032610 Southeast 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 document review and interview, it was determined that the facility failed to ensure current staff and patient emergency contact lists were maintained in the Emergency Preparedness (EP) binder and fire/emergency box. Failure to update emergency preparedness staff contact lists in the communication plan may lead to harm to both patients and staff in an emergency. Findings include: The facility policy titled “Guidelines for Emergency Preparedness” requires: “...The facility must develop a communication plan...The plan includes....Create and maintain staff, patient and facility emergency information contact lists: ...Quarterly, the CM will review and update: The Emergency and Disaster Staff Contact Information Sheet...Disaster Patient Contact Information Sheet....” Review of the emergency fire box and emergency preparedness binder on 02/27/2024 and 02/28/2024 revealed the staff contact lists and patient information sheets were not up to date and did not reflect the names and contact information of staff currently employed and patients dialyzing at the facility. The Emergency Disaster Patient Contact List in the fire box was last updated on 09/14/2022. The list in the EP binder was dated 02/27/2024. Staff confirmed updating the list during the survey because it was not up to date. Employee #2 confirmed on 02/27/2024 that the staff contact list and patient information sheets in the emergency/fire box were not updated to reflect current staff and patients at the facility. Employee #1 confirmed on 02/28/2024 that the staff contact lists and patient information sheets in the emergency/fire box and emergency preparedness binder were not updated quarterly and as needed with changes.”

“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 document review and staff interview, it was determined the facility failed to participate in a full-scale exercise (FSE) that is community-based followed by an additional exercise on the opposite year that may include, but is not limited to the following: (A) A second FSE that is community-based or individual, facility-based. (B) A mock disaster drill. (C) A tabletop exercise. 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: The facility policy titled “Guidelines for Emergency Preparedness” requires: “...Community Based Drill...Annually, each facility MUST participate in a community-based disaster drill...Mock Table Top Drill...In addition to the community drills, facilities must select an event of high likelihood and conduct a table-top drill...Actual Emergency..If the facility is involved in an actual disaster, it can take the place of communicy-based drill or tabletop drill. The facility must have pictures and news articles to document the event....” During document review on 02/27/2024 and 02/28/2024 it was revealed the facility was missing documents proving participation in a full-scale exercise (FSE) that was community-based or facility-based exercise or table top drills alternating for the last two cycles (four years). A community-based drill and after-action report (AAR) dated 06/07/2023 was provided for review. No additional documented drills, AARs, or actual emergency for the last two cycles were provided. Employee #1 confirmed on 02/28/2024 that the facility was not able to provide proof of participation in exercises other than one community-based exercise in June 2023 as required for the last two cycles (four years).”

“IC-SANITARY ENVIRONMENT CFR(s): 494.30 The dialysis facility must provide and monitor a sanitary environment to minimize the transmission of infectious agents within and between the unit and any adjacent hospital or other public areas. This Standard is not met as evidenced by: 37489 Based on document review, observation, and interview, it was determined that the facility failed to ensure a clear separation of clean and dirty areas to store supplies and biohazardous medical waste which has the potential risk that contaminated clean supplied may be used in patient treatments. Findings include: The facility policy titled “Dialysis Precautions” requires: “...Clean Versus Dirty Areas...Clean area: An area designated for clean and unused equipment, supplies and medications...Dirty area: An area where this is a potential for contamination with blood or body fluids and areas where contaminated or used supplies, equipment, blood supplies or biohazard containers are stored or handled. clean areas should be clearly designated for the preparation and handling and storage of medications and unused supplies and equipment. clean areas should be clearly separated from dirty areas where used supplies, equipment or blood samples are handled or stored...Dialysis Precautions have been shown to reduce infectious disease transmission and are recommended by the Centers for Disease Control (CDC)....” Observation on 02/27/2024 revealed two storage areas on the treatment floor that combined both clean and dirty items. The first clean/dirty area located against the west wall near stations 1-8 contained the following: 1. a supply cart with (4) open boxes of BiBag bicarbonate bags and one open box of Naturalyte hemodialysis concentrate solution. 2. a supply cart with (2) boxes of Naturalyte hemodialysis concentrate solution, (2) boxes of Optiflux dialyzers, (2) boxes sodium chloride injection 1000 ml bags, (1) box of dialysis blood lines. 3. a large, approximately 44-gallon tub biohazard waste container with red liner on a container dolly. 4. shelving unit that contained an open container of acid concentrate wands immediately adjacent to and at the same level as the top of the biohazard bin, multiple gallon jugs of acid concentrate, (6) open boxes of paper and plastic tape, boxes of gloves, sterile gauze, 10 ml BD syringes, and additional blood lines. Three of the acid jugs were open at the top with wands in them. The biohazard waste bin was placed partially underneath one supply cart and the bin was touching the extra supply shelf with the acid wands hanging out and over the lid on the biohazardous waste container. The second clean/dirty area located against the west wall near stations 9-16 contained the following: 1. Hoyer lift 2. a large, approximately 44-gallon tub biohazard waste container with red liner on a container dolly. 3. a supply cart with multiple gallon acid concentrate jugs, two open acid jugs with wants in them, a box of 10 ml sterile syringes, and (3) open boxes of BiBag bicarbonate bags 4. a large, approximately 55-gallon trash bin 5. a supply cart with multiple gallon jugs of acid concentrate solution and an open container of acid wands hanging half in and half out of the container. The biohazard waste bin was placed between the Hoyer lift and a supply cart touching both and partially underneath the supply cart. RN #2 confirmed on 02/27/2024 that staff did not separate biohazardous waste bins from the clean dialysis supplies 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 nurses and dialysis technicians 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...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 EPA.gov website revealed: “...Using hand sanitizer kills pathogens on skin...hand sanitizers are regulated by the Food and Drug Administration (FDA)...A disinfectant is a substance, or mixture of substances that destroys or irreversibly inactivates bacteria, fungi and viruses, but not necessarily bacterial spores in the inanimate environment, such as on hard surfaces. Disinfectant products are often used in hospitals, medical facilities and/or households. EPA regulates disinfectants to ensure the pesticide meets specific standards before they can be used by the public....” Observation on 02/27/2024 revealed RN #4 pick up a stethoscope from off the nurses’ station computer desk and use it to assess a patient at station #7. RN #4 placed the stethoscope around his/her neck after use, left the station, and used it to assess the patient at station #6 without disinfecting the stethoscope between stations/patients. RN #4 placed the stethoscope around his/her neck after use at station #6, pumped hand sanitizer into his/her hand, then spread the hand sanitizer on the stethoscope bell. RN #4 then proceeded to use the stethoscope to assess a patient at station #3, placed the stethoscope around his/her neck, obtained a small isopropyl alcohol pad to clean the diaphragm only on the bell of the stethoscope while it hung around his/her neck. RN #4 then used the stethoscope to assess a patient at station #4 and did not disinfect the stethoscope before using it on the next patient at station #8. Observation on 02/27/2024 revealed PCT #9 pickup and use a stethoscope on the patient seated at station #6. PCT #9 placed the stethoscope around his/her neck after listening to the patient’s vascular access, continued with the needle cannulation process, initiated the patient’s treatment, and left the station to take care of another patient before placing the stethoscope on a work desk. The stethoscope was not disinfected after leaving the station and placing the stethoscope in the PCT workstation area. Observation on 02/27/2024 revealed PCT #18 use a stethoscope hanging around his/her neck to assess a patient’s vascular access at station #3. PCT #18 placed the stethoscope around his/her neck after use, initiated the patient’s treatment, and placed the stethoscope on a desk at his/her workstation without disinfecting the stethoscope. Observation on 02/27/2024 revealed RN #6 use his/her stethoscope on a patient at station #11. The nurse held the stethoscope in his/her hand until leaving the station, walked to the PCT workstation, used several pumps of “Germstar” hand sanitizer to wipe on his/her stethoscope. Neither a bleach solution nor disinfectant was used to disinfect the stethoscope. Employee #1 and 2 confirmed on 02/28/2024 that staff did not follow facility policy by disinfecting the entire surfaces of their stethoscopes with either bleach or an EPA registered disinfectant after leaving the dialysis stations and between patients.”

“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: 37489 Based on document review, observation, and interview, it was determined that the facility failed to ensure staff thoroughly cleaned and disinfected the dialysis station after use which has the potential risk of spread of infection between patients. Findings include: The facility policy titled “Cleaning and Disinfecting the Dialysis Station” requires: “...General Cleaning...The dialysis station could become contaminated with blood and other body fluids during treatment...Externally disinfect the dialysis machine with 1:100 bleach solutions after each dialysis treatment....” Observation on 02/27/2024 revealed PCT #9 cleaning and disinfecting the vacated dialysis station #5. PCT #9 failed to disinfect all surfaces of the machine with bleach solution, missing the YubiKey scanner device and wiring on the side of the dialysis machine, BP cuff basket and hand sanitizer bracket, the hangers on the IV pole, the top and sides of the sharps container, and missed sections of upholstery on the dialysis chair. Observation on 02/28/2024 at 1115 revealed PCT #17 cleaning and disinfecting the vacated dialysis station #12. PCT #17 failed to disinfect all surfaces of the machine with bleach solution missing the YubiKey scanner device and wiring on the side of the dialysis machine, BP cuff basket and hand sanitizer bracket, the IV pole hangers, the top and sides of the sharps container, and sections on the front and back of the machine. PCT #17 did not disinfect the BP cuff and tubing which was draped over the dialysis chair or disinfect the dirty dialysis chair and TV. PCT #17 proceeded to set up the partially disinfected dialysis station with clean supplies, “strung” the machine, primed the extracorporeal circuit with saline, and put the machine through pre-dialysis treatment testing. Residual pieces of one-inch medical paper tape typically used to secure fistula needles and bandages was noted on both sides of the dialysis machine, and two-inch paper tape was noted crisscrossing the back of the dialysis machine to hold on a section of the machine panel that was not secured with screws. PCT #13 was observed disinfecting the dialysis chair at the station 20 minutes after PCT #17 set up the machine at the station and put it in test. The television arm and brackets were not disinfected and residual grime, dust/lint, and a piece of paper tape remained on the TV. Employee #2 confirmed on 02/28/2024 that staff did not clean and disinfect all surfaces of the dialysis machine and clean off dirty residual tape prior to setting up treatments for subsequent patients as required.”

“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 document review, observation, and interview, it was determined that the facility failed to ensure: 1. staff labeled multi-dose medication vials when opened. Failure to label medication vials when opened and/or with a legible 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. 2. staff discarded expired multi-dose medication vials which has the potential risk of patients receiving an expired medication. 3. staff disinfected the diaphragm on a multi-dose vial of heparin solution prior to inserting a syringe and withdrawing medication which poses a risk that a contaminated medication will be administered to patients. Findings include: 1. 2. and 3. 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...Any open multi dose vials must be discarded 28 days after opening or per manufacturer’s expiration date...Infection control...The following steps must be taken to ensure infection control...Cleanse the diaphragm of a vial with alcohol prior to accessing the vial. If the vial is a multidose vial, cleanse the diaphragm with a new alcohol pad each time the vial is accessed with a needle using friction and 70% alcohol....” 1. Observation on 02/27/2024 revealed an open, 10 ml multi-dose vail of Lidocaine HCL for injection in the medication room. The vial had something written in ink pen on the side of the label that was scribbled and illegible. Observation on 02/27/2024 revealed an open, 30 ml multi-dose vial of Heparin Sodium injection at PCT pod desk #3 without any date documented on the vial when opened. RN #2 confirmed on 02/27/2024 that the writing on the side of the Lidocaine vial was illegible making it impossible to determine the appropriate discard date and that staff did not label vials when opened as required. 2. Observation on 02/27/2024 revealed an open, 50 ml multi-dose vial of Xylocaine HCL for injection. The vial was labeled with the date “02/09/2023.” RN #2 confirmed on 02/27/2024 that the expired vial was not discarded as required. 3. Observation on 02/28/2024 revealed PCT #17 withdrawing Heparin from a multi-dose vial without disinfecting the diaphragm with alcohol prior to inserting the needle. RN #2 confirmed on 02/28/2024 that PCT #17 did not disinfect the vial diaphragm with alcohol prior to withdrawing medication from the multi-dose vial as required by policy.”

“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 staff secured patient medications when not in use. Failure to secure medications when not in use has the potential risk patient will receive contaminated and/or tampered with medications. Findings include: The facility policy titled “Medication Preparation and Administration” requires: “...Securement...All medications will be kept in a locked cabinet except when in use....” Observation on 02/27/2024 revealed four PCT workstation desks with medication lockboxes on the desktops. Three of the four stations’ medication boxes were unlocked and two of the three unlocked boxes contained unsecured medications. The unlocked medication box at pod station #2 contained (5) unsecured pre-drawn medication syringes with heparin. The unlocked medication box at pod station #3 contained (4) 30 ml multi-dose vials of Heparin Sodium injection. RN #2 confirmed on 02/27/2024 that staff did not secure medications when not in use as required by policy.”

“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: 37489 Based on document review and interview, it was determined that the facility failed to ensure 1. biomedical technical staff accurately documented in dialysis equipment maintenance records and performed annual preventive maintenance as required in the manufacturer’s directions for use (DFU) which has the potential for patient injury or harm if dialysis machines are not maintained and normal operation is not verified; and 2. staff maintained the dialysis machine at station #11 in working order or pulled the machine from the treatment area for repairs. Cross reference V122. Findings include: 1. The document titled “2008T HEMODIALYSIS SYSTEM PREVENTATIVE MAINTENANCE PROCEDURES” requires: “...Preventive Maintenance for the 2008T Hemodialysis System...Scheduled maintenance is performed based on timed intervals or number of hours a machine is operated, whichever comes first. the time and hours intervals are as follows: ...Machines without...with Extended Life Pump Components...Six (6) months...Annually or after 4000 hours of operation...Failure to install, operate and maintain this equipment according to the manufacturer’s instructions may cause injury or death to the patient or the operator...Included in the Preventive Maintenance procedures are tests to verify normal machine operation....” The “FKC EQUIPMENT RECORD” for preventive maintenance and work orders for the last 12 months for dialysis machines was reviewed and found to have discrepancies in record keeping for tracking machine hours and corresponding maintenance, as well as preventive maintenance not performed in the required interval according to the manufacturer’s DFU. The following dialysis machine records contained inaccurate documentation of hours in operation and that preventive maintenance was not performed within the manufacturer’s DFU after 4000 hours of operation. Dialysis machine 6T0S-160481 07/17/2023: clock hours 21,836 Annual PM 01/15/2024: clock hours (NOT DOCUMENTED) Annual PM 01/18/2024: clock hours 26,196 Diasafe Dialysis machine 6T0S-160936 07/17/2023: clock hours 22,201 Annual PM 01/18/2024: clock hours 27,068 Annual PM The following dialysis machine records contained discrepancies in documentation of hours in operation. Dialysis machine 6T0S-161194 10/12/2023: clock hours 26,853 Diasafe 12/13/2023: clock hours 21,617 Diasafe 02/19/2024: clock hours 28,225 Diasafe Dialysis machine 6T0S-161337 03/09/2023: clock hours 23,306 Annual PM 03/09/2023: clock hours 16,538 Electrical leakage test Dialysis machine 7T0S-203174 04/24/2023: clock hours 18,725 Diasafe 06/22/2023: clock hours 21,028 Diasafe 08/28/2023: clock hours 20,332 Diasafe Dialysis machine 7T0S-203225 03/09/2023: clock hours 23,306 Electrical leakage test 03/09/2023: clock hours 16,528 Annual PM Biomed #21 confirmed on 02/28/2024 that equipment records were not accurate and machines were not serviced according to the manufacturer’s DFU. Additionally, that equipment logs used to track, monitor, and perform preventive maintenance for dialysis machines contained numerous inaccurate entries for machine clock hours which is used to determine preventive maintenance timeframes based on the manufacturer’s DFU. 2. Observation on 02/28/2024 revealed white paper medical tape wrapped around both sides and the back of the dialysis machine at station #11. Further observation revealed that 2” white paper medical tape was crisscrossed at the top of a rectangular panel on the back of the machine, along the bottom of the back panel, and down both the right and left sides of the panel to wrap around the side of the machine. The screws required to secure the panel in place were missing. A notice was printed on the back panel that stated “CAUTION” “RISK OF ELECTRIC SHOCK DO NOT REMOVE COVER, REFER SERVICING TO QUALIFIED SERVICE PERSONNEL.” Additionally, the computer keyboard on the front of the dialysis machine was noted to have plastic “micropore” medical tape. The tape covering broken keys to hold them in place was lifting up from all four sides. Biomed #21 confirmed on 02/28/2024 that the back panel was missing screws to secure it and that the dialysis machine was not maintained as required. RN #2 confirmed on 02/28/2024 that staff had used plastic medical tape to secure a large broken key on the dialysis machine instead of staff requesting repairs be made.”

“PR-RECEIVE SERVICES OUTLINED IN POC CFR(s): 494.70(a)(12) The patient has the right to- (12) Receive the necessary services outlined in the patient plan of care described in §494.90; This Standard is not met as evidenced by: 37489 Based on document review and interview, it was determined that the facility failed to ensure staff followed the Hemodialysis treatment order for estimated dry weight (EDW) for (2) of (4) patients (Patients #6 and 7) which has a potential risk of hypervolemia, increased workload of the heart and lungs, and adverse outcomes. Findings include: EDW: Estimated Dry Weight AW: Available Weight TWR: Target Weight Removal Treatment sheets were reviewed for the following dates and found that staff did not set the patients’ target weight removal to achieve the patient’s estimated dry weight. Patient #6 02/10/2024 EDW: 107.5 kg AW: 3.8 kg TWR: 3.25 kg The patient’s TWR was set to remove 1.75 kg after removal of 500 ml prime/rinse back saline given during treatment. The record did not contain documentation of rationale for not following the HD order to attain the prescribed EDW. The patient was discharged 0.8 kg over EDW. 02/13/2024 EDW: 107.5 kg AW: 4.5 kg TWR: 3.5 kg The patient’s TWR was set to remove 3 kg after removal of 500 ml prime/rinse back saline given during treatment. The record did not contain documentation of rationale for not following the HD order to attain the prescribed EDW. The patient was discharged 1.5 kg over EDW. 02/20/2024 EDW: 107.5 kg AW: 4.7 kg TWR: 3.5 kg The patient’s TWR was set to remove 3 kg after removal of 500 ml prime/rinse back saline given during treatment. The record did not contain documentation of rationale for not following the HD order to attain the prescribed EDW. The patient was discharged 1.3 kg over EDW. 02/24/2024 EDW: 107.5 kg AW: 5.2 kg TWR: 3.5 kg The patient’s TWR was set to remove 3 kg after removal of 500 ml prime/rinse back saline given during treatment. The record did not contain documentation of rationale for not following the HD order to attain the prescribed EDW. The patient was discharged 2 kg over EDW. Patient #7 02/21/2024 EDW: 141 kg AW: 5.6 kg TWR: 4.5 kg The patient’s TWR was set to remove 4 kg after removal of 500 ml prime/rinse back saline given during treatment. The record did not contain documentation of rationale for not following the HD order to attain the prescribed EDW. The patient was discharged 1.4 kg over EDW. 02/23/2024 EDW: 141 kg AW: 5.5 kg TWR: 4.5 kg The patient’s TWR was set to remove 4 kg after removal of 500 ml prime/rinse back saline given during treatment. The record did not contain documentation of rationale for not following the HD order to attain the prescribed EDW. The patient was discharged 0.9 kg over EDW. 02/26/2024 EDW: 141 kg AW: 6.8 kg TWR: 4 kg The patient’s TWR was set to remove 3.5 kg after removal of 500 ml prime/rinse back saline given during treatment. The record did not contain documentation of rationale for not following the HD order to attain the prescribed EDW. The patient was discharged 2.9 kg over EDW. The administrator and RN #2 confirmed on 02/28/2024 that nurses did not set Patients #6 and 7’s fluid removal goals according to the HD treatment order for EDW as listed above, nor did the medical record documentation contain rational not setting fluid removal goals to attain the prescribed dry weights.”

“PQ-STAFF LIC AS REQ/QUAL/DEMO COMPETENCY CFR(s): 494.140 All dialysis facility staff must meet the applicable scope of practice board and licensure requirements in effect in the State in which they are employed. The dialysis facility’s staff (employee or contractor) must meet the personnel qualifications and demonstrated competencies necessary to serve collectively the comprehensive needs of the patients. The dialysis facility’s staff must have the ability to demonstrate and sustain the skills needed to perform the specific duties of their positions. This Standard is not met as evidenced by: 37489 Based on personnel file review and interview, it was determined that the facility failed to ensure job specific required training and competencies were maintained for the facility administrator, social worker, dietitian, charge nurse, and two patient care technicians which has the potential risk that unqualified staff are providing services to patient which may cause harm. Findings include: FA #1, RN #2, PCT #7, PCT #15, MSW #19, and RD #20’s personnel files were reviewed on 02/28/2024 and found to have the following missing components. FA#1’s personnel file revealed in the Job Description for Facility Administrator that a Bachelor’s degree is required for the position. The personnel file did not contain an application, resume, or education that demonstrated the FA met the educational requirement. Additionally, the FA did not have documentation of current cardiopulmonary resuscitation (CPR) or an orientation. RN #2’s personnel file revealed that there was no CPR training conducted for 2022, no orientation, no TB baseline testing upon hire, no annual skills validation other than one water skills sign off in 2023, and the last “Clinical Annual Competency Exam for RN” was completed 11/21/2019. PCT #7’s personnel file revealed no annual skills validation for patient care technician had been completed since June 2022. PCT #15’s personnel file revealed no orientation, application, resume, or education that demonstrated the PCT met the requirements outlined in the job description. MSW #19’s personnel file revealed no current CPR training since 03/02/2022 and a mock code 06/21/2022, no orientation, and no job description which outlined the role requirements. RD#20’s personnel file revealed no current CPR training since 04/14/2021 and a mock code in January 2023. The administrator confirmed on 02/28/2024 that required components including training, skills validations, job descriptions, education, and orientations were missing from the aforementioned personnel files.”