032593 Granite Valley Dialysis (Fmc)

“Names and Contact Information CFR(s): §403.748(c)(1), §416.54(c)(1), §418.113(c)(1), §441.184(c)(1), §460.84(c)(1), §482.15(c)(1), §483.73(c)(1), §483.475(c)(1), §484.102(c)(1), §485.68(c)(1), §485.542(c)(1), §485.625(c)(1), §485.727(c)(1), §485.920(c)(1), §486.360(c)(1), §491.12(c)(1), §494.62(c)(1). [(c) The [facility must develop and maintain an emergency preparedness communication plan that complies with Federal, State and local laws and must be reviewed and updated at least every 2 years [annually for LTC facilities]. The communication plan must include all of the following:] (1) Names and contact information for the following: (i) Staff. (ii) Entities providing services under arrangement. (iii) Patients’ physicians (iv) Other [facilities]. (v) Volunteers. *[For Hospitals at §482.15(c) and CAHs at §485.625(c)] The communication plan must include all of the following: (1) Names and contact information for the following: (i) Staff. (ii) Entities providing services under arrangement. (iii) Patients’ physicians (iv) Other [hospitals and CAHs]. (v) Volunteers. *[For RNHCIs at §403.748(c):] The communication plan must include all of the following: (1) Names and contact information for the following: (i) Staff. (ii) Entities providing services under arrangement. (iii) Next of kin, guardian, or custodian. (iv) Other RNHCIs. (v) Volunteers. *[For ASCs at §416.45(c):] The communication plan must include all of the following: (1) Names and contact information for the following: (i) Staff. (ii) Entities providing services under arrangement. (iii) Patients’ physicians. (iv) Volunteers. *[For Hospices at §418.113(c):] The communication plan must include all of the following: (1) Names and contact information for the following: (i) Hospice employees. (ii) Entities providing services under arrangement. (iii) Patients’ physicians. (iv) Other hospices. *[For HHAs at §484.102(c):] The communication plan must include all of the following: (1) Names and contact information for the following: (i) Staff. (ii) Entities providing services under arrangement. (iii) Patients’ physicians. (iv) Volunteers. *[For OPOs at §486.360(c):] The communication plan must include all of the following: (2) Names and contact information for the following: (i) Staff. (ii) Entities providing services under arrangement. (iii) Volunteers. (iv) Other OPOs. (v) Transplant and donor hospitals in the OPO’s Donation Service Area (DSA). This Standard is not met as evidenced by: 37489 Based on review of the facility Emergency Plan (EP) record review, and staff interview, it was determined the facility failed to develop and maintain an emergency preparedness communication plan that complies with Federal, State and local laws and must include contact information related to staff, entities providing services under arrangement, next of kin, guardian or custodian, other facilities and volunteers be reviewed and updated at least annually. Failure to have an emergency preparedness communication plan that includes specific information could lead to harm to both patients and staff. Findings include: The facility’s Emergency Plan related to a communication plan that included contact information related to staff, entities providing services under arrangement, next of kin, guardian or custodian, other facilities and volunteers that was reviewed and at least updated annually was requested on 11/14/2023. The Emergency Plan did not include an emergency preparedness communication plan that included current contact information related to staff, entities providing services under arrangement, next of kin, guardian or custodian, other facilities and volunteers and was not reviewed and at least updated annually. The administrator confirmed on 11/14/2023 that the EP plan did not identify an emergency preparedness communication plan that included current contact information related to staff, entities providing services under arrangement, next of kin, guardian or custodian, other facilities and volunteers, and was not reviewed annually.”

“Emergency Officials Contact Information CFR(s): §403.748(c)(2), §416.54(c)(2), §418.113(c)(2), §441.184(c)(2), §460.84(c)(2), §482.15(c)(2), §483.73(c)(2), §483.475(c)(2), §484.102(c)(2), §485.68(c)(2), §485.542(c)(2), §485.625(c)(2), §485.727(c)(2), §485.920(c)(2), §486.360(c)(2), §491.12(c)(2), §494.62(c)(2). [(c) The [facility] must develop and maintain an emergency preparedness communication plan that complies with Federal, State and local laws and must be reviewed and updated at least every 2 years [annually for LTC facilities]. The communication plan must include all of the following: (2) Contact information for the following: (i) Federal, State, tribal, regional, and local emergency preparedness staff. (ii) Other sources of assistance. *[For LTC Facilities at §483.73(c):] (2) Contact information for the following: (i) Federal, State, tribal, regional, and local emergency preparedness staff. (ii) The State Licensing and Certification Agency. (iii) The Office of the State Long-Term Care Ombudsman. (iv) Other sources of assistance. *[For ICF/IIDs at §483.475(c):] (2) Contact information for the following: (i) Federal, State, tribal, regional, and local emergency preparedness staff. (ii) Other sources of assistance. (iii) The State Licensing and Certification Agency. (iv) The State Protection and Advocacy Agency. This Standard is not met as evidenced by: 37489 Based on review of the facility Emergency Plan (EP) record review, and staff interview, it was determined the facility failed to develop an current emergency officials contact list. Failure to have an emergency officials contact list during an emergency could lead to harm to both patients and staff if specific Federal, State, tribal, regional, and local emergency preparedness staff or other sources of assistance are not known if the need to contact them should arise Findings include: Document review on 11/14/2023 revealed the facility failed to maintain a current complete list of Federal, State, tribal, regional, local emergency preparedness staff and Other sources of assistance. The administrator confirmed on 11/14/2023 that the facility failed to maintain a current complete list of Federal, State, tribal, regional, local emergency preparedness staff and Other sources of assistance.”

“EP Testing Requirements CFR(s): §416.54(d)(2), §418.113(d)(2), §441.184(d)(2), §460.84(d)(2), §482.15(d)(2), §483.73(d)(2), §483.475(d)(2), §484.102(d)(2), §485.68(d)(2), §485.542(d)(2), §485.625(d)(2), §485.727(d)(2), §485.920(d)(2), §491.12(d)(2), §494.62(d)(2). *[For ASCs at §416.54, CORFs at §485.68, REHs at §485.542, OPO, “Organizations” under §485.727, CMHCs at §485.920, RHCs/FQHCs at §491.12, and ESRD Facilities at §494.62]: (2) Testing. The [facility] must conduct exercises to test the emergency plan annually. The [facility] must do all of the following: (i) Participate in a full-scale exercise that is community-based every 2 years; or (A) When a community-based exercise is not accessible, conduct a facility-based functional exercise every 2 years; or (B) If the [facility] experiences an actual natural or man-made emergency that requires activation of the emergency plan, the [facility] is exempt from engaging in its next required community-based or individual, facility-based functional exercise following the onset of the actual event. (ii) Conduct an additional exercise at least every 2 years, opposite the year the full-scale or functional exercise under paragraph (d)(2)(i) of this section is conducted, that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or individual, facility-based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the [facility’s] response to and maintain documentation of all drills, tabletop exercises, and emergency events, and revise the [facility’s] emergency plan, as needed. *[For Hospices at 418.113(d):] (2) Testing for hospices that provide care in the patient’s home. The hospice must conduct exercises to test the emergency plan at least annually. The hospice must do the following: (i) Participate in a full-scale exercise that is community based every 2 years; or (A) When a community based exercise is not accessible, conduct an individual facility based functional exercise every 2 years; or (B) If the hospice experiences a natural or man-made emergency that requires activation of the emergency plan, the hospital is exempt from engaging in its next required full scale community-based exercise or individual facility-based functional exercise following the onset of the emergency event. (ii) Conduct an additional exercise every 2 years, opposite the year the full-scale or functional exercise under paragraph (d)(2)(i) of this section is conducted, that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or a facility based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (3) Testing for hospices that provide inpatient care directly. The hospice must conduct exercises to test the emergency plan twice per year. The hospice must do the following: (i) Participate in an annual full-scale exercise that is community-based; or (A) When a community-based exercise is not accessible, conduct an annual individual facility-based functional exercise; or (B) If the hospice experiences a natural or man-made emergency that requires activation of the emergency plan, the hospice is exempt from engaging in its next required full-scale community based or facility-based functional exercise following the onset of the emergency event. (ii) Conduct an additional annual exercise that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or a facility based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop led by a facilitator that includes a group discussion using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the hospice’s response to and maintain documentation of all drills, tabletop exercises, and emergency events and revise the hospice’s emergency plan, as needed. *[For PRFTs at §441.184(d), Hospitals at §482.15(d), CAHs at §485.625(d):] (2) Testing. The [PRTF, Hospital, CAH] must conduct exercises to test the emergency plan twice per year. The [PRTF, Hospital, CAH] must do the following: (i) Participate in an annual full-scale exercise that is community-based; or (A) When a community-based exercise is not accessible, conduct an annual individual, facility-based functional exercise; or (B) If the [PRTF, Hospital, CAH] experiences an actual natural or man-made emergency that requires activation of the emergency plan, the [facility] is exempt from engaging in its next required full-scale community based or individual, facility-based functional exercise following the onset of the emergency event. (ii) Conduct an [additional] annual exercise or and that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or individual, a facility-based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the [facility’s] response to and maintain documentation of all drills, tabletop exercises, and emergency events and revise the [facility’s] emergency plan, as needed. *[For PACE at §460.84(d):] (2) Testing. The PACE organization must conduct exercises to test the emergency plan at least annually. The PACE organization must do the following: (i) Participate in an annual full-scale exercise that is community-based; or (A) When a community-based exercise is not accessible, conduct an annual individual, facility-based functional exercise; or (B) If the PACE experiences an actual natural or man-made emergency that requires activation of the emergency plan, the PACE is exempt from engaging in its next required full-scale community based or individual, facility-based functional exercise following the onset of the emergency event. (ii) Conduct an additional exercise every 2 years opposite the year the full-scale or functional exercise under paragraph (d)(2)(i) of this section is conducted that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or individual, a facility based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the PACE’s response to and maintain documentation of all drills, tabletop exercises, and emergency events and revise the PACE’s emergency plan, as needed. *[For LTC Facilities at §483.73(d):] (2) The [LTC facility] must conduct exercises to test the emergency plan at least twice per year, including unannounced staff drills using the emergency procedures. The [LTC facility, ICF/IID] must do the following: (i) Participate in an annual full-scale exercise that is community-based; or (A) When a community-based exercise is not accessible, conduct an annual individual, facility-based functional exercise. (B) If the [LTC facility] facility experiences an actual natural or man-made emergency that requires activation of the emergency plan, the LTC facility is exempt from engaging its next required a full-scale community-based or individual, facility-based functional exercise following the onset of the emergency event. (ii) Conduct an additional annual exercise that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or an individual, facility based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator includes a group discussion, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the [LTC facility] facility’s response to and maintain documentation of all drills, tabletop exercises, and emergency events, and revise the [LTC facility] facility’s emergency plan, as needed. *[For ICF/IIDs at §483.475(d)]: (2) Testing. The ICF/IID must conduct exercises to test the emergency plan at least twice per year. The ICF/IID must do the following: (i) Participate in an annual full-scale exercise that is community-based; or (A) When a community-based exercise is not accessible, conduct an annual individual, facility-based functional exercise; or. (B) If the ICF/IID experiences an actual natural or man-made emergency that requires activation of the emergency plan, the ICF/IID is exempt from engaging in its next required full-scale community-based or individual, facility-based functional exercise following the onset of the emergency event. (ii) Conduct an additional annual exercise that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or an individual, facility-based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the ICF/IID’s response to and maintain documentation of all drills, tabletop exercises, and emergency events, and revise the ICF/IID’s emergency plan, as needed. *[For HHAs at §484.102] (d)(2) Testing. The HHA must conduct exercises to test the emergency plan at least annually. The HHA must do the following: (i) Participate in a full-scale exercise that is community-based; or (A) When a community-based exercise is not accessible, conduct an annual individual, facility-based functional exercise every 2 years; or. (B) If the HHA experiences an actual natural or man-made emergency that requires activation of the emergency plan, the HHA is exempt from engaging in its next required full-scale community-based or individual, facility based functional exercise following the onset of the emergency event. (ii) Conduct an additional exercise every 2 years, opposite the year the full-scale or functional exercise under paragraph (d)(2)(i) of this section is conducted, that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or an individual, facility-based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the HHA’s response to and maintain documentation of all drills, tabletop exercises, and emergency events, and revise the HHA’s emergency plan, as needed. *[For OPOs at §486.360] (d)(2) Testing. The OPO must conduct exercises to test the emergency plan. The OPO must do the following: (i) Conduct a paper-based, tabletop exercise or workshop at least annually. A tabletop exercise is led by a facilitator and includes a group discussion, using a narrated, clinically relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. If the OPO experiences an actual natural or man-made emergency that requires activation of the emergency plan, the OPO is exempt from engaging in its next required testing exercise following the onset of the emergency event. (ii) Analyze the OPO’s response to and maintain documentation of all tabletop exercises, and emergency events, and revise the [RNHCI’s and OPO’s] emergency plan, as needed. *[ RNCHIs at §403.748]: (d)(2) Testing. The RNHCI must conduct exercises to test the emergency plan. The RNHCI must do the following: (i) Conduct a paper-based, tabletop exercise at least annually. A tabletop exercise is a group discussion led by a facilitator, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (ii) Analyze the RNHCI’s response to and maintain documentation of all tabletop exercises, and emergency events, and revise the RNHCI’s emergency plan, as needed. This Standard is not met as evidenced by: 37489 Based on review of the facility’s Emergency Preparedness Testing Requirements, record review and staff interview, it was determined the facility failed to participate in drills as required. Failure to participate in drills may lead to untrained staff in an emergency situation and may result in harm to the residents during an emergency. Findings include: Document review on 11/14/2023 revealed that the facility was missing documents proving participation in a full-scale exercise (FSE) that was community-based or a facility based exercise or table top drills for the last two years. The administrator confirmed during the exit interview that the facility was not able to locate proof of participation in a full-scale exercise that was community-based or a facility based exercise in the last two years.”

“IC-CDC MMWR 2001 CFR(s): 494.30(a) The facility must demonstrate that it follows standard infection control precautions by implementing- (1)(i) The recommendations (with the exception of screening for hepatitis C), found in “Recommendations for Preventing Transmission of Infections Among Chronic Hemodialysis Patients,” developed by the Centers for Disease Control and Prevention, Morbidity and Mortality Weekly Report, volume 50, number RR05, April 27, 2001, pages 18 to 28. 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 at 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. The recommendation found under section header “HBV-Infected Patients”, found on pages 27 and 28 of RR05 (“Recommendations for Preventing Transmission of Infections Among Chronic Hemodialysis Patients”), concerning isolation rooms, must be complied with by February 9, 2009. This Standard is not met as evidenced by: 37489 Based on document review, observation, and staff interview, it was determined that the facility failed to ensure staff aseptically disinfected (3) of (4) patients’ (Patients #8, 11, and 12) vascular access prior to cannulation with fistula needles. Failure to practice safe aseptic technique when cleansing and disinfecting a patient’s vascular access increases the risk for vascular access and blood stream infection. Findings include: The facility policy titled “Access Assessment and Cannulation” requires: “...Disinfect cannulation site as follows using...70% isopropyl alcohol pad: Using gentle friction, clean the access site beginning in the center and continuing outward 2 inches in a concentric circle for 30 seconds and allow to dry before cannulating...Povidone Iodine pad: Work outward 2 inches in a concentric circle using gentle friction for a minimum 30 seconds and allow to dry for 3 minutes before cannulating....” Observation on 11/13/2023 revealed Employee #9 disinfecting Patient #8’s vascular access for cannulation. Employee #9 used an isopropyl alcohol pad to disinfect the arterial cannulation site for 15 seconds, stopped and opened the fistula needle, then used a second alcohol pad to disinfect the site again for 7 seconds prior to cannulation with the fistula needle. Employee #9 then used an alcohol pad to disinfect the venous cannulation site for 15 seconds prior to inserting the venous fistula needle. Observation on 11/14/2023 revealed Employee #10 disinfecting Patient #11’s vascular access for cannulation. Employee #10 used a povidone iodine pad to disinfect the arterial cannulation site for 5 seconds, waited 45 seconds for the iodine to dry then cannulated with the arterial fistula needle. Employee #10 then used a second iodine pad to disinfect the venous cannulation site for 5 seconds, waited 30 seconds for the iodine to dry then cannulated with the venous fistula needle. Observation on 11/14/2023 revealed Employee #10 disinfecting Patient #12’s vascular access for cannulation. Employee #10 used an isopropyl alcohol pad to disinfect the arterial cannulation site for 4 seconds then immediately cannulated with the arterial fistula needle. Employee #10 used a second alcohol pad to disinfect the venous cannulation site for 4 seconds then immediately cannulated with the venous fistula needle. Employee #1 confirmed on 11/14/2023 that staff did not apply alcohol and povidone iodine for the appropriate amount of time or allow the iodine to dry for the required timeframe when disinfecting patients’ vascular access for cannulation as required by facility policy.”

“IC-IF TO STATION=DISP/DEDICATE OR DISINFECT CFR(s): 494.30(a)(1)(i) Items taken into the dialysis station should either be disposed of, dedicated for use only on a single patient, or cleaned and disinfected before being taken to a common clean area or used on another patient. -- Nondisposable items that cannot be cleaned and disinfected (e.g., adhesive tape, cloth covered blood pressure cuffs) should be dedicated for use only on a single patient. -- Unused medications (including multiple dose vials containing diluents) or supplies (syringes, alcohol swabs, etc.) taken to the patient’s station should be used only for that patient and should not be returned to a common clean area or used on other patients. This Standard is not met as evidenced by: 37489 Based on document review, observation, and interview, it was determined that the facility failed to ensure staff cleaned and disinfected their stethoscope between and after use on multiple patients which poses a potential risk of increased infection for patients through contact transmission and cross contamination of pathogenic organisms that may be harbored on the dirty stethoscope. Findings include: The facility policy titled “Cleaning and Disinfecting the Dialysis Station” requires: “...The Centers for Medicare and Medicaid Services (CMS) has regulations that in order to prevent cross contamination, a dialysis station must be cleaned and disinfected between dialysis patients. The chair and dialysis equipment are used by multiple patients during a treatment day and it is critical that these items be thoroughly cleaned and disinfected between used...Also, the nature of dialysis treatments with frequent exposure to blood and body fluids, close proximity of patients and staff, and the immunocompromised status of dialysis patients make dialysis a high-risk area for spreading infectious disease...Dialysis station...Area including the dialysis machine, chair/bed and other reusable equipment or supplies utilized during dialysis treatment...General Cleaning...After use, any non-disposable equipment and supplies brought into the dialysis station (ex. Stethoscope) must be disinfected with 1:100 bleach or EPA registered disinfectant before being removed from the dialysis station....” The facility policy titled “Access Assessment and Cannulation” requires: “...Assessment of Vascular Access...LISTEN...Bruit high pitch/whistle...Document in treatment record...Staff...who have been trained to auscultate vascular accesses should listen to the entire length of the access for changes in the sound of the bruit...Clean stethoscope after assessing a patient....” Observation on 11/13/2023 revealed Employees #7, 9, and 11 use their stethoscopes on multiple patients at multiple dialysis stations without disinfecting their stethoscope. The stethoscopes were used to listen to heart and lung sounds as well as auscultate vascular accesses. Observation on 11/14/2023 revealed Employee #21 use his/her stethoscope to assess a patient at Station #7, leave the station, and use a single alcohol pad to partially clean the diaphragm of the stethoscope but did not disinfect the entire stethoscope. Observation on 11/14/2023 revealed Employee #9 and 11 use their stethoscopes to access multiple patients’ vascular access without disinfecting the stethoscopes after use. Employee #1 confirmed on 11/14/2023 that staff did not disinfect their stethoscopes as required by facility policy.”

“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: 37489 Based on observation, manufacturer’s recommendations, and interview, it was determined that the facility failed to ensure: 1. staff appropriately labeled multi-dose medication vials when opened. Failure to label medication vials when opened with an expiration date prevents staff from knowing when to discard the vial which increases the risk a patient will receive a medication that is no longer stable, and that may be contaminated due to reduction of preservative efficacy as well as an increased exposure to pathogens from accessing a vial multiple times; and 2. staff appropriately store open multi-dose vial of Doxercalciferol which has the potential risk of a patient receiving an unstable medication. Findings include: 1. The Epogen manufacturer’s package insert requires: “...Throw away multiple-dose vials of Epogen no later than 21 days from the first day that you put a needle into the vial....” The facility policy titled “Medication Preparation and Administration” requires: “...Labeling vials...When preparing medications if the vial is not used immediately in its entirety, the nurse...must place the date and time the vial was opened on the medication label along with their initials. Note: To ensure all open vials are properly marked, the nurse must never walk away from an opened multi-dose vial without writing the date and time the vial was opened....” Observation on 11/13/2023 revealed an open vial of Epogen that was not labeled and dated in the medication refrigerator. Employees #7 and 21 confirmed on 11/13/2023 that the open multi-dose Epogen vial was not dated and labeled as required by facility policy. 2. The Doxercalciferol manufacturer’s instructions requires: “...Opened vials: Store for up to 3 days at 2° to 8°C (36° to 46°F)....” Observation on 11/03/2023 revealed an open multi-dose vial of Doxercalciferol stored in a medication cabinet at room temperature. Employees #7 and 21 confirmed on 11/13/2023 that open vials of Doxercalciferol are not stored at 2° to 8°C (36° to 46°F) as required by the manufacturer.”

“IC-STAFF EDUCATION-CATHETERS/CATHETER CARE CFR(s): 494.30(a)(2) Recommendations for Placement of Intravascular Catheters in Adults and Children I. Health care worker education and training A. Educate health-care workers regarding the ... appropriate infection control measures to prevent intravascular catheter-related infections. B. Assess knowledge of and adherence to guidelines periodically for all persons who manage intravascular catheters. II. Surveillance A. Monitor the catheter sites visually of individual patients. If patients have tenderness at the insertion site, fever without obvious source, or other manifestations suggesting local or BSI [blood stream infection], the dressing should be removed to allow thorough examination of the site. Central Venous Catheters, Including PICCs, Hemodialysis, and Pulmonary Artery Catheters in Adult and Pediatric Patients. VI. Catheter and catheter-site care B. Antibiotic lock solutions: Do not routinely use antibiotic lock solutions to prevent CRBSI [catheter related blood stream infections]. This Standard is not met as evidenced by: 37489 Based on review of policy and procedure, observation, and interview, it was determined that the facility failed to ensure staff applied skin disinfectant to a CVC (central venous catheter) exit site according to policy for (1) of (1) patient (Patient #14) which has a potential risk for adverse outcomes and increased infection. Findings include: The facility policy titled “Changing the Catheter Dressing Procedure” requires: “...If using ExSept Plus: Using gentle friction, use one saturated 4x4 to disinfect the access site beginning in the center and continuing outward 2 inches in a concentric circle for 30 seconds. Discard and repeat with a second 4x4. Allow to dry at least 2 minutes...apply a dressing to the exit site....” Observation on 11/14/2023 revealed Employee #11 performing CVC dressing change for Patient #14. Employee #11 used four ExSept soaked 2x2 gauze for 15 seconds each in concentric circles around the patient’s CVC exit site then allowed the disinfectant to dry for 1 minute and 20 seconds before placing a new CVC dressing. Employee #1 confirmed on 11/14/2023 that Employee #11 did not apply and allow the CVC exit site disinfectant to dry for the required time prior to placing a new CVC dressing for Patient #14’s catheter as required by facility policy.”

“MIXING SYSTEMS-LABELING CFR(s): 494.40(a) 5.4.4.1 Mixing systems: labeling Labeling strategies should permit positive identification by anyone using the contents of mixing tanks, bulk storage/dispensing tanks, and small containers intended for use with a single hemodialysis machine. Mixing tanks: Prior to batch preparation, a label should be affixed to the mixing tank that includes the date of preparation and the chemical composition or formulation of the concentrate being prepared. This labeling should remain on the mixing tank until the tank has been emptied. Bulk storage/dispensing tanks: These tanks should be permanently labeled to identify the chemical composition or formulation of their contents. Concentrate jugs: At a minimum, concentrate jugs should be labeled with sufficient information to differentiate the contents from other concentrate formulations used at the facility. This Standard is not met as evidenced by: 37489 Based on document review, observation, and interview, it was determined that the facility failed to ensure staff appropriately labeled the acid concentrate mixer with the contents of the mixer which has the potential risk of staff being unable to identify the contents, maximum storage times, and other critical information related to a product used in the delivery of dialysis treatments to patients. Findings include: The facility policy titled “Concentrate Labeling Requirements” requires: “...Policy Temporary Labeling (Incenter, Inpatient)...When a mix tank contains a solution, a label identifying the solution must be conspicuously displayed on the tank and must remain until the mix tank is emptied...Mix tank labeling must include: contents identification. For example, “Bicarb”, “Acid”, “RO Water” or “Disinfectant”...Chemical composition or formulation of concentrate...concentrate family with appropriate symbol. Example: 45x...Catalog number of product...Date and time of mixing....” Observation on 10/04/2023 revealed that the Dry Acid Dissolution Unit in the water room was filled with a liquid solution. The DADU was not labeled with the contents of the mixer. Employees #17 confirmed on 11/13/2023 that solution contained in the acid mixer had not been labeled as required by facility policy to properly identify the contents of the mixer.”

“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: 37489 Based on document review, observation, and staff interview, it was determined that the facility failed to ensure: 1. staff discarded expired oral patient medications; 2. staff secured patient medications when not in use; and 3. staff discarded expired patient treatment supplies. Failure to discard expired medications and secure medications when not in use has the potential risk patient will receive unstable, ineffective, contaminated, and/or tampered with medications and supplies. Findings include: 1. and 2. The facility policy titled “Medication Preparation and Administration” requires: “...Monitoring Expired Medications...Expiration dates for all stored medications are to be monitored on a monthly basis. Expired medications are to be discarded via Fresenius Kidney Care off-site return program or in accordance with local and/or state law...Securement...All medications will be kept in a locked cabinet except when in use....” 1. Observation on 11/13/2023 revealed (35) bottles of oral Calcitriol capsules 0.25 mcg expired 10/2023 in an unlocked medication cabinet at the medication preparation station. Employee #1 and 21 confirmed that the expired medication was not discarded as required by facility policy. 2. Observation on 11/13/2023 revealed four unlocked cabinets at the nurse’s stations. (3) of the (4) cabinets contained various oral and injectable medications for patient use. The medications were not secured when not in use by staff. Employees #7 and 21 confirmed on 11/13/2023 that the medication cabinets containing patient medications were not secured when not in use by staff as required by policy. 3. Observation on 11/13/2023 revealed the following expired supplies: Code Cart 4 - 10 cc syringes expired on 04/30/2023 4 - 18 g needles expired on 09/30/2022 5 - 18 g needles expired on 05/31/2023 5 - 21 g needles expired on 02/2021 2- 15 g x 1 1/4-inch WingEater Safety AV fistula needles Lab 1 - vacutainer blood collection set expired 06/30/2023 1 - green top lab tube expired 01/31/2023 1 - BBL Culture Swab expired 08/31/2023 6 - opened 10 cc syringes mixed in a bin of unopened syringes 1 - open 1 ml syringe in a bin of unopened syringes Employees #1, 2, and 3 confirmed on 11/14/2023 that supplies were not discarded as required upon expiration.”

“PA-ASSESS CURRENT HEALTH STATUS/COMORBIDS CFR(s): 494.80(a)(1) The patient’s comprehensive assessment must include, but is not limited to, the following: (1) Evaluation of current health status and medical condition, including co-morbid conditions. This Standard is not met as evidenced by: 37489 Based on review of policy and procedure, medical records, and interview, it was determined that the facility failed to ensure nursing staff recognized abnormal findings pre, intra, and post-treatment and documented an assessment and/or intervention if necessary for abnormal heart rate for (2) of (2) patients (Patients #7 and 10). Failure to conduct nursing assessment and follow up poses a potential risk to patients for adverse outcomes while receiving dialysis treatment if there is not adequate oversight and care provided by the registered nurse. Findings include: The facility policy titled “Patient Assessment and Monitoring” requires: “...The Registered Nurse will assess/re-assess any findings addressed pre or during treatment as needed...Pre-Treatment...Pulse...Verify pulses manually if automated readings display below 60 or greater than 100 beats per minute...During nursing rounds, the Registered Nurse will review the data collected above and assess the following parameters as needed: ...Heart sounds...Listen for: Rate...Document findings and interventions in the medical record...During Treatment...Pulse...Verify pulses manually if automated readings display below 60 or greater than 100 beats per minute...Document any findings and interventions in the medical record...Post-Treatment...Heart sounds...The registered nurse will assess/re-assess post treatment...Document findings in the patient’s record....” Patient #7 10/23/2023 The treatment sheet dated 10/23/2023 revealed the patient had a pretreatment heart rate (HR) of 59 beats per minute (BPM). Additionally, the following intra-dialytic pulse rates were documented: 1016 HR 57 1021 HR 58 1041 HR 54 1103 HR 53 1242 HR 58 1301 HR 42 The medical record contained no documentation of recognition, manual verification of the abnormal pulse rate, and assessment/re-assessment by the RN. 11/03/2023 The treatment sheet dated 11/03/2023 revealed the following intra-dialytic pulse rates: 1039 HR 50 1039 HR 50 1043 HR 50 1101 HR 51 1244 HR 59 1301 HR 59 The medical record contained no documentation of recognition, manual verification of the abnormal pulse rate, and assessment/re-assessment by the RN. 11/08/2023 The treatment sheet dated 11/03/2023 revealed the following intra-dialytic pulse rates: 1025 HR 59 1102 HR 59 1220 HR 59 1302 HR 56 1321 HR 58 1327 HR 58 The medical record contained no documentation of recognition, manual verification of the abnormal pulse rate, and assessment/re-assessment by the RN. 11/10/2023 The treatment sheet dated 10/23/2023 revealed the patient had a pretreatment heart rate HR 57. Additionally, the following intra-dialytic pulse rates were documented: 1035 HR 53 1041 HR 50 1103 HR 50 1124 HR 57 1201 HR 55 1302 HR 56 1322 HR 55 1338 HR 56 Post treatment HR 58 The medical record contained no documentation of recognition, manual verification of the abnormal pulse rate, and assessment/re-assessment by the RN. Patient #10 10/31/2023 The treatment sheet dated 10/31/2023 revealed the patient had a pretreatment heart rate (HR) of 100 beats per minute (BPM). Additionally, the following intra-dialytic pulse rates were documented: 0737 HR 100 0743 HR 100 1001 HR 105 1021 HR 106 1043 HR 104 The medical record contained no documentation of recognition, manual verification of the abnormal pulse rate, and assessment/re-assessment by the RN. 11/02/2023 The treatment sheet dated 11/02/2023 revealed the patient had a pretreatment HR 105. Additionally, the following intra-dialytic pulse rates were documented: 0706 HR 101 0722 HR 101 0941 HR 100 The medical record contained no documentation of recognition, manual verification of the abnormal pulse rate, and assessment/re-assessment by the RN. 11/04/2023 The treatment sheet dated 11/04/2023 revealed the following intra-dialytic pulse rates: 0923 HR 100 1029 HR 101 The medical record contained no documentation of recognition, manual verification of the abnormal pulse rate, and assessment/re-assessment by the RN. 11/07/2023 The treatment sheet dated 11/07/2023 revealed the patient had a pretreatment HR 102. Additionally, the following intra-dialytic pulse rates were documented: 0705 HR 113 0903 HR 101 The medical record contained no documentation of recognition, manual verification of the abnormal pulse rate, and assessment/re-assessment by the RN. 11/09/2023 The treatment sheet dated 11/09/2023 revealed the following intra-dialytic pulse rates: 0742 HR 106 0821 HR 100 The medical record contained no documentation of recognition, manual verification of the abnormal pulse rate, and assessment/re-assessment by the RN. 11/11/2023 The treatment sheet dated 11/11/2023 revealed the following intra-dialytic pulse rates: 0744 HR 100 0942 HR 106 1003 HR 101 1025 HR 103 The medical record contained no documentation of recognition, manual verification of the abnormal pulse rate, and assessment/re-assessment by the RN. Employees # 1, 2, and 3 confirmed on 11/14/2023 that the registered nurse did not acknowledge, manually verify, and document findings in the medical record for abnormally low and high pulse rates for Patients #7 and 10 as required by facility policy.”