provide a policy referenced by name in another policy and provided two other policies in its place. This document review was in contrast to the QAPI policy which read, the facility set priorities for performance improvement, considering prevalence and severity of identified problems and gave priority to improvement activities which affected patient safety. B. Interviews i. On 12/7/23 at 8:54 a.m., an interview was conducted with registered nurse (RN) manager (RN Manager) #8. RN Manager #8 stated she participated in quality meetings at the facility. She stated QAPI identified, measured, and analyzed problems, tracked and trended data, and addressed identified problems through staff education. RN Manager #8 stated the policies at the facility were unclear and this was an issue the facility needed to improve. She stated the quality team had not identified or implemented any projects related to monitoring by care staff at this facility. RN Manager #8 stated the risk of not identifying, tracking and trending problems, or implementing interventions included the loss of vascular access, chronic anemia (lower than normal amounts of healthy red blood cells), and patient harm or death. ii. On 12/5/23 at 12:45 p.m. and 12/7/23 at 9:46 a.m., interviews were conducted with Director #3. Director #3 stated she participated in quality and governing body meetings at the facility along with the nurse managers and the medical director. She stated she had identified issues with creating and updating policies at an earlier date but the facility had not yet hired the nurse educator who would be in charge of this project. Director #3 stated there was a quality plan the facility followed to ensure the patients received quality care which included tracking and trending data. However, she stated facility leadership and quality staff did not currently review medical records for monitoring during dialysis and notifications to the RN or provider. She stated the risk of not having a QAPI program that identified problems and implemented performance improvement activities as a result of identified problems, was a risk of harm to the patient.”

“GOV-GB INFORMS MED STAFF OF P&P/QAPI PROG CFR(s): 494.180(c)(2),(3) The governing body- (2) Ensures that all medical staff who provide care in the facility are informed of all facility policies and procedures, including the facility’s quality assessment and performance improvement program specified in §494.110. (3) Communicates expectations to the medical staff regarding staff participation in improving the quality of medical care provided to facility patients. This Standard is not met as evidenced by: 47962 Based on observations, interviews, and document review, the facility failed to ensure policies were comprehensive, updated, and easily accessible to staff. Also, the facility failed to ensure the medical staff met regularly and maintained written records of their meetings. Additionally, the facility failed to ensure the medical staff bylaws were current. Findings include: Facility policies: According to the Creation, Revision, and Review of Clinic Policies policy, issued 12/7/23, the purpose is to ensure policies are current, relevant, and available in an organized sequence. Having a written policy and procedures will give clear instructions and provide documentation of changes, updates, and dates of implementation. All policies and procedures will be reviewed each January and edited as needed. The implementation of policies will be reviewed and adopted by the facility’s governing body before being implemented at the clinics. When a policy needs to be updated or retired, the request will be added to the governing body meeting minutes and will be discussed and documented. When the policies and procedures are distributed, the policy will have an issued date. All retired or altered policies will be archived. According to the Utilizing the Central Venous Catheter for Hemodialysis Treatment Initiation policy, perform catheter disinfection per policy (see policy Pre-treatment Care and Disinfection of the Central Venous Catheter). Reference: The Medical Staff Bylaws read, the general responsibilities of the medical staff members included medical staff were to attend at least 50% of the scheduled meetings of the medical staff in each two-year period unless specifically excused by the medical director and to attend any other meetings scheduled by the medical director pertaining to clinic operations or patient care. These medical staff bylaws were approved and ratified as follows: signed by the president of the Executive Committee on 8/15/18 and signed by the chair of the Board of Directors on 8/15/18. 1. The facility failed to ensure dialysis policies were comprehensive, updated, and easily accessible to staff. A. Document review i. Between the dates 12/4/23 to 12/7/23, upon requesting all of the facility’s arteriovenous fistula (AVF) and central venous catheter (CVC) initiation and discontinuation policies, operations director (Director) #3 provided the Subclavian Catheter: Routine Care and Dressing Change policy, originally issued 9/96, then later provided an updated policy, issued 4/10/18. She also provided the CVC Preparation for Dialysis policy, issued 6/30/98, then later provided an updated policy, issued 7/11/17. Additionally, Director #3 provided the Preparation and Cannulation of the Fistula and Graft policy, issued 6/30/98, and later provided an updated policy, issued 3/5/23. This document review was in contrast to the Creation, Revision, and Review of Clinic Policies policy which read, the purpose was to ensure policies were current, relevant, and available. All policies and procedures were reviewed each January and edited as needed. All retired or altered policies were archived. ii. On 12/4/23 and 12/5/23, upon requesting the facility’s infection control policy for more information on the facility’s policy and procedure regarding single-use medical equipment, Director #3 provided the following policies: Universal Precautions, issued 7/11/17, Surface Disinfection - Dilution of 1:100 Bleach Solution, issued 1/16/19, and Surface Cleaning in the Dialysis Setting, issued 7/11/17 and Cleaning Reusable Supplies, issued 7/11/17. This document review was in contrast to the Creation, Revision, and Review of Clinic Policies policy which read, the purpose was to ensure policies were current, relevant, and available. All policies and procedures were reviewed each January and edited as needed. iii. Upon request on 12/6/23 and 12/7/23, Director #3 was unable to provide the Pre-Treatment Care and Disinfection of the CVC policy which was referenced in the Utilizing the CVC Catheter for Hemodialysis Treatment Initiation policy. On 12/7/23, Director #5 instead provided the Subclavian Catheter: Routine Care and Dressing Change issued 4/10/18 and Central Venous Catheter Preparation for Dialysis issued 7/11/17 policies. This document review was in contrast to the Creation, Revision, and Review of Clinic Policies policy which read, the purpose was to ensure policies were current, relevant, and available. All policies and procedures were reviewed each January and edited as needed. iv. A review of facility policies revealed policies were not uniformly updated and available to the staff. In addition to the policies referenced above, other examples included: a. Post-Dialysis Care of the Fistula/Graft, issued 6/30/98 b. CVC: Post-Dialysis Care, issued 6/30/98 c. AV Fistula Care and Complications, issued 6/30/98 There was no evidence that the policies were reviewed and updated since the issued date. This document review was in contrast to the Creation, Revision, and Review of Clinic Policies which read, the purpose was to ensure policies were current, relevant, and available. All policies and procedures were reviewed each January and edited as needed. All retired or altered policies were archived. B. Interviews i. On 12/6/23 at 2:34 p.m., an interview was conducted with patient care technician (PCT) #2. PCT #2 stated in her role as a trainer for new staff, she made printouts of the facility’s policies from the facility’s intranet to ensure trainees had easy access to the information they needed. PCT #2 stated staff needed to be careful when accessing policies to make sure they found the most current policies, as both old and new policies were available on the facility’s intranet ii. On 12/6/23 at 3:13 p.m., an interview was conducted with registered nurse (RN) #9. RN #9 stated she found it easy to find the correct policy when needed on the facility’s intranet. In contrast to this previous statement, RN #9 then stated both new and old policies were available for staff review online, and the older policies were marked as “retired” in the title. RN #9 also stated the governing body made policy updates when needed. RN #9 stated the risk of keeping outdated policies available and not updating policies was a risk to the patients while providing care. This was in contrast to the review of policies which showed no evidence that policies were reviewed in accordance with facility policy. iii. On 12/7/23 at 8:54 a.m., an interview was conducted with RN Manager #8. RN Manager #8 stated staff did not have clear guidelines on the best patient care practices policies as the policy revision process was done randomly. She stated the risk of not having current policies written and available to staff included staff not following the most current and best practices for the patients. iv. On 12/7/23 at 9:46 a.m., an interview was conducted with Director #3. Director #3 stated policies were online and readily available to staff, including any updated policies. She stated there was a folder for any archived policies. Director #3 stated she had requested updates to current facility policies as many needed to be revised but as a non-clinical staff member, Director #3 had to rely on her staff for policy creation and revision. Director #3 stated the risk of keeping outdated policies available to floor staff and the governing body not updating policies was patients not receiving the best and most updated information and care. 2. The facility failed to ensure the medical staff met regularly and maintained written records of those meetings. A. Document review i. Upon request, the facility was unable to provide minutes of medical staff meetings. This was in contrast to the Medical Staff Bylaws which read, the general responsibilities of the medical staff members included medical staff were to attend at least 50% of the scheduled meetings of the medical staff in each two-year period unless specifically excused by the medical director. Medical staff were also to attend any other meetings scheduled by the medical director that pertained to clinic operations or patient care. B. Interviews i. On 12/5/23 at 2:51 p.m., an interview was conducted with medical director (Director) #7. Director #7 stated the facility did not have formal medical staff meetings. They said they met with medical staff members on an informal basis frequently and discussed patient care as well as other issues that pertained to clinic operations. Director #7 stated it was important the medical staff communicated because it was the right thing to do for patients and maintained collegiality. ii. On 12/7/23 at 8:02 a.m., an interview was conducted with operations director (Director) #3. Director #3 stated medical staff meetings at the facility were informal and there were no documented meeting minutes. They said the risk of not having formal medical staff meetings was that providers were not aware of current issues at the clinic. This was in contrast to the Medical Staff Bylaws which read, the general responsibilities of the medical staff members included medical staff were to attend at least 50% of the scheduled meetings of the medical staff in each two-year period unless specifically excused by the medical director. Medical staff were also to attend any other meetings scheduled by the medical director that pertained to clinic operations or patient care. 3. The facility failed to ensure the medical staff by-laws were reviewed and approved annually by the medical staff and governing body. A. Document review i. A review of the facility’s medical staff bylaws revealed the last approval date on the medical staff bylaws was 8/15/18. ii. Upon request, the facility was unable to provide governing body bylaws. This was in contrast to the Creation, Revision, and Review of Clinic Policies policy which read, all policies and procedures would be reviewed each January and edited as needed. B. Interviews i. On 12/7/23 at 8:02 a.m., an interview was conducted with the operations director (Director) #3. Director #3 stated the facility’s medical staff bylaws were not reviewed and approved annually or at scheduled intervals. They said there was nothing more current than the medical staff bylaws signed on 8/15/18. Additionally, Director #3 stated the medical staff bylaws included the governing body bylaws.”