Fmc Dialysis Services Bellflower

“Dialysis Emergency Equipment CFR(s): §494.62(b)(9) Condition for Coverage: [(b) Policies and procedures. The dialysis facility must develop and implement emergency preparedness policies and procedures, based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, and the communication plan at paragraph (c) of this section. The policies and procedures must be reviewed and updated at least every 2 years. At a minimum, the policies and procedures must address the following:] (9) A process by which the staff can confirm that emergency equipment, including, but not limited to, oxygen, airways, suction, defibrillator or automated external defibrillator, artificial resuscitator, and emergency drugs, are on the premises at all times and immediately available. This Standard is not met as evidenced by: 22198 Based observation, interviews, review of facility policy, and Emergency Evacuation checklist reviews, the facility failed to have a clearly defined system for monitoring Emergency Evacuation supplies for two of two Emergency Evacuation boxes located at the facility. This failure to have a clearly defined system in place for monitoring and managing emergency supplies has the potential to negatively affect all 160 patients receiving dialysis in this facility. Findings include: During an interview and observation on 11/29/23 at 10:20 AM Registered Nurse (RN) 22 while opening the Emergency Evacuation box confirmed there was no list to identify the content of the two Emergency Evacuation boxes and confirmed there was no staff or patient emergency contact information. Review of the first printed copy of the facility Emergency Evacuation list titled, “59064 - Emergency Box Contents Log Incenter - Monthly v2”, print date 11/27/23, provided by RN22, revealed, numeric values for the number of supplies required in each emergency supply category had been crossed off and lower handwritten values were entered for the month of November. Review of the second copy of the facilities Emergency Evacuation list titled “Emergency Box Contents” dated 11/07/18 revealed, had missing numeric value entered for the number of saline bags required and the number of Intravenous (IV) administration sets. During an interview on 11/29/23 at 11:00 AM the Facility Administrator confirmed the missing number of IV bags and IV administration sets required in the two Emergency Evacuation boxes was missing from the form. The Facility Administrator confirmed the facility must maintain emergency evacuation supplies enough to cover one full shift even though it was not defined in their current “Emergency Medications, Equipment and Supplies” policy. The Facility Administrator stated the company wants to be paperless and have everything done electronically but confirmed, the current electronic Emergency Evacuation list contained additional information that made the list four pages long with content not applicable to the Emergency Evacuation checklist. During a follow up interview on 11/29/23 at 2:30 PM, the Facility Administrator confirmed the two Emergency Evacuation boxes failed to include all patient and staff emergency contact information, and an itemized log with a clear and accurate list of the contents. Review of the facility’s policy titled, “Emergency Medications, Equipment and Supplies” dated 05/01/23, revealed, “An emergency evacuation box must: Be available to grab in case of fire or immediate need to evacuate the clinic. Contain all patient and staff emergency contact information. Be checked monthly or after use for contents, expiration dates and cleanliness. All staff must know the location of the evacuation box and who is responsible to grab it during an emergency evacuation. An itemized log must be kept indicating the contents and expiration dates of contents. Items approaching expiration must be reordered and replaced prior to the actual expiration date”.”

“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: 28297 Based on interview, review of the facility’s Disaster Preparedness binder, and policy review, the facility failed to provide evidence that a community based, or tabletop exercise was performed as required. The failure to perform emergency preparedness training had the potential for staff to not be properly prepared in the event of a disaster and this could affect the 160 in-center patients. Findings include: Review of the Disaster Preparedness binder revealed no community-based exercise had been completed since October 2021 and no facility-based exercise had been completed since August 2021. During an interview on 11/29/23 at 9:45 AM the Director of Operations stated the facility just missed or forgot about the community-based exercise. Review of the facility policy titled, “Guidelines for Disaster Preparedness,” revised 07/23/23 revealed the following: “Community Based Drill Annually, each facility MUST participate in a community-based disaster drill. If unable to participate, document who you contacted in the community and why the clinic was unable to participate on the Facility Specific Disaster Safety Plan form. If the EOC or similar agency has not performed a community-based drill, or it was missed for a particular year, the DO should coordinate a dialysis facility area-based drill. ...Mock Tabletop Drills- In addition to the community drills, facilities must select an event of high likelihood and conduct a table-top drill. It is recommended a different drill be completed annually.””

“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: 22198 Based on observations, interview, and policy review, the facility failed to ensure patients performed hand hygiene (sanitizing with an alcohol-based hand rub or washing with soap and water) after removing a glove after assisting with holding the dialysis access site to achieve hemostasis (stop bleeding). The facility further failed to ensure staff performed hand hygiene between glove changes for two of two observation days. Failure to perform hand hygiene provided a mode of cross contamination with the potential spread of infection which could negatively impact the 160 patients receiving incenter hemodialysis treatments at this facility. Findings include: During an observation on 11/27/23 at 9:39 AM in the Isolation (ISO) room, during care dialysis initiation, Patient Care Technician (PCT) 11 missed opportunities to perform hand hygiene between gloves changes: after entering data on the computer and changing gloves, after cleaning the access site and changing gloves, after inserting the needles and changing gloves. During an interview on 11/27/23 at 10:00 AM PCT 11 confirmed he/she had missed opportunities to perform hand hygiene in between glove changes. During an observation on 11/28/23 at 9:11 AM, PCT19 failed to wash his/her hands after glove changes between working in Stations #20 and donned gloves and started working in Station #17. During an interview on 11/28/23 at 9:11 AM, PCT19 confirmed hand hygiene should be performed between gloves changes and between dialysis stations. Review of the facility’s policy titled, “Hand Hygiene” dated 11/06/23 revealed, “Hand hygiene includes either washing hands with soap and water or using a waterless alcohol-based antiseptic hand rub with 60-90% alcohol content. Drying effects of alcohol can be counteracted by addition of emollient or humectants, e.g., l-3o/o glycerol. The table below identifies when hands shall be washed specifically with soap and water or when alcohol-based hand rubs can be used: ... Immediately after removing gloves”.”

“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: 22198 Based on observation, interview, and policy review, the facility failed to ensure staff were not taking their personal cell phones into the dialysis station and placing them in clean supply drawers with dialysis supplies. This failure in Infection Control practices has the potential to negatively affect 160 in-center dialysis patients being treated at this facility. Findings include: During an interview and observation on 11/28/23 at 9:55 AM on the dialysis treatment floor by the nurse’s station, a cell phone was found in a clean supply drawer with sterile syringes. Patient Care Technician (PCT) 17, came over during the observation and took the cell phone and case from the drawer. PCT17 confirmed the cell phone belonged to him/her. During an observation on 11/28/23 at 10:08 AM while on the dialysis treatment floor in POD 3, a cell phone was found in a clean supply drawer with sterile syringes and blue barrier pads. The phone was identified by a staff member as belonging to PCT18. During an interview on 11/28/23 at 10:08 AM Clinical Manager (CM) 9 confirmed the personal cell phone was in the clean supply drawer and should not be there. CM9 stated that personal cell phones should not be on the dialysis floor. During an interview on 11/29/23 at 10:00 AM and review of the above findings, the Director of Operations confirmed personal cell phones should not be put into a clean supply drawer because facility policy prohibits personal cell phone on the dialysis treatment floor. Review of the facility policy titled, “Dialysis Precautions” dated 01/04/12, revealed, “Clean Area: An area designated for clean and unused equipment, supplies and medication. Clean areas should be designated for the preparation and handling and storage of medication and unused supplies and equipment. Review of the facility policy titled, “Use of Portable Electronic Communication Devices”, dated 12/15/20, revealed, “Patient Care Employees are prohibited from carrying cell phones and portable communication devices into patient care areas”.”

“IC-CLEAN/DIRTY;MED PREP AREA;NO COMMON CARTS CFR(s): 494.30(a)(1)(i) Clean areas should be clearly designated for the preparation, handling and storage of medications and unused supplies and equipment. Clean areas should be clearly separated from contaminated areas where used supplies and equipment are handled. Do not handle and store medications or clean supplies in the same or an adjacent area to that where used equipment or blood samples are handled. When multiple dose medication vials are used (including vials containing diluents), prepare individual patient doses in a clean (centralized) area away from dialysis stations and deliver separately to each patient. Do not carry multiple dose medication vials from station to station. Do not use common medication carts to deliver medications to patients. If trays are used to deliver medications to individual patients, they must be cleaned between patients. This Standard is not met as evidenced by: 22198 Based on observation, interview, and policy reviews, the facility failed to ensure for two of two observation days that stethoscopes, badges, and tap in fobs taken into the dialysis station were dedicated, disposed of, or disinfected. The failure to follow Infection Control standards and the facility’s Infection Control Policy has the potential for cross contamination and could negatively affect the wellbeing of 160 in-center dialysis patients. Findings include: 1.During an observation on 11/27/23 at 9:39 AM revealed Patient Care Technician (PCT) 11 was in the Isolation (ISO) room during initiation of dialysis with a Hepatitis B positive patient (P) P1 PCT11 reached into the front of his/her gown with a gloved hand and pulled out his/her name badge with an attached fob and laid it on the fob port of the dialysis machine to gain access to the machine computer. PCT11 then left the name badge and fob on the exterior of the gown while initiating dialysis. After completing initiation, PCT 11 removed his/her personal protective equipment (PPE) washed his/her hands, left the ISO room, and started working on the treatment floor in the buffer zone without cleaning the badge or fob. During an interview on 11/27/23 at 10:00 AM PCT11 confirmed the fob with his/her personal information to enter the dialysis machine computer was attached to his/her badge and it had remained hanging on the outside of his/her gown during initiation, and it had not been cleaned upon exiting the ISO room. 2.During an observation on 11/28/23 at 9:12 AM with Clinical Manager (CM) 9, PCT 17, PCT 19, PCT15, PCT16, PCT 20 all had badges hanging from the front of their gown and stethoscopes hanging around their neck moving between patient stations and Registered Nurse (RN) 23 had a stethoscope around his/her neck. RN23 was observed finishing initiating Central Venous Catheter Care and the stethoscope slide off one side of his/her neck, and she grabbed it to prevent it from falling on the floor with the gloves he/she used to initiate catheter care and put it back around his/her neck and then entered data on the dialysis machine computer. RN23 after finishing care left the dialysis station without cleaning his/her stethoscope. During an interview on 11/28/23 at 9:26 AM, CM9 confirmed the above observations. CM9 stated the staff observed wearing the stethoscopes around their necks, were their own personal stethoscopes, and they did not want to lose them. CM9 confirmed anything taken into the dialysis station needed to be dedicated disinfected or disposed of. CM9 confirmed the badges were not supposed to be worn on the exterior of the protective gown. During an interview with the Facility Administrator and Director of Operations on 11/28/23 at 2:45 PM while reviewing the above findings, confirmed there was no policy on the fob tap system to enter the dialysis machine computers, and would have to look into that. The Facility Administrator and Director of Operations confirmed that the policy required anything taken into the dialysis station needed to be dedicated disposable or disinfected. Review of the facility’s policy titled, “Cleaning and Disinfecting the Dialysis Station” dated 09/05/23, “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”.”

“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: 22198 Based on observation, interview, and policy review, the facility failed to ensure all environmental surfaces in the dialysis treatment stations were disinfected after each dialysis treatment, during two of two observation days. Failure to thoroughly disinfect all environmental surfaces in the dialysis treatment stations after each dialysis treatment, had the potential to serve as a vehicle for transmission of infectious disease and negatively impact the safety and wellbeing of the 160 in-center patients receiving dialysis treatments at this facility. Findings include: 1.During an interview and observation of dialysis station cleaning on 11/27/23 at 12:36 PM Patient Care Technician (PCT) 11, after removing the patient’s personal bag from the back counter, failed to clean the counter behind the dialysis station as a part of the dialysis station cleaning. PCT11 stated that he/she had not cleaned the countertop behind the dialysis chair and machine. 2.During an interview and observation of dialysis station cleaning on 11/28/23 at 9:38 AM PCT16, after removing the patient’s personal bag from the back counter, placed the used blood pressure cuff on the back counter and failed to clean the counter behind the dialysis station or the blood pressure cuff as a part of the dialysis station cleaning. PCT16 confirmed he/she had finished cleaning the dialysis station and was preparing supplies to set the dialysis station up for the next patient. PCT16 confirmed he/she had not cleaned the back countertop or the blood pressure cuff and should have. Review of the facility’s policy titled, “Cleaning and Disinfecting the Dialysis Station”, dated 09/05/23, revealed, “ 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 uses”.”

“IC-HBV-ISOLATION (EXISTING FACILITY) CFR(s): 494.30(a)(1)(i) Isolation of HBV+ Patients To isolate HBsAg positive patients, designate a separate room for their treatment. For existing units in which a separate room is not possible, HBsAg positive patients should be separated from HBsAg susceptible patients in an area removed from the mainstream of activity. This Standard is not met as evidenced by: 22198 Based on observation, interview, and policy review, the facility failed to ensure staff kept the isolation room door closed during critical dialysis times while treating hepatitis B positive patients. This had the potential for cross contamination and could affect all 160 in-center dialysis patients. Findings include: During an observation on 11/27/23 at 9:50 AM of the isolation room with a hepatitis B (HBV) positive patient, Patient Care Technician (PCT) 11 performed dialysis initiation with the isolation room door open. During an interview on 11/27/23 at 10:00 AM, PCT11 confirmed the isolation room door was not closed when he/she initiated dialysis. PCT11 stated the door was not usually closed unless it was the end of the day or there was no Hepatitis B positive patient in the facility. During an interview on 11/27/23 at 12:50 PM, the Facility Administrator confirmed the isolation room door should be closed when the potential for blood spirting or splattering was most likely to occur and confirmed that the door should be closed during initiation and termination. Review of the facility’s isolation room policy titled “Dialyzing Patients with Positive Hepatitis B Antigen (HBsAg+)” dated 11/06/23 revealed, “The separate room is required to have a door to contain any spurting of blood, body fluids, and other contaminates to prevent cross transmission. The door must be closed during times when blood spurting or spattering is possible. The walls must allow for visual monitoring of the patients unless a staff member is continually present in the room.””

“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: 22198 Based on observation, interview, review of manufacturer’s directions for use (DFU), and policy review, the facility failed to; 1.) follow the bloodline manufacturer’s DFU for three of three survey days during hemodialysis treatments by failing to ensure the arterial drip chamber fluid levels were at the manufacturer’s recommended directions for use (DFU) and: 2.) failed to remove expired supplies from immediate use. Failure to follow the manufacturer’s DFU and failure to remove expired supplies had the potential to negatively impact the safety and wellbeing of the 160 patients receiving in-center hemodialysis. Findings include: 1. Observations of drip chambers not following policy and manufacture’s DFU as follows: a. During an observation on 11/17/23 at 9:26 AM, the arterial drip chambers at Stations #31, #32, #28, #26, and #25 were less than 85 to 95% full. During an interview on 11/27/23 at 10:09 AM Patient Care Technician (PCT) 11 confirmed the arterial drip chambers were not filled to the correct level per manufactures DFU. During an interview on 11/27/23 at 10:10 AM Registered Nurse (RN) 8 confirmed that the arterial drip chambers were lower than the manufactures DFU. b. During an observation and interview on 11/27/23 at 10:15 AM, the arterial drip chambers at Stations #13 and #14 were one quarter full. PCT12 at the time of the observation, confirmed the arterial drip chambers were one quarter full and should be three-fourths full. c. During an observation and interview on 11/28/23 at 8:43 AM, the arterial drip chambers at Stations #8 and #2 were below the manufacturers DFU. PCT15 confirmed the arterial drip chambers at Stations #8 and #2 were not filled to the manufactures DFU. d. During an observation and interview on 11/28/23 at 9:06 AM blood was observed dripping from the top of the chamber to the bottom of the chamber, but no blood was observed in the chamber reservoir at Station #25. Clinical Manager (CM) 9 confirmed the drip chamber did not contain blood. CM9 confirmed the chamber was not filled per manufacturers DFU. Review of the manufactures DFU titled, “Combi Set True Flow Series” not dated, revealed, “Maintain fluid level in pre-pump arterial chamber at 85 to 95% full, post-pump arterial and venous chamber at 65% to 75% full.” Review of the facility’s policy titled, “Patient Assessment and Monitoring” dated, 05/01/23, revealed, “During Treatment:” every 30-minute assessment and monitoring required the following, “Observe and ensure that: ... Venous and arterial chambers are filled to the fill level.” 2. During an observation and interview on 11/28/23 at 9:26 AM, 21 - 17-gauge fistula needles were found in POD 3 in the immediate use supply cabinet in three different drawers with the manufacturers recommended expiration date of “11/23/23.” CM9 confirmed that in the immediate use drawers in POD3 there were 21 - 17-gauge fistula needles, that per manufactures DFU had the expiration date of 11/23/23. CM9 confirmed per the manufacturers recommended DFU the products were expired. a. During an observation and interview on 11/29/23 at 10:50 AM, a vial of Adrenaline 1 milligram (mg)/1 milliliter (ml) had the manufactures expiration date of 02/22. RN 7 confirmed per the manufacture’s DFU, the vial of Adrenaline expired 02/22 and should have been removed from immediate use medications.”

“PE-HD PTS IN VIEW DURING TREATMENTS CFR(s): 494.60(c)(4) Patients must be in view of staff during hemodialysis treatment to ensure patient safety, (video surveillance will not meet this requirement). This Standard is not met as evidenced by: 22198 Based on observation, interview, and policy review the facility failed to ensure that staff had visible access to patients and access sites (faces, needle insertion sites, and line connections) for one of two observation days. This had the potential for excessive blood loss from possible needle dislodgement, resulting in dire consequences such as severe hypotension (low blood pressure), hospitalization, blood transfusions, and death. This had the potential to affect all 160 in-center hemodialysis patients receiving care at the facility. Findings include: 1. During an observation on the dialysis treatment floor on 11/27/23 at 9:25 AM, patients at Station #2, #7 and #17 had their access sites covered. 2. During an observation on the dialysis treatment floor on 11/27/23 at 10:02 AM patients at Stations #12 and #25 had their access site covered. During an interview on 11/27/23 at 10:05 AM, with Patient (P)15 he/she was asked had he/she been educated about not covering his/her access or the rationale for always having the access visible. P15 stated, “he/she had not been educated, and was not aware of the rationale for always having the access visible.” 3. During an interview and observation on the dialysis treatment floor on 11/27/23 at 11:10 AM, revealed P16 at Station #4 had their access site covered. P16 confirmed he/she was not aware that his/her access site should not be covered. 4. During an observation on the dialysis treatment floor on 11/27/23 at 11:15 AM patients at Stations #7, #12, #19, #23, #24, and Station #34 had their access sites covered and at Station #34 a patient also had his/her face covered. During an interview on 11/27/23 at 12:50 PM and review of the covered accesses observed from 9:25 AM to 12:50 PM, the Facility Administrator confirmed that access sites should always be visible per policy. When asked specifically about Station #34 (face covered) the Facility Administrator stated, “they should have their eyes visible at all times”. Review of the facility’s policy titled, “Patient Assessment and Monitoring” dated 05/01/23, revealed, “Ensure each patient’s face is visible and uncovered ... Ensure access remains uncovered throughout the treatment.””

“PA-ASSESS B/P, FLUID MANAGEMENT NEEDS CFR(s): 494.80(a)(2) The patient’s comprehensive assessment must include, but is not limited to, the following: Blood pressure, and fluid management needs. This Standard is not met as evidenced by: 28297 Based on interview, record review, and policy review, the facility failed to ensure five of 15 sampled patients (Patient (P)1, P2, P3, P9 and P14) were monitored every 30 minutes as required. The failure to monitor patients every 30 minutes had the potential to not capture a potential adverse event in a timely manner and could affect all 160 in-center hemodialysis patients. Findings include: 1.Review of the medical record for P1 revealed the facility admitted the patient on 04/27/22 with a diagnosis including End Stage Renal Disease (ESRD). Review of six dialysis flow records for P1 from 11/15/23- 11/27/23 revealed on 11/22/23 the patients’ blood pressure was checked at 10:04 AM with a reading of 111/59 and was not checked again until 11:05 AM, with a reading of 144/72, one hour and one minute later. 2. Review of the medical record for P2 revealed the facility admitted the patient on 05/31/17 with diagnosis of ESRD. Review of six dialysis flow records for P2 from 11/15/23-11/27/23 revealed on 11/22/23 the patients’ blood pressure was checked at 5:29 AM with a reading of 129/61 and not checked again until 7:02 AM with a reading of 96/56, one hour and 33 minutes later. 3. Review of the medical record for P3 revealed the facility admitted the patient on 07/06/16 with diagnosis of ESRD. Review of six dialysis flow records for P3 from 11/14/23-11/25/23 revealed on 11/25/23 the patients’ blood pressure was checked at 3:31 PM with a reading of 117/67 and not checked again until 4:34 PM with a reading of 111/75, 1 hour and three minutes later. 4.Review of the medical record for P9 revealed the facility admitted the patient on 12/21/09 with diagnosis of ESRD. Review of six dialysis flow records for P9 from 11/07/23-11/25/23 revealed on 11/07/23 the patients’ blood pressure was checked at 12:03 PM with a reading of 118/51 and not checked again until 1:02 AM with a reading of 151/67, 59 minutes later. 5. Review of the medical record for P14 revealed the facility admitted the patient on 05/11/16 with diagnosis of ESRD. Review of six dialysis flow records for P14 from 11/14/23-11/24/23 revealed on 11/22/23 the patients’ blood pressure was checked at 2:39 PM with a reading of 121/51 and not checked again until 3:44 PM with a reading of 132/62, one hour and four minutes later. On 11/20/23 the patients’ blood pressure was checked at 12:21 PM with a reading of 178/75 and not checked again until 1:37 PM with a reading of 151/68, one hour and 16 minutes later. During an interview on 11/29/23 at 12:40 PM, Registered Nurse (RN) 7 confirmed the above flowsheets were missing blood pressure checks every 30 minutes as required and that staff should be checking the patients’ blood pressure every 30 minutes to ensure the patient was stable. Review of the facility’s policy titled, “Patient Assessment and Monitoring” revised 05/01/23 revealed the following: “Monitoring During Treatment: Obtain blood pressure and pulse rate every 30 minutes or more as needed but not to exceed 45 minutes or per state regulations. Document machine parameters and safety checks every 30 minutes or more often as needed but not to exceed 45 minutes or per state regulations.””

“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: 28297 Based on interview, facility documents review, and policy review the facility failed to ensure four of four staff (Registered Charge Nurse 3, Registered Nurse (RN)7, RN23 and Patient Care Technician (PCT) 11) were properly trained and competent to use the mechanical lift. The failure to receive proper training of the mechanical lift had the potential for misuse of the equipment causing injury and could affect the 160 in-center patients. Finding include: Review of the personnel files for Registered Nurse Charge Nurse 3, RN7, RN 23 and PCT11 revealed no evidence of training or competency on the use of the mechanical lift. During an interview on 11/29/23 at 12:30 PM the Facility Administrator confirmed there was no documented training or competency in the four employee files on the use of the mechanical lift and there were “several” patients who used the lift at the facility. During an interview on 11/29/23 at 12:40 PM RN 7 confirmed he/she had not had training on the mechanical lift at the current facility. Review of the facility policy, “Guidelines for Use of the Hoyer Lift,” revised 06/20/18 revealed the following: “ ...Training Policy: At hire and annually thereafter, direct patient care staff will receive training on use of the Hoyer Lift. Prior to each use of the Hoyer Lift, staff will follow the 15 Seconds to Safety Hoyer Pre-flight Checklist to ensure the lift is safe for us. Initial and annual training must include the 15 Seconds to Safety Hoyer Preflight Checklist. Additional training materials may include Hoyer User instruction Manual Training ...””

“GOV-INTERNAL GRIEVANCE SYS ID/IMPLEMENTED CFR(s): 494.180(e) The facility’s internal grievance process must be implemented so that the patient may file an oral or written grievance with the facility without reprisal or denial of services. The grievance process must include- (1) A clearly explained procedure for the submission of grievances. (2) Timeframes for reviewing the grievance. (3) A description of how the patient or the patient’s designated representative will be informed of steps taken to resolve the grievance. This Standard is not met as evidenced by: 28297 Based on interview, review of the “Grievance Report Summary,” review of the “Quality Assessment and Performance Improvement (QAPI)” report, and policy review, the facility failed to follow up on reported grievances in a timely manner for two of 15 sampled (Patients(P) 3 and P4). The failure to follow up on grievance in a timely manner had the potential for missed opportunities for improved care and could affect the 160 in-center patients. Finding include: Review of the “Grievance Report Summary,” from June 2023 through November 2023 revealed the following: 1.On 07/05/23 P3 called a grievance into the Social Worker regarding “Short staffing.” There was no documentation of a resolution or follow-up with the patient as of 11/28/23. 2. On 09/28/23 P4 spoke with the previous Social Worker via a phone call regarding “Being disrespected by a staff member ...” There was no documentation of a resolution or a follow-up with the patients as of 11/29/23. Review of the “QAPI” report for October 2023 revealed both grievances had been reported in the documentation however there was no documentation of any follow up with the patient or resolution as of 11/28/23. During an interview on 11/28/23 at 10:30 AM the Social Worker confirmed both grievances for P3 and P4 had not been followed up on by him/her or the Facility Administrator. During an interview on 11/28/23 at 3:30 PM the Facility Administrator confirmed there was no follow-up with P3 and P4 regarding their grievances. During an interview on 11/29/23 at 10:45 AM the Social Worker stated “We rely on communication with each other to pass the word along. I discussed P4’s grievance in October QAI. I got the grievance for P3 and did discuss with the Facility Administrator at the time and don’t really know why there was no follow up until 11/28/23.” Review of the “Patient Grievance Procedure,” revised 04/04/14 revealed the following: “Responding to Grievances Facility level ... FKC Staff promptly acknowledges and reports all patient grievances to the Nurse in Charge (or Team Leader) as soon as possible. The Nurse in Charge (or Team Leader) meets with the patient to gather information, and completes as many fields as possible on the Patient Grievance Status Report within 72 hours of being notified and informs the CM. The CM reviews the Patient Grievance Status Report daily. For any new grievances, CM meets with the patient within 5 business days to acknowledge, investigate and address the grievance. Note: MSW or other staff may also assist in assessing and resolving patient grievances, as appropriate. CM reports back to the patient when a resolution is attained or considered attained by the facility. Note: When the grievance cannot be immediately resolved, the CM must provide the Patient/representative with updates periodically ...””