Davita Northwest Dialysis Center

“POC-VA MONITOR/PREVENT FAILURE/STENOSIS CFR(s): 494.90(a)(5) The patient’s vascular access must be monitored to prevent access failure, including monitoring of arteriovenous grafts and fistulae for symptoms of stenosis. This Standard is not met as evidenced by: 47759 Based on record review, observation, patient interviews, and staff interviews, the facility’s governing body failed to ensure that the clinical staff members complied with the facility’s monitoring protocol put in place for monitoring of arteriovenous grafts and fistulas. This failure places patients at risk for late detection of access failure. Findings Included: On 04/05/2024 at 02:10 p.m., during record review of the facility’s policy titled “Arteriovenous Fistula (AVF) and Arteriovenous Graft (AVG) Vascular Access Care (Policy: 1-04-01) page 1 states “Inspection of the AVF or AVG access includes the following: ...Presence of swelling or edema, Aneurysm and/or pseudoaneurysm, Condition of previous cannulation sites” Page 3 number 13 states “Cannulation sites will be rotated every treatment to avoid deterioration of access or formation of aneurysms.” On 04/03/2024 at 01:00 p.m., during record review of the vascular surgeon’s encounter notes, On encounter date 01/12/2024, Patient A was “referred for a consultation for pulsatile masses of the right forearm loop AV graft. ... There has been progressive enlargement of the two pulsatile masses. [Under Extremities]: Two moderately large pseudoaneurysms are present, medial one larger than lateral.” On 04/05/2024 at 01:20 p.m., during review of the nurse monthly progress notes created by Staff #8 and Staff #9 for 01/2024, 02/2024, and 03/2024, it states “Support maintenance and functioning of permanent dialysis access ...N/A planned completion” and no comment was made on how one will achieve this plan. At 01:30 p.m., upon review of the treatment flow sheet for Patient A from 12/05/2023-02/26/2024. Under Nurse and Patient Care Technician assessment of patient access site it states, “Continuous bruit/thrill/No signs of impaired skin integrity? Yes” and no additional comment was made. On 04/04/2024 at 03:00 p.m., Staff #11 corroborated that if the access site is not “normal,” one must choose from the category and document such finding. For example: pseudoaneurysm, infiltration, prolonged bleeding. On 04/02/2024-04/05/2024, the surveyor interviewed staff members inquiring about pseudoaneurysms. See interviews below: 1. On 04/02/2024 at 11:40 a.m., Staff #10 stated that “it is not practice to document pseudoaneurysms because almost everyone has one.” 2. On 04/02/2024 at 12:30 p.m., Staff #8 showed the surveyor an example of a pseudoaneurysm in Patient D’s arms and stated that the pseudoaneurysm has not been documented because the pseudoaneurysm has been a chronic pseudoaneurysm. However, the access history revealed no history of the pseudoaneurysm. 3. On 04/05/2024 at 11:00 a.m., Staff #5 confirmed Patient B’s pseudoaneurysm and stated that the access was not huge and will document and notify the nurse once access start to become a problem. 4. On 04/05/2024 at 11:05 a.m., Staff #7 confirmed Patient C’s pseudoaneurysm and stated that Staff #9 has been verbally informed about the pseudoaneurysm, just not documented.”

“QAPI-INDICATOR-MEDICAL INJURIES/ERRORS CFR(s): 494.110(a)(2)(vi) The program must include, but not be limited to, the following: (vi) Medical injuries and medical errors identification. This Standard is not met as evidenced by: 47759 Based on record review, observations, patient interview and staff interview, the facility’s governing body failed to ensure that all staff members are (1) knowledgeable of reportable adverse events occurrences including: Pseudoaneurysm and Infiltrations (2) collecting and aggregating data, and (3) analyzing and reviewing the collected data on Quality Assurance and Performance Improvement (QAPI). This failure places the patients at potential risk for harm. Patient A, B, and C Staff #1, 5, 6 and 7 Findings Included: On 04/05/2024 at 02:00 p.m., during review of the facility’s policy titled “Risk Event Reporting Policy (Non-Teammate related” (Policy 13-01-02) Page 1 number 2 states “All risk events will be promptly reported to the Facility Administrator/Manager or designee ...The teammate will complete the Risk Event Management (REM) Report as soon after the occurrence as is reasonably possible, but no later than the completion of the teammates’ shift during which the risk event happened.” On page 2 number 3 states, “Risk Event Management (REM) Reports are to be trended and reviewed during the Facility Health Meeting (FHM). Page 5 lists examples of reportable risk events. Under known or suspected, it states “Aneurysm, pseudoaneurysm ...infiltration, able to dialyze or treat and/or infiltration, unable to dialyze or treat. “ On 04/02/2024, from 12:41 p.m-01:00 p.m., interviews with Staff #1 and Staff #6 confirmed that an infiltration with Patient A’s access occurred approximately around December 2023. At 12:41 p.m., interview with Staff #1 confirmed Patient A’s progressive pseudoaneurysm enlargement and knowledge of the patient’s pseudoaneurysm for months. Upon review of the facility’s Adverse Event documentation, no event was documented for Patient A related to pseudoaneurysm or infiltration. On 04/02/2024 at 12:30 p.m. during observations on the treatment floor, the surveyor observed 1 patient with a pseudoaneurysm, Patient D. This finding was confirmed by Staff #8 who confirmed Patient D’s pseudoaneurysm. On a similar manner, on 04/05/2024, at 11:00 a.m., during observations on the treatment floor, the surveyor observed 2 additional patients with a pseudoaneurysm, Patient B and C. To confirm this finding, the surveyor interviewed Staff #5 and #7, who both confirmed Patient B and C’s pseudoaneurysm. Upon review of the facility’s Adverse Event documentation, no event was documented for Patient B,C, or D related to the pseudoaneurysm On 04/05/2024 at 01:15 p.m., upon review of the facility’s Adverse Event and Quality Assurance and Performance Improvement (QAPI), the surveyor observed that the governing body failed to collect and aggregate data related to pseudoaneurysm events and therefore lacked the ability to identify opportunities for improvement. When the Manager of Clinical Services (MCS) was provided with the information, the MCS corroborated that the facility will have to perform an inservice on proper cannulation techniques with an emphasis on rotation to prevent pseudoaneurysms.”

“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: 47759 Based on record review and staff interviews, the facility’s governing body failed to provide timely competency training to 27% (6 out of 22) of the staff members. This failure denied patients their rights to a minimum standard of medical care. Findings Included: On 04/05/2024, at 01:22 p.m., during interviews with the Manager of Clinical Services (MCS), the surveyor asked the MCS how the facility demonstrates competency and how the facility maintains and sustains skills. Per the MCS, the facility uses the annual skills checklist On 04/05/2024 at 01:25 p.m., during review of the facility’s personnel file, 6 out of 22 staff members did not have an updated “Annual Skills Checklist.” The Facility Administrator corroborated that 6 out of the 22 staff members had outdated Annual Skills Checklist.”

“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: 47759 Based on observations and record review, the facility’s governing body failed to ensure that the clinical staff took adequate measures in order to prevent the transmission of infectious organisms and the possibility of exposure from contaminants. This failure placed the welfare and safety of patients and staff at potential risk of harm. Findings Included: On 11/20/2023, at 08:50 a.m., the surveyor noted that according to the facility’s policy Infection Control for Dialysis Facilities (Policy 1-05-01) page 5 number 16, “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.” On 11/14/2023, during observations on the clinical treatment floor, the surveyor observed the following: 1. At 09:30 a.m., two (2) clean dialysis chairs adjacent to the utilized trash bin, 4 patient wheel chairs, supply boxes, empty boxes, 2 brooms, 1 dustpan, dialysate jugs, citric acid jugs were found clustered together located in an area where it says “wheelchair area.” 2. At 10:40 a.m., staff members’ personal items [a book and a black phone] were found located on the counter across station #21 where staff members place their unused supplies. 3. At 10:45 a.m., staff members’ personal items [a book and a green phone] were found located on the counter across near station #7 where staff members place their unused supplies. 4. From 11:00 a.m. - 11:22 a.m., gloves, paper, needle cap and gauze were found scattered on the floor near station #20.”

“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: 47759 Based on observations and a review of the facility’s policies and procedures, the governing body failed to ensure that the clinical staff followed the standard regulations in the cleaning and disinfection of contaminated equipment being used in the facility. This failure placed the patients at potential risk for exposure to blood-borne pathogens and infectious diseases. Staff: #8 and #9 Findings included: On 11/20/2023, at 09:00 a.m.m during record review of the facility’s policy 1-05-01 on “Infection Control for Dialysis Facilities” Page 4 number 13b states, “Dialysis station must be completely vacated by the previous patient before teammates can begin to bring disinfection supplies to the station, clean or disinfect the station and set up for the next patient.” On 11/14/2023, the surveyor noted the following: 1. At 09:22 a.m., Staff #8 started to disinfect the machine at station #3 while the current patient was still in the chair in preparation for the next patient. 2. At 09:24 a.m., Staff #8 started to disinfect the machine at station #2 while the current patient was still in the chair in preparation for the next patient. 3. At 09:50 a.m., Staff #9 started to disinfect the machine at station #5 while the current patient was still in the chair in preparation for the next patient. 4. At 09:55 a.m., Staff #9 started to disinfect the machine at station #4 while the current patient was still in the chair in preparation for the next patient.”

“IC-STAFF EDUCATION-CATHETERS/CATHETER CARE CFR(s): 494.30(a)(2) Recommendations for Placement of Intravascular Catheters in Adults and Children I. Health care worker education and training A. Educate health-care workers regarding the ... appropriate infection control measures to prevent intravascular catheter-related infections. B. Assess knowledge of and adherence to guidelines periodically for all persons who manage intravascular catheters. II. Surveillance A. Monitor the catheter sites visually of individual patients. If patients have tenderness at the insertion site, fever without obvious source, or other manifestations suggesting local or BSI [blood stream infection], the dressing should be removed to allow thorough examination of the site. Central Venous Catheters, Including PICCs, Hemodialysis, and Pulmonary Artery Catheters in Adult and Pediatric Patients. VI. Catheter and catheter-site care B. Antibiotic lock solutions: Do not routinely use antibiotic lock solutions to prevent CRBSI [catheter related blood stream infections]. This Standard is not met as evidenced by: 47759 Based on observations and review of policies and procedures, the facility failed to ensure that staff utilized aseptic technique when accessing central venous catheters. The failure to utilize aseptic technique when accessing central venous catheters increased the risk for serious infection(s) and related patient harm. Staff #10, #12 and #15 Patients #10, #11 and #12 Findings Included: On 11/20/2023 at 09:10 a.m. during record review of the facility ’ s policies and procedure, the surveyor noted that according to the facility’s policy Central Venous Catheter (CVC) with clearguard HD antimicrobial end caps (Procedure 1-04-02 B) page 2, “Perform a 15 second hub scrub every time a CVC is connected or disconnected from the blood lines, such as during line reversal, or if the patient is disconnected during treatment for any reason”; Page 6 number 16 states, “Using aseptic technique, remove each cap. One at a time, disinfect each CVC hub with a new alcohol prep pad. Scrub each CVC hub for 15 seconds including the sides and the end of the hub thoroughly...” On 11/14/2023, during clinical observations, the surveyor observed the following: 1. At 10:01 a.m., during treatment termination, staff #10 disconnected the blood line from Patient #10’s CVC line and immediately flushed the CVC line with normal saline without performing a 15 second hub scrub per policy. 2. At 10:25 a.m., during treatment initiation, staff # 15 removed patient # 11’s cvc caps and scrubbed the arterial hub for 9 seconds and the venous hub for 7 seconds. 3. At 11:10 a.m., during treatment initiation, staff # 12 removed patient # 12’s cvc caps, withrew blood with a syringe and flushed the CVC line with normal saline without performing a 15 second hub scrub per policy. The Facility Administrator, who was observing with the surveyor at the time corroborated that Staff #12 did not perform a 15 second hub scrub prior to withrawing and flushing the CVC line.”

“PR-RECEIVE UNDERSTANDABLE INFORMATION CFR(s): 494.70(a)(2) The patient has the right to- (2) Receive all information in a way that he or she can understand; This Standard is not met as evidenced by: 47759 Based on observation, record review and staff and patient interview, the facility’s governing body failed to properly assess and provide information in a way that is individualized for every single patient need.This failure placed the patients at potential risk and denied their rights to a minimum standard of medical care. Findings Included: On 11/20/2023 at 09:00 a.m., during record review, the surveyor observed that on the facility’s policy “Communication with persons with limited english proficiency (LEP).” page 1 letter A states that the facility “will facilitate meaningful communication with LEP patients and the Responsible Parties who are involved in a patient’s medical care and treatment. This includes the communication of information contained in Vital Documents, including but not limited to, waivers of rights, consent to treatment forms, and financial and insurance benefit forms. Page 1 letter C states “ Language assistance services will be provided either through: (i) use of a teammate who is a Qualified Interpreter; or (ii) use of a formal contractual arrangement with an approved external vendor providing Interpretation or Translation services. All teammates will be provided notice of this policy and procedure, and teammates that may have direct contact with LEP individuals will be trained in effective communication techniques, including the effective use of a Qualified Interpreter.” On 11/13/2023 at 10:00 a.m., the surveyor noticed Staff #15 and #18 notifying and educating Patient #10 of [his/her] blood pressure status. At 10:15 a.m., the surveyor then approached Staff #17 who was available at the time and asked if Staff #17 has had Patient #10 as a patient before and what Patient #10’s preferred language was, according to Staff #17, it was English. Based on record review that was conducted with the Facility Administrator, the patient’s preferred language was English. However, based on Staff #17’s interview with Patient #10, witnessed by the surveyor, the patient stated that [his/her] preferred language was Vietnamese.”

“POC-VA MONITOR/PREVENT FAILURE/STENOSIS CFR(s): 494.90(a)(5) The patient’s vascular access must be monitored to prevent access failure, including monitoring of arteriovenous grafts and fistulae for symptoms of stenosis. This Standard is not met as evidenced by: 47759 Based on observations and a review of the facility’s policies and procedures, the facility’s governing body failed to ensure that the clinical staff complied with the appropriate procedures when assessing the patients’ vascular access prior to cannulation and practiced the correct infection control protocol. This failure placed the safety and wellbeing of the patients at potential risk of harm in maintaining their vascular access. Staff #3, #9, #10 and #16 Findings Included: According to the facility’s policy Arterio Venous Fistula (AVF) or Arterio Venous Graft (AVG) Cannulation with Nipro or Medisystems Safety Fistula Needles, procedure 1-04-01 E, page 2 number 5 states “Perform inspection, auscultation and palpation on entire length of access. Determine presence of bruit and thrill.” Page 3 number 13 states “Do not palpate insertion site once area has been prepped.” According to Centers for Disease Control and Prevention (CDC)’s AVF/AVG decannulation observation checklist, one must remove needles aseptically and activate needle retraction device. On 11/14/2023, during observations on the clinical treatment floor, the surveyor observed the following: 1. At 09:45 a.m., during treatment termination, Staff #10 did not use safety needle retraction device upon removal of Patient #19’s AVF/AVG needle. 2. At 10:49 a.m., during treatment initiation, Staff #9 did not listen to the bruit per policies and procedure. Staff #9 disinfected the patient #13’s access site for 11 seconds total and palpated the access prior to cannulation 3. At 11:20 a.m., during treatment initiation, Staff #9 did not listen to Patient #14’s access site with a stethoscope upon assessment. Staff #9 scrubbed Patient #14’s access site for 4 seconds and palpated the access site prior to cannulation twice. This observation was also observed by the Facility Administrator who corroborated the surveyor’s findings. On 11/15/2023, during observations on the clinical treatment floor, the surveyor observed the following: 1. At 09:54 a.m., Staff #3 did not listen to Patient #20’s access site. Staff #3 disinfected the access site, placed a turniquette on the patient’s arms, palpated the site and cannulated. 2. At 10:15 a.m., Staff #16 did not use safety needle retraction device upon removal of patient #21’s AVF/AVG Needle.”

“POC-INITIAL IMPLEMENTED-30 DAYS/13 TX CFR(s): 494.90(b)(2) Implementation of the initial plan of care must begin within the latter of 30 calendar days after admission to the dialysis facility or 13 outpatient hemodialysis sessions beginning with the first outpatient dialysis session. This Standard is not met as evidenced by: 47759 Based on medical records reviewed and interviews with facility’s administrative staff, the governing body failed to ensure that initial nursing assessments were performed by the assigned RN prior to the patients’ initial dialysis treatment when being admitted to the facility.This failure placed the affected patient at risk for receiving insufficient and ineffective care and denied the patient’s rights. Patient: #3, #6 and #8 Findings included: A nursing assessment consists of weight (pre and post), includes a physical examination, the measurement of vital signs, observation of the vascular access and assessment of a patient’s general condition. It also includes a neurological assessment of the level of alertness and the mental status of the patient, subjective complaints, pain status, activity levels, assessment of the respirations, including auscultation of breath sounds; assessment of cardiac status to include auscultation of the heart sounds, fluid gains, skin color and temperature, and bowel sounds. The RN on duty must make and document an initial assessment of the newly-admitted patient prior to his or her first treatment. On 11/16/2023 at 09:30 a.m., upon review of 9 randomly-selected patients’ medical charts, it was noted that 3 out of 9 (33%) of the charts either had an incomplete initial nursing assessment or did not have an initial nursing assessment performed by the assigned RN prior to the patient being dialyzed on their first day of admission to the facility. 1. Patient #8 was admitted to the facility on 01.03.2023. Upon review of patient #8’s chart, the surveyor observed that nurse’s signature was left blank on Patient #8’s initial nursing assessment. The Facility Administrator was informed that, given that there was no signature, the documentation was incomplete. 2. Patient #3 was admitted to the facility on 01.12.2023. Upon review of Patient #3’s chart, the surveyor observed that the nurse’s signature was left blank on the patient’s initial nursing assessment. The Facility Administrator was informed that, given that there was no signature, the documentation was incomplete. 3. Patient #6 was admitted to the facility on 04.21.2023. Upon request of Patient #6’s initial nursing assessment, no documentation could be presented by staff upon request for review.”

“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: 47759 Based on record review and staff interview, the facility’s governing body failed to conduct effective exercises to test the emergency plan annually. This failure places the patients at potential risk of harm during an emergency. Findings Included: On 11/20/2023, at 08:45 a.m., based on record review of the facility’s emergency management plan (EMP), Policy 4-07-01, the surveyor noted that on page 28 number 3 states “Fire safety drills are: ... b. required on a quarterly basis c. one drill to be conducted for each shift of patients ...e. Include patient emergency takeoff procedure, Policy: Termination of Dialysis in an Emergency f. document training for both teammates and patients” Page 27 number 2 letter e states “The facility will conduct and/or participate in one (1) exercise to test the facility EMP at least annually, conducted on opposite years (one year full-scale exercise, next year facility-based / exercise of choice)” On 11/13/2023 at 02:00 p.m., record review of the facility’s mock and fire drill revealed the following: 1. The facility’s most recent fire drill was 10/31/2022. On 11/20/2023, at 02:10 p.m., during staff interview, the Facility Administrator corroborated that fire drills are to be done quarterly. In interviews conducted on 11/15/2023 and 11/16/2023, 7 out of the 7 staff members interviewed stated that the facility has not had a fire drill for the year 2023. 2. The facility’s most recent mock drill was 10/03/2023. However, upon further review of the facility’s mock drill in-service, the surveyor noted that 8 out of the 30 (26%) staff members attended the mock drill. In interviews conducted on 11/15/2023 and 11/16/2023, 5 out of the 7 staff members interviewed stated that they have not had a mock drill for the year 2023.”

“ESRD Patient Orientation Training CFR(s): The dialysis facility must provide appropriate orientation and training to patients, including the areas specified in paragraph (d)(1) of this section. This Standard is not met as evidenced by: 47759 Based on record review and a patient interview, the facility’s governing body failed to educate and train patients how to safely disconnect themselves from the machine. This failure placed the safety and well-being of the patients at potential risk of harm in the event of an emergency evacuation. Patients #1, #6, #8, and #9 Findings Included: In case of emergencies, in order to minimize the risk of injury and bleeding, patients must have proper emergency preparedness training. In the training, the facility must inform patients how to disconnect themselves from the dialysis machine. On 11/20/2023, at 08:50 a.m., based on record review of the facility’s emergency management plan Policy 4-07-01, the surveyor noted that on page 26 number 2b states “teammates are responsible to: provide clear instructions to the patients: i. What to do in an emergency ...ii. Where to go in an emergency ...” On 11/16/2023 at 09:30 a.m. during record review of the selected patient’s Dialysis Emergency Procedure education sheet, a method the facility uses to educate and evaluate patient’s ability to take themselves off the machine in case of an emergency, 4 out of the 9 (44%) selected patients had either incomplete or unfilled but signed sheets. 1. Patients #1, #6 and #9’s Dialysis Emergency Procedure document had an unfilled “Evaluation of activities” and “teammate to review with patient” portion. 2. Patient #8’s Dialysis Emergency Procedure document had an unsigned Teammate Signature and therefore incomplete, lacking verification of the staff member. On 11/15/2023 at 03:15 p.m., during interview with Patient #6, the surveyor asked the patient “Do you know how to take yourself off the machine in case of an emergency? Did you receive education?” The patient stated “No I do not know how” and denied being educated on how to take himself off the machine. This interview was witnessed by Staff #7.”

“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: 47759 Based on observations, the facility’s governing body failed to ensure a dialysis facility that is constructed, equipped, and maintained to provide dialysis patients and staff a safe and functional environment. This failure placed the staff and patients at potential risk of harm in case of an emergency. Findings Included: 1. On 11/15/2023, at 03:00 p.m., during observations of the facility’s treatment floor, the surveyor noted the following: a. Lack of emergency hand cranks at stations #1, 3, 4, 5, 6, 7, 9, 16, 17, 19 and 20. 2. On 11/15/2023, at 01:00 p.m., during a staff interview with a staff member who requested to be anonymous; the surveyor discovered that there are problems with the blood pump rotor. According to the anonymous staff member, during the previous power outage that occurred in October 2023, upon proceeding with the manual blood return, the staff discovered that some of the machine’s blood pump rotor was stuck and therefore difficult to maneuver. The surveyor then asked the anonymous staff member if the staff members were able to assist all patients with blood return. The staff member stated “yes, everyone was able to get their blood back. It was just hard.” The biomedical technician was interviewed about the blood pump rotor and the surveyor was informed that the facility has ordered the parts and has a pending delivery.”

“QAPI-INDICATOR-MEDICAL INJURIES/ERRORS CFR(s): 494.110(a)(2)(vi) The program must include, but not be limited to, the following: (vi) Medical injuries and medical errors identification. This Standard is not met as evidenced by: 47759 Based on record review and staff interviews, the facility’s governing body failed to record adverse event occurrences as soon as possible after they occur as well as discuss Adverse Events in the facility’s Quality Assurance and Performance Improvement (QAPI). This failure places the patients at potential risk for harm. Findings included: 1. On 11/20/2023, at 08:30 a.m., during record review of the facility’s policies and procedure, the surveyor noted the following: a. According to the facility’s policy, policy 13-01-02 “Risk Event Reporting Policy,” page 1 number 1 “Any unexpected event that is inconsistent with the routine operation of a dialysis facility, routine provision of acute dialysis or ancillary renal-related services may be a risk event.” Page 1 number 2 states “All risk events will be promptly reported to the Facility Administrator/Manager or designee ...The teammate will complete the Risk Event Management (REM) Report as soon after the occurrence as is reasonably possible, but no later than the completion of the teammates’ shift during which the risk event happened.” b. According to the facility ’ s policy, policy 1-14-06 “Continuous Quality Improvement Program,” page 1 number 7 states “The facility will measure, analyze and track quality indicators or other aspects of performance. The program must include, but not limited to, the following: Patient Safety, including: ... review of trends of adverse patient occurrences, review of product, equipment” Page 2 states “Continuous monitoring of the above indicators will be reflected in the meeting minutes. Any area identified as underperforming will be reviewed to identify root causes for underperformance, will have an action plan identified that will result in performance improvement, and will track this change in performance over time to verify improvements are sustained. 2. On 11/17/2023 at 10:00 a.m., record review of patient treatment flow sheets and an interview with the Facility Administrator (FA) revealed that a power failure occurred on 07/28/2023 from approximately 02:00 p.m. -04:00 p.m. a. At 10:45 a.m., record review of the facility’s adverse event log on 07/28/2023 did not document a power outage or a delay in treatment. At 10:53 a.m., the FA corroborated that power failures should have been documented on the adverse event log b. At 10:55 a.m., interview with the FA revealed that the facility’s governing body did not discuss the power outage that occurred on 07/28/2023 which resulted in delay of treatment. The FA corroborated that it should have been discussed and documented in QAPI and monitored given that the event was not the first time a power outage has occurred. c. At 11:00 a.m., record review of the facility’s documents revealed that power outage occured 3 times and has not been discussed in QAPI. Power outage occured on the following dates: 06/26/2023, 07/29/2023, 10/03/2023. Upon review of the facility’s emergency risk level assessment, power outage is graded 1, meaning low risk and has yet been re-evaluated. d. On 11/13/2023 at 02:00 p.m., record review of the facility’s mock and fire drill revealed that fire drill has not been performed since 10/31/2022 and although a mock drill was performed, it was ineffective given that only 8 out of the 30 (26%) staff members attended. Lastly, on 11/20/2023, at 08:50 a.m., record review revealed that not all patients were trained to safely disconnect themselves from the machine in case of an emergency. See Etags 0039 and E0040 for more details.”