062525 La Junta Dialysis (Fmc)

“CFC-INFECTION CONTROL CFR(s): 494.30 This Condition is not met as evidenced by: 45020 Based on the manner and degree of the standard level deficiencies referenced to the Condition, it was determined the Condition of Participation §494.30 Infection Control, was out of compliance. V113 - Wear disposable gloves when caring for the patient or touching the patient ’ s equipment at the dialysis station. Staff must remove gloves and wash hands between each patient or station. Based on observation, staff interview, and review of the facility’s policy, the facility failed to ensure three of three patients, who were observed holding pressure to their access sites (locations where needles were inserted and then removed for treatment), performed hand hygiene following the removal of soiled gloves and prior to leaving the facility. V122 - [Standard: Procedures for infection control. The facility must demonstrate that it follows standard infection control precautions by implementing-] [Maintaining procedures, in accordance with applicable State and local laws and accepted public health procedures, for the-](ii) Cleaning and disinfection of contaminated surfaces, medical devices, and equipment. Based on observations, interviews and document review, the facility failed to ensure the dialysis station bleach cleaning solution was labeled per facility policy to ensure its efficacy in one of two observations of the patient care area. V143 - [Standard: Oversight. The facility must -] Ensure that clinical staff demonstrate compliance with current aseptic techniques when dispensing and administering intravenous medications from vials and ampules. Based on observations, document review and interviews, the facility failed to ensure clinical staff demonstrated compliance when dispensing and administering intravenous (IV) medication from vials. Specifically, the facility failed to label a multi-dose vial (MDV) to ensure the correct expiration date was noted in one of one observations. V146 - The facility must demonstrate that it follows standard infection control precautions by implementing-](2) The “Guidelines for the Prevention of Intravascular Catheter-Related Infections” entitled “Recommendations for Placement of Intravascular Catheters in Adults and Children” parts I - IV; and “Central Venous Catheters, Including PICCs, Hemodialysis, and Pulmonary Artery Catheters in Adult and Pediatric Patients.” Based on observations, interviews, and document review, the facility failed to ensure patient care staff allowed dry time after the hub of the central venous catheter (CVC), a device inserted through the skin for direct access to a large vein in the patient for dialysis treatment) was cleaned in four of four observations of CVC end of treatment procedures.”

“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: 45020 Based on observation, staff interview, and review of the facility’s policy, the facility failed to ensure three of three patients, who were observed holding pressure to their access sites (locations where needles were inserted and then removed for treatment), performed hand hygiene following the removal of soiled gloves and prior to leaving the facility. Findings include: Facility policy: The Hand Hygiene policy read, the purpose of this policy is to prevent transmission of pathogenic microorganisms to patients and staff through cross contamination. All staff, patients, patient care givers, including physicians and non-physician practitioners, social workers, dietitians, and any other indirect patient care staff must follow the same requirements for hand hygiene. Hand Hygiene: Patients: Patients should perform hand hygiene if able, prior to and after each dialysis treatment. As needed, direct patient care staff will demonstrate how to operate the sinks, demonstrate hand washing to patients who are able to perform hand washing, and explain risk of contamination with regard to their vascular access and hands to all patients. Gloves must be provided to patients when performing procedures which risk exposure to blood or body fluids, such as when self-cannulating or holding access sites post treatment to achieve hemostasis.To help ensure the prevention of cross contamination to their family members or other patients, hand hygiene must be performed. 1. The facility failed to ensure patients performed hand hygiene following the removal of soiled gloves. A. Observations i. On 10/1/24 at 10:31 a.m., an observation was conducted at station #14. The patient was observed holding pressure to their own site with a gloved right hand following the removal of the needle used for treatment. At 10:35 a.m., the second needle was removed and the patient was observed holding pressure to both access sites. At 10:41 a.m., after stabilization of the site, a staff member applied a dressing to the site. The patient then removed the soiled glove and without performing hand hygiene, gathered their belongings, ambulated to the scale, their weight was obtained by a staff member and the patient exited the facility. Staff did not educate or request the patient to perform hand hygiene following the glove removal. ii. On 10/2/24 at 9:45 a.m., an observation was conducted at station #11. The patient was observed holding pressure to their own access site with a gloved right hand following the removal of the needles used for treatment. At 9:49 a.m., a staff member reinforced the bleeding access site with gauze. At 10:13 a.m., after stabilization of the site, a staff member applied a dressing to the site and assisted the patient with glove removal. The patient gathered their belongings, ambulated to the scale, their weight was obtained by a staff member and the patient exited the facility. Staff did not educate or request the patient to perform hand hygiene following the glove removal. iii. On 10/2/24 at 9:46 a.m., an observation was conducted at station #5. The patient was observed holding pressure to their own site with a gloved right hand following the removal of the needle used for treatment. At 9:52 a.m., the second needle was removed and the patient was observed holding pressure to both access sites. At 9:56 a.m., a staff member reinforced the dressing to the access sites and assisted the patient with glove removal. The patient ambulated to the scale their weight was obtained by a staff member and the patient exited the facility. Staff did not educate or request the patient to perform hand hygiene following the glove removal. B. Interviews i. On 10/3/24 at 8:41 a.m., an interview was conducted with patient care technician (PCT) #2. PCT #2 stated after the patient’s access site was stabilized, the patient was to remove their glove and perform hand hygiene. PCT #2 stated there was a risk of the patient having blood on their hand which could have been an infection risk which could cause colds or Covid. ii. On 10/3/24 at 9:38 a.m., an interview was conducted with registered nurse (RN) #3. RN #3 stated patients were to perform hand hygiene when they entered the treatment area and again before leaving the treatment area. RN #3 stated if a patient did not perform hand hygiene after glove removal there was a risk of infection such as hepatitis, colds, and the flu because they touch the doors on the way out of the facility. iii. On 10/3/24 at 10:09 a.m., an interview was conducted with infection preventionist manager (Manager) #4. Manager #4 stated it was important for patients to perform hand hygiene because there was a risk of spreading germs at the scale or the door as they left the facility which could cause the spread of viruses.”

“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: 45020 Based on observations, interviews and document review, the facility failed to ensure the dialysis station bleach cleaning solution was labeled per facility policy to ensure its efficacy in one of two observations of the patient care area. Findings include: Facility policy: The Mixing Bleach policy read, The purpose of this policy is to provide instruction on bleach dilution. Label the opaque container with “Bleach Solution”, strength of solution, date and time prepared, and preparer’s initials. 1. The facility failed to ensure patient care staff prepared the bleach solution used to clean patient chairs, dialysis machines and supplies used in patient care according to facility policy. Specifically, the bleach containers were not labeled with the date, time and initials which identified when the bleach solution was prepared. A. Observation i. On 10/1/24 at 10:32 a.m., the patient care area was observed. One container filled with a solution was observed in the sink area on the countertop. The container had a label indicating they were filled with a bleach solution, however, there was no documentation of the date and time of when the bleach solutions were prepared or which staff member mixed the solution. B. Interviews i. On 10/3/24 at 8:41 a.m., an interview was conducted with patient care technician (PCT) #5. PCT #5 stated the bleach solution in these containers were used to disinfect dialysis machines and patient chairs. PCT #5 stated it was important for a label to be placed on the containers with the date and time it was prepared because the bleach solutions were not as effective after 24 hours and might not have cleaned surfaces effectively. ii. On 10/3/24 at 9:38 a.m., an interview was conducted with registered nurse (RN) #3. RN #3 stated bleach containers were to be labeled with the date and time of preparation, the initials of the teammate who prepared it and the strength of the solution. RN #3 stated the bleach solution was to be discarded at the end of each treatment day because the solution lost potency after 24 hours. RN #3 stated if bleach solution was not labeled and used, there was a risk of infection, which could cause sepsis and possible death. iii. On 10/3/24 at 10:09 a.m., an interview was conducted with infection preventionist manager (Manager) #4. Manager #4 stated their expectation was for the bleach bins to be labeled with the date, time, strength and initials when the solution was prepared. Manager #4 stated there was a risk the bleach could be more diluted if the bleach solution were to be used after 24 hours.”

“IC-ASEPTIC TECHNIQUES FOR IV MEDS CFR(s): 494.30(b)(2) [The facility must-] (2) Ensure that clinical staff demonstrate compliance with current aseptic techniques when dispensing and administering intravenous medications from vials and ampules; and This Standard is not met as evidenced by: 45020 Based on observations, document review and interviews, the facility failed to ensure clinical staff demonstrated compliance when dispensing and administering intravenous (IV) medication from vials. Specifically, the facility failed to label a multi-dose vial (MDV) to ensure the correct expiration date was noted in one of one observations. Findings include: Facility policy: The Medication Preparation and Administration policy read, the purpose of this policy is to administer medications with the goals of staff and patient safety, optimal therapeutic response, and infection control. If the vial is not used immediately in its entirety after opening, the nurse or patient care technician (PCT), must label the date and time the vial was opened on the medication label along with their initials. The nurse must never walk away from an opened multi-dose vial (MDV) without writing the date and time the vial was opened. Any MDV must be discarded 28 days after opening or according to the manufacturer’s expiration date. 1. Facility staff failed to label multi-dose vials of medication with a date when opened. A. Observation i. On 10/1/24 at 10:34 a.m., observations of the facility’s medications revealed an open MDV of Heparin (a medication used to decrease the clotting ability of blood) stored in a drawer. There was no date to indicate when the medication was opened. This observation was in contrast to facility policy which stated the nurse or PCT must label the date and time the vial was opened on the medication label along with their initials. B. Interviews i. On 10/3/24 at 8:41 a.m., an interview was conducted with PCT #2. PCT #2 stated when a MDV medication was opened, the staff member opening the vial must label the vial with the date it was opened. PCT #2 stated if the vial was not dated when it was opened, other staff members would not know when the vial was opened and could administer an expired medication to the patient. ii. On 10/3/24 at 9:09 a.m., an interview was conducted with PCT #5. PCT #5 stated MDVs were to be labeled with the time and date it was opened. PCT #5 stated if the medication vial was not dated when it was opened, there was a risk the medication could be expired and cause harm to the patients. iii. On 10/3/24 at 10:09 a.m., an interview was conducted with infection preventionist manager (Manager) #4. Manager #4 stated it was important to label MDV to ensure the medication was still safe to be administered to the patient. Manager #4 stated if the medication was not labeled appropriately and expired and was then administered to the patient, there was a risk the medication could be contaminated.”

“IC-CATHETERS:GENERAL CFR(s): 494.30(c)(2) (2) The “Guidelines for the Prevention of Intravascular Catheter-Related Infections” entitled “Recommendations for Placement of Intravascular Catheters in Adults and Children” parts I - IV; and “Central Venous Catheters, Including PICCs, Hemodialysis, and Pulmonary Artery Catheters in Adult and Pediatric Patients,” Morbidity and Mortality Weekly Report, volume 51 number RR-10, pages 16 through 18, August 9, 2002. The Director of the Federal Register approves this incorporation by reference in accordance with 5 U.S.C. 552(a) and 1 CFR Part 51. This publication is available for inspection as the CMS Information Resource Center, 7500 Security Boulevard, Central Building, Baltimore, MD or at the National Archives and Records Administration (NARA). Copies may be obtained at the CMS Information Resource Center. For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal_register/code_of_regulations/ibr_locations.html This Standard is not met as evidenced by: 45020 Based on observations, interviews, and document review, the facility failed to ensure patient care staff allowed dry time after the hub of the central venous catheter (CVC), a device inserted through the skin for direct access to a large vein in the patient for dialysis treatment) was cleaned in four of four observations of CVC end of treatment procedures. Findings include: Facility policies: The initiation of Treatment Using a Central Venous Catheter and Optiflux Single Use Ebeam Dialyzer policy read, remove cap from clamped arterial limb. Using a sterile alcohol pad scrub the sides (threads) and end of the hub thoroughly with friction, making sure to remove any residue (e.g., blood) (This step should take 10-15 seconds). Hold the limb while allowing the antiseptic to dry. Repeat these steps for the venous end of the catheter limb. The Termination of Treatment Using a Central Venous Catheter and Optiflux Single Use Ebeam Dialyzer policy read, disconnect the arterial bloodline line from the catheter limb. Using a sterile alcohol pad scrub the sides (threads) and end of the hub thoroughly with friction, making sure to remove any residue (e.g., blood) (This step should take 10-15 seconds). Hold the limb while allowing the antiseptic to dry. Immediately attach a prefilled saline syringe to the catheter limb. Repeat these steps for the venous end of the catheter limb. 1. The facility failed to ensure patient care staff allowed dry time after the hub of the CVC catheter was cleaned. A. Observations i. On 10/1/24 at 11:04 a.m., an observation was conducted of a CVC end of treatment procedure at station #12. After the dialysis lines were removed from the patient, the CVC was prepared for the patient to leave the facility. Patient care technician (PCT) #1 scrubbed the red hub for 30 seconds, no dry time was observed, a syringe which contained normal saline (NS) was attached to the hub and administered, followed by a syringe which contained Heparin (a medication used to prevent clots) was attached to the hub and administered. PCT #1 then applied a cap to the red hub, which remained visibly wet. PCT #1 removed their gloves, performed hand hygiene, donned new gloves and scrubbed the blue hub for 20 seconds. After the hub was scrubbed,the PCT connected a syringe of NS to the hub and administered the NS. There was no dry time observed prior to the connection of the syringe. PCT #1 then applied a cap to the blue hub, which remained visibly wet. ii. On 10/2/24 at 9:52 a.m., an observation was conducted of a CVC end of treatment procedure at station #4. After the dialysis lines were removed from the patient and the CVC was prepared for the patient to leave the facility. PCT #1 scrubbed the red hub for 13 seconds and then immediately attached a syringe to the hub and administered NS. There was no dry time observed prior to the connection of the syringe. The same process was observed while PCT #1 scrubbed the blue hub. PCT #1 had not allowed dry time prior to the attachment and administration of NS. PCT #1 then applied a cap to the blue hub, which remained visibly wet. These observations were in contrast to the Termination of Treatment Using a Central Venous Catheter and Optiflux Single Use Ebeam Dialyzer policy, which read, hold the limb while allowing the antiseptic to dry. iii. On 10/2/24 at 7:44 a.m., an observation was conducted of a CVC initiation of treatment procedure at station #16. PCT #2 removed the caps of the CVC and scrubbed the hubs with an alcohol pad for 40 seconds, then immediately attached a syringe to each hub and withdrew blood. The hubs were visibly wet when the syringe was attached. iv. On 10/2/24 at 11:16 a.m., an observation was conducted of a CVC initiation of treatment procedure at station #1. PCT #1 removed the caps of the CVC and scrubbed the hubs with an alcohol pad for 19 seconds, then immediately attached a syringe to each hub and withdrew blood. The hubs were visibly wet when the syringe was attached. When asked if there was a dry time to the hubs after alcohol scrub, PCT #1 stated there was no dry time for alcohol. These observations were in contrast to the Initiation of Treatment Using a Central Venous Catheter and Optiflux Single Use Ebeam Dialyzer policy which read, hold the limb while allowing the antiseptic to dry. B. Interviews i. On 10/3/24 at 8:41 a.m., an interview was conducted with PCT #2. PCT #2 stated CVC hubs were to be scrubbed for 30 seconds. PCT #2 stated they were not aware of a dry time after the hubs were scrubbed with an alcohol pad. PCT #2 stated it was important to follow facility policy for CVC care because the CVC line went directly to the patient’s heart and there was a risk of infection, which could be life threatening. ii. On 10/3/24 at 9:38 a.m., an interview was conducted with registered nurse (RN) #3. RN #3 stated CVC hubs were to be scrubbed with alcohol for 10-15 seconds and allowed to air dry. RN #3 stated CVC hubs were to be scrubbed with alcohol and allowed to air dry because alcohol needed dry time to disinfect the area. RN #3 stated policies were in place to prevent infection. RN #3 stated the risk of an infection to a CVC site included sepsis and hospitalization. iii. On 10/3/24 at 10:09 a.m., an interview was conducted with infection preventionist manager (Manager) #4. Manager #4 stated CVC hubs were to be scrubbed for 15 seconds and allowed to air dry to prevent alcohol from getting into the system. Manager #4 stated it was facility policy to allow the CVC hubs to air dry. Manager #4 stated policies were in place to prevent infection. Manager #4 stated the risk of an infection to a CVC site included sepsis and possible death.”

“PE-EQUIPMENT MAINTENANCE-MANUFACTURER’S DFU CFR(s): 494.60(b) The dialysis facility must implement and maintain a program to ensure that all equipment (including emergency equipment, dialysis machines and equipment, and the water treatment system) are maintained and operated in accordance with the manufacturer’s recommendations. This Standard is not met as evidenced by: 45020 Based on observations, document review, and interviews, the facility failed to have a process in place to ensure supplies had not expired and were unavailable for patient use in one of two emergency carts. Findings include: Facility policies: The Storage of Supplies policy read, the purpose of this policy is to provide guidelines for storage and handling of supplies. Proper storage conditions are necessary to provide a safe environment and to ensure supplies are not expired, contaminated or damaged. Supplies must be rotated to ensure products maintain quality and do not expire. Dispose of items that have reached the expiration date. The Expiration Dates Sterile Supplies policy read, the purpose of this policy is to provide guidance on checking expiration dates to assure that sterile supplies are taken out of circulation by the expiration date. Sterile items will be checked before use to ensure that they have not expired. Appropriately dispose of sterile items that have reached the expiration date. Expiration dates of sterile supplies contained in emergency boxes or code carts should be noted and logged as per facility protocol. 1. The facility failed to ensure expired medical supplies were discarded and not available for patient use. a. On 10/1/24 at 10:58 a.m., an observation of the code cart (cart on wheels containing emergency medications and supplies which could be brought to the site of a medical emergency for life support) revealed the following expired medical supplies: i. Four bags of Sodium Chloride 0.9%, 150 milliliters (ml), expired on 3/2024. ii. One box of 25 single dose vials of Adrenalin 1 ml, expired 3/2024. This was in contrast to the Expiration Dates Sterile Supply policy which read, Appropriately dispose of sterile items that have reached the expiration date. b. On 10/3/24 at 9:38 a.m., an interview was conducted with registered nurse (RN) #3. RN #3 stated the clinic manager checked the supplies once a month. RN #3 stated there was a risk to the patient if expired medical supplies were used for patient care including the medication not working properly because it could have decreased potency. c. On 10/3/24 at 10:09 a.m., an interview was conducted with clinic manager (Manager) #4. Manager #4 stated they were responsible for the monthly check for outdated supplies on the code cart. Manager #4 was unsure why the sodium chloride bags were in the code cart and stated they needed to be more diligent when they checked expiration dates. Manager #4 stated the risk of using expired medical supplies for patient care was the medications might not be as effective and it was an unforeseen risk.”

“POC-ACHIEVE ADEQUATE CLEARANCE CFR(s): 494.90(a)(1) Achieve and sustain the prescribed dose of dialysis to meet a hemodialysis Kt/V of at least 1.2 and a peritoneal dialysis weekly Kt/V of at least 1.7 or meet an alternative equivalent professionally-accepted clinical practice standard for adequacy of dialysis. This Standard is not met as evidenced by: 45020 Based on interviews, medical record review and document review, the facility failed to ensure two of four patients treatment sheets reviewed received the physician prescribed blood flow rate (BFR) and the dialysis flow rate (DFR) during treatment. (Patients #3 and #4). Findings include: Facility policies: The Patient Assessment and Monitoring policy read, the purpose of this policy is to provide guidance to staff on assessment and monitoring patients before, during and after treatment. Document machine parameters and safety checks every 30 minutes or more often as needed. Check prescribed blood flow is being achieved or reason is documented in medical record if unable to meet prescribed flow. Check dialysis flow rate setting is correct, and the prescribed flow is being delivered. The Unable to Achieve Prescribed Blood Flow Rate policy read, the purpose of this policy is to provide troubleshooting guidelines if unable to achieve prescribed blood flow rate (BFR). Achieving prescribed BFR is a critical parameter in achieving adequate treatment Kt/V. Staff, patient and/or care partner will recognize and report to the nurse in charge the inability to achieve prescribed blood flow rate. Notify Physician if unable to achieve prescribed blood flow rate. Document in patient’s treatment record what action taken to address the inadequate blood flow and if unable to resolve. The nurse shall document any physician orders. The Pre-Treatment Safety Checks policy read, verify the following elements by two staff members prior to treatment initiation: prescribed dialyzer and dialysate flow rate. 1. Direct patient care staff failed to ensure the hemodialysis machine settings for the BFR or DFR were adhered to as ordered. a. A review of Patient #3’s Treatment Data flowsheet from 9/18/24 revealed staff failed to follow the prescribed BFR of 425 milliliters (mL)/minute (min). On 9/18/24 Patient #3’s treatment started at 6:05 a.m. The BFR remained at 375 ml/min until 7:23 a.m., at which time the BFR was decreased to 325 ml/min until the treatment was terminated at 10:37 a.m. On 9/20/24 Patient #3’s Treatment Data flowsheet revealed treatment stated at 6:18 a.m., the BFR remained at 300 ml/min until treatment was terminated at 10:45 a.m. On 9/23/24 Patient #3’s Treatment Data flowsheet revealed treatment started at 6:14 a.m., the BFR remained at 300 ml/min until treatment was terminated at 10:46 a.m. On 9/25/24 Patient #3’s Treatment Data flowsheet revealed treatment started at 6:13 a.m., the BFR remained at 350 ml/min until 7:22 a.m., BFR was increased to 400 ml/min. At 7:58 a.m., the BFR was decreased to 370 ml/min, at 8:58 a.m., the BFR was decreased to 350 ml/min until treatment was terminated at 10:54 a.m. On 9/27/24 Patient #3’s Treatment Data flowsheet revealed treatment started at 6:57 a.m., the BFR remained at 350 ml/min until treatment was terminated at 10:15 a.m. On 9/30/24 Patient #3’s Treatment Data flowsheet revealed treatment started at 6:12 a.m. BFR remained at 320 ml/min until 7:22 a.m., when it was decreased to 310 ml/min. At 7:52 a.m., the BFR was increased to 325 ml/min, at 8:59 a.m., it was decreased to 300 ml/min until treatment was terminated at 10:42 a.m. There was no documented rationale for the changes to the prescribed BFR. b. A review of Patient #4’s Treatment Data flowsheet from 9/20/24 revealed staff failed to follow the prescribed BFR of 400 ml/min. On 9/20/24 Patient #4’s treatment started at 6:51 a.m., the BFR remained at 375 ml/min until treatment was terminated at 9:48 a.m. There was no documented rationale for the changes to the prescribed BFR. This was in contrast to the Patient Assessment and Monitoring policy which read, Check prescribed blood flow is being achieved or reason is documented in medical record if unable to meet prescribed flow. In addition, this was in contrast to the Unable to Achieve Prescribed Blood Flow Rate policy which read, document in patient’s treatment record what action was taken to address the inadequate blood flow and if unable to resolve. c. On 10/3/24 at 9:09 a.m. an interview was conducted with patient care technician (PCT) #5. PCT #5 stated it was important to follow the physician’s orders to ensure the patients received adequate treatment. PCT #5 stated BFR was a prescription and if the BFR was decreased, it was to be documented and the nurse was to be notified. PCT #5 stated if the BFR was decreased there was a risk the patient would not get adequate dialysis which could decrease the length of their life. d. On 10/3/24 at 9:38 a.m., an interview was conducted with registered nurse (RN) #3. RN #3 stated the BFR was the rate the patient’s blood went through the dialysis machine. RN #3 stated it was their expectation to be notified by the PCT if the BFR was decreased. RN #3 stated the BFR decrease was to be documented and PCTs were not to decrease the BFR without notifying the nurse. RN #3 stated if the BFR was decreased the patient’s blood would not be cleaned as well, which could cause the patient to get sick and possibly hospitalized.”